Department of Health and Human Services March 2007 – Federal Register Recent Federal Regulation Documents

The National Vaccine Program Office is hereby giving notice that, in conjunction with the National Institutes of Health, the Food and Drug Administration, the Centers for Disease Control and Prevention, and the Health Resources and Services Administration, is hosting a 2-day meeting titled: Vaccine Safety Evaluation: Post- marketing Surveillance. The meeting is open to the public.

The Food and Drug Administration (FDA) is reopening until May 14, 2007, the comment period for the proposed rule published in the Federal Register of January 12, 2007 (72 FR 1582). The proposed rule would prohibit the use of certain cattle material in, or in the manufacture (including processing) of, drugs, biologics, and medical devices intended for use in humans and human cells, tissues, and cellular and tissue-based products (HCT/Ps) (collectively, medical products for humans), and in drugs intended for use in ruminant animals (drugs for ruminants) and would also require new recordkeeping provisions for medical products for humans and drugs for ruminants that are manufactured from or otherwise contain material from cattle. The agency is reopening the comment period in response to a request for more time to enable industry to generate more information on products that might be affected by the rule.

This final rule establishes, for the first time, Medicare conditions of participation for heart, heart-lung, intestine, kidney, liver, lung, and pancreas transplant centers. This rule sets forth clear expectations for safe, high quality transplant service delivery in Medicare-participating facilities. In addition, in this rule we respond to public comments on the proposed rule.

In compliance with the provisions of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comments on proposed data collection projects, the National Institutes of Health (NIH), National Cancer Institute (NCI) 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) is issuing a final rule establishing that over-the-counter (OTC) laxative drug products in granular dosage form containing the bulk-forming psyllium ingredients (psyllium (hemicellulose), psyllium hydrophilic mucilloid, psyllium seed, psyllium seed (blond), psyllium seed husks, plantago ovata husks, and plantago seed) are not generally recognized as safe and effective (GRASE) and are misbranded. This final rule includes, but is not limited to, any granules that are swallowed dry prior to drinking liquid; dispersed, suspended, or partially dissolved in liquid prior to swallowing; chewed, partially chewed, or unchewed, and then washed down (or swallowed) with liquid; or sprinkled over food. FDA is issuing this final rule after considering reports of esophageal obstruction associated with the use of psyllium laxatives in granular dosage form. These cases continue to occur despite efforts to promote safe use through label warnings and directions. This final rule does not apply to psyllium laxatives in nongranular dosage forms, such as powders, tablets, or wafers. This final rule is part of FDA's ongoing review of OTC drug products.

The Food and Drug Administration (FDA) has determined the regulatory review period for RETEVASE 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.

This notice announces the 15th meeting of the American Health Information Community Electronic Health Records Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).

This notice announces the 14th meeting of the American Health Information Community Chronic Care Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).

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 National Institutes of Health (NIH) is providing notice of the ``Priority List of Drugs for Which Pediatric Studies Are Needed.'' The NIH develops the list in consultation with the Food and Drug Administration (FDA) and pediatric experts, as mandated by the Best Pharmaceuticals for Children Act. This list prioritizes certain drugs that are most in need of study for use by children to ensure their safety and efficacy. The NIH will update the list at least annually until the Act expires on October 1, 2007.

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.

The Food and Drug Administration (FDA) has determined the regulatory review period for INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of two applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that medical device.

