September 28, 2015 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing a public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2018 through 2022. BsUFA authorizes FDA to collect user fees for the process for the review of biosimilar biological products. The current legislative authority for BsUFA expires in September 2017. At that time, new legislation will be required for FDA to continue collecting user fees in future fiscal years. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA begin the BsUFA reauthorization process by publishing a notice in the Federal Register requesting public input and holding a public meeting where the public may present its views on the reauthorization. FDA invites public comment on the BsUFA performance goals as the Agency begins the process to reauthorize the program in FYs 2018-2022.

The National Science Foundation (NSF) is required to publish a notice of permit applications received to conduct activities regulated under the Antarctic Conservation Act of 1978. NSF has published regulations under the Antarctic Conservation Act at Title 45 Part 670 of the Code of Federal Regulations. This is the required notice of permit applications received.

As part of its regular business meeting held on September 10, 2015, in Binghamton, New York, the Commission took the following actions: (1) Approved or tabled the applications of certain water resources projects; (2) approved a request from Panda Power Funds for transfer of ownership of Hummel Station LLC; (3) accepted a settlement in lieu of penalty from Downs Racing L.P.; and (4) took additional actions, as set forth in the SUPPLEMENTARY INFORMATION below.

The Deputy Director for Policy and Research, delegated the duties of the Director, of the Institute of Education Sciences (Institute) announces the Institute's FY 2016 grant competition for Low-Cost, Short-Duration Evaluation of Education Interventions and Low- Cost, Short-Duration Evaluation of Special Education Interventions. The Deputy Director for Policy and Research takes this action under the Education Sciences Reform Act of 2002. The Institute's purpose in awarding these grants is to support rigorous evaluations of education interventions that State educational agencies (SEAs) or local educational agencies (LEAs) believe will produce meaningful improvements in student outcomes within a short period (for example, within a single semester or academic year), that can be conducted at low cost, and that will provide policymakers with valid and useful results more rapidly than is typically achieved in education research.

The Food and Drug Administration (FDA) is announcing a public meeting and an opportunity for public comment on the topic of the labeling for lower-dose estrogen products delivered vaginally, intended to treat moderate to severe symptoms of vulvar and vaginal atrophy (VVA) due to menopause. Lower-dose estrogen products means products that contain less than the 0.625 milligrams (mg) of conjugated estrogens used in the Women's Health Initiative Study, and estradiol products containing 0.0375 mg and below. Lower-dose estrogen products are now approved for the treatment of moderate to severe symptoms of VVA due to menopause, and some in the scientific/medical community have questioned whether the current ``Boxed Warnings'' section in the labeling is applicable in whole or in part to these lower-dose estrogen products. This meeting, a scientific workshop, will provide an opportunity for FDA to seek input from experts on the Boxed Warnings section, estrogen exposure data, and pharmacokinetic (PK)/ pharmacodynamic (PD) relationships relative to labeling lower-dose estrogen-alone products intended to treat moderate to severe symptoms of VVA due to menopause.

The Copyright Royalty Judges publish final regulations that set the rates and terms for the digital performances of sound recordings by certain noncommercial educational webcasters and for the making of ephemeral recordings necessary to facilitate those transmissions for the period commencing January 1, 2016, and ending on December 31, 2020.

The Environmental Protection Agency has submitted an information collection request (ICR), ``NESHAP for Radionuclides (Renewal)'' (EPA ICR No. 1100.15, OMB Control No. 2060-0249) 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. Public comments were previously requested via the Federal Register 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.

On June 8, 2015, FEMA published in the Federal Register a proposed flood hazard determination notice that contained an erroneous table. This notice provides corrections to that table, to be used in lieu of the information published at 80 FR 32396. The table provided here represents the proposed flood hazard determinations and communities affected for Humboldt County, California, and Incorporated Areas.

The Department of the Treasury, 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 a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A). Currently the Bureau of the Fiscal Service within the Department of the Treasury is soliciting comments concerning the Report/Application for Relief on Account of Loss, Theft, or Destruction of U.S. Bearer Securities (Organizations).

The Department of the Treasury, 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 a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A). Currently the Bureau of the Fiscal Service within the Department of the Treasury is soliciting comments concerning the Certificate of Identity.

This report to Congress is provided in accordance with Section 608(b) of the Millennium Challenge Act of 2003, as amended, 22 U.S.C. 7707(b) (the ``Act'').

The NCUA intends to submit the following information collection to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chapter 35). This information collection is published to obtain comments from the public. NCUA previously amended its credit union service organization (CUSO) regulation to increase transparency and address certain safety and soundness concerns. The final rule extends certain requirements of the CUSO regulation to federally insured, state-chartered credit unions and imposes new requirements on federally insured credit unions (FICUs). Under the amended rule, FICUs with an investment in, or loan to, a CUSO must obtain a written agreement with the CUSO addressing accounting, financial statements, audits, reporting, and legal opinions. The rule limits the ability of a ``less than adequately capitalized'' FICU to recapitalize an insolvent CUSO. All CUSOs are required to annually provide basic profile information to NCUA and the appropriate state supervisory authority (SSA). CUSOs engaging in certain complex or high-risk activities are also required to report more detailed information, including audited financial statements and customer information.