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

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Guidance for Industry: Using Electronic Means to Distribute Certain Product Information,'' dated September 2005. The draft guidance explains that persons can distribute certain product information, such as for recalls and drug safety, by electronic means. We encourage the use of electronic communications for conveying all such important product safety information. We are making clear in this draft guidance that manufacturers may disseminate communications by e-mail or other electronic methods.

This document corrects technical errors that appeared in the general notice with comment period published in the Federal Register on September 23, 2005 entitled ``Medicare Program; Criteria and Standards for Evaluating Intermediary, Carrier, and Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Regional Carrier Performance During Fiscal Year 2006.''

This document corrects technical errors that appeared in the final rule published in the Federal Register on August 4, 2005, entitled ``Hospice Wage Index for Fiscal Year 2006.'' This document is effective on October 1, 2005, the effective date of the provisions of the final rule.

In this notice with public comment period, we announce the requests we have received from entities seeking review of the appropriateness of the Medicare payment amount for new technology lenses furnished by ambulatory surgical centers (ASCs). Interested parties submitted these requests for review in response to our May 27, 2005 Federal Register notice entitled ``Medicare Program; Calendar Year 2005 Review of the Appropriateness of Payment Amounts for New Technology Intraocular Lenses (NTIOLs) Furnished by Ambulatory Surgical Centers (ASCs).'' We received one timely application for review by the June 27, 2005 due date listed in that Federal Register notice. In this notice with comment period, we summarize the timely application received and solicit public comments on the one intraocular lens (IOL) under review.

This interim final rule with comment period sets forth the criteria for implementing a loan program for qualifying hospitals engaged in research in the causes, prevention, and treatment of cancer as specified in section 1016 of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA) (Pub. L. 108-173). Specifically, this rule establishes a loan application process by which qualifying hospitals including specified entities may apply for a loan for the capital costs of health care infrastructure improvement projects.

The Food and Drug Administration (FDA) is adding noncompression heart stabilizers to the list of critical reprocessed single-use devices (SUDs) whose exemption from premarket notification requirements has been terminated and for which validation data, as specified under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), are necessary in a premarket notification (510(k)). The agency is also adding laparoscopic and endoscopic electrosurgical accessories to the list of reprocessed SUDs currently subject to premarket notification requirements that will now require submission of supplemental validation data. FDA is requiring submission of these data to ensure that reprocessed single-use noncompression heart stabilizers and laparoscopic and endoscopic electrosurgical accessories are substantially equivalent to predicate devices, in accordance with MDUFMA.

This final notice describes and finalizes the procedure, which was previously published in the Federal Register on January 19, 2005 (70 FR 3036) as a notice with comment period, for redistribution of States' unexpended Federal fiscal year (FY) 2002 SCHIP allotments remaining at the end of FY 2004 to those States that fully expended the allotments. These redistributed allotments will be available through the end of FY 2005 (September 30, 2005).

This notice announces the selection of the American Health Information Community (the Community) members in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.) The following individuals have been selected by the Secretary to serve on the American Health Information Community. From the private sector listed alphabetically: Craig R. Barrett, Chairman, Intel Corporation, Nancy Davenport-Ennis, CEO, National Patient Advocate Foundation, Lillee Smith Gelinas, R.N., Chief Nursing Officer, VHA Inc., Douglas E. Henley, M.D., Executive Vice President, American Academy of Family Physicians, Kevin D. Hutchinson, CEO, SureScripts, Charles N. Kahn III, President, Federation of American Hospitals, Steven S. Reinemund, CEO and Chairman, PepsiCo, Scott P. Serota, President and CEO, Blue Cross Blue Shield Association. From the public sector listed alphabetically: Julie Louise Gerberding, M.D., Director Centers for Disease Control and Prevention, Mark B. McClellan, M.D. Administrator, Centers for Medicare and Medicaid Services, Michelle O'neill, Acting Under Secretary for Technology, Department of Commerce, Jonathan B. Perlin, M.D., Under Secretary for Health, Department of Veterans Affairs, E. Mitchell Roob, Secretary, Indiana Family and Social Services Administration, Linda M. Springer, Director, Office of Personnel Management, Mark J. Warshawsky, Assistant Secretary for Economic Policy, Department of the Treasury, William Winkenwerder Jr., M.D., Assistant Secretary of Defense, Department of Defense.

