Notices. Notice

8,420 words·~38 min read·/register/2008/02/25/08-815·

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

BILLING CODE 6712-07-M FEDERAL COMMUNICATIONS COMMISSION [WT Docket No. 08-20; DA 08-361] William F. Crowell, Application To Renew License for Amateur Radio Service Station W6WBJ AGENCY: Federal Communications Commission. ACTION: Notice. SUMMARY: In this document, the Commission initiates a hearing proceeding before a Commission Administrative Law Judge to determine whether an application to renew the license for Amateur Radio Service Station W6WBJ filed by William F. Crowell should be granted.

DATES: The document was mailed to the party on February 13, 2007. ADDRESSES: Federal Communications Commission, 445 12th St., SW., Washington, DC 20554. FOR FURTHER INFORMATION CONTACT: Gary Schonman, Enforcement Bureau, at *Gary.Schonman@fcc.gov* or

(202)418-1795 or TTY

(202)418-1152. SUPPLEMENTARY INFORMATION: This is a summary of the *Hearing Designation Order* in WT Docket No. 08-20, DA 08-361, adopted by the Commission's Wireless Telecommunications Bureau on February 12, 2007, and released on February 12, 2007. The full text of this document is available for inspection and copying during normal business hours in the FCC Reference Center, 445 12th Street, SW., Washington, DC 20554. The complete text may be purchased from the Commission's copy contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20554. The full text may also be downloaded at: *http://www.fcc.gov.* Alternative formats are available to persons with disabilities by sending an e-mail to *fcc504@fcc.gov* or by calling the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (tty). Synopsis of the Order 1. In this *Hearing Designation Order,* the Commission commences a hearing proceeding before a Commission Administrative Law Judge to determine whether the above-captioned application filed by William F. Crowell for renewal of his license for Amateur Radio Station W6WBJ should be granted. As discussed below, the record before us indicates that Castle has apparently willfully and repeatedly engaged in unlawful Commission-related activities, including, but not limited to, intentionally causing interference; transmitting music and one-way communications; and using slanderous, harassing, and indecent language on amateur frequencies. Based on the information before us, we believe that Crowell's apparent continuing course of misconduct raises a substantial and material question of fact as to whether he possesses the requisite character qualifications to be and remain a Commission licensee. Accordingly, we hereby designate his application for hearing. 2. Pursuant to sections 4(i) and 309(e) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), and 309(e), the captioned application is designated for hearing in a proceeding before an FCC Administrative Law Judge, at a time and place to be specified in a subsequent *Order,* upon the following issues:

(a)To determine whether William F. Crowell willfully and/or repeatedly violated Section 333 of the Communications Act of 1934, as amended, and § 97.101(d) of the Commission's rules, by intentionally interfering with radio communications;

(b)To determine whether William F. Crowell willfully and/or repeatedly violated § 97.113(b) of the Commission's rules by transmitting one-way communications on amateur frequencies;

(c)To determine whether William F. Crowell willfully and/or repeatedly violated § 97.113(a)(4) of the Commission's rules by transmitting indecent language;

(d)To determine whether William F. Crowell willfully and/or repeatedly violated § 97.113(a)(4) of the Commission's rules by transmitting music;

(e)To determine, in light of the evidence adduced pursuant to the foregoing issues, whether William F. Crowell is qualified to be and remain a Commission licensee;

