During the late 1800s, gorse was introduced into North America from Western Europe. Gorse ( Ulex eurpaeus ) is a spiny shrub found in eastern States, Washington, Oregon, California, and Hawaii. This plant is most often a pest of disturbed sites in open wild or less-developed areas where management is minimal or non-existent. Gorse's invasiveness is most prolific in the maritime climate within a few miles of the ocean, where sandy soils and rocky outcrops are especially vulnerable to invasion. Gorse's impacts include displacement of native plants, including forest tree saplings, reduction in the quality of wildlife habitats, increased fire hazard, interference in rights-of-way and recreation sites, and reduced livestock forage production.

The insect Sericothrips staphylinus was chosen as a potential biological control agent. Although specific information as to the extent of its range has been difficult to obtain, the native distribution of the agent is assumed to overlap with the majority of the range of gorse in Europe.

The Animal and Plant Health Inspection Service's (APHIS') review and analysis of the potential environmental impacts associated with the proposed release are documented in detail in an environmental assessment (EA) entitled “Field Release of the thrips Sericothrips staphylinus (Thysanoptera: Thripidae) for biological control of gorse, Ulex europaeus (Fabaceae), in the contiguous United States” (July 2019). We are making the EA available to the public for review and comment. We will consider all comments that we receive on or before the date listed under the heading DATES at the beginning of this notice.

The EA may be viewed on the Regulations.gov website or in our reading room (see ADDRESSES above for a link to Regulations.gov and information on the location and hours of the reading room). You may also request paper copies of the EA by calling or writing to the person listed under FOR FURTHER INFORMATION CONTACT . Please refer to the title of the EA when requesting copies.

The EA has been prepared in accordance with: (1) The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq. ), (2) regulations of the Council on Environmental Quality for implementing the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA Implementing Procedures (7 CFR part 372).

Title: Section 515 Multifamily Preservation and Revitalization (MPR) Demonstration Program.

OMB Control Number: 0575-0190.

Type of Request: Extension of currently approved information collection.

Abstract: The Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriation Act, 2006 (Pub. L. 109-97) provides funding for, and authorizes Rural Development to conduct a demonstration program for the preservation and revitalization of the Section 515 Multi-Family Housing portfolio. Section 515 of the Housing Act of 1949 (42 U.S.C. 1485) provides Rural Development the authority to make loans for low-income Multi-Family Housing and related facilities.

Rural Development refers to this program as Multifamily Preservation and Revitalization (MPR) Demonstration Program. A Notice of Solicitation for Applications (NOSA) sets forth the eligibility and application requirements. Information will be collected from applicants and grant recipients by Rural Development staff in its Local, Area, State, and National Offices. This information will be used to determine applicant eligibility for this demonstration program. If an applicant proposal is selected, that applicant will be notified of the selection and given the opportunity to submit a formal application.

This MPR demonstration program continues to adjust the various opportunities available to demonstrate effective methods of providing the needed financial resources not otherwise available to current owners and transferees. Using alternative forms of financing, these owners will preserve existing Agency-financed Rural Rental Housing and Farm Labor Housing and extend the property's useful life for tenants meeting RD eligibility requirements. Since the inception of the MPR demonstration program in 2006, revisions and adjustments in the nature of the program have necessitated certain revisions in the context, formatting and use of the original forms in this package to permit RD's ability to provide these needed financial opportunities. To meet current Agency NOSA, regulatory and industry standards, the following forms are being revised, reformatted and/or renamed in some instances to provide clarity and consistency in their practical use and application:

Estimate of Burden: Public reporting burden for this collection of information is estimated to average 1 hour per response.

Respondents: Individuals, partnerships, public and private non-profit corporations, agencies, institutions, organizations, and Indian tribes.

Estimated Number of Respondents: 1,500.

Estimated Number of Responses per Respondent: 1.

Estimated Total Annual Burden on Respondents: 18,701 hours.

Copies of this information collection can be obtained from Taylor Abens, Rural Development Innovation Center—Regulatory Team 2, USDA, 1400 Independence Avenue SW, STOP 1522, Room 4233, South Building, Washington, DC 20250-1522. Telephone: (712) 203-5625. Email taylor.abens@usda.gov. All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

The purpose of these advisory guidelines for onboard wheelchairs is to provide air carriers and onboard wheelchair manufacturers with technical assistance in meeting their obligations under the Air Carrier Access Act. 49 U.S.C. 41705. The Department of Transportation has indicated an intent to issue regulations under the Air Carrier Access Act that seek to implement the final resolution of a negotiated rulemaking, described in more detail below. See Resolution of the Department of Transportation Access Committee, Annex A (Nov. 22, 2016), available at https://www.transportation.gov/sites/dot.gov/files/docs/ACCESSCommitteeFinalResolution.11.21.16.pdf. The agreed-upon terms include a requirement for an onboard wheelchair of enhanced functionality on specified commercial aircraft of more than 125 passenger seats. The Department of Transportation has sought technical assistance from the Access Board in providing specifications that would meet a future mandatory performance standard, issued by the Department, for such onboard wheelchairs.

Similar to the existing onboard wheelchair regulations at 14 CFR 382.65(c), it is expected that the new standards the Department of Transportation intends to issue as a result of the negotiated rulemaking will be performance standards. This means that the contemplated regulations would require onboard wheelchairs to have certain features and meet established functional criteria but would not specify technical requirements such as dimensions for specific features. The Access Board's advisory guidelines would serve as technical assistance for covered air carriers, providing one example of how covered air carriers might satisfy the performance standard for onboard wheelchairs established by DOT in its forthcoming rulemaking. These advisory guidelines contain recommended dimensions and other technical specifications that would help manufacturers optimize the design of a comfortable and functional chair and assist air carriers in the selection of onboard wheelchair models that best serve passengers with disabilities. Even if adopted by the Access Board, these guidelines will not be legally binding on any regulated entity. Whether or to what extent DOT subsequently references, incorporates, or adopts these guidelines falls under the department's exclusive authority. Nonetheless, it is the Access Board's understanding that DOT does not intend to issue any regulatory standards that would make non-conformance with these advisory guidelines a separate basis for affirmative enforcement action or imposition of administrative penalties.

In 2016, the Department of Transportation established an Advisory Committee on Accessible Air Transportation (hereafter, “ACCESS Advisory Committee” or “Committee”) to negotiate and develop a proposed rule concerning various accommodations for air travelers with disabilities, including the accessibility of lavatories on new single-aisle aircraft. See Nondiscrimination on the Basis of Disability in Air Travel; Establishment of a Negotiated Rulemaking Committee, 81 FR 20265 (Apr. 7, 2016). The Committee consisted of airline representatives, aircraft manufacturing representatives, representatives from disability rights advocacy organizations, and other stakeholders. 1

The Committee agreed to specific incremental accessibility solutions with respect to aircraft lavatories. The accessibility solutions culminate in the requirement for installation on certain single-aisle aircraft of a lavatory of sufficient size to allow individuals with mobility disabilities to transfer from an onboard wheelchair to the toilet (and vice versa). However, by the terms of the Committee's agreement, it will be at least twenty years before these lavatories are installed in single-aisle aircraft. See Resolution of the Department of Transportation Access Committee, Annex A (Nov. 22, 2016), available at https://www.transportation.gov/sites/dot.gov/files/docs/ACCESSCommitteeFinalResolution.11.21.16.pdf.

In the interim, the Committee agreed to pursue improvements to the onboard wheelchairs that individuals with certain types of mobility disabilities must use to move between the aircraft seat and the lavatory. See Id. DOT currently requires air carriers to provide onboard wheelchairs on most aircraft with more than sixty passenger seats that have an accessible lavatory and when requested by a passenger with a disability even if the aircraft does not have an accessible lavatory. 14 CFR 382.65(b). DOT specifies certain features that onboard wheelchairs must have and performance criteria that they must meet. 14 CFR 382.65(c). Because of the general nature of these performance criteria, there is little standardization across manufacturers with respect to the design of onboard wheelchairs. The Committee agreed to pursue an onboard wheelchair design that, if feasible, could be positioned over a closed toilet to allow for better use of the other features of a lavatory, including the privacy afforded by a closed door. The Committee also acknowledged the existence of safety and usability challenges with traditional onboard wheelchair models. The Committee thus agreed that DOT should develop new standards for onboard wheelchairs, and that, in the future, certain aircraft  2 would be required to provide an onboard wheelchair that meets those standards.

In response to the Committee's agreement, DOT requested technical assistance from the Access Board in developing advisory guidelines that would address the Committee's concerns. The Access Board proposes the below advisory guidelines in response to this request.

The Air Carrier Access Act permits the Department of Transportation to seek assistance from the Access Board for the provision of “technical assistance to air carriers and individuals with disabilities in understanding the rights and responsibilities” under the Act. 49 U.S.C. 41705.

In addition, Section 502 of the Rehabilitation Act of 1973, as amended, tasks the Access Board with statutory authorities relating to transportation barriers confronting persons with disabilities. See 29 U.S.C. 792. Specifically, the Board is directed to “investigate and examine alternative approaches to the architectural, transportation, communication, and attitudinal barriers confronting individuals with disabilities, particularly with respect to telecommunications devices, public buildings and monuments, parks and parklands, public transportation (including air, water, and surface transportation, whether interstate, foreign, intrastate, or local), and residential and institutional housing,” and to “ensure that public conveyances, including rolling stock, are readily accessible to, and usable by, individuals with physical disabilities.” Id. at 792(b)(5) and (b)(10). Further, the Access Board is charged with promoting accessibility throughout all segments of society. Id. at (b)(4).

In these advisory guidelines, the Access Board proposes that the onboard wheelchair be designed such that it can fully enter the aircraft lavatory in a backward orientation, where the seat of the onboard wheelchair slides over the closed toilet allowing the lavatory door to be completely closed with the occupied onboard wheelchair inside. The purpose of allowing the onboard wheelchair to be positioned over the toilet is to provide both privacy and sufficient space for movement so that the occupant can accomplish non-toileting personal hygiene and medically needed tasks in private. In this use, the occupant is not using the toilet. In order to use the toilet, the onboard wheelchair occupant would need to transfer from the onboard wheelchair to the toilet, typically by standing and pivoting 180 degrees. Owing to the small size of lavatories on single-aisle aircraft, such a transfer is typically accomplished with the door to the lavatory open, and the onboard wheelchair partially or fully outside the lavatory. However, many people are unable to perform a stand-and-pivot transfer; the proposed over-toilet positioning would allow these individuals the opportunity to use the lavatory for non-toileting personal hygiene or medically needed tasks that require the privacy afforded by a closed lavatory door.

Over-toilet positioning of the onboard wheelchair was of interest to the members of DOT's ACCESS Advisory Committee and was included in the Committee's final agreement to the extent that such a design is feasible. The Board seeks comment on whether such a design is feasible. The Board is not aware of any commercially available onboard wheelchair that can be positioned over a toilet; however, researchers from Hamburg University of Applied Sciences (Germany) have been developing a prototype with a cantilever design that could be positioned over the toilet. 3 The Board notes that any such design is “feasible” in this context only if it meets all other technical requirements (including collapsibility for storage) and does not involve modification of the aircraft lavatory.

Question 1. Is it feasible to design an onboard wheelchair that can be positioned over a toilet without modification to the aircraft lavatory? Please explain the design and engineering considerations that would impact the ability of the onboard wheelchair to maneuver over the toilet.

Question 2. If feasible, would this onboard wheelchair also be capable of folding and being stored in an FAA-certified stowage space?

Question 3. What are the cost implications associated with the design and manufacture of an onboard wheelchair that can be positioned over a toilet without modification to the aircraft lavatory?

The loads that commercially available onboard wheelchairs support vary widely. For example, the overall weight capacity of currently available models varies from approximately 200 to 800 pounds. In the Access Board's 1987 publication Guidelines for Aircraft Boarding Chairs, 4 we recommended that seats support at least 723 pounds (weight of a 99th percentile male with a 3.0 safety factor). See https://www.access-board.gov/research/completed-research/guidelines-for-aircraft-boarding-chairs. Using updated anthropometrics, the weight of a 99th percentile male with a 3.0 safety factor would be 826 pounds. See Department of Health and Human Service Centers for Disease Control and Prevention's Anthropometric Reference Data for Children and Adults: United States, 2011-2014, Table 6, Line 1 (Aug. 2016). SAE International, in its standard Foldable On-Board Wheelchairs for Passengers with Disabilities, ARP 4120C (Stabilized 2013), requires a different overall load. In the proposed guidelines, the Board reserves provisions for loads related to the seat, arm supports, foot support, casters, and assist handles, pending further information as to what loads are appropriate for an onboard wheelchair design that accomplishes the proposed functions. Specifically, the Board is unaware of any existing industry standards for onboard wheelchairs that are designed to allow over-the-toilet positioning, and therefore does not propose incorporation by reference of the loads of any existing standard, including the loads from the Board's 1987 Guidelines for Aircraft Boarding Chairs, absent further engineering information.

Question 4. If the over-the-toilet positioning is feasible, what should the respective loads be for the seat, arm supports, foot support, casters, and assist handles?

Question 5. If the over-the-toilet positioning is not feasible, what should the respective loads be for the seat, arm supports, foot support, casters, and assist handles?

In the proposed guidelines, Section 1 establishes the purpose and the general requirements for application of the onboard wheelchair guidelines.

The purpose of these technical specifications is to provide technical assistance for the design of an onboard wheelchair with enhanced safety and stability, and that improves the ability of persons with mobility disabilities to have access to and use of the lavatory for toileting and non-toileting privacy needs, such as administering medication or conducting hygiene related tasks in a safe manner.

These Advisory Guidelines for Aircraft Onboard Wheelchairs establish voluntary, non-binding technical guidance for use by airlines and manufacturers of onboard wheelchairs.

These technical specifications take into consideration adult anthropometrics. For anthropometrics, the Board consulted data from the Department of Transportation Federal Aviation Administration Human Factors Design Standard, HF-STD-001B (Dec. 30, 2016), and the Department of Health and Human Services Centers for Disease Control and Prevention's Anthropometric Reference Data for Children and Adults: United States, 2011-2014 (Aug. 2016). In addition, due to the lack of available updated anthropometrics on feet and seated hip breadth, the Board used data from our 1987 Guidelines for Aircraft Boarding Chairs (which references Wesley Woodson's 1981 Human Factors Design Handbook).

The dimensions of the onboard wheelchair must also account for the aircraft dimensions necessary to ensure that the onboard wheelchair fits through the aisle of the aircraft, into the lavatory, and over the toilet. We therefore seek information on the relevant aircraft measurements necessary to determine the appropriate dimensions of an onboard wheelchair that can fully enter an aircraft lavatory and be positioned over the toilet.

Question 6. Is there recent anthropometric data on adult male feet and seated hip breadth that the Access Board should consider?

Question 7. Please provide information on aisle width for single-aisle aircraft with more than 125 passenger seats.

Question 8. Please provide dimensions for lavatories on single-aisle aircraft with more than 125 passenger seats, including: Width of the doorway opening, height of the lavatory doorway threshold, interior width and depth of the lavatory, clear floor space aside the toilet, and available clearances below the toilet bowl.

Dimensions are subject to conventional industry tolerances for manufacturing processes, material properties, and field conditions.

Question 9. What information or resources are available concerning conventional industry tolerances for manufactured equipment such as onboard wheelchairs?

The following terms are defined in the advisory guidelines: Attendant, caster, and onboard wheelchair. These advisory guidelines rely on the definition of other terms as defined by regulations issued by the Department of Transportation under the Air Carrier Access Act. All other terms should be given their ordinary accepted meaning as implied by the context in which the term is used.

Question 10. What other terms, if any, should be defined in this section?

The technical criteria in 201.1 address the required functionality of an onboard wheelchair while occupied by a passenger. The onboard wheelchair must be designed such that it can move both forward and backward through the aisle of the aircraft. The purpose of requiring movement in both directions is to ensure that a forward entry into a lavatory for transfer, as well as a backward entry into the lavatory if the occupant intends to remain in the onboard wheelchair while inside the lavatory, is possible.

Question 11. What concerns are there, if any, about a design that allows for the onboard wheelchair to be maneuvered in both a forward approach and a backward approach to the lavatory?

The purpose of this provision is to ensure that the onboard wheelchair can be maneuvered close enough to the lavatory toilet in a forward orientation such that an occupant who is capable of a stand-and-pivot transfer is able to transfer to the toilet.

In a forward approach to the lavatory, the attendant would push the onboard wheelchair partially into the lavatory using the rear assist handles. Once close enough to the toilet for transfer, the attendant or occupant would apply the wheel locks, and the occupant would then stand and pivot to transfer to the toilet. 5

The purpose of this requirement is to ensure that the onboard wheelchair can successfully maneuver into the lavatory and over the closed toilet in a manner that permits the lavatory door to close completely, providing the occupant with privacy. In this use, the attendant would push the onboard wheelchair backward into the lavatory using the assist handles on the front of the chair. The attendant would push the onboard wheelchair over the closed toilet, which would permit the lavatory door to close completely.

Question 12. What space constraints exist within aircraft lavatories that would prevent the onboard wheelchair from completely entering the lavatory?

Question 13. Are there any protruding objects inside aircraft lavatories that would impede over-toilet positioning? If so, please describe the protruding objects.

When folded, the onboard wheelchair must be maneuverable on its wheels to allow an attendant to transport and stow an unoccupied onboard wheelchair without having to carry it.

Question 14. The Access Board is aware that, in practice, unoccupied onboard wheelchairs are sometimes carried by an attendant as opposed to being pushed on their own wheels. Should the onboard wheelchair be required to be maneuverable on its own wheels when unoccupied?

The onboard wheelchair must be collapsible for stowage in one of the spaces certified by the FAA for stowage of onboard wheelchairs (such as a closet or overhead luggage compartment).

Question 15. What are the FAA-certified stowage spaces on commercial passenger aircraft with over 125 passenger seats, and what are their respective dimensions?

Question 16. Would these proposed technical specifications result in an onboard wheelchair that will fit in at least one of the FAA-certified spaces for onboard wheelchair stowage? If not, how should the specifications be altered so that the onboard wheelchair will fit into such spaces?

This provision requires the onboard wheelchair to be stable throughout transport and transfer of the occupant. The purpose of this provision is to ensure that the onboard wheelchair will not tip or fall in any direction during use, which could result in injury to the occupant, attendant, or other passengers.

Question 17. What are the stability concerns regarding existing onboard wheelchair models?

Question 18. Would a design for over-toilet positioning affect the stability of the onboard wheelchair? Please explain.

Question 19. What additional requirements, if any, could be provided to ensure that the onboard wheelchair is stable during use?

The purpose of this provision is to reduce the risk of injury by requiring that the onboard wheelchair be free from sharp or abrasive components and have eased edges. Sharp edges or abrasive elements may cause a direct contact injury or result in an occupant or attendant losing his or her grip during positioning or transfer.

In order to ensure the proper operation of the onboard wheelchair, the operation instructions must be prominently displayed. Providing instructions on the onboard wheelchair itself will ensure that any attendant using it will have access to the instructions and understand its proper operation.

