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

Results 1 - 200 of 50,339
Technical Performance Assessment of Quantitative Imaging in Premarket Device Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2019-07936
Type: Notice
Date: 2019-04-19
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The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Technical Performance Assessment of Quantitative Imaging in Premarket Device Submissions.'' This draft guidance document provides recommendations on the information that should be included in premarket submissions for devices that include quantitative imaging functions. This draft guidance is not final nor is it in effect at this time.
Removal of Compliance Deadline for Closed-Circuit Escape Respirators and Clarification of Post-Approval Testing Standards for Closed-Circuit Escape Respirators
Document Number: 2019-07935
Type: Rule
Date: 2019-04-19
Agency: Department of Health and Human Services
With this deregulatory action, the Department of Health and Human Services (HHS) revises regulatory language to remove a deadline by which respirator manufacturers must discontinue the manufacturing, labeling, and sale of certain self-contained self-rescuer models. The National Institute for Occupational Safety and Health (NIOSH) within the Centers for Disease Control and Prevention, HHS, has determined that discontinuing the manufacturing, labeling, and sale of certain self-contained self-rescuer models is likely to result in a shortage of person-wearable large capacity escape respirators for underground coal miners who rely on these devices. In addition to removing the compliance deadline, HHS is also modifying regulatory language to clarify that post-approval testing of closed-circuit escape respirators may exclude human subject testing and environmental conditioning, at the discretion of NIOSH.
Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2019-07931
Type: Notice
Date: 2019-04-19
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The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Technical Considerations for Non-Clinical Assessment of Medical Devices containing Nitinol.'' Due to the unique properties of nitinol, the Agency has developed this draft guidance to provide FDA's current thinking on technical considerations specific to devices using nitinol. This draft guidance document is intended to provide clarity and consistency in recommended non-clinical assessments across a variety of medical devices that contain nitinol. This draft guidance is not final nor is it in effect at this time.
Bispecific Antibody Development Programs; Draft Guidance for Industry; Availability
Document Number: 2019-07930
Type: Notice
Date: 2019-04-19
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 ``Bispecific Antibody Development Programs.'' This draft guidance provides recommendations to assist industry and other parties involved in the bispecific antibody drug development process. The draft guidance focuses on general regulatory and scientific considerations for bispecific antibodies, but not on development of a particular bispecific antibody. Industry and other stakeholders are encouraged to engage FDA to discuss their individual bispecific antibody under development.
Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling: Nutrition Facts Label and Supplement Facts Label
Document Number: 2019-07929
Type: Notice
Date: 2019-04-19
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 collection of information for the nutrition facts label and supplement facts label, which the Agency believes will serve to promote and protect public health.
Proposed Substances To Be Evaluated for Toxicological Profile Development
Document Number: 2019-07916
Type: Notice
Date: 2019-04-19
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
The Agency for Toxic Substances and Disease Registry (ATSDR) within the Department of Health and Human Services is initiating the development of another set of Toxicological Profiles. This notice solicits public nominations of substances for ATSDR to evaluate for Toxicological Profile development. ATSDR will consider nominations from the Substance Priority List (available at https://www.atsdr.cdc.gov/ SPL/). ATSDR also accepts nominations for non-Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERLA) substances that may have public health implications, on the basis of ATSDR's authority to prepare Toxicological Profiles for substances not found at sites on the CERCLA National Priorities List. For more information on the CERCLA National Priorities List, visit https:// www.epa.gov/superfund/superfund-national-priorities-list-npl. The agency will do so in order to establish and maintain an inventory of literature, research, and studies on the health effects of toxic substances, to respond to requests for consultation, and to support the site-specific response actions conducted by ATSDR, as otherwise necessary.
Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Food Facilities
Document Number: 2019-07839
Type: Notice
Date: 2019-04-19
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 provisions of the Agency's regulations that require registration for domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States.
Adoption and Foster Care Analysis and Reporting System
Document Number: 2019-07827
Type: Proposed Rule
Date: 2019-04-19
Agency: Department of Health and Human Services, Administration for Children and Families
ACF proposes to amend the Adoption and Foster Care Analysis and Reporting System (AFCARS) regulations. This notice of proposed rulemaking (NPRM) amends the AFCARS regulations that require title IV-E agencies to collect and report data to ACF on children in out-of-home care, who exit out-of-home care to adoption or legal guardianship, and children who are covered by a title IV-E adoption or guardianship assistance agreement.
Aurolife Pharma, LLC, et al.; Withdrawal of Approval of 31 Abbreviated New Drug Applications
Document Number: 2019-07833
Type: Notice
Date: 2019-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 31 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Listing of Color Additives Exempt From Certification; Synthetic Iron Oxide; Confirmation of Effective Date
Document Number: 2019-07829
Type: Rule
Date: 2019-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is confirming the effective date of December 4, 2018, for the final rule that appeared in the Federal Register of November 1, 2018, and that amended the color additive regulations to provide for the expanded safe use of synthetic iron oxides as color additives to include use in dietary supplement tablets and capsules.
Determination That TRISENOX (Arsenic Trioxide) Injection, 1 Milligram/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2019-07828
Type: Notice
Date: 2019-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that TRISENOX (arsenic trioxide) injection, 1 milligram (mg)/milliliter (mL), 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 it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Agency Information Collection Activities; Proposed Collection; Comment Request; Abbreviated New Animal Drug Applications
Document Number: 2019-07764
Type: Notice
Date: 2019-04-18
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 provisions of abbreviated new animal drug applications.
The Declaration of Allulose and Calories From Allulose on Nutrition and Supplement Facts Labels: Draft Guidance for Industry; Availability
Document Number: 2019-07763
Type: Notice
Date: 2019-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels.'' The draft guidance, when finalized, will provide guidance on the declaration of allulose on Nutrition Facts and Supplement Facts labels as well as on the caloric content of allulose. The draft guidance, when finalized, also would advise manufacturers of our intent to exercise enforcement discretion for the exclusion of allulose from the amount of Total Sugars and Added Sugars declared on the Nutrition Facts and Supplement Facts label and use of a general factor of 0.4 calories per gram (kcal/g) for allulose.
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2019-07750
Type: Notice
Date: 2019-04-18
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-07748
Type: Notice
Date: 2019-04-18
Agency: Department of Health and Human Services, National Institutes of Health
Sunscreen Drug Products for Over-the-Counter Human Use; Correction
Document Number: 2019-07712
Type: Proposed Rule
Date: 2019-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a proposed rule relating to the regulation of over-the-counter (OTC) sunscreen monograph products that appeared in the Federal Register of February 26, 2019. The document was published with formulas that were illegible. These corrections are being made to improve the accuracy of the proposed rule.
Sunscreen Drug Products for Over-the-Counter Human Use; Extension of Comment Period
Document Number: 2019-07710
Type: Proposed Rule
Date: 2019-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the proposed rule that appeared in the Federal Register of February 26, 2019. In the proposed rule, FDA requested comments on its proposals relating to the regulation of over- the-counter (OTC) sunscreen monograph products. These proposals described the conditions under which the Agency proposes that OTC sunscreen monograph products are generally recognized as safe and effective and not misbranded. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Individual Patient Expanded Access Applications
Document Number: 2019-07711
Type: Notice
Date: 2019-04-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
National Committee on Vital and Health Statistics: Meeting
Document Number: 2019-07709
Type: Notice
Date: 2019-04-17
Agency: Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Comment Request; Manufactured Food Regulatory Program Standards
Document Number: 2019-07706
Type: Notice
Date: 2019-04-17
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 manufactured food regulatory program standards.
