Department of Health and Human Services March 2005 – Federal Register Recent Federal Regulation Documents
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Protection of Human Subjects, Proposed Criteria for Determinations of Equivalent Protection
The Office of Public Health and Science, Department of Health and Human Services (HHS) solicits public comment on criteria that have been recommended to the Office for Human Research Protections (OHRP) for making determinations of whether procedures prescribed by institutions outside the United States afford protections that are at least equivalent to those provided in the Federal Policy for the Protection of Human Subjects (codified by HHS as 45 CFR part 46, subpart A, and equivalent regulations of 14 Departments and Agencies, collectively referred to as the Federal Policy or the Common Rule).
Announcement of Availability of Funds for Family Planning General Training and Technical Assistance Projects
This announcement seeks applications from public and nonprofit private entities to establish and operate one general training and technical assistance project in each of the ten PHS regions. The purpose of the family planning general training program is to ensure that personnel working in Title X family planning service projects have the knowledge, skills, and abilities necessary for the effective delivery of high quality family planning services. General training also includes specialized technical assistance which consists of specific, specialized, or highly skilled family planning training that is usually provided to a single organization based on identified need. Successful applicants will be responsible for the development and overall management of the general training program within the PHS region for which the grant is awarded.
Notice of Funding Opportunity
The Office of Population Affairs (OPA) requests applications for family planning service delivery improvement research grants. Applied research projects are encouraged in one or more of the following priority areas: (1) Quality of care in the delivery of family planning services; (2) effective approaches and interventions for addressing the reproductive health needs of adolescents and incorporating family members (particularly parents or guardians) into decisions of adolescents regarding relationships and sex; (3) reproductive health needs of males, prevention-related decisions by males and appropriate strategies for reaching male clients; (4) knowledge base for incorporating a ``couples'' perspective into the delivery of family planning services; (5) effective organizational approaches for delivery of family planning services in conjunction with related services, particularly HIV prevention services; (6) dissemination of findings and translation of service delivery research into practice; (7) factors associated with increasing costs and the impact of such increasing costs on service delivery; and (8) effectiveness of Title X non-clinical services with regard to information and education activities. Regulations pertaining to grants for research projects are set out at 42 CFR part 52. Section 1008 of the PHS Act provides that ``none of the funds appropriated under this title shall be used in programs where abortion is a method of family planning.''
Medicare Program; Meeting of the Advisory Board on the Demonstration of a Bundled Case-Mix Adjusted Payment System for End-Stage Renal Disease Services
This notice announces the second public meeting of the Advisory Board on the Demonstration of a Bundled Case-Mix Adjusted Payment System for End-Stage Renal Disease (ESRD) Services. Notice of this meeting is required by the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)). The Advisory Board will provide advice and recommendations with respect to the establishment and operation of the demonstration mandated by section 623(e) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003.
Medicare and Medicaid Programs; Fire Safety Requirements for Certain Health Care Facilities; Amendment
This interim final rule with comment period adopts the substance of the April 15, 2004 temporary interim amendment (TIA) 00-1 (101), Alcohol Based Hand Rub Solutions, an amendment to the 2000 edition of the Life Safety Code, published by the National Fire Protection Association (NFPA). This amendment will allow certain health care facilities to place alcohol-based hand rub dispensers in egress corridors under specified conditions. This interim final rule with comment period also requires that nursing facilities install smoke detectors in resident rooms and public areas if they do not have a sprinkler system installed throughout the facility or a hard-wired smoke detection system in those areas.
Medicare Program; Hospital Conditions of Participation: Requirements for Approval and Re-Approval of Transplant Centers To Perform Organ Transplants; Extension of Comment Period
This notice extends the comment period for a proposed rule published in the Federal Register on February 4, 2005, (70 FR 6140). The proposed rule sets forth the requirements that heart, heart-lung, intestine, kidney, liver, lung, and pancreas transplant centers would be required to meet to participate as Medicare-approved transplant centers. These proposed revised requirements focus on an organ transplant center's ability to perform successful transplants and deliver quality patient care as evidenced by good outcomes and sound policies and procedures. We also proposed that approval, as determined by a center's compliance with the proposed data submission, outcome, and process requirements would be granted for 3 years. Every 3 years, approvals would be renewed for transplant centers that continue to meet these requirements. We proposed these revised requirements to ensure that transplant centers continually provide high-quality transplantation services in a safe and efficient manner. The comment period for the proposed rule is extended for 60 days.
