Department of Health and Human Services September 2005 – Federal Register Recent Federal Regulation Documents

This notice informs eligible health care groups of an opportunity to apply to participate in the Medicare Health Care Quality demonstration. The goal of the demonstration is to improve the quality of care and services delivered to Medicare beneficiaries through a major system redesign that fosters best practice guideline usage, continuous quality and patient safety improvement, shared decision making between providers and patients, and the delivery of culturally and ethnically appropriate care. This notice contains information on how to obtain the complete solicitation and supporting information. A competitive process will be used to select 8 to 12 health care organizations (that is, physician group practices, integrated delivery systems, and regional coalitions of physician group practices and integrated delivery systems) to participate in the 5-year demonstration. The application solicitation will be conducted in two phases.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Requests for Inspection by an Accredited Person under the Inspection by Accredited Persons Program Authorized by Section 201 of the Medical Device User Fee and Modernization Act of 2002.'' The Medical Device User Fee and Modernization Act of 2002 authorizes FDA to establish a voluntary inspection program under which manufacturers of class II or class III devices who meet certain eligibility criteria as defined by the statute can elect to have FDA-accredited third parties conduct some of their establishment inspections instead of FDA. This guidance document describes the establishment eligibility criteria and the process for establishments to follow when requesting FDA's approval to have an accredited person (AP) conduct an inspection of their establishment instead of FDA under the new Inspections by Accredited Persons Program (AP Program).

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Experimental Study of Health Claims on Food Packages'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The 1998 Head Start Reauthorization (42 U.S.C. 9844(g); section 649(g)(1) of the Head Start Act, as amended) called on the Secretary of Health and Human Services to form an independent panel of experts (i.e., an Advisory Committee) to offer advice concerning research designs that would provide a national analysis of the impact of Head Start Programs. The September 28-29, 2005 meeting provides an opportunity for the Advisory Committee to provide advice on the analysis plans for the study following the June 2005 release on the first impact findings.

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 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 reclassification petitions for medical devices.

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.

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 a notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed survey of current manufacturing practices in the food industry. The purpose of the proposed survey is to improve FDA's understanding of current food industry manufacturing practices. The information will be used to assess what impact, if any, new manufacturing requirements would make on the food industry.

The Food and Drug Administration (FDA) is announcing a public hearing on direct-to-consumer (DTC) promotion of regulated medical products, including prescription drugs for humans and animals, vaccines, blood products, and medical devices. FDA is particularly interested in hearing the views of individuals and groups most affected by DTC promotion, including consumers, patients, caregivers, health professionals (physicians, physicians' assistants, dentists, nurses, pharmacists, veterinarians, and veterinarian technicians) managed care organizations, and insurers, as well as the regulated industry. FDA is seeking input on a number of specific questions, but is interested in any other pertinent information participants in the hearing would like to share. Dates and Times: The public hearing will be held on November 1 and 2, 2005, from 9 a.m. to 5 p.m. Submit written or electronic notices of participation by close of business on October 11, 2005. Written and electronic comments will be accepted until February 28, 2006. Location: The public hearing will be held at the National Transportation Safety Board Boardroom and Conference Center, 429 L'Enfant Plaza, SW., Washington, DC 20594, 202-314-6421; Metro: L'Enfant Plaza station on the green, yellow, blue, and orange lines; see: https://ntsb.gov/events/newlocation.htm. (FDA has verified the Web site address, but FDA is not responsible for any changes to the Web site after this document publishes in the Federal Register.) Addresses: Written or electronic notices of participation should be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, or on the Internet at https://www.accessdata.fda.gov/scripts/oc/dockets/ meetings/meetingdocket.cfm. Comments about the meeting or comments after the meeting should be submitted to https://www.fda.gov/dockets/ ecomments. Written or electronic comments can be submitted to https:// www.fda.gov/oc/dockets/ecomments. A consolidated list of all documents and other information related to the public hearing, such as the Federal Register notice, the agenda, public comments, and transcripts will be posted with their links, as the documents are made available, on the Center for Drug Evaluation and Research (CDER) Web site at https://www.fda.gov/cder/ddmac. For further information contact: Rose Cunningham, Center for Drug Evaluation and Research (HFD-006), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20852, 301-443-5595, e-mail: cunninghmar@cder.fda.gov. For registration to attend and/or to participate in the meeting: Seating at the hearing is limited. People interested in attending the meeting should register at https://www.accessdata.fda.gov/scripts/oc/ dockets/meetings/meetingdocket.cfm. Registration is free and will be accepted on a first-come, first-served basis. The procedures governing the hearing are found in part 15 (21 CFR part 15). Anyone wishing to make an oral presentation during the hearing must state this intention on the registration form (see Addresses). To participate, submit your name, title, business affiliation, address, telephone and fax numbers, and e-mail address. A written statement also should be submitted at the time of registration for each discussion question to be addressed, with the names and addresses of all individuals who plan to participate, and the approximate time requested for the presentation. The agency requests that interested persons and groups having similar interests consolidate their comments and present them through a single representative. Individuals who have registered to make an oral presentation will be notified of the scheduled time for their presentation prior to the hearing. Depending on the number of presentations, FDA may need to limit the time allotted for each presentation. FDA has identified questions and subject matter of special interest in section III of this document, but presentations do not have to be limited to those questions. Presenters should submit to the agency two copies of each presentation given. All participants are encouraged to attend the entire 2-day meeting. If special accommodations are needed because of a disability, the registration contact person should be informed at the time of registration.