Advancing the Development and Implementation of Analysis Data Standards: Key Challenges and Opportunities; Public Workshop
Document Number: 2019-07700
Type: Notice
Date: 2019-04-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Advancing the Development and Implementation of Analysis Data Standards: Key Challenges and Opportunities.'' Convened by the Duke-Robert J. Margolis Center for Health Policy at Duke University in partnership with the Critical Path Institute and supported by a cooperative agreement with FDA, the purpose of the public workshop is to bring the stakeholder community together to discuss challenges and opportunities to advance the development and application of analysis data standards in drug development and regulatory review. This public workshop is being organized to fulfill FDA's commitment in section (I)(J)(5)(c) of the Prescription Drug User Fee Reauthorization Performance Goals and Procedures Fiscal Years 2018 through 2022 (PDUFA VI goals letter; available at https://www.fda.gov/downloads/forindustry/userfees/ prescriptiondruguserfee/ucm511438.pdf) to convene a public workshop to advance the development and application of analysis data standards. FDA will use the information from this public workshop to inform ongoing and future analysis data standards initiatives and strategic planning to improve the efficiency of regulatory review of electronic submissions.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-07644
Type: Notice
Date: 2019-04-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2019-07643
Type: Notice
Date: 2019-04-17
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2019-07581
Type: Notice
Date: 2019-04-16
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.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-07555
Type: Notice
Date: 2019-04-16
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; Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring
Document Number: 2019-07523
Type: Notice
Date: 2019-04-16
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: Proposed Collection; Comment Request
Document Number: 2019-07500
Type: Notice
Date: 2019-04-16
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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2019-07493
Type: Notice
Date: 2019-04-16
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: Proposed Collection; Comment Request
Document Number: 2019-07491
Type: Notice
Date: 2019-04-16
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.
Agency Information Collection Activities: Proposed Collection; Extension of Comment Period
Document Number: 2019-07474
Type: Notice
Date: 2019-04-16
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice extends the comment period for a 60-day notice request for proposed information collection request associated with the notice [Document Identifier: CMS-10630] entitled ``Programs of All- Inclusive Care for the Elderly (PACE) 2020 Audit Protocol'' that was published in the March 15, 2019 (84 FR 9526) Federal Register. The comment period for the information collection request, which would have ended on May 14, 2019, is extended to May 28, 2019.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Registering With the Center for Veterinary Medicine's Electronic Submission System
Document Number: 2019-07468
Type: Notice
Date: 2019-04-16
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 information collection provisions of the Center for Veterinary Medicine (CVM) Guidance for Industry (GFI) #108 entitled ``Registering with CVM's Electronic Submission System.''
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2019-07467
Type: Notice
Date: 2019-04-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tropical Disease Priority Review Vouchers
Document Number: 2019-07464
Type: Notice
Date: 2019-04-16
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.
Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Programs of All-Inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021
Document Number: 2019-06822
Type: Rule
Date: 2019-04-16
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule will revise the Medicare Advantage (MA) program (Part C) regulations and Prescription Drug Benefit program (Part D) regulations to implement certain provisions of the Bipartisan Budget Act of 2018; improve quality and accessibility; clarify certain program integrity policies for MA, Part D, and cost plans and PACE organizations; reduce burden on providers, MA plans, and Part D sponsors through providing additional policy clarification; and implement other technical changes regarding quality improvement. This final rule will also revise the appeals and grievances requirements for certain Medicaid managed care and MA special needs plans for dual eligible individuals to implement certain provisions of the Bipartisan Budget Act of 2018.
Medical Devices; Anesthesiology Devices; Classification of the Ventilatory Electrical Impedance Tomograph
Document Number: 2019-07463
Type: Rule
Date: 2019-04-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the ventilatory electrical impedance tomograph into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the ventilatory electrical impedance tomograph's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Determination of Regulatory Review Period for Purposes of Patent Extension; SYMPROIC
Document Number: 2019-07459
Type: Notice
Date: 2019-04-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SYMPROIC and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
The National Healthcare Safety Network's Proposed Requirement for Submission of Billing Codes as Part of Surgical Site Infection (SSI) Event Reporting; Request for Information
Document Number: 2019-07387
Type: Notice
Date: 2019-04-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention, in the Department of Health and Human Services, announces the opening of a docket to obtain information regarding the proposed requirement for reporting of International Classification of Diseases, 10th Revision, Procedural Classification System (ICD-10-PCS) or Current Procedures Terminology (CPT) Codes (collectively, Billing Codes) when reporting data to the National Healthcare Safety Network's (NHSN) Surgical Site Infection (SSI) Module of the Patient Safety Component. CDC is opening this docket to provide the opportunity to identify challenges for facilities to include ICD-10-PCS or CPT Codes when reporting SSI data to the NHSN, which is proposed to begin in 2021.
Agency Information Collection Request; 60-Day Public Comment Request
Document Number: 2019-07379
Type: Notice
Date: 2019-04-15
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.
Proposed Collection; 60-Day Comment Request; Post-Award Reporting Requirements Including Research Performance Progress Report Collection (OD)
Document Number: 2019-07354
Type: Notice
Date: 2019-04-12
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-07341
Type: Notice
Date: 2019-04-12
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Collection; 60-Day Comment Request; PHS Applications and Pre-Award Reporting Requirements (OD)
Document Number: 2019-07324
Type: Notice
Date: 2019-04-12
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-07303
Type: Notice
Date: 2019-04-12
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Evaluating and Implementing the Six Building Blocks Team Approach to Improve Opioid Management in Primary Care.''
Supplemental Evidence and Data Request on Skin Substitutes for Treating Chronic Wounds
Document Number: 2019-07302
Type: Notice
Date: 2019-04-12
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 on Skin Substitutes for Treating Chronic Wounds, 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.
Medical Devices; Classification of Accessories Distinct From Other Devices; Finalized List of Accessories Suitable for Class I
Document Number: 2019-07290
Type: Rule
Date: 2019-04-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, we, or Agency) is classifying suitable accessories into class I as required by the FDA Reauthorization Act of 2017 (FDARA). The Agency has determined that general controls alone are sufficient to provide reasonable assurance of safety and effectiveness for these accessories. We made this determination based on the risks of the accessories when used as intended with other devices such as the parent or system.
Meeting of the Advisory Committee on Organ Transplantation
Document Number: 2019-07278
Type: Notice
Date: 2019-04-12
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Advisory Committee on Organ Transplantation (ACOT) meeting has been rescheduled due to an unanticipated conflict and will now be held on Monday, May 20, 2019, from 10:00 a.m.-4:00 p.m. Eastern Time. The meeting will be held by webinar and conference call. The webinar link, conference call-in number, agenda, and instructions for registration will be posted 15 business days before the meeting on the ACOT website at https:// www.organdonor.gov/about-dot/acot.html.
Notice of Diabetes Mellitus Interagency Coordinating Committee Meeting
Document Number: 2019-07275
Type: Notice
Date: 2019-04-12
Agency: Department of Health and Human Services, National Institutes of Health
The Diabetes Mellitus Interagency Coordinating Committee (DMICC) will hold a meeting on May 30-31, 2019. The topic for this meeting will be ``Opportunities for Research Supported by the Special Statutory Funding Program for Type 1 Diabetes Research.'' The meeting is open to the public. Individuals planning to attend the workshop should register at https://www.scgcorp.com/dmiccworkshop2019 at least 7 days prior to the workshop.
Interagency Coordinating Committee on the Validation of Alternative Methods; Notice of Public Meeting; Request for Public Input
Document Number: 2019-07269
Type: Notice
Date: 2019-04-12
Agency: Department of Health and Human Services, National Institutes of Health
The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) will hold a public forum to share information and facilitate direct communication of ideas and suggestions from stakeholders. Interested persons may attend in person or view the meeting remotely by webcast. Time will be set aside for questions and public statements on the topics discussed. Registration is requested for both public attendance and oral statements, and required for remote access. Information about the meeting and registration are available at http://ntp.niehs.nih.gov/go/iccvamforum- 2019.
