2012 – Federal Register Recent Federal Regulation Documents

Results 851 - 900 of 29,268
Order Granting Conditional Exemptions Under the Securities Exchange Act of 1934 in Connection With Portfolio Margining of Swaps and Security-Based Swaps
Document Number: 2012-30553
Type: Notice
Date: 2012-12-19
Agency: Securities and Exchange Commission, Agencies and Commissions
The Securities and Exchange Commission (``SEC'' or ``Commission'') is issuing an order granting conditional exemptive relief from compliance with certain provisions of the Securities Exchange Act of 1934 (``Exchange Act'') in connection with a program to commingle and portfolio margin customer positions in cleared credit default swaps (``CDS''), which include both swaps and security-based swaps, in a segregated account established and maintained in accordance with Section 4d(f) of the Commodity Exchange Act (``CEA'').
AllianceBernstein Active ETFs, Inc., et al.; Notice of Application
Document Number: 2012-30551
Type: Notice
Date: 2012-12-19
Agency: Securities and Exchange Commission, Agencies and Commissions
Summary of Application: Applicants request an order that would permit: (a) series of certain open-end management investment companies to issue shares (``Shares'') redeemable in large aggregations only (``Creation Units''); (b) secondary market transactions in Shares to occur at negotiated market prices; (c) certain series to pay redemption proceeds, under certain circumstances, more than seven days from the tender of Shares for redemption; (d) certain affiliated persons of the series to deposit securities into, and receive securities from, the series in connection with the purchase and redemption of Creation Units; and (e) certain registered management investment companies and unit investment trusts outside of the same group of investment companies as the series to acquire Shares.\1\
Federal Acquisition Regulation; Accelerated Payments to Small Business Subcontractors
Document Number: 2012-30550
Type: Proposed Rule
Date: 2012-12-19
Agency: Department of Defense, General Services Administration, Agencies and Commissions, National Aeronautics and Space Administration
DoD, GSA, and NASA are proposing to amend the Federal Acquisition Regulation (FAR) to implement the temporary policy provided by Office of Management and Budget (OMB) Policy Memorandum M-12-16, dated July 11, 2012, by adding a new clause to provide for the accelerated payments to small business subcontractors.
Agency Information Collection Activities: Proposed Collection; Comment Request-Generic Clearance To Conduct Formative Research
Document Number: 2012-30549
Type: Notice
Date: 2012-12-19
Agency: Department of Agriculture, Food and Nutrition Service
In accordance with the Paperwork Reduction Act of 1995, this notice invites the general public and other interested parties to comment on a proposed information collection. This collection is an extension, without change, of a currently approved collection. This information collection will conduct research in support of FNS' goal of delivering science-based nutrition education to targeted audiences. From development through testing of materials and tools with the target audience, FNS plans to conduct data collections that involve formative research including focus groups, interviews (dyad, triad, telephone, etc.), surveys and Web-based collection tools.
The Adams Express Company and Petroleum & Resources Corporation; Notice of Application
Document Number: 2012-30548
Type: Notice
Date: 2012-12-19
Agency: Securities and Exchange Commission, Agencies and Commissions
Summary of Application: Applicants request an order to permit certain registered closed-end investment companies to make periodic distributions of long-term capital gains with respect to their outstanding common shares as frequently as monthly in any one taxable year, and as frequently as distributions are specified by or in accordance with the terms of any outstanding preferred shares that such investment companies may issue.
Agency Information Collection Activities: Proposed Collection; Comment Request-Summer Food Service Program
Document Number: 2012-30543
Type: Notice
Date: 2012-12-19
Agency: Department of Agriculture, Food and Nutrition Service
In accordance with the Paperwork Reduction Act of 1995, this notice invites the general public and other public agencies to comment on the Agency's proposed information collection for the Summer Food Service Program. This collection is a revision of a currently approved information collection.