The Food and Drug Administration (FDA) Chicago District, in cooperation with the Society of Clinical Research Associates (SoCRA), is announcing a workshop on FDA clinical trial statutory and regulatory requirements. This 2-day workshop for the clinical research community targets sponsors, monitors, clinical investigators, institutional review boards, and those who interact with them for the purpose of conducting FDA-regulated clinical research. The workshop will include both industry and FDA perspectives on proper conduct of clinical trials regulated by FDA. Date and Time: The public workshop is scheduled for May 16, 2007, from 8:30 a.m. to 5 p.m. and May 17, 2007, from 8:30 a.m. to 4:30 p.m. Location: The public workshop will be held at the Oak Brook Hills Marriott Resort, 3500 Midwest Rd., Oak Brook, IL 60523, 630-850-5555, FAX: 630-850-5569. Contact: Marie Falcone, Food and Drug Administration, U.S. Customhouse, 200 Chestnut St., rm. 900, Philadelphia, PA 19106, 215- 717-3703, FAX: 215-597-5798, e-mail: marie.falcone@fda.hhs.gov. Registration: Send registration information (including name, title, firm name, address, telephone, and fax number) and the registration fee of $575 (member), $650 (nonmember), or $525 (Federal Government employee nonmember). (Registration fee for nonmembers includes a 1-year membership.) The registration fee for FDA employees is waived. Make the registration fee payable to SoCRA, 530 West Butler Ave., suite 109, Chalfont, PA, 18914. To register via the Internet go to www.socra.org (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register). The registrar will also accept payment by major credit cards. For more information on the meeting, or for questions on registration, contact 800-SoCRA92 (800-762-7292), or 215-822-8644, or via e-mail: socramail@aol.com. Attendees are responsible for their own accommodations. To make reservations at the Oak Brook Hills Marriott Resort, at the reduced conference rate, contact the Oak Brook Hills Marriott Resort (see Location) before April 24, 2007, citing meeting code SCRSCRA. The registration fee will be used to offset the expenses of hosting the conference, including meals, refreshments, meeting rooms, and materials. Space is limited, therefore interested parties are encouraged to register early. Limited onsite registration may be available. Please arrive early to ensure prompt registration. If you need special accommodations due to a disability, please contact Marie Falcone (see Contact) at least 7 days in advance of the workshop.

Pursuant to section 814 of the Native American Programs Act of 1974 (the Act) 42 U.S.C. 2992b-1, ANA herein describes its proposed interpretive rules, statements of general policy and rules of agency procedure or practice in relation to the Social and Economic Development Strategies (hereinafter referred to as SEDS), Native Language Preservation and Maintenance (hereinafter referred to as Native Language), Environmental Regulatory Enhancement (hereinafter referred to as Environmental), Environmental Mitigation (hereinafter referred to as Mitigation), Improving the Well-Being of Children Native American Healthy Marriage Initiative (hereinafter referred to as Healthy Marriage) programs and any Special Initiatives. Under the statute, ANA is required to provide members of the public an opportunity to comment on proposed changes in interpretive rules, statements of general policy and rules of agency procedure or practice and to give notice of the final adoption of such changes at least thirty (30) days before the changes become effective. This Notice also provides additional information about ANA's plan for administering the programs. On July 18, 2005, ANA published a Notice of Public Comment (NOPC) in the Federal Register (Vol. 70, No. 136) announcing an administrative policy change on the number of awards an eligible applicant could receive under the SEDS program, Catalog of Federal Domestic Assistance number 93.612. This change only affected the Healthy Marriage program. On November 21, 2006, ANA published the annual NOPC in the Federal Register (Vol. 71, No. 224), which did not include a necessary correction to the revised administrative policy published on July 18, 2005. On December 22, 2006, ANA published a third Federal Register notice (Vol. 71, No. 246) to clarify the revised administrative policy published on July 18, 2005, on the number of awards an eligible applicant could receive under the SEDS program, Catalog of Federal Domestic Assistance number 93.612. ANA received three responses to the December 22, 2006, NOPC clarification. After review and consideration of the comments received, ANA determined that the administrative policy originally published on July 18, 2005, required clarification and revision. This Notice clarifies the agency's intent and provides a definitive statement on the number of awards an eligible applicant can receive under the Catalog of Federal Domestic Assistance number 93.612.

The Food and Drug Administration (FDA) has determined the regulatory review period for A180 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 animal drug product.

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) has determined the regulatory review period for EMTRIVA 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 drug product.

The Food and Drug Administration (FDA) has determined the regulatory review period for ONYX LES 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 medical device.

The Food and Drug Administration (FDA) has determined the regulatory review period for REVLIMID 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 drug product.

The Food and Drug Administration (FDA) has determined that DURICEF (cefadroxil USP) Tablets, 1 gram (g), and Capsules, 500 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to continue to approve abbreviated new drug applications (ANDAs) for cefadroxil USP tablets, 1 g, and cefadroxil USP capsules, 500 mg.

This notice announces the sixth meeting of the Emergency Medical Treatment and Labor Act (EMTALA) Technical Advisory Group (TAG). The purpose of the EMTALA TAG is to review regulations affecting hospital and physician responsibilities under EMTALA to individuals who come to a hospital seeking examination or treatment for medical conditions. The primary purpose of the sixth meeting is to enable the EMTALA TAG to hear additional testimony and further consider written responses from medical societies and other organizations on specific issues considered by the EMTALA TAG at previous meetings. The public is permitted to attend this meeting and, to the extent that time permits and at the discretion of the Chairperson, the EMTALA TAG may hear comments from the floor.