For ease of transfer, the seat height of the onboard wheelchair should be as close to the height of the aircraft seat as possible to permit lateral transfer. See The Impact of Transfer Setup on the Performance of Independent Transfers: Final Report, https://www.herl.pitt.edu/ab/. The Access Board seeks information on aircraft passenger seat heights and aircraft toilet heights. In the Board's Americans with Disabilities Act (ADA) Accessibility Guidelines for Buildings and Facilities, 36 CFR part 1191, and ADA Accessibility Guidelines for Transportation Vehicles, 36 CFR part 1192, we have routinely required a fixed height of 17 to 19 inches for transfer surfaces (See e.g., 36 CFR 1191, Appendix D, 604.4 (toilet seat), 610.2 (bathtub seats), 610.3 (shower compartment seats), and 903.5 (benches) and 36 CFR 1192.107 and 1192.123 (toilet seat in commuter and intercity rail cars). We are unable to propose a seat height without further information regarding the height of passenger seats and the height of aircraft toilets. 6

Question 20. What is the height of seats on single aisle aircraft with more than 125 passenger seats? Please provide the airline, the type of aircraft, class of seating (if there is a difference among classes), and the height of the seats measured from the floor to the uncompressed top of the cushion or padding.

Question 21. Please provide the following dimensions of the height of aircraft toilets: Height of the bowl measured from the floor; height of the toilet seat measured from the rim of the bowl; and height of the closed toilet seat lid measured from the surface upon which it sits.

Question 22. What are the design and engineering considerations of an onboard wheelchair with an adjustable seat height?

The seat size of the onboard wheelchair is restricted by the width of the aircraft aisle and the doorway opening of the aircraft lavatory. The purpose of this provision is to provide access to the largest number of individuals with disabilities, while also ensuring the onboard wheelchair can function as intended. We propose a seat size of at least 15 inches wide and at least 16 inches deep. These dimensions are consistent with the size required in our Guidelines for Aircraft Boarding Chairs. See https://www.access-board.gov/research/completed-research/guidelines-for-aircraft-boarding-chairs 1987. In that technical paper, we opined that the “narrowest part of the aircraft aisle is generally at the aircraft seat armrest” and is 17 inches. Id. at 22. Additionally, we referenced Wesley Woodson's 1981 Human Factors Design Handbook, which noted that the 95th percentile male seat width was 15.9 inches. Id. Based on both the confines of the aircraft dimensions and human factors, we have determined that 15 inches wide is still a valid width requirement for the onboard wheelchair. Additionally, the Board is proposing that the onboard wheelchair seat be padded or cushioned to preserve skin integrity, minimize injury, prevent spasticity, and provide greater safety and comfort.

Question 23. What recent human factors research provides data on seated hip breadth for the 95th percentile male?

Question 24. On single-aisle aircraft with more than 125 passenger seats, is there any part of the aircraft aisle that is narrower than 17 inches through which the onboard wheelchair would need to pass to transport a passenger from her seat to the lavatory?

Question 25. What are the cost implications, if any, of the proposed seat size?

In determining the proposed height for the onboard wheelchair's back support, we looked to the current Department of Transportation Federal Aviation Administration Human Factors Design Standard, which indicates that the 95th percentile male for shoulder sitting height is 25.4 inches and the shoulder sitting height for a 5th percentile female is 20 inches. HF-STD001B (Dec. 30, 2016). These measurements reveal an increase in shoulder height from the dimensions used in the Access Board's 1987 Guidelines for Boarding Chairs, which recommended a minimum back support height of 25 inches. 7 Based on this updated anthropometric information, we are proposing that the onboard wheelchair back support be a minimum of 26 inches high above the seat. In addition, we are proposing to allow a gap of no more than 2 inches between the surface of the seat and the bottom of the back support. The purpose of this specification is to ensure that the backrest is positioned low enough to provide support to the occupant, while allowing manufacturing flexibility needed to ensure that the chair can be folded for stowage.

Question 26. Is a two-inch gap between the seat and the back support sufficiently large to allow the chair to be folded?

Question 27. It is important that the onboard wheelchair provide sufficient trunk support to the occupant. Should these guidelines specify a minimum width for the back support? If so, what should the recommended width be?

Question 28. Should these guidelines specify a requirement for head and neck support? What are the design implications of adding head and neck support? Would the onboard wheelchair's functionality be affected?

The Board proposes a requirement of two repositionable arm supports. The purpose of the arm supports on the onboard wheelchair is to provide transfer support to persons using the onboard wheelchair and to allow occupants seated in the chair to reposition themselves. In addition, the arm supports allow onboard wheelchair occupants to stabilize themselves during transport. While both arm supports may be used simultaneously for transfer into and out of the front of the onboard wheelchair, a side transfer from or to an aircraft seat will require the repositioning of one of the arm supports. For example, if the occupant is transferring into the onboard wheelchair from the left side of the chair, the arm support on the left side of the chair would be repositioned so as not to obstruct the transfer and the occupant would use the arm support on the right side to assist with transfer.

The proposed length of these supports is 15 inches. The proposed length is based on anthropometrics of elbow-grip length, which is the horizontal distance from the back of the elbow to the center of the clenched fist: 15.4 inches for 95th percentile males and 11.8 inches for 5th percentile females. Department of Transportation Federal Aviation Administration Human Factors Design Standard, HF-STD-001B, 5.12.3.2.1.23 (Dec. 30, 2016).

Question 29. Should these guidelines specify a width and shape for the armrests in order to achieve the purpose of this provision? If so, what armrest width and shape would be optimal to provide support during transfer and repositioning?

The purpose of the foot support is to provide support and stability for the occupant's feet and legs during transport, as well as to assist the occupant with repositioning and transferring. In determining the appropriate size of the foot support, we considered anthropometric data of the human foot size. As noted above, we were unable to locate recent anthropometric data on feet, and thus relied on data from Wesley Woodson's 1981 Human Factors Design Handbook, which we referenced in our Guidelines for Aircraft Boarding Chairs (1987). This research indicates a foot breadth of 4.3 inches and foot length of 11.2 inches for 95th percentile males and a foot breadth of 3.2 inches and foot length of 8.7 inches for 5th percentile females. Based on this information, and taking into consideration additional space for footwear, the Access Board proposes a unitary foot support that is a minimum of 9 inches wide and 12 inches deep. The unitary support allows for more stability as both feet move together. Further, the unitary support design requires fewer moving parts. Finally, the foot support must be repositionable so as not to obstruct transfer to or from the side or front of the onboard wheelchair.

Question 30. Is the proposed size of the foot support sufficient to provide a stable support for both feet?

Question 31. Do the proposed design, size, and repositionability of the foot support present any design or engineering concerns? Please describe those concerns, if any.

Question 32. Should the footrest fold in a specific direction, such as up or off to one side? If so, what direction should be specified and why?

The Access Board proposes that the bottom of the foot support be at least 0.75 inches higher than the highest point of the lavatory doorway threshold. The purpose of this provision is to ensure that the onboard wheelchair can easily and safely maneuver over the lavatory threshold to enter the lavatory in both a forward and backward approach.

Question 33. Are there any other barriers besides the lavatory threshold that would require the foot support to clear a specific height?

The Board proposes that onboard wheelchairs have independent caster wheels for maximum maneuverability in the tight spaces of an aircraft cabin and lavatory. For safety and stability, the Board proposes that each caster provide a swivel lock and a wheel lock. The purpose of the swivel locks is to allow an attendant to lock the wheels in position for linear movement, providing greater stability and directional control as the attendant pushes the chair down the aisle. The wheel locks ensure the onboard wheelchair can be secured in a static position for transfer or for use inside the lavatory.

Question 34. Should these guidelines specify a size of the caster wheels? If so, what size wheel would ensure stability of the onboard wheelchair and allow the chair to easily traverse the lavatory doorway threshold?

Question 35. What would be the cost implications of a requirement that the caster wheels have a five-inch diameter?

Question 36. Is it necessary for safety and stability that each caster have a swivel lock? Would swivel locks on two wheels be sufficient? Please explain.

Question 37. Please explain the design and engineering considerations involved in the provision of a wheel lock system that engages each caster wheel. What are the safety concerns with a chair that has locks on only two caster wheels?

Question 38. What are the engineering and design implications of a requirement for the swivel and wheel locks to be operable by the occupant?

Question 39. What effect on stability, if any, results from a requirement that all wheels be independent casters?

Question 40. Is it necessary for maneuverability that each wheel of the onboard wheelchair be an independent caster? Could an onboard wheelchair easily maneuver through the aisle and into the lavatory in both a forward and backward approach with fewer casters? If so, which wheels should be required to be independent casters and why?

The purpose of the rear assist handles is to allow the attendant to push or pull the occupied onboard wheelchair through the aircraft aisle. In addition, the attendant may use the rear assist handles to maneuver the onboard wheelchair into the lavatory in a forward orientation.

Question 41. Is it necessary for the rear assist handles to be repositionable to allow for over-toilet positioning of the onboard wheelchair?

The purpose of the front assist handles is to allow the attendant to maneuver the occupied onboard wheelchair into the lavatory in a backward approach, position the onboard wheelchair over the toilet, and maneuver the onboard wheelchair out of the lavatory. The front assist handles must be capable of being repositioned so as not to obstruct transfer. The Board envisions that these assist handles would be attached to the onboard wheelchair at seat or knee height, similar to the design of some current models of aircraft boarding chairs.

Question 42. Are there any existing onboard wheelchairs that have front assist handles? If so, where are the assist handles located?

Question 43. Are there any engineering or design concerns regarding front assist handles?

This provision requires that the onboard wheelchair be equipped with both torso and leg restraints. The torso restraints are intended to secure the upper and lower torso of the occupant in the onboard wheelchair and the leg restraints are intended to maintain the legs of the occupant in the correct position during transport. The purpose of these restraints is to keep the occupant securely seated in the chair and prevent injury during transport through the aircraft. These restraints must be designed such that they can be repositioned so as not to obstruct transfer of the occupant to or from the onboard wheelchair. The fastening mechanisms of the restraints must be operable by the occupant so that the occupant may fasten the restraints unassisted if desired. Finally, the restraints must be durable. The Access Board is aware of durability issues related to certain types of fasteners, such as hook-and-loop strip fasteners. The Board seeks comment on whether a specific type of fastener should be specified (or prohibited) by these guidelines.

Question 44. Are additional restraints needed to ensure safe use of the onboard wheelchair?

Question 45. Is it feasible to provide retractable restraints that auto-adjust (similar to the retractable seatbelts in cars)?

Question 46. Should specific types of fasteners be required or prohibited to ensure durability?

For the reasons stated in this notice, the Board proposes Advisory Guidelines for Aircraft Onboard Wheelchairs as follows:

101.1 Purpose. These recommended specifications for onboard wheelchairs are intended to improve accessibility of a non-accessible lavatory on a single-aisle aircraft with more than 125 passenger seats by improving the functionality and usability of onboard wheelchairs.

101.2 Voluntary Application. This guidance is not legally binding in its own right. Conformity with this guidance document is voluntary only, and nonconformity will not affect rights and obligations under existing statutes and regulations. This guidance provides one example of carriers might satisfy performance standards for onboard wheelchairs on covered aircraft.

101.3 Dimensions. These technical specifications are based on adult dimensions and anthropometrics.

101.4 Dimensional Tolerances. All dimensions are subject to conventional industry tolerances for manufacturing processes, material properties, and field conditions.

101.5 Units of Measurement. Measurements are stated in U.S. customary and metric units. The values stated in each system (U.S. customary and metric units) may not be exact equivalents, and each system should be able to be used independently of the other.

102.1 Defined Terms. For the purpose of this document, the following terms have the indicated meaning.

Attendant. An individual who is assisting the occupant in using or operating the onboard wheelchair.

Caster. A wheel on a swivel assembly permitting the wheel to freely turn around its vertical axis.

Onboard Wheelchair. A wheelchair that is used to transport a person with a mobility disability between an aircraft seat and an aircraft lavatory.

102.2 Other Defined Terms. Terms defined in regulations issued by the Department of Transportation to implement the Air Carrier Access Act (14 CFR 382) and not defined in 102.1, shall have the meaning as defined in the Department of Transportation's regulations.

102.3 Undefined Terms. Any term not defined in 102.1 or in the Department of Transportation's regulations shall be given its ordinarily accepted meaning in the sense that the context implies.

102.4 Interchangeability. Words, terms, and phrases used in the singular include the plural and those used in the plural include the singular.

201 Maneuverability. The onboard wheelchair must be maneuverable by an attendant on the aircraft.

201.1 Occupied Movement. The onboard wheelchair shall be designed to be moved both forward and backward through the aircraft aisle by an attendant.

201.1.1 Lavatory Transfer. The onboard wheelchair shall be designed to be maneuvered in a forward orientation partially into at least one aircraft lavatory to permit transfer from the onboard wheelchair to the toilet.

201.1.2 Over-Toilet Positioning. Onboard wheelchairs shall be designed to be maneuvered in a backward orientation to permit positioning over the closed toilet without protruding into the clear space needed to completely close the lavatory door, unless the lavatory already permits the occupant of the onboard wheelchair to enter, close the door, and independently transfer from the onboard wheelchair to the toilet.

201.2 Unoccupied Movement. When folded, the onboard wheelchair shall be capable of being moved on its own wheels.

202 Stowage. Onboard wheelchairs shall fit within at least one of the available certified onboard wheelchair stowage spaces consistent with weight and space limits applicable to each carrier's aircraft models.

203 Stability. When occupied for use, the onboard wheelchair shall not tip or fall in any direction under normal operating conditions, including when the swivel locks on the casters are engaged or when the wheel locks are applied.

204 Surface Hazards. The onboard wheelchair shall be free of sharp or abrasive components and shall have eased edges.

205 Instructions. The onboard wheelchair shall prominently display instructions for proper operation and stowage.

206 Seat. Onboard wheelchairs shall provide a seat that meets the following specifications:

206.1 Height. The top of the seat of the onboard wheelchair when uncompressed shall align with the height of the top of an aircraft seat when uncompressed to the maximum extent practicable.

206.2 Size. The surface of the seat shall be 15 inches (381 mm) wide minimum and 16 inches (406 mm) deep minimum.

206.3 Padding. The seat shall be a solid surface that is padded or cushioned.

206.4 Load. [Reserved.]

207 Back Support. Onboard wheelchairs shall provide a back support that meets the following recommended specifications:

207.1 Size. The back support shall extend from a point 2 inches (51 mm) maximum above the surface of the seat to a point 26 inches (660 mm) minimum above the surface of the seat.

207.2 Padding. The backrest shall be padded or cushioned.

207.3 Load. [Reserved.]

208 Arm Supports. Onboard wheelchairs shall provide two arm supports that meet the following recommended specifications:

208.1 Length . Arm supports shall have a length of 15 inches (381 mm) minimum.

208.2 Positions and Securement. Arm supports shall be repositionable so as not to obstruct transfer of the occupant to or from the seat of the onboard wheelchair. Arm supports shall be secure in their fittings when in place for transfer.

208.3 Load. [Reserved.]

209 Foot Support. Onboard wheelchairs shall provide foot support that meets the following recommended specifications:

209.1 Size. The foot support shall be unitary and shall be 9 inches (229 mm) wide minimum and 12 inches (305 mm) deep minimum.

209.2 Positions and Securement. The foot support shall be repositionable so as not to obstruct transfer of the occupant to or from the seat of the onboard wheelchair. Foot supports shall be secure in their fittings when in place for transfer.

209.3 Threshold Clearance. When the onboard wheelchair is unoccupied, the underside of the foot support shall clear the highest point of the lavatory door threshold by 0.75 inches (19 mm) minimum.

209.4 Load. [Reserved.]

210 Casters. Onboard wheelchairs shall provide independent casters that meet the following recommended specifications:

210.1 Swivel Locks. Each caster shall provide a swivel lock that, when engaged, prevents the caster wheel from swiveling on its vertical axis and permits rotation of the wheel only in the direction of travel.

210.2 Wheel Locks. Each caster shall provide wheel locks that, when engaged, prevent rotation of the wheel and permits the onboard wheelchair to be secured in a stationary position.

210.3emsp;Load. [Reserved.]

211 Assist Handles. Onboard wheelchairs shall provide assist handles that meet the following recommended specifications:

211.1 Rear Assist Handles. At least two assist handles shall be provided on the rear of the onboard wheelchair.

211.2 Front Assist Handles. At least two assist handles shall be provided on the front of the onboard wheelchair. The assist handles shall be capable of being repositioned so as not to obstruct transfer of the occupant to or from the onboard wheelchair.

211.3 Load. [Reserved.]

212 Restraints. Onboard wheelchairs shall provide functioning torso restraints and leg restraints that meet the following recommended specifications:

212.1 Torso Restraints. Torso restraints shall secure the upper and lower torso of the occupant of the onboard wheelchair so as to prevent the occupant from falling out of the onboard wheelchair during transport.

212.2 Leg Restraints. Leg restraints shall maintain the legs of the occupant in position during transport.

212.3 Fastening Mechanisms. Fastening mechanisms for restraints shall be durable and operable by the occupant.

212.4 Positions. Restraints and their attachments shall be capable of being repositioned so as not to obstruct transfer of the occupant to or from the seat of the onboard wheelchair.

Public Call Information: Dial: 800-353-6461; Conference ID: 8263473.

This meeting is available to the public through the following toll-free call-in number: 800-353-6461, conference ID number: 8263473. Any interested member of the public may call this number and listen to the meeting. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with the conference call number and conference ID number.

Members of the public are entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be mailed to the Western Regional Office, U.S. Commission on Civil Rights, 300 North Los Angeles Street, Suite 2010, Los Angeles, CA 90012. They may be faxed to the Commission at (213) 894-0508, or emailed Ana Victoria Fortes at afortes@usccr.gov. Persons who desire additional information may contact the Regional Programs Unit at (213) 894-3437.

Records and documents discussed during the meeting will be available for public viewing prior to and after the meetings at https://www.facadatabase.gov/FACA/FACAPublicViewCommitteeDetails?id=a10t0000001gzliAAA.

Please click on “Committee Meetings” tab. Records generated from these meetings may also be inspected and reproduced at the Regional Programs Unit, as they become available, both before and after the meetings. Persons interested in the work of this Committee are directed to the Commission's website, https://www.usccr.gov, or may contact the Regional Programs Unit at the above email or street address.

Public Call Information: Dial: 800-367-2403; Conference ID: 1709830.

This meeting is available to the public through the following toll-free call-in number: 800-367-2403, conference ID number: 1709830. Any interested member of the public may call this number and listen to the meeting. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with the conference call number and conference ID number.

Members of the public are entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be mailed to the Western Regional Office, U.S. Commission on Civil Rights, 300 North Los Angeles Street, Suite 2010, Los Angeles, CA 90012. They may be faxed to the Commission at (213) 894-0508, or emailed Ana Victoria Fortes at afortes@usccr.gov. Persons who desire additional information may contact the Regional Programs Unit at (213) 894-3437.

Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at https://www.facadatabase.gov/FACA/FACAPublicViewCommitteeDetails?id=a10t0000001gzkUAAQ.

Please click on “Committee Meetings” tab. Records generated from this meeting may also be inspected and reproduced at the Regional Programs Unit, as they become available, both before and after the meeting. Persons interested in the work of this Committee are directed to the Commission's website, https://www.usccr.gov, or may contact the Regional Programs Unit at the above email or street address.

Exceptional Circumstance: Pursuant to 41 CFR 102-3.150, the notice for this meeting is given less than 15 calendar days prior to the meeting because of the exceptional circumstances of recovery from the government shutdown.

