Department of Health and Human Services March 2014 – Federal Register Recent Federal Regulation Documents
Results 151 - 200 of 340
Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Procedures for the Safe Processing and Importing of Fish and Fishery Products
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Procedures for the Safe Processing and Importing of Fish and Fishery Products'' 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; Designation of New Animal Drugs for Minor Use or Minor Species-Final Rule
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Designation of New Animal Drugs for Minor Use or Minor Species (MUMS)Final Rule'' 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; Eye Tracking Experimental Studies To Explore Consumer Use of Food Labeling Information and Consumer Response to Online Surveys
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Eye Tracking Experimental Studies To Explore Consumer Use of Food Labeling Information and Consumer Response to Online Surveys'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
New Animal Drug Applications; Confidentiality of Data and Information in a New Animal Drug Application File
The Food and Drug Administration (FDA or Agency) is proposing to amend its regulation regarding the confidentiality of data and information in and about new animal drug application files to change when certain approval-related information would be disclosed by the Agency. This change would ensure that the Agency is able to update its list of approved new animal drug products within the statutory timeframe. It would also permit more timely public disclosure of approval-related information, increasing the transparency of FDA decision making in the approval of new animal drugs.
New Animal Drug Applications; Confidentiality of Data and Information in a New Animal Drug Application File
The Food and Drug Administration (FDA) is amending its regulation regarding the confidentiality of data and information in and about new animal drug application files to change when certain approval-related information will be disclosed by the Agency. This change will ensure that the Agency is able to update its list of approved new animal drug products within the statutory timeframe. It will also permit more timely public disclosure of approval-related information, increasing the transparency of FDA decision making in the approval of new animal drugs.
Draft Guidance for Industry on Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products.'' This guidance clarifies the FDA requirements and regulations pertaining to allowable excess volume in injectable vials and reinforces the importance of appropriate packaging sizes for injectable drug \1\ and biological products.
Submission for OMB Review; 30-Day Comment Request; Cardiovascular Health and Needs Assessment in Washington, DC-Development of a Community-Based Behavioral Weight Loss Intervention
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, 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 2, 2014, Volume 79, Issue Number 1, pages 41-42 and allowed 60-days for public comment. Public comments were received during the 60-day period. The purpose of this notice is to allow an additional 30 days for public comment. The National Heart, Lung and Blood Institute (NHLBI), 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. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.
Prospective Grant of an Exclusive Evaluation License Agreement: Pre-Clinical Evaluation and Commercial Development of Anti-Tyrosine Kinase-Like Orphan Receptor 1 Antibody-Drug Conjugates for the Treatment of Human Cancers
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, 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 61/ 172,099 entitled ``Anti-human ROR1 Antibodies'' [HHS Ref. E-097-2009/0- US-01], PCT Application No. PCT/US2010/032208 entitled ``Anti-human ROR1 Antibodies'' [HHS Ref. E-097-2009/0-PCT-02], U.S. Patent Application 61/418,550 entitled, ``Chimeric Rabbit/Human ROR1 Antibodies'' [HHS Ref. No. E-039-2011/0-US-01], and PCT Application No. PCT/US2011/062670 entitled, ``Chimeric Rabbit/Human ROR1 Antibodies'', and all related continuing and foreign patents/patent applications for the technology family, to Ardeagen Corporation. The patent rights in these inventions have been assigned to the Government of the United States of America. The prospective start-up exclusive evaluation option license territory may be worldwide and the field of use may be limited to pre- clinical evaluation and commercial development of an antibody-drug conjugate comprising an anti-tyrosine protein kinase transmembrane receptor (ROR1) antibody for the treatment of human ROR1 expressing cancers, wherein the antibody moiety comprises the anti-ROR1 antibodies designated as 2A2, 2D11, R11, R12, or R31. For avoidance of doubt, this Agreement explicitly excludes the development of an immunotoxin comprising 2A2 and Pseudomonas exotoxin A targeted immunotoxins for the treatment of human ROR1 expressing cancers. Upon expiration or termination of the start-up exclusive evaluation option license, Ardeagen Corporation will have the right to execute a start-up exclusive patent commercialization license which will supersede and replace the start-up exclusive evaluation option license with no broader territory than granted in the start-up exclusive evaluation option license and the field of use will be commensurate with the commercial development plan at the time of conversion.