Department of Health and Human Services 2006 – Federal Register Recent Federal Regulation Documents
Results 1,601 - 1,800 of 3,314
Recruitment of Sites for Assignment of Corps Personnel
The Health Resources and Services Administration (HRSA) announces that the listing of entities, and their Health Professional Shortage Area (HPSA) scores, that will receive priority for the assignment of National Health Service Corps (NHSC) personnel (Corps Personnel, Corps members) for the period July 1, 2006 through June 30, 2007 is posted on the NHSC Web site at https://nhsc.bhpr.hrsa.gov/ resources/fedreg-hpol/. This list specifies which entities are eligible to receive assignment of Corps members who are participating in the NHSC Scholarship Program, the NHSC Loan Repayment Program, and Corps members who have become Corps members other than pursuant to contractual obligations under the Scholarship or Loan Repayment Programs. Please note that not all vacancies associated with sites on this list will be for Corps members, but could be for individuals serving an obligation to the NHSC through the Private Practice Option.
Decision To Evaluate a Petition To Designate a Class of Employees at the S-50 Oak Ridge Thermal Diffusion Plant, Oak Ridge, TN, To Be Included in the Special Exposure Cohort
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 S-50 Oak Ridge Thermal Diffusion Plant, Oak Ridge, Tennessee, 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: S-50 Oak Ridge Thermal Diffusion Plant. Location: Oak Ridge, Tennessee. Job Titles and/or Job Duties: All workers. Period of Employment: 1944 through 1951.
Decision To Evaluate a Petition To Designate a Class of Employees at the Los Alamos National Laboratory, Los Alamos, NM, To Be Included in the Special Exposure Cohort
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 Los Alamos National Laboratory, Los Alamos, New Mexico, 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: Los Alamos National Laboratory. Location: Los Alamos, New Mexico. Job Titles and/or Job Duties: All workers potentially exposed to radioactive lanthanum at the Technical Area 10 Bayo Canyon facility, TA-35 (Ten Site), or TA-1, buildings Sigma, H, and U. Period of Employment: September 1, 1944 through July 18, 1963.
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 015
The Food and Drug Administration (FDA) is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 015'' (Recognition List Number: 015), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Medicare and Medicaid Programs; Denial of the TÜV Healthcare Specialists Request for Deeming Authority for Hospitals
This final notice announces our decision to deny T[Uuml]V Healthcare Specialists' (T[Uuml]VHS) request for deeming authority for hospitals that wish to participate in the Medicare and Medicaid programs.
Medicare Program; Second Biannual Meeting of the Advisory Panel on Ambulatory Payment Classification (APC) Groups-August 23, 24, and 25, 2006
In accordance with section 10(a) of the Federal Advisory Committee Act (FACA) (5 U.S.C. Appendix 2), this notice announces the second biannual meeting of the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel) for 2006. The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary of Health and Human Services (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) concerning the clinical integrity of the APC groups and their associated weights. The advice provided by the Panel will be considered as we prepare the final rule that updates the hospital Outpatient Prospective Payment System (OPPS) for CY 2007.
Medicare Program; Identification of Backward Compatible Version of Adopted Standard for E-Prescribing and the Medicare Prescription Drug Program (Version 8.1)
This interim final rule with comment period identifies the Prescriber/Pharmacist Interface SCRIPT Standard, Implementation Guide, Version 8.1 (hereafter referred to as ``Version 8.1 of the National Council for Prescription Drug Programs (NCPDP) SCRIPT Standard'') as a backward compatible update of the adopted Version 5.0. This interim final rule with comment period also permits the voluntary use of Version 8.1 of the NCPDP SCRIPT Standard for conducting certain e- prescribing transactions for the electronic prescription drug program under Title I of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA).
Medicare Program; Meeting of the Medicare Coverage Advisory Committee-August 30, 2006
This notice announces a public meeting of the Medicare Coverage Advisory Committee (MCAC) (``Committee''). Among other things, the Committee provides advice and recommendations about whether scientific evidence is adequate to determine whether certain medical items and services are reasonable and necessary under the Medicare statute. This meeting will discuss the following issues: (1) Glycemic control and the use of glucose monitors by which sensors automatically monitor glucose levels in body fluids; and (2) whether and how the frequency of outpatient glucose monitoring is related to glycemic control and clinical outcomes in the various Medicare populations. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-January Through March 2006
This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January 2006 through March 2006, relating to the Medicare and Medicaid programs. This notice provides information on national coverage determinations (NCDs) affecting specific medical and health care services under Medicare. Additionally, this notice identifies certain devices with investigational device exemption (IDE) numbers approved by the Food and Drug Administration (FDA) that potentially may be covered under Medicare. This notice also includes listings of all approval numbers from the Office of Management and Budget for collections of information in CMS regulations. Finally, this notice includes a list of Medicare-approved carotid stent facilities. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, and to foster more open and transparent collaboration efforts, we are also including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this 3-month time frame.
Agency Information Collection Activities; Proposed Collection; Comment Request; Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications
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 procedure by which an applicant may obtain an assignment or designation determination.
Determination of Regulatory Review Period for Purposes of Patent Extension; CIALIS
The Food and Drug Administration (FDA) has determined the regulatory review period for CIALIS 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 that claims that human drug product.
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management.
Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Laxative Ingredient
The Food and Drug Administration (FDA) is announcing a call- for-data for safety and effectiveness information on the following condition as part of FDA's ongoing review of over-the-counter (OTC) drug products: Sodium picosulfate, up to 10 milligrams (mg), as a laxative single active ingredient. FDA reviewed a time and extent application (TEA) for this condition and determined that it is eligible for consideration in our OTC drug monograph system. FDA will evaluate the submitted data and information to determine whether this condition can be generally recognized as safe and effective (GRAS/E) for its proposed OTC use.
Meeting of the Chronic Fatigue Syndrome Advisory Committee
As stipulated in the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will hold a meeting. The meeting is open to the public.
Solicitation of Nomination for Appointment to the Chronic Fatigue Syndrome Advisory Committee
The Office of Public Health and Science, HHS, is seeking nominations of qualified candidates to be considered for appointment as a member of the Chronic Fatigue Syndrome Advisory Committee (CFSAC). CFSAC provides science-based advice and recommendations to the Secretary of Health and Human Services, through the Assistant Secretary for Health, on a broad range of issues and topics pertaining to chronic fatigue syndrome (CFS). CFSAC, which was formerly known as the Chronic Fatigue Syndrome Coordinating Committee, was established by the Secretary of Health and Human Services on September 5, 2002. The appointments of five Committee members are scheduled to end on September 30, 2006. Nominations of qualified candidates are being sought to fill these scheduled vacancies.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Substances Generally Recognized as Safe: Notification Procedure
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Substances Generally Recognized as Safe: Notification Procedure'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Recommendations for Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Recommendations for Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Requesting an Extension to Use Existing Label Stock After the Trans Fat Labeling Effective Date of January 1, 2006
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Requesting an Extension to Use Existing Label Stock After the Trans Fat Labeling Effective Date of January 1, 2006,'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Determination of Regulatory Review Period for Purposes of Patent Extension; BONIVA
The Food and Drug Administration (FDA) has determined the regulatory review period for BONIVA 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 that claims that human drug product.
Agency Information Collection Activities; Proposed Collection; Comment Request; Infectious Disease Issues in Xenotransplantation
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 collection of information contained in the Public Health Service (PHS) guideline entitled ``PHS Guideline on Infectious Disease Issues in Xenotransplantation'' dated January 19, 2001.
