August 19, 2011 – Federal Register Recent Federal Regulation Documents

Reader Aids
Document Number: FR-2011-08-19-ReaderAids
Type: Reader Aids
Date: 2011-08-19
Government in the Sunshine Act Meeting Notice
Document Number: 2011-21412
Type: Notice
Date: 2011-08-19
Agency: International Trade Commission, Agencies and Commissions
Keālia Pond National Wildlife Refuge (NWR) and Kakahai'a NWR, Maui County, HI; Draft Comprehensive Conservation Plan and Environmental Assessment
Document Number: 2011-21326
Type: Notice
Date: 2011-08-19
Agency: Fish and Wildlife Service, Department of the Interior
We, the U.S. Fish and Wildlife Service (Service), announce the availability of our draft comprehensive conservation plans and environmental assessments (Draft CCPs/EAs) for the Ke[amacr]lia Pond and Kakahai'a National Wildlife Refuges (Refuges), for public review and comment. The Draft CCPs/EAs describe our proposals for managing the Refuges for the next 15 years.
Approval and Promulgation of Air Quality Implementation Plans; Maryland; Adoption of Plastic Parts and Business Machines Coating Standards
Document Number: 2011-21279
Type: Proposed Rule
Date: 2011-08-19
Agency: Environmental Protection Agency
EPA is proposing to approve a State Implementation Plan (SIP) revision submitted by the State of Maryland (Maryland). This SIP revision includes amendments to the Code of Maryland (COMAR) 26.11.19.07, Volatile Organic Compounds from Specific Processes, Paper, Fabric, Film and Foil Coating, and adds new COMAR 26.11.19.07-2, Plastic Parts and Business Machines Coating. Maryland's SIP revision meets the requirement to adopt Reasonably Available Control Technology (RACT) for sources covered by EPA's Control Techniques Guidelines (CTG) for Miscellaneous Metal and Plastic Parts Coatings and will help Maryland attain and maintain the National Ambient Air Quality Standard (NAAQS) for ozone. This action is being taken under the Clean Air Act (CAA).
Duty-Free Treatment of Certain Visual and Auditory Materials
Document Number: 2011-21275
Type: Proposed Rule
Date: 2011-08-19
Agency: Department of Homeland Security, U.S. Customs and Border Protection, Department of the Treasury, Department of Treasury
This document proposes to amend the U.S. Customs and Border Protection (CBP) regulations pertaining to the filing of documentation related to free entry of certain merchandise under Chapter 98 of the Harmonized Tariff Schedule of the United States (HTSUS). The proposed amendment would permit an applicant to file the documentation required for duty-free treatment of certain visual and auditory materials of an educational, scientific, or cultural character under subheading 9817.00.40, HTSUS, at any time prior to the liquidation of the entry. The regulation currently requires the filing of this documentation within 90 days of the date of entry. The proposed change would provide more time for the importer to provide the necessary certification documentation to CBP and would serve to align the filing of required certification documentation with a change in CBP policy that extended the liquidation cycle for entries in the ordinary course of business from 90 days to 314 days after the date of entry. The change is consistent with other regulations that govern the duty-free treatment of merchandise under Chapter 98, HTSUS.
Notice of Availability of a Draft Programmatic Environmental Impact Statement for Hawaiian Monk Seal Recovery Actions
Document Number: 2011-21274
Type: Notice
Date: 2011-08-19
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS announces the availability of the ``Draft Programmatic Environmental Impact Statement (PEIS) for Hawaiian monk seal Recovery Actions.'' Publication of this notice begins the official public comment period for the Draft PEIS. The purpose of the Draft PEIS is to evaluate, in compliance with the National Environmental Policy Act (NEPA), the potential direct, indirect, and cumulative impacts of implementing the alternative approaches for funding, undertaking, and permitting the management, research and enhancement activities on Hawaiian monk seals, as well as other components of the marine ecosystem and human environment.
