August 3, 2015 – Federal Register Recent Federal Regulation Documents

The National Ocean Council Committee on IUU Fishing and Seafood Fraud (NOC Committee) is seeking public input on draft principles for determining seafood species at risk of IUU fishing and seafood fraud (``at risk'') and a draft list of ``at risk'' species developed using the draft principles.

The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) [44 U.S.C. 3506(c)(2)(A)]. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Division of Longshore and Harbor Workers' Compensation is soliciting comments concerning the proposed collection: Carrier's Report of Issuance of Policy (LS-570). A copy of the proposed information collection request can be obtained by contacting the office listed below in the addresses section of this Notice.

The Caribbean Fishery Management Council (Council) will hold its 153rd meeting.

DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to implement a section of the National Defense Authorization Act for Fiscal Year 2013 that requires the issuance of guidance on the use of the authority to require the submission of other than cost or pricing data.

We (National Park Service) will ask the Office of Management and Budget (OMB) to approve the information collection (IC) described below. As required by the Paperwork Reduction Act of 1995 and as part of our continuing efforts to reduce paperwork and respondent burden, we invite the general public and other Federal agencies to take this opportunity to comment on this IC. We may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.

In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the National Cemetery Administration (NCA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.

The Veterans Health Administration (VHA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of a currently approved collection, and allow 60 days for public comment in response to the notice. This notice solicits comments on information needed to identify areas for improvement in clinical training programs.

The National Cemetery Administration (NCA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, and allow 60 days for public comment in response to the notice. This notice solicits comments on information that will increase public access to historic resources in national cemeteries. It will also increase public awareness of the legacy of the sacrifices of our nation's Veterans. NCA is developing a Historic Resources Education Program to serve academic and non-academic stakeholders.

The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed revision of a currently approved collection, and allow 60 days for public comment in response to the notice. This notice solicits comments on the information need to enroll claimants receiving benefit payments into an electronic funds transfer program.

The Veterans Health Administration (VHA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each revised collection, and allow 60 days for public comment in response to the notice. This notice solicits comments on the information needed for Veterans, Veteran Representatives and health care providers to request reimbursement from the federal government for emergency services at a private institution.

The Food and Drug Administration (FDA or Agency) is announcing a public meeting and an opportunity for public comment on Patient- Focused Drug Development for nontuberculous mycobacterial (NTM) lung infections. Patient-Focused Drug Development is part of FDA's performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patient perspectives on the impact of NTM lung infections on daily life and patient views on treatment approaches. FDA is also interested in discussing issues related to scientific challenges in developing drugs to treat NTM lung infections. In the afternoon, FDA will hold a workshop and provide information for and gain perspective from patients and patient advocacy organizations, health care providers, academic experts, and industry on various aspects of clinical development of drug products intended to treat NTM lung infections. The input from this public meeting will help in developing topics for further discussion.

The Federal Transit Administration (FTA) announces the availability of Section 5307 Urbanized Area Formula Grant program funds in support of the Discretionary Passenger Ferry Grant program. This grant opportunity will be funded using approximately $20 million in FY 2015 Urbanized Area Formula Grants program funds authorized by the Moving Ahead for Progress in the 21st Century Act (MAP-21), Public Law 112-141, July 6, 2012. Although MAP-21 authorized the program at $30 million, the current extension only authorized funds through May 31, 2015, which is approximately $20 million. This notice solicits proposals to compete for Fiscal Year (FY) 2015 funding that is currently available under the Ferry program and may include additional funds made available, subsequent to publication of this notice. The Passenger Ferry Grant program (Ferry program), authorized by 49 U.S.C. 5307 (h), is a competitive program for which FTA established criteria for rating and ranking applications. Given the limited resources available for this program, FTA is limiting this discretionary opportunity to capital projects. These funds constitute a core investment in the enhancement and revitalization of public ferry systems in the Nation's urbanized areas. This notice also includes priorities established by FTA for these discretionary funds, criteria FTA will use to identify meritorious projects for funding, and the process to apply for funding. This announcement is available on the FTA Web site at: https:// www.fta.dot.gov. The FTA may announce final selections on the Web site and in the Federal Register. Additionally, a synopsis of this funding opportunity will be posted in the FIND module of the government-wide electronic grants (GRANTS.GOV) Web site at https://www.grants.gov.

