Department of Health and Human Services September 2006 – Federal Register Recent Federal Regulation Documents
Results 151 - 200 of 266
Proposed Collection; Comment Request; NCI Cancer Information Service Base Demographics/Customer Service Data Collection
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 Cancer Institute (NCI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: NCI Cancer Information Service Base Demographics/Customer Service Data Collection. Type of Information Collection Request: Revision of currently approved collection 0925- 0208. Need and Use of Information Collection: The National Cancer Institute's Cancer Information Service (CIS) provides the latest information on cancer, clinical trials, and tobacco cessation. Characterizing clients and how they found out about the CIS is essential to customer service, program planning and promotion. This effort involves a brief survey of clients of the 1-800-4-CANCER and 1- 877-44U-QUIT toll-free services and LiveHelp, a web-based chat service. The telephone survey contains eight questions3 customer service and 5 demographicasked of a subset of callers (cancer patients, tobacco users, their family or friends, and the general public) at the end of usual service for an annual total of approximately 115,944 callers. All (100%) of these telephone clients will be asked the 3 customer service questions for an annual total of 113,061 callers. Of the 113,061 telephone clients we serve annually, 36% (n=40,702) will be randomly selected and asked five additional demographic questions. The LiveHelp web survey involves 50% of LiveHelp clients the same eight questions (3 customer service questions and 5 demographic questions) for an annual total of approximately 2,883 users. The combined total of clients to be surveyed each year for both telephone and LiveHelp services is 115,944 for a total of annual burden hours of 2,616. Frequency of Response: Single time. Affected Public: Individuals or households. Type of Respondents: Patients, relatives, friends, and general public. The annual reporting burden is as follows: Estimated Number of Respondents: 115,944; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: 0.0167 and Estimated Total Annual Burden Hours Requested: 2616. The annualized cost to respondents is estimated at: $47,323. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.
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 Vaccine Injury Compensation Program; List of Petitions Received
The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Listing of Color Additives Exempt From Certification; Mica-Based Pearlescent Pigments; Confirmation of Effective Date
The Food and Drug Administration (FDA) is confirming the effective date of July 5, 2006, for the final rule that appeared in the Federal Register of June 2, 2006 (71 FR 31927). The final rule amended the color additive regulations to provide for the safe use of titanium dioxide coated mica-based pearlescent pigments as color additives in the following foods: Cereals, confections and frostings, gelatin desserts, hard and soft candies (including lozenges), nutritional supplement tablets and gelatin capsules, and chewing gum.
Privacy Act of 1974; Report of a New System of Records
In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled, ``Chronic Condition Data Repository (CCDR), System No. 09-70-0573.'' The program is mandated by Section 723 of the Medicare Prescription Drug Improvement and Modernization Act of 2003 (MMA) (Public Law (Pub. L.) 108-173), which was enacted into law on December 8, 2003, and amended Title XVIII of the Social Security Act (the Act). The CCDR program seeks to establish a data repository to study chronically ill Medicare beneficiaries. This data repository will integrate existing data to support studies for improving the quality of care and studies for reducing the cost of care for chronically ill Medicare beneficiaries. The statute is designed to reduce program spending, make current Medicare program data more readily available to researchers to study chronic illness in the Medicare population, improve process time for research data request, focus on analytic prospective verses operational, and utilize data extraction tools to organize the data. The data collected and maintained in this system are retrieved from the following databases: Medicare Drug Data Processing System, System No. 09-70-0553 (70 Federal Register (FR) 58436 (October 6, 2005)); Medicare Beneficiary Database, System No. 09-70-0536 (66 FR 63392 (December 6, 2001)); Medicare Advantage Prescription Drug System, System No. 09-70-4001 (70 FR 60530 (October 18, 2005)); Medicaid Statistical Information System, System No. 09-70-6001 (67 FR 48906 (July 26, 2002)); Retiree Drug Subsidy Program, System No. 09-70-0550 (70 FR 41035 (July 15, 2005)); Common Working File, System No. 09-70- 0526 (67 FR 3210 (January 23, 2002)); National Claims History, System No. 09-70-0005 (67 FR 57015 (September 6, 2002)); Enrollment Database, System No. 09-70-0502 (67 FR 3203 (January 23, 2002)); Carrier Medicare Claims Record, System No. 09-70-0501 (67 FR 54428 (August 22, 2002)); Intermediary Medicare Claims Record, System No. 09-70-0503 (67 FR 65982 (October 29, 2002)); Unique Physician/Provider Identification Number, System No. 09-70-0525 (69 FR 75316 (December 16, 2004)); Medicare Supplier Identification File, System No. 09-70-0530 (67 FR 48184 (July 23, 2002)), A Current Beneficiary Survey, System No. 09-70-6002 (66 FR 15496 (March 19, 2001)); National Plan & Provider Enumerator System, System No. 09-70-0008, (63 FR 40297 (July 28, 1998)); Long Term Care MDS, System No. 09-70-1517 (67 FR 6714 (February 13, 2002)); HHA Outcome and Assessment Information Set, System No. 09-70-9002 (66 FR 66903 (December 27, 2001)); and Integrated Data Repository, System No. 09-70-0571 (To be published). The purpose of this system is to collect and maintain a person- level view of identifiable data to establish a data repository to study chronically ill Medicare beneficiaries. This system will utilize data extraction tools to support accessing data by chronic conditions and process complex customized research data requests related to chronic illnesses. Information retrieved from this system may be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, grantee, consultant or other legal agent; (2) assist another Federal or state agency with information to contribute to the accuracy of CMS's proper payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) support an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (4) support Quality Improvement Organizations (QIO); (5) support litigation involving the agency; and (6) combat fraud, waste, and abuse in certain Federally-funded health benefits programs. We have provided background information about the new system in the SUPPLEMENTARY INFORMATION section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See ``Effective Dates'' section for comment period.
