Department of Health and Human Services August 2011 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is requesting comments, including scientific and other information, concerning the harmful and potentially harmful constituents (HPHCs) in tobacco products and tobacco smoke. This information will assist the Agency in establishing a list of HPHCs in tobacco products and tobacco smoke (the HPHC list).

The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Children's Bureau (CB) announces the award of a single source program expansion supplement grant to the Tribal Law and Policy Institute, West Hollywood, CA, for the National Resource Center (NRC) for Tribes. The program expansion supplement funds will be used to provide technical assistance and support for the planning, development and implementation of the Tribal Maternal, Infant and Early Childhood Home Visiting program. The NRC for Tribes will provide technical assistance to ACF Tribal Home Visiting grantees to enhance their capacity to plan for and implement high-quality, evidence-based, and evidence-informed programs. Implementation of the NRC4Tribes work will include engaging, assessing, informing and supporting culturally-appropriate Tribal home visiting services that are part of coordinated early childhood systems in the American Indian and Alaska Natives (AIAN) communities and that support quality and effectiveness of services for AIAN children, youth, and families, which leads to increased safety, permanency, and well-being for children. The Tribal Law and Policy Institute NRC for Tribes and its partner agencies are uniquely qualified to provide training and technical assistance to Tribes based upon their experience, expertise, and commitment to increasing cultural competency and sensitivity to the Tribal point of view in training and technical assistance. The NRC for Tribes expertise in Tribal culture, child maltreatment prevention, collaboration, evaluation, and implementation of evidence-based programs and practices makes them an appropriate recipient of supplemental funds to carry out this project. Amount of Award: $150,000. Project Period: May 15, 2011 to September 30, 2011.

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 amending the animal drug regulations to reflect a change of sponsor for five new animal drug applications (NADAs) from Fort Dodge Animal Health, Division of Wyeth Holdings Corp., a wholly owned subsidiary of Pfizer, Inc., to Boehringer Ingelheim Vetmedica, Inc.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes recommendations regarding the context, structure, and format of qualification submissions for clinical and nonclinical genomic biomarkers related to development of drug or biotechnology products, including translational medicine approaches, pharmacokinetics, pharmacodynamics, and efficacy and safety aspects. The guidance is intended to create a harmonized recommended structure for biomarker qualification applications that will foster consistency of applications across regions and facilitate discussions with and among regulatory authorities.

This notice extends the deadline for submitting supporting information to request a temporary code under the Treatment of Certain Complex Diagnostic Laboratory Tests Demonstration. The deadline for submitting supporting information to request a temporary code under the Demonstration, which ended on August 1, 2011, has been extended to September 6, 2011.

Through this advance notice of proposed rulemaking (ANPRM), the Office of the National Coordination for Health Information Technology (ONC) is soliciting public comments on metadata standards to support nationwide electronic health information exchange. We are specifically interested in public comments on the following categories of metadata recommended by both the HIT Policy Committee and HIT Standards Committee: patient identity; provenance; and privacy. We also request public comments on any additional metadata categories, metadata elements, or metadata syntax that should be considered. The immediate scope of this ANPRM is the association of metadata with summary care records. More specifically, in the scenario where a patient obtains a summary care record from a health care provider's electronic health record technology or requests for it to be transmitted to their personal health record. Public comment, however, is also welcome on the use of metadata relative to other electronic health information contexts.

The Presidential Commission for the Study of Bioethical Issues will conduct its sixth meeting in August. At this meeting, the Commission will discuss research into the U.S. Public Health Service STD inoculation and serological studies in Guatemala from 1946-1948, and the current Federal standards regarding human subjects protection in scientific studies.

The Food and Drug Administration (FDA) is denying Ray Nathan's request for a hearing and is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Nathan from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Nathan was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product. Nathan has failed to file with the Agency information and analysis sufficient to create a basis for a hearing concerning this action.

