February 10, 2009 – Federal Register Recent Federal Regulation Documents

In accordance with the memorandum of January 20, 2009 from the Assistant to the President and Chief of Staff, entitled ``Regulatory Review,'' CMS is seeking public comment on a contemplated delay of 60 days in the effective date of the rule entitled ``Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA),'' published in the Federal Register on January 16, 2009 (74 FR 2873). That rule implements certain MIPPA provisions that delay implementation of Round 1 of the competitive bidding program; requires CMS to conduct a second Round 1 competition (the ``Round 1 rebid'') in 2009; and mandates certain changes for both the Round 1 rebid and subsequent rounds of the program, including a process for providing feedback to suppliers regarding missing financial documentation and requiring contractors to disclose to CMS information regarding subcontracting relationships. CMS is considering a temporary 60-day delay in effective date to allow CMS officials the opportunity for further review of the issues of law and policy raised by this rule, consistent with the Chief of Staff's memorandum of January 20, 2009. CMS solicits comments specifically on the contemplated delay in effective date and generally on the rule entitled ``Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA).''

The Food and Drug Administration (FDA) has determined the regulatory review period for SELZENTRY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA), Office of Regulatory Affairs, Southwest Regional Small Business Representative (SWR SBR) Program, in collaboration with The University of Arkansas, is announcing a public workshop entitled ``Food Labeling Workshop.'' This public workshop is intended to provide information about FDA food labeling regulations and other related subjects to the regulated industry, particularly small businesses and startups. Date and Time: This public workshop will be held on April 21, 2009, from 8 a.m. to 5 p.m., and on April 22, 2009, from 8 a.m. to 4 p.m. Location: The public workshop will be held at the Continuing Education Center, Two East Center St., Fayetteville, AR (located downtown). Contact: David Arvelo, Small Business Representative, Food and Drug Administration, Southwest Regional Office, 4040 North Central Expressway, suite 900, Dallas, TX 75204, 214-253-4952, FAX: 214-253- 4970, or e-mail: david.arvelo@fda.hhs.gov. For information on accommodation options, contact Steven C. Seideman, 2650 North Young Ave., Institute of Food Science & Engineering, University of Arkansas, Fayetteville, AR 72704, 479-575- 4221, FAX: 479-575-2165, or e-mail: seideman@uark.edu. Registration: You are encouraged to register by April 10, 2009. The University of Arkansas has a $250 registration fee to cover the cost of facilities, materials, and breaks. Seats are limited; please submit your registration as soon as possible. Course space will be filled in order of receipt of registration. Those accepted into the course will receive confirmation. Registration will close after the course is filled. Registration at the site is not guaranteed but may be possible on a space available basis on the day of the public workshop beginning at 8 a.m. The cost of registration at the site is $350 payable to: ``The University of Arkansas.'' If you need special accommodations due to a disability, please contact Steven C. Seideman (see Contact) at least 14 days in advance. Registration Instructions: To register, please submit your name, affiliation, mailing address, phone/fax number, and e-mail, along with a check or money order for $250 payable to the ``The University of Arkansas.'' Mail to: Institute of Food Science & Engineering, University of Arkansas, 2650 North Young Ave., Fayetteville, AR 72704. Transcripts: Transcripts of the public workshop will not be available due to the format of this workshop. Course handouts may be requested at cost through the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857, approximately 15 working days after the public workshop at a cost of 10 cents per page.

The duties of the Task Force are to prepare and approve a plan for the use of the funds made available under Title IX to promote conservation practices in the Missouri River watershed, control and remove the sediment from the Missouri River, protect recreation on the Missouri River from sedimentation, and protect Indian and non-Indian historical and cultural sites along the Missouri River from erosion.

The U.S. Army Corps of Engineers (COE), Wilmington District, Wilmington Regulatory Division is issuing this notice to advise the public that a State of North Carolina funded Draft Environmental Impact Statement (DEIS) will be prepared for the improvement of US 64 to a multilane facility, and replacement of the Lindsey C. Warren bridge in Tyrrell and Dare Counties, North Carolina (TIP Projects R-2544 and R- 2545).

The Food and Drug Administration (FDA) is extending to March 19, 2009, the comment period for the draft guidance for industry entitled ``Bioequivalence Recommendation for Vancomycin HCl'' that published in the Federal Register of December 16, 2008 (73 FR 76362). The draft guidance provides specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for vancomycin HCl capsules. FDA is taking this action in response to requests for an extension of the comment period to allow interested persons additional time to submit comments.

