2014 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or we) is proposing to amend our 2013 proposed rule for Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals. In that 2013 proposed rule, we proposed to add CGMP requirements for animal food and to add requirements for certain domestic and foreign facilities to establish and implement hazard analysis and risk-based preventive controls for food for animals. We are taking this action because the input we have received from public comments has led to significant changes in our current thinking on certain key provisions of this proposed rule. We are reopening the comment period only with respect to specific issues identified in this proposed rule.

NMFS announces that the State of Maine is transferring a portion of its 2014 commercial bluefish quota to the Commonwealth of Massachusetts. By this action, NMFS adjusts the quotas and announces the revised commercial quota for each state involved.

We, NMFS, announce a 12-month finding on a petition to list the humphead wrasse (Cheilinus undulatus) as threatened or endangered under the Endangered Species Act (ESA). We have completed a comprehensive status review of the humphead wrasse in response to this petition. Based on the best scientific and commercial information available, including the status review report (Graham et al., 2014), we have determined that the species does not warrant listing at this time. We conclude that the humphead wrasse is not currently in danger of extinction throughout all or a significant portion of its range and is not likely to become so within the foreseeable future. We also announce the availability of the humphead wrasse status review report.

The U.S.-China Commission published a document in the Federal Register on July 07, 2014, concerning notice of open meetings to be held in Washington, DC to review and edit drafts of the 2014 Annual Report to Congress. The date for one meeting has changed.

In accordance with the Paperwork Reduction Act of 1995 (PRA), the Consumer Financial Protection Bureau (Bureau) is proposing a new information collection titled, ``Owning a Home Evaluation Study.''

On March 24, 2014, the Department of Commerce (``Department'') published the Preliminary Results of the administrative review of the antidumping duty order on certain frozen warmwater shrimp from the People's Republic of China (``PRC''), covering the period of review (``POR'') from February 1, 2012, through January 31, 2013.\1\ We determine that the application of total adverse facts available (``AFA'') to Zhanjiang Newpro Foods., Ltd. (``Newpro'') and Hilltop International (``Hilltop''), as part of the PRC-wide entity, is appropriate in this review.

In accordance with the Privacy Act of 1974, as amended, 5 U.S.C. 552a, the Department of the Treasury gives notice that it proposes to add a new system of records to its inventory, ``Treasury/ DO. 411Intelligence Enterprise Files,'' to be maintained by the Office of Intelligence and Analysis.

The Coast Guard is establishing a temporary safety zone on the Fox River in Green Bay, Wisconsin. This safety zone is intended to restrict vessels from a portion of the Fox River due to demolition work on a railroad bridge. This temporary safety zone is necessary to protect the surrounding public and vessels from the hazards associated with the bridge demolition.

The Digital Accountability and Transparency Act of 2014 (DATA Act) was enacted for purposes that include expanding the Federal Funding Accountability and Transparency Act of 2006 (FFATA) to require the disclosure of direct Federal agency expenditures and information that links ``Federal . . . spending information to programs of Federal agencies to enable taxpayers and policy makers to track Federal spending more effectively.'' Public Law 113-101, 2(1). FFATA, as amended by the DATA Act, requires the Secretary of the Treasury (Treasury) and the Director of the Office of Management and Budget (OMB), in consultation with the heads of Federal agencies, to ``establish Government-wide financial data standards for any Federal funds made available to or expended by Federal agencies and entities receiving Federal funds.'' 31 U.S.C. 6101, note, Sec. 4(a)(1). Treasury and OMB shall consult with public and private stakeholders in establishing the Government-wide financial data standards (data standards). 31 U.S.C. 6101, note, 4(d). The DATA Act provides that Treasury and OMB shall issue guidance to Federal agencies on the established data standards no later than one year after DATA Act enactment, i.e., by May 9, 2015. Under this Notice, Treasury asks for input from public and private stakeholders on several data standards topics and questions, specifically on data exchange, to better ensure the data standards to be established by Treasury and OMB are informed and useful, and to ensure compliance with DATA Act consultation requirements. Treasury will share all input or information received with OMB to ensure the proper establishment of data standards by Treasury and OMB, consistent with DATA Act requirements.

The Executive Director of the Joint Board for the Enrollment of Actuaries gives notice of a closed meeting of the Advisory Committee on Actuarial Examinations.

The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency's Division of Dockets Management.

The Commodity Futures Trading Commission (CFTC) announces that on October 9, 2014, from 1:30 p.m. to 5:00 p.m. the Global Markets Advisory Committee (GMAC) will hold a public meeting at the CFTC's Washington, DC headquarters. The meeting will focus on issues related to clearing Non-Deliverable Forwards (NDFs) and the digital currency bitcoin. The meeting will consist of two panels. The first panel will discuss whether a clearing mandate is appropriate for NDFs, with a particular focus on how such a mandate would impact foreign exchange contracts. The second panel will discuss the CFTC's jurisdiction with respect to derivatives contracts that reference the digital currency bitcoin.

The Food and Drug Administration (FDA) is announcing a public meeting and scientific workshop, both of which will provide an opportunity for public comment on the topic of Female Sexual Interest/ Arousal Disorder (FSIAD), the most common form of female sexual dysfunction. FSIAD is a diagnosis that combines two previously distinct disordershypoactive sexual desire disorder (HSDD) and female sexual arousal disorder (FSAD). The public meeting will take place on October 27, 2014, and is part of FDA's Patient-Focused Drug Development performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). At this meeting, FDA will obtain patients' perspectives on the impact that FSIAD (or a prior diagnosis of HSDD or FSAD) has on their daily lives, as well as their perspectives on the available therapies for these conditions. The scientific workshop will take place on October 28, 2014, and will provide an opportunity for FDA to seek input from experts on scientific issues important to the clinical development of drug products intended to treat FSIAD.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry: Animal Drug User Fees and Fee Waivers and Reductions'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

In compliance with the Paperwork Reduction Act of 1995, the Assistant SecretaryIndian Affairs is submitting to the Office of Management and Budget (OMB) a request for approval for the collection of information for the Reporting System for Public Law 102-477 Demonstration Project. The information is currently authorized by OMB Control Number 1076-0135, which expires January 31, 2017.

The Coast Guard will enforce the annual Blue Water Resort and Casino (BWRC) Parker Enduro marine event and associated waterway restriction special local regulations on October 24-26, 2014. This event occurs in the navigable waters of the Colorado River in Parker, Arizona between river miles 179 and 185 (between the Roadrunner Resort and the Headgate Dam). These special local regulations are necessary to provide for the safety of the participants, crew, spectators, 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 Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices.'' This draft guidance provides industry and Agency staff with recommendations for the suggested format and content of an abbreviated 510(k) submission for early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization devices. This draft guidance is not final nor is it in effect at this time.

This document provides Administrative Guidelines (Guidelines) which qualified Housing Credit Agencies (HCAs) must follow in implementing subsidy layering reviews in accordance with the requirements of the Housing and Economic Recovery Act of 2008 (HERA), in those cases where the HCA elects to conduct the review. In certain instances, described in this notice, HUD will follow these Guidelines in implementing subsidy layering reviews to satisfy the requirements of section 102(d) of the Department of Housing and Urban Development Reform Act of 1989 (HUD Reform Act). The requirements in this notice do not supersede the subsidy layering requirements of other Federal programs. This notice sets forth the guidelines for conducting subsidy layering reviews for mixed-finance public housing projects and for newly constructed and rehabilitated structures combining other forms of government assistance with project-based voucher assistance under section 8 of the United States Housing Act of 1937 (1937 Act).