April 11, 2012 – Federal Register Recent Federal Regulation Documents

Reader Aids
Document Number: FR-2012-04-11-ReaderAids
Type: Reader Aids
Date: 2012-04-11
Continuation of the National Emergency With Respect to Somalia
Document Number: 2012-8907
Type: Administrative Order
Date: 2012-04-11
Agency: Executive Office of the President
Board of Governors; Sunshine Act Meeting
Document Number: 2012-8868
Type: Notice
Date: 2012-04-11
Agency: Postal Service, Agencies and Commissions
National Science Board; Sunshine Act Meeting
Document Number: 2012-8862
Type: Notice
Date: 2012-04-11
Agency: National Science Foundation, Agencies and Commissions
Savage, Bingham & Garfield Railroad Company-Trackage Rights Exemption-Elgin, Joliet and Eastern Railway Company
Document Number: 2012-8804
Type: Notice
Date: 2012-04-11
Agency: Surface Transportation Board, Department of Transportation
New England Fishery Management Council; Public Meeting
Document Number: 2012-8774
Type: Notice
Date: 2012-04-11
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The New England Fishery Management Council (Council) will hold an evening public hearing on Wednesday, April 25, 2012 to obtain public input on measures proposed for inclusion in Amendment 5 to the Atlantic Herring Fishery Management Plan.
Endangered Species; File Nos. 13599 and 1614
Document Number: 2012-8773
Type: Notice
Date: 2012-04-11
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
Notice is hereby given that National Ocean Service Marine Forensic Lab [Responsible Party: Julie Carter], 219 Fort Johnson Road, Charleston, SC 29412 [Permit No. 13599], and the NOAA Fisheries Northeast Region Protected Resources Division [Responsible Party: Mary Colligan], One Blackburn Drive, Gloucester, MA 01930 [Permit No. 1614], have been issued modifications to their scientific research permits.
Risk Adjustment Meeting-May 7, 2012 and May 8, 2012
Document Number: 2012-8771
Type: Notice
Date: 2012-04-11
Agency: Department of Health and Human Services
This notice announces a meeting on the risk adjustment program, which is open to the public. The purpose of this meeting is to provide information to States, issuers, and interested parties about the risk adjustment program. This meeting will include the following topics: The risk adjustment model, calculation of plan average actuarial risk, calculation of payments and charges, data collection approach, and the schedule for running risk adjustment. This meeting will provide an opportunity to hear from a variety of interested parties as the Federal risk adjustment methodology is being developed and we are working through operational issues.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2012-8768
Type: Notice
Date: 2012-04-11
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Agreements Filed
Document Number: 2012-8767
Type: Notice
Date: 2012-04-11
Agency: Federal Maritime Commission, Agencies and Commissions
Notice of Submission of Proposed Information Collection to OMB Consolidated Plan and Annual Performance Report
Document Number: 2012-8765
Type: Notice
Date: 2012-04-11
Agency: Department of Housing and Urban Development
The proposed information collection requirement described below has been submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal. The Department's collection of this information is in compliance with statutory provisions of the Cranston Gonzalez National Affordable Housing Act of 1990 that requires participating jurisdictions to submit a Comprehensive Housing Affordability Strategy (Section 105(b)); the 1974 Housing and Community Development Act, as amended, that requires states and localities to submit a Community Development Plan (Section 104(b)(4) and Section 104(m)); and statutory provisions of these Acts that requires states and localities to submit applications and reports for these formula grant programs. The information is needed to provide HUD with preliminary assessment as to the statutory and regulatory eligibility of proposed grantee projects and for informing citizens of intended uses of program funds.
Privacy Act of 1974; System of Records
Document Number: 2012-8764
Type: Notice
Date: 2012-04-11
Agency: Department of Justice
Pursuant to the provisions of the Privacy Act of 1974 (5 U.S.C. 552a), the United States Department of Justice (``DOJ'' or ``Department'') Drug Enforcement Administration (DEA) proposes to modify JUSTICE/DEA-008, ``Investigative Reporting and Filing System'' (``IRFS''). IRFS was last published in its entirety in the Federal Register at 61 FR 54219, Oct. 17, 1996. The Department proposes to modify IRFS to update, add to, and/or clarify the system location, the categories of individuals covered by the system, the categories of records in the system, the authorities for the maintenance of the system, the purposes of the system, the system's routine uses, the policies and practices for storing, retrieving, accessing, retaining, and disposing of records in the system, the system manager, the notification procedures, the record access procedures, the contesting record procedures, the record source categories, and the exemptions claimed for the system. These changes are made in the wake of legislative changes, to improve mandated cooperation between law enforcement and intelligence entities, and to reflect the modernization of DEA's information systems.
