Notices. Notice

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A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 6715-01-M FEDERAL MARITIME COMMISSION [Docket No. 06-03] Premier Automotive Serices, Inc. v. Robert L. Flanagan and F. Brooks Royster, III; Notice of Filing of Complaint and Assignment Notice is given that a complaint has been filed with the Federal Maritime Commission (“Commission”) by Premier Automotive Services, Inc., (“Complainant”), against Robert L. Flanagan and F. Brooks Royster, III, (“Respondents”). Complainant asserts that it is a Baltimore based import/export vehicle processing center that operates as a marine terminal operator under The Shipping Act of 1984 (“the Act”).

Complainant contends that Respondent Robert L. Flanagan is the Secretary of the Department of Transportation of the State of Maryland and the Chairman of the Maryland Port Commission, and Respondent F. Brooks Royster, III, is the Executive Director of the Maryland Port Administration. Complainant asserts that it has been a tenant of the Maryland Port Authority (“MPA”) since 1992, renewing the lease once in 1998 and then leasing month-to- month since 2002. The Complainant further contends the MPA has demanded that Complainant vacate the premises after refusing to negotiate a commercially reasonable lease.

Complainant alleges that the MPA and its Directors have violated Section 10(d)(1) of the Act (46 U.S.C. App. 1709(d)(1)) by failing to establish, observe, and enforce just and reasonable regulations and practices relating to or connected with receiving, handling, storing, or delivering property. In addition, Complainant alleges that Respondents violated Sections 10(d)(3) of the Act (46 USA App. § 1709(d)(3)) by unreasonably refusing to deal with a tenant, and 10(d)(4) of the Act (46 U.S.C.

App. 1709(d)(4)) by giving undue or unreasonable preference or advantage or imposing undue or unreasonable prejudice or disadvantage with respect to any person. Respondent asserts that the Commission has found that it might have jurisdiction to adjudicate a “* * * privately-initiated complaint proceeding against the directors of a state-run port rather than against the port.” Respondent prays that the Commission: seek a temporary restraining order and preliminary injunction enjoining the Respondents to cease their unlawful treatment of Complainant and from leasing the lot to another company; declare that the Respondents have violated the Act as detailed above and direct the Respondents to cease all such violations; direct Respondents to offer Complainant a commercially viable lease for the lot in question; award Complainant reparations for actual injuries, pre and post-judgment interest, and litigation and attorney fees; and award such other and further relief as deemed just and proper.

This proceeding has been assigned to the Office of Administrative Law Judges. Hearing in this matter, if any is held, shall commence within the time limitations prescribed in 46 CFR 502.61, and only after consideration has been given by the parties and the presiding officer to the use of alternative forms of dispute resolution. The hearing shall include oral testimony and cross-examination in the discretion of the presiding officer only upon proper showing that there are genuine issues of material fact that cannot be resolved on the basis of sworn statements, affidavits, depositions, or other documents or that the nature of the matter in issue is such that an oral hearing and cross-examination are necessary for the development of an adequate record.

Pursuant to the further terms of 46 CFR 502.61, the initial decision of the presiding officer in this proceeding shall be issued by January 31, 2007, and the final decision of the Commission shall be issued by May 31, 2007. Bryant L. VanBrakle, Secretary. [FR Doc. E6-1589 Filed 2-3-06; 8:45 am] BILLING CODE 6730-01-P GENERAL SERVICES ADMINISTRATION Office of Small Business Utilization; Small Business Advisory Committee; Notification of a Public Meeting of the Small Business Advisory Committee AGENCY:

Office of Small Business Utilization, GSA. ACTION: Notice. SUMMARY: The General Services Administration

(GSA)is announcing a public meeting of the GSA Small Business Advisory Committee (the Committee). DATES: The meeting will take place February 21-22. The meeting will begin 1 p.m. Tuesday February 21 and conclude no later than 5 p.m. that day. The meeting will resume 9 a.m. Wednesday February 22 and conclude no later than 3 p.m. that day. The Committee will accept oral public comments at this meeting and has reserved a total of sixty minutes for this purpose. Members of the public wishing to reserve speaking time must contact Denis Peck in writing at: *denis.peck@gsa.gov* or by fax at

(202)208-5938, no later than one week prior to the meeting. ADDRESS: GSA Central Office Auditorium, 1800 F Street, NW., Washington, DC 20405. FOR FURTHER INFORMATION CONTACT: Denis Peck, Room 6021, GSA Building, 1800 F Street, NW., Washington, DC 20405

(202)501-1021 or e-mail at *denis.peck@gsa.gov.* SUPPLEMENTARY INFORMATION: This notice is published in accordance with the provisions of the Federal Advisory Committee Act

(FACA)(Pub. L. 92-463). Background: The purpose of this meeting is to develop the topics generated during the previous meeting September 1, 2005; to receive briefings from small business topical experts, and to hear from interested members of the public on proposals to improve GSA's small business contracting performance. Dated: January 13, 2006. Felipe Mendoza, Associate Administrator, Office of Small Business Utilization, General Services Administration. [FR Doc. E6-1525 Filed 2-3-06; 8:45 am] BILLING CODE 6820-34-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Advisory Committee on Childhood Lead Poisoning Prevention In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the National Center for Environmental Health

