December 18, 2023 – Federal Register Recent Federal Regulation Documents

Results 51 - 100 of 104
International Mailing Services: Price Changes
Document Number: 2023-27760
Type: Rule
Date: 2023-12-18
Agency: Postal Service, Agencies and Commissions
On October 6, 2023, the Postal Service published notice of mailing services price adjustments with the Postal Regulatory Commission (PRC). The PRC concluded that the price adjustments contained in the Postal Service's notification may go into effect on January 21, 2024. The Postal Service will revise Notice 123, Price List, to reflect the new mailing services prices.
Safety Zone, Illinois River MM 165-166, Peoria, IL
Document Number: 2023-27757
Type: Rule
Date: 2023-12-18
Agency: Coast Guard, Department of Homeland Security
The Coast Guard is establishing a temporary safety zone for all navigable waters in the Illinois River between Mile Marker (MM) 165.2 to 166.3. The safety zone is needed to protect personnel, vessels, and the marine environment from all potential hazards associated with the McClugage Bridge arch installation. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port (COTP) Sector Upper Mississippi River or a designated representative.
Submission for Office of Management and Budget Review; Temporary Assistance for Needy Families Expenditure Report, Form ACF-196R
Document Number: 2023-27756
Type: Notice
Date: 2023-12-18
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) Office of Family Assistance (OFA) is requesting a 3-year extension of the Temporary Assistance for Needy Families (TANF) Expenditure Report, Form ACF-196R (Office of Management and Budget (OMB) #0970-0446 expires February 29, 2024). ACF is proposing minor updates to the form to update references to lapsed timeframes, add demonstrative tables that aid in a recipient's comprehension of reporting requirements, incorporate minor edits to the instructions, and to adjust formatting to improve presentation.
Combined Notice of Filings #1
Document Number: 2023-27753
Type: Notice
Date: 2023-12-18
Agency: Department of Energy, Federal Energy Regulatory Commission
Combined Notice of Filings
Document Number: 2023-27752
Type: Notice
Date: 2023-12-18
Agency: Department of Energy, Federal Energy Regulatory Commission
Fisheries of the Northeastern United States; Northeast Multispecies Fishery; Gulf of Maine Cod Trimester Total Allowable Catch Area Closure and Possession Limit Adjustments for the Common Pool Fishery
Document Number: 2023-27748
Type: Rule
Date: 2023-12-18
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
This action prohibits possession of Gulf of Maine cod by common pool vessels through the end of fishing year. This action also closes the Gulf of Maine Cod Trimester Total Allowable Catch Area to Northeast multispecies common pool vessels fishing with trawl gear, sink gillnet gear, and longline/hook gear for Trimester 3 of fishing year 2023. These actions are necessary because the common pool fishery is projected to have achieved the annual sub-annual catch limit and caught more than 90 percent of its Trimester 3 quota for Gulf of Maine cod. This action is intended to prevent overages of the common pool's quota for this stock.
Environmental Management Site-Specific Advisory Board, Paducah
Document Number: 2023-27747
Type: Notice
Date: 2023-12-18
Agency: Department of Energy
This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Paducah. The Federal Advisory Committee Act requires that public notice of this meeting be announced in the Federal Register.
Proposed Collection; Comment Request
Document Number: 2023-27730
Type: Notice
Date: 2023-12-18
Agency: Department of Defense, Office of the Secretary
In compliance with the Paperwork Reduction Act of 1995, the Defense Health Agency (DHA) announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.
Proposed Collection; Comment Request
Document Number: 2023-27728
Type: Notice
Date: 2023-12-18
Agency: Department of Defense, Department of the Army
In compliance with the Paperwork Reduction Act of 1995, the USACE announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.
Proposed Collection; Comment Request
Document Number: 2023-27727
Type: Notice
Date: 2023-12-18
Agency: Department of Defense, Office of the Secretary
In compliance with the Paperwork Reduction Act of 1995, the Defense Advisory Committee on Women in the Services (DACOWITS) announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.
Agency Information Collection Activities; Comment Request; Evaluation of Full-Service Community Schools
Document Number: 2023-27726
Type: Notice
Date: 2023-12-18
Agency: Department of Education
In accordance with the Paperwork Reduction Act (PRA) of 1995, the Department is proposing a new information collection request (ICR).
Notice of OFAC Sanctions Actions
Document Number: 2023-27725
Type: Notice
Date: 2023-12-18
Agency: Department of the Treasury, Office of Foreign Assets Control
The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List (SDN List) based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.
