Department of Health and Human Services January 22, 2013 – Federal Register Recent Federal Regulation Documents

Draft Report on Carcinogens Monographs for 1-Bromopropane and Cumene; Availability of Documents; Request for Comments; Notice of Meeting
Document Number: 2013-01242
Type: Notice
Date: 2013-01-22
Agency: Department of Health and Human Services, National Institutes of Health
Peer review meeting of the Draft Report on Carcinogens (RoC) Monographs for 1-Bromopropane and Cumene. These documents were prepared by the Office of the Report on Carcinogens (ORoC), Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS).
Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB); Extension of Comment Period
Document Number: 2013-01172
Type: Notice
Date: 2013-01-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice extends the comment period for a 60-day notice request for proposed information collection request associated with the notice [Document Identifier: CMS-10453] entitled ``The Medicare Advantage and Prescription Drug Program: Part C Explanation of Benefits CFR 422.111(b)(12)'' that was published in the November 26, 2012 (77 FR 70445) Federal Register. The comment period for the information collection request, which would have ended on January 25, 2013, is extended to February 1, 2013.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-01167
Type: Notice
Date: 2013-01-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Electronic Submission Process for Requesting Export Certificates From the Center for Devices and Radiological Health; Availability
Document Number: 2013-01164
Type: Notice
Date: 2013-01-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of an electronic submission process for requesting export certificates for products regulated by FDA's Center for Devices and Radiological Health (CDRH). The electronic process will help fulfill both the legislative and application time processing requirements set out by the FDA Export Reform and Enhancement Act of 1996 and the terms of clearance of the Office of Management and Budget approval (OMB control number 0910-0498) of the Form FDA 3613 series. The new eSubmitter process will complement the current paper-based process.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-01163
Type: Notice
Date: 2013-01-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
Document Number: 2013-01157
Type: Notice
Date: 2013-01-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of the Agency's regulations that require registration for domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States.
Submission for OMB Review; Comment Request
Document Number: 2013-01117
Type: Notice
Date: 2013-01-22
Agency: Department of Health and Human Services, Administration for Children and Families
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2013-01102
Type: Notice
Date: 2013-01-22
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meetings
Document Number: 2013-01101
Type: Notice
Date: 2013-01-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2013-01100
Type: Notice
Date: 2013-01-22
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-01099
Type: Notice
Date: 2013-01-22
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2013-01098
Type: Notice
Date: 2013-01-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2013-01097
Type: Notice
Date: 2013-01-22
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-01096
Type: Notice
Date: 2013-01-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2013-01095
Type: Notice
Date: 2013-01-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2013-01094
Type: Notice
Date: 2013-01-22
Agency: Department of Health and Human Services, National Institutes of Health
Draft Guidance for Industry and Food and Drug Administration Staff; Submissions for Postapproval Modifications to a Combination Product Approved Under Certain Marketing Applications; Availability
Document Number: 2013-01069
Type: Notice
Date: 2013-01-22
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 FDA staff entitled ``Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA.'' This draft guidance intends to provide the underlying principles to determine the type of marketing submission that may be required for postapproval changes to a combination product that is approved under one marketing application, i.e., a biologics license application (BLA), a new drug application (NDA), or a device premarket approval application (PMA).
Current Good Manufacturing Practice Requirements for Combination Products
Document Number: 2013-01068
Type: Rule
Date: 2013-01-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is issuing this regulation on the current good manufacturing practice (CGMP) requirements applicable to combination products. This rule is intended to promote the public health by clarifying which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products. In addition, the rule sets forth a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with CGMP requirements for ``single-entity'' and ``co-packaged'' combination products.
Medicaid, Children's Health Insurance Programs, and Exchanges: Essential Health Benefits in Alternative Benefit Plans, Eligibility Notices, Fair Hearing and Appeal Processes for Medicaid and Exchange Eligibility Appeals and Other Provisions Related to Eligibility and Enrollment for Exchanges, Medicaid and CHIP, and Medicaid Premiums and Cost Sharing
Document Number: 2013-00659
Type: Proposed Rule
Date: 2013-01-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Office of the Secretary
This proposed rule would implement provisions of the Patient Protection and Affordable Care Act of 2010 and the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act), and the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA). This proposed rule reflects new statutory eligibility provisions; proposes changes to provide states more flexibility to coordinate Medicaid and the Children's Health Insurance Program (CHIP) eligibility notices, appeals, and other related administrative procedures with similar procedures used by other health coverage programs authorized under the Affordable Care Act; modernizes and streamlines existing rules, eliminates obsolete rules, and updates provisions to reflect Medicaid eligibility pathways; revises the rules relating to the substitution of coverage to improve the coordination of CHIP coverage with other coverage; implements other CHIPRA eligibility-related provisions, including eligibility for newborns whose mothers were eligible for and receiving Medicaid or CHIP coverage at the time of birth; amends certain provisions included in the ``State Flexibility for Medicaid Benefit Packages'' final rule published on April 30, 2010; and implements specific provisions including eligibility appeals, notices, and verification of eligibility for qualifying coverage in an eligible employer-sponsored plan for Affordable Insurance Exchanges. This rule also proposes to update and simplify the complex Medicaid premiums and cost sharing requirements, to promote the most effective use of services, and to assist states in identifying cost sharing flexibilities.