August 2006 – Federal Register Recent Federal Regulation Documents

The NRC has recently submitted to OMB for review the following proposal for the collection of information under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). The NRC hereby informs potential respondents that an agency may not conduct or sponsor, and that a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. 1. Type of submission, new, revision, or extension: Revision. 2. The title of the information collection: NRC Form 790, ``Classification Record''. 3. The form number if applicable: NRC Form 790. 4. How often the collection is required: On occasion. 5. Who will be required or asked to report: NRC licensees, contractors, and certificate holder who classify and declassify NRC information. 6. An estimate of the number of annual responses: 300. 7. The estimated number of annual respondents: 1. 8. An estimate of the total number of hours needed annually to complete the requirement or request: 20. 9. An indication of whether Section 3507(d), Pub. L. 104-13 applies: Not applicable. 10. Abstract: Completion of the NRC Form 790 is a mandatory requirement for NRC licensees, contractors, and only certificate holder who classifies and declassifies NRC information in accordance with Executive Order 12958, as amended, ``Classified National Security Information,'' the Atomic Energy Act, and implementing directives. A copy of the final supporting statement may be viewed free of charge at the NRC Public Document Room, One White Flint North, 11555 Rockville Pike, Room O-1 F21, Rockville, MD 20852. OMB clearance requests are available at the NRC worldwide Web site: https:// www.nrc.gov/public-involve/doc-comment/omb/. The document will be available on the NRC home page site for 60 days after the signature date of this notice. Comments and questions should be directed to the OMB reviewer listed below by September 28, 2006. Comments received after this date will be considered if it is practical to do so, but assurance of consideration cannot be given to comments received after this date. OMB Desk Officer, Office of Information and Regulatory Affairs (3150- 0052), NEOB-10202, Office of Management and Budget, Washington, DC 20503. Comments can also be submitted by telephone at (202) 395-3087. The NRC Clearance Officer is Brenda Jo Shelton, 301-415-7233.

Notice is hereby given that the U.S. International Trade Commission is requesting briefing on remedy, the public interest, and bonding with respect to a respondent previously found in default.

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 proposed collection of information that will permit an applicant to certify that it qualifies as a ``small business'' within the meaning of the Medical Device User Fee and Modernization Act (MDUFMA).

In accordance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which provides opportunity for public comment on new or revised data collections, the Railroad Retirement Board (RRB) will publish periodic summaries of proposed data collections. Comments are invited on: (a) Whether the proposed information collection is necessary for the proper performance of the functions of the agency, including whether the information has practical utility; (b) the accuracy of the RRB's estimate of the burden of the collection of the information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden related to the collection of information on respondents, including the use of automated collection techniques or other forms of information technology. Title and purpose of information collection: Voluntary Customer Surveys in Accordance with Executive Order 12862; OMB 3220-0192. In accordance with Executive Order 12862, the Railroad Retirement Board (RRB) conducts a number of customer surveys designed to determine the kinds and quality of services our beneficiaries, claimants, employers and members of the public want and expect, as well as their satisfaction with existing RRB services. The information collected is used by RRB management to monitor customer satisfaction by determining to what extent services are satisfactory and where and to what extent services can be improved. The surveys are limited to data collections that solicit strictly voluntary opinions, and do not collect information which is required or regulated. The information collection, which was first approved by the Office of Management and Budget (OMB) in 1997, provides the RRB with a generic clearance authority. This generic authority allows the RRB to submit a variety of new or revised customer survey instruments (needed to timely implement customer monitoring activities) to the Office of Management and Budget (OMB) for expedited review and approval. The average burden per response for customer satisfaction activities is estimated to range from 2 minutes for a web-site questionnaire to 2 hours for participation in a focus group. The RRB estimates an annual burden of 1,750 annual respondents totaling 717 hours for the generic customer survey clearance. Additional Information or Comments: To request more information or to obtain a copy of the information collection justifications, forms, and/or supporting material, please call the RRB Clearance Officer at (312) 751-3363 or send an e-mail request to Charles.Mierzwa@RRB.GOV. Comments regarding the information collection should be addressed to Ronald J. Hodapp, Railroad Retirement Board, 844 N. Rush Street, Chicago, Illinois 60611-2092 or send an E-mail to Ronald.Hodapp@RRB.GOV. Comments should be received within 60 days of this notice.

The Food and Drug Administration (FDA) is issuing a notice of proposed rulemaking that would establish that over-the-counter (OTC) skin bleaching drug products are not generally recognized as safe and effective (GRASE) and are misbranded. FDA is also withdrawing the previous proposed rule on skin bleaching drug products for OTC human use, which was issued in the form of a tentative final monograph (TFM). FDA is issuing this proposed rule after considering new data and information on the safety of hydroquinone, the only active ingredient that had been proposed for inclusion in a monograph for these products. This proposal is part of FDA's ongoing review of OTC drug products. Further, upon issuance of a final rule, FDA intends to consider all skin bleaching drug products, whether currently marketed on a prescription or OTC basis, to be new drugs requiring an approved new drug application (NDA) for continued marketing.

Our safety standard on occupant protection in interior impact requires, in part, that light vehicles provide head protection when an occupant's head strikes upper interior components, such as pillars, side rails, headers, and the roof during a crash. While these requirements already apply to most vehicles, the compliance date for altered vehicles and vehicles built in two or more stages is September 1, 2006. In April 2006, we responded to two petitions for rulemaking by proposing certain amendments to the head protection requirements as they apply to these vehicles. We also proposed to delay the compliance date of the requirements for these vehicles until September 1, 2008. Given the short period of time until the current September 1, 2006 compliance date, and as a partial step toward completing action on the April 2006 proposal, we are, by this final rule, delaying the compliance date for one year. This will give us time to fully analyze the comments and reach a decision on other aspects of the proposal, including the proposed additional delay in the compliance date.

