Department of Health and Human Services August 25, 2005 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities; Proposed Collection; Comment Request; Financial Disclosure by Clinical Investigators
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 requiring the sponsor of any drug, biologic, or device marketing application to certify to the absence of clinical investigators and/or disclose those financial interests as required, when covered clinical studies are submitted to FDA in support of product marketing.
Medical Devices; Immunology and Microbiology Devices; Classification of Ribonucleic Acid Preanalytical Systems
The Food and Drug Administration (FDA) is classifying ribonucleic acid (RNA) preanalytical systems 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: RNA Preanalytical Systems (RNA Collection, Stabilization, and Purification Systems for RT-PCR Used in Molecular Diagnostic Testing).'' 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 a guidance document that will serve as the special control for the device.
Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Ribonucleic Acid Preanalytical Systems (Ribonucleic Acid Collection, Stabilization and Purification Systems for Real Time Polymerase Chain Reaction Used in Molecular Diagnostic Testing); Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: RNA Preanalytical Systems (RNA Collection, Stabilization and Purification Systems for RT-PCR used in Molecular Diagnostic Testing).'' This guidance document describes a means by which Ribonucleic Acid (RNA) preanalytical systems may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify RNA preanalytical systems into class II (special controls). This guidance document is immediately in effect as the special control for RNA preanalytical systems but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).
Research and Demonstration Projects for Indian Health
The Indian Health Service (IHS) announces the award of a cooperative agreement to the National Council of Urban Indian Health (NCUIH) for demonstration project for urban Indian health care education, consultation, health care data dissemination, training, and technical assistance to determine the unmet health care needs of urban Indians and to assist the Secretary in assessing the health status and health care of urban Indians. The project is for a three year project period effective September 1, 2005 to August 31, 2008. Annual funding for the project is $417,000. The award is issued under the authority of the Public Health Service Act, Section 301 and the Indian Health Care Improvement Act, Public Law 94-437, Sections 503, 504, and 511, and is listed under Catalog of Federal Domestic Assistance number 93-933. The specific objectives of the project are: 1. NCUIH will keep the Urban Indian health programs and the IHS informed of items of interest pertaining to the health status and unmet needs of urban Indians and the federal budget process by reviewing activities that have taken place in regard to Indian health care. 2. To disseminate information relative to Title V, local Urban Indian health issues, training opportunities, research instruments, data, budget, NCUIH activities and various forms of technical assistance to the Urban Indian health programs, keeping IHS informed of activities taking place. 3. To disseminate information and respond to all inquiries relative to Title V, local Urban Indian health issues, training opportunities, research instruments, data, budget, NCUIH activities and will issue a quarterly newsletter and develop a web page. 4. To coordinate meetings for the Urban Indian health programs to provide training, technical assistance, and/or updated information addressing the health care needs of Urban Indians. Reporting Requirements: 1. Monthly Activity Report: The organization will provide to the IHS program office a monthly report detailing activities performed for the organization. These activity reports will include: Trip reports for travel in connection to the organization Information on meetings attended by NCUIH regarding Indian health care education activities, and any documentation provided by NCUIH at these meetings Information relative to health status and health care needs of urban Indians in urban centers 2. Program Progress Report: Program progress reports are required semi-annually. These reports will include brief comparison of actual accomplishments to the goals established for the period, reasons for slippage (if applicable), and other pertinent information as required. A final report is to be submitted within 90 days of expiration of the budget/project period. 3. Financial Status Report: Financial status reports are required semi-annually. Standard Form 269 (long form) will be used for financial reporting. A final report must be submitted within 90 days of expiration of the budget/project period. 4. Financial Audit: A financial audit, conducted by an independent auditor will be completed annually for each year within the project period (three). Failure to submit required reports within the time allowed may result in suspension or termination of the active cooperative agreement, withholding of payments or converting to the reimbursement method of payment. Continued failure to submit required reports may result in the imposition of special award provisions, or cause other eligible projects or activities involving the grantee organization not to be funded. Justification for Single Source: This project has been awarded on a non-competitive single source basis. NCUIH is the only nationwide Indian organization that is specifically established to address the health needs of American Indians and Alaska Natives living in urban areas with membership consisting of Urban Indian health organizations funded under Title V of the Indian Health Care Improvement Act, Public Law 93-437, as amended, and under authority 25 U.S.C. 1652. Furthermore, it is the only nationwide organization for urban American Indians and Alaska Natives supporting the growth of the Urban Indian health care delivery system. Use of Cooperative Agreement: A cooperative agreement has been awarded because of anticipated substantial Programmatic involvement by IHS staff in the project. Substantial programmatic involvement is as follows: 1. IHS staff will participate in the Board of Director meetings. Purposes will be to present the IHS prospectus on current health care issues affecting the Urban Indian people and allow IHS the opportunity to hear the continuing unmet needs of Urban Indians. 2. IHS staff may, at the request of NCUIH, participate on study groups and may recommend topics for consideration. 3. IHS will be involved in the selection and approval process for hiring key personnel. Key personnel are the Executive Director, the Office Administrator, and may include the hiring of major consultants. NCUIH must submit the Executive Director and Office Administrator selection criteria to IHS for approval when there becomes a change in staffing.; 4. IHS will be involved in meetings held by NCUIH. Contacts: For program information, contact Ms. Danielle Steward, Program Specialist, Office of Urban Indian Health Programs, Office of the Director, Indian Health Service, Reyes Building, 801 Thompson Avenue, Rockville, MD, 20852, (301) 443-4680. For grants management information, contact Lois Hodge, Grants Management Officer, Division of Grants Operations, Reyes Building, 801 Thompson Avenue, Rockville, MD, 20852, (301) 443-5204.
