Notices. Notice

11,410 words·~52 min read·/register/2007/10/25/07-5282·

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BILLING CODE 6712-01-P FEDERAL COMMUNICATIONS COMMISSION Notice of Public Information Collection(s) Being Reviewed by the Federal Communications Commission, Comments Requested October 16, 2007. SUMMARY: The Federal Communications Commission, as part of its continuing effort to reduce paperwork burdens, invites the general public and other Federal agencies to take this opportunity to

(PRA)of 1995 (PRA), Public Law No. 104-13. An agency may not conduct or sponsor a collection of information unless it displays a currently valid control number. Subject to the PRA, no person shall be subject to any penalty for failing to comply with a collection of information that does not display a valid control number. Comments are requested concerning

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

(b)the accuracy of the Commission's burden estimate;

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

(d)ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology. DATES: Written PRA comments should be submitted on or before December 24, 2007. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible. ADDRESSES: You may submit all PRA comments by e-mail or U.S. post mail. To submit your comments by e-mail, send them to *PRA@fcc.gov.* To submit your comments by U.S. mail, mark them to the attention of Cathy Williams, Federal Communications Commission, Room 1-C823, 445 12th Street, SW., Washington, DC 20554. FOR FURTHER INFORMATION CONTACT: For additional information about the information collection(s), contact Cathy Williams at

(202)418-2918 or send an e-mail to *PRA@fcc.gov.* SUPPLEMENTARY INFORMATION: *OMB Control Number:* 3060-0390. *Title:* Broadcast Station Annual Employment Report. *Form Number:* FCC Form 395-B. *Type of Review:* Extension of a currently approved collection. *Respondents:* Business or other for-profit entities; Not-for-profit institutions. *Number of Respondents:* 14,000. *Estimated Time per Response:* 0.88 hours. *Frequency of Response:* Annual reporting requirement. *Total Annual Burden:* 12,320 hours. *Nature of Response:* Required to obtain or retain benefits. *Confidentiality:* No need for confidentiality required. *Total Annual Costs:* None. *Privacy Impact Assessment:* No impact(s). *Needs and Uses:* FCC Form 395-B, “The Broadcast Station Annual Employment Report,” is used to assess industry employment trends and provide reports to Congress. Licensees with five or more full-time employees are required to file Form 395-B on or before September 30th of each year. The form is a data collection device used to compile statistics on the workforce employed by broadcast licensees/permittees. The report identifies each staff member by gender and race/ethnicity in each of the nine major job categories. On June 4, 2004, the FCC released the Third Report and Order and Fourth Notice of Proposed Rulemaking (3rd R&O), In the *Matter of Review of the Commission's Broadcast and Cable Equal Employment Opportunity Rules and Policies, MM Docket No. 98-204, FCC 04-103,* in which it considers issues relating to the Annual Employment Report forms, including Form 395-B, “The Broadcast Station Annual Employment Report.” In the 3rd R&O, the Commission is adopting revised rules requiring broadcasters and multichannel video programming distributors (MVPDs) to file annual employment reports. Radio and television broadcasters will use Form 395-B to file annual employment reports. The intent of this 3rd R&O is to reinstate and update requirements for broadcasters and MVPDs to file annual employment reports. The intent of the Fourth Notice of Proposed Rulemaking is to provide time for MVPDs, broadcast licensees, and the public to address the issue of whether the Commission should keep these forms confidential after they are filed. With the effective date of the rule revisions adopted in the 3rd R&O, MVPDs and broadcasters must start keeping records of their employees so they can prepare their annual employment reports due to be filed on or before September 30, 2004. Federal Communications Commission. Marlene H. Dortch, Secretary. [FR Doc. E7-21019 Filed 10-24-07; 8:45 am] BILLING CODE 6712-01-P FEDERAL COMMUNICATIONS COMMISSION Notice of Public Information Collection(s) Being Reviewed by the Federal Communications Commission for Extension Under Delegated Authority, Comments Requested. October 19, 2007. SUMMARY: The Federal Communications Commission, as part of its continuing effort to reduce paperwork burden invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s), as required by the Paperwork Reduction Act of 1995, Public Law 104-13. An agency may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act

(PRA)that does not display a valid control number. Comments are requested concerning

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

(b)the accuracy of the Commission's burden estimate;

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

(d)ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology. DATES: Persons wishing to comment on this information collection should submit comments December 24, 2007. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible. ADDRESSES: Direct all PRA comments to Nicholas A. Fraser, Office of Management and Budget (OMB),