Pursuant to Public Law 92-463, the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the ninth meeting of the Advisory Committee on Organ Transplantation (ACOT), Department of Health and Human Services (HHS). The meeting will be held from approximately 9 a.m. to 5:30 p.m. on November 3, 2005, and from 9 a.m. to 3 p.m. on November 4, 2005, at the Rockville DoubleTree Hotel, 1750 Rockville Pike, Rockville, Maryland 20852. The meeting will be open to the public; however, seating is limited and pre-registration is encouraged (see below).

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 providing notice of a memorandum of understanding (MOU) between the Food and Drug Administration and the Federal Bureau of Investigation (FBI). The purpose of this MOU is to establish the general policies and procedures that will govern administrative, logistical, and operational support to FBI missions including cost reimbursable activities.

The Department of Health and Human Services (HHS) gives notice of a decision to designate a class of employees at the Y-12 facility, in Oak Ridge, Tennessee as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On August 25, 2005, the Secretary of HHS designated the following class of employees as an addition to the SEC: Department of Energy (DOE) employees or DOE contractor or subcontractor employees who worked in uranium enrichment operations or other radiological activities at the Y-12 facility in Oak Ridge, Tennessee from March 1943 through December 1947 and who were employed for a number of work days aggregating at least 250 work days, either solely under this employment or in combination with work days of employment occurring within the parameters (excluding aggregate work day requirements) established for other classes of employees included in the SEC. This designation will become effective on September 24, 2005, unless Congress provides otherwise prior to the effective date. After this effective date, HHS will publish a notice in the Federal Register reporting the addition of this class to the SEC or the result of any provision by Congress regarding the decision by HHS to add the class to the SEC.

The Minor Use and Minor Species Animal Health Act of 2004 (MUMS act) amended the Federal Food, Drug, and Cosmetic Act (the act) to establish new regulatory procedures that provide incentives intended to make more drugs legally available to veterinarians and animal owners for the treatment of minor animal species and uncommon diseases in major animal species. At this time, FDA is issuing proposed regulations to implement the act. These regulations propose procedures for designating a new animal drug as a minor use or minor species drug. Such designation establishes eligibility for the incentives provided by the MUMS act.

The Food and Drug Administration (FDA) is announcing that the following two petitions have been filed: A petition requesting that the agency revoke the standards of identity for goat's milk ice cream and mellorine, and amend the standards of identity for ice cream and frozen custard, sherbet, and water ices in numerous respects; and a petition requesting that the agency amend the standard of identity for parmesan and reggiano cheese to decrease the minimum curing time from 10 months to 6 months. The FDA is issuing an advance notice of proposed rulemaking (ANPRM) to request comments to determine whether the action proposed in the petitions would promote honesty and fair dealing in the interest of consumers.

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 the following public meeting: A New Direction for FDA's Radiological Health Program. The topics of discussion are the agency's activities to implement its radiological health program (the program).

This document corrects a technical error that appeared in the proposed rule published in the Federal Register on August 26, 2005 entitled ``Medicaid Program; Disproportionate Share Hospital Payments.''

The Food and Drug Administration (FDA) is announcing a public meeting entitled ``Preparation for ICH meetings in Chicago, Illinois'' to provide information and receive comments on the International Conference on Harmonization (ICH) as well as the upcoming meetings in Chicago, IL. The topics to be discussed are the topics for discussion at the forthcoming ICH Steering Committee Meeting. The purpose of the meeting is to solicit public input prior to the next Steering Committee and Expert Working Groups meetings in Chicago, IL, November 7 through 10, 2005, at which discussion of the topics underway and the future of ICH will continue. Date and Time: The meeting will be held on October 20, 2005, from 1:30 p.m. to 4 p.m. Location: The meeting will be held at 5600 Fishers Lane, 3rd Fl., Maryland Conference Room, Rockville, MD 20857. For security reasons, all attendees are asked to arrive no later than 1:25 p.m., as you will be escorted from the front entrance of 5600 Fishers Lane to the Maryland Conference Room. Contact: Sema Hashemi, Office of the Commissioner (HFG-1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827- 3050, FAX: 301-480-0716, e-mail: Sema.Hashemi@fda.hhs.gov. Registration and Requests for Oral Presentations: Send registration information (including name, title, firm name, address, telephone, and fax number), written material and requests to make oral presentations, to the contact person by October 14, 2005. If you need special accommodations due to a disability, please contact Sema Hashemi at least 7 days in advance.