(NCEH)of the Centers for Disease Control and Prevention

(CDC)announces the following committee meeting. *Name:* Advisory Committee on Childhood Lead Poisoning Prevention (ACCLPP). *Times and Dates:* 8:30 a.m.-5 p.m., March 21, 2006. 8:30 a.m.-12:30 p.m., March 22, 2006. *Place:* Magnolia Hotel, 1100 Texas Avenue, Houston, Texas 77002. *Telephone:* (281)657-2664 or toll free 1-888-915-1110. *Status:* Open to the public, limited only by the space available. The meeting room accommodates approximately 75 people. *Purpose:* The committee shall provide advice and guidance to the Secretary, Department of Health and Human Services; the Assistant Secretary for Health; and the Director, CDC, regarding new scientific knowledge and technological developments and their practical implications for childhood lead poisoning prevention efforts. The committee shall also review and report regularly on childhood lead poisoning prevention practices and recommend improvements in national childhood lead poisoning prevention efforts. *Matters to be Discussed:* Update on the Primary Prevention Workgroup document; update on the Adverse Health Effects of Blood Lead Levels less than 10 Report; update from the Lead and Pregnancy Workgroup; update of strategic planning process by state and local childhood lead poisoning prevention programs; update on cooperation with the U.S. Department of Housing and Urban Development and the U.S. Environmental Protection Agency enforcement of the Lead Disclosure Rule; and an update on research and program evaluation activities ongoing in the Lead Poisoning Prevention Branch. Agenda items are subject to change as priorities dictate. Opportunities will be provided during the meeting for oral comments. Depending on the time available and the number of requests, it may be necessary to limit the time of each presenter. *Contact Person For More Information:* Claudine Johnson, Lead Poisoning Prevention Branch, Division of Emergency and Environmental Health Services, NCEH, CDC, 4770 Buford Hwy, NE., M/S F-40, Atlanta, Georgia 30341, telephone

(770)488-3629, fax

(770)488-3625. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: January 30, 2006. Diane Allen, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E6-1557 Filed 2-3-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Guide to Community Preventive Services Task Force *Name:* Task Force on Community Preventive Services. *Times and Dates:* 8 a.m.-7 p.m., February 15, 2006; 9 a.m.-1:30 p.m., February 16, 2006. *Place:* Centers for Disease Control and Prevention (CDC), Roybal Campus, Building 19, Room 232 (Auditorium B), 1600 Clifton Road, Atlanta, Georgia 30333, telephone

(404)639-3311. *Status:* Open to the public, limited only by the space available. *Purpose:* The mission of the Task Force is to develop and publish the Guide to Community Preventive Services (GCPS), which is based on the best available scientific evidence and current expertise regarding essential public health and what works in the delivery of those services. *Matters To Be Discussed:*

(1)Briefings on administrative information;

(2)Violence prevention;

(3)Enhanced enforcement of laws prohibiting sale of alcohol to minors;

(4)Worksite health promotion and the assessment of health risks with feedback;

(5)Update on worksite setting and obesity;

(6)Adolescent health;

(7)Provider reminders and provider incentives for cancer screening; and

(8)Dissemination activities and projects in which the Community Guide is utilized. Agenda items are subject to change as priorities dictate. Persons interested in reserving a space for this meeting should call

(770)488-8376 by close of business on February 10, 2006. *Contact Person or Additional Information:* Peter Briss, M.D., Chief, Community Guide Branch, Coordinating Center for Health Information and Service, National Center for Health Marketing, Division of Scientific Communications, 4770 Buford Highway, M/S K-95, Atlanta, Georgia 30333, telephone

(770)488-8338. The Director, Management Analysis and Services Office has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: January 30, 2006. Diane Allen, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E6-1556 Filed 2-3-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Institute for Occupational Safety and Health, Safety and Occupational Health Study Section In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention

(CDC)announces the following committee meeting. *Name:* Safety and Occupational Health Study Section (SOHSS), National Institute for Occupational Safety and Health (NIOSH). *Times and Dates:* 8 a.m.-5 p.m., February 21, 2006. 8:30 a.m.-5 p.m., February 22, 2006. *Place:* Embassy Suites Hotel, 1900 Diagonal Road, Alexandria, Virginia 22314, telephone 703-684-5900, fax 703-684-1403. *Status:* Open 8 a.m.-8:30 a.m., February 21, 2006. Closed 8:30 a.m.-5 p.m., February 21, 2006. Closed 8:30 a.m.-5 p.m., February 22, 2006. *Purpose:* The SOHSS will review, discuss, and evaluate grant application(s) received in response to the Institute's standard grants review and funding cycles pertaining to research issues in occupational safety and health, and allied areas. It is the intent of NIOSH to support broad-based research endeavors in keeping with the Institute's program goals. This will lead to improved understanding and appreciation for the magnitude of the aggregate health burden associated with occupational injuries and illnesses, as well as to support more focused research projects, which will lead to improvements in the delivery of occupational safety and health services, and the prevention of work-related injury and illness. It is anticipated that research funded will promote these program goals. *Matters to be Discussed:* The meeting will convene in open session from 8-8:30 a.m. on February 21, 2006, to address matters related to the conduct of study section business. The remainder of the meeting will proceed in closed session. The purpose of the closed session is for the study section to consider safety and occupational health-related grant applications. These portions of the meeting will be closed to the public in accordance with provisions set forth in section 552b(c)(4) and (6), Title 5 U.S.C., and the determination of the Director, Management Analysis and Services Office, CDC, pursuant to section 10(d), Public Law 92-463. Agenda items are subject to change as priorities dictate. FOR FURTHER INFORMATION CONTACT: Price Connor, Ph.D., NIOSH Health Scientist, 1600 Clifton Road, NE., Mailstop E-20, Atlanta, Georgia 30333, telephone 404-498-2511, fax 404-498-2569. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: January 29, 2006. Diane Allen, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E6-1559 Filed 2-3-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0038] Agency Information Collection Activities; Proposed Collection; Comment Request; Irradiation in the Production, Processing, and Handling of Food AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: 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 reporting and recordkeeping requirements for food irradiation processors. DATES: Submit written or electronic comments on the collection of information by April 7, 2006. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.fda.gov/dockets/ecomments.* Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget

(OMB)for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics:

(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;

(2)the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(3)ways to enhance the quality, utility, and clarity of the information to be collected; and

