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

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Announcement of Requirements and Registration for Million Hearts® Hypertension Control Challenge
Document Number: 2015-20076
Type: Notice
Date: 2015-08-14
Agency: Energy Policy and New Uses Office, Agriculture Department, Defense Nuclear Facilities Safety Board
The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) announces the launch of the Million Hearts[supreg] Hypertension Control Challenge on August 18, 2015. The challenge will be open until October 31, 2015. Million Hearts[supreg] is a national initiative to prevent one million heart attacks and strokes by 2017. Achieving this goal means 10 million more Americans must have their blood pressure under control. Million Hearts[supreg] is working to control high blood pressure through clinical approaches, such as using health information technology to its fullest potential and integrating team-based approaches to health care, and community approaches, such as strengthening tobacco control and lowering sodium consumption. For more information about the initiative, visit www.millionhearts.hhs.gov. To support improved blood pressure control, HHS/CDC is announcing the 2015 Million Hearts[supreg] Hypertension Control Challenge. The challenge will improve understanding of successful implementation strategies at the health system level by motivating clinical practices and health systems to strengthen their hypertension control efforts. It will identify clinicians, clinical practices, and health systems that have exceptional rates of hypertension control and recognize them as Million Hearts[supreg] Hypertension Control Champions. To support improved quality of care delivered to patients with hypertension, Million Hearts[supreg] will document the systems, processes, and staffing that contribute to the exceptional blood pressure control rates achieved by Champions. Champions will receive local and national recognition.
Proposed Information Collection Activity; Comment Request
Document Number: 2015-20073
Type: Notice
Date: 2015-08-14
Agency: Energy Policy and New Uses Office, Agriculture Department, Executive Office of the President
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2015-20063
Type: Notice
Date: 2015-08-14
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
Meeting of the National Advisory Committee on Children and Disasters
Document Number: 2015-20056
Type: Notice
Date: 2015-08-14
Agency: Energy Policy and New Uses Office, Agriculture Department
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Advisory Committee on Children and Disasters (NACCD) will be holding a meeting via teleconference. The meeting is open to the public.
Science Advisory Board to the National Center for Toxicological Research Advisory Committee; Notice of Meeting
Document Number: 2015-20051
Type: Notice
Date: 2015-08-14
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
National Mammography Quality Assurance Advisory Committee, Renewal
Document Number: 2015-20050
Type: Notice
Date: 2015-08-14
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is announcing the renewal of the National Mammography Quality Assurance Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the National Mammography Quality Assurance Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until July 6, 2017.
Intent To Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices From Premarket Notification Requirements; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2015-20005
Type: Notice
Date: 2015-08-14
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements,'' which updates an earlier guidance of the same title published in the Federal Register on July 1, 2015. This guidance describes FDA's intent to exempt certain unclassified medical devices (that FDA intends to classify into class I or II), certain class II medical devices, and certain class I medical devices from premarket notification requirements. Due to an administrative error, certain comments to this Docket were not considered prior to the July 1, 2015, guidance publication. These comments have now been considered. FDA believes additional devices and product codes are sufficiently well understood and do not require premarket notification to assure their safety and effectiveness. As such, FDA is updating and adding these to the guidance.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2015-19992
Type: Notice
Date: 2015-08-14
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 National Unintentional Drug Overdose Reporting System (NUDORS). CDC will use the information collected to perform fatal unintentional drug overdose surveillance in a quickly and comprehensive way.
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 040
Document Number: 2015-19991
Type: Notice
Date: 2015-08-14
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 040'' (Recognition List Number: 040), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Neurodiagnostics and Non-Invasive Brain Stimulation Medical Devices; Public Workshop; Request for Comments
Document Number: 2015-19990
Type: Notice
Date: 2015-08-14
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is announcing the following two-day public workshop entitled, ``Neurodiagnostics and Non- Invasive Brain Stimulation Medical Devices Workshop''. The focus of the first day of the workshop will be cognitive assessment medical devices, which are intended to provide healthcare professionals with an evaluation of cognitive function through non-invasive measurements. The focus of the second day of the workshop will be non-invasive brain stimulation medical devices, which are medical devices that are intended to improve, affect, or otherwise modify the cognitive function of a normal individual (i.e., without a treatment objective) by means of non-invasive electrical or electromagnetic stimulation to the head. The purpose of this workshop is to obtain public input and feedback on scientific, clinical, and regulatory considerations associated with medical devices for assessing and influencing cognitive function. Ideas generated during this workshop may facilitate further development of guidance regarding the content of premarket submissions for neurodiagnostics and non-invasive brain stimulation medical devices and help to speed development and approval of future submissions. Dates and Times: The public workshop will be held on November 19 and 20, 2015, from 8:30 a.m. to 5 p.m. Location: The public workshop will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to: http://www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation / ucm241740.htm. Contact Persons: Hilda Scharen, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm 3625, Silver Spring, MD 20993, 301-796-6815, Hilda.Scharen@fda.hhs.gov; or Jay Gupta, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, Jay.Gupta@fda.hhs.gov, 301-796-2795. Registration: Registration is free and available on a first-come, first-served basis. Persons interested in attending this public workshop must register online by November 6, 2015, at 4 p.m. Early registration is recommended because facilities are limited and, therefore, FDA may limit the number of participants from each organization. If time and space permits, onsite registration on the day of the public workshop will be provided beginning at 7:30 a.m. If you need special accommodations due to a disability, please contact Susan Monahan, susan.monahan@fda.hhs.gov or 301-796-5661 no later than November 5, 2015. To register for the public workshop, please visit FDA's Medical Devices Workshops and Conferences calendar at http://www.fda.gov/ MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. Select this meeting/public workshop from the posted events list. Please provide complete contact information for each attendee, including name, title, affiliation, email, and telephone number. Those without Internet access should contact Susan Monahan to register (see Contact for special accommodations). Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list. Streaming Webcast of the Public Workshop: This public workshop will also be available via Webcast. Persons interested in viewing the Webcast must register online by 4 p.m., November 6, 2015. Early registration is recommended because Webcast connections are limited. Organizations are requested to register all participants, but to view using one connection per location. Webcast participants will be sent technical system requirements after registration and will be sent connection access information after November 10, 2015. If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_ test.htm. To get a quick overview of the Connect Pro program, visit http:// www.adobe.com/go/connectpro_overview. (FDA has verified the Web site addresses in this document, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) Comments: In order to permit the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the public workshop topics. The deadline for submitting comments related to this public workshop is December 5, 2015. Regardless of attendance at the public workshop, interested persons may submit either electronic comments regarding this document to http:/ /www.regulations.gov or written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. In addition, when providing comments to the topics as outlined in section II of this document, please identify the question you are addressing. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http:// www.regulations.gov. Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov. It may be viewed at the Division of Dockets Management (see Comments). A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. The address of the Division of Freedom of Information is available on the Agency's Web site at http://www.fda.gov. A link to the transcripts will also be available approximately 45 days after the public workshop on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/ WorkshopsConferences/default.htm. (Select this public workshop from the posted events list).
Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses; Draft Guidance for Industry and Food and Drug Administration Staff: Availability
Document Number: 2015-19983
Type: Notice
Date: 2015-08-14
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses.'' This draft guidance provides recommendations to facilitate study designs to establish the performance characteristics of in vitro diagnostic devices (IVDs) intended for the detection, or detection and differentiation, of human papillomaviruses (HPVs). This draft guidance is not final nor is it in effect at this time.
