🚫MSHA Proposes Extension for Smoking Prevention Program in Mines
The Department of Labor (DOL), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre- clearance consultation program for all information collections, to provide the public and Federal agencies with an opportunity to comment on proposed collections of information, in accordance with the Paperwork Reduction Act of 1995. 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 the impact of collection requirements on respondents can be properly assessed. The Mine Safety and Health Administration (MSHA) is soliciting comments on the information collection titled "Program to Prevent Smoking in Hazardous Areas of Underground Coal Mines."
Learn More🥚FDA Notice on Shell Egg Production and Safety Regulations
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.
Learn More🏥CDC Notice on Information Collection for Tuberculosis Program
The CDC has submitted a request for information collection under the Paperwork Reduction Act, specifically for the "Aggregate Reports for Tuberculosis Program Evaluation." This includes a 30-day comment period for the public and agencies to assess the necessity and utility of the proposed data collection efforts aimed at eliminating tuberculosis in the U.S.
Learn More🏭FDA Guidance on Alternative Tools for Drug Manufacturing Assessment
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications." This guidance provides information to applicants on how FDA intends to use alternative tools to assess drug manufacturing facilities identified in a marketing application (i.e., a new drug application (NDA), an abbreviated new drug application (ANDA), a biologics license application (BLA), or a supplement to any of these types of applications). As part of the negotiations relating to the reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Act (BsUFA), as described in "PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027" (PDUFA VII commitment letter) and "Biosimilar Biological Product Reauthorization Performance Goals and Procedures for Fiscal Years 2023 Through 2027" (BsUFA III commitment letter), FDA agreed to issue guidance on the use of alternative tools to assess manufacturing facilities named in pending applications and to incorporate best practices from the use of such tools during the Coronavirus Disease 2019 (COVID-19) pandemic. This guidance finalizes the draft guidance of the same title issued on September 22, 2023.
Learn More📄CDC Notice on Sudden Death in the Young Information Collection
The CDC announces a proposed information collection titled "Sudden Death in the Young," inviting public and agency comments on the collection's necessity and methodology. This process follows previous outreach for public feedback and aims to enhance data accuracy regarding child death incidences. The notice includes a call for comments within 30 days, highlighting the agency's collaborative efforts to improve health data collection.
Learn More⚒️DOL Notice on Mine Safety Information Collection and Compliance
The Department of Labor (DOL) is submitting this Mine Safety and Health Administration (MSHA)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.
Learn More💼Department of Labor Information Collection on Coal Mine Dust Sampling
The Department of Labor (DOL) is submitting this Mine Safety and Health Administration (MSHA)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.
Learn More⚕️VA Proposes Reinstatement of Abortion Exclusions in Medical Benefits
The Department of Veterans Affairs (VA) is proposing to reinstate the full exclusion on abortions and abortion counseling from the medical benefits package, which was removed in 2022. Before that time, this exclusion had been firmly in place since the medical benefits package was first established in 1999. VA is also proposing to reinstate the exclusions on abortion and abortion counseling for Civilian Health and Medical Program of the Department of Veterans Affairs (CHAMPVA) that were removed in 2022. We take this action to ensure that VA provides only needed medical services to our nation's heroes and their families.
Learn More📋Regulatory Hearing on FDA Correction for 21 CFR Part 16
The Department of Health and Human Services published a rule correcting errors in 21 CFR Part 16. It reinstates specific provisions concerning the regulation of medical devices and tobacco products, detailing statutory provisions related to their approval, modification, and potential administrative actions. These updates are crucial for ensuring accurate regulatory compliance for affected businesses.
Learn More💼CDC Seeks Comments on Employee Health Data Collection Regulations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA) Special Exposure Cohort Petitions. This information collection project permits respondents to submit petitions to HHS requesting the addition of classes of employees to the Special Exposure Cohort under EEOICPA.
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