Federal Register Vol. 80, No.187,

Dry Creek Vista Picnic Site; Fay Canyon Vista Trailhead. These locations are extremely popular with over 500 visitors per day during spring and fall using the sites for recreation. The amenities at these sites are critical both for public services and for resource protection. The general area is rich in archaeological remains and also has sensitive soils. The developed sites have adequate amenities to mitigate resource damage which can accompany such high recreation pressure. The fee revenue will be used to maintain the sites and provide public security: pump the vault toilet, provide janitorial service, remove garbage, provide interpretation, repair signs and parking surfaces and support Forest Service patrols in the area for visitor assistance and security. Dry Creek site: T.17N., R.5E., Sec. 3, NE1/4NW1/4N1/2; Fay Canyon site: T.17N., R.5E., Sec.31, GSRBM. These two new fee proposals are part of a larger fee modification proposal on the Coconino National Forest.

The full fee proposal can be found on the Coconino (or Red Rock) National Forest Web site at: http://www.fs.usda.gov/main/coconino/landmanagement/planning.

The NTAP is a joint advisory panel of the Mid-Atlantic and New England Fishery Management Councils. It is composed of Council members, fishing industry, academic, and government and non-government fisheries experts who will provide advice and direction on the conduct of trawl research. The NTAP was established to bring commercial fishing, fisheries science, and fishery management professionals in the northeastern US together to identify concerns about regional research survey performance and data, to identify methods to address or mitigate these concerns, and to promote mutual understanding and acceptance of the results of this work among their peers and in the broader community. Topics to be discussed at the meeting include: review NTAP Charter, review NEFSC Trawl Survey, and discuss additional trawl research/complementary surveys.

The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aid should be directed to M. Jan Saunders, (302) 526-5251, at least 5 days prior to the meeting date.

1. Project Site and Background Information. The Proposed Action is located within the southern Santa Clara County, approximately 25 miles southeast of San Jose, in the communities of Morgan Hill and San Martin. The project consists of seven reaches (4, 5, 6, 7A, 7B, 8, and 14) of Llagas Creek, East Little Llagas Creek, and West Little Llagas Creek above Buena Vista Avenue. The total length of the project area is approximately 13.1 miles; 6.1 miles of which are along the main branch of Llagas Creek, 3.3 miles along West Little Llagas Creek, and 2.4 miles along a tributary of Llagas Creek known as East Little Llagas Creek. An additional 1.3 miles of new diversion channel would be constructed along West Little Llagas Creek to Llagas Creek. On the north, the physical limits of the project are at the creek's intersection with Llagas Road on West Little Llagas Creek in Morgan Hill and in the south, the project limits area approximately 800 feet below the creek's intersection with Buena Vista Avenue in Gilroy.

(a) Background. In 1982 the first EIS for the Upper Llagas Project was prepared by the National Resources Conservation Services (NRCS) as the lead agency. The downstream portion of the project, from the confluence with the Pajaro River to Buena Vista Avenue, was completed in 1996. However, due to the federal Endangered Species Act listing of steelhead trout in 1997, the changed environmental condition prompted an update to the existing 1982 EIS. NRCS was lacking funding to complete the upstream portion of the Project, so under the Water Resources Development Act of 1999, the project was transferred to the Corps to complete. Corps Civil Works hired an environmental consultant in 2007 to begin preparation of the current Project EIS.

(b) Purpose and Need. The overall project purpose is to manage flood risk within the Upper Llagas Creek Watershed and provide flood protection for residents, businesses, and infrastructure in the City of Morgan Hill, community of San Martin, and the sphere of influence of the City of Gilroy. The Proposed Action would increase flood protection for up to a one percent flood exceedance event in the City of Morgan Hill (Reaches 8, 7A, and 7B); assure no additional flooding is induced on Llagas Creek by the upstream modifications along the reaches downstream from Morgan Hill (Reaches 6, 5, and 4), and provides a ten percent exceedance capacity for the semi-urban area along East Llagas Creek (Reach 14).

(c) Proposed Action. The Santa Clara Valley Water District proposes 44.82 acres of temporary impacts and 3.81 acres of permanent impacts to jurisdictional waters of the United States. Flood management features and proposed activities include widening and deepening the channel in all reaches; construction of an underground concrete tunnel beneath Nob Hill to bypass flood flows; construction of a sinuous low-flow channel, construction of access roads along the top of bank in all reaches; aquatic habitat enhancement in reaches 4, 5, 6, and 7A; installation of culverts at two tributary confluences within reach 6 and three tributary confluences in reach 14; construction of a 1.25-mile long earthen diversion channel on West Little Llagas Creek (reach 7A); exhuming of buried bridge crossings in reach 7A; replacement of culverts at four road crossing locations in reach 7B; and removal of a cinder block/brick wall at the upstream project limit and removal of sediment and debris for all culverts and beneath the Hillwood Lane bridge crossing in reach 8.

2. Alternatives. Alternatives to the Proposed Action initially being considered include:

(a) NRCS Alternative: The NRCS Alternative would provide an increased level of flood management for urban areas, specifically: 1 percent flood in Morgan Hill (Reaches 8, 7A, and 7B); 10-percent flood management for the semi-urban area around East Little Llagas Creek (Reach 14); and, avoid induced flooding elsewhere on Llagas Creek (Reaches 6, 5, and 4) due to upstream improvements.

(b) Culvert/Channel Alternative: The Culvert/Channel Alternative would eliminate the need for channel deepening and widening through residential properties, as proposed for the NRCS Alternative between West Main Avenue and West 2nd Street in Reach 8.

(c) Reach 6 Bypass Alternative: The Reach 6 Bypass Alternative would construct a high flow bypass channel between Reach 6 of Llagas Creek and Reach 14 of East Little Llagas Creek. The bypass channel in Reach 6 would intersect with U.S. Highway 101. Therefore, construction of new bridges under the existing north and south bound lanes of the existing U.S. Highway 101 would be required to accommodate the bypass channel. A culvert would also be required under Murphy Road. Reach 14 would need to be enlarged (deeper and wider) to a greater extent than under the other alternatives to maintain a 10-year flood capacity, while preventing induced flooding from the upstream improvements. The bypass would be designed so that no flood capacity improvements would be needed along the Llagas Creek section of Reach 6 downstream from the bypass channel or Reach 5. A hydraulic diversion structure would be required within Llagas Creek upstream to divert high flows into the bypass channel, and which would also allow the existing range of lower flows to continue downstream in Reach 6. In Reach 8 this alternative is exactly same as the design of the Tunnel Alternative, including the construction of a tunnel and the sediment detention basin.

(d) No Action: The “No Action” alternative is one that results in no action requiring a Department of the Army permit.

3. Draft EIS Scoping Process.

(a) The Corps is furnishing this notice to: (1) Advise other Federal and state agencies, affected Tribes, and the public of our intentions; (2) announce the initiation of a 30-day scoping period; and (3) obtain suggestions and information on the scope of issues and alternatives to be included in the Draft EIS. The Corps invites comments from all interested parties to ensure that the full range of issues related to the permit request is addressed and that all significant issues are identified. We will accept written comments until 30 days after the date of publication of this notice.

(b) Significant issues to be analyzed in the Draft EIS include: Aesthetics/visual quality, agricultural resources, air quality, biological resources, cultural resources, cumulative impacts, environmental justice, flood protection, geology/soils, growth inducement, land use/planning, noise/vibration, public health and safety, public services/utilities, recreation, socioeconomics, threatened and endangered species, traffic/circulation, water resources including wetlands, and other issues identified through scoping, public involvement, and interagency coordination.