(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Irradiation in the Production, Processing, and Handling of Food—21 CFR Part 179 (OMB Control Number 0910-0186)—Extension Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(s) and 348), food irradiation is subject to regulation under the food additive premarket approval provisions of the act. The regulations providing for uses of irradiation in the production, processing, and handling of food are found in part 179 (21 CFR part 179). To ensure safe use of a radiation source, § 179.21(b)(1) requires that the label of sources bear appropriate and accurate information identifying the source of radiation and the maximum energy of radiation emitted by x ray tube sources. Section 179.21(b)(2)(i) requires that the label or accompanying labeling bear adequate directions for installation and use. Section 179.25(e) requires that food processors who treat food with radiation make and retain, for 1 year past the expected shelf life of the products up to a maximum of 3 years, specified records relating to the irradiation process (e.g., the food treated, lot identification, scheduled process, etc.). The records required by § 179.25(e) are used by FDA inspectors to assess compliance with the regulation that establishes limits within which radiation may be safely used to treat food. The agency cannot ensure safe use without a method to assess compliance with the dose limits, and there are no practicable methods for analyzing most foods to determine whether they have been treated with ionizing radiation and are within the limitations set forth in part 179. Records inspection is the only way to determine whether firms are complying with the regulations for treatment of foods with ionizing radiation. FDA estimates the burden of this collection of information as follows: ** Table 1.—Estimated Annual Recordkeeping Burden 1 ** 21 CFR Section No. of recordkeepers Annual frequency per recordkeeping Total annual records Hours per record Total hours 179.25(e) 6 120 720 1 720 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The number of firms who process food using irradiation is extremely limited. FDA estimates that there are two irradiation plants whose business is devoted primarily (i.e., approximately 100 percent) to irradiation of food and other agricultural products. Four other firms also irradiate small quantities of food. FDA estimates that this irradiation accounts for no more than 10 percent of the business for each of these firms. Therefore, the average estimated burden is based on: Two facilities devoting 100 percent of their business (or 600 hours for recordkeeping annually) to food irradiation; four facilities devoting 10 percent of their business or 120 hours (4 x 30 hours) for recordkeeping annually to food irradiation. No burden has been estimated for the labeling requirements in §§ 179.21(b)(2)(i) and (b)(2)(ii) and 179.26(c) because the information to be disclosed is information that has been supplied by FDA. Under 5 CFR 1320.3(c)(2), the public disclosure of information originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public is not a collection of information. Dated: January 30, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-1516 Filed 2-3-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0037] Agency Information Collection Activities; Proposed Collection; Comment Request; Proposed Experimental Study of Trans Fat Claims on Foods AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: 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 reinstatement of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed experimental study of *trans* fat claims on foods to evaluate the effects of various possible disclosure requirements intended to help consumers understand and apply *trans* fat claims they might see on food products. The proposed experimental study will estimate the communication effectiveness of these disclosure requirements in realistic label usage situations for a range of products that may bear *trans* fat claims. DATES: Submit written or electronic comments on the collection of information by April 7, 2006. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.fda.gov/dockets/ecomments* . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget

(OMB)for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the **Federal Register** concerning each proposed collection of information, including each proposed reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics:

(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;

(2)the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(3)ways to enhance the quality, utility, and clarity of the information to be collected; and

(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Proposed Experimental Study of Trans Fat Claims on Foods (OMB Control Number 0910-0533)—Reinstatement FDA is requesting OMB approval of a proposed experimental study of *trans* fat claims on food products intended to help FDA's Center for Food Safety and Applied Nutrition formulate decisions and policies affecting labeling requirements for *trans* fat claims on foods. In the **Federal Register** of July 11, 2003 (68 FR 41507), FDA issued an advance notice of proposed rulemaking entitled “Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer Research to Consider Nutrient Content and Health Claims and Possible Footnote or Disclosure Statements,” which requested comments about possible disclosure requirements to accompany nutrient content claims about *trans* fatty acids that could help consumers make heart-healthy food choices. The proposed experimental study will evaluate the ability of several such disclosure requirements to help consumers make heart-healthy food choices. The results of the proposed experimental study will provide empirical support for possible policy decisions about the need for such disclosures and the appropriate form they should take. FDA or its contractor will collect and use information gathered from Internet panel samples to evaluate how consumers understand and respond to possible disclosure requirements for *trans* fat content claims. The distinctive features of Internet panel and shopping mall methodologies for the purpose of the proposed experimental study are that they allow for controlled visual presentation of study materials, experimental manipulation of study materials, and the random assignment of subjects to condition. Experimental manipulation of labels and random assignment to condition makes it possible to estimate the effects of the various possible disclosure requirements while controlling for individual differences. Random assignment ensures that mean differences between conditions can be tested using well-known techniques such as analysis of variance or regression analysis to yield statistically valid estimates of treatment effect size. The proposed study will be conducted from a sample drawn from a large, nationally representative consumer panel with 800,000 households. The sample size and population pool are adequate to ensure that results can be generalized. Participants will be adults, age 18 and older, who are recruited for a study about foods and food labels. Each participant will be randomly assigned to one of the 144 experimental conditions consisting of fully crossing 8 disclosure conditions, 3 product types, 3 fatty acid profiles and 2 prior knowledge conditions. FDA will use the information from the proposed experimental study to evaluate regulatory policy options. The agency often lacks empirical data about how consumers understand and respond to statements they might see in product labeling. The information gathered from this proposed experimental study will be used by the agency to assess likely consumer responses to various disclosure requirements for nutrient content claims. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 Type of survey Number of respondents Annual frequency per response Total annual responses Hours per response Total hours Internet Survey 2880 1 2880 .25 720 Total 720 1 There are no capital costs or operating and maintenance costs associated with this collection of information. FDA's burden estimate is based on prior experience with Internet panel experiments similar to the study proposed here. Dated: January 30, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-1517 Filed 2-3-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N-0317] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a collection of information entitled “Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim” has been approved by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: In the **Federal Register** of November 15, 2005 (FR 70 69344), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0428. The approval expires on January 31, 2009. A copy of the supporting statement for this information collection is available on the Internet at *http://www.fda.gov/ohrms/dockets* . Dated: January 30, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-1518 Filed 2-3-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2000N-1269] (formerly Docket No. 00N-1269) Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Requirements on Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Prescription Drug Product Labels AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a collection of information entitled “Requirements on Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Prescription Drug Product Labels” has been approved by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Karen Nelson, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1482. SUPPLEMENTARY INFORMATION: In the **Federal Register** of December 22, 2000 (65 FR 81082), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0572. The approval expires on January 31, 2009. A copy of the supporting statement for this information collection is available on the Internet at *http://www.fda.gov/ohrms/dockets* . Dated: January 30, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-1519 Filed 2-3-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0029] Agency Information Collection Activities; Proposed Collection; Comment Request; Impact of Coupons on Consumer Perceptions of Products in Prescription Drugs in Direct-to-Consumer Prescription Drug Print Advertisements AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing an opportunity for public comment on a 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a study of the impact of coupons (such as price incentives or rebate offers) on consumers' perceptions of product risks and benefits in direct-to-consumer

