January 13, 2009 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices.'' The guidance provides drug, biologics, and device manufacturers with the agency's views on the distribution of medical journal articles and scientific or medical reference publications that discuss unapproved new uses for FDA- approved drugs or biologics or FDA-approved or cleared medical devices to healthcare professionals and healthcare entities.

The Food and Drug Administration (FDA) is seeking information and comments on issues related to the enrollment of certain populations in clinical drug trials. Particularly, we are requesting information and comments from medical product manufacturers, institutional review boards (IRBs), patient groups, universities, researchers, community groups, and other interested parties. This request is related to FDA's implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA) section 901, which requires recommendations be included in a report to Congress addressing best practice approaches on increasing the participation of elderly populations, children, racially and ethnically diverse communities, and medically underserved populations in clinical drug trials. FDA requests that those with information on possible approaches to increase participation of these groups in clinical drug trials submit comments.

The Homeland Security Information Network Advisory Committee will hold a teleconference call on January, 26, 2009, to discuss implementation efforts associated with the Next Generation of the Homeland Security Information Network. This notice supersedes the notice announcing a teleconference meeting scheduled to take place on January 13, 2009. No teleconference call will take place on January 13, 2009. Teleconference call dates may be subject to change. Please contact Niklaus Welter in advance of the call to confirm that the call will take place.

The Federal Transit Administration (FTA) and the Florida Department of Transportation (FDOT) issue this notice to advise governmental agencies, the public and other interested stakeholders of FTA's and FDOT's intent to continue the early scoping and planning- level National Environmental Policy Act (NEPA)/Florida's Efficient Transportation Decision Making (ETDM) process previously initiated for the South Florida East Coast Corridor Transit Analysis (SFECCTA) study. This notice is announcing to interested parties that additional early scoping meetings will be held at the beginning of the second phase of early scoping/ETDM on the dates provided below, and to inform the general public regarding the ongoing planning process. The FTA and FDOT have been exploring transportation alternatives along an 85-mile section of the existing Florida East Coast (FEC) Railway freight corridor between Miami and Tequesta, Florida. A programmatic Tier 1 Draft Environmental Impact Statement (DEIS) developed an approach for evaluating impacts associated with various transportation improvement alternatives. The Tier 1 DEIS identified a number of transportation improvement alternatives that will be further evaluated in the continuation of the early scoping/ETDM process. This process is intended to result in selection of one or more locally- preferred transportation improvement alternatives. FDOT has been engaged in alternatives analysis and produced the Final Conceptual Alternatives Analysis/Environmental Screening Report (AA/ESR) that documents the results of the first phase of the SFECCTA planning. An electronic copy of this interim report is available upon request from the contact below. With the continuation of early scoping, the FTA and FDOT will discontinue the pursuit of a Tiered Programmatic EIS process and continue the statutorily required Alternatives Analysis process. Within this process, it is FDOT's intention to screen alternatives and determine transportation mode and general alignment within the corridor for each of the three independent corridor sections. At the conclusion of the early scoping process, the locally approved alternatives (LPAs) for each corridor segment will be adopted by the individual Metropolitan Planning Organizations and the Long Range Transportation Plans will be updated. FTA and FDOT will then prepare a Draft Environmental Impact Statement incorporating by reference all early scoping environmental planning efforts.

The OCC, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. An agency may not conduct or sponsor, and a respondent is not required to respond to, an information collection unless it displays a currently valid OMB control number. The OCC is soliciting comment concerning its information collection titled, ``Recordkeeping Requirements for Securities Transactions12 CFR part 12.''

The Federal Highway Administration (FHWA) is issuing this revised notice to advise the public, affected Tribal nations, and agencies that an environmental impact statement (EIS) will be prepared for a proposal to expedite construction of pontoons needed to replace the floating section of the SR 520 Evergreen Point Bridge in the event of a catastrophic failure.

This is a notice of an Economic Injury Disaster Loan (EIDL) declaration for the State of Maine, dated 01/06/2009. Incident: Fire. Incident Period: 09/14/2008.

This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the Commonwealth of Massachusetts (FEMA1813DR), dated 01/05/2009. Incident: Severe Winter Storm and Flooding. Incident Period: 12/11/2008 and continuing.

This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of Hawaii (FEMA-1814- DR), dated 01/05/2009. Incident: Severe Storms and Flooding. Incident Period: 12/10/2008 through 12/16/2008. Effective Date: 01/05/2009. Physical Loan Application Deadline Date: 03/06/2009. Economic Injury (EIDL) Loan Application Deadline Date: 10/05/2009.

This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of New Hampshire (FEMA-1812-DR), dated 01/02/2009. Incident: Severe Winter Storm. Incident Period: 12/11/2008 and continuing.

The Federal Trade Commission announces the revised thresholds for the Hart-Scott-Rodino Antitrust Improvements Act of 1976 required by the 2000 amendment of Section 7A of the Clayton Act. Section 7A of the Clayton Act, 15 U.S.C. 18a, as added by the Hart-Scott-Rodino Antitrust Improvements Act of 1976, Pub. L. 94-435, 90 Stat. 1390 (``the Act''), requires all persons contemplating certain mergers or acquisitions, which meet or exceed the jurisdictional thresholds in the Act, to file notification with the Commission and the Assistant Attorney General and to wait a designated period of time before consummating such transactions. Section 7A(a)(2) requires the Federal Trade Commission to revise those thresholds annually, based on the change in gross national product, in accordance with Section 8(a)(5). The new thresholds, which take effect 30 days after publication in the Federal Register, are as follows:

This gives notice of OPM decisions granting authority to make appointments underSchedules A, B, and C in the excepted service as required by 5 CFR 6.6 and 213.103.

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.