Final Policy Statement on the Eligibility of Pedestrian and Bicycle Improvements Under Federal Transit Law
Document Number: 2011-21273
Type: Notice
Date: 2011-08-19
Agency: Federal Transit Administration, Department of Transportation
The Federal Transit Administration (FTA) hereby establishes a formal policy on the eligibility of pedestrian and bicycle improvements for FTA funding and defines the catchment area for pedestrians and bicyclists in relation to public transportation stops and stations.
Approval and Promulgation of Air Quality Implementation Plans; Maryland; Adhesives and Sealants Rule
Document Number: 2011-21272
Type: Proposed Rule
Date: 2011-08-19
Agency: Environmental Protection Agency
EPA is proposing to approve State Implementation Plan (SIP) revisions submitted by the State of Maryland. These SIP revisions pertain to amendments to Maryland's rule for the control of volatile organic compound (VOC) emissions from chemical production and polytetrafluoroethylene (PTFE) operations, from paint, resin, and adhesive manufacturing, and from adhesive and sealant application. These SIP revisions also pertain to an addition of a new regulation for the control of VOC emissions from adhesives and sealants. This action is being taken under the Clean Air Act (CAA).
Announcement of Funding Awards for the Service Coordinators in Multifamily Housing Fiscal Year 2009
Document Number: 2011-21271
Type: Notice
Date: 2011-08-19
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 in a competition for funding under the Super Notice of Funding Availability (SuperNOFA) for the Service Coordinators in Multifamily Housing program. This announcement contains the names of the awardees and the amounts of the awards made available by HUD.
Announcement of Funding Awards for the Assisted Living Conversion Program; Fiscal Year 2009
Document Number: 2011-21269
Type: Notice
Date: 2011-08-19
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 in a competition for funding under the Notice of Funding Availability (NOFA) for the Assisted Living Conversion Program (ALCP). This announcement contains the names of the grantees and the amounts of the awards made available by HUD.
Announcement of Funding Awards for the Section 811 Supportive Housing for Persons With Disabilities Program Fiscal Year 2009
Document Number: 2011-21266
Type: Notice
Date: 2011-08-19
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 in a competition for funding under the Notice of Funding Availability (NOFA) for the Section 811 Supportive Housing for Persons with Disabilities Program. This announcement contains the names of the awardees and the amounts of the awards made available by HUD.
Culturally Significant Objects Imported for Exhibition Determinations: “Modern Antiquity: Picasso, de Chirico, Léger, and Picabia in the Presence of the Antique.”
Document Number: 2011-21264
Type: Notice
Date: 2011-08-19
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 ``Modern Antiquity: Picasso, de Chirico, L[eacute]ger, and Picabia in the Presence of the Antique,'' imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to a loan agreement with the foreign owner or custodian. I also determine that the exhibition or display of the exhibit objects at The J. Paul Getty Museum, the Getty Villa, Pacific Palisades, California, from on or about November 2, 2011, until on or about January 16, 2012, 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. For Further Information Contact: For further information, including a list of the exhibit objects, contact Kevin M. Gleeson, Attorney- Adviser, Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6473). The mailing address is U.S. Department of State, SA-5, L/PD, Fifth Floor (Suite 5H03), Washington, DC 20522-0505.
Proclaiming Certain Lands, Forest Service Lands, as an Addition to the Bay Mills Indian Reservation for the Bay Mills Indian Community of Michigan
Document Number: 2011-21263
Type: Notice
Date: 2011-08-19
Agency: Department of the Interior, Bureau of Indian Affairs, Indian Affairs Bureau
This notice informs the public that the Assistant Secretary Indian Affairs proclaimed approximately 842 acres, more or less, to be added to the Bay Mills Indian Reservation for the Bay Mills Indian Community of Michigan.