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2015-19977
Type: Notice
Date: 2015-08-14
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
Eunice Kennedy Shriver National Institute of Child Health And Human Development; Notice of Closed Meeting
Document Number: 2015-19976
Type: Notice
Date: 2015-08-14
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
Eunice Kennedy Shriver National Institute of Child Health and Human Development Notice of Closed Meeting
Document Number: 2015-19975
Type: Notice
Date: 2015-08-14
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
National Institute of Nursing Research Notice of Meeting
Document Number: 2015-19974
Type: Notice
Date: 2015-08-14
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
Notice of Availability of the Draft Environmental Assessment for HHS/CDC Lawrenceville Campus Proposed Improvements 2015-2025, Lawrenceville, Georgia
Document Number: 2015-19861
Type: Notice
Date: 2015-08-14
Agency: Energy Policy and New Uses Office, Agriculture Department, Defense Nuclear Facilities Safety Board
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announces the availability and opportunity for public review and comment of the Draft Environmental Assessment (Draft EA) for the HHS/CDC Lawrenceville Campus Proposed Improvements 2015-2025 on the HHS/CDC Lawrenceville Campus, Lawrenceville, Georgia. The Draft EA has been prepared in accordance with the National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), the Council on Environmental Quality (CEQ) implementing regulations (40 CFR 1500-1508) and the HHS General Administration Manual (GAM) Part 30 Environmental Procedures, dated February 25, 2000.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2015-19947
Type: Notice
Date: 2015-08-13
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
National Institute on Aging; Notice of Closed Meeting
Document Number: 2015-19946
Type: Notice
Date: 2015-08-13
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
National Institute on Aging; Notice of Closed Meeting
Document Number: 2015-19945
Type: Notice
Date: 2015-08-13
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
National Institute on Aging; Notice of Meeting
Document Number: 2015-19944
Type: Notice
Date: 2015-08-13
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
National Cancer Institute; Amended Notice of Meeting
Document Number: 2015-19943
Type: Notice
Date: 2015-08-13
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
National Cancer Institute; Notice of Closed Meetings
Document Number: 2015-19942
Type: Notice
Date: 2015-08-13
Agency: Energy Policy and New Uses Office, Agriculture Department
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2015-19941
Type: Notice
Date: 2015-08-13
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Meeting
Document Number: 2015-19940
Type: Notice
Date: 2015-08-13
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
Center for Substance Abuse Treatment: Notice of Meeting
Document Number: 2015-19937
Type: Notice
Date: 2015-08-13
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Modernization Commission
Submission for OMB Review; Comment Request
Document Number: 2015-19922
Type: Notice
Date: 2015-08-13
Agency: Energy Policy and New Uses Office, Agriculture Department, Executive Office of the President
Submission for OMB Review; Comment Request
Document Number: 2015-19921
Type: Notice
Date: 2015-08-13
Agency: Energy Policy and New Uses Office, Agriculture Department, Executive Office of the President
Government-Owned Inventions; Availability for Licensing
Document Number: 2015-19912
Type: Notice
Date: 2015-08-13
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.
Adisseo France S.A.S.; Filing of Food Additive Petition (Animal Use)
Document Number: 2015-19884
Type: Proposed Rule
Date: 2015-08-13
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is announcing that Adisseo France S.A.S. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of selenomethionine hydroxy analogue as a source of selenium in feed for chickens, turkeys, swine, dairy cattle, and beef cattle.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2015-19860
Type: Notice
Date: 2015-08-13
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 request entitled ``Efficacy Study of a Mobile Application to Provide Comprehensive and Medically Accurate Sexual Health Information for Adolescent Girls''. The study will examine the efficacy of the mobile application in achieving two behavioral outcomes: Use of effective contraception and clinic utilization.
Occupational Safety and Health Research and Related Activities; Administrative Functions, Practices, and Procedures
Document Number: 2015-19856
Type: Proposed Rule
Date: 2015-08-13
Agency: Energy Policy and New Uses Office, Agriculture Department
The Department of Health and Human Services (HHS) proposes the removal of its regulations pertaining to administrative functions, practices, and procedures for occupational safety and health research and related activities conducted by the National Institute for Occupational Safety and Health (NIOSH) in the Centers for Disease Control and Prevention (CDC). As a part of the retrospective review conducted by all Federal agencies, HHS has determined that these regulations are no longer in use by NIOSH and should be removed.