Notice of Closed Meeting
Document Number: 2019-07266
Type: Notice
Date: 2019-04-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2019-07250
Type: Notice
Date: 2019-04-12
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Amended Notice of Meeting
Document Number: 2019-07249
Type: Notice
Date: 2019-04-12
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2019-07248
Type: Notice
Date: 2019-04-12
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2019-07232
Type: Notice
Date: 2019-04-12
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. to achieve expeditious commercialization of results of federally-funded research and development.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Rural Communities Opioid Response Program Performance Measures, OMB No. 0906-xxxx, New
Document Number: 2019-07221
Type: Notice
Date: 2019-04-12
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2019-07126
Type: Notice
Date: 2019-04-12
Agency: Department of Health and Human Services
The Office of the Assistant Secretary for Health, National Vaccine Program Office organization has modified its organizational structure.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2019-07125
Type: Notice
Date: 2019-04-12
Agency: Department of Health and Human Services
The Office of the Assistant Secretary for Health, Office of Disease Prevention and Health Promotion organization has modified its organizational structure.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2019-07124
Type: Notice
Date: 2019-04-12
Agency: Department of Health and Human Services
The Office of the Assistant Secretary for Health, Office of Population Affairs organization has modified its organizational structure.
Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use
Document Number: 2019-06791
Type: Rule
Date: 2019-04-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is issuing this final action establishing that certain active ingredients used in nonprescription (also known as over-the-counter (OTC)) consumer antiseptic products intended for use without water (referred to throughout as consumer antiseptic rubs or consumer rubs) are not eligible for evaluation under the OTC Drug Review for use in consumer antiseptic rubs. Drug products containing these ineligible active ingredients will require approval under a new drug application (NDA) or abbreviated new drug application (ANDA) prior to marketing. FDA is issuing this final action after considering the recommendations of the Nonprescription Drugs Advisory Committee (NDAC), public comments on the Agency's notices of proposed rulemaking, and all data and information on OTC consumer antiseptic rub products that have come to the Agency's attention. This final action finalizes the 1994 tentative final monograph (TFM) for OTC consumer antiseptic rub drug products that published in the Federal Register of June 17, 1994 (the 1994 TFM), as amended by the proposed rule published in the Federal Register (FR) of June 30, 2016 (2016 Consumer Antiseptic Rub proposed rule).
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 2019-07210
Type: Notice
Date: 2019-04-11
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Y-12 Plant in Oak Ridge, Tennessee, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2019-07183
Type: Notice
Date: 2019-04-11
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human; Notice of Meeting
Document Number: 2019-07182
Type: Notice
Date: 2019-04-11
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Amended Notice of Meeting
Document Number: 2019-07181
Type: Notice
Date: 2019-04-11
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-07180
Type: Notice
Date: 2019-04-11
Agency: Department of Health and Human Services, National Institutes of Health
Responsible Innovation in Dietary Supplements; Public Meeting; Request for Comments
Document Number: 2019-07168
Type: Notice
Date: 2019-04-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``Responsible Innovation in Dietary Supplements.'' The purpose of the public meeting is to give interested parties an opportunity to present ideas for facilitating responsible innovation in the dietary supplement industry while preserving and strengthening FDA's ability to efficiently and effectively protect the public from unsafe and unlawful products.
Privacy Act; Implementation
Document Number: 2019-07122
Type: Rule
Date: 2019-04-11
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS or Department) is issuing this final rule to make effective the exemptions that HHS proposed for certain records covered in a new Privacy Act system of records, System No. 09-90-1701, HHS Insider Threat Program Records.
Medicare and Medicaid Programs: Approval of an Application From Accreditation Commission for Health Care, Inc. for CMS Approval of Its End Stage Renal Disease (ESRD) Facility Accreditation Program
Document Number: 2019-07135
Type: Notice
Date: 2019-04-10
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final notice announces our approval of the Accreditation Commission for Health Care, Inc. (ACHC) for recognition as a national accrediting organization (AO) for End Stage Renal Disease (ESRD) Facilities that wish to participate in the Medicare or Medicaid programs.
National Cancer Institute; Notice of Closed Meetings
Document Number: 2019-07089
Type: Notice
Date: 2019-04-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2019-07085
Type: Notice
Date: 2019-04-10
Agency: Department of Health and Human Services, National Institutes of Health
Advisory Committee on Immunization Practices (ACIP); Notice of Meeting and Request for Comment
Document Number: 2019-07064
Type: Notice
Date: 2019-04-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public, limited only by room seating. The meeting room accommodates 216 for public seating. Room 245, adjacent to the meeting room, will be available once the meeting room reaches capacity, providing up to 18 additional seats. Time will be available for public comment. The meeting will be webcast live via the World Wide Web; for meeting registration and more information on ACIP please visit the ACIP website: http://www.cdc.gov/vaccines/acip/index.html.
Notice of Closed Meeting
Document Number: 2019-07063
Type: Notice
Date: 2019-04-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2019-07035
Type: Notice
Date: 2019-04-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-07022
Type: Notice
Date: 2019-04-10
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 (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.
Compliance With Statutory Program Integrity Requirements
Document Number: 2019-06971
Type: Rule
Date: 2019-04-10
Agency: Department of Health and Human Services
This document corrects technical errors in the provisions that appeared in the final rule published in the Federal Register on March 4, 2019 titled ``Compliance with Statutory Program Integrity Requirements''.
National Institute of Dental & Craniofacial Research; Notice of Closed Meeting
Document Number: 2019-07005
Type: Notice
Date: 2019-04-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse: Notice of Closed Meeting
Document Number: 2019-07004
Type: Notice
Date: 2019-04-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Meeting
Document Number: 2019-07003
Type: Notice
Date: 2019-04-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2019-07002
Type: Notice
Date: 2019-04-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2019-07001
Type: Notice
Date: 2019-04-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases: Notice of Closed Meeting
Document Number: 2019-07000
Type: Notice
Date: 2019-04-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2019-06999
Type: Notice
Date: 2019-04-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2019-06998
Type: Notice
Date: 2019-04-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2019-06997
Type: Notice
Date: 2019-04-09
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Meeting
Document Number: 2019-06996
Type: Notice
Date: 2019-04-09
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Meetings
Document Number: 2019-06995
Type: Notice
Date: 2019-04-09
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-06994
Type: Notice
Date: 2019-04-09
Agency: Department of Health and Human Services, National Institutes of Health
Modifications to Compliance Policy for Certain Deemed Tobacco Products; Extension of Comment Period
Document Number: 2019-06952
Type: Notice
Date: 2019-04-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the draft guidance for industry entitled ``Modifications to Compliance Policy for Certain Deemed Tobacco Products'' that appeared in the Federal Register of March 14, 2019. In the draft guidance for industry, FDA requested comments on changes to the compliance policies for premarket review requirements for certain deemed tobacco products and how FDA intends to prioritize its enforcement resources with regard to the marketing of certain deemed tobacco products that do not have premarket authorization. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Submission for OMB Review; Comment Request
Document Number: 2019-06945
Type: Notice
Date: 2019-04-09
Agency: Department of Health and Human Services, Administration for Children and Families
Pharmaceutical Science and Clinical Pharmacology Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2019-06900
Type: Notice
Date: 2019-04-08
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.
