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

In compliance with the requirement of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Director (OD), the Office of Extramural Research, 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 February 27, 2009, Vol. 74, No. 38, page 8972 and allowed 60 days for public comment. No 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 September 30, 2011, unless it displays a currently valid OMB control number.

This notice updates the payment rates for the Medicare prospective payment system (PPS) for inpatient psychiatric hospital services provided by inpatient psychiatric facilities (IPFs). These changes are applicable to IPF discharges occurring during the rate year beginning July 1, 2009 through June 30, 2010. We are also requesting comments on the IPF PPS teaching adjustment and the market basket.

This notice announces the establishment of the Children's Health Insurance Program Working Group and discusses the group's purpose and charter. It also solicits nominations for members.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry 195 entitled ``Small Entities Compliance Guide for RenderersSubstances Prohibited From Use in Animal Food or Feed'' This small entities compliance guide aids renderers in complying with the requirements of the final rule published in the Federal Register of April 25, 2008 (73 FR 22720). FDA's goal is to strengthen existing safeguards to prevent the spread of bovine spongiform encephalopathy (BSE) in U.S. cattle and to reduce the risk of human exposure to the BSE agent.

The U.S. Department of Health and Human Services is hereby giving notice that the Working Group on Strengthening the Biosecurity of the United States will be holding a public consultation meeting. The meeting is open to the public.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Bottled Water: ArsenicSmall Entity Compliance Guide'' for a final rule published in the Federal Register of June 9, 2005. This small entity compliance guide (SECG) is intended to set forth in plain language the requirements of the regulation and to help small businesses understand the regulation.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Bottled Water: UraniumSmall Entity Compliance Guide'' for a direct final rule published in the Federal Register of March 3, 2003. This small entity compliance guide (SECG) is intended to set forth in plain language the requirements of the regulation and to help small businesses understand the regulation.

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 PCT Patent Application No. PCT/US02/18790, filed June 14, 2002, which published as WO 2004/001655 on December 31, 2003, now expired, entitled ``Method of Treating and Preventing Colitis Involving IL-13 and NK-T Cells'' [HHS Ref. No. E-131-2002/0-PCT-01];U.S. Patent Application No. 10/517,898, filed December 13, 2004, which was published as US-2006- 0024306 A1 on February 2, 2006, entitled ``A Method of Treating Inflammatory Bowel Disease (IBD)'' [HHS Ref. No. E-131-2002/0-US-02]; European Patent Application No. 02742057.9, filed June 14, 2002, which published as 1552462 on July 13, 2005, entitled ``Method of Treating and Preventing Colitis Involving IL-13 and NK-T Cells'' [HHS Ref. No. E-131-2002/0-EP-08]; Australian Patent Application No. 2002315115, filed June 14, 2002, entitled ``Method of Treating and Preventing Colitis Involving IL-13 and NK-T Cells'' [HHS Ref. No. E-131-2002/0-AU- 05]; Japanese Patent Application No. 2004515561, filed June 14, 2002, entitled ``Method of Treating and Preventing Colitis Involving IL-13 and NK-T Cells'' [HHS Ref. No. E-131-2002/0-JP-04]; New Zealand Patent Application No. 537726, filed June 14, 2002, entitled ``Method of Treating and Preventing Colitis Involving IL-13 and NK-T Cells'' [HHS Ref. No. E-131-2002/0-NZ-06]; Hong Kong Patent Application No. 05112119.6, filed June 14, 2002, entitled ``Method of Treating and Preventing Colitis Involving IL-13 and NK-T Cells'' [HHS Ref. No. E- 131-2002/0-HK-09]; South African Patent Application No. 2005/00375, filed June 14, 2002, entitled ``Method of Treating and Preventing Colitis Involving IL-13 and NK-T Cells'' [HHS Ref. No. E-131-2002/0-ZA- 07]; Canadian Patent Application No. 2489540, filed June 14, 2002, entitled ``Method of Treating and Preventing Colitis Involving IL-13 and NK-T Cells'' [HHS Ref. No. E-131-2002/0-CA-03]; U.S. Provisional Patent Application No. 60/671,624, filed April 15, 2005, now abandoned, entitled ``Treatment and prevention of IBD using Mutant and Chimeric IL-13 Molecules'' [HHS Ref. No. E-003-2005/0-US-01]; PCT Patent Application No. PCT/US06/014393, filed April 14, 2006, now expired, entitled ``Methods of Treating and Preventing Inflammatory Bowel Disease Involving IL-13 and NKT Cells,'' which published as WO 2006/ 113614 on October 20, 2006 [HHS Ref. No. E-003-2005/0-PCT-02]; European Patent Application No. 06750435.7, filed November 12, 2007, entitled ``Methods of Treating and Preventing Inflammatory Bowel Disease Involving IL-13 and NKT Cells,'' which published as 1877074 on January 16, 2008, [HHS Ref. No. E-003-2005/0-EP-04]; and U.S. Patent Application No. 11/918,711, filed April 14, 2006, entitled ``Treatment and Prevention of Inflammatory Bowel Disease (IBD) Using Mutant and Chimeric IL-13 Molecules'' [HHS Ref. No. E-003-2005/0-US-03] to Innate Immune, Inc. which has an office in Stanford, California, U.S.A. The patent rights in these inventions have been assigned to the United States of America and Brigham and Women's Hospital.

