July 14, 2009 – Federal Register Recent Federal Regulation Documents
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Notice of Availability: Notice of Funding Availability (NOFA) for HUD's Fiscal Year (FY) 2009 HOPE VI Revitalization Grants Program
HUD announces the availability on its Web site of the applicant information, submission deadlines, funding criteria and other requirements for HUD's HOPE VI Revitalization Program NOFA for FY 2009. Approximately $113 million is made available through this NOFA, to remain available until September 30, 2010, by the Department of Housing and Urban Development Appropriations Act, 2009 (Pub. L. 111-8, approved March 11, 2009) for HUD's HOPE VI Revitalization Program. The notice providing information regarding the application process, funding criteria and eligibility requirements is available on the Grants.gov Web site at https://apply07.grants.gov/apply/forms_apps_idx.html. A link to Grants.gov is also available on the HUD Web site at https:// www.hud.gov/offices/adm/grants/fundsavail.cfm. The Catalogue of Federal Domestic Assistance (CFDA) number for the HOPE VI Revitalization Program is 14.866. Applications must be submitted electronically through Grants.gov.
Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application.'' This document provides guidance to industry on postmarketing serious adverse event reporting for nonprescription (over-the-counter (OTC)) human drugs marketed without an approved application. It gives guidance on the minimum data elements that should be included in a serious adverse event report, the label that should be included with the report, reporting formats for paper and electronic submissions, and how and where to submit the reports. Separate guidance, issued by FDA's Center for Food Safety and Applied Nutrition on adverse event reporting for dietary supplements, is announced elsewhere in this issue of the Federal Register.
Notice of Availability: Notice of Funding Availability (NOFA) for Fiscal Year (FY) 2009 Doctoral Dissertation Research Grant Program
HUD announces the availability on its Web site of the application information, submission deadlines, funding criteria, and other requirements for the FY2009 Doctoral Dissertation Research Grant NOFA for FY(2009). Approximately $200,000 is made available through this NOFA, by the Department of Housing and Urban Development Appropriations Act, 2009 (Pub. L. 111-8, approved March 11, 2009), to enable doctoral candidates enrolled at institutions of higher education accredited by a national or regional accrediting agency recognized by the U.S. Department of Education to complete their dissertations on policy-relevant housing and urban development issues. The notice providing information regarding the application process, funding criteria and eligibility requirements is available on the Grants.gov Web site at https://apply07.grants.gov/apply/forms_apps_idx.html. A link to Grants.gov is also available on the HUD Web site at https:// www.hud.gov/offices/adm/grants/fundsavail.cfm. The Catalogue of Federal Domestic Assistance (CFDA) number for the Doctoral Dissertation Research Grant Program is 14.516. Applications must be submitted electronically through Grants.gov.
Notice of Availability: Notice of Funding Availability (NOFA) for Fiscal Year (FY) 2009 Hispanic-Serving Institutions Assisting Communities (HSIAC) Program
HUD announces the availability on its Web site of the application information, submission deadlines, funding criteria, and other requirements for the FY2009 Hispanic-Serving Institutions Assisting Communities (HSIAC) Program NOFA. Approximately $6 million is made available through this NOFA, by the Department of Housing and Urban Development Appropriations Act, 2009 (Pub. L. 111-8, approved March 11, 2009), to assist Hispanic-Serving Institutions (HSI) expand
Advisory Committee on Emerging Markets: Nominations
Notice is hereby given that nominations are being sought for twenty (20) qualified persons to serve on the Advisory Committee on Emerging Markets (the Committee). The role of the Committee is to provide information and advice, based upon knowledge and expertise of the members, useful to the Department of Agriculture (USDA) in implementing the Emerging Markets Program (EMP). The Committee also recommends ways to enhance agricultural exports through the involvement of the U.S. private sector in emerging markets and reviews qualified proposals submitted to the Program for funding technical assistance activities, from a business perspective.