Notice of Submission of Proposed Information Collection to OMB Single Family Mortgage Insurance on Hawaiian Homelands
Document Number: 2012-8762
Type: Notice
Date: 2012-04-11
Agency: Department of Housing and Urban Development
The proposed information collection requirement described below has been submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal. FHA insures mortgages on single-family dwellings under provisions of the National Housing Act (12 U.S.C. 1709). The Housing and Urban Rural Recovery Act (HURRA), Public Law 98- 181, amended the National Housing Act to add Section 247 (12 U.S.C. 1715z-12) to permit FHA to insure mortgages for properties located on Hawaiian Homelands. Under this program, the mortgagor must be a native Hawaiian. Section 247 requires that the Department of Hawaiian Homelands (DHHL) of the State of Hawaii (a) will be a co-mortgagor; (b) guarantees or reimburses the Secretary for any mortgage insurance claim paid in connection with a property on Hawaiian homelands; or (c) offers other security acceptable to the Secretary. In accordance with 24 CFR 203.43i, the collection of information is verification that a loan applicant is a native Hawaiian and that the applicant holds a lease on land in a Hawaiian Homelands area. A borrower must obtain verification of eligibility from DHHL and submit it to the lender. A borrower cannot obtain a loan under these provisions without proof of status as a native Hawaiian. United States citizens living in Hawaii are not eligible for this leasehold program unless they are native Hawaiians. The eligibility document is required to obtain benefits. In accordance with 24 CFR 203.439(c), lenders must report monthly to HUD and the DHHL on delinquent borrowers and provide documentation to HUD to support that the loss mitigation requirements of 24 CFR 203.604 have been met. To assist the DHHL in identifying delinquent loans, lenders report monthly. A delinquent mortgage that is reported timely would allow DHHL to intervene and prevent foreclosure. This collection of data is cited in 2502-0060.
Notice of Submission of Proposed Information Collection to OMB Public Housing Agency Plan
Document Number: 2012-8760
Type: Notice
Date: 2012-04-11
Agency: Department of Housing and Urban Development
The proposed information collection requirement described below has been submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal. The PHA Plan is a comprehensive guide to PHA policies, programs, operations, and strategies for meeting local housing needs and goals. The PHA Plan informs HUD, residents, and the public of the PHA's mission for serving the needs of low, very low-income, and extremely low-income families and its strategy for addressing those needs. This data allows HUD to monitor the performance of programs and the performance of public housing agencies that administer the programs. The PHA Plan is being revised to address, clarify and provide additional guidance on the submission requirements for qualified and nonqualified PHAs, as well as to address previous public comments. Section 2702 of Title VIISmall Public Housing Authorities Paperwork Reduction Act, of the Housing and Economic Recovery Act (HERA) of 2008 amends section 5A(b) of the 1937 Act by establishing ``qualified public housing agencies,'' a category of PHAs with less than 550 public housing units and tenant-based vouchers combined that are provided substantial paperwork relief, primarily with respect to the PHA Annual Plan requirements in section 5(A)(b) of the United States Housing Act of 1937. The paperwork relief exempts qualified PHAs from the requirement to prepare and submit an annual PHA plan to HUD for review. This Act impacts approximately seventy-four percent, or 2,994 of the 4,053 PHAs that are required to submit an annual PHA plan. In addition to the exemption from submitting annual plans for qualified agencies, because of the different annual plan submission requirements of agencies that are considered standard, high-performer, Housing Choice Voucher (HCV) only, small, and troubled within 24 CFR part 903, the existing approved forms were determined to be incompatible with the program requirements. Therefore, some previously approved forms have been separated into new forms that will be completed by different classes of PHAs. These changes also reflect recommendations made by the public in a previous information collection. Specifically, this information collection revises previously approved OMB forms HUD-50077- SL and HUD-50077-CR; adds Certifications of Compliance with PHA Plans and Related Regulations (form HUD-50077-SM-HP and HUD-50077-ST-HCV) formerly appearing on form HUD 50077 as separate documents; deletes approved OMB form HUD-50075, and replaces that form with five new forms (form HUD-50075-5Y, HUD-50075-ST, HUD-50075-SM-HP, HUD-50075-HCV, and HUD-50075-QA). Qualified PHAs no longer submit information on discretionary programs (demolition or disposition, HOPE VI, Project- based vouchers, required or voluntary conversion, homeownership, or capital improvements, etc.) as part of an Annual PHA Plan submission. However, Qualified PHAs that intend to implement these activities are still subject to the full application and approval processes that exist for demolition or disposition, designated housing, conversion, homeownership, and other special application processes that will no longer be tied to prior authorization in an Annual PHA Plan for a Qualified PHA. All PHAs, including the PHAs identified as Qualified PHAs under HERA, must continue to submit any demolition or disposition, public housing conversion, homeownership, or other special applications as applicable to HUD's Special Applications Center (SAC) in Chicago for review and approval or to HUD Headquarters for CFFP proposals. It is expected that Qualified PHAs, as a matter of good business practice, continue to keep their residents, the general public, and the local HUD office apprised of any plans to initiate these types of programs and activities.