The Food and Drug Administration (FDA) is announcing the rates for abbreviated new drug applications (ANDAs), prior approval supplements to an approved ANDA (PASs), drug master files (DMFs), generic drug active pharmaceutical ingredient (API) facilities, and finished dosage form (FDF) facilities user fees related to the Generic Drug User Fee Program for fiscal year (FY) 2016. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Generic Drug User Fee Amendments of 2012 (GDUFA), authorizes FDA to assess and collect user fees for certain applications and supplements for human generic drug products, on applications in the backlog as of October 1, 2012 (only applicable to FY 2013), on FDF and API facilities, and on type II active pharmaceutical ingredient DMFs to be made available for reference. This document establishes the fee rates for FY 2016.

The Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2016 animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Animal Drug User Fee Amendments of 2013 (ADUFA III), authorizes FDA to collect user fees for certain animal drug applications and supplements, for certain animal drug products, for certain establishments where such products are made, and for certain sponsors of such animal drug applications and/or investigational animal drug submissions. This notice establishes the fee rates for FY 2016.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for fiscal year (FY) 2016 generic new animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Animal Generic Drug User Fee Amendments of 2013 (AGDUFA II), authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, for certain generic new animal drug products, and for certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. This notice establishes the fee rates for FY 2016.

The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2016. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device User Fee Amendments of 2012 (MDUFA III), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2016, which apply from October 1, 2015, through September 30, 2016. To avoid delay in the review of your application, you should pay the application fee before or at the time you submit your application to FDA. The fee you must pay is the fee that is in effect on the later of the date that your application is received by FDA or the date your fee payment is recognized by the U.S. Treasury. If you want to pay a reduced small business fee, you must qualify as a small business before making your submission to FDA; if you do not qualify as a small business before making your submission to FDA, you will have to pay the higher standard fee. Please note that the establishment registration fee is not eligible for a reduced small business fee. As a result, if the establishment registration fee is the only medical device user fee that you will pay in FY 2016, you should not submit a FY 2016 Small Business Qualification and Certification request. This document provides information on how the fees for FY 2016 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.

As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

The Commission is noticing a recent Postal Service filing concerning the addition of Priority Mail & First-Class Package Service Contract 7 negotiated service agreement to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed collections of information in accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A). This program helps to assure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Mine Safety and Health Administration (MSHA) is soliciting comments on the information collection for Explosive Materials and Blasting Units (pertains only to metal and nonmetal underground mines deemed to be gassy).

We, the National Marine Fisheries Service (NMFS), propose regulations to amend the Code of Federal Regulations (CFR) to implement the Endangered Species Act (ESA) regarding experimental populations. The CFR would be amended to establish definitions and procedures for: establishing and/or designating certain populations of species otherwise listed as endangered or threatened as experimental populations; determining whether experimental populations are ``essential'' or ``nonessential;'' and promulgating appropriate protective measures for experimental populations. We seek public comment on this proposal.

The Department of Labor (DOL) is submitting the Employment and Training Administration (ETA) sponsored information collection request (ICR) revision titled, ``Foreign Labor Certification Quarterly Activity Report,'' to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501 et seq.). Public comments on the ICR are invited.

The U.S. Nuclear Regulatory Commission (NRC) is considering issuance of amendments to Facility Operating License Nos. NPF-11 and NPF-18 issued to Exelon Generation Company, LLC (Exelon, the licensee) for operation of LaSalle County Station (LSCS), Units 1 and 2, located in LaSalle County, Illinois. The proposed amendment would revise the maximum allowable technical specification (TS) temperature of the ultimate heat sink for the plant. The NRC staff is issuing a final Environmental Assessment (EA) and Finding of No Significant Impact (FONSI) associated with the proposed license amendments.