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Food and Drug Administration, HHS.
Final order.
The Food and Drug Administration (FDA) is classifying the neuropsychiatric interpretive electroencephalograph (EEG) assessment aid into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
This order is effective March 20, 2014. The classification was applicable beginning July 15, 2013.
Peter Como, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2463, Silver Spring, MD 20993-0002, 301-796-6919.
In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
Section 513(f)(2) of the FD&C Act, as amended by section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144, July 9, 2012, 126 Statute 1054), provides two procedures by which a person may request that FDA classify a device under the criteria set forth in section 513(a)(1). Under the first procedure, the person submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified and, within 30 days of receiving an order classifying the device into class III under section 513(f)(1) of the FD&C Act, the person requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a premarket notification under section 510(k) and then a request for classification under the first procedure, the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence and requests a classification under section 513(f)(2) of the FD&C Act. If the person submits a request to classify the device under this second procedure, FDA may decline to undertake the classification request if FDA identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence with the device or if FDA determines that the device submitted is not of “low-moderate risk” or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed.
In response to a request to classify a device under either procedure provided by section 513(f)(2) of the FD&C Act, FDA will classify the device by written order within 120 days. This classification will be the initial classification of the device. Within 30 days after the issuance of an order classifying the device, FDA must publish a notice in the
In accordance with section 513(f)(1) of the FD&C Act, FDA issued an order on November 18, 2011, classifying the Neuropsychiatric EEG-Based Assessment Aid (NEBA) System for attention-deficit/hyperactivity disorder into class III, because it was not substantially equivalent to a device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, or a device which was subsequently reclassified into class I or class II. On December 8, 2011, Lexicor Medical Technology, LLC, submitted a request for classification of the NEBA System under section 513(f)(2) of the FD&C Act. The manufacturer recommended that the device be classified into class II (Ref. 1).
In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act. FDA classifies devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the de novo request, FDA determined that the device can be classified into class II with the establishment of special controls. FDA believes these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device.
Therefore, on July 15, 2013, FDA issued an order to the requester classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 882.1140 (§ 882.1440).
Following the effective date of this final classification administrative order, any firm submitting a 510(k) premarket notification for a neuropsychiatric interpretive EEG assessment aid will need to comply with the special controls named in the final administrative order.
The device is assigned the generic name neuropsychiatric interpretive electroencephalograph assessment aid,
FDA has identified the following risks to health associated with this type of device and the measures required to mitigate these risks:
FDA believes that the following special controls, in addition to the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness:
1. The technical parameters of the device, hardware and software, must be fully characterized and must demonstrate a reasonable assurance of safety and effectiveness.
a. Hardware specifications must be provided. Appropriate verification, validation, and hazard analysis must be performed.
b. Software, including any proprietary algorithm(s) used by the device to arrive at its interpretation of the patient's condition, must be described in detail in the software requirements specification and software design specification. Appropriate software verification, validation, and hazard analysis must be performed.
2. The device parts that contact the patient must be demonstrated to be biocompatible.
3. The device must be designed and tested for electrical safety, electromagnetic compatibility, thermal, and mechanical safety.
4. Clinical performance testing must demonstrate the accuracy, precision, reproducibility, of determining the EEG-based interpretation, including any specified equivocal zones (cutoffs).
5. Clinical performance testing must demonstrate the ability of the device to function as an assessment aid for the medical condition for which the device is indicated. Performance measures must demonstrate device performance characteristics per the intended use in the intended use environment. Performance measurements must include sensitivity, specificity, positive predictive value, and negative predictive value per the device intended use. Repeatability of measurements must be demonstrated using interclass correlation coefficients and illustrated by qualitative scatter plot(s).
6. The device design must include safeguards to prevent use of the device as a stand-alone diagnostic.
7. The labeling must include the following information:
a. A warning that the device is not to be used as a stand-alone diagnostic.
b. A detailed summary of the clinical performance testing, including any adverse events and complications.
c. The qualifications and training requirements for device users including technicians and clinicians.
d. The intended use population and the intended use environment.
e. Any instructions technicians should convey to patients regarding the collection of EEG data.
f. Information allowing clinicians to gauge clinical risk associated with integrating the EEG interpretive assessment aid into their diagnostic pathway.
g. Where appropriate, validated methods and instructions for reprocessing of any reusable components.
Neuropsychiatric interpretive EEG assessment aids are prescription devices restricted to patient use only upon the authorization of a practitioner licensed by law to administer or use the device. (Proposed § 882.1440(a); see section 520(e) of the FD&C Act (21 U.S.C. 360j(e)) and § 801.109 (21 CFR 801.109) (Prescription devices).) Prescription-use restrictions are a type of general controls as defined in section 513(a)(1)(A)(i) of the FD&C Act.
Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the FD&C Act if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device. Therefore, this device type is not exempt from premarket notification requirements. Persons who intend to market this type of device must submit to FDA a premarket notification prior to marketing the device, which contains information about the neuropsychiatric interpretive EEG assessment aid they intend to market.
The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore,
This final administrative order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120, and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485.
The following reference has been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and is available electronically at
Medical devices, Neurological devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 882 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
(a)
(b)
(1) The technical parameters of the device, hardware and software, must be fully characterized and must demonstrate a reasonable assurance of safety and effectiveness.
(i) Hardware specifications must be provided. Appropriate verification, validation, and hazard analysis must be performed.
(ii) Software, including any proprietary algorithm(s) used by the device to arrive at its interpretation of the patient's condition, must be described in detail in the software requirements specification and software design specification. Appropriate software verification, validation, and hazard analysis must be performed.
(2) The device parts that contact the patient must be demonstrated to be biocompatible.
(3) The device must be designed and tested for electrical safety, electromagnetic compatibility, thermal, and mechanical safety.
(4) Clinical performance testing must demonstrate the accuracy, precision, reproducibility, of determining the EEG-based interpretation, including any specified equivocal zones (cutoffs).
(5) Clinical performance testing must demonstrate the ability of the device to function as an assessment aid for the medical condition for which the device is indicated. Performance measures must demonstrate device performance characteristics per the intended use in the intended use environment. Performance measurements must include sensitivity, specificity, positive predictive value, and negative predictive value per the device intended use. Repeatability of measurements must be demonstrated using interclass correlation coefficients and illustrated by qualitative scatter plot(s).
(6) The device design must include safeguards to prevent use of the device as a stand-alone diagnostic.
(7) The labeling must include the following information:
(i) A warning that the device is not to be used as a stand-alone diagnostic.
(ii) A detailed summary of the clinical performance testing, including any adverse events and complications.
(iii) The qualifications and training requirements for device users including technicians and clinicians.
(iv) The intended use population and the intended use environment.
(v) Any instructions technicians should convey to patients regarding the collection of EEG data.
(vi) Information allowing clinicians to gauge clinical risk associated with integrating the EEG interpretive assessment aid into their diagnostic pathway.
(vii) Where appropriate, validated methods and instructions for reprocessing of any reusable components.
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce the special local regulations in 33 CFR 100.1101 during the California Half Ironman Triathlon, held on March 29, 2014. This event occurs in Oceanside Harbor, Oceanside, CA. These special local regulations are necessary to provide for the safety of the participants, crew, spectators, sponsor vessels of the triathlon, and general users of the waterway. During the enforcement period, persons and vessels are prohibited from entering into, transiting through, or anchoring within this regulated area unless authorized by the Captain of the Port, or his designated representative.
This rule is effective from 6:40 a.m. to 9:30 a.m. on March 29, 2014.
If you have questions on this notice, call or email Petty Officer Bryan Gollogly, Waterways Management, U.S. Coast Guard Sector San Diego, CA; telephone (619) 278-7656, email
The Coast Guard will enforce the special local regulations in 33 CFR 100.1101 in support of the annual marine event, the California Half Ironman Triathlon (Item 2 on Table 1 of 33 CFR 100.1101), held
Under the provisions of 33 CFR 100.1101, persons and vessels are prohibited from entering into, transiting through, or anchoring within this regulated area unless authorized by the Captain of the Port, or his designated representative. The Coast Guard may be assisted by other Federal, State, or local law enforcement agencies in enforcing this regulation.
This notice is issued under authority of 5 U.S.C. 552(a) and 33 CFR 100.1101. In addition to this notice in the
If the Captain of the Port Sector San Diego or his designated representative determines that the regulated area need not be enforced for the full duration stated on this notice, he or she may use a Broadcast Notice to Mariners or other communications coordinated by the event sponsor to grant general permission to enter the regulated area.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone around the blasting and dredging project taking place in Portland Harbor between Portland and South Portland, Maine. This safety zone is required to protect users of the waterway from the safety hazards associated with this blasting and dredging project, which is being undertaken to increase the water depth of the main channel to 35 feet. Entry into this safety zone is prohibited unless authorized by the Captain of the Port (COTP) Northern New England.
This rule is effective without actual notice from February 18, 2014 until March 31, 2014. For the purposes of enforcement, actual notice will be used from the date the rule was signed, February 6, 2014, until February 18, 2014.
This rule will be enforced at various dates and times to be determined (TBD) to accommodate dredging and blasting operations, and will be advertised via Local Notice to Mariners and Broadcast Notice to Mariners.
Documents mentioned in this preamble are part of docket [USCG-2014-0010]. To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email Lieutenant Junior Grade Elizabeth Gunn, U.S. Coast Guard, Sector Northern New England, Waterways Management Division, via telephone at (207) 767-0398 or email at
The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 United States Code (USC) 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency, for good cause, finds those procedures are “impracticable, unnecessary, or contrary to the public interest.”
Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because the Army Corps of Engineers (ACOE) notified the Coast Guard of the blasting operations on January 8, 2014. This notice was not received in sufficient time for the Coast Guard to solicit public comments before the start of blasting operations. Consequently, waiting for a comment period to run before publishing this rule would inhibit the Coast Guard's ability to keep the boating public safe and, thus, would be impracticable and contrary to the public interest. Because blasting and dredging operations must be completed by March 15, 2014, in accordance with Maine Department of Environmental Protection (DEP) permitting, it would not be feasible for the project to be delayed or rescheduled. Immediate action is needed to protect the maritime public from the potential hazards associated with blasting operations, which include the use of explosives below the waterline. This regulation is necessary to ensure the immediate safety of users of the waterway.
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
The legal basis for the temporary rule is 33 USC 1226, 1231, 46 USC Chapter 701, 3306, 3703; 50 USC 191, 195; Pub. L. 107-295, 116 Stat. 2064; and Department of Homeland Security Delegation No. 0170.1, which collectively authorize the Coast Guard to define safety zones.
As part of the Maintenance Dredging 35-Foot Channel and Rock Removal Project, the Army Corps of Engineers must blast and dredge in portions of the Portland Harbor near Portland and South Portland, Maine. Due to inherent dangers associated with blasting and dredging operations, a safety zone is necessary to help ensure the safety of the maritime public operating near the work site. The potential explosive arc for each blasting site has been calculated to be approximately 600 feet.
The project is also required to comply with applicable state laws.
The Coast Guard is establishing a temporary safety zone on the navigable waters, from the surface to the bottom of Portland Harbor, in the vicinity of the Army Corps of Engineers' Maintenance Dredging 35-Foot Channel and Rock Removal Project work site between Portland and South Portland, Maine, from the Portland Fish Pier at 43°39′03″ N, 70°15′09″ W across to the Coast Guard Base Pier at 43°38′47″ N, 70°14′53″ W then downstream to the Maine State Pier at 43°39′20″ N, 70°14′48″ W and across to Portland Pipeline Pier 1 at 43°39′11″ N, 70°14′35″ W. This safety zone will encompass multiple blasting sites within a concentrated area of Portland Harbor. The safety zone will be enforced only within 600 feet of each blast site, and only for a short duration of time prior to, during, and after each detonation. Notice of the safety zone enforcement will be advertised via Local Notice to Mariners, Safety Marine Information Broadcast (SMIB) broadcast over Channel 16, and by actual notice on site. Vessels will be able to transit areas outside of the 600 yard radius surrounding each blast site. In addition, vessels may be able to transit through the enforced portions of the safety zone with permission of the COTP or his designated representative. To request permission to transit within the safety zone, the COTP can be contacted via telephone at (207) 767-0303, or by radio on VHF Marine Band Radio, channel 16. The safety zone will be in effect from 12:01 a.m. on February 10, 2014 to 11:59 p.m. on March 31, 2014.
We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on these statutes and executive orders.
This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders. The Coast Guard has made this determination based primarily on the fact that maritime traffic will be allowed to transit the safety zones with permission from the COTP so there should be little to no economic impact. Further, the safety zone will only be enforced for short durations before and during the actual blasting activity.
The Regulatory Flexibility Act of 1980 (RFA), 5 USC 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 USC 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. The following entities may be affected by this rule, some of which may be small entities: The owners and operators of vessels intending to operate, transit, or anchor in a portion of Portland Harbor during the effective times of the safety zone. The safety zone will not have a significant impact on a substantial number of small entities for the following reasons. The enforcement area of the safety zone will be limited to those areas where actual blasting is taking place. Vessels will be able to transit all other areas inside the safety zone where active blasting activities are not taking place. The Coast Guard will make enforcement notifications via maritime advisories so mariners can adjust their plans accordingly. The safety zone will only be enforced for short durations before and during the actual blasting activity.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule will affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and determined that this rule does not have implications for federalism.
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.
This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
This action is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.
This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves regulations regarding safety zones. This rule is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. This rule involves creation of a temporary safety zone for a limited period of time. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination will be available in the docket where indicated under
Harbors, Marine Safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 USC 1226, 1231; 46 USC 701, 3306, 3703; 50 USC 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(1) “Designated representative” means any U.S. Army Corps of Engineers personnel, any commissioned, warrant, or petty officer of the U.S. Coast Guard, and any member of the Coast Guard Auxiliary who has been designated by the Captain of the Port (COTP) Sector Northern New England, to act on the COTP's behalf.
(2) “Official patrol vessel” means any Coast Guard, Coast Guard Auxiliary, Army Corp of Engineers, state, or local law enforcement vessel assigned or approved by the COTP.
(c)
(d)
(2) Entry, transit, diving, dredging, dumping, fishing, trawling, conducting salvage operations, remaining or anchoring within a 600 foot radius of blasting operations within the safety zone is prohibited unless authorized by the COTP.
(3) Upon being hailed by a U.S. Coast Guard vessel, U.S. Army Corps of Engineers vessel or a designated representative, by siren, radio, flashing light, or other means, the operator of a vessel shall proceed as directed.
(4) Vessel operators desiring to enter, transit, dive, dredge, dump, fish, trawl, conduct salvage operations, remain within, or anchor within the safety zone must contact the COTP or the designated representative via the Sector Northern New England Command Center by VHF channel 16 or by phone at (207) 767-0303.
(5) Vessel operators given permission to enter or operate in the safety zone must comply with all directions given to them by the COTP or the designated representative.
Coast Guard, DHS.
Final rule.
The Coast Guard is amending several permanent safety zones located in the Eleventh Coast Guard District that are established to protect public safety during annual firework displays. These amendments will standardize the safety zone language, update listed events, delete events that are no longer occurring, add new annual fireworks events, and establish a standardized format using a table to list these recurring annual fireworks events. When these safety zones are activated, and thus subject to enforcement, this rule will limit the movement of vessels within the established firework display area.
This rule is effective March 20, 2014.
Documents mentioned in this preamble are part of docket USCG-2013-0362. To view documents mentioned in this preamble as being available in the docket, go to
If you have questions about this rule, call or email Lieutenant Junior Grade Blake Morris, Eleventh Coast Guard District Prevention Division, Waterways Management Branch, U.S. Coast Guard; telephone 510-437-3801, email
On December 10th, 2013, we published a NPRM entitled Eleventh Coast Guard District Annual Fireworks Events, in the
The comment that was received stressed that public safety should be the first priority during any fireworks event, making it necessary for the Coast Guard to establish and enforce safety zones that are apparent and clear to the public. The author also believes better clarity can be achieved by using standardized language when publishing regulations.
The Coast Guard is conducting this rulemaking under the authority of 33 U.S.C. 1231.
Fireworks displays are held annually on a recurring basis on the navigable waters within the Eleventh Coast Guard District. Many of the annual fireworks events that require safety zones do not currently reflect some of the required information pertinent to the events such as the dates of the events and other required information that is described below. These safety zones are necessary to provide for the safety of the crew, spectators, participants in the event, participating vessels, and other users and vessels of the waterway from the hazards associated with firework displays. This rule will also provide the public with current information on safety zone locations, size, and length of time the zones will be active.
The effect of these safety zones will be to restrict general navigation in the vicinity of the events, from the start of each event until the conclusion of that event. Except for persons or vessels authorized by the Coast Guard Patrol Commander, no person or vessel may enter or remain in the regulated area. These regulations are needed to keep all spectators and vessels a safe distance away from the fireworks displays.
We received one comment and no requests for a public meeting after publishing the NPRM for this rule. The comment that was received stressed that public safety should be the first priority during any fireworks event, making it necessary for the Coast Guard to establish and enforce safety zones that are apparent and clear to the public. The comment was not adverse in nature, therefore, no changes have been made to the regulatory text of this rule.
The Coast Guard has reviewed 33 CFR part 165 sections 1123, 1124, and 1191 for accuracy. The Coast Guard is amending Table 1 in sections 1123, 1124, and 1191 of Title 33 CFR as follows: existing events are being updated with current information; unlisted events are being added; and listed events that the Coast Guard has been unable to verify as still in existence are being deleted.
The Coast Guard is amending the annual fireworks events for the San Diego Captain of the Port zone listed in 33 CFR part 165 section 1123 as follows: 4 events require updating to reflect current sponsor information and event location. These events are the “San Diego CA POPS Fireworks Display”, “Fourth of July Fireworks, Mission Bay”, “Coronado Glorietta Bay Fourth of July Fireworks”, and “San Diego Parade of Lights Fireworks Display.” Through this rulemaking, three new safety zones are being added for the following events. The first new safety zone is for the “Big Bay Boom Fourth of July Fireworks” event occurring one evening during the first week of July in San Diego Bay. This event requires four 1,000 foot radius safety zones around barges located at Shelter Island, Harbor Island, Embarcadero, and Seaport Village. The second new safety zone is for the “MIDWAY Fireworks” event occurring on various evenings throughout the year on the USS MIDWAY in San Diego Bay. The safety zone will be 800 feet in radius around a barge located immediately to the west of the USS MIDWAY at approximately 32 42′46″ N, 117 10′47″ W. The third new safety zone is for the “Sea World Fireworks” event in Mission Bay occurring nightly between Memorial Day and Labor Day, and on approximately 10 evenings between Labor Day and Memorial Day. The safety zone at Sea World, Mission Bay, will be 800 feet in radius around a barge located at approximately 32 46′03″ N, 117 13′11″ W. Sea World Fireworks events will also be scheduled between Thanksgiving and New Year's Day as conditions allow.
The Coast Guard is amending the annual fireworks events listed in 33 CFR 165 section 1124 within the San Diego Captain of the Port zone for the Colorado River, between Davis Dam (Bullhead City, AZ) and Headgate Dam (Parker, AZ) as follows: 4 events require updating with current sponsor information and event locations. These events are the “Avi Resort & Casino Memorial Day Fireworks”, “Laughlin/Bullhead City Rockets Over the River Fireworks”, “Avi Resort & Casino Independence Day Fireworks”, and the “Avi Resort & Casino Labor Day Fireworks.” Through this rulemaking, two new safety zones are being added for the following events. The first new safety zone is for the “Colorado Belle & Edgewater Hotel/Casino Thanksgiving Fireworks” event occurring in the lower Colorado River at Laughlin, NV. The safety zone will encompass the following coordinates: 35 09′51″ N, 114 34′08″ W; 35 09′53″ N, 114 34′15″ W along the shoreline to 35 09′31″ N, 114 34′17″ W; 35 09′33″ N, 114 34′08″ W along the shoreline to 35 09′51″ N, 114 34′08″ W. The second new safety zone is for the “Colorado Belle & Edgewater Hotel/Casino New Years Eve Fireworks” event occurring on the lower Colorado River at Laughlin, NV. The safety zone will encompass the following coordinates: 35 09′51″ N, 114 34′08″ W; 35 09′53″ N, 114 34′15″ W along the shoreline to 35 09′31″ N, 114 34′18″ W; 35 09′33″ N, 114 34′08″ W along the shoreline to 35 09′51″ N, 114 34′08″ W.
The Coast Guard is amending the annual fireworks events listed in 33 CFR 165 section 1191 within the San Francisco Captain of the Port zone for the Northern California and Lake Tahoe Area as follows: 14 events require updating to reflect current sponsor information and event location. The Coast Guard is updating the following 14 numerically listed events in Table 1 of this section: (1), (4), (5), (6), (7), (9), (11), (13), (14), (15), (16), (20), (24), (25). Through this rulemaking, two new safety zones are being added for the following events. The first new safety zone is for the “Jameson Beach Fourth of July Fireworks” event, occurring at South Lake Tahoe near Jameson Beach. This safety zone will be 560 feet in radius around the fireworks barge. The second new safety zone is for the “Feast of Lanterns Fireworks” event, occurring on the last Saturday in July near Lovers Point Park in Pacific Grove. This safety
We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on these statutes and executive orders.
This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders. We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation is unnecessary. This rule is not a significant regulatory action because the regulations exist for a limited period of time on a limited portion of the waterways. Further, individuals and vessels desiring to use the affected portion of the waterways may, upon permission from the Patrol Commander, use the affected areas.
The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received no comments from the Small Business Administration on this rule. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule would not have a significant economic impact on a substantial number of small entities.
We expect this rule will affect the following entities, some of which may be small entities: The owners and operators of vessels intending to fish, transit, or anchor in the waters affected by these safety zones. This rule will not have a significant economic impact on a substantial number of small entities for the following reasons: Small vessel traffic will be able to pass safely around the area and vessels engaged in event activities, sightseeing and commercial fishing have ample space outside of the area governed by the safety zones to engage in these activities. Small entities and the maritime public will be advised of the activation of these safety zones via public notice to mariners or notice of implementation published in the
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that this rule does not have implications for federalism.
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and would not create an environmental risk to health or risk to safety that might disproportionately affect children.
This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
This rule is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That
This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have concluded that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves establishing, updating, or removing temporary safety zones for fireworks displays. The fireworks are launched from navigable waters of the United States and may have potential for negative impact on the safety or other interest of waterway users and near shore activities in the event area. The activites include fireworks launched from barges near the shoreline that generally rely on the use of navigable waters as a safety buffer to protect the public from fireworks fallouts and premature detonations. This rule is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. A preliminary environmental analysis checklist supporting this determination is available in the docket where indicated under
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1.
Environmental Protection Agency (EPA).
Direct final rule.
The Environmental Protection Agency (EPA) is taking direct final action approving State Implementation Plan (SIP) revisions submitted by the Governor of New Mexico on November 18, 2010, May 24, 2011 and October 11, 2012 on behalf of the Albuquerque-Bernalillo County Air Quality Control Board (AQCB). These revisions serve to incorporate recent changes to the Federal Transportation Conformity and General Conformity rules into the state conformity SIP for Bernalillo County. EPA is approving these revisions in accordance with the requirements of the Federal Clean Air Act (CAA).
This rule is effective on April 21, 2014 without further notice, unless EPA receives relevant adverse comment by March 20, 2014. If EPA receives such comment, EPA will publish a timely withdrawal in the
Submit your comments, identified by Docket No. EPA-R06-OAR-2010-1055, by one of the following methods:
•
• Email: Michelle Peace at
• Mail or delivery: Mr. Guy Donaldson, Chief, Air Planning Section (6PD-L), Environmental Protection Agency, 1445 Ross Avenue, Suite 1200, Dallas, Texas 75202-2733.
The State submittal is also available for public inspection at the State Air Agency listed below during official business hours by appointment:
City of Albuquerque Environmental Health Department, Air Quality Division, Office of Air Quality, One Civic Plaza Northwest, Albuquerque, New Mexico 87103.
Michelle Peace, telephone (214) 665-7430, email
Throughout this document, whenever “we” “us” or “our” is used, we mean the EPA.
Transportation conformity is required under section 176(c) of the Clean Air Act to ensure that Federally supported highway and transit projects are consistent with (conform to) the purpose of the approved SIP. Conformity currently applies to areas that are designated nonattainment, and those areas redesignated to attainment after 1990 (maintenance areas), with plans developed under section 175A of the Clean Air Act for the following transportation related criteria pollutants: Ozone, particulate matter (PM
General conformity is also required under section 176(c) of the Clean Air Act to ensure that all other Federally supported actions outside of highway and transit projects are consistent with the purpose of the approved SIP. General conformity requirements currently apply to the following criteria pollutants: Ozone, particulate matter (PM
States adopt transportation conformity SIPs to enable an area to implement and enforce the Federal transportation conformity requirements per 40 CFR part 51 subpart T and 40 CFR part 93 subpart A. The AQCB initially complied with this requirement by submitting a SIP to EPA on December 19, 1994; we approved this SIP on November 8, 1995 (60 FR 56241). Since the November 8, 1995 approval, the Governor of New Mexico has submitted a number of revisions to the conformity SIP. The most recent of these revisions were submitted on November 18, 2010, and October 11, 2012. The November 18, 2010 submittal consists of amendments to 20.11.3 NMAC, Transportation Conformity reflecting federally promulgated changes that affect PM 2.5 and PM 10 nonattainment and maintenance areas (75 FR 14260). The October 11, 2012 Transportation Conformity submittal includes the current transportation conformity rule that reflects all transportation conformity rulemakings promulgated by EPA as of April 2012, including the Restructuring Amendments final rulemaking (77 FR 14979).
States adopt general conformity SIPs to enable an area to implement and enforce the Federal general conformity requirements per 40 CFR part 51 subpart W and 40 CFR part 93 subpart B. The AQCB initially complied with this requirement by submitting a SIP to EPA on October 1, 2002 and approved by EPA on December 30, 2004 (69 FR 78314). EPA promulgated amendments to the Federal general conformity rule on April 5, 2010 (75 FR 17254). AQCB's May 24, 2011 revision serves to update Albuquerque's regulations found in 20.11.4 NMAC, General Conformity and bring them in line with these most recent changes to the Federal general conformity rule. Because 40 CFR part 51, subpart W (§§ 51.850-51.860) essentially duplicates the regulations promulgated at 40 CFR part 93, subpart B (§§ 93.150-93.160), EPA has deleted all of subpart W except for § 51.851. In the revision to § 51.851, EPA requires that if a state or tribe submits a General Conformity SIP or TIP that it be consistent with the requirements of 40 CFR part 93, subpart B. The EPA added paragraph (f) to 40 CFR 51.851 to allow the states and tribes to develop their own “presumed to conform” list for actions covered by their conformity SIPs or TIPs.” AQCB has not used this provision to develop a “presumed to conform” list for its conformity SIP.
On November 18, 2010 and October 11, 2012, the Governor of New Mexico submitted a revision to the Bernalillo County, New Mexico State Implementation Plan (SIP) for Transportation Conformity purposes. The November 18, 2010 SIP revision consists of language to address the April 23, 2010 federal changes to address PM
On May 24, 2011, The Governor of New Mexico submitted a revision to the Bernalillo County SIP for General Conformity purposes. The SIP revision consists of language to address the April 5, 2010 federal changes to update and streamline the general conformity determination process.
The practice of the AQCB is to incorporate federal language into its local rules and customize such rules to meet the standard required by the New Mexico Administrative Code (NMAC) style guidance, rather than to incorporate by reference the federal rules. This approach is consistent with 40 CFR 51 subparts T and W, which allow a state's conformity SIPs to contain criteria and procedures more stringent than the federal requirements. EPA reviewed the sections of the NMAC found in Tables 1 and 2 for consistency with the Federal Regulations. We found that the revised NMAC sections accurately reflect the current content of corresponding sections of the Federal transportation and general conformity rules they are intended to address, as well as adds specific language to further clarify roles and responsibilities in the Bernalillo County consultation process. Table 1 highlights the sections of NMAC Chapter 20 that were revised to address EPA's March 24, 2010 federal transportation conformity rulemaking (75 FR 14260). Table 2 highlights the sections of NMAC Chapter 20 that were revised to address EPA's March 14, 2012 federal transportation conformity rulemaking (77 FR 14979). Table 3 highlights the sections of NMAC Chapter 20 that correspond to the revisions to the federal general conformity rules which became effective on July 6, 2010. These NMAC revisions are reflected in the AQCB's May 24, 2011 submittal.
The complete federal conformity rules of 40 CFR part 93 and the complete NMAC Chapter can be found at the following Web sites:
EPA is approving the Bernalillo County SIP revisions for Transportation Conformity, which were submitted on November 18, 2010 and October 11, 2012. AQCB's revisions amend rule 20.11.3 NMAC
EPA is publishing this rule without prior proposal because we view this as a non-controversial amendment and anticipate no adverse comments. However, in the proposed rules section of this
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, 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 Order 12866 (58 FR 51735, October 4, 1993);
• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and
• does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.
The Congressional Review Act, 5 U.S.C. section 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 April 21, 2014. 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, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Volatile organic compounds.
40 CFR part 52 is amended as follows:
42 U.S.C. 7401
(c) * * *
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Interim final rule.
On September 12, 2012, the Administrator of the WTC Health Program (Administrator) published a final rule in the
This interim final rule will be effective February 18, 2014. The Administrator invites written comments from interested parties on this interim final rule. Comments must be received by April 21, 2014.
• Federal eRulemaking Portal:
• Mail: NIOSH Docket Office, Robert A. Taft Laboratories, MS-C34, 4676 Columbia Parkway, Cincinnati, OH 45226.
Paul Middendorf, Senior Health Scientist, 1600 Clifton Rd. NE., MS: E-20, Atlanta, GA 30329; telephone (404) 498-2500 (this is not a toll-free number); email
This rule is organized as follows:
The purpose of this action is to amend regulatory language added to 42 CFR 88.1 in paragraph (4) of the definition of “List of WTC-related health conditions” by the final rule published in the
In addition, the Administrator has found it appropriate to reconsider and reverse the WTC Health Program policy to deny certification of cases of malignant neoplasms of the brain (brain cancer) and the pancreas (pancreatic cancer) as WTC-Related Health Conditions. With this rulemaking, these two types of cancer become eligible for certification and Program coverage.
The Administrator is striking the regulatory language indicating that covered cancer types would be specified by medical diagnostic codes (ICD-9
The Administrator is amending the definition of “childhood cancers” to clarify that childhood cancers are any type of cancer diagnosed in a person less than 20 years of age.
The Administrator is amending the definition of “rare cancers” to revise the numeric threshold which determines those cancers which are considered rare. This amendment will result in two additional types of cancer meeting the definition of “rare cancers” and being eligible for coverage—malignant neoplasm of the cervix uteri (invasive cervical cancer) and malignant neoplasm of the testis (testicular cancer). (See discussion in Section IV.B., below.)
The Administrator also announces that he has reviewed and reversed the policy of considering cancers of the brain and the pancreas ineligible for WTC Health Program coverage. With this rule, the Administrator establishes that these two types of cancer will now be considered eligible for coverage as rare cancers.
The total costs and benefits resulting from this regulatory action are due to brain cancer, invasive cervical cancer, pancreatic cancer, and testicular cancer being eligible for coverage by the Program as “rare cancers.” The Administrator estimates the costs of medical treatment for the four cancers now considered eligible under the definition of rare cancers, as well as screening costs associated with invasive cervical cancer, to be between $2,287,933 and $4,933,280 annually for FY 2014 through FY 2016.
Interested persons or organizations are invited to participate in this rulemaking by submitting written views, opinions, recommendations, and/or data. Comments are invited on any topic related to this interim final rule. In addition, the Administrator invites comments specifically on the following question related to this rulemaking:
1. What incidence per 100,000 persons per year in the United States (“incidence rate”) should be used by the WTC Health Program as the threshold for determining whether a type of cancer is rare in relation to the incidence rates for all types of cancer in the U.S. population? Please provide a justification for the suggested incidence rate.
Comments received, including attachments and other supporting materials, are part of the public record and subject to public disclosure. Do not include any information in your comment or supporting materials that you consider confidential or inappropriate for public disclosure. The Administrator will consider the comments submitted and may revise the final rule as appropriate.
Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 (Pub. L. 111-347), amended the Public Health Service Act (PHS Act) to add Title XXXIII
All references to the Administrator of the WTC Health Program in this rule mean the National Institute for Occupational Safety and Health (NIOSH) Director or his or her designee. Section 3312(a)(6) of the PHS Act requires the Administrator to conduct rulemaking to propose the addition of a health condition to the List of WTC-Related Health Conditions (List) codified in 42 CFR 88.1.
On September 7, 2011, the Administrator received a written petition to add a health condition to the List of WTC-Related Health Conditions (Petition 001). Petition 001 requested that the Administrator “consider adding coverage for cancer” to the List of WTC-Related Health Conditions specified in § 88.1. On October 5, 2011, the Administrator formally exercised his option to request a recommendation from the STAC regarding the petition.
The final rule adding certain types of cancer to the List became effective on October 12, 2012 (the addition of prostate cancer became effective October 21, 2013). Since that time, the WTC Health Program has worked to develop guidelines and procedures to incorporate those types of cancers into existing Program health condition certification practices. However, during the first year of implementation, the Program discovered that the complex process of translating the ICD-9 codes to ICD-10 codes has resulted in confusion among Program medical staff and Clinical Centers of Excellence (CCEs) and Nationwide Provider Network physicians. The Administrator finds that the detailed list of ICD codes in Table 1, including sub-codes, is inappropriately restrictive and often results in coding errors. For instance, CCE physicians have at times submitted requests for certification using a different ICD code for the listed cancer type than the Administrator used in Table 1. ICD codes are highly nuanced and, for some cancers, choosing the precise code may be a matter of professional judgment on the part of the physician making a health condition determination. When a physician submits an ICD code that differs from codes included in Table 1, the Administrator must then determine whether the specific code chosen by the physician references a type of cancer that was actually intended to be covered by the Program or could be otherwise correctly characterized. In some instances, the determining physician used a different or more-specific subcode than was included in the List; however, after review, the Administrator agreed that the type of cancer submitted by the physician fits within the intent of the final rule on cancer. A detailed list of sub-codes is unnecessary, confusing to providers, and limits the WTC Health Program's ability to appropriately identify which members' cancers are eligible for certification, therefore, the Administrator is replacing Table 1 with a narrative list of cancer categories.
The Administrator has also identified the need to clarify that childhood cancers are cancers that are first diagnosed in a person under the age of 20 years. The current definition does not clearly indicate that the Administrator has always intended to certify cases of cancer in WTC Health Program members who were under the age of 20 when they were first diagnosed, even though they may be over the age of 20 when they enter the WTC Health Program. The existing language could be interpreted to mean that only a WTC Health Program member under the age of 20 years can be certified for treatment of a WTC-related childhood cancer. The revised language clarifies that a childhood cancer is defined based on age at diagnosis rather than the current age of the WTC Health Program member.
In addition to the detailed list of ICD codes, the Program has also identified problems with the definition of “rare cancers” established in § 88.1.
The Administrator has identified several problems with the definition of rare cancers for the purpose of identifying such conditions for WTC Health Program coverage as specified in 42 CFR 88.1. First, the original definition was derived from the Rare Diseases Act of 2002, which states that, “[r]are diseases and disorders are those which affect small patient populations, typically populations smaller than 200,000 individuals in the United States.”
Second, the Rare Diseases Act establishes the threshold for the number of cases qualifying a disease as rare using “prevalence” (
Third, the “case-by-case basis” text is misleading. There is no case-specific approach to “determine” which cancers would qualify as rare cancers. Rare cancers will be determined based on their incidence as specified in this rule.
In the preamble to the September 12, 2012 final rule, the Administrator concurred with the STAC's decision to not recommend malignant neoplasms of the brain and the pancreas for inclusion on the List of WTC-Related Health Conditions (77 FR 56138, 56147), indicating that no compelling evidence was found to support their inclusion:
The issue of whether to recommend the addition of cancers of the * * * brain and pancreas to the List of WTC-Related Health Conditions was considered and discussed by the STAC in the open meeting on March 28, 2012. In those discussions, the STAC considered the available evidence for recommending the addition of cancers of the * * * brain and pancreas, including the epidemiologic evidence and the NTP [NIH's National Toxicology Program] and IARC reviews. Following its deliberation on the matter, the STAC voted not to include * * * brain or pancreatic cancer in its recommendation. [See STAC (World Trade Center Health Program Scientific/Technical Advisory Committee) Letter from Elizabeth Ward, Chair, to John Howard, MD, Administrator [2012].] The Administrator concurs with the decision of the STAC and is not adding these cancers to the List of WTC-Related Health Conditions at this time. The addition of these cancers may be reconsidered if additional information on the association of 9/11 exposures and those cancer outcomes becomes available.
As a result of that determination, the WTC Health Program denied certification of cancers of the brain and the pancreas, even though they were found to meet the numeric threshold in the definition of rare cancers. After review, the Administrator has reconsidered that decision and determined, for the reasons discussed below, that cancers of the brain and the pancreas will be considered eligible for certification as rare cancers. With this rulemaking, a WTC Health Program member whose 9/11 exposure is found substantially likely to be a significant factor in aggravating, contributing to, or causing the individual's brain and/or pancreatic cancer, will be certified for WTC Health Program treatment services. The WTC Health Program will review and reassess cases of brain and pancreatic cancer that were denied certification prior to this rulemaking.
As noted above, the Administrator asked the STAC to deliberate and develop recommendations on a petition to add cancers to the List of WTC-Related Health Conditions. The STAC met on three occasions between November 2011 and March 2012, and offered its final recommendation to the Administrator on April 2, 2012.
In its April 2, 2012 letter to the Administrator, the STAC formally recommended that the Administrator add rare cancers to the List of WTC Related Health Conditions. According to the STAC:
Excesses in rare cancers are difficult to detect in epidemiologic studies. Even large studies may have very low numbers of expected cases of rare cancers, and thus very low statistical power to detect any but very large effects. In addition, most cancer studies analyze data by organ site, and not by site and histology. This can result in inability to detect rare site and histology combinations, such as angiosarcoma of the liver, associated with vinyl chloride monomer exposure, and small cell carcinoma of the lung, associated with bischloromethyl ether. Cancers can also be defined as rare based on the patient's gender (male breast cancer), age (prostate cancer in men under 40) or race (melanoma in African Americans). Since customary study methods are unlikely to identify increased risks for rare cancers among WTC-exposed populations unless they occur in sizable clusters. Nonetheless, given the sizable number of carcinogens (and related cancer sites) present in WTC smoke and dust, it is reasonable to consider the possibility that an increased risk of specific rare cancers may occur or that the incidence of common cancers would be increased at younger ages in WTC-exposed populations. One approach that has been used is to consider rare cancers as cancers with age-adjusted incidence rates less than 15 per 100,000, which would result in defining 25% of all adult cancers in the US as rare. Additional definitions—10 cases per million per year, or 1 case per million per year—have also been examined.
Further, the STAC specifically referenced an incidence rate of less than 15 cases per 100,000 population to characterize the cancer rate among children as rare.
In the preamble to the September 2012 final rule, the Administrator developed a four-part methodology for evaluating whether to add a type of cancer to the List.
In order to revise the definition of “rare cancers” and develop a threshold better suited to WTC Health Program purposes, the Administrator reconsidered the STAC's recommendation, and evaluated the incidence rates used by research organizations in the United States and Europe, including the North American Association of Central Cancer Registries (NAACCR), the National Institutes of Health (NIH), the International Rare Cancers Initiative (IRCI), the European Society for Medical Oncology (ESMO), and RARECARE.
There is no single, universally agreed-upon, quantitative definition of “rare cancers.” A rarity threshold is a matter on which informed experts differ; established rarity thresholds also depend on the purpose for which the definition is applied. The different thresholds used by the various organizations were developed to stimulate epidemiologic studies and clinical research on rare cancer therapeutics; the Administrator was unable to identify any incidence rate used by any other organizations for purposes similar to the WTC Health Program. The European organizations IRCI, ESMO, and RARECARE use lower incidence thresholds for rare cancers than do researchers in the United States: IRCI uses a threshold of less than or equal to 2 cases per 100,000 persons per year;
The Administrator has determined that the incidence rate used by U.S. researchers—less than 15 cases per 100,000 persons per year in the United States—is most representative of his intent and that of the STAC. The Administrator has further determined that, because incidence rates change from year-to-year, rare cancers will be identified using average annual data from the 2005-2009 period which has been age-adjusted
All types of cancer that are not listed in 42 CFR 88.1 and that meet the threshold of less than of 15 cases per 100,000 persons per year (based on age-adjusted 2005-2009 average annual data)
The revised numeric threshold in the definition of rare cancers will result in two types of cancer becoming newly eligible for consideration as rare cancers. Under the former numeric threshold in the definition of rare cancers (prevalence of fewer than 200,000 persons), malignant neoplasms of the cervix uteri (invasive cervical cancer) and the testis (testicular cancer) were not eligible for coverage because their respective prevalence estimates are greater than the threshold of 200,000 persons in the United States with these conditions. Both invasive cervical cancer and testicular cancer, however, will be considered rare cancers under the new definition because their incidence rates are less than 15 cases per 100,000 persons per year in the United States based on age-adjusted 2005-2009 average annual data.
During a meeting held on March 28, 2012, STAC members discussed
When applying the Administrator's four-part methodology established in the September 12, 2012 final rule, neither cancers of the brain nor the pancreas were found to satisfy any of the four methods.
The rationale provided by the STAC for the inclusion of rare cancers as a category on the List was that there is large uncertainty in associating a rare cancer to a specific exposure. Most rare cancers have not been adequately investigated in epidemiologic studies and the relatively small number of cases of such cancers may preclude epidemiologic study in the future. Moreover, future epidemiologic study of the small number of expected cancer cases in the 9/11-exposed population would be of little help in determining an association between 9/11 exposures and most types of cancer. Although malignant neoplasms of the brain and the pancreas qualify as rare cancers under various numeric thresholds,
At the time of the September 2012 final rulemaking, in accordance with the STAC's stated basis for recommending the inclusion of a rare cancers category (see prior discussion, Section IV.A.), the Administrator had interpreted the presence of many studies addressing brain and pancreatic cancer as an indication that they could be studied, and that associations would be identified if present; he originally determined that those studies indicate that neither cancers of the brain nor the pancreas are associated with the exposures experienced by WTC responders and survivors, and therefore they could not be considered WTC-related.
In the process of revising the definition of rare cancers, the Administrator re-visited the STAC's rationale for including the category of rare cancers. During its March 2012 meeting, the STAC considered the exposure data collected in the days following the September 11, 2001, terrorist attacks, and found it extremely limited. STAC members acknowledged the difficulties in attempting to identify associations between 9/11 exposures and specific cancer types. This sentiment was clearly expressed by the STAC Chair, who stated, “we know something but we don't know everything” with regard to 9/11 exposures.
The Administrator now finds that while brain cancer or pancreatic cancer may be evaluated in a number of epidemiologic studies, the limitations of those studies are substantial, leading the Administrator to conclude that the uncertainties surrounding the causes of brain and pancreatic cancers are not unlike the uncertainties surrounding other rare cancers. The Administrator reviewed epidemiologic studies of brain and pancreatic cancers involving some of the carcinogens involved in 9/11 exposures and identified five significant study limitations: (1) The low frequency of and difficulty in diagnosing cancers of the brain and pancreas;
Upon re-evaluation of these studies, the Administrator finds that brain or pancreatic cancer may be associated with an exposure, but the studies' limitations prevent adequate evaluation of this association. Accordingly, the Administrator has determined that the availability of numerous studies evaluating the associations between brain and pancreatic cancers and environmental exposures should not be given more weight in his decision-making than the inherent limitations of these studies. While the Administrator previously relied on the lack of an identified association between environmental exposures and brain or pancreatic cancers in these epidemiologic studies to conclude that they should not be considered WTC-related, he now determines that those studies are not likely to identify associations because of study limitations and concludes that, because the uncertainty associated with brain and pancreatic cancers is similar to the uncertainty associated with other rare cancers, they should be similarly eligible for consideration as WTC-related.
For the reasons discussed above, the Administrator has determined that brain and pancreatic cancers are considered rare cancers, and that they are eligible for WTC Health Program certification.
Title II of the James Zadroga 9/11 Health and Compensation Act of 2010 (Pub. L. 111-347) reactivated the September 11th Victim Compensation Fund (VCF). Administered by the U.S. Department of Justice (DOJ), the VCF provides compensation to any individual or representative of a deceased individual who was physically injured or killed as a result of the September 11, 2001, terrorist attacks or during the debris removal. Eligibility criteria for compensation by the VCF include a list of presumptively covered health conditions, which are physical injuries determined to be WTC-related health conditions by the WTC Health Program. Pursuant to DOJ regulations, the VCF Special Master is required to update the list of presumptively covered conditions when the List of WTC-Related Health Conditions in 42 CFR 88.1 is updated.
In accordance with the provisions of the Administrative Procedure Act at 5 U.S.C. 553(b)(3)(B), the Administrator finds good cause to waive the use of prior notice and comment procedures for issuing this interim final rule (IFR), and that the use of such procedures would be contrary to the public interest. This IFR amends 42 CFR 88.1 to remove Table 1 and replace it with a narrative list of covered cancers, clarify the definition of childhood cancers, and revise the definition of rare cancers; it also notifies stakeholders that the Administrator now considers malignant neoplasms of the brain and the pancreas to be eligible for coverage as rare cancers. The Administrator has determined that it is contrary to the public interest to delay these necessary amendments. Postponement of the implementation of these amendments could result in real harm to those individuals who are currently suffering from a subtype of cancer that was inadvertently excluded from the detailed list of cancer codes, or from a rare cancer that was not identified by the former prevalence-based numeric threshold (U.S. population size of 200,000 persons), or from cancer of the brain or the pancreas. Thus, the Administrator is waiving the prior notice and comment procedures in the interest of protecting the health of WTC Health Program members whose cancer may now be eligible for certification.
The amendments to replace Table 1 with a narrative list of covered cancers and clarify the definition of childhood cancers will not result in any substantive change to the types of cancers added to the List of WTC-Related Health Conditions by the final rule published on September 12, 2012 (77 FR 56138) or by the final rule published on September 19, 2013 adding prostate cancer (78 FR 57505); however, changing the numeric threshold for rare cancers will result in of two types of cancer becoming newly eligible for consideration as rare cancers. Additionally, cancers of the brain and the pancreas may now be considered for certification as rare cancers. The Administrator expects that most stakeholders will be supportive of the amendments, because the determinations established in this rulemaking will result in more WTC Health Program members becoming eligible for certification of a WTC-
Under 5 U.S.C. 553(d)(3), the Administrator finds good cause to make this IFR effective immediately. As stated above, in order to ensure that the WTC Health Program is able to promptly respond to a member WTC responder or survivor who is suffering from a type of cancer that may now be eligible for certification, including individuals who may have been denied certification for brain or pancreatic cancer, it is necessary that the Administrator act quickly to promulgate the amendments discussed above. While the amendments to § 88.1 are effective on the date of publication of this IFR, they are interim and will be finalized following the receipt of any substantive public comments. (
For the reasons discussed above, the Administrator of the WTC Health Program is amending 42 CFR 88.1, paragraph (4) of the definition of “List of WTC-related health conditions,” to strike the former regulatory language indicating that covered cancer types would be specified by ICD-10 and ICD-9 codes. The rule is further amended to remove Table 1 in its entirety and to replace it with the narrative list of 24 broadly specified cancer types by body organ or region included in both the 2012 notice of proposed rulemaking and final rule preambles, as well as prostate cancer which was added to the List in the September 2013 rulemaking.
For the reasons discussed above, the Administrator clarifying the definition of “childhood cancers” to replace the words “occurring in” with “diagnosed in.”
Finally, the Administrator is also revising the definition of “rare cancers” to remove the 200,000 persons prevalence and 0.08 percent incidence rate in the former definition and instead reflect the revised incidence rate, less than 15 cases per 100,000 persons per year in the United States based on 2005-2009 average annual data.
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility.
This interim final rule has been determined not to be a “significant regulatory action” under sec. 3(f) of E.O. 12866. The amendments in this rule modify the format of the list of named cancers covered by the WTC Health Program, clarify the definition of “childhood cancers,” and modify the definition of “rare cancers.” In addition to amendments to the rule text, in this action the Administrator also recognizes malignant neoplasms of the brain and the pancreas as rare cancers. The revised definition and determinations regarding “rare cancers,” have resulted in four additional cancer types being considered eligible for coverage under the Program: Brain cancer (malignant neoplasm of the brain), invasive cervical cancer (malignant neoplasm of the cervix uteri), pancreatic cancer (malignant neoplasm of the pancreas), and testicular cancer (malignant neoplasm of the testis). Treatment and monitoring services for these four cancer types is estimated to cost the WTC Health Program between $2,287,933
The Administrator did not identify any costs associated with the removal of Table 1 from 42 CFR 88.1.
The rule would not interfere with State, local, and Tribal governments in the exercise of their governmental functions.
The WTC Health Program has, to date, enrolled approximately 58,500 New York City responders and approximately 6,500 survivors, or approximately 65,000 individuals in total. Of that total population, approximately 60,000 individuals were participants in previous WTC medical programs and were `grandfathered' into the WTC Health Program established by Title XXXIII.
As it is not possible to identify an upper bound estimate, the Administrator has modeled another possible point on the continuum. For the purpose of calculating the impact of an increased rate of cancer on the WTC Health Program, this analysis assumes
The Administrator acknowledges that some cancer cases are not likely to have been caused by 9/11 exposures. The certification of individual cancer diagnoses will be conducted on a case-by-case basis. However, for the purpose of this analysis, the Administrator has estimated that all diagnosed cancers added to the List or meeting the definition of rare cancer will be certified for treatment by the WTC Health Program. Finally, because there are no existing data on cancer rates related to 9/11 exposures at either the Pentagon or in Shanksville, Pennsylvania, the Administrator has used only data from studies of individuals who were responders or survivors in the New York City disaster area.
The Administrator estimated the treatment costs associated with covering malignant neoplasm of the brain, malignant neoplasm of the cervix uteri, malignant neoplasm of the pancreas, and malignant neoplasm of the testis in this rulemaking using the methods described below. Costs associated with cancer screening are discussed separately below.
The WTC Health Program obtained data for the cost of providing medical treatment for each cancer type. The costs of treatment for each type of cancer are described in Table A. The costs of treatment are divided into three phases: The costs for the first year following diagnosis, the costs of intervening years or continuing treatment after the first year, and the costs of treatment for the last year of life. The first year costs of cancer treatment are higher due to the initial need for aggressive medical (
These cost figures were based on a study of elderly cancer patients from the Surveillance, Epidemiology, and End Results (SEER) program maintained by the National Cancer Institute using Medicare files.
The Administrator estimated the expected number of cases of cancer that would be observed in a cohort of responders and survivors followed for cancer incidence after September 11, 2001 using U.S. population cancer rates for the four cancer types considered eligible for coverage under the Program pursuant to this rulemaking. Demographic characteristics of the cohort were assigned since the actual data are not available for individuals in the responder and survivor populations who have not yet enrolled in the WTC Health Program. Gender and age (at the time of exposure) distributions for responders and survivors were assumed to be the same as current enrollees in the WTC Health Program. According to WTC Health Program data, males comprise 88 percent of the current responder enrollees and 50 percent of survivor enrollees. Because invasive cervical cancer occurs only in females and testicular cancer only occurs in males, the calculations take into account the applicable gender of the WTC Health Program members for the respective cancer type. The age distribution for current enrollees by gender and responder/survivor status is presented in Table B.
The Administrator assumed race and ethnic origin distributions for responders and survivors according to distributions in the WTC Health Registry cohort:
To determine the potential number of individuals in the responder and survivor populations with cancer, the Administrator used the number of incident cases described above for each year starting with 2002 and estimated the prevalence of cancer using survival rate statistics for each incident cancer group through 2016.
Using the incident cases and survival rate statistics for each cancer type, the Administrator has estimated the prevalence (number of individuals living with cancer) of cases during the 15 year period (2002-2016) since September 11, 2001. The resulting table provides for each year from 2002 through 2016, the number of new cases occurring in that year (incidence), the number of individuals who died from their cancer in that year, and the number of individuals surviving up to 15 years beyond their first diagnosis (prevalence).
Prevalence tables were created for each type of covered cancer and the results are summarized in Tables E and G. This analysis considers cancers diagnosed in 2002 through 2016.
To compute the costs for each type of cancer, the Administrator assumes that all of the individuals who are diagnosed with a cancer type will be certified by the WTC Health Program for treatment services. The treatment costs for the first year of treatment (Table A, year adjusted) were applied to the predicted newly incident (Year 1) cases for each year. Likewise, the costs of treatment for the last year of life were applied in each year to the number of people predicted to die from their cancer in that year. The costs of continuing treatment from Table A were applied to the number of prevalent cases who had survived their cancers beyond their year of diagnosis, for each year of survival (Year 2-15).
Using this procedure, a cost table was constructed for each year covered by the WTC Health Program and the results are presented in Tables D1, D2, D3, and D4. The row for Year 1 in each table is the cost of incident cases for that year. Rows for Years 2-15 show the cost from continuing care for individuals surviving n-years beyond the year of diagnosis. Finally, the cost of last year of life treatment is computed by multiplying the cost for last year of life by the number of individuals dying in that year from that type of cancer from Tables C1-C4.
The sum of the annual costs in each table for the years 2014 through 2016 represents the estimated treatment costs to the WTC Health Program for coverage of brain, invasive cervical, pancreatic, and testicular cancers, respectively, for 80,000 responders. The cost projections in Tables D1, D2, D3, and D4 are based on an assumed responder population size of 80,000.
The same process described above was applied to the survivor cohort. Based on the incidence rate expected from the survivor cohort, prevalence tables were constructed for each covered type of cancer.
The estimated treatment costs for responders and survivors were re-computed under the following two assumptions: (1) The rate of cancer in the WTC Health Program is equal to the rate of cancer observed in the general population; and (2) the rate of cancer exceeds the general population rate by 21 percent due to their 9/11 exposures.
A summary of the estimated prevalence at the U.S. population average for the assumed population of 58,500 responders and 6,500 survivors is provided in Table E. A summary of the estimated treatment costs to the WTC Health Program is provided in Table F.
A summary of the estimated prevalence using cancer rates 21 percent over the U.S. population average for the increased rate of 80,000 responders and 30,000 survivors is given in Table G. A summary of the estimated treatment costs to the WTC Health Program is provided in Table H.
Costs of screening have been added to the summary estimates table below. The screening indicated by this rulemaking follows U.S. Preventive Services Task Force (USPSTF) guidelines. The USPSTF recommends cervical cancer screening but does not recommend screening for brain, pancreatic, or testicular cancer. For cervical cancer, USPSTF recommends that females age 21-65 receive one Pap test every 3 years; females age 30-65, are recommended to receive one HPV screening every 5 years.
Because the Administrator lacks data to account for either recoupment by health insurance or workers' compensation insurance or reduction by either health insurance or Medicare/Medicaid payments, the estimates offered here are reflective of estimated WTC Health Program costs only. This analysis offers an assumption about the number of individuals who might enroll in the WTC Health Program, and estimates the impact of both a low rate of cancer (U.S. population average rate) and an increased rate (21 percent greater than the U.S. population average) on the number of cases and the resulting estimated treatment costs to the WTC Health Program. This analysis does not include administrative costs associated with certifying additional diagnoses of cancers that are WTC-related health conditions that might result from this action. Those costs were addressed in the interim final rule that established regulations for the WTC Health Program (76 FR 38914, July 1, 2011).
After the implementation of provisions of the Patient Protection and Affordable Care Act (Pub. L. 111-148) on January 1, 2014, all of the members and future members can be assumed to have or have access to medical insurance coverage other than through the WTC Health Program. Therefore, all treatment and screening costs to be paid by the WTC Health Program from 2014 through 2016 are considered transfers.
Table I describes the allocation of WTC Health Program transfer payments based on 58,500 responders and 6,500 survivors and, alternatively, 80,000 responders and 30,000 survivors.
This section describes qualitatively the potential benefits of the interim final rule in terms of the expected improvements in the health and health-related quality of life of potential cancer patients treated through the WTC Health Program, compared to no Program. The assessment of the health benefits for cancer patients uses the number of expected cancer cases that was estimated in the cost analysis section.
The Administrator does not have information on the health of the population that may have experienced 9/11 exposures and is not currently enrolled in the WTC Health Program. In addition, the Administrator has only limited information about health insurance and health care services for cancers caused by 9/11 exposures and suffered by any population of responders and survivors, including responders and survivors currently enrolled in the WTC Health Program and responders and survivors not enrolled in the Program. For the purposes of this analysis, the Administrator assumes that broad trends on demographics and access to health insurance reported by the U.S. Census Bureau and health care services for cancer similar to those reported by Ward
Although the Administrator cannot quantify the benefits associated with the WTC Health Program, enrollees with cancer would have improved access to care and thereby the Program should produce better treatment outcomes than in its absence. Under other insurance plans, patients would have deductibles and copays, which impact access to care and particularly its timeliness. WTC Health Program members would have first-dollar coverage and hence are likely to seek care sooner when indicated, resulting in improved treatment outcomes.
The analysis presented here was limited by the dearth of verifiable data on the cancer status of responders and survivors who have yet to apply for enrollment in the WTC Health Program. Because of the limited data, the Administrator was not able to estimate benefits in terms of averted healthcare costs. Nor was the Administrator able to estimate administrative costs, or indirect costs, such as averted absenteeism, short and long-term disability, and productivity losses averted due to premature mortality.
The Regulatory Flexibility Act (RFA), 5 U.S.C. 601
The Paperwork Reduction Act (PRA), 44 U.S.C. 3501
As required by Congress under the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801
Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531
This interim final rule has been drafted and reviewed in accordance with Executive Order 12988, “Civil Justice Reform,” and will not unduly burden the Federal court system. This rule has been reviewed carefully to eliminate drafting errors and ambiguities.
The Administrator has reviewed this interim final rule in accordance with Executive Order 13132 regarding federalism, and has determined that it does not have “federalism implications.” The rule does 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.”
In accordance with Executive Order 13045, the Administrator has evaluated the environmental health and safety effects of this interim final rule on children. The Administrator has determined that the rule would have no environmental health and safety effect on children, although an eligible child who has been diagnosed with any cancer type may seek certification of the condition by the Administrator.
In accordance with Executive Order 13211, the Administrator has evaluated the effects of this interim final rule on energy supply, distribution or use, and has determined that the rule will not have a significant adverse effect.
Under Public Law 111-274 (October 13, 2010), executive Departments and Agencies are required to use plain language in documents that explain to
Aerodigestive disorders, Appeal procedures, Cancer, Health care, Mental health conditions, Musculoskeletal disorders, Respiratory and pulmonary diseases.
For the reasons discussed in the preamble, the Department of Health and Human Services amends 42 CFR Part 88 as follows:
42 U.S.C. 300mm—300mm-61, Pub. L. 111-347, 124 Stat. 3623.
(4) Cancers:
(i) Malignant neoplasms of the lip, tongue, salivary gland, floor of mouth, gum and other mouth, tonsil, oropharynx, hypopharynx, and other oral cavity and pharynx.
(ii) Malignant neoplasm of the nasopharynx.
(iii) Malignant neoplasms of the nose, nasal cavity, middle ear, and accessory sinuses.
(iv) Malignant neoplasm of the larynx.
(v) Malignant neoplasm of the esophagus.
(vi) Malignant neoplasm of the stomach.
(vii) Malignant neoplasm of the colon and rectum.
(viii) Malignant neoplasm of the liver and intrahepatic bile duct.
(ix) Malignant neoplasms of the retroperitoneum and peritoneum, omentum, and mesentery.
(x) Malignant neoplasms of the trachea; bronchus and lung; heart, mediastinum and pleura; and other ill-defined sites in the respiratory system and intrathoracic organs.
(xi) Mesothelioma.
(xii) Malignant neoplasms of the peripheral nerves and autonomic nervous system, and other connective and soft tissue.
(xiii) Malignant neoplasms of the skin (melanoma and non-melanoma), including scrotal cancer.
(xiv) Malignant neoplasm of the female breast.
(xv) Malignant neoplasm of the ovary.
(xvi) Malignant neoplasm of the prostate.
(xvii) Malignant neoplasm of the urinary bladder.
(xviii) Malignant neoplasm of the kidney.
(xix) Malignant neoplasms of the renal pelvis, ureter and other urinary organs.
(xx) Malignant neoplasms of the eye and orbit.
(xxi) Malignant neoplasm of the thyroid.
(xxii) Malignant neoplasms of the blood and lymphoid tissues (including, but not limited to, lymphoma, leukemia, and myeloma).
(xxiii) Childhood cancers: Any type of cancer diagnosed in a person less than 20 years of age.
(xxiv) Rare cancers: any type of cancer
Coast Guard, DHS.
Notice of Proposed Rulemaking.
The Coast Guard proposes to establish a temporary safety zone for a portion of Bayou Grande, Pensacola, FL. This action is necessary for the protection of persons and vessels, on navigable waters, during the landing of a large sea plane. Entry into, transiting in or anchoring in this zone is prohibited to all vessels, mariners, and persons unless specifically authorized by the Captain of the Port (COTP) Mobile or a designated representative.
Comments and related material must be received by the Coast Guard on or before March 5, 2014.
You may submit comments identified by docket number USCG-2013-1075 using any one of the following methods:
(1)
(2)
(3)
See the “Public Participation and Request for Comments” portion of the
If you have questions on this proposed rule, call or email LT Stanley A. Tarrant, Coast Guard Sector Mobile, Waterways Management Division; telephone (251) 441-5940 or email Stanley.A.Tarrant@uscg.mil. If you have questions on viewing or submitting material to the docket, call Cheryl F. Collins, Program Manager, Docket Operations, telephone 202-366-9826.
We encourage you to participate in this rulemaking by submitting comments and related materials. All comments received will be posted without change to
If you submit a comment, please include the docket number for this proposed rulemaking (USCG-2013-1075), indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online at
To submit your comment online, go to
If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8
To view comments, as well as documents mentioned in this preamble as being available in the docket, go to
Anyone can search the electronic form of comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review a Privacy Act notice regarding our public dockets in the January 17, 2008, issue of the
We do not now plan to hold a public meeting. But you may submit a request for one, using one of the methods specified under
The legal basis and authorities for this rule are found in 33 U.S.C. 1231, 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1,
The COTP Mobile proposes to establish a temporary safety zone for a portion of Bayou Grande, Pensacola, FL.
The Coast Guard proposes to establish a temporary safety zone for a portion of Bayou Grande, Pensacola, FL. The proposed safety zone will be enforced for a short period during the sea plane landing and transit occurring on one day between April 21, 2014 and May 4, 2014. Notice of the specific date and times of enforcement will be provided via broadcast notice to mariners and local notice to mariners. The specific date, time, landing path and transit to the Naval Aviation Station has yet to be determined. Specific boundaries for this proposed temporary safety zone will be defined in the Temporary Final Rule to be published in the
The COTP may be contacted by telephone at 251-441-5976. The COTP Mobile or a designated representative will inform the public through Broadcast Notice to Mariners of changes in the effective period for the safety zone. This proposed rule would be effective from April 21, 2014 through May 4, 2014. The proposed safety zone will be enforced for a short period during the sea plane landing and transit occurring on one day between April 21, 2014 and May 4, 2014. Notice of the specific date and times of this proposed safety zone and its enforcement will be provided via broadcast notice to mariner and local notice to mariners.
The COTP anticipates minimal impact on vessel traffic due to this regulation. However, this safety zone is deemed necessary for the protection of life and property within the COTP Mobile zone. The Naval Aviation Museum has an active work group conducting meetings with federal, state, and local agencies and businesses and the Coast Guard does not anticipate any adverse comments or objections to this rulemaking.
We developed this proposed rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes or executive orders.
This proposed rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders.
The safety zone listed in this proposed rule will only restrict vessel traffic from entering, transiting or anchoring in a small portion of Bayou Grande, Pensacola, FL. The effect of this regulation will not be significant for several reasons: (1) this proposed rule will only affect vessel traffic for a short duration; (2) vessels may request permission from the COTP to transit through the safety zone; and (3) the impacts on routine navigation are expected to be minimal. Notifications to the marine community will be made through Local Notice to Mariners and Broadcast Notice to Mariners. These notifications will allow the public to plan operations around the affected area.
The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule will not have a significant economic impact on a substantial number of small entities. This proposed rule will affect the following entities, some of which may be small entities: The owners or operators of vessels intending to transit or anchor in affected portions of Bayou Grande during the landing of the sea plane. This safety zone would not have a significant economic impact on a substantial number of small entities for the following reasons. This safety zone is limited in size, is of short duration and vessel traffic may request permission from the COTP Mobile or a designated representative to enter or transit through the zone.
If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this proposed rule would have a significant economic impact on it, please submit a comment (see
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the proposed rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
This proposed rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this proposed rule under that Order and have determined that it does not have implications for federalism.
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this proposed rule would not result in such an expenditure, we do discuss the effects of this proposed rule elsewhere in this preamble.
This proposed rule would not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
This proposed rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this proposed rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This proposed rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.
This proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
This proposed rule is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.
This proposed rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.
We have analyzed this proposed rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions which do not individually or cumulatively have a significant effect on the human environment. This proposed rule involves safety for the public and is not expected to result in any significant adverse environmental impact as described in NEPA. This rule is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. A preliminary environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 165 as follows:
33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(1) In accordance with the general regulations in § 165.23 of this part, entry into this zone is prohibited unless
authorized by the Captain of the Port Mobile or a designated representative.
(2) Persons or vessels desiring to enter into or passage through the zone must request permission from the Captain of the Port Mobile or a designated representative. They may be contacted on VHF-FM channels 16 or by telephone at 251-441-5976.
(3) If permission is granted, all persons and vessels shall comply with the instructions of the Captain of the Port or designated representative.
(d)
Postal Service.
Proposed rule.
To clarify existing practice, this proposed rule contains a complete revision to the rules of practice before the Judicial Officer in proceedings under section 5 of the Debt Collection Act.
Comments must be received on or before March 20, 2014.
Mail or deliver written comments to the Office of the Judicial Officer, United States Postal Service, 2101 Wilson Boulevard, Suite 600, Arlington, VA 22201-3078. Copies of all written comments will be available for inspection and photocopying between 9 a.m. and 4 p.m., Monday through Friday, at the above address.
Associate Judicial Officer Gary E. Shapiro, (703) 812-1910.
Part 961 of title 39, Code of Federal Regulations, contains the rules of practice in proceedings under section 5 of the Debt Collection Act of 1982, as amended, 5 U.S.C. 5514, in which the Judicial Officer or an assigned Hearing Official provides the final agency adjudication for debt collection assessments by administrative salary offset issued by the Postal Service seeking to collect a debt owed it by an employee. This authority is delegated by the Postmaster General. Although these rules provide a complete replacement for the former rules, the changes are not considered to affect the rights of the parties in a substantive way. Rather, the rules are revised to conform to current practices and to clarify the procedures.
The provisions of 39 CFR part 961 have been amended as follows:
• § 961.1—This section remains unchanged.
• § 961.2—This section has been modified in minor respects to clarify the language.
• § 961.3—This section has been modified in minor respects to clarify the language.
• § 961.4—This section has been amended to explain that the petition filing deadline is subject to waiver in the discretion of the Hearing Official upon a demonstration of good cause, conforming the rule to the judicial practice. Another change reflects current practice allowing the Hearing Official to resolve the petition where the Postal Service has offset money from an employee's salary without having issued the required Notice. A requirement that the employee's petition state whether a hearing is requested, and provide related information has been deleted. Such a determination is made by the Hearing Official at a later time in the proceeding. Language explaining what information should be included in the petition has been modified for accuracy. Language regarding supplementation of the petition has been replaced with a statement that the employee shall supply additional information as directed by the Hearing Official, to reflect current practice. The section also includes minor changes in wording for purposes of clarification.
• § 961.5—This section has been modified in minor respects to clarify the language.
• § 961.6—This section has been modified to require a party filing any document with the Hearing Official to transmit a copy to the other party. Another change establishes standards and timing for time extension requests, and for representatives of parties to file notices of appearance. A further amendment reflects current practice permitting non-attorney representation of employees, to be consistent with the practice of representation for the Postal Service. The section also includes minor wording changes for purposes of clarification.
• § 961.7—This section has been changed to require specific information in the answer and to delete formerly required information in the answer to conform to current practice.
• § 961.8—This section has been modified to reflect more accurately the Hearing Official's authority and responsibilities and to conform them to current practice. Included changes clarify that the Hearing Official determines whether a hearing is conducted and that the Hearing Official may examine witnesses during a hearing. Other minor changes have been made to clarify the language.
• § 961.9—This is a new section which establishes that the Hearing Official determines whether a hearing is to be conducted and the type of hearing that is to be conducted.
• § 961.10—This section (formerly § 961.9) has been modified in minor respects to clarify the language.
• § 961.11—This section (formerly § 961.10) has been changed to conform to existing practice. This includes clarifying that a party that does not comply with the rules in a material way risks a default judgment being entered against it after an order to show cause has been issued. Other changes provide specific authority for the Hearing Official to dismiss a petition where it has been withdrawn, and to grant a petition where the Postal Service files a withdrawal of the debt determination.
• § 961.12—This section (formerly § 961.11) has been modified to be consistent with the definition of an ex parte communication included in the Administrative Procedures Act.
These revised rules will govern proceedings under part 961 docketed on or after 30 days from their publication in final form.
Claims, Government employees, Wages.
For the reasons stated in the preamble, the Postal Service hereby proposes to revise 39 CFR part 961 as set forth below:
39 U.S.C. 204, 401; 5 U.S.C. 5514.
These rules are issued by the Judicial Officer pursuant to authority delegated by the Postmaster General.
The rules in this part apply to the hearing provided by section 5 of the Debt Collection Act of 1982, as amended, 5 U.S.C. 5514, challenging the Postal Service's determination of the existence or amount of an employee debt to the Postal Service, or of the terms of the employee's debt repayment schedule. In addition, these rules apply to a hearing under section 5 of the Debt Collection Act when an Administrative Law Judge or an Administrative Judge in the Judicial Officer Department is designated as the Hearing Official for a creditor Federal agency other than the Postal Service pursuant to an agreement between the Postal Service and that agency. In such cases, all references to Postal Service within these rules shall be construed to refer to the creditor Federal agency involved.
As used in this part:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(a) If an employee desires a hearing, prescribed by section 5 of the Debt Collection Act, to challenge the Postal Service's determination of the existence or amount of a debt, or to challenge the involuntary repayment terms proposed by the Postal Service, the employee must file a written, signed petition with the Recorder, on or before the fifteenth (15th) calendar day following the employee's receipt of the Postal Service's “Notice of Involuntary Administrative Salary Offsets Under the Debt Collection Act.” The Hearing Official, in his or her discretion may waive this deadline upon a demonstration of good cause. In the event that the Postal Service initiated involuntary administrative salary offsets without having issued a Notice as required by the Debt Collection Act, the Hearing Official, in his or her discretion, may retain authority to resolve the debt assessment as if a Notice had been issued, and may order the Postal Service to return any improperly offset money.
(b) The hearing petition shall include the following:
(1) The words, “Petition for Hearing under the Debt Collection Act,” prominently captioned at the top of the first page;
(2) The name of the employee, the employee's work address, home address, work telephone number, home telephone number, and email address, if any, or other address and telephone number at which the employee may be contacted during business hours;
(3) A statement of the date on which the employee received the “Notice of Involuntary Administrative Salary Offsets Under the Debt Collection Act,” and a copy of the Notice;
(4) A statement indicating whether the employee challenges: (i) The existence of the debt identified in the Notice of Involuntary Administrative Salary Offsets; (ii) the amount of the debt identified in the Notice; and/or (iii) the involuntary repayment terms identified by the Postal Service in the Notice. For each challenge, the employee's petition shall indicate the basis of the employee's disagreement. The employee should identify and explain the facts, evidence, and legal arguments which support his or her position;
(5) Copies of all records in the employee's possession which relate to the debt; and
(6) If an employee contends that the Postal Service's proposed offset schedule would result in a severe financial hardship on the employee, his or her spouse, and dependents, the employee shall identify an alternative offset schedule. As directed by the Hearing Official, the employee shall provide a statement and supporting documents indicating the employee's financial status. This statement should address total income from all sources; assets; liabilities; number of dependents; and expenses for food, housing, clothing, transportation, medical care, and exceptional expenses, if any.
(c) The employee shall file with the Recorder, any additional information directed by the Hearing Official.
Upon receipt and docketing of the employee's petition for a hearing, further collection activity by the Postal Service must cease, as required by section 5 of the Debt Collection Act until the petition is resolved by the Hearing Official.
(a)
(b)
(c)
(d)
Within 15 days from the date of receiving the petition, the Postal Service's representative shall file an answer to the petition, and attach all available relevant records and documents in support of the Postal Service's debt claim, and/or the administrative salary offset schedule proposed by the Postal Service for collecting any such claim. The answer shall provide a clear and thorough description of the basis for the Postal Service's determination of the alleged debt, its calculation of the amount of the alleged debt, and/or its proposed offset schedule.
The Hearing Official's authority includes, but is not limited to, the following:
(a) Ruling on all motions or requests by the parties.
(b) Issuing notices, orders or memoranda to the parties concerning the hearing proceedings.
(c) Conducting telephone conferences with the parties to expedite the proceedings. The Hearing Official will prepare a Memorandum of Telephone Conference, which shall be transmitted to both parties and which serves as the official record of that conference.
(d) Determining whether an oral hearing shall be conducted, the type of oral hearing to be held, and setting the place, date, and time for such hearing.
(e) Administering oaths or affirmations to witnesses.
(f) Conducting the hearing in a manner to maintain discipline and decorum while assuring that relevant, reliable and probative evidence is elicited on the issues in dispute, but irrelevant, immaterial or repetitious evidence is excluded. The Hearing Official in his or her discretion may examine witnesses to ensure that a satisfactory record is developed.
(g) Establishing the record in the case. The weight to be attached to any evidence of record will rest within the discretion of the Hearing Official. Except as the Hearing Official may otherwise order, no proof shall be received in evidence after completion of an oral hearing or, in cases submitted on the written record, after notification by the Hearing Official that the record is closed. The Hearing Official may require either party, with appropriate notice to the other party, to submit additional evidence on any relevant matter;
(h) Granting reasonable time extensions or other relief for good cause shown in the Hearing Official's sole discretion.
(i) Issuing the final decision. The decision must include the determination of the amount and validity of the alleged debt and, where applicable, the repayment schedule.
An oral hearing shall be conducted in the sole discretion of the Hearing Official. An oral hearing may be conducted in-person, by telephone, by video conference, or other appropriate means as directed by the Hearing Official. When the Hearing Official determines that an oral hearing shall not be conducted, the decision shall be based solely on the written submissions. The Hearing Official shall arrange for the recording and transcription of an oral hearing, which shall serve as the official record of the hearing. In the event of an unexcused absence, the hearing may proceed without the participation of the absent party.
(a) After the receipt of written submissions or after the conclusion of the hearing and the receipt of post-hearing briefs, if any, the Hearing Official shall issue a written decision, which shall include the findings of fact and conclusions of law, relied upon.
(b) The Hearing Official shall send each party a copy of the decision. The Hearing Official's decision shall be the final administrative determination on the employee's debt or repayment schedule. No reconsideration of the decision will be allowed unless a motion for reconsideration is filed within 10 days from receipt of the decision and shows good cause for reconsideration. Reconsideration will be allowed only in the discretion of the Hearing Official. A motion for reconsideration by the employee will not operate to stay a collection action authorized by the Hearing Official's decision.
(a) The Hearing Official may determine that the employee has abandoned the right to a hearing, and that administrative offset may be initiated if the employee files his or her petition late without good cause; or files a withdrawal of the employee's petition for a hearing.
(b) The Hearing Official may determine that the administrative offset may not be initiated if the Postal Service fails to file the answer or files the answer late without good cause; or files a withdrawal of the debt determination at issue.
(c) If a party fails to comply with these Rules or the Hearing Official's orders, the Hearing Official may take such action as he or she deems reasonable and proper under the circumstances, including dismissing or granting the petition as appropriate.
Ex parte communications are not allowed between a party and the Hearing Official or the Official's staff.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve portions of two revisions to the Texas State Implementation Plan (SIP) submitted by the Texas Commission on Environmental Quality (TCEQ) to EPA on October 5, 2010, and December 2, 2013. Together, these two SIP submittals revise the Texas Prevention of Significant Deterioration (PSD) Program to provide for the regulation of greenhouse gas (GHG) emissions and clarify the applicability of Best Available Control Technology (BACT) for all PSD permit applications. The December 2, 2013, submittal is a request for parallel processing of revisions proposed by the TCEQ on October 23, 2013. The December 2, 2013, submittal includes proposed revisions to the Texas SIP to provide the State of Texas with the express authority to regulate GHG emissions, issue PSD permits governing GHG emissions, establish appropriate emission thresholds for determining which new stationary sources and modifications to existing stationary sources become subject to Texas's PSD permitting requirements for their GHG emissions, and revises several Minor New Source Review (NSR) provisions to specify that Minor NSR permit mechanisms cannot be used for authorizing GHG emissions. The December 2, 2013, SIP revision also defers until July 21, 2014, application of the PSD permitting requirements to biogenic carbon dioxide emissions from bioenergy and other biogenic stationary sources. The October 5, 2010, submittal
Comments must be received on or before March 20, 2014.
