Department of Health and Human Services 2005 – Federal Register Recent Federal Regulation Documents
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Prospective Grant of Exclusive License: Treatment of Cardiovascular Conditions With Nitrite Therapy
This 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 invention embodied in PCT patent applications PCT/US2004/21985 and PCT/US2004/22232, filed July 9, 2004, both entitled ``Use of Nitrite Salts for the Treatment of Cardiovascular Conditions'' [HHS Reference Number: E-254-2003/2-3-PCT- 01], to Hope Medical Enterprises, Inc., dba Hope PharmaceuticalsTM, an Arizona S-Corporation having a principle place of business in Scottsdale, Arizona. The field of use may be limited to the use of nitrite salts for the treatment of cerebral vasospasm following subarachnoid hemorrhage and/or cardiovascular conditions. The United States of America is an assignee of the patent rights in these inventions.
Prospective Grant of Exclusive License: Software for Predicting Molecular Properties and Pathogen Detection
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, is contemplating the grant of an exclusive worldwide license to practice the invention embodied in E- 169-2000/0 ``Drift Compensation Method for Fingerprint Spectra,'' U.S. Patent Application No. 09/975,530 filed October 10, 2001; E-297-2001/0 ``Methods For Predicting Properties of Molecules,'' U.S. Patent Application No. 10/383,602 filed March 7, 2003; and E-017-2003/0 ``Improved Pattern Recognition Of Whole Cell Mass Spectra Via Separation Of Specific Charge States,'' U.S. Patent Application No. 10/ 863,745 filed June 7, 2004; to Litmus, LLC an Arkansas corporation having its headquarters in Little Rock, Arkansas. The United States of America is the assignee of the patent rights of the above inventions. The contemplated exclusive license may be granted in the field of providing software solutions for pathogen detection and for predicting molecular properties.
Prospective Grant of Exclusive License: Fusion Proteins Comprising Circularly Permuted Ligands
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, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in United States Patent No. 4,892,827, issued on January 9, 1990, entitled ``Recombinant Pseudomonas Exotoxin: Construction Of An Active Immunotoxin With Low Side Effects'' [E-385-1986/0-US-01]; U.S. Patent No. 5,635,599, issued on June 3, 1997, entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E-047-1994/0-US-01]; PCT Patent Application No. PCT/US95/04468, filed April 6, 1995, entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E-047-1994/ 0-PCT-02]; Switzerland Patent No. 0754192, issued on January 29, 2003, entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E- 047-1994/0-CH-03]; Spain Patent No. 0754192, issued on January 29, 2003, entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E-047-1994/0-ES-04]; United Kingdom Patent No. 0754192, issued on January 29, 2003, entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E-047-1994/0-GB-05]; Italy Patent No. 0754192, issued on January 29, 2003, entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E-047-1994/0-IT-06]; Luxembourg Patent No. 0754192, issued on January 29, 2003, entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E-047-1994/ 0-LU-07]; Netherlands Patent No. 0754192, issued on January 29, 2003, entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E- 047-1994/0-NL-09]; German Patent No. 0754192, issued on January 29, 2003, entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E-047-1994/0-DE-10]; Austria Patent No. 0754192, issued on January 29, 2003, entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E-047-1994/0-AT-11]; Australia Patent No. 694211, issued on November 5, 1998, entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E-047-1994/0-AU-12]; Belgium Patent No. 0754192, issued on January 29, 2003, entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E-047-1994/0-BE-13]; Canada Patent No. 2187283, filed on April 6, 1995, entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E-047-1994/0-CA-14]; European Patent No. 0754192, issued on January 29, 2003, entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E-047-1994/0-EP-15]; France Patent No. 0754192, issued on January 29, 2003, entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E-047-1994/ 0-FR-16]; Ireland Patent No. 0754192, issued on January 29, 2003, entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E- 047-1994/0-IE-17]; Liechtenstein Patent No. 0754192, issued on January 29, 2003, entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E-047-1994/0-LI-18]; and U.S. Patent No. 6,011,002, issued on January 4, 2000, entitled ``Circularly Permutated Ligands And Circularly Permuted Chimeric Molecules'' [E-047-1994/1-US-01] to Protox Therapeutics, Inc., which has offices in Vancouver, British Columbia, Canada. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to the use of Interleukin-4/cytotoxin fusion proteins for the treatment of cancer.
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.
Prospective Grant of Exclusive License: Implants for Sustained Ocular Therapeutic Agent Delivery
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, is contemplating the grant of an exclusive worldwide license to practice the invention embodied in E- 241-1999/0, ``Ocular Therapeutic Agent Delivery Devices And Methods For Making And Using Such Devices;'' U.S. Patent 6,713,081 issued March 30, 2004 and expires March 15, 2021; U.S. Patent Application 10/471,468 filed September 12, 2004; and European Patent Application 02723446.7 filed March 14, 2002; to Lux Biosciences, a Delaware corporation having a principle place of business in Jersey City, New Jersey. The United States of America is the assignee of the patent rights of the above inventions. The contemplated exclusive license may be granted in the field of ocular cyclosporine A delivery for the treatment of graft-versus-host- disease-associated dry eye and Sj[ouml]gren's Syndrome.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees
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.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Regulations Under the Federal Import Milk Act
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Regulations Under the Federal Import Milk Act'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Cosmetic Product Voluntary Reporting Program
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Cosmetic Product Voluntary Reporting Program'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Mammography Quality Standards Act Final Regulations; Modifications and Additions to Policy Guidance Help System #9
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.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Devices; Humanitarian Use Devices
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Medical Devices; Humanitarian Use Devices'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Public Notice
The Centers for Disease Control and Prevention (CDC), National Center for Infectious Disease (NCID), Division of Bacterial and Mycotic Diseases (DBMD) and the National Immunization Program, Epidemiology and Surveillance Division through its component Branches have lead technical responsibility for research, development and evaluation of diagnostic tools for pertussis and application of these to epidemiologic studies of pertussis. CDC uses epidemiologic, laboratory, clinical, and biostatistical sciences to control and prevent vaccine preventable infectious diseases. CDC also conducts applied research in a variety of settings, and translates the findings of this research into public health practice. CDC is seeking to evaluate commercial products, or products in development, for in vitro serological diagnosis of pertussis. Specifically these should include tests to detect anti-pertussis toxin antibodies in infected and vaccinated individuals. The tests should be based on standardized reagents commonly used in the field (such as FDA Reference Serum Standard Lot 3 or equivalents). Products will be evaluated in CDC and collaborating laboratories and if appropriate, may be used in epidemiologic validation studies. Data obtained from this comparative analysis may be used by CDC in making recommendations and decisions for diagnosis of pertussis in the public health setting. Interested organizations that may have candidate products are invited to submit documentation for CDC to assess whether the offered product(s) are at a sufficient stage of development to be included in this comparative analysis. As a minimum, submitted information should be sufficient for CDC to determine the following for each candidate product: (a) Product package insert or detailed instructions for use; (b) Detailed information to determine if the product is calibrated to a recognized standard; and (c) Preliminary data demonstrating suitability for validation studies. Organizations that have products selected by CDC for this comparative analysis will be required to enter into an appropriate agreement prior to the transfer of any material to CDC. Sample agreements may be viewed at the following Web site: https://www.cdc.gov/ od/ads/techtran/forms.htm. All information submitted to CDC will be kept confidential as allowed by relevant federal law, including the Freedom of Information Act (5 U.S.C. 552) and the Trade Secrets Act (18 U.S.C. 1905). Only information submitted within thirty days of publication of this notice will be reviewed to determine if the offered product(s) will be acceptable for possible inclusion in this comparative analysis. Responses are preferred in electronic format and can be e-mailed to the attention of Michael J. Detmer at MDetmer@cdc.gov. Mailed responses can be sent to the following address: Michael J. Detmer, Division of Bacterial and Mycotic Diseases, National Center for Infectious Diseases, Centers for Disease Control and Prevention, 1600 Clifton Rd., NE., Mail Stop C-09, Atlanta, GA 30333.
Assistant Secretary for Planning & Evaluation Medicaid Program; Meeting of the Medicaid Commission-January 24-26, 2006
This notice announces a public meeting of the Medicaid Commission. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)). The Medicaid Commission will advise the Secretary on ways to modernize the Medicaid program so that it can provide high-quality health care to its beneficiaries in a financially sustainable way.
