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

Results 101 - 150 of 280
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2019 Rates; Proposed Quality Reporting Requirements for Specific Providers; Proposed Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (Promoting Interoperability Programs) Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Medicare Cost Reporting Requirements; and Physician Certification and Recertification of Claims; Correction
Document Number: 2018-13152
Type: Proposed Rule
Date: 2018-06-20
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical and typographical errors in the proposed rule that appeared in the May 7, 2018 issue of the Federal Register titled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2019 Rates; Proposed Quality Reporting Requirements for Specific Providers; Proposed Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (Promoting Interoperability Programs) Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Medicare Cost Reporting Requirements; and Physician Certification and Recertification of Claims''.
Federal Policy for the Protection of Human Subjects: Six Month Delay of the General Compliance Date of Revisions While Allowing the Use of Three Burden-Reducing Provisions During the Delay Period
Document Number: 2018-13187
Type: Rule
Date: 2018-06-19
Agency: Agency for International Development, Agencies and Commissions, Department of Transportation, Social Security Administration, National Science Foundation, National Aeronautics and Space Administration, Department of Labor, Department of Housing and Urban Development, Department of Homeland Security, Department of Health and Human Services, Environmental Protection Agency, Department of Energy, Department of Education, Department of Defense, Consumer Product Safety Commission, Department of Commerce, Department of Agriculture, Department of Veterans Affairs
In a final rule published on January 19, 2017, a number of federal departments and agencies revised to the Federal Policy for the Protection of Human Subjects (often referred to as the ``Common Rule''), which each department and agency adopted into regulations in its part of the Code of Federal Regulations (CFR). The Consumer Product Safety Commission (CPSC) adopted the same changes in a final rule published on September 18, 2017. The revised Common Rule was scheduled to become effective on January 19, 2018, with a general compliance date of the same date. By an interim final rule issued on January 17, 2018 and published in the Federal Register on January 22, 2018, federal departments and agencies delayed the effective date and the general compliance date for the revised Common Rule for a 6-month period, until July 19, 2018. The Department of Housing and Urban Development (HUD) published an interim final rule adopting the same regulatory changes on January 26, 2018. The revised Common Rule, including technical amendments made by the January 22, 2018 interim final rule, is referred to here as the ``2018 Requirements.'' On April 20, 2018, the federal departments and agencies listed here published a notice of proposed rulemaking (NPRM) proposing and seeking comments as to whether the general compliance date for the 2018 Requirements should be delayed for an additional 6-month period. The NPRM also proposed and sought comments on whether to allow regulated entities to implement certain burden-reducing provisions of the 2018 Requirements in specified circumstances during such continued delay period. Through this final rule, we are adopting the proposals described in the April 20, 2018 NPRM. This rule delays the general compliance date for the 2018 Requirements for an additional 6-month period, until January 21, 2019. As a result of this delay, regulated entities will be required, with an exception, to continue to comply with the requirements of the pre-2018 version of the Federal Policy for the Protection of Human Subjects (the ``pre-2018 Requirements'') until January 21, 2019. The one exception to this general rule is that institutions will be permitted (but not required) to implement, for certain research, three burden-reducing provisions of the 2018 Requirements during the delay period (July 19, 2018, through January 20, 2019). Those three provisions are: The revised definition of ``research,'' which deems certain activities not to be research covered by the Common Rule; the elimination of the requirement for annual continuing review with respect to certain categories of research; and the elimination of the requirement that institutional review boards (IRBs) review grant applications or other funding proposals related to the research. Institutions taking advantage of the three-burden reducing provisions must comply with all other pre-2018 Requirements during the delay period. The three burden-reducing provisions of the 2018 Requirements can only be implemented during the delay period with respect to studies initiated prior to January 21, 2019 that will transition to compliance with the revised Common Rule. Any study that implements these three burden-reducing provisions during the delay period must, beginning on January 21, 2019, comply with all of the 2018 Requirements for the balance of the study's duration.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-13149
Type: Notice
Date: 2018-06-19
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.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2018-13138
Type: Notice
Date: 2018-06-19
Agency: Department of Health and Human Services, National Institutes of Health
Ryan White HIV/AIDS Program Parts A and B Integrated HIV Planning Implementation Cooperative Agreement to John Snow, Inc. (JSI), U69HA30144
Document Number: 2018-13121
Type: Notice
Date: 2018-06-19
Agency: Department of Health and Human Services, Health Resources and Services Administration
This noncompetitive supplement award to JSI will support and strengthen current Ryan White HIV/AIDS Program (RWHAP) Part A and Part B priority setting and resource allocation processes to ensure people living with HIV are linked to care, remain engaged in care, and achieve viral suppression.
