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

Results 251 - 279 of 279
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2018-19316
Type: Notice
Date: 2018-09-06
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2018-19315
Type: Notice
Date: 2018-09-06
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review: Notice of Closed Meetings
Document Number: 2018-19314
Type: Notice
Date: 2018-09-06
Agency: Department of Health and Human Services, National Institutes of Health
Surgeon General's Call to Action: “Community Health and Prosperity”
Document Number: 2018-19313
Type: Notice
Date: 2018-09-06
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the opening of a docket to obtain comment on an upcoming Surgeon General's document/ Call to Action with a working title ``Community Health and Prosperity''. CDC is the lead agency to support the Office of the Surgeon General to publish a Call to Action that will be science-informed and actionable, outlining a conceptual framework with case examples and available evidence on the business case for investing in community health. The goal of the Call to Action is to: Clearly demonstrate that investments in community health have the potential to improve the health and prosperity of communities and issue a call to action to the private sector and local policy makers for investment in communities, unilaterally or as part of multi-sector or other consortium, to improve community health.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-19312
Type: Notice
Date: 2018-09-06
Agency: Department of Health and Human Services, National Institutes of Health
Draft Guidances Relating to the Development of Human Gene Therapy Products; Availability; Extension of Comment Period
Document Number: 2018-19303
Type: Notice
Date: 2018-09-06
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and Drug Administration (FDA or the Agency) is extending the comment period for the notices of availability for six draft guidance documents relating to the development of human gene therapy products that appeared in the Federal Register of July 12, 2018. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments and any new information.
Announcement of Intent To Establish the 2020 Dietary Guidelines Advisory Committee and Solicitation of Nominations for Membership
Document Number: 2018-19302
Type: Notice
Date: 2018-09-06
Agency: Department of Agriculture, Department of Health and Human Services
The Departments of Agriculture and Health and Human Services announce the intent to establish a Dietary Guidelines Advisory Committee and invite nominations for the Committee.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-19296
Type: Notice
Date: 2018-09-06
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 Capacity Building Assistance Program: Assessment and Quality Control. The purpose of this information collection is to assess how well the capacity building assistance (CBA) program meets the needs of health care staff from organizations funded directly or indirectly by the CDC, involved in HIV prevention service delivery. The program will assess customer satisfaction with CBA services and changes in capacity, knowledge, skills, and self-efficacy as a result of CBA service delivery.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-19295
Type: Notice
Date: 2018-09-06
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
The Agency for Toxic Substances and Disease Registry (ATSDR), 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 ``Prenatal Assessment of Environmental Risk (PAER)''. This web-based data collection will provide information on behavioral risks for environmental exposures for patients seeking preconception and prenatal care, and for their reproductive health care clinicians (RHCCs).
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-19294
Type: Notice
Date: 2018-09-06
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 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 ``Assessment of Outcomes Associated with the Preventive Health and Health Services Block Grant''. This assessment will assess select cross-cutting outputs and outcomes of the Preventive Health and Health Services Block Grant and demonstrates the utility of the grant on a national level.
Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2018-19249
Type: Notice
Date: 2018-09-06
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 ``Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions.'' This guidance document describes FDA's current approach to considering uncertainty in making benefit-risk determinations to support certain FDA premarket decisions for medical devicespremarket approval applications (PMAs), De Novo requests, and humanitarian device exemption (HDE) applications. This guidance document elaborates on the consideration of uncertainty as part of our overarching approach to a benefit-risk based framework that is intended to assure greater predictability, consistency, and efficiency through the application of least burdensome principles. This draft guidance also provides examples of how the principles for considering uncertainty could be applied in the context of clinical evidence and circumstances where greater uncertainty could be appropriate in premarket decisions, balanced by postmarket controlsPMAs for Breakthrough Devices and PMAs for devices for small patient populations. This draft guidance is not final nor is it in effect at this time.
Allergic Rhinitis: Developing Drug Products for Treatment; Guidance for Industry; Availability
Document Number: 2018-19248
Type: Notice
Date: 2018-09-06
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 guidance for industry entitled ``Allergic Rhinitis: Developing Drug Products for Treatment.'' The purpose of this guidance is to assist sponsors in the development of drug products for the treatment of allergic rhinitis in children and adults. The guidance addresses issues of trial design, effectiveness, and safety for new products being developed for the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR). This guidance incorporates the comments received for and finalizes the draft guidance of the same name issued on February 16, 2016.
Nonallergic Rhinitis: Developing Drug Products for Treatment; Guidance for Industry; Availability
Document Number: 2018-19247
Type: Notice
Date: 2018-09-06
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 guidance for industry entitled ``Nonallergic Rhinitis: Developing Drug Products for Treatment.'' The purpose of this guidance is to assist applicants of new drug applications and biologics license applications in developing drug products for the treatment of nonallergic rhinitis (NAR) in children and adults. This guidance incorporates the comments received and finalizes the draft guidance of the same name issued on February 16, 2016.
