Department of Health and Human Services August 2005 – Federal Register Recent Federal Regulation Documents

The Department of Health and Human Services, as part of its continuing efforts to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) (44 U.S.C. 3506(c)(2)(A)). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the IHS is providing a 60-day advance opportunity for public comment on a proposed extension of current information collection activity to be submitted to the office of Management and Budget for review.

The Food and Drug Administration (FDA) is announcing a series of educational workshops on current good manufacturing practice (CGMP). The workshops, which will be held in collaboration with Peking University (Beijing, China) and the International Society for Pharmaceutical Engineering (ISPE), are intended to educate participants on current methods for compliance with good manufacturing practices (GMP). The workshops are being offered to help ensure effective CGMP programs and to further the common goals of FDA and providers of quality pharmaceutical products.

Section 938 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 requires the Secretary to establish a process for Medicare contractors to provide eligible participating physicians and beneficiaries with a determination of coverage relating to medical necessity for certain physicians' services before the services are furnished. This rule is intended to afford the physician and beneficiary the opportunity to know the financial liability for a service before expenses are incurred. This proposed rule would establish reasonable limits on physicians' services for which a prior determination of coverage may be requested and discusses generally our plans for establishing the procedures by which those determinations may be obtained.

The Food and Drug Administration (FDA) is withdrawing approval of ten abbreviated new drug applications (ANDAs) held by Able Laboratories, Inc. (Able Labs), One Able Dr., Cranbury, NJ 08512. Able Labs has initiated a class II recall of the products covered by these ANDAs. The company has requested that the applications be withdrawn and has waived its opportunity for a hearing.

This interim final rule conforms our regulations to section 302(a)(2)(E)(iv) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-173). This rule defines the term power mobility devices (PMDs) as power wheelchairs and power operated vehicles (POVs or scooters). It sets forth revised conditions for Medicare payment of PMDs and defines who may prescribe PMDs. This rule also requires a face-to-face examination of the beneficiary by the physician or treating practitioner and a PMD prescription and pertinent parts of the medical record that the durable medical equipment supplier maintains in records and makes available to CMS or its agents upon request. Finally, this rule discusses CMS' policy on documentation that may be requested by CMS or its agents to support a Medicare claim for payment, as well as the elimination of the Certificate of Medical Necessity for PMDs.

This notice announces the final Federal share disproportionate share hospital (DSH) allotments for Federal fiscal years (FFYs) 2003 and 2004, and the preliminary Federal share DSH allotments for FFY 2005. It also announces the final FFYs 2003 and 2004, and the preliminary FFY 2005, limitations on aggregate DSH payments that States may make to institutions for mental disease (IMDs) and other mental health facilities. This notice also includes a background describing the methodology for determining the amounts of States' FFY DSH allotments for FFY 1998 and thereafter.

The Food and Drug Administration (FDA) is withdrawing approval of 16 new animal drug applications (NADAs) and 1 abbreviated NADA (ANADA) because the products are no longer manufactured or marketed. In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to remove portions reflecting approval of the NADAs.

This interim final rule with comment period sets forth the methodology used to compute State allotments that are available to pay Medicare Part B premiums for qualifying individuals, allows changes to the State allotments and describes the methodology used to determine the changes to each State's allotment.

This proposed notice announces that on September 26, 2005, we will begin to accept revisions from private accrediting organizations (AOs) who seek to modify their deeming authority.

This notice announces a Town Hall meeting on the Medicare Provider Feedback Group (MPFG). The purpose of the meeting is to solicit facts and opinions from individual Medicare providers and suppliers on a variety of Medicare policy and operational issues. All Medicare providers and suppliers that participate in the Medicare program, including physicians, hospitals, home health agencies, and other third-party billers, are invited to attend this meeting. We will consider facts and opinions obtained from individual Medicare providers and suppliers. The meeting is open to the public, but attendance is limited to space available.

This correcting amendment corrects a technical error in the correcting amendment that appeared in the Federal Register, entitled ``Medicare Program; Changes to the Medicare Claims Appeal Procedures: Correcting Amendment to an Interim Final Rule.''

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.

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).

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.

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 information collection requirements relating to the blood establishment registration and product listing requirements and Form FDA 2830.

The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on certain device panels of the Medical Devices Advisory Committee, the National Mammography Quality Assurance Advisory Committee, the Device Good Manufacturing Practice Advisory Committee, and the Technical Electronic Products Radiation Safety Standards Committee in the Center for Devices and Radiological Health. Nominations will be accepted for current vacancies and those that will or may occur through August 31, 2006. FDA has a special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on advisory committees and, therefore, encourages nominations of qualified candidates from these groups.

