National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Non-Animal Methods and Approach for Evaluating Eye Irritation Potential for Antimicrobial Cleaning Products (AMCPs): Request for Nominations for an Independent Expert Panel and Submission of Relevant Data
At the request of the U.S. Environmental Protection Agency (EPA), the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) is planning to assess the validation status of a proposed non-animal approach for evaluating the eye irritation potential of AMCPs that meets hazard classification and labeling requirements. On behalf of ICCVAM, NICEATM requests: 1. Nominations of expert scientists to serve as members of an independent peer review panel. 2. Submission of relevant data and information on AMCPs or related substances obtained from (1) human testing or experience including reports from accidental exposures, (2) rabbits using the standard eye test or the low volume eye test (LVET), and (3) in vitro test methods for assessing ocular irritation, such as the Bovine Corneal Opacity and Permeability (BCOP) test, the Cytosensor Microphysiometer (CM) test, and the EpiOcular test, and data supporting the accuracy and reproducibility of these methods.
Medicaid Program: Home and Community-Based State Plan Services
This proposed rule would amend the Medicaid regulations to define and describe home and community-based State plan services implementing new section 1915(i) of the Social Security Act as added by section 6086 of the Deficit Reduction Act of 2005.
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.
Notice of Hearing: Reconsideration of Disapproval of Montana State Plan Amendment (SPA) 07-004
This notice announces an administrative hearing to be held on May 20, 2008, at the CMS Denver Regional Office, 1600 Broadway, Suite 700, Vail Conference Room, Denver, Colorado 80202, to reconsider CMS' decision to disapprove Montana SPA 07-004. Closing Date: Requests to participate in the hearing as a party must be received by the presiding officer by April 18, 2008.
Division of Loan Repayment; Submission for OMB Review; Comment Request; National Institutes of Health Loan Repayment Programs
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Division of Loan Repayment, the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on December 26, 2007, and allowed 60 days for public comment. No responses to the notice 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.
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) allow the proposed information collection project, ``Reducing Healthcare Associated Infections (HAI): Improving patient safety through implementing multidisciplinary training.'' 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.
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: ``Assessment of the Emergency Severity Index (ESI).'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (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 January 22nd, 2008 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.
Medicare Program; Modification to the Weighting Methodology Used To Calculate the Low-Income Benchmark Amount
This final rule changes the weighting methodology used to calculate the low-income benchmark premium amount (benchmark) for 2009 and thereafter. Under this final rule, the benchmark weighting methodology is adjusted so that the relative weights of the Medicare Advantage Prescription Drug (MA-PD) plan premiums and Prescription Drug Plan (PDP) plan premiums in the low-income benchmark premium amount reflect the distribution of enrollment of beneficiaries eligible for the low-income subsidy in each plan.
Agency Information Collection Activities; Proposed Collection; Comment Request; Temporary Marketing Permit Applications
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 contained in existing FDA regulations governing temporary marketing permit applications.
Determination of Regulatory Review Period for Purposes of Patent Extension; ACRYSOF
The Food and Drug Administration (FDA) has determined the regulatory review period for ACRYSOF 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.
Food Protection Plan; Outreach Activities; Opportunity for Public Comment
The Food and Drug Administration (FDA) is announcing that it is establishing a public docket to receive information and comments related to its comprehensive Food Protection Plan (the Plan) released in November 2007. The new Plan presents a robust strategy to protect the nation's food supply from both unintentional contamination and deliberate attack. FDA is establishing this docket for the purpose of soliciting comments from its stakeholders on the Plan and the questions set forth in this notice.