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. Proposed Collection: Title: Hispanic Community Health Study (HCHS)/ Study of Latinos (SOL). Type of Information Collection Request: Revision of currently approved collection. (OMB 0925-0584). Need and Use of Information Collection: A baseline examination was conducted from March 3, 2008 to June 30, 2011. HCHS will follow-up new participants enrolled in the past year by telephone for dietary data, and continue to conduct annual follow-up of all participants by telephone to ascertain morbidity and mortality. Physicians/health care providers will be contacted to verify reported events for outcomes ascertainment. The Hispanic Community Health Study (HCHS)/Study of Latinos (SOL) will identify risk factors for cardiovascular and lung disease in Hispanic populations and determine the role of acculturation in the prevalence and development of these diseases. Frequency of Response: The participants will be contacted annually. Affected Public: Individuals or households; Businesses or other for profit; Small businesses or organizations. Type of Respondents: Individuals or households; physicians/health care providers. The annual reporting burden is as follows: Estimated Number of Respondents: 17,284; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: 0.3072; and Estimated Total Annual Burden Hours Requested: 5,309. The annualized cost to respondents is estimated at $104,718, assuming respondents time at the rate of $15 per hour and physician time at the rate of $55 per hour. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

The Food and Drug Administration (FDA) is amending the special controls for the herpes simplex virus (HSV) serological assay device type, which is classified as class II (special controls). These device types are devices that consist of antigens and antisera used in various serological tests to identify antibodies to herpes simplex virus in serum, and the devices that consist of herpes simplex virus antisera conjugated with a fluorescent dye (immunofluorescent assays) used to identify herpes simplex virus directly from clinical specimens or tissue culture isolates derived from clinical specimens.

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 issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Andrew K. Choi, M.D. for 4 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on findings that Dr. Choi was convicted of a misdemeanor under Federal law for conduct relating to the regulation of a drug product under the FD&C Act and that the type of conduct underlying the conviction undermines the process for the regulation of drugs. Dr. Choi was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Choi failed to respond. Dr. Choi's failure to respond constitutes a waiver of his right to a hearing concerning this action.

The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following class III preamendments device: Cardiovascular permanent pacemaker electrode. The Agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring this device to meet the statute's approval requirements and the benefits to the public from the use of the device. In addition, FDA is announcing the opportunity for interested persons to request that the Agency change the classification of the cardiovascular permanent pacemaker electrode based on new information. This action implements certain statutory requirements.

The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the Cranial Electrotherapy Stimulator. The Agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring this device to meet the statute's approval requirements and the benefits to the public from the use of the device. In addition, FDA is announcing the opportunity for interested persons to request that the Agency change the classification of the cranial electrotherapy stimulator based on new information. This action implements certain statutory requirements.

This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January through March 2011, relating to the Medicare and Medicaid programs and other programs administered by CMS. It also solicits comments on a process that CMS is considering to provide current up-to-date information in a Web friendly format. We are soliciting feedback on options that would improve accessibility and be less burdensome to beneficiaries, providers, and suppliers.

Notice is hereby given that the National Institute of Nursing Research (NINR), National Institutes of Health (NIH), Department of Health and Human Services, will convene a scientific summit titled ``The Science of CompassionFuture Directions in End-of-Life and Palliative Care.'' The summit is cosponsored by the NIH Office of Rare Diseases Research, the NIH Office of Research on Women's Health, the National Center for Complementary and Alternative Medicine, the National Institute on Aging, and the NIH Clinical Center Department of Bioethics. Portions of the event are supported by the Foundation for the National Institutes of Health and Pfizer.

In Fiscal Year 2006, in an effort to assist States and local health departments to ensure that newly arriving refugees have access to preventive health screenings, the Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR), Division of Refugee Assistance (DRA) awarded, through competition, a Refugee Preventive Health grant to the North Dakota Department of Human Services for a project period of July 1, 2006 to June 30, 2011. The North Dakota Department of Human Services has relinquished the grant. ORR announces the award of a single-source replacement grant to Lutheran Social Services of North Dakota of Fargo, ND, a non-profit organization engaged in the resettlement of refugees, to continue services under the Refugee Preventive Health grant. Services provided under the grant to Lutheran Social Services of North Dakota are within the scope and operation of the original award, and address the preventive health needs of refugees in their first year in the United States. The program includes initial health screening, treatment of immediate health needs, follow up on chronic illnesses, nursing case management, interpretation services and preventive health education. The project period for the award is July 1, 2010 to June 30, 2011.

