November 2010 – Federal Register Recent Federal Regulation Documents
Results 251 - 300 of 2,637
Findings of Misconduct in Science
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Bengu Sezen, Ph.D., Columbia University: Based on the findings of an investigation by Columbia University (CU) and additional analysis conducted by the Office of Research Integrity (ORI) during its oversight review, ORI found that Bengu Sezen, former graduate student, Department of Chemistry, CU, engaged in misconduct in science in research funded by National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), grant R01 GM60326. Specifically, ORI made twenty-one (21) findings of scientific misconduct against Dr. Sezen based on evidence that she knowingly and intentionally falsified and fabricated, and in one instance plagiarized, data reported in three (3) papers \1\ and her doctoral thesis.
Health Center Program
The Health Resources and Services Administration (HRSA) will transfer Health Center Program (section 330 of the Public Health Service Act) Increased Demand for Services (IDS) and Capital Improvement Project (CIP) funds, awarded under the American Recovery and Reinvestment Act (ARRA), originally awarded to Harlem United Community AIDS Center, Inc. (HUCAC) to Upper Room AIDS Ministry, Inc. to ensure the provision of critical primary health care services and continuity of services to low-income, underserved homeless patients in New York City.
Part C Early Intervention Services Grant under the Ryan White HIV/AIDS Program
HRSA will be giving a non-competitive one-time replacement award to support comprehensive primary care services for persons living with HIV/AIDS, including primary medical care, laboratory testing, oral health care, outpatient mental health and substance abuse treatment, specialty and subspecialty care, referrals for health and support services and adherence monitoring/education services to the Louisiana State University, Health Sciences Center, Viral Disease Clinic to ensure continuity of critical HIV medical care and treatment services, to clients in Shreveport, Louisiana.
Notice of Correction to Notice of Availability of the Environmental Assessment and Notice of Public Hearing for the Sage Creek Holdings, LLC, Federal Coal Lease Application, COC-74219
The Bureau of Land Management (BLM) is correcting the Notice of Availability of the Environmental Assessment (EA) and Notice of Public Hearing for the Sage Creek Holdings, LLC, Federal Coal Lease Application, COC-74219 published in the Federal Register on August 13, 2010 [75 FR 49512]. The BLM incorrectly stated that the EA was complete and available for release. The BLM subsequently determined that additional information should have been included in the cumulative impact section of the EA. The BLM will be issuing a revised EA, which will be available for a 30-day comment period upon completion. After the end of the comment period, the BLM will hold a public hearing on the EA, the fair market value and the maximum economic recovery of the proposed leased tract.
Proposed Information Collections; Comment Request
As part of our continuing effort to reduce paperwork and respondent burden, and as required by the Paperwork Reduction Act of 1995, we invite comments on the proposed or continuing information collections listed below in this notice.
Third Party Testing for Certain Children's Products; Mattresses, Mattress Pads, and/or Mattress Sets: Revisions to Terms of Acceptance of Children's Product Certifications Based on Third Party Conformity Assessment Body Testing Prior to Commission's Acceptance of Accreditation
The Consumer Product Safety Commission (``CPSC,'' ``Commission,'' or ``we'') is issuing a notice amending the terms under which it will accept certifications for children's products based on third party conformity assessment body (laboratory) testing to the flammability regulations at 16 CFR parts 1632 and/or 1633 that occurred before the Commission's acceptance of the accreditation of the third party conformity assessment body. We are taking this action in response to requests from certain mattress manufacturers to reduce unnecessary retesting of mattresses, mattress pads, and/or mattress sets that have already been tested and found to be in compliance with CPSC regulations.
Agency Information Collection Activities; Proposed Collection; Comment Request; Prize Competitions and Contests
The Consumer Product Safety Commission (``CPSC'' or ``Commission'') is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (``the PRA''), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the proposed collection of information for CPSC-sponsored prize competitions or contests.
Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Drug User Fee Cover Sheet, Form 3546
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on burden hours necessary to complete FDA Form 3546, Animal Drug User Fee Act (ADUFA) Cover Sheet.
Disapproval and Promulgation of Air Quality Implementation Plans; Indiana; Addition of Incentive for Regulatory Flexibility for Its Environmental Stewardship Program
On July 6, 2007, the Indiana Department of Environmental Management (IDEM) submitted a request to EPA to amend its State Implementation Plan (SIP) to add incentives for regulatory flexibility for participants in its Environmental Stewardship Program (ESP) and Comprehensive Local Environmental Action Network (CLEAN) Community Challenge Program. Indiana requested that EPA approve the following for ESP and CLEAN members: The incorporation by reference of certain incentives under the National Environmental Performance Track (NEPT) Program, monthly averaging of volatile organic compound (VOC) coating limits, and the processing of pollution prevention projects as minor permit revisions. EPA proposed to disapprove these three incentives on August 19, 2010, and received no comments.
Notice of Public Information Collection(s) Being Reviewed by the Federal Communications Commission, Comments Requested
The Federal Communications Commission, as part of its continuing effort to reduce paperwork burden invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s), as required by the Paperwork Reduction Act (PRA) of 1995, 44 U.S.C. 3501-3520. Comments are requested concerning: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimate; (c) ways to enhance the quality, utility, and clarity of the information collected; (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and (e) ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a valid OMB control number.