(c) The Corps will conduct an environmental review of the Proposed Action in accordance with the requirements of NEPA, 1969 as amended, (42 U.S.C. 4321 et seq.) and its implementing regulations (40 Code of Federal Regulations, Section 1500 et seq.), Corps Procedures for Implementing NEPA (33 Code of Federal Regulations, Section 230 et seq.), and the NEPA Implementation Procedures for the Regulatory Program (Appendix B of 33 CFR part 325), as well as other appropriate federal laws and regulations, policies, and procedures of the Corps for compliance with those regulations. The Proposed Action, through the Corps permit review process, will require consultation under Section 7 of the Endangered Species Act and Section 106 of the National Historic Preservation Act. Additionally, the proposed action would involve evaluation for compliance with the Section 404(b)(1) Guidelines of the Clean Water Act; the Magnuson-Stevens Fishery Conservation and Management Act; Water Quality Certification pursuant to Section 401 of the Clean Water Act; and certification of state lands, easements and right of ways.

4. Scoping Workshops. Previous project scoping workshops were held on October 25, 2012 and on November 14, 2001 despite scoping workshops as being optional, but recommended. No additional scoping workshops are proposed for this Project.

5. Availability of the Draft EIS. The Corps currently expects the Draft EIS to be made available to the public in December 2015. A public meeting will be held during the public comment period for the Draft EIS. Written comments will be accepted at the meeting.

On June 2, 2014, we published in the Federal Register (79 FR 31315) a final waiver and extension for the current 36-month grant projects under the Literacy Information and Communication System (LINCS) Regional Professional Development Centers (RPDC) program in which the Secretary waived the restriction against project period extensions involving the obligation of additional Federal funds and extended for an additional 12 months the project period of the four LINCS RPDC grants. The Secretary took this action because we did not believe that it was in the public interest to hold a LINCS RPDC competition for FY 2014, (through September 30, 2015), the same year in which the Department's LINCS resource collection contract and the LINCS technical services contract would end. This one-year extension of the LINCS RPDC project period through FY 2014 ensured seamless technical assistance service delivery to our adult education customers.

On July 24, 2015, we published in the Federal Register (80 FR 44088) (July 2015 notice) a proposed waiver of 34 CFR 75.261(a) and (c)(2), which restricts project period extensions involving the obligation of additional Federal funds, as it applies to the LINCS RPDC. The Secretary also proposed in the July 2015 notice to extend the project period of LINCS RPDC grants for an additional 12 months to enable the four current LINCS RPDC grantees that received awards under the FY 2011 competition to seek a continuation award for one additional year through FY 2015 (through September 30, 2016), with FY 2014 funds, in accordance with the transition authority under section 503(c) of the Workforce Innovation and Opportunity Act (WIOA), 29 U.S.C. 3343(c), which grants the Secretary broad discretion to take appropriate action to provide for the orderly transition from the prior Adult Education and Family Literacy Act (AEFLA) (20 U.S.C. 9201 et seq.) to AEFLA as authorized under WIOA. The Secretaries of Education and Labor have published proposed rules implementing WIOA and are also developing guidance for the State and local grantees that implement WIOA programs, including AEFLA. We did not believe that it would be in the public interest to hold a LINCS RPDC competition during a period of significant change for State grantees transitioning to new program requirements under WIOA, as this is a time when support from the four experienced LINCS RPDC grantees would be particularly critical to maintaining needed technical assistance and professional development for State grantees and adult educators.

There are no substantive differences between the proposed and final waivers and extensions.

Public Comment: In the July 2015 notice, the Secretary invited comments about the potential effect that this waiver and extension of the project period would have on LINCS RPDCs and on applicants that may be eligible to apply for grant awards under any new LINCS RPDC notice inviting applications, should there be one. The July 2015 notice contained background information and our reasons for proposing the waiver and extension of the project period.

We received 12 comments in response to our proposal, one of which did not address the proposed waiver and extension. Generally, we do not address comments that raise concerns not related to the proposed waiver and extension.

Comment: Each of the 11 commenters who addressed the proposed waiver and extension: Supported it, discussed the benefits and accomplishments of current LINCS RPDC projects, and stated that an extension of the current project period would allow grantees to continue to provide quality professional development during a period of transition from the requirements of the prior AEFLA to the new requirements of AEFLA under WIOA.

Response: We agree with the 11 commenters that extending the current LINCS RPDC grant period will allow current LINCS RPDC grantees to request continuation awards with which they could (1) continue to work toward accomplishing the goals and objectives stated in their 2011 LINCS RPDC grant applications, and (2) provide quality professional development during a period of transition from the requirements of the prior AEFLA to the requirements of AEFLA under WIOA.

Change: None.

The Administrative Procedure Act (APA) requires that a substantive rule must be published at least 30 days before its effective date, except as otherwise provided for good cause (5 U.S.C. 553(d)(3)). The Secretary has determined that a delayed effective date is unnecessary and contrary to the public interest. It is unnecessary because we received only 11 public comments on this action, all of which supported our proposal and we have not made any substantive changes to the proposal. It is contrary to public interest because we would not be able to make timely continuation grants to the four affected entities with the delay. Therefore, the Secretary waives the APA's delayed effective date provision for good cause.

The Secretary certifies that the waiver and extension and the activities required to support an additional year of funding will not have a significant economic impact on a substantial number of small entities.

The small entities that will be affected by this waiver and extension are the four currently-funded LINCS RPDC grantees and any potential applicants for LINCS RPDC grants in FY 2015.

The Secretary further certifies that the waiver and extension will not have a significant economic impact on these LINCS RPDC entities because the waiver and extension impose minimal compliance costs to extend projects already in existence, and the activities required to support the additional year of funding will not impose additional regulatory burdens or require unnecessary Federal supervision. Furthermore, the costs of carrying out these activities could be paid for with program funds.

This final waiver and extension does not contain any information collection requirements.

The LINCS RPDC is subject to Executive Order 12372 and the regulations in 34 CFR part 79. One of the objectives of the Executive order is to foster an intergovernmental partnership and a strengthened federalism. The Executive order relies on processes developed by State and local governments for coordination and review of proposed Federal financial assistance. This document provides early notification of our specific plans and actions for this program.

Accessible Format: Individuals with disabilities can obtain this document in an accessible format (e.g., braille, large print, audiotape, or compact disc) on request to the contact person listed under FOR FURTHER INFORMATION CONTACT.

Electronic Access to This Document: The official version of this document is the document published in the Federal Register. Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.thefederalregister.org/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register, in text or Adobe Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at this site.

You may also access documents of the Department published in the Federal Register by using the article search feature at www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

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.

Abstract: In the context of the Clean Air Act (42 U.S.C. 1857), section 114 authorizes the Administrator of EPA to require any person who owns or operates any emission source or who is subject to any requirements of the Act to: (1) Establish and maintain records, (2) make reports, install, use, and maintain monitoring equipment or method, (3) sample emissions in accordance with EPA prescribed locations, intervals and methods, and (4) provide information as may be requested. EPA's regional offices use the information collected to ensure that public health continues to be protected from the hazards of radionuclides by compliance with health based standards. This information is required for those facilities meeting the definition of each Subpart. EPA's compliance monitoring activities vary widely. EPA could issue a letter requesting information about compliance or could conduct a full-scale investigation, including on site inspections. The information required to be submitted is not confidential in nature.

Respondents/affected entities: The NAICS Codes of facilities associated with the activity of the respondents are: (1) Elemental Phosphorous 325188, (2) Phosphogypsum Stacks 212392, (3) Underground Uranium Mines 212291, and (4) Uranium Mill Tailings 212291.

Respondent's obligation to respond: Mandatory.

Estimated number of respondents: 20 (total).

Frequency of response: Initially (Once), Annually, Random (Occasionally)

Total estimated burden: 3,000 hours (per year). Burden is defined at 5 CFR 1320.03(b)

Total estimated cost: $500,000, which includes $300,000 in annualized capital and O&M costs.