Privacy Act of 1974; Report of a Modified or Altered System of Records
In accordance with the Privacy Act of 1974, we are proposing to modify or alter an existing SOR, ``Medicare Appeals System (MAS),'' System No. 09-70-5001, last published at 69 Federal Register (FR) 75323 (December 16, 2004). CMS is reorganizing its databases because of the impact of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Public Law (Pub.L.) 108-173) provisions and the large volume of information the Agency collects to administer the Medicare program. We propose to assign a new CMS identification number to this system to simplify the obsolete and confusing numbering system originally designed to identify the Bureau, Office, or Center that maintained the system of records. The new assigned identifying number for this system should read: System No. 09- 70-0566. We propose to broaden the scope of this system with the inclusion of support for two additional appeals processes: documenting policies and procedures relating to National Coverage Determinations and Prescription Drug Coverage appeals. These new processes are added to the current appeals process that include appeals of Medicare claims decisions, Administrative Law Judge hearings, and Medicare Advantage service decisions. We propose to modify existing routine use number 1 that permits disclosure to agency contractors and consultants to include disclosure to CMS grantees who perform a task for the agency. CMS grantees, charged with completing projects or activities that requires CMS data to carry out that activity, are classified separate from CMS contractors and/or consultants. The modified routine use will remain as routine use number 1. We propose to broaden the scope of routine uses number 5 and 6, authorizing disclosures to combat fraud and abuse in the Medicare and Medicaid programs to include combating ``waste'' which refers to specific beneficiary/recipient practices that result in unnecessary cost to all federally funded health benefit programs. We will delete routine use number 4, authorizing disclosure to support constituent requests made to a Congressional representative. If an authorization for the disclosure has been obtained from the data subject, then no routine use is needed. The Privacy Act allows for disclosures with the ``prior written consent'' of the data subject. We are modifying the language in the remaining routine uses to provide a proper explanation as to the need for the routine use and to provide clarity to CMS's intention to disclose individual-specific information contained in this system. We will also take the opportunity to update any sections of the system that were affected by the recent reorganization or MMA provisions and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of this modified system is to collect and maintain information necessary to: (1) Process level two and level three appeal requests made by an appellant or appealing party; (2) track appeal data, including: status, type, history, timeliness, and decisions; and (3) respond to future correspondence related to the case. The information retrieved from this system of records will also be disclosed to: (1) Support regulatory and policy functions performed within the agency or by a contractor, consultant, or grantee; (2) another Federal agency; (3) assist Quality Improvement Organizations; (4) support litigation involving the agency; and (5) combat fraud, waste, and abuse. We have provided background information about the modified system in the SUPPLEMENTARY INFORMATION section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the modified or altered routine uses, CMS invites comments on all portions of this notice. See ``Effective Dates'' section for comment period.
Prospective Grant of Exclusive License: Use of a Complete T-Cell Receptor Recognizing MART-1 Peptide Restricted by HLA-A2, Incorporated in a Continuous T-Lymphocyte Cell Line Developed or Owned by Licensee To Treat Cancer
This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. patent 5,830,755 filed March 27, 1995 [HHS Ref. No. E-093-1995/0-US-01] and Australian Patent 709122 filed March 27, 1996 [HHS Ref. No. E-093- 1995/0-AU-03], entitled T-Cell Receptors and Their Use in Therapeutic and Diagnostic Methods, to CellCure A/S, which is located in Aarhus, Denmark. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide and the field of use may be limited to the use of a complete T-cell receptor MART-1 peptide restricted by HLA-A2 incorporated into a continuous T-Lymphocyte cell line developed or owned by licensee to treat cancer.
