2017 – Federal Register Recent Federal Regulation Documents
Results 5,051 - 5,100 of 27,453
Proposed Information Collection; Comment Request; West Coast Region U.S. Pacific Highly Migratory Species Hook and Line Logbook
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.
National Emission Standards for Hazardous Air Pollutants for Wool Fiberglass Manufacturing; Flame Attenuation Lines
Because the Environmental Protection Agency (EPA) received adverse comment, we are withdrawing the direct final rule for the National Emission Standards for Hazardous Air Pollutants for Wool Fiberglass Manufacturing; Flame Attenuation Lines, published on July 27, 2017.
Drawbridge Operation Regulation; Reynolds Channel, Lawrence, NY
The Coast Guard is modifying the operating schedule that governs the Atlantic Beach Bridge across Reynolds Channel, mile 0.4 at Lawrence, New York. This action is necessary to allow for an unexpected delay in the reconstruction and painting of the bascule leaves. A temporary deviation was previously granted for a length of 180 days. As the Coast Guard may not approve extensions beyond that allotted timeframe nor approve back-to-back or sequential deviations, it is necessary to issue this rule in order to allow the bridge owner to complete the remaining work items.
Drawbridge Operation Regulation; Isthmus Slough, Coos Bay, OR
The Coast Guard proposes to change the operating schedule that governs the Oregon State secondary highway bridge (Isthmus Slough Bridge), across Isthmus Slough, mile 1.0, at Coos Bay, OR. To accommodate Oregon Department of Transportation's (ODOT) preservation, painting and replacement of the bridge equipment, the Coast Guard proposes to operate half the double bascule span (single leaf). Additionally, during the period of this work, the non-functioning leaf of the span's vertical clearance will be reduced.
Commerce Spectrum Management Advisory Committee Meeting
This notice announces a public meeting of the Commerce Spectrum Management Advisory Committee (Committee). The Committee provides advice to the Assistant Secretary of Commerce for Communications and Information and the National Telecommunications and Information Administration (NTIA) on spectrum management policy matters.
Regulated Navigation Area; Beals Island Bridge Replacement, Moosabec Reach, Jonesport, ME
The Coast Guard is establishing a temporary Regulated Navigation Area (RNA) for the navigable waters within 150-yards of the Beals Island Bridge between Jonesport, ME, and Beals Island, ME. The RNA is needed to protect personnel, vessels, and the marine environment from the potential hazards created by the demolition, subsequent removal, and replacement of the Beals Island Bridge. This RNA will establish speed and beam restrictions on vessels transiting the regulated area during bridge replacement operations. This rule will also allow the Coast Guard to prohibit vessel traffic through the RNA when necessary.
Notice of Public Meeting, North Slope Science Initiative-Science Technical Advisory Panel, Alaska
In accordance with the Federal Land Policy and Management Act of 1976, the Energy Policy Act of 2005, and the Federal Advisory Committee Act of 1972, the U.S. Department of the Interior, Bureau of Land Management North Slope Science InitiativeScience Technical Advisory Panel will meet as indicated below.
Watson Laboratories, Inc., and Barr Laboratories, Inc., Subsidiaries of Teva Pharmaceuticals USA, Inc.; Withdrawal of Approval of 54 Abbreviated New Drug Applications
The Food and Drug Administration (FDA) is withdrawing approval of 54 abbreviated new drug applications (ANDAs) from two applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Annual Business Survey
Notice is hereby given that the Bureau of the Census (Census Bureau) is considering a proposal to conduct an Annual Business Survey (ABS). Based on information and recommendations received by the Census Bureau, we understand that the data have significant application to the needs of other government agencies and the public. The ABS will provide the only comprehensive data on business owner demographics and business characteristics, including financing, research and development (for microbusinesses), and innovation. These data are not publicly available from nongovernment or other governmental sources.
Drafting a New Federal Strategy To Reduce Childhood Lead Exposures and Impacts: Request for Information
Through this notice, the U.S. Department of Housing and Urban Development (HUD), which co-chairs the Lead Subcommittee of the President's Task Force on Environmental Health Risks and Safety Risks to Children (Task Force) requests public comment on a new federal lead strategy being developed by the Task Force.
Agenda and Notice of Public Meeting of the Montana Advisory Committee
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a planning meeting of the Montana Advisory Committee to the Commission will convene at 11:00 a.m. (MDT) on Tuesday, October 24, 2017, via teleconference. The purpose of the meeting is continue to plan to hear testimony on border town discrimination issues in Montana.