(f)To determine, in light of the evidence adduced pursuant to the foregoing issues, whether the captioned application filed by William F. Crowell should be granted. 3. Pursuant to section 4(i) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), and § 1.221(c) of the Commission's rules, 47 CFR 1.221(c), in order to avail himself of the opportunity to be heard, William F. Crowell, in person or by his attorney, shall file with the Commission, within twenty calendar days of the mailing of this *Hearing Designation Order* to him, a written appearance stating that he will appear on the date fixed for hearing and present evidence on the issues specified herein. 4. Pursuant to § 1.221(c) of the Commission's rules, 47 CFR 1.221(c), if William F. Crowell fails to file a written appearance within the twenty-day period, or has not filed prior to the expiration of the twenty-day period, a petition to dismiss without prejudice, or a petition to accept, for good cause shown, a written appearance beyond the expiration of the twenty-day period, the Presiding Administrative Law Judge shall dismiss the captioned application with prejudice for failure to prosecute. 5. The Chief, Enforcement Bureau, shall be made a party to this proceeding without the need to file a written appearance. 6. Pursuant to sections 4(i) and 309(e) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), and 309(e), the burden of proceeding with the introduction of evidence and the burden of proof with respect to all of the issues specified above shall be on William F. Crowell. 7. A copy of this *Hearing Designation Order* or a summary thereof shall be published in the **Federal Register** . 8. This action is taken under delegated authority pursuant to §§ 0.131 and 0.331 of the Commission's rules, 47 CFR 0.131, and 0.331. Federal Communications Commission. Scot Stone, Deputy Chief, Mobility Division. [FR Doc. E8-3346 Filed 2-22-08; 8:45 am] BILLING CODE 6712-01-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 (44 U.S.C. chapter 35), 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 establishing a generic information collection to conduct occasional qualitative surveys in support of Alliance for Economic Inclusion

(AEI)initiatives. The subject matter of the surveys would be determined by individual AEI regional area needs and areas of interest, but likely would include such topics as financial literacy education, asset building programs, retail banking services, and alternative financial services delivery channels. Survey respondents would typically include AEI coalition member financial institutions, but may also include non-AEI member financial institutions in regional areas served by AEIs. Depending on local needs, other organizations could also be surveyed as well. DATES: Comments must be submitted on or before April 25, 2008. ADDRESSES: Interested parties are invited to submit written comments by mail to Leneta Gregorie, Legal Division, Federal Deposit Insurance Corporation, 550 17th Street, NW., Washington, DC 20429; by FAX at

(202)898-8788; or by e-mail to *comments@fdic.gov.* All comments should refer to “Alliance for Economic Inclusion

(AEI)Occasional Qualitative Surveys.” 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. FOR FURTHER INFORMATION CONTACT: Interested members of the public may obtain additional information about the collection 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:* Alliance for Economic Inclusion

(AEI)Occasional Qualitative Surveys. *OMB Number:* New collection (3064-xxxx). *Frequency of Response:* Occasional. *Affected Public:* Primarily insured financial institutions in areas served by AEI coalitions, although other organizations could also be surveyed as well. *Estimated Number of Respondents:* Up to 90 per collection. *Estimated time per response:* Up to 1 hour per respondent. *Estimated Total Annual Burden:* 90 respondents × 20 collections per year × 1 hour per response = 1,800 hours. General Description of Collection The AEI is a national initiative sponsored by the FDIC to help improve the economic well-being of low- and moderate-income individuals and families by improving their access to the U.S. banking system. To facilitate this effort, AEI has established broad-based coalitions of financial institutions, community- and faith-based