Department of Health and Human Services 2008 – Federal Register Recent Federal Regulation Documents
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Privacy Act of 1974; Notice of Modified System of Records
In accordance with the requirements of the Privacy Act of 1974, CMS is proposing to make minor amendments to an existing system of records (SOR) titled, ``Performance Measurement and Reporting System (PMRS),'' System No. 09-70-0584, published at 72 FR 52133 (September 12, 2007). PMRS serves as a master system of records to assist in projects that provide transparency in health care on a broad scale enabling consumers to compare the quality and price of health care services so that they can make informed choices among individual physicians, practitioners, and other providers of services. We are making minor amendments to PMRS to include two additional legal authorities: The Medicare, Medicaid, and SCHIP Extension Act of 2007 (MMSEA) (Pub. L. 110-173) and the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110-275). Section 101(b) of the MMSEA amended section 1848(k)(2)(B) of the Social Security Act (the Act) (42 U.S.C. 1395w-4) and section 101(c) of division B of the Tax Relief and Health Care Act of 2006 to extend the Physician Quality Reporting Initiative (PQRI). MIPPA, effective July 15, 2008, extended the PQRI for 2010 and subsequent years and authorized a new incentive program for successful electronic prescribers under section 1848(m)(2) of the Act. In addition, the MIPPA requires the Secretary to post on the CMS Web site the names of eligible professionals or group practices who satisfactorily submit data on quality measures through PQRI and the names of those eligible professionals or group practices who are successful electronic prescribers. This requirement is codified at section 1848(m)(5)(G) of the Act. Accordingly, CMS is adding Sec. Sec. 131 and 132 of MIPPA, Sec. 101 of MMSEA, Sec. 1848(k) of the Act, and Sec. 1848(m) of the Act to the PMRS' legal authority section. In addition, we are clarifying in this notice that the term, ``performance measurement results'' used in the PMRS includes, but is not limited to, submission of data on measures, e-prescribing usage, frequency of reporting or performance, as well as rates or scores based on application of specific measures. We consider all of these types of information to be valid indicators of a physician's, practitioner's, or other provider's commitment to and delivery of high quality, high value health care. The primary purpose of this system is to support the collection, maintenance, and processing of information to promote the delivery of high quality, efficient, effective, and economical health care services, and promoting the quality and efficiency of services of the type for which payment may be made under title XVIII by allowing for the establishment and implementation of performance measures, the provision of feedback to physicians, and public reporting of performance information. Information in this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed for the Agency or by a contractor, consultant, or a CMS grantee; (2) assist another Federal and/or state agency, agency of a state government, or an agency established by state law; (3) promote more informed choices by Medicare beneficiaries among their Medicare group options by making physician performance measurement information available to Medicare beneficiaries through a Web site and other forms of data dissemination; (4) provide CVEs and data aggregators with information that will assist in generating single or multi-payer performance measurement results to promote transparency in health care to members of their community; (5) assist individual physicians, practitioners, providers of services, suppliers, laboratories, and other health care professionals who are participating in health care transparency projects; (6) assist individuals or organizations with projects that provide transparency in health care on a broad scale enabling consumers to compare the quality and price of health care services; or for research, evaluation, and epidemiological projects related to the prevention of disease or disability; restoration or maintenance of health or for payment purposes; (7) assist Quality Improvement Organizations; (8) support litigation involving the agency; and (9) and (10) combat fraud, waste, and abuse in certain health benefits programs. We have provided background information about this modified system in the Supplementary Information section below
Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2009; E-Prescribing Exemption for Computer Generated Facsimile Transmissions; Corrections
This document corrects several technical and typographical errors in the final rule with comment period that appeared in the November 19, 2008 Federal Register entitled ``Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2009; E-Prescribing Exemption for Computer-Generated Facsimile Transmissions; and Payment for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Final Rule'' (73 FR 69726).
Agency Information Collection Activities: Proposed Collection; Comment Request
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: ``The AHRQ Data Inventory.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on October 24th, 2008 and allowed 60 days for public comment. One comment was received. The purpose of this notice is to allow an additional 30 days for public comment.
Agency Information Collection Activities; Proposed Collection; Comment Request; General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions
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 reporting requirements contained in existing FDA regulations regarding the general administrative procedures for a person to petition the Commissioner of Food and Drugs (the Commissioner) to issue, amend, or revoke a rule; to file a petition for an administrative reconsideration or an administrative stay of action; and to request an advisory opinion from the Commissioner.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Broadcast Advertisements
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. Due to an administrative error, this document is being republished.