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 (HHS), is contemplating the grant of a an exclusive license to practice the following invention as embodied in the following patent applications: (1) E-120-2001/0, Whitehead et al., ``Development of Mutations Useful for Attenuating Dengue Viruses and Chimeric Dengue Viruses'', Brazilian Patent Application PI0209943.8, filed May 22, 2002, (2) E-089-2002/0,1, Whitehead et al., ``Dengue Tetravalent Vaccine Containing a Common 30 Nucleotide Deletion in the 3'-UTR of Dengue Types 1,2,3, and 4, or Antigenic Chimeric Dengue Viruses 1,2,3, and 4'', Brazilian Patent Application PI0309631-9, filed April 25, 2003, and (3) E-139-2006/0, Whitehead et al., ``Development of Dengue Vaccine Components'', Brazilian Patent Application TBA, filed August 15, 2007 to Fundacao Butantan, having a place of business in Sao Paulo, Brazil. The patent rights in this invention have been assigned to the United States of America.

This notice announces the establishment of the HIT Policy Committee. The American Recovery and Reinvestment Act of 2009 (Pub. L. 111-5), section 13101, directs the establishment of the HIT Policy Committee. The HIT Policy Committee (also referred to as the ``Committee'') is charged with recommending to the National Coordinator a policy framework for the development and adoption of a nationwide health information technology infrastructure that permits the electronic exchange and use of health information as is consistent with the Federal Health IT Strategic Plan and that includes recommendations on the areas in which standards, implementation specifications, and certification criteria are needed. The HIT Policy Committee is also charged with recommending to the National Coordinator an order of priority for the development, harmonization, and recognition of such standards, specifications, and certification criteria.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of the following draft document available for public comment entitled ``Updating the List of Hazardous Drugs for the NIOSH Alert: Additions and Deletions to the NIOSH Hazardous Drug List.'' The document and instructions for submitting comments can be found at https://www.cdc.gov/niosh/review/public/105a/.

The Food and Drug Administration (FDA) is issuing this final rule to require important new organ-specific warnings and related labeling for over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic (IAAA) drug products. The new labeling informs consumers about the risk of liver injury when using acetaminophen and the risk of stomach bleeding when using nonsteroidal anti-inflammatory drugs (NSAIDS). The new labeling is required for all OTC IAAA drug products whether marketed under an OTC drug monograph or an approved new drug application (NDA).

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Clinical Center, 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 January 2, 2009, page 112 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 currently valid OMB control number.

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 guidance for industry (185) entitled ``Target Animal Safety for Veterinary Pharmaceutical Products,'' VICH GL43. The purpose of this harmonized guidance is to provide recommendations regarding target animal safety (TAS) evaluation for regulatory submission of an Investigational Veterinary Pharmaceutical Product (IVPP), which is appropriate for determining the safety of an IVPP in the target animal. The guidance includes recommendations on including identification of target organs, where possible, and confirmation of margin of safety, using the minimum number of animals appropriate for the studies.

Following the Senate Appropriations Committee's recommendation, the Health Resources and Services Administration (HRSA) will give funding preference during the FY 2009 competition to current and former Healthy Start grantees with expiring or recently expired project periods.

This document is guidance and a request for comments under section 13402 of the Health Information Technology for Economic and Clinical Health (HITECH) Act, Title XIII of Division A and Title IV of Division B of the American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111-5). ARRA was enacted on February 17, 2009. The HITECH Act (the Act) at section 13402 requires the Department of Health and Human Services (HHS) to issue interim final regulations within 180 days of enactment to require covered entities under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and their business associates to provide for notification in the case of breaches of unsecured protected health information. For purposes of these requirements, section 13402(h) of the Act defines ``unsecured protected health information'' to mean protected health information that is not secured through the use of a technology or methodology specified by the Secretary in guidance, and requires the Secretary to issue such guidance no later than 60 days after enactment and to specify within the technologies and methodologies that render protected health information unusable, unreadable, or indecipherable to unauthorized individuals. Through this document, HHS is issuing the required guidance and seeking public comment both on the guidance as well as the breach notification provisions of the Act generally to inform the future rulemaking and updates to the guidance.

The Food and Drug Administration (FDA) is confirming the effective date of April 27, 2009, for the 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.'' The agency is also establishing a compliance date of October 26, 2009, for this rule in order to allow additional time for renderers to comply with the new requirements. This additional time will also give other affected persons, including cattle producers and packers, more time to identify appropriate methods for disposing of material prohibited from use in animal feed by this rule.

