April 8, 2013 – Federal Register Recent Federal Regulation Documents
Results 101 - 128 of 128
Designation of Product Categories for Federal Procurement; Withdrawal
The U.S. Department of Agriculture (USDA) is withdrawing the final rule ``Designation of Product Categories for Federal Procurement'' published April 1, 2013, at 78 FR 19393. The final rulemaking, which amended the Guidelines for Designating Biobased Products for Federal Procurement, to add eight sections to designate product categories within which biobased products will be afforded Federal procurement preference, was published prematurely due to an oversight in the development process.
Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority
As part of its continuing effort to reduce paperwork burden and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s). Comments are requested concerning: 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; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; 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 ways to further reduce the information burden for 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.
Information Collection(s) Being Submitted for Review and Approval to the Office of Management and Budget (OMB)
As part of its continuing effort to reduce paperwork burden and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3502-3520), the Federal Communications Commission invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s). Comments are requested concerning: 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; the accuracy of the Commission's burden estimates; ways to enhance the quality, utility, and clarity of the information collected; 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 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.
Information Collection(s) Being Reviewed by the Federal Communications Commission, Comments Requested
As part of its continuing effort to reduce paperwork burden and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s). Comments are requested concerning: 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; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; 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 ways to further reduce the information burden for 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.
Consumer Advisory Committee
The Commission announces rechartering, appointment of members and designation of chairperson of its Consumer Advisory Committee (Committee). The Commission further announces the Committee's next meeting date, time, and agenda. The purpose of the Committee is to make recommendations to the Commission regarding matters within the jurisdiction of the Commission and to facilitate the participation of all consumers in proceedings before the Commission.
Solicitation of Federal Civilian and Uniformed Service Personnel for Contributions to Private Voluntary Organizations
The United States Office of Personnel Management (OPM) is issuing a proposed rule to amend the Combined Federal Campaign (CFC) regulations in order to strengthen the integrity, streamline the operations and increase the effectiveness of the program to ensure its continued growth and success.
Application for Final Commitment for a Long-Term Loan or Financial Guarantee in Excess of $100 million: AP087801XX
This Notice is to inform the public, in accordance with Section 3(c)(10) of the Charter of the Export-Import Bank of the United States (``Ex-Im Bank''), that Ex-Im Bank has received an application for final commitment for a long-term loan or financial guarantee in excess of $100 million (as calculated in accordance with Section 3(c)(10) of the Charter). Comments received within the comment period specified below will be presented to the Ex-Im Bank Board of Directors prior to final action on this Transaction. Reference: AP087801XX. Purpose and Use: Brief description of the purpose of the transaction: To support the export of U.S. manufactured commercial aircraft to China. Brief non-proprietary description of the anticipated use of the items being exported: To provide short-and medium haul airline service in China and between China and other regional destinations and to provide long-haul airline service between China and various international destinations. To the extent that Ex-Im Bank is reasonably aware, the item(s) being exported may be used to produce exports or provide services in competition with the exportation of goods or provision of services by a United States industry. Parties:
Center for Devices and Radiological Health: Health of Women Program; Public Workshop; Request for Comments
The Food and Drug Administration (FDA) is announcing the following public workshop: ``The Center for Devices and Radiological Health (CDRH) Health of Women (HoW) Program: Educate, Enable, Enlist and ExploreHoW to Improve the Health of Women.'' CDRH is developing the HoW Program to explore unique issues in the regulation of medical devices related to the health of women and seeks public input on the priority activities. The CDRH HoW program seeks to bring together industry, clinicians, researchers, academia, government agencies, and patient/advocacy groups in an effort to: (1) Highlight device-specific clinical Study recruitment and retention strategies; (2) improve analysis and communication of sex-specific findings to providers and patients; (3) develop a priority research road map for the HoW device ecosystem. The workshop focus will be device- and disease-specific, patient centered, and action oriented. Dates and Times: The public workshop will be held on June 24, 2013, from 8 a.m. to 5 p.m. and June 25, 2013, from 8 a.m. to 5 p.m. Location: The public workshop will be held on FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD 20993. Contact: Nada Hanafi, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5422, Silver Spring, MD 20993-0002, 