Limitation of Duty-Free Imports of Apparel Articles Assembled in Haiti Under the Caribbean Basin Economic Recovery Act (CBERA), as Amended by the Haitian Hemispheric Opportunity Through Partnership Encouragement Act (HOPE)
Document Number: 2023-27723
Type: Notice
Date: 2023-12-18
Agency: Department of Commerce, International Trade Administration
CBERA, as amended, provides duty-free treatment for certain apparel articles imported directly from Haiti. One of the preferences is known as the ``value-added'' provision, which requires that apparel meet a minimum threshold percentage of value added in Haiti, the United States, and/or certain beneficiary countries. The provision is subject to a quantitative limitation, which is calculated as a percentage of total apparel imports into the United States for each 12-month period. For the period from December 20, 2023 through December 19, 2024, the quantity of imports eligible for preferential treatment under the value-added provision is 313,655,640 square meters equivalent.
Proposed Collection; Comment Request
Document Number: 2023-27721
Type: Notice
Date: 2023-12-18
Agency: Department of Defense, Office of the Secretary
In compliance with the Paperwork Reduction Act of 1995, the Under Secretary of Defense for Personnel and Readiness announces a proposed data collection and seeks public comment on the provisions thereof. Comments are invited on: whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.
Proposed Collection; Comment Request; Correction
Document Number: 2023-27720
Type: Notice
Date: 2023-12-18
Agency: Department of Defense, Office of the Secretary
On November 1, 2023, the DoD published a notice in the Federal Register. Subsequent to publication of the notice, the information in the FOR FURTHER INFORMATION CONTACT section changed. This correction provides the updated information.
Kasugamycin; Extension of Time-Limited Tolerance for Emergency Exemption
Document Number: 2023-27654
Type: Rule
Date: 2023-12-18
Agency: Environmental Protection Agency
This regulation extends time-limited tolerances for residues of kasugamycin in or on almond and almond, hulls as identified in this document. This action is in response to EPA's granting of an emergency exemption under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of this pesticide. In addition, the Federal Food, Drug, and Cosmetic Act (FFDCA) requires EPA to establish a time- limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA. Further, EPA issued a final rule in the Federal Register of November 3, 2023, that extended time-limited tolerances for multiple chemicals on various commodities in response to EPA's granting of emergency exemptions. EPA inadvertently omitted the detailed instructions for the revision of the tolerances for kasugamycin. Therefore, EPA is issuing this final rule to rectify this omission.
Significant New Use Rules on Certain Chemical Substances (22-2.5e)
Document Number: 2023-27653
Type: Rule
Date: 2023-12-18
Agency: Environmental Protection Agency
EPA is issuing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for certain chemical substances that were the subject of premanufacture notices (PMNs) and are also subject to an Order issued by EPA pursuant to TSCA. The SNURs require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA's evaluation of the use, under the conditions of use for that chemical substance, within the applicable review period. Persons may not commence manufacture or processing for the significant new use until they have submitted a Significant New Use Notice (SNUN), and EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required by that determination.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; A Survey on Quantitative Claims in Direct-to-Consumer Prescription Drug Advertising
Document Number: 2023-27652
Type: Notice
Date: 2023-12-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Inbound Competitive PRIME Registered Service Agreement
Document Number: 2023-27651
Type: Notice
Date: 2023-12-18
Agency: Postal Regulatory Commission, Agencies and Commissions
The Commission acknowledges a recent Postal Service request regarding revised versions and updates concerning parties to Inbound Competitive Registered Service Agreement 1. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Notice of Intent To Prepare an Environmental Impact Statement for the Sparrows Point Container Terminal, Patapsco River, Baltimore County, Maryland
Document Number: 2023-27650
Type: Notice
Date: 2023-12-18
Agency: Department of Defense, Department of the Army, Corps of Engineers
The U.S. Army Corps of Engineers, Baltimore District (Corps), has received an application for a Department of the Army (DA) permit (Corps number NAB-2023-61200) for the Sparrows Point Container Terminal project from Tradepoint TiL Terminal, LLC, a joint venture between Tradepoint Atlantic and Terminal Investments Limited to construct a new container terminal in the Port of Baltimore. The Corps, as the lead agency under the National Environmental Policy Act (NEPA), has determined the proposed project may significantly affect the quality of the human environment and intends to prepare an environmental impact statement (EIS). The Corps action will be to issue, issue with modifications, or deny a DA permit for the proposed project. The EIS will assess the potential social, economic, and environmental impacts of the proposed project. The Corps is requesting public/agency comments regarding the scope of the EIS and issues that should be evaluated in the document.