Submit your comments, identified by Docket ID No. EPA-R06-OAR-2013-0808 by one of the following methods:
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•
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Ms. Adina Wiley (6PD-R), Air Permits Section, Environmental Protection Agency, Region 6, 1445 Ross Avenue (6PD-R), Suite 1200, Dallas, TX 75202-2733. The telephone number is (214) 665-2115. Ms. Wiley can also be reached via electronic mail at
Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.
The CAA at section 110(a)(2)(C) requires states to develop and submit to EPA for approval into the SIP, preconstruction review and permitting programs applicable to certain new and modified stationary sources of air pollutants for attainment and nonattainment areas that cover both major and minor new sources and modifications, collectively referred to as the NSR SIP. The CAA NSR SIP program is composed of three separate programs: PSD, Nonattainment NSR (NNSR), and Minor NSR. PSD is established in part C of title I of the CAA and applies in areas that meet the National Ambient Air Quality Standards (NAAQS)—“attainment areas”—as well as areas where there is insufficient information to determine if the area meets the NAAQS—“unclassifiable areas.” The NNSR SIP program is established in part D of title I of the CAA and applies in areas that are not in attainment of the NAAQS—“nonattainment areas.” The Minor NSR SIP program addresses construction or modification activities that do not emit, or have the potential to emit, beyond certain major source thresholds and thus do not qualify as “major” and applies regardless of the designation of the area in which a source is located. EPA regulations governing the criteria that states must satisfy for EPA approval of the NSR programs as part of the SIP are contained in 40 CFR sections 51.160—51.166.
Texas submitted on October 5, 2010, and December 2, 2013, a collection of regulations for approval by EPA into the Texas SIP, including some regulations specific to the Texas PSD permitting program to clarify the applicability of BACT for all PSD permit applications and to provide for regulation of GHG emissions through the Texas PSD program. The October 5, 2010, submittal included revisions to the Permit Application requirements for the Texas NSR program at 30 TAC Section 116.111
We have evaluated the SIP submissions for whether they meet the CAA and 40 CFR Part 51, and are consistent with EPA's interpretation of the relevant provisions. Today's proposed action and the accompanying Technical Support Document (TSD) present our rationale for proposing approval of these regulations as meeting the minimum federal requirements for the adoption and implementation of the PSD SIP permitting programs. Note that Texas is currently subject to the PSD Federal Implementation Plan (FIP) at 40 CFR 52.2305. See 76 FR 25178, May 3, 2011. We are also proposing to rescind the PSD FIP for Texas when we finalize today's proposed action. EPA is proposing to sever and take no action on the portions of the October 5, 2010, submittal that pertain to the Texas Minor NSR Qualified Facilities Program. EPA is proposing to sever and take no action on the portions of the December 2, 2013, submittal that relate to the provisions of EPA's Biomass Deferral for the reasons stated above.
This section summarizes EPA's recent GHG-related actions. Please see the preambles for the identified GHG-related rulemakings for more information.
EPA has recently undertaken a series of actions pertaining to the regulation of GHGs that, although for the most part are distinct from one another, establish the overall framework for today's proposed action on the Texas SIP. Four of these actions include, as they are commonly called, the “Endangerment Finding” and “Cause or Contribute Finding,” which EPA issued in a single final action,
All of the states identified in the SIP Call, except for Texas, either (i) submitted a corrective SIP revision to apply their CAA PSD programs to sources of GHG emissions promptly enough to avoid adverse impacts on their new or modifying sources, or (ii) did not object to EPA establishing a deadline for SIP revisions of December 22, 2010. For the latter states, EPA published a finding of failure to submit the required SIP revision by the specified deadline and then immediately promulgated the GHG PSD FIP to ensure the availability of a permitting authority for GHG emitting sources subject to PSD requirements in those states.
The State of Texas did not identify a GHG SIP revision deadline; therefore, EPA assigned a default twelve-month SIP revision deadline of December 1, 2011. This meant that, absent further action, there would be no authority in Texas to issue PSD permits starting January 2, 2011. In that case, GHG-emitting sources seeking to undertake construction or modification activities during almost all of 2011 would have no permitting authority available to issue a PSD permit until, at the earliest, December 2011.
To remedy this situation, EPA determined that pursuant to CAA Section 110(k)(6), its prior approval of Texas's PSD program “was in error” because, among other things the SIP failed to address all pollutants that would become subject to regulation in the future or provide assurance of Texas's legal authority to do so. EPA corrected its previous full approval of Texas's PSD SIP to be a partial approval and partial disapproval. The partial disapproval reflected the PSD SIP's failure to address how PSD would apply to newly regulated pollutants. At the same time, EPA promulgated a FIP that applied PSD to GHGs, which are the newly regulated pollutants presently at issue. That FIP established EPA as the permitting authority, so that as of January 2, 2011, EPA could issue PSD permits to Texas's GHG-emitting
EPA took this action in December 2010, through an interim final rulemaking, without a prior proposal, under the “good cause” exception of 5 U.S.C. Section 553(b)(B), in light of the need to establish a permitting authority by January 2, 2011. EPA further provided that the interim final rulemaking would expire by May 1, 2011. At the same time, EPA proposed to take the same action through notice-and-comment rulemaking. By May 1, 2011, EPA completed the notice-and-comment rulemaking by finalizing a rule that mirrored the interim final rulemaking by correcting the previous full approval of Texas's PSD SIP provision to be a partial approval and partial disapproval, and by promulgating a FIP that established EPA as the permitting authority for GHG-emitting sources.
For other states, EPA recognized that many states had approved SIP PSD programs that do apply PSD to GHGs, but that do so for sources that emit as little as 100 or 250 tpy of GHG, and that do not limit PSD applicability to GHGs to the higher thresholds in the Tailoring Rule. Therefore, EPA issued the GHG PSD SIP Narrowing Rule.
On July 20, 2011, EPA promulgated the final Biomass Deferral Rule. The Biomass Deferral delayed until July 21, 2014, the consideration of CO
On July 12, 2012, EPA promulgated the final “Prevention of Significant Deterioration and Title V Greenhouse Gas Tailoring Rule Step 3 and GHG Plantwide Applicability Limits” (GHG Tailoring Rule Step 3 and GHG PALs). EPA's rationale for the rule is available in the notice of final rulemaking at 77 FR 41051. EPA finalized Step 3 by determining not to lower the current GHG applicability thresholds from the Step 1 and Step 2 levels because state permitting authorities had not had sufficient time and opportunity to develop the necessary infrastructure and increase their GHG permitting expertise and capacity, and the state permitting authorities and EPA had not had the opportunity to develop streamlining measures to improve permit implementation. See 77 FR 41051, 41052. The Tailoring Rule Step 3 also promulgated revisions to our regulations under 40 CFR part 52 for better implementation of the federal program for establishing PALs for GHG emissions. A PAL establishes a site-specific plantwide emission level for a pollutant that allows the source to make changes at the facility without triggering the requirements of the PSD program, provided that emissions do not exceed the PAL level. Under the EPA's interpretation of the federal PAL provisions, such PALs are already available under PSD for non-GHG pollutants and for GHGs on a mass basis, and we revised the PAL regulations to allow for GHG PALs to be established on a CO
The revisions to the PSD PAL rules for GHG permitting are voluntary for a state to adopt and implement. The December 2, 2013, submittal from Texas does not address the Tailoring Rule Step 3 GHG PAL revisions.
In a letter dated October 5, 2010, Mr. Bryan W. Shaw, Ph.D., Chairman of the TCEQ, submitted revisions to the Texas SIP that were adopted on September 15, 2010, and became effective on October 7, 2010. This submittal included the following revisions that were submitted primarily to address the Texas Minor NSR Qualified Facilities Program:
• Substantive and non-substantive revisions to General Definitions for the Texas NSR Program at 30 TAC Section 116.10,
• New definitions at 30 TAC Section 116.17 for the Texas Qualified Facilities Program,
• Substantive and non-substantive revisions to the General Application Provisions for the Texas NSR Program at 30 TAC Section 116.111,
• Substantive revisions to the provisions for Changes to Facilities at 30 TAC Section 116.116 specific to qualified facilities, and
• Substantive and non-substantive revisions to the provisions for Documentation and Notification of Changes to Qualified Facilities at 30 TAC Section 116.117.
EPA's proposed action today will only evaluate the revisions to the General Application requirements at 30 TAC Section 116.111 that are necessary to support the Texas PSD program, including the permitting of GHG emissions in Texas. EPA is severing and taking no action at this time on the remaining components of the October 5, 2010, SIP submittal that address the Qualified Facilities program. By severing, we mean that the October 5, 2010 submittal of the revisions to the General Application requirements at 30 TAC Section 116.111 can be implemented independently of the portions of the submittal relating to the Texas Minor NSR Qualified Facilities program. EPA will evaluate and take action on the remaining portions of the October 5, 2010, SIP submittal at a later date.
In a letter dated December 2, 2013, Mr. Zak Covar, Executive Director of the TCEQ, requested parallel processing of the October 23, 2013, proposed new and amended rules to implement the requirements of Texas House Bill (HB) 788, 83rd Legislature, 2013. Texas HB 788 directed the TCEQ to adopt rules necessary to implement the requirements of EPA's GHG Tailoring Rule and limit the regulation of GHGs only to the Texas PSD program. The December 2, 2013, parallel processing submittal consisted of the following revisions:
• 30 TAC Chapter 39—Public Notice.
The rules governing public notice for applications for air quality permits are
○ 30 TAC Section 39.411—Text of Public Notice.
The TCEQ has proposed revisions to 30 TAC Section 39.411 that will require the public notice for a GHG PSD permit application to include a statement that any person is entitled to request a public meeting or a notice and comment hearing. The TCEQ has also amended this section to include the phrase “as applicable” in reference to the air quality analyses that must be made available for review. Additionally, the TCEQ has proposed several typographical corrections throughout section 39.411.
○ 30 TAC Section 39.412—Combined Notice for Certain Greenhouse Gases Permit Applications.
The TCEQ has proposed this new section to streamline the permit application process
○ 30 TAC Section 39.419—Notice of Application and Preliminary Decision.
The TCEQ has amended this section to add the phrase “as applicable” in reference to the air quality analysis that must be available for public review.
○ 30 TAC Section 39.420—Transmittal of the Executive Director's Response to Comments and Decision.
TCEQ has amended this section to include a new provision at 30 TAC Section 39.420(e)(4) that says public notice documents for GHG PSD permits do not need to include instructions on how to request a contested case hearing or requesting the commission reconsider the Executive Director's decision.
• 30 TAC Chapter 101—General Air Quality Rules.
The TCEQ has amended the definitions and general rules germane to the Texas SIP to implement the requirements of Texas HB 788 and to provide authority to regulate GHGs.
○ 30 TAC Section 101.1—Definitions.
The TCEQ has proposed a new definition for GHGs at 30 TAC Section 101.1(42).
The TCEQ has also proposed several amendments to the definition of Reportable Quantity at 30 TAC Section 101.1(89) to establish that there is no reportable quantity for GHGs (except for the specific individual air contaminants found in the current definition of RQ), and establish a reportable quantity of 5,000 pounds for 3-pentanone, 1,1,1,2,2,4,5,5,5-nonafluoro-4-(trifluromethyl)-, CAS No. 756-13-8 (hereafter referred to as C6 fluoroketone) rather than the default reportable quantity of 100 pounds.
The TCEQ has also proposed amendments to the definition of unauthorized emissions at 30 TAC Section 101.1(108) to exclude emissions of carbon dioxide (CO
The TCEQ has also proposed a number of non-substantive amendments to correct for renumbering and internal referencing to other TAC provisions.
○ 30 TAC Section 101.10—Emissions Inventory Requirements.
The TCEQ has proposed amendments to 30 TAC Section 101.10(a)(3) to provide an exception for GHG emissions to the applicable criteria for which an owner or operator is required to submit emission inventories.
The TCEQ has also proposed non-substantive revisions for renumbering and formatting and to update references to other TAC provisions.
○ 30 TAC Section 101.201—Emissions Event Reporting and Recordkeeping Requirements.
The TCEQ has proposed an amendment to specify that any emissions of GHG, individually or collectively, are not subject to emissions event reporting.
• 30 TAC Chapter 106—Permits by Rule.
The Texas Permits by Rule (PBR) program under 30 TAC Chapter 106, is one component of the SIP-approved Minor NSR program in Texas. The TCEQ has proposed amendments to the Minor NSR PBR program at 30 TAC Section 106.2 to clarify that emissions of GHG cannot be authorized through a PBR. Additionally, the TCEQ has proposed an amendment to 30 TAC Section 106.4 to specify that for sources that are only subject to PSD for GHG emissions, a PBR can still be used to authorize the non-PSD emissions; provided that the source obtains the GHG PSD construction permit prior to commencing construction.
• 30 TAC Chapter 116—Control of Air Pollution by Permits for New Construction or Modification.
The Texas PSD program and necessary implementing definitions are SIP-approved under 30 TAC Chapter 116. With the exception of PBR which are codified at 30 TAC Chapter 106, the remainder of the SIP-approved Texas Minor NSR program is SIP-approved at 30 TAC Chapter 116. The TCEQ has proposed several amendments to this chapter to provide for PSD permitting of GHG emissions and to limit the scope of the Texas Minor NSR programs to not include emissions of GHG. Specifically, the TCEQ has proposed the following:
○ 30 TAC Section 116.12—Nonattainment and Prevention of Significant Deterioration Definitions.
The TCEQ has proposed new definitions for the “CO
The TCEQ has also proposed revisions to the definitions of “Federally Regulated NSR pollutant,” “major stationary source,” and “major modifications.”
The TCEQ has also proposed renumbering to accommodate the proposed new definitions.
○ 30 TAC Section 116.111—General Application.
The TCEQ has proposed an amendment to the general application provisions to require a PSD permit for GHG emissions that meet or exceed the thresholds for GHG PSD permitting established in new proposed section 116.164. This amendment will specify that GHG permitting is statewide, without regard to an attainment designation for GHG permitting.
○ 30 TAC Section 116.160—Prevision of Significant Deterioration Requirements.
TCEQ has proposed an amendment to 30 TAC Section 116.160(a) to require new major sources of GHG emissions or major modifications of GHG emissions to comply with the PSD permitting program regardless of location of the source.
TCEQ has proposed amendments to 30 TAC Section 116.160(b)(2) to include references to the netting requirements for GHG applicability thresholds established in new section 116.164.
TCEQ has also proposed an amendment to 30 TAC Section 116.160(c) to clarify that emissions of
○ 30 TAC Section 116.164—Prevention of Significant Deterioration Applicability for Greenhouse Gases Sources.
The TCEQ has proposed a new subsection to the Texas PSD program specifically for the permitting of GHG emissions. This new subsection establishes the applicability thresholds developed by EPA in the GHG Tailoring Rule.
○ 30 TAC Section 116.169—Greenhouse Gas Transition.
The TCEQ has proposed a new subsection to the Texas PSD program to address the transition process for permit applicants upon the effective date of the rescission of the GHG PSD FIP by the EPA Administrator. The proposed subsection does not identify the actions to be taken by EPA; it only establishes that upon the rescission of the FIP, the TCEQ will accept the transfer and review of pending permit applications. The actions to be taken by EPA during the transition process will be discussed in section IV.B. of this notice.
• 30 TAC Chapter 122—Federal Operating Permits.
The TCEQ proposed several amendments to the Texas Title V program on October 23, 2013; but only the proposed revisions to 30 TAC Section 122.122—Potential to Emit—have been submitted for parallel processing into the Texas SIP. In this proposed revision, the TCEQ amends the potential to emit provisions to clarify that existing sites must certify emissions of GHG below major source thresholds. Existing sites that are currently operating will have 90 days after EPA's FIP rescission to certify emissions of GHGs to avoid applicability of Title V permitting.
• The TCEQ December 2, 2013, commitment letter also addresses the requirement that the state provide the necessary assurances of its authority to address all future federally regulated pollutants under the Texas PSD program, in order to remove the PSD FIP at 40 CFR 52.2305(c).
• The January 13, 2014, letter from TCEQ demonstrates its authority to administer the Texas PSD program for EPA issued GHG PSD permits.
As explained previously in section II.A., EPA's analysis of the October 5, 2010, submittal only addresses the submitted substantive and non-substantive revisions to the General Application provisions to the Texas NSR program at 30 Section TAC 116.111. The substantive revision to 30 TAC Section 116.111(a)(2)(C) clarifies when federal BACT will be applied to PSD permit applications. The TCAA requires the TCEQ to apply BACT to all facilities and to all contaminants emitted from said facilities that are permitted under the TCAA, including non-PSD sources and modifications. EPA refers to this process as “Texas BACT.” We view the application of Texas BACT, which would include BACT for Minor NSR permitting, to be a separate requirement from the application of federal BACT as required in EPA's PSD regulations and the Texas SIP-approved PSD Program. To clarify the requirements of the TCAA and to ensure compliance with federal PSD regulations, the TCEQ has submitted revisions to the general application provisions at 30 TAC Section 116.111(a)(2)(C). Pursuant to the submitted revisions, BACT consistent with the Texas Clean Air Act (Texas BACT) will be applied to all permit applications under the TCAA. However, prior to the application of Texas BACT, if the permit application is for a new source or modification subject to PSD, then BACT consistent with the federal PSD requirements and the SIP-approved Texas PSD program must be applied. The SIP-approved Texas PSD program at 30 TAC Section 116.160(c)(1)(A) incorporates the requirements for BACT at 40 CFR 52.21(b)(12).
As described in the discussion in Section II.B of this proposal notice, the TCEQ proposed revisions to several portions of the Texas Air Code to implement the requirements of Texas HB 788 and to provide TCEQ the authority to regulate GHG emissions through the Texas PSD program. Texas HB 788 required further revisions to the Texas SIP and the Minor NSR program to ensure that GHG emissions would only be regulated via the PSD program as required through EPA's GHG Tailoring Rule. The analysis in this section will be presented based on those revisions necessary for the PSD program and those that are non-PSD.
EPA is parallel processing the revisions proposed on October 23, 2013, based on the request submitted on December 2, 2013. This means that EPA is proposing approval at the same time that Texas is completing the public comment and rulemaking process at the state level. The December 2, 2013, SIP revision request will not be complete and will not meet all the adequacy criteria until the state public process is complete and the SIP revision is submitted as a final adoption with a letter from the Governor or Governor's designee. EPA is proposing to approve the SIP revision request after completion of the state public process and final submittal.
TCEQ has proposed several new definitions in the Texas SIP to adopt and implement the permitting of GHGs consistent with federal requirements.
• TCEQ proposed new definitions at 30 TAC Sections 101.1(42) and 116.12(16) to adopt the definition of “greenhouse gases”. Based on our analysis, EPA proposes to find that the new definitions of GHG are consistent with the federal PSD definition at 40 CFR 51.166(b)(48).
• The TCEQ has also proposed a new definition for “carbon dioxide equivalent (CO
• The TCEQ also proposed revisions to the definition of “potential to emit” at 30 TAC Section 122.122. EPA proposes to find that these revisions are necessary to update the SIP-approved definition to account for the permitting of GHG emissions. The Texas PSD program relies on a source's potential to emit for establishing applicability of the PSD rules.
EPA's analysis is that the new definitions for GHG and CO
The December 2, 2013, proposed revisions included revisions to the Texas Public Notice requirements for PSD permitting at 30 TAC Chapter 39. On January 6, 2014, EPA approved the Texas public notice rules for PSD permitting for inclusion in the Texas SIP. See 79 FR 551. Our final approval found that the Texas public notice process of the Notice of Receipt of Application and Intent to Obtain Permit (NORI) and the Notice of Application and Preliminary Decision (NAPD) would satisfy all PSD-specific public notice requirements at 40 CFR 51.160, 51.161 and 51.166(q). We note that Texas regulations require that non-GHG PSD permits are subject to the Texas Contested Case Hearing (CCH) process which EPA has determined is outside the scope of the Texas SIP. Texas HB 788 specifically directed the TCEQ to adopt and implement regulations to issue GHG PSD permits; however these GHG PSD permits will be exempted from the Texas CCH process. This exemption required the TCEQ to revise the PSD public notice provisions at 30 TAC Chapter 39 to address the special requirements for issuing separate GHG PSD permits. Additionally, the PSD public notice provisions were revised to accommodate the subset of pending permit applications that will be transferred to TCEQ from EPA upon the effective date of the GHG PSD FIP rescission. Because of these revisions to the PSD public notice rules, EPA finds it necessary to evaluate the Texas proposed revisions to 30 TAC Chapter 39 with respect to the federal PSD requirements at 40 CFR 51.166(q) to ensure all federal requirements continue to be satisfied in the December 2, 2013, proposed SIP revision.
Proposed 30 TAC Section 116.111(a)(2)(I)(ii) requires that a proposed facility or modification that meets or exceeds the GHG emission thresholds defined in new 30 TAC Section 116.164 must comply with all applicable requirements in 30 TAC Chapter 116 for PSD permitting. One such applicable requirement for PSD permitting is the SIP-approved requirement at 30 TAC Section 116.111(b)(2) which requires that Chapter 39 public notice provisions are followed for PSD permits declared administratively complete on or after September 1, 1999. Therefore, proposed 30 TAC Section 116.111(a)(2)(I)(ii) and the existing SIP establish that the requirements found in 30 TAC Chapter 39, Subchapters H and K apply to applications for the new major source or major modifications for facilities subject to Chapter 116, Subchapter B, Division 6, Sections 116.164 and 116.169 for GHG PSD Permitting. Every application for a new major source or major modification subject to GHG PSD permitting requirements will therefore go through public notice with both the NORI and NAPD. Note that under the SIP, as of January 6, 2014, the applicant, rather than the state permitting authority, is the legally responsible party for satisfying the public notice requirements for PSD applications. For example, the applicant continues to be legally responsible for the publication of the NORI and NAPD, using the specific notice text provided through regulations by the TCEQ. The applicant is also legally responsible for providing copies of the public notice documents to the EPA Regional Office, local air pollution control agencies with jurisdiction in the county, and air pollution control agencies of nearby states that may be impacted by the proposed new source or modification. The applicant is required to follow the Texas public notice regulations, which specify the text for the notice documents and specify the additional agencies that will receive notice.
The TCEQ has proposed revisions to the public notice text requirements at 30 TAC Section 39.411 specific to GHG PSD permit applications at Sections 39.411(e)(11), (e)(15), (e)(16), (f)(4) and (f)(8). These proposed revisions to the notice text require that, in addition to the text SIP-approved for PSD permits, the text of the public notice specifically for a GHG PSD permit must specify that any person is entitled to a public meeting or a notice and comment hearing from the commission and that the air quality analysis will be provided if applicable. Currently EPA does not require an air quality analysis for GHG PSD permits. In the event that an analysis is required in the future, the proposed revisions to the Texas Public Notice requirements will include the analysis as required without further rulemaking on the part of TCEQ. Similarly, the TCEQ has proposed revisions to the NAPD text requirements specific to GHG PSD Permit applications at 30 TAC Section 30.419(e)(1) to state that an air quality analysis will be available for public notice as applicable. The proposed revisions to 30 TAC Section 39.420(e)(4) exempt applications for GHG PSD permits from the Texas CCH process. EPA is proposing to find that the GHG PSD specific revisions as discussed above continue to meet the requirements to provide opportunity for public comment and for information availability at 40 CFR 51.161 and 51.166. The NORI and NAPD both identify locations where materials, including the draft permit and all technical materials supporting the decision, will be made available for public review. The TCEQ will also respond to each comment received when making a final permit decision. The TCEQ will provide opportunity for a public meeting on the permit application if requested. TCEQ has exempted the GHG PSD permit applications from the Texas-specific process of contested case hearings, which is outside the scope of the Texas SIP.
The TCEQ has also proposed a new public notice process for the subset of GHG PSD permit applications that are transferred to TCEQ from the EPA upon the effective date of the GHG PSD FIP Rescission and where EPA has already proposed a draft permit. Proposed new Section 30 TAC 39.412 creates an optional Combined Notice process, to be used in lieu of the current SIP-approved process of a separate NORI and NAPD, to streamline the processing of these pending permit applications. Proposed new 30 TAC Section 39.412(a) establishes the applicability of this new section specifically to the subset of applications that were previously filed with EPA and which EPA proposed a draft permit prior to transfer to the TCEQ. Proposed new 30 TAC Section 39.412(b) provides the streamlined
EPA's analysis of the Texas public participation requirements, both for newly submitted GHG PSD permit applications and those transferred from EPA, demonstrates that the submitted provisions are consistent with the Act and EPA regulations at 40 CFR 51.160, 51.161 and 51.166(q). Therefore, we propose approval of the new and revised sections in 30 TAC Chapter 39, submitted for parallel processing on December 2, 2013.
TCEQ has proposed several new provisions in the Texas NSR Program to adopt and implement the permitting of GHG emissions consistent with federal requirements in EPA's GHG Tailoring Rule. The proposed regulations are substantively similar to the federal requirements for the permitting of GHG-emitting sources subject to PSD. The detailed analysis in our TSD demonstrates that the regulatory revisions proposed on October 23, 2013, and submitted for parallel processing on December 2, 2013, establish that Texas has the authority to issue PSD permits for GHG-emitting sources subject to PSD consistent with the federal PSD requirements of EPA's final GHG Tailoring Rule. The revisions also establish thresholds for determining which stationary sources and modification projects become subject to permitting requirements for GHG emissions under its PSD program. Specifically, the December 2, 2013, submittal satisfies the Tailoring Rule requirements in the following ways:
• TCEQ proposed a new provision in the NSR Permit Application procedures at new subsection 30 TAC Section 116.111(a)(2)(I)(ii) that explicitly requires that any proposed facility or modification that meets or exceeds the GHG thresholds established in new proposed section 30 TAC Section 116.164 must comply with all applicable requirements of Chapter 116 for PSD review. This new provision ensures that all PSD requirements such as BACT and public notice will be followed for GHG PSD permit applications. The October 5, 2010, revisions to 30 TAC Section 116.111(a)(2)(C), previously discussed in this proposed rulemaking, complement the implementation of the Texas PSD program, especially with regard to the PSD permitting of GHG emissions. While the October 5, 2010, revisions are germane to the Texas PSD program and ensure that federal BACT consistent with EPA's PSD regulations will apply to all PSD permit applications, we specifically note that the provision also applies to GHG PSD permits and ensures that federal BACT will be applied to all GHG PSD permit applications. EPA proposes to find that the October 5, 2010, revisions to 30 TAC Section 116.111(a)(2)(C) and the proposed new provision at 30 TAC Section 116.111(a)(2)(I)(ii) are necessary to implement the Texas GHG PSD permitting process.
• TCEQ proposed revisions to the Texas PSD program rules at 30 TAC Section 116.160(a) to explicitly require any new major source of GHG emissions or major modification involving GHG emissions shall comply with the applicable requirements of the Texas PSD program. TCEQ proposed further revisions to the Texas PSD program at 30 TAC Sections 116.160(b) and (c) to specify that the proposed new GHG emission thresholds established at 30 TAC Section 116.164 must be used when evaluating a proposed new source or modification for PSD applicability. EPA proposes to find that the proposed revisions to the Texas PSD program at 30 TAC Sections 116.160(a), (b), and (c) are necessary to implement the Texas GHG PSD permitting process.
• TCEQ proposed new 30 TAC Sections 116.164 to establish the PSD applicability requirements for GHG sources.
○ EPA proposes to find that proposed new 30 TAC Section 116.164(a), which establishes the applicability statement for the GHG PSD permitting thresholds, is consistent with the federal requirement at 40 CFR 51.166(b)(48)(iv) to regulate GHG emissions through the PSD program.
○ EPA proposes to find that proposed new 30 TAC Section 116.164(a)(1) is consistent with the federal requirements at 40 CFR 51.166(b)(48)(iv)(a) for the regulation of a new major stationary source that is subject to PSD requirements for a non-GHG pollutant and will emit or have the potential to emit GHG emissions above the specified thresholds.
○ EPA proposes to find that proposed new 30 TAC Section 116.164(a)(2) is consistent with the federal requirements at 40 CFR 51.166(b)(48)(iv)(b) for the regulation of an existing major stationary source that is major for non-GHG and will emit or have the potential to emit GHG emissions above the specified thresholds.
○ EPA proposes to find that proposed new 30 TAC Section 116.164(a)(3) is consistent with the federal requirement at 40 CFR 51.166(b)(48)(v)(a) for the regulation of a new major stationary source that is subject to PSD only for GHG emissions based on the specified thresholds.
○ EPA proposes to find that proposed new 30 TAC Section 116.164(a)(4) is consistent with the federal requirements at 40 CFR 51.166(b)(48)(v)(b) for the regulation of an existing stationary source that is major for GHG emissions and proposes a major modification for GHG emissions above the specified thresholds.
○ EPA proposes to find that proposed new 30 TAC Section 116.164(a)(5) is consistent with the requirement at 40 CFR 51.166(b)(1)(i)(C) for the regulation of an existing minor stationary source for non-GHG pollutants that would undertake a physical change or change in the method of operation that will cause the source to be a major stationary source by itself for GHG emissions at the specified thresholds.
○ Proposed new 30 TAC Section 116.164(b) establishes that new stationary sources or existing stationary sources that make modifications involving emissions of GHG below the thresholds established in new 30 TAC Section 116.164(a) are not required to have an authorization for the GHG emissions through a PSD permit or other Texas Minor NSR permit authorizations
• TCEQ proposed new 30 TAC Section 116.169 to establish the authority for the TCEQ to accept the transfer of permit applications and associated materials upon the effective date of the GHG PSD FIP rescission. EPA proposes to find that new 30 TAC Section 116.169 is necessary for establishing the legal authority for TCEQ to implement the GHG PSD permitting program.
The December 2, 2013, submittal included several proposed revisions to the remainder of the Texas SIP and the Texas Minor NSR programs to satisfy the requirements of Texas HB 788 and restrict the permitting of GHG emissions only to the extent required under federal law. As such, the TCEQ proposed revisions to the definitions of “reportable quantity” at 30 TAC Section 101.1(89) to establish there is no reportable quantity for GHG emissions. TCEQ also proposed revisions to the Emission Inventory Requirements at 30 TAC Section 101.10 to specify that emissions of GHG are not subject to the reporting requirements in the Emission Inventory. Similarly, the TCEQ proposed revisions to the Emissions Event Reporting and Recordkeeping Requirements to specify that emissions of GHG are not included in emissions event reporting. EPA proposes to find that these provisions are consistent with EPA's GHG Tailoring Rule and our determination that emissions of GHG are only subject to regulation in the PSD program above the specified GHG thresholds. There are no federal requirements establishing reportable quantities or reporting requirements for emission inventories or emission events for GHG emissions.
The December 2, 2013, submittal also proposed revisions to the Texas Minor NSR program at 30 TAC Sections 106.2, 106.4, 116.610, and 116.611. The proposed revisions to the Texas Minor NSR Permits by Rule (PBR) Program at 30 TAC Sections 106.2 and 106.4 clarify that a PBR cannot be used to authorize emissions of GHGs. Similarly, the proposed revisions to the Texas Minor NSR Standard Permit Program at 30 TAC Sections 116.610 and 116.611 clarify that a Standard Permit cannot be used to authorize emissions of GHGs. The Texas provisions also provide that if a source is subject to PSD requirements only for the emissions of GHGs, then a PBR or Standard Permit can be used to authorize the non-GHG pollutants. EPA proposes that the revisions to the PBR and Standard Permit are consistent with EPA's Tailoring Rule to only regulate GHG emissions through the PSD program at or above the specified GHG PSD thresholds; therefore, these proposed revisions will ensure that GHG PSD requirements will not be circumvented.
EPA established the final Texas GHG PSD FIP on May 3, 2011, at 40 CFR 52.2305(a), (b), and (c). These provisions remain in effect until EPA approves the state's rules to address the permitting of GHG emissions consistent with federal requirements and EPA rescinds the FIP. The analysis presented in Section III of this rulemaking and the accompanying TSD demonstrate that the October 23, 2013, proposed rules submitted for parallel processing on December 2, 2013, adequately address all federal requirements for GHG PSD permitting. In addition, Mr. Zak Covar, former Executive Director of the TCEQ, submitted a commitment letter on December 2, 2013, that addresses the requirement that the state provide necessary assurances of its authority to address all future regulated pollutants under the Texas PSD program in order to remove the PSD FIP at 40 CFR 52.2305(c). Based on the commitments in the December 2, 2013, letter and the October 23, 2013, proposed rulemaking for permitting emissions of GHG through the Texas PSD program, EPA proposes to find that the TCEQ has the authority under the Texas Clean Air Act to apply the Texas PSD program to all pollutants newly subject to regulation, including non-NAAQS pollutants into the future. EPA recognizes that the TCEQ may be required to proceed through a notice and comment rule development process, but this process in no way prevents the TCEQ from addressing the PSD requirements of the CAA. As such, we are proposing rescission of the Texas GHG PSD FIP at 40 CFR 52.2305(a), (b), and (c), with three limited possibilities for retained authority as detailed below in Section IV.B.
As explained throughout this notice, EPA is proposing approval of the December 2, 2013, submittal as consistent with the requirements for PSD permitting of GHG emissions under EPA's GHG Tailoring Rule. Our analysis demonstrates the TCEQ has proposed necessary rule revisions to provide adequate authority to regulate GHG emissions using appropriate emission thresholds under the Texas PSD program. As such, EPA is simultaneously proposing to rescind the GHG PSD FIP and intends to finalize both actions simultaneously. We expect that the FIP rescission will be effective 30 days after publication of the final approval of the Texas GHG PSD revisions. EPA has developed a process for transitioning pending permit applications and EPA issued permits to the TCEQ following the rescission of the FIP. Our transition process, titled “Transition Process for Pending GHG PSD Permit Applications and Issued GHG PSD Permits Upon Rescission of the GHG PSD FIP” is available in the docket for this rulemaking and on the EPA Region 6 GHG Web site at
EPA's transition process addresses two components of the GHG PSD program—pending permit applications and issued permits.
1. EPA will retain GHG PSD permitting authority for any applicants who select to remain with EPA for GHG PSD permit issuance. This option will be detailed in a letter to the permit applicant and will contain a deadline by which the applicant must inform EPA of its decision to remain with EPA. EPA will also maintain a list of all pending permit applications retained under EPA's GHG PSD permitting authority on the EPA Region 6 GHG Web site, which will be referenced in any future final GHG PSD SIP approval and FIP rescission action EPA may take for Texas.
2. EPA will retain the GHG PSD permitting authority for applicants with pending permits who fail to select a permitting authority by the deadline specified in the above referenced EPA letter to each permit applicant.
3. EPA will retain GHG PSD permitting authority for issued permits for which either (a) the time for filing an administrative appeal has not expired or (b) all administrative and judicial appeal processes (including any associated remand action) have not been completed upon the signature date of any future EPA final action to approve TCEQ's SIP submittal and rescind the GHG PSD FIP. In a letter dated January 13, 2014, TCEQ requested approval to exercise its authority to administer the PSD program with respect to those sources that have final GHG PSD permits issued by EPA upon the effective date of the GHG PSD FIP rescission. This letter is available for review in the docket for this rulemaking. With respect to this transition process, a “final GHG PSD permit issued by EPA” is a permit where all final EPA actions have been taken and all administrative and judicial appeal opportunities have expired or processes have been concluded or completed.
We note that as with any PSD permit application, an applicant may withdraw a pending application for any reason before the permit is issued. With respect to the permit applications for which EPA will retain permitting authority as specified in the transition process, EPA's permitting authority will cease upon an applicant's written request withdrawing the pending permit application before a final determination is made.
For the permit applicants who elect to transfer to TCEQ for GHG PSD permit issuance, EPA will transfer the application, all related technical materials submitted by the applicant, the proposed draft permit and any comments received on the proposed draft permit to TCEQ. The TCEQ will require the applicant to comply with SIP-approved public notice rules. The applicant will either follow the current SIP-approved process of publishing a separate NORI and NAPD, or publish a combined NORI and NAPD notice pursuant to new proposed revisions at 30 TAC Section 39.412. Further, pursuant to the Texas SIP, any comments submitted to EPA on the proposed draft permit must be resubmitted to the TCEQ during the TCEQ's public comment period. EPA intends to identify on the EPA Region 6 GHG Web site which applications with proposed draft permits have been transferred to TCEQ for issuance. EPA will endeavor to notify each commenter about the need to resubmit comments under the SIP-approved Texas public comment period provisions or the newly proposed revisions at 30 TAC Section 39.412.
The TCEQ will assume full PSD responsibility for the administration and implementation of final GHG PSD permits issued by EPA upon notification from EPA that all administrative and judicial appeal processes have expired or have been completed or concluded (including any associated remand actions) for a specific permit or permit application. Assuming full PSD responsibility includes the authority to conduct general administration of these existing permits, authority to process and issue any and all subsequent PSD permit actions relating to such permits (e.g., amendments), and authority to enforce such permits. In the above referenced January 13, 2014, letter, the TCEQ explains that the provisions contained in element 1 of the Texas PSD Supplement (as adopted by the Texas Air Control Board on July 17, 1987) provide the TCEQ the authority to enforce all conditions of PSD permits issued for sources in Texas by EPA prior to full delegation of authority to implement the Texas PSD program. The TCEQ has affirmed that this provision continues to apply to the GHG PSD permits issued by EPA. Therefore, TCEQ has demonstrated it has the authority to administer EPA-issued GHG PSD permits.
EPA has made the preliminary determination that the October 5, 2010, revisions to the Texas SIP that are part of this rulemaking are approvable because they are adopted and submitted in accordance with the CAA and EPA regulations regarding NSR permitting. EPA has made the preliminary determination that the December 2, 2013, proposed revisions to the Texas SIP and request for parallel processing are in accordance with the CAA and EPA regulations regarding SIP development and GHG regulations. EPA invites the public to make comments on all aspects of the EPA proposed approval of the revisions to the Texas NSR SIP to provide for the regulation of GHG emissions and clarify the applicability of BACT for all PSD permit applications, and to submit comments by the date listed above. Therefore, under section 110 and part C of the Act, and for the reasons stated above, EPA proposes to approve the following revisions to the Texas SIP:
• Substantive and non-substantive revisions to 30 TAC Section 116.111 adopted on September 15, 2010, and submitted on October 5, 2010, to clarify the application of BACT to all PSD permit applications in the Texas NSR program;
• Substantive and non-substantive revisions proposed October 23, 2013, and submitted for parallel processing on December 2, 2013, necessary to provide the TCEQ the authority to regulate GHG emissions under the Texas PSD Program:
○ Revisions to Public Notice requirements at 30 TAC Sections 39.411(e)(11), (e)(15), (e)(16), (f)(4), (f)(8), 39.412(a)—(d), 39.419(e)(1), and 39.420(e)(4).
○ Revisions to the entirety of the General Air Quality Definitions at 30 TAC Sections 101.1.
○ Revisions to the Emission Inventory Requirements at 30 TAC Section 101.10.
○ Revisions to Emissions Event Reporting and Recordkeeping Requirements at 30 TAC Section 101.201.
○ Revisions to the Permits by Rule Minor NSR program at 30 TAC Sections 106.2 and 106.4.
○ Revisions to the Definitions for Texas NSR Permitting at 30 TAC Section 116.12.
○ Revisions to Permit Application provisions for Texas NSR Permitting at 30 TAC Section 116.111.
○ Revisions to the Texas PSD Program at 30 TAC Section 116.160.
○ Proposed new 30 TAC Section 116.164 to tailor the PSD thresholds for GHG permitting.
○ Proposed new 30 TAC Section 116.169 to establish the transition process for GHG permitting.
○ Revisions to the Standard Permit Minor NSR program at 30 TAC Sections 116.610 and 116.611.
○ Revisions to the definition of Potential to Emit at 30 TAC Section 122.122.
Texas is subject to the FIP for PSD permitting of GHG emissions. This GHG PSD FIP remains in place and EPA remains the PSD permitting authority for GHG-emitting sources in Texas until EPA finalizes our proposed approval of the October 23, 2013, proposed revisions submitted for parallel processing on December 2, 2013, to the Texas SIP. Therefore, we propose that upon finalization of today's action, EPA will rescind the GHG PSD FIP for Texas at 40 CFR 52.2305(a) and (b). However, as detailed in Sections IV.B.1-3 and our transition process, there are three limited possibilities for retained authority. First, EPA will retain GHG PSD permitting authority for any pending permit applications where the permit applicant has submitted a written request to remain with EPA for permit issuance. Second, EPA will retain GHG PSD permitting authority for any pending permit application where the applicant has not submitted a written request regarding permit authority, and EPA has made a proposed determination through a public noticed draft permit upon the signature date of EPA's rescission of the GHG PSD FIP. EPA does not intend to retain any other authority over pending permit applications. Note, even for those cases where EPA announces it will retain permitting authority over an application, this authority will cease upon an applicant's written request to EPA withdrawing the pending permit application before a final determination is made. Finally, EPA will retain GHG PSD permitting authority for any issued permit for which either the time for filing an administrative appeal has not expired or all administrative and judicial appeals processes have not been completed by the signature date of EPA's final action to approve TCEQ's SIP submittal. Texas is also subject to the FIP for PSD permitting for any other pollutants that become newly subject to regulation under the CAA after January 2, 2011. We propose to find that the TCEQ has provided necessary and adequate assurances that the Texas PSD program will be revised in the future to address pollutants that become newly regulated under the CAA after January 2, 2011, and that the TCEQ has the adequate authority under State law to regulate the new PSD pollutants. Therefore, we propose that upon finalization of today's action, EPA will rescind the PSD FIP for Newly Regulated Pollutants for Texas at 40 CFR 52.2305(c).
EPA is severing and taking no action on the remainder of the October 5, 2010, SIP submittal for the adoption and implementation of the Texas Minor NSR Qualified Facilities Program. EPA is also severing and taking no action on the portions of the December 2, 2013, submittal concerning biomass GHG emissions at 30 TAC Section 116.12(7)(B). The DC Circuit Court issued an order to vacate EPA's Biomass Deferral Rule on July 12, 2013.
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Clean Air Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely proposes to approve state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Reporting and recordkeeping requirements, and incorporation by reference.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve revisions to the New Mexico State Implementation Plan (SIP) at New Mexico Administrative Code 20.11.3 and 20.11.4, concerning transportation conformity and general conformity rules for Bernalillo County, New Mexico. The plan revision is intended to ensure consistency with amendments to the federal Transportation Conformity Rule and the federal General Conformity Rule. These plan revisions meet statutory and regulatory requirements, and are consistent with EPA's guidance.
Written comments should be received on or before March 20, 2014.
Please see the related direct final rule, which is located in the “Rules and Regulations” section of this
Michelle Peace, Facility Assessment Section (6PD-A), Environmental
This document proposes to take action on SIP revisions submitted by the Governor of New Mexico on behalf of the Albuquerque Bernalillo County Air Quality, Environmental Health Department on November 18, 2010, May 24, 2011, and October 11, 2012. We have published a direct final rule approving the State's SIP revisions in the “Rules and Regulations” section of this
If we receive no adverse comment, we will not take further action on this proposed rule. If we receive adverse comment, we will withdraw the direct final rule and it will not take effect. We would address all public comments in any subsequent final rule based upon this proposed rule.
We do not intend to institute a second comment period on this action. Any parties interested in commenting must do so at this time. For further information, please see the information provided in the
Environmental Protection Agency (EPA).
Proposed rule.
On June 8, 2012, the State of Wisconsin, through the Wisconsin Department of Natural Resources (WDNR) submitted a request for the Environmental Protection Agency (EPA) to redesignate the Milwaukee-Racine fine particle (PM
Comments must be received on or before March 20, 2014.
Submit your comments, identified by Docket ID No. EPA-R05-OAR-2012-0464, by one of the following methods:
1.
2.
3.
4.
5.
Gilberto Alvarez, Environmental Scientist, Attainment Planning and Maintenance Section, Air Programs Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312) 886-6143,
Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This
When submitting comments, remember to:
1. Identify the rulemaking by docket number and other identifying information (subject heading,
2. Follow directions—EPA may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
3. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
4. Describe any assumptions and provide any technical information and/or data that you used.
5. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
6. Provide specific examples to illustrate your concerns, and suggest alternatives.
7. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
8. Make sure to submit your comments by the comment period deadline identified.
Fine particulate pollution can be emitted directly from a source (direct PM
The first air quality standards for PM
On October 17, 2006, at 71 FR 61144, EPA retained the annual PM
On November 13, 2009, at 74 FR 58688, EPA published air quality area designations for the 2006 24-hour PM
In response to legal challenges of the 2006 annual PM
On April 24, 2012, and December 28, 2012, EPA proposed and reproposed, respectively, to determine that the Area was in attainment for the 2006 24-hour PM
On June 8, 2012, the Wisconsin Department of Natural Resources (WDNR), submitted a request for EPA to redesignate the Milwaukee-Racine Area to attainment for the 2006 24-hour PM
On May 30, 2013, WDNR submitted ammonia and VOC emissions inventories to supplement previously submitted emissions inventories.
In this proposed redesignation, EPA takes into account two decisions of the D.C. Circuit. In the first of the two Court decisions, the D.C. Circuit, on August 21, 2012, in
The CAA sets forth the requirements for redesignating a nonattainment area to attainment. Specifically, section 107(d)(3)(E) of the CAA allows for redesignation provided that: (1) The Administrator determines that the area has attained the applicable NAAQS based on current air quality data; (2) the Administrator has fully approved an applicable SIP for the area under section 110(k) of the CAA; (3) the Administrator determines that the improvement in air quality is due to permanent and
As noted above, on April 24, 2012, at 77 FR 24436, EPA proposed to determine that the Milwaukee-Racine Area attained the 2006 24-hour PM
In this action EPA is proposing to redesignate the Milwaukee-Racine Area as having attained the 2006 24-hour PM
The state's redesignation request for the Milwaukee-Racine area includes monitoring data for the 2008-2010 time period. In addition, certified monitoring data are also now available for the 2009-2011, 2010-2012 and 2013 time periods. In addition, on January 23, 2013, WDNR submitted draft 2013 data for the area. Table 1, below, provides a summary of the PM
The data in Tables 1 and 2 show that all relevant PM
Aside from Virginia and Wells monitors, EPA notes that the design value for the College Avenue monitor in table 2 is based on incomplete data. However, this is not the design value monitor (i.e., it is not the monitor that had the highest value at the time of designation) for the area and a comparison of the values from the remaining monitors within the nonattainment area indicate that those values are reflective of values that one would expect at College Avenue, which are all below the 2006 24-hour PM
On April 24, 2012, and December 28, 2012, EPA proposed and reproposed, respectively, to determine that the area was in attainment (77 FR 24436 and 77 FR 76427), based on certified ambient monitoring data for the 2008-2010 monitoring period. EPA is here updating and elaborating upon that proposal. We received comments and we are updating the information, based on those comments, within this proposed redesignation.
EPA received two comments from one commenter, Midwest Environmental Defense Center, on our April 24, 2012, proposed rule. The first comment objected to the EPA's use of a statistical analysis to impute a design value for the Wells Street monitor (Site Number 550790099), which did not record data during 2010 and 2011, and which had previously recorded data showing nonattainment. The commenter contended that EPA erred in substituting a design value for this monitor and that EPA's analysis does not establish a direct correlation between the shut down monitors and a nearby operating monitor. On December 14, 2011, EPA requested the restart of the Wells Street monitor (Site Number 55079099). The monitor restarted operation on January 1, 2012, and it has been recording data since that time. The state was diligent in restarting the monitor in consultation with EPA. Data available to date for this monitor site through 2013 are consistent with continued attainment. Data for all four quarters of 2012 is complete and 2013 data has 3 complete quarters.
EPA relied on the data imputation technique because two of the monitors were shut down (Site Numbers 550790043 and 550790099) and did not record data during 2010. As discussed in the proposal, EPA relied on this statistical analysis technique because * * * “In situations like those in Milwaukee, where there are missing or incomplete data due to monitor shutdown or other factors, EPA believes that it is often appropriate to use historical data along with statistical techniques to impute missing data, use those imputed data to estimate the three-year design value that would likely have occurred if complete data had been obtained, and thereby determine if the monitor in question would likely have met the NAAQS.” (77 FR 24436)
The commenter stated that we incorrectly implied “. . . that the compared monitors recorded similar data, when in truth, there is not a direct correlation between the data.” EPA disagrees that there is not enough correlation between the shut down monitor site and the comparison monitor site. In fact, all four monitoring sites in the nonattainment area correlate very well with the replaced monitor. Wisconsin has provided EPA with an analysis comparing the correlations between the shut down monitor to the other four monitors within the nonattainment area, using data from January 1, 2012, through April 9, 2012, when all monitors collected data. The correlations from that analysis are summarized in Table 3.
EPA understands that the publicly available data we relied upon for our imputation is technically listed as “invalid”, due to the shutdown of several monitors, resulting in incomplete data. However, section 4.2(b) provides that “The use of less than complete data is subject to the approval of EPA which may consider factors such as monitoring site closures/moves, monitoring diligence, and nearby concentrations in determining whether to use such data for comparisons to the NAAQS.
Therefore, based upon our statistical analysis, for the purposes of this redesignation, we believe all the monitors are meeting the 2006 24-hour PM
Moreover, in order to account for the uncertainty inherent within the analysis, EPA used another statistical technique to account for the variability in the data from the original site as well as the data from the correlated comparison monitors. The statistical analysis, known as “bootstrapping” was developed by the Office of Air Quality Planning and Standards to aid in predicting annual PM
The results of that analysis provided EPA with further evidence to support a final determination of attainment of the 24-hour PM
EPA's use of these data analysis techniques to address incomplete data in making attainment determinations for the PM
Therefore, pursuant to 50 CFR Appendix N, section 4.2(b), EPA is expressly approving the use of less than complete data after considering relevant factors. These include site closures and moves, monitoring diligence, nearby concentrations and monitor correlations, as well as additional complete data acquired in 2012 and 2013 that show continued attainment in the area.
We have determined that Wisconsin's SIP meets all applicable SIP requirements for purposes of redesignation for the Milwaukee-Racine Area under section 110 of the CAA (general SIP requirements) and all SIP requirements currently applicable for purposes of redesignation under part D of title I of the CAA, in accordance with section 107(d)(3)(E)(v). In addition, with the exception of the emissions inventory under section 172(c)(3), we have approved all applicable requirements of the Wisconsin SIP for purposes of redesignation, in accordance with section 107(d)(3)(E)(ii). As discussed below, in this action EPA is proposing to approve Wisconsin's 2006 and 2010 emissions inventories as meeting the section 172(c)(3) comprehensive emissions inventory requirement.
In making these determinations, we have ascertained which SIP requirements are applicable to the area for purposes of redesignation, and have determined that there are SIP measures meeting those requirements and that they are fully approved under section 110(k) of the CAA.
Section 110(a) of title I of the CAA contains the general requirements for a SIP. Section 110(a)(2) provides that the implementation plan submitted by a state must have been adopted by the state after reasonable public notice and hearing, and, among other things, must: (1) Include enforceable emission limitations and other control measures, means or techniques necessary to meet the requirements of the CAA; (2) provide for establishment and operation of appropriate devices, methods, systems, and procedures necessary to monitor ambient air quality; (3) provide for implementation of a source permit program to regulate the modification and construction of any stationary source within the areas covered by the plan; (4) include provisions for the implementation of part C, Prevention of Significant Deterioration (PSD) and part D, New Source Review (NSR) permit programs; (5) include criteria for stationary source emission control measures, monitoring, and reporting; (6) include provisions for air quality modeling; and (7) provide for public and local agency participation in planning and emission control rule development.
Section 110(a)(2)(D) of the CAA requires that SIPs contain measures to prevent sources in a state from significantly contributing to air quality problems in another state. EPA holds that the requirements linked with a particular nonattainment area's designation are the relevant measures to evaluate in reviewing a redesignation request. The transport SIP submittal requirements, where applicable, continue to apply to a state regardless of the designation of any one particular area in the state. Thus, we conclude that these requirements should not be construed to be applicable requirements for purposes of redesignation.
Further, the other section 110 elements described above that are not connected with nonattainment plan submissions and not linked with an area's attainment status are also not applicable requirements for purposes of redesignation. A state remains subject to these requirements after an area is redesignated to attainment. Only the section 110 and part D requirements that are linked with a particular area's designation are the relevant measures that we may consider in evaluating a redesignation request. This approach is consistent with EPA's existing policy on applicability of conformity and oxygenated fuels requirements for redesignation purposes, as well as with section 184 ozone transport requirements.
We have reviewed the Wisconsin SIP and have concluded that it meets the general SIP requirements under section 110 of the CAA to the extent these requirements are applicable for purposes of redesignation. EPA has previously approved provisions of Wisconsin's SIP addressing section 110 requirements, including provisions addressing particulate matter, at 40 CFR 52.1870. On January 24, 2011, and June 29, 2012, Wisconsin submitted “infrastructure SIP” elements required by section 110(a)(2) of the CAA. EPA approved elements of Wisconsin's submittals on October 29, 2012, at 77 FR 65478. The requirements of section 110(a)(2), however, are statewide requirements that are not linked to the PM
EPA is proposing to determine that, upon approval of the comprehensive emissions inventories discussed in section IV.B. of this rulemaking, the Wisconsin SIP will meet the applicable SIP requirements for the Milwaukee-Racine Area applicable for purposes of redesignation under part D of the CAA. Subpart 1 of part D, found in sections 172-176 of the CAA, sets forth the basic nonattainment requirements applicable to all nonattainment areas. Subpart 4 of part D, found in sections 185-190 of the CAA, provides more specific requirements for particulate matter nonattainment areas.
For purposes of evaluating these redesignation requests, the applicable section 172 SIP requirements for the Milwaukee-Racine Area are contained in sections 172(c)(1)-(9) of the CAA. A thorough discussion of the requirements contained in section 172 can be found in the General Preamble for Implementation of Title I (57 FR 13498, April 16, 1992).
Section 172(c)(1) requires the plans for all nonattainment areas to provide for the implementation of all Reasonably Available Control Measures (RACM) as expeditiously as practicable and to provide for attainment of the primary NAAQS (health-based NAAQS). EPA interprets this requirement to impose a duty on all nonattainment areas to consider all available control measures and to adopt and implement such measures as are reasonably available for implementation in each area as components of the area's attainment demonstration. Because attainment has been reached in the Milwaukee-Racine Area, no additional measures are needed to provide for attainment, and section 172(c)(1) requirements are no longer considered to be applicable as long as the area continues to attain the standard until redesignation is finalized.
The Reasonable Further Progress (RFP) requirement under section 172(c)(2) is defined as progress that
Section 172(c)(3) requires submission and approval of a comprehensive, accurate, and current inventory of actual emissions. Wisconsin submitted 2006 emissions inventories for direct PM
Section 172(c)(4) requires the identification and quantification of allowable emissions for major new and modified stationary sources in an area, and section 172(c)(5) requires source permits for the construction and operation of new and modified major stationary sources anywhere in the nonattainment area. EPA approved Wisconsin's current NSR program on January 18, 1995 (60 FR 3538). Nonetheless, since PSD requirements will apply after redesignation, the area need not have a fully-approved NSR program for purposes of redesignation, provided that the area demonstrates maintenance of the NAAQS without part D NSR. A detailed rationale for this view is described in a memorandum from Mary Nichols, Assistant Administrator for Air and Radiation, dated October 14, 1994, entitled, “Part D New Source Review Requirements for Areas Requesting Redesignation to Attainment” (Nichols memorandum). Wisconsin has demonstrated that the Milwaukee-Racine Area will be able to maintain the standard without part D NSR in effect; therefore, the state need not have a fully approved part D NSR program prior to approval of the redesignation request. The state's PSD program will become effective in the Milwaukee-Racine Area upon redesignation to attainment.
Section 172(c)(6) requires the SIP to contain control measures necessary to provide for attainment of the standard. Because attainment has been reached, no additional measures are needed to provide for attainment.
Section 172(c)(7) requires the SIP to meet the applicable provisions of section 110(a)(2). As noted above, we find that the Wisconsin SIP meets the section 110(a)(2) requirements applicable for purposes of redesignation.
Section 176(c) of the CAA requires states to establish criteria and procedures to ensure that Federally-supported or funded activities, including highway projects, conform to the air quality planning goals in the applicable SIPs. The requirement to determine conformity applies to transportation plans, programs, and projects developed, funded, or approved under title 23 of the U.S. Code and the Federal Transit Act (transportation conformity) as well as to all other Federally-supported or funded projects (general conformity).
Section 176(c) of the CAA was amended by provisions contained in the Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users (SAFETEA-LU), which was signed into law on August 10, 2005, (Public Law 109-59). Among the changes Congress made to this section of the CAA were streamlined requirements for state transportation conformity SIPs. State transportation conformity regulations must be consistent with Federal conformity regulations and address three specific requirements related to consultation, enforcement and enforceability.
EPA interprets the conformity SIP requirements as not applying for purposes of evaluating the redesignation request under section 107(d) because the requirement to submit SIP revisions to comply with the conformity provisions of the CAA continues to apply to areas after redesignation to attainment, since such areas would be subject to a section 175A maintenance plan. Therefore, because areas are subject to the conformity requirements regardless of whether they are redesignated to attainment, it is reasonable to view these requirements as not applying for purposes of evaluating a redesignation request.
Wisconsin has submitted onroad MVEBs for the Milwaukee-Racine Area of 2.33 tons per winter day
As discussed above, on January 4, 2013, in
Although the Court's ruling did not directly address the 2006 24-hour PM
EPA is proposing to determine that the Court's January 4, 2013, decision does not prevent EPA from
With respect to the 1997 PM
EPA's view that, for purposes of evaluating the Milwaukee-Racine redesignation, the subpart 4 requirements were not due at the time the state submitted the redesignation request is in keeping with the EPA's interpretation of subpart 2 requirements for subpart 1 ozone areas redesignated subsequent to the D.C. Circuit's decision in
EPA's interpretation derives from the provisions of CAA Section 107(d)(3). Section 107(d)(3)(E)(v) states that, for an area to be redesignated, a state must meet “all requirements `applicable' to the area under section 110 and part D”. Section 107(d)(3)(E)(ii) provides that the EPA must have fully approved the “applicable” SIP for the area seeking redesignation. These two sections read together support EPA's interpretation of “applicable” as only those requirements that came due prior to submission of a complete redesignation request. First, holding states to an ongoing obligation to adopt new CAA requirements that arose after the state submitted its redesignation request, in order to be redesignated, would make it problematic or impossible for EPA to act on redesignation requests in accordance with the 18 month deadline Congress set for EPA action in section 107(d)(3)(D). If “applicable requirements” were interpreted to be a continuing flow of requirements with no reasonable limitation, states, after submitting a redesignation request, would be forced continuously to make additional SIP submissions that in turn would require EPA to undertake further notice-and-comment rulemaking actions to act on those submissions. This would create a regime of unceasing rulemaking that would delay action on the redesignation request beyond the 18 month timeframe provided by the CAA for this purpose.
Second, a fundamental premise for redesignating a nonattainment area to attainment is that the area has attained the relevant NAAQS due to emission reductions from existing controls. Thus, an area for which a redesignation request has been submitted would have already attained the NAAQS as a result of satisfying statutory requirements that came due prior to the submission of the request. Absent a showing that unadopted and unimplemented requirements are necessary for future maintenance, it is reasonable to view the requirements applicable for purposes of evaluating the redesignation request as including only those SIP requirements that have already come due. These are the requirements that led to attainment of the NAAQS. To require, for redesignation approval, that a state also satisfy additional SIP requirements
In the context of this redesignation, the timing and nature of the Court's January 4, 2013, decision in
To require the state's fully-completed and pending redesignation request to comply now with requirements of subpart 4 that the Court announced only in its January, 2013, decision on the 1997 PM
Even if EPA were to take the view that the Court's January 4, 2013, decision requires that, in the context of a pending redesignation for the 2006 PM
With respect to evaluating the relevant substantive requirements of subpart 4 for purposes of redesignating the Milwaukee-Racine Area, EPA notes that subpart 4 incorporates components of subpart 1 of part D, which contains general air quality planning requirements for areas designated as nonattainment.
For the purposes of this redesignation, in order to identify any additional requirements that would apply under subpart 4, we are considering the Milwaukee-Racine Area to be a “moderate” PM
The permit requirements of subpart 4, as contained in section 189(a)(1)(A), refer to and apply the subpart 1 permit provisions requirements of sections 172 and 173 to PM
With respect to the specific attainment planning requirements under subpart 4,
The requirements for RFP will not apply in evaluating a request for redesignation to attainment since, at a minimum, the air quality data for the area must show that the area has already attained. Showing that the state will make RFP towards attainment will, therefore, have no meaning at that point.
The General Preamble also explained that:
EPA similarly stated in its 1992 Calcagni memorandum that, “The requirements for reasonable further progress and other measures needed for attainment will not apply for redesignations because they only have meaning for areas not attaining the standard.”
It is evident that even if we were to consider the Court's January 4, 2013, decision in
Moreover, even outside the context of redesignations, EPA has viewed the obligation to submit attainment-related SIP planning requirements of subpart 4 as inapplicable for areas that EPA determines are attaining the standard. EPA's prior “Clean Data Policy” rulemakings for the PM
Elsewhere in this notice, EPA proposes to determine that the area has attained the 2006 24-hour PM
Thus, EPA is proposing to conclude that the requirements to submit an attainment demonstration under 189(a)(1)(B), a RACM determination under section 172(c)(1) and section 189(a)(1)(c), a RFP demonstration under 189(c)(1), and contingency measure requirements under section 172(c)(9) are satisfied for purposes of evaluating the redesignation request.
The D.C. Circuit in
EPA's 1997 PM
The Court in its January 4, 2013, decision made reference to both section 189(e) and 40 CFR 51.1002, and stated that, “In light of our disposition, we need not address the petitioners' challenge to the presumptions in [40 CFR 51.1002] that volatile organic compounds and ammonia are not PM
Elsewhere in its opinion, however, the Court observed:
Ammonia is a precursor to fine particulate matter, making it a precursor to both PM
However, even if EPA takes the view that the requirements of subpart 4 were deemed applicable at the time the state submitted the redesignation request, and disregards the implementation rule's rebuttable presumptions regarding ammonia and VOC as PM
Precursors in subpart 4 are specifically regulated under the provisions of section 189(e), which require, with important exceptions, control requirements for major stationary sources of PM
In the General Preamble, EPA discusses its approach to implementing section 189(e).
EPA's 1997 PM
Although, as EPA has emphasized, its consideration here of precursor requirements under subpart 4 is in the context of a redesignation to attainment, EPA's existing interpretation of subpart 4 requirements with respect to precursors in attainment plans for PM
In sum, even if Wisconsin was required to address precursors for the Milwaukee-Racine Area under subpart 4 rather than under subpart 1, as interpreted in EPA's remanded PM
A discussion of the impact of the Court's decision on the maintenance plan required under sections 175A and 107(d)(3)(E)(iv) can be found in section IV.A.5.d., below.
Upon final approval of Wisconsin's comprehensive emissions inventory, EPA will have fully approved the Wisconsin SIP for the Milwaukee-Racine Area under section 110(k) of the CAA for all requirements applicable for purposes of redesignation. EPA may rely on prior SIP approvals in approving a redesignation request (
EPA finds that Wisconsin has demonstrated that the observed air quality improvement in the Milwaukee-Racine Area is due to permanent and enforceable reductions in emissions resulting from implementation of the SIP, Federal measures, and other state-adopted measures.
In making this showing, Wisconsin has calculated the change in emissions between 2006, one of the years in the period during which the Milwaukee-Racine Area monitored nonattainment, and 2010, one of the years in the period during which the Milwaukee-Racine Area monitored attainment. The reduction in emissions and the corresponding improvement in air quality over this time period can be attributed to a number of regulatory control measures that the Milwaukee-Racine Area and upwind areas have implemented in recent years.
The following is a discussion of permanent and enforceable measures that have been implemented in the area:
A May 7, 2010, consent decree with Saint-Gobain Containers required the Burlington Plant, located in Burlington, Wisconsin, to install oxy-fuel technology and to be subjected to a NO
Reductions in fine particle precursor emissions have occurred statewide and in upwind areas as a result of Federal emission control measures, with additional emission reductions expected to occur in the future. Federal emission control measures include the following:
On December 30, 2011, the D.C. Circuit issued an order addressing the status of CSAPR and CAIR in response to motions filed by numerous parties seeking a stay of CSAPR pending judicial review. In that order, the Court stayed CSAPR pending resolution of the petitions for review of that rule in
On August 21, 2012, the D.C. Circuit issued a decision to vacate CSAPR. In that decision, it also ordered EPA to continue administering CAIR “pending the promulgation of a valid replacement.”
In light of these unique circumstances and for the reasons explained below, to the extent that attainment is due to emission reductions associated with CAIR, EPA is here proposing to determine that those reductions are sufficiently permanent and enforceable for purposes of CAA sections 107(d)(3)(E)(iii) and 175A. EPA therefore proposes to approve the redesignation requests and the related SIP revisions for the Milwaukee-Racine Area, including Wisconsin's plan for maintaining attainment of the PM
As directed by the D.C. Circuit, CAIR remains in place and enforceable until substituted by a valid replacement rule. Wisconsin submitted a CAIR SIP which was approved by EPA on October 16, 2007 (72 FR 58542). In its redesignation request, Wisconsin notes that all potential emission reductions resulting from CAIR and CSAPR have been left out of the maintenance emission inventory projections.
Although Wisconsin is not relying on CAIR in its maintenance plan, the directive from the D.C. Circuit in
Further, in vacating CSAPR and requiring EPA to continue administering CAIR, the D.C. Circuit emphasized that the consequences of vacating CAIR “might be more severe now in light of the reliance interests accumulated over the intervening four years.”
Wisconsin developed annual emissions inventories for VOC, NO
Therefore, it was necessary to construct emission inventories for a time period that is most associated with elevated levels of 24-hour PM
The emission inventories submitted by Wisconsin were developed with the assistance of the Lake Michigan Air Directors Consortium (LADCO). The main purpose of LADCO is to provide technical assessments for and assistance to its member states on problems of air
The 2006 nonattainment inventory was developed as described below. Point source emissions for 2006 were estimated using linear interpolations from 2005 to 2008 emissions inventories. The 2005 and 2008 emissions inventories were created using annually reported point source emissions, EPA's Clean Air Markets Database and approved U.S. EPA techniques for emissions calculation (
Area source sector emissions were created by backcasting the Wisconsin 2008 base year emissions inventory submitted to EPA in 2010 for the National Emissions Inventory. The backcasting factors were primarily based on growth factors from the Economic Growth and Analysis System model.
The 2006 nonroad mobile emission estimates were created by using EPA's National Mobile Inventory (NMIM) model (2009/05/04 Version). The 2006 aircraft, marine and rail emissions were estimated using linear interpolation from the 2005 and 2008 emissions inventories. Pechan provided marine and rail emission estimates via LADCO for Wisconsin. Pechan is an independent contractor, which, through contracts with LADCO, has developed state-specific emission inventory data, including growth factors, for the entire LADCO region. Aircraft emissions were calculated using the Federal Aviation Administration's Emissions and Dispersion Modeling System (EDMS).
The 2006 onroad mobile emission estimates were created by using the EPA's MOVES2010a model.
The 2010 attainment year inventories were developed using the same techniques as those used to develop the nonattainment year inventories.
NO
Table 4 shows that the Milwaukee-Racine Area reduced direct PM
In conjunction with Wisconsin's requests to redesignate the Milwaukee-Racine Area to attainment status, Wisconsin submitted SIP revisions to provide for maintenance of 2006 24-hour PM
Section 175A of the CAA sets forth the required elements of a maintenance plan for areas seeking redesignation from nonattainment to attainment. Under section 175A, the plan must demonstrate continued attainment of the applicable NAAQS for at least ten years after EPA approves a redesignation to attainment. Eight years after redesignation, the state must submit a revised maintenance plan which demonstrates that attainment will continue to be maintained for ten years following the initial ten year maintenance period. To address the possibility of future NAAQS violations, the maintenance plan must contain contingency measures with a schedule for implementation as EPA deems necessary to assure prompt correction of any future PM
The September 4, 1992, John Calcagni memorandum provides additional guidance on the content of a maintenance plan. The memorandum states that a maintenance plan should address the following items: the attainment emissions inventories, a maintenance demonstration showing maintenance for the ten years of the maintenance period, a commitment to maintain the existing monitoring network, factors and procedures to be used for verification of continued attainment of the NAAQS, and a contingency plan to prevent or correct future violations of the NAAQS.
The Wisconsin DNR developed annual emissions inventories for NO
Along with the redesignation requests, Wisconsin submitted revisions to the Wisconsin PM
As discussed in detail in the section below, Wisconsin's maintenance plan submissions expressly document that the area's emissions inventories will remain below the attainment year inventories through 2025. In addition, for the reasons set forth below, EPA believes that the state's submissions, in conjunction with additional supporting information, further demonstrate that the area will continue to maintain the PM
Wisconsin's plan demonstrates maintenance of the 2006 24-hour PM
For NO
Tables 5-8 show that emissions of NO
In addition, as Tables 1 and 2 demonstrate, monitored PM
Based on the information summarized above, Wisconsin has adequately demonstrated maintenance of the PM
With regard to the redesignation of the Milwaukee-Racine nonattainment Area, in evaluating the effect of the Court's remand of EPA's implementation rule, which included presumptions against consideration of VOC and ammonia as PM
EPA finds that the state's maintenance plan shows continued maintenance of the standard by tracking the levels of the precursors whose control brought about attainment of the 2006 24-hour PM
Total ammonia emissions throughout the Milwaukee-Racine Area are very low, estimated to be less than 2,400 tons per year.
Wisconsin's maintenance plan shows that emissions of direct PM
In addition, available
Wisconsin modeling using Round 5 emission files from LADCO updated “Modeled Attainment Test Software (MATS—October 2012)” from EPA, was completed in March, 2013. The predicted 2018 design value is 33 μg/m
Thus, EPA believes that there is ample justification to conclude that the Milwaukee-Racine Area should be redesignated, even taking into consideration the emissions of other precursors potentially relevant to PM
Wisconsin currently operates five monitors for purposes of determining attainment with the 2006 24-hour PM
Continued attainment of the PM
The contingency plan provisions are designed to promptly correct or prevent a violation of the NAAQS that might occur after redesignation of an area to attainment. Section 175A of the CAA requires that a maintenance plan include such contingency measures as EPA deems necessary to assure that the state will promptly correct a violation of the NAAQS that occurs after redesignation. The maintenance plan should identify the contingency measures to be adopted, a schedule and procedure for adoption and implementation of the contingency measures, and a time limit for action by the state. The state should also identify specific indicators to be used to determine when the contingency measures need to be adopted and implemented. The maintenance plan must include a requirement that the state will implement all measures with respect to control of the pollutant(s) that were contained in the SIP before redesignation of the area to attainment.
As required by section 175A of the CAA, Wisconsin has adopted a contingency plan for the Milwaukee-Racine Area to address possible future 24-hour PM
i. Broaden the application of the NO
ii. Consideration of PM
iii. Diesel reduction emissions strategies;
iv. Ammonia emission reduction strategies.
EPA believes that Wisconsin's contingency plan satisfies the pertinent requirements of section 175A(d).
As required by section 175A(b) of the CAA, Wisconsin commits to submit to EPA an updated maintenance plan eight years after redesignation of the
EPA has concluded that the maintenance plan adequately addresses the five basic components of a maintenance plan: attainment inventory, maintenance demonstration, monitoring network, verification of continued attainment, and a contingency plan.
As discussed above in section IV.A.2.a.ii., section 173(c)(3) of the CAA requires areas to submit a comprehensive, accurate and current emissions inventory. As part of the redesignation request, Wisconsin submitted 2006 and 2010 emissions inventories for NO
On May 30, 2013, WDNR supplemented its submittal with a 2007/2008 emissions inventory for ammonia. The additional emissions inventory information provided by the state addresses emissions of ammonia from the general source categories of point sources, area sources, onroad mobile sources, and nonroad mobile sources. The state-submitted emissions inventories were based upon information generated by LADCO in conjunction with its member states and are presented in Table 10 below.
LADCO ran the EMS model using data provided by the state of Wisconsin to generate point source emissions estimates. The point source data supplied by the state was obtained from Wisconsin's source facility emissions reporting.
For area sources, LADCO ran the EMS model using the 2008 National Emissions Inventory (NEI) data provided by Wisconsin. LADCO followed Eastern Regional Technical Advisory Committee (ERTAC) recommendations on area sources when preparing the data. Agricultural ammonia emissions were not taken from NEI; instead emissions were based on Carnegie Mellon University's Ammonia Emission Inventory for the Continental United States (CMU). Specifically, the CMU 2002 annual emissions were grown to reflect 2007 conditions. A process-based ammonia emissions model developed for LADCO was then used to develop temporal factors to reflect the impact of average meteorology on livestock emissions.
Nonroad mobile source emissions were generated using the NMIM2008 emissions model. LADCO also accounted for three other nonroad categories not covered by the NMIM model: Commercial marine vessels, aircraft, and railroads. Marine emissions were based on reports prepared by Environ entitled “LADCO Nonroad Emissions Inventory Project for Locomotive, Commercial Marine, and Recreational Marine Emission Sources, Final Report, December 2004” and “LADCO 2005 Commercial Marine Emissions, Draft, March 2, 2007.” Aircraft emissions were provided by Wisconsin and calculated using AP-42 emission factors and landing and take-off data provided by the Federal Aviation Administration. Rail emissions were based on the 2008 inventory developed by ERTAC.
Onroad mobile source emissions were generated using EPA's MOVES2010a emissions model.
EPA notes that the emissions inventory developed by LADCO is documented in “Regional Air Quality Analyses for Ozone, PM
EPA has concluded that the 2007/2008 ammonia emissions inventory provided by the state is complete and as accurate as possible given the input data available for the relevant source categories. EPA also believes that the inventory provides information about ammonia as a PM
Under the CAA, states are required to submit, at various times, control strategy SIP revisions and maintenance plans for PM
Under 40 CFR part 93, a MVEB for an area seeking a redesignation to attainment is established for the last year of the maintenance plan. The MVEB serves as a ceiling on emissions from an area's planned transportation system. The MVEB concept is further explained in the preamble to the November 24, 1993, transportation conformity rule (58 FR 62188).
Under section 176(c) of the CAA, transportation plans and transportation improvement programs (TIPs) must be evaluated to determine if they conform with the area's SIP. Conformity to the SIP means that transportation activities will not cause new air quality violations, worsen existing air quality violations, or delay timely attainment of the NAAQS or any required interim milestone. If a transportation plan or TIP does not conform, most new transportation projects that would expand the capacity of roadways cannot go forward. Regulations at 40 CFR part 93 set forth EPA policy, criteria, and procedures for demonstrating and assuring conformity of such transportation activities to a SIP.
When reviewing SIP revisions containing MVEBs, including attainment strategies, rate-of-progress plans, and maintenance plans, EPA must affirmatively find “adequate” or approve for use in determining transportation conformity before the MVEBs can be used. Once EPA affirmatively approves or finds the submitted MVEBs to be adequate for transportation conformity purposes, the MVEBs must be used by state and
EPA's process for determining adequacy of a MVEB consists of three basic steps: (1) Providing public notification of a SIP submission; (2) providing the public the opportunity to comment on the MVEB during a public comment period; and, (3) EPA taking action on the MVEB. The process for determining the adequacy of submitted SIP MVEBs is codified at 40 CFR 93.118.
The maintenance plan submitted by Wisconsin for the Milwaukee-Racine Area contains direct PM
Wisconsin did not provide emission budgets for ammonia because it concluded, consistent with the presumptions regarding these precursors in the conformity rule at 40 CFR 93.102(b)(2)(v), which predated and was not disturbed by the litigation on the PM
EPA issued conformity regulations to implement the 1997 PM
First, as noted above, EPA's conformity rule implementing the 1997 PM
EPA has reviewed the submitted budgets for 2015 and 2025, using the conformity rule's adequacy criteria found at 40 CFR 93.118(e)(4). EPA finds that the area can maintain attainment of the 2006 24-hour PM
EPA is proposing to determine that the Milwaukee-Racine Area is attaining the 2006 24-hour PM
Under the CAA, redesignation of an area to attainment and the accompanying approval of a maintenance plan under section 107(d)(3)(E) are actions that affect the status of a geographical area and do not impose any additional regulatory requirements on sources beyond those imposed by state law. A redesignation to attainment does not in and of itself create any new requirements, but rather results in the applicability of requirements contained in the CAA for areas that have been redesignated to attainment. Moreover, 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, these proposed actions do not impose additional requirements beyond those imposed by state law and the CAA. For that reason, these proposed actions:
• Are not “significant regulatory actions” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);
• do not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• are certified as not having a significant economic impact on a
• do 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);
• do not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• are not economically significant regulatory actions based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• are not significant regulatory actions subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• are 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
• do not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, this proposed rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because a determination of attainment is an action that affects the status of a geographical area and does not impose any new regulatory requirements on tribes, impact any existing sources of air pollution on tribal lands, nor impair the maintenance of Fine Particulate national ambient air quality standards in tribal lands.
