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

The Presidential Commission for the Study of Bioethical Issues will conduct its fifth meeting in May. At this meeting, the Commission will discuss the topic of Federal standards regarding human subjects protection in Federally funded scientific studies.

In accordance with the requirements of the Privacy Act of 1974, the Centers for Medicare and Medicaid Services (CMS), Center for Consumer Information and Insurance Oversight (CCIIO) is establishing a new system of records (SOR) titled the ``Health Insurance Assistance Database (HIAD),'' System No. 09-70-0586. This SOR is established under the authority of Sections 2719, 2723, and 2761 of the Public Health Service Act (PHS Act) (Public Law (Pub. L.) 97-35) and Sec. 1321(c) of the Patient Protection and Affordable Care Act (Affordable Care Act) (Pub. L. 111-148). Section 1321(c) of the Affordable Care Act authorizes HHS (1) to ensure that States with Exchanges are substantially enforcing the Federal standards to be set for the Exchanges and (2) to set up Exchanges in States that elect not to do so or are not substantially enforcing related provisions. Sections 2723 and 2761 of the PHS Act authorize HHS to enforce provisions that apply to non-Federal governmental plans and to enforce PHS Act provisions that apply to other health insurance coverage in States that HHS has determined are not substantially enforcing those provisions. The HIAD database will be maintained by the Office of Consumer Support Health Insurance Assistance Team (the Team) to assist the Office of Oversight with its compliance activities. HIAD is the primary tool through which the Team will track information for the purposes of oversight. The primary purpose of this system is to collect and maintain information on consumer inquiries and complaints regarding insurance issuers that will permit CCIIO to exercise its direct enforcement authority over non-Federal governmental health plans, investigate any inquiries or complaints from enrollees of those plans, to determine which States may not be substantially enforcing the Affordable Care Act and PHS Act provisions and to determine whether complaints that indicate possible noncompliance with Federal law are resolved by the plans. In addition, information maintained will enable CCIIO to develop aggregate reports that will inform CMS and HHS about compliance issues. Information in this system will also be disclosed to: (1) Support regulatory and programmatic activities such as investigations and reporting activities performed by an Agency contractor, consultants, CMS grantees, student volunteers, interns and other workers who do not have the status of Federal employees; (2) assist another Federal and/or State agency, agency of a State government, or an agency established by State law; (3) support litigation involving the Agency; (4) combat fraud, waste, and abuse in certain health benefits programs, and (5) assist in a response to a suspected or confirmed breach of the security or confidentiality of information. We have provided background information about this new system in the SUPPLEMENTARY INFORMATION section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See ``Effective Dates'' section for information about the comment period.

In accordance with the requirements of the Privacy Act of 1974, HRSA is deleting an existing system of records titled Record of Patient's Personal Valuables and Monies, HRSA SOR 09-15-0002, established at Vol. 59, No. 61 Federal Register pp 6854-6, December 28, 1994.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.'' This guidance document describes a means by which low level laser systems for aesthetic use may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify low level laser systems for aesthetic use into class II (special controls). This guidance document is being immediately implemented as the special control for low level laser systems for aesthetic use, but it remains subject to comment in accordance with the Agency's good guidance practices.

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.

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.