Department of Health and Human Services February 2007 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 269
Medicare Program; Listening Session on the Draft Plan for Medicare Hospital Value-Based Purchasing-April 12, 2007
This notice announces the second Listening Session being conducted as part of the development of a plan for Medicare hospital value-based purchasing, as authorized by section 5001(b) of the Deficit Reduction Act of 2005 (Pub. L. 109-171) (DRA). The purpose of the second Listening Session is to solicit comments on the Draft Plan that has been developed. Hospitals, hospital associations, and all interested parties are invited to attend and make comments in person. The perspectives expressed during this session and in writing will assist us in making revisions to the Draft Plan to create the final Medicare Hospital Value-Based Purchasing Plan to be completed by June 2007. The Draft Plan will be posted no later than March 22, 2007 on the CMS Web site, Hospital Center, under Spotlights at https:// www.cms.hhs.gov/center/hospital.asp.
Medicare and Medicaid Programs; Announcement of an Application From a Hospital Requesting Waiver for Organ Procurement Service Area
This notice announces a hospital's request for a waiver from entering into an agreement with its designated organ procurement organization (OPO), in accordance with section 1138(a)(2) of the Social Security Act (the Act). This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.
Withdrawal of Approval of 128 Suitability Petitions
The Food and Drug Administration (FDA) is withdrawing approval of 128 suitability petitions. This action is being taken in accordance with the Pediatric Research Equity Act of 2003 (PREA). Prior to PREA's enactment, FDA had approved these suitability petitions to permit abbreviated new drug applications (ANDAs) to be submitted for drugs that had a different active ingredient, dosage form, or route of administration than their reference listed drugs (RLDs). However, these approval decisions are being withdrawn because ANDAs were never submitted and PREA requires that all applications submitted on or after April 1, 1999, for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration contain an assessment of the safety and effectiveness of the drug for the claimed indications in relevant pediatric subpopulations unless the requirement is waived or deferred. This action is being taken without prejudice. Any of the suitability petitions may be resubmitted for action by the agency in accordance with current law.
Determination of Regulatory Review Period for Purposes of Patent Extension; BARACLUDE
The Food and Drug Administration (FDA) has determined the regulatory review period for BARACLUDE 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 that claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; EXJADE
The Food and Drug Administration (FDA) has determined the regulatory review period for EXJADE 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 that claims that human drug product.
Medicare Program; Announcement of New Members to the Advisory Panel on Ambulatory Payment Classification (APC) Groups
This notice announces five new members selected to serve on the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel). The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary, DHHS, (the Secretary) and the Administrator, CMS, (the Administrator) concerning the clinical integrity of the APC groups and their associated weights. We will consider the Panel's advice as we prepare the annual updates of the hospital outpatient prospective payment system (OPPS).
Medicare Program; Notice of Supplemental Election Period for Provider Participation in the Calendar Year (CY) 2007 Competitive Acquisition Plan for Part B Drugs
This notice announces an additional physician election period for physicians who are not currently participating in the competitive acquisition program (CAP) for Medicare Part B drugs for calendar year (CY) 2007. The additional physician election period begins on May 1, 2007 and ends on June 15, 2007. Physicians who elect to join the CAP during this additional election period will enter into a physician election agreement effective August 1, 2007 through December 31, 2007.
Program; Public Meetings in Calendar Year 2007 for All New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding and Payment Determinations
This notice announces the dates, time, and location of the Healthcare Common Procedure Coding System (HCPCS) public meetings to be held in calendar year 2007 to discuss our preliminary coding and payment determinations for all new public requests for revisions to the HCPCS. These meetings provide a forum for interested parties to make oral presentations or to submit written comments in response to preliminary coding and payment determinations. Discussion will be directed toward responses to our specific preliminary recommendations and will include all items on the public meeting agenda.
Medicare, Medicaid, and CLIA Programs; Approval of the Joint Commission (Formerly the Joint Commission on Accreditation of Healthcare Organizations) as a CLIA Accreditation Organization
This notice announces CMS' grant of deeming authority to the Joint Commission (formerly the Joint Commission on Accreditation of Healthcare Organizations) under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. We have determined that the requirements of the Joint Commission accreditation process are equal to or more stringent than the CLIA condition level requirements, and that the Joint Commission has met the requirements of subpart E of 42 CFR part 493. Consequently, laboratories that are voluntarily accredited by the Joint Commission and continue to meet the Joint Commission requirements will be deemed to meet the CLIA condition level requirements for laboratories and therefore are not subject to routine inspection by State survey agencies to determine their compliance with Federal requirements. They are, however, subject to Federal validation and complaint investigation surveys conducted by us or our designee.