organizations, state, and local governmental agencies, federal bank regulators, researchers, employers, and bank trade associations in various markets across the country to focus on the basic retail financial services needs of unbanked and underserved populations in their respective areas. Currently, there are nine AEI coalitions, one each focusing on: The “Black Belt” semi-rural area of Alabama; the greater Boston/Worcester area; the city of Chicago; the Austin/South Texas, Texas area; the Kansas City metropolitan area; the Louisiana and Mississippi Gulf Coast areas; the Baltimore, Maryland area; the Wilmington, Delaware area; and the city of Los Angeles. However, additional coalition(s) may be formed in the future. Each regional AEI has formed working groups to identify barriers and opportunities and works independently to develop innovative products and marketing strategies to bring the unbanked and underserved into the financial mainstream. Such products and strategies might include low-cost deposit accounts, low- or no-cost check cashing, affordable remittance products, free tax preparation, individual development accounts, coaching or other counseling assistance, and financial education. The purpose of surveys submitted to OMB under this generic information collection would be in furtherance of the objectives of the AEI working groups. A sample survey, proposed for use by the Wilmington AEI coalition, appears in Appendix A. Although the members of each AEI initiative, rather than the FDIC, will be primarily responsible for developing survey contents, the FDIC does facilitate AEI initiatives by providing support services. Therefore, any AEI surveys would be conducted by the FDIC using its own staff and resources. Technology will be used to the extent it is cost effective and possible to electronically distribute survey instruments and collect survey data. In addition, the FDIC will ensure that AEI surveys are consistent with rules governing federally conducted or sponsored information collections, conform to privacy rules, and do not request any information of a sensitive nature. It is not the intent of the FDIC to publish survey findings. All data from the surveys are for the information and use of the sponsoring AEI coalition. 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. Appendix A— Proposed Survey of Retail Bank Services in Wilmington 1. Does your Bank offer in-house financial literacy education centrally, at your branches or provide funding to 3rd parties for this service? Yes _ No_ If yes, please indicate if you offer multi-lingual education and locations: 2. Does your Bank offer banking products and services using multi-lingual marketing and promotional materials? a. ATM; Bank by Phone; Internet Banking; Teller Services; New Loan Accounts; New Deposit Accounts If yes, please indicate the languages and specific services you provide: 3. Does your bank offer bilingual banking literature and/or services? Yes _ No_ If yes, please list available literature and language(s): 4. Does your bank offer free checking with no minimum account opening balance requirement? Yes _ No_ If yes, please indicate any fees and/or requirements: 5. Does your bank offer other low cost deposit products? Yes _ No_ If yes please describe the products: 6. Does your bank offer low cost money orders? Yes _ No_ If yes, please indicate any fees and/or requirements: 7. Does your bank offer bill payment options at branches (such as payment of utility bills)? Yes _ No_ If yes, please indicate any fees and/or requirements associated with this service: 8. Does your bank offer prepaid products? Yes _ No_ If yes, please describe the products offered and indicate if there are associated fees: 9. Does your bank offer discounted first time home buyers mortgages either directly or through a 3rd party? Yes _ No_ If yes, please describe the programs, including but not limited to any grants, waived fees, interest buy down, participation with local and state communities: 10. What type of secured loan and secured credit line products does your bank offer? 11. Does your bank participate in an Outreach Program? Yes _ No_ If yes, please describe the program(s): 12. Does your bank offer international remittance services? Yes _ No_ a) List any outgoing fees/incoming fees and/or requirements:

(b)List any other specialized remittance services (such as ATM/debit-cards): 13. What form(s) of identification are required for new accounts under your Customer Identification Program?

(a)List accepted form(s) of ID for U.S. persons:

(b)List accepted form(s) of ID for non-U.S. persons:

(c)How many forms of ID are required (indicate picture or non-picture)?

(d)If applicable, please list any * non- documentary methods * that are used to identify customers. 14. Does your bank accept consular cards for ID (such as the Mexican matricula consular)? Yes _ No_ If yes, please specify which country(s) consular cards you accept: 15. Does your bank provide assistance with ITIN? Yes _ No_ If yes, please describe any assistance that you provide (such as providing W7 forms): 16. Does your bank use an account or credit history check when opening up checking accounts? Yes__ No__ If yes, please indicate which service you utilize: CheckSystems:__ TeleCheck:__ Credit Bureau:__ Other:__ 17. Does your bank participate in the Delaware EITC program? If yes, what special products and/or services do you offer unbanked recipients of refunds under the program? 18. Please list any other services available at your bank that you feel may be applicable to this survey. 19. Please feel free to add any comments/suggestions concerning any challenges your bank has encountered when trying to serve the under-served customers such as immigrants (include suggestions for regulatory guidance). Survey completed by: Contact information: Thank you very much for your assistance and cooperation. Please fax the completed form to: (Title and Name) at (Phone Number) or e-mail the completed form to (e-mail address) Dated at Washington, DC, this 19th day of February, 2008. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary. [FR Doc. E8-3377 Filed 2-22-08; 8:45 am] BILLING CODE 6714-01-P 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 *http://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 March 21, 2008. **A. Federal Reserve Bank of Kansas City** (Todd Offenbacker, Assistant Vice President) 925 Grand Avenue, Kansas City, Missouri 64198-0001: *1. FBHC Holding Company* , to become a bank holding company by acquiring 100 percent of the voting shares of FlatIrons Bank Holding Company, and thereby acquire FlatIrons Bank, all of Boulder, Colorado. Board of Governors of the Federal Reserve System, February 20, 2008. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E8-3458 Filed 2-22-08; 8:45 am] BILLING CODE 6210-01-S FEDERAL TRADE COMMISSION [File No. 051 0094] Negotiated Data Solutions LLC; Analysis of Proposed Consent Order to Aid Public Comment AGENCY: Federal Trade Commission. ACTION: Extension of deadline for submission of public comments. SUMMARY: The Federal Trade Commission is extending the deadline for filing public comments in connection with the consent agreement in this matter, which settles alleged violations of federal law prohibiting unfair or deceptive acts or practices and unfair methods of competition. DATES: Public comments must be received on or before April 24, 2008. ADDRESSES: Interested parties are invited to submit written comments. Comments should refer to ‘‘Negotiated Data Solutions, File No. 051 0094,’’ to facilitate the organization of comments. A comment filed in paper form should include this reference both in the text and on the envelope, and should be mailed or delivered to the following address: Federal Trade Commission/Office of the Secretary, Room 135-H (Annex D), 600 Pennsylvania Avenue, NW, Washington, D.C. 20580. Comments containing confidential material must be filed in paper form, must be clearly labeled “Confidential,” and must comply with Commission Rule 4.9(c). 16 CFR 4.9(c) (2005). 1 The FTC is requesting that any comment filed in paper form be sent by courier or overnight service, if possible, because U.S. postal mail in the Washington area and at the Commission is subject to delay due to heightened security. Comments that do not contain any nonpublic information may instead be filed in electronic form by following the instructions on the web-based form at *http://secure.commentworks.com/ftc-NegotiatedDataSolutions.* To ensure that the Commission considers an electronic comment, you must file it on that web-based form. The FTC Act and other laws the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. All timely and responsive public comments, whether filed in paper or electronic form, will be considered by the Commission, and will be available to the public on the FTC website, to the extent practicable, at *www.ftc.gov.* As a matter of discretion, the FTC makes every effort to remove home contact information for individuals from the public comments it receives before placing those comments on the FTC website. More information, including routine uses permitted by the Privacy Act, may be found in the FTC’s privacy policy, at *http://www.ftc.gov/ftc/privacy.htm.* 1 The comment must be accompanied by an explicit request for confidential treatment, including the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record. The request will be granted or denied by the Commission’s General Counsel, consistent with applicable law and the public interest. *See* Commission Rule 4.9(c), 16 CFR 4.9(c). FOR FURTHER INFORMATION CONTACT: Kent E. Cox

(202)326-2058, Bureau of Competition, Room NJ-6213, 600 Pennsylvania Avenue, NW, Washington, D.C. 20580. SUPPLEMENTARY INFORMATION: On January 23, 2008, pursuant to section 6(f) of the Federal Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46(f), and § 2.34 of the Commission Rules of Practice, 16 CFR 2.34, the Commission gave notice that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, had been placed on the public record for a period of thirty

(30)days, and published a Notice to that effect in the Federal Register. *See* 73 Fed. Reg. 5,846 (Jan. 31, 2008). The Notice also designated February 22, 2008, as the deadline for filing public comments. A number of prospective commenters have now requested an extension of the public comment period, in order to ensure that they will be able to provide the Commission with the best information available. In light of the number and importance of the issues on which it has requested comment, the Commission has determined to extend the filing deadline until April 24, 2008. By direction of the Commission. Donald S. Clark Secretary. [FR Doc. E8-3556 Filed 2-22-08: 8:45 am] [BILLING CODE 6750-01-S] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0094] Agency Information Collection Activities; Proposed Collection; Comment Request; Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA's guidance for industry entitled “Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations.” DATES: Submit written or electronic comments on the collection of information by April 25, 2008. ADDRESSES: Submit electronic comments on the collection of information to *http://www.regulations.gov* . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget

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

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

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

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

(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations (OMB Control Number 0910-0562)—Extension The Food Quality Protection Act of 1996 (FQPA), which amended the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (the act), established a new safety standard for pesticide residues in food, with an emphasis on protecting the health of infants and children. The Environmental Protection Agency