On May 27, 2015, the Board requested comment on proposed enhancements to the Reserve Banks' FedACH® SameDay Service (FedACH SameDay Service).1 The proposed enhancements were intended to align the existing FedACH SameDay Service with amendments to NACHA's Operating Rules and Guidelines that were approved by NACHA membership on May 19, 2015 (amended operating rules).2

The ACH network serves as a ubiquitous, nationwide mechanism for processing batch-based credit and debit transfers electronically. The private sector and the Federal Reserve jointly developed the ACH network as an electronic alternative to checks, the growth of which in the late 1960s and early 1970s was creating operational and cost burdens. Currently, the ACH network consists of two network operators: The Reserve Banks, through FedACH, and The Clearing House (TCH), through the Electronic Payments Network (EPN). Both operators provide services to enable ODFIs to originate and RDFIs to receive ACH transactions. The Reserve Banks and TCH work together to exchange inter-operator ACH payments in which the ODFI and RDFI are served by different operators.

The ACH network is governed by the rules of the ACH operators, which generally incorporate the NACHA Operating Rules and Guidelines adopted by NACHA's members.3 As an ACH operator, the Reserve Banks, through Operating Circular 4, incorporate NACHA's Operating Rules and Guidelines as rules that govern clearing and settlement of commercial ACH items by the Reserve Banks, except for those provisions specifically excluded in the Operating Circular.4 The Reserve Banks' Operating Circular 4 does not govern ACH transactions conducted through EPN.

The Reserve Banks' current FedACH SameDay Service is an optional service that allows ODFI participants to originate same-day payments to all RDFI participants that agree to accept such payments.5 The Reserve Banks began offering the service in 2010 to address growing market demand for intraday ACH processing and settlement. In the five years since its introduction, the FedACH SameDay Service has experienced limited adoption; 78 depository institutions (less than 1 percent of FedACH customers) are currently using the service. A number of factors may account for this low adoption rate. RDFIs typically need to upgrade internal processing capabilities to post same-day transactions. Although ODFIs may be able to realize value from the service through enhanced ACH product offerings, such as emergency bill pay, these services may be unappealing to originators because of low RDFI participation and corresponding limited receiver reach. The current FedACH SameDay Service does not have an interbank fee.

Two aspects of NACHA's amended operating rules differ materially from the Reserve Banks' current FedACH SameDay Service. First, under NACHA's amended operating rules, receipt of same-day ACH transactions is mandatory and RDFIs must make funds available from same-day ACH credits to their depositors by 5:00 p.m.6 Second, NACHA's amended operating rules establish an interbank fee, paid by ODFIs to RDFIs for each forward same-day transaction.7 As described in greater detail below, NACHA designed the interbank fee, initially 5.2 cents per forward transaction, to allow RDFIs to offset costs associated with the up-front investments and ongoing operating costs necessary for accepting, posting, and making funds available from same-day transactions. The amended operating rules provide that the interbank fee will be reduced if actual same-day transaction volume exceeds original projections by more than 25 percent during regularly required review periods.8 Ten years after the final phase of implementation is effective, and every ten years thereafter, NACHA will reevaluate the interbank fee.9 Under NACHA's amended operating rules the interbank fee may not be increased from its initial level of 5.2 cents per forward transaction.

These differences require enhancements to the Reserve Banks' existing FedACH SameDay Service that may have a significant longer-run effect on the nation's payment system.10 Therefore, the Board requested comment on the following:

• Making receipt of same-day ACH transactions mandatory for all RDFIs. If commenters believed that participation by RDFIs should not be mandatory, the Board requested comment on why the Reserve Banks' same-day ACH service should remain optional and whether there are non-mandatory alternatives to achieving ubiquity.

• Whether the interbank fee included in NACHA's amended operating rules equitably reapportions the initial implementation costs and ongoing operating costs between ODFIs and RDFIs.

The Board received forty comments in response to its request. Comments were submitted by depository institutions, depository institution trade associations, national and regional payments associations, associations representing end users (consumers and businesses) and third-party payment processors, a private-sector ACH operator, and an individual. Twenty-two commenters stated that receipt of same-day ACH transactions should be mandatory and that the interbank fee appropriately reapportions costs between ODFIs and RDFIs. Three commenters generally supported same-day ACH services but did not specifically address mandatory receipt or the equity of the interbank fee. Fifteen commenters expressed some concern with one or both of the topics on which the Board requested comment.

Thirty-seven commenters addressed mandatory receipt of same-day ACH transactions. Twenty-nine commenters believed that mandatory receipt is critical to the success of a same-day ACH service. These commenters, including seven small depository institutions or associations representing such institutions, generally agreed that mandating receipt is necessary to achieve a ubiquitous same-day ACH service that provides value to end users and depository institutions and achieves the associated public benefits that come from the enhanced efficiency of the ACH network. Making receipt of same-day transactions optional, they argue, would severely limit the benefits of any same-day ACH service. One commenter (one letter representing two merchant associations), which agreed that mandatory receipt is necessary to achieve a ubiquitous same-day ACH service, requested that the Board abandon same-day ACH services to develop real-time ACH processing.

Eight commenters, all credit unions or credit union associations, expressed concern that mandatory receipt of same-day ACH transactions would be overly burdensome on smaller depository institutions. These commenters indicated that technical and operational changes are necessary to receive same-day ACH transactions, and that small institutions will be disproportionately affected because they would be unable to adequately offset the associated costs of receiving such transactions because of their lower same-day ACH volume. Only three of these commenters suggested alternatives: Two commenters suggested that the Board exempt smaller depository institutions from any mandatory receipt requirements, and one commenter suggested limiting same-day ACH transactions to a single morning submission and afternoon settlement deadline to reduce the burden on smaller depository institutions.11 The commenters that supported making receipt mandatory included seven small depository institutions or associations representing such institutions, including a community-bank trade group. These commenters supported mandatory receipt even in light of the associated costs.

The Board believes that the benefits of same-day ACH service outweigh the costs institutions would incur to implement such a service. Same-day ACH capability will facilitate the use of the ACH network for certain time-critical payments, accelerate final settlement, and improve funds availability to payment recipients.12 The Board believes that these capabilities will in turn provide a more efficient electronic payment option for person-to-person payments, expedited bill payments, same-day payroll payments, and other types of transactions.13 In light of the widespread industry support for a same-day ACH service with an interbank fee, as evidenced by the approval of the NACHA amended operating rules, the Board believes that the costs incurred to implement such a service are outweighed by the enhanced efficiency of the ACH network and the broader U.S. payment system.

The Board also believes that ubiquity is necessary to achieve these benefits. As with existing next-day ACH services, same-day ACH will be most efficient if originators can be certain that same-day ACH transactions will reach any banked receiver. If the same-day ACH service lacks this ubiquity, originators would be able to use the service to reach only a subset of their intended receivers, substantially reducing the attractiveness of the service. The Board believes, and commenters supporting mandatory receipt agreed, that the limited adoption of the Reserve Banks' current FedACH SameDay Service demonstrates an optional service cannot achieve the ubiquity necessary to establish a successful same-day ACH service. The Board agrees with the majority of commenters that mandating receipt of same-day ACH transactions is the only practical method to achieve that necessary ubiquity and the corresponding benefits. Moreover, the interbank fee, discussed below, is designed to address the concerns of RDFIs about same-day ACH implementation and operating costs.

Although the Board acknowledges the concerns raised by some commenters regarding the burden of mandatory receipt of same-day ACH transactions for small depository institutions, the Board does not believe that any of the commenters provided a viable alternative for achieving ubiquity without such burdens. The Board believes that exempting small institutions would undermine the ubiquity—and therefore the utility—of the service. Finally, the Board believes that limiting same-day ACH transactions to a single morning submission and afternoon settlement deadline would reduce the utility of a same-day ACH service, particularly for West Coast depository institutions.

The Board believes that a ubiquitous same-day ACH service will offer considerable pro-competitive benefits. Ubiquitous same-day ACH service could create a new mechanism to compete with payment methods other than ACH, and may do so at a lower cost. As stated above, for example, same-day ACH capability will facilitate the use of the ACH network for certain time-critical payments, accelerate final settlement, and improve funds availability to payment recipients. The Board believes that these capabilities will in turn provide a more efficient electronic payment option for person-to-person payments, expedited bill payments, same-day payroll payments, and other types of transactions.

