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

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes a nonclinical testing strategy for assessing the potential of a test substance to delay ventricular repolarization and includes information concerning nonclinical assays and an integrated risk assessment. The guidance is intended to facilitate the nonclinical assessment of the effects of pharmaceuticals on ventricular repolarization and proarrhythmic risk.

We are adding reconstructed replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight gene segments to the list of HHS select agents and toxins. We are taking this action for several reasons. First the pandemic influenza virus of 1918-19 killed up to 50 million people worldwide, including an estimated 675,000 deaths in the United States. Also, the complete coding sequence for the 1918 pandemic influenza A H1N1 virus was recently identified, which will make it possible for those with knowledge of reverse genetics to reconstruct this virus. In addition, the first published study on a reconstructed 1918 pandemic influenza virus demonstrated the high virulence of this virus in cell culture, embryonated eggs, and in mice relative to other human influenza viruses. Therefore, we have determined that the reconstructed replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight gene segments have the potential to pose a severe threat to public health and safety.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to modify or alter a SOR titled, ``Medicare Managed Care System (MMCS), No. 09-70-4001.'' MMCS processes beneficiary enrollment and creates beneficiary level payments for the Managed Care Organizations (MCO). We propose to broaden the scope of this system by adding the Medicare Part D Program under Title XVIII. The Medicare+Choices Program has been changed to the Medicare Advantage (MA) Program. The MA was mandated by the Balance Budget Act (BBA) of 1997 (Public Law (Pub. L.) 105-33). To more accurately reflect the changes proposed for this system, we will modify the name to read: ``Medicare Advantage Prescription Drug (MARx) System.'' The enhanced system will continue to perform all current MMCS processing requirements. In addition, MARx will be a stand alone system that will include the processing of all enrollment/disenrollment transactions associated with the Part D Program. MARx will include the following: Health Maintenance Organizations (HMO), Health Care Prepayment Plan (HCPP), Medicare Advantage Organizations (MAO), Medicare Advantage Prescription Drug (MAPD) Plans and Prescription Drug Plans (PDP). On December 8, 2003, Congress passed the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108- 173). MMA amends the Social Security Act (the Act) by adding the Medicare Part D Program under Title XVIII and mandate that CMS establish a voluntary Medicare prescription drug benefit program effective January 1, 2006. Under the new Medicare Part D benefit, the Act allows Medicare payment to MA plans that contract with CMS to provide qualified Part D prescription drug coverage as described in 42 Code of Federal Regulations (CFR) 417 and 422. We are modifying the language in some of the routine uses to provide clarity to CMS's intention to disclose individual-specific information contained in this system. The routine uses will remain prioritized according to their proposed usage. Information previously retrieved from the Enrollment Database (System No. 09-70-0502) will now be retrieved by the Medicare Beneficiary Database (MBD) (System No. 09- 70-0536). We will also take the opportunity to update any sections of the system that were affected by the recent reorganization and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of the SOR is to maintain a master file of MA and MAPD plan members for accounting and payment control; expedite the exchange of data with MA and MAPD; control the posting of pro-rata amounts to the Part B deductible of currently enrolled MA members; and track participation of the prescription drug benefits provided under private prescription drug plans and Medicare employer plans. Information in this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed by a contractor or consultant contracted by the Agency; (2) support another Federal or State agency, agency of a state government, an agency established by state law, or its fiscal agent; (3) assist provider and suppliers of service directly or dealing through contractors, fiscal intermediaries (FI) or carriers for the administration of Title XVIII; (4) assist third party contacts in situations where the party to be contacted has, or is expected to have information relating to the individual's capacity to manage his or her affairs; (5) assist insurance companies, third party administrators, employers, self- insurers, managed care organizations, and other supplemental insurers; (6) facilitate research on the quality and effectiveness of care provided, as well as payment-related projects; (7) support constituent requests made to a congressional representative; (8) support litigation involving the Agency, and (9) 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.