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Particulate matter.
Environmental protection, Air pollution control, National parks, Wilderness areas.
Fish and Wildlife Service, Interior.
Proposed rule.
We, the U.S. Fish and Wildlife Service (Service), propose to reduce the information collection requirements for participants in the light goose conservation order, which authorizes methods of take to increase harvest of certain populations of light geese in the Atlantic, Central, and Mississippi Flyways, and to reduce the burden on State and tribal wildlife agencies that are required to submit annual light goose harvest reports to the Service. We are taking this action to eliminate information collection and reporting requirements that we believe to be unnecessary. This action would relieve requirements on certain individuals, States, and tribes.
The comment period for this proposed rule closes April 21, 2014.
•
•
We will not accept emailed or faxed comments. We will post all comments on
James Kelley at 612-713-5409.
Greater snow geese, lesser snow geese, and Ross's geese are referred to as “light” geese due to the light coloration of the white-phase plumage morph, as opposed to true “dark” geese such as the white-fronted or Canada goose. We include both plumage variations of lesser snow geese (white, or “snow” and dark, or “blue”) under the designation light geese. Dark phase Ross's geese exist but are uncommon.
Various populations of light geese have undergone rapid growth during the past 30 years, and have become seriously injurious to their habitat, habitat important to other migratory birds, and agricultural interests. We believe that several of these populations have exceeded the long-term carrying capacity of their breeding and/or migration habitats and must be reduced. In 1999, we implemented regulations that authorized new methods of take and created a conservation order to increase harvest of certain populations of light geese in the Central and Mississippi Flyways (64 FR 7507; February 16, 1999). In 2008, we prepared an environmental impact statement and record of decision to
Past changes to the light goose harvest regulations at 50 CFR 21.60 addressed two areas. The first authorized the use of two new hunting methods, electronic calls and unplugged shotguns, to harvest light geese during normal hunting season frameworks. New methods of take were allowed during a light-goose-only hunting season when all other waterfowl and crane hunting seasons, excluding falconry, are closed. Authorization of new methods of take during light-goose-only seasons was allowed only during normal hunting season framework dates (September 1 to March 10), except as provided in 50 CFR part 21, as described below. Individual States and tribes were authorized to determine the exact dates such tools could be used. Persons utilizing new methods of take during light goose hunting seasons were required to possess a Federal migratory bird hunting stamp, to be registered under the Harvest Information Program, and to be in compliance with any additional State or tribal license and stamp requirements pertaining to hunting waterfowl.
The second area revised subpart E of 50 CFR part 21 for the management of overabundant light goose populations. Under this subpart, we established a conservation order specifically for the control and management of light geese. Under the authority of this regulation, States and tribes could initiate aggressive harvest management strategies with the intent to increase light goose harvest without having to obtain an individual permit, which significantly reduced the administrative burden on State, tribal and Federal governments. This regulation enabled States and tribes, as a management tool, to use hunters to harvest light geese, by shooting in a hunting manner, inside or outside of the regular migratory bird hunting season framework dates of September 1 and March 10. Although a conservation order could be implemented at any time, we believe the greatest value of this regulation is the provision of a mechanism to increase harvest of light geese beyond March 10, the latest possible closing date for traditional migratory bird hunting seasons. This provision is especially effective in increasing harvest in mid-latitude and northern States during spring migration. The conservation order is not a hunting season, and implementation of such a regulation should not be construed as opening, re-opening, or extending any open hunting season contrary to any regulations promulgated under section 3 of the Migratory Bird Treaty Act (16 U.S.C. 703-712).
Conditions under the conservation order require that participating States and tribes inform participants acting under the authority of the conservation order of the conditions that apply to the regulation. In order to minimize or avoid take of nontarget species, States and tribes may implement this action only when all waterfowl (including light goose) and crane hunting seasons, excluding falconry, are closed. In addition to authorizing electronic calls and unplugged shotguns, the conservation order does not impose daily bag limits for light geese and allows shooting hours for light geese to end one-half hour after sunset.
Under the regulations at 50 CFR 21.60, States and tribes must keep annual records of activities carried out under the authority of the conservation order. We required the reported information to help us to assess the effectiveness of light geese population control methods and strategies, and to assess whether or not additional population control methods are needed. We believe that sufficient information has been collected since 2000 to allow us to properly evaluate the effectiveness of new methods of take for harvesting light geese. While we are not proposing to eliminate all of the information collection requirements of the conservation order, we believe that the requirements can be simplified, thus reducing the burden on individuals participating in the conservation order, who must provide information to State wildlife agencies, and on State and Tribal wildlife agencies, which are required to submit annual light goose harvest reports to the Service. Currently, 50 CFR 21.60(f)(8) requires States and tribes to keep annual records of the following activities carried out under the authority of the light goose conservation order:
(i) The number of persons participating in the conservation order;
(ii) The number of days people participated in the conservation order;
(iii) The number of persons who pursued light geese with the aid of a shotgun capable of holding more than three shells;
(iv) The number of persons who pursued light geese with the aid of an electronic call;
(v) The number of persons who pursued light geese during the period one-half hour after sunset;
(vi) The total number of light geese shot and retrieved during the conservation order;
(vii) The number of light geese taken with the aid of an electronic call;
(viii) The number of light geese taken with the fourth, fifth, or sixth shotgun shell;
(ix) The number of light geese taken during the period one-half hour after sunset; and
(x) The number of light geese shot but not retrieved.
During 2000-2011, an average of 52,672 hunters in the Central and Mississippi Flyways (combined) spent 250,079 days afield each year during conservation order periods (Table 1). An average of 3,815 hunters in the Atlantic Flyway spent 13,424 days afield during conservation order periods each year from 2009-2011. The annual average harvest of light geese during the conservation order harvest was 697,367 birds in the Central and Mississippi Flyways (combined), and 39,100 birds in the Atlantic Flyway. Half of all conservation order participants chose to utilize electronic calls (51%) and unplugged shotguns (50%), whereas only 28% chose to pursue light geese during the period one-half hour after sunset.
As shown in Table 1, above, electronic calls were used to take approximately 40% of the light geese during the conservation order in the 3 Flyways. Unplugged shotguns were used to take nearly 27% of the light goose harvest in the Central and Mississippi Flyways (combined), but only about 16% in the Atlantic Flyway. Just under 13% of light geese were harvested in the period one-half hour after sunset, compared to the other methods of take. However, it should be noted that two or more methods of take can be utilized simultaneously while pursuing light geese during the conservation order.
These results indicate that the new methods of take authorized during the conservation order have been successful in increasing harvest of light geese in the United States. Although some methods appear to be utilized more by hunters than others, we believe that no changes are needed to the conservation order's authorized methods of take. However, we believe that we no longer need to require States and tribes to collect detailed information on methods of take used to harvest light geese. Public comments from Flyway Councils received during our last renewal of the information collection requirements (see 76 FR 66952; October 28, 2011) indicated that Councils wanted a discontinuation of collection of information on methods of take as well. Therefore, we propose to revise 50 CFR 21.60(f)(8) to require that States and tribes to keep annual records of only the following activities carried out under the authority of the light goose conservation order:
(i) The number of persons participating in the conservation order;
(ii) The number of days people participated in the conservation order;
(iii) The number of light geese shot and retrieved during the conservation order;
(vii) The number of light geese shot but not retrieved.
This level of information collection would continue to allow us to monitor the efficacy of our efforts to increase the harvest of light goose populations that have been deemed overabundant. During our last information collection renewal (see 76 FR 66952; October 28, 2011), the Flyway Councils also commented that the burden of collection of such information should be transferred to the Service from the States. While we agree that having the Service collect such information would provide uniformity in survey sampling, budgetary constraints currently prevent us from initiating new harvest survey efforts for light geese.
Executive Order 12866 provides that the Office of Information and Regulatory Affairs (OIRA) will review all significant rules. OIRA has determined that this rule is not significant.
Executive Order 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this rule in a manner consistent with these requirements.
Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq., as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996 (Pub. L. 104-121)), whenever an agency is required to publish a notice of rulemaking for any proposed or final rule, it must prepare and make available for public comment a regulatory flexibility analysis that describes the effect of the rule on small businesses, small organizations, and small government jurisdictions. However, no regulatory flexibility analysis is required if the head of an agency certifies the rule would not have a significant economic impact on a substantial number of small entities.
SBREFA amended the Regulatory Flexibility Act to require Federal agencies to provide the statement of the factual basis for certifying that a rule would not have a significant economic impact on a substantial number of small entities. This proposed regulation change would not have a significant economic impact on a substantial number of small entities, so a regulatory flexibility analysis is not required.
This proposed rule would reduce the information collection requirements for participants in the light goose conservation order and reduce the burden on State and tribal wildlife agencies that are required to submit annual light goose harvest reports to the Service. It would have no impact on economic activities already associated with the light goose conservation order itself, and therefore would not have an economic effect (benefit) on any small entities.
This is not a major rule under the SBREFA (5 U.S.C. 804 (2)). It would not have a significant impact on a substantial number of small entities.
a. This rule would not have an annual effect on the economy of $100 million or more.
b. This rule would not cause a major increase in costs or prices for consumers, individual industries, Federal, State, Tribal, or local government agencies, or geographic regions.
c. This rule would not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.
In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq.), we have determined the following:
a. This rule would not affect small governments. A small government agency plan is not required.
b. This rule would not produce a Federal mandate. It is not a significant regulatory action.
This proposed rule does not contain a provision for taking of private property. In accordance with Executive Order 12630, a takings implication assessment is not required.
This proposed rule does not have sufficient Federalism effects to warrant preparation of a federalism impact summary statement under Executive Order 13132. It would not interfere with any State's ability to manage itself or its funds. No significant economic impacts are expected to result from the proposed regulations change.
In accordance with Executive Order 12988, the Office of the Solicitor has determined that the rule does not unduly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of the Order.
The Office of Management and Budget has approved the current information collection requirements in 50 CFR Part 21 and assigned OMB Control Number 1018-0103, which expires January 31, 2015. This proposal revises the information collection requirements, and OMB approval is required under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). We may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
We expect a maximum of 39 States and tribes to participate under the authority of the conservation order each year it is available. States and tribes must keep records of activities carried out under the authority of the conservation order. We believe that this recordkeeping requirement is necessary to ensure that those individuals carrying out control activities are authorized to do so. The States and tribes must submit an annual report summarizing the activities conducted under the conservation order. Reported information helps us to assess the effectiveness of light geese population control methods and strategies, and assess whether or not additional population control methods are needed. However, we believe that the number of elements in the information collection requirement can be reduced while maintaining a core of elements that allow us to monitor the number of participants in the conservation order and resulting harvest of birds. We propose that 50 CFR 21.60(f)(8) be revised to require that information be collected only on the number of:
• Persons participating in the conservation order;
• Days people participated in the conservation order;
• Light geese shot and retrieved during the conservation order; and
• Light geese shot but not retrieved.
Each State and tribe determines how they collect data from participants. Though there is no common form or method, the States and tribes have shared their forms and there is commonality. Some States require participants to obtain a permit to participate in the conservation order, others do not. Post-harvest survey questions and questionnaire delivery methods differ among States and tribes. States measure harvest and hunter activity through the use of mail questionnaires, phone surveys, hunter diaries, online data entry, and so forth. Differences also exist within similar survey types, such as the proportion of participants surveyed and the type and number of followup contacts.
As part of our continuing efforts to reduce paperwork and respondent burdens, we invite the public and other Federal agencies to comment on any aspect of the reporting burden associated with this proposed information collection. We specifically invite comments concerning:
• Whether or not the collection of information is necessary, including whether or not the information will have practical utility;
• The accuracy of our estimate of the burden for this collection of information;
• Ways to enhance the quality, utility, and clarity of the information to be collected; and
• Ways to minimize the burden of the collection of information on respondents.
Send comments specific to the information collection aspects of this proposed rule to the Desk Officer for the Department of the Interior at OMB-OIRA at (202) 395-5806 (fax) or
The Department of the Interior's policy is, whenever practicable, to afford the public an opportunity to participate in the rulemaking process. Accordingly, we invite interested persons to submit written comments, suggestions, or recommendations regarding the proposed regulations. Before promulgation of final regulations for managing harvest of light goose populations, we will take into consideration all comments we receive. Such comments, and any additional information we receive, may lead to
You may submit your comments and materials concerning this proposed rule by one of the methods listed in the
We will post all comments in their entirety—including your personal identifying information—on
Comments and materials we receive, as well as supporting documentation we used in preparing this proposed rule, will be available for public inspection on
For each series of proposed rulemakings, we will establish specific comment periods. We will consider, but possibly may not respond in detail to, each comment. As in the past, we will summarize all comments we receive during the comment period and respond to them after the closing date in any final rule.
In compliance with the requirements of section 102(2)(C) of the National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321 et seq.), and the Council on Environmental Quality's regulations for implementing NEPA (40 CFR 1500-1508), the Environmental Protection Agency (EPA) published the availability of a Final EIS on light goose management on July 13, 2007 (72 FR 38577), and we published the same on July 18, 2007 (72 FR 39439), followed by a 30-day public review period. The EPA reviewed the Final EIS and stated that they did not identify any environmental concerns with our preferred alternative, and that the document provided adequate documentation of the potential environmental impacts. The EPA assigned a rating of Lack of Objection to the Final EIS. The Final EIS is available to the public at the location indicated under the
Section 7(a)(2) of the Endangered Species Act (ESA), as amended (16 U.S.C. 1531-1543; 87 Stat. 884) provides that “Each Federal agency shall, in consultation with and with the assistance of the Secretary, insure that any action authorized, funded, or carried out . . . is not likely to jeopardize the continued existence of any endangered species or threatened species or result in the destruction or adverse modification of [critical] habitat . . .” We previously completed section 7 consultation under the ESA for the rule that authorized the light goose regulations (73 FR 65926). This proposed rule would only affect information collection and reporting requirements, and we have determined that a section 7 consultation is not necessary.
Executive Order 13211 requires agencies to prepare Statements of Energy Effects when undertaking certain actions. This rule is not a significant regulatory action under E.O. 13211, and would not adversely affect energy supplies, distribution, or use. This action is not a significant energy action, so no Statement of Energy Effects is required.
In accordance with the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 22951), E.O. 13175, and 512 DM 2, we have determined that this rule has very little effect on Federally recognized Indian tribes. This proposal would reduce the information collection and reporting requirements associated with the light goose conservation order, but we expect this reduction would have very little effect on tribes due to low participation rates.
Exports, Hunting, Imports, Reporting and recordkeeping requirements, Transportation, Wildlife.
For the reasons stated in the preamble, we hereby propose to amend part 21, of subchapter B, chapter I, title 50 of the Code of Federal Regulations, as set forth below:
16 U.S.C. 703-712.
(f) * * *
(8) States and tribes must keep annual records of activities carried out under the authority of the conservation order. Specifically, information must be collected on:
(i) The number of persons participating in the conservation order;
(ii) The number of days people participated in the conservation order;
(iii) The number of light geese shot and retrieved during the conservation order; and
(iv) The number of light geese shot but not retrieved.
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments regarding (a) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Comments regarding this information collection received by March 20, 2014 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725—17th Street NW., Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to: OIRA_Submission@OMB.EOP.GOV or fax (202) 395-5806 and to Departmental Clearance Office, USDA, OCIO, Mail Stop 7602, Washington, DC 20250-7602. Copies of the submission(s) may be obtained by calling (202) 720-8958.
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
Forest Service, USDA.
Notice of intent to prepare an environmental impact statement.
The Klamath National Forest will prepare an environmental impact statement (EIS) to document and publicly disclose the environmental effects of treatments proposed to: Promote the continued development and retention of late successional old growth conditions; promote resilience of early- and mid-seral vegetation to large scale disturbance events such as wildfire or insects and disease; restore and maintain pine/oak forest type, oak woodlands, and wildlife habitat; and, reduce wildfire threat and potential fire intensity within the Wildland Urban Interface, especially surrounding private residences and structures. Treatments are proposed on about 2,700 acres and consist of commercial and non-commercial thinning, and, piling and burning of activity generated fuels. The project area is located east of Horse Creek, in Siskiyou County, California. Legal location: Township 46 North Range 9 West Sections 9, 10, 15-22, 27-33; and Township 46 North Range 10 West Sections 13, 21-28, and 32-36; Mount Diablo Meridian.
Comments concerning the scope of the analysis must be received by March 20, 2014. The draft environmental impact statement is expected December 2014 and the final environmental impact statement is expected June 2015.
Send written comments to Patricia A. Grantham, ATTN: Kim Crider, Project Leader, Happy Camp/Oak Knoll Ranger District, 63822 Highway 96, Klamath National Forest, Happy Camp, California 96039. Submit electronic comments at the Klamath
Kim Crider, Project Leader, phone: 530-493-1724, email:
A Forest Service interdisciplinary team composed of specialists from a wide array of disciplines in conjunction with interested parties, considered the need for change and potential actions in the project area. The collaboration efforts included a public meeting and field trip. The IDT identified the following purpose and need for the project by comparing the existing conditions in the project area with the desired conditions described in the Klamath National Forest Land and Resource Management Plan and Late Successional Reserve Assessments: (1) Promote the continued development and retention of Late Successional Old Growth conditions; (2) Promote resilience of early- and mid-seral vegetation to large-scale disturbance events such as wildfire or insects and disease; (3) Restore and maintain pine/oak forest type, oak woodlands, and wildlife habitat; and (4) Reduce wildfire threat and potential fire intensity within the WUI, especially surrounding private residences and structures.
The Klamath National Forest proposes actions to move the project area from the existing condition to the desired condition. Project design features and best management practices are incorporated into the proposed action. Acres by treatment type are described below and do not account for the overlap in treatment types. Treatment acreages are approximate at this point and may be adjusted and refined following the opportunity to provide scoping comments.
No roads will be added to, or removed from, the National Forest Transportation System as part of this project. To facilitate commercial treatments and reduce log skidding distances and associated impacts to soils and other resources, the proposed action includes temporary access along sixteen segments of existing roadbeds totaling about 1.34 miles and 0.36 miles of new temporary roadbed construction within the project area. Both existing and new temporary roadbeds will be closed, and where needed, hydrologically stabilized following project implementation.
About 137 landings will be needed to treat commercial units. Of these, 125 are existing landings and about twelve new landings will be constructed. About102 landings will be roadside continuous landings averaging one-tenth of an acre in size. Thirty-five landings will be needed for ground based units; landings will average from one-third to one-half acre in size.
Patricia A. Grantham, Klamath National Forest Supervisor.
The responsible official will decide whether to adopt and implement the proposed action, an alternative to the proposed action, or take no action to change existing conditions within the project area.
This notice of intent initiates the scoping process, which guides the development of the environmental impact statement. To assist the Forest Service in identifying and considering issues and concerns on the proposed action, comments should be as specific as possible. We are particularly interested in hearing about any potential issues, which are defined as points of discussion, dispute, or debate about the effects of the proposed action. Your participation will help the interdisciplinary team develop effective, issue-driven alternatives and mitigations to the proposed action as needed.
It is important that reviewers provide their comments at such times and in such manner that they are useful to the
Comments received in response to this solicitation, including names and addresses of those who comment, will be part of the public record for this proposed action. Comments submitted anonymously will be accepted and considered, however.
Office of the Secretary, Office of the Chief Information Officer, Commerce.
Notice.
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Comments must be submitted April 21, 2014.
Written comments may be submitted to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW., Washington, DC 20230 (or via the Internet at
Requests for additional information or copies of the information collection instrument and instructions should be directed to Glenna Mickelson at
Executive Order 12862 directs Federal agencies to provide service to the public that matches or exceeds the best service available in the private sector. In order to work continuously to ensure that the Department of Commerce (DOC) programs are effective and meet our customers' needs we use a generic clearance process to collect qualitative feedback on our service delivery. This collection of information is necessary to enable DOC to garner customer and stakeholder feedback in an efficient, timely manner, in accordance with our commitment to improving service delivery. The information collected from our customers and stakeholders will help ensure that users have an effective, efficient, and satisfying experience with the programs. This feedback will provide insights into customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative and actionable communications between DOC and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management.
Feedback collected under this generic clearance will provide useful information, but it will not yield data that can be generalized to the overall population. This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance.
This request is an extension of the `generic fast-track' process offered to all government agencies by OMB in 2010. Fast-track means each request receives approval five days after submission, if no issues are brought to DOC's attention by OMB within the five days. Since 2011, DOC has successfully submitted 68 generic requests to OMB.
The primary method of collection will be the Internet (electronically), paper format, email, fax, interviews, etc.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice sill be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
Bureau of Economic Analysis, Commerce.
Notice of reporting requirements.
By this Notice, the Bureau of Economic Analysis (BEA), Department of Commerce, is informing the public that it is conducting the mandatory survey titled Quarterly Survey of Transactions in Selected Services and Intellectual Property with Foreign Persons (BE-125). This mandatory survey is conducted under the authority of the International Investment and Trade in Services Survey Act.
This Notice constitutes legal notification to all United States persons (defined
(a)
(b)
(c)
22 U.S.C. 3101-3108, as amended.
Bureau of Economic Analysis, Commerce.
Notice of reporting requirements.
By this Notice, the Bureau of Economic Analysis (BEA), Department of Commerce, is informing the public that it is conducting a mandatory survey titled Survey of U.S. Airline Operators' Foreign Revenues and Expenses (BE-37). This mandatory survey is conducted under the authority of the International Investment and Trade in Services Survey Act.
This Notice constitutes legal notification to all United States persons (defined below) who meet the reporting requirements set forth in this Notice that they must respond to, and comply with, the survey. Reports are due 45 days after the end of each calendar quarter. This notice is being issued in conformance with the rule BEA issued in 2012 (77 FR 24373) establishing guidelines for collecting data on international trade in services and direct investment through notices, rather than through rulemakings. The BE-37 survey forms and instructions are available on the BEA Web site at
(a)
(b)
(c)
22 U.S.C. 3101-3108, as amended.
The Transportation and Related Equipment Technical Advisory Committee will meet on March 5, 2014, 9:30 a.m., in the Herbert C. Hoover Building, Room 3884, 14th Street between Constitution & Pennsylvania Avenues, NW., Washington, DC. The Committee advises the Office of the Assistant Secretary for Export Administration with respect to technical questions that affect the level of export controls applicable to transportation and related equipment or technology.
1. Welcome and Introductions.
2. Status reports by working group chairs.
3. Public comments and Proposals.
4. Discussion of matters determined to be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 §§ 10(a)(1) and 10(a)(3).
The open session will be accessible via teleconference to 20 participants on a first come, first serve basis. To join the conference, submit inquiries to Ms. Yvette Springer at
A limited number of seats will be available during the public session of the meeting. Reservations are not accepted. To the extent time permits, members of the public may present oral statements to the Committee. The public may submit written statements at any time before or after the meeting. However, to facilitate distribution of public presentation materials to Committee members, the Committee suggests that presenters forward the public presentation materials prior to the meeting to Ms. Springer via email.
The Assistant Secretary for Administration, with the concurrence of the delegate of the General Counsel, formally determined on December 30, 2013, pursuant to Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. app. 2 § (10)(d)), that the portion of the meeting dealing with pre-decisional changes to the Commerce Control List and U.S. export control policies shall be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 §§ 10(a)(1) and 10(a)(3). The remaining portions of the meeting will be open to the public.
For more information, call Yvette Springer at (202) 482-2813.
The Regulations and Procedures Technical Advisory Committee (RPTAC) will meet March 4, 2014, 9:00 a.m., Room 3884, in the Herbert C. Hoover Building, 14th Street between Constitution and Pennsylvania Avenues NW., Washington, DC. The Committee advises the Office of the Assistant Secretary for Export Administration on implementation of the Export Administration Regulations (EAR) and provides for continuing review to update the EAR as needed.
The open session will be accessible via teleconference to 20 participants on a first come, first serve basis. To join the conference, submit inquiries to Ms. Yvette Springer at
A limited number of seats will be available for the public session. Reservations are not accepted. To the extent that time permits, members of the public may present oral statements to the Committee. The public may submit written statements at any time before or after the meeting. However, to facilitate the distribution of public presentation materials to the Committee members, the Committee suggests that presenters forward the public presentation materials prior to the meeting to Ms. Springer via email.
For more information, call Yvette Springer at (202) 482-2813.
The Materials Processing Equipment Technical Advisory Committee (MPETAC) will meet on March 11, 2014, 9:00 a.m., Room 3884, in the Herbert C. Hoover Building, 14th Street between Pennsylvania and Constitution Avenues NW., Washington, DC. The Committee advises the Office of the Assistant Secretary for Export Administration with respect to technical questions that affect the level of export controls applicable to materials processing equipment and related technology.
1. Opening remarks and introductions.
2. Presentation of papers and comments by the Public.
3. Discussions on results from last, and proposals for next Wassenaar meeting.
4. Report on proposed and recently issued changes to the Export Administration Regulations.
5. Other business.
6. Discussion of matters determined to be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 §§ 10(a)(1) and 10(a)(3).
The open session will be accessible via teleconference to 20 participants on a first come, first serve basis. To join the conference, submit inquiries to Ms. Yvette Springer at
A limited number of seats will be available for the public session. Reservations are not accepted. To the extent that time permits, members of the public may present oral statements to the Committee. The public may submit written statements at any time before or after the meeting. However, to facilitate the distribution of public presentation materials to the Committee members, the Committee suggests that presenters forward the public presentation materials prior to the meeting to Ms. Springer via email.
The Assistant Secretary for Administration, with the concurrence of the delegate of the General Counsel, formally determined on February 20, 2013, pursuant to Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. app. 2 § 10(d)), that the portion of the meeting dealing with matters the premature disclosure of which would be likely to frustrate significantly implementation of a proposed agency action as described in 5 U.S.C. 552b(c)(9)(B) shall be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 §§ 10(a)(1) and 10(a)(3). The remaining portions of the meeting will be open to the public.
For more information, call Yvette Springer at (202) 482-2813.
Enforcement and Compliance, formerly Import Administration, International Trade Administration, Department of Commerce.
The Department of Commerce (“Department”) has preliminarily determined that critical circumstances exist with respect to imports of subject merchandise in the countervailing duty (“CVD”) investigation of steel threaded rod from India, with the exception of imports from Mangal Steel Enterprises Limited (“Mangal Steel”).
Andrew Medley, AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, Room 4416, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: 202-482-4987.
On June 27, 2013, the Department received a CVD Petition concerning imports of steel threaded rod from India filed in proper form by All America Threaded Products Inc.; Bay Standard Manufacturing Inc.; and Vulcan Threaded Products Inc. (collectively, “Petitioners”).
On January 10, 2014, Petitioners alleged that critical circumstances exist with respect to imports of steel threaded rod from India and submitted U.S. Census Bureau import data in support of their allegation. On January 17, 2014, the Department requested from Mangal Steel monthly shipment data of subject merchandise to the United States for the period February 2013 through November 2013. On January 22, 2014, Mangal Steel submitted the requested data.
The period for which we are measuring subsidies, or the period of investigation (“POI”), is calendar year 2012.
The merchandise covered by this investigation is steel threaded rod. Steel threaded rod is certain threaded rod, bar, or studs, of carbon quality steel, having a solid, circular cross section, of any diameter, in any straight length, that have been forged, turned, cold-drawn, cold-rolled, machine straightened, or otherwise cold-finished, and into which threaded grooves have been applied. In addition, the steel threaded rod, bar, or studs subject to this investigation are non-headed and threaded along greater than 25 percent of their total length. A variety of finishes or coatings, such as plain oil finish as a temporary rust protectant, zinc coating (
In their critical circumstances allegation, Petitioners allege that there is a reasonable basis to believe that there are subsidies in this investigation which are inconsistent with the World Trade Organization Agreement on Subsidies and Countervailing Measures (“Subsidies Agreement”). Petitioners cite to the
Petitioners also claim that there have been massive imports of steel threaded rod in the five months following the filing of the Petition on June 27, 2013. Petitioners provided data which they contend demonstrate that imports of subject merchandise increased by more than 15 percent, which is required to be considered “massive” under 19 CFR 351.206(h)(2).
Section 703(e)(1) of the Tariff Act of 1930, as amended (“the Act”) provides that the Department will determine that critical circumstances exist if there is a reasonable basis to believe or suspect that: (A) The alleged countervailable subsidy is inconsistent with the Subsidies Agreement, and (B) there have been massive imports of the subject merchandise over a relatively short period.
When determining whether an alleged countervailable subsidy is inconsistent with the Subsidies Agreement, the Department limits its findings to those subsidies contingent on export performance or use of domestic over imported goods (
In determining whether imports of the subject merchandise have been “massive,” 19 CFR 351.206(h)(1) provides that the Department normally will examine: (i) The volume and value of the imports; (ii) seasonal trends; and (iii) the share of domestic consumption accounted for by the imports. In addition, the Department will not consider imports to be massive unless imports during the “relatively short period” (comparison period) have increased by at least 15 percent compared to imports during an “immediately preceding period of comparable duration” (base period).
19 CFR 351.206(i) defines “relatively short period” as normally being the period beginning on the date the proceeding commences (
In the
In determining whether there were massive imports from Mangal Steel, we analyzed Mangal Steel's monthly shipment data for the period February 2013 through November 2013. These data indicate that there was not a massive increase in shipments of subject merchandise to the United States by Mangal Steel during the five-month period immediately following the filing of the Petition on June 27, 2013.
Because Babu is not participating in this investigation,
With regard to whether imports of subject merchandise by the “all other” exporters of steel threaded rod from India were massive, we preliminarily determine that because there is evidence of the existence of countervailable subsidies that are inconsistent with the Subsidies Agreement, an analysis is warranted as to whether there was a massive increase in shipments by the “all other” companies, in accordance with section 703(e)(1)(B) of the Act and 19 CFR 351.206(h). Therefore, we analyzed, in accordance with 19 CFR 351.206(i), monthly shipment data for the period February 2013 through November 2013, using shipment data from the U.S. Census Bureau, adjusted to remove shipments reported by the only exporter actively participating in this investigation, Mangal Steel.
We preliminarily determine that critical circumstances do not exist with regard to shipments from one mandatory respondent, Mangal Steel and, as AFA, preliminarily determine that critical circumstances exist with regard to shipments from the other mandatory respondent, Babu. We also preliminarily determine, based on our analysis of the shipment data on the record, that critical circumstances exist for imports from “all other” exporters of
In accordance with section 703(e)(2)(A) of the Act, we are directing U.S. Customs and Border Protection to suspend liquidation, with regards to all exporters except Mangal Steel, of any unliquidated entries of subject merchandise from the India entered, or withdrawn from warehouse for consumption, on or after September 20, 2013, which is 90 days prior to the date of publication of the
In accordance with section 703(f) of the Act, we will notify the ITC of our determination.
This determination is issued and published pursuant to sections 703(f) and 777(i)(1) of the Act.
Enforcement and Compliance, formerly Import Administration, International Trade Administration, Department of Commerce.
The Department of Commerce (the “Department”) preliminarily determines that steel threaded rod from India is being, or is likely to be, sold in the United States at less than fair value (“LTFV”), as provided in section 733(b) of the Tariff Act of 1930, as amended (the “Act”). The period of investigation (“POI”) is April 1, 2012, through March 31, 2013. The estimated weighted-average dumping margins of sales at LTFV are listed in the “Preliminary Determination” section of this notice. Interested parties are invited to comment on this preliminary determination.
Paul Stolz or Raquel Silva, AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-4474 or (202) 482-6475.
The merchandise covered by this investigation is steel threaded rod. Steel threaded rod is certain threaded rod, bar, or studs, of carbon quality steel, having a solid, circular cross section, of any diameter, in any straight length, that have been forged, turned, cold-drawn, cold-rolled, machine straightened, or otherwise cold-finished, and into which threaded grooves have been applied. In addition, the steel threaded rod, bar, or studs subject to this investigation are non-headed and threaded along greater than 25 percent of their total length. A variety of finishes or coatings, such as plain oil finish as a temporary rust protectant, zinc coating (
Pursuant to section 735(a)(2) of the Act, on December 13, 2013, and December 18, 2013, Petitioners
Based on the evidence presented in Mangal's questionnaire responses, we preliminarily find that Mangal and Corona Steel Industries Private Limited (“Corona”) are affiliated pursuant to sections 771(33)(A) and (F) of the Act.
In addition, based on the evidence presented in the questionnaire responses, we preliminarily find that Mangal and Corona should not be treated as a single entity for the purposes of this investigation. This
The Department has conducted this investigation in accordance with section 731 of the Act. Export prices (“EPs”) have been calculated in accordance with section 772 of the Act. Constructed export prices (“CEPs”) have been calculated in accordance with section 772(b) of the Act. Normal value (“NV”) has been calculated in accordance with section 773 of the Act. Because the mandatory respondent, Babu Exports (“Babu”), failed to respond to the Department's questionnaire, we have preliminarily determined to apply adverse facts available to this respondent, in accordance with sections 776(a) and (b) of the Act and 19 CFR 351.308. The critical circumstances allegation has been analyzed in accordance with section 733(e)(1) of the Act and 19 CFR 351.206.
For a full description of the methodology underlying our conclusions,
On January 10, 2014, Petitioners filed a timely critical circumstances allegation, pursuant to section 773(e)(1) of the Act and 19 CFR 351.206(c)(1), alleging that critical circumstances exist with respect to imports of the merchandise under consideration.
We preliminary determine the weighted-average dumping margins are as follows:
Section 735(c)(5)(A) of the Act provides that the estimated “all others” rate shall be an amount equal to the weighted average of the estimated weighted-average dumping margins established for exporters and producers individually investigated, excluding any zero or
The Department intends to disclose to parties the calculations performed in connection with this preliminary determination within five days of the date of publication of this notice.
Interested parties are invited to comment on the preliminary determination. Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance via IA ACCESS no later than seven days after the date on which the final verification report is issued in this proceeding. Rebuttal briefs, the content of which is limited to the issues raised in the case briefs, must be filed within five days from the deadline date for the submission of case briefs.
In accordance with section 774 of the Act, the Department will hold a hearing, if timely requested, to afford interested parties an opportunity to comment on arguments raised in case or rebuttal briefs, provided that such a hearing is requested by an interested party.
In accordance with section 733(d)(2) of the Act, we will direct U.S. Customs and Border Protection (“CBP”) to suspend liquidation of all entries of steel threaded rod from India, as described in the “Scope of the Investigation” section, entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the
Furthermore, consistent with our practice, where the product under investigation is also subject to a concurrent countervailing duty investigation, we instruct CBP to require a cash deposit
Pursuant to 19 CFR 351.205(d), the Department will instruct CBP to require a cash deposit
In accordance with section 733(f) of the Act, we will notify the ITC of our preliminary affirmative determination of sales at LTFV. If our final determination in this proceeding is affirmative, section 735(b)(2) of the Act requires that the ITC make its final determination as to whether the domestic industry in the United States is materially injured, or threatened with material injury, by reason of imports of steel threaded rod from India before the later of 120 days after the date of this preliminary determination or 45 days after our final determination.
This determination is issued and published pursuant to sections 733(f) and 777(i)(1) of the Act and 19 CFR 351.205(c).
This determination is issued and published pursuant to sections 733(f) and 777(i)(1) of the Act and 19 CFR 351.205(c).
The merchandise covered by this investigation is steel threaded rod. Steel threaded rod is certain threaded rod, bar, or studs, of carbon quality steel, having a solid, circular cross section, of any diameter, in any straight length, that have been forged, turned, cold-drawn, cold-rolled, machine straightened, or otherwise cold-finished, and into which threaded grooves have been applied. In addition, the steel threaded rod, bar, or studs subject to this investigation are nonheaded and threaded along greater than 25 percent of their total length. A variety of finishes or coatings, such as plain oil finish as a temporary rust protectant, zinc coating (
Included in the scope of this investigation are steel threaded rod, bar, or studs, in which: (1) iron predominates, by weight, over each of the other contained elements; (2) the carbon content is 2 percent or less, by weight; and (3) none of the elements listed below exceeds the quantity, by weight, respectively indicated:
• 1.80 percent of manganese, or
• 1.50 percent of silicon, or
• 1.00 percent of copper, or
• 0.50 percent of aluminum, or
• 1.25 percent of chromium, or
• 0.30 percent of cobalt, or
• 0.40 percent of lead, or
• 1.25 percent of nickel, or
• 0.30 percent of tungsten, or
• 0.012 percent of boron, or
• 0.10 percent of molybdenum, or
• 0.10 percent of niobium, or
• 0.41 percent of titanium, or
• 0.15 percent of vanadium, or
• 0.15 percent of zirconium.
Steel threaded rod is currently classifiable under subheadings 7318.15.5051, 7318.15.5056, 7318.15.5090 and 7318.15.2095 of the Harmonized Tariff Schedule of the United States (“HTSUS”). Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the merchandise is dispositive.
Excluded from the scope of this investigation are: (a) threaded rod, bar, or studs which are threaded only on one or both ends and the threading covers 25 percent or less of the total length; and (b) threaded rod, bar, or studs made to American Society for Testing and Materials (“ASTM”) A193 Grade B7, ASTM A193 Grade B7M, ASTM A193 Grade B16, and ASTM A320 Grade L7.
National Institute of Standards and Technology (NIST), Department of Commerce.
Notice.
This notice announces the issuance of the Cybersecurity Framework (the “Cybersecurity Framework” or “Framework”). The Framework was developed by NIST using information collected through the Request for Information (RFI) that was published in the
The Cybersecurity Framework was published on February 12, 2014.
The Cybersecurity Framework is available electronically from the NIST Web site at: http://www.nist.gov/cyberframework
Diane Honeycutt, telephone: 301-975-8443, National Institute of Standards and Technology, 100 Bureau Drive, Stop 8930, Gaithersburg, MD 20899-8930 or via email:
The national and economic security of the United States depends on the reliable functioning of critical infrastructure,
Under the Executive Order,
The Cybersecurity Framework provides a prioritized, flexible, repeatable, performance-based, and cost-effective approach, including information security measures and controls to help owners and operators of critical infrastructure and other interested entities to identify, assess, and manage cybersecurity-related risk while protecting business confidentiality, individual privacy and civil liberties. To enable technical innovation and account for organizational differences, the Cybersecurity Framework does not prescribe particular technological solutions or specifications. It includes guidance for measuring the performance of an entity in implementing the Cybersecurity Framework and includes methodologies to identify and mitigate impacts of the Framework and associated information security measures and controls on business
As a non-regulatory Federal agency, NIST developed the Framework in a manner that is consistent with its mission to promote U.S. innovation and industrial competitiveness through the development of standards and guidelines in consultation with stakeholders in both government and industry. The Framework provides owners and operators of critical infrastructure the ability to implement security practices in the most effective manner while allowing organizations to express requirements to multiple authorities and regulators. Issues relating to harmonization of existing relevant standards and integration with existing frameworks were also considered. While the focus is on the Nation's critical infrastructure, the Framework was developed in a manner to promote wide adoption of practices to increase cybersecurity across all sectors and industry types.
The Framework was developed through an open public review and comment process that included information collected through a Request for Information (RFI), a series of public workshops, and a 45-day public comment period on the preliminary version of the Cybersecurity Framework (“preliminary Framework”).
NIST published the RFI in the
NIST held five open public workshops to provide the public with additional opportunities to provide input. The first workshop was conducted on April 3, 2013, at the Department of Commerce in Washington, DC The second workshop was conducted on May 29-31, 2013, at Carnegie Mellon University in Pittsburgh, Pennsylvania. The third workshop was conducted on July 10-12, 2013, at the University of California, San Diego. The fourth workshop was conducted on September 11-13, 2013, at the University of Texas at Dallas. The fifth workshop was conducted on November 14-15, 2013, at the North Carolina State University in Raleigh, North Carolina. Agenda, discussion materials, and presentation slides for each of these workshops are available at
NIST issued the preliminary Framework and announced a 45-day public comment period in the
Throughout the process, NIST issued public updates on the development of the Cybersecurity Framework.
NIST issued the first update on June 18, 2013, and it is available at
NIST issued the third update on December 4, 2013, and it is available at
NIST issued the fourth update on January 15, 2014, and it is available at
The Framework incorporates existing consensus-based standards to the fullest extent possible, consistent with requirements of the National Technology Transfer and Advancement Act of 1995,
National Oceanic and Atmospheric Administration, Commerce.
Notice.
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Written comments must be submitted on or before April 21, 2014.
Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW., Washington, DC 20230 (or via the Internet at
Requests for additional information or copies of the information collection instrument and instructions should be directed to Steve Kokkinakis at 240-533-9021 or
This request is for revision and extension of a currently approved information collection.
The National Environmental Policy Act (NEPA) (42 U.S.C. 4321-4347) and
The Environmental Questionnaire and Checklist (EQC) provides federal financial assistance applicants and DOC staff with a tool to ensure that the necessary project and environmental information is obtained. The EQC was developed to collect data concerning potential environmental impacts that the applicant for federal financial assistance possesses and to transmit that information to the Federal reviewer. The EQC will allow for a more rapid review of projects and facilitate DOC's evaluation of the potential environmental impacts of a project and level of NEPA documentation required. DOC staff will use the information provided in answers to the questionnaire to determine compliance requirements for NEPA and conduct subsequent NEPA analysis as needed. Information provided in the questionnaire may also be used for other regulatory review requirements associated with the proposed project, such as the National Historic Preservation Act.
Revision: The checklist is being revised to improve understanding and clarity of the questions.
The main method of submission is electronic. Some supporting documents may be mailed.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meetings.
The Gulf of Mexico Fishery Management Council (Council) will hold meetings of the Shrimp and Ad Hoc Artificial Substrate Advisory Panels.
The meeting will be held from 8:30 a.m. on Wednesday, March 5 until 4:30 p.m. on Thursday, March 6, 2014.
The meetings will be held at the Hilton St. Petersburg Bayfront Hotel, 333—1st Street, St. Petersburg, FL 33701; telephone: (727) 894-5000.
Dr. John Froeschke, Fishery Biologist and Statistician or Dr. Morgan Kilgour, Fishery Biologist, Gulf of Mexico Fishery Management Council; telephone: (813) 348-1630; fax: (813) 348-1711; emails:
The items of discussion in the individual meeting agendas 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 these meetings. Action will be restricted to those issues
These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Kathy Pereira at the Council 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; proposed incidental harassment authorization; request for comments.
NMFS has received an application from the St. George Reef Lighthouse Preservation Society (Society), for an Incidental Harassment Authorization (Authorization) to take marine mammals, by harassment incidental to conducting aircraft operations, lighthouse renovation, and light maintenance activities on the St. George Reef Light Station on Northwest Seal Rock (NWSR) in the northeast Pacific Ocean. The proposed dates for this action would be April 2014 through March 2015. Per the Marine Mammal Protection Act, we are requesting comments on our proposal to issue an Authorization to the Society to incidentally take, by Level B harassment only, marine mammals during the specified activity.
Comments and information must be received on or before March 20, 2014.
Comments on the application should be addressed to Jolie Harrison, Supervisor, Incidental Take Program, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service, 1315 East-West Highway, Silver Spring, MD 20910. The mailbox address for providing email comments is
To obtain an electronic copy of the application containing a list of the references used in this document, write to the previously mentioned address, telephone the contact listed here (see
The Environmental Assessment (EA) specific to conducting aircraft operations, restoration, and maintenance work on the light station is also available at the same internet address. Information in the EA and this notice collectively provide the environmental information related to the proposed issuance of the Authorization for public review and comment. The public may also view documents cited in this notice, by appointment, during regular business hours, at the aforementioned address.
Jeannine Cody, NMFS, Office of Protected Resources, NMFS (301) 713-8401.
Section 101(a)(5)(D) of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361
An authorization shall be granted for the incidental taking of small numbers of marine mammals if NMFS finds that the taking will have a negligible impact on the species or stock(s), and will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant). The authorization must also set forth the permissible methods of taking; other means of effecting the least practicable adverse impact on the species or stock and its habitat; and requirements pertaining to the mitigation, monitoring and reporting of such taking. NMFS has defined “negligible impact” in 50 CFR 216.103 as “an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.”
Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as: Any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild [Level A harassment]; or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering [Level B harassment].
On December 14, 2013, NMFS received an application from the Society requesting that we issue an Authorization for the take of marine mammals, incidental to conducting restoration activities on the St. George Reef Light Station (Station) located on Northwest Seal Rock offshore of Crescent City, California in the northeast Pacific Ocean. NMS determined the application complete and adequate on January 13, 2014.
The Society proposes to conduct aircraft operations, lighthouse renovation, and periodic maintenance on the Station's optical light system on a monthly basis. The proposed activity would occur on a monthly basis over one weekend, April 1 through April 30, 2014 and November 1, 2014, through
To date, we have issued four, Authorizations to the Society for the conduct of the same activities from 2010 to 2013 (75 FR 4774, January 29, 2010; 76 FR 10564, February 25, 2011; 77 FR 8811, February 15, 2012; and 79 FR 6179, February 3, 2014). This is the Society's fifth request for an annual Authorization as their last Authorization expired on December 31, 2013.
The Station, listed in the National Park Service's National Register of Historic Places, is located on Northwest Seal Rock offshore of Crescent City, California in the northeast Pacific Ocean. The Station, built in 1892, rises 45.7 meters (m) (150 feet (ft)) above sea level. The structure consists of hundreds of granite blocks topped with a cast iron lantern room and covers much of the surface of the islet. The purpose of the project is to restore the lighthouse and to conduct annual and emergency maintenance on the Station's optical light system.
The Society proposes to conduct the activities (aircraft operations, lighthouse restoration, and maintenance activities) from the period of April 1, 2014 through March 31, 2015, at a maximum frequency of one session per month. The proposed duration for each session would last no more than three days (e.g., Friday, Saturday, and Sunday). The proposed Authorization, if issued, would be effective from April 1, 2014 through April 30, 2014 and November 1, 2014, through March 31, 2015.
We refer the reader to the Detailed Description of Activities section later in this notice for more information on the scope of the proposed activities.
The Station is located on a small, rocky islet (41°50′24″ N, 124°22′06″ W) approximately nine kilometers (km) (6.0 miles (mi)) in the northeast Pacific Ocean, offshore of Crescent City, California (Latitude: 41°46′48″ N; Longitude: 124°14′11″ W). NWSR is approximately 91.4 m (300 ft) in diameter that peaks at 5.18 m (17 ft) above mean sea level.
Because Northwest Seal Rock has no safe landing area for boats, the proposed restoration activities would require the Society to transport personnel and equipment from the California mainland to Northwest Seal Rock by a small helicopter. Helicopter landings take place on top of the engine room (caisson) which is approximately 15 m (48 ft) above the surface of the rocks on Northwest Seal Rock. The Society plans to charter a Raven R44 helicopter, owned and operated by Air Shasta Rotor and Wing, LLC. The Raven R44, which seats three passengers and one pilot, is a compact-sized (1134 kilograms (kg), 2500 pounds (lbs)) helicopter with two-bladed main and tail rotors. Both sets of rotors are fitted with noise-attenuating blade tip caps that would decrease flyover noise.
The Society proposes to transport no more than 15 work crew members and equipment to Northwest Seal Rock for each session and estimates that each session would require no more than 36 helicopter landings/takeoffs per month. During landing, the helicopter would land on the caisson to allow the work crew members to disembark and retrieve their equipment located in a basket attached to the underside of the helicopter. The helicopter would then return to the mainland to pick up additional personnel and equipment.
Proposed schedule: The Society would conduct a maximum of 16 flights (eight arrivals and eight departures) for the first day. The first flight would depart from Crescent City Airport at approximately 9 a.m. for a 6-minute flight to Northwest Seal Rock. The helicopter would land and takeoff immediately after offloading personnel and equipment every 20 minutes (min). The total duration of the first day's aerial operations could last for approximately 3 hours (hrs) and 26 min and would end at approximately 12:34 p.m. Crew members would remain overnight at the Station and would not return to the mainland on the first day.
For the second day, the Society would conduct a maximum of 10 flights (five arrivals and five departures) to transport additional materials on and off the islet. The first flight would depart from Crescent City Airport at 9 a.m. for a 6-minute flight to Northwest Seal Rock. The total duration of the second day's aerial operations could last up to three hours.
For the final day of operations, the Society could conduct a maximum of eight helicopter flights (four arrivals and four departures) to transport the remaining crew members and equipment/material back to the Crescent City Airport. The total duration of the third day's helicopter operations in support of restoration could last up to 2 hrs and 14 min.
Restoration and maintenance activities would involve the removal of peeling paint and plaster, restoration of interior plaster and paint, refurbishing structural and decorative metal, reworking original metal support beams throughout the lantern room and elsewhere, replacing glass as necessary, upgrading the present electrical system; and annual light beacon maintenance.
The Society will need to conduct maintenance on the Station's beacon light at least once or up to two times per year within the proposed work window. Scheduled light maintenance activities would coincide with lighthouse restoration activities conducted monthly during the period of April 1 through April 30, 2014 and during the period of November 1, 2014, through March 31, 2015. The Society expects that maintenance activities would not exceed 3 hrs per each monthly session.
If the beacon light fails during the period from April 1 through April 30, 2014 or November 1, 2014 through March 31, 2015, the Society proposes to send a crew of two to three people to the Station by helicopter to repair the beacon light. For each emergency repair event, the Society proposes to conduct a maximum of four flights (two arrivals and two departures) to transport equipment and supplies. The helicopter may remain on site or transit back to shore and make a second landing to pick up the repair personnel.
In the case of an emergency repair between May 1, 2014, and October 31, 2014, the Society would consult with the NMFS' Western Regional Office (WRO) biologists to best determine the timing of the trips to the lighthouse, on a case-by-case basis, based upon the existing environmental conditions and
NMFS expects that acoustic stimuli resulting from the proposed helicopter operations; noise from maintenance and restoration activities; and human presence have the potential to harass marine mammals, incidental to the conduct of the proposed activities.
This section includes a brief explanation of the sound measurements frequently used in the discussions of acoustic effects in this notice. Sound pressure is the sound force per unit area, and is usually measured in micropascals (μPa), where 1 pascal (Pa) is the pressure resulting from a force of one newton exerted over an area of one square meter. Sound pressure level (SPL) is the ratio of a measured sound pressure and a reference level. The commonly used reference pressure is 1 μPa for under water, and the units for SPLs are dB re: 1 μPa. The commonly used reference pressure is 20 μPa for in air, and the units for SPLs are dB re: 20 μPa.
SPL (in decibels (dB)) = 20 log (pressure/reference pressure).
SPL is an instantaneous measurement expressed as the peak, the peak-peak (p-p), or the root mean square (rms). Root mean square is the square root of the arithmetic average of the squared instantaneous pressure values. All references to SPL in this document refer to the root mean square unless otherwise noted. SPL does not take into account the duration of a sound.
Noise testing performed on the R44 Raven Helicopter, as required for Federal Aviation Administration approval, required an overflight at 150 m (492 ft) above ground level, 109 knots and a maximum gross weight of 1,134 kg (2,500 lbs). The noise levels measured on the ground at this distance and speed were 81.9 decibels (dB) re: 20 μPa (A-weighted) for the model R44 Raven I, or 81.0 dB re: 20 μPa (A-weighted) for the model R44 Raven II (NMFS, 2007).
Based on this information, we expect that the received sound levels at the landing area on the Station's caisson would increase above 81-81.9 dB re: 20 μPa (A-weighted).
Any noise associated with these activities is likely to be from light construction (e.g., sanding, hammering, or use of hand drills). The Society proposes to confine all restoration activities to the existing structure which would occur on the upper levels of the Station. Pinnipeds hauled out on Northwest Seal Rock do not have access to the upper levels of the Station.
Table 1 provides the following: All marine mammal species with possible or confirmed occurrence in the proposed activity area; information on those species' regulatory status under the MMPA and the Endangered Species Act of 1973 (16 U.S.C. 1531 et seq.); abundance; occurrence and seasonality in the activity area.
There are several cetaceans that have the potential to transit in the vicinity of the lighthouse station including the short-beaked common (
California (southern) sea otters (
The marine mammals most likely to be harassed incidental to the Society's helicopter operations, lighthouse restoration, and lighthouse maintenance on Northwest Seal Rock are primarily Steller and California sea lions and to a lesser extent the Pacific harbor seal and the eastern Pacific stock of northern fur seal. We refer the public to Carretta
The California sea lion is now a full species, separated from the Galapagos sea lion (
California sea lion breeding areas are on islands located in southern California, in western Baja California, Mexico, and the Gulf of California. During the breeding season, most California sea lions inhabit southern California and Mexico. Rookery sites in southern California are limited to the San Miguel Islands and the southerly Channel Islands of San Nicolas, Santa Barbara, and San Clemente (Carretta
Adult and juvenile males will migrate as far north as British Columbia, Canada while females and pups remain in southern California waters in the non-breeding season. In warm water (El Niño) years, some females range as far north as Washington and Oregon, presumably following prey.
Crescent Coastal Research (CCR) conducted a three-year (1998-2000) survey of the wildlife species on NWSR for the Society. They reported that counts of California sea lions on NWSR varied greatly (from six to 541) during the observation period from April 1997 through July 2000. CCR reported that counts for California sea lions during the spring (April—May), summer (June-August), and fall (September-October), averaged 60, 154, and 235, respectively (CCR, 2001).
The most current counts for the month of July by NMFS (2000 through 2004) have been relatively low as the total number of California sea lions recorded in 2000 and 2003 was 3 and 11, respectively (M. Lowry, NMFS, SWFSC, unpublished data). Based on the monitoring report for the 2011 season, the maximum numbers of California sea lions present during the April and November, 2011 work sessions was 2 and 90 animals, respectively (SGRLPS, 2012). There were no California sea lions present during the March, 2012 work session (SGRLPS, 2012).
Northern fur seals occur from southern California north to the Bering Sea and west to the Sea of Okhotsk and Honshu Island of Japan. NMFS recognizes two separate stocks of northern fur seals within U.S. waters: An Eastern Pacific stock distributed among sites in Alaska, British Columbia; and a San Miguel Island stock distributed along the west coast of the continental U.S. The estimated population of the San Miguel Island stock is 9,968 animals with a maximum population growth rate of 12 percent (Carretta
Northern fur seals may temporarily haul out on land at other sites in Alaska, British Columbia, and on islets along the west coast of the continental United States, but generally this occurs outside of the breeding season (Fiscus, 1983).
Northern fur seals breed in Alaska and migrate along the west coast during fall and winter. Due to their pelagic habitat, they are rarely seen from shore in the continental U.S., but individuals occasionally come ashore on islands well offshore (i.e., Farallon Islands and Channel Islands in California). During the breeding season, approximately 74 percent of the worldwide population inhabits the Pribilof Islands in Alaska, with the remaining animals spread throughout the North Pacific Ocean (Lander and Kajimura, 1982).
CCR observed one male northern fur seal on Northwest Seal Rock in October, 1998 (CCR, 2001). It is possible that a few animals may use the island more often that indicated by the CCR surveys, if they were mistaken for other otariid species (i.e., eared seals or fur seals and sea lions) (M. DeAngelis, NMFS, pers. comm.).
For the 2010, 2011, and 2012 work seasons, the Society has not observed any northern fur seals present on Northwest Seal Rock during restoration activities (SGRLPS, 2010; 2011; 2012). The Society did not conduct any operations for the 2013 season.
The estimated population of the California stock of Pacific harbor seals is approximately 30,196 animals (Carretta
The animals inhabit near-shore coastal and estuarine areas from Baja California, Mexico, to the Pribilof Islands in Alaska. Pacific harbor seals consist of two subspecies:
In California, over 500 harbor seal haulout sites are widely distributed along the mainland and offshore islands, and include rocky shores, beaches and intertidal sandbars (Lowry
CCR noted that harbor seal use of Northwest Seal Rock was minimal, with only one sighting of a group of six animals, during 20 observation surveys. They hypothesized that harbor seals may avoid the islet because of its distance from shore, relatively steep topography, and full exposure to rough and frequently turbulent sea swells. For the 2010 and 2011 seasons, the Society did not observe any Pacific harbor seals present on Northwest Seal Rock during restoration activities (SGRLPS, 2010; 2011). During the 2012 season, the Society reported sighting a total of two harbor seals present on Northwest Seal Rock (SGRLPS, 2012). The Society did not conduct any operations for the 2013 season.
Steller sea lions consist of two distinct population segments: the western and eastern distinct population segments (DPS) divided at 144° West longitude (Cape Suckling, Alaska). The western segment of Steller sea lions inhabit central and western Gulf of Alaska, Aleutian Islands, as well as coastal waters and breed in Asia (e.g., Japan and Russia). The eastern segment includes sea lions living in southeast Alaska, British Columbia, California, and Oregon.
Steller sea lions range along the North Pacific Rim from northern Japan to California (Loughlin
In 2012, the estimated population of the eastern distinct population segment ranged from a minimum of 58,334 up to 72,223 animals and the maximum population growth rate is 12 percent (Allen and Angliss, 2013). On October 23, 2013 NMFS announced the removal of the eastern distinct population segment of Steller sea lions from the list of threatened species under the ESA. As of December 4, 2013 the eastern DPS is not a threatened species listed under the ESA. With the delisting, federal agencies proposing actions that may affect the eastern Steller sea lions are no longer required to consult with NMFS under section 7 of the ESA.
The eastern distinct population segment of Steller sea lions breeds on rookeries located in southeast Alaska, British Columbia, Oregon, and California. There are no rookeries located in Washington state. Steller sea lions give birth in May through July and breeding commences a couple of weeks after birth. Pups are weaned during the winter and spring of the following year.
Despite the wide-ranging movements of juveniles and adult males in particular, exchange between rookeries by breeding adult females and males (other than between adjoining rookeries) appears low, although males have a higher tendency to disperse than females (NMFS, 1995; Trujillo
CCR reported that Steller sea lion numbers at Northwest Seal Rock ranged from 20 to 355 animals. Counts of Steller sea lions during the spring (April—May), summer (June-August), and fall (September-October), averaged 68, 110, and 56, respectively (CCR, 2001). A more recent survey at NWSR between 2000 and 2004 showed Steller sea lion numbers ranged from 175 to 354 in July (M. Lowry, NMFS/SWFSC, unpubl. data). The Society presumes that winter use of NWSR by Steller sea lion to be minimal, due to inundation of the natural portion of the island by large swells.
For the 2010 season, the Society reported that no Steller sea lions were present in the vicinity of Northwest Seal Rock during restoration activities (SGRLPS, 2010). Based on the monitoring report for the 2011 season, the maximum numbers of Steller sea lions present during the April and November 2011, work sessions was 2 and 150 animals, respectively (SGRLPS, 2012). During the 2012 season, the Society did not observe any Steller sea lions present on Northwest Seal Rock during restoration activities. The Society did not conduct any operations for the 2013 season.
This section includes a summary and discussion of the ways that the types of stressors associated with the specified activity (e.g., aircraft operations and human presence) have the potential to impact marine mammals. This discussion may also include reactions that we consider to rise to the level of a take and those that we do not consider to rise to the level of a take (e.g., with acoustics, we may include a discussion of studies that show animals not reacting to sound or animals exhibiting barely perceptible avoidance behaviors). We also intend this section to provide a background of potential effects of the Society's activities. This section does not consider the specific manner in which the Society would carry out the proposed activity, what mitigation measures the Society would implement, and how either of those would shape the anticipated impacts from this specific activity. The “Estimated Take by Incidental Harassment” section later in this document will include a quantitative analysis of the number of individuals that we expect the Society to take during this activity. The “Negligible Impact Analysis” section will include the analysis of how this specific activity would impact marine mammals. We will consider the content of the following sections: (1) Negligible Impact Analysis; (2) Estimated Take by Incidental Harassment; (3) Proposed Mitigation; and (4) Anticipated Effects on Marine Mammal Habitat, to draw conclusions regarding the likely impacts of the Society's activities on the reproductive success or survivorship of individuals—and from that consideration—the likely impacts of this activity on the affected marine mammal populations or stocks.
Acoustic and visual stimuli generated by: (1) Helicopter landings/takeoffs; (2) noise generated during restoration activities (e.g., painting, plastering, welding, and glazing); and (3) maintenance activities (e.g., bulb replacement and automation of the light system) may have the potential to cause the following: temporary or permanent hearing impairment and/or behavioral disturbance (Southall,
When considering the influence of various kinds of sound on the marine environment, it is necessary to understand that different kinds of marine life are sensitive to different frequencies of sound and current data indicate that not all marine mammal species have equal hearing capabilities (Richardson
The functional groups and the associated frequencies are:
• Low frequency cetaceans (13 species of mysticetes): functional hearing estimates occur between approximately 7 Hertz (Hz) and 30 kHz (extended from 22 kHz based on data indicating that some mysticetes can hear above 22 kHz; Au
• Mid-frequency cetaceans (32 species of dolphins, six species of larger toothed whales, and 19 species of beaked and bottlenose whales): functional hearing estimates occur between approximately 150 Hz and 160 kHz;
• High-frequency cetaceans (eight species of true porpoises, six species of river dolphins,
• Pinnipeds in water: functional hearing estimates occur between approximately 75 Hz and 100 kHz, with the greatest sensitivity between approximately 700 Hz and 20 kHz.
As mentioned previously in this document, four marine mammal species would likely occur in the proposed action area. All are pinnipeds and fall under the Pinnipeds in water functional hearing group category. We consider a species' functional hearing group when we analyze the effects of exposure to sound on marine mammals.
Marine mammals produce sounds in various important contexts—social interactions, foraging, navigating, and to responding to predators. The best available science suggests that pinnipeds have a functional aerial hearing sensitivity between 75 hertz (Hz) and 75 kilohertz (kHz) and can produce a diversity of sounds, though generally from 100 Hz to several tens of kHz (Southall,
Exposure to high intensity sound for a sufficient duration may result in auditory effects such as a noise-induced threshold shift—an increase in the auditory threshold after exposure to noise (Finneran, Carder, Schlundt, and Ridgway, 2005). Factors that influence the amount of threshold shift include the amplitude, duration, frequency content, temporal pattern, and energy distribution of noise exposure. The magnitude of hearing threshold shift normally decreases over time following cessation of the noise exposure. The amount of threshold shift just after exposure is called the initial threshold shift. If the threshold shift eventually returns to zero (i.e., the threshold returns to the pre-exposure value), it is called temporary threshold shift (TTS) (Southall
Pinnipeds have the potential to be disturbed by airborne and underwater noise generated by the engine of the aircraft (Born, Riget, Dietz, & Andriashek, 1999; Richardson, Greene, Malme, & Thomson, 1995). Data on underwater TTS-onset in pinnipeds exposed to pulses are limited to a single study which exposed two California sea lions to single underwater pulses from an arc-gap transducer and found no measurable TTS following exposures up to 183 dB re: 1 μPa (peak-to-peak) (Finneran, Dear, Carder, & Ridgway, 2003).
Researchers have demonstrated TTS in certain captive odontocetes and pinnipeds exposed to strong sounds (reviewed in Southall
There is a dearth of information on acoustic effects of helicopter overflights on pinniped hearing and communication (Richardson, et al., 1995) and to NMFS' knowledge, there has been no specific documentation of TTS, let alone permanent threshold shift (PTS), in free-ranging pinnipeds exposed to helicopter operations during realistic field conditions (Baker, Jensz, & Chilvers, 2012; Scheidat
In 2008, we issued an Authorization to the USFWS for the take of small numbers of Steller sea lions and Pacific harbor seals, incidental to rodent eradication activities on an islet offshore of Rat Island, AK conducted by helicopter. The 15-minute aerial treatment consisted of the helicopter slowly approaching the islet at an elevation of over 1,000 feet (304.8 m); gradually decreasing altitude in slow circles; and applying the rodenticide in a single pass and returning to Rat Island. The gradual and deliberate approach to the islet resulted in the sea lions present initially becoming aware of the helicopter and calmly moving into the water. Further, the USFWS reported that all responses fell well within the range of Level B harassment (i.e., alert head raises without moving or limited, short-term displacement resulting from aircraft noise due to helicopter overflights).
As a general statement from the available information, pinnipeds exposed to intense (approximately 110 to 120 dB re: 20 μPa) non-pulse sounds often leave haulout areas and seek refuge temporarily (minutes to a few hours) in the water (Southall
There is increasing recognition that the effect of human disturbance wildlife is highly dependent on the nature of the disturbance (Burger
The Hawaiian monk seal (
It is likely that the initial helicopter approach to the Station would cause a subset, or all of the marine mammals hauled out on NWSR to depart the rock and flush into the water. The physical presence of aircraft could also lead to non-auditory effects on marine mammals involving visual or other cues. Airborne sound from a low-flying helicopter or airplane may be heard by marine mammals while at the surface or underwater. In general, helicopters tend to be noisier than fixed wing aircraft of similar size and underwater sounds from aircraft are strongest just below the surface and directly under the aircraft. Noise from aircraft would not be expected to cause direct physical effects but have the potential to affect behavior. The primary factor that may influence abrupt movements of animals is engine noise, specifically changes in engine noise. Responses by mammals could include hasty dives or turns, change in course, or flushing and stampeding from a haul out site. There are few well documented studies of the impacts of aircraft overflight over pinniped haul out sites or rookeries, and many of those that exist, are specific to military activities (Efroymson
Several factors complicate the analysis of long- and short-term effects for aircraft overflights. Information on behavioral effects of overflights by military aircraft (or component stressors) on most wildlife species is sparse. Moreover, models that relate behavioral changes to abundance or reproduction, and those that relate behavioral or hearing effects thresholds from one population to another are generally not available. In addition, the aggregation of sound frequencies, durations, and the view of the aircraft into a single exposure metric is not always the best predictor of effects and it may also be difficult to calculate. Overall, there has been no indication that single or occasional aircraft flying above pinnipeds in water cause long term displacement of these animals (Richardson
If pinnipeds are present on NWSR, it is likely that a helicopter landing at the Station would cause some number of the pinnipeds on NWSR to flush; however, when present, they appear to show rapid habituation to helicopter landing and departure (Crescent Coastal Research, 2001; Guy Towers, SGRLPS, pers. com.). According to the CCR Report (2001), while up to 40 percent of the California and Steller sea lions present on the rock have been observed to enter the water on the first of a series of helicopter landings, as few as zero percent have flushed on subsequent landings on the same date. In fact, the Society reported that during the November 2011 work session, Steller sea lions and California sea lions exhibited minimal ingress and egress from Northwest Seal Rock during helicopter approaches and departures (SGRLPS, 2011).
If pinnipeds are present on NWSR, Level B behavioral harassment of pinnipeds may occur during helicopter landing and takeoff from NWSR due to the pinnipeds temporarily moving from the rocks and lower structure of the Station into the sea due to the noise and appearance of helicopter during approaches and departures. It is expected that all or a portion of the marine mammals hauled out on the island will depart the rock and move into the water upon initial helicopter approaches. The movement to the water would be gradual due to the required controlled helicopter approaches (see Proposed Mitigation section), the small size of the aircraft, the use of noise-attenuating blade tip caps on the rotors, and behavioral habituation on the part of the animals as helicopter trips continue throughout the day. During the sessions of helicopter activity, if present on NWSR, some animals may be temporarily displaced from the island and either raft in the water or relocate to other haul-outs.
Sea lions have shown habituation to helicopter flights within a day at the project site and most animals are expected to return soon after helicopter activities cease for that day. By clustering helicopter arrival/departures within a short time period, we expect animals present to show less response to subsequent landings. We anticipate no impact on the population size or breeding stock of Steller sea lions, California sea lions, Pacific harbor seals, or northern fur seals.
Restoration and maintenance activities would involve the removal of peeling paint and plaster, restoration of interior plaster and paint, refurbishing structural and decorative metal, reworking original metal support beams throughout the lantern room and elsewhere, replacing glass as necessary, upgrading the present electrical system; and annual light beacon maintenance. Any noise associated with these activities is likely to be from light construction (e.g., sanding, hammering, or use of hand drills) and the pinnipeds may be disturbed by human presence. Animals respond to disturbance from humans in the same way as they respond to the risk of predation, by avoiding areas of high risk, either completely or by using them for limited periods (Gill
Sudden movement of large numbers of animals may cause a stampede. In order to prevent such stampedes from occurring within the sea lion colony, we would require certain mitigation requirements and restrictions, such as controlled helicopter approaches and limited access period during the pupping season, should we issue an Authorization. As such, and because any pinnipeds nearby likely would avoid the approaching helicopter, the Society anticipates that there will be no instances of injury or mortality during the proposed project.
NMFS does not expect that the proposed activity would have any effects on marine mammal habitat. Based on previous monitoring reports and anecdotal observations, up to 315 animals could use the small, rocky base at the base of the Station as a haulout site. The Society proposes to confine all restoration activities to the existing structure which would occur on the upper levels of the Station which are not used by marine mammals. Thus, NMFS expects that there will be no long- or short-term physical impacts to pinniped habitat on NWSR.
The Society would remove all waste, discarded materials and equipment from the island after each visit. The proposed activities will not result in any permanent impact on habitats used by marine mammals, including prey species and foraging habitat. The main impact associated with the proposed activity will be temporarily elevated noise levels and the associated direct effects on marine mammals (i.e., the potential for temporary abandonment of the site), previously discussed in this notice.
In order to issue an incidental take authorization under section 101(a)(5)(D) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to such activity, and other means of effecting the least practicable adverse impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for taking for certain subsistence uses (where relevant).
As a way to reduce or minimize adverse impacts that would result from the proposed project to the lowest level practicable, NMFS proposes to require the following mitigation measures.
Since the most severe impacts (stampede) precede rapid and direct helicopter approaches, the Society's initial approach to the Station must be offshore from the island at a relatively high altitude (e.g., 800-1,000 ft, or 244-305 m). Before the final approach, the helicopter shall circle lower, and approach from area with the lowest pinniped density. If for any safety reasons (e.g., wind condition) the Society cannot conduct these types of helicopter approach and timing techniques, they must abort the restoration and maintenance activities for that day.
NMFS has carefully evaluated the Society's proposed mitigation measures in the context of ensuring that we prescribe the means of effecting the least practicable impact on the affected marine mammal species and stocks and their habitat. Our evaluation of potential measures included consideration of the following factors in relation to one another:
• The manner in which, and the degree to which, the successful implementation of the measure is expected to minimize adverse impacts to marine mammals;
• The proven or likely efficacy of the specific measure to minimize adverse impacts as planned; and
• The practicability of the measure for applicant implementation.
Any mitigation measure(s) prescribed by us should be able to accomplish, have a reasonable likelihood of accomplishing (based on current science), or contribute to the accomplishment of one or more of the general goals listed here:
1. Avoidance or minimization of injury or death of marine mammals wherever possible (goals 2, 3, and 4 may contribute to this goal).
2. A reduction in the numbers of marine mammals (total number or number at biologically important time or location) exposed to helicopter operations and human presence that we expect to result in the take of marine mammals (this goal may contribute to 1, above, or to reducing harassment takes only).
3. A reduction in the number of times (total number or number at biologically important time or location) individuals would be exposed to helicopter operations or human presence that we expect to result in the take of marine mammals (this goal may contribute to 1, above, or to reducing harassment takes only).
4. A reduction in the intensity of exposures (either total number or number at biologically important time or location) to to helicopter operations or human presence that we expect to result in the take of marine mammals (this goal may contribute to a, above, or to reducing the severity of harassment takes only).
5. Avoidance or minimization of adverse effects to marine mammal habitat, paying special attention to the food base, activities that block or limit passage to or from biologically important areas, permanent destruction of habitat, or temporary destruction/disturbance of habitat during a biologically important time.
6. For monitoring directly related to mitigation—an increase in the probability of detecting marine mammals, thus allowing for more effective implementation of the mitigation.
Based on the evaluation of the Society's proposed measures, as well as other measures considered by us, NMFS preliminarily determined that the proposed mitigation measures provide the means of effecting the least practicable impact on marine mammal species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.
The Society complied with the mitigation and monitoring required under the previous authorizations (2010-2013). They did not conduct any operations for the 2013 season. However, in compliance with the 2012 Authorization, the Society submitted a final report on the activities at the Station, covering the period of February 15, 2012 through April 30, 2012. During the effective dates of the 2012 IHA, the Society conducted one work session in March, 2012. The Society's aircraft operations and restoration activities on NWSR did not exceed the activity levels analyzed under the 2012 authorization. During the March 2012 work session, the Society observed two harbor seals hauled out on Northwest Seal Rock. Both animals (a juvenile and an adult) departed the rock, entered the water, and did not return to the Station during the duration of the activities.
In order to issue an ITA for an activity, section 101(a)(5)(D) of the MMPA states that NMFS must set forth “requirements pertaining to the monitoring and reporting of such taking”. The MMPA implementing regulations at 50 CFR 216.104 (a)(13) indicate that requests for Authorizations must include the suggested means of accomplishing the necessary monitoring
Monitoring measures prescribed by us should accomplish one or more of the following general goals:
1. An increase in the probability of detecting marine mammals, both within the mitigation zone (thus allowing for more effective implementation of the mitigation) and during other times and locations, in order to generate more data to contribute to the analyses mentioned later;
2. An increase in our understanding of how many marine mammals would be affected by helicopter operations and human presence and the likelihood of associating those exposures with specific adverse effects, such as behavioral harassment, temporary or permanent threshold shift;
3. An increase in our understanding of how marine mammals respond to stimuli that we expect to result in take and how those anticipated adverse effects on individuals (in different ways and to varying degrees) may impact the population, species, or stock (specifically through effects on annual rates of recruitment or survival) through any of the following methods:
a. Behavioral observations in the presence of stimuli compared to observations in the absence of stimuli (i.e., we need to be able to accurately predict received level, distance from source, and other pertinent information);
b. Physiological measurements in the presence of stimuli compared to observations in the absence of stimuli (i.e., we need to be able to accurately predict received level, distance from source, and other pertinent information);
c. Distribution and/or abundance comparisons in times or areas with concentrated stimuli versus times or areas without stimuli;
4. An increased knowledge of the affected species; and
5. An increase in our understanding of the effectiveness of certain mitigation and monitoring measures.
Aerial photographic surveys may provide the most accurate means of documenting species composition, age and sex class of pinnipeds using the project site during human activity periods. The Society should complete aerial photo coverage of the island from the same helicopter used to transport the Society's personnel to the island during restoration trips. The Society would take photographs of all marine mammals hauled out on the island at an altitude greater than 300 m (984 ft) by a skilled photographer, prior to the first landing on each visit included in the monitoring program. Photographic documentation of marine mammals present at the end of each three-day work session shall also be made for a before and after comparison. These photographs will be forwarded to a biologist capable of discerning marine mammal species. Data shall be provided to us in the form of a report with a data table, any other significant observations related to marine mammals, and a report of restoration activities (see Reporting). The original photographs can be made available to us or other marine mammal experts for inspection and further analysis.
The Society will submit a draft Monitoring Report to us no later than 90 days after they complete the project to the NMFS Director of Office of Protected Resources. Within 30 days after receiving comments from us on the draft Final Monitoring Report, the Society must submit a Final Monitoring Report to the NMFS Director of Office of Protected Resources. If the Society receives no comments from us on the draft Monitoring Report, then NMFS will consider the draft Monitoring Report to be the Final Monitoring Report.
The final report will provide:
(i) A summary and table of the dates, times, and weather during all helicopter operations, and restoration and maintenance activities.
(ii) Species, number, location, and behavior of any marine mammals, observed throughout all monitoring activities.
(iii) An estimate of the number (by species) of marine mammals that are known to have been exposed to acoustic stimuli associated with the helicopter operations, restoration and maintenance activities.
(iv) A description of the implementation and effectiveness of the monitoring and mitigation measures of the IHA and full documentation of methods, results, and interpretation pertaining to all monitoring.
In the unanticipated event that the specified activity clearly causes the take of a marine mammal in a manner prohibited by the authorization (if issued), such as an injury (Level A harassment), serious injury, or mortality (e.g., vessel-strike, stampede, etc.), the Society shall immediately cease the specified activities and immediately report the incident to the Incidental Take Program Supervisor, Permits and Conservation Division, Office of Protected Resources, NMFS, at 301-427-8401 and/or by email to
• Time, date, and location (latitude/longitude) of the incident;
• Description and location of the incident (including water depth, if applicable);
• Environmental conditions (e.g., wind speed and direction, Beaufort sea state, cloud cover, and visibility);
• Description of all marine mammal observations in the 24 hours preceding the incident;
• Species identification or description of the animal(s) involved;
• Fate of the animal(s); and
• Photographs or video footage of the animal(s) (if equipment is available).
The Society shall not resume its activities until NMFS is able to review the circumstances of the prohibited take. NMFS shall work with the Society to determine what is necessary to minimize the likelihood of further prohibited take and ensure Marine Mammal Protection Act compliance. The Society may not resume their activities until notified by us via letter, email, or telephone.