This final rule revises the Hazardous Materials Regulations to address a known safety problem with cylinders manufactured of aluminum alloy 6351-T6. The revisions include an inspection and testing program for early detection of sustained load cracking on cylinders manufactured of aluminum alloy 6351-T6 and used in self-contained underwater breathing apparatus (SCUBA), self-contained breathing apparatus (SCBA), and oxygen services.

In accordance with section 102(a)(4)(C) of the Department of Housing and Urban Development Reform Act of 1989, this announcement notifies the public of past funding decisions made by the Department in a competition for funding under the 2002, 2003, 2004 and 2005 Notices of Funding Availability (NOFAs) for the Housing Opportunities for Persons with AIDS (HOPWA) program. This announcement contains the names of the awardees and the amounts of the awards made available by HUD in 2002, 2003, 2004 and 2005. Federal Register notices on these actions were not published at the time; however, the public was advised of these grant selections since they were posted on HUD's Web site. The postings contained listings of the selected applicants including descriptions of the projects.

This document contains proposed amendments to the regulations relating to user fees for the special enrollment examination to become an enrolled agent, the application for enrollment of enrolled agents, and the renewal of this enrollment. The charging of user fees is authorized by the Independent Offices Appropriations Act (IOAA) of 1952. This document also contains a notice of public hearing on these proposed regulations.

NOAA and the USFWS are issuing final regulations for the Northwestern Hawaiian Islands Marine National Monument. This action codifies the prohibitions and management measures set forth in Presidential Proclamation 8031 establishing the Monument. The rule is effective immediately.

This solicitation is for proposals from national non-profit organizations with transportation coordination and technical assistance expertise for a cooperative agreement to develop and implement a National Resource Center for Human Service Transportation Coordination (NRC). The NCR will manage a program to improve and enhance the coordination of Federal resources for human service transportation with those of the Department of Transportation (DOT). The major goal of the NRC is to assist local communities and States in the expansion and provision of coordinated human service transportation for older adults, people with disabilities, and individuals with lower incomes. Federal Transit Administration (FTA) will award one four year agreement. Year one of the cooperative agreement is for one million, five hundred eighty-four thousand dollars ($1,584,000) as authorized in the Safe, Accountable, Flexible, and Efficient Transportation Equity ActA Legacy for Users (SAFETEA-LU) and subsequently appropriated. Funding for subsequent years will be based on annual appropriations as well as annual performance reviews.

This notice lists the location and time of the next Charter Bus Negotiated Rulemaking Advisory Committee (CBNRAC) meeting.

This rule prescribes final early-season frameworks from which the States, Puerto Rico, and the Virgin Islands may select season dates, limits, and other options for the 2006-07 migratory bird hunting seasons. Early seasons are those that generally open prior to October 1, and include seasons in Alaska, Hawaii, Puerto Rico, and the Virgin Islands. The effect of this final rule is to facilitate the selection of hunting in seasons by the States and Territories to further the annual establishment of the early-season migratory bird hunting regulations.

The FAA is proposing a rule to address the potential for increased congestion and delay at New York's LaGuardia Airport (LaGuardia) when the High Density Rule (HDR) expires there on January 1, 2007. The rule, if adopted, would establish an operational limit on the number of aircraft landing and taking off at the airport. To offset the effect of this limit, the proposed rule would increase utilization of the airport by encouraging the use of larger aircraft through implementing an airport-wide, average aircraft size requirement designed to increase the number of passengers that may use the airport within the overall proposed operational limits.

This action corrects an error in the airport reference point (ARP) for Provo Municipal Airport, Provo, UT, in the final rule that was published in the Federal Register on August 1, 2006, (71 FR 43355), Docket No. FAA-2006-24234; Airspace Docket No. 06-AWP-5. In addition, corrections are made to change FAA Order 7400.9O to FAA Order 7400.9N, amending its date in two references to September 1, 2005, effective September 15, 2005; and make two editorial changes, replacing the word attends with amends in the Summary, and Class D to Class E in the legal description.

The Food and Drug Administration (FDA) is proposing to amend its regulations governing drug establishment registration and drug listing. The proposed revisions would reorganize, consolidate, clarify, and modify current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products (including vaccines and allergenic products), and/ or human cells, tissues, and cellular and tissue-based products (HCT/ Ps), and animal drugs. The proposal describes when and how to register and list and what information must be submitted for registration and listing. In addition, the proposal would make certain changes to the National Drug Code (NDC) system and would require the appropriate NDC number to appear on the labels for drugs subject to the listing requirements. The proposed regulations generally would require the electronic submission of all registration and most listing information. We (FDA) rely on establishment registration and drug listing information for administering many of our programs, such as postmarketing surveillance (including FDA inspections), bioterrorism, drug shortages and availability, and user fee assessments. We are taking this action to use the latest technology to improve our registration and listing system, which would further our goal of protecting the public health. We also believe that the conversion to an electronic system would make the registration and listing processes more efficient and effective for industry and us. We are also taking this action to support the implementation of, for example, the electronic prescribing provisions of the Medicare Prescription Drug, Improvement, and Modernization Act, our rulemaking requiring a bar code on certain drug products, and the DailyMed initiative.