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

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Medicare and Medicaid Program; Application From DNV GL-Healthcare (DNV GL) for Continued Approval of Its Hospital Accreditation Program
Document Number: 2018-17815
Type: Notice
Date: 2018-08-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final notice announces our decision to approve the DNV GL Healthcare for continued recognition as a national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs.
Process To Request a Review of Food and Drug Administration's Decision Not To Issue Certain Export Certificates for Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2018-17796
Type: Notice
Date: 2018-08-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices; Draft Guidance for Industry and Food and Drug Administration Staff.'' FDA is issuing this draft guidance to comply with changes to the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the FDA Reauthorization Act of 2017 (FDARA), to specify the process afforded to persons denied a Certificate to Foreign Government (CFG) for a device. This draft guidance describes the information that the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) will provide to a person whose request for a CFG for a device is denied, and the process for seeking review of such a denial. This draft guidance is not final nor is it in effect at this time.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Controlled Correspondence Related to Generic Drug Development
Document Number: 2018-17787
Type: Notice
Date: 2018-08-17
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.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-17785
Type: Notice
Date: 2018-08-17
Agency: Department of Health and Human Services, National Institutes of Health
Quality Metrics Site Visit Program for Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Staff; Information Available to Industry; Extension of the Proposal Period
Document Number: 2018-17783
Type: Notice
Date: 2018-08-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is extending the proposal period for the ``Quality Metrics Site Visit Program for Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Staff,'' published in the Federal Register of June 29, 2018. FDA is extending the proposal period to allow interested persons additional time to submit an electronic or written proposal.
Draft Report on Carcinogens Monograph on Night Shift Work and Light at Night; Availability of Document; Request for Comments; Notice of Peer-Review Meeting
Document Number: 2018-17782
Type: Notice
Date: 2018-08-17
Agency: Department of Health and Human Services, National Institutes of Health
The National Toxicology Program (NTP) announces a meeting to peer review the Draft Report on Carcinogens Monograph on Night Shift Work and Light at Night. NTP has conducted a literature-based assessment to determine whether night shift work (e.g., working at least three hours between 12 a.m. and 6 a.m.) and light at night are cancer hazards and should be listed the Report on Carcinogens. The peer-review meeting will be held at the National Institute of Environmental Health Sciences (NIEHS) in Research Triangle Park, NC and is open to the public. Registration is requested for attendance at the meeting either in-person or by webcast and to present oral comments. Information about the meeting and registration is available at https://ntp.niehs.nih.gov/go/36051.
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2018-17780
Type: Notice
Date: 2018-08-17
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Comment Request
Document Number: 2018-17777
Type: Notice
Date: 2018-08-17
Agency: Department of Health and Human Services, Administration for Children and Families
Medical Devices and Device-Led Combination Products; Voluntary Malfunction Summary Reporting Program for Manufacturers
Document Number: 2018-17770
Type: Rule
Date: 2018-08-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA, Agency, or we) Center for Devices and Radiological Health and Center for Biologics Evaluation and Research are announcing that the Agency is granting an alternative that permits manufacturer reporting of certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis. We refer to this alternative as the ``Voluntary Malfunction Summary Reporting Program.'' This voluntary program reflects goals for streamlining malfunction reporting outlined in the commitment letter agreed to by FDA and industry and submitted to Congress, as referenced in the Medical Device User Fee Amendments of 2017 (MDUFA IV Commitment Letter).
Proposed Information Collection Activity; Comment Request
Document Number: 2018-17768
Type: Notice
Date: 2018-08-17
Agency: Department of Health and Human Services, Administration for Children and Families
National Institutes of Health (NIH) Office of Science Policy (OSP) Recombinant or Synthetic Nucleic Acid Research: Proposed Changes to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)
Document Number: 2018-17760
Type: Notice
Date: 2018-08-17
Agency: Department of Health and Human Services, National Institutes of Health
The National Institutes of Health (NIH) seeks public comment on its proposal to amend the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) to streamline oversight for human gene transfer clinical research protocols and reduce duplicative reporting requirements already captured within the existing regulatory framework. Specifically, NIH proposes amendments to: Delete the NIH protocol registration submission and reporting requirements under Appendix M of the NIH Guidelines, and modify the roles and responsibilities of entities that involve human gene transfer or the Recombinant DNA Advisory Committee (RAC).