In the event that the Society discovers an injured or dead marine mammal, and the lead visual observer determines that the cause of the injury or death is unknown and the death is relatively recent (i.e., in less than a moderate state of decomposition as we describe in the next paragraph), the Society will immediately report the incident to the Incidental Take Program Supervisor, Permits and Conservation Division, Office of Protected Resources, at 301-427-8401 and/or by email to
In the event that the Society discovers an injured or dead marine mammal, and the lead visual observer determines that the injury or death is not associated with or related to the authorized activities (e.g., previously wounded animal, carcass with moderate to advanced decomposition, or scavenger damage), the Society will report the incident to the Incidental Take Program Supervisor, Permits and Conservation Division, Office of Protected Resources, at 301-427-8401 and/or by email to
Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as:
NMFS anticipates that the helicopter operations and restoration and maintenance activities have the potential to harass (Level B only) marine mammals that may be present on NWSR. Thus NMFS will only authorize take by Level B harassment as a result of the helicopter operations and restoration and maintenance activities on NWSR.
Based on pinniped survey counts conducted by CCR on NWSR in the spring of 1997, 1998, 1999, and 2000 (CCR, 2001), NMFS estimates that approximately 204 California sea lions (calculated by multiplying the average monthly abundance of California sea lions (zero in April, 1997 and 34 in April, 1998) present on NWSR by 6 months of the restoration and maintenance activities), 172 Steller sea lions (NMFS' estimate of the maximum number of Steller sea lions that could be present on NWSR with a 95-percent confidence interval), 36 Pacific harbor seals (calculated by multiplying the maximum number of harbor seals present on NWSR (6) by 6 months), and 6 northern fur seals (calculated by multiplying the maximum number of northern fur seals present on NWSR (1) by 6 months) could be potentially affected by Level B behavioral harassment over the course of the Authorization. NMFS bases these estimates of the numbers of marine mammals that might be affected on consideration of the number of marine mammals that could be disturbed appreciably by approximately 51 hours of aircraft operations during the course of the activity. These incidental harassment take numbers represent approximately 0.14 percent of the U.S. stock of California sea lion, 0.42 percent of the eastern U.S. stock of Steller sea lion, 0.11 percent of the California stock of Pacific harbor seals, and 0.06 percent of the San Miguel Island stock of northern fur seal. Because of the required mitigation measures and the likelihood that some pinnipeds will avoid the area, NMFS does not expect any injury or mortality to pinnipeds to occur and NMFS has not authorized take by Level A harassment for this proposed activity.
The Society will continue to coordinate monitoring of pinnipeds during the helicopter operations and restoration activities which contribute to the basic knowledge of marine mammal biology on NWSR.
Negligible impact is “an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival” (50 CFR 216.103). The lack of likely adverse effects on annual rates of recruitment or survival (i.e., population level effects) forms the basis of a negligible impact finding. Thus, an estimate of the number of Level B harassment takes, alone, is not enough information on which to base an impact determination. In addition to considering estimates of the number of marine mammals that might be “taken” through behavioral harassment, NMFS must consider other factors, such as the likely nature of any responses (their intensity, duration, etc.), the context of any responses (critical reproductive time or location, migration, etc.), as well as the number and nature of estimated Level A harassment takes, and the number of estimated mortalities, and effects on habitat.
In making a negligible impact determination, NMFS considers:
• The number of anticipated injuries, serious injuries, or mortalities;
• The number, nature, and intensity, and duration of Level B harassment; and
• The context in which the takes occur (e.g., impacts to areas of significance, impacts to local populations, and cumulative impacts when taking into account successive/contemporaneous actions when added to baseline data);
• The status of stock or species of marine mammals (i.e., depleted, not depleted, decreasing, increasing, stable, impact relative to the size of the population);
• Impacts on habitat affecting rates of recruitment/survival; and
• The effectiveness of monitoring and mitigation measures.
For reasons stated previously in this document and based on the following factors, the Society's specified activities are not likely to cause long-term behavioral disturbance, abandonment of the haulout area, injury, serious injury, or mortality because:
(1) The effects of the Society's operations would be limited to no responses, short-term startle responses, or temporary behavioral changes due to the short and sporadic duration of the restoration activities. Minor and brief responses, such as short-duration startle or alert reactions, are not likely to constitute disruption of behavioral patterns, such as migration, nursing, breeding, feeding, or sheltering.
(2) The availability of alternate areas for pinnipeds to avoid the resultant acoustic and visual disturbances from the restoration activities and helicopter operations. Results from previous monitoring reports also show that the pinnipeds returned to the various sites and did not permanently abandon haul-out sites after the Society conducted their activities.
(3) There is no potential for large-scale movements leading to injury, serious injury, or mortality because the Society must delay ingress onto NWSR until after the pinnipeds present have slowly entered the water.
NMFS does not anticipate that any injuries, serious injuries, or mortalities would occur as a result of the Society's proposed activities, and NMFS does not propose to authorize injury, serious injury or mortality. These species may exhibit behavioral modifications, including temporarily vacating the area during the proposed helicopter operations and restoration activities to avoid the resultant acoustic and visual
Based on this notice's analysis of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the proposed monitoring and mitigation measures, NMFS preliminarily finds that the Society's proposed helicopter operations and restoration/maintenance activities would have a negligible impact on the affected marine mammal species or stocks.
As mentioned previously, NMFS estimates that the Society's activities could potentially affect, by Level B harassment only, four species of marine mammals under our jurisdiction. For each species, these estimates are small numbers (each, less than or equal to one percent) relative to the population size. These incidental harassment take numbers represent approximately 0.14 percent of the U.S. stock of California sea lion, 0.42 percent of the eastern U.S. stock of Steller sea lion, 0.11 percent of the California stock of Pacific harbor seals, and 0.06 percent of the San Miguel Island stock of northern fur seal. Because of the required mitigation measures and the likelihood that some pinnipeds will avoid the area, no injury or mortality to pinnipeds is expected nor requested. The proposed taking would be limited to small numbers of marine mammals, relative to the population sizes of the affected species or stocks (i.e., for each species, these numbers are less than one percent).
Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the mitigation and monitoring measures, NMFS preliminarily finds that the Society's proposed helicopter operations and restoration/maintenance activities would take small numbers of marine mammals relative to the populations of the affected species or stocks.
There are no relevant subsistence uses of marine mammals implicated by this action.
NMFS does not expect that the Society's proposed helicopter operations and restoration/maintenance activities would affect any species listed under the ESA. Therefore, NMFS has determined that a section 7 consultation under the ESA is not required.
To meet our NEPA requirements for the issuance of an Authorization to the Society, NMFS has prepared an Environmental Assessment (EA) in 2010 that was specific to conducting aircraft operations and restoration and maintenance work on the St. George Reef Light Station. The EA, titled “Issuance of an Incidental Harassment Authorization to Take Marine Mammals by Harassment Incidental to Conducting Aircraft Operations, Lighthouse Restoration and Maintenance Activities on St. George Reef Lighthouse Station in Del Norte County, California,” evaluated the impacts on the human environment of our authorization of incidental Level B harassment resulting from the specified activity in the specified geographic region. At that time, NMFS concluded that issuance of an annual Authorization would not significantly affect the quality of the human environment and issued a Finding of No Significant Impact (FONSI) for the 2010 EA regarding the Society's activities. In conjunction with the Society's 2014 application, NMFS has again reviewed the 2010 EA and determined that there are no new direct, indirect or cumulative impacts to the human and natural environment associated with the IHA requiring evaluation in a supplemental EA and NMFS, therefore, intends to preliminarily reaffirm the 2010 FONSI. An electronic copy of the EA and the FONSI for this activity is available upon request (see
As a result of these preliminary determinations, NMFS proposes issuing an Authorization to the Society for conducting helicopter operations and restoration activities on the St. George Light Station in the northeast Pacific Ocean, April 1 through April 30, 2014 and November 1, 2014, through March 31, 2015, provided they incorporate the previously mentioned mitigation, monitoring, and reporting requirements.
The St. George Reef Lighthouse Preservation Society (Society), P.O. Box 577, Crescent City, CA 95531, is hereby authorized under section 101(a)(5)(D) of the Marine Mammal Protection Act (16 U.S.C. 1371(a)(5)(D)) and 50 CFR 216.107, to harass marine mammals incidental to conducting helicopter operations and restoration and maintenance work on the St. George Reef Light Station (Station) on Northwest Seal Rock in the northeast Pacific Ocean.
1. This Incidental Harassment Authorization (IHA) is valid from April 1 through April 30, 2014 and November 1, 2014, through March 31, 2015.
2. This IHA is valid only for activities associated with helicopter operations and restoration and maintenance activities (See items 2(a)-(d)) on the Station on Northwest Seal Rock (41°50′24″ N, 124°22′06″ W) in the northeast Pacific Ocean.
a. The use of a small, compact, 4-person helicopter with two-bladed main and tail rotors fitted with noise-attenuating blade tip caps to transit to and from Northwest Seal Rock;
b. restoration activities (e.g., painting, plastering, welding, and glazing) conducted on the Station;
c. maintenance activities (e.g., bulb replacement and automation of the light system) conducted on the Station; and
d. emergency repair events (e.g., the failure of the PATON beacon light) between April 1 through April 30, 2014 and November 1, 2014, through March 31, 2015, outside of the three-day work session.
a. A copy of this IHA must be in the possession of the Society, its designees, and work crew personnel operating under the authority of this IHA.
b. The species authorized for taking are the California sea lion (
c. The taking, by Level B harassment only, is limited to the species listed in condition 3(b) (See Table 1 for take numbers, attached).
d. The taking by Level A harassment, injury or death of any of the species listed in item 3(b) of the Authorization or the taking by harassment, injury or death of any other species of marine mammal is prohibited and may result in the modification, suspension, or revocation of this IHA.
e. In the case of an emergency repair event (
a. The Western Region NMFS marine mammal biologist will make a decision regarding when the Society can schedule helicopter trips to the Northwest Seal Rock during the emergency repair time window and will ensure that such operations will have the least practicable adverse impact to marine mammals.
b. The ARA, Western Region, NMFS will also ensure that the Society's request for incidental take during an emergency repair event would not exceed the number of incidental take authorized in this IHA.
The holder of this Authorization is required to cooperate with the NMFS and any other Federal, state, or local agency authorized to monitor the impacts of the activity on marine mammals.
In order to ensure the least practicable impact on the species listed in condition 3(b), the holder of this Authorization is required to:
a. Conduct restoration and maintenance activities at the Station at a maximum of one session per month between April 1 through April 30, 2014 and November 1, 2014, through March 31, 2015. Each restoration session will be no more than three days in duration. Maintenance of the light beacon will occur only in conjunction with the monthly restoration activities.
b. Ensure that helicopter approach patterns to the Northwest Seal Rock will be such that the timing techniques are least disturbing to marine mammals. To the extent possible, the helicopter should approach Northwest Seal Rock when the tide is too high for the marine mammals to haul-out on Northwest Seal Rock.
c. Avoid rapid and direct approaches by the helicopter to the station by approaching Northwest Seal Rock at a relatively high altitude (e.g., 800-1,000 ft; 244-305 m). Before the final approach, the helicopter shall circle lower, and approach from area where the density of pinnipeds is the lowest. If for any safety reasons (e.g., wind conditions or visibility) such helicopter approach and timing techniques cannot be achieved, the Society must abort the restoration and maintenance session for that day.
d. Provide instructions to the Society's members, the restoration crew, and if applicable, to tourists, on appropriate conduct when in the vicinity of hauled-out marine mammals. The Society's members, the restoration crew, and if applicable, tourists, will avoid making unnecessary noise while on Northwest Seal Rock and must not view pinnipeds around the base of the Station.
e. Ensure that the door to the Station's lower platform shall remain closed and barricaded at all times.
The holder of this Authorization is required to:
a. Have a NMFS-approved biologist present during all three workdays at the Station at least once during the period between April 1 through April 30, 2014 and November 1, 2014, through March 31, 2015. This requirement may be modified depending on the results of the monthly monitoring reports. The biologist shall document use of the island by the marine mammals (i.e., dates, time, tidal height, species, numbers present, frequency of use, weather conditions, and any disturbances), and note any responses to potential disturbances.
b. Record the date, time, and location (or closest point of ingress) of each visit to the Northwest Seal Rock. See Table 2 for an example of a data collection sheet.
c. Collect the following information for each visit:
i. Information on the numbers (by species) of marine mammals observed during the activities;
ii. the estimated number of marine mammals (by species) that may have been harassed during the activities;
iii. any behavioral responses or modifications of behaviors that may be attributed to the specific activities (e.g., flushing into water, becoming alert and moving, rafting); and
iv. information on the weather, including the tidal state and horizontal visibility.
d. Employ a skilled, aerial photographer to document marine mammals hauled out on Northwest Seal Rock for comparing marine mammal presence on Northwest Seal Rock pre- and post-restoration.
i. The photographer will complete a photographic survey of Northwest Seal Rock using the same helicopter that will transport Society personnel to the island during restoration trips.
ii. For a pre-restoration survey, photographs of all marine mammals hauled-out on the island shall be taken at an altitude greater than 300 m (984 ft) during the first arrival flight to Northwest Seal Rock.
iii. For the post-restoration survey, photographs of all marine mammals hauled-out on the island shall be taken at an altitude greater than 300 m (984 ft) during the last departure flight from Northwest Seal Rock;
iv. The Society and/or its designees will forward the photographs to a biologist capable of discerning marine mammal species. The Society shall provide the data to us in the form of a report with a data table, any other significant observations related to marine mammals, and a report of restoration activities (see Reporting). The Society will make available the original photographs to NMFS or to other marine mammal experts for inspection and further analysis.
Final Report: The holder of this authorization is required to submit a draft monitoring report to the Chief, Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East West Highway, 13th Floor, Silver Spring, MD 20910; phone (301) 427-8401 no later than 90 days after the project is completed. The report must contain the following information:
a. A summary of the dates, times, and weather during all helicopter operations, restoration, and maintenance activities.
b. Species, number, location, and behavior of any marine mammals, observed throughout all monitoring activities.
c. An estimate of the number (by species) of marine mammals that are known to have been exposed to visual and acoustic stimuli associated with the helicopter operations, restoration, and maintenance activities.
d. A description of the implementation and effectiveness of the monitoring and mitigation measures of the IHA and full documentation of methods, results, and interpretation pertaining to all monitoring.
In the unanticipated event that the specified activity clearly causes the take of a marine mammal in a manner prohibited by the authorization (if issued), such as an injury (Level A harassment), serious injury, or mortality (e.g., vessel-strike, stampede, etc.), the Society shall immediately cease the specified activities and immediately report the incident to the Incidental Take Program Supervisor, Permits and Conservation Division, Office of Protected Resources, NMFS, at 301-427-8401 and/or by email to
The report must include the following information:
• Time, date, and location (latitude/longitude) of the incident;
• Name and type of vessel involved;
• Vessel's speed during and leading up to the incident;
• Description of the incident;
• Status of all sound source use in the 24 hours preceding the incident;
• Water depth;
• Environmental conditions (
• Description of all marine mammal observations in the 24 hours preceding the incident;
• Species identification or description of the animal(s) involved;
• Fate of the animal(s); and
• Photographs or video footage of the animal(s) (if equipment is available).
The Society shall not resume its activities until we are able to review the circumstances of the prohibited take. We shall work with the Society to determine what is necessary to minimize the likelihood of further prohibited take and ensure Marine Mammal Protection Act compliance. The Society may not resume their activities until notified by us via letter, email, or telephone.
In the event that the Society discovers an injured or dead marine mammal, and the lead visual observer determines that the cause of the injury or death is unknown and the death is relatively recent (i.e., in less than a moderate state of decomposition as we describe in the next paragraph), the Society will immediately report the incident to the Incidental Take Program Supervisor, Permits and Conservation Division, Office of Protected Resources, at 301-427-8401 and/or by email to
The report must include the same information identified in the paragraph above. Activities may continue while we review the circumstances of the incident. We will work with the Society to determine whether modifications in the activities are appropriate.
In the event that the Society discovers an injured or dead marine mammal, and the lead visual observer determines that the injury or death is not associated with or related to the authorized activities (e.g., previously wounded animal, carcass with moderate to advanced decomposition, or scavenger damage), the Society will report the incident to the Incidental Take Program Supervisor, Permits and Conservation Division, Office of Protected Resources, at 301-427-8401 and/or by email to
The Society's staff will provide photographs or video footage (if available) or other documentation of the stranded animal sighting to us.
11. This Authorization may be modified, suspended or withdrawn if the holder fails to abide by the conditions prescribed herein, or if the authorized taking is having a more than a negligible impact on the species or stock of affected marine mammals.
We request comments on our analysis, the draft authorization, and any other aspect of this notice of proposed Authorization for the Society's proposed helicopter operations and restoration/maintenance activities. Please include any supporting data or literature citations with your comments to help inform our final decision on the Society's request for an application.
U.S. Air Force Academy Board of Visitors
Meeting Notice.
In accordance with 10 U.S.C. Section 9355, the U.S. Air Force Academy (USAFA) Board of Visitors (BoV) will hold a meeting in Harmon Hall, United States Air Force Academy, in Colorado Springs CO on March 6-7, 2014. The meeting will begin at 9:00 a.m. The purpose of this meeting is to review morale and discipline, social climate, curriculum, instruction, infrastructure, fiscal affairs, academic methods, and other matters relating to the Academy. Specific topics for this meeting include a Superintendent's Update; a USAFA Non-profit Financial Support Briefing; a USAFA Curriculum Overview; a Graduate Assessment Survey Briefing; a Preparatory School Overview; a classroom visit and a tour of the Center for Innovation and Cyber Center Tour. In accordance with 5 U.S.C. 552b, as amended, and 41 CFR 102-3.155, one session of this meeting shall be closed to the public because it involves matters covered by subsection (c)(6) of 5 U.S.C. 552b. Public attendance at the open portions of this USAFA BoV meeting shall be accommodated on a first-come, first-served basis up to the reasonable and safe capacity of the meeting room. In addition, any member of the public wishing to provide input to the USAFA BoV should submit a written statement in accordance with 41 CFR 102-3.140(c) and section 10(a)(3) of the Federal Advisory Committee Act and the procedures described in this paragraph. Written statements must address the following details: The issue, discussion, and a recommended course of action. Supporting documentation may also be included as needed to establish the appropriate historical context and provide any necessary background information. Written statements can be submitted to the Designated Federal Officer (DFO) at the Air Force address detailed below at any time. However, if a written statement is not received at least 10 calendar days before the first day of the meeting which is the subject of this notice, then it may not be provided to or considered by the BoV until its next open meeting. The DFO will review all timely submissions with the BoV Chairman and ensure they are provided to members of the BoV before the meeting that is the subject of this notice. For the benefit of the public, rosters that list the names of BoV members and any releasable materials presented during the open portions of this BoV meeting shall be made available upon request. If after review of timely submitted written comments and the BoV Chairman and DFO deem appropriate, they may choose to invite
For additional information or to attend this BoV meeting, contact Maj Mark Cipolla, Accessions and Training Division, AF/A1PT, 1040 Air Force Pentagon, Washington, DC 20330, (703) 695-4066.
Department of the Army, U.S. Army Corps of Engineers, DOD.
Notice of Extension of Public Comment Period.
On January 6, 2014, USACE published a notice (79 FR 647) in the
The comment due date is extended to March 31, 2014. Comments must be received on or before March 31, 2014. Please refer to the
Interested persons are invited to submit comments in the following ways:
• GLMRIS project Web site: Use the web form found at
• Mail: Send written information to U. S. Army Corps of Engineers, Chicago District, GLMRIS ANS Control Comments, 231 S. LaSalle St., Suite 1500, Chicago, IL 60604. Comments must be postmarked by March 31, 2014; and
• Hand Delivery: Comments may be hand delivered to the USACE, Chicago District office located at 231 S. LaSalle St., Suite 1500, Chicago, IL 60604 between 8:00 a.m. and 4:30 p.m. Comments must be received by March 31, 2014.
Comments received during the comment period will be posted on the GLMRIS project Web site. You may indicate that you do not wish to have your name or other personal information made available on the Web site. However, USACE cannot guarantee that information withheld from the Web site will be maintained as confidential. Requests for disclosure of collected information will be handled through the Freedom of Information Act. Comments and information, including the identity of the submitter, may be disclosed, reproduced, and distributed. Submissions should not include any information that the submitter seeks to preserve as confidential.
For further information and/or questions about GLMRIS, please contact USACE, Chicago District, Project Manager, Mr. David Wethington,
For media inquiries, please contact USACE, Chicago District, Public Affairs Officer, Ms. Lynne Whelan,
1.
2.
This action is being undertaken pursuant to the Water Resources and Development Act of 2007, Section 3061, Pub. L. 110-114, and Section 1538 of Public Law 112-141 of the Moving Ahead for Progress in the 21st Century Act.
Department of the Army, DoD.
Notice of Advisory Committee meeting.
The Department of the Army is publishing this notice to announce the following Federal advisory committee meeting of the Board on Coastal Engineering Research. This meeting is open to the public.
The Board on Coastal Engineering Research will meet from 8:00 a.m. to 5:00 p.m. on March 18, 2014, and reconvene from 8:00 a.m. to 12:00 p.m. on March 19, 2014.
Both sessions of the meeting will be held in the Washington Room, Fort Hamilton Community Club, 207 Sterling Drive, Brooklyn, NY 11252.
Colonel Jeffrey R. Eckstein, Designated Federal Officer (DFO) and Executive Secretary, U.S. Army Engineer Research and Development Center, Waterways Experiment Station, 3909 Halls Ferry Road, Vicksburg, MS 39180-6199,
The meeting is being held under the provisions of the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150. The Board on Coastal Engineering Research provides broad policy guidance and reviews plans for the conduct of research and the development of research projects in consonance with the needs of the coastal engineering field and the objectives of the U.S. Army Chief of Engineers.
On Wednesday morning, March 19, 2014, the Board will reconvene to review and discuss knowledge gaps identified through and assessment of the Chief's Charge and through RD&T involvement in Hurricane Sandy response and recovery. In addition, the Board will receive a status report on experiment planning and expectations for the Field Research Facility Experiment Series for Fiscal Years 2015/2016. The meeting will close with a discussion about potential topics to consider in the context of the next Board meeting.
Office of Elementary and Secondary Education, Department of Education
Notice.
Notice inviting applications for new awards for fiscal year (FY) 2014.
Catalog of Federal Domestic Assistance (CFDA) Number: 84.356A.
Applications Available: February 18, 2014.
Deadline for Transmittal of Applications: April 21, 2014.
Congress has expressly authorized the use of FY 2014 program funds for construction of facilities that support the operation of Alaska Native education programs.
Priorities: This competition includes one competitive preference priority and one invitational priority. In accordance with 34 CFR 75.105(b)(2)(iv), the competitive priority is from section 7304(c) of the ESEA, as amended (20 U.S.C. 7544(c)). The invitational priority is for applications that propose to carry out activities that preserve and strengthen Native culture and language.
For FY 2014 and any subsequent year in which we make awards from the list of unfunded applicants from this competition, this priority is a competitive preference priority. Under 34 CFR 75.105(c)(2)(i) we award an additional 10 points to an application that meets this priority.
This priority is:
An applicant that is an Alaska Native regional nonprofit organization or a consortium that includes at least one Alaska Native regional nonprofit organization.
In order to receive a competitive preference under this priority, the applicant
Under this competition, we also are particularly interested in applications that address the following priority.
This priority is:
Applications that propose to carry out activities that preserve and strengthen Native culture and language.
The regulations in 34 CFR part 86 apply to institutions of higher education only.
Contingent upon the availability of funds and the quality of applications, we may make additional awards in FY 2015 from the list of unfunded applicants from this competition.
The Department is not bound by any estimates in this notice.
1.
A State educational agency (SEA) or local educational agency (LEA), including a charter school that is considered an LEA under State law, may apply for an award under this program only as part of a consortium involving an Alaska Native organization. The consortium may also include other eligible applicants.
2.
1.
Individuals with disabilities can obtain a copy of the application package in an accessible format (e.g., braille, large print, audiotape, or compact disc) by contacting the person or team listed under
2.
Page Limit: The application narrative is where you, the applicant, address the selection criteria that reviewers use to evaluate your application. You must limit the application narrative to no more than 25 pages, using the following standards:
• A “page” is 8.5″ x 11″, on one side only, with 1″ margins at the top, bottom, and both sides.
• Double space (no more than three lines per vertical inch) all text in the application narrative, including titles, headings, footnotes, quotations, references, and captions, as well as all text in charts, tables, figures, and graphs.
• Use a font that is either 12 point or larger or no smaller than 10 pitch (characters per inch).
• Use one of the following fonts: Times New Roman, Courier, Courier New, or Arial. An application submitted in any other font (including Times Roman or Arial Narrow) will not be accepted.
The page limit does not apply to the cover sheet; the budget section, including the narrative budget justification; the assurances and certifications; or the one-page abstract, the resumes, the bibliography, or the letters of support. However, the page limit does apply to all of the application narrative section.
Our reviewers will not read any pages of your application that exceed the page limit.
3.
Applications Available: February 18, 2014.
Deadline for Transmittal of Applications: April 21, 2014.
Applications for grants under this competition must be submitted electronically using the Grants.gov Apply site (
We do not consider an application that does not comply with the deadline requirements.
Individuals with disabilities who need an accommodation or auxiliary aid in connection with the application process should contact the person listed under
4.
5.
6.
a. Have a Data Universal Numbering System (DUNS) number and a Taxpayer Identification Number (TIN);
b. Register both your DUNS number and TIN with the System for Award Management (SAM) (formerly the Central Contractor Registry (CCR)), the Government's primary registrant database;
c. Provide your DUNS number and TIN on your application; and
d. Maintain an active SAM registration with current information while your application is under review by the Department and, if you are awarded a grant, during the project period.
You can obtain a DUNS number from Dun and Bradstreet. A DUNS number can be created within one-to-two business days.
If you are a corporate entity, agency, institution, or organization, you can obtain a TIN from the Internal Revenue Service. If you are an individual, you can obtain a TIN from the Internal Revenue Service or the Social Security Administration. If you need a new TIN, please allow 2-5 weeks for your TIN to become active.
The SAM registration process can take approximately seven business days, but may take upwards of several weeks, depending on the completeness and accuracy of the data entered into the SAM database by an entity. Thus, if you think you might want to apply for Federal financial assistance under a program administered by the Department, please allow sufficient time to obtain and register your DUNS number and TIN. We strongly recommend that you register early.
Once your SAM registration is active, you will need to allow 24 to 48 hours for the information to be available in
If you are currently registered with SAM, you may not need to make any changes. However, please make certain that the TIN associated with your DUNS number is correct. Also note that you will need to update your registration annually. This may take three or more business days.
Information about SAM is available at
In addition, if you are submitting your application via
7.
Applications for grants under this competition must be submitted electronically unless you qualify for an exception to this requirement in accordance with the instructions in this section.
a.
Applications for grants under the ANE program, CFDA number 84.356A, must be submitted electronically using the Governmentwide
We will reject your application if you submit it in paper format unless, as described elsewhere in this section, you qualify for one of the exceptions to the electronic submission requirement and submit, no later than two weeks before the application deadline date, a written statement to the Department that you qualify for one of these exceptions. Further information regarding calculation of the date that is two weeks before the application deadline date is provided later in this section under
You may access the electronic grant application for the ANE program at
Please note the following:
• When you enter the
• Applications received by
• The amount of time it can take to upload an application will vary depending on a variety of factors, including the size of the application and the speed of your Internet connection. Therefore, we strongly recommend that you do not wait until the application deadline date to begin the submission process through
• You should review and follow the Education Submission Procedures for submitting an application through
• You will not receive additional point value because you submit your application in electronic format, nor will we penalize you if you qualify for an exception to the electronic submission requirement, as described elsewhere in this section, and submit your application in paper format.
• You must submit all documents electronically, including all information you typically provide on the following forms: The Application for Federal Assistance (SF 424), the Department of Education Supplemental Information for SF 424, Budget Information—Non-Construction Programs (ED 524), and all necessary assurances and certifications.
• You must upload any narrative sections and all other attachments to your application as files in a .PDF (Portable Document) read-only, non-modifiable format. Do not upload an interactive or fillable .PDF file. If you upload a file type other than a read-only, non-modifiable .PDF or submit a password-protected file, we will not review that material.
• Your electronic application must comply with the page-limit requirements described in this notice.
• After you electronically submit your application, you will receive from Grants.gov an automatic notification of receipt that contains a Grants.gov tracking number. (This notification indicates receipt by Grants.gov only, not receipt by the Department.) The Department then will retrieve your application from Grants.gov and send a second notification to you by email. This second notification indicates that the Department has received your application and has assigned your application a PR/Award number (an ED-specified identifying number unique to your application).
• We may request that you provide us original signatures on forms at a later date.
If you are prevented from electronically submitting your application on the application deadline date because of technical problems with the Grants.gov system, we will grant you an extension until 4:30:00 p.m., Washington, DC time, the following business day to enable you to transmit your application electronically or by hand delivery. You also may mail your application by following the mailing instructions described elsewhere in this notice.
If you submit an application after 4:30:00 p.m., Washington, DC time, on the application deadline date, please contact the person listed under
The extensions to which we refer in this section apply only to the unavailability of, or technical problems with, the Grants.gov system. We will not grant you an extension if you failed to fully register to submit your application to Grants.gov before the application deadline date and time or if the technical problem you experienced is unrelated to the Grants.gov system.
• You do not have access to the Internet; or
• You do not have the capacity to upload large documents to the
and
• No later than two weeks before the application deadline date (14 calendar days or, if the fourteenth calendar day before the application deadline date falls on a Federal holiday, the next business day following the Federal holiday), you mail or fax a written statement to the Department, explaining which of the two grounds for an exception prevent you from using the Internet to submit your application.
If you mail your written statement to the Department, it must be postmarked no later than two weeks before the application deadline date. If you fax your written statement to the Department, we must receive the faxed statement no later than two weeks before the application deadline date.
Address and mail or fax your statement to: Almita Reed, U.S. Department of Education, 400 Maryland Avenue SW., room 3E335, Washington, DC 20202-6200.
FAX: (202) 260-8969.
Your paper application must be submitted in accordance with the mail or hand delivery instructions described in this notice.
b.
If you qualify for an exception to the electronic submission requirement, you may mail (through the U.S. Postal Service or a commercial carrier) your application to the Department. You must mail the original and two copies of your application, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Application Control Center, Attention: (CFDA Number 84.356A) LBJ Basement Level 1, 400 Maryland Avenue SW., Washington, DC 20202-4260.
You must show proof of mailing consisting of one of the following:
(1) A legibly dated U.S. Postal Service postmark.
(2) A legible mail receipt with the date of mailing stamped by the U.S. Postal Service.
(3) A dated shipping label, invoice, or receipt from a commercial carrier.
(4) Any other proof of mailing acceptable to the Secretary of the U.S. Department of Education.
If you mail your application through the U.S. Postal Service, we do not accept either of the following as proof of mailing:
(1) A private metered postmark.
(2) A mail receipt that is not dated by the U.S. Postal Service.
If your application is postmarked after the application deadline date, we will not consider your application.
The U.S. Postal Service does not uniformly provide a dated postmark. Before relying on this method, you should check with your local post office.
c.
If you qualify for an exception to the electronic submission requirement, you (or a courier service) may deliver your paper application to the Department by hand. You must deliver the original and two copies of your application by hand, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Application Control Center, Attention: (CFDA Number 84.356A) 550 12th Street SW., Room 7041, Potomac Center Plaza, Washington, DC 20202-4260.
The Application Control Center accepts hand deliveries daily between 8:00 a.m. and 4:30:00 p.m., Washington, DC time, except Saturdays, Sundays, and Federal holidays.
If you mail or hand deliver your application to the Department—
(1) You must indicate on the envelope and—if not provided by the Department—in Item 11 of the SF 424 the CFDA number, including suffix letter, if any, of the competition under which you are submitting your application; and
(2) The Application Control Center will mail to you a notification of receipt of your grant application. If you do not receive this notification within 15 business days from the application deadline date, you should call the U.S. Department of Education Application Control Center at (202) 245-6288.
1.
(a)
(b)
(i) The extent to which the goals, objectives, and outcomes to be achieved by the proposed project are clearly specified and measurable (10 points).
(ii) The extent to which the proposed project is supported by strong theory (as defined in 34 CFR 77.1(c)) (10 points).
(c)
(i) The adequacy of mechanisms for ensuring high-quality products and services from the proposed project (10 points).
(ii) The extent to which the time commitments of the project director and principal investigator and other key project personnel are appropriate and adequate to meet the objectives of the proposed project (10 points).
(d)
(e)
(i) The extent to which the methods of evaluation provide for examining the effectiveness of project implementation strategies (5 points).
(ii) The extent to which the methods of evaluation will provide performance feedback and permit periodic assessment of progress toward achieving intended outcomes (5 points).
(d)
2.
In addition, in making a competitive grant award, the Secretary also requires various assurances including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department of Education (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).
3.
1.
If your application is not evaluated or not selected for funding, we notify you.
2.
We reference the regulations outlining the terms and conditions of an award in the
3.
(b) At the end of your project period, you must submit a final performance report, including financial information, as directed by the Secretary. If you receive a multi-year award, you must submit an annual performance report that provides the most current performance and financial expenditure information as directed by the Secretary under 34 CFR 75.118. The Secretary may also require more frequent performance reports under 34 CFR 75.720(c). For specific requirements on reporting, please go to
4.
All grantees will be expected to submit an annual performance report that includes data addressing these performance measures, to the extent that they apply to the grantee's project.
5.
Almita Reed, U.S. Department of Education, 400 Maryland Avenue SW., room 3E335, Washington, DC 20202-6200. Telephone: (202) 260-1979 or by email:
If you use a TDD, call the FRS, toll free at 1-800-877-8339.
You may also access documents of the Department published in the
Office of Elementary and Secondary Education, Department of Education.
Notice.
Notice inviting applications for new awards for fiscal year (FY) 2014.
Catalog of Federal Domestic Assistance (CFDA) Number: 84.362A.
Applications Available: February 18, 2014.
Deadline for Transmittal of Applications: April 21, 2014.
Congress expressly authorized that FY 2014 program funds may be used to support the construction, renovation, or modernization of any elementary school, secondary school, or structure related to an elementary school or secondary school, that is run by the Department of Education of the State of Hawaii that serves a predominately Native Hawaiian student body.
These priorities are:
Projects that are designed to address the needs of at-risk children and youth.
Projects that are designed to address needs in fields or disciplines in which Native Hawaiians are underemployed.
Projects that are designed to address the use of the Hawaiian language in instruction.
Projects that are designed to address beginning reading and literacy among students in kindergarten through third grade.
Projects that are designed to improve school readiness and success for high-need children (as defined in this notice) from birth through third grade (or for any age group of high-need children within this range) through a focus on one or more of the following priority areas:
(a) Physical well-being and motor development.
(b) Social-emotional development.
(c) Language and literacy development.
(d) Cognition and general knowledge, including early numeracy and early scientific development.
(e) Approaches toward learning.
Projects that are designed to address one or more of the following priority areas:
(a) Accelerating learning and helping to improve high school graduation rates (as defined in this notice) and college enrollment rates for students in rural local educational agencies (as defined in this notice).
(b) Accelerating learning and helping to improve high school graduation rates (as defined in this notice) and college enrollment rates for students with disabilities.
(c) Accelerating learning and helping to improve high school graduation rates (as defined in this notice) and college enrollment rates for English learners.
(d) Accelerating learning and helping to improve high school graduation rates (as defined in this notice) and college enrollment rates for high-need students (as defined in this notice).
(e) Accelerating learning and helping to improve high school graduation rates (as defined in this notice) and college enrollment rates in high-poverty schools (as defined in this notice).
(f) Accelerating learning and helping to improve high school graduation rates (as defined in this notice) and college enrollment rates for all students in an inclusive manner that ensures that the specific needs of high-need students (as defined in this notice) participating in the project are addressed.
In order to receive additional points under a competitive preference priority, an application must provide adequate and sufficient information that clearly substantiates its claim that it meets the competitive priority.
The regulations in 34 CFR part 86 apply to institutions of higher education only.
Contingent upon the availability of funds and the quality of applications, we may make additional awards in FY 2015 from the list of unfunded applicants from this competition.
The Department is not bound by any estimates in this notice.
1.
2.
1.
You can contact ED Pubs at its Web site, also:
If you request an application from ED Pubs, be sure to identify this program or competition as follows: CFDA number 84.362A.
Individuals with disabilities can obtain a copy of the application package in an accessible format (e.g., braille, large print, audiotape, or compact disc) by contacting the person or team listed under
2.
Page Limit: The application narrative is where you, the applicant, address the selection criteria that reviewers use to evaluate your application. You must limit the application narrative to no
• A “page” is 8.5″ × 11″, on one side only, with 1″ margins at the top, bottom, and both sides.
• Double space (no more than three lines per vertical inch) all text in the application narrative.
• Use a font that is either 12 point or larger or no smaller than 10 pitch (characters per inch).
• Use one of the following fonts: Times New Roman, Courier, Courier New, or Arial. An application submitted in any other font (including Times Roman or Arial Narrow) will not be accepted.
The page limit does not apply to the cover sheet; the budget section, including the narrative budget justification; the assurances and certifications; the one-page abstract, the resumes, the bibliography, or the letters of support. However, the page limit does apply to all of the application narrative section.
Our reviewers will not read any pages of your application that exceed the page limit.
3.
Applications Available: February 18, 2014.
Deadline for Transmittal of Applications: April 21, 2014.
Applications for grants under this competition must be submitted electronically using the Grants.gov Apply site (Grants.gov). For information (including dates and times) about how to submit your application electronically, or in paper format by mail or hand delivery if you qualify for an exception to the electronic submission requirement, please refer to section IV. 7.
We do not consider an application that does not comply with the deadline requirements.
Individuals with disabilities who need an accommodation or auxiliary aid in connection with the application process should contact the person listed under
4.
5.
6.
a. Have a Data Universal Numbering System (DUNS) number and a Taxpayer Identification Number (TIN);
b. Register both your DUNS number and TIN with the System for Award (SAM) (formerly the Central Contractor Registry (CCR)), the Government's primary registrant database;
c. Provide your DUNS number and TIN on your application; and
d. Maintain an active SAM registration with current information while your application is under review by the Department and, if you are awarded a grant, during the project period.
You can obtain a DUNS number from Dun and Bradstreet. A DUNS number can be created within one-to-two business days.
If you are a corporate entity, agency, institution, or organization, you can obtain a TIN from the Internal Revenue Service. If you are an individual, you can obtain a TIN from the Internal Revenue Service or the Social Security Administration. If you need a new TIN, please allow 2-5 weeks for your TIN to become active.
The SAM registration process can take approximately seven business days, but may take upwards of several weeks, depending on the completeness and accuracy of the data entered into the SAM database by an entity. Thus, if you think you might want to apply for Federal financial assistance under a program administered by the Department, please allow sufficient time to obtain and register your DUNS number and TIN. We strongly recommend that you register early.
Once your SAM registration is active, you will need to allow 24 to 48 hours for the information to be available in Grants.gov and before you can submit an application through Grants.gov
If you are currently registered with SAM, you may not need to make any changes. However, please make certain that the TIN associated with your DUNS number is correct. Also note that you will need to update your registration annually. This may take three or more business days.
Information about SAM is available at
In addition, if you are submitting your application via Grants.gov, you must (1) be designated by your organization as an Authorized Organization Representative (AOR); and (2) register yourself with Grants.gov as an AOR. Details on these steps are outlined at the following Grants.gov Web page:
7.
Applications for grants under this competition must be submitted electronically unless you qualify for an exception to this requirement in accordance with the instructions in this section.
a.
Applications for grants under the NHE program, CFDA number 84.362A, must be submitted electronically using the Governmentwide Grants.gov Apply site at
We will reject your application if you submit it in paper format unless, as described elsewhere in this section, you qualify for one of the exceptions to the electronic submission requirement and submit, no later than two weeks before the application deadline date, a written statement to the Department that you qualify for one of these exceptions. Further information regarding calculation of the date that is two weeks before the application deadline date is provided later in this section under
You may access the electronic grant application for the NHE program at
Please note the following:
• When you enter the Grants.gov site, you will find information about submitting an application electronically through the site, as well as the hours of operation.
• Applications received by Grants.gov are date and time stamped. Your application must be fully uploaded and
• The amount of time it can take to upload an application will vary depending on a variety of factors, including the size of the application and the speed of your Internet connection. Therefore, we strongly recommend that you do not wait until the application deadline date to begin the submission process through Grants.gov.
• You should review and follow the Education Submission Procedures for submitting an application through Grants.gov that are included in the application package for this competition to ensure that you submit your application in a timely manner to the Grants.gov system. You can also find the Education Submission Procedures pertaining to Grants.gov under News and Events on the Department's G5 system home page at
• You will not receive additional point value because you submit your application in electronic format, nor will we penalize you if you qualify for an exception to the electronic submission requirement, as described elsewhere in this section, and submit your application in paper format.
• You must submit all documents electronically, including all information you typically provide on the following forms: The Application for Federal Assistance (SF 424), the Department of Education Supplemental Information for SF 424, Budget Information—Non-Construction Programs (ED 524), and all necessary assurances and certifications.
• You must upload any narrative sections and all other attachments to your application as files in a .PDF (Portable Document) read-only, non-modifiable format. Do not upload an interactive or fillable .PDF file. If you upload a file type other than a read-only, non-modifiable .PDF or submit a password-protected file, we will not review that material.
• Your electronic application must comply with the page-limit requirements described in this notice.
• After you electronically submit your application, you will receive from Grants.gov an automatic notification of receipt that contains a Grants.gov tracking number. (This notification indicates receipt by Grants.gov only, not receipt by the Department.) The Department then will retrieve your application from Grants.gov and send a second notification to you by email. This second notification indicates that the Department has received your application and has assigned your application a PR/Award number (an ED-specified identifying number unique to your application).
• We may request that you provide us original signatures on forms at a later date.
If you are prevented from electronically submitting your application on the application deadline date because of technical problems with the Grants.gov system, we will grant you an extension until 4:30:00 p.m., Washington, DC time, the following business day to enable you to transmit your application electronically or by hand delivery. You also may mail your application by following the mailing instructions described elsewhere in this notice.
If you submit an application after 4:30:00 p.m., Washington, DC time, on the application deadline date, please contact the person listed under
The extensions to which we refer in this section apply only to the unavailability of, or technical problems with, the Grants.gov system. We will not grant you an extension if you failed to fully register to submit your application to Grants.gov before the application deadline date and time or if the technical problem you experienced is unrelated to the Grants.gov system.
• You do not have access to the Internet; or
• You do not have the capacity to upload large documents to the Grants.gov system;
and
• No later than two weeks before the application deadline date (14 calendar days or, if the fourteenth calendar day before the application deadline date falls on a Federal holiday, the next business day following the Federal holiday), you mail or fax a written statement to the Department, explaining which of the two grounds for an exception prevent you from using the Internet to submit your application.
If you mail your written statement to the Department, it must be postmarked no later than two weeks before the application deadline date. If you fax your written statement to the Department, we must receive the faxed statement no later than two weeks before the application deadline date.
Address and mail or fax your statement to: Joanne Osborne, U.S. Department of Education, 400 Maryland Avenue SW., Room 3E214, Washington, DC 20202-6200. FAX: (202) 260-8969.
Your paper application must be submitted in accordance with the mail or hand delivery instructions described in this notice.
b.
If you qualify for an exception to the electronic submission requirement, you may mail (through the U.S. Postal Service or a commercial carrier) your application to the Department. You must mail the original and two copies of your application, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Application Control Center, Attention: (CFDA Number 84.362A) LBJ Basement Level 1, 400 Maryland Avenue SW., Washington, DC 20202-4260.
You must show proof of mailing consisting of one of the following:
(1) A legibly dated U.S. Postal Service postmark.
(2) A legible mail receipt with the date of mailing stamped by the U.S. Postal Service.
(3) A dated shipping label, invoice, or receipt from a commercial carrier.
(4) Any other proof of mailing acceptable to the Secretary of the U.S. Department of Education.
If you mail your application through the U.S. Postal Service, we do not accept either of the following as proof of mailing:
(1) A private metered postmark.
(2) A mail receipt that is not dated by the U.S. Postal Service.
If your application is postmarked after the application deadline date, we will not consider your application.
The U.S. Postal Service does not uniformly provide a dated postmark. Before relying on this method, you should check with your local post office.
c.
If you qualify for an exception to the electronic submission requirement, you (or a courier service) may deliver your paper application to the Department by hand. You must deliver the original and two copies of your application by hand, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Application Control Center, Attention: (CFDA Number 84.362A), 550 12th Street SW., Room 7041, Potomac Center Plaza, Washington, DC 20202-4260.
The Application Control Center accepts hand deliveries daily between 8:00 a.m. and 4:30:00 p.m., Washington, DC time, except Saturdays, Sundays, and Federal holidays.
If you mail or hand deliver your application to the Department—
(1) You must indicate on the envelope and—if not provided by the Department—in Item 11 of the SF 424 the CFDA number, including suffix letter, if any, of the competition under which you are submitting your application; and
(2) The Application Control Center will mail to you a notification of receipt of your grant application. If you do not receive this notification within 15 business days from the application deadline date, you should call the U.S. Department of Education Application Control Center at (202) 245-6288.
1.
(a)
(i) The magnitude of the need for the services to be provided or the activities to be carried out by the proposed project (10 points).
(ii) The extent to which the proposed project will focus on serving or otherwise addressing the needs of disadvantaged individuals (10 points).
(b)
(c)
(i) The extent to which the goals, objectives, and outcomes to be achieved by the proposed project are clearly specified and measurable (10 points).
(ii) The extent to which the proposed project is supported by strong theory (as defined in 34 CFR 77.1) (10 points).
(iii) The extent to which the proposed project represents an exceptional approach to the priority or priorities established for the competition (10 points).
(d)
(e)
(f)
(i) The extent to which the methods of evaluation are thorough, feasible, and appropriate to the goals, objectives, and outcomes of the proposed project (10 points).
(ii) The extent to which the evaluation will provide guidance about effective strategies suitable for replication or testing in other the settings (10 points).
2.
In addition, in making a competitive grant award, the Secretary also requires various assurances including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department of Education (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).
3.
1.
If your application is not evaluated or not selected for funding, we notify you.
2.
We reference the regulations outlining the terms and conditions of an award in the
3.
(b) At the end of your project period, you must submit a final performance report, including financial information, as directed by the Secretary. If you receive a multi-year award, you must submit an annual performance report that provides the most current performance and financial expenditure information as directed by the Secretary under 34 CFR 75.118. The Secretary may also require more frequent performance reports under 34 CFR 75.720(c). For specific requirements on reporting, please go to
4.
All grantees will be expected to submit an annual performance report that includes data addressing these performance measures, to the extent that they apply to the grantee's project.
5.
This consideration includes the review of a grantee's progress in meeting the targets and projected outcomes identified in its approved application, and whether the grantee has expended funds in a manner that is consistent with its approved application and budget. In making a continuation grant, the Secretary also considers whether the grantee is operating in compliance with the assurances in its approved application, including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).
Joanne Osborne, U.S. Department of Education, 400 Maryland Avenue SW., room 3E214, Washington, DC 20202-6200. Telephone: (202) 401-1265 or by email:
If you use a TDD or a TTY, call the FRS, toll free, at 1-800-877-8339.
You may also access documents of the Department published in the
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following exempt wholesale generator filings:
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following land acquisition reports:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests,
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
Any person desiring to protest in any of the above proceedings must file in accordance with Rule 211 of the Commission's Regulations (18 CFR 385.211) on or before 5:00 p.m. Eastern time on the specified comment date.
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and § 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that on February 6, 2014, pursuant to section 206 of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.206 and section and 206 of the Federal Power Act, 16 U.S.C. 824(e), the New York Association of Public Power (NYAPP) filed a formal complaint against Niagara Mohawk Power Corporation (NMPC) and The New York Independent System Operator, Inc. (NYISO) alleging that, NMPC's use of an 11.5 percent return on common equity (ROE) in calculating rates for transmission services under the NYISO's Open Access Transmission Tariff (OATT) rate is unjust and unreasonable. NYAPP requests the Commission issue an order to reduce the 11.5 percent ROE used in calculating rates for transmission service under the NYISO's OATT to a just and reasonable level of 9.46 percent, inclusive of a 50 basis point adder for participation in the NYISO, with a corresponding overall weighted cost of capital of 6.60 percent.
The NYAPP certifies that copies of the complaint were served on the contacts of NMPC and the NYISO as listed on the Commission's list of Corporate Officials.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. The Respondent's answer and all interventions, or protests must be filed on or before the comment date. The Respondent's answer, motions to intervene, and protests must be served on the Complainants.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
In accordance with the National Environmental Policy Act of 1969 and the Federal Energy Regulatory Commission's regulations, 18 CFR Part 380, the Office of Energy Projects has reviewed the application for an original license for the proposed 30-megawatt (MW) Tygart Hydroelectric Project to be located on the Tygart River in Taylor County, West Virginia, at the U.S. Army Corps of Engineers' (Corps) Tygart Dam and has prepared an environmental assessment (EA).
In the EA, Commission staff analyzes the potential environmental effects of licensing the project and concludes that issuing a license for the construction and operation of the project, with appropriate environmental protective measures, would not constitute a major federal action that would significantly affect the quality of the human environment.
A copy of the EA is available for review at the Commission in the Public Reference Room or may be viewed on
You may also register online at
Comments on the EA should be filed within 30 days from the date of this notice.
The Commission strongly encourages electronic filing. Please file comments using the Commission's eFiling system at
This is a supplemental notice in the above-referenced proceeding of Verso Androscoggin Power LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR Part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR Part 34, of future issuances of securities and assumptions of liability, is March 3, 2014.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Environmental Protection Agency (EPA).
Notice.
This document announces the Office of Management and Budget (OMB) responses to Agency Clearance requests, in compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et. seq.). 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 OMB control number. The OMB control numbers for EPA regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.
Rick Westlund (202) 566-1682, or email 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:
602-379-6750 Ext. 1256.
Environmental Protection Agency (EPA).
Notice of meeting.
Pursuant to the Federal Advisory Committee Act, Public Law 92-463, notice is hereby given that the Mobile Sources Technical Review Subcommittee (MSTRS) will meet virtually on March 3, 2014. The MSTRS is a subcommittee under the Clean Air Act Advisory Committee. This is an open meeting. The meeting will include discussion and review of the SmartWay Legacy Fleet Work Group's Report. The preliminary agenda for the meeting and any notices about change in venue will be posted on the Subcommittee's Web site:
Monday, March 3, 2014 from 3:00 p.m. to 4:30 p.m. EST.
Elizabeth Etchells, Designated Federal Officer, Transportation and Climate Division, Mailcode 6406J, U.S. EPA, 1200 Pennsylvania Ave. NW., Washington, DC 20460; Ph: 202-343-9231; email:
Background on the work of the Subcommittee is available at:
During the meeting, the Subcommittee may also hear progress reports from some of its workgroups as well as updates and announcements on activities of general interest to attendees.
Environmental Protection Agency.
Notice.
The U.S. Environmental Protection Agency's (EPA) Office of Environmental Information (OEI) is giving notice that it proposes to create a new system of records pursuant to the provisions of the Privacy Act of 1974 (5 U.S.C. 552a). EPA is implementing the My Workplace system of records utilizing Microsoft Office 365 and SharePoint Online to deliver a cost effective, user-friendly, collaboration solution that will enhance productivity by facilitating communication, coordination and collaboration Agency-wide.
Persons wishing to comment on this system of records notice must do so by March 31, 2014.
Submit your comments, identified by Docket ID No. EPA-HQ-OEI-2013-0731, by one of the following methods:
•
•
•
•
•
Lin Darlington, Associate Chief, Policy and Program Management Branch, Office of Information Analysis and Access, Office of Environmental Information, 202-566-0696.
EPA proposes to create a new system of records under the Privacy Act to enhance the Agency's communication and collaboration environment. EPA is implementing My Workplace, utilizing Microsoft Office 365 and SharePoint Online, to deliver a cost effective, user-friendly, agency-wide collaboration solution that will help transform the way employees work at EPA. My Workplace will enhance productivity by making it easier for the Agency's multi-disciplinary, geographically dispersed workforce stay better informed by facilitating communication, coordination, collaboration and innovation, thus allowing EPA to deliver better on its mission of protecting human health and the environment.
The My Workplace collaboration tool will contain information about employees obtained from other Agency systems (e.g., name, user id, work phone number) or voluntarily provided by the users (e.g., home phone number, home address). The system will contain employees' names, user identification numbers, telephone numbers, office numbers and locations, organizational information, skill sets, education and experience. This information will be used to foster communication and enhance the ability of employees to locate individuals with relevant experience and skill sets.
EPA plans to use a feature of the system that consists of personalized profiles for each employee as an Agency directory to help connect subject matter experts to Agency projects. The profiles will include work-related information (office location, office phone number) as well as optional information voluntarily provided by the employee such as work experience and educational history or photographs. The use of the profile will improve information sharing and collaboration among colleagues and make it easier for EPA staff to locate the knowledge skills and abilities required for Agency projects and initiatives.
My Workplace will use Lync, an instant messaging and video conferencing tool, to promote discussion and communication through instant messaging and online meetings. Lync will include the information contained in the personalized profiles and will temporarily display additional information about a user's presence or status, based on the user's online activity, (e.g., “user has been away for 20 minutes”). This feature is active by default, but users may disable it. Users will also have the option of posting a personalized status message for other users to see on their profile. The information for both Lync and the personalized profiles will be stored in Microsoft's Shared Government Cloud and will be accessible by users of the system. Initial profile information will be populated using EPA's existing directory information; however, users will have the ability to update and manage their profiles.
My Workplace will allow users to establish team collaboration workspaces; facilitate sharing of documents, policies and information; and network through the SharePoint features. The SharePoint environment will include Agency policies, procedures, forms, organization charts, links to other sites that are helpful for users, and links to other EPA SharePoint sites containing shared documents and other information. Sharepoint will include content on program and regional offices, services and support,
The system will be managed and maintained by EPA's Office of Environmental Information.
My Workplace
Environmental Protection Agency (EPA), Office of Environmental Information (OEI), 1200 Pennsylvania Ave. NW., Washington, DC 20460.
EPA employees, contractors on the EPA network and invited stakeholders, including but not limited to grantees, contractors, other federal or state officials, and industry partners.
For EPA employees this includes, but is not limited to, user name, common name or nickname, email address, organization, supervisor name, subordinates, office telephone, telework telephone, government cell phone number, fax number, personal cell phone, home phone, blackberry PIN, building location, office location, mail code, mailing address, courier address, home address, employee's title or position classification, other position title, professional affiliation, clearances, skills, disciplines with experience and knowledge, current and past projects and work activities, membership in inter-Agency or intra-agency formal workgroups or informal communities of practice, membership in professional associations, education, certifications, publications, detail status and photograph. Additionally, users of Lync may have status information, personalized messages and photographs.
5 U.S.C. 301, 40 U.S.C. 11315, 44 U.S.C. 3506.
To enhance and improve efficiencies in the dissemination and exchange of information within the EPA and allow colleagues to more easily connect with each other.
EPA's General Routine Uses: A, C, D, E, F, G, H, J, K, L apply to this system. Please refer to
Computer records are stored on a secure server and accessed over the Web via encryption software. Paper records, when created, are kept in file folders and cabinets in secure rooms. When individuals download information, it is stored on encrypted, password secured Agency computers. All records will have appropriate administrative, technical and physical safeguards to ensure their security and confidentiality.
Information is retrievable by name of the user; organizational information is retrievable by organization name.
Records in the system are protected from unauthorized access and misuse through various administrative, technical and physical security measures. Technical security measures within EPA include restrictions on computer access to authorized individuals, required use of strong passwords that are frequently changed, use of encryption for certain data types and transfers, and regular review of security procedures and best practices to enhance security. Physical measures include restrictions on building access to authorized individuals, only, and by maintaining records in lockable offices and filing cabinets.
The records will be managed in accordance with EPA retention schedule 129, Item b.
Lin Darlington, Office of Environmental Information, 1200 Pennsylvania Ave. NW., Washington, DC 20460.
Requests to determine whether this system of records contains a record pertaining to you must be sent to the Agency's Freedom of Information Office. The address is U.S. Environmental Protection Agency; 1200 Pennsylvania Ave. NW., Room 6416, WJC West, Washington, DC 20460; (202) 566-1667; Email:
Individuals seeking access to their own personal information in this system of records are required to provide adequate identification (e.g., driver's license, military identification card, employee badge or identification card and, if necessary, proof of authority). Additional identity verification procedures may be required as warranted. Requests must meet the requirements of EPA regulations at 40 CFR part 16.
Requests for correction or amendment must identify the record to be changed and the corrective action sought. Requests must be submitted to the Agency contact indicated on the initial document for which the related contested record was submitted.
The sources for information in the system are the individuals about whom the records are maintained and other EPA information systems.
None.
Environmental Protection Agency.
Notice.
Pursuant to the provisions of the Privacy Act of 1974 (5 USC 552a), the Environmental Protection Agency (EPA) is giving notice that it is amending the Federal Docket Management System (FDMS) system of records to include additional categories of records. The amendment is required
Persons wishing to comment on this system of records notice must do so by March 31, 2014.
Submit your comments, identified by Docket ID No. EPA-HQ-OEI-2012-0483 by one of the following methods:
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eRulemaking Program Management Office, (202) 566-1385, U.S. EPA, Office of Environmental Information, M/C 2282T, 1200 Pennsylvania Ave. NW., Washington, DC 20460.
EPA is amending the Federal Docket Management System (FDMS) (System number: EPA-GOV-2) to include additional categories of records. The original system of record notice for FDMS was published in the
Some agencies require individuals to provide personally identifiable information when submitting a comment (e.g., name and contact information) that the agency can use if it experiences a problem receiving the comment or requires additional information to process the comment. A comment that meets all requirements of the recipient agency will be posted on the regualtions.gov Web site for public viewing. All the contents of posted comments will be searchable. Each agency manages, accesses, and controls the information in the regulatory system that is submitted to it and maintains the sole ability to disclose the information it receives.
The FOIA system, FOIAonline, is used by participating agencies to administratively control and process requests for records in compliance with FOIA and to automate agency FOIA administration activities. FOIAonline provides a secure, login access Web site for agencies to receive and store requests; assign and process requests; post responses online; produce agencies' annual reports to the Department of Justice and manage FOIA requests electronically. The system allows the public to submit and track requests; search and download requests and responsive records; correspond with processing staff and file appeals as registered users. Each participating agency manages, accesses, and controls requests submitted to it through FOIAonline, including responding to requests for information in the possession of the agency and making information available in the system's repository of released records. The types of FOIA requests submitted to agencies by FOIA requesters vary according to an agency's mission as does the type of information an agency requires from requesters when they submit a FOIA. Social security numbers and other types
The name of a FOIA requester will be publicly available and searchable by the public based on an Agency's policies. With the exception of a requester's name, any other personally identifiable information provided by a requester during the process of completing the online request form or creating an online account (e.g., home addresses, email address and contact information) will not be posted to the Web site, nor will it be searchable by the public. Personally identifiable information determined to be publicly releasable and contained in documents released to the public under FOIA (e.g., the names and official contact information of government employees or the names of agency correspondents) will be publicly available and searchable by the public if posted by a participating agency based on their internal policies.
Federal Docket Management System (FDMS)
U.S. EPA, Research Triangle Park, NC.
Any individual commenting on a federal agency's rulemaking activities or submitting supporting materials and individuals requesting access to records pursuant to the Freedom of Information Act, 5 U.S.C. 552 (FOIA) or appealing initial denials of their requests.
Agency rulemaking materials including, but not limited to,
Section 206(d) of the E-Government Act of 2002 (Pub. L. 107-347, 44 U.S.C. Ch 36); Freedom of Information Act, 5 U.S.C. 552; Privacy Act of 1974, 5 U.S.C. 552a; Clinger-Cohen Act of 1986, 40 U.S.C. 11318; and 5 U.S.C. 301.
To provide the public a central online location to search, view, download and comment on Federal rulemaking documents and a single location to submit and track FOIA requests and appeals filed with participating agencies, along with providing the agencies electronic FOIA processing and administrative capabilities.
FDMS security protocols meet all required security standards issued by the National Institute of Science and Technology (NIST). Records in FDMS are maintained in a secure, password protected electronic system that utilizes security hardware and software to include multiple firewalls, active intruder detection, and role-based access controls. Additional safeguards will vary by agency.
The system has the ability to retrieve records by numerous data elements and key word searches, including name, agency, dates, subject, docket type, docket sub-type, agency docket ID, docket title, docket category, document type, CFR Part, date received and
The public may access regulatory records in the system at
FDMS security protocols meet multiple NIST security standards from authentication to certification and accreditation. Records in the system are maintained in a secure, password protected electronic system that utilizes security hardware and software to include multiple firewalls, active intruder detection, and role-based access controls. Additional safeguards vary by agency for the regulatory records. Security controls are commensurate with those required for an information system rated moderate for confidentiality, integrity and availability as prescribed by NIST.
Each Federal agency handles its records in accordance with its records schedule as approved by the National Archives and Records Administration (NARA). FOIA records are covered under NARA General Record Schedule 14—Information Services Records unless a participating agency's records are managed under other record schedules approved by NARA.
eRulemaking PMO, Office of Information Collection, Office of Environmental Information, U.S. EPA, M/C 2821T, 1200 Pennsylvania Ave. NW., Washington, DC 20460.
Any individual who wants to know whether this system of records contains a record about him or her, who wants access to his or her record, or who wants to contest the contents of a record, should contact the agency conducting the rulemaking activity or to the agency that provided the FOIA response, as appropriate.
Individuals seeking access to their own personal information in this system of records is required to provide adequate identification (e.g., driver's license, military identification card, employee badge or identification card and, if necessary, proof of authority). Additional identity verification procedures may be required as warranted. Requests must meet the
Requests for correction or amendment must identify the record to be changed and the corrective action sought. Requests must be submitted to the agency contact indicated on the initial document for which the related contested record was submitted.
Records deriving for individuals commenting on federal rulemaking activities and filing FOIA requests and appeals.
None.
Environmental Protection Agency (EPA).
Notice of proposed consent decree; request for public comment.
In accordance with section 113(g) of the Clean Air Act, as amended (“CAA” or the “Act”), notice is hereby given of a proposed consent decree to address a lawsuit filed by Sierra Club in the United States District Court for the District of Columbia:
Written comments on the proposed consent decree must be received by
Submit your comments, identified by Docket ID number EPA-HQ-OGC-2014-0150, online at
Karen Bennett Bianco, Air and Radiation Law Office (2344A), Office of General Counsel, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone: (202) 564-3298; fax number: (202) 564-5603; email address:
The proposed consent decree would resolve a lawsuit filed by Sierra Club seeking to compel the Administrator to take actions under CAA sections 110(k)(2), (3) and 505(b)(2). Under the terms of the proposed consent decree, EPA would agree to sign a notice of final rulemaking to approve, disapprove, or approve in part and disapprove in part Georgia's July 20, 2010 SIP Submittal addressing Georgia Rule for Air Quality 391-3-1-.02(uuu) (“GA SIP”) no later than November 16, 2016, unless Georgia withdraws its July 20, 2010 SIP submittal. The proposed consent decree also states that no later than April 14, 2014, EPA shall sign its response granting or denying the Sierra Club petitions regarding Georgia Power Company's Scherer Steam-Electric Generating Plant, Permit No. 4911-207-0008-V-03-0, Hammond Steam-Electric Generating Plant, Permit No. 4911-115-0003-V-03-0, Wansley Steam-Electric Generating Plan, Permit No. 4911-149-0001-V-03-0, Kraft Steam-Generating Plant, Permit No. 4911-051-0006-V-03-0, and McIntosh Steam-Electric Generating Plant, Permit No. 4911-103-0003-V-03-0, pursuant to section 505(b)(2) of the CAA.
Under the terms of the proposed consent decree, EPA will deliver notice of each action to the Office of the Federal Register for review and publication within 15 business days of signature. In addition, the proposed consent decree outlines the procedure for the Plaintiff to request costs of litigation, including attorney fees.
For a period of thirty (30) days following the date of publication of this notice, the Agency will accept written comments relating to the proposed consent decree from persons who are not named as parties or intervenors to the litigation in question. EPA or the Department of Justice may withdraw or withhold consent to the proposed consent decree if the comments disclose facts or considerations that indicate that such consent is inappropriate, improper, inadequate, or inconsistent with the requirements of the Act. Unless EPA or the Department of Justice determines that consent to this consent decree should be withdrawn, the terms of the consent decree will be affirmed.
The official public docket for this action (identified by Docket ID No. EPA-HQ-OGC-2014-0150) contains a copy of the proposed consent decree. The official public docket is available for public viewing at the Office of Environmental Information (OEI) Docket in the EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OEI Docket is (202) 566-1752.
An electronic version of the public docket is available through
It is important to note that EPA's policy is that public comments, whether submitted electronically or in paper,
You may submit comments as provided in the
If you submit an electronic comment, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment and with any disk or CD ROM you submit. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. Any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.
Use of the
Federal Communications Commission.
Notice and request for comments.
As part of an effort to streamline the process to seek feedback from the public on service delivery, the Federal Communications Commission (FCC) has submitted a Generic Information Collection Request to OMB for approval under the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520). The FCC invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; and ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a valid OMB control number.
Written Paperwork Reduction Act (PRA) comments should be submitted on or before April 21, 2014. If you anticipate that you will be submitting PRA comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the FCC contact listed below as soon as possible.
Submit your PRA comments to Walter Boswell, Federal Communications Commission, via the Internet at
Walter Boswell, Office of Managing Director, (202) 418-2178 or by email at
Office of Government-wide Policy, General Services Administration.
Notice.
The purpose of this notice is to announce a challenge competition hosted by GSA's Office of Government-wide Policy that will begin on February 14th, 2014. The competition will be open until April 11, 2014. The competition details can be viewed at
February 18, 2014.
Ms. Katherine Pearlman at
The U.S. General Services Administration (GSA) manages a broad portfolio of key, government-wide operations and policies. In managing this portfolio, GSA has access to extensive government operations data—data which may hold potential solutions to some federal agencies' most pressing problems. GSA's Office of Government-wide Policy, sponsor of the Travel Data Challenge, is looking to bring a quantitative approach to the data the federal government collects in order to help agencies make smarter business decisions, and to allow them to drive greater saving and efficiencies. Pursuing this goal supports several of GSA's highest priorities in serving our partners, including delivering better value and savings, and leading with innovation.
In this GSA Travel Data Challenge, the public is asked to develop a technology-driven solution using GSA travel data that allows an agency to identify opportunities to reduce costs. As such, GSA challenges the public to create a tool using GSA travel data that could be replicated across government to every agency, using their own travel data. Sample data sets with GSA travel data will be provided. However, in order to solve the key purpose of this competition, challenge solvers should address how the tool can be replicated using travel data from other agencies. This tool is intended to show agencies where and how they can save money on federal travel. The tool is not intended to publicly display any agency's travel data and users will need to log in via a certified username and password to interact with the tool. One of the key purposes of the tool will be to provide agencies with visibility into their travel spending and recommendations for cost-savings behaviors. In addition, the tool will enhance internal transparency and hold agencies accountable for their spending—steps which help to save money for American taxpayers.
A second part of the GSA Travel Data Challenge asks the public to identify specific gaps in the travel data collected by the government, and to provide recommendations for how the government can improve insights into federal travel spending through additional data collection. The purpose for this information is to gain an understanding of what the government could do with additional data elements, if those data elements were to be collected by agencies. This will help increase awareness of needed improvements in data collection, and further the goal of leading greater transparency into government spending.
Design and create a digital interactive tool that utilizes federal travel data collected by GSA, in coordination with any other publicly available data sets. The technology tool should be innovative! GSA does not want an analysis tool that tells what is already known. This should be a forward-thinking tool that enhances transparency and helps to hold agencies accountable for what they are spending on travel, while also providing agencies with recommendations for how to reduce costs.
The tool should visually display data to provide meaningful insights that can help drive smarter travel decisions by federal employees. The ultimate goal is to help federal agencies drive cost saving behaviors in travel through easy to understand information. The tool should accomplish two tasks:
(1) Visually display data in a way that will show agencies how and where they are spending money on travel, and
(2) Through analysis of the data, show primary categories or cost drivers that can enable federal agencies to reduce and/or contain official travel costs compared to appropriate benchmarks (as determined through research as well as the sample data provided). Focus on attributes that consistently result in the travelers acquiring the lowest cost of a trip. Use this information to benchmark historical data against real time planning and provide action items to help travel managers monitor and improve traveler behaviors, resulting in greater travel savings through transparency. Finally, identify valuable insights that could be gained through improved data collection efforts.
Are travelers booking airline reservations far in advance to secure low cost airfare? How many days in advance are travelers booking their trips, taking into consideration industry standards and benchmarks? For example, is there a correlation between booking time and cost?
Are travelers utilizing travel services, such as FedRooms
Are travelers booking online?
With regard to data visibility issues, is key data being missed? Highlight where data is missing, e.g., where a traveler
What data elements are missing that could be valuable to an agency travel manager or chief financial officer?
How much could an agency save if they adjusted one or a set of cost-driving behaviors such as, time of year of travel, booking online, travel to certain cities during certain times, booking in advance?
Challenge solvers will be provided with sample data sets to use in designing the tool. The tool should have the capability to be updated with data from additional agencies, making the tool scalable, dynamic, and configurable. Challenge solvers should not be limited to only the data provided. Be creative and use other public data sets that can give users a better understanding of their travel options. Document all data sources and explain why they are useful. Examples of additional resources include data.gov, City Pairs, per diem rates, and Fedrooms property lists. You are encouraged to conduct research in order to find other data sources that are publicly available.
Eligibility to participate in the GSA Travel Data Challenge and win a prize is limited to entities/individuals that:
(1) Have agreed to the rules of the competition as explained in this posting. (2) Are either a private entity or individual, provided further that in the case of a private entity, it is incorporated in and maintains a primary place of business in the United States, and in the case of an individual, whether participating singly or in a group, is a citizen or permanent resident of the United States; and that the participant is not a federal entity or federal employee acting within the scope of employment. An individual or entity shall not be deemed ineligible because the individual or entity used federal facilities or consulted with federal employees during a competition if the facilities and employees are made available to all individuals and entities participating in the competition on an equitable basis.
Participants agree to assume any and all risks and waive claims against the Federal Government and its related entities, except in the case of willful misconduct, for any injury, death, damage, or loss of property, revenue, or profits, whether direct, indirect, or consequential, arising from participation in this competition, whether the injury, death, damage, or loss arose through negligence or otherwise. Participants also agree to obtain liability insurance or demonstrate financial responsibility, in an amount to cover a third party for death, bodily injury, property damage, or loss resulting from an activity carried out in connection with participation in this competition. Entrants are hereby advised that diligent care must be taken to avoid the appearance of Government endorsement of Entrant's competition participation and submission. Moreover, as is customary when doing business with the Federal Government, Entrant may not refer to GSA's use of your submission (be it product or service) in any commercial advertising or similar promotions in a manner that states or implies that the product or service being used is endorsed or preferred by GSA or any other element of the Federal Government, or that the Federal Government considers it to be superior to other products or services. The intent of this policy is to prevent the appearance of Federal Government bias toward any one product or service.
Entrant agrees that GSA's trademarks, logos, service marks, trade names, or the fact that GSA awarded a prize to Entrant, shall not be used by Entrant to imply direct GSA endorsement of Entrant or Entrant's submission. Both Entrant and GSA may list the other party's name in a publicly available customer or other list so long as the name is not displayed in a more prominent fashion than any other third party name.
GSA may award up to three prizes but is not required to award all three prizes if the judges determine that only one or two entries meet the scope and requirements laid out for this challenge, or if the Agency plans to only use code from one or two entries. Funding for this GSA Travel Data Challenge award will come from the Office of Government-wide Policy's FY2014 Budget and will be made to winner(s) of the competition via electronic funds transfer, within 30 days of announcement of the winner(s).
The prizes may include three awards:
Grand Prize: $35,000.
Runner up: $30,000.
Honorable mention: $25,000.
The final product should be a tool that is housed online and can be updated to include data sets from other agencies. Capabilities should also include updating data in the most efficient time cycle, such as monthly, quarterly, annually or as new information becomes available.
The final tool should be in Open Source Code. Open source refers to a program in which the source code is available to the general public for use and/or modification from its original design free of charge. In order to be Open Source Initiative Certified, the tool must meet following six criteria:
1. The author or holder of the license of the source code cannot collect royalties on the distribution of the program;
2. The distributed program must make the source code accessible to the user;
3. The author must allow modifications and derivations of the work under the program's original name;
4. No person, group, or field of endeavor can be denied access to the program;
5. The rights attached to the program must not depend on the program being part of a particular software distribution; and
6. The licensed software cannot place restrictions on other software that is distributed with it.
The winner(s) of the competition will, in consideration of the prize to be awarded, grant to GSA a perpetual, non-exclusive, royalty-free license to use any and all intellectual property to the winning entry for any governmental purpose, including the right to permit such use by any other agency or agencies of the Federal Government. All other rights of the winning entrant will be retained by the winner of the competition.
Any federal travel data and information that is publicly available is included in the scope of this challenge. Summary-level sample data will be provided.
The solution must be an online, interactive tool that meets the goals and objectives provided in this document.
The solution must be in open source code.
The solution must include documentation of all data sources used.
The solution must include a description of how the tool can be updated with additional data from other agencies
The solver must provide recommendations to enhance Government insights through improvements in data collection.
There will be six judges, each a senior career official of GSA with expertise in government-wide policy, travel, information technology, and/or acquisition. Each judge will award a score to each submission and the winner(s) of the competition will be decided based on the highest average overall score. GSA will also have a technical advisor from Sabre, Inc who will assist the judges in evaluating the submissions as needed. However, the technical advisor will not vote in determining the prizes. Judges will only participate in judging submissions for which they do not have any conflicts of interest.
Judges are: Anne Rung, GSA Associate Administrator for Government-wide Policy—Craig Flynn, Director—Travel Policy Division, Office of Government-wide Policy—Kris Rowley, GSA Office of the Chief Information Officer—Tim Burke, GSA Federal Acquisition Service—Jon Bearscove, GSA FAS Region 10—Sonny Hashmi—Acting Chief Information Officer—GSA Technical Advisor: Sam Gilliland, Sabre Technologies.
Entries must be submitted online via ChallengePost by 11:59 p.m. EST on April 11th, 2014.
Agency for Healthcare Research and Quality, HHS.
Notice.
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: “Pharmacy Survey on Patient Safety Culture Comparative Database.” In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection.
This proposed information collection was previously published in the
Comments on this notice must be received by March 20, 2014.
Written comments should be submitted to: Doris Lefkowitz, Reports Clearance Officer, AHRQ, by email at
Copies of the proposed collection plans, data collection instruments, and specific details on the estimated burden can be obtained from the AHRQ Reports Clearance Officer.
Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at
In 1999, the Institute of Medicine called for health care organizations to develop a “culture of safety” such that their workforce and processes focus on improving the reliability and safety of care for patients (IOM, 1999;
The AHRQ Pharmacy Survey on Patient Safety Culture (Pharmacy SOPS) Comparative Database consists of data from the AHRQ Pharmacy Survey on Patient Safety Culture. Pharmacies in the U.S. are asked to voluntarily submit data from the survey to AHRQ, through its contractor, Westat. The Pharmacy SOPS Database is modeled after three other SOPS databases: Hospital SOPS [OMB NO. 0935-0162; Approved 05/04/2010]; Medical Office SOPS [OMB NO. 0935-0196; Approved 06/12/12]; and Nursing Home SOPS [OMB NO. 0935-0195; Approved 06/12/12] that were originally developed by AHRQ in response to requests from hospitals, medical offices, and nursing homes interested in knowing how their patient safety culture survey results compare to those of other similar health care organizations.
The goal of this project is to create the Pharmacy SOPS Comparative Database. This database will:
(1) Allow pharmacies to compare their patient safety culture survey results with those of other pharmacies,
(2) provide data to pharmacies to facilitate internal assessment and learning in the patient safety improvement process, and
(3) provide supplemental information to help pharmacies identify their strengths and areas with potential for improvement in patient safety culture.
This study is being conducted by AHRQ through its contractor, WESTAT, pursuant to AHRQ's statutory authority to conduct and support research on healthcare and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness and value of healthcare services and with respect to quality measurement and improvement. 42 U.S.C. 299a(a)(1) and (2).
To achieve these goals the following data collections will be implemented:
(1) Registration Form—The point-of-contact (POC), the pharmacy manager or a survey participating organization, completes a number of data submission steps and forms, beginning with completion of an online Registration Form. The purpose of this form is to collect basic demographic information about the pharmacy and initiate the registration process.
(2) Pharmacy Background Characteristics Form—The purpose of this form, completed by the pharmacy manager or a participating organization, is to collect background characteristics of the pharmacy. This information will be used to analyze data collected with the Pharmacy SOPS survey.
3) Data Use Agreement—The purpose of the data use agreement, completed by the pharmacy manager or participating organization is to state how data submitted by pharmacies will be used and provide confidentiality assurances.
(4) Data Files Submission -POCs upload their data file(s), using the pharmacy data file specifications, to ensure that users submit standardized and consistent data in the way variables are named, coded, and formatted. The number of submissions to the database is likely to vary each year because pharmacies do not administer the survey and submit data every year.
Survey data from the AHRQ Pharmacy Survey on Patient Safety Culture are used to produce three types of products: (1) A Pharmacy SOPS Comparative Database Report that is made publicly available on the AHRQ Web site, (2) Individual Pharmacy Survey Feedback Reports that are confidential, customized reports produced for each pharmacy that submits data to the database (the number of reports produced is based on the number of pharmacies submitting each year); and (3) Research data sets of individual-level and pharmacy-level de-identified data to enable researchers to conduct analyses.
Exhibit 1 shows the estimated annualized burden hours for the respondent's time to participate in the database. An estimated 150 POCs, each representing an average of 10 individual pharmacies each, will complete the database submission steps and forms annually. Completing the registration form will take about 5 minutes. The Pharmacy Background Characteristics Form is completed by all POCs for each of their pharmacies (150 x 10 = 1,500 forms in total) and is estimated to take 5 minutes to complete. Each POC will complete a data use agreement which takes 3 minutes to complete and submitting the data will take an hour on average. The total burden is estimated to be 296 hours.
Exhibit 2 shows the estimated annualized cost burden based on the respondents' time to submit their data. The cost burden is estimated to be $14,392 annually.
Mean hourly wage rate of $48.62 for General and Operations Managers (SOC code 11-1021) was obtained from the May 2012 National Industry-Specific Occupational Employment and Wage Estimates, NAICS 446110—Pharmacies and Drug Stores located at
In accordance with the above-cited Paperwork Reduction Act legislation, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ health care research, quality improvement and information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.
Agency for Healthcare Research and Quality, HHS.
Notice.
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project:
This proposed information collection was previously published in the
Comments on this notice must be received by March 20, 2014.
Written comments should be submitted to: Doris Lefkowitz, Reports Clearance Officer, AHRQ, by email at
Copies of the proposed collection plans, data collection instruments, and specific details on the estimated burden can be obtained from the AHRQ Reports Clearance Officer.
Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at
AHRQ has developed a systematic method for its grantees to report project progress and important preliminary findings for grants funded by the Agency. This system, the Grants Reporting System (GRS), was first approved by OMB on November 10, 2004. The system addressed the shortfalls in the previous reporting process and established a consistent and comprehensive grants reporting solution for AHRQ. The GRS provides a centralized repository of grants research progress and additional information that can be used to support initiatives within the Agency. This includes future research planning and support to administration activities such as performance monitoring, budgeting, knowledge transfer as well as strategic planning.
This Project has the following goals:
(1) To promote the transfer of critical information more frequently and efficiently and enhance the Agency's ability to support research designed to improve the outcomes and quality of health care, reduce its costs, and broaden access to effective services;
(2) To increase the efficiency of the Agency in responding to ad-hoc information requests; and
(3) To support Executive Branch requirements for increased transparency and public reporting;
(4) To establish a consistent approach throughout the Agency for information collection regarding grant progress and a systematic basis for oversight and for facilitating potential collaborations among grantees; and,
(5) To decrease the inconvenience and burden on grantees of unanticipated ad-hoc requests for information by the Agency in response to particular (one-time) internal and external requests for information.
Grants Reporting System—Grantees use the GRS to report project progress and important preliminary findings for grants funded by the Agency. Grantees submit a progress report on a quarterly basis which is reviewed by AHRQ personnel. All users access the GRS system through a secure online interface which requires a user id and password entered through the GRS Login screen. When status reports are due, AHRQ notifies Principle Investigators (PI) and Vendors via email.
The GRS is an automated user-friendly resource that is utilized by AHRQ staff for preparing, distributing, and reviewing reporting requests to grantees for the purpose of information sharing. AHRQ personnel are able to systematically search on the information collected and stored in the GRS database. Personnel will also use the information to address internal and/or external requests for information regarding grant progress, preliminary findings, and other requests, such as Freedom of Information Act requests, and producing responses related to federally mandated programs and regulations.
Exhibit 1 shows the estimated annualized burden hours for the respondents. It will take grantees an estimated 10 minutes to enter the necessary data into the Grant Reporting System (GRS) and reporting will occur four times annually. The total annualized burden hours are estimated to be 333 hours.
Exhibit 2 shows the estimated annualized cost burden for the respondents. The total estimated cost burden for respondents is $11,772.
In accordance with the above-cited Paperwork Reduction Act legislation, comments on AHRQ's information collection are requested with regard to any of the following: (a) whether the proposed collection of information is necessary for the proper performance of AHRQ healthcare research and healthcare information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.
Agency for Health care Research and Quality, HHS.
Notice.
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project:
This proposed information collection was previously published in the
Comments on this notice must be received by March 20, 2014.
Written comments should be submitted to: AHRQ's OMB Desk Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by email at
Copies of the proposed collection plans, data collection instruments, and specific details on the estimated burden can be obtained from the AHRQ Reports Clearance Officer.
Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at
As part of their effort to fulfill their mission goals, AHRQ, in collaboration with the Department of Defense's (DoD) Tricare Management Activity (TMA), developed TeamSTEPPS® (aka Team Strategies and Tools for Enhancing Performance and Patient Safety) to provide an evidence-based suite of tools and strategies for training teamwork-based patient safety to health care professionals. In 2007, AHRQ and DoD coordinated the national implementation of the TeamSTEPPS program. The main objective of this program is to improve patient safety by training a select group of stakeholders such as Quality Improvement Organization (QIO) personnel, High Reliability Organization (HRO) staff, and health care system staff in various teamwork, communication, and patient safety concepts, tools, and techniques and ultimately helping to build national capacity for supporting teamwork-based patient safety efforts in health care organizations and at the state level. The implementation includes the availability of voluntary training of Master Trainers in various health care systems capable of stimulating the utilization and adoption of TeamSTEPPS in their health care delivery systems, providing technical assistance and consultation on
To understand the extent to which this expanded patient safety knowledge and skills have been created, AHRQ will conduct an evaluation of the National Implementation of TeamSTEPPS Master Training program. The goals of this evaluation are to examine the extent to which training participants have been able to:
(1) Implement the TeamSTEPPS products, concepts, tools, and techniques in their home organizations and,
(2) spread that training, knowledge, and skills to their organizations, local areas, regions, and states.
This study is being conducted by AHRQ through its contractor, Health Research & Educational Trust (HRET), pursuant to AHRQ's statutory authority to conduct and support research on health care and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness and value of health care services and with respect to quality measurement and improvement. 42 U.S.C. 299a(a)(1) and (2).
To achieve the goals of this assessment the following two data collections will be implemented:
(1) Web-based questionnaire to examine post-training activities and teamwork outcomes as a result of training from multiple perspectives. The questionnaire is directed to all master training participants. Items will cover post-training activities, implementation experiences, facilitators and barriers to implementation encountered, and perceived outcomes as a result of these activities.
(2) Semi-structured interviews will be conducted with members from organizations who participated in the TeamSTEPPS Master Training program. Information gathered from these interviews will be analyzed and used to draft a “lessons learned” document that will capture additional detail on the issues related to participants' and organizations' abilities to implement and disseminate the TeamSTEPPS post-training. The organizations will vary in terms of type of organization (e.g., QIO or hospital associations versus health care systems) and region (i.e., Northeast, Midwest, Southwest, Southeast, Mid-Atlantic, and West Coast). In addition, we will strive to ensure representativeness of the sites by ensuring that the distribution of organizations mirrors the distribution of organizations in the master training population. For example, if the distribution of organizations is such that only one out of every five organizations is a QIO, we will ensure that a maximum of two organizations in the sample are QIOs. The interviews will more accurately reveal the degree of training spread for the organizations included. Interviewees will be drawn from qualified individuals serving in one of two roles (i.e., implementers or facilitators). The interview protocol will be adapted for each role based on the respondent group and to some degree, for each individual, based on their training and patient safety experience.
Exhibit 1 shows the estimated annualized burden hours for the respondent's time to participate in the study. Semi-structured interviews will be conducted with a maximum of 9 individuals from each of 9 participating organizations and will last about one hour each. The training participant questionnaire will be completed by approximately 10 individuals from each of about 240 organizations and is estimated to require 20 minutes to complete. The total annualized burden is estimated to be 881 hours.
Exhibit 2 shows the estimated annualized cost burden based on the respondents' time to participate in the study. The total cost burden is estimated to be $38,923.
In accordance with the above-cited Paperwork Reduction Act legislation, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ health care research and health care information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.
Agency for Healthcare Research and Quality (AHRQ), Department of Health and Human Services (HHS).
Notice of Availability—New Common Formats
As authorized by the Secretary of HHS, AHRQ coordinates the development of common definitions and reporting formats (Common Formats) for reporting patient safety events to Patient Safety Organizations (PSOs) and other entities. The purpose of this notice is to announce the availability of a new type of Common Formats for public review and comment—
Ongoing public input.
The newly released
Glenn Egelman, M.D., Center for Quality Improvement and Patient Safety, AHRQ, 540 Gaither Road, Rockville, MD 20850; Telephone (toll free): (866) 403-3697; Telephone (local): (301) 427-1111; TTY (toll free): (866) 438-7231; TTY (local): (301) 427-1130; Email:
The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to b-26, (Patient Safety Act) and the related Patient Safety and Quality Improvement Final Rule, 42 CFR Part 3 (Patient Safety Rule), published in the
The Patient Safety Act and Patient Safety Rule establish a framework by which doctors, hospitals, skilled nursing facilities, and other healthcare providers may assemble information regarding patient safety events and quality of care. Information that is assembled and developed by providers for reporting to PSOs and the information received and analyzed by PSOs—called patient safety work product—is privileged and confidential. Patient safety work product is used to conduct patient safety activities, which may include identifying events, patterns of care, and unsafe conditions that increase risks and hazards to patients. Definitions and other details about PSOs and patient safety work product are included in the Patient Safety Act and Patient Safety Rule which can be accessed electronically at:
The term Common Formats refers to the common definitions and reporting formats, specified by AHRQ, that allow healthcare providers to collect and submit standardized information regarding patient safety events. The Common Formats are not intended to replace any current mandatory reporting system, collaborative/voluntary reporting system, research-related reporting system, or other reporting/recording system; rather the formats are intended to enhance the ability of healthcare providers to report information that is standardized both clinically and electronically.
In collaboration with the interagency Federal Patient Safety Workgroup (PSWG), the National Quality Forum (NQF) and the public, AHRQ has developed Common Formats for two settings of care—acute care hospitals and skilled nursing facilities—in order to facilitate standardized data collection. The scope of Common Formats applies to all patient safety concerns including: Incidents—patient safety events that reached the patient, whether or not there was harm; near misses or close calls—patient safety events that did not reach the patient; and unsafe conditions—circumstances that increase the probability of a patient safety event.
Until now, Common Formats have been designed to support only traditional event reporting.
In anticipation of the need for Common Formats, AHRQ began their development by creating an inventory of functioning private and public sector patient safety reporting systems. This inventory provides an evidence base that informed construction of the Common Formats. The inventory includes many systems from the private sector, including academic settings, hospital systems, and international reporting systems (e.g., from the United Kingdom and the Commonwealth of
Since February 2005, AHRQ has convened the PSWG to assist AHRQ with developing and maintaining the Common Formats. The PSWG includes major health agencies within HHS—CDC, Centers for Medicare and Medicaid Services, FDA, Health Resources and Services Administration, Indian Health Service, National Institutes of Health, National Library of Medicine, Office of the National Coordinator for Health Information Technology, Office of Public Health and Science, and Substance Abuse and Mental Health Services Administration—as well as the DoD and VA.
When developing Common Formats, AHRQ first reviews existing patient safety event reporting systems from a variety of health care organizations. In collaboration with the PSWG and Federal subject matter experts, AHRQ drafts and releases beta versions of the Common Formats for public review and comment. The PSWG assists AHRQ with assuring the consistency of definitions/formats with those of relevant government agencies as refinement of the Common Formats continues. To the extent practicable, the Common Formats are also aligned with World Health Organization (WHO) concepts, framework, and definitions for patient safety.
To allow for greater participation by the private sector in the subsequent development of the Common Formats, AHRQ engaged the NQF, a non-profit organization focused on health care quality, to solicit comments and advice to guide the further refinement of the Common Formats. The NQF then convenes an expert panel to review the comments received and provide feedback. Based upon the expert panel's feedback, AHRQ, in conjunction with the PSWG, revises and refines the Common Formats.
The Agency is specifically interested in obtaining feedback from both the private and public sectors to guide the improvement of the formats. Information on how to comment and provide feedback on the
More information about the Common Formats can be obtained through AHRQ's PSO Web site:
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a collection of information entitled “Final Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes to be Documented in Annual Reports ” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, PRAStaff@fda.hhs.gov.
On November 6, 2013; the Agency submitted a proposed collection of information entitled “Final Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes to be Documented in Annual Reports” to OMB for review and clearance under 44 U.S.C. 3507. 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 OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0758. The approval expires on January 31, 2017. A copy of the supporting statement for this information collection is available on the Internet at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a collection of information entitled “Medical Devices; Third Party Review Under the Food and Drug Administration Modernization Act (FDAMA)” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850,
On December 19, 2013, the Agency submitted a proposed collection of information entitled “Medical Devices; Third Party Review Under FDAMA” to OMB for review and clearance under 44 U.S.C. 3507. 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 OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0375. The approval expires on January 31, 2017. A copy of the supporting statement for this information collection is available on the Internet at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the
Submit either electronic or written comments on the collection of information by April 21, 2014.
Submit electronic comments on the collection of information to
FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850,
Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act) (Pub. L. 111-31) into law. The Tobacco Control Act amended section 201
FDA created a Tobacco Call Center (with a toll-free number: 1-877-CTP-1373). Callers are able to report potential violations of the Tobacco Control Act, and FDA will conduct targeted followup investigations based on information received. When callers report a violation, the caller will be asked to provide as much certain information as they can recall, including: The date the potential violation occurred; product type (e.g., cigarette, smokeless, roll-your-own); tobacco brand; potential violation type; type of potentially violative promotional materials; who potentially violated; and the name, address, phone number, and email address of the potential violator. The caller will also be asked to list the potential violator's Web site (if available), describe the potential violation, and provide any additional files or information pertinent to the potential violation.
FDA currently provides a form that may be used to solicit this information from the caller (Form FDA 3779, Potential Tobacco Product Violations Report), and seeks renewal of Form FDA 3779. This form is posted on FDA's Web site. The public and interested stakeholders are also able to report information regarding possible violations of the Tobacco Control Act through the following methods: Calling the Tobacco Call Center using the Center for Tobacco Products' (CTP) toll-free number; using a fillable Form FDA 3779 found on FDA's Web site; downloading a PDF version of the form to send via email or mail to FDA; requesting a copy of Form FDA 3779 by contacting CTP and sending by mail to FDA; and sending a letter to FDA's CTP. The public and interested stakeholders will also be able to report information regarding possible violations of the Tobacco Control Act in the future using FDA's tobacco violation reporting smartphone application.
FDA estimates the burden of this collection of information as follows:
FDA estimates that submitting the information (by telephone, Internet, mail, smartphone application, or email) will take 0.25 hours (i.e., 15 minutes) per response. FDA estimates the number of annual respondents to this collection of information will be 400, who will each submit 2 reports by telephone, Internet, mail, smartphone application, or email. This estimate is based on the rate of reporting through Form FDA 3779, reports received from FDA's toll-free telephone number and email address, and FDA experience. Each report is expected to take 0.25 hours to complete and submit; therefore, total burden hours for this collection of information is estimated to be 200 hours (800 responses x 0.25 hours per response). The total burden hours for this collection have decreased by 50 hours (from 250 to 200) because the number of estimated respondents decreased from 1,000 to 400, and the annual responses are expected to drop from 1,000 to 800 annually. Based on past submissions to FDA, the number of estimated annual respondents is expected to decrease from 1,000 to 400 and each respondent's number of submissions is expected to increase from 1 to 2 annually. Therefore, the number of responses are expected to decrease from 1,000 to 800 annually (400 respondents x 2 responses).
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a collection of information entitled “Over-the-Counter Human Drugs; Labeling Requirements” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850,
On December 20, 2013; the Agency submitted a proposed collection of information entitled “Over-the-Counter Human Drugs; Labeling Requirements” to OMB for review and clearance under 44 U.S.C. 3507. 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 OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0340. The approval expires on January 31, 2017. A copy of the supporting statement for this information collection is available on the Internet at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the
Submit either electronic or written comments on the collection of information by April 21, 2014.
Submit electronic comments on the collection of information to
FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850,
Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)) authorizes the FDA to conduct research relating to health information. Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to conduct research relating to drugs and other FDA-regulated products in carrying out the provisions of the FD&C Act.
Prescription drug advertising regulations (21 CFR 202.1) require that broadcast (TV or radio) advertisements present the product's major risks in either audio or audio and visual parts of the advertisement; this is often called the “major statement.” There is concern that as currently implemented in DTC ads, the major statement is often too long, which may result in reduced consumer comprehension, minimization of important risk information and, potentially, therapeutic noncompliance due to fear of side effects. At the same time, there is concern that DTC TV ads do not include adequate risk information or leave out important information. These are conflicting viewpoints. A possible resolution is to limit the risks in the major statement to those that are serious and actionable, and include a disclosure to alert consumers that there are other product risks not included in the ad. For example, the disclosure could be, “This is not a full list of risks and side effects. Talk to your doctor and read the patient labeling for [drug name] before starting it.” The Office of Prescription Drug Promotion (or we) plans to investigate the effectiveness of this “limited risks plus disclosure” strategy through empirical research.
Our hypothesis is that, relative to inclusion of the full major statement, providing limited risk information along with the disclosure about additional risks will promote improved consumer perception and understanding of serious and actionable drug risks. We will also investigate other questions such as whether overall drug risk and benefit perceptions are affected by these changes. To examine differences between experimental conditions, we will conduct inferential statistical tests such as analysis of variance. With the sample size described below, we will have sufficient power to detect small- to medium-sized effects in the main study.
Participants will be consumers who self-identify as having been diagnosed with one of three possible medical conditions. All participants will be 18 years of age or older. We will exclude individuals who work in healthcare or marketing settings because their knowledge and experiences may not reflect those of the average consumer. Recruitment and administration of the study will take place over the Internet. Participation is estimated to take approximately 30 minutes.
Within medical condition, participants will be randomly assigned to view one of four possible versions of an ad, as depicted in table 1 below. One version will present the full major statement without the disclosure regarding additional risks (conditions C, G, and K). This version will implement existing ads in the marketplace. Stimuli variations for the other three versions will be achieved by replacing the audio track of the original ad with the revised risk and disclosure statements described above. Thus, a second version of the ad will include the full major statement plus the disclosure about additional risks (conditions A, E, and I). A third version will include an abbreviated statement of risks without the disclosure about additional risks (conditions G, H, and L). The fourth version will include an abbreviated statement of risks as well as the disclosure about additional risks (conditions B, F, and J).
After viewing the ad, participants will respond to questions about information in the ad. Preliminary measures are designed to assess perception and understanding of product risks and benefits; perception and understanding of the disclosure about additional risks; perceptions of product quality; intention to seek more information about the product; and perceptions of trust/skepticism regarding product claims and the sponsor. The questionnaire is available upon request.
FDA estimates the burden of this collection of information as follows:
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the
Submit either electronic or written comments on the collection of information by April 21, 2014.
Submit electronic comments on the collection of information to
FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850,
Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
Under the Public Health Service Act (PHS Act), the Department of Health and Human Services stockpiles medical products that are essential to the health security of the nation (see PHS Act, 42 U.S.C. 247d-6b). This collection of medical products for use during national health emergencies, known as the SNS, is to “provide for the emergency health security of the United States, including the emergency health security of children and other vulnerable populations, in the event of a bioterrorist attack or other public health emergency.”
It may be appropriate for certain medical products that are or will be held in the SNS to be labeled in a manner that would not comply with certain FDA labeling regulations given their anticipated circumstances of use in an emergency. However, noncompliance with these labeling requirements could render such products misbranded under section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352).
Under §§ 201.26, 610.68, 801.128, and 809.11 (21 CFR 201.26, 610.68, 801.128, and 809.11), the appropriate FDA Center Director may grant a request for an exception or alternative to certain regulatory provisions pertaining to the labeling of human drugs, biological products, medical devices, and in vitro diagnostics that currently are or will be included in the SNS if certain criteria are met. The appropriate FDA Center Director may grant an exception or alternative to certain FDA labeling requirements if compliance with these labeling requirements could adversely
Under § 201.26(b)(1)(i) (human drug products), § 610.68(b)(1)(i) (biological products), § 801.128(b)(1)(i) (medical devices), and § 809.11(b)(1)(i) (in vitro diagnostic products for human use), an SNS official or any entity that manufactures (including labeling, packing, relabeling, or repackaging), distributes, or stores such products that are or will be included in the SNS may submit, with written concurrence from an SNS official, a written request for an exception or alternative to certain labeling requirements to the appropriate FDA Center Director. Except when initiated by an FDA Center Director, a request for an exception or alternative must be in writing and must:
• Identify the specified lots, batches, or other units of the affected product;
• Identify the specific labeling provisions under this rule that are the subject of the request;
• Explain why compliance with the specified labeling provisions could adversely affect the safety, effectiveness, or availability of the product subject to the request;
• Describe any proposed safeguards or conditions that will be implemented so that the labeling of the product includes appropriate information necessary for the safe and effective use of the product given the anticipated circumstances of use of the product;
• Provide copies of the proposed labeling of the specified lots, batches, or other units of the affected product that will be subject to the exception or alternative; and
• Provide any other information requested by the FDA Center Director in support of the request.
If the request is granted, the manufacturer may need to report to FDA any resulting changes to the New Drug Application, Biologics License Application, Premarket Approval Application, or Premarket Notification (510(k)) in effect, if any. The submission and grant of an exception or an alternative to the labeling requirements specified in this rule may be used to satisfy certain reporting obligations relating to changes to product applications under 21 CFR 314.70 (human drugs), 21 CFR 601.12 (biological products), 21 CFR 814.39 (medical devices subject to premarket approval), or 21 CFR 807.81 (medical devices subject to 510(k) clearance requirements). The information collection provisions in §§ 314.70, 601.12, 807.81, and 814.39 have been approved under OMB control numbers 0910-0001, 0910-0338, 0910-0120, and 0910-0231 respectively. On a case-by-case basis, the appropriate FDA Center Director may also determine when an exception or alternative is granted that certain safeguards and conditions are appropriate, such as additional labeling on the SNS products, so that the labeling of such products would include information needed for safe and effective use under the anticipated circumstances of use.
Respondents to this collection of information are entities that manufacture (including labeling, packing, relabeling, or repackaging), distribute, or store affected SNS products. Based on the number of requests for an exception or alternative received by FDA in fiscal years 2012-13, FDA estimates an average of one request annually. FDA estimates an average of 24 hours preparing each request. The average burden per response for each submission is based on the estimated time that it takes to prepare a supplement to an application, which may be considered similar to a request for an exception or alternative. To the extent that labeling changes not already required by FDA regulations are made in connection with an exception or alternative granted under the final rule, FDA is estimating one occurrence annually in the event FDA would require any additional labeling changes not already covered by FDA regulations. FDA estimates 8 hours to develop and revise the labeling to make such changes. The average burden per response for each submission is based on the estimated time to develop and revise the labeling to make such changes.
FDA estimates the burden of this collection of information as follows:
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the
Submit either electronic or written comments on the collection of information by April 21, 2014.
Submit electronic comments on the collection of information to
FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850,
Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
The United States exports a large volume and variety of foods in international trade. For certain food products, foreign governments may require assurances from the responsible authority of the country of origin of an imported food that the processor of the food is in compliance with applicable country of origin regulatory requirements. With regard to U.S. milk products, FDA is the competent U.S. food safety authority to provide this information to foreign governments. We provide the requested information about processors in the form of lists. The lists are provided to the foreign governments and also posted online at
We currently provide Chile a list of U.S. milk product manufacturers/processors that have expressed interest in exporting their products to Chile, are subject to our jurisdiction, and are not the subject of a pending judicial enforcement action (i.e., an injunction or seizure) or a pending warning letter. In the
FDA was asked to provide a list to China in response to China's State General Administration of the People's Republic of China for Quality Supervision and Inspection and Quarantine (AQSIQ) issuance of Administrative Measures for Registration of Overseas Manufacturers, known as AQSIQ Decree 145. Accordingly, we established and maintain for China a list that identifies U.S. milk product manufacturers/processors that have expressed interest to us in exporting milk products to China, are subject to our jurisdiction, and are not the subject of a pending judicial enforcement action (i.e., an injunction or seizure) or a pending warning letter. On January 9, 2014, we issued a guidance document entitled, “Establishing and Maintaining a List of U.S. Milk Product Manufacturers/Processors with Interest in Exporting to China.” The guidance can be found at
As noted, we provided the new list to China in response to AQSIQ Decree 145. In accordance with 5 CFR 1320.13, FDA requested emergency OMB review and approval of the collections of information found in the guidance document. The routine course of OMB approval would not have been in the best interest of the public health because it would have delayed our ability to collect the information from firms and, thus, would have been disruptive in our efforts to facilitate services that have been requested by China in AQSIQ Decree 145. OMB granted the approval under the emergency clearance procedures on November 7, 2013.
The guidance documents are published under the authority of section 701(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)), which authorizes the Secretary to develop guidance documents with public participation presenting the views of the Secretary on matters under the jurisdiction of the FDA.
The guidance documents explain what information firms should submit to us in order to be considered for inclusion on the lists and what criteria we intend to use to determine eligibility for placement on the lists. The guidance documents also explain how we intend to update the list and how we intend to communicate any new information to the government that requested the list. Finally, the guidance documents note that the information is provided voluntarily by firms with the understanding that it will be posted on our Web site and communicated to, and possibly further disseminated by, the government that requested the list; thus, we consider the information on the lists to be information that is not protected from disclosure under 5 U.S.C. 552(b)(4).
Application for inclusion on each list is voluntary. In the guidance documents, we recommend that U.S. firms that want to be placed on either list send the following information to us: Name and address of the firm and the manufacturing plant; name, telephone number, and email address (if available) of the contact person; a list of products presently shipped and expected to be shipped in the next 3 years; identities of agencies that inspect the plant and the date of last inspection; plant number and copy of last inspection notice; and, if other than an FDA inspection, copy of last inspection report. We request that this information be updated every 2 years.
We use the information submitted by firms to determine their eligibility for placement on the list, which is published on our Web site. The purpose of the list is to help the governments of Chile and China in their determination of which U.S. milk product manufacturers are eligible to export to their respective countries.
FDA estimates the burden of this collection of information as follows:
The estimate of the number of firms that will submit new written requests to be placed on the list, biennial updates, and occasional updates is based on the FDA's experience maintaining the list over the past 8 years. The estimate of the number of hours that it will take a firm to gather the information needed to be placed on the list or update its information is based on FDA's experience with firms submitting similar requests. FDA believes that the information to be submitted will be readily available to the firms.
Based on submissions received for the Chile list over the past 3 years and the China list over the past 3 months, we estimate that, annually, an average of 100 new firms will submit written requests to be placed on the China list and 25 new firms will seek to be placed on the Chile list, reported as 125 total respondents on line 1 of table 1. We estimate that a firm will require 1.5 hours to read the guidance, to gather the information needed, and to prepare a communication to FDA that contains the information and requests that the firm be placed on the list, for a total of 187.5 burden hours, rounded to 188, as reported on line 1 of table 1. Under the guidance, every 2 years each firm on the list must provide updated information in order to remain on the list.
There are approximately 250 firms on the 2 lists combined. We estimate that, each year, approximately half of the firms on the list, 125 firms, will resubmit the information to remain on the list. We estimate that a firm already on the list will require 1 hour to biennially update and resubmit the information to us, including time reviewing the information and corresponding with us, for a total of 125 hours. In addition, we expect that, each year, approximately 50 firms will need to submit an occasional update and each firm will require 0.5 hours to prepare a communication to us reporting the change, for a total of 125 hours.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the
Submit either electronic or written comments on the collection of information by April 21, 2014.
Submit electronic comments on the collection of information to
FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850,
Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
FDA conducts focus group interviews on a variety of topics involving FDA-regulated products including, drugs, biologics, devices, food, tobacco, and veterinary medicine.
Focus groups provide an important role in gathering information because they allow for a more in-depth understanding of consumers' attitudes, beliefs, motivations, and feelings than do quantitative studies. Focus groups serve the narrowly defined need for direct and informal opinion on a specific topic and as a qualitative research tool have three major purposes:
• To obtain consumer information that is useful for developing variables and measures for quantitative studies,
• To better understand consumers' attitudes and emotions in response to topics and concepts, and,
• To further explore findings obtained from quantitative studies.
FDA will use focus group findings to test and refine their ideas, but will generally conduct further research before making important decisions such as adopting new policies and allocating or redirecting significant resources to support these policies.
FDA estimates the burden of this collection of information as follows:
Annually, FDA projects about 20 focus group studies using 160 focus groups with an average of 9 persons per group, and lasting an average of 1.75 hours each. FDA is requesting this burden for unplanned focus groups so as not to restrict the agency's ability to gather information on public sentiment of its proposals in its regulatory and communications programs.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a collection of information entitled “Animal Feed Regulatory Program Standards” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850,
On December 6, 2013; the Agency submitted a proposed collection of information entitled “Animal Feed Regulatory Program Standards” to OMB for review and clearance under 44 U.S.C. 3507. 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 OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0760. The approval expires on January 31, 2017. A copy of the supporting statement for this information collection is available on the Internet at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the
Submit either electronic or written comments on the collection of information by April 21, 2014.
Submit electronic comments on the collection of information to
FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850,
Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
Section 741 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 379j-21) establishes three different kinds of user fees: (1) Fees for certain types of abbreviated applications for generic new animal drugs; (2) annual fees for certain generic new animal drug products; and (3) annual fees for certain sponsors of abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs (21 U.S.C. 379j-21(a)). Because concurrent submission of user fees with applications is required, the review of an application cannot begin until the fee is submitted. Form FDA 3728 is the AGDUFA cover sheet, which is designed to provide the minimum necessary information to determine whether a fee is required for review of an application, to determine the amount of the fee required, and to account for and track user fees.
The Animal Generic Drug User Fee Amendments of 2013, signed by the President on June 13, 2013 (AGDUFA II) (Title II of Pub. L. 113-14), amended the FD&C Act authorizing FDA to collect user fees for certain abbreviated applications for generic new animal drugs, for certain generic new animal drug products, and for certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. To implement changes under the reauthorization by their effective date of October 1, 2013, FDA sought and received OMB approval to update its Form FDA 3728 as described here:
On page 1 of the electronic questions under “Select an Application Type” users must select “Original” and then choose either, “Abbreviated New Animal Drug Application (ANADA)—under provisions of 512(b)(2) of the FD&C Act (21 U.S.C. 360b(b)(2))”; or “Abbreviated New Animal Drug Application—for certain combination pioneer products approved under provisions of 512(d)(4) of the FD&C Act (21 U.S.C. 360b(d)(4)).” If they select the first ANADA type, they will be charged 100 percent of the application fee. If they select the second ANADA type, then they will be charged at rate of 50 percent of the original application fee. To facilitate the application process in this regard, on Form FDA 3728 we have added a line in Section 3 that allows applicants to select the option, “3.2 Original Abbreviated New Animal Drug Application—for certain combination pioneer products approved under provisions of 512(d)(4) of the FD&C Act.”
FDA estimates the burden of this collection of information as follows:
Respondents to this collection of information are generic animal drug applicants. Based on data for the past 3 years, FDA estimates there are approximately 20 submissions annually and a total of 3.2 burden hours.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined that STAVZOR (valproic acid) delayed-release capsules, 125 milligrams (mg), 250 mg, and 500 mg, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for valproic acid, delayed-release capsules, 125 mg, 250 mg, and 500 mg, if all other legal and regulatory requirements are met.
Na'Im R. Moses, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6223, Silver Spring, MD 20993-0002, 240-402-3990.
In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).
The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug.
STAVZOR (valproic acid) delayed-release capsules, 125 mg, 250 mg, and 500 mg, is the subject of NDA 22-152, held by Banner Pharmacaps Inc., and initially approved on July 29, 2008. STAVZOR is indicated for acute treatment of manic or mixed episodes associated with bipolar disorder (with or without psychotic features), monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures, adjunctive therapy in patients with multiple seizure types that include absence seizures, and prophylaxis of migraine headaches.
In a letter dated June 25, 2013, Banner Pharmacaps Inc. notified FDA that STAVZOR (valproic acid) delayed-release capsules, 125 mg, 250 mg, and 500 mg, was being discontinued, and FDA moved the drug product to the “Discontinued Drug Product List” section of the Orange Book.
Pharmaceutics International, Inc., submitted a citizen petition dated August 7, 2013 (Docket No. FDA-2013-P-0948), under 21 CFR 10.30, requesting that the Agency determine whether STAVZOR (valproic acid) delayed-release capsules, 125 mg, 250 mg, and 500 mg, was withdrawn from sale for reasons of safety or effectiveness.
After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that STAVZOR (valproic acid) delayed-release capsules, 125 mg, 250 mg, and 500 mg, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that STAVZOR (valproic acid) delayed-release capsules, 125 mg, 250 mg, and 500 mg, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of STAVZOR (valproic acid) delayed-release capsules, 125 mg, 250 mg, and 500 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have reviewed the available evidence and determined that product was not withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list STAVZOR (valproic acid) delayed-release capsules, 125 mg, 250 mg, and 500 mg, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to STAVZOR (valproic acid) delayed-release capsules, 125 mg, 250 mg, and 500 mg, may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) has determined
Amy Hopkins, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6207, Silver Spring, MD 20993-0002, 301-796-5418.
In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).
The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is generally known as the “Orange Book.” Under FDA regulations, a drug is removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).
Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved, and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if FDA determines that a listed drug was withdrawn from sale for safety or effectiveness reasons, the Agency will initiate proceedings that could result in the withdrawal of approval of the ANDAs that refer to the listed drug.
FDA has become aware that the drug products listed in the table in this document are no longer being marketed.
FDA has reviewed its records and, under § 314.161, has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list the drug products listed in this document in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” identifies, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness.
Approved ANDAs that refer to the NDAs and ANDAs listed in this document are unaffected by the discontinued marketing of the products subject to those NDAs and ANDAs. Additional ANDAs that refer to these products may also be approved by the Agency if they comply with relevant legal and regulatory requirements. If FDA determines that labeling for these drug products should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with
Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time.
Submit written requests for single copies of the guidance document entitled “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with FDA Staff” to the Division of Small Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301-847-8149. See the
Submit electronic comments on the guidance to
Program Operations Staff (IDE), Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-5640; or Elizabeth Hillebrenner, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5616, Silver Spring, MD 20993-0002, 301-796-6346; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, 301-827-6210.
Since its establishment in 1995, the pre-IDE program has been a successful resource for both medical device applicants and the FDA. Originally, this program was designed to provide applicants a mechanism to obtain FDA feedback on future IDE applications prior to their submission. Over time, the pre-IDE program evolved to include feedback on other device submission program areas, such as Premarket Approval (PMA) applications, Humanitarian Device Exemption applications, Evaluation of Automatic Class III Designations (de novo petitions), Premarket Notification (510(k)) Submissions, and Clinical Laboratory Improvement Amendments Waiver by Application, as well as to address questions related to whether a clinical study requires submission of an IDE.
The purpose of this guidance is to update the pre-IDE program to reflect this broader scope and make important modifications to reflect changes in the premarket program areas as a result of the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85). This guidance also further expands the scope of the program to include those devices regulated by CBER, including those that are regulated as biologics under the Public Health Service Act and require submission of an Investigational New Drug Application (IND) and/or a Biologics License Application. Accordingly, FDA is changing the name for this program from the pre-IDE program to the Pre-Submission (Pre-Sub) program.
Though successful, the Pre-Sub program has faced challenges, and the guidance is intended to address them and improve the Pre-Sub program by: (1) Describing the types of information that FDA would recommend submitting in order to get the best possible feedback from FDA; (2) outlining the process by which FDA meetings should be scheduled; and (3) explaining the Agency's expectations regarding advice given during the Pre-Sub process. This guidance outlines clear recommendations for sponsors and FDA staff.
In addition to the Pre-Sub program, the guidance addresses other types of FDA feedback already available to applicants through other mechanisms. The Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-115) established two types of formal early collaboration meetings (“determination meetings” as described in section 513(a)(3)(D) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and “agreement meetings” as described in section 520(g)(7) of the FD&C Act) to provide clear direction for testing and development of devices requiring clinical investigations to support marketing. FDAMA also requires that FDA, upon written request, must meet with a PMA applicant no later than 100 days after the receipt of a PMA application that has been filed to discuss the review status of the application (referred to as a “day-100 meeting” and described in section 515(d)(3) of the FD&C Act). For other premarket submissions under review, FDA will also grant meetings on an informal basis to discuss our requests for additional information to better ensure that the formal response to FDA's request will fully address the outstanding questions (these meetings are referred to as “submission issue meetings”). FDA will respond to requests for a determination (called “study risk determinations”) whether a proposed device study is exempt from or subject to the IDE regulation (21 CFR part 812). For device studies that are subject to the IDE regulations, FDA will also provide its determination whether the study is a significant risk or nonsignificant risk study in response to a voluntary request for this information. In some cases, sponsors may wish to inform or educate FDA about ongoing device development or planned submissions without a specific request for feedback. FDA will, as resources allow, grant requests for such “informational meetings.”
As part of the Medical Device User Fee Amendments of 2012 (MDUFA III), FDA committed to instituting a structured process for managing Pre-Subs. This final guidance establishes such a structured process for submission and management of Pre-Subs as well as other types of requests for feedback. In addition, the guidance describes how FDA will internally track these requests as “Q-Submissions,” or “Q-Subs,” including what types of submissions will be handled as supplements and amendments to an initial Q-Sub. FDA has also revised the optional CDRH Cover Sheet (Form FDA 3514) to include submission types that more closely track with the types of feedback requests discussed in the guidance.
FDA intends to provide the best possible advice in accordance with the information provided by the sponsor, to ensure it is captured accurately in the meeting minutes drafted by the sponsor,
Finally, the guidance describes the procedures that CDRH and CBER intend to follow when manufacturers, their representatives, or application sponsors request a meeting with review staff as the preferred method of feedback in response to a Pre-Sub, as an early collaboration meeting, or to discuss an existing regulatory submission. This guidance also recommends how to prepare for meetings with FDA staff.
In the
FDA received comments regarding the proposed timeframes for feedback to be provided to the applicant. Specifically, the guidance outlines a proposed target of 75 days, but generally no longer than 90 days, for feedback in response to a Pre-Sub. Comments requested that FDA modify the guidance to include a timeframe of 60 days for response to a Pre-Sub. As part of the MDUFA III Commitment Letter (Ref. 1), FDA agreed to improve the Pre-Sub process “as resources permit,” but, because there were no additional resources provided for this program as part of the overall MDUFA III program, the recommended timeframe for FDA feedback in a Pre-Sub represents the time in which FDA believes that feedback generally can be provided without the application of additional resources to this specific program.
Some comments expressed concern regarding FDA's recommendation that if more than 1 year has passed since our last feedback on key clinical trial design elements without a submission to the Agency, the sponsor should contact the review branch to confirm that the previous advice is still valid. The guidance has clarified that the reason for this recommendation is because clinical practice (including available alternative therapies or diagnostics) is rapidly evolving. The guidance has been further modified to clarify that a new Pre-Sub to the Agency is no longer recommended. Instead, confirmation that prior feedback is still valid can be accomplished through a phone call to the lead reviewer or branch chief.
In response to other minor substantive and editorial comments, FDA revised the guidance document to clarify the processes and policies as appropriate.
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency's current thinking on requests for FDA feedback, including the Pre-Sub program, and meetings with FDA staff. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.
Persons interested in obtaining a copy of the guidance may do so by using the Internet. A search capability for all CDRH guidance documents is available at
This guidance also refers to previously approved information collections found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 803 are approved under OMB control number 0910-0437; the collections of information in 21 CFR part 807, subpart E are approved under OMB control number 0910-0120; the collections of information in 21 CFR part 812 are approved under OMB control number 0910-0078; the collections of information in 21 CFR part 814 are approved under OMB control number 0910-0231; and the collections of information for Request for Feedback on Medical Device Submissions are approved under OMB control number 0910-0756.
Interested persons may submit either electronic comments to
The following reference is available electronically at
1. MDUFA III Commitment Letter, April 18, 2012, available at
Food and Drug Administration, HHS.
Notice of public conference.
The Food and Drug Administration (FDA) Cincinnati District, in cosponsorship with Xavier University, is announcing a public conference entitled “FDA/Xavier University PharmaLink Conference: Leadership in a Global Supply Chain.” The public conference seeks solutions to important and complicated issues by aligning with the strategic priorities of FDA, and includes presentations from key FDA officials, global regulators, and industry experts. Each presentation challenges the status quo and conventional wisdom to create synergies focused on finding solutions which make a difference. The experience level of the audience has fostered engaged dialog that has led to innovative initiatives.
The following forms of payment will be accepted: American Express, Visa, Mastercard, and company checks.
To register online for the public conference, please visit the “Registration” link on the conference Web site at
To register by mail, please send your name, title, firm name, address, telephone and fax numbers, email, and payment information for the fee to Xavier University, Attention: Matty Toomb, 3800 Victory Pkwy., Cincinnati, OH 45207. An email will be sent confirming your registration.
Attendees are responsible for their own accommodations. The conference headquarter hotel is the Downtown Cincinnati Hilton Netherlands Plaza, 35 West 5th Street, Cincinnati, OH 45202, 513-421-9100. To make reservations online, please visit the “Venue & Logistics” link at
If you need special accommodations due to a disability, please contact Marla Phillips (see Contact Persons) at least 7 days in advance of the conference.
The public conference helps fulfill the Department of Health and Human Services and FDA's important mission to protect the public health. The conference will engage those involved in FDA-regulated global supply chain quality and management through the following topics:
• The Impact of “The CDER Challenge” to Industry
• FDA and the Medicines and Healthcare Products Regulatory Agency (MHRA) Investigator Insights
• Operationalizing Effective Contract Partnerships
• Comparing Metrics with Other Companies—is There a Way? Why is it Vital?
• Complex Supply Chain Development
• The FDA Safety and Innovation Act (FDASIA): The New Frontier
• Why Your Incoming Supply is Not Reliable—Shifting Paradigms
• Innovation Versus Safety—The Impact of the Center for Drug Evaluation and Research's Restructure
• MHRA Perspective on Global Supply Chain Challenges
• How Did They Do That? Learn from Other Industries!
The conference includes:
• Networking by topic
• Case studies
• Small group discussions
• Action plans
• Keynote dinner at the Cincinnati Reds Baseball Stadium with the Chief Executive Officer of Patheon, James Mullen
The most pressing challenges of the global pharmaceutical industry require solutions which are inspired by collaboration to ensure the ongoing health and safety of patients. These challenges include designing products with the patient in mind, building quality into the product from the onset, selecting the right suppliers, and considering total product life-cycle systems. Meeting these challenges requires vigilance, innovation, supply chain strategy, relationship management, proactive change management, and a commitment to doing the job right the first time. FDA has made education of the drug and device manufacturing community a high priority to help ensure the quality of FDA-regulated drugs and devices.
The conference helps to achieve objectives set forth in section 406 of the Food and Drug Administration Modernization Act of 1997 (21 U.S.C. 393), which includes working closely with stakeholders and maximizing the availability and clarity of information to stakeholders and the public. The conference also is consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121) by providing outreach activities by Government Agencies to small businesses.
Food and Drug Administration, HHS.
Notice of meeting.
The Food and Drug Administration (FDA) is announcing the following meeting: 2014 Medical Countermeasures initiative (MCMi) Regulatory Science Symposium. The symposium is intended to provide a forum for the exchange of scientific ideas for medical countermeasure development and evaluation, communicate progress on regulatory science efforts related to the development and advancement of medical countermeasures, facilitate innovative directions, and inform stakeholders on medical countermeasure-related scientific progress and accomplishments.
There is no fee to register for the symposium and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited. If you need special accommodations due to a disability, please enter pertinent information in the “Notes” section of the electronic registration form when you register.
Food and Drug Administration, HHS.
Notice of availability.
Under the Food and Drug Administration Modernization Act of 1997 (FDAMA), the Food and Drug Administration (FDA) is required to report annually in the
Cathryn C. Lee, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6484, Silver Spring, MD 20993-0002, 301-796-0700; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852, 301-827-6210.
Section 130(a) of FDAMA (Pub. L. 105-115) amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by adding a new provision requiring reports of certain postmarketing studies, including clinical trials, for human drug and biological products (section 506B of the FD&C Act (21 U.S.C. 356b)). Section 506B of the FD&C Act provides FDA with additional authority to monitor the progress of a postmarketing study or clinical trial that an applicant has been required to, or has agreed to, conduct by requiring the applicant to submit a report annually providing information on the status of the postmarketing study/clinical trial. This report must also include reasons, if any, for failure to complete the study/clinical trial. These studies and clinical trials are intended to further define the safety, efficacy, or optimal use of a product, and therefore play a vital role in fully characterizing the product.
Under FDAMA, commitments to conduct postmarketing studies or clinical trials included both studies/clinical trials that applicants agreed to conduct, as well as studies/clinical trials that applicants were required to conduct under FDA regulations.
On September 27, 2007, the President signed Public Law 110-85, the Food and Drug Administration Amendments Act of 2007 (FDAAA). Section 901, in Title IX of FDAAA, created a new section 505(
Although regulations implementing FDAMA postmarketing authorities use
On October 30, 2000 (65 FR 64607), FDA published a final rule implementing section 130 of FDAMA. This rule modified the annual report requirements for new drug applications (NDAs) and abbreviated new drug applications (ANDAs) by revising § 314.81(b)(2)(vii) (21 CFR 314.81(b)(2)(vii)). The rule also created a new annual reporting requirement for biologics license applications (BLAs) by establishing § 601.70 (21 CFR 601.70). The rule described the content and format of the annual progress report, and clarified the scope of the reporting requirement and the timing for submission of the annual progress reports. The regulations became effective on April 30, 2001 (66 FR 10815). The regulations apply only to human drug and biological products approved under NDAs, ANDAs, and BLAs. They do not apply to animal drugs or to biological products regulated under the medical device authorities.
The reporting requirements under §§ 314.81(b)(2)(vii) and 601.70 apply to PMRs and PMCs made on or before the enactment of FDAMA (November 21, 1997), as well as those made after that date. Therefore, studies and clinical trials required under FDAAA are covered by the reporting requirements in these regulations.
Sections 314.81(b)(2)(vii) and 601.70 require applicants of approved drug and biological products to submit annually a report on the status of each clinical safety, clinical efficacy, clinical pharmacology, and nonclinical toxicology study/clinical trial either required by FDA or that they have committed to conduct, either at the time of approval or after approval of their NDA, ANDA, or BLA. The status of PMCs concerning chemistry, manufacturing, and production controls and the status of other studies/clinical trials conducted on an applicant's own initiative are not required to be reported under §§ 314.81(b)(2)(vii) and 601.70 and are not addressed in this report. It should be noted, however, that applicants are required to report to FDA on these commitments made for NDAs and ANDAs under § 314.81(b)(2)(viii). Furthermore, section 505(
According to the regulations, once a PMR has been required, or a PMC has been agreed upon, an applicant must report on the progress of the PMR/PMC on the anniversary of the product's approval
• Pending: The study/clinical trial has not been initiated (i.e., no subjects have been enrolled or animals dosed), but does not meet the criteria for delayed (i.e., the original projected date for initiation of subject accrual or initiation of animal dosing has not passed);
• Ongoing: The study/clinical trial is proceeding according to or ahead of the original schedule;
• Delayed: The study/clinical trial is behind the original schedule;
• Terminated: The study/clinical trial was ended before completion, but a final report has not been submitted to FDA; or
• Submitted: The study/clinical trial has been completed or terminated, and a final report has been submitted to FDA.
Databases containing information on PMRs/PMCs are maintained at the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
This report, published to fulfill the annual reporting requirement under FDAMA, summarizes the status of PMRs and PMCs as of September 30, 2012. If a requirement or commitment did not have a schedule, or a postmarketing progress report was not received in the previous 12 months, the PMR/PMC is categorized according to the most recent information available to the Agency.
Information in this report covers any PMR/PMC that was made, in writing, at the time of approval or after approval of an application or a supplement to an application, including PMRs required under FDAAA (section 505(
Information summarized in this report includes the following: (1) The number of applicants with open PMRs/PMCs, (2) the number of open PMRs/PMCs, (3) FDA-verified status of open PMRs/PMCs reported in § 314.81(b)(2)(vii) or § 601.70 annual reports, (4) the status of concluded PMRs/PMCs as determined by FDA, and (5) the number of applications for which an annual report was expected, but was not submitted within 60 days of the anniversary date of U.S. approval or an alternate reporting date that has been granted by FDA.
Additional information about PMRs/PMCs is provided on FDA's Web site at
An applicant may have multiple approved products, and an approved product may have multiple PMRs and/or PMCs. As of September 30, 2012, there were 172 unique applicants with 1,069 open PMRs/PMCs under 476 unique NDAs/ANDAs.
Applicants must submit an annual status report on the progress of each open PMR/PMC within 60 days of the anniversary date of U.S. approval of the original application or an alternate reporting date that has been granted by FDA. There were 432 NDAs/ANDAs with an annual status report due in fiscal year (FY) 2012.
For BLAs, there were 101 annual status reports expected in FY2012. Of those expected, 68 percent (69/101) were received on time; 12 percent (12/101) were received, but not on time; and 20 percent (20/101) were not received at any time during FY2012.
This report provides six separate summary tables. The tables in this document distinguish between PMRs and PMCs and between on-schedule and off-schedule PMRs and PMCs according to the original schedule milestones. On-schedule PMRs/PMCs are categorized as pending, ongoing, or submitted. Off-schedule PMRs/PMCs that have missed one of the original milestone dates are categorized as delayed or terminated. The tables include data as of September 30, 2012.
Table 1 of this document provides an overall summary of the data on all PMRs and PMCs. Tables 2 and 3 of this document provide detail on PMRs. Table 2 of this document provides additional detail on the status of on-schedule PMRs.
Table 1 of this document shows that most open PMRs (81 percent for NDAs/ANDAs and 83 percent for BLAs) and most open PMCs (73 percent for NDAs/ANDAs and 76 percent for BLAs) are progressing on schedule (i.e., are not delayed or terminated). Overall, of the PMRs that are pending (i.e., have not been initiated, but do not meet the definition for delayed), 78 percent (411/527) were created within the past 3 years.
Table 2 of this document shows that 53 percent (260/527) of pending PMRs for drug and biological products are in response to the Pediatric Research and Equity Act (PREA), under which FDA requires sponsors to study new drugs, when appropriate, for pediatric populations. Under section 505B(a)(3) (21 U.S.C. 355c(a)(3)) of the FD&C Act, the initiation of these studies generally is deferred until required safety information from other studies has first been submitted and reviewed. PMRs for products approved under the animal efficacy rule (21 CFR 314.600 for drugs; 21 CFR 601.90 for biological products) can be conducted only when the product is used for its indication as a counterterrorism measure. In the absence of a public health emergency, these studies/clinical trials will remain pending indefinitely. The next largest category of pending PMRs for drug and biological products (45 percent, 253/527) comprises those studies/clinical trials required by FDA under FDAAA, which became effective on March 25, 2008.
Table 3 of this document provides additional detail on the status of off-schedule PMRs. The majority of off-schedule PMRs (which account for 19 percent of the total for NDAs/ANDAs and 17 percent for BLAs) are delayed according to the original schedule milestones (98 percent (141/144) for NDAs/ANDAs; 93 percent (26/28) for BLAs). In certain situations, the original schedules may have been adjusted for unanticipated delays in the progress of the study/clinical trial (e.g., difficulties with subject enrollment in a trial for a marketed drug or need for additional time to analyze results). In this report, study/clinical trial status reflects the status in relation to the original study/clinical trial schedule regardless of whether FDA has acknowledged that additional time may be required to complete the study/;clinical trial.
Tables 4 and 5 of this document provide additional detail on the status of PMCs. Table 4 of this document provides additional detail on the status of on-schedule PMCs. Pending PMCs comprise 52 percent (111/215) of the on-schedule NDA/ANDA PMCs and 40 percent (79/200) of the on-schedule BLA PMCs.
Table 5 of this document provides additional details on the status of off-schedule PMCs. The majority of off-schedule PMCs (which account for 27 percent for NDAs/ANDAs and 24 percent for BLAs) are delayed according to the original schedule milestones (92 percent (72/78) for NDAs/ANDAs; 97 percent (61/63) for BLAs).
Table 6 of this document provides details about PMRs and PMCs that were concluded in FY2012. The majority of concluded PMRs and PMCs were fulfilled (67 percent of NDA/ANDA PMRs and 63 percent of BLA PMRs; 58 percent of NDA/ANDA PMCs and 85 percent of BLA PMCs).
Health Resources and Services Administration, HHS.
Notice.
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Comments on this Information Collection Request must be received within 60 days of this notice.
Submit your comments to
To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email
When submitting comments or requesting information, please include the information request collection title for reference.
The overarching goal is to increase the number of eligible individuals educated about their coverage options and enrollees to the Health Insurance Marketplaces or other available sources of insurance, such as Medicare, Medicaid, and the Children's Health Insurance Program as a result of this supplemental funding.
Total Estimated Annualized burden hours:
HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
In accordance with section 10(a)(2) of the Federal Advisory Committee Act
The ACCV will meet on Thursday, March 6, 2014, 1:00 p.m. to 4:15 p.m. EDT and Friday, March 7, 2014, 9:00 a.m. to 12:00 p.m. EDT. The public can join the meeting by:
1. (In Person) Persons interested in attending the meeting [in person] are encouraged to submit a written notification to: Annie Herzog, DVIC, Healthcare Systems Bureau (HSB), Health Resources and Services Administration (HRSA), Room 11C-26, 5600 Fishers Lane, Rockville, Maryland 20857 or email:
2. (Audio Portion) Calling the conference phone number, 877-917-4913, and providing the following information:
3. (Visual Portion) Connecting to the ACCV Adobe Connect Pro Meeting using the following URL:
Anyone requiring information regarding the ACCV should contact Annie Herzog, DVIC, HSB, HRSA, Room 11C-26, 5600 Fishers Lane, Rockville, MD 20857; telephone (301) 443-6634 or email:
National Institutes of Health, HHS.
Notice.
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: 301-496-7057; fax: 301-402-0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications.
This device includes a software program that allows a user to select prerecorded sounds for playback. The program will also generate an inverse model of the playback system in the form of a digital filter. The inverse model processes a selected sound to cancel the distortions of the playback system so the sound is accurately reproduced. The program also permits the extraction of a specific sound component from a prerecorded sound so only the extracted sound component is audible during playback. In addition to the obvious role of a teaching tool for medical professionals, this invention could have applications as a diagnostic screening and/or telemedicine tool.
The enterovirus molecular diagnostic test is prepared in a kit form, consisting of three reagent preparations (three separate test steps), to which a technician adds enzymes and RNA extracted from a clinical specimen. This format is amenable to commercial manufacturing processes. The assay primers were designed for broad specificity and amplify all recognized enterovirus serotypes. In the course of assay development, PCR products have been successfully amplified and sequenced from cerebrospinal fluid, nasopharyngeal swabs, eye swabs, rectal swabs and stool suspensions, allowing for unambiguous identification of the infecting virus in all cases. This assay will be useful for the diagnosis of numerous common illnesses, such as foot-and-mouth disease, respiratory illness, conjunctivitis, neonatal illness, and myocarditis, among several others.
• Screening elderly patients before beginning anti-inflammatory and/or anti-arthritis therapy
Current methods require expensive instantaneous and short-term monitors or gravimetric filters that must be carefully pre- and post-weighed to determine the average dust exposure of a user's work-shift. This novel dust dosimeter fills the need for an inexpensive short-term determination of personal dust exposure aiding in the assessment and preservation of worker respiratory health.
• Gas detector tube platform makes commercialization of this instrument
• Standardizing detection platforms increases cost-efficiency (especially for smaller companies) as the same pump can be used to measure both dust and gas
This technology encompasses polypeptide sequences that are specifically recognized by anti-
• Clinical serological diagnostics development
• PCT Application No. PCT/US2001/003584 filed 02 Feb 2001, which published as WO 2001/075448 on 11 Oct 2011
By correlating user activity to seal sensor data, a precise understanding and awareness of respirator integrity may be obtained. When coupled with a subject alarm, these integrated values can immediately alert a user when a threshold of environmental exposure has been reached. Such real-time feedback will be invaluable to users in dangerous occupational activities, such as firefighters, biodefense and chemical spill first responders, mining applications, etc. Additionally, this invention possesses immense value for respirator mask manufacturers and workplace training programs for employees engaged in mandatory respirator usage applications.
Performance of this PSP is not degraded by pump inertia or low flow size selective sampling errors. This
• In situ data available (on-site)
CDC-NIOSH researchers found that this technology improved accuracy and efficiency of ladder positioning for both “experienced” and “novice” ladder users, as compared to the “no instruction” method and the standard anthropometric method, and that it was also significantly faster than the bubble indicator method. When properly implemented, this effective and easy to use ladder positioning indicator will
Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Recombinant DNA Advisory Committee.
The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
Information is also available on the Institute's/Center's home page:
OMB's “Mandatory Information Requirements for Federal Assistance Program Announcements” (45 FR 39592, June 11, 1980) requires a statement concerning the official government programs contained in the Catalog of Federal Domestic Assistance. Normally NIH lists in its announcements the number and title of affected individual programs for the guidance of the public. Because the guidance in this notice covers virtually every NIH and Federal research program in which DNA recombinant molecule techniques could be used, it has been determined not to be cost effective or in the public interest to attempt to list these programs. Such a list would likely require several additional pages. In addition, NIH could not be certain that every Federal program would be included as many Federal agencies, as well as private organizations, both national and international, have elected to follow the NIH Guidelines. In lieu of the individual program listing, NIH invites readers to direct questions to the information address above about whether individual programs listed in the Catalog of Federal Domestic Assistance are affected.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.) notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Notice is hereby given of a change in the meeting of the National Cancer Institute Special Emphasis Panel, March 17, 2014, 09:00 a.m. to March 17, 2014, 12:30 p.m., National Cancer Institute Shady Grove, 2W914, Rockville, MD which was published in the
This meeting is being amended to change the start and end time to 12:00 p.m.-5:00 p.m. The meeting is closed to the public.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following 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.
Division of Scientific Review, National Institutes of Health, Eunice Kennedy Shriver National Institute, of Child Health and Human Development, 1600 Executive Boulevard, RM. 5B01, Bethesda, MD 20892, (301) 435-8382,
Notice is hereby given of a change in the meeting of the National Advisory Environmental Health Sciences Council, February 19, 2014, 08:30 a.m. to February 20, 2014, 11:00 p.m., Nat. Inst. of Environmental Health Sciences, Building 101, Rodbell Auditorium, 111 T.W. Alexander Drive, Research Triangle Park, NC 27709, which was published in the
This
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Board of Scientific Counselors, NIDCD.
The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the National Institute on Deafness and Other Communication Disorders, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Information is also available on the Institute's/Center's home page:
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Notice is hereby given of a change in the meeting of the National Cancer Advisory Board, February 26, 2014, 06:00 p.m. to February 27, 2014, 05:00 p.m., National Institutes of Health, Building 31, 31 Center Drive, Bethesda, MD, 20892 which was published in the
The meeting notice is amended to change the start and end time of the Subcommittee meeting on Planning and Budget, and to change the start time of
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Information is also available on the Institute's Center's home page:
Notice is hereby given of a change in the meeting of the National Cancer Institute Special Emphasis Panel, March 20, 2014, 07:00 p.m. to March 21, 2014, 04:00 p.m., Courtyard Marriott Washingtonian Center, 204 Boardwalk Place, Gaithersburg, MD 20878 which was published in the
The meeting notice is amended to change the location and time to 9609 Medical Center Drive, Room 5E30, Rockville, MD 20850, March 20, 2014, 10:00 a.m. to March 21, 2014, 3:30 p.m. Additionally the meeting is being held as a teleconference. The meeting is closed to the public.
National Institutes of Health, HHS.
Notice.
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive evaluation option license to practice the inventions covered under the scope of the following patents and patent applications:
• United States Patent No. 8,207,142 issued Jun 26, 2012 entitled “Inhibitor of DNA Methylation” (HHS Ref. No. E-081-2001/2-US-06);
• EP Patent No. 1418949 issued June 19, 2013, entitled “Inhibitor of DNA Methylation” (HHS Ref. No. E-081-2001/2-EP-02) and validated in Great Britain, Germany and France;
• Australia Patent No. 2002322805 issued February 21, 2008 entitled “Inhibitor of DNA Methylation” (HHS Ref. No. E-081-2001/2-AU-03);
• Australia Patent No. 2008200601 issued November 25, 2010 entitled “Inhibitor of DNA Methylation” (HHS Ref. No. E-081-2001/2-AU-07);
• Canada Patent No. 2,454,147 issued May 21, 2013 entitled “Inhibitor of DNA Methylation” (HHS Ref. No. E-081-2001/2-CA-04);
• Japan Patent Application No. 2003-517229 filed July 30, 2002 entitled “Inhibitor of DNA Methylation” (HHS Ref. No. E-081-2001/2-JP-05); and
• Japan Patent No. 5416660 issued November 22, 2013 entitled “Inhibitor of DNA Methylation” (HHS Ref. No. E-081-2001/2-JP-08)
The prospective exclusive evaluation option license territory may be
Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before March 5, 2014 will be considered.
Requests for copies of the patent application, inquiries, comments, and other materials relating to the contemplated exclusive evaluation option license should be directed to: Sabarni K. Chatterjee, Ph.D., M.B.A. Licensing and Patenting Manager, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: (301) 435-5587; Facsimile: (301) 402-0220; Email:
The present inventions relate to a potent inhibitor of DNA methylation (Zebularine) that can specifically reactivate silenced tumor suppressor genes. This agent can be used to inhibit methylation and thereby combat certain cancers that have been linked to hypermethylation. This agent has also been shown in initial animal testing to be active orally and is more stable than some other agents in this same area of therapy and is a suitable candidate for further pre-clinical and clinical development as an anti-cancer agent to be used as monotherapy and/or as an adjunct to existing anti-cancer therapeutics.
METHEOR has indicated its interest in developing Zebularine as novel epigenetic modifiers and drugs for oncologic indications
The prospective exclusive evaluation option license is being considered under the small business initiative launched on October 1, 2011 and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive evaluation option license, and a subsequent exclusive patent commercialization license, may be granted unless within fifteen (15) days from the date of this published notice, the NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.
Any additional, properly filed, and complete applications for a license in the field of use filed in response to this notice will be treated as objections to the grant of the contemplated exclusive evaluation option license. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.
Advisory Council on Historic Preservation.
Notice of Advisory Council on Historic Preservation Quarterly Business Meeting.
Notice is hereby given that the Advisory Council on Historic Preservation (ACHP) will hold its next quarterly meeting on Friday, March 7, 2014. The meeting will be held in Room SR325 at the Russell Senate Office Building at Constitution and Delaware Avenues NE., Washington, DC, starting at 8:30 a.m.
The quarterly meeting will take place on Friday, March 7, 2014, starting at 8:30 a.m. EST.
The quarterly meeting will be held in Room SR325 at the Russell Senate Office Building at Constitution and Delaware Ave. NE., Washington, DC.
Cindy Bienvenue, 202-606-8521,
The Advisory Council on Historic Preservation (ACHP) is an independent federal agency that promotes the preservation, enhancement, and sustainable use of our nation's diverse historic resources, and advises the President and the Congress on national historic preservation policy. The goal of the National Historic Preservation Act (NHPA), which established the ACHP in 1966, is to have federal agencies act as responsible stewards of our nation's resources when their actions affect historic properties. The ACHP is the only entity with the legal responsibility to encourage federal agencies to factor historic preservation into federal project requirements. For more information on the ACHP, please visit our Web site at
The agenda for the upcoming quarterly meeting of the ACHP is the following:
The meetings of the ACHP are open to the public. If you need special accommodations due to a disability, please contact Cindy Bienvenue, 202-606-8521 or
16 U.S.C. 470j.
Federal Emergency Management Agency, DHS.
Notice.
The Federal Emergency Management Agency, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on an extension, without change, of a currently approved information collection. In accordance with the Paperwork Reduction Act of 1995, this notice seeks comments concerning the collection of information necessary to allow States to request an exemption from maintaining flood insurance on State-owned structures.
Comments must be submitted on or before April 21, 2014.
To avoid duplicate submissions to the docket, please use only one of the following means to submit comments:
(1)
(2)
All submissions received must include the agency name and Docket ID. Regardless of the method used for submitting comments or material, all submissions will be posted, without change, to the Federal eRulemaking Portal at
Contact Mary Ann Chang, Insurance Examiner, Federal Insurance and Mitigation Administration, DHS/FEMA, at (202) 646-2714 for further information. You may contact the Records Management Division for copies of the proposed collection of information at facsimile number (202) 646-3347 or email address:
The Flood Disaster Protection Act of 1973 (Act), as amended, 42 U.S.C. 4001
•
Comments may be submitted as indicated in the
Federal Emergency Management Agency, DHS.
Notice.
The Federal Emergency Management Agency, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on a revision of a currently approved information collection. In accordance with the Paperwork Reduction Act of 1995, this notice seeks comments concerning the collection of information related to disaster program accounts and debts receivable.
Comments must be submitted on or before April 21, 2014.
To avoid duplicate submissions to the docket, please use only one of the following means to submit comments:
(1)
(2)
All submissions received must include the agency name and Docket ID. Regardless of the method used for submitting comments or material, all submissions will be posted, without change, to the Federal eRulemaking Portal at
Contact Mary Schneider, Chief, Debt Management Unit, FEMA Finance Center, Office of the Chief Financial Officer, FEMA, at (540) 504-1649 for further information. You may contact the Records Management Division for copies of the proposed collection of information at facsimile number (202) 646-3347 or email address:
Under the Debt Collection Improvement Act as amended (31 U.S.C. 3701,
Comments may be submitted as indicated in the
Federal Emergency Management Agency, DHS.
Notice.
The Federal Emergency Management Agency (FEMA) will submit the information collection abstracted below to the Office of Management and Budget for review and clearance in accordance with the requirements of the Paperwork Reduction Act of 1995. The submission will describe the nature of the information collection, the categories of respondents, the estimated burden (i.e., the time, effort and resources used by respondents to respond) and cost, and the actual data collection instruments FEMA will use.
Comments must be submitted on or before March 20, 2014.
Submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to the Desk Officer for the Department of Homeland Security, Federal Emergency Management Agency, and sent via electronic mail to
Requests for additional information or copies of the information collection should be made to Director, Records Management Division, 1800 South Bell Street, Arlington, VA 20598-3005, facsimile number (202) 646-3347, or email address:
Transportation Security Administration, DHS.
30-day notice.
This notice announces that the Transportation Security Administration (TSA) has forwarded the Information Collection Request (ICR), Office of Management and Budget (OMB) control number 1652-0044, abstracted below to OMB for review and approval of an extension of the currently approved collection under the Paperwork Reduction Act (PRA). The ICR describes the nature of the information collection and its expected burden. TSA published a
Send your comments by March 20, 2014. A comment to OMB is most effective if OMB receives it within 30 days of publication.
Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory
Joanna Johnson, TSA PRA Officer, Office of Information Technology (OIT), TSA-11, Transportation Security Administration, 601 South 12th Street, Arlington, VA 20598-6011; telephone (571) 227-3398; email
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
(1) Evaluate whether the proposed information requirement is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including using appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
The DHS TRIP office serves as a centralized intake office for traveler requests for redress and uses the online Traveler Inquiry Form (TIF) to collect requests for redress. DHS TRIP then passes the information to the relevant DHS component to process the request, as appropriate (
DHS estimates that completing the Traveler Inquiry Form, including gathering and submitting the information, will take approximately one hour. The annual respondent population was derived from data contained within the DHS case management database and reflects the projected number of respondents in the next fiscal year. Thus, the total estimated annual number of burden hours for passengers seeking redress, based on 15,000 annual respondents, is 15,000 hours (15,000 x 1).
30-Day Notice.
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection notice was previously published in the
The purpose of this notice is to allow an additional 30 days for public comments. Comments are encouraged and will be accepted until March 20, 2014. This process is conducted in accordance with 5 CFR 1320.10.
Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, must be directed to the OMB USCIS Desk Officer via email at
Regardless of the method used for submitting comments or material, all submissions will be posted, without change, to the Federal eRulemaking Portal at
The address listed in this notice should only be used to submit comments concerning this information collection. Please do not submit requests for individual case status inquiries to this address. If you are seeking information about the status of your individual case, please check “My Case Status” online at:
Written comments and suggestions from the public and affected agencies should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.
(1)
(2)
(3)
(4)
(5)
• E-Verify Self Check—Identity Authentication 2,900,000 responses at 0.0833 hours (5 minutes) per response;
• E-Verify Self Check—Query 2,175,000 responses at 0.0833 hours (5 minutes) per response;
• E-Verify Self Check—Further Action Pursued 5,582 responses at 1.183 hours (1 hour and 11 minutes) per response; and
• myE-Verify Account Creation 14,846 responses at 0.25 hours (15 minutes) per response.
(6)
If you need a copy of the information collection instrument with supplementary documents, or need additional information, please visit
Office of the Chief Information Officer, HUD.
Notice.
HUD has submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503; fax: 202-395-5806. Email:
Colette Pollard, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410; email Colette Pollard at
This notice informs the public that HUD has submitted to OMB a request for approval of the information collection described in Section A. The
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:
(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
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapters 35.
Office of the Chief Information Officer, HUD.
Notice.
HUD has submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503; fax: 202-395-5806. Email:
Colette Pollard, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410; email Colette Pollard at
This notice informs the public that HUD has submitted to OMB a request for approval of the information collection described in Section A. The
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:
(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; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. HUD encourages interested parties to submit comment in response to these questions.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapters 35.
Office of the Chief Information Officer, HUD.
Notice.
HUD has submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503; fax: 202-395-5806. Email:
Colette Pollard, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street, SW., Washington, DC 20410; email Colette Pollard at
This notice informs the public that HUD has submitted to OMB a request for approval of the information collection described in Section A. The
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:
(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; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. HUD encourages interested parties to submit comment in response to these questions.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapters 35.
Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD.
Notice.
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Colette Pollard, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street, SW., Room 4176, Washington, DC 20410-5000; telephone 202-402-3400 (this is not a toll-free number) or email at
Colette Pollard, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street, SW., Room 4176, Washington, DC 20410-5000; telephone 202-402-3400 (this is not a toll-free number) or email at
This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:
(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;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.
HUD encourages interested parties to submit comment in response to these questions.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.
Office of the Assistant Secretary for Housing-Federal Housing Commissioner, HUD.
Notice.
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Colette Pollard, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW., Room 4176, Washington, DC 20410-5000; telephone 202-402-3400 (this is not a toll-free number) or email at
Harry Messner, Project Manager, Field Asset Management Division, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410; email Harry Messner at
Copies of available documents submitted to OMB may be obtained from Mr. Messner.
This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:
(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;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.
HUD encourages interested parties to submit comment in response to these questions.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.
Office of the Chief Information Officer, HUD.
Notice.
HUD has submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503; fax: 202-395-5806. Email:
Colette Pollard, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street, SW., Washington, DC 20410; email Colette Pollard at
This notice informs the public that HUD has submitted to OMB a request for approval of the information collection described in Section A. The
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:
(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; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. HUD encourages interested parties to submit comment in response to these questions.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapters 35.
Office of the Assistant Secretary for Public and Indian Housing, PIH, HUD.
Notice of revised proposed information collection.
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.
The public housing program funds low-rent projects owned and operated by public housing agencies (PHAs), subject to the terms and conditions contained in an Annual Contributions Contract (ACC) with certain requirements applicable to all projects and other requirements applicable in only certain conditions or types of projects. These program requirements govern how properties are funded and operated by PHAs including how properties are added or removed from their inventories. Information collections from PHAs assure compliance with all Federal program requirements.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Colette Pollard, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW., Room 4176, Washington, DC 20410-5000; telephone 202-402-5564 (this is not a toll-free number) or email at
Arlette Mussington, Office of Policy, Programs and Legislative Initiatives, PIH, Department of Housing and Urban Development, 451 7th Street SW., (L'Enfant Plaza, Room 2206), Washington, DC 20410; telephone 202-402-4109, (this is not a toll-free number). Persons with hearing or speech impairments may access this number via TTY by calling the Federal Information Relay Service at (800) 877-8339. Copies of available documents submitted to OMB may be obtained from Ms. Mussington.
This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:
(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;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.
HUD encourages interested parties to submit comment in response to these questions.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.
Office of Assistant Secretary for Policy Development and Research, HUD.
Notice of Fiscal Year (FY) 2014 Annual Adjustment Factors (AAFs).
The United States Housing Act of 1937 requires that assistance contracts signed by owners participating in the Department's Section 8 housing assistance payment programs provide annual adjustments to monthly rentals for units covered by the contracts. This notice announces FY 2014 AAFs for adjustment of contract rents on assistance contract anniversaries. The factors are based on a formula using residential rent and utility cost changes from the most recent annual Bureau of Labor Statistics Consumer Price Index (CPI) survey. Beginning with the FY 2014 Fair Market Rents and continuing with the FY 2014 AAFs, the Puerto Rico CPI is used in place of the South Region CPI for all areas in Puerto Rico. These factors are applied at Housing Assistance Payment (HAP) contract anniversaries for those calendar months commencing after the effective date of this notice. A separate
Contact Michael S. Dennis, Director, Housing Voucher Programs, Office of Public Housing and Voucher Programs, Office of Public and Indian Housing, 202-708-1380, for questions relating to the Project-Based Certificate and Moderate Rehabilitation programs (non-Single Room Occupancy); Ann Oliva, Director, Office of Special Needs Assistance Programs, Office of Community Planning and Development, 202-708-4300, for questions regarding the Single Room Occupancy (SRO) Moderate Rehabilitation program; Catherine Brennan, Director, Office of Housing Assistance and Grant Administration, Office of Housing, 202-708-3000, for questions relating to all other Section 8 programs; and Marie Lihn, Economist, Economic and Market Analysis Division, Office of Policy Development and Research, 202-402-5866, for technical information regarding the development of the schedules for specific areas or the methods used for calculating the AAFs. The mailing address for these individuals is: Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410. Hearing- or speech-impaired persons may contact the Federal Information Relay Service at 800-877-8339 (TTY). (Other than the “800” TTY number, the above-listed telephone numbers are not toll free.)
Tables showing AAFs will be available electronically from the HUD data information page at
AAFs established by this Notice are used to adjust contract rents for units assisted in certain Section 8 housing assistance payment programs during the initial (i.e., pre-renewal) term of the HAP contract and for all units in the Project-Based Certificate program. There are three categories of Section 8 programs that use the AAFs:
Category 1: The Section 8 New Construction, Substantial Rehabilitation, and Moderate Rehabilitation programs;
Category 2: The Section 8 Loan Management (LM) and Property Disposition (PD) programs; and
Category 3: The Section 8 Project-Based Certificate (PBC) program.
Each Section 8 program category uses the AAFs differently. The specific application of the AAFs is determined by the law, the HAP contract, and appropriate program regulations or requirements.
AAFs are not used in the following cases:
This section of the notice provides a broad description of procedures for adjusting the contract rent. Technical details and requirements are described in HUD notices H 2002-10 (Section 8 New Construction and Substantial Rehabilitation, Loan Management, and Property Disposition) and PIH 97-57 (Moderate Rehabilitation and Project-Based Certificates).
Because of statutory and structural distinctions among the various Section 8 programs, there are separate rent adjustment procedures for the three program categories:
In the Section 8 New Construction and Substantial Rehabilitation programs, the published AAF factor is applied to the pre-adjustment contract rent. In the Section 8 Moderate Rehabilitation program (both the regular program and the single room occupancy program), the published AAF is applied to the pre-adjustment base rent.
For Category 1 programs, the Table 1 AAF factor is applied before determining comparability (rent reasonableness). Comparability applies if the pre-adjustment gross rent (pre-adjustment contract rent plus any allowance for tenant-paid utilities) is above the published Fair Market Rent (FMR).
If the comparable rent level (plus any initial difference) is lower than the contract rent as adjusted by application of the Table 1 AAF, the comparable rent level (plus any initial difference) will be the new contract rent. However, the pre-adjustment contract rent will not be decreased by application of comparability.
