Notices. Notice

6,810 words·~31 min read·/register/2008/01/16/08-125

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

BILLING CODE 6712-01-P FEDERAL MARITIME COMMISSION Notice of Agreements Filed The Commission hereby gives notice of the filing of the following agreements under the Shipping Act of 1984. Interested parties may submit comments on agreements to the Secretary, Federal Maritime Commission, Washington, DC 20573, within ten days of the date this notice appears in the **Federal Register** . Copies of agreements are available through the Commission's Office of Agreements (202-523-5793 or *tradeanalysis@fmc.gov* ). *Agreement No.:* 012022. *Title:* Discovery Cruise Line/Bernuth Lines Slot Charter Agreement. *Parties:* Discovery Sun Partnership and Bernuth Lines, Ltd., Inc. *Filing Party:* Glenn G.

Kolk, Esq.; 520 Brickell Key Drive Suite 1606; Miami, FL 33131. *Synopsis:* The agreement authorizes Discovery and Bernuth to charter space to each other between the U.S. Atlantic Coast and the Bahamas. *Agreement No.:* 200163-002. *Title:* Gulf Seaports Marine Terminal Conference. *Parties:* Alabama State Docks Department, Greater Baton Rouge Port Commission, Port of Beaumont, Brownsville Navigation District, Port of Corpus Christi Authority, Port Freeport, Galveston Wharves, Port of Houston Authority, Lake Charles Harbor and Terminal District, Manatee County Port Authority, Mississippi State Port Authority, Port of New Orleans, Orange County Navigation and Port District, Panama City Port Authority, Port of Pascagoula, Port of Pensacola, Plaquemines Port, Port of Port Arthur, St.

Bernard Port, South Louisiana Port Commission, and Tampa Port Authority. *Filing Party:* John Roby, Chairman; Port of Beaumont; P.O. Drawer 2297; Beaumont, TX 77704. *Synopsis:* The amendment adds Plaquemines Ports as a party to the conference and updates Port Freeport's name. *Agreement No.:* 201176. *Title:* License Agreement—Guam/Matson Navigation Co., Inc/Horizon Lines, Inc. *Parties:* Horizon Lines, LLC; Matson Navigation Co.; and the Port Authority of Guam. *Filing Party:* Matthew J.

Thomas; Troutman Sanders LLP; 401 9th Street, NW., Ste. 1000; Washington, DC 20004-2134. *Synopsis:* Under the terms of the agreement, the port authority grants Matson Navigation and Horizon Lines certain rights to install cranes at its facilities. By order of the Federal Maritime Commission. Dated: January 11, 2008. Karen V. Gregory, Assistant Secretary. [FR Doc. E8-682 Filed 1-15-08; 8:45 am] BILLING CODE 6730-01-P FEDERAL MARITIME COMMISSION Ocean Transportation Intermediary License Revocations The Federal Maritime Commission hereby gives notice that the following Ocean Transportation Intermediary licenses have been revoked pursuant to section 19 of the Shipping Act of 1984 (46 U.S.C.

Chapter 409) and the regulations of the Commission pertaining to the licensing of Ocean Transportation Intermediaries, 46 CFR Part 515, effective on the corresponding date shown below: *License Number:* 020308N. *Name:* ACM International, Corp. dba ACM Cargo. *Address:* 2225 W. Commonwealth Ave., Ste. 102, Alhambra, CA 91803. *Date Revoked:* December 2, 2007. *Reason:* Failed to maintain a valid bond. *License Number:* 020345N. *Name:* Cargo Station dba Accord Logistics USA. *Address:* 2726 Fruitland Ave., Vernon, CA 90058. *Date Revoked:* November 23, 2007. *Reason:* Failed to maintain a valid bond. *License Number:* 015871N. *Name:* Continental Shipping Line, Inc. *Address:* 34 Mardi Gras Rd., Coronado, CA 92118. *Date Revoked:* November 26, 2007. *Reason:* Failed to maintain a valid bond. *License Number:* 019505NF. *Name:* Delmar Logistics

