January 2015 – Federal Register Recent Federal Regulation Documents
Results 401 - 450 of 2,070
Agency Information Collection Activities; Proposed Collection; Comment Request
The information collection requirements described below will be submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act (PRA). The FTC seeks public comments on its proposal to extend, for three years, the current PRA clearance for information collection requirements contained in the rules and regulations under the Fur Products Labeling Act (``Fur Rules''), 16 CFR 301. This clearance expires on April 30, 2015.
Meeting of the Presidential Advisory Council on HIV/AIDS
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service (DHHS) is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA) will hold a meeting to discuss essential health benefits and provider networks, the integration of the Affordable Care Act (ACA) qualified health plan and the Ryan White Program; an update on the National HIV/AIDS Strategy; and a discussion on surveillance data. The meeting will be open to the public.
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Dong Xiao, Ph.D., University of Pittsburgh: Based on the report of an inquiry conducted by the University of Pittsburgh (UP), additional analysis conducted by ORI in its oversight review, and an admission by the Respondent that he had ``intentionally fabricated data contained in a paper entitled `Guggulsterone inhibits prostate cancer growth via inactivation of Akt regulated by ATP citrate signaling,' specifically Figure 6G,'' ORI found that Dr. Dong Xiao, former Research Assistant Professor, Department of Urology, UP, engaged in research misconduct in research supported by National Cancer Institute (NCI), National Institutes of Health (NIH), grant R01 CA157477. ORI found that Respondent engaged in research misconduct by reporting falsified data in Figures 1, 4, 5, S2, and S3 in the following paper published online: Gao, Y., Zeng, Y., Tian, J., Kslam, M.S., Jiang, G., & Xiao, D., ``Gugglesterone inhibits prostate cancer growth via inactivation of Akt regulated by ATP citrate signaling.'' Oncotarget, June 26, 2014 [Epub ahead of print], PMID: 24980815; hereafter referred to as the ``Oncotarget paper.'' Specifically, in the Oncotarget paper, Respondent:
Protection System Maintenance Reliability Standard
Pursuant to the Federal Power Act, the Commission approves a revised Reliability Standard, PRC-005-3 (Protection System and Automatic Reclosing Maintenance), submitted by the North American Electric Reliability Corporation (NERC). In addition, the Commission approves one new definition and six revised definitions referenced in the Reliability Standard, the assigned violation risk factors and violation severity levels, and NERC's implementation plan. Consistent with Order No. 758, the Reliability Standard requires applicable entities to test and maintain certain autoreclosing relays as part of a protection system maintenance program. However, to ensure that proper maintenance and testing is done for all parts of a reclosing relay scheme that can affect the reliable operation of the Bulk-Power System, the Commission directs that NERC develop a modification to the Reliability Standard to include maintenance and testing of supervisory relays.
Policy Statement on Hold Harmless Commitments
The Commission proposes, as a statement of policy, the following clarifications regarding hold harmless commitments offered by applicants as ratepayer protection mechanisms to mitigate adverse effects on rates that may result from transactions subject to section 203 of the Federal Power Act (FPA). First, the Commission proposes to clarify the scope and definition of the costs that should be subject to hold harmless commitments. Second, the Commission proposes to clarify that applicants offering hold harmless commitments must implement controls and procedures to track the costs from which customers will be held harmless. The Commission also proposes to clarify the types of controls and procedures that applicants offering hold harmless commitments must implement. Third, the Commission proposes to no longer accept hold harmless commitments that are limited in duration. Fourth, the Commission proposes to clarify that applicants may demonstrate that, under certain circumstances, transactions will not have an adverse effect on rates without relying on hold harmless commitments or other ratepayer protection mechanisms.
