Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops.'' This draft guidance provides FDA's interpretation of, and a compliance policy for, the requirement that the label of tobacco products contain an accurate statement of the percentage of foreign and domestic grown tobacco under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This draft guidance document is also intended to assist retailers who sell newly deemed products by explaining whether engaging in certain activities subjects such establishments to additional requirements of the FD&C Act and the limited circumstances under which FDA does not intend to enforce compliance.
Notice of Determinations; Culturally Significant Objects Imported for Exhibition Determinations: “Enlightened Princesses: Caroline, Augusta, Charlotte, and the Shaping of the Modern World” Exhibition
Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), E.O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, et seq.; 22 U.S.C. 6501 note, et seq.), Delegation of Authority No. 234 of October 1, 1999, Delegation of Authority No. 236-3 of August 28, 2000 (and, as appropriate, Delegation of Authority No. 257 of April 15, 2003), I hereby determine that the objects to be included in the exhibition ``Enlightened Princesses: Caroline, Augusta, Charlotte, and the Shaping of the Modern World,'' imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at the Yale Center for British Art, New Haven, Connecticut, from on or about February 2, 2017, until on or about April 30, 2017, and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these Determinations be published in the Federal Register.
Agenda and Notice of Public Meeting of the Delaware Advisory Committee; Correction
The Commission on Civil Rights published a notice in the Federal Register of September 15, 2016, concerning a meeting of the Delaware Advisory Committee. The meeting time for the January 18, 2017 is changed.
Sanctions Actions Pursuant to Executive Order 13224
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of 4 individuals whose property and interests in property are blocked pursuant to Executive Order 13224 of September 23, 2001, ``Blocking Property and Prohibiting Transactions With Persons Who Commit, Threaten To Commit, or Support Terrorism.''
Visiting Committee on Advanced Technology
The National Institute of Standards and Technology (NIST) originally published a document announcing an upcoming meeting of the Visiting Committee on Advanced Technology (VCAT or Committee) on January 3, 2017 (82 FR 92). The meeting time, dates, and details have been updated. The VCAT will now meet by webinar in an open session on Wednesday, February 8, 2017 from 1:30 p.m. to 4:30 p.m. Eastern Time. The VCAT is composed of fifteen members appointed by the NIST Director who are eminent in such fields as business, research, new product development, engineering, labor, education, management consulting, environment, and international relations.
Endangered 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 species. With some exceptions, the Endangered Species Act (ESA) prohibit activities with listed species unless Federal authorization is acquired that allows such activities.
Public Notice for Waiver of Aeronautical Land-Use Assurance
The FAA is considering a proposal to change 0.189 acres of airport land from aeronautical use to non-aeronautical use and to authorize the sale of airport property located at 5321 South Menard Avenue, Chicago, Illinois. The land is located off airport in a residential zoned area in Chicago, IL. This land is to be sold at Fair Market Value (FMV) to a locally-based business to be used as a parking lot. The land was purchased with federal funds under the Federal Aid to Airports Program (FAAP) and currently not used for aeronautical purposes. FAR Part 77, Right of Flight, and other compatible aeronautical land-uses would continue to be protected with deed restrictions required in the transfer of land ownership. The property is no longer needed for aeronautical use.
Notice of Determinations; Culturally Significant Objects Imported for Exhibition Determinations: “Alexei Jawlensky” Exhibition
Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), E.O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, et seq.; 22 U.S.C. 6501 note, et seq.), Delegation of Authority No. 234 of October 1, 1999, Delegation of Authority No. 236-3 of August 28, 2000 (and, as appropriate, Delegation of Authority No. 257 of April 15, 2003), I hereby determine that the objects to be included in the exhibition ``Alexei Jawlensky,'' imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at the Neue Galerie, New York, New York, from on or about February 16, 2017, until on or about May 29, 2017, and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these Determinations be published in the Federal Register.
Use of Lead Free Pipes, Fittings, Fixtures, Solder and Flux for Drinking Water
The Environmental Protection Agency (EPA) proposes to make conforming changes to existing drinking water regulations based on the Reduction of Lead in Drinking Water Act of 2011 (RLDWA) and the Community Fire Safety Act of 2013 (CFSA). Section 1417 of the Safe Drinking Water Act (SDWA) prohibits the use and introduction into commerce of certain plumbing products that are not lead free. The RLDWA revised the definition of lead free to lower the allowable maximum lead content from 8.0 percent to a weighted average of 0.25 percent of the wetted surfaces of plumbing products and established a statutory method for calculating lead content. In addition, the RLDWA created exemptions from the lead free requirements for plumbing products that are used exclusively for nonpotable services as well as for other specified products. The CFSA further amended section 1417 to exempt fire hydrants from these requirements. EPA proposes to establish new requirements to assure that individuals purchasing, installing or inspecting potable water systems can identify lead free plumbing materials. Specifically, EPA proposes to establish labeling requirements to differentiate plumbing products that meet the lead free requirements from those that are exempt from the lead free requirements and to require manufacturers to certify compliance with the lead free requirements. These proposed requirements would reduce inadvertent use of non-lead free plumbing products in potable use applications and, consequently, reduce exposure to lead in drinking water and associated adverse health effects.