301-796-5427, Nada.Hanafi@fda.hhs.gov; or Kathryn O'Callaghan, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5568, Silver Spring, MD 20993-0002, 301-796-6349, Kathryn.OCallaghan@fda.hhs.gov. Registration: Registration is free and available on a first-come, first-served basis. Persons interested in attending this public workshop must register online by 5 p.m. on June 14, 2013. Early registration is recommended because facilities are limited and, therefore, FDA may limit the number of participants from each organization. If time and space permits, onsite registration will be provided beginning at 7:30 a.m. on the day of the public workshop. If you need special accommodations due to a disability, please contact Joyce Raines (Joyce.Raines@fda.hhs.gov or 301-796-5709) by 5 p.m. on June 14, 2013. To register for the public workshop, please visit FDA's Medical Devices News & EventsWorkshops & Conferences calendar at https:// www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/de fault.htm and select this public workshop from the posted events list. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, telephone number and primary HoW Program area of expertise or interest. Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list. Streaming Webcast of the public workshop: The plenary portions of this workshop will be Webcast. Persons interested in viewing the Webcast must register online by 5 p.m. on June 14, 2013. Early registration is recommended because Webcast connections are limited. Organizations are requested to register all participants, but to view using one connection per location. Webcast participants will be sent technical system requirements after registration and connection access information after June 19, 2013. An archived file of the Webcast will be available approximately 45 days after the public workshop on the Internet at https://www.fda.gov/MedicalDevices/NewsEvents/ WorkshopsConferences/default.htm. (Select this public workshop from the posted events list). Workshop format: This workshop will begin with plenary sessions to outline the three primary areas of focus for the CDRH HoW Program. In each area, panels will examine major themes using data-driven case studies with a focus on practical strategies relevant to particular challenges in the medical device arena. Participants will then rotate through breakout sessions, collectively building an action plan for each activity area. The meeting will conclude with specific commitments by stakeholder groups to partner with CDRH and each other in a collaborative effort to educate, enable, enlist and explore, with a common goal of improving the health of women. Comments: In order to permit the widest possible opportunity to obtain public information from interested persons on the workshop topics, FDA is opening the docket to gather electronic or written comments on the three areas of focus for the HoW workshop identified in section II. Comments received will be reviewed by FDA as part of this effort. The deadline for submitting comments related to this public workshop topic is July 31, 2013. Regardless of attendance at the public workshop, interested persons may submit either electronic or written comments. Submit electronic comments to https://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. Please identify comments with the docket number found in brackets in the heading of this document. In addition, when responding to specific topics as outlined in section II, please identify the topic you are addressing. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov.
Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format (Periodic Benefit-Risk Evaluation Report); Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report).'' This guidance is intended to inform applicants of the conditions under which FDA will exercise its waiver authority to permit applicants to submit an International Conference on Harmonisation (ICH) E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER) in place of the ICH E2C(R1) Periodic Safety Update Report (PSUR), U.S. periodic adverse drug experience report (PADER), or U.S. periodic adverse experience report (PAER), to satisfy the periodic safety reporting requirements in FDA regulations. The guidance describes the steps applicants can take to submit the PBRER, and discusses the format, content, submission deadline, and frequency of reporting for the PBRER.
Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability
The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products,'' which explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.
Center for Biologics Evaluation and Research eSubmitter Pilot Evaluation Program for Investigational New Drug Applications
The Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research (CBER) is announcing an invitation to sponsors of investigational new drug (IND) applications to participate in a pilot evaluation program for CBER's eSubmitter Program (eSubmitter). CBER's eSubmitter is a computer-assisted automated program that has been customized to facilitate the creation of IND applications in electronic format, including a template specifically for IND applications related to antivenom drugs/antivenins. Participation in the pilot program is open to sponsors that submit IND applications to the Office of Blood Research and Review, the Office of Cellular, Tissue and Gene Therapy, or the Office of Vaccines Research and Review in CBER. CBER will only accept participation from up to nine sponsors. The pilot program is intended to provide industry and CBER regulatory review staff with an opportunity to evaluate the eSubmitter system and determine if it facilitates the IND submission process. The purpose of this notice is to invite sponsors of IND applications to contact CBER for more information if they are interested in participating in this pilot program.
