Department of Health and Human Services September 24, 2015 – Federal Register Recent Federal Regulation Documents

Health Insurance Marketplace, Medicare, Medicaid, and Children's Health Insurance Programs; Meeting of the Advisory Panel on Outreach and Education (APOE), October 7, 2015
Document Number: 2015-24304
Type: Notice
Date: 2015-09-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a meeting of the Advisory Panel on Outreach and Education (APOE) (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace, Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2015-24290
Type: Notice
Date: 2015-09-24
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Submission for OMB Review; Comment Request
Document Number: 2015-24270
Type: Notice
Date: 2015-09-24
Agency: Department of Health and Human Services, Administration for Children and Families
Meeting of the Secretary's Advisory Committee on Human Research Protections
Document Number: 2015-24264
Type: Notice
Date: 2015-09-24
Agency: Department of Health and Human Services
Pursuant to Section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. App 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP and the full meeting agenda will be posted on the SACHRP Web site at: https://www.dhhs.gov/ohrp/sachrp/mtgings/.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2015-24263
Type: Notice
Date: 2015-09-24
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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2015-24262
Type: Notice
Date: 2015-09-24
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; Submission for Office of Management and Budget Review; Comment Request; Electronic User Fee Payment Request Forms
Document Number: 2015-24228
Type: Notice
Date: 2015-09-24
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.
Interim Results of Study of Workload Volume and Full Costs Associated With Review of Biosimilar Biological Product Applications
Document Number: 2015-24227
Type: Notice
Date: 2015-09-24
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 interim results of a study of the workload volume and full costs associated with the process for the review of biosimilar biological product applications (interim report). This study was conducted by an independent consulting firm, and it fulfills FDA's statutory requirement under the first authorization of the Biosimilar User Fee Act of 2012 (BsUFA), which enables FDA to collect user fees for the review of biosimilar biological applications for fiscal years 2013 to 2017. This notice solicits comments on the interim report.
National Environmental Policy Act; Environmental Assessments for Tobacco Products; Categorical Exclusions
Document Number: 2015-24219
Type: Rule
Date: 2015-09-24
Agency: Food and Drug Administration, Department of Health and Human Services
In accordance with the National Environmental Policy Act of 1969 (NEPA) and the Council on Environmental Quality (CEQ) Regulations Implementing NEPA (CEQ regulations), the Food and Drug Administration (FDA or the Agency) is issuing a final rule to revise its NEPA implementing regulations to provide categorical exclusions for certain actions related to substantial equivalence (SE) reports, SE exemption requests, and tobacco product applications, and the rescission (order withdrawing an order) or suspension of orders regarding the marketing of tobacco products under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). FDA is also amending its NEPA implementing regulations to include tobacco products, where appropriate, in light of its new authority under the Tobacco Control Act.
Use of Investigational Tobacco Products; Draft Guidance for Industry and Investigators; Availability
Document Number: 2015-24218
Type: Notice
Date: 2015-09-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and investigators entitled ``Use of Investigational Tobacco Products.'' The draft guidance, when finalized, will describe FDA's current thinking regarding the definition of ``investigational tobacco product'' and will discuss the kind of information FDA intends to consider in making enforcement decisions regarding the use of investigational tobacco products until regulations governing the use of investigational tobacco products become effective or FDA provides written notice of its intent to change its enforcement policy.
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