(DTC)print ads. DATES: Submit written or electronic comments on the collection of information by April 7, 2006. ADDRESSES: Submit electric comments on the collection of information to: *http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm* . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Karen Nelson, Office Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1482. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget

(OMB)for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collections of information set forth in this document. With respect to each of the following collections of information, FDA invites comments on:

(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;

(2)the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(3)ways to enhance the quality, utility, and clarity of the information to be collected; and

(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Impact of Coupons on Consumer Perceptions of Products in Direct-to-Consumer Prescription Drug Print Advertisements The Federal Food, Drug, and Cosmetic Act (the act) requires that manufacturers, packers, and distributors (sponsors) who advertise prescription human and animal drugs, including biological products for humans, disclose in advertisements certain information about the advertised product's uses and risks. For prescription drugs and biologics, the act requires advertisements to contain “information in brief summary relating to side effects, contraindications, and effectiveness” (21 U.S.C. 352(n)). FDA is responsible for enforcing the act and implementing regulations. FDA regulations require that prescription drug advertisements that make claims about a product must also include risk information in a “balanced” manner (21 CFR 202.1(e)(5)(ii)), both in terms of the content and presentation of the information. Advertisements that draw attention to the name of the product but do not make representations about the product's indication(s) or dosage recommendations are called reminder advertisements. Reminder ads may mention the proprietary and established name of the product and (optionally) contain information about the product's ingredients, dosage form, quantity, price, or manufacturer (21 CFR 202.1(e)(2)(i)). Graphic presentation and information is not prohibited in reminder ads as long as that information does not make a representation or suggestion about the product beyond those permitted. The exemption for reminder ads was originally intended to allow distribution of price sheets, pens, notepads and other minor giveaways featuring the name of the drug product to physicians and other healthcare professionals without requiring a full disclosure of the product's risks. As DTC promotion has increased, sponsors have chosen to create reminder ads for consumers. Sponsors may use ads as a vehicle to offer price incentives or coupons to consumers (e.g., “free trial,” “buy six get one free”). Coupon promotions are widely used in many product categories and have been the topic of many academic studies. Coupons are primarily offered to increase the sales of the brand relative to their level without coupons. 1 Certain types of coupons, most notably those that appear in the body of an advertisement itself, can positively impact perceptions of the brand. 1 LeClerc, France and John D.C. Little “Can advertising copy make FSI coupons more effective?” *Journal of Marketing Research* , 34(4), 473-484, 1997. People tend to rate owned objects more favorably than those they do not own, even when those objects have been assigned to them at random. 2 This has been termed the “mere ownership” or “mere possession” effect. An interesting extension of this effect is provided in research by Sen and Johnson 3 which has shown that consumers rate a product more favorably when they are simply given a gift certificate or a coupon for that product or service. Other research has examined the effect of warranties. People who viewed an ad with a high warranty perceived the product as being less risky compared to people who saw an ad with a medium or low warranty. 4 2 Beggan, James K., “On the social nature of nonsocial perception: The mere ownership effect,” *Journal of Personality and Social Psychology* , 62(2), 229-237, 1992. 3 Sen, Sankar and Eric J. Johnson, “Mere-possession effects without possession in consumer choice,” *Journal of Consumer Research* , 24 (June), 105-117, 1997. 4 Shimp, Terrence A. and William O. Bearden, “Warranty and other extrinsic cue effects on consumers' risk perceptions,” *Journal of Consumer Research* , 9 (June), 38-47, 1982. Based on this body of consumer research, the inclusion of coupons or other price incentives in DTC ads may impact consumers' perceptions of the risks and benefits of the prescription drug. For “simple” consumer products, coupons and free trial offers may enable the customer to test new products while minimizing their financial risk of testing the product. For products that consumers can readily test and ones where performance can be adequately verified (termed “search” goods by economists), coupons and free trial offers provide both the consumer and manufacturer an efficient mechanism for matching consumers and products. For more complex products such as prescription drugs where supervision of a physician is required to evaluate both appropriateness and performance, coupons and free trial offers may send different signals. These signals may foster consumer misperceptions about the advertised prescription drug product by exploiting general beliefs. Thus, prescription drugs promoted with coupons or free trial offers may be seen as more widely indicated, more appropriate and/or less risky than they really are. Inclusion of a mechanism that affects consumers' perception of the product's risks is especially problematic in reminder ads because this type of ad contains no accompanying risk information. Furthermore, coupons and price promotions may imply superior drug efficacy. The proposed study will examine the impact coupons have on consumers' perceptions of risks and benefits and the overall impression of the product in DTC full-product and reminder advertisements. To justify future regulatory changes, we need to have better empirical data about consumers' perceptions of the information in both types of ads and how inclusion of such promotional devices can impact consumers' perceptions of the risks and benefits of advertised prescription drugs. *Design Overview* : This study will employ a between-subjects crossed factorial design and will focus on consumer print advertising. Fifteen print advertisements will be created using three levels of ad type and five levels of promotional offer. Thus, the factors will be ad type (DTC print reminder; DTC print full product; over-the-counter print full product) and offer type (free trial offer; buy one, get one free; money off prescription/purchase cost; money back guarantee; no promotion). Product name and indication will be constant across conditions. Side effect and risk information will be constant across full product DTC ad conditions. Participants will be asked to read a single print advertisement for a new drug. After reading the advertisement, they will be asked questions about their evaluation of the information presented in the advertisement. *Factors* : ( *1* ) *Participants* . Consumers will be screened and recruited by the contractor to be currently diagnosed with insomnia or at risk of developing insomnia. Participants will be randomly assigned to experimental cells. Each condition will be balanced with respect to gender. Because this is the first investigation of this issue with DTC ads, we chose to limit our investigation to one disease condition. We chose to accept this decrease in generality to maximize our ability to detect a subtle difference between promotion types. Participants will be screened to represent a range of education levels (some college or less vs. completed college or more). Because the task presumes basic reading abilities, all participants will have English as their primary language and, as appropriate, be required to have reading glasses when participating in the study. ( *2* ) *Type of Ad* . Three types of ads will be tested: A full-product ad for a prescription drug, a reminder ad for a prescription drug, and an ad for an over-the-counter