The Board also does not believe that same-day ACH capabilities should be abandoned to pursue real-time ACH payments as suggested by the merchant associations' letter, but rather believes that both services would be complementary. As outlined in the Federal Reserve's Strategies for Improving the U.S. Payment System paper (Strategies Paper), the Federal Reserve recently convened two task forces—faster payments and secure payments—where private-sector participants can collaborate to create approaches that will serve the public.14 The faster payments task force, with input from the secure payments task force, will identify and evaluate alternative approaches for implementing safe, ubiquitous, faster payments capabilities in the United States. The Board believes that these efforts are the most appropriate channels to further consider real-time ACH capabilities.

For these reasons, the Board has approved enhancements to the Reserve Banks' existing FedACH SameDay Service that make receipt of forward same-day ACH transactions mandatory for all RDFIs.

Thirty-four commenters addressed whether the interbank fee included in NACHA's amended operating rules equitably reapportions the initial implementation costs and ongoing operating costs between ODFIs and RDFIs.15 Thirty-two commenters supported an interbank fee as an appropriate method for allocating costs between parties.

Twenty-one commenters argued that an interbank fee of 5.2 cents is appropriate.16 These commenters generally stated that the interbank fee is necessary for achieving a ubiquitous same-day ACH service; without an interbank fee these commenters concluded that many RDFIs would have opposed NACHA's amended operating rules. Several commenters cited the failure of NACHA's Expedited Processing and Settlement (EPS) proposal in 2011 as evidence that a same-day ACH service lacking an interbank fee could not succeed.17

Ten commenters (nine credit unions or credit union associations and one bank holding company) supported an interbank fee but argued that the 5.2 cent fee is too low to allow smaller RDFIs to recover costs in a reasonable amount of time, particularly small RDFIs with limited same-day ACH volume. Two of these commenters suggested that the Board create a tiered fee structure instead of a flat fee, allowing smaller RDFIs to receive higher fees.

Two commenters (a large bank and one letter representing two merchant associations) opposed an interbank fee of any amount. The large bank commenter argued that any interbank fee will disproportionately compensate the largest RDFIs, resulting in unintended negative effects such as higher end-user fees. The merchant associations expressed concerns that the interbank fee will impair competition and may have antitrust implications. The large bank commenter requested that the Board proceed with a mandatory same-day ACH service without any interbank fee. The merchant associations believed that the Board lacks authority to require the Reserve Banks to collect and transfer an interbank fee. Several commenters expressed other concerns with the interbank fee: That NACHA would increase the interbank fee in the future, and that ODFIs would pass the interbank fee on to their customers using the service.

After considering the comments received, and given the rejection of NACHA's 2011 EPS proposal, the Board has concluded that in this specific instance an interbank fee is necessary to achieve a ubiquitous same-day ACH service.18 Many commenters argued that the inclusion of an interbank fee increased RDFIs' willingness to approve NACHA's amended operating rules because without an interbank fee, RDFIs would have lacked the needed business justification to approve the mandatory receipt requirement that is critical to achieving ubiquity. In addition, as noted above, the Federal Reserve's current same-day ACH service, which is not mandatory and does not include an interbank fee, is not widely used. The Board considered whether a ubiquitous same-day ACH service could be achieved by mandating in the Reserve Banks' Operating Circular 4 that FedACH customers receive same-day ACH transactions without providing for an interbank fee. The Board does not believe that this is a viable alternative. As described above, the Reserve Banks' Operating Circular 4 applies only to FedACH customers and does not govern ACH transactions conducted through the other ACH operator, EPN. Therefore, any mandate adopted by the Reserve Banks would apply only to FedACH customers and not to EPN customers, resulting in a same-day service that is not ubiquitous.19 The Board also believes that the interbank fee must be implemented by the Reserve Banks as ACH operator, as it would be infeasible for thousands of depository institutions to collect interbank fees bilaterally. The Board has authority to require the Reserve Banks to collect and transfer this fee under the Federal Reserve Act.20

In order to calculate a per-transaction interbank fee that would allow RDFIs in the aggregate to recover implementation and ongoing operational costs associated with the receipt of same-day ACH transactions, the Board believes that an appropriate methodology requires certain inputs: A projection of one-time implementation costs associated with same-day ACH receipt, a projection of ongoing costs associated with same-day ACH receipt, and projections of future same-day ACH volume. The process would include obtaining data from participants in the ACH system, estimating the relationship between costs and transaction volume, extrapolating those estimates to the broader universe of ACH participants, and projecting future costs and transaction volume.

NACHA commissioned a consultant to calculate the interbank fee. The Board has reviewed the consultant's methodology, which contained the inputs discussed above. The Board also reviewed the consultant's assumptions and judgments necessary to construct these inputs and use them to construct the fee. The Board believes the data and analysis provide a reasonable basis for the interbank fee, given the fact that NACHA had to collect data from voluntary respondents, make various projections into the future, and deal with significant non-response.21

To facilitate its projections, the consultant surveyed a sample of RDFIs to obtain those banks' projected implementation and ongoing operational costs. The consultant also interviewed banks and third-party processors to understand the potential uses of same-day ACH. Based on interviews, the consultant determined that the largest RDFIs typically use internal systems to process ACH transactions, while other RDFIs typically outsource to third-party processors. Accordingly, the consultant asked only large RDFIs and third-party processors about one-time implementation costs. All surveyed RDFIs were asked about ongoing operational costs under three different same-day volume scenarios. Fourteen large RDFIs and 175 smaller RDFIs responded to the survey, yielding a sample with reasonable representation across RDFI sizes. The Board reviewed the survey instruments and cost data aggregated in seven groups according to RDFI size; NACHA did not make cost data of individual survey respondents available, citing confidentiality provisions under which the data were provided by RDFIs. The Board believes the survey instrument was reasonably designed to obtain the necessary data.

Using data from these RDFIs, the consultant estimated relationships between costs and volumes, and used these relationships to extrapolate to non-responding RDFIs. Projections of same-day ACH volume were based upon information from ODFIs, NACHA, and other subject matter experts. Projected adoption rates for ten broad use cases formed the basis for the projections of total same-day ACH volume. Given its projections of costs and volumes, the consultant chose a fee that, by its calculation, sets the present discounted value of aggregate projected RDFI interbank fee revenues equal to the present discounted value of aggregate projected RDFI costs for all RDFIs as a whole.22

The Board recognizes that projections of future costs and volumes are inherently subjective, but believes the approach used to determine the interbank fee is reasonable. Specifically, interviews with industry participants and extensive review of potential use cases provided a reasonable basis for estimating future demand for a product that has not yet been introduced. Also, the collection of data from a sample of RDFIs of varying sizes through a survey was a sensible way to assess potential costs of the service. The Board not only reviewed the methodology used to calculate the fee, but also considered the implications of the fee for the ACH industry. The Board found the fee to be reasonable once NACHA addressed issues with respect to opportunity costs in the fee and the potential for the fee to rise over time, as described below.

NACHA issued its same-day ACH rule for public comment in December 2014. At that time, NACHA proposed an interbank fee of 8.2 cents. The calculation of that fee included opportunity costs resulting from the movement of transactions from higher-margin payments methods, such as wire, to same-day ACH, essentially transferring to same-day ACH the high margins that result from banks having market power in other services. In its final rule, NACHA removed the opportunity cost component of the fee, thereby lowering the fee from 8.2 to 5.2 cents.

