Department of Health and Human Services February 2006 – Federal Register Recent Federal Regulation Documents

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 Center for Complementary and Alternative Medicine (NCCAM), at 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: NCCAM Customer Service Data Collection. Type of Information Collection Request: Renewal. Need and Use of Information Collection: NCCAM provides the public, patients, families, health care providers, complementary and alternative medicine (CAM) practitioners, and others with the latest scientifically based information on CAM and information about NCCAM's programs through a variety of channels, including its toll-free telephone information service and its quarterly newsletter. To ensure that NCCAM is effectively serving all audiences, NCCAM needs to continue to measure customer satisfaction with NCCAM telephone interactions and the NCCAM newsletter and to assess which audiences are being reached through these channels. This effort involves a telephone survey consisting of 10 questions, which are asked of 25 percent of all callers, for an annual total of approximately 1,210 respondents; a print newsletter survey consisting of 10 questions, which is sent to all print newsletter subscribers, for an annual total of approximately 339 respondents; and an online newsletter survey consisting of 14 questions, which all visitors to the newsletter page on the NCCAM Web site have the option of completing until an annual total of 500 responses are received. NCCAM uses the data collected from the surveys to characterize NCCAM users and help program staff measure user satisfaction, assess impact of their communication efforts, tailor services to the public and health care providers, measure service use among special populations, and assess the most effective media and messages to reach these audiences. Frequency of Response: Once for the telephone survey, and three times for the newsletter survey (once every year to measure any changes in customer satisfaction and/or audience profile). Affected Public: Individuals and households. Type of Respondents: For the telephone survey, patients, spouses/family/friends of patients, health care providers, physicians, CAM practitioners, or other individuals contacting the NCCAM Clearinghouse; for the print newsletter survey, subscribers to the print NCCAM newsletter; and for the online newsletter survey, visitors to the newsletter page on NCCAM's Web site. The annual reporting burden is as follows.

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.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive worldwide license to practice the invention embodied in: E-171-2002, ``Cell Culturing and Storage Systems, Devices and Methods'' U.S. Patent Application 10/334,565 filed December 30, 2002; European Patent Application 03808601.3; rights are also pending in Canada and Australia; to KW Company, LLC, a New York company having its headquarters in Woodstock, New York. The United States of America is the assignee of the patent rights of the above invention. The contemplated exclusive license may be granted in the field of sales of devices for cell culturing, monitoring and containment.

The Food and Drug Administration (FDA) is canceling the meeting on the Animal Drug User Fee Act scheduled for February 24, 2006. This meeting was announced in the Federal Register of December 28, 2005 (70 FR 76851). FDA will continue to seek public comments relative to the program's overall performance and reauthorization as directed by Congress. FDA will publish another notice in the Federal Register announcing any plans for rescheduling the public meeting.

This notice announces the third meeting of the American Health Information Community Biosurveillance Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.)

This notice announces the third meeting of the American Health Information Community Electronic Health Record Workgroup in accordance with the Federal Adivsory Committee Act (Pub. L. 92-463, 5 U.S.C., App.)

NIOSH intends to review and evaluate toxicity data for the halogenated anesthetic agents of isoflurane, desflurane, and sevoflurane. The current NIOSH recommended exposure limit (REL) of 2 parts per million (ppm) as a 60-minute ceiling for the halogenated gases (chloroform, trichloroethylene, halothane, methoxyflurane, fluroxene, and enflurane) was established in 1977 [NIOSH 1977]. The halogenated anesthetic agents, isoflurane, desflurane, and sevoflurane, were subsequently introduced and are not included in the 1977 NIOSH recommendation. Isoflurane, desflurane, and sevoflurane are commonly used for anesthesia in modern hospitals; however, no occupational exposure limits exist for these agents. NIOSH is requesting: (1) Comments and information relevant to the evaluation of health risks associated with occupational exposure to isoflurane, desflurane, and sevoflurane, (2) reports or other data that demonstrate adverse health effects in workers exposed to isoflurane, desflurane, and sevoflurane, and (3) information pertinent to establishing a REL for isoflurane, desflurane, and sevoflurane.

The Food and Drug Administration (FDA) has determined the regulatory review period for ERBITUX and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human biological product.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (171) entitled ``Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles.'' This guidance describes the procedures that the agency recommends for the review of requests for waiver of in vivo demonstration of bioequivalence for generic soluble powder oral dosage form products and Type A medicated articles.

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 document entitled ``Guidance for Industry and FDA Staff: Whole Grain Label Statements.'' The draft guidance is intended to provide guidance to industry about what the agency considers to be ``whole grain'' and to assist manufacturers in labeling their products.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by PR Pharmaceuticals, Inc. The supplemental NADA provides for subcutaneous injection, in the ear only, of a suspension implant of estradiol benzoate microspheres for increased rate of weight gain in suckling beef calves. It also adds the indication for use for increased rate of weight gain in steers fed in confinement for slaughter, previously approved at a lower dose, to the higher approved dose level.