The Commercial Fisheries Research Foundation (CFRF) submitted a complete application for an EFP on June 12, 2019, for a 2019 Scallop Research Set-Aside (RSA) project titled “Piloting a Novel Dredge Type to Reduce Bycatch and Improve Fuel Efficiency in the Southern New England Scallop Fishery.” This project was funded under the 2019 Atlantic Sea Scallop RSA Program. Researchers expect to start the first trip for this project as soon as the EFP is issued. This project would look at how the modified dredge (the N-Viro dredge), a new gear type in the scallop fishery, would reduce bycatch, minimize habitat impacts by minimizing dredge penetration into and resistance along the seafloor, and improve fuel efficiency by towing at lower speeds.

Participating vessels would conduct scallop dredging for 12 months from date of issue. The study would use both limited access general category (LAGC) and limited access (LA) vessels. The LA component would consist of one 5-day trip conducting 80 total paired tows with the N-Viro dredge. The N-Viro dredge is a 15-ft (4.57-m) tow bar fitted with five smaller dredges connected to the tow bar. Each smaller dredge is 2 ft (0.61 m) wide with a 10-in (25.4-cm) twine top and 4 rows of rings in the apron. Additionally each smaller dredge would be outfitted with a turtle chain mat. The project would conduct 40 of the 80 tows with the turtle deflector dredge control dredge west of 71° W longitude and the remaining 40 tows with the standard New Bedford style control dredge east of 71° W longitude.

The LAGC component of the project would use three LAGC vessels that would complete a total of 30 research days-at-sea (DAS). Each vessel would complete 10 DAS, with 5 days devoted to fishing with the N-viro dredge and 5 days devoted to carrying either a New Bedford or Provincetown style control dredge. Each LAGC vessel would tow an N-viro dredge that has a 10-ft (3.05-m) tow bar with three smaller dredges connected to it. The construction of each smaller dredge for the LAGC component is identical to the LA component. The LAGC fleet would utilize either a Provincetown or New Bedford style dredge common in the fishery as a control dredge.

All tows for both LA and LAGC vessels would be 10 minutes at varying depths and substrates. Tow time may be adjusted as needed based on dredge performance. For all tows, the entire sea scallop catch would be counted into baskets and weighed. All finfish catch would be sorted by species and then counted and measured. With the exception of samples retained for further processing for scientific purposes, no catch would be retained for longer than needed to conduct sampling, and no catch would be landed for sale on the LA trip. On LAGC trips, scallop and monkfish catch would be kept for sale in accordance with current regulations, but all other catch will be handled in the same manner as the LA research trip.

CFRF needs these exemptions to allow them to conduct experimental dredge towing without being charged DAS. Participating vessels need crew size waivers to accommodate science personnel. Exemptions are also needed from the turtle deflector dredge requirements for testing of an experimental dredge that has a slightly different configuration that the current gear requirements. Possession waivers would enable researchers to sample finfish catch that exceeds possession limits or prohibitions. The project would be exempt from the sea scallop observer program requirements because activities conducted on the trip are not consistent with normal fishing operations. Researchers from CFRF will accompany each trip taken under the EFP.

If approved, the applicant may request minor modifications and extensions to the EFP throughout the year. EFP modifications and extensions may be granted without further notice if they are deemed essential to facilitate completion of the proposed research and have minimal impacts that do not change the scope or impact of the initially approved EFP request. Any fishing activity conducted outside the scope of the exempted fishing activity would be prohibited.

The NOAA Science Advisory Board (SAB) was established by a Decision Memorandum dated September 25, 1997, and is the only Federal Advisory Committee with responsibility to advise the Under Secretary of Commerce for Oceans and Atmosphere on strategies for research, education, and application of science to operations and information services. SAB activities and advice provide necessary input to ensure that National Oceanic and Atmospheric Administration (NOAA) science programs are of the highest quality and provide optimal support to resource management.

Status: The meeting will be open to public participation with a 10-minute public comment period at 11:50 a.m.-11:55 a.m. EST. The SAB expects that public statements presented at its meetings will not be repetitive of previously submitted verbal or written statements. In general, each individual or group making a verbal presentation will be limited to a total time of two (2) minutes. Written comments for the meeting should be received in the SAB Executive Director's Office by August 26, 2019 to provide sufficient time for SAB review. Written comments received after by the SAB Executive Director after these dates will be distributed to the SAB, but may not be reviewed prior to the meeting date.

Special Accommodations: These meetings are physically accessible to people with disabilities. Requests for special accommodations may be directed no later than 12:00 p.m. on August 26, 2019, to Dr. Cynthia Decker, SAB Executive Director, SSMC3, Room 11230, 1315 East-West Highway, Silver Spring, MD 20910; Email: Cynthia.Decker@noaa.gov.

Matters To Be Considered: The meeting will include a discussion of the recommendations from the SAB Environmental Information Services Working Group regarding the Environmental Prediction Innovation Center (EPIC). The Meeting materials, including work products will be made available on the SAB website: http://sab.noaa.gov/SABMeetings.aspx.

DSBG fishing trials have occurred for the past eight years (2011-2015, research years; 2015-2019, EFP years) in the U.S. West Coast Exclusive Economic Zone (EEZ) off California. Data collected from these fishing activities have demonstrated DSBG to achieve about a 95 percent marketable catch composition (swordfish, opah, tunas, and sharks). Non-marketable species catch rates have remained low and most non-marketable catch are released alive. Due to DSBG being actively tended, strikes are detected within minutes of a catch on the line. As a result, all catches can be tended quickly, with catch brought onboard the vessel in good condition.

To date, DSBG has had four interactions with protected species. Three interactions were with elephant seals, which were not seriously injured and were released alive due to the strike detection and quick tending of the gear. These species are protected by the Marine Mammal Protection Act, but are not listed as threatened or endangered under the Endangered Species Act (ESA).

On August 4, 2018, a loggerhead sea turtle was observed entangled in the surface buoy lines of a vessel fishing under an EFP to test standard DSBG. The sea turtle was brought on board, disentangled, and released back to the sea in a lively, uninjured condition. Based on analysis of the incident, NMFS West Coast Region amended the applicable Terms and Conditions to require the following attributes, to minimize the likelihood of future sea turtle entanglements:

1. The surface buoy flotation and strike detection array must be a streamlined inline configuration, with no loops or hanging material, and no more than 6 feet between adjacent buoys, to reduce entanglement potential.

2. The surface buoy flotation and strike detection array must consist of a >40lb flotation non-compressible hard ball, a minimum six pound flotation inline-float, and a sub-surface inline-float, all connected in-line with a minimum of 3/8 inch diameter line, and no more than six feet between adjacent buoys.

3. Use of buoy tether attachments ( e.g., non-streamlined gear with loops, nooks, and dangling components) is prohibited.

DSLBG trials have occurred since 2015 and have produced similar results to standard DSBG activities. Swordfish and other marketable species have represented about 97 percent of the catch with very similar catch composition to DSBG. Non-marketable species are released alive due to quick DSLBG strike detection and active gear tending. To date, there have been no protected species interactions with DSLBG in either EFP fishing or research trials.

At the June 2019 Pacific Fishery Management Council (Council) meeting, the Council received a total of seventeen additional EFP applications for review. Based on recommendations from the Council's HMS Management Team, the Council recommended that NMFS consider issuing EFPs to authorize use of DSBG and/or DSLBG for sixteen of the applications (see Table)

In addition, one application for one vessel to fish modified linked buoy gear at night, was preliminarily approved by the Council, with a final recommendation scheduled for the September 2019 Council meeting. The gear configuration in this application differs from previously approved EFPs in that the applicants propose fishing at night, at a depth of around 300 feet. The array of surface buoys has also been modified to include a green light to aid in the monitoring, strike detection, and retrieval of gear at night. At previous Council meetings, the Pfleger Institute of Environmental Research (PIER) included a brief summary of DSBG gear trials conducted at night. These sets were fished at a depth of less than 100 ft and resulted in a large proportion of blue shark catch. Due to this high rate of interactions with blue sharks, PIER ceased night fishing with DSBG. Mr. Perez and Mr. Carson believe that fishing at a greater depth at night will increase catch of marketable species, including swordfish during their diurnal migration to and from depth, while greatly reducing the occurrence of non-marketable species interactions. The Council's HMS Management Team (HMSMT) agreed ( https://www.pcouncil.org/wp-content/uploads/2019/06/J5a_Sup_HMSMT_Rpt1_JUN2019BB.pdf ) that this theory is worth allowing a single vessel, operated by a fisherman with several years of DSBG fishing experience under both PIER and his own EFP, to test this new approach.

All applications are available at the Council June 2019 meeting briefing book website, under agenda item J.5: https://www.pcouncil.org/resources/archives/briefing-books/june-2019-briefing-book/#hmsJun2019.

The Council also recommended that NMFS prioritize issuance of these June 2019 EFP applications over previously-approved EFP applications that have not yet been issued, that NMFS extend currently issued DSBG EFPs through 2020, and that NMFS consider any EFP applications previously approved by the Council but not issued by December 31, 2019, due to inaction or abandoned by the applicant, as ineligible for issuance.

NMFS is requesting public comment on the seventeen DSBG/DSLBG EFP applications recommended for consideration by the Council. If all applications are approved, the EFPs would allow up to eighteen vessels to fish with DSBG, four vessels to fish with DSLBG, and one vessel to fish modified linked buoy gear at night, in the U.S. West Coast EEZ. Aside from the exemption described above, vessels fishing under an EFP would be subject to all HMS FMP requirements implemented in NMFS regulations at 50 CFR 660, including measures to protect sea turtles, marine mammals, and seabirds. For up-to-date information on HMS EFPs, please visit NMFS West Coast Region's “Highly Migratory Species—Exempted Fishing Permits” web page: https://www.fisheries.noaa.gov/west-coast/sustainable-fisheries/highly-migratory-species-exempted-fishing-permits.

NMFS will consider all public comments submitted in response to this Federal Register Notice prior to issuance of any EFP. Additionally, NMFS will analyze the effects of issuing EFPs in accordance with the National Environmental Policy Act and NOAA's Administrative Order 216-6, as well as compliance with other applicable laws, including Section 7(a)(2) of the ESA (16 U.S.C. 1531 et seq. ), which requires the agency to consider whether the proposed action is likely to jeopardize the continued existence and recovery of any endangered or threatened species or result in the destruction or adverse modification of critical habitat.

Title; Associated Form; and OMB Number: Department of Defense Application for Priority Rating for Production or Construction Equipment; DD Form 691; OMB Control Number 0704-0055.

Needs and Uses: Executive Order 12919 delegates to DoD authority to require certain contracts and orders relating to approved Defense Programs to be accepted and performed on a preferential basis. This program helps contractors acquire industrial equipment in a timely manner, thereby facilitating development and support of weapons systems and other important Defense Programs.

Affected Public: Business or other For-Profit; Not-for-Profit Institutions.

Annual Burden Hours: 610.

Number of Respondents: 610.

Responses per Respondent: 1.

Annual Responses: 610.

Average Burden per Response: 1 hour.

Frequency: On occasion.

Title; Associated Form; and OMB Number: ASSIST Database; OMB Control Number 0704-0188.

Needs and Uses: The Data Item Descriptions in the ASSIST database, formerly the Acquisition Management Systems and Data Requirements Control List (AMSDL), contain data requirements used in Department of Defense (DoD) contracts. The information collected will be used by DoD personnel and other DoD contractors to support the design, test, manufacture, training, operation, and maintenance of procured items, including weapons systems critical to the national defense.

Affected Public: Business or other For-Profit.

Annual Burden Hours: 29,652,480.

Number of Respondents: 1,040.

Responses per Respondent: 432.

Annual Responses: 449,280.

Average Burden per Response: 66 hours.

Frequency: On occasion.

The Data Item Descriptions in the ASSIST database, formerly the AMSDL, is a collection of data requirements used in Department of Defense contracts. Information collection requests are contained in DoD contract actions for supplies, services, hardware, and software. This information is collected and used by DoD and its component Military Departments and Agencies to support the design, test, manufacture, training, operation, maintenance, and logistical support of procured items, including weapons systems. The collection of such data is essential to accomplishing the assigned mission of the Department of Defense. Failure to collect this information would have a detrimental effect on the DoD acquisition programs and National Security. Information used to determine the burden hours is contained in the ASSIST Online database.

Due to circumstances beyond the control of the Department of Defense (DoD) and the Designated Federal Officer, the Threat Reduction Advisory Committee was unable to provide public notification required by 41 CFR 102-3.150(a) concerning the August 26, 2019 meeting of the Threat Reduction Advisory Committee. Accordingly, the Advisory Committee Management Officer for the Department of Defense, pursuant to 41 CFR 102-3.150(b), waives the 15-calendar day notification requirement. This meeting is being held under the provisions of the Federal Advisory Committee Act (FACA) (5 U.S.C., App.), the Government in the Sunshine Act (5 U.S.C. 552b), and 41 CFR 102-3.140 and 102-3.150.

Purpose of the Meeting: The TRAC will conduct SECRET and higher-level discussions and deliberations on the continued viability of the Chemical Weapons Convention and Biological Weapons Convention, in as far as current international agreements on chemical and biological weapons and the implementation and enforcement of those treaties. Also the consideration of analytic and data-driven frameworks for the evaluation of the current strategic nuclear environment and the assessment of emergent challenges to the U.S. ability to deter threats from peer and near-peer competitors; and providing independent, executive-level advice and recommendations in support of Special Operations Command (SOCOM) efforts as the DoD coordinating authority for countering weapons of mass destruction.

Agenda: Threat Reduction Advisory Committee Plenary Location: Pentagon, Room 3A912A—All discussions will be conducted at or above the Secret classification level.—August 26, 2019, Designated Federal Officer Remarks from Mr. Polchek followed by opening remarks from the Chair, Ambassador Lehman on how he expects the deliberations and recommendation process to occur. The TRAC will then hold classified discussions and final deliberations on all Subcommittee work. After a short lunch break, the TRAC will resume discussion and final deliberations on all Subcommittee recommendations. The TRAC chair and subcommittee leads will then brief their classified recommendations to Under Secretary of Defense for Acquisition and Sustainment (USD (A&S)) Ms. Ellen M. Lord. After providing their recommendations, Ms. Lord will provide instructions for future studies. After USD Lord departs, the TRAC will begin classified discussion of Ms. Lord's instructions and comments. Following the discussions, AMB Lehman will provide a summary of the day, and adjourn the meeting.

Meeting Accessibility: Pursuant to section 10(d) of the FACA, 5 U.S.C. 552b(c), and 41 CFR 102-3.155, the DoD has determined that the meeting shall be closed to the public. The Under Secretary of Defense for Acquisition and Sustainment, in consultation with the DoD FACA Attorney, has determined in writing that all sessions of this meeting are required to be closed to the public because the discussions will contain classified information and matters covered by 5 U.S.C. 552b(c)(1). Such classified matters are inextricably intertwined with the unclassified material and cannot reasonably be segregated into separate discussions without disclosing secret-level or higher material.

Written Statements: Pursuant to section 10(a)(3) of FACA and 41 CFR 102-3.105(j) and 102-3.140, the public or interested organizations may submit written statements to the membership of the TRAC at any time or in response to the stated agenda of a planned meeting. Written statements should be submitted to the TRAC's Designated Federal Officer. The Designated Federal Officer's contact information is listed in this notice, or it can be obtained from the General Services Administration's FACA Database: http://www.facadatabase.gov/committee/committee.aspx?cid=1663&aid=41. Written statements that do not pertain to a scheduled meeting of the TRAC may be submitted at any time. However, if individual comments pertain to a specific topic being discussed at a planned meeting, then these statements must be submitted no later than five business days prior to the meeting in question. The Designated Federal Officer will review all submitted written statements and provide copies to all TRAC members.

Title; Associated Form; and OMB Number: DLA Climate Culture Survey; OMB Control Number 0704-0575.

Needs and Uses: The information collection requirement is necessary to obtain and record the perceptions of DLA employees regarding the organizational culture and climate. The DLA Culture/Climate Survey standardizes how organizational culture/climate is measured across the DLA enterprise, focuses leadership attention on culture/climate, and drives actions to improve the overall culture/climate and DLA organizational performance.

Affected Public: Individuals or Households.

Annual Burden Hours: 645.

Number of Respondents: 860.

Responses per Respondent: 1.

Annual Responses: 860.

Average Burden per Response: 45 minutes.

Frequency: Biennially.

Respondents are Foreign Nationals employed by DLA (and thereby considered members of the public). The DLA Culture/Climate Survey provides a confidential mechanism for employees to share feedback on their work environment, resulting in opportunities for DLA employees and leaders to engage in thoughtful, data-driven discussions that lead to informed action and improve the DLA collective performance.

Title; Associated Form; and OMB Number: MHS GENESIS Patient Registration Module & Patient Portal; OMB Control Number 0720-XXXX.

Type of Request: New.

Number of Respondents: 2,870,338.

Responses per Respondent: 1.

Annual Responses: 2,870,338.

Average Burden per Response: 7 minutes.

Annual Burden Hours: 334,872.8.

Needs and Uses: The information collection requirement is necessary to provide and document medical care; determine eligibility for benefits and entitlements; adjudicate claims; determine whether a third party is responsible for the cost of MHS provided healthcare and recover that cost; and evaluate fitness for duty and medical concerns which may have resulted from an occupational or environmental hazard. Obtaining this information is essential for the Department of Defense (DoD) to provide medical care and recover costs.

Affected Public: Individuals or households.

Frequency: As required.

Respondent's Obligation: Voluntary.

OMB Desk Officer: Mr. Josh Brammer.

You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

Instructions: All submissions received must include the agency name, Docket ID number, and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

DOD Clearance Officer: Ms. Angela James.

Requests for copies of the information collection proposal should be sent to Ms. James at whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil.

The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

Title of Collection: Pell for Students who are Incarcerated Experimental Site Initiative.

OMB Control Number: 1845-0139.

Type of Review: A reinstatement of a previously approved information collection.

Respondents/Affected Public: State, Local, and Tribal Governments; Private Sector.

Total Estimated Number of Annual Responses: 170.

Total Estimated Number of Annual Burden Hours: 12,750.

Abstract: Through the Pell for Students who are Incarcerated experiment (also known as Second Chance Pell) the Department of Education will provide selected eligible postsecondary institutions with a waiver to the current statutory ban on incarcerated individuals, who are otherwise eligible, from receiving Federal Pell Grant funds to attend eligible postsecondary programs. The experiment aims to test whether participation in high-quality educational opportunities increases after access to financial aid for incarcerated adults is expanded and to examine how waiving the restriction influences individual academic and life outcomes. This is a reinstatement of the information collection instrument that is used by the Department to select qualified institutions.

Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit http://www.epa.gov/dockets.

Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting comments and information to enable it to: (i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (ii) evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval. At that time, EPA will issue another Federal Register notice to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB.

