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

This proposed rule would amend Head Start program regulations to codify statutory eligibility requirements for Head Start and Early Head Start program enrollment and strengthen procedures to determine, verify, certify, and maintain records regarding eligibility for Head Start and Early Head Start program enrollment. It also proposes to create new requirements for the person seeking services to certify in a signed and dated statement that the documents and information that the person provided concerning eligibility are accurate to the best of the person's knowledge, as well as new requirements for program staff who make the eligibility determination to certify in a signed and dated statement that the information on eligibility in the file is accurate to the best of the person's knowledge, and based on that information, the person has determined the pregnant woman or child to be eligible for services. In addition, it proposes to create a new requirement for agencies to establish policies and procedures describing the actions that will be taken against staff who violate eligibility determination requirements and requires agencies to provide training related to eligibility requirements and the legal consequences of committing fraud. The intent of this rule is to reduce substantially the risk that children or pregnant women who are ineligible for participation in Head Start or Early Head Start programs are enrolled in these programs.

This final rule will revise and expand current Medicare and Medicaid regulations regarding the imposition and collection of civil money penalties by CMS when nursing homes are not in compliance with Federal participation requirements in accordance with section 6111 of the Affordable Care Act of 2010.

In accordance with the requirements of the Privacy Act of 1974, as amended, this notice establishes a computer matching agreement between CMS and the Department of Defense (DoD). We have provided background information about the proposed matching program in the SUPPLEMENTARY INFORMATION section below. The Privacy Act requires that CMS provide an opportunity for interested persons to comment on the proposed matching program. We may defer implementation of this matching program if we receive comments that persuade us to defer implementation. See ``Effective Dates'' section below for comment period.

The Food and Drug Administration (FDA) has determined the regulatory review period for ISTODAX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

This proposed rule amends a provision in HHS regulations that prohibits State Medicaid Fraud Control Units (MFCU) from using Federal matching funds to identify fraud through screening and analyzing State Medicaid claims data, known as data mining. To support and modernize MFCU efforts to effectively pursue Medicaid provider fraud, we propose to permit Federal Financial Participation (FFP) in the costs of defined data mining activities under specified conditions. In addition, we propose that MFCUs annually report the costs and results of approved data mining activities to OIG.

Pursuant to 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), this will serve to notify the public that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to intellectual property broker ICAP Ocean Tomo to promote the utilization by the public of the inventions described in the following U.S. patents: 7,122,624 entitled ``PH2 Receptor Ligands'' (HHS Ref. No. E-123-1999/0), and 7,087,736 entitled ``Tyrosine DNA phosphodiesterases (TDP) and related polypeptides, nucleic acids, vectors, TDP producing host cells, antibodies and methods of use'' (HHS Ref. No. E-281-1999/0). The patent rights in this invention have been assigned to the United States of America. The prospective exclusive license territory may be worldwide and the field of use may be for the use of the Licensed Patent Rights in developing biopharmaceutical products.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) is publishing this notice requesting public comment on the draft A Public Health Action Plan to Combat Antimicrobial Resistance. HHS/CDC is publishing this notice on behalf of the HHS Interagency Task Force on Antimicrobial Resistance. The draft Action Plan and supporting documents can be found at https://www.regulations.gov.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry on Special Protocol Assessment'' 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 providing notice of exchange of letters between Dr. Murray M. Lumpkin, Deputy Commissioner, International and Special Programs, FDA and Mr. Martin Heraghty, Assistant Secretary General, Department of Agriculture, Fisheries and Food (DAFF), concerning certification requirements for caseins, caseinates, and mixtures thereof exported from Ireland to the United States. The mutual goals of FDA and DAFF in establishing certification requirements for caseins, caseinates, and mixtures thereof exported from Ireland to the United States are to assure that contaminated products will not be imported into the United States and to minimize the need for extensive FDA audit sampling of these products from Ireland. DAFF and FDA have a history of cooperation on this issue and it is, therefore, desirable that the two Agencies continue to cooperate to maintain and improve consumer protection.

Under the provisions of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: A Generic Submission for Formative Research, Pre-testing, Stakeholder Measures and Advocate Forms at NCI. Type of Information Collection Request: New. Need and Use of Information Collection: In order to carry out NCI's legislative mandate, the Office of Advocacy Relations (OAR) disseminates cancer- related information to a variety of stakeholders, seeks their input and feedback, and facilitates collaboration between the Institute and these external partners to advance NCI's authorized programs. It is beneficial for NCI, through the OAR, to pretest strategies, concepts, activities and materials while they are under development. Additionally, administrative forms may be part of this generic submission since they are a necessary part of collecting demographic information and areas of interest for advocates. Pre-testing, or formative evaluation, helps ensure that the products and services developed by NCI have the greatest capacity of being received, understood, and accepted by their target audiences. Since OAR is responsible for matching advocates to NCI programs and initiatives across the cancer continuum, it is necessary to measure the satisfaction of both internal and external stakeholders with this collaboration. This customer satisfaction research helps ensure the relevance, utility, and appropriateness of the many initiatives and products that OAR and NCI produce. The OAR will use a variety of qualitative (focus groups, interviews) and quantitative (paper, phone, in-person, and web surveys) methodologies to conduct this research, allowing NCI to: (1) Understand characteristics (attitudes, beliefs, and behaviors) of the intended target audience and use this information in the development of effective strategies, concepts, activities; (2) use a feedback loop to help refine, revise, and enhance OAR's efforts ensuring that they have the greatest relevance, utility, appropriateness, and impact for/to target audiences; and (3) expend limited program resource dollars wisely and effectively. Frequency of Response: On occasion. Affected Public: Individuals or households; Businesses or other for profit; Not-for-profit institutions and organizations; Federal Government; State, Local, or Tribal Government. Type of Respondents: Adult cancer research advocates; members of the public; health care professionals; organizational representatives. Table 1 outlines the estimated burden hours required for a three-year approval of this generic submission. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.