Department of Health and Human Services April 2011 – Federal Register Recent Federal Regulation Documents
Results 201 - 323 of 323
Disqualification of a Clinical Investigator
The Food and Drug Administration (FDA) is proposing to amend the regulations to expand the scope of clinical investigator disqualification. Under this proposal, when the Commissioner of Food and Drugs determines that an investigator is ineligible to receive certain test articles (drugs, devices, or new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA. This proposal is based in part upon recommendations from the Government Accountability Office, and is intended to help ensure adequate protection of research subjects and the quality and integrity of data submitted to FDA. FDA also is amending the list of regulatory provisions under which an informal regulatory hearing is available by changing the scope of certain provisions and adding regulatory provisions that were inadvertently omitted.
FDA Food Safety Modernization Act: Focus on Preventive Controls for Facilities; Public Meeting
The Food and Drug Administration (FDA) is announcing a public meeting entitled ``FDA Food Safety Modernization Act: Focus on Preventive Controls for Facilities.'' The purpose of the public meeting is to provide interested persons an opportunity to discuss implementation of the preventive controls for facilities provisions of the recently enacted FDA Food Safety Modernization Act (FSMA). FDA is seeking information on preventive controls used by facilities to identify and address hazards associated with specific types of food and specific processes. The public will have an opportunity to provide information and share views that will inform the development of guidance and regulations on preventive controls for food facilities that manufacture, process, pack or hold human food or animal food and feed (including pet food).
HHS Plan for Retrospective Review Under Executive Order 13563
In accordance with Executive Order 13563, ``Improving Regulation and Regulatory Review,'' the Department of Health and Human Services (HHS) seeks comment from interested parties to assist in the development of its preliminary plan to review existing regulations. The purpose of the plan is to establish a process by which HHS can determine whether any such regulations should be modified, streamlined, expanded, or repealed so as to make HHS's regulatory program more effective or less burdensome in achieving its regulatory objectives.
Notice of Intent To Award Affordable Care Act (ACA) Funding
This notice provides public announcement of CDC's intent to award Affordable Care Act (ACA) appropriations to the Connecticut Department of Public Health and the Georgia Department of Community Health to conduct vaccine effectiveness activities for rotavirus vaccine and 13-valent pneumococcal conjugate vaccine (PCV). These activities were requested by the two grantees in their FY 2011 non- competitive continuation applications submitted under funding opportunity CI05-026, ``Emerging Infections Program (EIP),'' Catalogue of Federal Domestic Assistance Number (CFDA): 93.283. Due to a lack of funding availability, these activities were either approved but unfunded or only partially funded in the grantee's FY 2011 continuation award. Only these two EIP sites requested funding for the rotavirus activities and only one site (Georgia) requested funding for the PCV activities. Since no other EIP sites requested funding for these specific activities, Connecticut and Georgia will be the only sites receiving funding for these activities. Approximately $433,500 in ACA funding will be awarded, which includes $333,500 for Rotavirus and $100,000 for PCV, to increase the amount of funding available to evaluate the effectiveness of new rotavirus and PCV vaccines currently being monitored through the aforementioned participating EIP sites. Funding is appropriated under the Affordable Care Act (PL 111-148), Title IV, Section 4002 (Prevention and Public Health Fund). Accordingly, CDC adds the following information to the previously published funding opportunity announcement:
Notice of Intent To Award Supplemental Affordable Care Act Funding
This notice provides public announcement of CDC's intent to use Affordable Care Act (ACA) appropriations to expand the Emerging Infectious Diseases (EID) Laboratory Fellowship Program currently supported through Funding Opportunity CDC-RFA-HM10-1001, ``APHL-CDC Partnership for Quality Laboratory Practice.'' Funding is appropriated under the Affordable Care Act (Pub. L. 111-148), Title IV, Section 4002 (Prevention and Public Health Fund). In addition, Under Section 5314, Fellowship Training in Public Health (Part E of title VII of the Public Health Service Act (42 U.S.C. 294n et seq., as amended by section 5206, is further amended by Sec. 778), CDC is authorized to expand existing fellowship training programs in the critical areas of applied public health epidemiology, public health laboratory science and public health informatics. The CFDA Number for this funding opportunity is 93.065. CDC will add the following ACA Authority to that which is reflected in the published Funding Opportunity CDC-RFA-HM10-1001:
Determination That KEFLEX (Cephalexin) Capsule, Equivalent to 333 Milligrams Base, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that KEFLEX (cephalexin) capsule, equivalent to (EQ) 333 milligrams (mg) base, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for cephalexin capsule, EQ 333 mg base, if all other legal and regulatory requirements are met.
