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

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public.

In this rule, we finalize provisions specified in the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) that establish new data collection, posting, and recordkeeping requirements for skilled nursing facilities (SNFs) and nursing facilities (NFs). It requires that on a daily basis for each shift, SNFs and NFs must post nurse staffing data for the licensed and unlicensed staff directly responsible for resident care in the facility. Facility census information must also be posted. This final rule is also part of a broader communication outreach initiative by CMS to provide beneficiaries, their families, and the public with access to updated data and other information that can assist them in making healthcare decisions.

In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces a meeting of the National Council of Healthcare Research and Quality.

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collection of information, the National Institute on Drug Abuse (NIDA), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: The NIDA Primary Care Physician Outreach Project Type of Information Collection Request: NEW. Need and Use of Information Collection: This is a request for a 4-year generic clearance to study the extent to which NIDA is (1) increasing awareness among primary care physicians and other medical professionals about drug addiction as a major public health issue, (2) increasing their awareness of NIDA and NIDA-funded research, and (3) providing them with the information resources needed to incorporate such research findings into their clinical practices. Primary care physicians and other medical professionals, especially those who care for adolescents, are front line individuals helping patients with drug abuse-or drug addiction-related health and mental health problems. Each has key roles in obtaining, disseminating, and applying drug abuse and addiction resource materials in clinical practice. This effort is made according to Executive Order 12862, which directs Federal agencies that provide significant services directly to the public to survey customers to determine the kind and quality of services they want and their level of satisfaction with existing services. Formative, process, and outcome evaluations using a multi-method approach (surveys, focus, groups, case studies) will be employed to determine the most appropriate resources and also the usefulness of the materials developed for physicians and other medical professionals. Measures will include the following variables: the information needs and learning styles and preferences of physicians and other medical professionals; their knowledge/awareness of NIDA and the NIDA resources developed for physicians and other medical professionals; their attitudes toward NIDA and the NIDA resources developed for them; their use of the resources developed by NIDA; and ways to strengthen NIDA's knowledge dissemination activities. Frequency of Response: This project will be conducted annually or biennially. Affected Public: Individuals, organizations, and businesses. Type of Respondents: physicians, physician assistants, nurses, medical office managers, hospital/clinic based health educators, and hospital/clinic based social workers. The reporting burden is as follows: Estimated Total Annual Number of Respondents: 1118; Estimated Number of Responses per Respondent: 2; Average Burden Hours per Response: 0.39. Estimated Total Annual Burden Hours Requested: 872.24. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. The estimated annualized burden is summarized below.

The Food and Drug Administration (FDA) is announcing the availability of the guidance document entitled ``Class II Special Controls Guidance Document: CFTR Gene Mutation Detection Systems.'' This guidance document describes a means by which cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection systems may comply with the requirements of special controls for class II devices. It includes recommendations for validation of performance characteristics and recommendations for product labeling. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify CFTR gene mutation detection systems into class II (special controls). This guidance document is immediately in effect as the special control for CFTR gene mutation detection systems, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Potassium Chloride Modified-Release Tablets and Capsules: In Vivo Bioequivalence and In Vitro Dissolution Testing.'' This guidance document provides recommendations to sponsors of abbreviated new drug applications (ANDAs) on the design of bioequivalence studies for modified-release dosage forms of potassium chloride.

The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), Section 104(i)(3) [42 U.S.C. 9604(i)(3)] directs the Administrator of ATSDR to prepare toxicological profiles of priority hazardous substances and to revise and publish each updated toxicological profile as necessary. This notice announces the availability of the 19th set of toxicological profiles, which consists of one new draft and seven updated drafts, prepared by ATSDR for review and comment.

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 the use of rapid response surveys to obtain data on safety information to support quick- turnaround decisionmaking about potential safety problems or risk management solutions from health care professionals, hospitals and other user-facilities (e.g., nursing homes, etc.); consumers; manufacturers of biologics, drugs, and medical devices; distributors; and importers when FDA must quickly determine whether or not a problem with a biologic, drug, or medical device impacts the public health.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``2005 Food Safety Survey'' 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 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 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 the information collection contained in the guidance for industry on formal meetings with sponsors and applicants for Prescription Drug User Fee Act (PDUFA) products.