This notice invites nominations of members to the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel). There will be two vacancies on the Panel as of October 1, 2007. Consequently, this solicitation is for two new members. The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary, DHHS, (the Secretary) and the Administrator, CMS, (the Administrator) concerning the clinical integrity of the APC groups and their associated weights. We consider the Panel's advice as CMS prepares its annual updates of the hospital Outpatient Prospective Payment System (OPPS). The Secretary rechartered the Panel in 2006 for a 2-year period effective through November 21, 2008. Nominations: We will consider nominations if they are received no later than 5 p.m. on May 30, 2007. Please mail or hand deliver nominations to the following address: CMS; Attn: Shirl Ackerman-Ross, Designated Federal Official (DFO), Advisory Panel on APC Groups; Center for Medicare Management, Hospital & Ambulatory Policy Group, Division of Outpatient Care; 7500 Security Boulevard, Mail Stop C4-05-17; Baltimore, MD 21244-1850. Web site: For additional information on the APC Panel and updates to the Panel's activities, search our Web site at the following: http:/ /www.cms.hhs.gov/FACA/05AdvisoryPanelonAmbulatory PaymentClassificationGroups.asp#TopOfPage. E-Mail Address: The E-mail address for the Panel is as follows: CMSAPCPanel@cms.hhs.gov. News media representatives must contact our Public Affairs Office at (202) 690-6145. Advisory Committees' Information Lines: The CMS Advisory Committees' Information Line is 1-877-449-5659 (toll free) and (410) 786-9379 (local).

This notice announces the extension of the expiration date for certain geographic reclassifications as implemented by Division B, Title I, section 106 of the Tax Relief and Health Care Act of 2006. These geographic classifications, which affected hospitals' wage indices, were previously set to expire on March 31, 2007 and are now extended to September 30, 2007.

This document corrects wage index values and a relative weighting factor error that appeared in the correction notice published in the Federal Register on January 5, 2007 entitled ``Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2007 Rates; Final Fiscal Year 2007 Wage Indices and Payment Rates After Application of Revised Occupational Mix Adjustment to Wage Index; Corrections''.

This notice announces the continuation of effectiveness of a Medicare interim final rule and the extension of the timeline for publication of the final rule. This notice is issued in accordance with section 1871(a)(3)(C) of the Social Security Act (the Act), which allows an interim final rule to remain in effect after the expiration of the timeline specified in section 1871(a)(3)(B) of the Act if the Secretary publishes a notice of continuation prior to the expiration of the timeline.

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 United States faces serious public health threats from the deliberate use of weapons of mass destruction (WMD)chemical, biological, radiological, or nuclear (CBRN)by hostile States or terrorists, and from naturally emerging infectious diseases that have a potential to cause illness on a scale that could adversely impact national security. Effective strategies to prevent, mitigate, and treat the consequences of CBRN threats is an integral component of our national security strategy. To that end, the United States must be able to rapidly develop, stockpile, and deploy effective medical countermeasures to protect the American people. This HHS Public Health Emergency Medical Countermeasures Enterprise Strategy (HHS PHEMCE Strategy) establishes the goals and objectives that HHS will employ to ensure that medical countermeasures are available for effective use against the highest priority CBRN threats facing the Nation. The HHS PHEMCE Strategy considers the full spectrum of medical countermeasures- related activities, including research, development, acquisition, storage/maintenance, deployment, and utilization. The HHS PHEMCE Strategy is consistent with the President's Biodefense for the 21st Century and aligned with the National Strategy for Medical Countermeasures against Weapons of Mass Destruction.

This notice announces those sites for which ATSDR has completed public health assessments and health consultations during the period from October 1, 2006, through December 31, 2006. This list includes sites that are on or proposed for inclusion on the National Priorities List (NPL) and includes sites for which assessments or consultations were prepared in response to requests from the public.