Privacy Act System of Records
Pursuant to the provisions of the Privacy Act of 1974, as amended, 5 U.S.C. 552a(e)(4), the IHS has amended and is publishing the proposed alteration of a system of records, System No. 09-17-0001, ``Medical, Health and Billing Records.'' The amended and altered system of records makes only administrative edits and revisions as necessary.
Training Program for Regulatory Project Managers; Information Available to Industry
The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program (the Site Tours Program). The purpose of this notice is to invite pharmaceutical companies interested in participating in this program to contact CDER.
Animal Drug User Fee Act; Public Meeting
The Food and Drug Administration (FDA) is announcing a public meeting on the Animal Drug User Fee Act (ADUFA) to seek public comments relative to the program's overall performance and reauthorization as directed by Congress. Date and Time: The public meeting will be held on February 24, 2006, from 9 a.m. to 5 p.m. Requests to make a presentation at the meeting must be received by February 10, 2006. Written comments regarding this meeting may be made by March 26, 2006, to the Division of Dockets Management (see Addresses). Location: The meeting will be held at the DoubleTree Hotel, Plaza II and III, 1750 Rockville Pike, Rockville, MD 20852. Registration is not required to attend the meeting. Parking is limited, so we recommend arriving by subway (Metro rail) if possible. The DoubleTree Hotel is accessible from the Metro rail's red line at the Twinbrook station.
Determination That DECADRON (Dexamethasone) Tablets, 1.5 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that DECADRON (dexamethasone) tablets, 1.5 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for dexamethasone tablets, 1.5 mg.
Designation of New Animal Drugs for Minor Uses or Minor Species; Reopening of the Comment Period
The Food and Drug Administration (FDA) is reopening until January 27, 2006, the comment period for the proposed rule published in the Federal Register of September 27, 2005 (70 FR 56394), proposing implementing regulations for designation of new animal drugs for minor uses and minor species under section 573 of the Federal Food, Drug, and Cosmetic Act (the act). FDA is reopening the comment period to update comments and to receive any new information.
Food Labeling: Ingredient Labeling of Dietary Supplements That Contain Botanicals; Withdrawal
The Food and Drug Administration (FDA) published in the Federal Register of August 28, 2003 (68 FR 51693), a direct final rule to amend the regulation on the designation of ingredients in dietary supplements by incorporating by reference the most recent editions of the references Herbs of Commerce and the International Code of Botanical Nomenclature. The direct final rule also would have added a sentence to this regulation codifying the requirements contained in the Farm Security and Rural Investment Act of 2002 (Public Law 107-171) that restrict the use of the term ``ginseng'' as a common or usual name to botanicals within the genus ``Panax'' and limiting the use of the term ``ginseng'' to labeling and advertising of herbs or herbal ingredients classified within the genus ``Panax.'' FDA is withdrawing the direct final rule because the agency received significant adverse comment.
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at the Mallinckrodt Chemical Works, Destrehan Street Facility, in St. Louis, Missouri, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On October 14, 2005, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
Designation of a Class of Employees for Addition to the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice of a decision to designate a class of employees at the Linde Ceramics Plant, in Tonawanda, New York as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On December 8, 2005, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Decision To Evaluate a Petition To Designate a Class of Employees at Chapman Valve Co., Indian Orchard, Massachusetts, To Be Included in the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at the Chapman Valve Co., in Indian Orchard, Massachusetts, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Chapman Valve Co. Location: Indian Orchard, Massachusetts. Job Titles and/or Job Duties: Various. Period of Employment: From 1948 through 1949 and from 1991-1995 (DOE Remediation).
Employment and Training Administration Determination Concerning a Class of Employees Considered for Addition to the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice of a decision that a class of employees at the National Bureau of Standards, Van Ness Street, Washington, DC, do not meet the statutory criteria for addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA). On December 8, 2005, the Secretary of HHS determined, based on the decision by the Department of Energy to remove the site from the list of covered facilities, that the following class of employees do not meet the statutory requirements for covered employees under EEOICPA and thus do not meet the statutory requirements for the SEC:
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reclassification Petitions for Medical Devices
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.
Guidance for Industry: Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 2); Availability
The Food and Drug Administration (FDA) is announcing the availability of a revised guidance document entitled ``Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 2).'' The guidance explains, using a question and answer format, FDA's current thinking on a number of issues related to the regulation of food allergens, including implementation of the Food Allergen Labeling and Consumer Protection Act (FALCPA).
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