Determination That FENTORA (Fentanyl Citrate) Buccal Tablet, 300 Micrograms, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that FENTORA (fentanyl citrate) buccal tablet, 300 micrograms (mcg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for fentanyl citrate buccal tablet, 300 mcg, if all other legal and regulatory requirements are met.
Cooperative Agreement With the University of Mississippi's National Center for Natural Products Research (U01) To Develop and Disseminate Botanical Natural Product Research With an Emphasis on Public Safety
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of a cooperative agreement with the University of Mississippi's National Center for Natural Products Research (UM-NCNPR). The goal of the cooperative agreement is to promote the efficient development and dissemination of natural products research and science and the programs developed under the agreement will complement the diverse activities of both the public and private sectors.
Supplemental Funding Under the Food and Drug Administration Pediatric Device Consortia Grant Program
The Food and Drug Administration (FDA) is announcing the availability of supplemental grant funds for the Pediatric Device Consortia Grant Program. The goal of this announcement is to allow an existing active grantee to compete for further funds listed under RFA- FD-11-002.
National Vaccine Injury Compensation Program: Statement of Reasons for Not Conducting Rule-Making Proceedings
In accordance with section 2114(c)(2)(B) of the Public Health Service Act, notice is hereby given of the reasons for not conducting a rule-making proceeding for adding Guillain-Barr[eacute] Syndrome (GBS) to the Vaccine Injury Table at this time.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Application for Participation in the Medical Device Fellowship Program
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Application for Participation in the Medical Device Fellowship Program'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Update of the 2003 Interagency Quantitative Assessment of the Relative Risk to Public Health From Foodborne Listeria Monocytogenes Among Selected Categories of Ready-to-Eat Foods; Request for Comments, Scientific Data and Information
The Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) are requesting comments and scientific data and information that would assist the agencies in their plan to update a risk assessment on the relationship between foodborne Listeria monocytogenes in selected categories of ready-to-eat (RTE) foods and human health. The purpose of the risk assessment is to incorporate newly available scientific data and information into the risk assessment in order to update estimates of the relative risk of illness and death associated with the consumption of different types of RTE foods that may be contaminated with L. monocytogenes and to evaluate the relative effectiveness of strategies to reduce or prevent exposure to L. monocytogenes from the consumption of RTE foods, including, for example, the impact of changing refrigerated time and temperature storage prior to consumption.
Office of the Assistant Secretary for Planning and Evaluation; Medicare Program; Meeting of the Technical Advisory Panel on Medicare Trustee Reports
This notice announces public meetings of the Technical Advisory Panel on Medicare Trustee Reports (Panel). Notice of these meetings is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)). The Panel will discuss the short- term (10 year) projection methods and assumptions in projecting Medicare health spending and may make recommendations to the Medicare Trustees on how the Trustees might more accurately estimate health spending in the short run. The Panel's discussion is expected to be very technical in nature and will focus on the actuarial and economic assumptions and methods by which Trustees might more accurately measure health spending. Although panelists are not limited in the topics they may discuss, the Panel is not expected to discuss or recommend changes in current or future Medicare provider payment rates or coverage policy. Meeting Date: April 12, 2011, 9 a.m. to 5 p.m. e.t.
