2015 – Federal Register Recent Federal Regulation Documents

On July 17, 2014, the President announced the Build America Investment Initiative, a government-wide effort to increase infrastructure investment and economic growth by engaging with state and local governments and private sector investors to encourage collaboration, expand the market for public-private partnerships (P3s) and put Federal credit programs to greater use. As part of that effort, the Presidential Memorandum tasked the U.S. Department of Transportation (USDOT) to establish the Build America Transportation Investment Center (BATIC), a one-stop-shop for state and local governments, public and private developers and investors seeking to utilize innovative financing and P3s to deliver transportation projects. USDOT has made significant progress in its work to expand access to USDOT credit programs, spread innovation through tools that build capacity across the country, and deliver project-focused technical assistance to help high-impact projects develop plans, navigate Federal programs and requirements, and evaluate and pursue financing opportunities. This includes an effort to provide a range of technical assistance tools to project sponsors, including a series of model contract provisions for popular P3 project types. Development of these tools fulfills a requirement under Moving Ahead for Progress in the 21st Century Act (MAP-21) that FHWA to develop public-private partnership (P3) transaction model contracts for the most popular type of P3s for transportation projects. Based on public input favoring an educational, rather than prescriptive, contract model, FHWA is publishing a series of guides describing terms and conditions typically adopted in P3 concession agreements. The FHWA values public input in the development of the model contract guides, and seeks continuing input. All documents in this series share the same Docket Number (FHWA- 2014-0006). To address the most popular types of P3s, FHWA is producing separate guides to the two most common agreements for concessionaire compensation: user tolls and availability payments (APs). For the purpose of public comment, the Toll Concessions Guide was divided into two parts. The first part, addressing the highest profile (``Core'') provisions, was published in final form on September 10, 2014. The second part (the ``Addendum''), addressing additional substantive provisions, was published in draft form on January 16, 2015. As described below, FHWA is deferring publication of the final version of the Addendum in order to obtain public comment on additional material (provided with this announcement) relevant to the concessions guides. With this notice, FHWA publishes a Draft Availability Payment Concessions P3 Model Contract Guide (``AP Concessions Guide'') so that the general public and interested stakeholders may provide comments. The AP Concessions Guide can be found on the Docket (FHWA-2014-0006) and at the following link:https://www.fhwa.dot.gov/ipd/pdfs/p3/ apguide.pdf. This model contract guide has been prepared solely for informational purposes and should not be construed as a statement of DOT or FHWA policy. In addition, a separate chapter on Labor Best Practices recommended by the U.S. Department of Labor has been added to the Docket and is available at the following link: https://www.fhwa.dot.gov/ipd/pdfs/p3/ laborbestpractices.pdf. This chapter discusses labor provisions recommended by the U.S. Department of Labor for all P3 concession agreements, following a collaboration with USDOT, regardless of source of funding (i.e., Federal, State, or private) or form of compensation (i.e., user tolls or APs). The FHWA intends to incorporate this chapter into the final contract guides for both user toll and AP concessions; therefore, FHWA is seeking public comment on this document prior to finalizing the Toll Concession Addendum.

Pursuant to the Federal Advisory Committee Act, this constitutes notice of the upcoming meeting of the Grain Inspection, Packers and Stockyards Administration (GIPSA) Grain Inspection Advisory Committee (Advisory Committee). The Advisory Committee meets annually to advise the GIPSA Administrator on the programs and services that GIPSA delivers under the U.S. Grain Standards Act. Recommendations by the Advisory Committee help GIPSA better meet the needs of its customers who operate in a dynamic and changing marketplace.

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 the proposed revision of the National Ambulatory Medical Care Survey (NAMCS). The purpose of NAMCS is to meet the needs and demands for statistical information about the provision of ambulatory medical care services in the United States.

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 the Personal Protective Equipment Information (PPE-Info) Database which is a compendium of personal protective equipment (PPE) Federal regulations and consensus standards.