Administrative Review of Certain Frozen Warmwater Shrimp From the People's Republic of China: Final Results and Partial Rescission of Antidumping Duty Administrative Review
Document Number: 2011-21259
Type: Notice
Date: 2011-08-19
Agency: Department of Commerce, International Trade Administration
On February 14, 2011, the Department of Commerce (``Department'') published in the Federal Register the Preliminary Results of the fifth administrative review of the antidumping duty order on certain frozen warmwater shrimp from the People's Republic of China (``PRC'').\1\ We gave interested parties an opportunity to comment on the Preliminary Results. Based upon our analysis of the comments and information received, we continue to find that Hilltop \2\ has not sold subject merchandise at less than normal value (``NV'') during the period of review (``POR''), February 1, 2009, through January 31, 2010.
Unlicensed Operation in the TV Broadcast Bands
Document Number: 2011-21258
Type: Notice
Date: 2011-08-19
Agency: Federal Communications Commission, Agencies and Commissions
In this document the Office of Engineering and Technology conditionally designates Microsoft Corporation as TV bands device database administrators. The TV bands databases will be used by fixed and personal portable unlicensed devices to identify unused channels in the spectrum used principally by the broadcast television service that are available at their geographic locations. Microsoft is the tenth entity designated to develop a database that will enable the introduction of this new class of unlicensed broadband wireless devices in the TV spectrum.
Agency Information Collection Activities: Form I-602; Extension of an Existing Information Collection; Comment Request
Document Number: 2011-21256
Type: Notice
Date: 2011-08-19
Agency: Department of Homeland Security, U.S. Citizenship and Immigration Services
Agency Information Collection Activities: Form I-690; Extension of an Existing Information Collection; Comment Request
Document Number: 2011-21255
Type: Notice
Date: 2011-08-19
Agency: Department of Homeland Security, U.S. Citizenship and Immigration Services
Notice of Proposed Information Collection Requests
Document Number: 2011-21254
Type: Notice
Date: 2011-08-19
Agency: Department of Education
The Department of Education (the Department), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the reporting burden on the public and helps the public understand the Department's information collection requirements and provide the requested data in the desired format. The Director, Privacy, Information and Records Management Services, Office of Management, invites comments on the proposed information collection requests as required by the Paperwork Reduction Act of 1995.
Endangered Species; File No. 16548
Document Number: 2011-21253
Type: Notice
Date: 2011-08-19
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
Notice is hereby given that the Springfield Science Museum, 21 Edwards Street, Springfield, Massachusetts 01103 [David J. Stier, Responsible Party], has applied in due form for a permit to hold and transport shortnose sturgeon (Acipenser brevirostrum) for the purposes of enhancement.
Notice of Submission for OMB Review
Document Number: 2011-21252
Type: Notice
Date: 2011-08-19
Agency: Department of Education
The Director, Information Collection Clearance Division, Privacy, Information and Records Management Services, Office of Management, invites comments on the submission for OMB review as required by the Paperwork Reduction Act of 1995 (Pub. L. 104-13).
Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Gulf of Mexico Reef Fish Fishery; 2011 Commercial Quota and 2011 Commercial Fishing Season for Greater Amberjack
Document Number: 2011-21251
Type: Rule
Date: 2011-08-19
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS implements this temporary final rule to increase the commercial quota for greater amberjack in the Gulf of Mexico (Gulf) for the 2011 fishing year and reopen the 2011 commercial fishing season for greater amberjack for a limited time period. These actions are necessary to achieve the optimum yield for the fishery, thus enhancing social and economic benefits to the fishery.
Privacy Act Implementation
Document Number: 2011-21250
Type: Rule
Date: 2011-08-19
Agency: Federal Housing Finance Agency
The Federal Housing Finance Agency (FHFA) is issuing this interim final regulation with a request for comments on changes to its existing Privacy Act regulation. The changes to the existing Privacy Act regulation provide the procedures and guidelines under which FHFA and FHFA Office of Inspector General (FHFA-OIG) will implement the Privacy Act of 1974, as amended (5 U.S.C. 552a) (Privacy Act). The interim final regulation describes the policies and procedures whereby individuals may obtain notification of whether an FHFA or FHFA-OIG system of records contains information about the individual and, if so, how to access or amend a record under the Privacy Act.