Provide a clear and concise summary of the proposed goals, major objectives and activities required for achievement of program goals and amount of funding requested for budget year one of this cooperative agreement. Laboratory Services 1. Perform routine QA/QC on rapid-testing specimens from all sites supported by the Emergency Plan for AIDS Relief until the national reference lab is operational. 2. Perform confirmational CD4 testing and analysis to determine clinical eligibility of patients for ART at expansion sites that lack the capacity to conduct such testing. 3. Perform confirmational STI testing for diagnosis. Training 1. Provide training in local languages to local health care professionals including physicians, nurses, lab technicians and pharmacy technicians, community health workers volunteers and appropriate program staff. a. Train how to design, implement and evaluate confidential VCT program sites to enable them to provide counseling and rapid testing for HIV/AIDS. b. Train social workers in providing psycho-social support to PLWHA and their families, including bereavement counseling, crisis management, and support for orphan and vulnerable children. c. Train health care professionals, in clinical care and treatment of HIV/AIDS/TB, OI and HAART including basic and palliative care. d. Train nurses and community health workers in care for PLWHAs, including counseling PLWHAs engaged in treatment and drug administration. e. Train pharmacists in drug-supply commodity management, forecasting, and packaging. f. Train lab technicians in use of automated laboratory equipment for hematology, biochemistry, biology. g. Train how to maintain laboratory equipment. h. Train in laboratory safety and proper disposal of bio-hazardous materials protocol. i. Train in the use of universal precautions and the management of needle-stick or splash injuries. j. Provide post-training follow-up to identify gaps in resources or effectiveness of particular protocols. k. Provide regular routine in-service trainings in local languages for health service and lab personnel to review new and best practice techniques and solicit ``insider insight''an account of implementation success and challenges. 2. Implement monitoring and evaluation strategies at each program site, assessing: a. Number of trainings held b. Number and type of participants c. Pre- and post-training skill levels d. Number of equipment maintenance calls. You may include additional information in the application appendices. The appendices will not count toward the narrative page limit. This additional information includes the following: Curricula Vitae or Resumes of current staff who will work on the activity Organizational Charts Letters of Support Project Budget and Justification for year one only The budget justification will not count in the narrative page limit. Although the narrative addresses activities for the entire project, the applicant should provide a detailed budget only for the first year of activities, while addressing budgetary plans for subsequent years. You must have a Dun and Bradstreet Data Universal Numbering System (DUNS) number to apply for a grant or cooperative agreement from the Federal Government. The DUNS number is a nine-digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy, and there is no charge. To obtain a DUNS number, access www.dunandbradstreet.com or call 1-866-705-5711. For more information, see the HHS/CDC Web site at: https:// www.cdc.gov/od/pgo/funding/pubcommt.htm. If your application form does not have a DUNS number field, please write your DUNS number at the top of the first page of your application, and/or include your DUNS number in your application cover letter. Additional requirements that could require you to submit additional documentation with your application are listed in section ``VI.2. Administrative and National Policy Requirements.''

The National Vaccine Program Office (NVPO), a program office within the Office of Public Health and Science, DHHS, is soliciting nominations of qualified candidates to be considered for appointment as members and representatives to the National Vaccine Advisory Committee (NVAC). The activities of this Committee are governed by the Federal Advisory Committee Act (FACA). Consistent with the National Vaccine Plan, the Committee advises and makes recommendations to the Assistant Secretary for Health in his/ her capacity as the Director of the National Vaccine Program, on matters related to the Program's responsibilities. Specifically, the Committee studies and recommends ways to encourage the availability of an adequate supply of safe and effective vaccination products in the United States; recommends research priorities and other measures to enhance the safety and efficacy of vaccines. The Committee also advises the Assistant Secretary for Health in the implementation of Sections 2102 and 2103 of the PHS Act; and identifies annually the most important areas of government and non-government cooperation that should be considered in implementing Sections 2102 and 2103 of the PHS Act.

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 record retention requirement of the soy protein/coronary heart disease health claim.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Gene Therapy Clinical TrialsObserving Participants for Delayed Adverse Events,'' dated August 2005. The draft guidance provides sponsors of gene therapy studies with recommendations regarding collection of data on delayed adverse events in participants who have been exposed to gene therapy products. When finalized, this guidance will supplement the recommendations in the ``Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors'' (Retroviral Vector guidance), dated October 2000, for study participant long-term followup. However, the recommendations in the Retroviral Vector guidance regarding the length of followup will be superseded by this Gene Therapy Clinical Trials guidance.