In all other cases (i.e., unless the contract rent is reduced by comparability):
• The Table 1 AAF is used for a unit occupied by a new family since the last annual contract anniversary.
• The Table 2 AAF is used for a unit occupied by the same family as at the time of the last annual contract anniversary.
At this time Category 2 programs are not subject to comparability. (Comparability will again apply if HUD establishes regulations for conducting comparability studies under 42 U.S.C. 1437f(c)(2)(C).)
The applicable AAF is determined as follows:
• The Table 1 AAF is used for a unit occupied by a new family since the last annual contract anniversary.
• The Table 2 AAF is used for a unit occupied by the same family as at the time of the last annual contract anniversary.
The following procedures are used to adjust contract rent for outstanding HAP contracts in the Section 8 PBC program:
• The Table 2 AAF is always used. The Table 1 AAF is not used.
• The Table 2 AAF is always applied before determining comparability (rent reasonableness).
• Comparability always applies. If the comparable rent level is lower than the rent to owner (contract rent) as adjusted by application of the Table 2 AAF, the comparable rent level will be the new rent to owner.
• The new rent to owner will not be reduced below the contract rent on the effective date of the HAP contract.
In accordance with Section 8(c)(2)(A) of the United States Housing Act of 1937 (42 U.S.C. 1437f(c)(2)(A)), the AAF is reduced by 0.01:
• For all tenancies assisted in the Section 8 Project-Based Certificate program.
• In other Section 8 programs, for a unit occupied by the same family at the time of the last annual rent adjustment (and where the rent is not reduced by application of comparability (rent reasonableness)).
The law provides that:
Except for assistance under the certificate program, for any unit occupied by the same family at the time of the last annual rental adjustment, where the assistance contract provides for the adjustment of the maximum monthly rent by applying an annual adjustment factor and where the rent for a unit is otherwise eligible for an adjustment based on the full amount of the factor, 0.01 shall be subtracted from the amount of the factor, except that the factor shall not be reduced to less than 1.0. In the case of assistance under the certificate program, 0.01 shall be subtracted from the amount of the annual adjustment factor (except that the factor shall not be reduced to less than 1.0), and the adjusted rent shall not exceed the rent for a comparable unassisted unit of similar quality, type and age in the market area. 42 U.S.C. 1437f(c)(2)(A).
Because the cost to owners of turnover-related vacancies, maintenance, and marketing are lower for long-term stable tenants, these tenants are typically charged less than recent movers in the unassisted market. Since HUD pays the full amount of any rent increases for assisted tenants in section 8 projects and under the Certificate program, HUD should expect to benefit from this ‘tenure discount.’ Turnover is lower in assisted properties than in the unassisted market, so the effect of the current inconsistency with market-based rent increases is exacerbated. (140 Cong. Rec. 8659, 8693 (1994)).
To implement the law, HUD publishes two separate AAF Tables, Tables 1 and 2. The difference between
AAF Tables 1 and 2 are posted on the HUD User Web site at
The applicable AAF is selected as follows:
• Determine whether Table 1 or Table 2 is applicable. In Table 1 or Table 2, locate the AAF for the geographic area where the contract unit is located.
• Determine whether the highest cost utility is or is not included in contract rent for the contract unit.
• If highest cost utility is included, select the AAF from the column for “Highest Cost Utility Included.” If highest cost utility is not included, select the AAF from the column for “Highest Cost Utility Excluded.”
AAFs are rent inflation factors. Two types of rent inflation factors are calculated for AAFs: Gross rent factors and shelter rent factors. The gross rent factor accounts for inflation in the cost of both the rent of the residence and the utilities used by the unit; the shelter rent factor accounts for the inflation in the rent of the residence, but does not reflect any change in the cost of utilities. The gross rent inflation factor is designated as “Highest Cost Utility Included” and the shelter rent inflation factor is designated as “Highest Cost Utility Excluded.”
AAFs are calculated using CPI data on “rent of primary residence” and “fuels and utilities.”
The rent and fuel and utilities inflation factors for large metropolitan areas and Census regions are based on changes in the rent of primary residence and fuels and utilities CPI indices from 2011 to 2012. The CEX data used to decompose the contract rent inflation factor into gross rent and shelter rent inflation factors come from a special tabulation of 2011 CEX survey data produced for HUD for the purpose of computing AAFs. The utility-to-rent ratio used to produce AAFs comes from 2011 ACS median rent and utility costs.
AAFs are produced for all Class A CPI cities (CPI cities with a population of 1.5 million or more), the four Census Regions, and Puerto Rico. The Class A CPIs are applied to core-based statistical areas (CBSAs), as defined by the Office of Management and Budget (OMB), according to how much of the CBSA is covered by the CPI city-survey. If more than 75 percent of the CBSA is covered by the CPI city-survey, the AAF that is based on that CPI survey is applied to the whole CBSA and to any HUD-defined metropolitan area, called the “HUD Metro FMR Area” (HMFA), within that CBSA. If the CBSA is not covered by a CPI city-survey, the CBSA uses the relevant regional CPI factor. The Puerto Rico CPI covers the entire island rather than a defined city area. An ACS-adjusted CPI is developed for all the CBSAs in Puerto Rico. Almost all U.S. non-metropolitan counties use regional CPI factors.
Each metropolitan area that uses a local CPI update factor is listed alphabetically in the tables and each HMFA is listed alphabetically within its respective CBSA. Each AAF applies to a specific geographic area and to units of all bedroom sizes. AAFs are provided:
• For separate metropolitan areas, including HMFAs and counties that are currently designated as non-metropolitan, but are part of the metropolitan area defined in the local CPI survey.
• For the four Census Regions (to be used for those metropolitan and non-metropolitan areas that are not covered by a CPI city-survey).
AAFs use the same OMB metropolitan area definitions, as revised by HUD, that are used for the FY 2014 FMRs.
To make certain that they are using the correct AAFs, users should refer to the Area Definitions Table section at
Puerto Rico uses its own AAFs calculated from the Puerto Rico CPI as adjusted by the PRCS and the Virgin Islands uses the South Region AAFs. All
Fish and Wildlife Service, Interior.
Notice of initiation of reviews; request for information.
We, the U.S. Fish and Wildlife Service (Service), are initiating 5-year status reviews for five species in Oregon, Palau, Guam, and the Northern Mariana Islands, under the Endangered Species Act of 1973, as amended (Act). A 5-year status review is based on the best scientific and commercial data available at the time of the review; therefore, we are requesting submission of any new information on these species that has become available since the last review.
To ensure consideration in our reviews, we are requesting submission of new information no later than April 21, 2014. However, we will continue to accept new information about any listed species at any time.
For the four species in Palau, Guam, and the Northern Mariana Islands (see table below), submit information to: Deputy Field Supervisor-Programmatic, Attention: 5-Year Review, U.S. Fish and Wildlife Service, Pacific Islands Fish and Wildlife Office, 300 Ala Moana Blvd., Room 3-122, Box 50088, Honolulu, HI 96850.
For the Foskett speckled dace (Oregon), submit information to: Field Supervisor, Attention: 5-Year Review, U.S. Fish and Wildlife Service, Oregon Fish and Wildlife Office, 2600 SE 98th Avenue, Suite 100, Portland, OR 97266. Information on the Oregon species can also be submitted by email to:
Kristi Young, U.S. Fish and Wildlife Service, Pacific Islands Fish and Wildlife Office (see
Under the Act (16 U.S.C. 1531 et seq.), we maintain Lists of Endangered and Threatened Wildlife and Plants (which we collectively refer to as the List) in the Code of Federal Regulations (CFR) at 50 CFR 17.11 (for animals) and 17.12 (for plants). Section 4(c)(2)(A) of the Act requires us to review each listed species' status at least once every 5 years. Our regulations at 50 CFR 424.21 require that we publish a notice in the
A 5-year review considers all new information available at the time of the review. In conducting these reviews, we consider the best scientific and commercial data that has become available since the listing determination or most recent status review, such as:
(A) Species biology, including but not limited to population trends, distribution, abundance, demographics, and genetics;
(B) Habitat conditions, including but not limited to amount, distribution, and suitability;
(C) Conservation measures that have been implemented that benefit the species;
(D) Threat status and trends in relation to the five listing factors (as defined in section 4(a)(1) of the Act); and
(E) Other new information, data, or corrections, including but not limited to, taxonomic or nomenclatural changes, identification of erroneous information contained in the List, and improved analytical methods.
Any new information will be considered during the 5-year review and will also be useful in evaluating the ongoing recovery programs for these species.
This notice announces our active review of the five species listed in the table below.
To ensure that a 5-year review is complete and based on the best available scientific and commercial information, we request new information from all sources. See “What Information Do We Consider in Our Review?” for specific criteria. If you submit information, please support it with documentation such as maps, bibliographic references, methods used to gather and analyze the data, and/or copies of any pertinent publications, reports, or letters by knowledgeable sources.
If you wish to provide information for any species listed above, please submit your comments and materials to the appropriate contact in either the Oregon Fish and Wildlife Office or the Pacific Islands Fish and Wildlife Office (see
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
Comments and materials received will be available for public inspection, by appointment, during normal business hours at the offices where the comments are submitted.
A list of all completed and currently active 5-year reviews addressing species for which the Pacific Region of the Service has lead responsibility is available at
This document is published under the authority of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq.).
Fish and Wildlife Service, Interior.
Notice of intent to prepare an environmental impact statement; request for comments.
The U.S. Fish and Wildlife Service (USFWS) and the National Oceanic and Atmospheric Administration (NOAA) are providing this notice of intent to prepare an Environmental Impact Statement for Kalamazoo River restoration pursuant to National Environmental Policy Act (NEPA) regulations. USFWS, NOAA, and the State of Michigan (collectively referred to as the “Trustees”) are also providing notice of their efforts to plan restoration projects authorized by the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) to compensate for injuries to natural resources from polychlorinated biphenyls (PCBs) released at and from the Allied Paper, Inc./Portage Creek/Kalamazoo River Superfund Site (Superfund Site). The Trustees will prepare a programmatic environmental impact statement (PEIS) to identify and evaluate the environmental impacts associated with restoration actions that may be implemented to compensate for injuries to natural resources and associated services. The public is invited to provide comments to assist the Trustees in the development of a restoration plan (RP). This notice explains the scoping process the Trustees will use to gather input from the public.
Written comments must be received by March 20, 2014.
Written comments for the Trustees to consider should be sent to Lisa Williams, U.S. Fish and Wildlife Service, East Lansing Field Office, 2651 Coolidge Road East Lansing, MI 48823. Comments may also be submitted electronically to
Lisa Williams, USFWS, by email at
Under the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), 42 U.S.C. 9601 et seq., parties responsible for releasing hazardous substances into the environment are liable both for the costs of responding to the release (by cleaning up, containing, or otherwise remediating the release) and for damages arising from injuries to publicly owned or managed natural resources resulting from the release. CERCLA's Natural Resource Damage Assessment (NRDA) regulations (43 CFR11) prescribe the process of assessing the nature and extent of the resulting injury, destruction, or loss of natural resources and the services they provide. Carrying out of the NRDA process also includes determining the compensation required to make the public whole for such injuries, destruction, or loss. CERCLA authorizes certain Federal and State agencies and Indian tribes to act on behalf of the public as Trustees for affected natural resources. Under CERCLA, these agencies and tribes are authorized to assess natural resource injuries and to seek compensation, referred to as damages, from responsible parties, including the costs of performing the damage assessment. The Trustees are required to use recovered damages for the following purposes only: to restore, replace, or acquire the equivalent of the injured or lost resources and services.
The U.S. Fish and Wildlife Service (USFWS) and the National Oceanic and Atmospheric Administration (NOAA) are providing this notice of intent to prepare an Environmental Impact Statement for Kalamazoo River restoration pursuant to National Environmental Policy Act (NEPA) regulations. The NEPA process consists of a set of fundamental objectives that include interagency coordination and cooperation, and public participation in the planning and development of projects. NEPA requires Federal agencies to conduct environmental reviews of proposed actions to consider the potential impacts on the environment. NOAA, USFWS, and the State of Michigan (collectively referred to as the “Trustees”) are also providing notice of their efforts to plan restoration projects to compensate for injuries to natural resources from polychlorinated biphenyls (PCBs) released at and from the Allied Paper, Inc./Portage Creek/Kalamazoo River Superfund Site (Superfund Site). The Trustees seek
The Trustees have engaged the public directly in several ways since initiating the Kalamazoo River Natural Resource Damage Assessment (NRDA) with the release of a Preassessment Screen and a Stage I Assessment Plan in 2000, and have also gathered scoping information from other planning processes in which the public has been engaged. Based on these previous interactions, the Trustees do not plan to hold additional scoping meetings during development of the draft RP/PEIS. As part of the Stage I NRDA process, the Trustees met with the public, solicited restoration project ideas, spoke directly with individuals and organizations like the Kalamazoo River Protection Association and the Kalamazoo River Watershed Council, provided findings at a public meeting, and made the report available for public review and comment (MDEQ et al. 2005;
The Trustees solicited public comment on the Draft OU1 RP/EA during the spring of 2012 and met with the public on May 1, 2012. In doing so, the Trustees received updated input from individuals, the Kalamazoo River Watershed Council, Calhoun Conservation District, Kalamazoo Nature Center, and the Kalamazoo River Cleanup Coalition. These interactions have informed the scope of restoration planning and have helped identify significant issues to be evaluated in the RP/PEIS.
Industrial activities in the Kalamazoo area have released PCBs into the environment. Recycling of carbonless copy paper at several area paper mills was the primary source of PCB release. Waste from the recycling of such paper conducted at Kalamazoo-area paper mills also contained PCBs, and the waste was disposed of by several methods that resulted in releases of PCBs into the environment. These PCBs have contaminated sediments, the water column, and biota in and adjacent to downstream sections of Portage Creek, the Kalamazoo River, and Lake Michigan.
Based on the risks that PCBs pose to the environment and to human health, the U.S. Environmental Protection Agency (EPA) listed the Allied Paper, Inc./Portage Creek/Kalamazoo River Superfund Site on the National Priorities List on August 30, 1990. PCBs are listed as hazardous substances under CERCLA. EPA and the Michigan Department of Environmental Quality currently describe the Site being addressed by the Superfund remedial investigation as including: (1) five disposal areas and six paper mill properties; (2) a 3-mile stretch of Portage Creek from Cork Street in the City of Kalamazoo to where the creek meets the Kalamazoo River; and (3) an approximately 80-mile stretch of the Kalamazoo River, from Morrow Dam to Lake Michigan, with adjacent floodplains, wetlands, and in-stream sediments.
As defined in the Stage 1 Assessment Report (MDEQ et al. 2005; available at
As restoration planning proceeds, the Trustees expect to have opportunities to settle natural resource damage claims with willing parties. The RP/PEIS will provide an ecological framework, with public input, to maximize the benefits of specific restoration projects to the affected resources in the KRE that might be included in or funded by settlements. The RP/PEIS will provide criteria and guidance for Trustees to use in selecting feasible restoration projects. In developing the document, the Trustees will also incorporate public input in the development and evaluation of restoration alternatives, including general categories of potential restoration actions as well as a few specific potential projects.
NEPA, 42 U.S.C. 4321 et seq., and the Council on Environmental Quality regulations implementing NEPA under 40 CFR 1500 et seq., apply to restoration actions by Federal trustees. The purpose of the scoping process is to identify the concerns of the affected public, Federal agencies, States, and Indian tribes; involve the public early in the decision making process; facilitate an efficient EA/EIS preparation process; define the issues and alternatives that will be examined in detail; and save time by ensuring that draft documents adequately address relevant issues. The scoping process reduces paperwork and delay by ensuring that important issues are addressed early.
In compliance with 40 CFR 1505 et seq., the Trustees will include in the NRDA Administrative Record (Record) documents that the Trustees rely upon during the development of the RP and PEIS. The hard copy Record is on file at MDEQ (contact Judith Alfano at (517) 373-7402 or
Please send comments in reference to: (a) developing the draft RP/PEIS; (b) suggestions for additional restoration actions beyond those described in the 2005 Stage I Assessment Report and the Portage Creek/OU1 RP/EA; and (c) considerations for potential impacts of
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
Bureau of Land Management, Interior.
Notice of Intent.
Pursuant to applicable provisions of the Federal Lands Recreation Enhancement Act (REA), the Moab Field Office of the Bureau of Land Management (BLM) is proposing to begin collecting fees for overnight camping within six developed campgrounds.
Effective 6 months after the publication of this notice, the BLM-Utah Moab Field Office would initiate fee collection at the camping areas unless BLM publishes a
J. Rockford Smith, Recreation Division Chief, Moab Field Office, Bureau of Land Management, 82 East Dogwood, Moab, UT 84532, (435) 259-2100. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 to leave a message or question for the above individual. The FIRS is available 24 hours a day, seven days a week. Replies are provided during normal business hours.
The Utah Resource Advisory Council (RAC), functioning as a Recreation Resource Advisory Committee (RRAC), will review the proposal to charge fees at the sites mentioned below. Future adjustments in the fee amount will be made in accordance with the Moab Field Office's Business Plan for BLM Moab Campgrounds (Amended 2014) covering the sites. Future fee adjustments will only be made after consideration of comments received on a publicly reviewed business plan amendment and after consultation with the Utah Recreation Resource Advisory Committee and other appropriate advance public notice.
The BLM is proposing to begin collecting fees for overnight camping within the following six developed campgrounds:
These proposed fee sites are located in Grand County, Utah. Under Section 6802(g)(2) of the REA, the campgrounds listed above qualify as a site wherein visitors can be charged an “Expanded Amenity Recreation Fee.”
Visitors wishing to use the expanded amenities the BLM has developed at Westwater, Bitter Creek, Fish Ford, Cowskin, Hideout and Swasey's Rapid campgrounds would purchase a Recreation Use Permit as described at 43 CFR Part 2930. Specific visitor fees will be identified and posted at the developed campgrounds. Fees must be paid at the self-service pay station located at the developed campgrounds upon occupying the site. Dependent upon need, reservable group camp sites may be developed, and at that time advanced reservation may be made through the reservations office of the Moab Field Office. People holding the America The Beautiful—The National Parks and Federal Recreational Lands—Interagency Senior Pass, or an Interagency Access Pass would be entitled to a 50 percent discount on all expanded amenity fees except those associated with group reservations. Fees charged for use of the group sites would include a non-refundable site reservation fee and a per person use fee.
The Westwater and Fish Ford developed campgrounds were constructed in the middle 1980s and have been in use for more than two decades. Over time, the use has increased and the BLM has added amenities for resource protection and visitor enjoyment. Westwater and Fish Ford are located within the Two Rivers Special Recreation Management Area (SRMA). Westwater campground offers a public water system, four toilets, two changing rooms, seven individual sites (with 15 more under construction), an access road, regular patrols, fire rings, tent spaces, and picnic tables. Fish Ford campground offers one toilet, ten individual sites, an access road, regular patrols, fire rings, tent spaces, and picnic tables.
Bitter Creek campground is located along the Kokopelli's Trail within the Utah Rims SRMA and offers one toilet, 10 individual sites, an access road, regular patrols, fire rings, tent spaces, and picnic tables.
Cowskin campground is located within the Colorado Riverway SRMA and offers one toilet, 10 individual sites, an access road, regular patrols, fire rings, tent spaces, and picnic tables.
Hideout campground is located along the Kokopelli's Trail within the Extensive Recreation Management Area. It offers five individual sites, an access road, regular patrols, fire rings, tent spaces, and picnic tables.
Swasey's Rapid campground is located along the Green River just upstream of the boat ramp and parking area. It is located within the Lower Gray Canyon SRMA. It offers one toilet, 15 individual sites, an access road, regular patrols, fire rings, tent spaces, and picnic tables.
The BLM is committed to provide, and receive fair value for, the use of developed recreation facilities and services in a manner that meets public use demands, provides quality experiences and protects important resources. The BLM's policy is to collect fees at all specialized recreation sites, or where the BLM provides facilities, equipment or services at Federal expense, in connection with outdoor use as authorized by the REA. In an effort to meet increasing demands for services and maintenance of developed facilities, the BLM would implement a fee program for the campgrounds. The BLM's mission for the campgrounds is to ensure that funding is available to maintain facilities and recreational
Development, improvement, and fee collection at these six sites are consistent with the 2008 Moab Resource Management Plan and were analyzed in the Environmental Impact Statement accompanying the plan (EIS UT-060-2007-04). Camping and group use fees would be consistent with other established fee sites in the area including other BLM-administered sites in the area and those managed by the United States Forest Service, United States National Park Service, and Utah State Parks and Recreation. Future adjustments in the fee amount will be made following the Moab Field Office's recreation fee business plan covering the sites, in consultation with the Utah RRAC and other public notice prior to a fee adjustment.
In December 2004, the REA was signed into law. The REA provides authority, for 10 years, for the Secretaries of the Interior and Agriculture to establish, modify, charge, and collect recreation fees for use of some Federal recreation lands and waters, and contains specific provisions addressing public involvement in the establishment of recreation fees, including a requirement that RRACs or Councils have the opportunity to make recommendations regarding establishment of such fees. REA also directed the Secretaries of the Interior and Agriculture to publish advance notice in the
16 U.S.C. 6803(b).
Bureau of Land Management, Interior.
Final supplementary rules.
The Bureau of Land Management (BLM) Winnemucca District, Humboldt River Field Office is establishing supplementary rules relating to camping, the discharge of firearms, and the use of motor vehicles on public land within Zone 1 of the Water Canyon Recreation Area. The supplementary rules are necessary to protect natural resources and the health and safety of public land users within the Zone 1 area. These supplementary rules allow BLM law enforcement personnel to limit the number of successive days of camping and to regulate vehicle use in the Zone 1 area. These supplementary rules allow BLM law enforcement personnel to support state and local law enforcement agencies with enforcement of law in prohibiting the discharge of firearms and in restricting motor vehicles to the posted speed limit.
These rules are effective April 21, 2014.
You may direct inquiries to Joey Carmosino, Outdoor Recreation Planner, BLM, Humboldt River Field Office, 5100 E. Winnemucca Blvd., Winnemucca, NV 89445.
Joey Carmosino, Winnemucca District Humboldt River Field Office, (775) 623-1771, email:
These supplementary rules affect public lands identified as Zone 1 of the Water Canyon Recreational Area. Water Canyon is 4 miles southeast of Winnemucca, Nevada. Zone 1 is the portion of the Canyon that receives the most recreational use. Traffic and trail counters confirm annual visitation to the area is in the range of 50,000 people and 25,000 vehicles. Zone 1 is a fenced corridor of public land within Township 35 North, Range 38 East, Mount Diablo Meridian, through portions of sections 2, 11, and 12, in Humboldt County, Nevada. The Zone 1 fenced corridor is of variable width perpendicular to the centerline of Water Canyon Road with an overall width average of approximately 600 feet and running approximately 1.8 miles in length along Water Canyon Road.
The width of the Zone 1 fenced corridor (600 feet wide) is an average of the hereinafter described centerline of Water Canyon Road, its legal land description is as follows:
Beginning at approximately Latitude 40°55′53.7811″ North and Longitude 117°40′39.6508″ West at intersection of Water Canyon Road and the Zone 1 fence; thence, systematically traversing southeasterly along said centerline of Water Canyon Road to approximately Latitude 40°55′13.6513″ North and Longitude 117°38′58.9198″ West at intersection of Water Canyon Road and the Zone 1 fence and being the Point of Termination.
The area described contains 131 acres, more or less, calculated based on Zone 1 being 600 feet wide and 1.8 miles long in Humboldt County.
The referenced latitudes and longitudes in this description are 1983 National Geodetic Reference System values as digitized from United States Geologic Survey 1:24,000 7.5 minute quadrangle map Winnemucca East, Nev., Provisional Edition 1983.
The final supplementary rules are necessary to help the BLM achieve management objectives and to implement the decisions of the Water Canyon Recreation Area Management Plan and Environmental Assessment, Decision Record, and Cooperative Management Agreement approved August 15, 1997, and the Water Canyon Implementation Plan Amendment Environmental Assessment of August
The Water Canyon Cooperative Management Plan is a collaborative effort and was undertaken among the BLM, the Nevada Department of Wildlife, Humboldt County, the City of Winnemucca, and the public to elicit concerns, define issues, and develop a set of desired future conditions for the planning area. The outcome of this process was the development of a set of objectives intended to guide subsequent management actions within Water Canyon. These objectives include: Protecting surface and subsurface water quality within the watershed; providing recreational opportunities; preserving broad-leafed trees, high quality riparian areas, and grassy meadows; and providing for a diversity of wildlife habitats.
To achieve these objectives, a series of alternative proposals were evaluated which prescribed different allowable uses of the planning area and defined other management actions to reach these desired outcomes. The evaluation process led to a series of management decisions that emphasized a combination of moderate and low development actions organized around the division of the planning area into lowland (Zone 1) and upland (Zone 2) areas.
The BLM published proposed supplementary rules in the
In the preparation of the two EAs, the BLM sought public review of three alternatives in the Management Plan and two alternatives in the Implementation Plan. These EAs discuss specific management actions that restrict certain activities and define allowable uses. The final supplementary rules implement these management actions within Zone 1 of the Water Canyon Recreation Area.
20 Miles-per-hour (mph) Speed Limit: Zone 1 is a high traffic area that includes walkers, hikers and vehicles. A speed restriction is needed to protect users from accidents. The road passes by each campsite, and while maintained, it is a gravel road which makes emergency or panic stops difficult. A 20 mph speed limit allows for timely driving through Zone 1 while supporting public safety for all users.
Motor vehicle restriction: All motor vehicles are restricted to travel only on the main access/canyon road in Zone 1. This restriction is proposed to further protect the wetland and riparian areas that are in close proximity to the main access/canyon road in Zone 1.
The final rules clarify that “motor vehicles” include motorcycles, all-terrain vehicles, and off-highway vehicles. This is a logical extension of the proposed rules to provide the public notice which vehicles are affected by these rules.
No Discharging of Firearms: Zone 1 is 1.8 miles long and narrow. The number of visitors that are in close proximity make the safe discharge of firearms impractical. The discharge of firearms is only prohibited in Zone 1 and continues to be allowed in the surrounding area. The final rules include a common definition of “firearms.” This is a logical extension of the proposed rules to clarify for visitors what is prohibited.
Three Day Camping Limitation: Limiting camping to no more than three consecutive nights in a 30-day period is needed because there are a small number of campsites available in Zone 1. By limiting the number of days a camper may use a campsite, there will be more opportunities for visitors to obtain a campsite. By limiting camping to three consecutive nights, the BLM will be able to dissuade long-term habitation or squatting in the Zone 1 campsites. There have been several instances of long-term camping in this area in the past. This rule will allow law enforcement officers to address this issue.
These supplementary rules do not constitute a significant regulatory action and are not subject to review by the Office of Management and Budget under Executive Order 12866. These supplementary rules will not have an annual effect of $100 million or more on the economy. They will not adversely affect in a material way the economy, productivity, competition, jobs, the environment, public health, or safety, or state, local, or tribal governments or communities. These supplementary rules will not create a serious inconsistency or otherwise interfere with an action taken or planned by another agency. These supplementary rules do not materially alter the budgetary effects of entitlements, grants, user fees, or loan programs or the rights or obligations of their recipients; nor do they raise novel legal or policy issues. These supplementary rules are merely rules of conduct for public use of a limited area of public lands.
During the National Environmental Policy Act process, many alternatives were analyzed, including these final supplementary rules. The pertinent analysis and rationale can be found in Management Plan, inclusive of the EA, Decision Record and Cooperative Management Agreement approved August 15, 1997, and the Implementation Plan EA signed August 2005. These final supplementary rules provide for enforcement of decisions made in the Management Plan and Implementation Plan. The EAs mentioned above are available for review in the BLM administrative record at the address specified in the
Congress enacted the Regulatory Flexibility Act (RFA) of 1980, as amended (5 U.S.C. 601-612) to ensure that government regulations do not unnecessarily or disproportionately burden small entities. The RFA requires a regulatory flexibility analysis if a rule will have a significant economic impact, either detrimental or beneficial, on a substantial number of small entities. These supplementary rules merely establish rules of conduct for public use of a limited area of public lands. Therefore, the BLM has determined under the RFA that these supplementary rules would not have a significant economic impact on a substantial number of small entities.
These supplementary rules are not considered a major rule as defined under 5 U.S.C. 804(2). These supplementary rules merely establish rules of conduct for public use of a limited area of public lands and do not affect commercial or business activities of any kind.
These supplementary rules do not impose an unfunded mandate on state, local, or tribal governments in the aggregate, or on the private sector of more than $100 million per year; nor do they have a significant or unique effect on small governments. The supplementary rules have no effect on governmental or tribal entities and would impose no requirements on any of these entities. These supplementary
These supplementary rules do not have significant takings implications, nor are they capable of interfering with Constitutionally-protected property rights. These supplementary rules merely establish rules of conduct for public use of a limited area of public lands and do not affect anyone's property rights. Therefore, the BLM has determined that these supplementary rules will not cause a taking of private property or require preparation of a takings assessment under this Executive Order.
These supplementary rules will not have a substantial direct effect on the states, the relationship between the Federal government and the states, or the distribution of power and responsibilities among the various levels of government. These supplementary rules do not come into conflict with any state law or regulation. Therefore, under Executive Order 13132, the BLM has determined that these supplementary rules do not have sufficient Federalism implications to warrant preparation of a Federalism Assessment.
Under Executive Order 12988, these supplementary rules will not unduly burden the judicial system and that they meet the requirements of sections 3(a) and 3(b)(2) of the Order.
In accordance with Executive Order 13175, these supplementary rules do not include policies that have tribal implications. These supplementary rules do not affect land held for the benefit, nor impede the rights of, Indians or Alaska Natives. These supplementary rules have no associated ground disturbance and are directly associated with general public health and safety.
The Information Quality Act (Section 515 of Pub. L. 106-554) requires Federal agencies to maintain adequate quality, objectivity, utility, and integrity of the information they disseminate. In developing these supplementary rules, the BLM did not conduct or use a study, experiment, or survey or disseminate any information to the public.
These supplementary rules do not constitute a significant energy action. These supplementary rules will not have an adverse effect on energy supplies, production, or consumption, and have no connection with energy policy.
These supplementary rules do not provide for any information collection that the Office of Management and Budget must approve under the Paperwork Reduction Act, 44 U.S.C. 3501
The principal author of these supplementary rules is Joey Carmosino, Outdoor Recreation Planner, BLM Winnemucca District.
For the reasons stated in the preamble and under the authorities for supplementary rules found at 43 U.S.C. 1740 and 43 CFR 8365.1-6, the BLM Nevada State Director issues supplementary rules for public lands managed by the BLM in Nevada, to read as follows:
1. These supplementary rules apply, except as specifically exempted, to activities within the Zone 1 of the Water Canyon Recreation Area, which is comprised of public lands administered by the BLM near Winnemucca, Nevada.
2. These supplementary rules are in effect on a year-round basis.
3. Camping in Zone I is limited to no more than 3 consecutive nights in a 30-day period.
4. The discharge of any firearm in Zone I is prohibited.
(a) A firearm means any weapon; for example, a compressed gas or spring powered pistol or rifle, bow and arrow, cross bow, blowgun, spear gun, spear, sling shot, irritant gas device or any implement designed to or may be converted to expel a projectile by the action of an explosive.
5. All motor vehicles, including motorcycles, all-terrain vehicles, and off-highway vehicles, must not exceed the posted speed limit of 20 miles per hour on the main access/canyon road in Zone I.
6. All motor vehicles, including motorcycles, all-terrain vehicles, and off-highway vehicles, are restricted to travel only on the main access/canyon road in Zone I.
Bureau of Land Management, Interior.
Notice of Realty Action.
The Bureau of Land Management (BLM) has examined and found suitable for classification for lease and/or subsequent conveyance under the provisions of the Recreation and Public Purposes (R&PP) Act, as amended, approximately 15 acres of public land in the unincorporated town of Moapa, Clark County, Nevada. Clark County proposes to use the land for a park.
Interested parties may submit written comments regarding the proposed classification of the land for lease and/or subsequent conveyance of the land, and the environmental assessment, until April 4, 2014.
Send written comments to the BLM Las Vegas Field Manager, 4701 N. Torrey Pines Drive, Las Vegas, NV 89130, or email:
Dorothy Jean Dickey, 702-515-5119, or
Clark County has filed an application to develop the following described land as a park with related facilities near Henrie Road and Patriots Way in the unincorporated town of Moapa, Clark County, Nevada:
The area described contains 15 acres, more or less, in Clark County.
The park will consist of two soccer fields and a general park area with related facilities. Related facilities include parking lots, landscaping, lighting, walkways, drainage, irrigation, restrooms, concessions, utilities and ancillary improvements. Additional detailed information pertaining to this application, plan of development, and site plan is in case file N-87303, which is located at the BLM, Las Vegas Field Office at the address in the
The land is not required for any Federal purpose. The lease and/or subsequent conveyance is consistent with the BLM Las Vegas Resource Management Plan dated October 5, 1998, and would be in the public interest. Clark County, a qualified applicant under the R&PP Act, has not applied for more than the 6,400-acre limitation consistent with the regulations at 43 CFR 2741.7(a)(1), and has submitted a statement in compliance with the regulations at 43 CFR 2741.4(b).
The lease and/or subsequent conveyance of the public land would be subject to valid existing rights. Subject to limitations prescribed by law and regulations, prior to patent issuance, a holder of any right-of-way within the lease area may be given the opportunity to amend the right-of-way for conversion to a new term, including perpetuity, if applicable.
The lease and/or subsequent conveyance, if issued, would be subject to the provisions of the R&PP Act and applicable regulations of the Secretary of the Interior, and would contain the following terms, conditions, and reservations to the United States:
1. A right-of-way thereon for ditches or canals constructed by the authority of the United States, Act of August 30, 1890 (43 U.S.C. 945);
2. All minerals shall be reserved to the United States, together with the right to prospect for, mine, and remove such deposits from the same under applicable law and such regulations as the Secretary of the Interior may prescribe;
3. Valid existing rights;
4. Right-of-way N-06038 for a kV power distribution line, granted to Overton Power District, its successors or assigns, pursuant to the Act of October 21, 1976, (43 U.S.C. 1761);
5. Right-of-way N-11028 for an underground water pipeline, granted to Moapa Valley Water District, its successors or assigns, pursuant to the Act of October 21, 1976, (43 U.S.C. 1761);
6. Right-of-way N-52748 for a rain gage and road access, granted to Clark County Regional Flood Control, its successors or assigns, pursuant to the Act of October 21, 1976, (43 U.S.C. 1761);
7. Right-of-way N-92187 for drainage, fence, and wall improvements, granted to the Clark County School District, its successors or assigns, pursuant to the Act of October 21, 1976, (43 U.S.C. 1761);
8. An appropriate indemnification clause protecting the United States from claims arising out of the lessee's/patentee's use, occupancy, or occupations on the leased/patented lands.
Upon publication of this notice in the
Interested parties may submit written comments on the suitability of the land for a park. Comments on the classification are restricted to whether the land is physically suited for the proposal, whether the use will maximize the future use or uses of the land, whether the use is consistent with local planning and zoning, or if the use is consistent with State and Federal programs.
Interested parties may also submit written comments regarding the specific use proposed in the application and plan of development, and whether the BLM followed proper administrative procedures in reaching the decision to lease and/or convey under the R&PP Act.
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. Any adverse comments will be reviewed by the BLM Nevada State Director, who may sustain, vacate, or modify this realty action. In the absence of any adverse comments, the decision will become effective on April 21, 2014. The lands will not be available for lease and/or subsequent conveyance until after the decision becomes effective.
43 CFR 2741.5(h).
National Park Service, Interior.
Public Notice.
The National Park Service hereby gives public notice that it proposes to extend the following expiring concession contracts for a period of up to 1 (one) year, or until the effective date of a new contract, whichever occurs sooner.
Effective January 1, 2014.
Ben Erichsen, Chief, Commercial Services Program, National Park Service, 1201 Eye Street NW., 11th Floor, Washington, DC 20005, Telephone (202) 513-7156.
All of the listed concession authorizations will expire by their terms on or before December 31, 2013. Pursuant to 36 CFR 51.23, the National Park Service has determined that the proposed short-term extensions are necessary in order to avoid interruption of visitor services and has taken all reasonable and appropriate steps to consider alternatives to avoid such interruption.
Under the provisions of current concession contracts and pending the completion of the public solicitation of a prospectus for a new concession contract, the National Park Service authorizes extension of visitor services for the contracts below until the dates shown under the terms and conditions of the current contract as amended. The extension of operations does not affect any rights with respect to selection for award of a new concession contract.
National Park Service, Interior.
Notice of amendment to an existing system of records.
Pursuant to the provisions of the Privacy Act of 1974, as amended, the Department of the Interior is issuing a public notice of its intent to amend the National Park Service Privacy Act system of records, “Special Use Permits—Interior, NPS-1,” to update the system location, categories of individuals covered by the system, categories of records in the system, authority, routine uses, storage, safeguards, retention and disposal, system manager and address, notification procedures, records access and contesting procedures, and record source categories. The purpose of the system is to provide a park superintendent with information to approve or deny requests for activities that provide a benefit to an individual, group or organization, rather than the public at large. The system also assists park staff to manage the activity to ensure that the permitted activity does not interfere with the enjoyment of the park by visitors and that the natural and cultural resources of the park are protected.
Comments must be received by March 31, 2014.
Any person interested in commenting on this notice may do so by: submitting comments in writing to Felix Uribe, National Park Service
Special Park Uses Program Manager, 1849 C Street NW., Mail Stop 2460, Washington, DC 20240; or by telephone at 202-513-7092.
The Department of the Interior (DOI), National Park Service (NPS) maintains the “Special Use Permits—Interior, NPS-1” system of records. The purpose of the system is to provide a park superintendent with information to approve or deny requests for activities that provide a benefit to an individual, group or organization, rather than the public at large. The system also assists park staff to manage the activity to ensure that the permitted activity does not interfere with the enjoyment of the park by visitors and that the natural and cultural resources of the park are protected. The system was last published in the
The amendments to the system will be effective as proposed at the end of the comment period (the comment period will end 40 days after the publication of this notice in the
The Privacy Act of 1974, as amended, embodies fair information practice principles in a statutory framework governing the means by which Federal Agencies collect, maintain, use, and disseminate individuals' personal information. The Privacy Act applies to information that is maintained in a “system of records.” A “system of records” is a group of any records under the control of an agency for which information is retrieved by the name of an individual or by some identifying number, symbol, or other identifying particular assigned to the individual. The Privacy Act defines an individual as a United States citizen or lawful permanent resident. As a matter of policy, DOI extends administrative Privacy Act protections to all individuals. Individuals may request access to their own records that are maintained in a system of records in the possession or under the control of DOI by complying with DOI Privacy Act regulations, 43 CFR Part 2.
The Privacy Act requires each agency to publish in the
In accordance with 5 U.S.C. 552a(r), DOI has provided a report of this system of records to the Office of Management and Budget and to Congress.
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment, including your personal identifying information, may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
Special Use Permits—Interior, NPS-1
Records in this system are maintained by the Special Park Uses Program, 1849 C Street NW., Mail Stop 2460, Washington, DC 20240. Records may also be located at the parks responsible for issuing special use permits.
Individuals covered by the system include NPS employees and contractors responsible for processing applications for special use permits, applicants of special use permits, and holders of special use permits. This system contains records concerning corporations and other business entities, which are not subject to the Privacy Act. However, records pertaining to individuals acting on behalf of corporations and other business entities may reflect personal information.
The system contains: (1) Applications for special use permits and may include name, organization, social security number, tax identification number, address, telephone number, fax number, email address, person's position title; information of proposed activity including park alpha code, permit number, date, location, number of participants and vehicles, type of use, equipment, support personnel for the activity, company, project name and type, fees, liability insurance information; information on special activities including number of minors, livestock, aircraft type, special effects, special effect technician's license and permit number, stunts, unusual or hazardous activities; information on driver's license including number, state, and expiration date; vehicle information including year, make, color, weight, plate number, and insurance; and (2) supporting documentation for permitted activities containing site plans, diagrams, story boards or scripts, crowd control and emergency medical plans and proposed site plan(s).
16 U.S.C. 1, National Park Service Organic Act; 16 U.S.C. 3, Rules and regulations of national parks, reservations, and monuments; timber; leases, 16 U.S.C. 3a, Recovery of costs associated with special use permits; and 16 U.S.C. 460
The purposes of the system are (1) to provide a park superintendent with information to approve or deny requests for activities that provide a benefit to an individual, group or organization, rather than the public at large; and (2) to assist park staff to manage the activity to ensure that the permitted activity does not interfere with the enjoyment of the park by visitors and that the natural and cultural resources of the park are protected.
In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act, disclosures outside DOI may be made as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:
(1)(a) To any of the following entities or individuals, when the circumstances set forth in paragraph (b) are met:
(i) The U.S. Department of Justice (DOJ);
(ii) A court or an adjudicative or other administrative body;
(iii) A party in litigation before a court or an adjudicative or other administrative body; or
(iv) Any DOI employee acting in his or her individual capacity if DOI or DOJ has agreed to represent that employee or pay for private representation of the employee;
(b) When:
(i) One of the following is a party to the proceeding or has an interest in the proceeding:
(A) DOI or any component of DOI;
(B) Any other Federal agency appearing before the Office of Hearings and Appeals;
(C) Any DOI employee acting in his or her official capacity;
(D) Any DOI employee acting in his or her individual capacity if DOI or DOJ has agreed to represent that employee or pay for private representation of the employee;
(E) The United States, when DOJ determines that DOI is likely to be affected by the proceeding; and
(ii) DOI deems the disclosure to be:
(A) Relevant and necessary to the proceeding; and
(B) Compatible with the purpose for which the records were compiled.
(2) To a congressional office in response to a written inquiry that an individual covered by the system, or the heir of such individual if the covered individual is deceased, has made to the office.
(3) To any criminal, civil, or regulatory law enforcement authority (whether Federal, state, territorial, local, tribal or foreign) when a record, either alone or in conjunction with other information, indicates a violation or potential violation of law—criminal, civil, or regulatory in nature, and the disclosure is compatible with the purpose for which the records were compiled.
(4) To an official of another Federal agency to provide information needed in the performance of official duties related to reconciling or reconstructing data files or to enable that agency to respond to an inquiry by the individual to whom the record pertains.
(5) To Federal, state, territorial, local, tribal, or foreign agencies that have requested information relevant or necessary to the hiring, firing or retention of an employee or contractor, or the issuance of a security clearance, license, contract, grant or other benefit, when the disclosure is compatible with the purpose for which the records were compiled.
(6) To representatives of the National Archives and Records Administration to conduct records management inspections under the authority of 44 U.S.C. 2904 and 2906.
(7) To state and local governments and tribal organizations to provide information needed in response to court order and/or discovery purposes related to litigation, when the disclosure is compatible with the purpose for which the records were compiled.
(8) To an expert, consultant, or contractor (including employees of the contractor) of DOI that performs services requiring access to these records on DOI's behalf to carry out the purposes of the system.
(9) To appropriate agencies, entities, and persons when:
(a) It is suspected or confirmed that the security or confidentiality of information in the system of records has been compromised; and
(b) The Department has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interest, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the Department or another agency or entity) that rely upon the compromised information; and
(c) The disclosure is made to such agencies, entities and persons who are reasonably necessary to assist in connection with the Department's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
(10) To the Office of Management and Budget during the coordination and clearance process in connection with legislative affairs as mandated by OMB Circular A-19.
(11) To the Department of the Treasury to recover debts owed to the United States.
(12) To the news media when the disclosure is compatible with the purpose for which the records were compiled.
(13) To a consumer reporting agency if the disclosure requirements of the Debt Collection Act, as outlined at 31 U.S.C. § 3711(e)(1), have been met.
Paper records are contained in file folders stored within filing cabinets. Electronic records are maintained in computers, computer databases, email, and electronic media such as removable hard drives, magnetic disks, compact discs, and computer tapes.
Records in the system are retrieved by permittee's name, permit number or date of activity.
The records contained in this system are safeguarded in accordance with 43 CFR 2.226 and other applicable security rules and policies. Paper records are maintained in file cabinets located in secured DOI facilities under the control of authorized personnel.
Access to DOI networks and records in this system requires a valid username and password, and is limited to DOI personnel who have a need to know the information for the performance of their official duties. Computers and storage media are encrypted in accordance with DOI security policy. Computers containing files are password protected to restrict unauthorized access. The computer servers in which electronic records are stored are located in secured Department of the Interior facilities. Personnel authorized to access systems must complete all Security, Privacy, and Records Management training and sign the DOI Rules of Behavior.
Records in this system are retained in accordance with the National Park Service Records Schedule Resource Management and Lands, which has been approved by the National Archives and Records Administration (Job No. N1-79-08-1). The disposition is temporary. Retention of records with short-term operational value and not considered essential for the ongoing management of land and cultural and natural resources are destroyed 15 years after closure.
Paper records are disposed of by shredding or pulping, and records contained on electronic media are degaussed or erased in accordance with 384 Departmental Manual 1.
Special Park Uses Program Manager, 1849 C Street NW., Mail Stop 2460, Washington, DC 20240.
An individual requesting notification of the existence of records on himself or herself should send a signed, written inquiry to the System Manager identified above. The request envelope and letter should both be clearly marked “PRIVACY ACT INQUIRY.” A request for notification must meet the requirements of 43 CFR 2.235.
An individual requesting records on himself or herself should send a signed, written inquiry to the System Manager identified above. The request should describe the records sought as specifically as possible. The request envelope and letter should both be
An individual requesting corrections or the removal of material from his or her records should send a signed, written request to the System Manager identified above. A request for corrections or removal must meet the requirements of 43 CFR 2.246.
Records in the system are obtained from applicants of special use permits and holders of special use permits.
None.
The National Park Service (NPS) maintains the Special Use Permits system of records. The purpose of the system is to provide a park superintendent with information to approve or deny requests for activities that provide a benefit to an individual, group or organization, rather than the public at large. The system also assists park staff to manage the activity to ensure that the permitted activity does not interfere with the enjoyment of the park by visitors and that the natural and cultural resources of the park are protected.
The NPS only collects information that is necessary to execute the responsibilities of the Special Park Uses (SPU) Program. The SPU Program provides information and policy guidance to park superintendents, and regional and park special park uses personnel on permits such as right-of-way permits, special event and First Amendment permits, and commercial film permits.
The NPS estimates that the Special Use Permits system will contain a large amount of individual records for those individuals that have applied for special use permits from the National Park Service, and currently hold special use permits. The system contains records concerning corporations and other business entities, which are not subject to the Privacy Act. However, records pertaining to individuals acting on behalf of corporations and other business entities may reflect personal information. The National Park Service receives in excess of 18,000 applications per year for special park use permits, of which approximately 13,000 applications are received from individuals.
Steps were taken to minimize the amount of personal information maintained in the Special Use Permits system. Only information that is required to provide a superintendent with sufficient information to make an informed decision on the request for a permit is collected. Social security or tax identification numbers are collected in accordance with the Debt Reduction Act.
16 U.S.C. 1, National Park Service Organic Act; 16 U.S.C. 3, Rules and regulations of national parks, reservations, and monuments; timber; leases, 16 U.S.C. 3a, Recovery of costs associated with special use permits; and 16 U.S.C. 460
The Special Use Permits System collects and stores information from individuals, businesses or government entities (including personally identifiable information from individuals representing businesses) that apply or are granted permits for special uses at the National Park Service.
The Special Park Uses Program has taken measures to protect the information in the system and as a result, there is a minimal risk to the privacy of most individuals.
DOI may share information contained within the NPS Special Use Permits system with other Federal, state and local governments to provide information needed to recover debts owed to the United States, to respond to a violation or potential violation of law, in response to court order and/or discovery purposes related to litigation, or other authorized routine use when the disclosure is compatible with the purpose for which the records were compiled.
The records contained in this system are safeguarded in accordance with 43 CFR 2.226 and other applicable security rules and policies. Paper records are maintained in file cabinets located in secured DOI facilities under the control of authorized personnel.
Access to DOI networks and records in this system requires a valid username and password, and is limited to DOI personnel who have a need to know the information for the performance of their official duties. Computers and storage media are encrypted in accordance with DOI security policy. Computers containing files are password protected to restrict unauthorized access. The computer servers in which electronic records are stored are located in secured Department of the Interior facilities. Personnel authorized to access systems must complete all Security, Privacy, and Records Management training and sign the DOI Rules of Behavior.
Each proposed routine use is compatible with the purpose of this system because it either: promotes the integrity of the records in the system or servicing and maintenance of the system; improves access by individuals who are the subjects of the information in the system, pursuant to the Privacy Act of 1974, 5 U.S.C. § 552a; or carries out a statutory responsibility of the Department, or requires that a specific determination be made prior to disclosure that a concrete relationship or similarity exists between the disclosure and the purpose for which the information in the system was gathered.
The Special Use Permits—Interior, NPS—1 is comprised of information taken from NPS forms (OMB Control Number: 1024-0026). The forms are: Application for Special Use Permit, #10-930, expires 06/2013; Application for Commercial Filming/Still Photography Permit (short form), #10-931, expires 06/2013; Application for Commercial Filming/Still Photography Permit (long form), #10-932, expires 06/2013; and two new forms, Application for Vehicle Use Permit, #10-933 and
No. This system of records does not require new or revised agency rules to be published in the
Office of Surface Mining Reclamation and Enforcement, Department of the Interior.
Notice of Proposed Information Collection; Request for comments for 1029-0024.
In compliance with the Paperwork Reduction Act of 1995, the Office of Surface Mining Reclamation and Enforcement (OSM) is announcing that the information collection request for the Procedures and Criteria for Approval or Disapproval of State Program Submissions, has been forwarded to the Office of Management and Budget (OMB) for review and comment. The information collection request describes the nature of the information collection and the expected burden and cost.
OMB has up to 60 days to approve or disapprove the information collection but may respond after 30 days. Therefore, public comments should be submitted to OMB by March 20, 2014, in order to be assured of consideration.
Submit comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Department of the Interior Desk Officer, by telefax at (202) 395-5806 or via email to
To receive a copy of the information collection request contact John Trelease at (202) 208-2783, or electronically to
OMB regulations at 5 CFR part 1320, which implement provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13), require that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities [see 5 CFR 1320.8(d)]. OSM has submitted a request to OMB to renew its approval of the collection of information contained in 30 CFR Part 732 for approving or disapproving state program submissions. OSM is requesting a 3-year term of approval for the information collection activity.
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 OMB control number. The OMB control number for this collection of information is 1029-0024 and is referenced in § 732.10.
As required under 5 CFR 1320.8(d), a
Send comments on the need for the collection of information for the performance of the functions of the agency; the accuracy of the agency's burden estimates; ways to enhance the quality, utility and clarity of the information collection; and ways to minimize the information collection burdens on respondents, such as use of automated means of collections of the information, to the addresses listed under
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
United States International Trade Commission.
Notice.
The Commission hereby gives notice that it will proceed with full reviews pursuant to section 751(c)(5) of the Tariff Act of 1930 (19 U.S.C. 1675(c)(5)) to determine whether revocation of the antidumping duty orders on polyethylene terephthalate film, sheet, and strip from Brazil, China, and the United Arab Emirates would be likely to lead to continuation or recurrence of material injury within a reasonably foreseeable time. A schedule for the reviews will be established and announced at a later date. For further information concerning the conduct of these reviews and rules of general application, consult the Commission's Rules of Practice and Procedure, part 201, subparts A through E (19 CFR part 201), and part 207, subparts A, D, E, and F (19 CFR part 207).
Mary Messer (202-205-3193), Office of
On January 23, 2014, the Commission determined that it should proceed to full reviews in the subject five-year reviews pursuant to section 751(c)(5) of the Act. The Commission found that the domestic interested party group response and the respondent interested party group responses with respect to the orders on subject imports from Brazil and the United Arab Emirates to its notice of institution (78 FR 60311, October 1, 2013) were adequate. The Commission found that the respondent interested party group response with respect to the orders on subject imports from China was inadequate but determined to conduct a full review of the order concerning China to promote administrative efficiency in light of the Commission's determination to conduct full reviews of the orders concerning Brazil and the United Arab Emirates. A record of the Commissioners' votes, the Commission's statement on adequacy, and any individual Commissioner's statements will be available from the Office of the Secretary and at the Commission's Web site.
These reviews are being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.62 of the Commission's rules.
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined to remand the above-captioned investigation to the Chief Administrative Law Judge for assignment to an administrative law judge (“ALJ”) for an initial determination on remand (“RID”) concerning certain infringement, affirmative defense, and public interest issues following remand from the U.S. Court of Appeals for the Federal Circuit (“Federal Circuit”).
Megan M. Valentine, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 708-2301. 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 Inv. No. 337-TA-613 on September 11, 2007, based on a complaint filed by InterDigital Communications Corp. of King of Prussia, Pennsylvania and InterDigital Technology Corp. of Wilmington, Delaware (collectively, “InterDigital”) on August 7, 2007. 72
On February 13, 2009, InterDigital moved for summary determination that a domestic industry exists because its licensing activities in the United States satisfy the domestic industry requirement under 19 U.S.C. 1337(a)(3)(C). On March 10, 2009, the presiding Administrative Law Judge (“ALJ”) issued an initial determination (“ID”) (Order No. 42) granting the motion. On April 9, 2009, the Commission determined not to review the ID. Notice (Apr. 9, 2009).
On August 14, 2009, the ALJ issued his final ID, finding no violation of section 337. In particular, he found that the asserted claims of the patents-in-suit are not infringed and that they are not invalid. The ALJ further found that there is no prosecution laches relating to the '004, '966, and '847 patents and that the '579 patent is not unenforceable.
On October 16, 2009, the Commission determined to review the Final ID in part. 74
InterDigital timely appealed the Commission's final determination of no violation of section 337 as to the '966 and '847 patents to Federal Circuit. Specifically, InterDigital appealed the final ID's unreviewed constructions of the claim limitations “code” and “increased power level” in the '966 and '847 patents. Respondent Nokia, the intervenor on appeal, raised as an alternate ground of affirmance the issue of whether the Commission correctly
On August 1, 2012, the Federal Circuit reversed the Commission's construction of the claim limitations “code” and “increased power level” in the '966 and '847 patents, reversed the Commission's determination of non-infringement as to the asserted claims of those patents, and remanded to the Commission for further proceedings.
On February 4, 2013, the Commission issued an Order directing the parties to submit comments regarding what further proceedings must be conducted to comply with the Federal Circuit's remand. Commission Order (Feb. 4, 2013). On February 14, 2013, InterDigital, Nokia, and the Commission investigative attorney (“IA”) submitted initial comments. On February 19, 2013, Nokia submitted response comments. On February 22, 2013, InterDigital and the IA submitted response comments.
Having examined the record of this investigation, including the ALJ's final ID, the petitions for review, the responses thereto, and the parties' comments on remand, the Commission has decided certain issues and has determined to remand the investigation to the Chief ALJ for assignment to a presiding ALJ to determine certain outstanding issues concerning violation of section 337 set forth below.
With respect to claim construction, the Commission construes the claim limitation “synchronize” in the asserted claims of the '847 patent to mean “establishing a timing reference with the pilot signal transmitted by a base station.”
With respect to validity, the Commission affirms the final ID's finding that the Lucas reference does not anticipate the asserted claims of the '966 and '847 patents because it fails to disclose the claim limitations requiring the subscriber unit to transmit a code selected from a “plurality of different codes,” the limitation requiring the subscriber unit to transmit a “message” in order to indicate that the subscriber units wants to establish communications with a base station, or the limitation in those claims requiring an “access signal” to facilitate communication between the subscriber unit and the base station. The Commission also affirms the final ID's finding that the Lucas reference does not render obvious the asserted claims of the '966 and '847 patent. The Commission further affirms the final ID's finding that the asserted claims of the '966 and '847 patents are not rendered obvious by the IS-95 references combined with the CODIT reference.
With respect to infringement, the Commission finds that the PRACH preamble used in the accused Nokia handsets satisfies the “code”/“signal” limitation of the asserted claims of the '966 and '847 patents under the Federal Circuit's revised claim construction. The Commission also finds that the transmission of the PRACH preambles meets the claim limitation “increased power level” in the asserted claims of the '966 and '847 patents based on the Federal Circuit's revised claim construction. The Commission further finds waived Nokia's argument that the PRACH preamble and PRACH message signals in the accused Nokia handsets are never transmitted. The Commission also finds that the accused handsets do not satisfy the “synchronized to a pilot signal” limitation under the doctrine of equivalents.
With respect to the issue of domestic industry, the Commission acknowledges the Federal Circuit's finding that Nokia has waived any argument regarding the nexus between its licensing investments and the asserted patents. The Commission also declines to reconsider the issue of whether the “economic prong” of the domestic industry requirement has been satisfied under
The Commission remands the following issues to the Chief ALJ for assignment to a presiding ALJ. Specifically, the Commission remands the issue of whether the accused Nokia handsets meet the “generated using a same code” limitation or “the message being transmitted only subsequent to the subscriber unit receiving the indication” limitation in the asserted claims of the '966 patent. The Commission also remands the issue of whether the accused Nokia handsets meet the “generated using a same code” limitation or the “function of a same code” limitation in the asserted claims of the '847 patent. The Commission further remands the issue of whether the 3GPP standard supports a finding that the pilot signal (P-CPICH) satisfies the claim limitation “synchronized to a pilot signal” as recited in the asserted claims of the '847 patent by synchronizing to either the P-SCH or S-SCH signals under the Commission's construction of that claim limitation. The Commission further remands the issue, concerning the claim limitations “the message being transmitted only subsequent to the subscriber unit receiving the indication” and “transmitting, in response to receipt of said acknowledgement, an access signal” in the asserted claims of the '847 patent and as is required by the final ID's construction of the limitation “access signal,” whether the PRACH Message is transmitted during the power ramp up process.
The Commission also remands the investigation for the assigned ALJ to reopen the evidentiary record and take evidence concerning Nokia's currently imported products, including: (1) Whether they contain chips other than those that were previously adjudicated, (2) whether those chips infringe the asserted claims of the patents-in-suit, and (3) whether the chips are licensed. The Commission further remands the investigation in order for the assigned ALJ to: (1) Take evidence concerning the public interest factors as enumerated in sections 337(d) and (f); (2) take briefing on whether the issue of the standard-essential patent nature of the patents-in-suit is contested; (3) take evidence concerning and/or briefing on whether there is patent hold-up or reverse hold-up in this case; and (4) include an analysis of this evidence in his remand ID.
The authority for the Commission's determination is contained in section
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (Order No. 69) issued by the presiding administrative law judge (“ALJ”) on January 23, 2014, extending the time for issuance of the final initial determination. Notice is also hereby given that the Commission has determined not to review an initial determination (Order No. 70) issued by the ALJ on January 29, 2014, terminating the investigation based on a settlement agreement.
Robert Needham, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 708-5468. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000. General information concerning the Commission may also be obtained by accessing its Internet server (
The Commission instituted this investigation on January 8, 2013, based on a complaint filed by Ericsson Inc., of Plano, Texas, and Telefonaktiebolaget LM Ericsson of Sweden. 78 FR 1247 (January 8, 2013). The complaint, as amended, alleged violations of section 337 of the Tariff Act of 1930 as amended (19 U.S.C. 1337), in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain electronic devices, including wireless communication devices, tablet computers, media players, and televisions, and components thereof, by reason of infringement of certain claims of eleven U.S. patents. The notice of investigation named as respondents Samsung Electronics America, Inc., of Ridgefield Park, New Jersey; Samsung Telecommunications America LLC, of Richardson, Texas; and Samsung Electronics Co., Ltd., of the Republic of Korea.
On January 22, 2014, all complainants and respondents (“the private parties”) jointly moved to extend the date for issuance of the final initial determination from January 24, 2014, to January 31, 2014. The motion stated that the private parties had reached a settlement agreement, and that the extension would permit the parties time to file termination papers. The motion further stated the Investigative Attorney (“IA”) did not oppose the motion. On January 23, 2014, the ALJ found that good cause existed for the extension, and granted the motion in an initial determination (“Order No. 69”). No party filed a petition for review of Order No. 69.
On January 27, 2014, the private parties moved to terminate the investigation based on a settlement agreement. The parties stated that there were no other agreements, written or oral, express or implied, between the private parties concerning the subject matter of this investigation. The IA filed a response supporting the motion. On January 29, 2014, the ALJ issued an initial determination (“Order No. 70”) granting the motion and terminating the investigation. The ALJ found that the motion complied with the Commission rules and that the settlement is in the public interest. No party filed a petition for review of Order No. 70.
The Commission has determined not to review Order No. 69 and Order No. 70.
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.
30-Day Notice.
The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection is published to obtain comments from the public and affected agencies. This proposed information collection was previously published in the
The purpose of this notice is to allow for an additional 30 days for public comment until March 20, 2014. This process is conducted in accordance with 5 CFR 1320.10
Written comments concerning this information collection should be sent to the Office of Information and Regulatory Affairs, Office of Management and Budget, Attn: DOJ Desk Officer. The best way to ensure your comments are received is to email them to
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your
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Firearms licensees are required to keep records of acquisition and disposition. These records remain with the licensee as long as they are in business. The ATF F 5300.3A, FFL Out-of-Business Records Request is used by ATF to notify licensees who go out of business. When discontinuance of the business is absolute, such records shall be delivered within thirty days following the business discontinuance to the ATF Out-of-Business Records Center.
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If additional information is required contact: Jerri Murray, Department Clearance Officer, Policy and Planning Staff, Justice Management Division, Department of Justice, Two Constitution Square, 145 Street NE., Room 3W-1407B, Washington, DC 20530.
30-Day Notice.
The Department of Justice (DOJ), Drug Enforcement Administration (DEA) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection is published to obtain comments from the public and affected agencies. This proposed information collection was previously published in the
The purpose of this notice is to allow for an additional 30 days for public comment until March 20, 2014. This process is conducted in accordance with 5 CFR 1320.10.
If you have comments, especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Ruth A. Carter, Chief, Policy Evaluation and Analysis Section, Office of Diversion Control, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152; (202) 598-6812.
Written comments concerning this information collection should be sent to the Office of Information and Regulatory Affairs, Office of Management and Budget, Attn: DOJ Desk Officer. The best way to ensure your comments are received is to email them to
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.
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If additional information is required contact: Jerri Murray, Department Clearance Officer, Policy and Planning Staff, Justice Management Division, Department of Justice, Two Constitution Square, 145 N Street NE., Suite 3W-1407B, Washington, DC 20530.
Notice.
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) [44 U.S.C. 3506(c) (2)(A)]. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. The Bureau of Labor Statistics (BLS) is soliciting comments concerning the proposed extension of the “Consumer Price Index Commodities and Services Survey.” A copy of the proposed information collection request (ICR) can be obtained by contacting the individual listed below in the Addresses section of this notice.
Written comments must be submitted to the office listed in the
Send comments to Nora Kincaid, BLS Clearance Officer, Division of Management Systems, Bureau of Labor Statistics, Room 4080, 2 Massachusetts Avenue NE., Washington, DC 20212. Written comments also may be transmitted by fax to, 202-691-5111. (This is not a toll free number.)
Nora Kincaid, BLS Clearance Officer, 202-691-7628 (this is not a toll free number). (See
Under the direction of the Secretary of Labor, the Bureau of Labor Statistics (BLS) is directed by law to collect, collate, and report full and complete statistics on the conditions of labor and the products and distribution of the products of the same; the Consumer Price Index (CPI) is one of these statistics. The collection of data from a wide spectrum of retail establishments and government agencies is essential for the timely and accurate calculation of the Commodities and Services (C&S) component of the CPI.
The CPI is the only index compiled by the U.S. Government that is designed to measure changes in the purchasing power of the urban consumer's dollar. The CPI is a measure of the average change in prices over time paid by urban consumers for a market basket of goods and services. The CPI is used most widely as a measure of inflation, and serves as an indicator of the effectiveness of government economic policy. It is also used as a deflator of other economic series, that is, to adjust other series for price changes and to translate these series into inflation-free dollars. Examples include retail sales, hourly and weekly earnings, and components of the Gross Domestic Product.
A third major use of the CPI is to adjust income payments. Almost 2 million workers are covered by collective bargaining contracts, which provide for increases in wage rates based on increases in the CPI. At least nine states have laws that link the adjustment in state minimum wage to the changes in the CPI. In addition, as a result of statutory action, the CPI affects the income of millions of Americans. Over 57 million Social Security beneficiaries, and millions of military and Federal Civil Service retirees, have cost-of-living adjustments tied to the CPI. Also, eligibility criteria for millions of food stamps recipients and millions of children who eat lunch at school are affected by changes in the CPI. Under the National School Lunch Act and Child Nutrition Act, national average payments for those lunches and breakfasts are adjusted annually by the Secretary of Agriculture on the basis of the change in the CPI series, “Food away from Home.” Since 1985, the CPI has been used to adjust the Federal income tax structure to prevent inflation-induced tax rate increases.
Office of Management and Budget clearance is being sought for the Consumer Price Index Commodities and Services Survey. The continuation of the collection of prices for the CPI is essential since the CPI is the nation's chief source of information on retail price changes. If the information on C&S prices were not collected, Federal fiscal and monetary policies would be hampered due to the lack of information on price changes in a major sector of the U.S. economy, and estimates of the real value of the Gross National Product could not be made. The consequences to both the Federal and private sectors would be far reaching and would have serious repercussions on Federal government policy and institutions.
The Bureau of Labor Statistics is particularly interested in comments that:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility.
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used.
• Enhance the quality, utility, and clarity of the information to be collected.
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses.
Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget approval of the information collection request; they also will become a matter of public record.
Occupational Safety and Health Administration (OSHA), Labor.
Request for public comments.
OSHA solicits public comments concerning its proposal to extend OMB approval of the information collection requirements specified in its Standard on Powered Platforms for Building Maintenance (29 CFR 1910.66).
Comments must be submitted (postmarked, sent, or received) by April 21, 2014.
Theda Kenney or Todd Owen, Directorate of Standards and Guidance, OSHA, U.S. Department of Labor, Room N-3609, 200 Constitution Avenue NW., Washington, DC 20210; telephone (202) 693-2222.
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent (i.e., employer) burden, conducts a preclearance consultation program to provide the public with an opportunity to comment on proposed and continuing information collection requirements in accord with the Paperwork Reduction Act of 1995 (PRA-95) (44 U.S.C. 3506(c)(2)(A)). This program ensures that information is in the desired format, reporting burden (time and costs) is minimal, collection instruments are clearly understood, and OSHA's estimate of the information collection burden is accurate. The Occupational Safety and Health Act of 1970 (the OSH Act) (29 U.S.C. 651 et seq.) authorizes information collection by employers as necessary or appropriate for enforcement of the OSH Act or for developing information regarding the causes and prevention of occupational injuries, illnesses, and accidents (29 U.S.C. 657). The OSH Act also requires that OSHA obtain such information with minimum burden upon employers, especially those operating small businesses, and to reduce to the maximum extent feasible unnecessary duplication of efforts in obtaining information (29 U.S.C. 657).
Paragraph (e)(9) of the Powered Platform for Building Maintenance Standard requires that employers develop and implement a written emergency action plan for each type of powered platform operation. The plan must explain the emergency procedures that workers are to follow if they encounter a disruption of the power supply, equipment failure, or other emergency. Prior to operating a powered platform, employers must notify workers how they can learn about alarm systems and emergency escape routes, and emergency procedures that pertain to the building at which they will be working. Employers are to review with each worker those parts of the emergency action plan that the worker must know to ensure their protection during an emergency; these reviews must occur when the worker receives an initial assignment involving a powered
According to paragraph (f)(5)(i)(C), employers must affix a load rating plate to a conspicuous location on each suspended unit that states the unit's weight and its rated load capacity. Paragraph (f)(5)(ii)(N) requires employers to mount each emergency electric operating device in a secured compartment and label the device with instructions for its use. After installing a suspension wire rope, paragraphs (f)(7)(vi) and (f)(7)(vii) mandate that employers attach a corrosion-resistant tag with specified information to one of the wire rope fastenings if the rope is to remain at one location. In addition, paragraph (f)(7)(viii) requires employers who resocket a wire rope to either stamp specified information on the original tag or put that information on a supplemental tag and attach it to the fastening.
Paragraphs (g)(2)(i) and (g)(2)(ii) require that building owners, at least annually, have a competent person: Inspect the supporting structures of their buildings; inspect and, if necessary, test the components of the powered platforms, including control systems; inspect/test components subject to wear (e.g., wire ropes, bearings, gears, and governors); and certify these inspections and tests. Under paragraph (g)(2)(iii), building owners must maintain and, on request, disclose to OSHA a written certification record of these inspections/tests. This record must include the date of the inspection/test, the signature of the competent person who performed it, and the number/identifier of the building support structure and equipment inspected/tested.
Paragraph (g)(3)(i) mandates that building owners have a competent person inspect and, if necessary, test each powered platform facility according to the manufacturer's recommendations every 30 days, or prior to use if the work cycle is less than 30 days. Under paragraph (g)(3)(ii), building owners must maintain and, on request, disclose to the Agency a written certification record of these inspections/tests. This record is to include the date of the inspection/test, the signature of the competent person who performed it, and the number/identifier of the powered platform facility inspected/tested.
According to paragraph (g)(5)(iii), building owners must have a competent person thoroughly inspect suspension wire ropes for a number of specified conditions once a month, or before placing the wire ropes into service if the ropes are inactive for 30 days or longer. Paragraph (g)(5)(v) requires building owners to maintain and, on request, disclose to OSHA a written certification record of these monthly inspections; this record must consist of the date of the inspection, the signature of the competent person who performed it, and the number/identifier of the wire rope inspected.
Paragraph (i)(1)(ii) requires that all workers who operate working platforms be trained in the following: (A) Recognition of, and preventive measures for, the safety hazards associated with their individual work tasks; (B) general recognition and prevention of safety hazards associated with the use of working platforms; (C) emergency action plan procedures required in paragraph (e)(9) of this section; (D) work procedures required in paragraph (i)(1)((iv) of this section; (E) personal fall arrest system inspection, care, use and system performance. Paragraph (1)(1)(iii) requires that training of workers in the operation and inspection of working platforms be performed by a competent person. Paragraph (i)(1)(iv) requires that written work procedures for the operation, safe use and inspection of working platforms be provided for worker training.
Upon completion of this training, paragraph (i)(1)(v) specifies that employers must prepare a written certification that includes the identity of the worker trained, the signature of the employer or the trainer, and the date the worker completed the training. In addition, the employer must maintain a worker's training certificate for the duration of their employment and, on request, make it available to OSHA.
Emergency action plans allow employers and workers to anticipate, and effectively respond to, emergencies that may arise during powered platform operations. Affixing load rating plates to suspended units, instructions to emergency electric operating devices, and tags to wire rope fasteners prevent workplace injuries by providing information to employers and workers regarding the conditions under which they can safely operate these system components. Requiring building owners to establish and maintain written certification of inspections and testing conducted on the supporting structures of buildings, powered platform systems, and suspension wire ropes provides employers and workers with assurance that they can operate safely from the buildings using equipment that is in safe operating condition.
OSHA has a particular interest in comments on the following issues:
• Whether the proposed information collection requirements are necessary for the proper performance of the Agency's functions, including whether the information is useful;
• The accuracy of OSHA's estimate of the burden (time and costs) of the information collection requirements, including the validity of the methodology and assumptions used;
• The quality, utility, and clarity of the information collected; and
• Ways to minimize the burden on employers who must comply; for example, by using automated or other technological information collection and transmission techniques.
OSHA is requesting that OMB extend its approval of the information collection requirements contained in the Standard on Powered Platforms for Building Maintenance (29 CFR 1910.66). The Agency is requesting an adjustment decrease in the number of burden hours from 135,656 to 130,764, a total decrease of 4,892 burden hours. The decrease is due to the removal of burden hours related to training. The Agency will summarize the comments submitted in response to this notice and will include this summary in the request to OMB.
You may submit comments in response to this document as follows: (1) Electronically at
Because of security procedures, the use of regular mail may cause a significant delay in the receipt of comments. For information about security procedures concerning the delivery of materials by hand, express delivery, messenger, or courier service, please contact the OSHA Docket Office at (202) 693-2350, (TTY (877) 889-5627).
Comments and submissions are posted without change at
David Michaels, Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and Health, directed the preparation of this notice. The authority for this notice is the Paperwork Reduction Act of 1995 (44 U.S.C. 3506
Signed at Washington, DC, on February 12, 2014.
Office of Management and Budget.
Revisions to Appendix C of OMB Circular A-94.
The Office of Management and Budget revised Circular A-94 in 1992. The revised Circular specified certain discount rates to be updated annually when the interest rate and inflation assumptions used to prepare the Budget of the United States Government were changed. These discount rates are found in Appendix C of the revised Circular. The updated discount rates are shown below. The discount rates in Appendix C are to be used for cost-effectiveness analysis, including lease-purchase analysis, as specified in the revised Circular. They do not apply to regulatory analysis.
The revised discount rates will be in effect through December 2014.
Gideon F. Lukens, Office of Economic Policy, Office of Management and Budget, (202) 395-3316.
Analyses of programs with terms different from those presented above may use a linear interpolation. For example, a four-year project can be evaluated with a rate equal to the average of the three-year and five-year rates. Programs with durations longer than 30 years may use the 30-year interest rate.
Military Compensation and Retirement Modernization Commission.
Notice of Public Meetings and Town Hall Meeting.
The Military Compensation and Retirement Modernization Commission (Commission) was established by National Defense Authorization Act, FY 2013. Pursuant to the Act, the Commission is holding public hearings and a town hall in order to solicit comments from the general public and select experts on the modernization of the military compensation and retirement systems.
The hearings and town hall will be held Tuesday, February 25, 2014.
The hearings and town hall will be held at the Embassy Suites Fayetteville Fort Bragg, 4760 Lake Valley Drive, Fayetteville, North Carolina 28303.
Christopher Nuneviller, Associate Director, Military Compensation and Retirement Modernization Commission, PO Box 13170, Arlington VA 22209, telephone 703-692-2080, fax 703-697-8330, email
The Military Compensation and Retirement Modernization Commission (Commission) was established by the National Defense Authorization Act FY 2013, Public Law 112-239, § 671, (amended by National Defense Authorization Act FY 2014, Pub. L. 113-66, § 1095). The Commission will conduct public hearings and town halls across the United States and on select military installations internationally in order to solicit comments on the modernization of the military compensation and retirement systems. The Commission seeks the views of service members, retirees, their beneficiaries and other interested parties regarding pay, retirement, health benefits and quality of life programs of the Uniformed Services. The Commission will hear from senior commanders of local military commands and their senior enlisted advisors, unit commanders and their family support groups, local medical and education community representatives, and other quality of life organizations. These meetings sites will be accessible to members of the general public including individuals with disabilities.
On February 25, 2014, the Commission will hold public hearings from 10:00 a.m. until 5:00 p.m., and a public town hall meeting from 7:00 p.m. until 9:00 p.m.
The Panel Testimony heard on Tuesday, February 25, 2014, will consist of:
a. Brief opening remarks by the Chairman and one or more of the Commissioners,
b. brief opening remarks by each panelist, and
c. questions posed by the Chairman and Commissioners to the panelists.
On the evening of Tuesday, February 25, 2014, the Chairman and Commissioners will hear from the public. Attendees will be given an opportunity to address the Chairman and Commissioners and relay to them their experience and comments.
Due to the deliberative, nascent and formative nature of the Commission's work, the Commissioners are unable to discuss their thoughts, plans or intentions for specific recommendations that will ultimately be made to the President and Congress.
The public hearings will be transcribed and placed on the Commission's Web site. In addition to public hearings, and due to the essential need for input from the beneficiaries, the Commission is accepting and strongly encourages comments and other submissions on its Web site (
National Transportation Safety Board (NTSB).
Notice.
In compliance with the Paperwork Reduction Act (PRA), this notice announces the NTSB is submitting an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for generic approval of witness and passenger questionnaires. This ICR is the second notice, as required by OMB regulations concerning approvals of information collections. This notice again describes the nature of the information collection and its expected burden and advises the public it may submit comments on this proposed generic information collection to the OMB desk officer for the NTSB.
Submit written comments regarding this proposed plan for the collection of information by March 20, 2014.
Interested members of the public may submit written comments on the collection of information to the OMB Desk Officer for the NTSB at Office of Management and Budget, 725 17th Street NW., Washington, DC 20503, or via fax: 202-395-5806, (this is not a toll-free number), or email:
David Tochen, NTSB General Counsel, at (202) 314-6080.
In accordance with OMB regulations that require this Notice for proposed ICRs, as well as OMB guidance concerning generic approval of plans for information collections, the NTSB herein notifies the public that it may submit comments on this proposed ICR to the Office of Management and Budget. 5 CFR 1320.10.