The Board believes that the lower interbank fee of 5.2 cents reasonably balances depository institutions' ability to offset costs with the needs of ACH end users. As discussed above, a 5.2 cent interbank fee would allow cost recovery for RDFIs as a whole. Although the fee may not allow full cost recovery for all RDFIs, it will allow all RDFIs to offset a portion of their costs. The Board expects that, in most cases, the interbank fee will ultimately be borne by end users that originate same-day ACH transactions, a concern echoed by several commenters. For some originators, faster settlement or funds availability associated with same-day ACH may be worth these potentially higher costs, and their same-day ACH costs (even with the pass-through of the interbank fee) may still be substantially lower than the costs they would incur using other payment methods, such as wire transfers. Originators that wish to avoid such potential costs can continue to use existing lower-cost next-day ACH options and the Federal Reserve has no plans to eliminate its next-day ACH settlement. The Board believes that a higher interbank fee would likely result in higher costs being passed to originators and may reduce demand for same-day ACH services, resulting in a ubiquitous but lesser-used service.23

The Board has not adopted the suggestion to tier the fee to allow smaller institutions to recover more than the 5.2 cent fee because it does not believe there is a clear correlation between institution size and implementation costs. As described above, smaller RDFIs often outsource their ACH and transaction account processing, and may not incur costs as material as those RDFIs that do not outsource this processing.

The Board does not believe that the interbank fee will rise over time, as has been the experience in the card industry. To address this concern, NACHA proposed provisions that provided for the potential reduction in the fee, and adopted a rule to ensure that the fee could not be increased in the future. The Board recognizes that NACHA members could vote to amend NACHA's operating rules to allow the interbank fee to increase above 5.2 cents, but no such increase would apply to FedACH same-day volume unless the Board and the Reserve Banks (as ACH operator) agree to such an increase.

NACHA's amended operating rules also include a 5-year review and 8-year review of the fee. At each of these reviews, if the volume of same-day transactions exceeds the NACHA projection by more than 25 percent, the fee will be lowered to a level pre-calculated by NACHA and intended to allow RDFIs achieve cost recovery on an aggregate basis. A schedule of possible fee decreases is available on the Board's Web site.24 If the fee is lowered as a result of such reviews, the lower fee amount establishes a new ceiling, above which the interbank fee cannot rise. The Board believes that the lower interbank fee of 5.2 cents, combined with regularly scheduled reviews to determine any necessary reduction in the fee in pre-calculated intervals, allow cost recovery for RDFIs over time while maintaining the attractiveness of the same-day service to ODFIs and originators.

Based on its review of these comments, the Board has approved enhancements to the Reserve Banks' existing FedACH SameDay Service to include an interbank fee paid by ODFIs to RDFIs not to exceed 5.2 cents for each forward same-day transaction and to decrease that fee according to the fee schedules published on the Board's public Web site in the event that same-day ACH volume exceeds projections by more than 25 percent during one of the regularly scheduled review periods. Any other changes to the interbank fee will require additional consideration and action by the Board.

The Board received comments on several other topics related to enhancements to the Reserve Banks' existing FedACH SameDay Service.

Several commenters raised questions about the processing and settlement windows for same-day ACH transactions. As noted above, one commenter asked the Board to consider a single morning submission and afternoon settlement deadline, while another commenter argued that institutions outside the Eastern Time Zone will only gain limited benefits from same-day ACH. A third commenter requested that the Board consider extending its National Settlement Service deadline to be inclusive of business hours in all U.S. time zones.

The Reserve Banks are reviewing the same-day ACH processing windows and will work with NACHA and EPN to establish processing schedules that are convenient for as many institutions as possible across the network. The Board has also previously expressed its intent to enhance the National Settlement Service and will review extended deadlines and potential enhancements as described in the Strategies Paper.25

Several commenters noted an increased potential for fraud with same-day ACH transactions related to shorter processing windows. The Board recognizes that same-day ACH transactions may have a different risk profile than existing next-day ACH transactions. The Reserve Banks have in place alert services that can assist RDFIs in monitoring risk profiles specific to same-day ACH transactions, and the Board is aware that NACHA and the regional payment associations have already started reviewing risk management issues related to same-day ACH transactions. The Board believes that any risks related to same-day ACH can be appropriately mitigated by the industry in collaboration with NACHA and the ACH operators.

Several commenters expressed concerns that the availability of same-day ACH services would lead to the discontinuation or unnecessary migration away from low-cost next-day ACH services. The Board believes that next-day ACH services will remain relevant in light of likely continued demand by end users for low cost and efficient options for payments that do not require same-day settlement or processing, such as regularly scheduled payroll files or bill payments. Retaining next-day ACH service also reduces operational risk by allowing ODFIs and operators an opportunity to recover from disruptions without delaying the settlement of transactions.

The Federal Reserve has no plans to discontinue next-day services, but it cannot ensure that any given depository institution would continue to offer next-day ACH origination services to its customers. In a competitive marketplace for deposit and payment services, however, if a depository institution were to stop offering next-day ACH origination to its customers, the demand for that service would likely be met by other depository institutions.

The Board does not believe that ODFIs will cease offering next-day ACH origination in an effort to drive volume to same-day ACH transactions, thus increasing RDFI interbank fee revenue. If that were to happen, same-day ACH volume would far exceed the volume expectations used in calculating the 5.2 cent interbank fee, which would result in a reduction of the fee following the regularly scheduled reviews. The Board intends to monitor the adoption of same-day ACH and the continued availability of next-day ACH services. The Board will reevaluate the amount and appropriateness of any interbank fee if low-cost next-day ACH origination services are widely replaced by same-day ACH services, increasing costs to originators.

In considering new services and major service enhancements to existing Reserve Bank services, the Board requires the following criteria be met: the service must enable full long-run recovery of costs by the Reserve Banks; the service must yield a clear public benefit; and the service must be one that other providers alone cannot be expected to provide with reasonable effectiveness, scope, and equity.26

The Board believes that the introduction of a FedACH same-day service with mandatory participation by RDFIs and an interbank fee meets these criteria.27 The service will not adversely affect the Reserve Banks' ability to recover the cost of providing the ACH service over the long run as operating costs can be recovered through fees charged for using the Reserve Banks' ACH services.28

The service also offers clear public benefits. Same-day ACH capability will facilitate the use of the ACH network for certain time-critical payments, accelerate final settlement, and improve funds availability to payment recipients. The Board believes that a ubiquitous same-day ACH service would enhance the efficiency of the ACH network and the broader U.S. payment system by providing a more efficient electronic payment option for person-to-person payments, expedited bill payments, same-day payroll payments, and other types of transactions. As several commenters noted, this is consistent with the strategic goals identified in the Strategies Paper.29

The Board also believes that the private sector cannot be expected to provide the service alone with reasonable effectiveness, scope, or equity. Without incorporation of NACHA's amended operating rules by the Reserve Banks, a viable same-day ACH service would be unlikely.30 Without the ability to reach any RDFI in the ACH network, the Board believes that any same-day ACH service would be ineffective and any corresponding public benefits would be limited.

When considering changes to an existing service, the Board also conducts a competitive impact analysis to determine whether there will be a direct and material adverse effect on the ability of other service providers to compete effectively with the Federal Reserve in providing similar services due to differing legal powers or the Federal Reserve's dominant market position deriving from such legal differences.31 The Board believes that there are no adverse effects to other service providers resulting from adoption of the amended operating rules. The changes to the Reserve Banks' existing service conform the service to industry-wide ACH operating rules that can be adopted by both ACH operators.32 The changes are not the result of any differing legal powers or any dominant market position resulting from legal differences.

Based on its review of comments received, the Board has approved enhancements to the Reserve Banks' FedACH SameDay Service that require RDFIs to participate in the service and ODFIs to pay a fee to RDFIs for each same-day ACH forward transaction. The enhancements will be adopted by incorporation of NACHA's amended operating rules into Operating Circular 4, governing the Reserve Banks' ACH services.

A. Purpose

The North Carolina Sales and Use Tax Act authorizes counties and incorporated cities and towns to obtain each year, from the Commissioner of Revenue of the State of North Carolina, a refund of sales and use taxes indirectly paid on building materials, supplies, fixtures, and equipment that become a part of or are annexed to any building or structure in North Carolina.

