2017 – Federal Register Recent Federal Regulation Documents
Results 8,551 - 8,600 of 27,453
Product Change-Priority Mail Negotiated Service Agreement
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Product Change-Priority Mail and First-Class Package Service Negotiated Service Agreement
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Product Change-Priority Mail and First-Class Package Service Negotiated Service Agreement
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Product Change-First-Class Package Service Negotiated Service Agreement
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Recording and Reporting Occupational Injuries and Illnesses; Extension of the Office of Management and Budget's (OMB) Approval of Information Collection (Paperwork) Requirements
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and impact of collection requirements on respondents can be properly assessed. The Occupational Safety and Health Administration (OSHA) is soliciting comments concerning the proposed extension of approval for the current information collection requirements of Recording and Reporting Occupational Injuries and Illnesses.
Certain Mirrors With Internal Illumination and Components Thereof;
Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (``ID'') (Order No. 10) finding the sole remaining respondent in default. The Commission requests written submissions, under the schedule set forth below, on remedy, public interest, and bonding.
Fisheries of the Northeastern United States; Scup Fishery; Adjustment to the 2017 Winter II Quota
NMFS adjusts the 2017 Winter II commercial scup quota and per trip Federal landing limit. This action is intended to comply with Framework Adjustment 3 to the Summer Flounder, Scup, and Black Sea Bass Fishery Management Plan that established the rollover of unused commercial scup quota from the Winter I period to the Winter II period. This notice is intended to inform the public of this quota and trip limit change.
Montana Second 10-Year Carbon Monoxide Maintenance Plan for Missoula
The Environmental Protection Agency (EPA) is proposing to approve a State Implementation Plan (SIP) revision submitted to the EPA by the State of Montana. On September 19, 2016, the Governor of Montana's designee submitted a Clean Air Act (CAA) section 175A(b) second 10-year limited maintenance plan for the Missoula area for the carbon monoxide (CO) National Ambient Air Quality Standard (NAAQS). This limited maintenance plan addresses maintenance of the CO NAAQS for a second 10-year period beyond the original redesignation. This action is being taken under sections 110 and 175A of the CAA.
Montana Second 10-Year Carbon Monoxide Maintenance Plan for Missoula
The Environmental Protection Agency (EPA) is taking direct final action approving a State Implementation Plan (SIP) revision submitted by the State of Montana. On September 19, 2016, the Governor of Montana submitted to the EPA a Clean Air Act (CAA) section 175A(b) second 10-year maintenance plan for the Missoula, Montana area for the carbon monoxide (CO) National Ambient Air Quality Standard (NAAQS). This limited maintenance plan (LMP) addresses maintenance of the CO NAAQS for a second 10-year period beyond the original redesignation. This action is being taken under sections 110 and 175A of the CAA.
Approval of California Air Plan Revisions, South Coast Air Quality Management District
The Environmental Protection Agency (EPA) is taking final action to approve revisions to the South Coast Air Quality Management District (SCAQMD or ``District'') portion of the California State Implementation Plan (SIP). These revisions concern emissions of oxides of nitrogen (NOX) and oxides of sulfur (SOX) from facilities that emit four or more tons per year of NOX or SOX, which are regulated by SCAQMD's Regional Clean Air Incentives Market (RECLAIM) program. We are approving revisions to local rules in the SIP that regulate these emission sources under the Clean Air Act (CAA or the Act).
Approval and Promulgation of Implementation Plans; New York; Reasonably Available Control Technology for the 2008 8-Hour Ozone National Ambient Air Quality Standards
The Environmental Protection Agency (EPA) is proposing to conditionally approve a State Implementation Plan (SIP) submitted by the State of New York for purposes of implementing Reasonably Available Control Technology (RACT) for the 2008 8-hour ozone National Ambient Air Quality Standard (NAAQS). This proposed approval is conditioned on New York's timely submittal of a supplement to the SIP that includes a revised regulatory RACT requirement related to control of volatile organic compounds from Industrial Cleaning Solvents. The EPA is proposing to approve New York's RACT SIP as it applies to non-control technique guideline major sources and major sources of oxides of nitrogen. The EPA is also proposing to approve the State of New York's non-attainment new source review certification as sufficient for purposes of satisfying the 2008 8-hour ozone NAAQS. This action is being taken in accordance with the requirements of the Clean Air Act.
Revisions to California State Implementation Plan; Bay Area Air Quality Management District; Emission Reduction Credit Banking
The Environmental Protection Agency (EPA) is proposing action on a revision to the Bay Area Air Quality Management District (BAAQMD or District) portion of the California State Implementation Plan (SIP). We are proposing a conditional approval of one rule. This revision consists of updates to provisions governing the issuance and banking of Emission Reduction Credits for use in the review and permitting of major sources and major modifications under part D of title I of the Clean Air Act (CAA). We are taking comments on this proposal and plan to follow with a final action.
Airworthiness Directives; Sikorsky Aircraft Corporation Helicopters
We propose to adopt a new airworthiness directive (AD) for Sikorsky Aircraft Corporation (Sikorsky) Model S-76C helicopters. This proposed AD would require inspecting the engine collective position transducer (CPT). This proposed AD is prompted by reports of wear of the CPT that has resulted in several One Engine Inoperative (OEI) incidents. The proposed actions are intended to detect and prevent an unsafe condition on these products.
Airworthiness Directives; Dassault Aviation Airplanes
We are adopting a new airworthiness directive (AD) for certain Dassault Aviation Model FALCON 900EX airplanes. This AD was prompted by a determination that new or more restrictive maintenance requirements and/or airworthiness limitations are necessary. This AD requires revising the maintenance or inspection program, as applicable, to incorporate new or more restrictive maintenance requirements and/or airworthiness limitations. 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 727 airplanes. This AD was prompted by analysis of the cam support assemblies of the main cargo door (MCD) that indicated the repetitive high frequency eddy current (HFEC) inspections required by the existing maintenance program are not adequate to detect cracks before two adjacent cam support assemblies of the MCD could fail. This AD requires repetitive ultrasonic inspections for cracking of the cam support assemblies of the MCD and replacement if necessary. We are issuing this AD to address the unsafe condition on these products.
Initial List of Actions To Enhance and Modernize the Federal Environmental Review and Authorization Process
The Council on Environmental Quality (CEQ) is publishing its initial list of actions pursuant to Executive Order 13807 of August 15, 2017, titled ``Establishing Discipline and Accountability in the Environmental Review and Permitting Process for Infrastructure Projects,'' and published on August 24, 2017.
U.S. Endangered Species; Receipt of Recovery Permit Applications
We, the U.S. Fish and Wildlife Service, invite the public to comment on applications for permits to conduct activities intended to enhance the propagation or survival of endangered species. With some exceptions, the Endangered Species Act (ESA) prohibits certain activities that constitute take of listed species unless a Federal permit is issued that allows such activity. The ESA also requires that we invite public comment before issuing these permits.
Hazardous Materials: Notice of Applications for Special Permits
In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations notice is hereby given that the Office of Hazardous Materials Safety has received the application described herein.
Hazardous Materials: Notice of Applications for Special Permits
In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations notice is hereby given that the Office of Hazardous Materials Safety has received the application described herein. Each mode of transportation for which a particular special permit is requested is indicated by a number in the ``Nature of Application'' portion of the table below as follows: 1 Motor vehicle, 2Rail freight, 3Cargo vessel, 4Cargo aircraft only, 5Passenger-carrying aircraft.