Announcement of Requirements and Registration for “Reporting Patient Safety Events Challenge”
Document Number: 2012-8758
Type: Notice
Date: 2012-04-11
Agency: Department of Health and Human Services
Patient Safety Organizations (PSOs) listed by the Agency for Healthcare Research and Quality (AHRQ) create a safe environment for health care providers to collect, aggregate, and analyze data without fear of legal discovery. Hospitals struggle to increase internal incident reporting, especially by busy physicians and nurses, and to create effective systems for the quality and risk management staff to do root cause analyses and follow-up. The ``Reporting Patient Safety Events Challenge'' asks multi-disciplinary teams to develop an application that facilitates the reporting of patient safety events, whether implemented in hospital or ambulatory settings. The solution needs to make it easier for any individual to file a report electronically, using Common Formats but allowing for additional elements and narratives. It must allow the hospital quality and risk management staff to add information from follow-up investigation, submit reports as appropriate to PSOs, the state, or the FDA (which may differ, and need to be tracked separately), and track follow-up activities. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111- 358).
Notice of Proposed Information Collection for Public Comment; Loan Guarantee for Indian Housing
Document Number: 2012-8755
Type: Notice
Date: 2012-04-11
Agency: Department of Housing and Urban Development
The proposed information collection requirement described below will be submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal. Information collected determines if the Department will guarantee loans and mortgage insurance made by private lenders to Native American borrowers on ``Indian areas.''
Endangered Species; File Nos. 16526, 16323, 16436, 16422, 16438, 16431, 16507, 16547, 16375, 16442, 16482, and 16508
Document Number: 2012-8752
Type: Notice
Date: 2012-04-11
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
Notice is hereby given that twelve applications have been issued permits to take Atlantic sturgeon (Acipenser oxyrinchus oxyrinchus) for purposes of scientific research. See SUPPLEMENTARY INFORMATION for additional information regarding permittees.
Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Salmon
Document Number: 2012-8750
Type: Proposed Rule
Date: 2012-04-11
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS proposes regulations to implement Amendment 12 to the Fishery Management Plan for Salmon Fisheries in the EEZ off the Coast of Alaska (FMP). If approved, Amendment 12 would comprehensively revise and update the FMP to reflect the North Pacific Fishery Management Council's (Council's) salmon management policy and to comply with Federal law. This proposed rule is necessary to revise specific regulations and remove obsolete regulations in accordance with the modifications proposed by Amendment 12. These proposed regulations are intended to promote the goals and objectives of the Magnuson-Stevens Fishery Conservation and Management Act, the FMP, and other applicable laws.
Advisory Committee on the Electronic Records Archives (ACERA).
Document Number: 2012-8746
Type: Notice
Date: 2012-04-11
Agency: National Archives and Records Administration, Agencies and Commissions
In accordance with the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), the National Archives and Records Administration (NARA) announces a meeting of the Advisory Committee on the Electronic Records Archives (ACERA). The committee serves as a deliberative body to advise the Archivist of the United States, on technical, mission, and service issues related to the Electronic Records Archives (ERA). This includes, but is not limited to, advising and making recommendations to the Archivist on issues related to the development, implementation and use of the ERA system. This meeting will be open to the public. However, due to space limitations and access procedures, the name and telephone number of individuals planning to attend must be submitted to the Electronic Records Archives Program at era.program@nara.gov. This meeting will be recorded for transcription purposes.