Medicare and Medicaid Programs; Conditions for Coverage for Organ Procurement Organizations (OPOs); Extension of Comment Period
This notice extends the comment period for a proposed rule published in the Federal Register on February 4, 2005, (70 FR 6086). In that rule, we proposed to establish new conditions for coverage for organ procurement organizations (OPOs), including multiple new outcome and process performance measures based on donor potential and other related factors in each service area of qualified OPOs. We are proposing new standards with the goal of improving OPO performance and increasing organ donation. The comment period is extended for 60 days.
Medicare and Medicaid Programs; Hospital Conditions of Participation: Requirements for History and Physical Examinations; Authentication of Verbal Orders; Securing Medications; and Postanesthesia Evaluations
In this proposed rule, we propose revisions to four of the current hospital conditions of participation (CoPs) for approval or continued participation in the Medicare and Medicaid programs. We are proposing changes to the CoP requirements related to: Completion of a history and physical examination in the medical staff and the medical record services CoPs; authentication of verbal orders in the nursing service and the medical record services CoPs; securing medications in the pharmaceutical services CoP; and completion of the postanesthesia evaluation in the anesthesia services CoP. These proposals respond to concerns within the medical community that the current Medicare hospital CoPs are contrary to current practice and are unduly burdensome. The changes specified in this proposed rule are consistent with current medical practice and will reduce the regulatory burden on hospitals.
Medicare Program; Recognition of NAIC Model Standards for Regulation of Medicare Supplemental Insurance
This notice describes changes made by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to section 1882 of the Social Security Act (the Act), which governs Medicare supplemental insurance. This notice also recognizes that the Model Regulation adopted by the National Association of Insurance Commissioners (NAIC) on September 8, 2004, is considered to be the applicable NAIC Model Regulation for purposes of section 1882 of the Act, subject to our clarifications that are set forth in this notice. Finally, the full text of the revised NAIC Model Regulation is included as an addendum to this notice. The NAIC has granted permission for the NAIC Model Regulation to be published and reproduced. Under 1 CFR 2.6, there is no restriction on the republication of material as it appears in the Federal Register.
Procedures for Non-Privacy Administrative Simplification Complaints Under the Health Insurance Portability and Accountability Act of 1996
This notice sets forth the procedures for filing with the Secretary of the Department of Health and Human Services a complaint of non-compliance by a covered entity with certain provisions of the administrative simplification rules under 45 CFR parts 160, 162, and 164. It also describes the procedures the Department employs to review the complaints. These procedures are intended to facilitate the investigation and resolution of these complaints.
Medicare, Medicaid, and CLIA Programs; Continuance of the Approval of the American Society for Histocompatibility and Immunogenetics as a CLIA Acreditation Organization
This notice announces the re-approval of the American Society for Histocompatibility and Immunogenetics (ASHI) as an accrediting organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. We have determined that the accreditation process of this organization provides reasonable assurance that the laboratories accredited by ASHI meet the conditions required by Federal law and regulations. Consequently, laboratories that are voluntarily accredited by ASHI and continue to meet the ASHI requirements will be deemed to meet the CLIA condition-level requirements for laboratories and therefore are not subject to routine inspection by State survey agencies to determine their compliance with Federal requirements. They are, however, subject to validation and complaint investigation surveys conducted by us or our designee.
Medicare Program; Meeting of the Medicare Coverage Advisory Committee-May 24, 2005
This notice announces a public meeting of the Medicare Coverage Advisory Committee (MCAC). 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 concerns the treatment of vertebral body compression fractures. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).
Medicare Program; Disapproval of Adjustment in Payment Amounts for New Technology Intraocular Lenses Furnished by Ambulatory Surgical Centers
In this final notice, we summarize timely public comments received in response to our July 23, 2004 notice with public comment period and announce our decision concerning applications submitted by Alcon Laboratories, Incorporated (Alcon) and Advanced Medical Optics (AMO) (formerly Pharmacia & Upjohn Company) \1\ to adjust the Medicare payment amounts for certain intraocular lenses (IOLs) on the basis that they are new technology intraocular lenses (NTIOLs).