Government-Owned Inventions; Availability 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.
Request for Public Comment: 60-Day Proposed Information Collection: Indian Health Service Medical Staff Credentials and Privileges Files
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 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. Currently, the IHS is providing a 60-day advance opportunity for public comment on a proposed new collection of information to be submitted to the Office of Management and Budget for review.
Guidance for Industry; Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use; Availability
The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry entitled ``Recommendations for the Early Food Safety Evaluation of New Non- Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use.'' The guidance provides recommendations to developers of new plant varieties, including bioengineered plant varieties, on the early food safety evaluation of new non-pesticidal proteins. The guidance describes procedures for submitting an early food safety evaluation of such proteins to the agency.
The Essentials of Food and Drug Administration Device Regulations: A Primer for Manufacturers and Suppliers; Public Workshop
The Food and Drug Administration (FDA) San Francisco District, in cooperation with AdvaMed's Medical Technology Learning Institute, is announcing a public workshop on FDA device regulations. This 2-day public workshop for start up and small device manufacturers and their suppliers will include both industry and FDA perspectives and a question and answer period. Date and Time: The public workshop will be held on July 12, 2006, from 8:30 a.m. to 5:30 p.m. and July 13, 2006, from 8:30 a.m. to 5 p.m. Location: The public workshop will be held at The Marriott Fremont, 46100 Landing Pkwy., Fremont, CA 94538, 510-413-3710, FAX: 510-413- 3710. For further hotel information and driving directions, go to https://Marriott.com/property/propertypage/sjcfm. (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.) Contact: For FDA: Eric Anderson, Office of Regulatory Affairs (HFR- PA1530), Food and Drug Administration, 96 North Third St., San Jose, CA 95115, 408-291-7548, ext. 115, FAX: 408-291-7228, e-mail: eric.anderson@fda.hhs.gov. For AdvaMed: Krystine McGrath, 202-434-7237, FAX: 202-434-7850, e- mail: kmcgrath@advamed.org. Registration: Send registration information (including name, title, firm name, address, telephone, and fax number) and the registration fee of $495.00 per person to the AdvaMed contacts (see Contact). The registration fee for FDA employees is waived. To register via the Internet go to https://www.advamedmtli.org/mtli/fda.cfm. (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.) Payment forms accepted are major credit cards (MasterCard, Visa, or American Express) or company check. If you wish to pay by check, contact Krystine McGrath (see Contact). For more information on the meeting, or for questions on registration, contact Krystine McGrath (see Contact). Attendees are responsible for their own accommodations. The registration fee will be used to offset the expenses of hosting the workshop, including meals (breakfasts and lunches), refreshments, meeting rooms, and training materials. It also includes a networking reception on July 12, 2006. Space is limited; therefore, interested parties are encouraged to register early. There will be no onsite registration. If you need special accommodations due to a disability, please contact Eric Anderson (see Contact) at least 7 days in advance of the workshop.
Draft Guidance for Industry and Food and Drug Administration Staff; the Review and Inspection of Premarket Approval Applications Under the Bioresearch Monitoring Program; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program.'' One of the performance goals, referenced in a letter to Congress from the Secretary of Health and Human Services that accompanied the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) legislation, includes a commitment to improve FDA's scheduling and timeliness of preapproval inspections. This draft guidance document is intended to assist applicants in understanding the process involved in the bioresearch monitoring (BIMO) review of the clinical and nonclinical information in their premarket approval application (PMA) and the process involved in any related inspections. Premarket notification (510(k)) submissions are not addressed in this draft guidance because a premarket inspection is not ordinarily conducted for 510(k)s. This draft guidance is not final nor is it in effect at this time.
Amendment of February 4, 2004, Order to Embargo Birds and Bird Products Imported From Djibouti
On February 4, 2004, the Centers for Disease Control and Prevention (CDC) within the U.S. Department of Health and Human Services issued an order to ban immediately the import of all birds (Class: Aves) from specified countries, subject to limited exemptions for returning pet birds of U.S. origin and certain processed bird- derived products. HHS/CDC took this step because birds from these countries potentially can infect humans with avian influenza (influenza A/[H5N1]). The February 4, 2004, order complemented a similar action taken at the same time by the Animal and Plant Health Inspection Service (APHIS) within the U.S. Department of Agriculture (USDA). On March 10, 2004, HHS/CDC lifted the embargo of birds and bird products from the Hong Kong Special Administrative Region (HKSAR) because of the documented public-health and animal health measures taken by Hong Kong officials to prevent spread of the outbreak within the HKSAR, and the absence of highly pathogenic avian influenza H5N1 cases in Hong Kong's domestic and wild bird populations. USDA/APHIS took a similar action. On September 28, 2004, HHS/CDC extended the embargo on birds and bird products to include Malaysia because of the documented cases of highly pathogenic avian influenza A H5N1 in poultry in Malaysia. On July 20, 2005, USDA/APHIS adopted as a final rule the interim rule that became effective on February 4, 2004, which amended its regulations to prohibit or restrict the importation of birds, poultry, and unprocessed birds and poultry products from regions that have reported the presence of highly pathogenic avian influenza H5N1 in poultry. (See 70 FR 41608 [July 20, 2005].) As the United Nations Food and Agriculture Organization and the World Organization for Animal Health (OlE) have confirmed additional cases of highly pathogenic avian influenza (H5N1), USDA/APHIS has added additional countries to its ban. Because of the documentation of highly pathogenic avian influenza H5N1 in poultry, HHS/CDC added the following countries to its embargo: Kazakhstan, Romania, Russia, Turkey, and Ukraine on December 29, 2005; Nigeria on February 8, 2006; India on February 22, 2006; Egypt on February 27, 2006; Niger on March 2, 2006; Albania, Azerbaijan, Cameroon, and Burma (Myanmar) on March 15, 2006; Israel on March 20, 2006; Afghanistan on March 21, 2006; Jordan on March 29, 2006; Burkina Faso on April 10, 2006; Pakistan on April 10, 2006; Gaza, the West Bank, and the Ivory Coast (C[ocirc]te d'Ivoire) on April 28, 2006; and Sudan on May 16, 2006. On May 27, 2006, OlE reported confirmation of highly pathogenic avian influenza H5N1 in poultry in Djibouti. At this time, HHS/CDC is adding Djibouti to its current embargo. USDA has also taken a similar action with respect to this region. This action is effective on June 2, 2006, and will remain in effect until further notice.
Announcement of Availability of Funds for the National Faith-Based and National Community Cardiovascular Disease Prevention Programs for High-Risk Women
The Office on Women's Health, Office of Public Health and Science, Office of the Secretary, published a notice in the Federal Register on Tuesday, June 6, 2006 announcing the availability of funds for approximately two grants. This notice is to correct the following information contained in that announcement: (1) Corrects the Anticipated Award date for the grant awards. (2) Amends the expected increase of funding available for this grant; thereby, increasing the number of grants to be awarded, and also increasing the funding amount for each individual grant award. (3) Corrects the number of pages to be submitted for the Project Narrative description to be submitted in the grant application. (4) Corrects the omission of the Office on Minority Health as a partner during the performance period of this grant. (5) Corrects some statistical data provided in the announcement. (6) Corrects some page numbers listed in the Reference section in the announcement.