Certain Kitchen Appliance Shelving and Racks From the People's Republic of China: Final Results and Partial Rescission of First Antidumping Duty Administrative Review
Document Number: 2012-8736
Type: Notice
Date: 2012-04-11
Agency: Department of Commerce, International Trade Administration
On October 11, 2011, the Department of Commerce (``Department'') published in the Federal Register the preliminary results of the first administrative review of the antidumping duty order on certain kitchen appliance shelving and racks 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 have made changes to the margin calculations for the final results. We continue to find that certain exporters have sold subject merchandise at less than normal value during the period of review (``POR'') March 5, 2009, through August 31, 2010.\2\
Silicic Acid, Sodium Salt etc.; Tolerance Exemption
Document Number: 2012-8733
Type: Rule
Date: 2012-04-11
Agency: Environmental Protection Agency
This regulation establishes an exemption from the requirement of a tolerance for residues of Silicic acid, sodium salt, reaction products with chlorotrimethylsilane and iso-propyl alcohol, reaction with poly(oxypropylene)-poly(oxyethylene) glycol; when used as an inert ingredient in a pesticide chemical formulation. Dow Corning Corporation submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of Silicic acid, sodium salt, reaction products with chlorotrimethylsilane and iso-propyl alcohol, reaction with poly(oxypropylene)-poly(oxyethylene) glycol on food or feed commodities.
Glycine From the People's Republic of China: Preliminary Results of Antidumping Duty Administrative Review and Partial Rescission of Antidumping Duty Administrative Review
Document Number: 2012-8732
Type: Notice
Date: 2012-04-11
Agency: Department of Commerce, International Trade Administration
In response to timely requests, the Department of Commerce is conducting an administrative review of the antidumping duty order on glycine from the People's Republic of China (PRC). The period of review is March 1, 2010, through February 28, 2011. We have preliminarily determined that Baoding Mantong Fine Chemistry Co., Ltd. (Baoding Mantong), made sales of subject merchandise at or above normal value during the period of review and invite interested parties to comment on these preliminary results. In addition, we are rescinding this administrative review with respect to 29 other companies.
Access to Confidential Business Information by CGI Federal Inc.
Document Number: 2012-8731
Type: Notice
Date: 2012-04-11
Agency: Environmental Protection Agency
EPA has authorized its contractor, CGI Federal Inc. (CGI) of Fairfax, VA, to access information which has been submitted to EPA under all sections of the Toxic Substances Control Act (TSCA). Some of the information may be claimed or determined to be Confidential Business Information (CBI).
Shrimp Fisheries of the Gulf of Mexico and South Atlantic; Revisions of Bycatch Reduction Device Testing Protocols
Document Number: 2012-8730
Type: Rule
Date: 2012-04-11
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
In accordance with the framework procedures for adjusting management measures of the Fishery Management Plan for the Shrimp Fishery of the Gulf of Mexico (Gulf FMP) and the Fishery Management Plan for the Shrimp Fishery of the South Atlantic Region (South Atlantic FMP), this rule certifies two new bycatch reduction devices (BRDs) for use in the Gulf of Mexico (Gulf) and South Atlantic shrimp fisheries, and revises a harvesting restriction for shrimp vessels fishing in Federal waters of the Gulf. Both BRDs represent modifications to the Composite Panel BRD, which is provisionally certified through May 24, 2012. This rule incorporates these BRDs into the list of allowable BRDs, and provides technical specifications for the construction and subsequent legal enforcement of these BRDs. Additionally, this rule reduces the shrimp effort threshold for the Gulf shrimp fishery. The intended effect of this final rule is to improve bycatch reduction efforts in the Gulf and South Atlantic shrimp fisheries, provide greater flexibility to the industry, reduce the potential adverse social and economic impacts to fishing communities of previous restrictions, and meet the requirements of National Standard 9 of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) which requires, to the extent practicable, the minimization of bycatch and bycatch mortality.
