Notices. Notice and request for comment

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

BILLING CODE 6705-01-P FEDERAL DEPOSIT INSURANCE CORPORATION Agency Information Collection Activities: Proposed Information Collection; Comment Request AGENCY: Federal Deposit Insurance Corporation (FDIC). ACTION: Notice and request for comment. SUMMARY: In accordance with the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget

(OMB)control number. The FDIC is contemplating initiating a two-year pilot program relating to small-dollar lending by insured depository institutions. Institutions meeting threshold eligibility requirements may volunteer to participate in the pilot, and the collection at this first stage would provide certain basic information as to the institution and its current or proposed small-dollar lending program. Participating institutions would thereafter provide certain information to the FDIC about their ongoing experience with their small-dollar lending program. The collection at this second stage would provide information on the most effective and replicable business practices to incorporate affordable small-dollar loans into effective business models to reach out to underserved communities and to develop new customers for mainstream banking services, whether consumers who take advantage of such loans migrate into other banking products, and whether a savings component provides a steady increase in savings. DATES: Comments must be submitted on or before August 6, 2007. ADDRESSES: You may submit comments by any of the following methods: • *Agency Web Site: http://www.fdic.gov/regulations/laws/federal.* Follow instructions for submitting comments on the Agency Web Site. • *E-mail: Comments@FDIC.gov.* • *Mail:* Leneta Gregorie, Legal Division, Attention: Comments, Federal Deposit Insurance Corporation, 550 17th Street, NW., Washington, DC 20429. • *Hand Delivery/Courier:* Guard station at the rear of the 550 17th Street Building (located on F Street) on business days between 7 a.m. and 5 p.m. (EST). All comments should refer to “Pilot Study of Small Dollar Loan Programs.” Copies of comments may also be submitted to the OMB desk officer for the FDIC, Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Washington, DC 20503. *Public Inspection:* All comments received will be posted without change to *http://www.fdic.gov/regulations/laws/federal* including any personal information provided. Comments may be inspected and photocopied in the FDIC Public Information Center, 3501 North Fairfax Drive, Room E-1002, Arlington, VA 22226, between 9 a.m. and 5 p.m.

(EST)on business days. Paper copies of public comments may be ordered from the Public Information Center by telephone at

(877)275-3342 or

(703)562-2200. FOR FURTHER INFORMATION CONTACT: Interested members of the public may obtain additional information about the collection, including a copy of the proposed collection and related instructions, without charge, by contacting Leneta Gregorie at the address identified above or by calling 202-898-3719. SUPPLEMENTARY INFORMATION: Proposal To Seek OMB Approval for the Following New Collection of Information *Title:* Pilot Study of Small-Dollar Loan Programs. *OMB Number:* New collection (3064-xxxx). *Frequency of Response:* Pilot study application—one-time; Program evaluation reports—quarterly for two years. *Affected Public:* Insured depository institutions that apply for and are accepted to participate in the pilot study. *Estimated Number of Respondents:* Pilot study application—40; Program evaluation reports—20 to 40. *Estimated time per response:* Pilot study application: Estimated average of 2 hours per respondent. Program evaluation reports: Estimated average of 5 hours per respondent per quarter during study. *Estimated Total Annual Burden:* *Pilot study application:* 40 respondents times 2 hours per respondent = 80 hours. *Program evaluation reports:* 20 to 40 respondents times 5 hours per respondent times 4 (quarterly) collections = 400 to 800 aggregate hours. Total burden = 80 + 800 = 880 hours. General Description of Collection In recognition of the huge demand for small-dollar, unsecured loans, as evidenced by the proliferation around the country of payday lenders, the FDIC, on December 4, 2006, proposed and sought comment on guidelines for such products ( *http://www.fdic.gov/news/news/press/2006/pr06107.html* ). The proposed guidelines addressed several aspects of product development, including affordability and streamlined underwriting. Based on the comments received, the FDIC is in the process of revising the guidelines for issuance in final form. The FDIC's goal in issuing the guidance is to encourage state nonmember banks to offer small-dollar, unsecured loans in a safe and sound manner that is also cost-effective and responsive to customer needs. To further encourage the development by insured depository institutions of small-dollar credit programs, the FDIC is contemplating conducting a pilot study to identify and evaluate the key components of small-dollar loan programs, with the goal of identifying the most effective and replicable business plans for bankers, determining the degree to which customers of such programs migrate into other banking products, assessing the extent to which a savings component results in increased savings, and identifying program features which can be deemed “best practices.” Programs selected for the pilot may be either already in existence at an insured institution or developed specifically for participation in the study. The pilot study will require collection of data from applicant institutions to determine eligibility as well as quarterly collection (for two years) of data from participating institutions, to the extent such data are not currently included in the Call Reports or other standard regulatory reports, to evaluate program success. *Pilot Study Application:* Volunteers for the pilot program will be screened to ensure that they meet certain basic eligibility requirements. A volunteer will likely be asked to demonstrate, by certification or otherwise, that it meets the following threshold requirements: A composite “1” or “2” rating on its most recent Safety and Soundness examination and a Management rating of “1” or “2”; satisfactory policies and procedures in all areas, including lending, audits, aggregate risk, internal controls, liquidity, interest rate risk, compliance, BSA/AML; a composite “1” or “2” rating on its most recent Compliance examination; at least a “Satisfactory” rating on its most recent Community Reinvestment Act

