Department of Health and Human Services December 27, 2013 – Federal Register Recent Federal Regulation Documents

Ryan White HIV/AIDS Program Part C Early Intervention Services Grant Under the Ryan White HIV/AIDS Program
Document Number: 2013-31120
Type: Notice
Date: 2013-12-27
Agency: Department of Health and Human Services, Health Resources and Services Administration
To prevent a lapse in comprehensive primary care services for persons living with HIV/AIDS, HRSA will provide a one-time noncompetitive Ryan White HIV/AIDS Program Part C award to Our Lady of the Lake Regional Medical Center, Inc. (OLOL), Baton Rouge, Louisiana.
Notice of Publication of a Draft of the Revised Guidebook for the National Practitioner Data Bank
Document Number: 2013-31119
Type: Notice
Date: 2013-12-27
Agency: Department of Health and Human Services, Health Resources and Services Administration
The National Practitioner Data Bank (NPDB) announces the release of a draft of the revised user Guidebook. The public is able to request a copy of the draft of the revised Guidebook and submit comments to the NPDB by the deadline below. The revised Guidebook includes expanded and improved reporting and querying examples; useful tables explaining Data Bank policies; and live links to statutes, regulations, and the Web site. The NPDB is a confidential information clearinghouse created by Congress intended to facilitate a comprehensive review of the professional credentials of health care practitioners, health care entities, providers, and suppliers. The Guidebook is a policy manual that serves as an essential reference for Data Bank users to clarify legislative and regulatory requirements through the use of reporting and querying examples, explanations, definitions, and frequently asked questions (FAQs). The new Guidebook incorporates legislative and regulatory changes adopted since its last edition, including the merger of the NPDB with the Healthcare Integrity and Protection Data Bank. Once the comments have been reviewed, a final version of the revised Guidebook will be made available and will replace previous Guidebooks. For information on how to request a PDF copy of the draft Guidebook and instructions on how to submit comments, visit the NPDB Web site at: http://www.npdb.hrsa.gov/news/news.jsp.
Privacy Act of 1974; System of Records Notice
Document Number: 2013-31118
Type: Notice
Date: 2013-12-27
Agency: Department of Health and Human Services
In accordance with the requirements of the Privacy Act of 1974, as amended (5 U.S.C. 552a), HHS is altering an existing system of records, ``National Disaster Medical System (NDMS) Patient Treatment and Tracking,'' system number 09-90-0040. The system of records was originally published June 26, 2007 (see 72 FR 35052) and previously revised March 27, 2008 (see 73 FR 16307). The alterations include: (1) Changing the system name to ``National Disaster Medical System (NDMS) Disaster Medical Information Suite (DMIS);'' (2) revising the categories of individuals to reflect that patients may include disaster workers and others who are provided medical countermeasures; (3) dividing the records into three categories (patient treatment, patient tracking, and veterinarian treatment) instead of two (patient treatment and veterinarian treatment); (4) adding, as a purpose for which information from this system is used, that the system provides HHS' NDMS claims processing system with records needed to reimburse NDMS providers for their services; (5) revising the first routine use to include these additional disclosure recipients: state and city governmental agencies, Non-Governmental Organizations (NGOs; e.g., American Red Cross), and hospitals that provide care to NDMS patients; and (6) adding one new routine use, pertaining to security breach response.
Criteria for a Recommended Standard; Occupational Exposure to Heat and Hot Environments; Draft Criteria Document Availability
Document Number: 2013-31066
Type: Notice
Date: 2013-12-27
Agency: Department of Health and Human Services, Centers for Disease Control and Prevention (cdc)
The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention announces the availability of a draft Criteria Document entitled Criteria for a Recommended Standard: Occupational Exposure to Heat and Hot Environments for public comment. To view the notice and related materials, visit http://www.regulations.gov and enter CDC-2013-0025 in the search field and click ``Search.'' Comments may be provided to the NIOSH docket, as well as given orally at the meeting.
Issuance of Final Guidance Publication
Document Number: 2013-31063
Type: Notice
Date: 2013-12-27
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), announces the availability of the following publication: ``Protecting the Nanotechnology Workforce: NIOSH Nanotechnology Research and Guidance Strategic Plan 2013-2016'' [NIOSH 2014-106].
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2013-31053
Type: Notice
Date: 2013-12-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2013-31052
Type: Notice
Date: 2013-12-27
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2013-31051
Type: Notice
Date: 2013-12-27
Agency: Department of Health and Human Services, National Institutes of Health
Center For Scientific Review; Notice of Closed Meetings
Document Number: 2013-31050
Type: Notice
Date: 2013-12-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2013-31049
Type: Notice
Date: 2013-12-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Meetings
Document Number: 2013-31048
Type: Notice
Date: 2013-12-27
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-31047
Type: Notice
Date: 2013-12-27
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-31016
Type: Notice
Date: 2013-12-27
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: 2013-31015
Type: Notice
Date: 2013-12-27
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; Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition
Document Number: 2013-30998
Type: Notice
Date: 2013-12-27
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
Document Number: 2013-30996
Type: Notice
Date: 2013-12-27
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-30994
Type: Notice
Date: 2013-12-27
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: Proposed Collection; Comment Request
Document Number: 2013-30990
Type: Notice
Date: 2013-12-27
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB); Correction
Document Number: 2013-30989
Type: Notice
Date: 2013-12-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects a date in the December 23, 2013, Federal Register notice (document identifier: CMS-10510) entitled ``Basic Health Program Report for Health Insurance Exchange Premium.''
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2013-30988
Type: Notice
Date: 2013-12-27
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for renewal of the approved information collection assigned OMB control number 0990-0162 scheduled to expire on January 31, 2014 Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2013-30983
Type: Notice
Date: 2013-12-27
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Subcommittee on Procedures Review, Advisory Board on Radiation and Worker Health (ABRWH), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2013-30930
Type: Notice
Date: 2013-12-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medicare and State Health Care Programs: Fraud and Abuse; Electronic Health Records Safe Harbor Under the Anti-Kickback Statute
Document Number: 2013-30924
Type: Rule
Date: 2013-12-27
Agency: Department of Health and Human Services, Office of Inspector General
In this final rule, the Office of Inspector General (OIG) amends the safe harbor regulation concerning electronic health records items and services, which defines certain conduct that is protected from liability under the Federal anti-kickback statute, section 1128B(b) of the Social Security Act (the Act). Amendments include updating the provision under which electronic health records software is deemed interoperable; removing the electronic prescribing capability requirement; extending the sunset provision until December 31, 2021; limiting the scope of protected donors to exclude laboratory companies; and clarifying the condition that prohibits a donor from taking any action to limit or restrict the use, compatibility, or interoperability of the donated items or services.
Medicare Program; Physicians' Referrals to Health Care Entities With Which They Have Financial Relationships: Exception for Certain Electronic Health Records Arrangements
Document Number: 2013-30923
Type: Rule
Date: 2013-12-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule revises the exception to the physician self- referral law that permits certain arrangements involving the donation of electronic health records items and services. Specifically, this final rule extends the expiration date of the exception to December 31, 2021, excludes laboratory companies from the types of entities that may donate electronic health records items and services, updates the provision under which electronic health records software is deemed interoperable, removes the electronic prescribing capability requirement, and clarifies the requirement prohibiting any action that limits or restricts the use, compatibility, or interoperability of donated items or services.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2013-30910
Type: Notice
Date: 2013-12-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2013-30909
Type: Notice
Date: 2013-12-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Subcommittee on Procedures Review, Advisory Board on Radiation and Worker Health (ABRWH), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2013-30908
Type: Notice
Date: 2013-12-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review
Document Number: 2013-30906
Type: Notice
Date: 2013-12-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Board of Scientific Counselors, National Center for Health Statistics
Document Number: 2013-30904
Type: Notice
Date: 2013-12-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute of Biomedical Imaging and Bioengineering; Amended Notice of Meeting
Document Number: 2013-30892
Type: Notice
Date: 2013-12-27
Agency: Department of Health and Human Services, National Institutes of Health
Center For Scientific Review; Notice of Closed Meeting
Document Number: 2013-30891
Type: Notice
Date: 2013-12-27
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Meeting
Document Number: 2013-30890
Type: Notice
Date: 2013-12-27
Agency: Department of Health and Human Services, National Institutes of Health
Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Correction and Extension of Comment Period
Document Number: 2013-30881
Type: Proposed Rule
Date: 2013-12-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting, and extending the comment period for, the proposed rule that appeared in the Federal Register of November 13, 2013. In the proposed rule, FDA requested comments on the proposal to revise and clarify procedures for application holders of an approved drug or biological product to change the product labeling to reflect certain types of newly acquired information in advance of FDA's review of the change. The proposed rule published without a reference or a link to the accompanying Regulatory Impact Analysis. The Agency is taking this action to correct this omission and to extend the comment period in response to requests for an extension to allow interested persons additional time to submit comments on the proposed rule.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products
Document Number: 2013-30880
Type: Notice
Date: 2013-12-27
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 request regarding the guidance for industry and FDA staff entitled ``Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products.''
Withdrawal of Approval of New Animal Drug Applications; Roxarsone
Document Number: 2013-30838
Type: Rule
Date: 2013-12-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal approval of five new animal drug applications (NADAs) for roxarsone oral dosage form products at the sponsor's request because the products are no longer manufactured or marketed.
Withdrawal of Approval of New Animal Drug Applications; Roxarsone
Document Number: 2013-30837
Type: Rule
Date: 2013-12-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing approval of five new animal drug applications (NADAs) for roxarsone oral dosage form products at the sponsor's request because the products are no longer manufactured or marketed.
Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers
Document Number: 2013-30724
Type: Proposed Rule
Date: 2013-12-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would establish national emergency preparedness requirements for Medicare- and Medicaid-participating providers and suppliers to ensure that they adequately plan for both natural and man-made disasters, and coordinate with federal, state, tribal, regional, and local emergency preparedness systems. It would also ensure that these providers and suppliers are adequately prepared to meet the needs of patients, residents, clients, and participants during disasters and emergency situations. We are proposing emergency preparedness requirements that 17 provider and supplier types must meet to participate in the Medicare and Medicaid programs. Since existing Medicare and Medicaid requirements vary across the types of providers and suppliers, we are also proposing variations in these requirements. These variations are based on existing statutory and regulatory policies and differing needs of each provider or supplier type and the individuals to whom they provide health care services. Despite these variations, our proposed regulations would provide generally consistent emergency preparedness requirements, enhance patient safety during emergencies for persons served by Medicare- and Medicaid-participating facilities, and establish a more coordinated and defined response to natural and man- made disasters.
Medicare Program; Right of Appeal for Medicare Secondary Payer Determination Relating to Liability Insurance (Including Self-Insurance), No Fault Insurance, and Workers' Compensation Laws and Plans
Document Number: 2013-30661
Type: Proposed Rule
Date: 2013-12-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would implement provisions of the Strengthening Medicare and Repaying Taxpayers Act of 2012 (SMART Act) which require us to provide a right of appeal and an appeal process for liability insurance (including self-insurance), no-fault insurance, and workers' compensation laws or plans when Medicare pursues a Medicare Secondary Payer (MSP) recovery claim directly from the liability insurance (including self-insurance), no fault insurance, or workers' compensation law or plan.
Solicitation of New Safe Harbors and Special Fraud Alerts
Document Number: 2013-30429
Type: Proposed Rule
Date: 2013-12-27
Agency: Department of Health and Human Services, Office of Inspector General
In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), this annual notice solicits proposals and recommendations for developing new and modifying existing safe harbor provisions under the Federal anti-kickback statute (section 1128B(b) of the Social Security Act), as well as developing new OIG Special Fraud Alerts.