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

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.

The Food and Drug Administration (FDA) is announcing the availability of a compliance guidance for small business entities entitled ``Labeling OTC Human Drug Products; Small Entity Compliance Guide.'' FDA has prepared this guidance in accordance with the Small Business Regulatory Enforcement Fairness Act. It is intended to help small businesses better understand and comply with the agency's over- the-counter (OTC) labeling requirements and to prepare new labeling. This compliance guidance finalizes the draft compliance guidance published on December 9, 2004.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Health Literacy Item Set Supplemental to CAHPS Hospital SurveyPretest of Proposed Questions and Methodology.'' 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.

Authorized by the American Recovery and Reinvestment Act of 2009 (ARRA), the Federal Coordinating Council for Comparative Effectiveness Research will help coordinate research and guide investments in comparative effectiveness research funded by the Recovery Act. The Coordinating Council is holding this meeting to hear from the public about their views on the Council's activities.

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 amending the animal drug regulations to reflect the original approval of an abbreviated new animal drug application (ANADA) filed by Norbrook Laboratories, Ltd. The ANADA provides for the veterinary prescription use of carprofen caplets in dogs.

HHS gives notice concerning the final effect of the HHS decision to designate a class of employees at Tyson Valley Powder Farm near Eureka, Missouri, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On March 31, 2009, 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:

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

On behalf of the Department of Health and Human Services (HHS) and the Public Health Service (PHS), a component of the HHS, the National Institutes of Health (NIH) seeks comments from the public on whether the HHS should amend its regulations on the responsibility of applicants for promoting objectivity in research for which phs funding is sought and on responsible prospective. We are interested particularly in receiving comments on the issues presented below from the general public, individual Investigators, scientific societies and associations, Members of Congress, other Federal agencies that support or conduct research, and institutions that receive PHS funds to conduct or support biomedical or behavioral research.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public. Pre-registration is required for both public attendance and comment. Individuals who wish to attend the meeting and/or participate in the public comment session should either e-mail nvpo@hhs.gov or call 202-690-5566 to register.

The Food and Drug Administration (FDA) is announcing the opening of a docket to receive and to make available to the public reports and other relevant information received by FDA related to the Sentinel Initiative. The goal of the Sentinel Initiative is to develop a system that will ultimately enable FDA to actively monitor the safety of marketed regulated products. The information that will be made available is being developed primarily, but not exclusively, as a result of a series of contracts awarded by FDA to inform the development of the system. The information will be made available in the docket under the docket number at the top of this notice, as well as on FDA's Sentinel Initiative Web page (Sentinel Web page) at https:// www.fda.gov/oc/initiatives/advance/sentinel/. FDA welcomes interested parties, including individuals, to submit to this docket their views and perspectives on the information included in the docket or on any other aspect of the Sentinel Initiative.