(CRA)evaluation; the fact that it is not currently subject to a formal or informal enforcement action or the subject of an investigation or inquiry. Each volunteer interested in participating in the study will also be asked to provide the following (or similar) information: • Whether it already offers small-dollar loans and, if so, the terms of such loans; • If it proposes to initiate a small-dollar loan program, the proposed structure of the program; • The current or proposed size of the program; • How it proposes to market the program; • How it envisions the small-dollar loan application process; • What it proposes as underwriting criteria; and • Proposed interest rates and fees. Key features of a preferred small-dollar lending program might include loan amounts of up to $1,000; amortization periods longer than a single pay cycle and up to 36 months for closed-end credit, or minimum payments which reduce principal ( *i.e.* , do not result in negative amortization) for open-end credit; annual percentage rates

(APR)below 36 percent; no prepayment penalties; origination and/or maintenance fees limited to the amount necessary to cover actual costs; and a savings component. Descriptions provided by eligible volunteers will be reviewed by a FDIC selection panel. To provide more meaningful information about the pilot's success, the institutions selected to participate will likely consist of various sized institutions and in widely dispersed geographic locations. *Program evaluation reports:* A volunteer must agree to the monitoring and data collection aspects of the pilot program. For this purpose, the FDIC anticipates that the following (or similar) information will be collected from participating institutions on a quarterly basis for two years: 1. Information about the loans in the Program a. The total number and total dollar amount of loans. b. Average loan term and average dollar size of loans. c. Average interest rates charged, average fees levied, and average calculations of APR (as required by the Truth-in-Lending Act). d. Aggregate delinquency, charge off, and workout refinancing data. 2. Information about the business value of the Program a. Profitability and/or break even data for the overall Program. b. Profitability of the overall customer relationship (especially if the customer migrated into other products) c. Information regarding whether customers of the Program migrated to other bank products. 3. Information about the benefit to consumers a. The total number and total dollar amount of linked savings accounts opened as part of the Program. b. Information as to duration and withdrawal rates of the linked savings accounts. c. Information regarding whether customers of the Program continued to use payday loans or other high-cost debt products. The preferred method for collecting these data is electronic submission through the existing FDIC *connect* data interface system to minimize burden on respondents, with participating institutions submitting the data within 40 calendar days of the end of each quarter. The study will conform to privacy rules and will not request any information that could be used to identify individual bank customers, such as name, address, or account number. All data from participating insured institutions will remain confidential. It is the intent of the FDIC to publish only general findings of the study. Benefits to Institutions Participating in the Pilot As indicated above, the study is being conducted on a volunteer basis. It is anticipated, however, that institutions participating in the study will realize some benefits. A state non-member bank that establishes a loan program that provides small, unsecured consumer loans that are consistent with the Affordable Small-Dollar Loan Guidelines would warrant favorable consideration by the FDIC under the CRA as an activity responsive to the credit needs of its community. It is anticipated that other institutions will also likely be entitled to similar favorable consideration after review by their primary federal regulator. Moreover, programs that transition low or moderate income borrowers from higher cost loans to lower cost loans are particularly responsive to community needs. Consequently, state non-member banks offering lower cost alternatives to such borrowers will also be viewed by the FDIC as particularly responsive in the CRA examination and similarly, other institutions upon review by their primary federal regulator. Where small-dollar loan products are combined with a low-cost savings account, institutions may also qualify for favorable consideration for providing community development services. Institutions can potentially use the small-dollar loan pilot to tap into new markets by expanding relationships with individuals who currently may not be fully utilizing the mainstream financial system. An intangible benefit that may accrue to institutions participating in the small-dollar pilot is the community goodwill that will likely be created as a result of offering consumers credit products with significant savings over payday loan fees. Request for Comment Comments are invited on:

(a)Whether the collection of information is necessary for the proper performance of the FDIC's functions, including whether the information has practical utility;

(b)the accuracy of the estimates of the burden of the information collection;

