September 13, 2022 – Federal Register Recent Federal Regulation Documents
Results 1 - 50 of 125
Notice of Open Meeting
In accordance with the requirements of the Federal Advisory Committee Act, the Millennium Challenge Corporation (MCC) Economic Advisory Council was established as a discretionary advisory committee on October 5, 2018. Its charter was renewed for a second term on October 1, 2020. The MCC Economic Advisory Council serves MCC solely in an advisory capacity and provides advice and guidance to MCC economists, evaluators, leadership of the Department of Policy and Evaluation, and senior MCC leadership regarding relevant trends in development economics, applied economic and evaluation methods, poverty analytics, as well as modeling, measuring, and evaluating development interventions. In doing so, the MCC Economic Advisory Council helps sharpen MCC's analytical methods and capacity in support of the agency's economic development goals. It also serves as a sounding board and reference group for assessing and advising on strategic policy innovations and methodological directions in MCC.
Performance Review Board Membership
Each agency is required to establish, in accordance with regulations prescribed by the Office of Personnel Management, one or more Senior Executive Service (SES) Performance Review Boards (PRBs). The PRB shall review and evaluate the initial summary rating of a senior executive's performance, the executive's response, and any higher-level review's comments on the initial summary rating. In addition, the PRB will review and recommend executive performance bonuses and pay increases.
Mikart, LLC, et al.; Withdrawal of Approval of 31 Abbreviated New Drug Applications; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on July 12, 2022. The document announced the withdrawal of approval (as of August 11, 2022) of 31 abbreviated new drug applications (ANDAs) from multiple applicants. The document indicated that FDA was withdrawing approval of the following ANDAs after receiving withdrawal requests from USpharma Windlas, LLC, 115 Blue Jay Dr., Suite 101, Liberty, MO 64068: ANDA 204180, Amiloride Hydrochloride Tablets, 5 milligrams (mg); and ANDA 205790, Prasugrel Tablets, Equivalent to (EQ) 5 mg base and EQ 10 mg base. Before FDA withdrew the approval of these ANDAs, USpharma Windlas, LLC, informed FDA that it did not want the approval of the ANDAs withdrawn. Because USpharma Windlas, LLC, timely requested that approval of ANDAs 204180 and 205790 not be withdrawn, the approvals are still in effect.
Determination of Regulatory Review Period for Purposes of Patent Extension; REYVOW
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for REYVOW and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Alternative or Streamlined Mechanisms for Complying With the Current Good Manufacturing Practice Requirements for Combination Products; List Under the 21st Century Cures Act
As required by the 21st Century Cures Act (Cures Act), the Food and Drug Administration (FDA, Agency, or we) is finalizing a list of alternative or streamlined mechanisms for complying with the current good manufacturing practice (CGMP) requirements for combination products. A combination product is a product composed of any combination of a drug, a device, and/or a biological product.
Receipt of Incidental Take Permit Application and Proposed Habitat Conservation Plan for the Sand Skink and Blue-Tailed Mole Skink; Polk County, FL; Categorical Exclusion
We, the Fish and Wildlife Service (Service), announce receipt of an application from Robbins Investment Company, LLC (applicant) for an incidental take permit (ITP) under the Endangered Species Act. The applicant requests the ITP to take the federally listed sand skink and blue-tailed mole skink incidental to the construction and operation of a commercial development in Polk County, Florida. We request public comment on the application, which includes the applicant's proposed habitat conservation plan (HCP), and on the Service's preliminary determination that this HCP qualifies as ``low effect,'' categorically excluded under the National Environmental Policy Act. To make this determination, we used our environmental action statement and low- effect screening form, both of which are also available for public review.
Receipt of Incidental Take Permit Application and Proposed Habitat Conservation Plan for the Sand Skink and Blue-Tailed Mole Skink; Polk County, FL; Categorical Exclusion
We, the Fish and Wildlife Service (Service), announce receipt of an application from CG Citrus, LLC (applicant) for an incidental take permit (ITP) under the Endangered Species Act. The applicant requests the ITP to take the federally listed sand skink and blue- tailed mole skink incidental to the construction of a residential development in Polk County, Florida. We request public comment on the application, which includes the applicant's proposed habitat conservation plan (HCP), and on the Service's preliminary determination that this HCP qualifies as ``low effect,'' categorically excluded under the National Environmental Policy Act. To make this determination, we used our environmental action statement and low-effect screening form, both of which are also available for public review.
Agency Information Collection Activities; Proposed eCollection; eComments Requested; Extension Without Change of a Currently Approved Collection. Requirement That Movie Theaters Provide Notice as to the Availability of Closed Movie Captioning and Audio Description
The Disability Rights Section (DRS), Civil Rights Division, Department of Justice (the Department), will submit the following information collection extension request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA).
Policy for Monkeypox Tests To Address the Public Health Emergency; Guidance for Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Policy for Monkeypox Tests To Address the Public Health Emergency.'' On August 4, 2022, the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency related to monkeypox. Monkeypox virus is a zoonotic infection (a virus transmitted to humans from animals), caused by Orthopoxvirus genus of the Poxviridae family similar to variola virus (the causative agent of smallpox), and can spread to humans. Since early May 2022, cases of monkeypox have been reported from countries where the disease is not endemic and continue to be reported in several endemic countries. Rapid detection of monkeypox cases in the United States requires wide availability of diagnostic testing to control the emergence of this contagious infection. This guidance describes FDA's review priorities of emergency use authorization (EUA) requests for monkeypox diagnostic tests, as well as FDA's enforcement policies for various monkeypox tests. The guidance document has been implemented without prior comment, but it remains subject to comment in accordance with the Agency's good guidance practices.
