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

The ``Million Hearts Challenge'' is a multidisciplinary call to innovators and developers to create an application that activates and empowers patients to take charge of their cardiovascular disease. Winning entries have the potential to help patients combat the nation's leading cause of death through medication adherence, a healthier diet, and a more active lifestyle while promoting the goals of the Million Hearts campaign. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. No. 111-358).

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting is open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meeting and/or participate in the public comment session should e-mail acmh@osophs.dhhs.gov.

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 Ivy Laboratories, Division of Ivy Animal Health, Inc. The supplemental ANADA provides for use of increased dose levels of melengestrol acetate and monensin in two-way, combination drug Type C medicated feeds for heifers fed in confinement for slaughter.

This document extends the comment period for two proposed rules published in the Federal Register on July 15, 2011. One proposed rule would implement the new Affordable Insurance Exchanges (``Exchanges''), consistent with Title I of the Patient Protection and Affordable Care Act of 2010 as amended by the Health Care and Education Reconciliation Act of 2010, referred to collectively as the Affordable Care Act. The other proposed rule would implement standards for States related to reinsurance and risk adjustment, and for health insurance issuers related to reinsurance, risk corridors, and risk adjustment consistent with Title I of the Affordable Care Act. The comment period for both proposed rules, which would have ended on September 28, 2011, is extended to October 31, 2011.

The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Vaccines and Related Biological Products Advisory Committee for the Center for Biologics Evaluation and Research (CBER) notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative to serve the Vaccines and Related Biological Products Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nomination will be accepted for current vacancies effective with this notice.

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 PRA).

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (215) entitled ``Target Animal Safety and Effectiveness Protocol Development and Submission.'' The purpose of this document is to provide sponsors guidance in preparation of study protocols for review by the Center for Veterinary Medicine, Office of New Animal Drug Evaluation. The recommendations included in this guidance are intended to reduce the time to protocol concurrence.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Provisional Patent Application No. 60/178,689, filed January 28, 2000 [HHS Ref. No. E-088-2000/0-US-01], now expired; PCT Patent Application No. PCT/US01/02686 [HHS Ref. No. E-088-2000/0-PCT-02] filed January 26, 2001, which published as WO/2001/54718 on August 2, 2001, now expired; U.S. Patent No. 7,431,931 [HHS Ref. No. E-088-2000/0-US-06]; Australian Patent No. 784344 [HHS Ref. No. E-088-2000/0-AU-04]; German Patent No. 60141681.308 [HHS Ref. No. E-088-2000/0-DE-08]; French Patent No. 1251869 [HHS Ref. No. E-088-2000/0-FR-09]; United Kingdom Patent No. 1251869 [HHS Ref. No. E-088-2000/0-GB-10]; and Canadian Patent Application No. 2398428 [HHS Ref. No. E-088-2000/0-CA-05], entitled ``Compositions and Method for Preventing Reactogenicity Associated with Administration of Immunogenic Live Rotavirus Compositions,'' and all continuing applications to International Medica Foundation, having a place of business in Rochester, Minnesota. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be ``worldwide'', and the field of use may be limited to ``rhesus-based rotavirus therapeutic and/or prophylactic vaccines.''

HPI-PSO: AHRQ has accepted a notification of voluntary relinquishment from the HPI-PSO, a component entity of Healthcare Performance Improvement, LLC, of its status as a Patient Safety Organization (PSO). The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41, 42 U.S.C. 299b-21b-26, provides for the formation of PSOs, which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR Part 3, authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, including when a PSO chooses to voluntarily relinquish its status as a PSO for any reason.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Applications for Premarket Review of New Tobacco Products.'' The draft guidance is intended to assist persons submitting applications for new tobacco products under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The draft guidance explains, among other things, for new tobacco product applications, who submits, when and how to submit, what information the FD&C Act requires applicants to submit, and what information FDA recommends that applicants submit.

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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on reprocessed single-use device labeling.

HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Sandia National Laboratories, Albuquerque, New Mexico, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On July 29, 2011, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.'' This guidance provides recommendations to applicants considering whether to request a waiver or reduction in user fees. This guidance is a revision of the draft guidance entitled ``Draft Interim Guidance Document for Waivers of and Reductions in User Fees,'' issued July 16, 1993.