Pursuant to Section 10(a) of the Federal Advisory Committee Act as amended (5 U.S.C. Appendix 2), notice is hereby given of the eighth Policy Committee meeting concerning planning for the 2005 White House Conference on Aging. The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should inform the contact person listed below in advance of the meeting. This notice is being published less than 15 days prior to the meeting due to scheduling problems.

In compliance with the requirement of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), 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. The proposed information collection below was previously published in the Federal Register on May 18, 2005, page 28544-28545 and allowed 60-days for public comment. No public comments 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 after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: 5 A Day Customized Survey. Type of Information Collection Request: New. Need and Use of Information Collection: The purpose of the 5 A Day Customized Survey is to further the development of standardized measures of consumer knowledge, attitudes, and behaviors regarding the consumption of fruits and vegetables. Specifically, the Customized Survey will allow for validation of the new ``cup'' portion sizes (consistent with the 2005 Dietary Guidelines) and identify the most efficacious short screener methods of fruit and vegetable intake. In addition, the Customized Survey will measure established predictors of fruit and vegetable consumption at the national level and explore new predictors and constructs not previously examined for fruit and vegetable consumption. The sample will be drawn from a consumer opinion panel methodology using balancing techniques to mirror the U.S. general population on a set of key demographic variables. A separate sample of African Americans will be drawn from the panel. Prior to fielding the Customized Survey, two pilot studies will be completed as the first phase of this research. Pilot respondents will be drawn from the same consumer panel and have similar demographics as respondents in the main study. A brief description of the two pilot studies follows. In pilot study 1, respondents will initially complete a brief screener questionnaire, three 24-hour dietary recalls over the phone, followed by the Customized Survey by mail. To account for diversity in eating habits, dietary recalls will be obtained for 2 weekdays and 1 weekend per respondent. The recalls will be conducted via phone by trained interviewers using the University of Minnesota's Nutrition Data System (NDS). After completing the dietary recalls pilot respondents will be mailed the Customized Survey within 2 weeks. Fruit and vegetable consumption as assessed by the average of the three 24- hour recalls will be compared with the fruit and vegetable consumption measures from the Customized Survey. In pilot study 2, respondents will complete the Customized Survey by mail at two points in time, six to eight weeks apart. The analysis in pilot study 2 will focus on a rigorous evaluation of the psychometric properties of the Customized Survey instrument to ensure that item-level and instrument-level reliability and validity has been achieved before proceeding to the main data collection phase of the study. Based on the findings of the pilot studies, minor modifications may be made to the Customized Survey prior to the implementation of the main study. Frequency of response: Main study, one time response (5 A Day Customized Survey). Pilot study 1, five times (screener, three 24-hour dietary recalls, 5 A Day Customized Survey). Pilot study 2, two times (5 A Day Customized Survey at two points in time). Affected Public: Individuals. Type of Respondents: U.S. adults. The annual reporting burden is as follows: Estimated Number of Respondents: 5,875; Estimated Number of Responses per Respondent: 1, 2 or 5; Average Burden Hours per Response: .416; and Estimated Total Annual Burden Hours Requested: 2,467.90. The annualized cost to respondents is estimated at: $46,384.28. The annual reporting burden is summarized in exhibit 1 below. There are no Operating or Maintenance Costs to report.

The NTP invites public comments on an updated list of nominations proposed for review in the 12th RoC and the nomination of scientists who have expertise and/or knowledge relevant to the evaluation of carcinogenicity for these nominations (see SUPPLEMENTARY INFORMATION). Information on the nominations under consideration for the RoC can be obtained at the NTP Web site https://ntp.niehs.nih.gov (select ``Report on Carcinogens'') or by contacting Dr. C.W. Jameson at the address provided below.

