Department of Health and Human Services August 3, 2005 – Federal Register Recent Federal Regulation Documents
Results 1 - 25 of 25
Agency Information Collection Activities; Proposed Collection; Comment Request; Importer's Entry Notice
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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection provisions for the Importer's Entry Notice.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Temporary Marketing Permit Applications; Correction
The Food and Drug Administration is correcting a notice that appeared in the Federal Register of July 26, 2005 (70 FR 43159). The document announced Office of Management Budget approval for State petitions for exemption from preemption. The document was published with an incorrect title and an incorrect docket number. This document corrects those errors.
Prospective Grant of Exclusive License: Adaphostin as a Novel Cancer Therapy
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: 1. E-013-1998/0-US-01, ``Disubstituted Lavendustin A Analogs and Pharmaceutical Compositions Comprising the Analogs'', by Venkatachala Narayanan, Edward Sausville, Kaur Gurmeet, Varma Ravi, application number 60/076,330 (filed February 27, 1998); 2. E-013-1998/0-PCT-02, ``Disubstituted Lavendustin A Analogs and Pharmaceutical Compositions Comprising the Analogs'', by Venkatachala Narayanan, Edward Sausville, Kaur Gurmeet, Varma Ravi, application number PCT/US99/04002 (filed February 24, 1999);
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 an Exclusive License: Therapeutics for the Treatment of Kidney Cancer and Thyroid Neoplasms
This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), announces that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in 1. E-199-2002/0-US-01, ``Treatment Method and Therapeutic Agent of Kidney Cancer'', by Susan Bates, and Yoshinori Naoe, Pat. Application No. 60/369,868 (filing date April 5, 2002); 2. E-199-2002/0-PCT-02, ``Treatment Method and Therapeutic Agent of Kidney Cancer'', by Susan Bates, and Yoshinori Naoe, Pat. Application No. PCT/US03/03823 (filing date March 27, 2003); 3. E-199-2002/0-US-04, ``Depsipeptide for Therapy of Kidney Cancer'', by Susan Bates, and Yoshinori Naoe, Pat. Application No. 10/ 508,958 (filing date October 5, 2004); 4. E-199-2002/0-JP-08, ``Depsipeptide for Therapy of Kidney Cancer'', by Susan Bates, and Yoshinori Naoe, Pat. Application No. 20003581847 (filing date October 5, 2004); 5. E-199-2002/0-EP-05, ``Depsipeptide for Therapy of Kidney Cancer'', by Susan Bates, and Yoshinori Naoe, Pat Application No.037155033-2107 (filing date October 8, 2004); 6. E-286-2000/0-US-01, ``Histone Deacetylase Inhibitors in Diagnosis and Treatment of Thyroid Neoplasms'', by Tito Fojo and Susan Bates, Pat. Application No. 60/260,733 (filing date January 10, 2001); 7. E-286-2000/0-US-02, ``Histone Deacetylase Inhibitors in Diagnosis and Treatment of Thyroid Neoplasms'', by Tito Fojo and Susan Bates, Pat. Application No. PCT/US02/0714 (filing date January 9, 2001); 8. E-286-2000/0-EP-03, ``Histone Deacetylase Inhibitors in Diagnosis and Treatment of Thyroid Neoplasms'', by Tito Fojo and Susan Bates, Pat. Application No. 02718823.4 (filing date January 9, 2001); 9. E-286-2000/0-AU-04, ``Histone Deacetylase Inhibitors in Diagnosis and Treatment of Thyroid Neoplasms'', by Tito Fojo and Susan Bates, Pat. Application No. 2002249938 (filing date January 9, 2001); 10. E-286-2000/0-CA-04, ``Histone Deacetylase Inhibitors in Diagnosis and Treatment of Thyroid Neoplasms'', by Tito Fojo and Susan Bates, Pat. Application No. 2434269 (filing date January 9, 2001); 11. E-286-2000/0-US-07, ``Histone Deacetylase Inhibitors in Diagnosis and Treatment of Thyroid Neoplasms'', by Tito Fojo and Susan Bates, Pat. Application No. 10/250,320 (filing date June 26, 2003); 12. E-286-2000/0-JP-05, ``Histone Deacetylase Inhibitors in Diagnosis and Treatment of Thyroid Neoplasms'', by Tito Fojo and Susan Bates, Pat. Application No. 2002-556736 (filing date July 10, 2003)
Prospective Grant of an Exclusive License: Anti-Cancer Vaccines
This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), announces that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in U.S. Patent Application No. 60/498,238, filed August 26, 2003, entitled ``Anti- cancer Vaccines'' (E-179-2004/0-US-01); U.S. Patent Application No. 10/ 926,852, filed August 26, 2004, entitled ``Anti-cancer Vaccines'' (E- 179-2004/0-US-03); and PCT Application No. PCT/US04/27790, filed August 26, 2004, entitled ``Anti-cancer Vaccines'' (E-179-2004/0-PCT-02), to Vaccine Company, having a place of business in Carmel-by-the-Sea, California. The patent rights in these inventions have been assigned to the United States of America and MD Anderson Cancer Center (Part of the University of Texas System). The prospective exclusive license territory may be worldwide, and the field of use may be limited to development and sale of diagnostic and pharmaceutical products useful in diagnosis and treatment of myeloid neoplasms.