Receipt of Incidental Take Permit Application and Proposed Habitat Conservation Plan for the Sand Skink and Blue-Tailed Mole Skink; Polk County, FL; Categorical Exclusion
We, the Fish and Wildlife Service (Service), announce receipt of an application from Polk County, Florida (applicant), for an incidental take permit (ITP) under the Endangered Species Act. The applicant requests the ITP to take the federally listed sand skink and blue-tailed mole skink incidental to the construction of roadway improvements at an existing paved-road intersection in Polk County, Florida. We request public comment on the application, which includes the applicant's proposed habitat conservation plan (HCP), and on the Service's preliminary determination that this HCP qualifies as ``low effect,'' categorically excluded under the National Environmental Policy Act. To make this determination, we used our environmental action statement and low-effect screening form, both of which are also available for public review.
Competitive Postal Products
The Commission is invites comments in this proceeding related to its analysis of subsequent events that impact the findings of a Federal Trade Commission Report. This document informs the public of this proceeding, invites public comment, and takes other administrative steps.
Special Local Regulations; Marine Events Within the Seventh Coast Guard District
The Captain of the Port (COTP) Savannah, Georgia will enforce a special local regulation for the Ironman Triathlon in Augusta, Georgia, on September 25, 2022, to provide for the safety of life on navigable waterways during this event. Our regulation for marine events within the Seventh Coast Guard District identifies the regulated area for this event in Augusta, GA. During the enforcement periods, the operator of any vessel in the regulated area must comply with directions from the Patrol Commander or any Official Patrol displaying a Coast Guard ensign.
Merck Sharp & Dohme Corp.; Withdrawal of Approval of New Drug Applications for VIOXX (Rofecoxib) Tablets and Suspension
The Food and Drug Administration (FDA or Agency) is withdrawing approval of the new drug applications (NDAs) for VIOXX (rofecoxib) Tablets, 12.5 milligrams (mg), 25 mg, and 50 mg, and VIOXX (rofecoxib) Suspension, 12.5 mg/5 milliliter (mL) and 25 mg/5 mL, held by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., P.O. Box 100, 1 Merck Dr., Whitehouse Station, NJ 08889 (Merck). Merck has voluntarily requested that FDA withdraw approval of these applications and has waived its opportunity for a hearing.
Cost-Based and Inter-Agency Billing Rates for Medical Care or Services Provided by the Department of Veterans Affairs for Fiscal Year 2023
This document updates the Cost-Based and Inter-Agency billing rates for medical care or services provided by the U.S. Department of Veterans Affairs (VA) furnished in certain circumstances.
Public Information
The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule amending its public information regulations. The final rule revises the current regulations to incorporate changes made to the Freedom of Information Act (FOIA) by the Openness Promotes Effectiveness in our National Government Act of 2007 (OPEN Government Act) and the FOIA Improvement Act of 2016 (FOIA Improvement Act). Additionally, the final rule updates the current regulations to reflect changes to the organizational structure of FDA, to make the FOIA process easier for the public to navigate, and to make provisions clearer.
Agency Information Collection Activity: Request for Details of Expenses
Veterans Benefits Administration, 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 revision of a currently approved collection, and allow 60 days for public comment in response to the notice.
Renewal of the Technology Advisory Committee
The Commodity Futures Trading Commission (Commission) is publishing this notice to announce the renewal of the Technology Advisory Committee (TAC). The Commission has determined that the renewal of the TAC is necessary and in the public's interest, and the Commission has consulted with the General Services Administration's Committee Management Secretariat regarding the TAC's renewal.
Prior Notice of Imported Food Questions and Answers (Edition 4); Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Prior Notice of Imported Food Questions and Answers; Draft Guidance for Industry (Edition 4).'' The draft guidance adds three additional questions. One question relates to any effect systems recognition or equivalency determinations have on prior notice requirements. The other two questions relate to FDA's notice to a submitter of prior notice of an FDA refusal for inadequate prior notice or hold if the food article is from a foreign facility that is not registered, and address the timeframe for making requests for FDA review of such a refusal or hold. FDA is also making other technical and editorial changes.
Determination of Regulatory Review Period for Purposes of Patent Extension; BULKAMID URETHRAL BULKING SYSTEM
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BULKAMID URETHRAL BULKING SYSTEM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Joint Meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Privacy Act of 1974; System of Records
Pursuant to the provisions of the Privacy Act of 1974, as amended, the Department of the Housing and Urban Development (HUD), Office of Policy Development & Research (PD&R) is issuing a public notice of its intent to establish a Privacy Act system of records titled the Stepped and Tiered Rent Demonstration Evaluation data files. The purpose of the Stepped and Tiered Rent Demonstration Evaluation data files system is to serve as a repository to store, maintain, and statistically analyze all data collected through the evaluation of the Stepped and Tiered Rent Demonstration.
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