(OTC)drug. An ad for an OTC drug, which typically includes benefit but not risk information, is included to see if prior research findings in the area of consumer package goods can be replicated. It is expected that consumer processing of information in the ad may vary by presence of a promotion. For instance, consumers may assign more weight to benefit claims in cases where a promotional coupon is included. ( *3* ) *Type of Promotion* . Five types of promotion will be tested: Free trial offer, buy one, get one free, money-off prescription/purchase cost, money back guarantee, and a no promotion condition. With the exception of buy one, get one free, these are promotional variations that have been used in drug advertising. We ask for comment on other promotional types that could be tested. *Procedure* : Participants will be shown one ad, for example, a reminder ad for a prescription drug with a free-trial offer coupon attached. Then the participant will be asked to answer questions examining a number of important perceptions about the product, including perceived riskiness of the drug, likelihood of benefits, and behavioral intent (talking to doctor, product purchase). Finally, demographic and health care utilization information will be collected. Interviews are expected to last approximately 15 minutes. A total of 1,350 participants will be involved. This will be a one time (rather than annual) collection of information. FDA estimates the burden of this collection of information as follows: FDA estimates that 2,025 individuals will need to be screened to obtain a respondent sample of 1,350. The screener is expected to take 30 seconds, for a total screener burden of 17 hours. The 1,350 respondents will then be asked to respond to a series of questions about the advertisement. We estimate the response burden for the consumer part of the survey to be 15 minutes, for a burden of 337.5 hours. The estimated total burden for this data collection effort is 354.5 hours. The respondent burden chart is listed below: Estimated Annual Reporting Burden No. of respondents Annual frequency per response Total annual responses Hours per response Total hours 2,025 (screener) 1 2,025 .008 17 1,350 (questionnaire) 1 1,350 .25 337.5 Total 3,375 354.5 Footnote: there are no capital costs or operating and maintenance costs associated with this data collection. Dated: January 30, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-1521 Filed 2-3-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0036] Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosure on the Nutrition Facts Panel AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: 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 reinstatement of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on an experimental study of possible footnotes and cueing schemes intended to help consumers understand and apply quantitative *trans* fat information they might see on the Nutrition Facts Panel of a food product. The experimental study will estimate the communication effectiveness of quantitative *trans* fat information in terms of its ability to help consumers make heart-healthy product decisions in realistic label usage situations for a range of products. DATES: Submit written or electronic comments on the collection of information by April 7, 2006. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.fda.gov/dockets/ecomments* . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget

(OMB)for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the **Federal Register** concerning each proposed collection of information, including each proposed reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics:

(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;

(2)The accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(3)Ways to enhance the quality, utility, and clarity of the information to be collected; and