Approval and Promulgation of Air Quality Implementation Plans; Maryland; Control of Volatile Organic Compound Emissions From Industrial Solvent Cleaning Operations; Withdrawal of Direct Final Rule
Due to an adverse comment, EPA is withdrawing the direct final rule to approve revisions to Maryland's State Implementation Plan (SIP). This SIP revision consists of an addition to Maryland's Volatile Organic Compounds from Specific Processes Regulation. Maryland Department of the Environment (MDE) adopted standards for industrial solvent cleaning operations that satisfy the reasonably available control technology (RACT) requirements for sources of volatile organic compounds (VOCs) covered by control techniques guidelines (CTG). In the direct final rule published on September 29, 2010 (75 FR 59973), we stated that if we received any adverse comments by October 29, 2010, the rule would be withdrawn and would not take effect. EPA received an adverse comment within the comment period. EPA will address the comment received in a subsequent final action based upon the proposed action also published on September 29, 2010 (75 FR 60013). EPA will not institute a second comment period on this action.
Human Studies Review Board (HSRB); Notification of a Public Teleconference To Review Draft Report From the October 27-28, 2010 HSRB Meeting
The EPA Human Studies Review Board (HSRB) announces a public teleconference meeting to discuss its draft report from the October 27- 28, 2010 HSRB meeting.
Brokers of Household Goods Transportation by Motor Vehicle
FMCSA amends its regulations to require brokers that arrange the transportation of household goods in interstate or foreign commerce for consumers to comply with certain consumer protection requirements. Brokers must provide: their U.S. DOT number on their advertisements and Internet Web sites; estimates of expected moving charges and brokerage fees; FMCSA pamphlets containing tips for successful moves and the consumer's rights and responsibilities; and the broker's policies concerning deposits, cancellations, and refunds. This rulemaking is in response to the Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users (SAFETEA-LU) and a petition for rulemaking from the American Moving and Storage Association. This rulemaking is intended to ensure that individual shippers who arrange for transportation of household goods through brokers receive necessary information regarding their rights and responsibilities in connection with interstate household goods moves.
Change in Rates and Classes of General Applicability for Competitive Products
This notice sets forth changes in rates of general applicability for competitive products.
Draft Guidance for Industry on Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Hospital- Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment.'' The purpose of this draft guidance is to assist clinical trial sponsors and investigators in the development of antimicrobial drugs for the treatment of hospital- acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP). The science of clinical trial design and our understanding of these diseases have advanced in recent years, and this draft guidance, when finalized, will inform sponsors of the recommendations for clinical development.
Guidance for Industry on Antibacterial Drug Products: Use of Noninferiority Trials to Support Approval; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Antibacterial Drug Products: Use of Noninferiority Trials to Support Approval.'' The purpose of this guidance is to provide information on FDA's current thinking regarding appropriate use of noninferiority (NI) clinical trial designs to evaluate antibacterial drug products. The Agency's thinking in this area has evolved in recent years in response to a number of public discussions on the use of active-controlled trials designed to show NI as the basis for approval of antibacterial drug products. This guidance finalizes the draft guidance published in the Federal Register of October 15, 2007.
Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling.'' FDA is issuing this guidance with labeling recommendations because of concerns that both healthcare providers and patients may be unaware of the serious adverse health risks associated with using the same blood lancet device for assisted withdrawal of blood from more than one patient, even when the lancet blade is changed for each blood draw. FDA recommends that all blood lancet devices be labeled for use only on a single patient. A statement limiting use to a single patient should also appear on the label attached to the device, if possible. The guidance document is immediately in effect, but it remains subject to comment in accordance with the Agency's good guidance practices.
Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Clostridium difficile; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Clostridium difficile.'' This draft guidance document describes FDA's recommendations concerning 510(k) submissions for various types of in vitro diagnostic devices (IVDs) intended to be used for detecting Clostridium difficile (C. difficile). This draft guidance is not final nor is it in effect at this time.
Approval and Promulgation of Air Quality Implementation Plans; Indiana; Clean Air Interstate Rule
EPA is proposing to approve a request submitted by the Indiana Department of Environmental Management (IDEM) on June 29, 2009, to revise the Indiana State Implementation Plan (SIP) under the Clean Air Act (CAA). The State has submitted amendments to the Indiana Administrative Code (IAC), which supplement Indiana's Clean Air Interstate Rule (CAIR), for which EPA granted limited approval as an abbreviated SIP on October 22, 2007. The State's June 29, 2009, submittal includes elements that EPA deems necessary in order for EPA to fully approve Indiana's CAIR SIP. This will allow a transition from an abbreviated SIP with limited approval to a full SIP with full approval under which the various CAIR implementation provisions would be governed by State rules rather than Federal Implementation Plan (FIP) rules. This action results in the withdrawal of the Indiana CAIR FIP concerning sulfur dioxide (SO2), nitrogen oxides (NOX) annual, and NOX ozone season emissions.
Approval and Promulgation of Air Quality Implementation Plans; Indiana; Clean Air Interstate Rule
EPA is taking direct final action to approve a request submitted by the Indiana Department of Environmental Management (IDEM) on June 29, 2009, to revise the Indiana State Implementation Plan (SIP) under the Clean Air Act (CAA). The State has submitted amendments to the Indiana Administrative Code (IAC), which supplement Indiana's Clean Air Interstate Rule (CAIR), for which EPA granted limited approval as an abbreviated SIP on October 22, 2007. The abbreviated SIP was to be implemented in conjunction with a Federal Implementation Plan (FIP) that specified requirements for emissions monitoring, permit provisions, and other elements of CAIR programs. The State's June 29, 2009, submittal includes elements that EPA deems necessary in order for EPA to fully approve Indiana's CAIR SIP. This will allow a transition from an abbreviated SIP with limited approval to a full SIP with full approval under which the various CAIR implementation provisions would be governed by State rules rather than FIP rules. This action results in the withdrawal of the Indiana CAIR FIP concerning sulfur dioxide (SO2), nitrogen oxides (NOX) annual, and NOX ozone season emissions.
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