Airworthiness Directives; Airbus Airplanes
We are superseding Airworthiness Directive (AD) 2004-23-20, which applied to certain Airbus Model A300, A300 B4-600, and A300 B4- 600R series airplanes; and Model A300 F4-605R and A300 C4-605R Variant F airplanes. AD 2004-23-20 required, for certain airplanes, repetitive inspections for cracking around certain attachment holes, installation of new fasteners for certain airplanes, and follow-on corrective actions if necessary. AD 2004-23-20 also required modifying certain fuselage frames, which terminated certain repetitive inspections. This new AD reduces certain compliance times, expands the applicability, and requires an additional repair on certain modified airplanes. This AD was prompted by a report indicating that the material used to manufacture the upper frame feet was changed and negatively affected the fatigue life of the frame feet. We are issuing this AD to address the unsafe condition on these products.
Airworthiness Directives; Dassault Aviation Airplanes
We are adopting a new airworthiness directive (AD) for all Dassault Aviation Model MYSTERE-FALCON 900 airplanes. This AD was prompted by a determination that new or more restrictive maintenance requirements and/or airworthiness limitations are necessary. This AD requires revising the maintenance or inspection program, as applicable, to incorporate new or more restrictive maintenance requirements and/or airworthiness limitations. We are issuing this AD to address the unsafe condition on these products.
Bureau of Indian Education Standards, Assessments, and Accountability System Negotiated Rulemaking Committee Establishment; Nominations
The U.S. Department of the Interior is announcing its intent to establish the Bureau of Indian Education (BIE) Standards, Assessments, and Accountability System Negotiated Rulemaking Committee (Committee) to advise the Secretary of the Interior (Secretary) through the BIE on a proposed rule to revise the Adequate Yearly Progress regulation and invite Tribes whose students attend BIE-funded schools operated by either the BIE or by the Tribe through a contract or grant who would be affected by the final rule to nominate a representative for membership on the Committee. The BIE also invites nominations for Committee members who will adequately represent the interests that are likely to be significantly affected by the proposed rule such as: Students enrolled, or parents of students enrolled at the 174 BIE- funded schools, school teachers and administrators, Tribes, and Indian communities served by these schools. The BIE also solicits comments on the proposal to establish the Committee.
Airworthiness Directives; Airbus Airplanes
We are adopting a new airworthiness directive (AD) for all Airbus Model A300 B4-600R and Model A300 F4-600R series airplanes; Model A300 B4-603, B4-622, and C4-605R Variant F airplanes; and Model A310-203, -221, -222, -304, -322, -324, and -325 airplanes. This AD was prompted by an evaluation by the design approval holder indicating that a section of the fuselage structure above the forward cargo door is subject to widespread fatigue damage (WFD). This AD requires an inspection for cracks of the fastener and tooling holes at certain locations and a check of the diameter of the holes, and repair or modification of the affected fuselage structure if necessary. We are issuing this AD to address the unsafe condition on these products.
Airworthiness Directives; Airbus Airplanes
We are adopting a new airworthiness directive (AD) for all Airbus Model A310-203, -204, -221, -222, -304, -322, -324, and -325 airplanes. This AD was prompted by reports of cracking in the drainage holes on the lower skin panel in the center wing box between frames (FR) 42 and FR46. This AD requires repetitive rotating probe inspections for cracking of the trellis boom drainage holes, the holes in the stringers bottom, and the holes of the inner pump, and corrective actions if necessary. We are issuing this AD to address the unsafe condition on these products.
Arkansas: Final Authorization of State-Initiated Changes and Incorporation by Reference of State Hazardous Waste Management Program
During a review of Arkansas' regulations, the Environmental Protection Agency (EPA) identified a variety of State-initiated changes to Arkansas' hazardous waste program under the Resource Conservation and Recovery Act (RCRA), as amended. The EPA proposes to authorize the State for the program changes. In addition, the EPA proposes to codify in the regulations entitled ``Approved State Hazardous Waste Management Programs'', Arkansas' authorized hazardous waste program. The EPA will incorporate by reference into the Code of Federal Regulations (CFR) those provisions of the State regulations that are authorized and that the EPA will enforce under RCRA. The purpose of this Federal Register document is to codify Arkansas' base hazardous waste management program and its revisions to that program.