(GA)Inc. *Address:* 4345 International Parkway, Ste. 110, Atlanta, GA 30354. *Date Revoked:* December 19, 2007. *Reason:* Surrendered license voluntarily. *License Number:* 004114F. *Name:* Faith Freight Forwarding. *Address:* 6701 NW 7th Street, Ste. 190/199, Miami, FL 33126. *Date Revoked:* December 5, 2007. *Reason:* Failed to maintain a valid bond. *License Number:* 014393N *Name:* K-Logic, Inc. *Address:* 360 N. Sepulveda Blvd., Ste. 1056, El Segundo, CA 90245. *Date Revoked:* December 20, 2007. *Reason:* Failed to maintain a valid bond. *License Number:* 003001F. *Name:* Kathleen Tansey Riggs Dba Tansey & Riggs. *Address:* 25422 Trabuco Rd., Ste. 105-446, Lake Forest, CA 92630. *Date Revoked:* November 30, 2007. *Reason:* Failed to maintain a valid bond. *License Number:* 020470N. *Name:* Mega Logistics International, Inc. *Address:* 1110 South Ave., @ Lois Lane, Staten Island, NY 10314. *Date Revoked:* December 5, 2007. *Reason:* Surrendered license voluntarily. *License Number:* 017574N. *Name:* Monetti Distributors, Inc. Dba Monetti Cargo (M.C.) Int'l. Freight Forwarders. *Address:* 8601 Nw 81st Rd., Ste. 15-16, Medley, Fl 33166. *Date Revoked:* December 19, 2007. *Reason:* Failed to maintain a valid bond. *License Number:* 020010F. *Name:* Mudanza La Gaviota Shipping Inc. *Address:* 468 Roseville Ave., Newark, NJ 07107. *Date Revoked:* December 7, 2007. *Reason:* Failed to maintain a valid bond. *License Number:* 018053N. *Name:* Pacific-Net Logistics