On May 28, 2010, Administrator, Office of Information and Regulatory Affairs (OIRA), OMB, issued a memorandum to the Heads of Executive Departments and Agencies, and Independent Regulatory Agencies, providing instructions concerning how agencies can obtain generic OMB clearances for information collections in certain circumstances.
A generic ICR is a request for OMB approval of a plan for conducting more than one information collection using very similar methods when (1) the need for and the overall practical utility of the data collection can be evaluated in advance, as part of the review of the proposed plan, but (2) the agency cannot determine the details of the specific individual collections until a later time.
The NTSB's need to obtain information immediately following a transportation event it is investigating under 49 U.S.C. 1131 is critical. When numerous witnesses observe a transportation event, the most effective and timely manner in which the NTSB can obtain first-hand observations is via distributing questionnaires to all witnesses the NTSB can locate.
This type of information collection is appropriate for generic approval under the applicable OMB guidance. Based on its investigation of previous transportation events, the NTSB can attest to the utility and value of collecting information via witness questionnaires. By distributing such questionnaires, the NTSB will gather information concerning where the witness was located at the time of the event, whether the witness needed medical attention, and what type of assistance the witness may have received during and immediately following the event. Responses to such questions may help the NTSB in determining the probable cause of the transportation event, and will likely also assist the NTSB in issuing safety recommendations to mitigate the effects of future transportation occurrences. In addition, collection of such questionnaires may help ensure the effectiveness of its family assistance activities.
The NTSB customizes each questionnaire to ensure it requests information specific to the particular event the NTSB is investigating. Consistent with the OMB guidance concerning generic approvals, the NTSB will not be able to finalize draft questionnaires specific to each event until the event has occurred. Often, questionnaires include a diagram of the aircraft, rail car, bus, vessel, or other vehicle involved in the event, and requests the respondent pinpoint his or her location by drawing on the diagram. In addition, the questionnaire may include questions concerning life preservers or other safety devices and equipment or other evacuation aspects specific to over-water events, if the occurrence involved such a circumstance. These types of questions are obviously unique to the specific investigation, and impossible to know prior to the occurrence of the event. Overall, the types of information the NTSB will solicit in its witness questionnaires is appropriate for a generic approval for the information collection.
The applicable OMB memorandum instructs agencies to provide specific information in the supporting statements describing the information collections. In particular, the supporting statements should include the following:
• The method of collection and, if statistical methods will be used, a discussion of the statistical methodology;
• The category (or categories) of respondents;
• The estimated “burden cap,” i.e., the maximum number of burden hours (per year) for the specific information collections, and against which burden will be charged for each collection actually used;
• The agency's plans for how it will use the information collected;
• The agency' plans to obtain public input regarding the specific information collections (i.e., consultation); ad
• The agency's internal procedures to ensure that the specific collections comply with the PRA, applicable regulations, and the terms of the generic clearance.
The NTSB will collect the information by transmitting the questionnaire to witnesses of the event, including surviving passengers. Depending on the circumstances, such transmission may occur via hand delivery, electronic mail, facsimile transmission, postal mail, or express mail, or a combination of methods. Respondents will be provided instructions concerning how to return questionnaires to the NTSB investigator who distributed them. The NTSB may create an electronic system on its Web page that provides the agency with the ability to verify whether the respondent was a passenger or a witness to the event. If the NTSB is able to create such a system, the agency may elect to request respondents log in and complete an electronic, web-based questionnaire. While such a system is not available at present, the NTSB nevertheless notes this idea, in case it creates and utilizes such a system in the future.
The NTSB will not use statistical methodology in reaching any conclusions based on the questionnaires. Instead, the NTSB merely will note the total number of respondents in any factual reports for which it uses the questionnaires. Respondents'completion of the questionnaire is voluntary, and the NTSB generally will not contact them more than once to request completion of the questionnaire.
In its questionnaires, the NTSB will generally seek information from two categories of respondents: eyewitnesses who were not passengers of the conveyance involved in the transportation event; and witnesses who were onboard as passengers of the conveyance involved. In most cases, the NTSB will distribute the questionnaires to passengers, as NTSB investigators often interview eyewitnesses verbally at the site of an event, rather than soliciting information from them on a written instrument. However, in some cases, the NTSB may become aware of
In its 2012 Annual Report to Congress, the NTSB stated it launched on eight major accidents and 252 regional or “field” accidents.
The NTSB seeks to emphasize these estimations are approximate, as they are depend on the number of transportation events that occur, and how many passengers and/or witnesses may be available to complete the questionnaire. As the NTSB stated in its first
Witnesses' and passengers' input concerning their recollections of the events preceding, during, and immediately following the transportation event are extremely important to the NTSB. The NTSB creates discipline-specific “groups” for each investigation, and such groups are tasked with investigating a specific aspect of the occurrence. Often, the NTSB creates a survival factors group, which investigates how the circumstances of an event affected the likelihood of passengers and crewmembers surviving the event. This group also examines what, if any, changes could occur to improve the likelihood of survival and/or mitigate the effects of the occurrence.
In practical terms, the NTSB uses the information it collects in completed questionnaires by identifying trends in responses to the questions on the questionnaires. For example, if a majority of respondents indicate they experienced hardship in evacuating an aircraft, rail car, bus, vessel, or other vehicle following an event due to problems with the evacuation route or emergency door, the NTSB would note this data in its factual report summarizing the questionnaires. The NTSB may then utilize this identification of the trend to make a safety recommendation to improve evacuation methods and thereby improve transportation safety and likelihood of survival. Similarly, if a majority of respondents who are eyewitnesses to a transportation event report observing a specific unusual aspect immediately prior to the event, this information may assist the NTSB with determining the probable cause of the occurrence. For example, eyewitnesses who complete a questionnaire and state they observed smoke from a train's engine or from a specific part of an aircraft before a crash can provide information to help the NTSB focus its investigation and determine the probable cause.
Overall, the information the NTSB will receive from completed questionnaires is important to the NTSB. The NTSB will use the information to improve transportation safety by determining the probable cause of the event, mitigating the effects of the event, issuing safety recommendations, fulfilling its family assistance responsibilities, or all of these activities.
The NTSB does not generally obtain public input concerning the scope of, or specific questions on, the witness or passenger questionnaires it uses. However, the NTSB utilizes a party process for each investigation.
Lastly, the OMB memorandum describing generic clearances recommends agencies describe the procedures it will undertake to ensure information collections to which the generic clearance applies will comply with the Paperwork Reduction Act, applicable regulations, and the terms provided in the generic clearance. The NTSB Office of General Counsel plans to provide internal guidance to agency personnel, consisting of this publication, as well as the OMB memorandum discussing generic clearances, upon OMB approval of the clearance. The internal guidance will include specific instructions concerning use of witness and passenger questionnaires, and explain the applicable provisions of the Paperwork Reduction Act and its implementing regulations. The NTSB will also ensure its modal office directors are aware of the generic clearance, and its terms, and direct investigators to contact the NTSB Office of General Counsel to coordinate the dissemination of witness and/or passenger questionnaires. Given the small size of the NTSB, the agency believes it will be able to communicate the terms of compliance with the Paperwork Reduction Act to all investigators who may need to solicit feedback from witnesses and/or passengers via questionnaires.
The NTSB has carefully reviewed questionnaires it has used previously to obtain information from witnesses and passengers. The NTSB assures the public that these questionnaires have used plain, coherent, and unambiguous terminology in its requests for information. In addition, the questionnaires are not duplicative of other agencies' collections of information, because in most instances, the NTSB, by statute, maintains priority over other agencies during a transportation accident investigation; therefore, any information collection that another agency might undertake must be approved in advance by the NTSB investigator-in-charge (IIC). The
In general, the NTSB believes the questionnaires will impose a minimal burden on respondents: the NTSB estimates that each respondent will spend approximately 30 to 45 minutes in completing each questionnaire. The NTSB estimates that a maximum of 650 respondents per year would complete a questionnaire. Although the NTSB may distribute questionnaires to perhaps as many as 1,300 people, historic response rates indicate only 50 percent of the questionnaires will be returned completed. However, the NTSB again notes this number will vary, given the unpredictable nature of the frequency of transportation events.
In accordance with 44 U.S.C. 3506(c)(2)(A), the NTSB seeks feedback from the public concerning this proposed plan for information collection. In particular, the NTSB asks the public to evaluate whether the proposed collection of information is necessary; to assess the accuracy of the NTSB's burden estimate; to comment on how to enhance the quality, utility, and clarity of the information to be collected; and to comment on how the NTSB might minimize the burden of the collection of information.
The NTSB will carefully consider all feedback it receives in response to this notice. As described above, obtaining the information the NTSB seeks on these questionnaires in a timely manner is important to NTSB investigations; therefore, obtaining approval from OIRA for these collections of information on a generic basis is a priority for the NTSB.
Peace Corps.
60-Day notice and request for comments.
The Peace Corps will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval. The purpose of this notice is to allow 30 days for public comment on the new information collection. We are conducting this process in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35).
Comments regarding this collection must be received on or before March 20, 2014.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name/or OMB approval number and should be sent via email to:
Denora Miller, FOIA/Privacy Act Officer, Peace Corps, 1111 20th Street NW., Washington, DC 20526, (202) 692-1236, or email at
The information collected by the Volunteer Application is used by the Peace Corps to collect essential information from individuals, including technical and language skills, and availability for Peace Corps service. The Peace Corps will be changing its application process to better match applicants to programs based on their skills and interests. Due to this change in the way applicants are processed and an overall agency effort to reduce the burden on applicants by only asking the most essential questions, the agency is developing a new application.
Notice is hereby given that the Railroad Retirement Board will hold a meeting on February 26, 2014, 10:00 a.m. at the Board's meeting room on the 8th floor of its headquarters building, 844 North Rush Street, Chicago, Illinois 60611. The agenda for this meeting follows:
(1) Executive Committee Reports
The person to contact for more information is Martha P. Rico, Secretary to the Board, Phone No. 312-751-4920.
Notice of Request for Information.
On June 14, 2013, the President issued a Memorandum to the heads of executive departments and agencies on the subject of spectrum policy (
Responses must be received by March 20, 2014 to be considered.
You may submit comments by any of the following methods:
•
•
•
Tom Power, (202) 456-4444,
In his June 14, 2013, Memorandum on spectrum policy, “
To help implement these goals, the Memorandum established a Spectrum Policy Team. Among its responsibilities, the Spectrum Policy Team shall make recommendations to the President “regarding market-based or other approaches that could give agencies greater incentive to share or relinquish spectrum, while protecting the mission capabilities of existing and future systems that rely on spectrum use.” The Memorandum directed the Spectrum Policy Team to consider certain proposals made by the President's Council of Advisors on Science and Technology in its July 2012 report, “
The Spectrum Policy Team tasked a federally funded research and development center, the Science and Technology Policy Institute (STPI), to review publicly available analyses and proposals regarding incentives for agencies to share or relinquish spectrum. STPI has prepared a report, available at
The STPI report identifies nine major approaches to providing incentives to Federal agencies to share or relinquish spectrum, representing a variety of paths to satisfying the increasing demands for spectrum capacity from both government and commercial users. These approaches are grouped into four types of mechanisms that could be considered, separately or in some combination:
(1) Spectrum user fees, payable by agencies based on some valuation of their spectrum assignments.
(2) A spectrum fund that agencies could draw from to plan and execute spectrum relocation and sharing strategies.
(3) Spectrum property rights, where spectrum assignments to agencies could include the authority to further assign or share those rights with wireless carriers and other third parties in return for compensation paid directly to the agency.
(4) Command-and-control, where a central authority such as the National Telecommunications and Information Administration (NTIA) or the Office of Management and Budget (OMB) would be given greater authority over relocation and sharing decisions.
In addition to addressing these mechanisms, commenters are requested to identify other incentive-based measures that could promote spectrum sharing or relinquishment. Commenters should address the merits of each mechanism, including implementation challenges and the relative advantages and disadvantages, assuming any implementation challenges were overcome.
Without limiting the foregoing, commenters should consider the following:
(A) With respect to spectrum user fees, what are the lessons learned from the United Kingdom's experience as well as any comparable efforts in other countries? To the extent that Federal agencies seek spectrum assignments based on mission-based needs, how would the imposition of user fees affect agency demand for spectrum? How would a system of spectrum user fees operate in the context of the traditional Federal appropriations process?
(B) With respect to a spectrum fund, what are alternative means to fund agency planning, research, and development? If the funding is to come from subsequent auctions of the spectrum band in question, how would agencies assess the potential risk of not being reimbursed for planning costs given that the plans may not be approved or implemented as expected? Likewise, how would such a fund be financially supported and used to promote relinquishment or sharing of bands that could be put to innovative and productive commercial uses without auctioning (e.g. unlicensed uses)? What are ways that a spectrum fund can provide a true incentive to agencies, and not simply reimburse them for costs incurred? Likewise, what is the best way to ensure that disbursements to an agency from a spectrum fund are not simply offset by a corresponding deduction from the agency's budget for the following fiscal year, thus negating the incentive?
(C) With respect to spectrum property rights, how would the introduction of such an approach affect mission capabilities? To the extent that a property right approach provides an incentive to share or relinquish spectrum already acquired, what corresponding conditions, if any, should be imposed on the acquisition of spectrum rights by one or more agencies? What are the practical or legal limitations that would affect the likely benefits of this approach related to spectrum efficiency, operational
(D) With respect to a command-and-control approach, how would efficiency gains be measured and what additional resources, if any, would be required? What kind of additional authority and resources would NTIA or OMB need to effectively implement this approach?
(E) With respect to any approach, what are the means to ensure effective coordination among agencies, such that their collective efforts are brought to bear most productively, especially in the specific bands valued by the private sector? What approaches are most conducive to or dependent on spectrum sharing? What technological and logistical challenges need to be overcome and how significant are those challenges?
(F) H.R. 3674, legislation currently pending in the House of Representatives (
Securities and Exchange Commission (“Commission”).
Notice of an application for an order under section 6(c) of the Investment Company Act of 1940 (“Act”) for an exemption from sections 2(a)(32), 5(a)(1), 22(d) and 22(e) of the Act and rule 22c-1 under the Act, under sections 6(c) and 17(b) of the Act for an exemption from sections 17(a)(1) and (a)(2) of the Act, and under section 12(d)(1)(J) of the Act for an exemption from sections 12(d)(1)(A) and (B) of the Act.
Acacia Asset Management LLC (“Acacia”) and Acacia Trust (the “Trust”).
Applicants request an order that permits: (a) Actively-managed series of certain open-end management investment companies to issue shares (“Shares”) redeemable in large aggregations only (“Creation Units”); (b) secondary market transactions in Shares to occur at negotiated market prices; (c) certain series to pay redemption proceeds, under certain circumstances, more than seven days from the tender of Shares for redemption; (d) certain affiliated persons of the series to deposit securities into, and receive securities from, the series in connection with the purchase and redemption of Creation Units; and (e) certain registered management investment companies and unit investment trusts outside of the same group of investment companies as the series to acquire Shares.
Filing Dates: The application was filed on November 15, 2013, and amended on February 10, 2014.
An order granting the requested relief will be issued unless the Commission orders a hearing. Interested persons may request a hearing by writing to the Commission's Secretary and serving applicants with a copy of the request, personally or by mail. Hearing requests should be received by the Commission by 5:30 p.m. on March 10, 2014, and should be accompanied by proof of service on applicants, in the form of an affidavit or, for lawyers, a certificate of service. Hearing requests should state the nature of the writer's interest, the reason for the request, and the issues contested. Persons who wish to be notified of a hearing may request notification by writing to the Commission's Secretary.
Elizabeth M. Murphy, Secretary, U.S. Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090. Applicants, 825 Third Avenue, 35th Floor, New York, New York 10022.
Christine Y. Greenlees, Senior Counsel, at (202) 551-6879 or David P. Bartels, Branch Chief, at (202) 551-6821 (Division of Investment Management, Chief Counsel's Office).
The following is a summary of the application. The complete application may be obtained via the Commission's Web site by searching for the file number, or for an applicant using the Company name box, at
1. The Trust is a statutory trust organized under the laws of Delaware and will register with the Commission as an open-end management investment company. Applicants currently intend that the initial series of the Trust will be the Acacia Ultra Short ETF (the “Initial Fund”), which will seek current income, consistent with the preservation of capital and daily liquidity. Applicants state that the Initial Fund will invest primarily in fixed income securities with ultra-short maturities, including U.S. dollar-denominated investment grade debt securities, government securities and/or repurchase agreements.
2. Acacia, a Delaware limited liability company that will be registered with the Commission as an investment adviser under the Investment Adviser Act of 1940 (“Advisers Act”), will be the investment adviser to the Initial Fund. The Advisor (as defined below) may enter into sub-advisory agreements with investment advisers to act as sub-advisors with respect to the Funds (as defined below) (each a “Sub-Advisor”). Applicants state that any Sub-Advisor will be registered, or not subject to registration, under the Advisers Act. A registered broker-dealer (“Broker”) under the Securities Exchange Act of 1934 (the “Exchange Act”), will be selected and approved by the Board (as defined below) to act as the distributor and principal underwriter of the Funds (the “Distributor”).
3. Applicants request that the order apply to the Initial Fund and any future series of the Trust or of any other open-end management investment companies that may utilize active management investment strategies (collectively, “Future Funds”). Any Future Fund will (a) be advised by Acacia or an entity controlling, controlled by, or under common control with Acacia (Acacia and each such other entity and any successor thereto included in the term “Advisor”),
4. Applicants request that any exemption under section 12(d)(1)(J) apply to: (1) With respect to section 12(d)(1)(B), any Fund that is currently or subsequently part of the same “group of investment companies” as the Initial Fund within the meaning of section 12(d)(1)(G)(ii) of the Act as well as any principal underwriter for the Fund and any Brokers selling Shares of a Fund to an Investing Fund (as defined below); and (2) with respect to section 12(d)(1)(A), each management investment company or unit investment trust registered under the Act that is not part of the same “group of investment companies” as the Funds, and that enters into a FOF Participation Agreement (as defined below) to acquire Shares of a Fund (such management investment companies, “Investing Management Companies,” such unit investment trusts, “Investing Trusts,” and Investing Management Companies and Investing Trusts together, “Investing Funds”). Investing Funds do not include the Funds.
5. Applicants anticipate that a Creation Unit will consist of at least 25,000 Shares. Applicants anticipate that the trading price of a Share may range from $10 to $1,000. All orders to purchase Creation Units must be placed with the Distributor by or through a party that has entered into a participant agreement with the Distributor and the transfer agent of the Fund (“Authorized Participant”) with respect to the creation and redemption of Creation Units. An Authorized Participant is either: (a) A Broker or other participant in the Continuous Net Settlement System of the National Securities Clearing Corporation (“NSCC”), a clearing agency registered with the Commission and affiliated with the Depository Trust Company (“DTC”), or (b) a participant in the DTC (“DTC Participant”).
6. In order to keep costs low and permit each Fund to be as fully invested as possible, Shares will be purchased and redeemed in Creation Units and generally on an in-kind basis. Except where the purchase or redemption will include cash under the limited circumstances specified below, purchasers will be required to purchase Creation Units by making an in-kind deposit of specified instruments (“Deposit Instruments”), and shareholders redeeming their Shares will receive an in-kind transfer of specified instruments (“Redemption Instruments”).
7. Purchases and redemptions of Creation Units may be made in whole or in part on a cash basis, rather than in kind, solely under the following circumstances: (a) To the extent there is a Cash Amount, as described above; (b) if, on a given Business Day, a Fund announces before the open of trading that all purchases, all redemptions or all purchases and redemptions on that day will be made entirely in cash; (c) if, upon receiving a purchase or redemption order from an Authorized Participant, a Fund determines to require the purchase or redemption, as applicable, to be made entirely in cash; (d) if, on a given Business Day, a Fund requires all Authorized Participants purchasing or redeeming Shares on that day to deposit or receive (as applicable) cash in lieu of some or all of the Deposit Instruments or Redemption Instruments, respectively, solely because: (i) Such instruments are not eligible for transfer through either the NSCC or DTC; or (ii) in the case of Funds holding non-U.S. investment (“Global Funds”), such instruments are not eligible for trading due to local trading restrictions, local restrictions on securities transfers or other similar circumstances; or (e) if a Fund permits an Authorized Participant to deposit or receive (as applicable) cash in lieu of some or all of the Deposit Instruments or Redemption Instruments, respectively, solely because: (i) Such instruments are, in the case of the purchase of a Creation Unit, not available in sufficient quantity; (ii) such instruments are not eligible for trading by an Authorized Participant or the
8. Each Business Day, before the open of trading on a national securities exchange, as defined in section 2(a)(26) of the Act (“Stock Exchange”), on which Shares are listed, each Fund will cause to be published through the NSCC the names and quantities of the instruments comprising the Creation Basket, as well as the estimated Cash Amount (if any), for that day. The published Creation Basket will apply until a new Creation Basket is announced on the following Business Day, and there will be no intra-day changes to the Creation Basket except to correct errors in the published Creation Basket. The Stock Exchange will disseminate every 15 seconds throughout the trading day an amount representing, on a per Share basis, the sum of the current value of the Portfolio Instruments that were publicly disclosed prior to the commencement of trading in Shares on the Stock Exchange.
9. A Fund may recoup the settlement costs charged by NSCC and DTC by imposing a transaction fee on investors purchasing or redeeming Creation Units (the “Transaction Fee”). The Transaction Fee will be borne only by purchasers and redeemers of Creation Units and will be limited to amounts that have been determined appropriate by the Advisor to defray the transaction expenses that will be incurred by a Fund when an investor purchases or redeems Creation Units.
10. Shares will be listed and traded at negotiated prices on a Stock Exchange and traded in the secondary market. Applicants expect that Stock Exchange specialists or market makers (“Market Makers”) will be assigned to Shares. The price of Shares trading on the Stock Exchange will be based on a current bid/offer in the secondary market. Transactions involving the purchases and sales of Shares on the Stock Exchange will be subject to customary brokerage commissions and charges.
11. Applicants expect that purchasers of Creation Units will include institutional investors and arbitrageurs. Specialists or Market Makers, acting in their unique role to provide a fair and orderly secondary market for Shares, also may purchase Creation Units for use in their own market making activities.
12. Shares will not be individually redeemable and owners of Shares may acquire those Shares from a Fund, or tender such shares for redemption to the Fund, in Creation Units only. To redeem, an investor must accumulate enough Shares to constitute a Creation Unit. Redemption requests must be placed by or through an Authorized Participant.
13. Neither the Trust nor any Fund will be marketed or otherwise held out as a “mutual fund.” Instead, each Fund will be marketed as an “actively managed exchange-traded fund”. In any advertising material where features of obtaining, buying or selling Shares traded on the Stock Exchange are described, there will be an appropriate statement to the effect that Shares are not individually redeemable.
14. The Funds' Web site, which will be publicly available prior to the public offering of Shares, will include a Prospectus and additional quantitative information updated on a daily basis, including, on a per Share basis for each Fund, the prior Business Day's NAV and the market closing price or mid-point of the bid/ask spread at the time of the calculation of such NAV (“Bid/Ask Price”), and a calculation of the premium or discount of the market closing price or Bid/Ask Price against such NAV. On each Business Day, before commencement of trading in Shares on the Stock Exchange, the Fund will disclose on its Web site the identities and quantities of the Portfolio Instruments held by the Fund (including any short positions held in securities (“Short Positions”)) that will form the basis for the Fund's calculation of NAV at the end of the Business Day.
1. Applicants request an order under section 6(c) of the Act for an exemption from sections 2(a)(32), 5(a)(1), 22(d) and 22(e) of the Act and rule 22c-1 under the Act, under sections 6(c) and 17(b) of the Act for an exemption from sections 17(a)(1) and 17(a)(2) of the Act, and under section 12(d)(1)(J) of the Act for an exemption from sections 12(d)(1)(A) and (B) of the Act.
2. Section 6(c) of the Act provides that the Commission may exempt any person, security or transaction, or any class of persons, securities or transactions, from any provisions of the Act, if and to the extent that such exemption is necessary or appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Act. Section 17(b) of the Act authorizes the Commission to exempt a proposed transaction from section 17(a) of the Act if evidence establishes that the terms of the transaction, including the consideration to be paid or received, are reasonable and fair and do not involve overreaching on the part of any person concerned, and the proposed transaction is consistent with the policies of the registered investment company and the general provisions of the Act. Section 12(d)(1)(J) of the Act
3. Section 5(a)(1) of the Act defines an “open-end company” as a management investment company that is offering for sale or has outstanding any redeemable security of which it is the issuer. Section 2(a)(32) of the Act defines a redeemable security as any security, other than short-term paper, under the terms of which the holder, upon its presentation to the issuer, is entitled to receive approximately a proportionate share of the issuer's current net assets, or the cash equivalent. Because Shares will not be individually redeemable, applicants request an order that would permit each Fund to redeem Shares in Creation Units only. Applicants state that investors may purchase Shares in Creation Units from each Fund and redeem Creation Units from each Fund. Applicants further state that because the market price of Creation Units will be disciplined by arbitrage opportunities, investors should be able to sell Shares in the secondary market at prices that do not vary materially from their NAV.
4. Section 22(d) of the Act, among other things, prohibits a dealer from selling a redeemable security that is currently being offered to the public by or through a principal underwriter, except at a current public offering price described in the prospectus. Rule 22c-1 under the Act generally requires that a dealer selling, redeeming, or repurchasing a redeemable security do so only at a price based on its NAV. Applicants state that secondary market trading in Shares will take place at negotiated prices, not at a current offering price described in the Prospectus, and not at a price based on NAV. Thus, purchases and sales of Shares in the secondary market will not comply with section 22(d) of the Act and rule 22c-1 under the Act. Applicants request an exemption under section 6(c) from these provisions.
5. Applicants assert that the concerns sought to be addressed by section 22(d) of the Act and rule 22c-1 under the Act with respect to pricing are equally satisfied by the proposed method of pricing Shares. Applicants maintain that while there is little legislative history regarding section 22(d), its provisions, as well as those of rule 22c-1, appear to have been designed to (a) prevent dilution caused by certain riskless-trading schemes by principal underwriters and contract dealers, (b) prevent unjust discrimination or preferential treatment among buyers resulting from sales at different prices, and (c) assure an orderly distribution system of investment company shares by eliminating price competition from brokers offering shares at less than the published sales price and repurchasing shares at more than the published redemption price.
6. Applicants believe that none of these purposes will be thwarted by permitting Shares to trade in the secondary market at negotiated prices. Applicants state that (a) secondary market trading in Shares does not involve the Funds as parties and cannot result in dilution of an investment in Shares, and (b) to the extent different prices exist during a given trading day, or from day to day, such variances occur as a result of third-party market forces, such as supply and demand. Therefore, applicants assert that secondary market transactions in Shares will not lead to discrimination or preferential treatment among purchasers. Finally, applicants contend that the proposed distribution system will be orderly because arbitrage activity should ensure that the difference between the market price of Shares and their NAV remains narrow.
7. Section 22(e) of the Act generally prohibits a registered investment company from suspending the right of redemption or postponing the date of payment of redemption proceeds for more than seven days after the tender of a security for redemption. Applicants observe that settlement of redemptions of Creation Units of Global Funds is contingent not only on the settlement cycle of the U.S. securities markets but also on the delivery cycles present in foreign markets in which those Funds invest. Applicants have been advised that, under certain circumstances, the delivery cycles for transferring Portfolio Instruments to redeeming investors, coupled with local market holiday schedules, will require a delivery process of up to 14 calendar days. Applicants therefore request relief from section 22(e) in order to provide payment or satisfaction of redemptions within the maximum number of calendar days required for such payment or satisfaction in the principal local markets where transactions in the Portfolio Instruments of each Global Fund customarily clear and settle, but in all cases no later than 14 calendar days following the tender of a Creation Unit.
8. Applicants state that section 22(e) was designed to prevent unreasonable, undisclosed and unforeseen delays in the actual payment of redemption proceeds. Applicants assert that the requested relief will not lead to the problems that section 22(e) was designed to prevent. Applicants state that allowing redemption payments for Creation Units of a Fund to be made within a maximum of 14 calendar days would not be inconsistent with the spirit and intent of section 22(e). Applicants state each Global Fund's statement of additional information (“SAI”) will disclose those local holidays (over the period of at least one year following the date of the SAI), if any, that are expected to prevent the delivery of redemption proceeds in seven calendar days and the maximum number of days needed to deliver the proceeds for each affected Global Fund. Applicants are not seeking relief from section 22(e) with respect to Global Funds that do not affect redemptions in-kind.
9. Section 12(d)(1)(A) of the Act prohibits a registered investment company from acquiring shares of an investment company if the securities represent more than 3% of the total outstanding voting stock of the acquired company, more than 5% of the total assets of the acquiring company, or, together with the securities of any other investment companies, more than 10% of the total assets of the acquiring company. Section 12(d)(1)(B) of the Act prohibits a registered open-end investment company, its principal underwriter, or any other broker or dealer from selling its shares to another investment company if the sale will cause the acquiring company to own more than 3% of the acquired company's voting stock, or if the sale will cause more than 10% of the acquired company's voting stock to be owned by investment companies generally.
10. Applicants request relief to permit Investing Funds to acquire Shares in excess of the limits in section 12(d)(1)(A) of the Act and to permit the Funds, their principal underwriters and any Broker to sell Shares to Investing Funds in excess of the limits in section 12(d)(l)(B) of the Act. Applicants submit
11. Applicants submit that their proposed conditions address any concerns regarding the potential for undue influence. To limit the control that an Investing Fund may have over a Fund, applicants propose a condition prohibiting the adviser of an Investing Management Company (“Investing Fund Advisor”), sponsor of an Investing Trust (“Sponsor”), any person controlling, controlled by, or under common control with the Investing Fund Advisor or Sponsor, and any investment company or issuer that would be an investment company but for sections 3(c)(1) or 3(c)(7) of the Act that is advised or sponsored by the Investing Fund Advisor, the Sponsor, or any person controlling, controlled by, or under common control with the Investing Fund Advisor or Sponsor (“Investing Fund's Advisory Group”) from controlling (individually or in the aggregate) a Fund within the meaning of section 2(a)(9) of the Act. The same prohibition would apply to any sub-adviser to an Investing Management Company (“Investing Fund Sub-Advisor”), any person controlling, controlled by or under common control with the Investing Fund Sub-Advisor, and any investment company or issuer that would be an investment company but for sections 3(c)(1) or 3(c)(7) of the Act (or portion of such investment company or issuer) advised or sponsored by the Investing Fund Sub-Advisor or any person controlling, controlled by or under common control with the Investing Fund Sub-Advisor (“Investing Fund's Sub-Advisory Group”).
12. Applicants propose a condition to ensure that no Investing Fund or Investing Fund Affiliate
13. Applicants propose several conditions to address the potential for layering of fees. Applicants note that the board of directors or trustees of any Investing Management Company, including a majority of the directors or trustees who are not “interested persons” within the meaning of section 2(a)(19) of the Act (“independent directors or trustees”), will be required to find that the advisory fees charged under the contract are based on services provided that will be in addition to, rather than duplicative of, services provided under the advisory contract of any Fund in which the Investing Management Company may invest. Applicants also state that any sales charges and/or service fees charged with respect to shares of an Investing Fund will not exceed the limits applicable to a fund of funds as set forth in NASD Conduct Rule 2830.
14. Applicants submit that the proposed arrangement will not create an overly complex fund structure. Applicants note that a Fund will be prohibited from acquiring securities of any investment company or company relying on section 3(c)(1) or 3(c)(7) of the Act in excess of the limits contained in section 12(d)(1)(A) of the Act, except to the extent permitted by exemptive relief from the Commission permitting the Fund to purchase shares of other investment companies for short-term cash management purposes.
15. To ensure that an Investing Fund is aware of the terms and conditions of the requested order, the Investing Funds must enter into an agreement with the respective Funds (“FOF Participation Agreement”). The FOF Participation Agreement will include an acknowledgement from the Investing Fund that it may rely on the order only to invest in a Fund and not in any other investment company.
16. Section 17(a) of the Act generally prohibits an affiliated person of a registered investment company, or an affiliated person of such a person (“second tier affiliate”), from selling any security to or purchasing any security from the company. Section 2(a)(3) of the Act defines “affiliated person” to include any person directly or indirectly owning, controlling, or holding with power to vote, 5% or more of the outstanding voting securities of the other person and any person directly or indirectly controlling, controlled by, or under common control with, the other person. Section 2(a)(9) of the Act defines “control” as the power to exercise a controlling influence over the management or policies of a company and provides that a control relationship will be presumed where one person owns more than 25% of another person's voting securities. Each Fund may be deemed to be controlled by an Advisor and hence affiliated persons of each other. In addition, the Funds may be deemed to be under common control with any other registered investment company (or series thereof) advised by an Advisor (an “Affiliated Fund”).
17. Applicants request an exemption under sections 6(c) and 17(b) of the Act from sections 17(a)(1) and 17(a)(2) of the Act to permit in-kind purchases and redemptions of Creation Units by persons that are affiliated persons or second tier affiliates of the Funds solely by virtue of one or more of the following: (a) Holding 5% or more, or in excess of 25% of the outstanding Shares of one or more Funds; (b) having an affiliation with a person with an ownership interest described in (a); or (c) holding 5% or more, or more than 25% of the Shares of one or more Affiliated Funds.
18. Applicants assert that no useful purpose would be served by prohibiting such affiliated persons from making in-kind purchases or in-kind redemptions of Shares of a Fund in Creation Units. Absent the unusual circumstances discussed in the application, the Deposit Instruments and Redemption Instruments available for a Fund will be the same for all purchasers and redeemers, respectively, and will correspond
19. Applicants also submit that the sale of Shares to and redemption of Shares from an Investing Fund meets the standards for relief under sections 17(b) and 6(c) of the Act. Applicants note that any consideration paid for the purchase or redemption of Shares directly from a Fund will be based on the NAV of the Fund in accordance with policies and procedures set forth in the Fund's registration statement.
Applicants agree that any order of the Commission granting the requested relief will be subject to the following conditions:
1. As long as a Fund operates in reliance on the requested order, the Shares of the Fund will be listed on a Stock Exchange.
2. Neither the Trust nor any Fund will be advertised or marketed as an open-end investment company or a mutual fund. Any advertising material that describes the purchase or sale of Creation Units or refers to redeemability will prominently disclose that the Shares are not individually redeemable and that owners of the Shares may acquire those Shares from the Fund and tender those Shares for redemption to the Fund in Creation Units only.
3. The Web site for the Funds, which is and will be publicly accessible at no charge, will contain, on a per Share basis, for each Fund the prior Business Day's NAV and the market closing price or Bid/Ask Price, and a calculation of the premium or discount of the market closing price or Bid/Ask Price against such NAV.
4. On each Business Day, before commencement of trading in Shares on the Stock Exchange, the Fund will disclose on its Web site the identities and quantities of the Portfolio Instruments held by the Fund that will form the basis for the Fund's calculation of NAV at the end of the Business Day.
5. The Advisor or any Sub-Advisor, directly or indirectly, will not cause any Authorized Participant (or any investor on whose behalf an Authorized Participant may transact with the Fund) to acquire any Deposit Instrument for the Fund through a transaction in which the Fund could not engage directly.
6. The requested relief to permit ETF operations will expire on the effective date of any Commission rule under the Act that provides relief permitting the operation of actively-managed exchange-traded funds.
1. The members of the Investing Fund's Advisory Group will not control (individually or in the aggregate) a Fund within the meaning of section 2(a)(9) of the Act. The members of the Investing Fund's Sub-Advisory Group will not control (individually or in the aggregate) a Fund within the meaning of section 2(a)(9) of the Act. If, as a result of a decrease in the outstanding voting securities of a Fund, the Investing Fund's Advisory Group or the Investing Fund's Sub-Advisory Group, each in the aggregate, becomes a holder of more than 25 percent of the outstanding voting securities of a Fund, it will vote its Shares of the Fund in the same proportion as the vote of all other holders of the Fund's Shares. This condition does not apply to the Investing Fund's Sub-Advisory Group with respect to a Fund for which the Investing Fund Sub-Advisor or a person controlling, controlled by or under common control with the Investing Fund Sub-Advisor acts as the investment adviser within the meaning of section 2(a)(20)(A) of the Act.
2. No Investing Fund or Investing Fund Affiliate will cause any existing or potential investment by the Investing Fund in a Fund to influence the terms of any services or transactions between the Investing Fund or an Investing Fund Affiliate and the Fund or a Fund Affiliate.
3. The board of directors or trustees of an Investing Management Company, including a majority of the independent directors or trustees, will adopt procedures reasonably designed to ensure that the Investing Fund Advisor and any Investing Fund Sub-Advisor are conducting the investment program of the Investing Management Company without taking into account any consideration received by the Investing Management Company or an Investing Fund Affiliate from a Fund or a Fund Affiliate in connection with any services or transactions.
4. Once an investment by an Investing Fund in the Shares of a Fund exceeds the limit in section 12(d)(1)(A)(i) of the Act, the Board of a Fund, including a majority of the independent directors or trustees, will determine that any consideration paid by the Fund to the Investing Fund or an Investing Fund Affiliate in connection with any services or transactions: (i) Is fair and reasonable in relation to the nature and quality of the services and benefits received by the Fund; (ii) is within the range of consideration that the Fund would be required to pay to another unaffiliated entity in connection with the same services or transactions; and (iii) does not involve overreaching on the part of any person concerned. This condition does not apply with respect to any services or transactions between a Fund and its investment adviser(s), or any person controlling, controlled by or under common control with such investment adviser(s).
5. The Investing Fund Advisor, or Trustee or Sponsor, as applicable, will waive fees otherwise payable to it by the
6. No Investing Fund or Investing Fund Affiliate (except to the extent it is acting in its capacity as an investment adviser to a Fund) will cause a Fund to purchase a security in an Affiliated Underwriting.
7. The Board of a Fund, including a majority of the independent directors or trustees, will adopt procedures reasonably designed to monitor any purchases of securities by the Fund in an Affiliated Underwriting, once an investment by an Investing Fund in the securities of the Fund exceeds the limit of section 12(d)(1)(A)(i) of the Act, including any purchases made directly from an Underwriting Affiliate. The Board will review these purchases periodically, but no less frequently than annually, to determine whether the purchases were influenced by the investment by the Investing Fund in the Fund. The Board will consider, among other things: (i) Whether the purchases were consistent with the investment objectives and policies of the Fund; (ii) how the performance of securities purchased in an Affiliated Underwriting compares to the performance of comparable securities purchased during a comparable period of time in underwritings other than Affiliated Underwritings or to a benchmark such as a comparable market index; and (iii) whether the amount of securities purchased by the Fund in Affiliated Underwritings and the amount purchased directly from an Underwriting Affiliate have changed significantly from prior years. The Board will take any appropriate actions based on its review, including, if appropriate, the institution of procedures designed to assure that purchases of securities in Affiliated Underwritings are in the best interest of shareholders of the Fund.
8. Each Fund will maintain and preserve permanently in an easily accessible place a written copy of the procedures described in the preceding condition, and any modifications to such procedures, and will maintain and preserve for a period of not less than six years from the end of the fiscal year in which any purchase in an Affiliated Underwriting occurred, the first two years in an easily accessible place, a written record of each purchase of securities in Affiliated Underwritings once an investment by an Investing Fund in the securities of the Fund exceeds the limit of section 12(d)(1)(A)(i) of the Act, setting forth from whom the securities were acquired, the identity of the underwriting syndicate's members, the terms of the purchase, and the information or materials upon which the Board's determinations were made.
9. Before investing in a Fund in excess of the limits in section 12(d)(1)(A), an Investing Fund will execute a FOF Participation Agreement with the Fund stating that their respective boards of directors or trustees and their investment advisers, or Trustee and Sponsor, as applicable, understand the terms and conditions of the order, and agree to fulfill their responsibilities under the order. At the time of its investment in Shares of a Fund in excess of the limit in section 12(d)(1)(A)(i), an Investing Fund will notify the Fund of the investment. At such time, the Investing Fund will also transmit to the Fund a list of the names of each Investing Fund Affiliate and Underwriting Affiliate. The Investing Fund will notify the Fund of any changes to the list as soon as reasonably practicable after a change occurs. The Fund and the Investing Fund will maintain and preserve a copy of the order, the FOF Participation Agreement, and the list with any updated information for the duration of the investment and for a period of not less than six years thereafter, the first two years in an easily accessible place.
10. Before approving any advisory contract under section 15 of the Act, the board of directors or trustees of each Investing Management Company, including a majority of the independent directors or trustees, will find that the advisory fees charged under such contract are based on services provided that will be in addition to, rather than duplicative of, the services provided under the advisory contract(s) of any Fund in which the Investing Management Company may invest. These findings and their basis will be recorded fully in the minute books of the appropriate Investing Management Company.
11. Any sales charges and/or service fees charged with respect to shares of an Investing Fund will not exceed the limits applicable to a fund of funds as set forth in NASD Conduct Rule 2830.
12. No Fund relying on the section 12(d)(1) relief will acquire securities of any investment company or company relying on section 3(c)(1) or 3(c)(7) of the Act in excess of the limits contained in section 12(d)(1)(A) of the Act, except to the extent permitted by exemptive relief from the Commission permitting the Fund to purchase shares of other investment companies for short-term cash management purposes.
For the Commission, by the Division of Investment Management, under delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The principal purpose of the change is to permit ICE Clear Europe Clearing Members to post additional categories of securities, including KfW Euro Benchmark Bonds (“KfWs”) and European Investment Bank Euro Area Reference Notes (“EIBs”, together with KfWs, the “New Permitted Cover”) to ICE Clear Europe as permitted cover to meet initial margin, original margin and certain other margin requirements, including delivery margin requirements. The New Permitted Cover will not be accepted to satisfy variation margin requirements or guaranty fund requirements.
In its filing with the Commission, ICE Clear Europe included statements concerning the purpose of and basis for proposing the New Permitted Cover. The text of these statements may be examined at the places specified in Item IV below. ICE Clear Europe has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of these statements.
The purpose of ICE Clear Europe accepting the New Permitted Cover is to provide its Clearing Members with a greater range of high-quality collateral that can be posted to ICE Clear Europe to satisfy certain margin requirements.
ICE Clear Europe believes that the New Permitted Cover is of minimal credit risk comparable to that of other sovereign debt currently accepted by ICE Clear Europe as permitted cover for margin obligations. ICE Clear Europe further believes that the New Permitted Cover has demonstrated low volatility, including in stressed market conditions. Based on its analysis of the New Permitted Cover and its volatility and other characteristics, ICE Clear Europe has established initial valuation haircut levels for the New Permitted Cover, and will review and modify such haircuts from time to time in accordance with the Rules and procedures. In addition, each type of New Permitted Cover may only be used to satisfy margin requirements up to a specified concentration limit, which is subject to review and modification from time to time in accordance with the Rules and procedures. The concentration limit applies on an aggregate basis across all product categories.
Specifically, KfWs and EIBs may only constitute up to 25% of a Clearing Member's total initial and original margin requirement, up to a maximum amount of EUR 30 million. The New Permitted Cover will be subject to a valuation haircut of three percent (3%), except that the New Permitted Cover with a maturity of more than eleven (11) years will be subject to a valuation haircut of five percent (5%).
Consistent with existing ICE Clear Europe haircut policies, an additional haircut will apply where New Permitted Cover is used to cover a margin requirement denominated in a different currency, to cover the exchange rate risk.
For the avoidance of doubt, the New Permitted Cover cannot be used to satisfy variation margin requirements because variation margin must be paid in cash in the currency of the contract. In addition, the New Permitted Cover will not be accepted in respect of guaranty fund requirements.
ICE Clear Europe has identified New Permitted Cover as types of assets that would be appropriate for Clearing Members to post in order to meet initial margin and original margin requirements. ICE Clear Europe believes that accepting the New Permitted Cover is consistent with the requirements of Section 17A of the Act
For the reasons noted above, ICE Clear Europe believes that the proposed rule change and the New Permitted Cover are consistent with the requirements of Section 17A of the Act and regulations thereunder applicable to it.
ICE Clear Europe does not believe the proposed changes to the rules would have any impact, or impose any burden, on competition.
Written comments relating to the proposed changes to the rules have not been solicited or received. ICE Clear Europe will notify the Commission of any written comments received by ICE Clear Europe. The New Permitted Cover has been approved by both the Futures & Options and CDS Risk Committees.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove the proposed rule change or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
All submissions should refer to File Number SR-ICEEU-2014-02. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site (
All comments received will be posted without change; the Commission does not edit personal identifying information from submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-ICEEU-2014-02 and should be submitted on or before March 11, 2014.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On December 13, 2013, The NASDAQ Stock Market LLC (“Nasdaq” or the “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act” or “Exchange Act”)
The Exchange proposes to list and trade Shares of the Fund under Nasdaq Rule 5735, which governs the listing and trading of Managed Fund Shares on the Exchange. The Shares will be offered by AdviserShares Trust (“Trust”). The Trust is registered with the Commission as an investment company.
AdvisorShares Investments, LLC will be the investment adviser (“Adviser”) to the Fund. The Elements Financial Group, LLC will be the investment sub-adviser (“Sub-Adviser”) to the Fund. Foreside Fund Services, LLC (“Distributor”) will be the principal underwriter and distributor of the Fund's Shares. The Bank of New York Mellon will act as the administrator, accounting agent, custodian and transfer agent to the Fund.
The Exchange represents that the Adviser and Sub-Adviser are neither a broker-dealer nor affiliated with a broker-dealer.
According to the Exchange, the Fund's investment objective will be to provide current income and capital appreciation. The Fund will be an actively managed exchange traded fund (“ETF”) that is a “fund of funds” seeking to achieve its investment objective by primarily investing in both long and short positions in other
In seeking to achieve its investment objective, the Fund may also invest directly in U.S.-traded fixed income and equity securities, certain derivatives described below, namely options, futures, and structured notes; and other exchange-traded products (“ETPs”).
The Fund may trade put and call options on securities, securities indices and currencies. The Fund may purchase put and call options on securities to protect against a decline in the market value of the securities in its portfolio or to anticipate an increase in the market value of securities that the Fund may seek to purchase in the future. The Fund may write covered call options on securities as a means of increasing the yield on its assets and as a means of providing limited protection against decreases in its market value. The Fund may purchase and write options on an exchange or over-the-counter.
The Fund may buy and sell futures contracts. The Fund will only enter into futures contracts that are traded on a national futures exchange regulated by the Commodities Futures Trading Commission (“CFTC”).
The Fund may invest in structured notes, which are debt obligations that also contain an embedded derivative component with characteristics that adjust the obligation's risk/return profile. Generally, the performance of a structured note will track that of the underlying debt obligation and the derivative embedded within it. The Fund has the right to receive periodic interest payments from the issuer of the structured notes at an agreed-upon interest rate and a return of the principal at the maturity date.
On a day-to-day basis, the Fund may hold money market instruments,
The Fund may invest in certificates of deposit issued against funds deposited in a bank or savings and loan association. In addition, the Fund may invest in bankers' acceptances, which are short-term credit instruments used to finance commercial transactions.
The Fund also may invest in fixed time deposits, which are bank obligations payable at a stated maturity date and bearing interest at a fixed rate. Additionally, the Fund may invest in commercial paper, which are short-term unsecured promissory notes. The Fund may invest in commercial paper rated A-1 or A-2 by Standard and Poor's Rating Services or Prime-1 or Prime-2 by Moody's Investors Service, Inc. or, if unrated, judged by the Adviser to be of comparable quality. Together, these Other Investments will make up less than 20% of the Fund assets under normal circumstances.
The Fund may not invest more than 25% of the value of its total assets in securities of issuers in any one industry or group of industries. This restriction will not apply to obligations issued or guaranteed by the U.S. government, its agencies or instrumentalities, or securities of other investment companies.
The Fund will not purchase securities of open-end or closed-end investment companies except in compliance with the 1940 Act.
The Fund may hold up to an aggregate amount of 15% of its net assets in illiquid assets (calculated at the time of investment). The Fund will monitor its portfolio liquidity on an ongoing basis to determine whether, in light of current circumstances, an adequate level of liquidity is being maintained, and will consider taking appropriate steps in order to maintain adequate liquidity if, through a change in values, net assets, or other circumstances, more than 15% of the Fund's net assets are held in illiquid assets. Illiquid assets include securities subject to contractual or other restrictions on resale and other instruments that lack readily available markets as determined in accordance with Commission staff guidance.
Additional information regarding the Trust, Fund, and Shares, including
After careful review, the Commission finds that the proposed rule change, as modified by Amendment Nos. 1 and 2, is consistent with the requirements of Section 6 of the Act
The Commission finds that the proposal to list and trade the Shares on the Exchange is consistent with Section 11A(a)(1)(C)(iii) of the Act,
The Commission further believes that the proposal to list and trade the Shares is reasonably designed to promote fair disclosure of information that may be necessary to price the Shares appropriately and to prevent trading when a reasonable degree of transparency cannot be assured. The Commission notes that the Exchange will obtain a representation from the issuer of the Shares that the NAV will be calculated daily and that the NAV and the Disclosed Portfolio will be made available to all market participants at the same time.
In support of this proposal, the Exchange has made representations, including:
(1) The Exchange deems the Shares to be equity securities, thus rendering trading in the Shares subject to the Exchange's existing rules governing the trading of equity securities.
(2) The Shares will be subject to Rule 5735, which sets forth the initial and continued listing criteria applicable to Managed Fund Shares.
(3) The Exchange has appropriate rules to facilitate transactions in the Shares during all trading sessions.
(4) Prior to the commencement of trading, the Exchange will inform its members in an Information Circular of the special characteristics and risks associated with trading the Shares. Specifically, the Information Circular will discuss the following: (a) The procedures for purchases and redemptions of Shares in Creation Units (and that Shares are not individually redeemable); (b) Nasdaq Rule 2111A, which imposes suitability obligations on Nasdaq members with respect to recommending transactions in the Shares to customers; (c) how information regarding the Intraday Indicative Value is disseminated; (d) the risks involved in trading the Shares during the Pre-Market and Post-Market Sessions when an updated Intraday Indicative Value will not be calculated or publicly disseminated; (e) the requirement that members deliver a prospectus to investors purchasing newly issued Shares prior to or concurrently with the confirmation of a transaction; and (f) trading information.
(5) Trading in the Shares will be subject to the existing trading surveillances, administered by both Nasdaq and the Financial Industry Regulatory Authority (“FINRA”) on behalf of the Exchange, which are designed to detect violations of Exchange rules and applicable federal securities laws, and these procedures are adequate to properly monitor Exchange trading of the Shares in all trading sessions and to deter and detect violations of Exchange rules and applicable federal securities laws.
(6) FINRA, on behalf of the Exchange, will communicate as needed regarding trading in the Shares and other exchange-traded securities and instruments held by the Fund with other markets and other entities that are members of the Intermarket Surveillance Group (“ISG”)
(7) For initial and continued listing, the Fund must be in compliance with Rule 10A-3 under the Exchange Act.
(8) A minimum of 100,000 Shares will be outstanding at the commencement of trading on the Exchange.
(9) The Fund may hold up to an aggregate amount of 15% of its net assets in illiquid assets (calculated at the time of investment); will monitor its portfolio liquidity on an ongoing basis to determine whether, in light of current circumstances, an adequate level of liquidity is being maintained; and will consider taking appropriate steps in order to maintain adequate liquidity if, through a change in values, net assets, or other circumstances, more than 15% of the Fund's net assets are held in illiquid assets.
(10) The Fund will not invest in swaps.
(11) The Fund will not invest in leveraged or inverse leveraged ETFs.
(12) The Fund's investments will be consistent with the Fund's investment objective.
Interested persons are invited to submit written data, views, and arguments concerning whether Amendment Nos. 1 and 2 are consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
The Commission finds good cause to approve the proposed rule change, as modified by Amendment Nos. 1 and 2, prior to the thirtieth day after the date of publication of notice in the
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend the Exchange's Pricing Schedule under Section VIII, entitled “NASDAQ OMX PSX FEES,” with respect to execution and routing of orders in securities priced at $1 or more per share.
While the changes proposed herein are effective upon filing, the Exchange has designated that the amendments be operative on February 3, 2014.
The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The purpose of the proposed rule change is to amend the [sic] certain fees and credits for order execution and routing applicable to the use of the order execution and routing services of the NASDAQ OMX PSX System by member organizations for all securities traded at $1 or more per share. Specifically, the Exchange is proposing to amend fees and credits provided for the routing of orders in all securities.
Currently, for PSTG, PSCN, PTFY, PCRT or XCST orders that execute at NASDAQ OMX BX (“BX”) the Exchange provides a credit of $0.0011 per share to the member organization. The Exchange proposes to no longer offer this credit.
Additionally, the Exchange currently charges a member organization entering a PMOP order that executes at the New York Stock Exchange (“NYSE”) $0.0030 per share. The Exchange is proposing to increase the charge assessed for such orders executed at NYSE to $0.0035 per share.
The Exchange also currently charges a member organization $0.0005 per share for entering a PTFY order that executes in a venue other than the NASDAQ OMX PSX (“PSX), NYSE, The Nasdaq Stock Market LLC (“Nasdaq”) or BX. The Exchange is proposing to increase the charge assessed for such orders to $0.0007 per share.
Finally, the Exchange will institute a $0.0007 per share charge for XCST and XDRK orders for shares executed at a venue other than BX. Currently, there is no charge for either XCST or XDRK.
The Exchange believes that its proposal to amend its Pricing Schedule is consistent with Section 6(b) of the Act
The Exchange is proposing modest increase of only $0.0002 per share, from $0.000t [sic] to $0.0007 per share, for a member organization entering a PTFY order that executes in a venue other than the PSX, NYSE, NASDAQ or BX. The Exchange proposes the same $0.0007 per share charge for a member organization entering a XCST or XDRK order that executes in a venue other than the PSX, NYSE, NASDAQ or BX. Currently, there is no charge for such XCST and XDRK orders. These changes are consistent with an equitable allocation of fees and not unfairly discriminatory because it [sic] will eliminate an existing disparity between the fees charged for a PTFY, XCST and XDRK orders that execute in a venue other than the PSX, NYSE, NASDAQ or BX, thereby making the applicable fees consistent. In addition, the change is equitable and not unfairly discriminatory because it affects these similarly situated member organizations in the same way.
The Exchange is proposing a similarly modest increase of only $0.0005 per share, from $0.0030 to $0.0035 per share, for a member organization entering a PMOP order that executes in [sic] the NYSE. This change is consistent with an equitable allocation of fees and not unfairly discriminatory because it will eliminate an existing disparity between the fees charged for a PTFY order executed at NYSE with PMOP orders executed at venues other than NYSE, thereby making the applicable fees consistent. In addition,
The Exchange is also proposing to no longer provide a credit of $0.0011 per share executed at BX to a member organization entering PSTG, PSCN, PTFY, PCRT or XCST orders that execute at BX. These changes are reasonable because the Exchange believes it is no longer necessary to further incentivizes [sic] member organizations to provide displayed quotes and orders on PSX. Additionally, the changes are equitable and not unfairly discriminatory because they affect all similarly situated member organizations in the same way.
The changes with respect to the charges assessed and credits provided for routing of orders in all securities are reasonable because they represent a modest increases [sic] in charges assessed a member organization for PTFY, XCST and XDRK orders that execute at a venue other than BX and for PMOP orders that execute at NYSE, and a modest decreases [sic] in the credits provided to member organizations for PSTG, PSCN, PTFY, PCRT and XCST orders that execute at BX. The Exchange notes that the increase in fees and decrease in credits are designed to incentivize member organizations to provide orders and quotes that execute on PSX. In addition, the change is equitable and not unfairly discriminatory because it affects only those members that opt to use the Exchange's optional routing services.
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act, as amended.
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.
All submissions should refer to File Number SR-Phlx-2014-09. This file number should be included on the subject line if email is used.
To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site (
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The principal purpose of the change is to permit Clearing Members of ICE Clear Europe to post certain Japanese Government Bonds (“JGBs”), Japanese Treasury Bills (“JTBs”) and Japanese Treasury Discount Bills (“JTDBs” together with JGBs and JTBs, the “New Permitted Cover”) to ICE Clear Europe in order to meet initial margin, original margin and certain other margin requirements, including delivery margin requirements. The New Permitted Cover will not be accepted to satisfy variation margin requirements or guaranty fund requirements. ICE Clear Europe commenced accepting the New Permitted Cover as of June 28, 2013.
In its filing with the Commission, ICE Clear Europe included statements concerning the purpose of and basis for proposing the New Permitted Cover. The text of these statements may be examined at the places specified in Item IV below. ICE Clear Europe has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of these statements.
The purpose of ICE Clear Europe accepting the New Permitted Cover is to provide its Clearing Members with a greater range of high-quality collateral that can be posted to ICE Clear Europe to satisfy certain margin requirements.
ICE Clear Europe believes that the New Permitted Cover is of minimal credit risk comparable to that of other sovereign debt currently accepted by ICE Clear Europe as permitted cover for margin obligations. ICE Clear Europe further believes that the New Permitted Cover has demonstrated low volatility, including in stressed market conditions. Based on its analysis of the New Permitted Cover and its volatility and other characteristics, ICE Clear Europe has established initial valuation haircut levels for the New Permitted Cover, and will review and modify such haircuts from time to time in accordance with the Rules and procedures. In addition, each type of New Permitted Cover may only be used to satisfy margin requirements up to a specified concentration limit, which is subject to review and modification from time to time in accordance with the Rules and procedures. The concentration limit applies on an aggregate basis across all product categories.
Specifically, Japanese Government Debt may only constitute up to 10% of a Clearing Member's total initial and original margin requirement, up to a maximum amount of JPY 100 billion. Japanese Government Debt will be subject to a valuation haircut of three percent (3%), except that JGBs with a maturity of more than eleven (11) years will be subject to a valuation haircut of five percent (5%).
Consistent with existing ICE Clear Europe haircut policies, an additional haircut will apply where New Permitted Cover is used to cover a margin requirement denominated in a different currency, to cover the exchange rate risk.
For the avoidance of doubt, the New Permitted Cover cannot be used to satisfy variation margin requirements because variation margin must be paid in cash in the currency of the contract. In addition, the New Permitted Cover will not be accepted in respect of guaranty fund requirements.
ICE Clear Europe has identified New Permitted Cover as types of assets that would be appropriate for Clearing Members to post in order to meet initial margin and original margin requirements. ICE Clear Europe believes that accepting the New Permitted Cover is consistent with the requirements of Section 17A of the Act
For the reasons noted above, ICE Clear Europe believes that the proposed rule change and the New Permitted Cover are consistent with the requirements of Section 17A of the Act and regulations thereunder applicable to it.
ICE Clear Europe does not believe the proposed changes to the rules would have any impact, or impose any burden, on competition.
Written comments relating to the proposed changes to the rules have not been solicited or received. ICE Clear Europe will notify the Commission of any written comments received by ICE Clear Europe. The New Permitted Cover has been approved by both the Futures & Options and CDS Risk Committees.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove the proposed rule change or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
All submissions should refer to File Number SR-ICEEU-2014-01. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site (
All comments received will be posted without change; the Commission does not edit personal identifying information from submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-ICEEU-2014-01 and should be submitted on or before March 11, 2014.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Susquehanna River Basin Commission.
Notice.
The Susquehanna River Basin Commission will hold its regular business meeting on March 6, 2014, in Harrisburg, Pennsylvania. Details concerning the matters to be addressed at the business meeting are contained in the Supplementary Information section of this notice.
March 6, 2014, at 8:30 a.m.
North Office Building, Hearing Room 1 (Ground Level), North Street (at Commonwealth Avenue), Harrisburg, Pa. 17120
Richard A. Cairo, General Counsel, telephone: (717) 238-0423, ext. 1306; fax: (717) 238-2436.
The business meeting will include actions or presentations on the following items: (1) Informational presentation on efforts to restore migratory fish passage on the lower Susquehanna River; (2) rulemaking action on revised emergency water use provisions; (3) memorandum of understanding with New York State facilitating coordinated regulatory activities; (4) revision of FY-2015 budget; (5) ratification/approval of contracts/grants; (6) ratification of settlement agreement pertaining to Federal Energy Regulatory Commission (FERC) licensing of York Haven Hydroelectric project, and authorization to execute on behalf of the Commission additional contemplated settlement agreements under FERC licensing procedures (7) Inflection Energy, LLC and Talisman Energy USA regulatory compliance matters; and (8) Regulatory Program projects. Projects listed for Commission action are those that were the subject of a public hearing conducted by the Commission on February 6, 2014, and identified in the notice for such hearing, which was published in 79 FR 2243, January 13, 2014.
Interested parties are invited to attend the business meeting and encouraged to review the Commission's Public Meeting Rules of Conduct, which are posted on the Commission's Web site,
Pub. L. 91-575, 84 Stat. 1509 et seq., 18 CFR Parts 806, 807, and 808.
The following Applications for Certificates of Public Convenience and Necessity and Foreign Air Carrier Permits were filed under Subpart B (formerly Subpart Q) of the Department of Transportation's Procedural Regulations (See 14 CFR 301.201 et. seq.). The due date for Answers, Conforming Applications, or Motions to Modify Scope are set forth below for each application. Following the Answer period DOT may process the application by expedited procedures. Such procedures may consist of the adoption of a show-cause order, a tentative order, or in appropriate cases a final order without further proceedings.
Description: Application of Eastern Air Lines Group, Inc. (Eastern) requesting a certificate of public convenience and necessity authorizing Eastern to engage in foreign charter air transportation of persons, property and mail.
Federal Railroad Administration (FRA), Department of Transportation (DOT).
Notice of Intent to Prepare an Environmental Impact Statement (EIS).
FRA issues this Notice of Intent (Notice) to advise the public that FRA and the Illinois Department of Transportation (IDOT) will jointly prepare a Tier 2 Environmental Impact Statement (EIS) for the Chicago to Joliet High-Speed Rail (HSR) Project (Project). The EIS will evaluate environmental and related impacts of upgrading the rail system and associated infrastructure between the Chicago, IL Union Station and the Joliet, IL Union Station to implement high-speed passenger rail service, increase rail capacity, and improve reliability for identified incremental service additions.
FRA issues this Notice to solicit public and agency input into the development of the scope of the EIS and to advise the public that outreach activities conducted by FRA and IDOT will be considered in the preparation of the EIS. To ensure all significant issues are identified and considered, the public, governmental agencies, and all other interested parties are invited to comment on the scope of the EIS, including the purpose and need, alternatives to be considered, impacts to be evaluated, and methodologies to be used in the evaluation.
Written comments on the scope of the EIS should be provided to IDOT within thirty (30) days of the publication of this Notice, at the address listed below. Comments may also be provided orally or in writing at the scoping meetings for the Project. Scoping meeting dates, times and locations, in addition to Project information can be found online on the FRA Web site at
• February 24, 2014: Chicago Union Station, The Union Gallery, 500 W. Jackson Boulevard, Chicago, IL 60661.
• February 26, 2014: Jacob Henry Mansion, Victorian Ballroom, 15 S. Richards Street, Joliet, IL 60433.
• February 27, 2014: Homewood Suites by Hilton Orland Park, 6245 S La Grange Road, Orland Park, IL 60467.
Written comments on the scope of the EIS should be mailed or emailed within thirty (30) days of the publication of this Notice to Mr. John Oimoen, Deputy Director, Department of Intermodal and Public Transit, Illinois Department of Transportation, 100 West Randolph Street, Suite 6-600, Chicago, Illinois 60601,
Ms. Andrea Martin, Environmental Protection Specialist, Office of Railroad Policy and Development, Federal Railroad Administration, 1200 New Jersey Avenue SE, (Mail Stop 20), Washington, DC 20590,
FRA is preparing an EIS for the Project proposed by IDOT that will provide HSR service along the Rock Island District (RID) Railroad corridor between Chicago and Joliet, IL. The proposed Project consists of additional track, geometric improvements (e.g., curves), bridge/culvert improvements, grade separations at selected highway-rail crossings, a rail-rail flyover, highway-rail grade crossing warning device improvements, safety improvements to existing Metra Stations to accommodate the HSR through traffic, and a new HSR station or improvements to an existing Metra Station to accommodate HSR service. Scenarios of HSR service will be developed and evaluated including additional frequencies (i.e., number of trips), ridership projections (i.e., estimated number of passengers), and operating speeds.
The Project is intended to implement a portion of the Chicago to St. Louis HSR Corridor Program consistent with the overall purpose and need that was established in the Tier 1 EIS. Because of inadequate rail capacity and deficiencies in the existing rail infrastructure, there is currently a modal imbalance within the Chicago to St. Louis corridor. Currently, 98 percent of the 51 million trips made annually within the Chicago to St. Louis corridor are accomplished through automobile, with only one percent by passenger rail. This modal imbalance contributes to high roadway congestion, reduced
The EIS will be developed in accordance with the Council on Environmental Quality (CEQ) regulations (40 CFR part 1500
The purpose of the Tier 2 EIS will be to provide the FRA, reviewing and cooperating agencies, and the public with information to assess alternatives that will meet the Project's purpose and need; to evaluate the potential environmental impacts of each alternative; and to identify potential measures necessary to mitigate or avoid environmental impacts associated with the proposed Project alternatives.
The FRA initiated the High-Speed Intercity Passenger Rail (HSIPR) Program in June 2009 as part of the American Recovery and Reinvestment Act (ARRA). On January 28, 2010, Illinois was selected for a $1.2 billion federal award to bring high-speed passenger rail service to Illinois between Dwight and the East St. Louis area. In addition, the Illinois Capital Bill appropriated $400 million for high-speed rail. In December 2010, an additional $42.3 million was received for construction upgrades. The City of Alton and Madison County also received a $13.9 million Transportation Investment Generating Economic Recovery (TIGER) Discretionary Grant for a transportation center in late 2011. And, in January 2012, $186.3 million was received for corridor improvements between Joliet and Dwight, IL. IDOT, local municipalities, and the UPRR have provided matching funds to this overall funding package.
In 2012, FRA completed a Final Program EIS for the Chicago to St. Louis HSR Corridor Program as the first phase of a tiered environmental review process, and issued a Record of Decision on the Final Program EIS on December 18, 2012. The Chicago to St. Louis HSR Corridor Program encompasses a corridor that is approximately 284 miles long with trains operating primarily on UPRR track with service provided by Amtrak. The improvements to the route will allow future passenger rail service from Chicago to St. Louis to operate at speeds up to 110 miles per hour (mph). The Tier 1 EIS established the purpose and need for the Chicago to St. Louis HSR Corridor Program, analyzed the Chicago to St. Louis HSR Corridor Program, and considered and evaluated alternatives including a no action alternative and multiple alternative alignments along existing rail corridors between Chicago and St. Louis. The Tier 1 EIS considered increasing the frequency of high-speed passenger rail service, as well as increasing the currently planned maximum speed of such service up to 110 miles per hour (mph), in the Corridor.
As part of the Tier 1 evaluation, FRA selected the Rock Island (RID) Corridor as the Preferred Alternative between Joliet and Chicago; the existing Amtrak route as the Preferred Alternative between Joliet and St. Louis; and a consolidated route along 10th Street through Springfield as the Preferred Alternative for the Springfield Rail Improvements Project. These proposed improvements were considered in addition to those improvements from Dwight to St. Louis associated with FRA's 2004 Record of Decision for the Chicago to St. Louis HSR Project and the 2011 Environmental Assessment (EA)/Finding of No Significant Impact (FONSI) for the UPRR's Track Improvement Project from Joliet to Dwight, IL.
As previously mentioned, FRA and IDOT will be responsible for implementing the Project and will jointly prepare a Tier 2 EIS. This Tier 2 EIS represents the next stage in the tiered environmental review process associated with the Chicago to St. Louis HSR Corridor Program. The Chicago to Joliet Tier 2 EIS will evaluate reasonable Build Alternatives that would be associated with the development and implementation of HSR service along the existing Rock Island Corridor (RID) Corridor in more detail, this component of the Selected Alternative carried forward from the Tier 1 study.
Tier 2 analyses are also being conducted for the Springfield flyover and Granite City to St. Louis segments. The Tier 2 evaluation for the Springfield Rail Improvements Project was conducted concurrently to the Tier 1 study. More information regarding the development, evaluation, and selection of alignments during the Tier 1 EIS process, the Chicago to St. Louis HSR Tier 1 Draft EIS, Final EIS, and ROD can be viewed at the following Web site:
In addition to the remaining Tier 2 Project components of the Chicago to St. Louis HSR Corridor Program that were identified in the Tier 1 ROD, there are four regional rail programs that relate to the Chicago to Joliet HSR Project being studied in this Tier 2 EIS: the Chicago Region Environmental and Transportation Efficiency Program (CREATE), Chicago-St. Louis 220 mph High-Speed Rail Express, Midwest Regional Rail Initiative (MWRRI), and Chicago-Detroit/Pontiac Passenger Rail Corridor Program.
CREATE is a cooperative effort between the U.S. Department of Transportation, the State of Illinois, the City of Chicago, the Metropolitan Rail Corporation (Metra), the National Railroad Passenger Corporation (Amtrak), and six freight railroads to improve freight and passenger rail efficiency and to reduce rail/highway traffic conflicts. There are five projects specifically identified by CREATE: P1 (63rd Street and State Street in Chicago); P2 (74th Street in Chicago), P3 (75th
The Chicago-St. Louis 220 mph High-Speed Rail Express is a concept being pursued by IDOT. This service, at speeds up to 220 mph, may utilize existing rail corridors, a new corridor, or a combination of both, and could serve different travel markets. The 220 mph concept is intended as a complementary service to the HSR service that was evaluated in the Chicago-St. Louis Tier 1 EIS. A feasibility study was prepared in 2009 by the Midwest High Speed Rail Association that indicated that a completely grade separated route could be established by modifying existing rail corridors to connect Chicago, Champaign, Decatur and Springfield, Illinois with St. Louis, Missouri, with a one-way terminal-to-terminal trip time of approximately two hours, utilizing a maximum speed of 220 mph. Also in 2009, an Expression of Interest was prepared by the French National Railways (SNCF) in response to the FRA's Request for Expression of Interest dated December 11, 2008. The SNCF proposed a HSR route to be located adjacent to existing rail corridors and sharing existing rail corridors in urban approaches at lower speeds. IDOT intends to further study the 220 mph project concept, including development of an investment-grade business plan. IDOT completed a preliminary feasibility study for the 220 mph project in September 2013.
MWRRI is an effort of nine Midwestern States to upgrade Amtrak service in those states, with maximum speeds of 79 to 110 mph depending on the level of improvements made. A Chicago-St. Louis corridor is included in MWRRI's September 2004 Executive Report and November 2006 Benefit Cost and Economic Analysis. Additional corridors proposed by MWRRI include: Chicago-Green Bay, Wisconsin; Chicago-Minneapolis, Minnesota; St. Louis-Kansas City, Missouri; Chicago-Cincinnati, Ohio; Chicago-Cleveland, Ohio; Chicago-Detroit, Michigan; Chicago-Port Huron, Michigan; Chicago-Carbondale, Illinois; Chicago-Quincy, Illinois; and Chicago-Omaha, Nebraska. Several other feeder corridors connecting smaller municipalities to the primary corridors are also included. More information is available at
As part of the Chicago-Detroit/Pontiac Passenger Rail Corridor Program, FRA and the Michigan Department of Transportation (MDOT) are jointly preparing a Tier 1 EIS to evaluate passenger rail service improvements along the Chicago, Illinois to Detroit-Pontiac, Michigan regional passenger rail corridor. Partnering state agencies in the development of the EIS are IDOT and Indiana Department of Transportation (INDOT). The objectives of the Tier 1 EIS are to evaluate a reasonable range of alternatives, select a rail corridor, and make decisions regarding future improvements to intercity passenger rail service provided in the corridor, including increased train frequency, reduced trip time, and improved on-time performance. Alternatives under consideration will include a No-build Alternative, as well as multiple build alternatives between Chicago, Illinois and Porter, Indiana, near Battle Creek, Michigan, and in the Detroit, Michigan region. The Build Alternatives may include infrastructure improvements to the existing rail corridor, the development of a new rail corridor, or a combination of both. More information is available at
Although related, the successful implementation of the Chicago to Joliet HSR Project is not dependent on the completion of the above four programs. As indicated above, however, the five CREATE projects may involve and affect high-speed rail service within the Project corridor. The P1 CREATE project is under construction. The other four are undergoing NEPA studies at this time. Where the three CREATE projects still under study are integrated into the Chicago to Joliet HSR Project alternatives, their impacts will be considered. Finally, the Chicago to Joliet HSR Project will not restrict consideration of alternatives for the above four projects.
FRA encourages broad participation in the Tier 2 EIS process during scoping and review of the resulting environmental documents. Comments are invited from all interested agencies and the public to ensure the full range of issues related to the Project are addressed, reasonable alternatives are considered, and significant issues are identified. In particular, FRA is interested in identifying areas of environmental concern where there might be a potential for significant impacts. Public agencies with jurisdiction are requested to advise FRA and IDOT of the applicable permit and environmental review requirements of each agency, and the scope and content of the environmental information that is germane to the agency's statutory responsibilities in connection with the proposed Project. Public agencies are requested to advise FRA if they anticipate taking a major action in connection with the proposed Project and if they wish to cooperate in the preparation of the EIS.
Public scoping opportunities and meetings will be scheduled as described above and are an important component of the scoping process for federal environmental review. FRA is seeking participation and input of all interested federal, state, and local agencies, Native American groups, and other concerned private organizations and individuals on the scope of the EIS. The Project may affect historic properties and may be subject to the requirements of Section 106 of the National Historic Preservation Act of 1966 (NHPA) (16 U.S.C. 470(f)). In accordance with regulations issued by the Advisory Council on Historic Preservation (36 CFR part 800), FRA intends to coordinate compliance with Section 106 of the NHPA with the preparation of the EIS, beginning with the identification of consulting parties through the scoping process, in a manner consistent with the standards set out in 36 CFR 800.8. FRA encourages broad participation in the Tier 2 EIS process during scoping and review of the resulting environmental documents. Comments are invited from the public, governmental agencies, and all other interested parties to ensure the full range of issues related to the Project are addressed, reasonable alternatives are considered, and significant issues are identified. In particular, FRA is interested in identifying areas of environmental concern where there might be a potential for significant impacts. Public agencies with jurisdiction are requested to advise FRA and IDOT of the applicable permit and environmental review requirements of each agency, and the scope and content of the environmental information that is germane to the agency's statutory responsibilities in connection with the proposed Project. Public agencies are requested to advise FRA if they anticipate taking a major action in connection with the proposed Project and if they wish to cooperate in the preparation of the EIS.
Public scoping opportunities and meetings will be scheduled as described above and are an important component of the scoping process for federal environmental review. FRA is seeking participation and input of all interested federal, state, and local agencies, Native American groups, and other concerned private organizations and individuals on the scope of the EIS. The proposed Project is a federal undertaking with the potential to affect historic properties. As such, it is subject to the requirements of Section 106 of the National Historic Preservation Act of 1966 (NHPA) (16 U.S.C. 470(f)). In accordance with regulations issued by the Advisory Council on Historic Preservation (36 CFR part 800), FRA intends to coordinate compliance with Section 106 of the NHPA with the preparation of the EIS, beginning with the identification of consulting parties through the scoping process, in a manner consistent with the standards set out in 36 CFR 800.8.
Federal Railroad Administration (FRA), Department of Transportation (DOT).
Notice of Intent to Prepare an Environmental Impact Statement (EIS).
FRA is issuing this Notice of Intent (Notice) to advise the public that FRA and the Illinois Department of Transportation (IDOT) will jointly prepare a Tier 2 Environmental Impact Statement (EIS) for the Granite City to St. Louis High-Speed Rail (HSR) Project (Project). The EIS will evaluate environmental and related impacts of upgrading rail system and infrastructure between Union Pacific Railroad (UPRR) Milepost (MP) 273 near Granite City, IL and the St. Louis Gateway Station in St. Louis, MO to implement high-speed passenger rail service, increase rail capacity, and improve reliability for identified incremental service additions.
FRA is issuing this Notice to solicit public and agency input into the development of the scope of the EIS and to advise the public that outreach activities conducted by FRA and IDOT will be considered in preparation of the EIS. To ensure all significant issues are identified and considered, the public, governmental agencies, and all other interested parties are invited to comment on the scope of the EIS, including the purpose and need, alternatives to be considered, impacts to be evaluated, and methodologies to be used in the evaluation.
Written comments on the scope of the EIS should be provided to IDOT within thirty (30) days of the publication of this notice, at the address listed below. The public scoping meeting is scheduled on February 25, 2014, as noted below. Scoping meeting date, time and location, in addition to Project information can be found online on the FRA Web site at
Written comments on the scope of the EIS may be mailed or emailed within thirty (30) days of the publication of this Notice to Mr. John Oimoen, Deputy Director of Railroads, Division of Public and Intermodal Transportation, Illinois Department of Transportation, 100 West Randolph Street, Suite 6-600, Chicago, Illinois 60601,
• The public scoping meeting will be advertised locally and is scheduled on February 25, 2014: Jackie Joyner-Kersee Center, 101 Jackie Joyner-Kersee Circle, East St Louis, IL 62204, from 5:00 p.m.-7:30 p.m.