Request for Information To Solicit Feedback on the Brain Research Through Advancing Innovative Neurotechnologies (BRAIN) Initiative
Document Number: 2018-17759
Type: Notice
Date: 2018-08-17
Agency: Department of Health and Human Services, National Institutes of Health
The purpose of this Request for Information (RFI) is to solicit input on how best to accomplish the ambitious vision for the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative[supreg] set forth in BRAIN 2025: A Scientific Vision. NIH is soliciting input from all interested stakeholders, including members of the scientific community, trainees, academic institutions, the private sector, health professionals, professional societies, advocacy groups, and patient communities, as well as other interested members of the public.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2018-17748
Type: Notice
Date: 2018-08-17
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.
Science and Regulation of Live Microbiome-Based Products Used To Prevent, Treat, or Cure Diseases in Humans; Public Workshop
Document Number: 2018-17732
Type: Notice
Date: 2018-08-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) Center for Biologics Evaluation and Research and the National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIAID) are announcing a public workshop entitled ``Science and Regulation of Live Microbiome- Based Products Used to Prevent, Treat, or Cure Diseases in Humans.'' The purpose of the public workshop is to exchange information with the scientific community about the clinical, manufacturing, and regulatory considerations associated with live microbiome-based products, when administered to prevent, treat, or cure a disease or condition in humans. The public workshop will bring together government Agencies, academia, industry, and other stakeholders involved in research, development, and regulation of live microbiome-based products for such uses.
Medical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments
Document Number: 2018-17731
Type: Proposed Rule
Date: 2018-08-17
Agency: Food and Drug Administration, Department of Health and Human Services
As required by the FDA Reauthorization Act of 2017 (FDARA), the Food and Drug Administration (FDA or Agency) has identified a list of accessories for which the Agency believes general controls alone are sufficient to provide reasonable assurance of safety and effectiveness, so the accessories could be in class I. FDA is publishing this document proposing to classify these accessories into class I and distinct from other devices, as well as seek public comment in accordance with procedures established by FDARA. This document does not represent FDA's final determination with respect to the proposed accessories listed in this document.
World Trade Center Health Program; Petition 019-Irritable Bowel Syndrome; Finding of Insufficient Evidence
Document Number: 2018-17711
Type: Proposed Rule
Date: 2018-08-17
Agency: Department of Health and Human Services
On May 17, 2018, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 019) to add irritable bowel syndrome (IBS) to the List of WTC-Related Health Conditions (List). Upon reviewing the scientific and medical literature, including information provided by the petitioner, the Administrator has determined that the available evidence does not have the potential to provide a basis for a decision on whether to add IBS to the List. The Administrator also finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a determination not to publish a proposed rule.
Medicare Program; Medicare Shared Savings Program; Accountable Care Organizations-Pathways to Success
Document Number: 2018-17101
Type: Proposed Rule
Date: 2018-08-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Under the Medicare Shared Savings Program (Shared Savings Program), providers of services and suppliers that participate in an Accountable Care Organization (ACO) continue to receive traditional Medicare fee-for-service (FFS) payments under Parts A and B, but the ACO may be eligible to receive a shared savings payment if it meets specified quality and savings requirements. The policies included in this proposed rule would provide a new direction for the Shared Savings Program by establishing pathways to success through redesigning the participation options available under the program to encourage ACOs to transition to two-sided models (in which they may share in savings and are accountable for repaying shared losses). These proposed policies are designed to increase savings for the Trust Funds and mitigate losses, reduce gaming opportunities, and promote regulatory flexibility and free-market principles. The proposed rule also would provide new tools to support coordination of care across settings and strengthen beneficiary engagement; ensure rigorous benchmarking; promote interoperable electronic health record technology among ACO providers/ suppliers; and improve information sharing on opioid use to combat opioid addiction.