Notice of Public Meeting and Availability for Public Comment
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following meeting and request for public comment on the proposed national survey of healthcare workers' safety and health and a proposed national survey of employer safety and health practices. Public Comment Period: April 2, 2008 through July 1, 2008. Public Meeting Time and Date: 8 a.m.-4:30 p.m. EDT, April 30, 2008. Place: Sheraton Cincinnati Airport Hotel, 2826 Terminal Drive, Hebron, Kentucky 41048, (859) 371-6166. Purpose of the Meeting: To obtain public comment on the content and conduct of a survey of healthcare workers' safety and health practices and a separate survey of healthcare establishment's safety and health practices. Special emphasis will be placed on discussion of the following: (1) Content of the survey questionnaires; (2) Appropriate methods of conducting the surveys. Status: The forum will include scientists and representatives from industry, labor, and other stakeholders, and is open to the public. Attendance is limited only by the space available. The meeting room will accommodate approximately 60 people. Interested parties should make hotel reservations directly with the Sheraton Cincinnati Airport Hotel by calling toll free (888) 627-8418 before the cut-off date of 5 p.m. EDT April 8, 2008. A special group rate of $95 per night plus tax for meeting guests has been negotiated for this meeting. In order to receive the special room rate, you will need to indicate that you will be attending the NIOSH meeting. Interested parties should confirm their attendance to this meeting by contacting Ms. Kim Collins, meeting coordinator, at 513-841-4211 or firstname.lastname@example.org by April 15, 2008. Oral comments given at the meeting will be recorded and included in the NIOSH docket number 135. Written comments, including prepared oral comments, will also be accepted at the meeting or by submitting to the NIOSH Docket Office (see address below). Background: The goal of the healthcare worker survey is to collect information describing hazards, exposures, safety and health practices, and use of exposure controls by occupation and type and size of establishment. The goal of the management survey is to collect information describing facility-based health and safety resources, safety and health management programs, policies and practices for the same health and safety hazards covered in the worker survey, by type and size of establishment. Preliminary work on this effort included a feasibility study which was completed in 2006. The study assessed the feasibility of collecting self-reported information on health and safety practices from healthcare workers at their workplace. Worker and management questionnaires were developed (based on healthcare stakeholder input) and refined using focus groups/cognitive interviews, and pilot-tested at two large medical centers. Based on the pilot test findings, NIOSH decided that it would be more cost-effective to implement the worker survey as a web-based survey through various professional and labor organizations, rather than through employer establishments. The management questionnaire will be targeted to individuals responsible for facility health and safety, based on a representative sample of healthcare establishments. Although the content of the questionnaires has been fairly well-defined, information will be sought from meeting participants on other important or emerging healthcare safety and health issues for possible inclusion in the questionnaires, as well as other information (see below). The proposed worker and management questionnaires may be found at: http://www.cdc.gov/niosh/review/public/ 135. Contact Person for Technical Information: Jim Boiano (513) 841- 4246, or Karl Sieber (513) 841-4231. Comments on the topics presented in this notice and at the meeting should be mailed to the NIOSH Docket Office, Robert A. Taft Laboratories, MS-C34, 4676 Columbia Parkway, Cincinnati, Ohio, 45226, (513) 533-8611 or fax (513) 533-8285. Comments may also be submitted by e-mail to email@example.com or at http:// www.cdc.gov/niosh/review/public/135. All electronic comments should be formatted in Microsoft Word. All material submitted to the Agency should reference the NIOSH Docket number 135 and be submitted by July 1, 2008. After the comment period has closed, comments will be able to be accessed electronically at http://www.cdc.gov/NIOSH under the link to the NIOSH docket. As appropriate, NIOSH will post comments with the commenters' names, affiliations and other information, on the Internet. Reference: The proposed worker and management questionnaires may be found at: http://www.cdc.gov/niosh/review/public/135.
Implantation or Injectable Dosage Form New Animal Drugs; Enrofloxacin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Bayer HealthCare, LLC. The supplemental NADA provides for the use of enrofloxacin injectable solution in female dairy cattle less than 20 months of age.
Third-Party Certification Programs for Foods and Feeds; Request for Comments
The Food and Drug Administration (FDA) is requesting comments on the use of third-party certification programs for foods and feeds, including pet foods. An increasing number of firms that sell foods to the public, such as retailers and food service providers, are requesting that their suppliers become certified as meeting food (and feed) safety and quality standards as a condition of doing business. FDA seeks more information on the existence and use of these types of programs to better understand how they can help to ensure that food products are safe, secure, and meet FDA requirements.
National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of Employees at the Nuclear Materials and Equipment Corporation Site, Parks Township, PA, To Be Included in the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at the Nuclear Materials and Equipment Corporation site, Parks Township, Pennsylvania, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Nuclear Materials and Equipment Corporation. Location: Parks Township, Pennsylvania. Job Titles and/or Job Duties: All Atomic Weapons Employer employees. Period of Employment: June 1, 1960 through December 31, 1980.
Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee-May 21, 2008
This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MedCAC) (``Committee'') will be held on Wednesday, May 21, 2008. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services are reasonable and necessary under the Medicare statute. This meeting will focus on the design and methodological issues that challenge clinical research regarding innovative neurorehabilitation techniques. The meeting will discuss the various kinds of evidence that are useful to support requests for Medicare coverage in this field. This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).
Medicaid Program; Final State Allotments for Payment of Medicare Part B Premiums for Qualifying Individuals for Federal Fiscal Year 2007
This Notice sets forth the methodology and process used to compute and issue each State's final allotment for fiscal year (FY) 2007 that is available to pay Medicare Part B premiums for qualifying individuals.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-October Through December 2007
This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from October 2007 through December 2007, 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 tomogrogphy 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.
The Essentials of Food and Drug Administration Medical Device Regulations: A Primer for Manufacturers and Suppliers; Public Seminar
The Food and Drug Administration's (FDA's) Center for Devices and Radiological Health and Office of Regulatory Affairs, in cooperation with AdvaMed's Medical Technology Learning Institute, is announcing a series of three seminars on FDA medical device regulations. These 2-day seminars, which are designed to address the training needs of startup and small device manufacturers and their suppliers, will include both industry and FDA perspectives and a question and answer period. Dates: The seminars are planned for the following dates: 1. April 8 and 9, 2008, in Rosemont, IL 60018. Details about dates are posted on AdvaMed's Web site at: www.Advamedmtli.org/Chicago.\1\