Notice of Meeting
Document Number: 2018-13116
Type: Notice
Date: 2018-06-19
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2018-13098
Type: Notice
Date: 2018-06-19
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.
Proposed Information Collection Activity; Comment Request
Document Number: 2018-13060
Type: Notice
Date: 2018-06-19
Agency: Department of Health and Human Services, Administration for Children and Families
Advisory Committee on Breast Cancer in Young Women (ACBCYW)
Document Number: 2018-13047
Type: Notice
Date: 2018-06-18
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 Advisory Committee on Breast Cancer in Young Women (ACBCYW). This meeting is open to the public, limited only by audio phone lines (100 audio lines available and 100 web conference lines available).
Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous Manifestations; Draft Guidance for Industry; Availability
Document Number: 2018-12976
Type: Notice
Date: 2018-06-18
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 ``Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous Manifestations.'' The purpose of this draft guidance is to assist sponsors with the development of drugs for treatment or prevention of the serious cutaneous manifestations of the heterogeneous group of disorders collectively known as epidermolysis bullosa (EB). There is an unmet medical need for EB patients due to the paucity of effective treatment options.
S9 Nonclinical Evaluation for Anticancer Pharmaceuticals-Questions and Answers; International Council for Harmonisation; Guidance for Industry; Availability
Document Number: 2018-12975
Type: Notice
Date: 2018-06-18
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 ``S9 Nonclinical Evaluation for Anticancer PharmaceuticalsQuestions and Answers.'' The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. The guidance consists of questions and answers that were developed to provide additional clarity about anticancer pharmaceutical development described in the ICH guidance ``S9 Nonclinical Evaluation for Anticancer Pharmaceuticals'' that was published in 2010 (ICH S9 (2010)), as well as to continue progress in the 3Rs of Reduction, Refinement, and Replacement in the use of animals.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-12972
Type: Notice
Date: 2018-06-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-12971
Type: Notice
Date: 2018-06-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Technical Specifications for Electronic Submissions; Establishment of a Public Docket
Document Number: 2018-12969
Type: Notice
Date: 2018-06-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is establishing a public docket to receive information, recommendations, and comments on matters related to the Agency's publication of technical specifications, which explain, clarify, and define the specific use of data standards in new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and certain investigational new drug applications (INDs) to the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). This docket is intended for general comments related to technical specifications that are not specific to documents or issues that are the subject of other dockets, or for comments specific to electronic submission guidances.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Formal Meetings Between the Food and Drug Administration and Biosimilar Biological Product Sponsors or Applicants
Document Number: 2018-12968
Type: Notice
Date: 2018-06-18
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 formal meetings between FDA and biosimilar biological product sponsors or applicants.
Foods Produced Using Animal Cell Culture Technology; Public Meeting; Request for Comments
Document Number: 2018-12939
Type: Notice
Date: 2018-06-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing a public meeting entitled ``Foods Produced Using Animal Cell Culture Technology.'' FDA is holding the public meeting to provide the public with an opportunity to provide comments related to the production of foods using animal cell culture technology.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2018-12921
Type: Notice
Date: 2018-06-18
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-12920
Type: Notice
Date: 2018-06-18
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Intent To Award a Single-Source Supplement
Document Number: 2018-12978
Type: Notice
Date: 2018-06-15
Agency: Department of Health and Human Services
Center for Substance Abuse Treatment; Notice of Meeting
Document Number: 2018-12897
Type: Notice
Date: 2018-06-15
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply-Chain Program; Draft Guidance for Industry; Availability
Document Number: 2018-12894
Type: Notice
Date: 2018-06-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry #246 entitled ``Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply-Chain Program.'' This draft guidance document, when finalized, will help animal food facilities comply with the requirements for the supply-chain program under our regulation ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals.''
The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels; Guidance for Industry; Availability
Document Number: 2018-12867
Type: Rule
Date: 2018-06-15
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 final guidance for industry entitled ``The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels; Guidance for Industry.'' The guidance identifies eight specific, additional isolated or synthetic non-digestible carbohydrates that we intend to add to our regulatory definition of ``dietary fiber'' through our regular rulemaking process. In the interim, the guidance also advises manufacturers of our policy for when one or more of these eight non-digestible carbohydrates, present in a food, are included in the declared amount of ``dietary fiber,'' and for the use of a caloric value for polydextrose of 1 kilocalorie per gram (kcal/g).
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2018-12865
Type: Notice
Date: 2018-06-15
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2018-12864
Type: Notice
Date: 2018-06-15
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Medicare Program; Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program; Correction
Document Number: 2018-12843
Type: Rule
Date: 2018-06-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical and typographical errors that appeared in the final rule published in the Federal Register on April 16, 2018 titled ``Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program.''
Medicare and Medicaid Programs: Application From the Community Health Accreditation Partner for Continued CMS Approval of Its Hospice Accreditation Program
Document Number: 2018-12840
Type: Notice
Date: 2018-06-15
Agency: Department of Health and Human Services, Centers for Medicare and Medicaid Services
This proposed notice acknowledges the receipt of an application from the Community Health Accreditation Partner (CHAP) for continued recognition as a national accrediting organization for hospices that wish to participate in the Medicare or Medicaid programs.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-12839
Type: Notice
Date: 2018-06-15
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of Exclusive Patent Commercialization License: Streptococcus Pneumonia PSAA Peptide for Treatment of Sepsis and Infection
Document Number: 2018-12838
Type: Notice
Date: 2018-06-15
Agency: Department of Health and Human Services, National Institutes of Health
The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, on behalf of the Centers for Disease Control and Prevention, Department of Health and Human Services, is contemplating the grant of an exclusive patent commercialization license to The University of Liverpool, located in Liverpool, UK, to practice the inventions embodied in the patent applications listed in the Supplementary Information section of this notice.
National Cancer Institute; Amended Notice of Meeting
Document Number: 2018-12837
Type: Notice
Date: 2018-06-15
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-12836
Type: Notice
Date: 2018-06-15
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee-August 22, 2018
Document Number: 2018-12831
Type: Notice
Date: 2018-06-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, August 22, 2018. This meeting will focus on the state of evidence on Chimeric Antigen Receptor (CAR) T-cell therapies that are approved by the Food and Drug Administration (FDA). We are seeking the MEDCAC's recommendations regarding collection of patient reported outcomes (PRO) in cancer clinical studies. The MEDCAC will specifically focus on appraisal of evidence-based PRO assessments to provide information that impacts patients, their providers, and caregivers after a CAR T-cell therapy intervention for the patient's cancer. This meeting is open to the public in accordance with the Federal Advisory Committee Act.
Medical Devices; Gastroenterology-Urology Devices; Classification of the Fluid Jet System for Prostate Tissue Removal
Document Number: 2018-12829
Type: Rule
Date: 2018-06-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the fluid jet system for prostate tissue removal 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 fluid jet system for prostate tissue removal'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.
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; State Councils on Developmental Disabilities-Annual Program Performance Report (PPR) (OMB Control Number-0985-0033)
Document Number: 2018-12826
Type: Notice
Date: 2018-06-15
Agency: Department of Health and Human Services
The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-day notice collects comments on the information collection requirements related to the State Councils on Developmental DisabilitiesAnnual Program Performance Report (PPR) [Proposed Extension with Changes of a Currently Approved Collection (ICR Rev)].
Coronary, Peripheral, and Neurovascular Guidewires-Performance Tests and Recommended Labeling; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2018-12825
Type: Notice
Date: 2018-06-15
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 ``Coronary, Peripheral, and Neurovascular GuidewiresPerformance Tests and Recommended Labeling.'' This draft guidance provides recommendations for the information and testing that should be included in premarket submissions for guidewires intended for use in the coronary, peripheral, and neurovasculature. This draft guidance is not final nor is it in effect at this time.
Intravascular Catheters, Wires, and Delivery Systems With Lubricious Coatings-Labeling Considerations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2018-12824
Type: Notice
Date: 2018-06-15
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 ``Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings Labeling Considerations.'' This draft guidance addresses labeling considerations for devices containing lubricious coatings that are used in the vasculature. The purpose of this draft guidance is to provide recommendations for information to be included in device labeling, as submitted in premarket applications (PMAs) or premarket notification submissions (510(k)s) for class III and class II devices, to enhance the consistency of information across these product areas as well as to promote the safe use of these devices in clinical settings. This draft guidance is not final nor is it in effect at this time.
Final National Occupational Research Agenda for Agriculture, Forestry, and Fishing
Document Number: 2018-12821
Type: Notice
Date: 2018-06-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
NIOSH announces the availability of the final National Occupational Research Agenda for Agriculture, Forestry, and Fishing.
Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Electrosurgical Clip Cutting System
Document Number: 2018-12794
Type: Rule
Date: 2018-06-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the endoscopic electrosurgical clip cutting system 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 endoscopic electrosurgical clip cutting system'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.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Zika Virus Pilot Project, OMB No. 0906-xxxx-NEW
Document Number: 2018-12782
Type: Notice
Date: 2018-06-14
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-12767
Type: Notice
Date: 2018-06-14
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 ``Ambulatory Surgery Center Survey on Patient Safety Culture Database.'' This proposed information collection was previously published in the Federal Register on March 14th, 2018 and allowed 60 days for public comment. AHRQ received no substantive comments from members of the public. The purpose of this notice is to allow an additional 30 days for public comment.
Ferring Pharmaceuticals, Inc.; Withdrawal of Approval of Two Abbreviated New Drug Applications
Document Number: 2018-12762
Type: Notice
Date: 2018-06-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of two abbreviated new drug applications (ANDAs) from Ferring Pharmaceuticals, Inc. (Ferring). Ferring notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis; Draft Guidance for Industry; Availability
Document Number: 2018-12761
Type: Notice
Date: 2018-06-14
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 ``Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis.'' This draft guidance provides nonclinical and clinical recommendations specific to the development of systemic drug products, with a focus on long-acting systemic drug products, regulated within the Center for Drug Evaluation and Research (CDER) at FDA for the prevention of sexually acquired human immunodeficiency virus-1 (HIV-1) infection.
Medical Devices; Immunology and Microbiology Devices; Classification of the Brain Trauma Assessment Test
Document Number: 2018-12760
Type: Rule
Date: 2018-06-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the brain trauma assessment test 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 brain trauma assessment test'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.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-12735
Type: Notice
Date: 2018-06-14
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Meeting
Document Number: 2018-12730
Type: Notice
Date: 2018-06-14
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary and Integrative Health; Notice of Meeting
Document Number: 2018-12729
Type: Notice
Date: 2018-06-14
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2018-12728
Type: Notice
Date: 2018-06-14
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-12727
Type: Notice
Date: 2018-06-14
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Intent To Prepare an Environmental Impact Statement, Public Scoping Meeting, and Request for Comments; Acquisition of Site for Development of a Replacement Underground Safety Research Program Facility for the Centers for Disease Control and Prevention/National Institute for Occupational Safety and Health (CDC/NIOSH) in Mace, West Virginia
Document Number: 2018-12660
Type: Notice
Date: 2018-06-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS), in cooperation with the General Services Administration (GSA), announces its intent to prepare an Environmental Impact Statement (EIS) to analyze and assess the environmental impacts of the proposed acquisition of a site in Mace, West Virginia, and the development of this site into a replacement of the National Institute for Occupational Safety and Health (NIOSH) Underground Safety Research Program facility (Proposed Action). The current acquisition and development would replace the former Lake Lynn Experimental Mine in Fayette County, Pennsylvania and would support research programs focused on miner health and safety issues. The site being considered for acquisition and development includes 461.35 acres located off of U.S. Route 219 in Randolph and Pocahontas Counties near Mace, West Virginia. This notice is pursuant to the requirements of the National Environmental Policy Act of 1969 (NEPA) as implemented by the Council on Environmental Quality (CEQ) Regulations (40 CFR parts 1500-1508). CDC, in cooperation with GSA, also intends to initiate consultation, as required by Section 106 of the National Historic Preservation Act (NHPA), to evaluate the potential effects, if any, of the Proposed Action on historic properties. Following the scoping meeting, a Draft EIS will be prepared and circulated for public comment. CDC is the lead federal agency for this Proposed Action.
Request for Data and Information on Technologies Used To Detect and Measure Botulinum Neurotoxin
Document Number: 2018-12726
Type: Notice
Date: 2018-06-13
Agency: Department of Health and Human Services, National Institutes of Health
The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) requests available data and information on approaches and/or technologies currently used to detect and measure botulinum neurotoxin (BoNT). Submitted information will be used to assess the state of the science and determine technical needs for non-animal test methods that are used to detect the presence of BoNT and measure potency of BoNT preparations.
National Institute of Environmental Health Sciences; Notice of Closed Meetings
Document Number: 2018-12675
Type: Notice
Date: 2018-06-13
Agency: Department of Health and Human Services, National Institutes of Health
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