Department of Health and Human Services 2018 – Federal Register Recent Federal Regulation Documents

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Agency Information Collection Activities; Proposed Collection; Comment Request; Data Collection Materials for the Annual Performance Reporting of the Administration for Community Living's American Indian, Alaskan Natives and Native Hawaiian Programs
Document Number: 2018-17576
Type: Notice
Date: 2018-08-15
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a 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 Revision of a Currently Approved Collection (ICR Rev) and solicits comments on the information collection requirements related to the annual Program Performance Report (PPR) for the American Indian, Alaskan Natives and Native Hawaiian Programs under Title VI of the Older Americans Act.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2018-17575
Type: Notice
Date: 2018-08-15
Agency: Department of Health and Human Services, Administration for Children and Families
Statement of Organizations, Functions, and Delegations of Authority The Administration for Children and Families (ACF) has realigned the Office of Human Services Emergency Preparedness and Response (OHSEPR). OHSEPR will be a direct report to the Deputy Assistant Secretary for External Affairs. ACF will transfer the U.S. Repatriation Program from the Office of Refugee Resettlement (ORR) to OHSEPR. The OHSEPR mission statement has been revised to include the Repatriation Program and responsibility for business continuity planning. It renames the Division of Disaster Case Management to the Division of Response and Recovery Operations and the Division of Emergency Planning, Policy and Operations to the Division of Emergency Policy and Planning. Lastly, it changes the reporting relationship of the Office of Communications from a direct report to the Deputy Assistant Secretary for External Affairs to a direct report to the Assistant Secretary for Children and Families.
Submission for OMB Review; Comment Request
Document Number: 2018-17563
Type: Notice
Date: 2018-08-15
Agency: Department of Health and Human Services, Administration for Children and Families
Submission for OMB Review; Comment Request
Document Number: 2018-17560
Type: Notice
Date: 2018-08-15
Agency: Department of Health and Human Services, Administration for Children and Families
Announcement of Intent To Issue One OPDIV-Initiated Supplement to BCFS Health and Human Services Under the Standing Announcement for Residential (Shelter) Services for Unaccompanied Children, HHS-2017-ACF-ORR-ZU-1132
Document Number: 2018-17558
Type: Notice
Date: 2018-08-15
Agency: Department of Health and Human Services, Administration for Children and Families
ACF, ORR, announces the intent to issue one OPDIV-Initiated Supplement to BCFS Health and Human Services, San Antonio, TX in the amount of up to $19,011,218. ORR has been identifying additional capacity to provide shelter for potential increases in apprehensions of Unaccompanied Children at the U.S. Southern Border. Planning for increased shelter capacity is a prudent step to ensure that ORR is able to meet its responsibility, by law, to provide shelter for Unaccompanied Alien Children referred to its care by the Department of Homeland Security (DHS). To ensure sufficient capacity to provide shelter to unaccompanied children referred to HHS, BCFS proposed to provide ORR with 700 beds in an expedited manner.
Center for Substance Abuse Treatment; Notice of Meeting
Document Number: 2018-17528
Type: Notice
Date: 2018-08-15
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Issuance of Priority Review Voucher; Rare Pediatric Disease Product
Document Number: 2018-17527
Type: Notice
Date: 2018-08-15
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 approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that CRYSVITA (burosamab-twza), manufactured by Ultragenyx Pharmaceutical, Inc., meets the criteria for a priority review voucher.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application
Document Number: 2018-17526
Type: Notice
Date: 2018-08-15
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, 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 collection of information entitled ``Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application.''
Elemental Impurities in Animal Drug Products-Questions and Answers; Draft Guidance for Industry; Availability; Reopening of the Comment Period
Document Number: 2018-17525
Type: Notice
Date: 2018-08-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is reopening the comment period for the notice of availability that published in the Federal Register on March 27, 2018. In that document, FDA requested comments on the draft guidance for industry (GFI) #255 entitled ``Elemental Impurities in Animal Drug ProductsQuestions and Answers.'' The Agency is taking this action in response to requests for an extension to allow interested parties additional time to develop and submit comments.
Pharmaceutical Science and Clinical Pharmacology Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2018-17524
Type: Notice
Date: 2018-08-15
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 Pharmaceutical Science and Clinical Pharmacology 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.
Medicare and Medicaid Programs: Application From the Joint Commission (TJC) for Continued Approval of its Psychiatric Hospital Accreditation Program
Document Number: 2018-17519
Type: Notice
Date: 2018-08-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed notice acknowledges the receipt of an application from the Joint Commission (TJC) for continued recognition as a national accrediting organization for psychiatric hospitals that wish to participate in the Medicare or Medicaid programs.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2018-17477
Type: Notice
Date: 2018-08-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2018-17474
Type: Notice
Date: 2018-08-15
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2018-17472
Type: Notice
Date: 2018-08-15
Agency: Department of Health and Human Services, National Institutes of Health
Meeting of the Pain Management Best Practices Inter-Agency Task Force
Document Number: 2018-17446
Type: Notice
Date: 2018-08-14
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that a meeting is scheduled to be held for the Pain Management Best Practices Inter-Agency Task Force (Task Force). The meeting will be open to the public; public comment sessions will be held during the meeting.
