Department of Health and Human Services February 2007 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 269
Determination of Regulatory Review Period for Purposes of Patent Extension; TYGACIL
The Food and Drug Administration (FDA) has determined the regulatory review period for TYGACIL and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Exception From General Requirements for Informed Consent
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; Proposed Collection; Comment Request; Label Comprehension Study
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 a questionnaire to evaluate reader's comprehension of three versions of condom labeling through a label comprehension study.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on How to Use E-Mail to Submit a Notice of Intent to Slaughter for Human Food Purposes
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; Establishing and Maintaining a List of United States Dairy Product Manufacturers/Processors With Interest in Exporting to Chile
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors with Interest in Exporting to Chile'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
National Institutes of Health Proposed Collection; Proposed Reinstatement of Collection With Changes; Comment Request; Second National Survey To Evaluate the National Institutes of Health (NIH) Small Business Innovation Research (SBIR) Program
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Office of the Director (OD), Office of Extramural Research (OER), Office of Extramural Programs (OEP), National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// workplace.samhsa.gov and https://www.drugfreeworkplace.gov.
Draft Guidance for Industry on Developing Products for Weight Management; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Developing Products for Weight Management.'' FDA is interested in updating the September 1996 draft guidance entitled ``Guidance for the Clinical Evaluation of Weight-Control Drugs'' by incorporating the latest scientific and clinical advances in the drug development field of obesity, including recommendations on the development of products for weight management in pediatric patients and in patients with medication-induced weight gain, and recommendations on the development of combinations of weight-management products. This action is expected to provide clear and consistent advice to those in industry who are interested in developing weight-management products.
Implantation or Injectable Dosage Form New Animal Drugs; Trenbolone Acetate and Estradiol
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Intervet, Inc. The NADA provides for use of an additional dose of trenbolone acetate and estradiol implant used for increased rate of weight gain and improved feed efficiency in feedlot steers.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on How to Use E-Mail to Submit a Request for a Meeting or Teleconference to the Office Of New Animal Drug Evaluation
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; Submission for Office of Management and Budget Review; Comment Request; Mammography Quality Standards Act Requirements
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; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on How To Use E-Mail To Submit a Study Protocol
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; Submission for Office of Management and Budget Review; Comment Request; General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Forms FDA 356h and 2567; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of February 2, 2007 (72 FR 5057). The document announced that an opportunity for public comment on a proposed collection of information had been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. The notice published with an error in titles referring to an FDA form number in two places in the document. This document corrects those errors.
Sentinel Network To Promote Medical Product Safety; Public Meeting
The Food and Drug Administration (FDA) is extending to February 28, 2007, registration for the public meeting that will be held on March 7 and 8, 2007, regarding FDA's exploration and development of an integrated national network to link private sector and public sector postmarket safety efforts, creating a virtual, integrated, electronic ``Sentinel Network''. Such a network would integrate existing and planned efforts to collect, analyze, and disseminate medical product safety information to health care practitioners and patients at the point-of-care. It would be established through multiple, broad-based, public-private partnerships. Dates and Times: The public meeting will be held on March 7 and 8, 2007, from 8 a.m. to 5 p.m. Location: The public meeting will be held at the University System of Maryland Shady Grove Center, 8630 Gudelsky Dr., Rockville, MD 20850.
Office of the National Coordinator for Health Information Technology; American Health Information Community Meeting
This notice announces the 12th meeting of the American Health Information Community in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.) The American Health Information Community will advise the Secretary and recommend specific actions to achieve a common interoperability framework for health information technology (IT).
Office of the National Coordinator for Health Information Technology, American Health Information Community Population Health and Clinical Care Connections Workgroup Meeting
This notice announces the 14th meeting of the American Health Information Community Population Care and Clinical Care Connections Workgroup [formerly Biosurveillance Workgroup] in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.)
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Alzheimer's Disease Demonstration Grants to States Program Standardized Data Collection
The Administration on Aging (AoA) is announcing that the proposed collection of information listed below 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; Submission for Office of Management and Budget Review; Comment Request; Substantial Evidence of Effectiveness of New Animal Drugs
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.
