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

Results 101 - 150 of 268
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.
Medicare Program; Request for Information on Hospital and Vendor Readiness for Electronic Health Records Hospital Inpatient Quality Data Reporting; Extension of Comment Period
Document Number: 2013-01142
Type: Notice
Date: 2013-01-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice extends the comment period for a request for information (RFI) which was published in the January 3, 2013 Federal Register (78 FR 308). The RFI requests that hospitals, electronic health record (EHR) vendors, and other interested parties respond to questions regarding their readiness to conduct electronic reporting of certain patient-level data under the Hospital Inpatient Quality Reporting (IQR) Program using the Quality Reporting Document Architecture (QRDA) Category I. The comment period for the RFI, which would have ended on January 22, 2013, is extended to February 1, 2013.
Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water
Document Number: 2013-01032
Type: Notice
Date: 2013-01-18
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 invites comments on the procedure by which both domestic and foreign bottled water manufacturers that sell bottled water in the United States maintain records of microbiological testing and corrective measures, in addition to existing recordkeeping requirements.
Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements
Document Number: 2013-01031
Type: Notice
Date: 2013-01-18
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. 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 invites comments on the information collection provisions of the regulation requiring manufacturers, packers, and distributors of dietary supplements to notify us that they are marketing a dietary supplement product that bears on its label or in its labeling a statement provided for in the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2013-01022
Type: Notice
Date: 2013-01-18
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Assistant Secretary for Health (OASH), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting that ICR to OMB, OASH seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Effective Date of Requirement for Premarket Approval for Two Class III Preamendments Devices
Document Number: 2013-01006
Type: Proposed Rule
Date: 2013-01-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following two class III preamendments devices: Hip joint metal/metal semi- constrained, with a cemented acetabular component, prosthesis; and hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis. The Agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements and the benefits to the public from the use of the devices. In addition, FDA is announcing the opportunity for interested persons to request that the Agency change the classification of any of the aforementioned devices based on new information. This action implements certain statutory requirements.
Update of NIOSH Nanotechnology Strategic Plan for Research and Guidance
Document Number: 2013-00994
Type: Notice
Date: 2013-01-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) seeks comment on the types of hazard identification and risk management research that should be considered for updating the NIOSH FY2013-FY2016 nanotechnology strategic plan. This draft strategic plan (Protecting the Nanotechnology Workforce: NIOSH Nanotechnology Research and Guidance Strategic Plan 2013-2016) can be found in Docket CDC-2013-0001 at http://www.regulations.gov.
Notice of Development of Set 26 Toxicological Profiles
Document Number: 2013-00991
Type: Notice
Date: 2013-01-18
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
This notice announces the development of Set 26 Toxicological Profiles, which will consist of three updated profiles and two new profiles. Draft for Public Comment versions of these profiles will be available to the public on or about October 17, 2013. Electronic access to these documents will be available at the ATSDR Web site: http:// www.atsdr.cdc.gov/toxprofiles/index.asp.
Office for State, Tribal, Local and Territorial Support (OSTLTS) Meeting; Correction
Document Number: 2013-00989
Type: Notice
Date: 2013-01-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This document corrects a notice that was published in the Federal Register on January 7, 2013 (78 FR 949-950). The 10th Biannual Tribal Consultation session has been postponed to coincide with the summer 2013 meetings; the dates will be announced once they are determined. The Tribal Advisory Committee Meeting will be extended and held February 5, 6, and 7, 2013, from 8:00 a.m.-4:30 p.m.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-00988
Type: Notice
Date: 2013-01-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-00987
Type: Notice
Date: 2013-01-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Meeting of the National Vaccine Advisory Committee
Document Number: 2013-00950
Type: Notice
Date: 2013-01-18
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public. Pre-registration is required for both public attendance and comment. Individuals who wish to attend the meeting and/or participate in the public comment session should register at http://www.hhs.gov/nvpo/nvac, email nvpo@hhs.gov, or call 202-690-5566 and provide name, organization, and email address.