Abstract: Gasoline combustion is a major source of air pollution in most urban areas. In the 1990 amendments to the Clean Air Act (Act), section 211(k), Congress required that gasoline dispensed in nine areas with severe air quality problems, and areas that opt-in, be reformulated to reduce toxic and ozone-forming emissions. (Ozone is also known as smog.) Congress also required that, in the process of producing reformulated gasoline (RFG), dirty components removed in the reformulation process not be “dumped” into the remainder of the country's gasoline, known as conventional gasoline (CG). EPA promulgated regulations at 40 CFR part 80, subpart D—Reformulated Gasoline, subpart E—Anti-Dumping, and subpart F—Attest Engagements, implementing the statutory requirements, which include standards for RFG (80.41) and CG (80.101). The regulations also contain reporting and recordkeeping requirements pertaining to the production, importation, transport and storage of gasoline, in order for the regulated parties to demonstrate compliance and to facilitate compliance oversight and enforcement by the EPA. The program is run by the Compliance Division, Office of Transportation and Air Quality, Office of Air and Radiation. Enforcement is done by the Air Enforcement Division, Office of Regulatory Enforcement, Office of Enforcement and Compliance Assurance. This program excludes California, which has separate requirements for gasoline.

The United States has an annual gasoline consumption of about 135 billion gallons, of which about 30 percent is RFG. In 2017 EPA received reports from 255 refineries, 500 importer facilities/facility groups, 2,068 oxygenate blending facilities, 94 independent laboratory facilities, and the RFG Survey Association, Inc. under this program.

Section 211(k) of the Act requires the Administrator to promulgate regulations establishing requirements for RFG to be used in gasoline-fueled vehicles in the nine specified nonattainment areas, and opt-in areas. The Act specifically provides that recordkeeping, reporting, and sampling and testing requirements are among the tools EPA may use in enforcement of the provisions.

Information claimed as confidential by regulated parties is handled in accordance with EPA Freedom of Information Act regulations at 40 CFR part 2.

Electronic files received by the Agency are stored in a secure data base.

Form numbers: RFG and CG reporting is now required to be completed electronically. The reporting is to be made through the EPA Fuels Programs Reporting Forms which are available on the following website: http://www.epa.gov/otaq/fuels/reporting/index.htm.

Respondents/affected entities: Recordkeeping and, in some cases, reporting are required by the following gasoline marketing-related industries, Standard Industrial Classification (SIC) codes: Refiners (2911), importers (5172), terminals (5171), pipelines (4613), truckers and other distributors (4212), and retailers/wholesale purchaser-consumers (5541). North American Industry Classification System (NAICS) codes: Refiners (324110), pipelines (486910) and terminals (424710). Not all NAICS codes for the responsible reporting parties were found. These are, however, parties which are obligated to report: Importers, truckers and other distributors and retailers/wholesale purchaser-consumers. Some refiners are importers but that is not always the case. Many of the required records are generated and maintained currently in the normal course of business. Without the required records EPA would be unable to enforce the Congressionally-mandated RFG and anti-dumping requirements.

Respondent's obligation to respond: Mandatory per 40 CFR part 80.

Estimated number of respondents: 4,283.

Frequency of response: Quarterly, annually, on occasion.

Total estimated burden: 127,246 hours (per year). Burden is defined at 5 CFR 1320.03(b).

Total estimated cost: $39,473,568 (per year), includes $24,713,032 in none-labor costs.

Changes in estimates: Compared with the ICR currently approved by OMB, there is no change of burden hours. There is an increase in the total burden cost due to the update in labor salaries.

The U.S. Environmental Protection Agency (EPA) plans to create a Privacy Act system of records for certain refrigeration and air-conditioning technician records. The information collected in this system supports the refrigerant management program under Clean Air Act (CAA) section 608 and implementing regulations codified in 40 CFR part 82, subpart F. The regulations establish a certification program for technicians that work on air-conditioning or refrigeration appliances. Instead of directly testing and issuing certifications, EPA approves programs that certify technicians. Certifying programs can voluntarily withdraw when they no longer wish to certify technicians. When a program withdraws its participation, or has its approval revoked or failure to abide by the regulatory requirements, the program must properly dispose of its records by transferring them to another approved technician certification program or to EPA. These records will allow EPA to assist certified technicians in obtaining replacement certification cards.

OMB Control Number: 3060-0706.

Title: Sections 76.952 and 76.990, Cable Act Reform.

Type of Review: Extension a currently approved collection.

Respondents: Business or other for-profit entities; State, Local or Tribal Government.

Number of Respondents and Responses: 70 respondents; 70 responses.

Estimated Time per Response: 1-8 hours.

Frequency of Response: On occasion reporting requirement; Third party disclosure requirement.

Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collection of information is contained in the Telecommunications Act of 1996, Public Law 104-104, Sections 301 and 302, 110 Stat. 56, 114-124.

Total Annual Burden: 210 hours.

Total Annual Cost: None.

Privacy Act Impact Assessment: No impact(s).

Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information.

Needs and Uses: The information collection requirements contained in 47 CFR 76.952 state that all cable operators must provide to the subscribers on monthly bills the name, mailing address and phone number of the franchising authority, unless the franchising authority in writing requests that the cable operator omits such information. The cable operator must also provide subscribers with the FCC community unit identifier for the cable system in their communities. 47 CFR 76.990(b)(1) requires that a small cable operator may certify in writing to its franchise authority at any time that it meets all criteria necessary to qualify as a small operator. Upon request of the local franchising authority, the operator shall identify in writing all of its affiliates that provide cable service, the total subscriber base of itself and each affiliate, and the aggregate gross revenues of its cable and non-cable affiliates. Within 90 days of receiving the original certification, the local franchising authority shall determine whether the operator qualifies for deregulation and shall notify the operator in writing of its decision, although this 90-day period shall be tolled for so long as it takes the operator to respond to a proper request for information by the local franchising authority. An operator may appeal to the Commission a local franchise authority's information request if the operator seeks to challenge the information request as unduly or unreasonably burdensome. If the local franchising authority finds that the operator does not qualify for deregulation, its notice shall state the grounds for that decision. The operator may appeal the local franchising authority's decision to the Commission within 30 days.

OMB Control Number: 3060-XXXX.

Title: Enhanced Geo-Targeted Wireless Emergency Alerts.

Form No.: Not applicable.

Type of Review: New information collection.

Respondents: Individuals or households; State, Local or Tribal Government.

Number of Respondents and Responses: 12,000 respondents and 14,000 responses.

Estimated Time per Response: 0.25 hours.

Frequency of Response: One-time reporting requirement.

Obligation to Respond: Voluntary. Statutory authority for this information collection is authorized under the Warning, Alert and Response Network Act, Title VI of the Security and Accountability for Every Port Act of 2006 (120 Stat. 1884, section 602(a), codified at 47 U.S.C. 1201, et seq., 1202(a)) (WARN Act) and 47 U.S.C. 151, 154(i), 154(j), 154(o), 218, 219, 230, 256, 301, 302(a), 303(f), 303(g), 303(j), 303(r) and 403.

Total Annual Burden: 3,500 hours.

Total Annual Costs: No Cost.

Privacy Act Impact Assessment: Yes. The FCC is revising the Privacy Impact Assessment (PIA) and modifying the existing System of Records Notice (SORN), FCC/PSHSB-1, FCC Emergency and Continuity Contacts System (ECCS), for the Public Safety Support System to address the personally identifiable information (PII) that will be collected, used, and stored as part of the information collection requirements.

Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information.

Needs and Uses: The WARN Act gives the Commission authority to adopt relevant technical standards, protocols, procedures and other technical requirements governing Wireless Emergency Alerts (WEA). The Commission adopted rules to implement the WEA system (previously known as the Commercial Mobile Service Alert System) pursuant to the WARN Act to satisfy the Commission's mandate to promote the safety of life and property through the use of wire and radio communication. The WEA system transmits emergency alerts to WEA-capable mobile devices, providing consumers with timely warnings and information in emergencies. In 2018, the Commission issued a Report & Order requiring that Participating Commercial Mobile Service Providers (providers) implement enhanced geo-targeting functionality by November 30, 2019 to allow WEA alert originators ( e.g., local emergency management offices) to target a WEA alert to eligible devices in a prescribed geographic area ( e.g., an area where there is imminent threat of the loss of life or property). See Federal Communications Commission, Wireless Emergency Alerts; Emergency Alert System, 83 FR 8619, 8623 (Feb. 28, 2018) (announcing a Nov. 30, 2019 amendment to 47 CFR 10.450).

The Commission now seeks to evaluate WEA performance, particularly with respect to the accuracy of providers' geo-targeting capabilities. To do so, the Commission will use surveys to collect information and evaluate performance during a WEA test. Survey respondents affiliated with two alert originators, partnered with the Commission in different geographic areas of the country, will be asked to complete a preliminary survey. This survey will improve the utility of a “live test” survey, which respondents will subsequently receive via a hyperlink embedded in a WEA test alert. The Commission has developed survey templates, which are available at https://www.fcc.gov/files/preliminarysurvey0719pdf and https://www.fcc.gov/files/livetestsurvey0719pdf, that are representative of how the surveys will appear on the Commission's Public Safety Support Center, and seeks OMB approval of these templates as a new information collection. The information sought in this collection is necessary and vital to ensuring that WEA is effective at protecting the life and property of the public.

OMB Control Number: 3060-0667.

Title: Section 76.630(a), Compatibility with Consumer Electronic Equipment.

Form Number: N/A.

Type of Review: Revision of a currently approved collection.

Respondents: Business or other for-profit entities.

Number of Respondents and Responses: 1 respondent, 50,001 responses.

Estimated Hours per Response: .017-3 hours.

Frequency of Response: On occasion reporting requirement.

Total Annual Burden: 853 hours.

Total Annual Cost: $1,550.

Privacy Impact Assessment: No impact(s).

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this collection of information is contained in Section 4(i) and Section 632 of the Communications Act of 1934, as amended.

Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information.

Needs and Uses: The information collection requirements contained in 47 CFR 76.630(a) state a cable system operator shall not scramble or otherwise encrypt signals carried on the basic service tier. Requests for waivers of this prohibition must demonstrate either a substantial problem with theft of basic tier service or a strong need to scramble basic signals for other reasons. As part of this showing, cable operators are required to notify subscribers by mail of waiver requests. The notice to subscribers must be mailed no later than thirty calendar days from the date the request waiver was filed with the Commission, and cable operators must inform the Commission in writing, as soon as possible, of that notification date. The notification to subscribers must state: On (date of waiver request was filed with the Commission), (cable operator's name) filed with the Federal Communications Commission a request for waiver of the rule prohibiting scrambling of channels on the basic tier of service. 47 CFR 76.630(a). The request for waiver states (a brief summary of the waiver request). A copy of the request for waiver is on file for public inspection at (the address of the cable operator's local place of business).

Individuals who wish to comment on this request for waiver should mail comments to the Federal Communications Commission by no later than 30 days from (the date the notification was mailed to subscribers). Those comments should be addressed to the: Federal Communications Commission, Media Bureau, Washington, DC 20554, and should include the name of the cable operator to whom the comments are applicable. Individuals should also send a copy of their comments to (the cable operator at its local place of business). Cable operators may file comments in reply no later than 7 days from the date subscriber comments must be filed.

As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the 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; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

OMB Control Number: 3060-XXXX.

Title: Connect America Fund—Performance Testing Measures.

Form Number: N/A.

Type of Review: New information collection.

Respondents: Business or other for-profit.

Number of Respondents and Responses: 1,277 unique respondents; 3,195 responses.

Estimated Time per Response: 16 hours-60 hours.

Frequency of Response: Biennial reporting requirements, quarterly reporting requirements and annual reporting requirements.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 151-154, 155, 201-206, 214, 218-220, 251, 252, 254, 256, 303(r), 332, 403, 405, 410, and 1302.

Total Annual Burden: 120,518 hours.

Total Annual Cost: No Cost.

Privacy Act Impact Assessment: No impact(s).

Nature and Extent of Confidentiality: We note that the Universal Service Administrative Company (USAC) must preserve the confidentiality of certain data obtained from respondents; must not use the data except for purposes of administering the universal service programs or other purposes specified by the Commission; and must not disclose data in company-specific form unless directed to do so by the Commission. Materials or information submitted to the Commission or the Administrator will be confidential and not be available to the public.

Needs and Uses: In the USF/ICC Transformation Order, the Commission laid the groundwork for today's universal service programs providing $4.5 billion in support for broadband internet deployment in high-cost areas. Connect America Fund et al., Report and Order and Further Notice of Proposed Rulemaking, WC Docket No. 10-90 et al., 26 FCC Rcd 17663 (2011) ( USF/ICC Transformation Order ). The USF/ICC Transformation Order required, among other things, that high-cost universal service recipients “test their broadband networks for compliance with speed and latency metrics and certify to and report the results to the Universal Service Administrative Company (USAC) on an annual basis.” Id. at 17705, para. 109. Pursuant to the Commission's direction in that Order, the Wireline Competition Bureau, the Wireless Telecommunications Bureau, and the Office of Engineering and Technology adopted more specific methodologies for such testing in the Performance Measures Order. See Connect America Fund, Order, WC Docket No. 10-90, 33 FCC Rcd 6509 (WCB/WTB/OET 2018) ( Performance Measures Order ). See also 47 CFR 54.313(a)(6) (requiring that recipients of high-cost support provide “[t]he results of network performance tests pursuant to the methodology and in the format determined by the Wireline Competition Bureau, Wireless Telecommunications Bureau, and Office of Engineering and Technology”).

This collection includes requirements for testing speed and latency to ensure that carriers are meeting the public interest obligations associated with their receipt of high-cost universal service support. Carriers will identify, from among the locations they have already submitted and certified in USAC's High Cost Universal Broadband (HUBB) portal, the locations where they have an active subscriber. From those subscriber locations, USAC will then select a random sample from which the carrier will be required to perform testing for speed and latency. Carriers that do not provide location information in the HUBB will use a randomization tool provided by USAC to select a random sample of locations for testing. The carrier will then be required to submit to USAC the results of the testing on an annual basis. These filings will include the testing results for each quarter from the prior year. The carrier's sample for each service tier ( e.g. 10 Mbps/1 Mbps, 25 Mbps/1 Mbps) shall be regenerated every two years. During the two-year cycle, carriers will have the ability to add and remove subscriber locations if necessary, e.g., as subscribership changes. This information collection addresses the burdens associated with these requirements.

OMB Control Number: 3060-1228.

Title: Connect America Fund—High Cost Portal Filing.

Form Number: N/A.

Type of Review: Revision of a currently approved collection.

Respondents: Business or other for-profit, Not-for-profit institutions.

Number of Respondents and Responses: 1,599 unique respondents; 3,730 responses.

Estimated Time per Response: 8 hours-60 hours.

Frequency of Response: On occasion, quarterly reporting requirements, annual reporting requirements, one-time reporting requirement and recordkeeping requirement.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 151-154, 155, 201-206, 214, 218-220, 251, 252, 254, 256, 303(r), 332, 403, 405, 410, and 1302.

Total Annual Burden: 68,607 hours.

Total Annual Cost: No Cost.

Privacy Act Impact Assessment: No impact(s).

Nature and Extent of Confidentiality: We note that USAC must preserve the confidentiality of certain data obtained from respondents; must not use the data except for purposes of administering the universal service programs or other purposes specified by the Commission; and must not disclose data in company-specific form unless directed to do so by the Commission. Respondents may request materials or information submitted to the Commission or the Administrator believed confidential to be withheld from public inspection under 47 CFR 0.459 of the FCC's rules.

Needs and Uses: The Commission is requesting approval for this revised information collection. In March 2016, the Commission adopted an order reforming its universal service support program in areas served by rate-of-return carriers. Connect America Fund et al., WC Docket Nos. 10-90 et al., Report and Order, Order and Order on Reconsideration, and Further Notice of Proposed Rulemaking, FCC 16-33 ( 2016 Rate-of-Return Order ). In May 2016, the Commission adopted rules to implement a competitive bidding process for Phase II of the Connect America Fund. Connect America Fund et al., WC Docket Nos. 10-90 et al., Report and Order and Further Notice of Proposed Rulemaking, FCC 16-64 ( Phase II Auction Order ). In August 2016, the Commission adopted a plan tailored to certain carriers, both fixed and mobile, serving Alaska. Connect America Fund et al., WC Docket No. 10-90 et al., Report and Order and Further Notice of Proposed Rulemaking, FCC 16-115 ( Alaska Plan Order ). In January 2017 the Commission adopted an order which granted New York State waiver of the Connect America Phase II auction program rules, subject to certain conditions. Connect America Fund et al., WC Docket Nos. 10-90 et al., FCC 17-2 ( New York Auction Order ). Also, in December 2018, the Commission adopted reforms that included additional offers of model-based support and increased broadband deployment obligations. Connect America Fund et al., WC Docket No. 10-90 et al., Report and Order, Further Notice of Proposed Rulemaking and Order on Reconsideration, FCC 18-176 ( 2018 Rate-of-Return Order ).

This information collection addresses the requirement that certain carriers with high-cost reporting obligations must file information about their locations which meet their broadband deployment public interest obligations via an electronic portal (“portal”). The 2016 Rate-of-Return Order required that the Universal Service Administrative Company (USAC) establish the portal so that carriers could file their location data with the portal starting in 2017. The 2016 Rate-of-Return Order required all recipients of Phase II model-based support and rate-of-return carriers to submit geocoded location data and related certifications to the portal. Recipients of Phase II model-based support had been required to file such information in their annual reports due by July 1. The Phase II Auction Order, Alaska Plan Order, and New York Auction Order require carriers to build-out networks capable of meeting their public interest obligations and report, to an online portal, locations to which auction winners had deployed such networks. The Alaska Plan Order also made portal reporting requirements for carriers to submit fiber/microwave middle-mile network maps. This information collection also addresses the new additional offers of model-based support and increased broadband deployment obligations, and other improvements to the portal. With the new additional offers, there will be more carriers subject to the model-based deployment milestones and fewer carriers remaining on legacy support.

Pursuant to Section 6(f) of the Federal Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for August 8, 2019), on the World Wide Web, at https://www.ftc.gov/news-events/commission-actions.

You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before September 19, 2019. Write “Unrollme Inc.; File No. 172 3139” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the https://www.regulations.gov website.

Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online through the https://www.regulations.gov website.

If you prefer to file your comment on paper, write “Unrollme Inc.; File No. 172 3139” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 (Annex D), Washington, DC 20580; or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW, 5th Floor, Suite 5610 (Annex D), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.

Because your comment will be placed on the publicly accessible website at https://www.regulations.gov, you are solely responsible for making sure that your comment does not include any sensitive or confidential information. In particular, your comment should not include any sensitive personal information, such as your or anyone else's Social Security number; date of birth; driver's license number or other state identification number, or foreign country equivalent; passport number; financial account number; or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, such as medical records or other individually identifiable health information. In addition, your comment should not include any “trade secret or any commercial or financial information which . . . is privileged or confidential”—as provided by Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)—including in particular competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.

Comments containing material for which confidential treatment is requested must be filed in paper form, must be clearly labeled “Confidential,” and must comply with FTC Rule 4.9(c). In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record. See FTC Rule 4.9(c). Your comment will be kept confidential only if the General Counsel grants your request in accordance with the law and the public interest. Once your comment has been posted on the public FTC website—as legally required by FTC Rule 4.9(b)—we cannot redact or remove your comment from the FTC website, unless you submit a confidentiality request that meets the requirements for such treatment under FTC Rule 4.9(c), and the General Counsel grants that request.

Visit the FTC website at http://www.ftc.gov to read this Notice and the news release describing it. The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding, as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before September 19, 2019. For information on the Commission's privacy policy, including routine uses permitted by the Privacy Act, see https://www.ftc.gov/site-information/privacy-policy.