The Food and Drug Administration (FDA or we) is announcing the availability of a guidance entitled ``Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic or Paper Format: Guidance for Industry.'' This guidance describes the administrative procedures to be used by commercial processors that manufacture, process, or pack acidified foods (``AF'') and/or thermally processed low-acid foods packaged in hermetically sealed containers (historically referred to as ``low-acid canned foods'' or ``LACF''). These changes include new registration and food process filing forms and a new ``smart form'' system for electronic submission of the process filing forms. Registration and process filing are required by the AF and LACF provisions of our regulations. This guidance also provides general information about how to use FDA's systems for electronic submission of the applicable forms. In addition, this guidance describes administrative procedures for voluntary registration and voluntary submissions when a commercial processor has determined that its product is not an acidified food or a low-acid canned food, and is therefore not subject to our regulations for AF and LACF. Further, this guidance describes a voluntary process whereby, upon request, we review data and other information that relate to a new processing method or new equipment.

The Animal and Plant Health Inspection Service proposes to revise an existing system of records in its inventory of record systems subject to the provisions of the Privacy Act of 1974, as amended. The Animal and Plant Health Inspection Service is revising Wildlife Services Management Information System, USDA-APHIS-9, to revise the routine uses, expand the categories of records in the system, and the location of the system. This notice is necessary to meet the requirements of the Privacy Act to publish in the Federal Register notice of the existence and character of record systems maintained by the agency.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Integrated Summary of Effectiveness.'' This guidance describes how an integrated summary of effectiveness (ISE) should be prepared by industry for new drug applications (NDAs) and biologics license applications (BLAs). This guidance is intended to improve the quality of drug applications by describing what efficacy information should be submitted so that FDA can make a regulatory decision on an application. This guidance finalizes the draft guidance issued August 28, 2008.

The U.S. Department of Transportation's (DOT), Federal Transit Administration (FTA) announces the selection of projects for the Fiscal Year (FY) 2015 Innovative Public Transportation Workforce Development Program (Workforce Development Program). Under the prior authorization, the Workforce Development Program was authorized under 49 U.S.C. 5322. Under the Moving Ahead for Progress in the 21st Century (MAP-21) Act, the program is authorized at 49 U.S.C. 5322(b). These projects are funded with a combination of $4 million of unallocated Section 5314 Federal funds appropriated in FY 2012, and a total of $5.5 million authorized under MAP-21 and appropriated in FYs 2013, 2014, and 2015 for Section 5322. These program dollars will provide financial assistance to promote diverse and innovative workforce development models and programs that specifically target unemployment training programs, outreach to increase minority and female employment, and training for minority business opportunities.

As required by the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Consumer Product Safety Commission (``CPSC'' or ``Commission'') requests comments on a proposed extension of approval of a collection of information under the safety standard for swings, approved previously under OMB Control No. 3041-0155. The Commission will consider all comments received in response to this notice before requesting an extension of this collection of information from the Office of Management and Budget (``OMB'').

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.

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a final guidance for industry entitled ``Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), an outsourcing facility must submit adverse event reports to FDA. This guidance explains FDA's current thinking on adverse event reporting for these outsourcing facilities.

The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), 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.

DoD, GSA, and NASA are proposing to amend the Federal Acquisition Regulation (FAR) to implement section 814 of the Carl Levin and Howard P. `Buck' McKeon National Defense Authorization Act for Fiscal Year 2015 that requires the head of the contracting activity to approve any determinations to select more than five offerors to submit phase-two proposals for a two-phase design-build construction acquisition that is valued at greater than $4 million.

The National Urban and Community Forestry Advisory Council (Council) will meet in Denver, Colorado. The Council is authorized under section 9 of the Cooperative Forestry Assistance Act, as amended by title XII, section 1219 of Public Law 101-624 (the Act) (16 U.S.C. 2105g) and the Federal Advisory Committee Act (FACA) (5 U.S.C. App. II). Additional information concerning the Council, can be found by visiting the Council's Web site at: https://www.fs.fed.us/ucf/ nucfac.shtml.