Guidance for Institutional Review Boards, Frequently Asked Questions-Institutional Review Board Registration; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Guidance for Institutional Review Boards (IRBs), Frequently Asked Questions IRB Registration.'' This guidance is intended to assist IRBs in complying with the new requirement for IRB registration. This new rule requires each IRB in the United States that reviews FDA-regulated research to register using an Internet-based registration system that is maintained by the Department of Health and Human Services (HHS). This registration system is a modification of the one currently used by the Office for Human Research Protections (OHRP) for registration of IRBs that are designated by institutions under Federalwide Assurances (FWAs). OHRP has issued a similar rule requiring IRBs designated by institutions under FWAs to register or update their registration information using this modified system.
Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ``Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.'' The document provides guidance to the dietary supplement industry for complying with the serious adverse event reporting and recordkeeping requirements prescribed for dietary supplement manufacturers, packers, and distributors by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (the DSNDCPA). Separate guidance, issued by FDA's Center for Drug Evaluation and Research, on reporting for nonprescription (over-the-counter (OTC)) human drugs marketed without an approved application, is announced elsewhere in this issue of the Federal Register.
Dual Antiplatelet Therapy Trial: Research Project Grant (R01)
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of the Office of Critical Path Programs (OCPP). The goal of the Dual Antiplatelet Therapy (DAPT) Trial is to solicit a sole source grant application from Harvard Clinical Research Institute (HCRI) that proposes to provide funding in support of a dual antiplatelet therapy clinical trial being conducted by HCRI.
Submission for OMB Review; Comment Request
The Director, Information Collection Clearance Division, Regulatory Information Management Services, Office of Management invites comments on the submission for OMB review as required by the Paperwork Reduction Act of 1995.
Pick-Sloan Missouri Basin Program-Eastern Division-Rate Order No. WAPA-147
The Western Area Power Administration (Western) is proposing revised rates for Pick-Sloan Missouri Basin ProgramEastern Division (P-SMBPED) firm electric and firm peaking power service. Current rates, under Rate Schedules P-SED-F10 and P-SED-FP10, extend through December 31, 2013, but are not sufficient to meet the P-SMBPED revenue requirements. The proposed rates will provide sufficient revenue to pay all annual costs, including interest expense, and repay investments within the allowable periods. Western will prepare and make available a brochure that provides detailed information on the proposed rates. The proposed rates, under Rate Schedules P-SED-F11 and P-SED- FP11, would go into effect on January 1, 2010, and would remain in effect through December 31, 2014, or until superseded. Publication of this Federal Register notice begins the formal process for the proposed rate adjustment.
Loveland Area Projects-Rate Order No. WAPA-146
The Western Area Power Administration (Western) is proposing revised rates for Loveland Area Projects (LAP) firm electric service. LAP consists of the Fryingpan-Arkansas Project (Fry-Ark) and the Pick- Sloan Missouri Basin ProgramWestern Division (Pick-SloanWD), which were integrated for marketing and rate-making purposes in 1989. Current rates, under Rate Schedule L-F8, extend through December 31, 2013, but are not sufficient to meet LAP revenue requirements. The proposed rates will provide sufficient revenue to pay all annual costs, including interest expense, and repay investments within the allowable periods. Western will prepare and make available a brochure that provides detailed information on the proposed rates. The proposed rates, under Rate Schedule L-F9, would go into effect on January 1, 2010, and would remain in effect through December 31, 2014, or until superseded. Publication of this Federal Register notice begins the formal process for the proposed rate adjustment.
Information Collection Request to Office of Management and Budget; OMB Control Numbers: 1625-0080
In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit an Information Collection Request (ICR) and Analysis to the Office of Management and Budget (OMB) requesting an extension of its approval for the following collection of information: 1625-0080, Customer Satisfaction Surveys. Before submitting this ICR to OMB, the Coast Guard is inviting comments as described below.
Safety Zones: Annual Events Requiring Safety Zones in the Captain of the Port Buffalo Zone
The Coast Guard will enforce certain safety zones for annual fireworks displays in the Captain of the Port Buffalo Zone. This action is necessary for the safety of life and property on navigable waters during these events. During the enforcement period, no person or vessel may enter the safety zones without the permission of the Captain of the Port Buffalo.
