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

The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of 13 new animal drug applications (NADAs). In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of these NADAs.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Understanding Development Methods from Other Industries to Improve the Design of Consumer Health IT.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on January 27th, 2011 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from October through December 2010, relating to the Medicare and Medicaid programs.

HRSA will be providing a one-year extension with funds in the amount authorized in fiscal year (FY) 2010 to support activities that focus on cross-cutting publicly-funded health program integration and health access issues identified by the State and Territory governors and their senior health policy advisors, including addressing the needs of uninsured, underinsured and special needs populations, oral health, border health and health information technology as well as HRSA's overall strategic goals.

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 animal drug regulations to reflect revised human food safety warnings or updated pathogen nomenclature on dosage form new animal drug product labeling that have not been codified. The regulations are also being amended to correct the wording of certain other conditions of use, to correct minor errors, and to revise some sections to reflect a current format. These actions are being taken to comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and to improve the accuracy and readability of the regulations.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Pennfield Oil Co. The supplemental ANADA provides for use of oxytetracycline hydrochloride soluble powder for control of American and European foulbrood in honey bees and for skeletal marking of finfish fry and fingerlings.

The Food and Drug Administration (FDA) is amending the animal drug regulations to remove sections pertaining to use of arsanilate sodium and sulfaethoxypyridazine in medicated feed because there are no currently approved new animal drug applications (NADAs) for such uses. Conforming amendments are also being made. This action is being taken to improve the accuracy of the regulations.

The Food and Drug Administration (FDA) is announcing the availability of updated special controls guidance documents for class II devices, which contain edits that reflect the Agency's effort to clarify questions and confusion regarding its position on the binding nature of special controls guidance documents. The revised language does not change the Agency's position or view, but rather is intended to clarify its position and remedy any possible confusion or misunderstanding.

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.

This notice announces a forthcoming meeting of a public advisory committee of the Administration for Children and Families (ACF). The meeting will be open to the public. Name of Committee: Advisory Committee for Head Start Research and Evaluation. General Function of Committee: The Advisory Committee for Head Start Research and Evaluation will provide feedback on the published final report for the Head Start Impact Study, offering interpretations of the findings, discussing implications for practice and policy, and providing recommendations on follow-up research, including additional analysis of the Head Start Impact Study data. The Committee will also be asked to provide recommendations to the Secretary regarding how to improve Head Start and other early childhood programs by enhancing the use of research-informed practices in early childhood. Finally, the Committee will be asked to provide recommendations on the overall Head Start research agenda, includingbut not limited tohow the Head Start Impact Study fits within this agenda. The Committee will provide advice regarding future research efforts to inform HHS about how to guide the development and implementation of best practices in Head Start and other early childhood programs around the country.

The U.S. Department of Health and Human Services (HHS) announces the next federal advisory committee meeting regarding the national health promotion and disease prevention objectives for 2020. This meeting will be open to the public and will be held online via WebEx software. The Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2020 (Committee) will address efforts to implement the nation's health promotion and disease prevention objectives and strategies to improve the health status and reduce health risks for Americans by the year 2020. The Committee will provide to the Secretary of Health and Human Services advice and consultation for implementing Healthy People 2020, the nation's health promotion and disease prevention goals and objectives, and provide recommendations for initiatives to occur during the implementation phase of the goals and objectives. HHS will use the recommendations to inform the implementation of Healthy People 2020.

The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of the Pediatric Anesthesia Safety Initiative (PASI). The goal of PASI is to bridge the scientific and clinical gaps in the field of pediatrics to ensure the safe use of anesthetic and sedative agents in children. FDA seeks under PASI to encourage and facilitate scientific collaboration among multiple stakeholders within a public-private partnership (PPP) framework and to support the conduct of non-clinical and clinical studies to answer unknown questions regarding the effects of anesthetics and sedatives in the pediatric population. The output from PASI will help to inform the work of FDA as part of its public health mission.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Connecting Primary Care Practices with Hard-to-Reach Adolescent Populations.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on January 13th, 2011 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to b-26, (Patient Safety Act) provides for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of healthcare delivery. The Patient Safety Act (at 42 U.S.C. 299b-23) authorizes the collection of this information in a standardized manner, as explained in the related Patient Safety and Quality Improvement Final Rule, 42 CFR part 3 (Patient Safety Rule), published in the Federal Register on November 21, 2008: 73 FR 70731-70814. AHRQ coordinates the development of a set of common definitions and reporting formats (Common Formats) that allow healthcare providers to voluntarily collect and submit standardized information regarding patient safety events. In order to support the Common Formats, AHRQ has provided technical specifications to promote standardization by ensuring that data collected by PSOs and other entities are clinically and electronically comparable. More information on the Common Formats, including the technical specifications, can be obtained through AHRQ's PSO Web site: https://www.PSO.AHRQ.GOV/. The purpose of this notice is to announce a meeting to discuss the technical specifications, including the Hospital Common Formats technical specifications and the Skilled Nursing Facility Common Formats. This meeting is designed as an interactive forum where PSOs and software developers can provide input on these technical specifications for the Common Formats. AHRQ especially requests input from those entities which have used AHRQ's technical specifications and implemented, or plan to implement, the formats electronically.