Office of the National Coordinator for Health Information Technology; American Health Information Community Confidentiality, Privacy, and Security Workgroup Meeting
This notice announces the second meeting of the American Health Information Community (``the Community'') Confidentiality, Privacy, and Security Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.)
Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation; Withdrawal
The Health Resources and Services Administration (HRSA) and the Food and Drug Administration (FDA) published in the Federal Register of May 12, 2006 (71 FR 27606), a direct final rule to amend the regulations to consider as part of an organ those blood vessels recovered with the organ that are intended for use in organ transplantation; and to exclude such blood vessels from the definition of human cells, tissues, and cellular and tissue-based products. The comment period closed July 26, 2006. HRSA and FDA are withdrawing the direct final rule because FDA received significant adverse comment. The agencies will consider the comments received under our usual procedures for notice and comment in connection with the notice of proposed rulemaking that was published as a companion to the direct final rule (71 FR 27649).
Memorandum of Understanding Between the United States Food and Drug Administration and the National Cancer Institute
The purpose of this Memorandum of Understanding (MOU) is to set forth an agreement between the National Cancer Institute (NCI) and the Food and Drug Administration (FDA) (collectively ``the Parties'', or individually as a ``Party'') to develop and implement the Federal Investigator Registry of Biomedical Information Research Data (FIREBIRD), which will enable clinical investigators, NCI, FDA, and industry entities sponsoring clinical trials of investigational drugs (``Sponsors of Drugs and Biologics'' or ``Sponsors'') to manage clinical investigator information electronically in a fully secure manner.
New Animal Drugs for Use in Animal Feeds; Chlortetracycline
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 Alpharma Inc. The supplemental NADA provides for use of an approved Type A medicated article containing chlortetracycline to formulate a free-choice loose mineral Type C medicated feed for beef and nonlactating dairy cattle.
Draft Guidance for Industry on Drug Interaction Studies-Study Design, Data Analysis, and Implications for Dosing and Labeling; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Drug Interaction StudiesStudy Design, Data Analysis, and Implications for Dosing and Labeling.'' This document is intended to provide recommendations to sponsors of new drug applications (NDAs), and biologic license applications (BLAs) for therapeutic biologics (drugs) on carrying out in vitro or in vivo drug-drug interaction studies. The draft guidance reflects the current view that the metabolism and transport of a new drug should be defined during drug development and that its interactions with other drugs should be explored as part of an adequate assessment of the safety and effectiveness of the drug.
Training of Latin American Health Care Workers; Cooperative Agreement
This project will support the Gorgas Memorial Institute (GMI) to: (a) Develop a regional training center in Panam[aacute] and (b) train community health workers and clinicians (physicians, nurses, and auxiliary medical workers) and select public-health professionals from Central and South America, (c) facilitate partnerships (``twinning'') between U.S. universities and their Latin American counterparts to develop human resources for health in Latin America, and (d) harness the energies of U.S. and other non-governmental organizations by partnering with them to advance community health training and program efforts in Latin America. These efforts will contribute to improved and expanded provision of prevention and primary health care, and they will help engage significantly more areas of these countries to prepare for and respond to public health emergencies such as pandemic influenza. The training efforts of this project will place greater emphasis on the training of nurses and community health workers, rather than physicians, to reap the greatest improvement in expanded coverage and improved access to community, preventive and primary health care in underserved parts of Latin America (i.e., underserved rural and poor urban communities). In addition, as a result, the healthcare work force will be better prepared to respond to public health emergencies such as pandemic influenza. Key to the selection of recipients for this training will be their availability and willingness to commit to providing their health and medical care skills in underserved areas within the region. In addition to all appropriate medical care and health education or communication subjects, training supported by this project will emphasize infectious diseases, epidemiology, disease surveillance and outbreak response, among other subjects so graduates of training programs will be prepared to play contributing roles to any pandemic preparation and response.
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 project: ``Eisenberg Center Voluntary Customer Survey Generic Clearance for the Agency for Healthcare Research and Quality.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on July 5, 2006 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.