Request for Applications for the Targeting Obesity in Young Women to Prevent the Development of Type II Diabetes Program
The Office on Women's Health (OWH) is the focal point for women's health within the Department of Health and Human Services (DHHS). Under the direction of the Deputy Assistant Secretary for Women's Health, OWH provides leadership to promote the health equity for women and girls through gender-specific approaches. To that end, OWH has established public/private partnerships to address critical women's health issues nationwide. These include supporting collaborative efforts to provide accurate prevention education and programs for young women at risk for developing type II diabetes because they are overweight or obese. These awards focus on the HHS initiative Emphasize Healthy Living and Prevention of Disease, Illness, and Disability in the ``One Department. One Direction'' Department-wide Objectives. This program is authorized by 42 U.S.C. 300u-2(a).
Proposed Collection; Comment Request; Aggression Prevention Among High-Risk Early Adolescents
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Child Health and Human Development (NICHD), 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.
Submission for OMB review; Comment Request; Environmental Factors in the Development of Polycystic Ovary Syndrome
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Environmental Health Sciences (NIEHS), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on January 20, 2006, pages 3310-3311 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: Environmental Factors in the Development of Polycystic Ovary Syndrome. Type of Information Collection Request: Revision of OMB No. 0925- 0483 and expiration date 3/31/2006. Need and Use of Information Collection: The purpose of this study is to identify a cohort of living female twin pairs in which at least one member is likely to have Polycystic Ovary Syndrome (PCOS) for future study. Potential participants (-2,200) will come from the Mid- Atlantic Twin Registry (MATR) and were chosen based on their answers to several questions (in a preliminary MATR survey) concerning irregular periods and a history of polycystic cystic ovaries. The instrument to be used here will be administered by telephone by professional interviewers at the MATR. It contains 17 simple and direct questions and will take about 10 minutes to complete. It contents deal with the frequency of menstrual periods, a history of polycystic ovaries, obesity, excess facial hair and other evidence of hyperandrogenism. Since this is such a short telephone survey, participants will receive no prior notification. Informed consent will be asked for verbally over the phone at the time of the interview. A; participants will be asked about their willingness to participate in future studies if their answers meet certain criteria. The major objectives of future studies using this cohort are to determine more reliable concordance rates for PCOS in monozygotic and diygotic twins, establish baseline heritability estimates, and develop hypotheses concerning possible pathogenetic and/ or environmental factors. The findings from this study will aid in developing: (1) Genetic tests to identify high risk women; (2) preventative strategies; and (3) more effective therapies for PCOS and related syndromes such as type 2 diabetes, obesity, idiopathic hyperandrogenism, and male pattern baldness. Frequency of Response: One time. Affected Public: Individuals or households. Type of Respondents: Adult women. The annual reporting burden is as follows: Estimated Number of Respondents: 2,200; Estimated Number of Responses Per Respondent: 1; Average Burden Hours Per Response: 0.167; and Estimated Total Annual Burden Hours Requested: 122 per year for 3 more years. The annualized costs to respondents is estimated at $2,050.38. 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 fuction 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 information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technology collection techniques or other forms of information technology. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, New Executive Office Building, Room 10235, Washington, DC 20503, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Dr. Patricia C. Chulada, Clinical Research Scientist, Clinical Research Office, NIEHS, P.O. Box 12233, Research Triangle Park, NC 27709 or call non-toll-free number (919) 541-7736 or e-mail your request, including your address to: chulada@niehs.nih.gov. Comments Due Date: Comments regarding this infomation collection are best assured of having their full effect if received within 30-days of the date of this publication.
Determination of Regulatory Review Period for Purposes of Patent Extension; ROZEREM
The Food and Drug Administration (FDA) has determined the regulatory review period for ROZEREM 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.
Guidance for Industry and Food and Drug Administration Staff; the Review and Inspection of Premarket Approval Application Manufacturing Information and Operations; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations.'' One of the performance goals, referenced in a letter that accompanied the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) legislation, includes a commitment to improve FDA's scheduling and timeliness of preapproval inspections. This draft guidance document is intended to assist manufacturers in preparing for FDA's review of their premarket approval application (PMA) manufacturing section and in the coordination of the preapproval inspection of the manufacturing operations described in the PMA or PMA supplement. This draft guidance document does not address premarket notification (510(k)) submissions because a premarket inspection is not ordinarily conducted for 510(k) submissions. This draft guidance is not final nor is it in effect at this time.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Extension With Change of the Expiration Date of the Title VI Program Performance Report
The Administration on Aging (AoA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
2005 White House Conference on Aging
Pursuant to Section 10(a) of the Federal Advisory Committee Act as amended (5 U.S.C. Appendix 2), notice is hereby given that the Policy Committee of the 2005 White House Conference on Aging will discuss items related to the final report of the Conference during a conference call. The conference call will be open to the public to listen, with call-ins limited to the number of telephone lines available. Individuals who plan to call in and need special assistance, such as TTY, should inform the contact person listed below in advance of the conference call. This notice is being published less than 15 days prior to the conference call due to scheduling problems.
Merck & Co., Inc., et al.; Withdrawal of Approval of 65 New Drug Applications and 52 Abbreviated New Drug Applications
The Food and Drug Administration (FDA) is withdrawing approval of 65 new drug applications (NDAs) and 52 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Determination of Regulatory Review Period for Purposes of Patent Extension; SYMLIN
The Food and Drug Administration (FDA) has determined the regulatory review period for SYMLIN 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; INSPRA
The Food and Drug Administration (FDA) has determined the regulatory review period for INSPRA 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 that claims that human drug product.
Response to Solicitation on Organ Procurement and Transplantation Network (OPTN) Living Donor Guidelines
A notice was published in the Federal Register on January 23, 2006 (Vol. 71, No. 14, pages 3519-3520). The purpose of this notice was to solicit comments to assist HRSA in determining whether criteria developed by the Organ Procurement and Transplantation Network (OPTN) concerning organs procured from living donors, including those concerning the allocation of organs from living donors, should be given the same status, and be subject to the same enforcement actions, as other OPTN policies.
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Final Guidance for Industry on “Specifications: Test Procedures and Acceptance Criteria for New Veterinary Drug Substances and New Medicinal Products: Chemical Substances;” Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance document for industry (176) entitled ``Specifications: Test Procedures and Acceptance Criteria for New Veterinary Drug Substances and New Medicinal Products: Chemical Substances'' (VICH GL-39). This guidance has been developed for veterinary use by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is intended to assist to the extent possible, in the establishment of a single set of recommended global specifications for new veterinary drug substances and medicinal products. It provides guidance through recommendations on the setting and justification of acceptance criteria and the selection of test procedures for new veterinary drug substances of synthetic chemical origin, and new medicinal products produced from them, which have not been registered previously in the United States, the European Union, or Japan.
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Final Guidance for Industry on “Specifications: Test Procedures and Acceptance Criteria for New Biotechnological/Biological Veterinary Medicinal Products;” Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance document for industry (177) entitled ``Specifications: Test Procedures and Acceptance Criteria for New Biotechnological/Biological Veterinary Medicinal Products'' (VICH GL40). This guidance has been developed for veterinary use by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document provides general principles through recommendations on the setting and justification, to the extent possible, of a uniform set of international specifications for biotechnological and biological products to support new marketing applications.
New Animal Drugs for Use in Animal Feeds; Lasalocid; Correction
The Food and Drug Administration (FDA) is correcting a document amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) that appeared in the Federal Register of April 27, 2006 (71 FR 24814). FDA is correcting a paragraph designation in the table for lasalocid cattle feeds which was drafted in error. This correction is being made to improve the accuracy of the animal drug regulations.