The Federal Trade Commission (“Commission”) has accepted, subject to final approval, an agreement containing a consent order from Unrollme Inc. (“Unrollme”).

The proposed consent order has been placed on the public record for thirty (30) days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After 30 days, the Commission will again review the agreement and the comments received, and will decide whether it should withdraw from the agreement and take appropriate action or make final the agreement's proposed order.

This matter involves Unrollme's email management service, which Unrollme has offered to consumers since at least June 2012. Unrollme provides services to consumers to help them manage subscription emails, such as newsletters or marketing emails from retailers. During the sign-up process, Unrollme requires consumers to grant Unrollme full access to the email accounts that they wish to enroll in its services. This permission allows Unrollme to access and scan users' inboxes for subscription emails to provide its services. Unrollme also provides access to its users' email accounts to its parent company, Slice Technologies, Inc. (“Slice”). Slice, a market research company, accesses Unrollme users' inboxes in order to collect information from the users' e-receipts, i.e., emailed receipts from businesses following an order or purchase. Slice retains this information, and creates a separate database of anonymous purchase information that it uses in its market research analytics products.

After learning that Unrollme requires access to their email account(s) during the sign-up process, some consumers declined to grant that permission. The proposed complaint alleges that when consumers initially declined to grant permission to their email account(s), Unrollme violated Section 5 of the FTC Act by making false and deceptive statements designed to encourage the consumer to change his or her mind and grant Unrollme access to his or her email account(s) and continue the sign-up process.

Count I of the proposed complaint alleges that Unrollme represented, directly or indirectly, expressly or by implication, that it would not touch users' “personal emails.” From at least January 2015 through November 2015, Unrollme's message to consumers who declined to grant Unrollme access to their email stated, “It looks like you clicked No thanks. In order to use Unroll.me , you need to tell [your email service provider] to allow us to monitor your emails. Don't worry, we won't touch your personal stuff.” (Emphasis added). From November 2015 through October 26, 2016, Unrollme's message to consumers who declined to grant Unrollme access to their email stated, “Authorization Declined In order to use Unroll.me , you need to authorize us to access your emails. Don't worry, this is just to watch for those pesky newsletters, we'll never touch your personal stuff.” (Emphasis added). The proposed complaint alleges that these representations were false or misleading because Unrollme grants Slice access to its users' inboxes, including personal emails in the form of e-receipts, which is then used to collect and sell purchase information contained therein to third parties.

Count II of the proposed complaint alleges that Unrollme represented, directly or indirectly, expressly or by implication, that Unrollme required access to users' inboxes in order to scan for subscription emails. From October 27, 2016, through at least September 2018, Unrollme's message to consumers who declined to grant Unrollme access to their email has stated, “Oops! Looks like you declined access” and “ Unroll.Me requires access to your inbox so we can scan for subscriptions and allow you to begin clearing out your inbox.” The complaint alleges that Unrollme failed to disclose, or failed to disclose adequately, that Unrollme also grants Slice access to its users' inboxes, which Slice then used to collect and sell purchase information contained in users' personal emails in the form of e-receipts and that this fact would be material to consumers in their decision to use Unrollme's services.

The proposed order contains injunctive provisions addressing the alleged deceptive conduct. Part I of the proposed order prohibits misrepresentations about the extent to which Unrollme accesses, collects, uses, stores or shares covered information in connection with any product, service or software operated, owned or distributed by Unrollme that requires access to consumer emails.

Part II of the proposed order requires Unrollme to send an email notification to all known current users who enrolled in Unrollme's services after viewing the challenged statements that explains that Unrollme or its parent access or collect email purchase receipts for use in market research products that are sold to third parties. The required notification is contained in Exhibit A of the proposed order. Part III of the proposed order requires Unrollme to delete within 10 days of the entry of the Order all stored email purchase receipts, and all personally identifiable information obtained from those receipts, for all known users who enrolled in Unrollme's services after viewing the challenged statements.

Parts IV through VII of the proposed order are reporting and compliance provisions, which include recordkeeping requirements and provisions requiring Unrollme to provide information or documents necessary for the Commission to monitor compliance.

Part VIII states that the proposed order will remain in effect for 20 years, with certain exceptions.

The purpose of this analysis is to aid public comment on the proposed order. It is not intended to constitute an official interpretation of the complaint or proposed order, or to modify in any way the proposed order's terms.

I join my colleagues in supporting this settlement, but write separately to highlight the surrounding circumstances, which are relevant to the current privacy debate.

As the complaint alleges, Unroll.me offered a free service that helped consumers organize their email inboxes. It supported this free service by allowing its parent company to scan consumers' emails for purchase-related information, which the parent collected for the anonymized market research it sells. Until around September 2018, the complaint alleges that, in a number of instances, Unroll.me failed adequately to disclose these collection practices, which failure violated the law.

Unrelated to the allegations in the complaint, in late 2018, Google announced it would limit third-party apps (like Unroll.me ) from using the information in Gmail accounts of consumers for purposes such as market research or advertising. 1 Promoted as means to enhance consumer privacy, that decision may also limit consumer choice and competition.

Many millions of consumers see value in Unroll.me's service, which helps them manage the barrage of daily emails crowding their inboxes. Unroll.me has since removed the allegedly deceptive statements and updated its disclosures—consumers may now be better aware of the privacy trade-offs, and continue to use the service. For these consumers, granting access for the collection of purchase data may be a choice worth making. Google's new privacy restrictions threaten to take that option away from consumers. That may be good for privacy, but not for consumer choice.

While Google will retain control of and access to the valuable purchase and other information about consumers contained in their Gmail accounts, other market actors—like Unroll.me and its parent, Rakuten Intelligence, a market research firm—may no longer have access. Google's restrictions thus potentially “imperil the business models of some popular email extensions,”  2 like Unroll.me . That may be good for privacy, but not for competition.

I am not suggesting that Google sought to limit consumer choice or competition, or that it is violating the law. Consumers are focusing increasingly on privacy, and firms like Google may be responding to that demand. But this situation highlights an important aspect of the privacy debate, i.e., the impact that privacy-enhancing decisions may have on consumer choice and competition.

There is no right answer, and we as a society may very well choose limitations on consumer choice and competition to protect privacy. Privacy is important. Consumers and policymakers alike must recognize, however, that it comes with tradeoffs. And competition enforcers must be vigilant, recognizing the potential of privacy efforts negatively to impact competition.

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment:

1. Type of Information Collection Request: Extension without change of a currently approved collection; Title of Information Collection: Social Security Office Report of State Buy-in Problem; Use: The statutory authority for the State Buy-in program is Section 1843 of the Social Security Act, amended through 1989. Under Section 1843, a State can enter into an agreement to provide Medicare protection to individuals who are members of a Buy-in coverage group, as specified in the State's Buy-in agreement. The Code of Federal Regulations at 42 CFR Section 407.40 provides for States to enroll in Medicare and pay the premiums for all eligible members covered under a Buy-in coverage group. Individuals enrolled in Medicare through the Buy-in program must be eligible for Medicare and be an eligible member of a Buy-in coverage group. The day to day operations of the State Buy-in program is accomplished through an automated data exchange process. The automated data exchange process is used to exchange Medicare and Buy-in entitlement information between the Social Security District Offices, State Medicaid Agencies and the Centers for Medicare & Medicaid Services (CMS). When problems arise that cannot be resolved though the normal data exchange process, clerical actions are required. The CMS-1957, “SSO Report of State Buy-In Problem” is used to report Buy-in problems cases. The CMS-1957 is the only standardized form available for communications between the aforementioned agencies for the resolution of beneficiary complaints and inquiries regarding State Buy-in eligibility. Form Number: CMS-1957 (OMB control number: 0938-0035); Frequency: Yearly; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 5,854; Total Annual Responses: 5,854; Total Annual Hours: 1,951. (For policy questions regarding this collection contact Keith Johnson at 410-786-1148.)

2. Type of Information Collection Request: Reinstatement without change of a currently approved collection; Title of Information Collection: Summary of Benefits and Coverage and Uniform Glossary; Use: This information collection will ensure that consumers shopping for or enrolled in private, individually purchased, or non-federal governmental group health plan coverage receive the consumer protections of the Affordable Care Act. Employers, employees, and individuals will use this information to compare coverage options prior to selecting coverage and to understand the terms of, and extent of medical benefits offered by, their coverage (or exceptions to such coverage or benefits) once they have coverage. Form Number: CMS-10407 (OMB control number: 0938-1146); Frequency: Yearly; Affected Public: Private Sector—Business or other for-profits and not-for-profit institutions; Number of Respondents: 128,511; Total Annual Responses: 24,433,233; Total Annual Hours: 41,551. (For policy questions regarding this collection contact Jessica Weinberg at 301-492-4404.)

Contents

This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES ).

Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice.

1. Type of Information Collection Request: Extension without change of a currently approved collection; Title of Information Collection: Advance Beneficiary Notice of Noncoverage (ABN); Use: The use of the written Advance Beneficiary Notice of Non-coverage (ABN) is to inform Medicare beneficiaries of their liability under specific conditions. This has been available since the “limitation on liability” provisions in section 1879 of the Social Security Act (the Act) were enacted in 1972 (Pub. L. 92-603). ABNs are not given every time items and services are delivered. Rather, ABNs are given only when a physician, provider, practitioner, or supplier anticipates that Medicare will not provide payment in specific cases.

An ABN may be given, and the beneficiary may subsequently choose not to receive the item or service. An ABN may also be issued because of other applicable statutory requirements other than § 1862(a)(1) such as when a beneficiary wants to obtain an item from a supplier who has not met Medicare supplier number requirements, as listed in section 1834(j)(1) of the Act or when statutory requirements for issuance specific to HHAs are applicable.

ABNs are usually given as hard copy notices during in-person patient encounters. In some cases, notification may be done by telephone with a follow-up notice mailed. Electronic issuance of ABNs is permitted as long as the beneficiary is offered the option to receive a paper copy of the notice if this is preferred. Regardless of the mode of delivery, the beneficiary must receive a copy of the signed ABN for his/her own records. Incorporation of ABNs into other automated business processes is permitted, and some limited flexibility in formatting the notice in such cases is allowed, as discussed in the form instructions. Notifiers may choose to store the required signed copy of the ABN electronically. Form Number: CMS-R-131 (OMB control number: 0938-0566); Frequency: Yearly; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 1,589,060; Total Annual Responses: 382,216,385; Total Annual Hours: 44,593,186. (For policy questions regarding this collection contact Jennifer McCormick at 410-786-2852.)

Description: This information collection was approved alongside the final rule for the revised HSPPS on September 1, 2016. This information collection is entirely record keeping and does not contain any standardized instruments or instructions. For example, this includes the requirement that programs maintain a waiting list of eligible families. There are no changes to the record keeping requirements contained in this information collection. Only minor adjustments were made to the estimated burden based on updated enrollment and staff data.

Respondents: Head Start grantees.

Description: The Head Start Act at Sec. 650(b) requires the submission of a report to the Committee on Education and Labor of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate concerning the condition, location, and ownership of facilities used by AIAN grantees. This report is required once during every 5-year period. The proposed collection is a brief survey on the condition and ownership of AIAN facilities for the purpose of this report.

Respondents: AIAN Head Start grantees

Estimated Total Annual Burden Hours: 54.25.

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 Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, ACL is publishing a notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, ACL invites comments on our burden estimates or any other aspect of this collection of information, including:

(1) Whether the proposed collection of information is necessary for the proper performance of ACL's functions, including whether the information will have practical utility;

(2) the accuracy of ACL's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used to determine burden estimates;

(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.

Description: The Administration for Community Living (ACL) in the U.S. Department of Health and Human Services (HHS) is seeking OMB approval to collect data using new information collection tools that examine if and how APS programs make a difference in the lives of APS clients. APS programs are provided by state and local governments nationwide and serve older adults and adults with disabilities in need of assistance due to maltreatment, which can include: Physical, emotional, and sexual abuse; financial exploitation; neglect; and self-neglect. APS is an important avenue through which maltreatment is reported to law enforcement or other agencies.

Additionally, APS programs are often the gateway for adults who experience maltreatment to access additional community, social, health, behavioral health, and legal services to maintain independence in the settings in which they prefer to live. APS programs work closely with clients and a wide variety of allied professionals to maximize safety and independence, while respecting each client's right to self-determination. At this time, there is no single funding stream for APS nor a single set of rules and regulations that APS programs must follow. Building the evidence-base for APS programs and practices, promoting the use of evidence-based and promising practices, and developing guiding standards are key needs for the APS field. The proposed new data collection is an important component for building the evidence-base for APS programs and practices in improving client outcomes.

Specifically, the data collection will help examine (1) what changes clients report as a result of receiving APS services; (2) how satisfied clients are with the APS services they receive; (3) to what extent clients report APS helps them achieve their goals; (4) to what extent clients report APS supports their right to self-determination; (5) to what extent APS programs affect client safety (risk of maltreatment); (6) how APS program intervene to reduce client risk of maltreatment; (7) what factors help or hinder APS efforts to reduce risk of maltreatment; (8) to what extent APS programs affect client well-being ( e.g., quality of life, financial, physical health, etc.); (9) how APS programs intervene to improve client-well-being; and (10) what factors help or hinder APS efforts to improve client well-being. The data collection will be conducted with three target populations: (1) APS clients, (2) APS caseworkers, and (3) APS leaders. APS leaders will consist of APS state and APS county leaders.

Data collection with these three target populations will include: A brief, anonymous APS client questionnaire, including a de-identified client data form; a semi-structured in-person interview with APS clients; a semi-structured in-person focus group with APS caseworkers; and a semi-structured interview with APS leaders.

The APS client questionnaire is designed to be as brief as possible, while examining key client outcome areas, identified in collaboration with a national expert panel consisting of federal experts, researchers, practitioners, and program leaders in APS. The outcomes areas focus on: Satisfaction with APS, safety, and well-being, and will be assessed with nine questions. The question statements examining these areas are designed to be short and easy to understand. The first item on the questionnaire provides a simple “yes/no” response option. For the remaining questions, APS clients or a proxy (respondents) are asked to rate the extent which they agree with each statement using a Likert-type rating scale ranging from `strongly disagree' to `strongly agree'. Respondents also have the option of sharing anything else about their experience with APS through an open-ended question at the end of the form. The questionnaire will be hand-delivered to the client or proxy respondent by the APS caseworker at case closure. The respondent will complete the questionnaire and mail it back to the research team by using a prepaid return envelope.

The client data form will be linked to the client questionnaire using a pre-populated eight-digit form number. The client data form is designed to capture de-identified, basic demographic information and additional details about APS clients and their cases.

These data points are expected to be among the information about clients, and their cases, that caseworkers already collect during normal APS processes. The form does not collect any personally identifiable information. The form will be completed online by APS caseworkers. If an APS program prefers another method of completing the form, hard copies can be provided and mailed back to the research team using a prepaid return envelope.

Individual interviews with APS clients are designed to gain more in-depth knowledge about the experiences and needs of APS clients along the key outcome areas assessed in the questionnaire. A standardized, semi-structured interview guide will be used to guide the interviews with clients who provide informed consent. Focus groups with APS caseworkers will be conducted in person, using a standardized, semi-structured focus group guide. Individual interviews with APS leaders will be conducted either in-person or by phone with county and state leaders using a standardized, semi-structured, interview guide. Similar to client interviews, focus groups with APS caseworkers and interviews with APS leaders will focus on the identified outcome areas. Additional questions will be asked to gain insight into access and availability of services, collaboration and partnerships with other entities in the community, and barriers and facilitating factors that affect APS services and client outcomes. The interview guide for APS leaders also contains questions related to APS polices and procedures.

The proposed data collection tools may be found on the ACL website for review at https://www.acl.gov/about-acl/public-input.

Estimated Program Burden: ACL estimates the burden associated with this collection of information as follows:

In the Federal Register of Wednesday, June 8, 2011 (76 FR 33310), appearing on page 33310 in FR Doc. 2011-14164, the following correction is made:

On page 33311, in table 1, in the “Applicant” column for NDA 018380, correct the entry “Do.” to read “Hospira, Inc., 275 North Field Dr., Bldg. H2, Lake Forest, IL 60045-5046.”

I. Background

Data standards help FDA receive, process, review, and archive submission data more efficiently and effectively. Study data standards describe a standard way to exchange clinical and nonclinical research data between computer systems. These standards provide a consistent general framework for organizing study data, including templates for datasets, standard names for variables, and standard ways of doing calculations with common variables. Study data standards are required for study data submitted to FDA's Center for Drug Evaluation and Research (CDER) per the published guidance. 1

CDISC is an open, multidisciplinary, nonprofit organization that has established worldwide industry standards to support the electronic acquisition and submission of study data and metadata for medical and biopharmaceutical product development. 2 CDISC is currently facilitating and testing the extension of the SEND 3.1 standard for nonclinical toxicology data.

CDER completed a pilot project evaluating SEND 3.0 using SEND-formatted sample toxicology datasets. Phase 1 of the pilot supported the development of a SEND Implementation Guide (SENDIG) describing the process for formatting data from single and repeat-dose animal toxicity and carcinogenicity studies for submission purposes. During Phase 2 of the pilot, CDER evaluated submission of SEND formatted datasets and evaluated data validation and analysis tools capabilities. The outcomes of this pilot resulted in improvements to the SENDIG 3.0. 3

Based on published guidance  4 studies initiated after December 17, 2016, must be submitted with data formatted in accordance with the data standards listed in the FDA Data Standards Catalog for new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new drug applications (ANDAs). For investigational new drug applications (INDs), the requirement  5 applies to studies initiated after December 17, 2017. SEND 3.1 is included in the Data Standards Catalog, and the submission of SEND nonclinical datasets is expected to continue to increase in the future. This pilot will evaluate the compliance of sample SEND 3.1 datasets submitted to CDER. As part of this evaluation and in anticipation of FDA receiving datasets for regulatory review, the CDISC SEND team, in collaboration with CDER and available pilot participants, will update the SENDIG 3.1 as needed to include specific data elements and terms.

CDER is seeking a maximum of five participants in this pilot. The Center will use its discretion in choosing participants based on the completeness of the submission per the guidelines below. CDER requests participants to submit a nonclinical study package containing the following materials:

• SEND 3.1 datasets  6

• Sample related study report  7 (PDF format)

• Nonclinical Study Data Reviewers Guide  8

• Define.xml (v2.0)  9

• Sample standardized study protocol.

CDER will prioritize nonclinical packages that highlight the most significant changes from SENDIG 3.0 to SENDIG 3.1 and therefore, the studies that meet as many of the following criteria as possible:

1. Toxicology studies with safety pharmacology data that demonstrate appropriate use of:

a. Continuous data typically included in these safety pharmacology studies:

(i) Cardiovascular data represented in the Electrocardiogram (ECG) Test Results Domain, Electrocardiogram Domain (EG), and the Cardiovascular Test Results Domain (CV).

(ii) Respiratory data in the Respiratory Test Results Domain (RE).

b. Timing variables for Planned Start of Assessment Interval (—STINT), and Planned End of Assessment Interval (—ENINT) (in the use of timing variables in the EG domain).

c. Unscheduled Flag, (—USCHFL) variable.

d. Nominal Study Day for Tabulations, (—NOMDY), Label for Nominal Study Day, (—NOMLBL) variable to group and label data for reporting purposes.

e. Study data from a study or studies using the Latin Square design.