(4)Ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosure on the Nutrition Facts Panel (OMB Control Number 0910-0532)—Reinstatement FDA is requesting OMB approval of an experimental study of possible footnotes and cueing schemes intended to help consumers interpret quantitative *trans* fat information on the Nutrition Facts Panel of a food product. The purpose of the experimental study is to help FDA's Center for Food Safety and Applied Nutrition formulate decisions and policies affecting labeling requirements for *trans* fat disclosure. In the **Federal Register** of July 11, 2003 (68 FR 41434), FDA issued a final rule requiring disclosure on the Nutrition Facts Panel of quantitative *trans* fat information on a separate line without any accompanying footnote. At the same time, the agency issued an advance notice of proposed rulemaking entitled, “Food Labeling: *Trans* Fatty Acids in Nutrition Labeling; Consumer Research to Consider Nutrient Content and Health Claims and Possible Footnote or Disclosure Statements,” (68 FR 41507) which requested comments about possible footnotes to help consumers better understand *trans* fat declarations on the product label. The agency sought comments about whether it should consider requiring statements about *trans* fat, either alone or in combination with saturated fat and cholesterol, as a footnote on the Nutrition Facts Panel to enhance consumers' understanding about such cholesterol-raising lipids and how to use information on the label to make healthy food choices. Comments received in response to the notice contained suggested footnotes and cueing schemes. The proposed experimental study will evaluate the ability of several possible footnotes and cueing schemes to help consumers make heart-healthy food choices. The results of the experimental study will provide empirical support for possible policy decisions about the need for such requirements and the appropriate form they should take. FDA or its contractor will use information gathered from Internet panel samples to evaluate how consumers understand and respond to possible footnote and cueing schemes. The distinctive features of Internet panels for the purpose of the experimental study are that they allow for controlled visual presentation of study materials, experimental manipulation of study materials, and the random assignment of subjects to condition. Experimental manipulation of labels and random assignment to condition makes it possible to estimate the effects of the various possible footnotes and cueing schemes while controlling for individual differences between subjects. Random assignment ensures that mean differences between conditions can be tested using well-known techniques such as analysis of variance or regression analysis to yield statistically valid estimates of effect size. The study will be conducted from a sample drawn from a large, nationally representative consumer panel with 800,000 households. The sample size and population pool are adequate to ensure that results can be generalized. Participants will be adults, age 18 and older, who are recruited for a study about foods and food labels. Each participant will be randomly assigned to one of the 42 experimental conditions derived from fully crossing 7 possible footnotes/cueing schemes, 3 product types, and 2 prior knowledge conditions. FDA will use the information from the experimental study to evaluate regulatory and policy options. The agency often lacks empirical data about how consumers understand and respond to statements they might see in product labeling. The information gathered from this experimental study will be used to estimate consumer comprehension and the behavioral impact of various footnotes and cueing schemes intended to help consumers better understand quantitative *trans* fat information. The experimental study data will be collected using participants of an Internet panel of approximately 600,000 people. Participation in the experimental study is voluntary. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 Type of survey No. of respondents Annual frequency per response Total annual responses Hours per response Total hours Internet survey 3,240 1 3,240 .25 810 Total 810 1 There are no capital costs or operating and maintenance costs associated with this collection of information. FDA's burden estimate is based on prior experience with Internet panel experiments similar to the study proposed in this document. Dated: January 30, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-1522 Filed 2-3-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0032] Referral of ZINECARD (dexrazoxane) and RELPAX (eletriptan) Written Requests for the Conduct of Pediatric Studies AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the referral of ZINECARD (dexrazoxane) and RELPAX (eletriptan) Written Requests for the conduct of pediatric studies to the Foundation for the National Institutes of Health (the Foundation). FDA referred the ZINECARD (dexrazoxane) and RELPAX (eletriptan) Written Requests to the Foundation on August 29, 2005, and is publishing this notice of the referrals in accordance with the Best Pharmaceuticals for Children Act (BPCA). FOR FURTHER INFORMATION CONTACT: Grace Carmouze, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, rm. 1613, Silver Spring, MD 20993-0002, 301-796-2200, e-mail: *carmouzeg@cder.fda.gov.* SUPPLEMENTARY INFORMATION: In accordance with section 4 of the BPCA (Public Law 107-109), FDA is announcing the referral to the Foundation of the written requests for the conduct of pediatric studies for ZINECARD (dexrazoxane) and RELPAX (eletriptan). Enacted on January 4, 2002, the BPCA reauthorizes, with certain important changes, the exclusivity incentive program described in section 505A of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355a). Section 505A of the act permits certain applications to obtain 6 months of exclusivity if, in accordance with the requirements of the statute, the sponsor submits requested information relating to the use of the drug in the pediatric population. The BPCA established additional mechanisms for obtaining information on the safe and effective use of drugs in pediatric patients. Specifically, section 4 of the BPCA amends section 505A(d) of the act to create a referral process to obtain studies for drugs that have patent or exclusivity protection, but for which the sponsor has declined to conduct the pediatric studies in response to a written request by FDA. Under section 4 of the BPCA, if the Secretary of Health and Human Services (the Secretary) determines that there is a continuing need for the pediatric studies described in the written request and the sponsors of the products with patent or exclusivity protection have declined to conduct the studies, the Secretary shall refer the drug to the Foundation, established under section 499 of the Public Health Service Act (42 U.S.C. 290(b)), for the conduct of the pediatric studies described in the written request (21 U.S.C. 355a(d)(4)(B)(i)). In addition, the BPCA requires public notice of the name of the drug, name of the manufacturer, and indications to be studied under the referrals (21 U.S.C. 355a(d)(4)(B)(ii)). In accordance with section 4 of the BPCA, FDA is announcing that on August 29, 2005, it referred to the Foundation the written requests for pediatric studies for ZINECARD (dexrazoxane) and RELPAX (eletriptan). On July 14, 2004, FDA issued a written request for pediatric studies to Pfizer, Inc., the holder of approved applications for RELPAX (eletriptan) that have market exclusivity. The studies described in the written request were for the acute treatment of migraines in adolescents. Pfizer, Inc., declined to conduct the requested studies. FDA has determined that there is a continuing need for information relating to the use of RELPAX (eletriptan) in the pediatric population. On June 17, 2004, FDA issued a written request for pediatric studies to Pfizer, Inc., the holder of approved applications for ZINECARD (dexrazoxane) that have market exclusivity. The studies described in the written request were for cardioprotection in children receiving doxorubicin therapy. Pfizer, Inc., declined to conduct the requested studies. FDA has determined that there is a continuing need for information relating to the use of ZINECARD (dexrazoxane) in the pediatric population. Dated: January 27, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-1520 Filed 2-3-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Proposed Collection; Comment Request In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer on

(240)276-1243. Comments are invited on:

(a)Whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;

(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;

(c)ways to enhance the quality, utility, and clarity of the information to be collected; and

