Department of Health and Human Services October 14, 2016 – Federal Register Recent Federal Regulation Documents

Medicare Program; Explanation of FY 2004 Outlier Fixed-Loss Threshold as Required by Court Rulings; Correction
Document Number: 2016-24917
Type: Rule
Date: 2016-10-14
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects a technical error that appeared in the document published in the Federal Register on January 22, 2016 entitled ``Medicare Program; Explanation of FY 2004 Outlier Fixed-Loss Threshold as Required by Court Rulings.''
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-24910
Type: Notice
Date: 2016-10-14
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 Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-24846
Type: Notice
Date: 2016-10-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-24845
Type: Notice
Date: 2016-10-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Evaluation and Initial Assessment of HRSA Teaching Health Centers
Document Number: 2016-24843
Type: Notice
Date: 2016-10-14
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 (Section 3506(c)(2)(A) 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.
Submission for OMB Review; Comment Request
Document Number: 2016-24829
Type: Notice
Date: 2016-10-14
Agency: Department of Health and Human Services, Administration for Children and Families
Submission for OMB Review; Comment Request
Document Number: 2016-24824
Type: Notice
Date: 2016-10-14
Agency: Department of Health and Human Services, Administration for Children and Families
Advisory Committee; Dermatologic and Ophthalmic Drugs Advisory Committee, Renewal
Document Number: 2016-24816
Type: Notice
Date: 2016-10-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the renewal of the Dermatologic and Ophthalmic 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 Dermatologic and Ophthalmic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until October 7, 2018.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2016-24814
Type: Notice
Date: 2016-10-14
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: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) 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: 2016-24813
Type: Notice
Date: 2016-10-14
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: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Submission for OMB Review; 30-Day Comment Request NCI's Center for Cancer Training Application Form for Graduate Student Recruitment Program (National Cancer Institute)
Document Number: 2016-24812
Type: Notice
Date: 2016-10-14
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on August 2, 2016, page 50713 (81 FR 50713) and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Advisory Committee; Antimicrobial Drugs Advisory Committee, Renewal
Document Number: 2016-24810
Type: Notice
Date: 2016-10-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the renewal of the Antimicrobial 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 Antimicrobial Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until October 7, 2018.
Advisory Committee on Heritable Disorders in Newborns and Children
Document Number: 2016-24808
Type: Notice
Date: 2016-10-14
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463, codified at 5 U.S.C. App.), notice is hereby given that a meeting is scheduled for the Advisory Committee on Heritable Disorders in Newborns and Children. This meeting will be open to the public but advance registration is required to ensure sufficient webinar capacity. The registration link is https://www.blsmeetings.net/ achdncnovember2016/. The registration deadline is Wednesday, November 2, 2016, 11:59 p.m. Eastern Time.
CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment
Document Number: 2016-24807
Type: Notice
Date: 2016-10-14
Agency: Department of Health and Human Services, Health Resources and Service Administration
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given that a meeting is scheduled for the Centers for Disease Control and Prevention (CDC)/ HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment. This meeting will be open to the public. Information about the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment and the agenda for this meeting can be obtained by contacting LCDR Holly Berilla at (301) 443-9965 or hberilla@hrsa.gov.
Software as a Medical Device: Clinical Evaluation; International Medical Device Regulators Forum; Draft Guidance for Industry; Availability
Document Number: 2016-24805
Type: Notice
Date: 2016-10-14
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 entitled ``Software as a Medical Device (SaMD): Clinical Evaluation.'' The draft guidance was prepared under the auspices of the International Medical Device Regulators Forum (IMDRF), formerly the Global Harmonization Task Force. The draft guidance pertains to the conduct of clinical evaluation of Software as a Medical Device (SaMD) and focuses on the general principles of clinical evaluation, which includes establishing the scientific validity, clinical performance, and analytical validity for a SaMD. The draft guidance is intended to provide globally harmonized principles of when and what type of clinical evaluation is appropriate based on the risk of the SaMD. This draft guidance is not final nor is it in effect at this time.
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meeting
Document Number: 2016-24804
Type: Notice
Date: 2016-10-14
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2016-24803
Type: Notice
Date: 2016-10-14
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-24802
Type: Notice
Date: 2016-10-14
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-24801
Type: Notice
Date: 2016-10-14
Agency: Department of Health and Human Services, National Institutes of Health