(NYC)Inc. *Address:* 151-02 132nd Ave., (AIP), Jamaica, NY 11434. *Date Revoked:* December 15, 2007. *Reason:* Failed to maintain a valid bond. *License Number:* 016874F. *Name:* 7M Transport, Inc. *Address:* 18306 Lazy Moss Lane, Ste. 207, Spring, TX 77379 *Date Revoked:* November 22, 2007. *Reason:* Failed to maintain a valid bond. *License Number:* 003085F. *Name:* Schley International, Inc. *Address:* 1415 East Dublin-Granville Rd., Ste. 115, Columbus, OH 43229. *Date Revoked:* November 22, 2007. *Reason:* Failed to maintain a valid bond. *License Number:* 001992F. *Name:* David A. Spreen Dba Spreen Import/Export Ltd. *Address:* 40104 FM 2979 Rd., Hempstead, TX 77445. *Date Revoked:* December 4, 2007. *Reason:* Surrendered license voluntarily. *License Number:* 019894NF. *Name:* Swift Global Logistics, Inc. *Address:* 6040 Avion Drive, Ste. 210, Los Angeles, CA 90045. *Date Revoked:* December 7, 2007. *Reason:* Failed to maintain valid bonds. *License Number:* 008321N. *Name:* Transworld Freight Systems, Inc. *Address:* 747 S. Glasgow Ave., Inglewood, CA 90301. *Date Revoked:* December 15, 2007. *Reason:* Failed to maintain a valid bond. *License Number:* 003002F. *Name:* Sea to Sea Foreign Freight Forwarder Inc. *Address:* The Bourse Building, Ste. 964, 21 South 5th Street, Philadelphia, PA 19106. *Date Revoked:* December 31, 2007. *Reason:* Surrendered license voluntarily. *License Number:* 015129N. *Name:* Vanguard Moving and Storage Co., Inc. Dba Guardship. *Address:* 8415 Kelso Drive, Ste. 300, Baltimore, MD 21221. *Date Revoked:* November 29, 2007. *Reason:* Failed to maintain a valid bond. *License Number:* 019176N. *Name:* Superior Transportation, L.L.C. *Address:* 319 Wilson Ave., Newark, NJ 07105. *Date Revoked:* November 14, 2007. *Reason:* Surrendered license voluntarily. Sandra L. Kusumoto, Director, Bureau of Certification and Licensing. [FR Doc. E8-686 Filed 1-15-08; 8:45 am] BILLING CODE 6730-01-P FEDERAL RESERVE SYSTEM Change in Bank Control Notices; Acquisition of Shares of Bank or Bank Holding Companies The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board’s Regulation Y (12 CFR 225.41) to acquire a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)). The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the office of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than January 30, 2008. **A. Federal Reserve Bank of St. Louis** (Glenda Wilson, Community Affairs Officer) 411 Locust Street, St. Louis, Missouri 63166-2034: *1. Philip E. Bradshaw Revocable Trust, Philip E. Bradshaw, as trustee, and The Bradshaw Family Group, consisting of the Philip E. Bradshaw Revocable Trust and the Linda L. Bradshaw Revocable Trust, Linda L. Bradshaw, as trustee, as a group acting in concert* ; to retain voting shares of Griggsville Bancshares, Inc., and thereby indirectly retain voting shares of Farmers National Bank of Griggsville, all of Griggsville, Illinois. Board of Governors of the Federal Reserve System, January 10, 2008. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E8-546 Filed 1-15-08; 8:45 am] BILLING CODE 6210-01-S FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 *et seq.* ) (BHC Act), Regulation Y (12 CFR Part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below. The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The application also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Additional information on all bank holding companies may be obtained from the National Information Center website at *www.ffiec.gov/nic/* . Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than February 11, 2008. **A. Federal Reserve Bank of Minneapolis** (Jacqueline G. King, Community Affairs Officer) 90 Hennepin Avenue, Minneapolis, Minnesota 55480-0291: *1. BancMidwest Corporation, St. Paul, Minnesota;* to acquire 100 percent of Hiawatha Bancshares Inc., Hager City, Wisconsin and thereby indirectly acquire Hiawatha National Bank, N.A., Hager City, Wisconsin. Board of Governors of the Federal Reserve System, January 11, 2008. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E8-636 Filed 1-15-07; 8:45 am] BILLING CODE 6210-01-S FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 *et seq.* ) (BHC Act), Regulation Y (12 CFR Part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below. The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Additional information on all bank holding companies may be obtained from the National Information Center website at *www.ffiec.gov/nic/* . Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than February 8, 2008. **A. Federal Reserve Bank of Chicago** (Burl Thornton, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414: *1. TG Bancshares, Inc.* , Table Grove, Illinois; to become a bank holding company by acquiring 100 percent of the voting shares of Table Grove State Bank, Table Grove, Illinois. **B. Federal Reserve Bank of St. Louis** (Glenda Wilson, Community Affairs Officer) 411 Locust Street, St. Louis, Missouri 63166-2034: *1. Germantown Capital Corporation, Inc.* , Germantown, Tennessee; to become a bank holding company by acquiring 100 percent of the voting shares of First Capital Bank, Germantown, Tennessee. Board of Governors of the Federal Reserve System, January 10, 2008. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc.E8-547 Filed 1-15-08; 8:45 am] BILLING CODE 6210-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2003N-0573] Animal Cloning Risk Assessment; Risk Management Plan; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of a risk assessment on animal cloning. FDA's Center for Veterinary Medicine

