Department of Health and Human Services February 2006 – Federal Register Recent Federal Regulation Documents
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State Median Income Estimate for a Four-Person Family (FFY 2007); Notice of the Federal Fiscal Year (FFY) 2007 State Median Income Estimates for Use Under the Low Income Home Energy Assistance Program (LIHEAP) Administered by the Administration for Children and Families, Office of Community Services, Division of Energy Assistance
This notice announces the estimated median income for four- person families in each State and the District of Columbia for FFY 2007 (October 1, 2006 to September 30, 2007). LIHEAP grantees may adopt the State median income estimates beginning with the date of this publication of the estimates in the Federal Register or at a later date as discussed below. This means that LIHEAP grantees could choose to implement this notice during the period between the heating and cooling seasons. However, by October 1, 2006, or by the beginning of a grantee's fiscal year, whichever is later, LIHEAP grantees using State median income estimates must adjust their income eligibility criteria to be in accord with the FFY 2007 State median income estimates. This listing of estimated State median incomes provides one of the maximum income criteria that LIHEAP grantees may use in determining a household's income eligibility for LIHEAP.
Submission for OMB Review; Comment Request; Women's Health Initiative Observational Study
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Director, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on November 7, 2005, page 67494 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. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised or implemented on or after October 1, 1995 unless it displays a current valid OMB control number.
Agency Information Collection Activities; Proposed Collection; Comment Request; Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition
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 labeling requirements for aluminum content in large volume parenterals (LVPs), small volume parenterals (SVPs), and pharmacy bulk packages (PBPs) used in total parenteral nutrition (TPN).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Focus Groups as Used by the Food and Drug Administration
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.
Medicare and Medicaid Programs; Approval of Deeming Authority of the Accreditation Commission for Healthcare (ACHC) for Home Health Agencies
This notice announces our decision to approve the Accreditation Commission for Healthcare (ACHC) for recognition as a national accreditation program for home health agencies seeking to participate in the Medicare or Medicaid programs.
Medicare Program; Request for Nominations for the Advisory Panel on Medicare Education
This notice requests nominations for individuals to serve on the Advisory Panel on Medicare Education (the Panel). The Panel advises and makes recommendations to the Secretary of Health and Human Services (HHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities for CMS to optimize the effectiveness of the National Medicare Education Program and other CMS programs that help Medicare beneficiaries understand the range of health plan options available under the Medicare program.
Notice of Hearing: Reconsideration of Disapproval of Iowa State Plan Amendments 05-003
This notice announces an administrative hearing to be held on April 13, 2006, at the Richard Bolling Federal Building, 601 E. 12th Street, Room 235, Kansas City Conference Room, Kansas City, MO 64106- 2898, to reconsider CMS' decision to disapprove Iowa State plan amendment 05- 003. Closing Date: Requests to participate in the hearing as a party must be received by the presiding officer by March 13, 2006.
Medicare and Medicaid Programs; Announcement of an Application From a Hospital Requesting a Waiver From Its Designated Organ Procurement Service Area
This notice announces a hospital's request for a waiver from entering into an agreement with its designated organ procurement organization (OPO), in accordance with section 1138(a)(2) of the Social Security Act. This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.