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

(d)ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology; and

(e)estimates of capital or start-up costs, and costs of operation, maintenance and purchase of services to provide the information. Dated at Washington, DC, this 1st day of June, 2007. Federal Deposit Insurance Corporation. Valerie J. Best, Assistant Executive Secretary. [FR Doc. E7-11005 Filed 6-6-07; 8:45 am] BILLING CODE 6714-01-P FEDERAL MARITIME COMMISSION Notice of Agreement Filed The Commission hereby gives notice of the filing of the following agreement 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.:* 011223-040. *Title:* Transpacific Stabilization Agreement. *Parties:* APL Co. PTE Ltd.; American President Lines, Ltd.; CMA-CGM S.A.; COSCO Container Lines Co., Ltd.; Evergreen Line Joint Service Agreement; Hanjin Shipping Co., Ltd.; Hapag-Lloyd AG; Hyundai Merchant Marine Co., Ltd.; Kawasaki Kisen Kaisha, Ltd.; Mediterranean Shipping Company S.A.; Mitsui O.S.K. Lines, Ltd.; Nippon Yusen Kaisha; Orient Overseas Container Line Limited; and Yangming Marine Transport Corp. *Filing Party:* David F. Smith, Esq.; Sher & Blackwell LLP; 1850 M Street, NW.; Suite 900; Washington, DC 20036. *Synopsis:* The amendment would expand the geographic scope of the agreement to include the Indian Subcontinent. Dated: June 4, 2007. By order of the Federal Maritime Commission. Bryant L. VanBrakle, Secretary. [FR Doc. E7-11059 Filed 6-6-07; 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 June 22, 2007. **A. Federal Reserve Bank of Atlanta** (David Tatum, Vice President) 1000 Peachtree Street, NE., Atlanta, Georgia 30309: *1. Heys Edward McMath, III* , Savannah, Georgia; to retain voting shares of First National Corporation, and thereby indirectly retain voting shares of First National Bank, both of Savannah, Georgia. **B. Federal Reserve Bank of St. Louis** (Glenda Wilson, Community Affairs Officer) 411 Locust Street, St. Louis, Missouri 63166-2034: *1. Wilson-Gardner Family Control Group* , Jackson, Mississippi, which consists of Fred Gillaspy Wilson, individually and as trustee of the Gardner Trust, Jackson, Mississippi; Rufus K. Gardner, Winona, Mississippi, and Joseph E. Gardner, Austin, Texas, as trustees of the Gardner Trust; Alice King Harrison, Forrest City, Arkansas; John Frederick Wilson, Jackson, Mississippi; Margaret Gardner Wilson, Ridgeland, Mississippi; Margaret Wilson Ethridge, Madison, Mississippi; Ermis King Wilson, Sterlington, Louisiana; Edna Earl Douglas, Memphis, Tennessee; Alison Wilson Page, Sterlington, Louisiana; and Ermis M. Wilson, Sterlington, Louisiana; to retain control of Commerce Bancorp, Inc., and thereby indirectly retain voting shares of Bank of Commerce, both of Greenwood, Mississippi. Board of Governors of the Federal Reserve System, June 4, 2007. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E7-11009 Filed 6-6-07; 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 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 Web site 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 July 3, 2007. **A. Federal Reserve Bank of Richmond** (A. Linwood Gill, III, Vice President) 701 East Byrd Street, Richmond, Virginia 23261-4528: *1. Bank of America Corporation* , Charlotte, North Carolina; to acquire 100 percent of the voting shares of ABN AMRO North America Holding Company, Chicago, Illinois, and thereby indirectly acquire voting shares of LaSalle Bank Corporation, Chicago, Illinois; LaSalle Bank Midwest National Assocation, Troy, Michigan; and LaSalle Bank National Association, Chicago, Illinois. Board of Governors of the Federal Reserve System, June 1, 2007. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E7-10916 Filed 6-6-07; 8:45 am] BILLING CODE 6210-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Toxicology Program

(NTP)Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Request for Ocular Irritancy Test Data From Human, Rabbit, and In Vitro Studies Using Standardized Testing Methods AGENCY: National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). ACTION: Request for submission of relevant data. SUMMARY: The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and NICEATM are collaborating with the European Centre for the Validation of Alternative Methods (ECVAM) to evaluate the validation status of *in vitro* test methods for assessing the ocular irritation potential of substances. On behalf of the ICCVAM, NICEATM requests data on substances tested for ocular irritancy in humans, rabbits, and/or in vitro. These data will be used to:

(1)Review the state-of-the-science in regard to the availability of accurate and reliable *in vitro* test methods for assessing the range of potential ocular irritation activity, including whether ocular damage is reversible or not and