Ms. Andréa E. Martin, Environmental Protection Specialist, Office of Railroad Policy and Development, Federal Railroad Administration, 1200 New Jersey Avenue SE., (Mail Stop 20), Washington, DC 20590,
FRA is preparing an EIS for the Project proposed by IDOT that will provide high-speed rail service between Granite City, IL and St. Louis, MO. The proposed Project would increase rail capacity associated with the Mississippi River crossings to accommodate increased rail traffic and improve reliability for identified incremental service additions anticipated with the proposed high-speed rail service of the Chicago to St. Louis HSR Corridor Program.
For the purposes of the Tier 2 EIS, a study area has been established that includes existing rail corridors. These corridors cover approximately five square miles between MP 273, near Granite City, IL and the St. Louis Gateway Station in St. Louis, MO, and include two 1,000-foot rail corridors (MacArthur Bridge and Merchants Bridge crossings) and two 500-foot intersecting roadway corridors (Niedringhaus and Bissell Avenues).
The Project is needed to accommodate the projected high-speed passenger rail traffic between MP 273, near Granite City, IL and the St. Louis Gateway Station in St. Louis, MO. Improved travel time, service reliability, and safety are necessary to attract travelers to high-speed passenger rail from automobile and air travel.
The Tier 2 EIS will analyze alternatives that meet the Project's purpose and need while maximizing community benefits and minimizing impacts to community, cultural, and natural resources. Anticipated improvements would require acquisition of new rights-of-way and permanent/temporary easements; however, the exact limits of the land acquisitions are not known at this time. Right-of-way impacts associated with proposed routes will be identified and made available for comment in the Draft EIS.
The inception of high-speed passenger rail service between Chicago and St. Louis, combined with increased freight traffic, would likely require the following:
• Improvements to existing bridges and other infrastructure
• Evaluation of the feasibility of a new station between Granite City and St. Louis
The EIS will evaluate the potential environmental and related impacts of constructing and operating the Project within the corridors located within Madison and St. Clair Counties, IL and St. Louis, MO.
The EIS will be developed in accordance with the Council on Environmental Quality (CEQ) regulations (40 CFR 1500
The purpose of the Tier 2 EIS will be to provide the FRA, reviewing and cooperating agencies, and the public with information to assess alternatives that will meet the Project's purpose and need; to evaluate the potential environmental impacts of each alternative; and to identify potential measures necessary to mitigate or avoid environmental impacts associated with the proposed Project alternatives.
FRA initiated the High-Speed Intercity Passenger Rail (HSIPR) Program in June 2009 as part of the American Recovery and Reinvestment Act (ARRA). On January 28, 2010, Illinois was selected for a $1.2 billion federal award to bring high-speed passenger rail service to Illinois between Dwight and the East St. Louis area. In addition, the Illinois Capital Bill appropriated $400 million for high-speed rail. In December 2010, an additional $42.3 million was received for construction upgrades. The City of Alton and Madison County also received a $13.9 million Transportation Investment Generating Economic Recovery (TIGER) Discretionary Grant for a transportation center in late 2011. And, in January 2012, $186.3 million was received for corridor improvements between Joliet and Dwight, IL. IDOT, local municipalities, and the UPRR have provided matching funds to this overall funding package.
In 2012, FRA completed a Final Program EIS for the Chicago to St. Louis High-Speed Rail Corridor Program as the first phase of a tiered environmental review process, and issued a Record of Decision on the Final Program EIS on December 18, 2012. The Chicago to St. Louis HSR Corridor Program encompasses a corridor that is approximately 284 miles long with trains operating primarily on UPRR track with service provided by Amtrak. The improvements to the route will allow future passenger rail service from Chicago to St. Louis to operate at speeds up to 110 miles per hour (mph). The Tier 1 EIS established the purpose and need for the Chicago to St. Louis HSR Corridor Program, analyzed the Chicago to St. Louis HSR Corridor Program, and considered and evaluated alternatives including a no action alternative and multiple alternative alignments along existing rail corridors between Chicago and St. Louis. The Tier 1 EIS considered increasing the frequency of high-speed passenger rail service, as well as increasing the currently planned maximum speed of such service up to 110 miles per hour (mph), in the Corridor.
As part of the Tier 1 evaluation, FRA selected the Rock Island Corridor as the Preferred Alternative between Joliet and Chicago; the existing Amtrak route as the Preferred Alternative between Joliet and St. Louis; and a consolidated route along 10th Street through Springfield as the Preferred Alternative for the Springfield Rail Improvements Project. These proposed improvements were considered in addition to those improvements from Dwight to St. Louis associated with FRA's 2004 Record of Decision for the Chicago to St. Louis HSR Project and the 2011 Environmental Assessment (EA)/Finding of No Significant Impact (FONSI) for the UPRR's Track Improvement Project from Joliet to Dwight, IL.
As previously mentioned, FRA and IDOT will be responsible for implementing the Project and will jointly prepare a Tier 2 EIS. This Tier 2 EIS represents the next stage in the tiered environmental review process associated with the Chicago to St. Louis HSR Corridor Program. The Tier 2 EIS for the Granite City to St. Louis HSR Project is part of the Chicago to St. Louis HSR Corridor Program and is being conducted to address and evaluate, in more detail, this component of the Selected Alternative carried forward from the Tier 1 study.
Tier 2 analyses are being conducted between Joliet and Chicago; for the Springfield flyover, and Granite City to St. Louis segments. The Tier 2 evaluation for the Springfield Rail Improvements Project was conducted concurrently to the Tier 1 study. More information regarding the development, evaluation, and selection of alignments during the Tier 1 EIS process, the Chicago to St. Louis HSR Tier 1 Draft EIS, Final EIS, and ROD can be viewed at the following Web site:
In addition to the remaining components of the Chicago to St. Louis HSR Corridor Program selected in the overall project's Tier 1 ROD, there are ongoing rail improvement programs that relate to the Project studied in this EIS, including the Chicago Region Environmental and Transportation Efficiency Program (CREATE), the Chicago to St. Louis 220 mph High-Speed Rail Express and the Midwest Regional Rail Initiative (MWRRI). Although related, the successful implementation of this Project is not dependent and will not restrict considerations of alternatives or the completion of the following regional rail improvement programs described below.
The Chicago to St. Louis 220 mph High-Speed Rail Express is a project concept being pursued by IDOT. This service, at speeds up to 220 mph, may utilize existing rail corridors, a new corridor, or a combination of both, and could serve different travel markets. The 220 mph concept is intended as a complementary service to the Chicago to St. Louis high-speed rail service that is being evaluated in this EIS. In 2009, the Midwest High-Speed Rail Association prepared a feasibility study that indicated that a completely grade separated route could be established by modifying existing rail corridors to connect Chicago, Champaign, Decatur and Springfield, IL with St. Louis, MO, with a one-way terminal-to-terminal trip time of approximately two hours, utilizing a maximum speed of 220 mph. The French National Railways (SNCF) prepared an Expression of Interest in 2009 in response to FRA's Request for Expression of Interest dated December 11, 2008. The SNCF proposed a high-speed rail route to be located adjacent to existing rail corridors and sharing existing rail corridors in urban approaches at lower speeds. IDOT intends to further study the 220 mph project concept, including development of an investment-grade business plan
MWRRI is an effort led by the Wisconsin Department of Transportation and supported by eight other midwestern states to upgrade Amtrak service in those states, with maximum speeds of 79 to 110 mph depending on the level of improvements made. A Chicago-St. Louis corridor is included in MWRRI's September 2004 Executive Report and November 2006 Benefit Cost and Economic Analysis. Additional corridors proposed by MWRRI include: Chicago-Green Bay, Wisconsin; Chicago-Minneapolis, Minnesota; St. Louis-Kansas City, Missouri; Chicago-Cincinnati, Ohio; Chicago-Cleveland, Ohio; Chicago-Detroit, Michigan; Chicago-Port Huron, Michigan; Chicago-Carbondale, Illinois; Chicago-Quincy, Illinois; and Chicago-Omaha, Nebraska. Several other feeder corridors connecting smaller municipalities to the primary corridors are also included. More information is available at
FRA encourages broad participation in the Tier 2 EIS process during scoping and review of the resulting environmental documents. Comments are invited from the public, governmental agencies, and all other interested parties to ensure the full range of issues related to the Project are addressed, reasonable alternatives are considered, and significant issues are identified. In particular, FRA is interested in identifying areas of environmental concern where there might be a potential for significant impacts. Public agencies with jurisdiction are requested to advise FRA and IDOT of the applicable permit and environmental review requirements of each agency, and the scope and content of the environmental information that is germane to the agency's statutory responsibilities in connection with the proposed Project. Public agencies are requested to advise FRA if they anticipate taking a major action in connection with the proposed Project and if they wish to cooperate in the preparation of the EIS.
Public scoping opportunities and meetings will be scheduled as described above and are an important component of the scoping process for federal environmental review. FRA is seeking participation and input of all interested federal, state, and local agencies, Native American groups, and other concerned private organizations and individuals on the scope of the EIS. The proposed Project is a federal undertaking with the potential to affect historic properties. As such, it is subject to the requirements of Section 106 of the National Historic Preservation Act of 1966 (NHPA) (16 U.S.C. 470(f)). In accordance with regulations issued by the Advisory Council on Historic Preservation (36 CFR 800), FRA intends to coordinate compliance with Section 106 of the NHPA with the preparation of the EIS, beginning with the identification of consulting parties through the scoping process, in a manner consistent with the standards set out in 36 CFR 800.8.
In accordance with Part 211 of Title 49 Code of Federal Regulations (CFR), this provides the public notice that by a document dated December 13, 2013, the Strasburg Rail Road Company (SRC) has petitioned the Federal Railroad Administration (FRA) for a waiver of compliance from certain provisions of the Federal railroad safety regulations. Specifically, SRC requests relief from certain provisions of 49 CFR Part 240, Qualification and Certification of Locomotive Engineers, and 49 CFR Part 242, Qualification and Certification of Conductors. The request was assigned Docket Number FRA-2014-0003. The relief is contingent on SRC's implementation of and participation in the Confidential Close Call Reporting System (C3RS).
SRC seeks to shield reporting employees and the railroad from mandatory punitive sanctions that would otherwise arise as provided in 49 CFR 240.117(e)(1)-(4); 240.305(a)(l)-(4) and (a)(6); 240.307; and 242.403(b), (c), (e)(l)-(4), (e)(6)-(11), and (f)(l)-(2). This will encourage certified operating crew members to report close calls and protect the employees and the railroad from discipline or sanctions arising from the incidents reported per the C3RS Implementing Memorandum of Understanding.
A copy of the petition, as well as any written communications concerning the petition, is available for review online at
All communications concerning these proceedings should identify the appropriate docket number and may be submitted by any of the following methods:
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Communications received within April 4, 2014 of the date of this notice will be considered by FRA before final action is taken. Comments received after that date will be considered as far as practicable.
Anyone is able to search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the comment (or signing the document, if submitted on behalf of an association, business, labor union, etc.). See
In accordance with Part 211 of Title 49 Code of Federal Regulations (CFR), this document provides the public notice that by a document dated November 19, 2013, Mr. Benny McCune of Cass Scenic Railroad State Park (CASS) of the West Virginia Division of Natural Resources has petitioned the Federal Railroad Administration (FRA) for a waiver of compliance from certain provisions of the Federal railroad safety regulations contained at 49 CFR Part 215, Railroad Freight Car Safety Standards. FRA assigned the petition Docket Number FRA-2013-0123.
Specifically, CASS seeks an exemption from the requirements for stenciling of restricted cars for three cabooses, identified as Car Numbers 50, 51, and 311. The three cabooses are more than 50 years of age and, therefore, are restricted in accordance with 49 CFR 215.203(a). Specifically, 215.303,
In support of its petition, CASS states that due to the historical importance of these cabooses and the fact that CASS is based on the historical facts surrounding the log camps of the early 1900s, CASS would like to keep the cabooses as historically accurate as possible.
CASS is a steam-powered tourist railroad operating on a main track of approximately 11 miles. There are additional sidings and a track connecting CASS with another State-owned and operated railroad, the West Virginia Central Railroad. The total track mileage is approximately 18 miles. CASS has been operating since June 1963.
CASS states that it operates from Memorial Day weekend through the end of October. CASS does not interchange passenger cars or passengers. One trip is a 1.5-hour round trip covering a total of 8 track miles. The other trip is a 4.5-hour round trip covering a total of 22 track miles. The trains travel at a speed of 6 to 8 mph.
CASS also states that these three cabooses are primarily used for overnight rentals and will be used for special charter trains for photographic purposes from one to five times per year. Apart from these photographic trips, the cabooses will only be moved for maintenance reasons, and at no time will they exceed a speed of 10 mph or carry any passengers.
CASS further states that these cabooses are well maintained and in good condition. The slow speed, short-trip length, and the fact that CASS will not be carrying any passengers on these cabooses make the cabooses safe to be operated in the limited capacity on CASS track.
In addition, CASS also requests a Special Approval to continue these cars in service in accordance with 49 CFR 205.203(c).
A copy of the petition, as well as any written communications concerning the petition, is available for review online at
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested party desires an opportunity for oral comment, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.
All communications concerning these proceedings should identify the appropriate docket number and may be submitted by any of the following methods:
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Communications received by April 4, 2014 will be considered by FRA before final action is taken. Comments received after that date will be considered as far as practicable.
Anyone is able to search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the comment (or signing the document, if submitted on behalf of an association, business, labor union, etc.). See
Federal Transit Administration, DOT.
Notice of proposed Buy America waiver and request for comment.
The City of Cincinnati (Cincinnati) has requested a Buy America waiver based upon non-availability for a cross-connect cabinet. The cross-connect cabinet is needed for Cincinnati Bell's utility relocation work associated with the Cincinnati Streetcar Project. This notice is to inform the public of the waiver request and to seek public comment to inform the Federal Transit Administration's (FTA) decision whether to grant the request.
Comments must be received by March 4, 2014. Late-filed comments will be considered to the extent practicable.
Please submit your comments by one of the following means, identifying your submissions by docket number FTA-2014-0002:
1.
2.
3.
4.
Mary J. Lee, FTA Attorney-Advisor, at (202) 366-0985 or
The purpose of this notice is to provide notice and to seek comment on whether FTA should grant a non-availability waiver for the procurement of a cross-connect cabinet that will be used in a utility relocation performed by Cincinnati Bell. This utility relocation will be performed in connection with the Cincinnati Streetcar Project, which is an FTA-funded project.
With certain exceptions, FTA's Buy America requirements prevent FTA from obligating an amount that may be appropriated to carry out its program for a project unless “the steel, iron, and manufactured goods used in the project are produced in the United States.” 49 U.S.C. 5323(j)(1). A manufactured product is considered produced in the United States if: (1) all of the manufacturing processes for the product take place in the United States; and (2) all of the components of the product are of U.S. origin. A component is considered of U.S. origin if it is manufactured in the United States, regardless of the origin of its subcomponents. 49 CFR 661.5(d). If, however, FTA determines that “the steel, iron, and goods produced in the United States are not produced in a sufficient and reasonably available amount or are not of a satisfactory quality,” then FTA may issue a waiver (non-availability waiver). 49 U.S.C. 5323(j)(2)(B); 49 CFR 661.7(c).
On September 30, 2013, the City of Cincinnati (Cincinnati) formally requested a non-availability waiver for the procurement of one cross-connect cabinet.
On October 17, 2013, Cincinnati alerted FTA that Cincinnati Bell had installed the cross-connect cabinet in order to comply with its scheduling demands. Unfortunately, because almost all FTA employees were furloughed during this time due to a partial government shutdown, Cincinnati was unable to consult with FTA on how to proceed.
The purpose of this notice is to publish the request and seek public comment from all interested parties in accordance with 49 U.S.C. 5323(j)(3)(A). Comments will help FTA understand completely the facts surrounding the request, including the effects of a potential waiver and the merits of the request. If granted, the waiver would apply to one procurement and FTA would expect that Cincinnati Bell work towards finding a domestically manufactured cross-connect cabinet that meets its network specifications for future FTA-funded projects. A full copy of the request has been placed in docket number FTA-2014-0002.
Federal Transit Administration, DOT.
Notice of proposed Buy America waiver and request for comment.
The Federal Transit Administration (FTA) received a request for a waiver to permit the purchase of a Variable Refrigerant Flow (VRF) HVAC system that is non-compliant with Buy America requirements using FTA funding. The request is from the Rock Island County Metropolitan Mass Transit District (MetroLINK) for its Rock Island Transfer Station. In accordance with 49 U.S.C. 5323(j)(3)(A), FTA is providing notice of the waiver request and seeks public comment before deciding whether to grant the request. If granted, the waiver would apply only to the FTA-funded procurement of a VRF HVAC system by MetroLINK.
Comments must be received by March 4, 2014. Late-filed comments will be considered to the extent practicable.
Please submit your comments by one of the following means, identifying your submissions by docket number FTA-2013-0034:
1.
2.
3.
4.
Mary J. Lee, FTA Attorney-Advisor, at (202) 366-0985 or
The purpose of this notice is to provide notice and seek comment on whether the Federal Transit Administration (FTA) should a grant non-availability waiver for the Rock Island County Metropolitan Mass Transit District's (MetroLINK) procurement of a Variable Refrigerant Flow (VRF) HVAC system
With certain exceptions, FTA's Buy America requirements prevent FTA from obligating an amount that may be appropriated to carry out its program for a project unless “the steel, iron, and manufactured goods used in the project are produced in the United States.” 49 U.S.C. 5323(j)(1). A manufactured product is considered produced in the United States if: (1) All of the manufacturing processes for the product must take place in the United States; and (2) All of the components of the product must be of U.S. origin. A component is considered of U.S. origin if it is manufactured in the United States, regardless of the origin of its subcomponents. 49 CFR 661.5(d). If, however, FTA determines that “the steel, iron, and goods produced in the United States are not produced in a sufficient and reasonably available amount or are not of a satisfactory quality,” then FTA may issue a waiver (non-availability waiver). 49 U.S.C. 5323(j)(2)(B); 49 CFR 661.7(c).
MetroLINK is requesting a non-availability waiver for its procurement of a VRF HVAC system that will be installed into its passenger transfer facility in Rock Island, Illinois, the Rock Island Transfer Station. This facility is being built to U.S. Green Building Council (USGBC) Leadership in Energy and Environmental Design (LEED) standards and will incorporate a number of sustainable and energy efficient elements. One of those elements is a VRF HVAC system that, among other things, is space saving, has invertor technology, efficiency, and a non-ozone depleting refrigerant that domestic manufacturers of HVAC systems do not provide. According to MetroLINK, this VRF HVAC system is critical in obtaining the LEED points necessary to achieve the Silver certification (or better) that it is seeking. Thus, MetroLINK specified the brands Daikin AC and Mitsubishi or approved equal, but MetroLINK has been unable to identify a domestic manufacturer of the VRF HVAC system that meets its specifications and now requests that FTA grant a Buy America waiver.
A similar Buy America non-availability waiver was issued on June 22, 2010 by the U.S. Department of Energy (DOE) for the same VRF HVAC system. 75 FR 35447. According to MetroLINK, the U.S. DOE's determination of inapplicability (U.S. DOE's Buy America waiver for non-availability) of the American Reinvestment and Recovery Act of 2009 to the same VRF HVAC system indicates the continued non-availability of this product.
The purpose of this notice is to publish NFRMPO request and seek public comment from all interested parties in accordance with 49 U.S.C. 5323(j)(3)(A). Comments will help FTA understand completely the facts surrounding the request, including the effects of a potential waiver and the merits of the request. A full copy of the request has been placed in docket number FTA-2013-0034.
Surface Transportation Board.
Notice of Pooling Application and Request for Public Comments.
On January 16, 2014, TTX Company (TTX) and certain participating railroads (collectively Applicants) filed an application to extend for 15 years TTX's flatcar pooling authority, which the Board's predecessor, the Interstate Commerce Commission (ICC), originally granted in 1974 and extended in 1989 and 1994, and the Board again extended in 2004. Under the Board's 2004 order, TTX's pooling authority is set to expire October 1, 2014. If the application seeking renewal or modification of pooling authority is pending before the Board but not yet decided by the existing expiration date, the pooling authority shall continue until 180 days after the Board has issued a final decision on the request and all appeals of that decision have been exhausted or the time to appeal has expired.
Any comments on the application must be filed by April 21, 2014. If comments are filed, Applicants' rebuttal is due by May 19, 2014.
An original and 10 copies of all pleadings, referring to Docket No. FD 27590 (Sub-No. 4), must be filed with the Surface Transportation Board, 395 E Street SW., Washington, DC 20423-0001. In addition, one copy of each comment must be sent to each of Applicants' representatives: (1) Michael L. Rosenthal, Covington & Burling, 1201 Pennsylvania Avenue NW., Washington, DC 20004; (2) David L. Meyer, Morrison Foerster, 2000 Pennsylvania Avenue NW., Suite 6000, Washington, DC 20006; and (3) Patrick B. Loftus, TTX Company, 101 North Wacker Drive, Chicago, IL 60606.
Jonathon Binet, (202) 245-0368. Federal Information Relay Service (FIRS) for the hearing impaired: 1-800-877-8339.
Applicants seek the Board's approval of a 15-year extension of their pooling of flatcar service. Under 49 U.S.C. 11322(a), the Board may approve a pooling agreement if it finds that the proposal: (1) Will be in the interest of better service to the public or of economy of operation, and (2) will not unreasonably restrain competition. The proposed pooling agreement was originally approved by the ICC in
In addition to TTX, Applicants are:
Applicants contend that, because the proposed transaction does not involve any changes in rail operations or service to shippers, neither environmental documentation nor an historic report is required.
Filings and Board decisions and notices are available on the Board's Web site at “
This action will not significantly affect either the quality of the human environment or the conservation of energy resources.
By the Board, Rachel D. Campbell, Director, Office of Proceedings.
Surface Transportation Board.
Request for public comments.
On December 13, 2013, Rail-Term Corp. (Rail-Term) filed a petition for reconsideration of the Board's November 19, 2013 decision which found Rail-Term to be a “rail carrier,” as defined in the Interstate Commerce Act at 49 U.S.C. 10102(5), and, therefore, subject to the Board's jurisdiction. In response to filings by the Association of American Railroads (AAR), the American Short Line and Regional Railroad Association (ASLRRA), and the National Railroad Construction and Maintenance Association, Inc. (NRC), the Board is allowing the public to file comments as
Comments in support of reconsideration are due by March 10, 2014. Replies in opposition to reconsideration are due by March 31, 2014.
Comments and replies may be submitted either via the Board's e-filing format or in the traditional paper format. Any person using e-filing should attach a document and otherwise comply with the instructions at the E-FILING link on the Board's Web site, at
Jonathon Binet, (202) 245-0368. Assistance for the hearing impaired is available through the Federal Information Relay Service (FIRS) at (800) 877-8339.
Additional information is contained in the Board's decision. Board decisions and notices are available on our Web site at
By the Board, Rachel D. Campbell, Director, Office of Proceedings.
Bureau of the Fiscal Service, Fiscal Service, Department of the Treasury.
Notice.
This is Supplement No. 3 to the Treasury Department Circular 570, 2013 Revision, published July 1, 2013, at 78 FR 39440.
Surety Bond Branch at (202) 874-6850.
Notice is hereby given that the Certificate of Authority issued by the Treasury to Kansas Bankers Surety Company (NAIC# 15962) under 31 U.S.C. 9305 to qualify as an acceptable surety on Federal bonds is terminated immediately. Federal bond-approving officials should annotate their reference copies of the Treasury Department Circular 570 (“Circular”), 2013, Revision, to reflect this change.
With respect to any bonds currently in force with this company, bond-approving officers may let such bonds run to expiration and need not secure new bonds. However, no new bonds should be accepted from this company and bonds that are continuous in nature should not be renewed.
The Circular may be viewed and downloaded through the Internet at
Questions concerning this notice may be directed to the U.S. Department of the Treasury, Bureau of the Fiscal Service, Surety Bond Branch, 3700 East-West Highway, Room 6F01, Hyattsville, MD 20782.
Environmental Protection Agency (EPA).
Proposed rule.
This proposed Federal Implementation Plan (FIP) addresses the requirements of the Regional Haze Rule (RHR) and interstate visibility transport for the disapproved portions of Arizona's Regional Haze (RH) State Implementation Plan (SIP) as described in our final rule published on July 30, 2013. Our final rule on Arizona's RH SIP partially approved and partially disapproved the State's plan to implement the regional haze program for the first planning period. Today's proposed rule addresses the RHR's requirements for Best Available Retrofit Technology (BART), Reasonable Progress Goals (RPGs) and Long-term Strategy (LTS) as well as the interstate visibility transport requirements for pollutants that affect visibility in Arizona's 12 Class I areas as well as areas in nearby states. The BART sources addressed in this proposed FIP are Tucson Electric Power (TEP) Sundt Generating Station Unit 4, Lhoist Nelson Lime Plant Kilns 1 and 2, ASARCO Incorporated Hayden Smelter, and Freeport-McMoran Inc. (FMMI) Miami Smelter. The sources with proposed controls for reasonable progress are the Phoenix Cement Clarkdale Plant and the CalPortland Cement Rillito Plant.
Written comments must be submitted to the designated contact at the address in the General Information section of
See the General Information section of
Thomas Webb, U.S. EPA, Region 9, Planning Office, Air Division, Air, 75 Hawthorne Street, San Francisco, CA 94105. Thomas Webb may be reached at telephone number (415) 947-4139 and via electronic mail at
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This proposed action relies on documents, information and data that are listed in the index on
Written comments must be submitted on or before March 31, 2014. Submit your comments, identified by Docket ID No. EPA-R09-OAR-2013-0588, by one of the following methods:
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EPA's policy is to include all comments received in the public docket without change.
Do not submit CBI to EPA through
When submitting comments, remember to:
• Identify the rulemaking by docket number and other identifying information (e.g., subject heading,
• Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
• Describe any assumptions and provide any technical information and/or data that you used.
• If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
• Provide specific examples to illustrate your concerns, and suggest alternatives.
• Explain your views as clearly as possible, avoiding profanity or personal threats.
• Make sure to submit your comments by the identified comment period deadline.
To provide opportunities for questions and discussion, EPA will hold an open house prior to the public hearing. During the open house, EPA staff will be available informally to
EPA will hold two public hearings at the dates, times and locations stated below to accept oral and written comments into the record. To request interpretation services or to request reasonable accommodation for a disability, please contact the person in the
Public Hearing in Phoenix:
Public Hearing in Tucson:
The public hearing will provide the public with an opportunity to present views or information concerning the proposed RH FIP for Arizona. EPA may ask clarifying questions during the oral presentations, but will not respond to the presentations at that time. We will consider written statements and supporting information submitted during the comment period with the same weight as any oral comments and supporting information presented at the public hearing. Please consult section I.C, I.D and I.E of this preamble for guidance on how to submit written comments to EPA. We will include verbatim transcripts of the hearing in the docket for this action. The EPA Region 9 Web site for the rulemaking, which includes the proposal and information about the public hearing, is at
The Clean Air Act (CAA) establishes as a national goal the prevention of any future, and the remedying of any existing man-made impairment of visibility in 156 national parks and wilderness areas designated as Class I areas. Arizona has a wealth of such areas. The sources addressed in this FIP affect many Class I areas in the State of Arizona and adjacent states. This FIP will ensure that progress is made toward natural visibility conditions at these national treasures, as Congress intended when it directed EPA to improve visibility in national parks and wilderness areas. Please refer to our previous rulemaking on the Arizona RH SIP for additional background regarding the CAA, regional haze and EPA's RHR.
We propose to promulgate a FIP as described in this notice and summarized in this section to address those portions of Arizona's RH SIP that we disapproved on July 30, 2013.
EPA conducted BART analyses and determinations for four sources: Sundt Generating Station Unit 4, Nelson Lime Plant Kilns 1 and 2, Hayden Smelter and Miami Smelter. The results of our BART evaluations are summarized here for each source and are shown in Table 1. We are seeking comments on our proposals.
EPA proposes to find that provisions in today's proposal in combination with provisions in the approved Arizona SIP and FIP
We propose that a combination of SIP and FIP measures will satisfy the FIP obligation for the visibility requirement of CAA section 110(a)(2)(D)(i)(II) for the 1997 8-hour ozone, 1997 PM
EPA received a notice of intent to sue in January 2011 stating that we had not met the statutory deadline for promulgating RH FIPs and/or approving RH SIPs for dozens of states, including Arizona. This notice was followed by a lawsuit filed by several advocacy groups (Plaintiffs) in August 2011.
Because four of Arizona's 12 mandatory Class I Federal areas are on the Colorado Plateau, the State had the option of submitting a RH SIP under CAA section 309 of the RHR. A SIP that is approved by EPA as meeting all of the requirements of section 309 is “deemed to comply with the requirements for reasonable progress with respect to the 16 Class I areas [on the Colorado
In response to a court decision,
EPA made a finding on January 15, 2009, that 37 states, including Arizona, had failed to make all or part of the required SIP submissions to address regional haze.
ADEQ adopted and transmitted its 2011 RH SIP under section 308 of the RHR to EPA Region 9 in a letter dated February 28, 2011. The SIP was determined complete by operation of law on August 28, 2011.
As shown in Table 3, the first phase of EPA's action on the 2011 RH SIP addressed three BART sources. The final rule for the first phase (a partial approval and partial disapproval of the State's plan and a partial FIP) was signed by the Administrator on November 15, 2012, and published in the
Under CAA section 110(c), EPA is required to promulgate a FIP within 2 years of the effective date of a finding that a state has failed to make a required SIP submission. The FIP requirement is terminated if a state submits a regional haze SIP, and EPA approves that SIP before promulgating a FIP. See 74 FR 2392. Specifically, CAA section 110(c) provides:
(1) The Administrator shall promulgate a Federal implementation plan at any time within 2 years after the Administrator—
(A) finds that a State has failed to make a required submission or finds that the plan or plan revision submitted by the State does not satisfy the minimum criteria established under [CAA section 110(k)(1)(A)], or
(B) disapproves a State implementation plan submission in whole or in part, unless the State corrects the deficiency, and the Administrator approves the plan or plan revision, before the Administrator promulgates such Federal implementation plan.
[A] plan (or portion thereof) promulgated by the Administrator to fill all or a portion of a gap or otherwise correct all or a portion of an inadequacy in a State implementation plan, and which includes enforceable emission limitations or other control measures, means or techniques (including economic incentives, such as marketable permits or auctions or emissions allowances) . . .
The purpose of the BART analysis is to identify and evaluate the best system of continuous emission reduction based on the BART Guidelines
Step 1—Identify all available retrofit control technologies.
Step 2—Eliminate technically infeasible options.
Step 3—Evaluate control effectiveness of remaining control technologies.
Step 4—Evaluate impacts and document the results.
• Factor 1: Cost of compliance.
• Factor 2: Energy and non-air quality environmental impacts of compliance.
• Factor 3: Pollution control equipment in use at the source.
• Factor 4: Remaining useful life of the facility.
• Factor 5: Visibility impacts.
Step 5—Select BART.
EPA estimated the degree of visibility improvement expected to result from various BART control options based on the difference between baseline visibility impacts prior to controls and visibility impacts with controls in operation. Baseline emissions were based on the highest 24-hour emissions from monitored emissions data when available, otherwise from estimates of production rates and emission factors. Control case emissions were derived from the baseline by applying the percent reduction in emission factor expected from the control. Impacts at all Class I areas within 300 km of each facility were assessed. EPA used the CALPUFF model version 5.8
EPA modeled all units (stacks) and pollutants simultaneously for each source. Modeling of all emissions from all units accounts for the chemical interaction between multiple plumes, and between plumes and background concentrations. This also accounts for the fact that deciview benefits from controls on individual units are not strictly additive. As recommended in the BART Guidelines, the 98th percentile daily impact in deciviews is used as the basic metric of visibility impact. EPA relied on the 98th percentile over the merged 2001-2003 period. The alternative of using the average of the three 98th percentiles from 2001, 2002 and 2003 was also calculated, and the results of using it are provided in the TSD, although they differ little from the merged approach. Both are valid indicators of the 98th percentile.
For each facility, this notice provides one or more tables of visibility impacts and visibility improvement from controls in deciviews. Each table has the same format: columns list the Class I areas within 300 km of the facility, the distance,
(1) “Cumulative (sum),” the cumulative impact or improvement that is computed as the sum of impact or improvement over all the areas;
(2) “Maximum,” single largest impact or improvement that is the maximum over all the areas;
(3) “# CIAs >= 0.5 dv,” the number of Class I areas having a baseline impact from the source of at least 0.5 dv (or, for the control columns, the number of areas showing improvement of at least 0.5 dv due to the control);
(4) “Million $/dv (cumul. dv),” annual control cost in millions of dollars per deciview considering the improvement at all the Class I areas together; and
(5) “Million $/dv (max. dv),” annualized cost per deciview considering the largest single area improvement.
The Federal Land Managers have sometimes used $10 million/dv as a comparison benchmark for the $/dv computed from the maximum, and $20 million/dv as a benchmark for $/dv computed from cumulative deciviews. We have not endorsed the use of these or any other $/dv benchmarks as criteria for making BART determinations.
The TSD for this notice provides bar charts and additional visibility tables, including results for individual modeled years and their average, the old IMPROVE equation, and annual average background conditions instead of best 20 percent. There also are model results for various sensitivity analyses.
TEP has
Saguaro NP has an eastern unit, the Rincon Mountain District, and a western unit, the Tucson Mountain District. In the original set of modeling receptor locations developed by the National Park Service, only the eastern unit was included. CALPUFF modeling typically covered only the eastern unit. This is true of modeling by the WRAP, and also of modeling by EPA's contractor UNC, which used the WRAP work as a starting point. A more recent set of NPS modeling receptors from 2008 is available that covers both eastern and western units of Saguaro. For this FIP, EPA remodeled for both Saguaro units where needed for a given facility. The only facilities for which it makes a significant difference are TEP Sundt and CalPortland Cement due to their close proximity to Saguaro.
EPA is proposing to find that Sundt Unit 4 is eligible for and subject to BART. In our final rulemaking on the Arizona RH SIP dated July 30, 2013, we disapproved ADEQ's finding that Sundt Unit 4 was not eligible for BART.
Under the RHR and the BART Guidelines, any BART-eligible source that either “causes” or “contributes” to visibility impairment at any Class I area is subject to BART.
For our NO
EPA proposes to find that SNCR and selective catalytic reduction (SCR) are available and technically feasible options to control NO
SNCR involves the non-catalytic decomposition of NO
SCR is a post-combustion gas treatment technique that uses either ammonia or urea in the presence of a metal-based catalyst to selectively reduce NO
Existing vendor literature and technical studies indicate that SCR systems are capable of achieving approximately 80 to 90 percent control efficiency, and that this emission rate can be achieved on a retrofit basis, particularly when combined with combustion control technology such as LNB.
Our consideration of the cost of compliance focuses primarily on the cost-effectiveness of each control option as measured in average cost per ton and incremental cost per ton of each control option as shown in Table 8. SCR is the most stringent option with the highest average cost-effectiveness of $5,176/ton, and incremental cost-effectiveness over SNCR of $6,174/ton. Detailed cost calculations can be found in our docket.
• We have changed the unit size from 173 MW to 130 MW to reflect the gross capacity of using coal. Although this has the net effect of decreasing certain costs, particularly several operation and maintenance (O&M) costs, the revised capital cost estimates increased for SCR (from $38 million to $45 million) and SNCR (from $2.8 million to $3.1 million).
• We have used a retrofit difficulty value of 1.5 (increased from 1.0) in cost estimates due to certain difficulties associated with retrofit installation of SCR. These difficulties are the result of site congestion and the configuration of the existing boiler structure and coal handling system as noted by TEP.
• We have included the cost of air preheater modifications that TEP stated are necessary in order to accommodate SCR due to site congestion and coal handling configuration.
EPA proposes to find that BART for NO
In proposing an emission limit of 0.36 lb/MMBtu, we have considered the annual average design value for SNCR of 0.31 lb/MMBtu as well as the need to account for emissions associated with startup and shutdown events. To account for this variability, we have examined the difference between the highest 30-day rolling NO
We propose to require compliance with this requirement within three years of the effective date of the final rule. A 2006 Institute of Clean Air Companies (ICAC) study indicated that the installation time for a typical SNCR retrofit, from bid to startup, is 10 to 13 months.
For our SO
EPA identified three available and technically feasible technologies to control SO
Design concerns associated with wet FGD involve the substantial water usage requirements needed to generate the alkaline reagent slurry as well as the substantial amount of wastewater and solid waste discharge associated with the spent byproduct. A wet FGD control system must be located after the fabric filter baghouse because the moist plume resulting from the wet scrubber system would create baghouse plugging issues if the control is placed ahead of the baghouse. In addition, a substantial footprint is required for the management of these waste products as well as for the absorber tower and associated process equipment such as the slurry preparation, mixing, associated tanks, and dewatering activities. While these design concerns do present some challenges, they do not warrant elimination of this option as technically infeasible.
Our contractor has estimated that newly constructed wet FGD systems could achieve design emission rates (annual average basis) of 0.06 lb/MMBtu. Relative to baseline SO
A design concern associated with a dry FGD system is that it must be installed prior to the fabric filter baghouse in order for the reagent to be captured and recycled. As noted in our contractor's report, the location of the existing fabric filter baghouse does not present enough space to install a new absorber between the boiler and the existing baghouse. As a result, a dry FGD at Sundt Unit 4 is assumed to include a new baghouse, which is reflected in the costs of compliance for the five-factor analysis. We consider this control option to be technically feasible.
Our contractor has estimated that newly constructed dry FGD systems could achieve design emission rate (annual average basis) of 0.08 lb/MMBtu. Relative to baseline SO
In a review of SO
In evaluating the costs of compliance for the control options, we have calculated the control costs ($) and emission reductions (tons/year of pollutant) for each control technology, developed average cost-effectiveness ($/ton) values, and arrived at the emission reductions for each option as summarized Table 12. A more detailed version of emission calculations is in our docket,
For dry FGD, the energy and non-air environmental impacts are similar to those for wet FGD. Operation of a dry FGD system still requires securing significant supplies of water, although to a lesser degree than wet FGD systems. In addition, dry FGD systems will result in generation of larger quantities of boiler ash, and has the potential to affect negatively the properties and quality of boiler ash. In some instances, boiler ash that is suitable to sell for beneficial purposes may no longer be marketable following installation of a dry FGD system. Energy impacts also include auxiliary power requirements for operation of the dry FGD system, and for overcoming pressure head loss through the scrubber. While we note certain potential impacts resulting from the water resource requirements associated with wet FGD as well as the additional solid waste generation associated with wet and dry FGD, we do not consider these impacts sufficient enough to warrant eliminating these control technologies.
DSI could potentially have an adverse effect on the quality of the boiler fly ash, which would make it unmarketable for beneficial uses. Use of DSI also results in an ash byproduct which would require landfill disposal, thereby increasing solid waste generation rates at the plant. Energy impacts are limited to auxiliary power requirements for operation of the DSI system. We do not consider these impacts sufficient enough to warrant eliminating this control technology.
EPA proposes an emission limit of 0.23 lb/MMBtu on a 30-day (BOD) rolling basis as BART to control SO
We propose to require compliance with this requirement within three years of the effective date of the final rule. However, we are seeking comment on whether this compliance date is reasonable and consistent with the requirement of the Clean Air Act that BART be installed “as expeditiously as practicable but in no event later than five years after [promulgation of the applicable FIP].”
Sundt Unit 4 currently operates with a fabric filter baghouse for particulate control, which is considered the most stringent control device for particulate matter. These devices operate on the same principle as a vacuum cleaner. Air carrying dust particles is forced through a cloth bag that is designed and manufactured to trap particles greater than a certain specified diameter. As the air passes through the fabric, the dust accumulates on the cloth and is removed from the air stream. The accumulated dust is periodically removed from the cloth by shaking or by reversing the air flow. The layer of dust, known as dust cake, trapped on the surface of the fabric has the potential to result in high efficiency rates for particles ranging in size from submicron to several hundred microns in diameter.
The BART Guidelines provide that, where a source has controls already in place that are the most stringent controls available, it is not necessary to complete comprehensively a full five-factor BART analysis, as long the most stringent controls available are made federally enforceable. Therefore, instead of completing the remaining steps of a five-factor BART analysis, we have evaluated the appropriate level of emissions to ensure that the fabric filter achieves an appropriate degree of control.
EPA is proposing a filterable PM
We are proposing a switch to natural gas on Sundt Unit 4 as a better-than-BART alternative to the emissions controls previously proposed in this section for a coal-fired unit. Unit 4 was originally constructed as a natural gas-fired boiler, and has used natural gas as a primary fuel for significant periods of time since 2009. While a change in fuel supply to natural gas instead of coal is an inherently less polluting option, the BART Guidelines do not require the consideration of fuel supply changes as a control option.
EPA has evaluated this alternative proposal pursuant to the “better-than-BART” provisions of the RHR. In particular, the RHR allows for implementation of “an emissions trading program or other alternative measure” in lieu of BART if the alternative measure achieves greater reasonable progress than would be achieved through the installation and operation of BART.
As seen in Table 16, a change to natural gas usage achieves greater emission reductions than each of the individual BART determinations for NO
Since Sundt is only 17 km from the eastern unit of Saguaro, its emitted NO
Based on this information, we consider a natural gas fuel switch to result in greater emission reductions and achieve greater reasonable progress than the proposed BART determinations. Under this scenario, we are proposing a NO
We primarily relied on four sources of information for our proposed BART analyses and determinations. An initial BART analysis performed by our contractor
As part of our July 30, 2013 final rulemaking on the Arizona RH SIP, we approved ADEQ's finding that Chemical Lime Nelson Plant (Nelson Lime Plant) Kilns 1 and 2 were BART-eligible, but disapproved ADEQ's determination that the Nelson Lime Plant was not subject to BART.
As explained in the TSD, the baseline emissions estimates and the corresponding modeling results provided by LNA are conservative (i.e., tending to overestimate rather than underestimate the impacts, in this case). Nonetheless, we consider these results to be appropriate for purposes of a subject-to-BART determination, as well as for the five-factor BART analysis. LNA's modeling results indicate that the 98th percentile impact for each of the 3 years modeled is well over 0.5 dv at Grand Canyon National Park.
For our NO
EPA proposes to find that SNCR is the only technically feasible control option to control NO
EPA conducted a five-factor BART analysis of SNCR to evaluate its cost-effectiveness and visibility benefit. This analysis indicates that SNCR is cost-effective and results in visibility improvement.
Table 22 represents the 98th percentile by the 22nd high over the 2001-2003 period using visibility method “8b.” Using the EPA procedure, the maximum impact still occurs at the Grand Canyon, at 1.8 dv. The 98th percentile impacts at other Class I areas are about 0.3 dv or below, and the cumulative impact is 3.3 dv. The maximum visibility improvement due to SNCR is 0.58 dv, and cumulative improvement is 0.85 dv. There is little improvement at areas other than the Grand Canyon. These improvements yield a visibility cost-effectiveness of $1.4 million/dv using the maximum, and $0.9 million/dv using the cumulative improvement. These visibility improvements support the choice of SNCR as BART for NO
We propose to find that BART for NO
We propose to require compliance with this requirement within three years after the effective date of the final rule. A 2006 Institute of Clean Air Companies (ICAC) study indicated that the installation time for a typical SNCR retrofit, from bid to startup-up, is 10-13 months.
For our BART analysis, we identify all available control technologies, eliminate options that are not technically feasible, and evaluate the control effectiveness of the remaining control options. We then evaluate each control in terms of a five-factor BART analysis and make a determination for BART.
EPA proposes to find that DSI and switching to lower sulfur fuel are technically feasible controls, while wet or semi-dry scrubbing is not technically feasible.
As noted in fuel usage and purchase records, the Nelson Plant currently operates on a coal and petroleum coke mixture. As a result, we consider adjusting the coal/coke ratio in the fuel mixture to be a technically feasible option. We note, however, that since the BART Guidelines do not require fuel supply changes to be considered as a control option, we have typically not considered changes in fuel in BART analyses.
EPA conducted a five-factor BART analysis of the two technically feasible control options, DSI and lower sulfur fuel, to evaluate the cost-effectiveness and visibility benefit of each option along with any effect on the other factors.
While we consider it appropriate to use 40 percent control efficiency
In estimating the costs of compliance, LNA relied on a vendor quote for purchased equipment provided by Noltech dated May 22, 2013, with the remainder of the capital costs calculated using the cost methodology contained in EPA's Control Cost Manual.
We propose to find that BART for SO
For our BART analysis, we identified fabric filter baghouses, the existing control technology for PM
The Nelson Plant, as a major source of hazardous air pollutants (HAPs), is subject to the Maximum Achievable Control Technology (MACT) Standard for Lime Manufacturing Plants, and is required to meet an emission limit of 0.12 lbs PM/TSF (ton of stone feed).
The BART Guidelines provide that, in instances where a source already has the most stringent controls available (including all possible improvements), it is not necessary to complete each step of the BART analysis. Further, as long as the most stringent controls available are made federally enforceable for the purpose of implementing BART for that source, one may skip the remainder of the analysis, including the visibility analysis.
We propose a BART emission limit of 0.12 lb/TSF to control PM
EPA identified two available technology options to control the 20,341 tons of SO
Based on the results of our BART analysis, we propose that BART for SO
Regarding the other options, a wet scrubber for the secondary capture (Option 2) is less effective at a similar annual cost but with greater non-air environmental impacts. Therefore, we do not propose to require this as BART. Adding a scrubber to the existing acid tail stack for the primary capture (Option 3) would result in a relatively small amount of additional emissions reductions at a relatively high cost ($13,564 per ton of SO
The specifics of our BART proposal for SO
• An SO
• Compliance with the SO
• Operation and maintenance of primary and secondary capture systems meeting the requirements of 40 CFR part 63, subpart QQQ.
We propose to require that these requirements be met within 3 years of promulgation of the final rule, consistent with the requirement of the CAA and the RHR that BART be installed “as expeditiously as practicable.”
We identified the same two control technologies for the anode furnaces: a new double contact acid plant and a wet scrubber. In addition, we considered whether emissions from the anode furnaces might be vented to the existing acid plant.
Given the high cost of control, and the small potential for visibility improvement, we propose that controlling the 37 tpy of SO
In order to ensure that emissions from anode furnaces do not increase substantially in the future, we are proposing to establish a work practice standard for these units. While BART determinations are generally promulgated in the form of numeric emission limitations, the RHR allows for use of equipment requirements or work practice standards in lieu of a numeric limit where “technological or economic limitations on the applicability of measurement methodology to a particular source would make the imposition of an emission standard infeasible.”
As explained in our final rule on the Arizona RH SIP, once a source is determined to be subject to BART, the RHR allows for the exemption of a specific pollutant from a BART analysis only if the potential to emit for that pollutant is below a specified de minimis level.
The Hayden Smelter's NO
Given the small potential for visibility improvement, we propose that controlling these NO
We propose that BART for SO
We are seeking comment on all aspects of this proposal. In particular, we are seeking comment on the following elements of our BART analysis and determination for SO
• The cost of controls;
• the collection efficiency for the primary collection system;
• the collection efficiency for the secondary collection system;
• the control efficiency to be applied to the primary and secondary collections systems;
• the compliance methodology; and
• the compliance schedule.
FMMI also reports potentially BART-eligible NO
An additional complication for this facility is that most of the emissions occur via a “roofline,” a long rectangular hole in the roof of the building containing the converters. Modeling the roofline as if it were a stack may be problematic, especially for nearby Class I areas. Modeling the roofline as a buoyant line source is a better characterization of the source. EPA performed sensitivity simulations, described in the TSD, and found that impacts do vary depending on whether it is modeled as a stack or a line source. Which modeling scenario resulted in higher impacts depended on the particular Class I area. EPA therefore modeled the main emissions from FMMI as a buoyant line source, despite the considerably longer model run times.
We identified two available and feasible technologies to control SO
In order to analyze options for improved capture, we requested information from FMMI regarding potential design improvements, upgrades to existing equipment or new equipment that could increase the degree of capture of SO
The purpose of the secondary capture system is to improve capture and control of SO
Based on the results of our BART analysis, we propose that BART for SO
• Construction of a secondary capture system consistent with the requirements of MACT QQQ as a work practice standard.
• An SO
• Compliance with the SO
We are also seeking comment on whether FMMI should be expected to meet a 99.8 percent control efficiency, 30-day rolling average, on all SO
EPA identified two possible technologies to control SO
Based on the high cost of compliance to upgrade the vent fume scrubber and low potential for visibility improvement, we are proposing that existing controls represent BART for SO
NO
In our final rule on the Arizona RH SIP published on July 30, 2013, we partially approved and partially disapproved the State's RP analysis.
EPA conducted an extensive statewide analysis of NO
To identify point sources in Arizona that potentially affect visibility in Class I areas, EPA examined the annual emissions data from the WRAP 2002 planning inventory and identified those sources with facility-wide actual emissions that exceed 250 tpy of NO
Based on our analyses, we believe that a State that has established 0.5 deciviews as a contribution threshold could reasonably exempt from the BART review process sources that emit less than 500 tpy of NO
Of the sources listed in Table 39, we eliminated several sources from further consideration by calculating updated Q/D values based on 2008-2010 emission data.
Finally, we eliminated from further consideration those sources (or units at sources) that were evaluated under BART. These include the Apache Generating Station, Coronado Generating Station, Cholla Power Plant (except Unit 1), Sundt Generating Station (except for Units 1-3), Snowflake Pulp and Paper Mill, and Nelson Lime Plant. Because the BART analysis examines many of the same factors as those evaluated for reasonable progress, we propose that the BART determinations for these facilities satisfy the requirement for reasonable progress from these facilities during this planning period. The final list of sources considered for reasonable progress NO
EPA contracted with the University of North Carolina (UNC) and their subcontractor, Andover Technology Partners (ATP), to perform RP analyses for the nine sources listed in Table 40. EPA considered the four RP factors for each of these sources based on the work from UNC. In addition, for the larger point sources (EGUs and cement kilns), we conducted CALPUFF modeling to assess the potential visibility benefits of controls.
Phoenix Cement is only 10.5 km away from the Sycamore Canyon Wilderness. Therefore NO
We are also soliciting comment on the possibility of establishing an annual cap on NO
The facility consists of three long dry kilns (Kilns 1-3) and one precalciner kiln (Kiln 4). Due to the significant differences between long dry kilns and precalciner kilns, we have separately analyzed Kilns 1-3 and Kiln 4.
Kilns 1-3 have not operated since 2008 due to economic conditions. However, CPCC retains the ability to start using these kilns again at any time. Therefore, we conducted an analysis of the kilns using pre-2008 emission levels.
As discussed above in the section covering visibility improvements for TEP Sundt, EPA remodeled impacts at Saguaro NP to address both the eastern and western units of the park. The modeled visibility impact at the western unit of Saguaro, not shown in the table, is 6.04 dv, far greater than at the eastern unit. The modeled improvement there due to SNCR is 0.30 dv, still rather modest but 25 percent greater than for the eastern unit. However, CalPortland is only 7.8 km away from the western unit, so its emitted NO
The site also includes four 370 hp engines. EPA's analysis indicates that the most cost-effective control would be a three-way catalyst that would reduce emissions by 96 tons per year at a cost of $290/ton.
The initial step in our area source RP analysis was the identification of specific SO
a. Approach to Area Source Analysis
In conducting an RP analysis for area source, EPA encountered significant limitations on the availability and accuracy of data concerning the relevant source categories. For purposes of emission inventory development, an area source is not a single facility, but a category of polluting sources known to exist within a certain geographic area (such as a county), whose actual number, age, and design is not known. The emissions from area sources are usually estimated based on a “top-down” method, where a surrogate piece of information, such as the number of people living in a county or the gallons of diesel fuel sold there in a given year, is used to estimate emissions. Each of the source categories analyzed has an emissions estimate derived from Federal, state, or local databases of fuel consumption. In the aggregate, these numbers are sufficiently accurate for most analyses. However, they do not provide adequate detail for EPA to precisely estimate the actual costs and benefits of controlling the existing population of sources.
Given these limitations in available data, EPA's analyses of area sources are limited in scope. For each category we have developed ranges for the estimated cost of compliance and general information about each of the other factors, based largely on data from three sources: the WRAP Four-Factor Analysis report,
• LNB: $400-7,000/ton;
• LNB/OFA: $400-7,000/ton;
• SNCR: $400-6,900/ton;
• SCR: $1,000-8,000/ton.
The estimated cost-effectiveness values for SO
• DSI: $5,000-11,000/ton;
• Wet FGD: $6,000-13,000/ton.
• Ignition timing retard: $1,000-2,200/ton;
• Exhaust Gas Recirculation: $780-2,000/ton;
• SCR: $3,000-7,700/ton;
• Replacement with Tier 4 engines: $900-2,400/ton.
• Replace space heaters with Low NO
• Replace water heaters with Low NO
As indicated in Tables 53 and 54, area sources in Arizona currently comprise a relatively small portion of the visibility impairment due to nitrate and sulfate, so the potential visibility benefits of NO
EPA proposes to find that it is not reasonable to require additional controls on area sources of NO
We are proposing reasonable progress goals (RPGs) that are consistent with the combination of control measures included in the Arizona RH SIP measures that we previously approved;
While we would prefer to quantify these proposed RPGs for each of Arizona's 12 Class I areas based on the new state and federal plans, we lack sufficient time and resources to conduct the type of regional-scale modeling required to develop such numerical RPGs.
As explained in our proposed and final rules on the Arizona RH SIP, the State set RPGs that provide for slower rates of improvement in visibility than the URP for each of the State's twelve Class I areas.
In our final rule on the Arizona RH SIP published on July 30, 2013, we disapproved portions of the State's LTS related to three RHR requirements. These requirements were for measures needed to achieve emission reductions for out-of-state Class I areas, emissions limitations and schedules for compliance to achieve the reasonable progress goals, and enforceability of emissions limitations and control measures.
Under the RHR, where a state has participated in a regional planning process, the state's LTS must include all measures needed to achieve that state's apportionment of emission reduction obligations agreed upon through that process.
One of the factors a state must consider in developing its LTS is emissions limitations and schedules for compliance to achieve the State's RPGs for its own Class I areas.
Another factor a state must consider in developing its LTS is the enforceability of emissions limitations and control measures.
The primary flaw in Arizona's LTS is the lack of enforceable emission limitations for BART controls. We propose to remedy this deficiency by promulgating BART emission limitations and compliance schedules as
As part of our final rule published on December 5, 2012, regarding BART for Apache Generating Station, Cholla Power Plant and Coronado Generating Station, we promulgated compliance deadlines and requirements for equipment maintenance and operation including monitoring, recordkeeping and reporting, to ensure the enforceability of both Arizona's and EPA's BART determinations.
As described above, today, we are proposing to promulgate similar requirements for the remaining subject-to-BART sources and pollutants in Arizona. We are also proposing emission limitations and compliance requirements for two RP sources: the Phoenix Cement Clarkdale Plant and the CalPortland Rillito Plant.
The final element of our proposed LTS consists of enforceable emission limitations and associated requirements for PM
In its BART analysis for PM
In the Arizona Regional Haze SIP, ADEQ determined that the NESHAP for Primary Copper Smelting constitutes BART for PM emissions from the Miami Smelter. Because the FMMI smelter is a major source of Hazardous Air Pollutants (HAPs), and therefore subject to the requirements of the NESHAP, these requirements are already incorporated into the facility's Title V permit.
We propose that a combination of SIP and FIP measures will satisfy the FIP obligation for the visibility requirement of CAA section 110(a)(2)(D)(i)(II) for the 1997 8-hour ozone, 1997 PM
As a result of the partial disapprovals of the Arizona RH SIP, we found that the Arizona SIP did not contain adequate provisions to prohibit emissions that may interfere with SIP measures required of other states to protect visibility. Therefore, we disapproved Arizona's submittals with respect to the interstate transport visibility requirement for the 1997 8-hour ozone, 1997 PM
We propose to find that the combination of elements in the applicable RH SIPs and FIPs will contain adequate provisions to prohibit emissions from Arizona that would interfere with SIP measures required of other states to protect visibility. These elements are the Arizona RH SIP measures that we previously approved;
EPA is proposing a FIP to address the remaining portions of the Arizona's RH SIP that we disapproved on July 30, 2013, which includes requirements for Best Available Retrofit Technology, Reasonable Progress, and the Long-term
We propose that the interstate transport visibility requirement of section 110(a)(2)(D)(i)(II) for the 1997 8-hour ozone, 1997 PM
This proposed action is not a “significant regulatory action” under the terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and is therefore not subject to review under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011). The proposed FIP applies to only six facilities. It is therefore not a rule of general applicability.
This proposed action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. Under the Paperwork Reduction Act, a “collection of information” is defined as a requirement for “answers to * * * identical reporting or recordkeeping requirements imposed on ten or more persons * * *.” 44 U.S.C. 3502(3)(A). Because the proposed FIP applies to just six facilities, the Paperwork Reduction Act does not apply. See 5 CFR 1320(c). Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; 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; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. 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 Office of Management and Budget (OMB) control number. The OMB control numbers for our regulations in 40 CFR are listed in 40 CFR part 9.
The Regulatory Flexibility Act (RFA) generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions. For purposes of assessing the impacts of today's proposed rule on small entities, small entity is defined as: (1) A small business as defined by the Small Business Administration's (SBA) regulations at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for profit enterprise which is independently owned and operated and is not dominant in its field.
After considering the economic impacts of this proposed action on small entities, I certify that this proposed action will not have a significant economic impact on a substantial number of small entities. None of the facilities subject to this proposed rule is owned by a small entity.
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and Tribal governments and the private sector. Under section 202 of UMRA, EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures to State, local, and Tribal governments, in the aggregate, or to the private sector, of $100 million or more (adjusted for inflation) in any 1 year. Before promulgating an EPA rule for which a written statement is needed, section 205 of UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective, or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 of UMRA do not apply when they are inconsistent with applicable law. Moreover, section 205 of UMRA allows EPA to adopt an alternative other than the least costly, most cost-effective, or least burdensome alternative if the Administrator publishes with the final rule an explanation why that alternative was not adopted. Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including Tribal governments, it must have developed under section 203 of UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements.
Under Title II of UMRA, EPA has determined that this proposed rule does not contain a Federal mandate that may result in expenditures that exceed the inflation-adjusted UMRA threshold of $100 million by State, local, or Tribal governments or the private sector in any 1 year. In addition, this proposed rule does not contain a significant Federal intergovernmental mandate as described by section 203 of UMRA nor does it contain any regulatory requirements that might significantly or uniquely affect small governments.
Executive Order 13132 Federalism (64 FR 43255, August 10, 1999) revokes and replaces Executive Orders 12612 (Federalism) and 12875 (Enhancing the Intergovernmental Partnership). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” Under Executive Order 13132, EPA may not issue a regulation that has federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, or EPA consults with State and local officials early in the process of developing the proposed regulation. EPA also may not issue a regulation that has federalism implications and that preempts State law unless the Agency consults with State and local officials early in the process of developing the proposed regulation.
This rule 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, as specified in Executive Order 13132. In this action, EPA is fulfilling our statutory duty under CAA Section 110(c) to promulgate a partial Regional Haze FIP. Thus, Executive Order 13132 does not apply to this action. In the spirit of Executive Order 13132, and consistent with EPA policy to promote communications between EPA and State and local governments, EPA specifically solicits comment on this proposed rule from State and local officials.
Subject to the Executive Order 13175 (65 FR 67249, November 9, 2000) EPA may not issue a regulation that has tribal implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by tribal governments, or EPA consults with tribal officials early in the process of developing the proposed regulation and develops a tribal summary impact statement.
EPA has concluded that this action, if finalized, will have tribal implications, because it will impose substantial direct compliance costs on tribal governments, and the Federal government will not provide the funds necessary to pay those costs. PCC is a division of Salt River Pima Maricopa Indian Community (SRPMIC or the Community) and profits from the Phoenix Cement Clarkdale Plant are used to provide government services to SRPMIC's members. Therefore, EPA is providing the following tribal summary impact statement as required by section 5(b).
EPA consulted with tribal officials early in the process of developing this regulation to permit them to have meaningful and timely input into its development. In November 2012, we shared our initial analyses with SRPMIC and PCC to ensure that the tribe had an early opportunity to provide feedback on potential controls at the Clarkdale Plant. PCC submitted comments on this initial analysis as part of the rulemaking on the Arizona Regional Haze SIP and we revised our initial analysis based on these comments. On November 6, 2013, the EPA Region 9 Regional Administrator met with the President and other representatives of SRPMIC to discuss the potential impacts of the FIP on SRPMIC. Following this meeting, staff from EPA, SPRMIC and PCC shared further information regarding the Plant and potential impacts of the FIP on SRPMIC.
During these consultations, SRPMIC expressed its concern regarding the potential financial impacts of any new controls that might be required at the Clarkdale Plant. In particular, SRPMIC requested that EPA provide PCC with an extended compliance schedule for any controls in order to enable PCC and SRPMIC to plan for such controls in their long-term budgets and thus mitigate the potential impacts to the Community.
As explained above, EPA is proposing to determine that it is reasonable to require installation of SNCR at Kiln 4 at the Clarkdale Plant by December 31, 2018. EPA is also seeking comment on the possibility of establishing an annual cap on NO
Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), applies to any rule that: (1) Is determined to be economically significant as defined under Executive Order 12866; and (2) concerns an environmental health or safety risk that we have reason to believe may have a disproportionate effect on children. EPA interprets EO 13045 as applying only to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of the EO has the potential to influence the regulation. This action is not subject to EO 13045 because it implements specific standards established by Congress in statutes. However, to the extent this proposed rule will limit emissions of NO
This action is not subject to Executive Order 13211 (66 FR 28355 (May 22, 2001)), because it is not a significant regulatory action under Executive Order 12866.
Section 12 of the National Technology Transfer and Advancement Act (NTTAA) of 1995 requires Federal agencies to evaluate existing technical standards when developing a new regulation. To comply with NTTAA, EPA must consider and use “voluntary consensus standards” (VCS) if available and applicable when developing programs and policies unless doing so would be inconsistent with applicable law or otherwise impractical. EPA believes that VCS are inapplicable to this action. Today's action does not
Executive Order 12898 (59 FR 7629, February 16, 1994), establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States.
We have determined that this proposed rule, if finalized, will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it increases the level of environmental protection for all affected populations without having any disproportionately high and adverse human health or environmental effects on any population, including any minority or low-income population. This proposed federal rule limits emissions of NO
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen oxides, Sulfur dioxide, Particulate matter, Reporting and recordkeeping requirements, Visibility, Volatile organic compounds.
42 U.S.C. 7401 et seq.
Part 52, chapter I, title 40 of the Code of Federal Regulations is proposed to be amended as follows:
42 U.S.C. 7401
(i)
(2)
(3)
(4)
(ii) The owner/operator of each unit shall comply with the SO
(5)
(ii)
(iii)
(iv)
(6)
(i) All CEMS data, including the date, place, and time of sampling or measurement; parameters sampled or measured; and results.
(ii) All records of lime production.
(iii) Daily 30-day rolling emission rates of NO
(iv) Records of quality assurance and quality control activities for emissions measuring systems including, but not limited to, any records required by 40 CFR part 60, appendix F, Procedure 1.
(v) Records of ammonia consumption, as recorded by the instrumentation required in paragraph (i)(5)(ii) of this section.
(vi) Records of all major maintenance activities conducted on emission units, air pollution control equipment, CEMS and clinker production measurement devices.
(vii) Any other records required by 40 CFR part 60, Subpart F, or 40 CFR part 60, Appendix F, Procedure 1.
(7)
(i) The owner/operator shall submit a report that lists the daily 30-day rolling emission rates for NO
(ii) The owner/operator shall submit excess emissions reports for NO
(iii) The owner/operator shall submit CEMS performance reports, to include dates and duration of each period during which the CEMS was inoperative (except for zero and span adjustments and calibration checks), reason(s) why the CEMS was inoperative and steps taken to prevent recurrence, and any CEMS repairs or adjustments.
(iv) The owner/operator shall also submit results of any CEMS performance tests required by 40 CFR part 60, appendix F, Procedure 1 (Relative Accuracy Test Audits, Relative Accuracy Audits, and Cylinder Gas Audits).
(v) When no excess emissions have occurred or the CEMS has not been inoperative, repaired, or adjusted during the reporting period, the owner/operator shall state such information in the semiannual report.
(8)
(ii) The owner/operator shall submit semiannual progress reports on construction of any such equipment.
(iii) The owner/operator shall submit notification of initial startup of any such equipment.
(9)
(ii) After completion of installation of ammonia injection on a unit, the owner or operator shall inject sufficient ammonia to achieve compliance with NO
(10)
(11)
(i) R-18-2-101, paragraph 65;
(ii) R18-2-310, sections (A), (B), (D) and (E) only; and
(iii) R18-2-310.01.
(j)
(2)
(3)
(4)
(i) The owner/operator of the unit shall combust only pipeline natural gas in the subject unit.
(ii) The owner/operator of the unit shall not emit or cause to be emitted pollutants in excess of the following limitations, in pounds of pollutant per million british thermal units (lb/MMBtu), from the subject unit.
(5)
(ii) The owner/operator of the unit subject to this paragraph shall comply with the PM emissions limitations of paragraph (j)(3) of this section no later than April 16, 2015.
(6)
(7)
(B) The owner/operator of the unit shall comply with the quality assurance procedures for CEMS found in 40 CFR Part 75. In addition to these Part 75 requirements, relative accuracy test audits shall be calculated for both the NO
(ii)
(iii)
(iv)
(v)
(8)
(i)
(B) The owner/operator of the unit shall comply with the quality assurance procedures for CEMS found in 40 CFR part 75. In addition to these part 75 requirements, relative accuracy test audits shall be calculated for both the NO
(ii)
(iii)
(iv)
(9)
(i) CEMS data measuring NO
(ii) Daily 30-day rolling emission rates of NO
(iii) Records of the relative accuracy test for NO
(iv) Records of quality assurance and quality control activities for emissions systems including, but not limited to, any records required by 40 CFR part 75.
(v) Records of all major maintenance activities conducted on emission units, air pollution control equipment, and CEMS.
(vi) Any other records required by 40 CFR part 75.
(vii) Records of ammonia consumption for the unit, as recorded by the instrumentation required in paragraph (j)(7)(ii) of this section.
(viii) All PM stack test results.
(10)
(i) CEMS data measuring NO
(ii) Daily 30-day rolling emission rates of NO
(iii) Records of the relative accuracy test for NO
(iv) Records of quality assurance and quality control activities for emissions systems including, but not limited to, any records required by 40 CFR part 75.
(v) Records of all major maintenance activities conducted on emission units, air pollution control equipment, and CEMS.
(vi) Any other records required by 40 CFR part 75.
(vii) Records sufficient to demonstrate that the fuel for the unit is pipeline natural gas.
(viii) All PM
(11)
(ii) The owner/operator shall notify EPA of commencement of construction of any equipment which is being constructed to comply with either the NO
(iii) The owner/operator shall submit semiannual progress reports on construction of any such equipment.
(iv) The owner/operator shall submit notification of initial startup of any such equipment.
(12)
(i) The owner/operator shall submit a report that lists the daily 30-day rolling emission rates for NO
(ii) The owner/operator shall submit excess emission reports for NO
(iii) The owner/operator shall submit CEMS performance reports, to include dates and duration of each period during which the CEMS was inoperative (except for zero and span adjustments and calibration checks), reason(s) why the CEMS was inoperative and steps taken to prevent recurrence, and any CEMS repairs or adjustments.
(iv) The owner/operator shall submit the results of any relative accuracy test audits performed during the two preceding calendar quarters.
(v) When no excess emissions have occurred or the CEMS has not been inoperative, repaired, or adjusted during the reporting period, the owner/operator shall state such information in the semiannual report.
(vi) The owner/operator shall submit results of any PM stack tests conducted for demonstrating compliance with the PM limit specified in paragraph (j)(3).
(13)
(i) The owner/operator shall submit a report that lists the daily 30-day rolling emission rates for NO
(ii) The owner/operator shall submit excess emissions reports for NO
(iii) The owner/operator shall submit CEMS performance reports, to include dates and duration of each period during which the CEMS was inoperative (except for zero and span adjustments and calibration checks), reason(s) why the CEMS was inoperative and steps taken to prevent recurrence, and any CEMS repairs or adjustments.
(iv) The owner/operator shall submit the results of any relative accuracy test audits performed during the two preceding calendar quarters.
(v) When no excess emissions have occurred or the CEMS has not been inoperative, repaired, or adjusted during the reporting period, the owner/operator shall state such information in the semiannual report.
(vi) The owner/operator shall submit results of any PM
(14)
(ii) After completion of installation of ammonia injection on a unit, the owner or operator shall inject sufficient ammonia to achieve compliance with NO
(15)
(16)
(i) R-18-2-101, paragraph 65;
(ii) R18-2-310, sections (A), (B), (D) and (E) only; and
(iii) R18-2-310.01.
(k)
(2)
(3)
(4)
(5)
(B) At all times after the compliance date specified in paragraph (k)(4) of this section, the owner/operator of the unit at the Rillito Plant shall maintain, calibrate, and operate a CEMS, in full compliance with the requirements found at 40 CFR 60.63(f) and (g), to accurately measure concentration by volume of NO
(ii)
(B)(
(
(C) At the end of each kiln operating day, the owner/operator shall calculate and record a new 30-day rolling average emission rate in lb/ton clinker from the arithmetic average of all valid hourly emission rates for the current kiln operating day and the previous 29 successive kiln operating days.
(D) Upon and after the completion of installation of ammonia injection on a unit, the owner/operator shall install, and thereafter maintain and operate, instrumentation to continuously monitor and record levels of ammonia consumption that unit.
(6)
(i) All CEMS data, including the date, place, and time of sampling or measurement; parameters sampled or measured; and results.
(ii) All records of clinker production.
(iii) Daily 30-day rolling emission rates of NO
(iv) Records of quality assurance and quality control activities for emissions measuring systems including, but not limited to, any records required by 40 CFR part 60, appendix F, Procedure 1.
(v) Records of ammonia consumption, as recorded by the instrumentation required in paragraph (k)(5)(ii)(D) of this section.
(vi) Records of all major maintenance activities conducted on emission units, air pollution control equipment, CEMS and clinker production measurement devices.
(vii) Any other records required by 40 CFR part 60, Subpart F, or 40 CFR part 60, Appendix F, Procedure 1.
(7)
(i) The owner/operator shall submit a report that lists the daily 30-day rolling emission rates for NO
(ii) The owner/operator shall submit excess emissions reports for NO
(iii) The owner/operator shall submit CEMS performance reports, to include dates and duration of each period during which the CEMS was inoperative (except for zero and span adjustments and calibration checks), reason(s) why the CEMS was inoperative and steps taken to prevent recurrence, and any CEMS repairs or adjustments.
(iv) The owner/operator shall also submit results of any CEMS performance tests required by 40 CFR part 60, appendix F, Procedure 1 (Relative Accuracy Test Audits, Relative Accuracy Audits, and Cylinder Gas Audits).
(v) When no excess emissions have occurred or the CEMS has not been inoperative, repaired, or adjusted during the reporting period, the owner/operator shall state such information in the reports required by paragraph (k)(7)(ii) of this section.
(8)
(ii) The owner/operator shall submit semiannual progress reports on construction of any such equipment.
(iii) The owner/operator shall submit notification of initial startup of any such equipment.
(9)
(ii) After completion of installation of ammonia injection on a unit, the owner or operator shall inject sufficient ammonia to achieve compliance with NO
(10)
(11)
(i) R-18-2-101, paragraph 65;
(ii) R18-2-310, sections (A), (B), (D) and (E) only; and
(iii) R18-2-310.01.
(l)
(2)
(3)
(4)
(ii) The owner/operator must not cause or allow to be discharged to the atmosphere from any primary capture system required by paragraph (l)(3) off-gas that contains nonsulfuric acid particulate matter in excess of 6.2 mg/dscm as measured using the test methods specified in 40 CFR 63.1450(b).
(iii) The owner/operator must not cause or allow to be discharged to the atmosphere from any secondary capture system required by paragraph (l)(3) of this section off-gas that contains particulate matter in excess of 23 mg/dscm as measured using the test methods specified in 40 CFR 63.1450(a).
(iv) Total NO
(v) Anode furnaces #1 and #2 shall only be charged with blister copper or higher purity copper.
(5)
(6)
(ii)
(iii)
(iv)
(v)
(7)
(i)
(ii)
(iii)
(8)
(9)
(i) All CEMS data, including the date, place, and time of sampling or measurement; parameters sampled or measured; and results.
(ii) Records of quality assurance and quality control activities for emissions measuring systems including, but not limited to, any records required by 40 CFR part 60, appendix F, Procedure 1.
(iii) Records of all major maintenance activities conducted on emission units, air pollution control equipment, and CEMS.
(iv) Any other records required by 40 CFR part 60, Subpart F, or 40 CFR part 60, Appendix F, Procedure 1.
(v) Records of all monitoring required by paragraph (l)(8) of this section.
(vi) Records of daily sulfuric acid production in tons per day of pure sulfuric acid if the owner/operator chooses to use the alternative compliance determination method in paragraph (l)(7) of this section.
(vii) Records of daily natural gas consumption in each units identified in paragraph (l)(1) and all calculations performed to demonstrate compliance with the limit in paragraph (l)(4)(iv).
(10)
(i) The owner/operator shall promptly submit excess emissions reports for the SO
(ii) The owner/operator shall submit CEMS performance reports, to include dates and duration of each period during which the CEMS was inoperative (except for zero and span adjustments and calibration checks), reason(s) why the CEMS was inoperative and steps taken to prevent recurrence, and any CEMS repairs or adjustments. The owner/operator shall submit reports semiannually.
(iii) The owner/operator shall also submit results of any CEMS performance tests required by 40 CFR part 60, appendix F, Procedure 1 (Relative Accuracy Test Audits, Relative Accuracy Audits, and Cylinder Gas Audits).
(iv) When no excess emissions have occurred or the CEMS has not been inoperative, repaired, or adjusted during the reporting period, the owner/operator shall state such information in the semiannual report.
(v) When performance testing is required to determine compliance with an emission limit in paragraph (l)(4) of this section, the owner/operator shall submit test reports as specified in 40 CFR part 63, subpart A.
(11)
(ii) The owner/operator shall submit semiannual progress reports on construction of any such equipment.
(iii) The owner/operator shall submit notification of initial startup of any such equipment.
(12)
(13)
(14)
(i) R-18-2-101, paragraph 65;
(ii) R18-2-310, sections (A), (B), (D) and (E) only; and
(iii) R18-2-310.01.
(m)
(2)
(3)
(4)
(ii) Total NO
(iii) The owner/operator shall not actively aerate the electric furnace.
(5)
(6)
(ii)
(iii)
(7)
(i)
(ii)
(iii)
(8)
(9)
(i) All CEMS data, including the date, place, and time of sampling or measurement; parameters sampled or measured; and results.
(ii) Records of quality assurance and quality control activities for emissions measuring systems including, but not limited to, any records required by 40 CFR part 60, appendix F, Procedure 1.
(iii) Records of all major maintenance activities conducted on emission units, air pollution control equipment, and CEMS.
(iv) Any other records required by 40 CFR part 60, Subpart F, or 40 CFR part 60, Appendix F, Procedure 1.
(v) Records of all monitoring required by paragraph (m)(8) of this section.
(vi) Records of daily sulfuric acid production in tons per day of pure sulfuric acid if the owner/operator chooses to use the alternative compliance determination method in paragraph (m)(7) of this section.
(vii) Records of daily natural gas consumption in each units identified in paragraph (m)(1) and all calculations performed to demonstrate compliance with the limit in paragraph (m)(4)(iv).
(10)
(i) The owner/operator shall promptly submit excess emissions reports for the SO
(ii) The owner/operator shall submit CEMS performance reports, to include dates and duration of each period during which the CEMS was inoperative (except for zero and span adjustments and calibration checks), reason(s) why the CEMS was inoperative and steps taken to prevent recurrence, and any CEMS repairs or adjustments. The owner/operator shall submit reports semiannually.
(iii) The owner/operator shall also submit results of any CEMS performance tests required by 40 CFR part 60, appendix F, Procedure 1 (Relative Accuracy Test Audits, Relative Accuracy Audits, and Cylinder Gas Audits).
(iv) When no excess emissions have occurred or the CEMS has not been inoperative, repaired, or adjusted during the reporting period, the owner/operator shall state such information in the semiannual report.
(v) When performance testing is required to determine compliance with an emission limit in paragraph (m)(4) of this section, the owner/operator shall submit test reports as specified in 40 CFR part 63, subpart A.
(11)
(ii) The owner/operator shall submit semiannual progress reports on construction of any such equipment.
(iii) The owner/operator shall submit notification of initial startup of any such equipment.
(12)
(13)
(14)
(i) R-18-2-101, paragraph 65;
(ii) R18-2-310, sections (A), (B), (D) and (E) only; and
(iii) R18-2-310.01.