(CVM)developed this risk assessment to evaluate the health risks to animals involved in the process of cloning and to evaluate the food consumption risks that may result from edible products derived from animal clones or their progeny. FDA is also announcing the availability of a risk management plan for animal clones and their progeny. The risk management plan takes into account the risks identified in the risk assessment and sets out measures that FDA will use to manage those risks. In addition, FDA is announcing availability of guidance for industry 179. This guidance describes FDA's recommendations regarding the use of edible products from animal clones and their progeny in human food or in animal feed. DATES: Submit written or electronic comments on agency guidances at any time. ADDRESSES: Submit written requests for single copies of the risk assessment, risk management plan, or the guidance for industry to the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send a self-addressed, adhesive label to assist that office in processing your request. Submit written comments on the guidance for industry to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . See the SUPPLEMENTARY INFORMATION section for electronic access to the documents. FOR FURTHER INFORMATION CONTACT: Larisa Rudenko, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8245, e-mail: *clones@cvm.fda.gov* . SUPPLEMENTARY INFORMATION: I. Background In the **Federal Register** of January 3, 2007 (72 FR 136), FDA published a notice of availability with a 90-day comment period to request comments on a draft risk assessment on animal cloning. FDA also announced the availability for public comment of a proposed risk management plan for animal clones and their progeny and a draft guidance for industry describing FDA's recommendations regarding the use of edible products from animal clones and their progeny in human food or in animal feed. In response to requests to extend the comment period on these documents, FDA subsequently published a notice in the **Federal Register** (72 FR 15887, April 3, 2007) extending the comment period for an additional 30 days. The draft risk assessment evaluated the health effects to animals involved in the process of cloning and evaluated the food consumption risks that may result from edible products derived from animal clones or their progeny. The proposed risk management plan described proposed measures that the agency might use to address animal health and food consumption risks identified in the draft risk assessment that were within the agency's purview. It also described the agency's plans with regard to issues that were not within the agency's authority to manage (e.g., ethics) regarding animal cloning. The draft guidance for industry described FDA's recommendations regarding the introduction of edible products from animal clones and their progeny into the food and feed supply. FDA has completed a thorough analysis of all comments and additional information received and has updated the documents appropriately. FDA has concluded that meat and milk from clones of cattle, swine, and goats, and the offspring of clones from any species traditionally consumed as food, are as safe to eat as food from conventionally bred animals. FDA, however, in its guidance for industry, is recommending that edible products from clones from animals other than cattle, swine, or goat (e.g., sheep) not be introduced into the human food supply. Whereas the scientific data supports the safety of edible products from clones of cattle, swine, or goat, there is insufficient scientific data to reach this conclusion for edible products from other types of animals. II. Significance of Guidance The guidance for industry is a level 1 guidance that is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on the topic. The guidance document does not create or confer any rights for or on any person and will not operate to bind FDA or the public. Alternative methods may be used as long as they satisfy the requirements of the applicable statutes and regulations. III. Paperwork Reduction Act of 1995 For this level 1 final guidance, FDA concludes that there are no collection of information requirements under the Paperwork Reduction Act of 1995. IV. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding the guidance for industry. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that in January 2008 the FDA Web site is expected to transition to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. After the transition date electronic submissions will be accepted by FDA through the FDMS only. When the exact date of the transition to FDMS is known, FDA will publish a **Federal Register** notice announcing that date. V. Electronic Access Persons with access to the Internet may obtain the documents at *http://www.fda.gov/cvm/cloning.htm* . Dated: January 3, 2008. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E8-675 Filed 1-15-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0390] User Fee Program for Advisory Review of Direct-to-Consumer Television Advertisements for Prescription Drug and Biological Products; Program Will Not Be Implemented AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is issuing this notice to inform companies that the Direct-to-Consumer

(DTC)television advertisement user fee program will not commence because the necessary user fees for the program were not “provided in advance in appropriations Acts” as required by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and the previously issued notice establishing user fee rates for the program for fiscal year

(FY)2008 is being withdrawn. FOR FURTHER INFORMATION CONTACT: Wayne Amchin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 1454, Silver Spring, MD 20993-0002, 301-796-1200, FAX: 301-796-9878, e-mail: *dtcp@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: On September 27, 2007, the President signed into law FDAAA (Public Law 110-85). Title I of FDAAA reauthorized the Prescription Drug User Fee Act for FYs 2008 to 2012. In addition, Title I created new section 736A of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 379h-1), which authorized a new and separate user fee program for the advisory review of DTC prescription drug television advertisements. The DTC user fee program would have been available to companies interested in voluntarily submitting to FDA for advisory review a DTC television advertisement, as defined in section 736A(h)(4) of the act. FDAAA provided, however, that if FDA fails to receive at least $11,250,000 in advisory review fees and operating reserve fees combined by 120 days after the legislation is enacted (i.e., by January 25, 2008), the program shall not commence (section 736A(f)(1) of the act). FDAAA also provided that the fees authorized for the DTC program “shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts.” (section 736A(g)(1) of the act). On December 26, 2007, the President signed the Consolidated Appropriations Act, 2008 (Public Law 110-161). The law does not appropriate user fee funds for the voluntary review of DTC television advertisements. As a result, under section 736A(g)(1) of the act, FDA does not have the authority to collect and spend user fees for this purpose. Furthermore, as noted previously, section 736A(f)(1) of the act provides that if FDA has not collected at least $11,250,000 in advisory review fees and operating reserve fees combined by 120 days after the legislation is enacted (i.e., by January 25, 2008), the program shall not commence. Therefore, no invoices will be sent. Advertisements voluntarily submitted for FDA review will be reviewed in as timely a manner as resources permit. In addition, FDA is withdrawing the previously issued **Federal Register** notice establishing the user fee rates for this program for FY 2008 (72 FR 70334, December 11, 2007). Dated: January 10, 2008. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E8-740 Filed 1-15-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Psychopharmacologic Drugs Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration

(FDA)is announcing an amendment to the notice of meeting of the Psychopharmacologic Drugs Advisory Committee. This meeting was announced in the **Federal Register** of December 19, 2007 (72 FR 71923). The amendment is being made to reflect changes in the *Location, Contact Person, and Procedure* portions of the document. There are no other changes. FOR FURTHER INFORMATION CONTACT: Diem-Kieu Ngo, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301-827-7001, FAX: 301-827-6776, e-mail: *diem.ngo@fda.hhs.gov* , or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington DC area), code 3014512544. Please call the Information Line for up-to-date information on this meeting. SUPPLEMENTARY INFORMATION: In the **Federal Register** of December 19, 2007, FDA announced that a meeting of the Psychopharmacologic Drugs Advisory Committee would be held on February 6, 2008. On page 71923, in the third column, the *Location* portion of the document is changed to read as follows: *Location* : Crowne Plaza/Silver Spring, Kennedy Ballrooms, 8777 Georgia Ave., Silver Spring, MD. The hotel telephone number is 301-589-0800. On page 71923, in the third column, the first sentence of the *Contact Person* portion of the document is changed to read as follows: *Contact Person* : Diem-Kieu Ngo, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301-827-7001, FAX: 301-827-6776, e-mail: *diem.ngo@fda.hhs.gov* , or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512544. On page 71924, in the first column, the first paragraph of the *Procedure* portion of the document is changed to read as follows: *Procedure* : Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before January 18, 2008. Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2:30 p.m. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before January 10, 2008. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by January 11, 2008. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees. Dated: January 10, 2008. Randall W. Lutter, Assistant Commissioner for Policy. [FR Doc. E8-726 Filed 1-15-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; Comment Request; Quality of Life Outcomes in Neurological Disorders SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Neurological Disorders and Stroke (NINDS), the National Institutes of Health

(NIH)has submitted to the Office of Management and Budget

(OMB)a request to review and approve the information collection listed below. This proposed information collection was previously published in the **Federal Register** on September 24, 2007, page number 54269 and allowed 60 days for public comment. One public comment was received; also received were one request for the data collection plans and proposed instruments and a request for information on a related Web site. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. *Proposed Collection: Title:* Quality of Life Outcomes in Neurological Disorders; *Type of Information Collection Request:* New; *Form Number:* NA; *Need and Use of Information Collection:* In order to improve outcome measurement in clinical trials of neurological conditions, NINDS is developing a health-related quality of life

(HRQL)measurement system for major neurological diseases that affect the United States population. This measurement system must be consistent enough across the selected conditions to allow for cross-disease comparison, and yet flexible enough to capture condition-specific HRQL issues. The primary end users of this measurement system will be clinical trialists and other clinical neurology researchers; however the measurement system will also be appropriate for clinical practice. The proposed information collection will support psychometric testing of HRQL item banks and testing of Spanish translation of the final questionnaires. *Frequency of Response:* Once; *Affected Public:* Individuals; *Type of Respondent:* Adults and children. The annual reporting burden is shown in the following table. There are no Capital Costs, Operating Costs or Maintenance Costs to report. Type of respondents Number of respondents Frequency of response Average time per response Annual hour burden Adults 6,000 1 0.5 3,000 Children 3,000 1 0.5 1,500 Totals 9,000 4,500 *Request for Comments:* Written comments and/or suggestions from the public and affected agencies should address one or more of the following points:

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

(2)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;

(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 the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. *Direct Comments to OMB:* 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: Office of Management and Budget, Office of Regulatory Affairs, New Executive Office Building, Room 10235, Washington, DC 20503, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Dr. Claudia Moy, Program Director, Clinical Trials Group, NINDS, NIH, Neuroscience Center, 6001 Executive Boulevard, Room 2214, Bethesda, MD 20892, or call non-toll-free number 301-496-2789 or e-mail your request, including your address to: < *moyc@ninds.nih.gov* >. *Comments Due Date:* Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. Dated: December 20, 2007. Joellen Austin Harper, Executive Officer, NINDS, National Institutes of Health. [FR Doc. E8-606 Filed 1-15-08; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Child Health and Human Development; Longitudinal Investigation of Fertility and the Environment Study SUMMARY: In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Child Health and Human Development (NICHD), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget

(OMB)for review and approval. This is a request for renewal of an information collection request that was approved (OMB Clearance 0925-0543) following publication in the **Federal Register** on January 9, 2004, page 1589 and December 2, 2004, page 70153. *Proposed Collection: Title:* Longitudinal Investigation of Fertility and the Environment Study. * Type of Information Collection Request: * Renewal of OMB Clearance 0925-0543. *Need and Use of Information Collection:* This study will assess the relation between select environmental factors and human fecundity and fertility. This research originally proposed to recruit 960 couples who are interested in becoming pregnant and willing to participate in a longitudinal study. Fewer than expected couples were enrolled during the first three years of the project (n=350), predominantly due to the fact that more couples were ineligible for participation than had been originally estimated. In light of this fact, the revised study plan is to enroll a total of 500 couples (i.e., 150 additional couples), a sample size that will not compromise the main study objectives. Fecundity will be measured by the time required for the couples to achieve pregnancy, while fertility will be measured by the ability of couples to have a live born infant. Couples who are unable to conceive within 12 months of trying or who experience a miscarriage also will be identified and considered to have fecundity-related impairments. The study's primary environmental exposures include: Organochlorine pesticides and polychlorinated biphenyls; metals; fluorinated compounds; phytoestrogens; and phthalates. A growing body of literature suggests these compounds may exert effects on human reproduction and development; however, definitive data are lacking serving as the impetus for this study. Couples will participate in a 20-30 minute baseline interview and be instructed in the use of home fertility monitors and pregnancy kits for counting the time required for pregnancy and detecting pregnancy. Blood and urine samples will be collected at baseline from both partners of the couple for measurement of the environmental exposures. Two semen samples from male partners and two saliva samples from female partners also will be requested. Semen samples will be used to assess male fecundity as measured primarily by sperm concentration and morphology. Saliva samples will be used for the measurement of cortisol levels as a marker of stress among female partners so that the relation between environmental factors, stress and human reproduction can be assessed. The findings will provide valuable information regarding the effect of environmental contaminants on sensitive markers of human reproduction and development, filling critical data gaps. Moreover, these environmental exposures will be analyzed in the context of other lifestyle exposures, consistent with the manner in which human beings are exposed. *Frequency of Response:* Following the baseline interview, couples will each complete a five-minute daily diary on select lifestyle factors. Women will perform daily fertility testing and pregnancy testing at day of expected menses using a dipstick test in urine. Each test will require approximately five minutes for completion. This testing and diary reporting is required only up to the time women become pregnant, which on average should be in 2-3 months. Men will provide two semen samples, a month apart, requiring approximately 20 minutes for each collection, and women will collect two saliva samples, a month apart, requiring approximately five minutes. Participating couples will be given a choice to submit their information by mail or to send it electronically to the Data Coordinating Center. This option will be available throughout data collection in the event couples change their minds about how they would like to submit information. Bio-specimens will be collected by study participants and research nurses, where appropriate, and forwarded in prepaid delivery packages to the study's laboratories. *Affected Public:* Individuals from participating communities. *Type of Respondents:* Men and women aged 18-40 years. *Revised Estimated Number of Respondents:* 1,000. *Revised Estimated Number of Response Sets per Respondent:* 6 per women and 3 per men over approximately two years. *Average Burden Hours per Response:* .1947 for women and .31975 for men. *Revised Estimated Total Annual Burden Hours Requested:* 1,658 for women and 889 for men. The revised burden estimates represent a 48 percent reduction in the originally requested burden. There is no cost to respondents. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. *Request for Comments:* Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points:

(1)The necessity of the proposed collection of information for the proper performance of the function of the agency, including the practical utility of the information;

(2)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;

(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 those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Dr. Germaine Buck Louis, Senior Investigator and Chief, Epidemiology Branch, DESPR, NICHD, NIH, 6100 Executive Blvd., Room 7B03, Rockville, Maryland 20852, or call non-toll-free number

(301)496-6155 or e-mail your request, including your address to: *gb156i@nih.gov.* *Comments Due Date:* Comments regarding this information collection are best assured of having their full effect if received within 60-days of the date of this publication. Dated: January 3, 2008. Paul Johnson, NICHD Project Clearance Liaison, National Institutes of Health. [FR Doc. E8-609 Filed 1-15-08; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health The Statement of Organization, Functions, and Delegations of Authority Part N, National Institutes of Health (NIH), of the Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services

(DHHS)(40 FR 22859, May 27, 1975, as amended most recently at 72 FR 57595, October 10, 2007, and redesignated from Part HN as Part N at 60 FR 56605, November 9, 1995), is amended as set forth below to reflect the transfer of the functions of the Chief Information Officer

(CIO)from the Center for Information Technology (NU, formerly HNU) to the Office of the Director (NA, formerly HNA). *Section N-B, Organization and Functions,* under the heading Center for Information Technology (NU, formerly HNU), is amended as follows:

(1)Replace the current section NU (formerly HNU) with the following: *Center for Information Technology (NU, formerly HNU).*

(1)Provides leadership for the determination of NIH computational and telecommunications needs at all levels and oversees the development of appropriate infrastructure support to meet identified needs;

(2)develops, operates, and maintains a state-of-the-art regional computer facility and provides overall guidance based on legislation and policy that is responsive to the NIH mission;

(3)establishes and operates the necessary organization and infrastructure to assure appropriate security, connectivity, and inter-operability across the NIH Institutes and Centers (ICs), off-campus locations, and remote access;

(4)collaborates on, and provides for, research activities in the computational biosciences and statistics;

(5)develops, administers, and manages NIH systems, and provides consulting services to the ICs, in support of administrative and business applications; and

(6)serves as a Federal Data Processing Center for administrative, biomedical, and statistical computing, provides data processing and high performance computing facilities and integrated telecommunications data networks, and provides services to the DHHS and other Federal agencies.

(2)Delete in their entirety the statements for *Office of the Deputy CIO (NU9, formerly HNU9);* the *Information Technology Policy and Review Office (NU92, formerly HNU92,* the *Information Security and Awareness Office (NU93, formerly HNU93);* the *Information Technology Acquisitions Services Office (NU94, formerly HNU94);* and the *Office of the Chief Information Technology Architect (NU19, formerly HNU19).*

(3)*Section N-B, Organization and Functions,* under the heading *Office of the Director (NA, formerly HNA),* is amended as follows: Under the heading *Office of the Director (NA, formerly HNA),* immediately following the statement for Office of Portfolio Analysis and Strategic Initiatives

(HNAU)insert the following: *Office of the Chief Information Officer (NAV, formerly HNAV).*

(1)Advises the NIH Director on the strategic direction and management of significant NIH Information Technology

(IT)program and policy activities;

(2)provides leadership for the enhancement of NIH IT capabilities, scientific and research computing services, and enterprise systems through policies, guidelines and standards, budget management, and lifecycle performance monitoring;

(3)directs the establishment of a common infrastructure that optimizes NIH's IT investments and that can adapt to emerging technologies and service models;

(4)leads IT security initiatives to protect and secure NIH's information assets;

(5)oversees the NIH-wide IT investment portfolio, inclusive of IC, CIT, and enterprise systems;

