Department of Health and Human Services March 2017 – Federal Register Recent Federal Regulation Documents

Results 201 - 250 of 265
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2017-04490
Type: Notice
Date: 2017-03-08
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2017-04489
Type: Notice
Date: 2017-03-08
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2017-04488
Type: Notice
Date: 2017-03-08
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2017-04487
Type: Notice
Date: 2017-03-08
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2017-04485
Type: Notice
Date: 2017-03-08
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-04484
Type: Notice
Date: 2017-03-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2017-04483
Type: Notice
Date: 2017-03-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental and Craniofacial Research; Notice of Closed Meeting
Document Number: 2017-04482
Type: Notice
Date: 2017-03-08
Agency: Department of Health and Human Services, National Institutes of Health
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2017-04354
Type: Notice
Date: 2017-03-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2017-04326
Type: Notice
Date: 2017-03-07
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary and Integrative Health; Notice of Closed Meeting
Document Number: 2017-04325
Type: Notice
Date: 2017-03-07
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2017-04324
Type: Notice
Date: 2017-03-07
Agency: Department of Health and Human Services, National Institutes of Health
Health Risks to Workers Associated With Occupational Exposures to Peracetic Acid; Request for Information
Document Number: 2017-04319
Type: Notice
Date: 2017-03-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention intends to evaluate the scientific and technical data on occupational exposures to peracetic acid (CAS #79-21-0, also known as peroxyacetic acid and PAA). NIOSH is requesting information on the following: (1) Workplace exposure data for peracetic acid, (2) possible health effects observed in workers exposed to peracetic acid, (3) workplaces and products in which peracetic acid may be found, (4) description of work tasks and scenarios with a potential for exposure to peracetic acid, (5) reports and findings from in vitro and in vivo toxicity studies with peracetic acid, (6) data applicable to the quantitative risk assessment of health effects associated with acute, subchronic and chronic workplace exposures to peracetic acid, (7) sampling and analytical methods for peracetic acid, and (8) control measures, including engineering controls, work practices, and personal protective equipment (PPE), that are being used in workplaces where there is potential for exposure to peracetic acid.
340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties; Delay of Effective Date
Document Number: 2017-04337
Type: Rule
Date: 2017-03-06
Agency: Department of Health and Human Services
In accordance with the memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled ``Regulatory Freeze Pending Review,'' this action temporarily delays for 60 days from the date of the memorandum the effective date of the final rule titled ``340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation,'' published in the January 5, 2017, Federal Register. This document announces that the effective date is delayed until March 21, 2017.
Medicaid and Children's Health Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP Delivered in Managed Care, and Revisions Related to Third Party Liability; Corrections
Document Number: 2017-04307
Type: Rule
Date: 2017-03-06
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical errors that appeared in the correcting amendment published in the January 3, 2017 Federal Register (82 FR 37 through 40) entitled, ``Medicaid and Children's Health Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP Delivered in Managed Care, and Revisions Related to Third Party Liability; Corrections.''
Submission for OMB Review; 30-Day Comment Request; NCI Genomic Data Commons (GDC) Data Submission Request Form (National Cancer Institute)
Document Number: 2017-04255
Type: Notice
Date: 2017-03-06
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on Tuesday, November 8, 2016 page 78609 Vol. 81 No. 216 FR 78609 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Submission for OMB Review; 30-Day Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery, (National Cancer Institute)
Document Number: 2017-04254
Type: Notice
Date: 2017-03-06
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on December 13, 2016 page 89954 (81 FR (89954) and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Submission for OMB Review; 30-Day Comment Request; CTEP Support Contracts Forms and Surveys, NCI, NIH
Document Number: 2017-04253
Type: Notice
Date: 2017-03-06
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2017-04249
Type: Notice
Date: 2017-03-06
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for extending the use of the approved information collection assigned OMB control number 0990-0278, which expires on August 31, 2017. Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Determination That FLONASE (Fluticasone Propionate) Nasal Spray, 0.05 Milligram, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2017-04231
Type: Notice
Date: 2017-03-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that prescription FLONASE (fluticasone propionate) Nasal Spray, 0.05 milligram (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and this determination will allow FDA to continue to approve ANDAs for fluticasone propionate nasal spray, 0.05 mg, if all other legal and regulatory requirements are met.
Public Meeting on Patient-Focused Drug Development for Autism; Request for Comments
Document Number: 2017-04229
Type: Notice
Date: 2017-03-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting and an opportunity for public comment on Patient-Focused Drug Development for autism. Patient-Focused Drug Development is part of FDA's performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patient perspectives on the impact of autism on daily life as well as patient views on treatment approaches for autism.
Issuance of Priority Review Voucher; Rare Pediatric Disease Product
Document Number: 2017-04228
Type: Notice
Date: 2017-03-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. FDA has determined that SPINRAZA (nusinersen), manufactured by Biogen Inc., meets the criteria for a priority review voucher.
Supplemental Evidence and Data Request on Effects of Dietary Sodium and Potassium Intake on Chronic Disease Outcomes and Related Risk Factors
Document Number: 2017-04193
Type: Notice
Date: 2017-03-06
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review of Effects of Dietary Sodium and Potassium Intake on Chronic Disease Outcomes and Related Risk Factors, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review. AHRQ is conducting this systematic review pursuant to Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a).