Georgia-Pacific Resins, Inc.; Filing of Food Additive Petition
The Food and Drug Administration (FDA) is announcing that Georgia-Pacific Resins, Inc., has filed a petition proposing that the food additive regulations be amended to provide for the safe use of glycerol ester of tall oil rosin to adjust the density of citrus oils used in the preparation of beverages and to provide for the use of steam stripping as a purification method for producing glycerol ester of wood rosin, gum rosin, or tall oil rosin.
Agency Recordkeeping/Reporting Requirement Under Emergency Review by the Office of Management and Budget (OMB); Retraction
The Administration for Children and Families published a notice in the Federal Register on June 6, 2006, requesting comments on reporting requirements contained in the Interim Final Rule for the Reauthorization of the Temporary Assistance for Needy Families Program. As the subject rule has not yet been published, the Administration for Children and Families is retracting the notice.
Privacy Act System of Records-Medical Staff Credentials and Privileges Records
Pursuant to the provisions of the Privacy Act of 1974, as amended, 5 U.S.C. 552a(e)(4), the IHS has amended and is publishing the proposed alteration of a system of records, System No. 09-17-0003, ``Medical Staff Credentials and Privileges Records.'' The amended and altered system of records makes only one administrative revision as necessary.
Mississippi Institute for Improvement of Geographic Minority Health and Health Disparities Program
This announcement is made by the United States Department of Health and Human Services (HHS or Department), Office of Minority Health (OMH) located within the Office of Public Health and Science (OPHS), and working in a ``One-Department'' approach collaboratively with participating HHS agencies and programs (entities). The mission of the OMH is to improve the health of racial and ethnic minority populations through the development of policies and programs that address disparities and gaps. OMH serves as the focal point in the HHS for leadership, policy development and coordination, service demonstrations, information exchange, coalition and partnership building, and related efforts to address the health needs of racial and ethnic minorities. This announcement supports the Healthy People 2010 overarching goal to eliminate health disparities. As part of a continuing HHS effort to improve the health and well being of racial and ethnic minorities, the Department announces availability of FY 2006 funding for the Mississippi Institute for Improvement of Geographic Minority Health and Health Disparities Program. Despite significant improvements in the overall health status of the nation over the past decades, disparities in health status continue to persist among racial and ethnic minority and disadvantaged populations. Such disparities are clearly illustrated by health status statistics in southern areas of the United States. Mississippi serves as an important pilot location for the development of a geographic and minority health disparities model for the nation. Mississippi has a population of 2.8 million, 37 percent of whom are African American, and 51percent of whom live in rural areas. It is the fourth most rural state in the nation, and is ranked 31st in terms of population size. The significant disease burden of the state is well documented. It ranks first of all states and the District of Columbia in mortality rates due to cardiovascular disease (30 percent higher than the national average). In 1996, the cardiovascular disease-related death rate for African Americans in the state was 37 percent greater than for whites, and 60 percent greater than the overall national rate. Stroke mortality, the third leading cause of death in Mississippi, is 18 percent higher than the rate for the U.S. as a whole. It has the highest prevalence of diabetes and obesity in the nation; approximately 9 percent of the state's adult population are diabetic and 55 percent are obese. Mississippi ranks 5th highest overall in cancer mortality rates among the 50 states and the District of Columbia. African Americans make up more than 75 percent of the state's reported new AIDS cases. Premature death rates are almost 2 times greater for American Indians and 1.5 times greater for African Americans than whites. The infant mortality rate in a number of counties along the Mississippi Delta is three times that of the national average. Mississippi has many challenges affecting access to medical care. Almost one-quarter of the state's population, aged 18 to 64, report having no health insurance; higher than the 15.7 percent of people nationally without health insurance in 2004, according to the U.S. Census. Other reasons for insufficient access include the state's ratio of medical doctors to its general population, which is about half the national average, and the large percentage of rural, sparsely-populated areas within the state. Access to health care and delivery of services to a sizeable population in Mississippi, already inadequate, have been further impacted by the devastation caused by last year's hurricanes. The Gulf Coast of Mississippi suffered massive damage from the impact of Hurricane Katrina on August 29, 2005, leaving 236 people dead, 67 missing, and an estimated $125 billion in damages. Mississippi's healthcare system has been seriously disrupted, resulting in new health problems for people living in affected areas. The grant will provide an opportunity to address these health problems and to aid in restructuring the healthcare system.
Request for Information: Development and Implementation of Electronic Benefits Transfer System for Victims of Disaster To Receive Federal and State Benefits
HHS invites all comments, suggestions, recommendations and creative ideas on the feasibility of establishing a system of Electronic Benefits Transfer (EBT) as a simple, comprehensive, and efficient means to deliver to disaster victims the Federal, State and local human services for which they qualify. This Request for Information (RFI) is intended to provide ideas for consideration, and may or may not result in a future procurement.
Government-Owned Inventions; Availability 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.
National Institute of Allergy and Infectious Diseases; Cooperative Research and Development Agreement (CRADA) Opportunity for Furthering the Development of a Suite of Computer Programs for Modeling and Simulating Complex Cellular Biological Processes
The National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH), Department of Health and Human Services (HHS), seeks to enter into a CRADA with a commercial partner to co-develop a suite of computer programs for modeling and simulating complex cellular biological processes. The existing suite of computer programs allows biologists to develop and test quantitative models of cell biological processes. The graphical interfaces of the programs make it possible to develop realistic models of molecular interactions and cellular processes that take into account the intracellular and extracellular spatial inhomogeneity of signaling components without the user having to deal with the partial differential equations and state automata that underlie the quantitative simulation of the models. The program suite offers graphical symbols and drag-and-drop mechanisms to define molecular interactions, molecular complexes, cellular stimulus-response mechanisms, and the structure of extracellular compartments. An intuitive graphical interface can be used to inspect and interact with running simulations; for example, molecules and cells can be placed into the simulated compartments, cells can be selected for detailed analysis of their behavior and intracellular, spatially-resolved biochemistry. One part of the program suite reads the molecular interaction network data that are generated by the program based on the user defined bimolecular interactions and displays them as interaction graphs, visualizing the reaction dynamics in the modeled cellular signaling pathways. It is anticipated that the collaboration will result in the commercialization of the software.
Determination of Regulatory Review Period for Purposes of Patent Extension; CUBICIN
The Food and Drug Administration (FDA) has determined the regulatory review period for CUBICIN 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 that claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; DUTASTERIDE
The Food and Drug Administration (FDA) has determined the regulatory review period for DUTASTERIDE 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 that claims that human drug product.
Citizen's Health Care Working Group Interim Recommendations
The Citizens' Health Care Working Group (the Working Group), authorized by section 1014 of the Medicare Modernization Act, is publishing interim recommendations and requesting public comment on them.
Meeting of the Citizens' Health Care Working Group
In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces a meeting of the Citizens' Health Care Working Group (the Working Group) mandated by section 1014 of the Medicare Modernization Act.