Notice of Receipt of Kinder Morgan Cochin, LLC, Application for a Presidential Permit To Operate and Maintain Pipeline Facilities on the Border of the United States and Canada
Document Number: 2012-30542
Type: Notice
Date: 2012-12-19
Agency: Department of State
Notice is hereby given that the Department of State (DOS) has received from Kinder Morgan Cochin, LLC (``KM Cochin'') notice that by way of corporate succession, KM Cochin now owns, operates, and maintains pipeline facilities (``Cochin Pipeline'') previously owned by Dome Pipeline Corporation (``Dome Pipeline'') and permitted under a 1974 Presidential Permit issued to Dome Pipeline. KM Cochin requests a new Presidential Permit be issued under its name with respect to the Cochin Pipeline. KM Cochin is a Delaware limited liability company with its principal office at 500 Dallas Street Suite 1000, Houston, TX 77002. It is engaged in the interstate, intrastate and international transportation by pipeline of light liquid hydrocarbons, including transportation of light liquid hydrocarbons between the United States and Canada on the Cochin Pipeline crossing the border of North Dakota and Saskatchewan. KM Cochin is an indirectly wholly owned subsidiary of KMP, a Delaware master limited partnership listed on the NYSE as ``KMP'', with its principal office at 500 Dallas Street, Suite 1000, Houston, TX 77002. The general partner of KMP is Kinder Morgan G.P., Inc., (``KMGP'') a Delaware corporation, which is owned by Kinder Morgan, Inc., (``KMI'', as listed on the NYSE), a Delaware corporation. KMP is owned by KMI through common and class B limited partner units, by KMG though its 1% general partner interest, and by public investors as limited partners holding common units purchased on the NYSE. Dome Pipeline built, operated and maintained the pipeline pursuant to the 1974 Permit from the date the Permit was issued until March 15, 2007, when Dome Petroleum Corp., a North Dakota corporation with principal offices in Bismarck, North Dakota, sold Dome Pipeline, its former subsidiary, to Kinder Morgan Operating L.P. ``A'' (``KMOLPA''), a Delaware limited partnership and affiliate of Kinder Morgan Energy Partners LP, (``KMP''), a Delaware limited partnership, both with principal offices in Houston, Texas. Following the sale, Dome Pipeline was converted from a Delaware corporation to a Delaware limited liability company and merged into KM Cochin, which is now the legal name of the former Dome Pipeline Corporation. Since March 15, 2007, KM Cochin has owned, operated and maintained the Cochin Pipeline in compliance with all the terms and conditions of the previously issued Permit. The Cochin Pipeline is a 1,819 mile, 12-inch diameter pipeline that originates in Fort Saskatchewan, Alberta, and terminates at Windsor, Ontario. Cochin is presently approved by the Department of Transportation's Pipeline and Hazardous Materials Safety Administration (PHMSA) to operate at a pressure of 1,000 psi, and is able to transport up to 95,000 barrels per day of light liquid hydrocarbons. Currently, the pipeline is used to move propane from Alberta to distribution terminals in the United States and Windsor, Ontario. A planned Cochin reversal project will involve reversing the flow of petroleum liquids so that shippers will be able to ship condensate from the United States westward for delivery into Canada. Under E.O. 13337 the Secretary of State is designated and empowered to receive all applications for Presidential Permits for the construction, connection, operation, or maintenance at the borders of the United States, of facilities for the exportation or importation of liquid petroleum, petroleum products, or other non-gaseous fuels to or from a foreign country. The Department of State is circulating this application to concerned federal agencies for comment. The Department of State has the responsibility to determine whether issuance of a new Presidential Permit reflecting the change in ownership or control of the Cochin Pipeline would be in the U.S. national interest.
Culturally Significant Objects Imported for Exhibition Determinations: “Wait, Later This Will Be Nothing: Editions by Dieter Roth”
Document Number: 2012-30541
Type: Notice
Date: 2012-12-19
Agency: Department of State
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 ``Wait, Later This Will Be Nothing: Editions by Dieter Roth,'' 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 Museum of Modern Art, New York, New York, from on or about February 13, 2013, until on or about June 24, 2013, 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.