Submission for OMB Review; Building Evidence on Employment Strategies for Low-Income Families (BEES) (New Collection)
Document Number: 2019-06898
Type: Notice
Date: 2019-04-08
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) is proposing a data collection activity as part of the Building Evidence on Employment Strategies for Low-Income Families (BEES). The purpose of BEES is to evaluate the effectiveness of a broad range of innovative programs designed to boost employment and earnings among low-income Americans. Within this general focus area, ACF has a particular interest in programs that serve adults whose employment prospects have been affected by substance use disorder (SUD), opioid use disorder (OUD), mental health conditions, and justice involvement. ACF expects that a subset of programs to be evaluated will serve these specific target populations. To meet these objectives, this study will include impact and implementation evaluations for up to 21 sites, as well as descriptive work focused on other sites that have a focus on clients with opioid use and other substance abuse disorders. When possible, a randomized control trial research design will be used for the impact evaluations. The purpose of the current submission is to request approval for data collection needed for the BEES study.
Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2019-06896
Type: Notice
Date: 2019-04-08
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 Oncologic 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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-06884
Type: Notice
Date: 2019-04-08
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.
Availability of Draft Toxicological Profile for Glyphosate
Document Number: 2019-06832
Type: Notice
Date: 2019-04-08
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
The Agency for Toxic Substances and Disease Registry (ATSDR), within the Department of Health and Human Services (HHS), announces the opening of a docket to obtain comments on the Draft Toxicological Profile for Glyphosate. On February 12, 2015 ATSDR announced that it was preparing to develop their Set 28 Draft Toxicological Profiles, including Glyphosate, for public comment release (80 FR 7870). All toxicological profiles issued as ``Drafts for Public Comment'' represent ATSDR's best efforts to provide important toxicological information on priority hazardous substances. ATSDR is seeking public comments and additional information or reports on studies about the health effects of glyphosate for review and potential inclusion in the profile. ATSDR considers key studies for these substances during the profile development process. This document solicits any relevant, additional studies. ATSDR will evaluate the quality and relevance of such data or studies for possible inclusion into the profile.
Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance; Extension of Comment Period
Document Number: 2019-06819
Type: Proposed Rule
Date: 2019-04-08
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document extends the comment period for the notice of proposed rulemaking with comment entitled ``Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance'' that appeared in the February 4, 2019 Federal Register. The comment period for the proposed rule, which would end on April 5, 2019, is extended 60 days.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-06816
Type: Notice
Date: 2019-04-08
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 Sealant Efficiency Assessment for Locals and States. This data will be collected from local school sealant programs to generate efficiency performance measures, which will allow CDC to identify feasible benchmarks and best practices contributing to school sealant program efficiency.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-06815
Type: Notice
Date: 2019-04-08
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 ``National Disease Surveillance ProgramI. Case Reports'' to collect disease-specific surveillance reports of four rare, uncommon, or infrequent diseases.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-06814
Type: Notice
Date: 2019-04-08
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 Stakeholder Interviews for the Evaluation of the World Trade Center Health Program (WTCHP) for Impact Assessment and Strategic Planning for Translational Research. This project will hold a series of semi-structured interviews with members of different stakeholder groups to explore their perspectives on the translational research mission of the WTCHP, including the use of research to improve care for members and impact on key program outcomes.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-06813
Type: Notice
Date: 2019-04-08
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 Verona Integron-Encoded Metallo- [beta]-Lactamase (VIM)-Producing Carbapenem-Resistant Pseudomonas aeruginosa Infections Associated with Invasive Medical Procedures in Tijuana, Mexico. This project is being developed to identify infections among individuals in the U.S. who had surgery at Facility 1 in Tijuana, Mexico in order to prevent the spread of resistance in the U.S.
Mesothelioma Registry Feasibility; Request for Information
Document Number: 2019-06784
Type: Notice
Date: 2019-04-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention (CDC), announces the opening of a docket to obtain information on the feasibility of a registry designed to track mesothelioma cases in the United States, as well as recommendations on enrollment, data collection, confidentiality, and registry maintenance. The purpose of such a registry would be to collect information that could be used to develop and improve standards of care and to identify gaps in mesothelioma prevention and treatment.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Evidence-Based Telehealth Network Program Measures, OMB No. 0906-xxxx-New
Document Number: 2019-06768
Type: Notice
Date: 2019-04-08
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Assessing Care and Health Outcomes Among Ryan White HIV/AIDS Program (RWHAP) Clients Who Do Not Receive RWHAP-Funded Outpatient Ambulatory Health Services (OAHS), OMB No. 0906-xxxx-New
Document Number: 2019-06767
Type: Notice
Date: 2019-04-08
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities: Proposed Collection: Public Comment Request: Information Collection Request Title: Health Center Program Forms, OMB No. 0915-0285-Revision
Document Number: 2019-06766
Type: Notice
Date: 2019-04-08
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
National Institute of Neurological Disorders and Stroke
Document Number: 2019-06737
Type: Notice
Date: 2019-04-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2019-06736
Type: Notice
Date: 2019-04-05
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Collection; 60-day Comment Request: A Generic Submission for Formative Research, Pretesting and Customer Satisfaction of NCI's Communication and Education Resources (NCI)
Document Number: 2019-06735
Type: Notice
Date: 2019-04-05
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.
Risk Evaluation and Mitigation Strategy: The Food and Drug Administration's Application of Statutory Factors in Determining When a Risk Evaluation and Mitigation Strategy Is Necessary; Guidance for Industry; Availability
Document Number: 2019-06663
Type: Notice
Date: 2019-04-05
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 ``Risk Evaluation and Mitigation Strategy: FDA's Application of Statutory Factors in Determining When a Risk Evaluation and Mitigation Strategy Is Necessary.'' This guidance is intended to clarify how FDA applies the factors set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act) in determining whether a risk evaluation and mitigation strategy (REMS) is necessary to ensure that the benefits of a drug outweigh its risks. This guidance is one of several developed to fulfill performance goals that FDA agreed to satisfy in the reauthorization of the prescription drug user fee program (the Prescription Drug User Fee Act (PDUFA) V). This guidance finalizes the draft guidance entitled ``FDA's Application of Statutory Factors in Determining When a REMS Is Necessary,'' issued September 21, 2016.
Determination That ANTIVERT Chewable Tablets, 25 Milligrams, and Tablets, 12.5 Milligrams, 25 Milligrams, and 50 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2019-06656
Type: Notice
Date: 2019-04-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that ANTIVERT (meclizine hydrochloride) chewable tablets, 25 milligrams (mg), and tablets, 12.5 mg, 25 mg, and 50 mg, were 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 these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Office of the Director; Notice of Charter Renewal
Document Number: 2019-06615
Type: Notice
Date: 2019-04-05
Agency: Department of Health and Human Services, National Institutes of Health
CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHACHSPT)
Document Number: 2019-06607
Type: Notice
Date: 2019-04-04
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC and the Health Resources and Services Administration (HRSA), announce the following meeting for the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHACHSPT). This meeting is open to the public, limited only by 90 seats and 70 ports for audio phone lines. Time will be available for public comment. The public is welcome to submit written comments in advance of the meeting. Comments should be submitted in writing by email to the contact person listed below. The deadline for receipts is Monday, May 13, 2019. Persons who desire to make an oral statement, may request it at the time of the public comments period on May 14, 2019 at 4:30 p.m., EDT.
Interagency Committee on Smoking and Health (ICSH); Notice of Charter Renewal
Document Number: 2019-06605
Type: Notice
Date: 2019-04-04
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Interagency Committee on Smoking and Health, Department of Health and Human Services, has been renewed for a 2-year period through March 20, 2021.
Mine Safety and Health Research Advisory Committee (MSHRAC)
Document Number: 2019-06604
Type: Notice
Date: 2019-04-04
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Mine Safety and Health Research Advisory Committee (MSHRAC). This meeting is open to the public, limited only by the space available. The meeting room accommodates approximately 75 people. If you wish to attend in person or by phone, please contact Marie Chovanec by email at MChovanec@cdc.gov or by phone at 412-386-5302 at least 5 business days in advance of the meeting.
Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2019-06602
Type: Notice
Date: 2019-04-04
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Advisory Board on Radiation and Worker Health (ABRWH). This meeting is open to the public, limited only by the space available. The meeting space accommodates approximately 150 people and the audio conference line has 150 ports for callers. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcome to listen to the meeting by joining the teleconference (information below).
Prospective Grant of an Exclusive/Co-Exclusive Patent License: Development and Commercialization of Next Generation Chimeric Antigen Receptor (CAR) Therapies for the Treatment of FMS-Like tyrosine kinase 3 (FLT3) Expressing Cancers
Document Number: 2019-06575
Type: Notice
Date: 2019-04-04
Agency: Department of Health and Human Services, National Institutes of Health
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive/Co-Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this Notice to Senti Bio (``Senti''), located in South San Francisco, CA.
Proposed Collection; 60-Day Comment Request; Scientific Information Reporting System (SIRS) (National Institute of General Medical Sciences)
Document Number: 2019-06572
Type: Notice
Date: 2019-04-04
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 Institute of General Medical Sciences (NIGMS), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
National Cancer Institute; Notice of Meeting
Document Number: 2019-06571
Type: Notice
Date: 2019-04-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meetings
Document Number: 2019-06570
Type: Notice
Date: 2019-04-04
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Charter Renewal
Document Number: 2019-06569
Type: Notice
Date: 2019-04-04
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2019-06568
Type: Notice
Date: 2019-04-04
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: 2019-06567
Type: Notice
Date: 2019-04-04
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; Providing Regulatory Submissions in Electronic and Non-Electronic Format-Promotional Labeling and Advertising Materials for Human Prescription Drugs
Document Number: 2019-06565
Type: Notice
Date: 2019-04-04
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; Proposed Collection; Comment Request; Guidance: Emergency Use Authorization of Medical Products and Related Authorities
Document Number: 2019-06553
Type: Notice
Date: 2019-04-04
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 proposed extension of the collection of information related to emergency use authorizations by the Agency.
Determination That QVAR 40 and QVAR 80 (Beclomethasone Dipropionate HFA) Inhalation Aerosol, 40 Micrograms and 80 Micrograms, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2019-06552
Type: Notice
Date: 2019-04-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that QVAR 40 and QVAR 80 (beclomethasone dipropionate HFA) inhalation aerosol, 40 micrograms (mcg) and 80 mcg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for QVAR 40 and QVAR 80 (beclomethasone dipropionate HFA) inhalation aerosol, 40 mcg and 80 mcg, if all other legal and regulatory requirements are met.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Accessories
Document Number: 2019-06551
Type: Notice
Date: 2019-04-04
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 information collections regarding medical device accessories requests.
Determination That CORTISPORIN (Hydrocortisone/Neomycin Sulfate/Polymyxin B Sulfate) Otic Solution, 10 Milligrams/Milliliter Hydrocortisone, 3.5 Milligrams Base/Milliliter Neomycin Sulfate, 10,000 Units/Milliliter Polymyxin B Sulfate, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2019-06549
Type: Notice
Date: 2019-04-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that CORTISPORIN (hydrocortisone/neomycin sulfate/polymyxin B sulfate) otic solution, 10 milligrams (mg)/milliliter (mL) hydrocortisone, 3.5 mg base/mL neomycin sulfate, 10,000 units/mL polymyxin B sulfate, 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 it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD); Notice of Meeting
Document Number: 2019-06455
Type: Notice
Date: 2019-04-03
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Closed Meeting
Document Number: 2019-06452
Type: Notice
Date: 2019-04-03
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2019-06451
Type: Notice
Date: 2019-04-03
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-06450
Type: Notice
Date: 2019-04-03
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Request; 60-Day Public Comment Request
Document Number: 2019-06440
Type: Notice
Date: 2019-04-03
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.
The Future of Insulin Biosimilars: Increasing Access and Facilitating the Efficient Development of Biosimilar and Interchangeable Insulin Products; Public Hearing; Request for Comments
Document Number: 2019-06438
Type: Proposed Rule
Date: 2019-04-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing a public hearing to discuss access to affordable insulin products and issues related to the development and approval of biosimilar and interchangeable insulin products.
Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds; Public Hearing; Request for Comments
Document Number: 2019-06436
Type: Proposed Rule
Date: 2019-04-03
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 hearing to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.
National Institute on Aging Notice of Closed Meeting
Document Number: 2019-06421
Type: Notice
Date: 2019-04-03
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2019-06420
Type: Notice
Date: 2019-04-03
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2019-06419
Type: Notice
Date: 2019-04-03
Agency: Department of Health and Human Services, National Institutes of Health
Meeting of the National Advisory Council for Healthcare Research and Quality
Document Number: 2019-06417
Type: Notice
Date: 2019-04-03
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.
Beverages: Bottled Water
Document Number: 2019-06201
Type: Proposed Rule
Date: 2019-04-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is proposing to revise the quality standard for bottled water to specify that bottled water to which fluoride is added by the manufacturer may not contain fluoride in excess of 0.7 milligrams per liter (mg/L). This action, if finalized, will revise the current allowable levels for fluoride in domestically packaged and imported bottled water to which fluoride is added. We are taking this action to make the quality standard regulation for fluoride added to bottled water consistent with the recommendation by the U.S. Public Health Service (PHS) for community water systems that add fluoride for the prevention of dental caries. This action, if finalized, will not affect the allowable levels for fluoride in bottled water to which fluoride is not added by the manufacturer (such bottled water may contain fluoride from its source water).
Limited Population Pathway for Antibacterial and Antifungal Drugs; Public Meeting; Request for Comments
Document Number: 2019-06390
Type: Notice
Date: 2019-04-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``Limited Population Pathway for Antibacterial and Antifungal Drugs.'' The purpose of the meeting is to provide a public forum for FDA to listen to comments on the draft guidance for industry, ``Limited Population Pathway for Antibacterial and Antifungal Drugs,'' that was published in the Federal Register on June 13, 2018. FDA is also reopening the comment period on this draft guidance for comments to be submitted for consideration before we finish work on the final version of the guidance.
Pulmonary-Allergy Drugs Advisory Committee; Cancellation
Document Number: 2019-06389
Type: Notice
Date: 2019-04-02
Agency: Food and Drug Administration, Department of Health and Human Services
The meeting of the Pulmonary-Allergy Drugs Advisory Committee scheduled for March 27, 2019, has been cancelled. This meeting was announced in the Federal Register of January 31, 2019. This meeting has been cancelled due to new information regarding the application. The Agency intends to continue evaluating the application and, as needed, will announce future meeting dates in the Federal Register.
Post-Marketing Pediatric-Focused Product Safety Reviews; Establishment of a Public Docket; Request for Comments
Document Number: 2019-06385
Type: Notice
Date: 2019-04-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is establishing a public docket to collect comments related to the post-marketing pediatric-focused safety reviews of products posted between October 12, 2018, and April 1, 2019, on FDA's website but not presented at the April 8, 2019, Pediatric Advisory Committee (PAC) meeting. These reviews are intended to be available for review and comment by members of the PAC, interested parties (such as academic researchers, regulated industries, consortia, and patient groups), and the general public.
Determination That CHLOR-TRIMETON ALLERGY 12 HOUR (Chlorpheniramine Maleate) Extended Release Tablets, 8 Milligrams and 12 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2019-06382
Type: Notice
Date: 2019-04-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that CHLOR-TRIMETON ALLERGY 12 HOUR (chlorpheniramine maleate) extended release tablets, 8 milligrams (mg) and 12 mg, were 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 it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Determination That ONFI (Clobazam) Tablets, 5 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2019-06381
Type: Notice
Date: 2019-04-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that ONFI (clobazam) tablets, 5 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) that refer to the drug product, if all other legal and regulatory requirements are met.
Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for Quick Turnaround Testing of Communication Effectiveness
Document Number: 2019-06365
Type: Notice
Date: 2019-04-02
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 new collection of information entitled ``Generic Clearance for Quick Turnaround Testing of Communication Effectiveness.''
Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee; Renewal
Document Number: 2019-06360
Type: Notice
Date: 2019-04-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the renewal of the Technical Electronic Product Radiation Safety Standards Committee (Committee) by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until December 24, 2020.
Biodefense Summit: Implementing the National Biodefense Strategy: Notification of Public Meeting and Solicitation of Advice
Document Number: 2019-06330
Type: Notice
Date: 2019-04-02
Agency: Department of Health and Human Services
The HHS Assistant Secretary for Preparedness and Response (ASPR) in the Department of Health and Human Services (HHS) is announcing a public meeting, Biodefense Summit: Implementing the National Biodefense Strategy (Strategy). Implementing the Strategy involves partners among multiple sectors, including medical; public, animal, and plant health; emergency response; scientific and technical; law enforcement; industrial; academic; diplomatic; defense and security; intelligence; and nonproliferation and counterproliferation stakeholders. This meeting is being held to introduce the Strategy to these groups and to solicit feedback from them. The meeting will be open to representatives from invited organizations and the public.
National Biodefense Science Board: Call for Nominees
Document Number: 2019-06329
Type: Notice
Date: 2019-04-02
Agency: Department of Health and Human Services
The Office of the Assistant Secretary for Preparedness and Response (ASPR), in the Department of Health and Human Services (HHS) seeks applications from qualified individuals for membership on the National Biodefense Science Board (NBSB) or (Board). Terms of five members expire December 31, 2019; therefore, the HHS Secretary (Secretary) will appoint five new voting members. Applicants to those positions may be nominated by a relevant organization or may nominate themselves based on their expertise within the following stakeholder groups: Industry, academia, health care consumer organizations, and organizations representing other appropriate stakeholders. Please visit the NBSB website at https://www.phe.gov/nbsb for all application submission information, additional information regarding the qualifications expected for applicants, and application instructions.
Meeting of the Pain Management Best Practices Inter-Agency Task Force
Document Number: 2019-06328
Type: Notice
Date: 2019-04-02
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.
Training Program for Regulatory Project Managers; Information Available to Industry
Document Number: 2019-06327
Type: Notice
Date: 2019-04-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA or the Agency) Center for Drug Evaluation and Research (CDER) is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program (the Site Tours Program). The purpose of this document is to invite pharmaceutical companies interested in participating in this program to contact CDER.
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: 2019-06326
Type: Notice
Date: 2019-04-02
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.
Youth Tobacco Cessation: Science and Treatment Strategies; Public Scientific Workshop; Request for Comments
Document Number: 2019-06323
Type: Notice
Date: 2019-04-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public scientific workshop entitled ``Youth Tobacco Cessation: Science and Treatment Strategies.'' The purpose of the workshop is to discuss the unique challenges associated with youth tobacco addiction and cessation, and the current science regarding youth tobacco use and addiction as well as treatment strategies to support youth tobacco cessation.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-06312
Type: Notice
Date: 2019-04-02
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 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 Childcare Survey of Activity and Wellness (C-SAW) Pilot Study. The pilot study will determine the current practices and policies of early care and education (ECE) providers in four states around nutrition, physical activity, and wellness and will inform the development of a potential national surveillance system.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-06311
Type: Notice
Date: 2019-04-02
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 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 information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the Million Hearts[supreg] Hospital/Health System Recognition Program that recognizes institutions working systematically to improve the cardiovascular health of the population and communities they serve.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-06306
Type: Notice
Date: 2019-04-02
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 collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Information Collection on Soil- transmitted Helminth Infections in Alabama and Mississippi. CDC requests OMB approval to collect information on prevalence and distribution of soil-transmitted helminth infections and potential risk factors.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-06305
Type: Notice
Date: 2019-04-02
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 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 ``Drug Overdose Surveillance and Epidemiology (DOSE).'' This new data collection effort is an essential component toward reducing the opioid crisis, one of HHS Department's top priorities. DOSE data is critical to our ability to rapidly identify outbreaks and provide situational awareness of changes in emergency department (ED) visits involving suspected drug, opioid, heroin and stimulant overdoses at the local, state, and regional level.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2019-06304
Type: Notice
Date: 2019-04-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2019-06303
Type: Notice
Date: 2019-04-02
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2019-06302
Type: Notice
Date: 2019-04-02
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
Basic Health Program; Federal Funding Methodology for Program Years 2019 and 2020
Document Number: 2019-06276
Type: Proposed Rule
Date: 2019-04-02
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document proposes the methodology and data sources necessary to determine federal payment amounts to be made in program years 2019 and 2020 to states that elect to establish a Basic Health Program under the Patient Protection and Affordable Care Act to offer health benefits coverage to low-income individuals otherwise eligible to purchase coverage through Affordable Insurance Exchanges. Prior to the final notice being published, Basic Health Program (BHP) payments will be made using the methodology described in the Final Administrative Order published on August 24, 2018. Payments for 2019 will be conformed to the finalized 2019 payment methodology through reconciliation.
Revocation of the Test for Mycoplasma
Document Number: 2019-06188
Type: Proposed Rule
Date: 2019-04-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is proposing to amend the biologics regulations by removing the specified test for the presence of Mycoplasma for live virus vaccines and inactivated virus vaccines produced from in vitro living cell cultures. FDA is proposing this action because the existing test for Mycoplasma is restrictive in that it identifies only one test method in detail to be used even though other methods also may be appropriate. More sensitive and specific methods exist and are currently being practiced, and removal of the specific method to test for Mycoplasma provides flexibility for accommodating new and evolving technology and capabilities without diminishing public health protections. This action is part of FDA's implementation of Executive Orders 13771 and 13777. Under these Executive orders, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction, while allowing the Agency to achieve our public health mission and fulfill statutory obligations.
Removal of Certain Time of Inspection and Duties of Inspector Regulations for Biological Products
Document Number: 2019-06187
Type: Rule
Date: 2019-04-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule amending the general biologics regulations relating to time of inspection requirements and also removing duties of inspector requirements. FDA is taking this action to remove outdated requirements and accommodate new approaches, such as a risk-based inspection frequency for drug and device establishments, thereby providing flexibility without diminishing public health protections. This action is part of FDA's implementation of Executive Orders (E.O.s) 13771 and 13777. Under these E.O.s, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction, while allowing the Agency to achieve our public health mission and fulfill statutory obligations.
Implementing the Food and Drug Administration Food Safety Modernization Act; Technical Amendment
Document Number: 2019-06141
Type: Rule
Date: 2019-04-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is correcting with technical amendments two final rules that published in the Federal Register of September 17, 2015, and one final rule that published in the Federal Register of November 27, 2015. The final rules published with editorial and inadvertent errors. This document corrects those errors.
New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
Document Number: 2019-06136
Type: Rule
Date: 2019-04-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during October, November, and December 2018. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to make technical amendments to improve the readability of the regulations.
Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports
Document Number: 2019-05787
Type: Proposed Rule
Date: 2019-04-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing a proposed rule to establish requirements for the content and format of reports intended to establish the substantial equivalence of a tobacco product (SE Reports). The proposed rule would establish the information an SE Report must include so that FDA may make a substantial equivalence determination. In addition, the proposed rule would establish the general procedures FDA intends to follow when evaluating SE Reports, including procedures that would address communications with the applicant and the confidentiality of data in an SE Report. The proposed rule is intended to provide more clarity to applicants and support efficient and predictable reviews of SE Reports.