This final rule will implement section 3004 of the Affordable Care Act, which establishes a new quality reporting program that provides for a 2 percent reduction in the annual increase factor beginning in 2014 for failure to report quality data to the Secretary of Health and Human Services. This final rule will also update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2012 (for discharges occurring on or after October 1, 2011 and on or before September 30, 2012) as required under section 1886(j)(3)(C) of the Social Security Act (the Act). Section 1886(j)(5) of the Act requires the Secretary to publish in the Federal Register on or before the August 1 that precedes the start of each FY the classification and weighting factors for the IRF prospective payment system (PPS) case-mix groups and a description of the methodology and data used in computing the prospective payment rates for that fiscal year. We are also consolidating, clarifying, and revising existing policies regarding IRF hospitals and IRF units of hospitals to eliminate unnecessary confusion and enhance consistency. Furthermore, in accordance with the general principles of the President's January 18, 2011 Executive Order entitled ``Improving Regulation and Regulatory Review,'' we are amending existing regulatory provisions regarding ''new'' facilities and changes in the bed size and square footage of IRFs and inpatient psychiatric facilities (IPFs) to improve clarity and remove obsolete material.

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.

Under the Food and Drug Administration Modernization Act of 1997 (Modernization Act), the Food and Drug Administration (FDA) is required to report annually in the Federal Register on the status of postmarketing requirements and commitments required of, or agreed upon by, holders of approved drug and biological products. This notice is the Agency's report on the status of the studies and clinical trials that applicants have agreed to, or are required to, conduct.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to modify or alter a SOR titled, ``Medicare Advantage Prescription Drug (MARx) System, No. 09-70-4001,'' last modified at 70 FR 60530 (October 18, 2005). CMS proposes to broaden the data collected and stored by this system as part of a redesign and modernization of the MARx System. On December 8, 2003, Congress passed the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173). MMA amended the Social Security Act (the Act) by adding the Medicare Part D Program under Title XVIII and mandated that CMS establish a voluntary Medicare prescription drug benefit program effective January 1, 2006. Under the Medicare Part D benefit, the Act allows Medicare payment to plans that contract with CMS to provide qualified Part D prescription drug coverage as described in 42 Code of Federal Regulations (CFR) 423.401. The MARx System processes all enrollment/disenrollment transactions associated with the Part D program. The modified MARx System will accept and store Health Plan-supplied beneficiary residence addresses on an initial Part C and/or Part D enrollment or a subsequent record update transaction from the Plan. The main source of beneficiary residence address is the Social Security Administration (SSA). The address SSA provides, however, may not be the beneficiary's residence address. Beneficiary addresses are initially provided by SSA from the beneficiary's enrollment in Part A and/or Part B, and frequently reflect an address of a representative payee or a Post Office (P.O.) Box, not the residence of the beneficiary. This limits the effectiveness of geographically-sensitive Plan payment decisions. Plans have more accurate beneficiary address information, which is updated on a case-by-case basis. CMS wishes to allow this data to be transmitted in initial enrollment and subsequent record update transactions from the Plans, and additionally translated into valid residence address State and County Codes for subsequent use in service area determination. Support for Plan-supplied residence address will improve the accurate application of geographically sensitive rates in Plan payment calculation. The Plan-supplied beneficiary residence address will be updated and saved with the beneficiary's enrollment data in the MARx System. The residence address provided by the Plan will only apply to periods when the beneficiary is enrolled in that Plan. We propose to modify existing routine use number 1 that permits disclosure to agency contractors and consultants to include disclosure to CMS grantees who perform a task for the agency. CMS grantees, charges with completing projects or activities that require CMS data to carry out that activity, are classified separate from CMS contractors and/or consultants. The modified routine use will remain as routine use number 1. We will delete routine use number 7 authorizing disclosure to support constituent requests made to a congressional representative. If an authorization for the disclosure has been obtained from the data subject, then no routine use is needed. We will broaden the scope of published routine uses number 8 and 9, authorizing disclosures to combat fraud and abuse in the Medicare and Medicaid programs to include combating ``waste'' which refers to specific beneficiary/recipient practices that result in unnecessary cost to all Federally-funded health benefit programs. We will add a new routine use 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. We are modifying the language in the remaining routine uses to provide a proper explanation as to the need for the routine use and to provide clarity to CMS's intention to disclose individual-specific information contained in this system. The routine uses will then be prioritized and reordered according to their usage. We will also take the opportunity to update language in the administrative sections to correspond with language used in other CMS SORs. We propose to assign a new CMS identification number to this system to simplify the obsolete and confusing numbering system originally designed to identify the Bureau, Office, or Center that maintained information in the Health Care Financing Administration systems of records. The new assigned identifying number for this system should read: System No. 09-70-0588. The primary purpose of the SOR is to maintain a master file of Medicare Advantage (MA) and Medicare Advantage Prescription Drug (MA- PD) plan members for accounting and payment control; expedite the exchange of data with MA and MA-PD; control the posting of pro-rata amounts to the Part B deductible of currently enrolled MA members; and track participation of the prescription drug benefits provided under prescription drug plans (PDPs) and Medicare employer plans. Information in this system is disclosed to: (1) Support regulatory, reimbursement, and policy functions performed by a contractor, consultant, or CMS grantee contracted by the Agency; (2) support another Federal or State agency, agency of a state government, an agency established by state law, or its fiscal agent; (3) assist providers and suppliers of service directly or dealing through contractors, fiscal intermediaries (FI) or carriers for the administration of Title XVIII Medicaid state agency; (4) assist third party contacts in situations where the party to be contacted has, or is expected to have information relating to the individual's capacity to manage his or her affairs; (5) assist insurance companies, third party administrators, employers, self-insurers, managed care organizations, and other supplemental insurers; (6) facilitate research on the quality and effectiveness of care provided, as well as payment-related projects; (7) support litigation involving the Agency; (8) combat fraud and abuse in certain health benefits programs, and (9) assist in a response to a suspected or confirmed breach of the security or confidentiality of information. CMS has provided background information about the modified system in the Supplementary Information section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See ``Effective Dates'' section for comment period.