Medicare, Medicaid, and CLIA Programs; Approval of COLA (Formerly the Commission on Office Laboratory Accreditation) as a CLIA Accreditation Organization
In this notice, we grant COLA (formerly the Commission on Office Laboratory Accreditation) deeming authority as an accrediting organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. We have determined that the requirements of the COLA accreditation process are equal to or more stringent than the CLIA condition level requirements, and that COLA has met the requirements of subpart E of 42 CFR Part 493. Consequently, laboratories that are voluntarily accredited by COLA and continue to meet COLA requirements will be deemed to meet the CLIA condition-level requirements for laboratories and therefore are not subject to routine inspection by State survey agencies to determine their compliance with Federal requirements. They are, however, subject to Federal validation and complaint investigation surveys conducted by us or our designee.
Office of the National Coordinator for Health Information Technology; American Health Information Community Population Health and Clinical Care Connections Workgroup Meeting
This notice announces the 15th meeting of the American Health Information Community Population Care and Clinical Care Connections Workgroup [formerly BioSurveillance Workgroup] in accordance with the Federal Advisory Committee Act (Pub. L. no. 92-463, 5 U.S.C., App.)
Office of the National Coordinator for Health Information Technology; American Health Information Community Chronic Care Workgroup Meeting
This notice announces the 14th meeting of the American Health Information Community Chronic Care Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.)
Office of the National Coordinator for Health Information Technology; American Health Information Community Electronic Health Records Workgroup Meeting
This notice announces the 14th meeting of the American Health Information Community Electronic Health Records Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Consumer Empowerment Workgroup Meeting
This notice announces the 15th meeting of the American Health Information Community Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.)
Office of the National Coordinator for Health Information Technology; American Health Information Community Personalized Healthcare Workgroup Meeting
This notice announces the 3rd meeting of the American Health Information Community Personalized Healthcare Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 93-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Quality Workgroup Meeting
This notice announces the 6th meeting of the American Health Information Community Quality Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
Substances Approved for Use in the Preparation of Meat and Poultry Products; Announcement of Effective Date
The Food and Drug Administration (FDA) is announcing the effective date for the information collection requirements contained in a final rule published in the Federal Register of August 25, 2000 (65 FR 51758). The rule amended FDA's regulations on food additive and color additive petitions to permit an efficient joint review by both FDA and the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA), of petitions for approval to use a food ingredient or source of radiation in or on meat or poultry products. An information collection requirement cannot be instituted unless it is reviewed by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA), approved by OMB, and assigned an OMB control number. OMB's approval of the information collection requirements of the August 25, 2000, final rule was announced in the Federal Register of March 1, 2001 (66 FR 12938), and these requirements are currently approved under OMB control number 0910-0016. Accordingly, FDA is announcing that the information collection requirements of the August 25, 2000, final rule will go into effect on March 26, 2007.
Determination of Regulatory Review Period for Purposes of Patent Extension; LEVEMIR
The Food and Drug Administration (FDA) has determined the regulatory review period for LEVEMIR 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 that claims that human drug product.
Privacy Act of 1974; Report of a Modified or Altered System of Records
The Privacy Act of 1974 and section 1106 of the Social Security Act (the Act) explain when and how CMS may release the personal data of people with Medicare. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Public Law 108-173) added requirements for releasing and using personal data. The primary purpose of this system is to collect, maintain, and process information on all Medicare covered, and as many non-covered drug events as possible, for people with Medicare who have a Medicare Part D plan. The system will help CMS determine appropriate payment of covered drugs. It will also provide for processing, storing, and maintaining drug transaction data in a large-scale database, while putting data into data marts to support payment analysis. CMS would allow the release of information in this system to: (1) Support regulatory, analysis, oversight, reimbursement, and policy functions performed within the agency or by a contractor, consultant, or a CMS grantee; (2) help another Federal and/or state agency, agency of a state government, an agency established by state law, or its fiscal agent; (3) help Medicare Part D plans; (4) support an individual or organization for a research, an evaluation, or an epidemiological or other project related to protecting the public's health, the prevention of disease or disability, the restoration or maintenance of health, or for payment related purposes; (5) help Quality Improvement Organizations; (6) support lawsuits involving the agency; and (7) combat fraud, waste, and abuse in certain health benefits programs. To meet these additional requirements, CMS proposes to modify the existing system of records (SOR) titled ``Medicare Drug Data Processing System (DDPS),'' System No. 09-70-0553, established at 70 Federal Register (FR) 58436 (October 6, 2005). Under this modification we are clarifying the statutory authorities for which these data are collected and disclosed. The original SOR notice cited the statutory section governing CMS's payment of Part D plan sponsors (Social Security Act (the Act) Sec. 1860D-15) that limits the uses of the data collected to plan payment and oversight of plan