Proposed Collection; 60 Day Comment Request; Evaluation of the NHLBI Proteomics Centers Program: Qualitative Interviews (NHLBI)
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 Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects 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: Pothur Srinivas, Ph.D., Project Officer/ICD Contact, Two Rockledge Center, 6701 Rockledge Drive, Room 10188, MSC 10193, Bethesda, MD 20892, or call non-toll-free number (301) 435-0550, or Email your request to: srinivap@nhlbi.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comments 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: Evaluation of the NHLBI Proteomics Centers Program: Qualitative Interviews 0925-New, National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH). Need and Use of Information Collection: The Proteomics Centers Program was established in 2010 with the goal of applying proteomic approaches to gain a better mechanistic understanding of the physiologic pathways underlying defined clinical conditions related to heart, lung, and blood diseases. The primary goal of the program is to help facilitate a better understanding of the underlying mechanisms in heart, lung, and blood diseases which could contribute to more effective diagnoses, risk stratification, intervention, and prevention. Given the rapid developments in proteomic technologies and approaches in the last five years, it is important to determine the extent to which the efforts of the centers have matured, leading to discovery of new targets for intervention and clinically actionable tool sets. An eighteen-month outcome evaluation will coincide with the completion of funding for the program. This information collection request is being made for one component of this evaluation: Semi-structured interviews with key informants across four targeted groups, internal and external to the program. The results of the evaluation will help determine the extent to which these desired outcomes were achieved as well as to inform future of proteomics research funding and commitments by the NHLBI. The key informant interviews are necessary to understand the perspectives of internal and external program stakeholders as it relates to the success, limitations, and opportunities that can shape future research funding. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 48.
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 038
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: 038'' (Recognition List Number: 038), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Food and Drug Administration/Xavier University PharmaLink Conference-Leadership in a Global Supply Chain
The Food and Drug Administration (FDA) Cincinnati District, in cosponsorship with Xavier University, is announcing a public conference entitled ``FDA/Xavier University PharmaLink Conference: Leadership in a Global Supply Chain.'' The PharmaLink conference seeks solutions to important and complicated issues by aligning with the strategic priorities of FDA and includes presentations from key FDA officials, global regulators, and industry experts. Each presentation challenges the status quo and conventional wisdom to create synergies focused on finding solutions which make a difference. The experience level of the audience has fostered engaged dialog that has led to innovative initiatives. Dates and Times: The public conference will be held on March 25, 2015, from 8:30 a.m. to 5 p.m.; March 26, 2015, from 8:30 a.m. to 5 p.m.; and March 27, 2015, from 8:30 a.m. to 12:45 p.m. Location: The public conference will be held on the campus of Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745- 3073 or 513-745-3020. Contact Persons: For information regarding this notice: Steven Eastham, Food and Drug Administration, Cincinnati South Office, 36 East 7th Street, Cincinnati, OH 45202, 513-246-4134, email: steven.eastham@fda.hhs.gov. For information regarding the conference and registration: Marla Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207- 5471, 513-745-3073, email: phillipsm4@xavier.edu. Registration: There is a registration fee. The conference registration fees cover the cost of the presentations, training materials, receptions, breakfasts, lunches, and dinners for the 2\1/2\ days of the conference. There will be onsite registration. The cost of registration is as follows:
Certain Uncoated Paper From Australia, Brazil, China, Indonesia, and Portugal; Institution of Antidumping and Countervailing Duty Investigations and Scheduling of Preliminary Phase Investigations.