Small Takes of Marine Mammals Incidental to Specified Activities; Pile Driving in the Columbia River, WA
Document Number: 2011-21248
Type: Notice
Date: 2011-08-19
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS has received a complete and adequate application from the Port of Vancouver, USA (Port) for an Incidental Harassment Authorization (IHA) to take marine mammals, by harassment, incidental to pile driving during construction of the Terminal 5 Bulk Potash Handling Facility. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is proposing to issue an IHA to incidentally harass, by Level B harassment only, three species of marine mammals during the specified activity within a specific geographic area and is requesting comments on its proposal.
Privacy Act System of Records
Document Number: 2011-21246
Type: Notice
Date: 2011-08-19
Agency: Federal Communications Commission, Agencies and Commissions
Pursuant to subsection (e)(4) of the Privacy Act of 1974, as amended (``Privacy Act''), 5 U.S.C. 552a, the FCC proposes to add one new, consolidated system of records, FCC/OMD-28, ``Time and Attendance Records.'' FCC/OMD-28, ``Time and Attendance Records'' will incorporate the information, i.e., personally identifiable information (PII), presently covered by FCC/OMD-14, ``Pay and Leave Records,'' and FCC/ OMD-21, ``Garnishment and Levy of Wages,'' and also add new and/or updated information that pertains to the responsibilities of the FCC's Human Resources Management (the Agency) division of the Office of Managing Director (OMD). Upon approval of FCC/OMD-30, the Commission will cancel FCC/OMD-14 and FCC/OMD-21. The purposes for adding this new system of records, FCC/OMD-28, ``Time and Attendance Records,'' are for the Agency to use the records in this system primarily to prepare time and attendance records and to certify hours worked/leave earned and leave taken and to administer the FCC's time and attendance/payroll program. These records may also be used to validate and verify hours worked/leave taken/credit hours claimed and to ensure appropriate recordkeeping as well as appropriate expenditure of Federal funds. The new system of records will consolidate FCC/OMD-14 and FCC/OMD-21 that the Agency currently uses so that all the personally identifiable information (PII) in the two information systems are now housed in a single Agency system of records.
Determination That PENTETATE ZINC TRISODIUM (Zinc Trisodium Diethylenetriaminepentaacetate) Solution for Intravenous or Inhalation Administration, Equivalent to 1 Gram Base/5 Milliliters (Equivalent to 200 Milligrams Base/Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2011-21245
Type: Notice
Date: 2011-08-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined that PENTETATE ZINC TRISODIUM (zinc trisodium diethylenetriaminepentaacetate (Zn-DTPA)) solution for intravenous or inhalation administration, equivalent to (EQ) 1 gram (g) base/5 milliliters (mL) (EQ 200 milligrams (mg) base per 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 PENTETATE ZINC TRISODIUM (Zn-DTPA) solution for intravenous or inhalation administration (EQ 1 g base/5 mL (EQ 200 mg base/mL)), if all other legal and regulatory requirements are met.
Draft Guidance for Industry on Standards for Clinical Trial Imaging Endpoints; Availability
Document Number: 2011-21244
Type: Notice
Date: 2011-08-19
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 ``Standards for Clinical Trial Imaging Endpoints.'' The purpose of this draft guidance is to assist sponsors in the use of imaging endpoints in clinical trials of therapeutic drugs and biological products. The draft guidance describes standards sponsors can use to ensure that clinical trial imaging data are obtained in a manner that complies with a trial's protocol, maintains imaging data quality, and provides a verifiable record of the imaging process.
Procurement List Additions And Deletions
Document Number: 2011-21243
Type: Notice
Date: 2011-08-19
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, and deletes products and a service from the Procurement List previously furnished by such agencies.
Procurement List Proposed Addition and Deletions
Document Number: 2011-21242
Type: Notice
Date: 2011-08-19
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 and to delete services previously provided by such agencies. Comments Must be Received on or Before: September 19, 2011.