Privacy Act Implementation
The Federal Housing Finance Agency (FHFA) is issuing a final regulation to provide the procedures and guidelines under which it will implement the Privacy Act of 1974, as amended. The regulation provides the policies and procedures whereby individuals may obtain notification of whether an FHFA system of records contains information about the individual and, if so, how to access or amend a record under the Privacy Act. Upon adoption of this regulation the Privacy Act regulations of the Federal Housing Finance Board and the Office of Federal Housing Enterprise Oversight, will be removed.
Marine Mammals; File No. 775-1875
Notice is hereby given that NMFS Northeast Fisheries Science Center (NEFSC), Woods Hole, MA, has been issued a major amendment to Permit No. 775-1875 for research on marine mammals.
Submission for OMB Review; Comment Request
The Director, Information Collection Clearance Division, Regulatory Information Management Services, Office of Management invites comments on the submission for OMB review as required by the Paperwork Reduction Act of 1995.
Magnuson-Stevens Fishery Conservation and Management Act Provisions; Fisheries of the Northeastern United States; Atlantic Mackerel, Squid, and Butterfish Fisheries; Amendment 10
NMFS announces that the Mid-Atlantic Fishery Management Council (Council) has submitted Amendment 10 to the Atlantic Mackerel, Squid, and Butterfish (MSB) Fishery Management Plan (FMP) (Amendment 10), incorporating the public hearing document and the Initial Regulatory Flexibility Analysis (IRFA), for review by the Secretary of Commerce and is requesting comments from the public.
Submission for OMB Review; Comment Request
The Director, Information Collection Clearance Division, Regulatory Information Management Services, Office of Management invites comments on the submission for OMB review as required by the Paperwork Reduction Act of 1995.
Submission for OMB Review; Comment Request
The Director, Information Collection Clearance Division, Regulatory Information Management Services, Office of Management invites comments on the submission for OMB review as required by the Paperwork Reduction Act of 1995.
Electronic Registration for Deposit Account Holders
The Copyright Office is proposing to amend its regulations to require that applications for registration paid for by deposit account debits be submitted electronically using the electronic Copyright Office (eCO) registration system (eService). The Copyright Office is also requesting comment as to whether deposit accounts offer sufficient efficiencies to continue offering this service.
Submission for OMB Review; Comment Request
The Director, Information Collection Clearance Division, Regulatory Information Management Services, Office of Management invites comments on the submission for OMB review as required by the Paperwork Reduction Act of 1995.
General Management Plan/Wilderness Study/Off-Road Vehicle Management Plan, Draft Environmental Impact Statement, Big Cypress National Preserve Addition, Florida
Pursuant to 42 U.S.C. 4332(2)(C) of the National Environmental Policy Act of 1969 and National Park Service (NPS) policy in Director's Order Number 2 (Park Planning) and Director's Order Number 12 (Conservation Planning, Environmental Impact Analysis, and Decision- making), the NPS announces the availability of a DEIS/GMP/WS/ORV Plan for the Big Cypress National Preserve Addition, Florida.
Medical Use of Byproduct Material-Authorized User Clarification
The U.S. Nuclear Regulatory Commission (NRC) is amending its regulations to clarify that individuals who do not need to comply with the training and experience requirements as described in the applicable regulations for the medical use of byproduct material (i.e., are ``grandfathered'') may serve as preceptors and work experience supervisors for individuals seeking recognition on NRC licenses for the same medical uses of byproduct material. The regulations that govern the medical use of byproduct material were amended in their entirety in 2002 and again in 2005. Currently, individuals who were identified on an NRC or Agreement State license or permit before the regulations were amended do not need to requalify by meeting the training and experience (T&E) requirements of the applicable regulations. When the regulations were revised, the NRC intended that those authorized individuals would also be able to serve as preceptors and work experience supervisors. However, the regulations as they are currently written do not specifically state that grandfathered individuals can be work experience supervisors and preceptors.