Proposed Data Collection; Comment Request; California Health Interview Survey 2007
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, National Cancer Institute (NCI), the National Institute of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. The first California Health Interview Survey (CHIS) Cancer Control Module (CCM) took place in 2001 (2000 CHIS CCM, OMB No. 0925-0478, Federal Register, May 8, 2000, Vol. 65, No. 89, p. 26620). The second survey took place in 2003 (2003 CHIS CCM, OMB No. 0925-0518, Federal Register, October 3, 2002, Volume 67, No. 192, pp. 62067-62068) and the third in 2005 (2005 CHIS CCM, OMB No. 0925-0000, Federal Register, Vol. 69, No. 150, Aug. 5, 2004, pp. 47450-47451, and Federal Register, Vol. 70, No. 1, Jan. 3, 2005, pp. 93-94). Proposed Collection: Title: California Health Interview Survey (CHIS) 2007 Cancer Control Module (CCM). Type of Information Collection Request: New. Need and Use of Information Collection: The NCI has sponsored three Cancer Control Modules in the California Health Interview Survey (CHIS), and will be sponsoring a fourth to be administered in 2007. Other Federal government agencies have co- sponsored previous cycles of the survey. The CHIS is a telephone survey designed to provide population- based, standardized health-related data to assess California's progress in meeting Healthy People 2010 objectives for the nation and the state. The CHIS sample is designed to provide statistically reliable estimates statewide, for California counties, and for California's ethnically and racially diverse population. Initiated by the UCLA Center for Health Policy Research, the California Department of Health Services, and the California Public Health Institute, the survey is funded by a number of public and private sources. It was first administered in 2001 to 55,428 adults, 5,801 adolescents, and 12,802 children; subsequently in 2003 to 42,043 adults, 4,010 adolescents, and 8,502 children; and in 2005 to 43,020 adults, 4,029 adolescents, and 11,358 children. These individuals are a representative sample of California's non- institutionalized population living in households. CHIS 2007, the fourth bi-annual survey, is planned for administration to 48,000 adult Californians. The cancer control module, which is similar to that administered in CHIS 2001, CHIS 2003, and CHIS 2005, will allow NCI and other Federal agencies to examine various health- and disease-related topics. Examples include patterns and (when fielded in multiple years) trends in breast cancer screening, diet, physical activity, obesity, tobacco control and other disease risk factors, disease outcomes, discrimination, and neighborhood cohesion. Because California is the most populous and the most racially and ethnically diverse state in the nation, the CHIS 2007 sample will yield adequate numbers of respondents in key ethnic and racial groups, including African Americans, Latinos, Asians, and American Indian/ Alaska Natives. The Latino group will include large numbers of respondents in the Mexican, Central American, South American, and other Latino subgroups; the Asian group will include large numbers of respondents in the Chinese, Filipino, Japanese, Vietnamese, and Korean subgroups. NCI and other Federal agencies will use the California and National Health Interview Survey (CHIS, NHIS) data to conduct comparative analyses and better estimate cancer risk factors and screening among racial/ethnic minority populations. The CHIS sample size also permits NCI and other federal agencies to obtain estimates for ethnic subdomains of the population, for which NHIS has insufficient numbers for analysis. Frequency of Response: One-time. Affected public: Individuals or households. Types of Respondents: U.S. adults (persons 18 years of age and older) and adolescents (persons of age 12-17 for whom the adult respondent is the parent or legal guardian of the adolescent residing in the household). The annual reporting burden is as follows.
Physician-Hospital Collaboration Demonstration
This notice is to inform interested parties of an opportunity to apply to participate in a demonstration under section 646 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), the Medicare Health Care Quality Demonstration, to examine the effects of gainsharing aimed at improving the quality of care in a health delivery system. More specifically, the demonstration will determine if gainsharing is an effective means of aligning financial incentives to enhance quality and efficiency of care across an entire system of care. In contrast to traditional models of gainsharing, which focus on the inpatient stay, this demonstration will examine approaches that involve long-term follow-up to assure both documented improvements in quality and reductions in the overall costs of care. Projects must also be of sufficient size to ensure statistical robustness of the results. CMS is particularly interested in demonstration designs that track patients well beyond a hospital episode, to determine the impact of hospital-physician collaborations on preventing short- and longer- term complications, duplication of services, coordination of care across settings, and other quality improvements that hold great promise for eliminating preventable complications and unnecessary costs. From the perspective of implementing and evaluating the demonstration, we also require some standardization of gainsharing approaches, physician payments, and hospital savings measurement across sites. Therefore, for the Section 646 Gainsharing Demonstration, CMS will operate projects submitted by consortia, comprising of health care groups and their affiliated hospitals. A limited number of projects will be operated in various geographic areas; no more than 72 hospitals can be included across all projects.
Office of the National Coordinator for Health Information Technology; American Health Information Community Consumer Empowerment Workgroup Meeting
This notice announces the ninth meeting of the American Health Information Community (``Community'') Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.)
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