However, to substantiate a refund claim for sales or use taxes paid on purchases of building materials, supplies, fixtures, or equipment by a contractor, the Government must secure from the contractor certified statements setting forth the cost of the property purchased from each vendor and the amount of sales or use taxes paid. Similar certified statements by subcontractors must be obtained by the general contractor and furnished to the Government. The information is used as evidence to establish exemption from State and local taxes.

Respondents: 314.

Responses per Respondent: 1.

Annual Responses: 314.

Hours per Response: 1.25.

Total Burden Hours: 392.

Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of functions of the Federal Acquisition Regulations (FAR), and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.

Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405, telephone 202-501-4755. Please cite OMB Control No. 9000-0059, North Carolina Sales Tax Certification, in all correspondence.

Per FAR 52.215-1(c)(2)(iv), firms offering supplies or services to the Government under negotiated solicitations must provide the names, titles, and telephone numbers of authorized negotiators to assure that discussions are held with authorized individuals. The information collected is referred to before contract negotiations and it becomes part of the official contract file.

Respondents: 68,000.

Responses per Respondent: 8.

Total Responses: 544,000.

Hours per Response: .017.

Total Burden Hours: 9248.

Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of functions of the Federal Acquisition Regulations (FAR), and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.

Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat (MVCB), 1275 First Street NE., Washington, DC 20417, telephone 202-501-4755. Please cite OMB Control No. 9000-0048, Authorized Negotiator, in all correspondence.

Government contractors that use company aircraft must maintain logs of flights containing specified information (e.g., destination, passenger name, purpose of trip, etc.). This information, as required by FAR 31.205-46, Travel Costs, is used to ensure that costs of owned, leased or chartered aircraft are properly charged against Government contracts and that directly associated costs of unallowable activities are not charged to such contracts.

Number of Respondents: 3,000.

Responses per Respondent: 1.

Total Responses: 3,000.

Average Burden per Response: 6.

Total Burden Hours: 18,000.

Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of functions of the Federal Acquisition Regulation (FAR), and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.

Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405, telephone 202-501-4755. Please cite OMB Control No. 9000-0079, Corporate Aircraft Costs, in all correspondence.

FAR 22.1103 requires that all professional employees are compensated fairly and properly. Accordingly, FAR 52.222-46, Evaluation of Compensation for Professional Employees, is required to be inserted in solicitations for negotiated service contracts when the contract amount is expected to exceed $650,000 and the service to be provided will require meaningful numbers of professional employees. The purpose of the provision at FAR 52.222-46 is to require offerors to submit for evaluation a total compensation plan setting forth proposed salaries and fringe benefits for professional employees working on the contract. Plans indicating unrealistically low professional employees' compensation may be assessed adversely as one of the factors considered in making a contract award.

Respondents: 12,921.

Responses per Respondent: 3.

Total Responses: 38,763.

Hours per Response: 1.333333.

Total Burden Hours: 51,684.

Public comments are particularly invited on: Whether this collection of information is necessary; whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.

Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405, telephone 202-501-4755.

Please cite OMB Control No. 9000-0066, Professional Employee Compensation Plan, in all correspondence.

The clause at FAR 52.215-14, Integrity of Unit Prices, requires offerors and contractors under Federal contracts that are to be awarded without adequate price competition to identify in their proposals those supplies which they will not manufacture or to which they will not contribute significant value. The policies included in the FAR are required by 41 U.S.C. 3503 (a)(1)(A)(for the civilian agencies) and 10.U.S.C 2306a(b)(1)(A)(i)(for DOD and NASA). The rule contains no reporting requirements on contracts below the simplified acquisition threshold, construction and architect-engineering services, utility services, service contracts where supplies are not required, commercial items, and contracts for petroleum products.

Respondents: 950.

Responses per Respondent: 10.

Annual Responses: 9,500.

Hours per Response: 1.

Total Burden Hours: 9,500.

Public comments are particularly invited on: Whether this collection of information is necessary; whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.

Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405, telephone 202501-4755. Please cite OMB Control No. 9000-0080, Integrity of Unit Prices.

The loss of ovarian function with menopause leads to a drastic reduction in circulating estrogen concentration, which in turn leads to physiologic changes to the vulva, vagina, and lower urinary tract. Reduced circulating estrogen concentration results in an increase in vaginal pH, a thinning and reduction of the folds of the vaginal lining, reduction of vaginal secretions, and loss of elasticity in vaginal tissues. Symptoms of decreased circulating estrogen include vaginal and vulvar itching and/or irritation, vaginal dryness and vaginal pain (dyspareunia), and/or bleeding with intercourse. Not all postmenopausal women have symptoms of VVA that require treatment, but some women (particularly those 5 to10 years postmenopausal), when asked, will report one or more of the above symptoms, which they deem to be bothersome and self-categorize as moderate to severe in intensity. To date, the Agency has approved estrogen products (both estrogen-alone and estrogen plus progestin) for the indications of “treatment of moderate to severe vaginal dryness, a symptom of vulvar and vaginal atrophy due to menopause” and “treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause.”

Estrogen-alone products have Boxed Warnings stating:

(1) There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogen;

(2) estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia;

(3) an increased risk of stroke and deep vein thrombosis was reported in the Women's Health Initiative (WHI) estrogen-alone substudy; and

(4) an increased risk of probable dementia in postmenopausal women 65 years of age and older was reported in WHI Memory Study (WHIMS) estrogen-alone ancillary study.

The WHI estrogen-alone studies evaluated only a single estrogen dose consisting of 0.625 mg of conjugated estrogen. As lower-dose estrogen products are now approved for the treatment of moderate to severe symptoms of VVA due to menopause, some in the scientific/medical community have questioned whether these statements in the Boxed Warning section are applicable in whole or in part to the lower-dose estrogen products.

The scientific workshop on November 10th will include discussions of scientific challenges related to the following topics:

• The relevance to lower-dose estrogen products of the Boxed Warnings related to the WHI findings that: (1) Estrogens should not be used for the prevention of cardiovascular disease or dementia, (2) there is an increased risk of stroke and deep vein thrombosis in women treated with estrogen-alone, and (3) there is an increased risk of probable dementia in postmenopausal women 65 years of age and older treated with estrogen-alone.

• How to educate prescribers on the interpretation of estrogen exposure data across various estrogen dosage forms indicated for treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. Presentation of basic PK and clinical pharmacology data concepts and an informed framework for comparing various estrogen products for prescribing purposes.

• Discuss the level of available data supporting that a given estrogen serum concentration is or is not related to adverse outcomes (for example, pulmonary emboli, deep venous thrombosis, and myocardial infarction).

• Presentation and discussion of PD biomarkers for thrombosis. Presentation of a comparison of metabolic profiles from various products, key clotting factors responsible for thrombosis, and PK/PD relationships.

If you wish to attend this meeting, email [email protected]. Please register by October 16, 2015. Those who are unable to attend the meeting in person can register to view a live Webcast of the meeting. You will be asked to indicate in your registration whether you plan to attend in person or via the Webcast. Your registration should also contain your complete contact information, including name, title, affiliation, address, email address, and telephone number.

Seating will be limited, so early registration is recommended. Registration is free and will be on a first-come, first-served basis. However, FDA may limit the number of participants from each organization based on space limitations. Registrants will receive confirmation once they have been accepted. Onsite registration on the day of the meeting will be based on space availability. If you need special accommodations because of disability, please contact Kimberly Shiley (see FOR FURTHER INFORMATION CONTACT) at least 7 days before the meeting.

FDA will hold an open public comment session during the November 10th public meeting to give the public an opportunity to comment. Register for this session at [email protected] by October 16, 2015. Additional registration will occur at the registration desk on the day of the meeting on a first-come, first-served basis if there is still time available during this session.

Docket Comments: Regardless of attendance at the meeting, you can submit electronic or written comments, including responses to the public docket (see ADDRESSES), by October 16, 2015. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

Transcripts: Transcripts for the November 10th meeting will be posted, when available, at http://www.fda.gov/Drugs/NewsEvents/ucm401167.htm.