30-Day Notice of Proposed Information Collection: Application for Employment as a Locally Employed Staff or Family Member
Document Number: 2012-30540
Type: Notice
Date: 2012-12-19
Agency: Department of State
The Department of State has submitted the information collection described below to the Office of Management and Budget (OMB) for approval. In accordance with the Paperwork Reduction Act of 1995 we are requesting comments on this collection from all interested individuals and organizations. The purpose of this Notice is to allow 30 days for public comment.
60-Day Notice of Proposed Information Collection: Gilman Evaluation Survey
Document Number: 2012-30539
Type: Notice
Date: 2012-12-19
Agency: Department of State
The Department of State is seeking Office of Management and Budget (OMB) approval for the information collection described below. In accordance with the Paperwork Reduction Act of 1995, we are requesting comments on this collection from all interested individuals and organizations. The purpose of this notice is to allow 60 days for public comment preceding submission of the collection to OMB.
60-Day Notice of Proposed Information Collection: ECA Exchange Student Surveys
Document Number: 2012-30538
Type: Notice
Date: 2012-12-19
Agency: Department of State
The Department of State is seeking Office of Management and Budget (OMB) approval for the information collection described below. In accordance with the Paperwork Reduction Act of 1995, we are requesting comments on this collection from all interested individuals and organizations. The purpose of this notice is to allow 60 days for public comment preceding submission of the collection to OMB.
Submission for OMB Review; Comment Request
Document Number: 2012-30536
Type: Notice
Date: 2012-12-19
Agency: Department of Commerce
Submission for OMB Review; Comment Request
Document Number: 2012-30535
Type: Notice
Date: 2012-12-19
Agency: Department of Commerce
Certain Electronic Devices Having a Retractable USB Connector; Termination of an Investigation
Document Number: 2012-30534
Type: Notice
Date: 2012-12-19
Agency: International Trade Commission, Agencies and Commissions
Notice is hereby given that the U.S. International Trade Commission has determined not to review the presiding administrative law judge's (``ALJ'') initial determination (``ID'') (Order No. 36) terminating the investigation as to the last remaining respondent, and thereby terminating the investigation.
Importation of Sand Pears From China
Document Number: 2012-30532
Type: Rule
Date: 2012-12-19
Agency: Department of Agriculture, Animal and Plant Health Inspection Service
We are amending the fruits and vegetables regulations to allow the importation of sand pears (Pyrus pyrifolia) from China into the United States. As a condition of entry, sand pears from areas in China in which the Oriental fruit fly (Bactrocera dorsalis) is not known to exist will have to be produced in accordance with a systems approach that includes requirements for registration of places of production and packinghouses, sourcing of pest-free propagative material, inspection for quarantine pests at set intervals by the national plant protection organization of China, bagging of fruit, safeguarding, labeling, and importation in commercial consignments. Sand pears from areas in China in which Oriental fruit fly is known to exist may be imported into the United States if, in addition to these requirements, the places of production and packinghouses have a monitoring system in place for Oriental fruit fly and the pears are treated with cold treatment. All sand pears from China will also be required to be accompanied by a phytosanitary certificate with an additional declaration stating that all conditions for the importation of the pears have been met and that the consignment of pears has been inspected and found free of quarantine pests. This action will allow for the importation of sand pears from China into the United States while continuing to provide protection against the introduction of quarantine pests.
Schedules of Controlled Substances: Placement of Lorcaserin Into Schedule IV
Document Number: 2012-30531
Type: Proposed Rule
Date: 2012-12-19
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration (DEA) proposes placing the substance lorcaserin, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, into Schedule IV of the Controlled Substances Act (CSA). This proposed action is based on a recommendation from the Assistant Secretary for Health of the Department of Health and Human Services (HHS) and on an evaluation of all other relevant data by DEA. If finalized, this action would impose the regulatory controls and criminal sanctions of Schedule IV on the manufacture, distribution, dispensing, importation, exportation, and possession of lorcaserin and products containing lorcaserin.
