Department of Health and Human Services 2006 – Federal Register Recent Federal Regulation Documents

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.

This is notice, in accordance with 35 U.S.C. Sec. 209(c)(1) and 37 CFR Sec. (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 invention embodied in: PCT patent application PCT/US2004/041256 filed December 9, 2004, entitled: ``Methods for Suppressing an Immune Response or Treating a Proliferative Disorder'' [HHS Reference Number: E-259-2003/0-PCT-02], to Sahajanand Medical Technologies Pvt. Ltd., registered as a private limited company in accordance with the Companies Act of India, having a principle place of business in Surat, India and U.S. headquarters in Gaithersburg, Maryland. The field of use may be limited to the use of 2-(4-piperazinyl)-8-phenyl-4H-1-benzopyran-4-one (LY303511), for the treatment and prevention of stenosis and restenois and/or other proliferative disorders. The United States of America is an assignee of the patent rights in these inventions.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institutes of Health (NIH), is giving public notice that the agency proposes to request reinstatement of an information collection activity for which approval has expired. Proposed Collection: Title: NIDDK Information Clearinghouses Customer Satisfaction Survey. Type of Information Requested: Reinstatement, with change, of a previously approved collection for which approval has expired. The OMB control number 0925-0480 expired on July 31, 2003. Need and Use of Information Collection: NIDDK is conducting a survey to access the efficiency and effectiveness of services provided by NIDDK's three clearinghouses: the National Diabetes Information Clearinghouse (NDIC); the National Digestive Diseases Information Clearinghouse (NDDIC); and the National Kidney and Urologic Diseases Information Clearinghouse (NKUDRIC). The survey responds to Executive Order 12821, ``Setting Customer Service Standards,'' which requires agencies and departments to identify and survey their ``customers to determine the kind and quality of service they want and their level of satisfaction with existing services.'' Frequency of Response: On occasion. Affected Public: Individuals or households; business and for profit organizations; not-for-profit agencies, Type of Respondents: Physicians, healthcare professionals, patients, family and friends of patients. The annual reporting burden is as follows: estimated number of respondents: 5,112; estimated number of responses per respondent: 1; estimated average burden hours per response: 0.025; and estimated total annual burden hours requested: 128. The annualized costs to respondents are estimated at $6,400. There are no capital costs to report. There are no operating or maintenance costs to report. Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of the information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

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 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) Detroit 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, November 15, 2006, from 8:30 a.m. to 5 p.m. and Thursday, November 16, 2006, from 8:30 a.m. to 4:30 p.m. Location: The public workshop will be held at the Sheraton Indianapolis Hotel & Suites, 8787 Keystone Crossing, Indianapolis, IN 46240, 317-846-2700, FAX: 317-574-6775. Contact: Nancy Bellamy, Food and Drug Administration, 300 River Pl., suite 5900, Detroit, MI, 48207, 313-393-8143, FAX: 313-393-8139, e-mail: nancy.bellamy@fda.hhs.gov. Registration: Send registration information (including name, title, firm name, address, telephone, and fax number) and the registration fee of $575 (member), $650 (nonmember), or $525 (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, 530 West Butler Ave., suite 109, Chalfont, PA, 18914. To register via the Internet go tohttps:// www.socra.org/html/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 215-822-8644, or via e-mail: socramail@aol.com. Attendees are responsible for their own accommodations. To make reservations at the Sheraton Indianapolis Hotel & Suites, at the reduced conference rate, contact the Sheraton Indianapolis Hotel & Suites (see Location) before October 22, 2006. 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 Nancy Bellamy (see Contact) at least 7 days in advance of the workshop.

The Food and Drug Administration (FDA) will hold a public meeting October 10, 2006, on FDA-regulated products containing nanotechnology materials, and has opened a docket on FDA-regulated products containing nanotechnology materials. The purpose of the meeting will be to help FDA further its understanding of developments in nanotechnology materials that pertain to FDA-regulated products. FDA is interested in learning about the kinds of new nanotechnology material products under development in the areas of foods (including dietary supplements), food and color additives, animal feeds, cosmetics, drugs and biologics, and medical devices, whether there are new or emerging scientific issues that should be brought to FDA's attention, and any other scientific issues about which the regulated industry, academia, and the interested public may wish to inform FDA concerning the use of nanotechnology materials in FDA-regulated products.

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. This notice also announces the release of one Commissioner from service on the Medicaid Commission and the appointment of one new individual to serve on the Medicaid Commission.

The Indian Health Service (IHS), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre- clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) (44 U.S.C. 3506(c)(2)(A)). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. As required by section 3507(a)(1)(D) of the Act, the proposed information collection has been submitted to the Office of Management and Budget (OMB) for review and approval. The IHS received no comments in response to the 60-day Federal Register (71 FR 31195) published on June 1, 2006. The purpose of this notice is to allow an additional 30 days for public comment to be submitted directly to OMB.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Phibro Animal Health. The supplemental NADA provides for the approval of the dihydrate salt of oxytetracycline in their Type A medicated article used in aquaculture feed, a change of oxytetracycline concentration in the Type A medicated article, and the addition of an indication for control of gaffkemia in lobsters.

The Office of Disease Prevention and Health Promotion (ODPHP)/ Office of Public Health and Science (OPHS), announces that up to $250,000 in fiscal year (FY) 2006 funds is available for a cooperative agreement with the Arkansas Center for Health Improvement (ACHI) for a project entitled, ``From BMI to Student Body Mass Improvement: Healthy Achievement Through Awareness and Actiona Detailed Evaluation of the Arkansas School BMI Project.'' Working in collaboration with the ACHI, administratively housed unit in the University of Arkansas for Medical Sciences (501C3 organization) and serves as the primary health policy development source for the Arkansas Department of Health and Human Services, the initiative seeks to gain information about programs that have established school based-body mass index assessments of school age children. The goals of this evaluation project are to identify key elements for the translation of BMI information as a public health intervention for positive behavioral change among families, children and adolescents to improve nutrition and increase physical activity. The project will design and pilot test a detailed evaluation protocol to assess the specific benefits and effectiveness of the Arkansas School BMI Assessment Project, building on the findings from the ACHI ReportThe 2005 Arkansas Assessment of Childhood and Adolescent Obesity; and The Year Two Evaluation of Arkansas Act 1220 conducted by the University of Arkansas for Medical Sciences' College of Public Health with support from The Robert Wood Johnson Foundation. The evaluation protocol will specially address: The effectiveness and acceptability of the BMI assessment by teachers, students, families, and physicians; The essential information and care systems to support follow-up and follow-through for prevention and interventions; The students, families, and schools knowledge, attitudes, and adoption of healthier nutrition and physical activity choices; and, The changes in the individual BMI and the childhood population overweight and obesity rates. The purpose of this project is to assess the principles and outcomes of a statewide community-based intervention program incorporating various scientific methods and behavioral approaches. At a time when overweight and obesity are dramatically increasing, initiatives like the Arkansas School Body Mass Index (BMI) Assessment Project will evaluate the diverse populations that are at higher than average risk of developing excessive weight, especially children in urban/rural areas with a high prevalence of minority individuals. This program promotes several focus areas of the Healthy People 2010 including: Maternal, Infant, and Child Health; Nutrition and Overweight; Physical Activity and Educational and Community-Based Programs Health Communication. The project will be approved for up to a one-year period for a total of $250,000 (including indirect costs). Funding for the cooperative agreement is contingent upon the availability of funds.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria.'' 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 describes a procedure to facilitate acceptance by regulatory authorities of pharmacopoeial test methods (referred to in the draft guidance as analytical procedures and/or acceptance criteria (APAC)) for use in the three ICH regions. The draft guidance is intended to facilitate regulatory acceptance of these proposed test methods and their interchangeability with test methods contained in the local regional pharmacopoeias, thus avoiding redundant testing and different acceptance criteria in favor of a common testing strategy in each ICH regulatory region. Elsewhere in this issue of theFederal Register, FDA is announcing the availability of a draft guidance entitled ``Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria; Annex 1: Residue on Ignition/Sulphated Ash General.''

As required by section 101 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), this final rule creates 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 compensation in the form of items or services (not including cash or cash equivalents) (``nonmonetary remuneration'') that is necessary and used solely to receive and transmit electronic prescription information. In addition, using our separate legal authority under section 1877(b)(4) of the Act, this rule creates a separate regulatory exception for certain arrangements involving the provision of nonmonetary remuneration in the form of electronic health records software or information technology and training services necessary and used predominantly to create, maintain, transmit, or receive electronic health records. These exceptions are consistent with the President's goal of achieving widespread adoption of interoperable electronic health records to improve the quality and efficiency of health care while maintaining the levels of security and privacy that consumers expect.