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 Ames Laboratory, on the Iowa State University Campus, Ames, Iowa, 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:

Title 5, U.S. Code, Section 4314(c)(4) of the Civil Service Reform Act of 1978, Public Law 95-454, requires that appointment of Performance Review Board members be published in the Federal Register.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new SOR titled, ``Fluoro-Deoxy Glucose (FDG) Positron Emission Tomography (PET) for Dementia and Neurodegenerative Diseases (DND) (PET DND), HHS/CMS/OCSQ, System No. 09-70-0561.'' National Coverage Determinations are determinations by the Secretary (HHS) 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 in Part A or Part B, and must not be otherwise excluded from coverage. In our review of DND indications, we found sufficient evidence to determine that PET scans are no longer experimental. However, the evidence was insufficient to reach a conclusion that FDG PET is reasonable and necessary in all instances. A sufficient inference of benefit, however, can be drawn to support limited coverage if certain safeguards for patients are provided. This inference is based on both the physiological basis for FDG PET usefulness in a differential diagnosis of fronto-temporal dementia (FTD) and Alzheimer's disease (AD), as well as, evidence of a positive benefit of PET for patients with several other dementing neurodegenerative diseases for which there is evidence of sufficient quality to warrant coverage. The purpose of this system is to collect and maintain information on Medicare beneficiaries receiving FDG PET scans for indications for DND when there is not sufficient evidence to reach a firm conclusion that the scan is reasonable and necessary unless they are enrolled in an approved study. Information retrieved from this system will 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) support 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 new 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 Date section for comment period.

In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed information collection projects, the Indian Health Service (IHS) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection list below. This proposed information collection project was published in the August 3, 2005, Federal Register (70 FR 44662) and allowed 60 days for public comment. No public comment was received in response to the notice. The purpose of this notice is to allow 30 days for public comment to be submitted to OMB. Proposed Collection: Title: 0917-0014, ``Indian Health Service Loan Repayment Program''. Type of Information Collection Request: Extention of a currently approved collection which expires December 31, 2005. Form Number: No reporting forms required. Need and Use of Information Collection: The IHS Loan Payment Program (LRP) identifies health professionals with pre-existing financial obligations for education expenses that meet program criteria and who are qualified and willing to serve at, often remote, IHS health care facilities. Under the program, eligible health professionals sign a contract under which the IHS agrees to repay part or all of their indebtedness for professional training education. In exchange, the health professionals agree to serve for a specified period of time in IHS health care facilities. Eligible health professionals that wish to apply must submit an application to participate in the program. The application requests personal, demographic and educational training information, including information on the educational loans of the individual for which repayment is being requested (i.e., date, amount, account number, purpose of each loan, interest rate, the current balance, etc). The data collected is needed and used to evaluate applicant eligibility; rank and prioritize applicants by specialty; assign applicants to IHS health care facilities; determine payment amounts and schedules for paying the lending institutions; and to provide data and statistics for program management review and analysis. Affected Public: Individual and households. Type of Respondents: Individuals. Table 1 below provides the following: Types of data collection instruments, estimated number of respondents, number of responses per respondent, annual number of responses, average burden hour per response, and total annual burden hour.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Compliance With Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amendedProminent and Conspicuous Mark of Manufacturers on Single-Use Devices.'' The Medical Device User Fee and Modernization Act of 2002 (MDUFMA), as amended by the Medical Device User Fee Stabilization Act of 2005 (MDUFSA), requires that FDA issue guidance within 180 days of enactment (August 1, 2005) identifying the circumstances in which the name, abbreviation, or symbol identifying the manufacturer of an original device is not ``prominent and conspicuous.''

As required by section 101 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), this proposed rule would create an exception to the physician self-referral prohibition in section 1877 of the Social Security Act (the Act) for certain arrangements in which a physician receives necessary non-monetary remuneration that is used solely to receive and transmit electronic prescription drug information. In addition, using our separate legal authority under section 1877(b)(4) of the Act, we are proposing two separate regulatory exceptions for electronic health records software and directly related training services. These exceptions are consistent with the President's goal of achieving widespread adoption of interoperable electronic health records for the purpose of improving the quality and efficiency of health care, while maintaining the levels of security and privacy that consumers expect.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, and Forms FDA 356h and 2567'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is amending the final monograph (FM) for over-the-counter (OTC) nasal decongestant drug products (drug products used to relieve nasal congestion due to a cold, hay fever, or other upper respiratory allergies) to remove the indication ``for the temporary relief of nasal congestion associated with sinusitis'' and to prohibit use of the terms ``sinusitis'' and ``associated with sinusitis'' elsewhere on the labeling. This final rule is part of FDA's ongoing review of OTC drug products.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 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 license to practice the following invention as embodied in the following patent applications: HHS Ref. No. E-047-2005; U.S. Provisional Patent Application Number 60/684,811, filed on May 25, 2005 to N&N Scientific, having a place of business in Maryland but incorporated in Illinois. The patent rights in these inventions have been assigned to the United States of America.

This notice announces a public meeting of the Medicaid Commission. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)). The Medicaid Commission will advise the Secretary on ways to modernize the Medicaid program so that it can provide high-quality health care to its beneficiaries in a financially sustainable way.

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 goal of this final rule is to increase immunization rates in Medicare and Medicaid participating long term care (LTC) facilities by requiring LTC facilities to offer each resident immunization against influenza annually, as well as lifetime immunization against pneumococcal disease. LTC facilities will be required to ensure that before offering the immunization, each resident or the resident's legal representative receives education regarding the benefits and potential side effects of immunization. The facilities will be required to offer immunization against influenza annually and immunization against pneumococcal disease once, unless medically contraindicated or the resident or the resident's legal representative refuses immunization. Increasing the use of Medicare-funded preventive services is a goal of both CMS and the Centers for Disease Control and Prevention (CDC). This final rule is intended to increase the number of elderly receiving influenza and pneumococcal immunization and decrease the morbidity and mortality rate from influenza and pneumococcal diseases.

The Food and Drug Administration (FDA) is proposing to amend the agency's regulations to prohibit the use of certain cattle origin materials in the food or feed of all animals. These materials include the following: The brains and spinal cords from cattle 30 months of age and older, the brains and spinal cords from cattle of any age not inspected and passed for human consumption, the entire carcass of cattle not inspected and passed for human consumption if the brains and spinal cords have not been removed, tallow that is derived from the materials prohibited by this proposed rule that contains more than 0.15 percent insoluble impurities, and mechanically separated beef that is derived from the materials prohibited by this proposed rule. These measures will further strengthen existing safeguards designed to help prevent the spread of bovine spongiform encephalopathy (BSE) in U.S. cattle.

The Food and Drug Administration (FDA) Philadelphia District, in cooperation with AdvaMed's Medical Technology Learning Institute, is announcing a public workshop on FDA device regulations. This 1 1/2-day public workshop for start up and small device manufacturers and their suppliers will include both industry and FDA perspectives and a question and answer period. Date and Time: The public workshop will be held on Tuesday, October 11, 2005, from 8:30 a.m. to 5:30 p.m. and Wednesday, October 12, 2005, from 8:30 a.m. to 12 noon. Location: The public workshop will be held at The Wyndham Philadelphia at Franklin Plaza, 17th and Race St., Philadelphia, PA 19103, 215-448-2000. For further hotel information and driving directions, go to https://www.wyndham.com/hotels/PHLFP. (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.) Contact: For FDA: Judy Summers-Gates, Food and Drug Administration, rm. 900, U.S. Customhouse, 200 Chestnut St., Philadelphia, PA 19106, 215-717- 3008, FAX: 215-597-4660, e-mail: judith.summers-gates@fda.gov. For AdvaMed: Krystine McGrath, 202-434-7237, FAX: 202-783-8750, kmcgrath@advamed.org; or Dia Black, 202-434-7231, FAX: 202-783-8750, e- mail: dblack@avamed.org. Registration: Send registration information (including name, title, firm name, address, telephone, and fax number), and the registration fee of $350 per person to the AdvaMed contacts (see Contact). The registration fee for FDA employees is waived. To register via the Internet go to https://www.advamed.org/philadelphia. (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.) Payment forms accepted are major credit card (MasterCard, Visa, or American Express) or company check. If you wish to pay by check contact Krystine McGrath (see Contact). For more information on the meeting, or for questions on registration, contact Krystine McGrath or Dia Black (see Contact). Attendees are responsible for their own accommodations. The registration fee will be used to offset the expenses of hosting the workshop, including meals (breakfasts and a lunch), refreshments, meeting rooms, and training materials. It also includes a networking reception on Tuesday, October 11, 2005. Space is limited, therefore interested parties are encouraged to register early. There will be no onsite registration. If you need special accommodations due to a disability, please contact Judy Summers-Gates at least 7 days in advance of the workshop.

