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

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. Provisional Patent Application No. 60/850,132, filed October 6, 2006, now abandoned (HHS Ref. No. E-227-2006/0-US-01); U.S. Provisional Patent Application No. 60/864,153, filed November 02, 2006, now abandoned (HHS Ref. No. E-227-2006/1-US-01); U.S. Provisional Patent Application No. 60/888,754, filed February 07, 2007, now abandoned (HHS Ref. No. E-227-2006/2-US-01); U.S. Provisional Patent Application No. 60/910,549, filed April 06, 2007, now abandoned (HHS Ref. No. E-227- 2006/3-US-01); U.S. Provisional Patent Application No. 60/956,375, filed August 16, 2007, now abandoned (HHS Ref. No. E-227-2006/4-US-01); PCT Patent Application No. PCT/2007/080647, filed October 5, 2007, now abandoned (HHS Ref. No. E-227-2006/5-PCT-01); U.S. Patent Application No. 12/444,364, filed October 5, 2007 (HHS Ref. No. E-227-2006/5-US- 02); Canadian Patent Application (not yet determined) (HHS Ref. No. E- 227-2006/5-CA-03); Australian Patent Application No. 2007319576, filed October 5, 2007 (HHS Ref. No. E-227-2006/5-AU-04); and European Patent Application No. 07868382.8, filed October 5, 2007 (HHS Ref. No. E-227- 2006/5-EP-05), all of which are entitled ``Prevention of Tissue Ischemia, Related Methods and Compositions'', developed by Dr. David Roberts (NCI), Dr. Jeffrey Isenberg, and Dr. William Frazier. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be ``worldwide'', and the field of use may be limited to: (1) ``The use of antibodies including humanized antibodies reacting with CD47 or related antigens, precursors, or molecules, and isolated and/or recombinant fragments, and conjugates with an affinity for CD47 for the preservation or resuscitation of organs and tissues for transplantation''; (2) ``the use of antibodies including humanized antibodies reacting with CD47 or related antigens, precursors, or molecules, and isolated and/or recombinant fragments, and conjugates with an affinity for CD47 for treating or preventing vascular diseases, including but not limited to, pulmonary hypertension, sickle cell disease, myocardial infarction, stroke, and tissue ischemia resulting from trauma and surgical procedures''; (3) ``the use of antisense oligonucleotides or RNA formulations of stabilized composition to reduce expression of CD47 for treating wounds and/or burns and for use in reconstructive surgery''; and (4) ``use of small molecules antagonists of CD47 for treating or preventing vascular diseases including, but not limited to, thrombosis, hypertension, peripheral artery disease, renal artery disease, and ischemia resulting from atherosclerosis'' to Vasculox, Inc., having an office in at least St. Louis, Missouri, U.S.A. The patent rights in these inventions have been assigned to the United States of America.

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 Institute of Allergy and Infectious Diseases (NIAID), 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) 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 information collection provisions in FDA's food labeling regulations and on Form FDA 3570, ``Model Small Business Nutrition Labeling Exemption Notice,'' which small businesses may use to claim the small business exemption from nutrition labeling.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Postmarketing Studies and Clinical TrialsImplementation of Section 505(o) of the Federal Food, Drug, and Cosmetic Act.'' The Food and Drug Administration Amendments Act of 2007 (FDAAA) added new provisions to the Federal Food, Drug, and Cosmetic Act (the act) authorizing FDA to require certain postmarketing studies and clinical trials for prescription drugs and biological products approved under the act or the Public Health Service Act (the PHS Act). This draft guidance provides information on the implementation of the new provisions and a description of the types of postmarketing studies and clinical trials that will generally be required under the new legislation (postmarketing requirements (PMRs)) and the types that will generally be agreed-upon commitments (postmarketing commitments (PMCs)) because they do not meet the new statutory criteria for required postmarketing studies and clinical trials.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by Norbrook Laboratories, Ltd. The ANADA provides for the use of flunixin meglumine injectable solution in swine.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Alpharma Inc. The NADA provides for use of single-ingredient Type A medicated articles containing lasalocid and roxarsone to formulate two-way combination drug Type C medicated feeds for use in growing turkeys.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application.'' This document provides guidance to industry on postmarketing serious adverse event reporting for nonprescription (over-the-counter (OTC)) human drugs marketed without an approved application. It gives guidance on the minimum data elements that should be included in a serious adverse event report, the label that should be included with the report, reporting formats for paper and electronic submissions, and how and where to submit the reports. Separate guidance, issued by FDA's Center for Food Safety and Applied Nutrition on adverse event reporting for dietary supplements, is announced elsewhere in this issue of the Federal Register.

The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ``Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.'' The document provides guidance to the dietary supplement industry for complying with the serious adverse event reporting and recordkeeping requirements prescribed for dietary supplement manufacturers, packers, and distributors by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (the DSNDCPA). Separate guidance, issued by FDA's Center for Drug Evaluation and Research, on reporting for nonprescription (over-the-counter (OTC)) human drugs marketed without an approved application, is announced elsewhere in this issue of the Federal Register.