On May 18, 2006, CDC hosted a public meeting on the subject of infectious disease threats associated with exotic animal importation and trade. CDC announced the public meeting through a Federal Register notice on April 20, 2006 (Volume 71, Number 76, Page 20402-20403). The public meeting was held at 130 Clairemont Ave., Decatur, GA 30030, from 1 p.m. to 5 p.m. Background: Zoonoses are diseases that can be transmitted from animals to people. Wild exotic animals may carry a variety of known and emerging zoonotic pathogens. The American Veterinary Medical Association (AVMA), the Council of State and Territorial Epidemiologists (CSTE), and the National Association of State Public Health Veterinarians (NASPHV) have issued position statements calling for a coordinated federal approach to better control infectious disease risks associated with the exotic animal trade. To gather information on the topic, CDC organized this public meeting to share information concerning infectious disease risks associated with exotic animal importation and trade. Meeting Summary: Five panelists were present to answer potential questions generated by public comments; these panelists represented NASPHV, HHS/CDC, the United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) Animal Care, HHS/ Food and Drug Administration (FDA), and the Department of the Interior (DOI) United States Fish and Wildlife Service (FWS). No questions or comments were posed to the panel during the public meeting. A representative from HHS/CDC's Division of Global Migration and Quarantine provided an overview of the scope of the current issues and problems surrounding exotic animal importation and the spread of disease. Reasons for concern include a high-volume trade with rapid turnover of animals and the absence of health screening for animals prior to or after shipment. The meeting was opened by inviting comments and discussion regarding the exotic pet trade and associated infectious disease risks. The meeting facilitator addressed the time limits for speakers to a maximum of 15 minutes and reminded attendees that the discussion would be a matter of public record. Two registered participants addressed the panel and meeting attendees. A representative of the Consortium for Conservation at Wildlife Trust, New York, read a statement describing the work of the Consortium on exotic animal importation with two primary research objectives: (1) to catalog the wildlife species that are legally imported to the United States each year and assess the risk of this trade introducing pathogens into the United States; and (2) to work with wildlife dealers to understand how the process of importation influences the risk of disease emergence. The Consortium hopes the findings of this scientific initiative will be used to make policy recommendations on disease screening for imported wild animals that will maintain the economic and other benefits of the trade while minimizing risks for introducing new diseases. A representative of PETCO Animal Supplies read a statement indicating that PETCO opposes a possible ban on the importation of exotic animals and fully supports legal importation when proper biosecurity measures are taken to ensure the public health. Details of PETCO's current activities for ensuring animal and owner health and safety were presented. The representative from PETCO also stated that PETCO feels the legal trade of exotic animals has a positive economic effect on captive breeding and export programs in other countries by supporting the local economy and curbing poaching of animals from their native habitats. After the registered participants read their prepared statements, 20 public comments that had been received prior to the meeting by e- mail and fax were read into the public record. Public comments submitted prior to the meeting included the following: Two requests from avian groups (representative of the Indonesian Parrot Project and a representative from the Avian Welfare Coalition) were submitted requesting that importation of all wild birds be banned except for legitimate scientific purposes. In addition, these statements suggested the risk of zoonoses from birds within the United States could be reduced through mandatory quarantine and laboratory testing of birds for interstate transport, enforcing bans on animal fighting, requiring a permit system for commercial sale of birds, and establishing strict biosecurity procedures for avian care facilities. A statement was submitted by a representative from the Captive Wild Animal Protection Coalition requesting a ban of all importation of exotic animals for private ownership, revising legislation to prevent commercial sale of wildlife, forming a single regulatory agency to oversee the exotic animal trade, introducing biosecurity measures to reduce disease risks from wild animals, prohibiting further breeding of wild or exotic animals by private individuals, prohibiting the trade or movement of wild/exotic animals already in private hands, and introducing a new licensing system to ensure that wild/exotic animals held by private individuals are registered. A statement from a private citizen was submitted opposing all exotic animal importation. A statement was submitted from a representative of the Conservator's Center, Inc. opposing actions to prevent organizations that are not members of the Association of Zoos and Aquariums (AZA) from participating in wild/exotic animal ownership. This statement indicated that private sector expertise was needed to facilitate protection of endangered species. This statement requested that any standards imposed on owners or importers be science-based and not influenced by politics or media attention. A statement was submitted from a representative of Big Cat Rescue requesting a prohibition on the trade of exotic cats due to public safety and disease concerns. A statement was submitted from a representative of the Idaho State Department of Agriculture supporting a comprehensive system to restrict importation of any exotic plants and animals, and to allow entry only after appropriate testing and quarantine. A statement was submitted from an owner of a pet monkey stating she believes all pet monkeys in private ownership were born in the United States, and that she does not believe there has been any transfer of disease from pet monkeys to owners in the past 20 years. A statement was submitted from a member of the Society for Small Nonintrusive Government stating that they support a complete ban on exotic animal importation and native wildlife export. This statement indicated an opposition to any federal regulation of exotic animal trade inside the U.S. borders, indicating it is a matter best regulated by individual states. A statement was submitted from a citizen indicating they felt that claims regarding infectious disease risks from exotic animals were over-exaggerated. Five statements were submitted from citizens suggesting that typical domestic pets carry a disease risk similar to that of exotic animals, and that living with pets is beneficial to humans. These statements indicated that exotic animals should be categorized in the same manner as domestic pets, and that proper husbandry and handwashing are common-sense approaches to reduce disease risks. Three statements were submitted from citizens indicating that ferrets are domestic species and should not be restricted. A statement was submitted from a citizen opposing removal of exotic animals from the commercial pet trade and indicating that better regulations, inspections, and oversight would be a more appropriate response. A statement was submitted from a citizen claiming that legislation of the exotic animal trade is best left to individual states, and opposing any more federal legislation on animal importation. In summary, a variety of positions and views were submitted to the public meeting. Of the 22 statements received for consideration, 7 indicated a measure of support for increased restrictions on the importation and sale of exotic species, while 15 expressed support for alternatives to regulatory or legal restrictions or opposition to possible restrictions.