Agency Information Collection Request. 60-Day Public Comment Request
Document Number: 2011-21241
Type: Notice
Date: 2011-08-19
Agency: Department of Health and Human Services
President's Committee for People With Intellectual Disabilities (PCPID); Notice of Meeting
Document Number: 2011-21240
Type: Notice
Date: 2011-08-19
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Notice of Availability for the Draft Environmental Impact Statement/Environmental Impact Report for a Permit Application for the Proposed Salton Sea Species Conservation Habitat Project at the Salton Sea, in Imperial County, CA
Document Number: 2011-21239
Type: Notice
Date: 2011-08-19
Agency: Department of Defense, Department of the Army, Corps of Engineers, Engineers Corps, Army Department
The U.S. Army Corps of Engineers, Los Angeles District (Regulatory Division), in coordination with the California Natural Resources Agency, has completed a Draft Environmental Impact Statement/ Environmental Impact Report (EIS/EIR) for the Salton Sea Species Conservation Habitat (SCH) Project. The Natural Resources Agency is requesting a permit from the Corps of Engineers to discharge dredged or fill material into the Salton Sea, a water of the United States subject to the Corps jurisdiction under section 404 of the Clean Water Act, including permanent impacts up to 24 acres and temporary impacts up to 1,760 acres for the construction of up to 3,770 acres of shallow ponds and associated infrastructure at the southern end of the Salton Sea in Imperial County, California. Compared to existing conditions, the SCH Project would result in a net increase in the extent of jurisdictional aquatic resources by up to 1,986 acres because the ponds would restore such resources located between elevation -228 feet and -231 feet previously lost by the receding Sea. Draft EIS/EIR Comment Process. In an effort to follow sustainable business practices, the Draft EIS/EIR can be downloaded in electronic format from the Natural Resources AgencyDepartment of Water Resources' Web site: https://www.water.ca.gov/ saltonsea/. A hardcopy of the Draft EIS/EIR and documents referenced in the Draft EIS/EIR can be viewed at the following location: California Department of Fish and Game, 78078 Country Club Drive, Suite 109, Bermuda Dunes, CA 92203. In addition, the hardcopy Draft EIS/EIR can be viewed at the following public locations: Brawley Public Library, 400 Main Street, Brawley, CA 92227; Calipatria Public Library, 225 West Main Street, Calipatria, CA 92233; Imperial Public Library, 200 West 9th Street, Imperial, CA 92251; El Centro Public Library, 375 South 1st Street, El Centro, CA 92243; Imperial County Free Library, 2098 Frontage Road, Salton City, CA 92275; Mecca-North Shore Public Library, 91-260 Avenue 66, Mecca, CA 92254; and Coachella Branch Library, 1538 7th Street, Coachella, CA 92236. The Corps and the Natural Resources Agency invites interested parties to attend one of the jointly held public hearings to provide the agencies with their views and comments on the Draft EIS/EIR. Comments on the content of the Draft EIS/EIR by Federal, State, and local agencies, affected Indian tribes, and other interested organizations and persons are encouraged and will be considered by the Corps and the Natural Resources Agency and become part of the administrative record for the Corps' decision. The public hearings will be held at: 1. CalipatriaSeptember 14, 2011 at 1 P.M. at the Calipatria Inn and Suites, 700 North Sorenson Avenue, Calipatria, CA 92233. 2. BrawleySeptember 14, 2011 at 6 P.M. at Elks Lodge 1420, 161 South Plaza, Brawley, CA 92227. 3. Palm Desert September 15, 2011 at 1 P.M. at the University of California, 75-080 Frank Sinatra Drive, Room B200, Palm Desert, CA 92211. In order for the Corps and the Natural Resources Agency to more accurately process and respond to comments, an online e-form is provided on the Natural Resources AgencyDepartment of Water Resources' Web site https://www.water.ca.gov/saltonsea/ and is the preferred method of receiving comments from interested parties. Alternatively, written comment letters can be provided directly to Ms. Lanika Cervantes or Mr. David Elms at the addresses listed below.
