Department of Health and Human Services April 11, 2014 – Federal Register Recent Federal Regulation Documents

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.

The Administration for Community Living (ACL) 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 information collection requirements relating to the Supplemental Form to the Financial Status Report for all ACL/AoA Title III Grantees.

The Administration for Community Living (ACL) is proud to announce the Paralysis Resource Center (PRC) is moving to ACL as a result of the 2014 budget recently signed by President Obama. ACL was formed in April 2012 to advance policy and implement programs that support the rights of older Americans and people with disabilities to live in their communities throughout their lifespan. The mission of the PRC aligns perfectly with ACL's mission and provides the Administration with important new programmatic opportunities to help persons with physical disabilities as well as older adults and people with developmental disabilities. The PRC provides a comprehensive, national source of information for people living with paralysis and their families to promote health, foster involvement in the community, and improve quality of life. Resources on spinal cord injury, paralysis and mobility-related disabilities, including information and referral by phone and email are available in English and Spanish. The PRC currently operates through a cooperative agreement between the Christopher & Dana Reeve Foundation and the U.S. Department of Health and Human Services (HHS) Centers for Disease Control and Prevention (CDC). ACL will be working with the CDC on transitioning the program to ACL. Program Name: Paralysis Resource Center. Award Amount: Up to $6,683,000. Project Period: 6/1/2014 to 5/31/2015. Award Type: Cooperative Agreement.

The Food and Drug Administration (FDA) has determined that ZOVIRAX (acyclovir sodium) Injection, equivalent to (EQ) 250 milligrams (mg) base/vial, 500 mg base/vial, and 1gram (g) base/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for ZOVIRAX (acyclovir sodium) Injection, EQ 250 mg base/vial, 500 mg base/vial, and 1 g base/vial, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the expanded safe use of spirulina extract as a color additive in food. This action is in response to a petition filed by GNT USA, Inc.

The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces a ``Collaborative Workshop on Aquatic Models and 21st Century Toxicology.'' The workshop proposes to explore and discuss how small aquarium fish species may be used as model organisms to screen and prioritize compounds for further in vivo testing and assess mechanisms of chemical toxicity. Discussions will focus on the application of these models to the field of environmental health while leveraging the techniques and knowledge of broad-based, interdisciplinary research.

On January 27, 2014, HRSA published Policy Information Notice (PIN) 2014-01 to convey and clarify statutory and regulatory governance requirements for section 330-funded health centers and look-alikes. The PIN, ``Health Center Program Governance,'' and HRSA's ``Comments and Response on Draft PIN: Health Center Program Governance'' are available on the Internet at https://www.bphc.hrsa.gov/policiesregulations/ policies/pin201401.html, and constitutes final agency guidance.