Arkansas: Final Authorization of State-Initiated Changes and Incorporation by Reference of Approved State Hazardous Waste Management Program
During a review of Arkansas' regulations, the Environmental Protection Agency (EPA) identified State-initiated changes to its hazardous waste program under the Resource Conservation and Recovery Act (RCRA). We have determined that these changes are minor and satisfy all requirements needed to qualify for final authorization and are authorizing the State-initiated changes through this direct final action.
Registration Review; Draft Human Health and/or Ecological Risk Assessments for Several Pesticides; Notice of Availability
This notice announces the availability of EPA's draft human health and/or ecological risk assessments for the registration review of asulam, chloroxylenol, dichlobenil, EPTC, etofenprox, gamma- and lambda-cyhalothrin, imidacloprid, indoxacarb, metribuzin, nitrapyrin, oxamyl, pendimethalin, permethrin, prometryn, pyrethrins, tau- fluvalinate, and trifloxystrobin. Registration review is EPA's periodic review of pesticide registrations to ensure that each pesticide continues to satisfy the statutory standard for registration, that is, the pesticide can perform its intended function without unreasonable adverse effects on human health or the environment. As part of the registration review process, the Agency has completed comprehensive draft human health and/or ecological risk assessments for all pesticides listed in the Table in Unit III. After reviewing comments received during the public comment period, EPA may issue a revised risk assessment, explain any changes to the draft risk assessment, and respond to comments and may request public input on risk mitigation before completing a proposed registration review decision for the pesticides listed in the Table in Unit III. Through this program, EPA is ensuring that each pesticide's registration is based on current scientific and other knowledge, including its effects on human health and the environment.
Agency Information Collection Activities; Proposed Renewal of an Existing Collection; Comment Request
In compliance with the Paperwork Reduction Act (PRA), this document announces that EPA is planning to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). The ICR, entitled: ``Plant-Incorporated Protectants; CBI Substantiation and Adverse Effects Reporting,'' and identified by EPA ICR No. 1693.09 and OMB Control No. 2070-0142, represents the renewal of an existing ICR that is scheduled to expire on May 31, 2018. Before submitting the ICR to OMB for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection that is summarized in this document. The ICR and accompanying material are available in the docket for public review and comment.
Product Cancellation Order for Certain Pesticide Registrations; Correction
EPA issued notices in the Federal Register of June 8, 2016, and July 5, 2017, concerning receipt of requests to voluntarily cancel certain pesticide registrations and its follow-up product cancellation order. In the notice of July 5, 2017, EPA inadvertently listed the pesticide products Dithiopyr 0.13% Plus Fertilizer (EPA Reg. No. 53883- 207), Dithiopyr 0.25% Plus Fertilizer (EPA Reg. No. 53883-208), Dithiopyr 0.172% Plus Fertilizer (EPA Reg. No. 53883-209), Dithiopyr 0.107% Plus Fertilizer (EPA Reg. No. 53883-210), Dithiopyr 0.06% Plus Fertilizer (EPA Reg. No. 53883-211), Dithiopyr 0.086% Plus Fertilizer (EPA Reg. No. 53883-212), Dithiopyr 0.1% Plus Fertilizer (EPA Reg. No. 53883-213), Dithiopyr Concentrate for Fertilizer (EPA Reg. No. 53883- 268) and Quali-Pro Dithiopyr 2L (EPA Reg. No. 53883-311). The registrant had responded with a letter to the Office of Pesticide Programs dated June 10, 2016 requesting that the nine products not be cancelled. The letter was never forwarded to be included in the public docket for this Federal Register notice so the products were listed in the notice of July 5, 2017, in error. Therefore, EPA is not cancelling the pesticide products Dithiopyr 0.13% Plus Fertilizer (EPA Reg. No. 53883-207), Dithiopyr 0.25% Plus Fertilizer (EPA Reg. No. 53883-208), Dithiopyr 0.172% Plus Fertilizer (EPA Reg. No. 53883-209), Dithiopyr 0.107% Plus Fertilizer (EPA Reg. No. 53883-210), Dithiopyr 0.06% Plus Fertilizer (EPA Reg. No. 53883-211), Dithiopyr 0.086% Plus Fertilizer (EPA Reg. No. 53883-212), Dithiopyr 0.1% Plus Fertilizer (EPA Reg. No. 53883-213), Dithiopyr Concentrate for Fertilizer (EPA Reg. No. 53883-268) and Quali-Pro Dithiopyr 2L (EPA Reg. No. 53883-311). This document removes the cancellation order for EPA Reg. Numbers 53883-207, 53883-208, 53883-209, 53883-210, 53883-211, 53883-212, 53883-213, EPA Reg. No. 53883-268 and 53883-311 listed in the July 5, 2017, Federal Register notice.