National Advisory Committee on Meat and Poultry Inspection
Document Number: 2012-30530
Type: Notice
Date: 2012-12-19
Agency: Department of Agriculture, Food Safety and Inspection Service
Pursuant to the Federal Advisory Committee Act, the Food Safety and Inspection Service (FSIS) is announcing a meeting of the National Advisory Committee on Meat and Poultry Inspection (NACMPI). The Committee is being convened to review two topics for FSIS. The first is strengthening Agency verification activities and guidance concerning sanitary dressing and antimicrobial interventions at veal slaughter operations. FSIS test results show that the percent positive for Shiga toxin-producing Escherichia coli (STEC) from trimmings and ground beef produced from veal are higher than trimmings and ground beef produced from other cattle slaughter classes. FSIS is seeking feedback from NACMPI on improvements FSIS can make to its verification activities related to sanitary dressing and interventions at veal slaughter establishments and improvements it can make to its compliance guidance to address veal slaughter operations. FSIS is also seeking feedback from NACMPI on the ideal outreach strategy for communicating with the veal industry. The second topic is a review of criteria for categorizing FSIS regulations as public health regulations. FSIS has revised its criteria for identifying regulations that are most closely related to public health outcomes. FSIS is seeking input from NACMPI on the criteria and feedback on the proposed approach.
Notice of a Virtual Meeting of the Advisory Committee on Apprenticeship (ACA)
Document Number: 2012-30529
Type: Notice
Date: 2012-12-19
Agency: Employment and Training Administration, Department of Labor
Pursuant to Section 10 of the Federal Advisory Committee Act (FACA) (5 U.S.C. App. 2 Sec. 10), notice is hereby given to announce an open virtual meeting of the Advisory Committee on Apprenticeship (ACA) on January 17, 2013, which can be accessed from the Office of Apprenticeship's (OA) homepage: https://www.doleta.gov/oa/. The ACA is a discretionary committee established by the Secretary of Labor, in accordance with FACA, as amended in 5 U.S.C. App. 2, and its implementing regulations (41 CFR 101-6 and 102-3). All meetings of the ACA are open to the public. A virtual meeting of the ACA provides a cost savings to the government while still offering a venue that allows for public participation and transparency, as required by FACA.
Rescinding Spent Fuel Pool Exclusion Regulations
Document Number: 2012-30528
Type: Proposed Rule
Date: 2012-12-19
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) has received a petition for rulemaking from the Commonwealth of Massachusetts (Commonwealth or petitioner) requesting that the NRC rescind its regulations excluding consideration of spent fuel pool storage impacts from license renewal environmental review. The petition was filed on June 2, 2011, with the NRC's Atomic Safety Licensing Board (ASLB) in conjunction with a request for a waiver of the NRC's spent fuel pool exclusion regulations. The petitioner requested that, if the ASLB rejected the Commonwealth's waiver petition, the NRC initiate a rulemaking. On November 28, 2011, the ASLB denied the Commonwealth's waiver petition, and on March 8, 2012, in a Commission Memorandum and Order, the petition for rulemaking was referred to NRC staff. The NRC is not requesting public comment period on this petition at this time.