Prescription Drug Marketing Act Pedigree Requirements; Effective Date and Compliance Policy Guide; Request for Comment
The Food and Drug Administration (FDA) does not intend to further delay the effective date of certain provisions of the final regulation published in the Federal Register of December 3, 1999 (64 FR 67720). The provisions will therefore go into effect on December 1, 2006. In addition, FDA is announcing the availability of a new compliance policy guide (CPG) 160.900 entitled ``Prescription Drug Marketing Act Pedigree Requirements Under 21 CFR Part 203'' for public comment. This CPG describes how the agency intends to prioritize its enforcement efforts during the next year with respect to pedigree requirements set forth in the Federal Food, Drug, and Cosmetic Act (the act) and certain FDA regulations.
Determination of Regulatory Review Period for Purposes of Patent Extension; TYGACIL
The Food and Drug Administration (FDA) has determined the regulatory review period for TYGACIL 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; RESTYLANE
The Food and Drug Administration (FDA) has determined the regulatory review period for RESTYLANE 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 medical device.
Administration for Native Americans
The Administration for Native Americans (ANA) herein announces a Program Expansion Supplement to the Red Lake Band of Chippewa Indians, Red Lake, Minnesota. This supplement for $136,400 will extend funding for 11 youth volunteers through the second year of the project. In FY 2005, ANA provided an urgent grant award to the Tribe to assist in mitigating the effects of the tragic events of the school shooting in March 2005 that resulted in the death of students, faculty and staff. The shooting marked the highest death toll in U.S. school shootings since the Columbine High School massacre in April 1999. Due to the devastation created by the high school shooting, ANA is providing urgent financial assistance for minor renovations to the local community centers to support positive community development; funding to hire 11 volunteers to assist youth and members of the community in coping with this event; and building support systems, which will aid in preventing future tragedies.
Determination of Regulatory Review Period for Purposes of Patent Extension; UROXATRAL
The Food and Drug Administration (FDA) has determined the regulatory review period for UROXATRAL 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; LUVERIS
The Food and Drug Administration (FDA) has determined the regulatory review period for LUVERIS 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; INCRELEX
The Food and Drug Administration (FDA) has determined the regulatory review period for INCRELEX 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 that claims that human drug product.
Proposed Collection; Comment Request; Preventing Motor Vehicle Crashes Among Novice Teen Drivers
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Child Health and Human Development (NICHD), 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.
Secretary's Advisory Committee on Genetics, Health, and Society; Request for Public Comment
The Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS) is requesting public comment on a draft report on policy issues raised by the prospect of the U.S. undertaking a large population cohort project for the study of genes, environment, and disease. A copy of the report, ``Policy Issues Associated with Undertaking a Large U.S. Population Cohort Project on Genes, Environment, and Disease,'' is available electronically at https:// www4.od.nih.gov/oba/ sacghs/publiccomments.htm. A copy may also be obtained from the National Institutes of Health (NIH) Office of Biotechnology Activities (OBA) by e-mailing Ms. Amita Mehrotra at mehrotraa@od.nih.gov or calling 301-496-9838.
Secretary's Advisory Committee on Genetics, Health, and Society; Request for Public Comment
The Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS) is requesting public comment on a draft report on policy issues raised by the prospect of the U.S. undertaking a large population cohort project for the study of genes, environment, and disease. A copy of the report, ``Policy Issues Associated with Undertaking a Large U.S. Population Cohort Project on Genes, Environment, and Disease,'' is available electronically at https:// www4.od.nih.gov/oba/ sacghs/publiccomments.htm. A copy may also be obtained from the National Institutes of Health (NIH) Office of Biotechnology Activities (OBA) by e-mailing Ms. Amita Mehrotra at mehrotraa@od.nih.gov or calling 301-496-9838.
Office of the National Coordinator; American Health Information Community Biosurveillance Workgroup Meeting
This notice announces the sixth of the American Health Information Community Biosurveillance Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.)
Office of the National Coordinator; American Health Information Community Consumer Empowerment Workgroup Meeting
This notice announces the sixth meeting of the American Health Information Community Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.)
Office of the National Coordinator; American Health Information Community Electronic Health Records Workgroup Meeting
This notice announces the sixth meeting of the American Health Information Community Electronic Health Records Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
Office of the National Coordinator; American Health Information Community Chronic Care Workgroup Meeting
This notice announces the sixth meeting of the American Health Information Community Chronic Care Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, U.S.C., App.).
Announcement of Availability of Funds for Cooperative Agreement to the Fundación México-Estados Unidos para la Ciencia, A.C. (FUMEC) (United States-Mexico Foundation for Science) to Support Mexican Outreach Offices
The Office of Global Health Affairs (OGHA) announces up to $600,000 in FY 2006 funds is available for a cooperative agreement to the Fundaci[oacute]n M[eacute]xico-Estados Unidos para la Ciencia, A. C. (FUMEC) (United States-Mexico Foundation for Science) to support the implementation, management, and administration of U.S.-Mexico Border Health Commission (USMBHC) programs and activities at the Mexican Outreach Offices. This initiative will support the development, administration, and evaluation of programs in specified health areas, including training for health personnel, development, and dissemination of educational materials and workshops, research, community outreach, health promotion, and improvement of information technology to enhance program support. HHS/OGHA will approve the budget period to be one year and the project period for up to a five-year period for a total of $600,000 (including indirect costs). Funding for the cooperative agreement is contingent upon the availability of funds.
Announcement of Cooperative Agreement With Morehouse School of Medicine
This announcement is made by the United States Department of Health and Human Services (HHS or Department), Office of Minority Health (OMH) located within the Office of Public Health and Science (OPHS), and working in a ``One-Department'' approach collaboratively with participating HHS agencies and programs (entities). The mission of the OMH is to improve the health of racial and ethnic minority populations through the development of policies and programs that address disparities and gaps. OMH serves as the focal point in the HHS for leadership, policy development and coordination, service demonstrations, information exchange, coalition and partnership building, and relation efforts to address the health need of racial and ethnic minorities. This announcement supports the Healthy People 2010 overarching goal to eliminate health disparities. As part of a continuing HHS effort to improve the health and well being of racial and ethnic minorities, the Department announces a sole source umbrella cooperative agreement award to the Morehouse School of Medicine.