Privacy Act of 1974; Report of Modified or Altered System
In accordance with the requirements of the Privacy Act of 1974, we are proposing to modify or alter an SOR, ``Health, Medical and Billing Records (formerly known as the Health and Medical Records Systems),'' System No. 09-17-0001. We propose to include contract health service records, as an additional category of individuals covered by the system, which consists of medical records to eligible American Indians and Alaska Native (AI/AN) people that supplements the health care resources available with the purchase of medical care and services that are not available within the IHS direct care system which may include, but not limited to, basic and specialty health care services from local and community health care providers, including hospital care, physician services, outpatient care, laboratory, dental, radiology, pharmacy, and transportation services. Under the Purpose of the system, we propose to include several new purposes that are in line with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule provisions which were incorporated into the published IHS Notice of Privacy Practices (NPP) and to include debt collection activities. We are proposing to modify/alter/delete several published routine uses, as explained, to accommodate for program and statutory changes as indicated: Number 1 is modified/altered by separating the medical treatment, payment and health care operations into two separate routine uses 1 and 2 to include payment, billing, third-party reimbursement and debt collection activities; numbers 3, 4 and 11 are to include business associate agreement language to comply with HIPAA Privacy standards and renumbered as 5, 6 and 12 respectively; number 5 is to include a special requirement notice for sensitive protected health information (PHI) such as alcohol/drug abuse, HIV/AIDS, STD or mental health patient information and renumbered as 7; number 6 is to reflect changes in research disclosures to comply with HIPAA Privacy standards and renumbered as 8; number 7 is to include various cases of abuses, neglect, sexual assault and domestic violence and emphasis on meeting the requirements of 42 CFR part 2 and renumbered as 9; number 8 is to clarify the disclosures regarding suspected cases of child abuse and renumbered as 10; number 9 is modified to include legal proceedings related to administrative claims and the inclusive provision of the Department of Health and Human Services (DHHS)/Office of General Counsel (OGC) representation in litigation matters and renumbered as 11; number 10 is modified to include business associate agreement language to comply with HIPAA Privacy standards and is renumbered as 5; numbers 12 and 16 are modified and incorporated into one proposed routine use 13 with minor edits; number 14 is modified to reflect the permitted use/ disclosure requirements of 45 CFR 164.502(g) and remains as 14; number 15 is modified with some minor edits to reflect current changes to enable efficient administration of health care operations and planning and delivery of patient medical care and renumbered as 18; and number 16 is being deleted and incorporated into the proposed routine use 13. We propose to add 10 new routine uses to provide disclosures of records when all requirements are met: number 2, to provide disclosure for third-part reimbursement, fiscal intermediary functions and debt collection activities; number 3, to provide disclosures to state Medicaid agencies or other entities acting pursuant to a contract with Centers for Medicare & Medicaid Services (CMS) for fraud and abuse control efforts to the extent required by law or under an agreement between IHS and respective state Medicaid agency or other entities; number 16, to an individual having authority to act on behalf of an incompetent individual concerning health care decisions to the extent permitted under 45 CFR 164.502(g); number 17, information may be used or disclosed from an IHS facility directory unless the individual objects to the disclosure and may provide the religious affiliation only to members of the clergy; number 18, information may be disclosed to a relative, a close personal friend, or any other person identified by the individual that is directly relevant to that person's involvement with their care or payment for health care and may be used or disclosed to notify family member, personal representative, or other person responsible for the individual's care, of their location, general condition or death; number 20, to provide records to Federal and non-Federal protection and advocacy organizations for investigating incidents of abuse and neglect of individuals with development disabilities as defined in 42 U.S.C. 10801-10805(a)(4) and 42 CFR 51.41-46 to the extent authorized by law and the conditions of 45 CFR 1386.22(a)(2) are met; number 21, disclosure to a correctional institution or a law enforcement official, during the period of time the individual is either an inmate or is otherwise in lawful custody, for the provision of health care to the individual or for health and safety purposes; number 22, disclosure to the Social Security Administration (SSA) for validation of Social Security Number(s) (SSNs) purposes only; number 23, disclosure of relevant health care information may be made to funeral director or representatives of funeral homes to allow for necessary arrangements; number 24, disclosure to a public or private covered entity that is authorized by law or charter to assist in disaster relief efforts. Routine use previously numbered 13 is deleted as being no longer applicable to the system. Routine uses previously numbered 2, 3, 4, 5, 6, 7, 8, 9, 11, 12, and 15 have been renumbered as 4, 6, 7, 8, 9, 10, 11, 12, 13, 14, and 19 respectively. The security classification previously reported as ``None'' will remain. We have modified the language in the routine uses to provide clarification to IHS' intention to disclose individual-specific information contained in this system. The routine uses will then be prioritized and reordered according to their usage. We will also take the opportunity to update any sections of the system notice to provide clarity on the changing environment to include for digital records and the initiative of transitioning from a paper-based record to a computerized-based or electronic medical record.
Definition of Primary Mode of Action of a Combination Product
The Food and Drug Administration (FDA) is amending its combination product regulations to define ``mode of action'' (MOA) and ``primary mode of action'' (PMOA). Along with these definitions, the final rule sets forth an algorithm the agency will use to assign combination products to an agency component for regulatory oversight when the agency cannot determine with reasonable certainty which mode of action provides the most important therapeutic action of the combination product. Finally, the final rule will require a sponsor to base its recommendation of the agency component with primary jurisdiction for regulatory oversight of its combination product by using the PMOA definition and, if appropriate, the assignment algorithm. The final rule is intended to promote the public health by codifying the agency's criteria for the assignment of combination products in transparent, consistent, and predictable terms.
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