(2)expand NICEATM's high-quality ocular toxicity database. *In vitro* test methods for which data are sought include, but are not limited to:

(1)The Bovine Corneal Opacity and Permeability

(BCOP)test,

(2)the Isolated Rabbit Eye

(IRE)test,

(3)the Isolated Chicken Eye

(ICE)test, and

(4)the Hen's Egg Test—Chorioallantoic Membrane (HET-CAM). DATES: Data should be received by July 23, 2007. Data received after this date will be considered as feasible. ADDRESSES: Dr. William S. Stokes, NICEATM Director, NIEHS, P.O. Box 12233, MD EC-17, Research Triangle Park, NC 27709,

(fax)919-541-0947, (e-mail) *niceatm@niehs.nih.gov.* *Courier address:* NICEATM, 79 T.W. Alexander Drive, Building 4401, Room 3128, Research Triangle Park, NC 27709. Responses can be submitted electronically at the ICCVAM-NICEATM Web site: *http://iccvam.niehs.nih.gov/contact/FR_pubcomment.htm* or by e-mail, mail, or fax. FOR FURTHER INFORMATION CONTACT: Other correspondence should be directed to Dr. William S. Stokes (919-541-2384 or *niceatm@niehs.nih.gov* ). SUPPLEMENTARY INFORMATION: Background In October 2003, the U.S. Environmental Protection Agency

(EPA)submitted to ICCVAM a nomination with several activities related to reducing, replacing, and refining the use of rabbits in the current *in vivo* eye irritation test method ( **Federal Register** Vol. 69, No. 57, pp 13859-13861, March 24, 2004). In response to this nomination, ICCVAM completed an evaluation of the validation status of the BCOP, ICE, IRE, and HET-CAM test methods for identifying severe (irreversible) ocular irritants/corrosives using the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (GHS), the EPA, and the European Union hazard classification systems. NICEATM and ICCVAM prepared a comprehensive background review document

(BRD)on each of the four *in vitro* test methods. Each BRD included an analysis of test method performance (i.e., reliability and relevance) as compared to the *in vivo* rabbit eye reference test method, based on all available data. ICCVAM developed recommendations on the usefulness and limitations of these *in vitro* test methods for identifying ocular corrosives/severe irritants after considering the BRDs, comments received from the public and the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM), and comments and recommendations received from an independent expert panel ( **Federal Register** Vol. 70, No. 53, pp 13513-13514, March 21, 2005 and Vol. 70, No. 211, p 66451, November 2, 2005). ICCVAM is now reviewing the validation status of these and other *in vitro* test methods for identifying nonsevere ocular irritants (i.e., those that induce reversible ocular damage) and non-irritants. Request for Data As part of the review process, NICEATM requests the submission of data from substances tested for ocular irritancy in humans, rabbits, and/or *in vitro* . Data received by July 23, 2007 will be compiled and added to the database maintained by NICEATM and utilized where appropriate in the evaluation of *in vitro* ocular irritation test methods. Data received after this date will also be considered and used where applicable for future evaluation activities. All information submitted in response to this notice will be made publicly available upon request to NICEATM. When submitting substance and protocol information/test data, please reference this **Federal Register** notice and provide appropriate contact information (name, affiliation, mailing address, phone, fax, e-mail, and sponsoring organization, as applicable). NICEATM prefers data to be submitted as copies of pages from study notebooks and/or study reports, if available. Raw data and analyses available in electronic format may also be submitted. Each submission for a substance should preferably include the following information, as appropriate: • Common and trade name. • Chemical Abstracts Service Registry Number (CASRN). • Chemical and/or product class. • Commercial source. • *In vitro* test protocol used. • Rabbit eye test protocol used. • Human eye test protocol used. • Individual animal/human or *in vitro* responses at each observation time (i.e., raw data). • The extent to which the study complied with national/international Good Laboratory Practice