This document corrects technical errors that appeared in the final rule published in the Federal Register on August 5, 2011 entitled ``Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2012; Changes in Size and Square Footage of Inpatient Rehabilitation Units and Inpatient Psychiatric Units,'' (hereinafter FY 2012 IRF PPS final rule (76 FR 47836)).

This document corrects technical errors and typographical errors in the final rule entitled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and FY 2012 Rates; Hospitals' FTE Resident Caps for Graduate Medical Education Payment; Corrections'' which appeared in the August 18, 2011 Federal Register.

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 certain regulations regarding environmental impact considerations, food additives, and generally recognized as safe (GRAS) substances to correct minor errors in the Code of Federal Regulations (CFR). This action is editorial in nature and is intended to provide accuracy and clarity to the Agency's regulations.

This proposed notice with comment period acknowledges the receipt of a deeming application from the Community Health Accreditation Program (CHAP) for continued recognition as a national accrediting organization for home health agencies (HHAs) that wish to participate in the Medicare or Medicaid programs. Section 1865(a)(3)(A) of the Social Security Act (the Act) requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.

This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2012. The calendar year 2012 AIC threshold amounts are $130 for ALJ hearings and $1,350 for judicial review.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Nursing (NINR), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This information collection was previously published in the Federal Register on June 16, 2011, page 35221 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. 5 CFR 1320.5 (General requirements) Reporting and Recordkeeping Requirements: Final Rule requires that the agency inform the potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number. This information is required to be stated in the 30-day Federal Register Notice. Proposed Collection: Title: NINR End-of-Life and Palliative Care Science Needs Assessment: Funding Source (Survey of Authors). Type of Information Collection Request: NEW. Need and Use of Information Collection: The NINR End-of-Life Science Palliative Care (EOL PC) Needs Assessment: Funding Source Questionnaire will obtain information on funding sources of EOL PC research published studies for which a funding source is not cited or the information is unclear. Target participants are authors of publicly-available EOL PC research studies published between 1997-2010 for whom a funding source is unknown or unclear. The questionnaire inquires about the funding source of the published study, type of funding received, year of funding, and duration of funded study. This is a 7-item questionnaire that takes approximately 5 minutes to complete. Data collected is part of a needs assessment to address the breadth and depth of EOL PC scientific issues for use in stimulating research capacity in the field. Frequency of Response: One time. Affected Public: Individual authors of publicly available EOL PC research publications who do not list a funding source or the source is unclear within their publication. Type of Respondents: EOL PC researchers. The annual reporting burden is as follows: Estimated Number of Respondents: 1840; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: .08; and Estimated Total Annual Burden Hours Requested: 147. There are no Capital Costs, Operating or Maintenance Costs to report. Request for comments: Written comments and/or suggestions from the public and affected agencies should address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Direct comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Dr. Amanda Greene, Office of Science Policy and Public Liaison, NINR, NIH, Democracy One, 6701 Democracy Blvd., Suite 710, Bethesda, MD 20892 or call non-toll-free number (301) 496-9601 or E-mail your request, including your address to: amanda.greene@nih.gov. Comments due date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Reproductive and Developmental ToxicitiesIntegrating Study Results to Assess Concerns.'' This guidance describes an approach to estimating possible human developmental or reproductive risks associated with drug or biological product exposure when a nonclinical finding of toxicity has been identified, but definitive human data are unavailable. The guidance is intended for drug developers planning to submit new drug applications (NDAs) and biologics licensing applications (BLAs), and who are assessing nonclinical toxicity information.

The Food and Drug Administration (FDA) has determined that the four drug products listed in this document were 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 these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Guidance for Industry: Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Pistachio-Derived Product as an Ingredient.'' The guidance clarifies for manufacturers who produce foods containing a pistachio- derived product as an ingredient that there is a risk that Salmonella species may be present in the incoming pistachio-derived product, and recommends measures to address that risk.

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance entitled ``Marketed Unapproved DrugsCompliance Policy Guide Sec. 440.100, Marketed New Drugs Without Approved NDAs or ANDAs'' (CPG 440.100). CPG 440.100 describes how FDA intends to exercise its enforcement discretion with regard to drug products marketed in the United States that do not have required FDA approval for marketing. CPG 440.100 has been revised to state that the enforcement priorities and potential exercise of enforcement discretion discussed in the CPG apply only to unapproved new drug products that are being commercially used or sold as of September 19, 2011. All unapproved new drugs introduced onto the market after that date are subject to immediate enforcement action at any time, without prior notice and without regard to the enforcement priorities set forth in CPG 440.100.

In compliance with the requirement 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, 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: Cancer Risk in U.S. Radiologic Technologists: Fourth Survey (NCI). Type of Information Collection Request: Reinstatement with change of a previously approved collection (OMB No. 0925-0405, expiration 02/28/2011). Need and Use of Information Collection: By conducting a fourth cohort follow-up survey in an ongoing cohort study of U.S. Radiologic Technologists (USRT), updated information will be collected on cancer and other medical outcomes, personal medical radiation procedures, and other risk factors from all participants, plus detailed employment data from subgroups of participants who performed or assisted with fluoroscopically-guided or radioisotope procedures. Researchers at the National Cancer Institute and The University of Minnesota have followed a nationwide cohort of 146,000 radiologic technologists since 1982, of whom 110,000 completed at least one of three prior questionnaire surveys and 23,454 are deceased. This cohort is unique because estimates of cumulative radiation dose to specific organs (e.g. breast) are available and the cohort is largely female, offering a rare opportunity to study effects of low-dose radiation exposure on breast and thyroid cancers, the two most sensitive organ sites for radiation carcinogenesis in women. The fourth survey will be administered by mail to approximately 93,000 living and located cohort members who completed at least one of the three previous surveys to collect information on new cancers and other disease outcomes, detailed work patterns and practices from technologists who worked with radioisotopes and interventional radiography procedures, and new or updated risk factors that may influence health risks. New occupational and medical radiation exposure information will be used to improve radiation dose estimates. The annual reporting burden is reported in Table 1. There are no capital costs, operating costs and/or maintenance costs to report.

With this notice, the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) requests public comment on the draft Public Health Service Guideline for Reducing Transmission of Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV) through Solid Organ Transplantation (Draft Guideline). The Draft Guideline can be found at https://www.regulations.gov under Docket No. CDC-2011-0011. Also found at the docket is a supporting document for reference, the Evidence Report. The Evidence Report includes primary evidence, studies, and data tables that were used by the Guideline authors in developing the recommendations in the Guideline. The Draft Guideline is for use by organ procurement organizations (OPOs); transplant centers, including physicians, nurses, administrators, and clinical coordinators; laboratory personnel responsible for testing and storing donor and recipient specimens; and persons responsible for developing, implementing, and evaluating infection prevention and control programs for OPOs and transplant centers. This Draft Guideline provides evidence-based recommendations for reducing unexpected transmission of HIV, HBV and HCV from deceased and living organ donors.

The Food and Drug Administration (FDA) is announcing a public meeting on the Animal Drug User Fee Act (ADUFA). FDA invites public comment on the ADUFA program and suggestions regarding the features FDA should propose for the next ADUFA program. Date and Time: The meeting will be held on November 7, 2011, from 9 a.m. to 12 noon. Location: The meeting will be held at the Food and Drug Administration, 7519 Standish Pl., 3d floor, Rm. A, Rockville, MD 20855. If you require special accommodations, please contact Patricia Arnwine (see Contact Person) at least 7 days before the meeting. Contact Person: Donal Parks, Food and Drug Administration, Center for Veterinary Medicine, 7519 Standish Pl., Rockville, MD 20855, 240- 276-8688, FAX: 240-276-9744, Donal.Parks@fda.hhs.gov, or Patricia Arnwine, Food and Drug Administration, Center for Veterinary Medicine, 7519 Standish Pl., Rockville, MD 20855, 240-276-9724, FAX: 240-276- 9744, Patricia.Arnwine@fda.hhs.gov. Comments: Regardless of attendance at the meeting, interested persons may submit either electronic or written comments regarding this document. Submit electronic comments to https://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA- 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document. Comments received by October 26, 2011, will be taken into consideration before the public meeting. Transcripts: Transcripts of the meeting will be available for review at the Division of Dockets Management and on the Internet at https://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActA DUFA/ ucm042891.htm approximately 30 days after the meeting.