The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the class III preamendments device pacemaker programmers. The agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring this device to meet the statute's approval requirements and the benefits to the public from the use of the devices. In addition, FDA is announcing the opportunity for interested persons to request that the agency change the classification of the aforementioned device based on new information. This action implements certain statutory requirements.

The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for oral formulations of doxycycline for the post-exposure prophylaxis of inhalational anthrax during a public health emergency involving aerosolized Bacillus anthracis (B. anthracis). FDA is issuing this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C 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 doxycycline products. The Authorization follows the determination by the Secretary of the Department of Homeland Security (DHS) that there is a significant potential for a domestic emergency involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent or agentsin this case, B. anthracis. On the basis of such determination, the Secretary of the Department of Health and Human Services (HHS) declared an emergency justifying the authorization of the emergency use of doxycycline hyclate tablets, accompanied by emergency use information, and later renewed that declaration. The Secretary of HHS then renewed and amended that declaration so that it applies to all doxycycline products covered by this authorization. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.

This notice with comment period describes the general criteria we intend to use to evaluate the effectiveness and efficiency of Quality Improvement Organizations (QIOs) that will enter into contracts with CMS under the 10th Statement of Work (SOW) on August 1, 2011. The evaluation of a QIOs' performance related to their SOW will be based on evaluation criteria specified for the aims, drivers, tasks, and subtasks set forth in section J-10 of the QIOs' 10th SOW.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Submission of Petitions: Food Additive, Color Additive (Including Labeling), and Generally Recognized as Safe Affirmation; Electronic Submission Using Food and Drug Administration Form 3503'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA), the Director of the Center for Drug Evaluation and Research (the Center Director), is proposing to refuse to approve a supplemental new drug application submitted by ISTA Pharmaceuticals, Inc. (ISTA), for a new 2.4 milliliter (mL) fill size for Bromday (bromfenac ophthalmic solution), 0.09%. This notice summarizes the grounds for the proposal of the Center for Drug Evaluation and Research (CDER) and offers ISTA an opportunity to request a hearing on the matter.

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: ``Evaluation of the Technical Assistance to ARRA Complex Patient Grantees Project'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.