CMS proposes to delete 14 systems of records from its inventory subject to the Privacy Act of 1974 (Title 5 United States Code 552a).

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled ``Medicare Physician Group Practice Demonstration (PGPD),'' System No. 09-70-0559. The PGPD tests a payment methodology for physician practices that combines Medicare fee-for-service payments with performance-based payments for improvements in patient management and quality of care. Improvements in these areas are expected to generate savings to the Medicare program to offset the costs of the performance payments. Mandated by Section 412 of the Benefits Improvement & Protection Act of 2000, the PGPD seeks to provide incentives for physicians to adopt care management strategies and to improve quality as defined by key measurable processes and outcomes. The primary purpose of the system is to establish a pay-for- performance three year pilot with physicians to encourage the coordination of care, promote investment in administrative structure and process, and reward physicians for improving health care processes and outcomes. 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) assist 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 new 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 Administration on Children, Youth and Families, Child Care Bureau, herein announces an urgent grant award to the South Plains Community Action Association, Inc. (fiscal agent) on behalf of the South Plains Early Childhood Council (Local Council and Grantee), Levelland, Texas, in the amount of $99,999 for a project period of 12 months. This urgent grant award will assist the Local Council in the emergency provision of child care and early learning opportunities to young children and their families who have been evacuated from Mississippi, Louisiana, and other parts of Texas due to Hurricane Katrina. This service area includes 13,575 square miles of the following counties: Bailey, Cochran, Crosby, Dickens, Floyd, Garza, Hale, Hockley, King, Lamb, Lubbock, Lynn, Motley, Terry, and Yoakum. The South Plains Early Childhood Council is well-situated geographically to provide the needed emergency services, and is well- equipped in terms of program activities and cooperating agencies to add immediately and significantly to the child care and related service needs of the evacuee families. The Council is unique in that it serves such a large multi-county rural area that is receiving evacuees and because it has the existing organizational capacity to take the services directly to the rural communities using the FROG bus [Fun Reading on the Go]. This is especially important since the majority of evacuees have no personal form of transportation and public transportation is limited in this rural area. This emergency grant award will provide early learning opportunities, early literacy activities, and mental health support to children under the age of five years, their parents/guardians, caregivers, and child care providers. Young children currently residing in shelters will be given age- and culturally-appropriate books and will receive supplemental supportive educational and social activities from staff trained in early childhood. Young children and their parents/guardians will also be provided with mental health supports by appropriately trained staff to support the children's social and emotional development, and to promote effective parenting.

Pursuant to section 814 of the Native American Programs Act of 1974 (the Act) as amended by 42 U.S.C. 2991b-1, ANA herein describes its proposed interpretive rules, general statement of policy and rules of agency procedure or practice in relation to the Social and Economic Development Strategies (SEDS), Native Language Preservation and Maintenance (hereinafter referred to as Native Language), Environmental Regulatory Enhancement (hereinafter referred to as Environmental) and Environmental Mitigation (hereinafter referred to as Mitigation) programs and any Special Initiatives. Under the statute, ANA is required to provide members of the public an opportunity to comment on proposed changes in interpretive rules, statements of general policy and rules of agency procedure or practice and to give notice of the final adoption of such changes at least thirty (30) days before the changes become effective. The notice also provides additional information about ANA's plan for administering the programs.

This document corrects technical errors in the final rule that appeared in the August 12, 2005 Federal Register entitled ``Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2006 Rates.''