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2019 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (Promoting Interoperability Programs) Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Medicare Cost Reporting Requirements; and Physician Certification and Recertification of Claims
Document Number: 2018-16766
Type: Rule
Date: 2018-08-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2019. Some of these changes implement certain statutory provisions contained in the 21st Century Cures Act and the Bipartisan Budget Act of 2018, and other legislation. We also are making changes relating to Medicare graduate medical education (GME) affiliation agreements for new urban teaching hospitals. In addition, we are providing the market basket update that will apply to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis, subject to these limits for FY 2019. We are updating the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long- term care hospitals (LTCHs) for FY 2019. In addition, we are establishing new requirements or revising existing requirements for quality reporting by specific Medicare providers (acute care hospitals, PPS-exempt cancer hospitals, and LTCHs). We also are establishing new requirements or revising existing requirements for eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) participating in the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (now referred to as the Promoting Interoperability Programs). In addition, we are finalizing modifications to the requirements that apply to States operating Medicaid Promoting Interoperability Programs. We are updating policies for the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital- Acquired Condition (HAC) Reduction Program. We also are making changes relating to the required supporting documentation for an acceptable Medicare cost report submission and the supporting information for physician certification and recertification of claims.
Agency Information Collection Activities; Proposed Collection; Comment Request; Surveys and Interviews With Investigational New Drug Sponsors To Assess Current Communication Practices With Food and Drug Administration Review Staff Under the Sixth Authorization of the Prescription Drug User Fee Act
Document Number: 2018-17715
Type: Notice
Date: 2018-08-16
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed information collection involving surveys and interviews of sponsors of commercial investigational new drugs (INDs) to obtain feedback about communication practices with FDA review staff.
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
Document Number: 2018-17702
Type: Notice
Date: 2018-08-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. Members will participate via teleconference.
National Institute of Dental and Craniofacial Research; Notice of Meeting
Document Number: 2018-17679
Type: Notice
Date: 2018-08-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2018-17677
Type: Notice
Date: 2018-08-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2018-17676
Type: Notice
Date: 2018-08-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Meeting
Document Number: 2018-17675
Type: Notice
Date: 2018-08-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2018-17674
Type: Notice
Date: 2018-08-16
Agency: Department of Health and Human Services, National Institutes of Health
National Advisory Committee on Rural Health and Human Services
Document Number: 2018-17623
Type: Notice
Date: 2018-08-16
Agency: Department of Health and Human Services
The Secretary's National Advisory Committee on Rural Health and Human Services (NACRHHS) has scheduled a public meeting. Information about NACRHHS and the agenda for this meeting can be found on the NACRHHS website at https://www.hrsa.gov/advisory-committees/ rural-health/index.html.
Meeting of the National Vaccine Advisory Committee
Document Number: 2018-17618
Type: Notice
Date: 2018-08-16
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services is hereby giving notice that a meeting is scheduled to be held for the National Vaccine Advisory Committee (NVAC). The meeting will be open to the public; public comment sessions will be held during the meeting.
Meeting of the Advisory Committee on Blood and Tissue Safety and Availability
Document Number: 2018-17617
Type: Notice
Date: 2018-08-16
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) will hold a meeting. The meeting will be open to the public.
Opportunity to Co-Sponsor Office of Research Integrity Workshops
Document Number: 2018-17615
Type: Notice
Date: 2018-08-16
Agency: Department of Health and Human Services, Office of the Secretary
The Office of Research Integrity (ORI) announces the opportunity for non-federal public and private sector entities to co- sponsor ORI conferences or workshops (ORI Workshops). Potential co- sponsors must have a demonstrated interest and experience in the responsible conduct of research (RCR) or the handling of research misconduct allegations. Potential co-sponsors must be willing to participate substantively in the co-sponsored activity. Expressions of interest for co-sponsorships of ORI Workshops are received throughout the year at the email address below. ORI co- sponsors a limited number of workshops with other entities each year. Expressions of interest are being received for ORI Workshops that will take place in the next fiscal year (October 2018 through September 2019) or beyond. Expressions of interest for co-sponsorships should be sent by email to AskORI@HHS.GOV with ``Co-sponsorship for ORI Workshops'' in the subject field or by mail to ORI at 1101 Wootton Parkway, Suite 750, Rockville, MD 20852.
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