(GLP)guidelines. • Date and testing organization. Additional information on the submission of data may be obtained at *http://iccvam.niehs.nih.gov/methods/ocutox/ivocutox.htm.* Background Information on ICCVAM and NICEATM ICCVAM is an interagency committee composed of representatives from 15 federal regulatory and research agencies that use or generate toxicological information. ICCVAM conducts technical evaluations of new, revised, and alternative methods with regulatory applicability and promotes the scientific validation and regulatory acceptance of toxicological test methods that more accurately assess the safety and hazards of chemicals and products and that refine, reduce, or replace animal use. The ICCVAM Authorization Act of 2000 (42 U.S.C. 285l-3, available at *http://iccvam.niehs.nih.gov/docs/about_docs/PL106545.pdf* ) established ICCVAM as a permanent interagency committee of the NIEHS under NICEATM. NICEATM administers the ICCVAM and provides scientific and operational support for ICCVAM-related activities. NICEATM and ICCVAM work collaboratively to evaluate new and improved test methods applicable to the needs of federal agencies. Additional information about ICCVAM and NICEATM is available on the following Web site: *http://iccvam.niehs.nih.gov.* Dated: May 25, 2007. Samuel H. Wilson, Deputy Director,National Institute of Environmental Health Sciences and National Toxicology Program. [FR Doc. E7-10966 Filed 6-6-07; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Institution for Occupational Safety and Health (NIOSH) Advisory Board on Radiation and Worker Health (ABRWH or Advisory Board) *Correction:* This notice was published in the **Federal Register** on May 22, 2007, Volume 72, Number 98, pages 28697-28698. The meeting was originally scheduled to be held at the Westin Westminster Hotel. The Committee will now convene at the Sheraton Denver West Hotel, 360 Union Boulevard, Lakewood, Colorado 80228, Phone 303.987.2000, Fax 303.969.0263. *Times and Dates:* 9 a.m.-5 p.m., June 11, 2007. 8 a.m.-3 p.m., June 12, 2007. *Contact Person for More Information:* Dr. Lewis V. Wade, Executive Secretary, NIOSH, CDC, 4676 Columbia Parkway, Cincinnati, Ohio 45226, Telephone 513.533.6825, Fax 513.533.6826. 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: May 31, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office Centers for Disease Control and Prevention. [FR Doc. E7-10987 Filed 6-6-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004D-0466] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substantiation for Dietary Supplement Claims Made Under the Federal Food, Drug, and Cosmetic Act AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a proposed collection of information has been submitted to the Office of Management and Budget