Statement of Organizations, Functions, and Delegations of Authority
The Food and Drug Administration (FDA) has reorganized the Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE). This reorganization includes the organizations and their substructure components as listed in this document. This reorganization includes the establishment of six Staffs: Executive Operations and Strategic Planning Staff, Regulatory Science Staff, Regulatory Affairs Staff, Program Management and Analysis Staff, Project Management Staff, and Technical Information Staff. It will also include Office of Medication Error Prevention and Risk Management (OMEPRM) and Office of Pharmacovigilance and Epidemiology (OPE) under OSE. OMEPRM will consist of the Division of Risk Management and the Division of Medication Error Prevention and Analysis. OPE will consist of the Division of Epidemiology I and Division of Epidemiology II and the Division of Pharmacovigilance I and Division of Pharmacovigilance II. Also included are the abolishment of Business Process Improvement Staff, Regulatory Policy Staff, and Review Management Staff within OSE Immediate Office.
Cathryn Lyn Chatman (also known as Cathryn Lyn Garcia): Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Cathryn Lyn Chatman (also known as Cathryn Lyn Garcia) for 5 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 Ms. Chatman 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. Ms. Chatman was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Ms. Chatman failed to respond. Ms. Chatman's failure to respond constitutes a waiver of her right to a hearing concerning this action.
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and Fiscal Year 2011 Final Wage Indices Implementing the Medicare and Medicaid Extenders Act
This notice contains the final fiscal year (FY) 2011 wage indices and hospital reclassifications and other related tables which reflect changes required by or resulting from the implementation of section 102 of the Medicare and Medicaid Extenders Act of 2010. MMEA requires the extension of the expiration date for certain geographic reclassifications and special exception wage indices through September 30, 2011.
Medicare Program; Waiver Designs in Connection With the Medicare Shared Savings Program and the Innovation Center
Section 1899(f) of the Social Security Act (of the Act), as added by the Affordable Care Act (ACA) authorizes the Secretary to waive certain fraud and abuse laws as necessary to carry out the provisions of section 1899 of the Act (the Medicare Shared Savings Program). This notice with comment period describes and solicits public input regarding possible waivers of the application of the Physician Self-Referral Law, the Federal anti-kickback statute, and certain civil monetary penalties (CMP) law provisions to specified financial arrangements involving accountable care organizations (ACOs) under the Medicare Shared Savings Program. In addition, section 1115A(d)(1) of the Act, as added by section 3021 of the ACA, authorizes the Secretary to waive the same fraud and abuse laws, among others, as necessary solely for the purposes of carrying out the provisions of section 1115A of the Act with respect to the testing of certain innovative payment and service delivery models by the Center for Medicare and Medicaid Innovation. This notice with comment period also solicits public input regarding that separate waiver authority.
Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations
This proposed rule would implement section 3022 of the Affordable Care Act which contains provisions relating to Medicare payments to providers of services and suppliers participating in Accountable Care Organizations (ACOs). Under these provisions, providers of services and suppliers can continue to receive traditional Medicare fee-for-service payments under Parts A and B, and be eligible for additional payments based on meeting specified quality and savings requirements.
Submission for OMB Review; Comment Request; Short Follow-Up Questionnaire for the National Institutes of Health (NIH)-AARP Diet and Health Study (NCI)
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 February 4, 2011 (76 FR 6485) and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Short Follow-Up Questionnaire for the National Institutes of Health (NIH)-AARP Diet and Health Study (NCI). Type of Information Collection Request: Extension. Need and Use of Information Collection: The purpose of this short 2-page questionnaire is to obtain information on 18 different medical conditions, several medical procedures, and lifestyle characteristics from 485,909 participants of the NIH-AARP Diet and Health Study. The questionnaire will support the ongoing examination between cancer and nutritional exposures. A pilot mailing to 1,600 randomly selected NIH-AARP Diet and Health study participants confirmed the feasibility of the methodology and willingness of respondents to participate in this data collection effort. This questionnaire adheres to The Public Health Service Act, Section 412 (42 U.S.C. 285a-1) and Section 413 (42 U.S.C. 285a-2), which authorizes the Division of Cancer Epidemiology and Genetics of the National Cancer Institute (NCI) to establish and support programs for the detection, diagnosis, prevention and treatment of cancer; and to collect, identify, analyze and disseminate information on cancer research, diagnosis, prevention and treatment. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: U.S. adults (persons aged 50-85). The annual reporting burden is displayed in the table below. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.