Formations of, Acquisitions by, and Mergers of Savings and Loan Holding Companies
Document Number: 2012-30526
Type: Notice
Date: 2012-12-19
Agency: Federal Reserve System, Agencies and Commissions
Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company
Document Number: 2012-30525
Type: Notice
Date: 2012-12-19
Agency: Federal Reserve System, Agencies and Commissions
Certain Food Containers, Cups, Plates, Cutlery, and Related Items and Packaging Thereof; Commission Determination Not To Review an Initial Determination Granting a Joint Motion To Terminate the Investigation as to Respondents on the Basis of a Settlement Agreement; Termination of Investigation
Document Number: 2012-30524
Type: Notice
Date: 2012-12-19
Agency: International Trade Commission, Agencies and Commissions
Notice is hereby given that the U.S. International Trade Commission has determined not to review the presiding administrative law judge's (``ALJ'') initial determination (``ID'') (Order No. 11) granting a joint motion to terminate the above-captioned investigation as to Respondents Trans World International (New York), Inc., Green Wave International, Inc., and John Calarese & Co. (collectively, the ``Green Wave Respondents'') on the basis of a settlement agreement.
Proposed Collection, Comment Request
Document Number: 2012-30523
Type: Notice
Date: 2012-12-19
Agency: Department of Labor, Bureau of Labor Statistics
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) [44 U.S.C. 3506(c)(2)(A)]. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. The Bureau of Labor Statistics (BLS) is soliciting comments concerning the proposed extension of the ``Multiple Worksite Report and the Report of Federal Employment and Wages.'' A copy of the proposed information collection request (ICR) can be obtained by contacting the individual listed below in the Addresses section of this notice.
Department of Defense Task Force on the Care, Management, and Transition of Recovering Wounded, Ill, and Injured Members of the Armed Forces; Notice of Federal Advisory Committee Meeting
Document Number: 2012-30522
Type: Notice
Date: 2012-12-19
Agency: Department of Defense, Office of the Secretary
Under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150, the Department of Defense announces that the following Federal Advisory Committee meeting of the Department of Defense Task Force on the Care, Management, and Transition of Recovering Wounded, Ill, and Injured Members of the Armed Forces (subsequently referred to as the Task Force) will take place.
Meetings of Humanities Panel
Document Number: 2012-30521
Type: Notice
Date: 2012-12-19
Agency: National Foundation on the Arts and the Humanities, Agencies and Commissions
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C. App.), notice is hereby given that 4 meetings of the Humanities Panel will be held during January, 2013 as follows. The purpose of the meetings is for panel review, discussion, evaluation, and recommendation of applications for financial assistance under the National Foundation on the Arts and Humanities Act of 1965 (20 U.S.C. 951-960, as amended).
Proposed Collection of Information: Medium- and Heavy-Duty Truck Fleet Survey
Document Number: 2012-30520
Type: Notice
Date: 2012-12-19
Agency: National Highway Traffic Safety Administration, Department of Transportation
The National Highway Traffic Safety Administration (NHTSA), on behalf of the Department of Transportation (DOT), invites public comment on our intent to request Office of Management and Budget (OMB) approval to conduct an information collection. This collection of information will be in the form of a one-time survey of medium- and heavy-duty truck fleet managers.
Schedule of Fees for Access to NOAA Environmental Data, Information, and Related Products and Services
Document Number: 2012-30519
Type: Rule
Date: 2012-12-19
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
In this final rule, NESDIS establishes a new schedule of fees for the sale of its data, information, and related products and services to users. NESDIS is revising the fee schedule that has been in effect since 2011 to ensure that the fees accurately reflect the costs of providing access to the environmental data, information, and related products and services. NESDIS is authorized under 15 U.S.C. 1534 to assess fees, up to fair market value, for access to environmental data, information, and products derived from, collected, and/or archived by NOAA. Other than depreciation, costs to upgrade computer hardware and software systems will not be included in the fees charged to users. NESDIS is updating its schedule of fees for access to NOAA Environmental Data, Information, and Related Products and Services as costs of providing access have changed since 2011.
