July 13, 2012 – Federal Register Recent Federal Regulation Documents

Results 51 - 100 of 139
Dow AgroSciences LLC; Availability of Petition for Determination of Nonregulated Status of Soybean Genetically Engineered for Herbicide Tolerance
Document Number: 2012-17134
Type: Notice
Date: 2012-07-13
Agency: Department of Agriculture, Animal and Plant Health Inspection Service
We are advising the public that the Animal and Plant Health Inspection Service (APHIS) has received a petition from Dow AgroSciences LLC (DAS) seeking a determination of nonregulated status of soybean designated as DAS-44406-6, which has been genetically engineered for tolerance to broadleaf herbicides in the phenoxy auxin group (such as the herbicide 2,4-D) and the herbicides glyphosate and glufosinate. The petition has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms and products. We are making the DAS petition available for review and comment to help us identify potential environmental and interrelated economic issues and impacts that APHIS may determine should be considered in our evaluation of the petition.
Bayer CropScience LP; Availability of a Finding of No Significant Impact and a Preliminary Decision for an Extension of a Determination of Nonregulated Status of Cotton Genetically Engineered for Herbicide Tolerance and Insect Resistance
Document Number: 2012-17133
Type: Notice
Date: 2012-07-13
Agency: Department of Agriculture, Animal and Plant Health Inspection Service
We are advising the public that the Animal and Plant Health Inspection Service has prepared a finding of no significant impact and a preliminary decision regarding a request from Bayer CropScience LP to extend to cotton event T303-3, which has been genetically engineered to be tolerant to the herbicide glufosinate and resistant to several lepidopteran pests, our determination of nonregulated status of TwinLinkTM cotton (event T304-40). We are making available for public comment our finding of no significant impact for the proposed determination of nonregulated status.
Monsanto Co.; Availability of Petition for Determination of Nonregulated Status of Canola Genetically Engineered for Herbicide Tolerance
Document Number: 2012-17132
Type: Notice
Date: 2012-07-13
Agency: Department of Agriculture, Animal and Plant Health Inspection Service
We are advising the public that the Animal and Plant Health Inspection Service (APHIS) has received a petition from the Monsanto Company (Monsanto) seeking a determination of nonregulated status of canola designated as MON 88302, which has been genetically engineered for tolerance to the herbicide glyphosate with more flexibility in the timing of herbicide application. The petition has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms and products. We are making the Monsanto petition available for review and comment to help us identify potential environmental and interrelated economic issues and impacts that APHIS may determine should be considered in our evaluation of the petition.
Announcement of Funding Awards; Fair Housing Initiatives Program Fiscal Year 2012
Document Number: 2012-17131
Type: Notice
Date: 2012-07-13
Agency: Department of Housing and Urban Development
In accordance with section 102(a)(4)(C) of the Department of Housing and Urban Development Reform Act of 1989, this announcement notifies the public of funding decisions made by the Department for funding under the Notice of Funding Availability (NOFA) for the Fair Housing Initiatives Program (FHIP) for Fiscal Year (FY) 2012. This announcement lists the names and addresses of those award recipients selected for funding based on the rating and ranking of all applications and the amount of the awards.
GENECTIVE SA; Availability of Petition for Determination of Nonregulated Status of Maize Genetically Engineered for Herbicide Tolerance
Document Number: 2012-17130
Type: Notice
Date: 2012-07-13
Agency: Department of Agriculture, Animal and Plant Health Inspection Service
We are advising the public that the Animal and Plant Health Inspection Service (APHIS) has received a petition from GENECTIVE SA seeking a determination of nonregulated status of maize designated as VCO-[Oslash]1981-5, which has been genetically engineered for tolerance to the herbicide glyphosate. The petition has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms and products. We are making the GENECTIVE SA petition available for review and comment to help us identify potential environmental and interrelated economic issues and impacts that APHIS may determine should be considered in our evaluation of the petition.
Monsanto Co.; Availability of Petition for Determination of Nonregulated Status of Soybean Genetically Engineered for Herbicide Tolerance
Document Number: 2012-17129
Type: Notice
Date: 2012-07-13
Agency: Department of Agriculture, Animal and Plant Health Inspection Service
We are advising the public that the Animal and Plant Health Inspection Service (APHIS) has received a petition from the Monsanto Company (Monsanto) seeking a determination of nonregulated status of soybean designated as MON 87708, which has been genetically engineered for tolerance to the herbicide dicamba. The petition has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms and products. We are making the Monsanto petition available for review and comment to help us identify potential environmental and interrelated economic issues and impacts that APHIS may determine should be considered in our evaluation of the petition.