(OMB)for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by July 9, 2007. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974. All comments should be identified with the OMB control number “0910-NEW” and title, “Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act.” Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,301-827-4659. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act (OMB Control Number 0910-NEW) Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 343(r)(6))requires that a manufacturer of a dietary supplement making a nutritional deficiency, structure/function, or general well-being claim have substantiation that the statement is truthful and not misleading. The draft guidance document entitled “Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act” is intended to describe the amount, type, and quality of evidence FDA recommends a dietary supplement manufacturer have to substantiate a claim under section 403(r)(6) of the act. This guidance does not discuss the types of claims that can be made concerning the effect of a dietary supplement on the structure or function of the body, nor does it discuss criteria to determine when a statement about a dietary supplement is a disease claim. In the **Federal Register** of November 9, 2004 (69 FR 64962), FDA published a Notice of Availability of the draft guidance document with a 60-day notice requesting public comment on the collection of information provisions. We received a number of letters containing one or more comments, several of which responded to our request for comments on the proposed information collection. (Comment 1) Several comments challenged the accuracy of the estimated number of hours it would take to prepare the information needed to substantiate a claim when that claim is widely known and accepted. We estimated it would take 1 hour because supporting material for such claims should be readily available in textbooks and reference books. Two comments asserted that the burden estimate was too low but did not propose an alternative estimate or provide information to support a higher estimate. One comment did provide such information. Based on a review of how long it took to assemble the supporting information for approximately 50 claims involving products containing from 1 to 3 herbs, the comment stated that, for these claims, it took 18 to 24 hours to assemble the supporting information and an additional 2 to 4 hours to have a qualified expert review the information. In addition, the comment stated that, for products with more complicated formulations, it took approximately 40 hours plus the expert review time to assemble the supporting information. (Response) FDA has considered the information provided in the comment. Based on this information, we have increased our estimate of the burden of preparing the information needed to substantiate a claim on a dietary supplement when the claim is widely known and accepted from 1 hour to 44 hours. (Comment 2) One comment disagreed with our statement that there are no capital, operating, or maintenance costs associated with this collection of information. The comment stated that they use staff support, copying and scanning equipment, and electronic and hard copy file storage when preparing substantiation files. The comment also stated that there is a capital cost to maintain a botanical library collection of historical references and current scientific journals. Finally, it stated there is an on-going cost associated with reviewing scientific literature for new scientific developments. (Response) FDA believes that it is accurate to state that there are no capital, operating, or maintenance costs associated with this collection of information. Collecting the required information may generate some capital costs associated with using electronic equipment such as scanners and computers and using hard-copy file cabinets. However, we estimate that this cost is negligible because most firms probably already have this equipment, and the incremental cost of using this equipment for the purposes described would be very small. The few firms that do not own the necessary equipment could pay for access to scanners and computers for a minimal charge. Operating costs for this equipment would consist of the incremental cost of electricity for this equipment during the time it was used for the purposes described. Maintenance costs for this equipment would consist of the overall maintenance costs pro rated for the time the equipment was used for the purposes described. Both operating and maintenance costs would be minimal. Personnel costs associated with using this equipment have already been included as part of the burden hours that we presented in table 1 of this document. Further, we do not agree with the comment's assertion that a respondent would need to maintain a botanical library collection of historical references and current scientific journals. It is not necessary for a respondent to maintain a Botanical Library in order to access the requested information. In addition, the guidance does not recommend the firms continually update supporting material. We do not agree that the on-going cost of reviewing scientific literature for new scientific developments is a cost of this information collection. Therefore, FDA has not changed its assessment that there are no capital, operating, or maintenance costs associated with this collection of information. FDA estimates the burden for this information collection as follows: **Table 1.—Estimated Annual One-Time Reporting Burden** 1 Claim type No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours Widely known, established 667 1 667 44 29,348 Pre-existing, not widely established 667 1 667 120 80,040 Novel 667 1 667 120 80,040 Total 189,428 1 There are no capital costs associated with this collection of information. Dietary supplement manufacturers will only need to collect information to substantiate their product's nutritional deficiency, structure/function, or general well-being claim if they chose to place a claim on their product's label. Gathering evidence on their product's claim is a one time burden; they collect the necessary substantiating information for their product as required by section 403(r)(6) of the act. The standard discussed in the guidance for substantiation of a claim on the labeling of a dietary supplement is consistent with standards set by the Federal Trade Commission for dietary supplements and other health related products that the claim be based on competent and reliable scientific evidence. This evidence standard is broad enough that some dietary supplement manufacturers may only need to collect peer-reviewed scientific journal articles to substantiate their claims; other dietary supplement manufacturers whose products have properties that are less well documented may have to conduct studies to build a body of evidence to support their claims. It is unlikely that a dietary supplement manufacturer will attempt to make a claim when the cost of obtaining the evidence to support the claim outweighs the benefits of having the claim on the product's label. It is likely that manufacturers will seek substantiation for their claims in the scientific literature. The time it takes to assemble the necessary scientific information to support their claims depends on the product and the claimed benefits. If the product is one of several on the market making a particular claim for which there is adequate publicly available and widely established evidence supporting the claim, then the time to gather supporting data will be minimal; if the product is the first of its kind to make a particular claim or the evidence supporting the claim is less publicly available or not widely established, then gathering the appropriate scientific evidence to substantiate the claim will be more time consuming. FDA assumes that it will take 44 hours to assemble information needed to substantiate a claim on a particular dietary supplement when the claim is widely known and established. We increased this estimated burden from 1 hour per claim to 44 hours per claim based on information received from industry, as noted in our response to comment 1. FDA believes it will take closer to 120 hours to assemble supporting scientific information when the claim is novel or when the claim is pre-existing but the scientific underpinnings of the claim are not widely established. These are claims that may be based on emerging science, where conducting literature searches and understanding the literature takes time. It is also possible that references for claims made for some dietary ingredients or dietary supplements may primarily be found in foreign journals and in foreign languages or in the older, classical literature where it is not available on computerized literature databases or in the major scientific reference databases, such as the National Library of Medicine's literature database, all of which increases the time of obtaining substantiation. In the final rule on statements made for dietary supplements concerning the effect of the product on the structure or function of the body (structure/function final rule (65 FR 1000, January 6, 2000)), FDA estimated that there were 29,000 dietary supplement products marketed in the United States (65 FR 1000 at 1045). Assuming that the flow of new products is 10 percent per year, then 2,900 new dietary supplement products will come on the market each year. The structure/function final rule estimated that about 69 percent of dietary supplements have a claim on their labels, most probably a structure/function claim (65 FR 1000 at 1046). Therefore, we assume that supplement manufacturers will need time to assemble the evidence to substantiate each of the 2,001 claims (2,900 x 69 percent) made each year. If we assume that the 2,001 claims are equally likely to be pre-existing widely established claims, novel claims, or pre-existing claims that are not widely established, then we can expect 667 of each of these types of claims to be substantiated per year. Table 1 of this document shows that the annual burden hours associated with assembling evidence for claims is 189,428 (the sum of 667 x 44 hours, 667 x 120 hours, and 667 x 120 hours). There are no capital costs or operating and maintenance costs associated with this information collection. Dated: May 31, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-10911 Filed 6-6-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006P-0201] Determination That CEFOTAN (Cefotetan Disodium For Injection), Equivalent 1 Gram Base/Vial and 2 Grams Base/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)has determined that CEFOTAN (cefotetan disodium for injection), equivalent 1 gram