2. Toxicology studies including Pharmacokinetic Concentrations Domain (PC) and Pharmacokinetics Parameters Domain (PP) domains.

3. Toxicology studies with study data using controlled terminology (version 2018-03-30 or later) for:

a. Severity.

b. Non-neoplasm (NONNEO) using codelist NONNEO and Microscopic Domain (MI).

Please indicate in your request for participation the extent to which your submission will meet the above listed criteria.

This pilot is intended to inform on the readiness of the SEND 3.1 standard and support improvements to the SENDIG 3.1 that will benefit FDA and submitters. Pilot participants commit to publicly share lessons learned with the CDISC SEND team to ensure that the CDISC SEND standard is improved for the community. Participants may redact any sensitive information as needed to enable sharing FDA feedback with the CDISC SEND team.

Requests to participate in the SENDIG 3.1 FFU pilot are to be identified with the docket number found in brackets in the heading of this document. Interested persons should include the following information in the request: Contact name, contact phone number, email address, name of the sponsor, address, and license number, as well as the description of criteria met, addressing each of the items in the II. Project Participation section.

Once requests for participation are received, CDER will contact interested sponsors to discuss the pilot project and clarify requirements and expectations. The elapsed time duration of the pilot is expected to be approximately 6 months but may be extended as needed.

FDA is requesting nominations for voting members to fill upcoming vacancies on the Blood Products Advisory Committee.

The Committee reviews and evaluates available data concerning the safety, effectiveness, and appropriate use of blood, products derived from blood and serum or biotechnology which are intended for use in the diagnosis, prevention, or treatment of human diseases, and, as required, any other product for which FDA has regulatory responsibility, and advises the Commissioner of Food and Drugs (the Commissioner) of its findings regarding screening and testing (to determine eligibility) of donors and labeling of the products, on clinical and laboratory studies involving such products, on the affirmation or revocation of biological products licenses, and on the quality and relevance of FDA's research program which provides the scientific support for regulating these agents. The Committee will function at times as a medical device panel under the Federal Food, Drug, and Cosmetic Act Medical Device Amendments of 1976. As such, the Committee recommends classification of devices subject to its review into regulatory categories; recommends the assignment of a priority for the application of regulatory requirements for devices classified in the standards or premarket approval category; advises on formulation of product development protocols and reviews premarket approval applications for those devices to recommend changes in classification as appropriate; recommends exemption of certain devices from the application of portions of the Act; advises on the necessity to ban a device; and responds to requests from the Agency to review and make recommendations on specific issues or problems concerning the safety and effectiveness of devices.

The Committee consists of a core of 17 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of clinical and administrative medicine, hematology, immunology, blood banking, surgery, internal medicine, biochemistry, engineering, biological and physical sciences, biotechnology, computer technology, statistics, epidemiology, sociology/ethics, and other related professions. Almost all non-Federal members of this committee serve as Special Government Employees. Members will be invited to serve for terms of up to 4 years.

Any interested person may nominate one or more qualified persons for membership on the advisory committee. Self-nominations are also accepted. Nominations must include a current, complete résumé or curriculum vitae for each nominee, including current business address, telephone number, and email address if available and a signed copy of the Acknowledgement and Consent form available at the FDA Advisory Nomination Portal (see ADDRESSES ). Nominations must specify the advisory committee for which the nominee is recommended. Nominations must also acknowledge that the nominee is aware of the nomination unless self-nominated. FDA will ask potential candidates to provide detailed information concerning such matters related to financial holdings, employment, and research grants and/or contracts to permit evaluation of possible sources of conflicts of interest.

This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

Agenda: The committee will discuss new drug application (NDA) 209445, cefiderocol lyophilized powder for intravenous administration, submitted by Shionogi Inc., for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis due to gram-negative bacteria in patients with limited or no alternative treatment options.

FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's website after the meeting. Background material is available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link.

Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. All electronic and written submissions submitted to the Docket (see the ADDRESSES section) on or before October 1, 2019, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2:30 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before September 23, 2019. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by September 24, 2019.

Persons attending FDA's advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets.

For press inquiries, please contact the Office of Media Affairs at fdaoma@fda.hhs.gov or 301-796-4540.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Lauren Tesh Hotaki (see FOR FURTHER INFORMATION CONTACT ) at least 7 days in advance of the meeting.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).

The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).

A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug.

Dextrose, 20 g/100 mL, and Dextrose, 50 g/100 mL, in plastic containers, are the subject of NDA 017521, held by Baxter Healthcare Corporation and initially approved on August 28, 1979. Dextrose, 20 g/100 mL, and Dextrose, 50 g/100 mL, in plastic containers, are indicated as a source of calories when mixed with amino acids or other compatible intravenous fluids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.

Dextrose, 20 g/100 mL, and Dextrose, 50 g/100 mL, in plastic containers (NDA 017521), are currently listed in the “Discontinued Drug Product List” section of the Orange Book.

Fresenius Kabi USA, LLC, submitted a citizen petition dated January 29, 2019 (Docket No. FDA-2019-P-0466), under 21 CFR 10.30, requesting that the Agency determine whether Dextrose, 20 g/100 mL, and Dextrose, 50 g/100 mL, in plastic containers (NDA 017521), were 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 Dextrose, 20 g/100 mL, and Dextrose, 50 g/100 mL, in plastic containers (NDA 017521), were not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that Dextrose, 20 g/100 mL, and Dextrose, 50 g/100 mL, in plastic containers, were withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of Dextrose, 20 g/100 mL, and Dextrose, 50 g/100 mL, in plastic containers, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that these drug products were withdrawn from sale for reasons of safety or effectiveness.

Accordingly, the Agency will continue to list Dextrose, 20 g/100 mL, and Dextrose, 50 g/100 mL, in plastic containers (NDA 017521), 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 Dextrose, 20 g/100 mL, and Dextrose, 50 g/100 mL, in plastic containers (NDA 017521), 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.

I. Background

In December 2017, FDA launched its Predictive Toxicology Roadmap, a six-part framework for integrating predictive toxicology methods into safety and risk assessments. Among other recommendations, the Roadmap calls for FDA research to identify data gaps and to support intramural and extramural research to ensure that the most promising technologies are developed, validated, and integrated into regulatory review, if applicable.

FDA held its initial public hearing on the Roadmap, sponsored by FDA's cross-agency Toxicology Working Group, on September 12, 2018. More information about the Roadmap as well as the initial public hearing can be found on the following website: https://www.fda.gov/predictivetoxroadmap.

On Wednesday, September 18, 2019, FDA will highlight the work it has been doing to support and implement FDA's Predictive Toxicology Roadmap.

Registration: To register for the public workshop, please visit the following website: https://www.fda.gov/predictivetoxroadmap.

Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public workshop must register by Monday, September 16, 2019, 5 p.m. Eastern Time. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted.

If you need special accommodations due to a disability, please contact Laurie-Anne Sayles (see FOR FURTHER INFORMATION CONTACT ) no later than September 11, 2019, 5 p.m. Eastern Time.

Streaming Webcast of the Public Workshop: This public workshop will also be webcast. To register for the webcast, please visit the following website: https://www.fda.gov/predictivetoxroadmap.

If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit https://www.adobe.com/go/connectpro_overview. FDA has verified the website addresses in this document, as of the date this document publishes in the Federal Register , but websites are subject to change over time.

Transcripts: Please be advised that as soon as a transcript of the public workshop is available, it will be accessible at https://www.fda.gov/predictivetoxroadmap.

Agenda: The committee will discuss new drug application (NDA) 204017 (levonorgestrel and ethinyl estradiol) transdermal system, submitted by Agile Therapeutics, Inc., for the prevention of pregnancy in women of reproductive potential.

FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's website after the meeting. Background material is available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link.

Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. All electronic and written submissions submitted to the Docket (see the ADDRESSES section) on or before October 16, 2019, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before October 7, 2019. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by October 8, 2019.

Persons attending FDA's advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets.

For press inquiries, please contact the Office of Media Affairs at fdaoma@fda.hhs.gov or 301-796-4540.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Kalyani Bhatt (see FOR FURTHER INFORMATION CONTACT ) at least 7 days in advance of the meeting.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (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.

Title of the Collection: Evaluation of the Kidney Innovation Accelerator (KidneyX).

Type of Collection: New.

Abstract: The Office of the Chief Technology Officer (CTO) is initiating an independent evaluation under the Department of Health & Human Services (HHS) of the Kidney Innovation Accelerator—or KidneyX—a public-private partnership between HHS/CTO and the American Society of Nephrology (ASN).

The KidneyX evaluation involves a mixed-methods design for data collection and analysis. The evaluation integrates qualitative techniques, such as document analysis and stakeholder interviews, to capture the details and effects of processes and changes within the KidneyX initiative. We will apply quantitative methods, such as surveys and econometric analysis, in discrete situations in which we find sufficient certainty and coherence in environmental conditions to conduct rigorous analysis.

The evaluation will use a data-driven set of methodologies to address, to the extent possible, the central question of the effectiveness of KidneyX: The degree to which KidneyX contributed to any acceleration in the rate of innovation in the targeted area of kidney technology compared with how innovation would have progressed without KidneyX.

Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (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.

Title of the Collection: Youth Engagement in Sports (YES) Performance Measures.

Type of Collection: New.

Abstract: The Office of Minority Health (OMH) and Office of Women's Health (OWH) are seeking an approval by OMB on a new information collection, Youth Engagement in Sports (YES Initiative) Performance Measures (hereafter YES Initiative Performance Measures). The purpose of this data collection is to gather quantitative data from YES grant recipients to monitor project performance in achieving process and outcome measures over the course of the three-year project. Grantees will collect a small set of process and outcome measures from program participants to assess the degree to which YES Initiative projects increase sports participation and physical activity and improve nutrition in adolescents.

Need and Proposed Use of the Information: The clearance is needed to collect performance data to enable OMH and OWH to comply with Federal reporting requirements, monitor, and evaluate performance by enabling the efficient collection of performance-oriented data tied to OMH- and OWH-wide performance reporting needs. The ability to monitor and evaluate performance in this manner, and to work towards continuous program improvement are basic functions that OMH and OWH must be able to accomplish in order to carry out their respective mandates with the most effective and appropriate use of resources.

Likely Respondents: Project Directors, Youth Participants, Data Entry Persons Affected public includes non-profit institutions, State, Local, or Tribal Governments.

Technology description follows:

IRF8, a member of interferon regulatory factor (IRF) family of transcription factors is a novel intrinsic transcriptional inhibitor of TH17-cell differentiation. TH17-cells are believed to be involved in the pathogenesis of various autoimmune/inflammatory diseases. The Irf8f floxed targeted mutated mouse strain can be used to selectively ablate expression of IRF8 in any cell type in which a Cre recombinase gene is activated. This will permit the identification of IRF8-regulated genes and their effects in specific types of developing and mature cells. These materials could be used to help define patterns of gene expression important for the development and function of cells including possible contributions to understanding: Normal immune responses, inflammatory conditions, autoimmunity and anti-viral responses.

This technology is available for licensing for commercial development in accordance with 35 U.S.C. 209 and 37 CFR part 404.

• Target identification in B and T cell deficiency, macrophage defects and hematopoiesis.

• A tool for investigating IRF8 mediated issues associated with inflammation and autoimmunity.

• Investigative tool for development of potential therapeutics for lymphoma and Human Chronic Myeloid Leukemia.

• Mice with established germ line transmission for use in conditional deletion of the IRF8 gene in any cell type.

• Research Use.

Inventors: Herbert Carpenter Morse III (NIAID).

Publications: Ouyang, Xinshou, et al. “Transcription factor IRF8 directs a silencing programme for TH17 cell differentiation.” Nature Communications 2, Article number: 314 (2011).

Licensing Contact: To license this technology, please contact Chris Kornak at 240-627-3705 or Chris.Kornak@nih.gov, and reference E-062-2012-0.

Intellectual Property E-016-2015: Chimeric Antigen Receptor Targeting both CD19 and CD22

1. U.S. Provisional Patent Application 62/135,442, filed March 19, 2015 (E-106-2015-0-US-01);

2. International Patent Application PCT/US2016/023055, filed March 18, 2016 (E-106-2015/0-PCT-02)

3. U.S. Patent Application No.: 15/559,485, filed September 19, 2017 (E- E-106-2015/0-US-03)

1. U.S. Provisional Patent Application 62/506,268, filed May 15, 2017 (E-017-2017-0-US-01);

2. International Patent Application PCT/US2018/032,809, filed May 15, 2018 (E-017-2017/0-PCT-02)

The patent rights in these inventions have been assigned and/or exclusively licensed to the government of the United States of America.

The prospective exclusive license territory may be worldwide, and the fields of use may be limited to the following:

This technology discloses CAR therapies that target both CD19 and CD22 by utilizing the anti-CD19 binder known as FM63 and the anti-CD22 binder known as M971. CD19 and CD22 are each expressed on the surface of B cells in B cell malignancies and are hallmark examples of antigen targeting in CAR-T therapies, with CD19-targeting CAR-T therapies being the first FDA approved CAR-T, and CD22-targeting CAR-T showing early promise in clinical trials for ALL and NHL.

This Notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license will be royalty bearing, and the prospective exclusive license may be granted unless within thirty (30) days from the date of this published Notice, the National Cancer Institute 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.

In response to this Notice, the public may file comments or objections. Comments and objections, other than those in the form of a license application, will not be treated confidentially, and may be made publicly available.

License applications submitted in response to this Notice will be presumed to contain business confidential information and any release of information from these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552.

Technology description follows.

Nipah virus is an emerging pathogenic paramyxovirus responsible for sporadic and isolated outbreaks of severe respiratory and neurologic disease in Southern Asia. As a zoonotic virus, disease can manifest in both animals and human with indigenous fruit bats acting as natural reservoirs of the virus. The effects of viral infection vary from acute respiratory distress to fatal encephalitis. There are currently no approved therapeutics or vaccines against the virus, and growing concerns that this highly pathogenic infection has the potential to cause larger epidemics capable of inflicting significant mortality burden.

Like the RSV fusion (F) glycoprotein, the Nipah fusion glycoprotein is a target of neutralizing antibodies that mediate protection against infection. Previous studies of prefusion-stabilized F glycoproteins from pneumoviruses and other paramyxoviruses ( e.g. RSV and PIVs) have shown they elicit higher titers of neutralizing antibodies in both animals and humans than post-fusion F proteins.

Researchers at the Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID) designed disulfide, cavity-filling and other mutations that stabilize the Nipah F glycoprotein in the prefusion conformation and bind prefusion-specific antibodies. These mutations also increase protein expression yields up to 50-fold making the recombinant proteins easy to manufacture and amenable to the use of genetic immunization using nucleic acid or vector-based applications.

The stabilized prefusion state of the Nipah F glycoprotein may be an ideal vaccine immunogen to elicit broad potent Nipah neutralizing antibodies. First and second generation prefusion molecules have been designed and tested in small animals and results (immunogenicity and stability) appear promising.

This technology is available for licensing for commercial development in accordance with 35 U.S.C. 209 and 37 CFR part 404.

• Vaccine—to elicit potent neutralizing antibodies against the Nipah Env glycoprotein.

Nipah prefusion F design has the following features compared to wild-type fusion glycoprotein:

• Robust stabilization.

• Up to 50-fold increase in expression yields, making the recombinant proteins easy to manufacture.

• Potential to link the recombinant glycoprotein to nanoparticles or oligomerization peptides.

Development Stage: In vivo testing (rodents).

Inventors: Barney S. Graham (NIAID), Rebecca J. Loomis (NIAID), Guillaume Stewart-Jones (NIAID), John R. Mascola (NIAID), and Jason McLellan (NIAID).

Intellectual Property: HHS Reference Number E-050-2018 includes U.S. Provisional Patent Application Number 62/714,230 filed 08/03/2018.

Related Intellectual Property: PCT Application No. PCT/US2008/087719 filed 19/12/2008.

Licensing Contact: Vince Contreras, Ph.D., 240-669-2823; vince.contreras@nih.gov.

Notice of this meeting is in compliance with the Federal Advisory Committee Act, 5 U.S.C. App.

The Merchant Mariner Medical Advisory Committee Meeting is authorized by U.S. Code, Title 46, section 7115. The Committee advises the Secretary of the Department of Homeland Security on matters related to (a) medical certification determinations for issuance of licenses, certificates of registry, and merchant mariners' documents; (b) medical standards and guidelines for the physical qualifications of operators of commercial vessels; (c) medical examiner education; and (d) medical research.

The agenda for the September 10, 2019, meeting is as follows:

(1) The full Committee will meet briefly to discuss the Working Groups' business/task statements, which are listed under paragraph 2 (a)-(c) below.

(2) Working Groups will separately address the following task statements, which are available at https://homeport.uscg.mil/missions/ports-and-waterways/safety-advisory-committees/medmac.

(a) Task statement 16-24 Recommendations on Appropriate Diets and Wellness for Mariners While Onboard Merchant Vessels;

(b) Task Statement 18-27, Recommendations on Mariner Mental Health; and

(c) Task Statement 18-28, Communication Between External Stakeholders and the Mariner Credentialing Program.

(3) Public comment period.

(4) Reports of working groups. At the end of the day, the working groups will report to the full Committee on what was accomplished in their meetings. The full Committee will not take action on these reports on this date. Any official action taken as a result of these Working Group meetings will be taken on day two of the meeting.

(5) Adjournment of meeting.

The agenda for the September 11, 2019, meeting is as follows:

(1) Introduction.

(2) Designated Federal Officer announcements.

(3) Remarks from U.S. Coast Guard Leadership.

(4) Roll call of Committee members and determination of a quorum.

(5) Reports from the following Working Groups:

(a) Task statement 16-24 Recommendations on Appropriate Diets and Wellness for Mariners While Onboard Merchant Vessels;

(b) Task Statement 18-27, Recommendations on Mariner Mental Health; and

(c) Task Statement 18-28, Communication Between External Stakeholders and the Mariner Credentialing Program.

(6) New Business:

(a) Task Statement X-1, Review of Coast Guard forms CG-719K, CG-719K/E and CG-719P;

(b) Task Statement X-2, Additional Guidance on Conduct of the General Medical Exam; and

(c) Task Statement X-3, Medical Certifications for Military to Mariner Applicants.

(7) Other items for discussion:

(a) USCG FACA changes due to the Frank LoBiondo Coast Guard Authorization Act of 2018;

(b) Mariner Credentialing Program; and

(c) NMC 6 Medical Evaluation Presentation.

(8) Public comment period.

(9) Discussion of Working Group recommendations. The Committee will review the information presented on each issue, deliberate on any recommendations presented by the Working Groups, approve/formulate recommendations and close any completed tasks. Official action on these recommendations may be taken on this date.

(10) Closing remarks/plans for next meeting.

(11) Adjournment of meeting.

A copy of all meeting documentation will be available at https://homeport.uscg.mil/missions/ports-and-waterways/safety-advisory-committees/medmac no later than September 4, 2019. Alternatively, you may contact Mr. Davis Breyer as noted in the FOR FURTHER INFORMATION CONTACT section above.

A public comment period will be held during each working group and full Committee meeting concerning matters being discussed. Public comments will be limited to three minutes per speaker. Please note that the meeting may adjourn early if the work is completed. Contact the individual listed in the FOR FURTHER INFORMATION CONTACT section above, to register as a speaker.

