January 27, 2015 – Federal Register Recent Federal Regulation Documents
Results 1 - 50 of 113
Arctic National Wildlife Refuge, Alaska; Revised Comprehensive Conservation Plan and Final Environmental Impact Statement
We, the U.S. Fish and Wildlife Service (Service), announce the availability of a revised comprehensive conservation plan (plan/CCP) and final environmental impact statement (EIS) for the Arctic National Wildlife Refuge (refuge, NWR) for a 30-day public review. In this revised plan and final EIS, we describe how we propose to manage the refuge for the next 15 years.
Lightweight Thermal Paper From Germany: Notice of Court Decision Not in Harmony With Final Results and Notice of Amended Final Results of Antidumping Duty Administrative Review
On December 31, 2014, the United States Court of International Trade (CIT) entered its final judgment in Papierfabrik August Koehler AG v. United States, Court No. 11-00147, affirming the Department of Commerce's (the Department) final results of redetermination pursuant to remand of the 2008-2009 antidumping duty administrative review of lightweight thermal paper from Germany (Remand Redetermination).\1\ Consistent with the decision of the United States Court of Appeals for the Federal Circuit (CAFC) in Timken Co. v. United States, 893 F.2d 337 (Fed. Cir. 1990) (Timken), as clarified by Diamond Sawblades Mfrs. Coalition v. United States, 626 F.3d 1374 (Fed. Cir. 2010) (Diamond Sawblades), the Department is notifying the public that the final judgment in this case is not in harmony with the Department's final results of the administrative review of the antidumping duty order on lightweight thermal paper from Germany covering the period of review (POR) November 20, 2008, through October 31, 2009,\2\ and is amending the Final Results with respect to the weighted-average dumping margin assigned to Papierfabrik August Koehler AG (Koehler).
Certain Passenger Vehicle and Light Truck Tires From the People's Republic of China: Preliminary Determination of Sales at Less Than Fair Value; Preliminary Affirmative Determination of Critical Circumstances; In Part and Postponement of Final Determination
The Department of Commerce (Department) preliminarily determines that certain Passenger Vehicle and Light Truck Tires (passenger tires) from the People's Republic of China (PRC) are being, or are likely to be, sold in the United States at less than fair value (LTFV), as provided in section 733(b) of the Tariff Act of 1930, as amended (the Act). The period of investigation (POI) is October 1, 2013, through March 31, 2014. The estimated weighted-average dumping margins of sales at LTFV are shown in the ``Preliminary Determination'' section of this notice. Interested parties are invited to comment on this preliminary determination.
Drawn Stainless Steel Sinks From the People's Republic of China: Final Rescission of Antidumping Duty New Shipper Review; 2012-2013
On September 30, 2014, the Department of Commerce (``Department'') published its preliminary intent to rescind the new shipper review (``NSR'') of the antidumping duty order on drawn stainless steel sinks (``drawn sinks'') from the People's Republic of China (``PRC'') covering the period of review (``POR'') of October 4, 2012 through October 14, 2013 for Hubei Foshan Success Imp. & Exp. Co. Ltd. (``Foshan Success'').\1\ Based on our analysis of comments received subsequent to the Preliminary Rescission, the Department continues to find that Foshan Success' sale was not bona fide. As a result, the Department is rescinding this NSR.
Request for Information Regarding an Initiative on Safe Student Banking
The Consumer Financial Protection Bureau (Bureau or CFPB) seeks feedback on a draft Safe Student Account Scorecard that offers information to colleges and universities when soliciting agreements from financial institutions to market safe and affordable financial accounts for their students. The Bureau seeks comment from the public, including student and parent consumers, institutions of higher education, and financial institutions.
International Services Surveys: BE-180, Benchmark Survey of Financial Services Transactions Between U.S. Financial Services Providers and Foreign Persons
This proposed rule would amend regulations of the Bureau of Economic Analysis (BEA), Department of Commerce, to reinstate reporting requirements for the BE-180, Benchmark Survey of Financial Services Transactions between U.S. Financial Services Providers and Foreign Persons. Benchmark surveys are conducted every five years; the prior survey covered 2009. For the 2014 benchmark survey, BEA proposes one change in the data items collected. This mandatory survey would be conducted under the authority of the International Investment and Trade in Services Survey Act (the Act). Unlike most other BEA surveys conducted pursuant to the Act, a response would be required from persons subject to the reporting requirements of the BE-180, Benchmark Survey of Financial Services Transactions between U.S. Financial Services Providers and Foreign Persons, whether or not they are contacted by BEA, to ensure complete coverage of financial services transactions between U.S. financial services providers and foreign persons.
