Department of Health and Human Services May 2009 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is amending its bottled water regulations to require that bottled water manufacturers test source water for total coliform, as is required for finished bottled water products, and to require, if any coliform organisms are detected in source water, that bottled water manufacturers determine whether any of the coliform organisms are Escherichia coli (E. coli), an indicator of fecal contamination. FDA also is amending its bottled water regulations to require, if any coliform organisms are detected in finished bottled water products, that bottled water manufacturers determine whether any of the coliform organisms are E. coli. FDA also is amending the adulteration provision of the bottled water standard to reflect the possibility of adulteration caused by the presence of filth. Bottled water containing E. coli will be considered adulterated, and source water containing E. coli will not be considered to be of a safe, sanitary quality and will be prohibited from use in the production of bottled water. FDA is also amending its bottled water regulations to require that, before a bottler can use source water from a source that has tested positive for E. coli, the bottler must take appropriate measures to rectify or eliminate the cause of E. coli contamination of that source, and that the bottler must keep records of such actions. Existing regulatory provisions require bottled water manufacturers to keep records of new testing required by this rule. This final rule will ensure that FDA's standards for the minimum quality of bottled water, as affected by fecal contamination, will be no less protective of the public health than those set by the Environmental Protection Agency (EPA) for public drinking water.

Under the American Recovery and Reinvestment Act of 2009 (ARRA), additional funds are available to expand the National Health Service Corps (NHSC) through its programs to provide access to, and improve quality of, primary health care for millions of underserved Americans. The HRSA is therefore announcing an approximate 16-month funding cycle for new NHSC Loan Repayment applications and awards. During this 16-month cycle, the NHSC Loan Repayment Program will accept applications for loan repayment awards until all funds are expended. The policies described in this notice will be effective for all NHSC loan repayment awards made using ARRA funding from June 2009, to September 30, 2010, and all NHSC loan repayment awards made using fiscal year (FY) 2010 funding (if funding is appropriated) from October 1, 2009, to September 30, 2010. Provisions regarding assignment of NHSC Scholarship Program participants for the upcoming program year will be announced through a subsequent Notice.

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.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, 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 to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on March 9, 2009, pages 10057-10058 and allowed 60-days for public comment. No comments were received in response to this notice. 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.

Pursuant to Public Law 92-463, notice is hereby given of a meeting of the NTP Board of Scientific Counselors (BSC). The BSC is a federally chartered, external advisory group composed of scientists from the public and private sectors that provides primary scientific oversight to the NTP Director and evaluates the scientific merit of the NTP's intramural and collaborative programs.

This proposed notice acknowledges the receipt of a deeming application from the American Osteopathic Association (AOA) for continued recognition as a national accrediting organization for ambulatory surgical centers (ASCs) that wish to participate in the Medicare or Medicaid programs. The statute requires that we publish, within 60 days of receipt of an organization's complete application, a notice identifying the national accrediting body making the request, describing the nature of the request, and providing at least a 30-day public comment period.

The Food and Drug Administration (FDA) Minneapolis District, in cosponsorship with the Society of Clinical Research Associates, Inc. (SoCRA) is announcing a public workshop entitled ``FDA Clinical Trial Requirements.'' This 2-day public workshop is intended to provide information about FDA clinical trial requirements to the regulated industry.

This notice announces a meeting of the Advisory Panel on Medicare Education (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on opportunities to enhance the effectiveness of consumer education strategies concerning the Medicare program. This meeting is open to the public.

This notice announces a public meeting to receive comments and recommendations (and data on which recommendations are based) from the public on the appropriate basis for establishing payment amounts for a specified list of new Clinical Procedural Terminology (CPT) codes for clinical laboratory tests in calendar year (CY) 2010. The meeting provides a forum for interested parties to make oral presentations and submit written comments on the new codes that will be included in Medicare's Clinical Laboratory Fee Schedule for CY 2010, which will be effective on January 1, 2010. The development of the codes for clinical laboratory tests is largely performed by the CPT Editorial Panel and will not be further discussed at the Centers for Medicare & Medicaid Services (CMS) meeting.

In FY 2005, ORR awarded a competitive service grant for the Individual Development Account (IDA) Program grant to New York Association for New Americans, Inc. (NYANA) in New York, NY. The original project was from September 29, 2005, through September 30, 2010. NYANA served as the fiscal sponsor and legal entity of the approved project. As of February 1, 2009, NYANA has ceased operations of the Individual Development Account program. NYANA has requested ORR permission for the Center for Community Development for New Americans (CCDNA) to assume the grant. CCDNA has agreed to this request. The effect of this deviation request is to transfer the grant from the initial grantee to a new grantee with all the responsibilities of managing and implementing the project for the remainder of the grant period.