Privacy Act of 1974; System of Records Notice
Document Number: 2015-19855
Type: Notice
Date: 2015-08-13
Agency: Energy Policy and New Uses Office, Agriculture Department, Defense Logistics Agency
In accordance with the requirements of the Privacy Act of 1974 (5 U.S.C. 552a), HHS is proposing to establish a single, department- wide system of records to cover all HHS payroll records, to be numbered 09-90-1402 and titled ``HHS Payroll Records, HHS/OS.'' The new system will replace two existing systems of records covering payroll records for civilian and commissioned corps personnel (09-40-0006 ``Public Health Service (PHS) Commissioned Corps Payroll Records, HHS/PSC/HRS'' and 09-40-0010 ``Pay, Leave and Attendance Records, HHS/PSC/HRS''). The existing systems were last altered effective September 2012 (see Notice published August 15, 2012 at 77 FR 48984, amending System of Records Notices (SORNs) published December 11, 1998 at 63 FR 68596, to revise the routine use covering disclosures to contractors and to add a new routine use covering disclosures in the course of responding to a data security breach). The existing systems will be considered deleted upon the effective date of the proposed new system. The SORN for the new system includes updates or changes to the System Location, Routine Uses, System Manager, and Record Access Procedure sections, as more fully explained in the ``Supplementary Information'' section of this Notice.
Proposed Collection; 60-Day Comment Request: Scientific Information Reporting System (SIRS) NIGMS
Document Number: 2015-19849
Type: Notice
Date: 2015-08-13
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 General Medical Sciences (NIGMS), the 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 to address 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 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: W. Fred Taylor Ph.D., Acting Director, Center for Research Capacity Building NIGMS, NIH, 45 Center Drive, Room 2AS43S, MSC 6200, Bethesda MD 20892 or call non-toll-free number (301) 594-3900 or Email your request, including your address to: taylorwf@mail.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: Scientific Information Reporting System (SIRS), 0925-NEW, National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH). Need and Use of Information Collection: The SIRS is an online data collection system whose purpose is to obtain supplemental information to the annual Research Performance Progress Report (RPPR) submitted by grantees of the Institutional Development Award (IDeA) Program and the Native American Research Centers for Health (NARCH) Program. The SIRS will collect program-specific data not requested in the RPPR data collection system. The IDeA Program is a congressionally mandated, long-term interventional program administered by NIGMS aimed at developing and/or enhancing the biomedical research competitiveness of States and Jurisdictions that lag in NIH funding. The NARCH Program is an interagency initiative that provides support to American Indian and Alaska Native (AI/AN) tribes and organizations for conducting research in their communities in order to address health disparities, and to develop a cadre of competitive AI/AN scientists and health professionals. The data collected by SIRS will provide valuable information for the following purposes: (1) Evaluation of progress by individual grantees towards achieving grantee-designated and program- specified goals and objectives, (2) evaluation of the overall program for effectiveness, efficiency, and impact in building biomedical research capacity and capability, and (3) analysis of outcome measures to determine need for refinements and/or adjustments of different program features including but not limited to initiatives and eligibility criteria. Data collected from SIRS will be used for various regular or ad hoc reporting requests from interested stakeholders that include members of Congress, state and local officials, other federal agencies, professional societies, media, and other parties. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 613.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2015-19837
Type: Notice
Date: 2015-08-12
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2015-19818
Type: Notice
Date: 2015-08-12
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 (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.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2015-19802
Type: Notice
Date: 2015-08-12
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2015-19799
Type: Notice
Date: 2015-08-12
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 the Prevention Research Centers Program National Evaluation Reporting System. The information collection system is designed to monitor progress on a set of evaluation indicators; demonstrate public health impact and accountability to Congress, CDC leadership, partner organizations, and communities; increase PRC Program visibility; generate knowledge and share information within and outside the PRC Program; and facilitate PRC Program improvement.
National Cancer Institute; Notice of Closed Meetings
Document Number: 2015-19785
Type: Notice
Date: 2015-08-12
Agency: Energy Policy and New Uses Office, Agriculture Department
National Institute on Aging; Notice of Closed Meeting
Document Number: 2015-19784
Type: Notice
Date: 2015-08-12
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
Generic Drug User Fees; Stakeholder Meetings on Generic Drug User Fee Amendments of 2012 Reauthorization; Request for Notification of Stakeholder Intent To Participate; Extension of Closing Date
Document Number: 2015-19768
Type: Notice
Date: 2015-08-12
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is extending the closing date for the document that appeared in the Federal Register of June 3, 2015. In that document, FDA requested that public stakeholders, including patient and consumer advocacy groups, health care professionals, and scientific and academic experts, notify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Generic Drug User Fee Amendments of 2012 (GDUFA). The statutory authority for GDUFA expires at the end of September 2017. At that time, new legislation will be required for FDA to continue collecting user fees for the generic drug program. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next GDUFA program. The FD&C Act also requires that FDA hold continued discussions with patient and consumer advocacy groups at least monthly during FDA's negotiations with the regulated industry. The purpose of the request for notification is to ensure continuity and progress in these monthly discussions by establishing consistent stakeholder representation.