The United States is signatory to the International Maritime Organization's International Regulations for Preventing Collisions at Sea, 1972 (72 COLREGS), as amended. The special construction or purpose of some vessels makes them unable to comply with the light, shape, or sound signal provisions of the 72 COLREGS. Under statutory law, however, specified 72 COLREGS provisions are not applicable to a vessel of special construction or purpose if the Coast Guard determines that the vessel cannot comply fully with those requirements without interfering with the special function of the vessel. 1

The owner, builder, operator, or agent of a special construction or purpose vessel may apply to the Coast Guard District Office in which the vessel is being built or operated for a determination that compliance with alternative requirements is justified, 2 and the Chief of the Prevention Division would then issue the applicant a certificate of alternative compliance (COAC) if he or she determines that the vessel cannot comply fully with 72 COLREGS light, shape, and sound signal provisions without interference with the vessel's special function. 3 If the Coast Guard issues a COAC, it must publish notice of this action in the Federal Register . 4

The Chief of Prevention Division, Seventh District, U.S. Coast Guard, certifies that the CAPT. JIM MCALLISTER (O.N. 1289659) is a vessel of special construction or purpose, and that, with respect to the positions of the stern and sidelights, it is not possible to comply fully with the requirements of the provisions enumerated in the 72 COLREGS, without interfering with the normal operation, construction, or design of the vessel. The Chief of Prevention Division, Seventh District, U.S. Coast Guard, further finds and certifies that the lights are configured in the closest possible compliance with the applicable provisions of the 72 COLREGS. 5

Notice of this meeting is in compliance to the Federal Advisory Committee Act, 5 U.S.C. App.

The Merchant Marine Personnel Advisory Committee is established under authority of U.S. Code, title 46, section 8108. The Committee acts solely in an advisory capacity to the Secretary of the Department of Homeland Security through the Commandant of the U.S. Coast Guard on matters relating to personnel in the United States merchant marine, including training, qualifications, certification, documentation, and fitness standards and other matters as assigned by the Commandant. The Committee also reviews and comments on proposed U.S. Coast Guard regulations and policies relating to personnel in the United States merchant marine, including training, qualifications, certification, documentation, and fitness standards.

The agenda for the September 16, 2019 meeting is as follows:

(1) The full Committee will meet briefly for organizational purposes.

(2) The members of the Committee and the attending public will meet in an informal discussion group in order to provide insights on the advantages and disadvantages of autonomous ships from an operational and training perspective.

(3) The members of the Committee and the attending public will meet in an informal discussion group in order to provide insights on the review of the International Convention on Standards of Training, Certification and Watchkeeping for Seafarers (STCW), 1978, as amended.

(4) Adjournment of meeting.

The agenda for the September 17, 2019, meeting is as follows:

(1) The full Committee will meet briefly to discuss the working groups' business/task statements, which are listed under paragraph (2) (a)-(d) below.

(2) Working groups will separately address the following task statements which are available for viewing at https://homeport.uscg.mil/missions/ports-and-waterways/safety-advisory-committees/merpac;

(a) Task Statement 89, Review of MSC Circular MSC/Circ.1014, Guidelines on fatigue mitigation and management;

(b) Task Statement 90, Review of IMO Model Courses Being Validated by the IMO HTW Subcommittee;

(c) Task Statement 94, MERPAC Recommendation Review; and

(d) Task Statement 101, Communication Between External Stakeholders and the Mariner Credentialing Program.

(3) Working groups will separately address the following proposed task statements which are available for viewing at https://homeport.uscg.mil/missions/ports-and-waterways/safety-advisory-committees/merpac.

(a) Revised Task Statement 101, Provide feedback and avenues to further enhance open communication between external stakeholders and the U.S. Coast Guard's mariner credentialing program regarding all aspects of the program;

(b) Task Statement X-1, Military Education, Training and Assessment for STCW and National Mariner Endorsements;

(c) Task Statement 90 Addendum a, National Model Courses;

(d) Task Statement 101 Addendum b, Review of Coast Guard Forms.

(4) Public comment period.

(5) Reports of working groups. At the end of the day, the working groups will report to the full Committee on what was accomplished in their meetings. The full Committee will not take action on these reports on this date. Any official action taken as a result of these working group meetings will be taken on day three of the meeting.

(6) Adjournment of meeting.

The agenda for the September 18, 2018 full Committee meeting is as follows:

(1) Introduction.

(2) Remarks from U.S. Coast Guard Leadership.

(3) Designated Federal Officer announcements.

(4) Roll call of Committee members and determination of a quorum.

(5) Reports from the following Working Groups:

(a) Task Statement 89, Review of MSC Circular MSC/Circ.1014, Guidelines on fatigue mitigation and management;

(b) Task Statement 90, Review of IMO Model Courses Being Validated by the IMO HTW Subcommittee;

(c) Task Statement 94, MERPAC Recommendation Review; and

(d) Task Statement 101, Communication Between External Stakeholders and the Mariner Credentialing Program;

(e) Task Statement X-1, Military Education, Training and Assessment for STCW and National Mariner Endorsements;

(f) Task Statement 90 Addendum a, National Model Courses;

(g) Task Statement 101 Addendum b, Review of Coast Guard Forms.

(7) Other items for discussion:

(a) Report on the Mariner Credentialing Program;

(b) USCG Federal Advisory Committee changes due to the Coast Guard Authorization Act of 2018;

(c) Report on National Maritime Center;

(d) Report on International Maritime Organization Activities affecting merchant mariner credentialing; and

(e) Briefings about other on-going U.S. Coast Guard projects related to personnel in the U.S. merchant marine.

(8) Public comment period.

(9) Discussion of Working Group recommendations. The Committee will review the information presented on each issue, deliberate on any recommendations presented by the Working Groups, approve/formulate recommendations and close any completed tasks. Official action on these recommendations may be taken on this date.

(10) Closing remarks/plans for next meeting.

(11) Adjournment of meeting.

A copy of all meeting documentation will be available at https://homeport.uscg.mil/missions/ports-and-waterways/safety-advisory-committees/merpac no later than September 11, 2018. Alternatively, you may contact Mr. Davis Breyer as noted in the FOR FURTHER INFORMATION CONTACT section above.

A public comment period will be held during each Working Group and full Committee meeting concerning matters being discussed. Public comments will be limited to three minutes per speaker. Please note that the public comment periods will end following the last call for comments.

Please contact the individual listed in the FOR FURTHER INFORMATION CONTACT section, to register as a speaker. Please note that the meeting may adjourn early if the work is completed.

The United States is signatory to the International Maritime Organization's International Regulations for Preventing Collisions at Sea, 1972 (72 COLREGS), as amended. The special construction or purpose of some vessels makes them unable to comply with the light, shape, or sound signal provisions of the 72 COLREGS. Under statutory law, however, specified 72 COLREGS provisions are not applicable to a vessel of special construction or purpose if the Coast Guard determines that the vessel cannot comply fully with those requirements without interfering with the special function of the vessel. 1

The owner, builder, operator, or agent of a special construction or purpose vessel may apply to the Coast Guard District Office in which the vessel is being built or operated for a determination that compliance with alternative requirements is justified, 2 and the Chief of the Prevention Division would then issue the applicant a certificate of alternative compliance (COAC) if he or she determines that the vessel cannot comply fully with 72 COLREGS light, shape, and sound signal provisions without interference with the vessel's special function. 3 If the Coast Guard issues a COAC, it must publish notice of this action in the Federal Register . 4

The Chief of Prevention Division, Seventh District, U.S. Coast Guard, certifies that the EAGLE II (O.N. 1294433) is a vessel of special construction or purpose, and that, with respect to the positions of the masthead light, stern light, and sidelights, it is not possible to comply fully with the requirements of the provisions enumerated in the 72 COLREGS, without interfering with the normal operation, construction, or design of the vessel's car deck. The Chief of Prevention Division, Seventh District, U.S. Coast Guard, further finds and certifies that the lights are configured in closest possible compliance with the applicable provisions of the 72 COLREGS. 5

The Chief of Prevention Division, Seventh District, U.S. Coast Guard, certifies that the Q-OCEAN SERVICE (O.N. 1284182) is a vessel of special construction or purpose, and that, with respect to the positions of the sidelights, it is not possible to comply fully with the requirements of the provisions enumerated in the 72 COLREGS, without interfering with the normal operation, construction, or design of the vessel's primary function as a tug. The Chief of Prevention Division, Seventh District, U.S. Coast Guard, further finds and certifies that the lights are configured in closest possible compliance with the applicable provisions of the 72 COLREGS. 6

This notice is issued under authority of 33 U.S.C. 1605(c) and 33 CFR 81.18.

This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A. The Federal Register notice that solicited public comments on the information for a period of 60 days was published on May 24, 2019.

Title of Information Collection: Comprehensive Transactional Forms Supporting FHA's Section 242 Mortgage Insurance Program for Hospitals.

OMB Approval Number: 2502-0602.

Type of Request: Revision.

Form Number: HUD-91070-OHF, HUD-91071-OHF, HUD-91073-OHF, HUD-91111-OHF, HUD- 91725-OHF, HUD-92013-OHF, HUD-92023-OHF, HUD-92070-OHF, HUD-92080- OHF, HUD-92117-OHF, HUD-92205-OHF, HUD-92223-OHF, HUD-92266-OHF, HUD-92322-OHF, HUD-92330-OHF, HUD-92330A-OHF, HUD-92403-OHF, HUD- 92403A-OHF, HUD-92415-OHF, HUD-92422-OHF, HUD-92434-OHF, HUD-92441- OHF, HUD-92442-OHF, HUD-92448-OHF, HUD-92452A-OHF, HUD-92452-OHF, HUD-92455-OHF, HUD-92456-OHF, HUD-92464-OHF, HUD-92466-OHF, HUD- 92476-OHF, HUD-92476A-OHF, HUD-92476B-OHF, HUD-92479-OHF, HUD-92554- OHF, HUD-92576-OHF, HUD-93305-OHF, HUD-94000-OHF, HUD-94001-OHF, HUD-94128-OHF.

Description of the need for the information and proposed use: This collection of information is required specifically for the application and administration of the Department of Housing and Urban Development, Federal Housing Administration Section 242 Hospital Mortgage Insurance Program pursuant to 24 CFR 242, 241, 223(f), and 223(a)(7). The collection is a comprehensive set of HUD documents that are critically needed for processing applications and loan endorsements for FHA mortgage insurance under the Section 242 Hospital Mortgage Insurance Program, for ongoing asset management of such facilities, and other information related to these facilities for loan modifications, construction projects, and physical and environmental reviews.

This information is requested and is used by the Office of Healthcare Facilities (OHF) and Office of Architecture and Engineering (OAE) within FHA's Office of Healthcare Programs (OHP).

The purpose for which the information is being collected by HUD is to review Section 242 applications to determine the eligibility of applicant hospitals for FHA mortgage insurance, underwrite insured hospital loans, ensure that the collateral securing each loan is adequate, capture administrative data, process initial/final endorsement, and manage FHA's hospital portfolio. Additional information related to loan modifications, construction projects, and physical and environmental reviews is collected if applicable.

The information being collected consists of various HUD forms that program participants complete with project specifications, technical descriptions, details, and/or signatures that are utilized by HUD during various stages of the application, underwriting, commitment, closing, and asset management processes involved with the administration of FHA's Section 242 mortgage insurance program.

The information is used by HUD staff for internal review of applications to determine if projects qualify for Section 242 hospital mortgage insurance and to manage and monitor the application, commitment, initial/final endorsement, asset management, and administration processes needed to support hospital projects insured by FHA. Agreements and legal documents are used by HUD staff, lenders, borrowers, construction managers, and depository institutions, when applicable, to process initial/final endorsement of loans. Information reported for ongoing asset management of FHA-insured facilities will be used by HUD staff to monitor and manage risk within the FHA portfolio and ensure ongoing compliance with HUD Program Obligations. Information is also be used by HUD staff to determine whether the Program meets its stated goals and management objectives. The information is collected from lenders/mortgage bankers, borrowers/hospital management officials, attorneys, general contractors/construction managers, architects/engineers, agents and others involved in hospital projects, which may, at times include local government entities and other third parties, as well as HUD staff to allow OHF to manage and monitor the application, commitment, initial/final endorsement, asset management, and administration processes needed to support hospital projects insured by FHA.

This collection is needed to update and renew the current collection that was approved for a 36-month period by OMB on August 19, 2016, with an expiration date of August 31, 2019. Where changes have been made to existing OHF forms, the proposed versions are also presented in both redline/strikeout and unmarked formats. New or unchanged forms are presented in unmarked format. The revised hospital documents can be viewed at: http://portal.hud.gov/hudportal/HUD?src=/federal_housing_administration/healthcare_facilities/section_242/additional_resources/242_docs_2019renewal.

Two new forms are being added to this collection: HUD-92266-OHF (Application for Transfer of Physical Assets) and HUD-92476B-OHF (Escrow Agreement for Proceeds from Partial Release of Collateral). The HUD-92266-OHF form is based on an existing Office of Multifamily form, modified for Section 242-insured hospitals. The application collects the information required for OHF staff to review requests to transfer insured physical assets to new purchasers that will continue to hold the FHA-insured loan. The HUD-92476B-OHF is being added to provide an escrow agreement template for infrequent instances when a borrower sells and requests to release HUD-insured collateral. Both documents are based on existing versions used by the Office of Housing in other mortgage insurance programs but modified to appropriately reflect Section 242 program needs.

HUD-9250-OHF (Funds Authorizations) will be removed from the collection. The document was added to Collection 2502-0602 in a prior submission and was based upon a similar form used for OHP's residential care facility program. The form has proven to be unnecessary for the Section 242 hospital program and will be removed.

Thirty-five of the forty documents within the collection are being renewed with no operational content changes, except for updated burden hour estimates and additional language added to the burden statements to ensure that requirements under 5 CFR 1320.8(b)(3) are met. Additional language (specifically, the phrase “under penalty of perjury”) was also added to clarify fraud warnings and certification for forms with certifications. Revisions are proposed for the HUD-92466-OHF (Regulatory Agreement), HUD-92422-OHF (Financial and Statistical Data for HUD Reporting), and HUD-94000-OHF (Security Instrument) to include edits that were made to clarify current policies and definitions, reflect updated general accepted accounting standards, or to address minor inconsistencies across documents. A summary of the specific changes made to the revised documents is provided below.

HUD-92476B-OHF Escrow Agreement for Proceeds from Partial Release of Collateral. New document used to establish an escrow agreement and escrow account as part of the approval process for the partial release of FHA-insured collateral. Document defines permitted uses of escrowed proceeds, including usage for collateralized property improvements, purchase of equipment, or principal payments of the FHA-insured mortgage. Requires approval of all advances in writing by HUD and the Lender.

HUD-92266-OHF Application for Transfer of Physical Assets. New document based on an existing Office of Multifamily Housing application form for Transfer of Physical Assets transactions, modified for Section 242-insured hospitals.

HUD-92422-OHF Financial and Statistical Data for HUD Reporting. Definitions were updated to be consistent with account names, and a definition for “Allowances for Contractual Deductions and Bad Debt” was added. “Deferred Financing Costs” was moved from the “Limited Use Assets” to the “Long Term Debt and Leases” (previously “Long Term Debt and Capital Leases”) account. “Right of Use Assets” was added to the “Net PPE” account. Some restricted and unrestricted net asset accounts were combined and account names and definitions were updated. A note was added to clarify that “Bad Debt Expense” can be recorded as a separate line item, depending on the accounting reporting standards being used.

HUD-94000-OHF Security Instrument/Mortgage/Deed of Trust. In Section 1 (Definitions), the definition of Patient Accounts Receivables was clarified in the definition of Accounts Receivables. The definition of Personality and Mortgaged Property was revised to add the income or sales distributed from a joint venture.

HUD-92466-OHF Hospital Regulatory Agreement—Borrower. Changes were made to sections of the Regulatory Agreement as follows:

• Section 1 and Section 49 (Definitions). Revised to include definitions found in 24 CFR 242.1 and Handbook 4615.1 to provide clarity. Definitions section from Appendix D was moved to Section 49. Definition of Patient Accounts Receivables was added for Distribution of Assets in Section 18 and Additional Indebtedness in Section 20.

• Section 11—Property and Operations; Encumbrances. Added new item (g) regarding Borrower notification to HUD.

• Section 17—Transactions with Affiliates. Clarified transactions with Affiliates regarding lower of fully allocated cost or market value.

• Section 18—Distribution of Assets. Changed Section 18(b)(v) to reflect financial requirements per 24 CFR 242.1 for the Surplus Cash definition. Included definitions and ratios in Section 49.

• Section 19—Board Review/Business Plan/Consultants' Report. Added “BOARD REVIEW” to title for clarity. In Section 19(c)(iv), removed “pro forma balance sheet” as a deliverable and clarified Business Plan deliverables to HUD for income statement and cash flow analysis. Combined the roles of “Review Consultant” and “Independent Consultant” into one consultant to allow for more timely review and cost savings for Borrower.

• Section 20—Additional Indebtedness. Under Long Term Debt, clarified when HUD consent is needed versus notification and timing; added CEO to parties eligible to submit documentation for notification; and added new section 20(a)(vi) to specify Borrower agreement to assets becoming part of the Mortgaged Property at HUD's discretion upon release of a lien. Under Unsecured Short-Term Debt, clarified when HUD consent is needed versus notification and timing and added CEO to parties eligible to submit documentation for notification. Added Section 20(c) for Lines of Credit to apply to short-term and long-term lines of credits secured by accounts receivable.

• Section 21—Successor Clause. Removed Section 21(a). Clarified successor clauses and definitions to emphasize HUD's option for approval.

• Section 29—Permits and Approvals. Added new Section 29(e) regarding Borrower's responsibility to report accrediting organization or entity findings to HUD upon occurrence, along with action plan requirements.

• Section 36—Actions Requiring Prior Written Approval of HUD. Revised 36(g) to clarify when HUD approval is required for actions impacting collateral under the FHA-insured mortgage. Added new item 36(q) for establishing, developing, or organizing a joint venture.

HUD received one comment regarding collection 2502-0602 during the 60-day comment period that closed on July 23, 2019. The comment addressed an issue with the link to the posted documents online not working correctly. HUD corrected the issue and responded to this comment directly.

Respondents (i.e. affected public): Lenders/mortgage bankers, borrowers/hospital management officials, attorneys, general contractors/construction managers, architects/engineers, agents and others involved in hospital projects, which may, at times include local government entities and other third parties, as well as other agents involved in hospital projects seeking FHA mortgage insurance.

Estimated Number of Respondents: 485.

Estimated Number of Responses: 1,069.

Frequency of Response: 2.2.

Average Hours per Response: 74.

Total Estimated Burdens: 79,426.

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.

This notice is published in the exercise of authority delegated by the Secretary of the Interior to the Assistant Secretary—Indian Affairs by part 209 of the Departmental Manual, and is published to comply with the requirement of 25 CFR 151.12(c)(2)(ii) that notice of the decision to acquire land in trust be promptly published in the Federal Register .

On July 12, 2019, the Assistant Secretary—Indian Affairs issued a decision to accept land in trust for the Forest County Potawatomi Community, Wisconsin under the authority of Section 5 of the Indian Reorganization Act of 1934 (48 Stat. 984).