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 biological agents and toxins listed in Sec. 73.3 of Title 42 of the Code of Federal Regulations have been determined by the Secretary of the U.S. Department of Health and Human Services (HHS Secretary) to have the potential to pose a severe threat to public health and safety. We are now proposing to add SARS-associated coronavirus (SARS-CoV) to the list of HHS select agents and toxins. We are proposing this action because (1) SARS-CoV can cause significant mortality, especially in the elderly; (2) the virus has the capability of easily being transmitted from human to human; (3) there is currently no vaccine or antiviral approved for the prevention or treatment of infections caused by the SARS-CoV virus; and (4) it has been documented that the virus may persist in the environment.

This document corrects a technical error in the proposed rule entitled ``Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2010'' which appears elsewhere in this Federal Register.

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 this notice. This notice solicits comments on the collection of information contained in the Public Health Service (PHS) guideline entitled ``PHS Guideline on Infectious Disease Issues in Xenotransplantation'' dated January 19, 2001.

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 hereby publishing final ``National Institutes of Health Guidelines for Human Stem Cell Research'' (Guidelines).

Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case:

In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the establishment of a CMP that CMS plans to conduct with various Participating States. We have provided information about the matching program in the ``Supplementary Information'' section below. The Privacy Act provides an opportunity for interested persons to comment on the matching program. We may defer implementation of this matching program if we receive comments that persuade us to defer implementation. See ``Effective Dates'' section below for comment period.

Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold its twentieth meeting. The meeting will be open to the public.

The Centers for Disease Control and Prevention (CDC), within the U.S. Department of Health and Human Services (HHS), is proposing to revise the Part 34 regulation to remove ``Human Immunodeficiency Virus (HIV) infection'' from the definition of ``communicable disease of public health significance.'' HHS/CDC is also proposing to remove references to ``HIV'' from the scope of examinations in its regulations. Aliens infected with a ``communicable disease of public health significance'' are inadmissible into the United States under the Immigration and Nationality Act (INA).

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), 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 May 1, 2009, (Vol. 74, No. 83, p. 20320) and allowed 60 days for public comment. One public comment was received on May 1, 2009 requesting a copy of the data collection plans. An e-mail response was sent on May 5, 2009, which included the Supporting Statements and the screenshots of the surveys. 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.

This is notice, in accordance with 35 U.S.C. 209(c)(l) and 37 CFR Part 404.7(a)(l)(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 PCT/US2001/09425 [HHS Ref. E-109-2000/0-PCT-01], US Patent Application 10/472,874 [HHS Ref. E-109-2000/0-US-02], both entitled ``Molecular Neurochirurgerie for Pain Control Administering Locally Capsaicin or Resiniferatoxin'', and Canadian Patent Application 2442049 [HHS Ref. E-109-2000/0-CA-03] entitled ``Selective Ablation of Pain-Sensing Neurons by Administration of a Vanilloid Receptor Agonist'', and all continuing applications and foreign counterparts, to Sherrington Pharmaceuticals, which has offices in New York, N.Y. The patent rights in these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America.

The Food and Drug Administration (FDA) is establishing a public docket to obtain information on the implementation of the Family Smoking Prevention and Tobacco Control Act. FDA is establishing this docket in order to provide an opportunity for all interested parties to provide information and share views on the implementation of the new law.

HHS gives notice of a decision to designate a class of employees for Area IV of the Santa Susana Field Laboratory, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On June 18, 2009, the Secretary of HHS designated the following class of employees as an addition to the SEC:

This rule finalizes our proposal to rescind the December 28, 2007 final rule entitled, ``Elimination of Reimbursement under Medicaid for School Administration Expenditures and Costs Related to Transportation of School-Age Children Between Home and School;'' the November 7, 2008 final rule entitled, ``Clarification of Outpatient Hospital Facility (Including Outpatient Hospital Clinic) Services Definition;'' and certain provisions of the December 4, 2007 interim final rule entitled, ``Optional State Plan Case Management Services.'' These regulations have been the subject of Congressional moratoria and have not yet been implemented (or, with respect to the case management interim final rule, have only been partially implemented) by CMS. In light of concerns raised about the adverse effects that could result from these regulations, in particular, the potential restrictions on services available to beneficiaries and the lack of clear evidence demonstrating that the approaches taken in the regulations are warranted, CMS is rescinding the two final rules in full, and partially rescinding the interim final rule. Rescinding these provisions will permit further opportunity to determine the best approach to further the objectives of the Medicaid program in providing necessary health benefits coverage to needy individuals.

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 IT Community Tracking Study 2009.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection.

In accordance with the Privacy Act of 1974, as amended, OCSE is publishing notice of a new computer matching program between OCSE and State Agencies administering the Supplemental Nutrition Assistance Program (SNAP).

CMS proposes to add a new routine use to its inventory of SOR subject to the Privacy Act of 1974 (Title 5 United States Code (U.S.C.) 552a) authorizing disclosure of individually identifiable information to assist in efforts to respond to a suspected or confirmed breach of the security or confidentiality of information maintained in these systems of records. The new routine use will be prioritized in the next consecutive numbered order of routine uses in each system notice and will be included in the next published notice as part of our normal SOR review process. The new routine use will read as follows: