Department of Health and Human Services August 2011 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 349
Prospective Grant of Exclusive License: Conjugate Vaccines Against B. anthracis
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of an exclusive license to practice the following invention as embodied in the following patent applications: (1) E-146-2004/0, Purcell et al., ``Monoclonal Antibodies That Neutralize Anthrax Protective Antigen (PA) Toxin'', U.S. Patent Application Number 60/ 639,074, filed on December 22, 2004, PCT Application Number PCT/US2005/ 046/790, filed on December 21, 2005, and U.S. Patent Application Number 11/793,735, filed on December 8, 2009, (2) E-123-2007/0, Purcell et al., ``Monoclonal Antibodies that Neutralize B. anthracis Protective Antigen (PA), Lethal Factor (LF) and Edema Factor (EF)'', U.S. Patent Application Number 60/903,022, filed on February 23, 2007, PCT Application Number PCT/US2008/054609, filed on February 21, 2008, and U.S. Patent Application Number 12/528,427, filed on August 24, 2009, and European Patent Application Number 08730415.0, filed on September 23, 2009, (3) E-125-2008/0, Purcell et al., ``Monoclonal Antibodies That React With the Capsule of Bacillus anthracis'', U.S. Patent Application Number 61/116,222, filed on November 19, 2008, PCT Application Number PCT/US2009/065198, filed on November 19, 2009, and U.S. Patent Application Number 13/130,044, filed on May 18, 2011, (4) E-343-2002/0, Schneerson et al., ``gammaPGA Conjugates for Eliciting Immune Responses Directed Against Bacillus anthracis and Other Bacilli'', U.S. Patent Application Number 60/476,598, filed on June 5, 2003, PCT Application Number PCT/US2004/17736, filed on June 4, 2004, U.S. Patent Application Number 10/559,825, filed December 2, 2005, now U.S. Patent Number 7,803,386, European Patent Application Number 04754360.8, filed June 4, 2004, Canadian Patent Application Number 2,528,067, filed June 4, 2004, and Australian Patent Application Number 2004252091, filed June 4, 2004, now Australian Patent Number 2004252091, and (5) E-040-2005/0, Schneerson et al., ``Methods for Preparing Immunogenic Conjugates'', U.S. Patent Application Number 11/ 005,851, filed on December 6, 2004, now U.S. Patent Number 7,625,736, PCT Application Number PCT/US2005/19678, filed June 3, 2005, European Patent Application Number 05758048.2, filed June 3, 2005, now European Patent Number 1765394 (rights were validated in Germany (Patent Number 602005015855), France (Patent Number 1765394), Great Britain (Patent Number 1765394), and Ireland (Patent Number 1765394)), Indian Patent Application Number 7703/DELNP/2006, filed June 3, 2005, Chinese Patent Application Number 200580018108.2, filed June 3, 2005, Australian Patent Application Number 2005249571, filed June 3, 2005, now Australian Patent Number 2005249571, Canadian Patent Application Number 2,568,364, filed June 3, 2005, and U.S. Patent Application Number 12/ 582,420, filed October 20, 2009, to Biologics Resources LLC, having a place of business in Boyds, Maryland, United States of America. The patent rights in these inventions have been assigned to the United States of America.
Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee; Cancellation of the September 21, 2011 Meeting
This notice announces the cancellation of the September 21, 2011 public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') that was published in the July 22, 2011 Federal Register (76 FR 44011 through 44012). This notice also announces a public meeting on Wednesday, March 21, 2012. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services can be covered under the Medicare statute. This meeting will focus on the currently available evidence regarding antivascular endothelial growth factor (anti-VEGF) treatment of diabetic macular edema (DME). This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).
Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee-November 9, 2011
This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, November 9, 2011. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services can be covered under the Medicare statute. This meeting will focus on the use of electrocardiogram (ECG) based signal analysis technologies to detect myocardial ischemia or coronary artery disease. This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).
Meeting of the National Vaccine Advisory Committee
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public. Preregistration is required for both public attendance and comment. Individuals who wish to attend the meeting and/or participate in the public comment session should register at https://www.hhs.gov/nvpo/nvac, e-mail nvpo@hhs.gov or call 202-690-5566 and provide name, organization, and e-mail address.
New Animal Drugs; Ampicillin Trihydrate, Bacitracin Methylene Disalicylate, Flunixin, Gonadotropin Releasing Factor Analog-Diphtheria Toxoid Conjugate, Methylprednisolone, and Sulfamethazine
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect revised human food safety warnings on dosage form new animal drug product labeling that have not been codified. The regulations are also being amended to correct the wording of certain other conditions of use, to correct minor errors, and to revise some sections to reflect a current format. These actions are being taken to comply with the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and to improve the accuracy and readability of the regulations.
Bundled Payments for Care Improvement Initiative: Request for Applications
This notice announces a request for applications for organizations to participate in one or more of the initial four models under the Bundled Payments for Care Improvement initiative beginning in 2012.
Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors
This final rule implements changes to the regulations on the Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors. Since the promulgation of the regulations in 1995, biomedical and behavioral research and the resulting interactions among government, research Institutions, and the private sector have become increasingly complex. This complexity, as well as a need to strengthen accountability, led to changes that expand and add transparency to Investigators' disclosure of Significant Financial Interests (SFIs), enhance regulatory compliance and effective institutional oversight and management of Investigators' financial conflicts of interests, as well as increase the Department of Health and Human Services' (HHS) compliance oversight.
