October 12, 2017 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 154
Prospective Grant of Exclusive Patent License: DNA-Based Vaccine for Prevention of Zika Virus Infection
The National Institute of Allergy and Infectious Diseases (NIAID), an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Commercialization Patent License to PaxVax, Inc., located in Redwood City, California, to practice the inventions embodied in the patent applications listed in the Supplementary Information section of this notice.
SES Performance Review Board
Notice is hereby given of the appointment of members of the National Transportation Safety Board, Performance Review Board (PRB).
Export Trade Certificate of Review
The U.S. Department of Commerce issued an amended Export Trade Certificate of Review to CPEC on October 5, 2017.
Agency Information Collection Request; 60-Day Public Comment Request
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Medical Devices; Neurological Devices; Classification of Cranial Motion Measurement Device; Correction
The Food and Drug Administration (FDA) is correcting a final order entitled ``Medical Devices; Neurological Devices; Classification of Cranial Motion Measurement Device'' that appeared in the Federal Register of July 28, 2017. The final order was published with an incorrect statement in the preamble about whether FDA planned to exempt the device from premarket notification requirements. This document corrects that error.
Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards; Public Meeting; Request for Comments
The Food and Drug Administration (FDA or Agency) is announcing the following public meeting entitled ``Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards.'' The topics to be discussed will include the current status of electronic submissions and data standards initiatives to improve the predictability and consistency of the electronic submissions process in support of the human drug review program. FDA is seeking input from a variety of stakeholdersindustry, academia, patient advocates, professional societies and other interested partiesas it fulfills its commitment under the Prescription Drug User Fee Act of 2017 (PDUFA) to hold annual public meetings to seek stakeholder input related to enhancing the transparency and accountability of the electronic submission and data standards activities. FDA will use the information from the public meeting to inform the development of the FDA Information Technology (FDA IT) Strategic Plan and electronic submissions gateway target timeframes.
Certificate of Alternative Compliance for Hatteras CABO LLC's Fishing Yacht RESILIANT, HIN: HATHP606H718
The Coast Guard announces that the District Five Prevention Division has issued a Certificate of Alternate Compliance from the International Regulations for Preventing Collisions at Sea, 1972 (72 COLREGS), for Hatteras CABO LLC's fishing yacht RESILIANT, HIN: HATHP606H718 as required by statue. Due to the construction and placement of the pilothouse aft of amidships, the vessel cannot fully comply with the masthead light and sidelight provisions of the 72 COLREGS without interfering with the vessel's design and construction, as there are no structures forward of amidships on which a masthead light or sidelights could be affixed. This notice promotes the Coast Guard's maritime safety and stewardship missions.
Foreign Endangered and Threatened Species; Receipt of Applications for Permit
We, the U.S. Fish and Wildlife Service, invite the public to comment on the following applications to conduct certain activities with endangered and threatened species. With some exceptions, the Endangered Species Act prohibits activities with listed species unless Federal authorization is acquired that allows such activities.
Multistakeholder Process on Internet of Things Security Upgradability and Patching
The National Telecommunications and Information Administration (NTIA) will convene a virtual meeting of a multistakeholder process on Internet of Things Security Upgradability and Patching on November 8, 2017. This is the sixth in a series of meetings. For information on prior meetings, see Web site address below.
General Policies
This document contains proposed rules that would codify in the regulations and strengthen the Susquehanna River Basin Commission's (Commission) Access to Records Policy providing rules and procedures for the public to request and receive the Commission's public records.
Fisheries of the Exclusive Economic Zone Off Alaska; Inseason Adjustment to the 2017 Gulf of Alaska Pollock Seasonal Apportionments
NMFS is adjusting the 2017 D seasonal apportionments of the total allowable catch (TAC) for pollock in the Gulf of Alaska (GOA) by re-apportioning unharvested pollock TAC in Statistical Areas 610, 620, and 630 of the GOA. This action is necessary to provide opportunity for harvest of the 2017 pollock TAC, consistent with the goals and objectives of the Fishery Management Plan for Groundfish of the Gulf of Alaska.
Applied Sciences Advisory Committee; Meeting
In accordance with the Federal Advisory Committee Act, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Applied Sciences Advisory Committee (ASAC). This Committee functions in an advisory capacity to the Director, Earth Science Division, in the NASA Science Mission Directorate. The meeting will be held for the purpose of soliciting, from the applied sciences community and other persons, scientific and technical information relevant to program planning.
Agency Information Collection Activities; Proposed eCollection eComments Requested Revision of a Currently Approved Collection; Final Disposition Report (R-84), With Supplemental Questions R-84(a), R-84(b), R-84(c), R-84(d), R-84(e), R-84(f), R-84(g), R-84(h), R-84(i), and R-84(j)
The Department of Justice (DOJ), Federal Bureau of Investigation (FBI), Criminal Justice Information Services (CJIS) Division 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. The proposed information collection was previously published in the Federal Register on Month xx, 2017, allowing for a 60 day comment period.
Agency Information Collection Activities; Proposed eCollection, eComments Requested; Extension Without Change of a Previously Approved Collection; ARCOS Transaction Reporting, DEA Form 333
The Department of Justice (DOJ), Drug Enforcement Administration (DEA), 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. The proposed information collection was previously published in the Federal Register, on August 11, 2017, allowing for a 60 day comment period.
New Postal Products
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Air Plan Approval; Alabama; Regional Haze Plan and Prong 4 (Visibility) for the 2012 PM2.5
The Environmental Protection Agency (EPA) is taking the following four actions regarding the Alabama State Implementation Plan (SIP): Approving the portion of Alabama's October 26, 2015, SIP submittal seeking to change reliance from the Clean Air Interstate Rule (CAIR) to the Cross-State Air Pollution Rule (CSAPR) for certain regional haze requirements; converting EPA's limited approval/limited disapproval of Alabama's July 15, 2008, regional haze SIP to a full approval; approving the visibility prong of Alabama's infrastructure SIP submittals for the 2012 Fine Particulate Matter (PM2.5), 2010 Nitrogen Dioxide (NO2), and 2010 Sulfur Dioxide (SO2) National Ambient Air Quality Standards (NAAQS); and converting EPA's disapproval of the visibility portion of Alabama's infrastructure SIP submittal for the 2008 Ozone NAAQS to an approval.
Approval and Promulgation of Air Quality Implementation Plans; Colorado; Revisions to Regulation Number 3
The Environmental Protection Agency (EPA) is taking final action to approve a portion of the State Implementation Plan (SIP) revisions submitted by the State of Colorado on February 25, 2015. The revisions are to Colorado Air Quality Control Commission (Commission) Regulation Number 3, Parts A, B and D. The amendments the EPA is taking final action on include: Revisions to provisions for permitting emissions for particulate matter less than 2.5 micrograms (PM2.5) in Part D, modifications to the provisions for filing revised Air Pollution Emission Notices (APEN) in Part A and updates to public notice publication requirements in Part B. This action is being taken under section 110 of the Clean Air Act (CAA).
Approval and Promulgation of Air Quality Implementation Plans; State of South Carolina; Regional Haze State Implementation Plan
The Environmental Protection Agency (EPA) is approving a South Carolina State Implementation Plan (SIP) revision, submitted by the State of South Carolina through the South Carolina Department of Health and Environmental Control (SC DHEC) on December 28, 2012. South Carolina's December 28, 2012, SIP revision (``Progress Report'') addresses requirements of the Clean Air Act (CAA or ``Act'') and EPA's rules that require states to submit periodic reports describing progress towards reasonable progress goals (RPGs) established for regional haze and a determination of the adequacy of the State's existing SIP addressing regional haze (``regional haze plan''). EPA is finalizing approval of South Carolina's Progress Report on the basis that it addresses the progress report and adequacy determination requirements for the first implementation period for regional haze.
Air Plan Approval; KY; Miscellaneous Source Specific Revisions for Jefferson County
The Environmental Protection Agency (EPA) is taking final action to approve revisions to the Kentucky State Implementation Plan (SIP), submitted by the Commonwealth of Kentucky, through the Kentucky Division for Air Quality (KDAQ), on March 21, 2011, October 29, 2013, October 28, 2016, and March 24, 2017. The revisions were submitted by KDAQ on behalf of the Louisville Metro Air Pollution Control District, which has jurisdiction over Jefferson County, Kentucky. The revisions include changes to Jefferson County Regulations regarding Reasonably Available Control Technology (RACT) for two major sources of nitrogen oxides (NOx) and the removal of a volatile organic compounds (VOC) bubble rule.
Air Plan Approval; Alabama: PSD Replacement Units
Due to the receipt of adverse comments, the Environmental Protection Agency (EPA) is withdrawing the August 24, 2017, direct final rule that approves an Alabama state implementation plan (SIP) revision related to the Prevention of Significant Deterioration (PSD) permitting regulations. EPA will address the comments in a subsequent final action based upon the proposed rulemaking action, also published on August 24, 2017. EPA will not institute a second comment period on this action.
Recommendation for the Western Area Power Administration Loveland Area Projects and Colorado River Storage Project To Pursue Final Negotiations Regarding Membership in a Regional Transmission Organization
Western Area Power Administration (WAPA), a power marketing administration (PMA) of the Department of Energy (DOE), is publishing this recommendation for the Loveland Area Projects (LAP) and the Colorado River Storage Project (CRSP) to pursue final negotiations regarding membership in the Southwest Power Pool (SPP), a Regional Transmission Organization (RTO). WAPA is seeking public comment from its customers, Native American Tribes, stakeholders, and the public on the substance of WAPA's recommendation to pursue final negotiations regarding LAP and CRSP membership in SPP.
