July 28, 2015 – Federal Register Recent Federal Regulation Documents

The Coast Guard will enforce a marine event special local regulation on the navigable waters of Mission Bay, San Diego, CA in support of the annual San Diego Bayfair from September 18, 2015 to September 20, 2015, from 7 a.m. to 6 p.m. This action is necessary to provide for the safety of the participants, crew, spectators, safety vessels, and general users of the waterway. During the enforcement period, persons and vessels are prohibited from entering into, transiting through, or anchoring within this regulated area unless authorized by the Captain of the Port, or his designated representative.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, 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. This notice invites comment on a proposed information collection entitled Monitoring and Reporting System for the Prescription Drug Overdose Prevention for States Cooperative Agreement. CDC will use the information collected to monitor cooperative agreement awardees and to identify challenges to program implementation and achievement of outcomes.

Notice is hereby given that Briana Witteveen, Ph.D., University of Alaska Fairbanks, School of Fisheries and Ocean Sciences, 118 Trident Way, Kodiak, AK 99615, has been issued a minor amendment to Scientific Research Permit No. 14296-01.

Notice is hereby given that a permit has been issued to NMFS Office of Protected Resources, Marine Mammal Health and Stranding Response Program (Responsible Party: Teri Rowles, D.V.M., Ph.D.), 1315 East-West Highway, Silver Spring, MD 20910, to take, import, and export marine mammals and marine mammal parts for research and enhancement purposes.

The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), is announcing the availability of a draft guidance for industry entitled ``Request for Quality Metrics'' and a public meeting regarding the Agency's plans associated with a quality metrics reporting program. The draft guidance and public meeting are intended to gain stakeholders' perspectives on various aspects of the development and planned implementation of a quality metrics program launched under the authority of the Food, Drug, and Cosmetic Act (the FD&C Act). The guidance includes an explanation of how FDA intends to use quality metrics data to further develop the FDA's risk-based inspection scheduling, to identify situations in which there may be a risk for drug supply disruption, to improve the efficiency and effectiveness of establishment inspections, and to improve FDA's evaluation of drug manufacturing and control operations. FDA expects that the initial use of the metrics will be to consider a decreased surveillance inspection frequency for certain establishments. For example, establishments that have highly controlled manufacturing processes have the potential to be inspected less often (as a lower priority for inspection) than similar establishments that demonstrate uncontrolled processes (as a higher priority for inspection). In addition, FDA intends to consider whether these metrics may provide a basis for FDA to use improved risk-based principles to determine the appropriate reporting category for postapproval manufacturing changes. FDA intends to consider the input from this public meeting as we finalize this guidance and the planned implementation of this program, including FDA's initial set of requests for quality metrics data.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will hold a meeting. The meeting will be open to the public.

The Environmental Protection Agency has submitted an information collection request (ICR), ``NESHAP for Miscellaneous Metal Parts and Products (40 CFR part 63, subpart MMMM) (Renewal)'' (EPA ICR No. 2056.05, OMB Control No. 2060-0486), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This is a proposed extension of the ICR, which is currently approved through July 31, 2015. Public comments were previously requested via the Federal Register (79 FR 30117) on May 27, 2014 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

This notice publishes the Indian Gaming Compact between the State of New Mexico and the Pueblo of Isleta governing Class III gaming (Compact) taking effect.

The National Park Service has prepared and approved a Record of Decision for the Final Environmental Impact Statement (EIS) for the Wilderness Management Plan for Lake Mead National Recreation Area. Approval of the Wilderness Management Plan concludes an extensive conservation planning and environmental impact analysis effort that began during 2006. The requisite no-action ``wait period'' was initiated on February 27, 2015, with the Environmental Protection Agency's Federal Register announcement of the filing of the Final EIS.

NMFS is closing the U.S. pelagic longline fishery for bigeye tuna in the western and central Pacific Ocean as a result of the fishery reaching the 2015 catch limit. This action is necessary to prevent additional fishing pressure on this fish stock.

NMFS is adjusting the Swordfish (SWO) General Commercial permit retention limits for the Northwest Atlantic, Gulf of Mexico, and U.S. Caribbean regions for the remainder of 2015, unless otherwise noticed. The SWO General Commercial permit retention limit in each of these three regions is increased to six SWO per vessel per trip. The SWO General Commercial permit retention limit in the Florida SWO Management Area will remain unchanged at zero SWO per vessel per trip. This adjustment applies to SWO General Commercial permitted vessels and HMS Charter/Headboat permitted vessels when on a non-for-hire trip. This action is based upon consideration of the applicable inseason regional retention limit adjustment criteria.

In compliance with the Paperwork Reduction Act of 1995, the Naval Sea Systems Command (NAVSEA), Cost Engineering and Industrial Analysis Group (SEA 05C) announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

The Commission is proposing rules which establish the Commission's process for developing views to the Secretary of State on certain international mail matters. The proposed rules focus on those proposals concerning international mail that could affect a market dominant rate or classification. The Commission invites public comment on the proposed rules.

The DoD is publishing this notice to announce two days of meetings of the National Commission on the Future of the Army (``the Commission''). The meetings will be partially closed to the public.

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.

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 Department of Justice (DOJ), Office of Justice Programs, Bureau of Justice Assistance, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.

This Notice is to invite applications for grants to provide technical assistance for rural transportation (RT) systems under the Rural Business Development Grant (RBDG) program pursuant to 7 CFR part 4280, subpart E, 2 CFR chapter IV and 2 CFR part 200 for fiscal year (FY) 2015. Funding shall be made available to qualified national organizations to provide technical assistance for rural transportation (RT) systems and for RT systems to Federally Recognized Native American Tribes' (FRNAT) (collectively ``Programs'') from funds appropriated for the RBDG program. The Rural BusinessCooperative Service (RBS) will administer these awards under the RBDG program and 7 U.S.C. 1932(c) for FY 2015. This Notice is subject to the terms and funds for the Programs made available in the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) (FY 2015 appropriation). All applicants are responsible for any expenses incurred in developing their applications.

The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) will submit the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection is published to obtain comments from the public and affected agencies. This proposed information collection was previously published in 80 FR 29747 on May 22, 2015, allowing for a 60-day comment period.