Approval and Promulgation of Air Quality Implementation Plan for 1997 8-Hour Ozone Standard; Arizona
Document Number: 2012-8729
Type: Proposed Rule
Date: 2012-04-11
Agency: Environmental Protection Agency
EPA is proposing to approve revisions to the Arizona state implementation plan (SIP) that demonstrate attainment of the 1997 8- hour ozone national ambient air quality standards in the Phoenix-Mesa nonattainment area by June 15, 2009. These SIP revisions are the 2007 Ozone Plan developed by the Maricopa Association of Governments and adopted and submitted to EPA by the Arizona Department of Environmental Quality on June 13, 2007. EPA is proposing to approve the 2007 Ozone Plan based on our determination that the plan contains all the provisions required for areas classified as nonattainment under Part D, Subpart 1 of the Clean Air Act, including the demonstration of reasonably available control measures (RACM), reasonable further progress (RFP), emission inventories, transportation conformity motor vehicle emission budgets for 2008, and contingency measures to be implemented if the Phoenix-Mesa nonattainment area fails to attain by June 15, 2009.
Notice of Proposed Administrative Cashout Agreement Pursuant to the Comprehensive Environmental Response, Compensation, and Liability Act; RE: Hassan Barrel Company
Document Number: 2012-8728
Type: Notice
Date: 2012-04-11
Agency: Environmental Protection Agency
Notice is hereby given of a proposed administrative settlement, subject to review and comment by the public pursuant to this Notice, under CERCLA concerning the Hassan Barrel Superfund Site (``Site'') in Fort Wayne, Allen County, Indiana. The settlement resolves a United States Environmental Protection Agency (EPA) claim under Sections 106, 107(a), and 122 of CERCLA, against two parties who have executed binding certifications of their consent to the settlement, as listed below in the Supplemental Information Section. The settlement requires the settling party to pay a total of $25,000 to the EPA Hazardous Substances Superfund. The settlement includes a covenant not to sue the settling party pursuant to Section 107(a) of CERCLA, 42 U.S.C. 9607(a). For thirty (30) days following the date of publication of this notice, the Agency will receive written comments relating to the settlement. The Agency will consider all comments received and may modify or withdraw its consent to the settlement if comments received disclose facts or considerations which indicate that the settlement is inappropriate, improper, or inadequate. The Agency's response to any comments received will be available for public inspection at the EPA, Region 5, 7th Floor File Room, 77 West Jackson Boulevard Chicago, Illinois.
Certain Kitchen Appliance Shelving and Racks From the People's Republic of China: Final Results of the Countervailing Duty Administrative Review
Document Number: 2012-8727
Type: Notice
Date: 2012-04-11
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (``the Department'') has completed its administrative review of the countervailable duty order on certain kitchen appliance shelving and racks (``Kitchen Racks'') from the People's Republic of China (``PRC'') for the period January 7, 2009, through December 31, 2009.\1\ On October 7, 2011, we published the preliminary results of this review.\2\ We provided interested parties with an opportunity to comment on the Preliminary Results. Our analysis of the comments submitted as well as incorporation of our post- preliminary analyses led to a change in the net subsidy rates. This review covers multiple exporters/producers, two of which are being individually reviewed as mandatory respondents. We find that the mandatory respondents, Guangdong Wireking Housewares & Hardware Co., Ltd. (``Wireking'') and New King Shan (Zhu Hai) Co., Ltd. (``NKS''), received countervailable subsidies during the POR. Their countervailing duty (``CVD'') rates have been used to calculate the rate applied to other firms subject to this review, as listed below in the section entitled ``Final Results of Review.''
National Institute on Aging; Notice of Closed Meeting
Document Number: 2012-8723
Type: Notice
Date: 2012-04-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2012-8722
Type: Notice
Date: 2012-04-11
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2012-8721
Type: Notice
Date: 2012-04-11
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2012-8720
Type: Notice
Date: 2012-04-11
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute: Notice of Closed Meeting
Document Number: 2012-8719
Type: Notice
Date: 2012-04-11
Agency: Department of Health and Human Services, National Institutes of Health
Notification of Two Public Teleconferences of the Science Advisory Board Biogenic Carbon Emissions Panel
Document Number: 2012-8716
Type: Notice
Date: 2012-04-11
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA or Agency) Science Advisory Board (SAB) Staff Office announces two public teleconferences of the SAB Biogenic Carbon Emissions Panel to discuss the Panel's draft report on EPA's draft Accounting Framework for Biogenic CO2 Emissions from Stationary Sources (September 2011).
Submission for OMB Review; Comment Request
Document Number: 2012-8715
Type: Notice
Date: 2012-04-11
Agency: Securities and Exchange Commission, Agencies and Commissions
Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Cod by Catcher/processors Using Trawl Gear in the Central Regulatory Area of the Gulf of Alaska
Document Number: 2012-8710
Type: Rule
Date: 2012-04-11
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS is prohibiting directed fishing for Pacific cod by catcher/processors (C/Ps) using trawl gear in the Central Regulatory Area of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the A season allowance of the 2012 Pacific cod total allowable catch apportioned to C/Ps using trawl gear in the Central Regulatory Area of the GOA.