The Biomedical Advanced Research and Development Authority (BARDA)
Document Number: 2018-17381
Type: Notice
Date: 2018-08-14
Agency: Department of Health and Human Services
The Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR), in the Department of Health and Human Services intends to provide a Single Source Cooperative Agreement to Janssen Research & Development, LLC. The Cooperative Agreement will support QuickFire Challenges to spur innovation in respiratory protection. The total proposed cost of the Single Source Cooperative Agreement is not to exceed $100,000 for a total of 12 months.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Food Safety, Health, and Diet Survey
Document Number: 2018-17363
Type: Notice
Date: 2018-08-14
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study of Risk Information Amount and Location in Direct-to-Consumer Print Ads
Document Number: 2018-17360
Type: Notice
Date: 2018-08-14
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 (the PRA).
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2018-17345
Type: Notice
Date: 2018-08-13
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; 30-Day Comment Request Collection of Customer Service, Demographic, and Smoking/Tobacco Use Information From the National Cancer Institute's Contact Center (CC) Clients (NCI); Correction
Document Number: 2018-17344
Type: Notice
Date: 2018-08-13
Agency: Department of Health and Human Services, National Institutes of Health
The Department of Health and Human Services, National Institutes of Health published a Notice in the Federal Register on July 27, 2018. That Notice inadvertently contained an error in the Estimated Annualized Burden Hours Table.
National Institute of Environmental Health Sciences; Notice of Closed Meetings
Document Number: 2018-17343
Type: Notice
Date: 2018-08-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2018-17342
Type: Notice
Date: 2018-08-13
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2018-17340
Type: Notice
Date: 2018-08-13
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Collection; 60-Day Comment Request; National Cancer Institute (NCI) Future Fellows Resume Databank
Document Number: 2018-17339
Type: Notice
Date: 2018-08-13
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health, National Cancer Institute (NCI) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2018-17318
Type: Notice
Date: 2018-08-13
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.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-April through June 2018
Document Number: 2018-17316
Type: Notice
Date: 2018-08-13
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from April through June 2018, relating to the Medicare and Medicaid programs and other programs administered by CMS.
Authorization of Emergency Use of a Freeze Dried Plasma Treatment for Hemorrhage or Coagulopathy During an Emergency Involving Agents of Military Combat; Availability
Document Number: 2018-17303
Type: Notice
Date: 2018-08-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for a freeze dried plasma treatment for hemorrhage or coagulopathy during an emergency involving agents of military combat (e.g., firearms, projectiles, and explosive devices) when plasma is not available for use or when the use of plasma is not practical. FDA issued this Authorization under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as requested by the U.S. Department of Defense (DoD). The Authorization contains, among other things, conditions on the emergency use of the authorized treatment. The Authorization follows the June 7, 2018, determination by the Deputy Secretary of Defense that there is a military emergency or significant potential for a military emergency, involving a heightened risk to U.S. military forces of an attack with an agent or agents that may cause, or are otherwise associated with an imminently life-threatening and specific risk to those forces. The Deputy Secretary of Defense further stated that, more specifically, U.S. forces are now deployed in multiple locations where they serve at heightened risk of an enemy attack with agents of military combat, including firearms, projectiles, and explosive devices, that may cause major and imminently life-threatening combat casualties involving uncontrolled hemorrhage. On the basis of such determination, the Department of Health and Human Services (HHS) Secretary declared on July 9, 2018, that circumstances exist justifying the authorization of emergency use of freeze dried plasma for the treatment of hemorrhage or coagulopathy during an emergency involving agents of military combat (e.g., firearms, projectiles, and explosive devices) when plasma is not available for use or when the use of plasma is not practical, subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2018-17302
Type: Notice
Date: 2018-08-13
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.
Expansion Cohorts: Use in First-In-Human Clinical Trials To Expedite Development of Oncology Drugs and Biologics; Draft Guidance for Industry; Availability
Document Number: 2018-17273
Type: Notice
Date: 2018-08-13
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 ``Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics.'' The purpose of this draft guidance is to provide advice to sponsors regarding the design and conduct of first-in-human (FIH) clinical trials intended to efficiently expedite the clinical development of cancer drugs, including biological products, through multiple expansion cohort study designs.
