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

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) permanently debarring Kim C. Hendrick, M.D., from providing services in any capacity to a person that has an approved or pending drug product application. We base this order on a finding that Dr. Hendrick was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product, and for conduct otherwise relating to the regulation of a drug product under the act. After being given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation, Dr. Hendrick failed to request a hearing. Dr. Hendrick's failure to request a hearing constitutes a waiver of his right to a hearing concerning this action.

The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization), as amended, for certain personal respiratory protection devices.\1\ FDA is issuing this Authorization under the Federal Food, Drug, and Cosmetic Act (the act), as requested by the Centers for Disease Control and Prevention (CDC). The Authorization contains, among other things, conditions on the emergency use of the authorized personal respiratory protection devices. The Authorization follows the determination by the Acting Secretary of the Department of Health and Human Services, Charles E. Johnson (the Acting Secretary), that a public health emergency exists involving Swine Influenza A (now known as 2009 H1N1 Influenza A or 2009 H1N1 flu) that affects, or has the significant potential to affect, national security. On the basis of such determination, the Acting Secretary declared an emergency justifying the authorization of the emergency use of certain disposable National Institute for Occupational Safety and Health (NIOSH) certified N95 respirators, accompanied by emergency use information subject to the terms of any authorization issued under the act. The Authorization, as amended, which includes an explanation of the reasons for its issuance, is reprinted in this document. Elsewhere in this issue of the Federal Register, FDA is announcing the issuance of EUAs for certain products from the neuraminidase class of antivirals, zanamivir and oseltamivir phosphate and the issuance of EUAs for certain in vitro diagnostic devices.

The Food and Drug Administration (FDA) is announcing the issuance of two Emergency Use Authorizations (EUAs) (the Authorizations) for certain products from the neuraminidase class of antiviralsZanamivir and oseltamivir phosphate. FDA is issuing the Authorizations under the Federal Food, Drug, and Cosmetic Act (the act), as requested by the Centers for Disease Control and Prevention (CDC). The Authorizations contain, among other things, conditions on the emergency use of the authorized zanamivir and oseltamivir phosphate products. The Authorizations follow the determination by the Acting Secretary of the Department of Health and Human Services, Charles E. Johnson (the Acting Secretary), that a public health emergency exists involving Swine Influenza A (now known as 2009 H1N1 Influenza A or 2009 H1N1 flu) that affects, or has the significant potential to affect, national security. On the basis of such determination, the Acting Secretary declared an emergency justifying the authorization of the emergency use of certain products from the neuraminidase class of antiviralsZanamivir and oseltamivir phosphate, accompanied by emergency use information subject to the terms of any authorization issued under the act. The Authorizations, which include an explanation of the reasons for issuance, are reprinted in this document. Elsewhere in this issue of the Federal Register, FDA is announcing the issuance of EUAs for certain in vitro diagnostic devices and the issuance of an EUA for certain personal respiratory protection devices.

The Food and Drug Administration (FDA) is announcing its intention to receive and consider a single source application for the award of a cooperative agreement in fiscal year 2009 (FY09) to the Dauphin Island Sea Lab (DISL). The goal of the DISL is marine science education, basic and applied marine science research, coastal zone management policy and educating the general public.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) has determined the regulatory review period for RECOTHROM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of three applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human biological product.

The Office of Refugee Resettlement (ORR) announces the award of program expansion supplements to five Wilson-Fish Program grantees. The Wilson-Fish Program is an alternative to traditional State- administered refugee assistance programs and provides integrated assistance and services to refugees, asylees, Amerasian Immigrants, Cuban and Haitian Entrants, Trafficking Victims and Iraqi/Afghani Special Immigrant Visas (SIVs). The five supplemental awards will allow the grantees to provide cash and medical assistance to arriving refugees and to others who are also eligible for refugee benefits through the remainder of Fiscal Year (FY) 2009. The expansion supplement awards will enable the grantees to provide services needed to a higher number of arrivals than originally planned. The Refugee Act of 1980 mandates that the ORR reimburse State agencies and Wilson-Fish projects for the costs of cash and medical assistance for newly arriving refugees. Since 1991, ORR has reimbursed State agencies and Wilson-Fish agencies for providing cash and medical assistance to eligible individuals during their first eight months in the United States. The following Wilson-Fish Program grantees are awarded program expansion supplemental funding:

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy.'' This guidance document describes a means by which manufacturers of dental amalgam, mercury, and amalgam alloy may comply with special controls that apply to these class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify dental amalgam into class II (special controls), reclassify dental mercury from class I (general controls) to class II (special controls), and designate a special controls guidance document to support the class II classification of these two devices, as well as the current class II classification of amalgam alloy.

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 Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2010 generic new animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Animal Generic Drug User Fee Act of 2008 (AGDUFA), authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, on certain generic new animal drug products, and on certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. This notice establishes the fee rates for FY 2010.

The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2010. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), the Medical Device User Fee Stabilization Act of 2005 (MDUFSA), and the Medical Device User Fee Amendments of 2007 (title II of the Food and Drug Administration Amendments Act of 2007 (FDAAA)), authorizes FDA to collect user fees for certain medical device submissions, and annual fees both for certain periodic reports and for certain establishments subject to registration. The FY 2010 fee rates are provided in this document. These fees apply from October 1, 2009, through September 30, 2010. To avoid delay in the review of your application, you should pay the fee before or at the time you submit your application to FDA. The fee you must pay is the fee that is in effect on the later of the date that your application is received by FDA or the date your fee payment is received. If you want to pay a reduced small business fee, you must qualify as a small business before you make your submission to FDA; if you do not qualify as a small business before you make your submission to FDA, you will have to pay the higher standard fee. This document provides information on how the fees for FY 2010 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Melons.'' This draft guidance is intended to cover the entire melon supply chain, both domestic firms and foreign firms exporting melons into the United States, to enhance the safety of melons by recommending practices to minimize microbial food safety hazards and to prevent microbial contamination. This draft guidance, when finalized, will supplement existing FDA guidances, including the 1998 ``Guidance to Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables,'' which applies to fresh produce commodities, and the 2008 ``Guidance to Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables,'' which applies to fresh-cut produce.

In accordance with the requirements of the Privacy Act of 1974, the Health Resources and Services Administration (HRSA) is proposing to alter four existing systems of records (SORs) for the reasons indicated below:

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 First Priority, Inc. The ANADA provides for use of nitrofurazone ointment on horses for prevention or treatment of superficial bacterial infections.

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).