Excepted Service
Document Number: 2012-17128
Type: Notice
Date: 2012-07-13
Agency: Office of Personnel Management
This notice identifies Schedule A, B, and C appointing authorities applicable to a single agency that were established or revoked from March 1, 2012, to March 31, 2012.
Dairyland Power Cooperative: CapX 2020 Hampton-Rochester-La Crosse Transmission Line Project
Document Number: 2012-17127
Type: Notice
Date: 2012-07-13
Agency: Department of Agriculture, Rural Utilities Service
Notice is hereby given that the Rural Utilities Service (RUS) has prepared a Final Environmental Impact Statement (EIS) to meet its responsibilities under the National Environmental Policy Act (NEPA), RUS' implementing regulations, 7 CFR 1794, and other applicable environmental requirements related to providing financial assistance to Dairyland Power Cooperative (Dairyland) for its share in the construction of a proposed 345-kilovolt (kV) transmission line and associated infrastructure between Hampton, Minnesota and the La Crosse area in Wisconsin (the proposed project). Dairyland is participating in the proposed project with a number of other utilities (Applicants). The purpose of the proposed project is to: (1) Improve community reliability of the transmission system in Rochester, Winona, La Crosse, and the surrounding areas, which include areas served by Dairyland; (2) improve the regional reliability of the transmission system; and (3) increase generation outlet capacity.
Commercial Mobile Alert System
Document Number: 2012-17125
Type: Rule
Date: 2012-07-13
Agency: Federal Communications Commission, Agencies and Commissions
In this document, the Commission announces that the Office of Management and Budget (OMB) has approved, for a period of three years, the information collection requirements associated with the Commission's Commercial Mobile Alert System (CMS), Second Report and Order (``CMAS Second Report and Order''). This document is consistent with the CMAS Second Report and Order, which stated that the Commission would publish a document in the Federal Register announcing the effective date of those rules.
Prevailing Rate Systems; Abolishment of the Washington, DC, Special Wage Schedule for Printing Positions
Document Number: 2012-17123
Type: Rule
Date: 2012-07-13
Agency: Office of Personnel Management
The U.S. Office of Personnel Management is issuing an interim rule to abolish the Washington, DC, Federal Wage System (FWS) special wage schedule for printing and lithographic positions. Printing and lithographic employees in the Washington, DC, wage area will now be paid from the regular Washington, DC, appropriated fund FWS wage schedule. This change is necessary because Federal employment in printing and lithographic occupations in the Washington, DC, wage area has declined sharply in recent years, and a separate wage schedule is no longer viable or beneficial to employees.
Proposed Collection; Comment Request: Impact of Clinical Research Training and Medical Education at the Clinical Center on Physician Careers in Academia and Clinical Research
Document Number: 2012-17120
Type: Notice
Date: 2012-07-13
Agency: Department of Health and Human Services, National Institutes of Health
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 Clinical Center, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Evaluation of In Vitro Tests for Identifying Eye Injury Hazard Potential of Chemicals and Products: Request for Nominations for an Independent Expert Panel and Submission of Relevant Data
Document Number: 2012-17118
Type: Notice
Date: 2012-07-13
Agency: Department of Health and Human Services
The NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), is planning to convene an independent scientific peer review panel (Panel) to assess the validation status of in vitro tests and integrated non-animal testing strategies proposed for identifying eye injury hazard potential of chemicals and products. On behalf of ICCVAM, NICEATM requests nominations of scientific experts who can be considered for the Panel and submission of data from substances tested in in vitro tests for identifying eye injury hazard potential. Of particular interest are data generated in the short-time exposure (STE) (Takahashi et al., 2008) and isolated rabbit eye (IRE) (ICCVAM, 2006, 2010a) tests and data from approaches using two or more in vitro tests. However, NICEATM requests data from other tests including, but not limited to, the bovine corneal opacity and permeability (BCOP), isolated chicken eye (ICE), hen's egg testchorioallantoic membrane (HET-CAM), Cytosensor microphysiometer (CM), fluorescein leakage (FL), SkinEthicTM human corneal epithelium, and EpiOcularTM tests. If available, corresponding in vivo data for these substances are also requested, including data from any ethical human or animal studies or accidental human exposures.