(EPA)is responsible for regulating the use of pesticides (under FIFRA) and for establishing tolerances or exemptions from the requirement for tolerances for residues of pesticide chemicals in food commodities (under the act). EPA, in accordance with the FQPA, is in the process of reassessing the pesticide tolerances and exemptions which were in effect when the FQPA was signed into law. When EPA determines that a pesticide's tolerance level does not meet the safety standard under section 408 of the act (21 U.S.C. 346a), the registration for the pesticide may be canceled under FIFRA for all or certain uses. In addition, the tolerances for that pesticide may be lowered or revoked for the corresponding food commodities. Under section 408(l)(2) of the act, when the registration for a pesticide is canceled or modified due to, in whole or in part, dietary risks to humans posed by residues of that pesticide chemical on food, the effective date for the revocation of such tolerance (or exemption in some cases) must be no later than 180 days after the date such cancellation becomes effective or 180 days after the date on which the use of the canceled pesticide becomes unlawful under the terms of the cancellation, whichever is later. When EPA takes such actions, food derived from a commodity that was lawfully treated with the pesticide may not have cleared the channels of trade by the time the revocation or new tolerance level takes effect. The food could be found by FDA, the agency that is responsible for monitoring pesticide residue levels and enforcing the pesticide tolerances in most foods (the U.S. Department of Agriculture

