Department of Health and Human Services – Federal Register Recent Federal Regulation Documents

Results 1 - 50 of 44,524
Identifying Trading Partners Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability
Document Number: C1-2017-17569
Type: Notice
Date: 2017-08-23
Agency: Food and Drug Administration, Department of Health and Human Services
Determination of Regulatory Review Period for Purposes of Patent Extension; RECUVYRA; Affirmation
Document Number: 2017-17961
Type: Notice
Date: 2017-08-23
Agency: Food and Drug Administration, Department of Health and Human Services
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
Document Number: 2017-17872
Type: Notice
Date: 2017-08-23
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 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
Document Number: 2017-17871
Type: Notice
Date: 2017-08-23
Agency: Food and Drug Administration, Department of Health and Human Services
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
Document Number: 2017-17856
Type: Notice
Date: 2017-08-23
Agency: Food and Drug Administration, Department of Health and Human Services
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
Document Number: 2017-17855
Type: Notice
Date: 2017-08-23
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 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
Document Number: 2017-17842
Type: Notice
Date: 2017-08-23
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.
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
Document Number: 2017-17836
Type: Notice
Date: 2017-08-23
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.
National Institute of Environmental Health Sciences; Notice of Meeting
Document Number: 2017-17796
Type: Notice
Date: 2017-08-23
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-17790
Type: Notice
Date: 2017-08-23
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Meeting
Document Number: 2017-17789
Type: Notice
Date: 2017-08-23
Agency: Department of Health and Human Services, National Institutes of Health
Draft-National Occupational Research Agenda for Manufacturing
Document Number: 2017-17786
Type: Notice
Date: 2017-08-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 http://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
Document Number: 2017-17783
Type: Notice
Date: 2017-08-23
Agency: Food and Drug Administration, Department of Health and Human Services
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
Document Number: 2017-17734
Type: Notice
Date: 2017-08-22
Agency: 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
Document Number: 2017-17726
Type: Notice
Date: 2017-08-22
Agency: Food and Drug Administration, Department of Health and Human Services
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
Document Number: 2017-17708
Type: Notice
Date: 2017-08-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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
Document Number: 2017-17704
Type: Proposed Rule
Date: 2017-08-22
Agency: Food and Drug Administration, Department of Health and Human Services
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
Document Number: 2017-17703
Type: Notice
Date: 2017-08-22
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Exception From General Requirements for Informed Consent
Document Number: 2017-17702
Type: Notice
Date: 2017-08-22
Agency: Food and Drug Administration, Department of Health and Human Services
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
Document Number: 2017-17701
Type: Notice
Date: 2017-08-22
Agency: Food and Drug Administration, Department of Health and Human Services
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
Document Number: 2017-17699
Type: Notice
Date: 2017-08-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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.
Submission for OMB Review; Comment Request
Document Number: 2017-17681
Type: Notice
Date: 2017-08-22
Agency: Department of Health and Human Services, Administration for Children and Families
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2017-17667
Type: Notice
Date: 2017-08-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2017-17666
Type: Notice
Date: 2017-08-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2017-17665
Type: Notice
Date: 2017-08-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2017-17664
Type: Notice
Date: 2017-08-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Meeting
Document Number: 2017-17663
Type: Notice
Date: 2017-08-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Meetings
Document Number: 2017-17662
Type: Notice
Date: 2017-08-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Meeting
Document Number: 2017-17661
Type: Notice
Date: 2017-08-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2017-17660
Type: Notice
Date: 2017-08-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2017-17659
Type: Notice
Date: 2017-08-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2017-17658
Type: Notice
Date: 2017-08-22
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2017-17657
Type: Notice
Date: 2017-08-22
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-17656
Type: Notice
Date: 2017-08-22
Agency: Department of Health and Human Services, National Institutes of Health
340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation
Document Number: 2017-17633
Type: Proposed Rule
Date: 2017-08-21
Agency: Department of Health and Human Services
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
Document Number: 2017-17603
Type: Notice
Date: 2017-08-21
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Division of Behavioral Health; Office of Clinical and Preventive Services; Zero Suicide Initiative-Support
Document Number: 2017-17599
Type: Notice
Date: 2017-08-21
Agency: Department of Health and Human Services, Indian Health Service
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-17582
Type: Notice
Date: 2017-08-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 National Health Interview Survey (NHIS). The annual National Health Interview Survey is a major source of general statistics on the health of the U.S. population.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-17581
Type: Notice
Date: 2017-08-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Identifying Trading Partners Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability
Document Number: 2017-17569
Type: Notice
Date: 2017-08-21
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 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.
Electronic Study Data Submission; Data Standards; Support for Standard for Exchange of Nonclinical Data Implementation Guide Version 3.1
Document Number: 2017-17567
Type: Notice
Date: 2017-08-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is announcing support for the 3.1 version of Clinical Data Interchange Standards Consortium (CDISC) Standard for Exchange of Nonclinical Data (SEND IG 3.1), the end of support for the 3.0 version of SEND IG, and an update to the FDA Data Standards Catalog (Catalog). (See http://www.fda.gov/forindustry/ datastandards/studydatastandards/default.htm.) SEND IG 3.1 has been available from CDISC (www.cdisc.org) since July 2016. FDA is encouraging sponsors and applicants to use SEND IG 3.1 in investigational study data provided in regulatory submissions to CDER.
Determination of Regulatory Review Period for Purposes of Patent Extension; RECUVYRA
Document Number: 2017-17566
Type: Notice
Date: 2017-08-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for RECUVYRA 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 animal drug product.
Medical Device Classification Procedures; Change of Address; Technical Amendment
Document Number: 2017-17564
Type: Rule
Date: 2017-08-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is amending the Medical Device Classification Procedures regulation to reflect a change in address for the Center for Devices and Radiological Health (CDRH). This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.
Content of Risk Information in the Major Statement in Prescription Drug Direct-to-Consumer Broadcast Advertisements; Establishment of a Public Docket; Request for Information and Comments
Document Number: 2017-17563
Type: Notice
Date: 2017-08-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is establishing a public docket to assist with its development of recommendations regarding the communication of risk information in direct-to-consumer (DTC) broadcast advertisements for prescription drugs and biologics.
National Library of Medicine; Notice of Closed Meetings
Document Number: 2017-17542
Type: Notice
Date: 2017-08-21
Agency: Department of Health and Human Services, National Institutes of Health
Charter Renewal of the National Vaccine Advisory Committee
Document Number: 2017-17527
Type: Notice
Date: 2017-08-21
Agency: Department of Health and Human Services
The Department of Health and Human Services is hereby giving notice that the charter for the National Vaccine Advisory Committee (NVAC) has been renewed.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-17519
Type: Notice
Date: 2017-08-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-17518
Type: Notice
Date: 2017-08-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services