I. Introduction

On July 9, 2012, the Food and Drug Administration Safety and Innovation Act, which included BsUFA (Pub. L. 112-144, title IV), was signed into law by the President. BsUFA authorizes FDA to collect fees for certain activities relating to biosimilar biological product development, for certain types of applications and supplements for approval of biosimilar biological products, on establishments where approved biosimilar biological products are made, and on biosimilar biological products after approval.

BsUFA's intent is to provide additional revenues so that FDA can hire more staff, improve systems, and establish a better managed biosimilar biological product review process to make biosimilar biological product therapies available to patients sooner without compromising review quality. As part of FDA's agreement with industry during the first BsUFA authorization, the Agency agreed to certain performance goals. These goals, which are captured in a Commitment Letter, apply to the process for the review of biosimilar biological product applications, including biosimilar biological product development meetings, review of applications and supplements, and other review activities.

Although BsUFA is similar to the Prescription Drug User Fee Act (PDUFA) program in that it includes fees for marketing applications, manufacturing establishments, and products, there are some differences because of the relatively nascent state of the biosimilar industry in the United States. For example, at the time BsUFA was signed into law, there were no currently marketed biosimilar biological products. Accordingly, BsUFA includes fees for products in the development phase in order to generate fee revenue to support FDA's review work during this phase and enable sponsors to have meetings with FDA early in the development of biosimilar biological product candidates. Additional information concerning BsUFA, including the text of the law, the “Biosimilar Biological Product Authorization Performance Goals And Procedures—Fiscal Years 2013 Through 2017” (the Commitment Letter), key Federal Register documents, BsUFA-related guidances, performance reports, and financial reports may be found on the FDA Web site at http://www.fda.gov/forindustry/userfees/biosimilaruserfeeactbsufa/default.htm.

FDA is announcing a public meeting on BsUFA. The authority for BsUFA expires at the end of September 2017. Without new legislation, FDA will no longer be able to collect user fees to fund the biosimilar biological product review process. Before FDA begins negotiations with the regulated industry on BsUFA reauthorization, the Agency is holding the public meeting announced in this notice, at which members of the public may present their views on reauthorization, including any suggestions for changes to the performance goals referred to in the Commitment Letter. In addition, FDA will provide a period of 30 days after the public meeting to obtain written comments from the public. The purpose of this public meeting is to hear stakeholder views as we consider whether to retain, change, or discontinue the current BsUFA performance goals in the next BsUFA. In addition to any other relevant information the public would like to share, the FDA is interested in responses to the following two general questions:

• What is your assessment of the overall performance of the BsUFA program to date?

• What aspects of BsUFA performance goals should be retained, changed, or discontinued to further strengthen and improve the program?

The meeting will likely include presentations by FDA and a series of panels representing different stakeholder groups. We will also provide an opportunity for other stakeholders to provide public comment at the meeting. FDA policy issues are beyond the scope of these reauthorization discussions. Accordingly, the comments should focus on process enhancements and funding issues, and not on policy issues.

If you wish to attend this meeting, visit https://fdapublicmeeting-bsufa.eventbrite.com. Please register by November 18, 2015. If you are unable to attend the meeting in person, you can register to view a live Webcast of the meeting. You will be asked to indicate in your registration if you plan to attend in person or via the Webcast. Your registration must also contain your complete contact information, including name, title, affiliation, address, email address, and phone number. Seating will be limited, so early registration is recommended. Registration is free and will be on a first-come, first-served basis. However, FDA may limit the number of participants from each organization based on space limitations. Registrants will receive confirmation once their registrations have been accepted. Onsite registration on the day of the meeting will be based on space availability. If you need special accommodations because of a disability, please contact Sandra Benton (see FOR FURTHER INFORMATION CONTACT) at least 7 days before the meeting.

In addition, any person may submit written or electronic comments to the Division of Dockets Management (see ADDRESSES). Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. To ensure consideration, all comments must be received by January 19, 2016.

Please be advised that as soon as a transcript is available, it will be accessible at http://www.fda.gov/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/UCM461774.htm.

In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies.

ICH was organized to provide an opportunity for tripartite harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products among three regions: Europe, Japan, and North America. The eight ICH sponsors are the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; CDER and CBER, FDA; the Pharmaceutical Research and Manufacturers of America; Health Canada; and Swissmedic. The ICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation of Pharmaceutical Manufacturers Associations (IFPMA).

The ICH Steering Committee includes representatives from each of the ICH sponsors and the IFPMA, as well as observers from the World Health Organization.

In June 2015, the ICH Steering Committee agreed that the following draft guidance should be made available for public comment: “M7(R1) Addendum to ICH M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk; Application of the Principles of the ICH M7 Guidance to Calculation of Compound-Specific Acceptable Intakes.” The draft guidance is the product of the Expert Working Group of the ICH. Comments about this draft will be considered by FDA and the Expert Working Group.

The draft guidance provides guidance on acceptable intake limits derived for some chemicals that are considered to be mutagens and carcinogens and that were selected because they are commonly used in pharmaceutical manufacturing or are useful in illustrating the principles of deriving compound-specific intakes as described in ICH M7. The default method from ICH M7 of linear extrapolation from the cancer potency estimate, TD50, is used as the primary method to derive the acceptable intakes for carcinogens with likely mutagenic mode of action.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

Persons with access to the Internet may obtain the document at http://www.regulations.gov, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

Section 908 of FDASIA (Pub. L. 112-144) added section 529 to the FD&C Act (21 U.S.C. 360ff). In section 529 of the FD&C Act, Congress encouraged development of new human drugs and biological products for prevention and treatment of certain rare pediatric diseases by offering additional incentives for obtaining FDA approval of such products. Under section 529 of the FD&C Act, the sponsor of an eligible human drug application submitted 90 days or more after July 9, 2012, for a rare pediatric disease (as defined in section 529(a)(3)) shall receive a priority review voucher upon approval of the rare pediatric disease product application. The recipient of a rare pediatric disease priority review voucher may either use the voucher for a future human drug application submitted to FDA under section 505(b)(1) of the FD&C Act (21 U.S.C. 355(b)(1)) or section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)), or transfer (including by sale) the voucher to another party that may then use it for a human drug application submitted to FDA under section 505(b)(1) of the FD&C Act or section 351(a) of the Public Health Service Act. A priority review is a review conducted with a Prescription Drug User Fee Act (PDUFA) goal date of 6 months after the receipt or filing date, depending on the type of application. Information regarding PDUFA goals is available at http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf.

The applicant that uses a rare pediatric disease priority review voucher is entitled to a priority review of its eligible human drug application, but must pay FDA a rare pediatric disease priority review user fee in addition to any fee required by PDUFA for the application. Information regarding the rare pediatric disease priority review voucher program is available at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm375479.htm.

This notice establishes the rare pediatric disease priority review fee rate for FY 2016 at $2,727,000 and outlines FDA's procedures for payment of rare pediatric disease priority review user fees. This rate is effective on October 1, 2015, and will remain in effect through September 30, 2016.

Under section 529(c)(2) of the FD&C Act, the amount of the rare pediatric disease priority review user fee is determined each fiscal year based on the difference between the average cost incurred by FDA in the review of a human drug application subject to priority review in the previous fiscal year, and the average cost incurred by FDA in the review of a human drug application that is not subject to priority review in the previous fiscal year. The rare pediatric disease priority review voucher fee is intended to cover the incremental costs for FDA to do a priority review on a human drug application that would otherwise get a standard review. The formula provides the Agency with the added resources to conduct a priority review while still ensuring a robust rare pediatric disease priority review voucher program that is consistent with the Agency's public health goal of encouraging the development of new human drugs and biological products for rare pediatric diseases.