Medicare and Medicaid Programs; Recognition of the American Osteopathic Association (AOA) for Continued Approval of Deeming Authority for Hospitals
This notice announces the Centers for Medicare & Medicaid Services' (CMS') reapproval of the American Osteopathic Association (AOA) as a national accreditation organization for hospitals that request participation in the Medicare program. We have determined that accreditation of hospitals by AOA demonstrates that all Medicare hospital conditions of participation are met or exceeded. Thus, CMS will continue to grant deemed status to those hospitals accredited by AOA.
Medicare and Medicaid Programs; Reapproval of the Deeming Authority of the Community Health Accreditation Program (CHAP) for Home Health Agencies
This notice announces our decision to approve the Community Health Accreditation Program for continued recognition as a national accreditation program for home health agencies seeking to participate in the Medicare or Medicaid programs.
Medicare and Medicaid Programs; Reapproval of the Deeming Authority of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) for Home Health Agencies
This notice announces our decision to approve the Joint Commission on Accreditation of Healthcare Organizations for continued recognition as a national accreditation program for home health agencies seeking to participate in the Medicare or Medicaid programs.
Medicare Program; Public Meetings in Calendar Year 2005 for All New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding and Payment Determinations
This notice announces the dates and location of the Healthcare Common Procedure Coding System (HCPCS) public meetings to be held in calendar year 2005 to discuss our preliminary coding and payment determinations for all new public requests for revisions to the HCPCS. These meetings provide a forum for interested parties to make oral presentations or to submit written comments in response to preliminary coding and payment determinations. Discussion will be directed toward responses to our specific preliminary recommendations and will include all items on the public meeting agenda.
Findings of Scientific Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) and the Acting Assistant Secretary for Health have taken final action in the following case: Eric T. Poehlman, Ph.D., University of Vermont: Based on the report of an investigation conducted by the University of Vermont (Report), admissions made by the respondent, and additional analysis conducted by ORI in its oversight review, the U.S. Public Health Service (PHS) found that Eric T. Poehlman, Ph.D., former Professor, Department of Medicine at the University of Vermont College of Medicine, engaged in scientific misconduct in research. The research was supported by National Institutes of Health (NIH) grants from the National Institute of Aging (NIA), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and the National Center for Research Resources (NCRR). Specifically, PHS found that the respondent is responsible for scientific misconduct by engaging in the misleading and deceptive practices set forth herein below:
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.
Eduardo Caro Acevedo; Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) debarring Dr. Eduardo Caro Acevedo for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Caro was convicted of a felony under Federal law for engaging in a conspiracy to defraud the United States and has demonstrated a pattern of conduct sufficient to find that there is reason to believe that he may violate requirements under the act relating to drug products. Dr. Caro failed to request a hearing and, therefore, has waived his opportunity for a hearing concerning this action.
Food and Drug Administration Regulations; Drug and Biological Product Consolidation; Addresses; Technical Amendment
The Food and Drug Administration (FDA) is amending certain regulations regarding biological products to include references to the Center for Drug Evaluation and Research (CDER) or the Director, CDER, and to include CDER address information or updated CDER address information, where appropriate. FDA is also amending the regulations to update mailing address information including mailing codes for the Center for Biologics Evaluation and Research (CBER), and to place the current mailing addresses for certain biologics regulations in a single location. These changes, among others, are being taken to reflect the reorganization between CBER and CDER due to the transfer of responsibility for certain products from CBER to CDER, and to ensure the consistency and accuracy of the regulations.
Child Care Bureau Research Scholars
The Administration for Children and Families' (ACF), Administration on Children, Youth and Families' (ACYF), Child Care Bureau (CCB) announces the availability of funds to support new CCB Research Scholar projects in Fiscal Year 2005. The Research Scholar Grants are designed to increase the number of graduate students conducting dissertation research on child care issues that are consistent with the Bureau's research agenda.
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