Medicare Programs: Changes to the End-Stage Renal Disease Prospective Payment System Transition Budget-Neutrality Adjustment
This interim final rule with comment will revise the end-stage renal disease (ESRD) transition budget-neutrality adjustment finalized in the CY 2011 ESRD Prospective Payment System (PPS) final rule for renal dialysis services provided on April 1, 2011 through December 31, 2011. We are revising the transition budget-neutrality adjustment to reflect the actual election decision to receive payment under the ESRD PPS for renal dialysis services furnished on or after January 1, 2011 made by ESRD facilities, rather than projected elections using the same methodology as described in the ESRD PPS proposed and final rules. This results in a zero percent adjustment for renal dialysis services furnished April 1, 2011 through December 31, 2011.
Maria Carmen Palazzo: Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Maria Carmen Palazzo, 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. Palazzo was convicted of felonies under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product or otherwise relating to the regulation of any drug product under the FD&C Act. Dr. Palazzo was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Palazzo failed to respond. Dr. Palazzo's failure to respond constitutes a waiver of her right to a hearing concerning this action.
Request for Notification From Industry Organizations Interested in Participating in the Selection Process for a Nonvoting Industry Representative and Request for Nominations for a Nonvoting Industry Representative on an FDA Advisory Committee
The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on its Allergenic Products Advisory Committee notify FDA in writing. A nominee may either be self- nominated or nominated by an organization to serve as a nonvoting industry representative. Nomination will be accepted for current vacancies effective with this notice.
Food Labeling; Calorie Labeling of Articles of Food in Vending Machines
To implement the vending machine labeling provisions of the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act), the Food and Drug Administration (FDA) is proposing requirements for providing calorie information for certain articles of food sold from vending machines. The Affordable Care Act, in part, amended the Federal Food, Drug and Cosmetic Act (FD&C Act) to, among other things, require that for an article of food sold from a vending machine that does not permit a prospective purchaser to examine the Nutrition Facts Panel before purchasing the article, or does not otherwise provide visible nutrition information at the point of purchase, and is operated by a person engaged in the business of owning or operating 20 or more vending machines, the vending machine operator must disclose the number of calories for the article of food. Vending machine operators not subject to the requirements of the Affordable Care Act may elect to be subject to the Federal requirements by registering with FDA. Providing calorie disclosures for food sold from vending machines would assist consumers in making healthier dietary choices.
Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments
To implement the menu labeling provisions of the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act), the Food and Drug Administration (FDA) is proposing requirements for providing certain nutrition information for standard menu items in certain chain restaurants and similar retail food establishments. The Affordable Care Act, in part, amended the Federal Food, Drug, and Cosmetic Act (FD&C Act), among other things, to require restaurants and similar retail food establishments that are part of a chain with 20 or more locations doing business under the same name and offering for sale substantially the same menu items to provide calorie and other nutrition information for standard menu items, including food on display and self-service food. Under provisions of the Affordable Care Act, restaurants and similar retail food establishments not otherwise covered by the law may elect to become subject to the Federal requirements by registering every other year with the FDA. Providing calorie and other nutrition information in restaurants and similar retail food establishments would assist consumers in making healthier dietary choices.