The Food and Drug Administration (FDA) is announcing a public workshop entitled: ``Magnetic Resonance Imaging (MRI) Safety Public Workshop.'' The purpose of the public workshop is to discuss factors affecting the safe use of magnetic resonance imaging (MRI) and approaches to mitigate risks. The overall goal is to discuss strategies to minimize patient and staff risk in the MRI environment.

In accordance with the requirements of the Privacy Act of 1974, CMS is establishing a new system of records to support its shared savings programs, the first of which are the Medicare Shared Savings Program and Pioneer ACO Model (collectively referred to as the ACO program). The ACO program implements recent health care reform provisions of the Patient Protection and Affordable Care Act (PPACA), amending the Social Security Act (the Act). The system of records will contain personally identifiable information (PII) about certain individuals who participate in, or whose PII is used to determine eligibility of an Accountable Care Organization (ACO) to participate in, a shared savings program; i.e., Medicare fee-for-service (FFS) beneficiaries, sole proprietor health care ACO participants and ACO suppliers/providers, key leaders and managers of accountable care organizations (ACOs), and contact persons for ACOs. The program and the system of records are more thoroughly described in the Supplementary Information section and System of Records Notice (SORN), below.

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 approval of an original new animal drug application (NADA) filed by Merial, Ltd. The NADA provides for the veterinary prescription use of gamithromycin injectable solution for the management of bovine respiratory disease (BRD). FDA is also amending the regulations to add the established tolerances for residues of gamithromycin in edible tissues of cattle.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The ANADA provides for use of an ivermectin injectable solution for treatment and control of various internal and external parasites in cattle, swine, reindeer, and American bison.

The mission of the Substance Abuse and Mental Health Services Administration (SAMHSA) is to reduce the impact of substance abuse and mental illness on America's communities. Established in 1992, the Agency was directed by Congress to target effective substance abuse and mental health services to the people most in need, and to translate research in these areas more effectively and more rapidly into the general health care system. The National Registry of Evidence-based Programs and Practices (NREPP) is a key public resource SAMHSA has developed to help meet this directive. This notice announces NREPP's open submission period for Fiscal Year 2012, during which developers of interventions may submit an application for a potential review. The notice explains how submissions will be screened and selected, and provides guidance on the submission process. Potential applicants should be aware that this notice includes updated information relating to the eligibility of interventions and the review process that supersedes guidance provided in earlier Federal Register notices.

This final rule implements section 6411 of the Patient Protection and Affordable Care Act (the Affordable Care Act), and provides guidance to States related to Federal/State funding of State start-up, operation and maintenance costs of Medicaid Recovery Audit Contractors (Medicaid RACs) and the payment methodology for State payments to Medicaid RACs. This rule also directs States to assure that adequate appeal processes are in place for providers to dispute adverse determinations made by Medicaid RACs. Lastly, the rule directs States to coordinate with other contractors and entities auditing Medicaid providers and with State and Federal law enforcement agencies.

The ``Ensuring Safe Transitions from Hospital to Home'' challenge tasks developers with creating technology solutions that empower discharged patients to take charge of their health care during transitions of places of care. Innovative applications will help patients and their caregivers insure that they have all the information and materials, such as drug prescriptions, medical equipment, follow-up appointments, and emergency contacts, that they need to move safely to their next care setting. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111- 358).

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (214) entitled ``Draft Guidance for Industry, Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data'' (VICH GL35). This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft VICH guidance document is intended to provide recommended standards to construct a single electronic message to transmit data elements for submission of adverse event reports (AERs) to all member regions.

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: ``Health Literacy Item Set Supplemental to CAHPS Health Plan SurveyPretest of Proposed Questions and Methodology.'' 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 July 7th, 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.