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, to achieve expeditious commercialization of results of federally funded research and development. This opportunity is available until 30 days after publication of this notice. Respondents may be provided a longer period of time to furnish additional information if CDC/NIOSH finds this necessary.

By this document we are informing the public of the Secretary's recognition of certain Certification Commission for Healthcare Information Technology (CCHIT) criteria for ambulatory EHR functionality, interoperability, security and reliability standards. This list of recognized criteria is available by clicking the applicable link at https://www.hhs.gov/healthit. The CCHIT was created in 2004 by an industry coalition of the American Health Information Management Association (AHIMA), the Health Information and Management Systems Society (HIMSS) and the National Alliance for Health Information Technology. CCHIT's mission is to accelerate the adoption of HIT by creating an efficient, credible and sustainable product certification program. During the three comment cycles that generated the ambulatory EHR criteria that the Secretary has recognized, CCHIT received over 1500 comments from a wide range of stakeholders. Further outreach was achieved through the establishment of several large Town Hall presentations with attendances in the range of 500-1000 at Healthcare Information Management Systems Society (HIMSS) conferences as well as at more than thirty smaller presentations to a variety of associations, organizations and the press gatherings. CCHIT grouped its ambulatory EHR certification criteria recommendations into three groups, ``functionality,'' ``interoperability'' and ``security/reliability.'' For ease of understanding, the Secretary broke the security and reliability recommendations into separate categories. Definitions of these categories, and an example that illuminates the various functions of each category are as follows: 1. Functionality criteria identify minimum required and provisional product features for documenting and managing a typical patient encounter. For example, a physician needs to be able to access his/her patient's laboratory test results, so an example of a functional requirement is that an EHR would need to provide the capability of displaying laboratory test results. 2. Interoperability criteria establish standards for how products interact with other products within and across care settings. For example, to ensure interoperability, the physician EHR noted above would need to be able to receive laboratory test results from another physician's (within care settings) as well as from laboratory systems (across care settings). 3. Security and reliability criteria are designed to help the security inspector assess a product's ability to protect, manage and audit access to sensitive patient data. For clarity, we have broken these criteria into the two separate categories, security and reliability. a. Security \1\ addresses the appropriate access to data by appropriate parties and the protection of data from improper manipulation. For example, laboratory test results should be accessible to a treating physician, but inaccessible to a clerical employee who does not need such access to accomplish their job. Security also involves ensuring that data have not been altered or tampered with.