Debarment
Notice is hereby given that the Deputy Assistant Secretary for the Office of Acquisition Management and Policy of the Department of Health and Human Services (HHS) has taken final agency action in the following case: Paul H. Kornak, Stratton VA Medical Center, Albany, New York: Upon recommendations from the Office of Research Integrity (ORI), Acting Assistant Secretary for Health for the Department of Health and Human Services (HHS), the Office of Research Oversight (ORO), and the Under Secretary for Health, Department of Veterans Affairs (VA), that were based on the criminal convictions of making and using a materially false statement, in violation of 18 U.S.C. 1001(a)(3); mail fraud, in violation of 18 U.S.C. 1341 and 1346; and criminally negligent homicide, in violation of 18 U.S.C. 13 and New York Penal Law Sec. 125.10, the HHS debarring official has permanently debarred Mr. Paul Kornak, former research coordinator at the Stratton VA Medical Center. This action is taken pursuant to the HHS government-wide nonprocurement debarment and suspension regulation at 45 CFR part 76. As such, Mr. Kornak is excluded for life from participating in any and all Federal agency transactions, both procurement and nonprocurement, as set forth in part 76. Of the 48 criminal charges contained in his Indictment, Paul Kornak pled guilty to the three criminal charges listed above. See United States of America v. Paul H. Kornak, Criminal Action No. 03-CR-436 (FJS), U.S. District Court (N.D.N.Y.) (January 18, 2005). In addition to the 71-month term of imprisonment imposed, Mr. Kornak was directed to pay restitution to two pharmaceutical companies and the VA in the amount of approximately $639,000. As part of his guilty plea, Mr. Kornak admitted to the following facts: In August 2000, Mr. Kornak applied for employment to the VA, submitting a false ``Declaration for Federal Employment'' form. Mr. Kornak denied that he had been convicted or on probation in the preceding 10 years, whereas in fact, he had been convicted of mail fraud in 1992 and placed on probation for 3 years. By October of 2000, Mr. Kornak was responsible for organizing, coordinating, implementing, and directing all research elements in the Stratton VA Medical Center oncology research program. Specifically, Mr. Kornak was the site coordinator at the Stratton VA Medical Center for the ``Iron (Fe) and Atherosclerosis Study'' (FeAST), cancer studies known as Tax 325 and Tax 327, and a bladder cancer study. The FeAST study was a clinical trial that tested a novel procedure for controlling atherosclerosis, also known as hardening of the arteries, by reducing the iron in the body through blood drawing. The Tax 325 cancer treatment study involved the administration of pharmaceutical products to patients with metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease. The Tax 327 study involved the administration of pharmaceutical products to patients with metastatic hormone refractory prostate cancer. The purpose of the bladder cancer study, which was co- sponsored by the National Cancer Institute, National Institutes of Health, was to compare the use of difluoromethylornithine (DFMO) to the use of a placebo in patients with low grade superficial bladder cancer according to time to first recurrence of the tumor and toxicities. From May 14, 1999, to July 10, 2002, in connection with the above protocols, Mr. Kornak participated in a scheme to defraud the sponsors of the clinical studies in that ``he would and repeatedly did submit false documentation regarding patients and study subjects and enroll and cause to be enrolled persons as study subjects who did not qualify under the particular study protocol.'' Mr. Kornak caused the death of a study subject when he ``failed to perceive a substantial and unjustifiable risk that death would occur when he knowingly and willfully made and used * * * documents falsely stating and representing the results of [the study subject's] blood chemistry analysis * * *, which false documents purported that [the study subject] met the inclusion and exclusion criteria for participation in Tax 325 when the actual results did not meet the inclusion and exclusion criteria and showed impaired kidney and liver function, and [the study subject] thus was administered the chemotherapeutic drugs docetaxel, cisplatin, and 5-FU in connection with Tax 325 on or about May 31, 2001, and died as a result thereof on or about June 11, 2001.'' Based on the criminal conviction and the facts admitted to above, HHS and VA believe that a debarment period longer than the standard length of debarment is warranted in this case. Mr. Kornak admitted to a dishonest handling of the research records and demonstrated a complete disregard for the well-being of vulnerable human subjects under his care. In pleading guilty to criminally negligent homicide, Mr. Kornak admitted that a reasonable person would have perceived a substantial and unjustifiable risk of death if an ineligible subject were enrolled in the cancer study in question and that his failure to perceive such a risk in enrolling the ineligible subject constituted a gross deviation from the standard of care. Moreover, a longer debarment period is warranted in this case because of an established pattern of misconduct and criminal behavior on the part of Mr. Kornak. As stated above, Mr. Kornak has a prior conviction of mail fraud. In addition, the Office of Personnel Management excluded Mr. Kornak from all Federal nonprocurement transactions for an indefinite period, effective July 22, 1993. Nonetheless, beginning in 1999, Mr. Kornak actively participated in federally sponsored research protocols in violation of the imposed exclusion. A lifetime debarment of Mr. Kornak is necessary to protect the public interest overall. Given the scope of his criminal conviction, his longstanding pattern of criminal behavior, and his total disregard for the safety and well-being of human subjects, Mr. Kornak's responsibility to engage in transactions with the Federal Government cannot be assured at any time in the future.
Assistant Secretary for Planning and Evaluation; Medicaid Program; Meeting of the Medicaid Commission-March 13-15, 2006
This notice announces a public meeting of the Medicaid Commission. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)). The Medicaid Commission will advise the Secretary on ways to modernize the Medicaid program so that it can provide high-quality health care to its beneficiaries in a financially sustainable way.