An extension to an existing tribal-state Class III gaming compact does not require approval by the Secretary if the extension does not modify any other terms of the compact. 25 CFR 293.5. The Pyramid Lake Paiute Tribe of the Pyramid Lake Reservation and the State of Nevada have reached an agreement to extend the expiration date of their existing Tribal-State Class III gaming compact to February 23, 2021. This publishes notice of the new expiration date of the compact.

The lessee requested reinstatement after the lease automatically terminated for untimely payment of rent. The lessee agrees to the new lease terms for rentals and royalties of $10 per acre, or fraction thereof, per year, and 16 2/3 percent, respectively. The lessee paid the required $500 administrative fee for lease reinstatement and the $151 cost of publishing this notice. The lessee met the requirements for reinstatement of the lease per Sec. 31(d) and (e) of the Mineral Leasing Act of 1920 (30 U.S.C. 188). The BLM considered the impacts of reinstatement of the lease in Environmental Assessment DOI-BLM-CO-N05-2017-0035, and issued a Finding of No Significant Impact. The BLM proposes to reinstate the lease effective April 1, 2016, under amended lease terms and the increased rental and royalty rates described above.

The lease parcel is located along portions of Volunteer Boulevard, Welpman Way, and Gilespie Street in the City of Henderson and is described as:

The Calvary Chapel filed an application to develop the site as a 16,000-square foot K-12 school building to include classrooms, offices, nursery, kitchen, restrooms, utility/storage rooms, and a lobby. A 20,000-square foot church building will include a worship center, offices, lobby, nursery, kitchen, restrooms, and utility/storage rooms. Buildings will be modular and erected or delivered on foundations prepared within the site. Onsite improvements include lighted paved parking, access drives, sidewalks, landscaping, walkways, meditation path, landscaping, play/recreation areas, and gathering/multi-use areas. Offsite improvements will be developed as required by governing agencies.

The play area will support uses such as volleyball, basketball, recess activities, and fair-weather gatherings. The meditation paths will provide a natural environment, enhanced by dispersed seating and desert landscape screening. This area may also be used for outdoor education such as plant identification or interpretation. The play area and meditation paths are planned for day use activities. Additional information pertaining to this publication, plan of development, and site plan is located in casefile N-95930, which is available for review at the BLM Las Vegas Field Office at the above address.

The lands are not needed for any Federal purposes, and do not provide access to federal lands used for recreation. Lease or conveyance of the lands for recreational or public purposes use is consistent with the BLM Las Vegas Resource Management Plan dated October 5, 1998, and would be in the public interest. The Calvary Chapel has not applied for more than the 6,400-acre limitation for recreation uses in a year, nor more than 640 acres for each of the programs involving public resources other than recreation.

All interested parties will receive a copy of this notice once it is published in the Federal Register . A copy of the Notice with information about this realty action will publish in the newspaper of local circulation once a week for three consecutive weeks. The regulations at 43 CFR 2741 addressing requirements and procedures for conveyances under the R&PP Act do not require a public meeting.

Upon publication of the Notice in the Federal Register , the lands will be segregated from all other forms of appropriation under public lands laws, except for the lease or conveyance under the R&PP Act and leasing under the mineral leasing laws. The segregation effect shall terminate upon issuance of the lease, upon final rejection of the application, or 18 months from the date of this notice, whichever occurs first.

The lease or conveyance of the land, when issued, will be subject to the following terms, conditions, and reservations:

1. A right-of-way thereon for ditches and canals constructed by the authority of the United States Act of August 30, 1890 (26 Stat. 391; 43 U.S.C. 945).

2. Provisions of the R&PP Act and to all applicable regulations of the Secretary of the Interior.

3. All mineral deposits in the land so patented, and the right to prospect for, mine, and remove such deposits from the same under applicable law and regulations as established by the Secretary of the Interior are reserved to the United States, together with all necessary access and exit rights.

4. Lease or conveyance of the parcel is subject to valid existing rights.

5. 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.

6. Any other reservations that the authorized officer determines appropriate to ensure public access and proper management of Federal lands and interests therein.

Any lease and conveyance will also contain any terms or conditions required by law (including, but not limited to, any terms or conditions required by 43 CFR 2741.4), and will contain an appropriate indemnification clause protecting the United States from claims arising out of the lessee's/patentee's use, occupancy, or operations on the leased/patented lands. It will also contain any other terms and conditions deemed necessary and appropriate by the Authorized Officer.

Interested persons may submit comments involving the suitability of the land for development of a church and K-12 school in the City of Henderson. 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 submit comments regarding the specific use proposed in the application, plan of development and management, and whether the BLM followed proper administrative procedures in reaching the decision to lease and convey under the R&PP Act.

Before including your address, phone number, email address, or other personally identifiable information in any comment, be aware that your entire comment including your personally identifiable information may be made publicly available at any time. While you can ask the BLM in your comment to withhold your personally identifiable information from public review, we cannot guarantee that we will be able to do so.

Only written comments submitted to the Assistant Field Manager, Division of Lands, BLM Las Vegas Field Office, will be considered properly filed. Any adverse comments will be reviewed by the BLM Nevada State Director or other authorized official of the Department of the Interior, who may sustain, vacate, or modify this realty action.

In the absence of any adverse comments, the decision will become effective on October 21, 2019. The lands will not be available for lease and conveyance until after the decision becomes effective.

Authority: 43 CFR 2741.5

The Commission instituted this investigation on October 25, 2017, based on a complaint filed by FUJIFILM Corporation of Tokyo, Japan and FUJIFILM Recording Media U.S.A., Inc. of Bedford, Massachusetts (collectively, “Fujifilm”). 82 FR 49421 (Oct. 25, 2017). The complaint alleged violations of 19 U.S.C. 1337 (“Section 337”) through the importation into the United States, sale for importation, or sale in the United States after importation of certain magnetic data storage tapes and cartridges that infringe one or more of the asserted claims of U.S. Patent Nos. 6,630,256 (“the ′256 patent”), 6,835,451 (“the ′451 patent”), 7,011,899 (“the ′899 patent”), 6,462,905 (“the ′905 patent”), and 6,783,094 (“the ′094 patent”). Id. The ′094 patent was later withdrawn and terminated from the investigation. See Order No. 11 (Mar. 19, 2018), not rev'd, Comm'n Notice (Apr. 17, 2018).

The notice of investigation named Sony Corporation of Tokyo, Japan; Sony Storage Media Solutions Corporation of Tokyo, Japan; Sony Storage Media Manufacturing Corporation of Miyagi, Japan; Sony DADC US Inc. of Terre Haute, Indiana; and Sony Latin America Inc. of Miami, Florida (collectively, “Sony”) as respondents. 82 FR at 49421-22. The Office of Unfair Import Investigations (“OUII”) was also named a party to the investigation. Id.

The presiding administrative law judge (“ALJ”) held an evidentiary hearing on June 25-29, 2018, and issued his final initial determination (“ID”) and recommended determination (“RD”) on October 25, 2018. The ID finds that Sony violated Section 337 with respect to the ′256 and ′899 patents but not the ′905 or ′451 patents. The RD recommends that the Commission issue a limited exclusion order and cease and desist orders accordingly.

The Commission determined to review the subject ID in part. 84 FR 10532 (Mar. 21, 2019). On June 6, 2019, the Commission issued its final determination, in which it concluded that Sony violated Section 337 by infringing the ′256 and ′899 patents and issued a limited exclusion order and cease and desist orders accordingly. Comm'n Op. (June 6, 2019); 84 FR 27358 (June 12, 2019).

On July 25, 2019, Fujifilm and Sony filed a Joint Petition of Complainants and Respondents to Rescind Limited Exclusion Order and Cease and Desist Orders in the above-referenced investigation. The parties assert that rescission is warranted due to a settlement agreement and patent cross-license, pursuant to 19 U.S.C. 1337(k) and 19 CFR 210.76(a). On August 5, 2019, OUII filed a response in support of the joint petition and rescission of the remedial orders in the above-captioned investigation.

Upon review of the parties' submissions, the Commission has determined to grant the subject joint petition and rescind the limited exclusion order and cease and desist orders issued in this investigation. The Commission finds that the settlement fully resolves the dispute between the parties concerning the subject matter of the investigation. The Commission also finds that the joint petition complies with the requirements of Commission Rule 210.76, 19 CFR 210.76.

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).

The Commission instituted this investigation on June 29, 2018, based on a complaint filed on behalf of Bose Corporation of Framingham, Massachusetts (“Bose”). 83 FR 30,776 (Jun. 29, 2018). The complaint alleges violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337 (“section 337”) based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain earpiece devices and components thereof by reason of infringement of one or more claims of U.S. Patent Nos. 9,036,852 (“the '852 patent”); 9,036,853 (“the '853 patent”); 9,042,590 (“the '590 patent”); 8,311,253 (“the '253 patent”); 8,249,287 (“the '287 patent”); and 9,398,364 (“the '364 patent”). The '852, '853, '590, '253, and '287 patents are herein referred to as the StayHear® Patents. The complaint further alleges that an industry in the United States exists as required by section 337.

The notice of investigation named fourteen respondents: (1) 1MORE USA, Inc. of San Diego, California; (2) APSkins of Seattle, Washington; (3) Beeebo Online Limited (“Beeebo”) of North Las Vegas, Nevada; (4) iHip of Edison, New Jersey; (5) LMZT LLC of Brooklyn, New York; (6) Misodiko of ShenZhen, GuangDong, China; (7) Phaiser LLC of Houston, Texas; (8) Phonete of Shenzhen, China; (9) REVJAMS of New York, New York; (10) SMARTOMI Products, Inc. of Ontario, California; (11) Spigen, Inc. of Irvine, California; (12) Sudio AB of Stockholm, Sweden; (13) Sunvalley Tek International, Inc. of Fremont, California; and (14) TomRich of Shenzhen, China. The Office of Unfair Import Investigations (“OUII”) was also named as a party in this investigation.

On October 4, 2018, Bose moved to amend the notice of investigation and for leave to file an amended complaint in order, among other things, (i) to correct the name of respondent iHip to Zeikos, Inc.; and (ii) to correct the name and address of respondent SMARTOMI Products, Inc. to V4ink, Inc. On October 29, 2018, the ALJ granted the motion. See Order No. 10 (Oct. 29, 2018), not rev'd by Comm'n Notice (Nov. 23, 2018); 83 FR 61168 (Nov. 28, 2018); 83 FR 62900 (Dec. 6, 2018). Bose filed and served its amended complaint on February 21, 2019.

During the course of the investigation, Bose settled with the following respondents: APSkins; Zeikos, Inc.; LMZT LLC; Spigen, Inc.; Sudio AB; and Sunvalley Tek International, Inc. See Order Nos. 8 and 9 (Oct. 19, 2018), not rev'd by Comm'n Notice (Nov. 9, 2018); Order No. 11 (Oct. 29, 2018), not rev'd by Comm'n Notice (Nov. 27, 2018); Order No. 12 (Nov. 26, 2018), not rev'd by Comm'n Notice (Dec. 19, 2018); Order Nos. 14 and 15 (Feb. 21, 2019), not rev'd by Comm'n Notice (Mar. 11, 2019). In addition, with the exception of Spigen, Inc., consent orders were issued against all of these respondents. Id. Thus, the investigation has been terminated with respect to these six respondents.

Five other respondents have been found in default pursuant to Commission Rule 210.16, 19 CFR 210.16: Beeebo; Misodiko; Phaiser LLC; V4ink, Inc.; and TomRich (collectively, “the Defaulting Respondents”). See Order No. 7 (Sep. 20, 2018); Order No. 13 (Dec. 11, 2018), not rev'd by Comm'n Notice (Dec. 21, 2018).

On February 8, 2019, Bose moved for summary determination of a violation of section 337. Bose filed a corrected motion on March 1, 2019. Thereafter, Bose filed several replacement exhibits and a supplemental index.

The remaining three respondents, 1MORE USA, Inc., Phonete, and REVJAMS (collectively “the Non-Participating Respondents”), have not submitted any response, appeared, or otherwise participated in the investigation despite being served with the complaint or amended complaint, and the motion for summary determination of violation. The three Non-Participating Respondents and the five Defaulting Respondents were the subject of Bose's motion for summary determination of a violation of section 337. On March 22, 2019, OUII filed a response supporting Bose's motion in substantial part and supporting the requested remedy of a general exclusion order.

On June 28, 2019, the ALJ issued the subject ID and his Recommended Determination (“RD”) on remedy and bonding. The ID grants in part Bose's motion for summary determination of a violation of section 337. Specifically, the ALJ found, inter alia, that Bose established that the importation requirement is satisfied as to each Defaulting Respondent and Non-Participating Respondent and each accused product; that other than infringement of claim 7 of the '852 patent with respect to the Misodiko, Phonete, and TomRich products, Bose established infringement of claims 1 and 7 of the '852 patent; claims 1 and 8 of the '853 patent; claims 1 and 6 of the '590 patent; claim 1 of the '253 patent; claims 1, 7, and 8 of the '287 patent; and claims 1 and 11 of the '364 patent; and that Bose satisfied the domestic industry requirement for each asserted patent. In addition, the ALJ recommended that the Commission issue a general exclusion order, cease and desist orders, and impose a 100 percent bond during the period of Presidential review.

No petitions for review were filed.

Having reviewed the record of this investigation, including the ID, the Commission has determined to review the ID in part. Specifically, the Commission has determined to review the following findings, which were based on the substantial, reliable, and probative evidence standard: (1) The ID's finding that Bose has established infringement of claim 7 of the '852 patent with respect to Beeebo's Dodocool Earhooks, and, on review, reverse that finding; (2) the ID's finding that Bose has satisfied the economic prong of the domestic industry requirement under sections 337(a)(3)(A) and (B) with respect to the '364 patent; and (3) the ID's finding that Bose has satisfied the economic prong of the domestic industry requirement under section 337(a)(3)(C) with respect to the asserted patents, and, on review, take no position on that finding. The Commission has determined not to review the remainder of the ID. Accordingly, the Commission finds a violation of section 337 by reason of infringement of claims 1 and 7 of the '852 patent; claims 1 and 8 of the '853 patent; claims 1 and 6 of the '590 patent; claim 1 of the '253 patent; and claims 1, 7, and 8 of the '287 patent; and the satisfaction of the domestic industry requirement under sections 337(a)(3)(A) and (B) with respect to the StayHear® Patents.

The parties are requested to brief their positions on only the following issue under review.

1. The record evidence shows that Bose aggregated its domestic investments in Fiscal Year 2018 for domestic industry products that practice the StayHear® Patents and the '364 patent to establish a domestic industry under sections 337(a)(3)(A) and (B). Bose, however, relies on a subset of its domestic industry products to satisfy the domestic industry requirement with respect to the '364 patent. Please provide an appropriate allocation of the domestic investments and discuss whether such allocated investments establish a domestic industry under sections 337(a)(3)(A) and (B) with respect to the '364 patent.

In connection with the final disposition of this investigation, the Commission may (1) issue an order that could result in the exclusion of the subject articles from entry into the United States, and/or (2) issue cease and desist order(s) that could result in the respondent(s) being required to cease and desist from engaging in unfair acts in the importation and sale of such articles. Accordingly, the Commission is interested in receiving written submissions that address the form of remedy, if any, that should be ordered. If a party seeks exclusion of an article from entry into the United States for purposes other than entry for consumption, the party should so indicate and provide information establishing that activities involving other types of entry either are adversely affecting it or likely to do so. For background, see Certain Devices for Connecting Computers via Telephone Lines, Inv. No. 337-TA-360, USITC Pub. No. 2843, Comm'n Op. at 7-10 (Dec. 1994). In addition, if a party seeks issuance of any cease and desist orders, the written submissions should address that request in the context of recent Commission opinions, including those in Certain Arrowheads with Deploying Blades and Components Thereof and Packaging Therefor, lnv. No. 337-TA-977, Comm'n Op. (Apr. 28, 2017) and Certain Electric Skin Care Devices, Brushes and Chargers Therefor, and Kits Containing the Same, lnv. No. 337-TA-959, Comm'n Op. (Feb. 13, 2017). Specifically, if Complainant seeks a cease and desist order against a respondent, the written submissions should respond to the following requests:

1. Please identify with citations to the record any information regarding commercially significant inventory in the United States as to each respondent against whom a cease and desist order is sought. If Complainant also relies on other significant domestic operations that could undercut the remedy provided by an exclusion order, please identify with citations to the record such information as to each respondent against whom a cease and desist order is sought.

2. ln relation to the infringing products, please identify any information in the record, including allegations in the pleadings, that addresses the existence of any domestic inventory, any domestic operations, or any sales-related activity directed at the United States for each respondent against whom a cease and desist order is sought.

3. Please explain with citation to the record whether respondents 1MORE USA, Inc., Phonete, and REVJAMS satisfy the requirements of subsections (A)-(E) of section 337(g)(1). See SD at 4.

If the Commission contemplates some form of remedy, it must consider the effects of that remedy upon the public interest. The factors the Commission will consider include the effect that an exclusion order would have on (1) the public health and welfare, (2) competitive conditions in the U.S. economy, (3) U.S. production of articles that are like or directly competitive with those that are subject to investigation, and (4) U.S. consumers. The Commission is therefore interested in receiving written submissions that address the aforementioned public interest factors in the context of this investigation.

If the Commission orders some form of remedy, the U.S. Trade Representative, as delegated by the President, has 60 days to approve or disapprove the Commission's action. See Presidential Memorandum of July 21, 2005, 70 FR 43251 (July 26, 2005). During this period, the subject articles would be entitled to enter the United States under bond, in an amount determined by the Commission and prescribed by the Secretary of the Treasury. The Commission is therefore interested in receiving submissions concerning the amount of the bond that should be imposed if a remedy is ordered.

Written Submissions: Parties to the investigation, interested government agencies, and any other interested parties are encouraged to file written submissions on the issues of remedy, the public interest, and bonding. Such submissions should address the recommended determination by the ALJ on remedy and bonding.

Complainant and OUII are also requested to submit proposed remedial orders for the Commission's consideration. Complainant is further requested to state the dates that the asserted patents expire, the HTSUS numbers under which the accused products are imported, and to supply the identification information for all known importers of the products at issue in this investigation. The written submissions and proposed remedial orders must be filed no later than close of business on August 28, 2019. Reply submissions must be filed no later than the close of business on September 5, 2019. No further submissions on these issues will be permitted unless otherwise ordered by the Commission.

Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit 8 true paper copies to the Office of the Secretary by noon the next day pursuant to Commission Rule 210.4(f), 19 CFR 210.4(f). Submissions should refer to the investigation number (Inv. No. 337-TA-1121) in a prominent place on the cover page and/or the first page. ( See Handbook for Electronic Filing Procedures, https://www.usitc.gov/secretary/documents/handbook_on_filing_procedures.pdf ). Persons with questions regarding filing should contact the Secretary, (202) 205-2000.

Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment. See 19 CFR 201.6. Documents for which confidential treatment by the Commission is properly sought will be treated accordingly. A redacted non-confidential version of the document must also be filed simultaneously with any confidential filing. All information, including confidential business information and documents for which confidential treatment is properly sought, submitted to the Commission for purposes of this investigation may be disclosed to and used: (i) By the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel, solely for cybersecurity purposes. All contract personnel will sign appropriate nondisclosure agreements. All nonconfidential written submissions will be available for public inspection at the Office of the Secretary and on EDIS.

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).