Medicaid Program; Covered Outpatient Drug; Line Extension Definition; and Change to the Rebate Calculation for Line Extension Drugs
Document Number: 2019-06274
Type: Rule
Date: 2019-04-01
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This interim final rule with comment period revises the regulatory text to accurately reflect the applicable statutory language describing the rebate calculation for line extension drugs, which was revised by the Bipartisan Budget Act (BBA) of 2018. In addition, we also are issuing a final rule which responds to comments on the definition and identification of line extension drugs for which we requested additional comments in the Covered Outpatient Drugs final rule with comment period published in the February 1, 2016 Federal Register.
Advisory Committee for Women's Services (ACWS); Notice of Meeting
Document Number: 2019-06255
Type: Notice
Date: 2019-04-01
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration (samhsa)
Reinstatement of Color Additive Listing for Lead Acetate
Document Number: 2019-06238
Type: Rule
Date: 2019-04-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is reinstating the provision removed by our October 2018 final rule to amend the color additive regulations to no longer provide for the use of lead acetate in cosmetics intended for coloring hair on the scalp. This action does not reflect any change in our determination that new data demonstrate that there is no longer a reasonable certainty of no harm from the use of this color additive. We are reinstating this provision only because it was removed from the Code of Federal Regulations before we had the opportunity to take final action on the objections we received to the October 2018 final rule. This provision is being reinstated pending final FDA action on objections to the final rule.
Teva Women's Health, Inc., et al.; Withdrawal of Approval of 16 New Drug Applications
Document Number: 2019-06237
Type: Notice
Date: 2019-04-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 16 new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Office of the Director, National Institutes of Health; Notice of Closed Meeting
Document Number: 2019-06233
Type: Notice
Date: 2019-04-01
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2019-06232
Type: Notice
Date: 2019-04-01
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2019-06231
Type: Notice
Date: 2019-04-01
Agency: Department of Health and Human Services, National Institutes of Health
Clinical Center Notice of Meeting
Document Number: 2019-06230
Type: Notice
Date: 2019-04-01
Agency: Department of Health and Human Services, National Institutes of Health
Findings of Research Misconduct
Document Number: 2019-06206
Type: Notice
Date: 2019-04-01
Agency: Department of Health and Human Services, Office of the Secretary
Findings of research misconduct have been made against Edward J. Fox, Ph.D. (Respondent), Acting Assistant Professor in the Department of Pathology, University of Washington (UW). Dr. Fox engaged in research misconduct in research supported by National Cancer Institute (NCI), National Institutes of Health (NIH), grants R01 CA193649, R01 CA160674, P01 CA77852, and R01 CA102029. The administrative actions, including supervision for a period of one (1) year, were implemented beginning on March 18, 2019, and are detailed below.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-06193
Type: Notice
Date: 2019-04-01
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve a revision and to extend the time period of the proposed information collection project ``The AHRQ Safety Program for Improving Antibiotic Use.''
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-06192
Type: Notice
Date: 2019-04-01
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Online Submission Form for Supplemental Evidence and Data for Systematic Reviews for the Evidence-based Practice Center Program.''
Charter Renewal for the Advisory Committee on Interdiciplinary, Community-Based Linkages
Document Number: 2019-06162
Type: Notice
Date: 2019-04-01
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Advisory Committee on Interdiciplinary, Community-Based Linkages (ACICBL or the Committee) has been rechartered. The effective date of the renewed charter is March 24, 2019.
Charter Renewal for the Advisory Committee on Training in Primary Care Medicine and Dentistry
Document Number: 2019-06161
Type: Notice
Date: 2019-04-01
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD or the Committee) has been rechartered. The effective date of the renewed charter is March 24, 2019.
Medicare and Medicaid Programs: Application From the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF) for Its Outpatient Physical Therapy and Speech Language Pathology Services Accreditation Program
Document Number: 2019-06149
Type: Notice
Date: 2019-04-01
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final notice announces our decision to approve the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF) for continued recognition as a national accrediting organization for clinics, rehabilitation agencies, or public health agencies that furnish outpatient physical therapy and speech language pathology services that wish to participate in the Medicare or Medicaid programs.
Medicare Program; Public Meeting on June 24, 2019 Regarding New and Reconsidered Clinical Diagnostic Laboratory Test Codes for the Clinical Laboratory Fee Schedule for Calendar Year 2020
Document Number: 2019-06148
Type: Notice
Date: 2019-04-01
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a public meeting to receive comments and recommendations (including data on which recommendations are based) from the public on the appropriate basis for establishing payment amounts for new or substantially revised Healthcare Common Procedure Coding System (HCPCS) codes being considered for Medicare payment under the Clinical Laboratory Fee Schedule (CLFS) for calendar year (CY) 2020. This meeting also provides a forum for those who submitted certain reconsideration requests regarding final determinations made last year on new test codes and for the public to provide comment on the requests. The Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (Advisory Panel on CDLTs) will participate in this CLFS Annual Public Meeting by gathering information and asking questions to presenters, and will hold its next public meeting on July 22 and 23, 2019. The public meeting for the Advisory Panel on CDLTs will focus on the discussion of and recommendations for test codes presented during the June 24, 2019 CLFS Annual Public Meeting. The Panel meeting also will address any other CY 2020 CLFS issues that are designated in the Panel's charter and specified on the meeting agenda.
Medicare Program; Meeting Announcement for the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests
Document Number: 2019-06147
Type: Notice
Date: 2019-04-01
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the next public meeting dates for the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel) on Monday, July 22, 2019 and Tuesday, July 23, 2019. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on issues related to clinical diagnostic laboratory tests.
Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product
Document Number: 2019-06145
Type: Notice
Date: 2019-04-01
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 material threat medical countermeasure (MCM) product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the 21st Century Cures Act (Cures Act), authorizes FDA to award priority review vouchers to sponsors of approved material threat MCM product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. On July 13, 2018, FDA determined that TPOXX (tecovirimat), manufactured by SIGA Technologies, Inc., meets the criteria for a priority review voucher.
Medical Devices; Technical Amendment
Document Number: 2019-06139
Type: Rule
Date: 2019-04-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is amending the medical device reports of corrections and removals regulation to correct three inaccurate cross-references. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.
Microbiology Devices; Classification of In Vitro Diagnostic Devices for Bacillus Species Detection
Document Number: 2019-06026
Type: Rule
Date: 2019-04-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to classify in vitro diagnostic devices for Bacillus species (spp.) detection into class II (special controls) and to continue to require a premarket notification (510(k)) to provide a reasonable assurance of safety and effectiveness of the device. FDA is also establishing special controls in a special controls guideline in addition to restricting use and distribution of the devices. An in vitro diagnostic device for Bacillus spp. detection is a prescription device used to detect and differentiate among Bacillus spp. and presumptively identify B. anthracis and other Bacillus spp. from cultured isolates or clinical specimens as an aid in the diagnosis of anthrax and other diseases caused by Bacillus spp.
Medical Devices; Orthopedic Devices; Classification of Posterior Cervical Screw Systems
Document Number: 2019-06024
Type: Rule
Date: 2019-04-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to classify posterior cervical screw systems into class II (special controls) and to continue to require a premarket notification (510(k)) to provide a reasonable assurance of safety and effectiveness of the device. A posterior cervical screw system is a device used to provide immobilization and stabilization in the cervical spine as an adjunct to spinal fusion surgery. The term ``posterior cervical screw systems'' is used to distinguish these devices from currently classified thoracolumbosacral pedicle screw systems for use in other spinal regions.
Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-Ray, Laser and Ultrasonic Products
Document Number: 2019-05822
Type: Proposed Rule
Date: 2019-04-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is proposing to amend and repeal parts of the radiological health regulations covering recommendations for radiation protection during medical procedures, certain records and reporting for electronic products, and performance standards for diagnostic x-ray systems and their major components, laser products, and ultrasonic therapy products. The Agency is proposing this action to clarify and update the regulations to reduce regulatory requirements that are outdated and duplicate other means to better protect the public health against harmful exposure to radiation emitting electronic products and medical devices. This action is part of FDA's implementation of Executive Orders (EOs) 13771 and 13777. Under these EOs, FDA is comprehensively reviewing existing regulations to identify opportunities for repealing and amending regulations that will result in meaningful burden reduction while allowing the Agency to achieve our public health mission and fulfill statutory obligations.
Announcement of the Approval of the Accreditation Association for Hospitals and Health Systems/Healthcare Facilities Accreditation Program (Formerly Known as the American Osteopathic Association/Healthcare Facilities Accreditation Program) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988
Document Number: 2019-06291
Type: Notice
Date: 2019-03-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the approval of the application of the Accreditation Association for Hospitals and Health Systems/Healthcare Facilities Accreditation Program (AAHHS/HFAP) as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for all specialty and subspecialty areas under CLIA. We have determined that the AAHHS/HFAP meets or exceeds the applicable CLIA requirements. We are announcing the approval and granting the AAHHS/HFAP deeming authority for a period of 4 years.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2019-06143
Type: Notice
Date: 2019-03-29
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: 2019-06138
Type: Notice
Date: 2019-03-29
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 SYMDEKO (tezacaftor/ivacaftor), manufactured by Vertex Pharmaceutical, Inc., meets the criteria for a priority review voucher.
Advisory Council on Alzheimer's Research, Care, and Services; Meeting
Document Number: 2019-06135
Type: Notice
Date: 2019-03-29
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 April 29, 2019 meeting of the Advisory Council will focus on person-centered planning for older adults including information about implementation of care plans for people living with cognitive symptoms. There will also be discussion about the use of antipsychotic medication for people with dementia and other conditions living in community settings.
Solicitation of Nominations for Appointment to the Advisory Committee on Breast Cancer in Young Women (ACBCYW)
Document Number: 2019-06092
Type: Notice
Date: 2019-03-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the ACBCYW. The ACBCYW consists of 15 experts in fields associated with breast cancer, disease prevention, early detection, diagnosis, public health, social marketing, genetic screening and counseling, treatment, rehabilitation, palliative care, and survivorship in young women, or in related disciplines with a specific focus on young women. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the committee's objectives. Nominees will be selected based on expertise in the fields of breast health, breast cancer, disease prevention and risk reduction, survivorship (including metastatic breast cancer), hereditary breast and ovarian cancer (HBOC), or in related disciplines with a specific focus on young women. Persons with personal experience with early onset breast cancer are also eligible to apply. This includes, but may not be limited to breast cancer survivors
Notice of Closed Meeting
Document Number: 2019-06091
Type: Notice
Date: 2019-03-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Solicitation of Nominations for Appointment to the Healthcare Infection Control Practices Advisory Committee (HICPAC)
Document Number: 2019-06090
Type: Notice
Date: 2019-03-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the HICPAC. The HICPAC consists of 14 experts in fields including but not limited to, infectious diseases, infection prevention, healthcare epidemiology, nursing, clinical microbiology, surgery, hospitalist medicine, internal medicine, epidemiology, health policy, health services research, public health, and related medical fields. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the committee's objectives. Nominees will be selected based on expertise in the fields of infectious diseases, infection prevention, healthcare epidemiology, nursing, environmental and clinical microbiology, surgery, internal medicine, and public health. Federal employees will not be considered for membership. Members may be invited to serve for four-year terms. Selection of members is based on candidates' qualifications to contribute to the accomplishment of HICPAC objectives https:// www.cdc.gov/hicpac/.
Solicitation of Nominations for Appointment to the Mine Safety and Health Research Advisory Committee (MSHRAC)
Document Number: 2019-06089
Type: Notice
Date: 2019-03-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the MSHRAC, NIOSH. The MSHRAC consists of 13 experts in fields associated with mining safety and health. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the committee's objectives. Nominees will be selected based on expertise in the fields of mining safety and health, such as mining engineering, industrial hygiene, occupational safety and health engineering, chemistry, safety and health education, ergonomics, epidemiology, statistics, and psychology. Federal employees will not be considered for membership. Members may be invited to serve for up to four-year terms. Selection of members is based on candidates' qualifications to contribute to the accomplishment of MSHRAC's objectives.
Healthcare Infection Control Practices Advisory Committee (HICPAC)
Document Number: 2019-06088
Type: Notice
Date: 2019-03-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Healthcare Infection Control Practices Advisory Committee (HICPAC). This meeting is open to the public, is limited only by room seating available, (120). The public is also welcome to listen to the meeting via teleconference at 888-455- 9748, passcode: 4373458; 100 teleconference lines are available. Time will be available for public comment. The public is welcome to submit written comments in advance of the meeting. Comments should be submitted in writing by email to the contact person listed below. The deadline for receipt of written public comment is May 2, 2019. All requests must contain the name, address, and organizational affiliation of the speaker, as well as the topic being addressed. Written comments should not exceed one single-spaced typed page in length and delivered in 3 minutes or less. Members of the public who wish to provide public comments should plan to attend the public comment session at the start time listed. Please note that the public comment period may end before the time indicated, following the last call for comments. Written comments received in advance of the meeting will be included in the official record of the meeting. Registration is required to attend in person or on the phone. Interested parties must be processed in accordance with established federal policies and procedures and may register at https://www.cdc.gov/hicpac/.
Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS)
Document Number: 2019-06087
Type: Notice
Date: 2019-03-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC, announces the following meeting for the Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS). This meeting is open to the public; limited only by available seating. The meeting room accommodates approximately 78 people. Requests to make oral presentations should be submitted in writing to Gwen Mustaf, 301- 458-4500, glm4@cdc.gov, or Sayeedha Uddin, isx9@cdc.gov. All requests must contain the name, address, telephone number, and organizational affiliation of the presenter. Written comments should not exceed five single-spaced typed pages in length and must be received by April 24, 2019.
Board of Scientific Counselors, Office of Infectious Diseases (BSC, OID)
Document Number: 2019-06086
Type: Notice
Date: 2019-03-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, Office of Infectious Diseases (BSC, OID). This meeting is open to the public, limited only by the space available; the meeting room will accommodate up to 100 people. The public is also welcome to listen to the meeting by telephone, limited only by the number of ports available (100); the toll-free dial-in number is 1-877-951-7311, with a passcode of 2286986.
Center for Mental Health Services; Notice of Meeting
Document Number: 2019-06081
Type: Notice
Date: 2019-03-29
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water
Document Number: 2019-06069
Type: Notice
Date: 2019-03-29
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.
Review and Update of Device Establishment Inspection Processes and Standards; Draft Guidance for Industry; Availability
Document Number: 2019-06061
Type: Notice
Date: 2019-03-29
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 ``Review and Update of Device Establishment Inspection Processes and Standards.'' FDA is issuing this draft guidance document 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), which requires that FDA review and update, as needed, the processes and standards applicable to inspections (other than for-cause) of domestic and foreign medical device establishments in place as of August 18, 2017. This draft guidance describes how FDA will implement uniform inspection processes and standards. The draft guidance also describes standardized methods of communication during the inspection process and identifies practices for investigators and device establishments to facilitate the continuity of inspections of such establishments. This draft guidance is not final nor is it in effect at this time.
Submission for OMB Review; Comment Request
Document Number: 2019-06059
Type: Notice
Date: 2019-03-29
Agency: Department of Health and Human Services, Administration for Children and Families