Aging Management Associated With Wall Thinning Due to Erosion Mechanisms
Document Number: 2012-17117
Type: Notice
Date: 2012-07-13
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC or the Commission) requests public comment on Draft License Renewal Interim Staff Guidance (LR-ISG), LR-ISG-2012-01, ``Wall Thinning Due to Erosion Mechanisms.'' The draft LR-ISG proposes to revise an NRC staff-recommended aging management program (AMP) in NUREG-1801, Revision 2, ``Generic Aging Lessons Learned (GALL) Report,'' and the NRC staff's aging management review procedure and acceptance criteria contained in NUREG-1800, Revision 2, ``Standard Review Plan for Review of License Renewal Applications for Nuclear Power Plants'' (SRP-LR) to address wall thinning due to various erosion mechanisms for piping and components within the scope of the Requirements for Renewal of Operating Licenses for Nuclear Power Plants. This LR-ISG provides changes to the recommendations in GALL Report, Revision 2, AMP XI.M17, ``Flow- Accelerated Corrosion,'' based on the staff's review of several license renewal applications' flow-accelerated corrosion AMPs and stakeholder input.
Update to Notice of Financial Institutions for Which the Federal Deposit Insurance Corporation Has Been Appointed Either Receiver, Liquidator, or Manager
Document Number: 2012-17116
Type: Notice
Date: 2012-07-13
Agency: Federal Deposit Insurance Corporation, Agencies and Commissions
Notice is hereby given that the Federal Deposit Insurance Corporation (Corporation) has been appointed the sole receiver for the following financial institutions effective as of the Date Closed as indicated in the listing. This list (as updated from time to time in the Federal Register) may be relied upon as ``of record'' notice that the Corporation has been appointed receiver for purposes of the statement of policy published in the July 2, 1992 issue of the Federal Register (57 FR 29491). For further information concerning the identification of any institutions which have been placed in liquidation, please visit the Corporation Web site at www.fdic.gov/ bank/individual/failed/banklist.html or contact the Manager of Receivership Oversight in the appropriate service center.
Proposed Technical Standard Order (TSO)-C126b, 406 MHz Emergency Locator Transmitters (ELT) and Notice of Intent To Withdraw TSO Authorizations (TSOA) for TSO-C91a, Emergency Locator Transmitter (ELT) Equipment, and TSO-C126/C126a, 406 MHz Emergency Locator Transmitters (ELT)
Document Number: 2012-17115
Type: Notice
Date: 2012-07-13
Agency: Federal Aviation Administration, Department of Transportation
This notice announces the availability of proposed TSO-C126b and the FAA's intent to withdraw TSO authorizations (TSOA) issued for the manufacture of automatic fixed (AF) and automatic portable (AP) ELTs under TSO-C91a, TSO-C126, and TSO-C126a which incorporate hook and loop fasteners in their design. This proposed action would affect ELT manufacturers. The FAA is not proposing requiring actions on previously installed ELTs. The FAA is taking this action based on its determination that hook and loop fasteners are not an acceptable means of compliance to meet the mounting and retention requirements of current TSOs for ELTs. The FAA is requesting comment on proposed TSO- C126b and the FAA's proposal to withdraw certain other ELT TSOAs.
Request for Public Comment on a Nomination to the Office of Health Assessment and Translation
Document Number: 2012-17114
Type: Notice
Date: 2012-07-13
Agency: Department of Health and Human Services
The NTP requests comments on Air Pollution and Children's Health, which was nominated for a possible evaluation by the Office of Health Assessment and Translation (OHAT). This nomination focuses on substances, mixtures, and exposure circumstances (collectively referred to as ``substances'') related to traffic/near road air pollution and their association with emerging children's health outcomes.
Board of Regents of the Uniformed Services University of the Health Sciences
Document Number: 2012-17111
Type: Notice
Date: 2012-07-13
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) and the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), this notice announces the following meeting of the Board of Regents of the Uniformed Services University of the Health Sciences.
Interagency Task Force on Veterans Small Business Development
Document Number: 2012-17109
Type: Notice
Date: 2012-07-13
Agency: Small Business Administration, Agencies and Commissions
The SBA is issuing this notice to announce the location, date, time, and agenda for the fourth public meeting of the Interagency Task Force on Veterans Small Business Development. The meeting will be open to the public.
