Department of Health and Human Services December 2, 2016 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-29011
Type: Notice
Date: 2016-12-02
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 any of the following subjects: 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: 2016-29007
Type: Notice
Date: 2016-12-02
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 any of the following subjects: 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.
Physiologically Based Pharmacokinetic Analyses-Format and Content; Draft Guidance for Industry; Availability
Document Number: 2016-28971
Type: Notice
Date: 2016-12-02
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 ``Physiologically Based Pharmacokinetic AnalysesFormat and Content.'' This guidance recommends to drug sponsors the format and content for submitting physiologically based pharmacokinetic (PBPK) analyses to FDA to enable efficient and consistent review.
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: 2016-28940
Type: Notice
Date: 2016-12-02
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). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; TRESIBA
Document Number: 2016-28939
Type: Notice
Date: 2016-12-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for TRESIBA 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; OPDIVO
Document Number: 2016-28917
Type: Notice
Date: 2016-12-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for OPDIVO 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 biological product.
Determination of Regulatory Review Period for Purposes of Patent Extension; TRUMENBA
Document Number: 2016-28916
Type: Notice
Date: 2016-12-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for TRUMENBA 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 biological product.
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2016-28902
Type: Notice
Date: 2016-12-02
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: 2016-28901
Type: Notice
Date: 2016-12-02
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-28899
Type: Notice
Date: 2016-12-02
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 collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection entitled ``Understanding Relationship Dynamics and Conflict Survey.'' CDC will use the information collected to ascertain which factors or groups of factors may influence violence perpetration that occurs within adult intimate partner relationships.
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