Prospective Grant of Exclusive License: Treatment of Inflammatory Diseases Using Ghrelin
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 license to practice the invention embodied in U.S. provisional patent application, S/N 60/569,819 filed May 11, 2004, entitled ``Methods for Inhibiting Proinflammatory Cytokine Expression Using Ghrelin'' and converted to PCT on May 11, 2005 (E-016-2004/0-PCT- 02), [Inventors: Vishwa D. Dixit, Dennis D. Taub, Eric Schaffer, and Dzung Nguyen (NIA)], to Gastrotech Pharma (hereafter Gastrotech), having a place of business in Copenhagen, Denmark. The patent rights in these inventions have been assigned to the United States of America.
Critical Path Initiative; Developing Prevention Therapies; Planning of Workshop
The Food and Drug Administration (FDA) is planning a 2-day workshop to explore approaches and potential obstacles to developing drugs, disease biomarkers, medical devices, and vaccines to prevent or reduce the risk of illness. The agency plans to hold the workshop as part of its Critical Path Initiative. Speakers at the workshop will be asked to discuss the challenges in developing chemoprevention therapies (i.e., prevention therapies other than lifestyle changes, dietary supplements, or dietary choices that could reduce the risk of certain illnesses such as cancer, diabetes, and obesity). Because prevention of illness is widely recognized to be an important goal and the possible scope of this workshop is very broad, FDA welcomes comments related to the scope of this workshop.
Request for Public Comment: 60-Day Proposed Information Collection: Final Rule To Implement Title V of the Tribal Self-Governance Amendments of 2000
The Department of Health and Human Services (DHHS), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) (44 U.S.C. 3506(c)(2)(A)). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Indian Health Service (IHS) is providing a 60- day advance opportunity for public comment on a proposed extension of current information collection activity to be submitted to the Office of Management and Budget for review. Proposed Collection: Title: 0917-0026, ``Final Rule to Implement Title V of the Tribal Self-Governance Amendments of 2000''. Type of Information Collection Request: Extension, without revision, of currently approved information collection, 0917-0026, ``Final Rule to Implement Title V of the Tribal Self-Governance Amendments of 2000''. Form Number: None. Forms: None. Need and Use of Information Collection: The ``Tribal Self-Governance Amendments of 2000'', Pub. L. 106-206 (the act), repeals Title III of the Indian Self-Determination Act, Pub. L. 93-638, as amended, (ISDA) and enacts Title V that established a permanent Self-Governance program within DHHS. Thus, Indian and Alaska Native Tribes are now able to compact for the operation, control, and redesign of various IHS activities on a permanent basis. The final rule has been negotiated among representatives of Self-Governance and non- Self-Governance Tribes and the DHHS. The final rule included provision governing how DHHS/IHS carries out its responsibility to Indian Tribes under the Act and how Indian Tribes carry out their responsibilities under the Act. As required by section 517(b) of the Act, the Department has developed this final rule with active Tribal participation of Indian Tribes, inter-Tribal consortia, Tribal organizations and individual Tribal members, using the guidance of the Negotiated Rulemaking Act, 5 U.S.C. 561 et seq. Health status reporting requirements will be negotiated on an individual Tribal basis and included in individual compacts of funding agreements. Response to the data collection continues to be voluntary; however, submission of the data is essential to participation in the Tribal Self-Governance process. Self-Governance Tribes have the option of participating in a voluntary national uniform data collection effort with the IHS. The department is seeking continued OMB approval of the collection of information identified in the following sections of regulations: subpart CSelection of Tribes for Participation in Self-Governance, subpart D and ECompact and Funding Agreement, subpart NConstruction Projects, and Subpart P Appeals. Affected Public: Individual Tribes. Type of Respondents: Tribal representatives. The table below provides the estimated burden hours for this information collection:
Request for Public Comment: 60-Day Proposed Information Collection: Indian Health Service Loan Repayment Program