(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Proposed Project: Social Network Analysis of a Service System for Transition Aged Youth—New SAMHSA's, Center for Mental Health Services will seek information about the change in the network of social services in one community, Clark County Washington, as a result of a Center for Mental Health Services funded grant initiative, the Options Program. The Options program was one of 5 funded sites across the country. Each site received four years of funding to build comprehensive supports that help adolescents with serious emotional disturbance and their families make the difficult transition from adolescent to adult functioning through the age of 25. This grant program, called the Partnerships for Youth Transition, aims to remediate some of the most difficult system barriers that interfere with transition system building by providing community leaders and advocates funding for direct services and infrastructure building, technical assistance to help shape the vision, and time to establish programs and interagency relationships. Since no single site in the country has ever successfully built a transition support system we do not know whether combining the resources of this grant, with the resources of the community are sufficient to make significant strides in transition system building. It is imperative to answer this question systematically and rigorously in order to guide future efforts. There have been 110 agencies identified in Clark County that could potentially serve youth or young adults with serious mental, emotional and behavioral disorders. This study will conduct network analysis by interviewing one key informant from each of these programs about their organization's professional relationship with other social services. The Social Network Questionnaire was previously developed for use in several studies in mental health and homeless services. Questions focus on aspects of professional relationship such as how often clients are referred to another agency and how often staff meet for client planning purposes with staff from another agency, as well as some background information about the agency and the quality of services offered. An additional 10 items focus on whether the program is following guidelines for exemplary practice with transition aged youth. Findings will be compared to data collected prior to program initiation. The following table summarizes the estimated response burden for this project. Respondent Number of respondents Responses/ respondent Total responses Hours per response Total hour burden Key informants from social services in Clark County 110 1 110 1.25 137.5 Send comments to Summer King, SAMHSA Reports Clearance Officer, Room 7-1044, One Choke Cherry Road, Rockville, MD 20857. Written comments should be received within 60 days of this notice. Dated: January 27, 2006. Anna Marsh, Executive Officer, SAMHSA. [FR Doc. E6-1561 Filed 2-3-06; 8:45 am] BILLING CODE 4162-20-P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Federal Emergency Management Agency, Department of Homeland Security. ACTION: Notice and request for comments. SUMMARY: The Federal Emergency Management Agency, 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 proposed revision of a currently approved information collection. In accordance with the Paperwork Reduction Act of 1995, this notice seeks comments concerning the National Urban Search and Rescue (US&R) grant program. SUPPLEMENTARY INFORMATION: Section 303 of the Robert T. Stafford Disaster Relief and Emergency Assistance Act (Stafford Act), 42 U.S.C. 5144, authorizes the President of the United States to form emergency Support teams of Federal personnel to be deployed in an area affected by a major disaster or emergency. Under Section 403(a)(3)(B) of the Stafford Act provides that the President may authorize Federal agencies to perform work on public or private lands essential to save lives and protect property, including search and rescue and emergency medical care, and other essential needs. FEMA established the National Urban Search and Rescue Response System (US&R) under these authorities. The President amended E.O. 121448 to transfer the FEMA Director's delegated authority to the Secretary of Homeland Security. Collection of Information *Title:* National Urban Search and Rescue Program Agreement, Application, Reporting, and Audit Requirement. *Type of Information Collection:* Revision of a currently approved collection. *OMB Number:* 1660-0073. *Form Numbers:* None. *Abstract:* The information collection activity is the collection of financial, program and administrative information for US&R Sponsoring Organizations relating to preparedness and response grant awards. This information includes a narrative statement that FEMA uses to evaluate a grantee's proposed use of funds, progress reports to monitor overall progress on managing FEMA grant program, extension or change requests used to consider changing or extending the time or the performance period of the preparedness or response cooperative agreement and a memorandum of agreement between DHS/FEMA and the Sponsoring Organizations of US&R task forces as described below. *Narrative Statement:* FEMA uses narrative statements to evaluate a grantee's proposed use of funds. Examples of information a grantee needs to provide FEMA for preparedness and response cooperative agreements are a description of the types of eligible activities the grantee will undertake, a plan for expending and monitoring funds, and an estimate of the percentage or amount of funds the grantee will pass through to sub-grantees. Sponsoring Organizations make this information available to FEMA only when we request it. If a Sponsoring Organization has remaining preparedness or response cooperation agreement funds after completing specific disaster or preparedness work, we will require a second narrative statement describing the grantee's proposed use of the remaining funds. *Progress Reports:* FEMA program officers use progress reports to monitor overall progress on managing FEMA grant programs. We do not prescribe a particular format; however, we ensure that the OMB standard elements outlined in the common rule, 44 CFR part 13, are in any report or suggested format. *Extension or Change Requests:* Grantees that want FEMA to consider changing or extending the time or the performance period of the preparedness or response cooperative agreement will need to request such changes or extensions in writing. FEMA will use the information to ensure that the Sponsoring Organization spends funds consistent with the intent of the appropriations an in accordance with applicable laws and guidance. This type of information is available to FEMA only when we request it. *Affected Public:* State, local, or tribal government. *Estimated Total Annual Burden Hours:* **Annual Burden Hours** Project/activity (survey, form(s), focus group, etc.) No. of respondents

(A)Frequency of responses

(B)Burden hours per respondent

(C)Annual responses (A × B) Total annual burden hours (A × B × C) Narrative Statement 28 2 4 56 224 Progress Reports 28 2 2 56 112 Extension or Change Requests 5 1 1 5 5 Memorandum of Agreements 28 1 4 28 112 Total 28 11 229 453 *Estimated Cost:* The average cost for each respondent would be approximately $660. This would include the burden hour costs for extensions or change requests, revisions to existing memorandum of agreements and progress reports. *Comments:* Written comments are solicited to:

(a)Evaluate whether the proposed data collection is necessary for the proper performance of the agency, including whether the information shall have practical utility;

(b)evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(c)enhance the quality, utility, and clarity of the information to be collected; and

(d)minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, *e.g.* , permitting electronic submission of responses. Comments must be submitted on or beforeApril 7, 2006. ADDRESSES: Interested persons should submit written comments to Chief, Records Management Section, Information Resources Management Branch, Information Technology Services Division, Federal Emergency Management Agency, 500 C Street, SW., Room 316, Washington, DC 20472. FOR FURTHER INFORMATION CONTACT: Contact Wanda Casey, Program Specialist, National Urban Search and Rescue Program,

(202)646-4013 for additional information. You may contact the Records Management Branch for copies of the proposed collection of information at facsimile number

(202)646-3347 or e-mail address: *FEMA-Information-Collections@dhs.gov.* Dated: January 31, 2006. George S. Trotter, Acting Branch Chief, Information Resources Management Branch, Information Technology Services Division. [FR Doc. E6-1565 Filed 2-3-06; 8:45 am] BILLING CODE 9110-69-P DEPARTMENT OF HOMELAND SECURITY Transportation Security Administration Extension Agency Information Collection Activity Under OMB Review: Corporate Security Review

(CSR)AGENCY: Transportation Security Administration (TSA), DHS. ACTION: Notice. SUMMARY: This notice announces that TSA has forwarded the new Information Collection Request

(ICR)abstracted below to the Office of Management and Budget

(OMB)for review and approval of an extension of the currently approved collection under the Paperwork Reduction Act. The ICR describes the nature of information collection and its expected burden. TSA published a **Federal Register** notice, with a 60-day comment period soliciting comments, of the following collection of information on October 2, 2005, 70 FR 66454. In response to this notice, TSA received comments from NiSource, a natural gas pipeline company operating in several states. DATES: Send your comments by March 8, 2006. A comment to OMB is most effective if OMB receives it within 30 days of publication. ADDRESSES: Comments may be faxed to the Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: DHS-TSA Desk Officer, at