Closed-Circuit Escape Respirators; Extension of Transition Period
Document Number: 2015-19750
Type: Rule
Date: 2015-08-12
Agency: Energy Policy and New Uses Office, Agriculture Department
In March 2012, the Department of Health and Human Services (HHS) published a final rule establishing a new standard for the certification of closed-circuit escape respirators (CCERs) by the National Institute for Occupational Safety and Health (NIOSH) within the Centers for Disease Control and Prevention (CDC). The new standard was originally designed to take effect over a 3-year transition period. HHS has determined that extending the concluding date for the transition is necessary to allow sufficient time for respirator manufacturers to meet the demands of the mining, maritime, railroad and other industries. Pursuant to this final action, NIOSH extends the phase-in period until 1 year after the date that the first approval is granted to certain CCER models.
Head Start Performance Standards; Extension of Comment Period
Document Number: 2015-19747
Type: Proposed Rule
Date: 2015-08-12
Agency: Energy Policy and New Uses Office, Agriculture Department, Executive Office of the President
The Administration for Children and Families extends the comment period for the notice of proposed rulemaking entitled, ``Head Start Performance Standards.'' We take this action to respond to requests from the public for more time to submit comments. The notice of proposed rulemaking and our request for comments appeared in the Federal Register on June 19, 2015. We initially set August 18, 2015 as the deadline for the comment period. To allow the public more time, we extend the comment period for an additional 30 days.
Agency Information Collection Activities; Proposed Collection; Comment Request; Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration
Document Number: 2015-19741
Type: Notice
Date: 2015-08-12
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. This notice solicits comments on the information collection provisions of the recommended labeling of certain beers subject to our labeling jurisdiction.
Guidance for Entities Considering Whether To Register as Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
Document Number: 2015-19740
Type: Notice
Date: 2015-08-12
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
The Food and Drug Administration (FDA) is announcing the availability of a final guidance entitled ``Guidance for Entities Considering Whether to Register as Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' This guidance is intended to inform entities that are considering registering as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as added by the Drug Quality and Security Act (DQSA), of the regulatory implications of registration as an outsourcing facility.
National Institutes of Health Undergraduate Scholarship Program Regarding Professions Needed by National Research Institutes
Document Number: 2015-19739
Type: Rule
Date: 2015-08-12
Agency: Energy Policy and New Uses Office, Agriculture Department
The National Institutes of Health (NIH), through the Department of Health and Human Services (HHS), is issuing regulations to implement provisions of the Public Health Service Act authorizing the NIH Undergraduate Scholarship Program Regarding Professions Needed by National Research Institutes (UGSP). The purpose of the program is to recruit appropriately qualified undergraduate students from disadvantaged backgrounds to conduct research in the intramural research program as employees of the NIH by providing scholarship support.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2015-19735
Type: Notice
Date: 2015-08-12
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
Pediatric Advisory Committee; Notice of Meeting
Document Number: 2015-19729
Type: Notice
Date: 2015-08-12
Agency: Energy Policy and New Uses Office, Agriculture Department, Alcohol, Tobacco, Firearms, and Explosives Bureau
Findings of Research Misconduct; Correction
Document Number: 2015-19738
Type: Notice
Date: 2015-08-11
Agency: Energy Policy and New Uses Office, Agriculture Department, Defense Logistics Agency
This document corrects an error that appeared in the notice published in the July 31, 2015, Federal Register entitled ``Findings of Research Misconduct.''
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2015-19706
Type: Notice
Date: 2015-08-11
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division
National Institute of Mental Health; Notice of Meeting
Document Number: 2015-19705
Type: Notice
Date: 2015-08-11
Agency: Energy Policy and New Uses Office, Agriculture Department, Antitrust Division