The Commission hereby gives notice of the institution of investigations and commencement of preliminary phase antidumping and countervailing duty investigation Nos. 701-TA-528-529 and 731-TA-1264- 1268 (Preliminary) under sections 703(a) and 733(a) of the Tariff Act of 1930 (19 U.S.C. 1671b(a) and 1673b(a)) (the Act) to determine whether there is a reasonable indication that an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of imports from Australia, Brazil, China, Indonesia, and Portugal of certain uncoated paper, provided for in subheadings 4802.56, 4802.57, 4802.62, and 4802.69 of the Harmonized Tariff Schedule of the United States, that are alleged to be sold in the United States at less than fair value and that are alleged to be subsidized by the Governments of China and Indonesia. Unless the Department of Commerce extends the time for initiation pursuant to sections 702(c)(1)(B) or 732(c)(1)(B) of the Act (19 U.S.C. 1671a(c)(1)(B) or 1673a(c)(1)(B)), the Commission must reach a preliminary determination in antidumping and countervailing duty investigations in 45 days, or in this case by Monday, March 9, 2015. The Commission's views must be transmitted to Commerce within five business days thereafter, or by Monday, March 16, 2015. For further information concerning the conduct of these investigations and rules of general application, consult the Commission's Rules of Practice and Procedure, part 201, subparts A through E (19 CFR part 201), and part 207, subparts A and B (19 CFR part 207).
Notice of Filing of Self-Certification of Coal Capability Under the Powerplant and Industrial Fuel Use Act
On December 18, 2014, Calpine Mid Merit II, LLC, York Energy CenterBlock 2, as owner and operator of an additional new base load electric powerplant, submitted a coal capability self-certification to the Department of Energy (DOE) pursuant to Sec. 201(d) of the Powerplant and Industrial Fuel Use Act of 1978 (FUA), as amended, and DOE regulations in 10 CFR 501.60, 61. FUA and regulations thereunder require DOE to publish a notice of filing of self-certification in the Federal Register. 42 U.S.C. 8311(d) and 10 CFR 501.61(c).
Application To Export Electric Energy; Chubu TT Energy Management Inc.
Chubu TT Energy Management Inc. (Chubu TT) has applied for authority to transmit electric energy from the United States to Canada pursuant to section 202(e) of the Federal Power Act.
Notice of Adjustment of Statewide Per Capita Indicator for Recommending a Cost Share Adjustment
FEMA gives notice that the statewide per capita indicator for recommending cost share adjustments for major disasters declared on or after January 1, 2015, through December 31, 2015, is $136.
Current Good Manufacturing Practice Requirements for Combination Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and FDA staff entitled ``Current Good Manufacturing Practice Requirements for Combination Products.'' The guidance describes and explains the final rule on current good manufacturing practice (CGMP) requirements for combination products, including presenting general considerations for CGMP compliance as well as analysis of hypothetical scenarios.
International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; World Health Organization; Scheduling Recommendations; AH-7921; Gamma-Butyrolactone; 1,4-Butanediol; Ketamine; 9 Additional Substances; Request for Comments
The Food and Drug Administration (FDA) is providing interested persons with the opportunity to submit written comments and to request an informal public meeting concerning recommendations by the World Health Organization (WHO) to impose international manufacturing and distributing restrictions, under international treaties, on certain drug substances. The comments received in response to this notice and/ or public meeting will be considered in preparing the United States position on these proposals for a meeting of the United Nations Commission on Narcotic Drugs (CND) in Vienna, Austria, in March 2015. This notice is issued under the Controlled Substances Act (the CSA).
Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails.'' This guidance is intended to provide recommendations when finalized regarding clinical trial design for medical devices intended either to provide improvement in the appearance of nails affected by onychomycosis or to treat onychomycosis (fungal nail infection). This draft guidance is not final nor is it in effect at this time.
International Conference on Harmonisation; S10 Photosafety Evaluation of Pharmaceuticals; Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``S10 Photosafety Evaluation of Pharmaceuticals.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This guidance outlines details on when photosafety testing is warranted and on possible assessment strategies; it should be read in conjunction with the ICH M3(R2) guidance, section XIV(14) Photosafety Testing. The purpose of the guidance is to recommend international standards for photosafety assessment and to harmonize such assessments that support human clinical trials and marketing authorization for pharmaceuticals. This guidance finalizes the draft guidance issued on February 4, 2013.