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 2013-00925
Type: Notice
Date: 2013-01-17
Agency: Department of Health and Human Services
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Los Alamos National Laboratory (LANL), in Los Alamos, New Mexico, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On December 7, 2012, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 2013-00924
Type: Notice
Date: 2013-01-17
Agency: Department of Health and Human Services
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from Oak Ridge National Laboratory (X-10), in Oak Ridge, Tennessee, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On December 7, 2012, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 2013-00923
Type: Notice
Date: 2013-01-17
Agency: Department of Health and Human Services
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Nuclear Metals, Inc. facility in West Concord, Massachusetts, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On December 7, 2012, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 2013-00920
Type: Notice
Date: 2013-01-17
Agency: Department of Health and Human Services
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Mound Plant, in Miamisburg, Ohio, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On December 7, 2012, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2013-00885
Type: Notice
Date: 2013-01-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-00884
Type: Notice
Date: 2013-01-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2013-00883
Type: Notice
Date: 2013-01-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-00882
Type: Notice
Date: 2013-01-17
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2013-00881
Type: Notice
Date: 2013-01-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Meetings
Document Number: 2013-00880
Type: Notice
Date: 2013-01-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meetings
Document Number: 2013-00879
Type: Notice
Date: 2013-01-17
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of a Co-Exclusive License: Adenovirus-Based Controls and Calibrators for Molecular Diagnostics of Infectious Disease Agents
Document Number: 2013-00878
Type: Notice
Date: 2013-01-17
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of a worldwide co-exclusive license, to practice the inventions embodied in US patent 6,013,638 (HHS Reference E-129-1991/0- US-03), issued January 11, 2000 and entitled ``Adenovirus Comprising Deletions on the E1A, E1B And E3 Regions for Transfer of Genes to the Lung'', and US patent 6,136,594 (HHS Reference E-129-1991/1- US-03), issued October 24, 2000, and entitled ``Replication Deficient Recombinant Adenovirus Vector'' to Life Technologies Corporation (LTC) of Carlsbad, California. The United States of America is an assignee of the rights of the above inventions. The field of use may be limited to the ``use of adenovirus-based recombinant constructs as controls and calibrators for molecular diagnostics for infectious disease agents.''
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-00860
Type: Notice
Date: 2013-01-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2013-00858
Type: Notice
Date: 2013-01-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Generic Drug User Fee-Active Pharmaceutical Ingredient and Finished Dosage Form Facility Fee Rates for Fiscal Year 2013
Document Number: 2013-00851
Type: Notice
Date: 2013-01-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the rate for the generic drug active pharmaceutical ingredient (API) and finished dosage form (FDF) facilities user fees for fiscal year (FY) 2013. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Generic Drug User Fee Amendments of 2012 (GDUFA), enacted the Food and Drug Administration Safety and Innovation Act, as further amended by the FDA User Fee Corrections Act of 2012, authorizes FDA to assess and collect user fees for certain applications and supplements associated with human generic drug products, on applications in the backlog as of October 1, 2012, on finished dosage form (FDF) and active pharmaceutical ingredient (API) facilities, and on Type II API drug master files (DMF) to be made available for reference. GDUFA directs FDA to establish each year the generic drug user fee rates for the upcoming year. In the first year of GDUFA (FY 2013), some rates will be published in separate Federal Register notices because of the timing specified in the statute. Each year thereafter the GDUFA fee rates will be published 60 days before the start of the fiscal year. This document establishes the FY 2013 rate for API and FDF facility fees. These fees are due on March 4, 2013.
Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm; Availability
Document Number: 2013-124
Type: Proposed Rule
Date: 2013-01-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of, and requesting comment on, a document entitled ``Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co- Located on a Farm'' (the draft RA). The purpose of the draft RA is to provide a science-based risk analysis of those activity/food combinations that would be considered low risk. FDA conducted this draft RA to satisfy requirements of the FDA Food Safety Modernization Act (FSMA) to conduct a science-based risk analysis and to consider the results of that analysis in rulemaking that is required by FSMA. Elsewhere in this issue of the Federal Register, FDA is using the results of the draft RA to propose to exempt food facilities that are small or very small businesses that are engaged only in specific types of on-farm manufacturing, processing, packing, or holding activities identified in the draft RA as low-risk activity/food combinations from the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for hazard analysis and risk-based preventive controls.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-00806
Type: Notice
Date: 2013-01-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Submission of Food and Drug Administration Adverse Event Reports and Other Safety Information Using the Electronic Submission Gateway and the Safety Reporting Portal
Document Number: 2013-00761
Type: Notice
Date: 2013-01-16
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 (the PRA).
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-00755
Type: Notice
Date: 2013-01-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Government-Owned Inventions; Availability for Licensing
Document Number: 2013-00738
Type: Notice
Date: 2013-01-16
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.