payment. However, the broad authority of Sec. 1860D-12(b)(3)(D) authorizes CMS to collect, use and disclose these same claims data for broader purposes related to CMS's responsibilities for program administration and research. Furthermore the authority under Sec. 1106 of the Act allows the Secretary to release data pursuant to a regulation, which in this case would be 42 CFR 423.322 and 423.505. CMS has published a Notice of Proposed Rulemaking (NPRM) in order to clarify our statutory authority and explain how we propose to implement the broad authority of Sec. 1860D- 12(b)(3)(D). This SOR is being revised to reflect our intended use of this broader statutory authority. CMS proposes to make the following modifications to the DDPS system: Revise routine use number 1 to include CMS grantees that perform a task for the agency. Add a new routine use number 2 to allow the release of information to other Federal and state agencies for accurate payment of Medicare benefits; to administer a Federal health benefits program, or to fulfill a requirement or allowance of a Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; and help Federal/state Medicaid programs that may need information from this system. Broaden the scope of routine use number 4 to allow the release of data to an individual or organization for a research, evaluation, or epidemiological or other project related to protecting the public's health, the prevention of disease or disability, the restoration or maintenance of health, or payment-related projects. Delete routine use number 5 which authorizes disclosure to support constituent requests made to a congressional representative. Broaden the scope of routine use number 7 and 8, to include combating ``waste,'' fraud, and abuse that results in unnecessary cost to all Federally-funded health benefit programs. Revise language regarding routine uses disclosures to explain the purpose of the routine use and make clear CMS's intention to release personal information contained in this system. Reorder and prioritize the routine uses. Update any sections of the system affected by the reorganization or revision of routine uses because of MMA provisions. Update language in the administrative sections to be consistent with language used in other CMS SORs. Although the Privacy Act allows CMS to only ask for comments on the modified routine uses, CMS is asking for comments on all proposed changes discussed in this notice. See the EFFECTIVE DATES section below for the comment period.
Insect Repellent-Sunscreen Drug Products for Over-the-Counter Human Use; Request for Information and Comments
The Food and Drug Administration (FDA) is seeking information to formulate a regulatory position on insect repellent products that contain over-the-counter (OTC) sunscreen ingredients. FDA is considering amending its monograph for OTC sunscreen drug products (the regulation that establishes conditions under which these drug products are generally recognized as safe and effective and not misbranded) to add conditions for marketing insect repellent-sunscreen drug products. The insect repellent ingredients in these products are regulated by the Environmental Protection Agency (EPA). Elsewhere in this issue of the Federal Register is a companion document in which EPA is also requesting information and comments on these products. The decision on what regulations, if any, to propose will be based, in part, on information and comments submitted in response to this request for data and information.
Proposed Collection; Comment Request; Customer Satisfaction With Educational Programs and Products of the National Cancer Institute
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 (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.
Prospective Grant of Exclusive License: The Use of Adenovirus Vectors for the Development of Vaccines Against Human Immunodeficiency Virus and Other Infectious Agents
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of an exclusive patent license to practice the inventions embodied in Patent Cooperation Treaty Application No. PCT/US02/27592 filed August 29, 2002 and United States National Stage Application Serial No. 10/487,974 filed February 27, 2004, entitled ``New Adenovirus Type 7 Vectors'' [HHS Reference No. E-236-2001/0], and United States Patent Application Serial No. 11/282,319 filed November 17, 2005, entitled ``Improved Replication-Competent Adenovirus Vectors'' [HHS Reference No. E-203-2004/0], to PaxVax, Inc., which has offices in Menlo Park, CA. The patent rights in these inventions have been assigned and/or exclusively licensed to the Government of the United States of America. The prospective exclusive license territory may be the United States of America, and the field of use may be limited to the development of vaccines against human immunodeficiency virus, human papillomavirus, influenza, malaria, and tuberculosis.
Proposed Collection Comment Request; Monitoring and Evaluation of the NIDA Goes Back to School National Dissemination Campaign; Revision
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collection of information, the National Institute on Drug Abuse (NIDA), 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. We are publishing a revised version of the notice that we published in the Federal Register on January 30, 2006 (72 FR 4273-4274) to reflect a correction in the data presented in Table A. In the previous notice, we inadvertently calculated the burden totals on the basis of 400 subjects for a single year. We should have calculated the burden totals on the basis of 400 subjects per each of three study years. Today's notice corrects that error.
Control of Communicable Diseases; Restrictions on African Rodents, Prairie Dogs, and Certain Other Animals
The Food and Drug Administration (FDA) is reopening the comment period for the interim final rule on the capture, transport, sale, barter, exchange, distribution, and release of African rodents, prairie dogs, and certain other animals, which was published in the Federal Register of November 4, 2003 (68 FR 62353). FDA is taking this action because it is adding new information, primarily in the form of peer-reviewed scientific literature, to the administrative record. FDA is reopening the comment period for 30 days for the sole purpose of inviting public comments on the information being added to the administrative record.
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