Proposed Olmsted Project Rate Order No. WAPA-177
The United States Department of Energy, Western Area Power Administration (WAPA), Colorado River Storage Project Management Center (CRSP MC), is proposing a new power formula rate for the Olmsted Hydroelectric Powerplant Replacement Project (Olmsted). There is no existing rate for Olmsted; therefore, the CRSP MC is proposing a new formula, under Rate Schedule Olmsted F-1, that will be used to determine the annual energy charge. WAPA will provide a brochure detailing information about the proposed formula rate prior to the public information forum and will post it to the Olmsted rate action Web site at https://www.wapa.gov/regions/CRSP/rates/Pages/rate-order- 177.aspx. If approved, the proposed formula rate under Rate Schedule Olmsted F-1 would become effective on April 1, 2018, and remain in effect through March 31, 2023, or until superseded. Publication of this Federal Register notice begins the formal process for the proposed formula rate.
Air Plan Approval; Kentucky; Regional Haze Progress Report
The Environmental Protection Agency (EPA) is finalizing approval of a State Implementation Plan (SIP) revision submitted by the Commonwealth of Kentucky through the Kentucky Energy and Environment Cabinet, Division of Air Quality (KDAQ) on September 17, 2014. Kentucky's September 17, 2014, SIP revision (Progress Report) addresses requirements of the Clean Air Act (CAA or Act) and EPA's rules that require each state to submit periodic reports describing progress towards reasonable progress goals (RPGs) established for regional haze and a determination of the adequacy of the state's existing SIP addressing regional haze (regional haze plan). EPA is finalizing approval of Kentucky's determination that the Commonwealth's regional haze plan is adequate to meet these RPGs for the first implementation period covering through 2018 and requires no substantive revision at this time.
Air Plan Approval: Alabama; Transportation Conformity
Due to the receipt of an adverse comment, the Environmental Protection Agency (EPA) is withdrawing the August 17, 2017, direct final rule that approves an Alabama state implementation plan (SIP) revision related to transportation conformity requirements. EPA will address the comment in a subsequent final action based upon the proposed rulemaking action, also published on August 17, 2017. EPA will not institute a second comment period on this action.
Air Plan Approval: Alabama; Transportation Conformity
The Environmental Protection Agency (EPA) is approving a portion of a revision to the Alabama State Implementation plan (SIP) submitted by the State of Alabama on May 8, 2013, for the purpose of amending the transportation conformity rules to be consistent with Federal requirements.
Air Plan Approval; Iowa; Amendment to the Administrative Consent Order, Grain Processing Corporation, Muscatine, Iowa; Withdrawal of Direct Final Rule
Due to an adverse comment, the Environmental Protection Agency (EPA) is withdrawing the direct final rule for ``Air Plan Approval; Iowa; Amendment to the Administrative Consent Order, Grain Processing Corporation, Muscatine, Iowa,'' published in the Federal Register on August 25, 2017.
DOE/NSF Nuclear Science Advisory Committee
Pursuant to Section 14(a)(2)(A) of the Federal Advisory Committee Act, as amended, and following consultation with the Committee Management Secretariat, General Services Administration, notice is hereby given that the DOE/NSF Nuclear Science Advisory Committee (NSAC) has been renewed for a two-year period. The Committee will provide advice and recommendations to the Director, Office of Science (DOE), and the Assistant Director, Directorate for Mathematical and Physical Sciences (NSF), on scientific priorities within the field of basic nuclear science research. Additionally, the renewal of the NSAC has been determined to be essential to conduct business of the Department of Energy and the National Science Foundation, and to be in the public interest in connection with the performance of duties imposed upon DOE and NSF, by law and agreement. The Committee will continue to operate in accordance with the provisions of the Federal Advisory Committee Act, adhering to rules and regulations issued implementation of that Act.
Civil Monetary Penalty Catch Up Inflation Adjustment and Annual Inflation Adjustment
This Interim Final Rule adjusts for inflation the maximum civil penalty that the NTSB may assess against a person for violating certain NTSB statutes and regulations.
List of Fisheries for 2018
The National Marine Fisheries Service (NMFS) publishes its proposed List of Fisheries (LOF) for 2018, as required by the Marine Mammal Protection Act (MMPA). The LOF for 2018 reflects new information on interactions between commercial fisheries and marine mammals. NMFS must classify each commercial fishery on the LOF into one of three categories under the MMPA based upon the level of mortality and serious injury of marine mammals that occurs incidental to each fishery. The classification of a fishery on the LOF determines whether participants in that fishery are subject to certain provisions of the MMPA, such as registration, observer coverage, and take reduction plan (TRP) requirements.
Group Registration of Unpublished Works
The U.S. Copyright Office is proposing to create a new group registration option for a limited number of unpublished works. To qualify for this group option, all the works must be created by the same author or the same joint authors, and the author or joint authors must be named as the copyright claimant for each work. The claim to copyright in each work must be the same, and each work must be registered in the same administrative class. In general, applicants will be allowed to include up to five works in each submission. Applicants will be required to submit an online application and upload their works to the electronic registration system, although the Office may waive these requirements in exceptional cases. This new group registration option will replace the current ``unpublished collections'' option, which the Office has determined is an ineffective mechanism for registration of multiple unpublished works; among other things, it allows applicants to register an essentially unlimited number of works. The proposed rule will allow the Office to more easily examine each work for copyrightable authorship, create a more robust record of the claim, and improve the efficiency of the registration process. The Proposed Rule also makes unrelated technical amendments to the ``unit of publication'' regulation.
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