New England Fishery Management Council; Public Meeting
The New England Fishery Management Council (Council) is scheduling a public meeting of its Recreational Advisory Panel to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.
Fisheries of the Gulf of Mexico; Southeast Data, Assessment, and Review (SEDAR); Public Meeting
The SEDAR 51 assessment process of Gulf of Mexico gray snapper will consist of a Data Workshop, a series of assessment webinars, and a Review Workshop.
Pacific Fishery Management Council; Public Meetings
The Pacific Fishery Management Council (Pacific Council) and its advisory entities will hold public meetings.
Mid-Atlantic Fishery Management Council (MAFMC); Public Meeting
The Mid-Atlantic Fishery Management Council's (MAFMC's) Summer Flounder, Scup, and Black Sea Bass Monitoring Committee will hold a public meeting.
Agency Information Collection Activity Under OMB Review: Requirements for Interest Rate Reduction Refinancing Loans
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Loan Guaranty Service, Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and it includes the actual data collection instrument.
Agency Information Collection Activity: Veterans Mortgage Life Insurance Inquiry
Veterans Benefits Administrations, Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of a currently approved collection, and allow 60 days for public comment in response to the notice. This notice solicits comments on information needed from Veterans for the proper maintenance of Veterans Mortgage Life Insurance accounts.
Agency Information Collection Activity: VA National Veterans Sports Programs and Special Events
Office of National Programs and Special Events (NVSP), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of a currently approved collection, and allow 60 days for public comment in response to the notice.
Electronic Study Data Submission; Data Standards; Support for Version Update of World Health Organization Drug Global
The Food and Drug Administration (FDA or Agency) is announcing support for the most current B3-format annual version of the World Health Organization (WHO) Drug Global (WHODG) (formerly named WHO Drug Dictionary) (available at https://www.who-umc.org), end of support for earlier versions of WHODG, and an update to the FDA Data Standards Catalog (Catalog) for study data provided in new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and certain investigational new drug applications (INDs) to the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER).
Pacific Island Pelagic Fisheries; 2017 U.S. Territorial Longline Bigeye Tuna Catch Limits for the Commonwealth of the Northern Mariana Islands
NMFS announces a valid specified fishing agreement that allocates up to 1,000 metric tons (t) of the 2017 bigeye tuna limit for the Commonwealth of the Northern Mariana Islands (CNMI) to identified U.S. longline fishing vessels. The agreement supports the long-term sustainability of fishery resources of the U.S. Pacific Islands, and fisheries development in the CNMI.
Submission for OMB Review; General Services Acquisition Regulation; Information Specific to a Contract or Contracting Action (Not Required by Regulation)
Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement regarding Information Specific to a Contract or Contracting Action (not required by regulation). A notice was published in the Federal Register at 82 FR 33911 on July 21, 2017. No comments were received.
Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Snapper-Grouper Fishery of the South Atlantic; Re-Opening of the Commercial Sector for Blueline Tilefish
NMFS announces the re-opening of the commercial sector for blueline tilefish in the exclusive economic zone (EEZ) of the South Atlantic through this temporary rule. The most recent commercial landings data for blueline tilefish indicate the commercial annual catch limit (ACL) for the 2017 fishing year has not yet been reached. Therefore, NMFS re-opens the commercial sector for blueline tilefish in the South Atlantic EEZ for 8 days to allow the commercial ACL to be caught, while minimizing the risk of the commercial ACL being exceeded.