Support and Capacity Building for an Expansion of the Medical Reserve Corps and a Demonstration of the Public Health Service Auxiliary
This announcement is made by the United States Department of Health and Human Services (HHS or Department), Medical Reserve Corps (MRC) program, located within the Office of the Secretary, Office of Public Health and Science (OPHS), Office of the Surgeon General (OSG), Office of Force Readiness and Deployment (OFRD). Background Information: During his January 2002 State of the Union address, President George W. Bush called on all Americans to dedicate at least two yearsthe equivalent of 4,000 hours of their timeto provide volunteer service to others. To help every American answer the call to service, the President created the USA Freedom Corps, and charged it with strengthening and expanding service opportunities for volunteers to protect our homeland, to support our communities, and to extend American compassion around the World. Simultaneously, the President also created the Citizen Corps, within the Department of Homeland Security (DHS), as a way to offer Americans new opportunities to get involved in their communities through emergency preparation and response activities. Along side Citizen Corps are several partner programs that share the common goal of helping communities prevent, prepare for, and respond to crime, natural disasters, and other emergencies. These partner programs include: Community Emergency Response Teams (CERT), also under DHS; Neighborhood Watch and Volunteers in Police Service, under the direction of the Department of Justice; Fire Corps; and the Medical Reserve Corps. The MRC is a nationwide network of community-based, citizen volunteer units, which have been initiated and established by local organizations for their communities. MRC units are local assets to meet locally determined needs. Medical and public health volunteers in the MRC can utilize their professional expertise to contribute to local public health initiatives, such as those meeting the Surgeon General's priorities for public health, on an ongoing basis and to supplement the existing response capabilities of the community in emergencies. Communities across the country are beginning to recognize that strengthening the everyday public health infrastructure will improve preparedness. The MRC was developed following the events of September 11, 2001, when many medical and public health professionals showed up at the disaster sites to support the response efforts and were mostly turned away due to identification, credentialing, and liability issues. One of the primary functions of the MRC is to resolve issues of pre- identifying and preparing volunteer health professionals for emergencies. The MRC brings volunteershealth professionals and otherstogether to supplement existing local resources in cities, towns, and counties throughout the United States. MRC volunteers include medical and public health professionals such as physicians, nurses, pharmacists, dentists, veterinarians, physician assistants, nurse practitioners, paramedics, EMTs, mental health workers, and epidemiologists. Many other community members interpreters, chaplains, office workers, legal advisors, etc.can fill key support positions. Many of these professionals have active practices in a variety of settings; others are in training; some are retired; and yet others are licensed but do not maintain an active practice. As this is a community-based program, each MRC is responsible for determining its own structure and developing its own policies and procedures. MRC units may be established and implemented by local government agencies, non-governmental organizations, or other non- profit entities. Partnerships with local medical, public health and emergency management entities are essential. The MRC Demonstration Project (started in FY 2002 and continued in FY 2003) provided start-up grants to 166 communities across the US. Other communities have been encouraged to establish MRC units without HHS funding support. As of May 19, 2006, there were 431 MRC units in 49 States, the District of Columbia, Guam, and the U.S. Virgin Islands, with more than 75,000 volunteers. The OSG has lead responsibility within HHS for the development of the MRC. OSG undertook this responsibility in March 2002 and subsequently created the MRC Program Office, with a mission to provide national and regional leadership, in partnership with key stakeholders, to facilitate local efforts to establish, implement, and sustain MRC units. The MRC program office facilitates the formation and implementation of MRC units in communities across the nation by coordinating mechanisms for information sharing and providing forums for discussions of promising practices and lessons learned. The major MRC program office activities include policy development, interagency coordination, program management, grants management, contract oversight, technical assistance, and outreach. Since its inception, the MRC program office has: Implemented the MRC Demonstration Project, which awarded small grants (of up to $50,000 per year for 3 years) to help jump start the establishment of local MRC units. Forty-two grants were awarded in September 2002 and an additional 124 grants were awarded in October 2003. Encouraged the development of MRC units in communities outside of the MRC Demonstration Project. As of May 19, 2006, over 260 additional communities have registered MRC units without receiving grant funding through the MRC program office. Developed a technical assistance contract to provide valuable expert advice to developing and established MRC units. A series of technical assistance documents were written to serve as a guide for local leaders to assist with establishment and implementation of MRC units. Established an MRC Web site (https://www.medicalreservecorps.gov) with resources for developing and established MRC units. The Web site includes an electronic message board and document clearinghouse to allow MRC communities to share information. Held consultation meetings with numerous governmental and non- governmental organizations at the local, State, regional, and national levels. Displayed the MRC exhibit booth at professional conferences to boost awareness of the program. Conducted leadership conferences at the national and regional levels to facilitate coordination, cooperation, and information sharing. Coordinated the MRC response following the 2005 Hurricanes. An estimated 6,000 MRC volunteers supported the response and recovery efforts in their local communities. In the hardest hit areas, and as the storm forced hundreds of thousands of Americans to flee the affected areas, MRC volunteers were ready and able to help when needed and were there to assist as evacuees were welcomed into their communities. These volunteers spent countless hours helping the many people whose lives were upended by these disastrous events. During the 2005 Hurricane Response, MRC volunteers throughout the nation served their local communities by: Establishing medical needs shelters to serve medically fragile and other displaced people; Staffing and providing medical support in evacuee shelters and clinics; Filling in locally at hospitals, clinics and health departments for others who were deployed to the disaster-affected regions; Immunizing responders prior to their deployment to the disaster affected regions; Staffing a variety of response hotlines created after the hurricanes hit; Raising funds for those affected by the hurricanes; Teaching emergency preparedness to community members; and Recruiting more public health and medical professionals who can be credentialed, trained and prepared for future disasters that may affect their hometowns or elsewhere. In addition to this local MRC activity, over 1,500 MRC members expressed a willingness to deploy outside their local jurisdiction on optional missions to the disaster-affected areas with their state agencies, the American Red Cross (ARC) and the U.S. Department of Health and Human Services (HHS). Of these, approximately 200 volunteers from 25 MRC units were hired by HHS as unpaid temporary Federal employees and more than 400 volunteers from over 80 local MRC units have been deployed to support ARC disaster operations in areas along the Gulf coast. Future Direction: Though the MRC was developed as a network of local, community-based assets established to meet locally determined needs, much national attention has been focused on the program in light of its astounding growth and its response following the 2005 Hurricanes. This attention has led to a call for an expansion of the MRC program. For example, in 2005 the White House Homeland Security Council charged HHS to establish systems to pre-enroll, credential, train, and deploy MRC members who are willing to provide emergency health and medical services after a catastrophic event. More recently, in the February 2006 Federal Response to Hurricane Katrina: Lessons Learned document, the White House recommended that ``HHS should organize, train, equip, and roster medical and public health professionals in preconfigured and deployable teams'' to include the PHS Commissioned Corps, members of the MRC, and other Federal partners. In support of the President's national strategies, in keeping with the National Response Plan and consistent with the charge from the Homeland Security Council, this single-eligibility cooperative agreement with the National Association of County and City Health Officials (NACCHO) will support HHS efforts to expand the capacity of MRC units throughout the nation. All work will be closely coordinated with OSG, the MRC program office, State coordinators, MRC regional coordinators, Regional Health Administrators and other Federal officials. NACCHO will begin by providing capacity-building support to all interested MRC units. NACCHO will also assist with the development of a comprehensive operational manual and support OSG efforts in credentialing, verifying backgrounds, badging, assessing levels of training, and utilizing MRC members who are willing and able to deploy with HHS as unpaid temporary Federal employees on national-level responses (keeping in mind that any employment of individuals is under the authority of HHS and will follow Federal employment standards). This subset of MRC members will be referred to as the ``Public Health Service Auxiliary.'' In addition, a Demonstration Project of the Public Health Service Auxiliary will be initiated, primarily targeting MRC units in geographic locations in the vicinity of the proposed PHS Rapid Deployment Force (RDF) teams: Washington DC/Baltimore; Georgia/North Carolina/South Carolina; Texas/ Oklahoma; and Arizona/New Mexico. Ultimately, this cooperative agreement with NACCHO will enhance the collaboration and coordination between OSG and community/state public health and emergency agencies to support and increase the MRC capacity to meet local, state and national needs.
Office of the National Coordinator; American Health Information Community Meeting
This notice announces the sixth meeting of the American Health Information Community in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C. App.) The American Health Information Community will advise the Secretary and recommend specific actions to achieve a common interoperability framework for health information technology (IT).
