June 1, 2016 – Federal Register Recent Federal Regulation Documents

The Advisory Committee was established by Public Law 98-181, November 30, 1983, to advise the Export-Import Bank on its programs and to provide comments for inclusion in the report on competitiveness of the Export-Import Bank of the United States to Congress. Time and Place: Wednesday, June 1, 2016 from 11:00 a.m.-3:00 p.m.. A break for lunch will be at the expense of the attendee. Security processing will be necessary for reentry into the building. The meeting will be held at EXIM Bank in the Main Conference Room11th Floor, 811 Vermont Avenue NW., Washington, DC 20571. Agenda: Discussion of EXIM's Annual Competitiveness Report to Congress. Public Participation: The meeting will be open to public participation, and 10 minutes will be set aside for oral questions or comments. Members of the public may also file written statement(s) before or after the meeting. If you plan to attend, a photo ID must be presented at the guard's desk as part of the clearance process into the building, you may contact Tia Pitt at tia.pitt@exim.gov to be placed on an attendee list. If any person wishes auxiliary aids (such as a sign language interpreter) or other special accommodations, please email Tia Pitt at tia.pitt@exim.gov prior to May 27, 2016. Members of the Press: For members of the Press planning to attend the meeting, a photo ID must be presented at the guard's desk as part of the clearance process into the building please email Tia Pitt at tia.pitt@exim.gov to be placed on an attendee list.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions.'' This guidance modifies FDA's current policy on categorization of IDE devices, which assists CMS in determining whether or not an IDE device should be covered (reimbursed) by CMS. On December 2, 2015, FDA's Center for Devices and Radiological Health (CDRH) and CMS's Coverage and Analysis Group (CAG) executed a Memorandum of Understanding (MOU) to streamline and facilitate the efficient categorization of investigational medical devices in order to support CMS's ability to make Medicare coverage (reimbursement) determinations for those investigational devices. The MOU noted the need for FDA and CMS to revise their shared understanding regarding categorization. This guidance document is intended to implement the MOU by further explaining the framework that FDA (both CDRH and the Center for Biologics Evaluation and Research) intends to follow for such decisions. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA) is announcing a public workshop entitled: OpenFDA Public Workshop. The purpose of the public workshop is to provide a forum for the openFDA system user community to engage in a robust interactive discussion and provide feedback to FDA regarding openFDA's platform, application programming interfaces (APIs), downloadable harmonized datasets, and possible enhancements to the openFDA platform, as well as to view the demonstration of various applications (apps) specifically developed for utilization of openFDA data.

The Export-Import Bank of the United States (EXIM Bank), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal Agencies to comment on the proposed information collection, as required by the Paperwork Reduction Act of 1995. EXIM Bank has an electronic disbursement approval processing system for guarantee lenders with transactions documented under Medium-Term Master Guarantee Agreements. After an export transaction has been authorized by EXIM Bank and legal documentation has been completed, the lender will obtain and review the required disbursement documents (e.g., invoices, bills of lading, Exporter's Certificate, etc.) and will disburse the proceeds of the loan for eligible goods and services. In order to obtain approval of the disbursement, the lender will access and complete an electronic questionnaire through EXIM Bank's online application system (EXIM Online). Using the form, the lender will input key data and request EXIM Bank's approval of the disbursement. EXIM Bank's action (approved or denied) is posted on the lender's history page. The information collected in the questionnaire will assist EXIM Bank in determining that each disbursement under a Medium-Term Guarantee meets all the terms and conditions for approval. The information collection tool can be reviewed at: https:// exim.gov/sites/default/files/pub/pending/eib12-01.pdf.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs.'' This draft guidance is intended to provide recommendations for the design and conduct of studies evaluating the adhesive performance of a Transdermal Delivery System or a topical patch (collectively, TDS). This guidance, once finalized, is intended to provide updated recommendations for the design and conduct of adhesion studies submitted in support of an Abbreviated New Drug Application (ANDA) for a TDS.

NMFS is prohibiting directed fishing for Kamchatka flounder in the Bering Sea and Aleutian Islands management area (BSAI). This action is necessary to prevent exceeding the 2016 Kamchatka flounder initial total allowable catch (ITAC) in the BSAI.

In accordance with the Marine Mammal Protection Act (MMPA) regulations, we, the National Marine Fisheries Service (NMFS), hereby give notification that NMFS has issued an Incidental Harassment Authorization (IHA) to Glacier Bay National Park (Glacier Bay NP), to take marine mammals, by Level B harassment, incidental to conducting seabird monitoring and research activities in Alaska, May through September, 2016.

The Commission hereby gives notice of the institution of investigations and commencement of preliminary phase antidumping and countervailing duty investigation Nos. 701-TA-562 and 731-TA-1329 (Preliminary) pursuant to the Tariff Act of 1930 (``the Act'') to determine whether there is a reasonable indication that an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of imports of ammonium sulfate from China, provided for in subheading 3102.21.00 of the Harmonized Tariff Schedule of the United States, that are alleged to be sold in the United States at less than fair value and alleged to be subsidized by the Government of China. Unless the Department of Commerce extends the time for initiation, the Commission must reach a preliminary determination in antidumping and countervailing duty investigations in 45 days, or in this case by July 11, 2016. The Commission's views must be transmitted to Commerce within five business days thereafter, or by July 18, 2016.

Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act (FACA) that a meeting of the Hawai[revaps]i State Advisory Committee (Committee) to the Commission will be held at 9:00 p.m. (Hawaiian Time) Tuesday, June 14, 2016, for the purpose of considering and voting upon a new topic for the Hawai[revaps]i State Advisory Committee's new project for FY 2016. This meeting is available to the public through the following toll-free call-in number: 888-452-4023; when prompted, please provide conference ID number: 4285649. Any interested member of the public may call this number and listen to the meeting. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977-8339 and providing the Service with the conference call number and conference ID number. Hearing-impaired persons who will attend the meeting and require the services of a sign language interpreter should contact the Regional Office at least ten (10) working days before the scheduled date of the meeting. Members of the public are entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments. The comments must be received in the Western Regional Office of the Commission by Thursday, July 14, 2016. The address is Western Regional Office, U.S. Commission on Civil Rights, 300 N. Los Angeles Street, Suite 2010, Los Angeles, CA 90012. Persons wishing to email their comments may do so by sending them to Angela French-Bell, Regional Director, Western Regional Office, at abell@usccr.gov. Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at https:// facadatabase.gov/committee/meetings.aspx?cid=244. Please click on the ``Meeting Details'' and ``Documents'' links. Records generated from this meeting may also be inspected and reproduced at the Western Regional Office, as they become available, both before and after the meeting. Persons interested in the work of this Committee are directed to the Commission's Web site, https://www.usccr.gov, or may contact the Western Regional Office at the above email or street address.

Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act (FACA) that a meeting of the Alaska State Advisory Committee (Committee) to the Commission will be held at 12:00 p.m. (Alaska Time) Thursday, June 23, 2016 for the purpose of considering and voting upon a written draft proposal for the Alaska State Advisory Committee's new project for FY 2016 identifying possible barriers in the election process that may disparately impact Alaskan Natives and their right to vote, and the impact of recent settlements upon voting access for Alaskan Natives. This meeting is available to the public through the following toll- free call-in number: Toll-Free Phone Number: 888-572-7034; when prompted, please provide conference ID number: 4694388. Any interested member of the public may call this number and listen to the meeting. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977-8339 and providing the Service with the conference call number and conference ID number. Hearing-impaired persons who will attend the meeting and require the services of a sign language interpreter should contact the Regional Office at least ten (10) working days before the scheduled date of the meeting. Members of the public are entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments within thirty (30) days of the meeting. The comments must be received in the Western Regional Office of the Commission by Friday, July 22, 2016. The address is Western Regional Office, U.S. Commission on Civil Rights, 300 N. Los Angeles Street, Suite 2010, Los Angeles, CA 90012. Persons wishing to email their comments may do so by sending them to Angela French-Bell, Regional Director, Western Regional Office, at abell@usccr.gov. Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at https:// facadatabase.gov/committee/meetings.aspx?cid=234. Please click on the ``Meeting Details'' and ``Documents'' links. Records generated from this meeting may also be inspected and reproduced at the Western Regional Office, as they become available, both before and after the meeting. Persons interested in the work of this Committee are directed to the Commission's Web site, https://www.usccr.gov, or may contact the Western Regional Office at the above email or street address.

The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.

The Environmental Protection Agency (EPA) is proposing to approve changes to the State Implementation Plan (SIP) submitted by the State of Tennessee through the Tennessee Department of Environment and Conservation (TDEC) on February 8, 2016, for parallel processing. This draft SIP revision seeks to lower applicability thresholds for certain sources subject to Federal Stage I requirements, remove the Stage II vapor control requirements, and add requirements for decommissioning gasoline dispensing facilities, as well as requirements for new and upgraded gasoline dispensing facilities in the Nashville, Tennessee Area (hereinafter also known as the ``Middle Tennessee Area''). EPA has preliminarily determined that Tennessee's February 8, 2016, draft SIP revision is approvable because it is consistent with the Clean Air Act (CAA or Act).

The Environmental Protection Agency (EPA) announces upcoming public meetings of the Clean Air Act Advisory Committee (CAAAC). The EPA established the CAAAC on November 19, 1990, to provide independent advice and counsel to EPA on policy issues associated with implementation of the Clean Air Act of 1990. The Committee advises on economic, environmental, technical, scientific and enforcement policy issues.

This notice advises the public that we, the U.S. Fish and Wildlife Service (FWS) and the National Park Service (NPS), as lead agencies, are withdrawing our proposal to establish the Niobrara Confluence and Ponca Bluffs Conservation Areas in Nebraska and South Dakota.

In accordance with the Paperwork Reduction Act of 1995, the Forest Service is seeking comments on the revision of a currently approved information collection, form FS-7700-40, Application for Permit, Non-Federal Commercial Use of Roads Restricted by Order. The revised information collection is entitled, ``Application for a Permit for Use of Roads, Trails, or Areas Restricted by Regulation or Order.'' The Forest Service is also seeking renewal of an associated existing, form FS- 7700-48, Permit for Use of Roads, Trails, or Areas Restricted by Regulation or Order, and renewal of an associated existing information collection, form FS-7700-41, Non-Federal Commercial Road Use Permit.