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

Results 301 - 350 of 26,867
Submission for OMB Review; Comment Request; Child Care Development Fund (CCDF)-Reporting Improper Payments-Instructions for States
Document Number: 2018-14705
Type: Notice
Date: 2018-07-10
Agency: Department of Health and Human Services, Administration for Children and Families
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2018-14648
Type: Notice
Date: 2018-07-09
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-14647
Type: Notice
Date: 2018-07-09
Agency: Department of Health and Human Services, National Institutes of Health
Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components; Guidance for Industry; Availability
Document Number: 2018-14537
Type: Notice
Date: 2018-07-09
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 final guidance for industry entitled ``Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components; Guidance for Industry.'' The guidance document provides blood establishments that collect Whole Blood and blood components with revised recommendations to reduce the risk of transmission of Zika virus (ZIKV) by blood and blood components. The guidance does not apply to the collection of Source Plasma. The guidance announced in this notice supersedes the document of the same title dated August 2016 (August 2016 Guidance).
Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products-Content and Format; Draft Guidance for Industry; Availability
Document Number: 2018-14535
Type: Notice
Date: 2018-07-09
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Indications and Usage Section of Labeling for Human Prescription Drug and Biological ProductsContent and Format.'' This guidance is intended to assist applicants in writing the Indications and Usage section of labeling. The recommendations in this draft guidance are intended to help ensure that the labeling is clear, concise, useful, and informative and, to the extent possible, consistent in content and format within and across drug and therapeutic classes.
Medicaid Program; Final FY 2016 and Preliminary FY 2018 Disproportionate Share Hospital Allotments, and Final FY 2016 and Preliminary FY 2018 Institutions for Mental Diseases Disproportionate Share Hospital Limits
Document Number: 2018-14533
Type: Notice
Date: 2018-07-06
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the final federal share disproportionate share hospital (DSH) allotments for federal fiscal year (FY) 2016 and the preliminary federal share DSH allotments for FY 2018. This notice also announces the final FY 2016 and the preliminary FY 2018 limitations on aggregate DSH payments that states may make to institutions for mental disease and other mental health facilities. In addition, this notice includes background information describing the methodology for determining the amounts of states' FY DSH allotments.
Notice of Closed Meeting
Document Number: 2018-14492
Type: Notice
Date: 2018-07-06
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Submission for OMB Review; 30-Day Comment Request; NIH NeuroBioBank Tissue Access Request Form, (National Institute of Mental Health)
Document Number: 2018-14490
Type: Notice
Date: 2018-07-06
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.
Submission for OMB Review; Comment Request
Document Number: 2018-14486
Type: Notice
Date: 2018-07-06
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: 2018-14456
Type: Notice
Date: 2018-07-06
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2018-14455
Type: Notice
Date: 2018-07-06
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: 2018-14454
Type: Notice
Date: 2018-07-06
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2018-14453
Type: Notice
Date: 2018-07-06
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; 30-Day Comment Request; The Genetic Testing Registry
Document Number: 2018-14435
Type: Notice
Date: 2018-07-05
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.
Abbreviated New Drug Application Submissions-Amendments to Abbreviated New Drug Applications Under the Generic Drug User Fee Act; Guidance for Industry; Availability
Document Number: 2018-14429
Type: Notice
Date: 2018-07-05
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 final guidance for industry entitled ``ANDA SubmissionsAmendments to Abbreviated New Drug Applications Under GDUFA.'' This guidance finalizes the October 2017 draft guidance for industry ``ANDA SubmissionsAmendments to Abbreviated New Drug Applications Under GDUFA.'' This guidance is intended to explain to applicants how the review goals established as part of the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II) apply to amendments to either abbreviated new drug applications (ANDAs) or prior approval supplements (PASs) submitted to FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance describes amendment classifications and categories and explains how amendment submissions may affect an application's review goal dates. The guidance also describes how FDA will review amendments submitted to ANDAs and PASs received prior to October 1, 2017, the effective date to implement the GDUFA II review goals.
Office of Direct Service and Contracting Tribes; Tribal Management Grant Program
Document Number: 2018-14426
Type: Notice
Date: 2018-07-05
Agency: Department of Health and Human Services, Indian Health Service
Center for Mental Health Services; Notice of Meeting
Document Number: 2018-14381
Type: Notice
Date: 2018-07-05
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Advisory Council on Alzheimer's Research, Care, and Services; Meeting
Document Number: 2018-14376
Type: Notice
Date: 2018-07-05
Agency: Department of Health and Human Services
This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Advisory Council on Alzheimer's Research, Care, and Services provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. The Advisory Council will spend the majority of the July meeting considering recommendations made by each of the three subcommittees to present to the Secretary of HHS and Congress. Additional presentations in the afternoon will include a presentation on a recent study by RAND on the health care infrastructure, the CDC/ Alzheimer's Association's joint Healthy Brain Initiative Roadmap, federal workgroup updates, and updates on work by the non-federal members.