(USDA)has responsibility for monitoring residue levels and enforcing pesticide tolerances in egg products and most meat and poultry products), to contain a residue of that pesticide that does not comply with the revoked or lowered tolerance. FDA would normally deem such food to be in violation of the law by virtue of it bearing an illegal pesticide residue. The food would be subject to FDA enforcement action as an “adulterated” food. However, the channels of trade provision of the act (section 408(l)(5) of the act) addresses the circumstances under which a food is not unsafe solely due to the presence of a residue from a pesticide chemical for which the tolerance has been revoked, suspended, or modified by EPA. The channels of trade provision states that food containing a residue of such a pesticide shall not be deemed “adulterated” by virtue of the residue, if the residue is within the former tolerance, and the responsible party can demonstrate to FDA's satisfaction that the residue is present as the result of an application of the pesticide at a time and in a manner which were lawful under FIFRA. In the **Federal Register** of May 18, 2005 (70 FR 28544), FDA announced the availability of a guidance document entitled, “Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations.” The guidance represents the agency's current thinking on its planned enforcement approach to the channels of trade provision of the act and how that provision relates to FDA-regulated products with residues of pesticide chemicals for which tolerances have been revoked, suspended, or modified by EPA under dietary risk considerations. The guidance can be found at *http://www.cfsan.fda.gov/guidance.html* . FDA anticipates that food bearing lawfully applied residues of pesticide chemicals that are the subject of future EPA action to revoke, suspend, or modify their tolerances, will remain in the channels of trade after the applicable tolerance is revoked, suspended, or modified. If FDA encounters food bearing a residue of a pesticide chemical for which the tolerance has been revoked, suspended, or modified, it intends to address the situation in accordance with provisions of the guidance. In general, FDA anticipates that the party responsible for food found to contain pesticide chemical residues (within the former tolerance) after the tolerance for the pesticide chemical has been revoked, suspended, or modified will be able to demonstrate that such food was handled, e.g., packed or processed, during the acceptable timeframes cited in the guidance by providing appropriate documentation to the agency as discussed in the guidance document. FDA is not suggesting that firms maintain an inflexible set of documents where anything less or different would likely be considered unacceptable. Rather, the agency is leaving it to each firm's discretion to maintain appropriate documentation to demonstrate that the food was so handled during the acceptable timeframes. Examples of documentation which FDA anticipates will serve this purpose consist of documentation associated with packing codes, batch records, and inventory records. These are types of documents that many food processors routinely generate as part of their basic food-production operations. FDA is requesting the extension of OMB approval for the information collection provisions in the guidance. *Description of Respondents* : The likely respondents to this collection of information are firms in the produce and food-processing industries that handle food products that may contain residues of pesticide chemicals after the tolerances for the pesticide chemicals have been revoked, suspended, or modified. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 Activity No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours Submission of documentation 1 1 1 3 3 1 There are no capital costs or operating and maintenance costs associated with this collection of information. FDA expects the total number of pesticide tolerances that are revoked, suspended, or modified by EPA in the next 3 years to significantly decrease, as EPA concludes its review activity. Thus, the above estimates for respondents and numbers of responses in table 1 of this document are based on the submissions that the agency has received in the past 3 years and the expectation that the number of submissions will significantly decrease in the next 3 years. However, to avoid counting this burden as zero, FDA has estimated the burden at one respondent making one submission a year for a total of one annual submission. The hours per response values were estimated as follows: First, we assumed that the information requested in this guidance is readily available to the submitter. We expect that the submitter will need to gather information from appropriate persons in the submitter's company and to prepare this information for submission to FDA. The submitter will almost always merely need to copy existing documentation. We believe that this effort should take no longer than 3 hours per submission. **Table 2.—Estimated Annual Recordkeeping Burden** 1 Activity No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Records Hours per Record Total Hours Develop documentation process 1 1 1 16 16 1 There are no capital costs or operating and maintenance costs associated with this collection of information. In determining the estimated annual recordkeeping burden, FDA estimated that at least 90 percent of firms maintain documentation, such as packing codes, batch records, and inventory records, as part of their basic food production or import operations. Therefore, the recordkeeping burden was calculated as the time required for the 10 percent of firms that may not be currently maintaining this documentation to develop and maintain documentation, such as batch records and inventory records. In previous information collection requests, this recordkeeping burden was estimated to be 16 hours. Although FDA estimates that only 1 out of 10 firms will not be currently maintaining the necessary documentation, to avoid counting the recordkeeping burden for the one submission per year as zero, FDA has retained its prior estimate of 16 hours for the recordkeeping burden. Please note that on January 15, 2008, the FDA Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic submissions will be accepted by FDA through FDMS only. Dated: February 15, 2008. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E8-3415 Filed 2-22-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-C-0098] Combe, Inc.; Filing of Color Additive Petition AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that Combe, Inc., has filed a petition proposing that the color additive regulations be amended to increase the permitted use level of bismuth citrate as a color additive in cosmetics intended for coloring hair on the scalp. DATES: Submit written or electronic comments on the petitioner's environmental assessment by March 26, 2008. ADDRESSES: Submit written comments 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.regulations.gov* . FOR FURTHER INFORMATION CONTACT: Felicia M. Ellison, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1264. SUPPLEMENTARY INFORMATION: Under section 721e(d)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379e(d)(1)), notice is given that a color additive petition (CAP 8C0286) has been filed by Combe, Inc., c/o EAS Consulting Group, LLC, 1940 Duke St., suite 200, Alexandria, VA 22314. The petition proposes to amend the color additive regulations in § 73.2110 *Bismuth citrate* (21 CFR 73.2110) to increase the permitted use level of bismuth citrate as a color additive in cosmetics intended for coloring hair on the scalp. The potential environmental impact of this action is being reviewed. To encourage public participation consistent with regulations issued under the National Environmental Policy Act (40 CFR 1501.4(b)), the agency is placing the environmental assessment submitted with the petition that is the subject of this notice on public display at the Division of Dockets Management (see ADDRESSES ) for public review and comment. Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. 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. FDA will also place on public display any amendments to, or comments on, the petitioner's environmental assessment without further announcement in the **Federal Register** . If, based on its review, the agency finds that an environmental impact statement is not required and this petition results in a regulation, the notice of availability of the agency's finding of no significant impact and the evidence supporting that finding will be published with the regulation in the **Federal Register** in accordance with 21 CFR 25.51(b). Please note that on January 15, 2008, the FDA Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic submissions will be accepted by FDA through FDMS only. Dated: February 15, 2008. Laura M. Tarantino, Director, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition. [FR Doc. E8-3416 Filed 2-22-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0060] (formerly Docket No. 1998D-0021) Guidance for Industry: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of a document entitled “Guidance for Industry: Container and Closure System Integrity Testing *in Lieu* of Sterility Testing as a Component of the Stability Protocol for Sterile Products,” dated February 2008. The guidance document provides recommendations to sponsors for using methods other than sterility testing to confirm the integrity of container and closure systems as part of stability testing for sterile biological products, human and veterinary drugs, and medical devices. The guidance document does not apply to sterility testing methods for product sterility testing prior to release, as container and closure system integrity tests cannot demonstrate a product's initial sterility. The guidance announced in this notice finalizes the draft guidance entitled “Container and Closure Integrity Testing *in Lieu* of Sterility Testing as a Component of the Stability Protocol for Sterile Products,” dated January 1998. DATES: Submit written or electronic comments on agency guidances at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448; or to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research (CDER), 5600 Fishers Lane, Rockville, MD 20857; or to the Communications Staff (HFV-12), Center for Veterinary Medicine (CVM), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855; or to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220), Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. The guidance may also be obtained by calling CBER at 1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit written comments on the guidance 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.regulations.gov* . FOR FURTHER INFORMATION CONTACT: Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210,or David Hussong, Center for Drug Evaluation and Research (HFD-805), Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1228,or Geetha J. Jayan, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd, Rockville, MD 20850, 240-276-3747, or Mai Huynh, Center for Veterinary Medicine (HFV-140), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6963. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance document entitled “Guidance for Industry: Container and Closure System Integrity Testing *in Lieu* of Sterility Testing as a Component of the Stability Protocol for Sterile Products,” dated February 2008. The guidance document provides information to sponsors who propose using alternative methods to sterility testing to confirm container and closure integrity for sterile biological products, human and veterinary drugs, and medical devices throughout a product's dating period. The guidance document is applicable only to stability testing, a means of confirming expiration dating. The alternatives described in the guidance document are not offered as a replacement for sterility testing prior to product release, as container and closure system integrity tests cannot demonstrate a product's initial sterility. In the **Federal Register** of January 28, 1998 (63 FR 4272), FDA announced the availability of the draft guidance entitled “Container and Closure Integrity Testing *in Lieu* of Sterility Testing as a Component of the Stability Protocol for Sterile Products,” dated January 1998. FDA received numerous comments on the draft guidance and those comments were considered as the guidance was finalized. Editorial changes were made to improve clarity. This guidance document was prepared jointly by CBER, CDER, CVM, and CDRH. The guidance document is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance document represents the agency's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR 211.166 have been approved under OMB control number 0910-0139; the collections of information in 21 CFR 314.70 have been approved under OMB control number 0910-0001; the collections of information in 21 CFR 514.8 have been approved under OMB control number 0910-0032; the collections of information in 21 CFR 601.12 have been approved under OMB control number 0910-0338; the collections of information in 21 CFR 809.10 have been approved under OMB control number 0910-0485; the collections of information in 21 CFR 814.39 have been approved under OMB control number 0910-0231; and the collections of information in 21 CFR 820.75 have been approved under OMB control number 0910-0073. III. Comments Interested persons may, at any time, submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding the guidance. 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. A copy of the guidance and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that on January 15, 2008, the FDA Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic submissions will be accepted by FDA through FDMS only. IV. Electronic Access Persons with access to the Internet may obtain the document at *http://www.fda.gov/cber/guidelines.htm* , or *http://www.fda.gov/cder/guidance/index.htm* , or *http://www.fda.gov/cdrh/guidance.html* , or *http://www.fda.gov/cvm/guidance/published.htm* , or *http://www.fda.gov/ohrms/dockets/default.htm* . Dated: February 12, 2008. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E8-3487 Filed 2-22-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [FDA-2008-D-0108 (formerly Docket No. 2006D-0079)] Guidance for Industry: Guide to Minimize Food Safety Hazards for Fresh-cut Fruits and Vegetables; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of a final guidance document entitled “Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables” (the fresh-cut guidance or guidance). Previously, FDA announced the availability of the fresh-cut guidance as a “draft final” document, pending approval by the Office of Management and Budget

