Department of Health and Human Services 2010 – Federal Register Recent Federal Regulation Documents
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Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-July Through September 2010
This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from July through September 2010, relating to the Medicare and Medicaid programs. This notice provides information on national coverage determinations (NCDs) affecting specific medical and health care services under Medicare. Additionally, this notice identifies certain devices with investigational device exemption (IDE) numbers approved by the Food and Drug Administration (FDA) that potentially may be covered under Medicare. This notice also includes listings of all approval numbers from the Office of Management and Budget for collections of information in CMS regulations and a list of Medicare- approved carotid stent facilities. Included in this notice is a list of the American College of Cardiology's National Cardiovascular Data registry sites, active CMS coverage-related guidance documents, and special one-time notices regarding national coverage provisions. Also included in this notice is a list of National Oncologic Positron Emissions Tomography Registry sites, a list of Medicare-approved ventricular assist device (destination therapy) facilities, a list of Medicare-approved lung volume reduction surgery facilities, a list of Medicare-approved clinical trials for fluorodeoxyglucose positron emissions tomography for dementia, and a list of Medicare-approved bariatric surgery facilities. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, and to foster more open and transparent collaboration efforts, we are also including all Medicaid issuances and Medicaid substantive and interpretive regulations (proposed and final) published during this 3-month timeframe.
Medicare Program; Request for Nominations for Members for the Medicare Evidence Development & Coverage Advisory Committee
This notice announces the request for nominations for consideration for membership on the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). Among other things, the MEDCAC advises the Secretary of the Department of Health and Human Services (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS), as requested by the Secretary, whether medical items and services are ``reasonable and necessary'' and therefore eligible for coverage under Title XVIII of the Social Security Act. We are requesting nominations for both voting and nonvoting members to serve on the MEDCAC. Nominees are selected based upon their individual qualifications and not as representatives of professional associations or societies. We have a special interest in ensuring that the interests of both women and men, members of all racial and ethnic groups, and physically challenged individuals are adequately represented on the MEDCAC. Therefore, we encourage nominations of qualified candidates who can represent these interests. The MEDCAC reviews and evaluates medical literature, reviews technology assessments, and examines data and information on the effectiveness and appropriateness of medical items and services that are covered or eligible for coverage under Medicare.
Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary SupplementsSmall Entity Compliance Guide.'' The small entity compliance guide (SECG) is being issued for a final rule and an interim final rule published in the Federal Register of June 25, 2007, and is intended to set forth in plain language the requirements of that final rule and interim final rule and to help small businesses understand the regulations. In addition, the SECG includes several recommendations made by FDA in that final rule so that the guidance in those recommendations will be readily accessible to small businesses.
Determination of Regulatory Review Period for Purposes of Patent Extension; ANGIOMAX
The Food and Drug Administration (FDA) has determined the regulatory review period for ANGIOMAX 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.
Medicare Program; First Semi-Annual Meeting of the Advisory Panel on Ambulatory Payment Classification Groups-February 28, 2011 Through March 2, 2011
This notice announces the first semi-annual meeting of the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel) for 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) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) concerning the clinical integrity of the APC groups and their associated weights established under the Medicare hospital Outpatient Prospective Payment System (OPPS). We will consider the Panel's advice as we prepare the proposed rule to update the Medicare hospital Outpatient Prospective Payment System (OPPS) for CY 2012.
Public Comment on the Draft Tribal Consultation Policy
On November 5, 2009, President Obama signed the ``Memorandum for the Heads of Executive Departments and Agencies on Tribal Consultation.'' The President stated that his Administration is committed to regular and meaningful consultation and collaboration with tribal officials in policy decisions that have tribal implications, including, as an initial step, through complete and consistent implementation of Executive Order 13175. The United States has a unique legal and political relationship with Indian tribal governments, established through and confirmed by the Constitution of the United States, treaties, statutes, executive orders, and judicial decisions. In recognition of that special relationship, pursuant to Executive Order 13175 of November 6, 2000, executive departments and agencies are charged with engaging in regular and meaningful consultation and collaboration with tribal officials in the development of Federal policies that have tribal implications, and are responsible for strengthening the government-to-government relationship between the United States and Indian Tribes. The Department of Health and Human Services (HHS) has taken its responsibility to comply with Executive Order 13175 very seriously over the past decade, including the initial implementation of a Department- wide policy on tribal consultation and coordination in 1997, and through multiple evaluations and revisions of that policy, most recently in 2008. Many HHS agencies have already developed their own agency-specific consultation policies that complement the Department- wide efforts. Since 2005, the Administration for Children and Families (ACF) has been working under the guidance of the HHS policy issued in 2005, and updated in 2008. Due to the various programs administered by ACF and the many requests from Tribes for consultation for specific programs, as well as specific program mandates for tribal consultation, ACF has decided to create an ACF Tribal Consultation Policy to help ACF program and regional offices better engage Federally recognized Indian Tribes in the development or revision of policies, regulations, and proposed legislation that impact American Indians. ACF firmly believes that to create a good policy, ACF needs input from Tribes to ensure that ACF is meeting tribal needs and to establish a partnership that can carry into the future. ACF solicited membership for an ACF Tribal/Federal Workgroup to develop the initial draft policy. The Workgroup met August 23 and 24, 2010, in Washington, DC, and again in Minneapolis, Minnesota, on September 16 and 17, 2010. The draft was reviewed by tribal leaders attending the ACF Tribal Consultation Session held in Washington, DC on September 29, 2010, and the Workgroup met again to address the comments heard at the Tribal Consultation Session. ACF will convene the Tribal/Federal Workgroup again to review and address the comments received from this publication.
Draft Guidance for Industry on Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination.'' This guidance is intended to assist sponsors in the codevelopment of two or more novel (not previously marketed) drugs to be used in combination to treat a disease or condition. This guidance provides recommendations and advice on how to address certain scientific and regulatory issues that will arise during codevelopment. The guidance is not intended to apply to development of fixed-dose combinations of already marketed drugs or to development of a single new investigational drug to be used in combination with an approved drug or drugs. The guidance is also not intended to apply to vaccines, gene or cellular therapies, blood products, or medical devices.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Institutional Review Boards
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study of Patient Information Prototypes
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Public Health Notification Readership Survey (Formerly Known as the Safety Alert/Public Health Advisory Readership Survey)
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary Cosmetic Registration Program
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 the collection of information associated with the Agency's Voluntary Cosmetic Registration Program (VCRP).
Statement of Organization, Functions and Delegations of Authority
The Food and Drug Administration (FDA) has reorganized its Center for Tobacco Products (CTP) by establishing two new offices: Office of Health Communication and Education and the Office of Compliance and Enforcement. In addition, CTP has made improvements to the current offices' functional statements. This organizational change is intended to fill the gaps in the current CTP structure and clarify major responsibilities designed for long-term success in administering the Family Smoking Prevention and Tobacco Control Act.
Uniform Compliance Date for Food Labeling Regulations
The Food and Drug Administration (FDA) is establishing January 1, 2014, as the uniform compliance date for food labeling regulations that are issued between January 1, 2011, and December 31, 2012. FDA periodically announces uniform compliance dates for new food labeling requirements to minimize the economic impact of label changes. On December 8, 2008, FDA established January 2, 2012, as the uniform compliance date for food labeling regulations issued between January 1, 2009, and December 31, 2010 (January 1, 2012 fell on a Sunday; therefore the uniform compliance date was January 2, 2012).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Food and Drug Administration Rapid Response Surveys
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act
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 (PRA).
Medicare Program; Re-Chartering of the Advisory Panel on Ambulatory Payment Classification (APC) Groups
This notice announces the re-chartering of the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel). The Secretary of the Department of Health and Human Services (the Secretary) re-chartered the Panel on November 21, 2010, for 2 years with the new Charter effective through November 21, 2012.
Medicare Program; Town Hall Meeting on Physician Quality Reporting System
This notice announces a Town Hall Meeting to discuss the Physician Quality Reporting System (previously known as the Physician Quality Reporting Initiative (PQRI)). The purpose of the Town Hall Meeting is to solicit input from participating stakeholders on the individual quality measures and measures groups being considered for possible inclusion in the proposed set of quality measures for use in the 2012 Physician Quality Reporting System and key components of the design of the Physician Quality Reporting System. Measure developers, eligible professionals, professionals associations, such as medical specialty societies, and other interested stakeholders are invited to participate, in person or by teleconference. The meeting is open to the public, but attendance is limited to space and teleconference lines available.
Proposed Collection; Comment Request; GuLF Worker Study: Gulf Long-Term Follow-Up Study for Oil Spill Clean-Up Workers and Volunteers
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Environmental Health Sciences (NIEHS), 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 proposed information collection was previously published in the Federal Register on 7 October 2010 on pages 62132-3 and allowed 60-days for public comment. One public comment was received and addressed regarding the appropriateness and sources for funding the survey. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. 5 CFR 1320.5: Reporting and Recordkeeping Requirements: Final Rule: Respondents to this collection of information are not required to respond unless the data collection instruments display a currently valid OMB control number.
Submission for OMB Review; Comment Request; Recruitment and Screening for the Insight Into Determination of Exceptional Aging and Longevity (IDEAL) Study
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute on Aging (NIA), 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 proposed information collection was previously published in the Federal Register on September 17, 2010, page 57038 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. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995 unless it displays a currently valid OMB control number.
Government-Owned Inventions; Availability for Licensing
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.
Government-Owned Inventions; Availability for Licensing
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.
Determination of Regulatory Review Period for Purposes of Patent Extension; SAMSCA
The Food and Drug Administration (FDA) has determined the regulatory review period for SAMSCA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; VIBATIV
The Food and Drug Administration (FDA) has determined the regulatory review period for VIBATIV and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; FREESTYLE NAVIGATOR
The Food and Drug Administration (FDA) has determined the regulatory review period for FREESTYLE NAVIGATOR 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 medical device.
Government-Owned Inventions; Availability for Licensing
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Color Additive Certification Requests and Recordkeeping
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 the information collection provisions of FDA's regulations governing batch certification of color additives manufactured for use in foods, drugs, cosmetics or medical devices in the United States.
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Sagar S. Mungekar, PhD, New York University School of Medicine: Based on the Respondent's written admission and set forth below, the New York University School of Medicine (NYUSOM) and the Office of Research Integrity (ORI) found that Sagar S. Mungekar, PhD, former MD/ PhD student in the Sackler Institute of Graduate Biomedical Sciences at NYUSOM, engaged in research misconduct in research supported by National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), grants R01 GM35769, R01 GM55624, and T32 GM07308, and National Institute of Allergy and Infectious Diseases (NIAID), NIH, grant T32 AI007180. Dr. Mungekar admitted that in his PhD thesis he ``increased statistical significance of the calculated means and standards of deviation [sic] of the UV spectrophometic [sic] data presented by discarding certain experimental data and thus presented data that was falsified. In addition, as the repression ratios calculated and conclusions reached based on these data that included falsified data, those values and conclusions are fabricated. Approximately, 60-75 of the [Respondent's] PhD research data was changed or falsified.'' Dr. Mungekar also admitted ``while doing these experiments, I did not sequence all of the constructs that I constructed, thus, I could not be certain of the exact identity of the plasmids in question.'' ORI found that Dr. Mungekar engaged in research misconduct (42 CFR 93.103) by fabricating and falsifying data. Specifically, ORI found that Dr. Mungekar falsified five tables and five figures (Tables 2-1, 2-2, 3-1, 4-1, 4-2 and Figures 2-3, 3-1, 3-2, 4-3, and 4-4) in his Ph.D. thesis entitled ``Autoregulation of Ribonuclease E,'' by discarding certain spectrophotometric data, to increase statistical significance, used to calculate repression ratios and RNA decay rates. Dr. Mungekar also claimed to have constructed 53 different reporter plasmids with RNase E mutants, when sequencing data did not exist to support this claim. Dr. Mungekar has entered into a Voluntary Settlement Agreement in which he has voluntarily agreed, for a period of three (3) years, beginning on November 22, 2010: (1) That any institution that submits an application for PHS support for a research project on which the Respondent's participation is proposed or that uses him in any capacity on PHS-supported research, or that submits a report of PHS-funded research in which he is involved, must concurrently submit a plan for supervision of his duties to ORI for approval; the supervisory plan must be designed to ensure the scientific integrity of his research contribution; Respondent agrees that he will not participate in any PHS-supported research until such a supervision plan is submitted to ORI; (2) that any institution employing him submits, in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHS-funded research in which he is involved, a certification to ORI that the data provided by the Respondent are based on actual experiments or are otherwise legitimately derived and that the data, procedures, and methodology are accurately reported in the application or report; and (3) to exclude himself voluntarily from serving in any advisory capacity to the U.S. Public Health Service (PHS), including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant.
Medical Device User Fee Program; Meetings on Reauthorization; Request for Notification of Patient and Consumer Advocacy Group Intention to Participate
The Food and Drug Administration (FDA) is issuing this notice to request that patient and consumer advocacy groups notify FDA of their intent to participate in periodic consultation meetings on reauthorization of the Medical Device User Fee Amendments of 2007 (MDUFA) (the Food and Drug Administration Amendments Act of 2007). The statutory authority for MDUFA expires September 30, 2012. At that time, new legislation will be required for FDA to continue collecting user fees for the medical device program. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next MDUFA program. The FD&C Act also requires that FDA hold continued discussions with representatives of patient and consumer advocacy groups at least monthly during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these discussions by establishing consistent patient and consumer advocacy group representation.
Implementation of Section 2695 (42 U.S.C. 300ff-131) of Public Law 111-87: Infectious Diseases and Circumstances Relevant to Notification Requirements
The Ryan White HIV/AIDS Treatment Extension Act of 2009 (Pub. L. 111-87) addresses notification procedures for designated officers, medical facilities, and State and community public health officers regarding exposure of emergency response employees (EREs) to potentially life-threatening infectious diseases. The Secretary of Health and Human Services (Secretary) has delegated authority to the Director of the Centers for Disease Control and Prevention (CDC) to issue a list of potentially life-threatening infectious diseases, including emerging infectious diseases, to which EREs may be exposed in responding to emergencies (including a specification of those infectious diseases that are routinely transmitted through airborne or aerosolized means); guidelines describing circumstances in which employees may be exposed to these diseases; and guidelines describing the manner in which medical facilities should make determinations about exposures. CDC is seeking comment on the list of diseases and guidelines contained in this notice.
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