We are proposing to revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems, and to implement certain provisions made by the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA, Pub. L. 110-275) and the American Recovery and Reinvestment Act of 2009 (ARRA, Pub. L. 111-5). In addition, in the Addendum to this proposed rule, we describe the proposed changes to the amounts and factors used to determine the rates for Medicare acute care hospital inpatient services for operating costs and capital-related costs. These proposed changes would be applicable to discharges occurring on or after October 1, 2009. We also are setting forth the proposed update to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits. The proposed updated rate-of-increase limits would be effective for cost reporting periods beginning on or after October 1, 2009.

The Department of Health and Human Services (DHHS) is reopening the comment period until October 9, 2009 for the Notice of Proposed Rulemaking on Quality Assurance Requirements for Respirators that was published in the Federal Register on Wednesday, December 10, 2008 (73 FR 75045). The comment period previously closed on April 10, 2009.

The Department of Health and Human Services (DHHS) is reopening the comment period until June 19, 2009 concerning the proposed rule for Approval Tests and Standards for Closed-Circuit Escape Respirators that was published in the Federal Register on Wednesday, December 10, 2008 (73 FR 75027). The previous comment period closed on April 10, 2009.

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 that the Center for Devices and Radiological Health (CDRH) will be moving from various Rockville, Maryland locations to Building 66 at 10903 New Hampshire Avenue in Silver Spring, Maryland from approximately mid May 2009 until the beginning of August 2009. Offices will progressively move over weekends during this period. Specifically, moves will occur on Friday, Saturday, and Sunday except on holiday weekends. During the period required for relocation of files, equipment, and agency personnel, the Center for Devices and Radiological Health will not officially receive premarket submissions on the Friday of a move weekend and the Monday after a move weekend.

The Family and Youth Services Bureau (FYSB) awarded a Mentoring Children of Prisoners grant (Grant No. 90CV0343) to Prevent Child Abuse California of North Highlands, CA on September 30, 2007. On October 31, 2008, Prevent Child Abuse California submitted a letter relinquishing their grant. Amador Tuolumne Community Action Agency of Jackson, CA, an eligible non-profit organization, submitted their letter along with their grant application requesting approval as the replacement grantee for the Mentoring Children of Prisoners grant. FYSB has received and reviewed the application from Amador Tuolumne Community Action Agency. Upon finding that the proposed project will be able to carry out objectives originally intended to be completed by Prevent Child Abuse California, this organization has been awarded funds in the amount of $292,000 as the permanent successor grantee.

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 Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Patent No. 6,610,684 entitled, ``Fused Azepinone Cyclin Dependent Kinase Inhibitors'' and all foreign counterparts [HHS Ref. No. E-025- 1998/0] to ShanaRx Pharmaceuticals. The patent rights in this invention have been assigned to the United States of America.

The National Center for Complementary and Alternative Medicine (NCCAM) invites the research community to participate in an online Workshop on Non-Pharmacological Management of Back Pain. The purpose of this workshop is to identify and explore a range of important and timely clinical research questions related to non-pharmacological interventions to treat back pain. This information will help inform future research directions for NIH and the biomedical scientific field. This workshop will be split into three sessions that will feature presentations and discussions focusing on the current understanding and complexity of chronic back pain, promising questions associated with testable hypotheses, and the relevant outcome measures.

The meeting of the Gastrointestinal Drugs Advisory Committee scheduled for May 20, 2009, is cancelled. This meeting was announced in the Federal Register of April 7, 2009 (74 FR 15739). The FDA's Center for Drug Evaluation and Research is continuing to review the application that was going to be discussed by the committee.

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 Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644).

The Food and Drug Administration (FDA) is requesting nominations for voting consumer representatives to serve on the Food Advisory Committee. This advisory committee is under the purview of the Center for Food Safety and Applied Nutrition (CFSAN).

This notice sets forth the Secretary's decision to require Hospital Preparedness Program [HPP] cooperative agreement recipients to contribute non-Federal matching funds starting with the FY 2009 funding cycle and each year thereafter. The amount of the cost sharing requirement in FY 2009 will be five percent of the award amount and in FY 2010 and each year thereafter the amount of match will be ten percent of the award amount.

The Food and Drug Administration (FDA) is announcing the availability of a guidance document for industry (199) entitled ``Animal Generic Drug User Fees and Fee Waivers and Reductions.'' The purpose of this document is to provide guidance to industry on the Animal Generic Drug User Fee Act of 2008 (AGDUFA). FDA is issuing this final guidance document for immediate implementation consistent with the agency's good guidance practices (GGPs). Interested persons may submit comments on agency guidances at any time.