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 Nevada Test Site (NTS), Mercury, Nevada, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On June 26, 2006, 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 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 General Atomics (also known as GA, and/or Division of General Dynamics, and/or John Jay Hopkins Laboratory for Pure and Applied Science), to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: General Atomics. Location: La Jolla, California. Job Titles and/or Job Duties: Potentially worked in the locations: [cir] Building 2 (Science laboratories A, B, and C). [cir] Building 9 (Experimental Building). [cir] Building 10 (Maintenance). [cir] Building 11 (Service Building). [cir] Building 21. [cir] Building 22. [cir] Building 23 (Hot Cell Facility). [cir] Building 25. [cir] Building 26. [cir] Building 27 (Experimental Area Building 1). [cir] Building 27-1 (Experimental Area Building 1). [cir] Building 30 (LINAC Complex). [cir] Building 31 (HTGR-TCF). [cir] Building 33 (Fusion Building). [cir] Building 34 (Fusion Doublet III). [cir] Building 37 (SV-A). [cir] Building 39 (SV-B). [cir] SV-D. Period of Employment: January 1, 1960 through December 31, 1969.

The Food and Drug Administration (FDA) has determined the regulatory review period for EMEND and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA) has determined the regulatory review period for IPLEX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

This notice announces the eighth meeting of the American Health Information Community Chronic Care Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S., App.).

This proposed rule would set forth an update to the 60-day national episode rates and the national per-visit amounts under the Medicare prospective payment system for home health agencies. In addition, this proposed rule would set forth policy changes related to Medicare payment for certain durable medical equipment for the purpose of implementing sections 1834(a)(5) and 1834(a)(7) of the Social Security Act, as amended by section 5101 of the Deficit Reduction Act of 2005. We are also inviting comments on a number of issues including payments based on reporting quality data and health information technology, as well as how to improve data transparency for consumers.

This notice announces those sites for which ATSDR has completed public health assessments during the period from April 2006 through June 2006. This list includes sites that are on or proposed for inclusion on the National Priorities List (NPL) and includes sites for which assessments were prepared in response to requests from the public.

The Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2007 animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Animal Drug User Fee Act of 2003 (ADUFA), authorizes FDA to collect user fees for certain animal drug applications, on certain animal drug products, on certain establishments where such products are made, and on certain sponsors of such animal drug applications and/or investigational animal drug submissions. This notice establishes the fee rates for FY 2007. For FY 2007, the animal drug user fee rates are: $168,600 for an animal drug application; $84,300 for a supplemental animal drug application for which safety or effectiveness data is required; $4,115 for an annual product fee; $51,350 for an annual establishment fee; and $44,850 for an annual sponsor fee. FDA will issue invoices for FY 2007 product, establishment, and sponsor fees by December 30, 2006, and these invoices will be due and payable by January 31, 2007. The application fee rates are effective for applications submitted on or after October 1, 2006, and will remain in effect through September 30, 2007. Applications will not be accepted to review until FDA has received full payment of application fees and any other animal drug user fees owed.

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 reopening until September 15, 2006 the comment period for the proposed rule published in the Federal Register of July 9, 1996 (the 1996 proposed rule) (61 FR 36154). The 1996 proposed rule would revise FDA's infant formula regulations in 21 CFR parts 106 and 107, and FDA is reopening the comment period to receive comment only with respect to specific issues identified in this proposed rule.

The Food and Drug Administration (FDA) is announcing a public meeting it will hold to present work-in-progress on a method for ranking animal feed contaminants by their relative risks to animal and human health. The relative risk posed by feed contaminants to animal and human health consists of two components, namely health consequence scoring and exposure scoring. At this meeting the agency will describe the methods it plans to use to develop animal and human health consequence scoring for chemical, physical, and biological feed contaminants. At one or more subsequent public meetings, FDA will present information about how the health consequence scoring will be combined with information about the exposure of animals and humans to feed contaminants to determine the relative risks of such contaminants in feed. Date and Time: The public meeting will be held on September 12, 2006, from 9 a.m. to 4:30 p.m. Location: The meeting will be held at the Center for Drug Evaluation and Research Conference Room, third floor, 7519 Standish Pl., Rockville, MD 20855.

The National Institutes of Health (NIH) and the Agency for Healthcare Research and Quality (AHRQ) are evaluating guidelines for grant application appendixes in an effort to streamline the application and review processes. This RFI requests input from interested applicants, reviewers and other members of the research community regarding the way appendix materials should be used in the grant submission, review and management process. Comments will be considered in the development of new policies on appendix materials for various grant programs.