Workshop: Advancing Research on Mixtures; New Perspectives and Approaches for Predicting Adverse Human Health Effects
The NIEHS is hosting a workshop entitled ``Advancing Research on Mixtures: New Perspectives and Approaches for Predicting Adverse Human Health Effects'' on September 26-27, 2011 at the Sheraton Chapel Hill, Chapel Hill, NC. This workshop is organized to include plenary sessions and small group breakout sessions on specific topics. It is open to the public to attend as observers. For more information and to register for this workshop, please visit https://tools.niehs.nih.gov/ conferences/dert/mixtures/. The deadline to register for this workshop is Monday, September 12, 2011. Registration is limited to 85 observers based on available space.
Prospective Grant of Exclusive License: Devices for Clearing Mucus From Endotracheal Tubes
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of a worldwide exclusive license, to practice the invention embodied in: HHS Ref. No. E-061-2004/0 ``Mucus Shaving Apparatus for Endotracheal Tubes''; U.S. Patent 7,051,737 to EndOclear, LLC, a company incorporated under the laws of the State of Michigan having its headquarters in Petoskey, Michigan. The United States of America is the assignee of the rights of the above inventions. The contemplated exclusive license may be granted in a field of use limited to devices for clearing mucus from endotracheal tubes.
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 for Parts C and D and may make recommendations to the Medicare Trustees on how the Trustees might more accurately estimate health spending in the short run. They will also discuss the long term (75 year) projection methods and assumptions in projecting the National Health Expenditures and Medicare expenditures. 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.
Draft Guidance for Industry on Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or Prevention; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or Prevention.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment or prevention of neglected diseases of the developing world. Specifically, this guidance addresses FDA's current thinking regarding the overall drug development program for the treatment or prevention of neglected tropical diseases (NTDs), including clinical trial designs and internal review standards to support approval of drugs.
2011 Technology Transfer Summit North America Conference
The NIH Office of Technology Transfer extends invitations to attend the 2011 Technology Transfer Summit North America Conference.
Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability; Correction
The Food and Drug Administration (FDA) is correcting a notice of availability that appeared in the Federal Register of August 4, 2011 (76 FR 47211). The Agency 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. The August 4, 2011, 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. The document was published with an error. This document corrects that error.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Comparing Nutrition Knowledge, Attitude, and Behavior Among English-Dominant Hispanics, Spanish-Dominant Hispanics, and Other Consumers
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.
International Conference on Harmonisation; Guidance on E2F Development Safety Update Report; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``E2F Development Safety Update Report.'' 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 the format, content, and timing of a development safety update report (DSUR) for an investigational drug. The DSUR will serve as a common standard for periodic reporting on drugs under development (including marketed drugs that are under further study) among the ICH regions. The DSUR can be submitted in the United States in place of an annual report for an investigational new drug application (IND). The harmonized DSUR is intended to promote a consistent approach to annual clinical safety reporting among the ICH regions and enhance efficiency by reducing the number of reports generated for submission to the regulatory authorities.
Request for Information: Announcement of Carcinogen and Recommended Exposure Limit (REL) Policy Assessment
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) intends to review its approach to classifying carcinogens and establishing recommended exposure limits (RELs) for occupational exposures to hazards associated with cancer. As part of this effort, NIOSH is requesting initial input on these issues (including answers to the 5 questions in the following section), to be submitted to the NIOSH Docket number 240, for a comment period lasting through September 22, 2011. This information will be taken under consideration and used to inform NIOSH efforts to assess and document its carcinogen policy and REL policy regarding occupational hazards associated with cancer. NIOSH has also created a new NIOSH Cancer and REL Policy Web Topic Page [see https://www.cdc.gov/niosh/topics/cancer/policy.html] to provide additional details about this effort and progress updates. Public Comment Period: Comments must be received by September 22, 2011.
Notice of Intent To Award Affordable Care Act Funding, DP-09-001
This notice provides public announcement of CDC's intent to fund Approved cooperative agreement applications previously received and competed in response to CDC Funding Opportunity, RFA-DP-09-001, ``Health Promotion and Disease Prevention Research Centers (U48).'' It is the intent of CDC to fund the applications with Patient Protection Affordable Care Act (ACA), Section 4002, appropriations. CFDA Number 93.542 is the ACA-specific CFDA number for this initiative.
Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Product Reporting Violation Form
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection of information contained in FDA's Tobacco Product Reporting Violation Form.
Arthritis Advisory Committee; Notice of Postponement of Meeting
The Food and Drug Administration (FDA) is postponing the Arthritis Advisory Committee meeting scheduled for September 13, 2011. This meeting was announced in the Federal Register of July 19, 2011 (76 FR 42715). The postponement is due to the fact that the Agency recently received submissions from some of the investigational new drug (IND) application holders for anti-nerve growth factor (Anti-NGF) antibody drug products that contain large quantities of new information that will require additional time for Agency review prior to the advisory committee meeting.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Data To Support Communications Usability Testing, as Used by the Food and Drug Administration
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.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
