2007 – Federal Register Recent Federal Regulation Documents

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 emergency processing under the Paperwork Reduction Act of 1995 (the PRA). The proposed collection of information is an amendment to OMB control number 0910-0167 and concerns the joint adoption by FDA and the European Medicines Evaluation Agency (EMEA) of the Common EMEA/FDA Application Form for Orphan Medicinal Product Designation (form FDA 3671).

The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved by the Center for Biologics Evaluation and Research (CBER). This list is intended to inform the public of the availability through the Internet and FDA's Division of Dockets Management of summaries of safety and effectiveness data of approved PMAs.

This Notice announces that employers petitioning for temporary or seasonal agricultural workers coming to the United States under the H-2A nonimmigrant classification must file their petitions at U.S. Citizenship and Immigration Service's California Service Center. Receiving all H-2A petitions at the designated California Service Center will enable U.S. Citizenship and Immigration Services to reduce overall petition processing times and better monitor the adjudication of H-2A petitions.

The deadline for U.S. accredited colleges and universities to sponsor the U.S. Electronic Education Fairs for China and India by purchasing space on the corresponding Internet landing pages has been extended to November 16, 2007.

As authorized by Pub. L. 105-383 and Pub. L. 107-295, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.- build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below. The complete application is given in DOT docket MARAD-2007-0007 at https:// www.regulations.gov. Interested parties may comment on the effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. If MARAD determines, in accordance with Pub. L. 105-383 and MARAD's regulations at 46 CFR part 388 (68 FR 23084; April 30, 2003), that the issuance of the waiver will have an unduly adverse effect on a U.S. vessel builder or a business that uses U.S.-flag vessels in that business, a waiver will not be granted. Comments should refer to the docket number of this notice and the vessel name in order for MARAD to properly consider the comments. Comments should also state the commenter's interest in the waiver application, and address the waiver criteria given in Sec. 388.4 of MARAD's regulations at 46 CFR part 388.

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 the application for participation in the Medical Device Fellowship Program (MDFP).

As part of its continuing effort to reduce paperwork and respondent burden, CBP invites the general public and other Federal agencies to comment on an information collection requirement concerning the Arrival and Departure Record, Forms I-94 and I-94W. This request for comment is being made pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104-13; 44 U.S.C. 3505(c)(2)).

In compliance with the Paperwork Reduction Act of 1995, this notice announces that the Information Collection abstracted below will be submitted to the Office of Management and Budget (OMB) for review and approval. The nature of the information collection is described as well as its expected burden. The Federal Register Notice with a 60-day comment period soliciting comments on the following collection of information was published on July 20, 2007. No comments were received.

The Department of the Treasury, 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 proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning instructions on how to apply for a Central Withholding Agreement.

The Environmental Protection Agency (EPA) is taking direct final action on motor vehicle refrigerant recovery and recycling equipment standards. Under Clean Air Act Section 609, motor vehicle air-conditioning (MVAC) refrigerant handling equipment must be certified by the Administrator or an independent organization approved by the Administrator and, at a minimum, must be as stringent as the standards of the Society of Automotive Engineers (SAE) that are in effect as of the date of the enactment of the Clean Air Act Amendments of 1990. In 1997, EPA promulgated regulations that required the use of SAE Standard J2210, HFC-134a Recycling Equipment for Mobile Air Conditioning Systems for certification of MVAC refrigerant handling equipment. SAE has replaced Standard J2210 with J2788, Recovery/Recycle and Recovery/Recycle/Recharging Equipment for HFC-134a Refrigerant. To avoid confusion with an outdated reference, EPA is updating its reference to the new SAE standards. This action reflects a change in industry standard practice. This action also revises the EPA addresses to send equipment certification forms.

This staff accounting bulletin (``SAB'') expresses the views of the staff regarding written loan commitments that are accounted for at fair value through earnings under generally accepted accounting principles. SAB No. 105, Application of Accounting Principles to Loan Commitments (``SAB 105''), provided the views of the staff regarding derivative loan commitments that are accounted for at fair value through earnings pursuant to Statement of Financial Accounting Standards No. 133, Accounting for Derivative Instruments and Hedging Activities. SAB 105 stated that in measuring the fair value of a derivative loan commitment, the staff believed it would be inappropriate to incorporate the expected net future cash flows related to the associated servicing of the loan. This SAB supersedes SAB 105 and expresses the current view of the staff that, consistent with the guidance in Statement of Financial Accounting Standards No. 156, Accounting for Servicing of Financial Assets, and Statement of Financial Accounting Standards No. 159, The Fair Value Option for Financial Assets and Financial Liabilities, the expected net future cash flows related to the associated servicing of the loan should be included in the measurement of all written loan commitments that are accounted for at fair value through earnings. SAB 105 also indicated that the staff believed that internally-developed intangible assets (such as customer relationship intangible assets) should not be recorded as part of the fair value of a derivative loan commitment. This SAB retains that staff view and broadens its application to all written loan commitments that are accounted for at fair value through earnings. The staff expects registrants to apply the views in Question 1 of SAB 109 on a prospective basis to derivative loan commitments issued or modified in fiscal quarters beginning after December 15, 2007.

The Transportation Security Administration (TSA) is altering and re-publishing the complete system of records, DHS/TSA 019, under the Privacy Act of 1974, known as ``Secure Flight Records,'' for a passenger screening program known as Secure Flight. TSA originally established this system of records and published the system of records notice (SORN) in the Federal Register on August 23, 2007 (Part III, 72 FR 48392). TSA received and considered public comments on the SORN and is altering the system of records to reflect the deletion of an exemption previously claimed under 5 U.S.C. 552a(k)(1). The Secure Flight program implements a mandate of the Intelligence Reform and Terrorism Prevention Act of 2004 (IRTPA) and is consistent with TSA's authority under the Aviation and Transportation Security Act (ATSA). Section 4012(a)(1) of the IRTPA requires TSA to assume from air carriers the comparison of passenger information for domestic flights to the consolidated and integrated terrorist watch list maintained by the Federal Government. Further, section 4012(a)(2) of IRTPA similarly requires the DHS to compare passenger information for international flights to and from the United States against the consolidated and integrated terrorist watch list before departure of such flights. The SORN is being altered to reflect TSA's determination that the system will not contain classified material, and TSA will not claim an exemption under 5 U.S.C. 552a(k)(1).

The Commander, Eighth Coast Guard District, has issued a temporary deviation from the regulation governing the operation of the State Route 433 (S433) Bridge across Bonfouca Bayou, mile 7.0, at Slidell, St. Tammany Parish, Louisiana. This deviation will test a change to the drawbridge operation schedule to determine whether a permanent change to the schedule is needed.

This Notice identifies unutilized, underutilized, excess, and surplus Federal property reviewed by HUD for suitability for possible use to assist the homeless.

The Board is amending Regulation Z, which implements the Truth in Lending Act, and the official staff commentary to the regulation, to withdraw portions of the interim final rules for the electronic delivery of disclosures issued March 30, 2001. The 2001 interim final rules addressed the timing and delivery of electronic disclosures, consistent with the requirements of the Electronic Signatures in Global and National Commerce Act (E-Sign Act). Because compliance with the 2001 interim final rules has not been mandatory, withdrawal of these provisions from the Code of Federal Regulations reduces confusion about the status of the provisions and simplifies the regulation. In addition, the Board is adopting final amendments to Regulation Z to provide guidance on the electronic delivery of disclosures. For example, the final rules provide that when an application for a credit card is accessed by a consumer in electronic form, disclosures may be provided to the consumer in electronic form on or with the application without regard to the consumer consent and other provisions of the E- Sign Act. Similar final rules are being adopted under other consumer fair lending and financial services regulations administered by the Board.

The Board is amending Regulation E, which implements the Electronic Fund Transfer Act, and the official staff commentary to the regulation, to withdraw portions of the interim final rules for the electronic delivery of disclosures issued March 30, 2001. The interim final rules addressed the timing and delivery of electronic disclosures, consistent with the requirements of the Electronic Signatures in Global and National Commerce Act (E-Sign Act). Because compliance with the 2001 interim final rules has not been mandatory, withdrawal of these provisions from the Code of Federal Regulations reduces confusion about the status of the provisions and simplifies the regulation. Similar rules are being adopted under other consumer fair lending and financial services regulations administered by the Board.

A recently-enacted federal law directs the Commission to develop rules to implement a new postal ratemaking system. This document responds to that directive by adopting rules addressing market dominant and competitive products, including negotiated service agreements, the regulatory calendar, and product lists. Adoption of the rules allows the Postal Service and mailers to begin to exercise its options under the new law.