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for reinstatement of a previously-approved information collection assigned OMB control number 0955-0009, which expired on February 28, 2014. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Respiratory Protective Devices Used in Healthcare
Respiratory protective devices (RPDs) that are approved by the National Institute for Occupational Safety and Health (NIOSH) and also cleared by the Food and Drug Administration (FDA) \a\ as medical devices are widely used in surgical and non-surgical healthcare environments. There are reports \b\ that other NIOSH-approved RPDs that are not FDA-cleared medical devices are also being used to protect healthcare workers from inhalation hazards. The desirability of NIOSH incorporating additional requirements and tests in its 42 CFR Part 84 respirator approval process to parallel the protections in the FDA clearance process for Surgical N95 Respirators in surgical and non- surgical healthcare environments has been mentioned during broad-based and cross-agency discussions for future pandemic events as well as day- to-day use in healthcare settings.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Importer's Entry Notice
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.
Proposed Collection; 60-Day Comment Request; Evaluation of National Institutes of Health International Bilateral Programs (FIC, NCI, NIAAA, NIAID, NICHD, NIDA, NINDS, NIMH, OAR)
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 National Cancer Institute (NCI), 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. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Julie Schneider, Program Director, Center for Global Health, National Cancer Institute, 9609 Medical Center Dr., RM 3W564, Rockville, MD 20850 or call non-toll-free number 240-276-5795 or Email your request, including your address to: schneidj@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing.
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. 209 and 37 CFR part 404 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.
Food Additives Permitted in Feed and Drinking Water of Animals; Benzoic Acid
The Food and Drug Administration (FDA) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of benzoic acid as an acidifying agent in swine feed. This action is in response to a food additive petition filed by DSM Nutritional Products.
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency's Division of Dockets Management.
Issuance of Priority Review Voucher; Rare Pediatric Disease Product
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. FDA has determined that VIMIZIM (elosulfase alfa), manufactured by BioMarin Pharmaceutical, Inc., meets the criteria for a priority review voucher.
Scientific Information Request on Radiotherapy Treatments for Head and Neck Cancer
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public on 3- Dimensionsal Conformal Radiotherapy (3DRT), Intensity-Modulated Radiotherapy (IMRT), Stereotactic Body Radiotherapy (SBRT), and Proton Beam Radiotherapy (PBRT). Scientific information is being solicited to inform our update review of Radiotherapy Treatments for Head and Neck Cancer, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on 3- Dimensionsal Conformal Radiotherapy (3DRT), Intensity-Modulated Radiotherapy (IMRT), Stereotactic Body Radiotherapy (SBRT), and Proton Beam Radiotherapy (PBRT) will improve the quality of this review. AHRQ is conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173, and Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a).
Agency Information Collection Activities: Proposed Collection: Public Comment Request
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. 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.
Advisory Committee on Organ Transplantation Request for Nominations for Voting Members
The Health Resources and Services Administration (HRSA) is requesting nominations to fill vacancies on the Advisory Committee on Organ Transplantation (ACOT). The ACOT was established by the Amended Final Rule of the Organ Procurement and Transplantation Network (OPTN) (42 CFR Part 121) and, in accordance with Public Law 92-463, was chartered on September 1, 2000.
Solicitation for Nominations for Members of the U.S. Preventive Services Task Force (USPSTF)
The Agency for Healthcare Research and Quality (AHRQ) invites nominations of individuals qualified to serve as members of the U.S. Preventive Services Task Force (USPSTF).
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