(202)395-5806. FOR FURTHER INFORMATION CONTACT: Katrina Wawer, Information Collection Specialist, Office of Transportation Security Policy, TSA-9, Transportation Security Administration, 601 South 12th Street, Arlington, VA 22202-4220. SUPPLEMENTARY INFORMATION: Comments Invited In accordance with the Paperwork Reduction Act of 1995, (44 U.S.C. 3501 et seq.), an agency may not conduct or sponsor, and a person is not required to respond to a collection of information, unless it displays a valid OMB control number. Therefore, in preparation for OMB review and approval of the following information collection, TSA is soliciting comments to—

(1)Evaluate whether the proposed information requirement is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(2)Evaluate the accuracy of the agency's estimate of the burden;

(3)Enhance the quality, utility, and clarity of the information to be collected; and

(4)Minimize the burden of the collection of information on those who are to respond, including using appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Information Collection Requirement *Title:* Corporate Security Review (CSR). *Type of Request:* Extension of a currently approved collection. *OMB Control Number:* 1652-0036. *Forms(s):* Corporate Security Review Form. *Affected Public:* Surface transportation system owners and operators. *Abstract:* The Aviation and Transportation Security Act

(ATSA)(Pub. L. 107-71, 115 Stat. 597, Nov. 19, 2001) requires TSA to oversee the security of the nation's surface transportation system. Specifically, ATSA grants TSA authority to execute its responsibilities for: • Enhancing security in all modes of transportation (49 U.S.C. 114(d)); • Assessing intelligence and other information in order to identify individuals who pose a threat to transportation security and to coordinate countermeasures with other Federal agencies to address such threats (49 U.S.C. 114(f)(1)-(5), (h)(1)-(4)); and • Identifying and coordinating countermeasures to address threats to the transportation system (49 U.S.C. 114(f)(4)), including the authority to receive, assess, and distribute intelligence information related to transportation security; (49 U.S.C. 114(f)(1)-(4)). To support these requirements, TSA assesses the current security practices in the surface transportation sector by way of site visits and interviews through its Corporate Security Review

(CSR)program, one piece of a much larger domain awareness, prevention, and protection program in support of TSA's and Department of Homeland Security's missions. TSA is requesting continued approval for this collection to allow TSA to continue to ascertain minimum-security standards and identify coverage gaps, activities that are critical to its mission of ensuring transportation security. TSA assures respondents that the portion of their responses TSA deems Sensitive Security Information will be handled as such, as described in 49 CFR parts 15 and 1520. *Number of Respondents:* 500. *Estimated Annual Burden Hours:* An estimated 1,200 hours annually. Issued in Arlington, Virginia, on January 25, 2006. Lisa S. Dean, Privacy Officer. [FR Doc. E6-1526 Filed 2-3-06; 8:45 am] BILLING CODE 4910-62-P DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services Agency Information Collection Activities: Extension of a Currently Approved Information Collection; Comment Request ACTION: 30-Day Notice of Information Collection Under Review; Application for Suspension of Deportation or Special Rule Cancellation of Removal (Pursuant to Section 203 of Public Law 105-100); Form I-881. OMB Control No. 1615-0072. The Department of Homeland Security, U.S. Citizenship and Immigration Services (USCIS) has submitted the following information collection request to the Office of Management and Budget

(OMB)for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection was previously published in the **Federal Register** on December 5, 2005, at 70 FR 72461. The notice allowed for a 60-day public comment period. No comments were received on this information collection. The purpose of this notice is to allow an additional 30 days for public comments. Comments are encouraged and will be accepted until March 8, 2006. This process is conducted in accordance with 5 CFR 1320.10. Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the Department of Homeland Security (DHS), USCIS, Director, Regulatory Management Division, Clearance Office, 111 Massachusetts Avenue, 3rd floor, Washington, DC 20529. Comments may also be submitted to DHS via facsimile to 202-272-8352 or via e-mail at *rfs.regs@dhs.gov.* When submitting comments by e-mail please make sure to add OMB Control Number 1615-0072 in the subject box. Written comments and suggestions from the public and affected agencies should address one or more of the following four points:

(1)Evaluate whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(2)Evaluate the accuracy of the agencies estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;

(3)Enhance the quality, utility, and clarity of the information to be collected; and

(4)Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, *e.g.* , permitting electronic submission of responses. Overview of this information collection:

(1)*Type of Information Collection:* Extension of existing information collection.

(2)*Title of the Form/Collection:* Application for Suspension of Deportation or Special Rule Cancellation of Removal (Pursuant to Section 203 of Public Law 105-100).

(3)*Agency form number, if any, and the applicable component of the Department of Homeland Security sponsoring the collection:* Form I-881. U.S. Citizenship and Immigration Services.

(4)*Affected public who will be asked or required to respond, as well as a brief abstract:* Primary: Individuals and households. This form is used by a nonimmigrant to apply for suspension of deportation or special rule cancellation of removal. The information collected on this form is necessary in order for USCIS to determine if it has jurisdiction over an individual applying for this release as well as to elicit information regarding the eligibility of an individual applying for release pursuant to section 203 of the Nicaraguan Adjustment and Central American Relief Act (NACARA); Pub. L. 105-100.

(5)*An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond:* 55,000 responses at 12 hours per response.

(6)*An estimate of the total public burden (in hours) associated with the collection:* 660,000 annual burden hours. If you have additional comments, suggestions, or need a copy of the proposed information collection instrument with instructions, or additional information, please visit the USCIS Web site at: *http://uscis.gov/graphics/formsfee/forms/pra/index.htm.* If additional information is required contact: USCIS, Regulatory Management Division, 111 Massachusetts Avenue, 3rd Floor, Washington, DC 20529,

(202)272-8377. Dated: January 30, 2006. Stephen Tarragon, Deputy Director, Regulatory Management Division, U.S. Citizenship and Immigration Services. [FR Doc. 06-985 Filed 2-3-06; 8:45 am]

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U.S. Code