The Food and Drug Administration (FDA) previously announced three public meetings entitled ``Vision 2006A Conversation With the American Public.'' These meetings are a forum where consumers can interact directly with FDA's leadership to discuss issues of public interest. Due to our need to focus on Hurricane Katrina relief efforts, we are postponing the meeting that was scheduled on September 13, 2005 in Miami, FL. We will reschedule the Miami meeting at a later date.

The Policy Committee of the 2005 White House Conference on Aging (WHCoA) announces the selection of At-Large Delegates to attend the 2005 WHCoA from December 11 through 14, 2005.

The Indian Health Service (IHS) announces the award of a cooperative agreement that will be funded on a competitive continuing basis to the National Native American Emergency Medical Services Association (NNAEMSA) for a demonstration project to improve emergency medical services for Native American people by improving communications between the IHS and the Native American Emergency Medical Services (EMS) providers; by improving communications and information among other federal agencies, professional organizations and Native American EMS providers; and by supporting an Annual Educational Conference. Project Period: The cooperative agreement is for a five-year project period effective on or about September 15, 2005 to September 14, 2010. Amount of Award(s): Total funding for the project is $450,000. Funding in the amount of $90,000.00 is available in FY 2005. Continuation awards within an approved project period will be made on the basis of satisfactory progress as evidenced by required reports and the availability of funds.

NICEATM announces a second meeting of an expert panel by teleconference on September 19, 2005, to evaluate (1) revised accuracy and reliability analyses of four in vitro test methods proposed for detecting ocular corrosives and severe irritants and (2) a revised list of proposed reference substances for validation studies on in vitro test methods for identifying ocular corrosives and severe irritants. The four in vitro test methods under consideration are the (1) Bovine Corneal Opacity and Permeability (BCOP) assay, (2) Hen's Egg Test Chorion Allantoic Membrane (HET-CAM), (3) Isolated Rabbit Eye (IRE) assay, and (4) Isolated Chicken Eye (ICE) assay. The revised analyses and revised list of proposed reference substances are available in an addendum to the draft Background Review Documents (BRDs) for the four methods (available at https://iccvam.niehs.nih.gov/methods/ocudocs/ reanalysis.htm). A previous Federal Register notice solicited public comment on the revised analyses and revised list of proposed reference substances (Vol. 70, No. 142, pg. 43149, July 26, 2005). Comments submitted in response to the July 26, 2005 Federal Register notice will be considered at the expert panel meeting and do not need to be resubmitted. The public is invited to attend the teleconference and will be provided with an opportunity to make oral comments during the public comment period. Interested individuals can attend the meeting via a phone line or in person at the NIEHS campus (see ADDRESSES below). Participation is limited only by the number of phone lines available and by the number of available seats at the teleconference site. Additional meeting information may be obtained on the ICCVAM/ NICEATM Web site (https://iccvam.niehs.nih.gov) or by contacting NICEATM (see ADDRESSES below).