Energy Policy and New Uses Office, Agriculture Department – Federal Register Recent Federal Regulation Documents

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Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2015-20813
Type: Notice
Date: 2015-08-24
Agency: Energy Policy and New Uses Office, Agriculture Department, Defense Nuclear Facilities Safety Board
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection entitled School-Associated Violent Deaths Surveillance System (SAVDSS). CDC will use the information to continue the ongoing surveillance of school-associated violent deaths (SAVD), to track and monitor the extent of school-associated violence.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2015-20812
Type: Notice
Date: 2015-08-24
Agency: Energy Policy and New Uses Office, Agriculture Department, Defense Nuclear Facilities Safety Board
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection entitled ``Screening and Counseling of Male EVD Survivors to Reduce Risk of Sexually Transmitting Ebola Virus in Guinea''. This activity will collect information on participants' laboratory results and sexual activity prior to and during participation in the screening program.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2015-20811
Type: Notice
Date: 2015-08-24
Agency: Energy Policy and New Uses Office, Agriculture Department, Defense Nuclear Facilities Safety Board
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2015-20787
Type: Notice
Date: 2015-08-24
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol and Tobacco Tax and Trade Bureau
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.
Notice To Propose the Redesignation of the Service Delivery Area for the Wampanoag Tribe of Gay Head (Aquinnah)
Document Number: 2015-20781
Type: Notice
Date: 2015-08-24
Agency: Energy Policy and New Uses Office, Agriculture Department, National Drug Control Policy Office
This notice advises the public that the Indian Health Service (IHS) proposes to expand the geographic boundaries of the Service Delivery Area for the Wampanoag Tribe of Gay Head (Aquinnah) of Massachusetts. The Aquinnah service delivery area is currently comprised of members of the Tribe residing in Martha's Vineyard, Dukes County in the State of Massachusetts. The Bureau of Indian Affairs (BIA) recognized the Wampanoag Tribe of Gay Head on February 10, 1987. Martha's Vineyard, Dukes County was designated as the Aquinnah service delivery area in the Wampanoag Tribal Council of Gay Head, Inc., Indian Claims Settlement Act of 1987, Public Law 100-95.
Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar Applicant
Document Number: 2015-20780
Type: Notice
Date: 2015-08-24
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is publishing notice that an applicant for a proposed biosimilar product notified FDA that a patent infringement action was filed in connection with the applicant's biologics license application (BLA). Under the Public Health Service Act (PHS Act), an applicant for a proposed biosimilar product or interchangeable product must notify FDA within 30 days after the applicant was served with a complaint in a patent infringement action described under the PHS Act. FDA is required to publish notice of the complaint in the Federal Register.
Agency Information Collection Activities; Proposed Collection; Comment Request; Dietary Supplement Labeling Requirements and Recommendations Under the Dietary Supplement and Nonprescription Drug Consumer Protection Act
Document Number: 2015-20760
Type: Notice
Date: 2015-08-24
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA or we) 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. This notice solicits comments on the information collection provisions of the Dietary Supplement and Nonprescription Drug Consumer Protection Act (the DSNDCPA) and the guidance document entitled, ``Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.''
Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products; Request for Comments; Extension of Comment Period
Document Number: 2015-20759
Type: Proposed Rule
Date: 2015-08-24
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is extending the comment period for the advance notice of proposed rulemaking (ANPRM) entitled ``Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products'' that appeared in the Federal Register of July 1, 2015. In the ANPRM, FDA requested comments, data, research results, or other information, that may inform regulatory actions that FDA might take with respect to nicotine exposure warnings and child-resistant packaging for liquid nicotine and nicotine-containing e-liquid(s) that are made or derived from tobacco and intended for human consumption, and potentially for other tobacco products including, but not limited to, novel tobacco products such as dissolvables, lotions, gels, and drinks. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 2015-20753
Type: Notice
Date: 2015-08-24
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2015-20752
Type: Notice
Date: 2015-08-24
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
Submission for OMB Review; Comment Request
Document Number: 2015-20716
Type: Notice
Date: 2015-08-21
Agency: Energy Policy and New Uses Office, Agriculture Department, Executive Office of the President
Submission for OMB Review; 30-Day Comment Request; Web-Based Resource for Youth About Clinical Research
Document Number: 2015-20708
Type: Notice
Date: 2015-08-21
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
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 3/12/2015 pages 13013-13014, and allowed 60-days for public comment. One public comment was received. 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.
Proposed Information Collection Activity; Comment Request
Document Number: 2015-20703
Type: Notice
Date: 2015-08-21
Agency: Energy Policy and New Uses Office, Agriculture Department, Executive Office of the President
Government-Owned Inventions; Availability for Licensing
Document Number: 2015-20694
Type: Notice
Date: 2015-08-21
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
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.
Listing of Color Additives Exempt From Certification; Spirulina Extract
Document Number: 2015-20676
Type: Rule
Date: 2015-08-21
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of spirulina extract as a color additive in coating formulations applied to dietary supplement and drug tablets and capsules. This action is in response to a petition filed by Colorcon, Inc. (Colorcon).
Notice of Charter Renewal
Document Number: 2015-20646
Type: Notice
Date: 2015-08-21
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2015-20645
Type: Notice
Date: 2015-08-21
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
National Cancer Institute; Notice of Closed Meeting
Document Number: 2015-20644
Type: Notice
Date: 2015-08-21
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
National Institute on Aging; Notice of Closed Meeting
Document Number: 2015-20643
Type: Notice
Date: 2015-08-21
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
National Cancer Institute; Notice of Closed Meetings
Document Number: 2015-20642
Type: Notice
Date: 2015-08-21
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
Notice of the Intent to Award a Single-Source Grant to the National Association of States United for Aging and Disabilities
Document Number: 2015-20392
Type: Notice
Date: 2015-08-21
Agency: Energy Policy and New Uses Office, Agriculture Department, Denali Commission
The Administration for Community Living (ACL) announces the intent to award a single-source grant award in the amount of $285,000 to the National Association of State United for Aging and Disabilities (NASUAD). This award is to support and stimulate the expansion of work already under way by NASUAD to further develop and assist states to implement a valid and reliable National Core Indicator Survey for older adults and people with physical disabilities (NCI-AD). Program Name: National Core Indicator Survey. Award Amount: $285,000.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2015-20599
Type: Notice
Date: 2015-08-20
Agency: Energy Policy and New Uses Office, Agriculture Department, Federal Reserve System
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Online Application Order Form for Products from the Healthcare Cost and Utilization Project (HCUP).'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501- 3521, AHRQ invites the public to comment on this proposed information collection.
Patient Safety Organizations: Voluntary Relinquishment From Schumacher Group Patient Safety Organization, Inc.
Document Number: 2015-20598
Type: Notice
Date: 2015-08-20
Agency: Energy Policy and New Uses Office, Agriculture Department, Federal Reserve System
The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to b-26, (Patient Safety Act) and the related Patient Safety and Quality Improvement Final Rule, 42 CFR part 3 (Patient Safety Rule), published in the Federal Register on November 21, 2008, (73 FR 70732-70814), provide for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety Rule authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ has accepted a notification of voluntary relinquishment from Schumacher Group Patient Safety Organization, Inc. of its status as a PSO, and has delisted the PSO accordingly.
Patient Safety Organizations: Voluntary Relinquishment From Close Care Gap, PSO
Document Number: 2015-20597
Type: Notice
Date: 2015-08-20
Agency: Energy Policy and New Uses Office, Agriculture Department, Federal Reserve System
The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to b-26, (Patient Safety Act) and the related Patient Safety and Quality Improvement Final Rule, 42 CFR part 3 (Patient Safety Rule), published in the Federal Register on November 21, 2008, (73 FR 70732-70814), provide for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety Rule authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ has accepted a notification of voluntary relinquishment from Close Care Gap, PSO of its status as a PSO, and has delisted the PSO accordingly.
Submission for OMB Review; 30-Day Comment Request; Identifying Experts in Prevention Science Methods To Include on NIH Review Panels (OD)
Document Number: 2015-20591
Type: Notice
Date: 2015-08-20
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), Office of Disease Prevention (ODP) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on April 7, 2015, page 18641 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. 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, Attn: NIH Desk Officer.
Agency Information Collection Activities; Proposed Collection; Comment Request; Comment Request; Interstate Shellfish Dealers Certificate
Document Number: 2015-20562
Type: Notice
Date: 2015-08-20
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on our 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 the information collection provisions of the Interstate Shellfish Dealers Certificate.
Lisa Marie Coroniti: Debarment Order
Document Number: 2015-20561
Type: Notice
Date: 2015-08-20
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The U.S. Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Lisa Coroniti from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Ms. Coroniti was convicted of a felony under Federal law for conduct relating to the regulation of a drug product. Ms. Coroniti was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Ms. Coroniti failed to request a hearing. Ms. Coroniti's failure to request a hearing constitutes a waiver of her right to a hearing concerning this action.
