Department of Health and Human Services July 2014 – Federal Register Recent Federal Regulation Documents

This notice with comment period describes the general criteria we intend to use to evaluate the effectiveness and efficiency of Beneficiary and Family Centered Care (BFCC) Quality Improvement Organizations (QIOs) that will enter into contracts with CMS under the 11th Statement of Work (SOW) in May 2014 titled, ``Beneficiary and Family Centered Care (BFCC) Quality Improvement Organization (QIO) Contract'' (HHSM-500-2014-RFP-BFCC-QIO). This contract allows for a transition period from the incumbent QIOs to the successor QIOs. The activities for the BFCC-QIO SOW begin August 1, 2014. The evaluation of a BFCC-QIO's performance related to the SOW will be based on evaluation criteria specified for the tasks set forth in Attachment J-10 of the BFCC-QIOs' SOW contract.

A Plan developed by the State Council on Developmental Disabilities is required by federal statute. Each State Council on Developmental Disabilities must develop the plan, provide for public comments in the State, provide for approval by the State's Governor, and finally submit the plan on a five-year basis. On an annual basis, the Council must review the plan and make any amendments. The State Plan will be used (1) by any amendments. The State Plan will be used (2) by the Council as a planning document; (3) by the citizenry of the State as a mechanism for commenting on the plans of the Council; (4) by the Department as a stewardship tool, for ensuring compliance with the Developmental Disabilities Assistance and Bill of Rights Act of 2000, as one basis for providing technical assistance (e.g., during site visits), and as a support for management decision making.

The Presidential Commission for the Study of Bioethical Issues (the Commission) will conduct its eighteenth meeting on August 20, 2014. At this meeting, the Commission will discuss the BRAIN Initiative and ongoing work in neuroscience.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Potential Tobacco Product Violations Reporting Form'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Annual Reporting for Custom Device Exemption'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is issuing a final order to reclassify implanted blood access devices, a preamendments class III device, into class II (special controls) based on new information and subject to premarket notification and to further clarify the identification.

The Department of Health and Human Services (HHS) Assistant Secretary for Preparedness and Response (ASPR) Office of Policy and Planning (OPP), intends to provide a Single Source Cooperative Agreement Award to the Pasteur Foundation for project activities carried out by the Pasteur Institute to support global health security enhancements and International Health Regulations (IHR) (2005) implementation in select Sub-Saharan African and Southeast Asian countries. Specifically, ASPR, in close coordination with the HHS Centers for Disease Control and Prevention (CDC) and other U.S. Government (USG) stakeholders, will collaborate with the Pasteur Institute and select affiliate institutes within the Pasteur Institute International Network (IPIN) in Cameroon, Central African Republic, Ivory Coast, Madagascar, Senegal, and Cambodia to sustain and strengthen preparedness, detection, and communication capacities for pandemic influenza and other emerging and re-emerging infectious diseases in support of IHR (2005). Recognizing that the health security of the American people is intrinsically linked to the world's health security, and that international cooperation is critical to enhance global health security, this program is aligned with Article 44 of the IHR (2005), which directs State Parties to collaborate to detect, assess, and respond to events while developing, strengthening, and maintaining core public health surveillance and response capacities. The proposed cooperative agreement is also aligned with the Global Health Security Agenda that calls for action to accelerate progress toward a world safe and secure from infectious disease threats, and to promote global health security as an international security priority by preventing and reducing the likelihood of infectious diseases outbreaks, detecting threats early, and rapidly and effective responding to disease outbreaks that require multi-sectorial, international coordination and communication.\1\

The Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) intends to provide a Single Source Cooperative Agreement Award to the U.S.-Mexico Foundation for Science (Fundaci[oacute]n M[eacute]xico-Estados Unidos para la Ciencia [FUMEC]), who will be the awardee for project activities carried out by Mexico's Ministry of Health (MOH). This Cooperative Agreement will contribute to enhancing global health security and advancing the implementation and maintenance of International Health Regulations (IHR) (2005) core capacities in Mexico. Specifically, ASPR, in close coordination with the HHS Centers for Disease Control and Prevention (CDC) and other U.S. Government (USG) stakeholders, will collaborate with FUMEC and the Mexican MOH to sustain and strengthen preparedness, detection, and communication capacities for pandemic influenza and other emerging and re-emerging infectious diseases in Mexico, focusing on IHR National Focal Point and Points of Entry capacities. Recognizing that the health security of the American people is intrinsically linked to the world's health security and that international cooperation is critical to enhance global health security, this program is aligned with Article 44 of the IHR (2005), which directs state parties to collaborate to detect, assess, and respond to events, while developing, strengthening, and maintaining core public health surveillance and response capacities. Additionally, this program intends to support the collaboration with the Mexican MOH under the North American Plan for Animal and Pandemic Influenza (NAPAPI). Period Of Performance: September 30, 2014 to September 29, 2017.

HHS is announcing the availability of an interpretive rule providing HHS's interpretation of section 340B(e) of the Public Health Service Act (PHSA), entitled ``Implementation of the Exclusion of Orphan Drugs for Certain Covered Entities Under the 340B Program.'' The interpretive rule states that section 340B(e) of the PHSA excludes drugs with an orphan designation only when those drugs are transferred, prescribed, sold, or otherwise used for the rare condition or disease for which the drug was designated under section 526 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection of information regarding pH of smokeless tobacco products.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Generic FDA Rapid Response Surveys'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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 in the regulations for in vivo radiopharmaceuticals used for diagnosis and monitoring.

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 Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review of Behavioral Programs for Diabetes Mellitus, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information will improve the quality of this review. AHRQ is conducting this systematic review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173, and Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a).