Department of Health and Human Services September 4, 2018 – Federal Register Recent Federal Regulation Documents

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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