Prospective Grant of Exclusive License: Device and System for Two Dimensional Analysis of Biomolecules From Tissue and Other Samples
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in PCT Patent Application No. PCT/US03/37208 [HHS Ref. No. E-339-2002/0-PCT- 02], filed November 20, 2003, which published as WO 2004/048928 on June 10, 2004, now expired, entitled ``Method And Apparatus for Performing Multiple Simultaneous Manipulations of Biomolecules In a Two- Dimensional Array;'' U.S. Patent Application No. 10/535,521 [HHS Ref. No. E-339-2002/0-US-03], filed May 18, 2005, now abandoned, which published as US-2006-0147926 A1 on July 6, 2006 entitled ``Method And Apparatus for Performing Multiple Simultaneous Manipulations of Biomolecules In a Two-Dimensional Array;'' U.S. Patent Application No. 12/587,976 [HHS Ref. No. E-339-2002/0-US-04], filed October 14, 2009, which published as US-2010-010506 on April 29, 2010 entitled ``Device for External Movement Manipulation of Nucleic Acids and/or Proteins;'' U.S. Provisional Patent Application No. 61/206,458 [HHS Ref. No. E-130- 2006/0-US-01] filed January 30, 2009, entitled, ``Amplification Platform and Methods of Use Thereof, now expired, and PCT Patent Application No. PCT/US10/022586 [HHS Ref. No. E-130-2006/0-PCT-02] filed January 29, 2010 and which published as WO 2010/088517 on August 5, 2010, entitled, ``Methods and Systems for Purifying, Transferring and/or Manipulating Nucleic Acids;'' and all continuing applications and foreign counterparts to 2-D Bio, LLC, having a place of business in Gaithersburg, Maryland. The patent rights in these inventions have been assigned to the United States of America. However, the patent rights for HHS Ref. No. E-130-2006/0-US-01 and HHS Ref. No. E-130-2006/0-PCT- 02 are co-owned and co-assigned to the University of Maryland. The United States of America has obtained an exclusive license to the University of Maryland's rights in the invention. The prospective exclusive license territory may be ``worldwide'', and the field of use may be limited to ``development of devices for sale and services for high throughput parallel analysis and two dimensional analyses of molecules for all uses.''
Oral Dosage Form New Animal Drugs; Robenacoxib
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 Novartis Animal Health US, Inc. The NADA provides for the veterinary prescription use of robenacoxib tablets in cats for the control of postoperative pain and inflammation.
Federal Monitoring of Child and Family Service Programs; Request for Public Comment and Consultation Meetings
The Children's Bureau is interested in improving the process by which we review title IV-B and IV-E plan requirements. CB currently reviews a State's compliance through Child and Family Service Reviews (CFSRs). Following two rounds of CFSRs in every State and the passage of several amendments to Federal child welfare laws since the CFSRs began, we believe it is time to reassess how CB reviews title IV-B and IV-E programs through the CFSR and identify enhancements and system improvements we could make.
National Advisory Council for Healthcare Research and Quality: Request for Nominations for Public Members
42 U.S.C. 299c establishes a National Advisory Council for Healthcare Research and Quality (the Council). The Council is to advise the Secretary of HHS (Secretary) and the Director of the Agency for Healthcare Research and Quality (AHRQ) on matters related to activities of the Agency to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. Seven current members' terms will expire in November 2011. To fill these positions, we are seeking individuals who are distinguished: (1) In the conduct of research, demonstration projects, and evaluations with respect to health care; (2) in the fields of health care quality research or health care improvement; (3) in the practice of medicine; (4) in other health professions; (5) in representing the private health care sector (including health plans, providers, and purchasers) or administrators of health care delivery systems; (6) in the fields of health care economics, information systems, law, ethics, business, or public policy; and, (7) in representing the interests of patients and consumers of health care. 42 U.S.C. 299c(c)(2). Individuals are particularly sought with experience and success in activities specified in the summary above.
Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies Federal agencies of the Laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently certified Laboratories and Instrumented Initial Testing Facilities (IITF) is published in the Federal Register during the first week of each month. If any Laboratory/IITF's certification is suspended or revoked, the Laboratory/IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any Laboratory/IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.
Preparation for International Cooperation on Cosmetics Regulations; Public Meeting
The Food and Drug Administration (FDA) is announcing a public meeting entitled ``International Cooperation on Cosmetics Regulations (ICCR)Preparation for ICCR-5 Meeting in Paris, France'' to provide information and receive comments on the International Cooperation on Cosmetics Regulations (ICCR) as well as the upcoming meetings in Paris, France. 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 Paris, France scheduled on June 28 through July 1, 2011.