This notice solicits nominations of two new members to the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel). There will be two vacancies on the Panel as of September 30, 2011. The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary of the Department of Health and Human Services (DHHS), and the Administrator of the Centers for Medicare & Medicaid Services (CMS), concerning the clinical integrity of the APC groups and their associated weights. The Secretary rechartered the Panel in 2010 for a 2-year period effective through November 21, 2012.

The Administration for Children and Families (ACF), Office of the Deputy Assistant Secretary and Inter-Departmental Liaison for Early Childhood Development announces the award of a cooperative agreement with the Congressional Hunger Center (CHC) in Washington, DC, to work with ACF programs on hunger and obesity issues for young children. An award in the amount of $3,000 has been made to the CHC.

The Food and Drug Administration (FDA) published a document in the Federal Register of April 23, 2010 (75 FR 21162), that amended the animal drug regulations to reflect approval of an original new animal drug application (NADA). FDA is correcting a paragraph describing limitations to the approved conditions of use for detomidine hydrochloride oromucosal gel in horses. This correction is being made to improve the accuracy of the animal drug regulations.

The Food and Drug Administration (FDA) published a document in the Federal Register of June 17, 2010 (75 FR 34361) revising the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA). That document contained an incorrect table entry describing the maximum florfenicol concentration in Type B medicated swine feeds. This correction is being made to improve the accuracy of the animal drug regulations.

This notice announces the $505 calendar year (CY) 2011 application fee for institutional providers that are: Initially enrolling in the Medicare, program; revalidating their Medicare enrollment; or adding a new Medicare practice location. These institutional providers and suppliers are required to submit the 2011 fee amount with any enrollment applications submitted on or after March 25, 2011 and on or before December 31, 2011. Similarly, beginning March 25, 2011 prospective or re-enrolling Medicaid or CHIP providers must submit the applicable application fee unless: (1) The provider is an individual physician or nonphysician practitioner; or (2) the provider is enrolled in Title XVIII of the Act or another State's title XIX or XXI plan and has paid the application fee to a Medicare contractor or another State.

The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled ``Draft Guidance for Industry: Compliance With Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents.'' This revised draft guidance replaces the original draft guidance published in the Federal Register of June 9, 2010 (75 FR 32791). The original draft guidance was revised to remove potential ambiguities and to address several issues not included in the original draft guidance. This revised draft guidance is intended to help small entities comply with the final rule entitled ``Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents.''

The Food and Drug Administration (FDA) is responding to objections and is denying requests that it has received for a hearing on the final rule that amended the food additive regulations to provide for the use of a bacteriophage preparation as an antimicrobial agent against Listeria monocytogenes on ready-to-eat (RTE) meat and poultry products. After reviewing the objections to the final rule and the 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 the amendment to the regulation. FDA also is denying the request for a stay of the effective date of the final rule.

The Food and Drug Administration (FDA) is announcing the availability of the special controls guidance entitled ``Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System.'' This guidance document describes a means by which the ovarian adnexal mass assessment score test system 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 these device types into class II (special controls). This guidance document is immediately in effect as the special control for the ovarian adnexal mass assessment score test system, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).

The Food and Drug Administration (FDA) is classifying the ovarian adnexal mass assessment score test system into class II (special controls). The special control that will apply to these devices is the guidance document entitled ``Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System.'' The Agency is classifying these devices into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of these devices and there is sufficient information to establish special controls. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for these devices.

The Office of Assistant Secretary for Health (OASH) is seeking nominations of qualified individuals to be considered for appointment as members of the Advisory Committee on Blood Safety and Availability (ACBSA). ACBSA is a Federal advisory committee within the Department of Health and Human Services. Management support for the activities of this Committee is the responsibility of the OASH. The qualified individuals will be nominated to the Secretary of Health and Human Services for consideration of appointment as members of the ACBSA. Members of the Committee, including the Chair, are appointed by the Secretary. Members are invited to serve on the Committee for up to four-year terms.

The Food and Drug Administration (FDA) is denying requests for a hearing on the final rule that amended the food additive regulations to provide for the safe use of ionizing radiation for the control of Vibrio species and other foodborne pathogens in fresh or frozen molluscan shellfish. After reviewing objections to the final rule and requests for a hearing, FDA has concluded that the objections do not justify a hearing or otherwise provide a basis for revoking the regulation. FDA also is denying the request for a stay of the effective date of the amendment to the food additive regulations.

The Food and Drug Administration (FDA) is denying a food additive petition (FAP 0M4181) proposing that the food additive regulations be amended to provide for the safe use of a source of irradiation to treat shellfish and finfish.

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.

The Food and Drug Administration (FDA) is announcing that it intends to refer for review before an advisory committee Ethicon Endo- Surgery Inc.'s (EES's), petition for review of the Agency's denial of premarket approval for its SEDASYS computer-assisted personalized sedation system (SEDASYS system).

The Food and Drug Administration (FDA) has determined the regulatory review period for ATRYN 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 biological product.

The Department of Health and Human Services (HHS) is proposing to treat chronic lymphocytic leukemia (CLL) as a radiogenic cancer under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA). Under current guidelines HHS promulgated as regulations in 2002, all types of cancers except for CLL are treated as being potentially caused by radiation and hence as potentially compensable under EEOICPA. HHS proposes to reverse its decision to exclude CLL from such treatment.

HHS gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees from Mathieson Chemical Co., Pasadena, Texas, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Mathieson Chemical Co. Location: Pasadena, Texas. Job Titles and/or Job Duties: All employees. Period of Employment: 1951 through October 2009.

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.