The Office for Human Research Protections (OHRP), a program office in the Office of Public Health and Science, Department of Health and Human Services (HHS), is seeking nominations of qualified candidates to be considered for appointment as members of the Secretary's Advisory Committee on Human Research Protections (SACHRP). SACHRP provides advice and recommendations to the Secretary, HHS, and the Assistant Secretary for Health on matters pertaining to the continuance and improvement of functions within the authority of HHS directed toward protections for human subjects in research. SACHRP was established by the Secretary, HHS, on October 1, 2002. OHRP is seeking nominations of qualified candidates to fill three positions on the Committee membership that will become vacant on January 1, 2006.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Phoenix Scientific, Inc. The supplemental ANADA provides for veterinary prescription use of flunixin meglumine solution by intravenous injection in lactating dairy cattle for control of fever associated with bovine respiratory disease and endotoxemia, and for control of inflammation in endotoxemia.

The Department of Health and Human Services published a document in the Federal Register of June 20, 2005 concerning a notice of funding availability to establish Area Poverty Research Centers. The document contained an incorrect date.

The President's Council on Bioethics (Leon R. Kass, M.D., Chairman) will hold its twenty-first meeting, at which, among other things, it will continue its discussion of ethical issues relating to the treatment of the aged and the long-term care of patients with dementia. Subjects discussed at past Council meetings (though not on the agenda for the present one) include: Cloning, assisted reproduction, reproductive genetics, IVF, ICSI, PGD, sex selection, inheritable genetic modification, patentability of human organisms, neuroscience, aging retardation, lifespan-extension, and organ procurement for transplantation. Publications issued by the Council to date include: Human Cloning and Human Dignity: An Ethical Inquiry (July 2002); Beyond Therapy: Biotechnology and the Pursuit of Happiness (October 2003); Being Human: Readings from the President's Council on Bioethics (December 2003); Monitoring Stem Cell Research (January 2004), Reproduction and Responsibility: The Regulation of New Biotechnologies (March 2004), and Alternative Sources of Human Pluripotent Stem Cells: A White Paper (May 2005).

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's address for Peptech Animal Health Pty, Ltd.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Sparhawk Laboratories, Inc. The ANADA provides for the veterinary prescription use of phenylbutazone injectable solution in horses for relief of inflammatory conditions associated with the musculoskeletal system.

This notice announces an administrative hearing to be held on September 15, 2005, at 12 noon, in the Virginia Room 229, 150 S. Independence Mall, West, Suite 216, Philadelphia, Pennsylvania 19106, to reconsider our decision to disapprove Maryland's State Plan Amendment (SPA) 05-06.

The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of ionizing radiation for control of Vibrio species and other foodborne pathogens in fresh or frozen molluscan shellfish (e.g., oysters, mussels, clams, etc.). This action is in response to a petition filed by the National Fisheries Institute and the Louisiana Department of Agriculture and Forestry.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The goal of this proposed rule is to increase immunization rates in Medicare and Medicaid participating long term care (LTC) facilities by requiring LTC facilities to offer each resident immunization against influenza annually, as well as lifetime immunization against pneumococcal disease. LTC facilities would be required to ensure that each resident receives an annual immunization against influenza and receives the pneumococcal immunization once, unless medically contraindicated or the resident or the resident's legal representative refuses immunization. Increasing the use of Medicare-funded preventive services is a goal of both CMS and the Centers for Disease Control and Prevention (CDC). This proposed rule is intended to increase the number of elderly receiving influenza and pneumococcal immunization and decrease the morbidity and mortality rate from influenza and pneumococcal diseases.

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.

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.

As stipulated by 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 will be open to the public.

The Office of Disease Prevention and Health Promotion (ODPHP), Office of Public Health and Science (OPHS), U.S. Department of Health and Human Services (HHS), acting on behalf of HHS and its lead agencies, as part of the process of conducting the Midcourse Review of Healthy People 2010, is soliciting written comments for consideration on changes and revisions proposed to the Healthy People 2010 objectives. Healthy People 2010, a set of national health objectives, was published by HHS in 2000. The Midcourse Review (MCR), conducted at the midpoint of the decade, is the process through which the Healthy People 2010 objectives are reviewed by HHS, the lead agencies, and other experts, to assess the data trends during the first half of the decade, consider new science and available data, and make changes that ensure that Healthy People 2010 remains current, accurate, and relevant. The proposed revisions take the form of: establishing baselines and targets for formerly developmental objectives (i.e., objectives that had no baseline data or target when Healthy People 2010 was released in 2000); changes to the language of objectives and subobjectives; deletions of objectives and subobjectives; new subobjectives; and baseline and target revisions.