This notice announces the first meeting of the HIT Standards Committee in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR404.7(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. 5,167,956 and PCT Application Serial No. PCT/US92/00813 and foreign equivalents thereof, entitled ``Immunotoxin with in vivo T cell suppressant activity and methods of use'' (HHS Ref. No. E-012-1991/0); U.S. Patent No. 5,725,857 and foreign equivalents thereof, entitled ``Immunotoxin with in vivo T cell suppressant activity and methods of use'' (HHS Ref. No. E-012-1991/2); U.S. Patent No. 5,762,927 and foreign equivalents thereof, entitled ``Immunotoxin with in vivo T cell suppressant activity and methods of use'' (HHS Ref. No. E-012-1991/4); Australian Patent No. 762197 and PCT Application Serial No. PCT/US96/ 05087 and other foreign equivalents thereof, entitled ``Methods of inducing immune tolerance using immunotoxins'' (HHS Ref. No. E-012- 1991/5); U.S. Patent No. 6,103,235 and foreign equivalents thereof and U.S. Patent No. 7,125,553 and foreign equivalents thereof, entitled ``Methods of inducing immune tolerance using immunotoxins'' (HHS Ref. No. E-012-1991/7); Australian Patent No. 766692 entitled ``Novel vectors and expression methods for producing mutant proteins'' (HHS Ref. No. E-043-1997/0); U.S. Patent Application No. 10/566,886 and PCT Application No. PCT/US2004/24786 and foreign equivalents thereof entitled ``Methods for expression and purification of immunotoxins'' (E-043-1997/2); U.S. Patent No. 6,632,928 and PCT Application Serial No. PCT/US98/04303 and foreign equivalents thereof, entitled ``Novel immunotoxins and methods of inducing immune tolerance'' (HHS Ref. No. E-044-1997/0); U.S. Patent Application No. 10/296,085 and PCT Application Serial No. PCT/US01/16125 and foreign equivalents thereof entitled ``Immunotoxin Fusion Proteins and Means for Expression Thereof'' (HHS Ref. No. E-044-1997/1); U.S. Patent No. 7,288,254 and PCT Application Serial No. PCT/US99/08606 and foreign equivalents thereof entitled ``Use of immunotoxins to induce immune tolerance to pancreatic islet transplantation'' (HHS Ref. No. E-059-1998/0); Australian Patent No. 781547 and PCT Application No. PCT/US00/10253 and other foreign equivalents thereof, entitled ``Methods related to combined use of immunotoxins and agents that inhibit dendritic cell maturation'' (HHS Ref. No. E-168-1999/0), to Angimmune LLC which is located in Bethesda, Maryland. The patent rights in these inventions have been assigned to the United States of America.

This proposed rule would delay enforcement of certain portions of the final rule entitled ``Medicaid Program; Health Care-Related Taxes'' from the expiration of a Congressional moratorium on enforcement on July 1, 2009 until June 30, 2010. That final rule revised the threshold levels under the regulatory indirect guarantee hold harmless arrangement test to reflect the provisions of the Tax Relief and Health Care Act of 2006, amended the definition of the ``class of managed care organization services,'' and removed obsolete transition period regulatory language. These changes would not be affected by this delay of enforcement. The final rule also clarified the standard for determining the existence of a hold harmless arrangement under the positive correlation test, Medicaid payment test, and the guarantee test. This proposed rule would delay enforcement of these latter provisions, concerning hold harmless arrangements, for 1 year.

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 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 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 notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Medical Expenditure Panel Survey (MEPS) Household Component and the MEPS Medical Provider Component Through 2012.'' 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.

The Administration on Aging (AoA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The National Institutes of Health (NIH), an operating division of the Department of Health and Human Services (HHS), has decided, after completion of a Final Environmental Impact Statement (FEIS) and a thorough consideration of the public comments on the Draft EIS and the Final EIS, to implement the Proposed Action, which is identified as the Preferred Alternative in the FEIS. This action involves the establishment of a long-range physical Master Plan for Rocky Mountain Laboratories (RML) in Hamilton, Montana to guide future development of the campus. This alternative accounts for potential growth in RML personnel, possible land acquisitions, and consequent construction of new administrative and research-related space over the 20-year planning period.

The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (``the Program''), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

The Food and Drug Administration (FDA) is proposing to amend the biologics regulations to clarify the regulatory procedures for notifying the public about the revocation of a biologics license to be consistent with current practices. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register.

The Food and Drug Administration (FDA) is correcting a final rule; confirmation of effective date, that appeared in the Federal Register of Friday, April 24, 2009 (74 FR 18626) (the April 24, 2009, final rule; confirmation of effective date). That document had confirmed the effective date of April 27, 2009, for a final rule that published in the Federal Register of April 25, 2008 (73 FR 22720), entitled ``Substances Prohibited From Use in Animal Food or Feed.'' In the April 24, 2009, final rule; confirmation of effective date, the agency also established a compliance date of October 26, 2009, in order to allow additional time for renderers to comply with the new requirements. The April 24, 2009, final rule; confirmation of effective date was published with an inadvertent error in the ``Background'' section. This document corrects that error.