This rule proposes standards for electronically requesting and supplying particular types of additional health care information in the form of an electronic attachment to support submitted health care claims data. It would implement some of the requirements of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996.

In accordance with section 10(a) of the Federal Advisory Committee Act (FACA) (5 U.S.C. Appendix 2), this notice announces the third meeting of the Emergency Medical Treatment and Labor Act (EMTALA) Technical Advisory Group (TAG). The purpose of the EMTALA TAG is to review regulations affecting hospital and physician responsibilities under EMTALA to individuals who come to a hospital seeking examination or treatment for medical conditions. The primary purpose of the third meeting is to enable the EMTALA TAG to hear additional testimony and further consider written responses from medical societies and other organizations on specific issues considered by the TAG at previous meetings. However, the public is permitted to attend this meeting and, to the extent that time permits and at the discretion of the Chairperson, the EMTALA TAG may hear comments from the floor.

This notice describes the criteria and standards to be used for evaluating the performance of fiscal intermediaries (FIs), carriers, and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) regional carriers in the administration of the Medicare program beginning on the first day of the first month following publication of this notice in the Federal Register. The results of these evaluations are considered whenever we enter into, renew, or terminate an intermediary agreement, carrier contract, or DMEPOS regional carrier contract or take other contract actions, for example, assigning or reassigning providers or services to an intermediary or designating regional or national intermediaries. We are requesting public comment on these criteria and standards.

This annual notice announces Medicare's Hospital Insurance (Part A) premium for uninsured enrollees in calendar year (CY) 2006. This premium is to be paid by enrollees age 65 and over who are not otherwise eligible (hereafter known as the ``uninsured aged'') and for certain disabled individuals who have exhausted other entitlement. The monthly Part A premium for the 12 months beginning January 1, 2006 for these individuals will be $393. The reduced premium for certain other individuals as described in this notice will be $216. Section 1818(d) of the Social Security Act specifies the method to be used to determine these amounts.

This notice announces the monthly actuarial rates for aged (age 65 and over) and disabled (under age 65) beneficiaries enrolled in Part B of the Medicare Supplementary Medical Insurance (SMI) program beginning January 1, 2006. In addition, this notice announces the monthly premium for aged and disabled beneficiaries and the annual deductible to be paid during 2006. The monthly actuarial rates for 2006 are $176.90 for aged enrollees and $203.70 for disabled enrollees. The monthly Part B premium rate for 2006 is $88.50 which is equal to 50 percent of the monthly actuarial rate for aged enrollees or about 25 percent of Part B costs for aged enrollees. (The 2005 premium rate was $78.20.) The Part B deductible for 2006 is $124.00.

The Food and Drug Administration (FDA) is withdrawing approval of 13 new drug applications (NDAs) from multiple holders of these applications. The basis for the withdrawals is that the holders of the applications have repeatedly failed to file required annual reports for the applications.

The Food and Drug Administration (FDA) Dallas District, in cooperation with the Society of Clinical Research Associates (SoCRA), is announcing a workshop on FDA clinical trial statutory and regulatory requirements. This 2-day workshop for the clinical research community targets sponsors, monitors, clinical investigators, institutional review boards, and those who interact with them for the purpose of conducting FDA-regulated clinical research. The workshop will include both industry and FDA perspectives on proper conduct of clinical trials regulated by FDA. Date and Time: The public workshop is scheduled for Wednesday, February 8, 2006, from 8:15 a.m. to 5 p.m. and Thursday, February 9, 2006, from 8:15 a.m. to 4 p.m. Location: The public workshop will be held at the Crowne Plaza Hotel Houston Medical Center, 6701 South Main, Houston, TX 77030, 713- 797-1110, FAX: 713-796-8291. Contact: David Arvelo, Food and Drug Administration, 4040 North Central Expressway, suite 900, Dallas, TX 75204, 214-253-4952, FAX: 214-253-4970, e-mail: oraswrsbr@ora.fda.gov. Registration: Send registration information (including name, title, firm name, address, telephone, and fax number) and the registration fee of $485 (member), $560 (nonmember), or $460 (government employee nonmember). (Registration fee for nonmembers includes a 1-year membership.) The registration fee for FDA employees is waived. Make the registration fee payable to SoCRA, P.O. Box 101, Furlong, PA 18925. To register via the Internet go to https://www.socra.org/html/FDA Conference.htm (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register). The registrar will also accept payment by major credit cards. For more information on the meeting, or for questions on registration, contact 800-SoCRA92 (800-762-7292), or 215-345-7369, or via e-mail: socramail@aol.com. Attendees are responsible for their own accommodations. To make reservations at the Crowne Plaza Hotel Houston Medical Center at the reduced conference rate, contact the Crowne Plaza Hotel Houston Medical Center (see Location) before January 17, 2005. The registration fee will be used to offset the expenses of hosting the conference, including meals, refreshments, meeting rooms, and materials. Space is limited, therefore interested parties are encouraged to register early. Limited onsite registration may be available. Please arrive early to ensure prompt registration. If you need special accommodations due to a disability, please contact David Arvelo (see Contact) at least 7 days in advance of the workshop.