Notice of Hearing: Reconsideration of Disapproval of Washington State Plan Amendment (SPA) 08-002
This notice announces an administrative hearing to be held on February 5, 2009, at the CMS Seattle Regional Office, 2201 Sixth Avenue, MS/RX-43, Seattle, Washington 98121 to reconsider CMS' decision to disapprove Washington SPA 08-002. Closing Date: Requests to participate in the hearing as a party must be received by the presiding officer by January 14, 2009.
Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2009 Rates; Payments for Graduate Medical Education in Certain Emergency Situations; Changes to Disclosure of Physician Ownership in Hospitals and Physician Self-Referral Rules; Updates to the Long-Term Care Prospective Payment System; Updates to Certain IPPS-Excluded Hospitals; and Collection of Information Regarding Financial Relationships Between Hospitals; Correction
This document corrects errors that appeared in the correction notice published in the October 3, 2008 Federal Register entitled ``Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2009 Rates; Payments for Graduate Medical Education in Certain Emergency Situations; Changes to Disclosure of Physician Ownership in Hospitals and Physician Self- Referral Rules; Updates to the Long-Term Care Prospective Payment System; Updates to Certain IPPS-Excluded Hospitals; and Collection of Information Regarding Financial Relationships Between Hospitals; Correction.''
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.
Proposed Collection; Comment Request; Women's Health Initiative Observational Study
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 Heart, Lung, and Blood Institute (NHLBI), 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: The Women's Health Initiative (WHI) Observational Study. Type of Information Collection Request: Revision OMB 0925-0414. Need and Use of Information Collection: This study will be used by the NIH to evaluate risk factors for chronic disease among older women by developing and following a large cohort of postmenopausal women and relating subsequent disease development to baseline assessments of historical, physical, psychosocial, and physiologic characteristics. In addition, the observational study will complement the clinical trial (which has received clinical exemption) and provide additional information on the common causes of frailty, disability and death for postmenopausal women, namely, coronary heart disease, breast and colorectal cancer, and osteoporotic fractures. Continuation of follow-up for ascertainment of medical history update forms will provide essential data for outcomes assessment for this population of aging women. Frequency of Response: Annually. Affected Public: Individuals or households and health care providers. Type of Respondents: Individuals or households; health care providers. The annual reporting burden is as follows:
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-July Through September 2008
This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from July 2008 through September 2008, 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 Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this 3-month time frame.
Agency Information Collection Activities; Proposed Collection; Comment Request; Notice of Participation
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 reporting requirements for filing a notice of participation with FDA.
Agency Information Collection Activities; Proposed Collection; Comment Request; Financial Disclosure by Clinical Investigators
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 information requiring the sponsor of any drug, biologic, or device marketing application to certify to the absence of clinical investigators and/or disclose those financial interests as required, when covered clinical studies are submitted to FDA in support of product marketing.
Notice of Hearing: Reconsideration of Disapproval of Montana State Plan Amendment (SPA) 08-003
This notice announces an administrative hearing to be held on January 27, 2009, at the CMS Denver Regional Office, 1600 Broadway, Suite 700, Denver, Colorado 80202 to reconsider CMS' decision to disapprove Montana SPA 08-003. Closing Date: Requests to participate in the hearing as a party must be received by the presiding officer by January 13, 2009.
Ophthalmic and Topical Dosage Form New Animal Drugs; Triamcinolone Cream
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 Modern Veterinary Therapeutics, LLC. The ANADA provides for veterinary prescription use of triamcinolone cream on dogs for topical treatment of allergic dermatitis and summer eczema.
Office of Global Health Affairs; Regulation on the Organizational Integrity of Entities That Are Implementing Programs and Activities Under the Leadership Act
The Office of Global Health Affairs within the U.S. Department of Health and Human Services (``HHS'') is issuing this final rule to clarify that recipients of HHS funds to implement HIV/AIDS programs and activities under the United States Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003 (the ``Leadership Act''), Public Law 108-25 (May 27, 2003), that are required to have a policy opposing prostitution and sex trafficking, and must submit certification of this policy with the grant or contract application, may, consistent with this policy requirement, maintain an affiliation with organizations that do not have such a policy, provided such affiliations do not threaten the integrity of the government's programs and its message opposing prostitution and sex trafficking. The rule describes the separation that must exist between a recipient of HHS HIV/AIDS funds that has a policy opposing prostitution and sex trafficking, as required under section 301(f) of the Leadership Act, 22 U.S.C. 7631(f), and another organization that engages in activities that are not consistent with a policy opposing prostitution and sex trafficking.
