Department of Health and Human Services April 26, 2013 – Federal Register Recent Federal Regulation Documents
Results 1 - 22 of 22
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Health Resources and Services Administration (HRSA) will submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. To request a copy of the clearance requests submitted to OMB for review, email paperwork@hrsa.gov or call the HRSA Reports Clearance Office at (301) 443-1984.
Health Center Program
The Health Resources and Services Administration (HRSA) will be transferring Health Center Program (section 330 of the Public Health Service Act) funds originally awarded to the County of Genesee to ensure the provision of critical primary health care services to underserved populations in Genesee County, Michigan.
National Toxicology Program Board of Scientific Counselors; Announcement of Meeting; Request for Comments
This notice announces the next meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC). The NTP BSC, a federally chartered, external advisory group composed of scientists from the public and private sectors, will review and provide advice on programmatic activities. The meeting is open to the public and preregistration is requested for both public attendance and comment. Information about the meeting and registration is available at https://ntp.niehs.nih.gov/go/165.
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.
National Institutes of Health
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 a start-up exclusive patent license to practice the inventions embodied in U.S. Provisional Patent Application No. 60/026,816, entitled ``O\2\-Aryl Substituted Diazeniumdiolates'', filed September 27, 1996, now abandoned (HHS Ref. No. E-093-1996/0-US-01); U.S. Provisional Patent Application No. 60/045,917, entitled ``O\2\-Aryl Substituted Diazeniumdiolates and Use Thereof'', filed May 7, 1997, now abandoned (HHS Ref. No. E-093-1996/1-US-01); U.S. Provisional Patent Application No. 60/051,696, entitled ``O\2\-Glycosylated 1-Substituted Diazen-l- IUM-1,2-Diolates and O\2\-Substituted 1-[(2-Carboxylato) Pyrrolidin-1- YL] Diazen-1-IUM-l,2-Diolates'', filed July 3, 1997, now abandoned (HHS Ref. No. E-093-1996/2-US-01); PCT Patent Application No. PCT/US1997/ 017267, entitled ``O\2\-Arylated or O\2\-Glycosylated 1-Substituted Diazen-l-IUM-1,2-Diolates and O\2\-Substituted 1-[(2-Carboxylato) Pyrrolidin-1-YL] Diazen-1-IUM-l,2-Diolates'', filed September 26, 1997, now abandoned (HHS Ref. No. E-093-1996/3-PCT-01); European Patent No. 0929538, entitled ``O\2\-Arylated or O\2\-Glycosylated 1-Substituted Diazen-l-IUM-1,2-Diolates and O\2\-Substituted 1-[(2-Carboxylato) Pyrrolidin-1-YL] Diazen-1-IUM-l,2-Diolates'', issued on November 24, 2004 [HHS Ref. No. E-093-1996/3-EP-02], which is validated in Great Britain [E-093-1996/3-GB-09], Germany [E-093-1996/3-DE-10], France [E- 093-1996/3-FR-11], Ireland [E-093-1996/3-IE-12], Italy [E-093-1996/3- IT-13], Switzerland [E-093-1996/3-CH-14] and Belgium [E-093-1996/3-BE- 15]; Australian Patent No. 733590, entitled ``O\2\-Arylated or O\2\- Glycosylated 1-Substituted Diazen-l-IUM-1,2-Diolates and O\2\- Substituted 1-[(2-Carboxylato) Pyrrolidin-1-YL] Diazen-1-IUM-l,2- Diolates'', issued on August 30, 2001 [HHS Ref. No. E-093-1996/3-AU- 03]; Canadian Patent No. 2266908, ``O\2\-Arylated or O\2\-Glycosylated 1-Substituted Diazen-l-IUM-1,2-Diolates and O\2\-Substituted 1-[(2- Carboxylato) Pyrrolidin-1-YL] Diazen-1-IUM-l,2-Diolates,'' issued on July 20, 2010 [HHS Ref. No. E-093-1996/3-CA-04]; Japanese Patent No. 4285775, ``O\2\-Arylated or O\2\-Glycosylated 1-Substituted Diazen-l- IUM-1,2-Diolates and O\2\-Substituted 1-[(2-Carboxylato) Pyrrolidin-1- YL] Diazen-1-IUM-l,2-Diolates,'' issued on April 3, 1999 [HHS Ref. No. E-093-1996/3-JP-05]; U.S. Patent No. 6,610,660, entitled ``O\2\- Arylated or O\2\-Glycosylated 1-Substituted Diazen-l-IUM-1,2-Diolates and O\2\-Substituted 1-[(2-Carboxylato) Pyrrolidin-1-YL] Diazen-1-IUM- l,2-Diolates,'' issued on August 26, 2003 [HHS Ref. No. E-093-1996/3- US-06]; U.S. Patent No. 6,911,433, entitled ``O\2\-Glycosylated 1- Substituted Diazen-l-IUM-1,2-Diolates,'' issued on June 28, 2005 [HHS Ref. No. E-093-1996/3-US-07]; European Patent Application No. 04009529.1, entitled ``O\2\-Arylated or O\2\-Glycosylated 1-Substituted Diazen-l-IUM-1,2-Diolates and O\2\-Substituted 1-[(2-Carboxylato) Pyrrolidin-1-YL] Diazen-1-IUM-l,2-Diolates,'' filed on April 22, 2004 [E-093-1996/3-EP-08]; U.S. Patent No. 7,081,524, entitled ``O\2\- Substituted 1-[(2-Carboxylato)Pyrrolidin-1-YL] Diazen-1-IUM-l,2- Diolates,'' issued on July 25, 2006 [HHS Ref. No. E-093-1996/3-US-16]; Japanese Patent No. 5015903, entitled ``O\2\-Substituted 1-[(2- Carboxylato)Pyrrolidin-1-YL] Diazen-1-IUM-l,2-Diolates and Compositions Thereof,'' issued