Medicare Program; Inpatient Psychiatric Facilities Prospective Payment System Payment Update for Rate Year Beginning July 1, 2006 (RY 2007); Correction and Extension of Comment Period
This document corrects technical errors that appeared in the proposed rule entitled ``Medicare Program; Inpatient Psychiatric Facilities Prospective Payment System Payment Update for Rate Year Beginning July 1, 2006 (RY 2007).'' This correction notice also extends the public comment period for an additional 60 days, to allow the public an opportunity to comment on the correct Electroconvulsive Therapy (ECT) payment policy.
Memorandum of Understanding Between the United States Food and Drug Administration and the United States General Services Administration
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between the U.S. Food and Drug Administration and the U.S. General Services Administration (GSA) (collectively the Parties or individually a Party). The purpose of this MOU is to set forth an agreement between GSA and FDA regarding the roles, responsibilities, and financial commitments of each Party relating to FDA's agreement to coordinate, with GSA and its contractors, removal of a mercury-contaminated laboratory waste plumbing system; and GSA's agreement to coordinate, with FDA and its contractors, its scheduled hazmat removal and demolition work at Federal Office Building 8. It is the Parties' mutual desire to accomplish both actions in such a manner that controls and reduces the overall cost to the taxpayer.
Meetings on Patient Safety and Quality Improvement
We are considering how to implement the Patient Safety and Quality Improvement Act of 2005 (Act), including such questions as how the Act might be applied to various organizational configurations and how best to ensure that the statute's fundamental confidentiality objectives are achieved. To help us better understand the thinking and plans of providers that are interested in seeking out patient safety organization (PSO) services, and of entities that anticipate establishing such an organization, this notice invites the public to provide information that may assist the Agency, either in person or by telephone call-in, at three related public meetings.
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: ``Use of IT and Health IT Among Health Centers funded under Section 330 of the Public Health Service Act''. 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.
Medicare Program; Medicare Secondary Payer Amendments
This interim final rule with comment period implements amendments to the Medicare Secondary Payer (MSP) provisions under Title III of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). The MMA amendments clarify the MSP provisions regarding the obligations of primary plans and primary payers, the nature of the insurance arrangements subject to the MSP rules, the circumstances under which Medicare may make conditional payments, and the obligations of primary payers to reimburse Medicare.
Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2006 and Certain Provisions Related to the Competitive Acquisition Program of Outpatient Drugs and Biologicals Under Part B; Correcting Amendment
In the November 21, 2005 Federal Register (70 FR 70116), we published a final rule with comment period entitled ``Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2006 and Certain Provisions Related to the Competitive Acquisition Program of Outpatient Drugs and Biologicals Under Part B.'' This correcting amendment corrects technical errors in the November 21, 2005 publication.
Listing of Color Additives Exempt From Certification; Tomato Lycopene Extract and Tomato Lycopene Concentrate
The Food and Drug Administration (FDA) is responding to two objections that it received on the final rule that amended the color additive regulations authorizing the use of tomato lycopene extract and tomato lycopene concentrate as color additives in foods. After reviewing the objections to the final rule, the agency has concluded that the objections do not raise issues of material fact that justify a hearing or otherwise provide a basis for modifying the amendment to the regulation. FDA is also establishing a new effective date for this color additive regulation, which was stayed by the filing of proper objections.
Availability of Final Toxicological Profiles
This notice announces the availability of one new and seven updated final toxicological profiles of priority hazardous substances comprising the seventeenth set prepared by ATSDR.
Request for Nominations of Members to the Advisory Committee on Blood Safety and Availability
The Office of Public Health and Science (OPHS) is seeking nomination of qualified individuals to be considered for appointment as members on the Advisory Committee on Blood Safety and Availability (ACBSA). ACBSA is a Federal advisory committee in the Department of Health and Human Services. Management support for the activities of the Committee are the responsibility of OPHS. The qualified individuals will be nominated to the Secretary of Health and Human services for consideration of appointment as members of the ACBSA. Members of the Committee, including the Chair, are appointed by the Secretary. Members are invited to serve on the Committee for overlapping three-year terms.
Secretary's Advisory Committee on Human Research Protections
Pursuant to Section 10(a) of the Federal Advisory Committee Act, (U.S.C. Appendix 2), notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP), will hold its tenth meeting. The meeting will be open to the public.