The Food and Drug Administration is correcting a notice that appeared in the Federal Register of July 20, 2006. The document announced the availability of a draft document entitled ``Manufactured Food Regulatory Program Standards.'' The document was published with an incorrect Internet address. This document corrects that error.

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 provisions associated with the guidance document entitled ``Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors With Interest in Exporting to Chile.''

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 in the guidance for industry on special protocol assessment.

This notice updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs), for fiscal year (FY) 2007. Annual updates to the PPS rates are required by section 1888(e) of the Social Security Act (the Act), as amended by the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999 (the BBRA), the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (the BIPA), and the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (the MMA), relating to Medicare payments and consolidated billing for SNFs.

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.

Title XXI of the Social Security Act (the Act) authorizes payment of Federal matching funds to States, the District of Columbia, and U.S. Territories and Commonwealths to initiate and expand health insurance coverage to uninsured, low-income children under the State Children's Health Insurance Program (SCHIP). This notice sets forth the final allotments of Federal funding available to each State, the District of Columbia, and each U.S. Territory and Commonwealth for fiscal year 2007. States may implement SCHIP through a separate State program under title XXI of the Act, an expansion of a State Medicaid program under title XIX of the Act, or a combination of both.

The Food and Drug Administration (FDA) is classifying fecal calprotectin immunological test systems into class II (special controls). The special control that will apply to these devices is the guidance document entitled, ``Class II Special Controls Guidance Document: Fecal Calprotectin Immunological Test Systems.'' The agency is classifying these devices into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of these devices. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for these devices.

This notice is to request comments from interested stakeholders in the substance use disorders treatment field regarding SAMHSA's ATTC Program. SAMHSA will be issuing a Request for Applications (RFA) for a new round of competitive cooperative agreement awards under the ATTC program in Federal fiscal year (FFY) 2007. To assist SAMHSA in developing the RFA, SAMHSA is seeking input from stakeholders and interested parties on a number of issues relating to these cooperative agreements. Program Title: Addiction Technology Transfer Centers (ATTC) Program. Catalog of Federal Domestic Assistance (CFDA) Number: 93.243.

The Office of Population Affairs, OPHS, HHS published a notice in the Federal Register of Monday, July 3, 2006 announcing the anticipated availability of funds for family planning services grants. This notice contained an error. The application due date for an eligible State/Population/Area was listed incorrectly. This Notice corrects the application due date for the State of Wisconsin.

The National Institutes of Health (NIH) is amending the current regulations governing its training grants to reflect applicability of the regulations to institutional training grants supporting pediatric research training.

This notice announces the third meeting of the American Health Information Community Biosurveillance Data Steering Group in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Irradiation in the Production, Processing, and Handling of Food'' 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 voluntary nutrition labeling regulations by updating the names and the nutrition labeling values for the 20 most frequently consumed raw fruits, vegetables, and fish in the United States and clarifying guidelines for the voluntary nutrition labeling of these foods. Availability of the updated nutrition labeling values in retail stores and on individually packaged raw fruits, vegetables, and fish will enable consumers to make better purchasing decisions to reflect their dietary needs.

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 provisions of the regulation requiring manufacturers, packers, and distributors of dietary supplements to notify FDA that they are marketing a dietary supplement product that bears on its label or in its labeling a statement provided for in the Federal Food, Drug, and Cosmetic Act (the act).

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.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled, ``Medicare Lifestyle Modification Program (MLMP) Demonstration, System No. 09-70- 0585.'' The program is mandated by the Consolidated Appropriations Act of 2001 (Public Law (Pub. L.) 106-554). The MLMP Demonstration and evaluation will test the feasibility and cost effectiveness of proven and intensive programs designed to reduce or reverse the progression of cardiovascular disease of patients at risk for invasive treatment procedures. The programs may reduce the incidence of hospitalizations and invasive procedures among patients with substantial coronary occlusion. The purpose of this system is to collect and maintain demographic and health related data on the target population of Medicare beneficiaries who are potential participants in the MLMP Demonstration. We will also collect certain identifying information on Medicare providers who provide services to such beneficiaries. Information retrieved from this system may be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, grantee, consultant or other legal agent; (2) assist another Federal or state agency with information to contribute to the accuracy of CMS's proper payment of Medicare benefits, 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 Quality Improvement Organizations; (4) 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; (5) support litigation involving the agency; and (6) combat fraud and abuse in certain Federally-funded 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.