The Food and Drug Administration (FDA) is announcing the following public meeting: Third Annual Stakeholder Meeting on the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). On October 1, 2007, the user fee provisions of MDUFMA will expire. In preparation for discussions regarding legislation to reauthorize and possibly modify MDUFMA user fees, the agency is holding this public meeting to obtain stakeholder input and recommendations on various issues related to this future legislation.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: AFP-L3% Immunological Test Systems.'' This guidance document describes a means by which AFP-L3% (alpha-fetoprotein L3 subfraction percent) immunological test systems may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify AFP-L3% immunological test systems into class II (special controls). This guidance document is immediately in effect as the special control for AFP-L3% immunological test systems, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).

The Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA) is announcing a public hearing on the Center's current risk communication strategies for human drugs. The public hearing announced in this notice is part of the agency's ongoing effort to improve CDER's risk communication. The purpose of the public hearing is to obtain public input on CDER's current risk communication tools, identify stakeholders for collaboration and implementation of additional tools, and obtain greater understanding of the strengths and weaknesses of CDER's existing risk communication.

The Food and Drug Administration (FDA) is announcing that a temporary permit has been issued to Canada's Original ICEBERG Water Corp., to market a product designated as ``Canada's Original Iceberg Water'' that deviates from the U.S. standard of identity for bottled water. The purpose of the temporary permit is to allow the applicant to measure consumer acceptance of the product, identify mass production problems, and assess commercial feasibility.

The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS 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, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``E2B(R) Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance, which revises previous guidance on the same topic, provides standardized data elements for the transmission of individual case safety reports for preapproval and postapproval reporting periods. The revisions in this draft guidance include additional information and clarifications for the electronic transmission of individual case safety reports. The draft guidance is intended to be used with other ICH recommendations for electronic transmissions.

This document corrects typographical and technical errors that appeared in the August 4, 2005 Federal Register, entitled ``Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2006.''

This document corrects technical errors in the final rule that appeared in the August 12, 2005 Federal Register entitled ``Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2006 Rates.''

This document corrects technical errors that appeared in the FY 2006 Inpatient Rehabilitation Facility (IRF) Prospective Payment System (PPS) regulation entitled ``Inpatient Rehabilitation Facility Prospective Payment System for FY 2006'' (70 FR 47880).

This notice announces the selection of a new member 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.

This proposed rule would implement section 1016 of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA) (Pub. L. 108-173) by establishing the loan forgiveness criteria for qualifying hospitals who receive loans under the Health Care Infrastructure Improvement Program.

The Food and Drug Administration (FDA) is amending its regulations concerning the maximum sodium levels permitted for foods that bear the implied nutrient content claim ``healthy.'' The agency is retaining the currently effective, less restrictive, ``first-tier'' sodium level requirements for all food categories, including individual foods (480 milligrams (mg)) and meals and main dishes (600 mg), and is dropping the ``second-tier'' (more restrictive) sodium level requirements for all food categories. Based on the comments received about technological barriers to reducing sodium in processed foods and poor sales of products that meet the second-tier sodium level, the agency has determined that requiring the more restrictive sodium levels would likely inhibit the development of new ``healthy'' food products and risk substantially eliminating existing ``healthy'' products from the marketplace. After reviewing the comments and evaluating the data from various sources, FDA has become convinced that retaining the higher first-tier sodium level requirements for all food products bearing the term ``healthy'' will encourage the manufacture of a greater number of products that are consistent with dietary guidelines for a variety of nutrients. The agency has also revised the regulatory text of the ``healthy'' regulation to clarify the scope and meaning of the regulation and to reformat the nutrient content requirements for ``healthy'' into a more readable set of tables, consistent with the Presidential Memorandum instructing that regulations be written in plain language.

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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on reprocessed single-use device labeling.

This notice announces the first meeting of the American Health Information Community in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.) The American Health Information Community will advise the Secretary and recommend specific actions to achieve a common interoperability framework for health information technology (IT).