Department of Health and Human Services September 15, 2006 – Federal Register Recent Federal Regulation Documents
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International Development of H5N1 Influenza Vaccines; Funding Opportunity
The objective of this project is to mitigate any potential global shortage of influenza vaccines and the manufacturing of this vaccine in the event of an influenza pandemic. The Office of Public Health Emergency Preparedness (OPHEP) requires the World Health Organization (WHO) to perform activities related to pandemic influenza preparedness and planning, particularly in the international development of H5N1 human vaccines (and other pandemic influenza vaccine candidates) and influenza vaccine manufacturing infrastructure building in countries where resources for vaccine acquisition and manufacturing may be limited. The specific countries in which the WHO Secretariat will carry out these activities are Argentina, Brazil, India, Indonesia, Mexico, Romania, Russia, South Africa, and Tunisia. Activities include pre-clinical safety and immunogenicity testing, toxicology testing, clinical vaccine lot manufacturing, scale-up and process development, analytical lot release assay development and validation, and clinical immunogencity assay development and validation.
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.
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