A priority review is a review conducted with a PDUFA goal date of 6 months after the receipt or filing date, depending on the type of application. Under the PDUFA goals letter, FDA has committed to reviewing and acting on 90 percent of the applications granted priority review status within this expedited timeframe. Normally, an application for a human drug or biological product will qualify for priority review if the product is intended to treat a serious condition and, if approved, would provide a significant improvement in safety or effectiveness. An application that does not receive a priority designation will receive a standard review. Under the PDUFA goals letter, FDA has committed to reviewing and acting on 90 percent of standard applications within 10 months of the receipt or filing date depending on the type of application. A priority review involves a more intensive level of effort and a higher level of resources than a standard review.

Section 529 of the FD&C Act specifies that the rare pediatric disease priority review voucher fee amount must be based on the difference between the average cost incurred by the Agency in the review of a human drug application subject to a priority review in the previous fiscal year, and the average cost incurred by the Agency in the review of a human drug application not subject to a priority review in the previous fiscal year. FDA is setting a fee for FY 2016, which is to be based on standard cost data from the previous fiscal year, FY 2015. However, the FY 2015 submission cohort has not been closed out yet, thus the cost data for FY 2015 are not complete. The latest year for which FDA has complete cost data is FY 2014. Furthermore, because FDA has never tracked the cost of reviewing applications that get priority review as a separate cost subset, FDA estimated this cost based on other data that the Agency has tracked. FDA uses data that the Agency estimates and publishes on its Web site each year—standard costs for review. FDA does not publish a standard cost for “the review of a human drug application subject to priority review in the previous fiscal year.” However, we expect all such applications would contain clinical data. The standard cost application categories with clinical data that FDA publishes each year are: (1) New drug applications (NDAs) for a new molecular entity (NME) with clinical data and (2) biologics license applications (BLAs) with clinical data.

The standard cost worksheets for FY 2014 show standard costs (rounded to the nearest thousand dollars) of $5,646,000 for an NME NDA, and $5,533,000 for a BLA. Based on these standard costs, the total cost to review the 48 applications in these two categories in FY 2014 (30 NME NDAs and 18 BLAs with clinical data) was $268,974,000. (Note: These numbers exclude the President's Emergency Plan for AIDS Relief NDAs; no investigational new drug (IND) review costs are included in this amount.) Twenty-nine of these applications (20 NDAs and 9 BLAs) received priority review, which would mean that the remaining 19 received standard reviews. Because a priority review compresses a review schedule that ordinarily takes 10 months into 6 months, FDA estimates that a multiplier of 1.67 (10 months divided by 6 months) should be applied to non-priority review costs in estimating the effort and cost of a priority review as compared to a standard review. This multiplier is consistent with published research on this subject which supports a priority review multiplier in the range of 1.48 to 2.35 (Ref. 1). The multiplier derived by FDA falls well below the midpoint of this range. Using FY 2014 figures, the costs of a priority and standard review are estimated using the following formula:

Where “α” is the cost of a standard review and “α times 1.67” is the cost of a priority review. Using this formula, the cost of a standard review for NME NDAs and BLAs is calculated to be $3,989,000 (rounded to the nearest thousand dollars) and the cost of a priority review for NME NDAs and BLAs is 1.67 times that amount, or $6,662,000 (rounded to the nearest thousand dollars). The difference between these two cost estimates, or $2,673,000, represents the incremental cost of conducting a priority review rather than a standard review.

For the FY 2016 fee, FDA will need to adjust the FY 2014 incremental cost by the average amount by which FDA's average costs increased in the 3 years prior to FY 2015, to adjust the FY 2014 amount for cost increases in FY 2015. That adjustment, published in the Federal Register on August 3, 2015 (see 80 FR 46028 at 46029), is 2.0266 percent for the most recent year, not compounded. Increasing the FY 2014 incremental priority review cost of $2,673,000 by 2.0266 percent results in an estimated cost of $2,727,000 (rounded to the nearest thousand dollars). This is the rare pediatric disease priority review user fee amount for FY 2016 that must be submitted with a priority review voucher for a human drug application in FY 2016, in addition to any PDUFA fee that is required for such an application.

The fee rate for FY 2016 is set out in table 1:

Under section 529(c)(4)(A) of the FD&C Act, the priority review user fee is due (i.e. the obligation to pay the fee is incurred) when a sponsor notifies FDA of its intent to use the voucher. Section 529(c)(4)(B) of the FD&C Act specifies that the application will be considered incomplete if the priority review user fee and all other applicable user fees are not paid in accordance with FDA payment procedures. In addition, section 529(c)(4)(C) specifies that FDA may not grant a waiver, exemption, reduction, or refund of any fees due and payable under this section of the FD&C Act. Beginning with FDA's appropriation for FY 2015, the annual appropriation language states specifically that priority review user fees authorized by 21 U.S.C. 360n and 360ff (section 529 of the FD&C Act) shall be credited to this account, to remain available until expended.” (Pub. L. 113-235, Section 5, Division A, Title VI).

The rare pediatric disease priority review fee established in the new fee schedule must be paid for any application that is received on or after October 1, 2015. In order to comply with this requirement, the sponsor must contact FDA before providing official notification of its intent to use the voucher.

FDA will issue an invoice to the sponsor who has incurred a rare pediatric disease priority review voucher fee when it receives the sponsor's notification of intent to use the voucher. The invoice will include instructions on how to pay the fee via wire transfer or check.

As noted in section II, if a sponsor uses a rare pediatric disease priority review voucher for a human drug application, the sponsor would incur the rare pediatric disease priority review voucher fee in addition to any PDUFA fee that is required for the application. The sponsor would need to follow FDA's normal procedures for timely payment of the PDUFA fee for the human drug application.

The following reference has been placed on display in the Division of Dockets Management (see ADDRESSES), and may be seen by interested person between 9 a.m. and 4 p.m., Monday through Friday.

FEMA proposes to make flood hazard determinations for each community listed in the table below, in accordance with Section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).

These proposed flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own, or pursuant to policies established by other Federal, State, or regional entities. These flood hazard determinations are used to meet the floodplain management requirements of the NFIP and are also used to calculate the appropriate flood insurance premium rates for new buildings built after the FIRM and FIS report become effective.

Use of a Scientific Resolution Panel (SRP) is available to communities in support of the appeal resolution process. SRPs are independent panels of experts in hydrology, hydraulics, and other pertinent sciences established to review conflicting scientific and technical data and provide recommendations for resolution. Use of the SRP may only be exercised after FEMA and local communities have been engaged in a collaborative consultation process for at least 60 days without a mutually acceptable resolution of an appeal. Additional information regarding the SRP process can be found online at http://floodsrp.org/pdfs/srp_fact_sheet.pdf .

The communities affected by the flood hazard determinations are provided in the table below. Any request for reconsideration of the revised flood hazard determinations shown on the Preliminary FIRM and FIS report that satisfies the data requirements outlined in 44 CFR 67.6(b) is considered an appeal. Comments unrelated to the flood hazard determinations will also be considered before the FIRM and FIS report are made final.

In the proposed flood hazard determination notice published at 80 FR 32396 in the June 8, 2015, issue of the Federal Register, FEMA published a table titled “Humboldt County, CA and Incorporated Areas”. This table contained inaccurate information as to the communities affected by the proposed flood hazard determinations featured in the table. The Cities of Eureka and Ferndale were not included in the previous notice.

In this document, FEMA is publishing a table containing the accurate information. The information provided below should be used in lieu of that previously published.

The specific flood hazard determinations are not described for each community in this notice. However, the online location and local community map repository address where the flood hazard determination information is available for inspection is provided.

Any request for reconsideration of flood hazard determinations must be submitted to the Chief Executive Officer of the community as listed in the table below.

The modifications are made pursuant to section 201 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq., and with 44 CFR part 65.

The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).

These flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. The flood hazard determinations are in accordance with 44 CFR 65.4.

The affected communities are listed in the following table. Flood hazard determination information for each community is available for inspection at both the online location and the respective community map repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at www.msc.fema.gov for comparison.