Under the provisions 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 Cancer Institute (NCI), 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. Proposed Collection: Title: A Generic Submission for Theory Development and Validation (NCI). Type of Information Collection Request: NEW. Need and Use of Information Collection: In order to carry out NCI's legislative mandate to conduct and support research with respect to the causes and prevention of cancer, it is beneficial for NCI, through initiatives in the Behavioral Research Program (BRP), to conduct and support behavioral research informed by and informing theory. Formative research in the area of theory development and validation would provide the basis for developing effective cancer prevention and control strategies, allow for a better understanding of theoretical constructs that influence decisions and actions related to cancer, and ultimately contribute to reducing the U.S. cancer burden. Data collections that result from this generic clearance would inform and clarify the use of theory in BRP-supported initiatives and funding announcements. Specifically, this research would allow NCI to conduct research to: (1) Identify psychological, biobehavioral, demographic, and individual difference predictors of cancer prevention and control behaviors and outcomes; (2) Develop and refine integrative theories; (3) Identify and observe theoretical and innovative trends in cancer prevention and control research; and (4) Determine feasibility and usefulness of collaborative and multidisciplinary approaches to cancer prevention and control. Frequency of Response: Will be determined by each project. Affected Public: Individuals or households; Businesses or other for profit; Not-for-profit institutions; Federal Government; State, Local, or Tribal Government. Type of Respondents: Members of the public including, but not limited to, health professionals, physicians, and researchers. Table 1 outlines the estimated burden hours and cost required for a three-year approval of this generic submission.

This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award approximately $1.102 million (total costs) per year for up to three years to the National Association of State Alcohol and Drug Abuse Directors (NASADAD). This is not a formal request for applications. Assistance will be provided only to the National Association of State Alcohol and Drug Abuse Directors (NASADAD) based on the receipt of a satisfactory application that is approved by an independent review group. Funding Opportunity Title: TI-11-006.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry and FDA Staff: Investigational New Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications,'' dated June 2011. The guidance document provides advice to potential sponsors to assist in the submission of an IND for certain minimally manipulated hematopoietic stem/progenitor cells from placental/ umbilical cord blood, from an unrelated allogeneic cord blood donor and intended for hematopoietic reconstitution in patients with specified indications (HPC-Cs), when such HPC-Cs are not licensed and when a suitable human leukocyte antigen (HLA) matched cord blood transplant is needed for treatment of a patient with a serious or life-threatening disease or condition, and there is no satisfactory alternative treatment. If such HPC-Cs are made available for clinical use, they must be distributed under an IND. The guidance announced in this notice finalizes the draft guidance of the same title dated October 2009.

The Food and Drug Administration (FDA) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 027'' (Recognition List Number: 027), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

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 for public comment entitled ``NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2012: Proposed 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/docket/ review/docket190/default.html. This guidance document does not have the force and effect of law. Public Comment Period: Comments must be received by October 3, 2011.

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.

This notice finalizes the methodology that will be used to calculate reimbursement rates applicable to fiscal years 2010 and beyond for assistance payments under the tribal Foster Care, Adoption Assistance and Guardianship Assistance Programs authorized by title IV- E of the Social Security Act. A Notice with Comment Period on this topic was previously published on October 8, 2010.

The Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2012 animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Animal Drug User Fee Act of 2003 (ADUFA) and the Animal Drug User Fee Amendments of 2008 (ADUFA II), authorizes FDA to collect user fees for certain animal drug applications and supplements, on certain animal drug products, on certain establishments where such products are made, and on certain sponsors of such animal drug applications and/or investigational animal drug submissions. This notice establishes the fee rates for FY 2012.

The Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2012 generic new animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the FD&C 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 2012.

The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees for fiscal year (FY) 2012. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Prescription Drug User Fee Amendments of 2007 (Title 1 of the Food and Drug Administration Amendments Act of 2007 (FDAAA)) (PDUFA IV), authorizes FDA to collect user fees for certain applications for approval of drug and biological products, on establishments where the products are made, and on such products. Base revenue amounts to be generated from PDUFA fees were established by PDUFA IV, with provisions for certain adjustments. Fee revenue amounts for applications, establishments, and products are to be established each year by FDA so that one-third of the PDUFA fee revenues FDA collects each year will be generated from each of these categories. This document establishes fee rates for FY 2012 for application fees for an application requiring clinical data ($1,841,500), for an application not requiring clinical data or a supplement requiring clinical data ($920,750), for establishment fees ($520,100), and for product fees ($98,970). These fees are effective on October 1, 2011, and will remain in effect through September 30, 2012. For applications and supplements that are submitted on or after October 1, 2011, the new fee schedule must be used. Invoices for establishment and product fees for FY 2012 will be issued in August 2011, using the new fee schedule.