Endangered Species; File No. 16645
Document Number: 2012-8707
Type: Notice
Date: 2012-04-11
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
Notice is hereby given that the Georgia Department of Natural Resources (GA DNR) has applied in due form for a permit pursuant to the Endangered Species Act of 1973, as amended (ESA). The permit application is for the incidental take of ESA-listed shortnose (Acipenser brevirostrum) and Atlantic sturgeon (A. oxyrinchus) associated with the otherwise lawful commercial shad fishery in Georgia. The duration of the proposed permit is 10 years. NMFS is furnishing this notice in order to allow other agencies and the public an opportunity to review and comment on the application materials. All comments received will become part of the public record and will be available for review.
Approval and Promulgation of Implementation Plans; Idaho: Infrastructure Requirements for the 1997 8-Hour Ozone National Ambient Air Quality Standard; Prevention of Significant Deterioration Greenhouse Gas Permitting Authority and Tailoring Rule
Document Number: 2012-8706
Type: Proposed Rule
Date: 2012-04-11
Agency: Environmental Protection Agency
EPA is proposing to approve the State Implementation Plan (SIP) submittals from the State of Idaho demonstrating that the Idaho SIP meets the requirements of section 110(a)(1) and (2) of the Clean Air Act (CAA) for the National Ambient Air Quality Standard (NAAQS) promulgated for ozone on July 18, 1997. EPA is proposing to find that the current Idaho SIP meets the following 110(a)(2) infrastructure elements for the 1997 8-hour ozone NAAQS: (A), (B), (C), (D)(ii), (E)(i), (E)(iii), (F), (G), (H), (J), (K), (L), and (M). EPA is taking no action on CAA section 110(a)(2)(E)(ii) at this time. We will address the requirements of this sub-element in a separate action. EPA is also proposing to approve a SIP revision that applies Idaho's Prevention of Significant Deterioration (PSD) Program to greenhouse gas (GHG) emitting sources above certain thresholds, updates Idaho's SIP to incorporate by reference revised versions of specific federal regulations, and removes unnecessary language from the SIP due to the incorporation by reference of the federal NAAQS and PSD regulations. In addition, EPA is proposing to rescind the Federal Implementation Plan (FIP) put in place to ensure the availability of a permitting authority for greenhouse gas emitting sources in Idaho.
Guidance on Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography Drugs; Availability
Document Number: 2012-8702
Type: Notice
Date: 2012-04-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs.'' This guidance is intended to help manufacturers of PET drugs meet the requirements for the Agency's current good manufacturing practice regulations for PET drugs.
Science Board to the Food and Drug Administration; Notice of Meeting
Document Number: 2012-8701
Type: Notice
Date: 2012-04-11
Agency: Food and Drug Administration, Department of Health and Human Services
Center for Scientific Review Notice of Closed Meetings
Document Number: 2012-8700
Type: Notice
Date: 2012-04-11
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; Experimental Study on Consumer Responses to Labeling Statements on Food Packages
Document Number: 2012-8699
Type: Notice
Date: 2012-04-11
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).
National Institute of Environmental Health Sciences Notice of Meeting
Document Number: 2012-8698
Type: Notice
Date: 2012-04-11
Agency: Department of Health and Human Services, National Institutes of Health
International Conference on Harmonisation; Draft Guidance for Industry on E2C(R2) Periodic Benefit-Risk Evaluation Report; Availability
Document Number: 2012-8697
Type: Notice
Date: 2012-04-11
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 ``E2C(R2) Periodic Benefit-Risk Evaluation Report.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance updates and combines two ICH guidances, ``E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (E2C guidance) and ``Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (addendum to the E2C guidance). The draft guidance describes the format, content, and timing of a periodic benefit-risk evaluation report (PBRER) for an approved drug or biologic. The harmonized PBRER is intended to promote a consistent approach to periodic postmarket safety reporting among the ICH regions and to enhance efficiency by reducing the number of reports generated for submission to the regulatory authorities.
National Institute Of Allergy And Infectious Diseases; Notice of Closed Meeting
Document Number: 2012-8696
Type: Notice
Date: 2012-04-11
Agency: Department of Health and Human Services, National Institutes of Health
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