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

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.