(OMB)of the information collection provisions in the guidance. FDA is publishing this notice to announce that the fresh-cut guidance is now final. The text of the guidance has not changed from the previously published draft final version. The fresh-cut guidance complements FDA's current good manufacturing practice

(CGMP)requirements for foods by providing specific guidance on the processing of fresh-cut produce. The fresh-cut guidance and the CGMP regulations are intended to assist processors in minimizing microbial food safety hazards common to the processing of most fresh-cut fruits and vegetables sold to consumers and retail establishments in a ready-to-eat form. DATES: Submit written or electronic comments on the guidance at any time. ADDRESSES: Submit written comments on the guidance 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.regulations.gov* . See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit written requests for single copies of the guidance to the Office of Food Safety (HFS-317), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1700 or FAX: 301-436-2651. Send one self-addressed adhesive label to assist the Center in processing your request. FOR FURTHER INFORMATION CONTACT: Rhoma Johnson, Center for Food Safety and Applied Nutrition (HFS-317), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2066 or FAX: 301-436-2651. SUPPLEMENTARY INFORMATION: I. Background Fresh-cut fruits and vegetables are minimally processed fruits and vegetables that have been altered in form by peeling, slicing, chopping, shredding, coring, or trimming, with or without washing or other treatment, prior to being packaged for use by the consumer or a retail establishment. The methods by which produce is grown, harvested, and processed may contribute to its contamination with pathogens and, consequently, the role of the produce in transmitting foodborne illness. Factors such as the high degree of handling and mixing of the product, the release of cellular fluids during cutting or chopping, the high moisture content of the product, the absence of a step lethal to pathogens, and the potential for temperature abuse in the processing, storage, transport, and retail display all enhance the potential for pathogens to survive and grow in fresh-cut produce. On March 6, 2006, FDA published in the **Federal Register** a notice entitled “Draft Guidance for Industry: Guide to Minimize Food Safety Hazards of Fresh-Cut Fruits and Vegetables” (71 FR 11209) (the March 2006 notice). FDA gave interested persons 60 days to comment on the draft guidance. The comment period closed on May 5, 2006. The draft guidance was revised based on public comments. The draft guidance contained information collection provisions subject to review by OMB under the Paperwork Reduction Act of 1995

(PRA)(44 U.S.C. 3501-3520). Under the PRA, Federal agencies must obtain approval from OMB for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3 and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the **Federal Register** concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, in the March 2006 notice (71 FR 11209), FDA gave interested persons 60 days to comment on the information collection provisions in the draft guidance. After providing the 60-day notice requesting public comment, section 3507 of the PRA (44 U.S.C. 3507) requires Federal agencies to submit the proposed collection to OMB for review and clearance. In compliance with 44 U.S.C. 3507, FDA submitted the proposed collection of information to OMB for review and clearance. On March 13, 2007, FDA published in the **Federal Register** a notice announcing the availability of a “Draft Final Guidance for Industry: Guide to Minimize Food Safety Hazards for Fresh-Cut Fruits and Vegetables” (72 FR 11364). This document was issued as a “draft final” guidance pending OMB approval of the collection of information. FDA announced OMB's approval of the collection of information in a notice published on October 19, 2007 (72 FR 59295). With OMB approval, FDA is publishing this notice announcing that the fresh-cut guidance is final and providing an OMB control number (See section II of this document). The fresh-cut guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The fresh-cut guidance is intended to assist processors in minimizing microbial food safety hazards common to the processing of most fresh-cut fruits and vegetables sold to consumers and retail establishments in a ready-to-eat form. This guidance represents FDA's current thinking on the microbiological hazards presented by most fresh-cut fruits and vegetables and the recommended control measures for such hazards in the processing of such produce. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You may use an alternative approach if such approach satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 This guidance contains information collection provisions that are subject to review by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collection of information in this guidance was approved under OMB control number 0910-0609. III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this guidance document at any time. 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. The guidance and 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 on January 15, 2008, the FDA Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic submissions will be accepted by FDA through FDMS only. IV. Electronic Access Persons with access to the Internet may obtain the guidance document at the following Web site: *http://www.cfsan.fda.gov/guidance.html* . Dated: February 15, 2008. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E8-3417 Filed 2-22-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the Board of Scientific Counselors, NIDDK. The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the National Institute of Diabetes and Digestive and Kidney Diseases, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. *Name of Committee:* Board of Scientific Counselors, NIDDK. *Date:* April 3, 2008. *Time:* 8 a.m. to 6:45 p.m. *Agenda:* To review and evaluate personal qualifications and performance, and competence of individual investigators. *Place:* National Institutes of Health, Building 10, 10 Center Drive, 9S235, Bethesda, MD 20892. *Contact Person:* Ira W. Levin, PhD, Chief, Section on Molecular Biophysics, Division of Intramural Research, National Institute of Diabetes and Digestive, and Kidney Diseases, NIH, Bethesda, MD 20892, 301-496-6844, *iwl@helix.nih.gov.* Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) Dated: February 15, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 08-815 Filed 2-22-08; 8:45 am]

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