The National Institute for Occupational Safety and Health (NIOSH) announces the following availability of opportunity for the public to provide input regarding the draft document, ``Long-Term Field Evaluation (LTFE) Program Concept.'' NIOSH is the Federal agency responsible for conducting research and making recommendations for the approval for self-contained, self- rescuer (SCSR) closed circuit escape respirators, Title 42, Code of Federal Regulations (CFR), Part 84. The LTFE program for self-contained self-rescuers (SCSRs) for miners was initiated more than 20 years ago by the U.S. Bureau of Mines. The objective for the LTFE program is to obtain data to determine the expected performance characteristics of SCSRs used in the mining industry. LTFE program results based on scientific principles can provide useful information to monitor expected SCSR performance and assess possible degradation due to the physical stresses of in-mine use. Of utmost concern is the successful performance of any SCSR that passes its inspection criteria specified by the manufacturer. It is such apparatus that must be relied upon in an emergency. A copy of the draft document can be found at https://www.cdc.gov/ niosh/review/public/NPPTL-LTFE/.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to modify a SOR titled, ``Long Term Care-Minimum Data Set'' (MDS), System No. 09-70-1517, most recently modified at 67 FR 6714 (February 13, 2002). We propose to assign a new CMS identification number to this system to simplify the obsolete and confusing numbering system originally designed to identify the Bureau, Office, or Center that maintained information in the Health Care Financing Administration systems of records. The new identifying number for this system should read: System No. 09-70-0528. We propose to modify existing routine use number 1 that permits disclosure to agency contractors and consultants to include disclosure to CMS grantees who perform a task for the agency. CMS grantees, charged with completing projects or activities that require CMS data to carry out that activity, are classified separate from CMS contractors and/or consultants. The modified routine use will remain as routine use number 1. We also propose to modify existing routine use number 3 that permits disclosure to Peer Review Organizations (PRO). The name of PROs has been changed to read: ``Quality Improvement Organizations (QIO).'' QIOs will continue work to implement quality improvement programs, provide consultation to CMS, its contractors, and to state agencies. The modified routine use will remain as routine use number 3. We will delete routine use number 6 authorizing disclosure to support constituent requests made to a congressional representative. If an authorization for the disclosure has been obtained from the data subject, then no routine use is needed. The Privacy Act allows for disclosures with the ``prior written consent'' of the data subject. We are modifying the language in the remaining routine uses to provide a proper explanation as to the need for the routine use and to provide clarity to CMS's 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 that were affected by the recent reorganization or because of the impact of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) provisions and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of the system is to aid in the administration of the survey and certification, and payment of Medicare Long Term Care services, which include skilled nursing facilities (SNFs), nursing facilities (NFs) SNFs/NFs, and hospital swing beds, and to study the effectiveness and quality of care given in those facilities. Information in this system will also be used to: (1) Support regulatory, reimbursement, and policy functions performed within the Agency or by a contractor or consultant; (2) assist another Federal or state agency, agency of a state government, an agency established by state law, or its fiscal agent; (3) support Quality Improvement Organizations (QIO); (4) assist other insurers for processing individual insurance claims; (5) facilitate research on the quality and effectiveness of care provided, as well as payment related projects; (6) support litigation involving the Agency; (7) assist national accrediting organizations; and (8) combat fraud, waste, and abuse in certain health benefits programs. We have provided background information about the modified system in the SUPPLEMENTARY INFORMATION section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See ``Effective Dates'' section for comment period.

The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at the Allied Chemical Corporation Plant in Metropolis, Illinois, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On February 1, 2007, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

AHRQ invites nominations of topics for evidence reports, technology assessments, and comparative and effectiveness reviews conducted by its Evidence-based Practice Centers (EPC) Program relating to the prevention, diagnosis, treatment and management of common diseases and clinical condition, as well as, topics relating to the organization and financing of health care. Previous evidence reports and comparative effectiveness reviews can be found at https:// www.ahrq.gov/clinic/epcix.htm and https://effective healthcare.ahrq.gov/ products/progress.cfm, respectively.

The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved by the Center for Biologics Evaluation and Research (CBER). This list is intended to inform the public of the availability through the Internet and the FDA's Division of Dockets Management of summaries of safety and effectiveness data of approved PMAs.

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 PRA).

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material from Cattle'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests.'' This guidance describes some statistically appropriate practices for reporting results from different studies evaluating diagnostic tests and identifies some common inappropriate practices. Special attention is given to describing a practice called discrepant resolution and its associated problems.

The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) in the Food and Drug Administration (FDA) are seeking sponsors interested in participating in a pilot project to test the submission of case report form (CRF) data provided electronically in extensible markup language (XML) based on the Operational Data Model (ODM) developed by the Clinical Data Interchange Standards Consortium (CDISC). This pilot will test the ability of a new data format to support all review activity, which our current submission format is incapable of doing. Data supplied in ODM format by sponsors during the pilot project will not replace any regulatory requirements for submitting CRFs. We anticipate that a successful pilot will allow CDER and CBER to routinely accept CRFs from studies employing electronic data capture (EDC) in ODM format in marketing applications provided in electronic format.