This proposed rule would set forth the hospice wage index for fiscal year 2010. The proposed rule would adopt a MedPAC recommendation regarding a process for certification and recertification of terminal illness. This proposed rule would also continue the phase-out of the wage index budget neutrality adjustment factor (BNAF), which will conclude in 2011. In addition, we are requesting comments on a suggestion to require recertification visits by physicians or advanced practice nurses, and on issues of payment reform for use in possible future policy development. Finally, the proposed rule would make several technical and clarifying changes to the regulatory text.

The Health Resources and Services Administration (HRSA) is issuing a non-competitive replacement award of Part C Early Intervention Services funds under Title XXVI of the Public Health Service Act, as amended by the Ryan White HIV/AIDS Treatment Modernization Act of 2006, to the Reading Hospital for services previously provided by the St. Joseph Medical Center in order to ensure continuity of critical HIV medical care and treatment services and to avoid a disruption of HIV clinical care to clients in the city of Reading, Pennsylvania, and all of Berks and Schuylkill Counties.

This notice announces changes made by the Genetic Information Nondiscrimination Act of 2008 (GINA) and the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) to section 1882 of the Social Security Act (the Act), which governs Medicare supplemental insurance. This notice also recognizes that the Model Regulation adopted by the National Association of Insurance Commissioners (NAIC) on September 24, 2008, is considered to be the applicable NAIC Model Regulation for purposes of section 1882 of the Act, subject to our clarifications that are set forth in this notice.

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: ``Building an Implementation Toolset for E-Prescribing.'' 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.

This correcting amendment corrects a technical error in the regulations text in the final rule published in the Federal Register on December 19, 2008 (73 FR 77904) entitled, ``Disproportionate Share Hospital Payments.'' In that final rule, we set forth data elements necessary to comply with the requirements of section 1923(j) of the Social Security Act (the Act) related to auditing and reporting of disproportionate share hospital payments under State Medicaid programs. The effective date was January 19, 2009.

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 requesting public comment on draft guidelines entitled ``National Institutes of Health Guidelines for Human Stem Cell Research'' (Guidelines).

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.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting is open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meeting and/or participate in the public comment session should e-mail acmh@osophs.dhhs.gov.

The Federal Medical Assistance Percentages (FMAPs) for the first two quarters of Fiscal Year 2009 have been recalculated pursuant to the American Recovery and Reinvestment Act (ARRA). These percentages will be effective from October 1, 2008 through March 31, 2009. This notice announces the calculated FMAPs that the U.S. Department of Health and Human Services (HHS) will use in determining the amount of Federal matching for State medical assistance under Title XIX and Title IV-E. The table gives figures for each of the 50 States and the District of Columbia. Adjusted figures are not shown for Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands since territories have a choice between two methodologies to determine their recalculated figures. Programs under title XIX of the Act exist in each jurisdiction. The percentages in this notice only apply to State expenditures for most medical services and medical insurance services. The statute provides separately for Federal matching of administrative costs.

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 proposed extension of the collection of information related to emergency use authorizations (EUAs) by the agency.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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, to be held by teleconference. This meeting will be equivalent to an in-person meeting and will be open to the public. Pre- registration is required for both public attendance by phone as well as public comment. Any individual who wishes to attend the meeting and/or participate in the public comment session should e-mail nvpo@hhs.gov.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and `Lookback''' 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 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 a public meeting entitled ``Preparation for ICH meetings in Yokohama, Japan'' to provide information and receive comments on the International Conference on Harmonisation (ICH) as well as the upcoming meetings in Yokohama, Japan. The topics to be discussed are the topics for discussion at the forthcoming ICH Steering Committee Meeting. The purpose of the meeting is to solicit public input prior to the next Steering Committee and Expert Working Groups meetings in Yokohama, Japan, scheduled for June 6 through 11, 2009, at which discussion of the topics underway and the future of ICH will continue, as well as provide comprehensive updates of the various ICH topics.

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 Office of the Director, 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 Department of Agriculture (USDA) and the Department of Health and Human Services (HHS) (a) provide notice of the third meeting of the Dietary Guidelines Advisory Committee, and (b) solicit written comments pertinent to a review of the Dietary Guidelines for Americans.

For many decades, the pediatric medical community, the public health community, and government agencies have recognized a range of questions regarding the use of therapeutics in children, including the shortage of clinical studies of drugs in children resulting in inadequate labeling for pediatric use. The lack of appropriate labeling results in off-label use of prescription drugs in many children and for many conditions. Contributing factors to this frequent off-label use of drugs in pediatrics include the rarity of some conditions in children with limited patient availability, the ethical concerns regarding the conduct of clinical trials in children, the lack of accurate information about which drugs are used by children, and the lack of long-term data on the medications that are frequently used.

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 Health Resources and Services Administration (HRSA) is issuing a temporary non-competitive replacement award to the National Jewish Hospital and Research Center to avoid disruption and continue outreach, medical screening and referral services to former uranium mine workers and individuals in the states of Colorado, Wyoming and portions of Southeastern Utah exposed to radioactive fallout during prior testing of nuclear weapons.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood Safety and Availability (ACBSA) will hold a meeting. The meeting will be open to the public.