Notice of Approval for South Carolina for Avoidance of 2012 Credit Reduction Under the Federal Unemployment Tax Act
Document Number: 2012-30518
Type: Notice
Date: 2012-12-19
Agency: Employment and Training Administration, Department of Labor
Sections 3302(c)(2) and 3302(d)(3) of the Federal Unemployment Tax Act (FUTA) provide that employers in a state that has an outstanding balance of advances under Title XII of the Social Security Act at the beginning of January 1 of two or more consecutive years are subject to a reduction in credits otherwise available against the FUTA tax for a calendar year, if a balance of advances remains at the beginning of November 10 of that year. Because the account of South Carolina in the Unemployment Trust Fund had a balance of advances at the beginning of January 1 of 2009, 2010, 2011, and 2012, and still had a balance of advances at the beginning of November 10, 2012, South Carolina employers were potentially liable for a reduction in their FUTA offset credit for 2012. Section 3302(g) of FUTA provides that a state may avoid credit reduction for a year by meeting certain criteria. South Carolina applied for avoidance of the 2012 credit reduction under this section. Pursuant to delegation of authority to me under Secretary's Order 06- 2010, I have determined that South Carolina meets all of the criteria of section 3302(g) and thus qualifies for credit reduction avoidance. Therefore, South Carolina employers will have no reduction in FUTA offset credit for calendar year 2012.
Drug Safety and Risk Management Advisory Committee; Notice of Meeting
Document Number: 2012-30517
Type: Notice
Date: 2012-12-19
Agency: Food and Drug Administration, Department of Health and Human Services
Impact of Approved Drug Labeling on Chronic Opioid Therapy; Public Hearing; Request for Comments
Document Number: 2012-30516
Type: Notice
Date: 2012-12-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public hearing to obtain information, particularly scientific evidence, such as study data or peer-reviewed analyses, on issues pertaining to the use of opioid drugs in the treatment of chronic pain.
Silver Nanoparticles (AgNPs); Information and Comment Request
Document Number: 2012-30515
Type: Notice
Date: 2012-12-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), as part of its mission to investigate new and emerging hazards, has initiated an evaluation of the scientific data on silver nanoparticles (AgNPs) to ascertain the potential health risks to workers and to identify gaps in knowledge so that appropriate laboratory and field research studies can be conducted. NIOSH has identified a number of relevant publications on AgNPs. This listing (Evaluation of the scientific data on silver nanoparticles (AgNPs) can be found in Docket CDC-2012-0014 at https://www.regulations.gov. NIOSH is requesting additional information on the following: (1) Published and unpublished reports and findings from in vitro and in vivo toxicity studies with AgNPs, (2) information on possible health effects observed in workers exposed to AgNPs, (3) information on workplaces and products in which AgNPs can be found, (4) description of work tasks and scenarios with a potential for exposure, (5) information on measurement methods and, workplace exposure data, and (6) information on control measures (e.g., engineering controls, work practices, PPE) that are being used in workplaces where potential exposures to AgNPs occur.
Federal Acquisition Regulation; Information Collection; Contract Funding-Limitation of Costs/Funds
Document Number: 2012-30514
Type: Notice
Date: 2012-12-19
Agency: Department of Defense, General Services Administration, Agencies and Commissions, National Aeronautics and Space Administration
Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement concerning limitation of costs/funds. Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of functions of the Federal Acquisition Regulations (FAR), and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance: Emergency Use Authorization of Medical Products
Document Number: 2012-30513
Type: Notice
Date: 2012-12-19
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Comprehensive Assessment of the Process for the Review of Device Submissions; Request for Comments
Document Number: 2012-30511
Type: Notice
Date: 2012-12-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the statement of work for an assessment of the process for the review of medical device submissions. The assessment is part of the FDA performance commitments relating to the Medical Device User Fee Amendments of 2012 (MDUFA III), which reauthorized device user fees for fiscal years 2013-2017. The assessment is described in section V, ``Independent Assessment of Review Process Management'', of the commitment letter entitled ``MDUFA Performance Goals and Procedures'' \1\ (MDUFA III Commitment Letter). The assessment will be conducted by an independent contractor in two phases. FDA is providing a period of 30 days for public comment on the statement of work before requesting proposals for the assessment.
