Department of Health and Human Services April 13, 2011 – Federal Register Recent Federal Regulation Documents

Pursuant to the Improving Head Start for School Readiness Act of 2007, Public Law 110-134, notice is hereby given of one-day Tribal Consultation Sessions to be held between the Department of Health and Human Services, Administration for Children and Families, Office of Head Start leadership and the leadership of Tribal Governments operating Head Start (including Early Head Start) programs. The purpose of these Consultation Sessions is to discuss ways to better meet the needs of American Indian and Alaska Native children and their families, taking into consideration funding allocations, distribution formulas, and other issues affecting the delivery of Head Start services in their geographic locations [42 U.S.C. 9835, Section 640(l)(4)].

This notice announces our intention to sponsor Federally Funded Research and Development Center (FFRDC) to facilitate the modernization of business processes and supporting systems and their operations. This is the first of three notices which must be published over a 90-day period in order to advise the public of the agency's intention to sponsor an FFRDC issued under the authority of 48 CFR 35.017.

U.S. Federal agency responses to ICCVAM test method recommendations on alternative testing methods and strategies proposed to further reduce and refine the use of animals for assessing the ocular hazard potential of chemicals and products are now available. ICCVAM recommended a pain management procedure that should always be used to avoid pain and distress when it is determined necessary to conduct the rabbit eye test for regulatory safety purposes. ICCVAM also recommended the Cytosensor Microphysiometer (CM) test method as a screening test (1) to identify some types of substances that will not cause sufficient injury to require eye hazard labeling and (2) to identify some types of substances that may cause permanent or severe eye injuries. ICCVAM previously forwarded recommendations to Federal agencies and made these recommendations available to the public (75 FR 57027). In accordance with the ICCVAM Authorization Act of 2000 (42 U.S.C. 285l-3), agencies have notified ICCVAM in writing of their findings and ICCVAM is making these responses available to the public. Federal agency responses are available on the NICEATM-ICCVAM Web site at https://iccvam.niehs.nih.gov/methods/ocutox/Transmit-2010.htm. The ICCVAM recommendations are provided in ICCVAM test method evaluation reports that are available on the NICEATM-ICCVAM Web site at https:// iccvam.niehs.nih.gov/methods/ocutox/OcuAnest-TMER.htm, https:// iccvam.niehs.nih.gov/methods/ocutox/MildMod-TMER.htm, https:// iccvam.niehs.nih.gov/methods/ocutox/AMCP-TMER.htm, and https:// iccvam.niehs.nih.gov/methods/ocutox/LVET.htm.

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 a study entitled ``Experimental Study on Consumer Responses to Labeling Statements on Food Packages.''

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 Food and Drug Administration (FDA) is amending the biologics regulations to permit the Director of the Center for Biologics Evaluation and Research (CBER) or the Director of the Center for Drug Evaluation and Research (CDER), as appropriate, to approve exceptions or alternatives to the regulation for constituent materials. A request for an exception or alternative will be considered for approval when the data submitted in support of such a request establish the safety, purity, and potency of the biological product for the conditions of use, including indication and patient population, for which the applicant is seeking approval. FDA is taking this action due to advances in developing and manufacturing safe, pure, and potent biological products licensed under the Public Health Service Act (the PHS Act) that, in some instances, render the existing constituent materials regulation too prescriptive and unnecessarily restrictive. This rule provides manufacturers of biological products with flexibility, as appropriate, to employ advances in science and technology as they become available, without diminishing public health protections.

The Food and Drug Administration (FDA) has determined that NOVANTRONE (mitoxantrone hydrochloride) Injection, equivalent to (EQ) 25 milligrams (mg) base/12.5 milliliters (mL) and EQ 30 mg base/15 mL, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Influenza: Developing Drugs for Treatment and/or Prophylaxis.'' This guidance is intended to assist sponsors in the clinical development of drugs and therapeutic biological products for the treatment and/or prophylaxis of illness caused by influenza viruses A and B, including both seasonal and pandemic varieties. This guidance finalizes the draft guidance issued February 20, 2009.

The Food and Drug Administration (FDA) is responding to objections and is denying requests that it received for a hearing on the final rule that amended the food additive regulations to provide for the safe use of ionizing radiation for the reduction of Salmonella in fresh shell eggs. After reviewing objections to the final rule and requests for a hearing, the Agency has concluded that the objections do not raise issues of material fact that justify a hearing or otherwise provide a basis for revoking or modifying the amendment to the regulation.

The Food and Drug Administration (FDA) is proposing to amend the regulations to expand the scope of clinical investigator disqualification. Under this proposal, when the Commissioner of Food and Drugs determines that an investigator is ineligible to receive certain test articles (drugs, devices, or new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA. This proposal is based in part upon recommendations from the Government Accountability Office, and is intended to help ensure adequate protection of research subjects and the quality and integrity of data submitted to FDA. FDA also is amending the list of regulatory provisions under which an informal regulatory hearing is available by changing the scope of certain provisions and adding regulatory provisions that were inadvertently omitted.

In accordance with Executive Order 13563, ``Improving Regulation and Regulatory Review,'' the Department of Health and Human Services (HHS) seeks comment from interested parties to assist in the development of its preliminary plan to review existing regulations. The purpose of the plan is to establish a process by which HHS can determine whether any such regulations should be modified, streamlined, expanded, or repealed so as to make HHS's regulatory program more effective or less burdensome in achieving its regulatory objectives.