Basic Energy Sciences Advisory Committee
Document Number: 2012-17108
Type: Notice
Date: 2012-07-13
Agency: Department of Energy
This notice announces a meeting of the Basic Energy Sciences Advisory Committee (BESAC). Federal Advisory Committee Act (Pub. L. 92- 463, 86 Stat. 770) requires that public notice of these meetings be announced in the Federal Register.
Notice of Utah's Resource Advisory Council (RAC)/Recreation Resource Advisory Council (RRAC) Meeting
Document Number: 2012-17107
Type: Notice
Date: 2012-07-13
Agency: Department of the Interior, Bureau of Land Management
In accordance with the Federal Land Policy and Management Act and the Federal Advisory Committee Act of 1972, the Department of the Interior, Bureau of Land Management's (BLM) Utah Resource Advisory Council (RAC)/Recreation Resource Advisory Council (RRAC) will meet as indicated below.
Information Collection Being Reviewed by the Federal Communications Commission
Document Number: 2012-17106
Type: Notice
Date: 2012-07-13
Agency: Federal Communications Commission, Agencies and Commissions
The Federal Communications Commission (FCC), as part of its continuing effort to reduce paperwork burdens, invites the general public and other Federal agencies to take this opportunity to comment on the following information collection, as required by the Paperwork Reduction Act (PRA) of 1995. Comments are requested concerning whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.
Notice of Petitions by Firms for Determination of Eligibility To Apply for Trade Adjustment Assistance
Document Number: 2012-17102
Type: Notice
Date: 2012-07-13
Agency: Department of Commerce, Economic Development Administration
Submission for OMB Review; Comment Request
Document Number: 2012-17101
Type: Notice
Date: 2012-07-13
Agency: Department of Commerce
Proposed Information Collection; Comment Request; 2013 Alternative Contact Strategy Test
Document Number: 2012-17099
Type: Notice
Date: 2012-07-13
Agency: Department of Commerce, U.s. Census Bureau
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)).
Notice of Public Meetings for the Draft Environmental Impact Statement for the Proposed Modernization and Expansion of Townsend Bombing Range, GA
Document Number: 2012-17098
Type: Notice
Date: 2012-07-13
Agency: Department of Defense, Department of the Navy
Pursuant to Section (102)(2)(c) of the National Environmental Policy Act of 1969 (NEPA) (42 United States Code [U.S.C.] Sections 4321-4370h); the Council on Environmental Quality (CEQ) regulations for implementing the procedural provisions of NEPA (Title 40 Code of Federal Regulations (CFR) Parts 1500-1508); Department of the Navy Procedures for Implementing NEPA (32 CFR part 775); and Marine Corps NEPA directives (Marine Corps Order P5090.2A), the U. S. Marine Corps (USMC)as prepared and filed with the U.S. Environmental Protection Agency (EPA) a Draft Environmental Impact Statement (EIS) that evaluates potential environmental impacts of acquiring additional property and constructing the necessary infrastructure to allow the use of inert precision-guided munitions (PGMs) at Townsend Bombing Range (TBR), Georgia. Through the use of PGMs at TBR, the USMC can more efficiently meet current training requirements for pilots by significantly increasing air-to-ground training capabilities for Marine Air Group (MAG) 31 stationed at Marine Corps Air Station (MCAS) Beaufort, South Carolina. With the filing of the Draft EIS, the USMC is initiating a 45-day public comment period and has scheduled two public open house meetings to receive oral and written comments on the Draft EIS. Federal, state and local agencies and interested parties are encouraged to provide comments in person at the public meetings, or in writing anytime during the public comment period. This notice announces the dates and locations of the public meetings and provides supplementary information about the environmental planning effort.
FOIA Fee Schedule Update
Document Number: 2012-17097
Type: Rule
Date: 2012-07-13
Agency: Defense Nuclear Facilities Safety Board, Agencies and Commissions
The Defense Nuclear Facilities Safety Board is publishing its Freedom of Information Act (FOIA) Fee Schedule Update pursuant to the Board's regulations.
Procurement List; Additions
Document Number: 2012-17095
Type: Notice
Date: 2012-07-13
Agency: Committee for Purchase From People Who Are Blind or Severely Disabled, Agencies and Commissions
This action adds products and services to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.
Procurement List; Proposed Addition
Document Number: 2012-17094
Type: Notice
Date: 2012-07-13
Agency: Committee for Purchase From People Who Are Blind or Severely Disabled, Agencies and Commissions
The Committee is proposing to add a service to the Procurement List that will be furnished by a nonprofit agency employing persons who are blind or have other severe disabilities.