Statement of Organizations, Functions, and Delegations of Authority
Document Number: 2018-14375
Type: Notice
Date: 2018-07-05
Agency: Food and Drug Administration, Department of Health and Human Services
Statement of Organizations, Functions, and Delegations of Authority. The Food and Drug Administration (FDA) is announcing that it has reorganized the Office of Foods and Veterinary Medicine (OFVM), Center for Food Safety and Applied Nutrition (CFSAN) by establishing the new Office of Executive Programs (OEP); realigning OFVM's Office of Coordinated Outbreak Response and Evaluation (CORE) Network along with its Prevention Staff and Response Staff under CFSAN; and retitling the Office of Regulations, Policy, and Social Science (ORPSS) to the Office of Regulations and Policy (ORP). With the retitling to ORP, the Regulations and Special Government Employee Management Staff was retitled to the Regulations Development Staff, and the Government Information Staff was established. This reorganization resulted in the abolishment of OFVM's Executive Secretariat Staff, CFSAN's Office of the Center Director's (OCD) Executive Operations Staff, and the Division of Social Sciences under the former ORPSS. This new organizational structure was approved by the Acting Secretary of Health and Human Services and applicable on December 7, 2017.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-14336
Type: Notice
Date: 2018-07-03
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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.
Office of the Director Notice of Charter Renewal
Document Number: 2018-14318
Type: Notice
Date: 2018-07-03
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Meeting
Document Number: 2018-14317
Type: Notice
Date: 2018-07-03
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse And Alcoholism; Notice of Closed Meeting
Document Number: 2018-14316
Type: Notice
Date: 2018-07-03
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-14315
Type: Notice
Date: 2018-07-03
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-14314
Type: Notice
Date: 2018-07-03
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-14313
Type: Notice
Date: 2018-07-03
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2018-14311
Type: Notice
Date: 2018-07-03
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-14310
Type: Notice
Date: 2018-07-03
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-14309
Type: Notice
Date: 2018-07-03
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations Under the Federal Import Milk Act
Document Number: 2018-14266
Type: Notice
Date: 2018-07-03
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 (PRA).
Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions; Section 351(k) Biosimilar Applications
Document Number: 2018-14265
Type: Notice
Date: 2018-07-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection in an application for a proposed biosimilar product and an application for a supplement for a proposed interchangeable product.
Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2018-14240
Type: Notice
Date: 2018-07-03
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 Antimicrobial Drugs Advisory Committee. The general function of the committee 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.
Final National Occupational Research Agenda for Services
Document Number: 2018-14227
Type: Notice
Date: 2018-07-03
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
NIOSH announces the availability of the final National Occupational Research Agenda for Services.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2018-14218
Type: Notice
Date: 2018-07-03
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meetings
Document Number: 2018-14217
Type: Notice
Date: 2018-07-03
Agency: Department of Health and Human Services
National Eye Institute; Notice of Closed Meetings
Document Number: 2018-14216
Type: Notice
Date: 2018-07-03
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2018-14215
Type: Notice
Date: 2018-07-03
Agency: Department of Health and Human Services, National Institutes of Health
Center For Scientific Review; Notice of Closed Meetings
Document Number: 2018-14214
Type: Notice
Date: 2018-07-03
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-14213
Type: Notice
Date: 2018-07-03
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Request; 60-Day Public Comment Request
Document Number: 2018-14203
Type: Notice
Date: 2018-07-02
Agency: Department of Health and Human Services
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-14172
Type: Notice
Date: 2018-07-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2018-14165
Type: Notice
Date: 2018-07-02
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities; Proposed Collection; Comment Request; Survey of Current Manufacturing Practices for the Cosmetics Industry
Document Number: 2018-14158
Type: Notice
Date: 2018-07-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a new information collection: A survey of the cosmetics industry on their current manufacturing practices.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
Document Number: 2018-14143
Type: Notice
Date: 2018-07-02
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the internet at http:// www.samhsa.gov/workplace.
Lists of Designated Primary Medical Care, Mental Health, and Dental Health Professional Shortage Areas
Document Number: 2018-14115
Type: Notice
Date: 2018-07-02
Agency: Department of Health and Human Services, Health Resources and Services Administration
This notice informs the public of the availability of the complete lists of all geographic areas, population groups, and facilities designated as primary medical care, mental health, and dental health professional shortage areas (HPSAs) as of May 1, 2018. The lists are available on HRSA's HPSAFind website.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2018-14099
Type: Notice
Date: 2018-06-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Antimicrobial Animal Drug Sales and Distribution Reporting; Small Entity Compliance Guide; Availability
Document Number: 2018-14085
Type: Rule
Date: 2018-06-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry #252 entitled ``Antimicrobial Animal Drug Sales and Distribution Reporting Small Entity Compliance Guide.'' The small entity compliance guide (SECG) is intended to help small entities comply with the final rule we issued in the Federal Register of May 11, 2016, entitled ``Antimicrobial Animal Drug Sales and Distribution Reporting.''
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2018-14077
Type: Notice
Date: 2018-06-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Food Labeling; Declaration of Certifiable Color Additives
Document Number: 2018-14059
Type: Notice
Date: 2018-06-29
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; Administrative Practices and Procedures; Formal Evidentiary Public Hearing
Document Number: 2018-14058
Type: Notice
Date: 2018-06-29
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.