Medical Devices; Immunology and Microbiology Devices; Classification of the Mass Spectrometer System for Clinical Use for the Identification of Microorganisms
The Food and Drug Administration (FDA or we) is classifying the mass spectrometer system for clinical use for the identification of microorganisms into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the mass spectrometer system for clinical use for the identification of microorganisms' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Welded Carbon Steel Standard Pipe and Tube Products From Turkey: Final Results of Antidumping Duty Administrative Review and Final Determination of No Shipments; 2015-2016
On June 6, 2017, the Department of Commerce (the Department) published the preliminary results of the administrative review of the antidumping duty order on welded carbon steel standard pipe and tube products (welded pipe and tube) from Turkey. The period of review (POR) is May 1, 2015 through April 30, 2016. The review covers the following producers/exporters of the subject merchandise: Borusan Istikbal Ticaret T.A.S. (Borusan Istikbal) and Borusan Mannesmann Boru Sanayi ve Ticaret A.S. (Borusan Mannesmann) (collectively, Borusan); Toscelik Profil ve Sac Endustrisi A.S., Tosyali Dis Ticaret A.S., and Toscelik Metal Ticaret A.S. (Toscelik Metal) (collectively, Toscelik); Borusan Birlesik Boru Fabrikalari San ve Tic (Borusan Birlesik); Borusan Gemlik Boru Tesisleri A.S. (Borusan Gemlik); Borusan Ihracat Ithalat ve Dagitim A.S. (Borusan Ihracat); Borusan Ithicat ve Dagitim A.S. (Borusan Ithicat); Tubeco Pipe and Steel Corporation (Tubeco); Erbosan Erciyas Boru Sanayi ve Ticaret A.S. (Erbosan); and Yucel Boru ve Profil Endustrisi A.S., Yucelboru Ihracat Ithalat ve Pazarlama A.S., and Cayirova Boru Sanayi ve Ticaret A.S. (collectively, the Yucel Group). Based on our analysis of the comments received, we have made certain changes in the margin calculations. The final weighted-average dumping margins for the reviewed firms are listed below in the section entitled, ``Final Results of the Review.'' Further, we continue to find that Erbosan, Borusan Birlesik, Borusan Gemlik, Borusan Ihracat, Borusan Ithicat, and Tubeco had no reviewable shipments of subject merchandise during the POR.
Trand Doan Nguyen; Denial of Hearing; Final Debarment Order
The Food and Drug Administration (FDA) is denying Trang Doan Nguyen's (Nguyen's) request for a hearing and is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Nguyen for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Nguyen was convicted of a misdemeanor under Federal law for conduct relating to the development or approval of a drug product or otherwise relating the regulation of a drug product under the FD&C Act and that the type of conduct underlying the conviction undermines the process for the regulation of drugs. In determining the appropriateness and period of Nguyen's debarment, FDA has considered the relevant factors listed in the FD&C Act. Nguyen has failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action.
Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery
As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, we are seeking comment on the development of the following proposed Generic Information Collection Request (Generic ICR): ``Fast Track Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' for approval under the Paperwork Reduction Act (PRA). This notice announces our intent to submit this collection to OMB for approval and solicits comments on specific aspects for the proposed information collection. This option is a fast track for approval to streamline the timing to implement certain types of surveys and related collection of information. USAID uses the approval to cover the instruments of collection (such as a survey, a window pop-up survey, a focus group, or a comment card), which are designed to get customer feedback on USAID service delivery for various programs. This request for approval broadly addresses USAID's need for information about what our customers think of our services so that we can improve service delivery; specific information collection activities will be incorporated into the approval as the need for the information is identified. For example, when we implement a new program and provide information about the services for the program on our Web site, we may provide a voluntary customer service questionnaire about how well the program is working for our customers, specifically within the area of customer service. USAID is requesting to increase the number of respondents in the fast track approval due to an anticipated increase in the number of customer respondents responding to customer service surveys that will be sent to a broader scope and greater number of USAID customers.
Fourchon LNG LLC; Application for Long-Term, Multi-Contract Authorization To Export Liquefied Natural Gas to Non-Free Trade Agreement Nations
The Office of Fossil Energy (FE) of the Department of Energy (DOE) gives notice of receipt of an application (Application), filed on August 17, 2017, by Fourchon LNG LLC (Fourchon LNG), requesting long- term, multi-contract authorization to export domestically produced liquefied natural gas (LNG) in a volume equivalent to 260 billion cubic feet (Bcf) per year. Fourchon LNG seeks authorization to export this LNG from a proposed natural gas liquefaction facility to be located on Port Fourchon at Belle Pass in Lafourche Parish, Louisiana (Facility). Fourchon LNG proposes to site, construct, own, and operate this Facility with a peak capacity of approximately five million tonnes per annum (mtpa). The Facility will be developed in phases, with the first phase expected to have a capacity of two mtpa, to be followed by the remaining LNG trains as demand develops, each of which will have a capacity of 0.5 mtpa. Fourchon LNG requests authorization to export this LNG to countries with which trade is not prohibited by U.S. law or policy, including both countries with which the United States has entered into a free trade agreement (FTA) requiring national treatment for trade in natural gas (FTA countries) and all other countries (non- FTA countries). Fourchon LNG requests the non-FTA authorization for a term of 20 years, to commence on the date of first export following the commencement of operations or seven years from the date of a final order granting export authorization, whichever is first. Fourchon LNG is requesting this authorization on its own behalf and as agent for other entities who hold title to the natural gas at the time of export. Fourchon LNG filed the Application under section 3 of the Natural Gas Act (NGA). Additional details can be found in Fourchon LNG's Application, posted on the DOE/FE Web site at https://www.energy.gov/ fe/downloads/fourchon-lng-llc-fe-dkt-no-17-105-lng. Protests, motions to intervene, notices of intervention, and written comments are invited.