Agency Information Collection Activities; Proposed Information Collection; Comment Request; Correction
Document Number: 2012-17093
Type: Notice
Date: 2012-07-13
Agency: Committee for Purchase From People Who Are Blind or Severely Disabled, Agencies and Commissions
On Tuesday, July 3, 2012, the Committee published a Notice in Federal Register Volume 77, Number 128, Page 39486 of its intent to submit to the Office of Management and Budget for its review an information collection concerning Committee Forms 403 and 404. The date cited, July 28, 2009, for persons interested in submitting comments about the collection was incorrect and should have read July 28, 2012.
Proposed Information Collection; Comment Request; Limits on Applications of Take Prohibitions
Document Number: 2012-17092
Type: Notice
Date: 2012-07-13
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Determination That CHLOROMYCETIN (Chloramphenicol) Capsules, 250 Milligrams, Were Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2012-17091
Type: Notice
Date: 2012-07-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined that CHLOROMYCETIN (chloramphenicol) Capsules, 250 milligrams (mg), were withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for chloramphenicol capsules, 250 mg.
Determination That TOPOTECAN INJECTION (Topotecan Hydrochloride) 1 Milligram (Base)/1 Milliliter, 3 Milligram (Base)/3 Milliliter, 4 Milligram (Base)/4 Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2012-17090
Type: Notice
Date: 2012-07-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined that TOPOTECAN INJECTION (topotecan hydrochloride) 1 milligram (mg) (base)/1 milliliter (mL), 3 mg (base)/3 mL, 4 mg (base)/4 mL, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for topotecan hydrochloride intravenous solution 1 mg (base)/1 mL, 3 mg (base)/3 mL, 4 mg (base)/4 mL, if all other legal and regulatory requirements are met.
Single-Ingredient, Immediate-Release Drug Products Containing Oxycodone for Oral Administration and Labeled for Human Use; Enforcement Action Dates; Correction
Document Number: 2012-17089
Type: Notice
Date: 2012-07-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of July 6, 2012 (77 FR 40069). The document announced FDA's intention to take enforcement action against all unapproved single-ingredient, immediate-release drug products that contain oxycodone hydrochloride for oral administration and are labeled for human use, and persons who manufacture or cause the manufacture or distribution of such products in interstate commerce. The document was published with an incorrect Web link. This document corrects that error.
Agency Information Collection Activities: Comment Request
Document Number: 2012-17088
Type: Notice
Date: 2012-07-13
Agency: Department of the Interior, U.s. Geological Survey
To comply with the Paperwork Reduction Act of 1995 (PRA), we are notifying the public that we will submit to OMB an information collection request (ICR) to renew approval of the paperwork requirements for ``Bird Banding Lab (4 USGS forms).'' This notice provides the public and other Federal agencies an opportunity to comment on the paperwork burden of this form. This collection is scheduled to expire on November 30, 2012.
Privacy Act of 1974 System of Records Notice
Document Number: 2012-17087
Type: Notice
Date: 2012-07-13
Agency: Commodity Futures Trading Commission, Agencies and Commissions
The Commodity Futures Trading Commission (Commission) is revising one system of records under the Privacy Act of 1974: CFTC-44, Personnel Security Files, to be renamed CFTC-44, Personnel Clearance System. The Commission also is establishing two new systems of records: CFTC-48, Personal Property Claims, and CFTC-49, Whistleblower Records (Exempted). Revisions to CFTC-44 incorporate enhancements to the system of records with a new streamlined process of capturing personal information, minimizing paper records and eliminating manual entry into a legacy application when an individual applies for a security clearance. New CFTC-48 addresses information collected through a new process for employees to file and have adjudicated claims for damage or loss of certain personal property, as stated in Commission policies and applicable law. New CFTC-49 addresses information collected for the Commission's whistleblower program, which is described and defined in Section 23 of the Commodity Exchange Act, 7 U.S.C. 26, and the rules promulgated thereunder, 17 CFR part 165.
