Department of Health and Human Services August 2017 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 249
Mitigation Strategies To Protect Food Against Intentional Adulteration: What You Need To Know About the Food and Drug Administration Regulation: Small Entity Compliance Guide; Availability
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled ``Mitigation Strategies to Protect Food Against Intentional Adulteration: What You Need To Know About the FDA Regulation: Small Entity Compliance Guide.'' The small entity compliance guide (SECG) is intended to help small entities comply with the final rule entitled ``Mitigation Strategies to Protect Food Against Intentional Adulteration.''
Agency Information Collection Activities: Submission to OMB for Review and Approval: Public Comment Request; Information Collection Request Title: Federal Tort Claims Act (FTCA) Program Deeming Applications for Health Center Volunteer Health Professionals, OMB No. 0906-XXXX, New
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Identifying Trading Partners Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Identifying Trading Partners Under the Drug Supply Chain Security Act'' (draft trading partner guidance). FDA is issuing this guidance to assist industry and State and local governments in understanding how to categorize the entities in the drug supply chain in accordance with the Drug Supply Chain Security Act (DSCSA). This guidance explains how to determine when certain statutory requirements will apply to entities that may be considered trading partners in the drug supply chain. FDA is also soliciting public input specific to the activities of ``private-label distributors'' of drug products and whether those activities fall within the definitions under DSCSA of the various trading partners.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Notice of Supplemental Awards to the Territorial Health Departments of Puerto Rico, American Samoa, and U.S. Virgin Islands for the Zika Maternal and Child Health Services Program
HRSA announces the award of supplemental grants under the Zika Response and Preparedness Act to the territorial health departments of Puerto Rico, American Samoa, and U.S. Virgin Islands to address the unmet needs of women, children, and families who are or may be affected by Zika virus (ZIKV) infection.
Regulatory Agenda
The Regulatory Flexibility Act of 1980 and Executive Order (EO) 12866 require the semiannual issuance of an inventory of rulemaking actions under development throughout the Department, offering for public review summarized information about forthcoming regulatory actions.
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach To Establish an Acute Reference Dose; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry (GFI) #232 entitled ``Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish an Acute Reference Dose'' (VICH GL54). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is intended to address the nature and types of data that can be useful in determining a toxicological acute reference dose (ARfD) for residues of veterinary drugs, the studies that may generate such data, and how the ARfD may be calculated based on these data.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Peripheral and Central Nervous System 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 Peripheral and Central Nervous System Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Oncology Drugs for Companion Animals; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry #237 entitled ``Oncology Drugs for Companion Animals.'' The guidance provides recommendations for sponsors of investigational oncology drugs for use in companion animals (e.g., dogs, cats, and horses), discusses the contents of a new animal drug application for certain oncology drugs, and provides recommendations on how to address human user safety concerns.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Submission Process for Voluntary Allegations to the Center for Devices and Radiological Health
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.
Draft-National Occupational Research Agenda for Manufacturing
As steward of the National Occupational Research Agenda (NORA), the National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention announces the availability of the draft National Occupational Research Agenda for Manufacturing for public comment. Written by the NORA Manufacturing Sector Council, the Agenda identifies the most important occupational safety and health research needs for the next decade, 2016-2026. A copy of the draft Agenda is available at https://www.regulations.gov (search Docket Number CDC-2017-0072).
Advancing the Development of Pediatric Therapeutics: Application of “Big Data” to Pediatric Safety Studies; Public Workshop
The Office of Pediatric Therapeutics, Food and Drug Administration (FDA), is announcing a public workshop entitled ``Advancing the Development of Pediatric Therapeutics (ADEPT): Application of ``Big Data'' to Pediatric Safety Studies.'' The purpose of this 2-day workshop is to understand how to access and analyze ``Big Data'' associated with safety information in the health care setting, and the utility and challenges associated with the use of ``Big Data'' to study the safety of therapeutics in children.
Secretarial Review and Publication of the National Quality Forum Report of 2016 Activities to Congress and the Secretary of the Department of Health and Human Services
This notice acknowledges that in accordance with section 1890(b)(5)(B) of the Social Security Act (the Act) the Secretary of the Department of Health and Human Services (the Secretary) has received and reviewed the National Quality Forum (NQF) Report of 2016 Activities to Congress and the Secretary of the Department of Health and Human Services submitted by the consensus-based entity with whom the Secretary has a contract under section 1890(a) of the Act. The purpose of this Federal Register notice is to publish the report, together with the Secretary's comments on such report.
Pediatric Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA or the Agency) announces a forthcoming public advisory committee meeting of the Pediatric Advisory Committee (PAC). The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comments.
Proposed Data Collections Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, 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. This notice invites comments on the information collection extension request titled ``Adverse Events among Persons on Treatment of Latent Tuberculosis Infection.''
Juice Products Association; Filing of Food Additive Petition; Correction
The Food and Drug Administration (FDA or we) is correcting a notice that appeared in the Federal Register of Wednesday, July 26, 2017 (82 FR 34615). The document announced that we have filed a petition, submitted by the Juice Products Association, proposing that the food additive regulations be amended to replace the current Recommended Daily Intake (RDI) percentage values of calcium in fruit juices and fruit juice drinks in the regulation for vitamin D3 with absolute values and to update the specifications for vitamin D3. The document was published with incorrect information on the absolute level of added calcium for fruit juice drinks that are fortified with calcium. This document corrects that error.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling), Submission of Information to a Master File in Support of Petitions; and Electronic Submission Using Food and Drug Administration Form 3503
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Exception From General Requirements for Informed Consent
The Food and Drug Administration (FDA or the Agency) 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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Cosmetic Registration Program
The Food and Drug Administration (FDA, Agency, or we) 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 (PRA).
Proposed Data Collection Submitted for Public Comment and Recommendations
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 to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the Medical Monitoring Project, which collects interview and medical record data on a probability sample of HIV-diagnosed persons in order to provide national estimates of access to and utilization of HIV-related medical care and services, the quality of HIV-related ambulatory care, and HIV- related behaviors and clinical outcomes.
340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation
The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), which is referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' HHS is soliciting comments on delaying the effective date of the January 5, 2017 final rule that sets forth the calculation of the ceiling price and application of civil monetary penalties, and applies to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. HHS proposes to delay the effective date of the final rule published in the Federal Register (82 FR 1210, January 5, 2017) to July 1, 2018. HHS proposes this action in order to allow a more deliberate process of considering alternative and supplemental regulatory provisions and to allow for sufficient time for additional rulemaking, as set forth below.
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 047
The Food and Drug Administration (FDA or Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 047'' (Recognition List Number: 047), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
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