Early Retiree Reinsurance Program
This notice announces that CMS is exercising its authority under section 1102(f) of the Affordable Care Act to stop accepting applications for the Early Retiree Reinsurance Program, due to the availability of funds, as of May 5, 2011.
Government-Owned Inventions; Availability for Licensing
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.
Government-Owned Inventions; Availability for Licensing
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.
Medicare Program; Revisions to the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Suppliers Safeguards
This proposed rule would remove the definition of and modify requirements regarding ``direct solicitation;'' allow DMEPOS suppliers, including DMEPOS competitive bidding program contract suppliers, to contract with licensed agents to provide DMEPOS supplies unless prohibited by State law; remove the requirement for compliance with local zoning laws; and modify certain State licensing requirement exceptions.
Seeking Public Comment on Two Draft Chapters of the National Health Security Strategy Biennial Implementation Plan
To help the Nation achieve national health security and to implement the first quadrennial National Health Security Strategy (NHSS) of the United States of America (2009) and build upon the NHSS Interim Implementation Guide for the National Health Security Strategy of the United States of America (2009) the U.S. Government has drafted a NHSS Biennial Implementation Plan (BIP). This document is intended to describe the priority activities to occur during fiscal years 2011 and 2012 of implementation so that all sectors and segments of the Nation are working collectively and leveraging resources to achieve the same outcomes. The activities include responsible entities. The target audience for the BIP is the Nation (individuals, families, communities including all sectors and governments, states and the Federal Government). Two chapters (and respective appendices) of the draft BIP document which address (1) Strategic Objective 4, Foster Integrated, Scalable Health Care Delivery Systems; and (2) Strategic Objective 6, Promote and Effective Countermeasures Enterprise are submitted for public consideration and comment for a period of 14 calendar days at https:// www.phe.gov/nhss. These chapters are the final two to be provided for public consideration and comment; others were available in July 2010. The Office of the Assistant Secretary of Preparedness and Response (ASPR) within the Department of Health and Human Services (HHS) is submitting this document for public consideration as the lead agency in a broad interagency process to draft the implementation plan.
Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception From Informed Consent for Emergency Research; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception from Informed Consent for Emergency Research.'' This guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors in the development, conduct, and oversight of research involving FDA-regulated products (e.g., drugs, biological products, devices) in emergency settings when an exception from the informed consent requirements is requested under the Code of Federal Regulations (CFR). FDA determined that guidance is needed in interpreting and complying with these regulations, particularly in the areas of planning and conducting community consultation and public disclosure activities, and the establishment of informed consent procedures to be used when feasible. The guidance announced in this notice finalizes the draft guidance of the same title, dated July 2006.
Marilyn A. Mehlmauer: Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Marilyn Mehlmauer, MD 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. Mehlmauer 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. Mehlmauer was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Mehlmauer failed to respond. Dr. Mehlmauer's failure to respond constitutes a waiver of her right to a hearing concerning this action.
Maja S. Ruetschi: Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Maja S. Ruetschi, MD for 5 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. Ruetschi 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. Ruetschi was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Ruetschi failed to respond. Dr. Ruetschi's failure to respond constitutes a waiver of her right to a hearing concerning this action.
Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting; Reopening of the Comment Period
The Food and Drug Administration (FDA) is reopening until May 2, 2011, the comment period for the notice announcing a meeting of the Molecular and Clinical Genetics Panel (the panel) of the Medical Devices Advisory Committee that published in the Federal Register of February 7, 2011 (76 FR 6623). In the notice, FDA requested public comment regarding the March 8 and 9, 2011, meeting of the panel to discuss and make recommendations on scientific issues concerning direct to consumer (DTC) genetic tests that make medical claims. FDA is reopening the comment period to update comments and to receive any new information.
Guidance for Industry on Postmarketing Studies and Clinical Trials-Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Postmarketing Studies and Clinical TrialsImplementation of Section 505(o)(3) 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 FD&C Act) authorizing FDA to require certain postmarketing studies and clinical trials for prescription drugs approved under the FD&C Act and biological products approved under the Public Health Service Act (the PHS Act). This 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.