Regulatory Site Visit Training Program
The Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research (CBER) is reannouncing the invitation for participation in its Regulatory Site Visit Training Program (RSVP). This training program is intended to give CBER regulatory review, compliance, and other relevant staff an opportunity to visit biologics facilities. These visits are intended to allow CBER staff to directly observe routine manufacturing practices and to give CBER staff a better understanding of the biologics industry, including its challenges and operations. The purpose of this notice is to invite biologics facilities to contact CBER for more information if they are interested in participating in this program.
Solicitation of Nominations for Membership on the National Vaccine Advisory Committee
The National Vaccine Program Office (NVPO), a program office within the Office of Public Health and Science, Department of Health and Human Services (HHS), is soliciting nominations of qualified candidates to be considered for appointment as members to the National Vaccine Advisory Committee (NVAC). The activities of this Committee are governed by the Federal Advisory Committee Act (FACA). Management support for the activities of this Committee is the responsibility of the NVPO. Consistent with the National Vaccine Plan, the Committee advises and makes recommendations to the Assistant Secretary for Health in his capacity as the Director of the National Vaccine Program, on matters related to the Program's responsibilities. Specifically, the Committee studies and recommends ways to encourage the availability of an adequate supply of safe and effective vaccination products in the United States; recommends research priorities and other measures to enhance the safety and efficacy of vaccines. The Committee also advises the Assistant Secretary for Health in the implementation of Sections 2102 and 2103 of the PHS Act; and identifies annually the most important areas of government and non-government cooperation that should be considered in implementing Sections 2102 and 2103 of the PHS Act.
Notice of Issuance of Final Policy Directive
The Administration for Native Americans (ANA) herein issues final interpretive rules, general statements of policy and rules of agency organization, procedure or practice relating to the Social and Economic Development Strategies (hereinafter referred to as SEDS), Social and Economic Development Strategies for Alaska (hereinafter referred to as SEDS-AK), Native Language Preservation and Maintenance Assessment (hereinafter referred to as Native Language Assessment), Native Language Preservation and Maintenance Planning (hereinafter referred to as Native Language Planning), Native Language Preservation and Maintenance Implementation (hereinafter referred to as Native Language Implementation), Native Language Preservation and Maintenance Immersion (hereinafter referred to as Native Language Immersion), Family PreservationImproving the Well-Being of Children Project Planning (hereinafter referred to as Family Preservation Planning), Family PreservationImproving the Well-Being of Children Project Implementation (hereinafter referred to as Family Preservation Implementation) and Environmental Regulatory Enhancement (hereinafter referred to as ERE).
Agency Information Collection Activities; Proposed Collection; Comment Request; PDUFA Pilot Project Proprietary Name Review
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 associated with the evaluation of proposed propriety names by pharmaceutical firms and the submission of the data generated from those evaluations to FDA for review under a pilot program. FDA plans to begin enrollment in the pilot program by the end of fiscal year (FY) 2009.
Guidance for Industry and Food and Drug Administration Staff; “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300”; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300.'' This guidance document describes a means by which male condoms made of natural rubber latex (latex condoms) may comply with the requirement of special controls for class II devices. FDA believes that the labeling recommendations contained in this guidance, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of latex condoms without spermicidal lubricant. In the Federal Register of November 10, 2008 (73 FR 66522), FDA published a final rule that amended the classification regulation for condoms from class II (performance standards) to class II (special controls) and designated this guidance document as the special control for male condoms made of natural rubber latex classified under that regulation.
SEQC-The Sequencing Quality Control Project
The Food and Drug Administration (FDA) is soliciting volunteers to participate in the SEQC (Sequencing Quality Control) project to objectively assess the technical performance of different next-generation sequencing technologies in DNA (deoxyribonucleic acid) and RNA (ribonucleic acid) analyses and to evaluate the advantages and limitations of various bioinformatics solutions in handling and analyzing the massive new data sets. The SEQC project is a natural extension of the MicroArray Quality Control (MAQC) project (https:// www.fda.gov/nctr/science/centers/toxicoinformatics/maqc/) and is being coordinated by the FDA. This project is open to the public. Vendors of next-generation sequencing technologies and institutions interested in the generation, management, analysis, and interpretation of the resulting sequence data are welcome to participate.
Declaration Under the Public Readiness and Emergency Preparedness Act
Declaration pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d) to provide targeted liability protections for pandemic influenza diagnostics, personal respiratory protection devices, and respiratory support devices based on a credible risk that an avian influenza virus spreads and evolves into a strain capable of causing a pandemic of human influenza.
Medicare Program; Request for Nominations to the Advisory Panel on Ambulatory Payment Classification Groups
This notice solicits nominations of five new members to the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel). There will be five vacancies on the Panel as of August 16, 2009. 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 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 2008 for a 2-year period effective through November 21, 2010.
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