Notice is hereby given that a noncompetitive single source program expansion supplement to an ongoing competitive award is being made to the United States Conference of Catholic Bishops (USCCB) in response to an unsolicited application. The application is not within the scope of any existing or expected to be issued program announcement for the Fiscal Year 2006. USCCB's application is expected to address issues critical to the development and implementation of marriage education programs for refugees by opening three new program sites. In September of 2003, ORR awarded USCCB a grant of $1,000,000,000 to develop a Refugee Family Enrichment program which included technical assistance to subgrantees. Over the past two years, USCCB has established an effective program in sites that have successfully prepared thousands of refugee families for the challenges they will face during resettlement. Because other Refugee Marriage Enrichment grantees are primarily regional in scope, we believe USCCB is uniquely suited to effectively implement this supplemental award. USCCB has affiliates across the country and has no physical or programmatic limitations regarding which ethnic groups they can serve. We believe that by allowing them to increase the number of sites, that it would be a cost-effective way of helping more refugees develop the skills that help their marriages succeed and give their children a better chance of success in the U.S. Without it, these sites might struggle to provide refugee clients with the programs they need in order to achieve self-sufficiency. The proposed project period is 9/30/2005-9/29/2006. Assistance to support grantees in developing better approaches to the delivery of services provided to refugees is authorized by section 412(c)(1)(A) of the Immigration and Nationality Act (8 U.S.C. 1522(c)(1)).

The invention named in this notice is owned by agencies of the United States Government and is available for licensing in the United States (U.S.) in accordance with 35 U.S.C. 207, and is available for cooperative research and development agreements (CRADAs) in accordance with 15 U.S.C. 3710a, to achieve expeditious commercialization of results of federally funded research and development. A U.S. non- provisional patent application and a PCT application have been filed. National stage foreign patent applications claiming priority to the PCT application are expected to be filed within the appropriate deadlines to extend market coverage for U.S. companies and may also be available for licensing.

The Food and Drug Administration (FDA) is classifying the oral rinse to reduce the adhesion of dental plaque device into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Class II Special Controls Guidance Document: Oral Rinse to Reduce the Adhesion of Dental Plaque.'' The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.

The Food and Drug Administration (FDA) Cincinnati District, in cooperation with the Society of Clinical Research Associates (SoCRA), is announcing a workshop on FDA clinical trial statutory and regulatory requirements. This 2-day workshop for the clinical research community targets sponsors, monitors, clinical investigators, institutional review boards, and those who interact with them for the purpose of conducting FDA-regulated clinical research. The workshop will include both industry and FDA perspectives on proper conduct of clinical trials regulated by FDA. Date and Time: The public workshop will be held on Wednesday, December 7, 2005, from 8:15 a.m. to 5 p.m. and Thursday, December 8, 2005, from 8:15 a.m. to 4 p.m. Location: The public workshop will be held at The Westin Cincinnati, 21 East 5th St., Cincinnati, OH 45202-3160, 513-621-7700, FAX: 513-852-5670. Contact: Marie Falcone, Food and Drug Administration, rm. 900, U.S. Customhouse, 200 Chestnut St., Philadelphia, PA 19106, 215-717-3703, FAX: 215-597-5798, e-mail: mfalcone@ora.fda.gov. Registration: Send registration information (including name, title, firm name, address, telephone, and fax number), and the registration fee of $485 (member), $560 (nonmember), or $460 (government employee nonmember) (includes a 1-year membership). The registration fee for FDA employees is waived. Make the registration fee payable to SoCRA, P.O. Box 101, Furlong, PA 18925. To register via the Internet go to https:// www.socra.org/FDAConference.htm. (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.) The registrar will also accept payment by major credit cards. For more information on the meeting, or for questions on registration, contact 800-SoCRA92 (800-762-7292), or 215-345-7749, or FAX: 215-345- 7369, or e-mail: socramail@aol.com. Attendees are responsible for their own accommodations. To make reservations at The Westin Cincinnati at the reduced conference rate, contact The Westin Cincinnati see Location) through November 7, 2005, or until the SoCRA room block is full. The registration fee will be used to offset the expenses of hosting the conference, including meals, refreshments, meeting rooms, and materials. Space is limited, therefore interested parties are encouraged to register early. Limited onsite registration may be available. Please arrive early to ensure prompt registration. If you need special accommodations due to a disability, please contact Marie Falcone at least 7 days in advance of the workshop.

