2011 – Federal Register Recent Federal Regulation Documents
Results 8,051 - 8,100 of 33,060
Maine; Amendment No. 1 to Notice of a Major Disaster Declaration
This notice amends the notice of a major disaster declaration for the State of Maine (FEMA-4032-DR), dated September 13, 2011, and related determinations.
Missouri; Amendment No. 3 to Notice of a Major Disaster Declaration
This notice amends the notice of a major disaster declaration for the State of Missouri (FEMA-4012-DR), dated August 12, 2011, and related determinations.
New York; Amendment No. 3 to Notice of a Major Disaster Declaration
This notice amends the notice of a major disaster declaration for the State of New York (FEMA-4031-DR), dated September 13, 2011, and related determinations.
New York; Amendment No. 1 to Notice of an Emergency Declaration
This notice amends the notice of an emergency declaration for the State of New York (FEMA-3341-EM), dated September 8, 2011, and related determinations.
Environmental Justice; Proposed Circular
The Federal Transit Administration (FTA) has placed in the docket and on its Web site, proposed guidance in the form of a Circular on incorporating environmental justice principles into plans, projects, and activities that receive funding from FTA. This proposed guidance provides recommendations to State Departments of Transportation, Metropolitan Planning Organizations, public transportation providers, and other recipients of FTA funds on how to fully engage environmental justice populations in the public transportation decisionmaking process; how to determine whether environmental justice populations would be subjected to disproportionately high and adverse human health or environmental effects as a result of a transportation plan, project, or activity; and how to avoid, minimize, or mitigate these effects. By this notice, FTA invites public comment on this proposed Circular.
Title VI; Proposed Circular
The Federal Transit Administration (FTA) has placed in the docket and on its Web site, proposed guidance in the form of a Circular to assist grantees in complying with Title VI of the Civil Rights Act of 1964. The purpose of this Circular is to provide recipients of FTA financial assistance with instructions and guidance necessary to carry out the U.S. Department of Transportation's Title VI regulations (49 CFR part 21). FTA is updating its Title VI Circular to clarify requirements for compliance. By this notice, FTA invites public comment on the proposed Circular.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Miner's Claim for Benefits Under the Black Lung Benefits Act and Employment History
The Department of Labor (DOL) is submitting the Office of Workers' Compensation Programs (OWCP) sponsored information collection request (ICR) titled, ``Miner's Claim for Benefits Under the Black Lung Benefits Act and Employment History,'' to the Office of Management and Budget (OMB) for review and approval for continued use in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501 et seq.).
Request for Notification From Industry Organizations Interested in Participating in the Selection Process and Request for Nominations for a Nonvoting Industry Representative on the Vaccines and Biological Products Advisory Committee
The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Vaccines and Related Biological Products Advisory Committee for the Center for Biologics Evaluation and Research (CBER) notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative to serve the Vaccines and Related Biological Products Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nomination will be accepted for current vacancies effective with this notice.
Notice of Quarterly Report (April 1, 2011-June 30, 2011)
The Millennium Challenge Corporation (MCC) is reporting for the quarter April 1, 2011 through June 30, 2011, on assistance provided under section 605 of the Millennium Challenge Act of 2003 (22 U.S.C. 7701 et seq.), as amended (the Act), and on transfers or allocations of funds to other Federal agencies under section 619(b) of the Act. The following report will be made available to the public by publication in the Federal Register and on the Internet Web site of the MCC (https:// www.mcc.gov) in accordance with section 612(b) of the Act.
Guidance for Industry on Time and Extent Applications for Nonprescription Drug Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Time and Extent Applications for Nonprescription Drug Products.'' This guidance describes a two-step process on how to request that a new condition be added to the over-the-counter (OTC) drug monograph system. The process includes submitting a time and extent application (TEA) to determine whether a condition is eligible for inclusion in the OTC drug monograph system and, if the condition is found to be eligible, submitting safety and effectiveness data. This guidance is designed to clarify the TEA process and what happens after a TEA is submitted. This guidance finalizes the draft guidance for industry entitled ``Time and Extent Applications'' published in the Federal Register on February 10, 2004 (69 FR 6309).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Marketing Act of 1987; Administrative Procedures, Policies, and Requirements
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).
Center for Drug Evaluation and Research, Approach to Addressing Drug Shortage; Public Workshop; Request for Comments
The Food and Drug Administration (FDA) is opening a comment period for the notice of public workshop published in the Federal Register of July 28, 2011 (76 FR 45268). In that notice, FDA announced a public workshop regarding the approach of the Center for Drug Evaluation and Research to addressing drug shortages. FDA is opening a comment period in light of public interest in this topic and in order to gain additional insight about the causes and impact of drug shortages, and possible strategies for preventing or mitigating drug shortages.
Guidance for Industry on Target Animal Safety and Effectiveness Protocol Development and Submission; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (215) entitled ``Target Animal Safety and Effectiveness Protocol Development and Submission.'' The purpose of this document is to provide sponsors guidance in preparation of study protocols for review by the Center for Veterinary Medicine, Office of New Animal Drug Evaluation. The recommendations included in this guidance are intended to reduce the time to protocol concurrence.
Notice of Public Meeting
The U.S. Department of State, Bureau of Oceans and International Environmental and Scientific Affairs (OES), Office of Marine Conservation announces that the Advisory Panel to the U.S. Section of the North Pacific Anadromous Fish Commission will meet on October 6, 2011. Dates: The meeting will take place via teleconference on October 6th, 2011, from 2 p.m. to 4 p.m. Eastern time. Meeting Details: The teleconference call-in number is toll-free 1- 888-989-7597, passcode 21898, and will have a limited number of lines for members of the public to access from anywhere in the United States. Callers will hear instructions for using the passcode and joining the call after dialing the toll-free number noted. Members of the public wishing to participate in the teleconference must contact the OES officer in charge as noted in the FOR FURTHER INFORMATION CONTACT section below no later than close of business on Tuesday, October 4th, 2011. For Further Information Contact: John Field, Office of Marine Conservation, OES, Room 2758, U.S. Department of State, 2201 C Street, NW., Washington, DC 20520. Telephone (202) 647-3263, fax (202) 736- 7350, e-mail fieldjd@state.gov. Supplementary Information: In accordance with the requirements of the Federal Advisory Committee Act, notice is given that the Advisory Panel to the U.S. Section of the North Pacific Anadromous Fish Commission (NPAFC) will meet on the date and time noted above. The panel consists of members from the states of Alaska and Washington who represent the broad range fishing and conservation interests in anadromous and ecologically related species in the North Pacific. Certain members also represent relevant state and regional authorities. The panel was established in 1992 to advise the U.S. Section of the NPAFC on research needs and priorities for anadromous species, such as salmon, and ecologically related species occurring in the high seas of the North Pacific Ocean. The upcoming Panel meeting will focus on two major topics: (1) Review of the agenda for the 2011 annual meeting of the NPAFC (October 24-28; Nanaimo, British Columbia, Canada); and (2) logistics for the U.S. Section at the NPAFC meeting. Background material is available from the point of contact noted above and by visiting https://www.npafc.org. This announcement will appear in the Federal Register less than 15 days prior to the meeting. The Department of State finds that there is an exceptional circumstance in that this advisory committee meeting must be held on October 6th in order to adequately prepare for the NPAFC to be convened in Canada beginning October 24th, including the logistics involved in attending the meeting.
Reports, Forms and Recordkeeping Requirements Agency Information Collection Activity Under OMB Review
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), this notice announces that the Information Collection Request (ICR) abstracted below has been forwarded to the Office of Management and Budget (OMB) for review and comment. The ICR describes the nature of the information collections and their expected burden. The Federal Register Notice with a 60-day comment period was published on June 24, 2011 [76 FR 37189].
Proposed CERCLA Administrative Past Cost Recovery Settlement; IUNA, Inc. aka IU North America, Inc., Mine 2028 Site, Brazil, IN, SF Site #B5KK
In accordance with Section 122(i) of the Comprehensive Environmental Response, Compensation, and Liability Act, as amended (``CERCLA''), 42 U.S.C. 9622(i), notice is hereby given of a proposed administrative settlement for recovery of past response costs concerning the Mine 2028 site in Brazil, Clay County, Indiana with the following settling party: IUNA, Inc., also known as IU North America, Inc. The settlement requires the settling party to pay $100,000 to the Hazardous Substance 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 EPA will receive written comments relating to the settlement. The EPA 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 EPA's response to any comments received will be available for public inspection at EPA's Record Center, U.S. EPA, Room 714, 77 West Jackson Boulevard, Chicago, IL 60604.
Application for Annuity or Lump Sum
The Railroad Retirement Board (Board) amends its regulations to allow alternative signature methods in addition to the traditional pen-and-ink or ``wet'' signature in order to implement an electronic application process which will eventually eliminate the need to retain paper applications and make the application process more convenient for the individuals filing applications.
Exemption to Prohibition on Circumvention of Copyright Protection Systems for Access Control Technologies
The United States Copyright Office is preparing to conduct proceedings in accordance with provisions added by the Digital Millennium Copyright Act which provide that the Librarian of Congress, upon the recommendation of the Register of Copyrights, may exempt certain classes of works from the prohibition against circumvention of technological measures that control access to copyrighted works. The purpose of this rulemaking proceeding is to determine whether there are particular classes of works as to which users are, or are likely to be, adversely affected in their ability to make noninfringing uses due to the prohibition on circumvention. This notice requests written comments from all interested parties, including representatives of copyright owners, educational institutions, libraries and archives, scholars, researchers and members of the public, in order to elicit evidence on whether noninfringing uses of certain classes of works are, or are likely to be, adversely affected by this prohibition on the circumvention of measures that control access to copyrighted works.
National Institute of Justice Interview Room Recording Systems and License Plate Readers Workshop
The National Institute of Justice (NIJ) and the International Association of Chiefs of Police (IACP) are hosting two workshops in conjunction with the 118th Annual IACP Conference in Chicago, Ill. The focus of the workshops is the development of NIJ performance standards for Interview Room Recording Systems and License Plate Readers used by law enforcement agencies. Sessions are intended to inform manufacturers, test laboratories, certification bodies and other interested parties of these standards development efforts. Attendees in each workshop will be provided with an overview of the NIJ standards development process, work to date on the effort and a projected timeline for completion. Please access the following webpage to register for the Interview Room Video Systems workshop: https://www.surveymonkey.com/s/ interviewroomworkshopreg. Please access the following webpage to register for the License Plate Reader workshop: https://www.surveymonkey.com/s/ALPRworkshop reg.
Prospective Grant of Exclusive License: Compositions and Method for Preventing Reactogenicity Associated with Administration of Immunogenic Live Rotavirus Compositions
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Provisional Patent Application No. 60/178,689, filed January 28, 2000 [HHS Ref. No. E-088-2000/0-US-01], now expired; PCT Patent Application No. PCT/US01/02686 [HHS Ref. No. E-088-2000/0-PCT-02] filed January 26, 2001, which published as WO/2001/54718 on August 2, 2001, now expired; U.S. Patent No. 7,431,931 [HHS Ref. No. E-088-2000/0-US-06]; Australian Patent No. 784344 [HHS Ref. No. E-088-2000/0-AU-04]; German Patent No. 60141681.308 [HHS Ref. No. E-088-2000/0-DE-08]; French Patent No. 1251869 [HHS Ref. No. E-088-2000/0-FR-09]; United Kingdom Patent No. 1251869 [HHS Ref. No. E-088-2000/0-GB-10]; and Canadian Patent Application No. 2398428 [HHS Ref. No. E-088-2000/0-CA-05], entitled ``Compositions and Method for Preventing Reactogenicity Associated with Administration of Immunogenic Live Rotavirus Compositions,'' and all continuing applications to International Medica Foundation, having a place of business in Rochester, Minnesota. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be ``worldwide'', and the field of use may be limited to ``rhesus-based rotavirus therapeutic and/or prophylactic vaccines.''
Phytosanitary Treatments; Location of and Process for Updating Treatment Schedules; Technical Amendment
In a final rule that was published in the Federal Register on January 26, 2010, and effective on February 25, 2010, we amended the phytosanitary treatment regulations by removing the lists of approved treatments and treatment schedules from the regulations, while retaining the general requirements for performing treatments and certifying or approving treatment facilities. The final rule also removed treatment schedules from other places where they had been found in APHIS regulations and provided that approved treatment schedules will instead be found in the Plant Protection and Quarantine Treatment Manual, which is available on the Internet. In the final rule, we neglected to provide for the Administrator of the Animal and Plant Health Inspection Service to approve treatments that are not found in the Treatment Manual, and we did not retain text explaining that irradiation can be used as a substitute for other treatments. In this amendment, we are amending the regulation to provide for such approval of treatments and to restore the text we removed.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Representative Payee Report, Representative Payee Report, Short Form, Physician's/Medical Officer's Statement
The Department of Labor (DOL) is submitting the Office of Workers' Compensation Programs (OWCP) sponsored information collection request (ICR) titled, ``Representative Payee Report, Representative Payee Report, Short Form, Physician's/Medical Officer's Statement,'' to the Office of Management and Budget (OMB) for review and approval for continued use in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501 et seq.).
Irradiation Treatment; Location of Facilities in the Southern United States
We are proposing to amend the phytosanitary treatment regulations to provide generic criteria for new irradiation treatment facilities in the Southern States of the United States. This action would allow irradiation facilities to be located anywhere in these States, subject to approval, rather than only in the currently approved locations. We are also proposing to allow for the irradiation treatment of certain imported fruit from India and Thailand upon arrival in the United States. This action would facilitate the importation of fruit requiring irradiation treatment while continuing to provide protection against the introduction of pests of concern into the United States.
Florigene Pty., Ltd.; Determination of Nonregulated Status for Altered Color Roses
We are advising the public of our determination that two hybrid rose lines developed by Florigene Pty., Ltd., designated as IFD- 524[Oslash]1-4 and IFD-529[Oslash]1-9, which have been genetically engineered to produce novel flower color, are no longer considered a regulated article under our regulations governing the introduction of certain genetically engineered organisms. Our determination is based on our evaluation of data submitted by Florigene Pty., Ltd., in its petition for a determination of nonregulated status, our analysis of available scientific data, and comments received from the public in response to our previous notice announcing the availability of the petition for nonregulated status and its associated environmental assessment and plant pest risk assessment. This notice also announces the availability of our written determination and finding of no significant impact.
Gypsy Moth Generally Infested Areas; Additions in Indiana, Maine, Ohio, Virginia, West Virginia, and Wisconsin
We are adopting as a final rule, without change, an interim rule that amended the regulations to add areas in Indiana, Maine, Ohio, Virginia, West Virginia, and Wisconsin to the list of generally infested areas based on the detection of infestations of gypsy moth in those areas. The interim rule was necessary to prevent the artificial spread of the gypsy moth to noninfested areas of the United States.
Golden Nematode; Removal of Regulated Areas
We are amending the golden nematode regulations by removing the townships of Elba and Byron in Genesee County, NY, from the list of generally infested areas. Surveys have shown that the fields in these two townships are free of golden nematode, and we have determined that regulation of these areas is no longer necessary. As a result of this action, all the areas in Genesee County, NY, that have been listed as generally infested will be removed from the list of areas regulated for golden nematode.
Notice of Availability of a Pest Risk Analysis for the Importation of Fresh Tejocote Fruit From Mexico
We are advising the public that we have prepared a pest risk analysis that evaluates the risks associated with the importation into the continental United States of fresh tejocote fruit from Mexico. Based on this analysis, we believe that the application of one or more designated phytosanitary measures will be sufficient to mitigate the risks of introducing or disseminating plant pests or noxious weeds via the importation of fresh tejocote fruit from Mexico. We are making the pest risk analysis available to the public for review and comment.
Syngenta Biotechnology, Inc.; Determination of Nonregulated Status for Lepidopteran-Resistant Cotton
We are advising the public of our determination that a cotton line developed by Syngenta Biotechnology, Inc., designated as event COT67B, which has been genetically engineered to express a protein to protect cotton plants from lepidopteran insect damage, is no longer considered a regulated article under our regulations governing the introduction of certain genetically engineered organisms. Our determination is based on our evaluation of data submitted by Syngenta Biotechnology, Inc., in its petition for a determination of nonregulated status, our analysis of available scientific data, and comments received from the public in response to our previous notice announcing the availability of the petition for nonregulated status and its associated environmental assessment and plant pest risk assessment. This notice also announces the availability of our written determination and finding of no significant impact.
Notice of Availability of a Pest Risk Analysis for the Importation of Pomegranate From India Into the Continental United States
We are advising the public that we have prepared a pest risk analysis that evaluates the risks associated with the importation into the continental United States of fresh pomegranate fruit from India. Based on that analysis, we believe that the application of one or more designated phytosanitary measures will be sufficient to mitigate the risks of introducing or disseminating plant pests or noxious weeds via the importation of fresh pomegranate fruit from India. We are making the pest risk analysis available to the public for review and comment.
Endangered and Threatened Wildlife and Plants; 90-Day Finding on a Petition To List the American Eel as Threatened
We, the U.S. Fish and Wildlife Service (Service), announce a 90-day finding on a petition to list the American eel (Anguilla rostrata) as threatened under the Endangered Species Act of 1973, as amended (Act). Based on our review, we find that the petition presents substantial scientific or commercial information indicating that listing this species may be warranted. Therefore, with the publication of this notice, we are initiating a review of the status of the species to determine if listing the American eel is warranted. To ensure that this status review is comprehensive, we are requesting scientific and commercial data and other information regarding this species. Based on the status review, we will issue a 12-month finding on the petition, which will address whether the petitioned action is warranted, as provided in section 4(b)(3)(B) of the Act.
Settlement Agreements for Recovery of Past Response Costs; Granite Timber Post and Pole Site, Philipsburg, Granite County, MT
In accordance with the requirements of Section 122(i)(1) of the Comprehensive Environmental Response, Compensation, and Liability Act, as amended (CERCLA), 42 U.S.C. 9622(i)(1), notice is hereby given of two Settlement Agreements under Section 122 (h)(1) of CERCLA, 42 U.S.C. 9622 (h)(1), between the United States Environmental Protection Agency (EPA) and Margery Metesh (Settling Party) and Mark Metesh (Settling Party), regarding the Granite Timber Site (Site), located 5 miles south of Philipsburg and 0.5 miles west of Montana Highway 10A in Granite County, Montana. The Settlement Agreements propose to compromise a claim the United States has at this Site for Past Response Costs, as those terms are defined in the Settlement Agreements. Under the terms of the Settlement Agreements, the EPA and the Settling Parties agree that the Settling Parties have no ability to pay and the Settling Parties agree not to assert any claims or causes of action against the United States or its contractors or employees with respect to the Site. Additionally, Margery Metesh (Settling Party) agrees to file a deed record notice concerning a building on a small portion of the Site property. In exchange, the Settling Parties will be granted a covenant not to sue under section 107(a) of CERCLA, 42 U.S.C. 9607(a), with regard to reimbursement of Past Response Costs. Opportunity for Comment: For thirty (30) days following the publication of this notice, the EPA will consider all comments received and may modify or withdraw its consent to that portion of the Settlement Agreement, if comments received disclose facts or considerations which indicate that the settlement is inappropriate, improper, or inadequate. The EPA's response to any comments received will be available for public inspection at the Superfund Record Center, EPA Region 8, 1595 Wynkoop Street, 3rd Floor, in Denver, Colorado.
Comment Request for Information Collection; Apprenticeship Programs, Labor Standards for Registration; Extension With Revisions
The Department of Labor (Department), as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) [44 U.S.C. 3506(c)(2)(A)]. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Employment and Training Administration (ETA) is soliciting comments concerning the collection of data about Title 20 CFR part 29, Apprenticeship Programs, Labor Standards for Registration with an expiration date of January 31, 2012. A copy of the proposed information collection request (ICR) can be obtained by contacting the office listed below in the addresses section of this notice.
Adequacy Status of the Ohio Portion of the Huntington/Ashland Submitted Annual Fine Particulate Matter Maintenance Plan for Transportation Conformity Purposes
In this notice, EPA is notifying the public that we have made insignificance findings through the transportation conformity adequacy process, under the Clean Air Act, for directly emitted fine particulate matter (PM2.5) and oxides of nitrogen (NOX) in the Ohio portion of the Huntington/Ashland WV-KY-OH area. Ohio submitted the insignificance findings with the redesignation and maintenance plan submittal on May 4, 2011. As a result of our findings, the Ohio portion of the Huntington/Ashland area is no longer required to perform a regional emissions analysis for either directly emitted PM2.5 or NOX as part of future PM2.5 conformity determinations for the 1997 annual PM2.5 air quality standard.
DHS Data Privacy and Integrity Advisory Committee; Meeting
On Wednesday, September 21, 2011, the DHS Privacy Office announced in the Federal Register at 76 FR 58524 that the Data Privacy and Integrity Advisory Committee would meet on October 5, 2011, in Arlington, Virginia. This notice supplements that original meeting notice.
Revision of Cotton Futures Classification Procedures
The Agricultural Marketing Service (AMS) is proposing to update the procedures for cotton futures quality classification services by using Smith-Doxey classification data in the cotton futures classification process. In addition, references to a separate and optional review of cotton futures certification would be eliminated to reflect current industry practices. These proposed changes in procedures for cotton futures quality classification services, as well as proposed conforming changes, reflect advances in cotton fiber quality measurement and data processing made since the regulations were last updated in 1992.
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