Department of Health and Human Services July 2010 – Federal Register Recent Federal Regulation Documents

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.

To help the Nation achieve national health security and to implement the first quadrennial National Health Security Strategy (NHSS) of the United States of America (2009) and build upon the NHSS Interim Implementation Guide for the National Health Security Strategy of the United States of America (2009) the U.S. Government has drafted a NHSS Biennial Implementation Plan (BIP). This document is intended to describe the priority activities to occur during fiscal years 2011 and 2012 of implementation so that all sectors and segments of the Nation are working collectively and leveraging resources to achieve the same outcomes. The activities include responsible entities, timelines and measures. The target audience for the BIP is the Nation (individuals, families, communities including all sectors and governments, states and the Federal Government). It also outlines a framework for evaluation of impact of the NHSS.

This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, September 22, 2010. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services can be covered under the Medicare statute. This meeting will focus on the currently available evidence regarding the clinical benefits and harms of on-label and off-label use of bone morphogenetic proteins (BMPs). This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).

This notice informs interested parties (here in there after referred to as conveners) of an opportunity to apply to participate in the Medicare Imaging Demonstration (MID) that was authorized by section 135(b) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). The goal of the MID is to collect data regarding physician compliance with appropriateness criteria selected by the Secretary under the terms of the statute in order to determine the appropriateness of advanced diagnostic imaging services furnished to Medicare beneficiaries.

Section 4205 of the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act) established requirements for nutrition labeling of standard menu items for restaurants and similar retail food establishments with 20 or more locations doing business under the same name and offering for sale substantially the same menu items (hereinafter ``chain retail food establishments''), and for certain foods sold in vending machines operated by an operator that owns or operates 20 or more vending machines (hereinafter ``chain vending machine operators''). Under the Affordable Care Act, retail food establishments and vending machine operators not covered by section 4205 of the Affordable Care Act may elect to become subject to its requirements by registering biannually with FDA. Congress required that, within 120 days of enactment of the Affordable Care Act (March 23, 2010), FDA issue a Federal Register notice specifying the terms and conditions for implementation of voluntary registration, pending promulgation of regulations. FDA is issuing this notice to assist restaurants and similar retail food establishments and vending machine operators that are not subject to the menu labeling requirements of section 4205 of the Affordable Care Act, but choose to register to become subject to them, in voluntarily registering with FDA, pending promulgation of regulations.

The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services (DHHS), has decided, after completion of a Final NIH Transportation EIS and a thorough consideration of the public comments on the Draft NIH Transportation EIS, to implement the Proposed Action, which was identified as the Preferred Alternative in both the Draft EIS and the FEIS. This action involves the transport of laboratory personnel suspected of having potential occupational exposure to infectious agents under study at the NIBC located at Fort Detrick, Maryland, to the Special Clinical Studies Unit at the NIH Bethesda, Maryland Campus for observation and, if necessary, treatment.

Section 479 of the Social Security Act (the Act) requires that the Administration for Children and Families (ACF) develop and write regulations to implement a system for the collection by title IV-E agencies of data relating to adoption and foster care. The resultant Adoption and Foster Care Analysis and Reporting System (AFCARS) has been operating since 1994 and is administered by the Children's Bureau (CB) in ACF. AFCARS collects case level information on all children in foster care for whom the title IV-E agency has responsibility for placement and care and on children adopted under the auspices of the title IV-E agency. We issued a Notice of Proposed Rulemaking (NPRM) on January 11, 2008 (73 FR 2082) that proposed to amend the AFCARS regulations at 45 CFR 1355.40 and the appendices to part 1355 [https:// edocket.access.gpo.gov/2008/E7-24860.htm]. The proposal would modify the requirements for title IV-E agencies to collect and report data to ACF on children in out-of-home care and in subsidized adoption or guardianship arrangements with the title IV-E agency. Due to the enactment of the Fostering Connections to Success and Increasing Adoptions Act of 2008 (Pub. L. 110-351) and the substantial changes it introduced in title IV-E, we intend to issue a new AFCARS NPRM. To inform development of the new NPRM we request that interested parties comment on the questions below.

The Health Resources and Services Administration and Administration for Children and Families, HHS, solicit comments by August 17, 2010 on proposed criteria for evidence of effectiveness of home visiting program models for pregnant women, expectant fathers, and primary caregivers of children birth through kindergarten entry. Final criteria for evidence of effectiveness will be included in the program announcement inviting eligible entities to apply for funding under the Affordable Care Act Maternal, Infant, and Early Childhood Home Visiting Program.