Drawbridge Operation Regulation; Gulf Intracoastal Waterway, Harvey, LA
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Harvey Canal Fourth Street Bridge across the Gulf Intracoastal Waterway (GIWW) mile 0.24 West of Harvey Lock (WHL), at Harvey, Louisiana. The deviation is necessary to allow the contractor to rehabilitate the bridge to continue full operation. This deviation allows the bridge to remain closed-to-navigation for 77 consecutive days.
EPTC; Pesticide Tolerances
This regulation establishes tolerances for residues of EPTC, S-ethyl dipropylthiocarbamate in or on grass, forage at 0.60 ppm and grass, hay at 0.50 ppm. Gowan Company requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Presidential Declaration of a Major Disaster for the U.S. Virgin Islands
This is a Notice of the Presidential declaration of a major disaster for the U.S. VIRGIN ISLANDS (FEMA-4335-DR), dated 09/07/2017. Incident: Hurricane Irma. Incident Period: 09/06/2017 and continuing.
National Center for Health Statistics (NCHS), ICD-10 Coordination and Maintenance (C&M) Committee Meeting
The Centers for Disease Control and Prevention, National Center for Health Statistics (NCHS), Classifications and Public Health Data Standards Staff, announces the following meeting of the ICD-10 Coordination and Maintenance (C&M) Committee meeting. This meeting is open to the public, limited only by the space available. The meeting room accommodates approximately 240 people. We will be broadcasting the meeting live via Webcast at https://www.cms.gov/live/.
Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board), National Institute for Occupational Safety and Health (NIOSH)
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC), announces the following meeting of the Advisory Board on Radiation and Worker Health (ABRWH). This meeting is open to the public, but without a public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcome to listen to the meeting by joining the teleconference at the USA toll-free, dial-in number at 1-866-659-0537; the pass code is 9933701. The conference line has 150 ports for callers.