DSM Biomedical; Filing of Color Additive Petition
Document Number: 2017-04188
Type: Proposed Rule
Date: 2017-03-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by DSM Biomedical, proposing that the color additive regulations be amended to provide for the safe use of high purity carbon black for coloring ultra-high molecular weight polyethylene sutures for use in general surgery.
National Center for Complementary & Integrative Health; Notice of Closed Meeting
Document Number: 2017-04177
Type: Notice
Date: 2017-03-06
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Closed Meeting
Document Number: 2017-04176
Type: Notice
Date: 2017-03-06
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2017-04175
Type: Notice
Date: 2017-03-06
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Amended Notice of Meeting
Document Number: 2017-04174
Type: Notice
Date: 2017-03-06
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2017-04173
Type: Notice
Date: 2017-03-06
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-04172
Type: Notice
Date: 2017-03-06
Agency: Department of Health and Human Services, National Institutes of Health
Meeting of the 2018 Physical Activity Guidelines Advisory Committee
Document Number: 2017-04170
Type: Notice
Date: 2017-03-06
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act (FACA), the U.S. Department of Health and Human Services (HHS) is hereby giving notice that the third meeting of the 2018 Physical Activity Guidelines Advisory Committee (2018 PAGAC or Committee) will be held. This meeting will be open to the public via videocast.
Agency Information Collection Activities; Proposed Collection; Public Comment Request; Extension of a Currently Approved Information Collection (ICR-REV); Centers for Independent Living Annual Performance Report (CILPPR); Correction
Document Number: 2017-04169
Type: Notice
Date: 2017-03-06
Agency: Department of Health and Human Services
The Administration for Community Living published a proposed collection of information document in the Federal Register on February 23, 2017. (82 FR 11471 and 11472) The document contained an incorrect date and email address. In addition under the heading ``New Requirements'', the first paragraph was revised.
Joint Meeting of the Nonprescription Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2017-04152
Type: Notice
Date: 2017-03-03
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 Nonprescription Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees 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.
Request for Nominations of Candidates To Serve on the Clinical Laboratory Improvement Advisory Committee (CLIAC)
Document Number: 2017-04103
Type: Notice
Date: 2017-03-03
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2017-04102
Type: Notice
Date: 2017-03-03
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Board on Radiation and Worker Health (ABRWH or Advisory Board), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2017-04101
Type: Notice
Date: 2017-03-03
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2017-04082
Type: Notice
Date: 2017-03-03
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2017-04078
Type: Notice
Date: 2017-03-03
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2017-04077
Type: Notice
Date: 2017-03-03
Agency: Department of Health and Human Services
National Cancer Institute; Amended Notice of Meeting
Document Number: 2017-04076
Type: Notice
Date: 2017-03-03
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Amended Notice of Meeting
Document Number: 2017-04075
Type: Notice
Date: 2017-03-03
Agency: Department of Health and Human Services
National Cancer Institute; Amended Notice of Meeting
Document Number: 2017-04074
Type: Notice
Date: 2017-03-03
Agency: Department of Health and Human Services
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-04073
Type: Notice
Date: 2017-03-03
Agency: Department of Health and Human Services, National Institutes of Health
Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB)
Document Number: 2017-04160
Type: Notice
Date: 2017-03-02
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare and Medicaid Services (CMS) is requesting that an information collection request (ICR) related to the Medicare and Medicaid Programs: Conditions of Participation for Home Health Agencies (HHAs) and Supporting Regulations at 42 CFR part 484, be processed under the emergency clearance process associated with 5 CFR 1320.13(a)(2)(i). Public harm is reasonably likely to ensue if the normal, non-emergency clearance procedures are followed. The approval of this information collection package is necessary because in the absence of such approval CMS will be unable to effectively enforce these essential health and safety requirements. Among other things, CMS will be unable to enforce requirements that HHAs must provide a notice of rights to each patient, assure the proper training of home health aides before those aides provide hands-on care to patients, and disclose the names and addresses of all individuals with an ownership or management position so that we can assure that those with a history of fraud are not involved in HHA operations. Being unable to enforce these rules would harm patient health and safety, as well as create risks to the integrity of the Medicare and Medicaid programs. Under the PRA, federal agencies are required to publish notice in the Federal Register concerning each proposed ICR. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this ICR including the necessity and utility of the proposed ICR 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.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-04047
Type: Notice
Date: 2017-03-02
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 comment on the proposed information collection request revision to the project titled ``Pulmonary Function Testing Course Approval Program.'' Potential sponsors (university, hospital, and private consulting firms) apply to this program to receive NIOSH-approval to conduct training courses that teach technicians to perform spirometry as specified under the Occupational Safety and Health Administration's Cotton Dust Standard, 29 CFR 1020.1043.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-04046
Type: Notice
Date: 2017-03-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-04045
Type: Notice
Date: 2017-03-02
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 comment on a proposed information collection project titled ``Factors Influencing the Transmission of Influenza.'' This data collection project will help examine the amount of influenza virus in airborne particles produced by subjects with influenza and it relationship to biomarkers in the blood.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-04044
Type: Notice
Date: 2017-03-02
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 comment on the proposed information collection project titled ``Assessing the Infrastructure for Public Sexually Transmitted Disease (STD) Prevention Services.'' The primary goal of this study is to periodically monitor (i.e., every 3 years) STD preventive and treatment services provided by local and state health departments. This will allow CDC to understand the delivery of timely public STD preventive and treatment services to reduce the number of newly acquired STDs and prevent STD-related sequelae.