Initiation of Prioritization Under the Toxic Substances Control Act (TSCA); Request for Comment
Document Number: 2023-27641
Type: Notice
Date: 2023-12-18
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is announcing the initiation of and soliciting public comment on the prioritization process for five chemical substances as candidates for designation as High-Priority Substances for risk evaluation under the Toxic Substances Control Act (TSCA) and related implementing regulations. This document provides the identity of the chemical substances being initiated for prioritization, a general explanation of why the Agency chose these chemical substances, and information on the data sources that EPA plans to use to support the designation. EPA is providing a 90-day comment period, during which interested persons may submit relevant information on these chemical substances.
Request for Information To Support the Development of a Federal Environmental Justice Science, Data, and Research Plan; Reopening of Comment Period
Document Number: 2023-27632
Type: Notice
Date: 2023-12-18
Agency: Science and Technology Policy Office, Executive Office of the President
On October 13, 2023, the Office of Science and Technology Policy (OSTP) published in the Federal Register a document entitled ``Request for Information to Support the Development of a Federal Environmental Justice Science.'' This RFI invited comments to the Subcommittee on Environmental Justice formed under the National Science and Technology Council Committee on the Environment in support of developing a coordinated Federal strategy to identify and address gaps in science, data, and research related to environmental justice. Information received through this RFI will inform the biennial Environmental Justice Science, Data, and Research Plan (Research Plan). Executive Order 14096 directed the formation of both the Subcommittee on Environmental Justice and the development of the Research Plan. In response to requests by prospective commenters that they would benefit from additional time to adequately consider and respond to the RFI, OSTP has determined that a reopening of the comment period until January 12, 2024 is appropriate.
Request for Information Regarding Department of Homeland Security Activities and Advancing Environmental Justice
Document Number: 2023-27628
Type: Notice
Date: 2023-12-18
Agency: Department of Homeland Security
The Department of Homeland Security (DHS or Department) is comprised of 15 Operational and Support Components with far-reaching programs and activities. With this Request for information (RFI), DHS is seeking public comment and feedback on how environmental justice is considered Department-wide, how it can provide opportunities for meaningful engagement in decision-making, and what to include in the next DHS Environmental Justice Strategy. The public is encouraged to provide input in response to the questions in this RFI and to share barriers and challenges, successes, suggestions, and ideas. DHS will use this information to help improve and advance the Department's environmental justice program, conduct meaningful engagement, and address environmental justice challenges that communities are facing.
Social Security Number Fraud Prevention Act
Document Number: 2023-27616
Type: Proposed Rule
Date: 2023-12-18
Agency: Department of Energy
The Department of Energy (DOE or Department) proposes to revise its regulations regarding records maintained on individuals under the Privacy Act. The revisions would clarify and update procedural requirements pertaining to the inclusion of a Social Security Number (SSN) on documents that the Department sends by mail. These revisions are necessary to implement the SSN Fraud Prevention Act of 2017's restriction on the inclusion of SSNs on documents sent by mail by the Federal Government. Additionally, the Department proposes to maintain a publicly available list authorizing certain designated documents to include SSNs if: inclusion is necessary; and the documents are requested by individuals outside DOE or other Federal agencies. This Notice of Proposed Rulemaking (NOPR) seeks comment on this proposal.
Establishment of United States Area Navigation (RNAV) Routes T-440, T-455, T-457, T-459, and T-476, and Amendment of RNAV Routes T-358, T-416, and T-445; Eastern United States
Document Number: 2023-27606
Type: Rule
Date: 2023-12-18
Agency: Federal Aviation Administration, Department of Transportation
This action corrects a final rule published by the FAA in the Federal Register on November 24, 2023, that establishes United States Area Navigation (RNAV) routes T-440, T-455, T-457, T-459, and T-476, and amends RNAV routes T-358, T-416, and T-445 in support of the FAA's Very High Frequency Omnidirectional Range (VOR) Minimum Operational Network (MON) Program.