Agency Information Collection Activities; Extension of Existing Collection; Comment Request; Title VI Program Performance Report
The Administration on Aging (AoA) 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 Title VI Program Performance Report.
Administration on Developmental Disabilities; Help America Vote Act (HAVA) Training and Technical Assistance (T/TA) To Assist Protection and Advocacy Systems (P&As) To Establish or Improve Voting Access for Individuals With Disabilities
The Administration on Developmental Disabilities (ADD) in the Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), announces the availability of Fiscal Year (FY) 2006 funds for the Help America Vote Act (HAVA) Training and Technical Assistance (T/TA) for Protection and Advocacy Systems (P&As). The purpose of funds awarded under this announcement is to provide T/TA to P&As in their promotion of full participation in the electoral process for individuals with disabilities, including registering to vote, casting a vote, and accessing polling places; developing proficiency in the use of voting systems and technologies as they affect individuals with disabilities (including blindness) in order to assess the availability and use of such systems and technologies for such individuals. At least one recipient of these funds must provide T/ TA for non-visual access.
National Institute of Environmental Health Sciences; Proposed Collection; Comment Request; The Sister Study: A Prospective Study of the Genetic and Environmental Risk Factors for Breast Cancer
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 Institute of Environmental Health Sciences (NIEHS), 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: The Sister Study: A Prospective Study of the Genetic and Environmental Risk Factors for Breast Cancer. Type of Information Collection Request: Revision of OMB No. 0925-0522 and expiration date 31 July 2006. Need and Use of Information Collection: The purpose of the Sister Study is to study genetic and environmental risk factors for the development of breast cancer in a cohort of sisters of women who have had breast cancer. In the United States, there were approximately 210,000 new cases in 2003, accounting for 30% of all new cancer cases among women. The etiology of breast cancer is complex, with both genetic and environmental factors likely playing a role. Environmental risk factors, however, have been difficult to identify. By focusing on genetically susceptible subgroups, more precise estimates of the contribution of environmental and other non-genetic factors to disease risk may be possible. Sisters of women with breast cancer are one group at increased risk for breast cancer; we would expect about 2 times as many breast cancers to accrue in a cohort of sisters as would accrue in a cohort identified through random sampling or other means. In addition, a cohort of sisters will be enriched with regard to the prevalence of relevant genes and/or exposures, further enhancing the ability to detect gene-environment interactions. Sisters of women with breast cancer will also be at increased risk for ovarian cancer and possibly for other hormonally-mediated diseases. We are enrolling a cohort of 50,000 women who have not had breast cancer. Initial recruitment of the first 2,000 women took place from August 2003- September 2004 before beginning nationwide recruitment in October 2004. The data collected in the initial phase allowed us to evaluate subject recruitment and data collection procedures, and helped us better target our recruitment efforts. We estimate that a cohort of 50,000 sisters aged 35-74 years would provide about 1,500 breast cancer cases over five years (approximately 300 new cases per year once the cohort is fully enrolled). Frequency of Response: At enrollment, one initial 15- minute screening (either on the telephone OR on the internet), 2 one- hour telephone interviews, 3 mailed self-administered questionnaires (90 minutes total), and some biological and household specimens collected. Women are advised that they will be contacted every year to update contact information and health status and asked to complete shorter (45-60 minutes, total) follow-up interviews or questionnaires every two years. Women diagnosed with breast cancer or other health outcomes of interest will be asked to provide additional information about their diagnosis (20 minutes per response) and their doctors will be contacted to provide documentation regarding diagnosis and treatments (15 minutes per response). Affected Public: Individuals or households; doctors' offices. Type of Respondents: Unaffected sisters of women diagnosed with breast cancer, aged 35-74, from all socioeconomic backgrounds and ethnicities. The annual reporting burden is as follows: Estimated Number of Respondents: 67,500 (~12,500 enrolled per year over ~4 years, plus ~14,000 persons ultimately determined ineligibles or refusals at initial screening, and 3,500 persons who partially complete enrollment before terminating). Estimated Number of Responses per Respondent: See table below. Average Burden Hours per Response: 6.0; and Estimated Total Burden Hours Requested: 176,553 (over 3 years). The average annual burden hours requested is 58,851. The annualized cost to respondents is estimated at $135 (assuming $20 hourly wage x 6 hours + $15 babysitting estimate). There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.
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