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

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the National Biodefense Science Board (NBSB) will be holding a public meeting. The meeting is open to the public.

The Food and Drug Administration (FDA) is announcing a public meeting entitled ``International Cooperation on Cosmetics Regulations (ICCR)Preparation for ICCR3 Meetings in Tokyo, Japan'' to provide information and receive comments on the International Cooperation on Cosmetics Regulations (ICCR) as well as the upcoming meetings in Tokyo, Japan. The topics to be discussed are the topics for discussion at the forthcoming ICCR steering committee meeting. The purpose of the meeting is to solicit public input prior to the next steering committee and expert working group meetings in Tokyo, Japan, scheduled for the week of September 7, 2009.

HHS gives notice concerning the final effect of the HHS decision to designate a class of employees at 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, 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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``E16 Genomic Biomarkers Related to Drug Response: Context, Structure, and Format of Qualification Submissions.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance describes recommendations regarding context, structure, and format of regulatory submissions for qualification of genomic biomarkers. The draft guidance is intended to foster consistency of applications across regions and facilitate joint discussions with and among regulatory authorities.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Drug-Induced Liver Injury: Premarketing Clinical Evaluation.'' This guidance is intended to assist the pharmaceutical industry and others engaged in new drug development in the assessment of the potential of a drug to cause severe drug-induced liver injury (DILI) during the conduct of premarketing trials. This guidance defines severe DILI as injury that is fatal or requires liver transplantation.

HRSA will be awarding noncompetitively Part C Ryan White HIV/ AIDS program funds to support comprehensive primary care services for persons living with HIV/AIDS including primary medical care, laboratory testing, oral health care, outpatient mental health and substance abuse treatment, specialty and subspecialty care, referrals for health and support services, and adherence monitoring/education services to the Wyoming Department of Health 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 State of Wyoming.

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 Heart, Lung, and Blood Institute (NHLBI), 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) has determined the regulatory review period for DUREZOL 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.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Nucleic Acid Testing (NAT) to Reduce the Possible Risk of Human Parvovirus B19 Transmission by Plasma-Derived Products,'' dated July 2009. The guidance document provides to manufacturers of plasma-derived products recommendations for performing parvovirus B19 NAT as an in-process test for Source Plasma and recovered plasma to identify and help to prevent the use of plasma units containing high levels of parvovirus B19. The guidance also recommends how to report to FDA implementation of parvovirus B19 NAT. The guidance announced in this notice finalizes the draft guidance of the same title, dated July 2008.

HHS gives notice concerning the final effect of the HHS decision to designate a class of employees at the Standard Oil Development Company in Linden, New Jersey, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On June 18, 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 Office of Community Services (OCS) announces the awarding of a $96,952 single source program expansion supplement to the Community Action Legal Services, Inc. (CAPLAW), located in Boston, MA, to support training and technical assistance on legal issues faced by Community Action Agencies (CAAs) related to the American Recovery and Reinvestment Act of 2009 (ARRA). The project activities are designed to support and strengthen the ability of the CAA network to comply with, and carry out, Community Services Block Grant (CSBG) activities funded by ARRA. The training projects and resources developed under the award will include analysis and explanation of the practical impact of ARRA for States and CSBG-eligible entities so that they can work more effectively to reach the ARRA goals and document how they have in fact reached those goals and used the ARRA funds. The project's overall approach is based on the following five key elements: (1) Technical assistance and issue-specific consultation; (2) Publications, including online postings on the CAPLAW Web site, e-Bulletins, and a print newsletter, which is also available on CAPLAW's Web site; (3) Online toolkit; (4) Presentations at CAA conferences, including CAPLAW's 2009 national training conference, and CAPLAW audio conferences.

This document withdraws the notice published on July 13, 2009 (74 FR 33449), which announced a hearing scheduled on August 4, 2009, to reconsider disapproval of Washington SPA 08-019. The July 13 notice is being withdrawn because it was an inadvertent republication of the same notice published on June 23, 2009 (74 FR 29703). This notice of withdrawal eliminates the duplication, by withdrawing the July 13 notice.

The Food and Drug Administration (FDA) is amending its new drug application (NDA) and abbreviated new drug application (ANDA)

This proposed notice acknowledges the receipt of a deeming application from the Accreditation Commission for Health Care (ACHC) for recognition as a national accrediting organization for hospices that wish to participate in the Medicare or Medicaid programs. Section 1865(a)(3)(A) of the Social Security Act requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.

This notice resolicits proposals for the private, for-profit demonstration project for the Program of All-Inclusive Care for the Elderly (PACE) and announces a closing date for the solicitation. We previously solicited proposals from private, for-profit organizations for a fully capitated joint Medicare and Medicaid demonstration.

The Department of Health and Human Services (HHS) is interested in encouraging HHS prime contractors to assist small businesses, small disadvantaged businesses, HUBZone businesses, veteran-owned businesses, service-disabled veteran-owned businesses, and woman-owned businesses, in enhancing their capabilities to perform contracts and subcontracts for HHS and other Federal agencies. The program seeks to provide a Mentor-Prot[eacute]g[eacute] Program that assists qualified small businesses to receive development assistance from HHS prime contractors in order to increase the base of small business eligible to perform HHS contracts and subcontracts.

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 Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of two new animal drug applications (NADAs) and an abbreviated new animal drug application (ANADA). In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of these NADAs and ANADA.

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 Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for three new animal drug applications (NADAs) and one abbreviated new animal drug application (ANADA) from Virbac AH, Inc., to Cross Vetpharm Group Ltd.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Export of Food and Drug Administration Regulated Products: Export Certificates'' 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 collection of information entitled ``Notice of Participation'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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: ``Study of Factors Influencing Consumer Choices Among Health Plans and Clinicians.'' 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 proposed information collection was previously published in the Federal Register on September 3rd, 2008 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. This notice differs from the 60 day notice in the following ways: (1) The number of responses has been decreased from 6,000 to 4,950, (2) the burden hours are decreased from 838 to 709, and (3) the descriptions of each experimental arm in the sections: Clinician Choice Experimental Design and Health Plan Choice Experimental Design were removed.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (198) entitled ``Draft Guidance for Industry on Bracketing and Matrixing Designs For Stability Testing of New Veterinary Drug Substances and Medicinal Products,'' VICH GL45. This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft guidance is an annex to a VICH guidance entitled ``Stability Testing of New Veterinary Drug Substances and Medicinal Products (Revision),'' VICH GL3(R), that published in the Federal Register of November 23, 2007 (72 FR 65751). This draft VICH guidance document is intended to provide guidance on the application of reduced designs (i.e., bracketing and matrixing) for stability studies conducted in accordance with the principles outlined in VICH GL3(R).

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.