Mid-Atlantic Fishery Management Council (MAFMC); Public Meeting
The Mid-Atlantic Fishery Management Council's (Council) Surfclam and Ocean Quahog Advisory Panel will hold a public meeting.
Reporting and Recordkeeping Requirements Under OMB Review
Under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35), agencies are required to submit proposed reporting and recordkeeping requirements to OMB for review and approval, and to publish a notice in the Federal Register notifying the public that the agency has made such a submission.
Approval and Promulgation of Implementation Plans; Mississippi; 110(a)(2)(E)(ii) Infrastructure Requirements for the 1997 and 2006 Fine Particulate Matter National Ambient Air Quality Standards
EPA is taking final action to approve in part, and disapprove in part, the State Implementation Plan (SIP) submission, provided by the Mississippi Department of Environmental Quality (MDEQ), on October 11, 2012. This submission pertains to specific Clean Air Act (CAA) requirements for the 1997 annual and 2006 24-hour fine particulate matter (PM2.5) National Ambient Air Quality Standards (NAAQS) infrastructure SIPs. This action focuses on one component of the infrastructure requirements in the CAA. The CAA requires states to include provisions in their SIP to address conflicts of interest for state boards or bodies that approve CAA permits and enforcement orders and disclosure of conflict of interest requirements. Specifically, EPA is now approving the submission as it relates to the public interest requirements of CAA and the conflict of interest disclosure provisions. EPA is also now disapproving Mississippi's submission only as it pertains to compliance with the significant portion of income requirements of the CAA. Through this action, EPA is only taking action on the infrastructure SIP requirement related to Mississippi's obligation to address conflicts of interest requirements for state boards or bodies that approve CAA permits and enforcement orders and disclosure of conflict of interest requirements. All other applicable Mississippi infrastructure elements for the 1997 annual and 2006 24- hour PM2.5 NAAQS have been addressed through separate rulemakings. EPA is also taking action to finalize substantive SIP revisions included with MDEQ's October 11, 2012, submission.
Tonto National Forest; Arizona; Salt River Allotments Vegetative Management EIS
The Tonto National Forest hereby gives notice that it is extending the public comment period for the Salt River Allotments Vegetative Management Draft Environmental Impact Statement (Draft EIS), which was published in the Federal Register on February 22, 2013, (Volume 78, No. 36) originally for a 45-day comment period. Please see the Notice of Availability of the Draft EIS (78 FR 12310) for more detailed information related to the Salt River Allotments Vegetative Management Draft EIS. In response to requests for additional time, the Forest Service will extend the comment period from April 8, 2013, to May 8, 2013. Federal, State, tribal, and local governments and other interested parties are requested to comment on the Draft EIS. Comments will be accepted by email to comments-southwestern-tonto@fs.fed.us or by mail to Debbie Cress, Tonto National Forest, 2324 E. McDowell Rd., Phoenix, AZ 85006 (928) 595-2093 or faxed to (602) 225-5295.
Dual and Multiple Associations of Persons Associated With Swap Dealers, Major Swap Participants and Other Commission Registrants
The Commodity Futures Trading Commission (Commission or CFTC) is adopting regulations to make clear that each swap dealer (SD), major swap participant (MSP), and other Commission registrant with whom an associated person (AP) is associated is required to supervise the AP and is jointly and severally responsible for the activities of the AP with respect to customers common to it and any other SD, MSP or other Commission registrant.
Swap Dealers and Major Swap Participants; Clerical or Ministerial Employees
The Commodity Futures Trading Commission (Commission or CFTC) is proposing to amend its regulations (Proposal) to clarify certain responsibilities of a swap dealer (SD) or major swap participant (MSP) regarding its employees who solicit, accept or effect swaps in a clerical or ministerial capacity.
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