Privacy Act of 1974; Matching Program
Document Number: 2018-19189
Type: Notice
Date: 2018-09-05
Agency: Department of Health and Human Services
In accordance with subsection (e)(12) of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) is providing notice of a new computer matching program between CMS and the Department of the Treasury (Treasury), Internal Revenue Services (IRS), ``Verification of Household Income and Family Size for Insurance Affordability Programs and Exemptions.''
Submission for OMB Review; Comment Request
Document Number: 2018-19170
Type: Notice
Date: 2018-09-05
Agency: Department of Health and Human Services, Administration for Children and Families
National Advisory Council on Nurse Education and Practice; Notice of Public Meeting
Document Number: 2018-19168
Type: Notice
Date: 2018-09-05
Agency: Department of Health and Human Services, Health Resources and Service Administration
The National Advisory Council on Nurse Education and Practice (NACNEP) has scheduled a public meeting. Information about NACNEP and the agenda for this meeting can be found on the NACNEP website at https://www.hrsa.gov/advisory-committees/nursing/.
Submission for OMB Review; Comment Request
Document Number: 2018-19133
Type: Notice
Date: 2018-09-05
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for Quantitative Testing for the Development of FDA Communications
Document Number: 2018-19088
Type: Notice
Date: 2018-09-04
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on the creation of a new collection of information entitled ``Generic Clearance for Quantitative Testing for the Development of FDA Communications.''
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Labeling Regulations
Document Number: 2018-19086
Type: Notice
Date: 2018-09-04
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 Request; 30-Day Public Comment Request
Document Number: 2018-19084
Type: Notice
Date: 2018-09-04
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.
Notice of Closed Meeting
Document Number: 2018-19077
Type: Notice
Date: 2018-09-04
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
Document Number: 2018-19074
Type: Notice
Date: 2018-09-04
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 https:// www.samhsa.gov/workplace.
Advisory Committee; Cardiovascular and Renal Drugs Advisory Committee; Renewal
Document Number: 2018-19067
Type: Notice
Date: 2018-09-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the renewal of the Cardiovascular and Renal Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Cardiovascular and Renal Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until August 27, 2020.
Advisory Committee; Endocrinologic and Metabolic Drugs Advisory Committee, Renewal
Document Number: 2018-19066
Type: Notice
Date: 2018-09-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the renewal of the Endocrinologic and Metabolic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Endocrinologic and Metabolic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until August 27, 2020.
Physiologically Based Pharmacokinetic Analyses-Format and Content; Guidance for Industry; Availability
Document Number: 2018-19065
Type: Notice
Date: 2018-09-04
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 ``Physiologically Based Pharmacokinetic AnalysesFormat and Content.'' This guidance outlines the recommended format and content for a sponsor or applicant to submit physiologically based pharmacokinetic (PBPK) analyses to FDA to support applications including, but not limited to, investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs), or abbreviated new drug applications (ANDAs). This guidance does not address methodological considerations and best practices for the conduct of PBPK modeling and simulation or the appropriateness of PBPK analyses for a particular drug or a drug product.
Food for Human Consumption; Export Certificates; Food and Drug Administration Food Safety Modernization Act of 2011; Certification Fees
Document Number: 2018-19064
Type: Notice
Date: 2018-09-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the fees we will assess for issuing export certificates for food for human consumption, with the exception of dietary supplements, medical foods, and foods for special dietary use. The FDA Food Safety Modernization Act (FSMA) of 2011 authorizes us to charge fees to cover our costs associated with issuing export certificates for food. This notice provides the fee schedule for issuing these certificates and the basis for the fees. We have not previously exercised our FSMA authority to collect fees for export certificates issued for food for human consumption.
National Cancer Institute; Notice of Closed Meetings
Document Number: 2018-19051
Type: Notice
Date: 2018-09-04
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-19027
Type: Notice
Date: 2018-09-04
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 ``Medical Expenditure Panel Survey (MEPS) Household Component and the MEPS Medical Provider Component.'' This proposed information collection was previously published in the Federal Register on June 4, 2018 and allowed 60 days for public comment. AHRQ did not receive substantive comments from members of the public. The purpose of this notice is to allow an additional 30 days for public comment.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-19026
Type: Notice
Date: 2018-09-04
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 ``Nursing Home Survey on Patient Safety Culture Database.'' This proposed information collection was previously published in the Federal Register on May 31, 2018, and allowed 60 days for public comment. AHRQ received no substantive comments during this period. The purpose of this notice is to allow an additional 30 days for public comment.
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