Draft Guidance for Industry on Providing Submissions in Electronic Format-Summary Level Clinical Site Data for Center for Drug Evaluation and Research's Inspection Planning; Availability
Document Number: 2012-30510
Type: Notice
Date: 2012-12-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Providing Submissions in Electronic FormatSummary Level Clinical Site Data for CDER's Inspection Planning.'' The draft guidance is intended to assist applicants in the voluntary submission of a clinical dataset that describes and summarizes the characteristics and outcomes of clinical investigations at the level of the individual study site (summary level clinical site dataset). The summary level clinical site dataset is intended to facilitate use of a risk-based approach to timely identification of clinical investigator sites for onsite inspection by FDA during the review of marketing applications. This draft guidance describes a recommended electronic format for the summary level clinical site dataset to be submitted voluntarily in new drug applications (NDAs), biologics licensing applications (BLAs), and NDA and BLA supplemental applications submitted to FDA's Center for Drug Evaluation and Research (CDER).
Agency Information Collection Activities; Comment Request; Foreign Graduate Medical School Consumer Information Reporting Form
Document Number: 2012-30509
Type: Notice
Date: 2012-12-19
Agency: Department of Education
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing a new information collection.
Notice of Proposed Collection Requests; Comment Request
Document Number: 2012-30508
Type: Notice
Date: 2012-12-19
Agency: Department of Education
On October 18, 2012, the U.S. Department of Education published a 60-day comment period notice in the Federal Register (include Vol. , 77, Page 64111, Column 2) seeking public comment for an information collection entitled, ``Annual Performance Report for the Gaining Early Awareness for Undergraduate Programs.'' ED is extending the comment period to January 4, 2013 due to the public's inability to access the collection at the beginning of the comment period. Please provide comments through regulations.gov site. The Docket ID number is ED-2012-OPE-0036. The Acting Director, Information Collection Clearance Division, Privacy, Information and Records Management Services, Office of Management, hereby issues this extension.
Safety Zone: Gilmerton Bridge Center Span Float-in, Elizabeth River; Norfolk, Portsmouth, and Chesapeake, VA-Correction
Document Number: 2012-30507
Type: Rule
Date: 2012-12-19
Agency: Coast Guard, Department of Homeland Security
On December 11, 2012, the Coast Guard published in the Federal Register an interim temporary final rule establishing a safety zone around the Gilmerton Bridge center span barge. Inadvertently, this rule included an error in the inclement weather date of the safety zone. This document corrects that error.
Notice of Intent To Request Revision and Extension of a Currently Approved Information Collection
Document Number: 2012-30506
Type: Notice
Date: 2012-12-19
Agency: Department of Agriculture, National Agricultural Statistics Service
In accordance with the Paperwork Reduction Act of 1995, this notice announces the intention of the National Agricultural Statistics Service (NASS) to request revision and extension of a currently approved information collection, the Generic Clearance for Survey Research Studies. Revision to burden hours will be needed due to changes in the size of the target population, sampling design, and/or questionnaire length.
Filing Dates for the Illinois Special Election in the 2nd Congressional District
Document Number: 2012-30505
Type: Notice
Date: 2012-12-19
Agency: Federal Election Commission, Agencies and Commissions
Illinois has scheduled elections on February 26, 2013, and April 9, 2013, to fill the U.S. House seat in the 2nd Congressional District vacated by Representative Jesse Jackson, Jr. Committees required to file reports in connection with the Special Primary Election on February 26, 2013, shall file a 12-day Pre-Primary Report. Committees required to file reports in connection with both the Special Primary and Special General Election on April 9, 2013, shall file a 12- day Pre-Primary Report, a 12-day Pre-General Report, and a 30-day Post- General Report.
Submission for OMB Review; Comment Request
Document Number: 2012-30504
Type: Notice
Date: 2012-12-19
Agency: Department of Commerce
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