The EPA Science Advisory Board (SAB) Staff Office announces a public teleconference of the SAB Integrated Nitrogen Committee (INC) to discuss the committee's draft report.

The U.S. Marine Corps is proposing to alter system of records notice to its existing inventory of records systems subject to the Privacy Act of 1974, (5 U.S.C. 552a), as amended.

The Office of the Inspector General (OIG) is amending a system of records notice in its existing inventory of record systems subject to the Privacy Act of 1974, (5 U.S.C. 552a), as amended.

Emera Energy Services, Inc. (EES) has applied to renew its authority to transmit electric energy from the United States to Canada pursuant to section 202(e) of the Federal Power Act.

The Office of the Secretary of Defense is altering a system of records notice in its existing inventory of record systems subject to the Privacy Act of 1974, (5 U.S.C. 552a), as amended.

The Defense Finance and Accounting Service (DFAS) is proposing to add a system of records notice to its inventory of record systems subject to the Privacy Act of 1974, (5 U.S.C. 552a), as amended.

The National Security Agency/Central Security Service is proposing to amend an exempt system of records to its existing inventory of record systems subject to the Privacy Act of 1974, (5 U.S.C. 552a), as amended.

The Department of Air Force proposes to amend a system of records to its inventory of record systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended.

NMFS announces that the annual harvest guideline for the commercial lobster fishery in the Northwestern Hawaiian Islands (NWHI) for calendar year 2009 is established at zero lobsters.

The Department of State is seeking Office of Management and Budget (OMB) approval for the information collection described below. The purpose of this notice is to allow 60 days for public comment in the Federal Register preceding submission to OMB. We are conducting this process in accordance with the Paperwork Reduction Act of 1995. Title of Information Collection: Electronic Application for Immigrant Visa and Alien Registration. OMB Control Number: None. Type of Request: New Collection. Originating Office: Department of State, Bureau of Consular Affairs, Visa Services (CA/VO). Form Number: DS-260. Respondents: Aliens applying for an immigrant visa. Estimated Number of Respondents: 700,000. Estimated Number of Responses: 700,000. Average Hours per Response: 120 minutes (2 hours). Total Estimated Burden: 1,400,000 hours per year. Frequency: Once per respondent. Obligation To Respond: Required To Obtain or Retain a Benefit.

The United States Department of State published a notice of intent in the Federal Register on January 28, 2009, (74 FR 5019) announcing its intent to prepare an environmental impact statement (EIS) for the proposed Keystone international pipeline project (the Keystone XL Project), which is designed to transport crude oil production from the Western Canadian Sedimentary Basin to existing markets in the Texas Gulf Coast area. The document contained the incorrect time for the public scoping meeting to be held in Faith, South Dakota on February 26, 2009. Correction: In the Federal Register of January 28, 2009, in FR Doc. E9-1828, on page 5020, the following corrections should be made for the announced time of public meeting to be held in Faith, South Dakota: Meeting date: Thursday, February 26, 12-2 p.m. Location: Faith, SD. Venue: Community Legion Hall, Main Street, Faith, SD 57626.

The Wenatchee-Okanogan Resource Advisory Committee will meet on Thursday, February 26, and Wednesday, March 4 at the Okanogan- Wenatchee National Forest Headquarters Office, 215 Melody Lane, Wenatchee, WA, and on March 18 at the Rural County Fire District 1 Sunnyslope Fire Station, 206 Easy Street, Wenatchee, WA. These meetings will begin at 9 a.m. and continue until 3 p.m. On February 26, committee members will review Okanogan County projects, on March 4, committee members will review Chelan County projects, and on March 18, committee members will review Kittitas County and Yakima County projects proposed for Resource Advisory Committee consideration under Title II of the Secure Rural Schools and Community Self- Determination Act of 2000. All Wenatchee-Okanogan Resource Advisory Committee meetings are open to the public. Interested citizens are welcome to attend.

The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices or unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the draft complaint and the terms of the consent orderembodied in the consent agreementthat would settle these allegations.

The Office of the Secretary of Defense is amending a system of records notice in its existing inventory of record systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended.