2015 – Federal Register Recent Federal Regulation Documents

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

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 revision of the form to remove the statement that chapter 35 recipients cannot choose Electronic Funds Transfer (EFT).

The Bureau of Reclamation has made available the Final Environmental Impact Statement (EIS) on the impacts of implementing the 2008 U.S. Fish and Wildlife Service Biological Opinion and the 2009 National Marine Fisheries Service Biological Opinion, including the Reasonable and Prudent Alternatives, for the Coordinated Long-Term Operation of the Central Valley Project and State Water Project. The preferred alternative identified in the Final EIS will be to continue the operation of the Central Valley Project in coordination with the State Water Project, and implement the 2008 U.S. Fish and Wildlife Service and 2009 National Marine Fisheries Service biological opinions and reasonable and prudent alternatives stated in the No Action Alternative. The Final EIS is in response to the November 16, 2009 and March 5, 2010 rulings by the United States District Court for the Eastern District of California that the Bureau of Reclamation failed to conduct a National Environmental Policy Act review prior to accepting and implementing the Reasonable and Prudent Alternatives from the 2008 U.S. Fish and Wildlife Service and 2009 National Marine Fisheries Service Biological Opinions.

Notice is hereby given that the U.S. International Trade Commission has received a second amended complaint entitled Certain Woven Textile Fabrics and Products Containing Same, DN 3088; the Commission is soliciting comments on any public interest issues raised by the second amended complaint or complainant's filing under section 210.8(b) of the Commission's Rules of Practice and Procedure (19 CFR 210.8(b)).

In accordance with the Paperwork Reduction Act of 1995, this notice invites the general public and other public agencies to comment on this proposed information collection. This collection is a revision of a currently approved collection. The purpose of the Uniform Grant Application Package for Discretionary Grant Programs is to provide a standardized format for the development of all Requests for Applications for discretionary grant programs released by the Food and Nutrition Service (FNS) Agency and to allow for a more expeditious OMB clearance process.

The Small Business Administration (SBA) is publishing this notice to comply with requirements of the Paperwork Reduction Act (PRA) (44 U.S.C. Chapter 35), which requires agencies to submit proposed reporting and recordkeeping requirements to OMB for review and approval, and to publish a notice in the Federal Register notifying the public that the agency has made such a submission. This notice also allows an additional 30 days for public comments.

The Environmental Protection Agency (EPA) is proposing to approve State Implementation Plan (SIP) submissions from the states of Colorado, Montana, North Dakota and South Dakota that are intended to demonstrate that the SIP for each respective state meets certain interstate transport requirements of the Clean Air Act (Act or CAA) for the 2008 8-hour ozone National Ambient Air Quality Standards (NAAQS). These submissions address the requirement that each SIP contain adequate provisions prohibiting air emissions that will have certain adverse air quality effects in other states. The EPA is proposing to approve these SIPs for all four states as containing adequate provisions to ensure that air emissions in the states do not significantly contribute to nonattainment or interfere with maintenance of the 2008 8-hour ozone NAAQS in any other state.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Nonprescription Sunscreen Drug ProductsContent and Format of Data Submissions to Support a GRASE Determination Under the Sunscreen Innovation Act''. This draft guidance addresses FDA's current thinking on how we will determine whether a sponsor's submission of safety and efficacy data is sufficiently complete to support a substantive review and determination under the Sunscreen Innovation Act (SIA) that an active ingredient is or is not generally recognized as safe and effective (GRASE) for use in nonprescription sunscreen products. This guidance is being issued in accordance with the SIA.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process.'' This draft guidance explains the process by which FDA intends to carry out the section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Sunscreen Innovation Act (SIA), which governs the convening of advisory committees and the number of requests to be considered per meeting. The recommendations in this draft guidance apply to 586A requests submitted under the FD&C Act and to pending requests as defined by the SIA that seek a determination from FDA on whether a nonprescription sunscreen active ingredient, or a combination of nonprescription sunscreen active ingredients, is generally recognized as safe and effective for use under specified conditions and should be included in the over-the-counter (OTC) sunscreen drug monograph. The SIA describes specific circumstances under which FDA is ``not'' required to convene or submit requests to the Nonprescription Drugs Advisory Committee (NDAC). We are issuing this draft guidance pursuant to the SIA, which directs FDA to issue four guidances on various topics, including this draft guidance.

The Food and Drug Administration (FDA) is classifying the prostate lesion documentation system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the prostate lesion documentation system classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

This document announces revisions to the baseline data, opening bid prices and revises FCC Form 177 and 175 filing windows requirements for Auction 1001 and Auction 1002 respectively.

The Department of Commerce (Commerce) announces, in coordination with U.S. Customs and Border Protection (CBP), a test of the International Trade Data System (ITDS) involving the electronic submission to CBP of forms and certifications related to importation of uranium products from the Russian Federation (Russia), using the Document Image System (DIS) of the Automated Commercial Environment (ACE). CBP and Commerce have developed this program to test and assess the electronic transmission to CBP of certain import documentation for incoming shipments subject to the applicable provisions of the Agreement Suspending the Antidumping Investigation on Uranium from the Russian Federation (Suspension Agreement).\1\ The test will involve forms and certifications required by the Suspension Agreement for shipments of uranium products from Russia that must be filed with CBP at the time of entry when an entry has been filed in ACE. Under this test, such documents must be submitted using DIS. This test applies to all entry types filed in ACE at any port. The electronic submission to CBP of such documentation through DIS is in addition to, and does not replace, the timely filing of the documentation required by the Suspension Agreement with Commerce through Enforcement and Compliance's (E&C) electronic filing system, Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS), available at access.trade.gov.\2\

In compliance with the National Environmental Policy Act of 1969, as amended (NEPA), the Bureau of Land Management (BLM) Colorado River Valley Field Office (CRVFO), Silt, Colorado, prepared a Draft Environmental Impact Statement (EIS) reconsidering previous decisions to issue 65 leases on lands within the White River National Forest (WRNF).

Copies of the Bonneville Purchasing Instructions (BPI), which contain the policy and establish the procedures that BPA uses in the solicitation, award, and administration of its purchases of goods and services, including construction, are available in printed form or at the following Internet address: https://www.bpa.gov/corporate/business/ bpi. Copies of the Bonneville Financial Assistance Instructions (BFAI), which contain the policy and establish the procedures that BPA uses in the solicitation, award, and administration of financial assistance instruments (principally grants and cooperative agreements), are available in printed form or available at the following Internet address: https://www.bpa.gov/corporate/business/bfai.

In accordance with the Federal Land Policy and Management Act of 1976 as amended (FLPMA) and the Federal Advisory Committee Act of 1972 (FACA), the Bureau of Land Management (BLM) Alaska Resource Advisory Council (RAC) will meet as indicated below.

EPA issued a notice in the Federal Register of September 25, 2015, opening a comment period on draft human health and ecological risk assessments for certain organophosphate pesticides listed in the Table in this document, along with additional chemicals. This document extends the comment period by 45 days for just those chemicals listed in the Table in this document, i.e., from November 24, 2015 to January 8, 2016. This comment period is being extended in response to comments received by the Agency.