Airworthiness Directives; Embraer S.A. (Type Certificate Previously Held by Yaborã Indústria Aeronáutica S.A.; Embraer S.A.; Empresa Brasileira de Aeronáutica S.A. (EMBRAER)) Airplanes
Document Number: 2023-27678
Type: Rule
Date: 2023-12-18
Agency: Federal Aviation Administration, Department of Transportation
The FAA is adopting a new airworthiness directive (AD) for certain Embraer S.A. Model EMB-135BJ airplanes. This AD was prompted by reports of missing sealant on the rivets installed in the interface between rib 3 and the wing skin. This AD requires applying sealant on the rivets installed in the interface between rib 3 and wing skin, as specified in an Ag[ecirc]ncia Nacional de Avia[ccedil][atilde]o Civil (ANAC) AD, which is incorporated by reference. The FAA is issuing this AD to address the unsafe condition on these products.
Airworthiness Directives; Airbus Canada Limited Partnership (Type Certificate Previously Held by C Series Aircraft Limited Partnership (CSALP); Bombardier, Inc.) Airplanes
Document Number: 2023-27677
Type: Rule
Date: 2023-12-18
Agency: Federal Aviation Administration, Department of Transportation
The FAA is adopting a new airworthiness directive (AD) for certain Airbus Canada Limited Partnership Model BD-500-1A10 and BD-500- 1A11 airplanes. This AD was prompted by a reported interference between the pilot valve fittings and their mating holes in the rear spar of the center wing box (CWB). This AD requires replacing the pilot valve fittings, as specified in a Transport Canada AD, which is incorporated by reference. The FAA is issuing this AD to address the unsafe condition on these products.
Submission for OMB Review; Comment Request
Document Number: 2023-27672
Type: Notice
Date: 2023-12-18
Agency: Department of Agriculture
Regulation Q; Regulatory Capital Rules: Risk-Based Capital Surcharges for Global Systemically Important Bank Holding Companies
Document Number: 2023-27671
Type: Notice
Date: 2023-12-18
Agency: Federal Reserve System, Agencies and Commissions
The Board is providing notice of the 2023 aggregate global indicator amounts, as required under the Board's rule regarding risk- based capital surcharges for global systemically important bank holding companies (GSIB surcharge rule).
Modification of Class E Airspace; Klawock Airport, Klawock, AK
Document Number: 2023-27670
Type: Proposed Rule
Date: 2023-12-18
Agency: Federal Aviation Administration, Department of Transportation
This action proposes to modify the Class E airspace extending upward from 700 feet above the surface and remove the Class E airspace extending upward from 1,200 feet above the surface at Klawock Airport, Klawock, AK. Additionally, this action proposes administrative amendments to update the airport's existing Class E airspace legal description. These actions would support the safety and management of instrument flight rules (IFR) operations at the airport.
Intent To Reestablish the Black Hills National Forest Advisory Board and Solicitation of Nominations for Membership for the Black Hills National Forest Advisory Board AGENCY: Forest Service, Agriculture (USDA).
Document Number: 2023-27669
Type: Notice
Date: 2023-12-18
Agency: Department of Agriculture, Forest Service
In accordance with the Forest and Rangeland Renewable Resources Planning Act of 1974 (RPA), the National Forest Management Act of 1976 (NFMA), the Federal Lands Recreation Enhancement Act (REA), and the Federal Advisory Committee Act (FACA), the United States Department of Agriculture announces its intent through its Secretary to reestablish the Black Hills National Forest Advisory Board. The Black Hills National Forest Advisory Board will advise the Secretary of Agriculture on programmatic forest issues and project level issues that have forest-wide implications. The Black Hills National Forest Advisory Board will be governed by the provisions of FACA. Duration of the Black Hills National Forest Advisory Board is for two years unless renewed by the Secretary, USDA. This notice also solicits nominations for membership on the Black Hills National Forest Advisory Board.
Data Collection Available for Public Comments
Document Number: 2023-27668
Type: Notice
Date: 2023-12-18
Agency: Small Business Administration, Agencies and Commissions
The Small Business Administration (SBA) intends to request approval, from the Office of Management and Budget (OMB) for the collection of information described below. The Paperwork Reduction Act (PRA) of 1995 requires federal agencies to publish a notice in the Federal Register concerning each proposed collection of information before submission to OMB, and to allow 60 days for public comment in response to the notice. This notice complies with that requirement.
Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company
Document Number: 2023-27666
Type: Notice
Date: 2023-12-18
Agency: Federal Reserve System, Agencies and Commissions
Amendment and Revocation of Multiple Air Traffic Service (ATS) Routes; Eastern United States
Document Number: 2023-27664
Type: Proposed Rule
Date: 2023-12-18
Agency: Federal Aviation Administration, Department of Transportation
This action proposes to amend multiple Very High Frequency Omnidirectional Range (VOR) Federal airways; and revoke one VOR Federal airway and one Colored Federal airway in the eastern United States. This action is in support of the FAA's VOR Minimum Operational Network (MON) Program. The purpose is to enhance the efficiency of the National Airspace System (NAS) by transitioning from ground-based navigation aids to a satellite-based navigation system.
Reporting and Recordkeeping Requirements Under OMB Review
Document Number: 2023-27663
Type: Notice
Date: 2023-12-18
Agency: Small Business Administration, Agencies and Commissions
The Small Business Administration (SBA) is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act and OMB procedures, SBA is publishing this notice to allow all interested member of the public an additional 30 days to provide comments on the proposed collection of information.
Pharmacyclics LLC.; Withdrawal of Approval of Indications for Mantle Cell Lymphoma and Marginal Zone Lymphoma for IMBRUVICA (ibrutinib) Capsules and Tablets
Document Number: 2023-27662
Type: Notice
Date: 2023-12-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing that it is withdrawing approval of the indications for mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL) for IMBRUVICA (ibrutinib) Capsules and Tablets approved, respectively, under new drug applications (NDAs) 205552 and 210563. These NDAs are held by Pharmacyclics LLC, 1000 Gateway Blvd., South San Francisco, CA 94080 (Pharmacyclics). Pharmacyclics voluntarily requested that the Agency withdraw approval of these indications and waived its opportunity for a hearing.
Hoffmann-La Roche, Inc., et al.; Withdrawal of Approval of Two New Drug Applications
Document Number: 2023-27661
Type: Notice
Date: 2023-12-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is withdrawing approval of two new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Renaming of Restricted Areas R-5311A, R-5311B, and R-5311C; Fort Bragg, NC
Document Number: 2023-27660
Type: Rule
Date: 2023-12-18
Agency: Federal Aviation Administration, Department of Transportation
This action corrects a typographic error in the final rule published in the Federal Register on November 28, 2023, making an administrative change to rename restricted areas R-5311A, R-5311B, and R-5311C, Fort Bragg, NC, and updating the using agency description to reflect the change. Additionally, geographic coordinate technical amendments for two boundary points listed in the restricted areas were made to accurately align the existing boundary with the Little River referenced in the descriptions.
Renaming of Restricted Areas R-2103A and R-2103B; Fort Rucker, AL
Document Number: 2023-27659
Type: Rule
Date: 2023-12-18
Agency: Federal Aviation Administration, Department of Transportation
This action corrects a typographic error in the final rule published in the Federal Register on November 24, 2023, making an administrative change to rename restricted areas R-2103A and R-2103B, Fort Rucker, AL, and updating the using agency description to reflect the change.
Amendment of United States Area Navigation (RNAV) Routes; Eastern United States
Document Number: 2023-27658
Type: Proposed Rule
Date: 2023-12-18
Agency: Federal Aviation Administration, Department of Transportation
This action proposes to establish three and amend three United States Area Navigation (RNAV) T-routes in the eastern United States. This action supports Next Generation Air Transportation System (NextGen) which provides a modern RNAV route structure to improve the efficiency of the National Airspace System (NAS).
Large Power Transformers From South Korea; Notice of Commission Determination To Conduct a Full Five-Year Review
Document Number: 2023-27657
Type: Notice
Date: 2023-12-18
Agency: International Trade Commission, Agencies and Commissions
The Commission hereby gives notice that it will proceed with a full review pursuant to the Tariff Act of 1930 to determine whether revocation of the antidumping duty order on large power transformers from South Korea would be likely to lead to continuation or recurrence of material injury within a reasonably foreseeable time. A schedule for the review will be established and announced at a later date.
Priority Zoonotic Animal Drug Designation and Review Process; Draft Guidance for Industry; Availability
Document Number: 2023-27655
Type: Notice
Date: 2023-12-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #283 entitled ``Priority Zoonotic Animal Drug Designation and Review Process.'' This draft guidance is intended to assist sponsors pursuing priority zoonotic animal drug (PZAD) designation for a new animal drug. This draft guidance is intended to provide the eligibility criteria for PZAD designation, the process for requesting PZAD designation, and enhancements in the FDA review process for PZADs.
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