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.
Agency Information Collection Activities: Submission for Office of Management and Budget Review; Comment Request; Export of Medical Devices-Foreign Letters of Approval
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.
Prospective Grant of Exclusive License: Field of Use: Development of a Live Microbicide for Preventing Sexual Transmission of HIV
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: (1) U.S. Patent No. 5,821,081, filed April 26, 1996, issued Oct. 13, 1998, entitled ``Nucleic Acids Encoding Antiviral Proteins and Peptides, Vectors and Host Cells Comprising Same, and Methods of Producing the Antiviral Proteins and Peptides'' (E-117-1995/1-US-01) (Inventors: Michael R. Boyd, Kirk R. Gustafson, Robert H. Shoemaker, and James B. McMahon) (NCI); (2) U.S. Patent No. 5,843,882, filed April 27, 1995, issued Dec. 01, 1998, entitled ``Antiviral Proteins and Peptides, DNA, DNA-coding Sequences Therefore, and Uses thereof `` (E-117-1995/0-US-01) (Inventors: Michael R. Boyd, Kirk R. Gustafson, Robert H. Shoemaker, and James B. McMahon) (NCI); (3) U.S. Patent No. 5,998,587, filed Nov. 13, 1997, issued Dec. 7, 1999, entitled ``Anti-cyanovirin Antibody'' (E-117-1995/1-US-02) (Inventors: Michael R. Boyd, Kirk R. Gustafson, Robert H. Shoemaker, and James B. McMahon) (NCI); (4) U.S. Patent No. 6,015,876, filed Oct. 27, 1999, issued Jan. 18, 2000, entitled ``Method of Using Cyanovirins'' (E-117-1995/0-US-02) (Inventor: Michael R. Boyd, Kirk R. Gustafson, Robert H. Shoemaker, and James B. McMahon) (NCI); (5) U.S. Patent No. 6,780,847, filed March 22, 2001, issued August 24, 2004, entitled ``Glycosylation-Resistant Cyanovirins and Related Conjugates, Compositions, Nucleic Acids, Vectors, Host Cells, Methods of Production and Methods of Using Nonglycosylated Cyanovirins'' (E- 074-1999/3-US-01) (Inventors: Michael R. Boyd, Barry O'Keefe, Toshiyuki Mori (NCI) and Angela Gronenborn (NIDDK)); (6) U.S. Patent No. 7,048,935, filed July 1, 2002, issued May 23, 2006, entitled ``Cyanovirin Conjugates and Matrix-Anchored Cyanovirin and Related Compositions and Methods of Use'' (E-074-1999/1-US-03) (Inventor: Michael R. Boyd (NCI); (7) U.S. Patent No. 7,105,169, filed September 12, 2001, issued September 12, 2006, entitled ``Cyanovirins Conjugates and Matrix- Anchored Cyanovirins and Methods of Use'' (E-074-1999/1-US-02) (Inventor: Michael R. Boyd (NCI); (8) U.S. Patent No. 6,743,577, filed October 27, 1999, issued June 1, 2004, entitled `` Methods of Using Cyanovirins to Inhibit Viral Infection'' (E-074-1999/0-US-03) (Inventor: Michael R. Boyd (NCI);
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; How to Use E-mail to Submit a Notice of Final Disposition of Animals Not Intended for Immediate Slaughter
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; Food Labeling; Notification Procedures for Statements on Dietary Supplements
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Food Labeling; Notification Procedures for Statements on Dietary Supplements'' 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; Comment Request; Guidance for Industry on How to Use E-mail to Submit Information to the Center for Veterinary Medicine
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; User Fee Cover Sheet; Form FDA 3397
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``User Fee Cover Sheet; Form FDA 3397'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Procedures for the Clinical Laboratory Improvement Amendments of 1998 Categorization
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 for an existing collection of information and to allow 60 days for public commein response to the notice. This notice solicits comments on administrative procedures for the Clinical Laboratory Improvement Amendments of 1988 (CLIA) categorization.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Agreement for Shipment of Devices for Sterilization
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.
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