Carbinoxamine Products; Enforcement Action Dates
The Food and Drug Administration (FDA) is announcing its intention to take enforcement action against unapproved drug products containing carbinoxamine and persons who cause the manufacture of such products. Numerous drug products containing carbinoxamine are marketed without approved applications and many are inappropriately labeled for use in infants and young children. Drug products containing carbinoxamine are new drugs that require approved applications. One firm has approved applications to market products containing carbinoxamine. In addition, there is information showing that carbinoxamine should not be used in children under 2 years of age. Manufacturers who wish to market carbinoxamine products that do not already have FDA approval must obtain FDA approval of a new drug application (NDA) or an abbreviated new drug application (ANDA). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance entitled ``Marketed Unapproved Drugs Compliance Policy Guide.''
Guidance on Marketed Unapproved Drugs; Compliance Policy Guide; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Marketed Unapproved Drugs Compliance Policy Guide.'' The guidance describes how FDA intends to exercise its enforcement discretion with regard to drugs marketed in the United States that do not have required FDA approval for marketing. This document supersedes section 440.100 entitled ``Marketed New Drugs Without Approved NDAs or ANDAs'' (CPG 7132c.02) of the Compliance Policy Guide (CPG). It applies to any new drug required to have FDA approval for marketing, including new drugs covered by the over-the- counter (OTC) review.
Determination of Regulatory Review Period for Purposes of Patent Extension; CETROTIDE
The Food and Drug Administration (FDA) has determined the regulatory review period for CETROTIDE 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 that claims that human drug product.
Government-Owned Inventions; Availability 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.
Assistant Secretary for Planning & Evaluation Medicaid Program; Meeting of the Medicaid Commission
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, 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.
National Vaccine Injury Compensation Program: Calculation of Average Cost of a Health Insurance Policy
Subtitle 2 of Title XXI of the Public Health Service Act, as enacted by the National Childhood Vaccine Injury Act of 1986, as amended (the Act), governs the National Vaccine Injury Compensation Program (VICP). The VICP, administered by the Secretary of Health and Human Services (the Secretary), provides that a proceeding for compensation for a vaccine-related injury or death shall be initiated by service upon the Secretary, and the filing of a petition with the United States Court of Federal Claims (the Court). In some cases, the injured individual may receive compensation for future lost earnings, less appropriate taxes and the ``average cost of a health insurance policy, as determined by the Secretary.'' The Secretary now proposes a new method of calculating the average cost of a health insurance policy.
Alltech, Inc.; Withdrawal of Food Additive Petition
The Food and Drug Administration (FDA) is announcing the withdrawal, without prejudice to a future filing, of a food additive petition (FAP 2253) proposing that the food additive regulations be amended to provide for the safe use of polyurethane polymer coating in ruminant feed.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Evaluation of Consumer-Friendly Formats for Brief Summary in Direct-to-Consumer Print Advertisements for Prescription Drugs: Study 1
The Food and Drug Administration (FDA) is announcing that a collection of information entitled `` Evaluation of Consumer-Friendly Formats for Brief Summary in Direct-to-Consumer Print Advertisements for Prescription Drugs: Study 1'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Oral Dosage Form New Animal Drugs; Oxibendazole Suspension
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 Pfizer, Inc. The supplemental NADA provides for revised food safety labeling for oxibendazole suspension administered orally to horses as an antiparasitic.
Industry Exchange Workshop on Food and Drug Administration Clinical Trial Requirements; Public Workshop
The Food and Drug Administration (FDA) Minneapolis District, in cooperation with the Association of Clinical Research Professionals (ACRP), 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, August 23, 2006, from 8 a.m. to 5 p.m. and Thursday, August 24, 2006, from 8:30 a.m. to 12 noon. Location: The public workshop will be held at The Northland Inn, 7025 Northland Dr., Brooklyn Park, MN 55428, 800-441-6422 or 763-536- 8300, FAX: 763-536-8790. Contact: Amy C. Johnson, Public Affairs Specialist, Food and Drug Administration, 212 3rd Ave. South Minneapolis, MN 55401, 612-758-7131, FAX: 612-334-4134, e-mail: amy.johnson@fda.hhs.gov. Registration: Send registration information (including name, title, firm name, address, telephone, and fax number) and the registration fee of $220 (ACRP Minnesota chapter member), $280 (nonmember), or $220 (Government employee). Make registration fee payable to ACRP, and mail to the attention of Paul Below, 441 Timberland Dr., Burnsville, MN 55337. To register via the Internet please go to https://mnacrp.org/ or contact the ACRP webmaster at webmaster@mnacrp.org. (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 Paul Below for ACRP at 441 Timberland Dr., Burnsville, MN 55337, 952-882-4083, FAX: 952-223-1665, e-mail: webmaster@mnacrp.org. Attendees are responsible for their own accommodations. To make reservations at the Northland Inn at a rate of $119.00 plus tax, please contact the Northland Inn (see Location). 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 Amy Johnson (see Contact) at least 7 days in advance of the workshop.
Oral Dosage Form New Animal Drugs; Oxibendazole Paste
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 Pfizer, Inc. The supplemental NADA provides for revised food safety labeling for oxibendazole paste administered orally to horses as an antiparasitic.
Findings of Scientific Misconduct
Notice is hereby given that the Office of Research Integrity (ORJ) and the Assistant Secretary for Health have taken final action in the following case: Steven Anthony Leadon, Ph.D., University of North Carolina: Based on the report of an investigation conducted by the University of North Carolina (UNC) at Chapel Hill and additional analysis conducted by ORI in its oversight review, the U.S. Public Health Service (PHS) found that Steven Anthony Leadon, Ph.D., former Professor of Radiation Oncology, Department of Radiology, School of Medicine, UNC, engaged in scientific misconduct while supported by National Cancer Institute (NCI), National Institutes of Health (NIH), grant R01 CA40453-09 to 15. Specifically, PHS found that Dr. Landon engaged in scientific misconduct by falsifying DNA samples and constructing falsified figures for experiments done in his laboratory to support claimed findings of defects in a DNA repair process that involved rapid repair of DNA damage in the transcribed strand of active genes, included in four grant applications and in eight publications and one published manuscript, which were included as an Appendix to the Voluntary Exclusion Agreement entered into by Dr. Leadon and are as follows: Figures 1, 2, and 3 in the article by Gowen, L.C., Avrutskaya, A.V., Latour, A.M., Koller, B.H., & Leadon, S.A. ``BRCAI Required for Transcription-Coupled Repair of Oxidation DNA Damage.'' Science 281:109-1012, 1988. In grant application 2 R01 CA40453-14 (p. 9), this article was used as justification for proposed research on BRCA1 and related proteins that may be required for transcription-coupled DNA repair of oxidative DNA damage. Data from the research reported in this paper was also used as preliminary data (Figure 2, p. 16) to support proposed experiments on BRCA1. Figures 1A, 2A, and 3 in the article by Leadon, S.A. & Avrutskaya, A. ``Differential Involvement of the Human Mismatch Repair Proteins, hMLH1 and hMSH2 in Transcription-coupled Repair.'' Cancer Research 57:3784-3791, 1997. Figures 1 and 3 in the article by Leadon, S.A. & Avrutskaya, A.V. ``Requirement for DNA Mismatch Repair Proteins in the Transcription Coupled Repair of Thymine Glycols in Saccharomyces cerevisiae.'' Mutation Research 407:177-187, 1998. Figures 7B and 7C in the article by Cressman, V.L., Backlund, D.C., Avrutskaya, A.V., Leadon, S.A., & Koller, B.H. ``Growth retardation, DNA repair defects, and lack of spermatogenesis in BRCA1- deficient mice.'' Molecular and Cellular Biology 19:7061-7075, 1999. Figures 1 A-D, 3A, 3C, ajd 3D and graphs in the unpublished manuscript by Rauscher, F. J. III, Jensen, D.E., Patel, G., Fredericks, W.J., Schultz, D.C., Proctor, M., Sekido, Y., Minna, J., Chernova, T.A., Wilkinson, K.D., Avrutskaya, A.V., & Leadon, S.A. ``BRCA1-associated ubiquitin hydrolase required for transcription- coupled repair of oxidative DNA damage.'' Submitted