Juvenile Justice and Delinquency Prevention Act Formula Grant Program
The Office of Juvenile Justice and Delinquency Prevention (``OJJDP'') of the U.S. Department of Justice's Office of Justice Programs (``OJP''), publishes this partial final rule to amend portions of the formula grant program (``Formula Grant Program'') regulation to reflect changes in OJJDP policy.
Waiver of Requirements for the State of New York: CDBG Disaster Recovery Grants for Recovery of Lower Manhattan
This notice advises the public of an additional waiver applicable to the Community Development Block Grant Disaster Recovery (CDBG-DR) grants provided to the State of New York for the purpose of assisting in the recovery from the September 11, 2001, terrorist attacks on New York City. As described in the ``Background'' section of this notice, HUD is authorized by statute and regulations to waive statutory and regulatory requirements and specify alternative requirements for this purpose upon the request of the grantee.
Civil Monetary Penalties-2017 Adjustment
The Surface Transportation Board (Board) is issuing a final rule to implement the annual inflationary adjustment to its civil monetary penalties, pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015.
Importation of Hass Avocados From Colombia
We are reopening the comment period for a proposed rule to allow the importation of Hass avocados from Colombia into the continental United States. We are also notifying the public of the availability of a revised pest risk assessment and risk management document associated with the proposed rule. This action will allow interested persons additional time to prepare and submit comments.
Donations of Technology and Support Services To Enforce Intellectual Property Rights
This document proposes amendments to the U.S. Customs and Border Protection (CBP) regulations pertaining to the enforcement of intellectual property rights. Specifically, CBP is proposing amendments to implement a section of the Trade Facilitation and Trade Enforcement Act of 2015 which requires CBP to prescribe regulatory procedures for the donation of technologies, training, or other support services for the purpose of assisting CBP in intellectual property enforcement. The proposed regulations would enhance CBP's intellectual property rights enforcement capabilities.
International Entrepreneur Rule
This final rule amends Department of Homeland Security (DHS) regulations to implement the Secretary of Homeland Security's discretionary parole authority in order to increase and enhance entrepreneurship, innovation, and job creation in the United States. The final rule adds new regulatory provisions guiding the use of parole on a case-by-case basis with respect to entrepreneurs of start-up entities who can demonstrate through evidence of substantial and demonstrated potential for rapid business growth and job creation that they would provide a significant public benefit to the United States. Such potential would be indicated by, among other things, the receipt of significant capital investment from U.S. investors with established records of successful investments, or obtaining significant awards or grants from certain Federal, State or local government entities. If granted, parole would provide a temporary initial stay of up to 30 months (which may be extended by up to an additional 30 months) to facilitate the applicant's ability to oversee and grow his or her start-up entity in the United States.
Security Zones; Annual Events in the Captain of the Port Detroit Zone-North American International Auto Show, Detroit River, Detroit MI
The Coast Guard will enforce a security zone associated with the North American International Auto Show, Detroit River, Detroit, MI. This security zone is intended to restrict vessels from a portion of the Detroit River in order to ensure the safety and security of participants, visitors, and public officials at the North American International Auto Show (NAIAS), which is being held at Cobo Hall in downtown Detroit, MI. Vessels in close proximity to the security zone will be subject to increased monitoring and boarding during the enforcement of the security zone. No person or vessel may enter the security zone while it is being enforced without permission of the Captain of the Port Detroit.
Proposed Amendment of Class E Airspace, Atlantic City, NJ
This action proposes to amend Class E airspace at Atlantic City, NJ, as Atlantic City Municipal/Bader Field has closed, requiring airspace reconfiguration at Atlantic City International Airport. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations Atlantic City International Airport.
Repayment by VA of Educational Loans for Certain Psychiatrists; Correction
The Department of Veterans Affairs published in the Federal Register on September 29, 2016, a document amending its regulations concerning the repayment of educational loans for certain psychiatrists who agree to a period of obligated service with VA. The document contained several section and paragraph numbering errors. This document corrects the errors and does not make any substantive change to the content of the final rule.
Airworthiness Directives; The Boeing Company Airplanes
We are adopting a new airworthiness directive (AD) for certain The Boeing Company Model 767-300 and 767-300F series airplanes. This AD was prompted by reports of malfunctions in the flight deck display units, which resulted in blanking, blurring, or loss of color on the display. This AD requires modification and installation of components in the main equipment center. For certain other airplanes this AD requires modification, replacement, and installation of flight deck air relief system (FDARS) components. We are issuing this AD to address the unsafe condition on these products.
Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act
As required under section 6(b)(1) of the Toxic Substances Control Act (TSCA), EPA is proposing to establish a risk-based screening process and criteria that EPA will use to identify chemical substances as either High-Priority Substances for risk evaluation, or Low-Priority Substances for which risk evaluations are not warranted at the time. The proposed rule describes the processes for identifying potential candidates for prioritization, selecting a candidate, screening that candidate against certain criteria, formally initiating the prioritization process, providing opportunities for public comment, and proposing and finalizing designations of priority. Prioritization is the initial step in a new process of existing chemical substance review and risk management activity established under recent amendments to TSCA.
Medicare Program: Changes to the Medicare Claims and Entitlement, Medicare Advantage Organization Determination, and Medicare Prescription Drug Coverage Determination Appeals Procedures
This final rule revises the procedures that the Department of Health and Human Services (HHS) follows at the Administrative Law Judge (ALJ) level for appeals of payment and coverage determinations for items and services furnished to Medicare beneficiaries, enrollees in Medicare Advantage (MA) and other Medicare competitive health plans, and enrollees in Medicare prescription drug plans, as well as appeals of Medicare beneficiary enrollment and entitlement determinations, and certain Medicare premium appeals. In addition, this final rule revises procedures that the Department of Health and Human Services follows at the Centers for Medicare & Medicaid Services (CMS) and the Medicare Appeals Council (Council) levels of appeal for certain matters affecting the ALJ level.
Airworthiness Directives; Airbus Airplanes
We are adopting a new airworthiness directive (AD) for certain Airbus Model A319-115, A319-132, A320-214, A320-232, A321-211, A321- 213, and A321-231 airplanes. This AD was prompted by a report of certain tie rod assemblies installed on the hinged fairing assembly of the main landing gear (MLG) with no cadmium plating on the rod end threads. This AD requires inspection and replacement of certain tie rod assemblies installed on the hinged fairing assembly of the MLG. We are issuing this AD to address the unsafe condition on these products.
Airworthiness Directives; The Boeing Company Airplanes
We are adopting a new airworthiness directive (AD) for certain The Boeing Company Model 787-8 and 787-9 airplanes. This AD was prompted by a report that some inboard and outboard trailing edge flap rotary actuators may have been assembled with an incorrect no-back brake rotor-stator stack sequence during manufacturing. This AD requires inspecting the trailing edge flap rotary actuator, and replacing the rotary actuator or doing related investigative and corrective actions if necessary. We are issuing this AD to address the unsafe condition on these products.
Extension of the Designation of Somalia for Temporary Protected Status
The Department of Homeland Security (DHS) announces that the Secretary of Homeland Security (Secretary) is extending the designation of Somalia for Temporary Protected Status (TPS) for a period of 18 months, effective March 18, 2017 through September 17, 2018. This extension allows eligible Somali nationals (and aliens having no nationality who last habitually resided in Somalia) to retain TPS through September 17, 2018, so long as they otherwise continue to meet the eligibility requirements for TPS. The Secretary has determined that an extension is warranted because conditions in Somalia supporting its designation for TPS continue to be met. Through this Notice, DHS also sets forth procedures necessary for nationals of Somalia (or aliens having no nationality who last habitually resided in Somalia) to re- register for TPS and to apply for renewal of their Employment Authorization Documents (EAD) with U.S. Citizenship and Immigration Services (USCIS).
Revisions to the Guideline on Air Quality Models: Enhancements to the AERMOD Dispersion Modeling System and Incorporation of Approaches To Address Ozone and Fine Particulate Matter
In this action, the Environmental Protection Agency (EPA) promulgates revisions to the Guideline on Air Quality Models (``Guideline''). The Guideline provides EPA's preferred models and other recommended techniques, as well as guidance for their use in estimating ambient concentrations of air pollutants. It is incorporated into the EPA's regulations, satisfying a requirement under the Clean Air Act (CAA) for the EPA to specify with reasonable particularity models to be used in the Prevention of Significant Deterioration (PSD) program. This action includes enhancements to the formulation and application of the EPA's preferred near-field dispersion modeling system, AERMOD (American Meteorological Society (AMS)/EPA Regulatory Model), and the incorporation of a tiered demonstration approach to address the secondary chemical formation of ozone and fine particulate matter (PM2.5) associated with precursor emissions from single sources. The EPA is changing the preferred status of and removing several air quality models from appendix A of the Guideline. The EPA is also making various editorial changes to update and reorganize information throughout the Guideline to streamline the compliance assessment process.