(6)approves the progress of enterprise projects through the DHHS Enterprise Performance Life Cycle (EPLC);

(7)identifies critical IT issues and analyzes, plans, and leads NIH's implementation of special DHHS or Federal initiatives related to management of IT resources;

(8)leads IT governance structure to align IT with NIH strategies and objectives;

(9)leads the implementation of enterprise architecture policies, standards, and practices;

(10)leads NIH IT support efforts on medical initiatives such as Electronic Health Record; and

(11)provides leadership and focus within NIH for the development and implementation of policy and standards in IT by identifying, documenting, and communicating issues, problems, and solutions to the NIH community in a comprehensive way. *Information Technology Policy and Review Office (NAV2, formerly HNAV2).* Advises and assists the NIH Chief and Deputy Chief Information Officers in managing NIH IT resources and investments through

(1)development, implementation, and oversight of NIH IT policy and guidance;

(2)interpretation and implementation of laws, regulations, and DHHS, Office of Management and Budget (OMB), and other Federal mandates;

(3)development and oversight of IT capital planning and investment control activities;

(4)coordination and preparation of IT budget and review documents;

(5)development of IT management tools and training; and

(6)provision of staff support to CIO committees and special initiatives, studies, and projects. *Information Security and Awareness Office (NAV3, formerly HNAV3).* Provides guidance to the NIH Chief and Deputy Chief Information Officers regarding IT security, planning, and budget activities by

(1)leading the development of program goals, policies, standards, and procedures for the NIH IT Security program;

(2)providing guidance to ICs for security of information in accordance with the Privacy Act, the Computer Security Act of 1987, the Information Technology Management Reform Act (ITMRA), OMB, and DHHS guidance;

(3)providing support to the NIH IT Management Committee (ITMC);

(4)conducting NIH-wide IT security activities;

(5)managing an NIH Incident Response Team;

(6)managing an NIH Risk Management and Oversight Program; and

(7)managing an NIH IT Security Awareness and Training Program. *Information Technology Acquisition Services Office (NAV4, formerly HNAV4).* Advises the NIH Chief and Deputy Chief Information Officers on IT contract expenditures and IT trends by

(1)maintaining awareness of federally mandated laws, regulations, and standards as they relate to IT acquisition documents and IT investments;

(2)participating in NIH-wide committees that impact NIH CIO initiatives, policies, and standards;

(3)working closely with other ICs to ensure that NIH CIO initiatives and practices are reflected in IT submissions to DHHS and OMB;

(4)assisting in the preparation of Statements of Work and supporting documentation such as schedules, evaluation criteria, and checklists required to implement the ITMRA, maintaining consistency with NIH/DHHS/OMB policies;

(5)assisting NIH program managers in identifying appropriate mechanisms to satisfy their IT requirements, including NIH acquisition resources; and

(6)advising NIH IT project managers on contract/task order management, administrative strategies, problem resolution, and techniques via meetings, e-mail, handbooks, and/or briefings. *Information Technology Architecture Office (NAV5, formerly HNAV5).*

(1)Advises the CIO on IT enterprise architecture for the NIH;

(2)provides leadership to the development and management of an NIH enterprise architecture;

(3)develops principles, policy, and technology standards to guide IT systems design and integration;

(4)leads and/or evaluates enterprise projects and technologies for compliance and integration within IT architecture;

(5)coordinates and represents IT enterprise architecture for the NIH; and

(6)provides leadership, management, and implementation of transforming technologies for NIH such as Federal Public Key Infrastructure, Enterprise Application Integration Infrastructure, and Enterprise Identity Management Infrastructure, including the redesign of the NIH Enterprise Directory. *Delegations of Authority:* All delegations and redelegations of authority to officers and employees of NIH which were in effect immediately prior to the effective date of this reorganization and are consistent with this reorganization shall continue in effect, pending further redelegation. Dated: January 7, 2008. Elias A. Zerhouni, Director, National Institutes of Health. [FR Doc. 08-125 Filed 1-15-08; 8:45 am]

Connectionstraces to 7

Traces to 7 documents

U.S. Code

CFR

5 references not yet in our index