Medical Use of Byproduct Material-Authorized User Clarification
The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its regulations to clarify that individuals who do not need to comply with the training and experience requirements as described in the applicable regulations for the medical use of byproduct material ( i.e., are ``grandfathered'') may serve as preceptors and work experience supervisors for individuals seeking recognition on NRC licenses for the same medical uses of byproduct material. The regulations that govern the medical use of byproduct material were amended in their entirety in 2002 and again in 2005. Currently, individuals who were identified on an NRC or Agreement State license or permit before the regulations were amended do not need to requalify by meeting the training and experience requirements of the applicable regulations. When the regulations were revised, the NRC intended that those authorized individuals would also be able to serve as preceptors and work experience supervisors. However, the regulations as they are currently written do not specifically state that grandfathered individuals can be work experience supervisors and preceptors.
Stainless Steel Bar From Brazil: Final Results of Antidumping Duty Administrative Review
On March 9, 2009, the Department of Commerce (the Department) published the preliminary results of the administrative review of the antidumping duty order on certain stainless steel bar from Brazil. The period of review (POR) is February 1, 2007, through January 31, 2008. We gave interested parties an opportunity to comment on the preliminary results. Based on our analysis of the comments received and an examination of our calculations, we have made changes for the final results. The final weighted-average dumping margin is listed below in the ``Final Results of the Review'' section of this notice.
Fiscal Year 2010-2015 Information Security Strategic Plan; Solicitation of Public Comment
The Nuclear Regulatory Commission (NRC) is soliciting public comment on its draft information security strategic plan (ISSP) for Fiscal Year 2010-2015 (ADAMS Accession No. ML090230026). The purpose of the NRC's ISSP is to establish an information security (IS) vision and to focus the NRC's IS program on attaining that vision.
Notice of Stay of Filing of Plat
On Wednesday, January 14, 2009, the Bureau of Land Management (BLM) published a Filing of Plats of Survey notice in the Federal Register (74 FR 2090). This notice provided the public notification that the plat was officially filed in the Colorado State Office, effective 10 a.m., December 31, 2008. The BLM is publishing this notice to inform the public of the setting aside of the plat filing and to afford all affected parties a proper period of time to protest this action, prior to the plat filing.
Certain Circular Welded Non-Alloy Steel Pipe and Tube from Mexico; Extension of Time Limit for Final Results of Antidumping Duty Changed Circumstances Review
The Department of Commerce (the Department) finds that it is not practicable to complete the final results of this changed circumstances review within the original time frame as it would be impossible to consider the parties comments and to complete the final results of this changed circumstances review within the original time frame. Accordingly, the Department is extending the time limit for completion of the final results of this changed circumstances review by 31 days to August 17, 2009.
Naches Ranger District, Okanogan-Wenatchee National Forest; Minor Pacific Crest National Scenic Trail Relocation
A minor relocation (approximately 2,000 feet) will occur on the Pacific Crest National Scenic Trail (PCNST) in 2009. The trail will be re-routed from its current location within the White Pass Ski Area south to the Wilderness boundary on the edge of the expansion area with the purpose of maintaining a quality, uninterrupted backcountry experience for PCNST users and to minimize their views of ski area structures and facilities. All activities were analyzed in the White Pass Expansion Master Development Plan Proposal Final Environmental Impact Statement and documented in the June 2007 Record of Decision. Relocation will begin in July 2009 and is expected to be completed by fall 2009. Trail relocation will be done in conjunction with the Pacific Crest Trail Association.
Affirmative Preliminary Determination of Circumvention of the Antidumping Duty Order on Certain Cut-to-Length Carbon Steel Plate from the People's Republic of China
We preliminarily determine that imports from the People's Republic of China (PRC) of cut-to-length carbon steel plate products with 0.0008 percent or more boron, by weight, produced by Tianjin, regardless of the exporter or the importer of the merchandise, and otherwise meeting the description of in-scope merchandise, are within the class or kind of merchandise subject to the order on certain cut- to-length carbon steel plate from the PRC. We also preliminarily determine that imports from the PRC of cut-to-length carbon steel plate products with 0.0008 percent or more boron, by weight, imported by Toyota Tsusho, regardless of the producer or exporter of the merchandise, and otherwise meeting the description of in-scope merchandise, are within the class or kind of merchandise subject to the order on certain cut-to-length carbon steel plate from the PRC.
Delta-Mendota Canal/California Aqueduct Intertie, Alameda County, CA
The Bureau of Reclamation, as the National Environmental Policy Act Federal lead agency, has made available for public review and comment the Delta-Mendota Canal/California Aqueduct Intertie (Intertie) Draft EIS. The Intertie is a proposed action in the August 2000 CALFED Bay-Delta Program Programmatic Record of Decision. The Intertie Draft EIS evaluates constructing and operating a pipeline connecting the Delta-Mendota Canal (DMC) and the California Aqueduct. The purpose of the Proposed Action is to improve the DMC conveyance conditions that restrict the CVP Jones Pumping Plant to less than its authorized pumping capacity of 4,600 cubic feet per second. The Draft EIS describes and presents the environmental effects of the No-Action Alternative and three action alternatives. Two public hearings will be held to receive comments from agencies, individuals, and organizations on the Draft EIS.
Revisions to the California State Implementation Plan, San Joaquin Valley Air Pollution Control District
EPA is proposing a limited approval and limited disapproval of revisions to the San Joaquin Valley Air Pollution Control District (SJVAPCD) portion of the California State Implementation Plan (SIP). These revisions concern volatile organic compound (VOC) emissions from confined animal facilities (CAFs) such as dairies, cattle feedlots, poultry and swine farms. We are proposing action on a local rule that regulates these emission sources under the Clean Air Act as amended in 1990 (CAA or the Act). We are taking comments on this proposal and plan to follow with a final action.
Fisheries of the Exclusive Economic Zone Off Alaska; Northern Rockfish in the Western Regulatory Area of the Gulf of Alaska
NMFS is prohibiting directed fishing for northern rockfish in the Western Regulatory Area of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the 2009 total allowable catch (TAC) of northern rockfish in the Western Regulatory Area of the GOA.
Revisions to the California State Implementation Plan, San Joaquin Valley Unified Air Pollution Control District
EPA is proposing a limited approval and limited disapproval of revisions to the San Joaquin Valley Unified Air Pollution Control District portion of the California State Implementation Plan. These revisions concern a local fee rule that applies to major sources of volatile organic compound and nitrogen oxide emissions within the San Joaquin Valley ozone nonattainment area. We are approving a local rule that regulates these emission sources under the Clean Air Act as amended in 1990. We are taking comments on this proposal and plan to follow with a final action.
Partially Closed Meeting of the Information Security and Privacy Advisory Board
The Director of the National Institute of Standards and Technology announces that the Information Security and Privacy Advisory Board will meet Wednesday, July 29, 2009 from 8:30 a.m.. until 5 p.m., Thursday, July 30, 2009, from 8:30 a.m. until 5 p.m., and Friday, July 31, 2009 from 8 a.m. until 4 p.m. The portion of the meeting held from 1 p.m. until 4 p.m. on Friday July 31, 2009 will be closed to the public.
Notice of Public Meeting and Solicitation of Written Comments
The Department of State and the Office of the United States Trade Representative (USTR), co-leads of the U.S. bilateral investment treaty (BIT) program, are soliciting written comments and will hold a public meeting concerning the Administration's review of the U.S. model BIT. The review is intended to ensure that the model BIT is consistent with the public interest and the overall U.S. economic agenda. The key question is whether the current model text, last updated in 2004, achieves these objectives or whether there are changes that should be made.
Environmental Management Site-Specific Advisory Board, Portsmouth
This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Portsmouth. The Federal Advisory Committee Act (Pub. L. No. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the Federal Register.
Notice of Intent To Seek Approval To Conduct an Information Collection
In accordance with the Paperwork Reduction Act of 1995, this notice announces the intention of the National Agricultural Statistics Service (NASS) to seek reinstatement of an information collection, the Census of Horticultural Specialties.
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