(g)base/vial and 2 g base/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for cefotetan disodium for injection, equivalent 1 g base/vial and 2 g base/vial, if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Nam Kim, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5515 Security Lane, Rockville, MD 20852, 301-443-5537. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA sponsors must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is typically a version of the drug that was previously approved. Sponsors of ANDAs do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The only clinical data required in an ANDA are data to show that the drug that is the subject of the ANDA is bioequivalent to the listed drug. The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is generally known as the “Orange Book.” Under FDA regulations, drugs are withdrawn from the list if the agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). Under 21 CFR 314.161(a)(1), the agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness before an ANDA that refers to that listed drug may be approved. FDA may not approve an ANDA that does not refer to a listed drug. CEFOTAN (cefotetan disodium for injection), equivalent 1 g base/vial and 2 g base/vial, is the subject of approved NDA 50-588 held by AstraZeneca Pharmaceuticals LP (AstraZeneca). CEFOTAN (cefotetan disodium for injection) is indicated for the therapeutic treatment of urinary tract infections, lower respiratory tract infections, skin and skin structure infections, gynecologic infections, intra-abdominal infections, and bone and joint infections when caused by susceptible strains of the designated organisms described in the labeling. FDA approved the NDA for CEFOTAN (cefotetan disodium for injection), equivalent 1 g base/vial and 2 g base/vial, on December 27, 1985. Beginning with the October 2006 update, FDA has listed CEFOTAN (cefotetan disodium for injection), equivalent 1 g base/vial and 2 g base/vial, in the “Discontinued Drug Product List” of the Orange Book because AstraZeneca notified FDA that the product was no longer marketed. B. Braun Medical Inc., submitted a citizen petition dated May 10, 2006 (Docket No. 2006P-0201/CP1), under 21 CFR 10.30, requesting that the agency determine whether CEFOTAN (cefotetan disodium for injection), equivalent 1 g base/vial and 2 g base/vial (NDA 50-588) was withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition (including comments submitted) and reviewing agency records, FDA has determined that CEFOTAN (cefotetan disodium for injection), equivalent 1 g base/vial and 2 g base/vial, was not withdrawn from sale for reasons of safety or effectiveness. The petitioner identified no data or other information suggesting that CEFOTAN (cefotetan disodium for injection), equivalent 1 g base/vial and 2 g base/vial, was withdrawn from sale as a result of safety or effectiveness concerns. FDA has independently evaluated relevant literature and data for adverse event reports and has found no information that would indicate that CEFOTAN (cefotetan disodium for injection), equivalent 1 g base/vial and 2 g base/vial, was withdrawn for reasons of safety or effectiveness. For the reasons outlined in this document, FDA determines that CEFOTAN (cefotetan disodium for injection), equivalent 1 g base/vial and 2 g base/vial, was not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the agency will continue to list CEFOTAN (cefotetan disodium for injection), equivalent 1 g base/vial and 2 g base/vial, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to CEFOTAN (cefotetan disodium for injection), equivalent 1 g base/vial and 2 g base/vial, may be approved by the agency as long as they meet all relevant legal and regulatory requirements for approval of ANDAs. If FDA determines that labeling for these drug products should be revised to meet current standards, the agency will advise ANDA applicants to submit such labeling. Dated: May 31, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-10959 Filed 6-6-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. 2007M-0109, 2007M-0006, 2007M-0007, 2007M-0032, 2007M-0049, 2007M-0038, 2007M-0058, 2007M-0086, 2007M-0107, 2007M-0084, 2007M-0108] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is publishing a list of premarket approval applications

