Department of Health and Human Services April 2011 – Federal Register Recent Federal Regulation Documents
Results 201 - 250 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.
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