Patient-Focused Drug Development Guidance: Methods To Identify What Is Important to Patients and Select, Develop, or Modify Fit-for-Purpose Clinical Outcome Assessments; Public Workshop; Request for Comments
Document Number: 2018-17272
Type: Notice
Date: 2018-08-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a 2-day public workshop to convene a discussion on methodological approaches that may be used to identify what is most important to patients and caregivers with respect to burden of disease, burden of treatment, and the benefits and risks in the management of the patient's disease, and best practices for selecting, developing, or modifying fit-for-purpose clinical outcome assessments (COAs) to measure the patient experience in clinical trials. This workshop will inform development of patient- focused drug development guidance as required by the 21st Century Cures Act (Cures Act) and as part of commitments made by FDA under the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI). FDA will publish discussion documents approximately 1 month before the workshop date. FDA is interested in seeking information and comments on the approaches proposed in the discussion documents. FDA is also interested in input on examples, which could be illustrated in the draft guidance, where the approaches proposed in the discussion document have been successfully applied.
Fougera Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 20 Abbreviated New Drug Applications
Document Number: 2018-17226
Type: Notice
Date: 2018-08-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 20 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2018-17190
Type: Notice
Date: 2018-08-10
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.
HHS Approval of Entities That Certify Medical Review Officers
Document Number: 2018-17184
Type: Notice
Date: 2018-08-10
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
This notice publishes a list of the Department of Health and Human Services (HHS) approved Medical Review Officers certification entities. The HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines), applicable on October 1, 2017, addresses the role and qualifications of Medical Review Officers (MROs) and HHS approval of entities that certify MROs.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-17176
Type: Notice
Date: 2018-08-10
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 the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled FoodNet Population Survey. The FoodNet Population Survey is conducted in 10 states and collects data on the prevalence of acute gastrointestinal illness in the United States and exposures associated with foodborne illness.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-17175
Type: Notice
Date: 2018-08-10
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 the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled the National Ambulatory Medical Care Survey (NAMCS). The goal of the project is to assess the health of the population through patient use of physician offices, community health centers (CHCs), and to monitor the characteristics of physician practices].
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-17174
Type: Notice
Date: 2018-08-10
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 the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Dental Survey: Improving outpatient antibiotic use through implementation and evaluation of Core Elements of Outpatient Antibiotic Stewardship.'' This information collection request will generate data to assess knowledge, attitudes, practices and perceived barriers to appropriate antibiotic prescribing in a representative sample of dental providers. Results will be used to inform interventions for this specific provider population and support our efforts to improve antimicrobial stewardship within outpatient clinics.
Submission for OMB Review; Comment Request
Document Number: 2018-17152
Type: Notice
Date: 2018-08-10
Agency: Department of Health and Human Services, Administration for Children and Families
Patient Protection and Affordable Care Act; Adoption of the Methodology for the HHS-Operated Permanent Risk Adjustment Program for the 2018 Benefit Year Proposed Rule
Document Number: 2018-17142
Type: Proposed Rule
Date: 2018-08-10
Agency: Department of Health and Human Services
This rule proposes to adopt the risk adjustment methodology that HHS previously established for the 2018 benefit year. In February 2018, a district court vacated the use of statewide average premium in the HHS-operated risk adjustment methodology for the 2014 through 2018 benefit years. HHS is proposing to adopt the HHS-operated risk adjustment methodology for the 2018 benefit year as established in the final rules published in the March 23, 2012 Federal Register and the December 22, 2016 Federal Register.
Human Dermal (Skin) Safety Testing for Topical Drug Products: Regulatory Utility and Evaluation; Public Workshop; Request for Comments
Document Number: 2018-17130
Type: Notice
Date: 2018-08-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is announcing the following 1-day public workshop entitled ``Human Dermal (Skin) Safety Testing for Topical Drug Products: Regulatory Utility and Evaluation.'' The purpose of the public workshop is to provide a forum to discuss the current state and future directions of the collection of human data on the potential skin toxicity with the use of medications applied topically. The workshop will review current approaches to the collection of human data during the clinical development of topical drug products. The workshop will also address the impact of human skin toxicity studies on drug labeling and consider alternative approaches to providing information about skin toxicity.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-17127
Type: Notice
Date: 2018-08-10
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-17126
Type: Notice
Date: 2018-08-10
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Submission for OMB Review; Comment Request
Document Number: 2018-17121
Type: Notice
Date: 2018-08-10
Agency: Department of Health and Human Services, Administration for Children and Families
Chronic Pain: The Science of Complementary and Integrative Health Approaches
Document Number: 2018-17118
Type: Notice
Date: 2018-08-10
Agency: Department of Health and Human Services, National Institutes of Health
This symposium on September 11, 2018, sponsored by the National Center for Complementary and Integrative Health, will bring leading researchers to discuss the science and potential uses of complementary and integrative health approaches in treating chronic pain.
National Institute on Alcohol Abuse and Alcoholism; Notice of Meeting
Document Number: 2018-17107
Type: Notice
Date: 2018-08-10
Agency: Department of Health and Human Services
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2018-17105
Type: Notice
Date: 2018-08-10
Agency: Department of Health and Human Services
National Cancer Institute Amended; Notice of Meeting
Document Number: 2018-17104
Type: Notice
Date: 2018-08-10
Agency: Department of Health and Human Services
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-17103
Type: Notice
Date: 2018-08-10
Agency: Department of Health and Human Services, National Institutes of Health