November 2014 – Federal Register Recent Federal Regulation Documents
Results 451 - 500 of 2,131
TPG Specialty Lending, Inc., et al.; Notice of Application
Summary of Application: Applicants request an order to permit a business development company (``BDC'') to co-invest in portfolio companies with affiliated investment funds.
Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act; Final Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry entitled ``Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.'' The guidance addresses new provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug Quality and Security Act (DQSA). The guidance is intended to assist human drug compounders that elect to register as outsourcing facilities in registering, re-registering, or de-registering with FDA. The guidance provides information on how an outsourcing facility should submit facility registration information electronically in structured product labeling (SPL) format using FDA's electronic submission system. This guidance reflects the Agency's current thinking on the issues addressed by the guidance.
Fees for Human Drug Compounding Outsourcing Facilities Under the FD&C Act; Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry entitled ``Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act.'' The guidance is intended for entities that compound human drugs and elect to register as outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as added by the Drug Quality and Security Act (DQSA). Entities that elect to register as outsourcing facilities must pay certain fees to be considered outsourcing facilities. This guidance describes the annual establishment fee, the reinspection fee, annual adjustments to fees required by law, how to submit payment, the effect of failure to pay fees, and how to qualify as a small business to obtain a reduction of the annual establishment fee.
Electronic Product Reporting for Human Drug Compounding Outsourcing Facilities; Draft Guidance
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a revised draft guidance entitled ``Electronic Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' The revised draft guidance addresses provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) added by the Drug Quality and Security Act (DQSA) and updates reporting instructions for drug compounders that choose to register as outsourcing facilities. Such compounders must report information on the drugs they have compounded in Structured Product Labeling (SPL) format using FDA's electronic submissions system. This revised draft guidance supersedes a draft guidance entitled ``Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.''
The Critical Infrastructure Partnership Advisory Council
The Department of Homeland Security (DHS) announced the establishment of the Critical Infrastructure Partnership Advisory Council (CIPAC) in a Federal Register Notice (71 FR 14930-14933) dated March 24, 2006, which identified the purpose of CIPAC, as well as its membership. This notice provides: (i) Quarterly CIPAC membership updates; (ii) instructions on how the public can obtain the CIPAC membership roster and other information on the council; and (iii) information on recently completed CIPAC meetings.
Information Collection Activities
In accordance with the Paperwork Reduction Act of 1995, PHMSA invites comments on certain information collections pertaining to hazardous materials transportation for which PHMSA intends to request renewal from the Office of Management and Budget (OMB).
Agency Information Collection Activities: Information Collection Renewal; Submission for OMB Review; Electronic Operations
The OCC, 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 continuing information collection, as required by the Paperwork Reduction Act of 1995 (PRA). In accordance with the requirements of the PRA, the OCC may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. The OCC is soliciting comment concerning renewal of its information collection titled, ``Electronic Operations.'' The OCC is also giving notice that it has sent the collection to OMB for review.
Magnesium Metal From the People's Republic of China: Preliminary Results of Antidumping Duty Administrative Review; 2013-2014
The Department of Commerce (``Department'') is conducting the administrative review of the antidumping duty order on magnesium metal from the People's Republic of China (``PRC''). The period of review (``POR'') is April 1, 2013, through March 31, 2014. This review covers two PRC companies, Tianjin Magnesium International, Co., Ltd. (``TMI'') and Tianjin Magnesium Metal, Co., Ltd. (``TMM''). The Department preliminarily finds that TMI and TMM did not have reviewable entries during the POR. We invite interested parties to comment on these preliminary results.
Prospective Grant of Exclusive License: Development of Autologous Tumor Infiltrating Lymphocyte Adoptive Cells for the Treatment of Metastatic Melanoma
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to the current licensee, Lion Biotechnologies, Inc., which is located in Woodland Hills, California to practice the inventions embodied in the following patent applications and applications claiming priority to these applications:
Findings of Failure To Submit a Complete State Implementation Plan for Section 110(a) Pertaining to the 2010 Nitrogen Oxide (NO2
The Environmental Protection Agency (EPA) is taking final action finding that the District of Columbia and seven states (Alaska, Arkansas, Hawaii, Minnesota, New Jersey, Vermont and Washington) have not submitted complete infrastructure State Implementation Plans (SIPs) that provide the basic Clean Air Act (CAA) program elements necessary to implement the 2010 nitrogen dioxide (NO2) primary national ambient air quality standard (NAAQS). Three out of the seven states (Alaska, Arkansas and Vermont) have not made any submittals. The District of Columbia and the remaining four out of the seven states (Hawaii, Minnesota, New Jersey and Washington) have made submittals that are partially incomplete due to the lack of complete SIP approved Prevention of Significant Deterioration (PSD) permit programs. The purpose of an infrastructure SIP submission is to assure that a state, local or tribal air agency's SIP contains the necessary structural requirements for any new or revised NAAQS. The remaining 43 states have made complete submissions. Each finding of failure to submit a complete infrastructure SIP establishes a 24-month deadline for the EPA to promulgate a Federal Implementation Plan (FIP) to address the outstanding SIP elements unless, prior to the EPA promulgating a FIP, the affected air agency submits, and the EPA approves, a revised SIP that corrects the deficiency. In those areas without a state-adopted PSD permit program, the FIP obligation has already been met through federal regulations that govern PSD permits issued in some cases by the EPA and in other cases by state or local agencies under delegation agreements.
Request for Comment on Draft Vaccines Adverse Event Reporting System (VAERS) 2.0 Form
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), is publishing this notice requesting public comment on the proposed VAERS 2.0 form, which is intended to replace the current VAERS-1 form (https:// vaers.hhs.gov/resources/vaers_form.pdf). CDC and the U.S. Food and Drug Administration (FDA) co-administer the Vaccines Adverse Event Reporting System (VAERS), a post-licensure (i.e., after vaccines have been licensed by the FDA and are being used in the community) reporting system that accepts submitted reports of adverse events that occur after vaccination from healthcare providers, manufacturers, and the public. Healthcare providers and vaccine manufacturers are required to submit VAERS reports. The National Childhood Vaccine Injury Act of 1986, section 2125 of the Public Health Service Act (42 U.S.C. 300aa- 25) authorized VAERS. The current VAERS form has been used since 1990.
New Postal Product
The Commission is noticing a recent Postal Service filing of a contingency pricing adjustment to an outstanding International Business Reply Service Competitive Contract 3 negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Professional U.S. Scouting Organization Operations at U.S. Military Installations Overseas
This rule updates policy and outlines fiscal and logistical support the DoD may provide to qualified scouting organizations operating on U.S. military installations overseas based on Executive Order 12715, Support of Overseas Scouting Activities for Military Dependents and appropriate statute as discussed below. It is DoD policy to cooperate with and assist qualified scouting organizations in establishing and providing facilities and services, within available resources, at locations outside the United States to support DoD personnel and their families.
Notice of Intent To Extend an Information Collection
Under the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3501 et seq.), and as part of its continuing effort to reduce paperwork and respondent burden, the National Science Foundation (NSF) is inviting the general public or other Federal agencies to comment on this proposed continuing information collection. The NSF will publish periodic summaries of proposed projects. Comments: 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 collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of automated collection techniques or other forms of information technology.
Proposed Information Collection; Comment Request; Shipboard Observation Form for Floating Marine Debris
The Department of Commerce, 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 proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Proposed Information Collection; Comment Request; Fishery Capacity Reduction Program Buyback Requests
The Department of Commerce, 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 proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Approval and Promulgation of Implementation Plans; Swinomish Indian Tribal Community; Tribal Implementation Plan
The Environmental Protection Agency (EPA) is approving a Tribal implementation plan (TIP) submitted by the Swinomish Indian Tribal Community (SITC or the Tribe). The SITC TIP regulates open burning practices and establishes a Tribal regulatory program applicable to all persons within the exterior boundaries of the Swinomish Reservation (Reservation). The SITC TIP was submitted to the EPA on June 28, 2012, and supplementary submittals were received on September 24, 2013, November 18, 2013, and January 28, 2014. This action makes the approved portions of the SITC TIP federally enforceable under the Clean Air Act (CAA). Upon the effective date of this action, the SITC TIP will replace the Federal Implementation Plan (FIP) provisions that regulate open burning within the exterior boundaries of the Reservation.
Changes or Corrections to Mail Classification Schedule
The Commission is proposing rules addressing changes and corrections to the Mail Classification Schedule (MCS). The proposed rules establish separate procedures for material changes in services offered in connection with products and corrections to product descriptions. The primary purposes of the proposed rules are to ensure that the MCS accurately describes the current product offerings of the Postal Service and to ensure compliance with the relevant statutory provisions when material changes to product offerings are made. The Commission invites public comment on the proposals.
FCC To Hold Special Commission Meeting; Friday, October 24, 2014
The Commission will consider whether to take an enforcement action.
Television Broadcasting Services; Kansas City, Missouri
A petition for rulemaking was filed by ION Media Kansas City License, Inc. (``ION Media''), the licensee of KPXE-TV, channel 51, Kansas City, Missouri, requesting the substitution of channel 30 for channel 51 at Kansas City. ION Media filed comments reaffirming its interest in the proposed channel substitution and explained that the channel substitution will allow it to serve all viewers currently receiving digital service while eliminating any potential interference with wireless operations in the Lower 700 MHZ A Block located adjacent to channel 51 in Kansas City. ION Media states that it will file an application for a construction permit for channel 30 and implement the change in accordance with the Commission's rules upon adoption of the channel substitution.
Approval and Promulgation of Implementation Plans; State of Washington; Regional Haze State Implementation Plan; Federal Implementation Plan for Best Available Retrofit Technology for Alcoa Intalco Operations, Tesoro Refining and Marketing, and Alcoa Wenatchee
In a final action published on June 11, 2014, the Environmental Protection Agency (EPA) published a final rule in the Federal Register concerning, in part, the promulgation of a Federal Implementation Plan (FIP) provision for regional haze in the State of Washington. This action identifies and corrects an error in that action by adding the factor to convert tons of sulfur dioxide (SO2) to pounds of SO2 that was inadvertently left out of the rule language for the FIP for the Alcoa Inc. Wenatchee Works.
Approval and Promulgation of Implementation Plans; State of Washington; Regional Haze State Implementation Plan; Federal Implementation Plan for Best Available Retrofit Technology for Alcoa Intalco Operations, Tesoro Refining and Marketing, and Alcoa Wenatchee
On June 11, 2014, the Environmental Protection Agency (EPA) published a final rule in the Federal Register concerning, in part, promulgation of a Federal Implementation Plan (FIP) provision for regional haze in the State of Washington. This action identifies and corrects an error in that action by adding the factor to convert from tons of sulfur dioxide (SO2) to pounds of SO2 that was inadvertently left out of the amendatory instructions for the FIP for the Alcoa Wenatchee Works.
Right-of-Way and Real Estate
The FHWA is proposing to amend its regulations governing the acquisition, management, and disposal of real property for transportation programs and projects receiving funds under title 23, United States Code. The revisions are prompted by enactment of the Moving Ahead for Progress in the 21st Century Act (MAP-21). Section 1302 of MAP-21 includes new early acquisition flexibilities that can be used by State departments of transportation (SDOT) and other grantees of title 23 Federal-aid highway program funds. This proposal is intended to develop regulations on the use of those new early acquisition flexibilities. The FHWA is also proposing to update the real estate regulations to reflect the agency's experience with the Federal-aid highway program since the last comprehensive rulemaking, which occurred more than a decade ago. The updates include clarifying the Federal-State partnership, streamlining processes to better meet current Federal-aid highway program needs, and eliminating duplicative and outdated regulatory language. This notice of proposed rulemaking provides interested parties with the opportunity to comment on proposed changes to the regulations.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