Best Pharmaceuticals for Children Act (BPCA) Priority List of Needs in Pediatric Therapeutics
The National Institutes of Health (NIH) hereby announces the Best Pharmaceuticals for Children Act (BPCA) Priority List of Needs in Pediatric Therapeutics for 2011. The BPCA seeks to improve the level of informationin scientific publications and on the labelabout pharmaceuticals used to treat children. The BPCA requires that the NIH identify the drugs of highest priority for study in pediatric populations and publish a list of drugs/needs in pediatric therapeutics. This notice fulfills the requirement to publish that list.
Request for Public Comment on Proposed Funding Opportunity Announcement for Special Initiative Concerning the Assets for Independence Program
In FY 2011, the Office of Community Services (OCS) will coordinate with the Administration on Native Americans (ANA) to implement the Native Asset Building Initiative, through which the two offices will support Tribes and Native organizations in planning and implementing comprehensive asset-building projects. The initiative will feature special grants through the Assets for Independence (AFI) program. These grants will be in addition to the annual AFI grants that OCS will award in FY 2011. In contrast to the annual awards, though, the eligibility criteria to be listed for these AFI grants in the ``Native Asset Building Initiative'' will vary from the annual AFI awards' eligibility criteria. This is because the criteria used to determine eligibility for these special initiative awards will be more consistent with those used to determine eligibility in the ANA grant program with which OCS is coordinating. Consequently, the eligibility for the special AFI grants will be limited to Native 501(c)(3) non- profits serving Native Americans; Federally recognized Tribal governments or Alaska Native Villages, as defined in the Alaska Native Claims Settlement Act, that are joint applicants with a 501(c)(3) Native non-profit organization; and Native non-profit organizations designated by the Secretary of the Treasury as Community Development Financial Institutions and Native non-profit credit unions designated by the National Credit Union Administration as low-income credit unions that demonstrate a collaborative relationship with a local community based organization whose activities are designed to address poverty and the needs of community members for economic independence and stability. Other entities will not be eligible for awards under this initiative, but will continue to be eligible for awards under the annual AFI funding opportunity announcement that was published issued for FY 2011 through FY 2013 on February 24, 2011 on https://www.acf.hhs.gov/grants/ open/foa/view/HHS-2011-ACF-OCS-EI-0137. It is estimated that OCS will award up to 10 AFI program grants under Native Asset Building Initiative, with overall funding of approximately $2,500,000 toward the initiative. It is anticipated that each recipient of these special AFI grants will also receive a separate ANA award for their project. In addition to these special AFI awards, we estimate that $15,000,000 in grants will be awarded in FY 2011 under the annual AFI funding opportunity announcement published on February 24, 2011.
Announcement of Award
The Administration for Children and Families (ACF), Children's Bureau (CB) announces the award of a single-source program expansion supplement grant to the Regents of the University of Michigan at Anne Arbor, MI, Quality Improvement Center on the Representation of Children in the Child Welfare System (QIC-ChildRep), to support additional and enhanced evaluation of the QIC-ChildRep research and demonstration projects. The Regents of the University of Michigan was awarded a cooperative agreement in FY 2009 as the result of a competition to establish the QIC-ChildRep. The purpose of the QIC-ChildRep is to improve the quality of legal representation for children and youth in child welfare cases so that States and Tribes achieve the best safety, permanency and well- being outcomes for children and youth. Under the cooperative agreement, the QIC-ChildRep develops knowledge about effective strategies to provide competent and effective representation for children and youth in child welfare cases, promotes the certification of lawyers as specialist is child welfare, develops and implements child representation research and demonstration projects to promote evidence- based, evidence-informed practice improvements and effective child representation, establishes and maintains a national information sharing network to disseminate information on promising practices; evaluates the impact of selected projects implementing the child representation models on outcomes for children and families who have competent and effective child representation, and identifies barriers and recommends need changes in laws, policies, procedures and/or practice. The supplemental funds will be used to provide additional training, technical assistance, and support to each research and demonstration site to fully implement and maintain rigorous on-site and cross-site evaluation plans.
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