Safety Zone; Newburgh to Beacon Swim, Newburgh, Hudson River, NY
Document Number: 2012-17085
Type: Rule
Date: 2012-07-13
Agency: Coast Guard, Department of Homeland Security
The Coast Guard is establishing a temporary safety zone on the navigable waters of the Hudson River, NY in the vicinity of Newburgh, NY for the annual Newburgh Beacon Swim event. This temporary safety zone is necessary to protect swimmers, spectators and vessels from the hazards associated with swimmers competing in a swim across the Hudson River. Persons and vessels are prohibited from entering into, transiting through, or anchoring within the safety zone unless authorized by the Captain of the Port (COTP) New York or the designated representative.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2012-17084
Type: Notice
Date: 2012-07-13
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Gulf of Mexico Fishery Management Council; Public Meetings
Document Number: 2012-17083
Type: Notice
Date: 2012-07-13
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The Gulf of Mexico Fishery Management Council will convene three web based meetings of the ABC Control Rule Working Group.
Regulatory Science Considerations for Medical Countermeasure Radiation Biodosimetry Devices
Document Number: 2012-17082
Type: Notice
Date: 2012-07-13
Agency: Food and Drug Administration, Department of Health and Human Services
Statement of Cooperation Between the Food and Drug Administration and the Secretaria of Health of the United Mexican States: Safety and Sanitary Quality of Fresh and Frozen Molluscan Shellfish Exported From Mexico to the United States
Document Number: 2012-17081
Type: Notice
Date: 2012-07-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is providing notice of a Statement of Cooperation (SOC) between FDA and Secretariat of Health (SS) of the United Mexican States, through the Federal Commission for Protection from Sanitary Risks (COFEPRIS). The purpose of the SOC is to safeguard public health and to ensure the safety and sanitary quality of fresh and frozen molluscan shellfish harvested from aquacultured and wild populations that are now or may be exported into the United States.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document; Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle
Document Number: 2012-17080
Type: Notice
Date: 2012-07-13
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Request for Samples and Protocols
Document Number: 2012-17079
Type: Notice
Date: 2012-07-13
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.
Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices: The Pre-Submission Program and Meetings With FDA Staff; Availability
Document Number: 2012-17078
Type: Notice
Date: 2012-07-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Medical Devices: The Pre- Submission Program and Meetings with FDA Staff.'' The purpose of this guidance is to describe the Pre-Submission program (formerly the pre- Investigational Device Exemption (IDE) program) for medical devices reviewed in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). In addition, the guidance provides recommendations regarding information that should be included in a Pre-Submission Package. This guidance also describes the procedures that CDRH and CBER intend to follow when industry representatives or application sponsors request a meeting with review staff. This draft guidance is not final nor is it in effect at this time.
Food and Drug Administration/Xavier University Global Outsourcing Conference
Document Number: 2012-17077
Type: Notice
Date: 2012-07-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) Cincinnati District, in cosponsorship with Xavier University, is announcing a public conference entitled ``FDA/Xavier University Global Outsourcing Conference.'' This public conference for the pharmaceutical industry is in direct alignment with the ``FDA Strategic Priorities 2011-2015,'' and includes presentations from key FDA officials, global regulators, and industry experts. This conference drives collaboration on the topic of global outsourcing compliance by bringing pharmaceutical/biotechnology companies and contract partners to the same event to address the issues that reside on both sides of the contract. Expert presentations address the ``how to'' aspects of improving outsourced product quality through topics such as FDA International Initiatives, FDA Inspection Trends, Supply Chain Development, Quality Agreements, Supplier Qualification, and many more. The experience level of our audience has fostered engaged dialogue that has led to innovative initiatives. Dates and Times: The public conference will be held on September 24, 2012, from 8:30 a.m. to 5 p.m.; September 25, 2012, from 8:30 a.m. to 5:30 p.m.; and September 26, 2012, 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 513-745-3396. Contact Persons: For information regarding this notice: Steven Eastham, Food and Drug Administration, Cincinnati South Office, 36 East Seventh 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, 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. Early registration ends August 5, 2012. Standard registration ends September 2, 2012. Late registration occurs September 3 to September 23, 2012. There will also be onsite registration. The cost of registration is as follows:
Submission for OMB Review; Comment Request
Document Number: 2012-17076
Type: Notice
Date: 2012-07-13
Agency: Securities and Exchange Commission, Agencies and Commissions
Submission for OMB Review; Comment Request
Document Number: 2012-17075
Type: Notice
Date: 2012-07-13
Agency: Securities and Exchange Commission, Agencies and Commissions
Submission for OMB Review; Comment Request
Document Number: 2012-17074
Type: Notice
Date: 2012-07-13
Agency: Securities and Exchange Commission, Agencies and Commissions
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