Agency Information Collection Activities; Proposed Collection; Comment Request; Biosimilars User Fee Cover Sheet; Form FDA 3792
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection in Form FDA 3792, ``Biosimilars User Fee Cover Sheet''.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Class II Special Controls Guidance Document: Labeling of Natural Rubber Latex Condoms
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 Agency Information Collection
The Department of Energy (DOE) has submitted to the Office of Management and Budget (OMB) for clearance, a proposal for collection of information under the provisions of the Paperwork Reduction Act of 1995. The proposed collection will support a study on how consumers value vehicle fuel economy, compare the current results with those from a similar study conducted in 2003 (published in 2007), and estimate distributions of these valuation processes across the national population of car- owning and car-leasing households. The data derived from this study will be used to provide consumers with information that will help them value increased fuel economy as a means of reducing petroleum consumption, saving money on fuel, and reducing greenhouse gas emissions.
Convention on Supplementary Compensation for Nuclear Damage Contingent Cost Allocation
This notice provides information on a public workshop, scheduled for February 20, 2015, that will discuss the U.S. Department of Energy's December 17, 2014 notice of proposed rulemaking to establish a retrospective risk pooling program under section 934 of the Energy Independence and Security Act of 2007. There will be an opportunity for public comment before and after the public workshop.
National Advisory Committee on Institutional Quality and Integrity: Notice of Membership
The NACIQI is established under Section 114 of the HEA, and is composed of 18 members appointed (A) On the basis of the individuals' experience, integrity, impartiality, and good judgment; (B) From among individuals who are representatives of, or knowledgeable concerning, education and training beyond secondary education, representing all sectors and types of institutions of higher education; and, (C) On the basis of the individuals' technical qualifications, professional standing, and demonstrated knowledge in the fields of accreditation and administration of higher education. The NACIQI meets at least twice a year and provides recommendations to the Secretary of Education pertaining to: The establishment and enforcement of the standards of accrediting agencies or associations under subpart 2 of part H of Title IV, HEA. The recognition of specific accrediting agencies or associations. The preparation and publication of the list of nationally recognized accrediting agencies and associations. The eligibility and certification process for institutions of higher education under Title IV of the HEA. The relationship between (1) accreditation of institutions of higher education and the certification and eligibility of such institutions, and (2) State licensing responsibilities with respect to such institutions. Any other advisory functions relating to accreditation and institutional eligibility that the Secretary may prescribe by regulation.
Notice of Public Meeting, Farmington District Resource Advisory Council Meeting, New Mexico
In accordance with the Federal Land Policy and Management Act and the Federal Advisory Committee Act, the Bureau of Land Management's (BLM) Farmington District Resource Advisory Council (RAC) will meet as indicated below.
Proposed Information Collection (Patient Aligned Care Team (PACT) Telehealth in the Parkinson's Disease Research, Education & Clinical Center (PADRECC), Healthcare Experiences of Patients With Congestive Heart Failure (CHF)) Activity: Comment Request
The Veterans Health Administration (VHA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each new collection, and allow 60 days for public comment in response to the notice. This notice solicits comments on the information needed to evaluate the project aims to enhance PACT implementation by providing education about the needs and experiences of ``Operation Enduring Freedom'' and ``Operation Iraqi Freedom'' (OEF/OIF) Veterans that is emotionally resonant and engaging to learners on a visceral level, as well as promoting a greater sense of alignment with VA's mission of providing patient- centered care.
Proposed Information Collection (From War to Home: Improving Patient-Centered Care and Promoting Empathy for “Operation Enduring Freedom” and “Operation Iraqi Freedom” (OEF/OIF) Veterans in the Veterans Health Administration Patient Aligned Care Team Demo Lab VISN 4) Activity: Comment Request
The Veterans Health Administration (VHA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each new collection, and allow 60 days for public comment in response to the notice. This notice solicits comments on information needed to obtain an accurate and comprehensive assessment of satisfaction of patients who receive mental health care services and on outcomes for Veterans who seek mental health treatment from VHA. Data will allow the program office to ensure that the target audience is being reached, effective treatments are being offered, and tangible, quantitative results are being measured and tracked for continual program improvement.
Proposed Information Collection (Audience Feedback Questionnaire-PACT Demo Lab VISN 4); Comment Request
The Veterans Health Administration (VHA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each new collection, and allow 60 days for public comment in response to the notice. This notice solicits comments on information needed to obtain an accurate and comprehensive assessment of satisfaction of patients who receive mental health care services and on outcomes for Veterans who seek mental health treatment from VHA. Data will allow the program office to ensure that the target audience is being reached, effective treatments are being offered, and tangible, quantitative results are being measured and tracked for continual program improvement.
Agency Information Collection Activities; Proposed eCollection eComments Requested; Revision of a Previously Aapproved Collection COPS Application Package
The Department of Justice (DOJ), Community Oriented Policing Services (COPS) Office, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. This proposed information collection was previously published in the Federal Register at 79 FR 69881, November 24, 2014, allowing for a 60 day comment period.
Agency Information Collection (Supporting Statement for VA Form 10-8678 Application for Annual Clothing Allowance) Activities: Under OMB Review
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Health Administration (VHA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and includes the actual data collection instrument.
Proposed Information Collection (Supplier Perception Survey) Activity; Comment Request
The Office of Acquisition and Logistics (OAL), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each revision of a previously approved collection, and allow 60 days for public comment in response to this notice. This notice solicits comments on the information needed to transform the acquisition and logistics operation.
Networking and Information Technology Research and Development Big Data Strategic Initiative Workshop
The BDSI-2015 Workshop is designed to gather input from private industry, academia, and Federal research laboratories regarding the drafting of a Federal Big Data Research Agenda.
Agency Information Collection (Complaint of Employment Discrimination) Activity Under OMB Review
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-21), this notice announces that the Office of Resolution Management (ORM), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comments. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.
Agency Information Collection Activities: Request for Comments
We (the U.S. Geological Survey) will ask the Office of Management and Budget (OMB) to approve the information collection (IC) described below. The collection will consist of 27 forms. As part of the requested extension we will make several revisions to the number of the associated collection instruments. These revisions include: (1) Deleting USGS Form 9-4053-A, USGS Form 9-4073-A, and USGS Form 9-4097- A; (2) changing USGS Form 9-4094-A and USGS Form 9-4095-A from monthly and annual to annual-only reporting forms; (3) changing USGS Form 9- 4057-A and USGS Form 9-4060-A from quarterly and annual to annual-only reporting forms; and (4) decreasing the average burden time for USGS Form 9-4074-A from 2 hours to 1 hour. As required by the Paperwork Reduction Act (PRA) of 1995, and as part of our continuing efforts to reduce paperwork and respondent burden, we invite the general public and other Federal agencies to take this opportunity to comment on this IC. This collection is scheduled to expire on August 31, 2015.
Agency Information Collection Activities: Affidavit of Support, Forms I-864; I-864A; I-864EZ; I-864W; Revision of a Currently Approved Collection.
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) invites the general public and other Federal agencies to comment upon this proposed revision of a currently approved collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the Federal Register to obtain comments regarding the nature of the information collection, the categories of respondents, the estimated burden (i.e. the time, effort, and resources used by the respondents to respond), the estimated cost to the respondent, and the actual information collection instruments.
Request for Comments on Iceland's Participation in the Environmental Goods Agreement Negotiations
On March 21, 2014, the United States Trade Representative notified Congress of the Administration's intention to enter into negotiations for a World Trade Organization (WTO) Environmental Goods Agreement (EGA) with an initial group of 13 trading partners. The United States Trade Representative has since notified Congress of the Administration's intent to join a consensus among EGA participants to invite the Government of Iceland to join the EGA negotiations. The Office of the U.S. Trade Representative, on behalf of the Trade Policy Staff Committee (TPSC), is seeking public comment regarding U.S. interests and priorities with respect to this initiative to invite Iceland to join the EGA negotiations.
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