National Library of Medicine Notice of Meeting
Document Number: 2011-21238
Type: Notice
Date: 2011-08-19
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification for a New Dietary Ingredient
Document Number: 2011-21237
Type: Notice
Date: 2011-08-19
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 (the PRA).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substantiation for Dietary Supplement Claims Made Under the Federal Food, Drug, and Cosmetic Act
Document Number: 2011-21236
Type: Notice
Date: 2011-08-19
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.
WTO Dispute Settlement Proceeding Regarding United States-Anti-Dumping Measures on Diamond Sawblades and Parts Thereof From China
Document Number: 2011-21235
Type: Notice
Date: 2011-08-19
Agency: Office of the United States Trade Representative, Trade Representative, Office of United States, Executive Office of the President
The Office of the United States Trade Representative (``USTR'') is providing notice that on July 22, 2011, the People's Republic of China requested consultations with the United States under the Marrakesh Agreement Establishing the World Trade Organization (``WTO Agreement'') concerning anti-dumping measures regarding diamond sawblades and parts thereof from China. That request may be found at https://www.wto.org contained in a document designated as WT/DS422/1/ Add.1. USTR invites written comments from the public concerning the issues raised in China's July 22, 2011 consultation request.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2011-21234
Type: Notice
Date: 2011-08-19
Agency: Department of Health and Human Services, National Institutes of Health
Approval and Promulgation of Air Quality Implementation Plans; Colorado; Revised Definitions; Construction Permit Program Fee Increases; Regulation 3
Document Number: 2011-21233
Type: Rule
Date: 2011-08-19
Agency: Environmental Protection Agency
EPA is approving the two State Implementation Plan (SIP) revision packages submitted by the State of Colorado on August 1, 2007. EPA is approving the August 1, 2007 submittal revisions to Regulation 3, Part A, Section I where the State expanded on the definition of nitrogen dioxide (NO2) to include it as a precursor to ozone. An increase in the amount of the fees charged for pollutant emissions and minor wording additions as specified in Regulation 3, Part A, Section VI.D.1 is approved. EPA is also approving one grammatical change the State made to Regulation 3 in the August 1, 2007 submittal. In addition, EPA is taking no action on several revisions to Colorado's Regulation 3 regarding New Source Review (NSR), that are contained in this submittal, where previously proposed, pending, or future actions by EPA have addressed or will address these revisions. EPA is also not acting on three provisions in the submittals that are not in Colorado's SIP and revisions to the State's requirements to file Air Pollution Emission Notices (APENs). This action is being taken under section 110 of the Clean Air Act (CAA).
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2011-21232
Type: Notice
Date: 2011-08-19
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Research Resources; Notice of Closed Meetings
Document Number: 2011-21231
Type: Notice
Date: 2011-08-19
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Regional Waiver Pursuant to Section 1605 (Buy American Requirement) of the American Recovery and Reinvestment Act of 2009, to Mason County, WA
Document Number: 2011-21230
Type: Notice
Date: 2011-08-19
Agency: Environmental Protection Agency
The Regional Administrator of EPA Region 10 is hereby granting a waiver request from the Buy American requirements of ARRA Section 1605 under the authority of Section 1605(b)(1). This waiver request is being granted because EPA believes it is in the public interest to allow Mason County, Washington (the County) to utilize and install six specific turbo aeration blower units as part of the County's Belfair Wastewater and Water Reclamation Facilities project. This is a project specific waiver and only applies to the use of the specified product for the ARRA project being proposed. Any other ARRA recipient that wishes to use the same product must apply for a separate waiver based on project specific circumstances. The Membrane Bioreactor (MBR) system was selected and procured by the County in 2008 using non-ARRA funding and prior to enactment of ARRA. However, since the MBR equipment is being installed by an ARRA funded contract, the new Buy American requirements of ARRA apply. As ARRA was enacted after the County's procurement actions, the County could not be aware of the need to purchase and install a Buy American compliant MBR system and could not reasonably foresee the need for a waiver. Requiring the installation of domestically manufactured turbo aeration blower units will extend the time frame of the project significantly (by at least four months), due to the redesign, procurement, submittal delivery, submittal review, fabrication, delivery, and replacement of the aeration blower installation at the construction site. Redesign, reconstruction, and replacement of the blowers will likely cost at least an additional $620,000 and could also void the three year manufacturer warranty for the MBR that is valid only if system components identified in the manufacturer's proposal are utilized. A significant delay in the project schedule could push the project past the anticipated September 2011 project completion into the fall rainy season, and could cause runoff over areas of failing septic systems and pose a risk to environmental and water quality protection. This additional cost and delay is inconsistent with the public interest, and a waiver of the Buy American provisions in these circumstances is justified. This action allows the installation of the six specified turbo aeration blower units that have already been delivered to the construction site as noted in Mason County's May 27, 2011, request and additional follow up documentation.