Tapered Roller Bearings and Parts Thereof, Finished and Unfinished, From the People's Republic of China: Final Results of the Antidumping Duty Administrative Review and Final Results of the New Shipper Review; 2012-2013
On July 23, 2014, the Department of Commerce (the Department) published the preliminary results and partial rescission of the 26th administrative review and the preliminary results of one new shipper review (NSR) of the antidumping duty order on tapered roller bearings and parts thereof, finished and unfinished (TRBs), from the People's Republic of China (PRC).\1\ The period of review (POR) is June 1, 2012, through May 31, 2013. Based on our analysis of the comments received, we have made certain changes in the margin calculations. Therefore, the final results differ from the preliminary results. The final weighted- average dumping margins for the reviewed firms are listed below in the section entitled ``Final Results of the Reviews.''
Agency Information Collection Activities: Harbor Maintenance Fee
U.S. Customs and Border Protection (CBP) of the Department of Homeland Security 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: Harbor Maintenance Fee. This is a proposed extension of an information collection that was previously approved. CBP is proposing that this information collection be extended with no change to the burden hours or to the information collected. This document is published to obtain comments from the public and affected agencies.
Ball Bearings and Parts Thereof From Japan and the United Kingdom: Final Results of Antidumping Duty Administrative Reviews; 2010-2011
On September 23, 2014, the Department of Commerce (the Department) published the preliminary results of the administrative reviews of the antidumping duty orders on ball bearings and parts thereof from Japan and the United Kingdom.\1 2\ The period of review (POR) is May 1, 2010, through April 30, 2011. For these final results, we continue to find that sales of the subject merchandise have been made at prices below normal value.
Information Collection; Submission for OMB Review, Comment Request
The Corporation for National and Community Service (CNCS) has submitted a public information collection request (ICR) entitled 2015 Pay for Success Grant Opportunity for review and approval in accordance with the Paperwork Reduction Act of 1995, Public Law 104-13, (44 U.S.C. Chapter 35). Copies of this ICR, with applicable supporting documentation, may be obtained by calling the Corporation for National and Community Service, Jennifer Stoff, at 202-606-7570 or email to jstoff@cns.gov. Individuals who use a telecommunications device for the deaf (TTY-TDD) may call 1-800-833-3722 between 8 a.m. and 8 p.m. Eastern Time, Monday through Friday.
Agency Information Collection Activities: Lien Notice
U.S. Customs and Border Protection (CBP) of the Department of Homeland Security 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: Lien Notice (CBP Form 3485). This is a proposed extension of an information collection that was previously approved. CBP is proposing that this information collection be extended with no change to the burden hours or to the information collected. This document is published to obtain comments from the public and affected agencies.
Federal Guidance Report No. 14: Radiation Protection Guidance for Diagnostic and Interventional X-Ray Procedures
This document announces the availability of the U.S. Environmental Protection Agency's (EPA) updated Federal Guidance Report No. 14: Radiation Protection Guidance for Diagnostic and Interventional X-Ray Procedures (EPA 402-R-10003, November 2014). Federal Guidance Report No. 14 provides federal facilities that use diagnostic and interventional x-ray equipment with recommendations for keeping patient doses as low as reasonably achievable without compromising the quality of patient care.
Land Acquisitions; Transfer of Excess Federal Real Property
This notice provides notification of the Department of the Interior's final agency determination to acquire approximately 226.49 acres, more or less, of land into trust for the Cherokee Nation. This notice is published in the exercise of authority delegated by the Secretary of the Interior to the Assistant SecretaryIndian Affairs by 209 Department Manual 8.1.
Corrections to Points Awarded for Competitive Preference Priorities and Updated Links to Two Studies; Student Support Services Program
On December 18, 2014, we published a notice in the Federal Register (79 FR 75722) inviting applications for new awards for fiscal year (FY) 2015 for the SSS Program. The U.S. Department of Education (Department) is providing corrections to the point allocation information for Competitive Preference Priority (CPP) 1(a)Influencing the Development of Non-Cognitive Factors; CPP 1(b)Strategies to Influence the Development of Non-Cognitive Factors Supported by Moderate Evidence of Effectiveness; and CPP 2(a)Providing Individualized Counseling for Personal, Career, and Academic Matters. In addition, the Department is providing updated links to two studies associated with the CPPs.
Texas-New Mexico Regional Meeting of the Binational Bridges and Border Crossings Group
Delegates from the United States and Mexican Governments, the states of Texas and New Mexico, and the Mexican states of Chihuahua, Coahuila, Nuevo Leon, and Tamaulipas will participate in the Texas-New Mexico Regional meeting of the U.S.-Mexico Binational Bridges and Border Crossings Group on February 5, 2015, in Austin Texas. The purpose of this meeting is to discuss operational matters involving existing and proposed international bridges and border crossings and their related infrastructure, and to exchange views on policy as well as technical information. This meeting includes a public session on Thursday, February 5, 2015, from 8:30 a.m. until 11:00 a.m. This session allows proponents of proposed bridges and border crossings and related projects to make presentations to the delegations and members of the public.
Advisory Committee on the Medical Uses of Isotopes: Meeting Notice
NRC will convene a meeting of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) on March 19-20, 2015. A sample of agenda items to be discussed during the public session includes: (1) An update on the staff's efforts related to the release of patients administered radioactive material; (2) an update on medical-related events; (3) a discussion on the use of iodine-125 and palladium-103 seeds for localization of non-palpable lesions; (4) a discussion related to the decommissioning funding plan for germanium/gallium-68 generators; (5) a discussion on the compatibility category for permanent brachytherapy reportable medical events; (6) an update on the Abnormal Occurrence Criteria, and (7) an update on title 10 of the Code of Federal Regulations (10 CFR) part 35 Proposed Rule. The agenda is subject to change. The current agenda and any updates will be available at https://www.nrc.gov/reading-rm/doc-collections/acmui/meetings/ 2015.html or by emailing Ms. Sophie Holiday at the contact information below. Purpose: Discuss issues related to 10 CFR part 35 Medical Use of Byproduct Material. Date and Time for Open Sessions: March 19, 2015, from 8:30 a.m. to 5 p.m. and March 20, 2015, from 8:30 a.m. to 12:15 p.m. Address for Public Meeting: U.S. Nuclear Regulatory Commission, Two White Flint North Building, Room T2-B3, 11545 Rockville Pike, Rockville, Maryland 20852. Public Participation: Any member of the public who wishes to participate in the meeting in person or via phone should contact Ms. Holiday using the information below. The meeting will also be webcast live: video.nrc.gov. Contact Information: Sophie J. Holiday, email: sophie.holiday@nrc.gov, telephone: (301) 415-7865.
Culturally Significant Object Imported for Exhibition Determinations: “Sword Pommel”
Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, et seq.; 22 U.S.C. 6501 note, et seq.), Delegation of Authority No. 234 of October 1, 1999, and Delegation of Authority No. 236-3 of August 28, 2000 (and, as appropriate, Delegation of Authority No. 257 of April 15, 2003), I hereby determine that the object to be included in the exhibition ``Sword Pommel,'' imported from abroad for temporary exhibition within the United States, is of cultural significance. The object is imported pursuant to a loan agreement with the foreign owner or custodian. I also determine that the exhibition or display of the exhibit object at the Metropolitan Museum of Art, New York, New York, from on or about February 1, 2015, until on or about February 1, 2020, and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these Determinations be published in the Federal Register.
Culturally Significant Objects Imported for Exhibition Determinations: “Ireland: Crossroads of Art and Design, 1690-1840”
Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, et seq.; 22 U.S.C. 6501 note, et seq.), Delegation of Authority No. 234 of October 1, 1999, and Delegation of Authority No. 236-3 of August 28, 2000 (and, as appropriate, Delegation of Authority No. 257 of April 15, 2003), I hereby determine that the objects to be included in the exhibition ``Ireland: Crossroads of Art and Design, 1690-1840,'' imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at the Art Institute of Chicago, Chicago, Illinois, from on or about March 17, 2015, until on or about July 7, 2015, and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these Determinations be published in the Federal Register.