Unified Registration System; Suspension of Effectiveness
The FMCSA suspends its regulations requiring existing interstate motor carriers, freight forwarders, brokers, intermodal equipment providers (IEPs), hazardous materials safety permit (HMSP) applicants, and cargo tank facilities under FMCSA jurisdiction to submit required registration and biennial update information to the Agency via a new electronic on-line Unified Registration System (URS). During this suspension, entities needing to file will follow the same procedures and forms used to submit information to FMCSA as they do today.
Revisions to National Emission Standards for Radon Emissions From Operating Mill Tailings
The Environmental Protection Agency (EPA) is taking final action to revise certain portions of the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Radon Emissions from Operating Mill Tailings. The revisions for this final action are based on the EPA's determination as to what constitutes generally available control technology or management practices (GACT) for this area source category. We are also adding new definitions to the NESHAP, revising existing definitions and clarifying that the NESHAP also applies to uranium recovery facilities that extract uranium through the in-situ leach method and the heap leach method.
Notice of Availability of the Record of Decision for the Dominguez-Escalante National Conservation Area Resource Management Plan and Final Environmental Impact Statement, Colorado
The Bureau of Land Management (BLM) announces the availability of the Record of Decision (ROD) for the Approved Resource Management Plan (RMP) and Final Environmental Impact Statement for the Dominguez- Escalante National Conservation Area (NCA) located in Mesa, Delta and Montrose counties, Colorado. The Colorado State Director signed the ROD on January 9, 2017, which constitutes the final decision of the BLM and makes the Approved RMP effective immediately.
Notice of Temporary Closures and Restrictions of Public Lands in La Paz County, AZ
Notice is hereby given that closures and restrictions will be in effect on public lands administered by the Bureau of Land Management (BLM), Lake Havasu Field Office. This action is being taken to protect public safety and resources within and adjacent to the permitted operations of the Best in the Desert (BITD) Racing Association ``GMZ Utility Terrain Vehicle Winter Nationals Parker 250'' and ``BlueWater Resort Parker 425'' off-highway vehicle (OHV) events.
Public Land Order No. 7859; Withdrawal of National Forest System and Bureau of Land Management Public Lands in Southwestern Oregon; Oregon
This order withdraws, subject to valid existing rights, approximately 5,216.18 acres of public domain and Revested Oregon and California Railroad lands and 95,805.53 acres of National Forest System lands from settlement, sale, location, and entry under the public land laws; location and entry under the United States mining laws; and operation of the mineral and geothermal leasing laws for a period of 20 years while Congress considers legislation to permanently withdraw those areas and to protect the Southwestern Oregon watershed from possible adverse effects of mineral development.
Action Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)
The National Institutes of Health (NIH) considered a proposal to conduct research involving the deliberate transfer of a chloramphenicol resistance trait to Rickettsia typhi, conorii, rickettsii, and felis. The acquisition of this antibiotic resistance trait could possibly compromise the use of a class of antibiotics for the treatment of Rickettsia infections in humans. Under the NIH Guidelines (http://www.osp.od.nih.gov/sites/default/files/ NIH_Guidelines.html), these experiments can proceed only after they are reviewed by the NIH Recombinant DNA Advisory Committee (RAC) and specifically approved by the NIH Director as Major Actions. This proposal was discussed at the December 4, 2015, RAC meeting. The proposal was published in the Federal Register on December 29, 2015, (80 FR 81346) with a request for public comment; one comment was received. This notice announces the final NIH action regarding this proposal.
National Emission Standards for Hazardous Air Pollutants: Nutritional Yeast Manufacturing Risk and Technology Review
On December 28, 2016, the Environmental Protection Agency (EPA) published a notice to announce its proposed amendments to the National Emission Standards for Hazardous Air Pollutants for the Manufacturing of Nutritional Yeast source category. The notice also requested public comment on the proposed amendments. The EPA is announcing that a public hearing will be held. In addition, the EPA is extending the public comment period.
Renewal of Approved Information Collection; OMB Control No. 1004-0196
In compliance with the Paperwork Reduction Act, the Bureau of Land Management (BLM) invites public comments on, and plans to request approval to continue, the collection of information from participants in the oil and gas leasing program within the National Petroleum ReserveAlaska (NPRA). The Office of Management and Budget (OMB) has assigned control number 1004-0196 to this information collection.
Renewal of Approved Information Collection; OMB Control No. 1004-0042
The Bureau of Land Management (BLM) has submitted an information collection request to the Office of Management and Budget (OMB) to continue the collection of information from those who wish to adopt and obtain title to wild horses and burros. The OMB previously approved this information collection activity, and assigned it control number 1004-0042.
Notice of Intent to Grant Exclusive License
Notice is hereby given that the U.S. Department of Agriculture, Agricultural Research Service, intends to grant to Huvepharma, Inc. of Peachtree City, Georgia, an exclusive license to U.S. Patent Application Serial No. 15/108,725, ``MUTATED SALMONELLA ENTERIACA'', filed on June 28, 2016.