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

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.