Arts Advisory Panel Meetings
Pursuant to the Federal Advisory Committee Act, as amended, notice is hereby given that 22 meetings of the Arts Advisory Panel to the National Council on the Arts will be held by teleconference.
Airworthiness Directives; Airbus Airplanes
We propose to adopt a new airworthiness directive (AD) for all Airbus Model A318-111 and -112 airplanes; Model A319-111, -112, -113, - 114, and -115 airplanes; Model A320-211, -212, -214, and -216 airplanes; and Model A321-111, -112, -211, -212, and -213 airplanes. This proposed AD was prompted by a review of maintenance instructions for a blend repair of the snout diameter of the main beam assembly of the forward engine mount that would create an excessive gap between the bearing mono-ball and the snout. This proposed AD would require modifying the main beam assembly of the forward engine mount. We are proposing this AD to address the unsafe condition on these products.
Notice of Performance Review Board Membership
The purpose of the PRBs is to provide fair and impartial review of the annual SES performance appraisal prepared by the senior executive's immediate and second level supervisor; to make recommendations to appointing officials regarding acceptance or modification of the performance rating; and to make recommendations for performance bonuses and basic pay increases. Composition of the specific PRBs will be determined on an ad hoc basis from among the individuals listed below:
Proposed Memorandum of Understanding (MOU) Assigning Certain Federal Environmental Responsibilities to the State of Arizona, Including National Environmental Policy Act (NEPA) Authority for Certain Categorical Exclusions (CEs)
The FHWA and the State of Arizona, acting by and through its Department of Transportation (State), propose participation of the State in the Categorical Exclusion Assignment program. This Program allows FHWA to assign to States its authority and responsibility for determining whether certain designated activities within the geographic boundaries of the State, as specified in the proposed Memorandum of Understanding (MOU), are categorically excluded from preparation of an environmental assessment or an environmental impact statement under the National Environmental Policy Act.
Notice of Intent To Grant Exclusive Patent License; Taoglas USA, Inc.
The Department of the Navy hereby gives notice of its intent to grant an exclusive license to Taoglas USA, Inc. of San Diego, CA. The proposed license is a revocable, nonassignable, exclusive license to practice the invention embodied in U.S. Pat. App. Ser. No. 15/ 267,219: BROADBAND CIRCULARLY POLARIZED ANTENNA in the fields of use of automotive and Internet of Things (IoT) throughout the United States, the District of Columbia, the Commonwealth of Puerto Rico, and all other United States territories and possessions. The Secretary of the Navy has an ownership interest in this invention.
Airworthiness Directives; Dassault Aviation Airplanes
We propose to adopt a new airworthiness directive (AD) for all Dassault Aviation Model FAN JET FALCON, FAN JET FALCON SERIES D, E, F, and G airplanes; and certain Model MYSTERE-FALCON 20-C5, 20-D5, 20-E5, and 20-F5 airplanes. This proposed AD was prompted by reports of the collapse of the main landing gear on touchdown. This proposed AD would require an electrical modification of the landing gear sequence logic. We are proposing this AD to address the unsafe condition on these products.
Airworthiness Directives; Dassault Aviation Airplanes
We propose to adopt a new airworthiness directive (AD) for certain Dassault Aviation Model MYSTERE-FALCON 900, FALCON 900EX, FALCON 2000, and FALCON 2000EX airplanes. This proposed AD was prompted by reports of a loose screw on certain slat mechanical stop assemblies, and punctures in certain fuel caps. This proposed AD would require a one-time inspection, and corrective action if necessary. We are proposing this AD to address the unsafe condition on these products.
United States Navy Danger Zone, East Pearl River, Within the Acoustic Buffer Area of the John C. Stennis Space Center, and Adjacent to Lands, in Hancock County, Mississippi
The U.S. Army Corps of Engineers published a document in the Federal Register on December 14, 2016, proposing to revise its regulations to establish a danger zone in the East Pearl River within the acoustic buffer of NASA's John C. Stennis Space Center on the East Pearl River, in Hancock County, Mississippi. The Navy requested establishment of a danger zone on waterways and tributaries of the East Pearl River that are used by Naval Special Warfare units to conduct riverine training exercises. The purpose of the danger zone is to ensure public safety by restricting access within the danger zone during training events.
Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMB
The Board of Governors of the Federal Reserve System (Board) is adopting a proposal to extend for three years, without revision, the Government Securities Dealers Reports (FR 2004; OMB No. 7100-0003) and a proposal to extend for three years, with revision, the voluntary Weekly Report of Selected Assets and Liabilities of Domestically Chartered Commercial Banks and U.S. Branches and Agencies of Foreign Banks (FR 2644; OMB No. 7100-0075). The FR 2644 revisions are effective as of January 3, 2018. On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve of and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board. Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the Paperwork Reduction Act Submission, supporting statements and approved collection of information instrument(s) are placed into OMB's public docket files. The Federal Reserve may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.
Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Snapper-Grouper Fishery of the South Atlantic Region; Amendment 41
NMFS proposes to implement management measures described in Amendment 41 to the Fishery Management Plan (FMP) for the Snapper- Grouper Fishery of the South Atlantic Region (Snapper-Grouper FMP), as prepared and submitted by the South Atlantic Fishery Management Council (South Atlantic Council). If implemented, this proposed rule would revise commercial and recreational annual catch limits (ACLs), the minimum size limit, commercial trip limits, and the recreational bag limit for mutton snapper in the South Atlantic based on the results of the most recent stock assessment. The purpose of this proposed rule is to ensure that mutton snapper is managed based on the best scientific information available to achieve optimum yield (OY) and to prevent overfishing, while minimizing adverse social and economic effects to the extent practicable.
Notice of Revocation of Customs Brokers' Licenses
This document provides notice of the revocation by operation of law of customs brokers' licenses.
Notice of Advisory Council on Historic Preservation Quarterly Business Meeting
Notice is hereby given that the Advisory Council on Historic Preservation (ACHP) will hold its next quarterly meeting on Thursday, November 9 2017. The meeting will be held in Room SR325 at the Russell Senate Office Building at Constitution and Delaware Avenues NE., Washington, DC, starting at 8:30 a.m.
Collection of Information Under Review by Office of Management and Budget; OMB Control Number: 1625-0064
In compliance with the Paperwork Reduction Act of 1995 the U.S. Coast Guard is forwarding an Information Collection Request (ICR), abstracted below, to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting approval for reinstatement, without change, of the following collection of information: 1625-0064, Plan Approval and Records for Subdivision and Stability Regulations. Our ICR describes the information we seek to collect from the public. Review and comments by OIRA ensure we only impose paperwork burdens commensurate with our performance of duties.
Collection of Information Under Review by Office of Management and Budget; OMB Control Number: 1625-0073
In compliance with the Paperwork Reduction Act of 1995 the U.S. Coast Guard is forwarding an Information Collection Request (ICR), abstracted below, to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting approval for reinstatement, without change, of the following collection of information: 1625-0073, Alteration of Unreasonably Obstructive Bridges. Our ICR describes the information we seek to collect from the public. Review and comments by OIRA ensure we only impose paperwork burdens commensurate with our performance of duties.
Collection of Information Under Review by Office of Management and Budget; OMB Control Number: 1625-0017
In compliance with the Paperwork Reduction Act of 1995 the U.S. Coast Guard is forwarding an Information Collection Request (ICR), abstracted below, to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting approval for reinstatement, without change, of the following collection of information: 1625-0017, Various International Agreement Safety Certificates and Documents. Our ICR describe the information we seek to collect from the public. Review and comments by OIRA ensure we only impose paperwork burdens commensurate with our performance of duties.
Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMB
The Board of Governors of the Federal Reserve System (Board) is adopting a proposal to implement the Survey of Household Economics and Decisionmaking (FR 3077; OMB No. 7100-NEW). On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve of and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board. Board- approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the Paperwork Reduction Act Submission, supporting statements and approved collection of information instrument(s) are placed into OMB's public docket files. The Federal Reserve may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.
Medical Devices; Immunology and Microbiology Devices; Classification of the Zinc Transporter 8 Autoantibody Immunological Test System
The Food and Drug Administration (FDA or we) is classifying the zinc transporter 8 autoantibody immunological test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the zinc transporter 8 autoantibody immunological test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
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