Agency Forms Submitted for OMB Review, Request for Comments
In accordance with the Paperwork Reduction Act of 1995, the Railroad Retirement Board (RRB) is forwarding an Information Collection Request (ICR) to the Office of Information and Regulatory Affairs (OIRA), Office of Management and Budget (OMB). Our ICR describes the information we seek to collect from the public. Review and approval by OIRA ensures that we impose appropriate paperwork burdens. The RRB invites comments on the proposed collections of information to determine (1) the practical utility of the collections; (2) the accuracy of the estimated burden of the collections; (3) ways to enhance the quality, utility, and clarity of the information that is the subject of collection; and (4) ways to minimize the burden of collections on respondents, including the use of automated collection techniques or other forms of information technology. Comments to the RRB or OIRA must contain the OMB control number of the ICR. For proper consideration of your comments, it is best if the RRB and OIRA receive them within 30 days of the publication date. 1. Title and purpose of information collection: Supplemental Information on Accident and Insurance; OMB 3220-0036. Under Section 12(o) of the Railroad Unemployment Insurance Act (RUIA), the Railroad Retirement Board (RRB) is entitled to reimbursement of the sickness benefits paid to a railroad employee if the employee receives a sum or damages for the same infirmity for which the benefits are paid. Section 2(f) of the RUIA requires employers to reimburse the RRB for days in which salary, wages, pay for time lost or other remuneration is later determined to be payable. Reimbursements under section 2(f) generally result from the award of pay for time lost or the payment of guaranteed wages. The RUIA prescribes that the amount of benefits paid be deducted and held by the employer in a special fund for reimbursement to the RRB. The RRB currently utilizes Forms SI-1c, Supplemental Information on Accident and Insurance; SI-5, Report of Payments to Employee Claiming Sickness Benefits Under the RUIA; ID-3s and ID-3s (Internet), Request for Lien InformationReport of Settlement; ID-3s-1, Lien Information Under Section 12(o) of the RUIA; ID-3u and ID-3u (Internet), Request for Section 2(f) Information; ID-30k, Notice to Request Supplemental Information on Injury or Illness; and ID-30k-1, Notice to Request Supplemental Information on Injury or Illness; to obtain the necessary information from claimants and railroad employers. Completion is required to obtain benefits. One response is requested of each respondent. Previous Requests for Comments: The RRB has already published the initial 60-day notice (82 FR 31108 on July 5, 2017) required by 44 U.S.C. 3506(c)(2). That request elicited no comments.
60-Day Notice of Proposed Information Collection: Application for Healthy Homes and Lead Hazard Control Grant Programs and Quality Assurance Plans
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.
Fisheries of the South Atlantic, Gulf of Mexico, and Caribbean; Southeast Data, Assessment, and Review (SEDAR); Amendment
The SEDAR Steering Committee will meet to discuss the SEDAR process and assessment schedule.
Western Pacific Fishery Management Council; Public Meeting
The Western Pacific Fishery Management Council (Council) will hold a meeting of its Social Science Planning Committee (SSPC) in Honolulu, HI.
60-Day Notice of Proposed Information Collection: Performing Loan Servicing for the Home Equity Conversion Mortgage (HECM)
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.
Safety Zone; Allegheny River miles 0.0-0.25, Ohio River mile 0.0-0.1, Monongahela River mile 0.0-0.1; Pittsburgh, PA
The Coast Guard will enforce the subject safety zone for the Pittsburgh Steelers Fireworks on all navigable waters of the Allegheny River miles 0.0 to 0.25, Ohio River mile 0.0 to 0.1, Monongahela River mile 0.0 to 0.1, extending the entire width of the rivers. The zone is needed to protect vessels transiting the area and event spectators from the hazards associated with the barge-based fireworks display. During the enforcement period, entry into, transiting, or anchoring in the safety zone is prohibited to all vessels not registered with the sponsor as participants or official patrol vessels, unless specifically authorized by the Captain of the Port Marine Safety Unit Pittsburgh (COTP) or a designated representative.
Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations.'' This draft guidance is intended to assist developers of microdose radiopharmaceutical diagnostic drugs on the nonclinical studies recommended to support human clinical trials and marketing authorization. The draft guidance discusses how to refine nonclinical study recommendations for this class of drug given its unique characteristics. This draft guidance is intended to provide recommendations for a pathway to full drug development (marketing authorization) for microdose radiopharmaceutical diagnostic drugs.
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Compliance Dates for Subpart E
The Food and Drug Administration (FDA, the Agency, or we) is proposing to extend, for covered produce other than sprouts, the dates for compliance with the agricultural water provisions in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule. We are proposing to extend the compliance dates to address questions about the practical implementation of compliance with certain provisions and to consider how we might further reduce the regulatory burden or increase flexibility while continuing to achieve our regulatory objectives, in keeping with the Administration's policies.
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