on June 15, 2012 [HHS Ref. No. E-093-1996/3-JP-17]; Canadian Patent Application No. 2,705,474, entitled ``O\2\-Glycosylated 1-Substituted Diazen-1-IUM-l,2-Diolates,'' filed on May 28, 2010 [E- 093-1996/3-CA-18]; and European Patent Application No. 10010885.1, entitled ``O\2\-Substituted 1-[(2-Carboxylato)Pyrrolidin-1-YL] Diazen- 1-IUM-l,2-Diolates,'' filed on September 24, 2012 [E-093-1996/3-EP-19], developed by Dr. Larry K. Keefer, Dr. Joseph E. Saavedra, et al. The prospective exclusive license territory may be ``worldwide'', and the field of use may be limited to: ``use of O\2\-Arylated, O\2\- Glycosylated 1-Substituted Diazen-l-IUM-1,2-Diolates, and O\2\- Substituted 1-[(2-Carboxylato) Pyrrolidin-1-YL] Diazen-1-IUM-l,2- Diolates for cancer treatment and prevention in humans.'' to JSK Therapeutics, Inc. (``JSKT''), a company incorporated under the laws of the State of Delaware having an office in at least Salt Lake City, Utah, U.S.A. The patent rights in these inventions have been assigned to the United States of America.
Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Regulatory Classification of Pharmaceutical Co-Crystals.'' This guidance provides applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) with the Center for Drug Evaluation and Research's (CDER's) current thinking on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms. This guidance also provides information about the data the applicant should submit to support the appropriate classification of a co-crystal, as well as the regulatory implications of the classification. The recommendations in this guidance apply to materials that the Agency has not previously evaluated and determined to be pharmaceutical co-crystals. The recommendations do not apply to materials that the Agency has previously designated as salts, complexes, or other non-co- crystalline forms.
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Extension of Comment Periods
The Food and Drug Administration (FDA or we) is extending the comment period for the proposed rule, and for the information collection related to the proposed rule, ``Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food'' that appeared in the Federal Register of January 16, 2013. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments on the proposed rule. We also are taking this action to keep the comment period for the information collection provisions associated with the rule consistent with the comment period for the proposed rule.
Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm; Availability; Extension of the Comment Period
The Food and Drug Administration (FDA or we) is extending the comment period for a document that we made available for public comment by notification in the Federal Register of January 16, 2013. We are taking this action to make the comment period for the draft RA conform to the comment period for proposed rules entitled ``Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food'' (the proposed preventive controls rule) and ``Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption'' (the proposed produce safety rule). Elsewhere in this issue of the Federal Register, we are announcing a 120-day extension of the comment period for the proposed preventive controls rule and the proposed produce safety rule.
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Comment Periods
The Food and Drug Administration (FDA or we) is extending the comment period for the proposed rule, and for the information collection related to the proposed rule, ``Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption'' that appeared in the Federal Register of January 16, 2013. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments on the proposed rule. We also are taking this action to keep the comment period for the information collection provisions associated with the rule consistent with the comment period for the proposed rule.
Scientific Information Request Therapies for Clinically Localized Prostate Cancer
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from medical device manufacturers with products falling within the following UMDNS product codes: Brachytherapy Systems [20-352]; Cyclotrons [15-818]; Radiotherapy Systems, Linear Accelerator [12-364]; Radiotherapy Systems, and Proton Beam [20-546]. Scientific information is being solicited to inform the update of our Comparative Effectiveness Review of Therapies for Clinically Localized Prostate Cancer which is currently being conducted by one of the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on this device will improve the quality of this comparative effectiveness review. AHRQ is requesting this scientific information and conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173.
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