National Institute of Dental & Craniofacial Research; Notice of Meeting
Document Number: 2011-21229
Type: Notice
Date: 2011-08-19
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request; Underground Injection Control (UIC) Program
Document Number: 2011-21228
Type: Notice
Date: 2011-08-19
Agency: Environmental Protection Agency
In compliance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), this document announces that EPA is planning to submit a request to renew an existing approved Information Collection Request (ICR) to the Office of Management and Budget (OMB). This ICR is scheduled to expire on December 31, 2011. Before submitting the ICR to OMB for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection as described in the SUPPLEMENTARY INFORMATION section.
Determination That PENTETATE CALCIUM TRISODIUM (Trisodium Calcium Diethylenetriaminepentaacetate) Solution for Intravenous or Inhalation Administration, Equivalent to 1 Gram Base/5 Milliliters (Equivalent to 200 Milligrams Base/Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2011-21227
Type: Notice
Date: 2011-08-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined that PENTETATE CALCIUM TRISODIUM (trisodium calcium diethylenetriaminepentaacetate (Ca-DTPA)) solution for intravenous or inhalation administration, equivalent to (EQ) 1 gram (g) base/5 milliliters (mL) (EQ 200 milligrams (mg) base/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 PENTETATE CALCIUM TRISODIUM (Ca-DTPA) solution for intravenous or inhalation administration (EQ 1 g base/5 mL (EQ 200 mg base/mL)), if all other legal and regulatory requirements are met.
Draft Guidance for Industry and Food and Drug Administration Staff on In Vitro Companion Diagnostic Devices; Extension of Comment Period
Document Number: 2011-21226
Type: Notice
Date: 2011-08-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is extending to October 12, 2011, the comment period for the notice that appeared in the Federal Register of July 14, 2011 (76 FR 41506). In the notice, FDA requested comments on a draft guidance document entitled ``In Vitro Companion Diagnostic Devices.'' The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Approval and Promulgation of Air Quality Implementation Plans; Ohio; Control of Emissions of Organic Materials That Are Not Regulated by Volatile Organic Compound Reasonably Available Control Technology Rules
Document Number: 2011-21225
Type: Rule
Date: 2011-08-19
Agency: Environmental Protection Agency
EPA is approving, as part of Ohio's State Implementation Plan (SIP) under the Clean Air Act (CAA), a revised rule 3745-21-07, ``Control of emissions of organic materials from stationary sources (i.e., emissions that are not regulated by rule 3745-21-09, 3745-21-12, 3745-21-13, 3745-21-14, 3745-21-15, 3745-21-16, or 3745-21-18 of the Administrative Code).'' This rule has been revised because the prior version of 3745-21-07, in Ohio's SIP, has inadequate compliance test methods and definitions. On February 8, 2008, the previously existing rule 3745-21-07, which was part of Ohio's SIP, was rescinded by Ohio EPA. The most significant problem with the prior version is the definition of ``photochemically reactive material,'' which is different than the definition of ``volatile organic compounds'' (VOC), upon which EPA's reasonably available control technology (RACT) regulations are based. The revised rule is approvable because it satisfies the applicable requirements for VOC sources under the CAA. EPA proposed this rule for approval on April 13, 2011, and received no comments.
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