The purpose of this notice is to announce that the National Institutes of Health (NIH) will hold a Town Hall meeting to hear comments and insights concerning possible revisions to certain fiscal policies that govern the Ruth L. Kirschstein National Research Service Awards (NRSA), which comprise institutional training grants (T32 and T34s) and individual fellowships (F30, F31, F32, F33). The meeting which is open to the public will focus primarily on the funding of educational costs such as tuition, fees and health insurance provided through institutional training grants. The meeting will be held November 30, 2005 in the Natcher Conference Center, Room E1/E2 on the NIH campus in Bethesda, Maryland. Background: NRSA programs currently support over 17,000 predoctoral and postdoctoral research training positions mostly in the nation's academic laboratories. While the budget for the NRSA programs grew smartly during the five years in which the overall appropriation for the NIH was doubled, since fiscal 2003, the last of the growth years, the appropriation for NRSA training programs has grown rather modestly. Given this reality, the NIH must re-examine aspects of its NRSA policies that may not be sustainable in a period of limited budget expansion. The largest of the NRSA programs funds institutional training grants that use the T32 mechanism to support both pre- and post- doctoral research training. Currently, the direct cost funding of these programs is segmented into four categories: stipend, tuition/fees/ health insurance (referred to collectively as tuition), travel, and training related expenses. The funding levels for three of these (stipend, travel, and training related expenses) are stipulated and controlled by NIH, although each can be adjusted as fiscal circumstances and program needs evolve. The funding for tuition, on the other hand, is not fully controlled by NIH; the funding for tuition is governed by a formula tied to the amount each institution requests for this expense. The formula provides for each T32 trainee the sum of $3,000 plus sixty percent of the requested tuition in excess of $3,000. This formula is used to determine the tuition level provided via each competing grant; that level, once established for a given competing grant, is used for the subsequent non-competing renewal awards during the project period. This formula has been employed since fiscal 1996 and has been modified once. During the five year growth period, the increased funding devoted to NRSA activities was used for meaningful, and long overdue, trainee stipend increases and for covering some of the escalating requests in the tuition category of training grants. However, in fiscal 2004 and 2005, when there was limited NRSA budget growth, the requests and outlays for tuition continued to rise substantially. Barring other adjustments, the continuation of this trend in tuition growth will result in a significant annual decrease in the number of NRSA trainee positions, and to fewer programs supported by T32 training grants. Since these outcomes could have a substantial disruptive effect on biomedical research training, NIH has frozen the tuition expenses on competing renewals of T32 awards in fiscal 2006. (See https:// grants.nih.gov/grants/guide/notice-files/NOT-OD-05-059.html) Moreover, NIH training officials have decided to study various options for handling the funding of trainee tuition in the future. The goal of this effort is to find an approach that equips the agency both to adjust to budgetary challenges and to continue to provide appropriate support to institutions to help defray the educational costs of NRSA trainees. This town hall meeting is being held to gather the views of the training community on this issue. Among the options that will be studied are the following: 1. The current tuition formula could be applied in conjunction with a ceiling; the funds provided would be the amount dictated by the currently-used formula or the amount dictated by the ceiling, whichever is less. The magnitude of the ceiling would be based on the fiscal resources available as well as on applicable data. For the sake of discussion, those offering comments may assume the ceiling could be in the range of $16,000 to $18,000. 2. A fixed allowance could be provided for tuition; the same allowance per trainee would be provided to each grantee institution. This approach is employed by the National Science Foundation for its graduate research fellowship program. For the sake of discussion, those offering comments may assume the allowance could be in the range of $16,000 to $18,000. The allowance could be adjusted periodically by the NIH as fiscal circumstances warranted. 3. The current tuition formula could be retained without modification. Those offering comments may assume that under this option the number of NRSA trainees and funded training grant programs will likely experience a series of year-to-year decreases as long as the current fiscal patterns prevail. Participation: Those who wish to attend the Town Hall meeting are invited to submit a brief statement, not to exceed two pages, summarizing views and experiences relevant to the topic of the meeting. Some of those submitting statements will be asked to make brief oral presentations at the meeting. In selecting those to make presentations and in allocating time, the organizers hope to ensure that a full range of opinions is heard and that all parts of the NRSA constituency are represented. Those not asked to present will be welcome at the meeting and will be given a brief opportunity to contribute during two ``open mike'' sessions. Individuals should submit their statements along with their name, affiliation, and contact information to NRSATownHall@mail.nih.gov by November 4, 2005. Individuals chosen to make presentations at the Town Hall meeting will be notified on or around November 14, 2005. Those unable to attend but who wish to provide statements are welcome to do so. All statements will be considered by NIH staff. Those who do not submit statements but wish to observe the meeting will be admitted on a space-available basis. An NIH official will present background information on NRSA tuition support at the outset of the meeting. All individuals who wish to attend the meeting should register through the Town Hall meeting's Web site at https://pub.nigms.nih.gov/ nrsameeting, available on or about October 24, 2005. The detailed schedule for the meeting, when completed, will be posted on this Web site along with any meeting updates. Participants are responsible for their own expenses associated with participating in this meeting, such as for travel. Inquiries: Questions concerning this notice should be directed to: Dr. Warren Jones, National Institute of General Medical Sciences, National Institutes of Health, 301-594-3827, jonesw@nigms.nih.gov.

The NTP has developed and refined a vision for toxicology in the 21st century (``NTP Vision'') and a roadmap for implementing its vision (``NTP Roadmap'') to strategically place the program at the forefront of providing scientific data and its interpretation for use in public health decision-making (see NTP Web site https:// ntp.niehs.nih.gov select ``NTP Vision and Roadmap''). As part of the NTP Roadmap, the NTP will convene a series of workshops, including the High Throughput Screening Assays Workshop, to discuss test methods and approaches that will enhance the program's ability to efficiently evaluate the large number of substances in our environment for which there is little or no information about their potential hazard for human health. This workshop is scheduled for December 14-15, 2005, at the Hyatt Regency Crystal City, 2799 Jefferson Davis Highway, Arlington, VA and will focus on providing information about high throughput screening techniques and the potential utility of this technology for toxicology and the NTP. This meeting is open to the public and attendance is limited only by the space available. Individuals may register to attend the workshop on a first-come, first- served basis per the procedures outlined below. A copy of the agenda and any additional information about the workshop, including background materials and participants, will be posted on the NTP Web site when available (see NTP Web site https://ntp.niehs.nih.gov select ``Meetings and Workshops'').

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 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.