Under the provisions of Section 3507(a) (1) (D) of the Paperwork Reduction Act of 1995, the National Institute on Drug Abuse (NIDA), the National Institutes of Health has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register (on October 27, 2005 Vol. 70, No. 207, p61979), 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.

Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute on Drug Abuse (NIDA), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on March 1, 2006 [Pages 10539-10540] 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 on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: The NIDA International Program Research Training Modules for International Application Needs Assessment Survey. Type of Information Collection Request: NEW. Need and Use of Information Collection: This is a request for a one-time clearance to undertake an educational needs assessment survey of NIDA's collaborating international drug abuse researchers. The purpose of this survey is to more precisely define the educational needs of the international drug abuse research community before proceeding with the development of formal distance learning programs. Reviews of distance education programs in the developing world often reveal that systematically organized learning needs assessments are continually absent. (USAID 2001: The Use and Effect of Distance Education in Healthcare: What Do We Know? Operations Research Issue Paper 2). This survey will address that issue. The survey is based on recommendations received from current international drug abuse researchers and NIDA grantees. It is designed to be brief (2 pages) and succinct, asking respondents to prioritize their educational needs. The questions have been previously tested with persons who speak English as a second language. Total time to complete the survey is less than five minutes. The survey will cover the following elements: (1) Respondent background, including availability of educational technologies, (2) Educational needs, including a ranking of 10 proposed topics in drug abuse education, and (3) Collaborative needs, including an estimate of the value of online tools for research collaboration. The survey will not collect name, address, or other identifying information. Frequency of Response: This project will be conducted once. Affected Public: International drug abuse researchers who are currently affiliated with or wish to be affiliated with the U.S. drug abuse research community. Type of Respondents/Drug Abuse Researchers: physicians, scientists, mental health workers, and scientists-in-training. The reporting burden is as follows: Estimated Total Annual Number of Respondents: 250; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: 0.09. Estimated Total Annual Burden Hours Requested: 22.5. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. The estimated annualized burden is summarized below.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled, ``Medicare Chiropractic Coverage Demonstration and Evaluation (MCCDE), System No. 09-70-0577.'' The demonstration entitled, ``Expansion of Coverage of Chiropractic Services Demonstration'' was established under provisions of Section 651 (d) of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 (Public Law (Pub. L.) 108-173). The MCCDE will focus on selected beneficiaries, residing within the four demonstration regions or their respective control regions, who have Medicare chiropractic-eligible diagnoses [i.e., neuromusculoskeletal conditions (NMS)]. The system will contain: Demographic information from Medicare enrollment files; Medicare claims data on utilization of NMS-related Medicare services with associated costs, for demonstration participants and their matched, non-participant controls; and participant satisfaction survey data for the subset randomly surveyed. The MCCDE has four goals: (1) To determine whether eligible beneficiaries who use chiropractic services under the demonstration use a lesser overall amount of items and services for which payment is made under the Medicare program than eligible beneficiaries who do not use such services; (2) to determine the cost of providing payment for chiropractic services under the Medicare program; (3) to further determine whether the demonstration achieves budget neutrality, and if not, the amount of any cost excess to be recouped by Medicare from the chiropractic profession; and (4) finally, to ascertain the satisfaction of eligible beneficiaries participating in the demonstration projects and their perceived quality of care received. The primary purpose of the system is to collect and maintain individually identifiable information on beneficiaries, physicians, participating chiropractors, and providers of service participating in the demonstration and evaluation program. Information retrieved from this system may be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, consultant or grantee; (2) assist another Federal or state agency with information to contribute to the accuracy of CMS's proper payment of Medicare benefits, 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 litigation involving the agency; and (5) combat fraud and abuse in certain Federally-funded 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.

This notice announces an administrative hearing to be held on August 29, 2006, at the Blanchard Plaza Building, 2201 Sixth Avenue, 11th Floor Conference Room, Seattle, WA 98121, to reconsider CMS' decision to disapprove Alaska State plan amendment 05-06. Closing Date: Requests to participate in the hearing as a party must be received by the presiding officer by August 7, 2006.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute, the National Institutes of Health has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on April 27, 2006 page 26381 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.