to Science on May 16, 2001. In figure 4 in grant application 2 R01 CA40453-14 (pp. 17- 18), data from this unpublished manuscript was used regarding BAP1 defects in TCR. Figure 1A and 3A in the article by Cooper, P.K., Nouspikel, T., Clarkson, S.g., and Leadon, S.A., ``Defective transcription-coupled repair of oxidative base damage in Cockayne syndrome patients from XP group G,'' Science 275: 9907ndash993, 1997. In NIH grant application R01 CA40453-10A1, some of the same data for XPG or XP-G/CS cells from this Science article were included by Dr. Leadon as graphs (Figures 4 and 5, pp. 25-27) before the Science paper was published. Figure 1C, 2A and 2B in the article by LePage, F., Kwoh, E.E., Avrutskaya, A., Gentil, A., Leadon, S.A., Sarasin, A., & Cooper, P.K. ``Transcription-coupled repair of 8-oxoguanine: requirement for XPG, TFIIH, and CSB and implications for Cockayne Syndrome.'' Cell 101:159-171, 2000. Figure 7 in grant application 1 R01 CA092390-01. Figures 1 and 2 and Table 1 in the article by Leadon, S.A., Barbee, S.L., & Dunn, A.B. ``The yeast RAD2, but not RAD1, gene is involved in the transcription-coupled repair of thymine glycols.'' Mutation Research 337:169-178, 1995. Figure 6 in the article Nouspikel, T., Lalle, P., Leadon, S.A., Cooper, P.K., & Clarkson, S.g. ``A common mutational pattern in Cockayne syndrome patients from xeroderma pigmentosum group G: Implications for a second XPG function,'' Proc. Nat. Acad. Sci. USA 94, 3116-3121, 1997. Dr. Leadon's position is that he did not engage in scientific misconduct. His position is that a systematic error was introduced into the experiments in question and he recognizes that it could have influenced or accounted for the results. Dr. Leadon states that he has entered into a Voluntary Exclusion Agreement (Agreement) because he cannot sustain the significant financial burden of a legal proceeding to resolve the disagreements between his position and that of HHS. By entering into this Agreement, Dr. Leadon has voluntarily agreed: (1) To exclude himself from knowingly contracting or subcontracting with any agency of the United States Government and from eligibility or knowing involvement in nonprocurement programs of the United States Government referred to as ``covered transactions'' as defined in the debarment regulations at 45 CFR Part 76 for a period of five (5) years, beginning on May 10, 2006; (2) To exclude himself from serving in any advisory capacity to PHS including, but not limited, to service on any PHS advisory committee, board, and/or peer review committee, or as consultant for a period of five (5) years, beginning on May 10, 2006; and (3) To submit letters of retraction to the editors of the journals listed below within ten (10) business days from the effective date of this Agreement, stating as follows:
Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Detention and Banned Medical Devices
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 information collection requirements for Administrative Detention and Banned Medical Devices.
Office of the National Coordinator for Health Information Technology; Nationwide Health Information Network Forum
This notice announces the first forum of the Office of the National Coordinator for Health Information Technology to address the Nationwide Health Information Network functional requirements. The Forum is open to the public and will discuss the requirements needed for a Nationwide Health Information Network that facilitates the accurate, appropriate, timely, and secure exchange of health information.
Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Olfactory Test Device; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Olfactory Test Device.'' This guidance document describes a means by which the olfactory test device may comply with the requirement of special controls for class II devices. It includes recommendations for validation of device performance and labeling. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify these device types into class II (special controls).
Medical Devices; Ear, Nose, and Throat Devices; Classification of Olfactory Test Device
The Food and Drug Administration (FDA) is classifying the olfactory test device into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Class II Special Controls Guidance Document: Olfactory Test Device.'' The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that is the special control for the device.
Medical Devices; Exception From General Requirements for Informed Consent
The Food and Drug Administration (FDA) is issuing this interim final rule to amend its regulations to establish a new exception from the general requirements for informed consent, to permit the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without informed consent in certain circumstances. The agency is taking this action because it is concerned that, during a potential terrorism event or other potential public health emergency, delaying the testing of specimens to obtain informed consent may threaten the life of the subject. In many instances, there may also be others who have been exposed to, or who may be at risk of exposure to, a dangerous chemical, biological, radiological, or nuclear agent, thus necessitating identification of the agent as soon as possible. FDA is creating this exception to help ensure that individuals who may have been exposed to a chemical, biological, radiological, or nuclear agent are able to benefit from the timely use of the most appropriate diagnostic devices, including those that are investigational.
2005 White House Conference on Aging
Pursuant to Section 10(a) of the Federal Advisory Committee Act as amended (5 U.S.C. Appendix 2), notice is hereby given that the Policy Committee of the 2005 White House Conference on Aging will discuss items related to the final report of the Conference during a conference call. The conference call will be open to the public to listen, with call-ins limited to the number of telephone lines available. Individuals who plan to call in and need special assistance, such as TTY, should inform the contact person listed below in advance of the conference call. This notice is being published less than 15 days prior to the conference call due to scheduling problems.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) allow the proposed information collection as part of an AHRQ contract for ``Privacy and Security Solutions for Interoperable Electronic Health Information Exchange'' (the Assessment). In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ is submitting a request to OMB for emergency review. AHRQ is requesting an emergency review of this collection because the information is needed for subsequent health information technology projects later this year. Because subcontracts were solicited and awarded to the States, it was not possible to accurately quantify the public burden earlier this year. Data collection subcontract proposals were solicited from States and until they were reviewed, selected, awarded and accepted, it was not possible to accurately quantify the public burden earlier.
The Data Measures, Data Composites, and National Standards To Be Used in the Child and Family Services Reviews
On November 7, 2005, the Administration for Children and Families (ACF) published a notice in the Federal Register soliciting comment regarding its proposal to replace the six data measures used as part of the assessment of State performance on the Federal Child and Family Services Review (CFSR) with six data composites (70 FR 67479). Based on the results of our data analyses and a review of comments from the field, ACF made the following decisions: The CFSR will use a State's performance on two individual data measures as part of the assessment of the State's substantial conformity with CFSR Safety Outcome 1Children are, first and foremost, protected from abuse and neglect. A national standard is established for each of these measures. The CFSR will use a State's performance on four data composites as part of the assessment of the State's substantial conformity with CFSR Permanency Outcome 1Children have permanency and stability in their living situations. A national standard is established for each of these data composites. This announcement presents the following information: The decisions made by the Children's Bureau regarding use of data composites for the Federal Child and Family Services Review (CFSR); The composites and additional data that will be used as part of the assessment of a State's substantial conformity with the CFSR requirements; and Descriptive statistics relevant to each composite and measure, including the score that will serve as the national standard for the second round of the CFSR. Where relevant, the announcement addresses key comments from the field in response to the Federal Register notice. The announcement also includes the following attachments: Attachment A: Data to be included in the CFSR State Data Profile. Attachment B: Methodology for Composite Construction.
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