Agency Information Collection Activities: Suspensions Pending Appeal and Bonding-OMB Control Number 1012-0006; Comment Request
Final regulations that ONRR published May 13, 1999 (64 FR 26240, RIN 1010-AC21), govern the appeal of orders from Minerals Management Service's Royalty Management Program (now ONRR). To comply with the Paperwork Reduction Act of 1995 (PRA), ONRR is notifying the public that we have submitted to the Office of Management and Budget (OMB) an information collection request (ICR) to renew approval of the paperwork requirements in the regulations under 30 CFR part 1243. This notice provides the public a second opportunity to comment on the burden of these regulatory requirements.
Culturally Significant Objects Imported for Exhibition Determinations: “Coypel's Don Quixote Tapestries: Illustrating a Spanish Novel in 18th-Century France”
Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, et seq.; 22 U.S.C. 6501 note, et seq.), Delegation of Authority No. 234 of October 1, 1999, and Delegation of Authority No. 236-3 of August 28, 2000 (and, as appropriate, Delegation of Authority No. 257 of April 15, 2003), I hereby determine that the objects to be included in the exhibition ``Coypel's Don Quixote Tapestries: Illustrating a Spanish Novel in 18th-Century France,'' imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at The Frick Collection, New York, New York, from on or about February 25, 2015, until on or about May 17, 2015, and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these Determinations be published in the Federal Register.
Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Coastal Migratory Pelagic Resources in the Gulf of Mexico and Atlantic Region; Amendment 20B
NMFS issues this final rule to implement Amendment 20B to the Fishery Management Plan for the Coastal Migratory Pelagic Resources (CMP) in the exclusive economic zone (EEZ) of the Gulf of Mexico and Atlantic Region (FMP) (Amendment 20B), as prepared and submitted by the Gulf of Mexico (Gulf) and South Atlantic Fishery Management Councils (Councils). This rule modifies Gulf migratory group king mackerel trip limits and fishing years, allows transit through areas closed to king mackerel fishing, creates zones and quotas for Atlantic migratory group king and Spanish mackerel, modifies the framework procedures for the FMP, increases annual catch limits (ACLs) and annual catch targets (ACTs) for cobia, and creates an east coast zone and quotas for Gulf migratory group cobia. In addition, this rule reorganizes the description of CMP zones in the regulations and clarifies that spearguns and powerheads are allowable gear for cobia in Federal waters of the South Atlantic and Mid-Atlantic regions. The purpose of this rule is to help achieve optimum yield (OY) for the CMP fishery while ensuring allocations are fair and equitable and fishery resources are utilized efficiently.
Notice of Intent To Terminate 214 Authorization
This notice serves as final opportunity for ACT Telecommunications, Inc. (ACT) to respond to the Department of Justice, the Federal Bureau of Investigation, and the Department of Homeland Security (Agencies) request that the Commission terminate and declare null, void and no longer in effect, the international 214 authorization issued to ACT by the Commission. The Agencies state that ACT has failed to comply with commitments and undertakings with these Agencies, which is a condition on the 214 authorization issued by the Commission. The FCC now provides final notice to ACT that it intends to declare ACT's international 214 authorization terminated for failure to comply with conditions of its authorization.
Notice of Intent To Terminate 214 Authorization
This notice serves as final opportunity for Wypoint Telecom, Inc. (Wypoint) to respond to the Department of Justice, the Federal Bureau of Investigation, and the Department of Homeland Security (Agencies) request that the Commission terminate and declare null, void and no longer in effect, the international 214 authorization issued to Wypoint by the Commission. The Agencies state that Wypoint has failed to comply with commitments and undertakings with these Agencies, which is a condition on the 214 authorization issued by the Commission. The FCC now provides final notice to Wypoint that it intends to declare Wypoint's international 214 authorization terminated for failure to comply with conditions of its authorization.
Notice of Revocation of Customs Broker's License
This document provides notice of the revocation of a customs broker's license.
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''.
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