Collecting On-Farm Antimicrobial Use and Resistance Data; Public Meeting; Request for Comments
Document Number: 2015-20557
Type: Notice
Date: 2015-08-20
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
Technical Document for Using the Inactive Ingredient Database; Establishment of a Public Docket
Document Number: 2015-20556
Type: Notice
Date: 2015-08-20
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA, or the Agency) is announcing the establishment of a public docket to receive comments from interested parties on enhancing the utility and usability of the Inactive Ingredient Database (IID) (also known as the Inactive Ingredient Guide). These comments will help FDA identify best practices to assist Agency staff in designing the IID and maintaining the information contained therein. We intend to identify and further develop these best practices in a technical guide or draft guidance to be issued at a later date.
Designating Additions to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act
Document Number: 2015-20554
Type: Rule
Date: 2015-08-20
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Federal Food, Drug, and Cosmetic Act (the FD&C Act) authorizes the Food and Drug Administration (FDA or Agency) to award priority review vouchers (PRVs) to tropical disease product applicants when the applications meet certain criteria. The FD&C Act lists the diseases that are considered to be tropical diseases for purposes of obtaining PRVs, and also provides for Agency expansion of that list to include other diseases that satisfy the definition of ``tropical diseases'' as set forth in the FD&C Act. FDA has determined that Chagas disease and neurocysticercosis satisfy this definition, and therefore is adding them to the list of designated tropical diseases whose product applications may result in the award of PRVs. Sponsors submitting certain applications for the treatment of Chagas disease and neurocysticercosis may be eligible to receive a PRV if such applications are approved by FDA.
Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS)
Document Number: 2015-20553
Type: Notice
Date: 2015-08-20
Agency: Energy Policy and New Uses Office, Agriculture Department, Defense Nuclear Facilities Safety Board
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2015-20552
Type: Notice
Date: 2015-08-20
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Modernization Commission
Pediatric Advisory Committee; Notice of Meeting; Correction
Document Number: 2015-20541
Type: Notice
Date: 2015-08-20
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of August 12, 2015 (80 FR 48325). Phenylephrine Hydrochloride was incorrectly linked to DUREZOL (difluprednate ophthalmic emulsion) 0.05% because they were both listed as item number 1 in the numbered list of products to be discussed at the meeting. Phenylephrine Hydrochloride Ophthalmic Solution is a separate stand-alone drug that will be reviewed by the committee and should be listed as item number 2. The other drugs in the numbered list should be renumbered accordingly. This document corrects that error.
Bone, Reproductive, and Urologic Drugs Advisory Committee; Notice of Meeting
Document Number: 2015-20540
Type: Notice
Date: 2015-08-20
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 2015-20518
Type: Notice
Date: 2015-08-20
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2015-20517
Type: Notice
Date: 2015-08-20
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2015-20516
Type: Notice
Date: 2015-08-20
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2015-20479
Type: Notice
Date: 2015-08-19
Agency: Energy Policy and New Uses Office, Agriculture Department, Defense Nuclear Facilities Safety Board
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed information collection request entitled ``Breast Cancer in Young Women Survey'', which is designed to assess insurance coverage, employment status and out-of-pocket health care expenses among young women diagnosed with breast cancer and to look at the relationship between these variables and treatment decisions.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2015-20478
Type: Notice
Date: 2015-08-19
Agency: Energy Policy and New Uses Office, Agriculture Department, Defense Nuclear Facilities Safety Board
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2015-20477
Type: Notice
Date: 2015-08-19
Agency: Energy Policy and New Uses Office, Agriculture Department, Defense Nuclear Facilities Safety Board
Proposed Collection; 60-Day Comment Request; National Toxicology Program (NTP) Level of Concern Categories Study (NIEHS)
Document Number: 2015-20474
Type: Notice
Date: 2015-08-19
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
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 Institute of Environmental Health Sciences (NIEHS), 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: Dr. Kristina Thayer, Director of the Office of Health Assessment and Translation, Division of National Toxicology Program, NIEHS, P.O. Box 12233, Mail Drop K2-04, Research Triangle Park, NC 27709, or call non- toll-free number (919) 541-5021, or Email your request, including your address to: thayer@niehs.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: National Toxicology Program Level of Concern Categories, 0925-NEW, National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). Need and Use of Information Collection: The National Toxicology Program (NTP) has used a 5-point level of concern (LoC) framework to communicate NTP's assessment of the degree of concern regarding the potential human health effects of selected substances given what is known about their toxicity, level of human exposure, and pharmacokinetics. As part of its systematic review methodologies, the NTP is updating its LoC framework to enhance transparency in what the LoC categories mean, describing the factors considered in reaching conclusions and identifying strategies for improving their use as a risk communication tool. This study will use expert solicitation from five NTP stakeholder sectors (academia, industry, non-government organizations, and federal and state agencies) to aid in determining the optimal number of LoC categories for an updated LoC framework. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 300.
Submission for OMB Review; 30-Day Comment Request; Information Program on Clinical Trials: Maintaining a Registry and Results Databank (NLM)
Document Number: 2015-20473
Type: Notice
Date: 2015-08-19
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
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 June 10, 2015, page 32968 and allowed 60-days for public comment. One public comment was received. The purpose of this notice is to allow an additional 30 days for public comment. The National Library of Medicine (NLM), 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. For Further Information Contact: To obtain a copy of the data collection plans and instruments or request more information on the proposed project contact: David Sharlip, Office of Administrative and Management Analysis Services, National Library of Medicine, Building 38A, Room B2N12, 8600 Rockville Pike, Bethesda, MD 20894, or call non- toll-free number (301) 402-9680, or Email your request, including your address to: sharlipd@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: Information Program on Clinical Trials: Maintaining a Registry and Results Databank (NLM), 0925-0586, Expiration Date 08/31/2015, EXTENSION, National Library of Medicine (NLM), National Institutes of Health (NIH). Need and Use of Information Collection: The National Institutes of Health operates ClinicalTrials.gov, which was established as a clinical trial registry under section 113 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) and was expanded to include a results data bank by Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA). ClinicalTrials.gov collects registration and results information for clinical trials and other types of clinical studies (e.g., observational studies and patient registries) with the objectives of enhancing patient enrollment and providing a mechanism for tracking subsequent progress of clinical studies, to the benefit of public health. It is widely used by patients, physicians, and medical researchers; in particular those involved in clinical research. While many clinical studies are registered and submit results information voluntarily, FDAAA requires the registration of certain applicable clinical trials of drugs and devices and the submission of results information for completed applicable clinical trials of drugs and devices that are approved, licensed, or cleared by the Food and Drug Administration. Beginning in 2009, results information was required to include information about serious and frequent adverse events. This extension request does not include any changes to the information submission requirements for ClinicalTrials.gov that were proposed in the Notice of Proposed Rulemaking on Clinical Trial Registration and Results Submission that was issued on November 21, 2014 and for which the public comment period closed on March 23, 2015 (79 FR 225, Nov. 21, 2014). The NIH is continuing to review submitted public comments as it prepares the final rule. The NIH will make any corresponding changes to the ClinicalTrials.gov information collection via separate procedure. OMB approval is requested for 3 years. There are no costs to respondents other than there their time. The total estimated annualized burden hours are 682,535.
National Institute on Aging: Notice of Closed Meeting
Document Number: 2015-20453
Type: Notice
Date: 2015-08-19
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
National Institute on Aging; Notice of Closed Meeting
Document Number: 2015-20452
Type: Notice
Date: 2015-08-19
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2015-20451
Type: Notice
Date: 2015-08-19
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
National Center for Advancing Translational Sciences: Notice of Meetings
Document Number: 2015-20450
Type: Notice
Date: 2015-08-19
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2015-20449
Type: Notice
Date: 2015-08-19
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
Office of the Director, National Institutes of Health: Notice of Meeting
Document Number: 2015-20448
Type: Notice
Date: 2015-08-19
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
Center for Devices and Radiological Health Participation in International Medical Device Regulators Forum, Regulated Product Submission, Table of Contents Pilot Program
Document Number: 2015-20430
Type: Notice
Date: 2015-08-19
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH), Offices of Device Evaluation (ODE) and In Vitro Diagnostics and Radiation (OIR) are announcing their participation in the International Medical Device Regulators Forum's (IMDRF) Regulated Product Submission Table of Contents Pilot Program. Participation in the Pilot is voluntary and open to applicants who submit premarket approval (PMA) applications or premarket notification (510(k)) to either ODE or OIR. The Pilot project is intended to provide industry, IMDRF, and CDRH staff the opportunity to evaluate the Table of Contents structure and to receive input from industry participants. Participants will be asked to submit their submissions electronically using IMDRF's Table of Contents (ToC) format.