Notice is hereby given that on January 13, 2006, the Department of Health and Human Services (HHS) Debarring Official, on behalf of the Secretary of HHS, issued a final notice of debarment based on the research misconduct findings of the U.S. Public Health Service (PHS) in the following case: April Swe, University of Wisconsin-Madison: Based on the report of an investigation conducted by the University of Wisconsin-Madison (UWM) and additional analysis conducted by the Office of Research Integrity (ORI) in its oversight review, PHS found that Ms. Swe, former graduate student at UWM, engaged in research misconduct by fabricating data on thirty-nine (39) questionnaires of sibling human subjects associated with an autism study. The research was supported by National Institute on Aging, National Institutes of Health (NIH), grant R01 AG08768. In a final decision dated January 13, 2006, the HHS Debarring Official, on behalf of the Secretary of HHS, issued the final debarment notice based on the PHS findings of research misconduct. The following administrative actions have been implemented for a period of three (3) years, beginning on January 13, 2006: (1) Ms. Swe has been debarred from eligibility for or involvement as a principal in nonprocurement transactions (e.g., grants and cooperative agreements) of the Federal Government and from contracting or subcontracting with any Federal Government agency, except as provided in 45 CFR 76.120. This action is being taken pursuant to the debarment regulations at 45 CFR part 76. (2) Ms. Swe has been prohibited from serving in any advisory capacity to PHS including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as consultant.

The Secretary of Health and Human Services is adopting rules for the imposition of civil money penalties on entities that violate rules adopted by the Secretary to implement the Administrative Simplification provisions of the Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (HIPAA). The final rule amends the existing rules relating to the investigation of noncompliance to make them apply to all of the HIPAA Administrative Simplification rules, rather than exclusively to the privacy standards. It also amends the existing rules relating to the process for imposition of civil money penalties. Among other matters, the final rule clarifies and elaborates upon the investigation process, bases for liability, determination of the penalty amount, grounds for waiver, conduct of the hearing, and the appeal process.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Nonclinical Safety Evaluation of Pediatric Drug Products.'' This document provides guidance on the role and timing of animal studies in the nonclinical safety evaluation of therapeutics intended for the treatment of pediatric patients. The guidance discusses some conditions under which juvenile animals can be meaningful predictors of toxicity in pediatric patients and makes recommendations on nonclinical testing.

The Food and Drug Administration (FDA) is announcing that ARCH Chemicals, Inc., has filed a petition proposing that the food additive regulations be amended to provide for the safe use of poly (iminoimidocarbonyliminoimido- carbonyliminohexamethylene) hydrochloride (CAS Reg. No. 32289-58-0) as an antimicrobial agent in the manufacture of food-contact paper and paperboard.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and FDA staff entitled ``Class II Special Controls Guidance Document: Bone Sonometers.'' The draft guidance was developed to support the reclassification of bone sonometers from class III (premarket approval) into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to reclassify these devices accordingly. This draft guidance is neither final nor is it in effect at this time.

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 Fogarty International Center, 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.

The Food and Drug Administration (FDA), on behalf of the Centers for Disease Control and Prevention (CDC) and the National Institute of Allergy and Infectious Diseases (NIAID) are announcing a public workshop entitled ``Emerging Clostridial Disease.'' This public workshop is intended to develop a draft research agenda to better understand the virulence, pathogenesis, host factors, and nonantimicrobial risk factors contributing to reports of morbidity and mortality associated with Clostridium sordellii (C. sordellii) and Clostridium difficile (C. difficile). Additionally, our goals are to identify research needs and priorities that will enable rapid progress as well as to develop and provide recommendations for detecting cases and conducting surveillance of diseases and organisms. DATES: The public workshop will be held on May 11, 2006, from 8:30 a.m. to 4:30 p.m. See section III of this document for information on how to register to attend or present at the workshop. You must register by close of business on April 15, 2006, to attend or participate. We are opening a docket to receive your written or electronic comments (see ADDRESSES). Written or electronic comments must be submitted to the docket by June 15, 2006.

The Conference Report (H.R. Rep. No. 109-337) accompanying the Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2006, indicates concurrence with the Senate report language regarding the recompetition of Healthy Start programs. Following the Senate Committee's recommendation in Senate Report 109-103, the Health Resources and Services Administration (HRSA) will give preference during the FY 2006 competition ``to current and former grantees with expiring or recently expired project periods. This should include grantees whose grant applications were approved but not funded during fiscal year 2005.''

The Food and Drug Administration (FDA) has determined that PEPTAVLON (pentagastrin) for subcutaneous injection, 0.25 milligrams (mg) per milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for pentagastrin for subcutaneous injection, 0.25 mg/mL.

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.