The Food and Drug Administration (FDA) is issuing proposed regulations on current good manufacturing practice (CGMP) for positron emission tomography (PET) drug products. The regulations are intended to ensure that PET drug products meet the requirements of the Federal Food, Drug, and Cosmetic Act (the act) regarding safety, identity, strength, quality, and purity. We are proposing to establish CGMP requirements for approved PET drug products. For investigational and research PET drugs, the proposed rule states that the requirement to follow CGMP may be met by producing PET drugs in accordance with the United States Pharmacopeia (USP) general chapter on compounding PET radiopharmaceuticals. We are proposing to establish these CGMP requirements for all PET drugs under the provisions of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the draft guidance entitled ``PET Drug Products Current Good Manufacturing Practice (CGMP).''

In accordance with the requirements of the Privacy Act of 1974, we are proposing to create a new SOR titled, ``Carotid Artery Stenting (CAS) System, System No. 09-70-0556.'' National coverage determinations (NCDs) are determinations by the Secretary with respect to whether or not a particular item or service is covered nationally under title XVIII of the Social Security Act (the Act) section 1869(f) (1) (B). In order to be covered by Medicare, an item or service must fall within one or more benefit categories contained within part A or part B, and must not be otherwise excluded from coverage. Moreover, with limited exceptions, the expenses incurred for items or services must be ``reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.'' section 1862(a) (1) (A). CMS has determined that the evidence is adequate to conclude that CAS with embolic protection is reasonable and necessary to symptomatic patients who are at high risk for carotid endarterectomy (CEA), have significant comorbidities, or have anatomic risk factors. The reasonable and necessary determination requires that patients meet the criteria and are consistent with the trials discussed. Collection of these data elements allows that determination to be made. The purpose of this system is to collect and maintain data on patients to review determinations of ``reasonable and necessary'' with respect to CAS in patients who are at high risk for CEA. Information retrieved from this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor or consultant; (2) assist another Federal or state agency with information to enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) to an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (4) support constituent requests made to a congressional representative; (5) support litigation involving the agency; and (6) combat fraud and abuse in certain health benefits programs. We have provided background information about the modified system in the ``Supplementary Information'' section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See Effective Dates section for comment period.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Collection of Race and Ethnicity Data in Clinical Trials.'' This guidance provides recommendations on a standardized approach for collecting and reporting race and ethnicity information in clinical trials conducted in the United States and abroad for certain FDA regulated products. This document provides guidance on meeting the requirements in the 1998 final rule on Investigational New Drug Applications and New Drug Applications (Demographic Rule) (63 FR 6854, February 11, 1998).

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between the Food and Drug Administration, Center for Biologics Evaluation and Research (FDA/ CBER), and the National Institutes of Health, National Institute of Neurological Disorders and Stroke (NIH/NINDS). The purpose of this MOU is to provide a framework for coordination and collaborative efforts between these two entities, which are both components of the Department of Health and Human Services. This MOU also provides the principles and procedures by which information sharing between FDA/CBER and NIH/NINDS units shall take place.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Acne Vulgaris: Developing Drugs for Treatment.'' This document has been developed to provide guidance on the development of drug products for the treatment of acne vulgaris other than nodulocystic acne.

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).