The Department of Health and Human Services, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) (44 U.S.C. 3506(c)(2)(A)). This program helps to ensure that requested date can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Indian Health Service (IHS) is providing a 60-day advance opportunity for public comment on a proposed extension of current information collection activity to be submitted to the Office of Management and Budget for review. Proposed Collection: Title: 0917-0014, ``Indian Health Service Loan Repayment Program.'' Type of Information Collection Request: Extension, without revision, of currently approved information collection, 0917- 0014, ``Indian Health Service Loan Repayment Program.'' Form Number: None. Forms: The IHS Loan Repayment Program Information Booklet contains the instructions and the application formats. Need and Use of Information Collection: The IHS Loan Repayment Program (LRP) identifies health professionals with pre-existing financial obligations for education expenses that meet program criteria and who are qualified and willing to serve at, often remote, IHS health care facilities. Under the program, eligible health professionals sign a contract under which the IHS agrees to repay part or all of their indebtedness for professional training education. In exchange, the health professionals agree to serve for a specified period of time in IHS health care facilities. Eligible health professionals that wish to apply must submit an application to participate in the program. The application requests personal, demographic and educational training information, including information on the educational loans of the individual for which repayment is being requested (i.e., date, amount, account number, purpose of each loan, interest rate, the current balance, etc.). The data collected is needed and used to evaluate applicant eligibility; rank and prioritize applicants by speciality; assign applicants to IHS health care facilities; determine payment amounts and schedules for paying the lending institutions; and to provide data and statistics for program management review and analysis. Affected Public: Individuals and households. Type of Respondents: Individuals. The table below provides the estimated burden hours for this information collection:
Submission for OMB Review; Comment Request; Training Tomorrow's Scientists: Linking Minorities and Mentors Through the Web
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of Behavioral and Social Sciences Research (OBSSR), the National Institutes of Health (NIH) has submitted to the Office of management and Budget (OMB) a request for review and approval of the information collection listed below. This Proposed information collection was previously published in the Federal Register on January 11, 2005, page 1898 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: Training Tomorrow's Scientists: Linking Minorities and Mentors Through the Web. Type of Information Collection Request: Revision, OMB control number 0925-0475, Expiration Date 3/31/ 2005. Need and Use of Information Collection: This Web site allows federally-funded researchers supported by any of the 27 Institutes and Centers of the NIH to submit an electronic form describing his or her research areas, as well as interests in mentoring minority students or junior faculty. The researcher's description is posted on the Web site for searching by interested minority applicants. Minority students or junior faculty search the Web site to identify researchers with whom they would like to work. The research projects in the database are located all over the country and involve cutting edge research activities by scientists funded through the Institutes and Centers of the NIH. These research projects range from studies of children to research on older adults, from laboratory research to field research, from social research to a combination of biological and behavioral research. Applicants conduct an electronic search using categories such as research areas of interest, desired geographic location of the researcher, and their level of education. The primary objective of the program is to ensure that, in the coming decades, a concentration of minority researchers will be available to address behavioral and social factors important in improving the public health and eliminating racial disparities. Increasing the number of minority scientists in the U.S. will expand our currently limited knowledge about the epidemiology and treatment of diseases in minority population. Frequency of Response: On occasion. Affected Public: Individuals or households. Type of Respondents: Students, Post-doctorals, Junior Faculty, and Principal Investigators. The annual reporting burden is as follows: Estimated Number of Respondents: 400; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: 10 minutes; and Estimated Total Annual Burden Hours Requested: 148. There is no annualized cost to respondents. There are no Capital Costs, Operating Costs and/or Maintenance Costs to report.
Authorization of Emergency Use of Anthrax Vaccine Adsorbed for Prevention of Inhalation Anthrax by Individuals at Heightened Risk of Exposure Due to Attack With Anthrax; Extension; Availability
The Food and Drug Administration (FDA) is announcing an extension of the Emergency Use Authorization (EUA) (the Authorization) for Anthrax Vaccine Adsorbed (AVA), issued on January 27, 2005, for prevention of inhalation anthrax for individuals between 18 and 65 years of age who are deemed by the Department of Defense (DoD) to be at heightened risk of exposure due to attack with anthrax. The FDA Commissioner is extending the term of this Authorization on the request of DoD.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