(PMAs)that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management. ADDRESSES: Submit written requests for copies of summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Please cite the appropriate docket number as listed in table 1 of this document when submitting a written request. See the SUPPLEMENTARY INFORMATION section for electronic access to the summaries of safety and effectiveness. FOR FURTHER INFORMATION CONTACT: Thinh Nguyen, Center for Devices and Radiological Health (HFZ-402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4010, ext. 152. SUPPLEMENTARY INFORMATION: I. Background In the **Federal Register** of January 30, 1998 (63 FR 4571), FDA published a final rule that revised 21 CFR 814.44(d) and 814.45(d) to discontinue individual publication of PMA approvals and denials in the **Federal Register** . Instead, the agency now posts this information on the Internet on FDA's home page at *http://www.fda.gov* . FDA believes that this procedure expedites public notification of these actions because announcements can be placed on the Internet more quickly than they can be published in the **Federal Register** , and FDA believes that the Internet is accessible to more people than the **Federal Register** . In accordance with section 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(d)(4) and (e)(2)), notification of an order approving, denying, or withdrawing approval of a PMA will continue to include a notice of opportunity to request review of the order under section 515(g) of the act. The 30-day period for requesting reconsideration of an FDA action under § 10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a PMA begins on the day the notice is placed on the Internet. Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period. Reconsideration of a denial or withdrawal of approval of a PMA may be sought only by the applicant; in these cases, the 30-day period will begin when the applicant is notified by FDA in writing of its decision. The regulations provide that FDA publish a quarterly list of available safety and effectiveness summaries of PMA approvals and denials that were announced during that quarter. The following is a list of approved PMAs for which summaries of safety and effectiveness were placed on the Internet from January 1, 2007, through March 31, 2007. There were no denial actions during this period. The list provides the manufacturer's name, the product's generic name or the trade name, and the approval date. **Table 1.—List of Safety and Effectiveness Summaries for Approved PMAs Made Available From January 1, 2007, through March 31, 2007** PMA No./Docket No. Applicant Trade Name Approval Date P040051/2007M-0109 Stelkast Co. STELKAST SURPASS ACETABULAR SYSTEM May 12, 2006 P050037/2007M-0006 Bioform Medical, Inc. RADIESSE 1.3 CC AND 0.3 CC December 22, 2006 P050052/2007M-0007 Bioform Medical, Inc. RADIESSE 1.3 CC AND 0.3 CC December 22, 2006 P050018/2007M-0032 Angioscore, Inc. ANGIOSCULPT SCORING BALLOON CATHETER January 8, 2007 P060001/2007M-0049 EV3, Inc. PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMS January 24, 2007 H060004/2007M-0038 Fujirebio Diagnostics, Inc. FUJIREBIO MESOMARK ASSAY January 24, 2007 P050007(S1)/2007M-0058 Abbott Vascular Devices STARCLOSE VASCULAR CLOSURE SYSTEM February 2, 2007 P050013/2007M-0086 Tissue Seal, LLC. HISTOACRYL & HISTOACRYL BLUE TOPICAL SKIN ADHESIVE February 16, 2007 P980022(S15)/2007M-0107 Medtronic Minimed GUARDIAN RT & PARADIGM REAL-TIME CONTIUOUS GLUCOSE MONITORING SYSTEMS March 8, 2007 P050053/2007M-0084 Medtronic Sofamor Danek USA, Inc. INFUSE BONE GRAFT March 9, 2007 P060019/2007M-0108 Irvine Biomedical, Inc. IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF ABLATION GENERATOR March 16, 2007 II. Electronic Access Persons with access to the Internet may obtain the documents at *http://www.fda.gov/cdrh/pmapage.html* . Dated: May 24, 2007. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E7-11002 Filed 6-6-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0208] Science Board to the Food and Drug Administration; 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 Science Board to the Food and Drug Administration (Science Board). This meeting was originally announced in the **Federal Register** of May 21, 2007 (72 FR 28499). The amendment is being made to reflect a change in the *Agenda* and *Procedure* portions of the document. There are no other changes. FOR FURTHER INFORMATION CONTACT: Carlos Peña, Office of the Commissioner, Food and Drug Administration (HF-33), 5600 Fishers Lane, Rockville, Maryland, 20857, 301-827-6687, *carlos.peña@fda.hhs.gov* , or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512603. Please call the Information Line for up-to-date information on this meeting. SUPPLEMENTARY INFORMATION: In the **Federal Register** of May 21, 2007, FDA announced that a meeting of the Science Board would be held on June 14, 2007. On page 28499, in the second and third columns, the *Agenda* and *Procedure* portions of document are amended to read as follows: *Agenda* : The Science Board will hear about and discuss the agency's bioinformatics initiative and fellowship program. The Science Board will hear about and review the scientific validity of the agency's “Interim Melamine and Analogues Safety/Risk Assessment” ( *http://www.cfsan.fda.gov/~lrd/fr070530.html* , Docket No. 2007N-0208). The Science Board will then continue its discussion of the review of both the agency's science programs and the National Antimicrobial Resistance Monitoring System (NARMS) Program, from the March 31, 2006, Science Board meeting. Discussions will first include a subcommittee update to the Science Board on the progress of the review of the agency's science programs. The Science Board will then hear about and discuss the subcommittee review of the NARMS Program including the public meeting regarding the NARMS Program on April 10, 2007, and subsequent deliberations. *Procedure* : Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. We are extending the written submission deadline based upon the amended **Federal Register** notice. Written submissions may be made to the contact person on or before June 9, 2007. Two oral presentations from the public will be scheduled between approximately 10:45 a.m. and 11:45 p.m., and 3:15 p.m. and 4:15 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 June 9, 2007. 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 sessions. The contact person will notify interested persons regarding their request to speak by June 9, 2007. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app.2) and 21 CFR part 14, relating to the advisory committees. Dated: June 1, 2007. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. 07-2829 Filed 6-4-07; 11:10 am]

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