(202)395-5887, or via fax at 202-395-5167, or via the Internet at *Nicholas_A._Fraser@omb.eop.gov* and to *Judith-B.Herman@fcc.gov,* Federal Communications Commission (FCC), Room 1-B441, 445 12th Street, SW., Washington, DC 20554. To submit your comments by e-mail send them to: *PRA@fcc.gov.* If you would like to obtain or view a copy of this information collection after the 60 day comment period, you may do so by visiting the OMB's ROCIS site at: *http://www.reginfo.gov/public/do/PRAMain.* FOR FURTHER INFORMATION CONTACT: For additional information about the information collection(s) send an e-mail to *PRA@fcc.gov* or contact Judith B. Herman at 202-418-0214. SUPPLEMENTARY INFORMATION: *OMB Control No.:* 3060-1059. *Title:* Global Mobile Personal Communications by Satellite (GMPCS)/E911 Call Centers. *Form No.:* N/A. *Type of Review:* Extension of a currently approved collection. *Respondents:* Business or other for-profit. *Number of Respondents:* 25 respondents; 25 responses. *Estimated Time Per Response:* 1 hour. *Frequency of Response:* Annual reporting requirement and recordkeeping requirement. *Obligation to Respond:* Required to obtain or retain benefits. *Total Annual Burden:* 25 hours. *Annual Cost Burden:* $5,000. *Privacy Act Impact Assessment:* N/A. *Nature and Extent of Confidentiality:* There is no need for confidentiality. *Needs and Uses:* This collection will be submitted as an extension (no change in reporting and recordkeeping requirements) after this 60 day comment period to Office of Management and Budget

(OMB)in order to obtain the full three year clearance from them. There is no change in the number of respondents/responses, the estimated burden hours and/or annual costs. The information collection requirements under this OMB control number (3060-1059) are used by the Commission under its authority to license commercial satellite services in the United States pursuant to 47 CFR Part 25. Additionally, the Commission has the authority to ensure that Mobile Satellite Service

(MSS)providers establish and maintain Emergency Call Center Service pursuant to 47 CFR 25.284. The recordkeeping and reporting requirements include data on MSS call center usage such as the aggregate number of calls that the call centers receive and the number of calls that required forwarding to a local Public Safety Answering Point (PSAP). The Commission uses this data to monitor compliance with the call center requirement and track usage trends. Such information is useful to the Commission in considering whether FCC rules require modification to accommodate the changing market. Without this collection of information that result from these rules, the Commission would not be able to monitor the MSS carriers' establishment of call centers which are essential to provide emergency services, such as handling emergency 911 telephone calls from American citizens. Federal Communications Commission. Marlene H. Dortch, Secretary. [FR Doc. E7-21021 Filed 10-24-07; 8:45 am] BILLING CODE 6712-01-P FEDERAL COMMUNICATIONS COMMISSION Notice of Public Information Collection(s) Being Reviewed by the Federal Communications Commission for Extension Under Delegated Authority, Comment Requested October 16, 2007. SUMMARY: The Federal Communications Commission, as part of its continuing effort to reduce paperwork burdens, invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s), as required by the Paperwork Reduction Act

(PRA)of 1995 (PRA), Public Law 104-13. An agency may not conduct or sponsor a collection of information unless it displays a currently valid control number. Subject to the PRA, no person shall be subject to any penalty for failing to comply with a collection of information that does not display a valid control number. Comments are requested concerning

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

(b)the accuracy of the Commission's burden estimate;

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

(202)418-2918 or send an e-mail to *PRA@fcc.gov.* SUPPLEMENTARY INFORMATION: *OMB Control Number:* 3060-0788. *Title:* DTV Showings/Interference Agreements. *Form Number:* Not applicable. *Type of Review:* Extension of a currently approved collection. *Respondents:* Businesses or other for-profit entities; not-for-profit institutions. *Number of Respondents:* 300. *Estimated Hours per Response:* 5 hours. *Frequency of Response:* On occasion reporting requirement. *Total Annual Burden:* 1,500 hours. *Total Annual Cost:* $2,400,000. *Nature of Response:* Required to obtain or retain benefits. *Confidentiality:* No need for confidentiality required. *Privacy Impact Assessment:* No impact(s). *Needs and Uses:* 47 CFR 73.623(c) requires applicants to submit a technical showing to establish that their proposed facilities will not result in additional interference to TV broadcast and DTV operations. The Commission permits broadcasters to agree to proposed DTV facilities that do not conform to the initial allotment parameters, even though they might be affected by potential new interference. The Commission will consider granting applications on the basis of interference agreements if it finds that such grants will serve the public interest. These agreements must be signed by all parties to the agreement. In addition, the Commission needs the following information to enable such public interest determinations: A list of parties predicted to receive additional interference from the proposed facility, a showing as to why a grant based on the agreements would serve the public interest, and technical studies depicting the additional interference. The technical showings and interference agreements will be used by FCC staff to determine if the public interest would be served by the grant of the application and to ensure that the proposed facilities will not result in additional interference. Federal Communications Commission. Marlene H. Dortch, Secretary. [FR Doc. E7-21024 Filed 10-24-07; 8:45 am] BILLING CODE 6712-01-P FEDERAL COMMUNICATIONS COMMISSION Notice of Public Information Collection(s) Being Submitted to the Office of Management and Budget, Comment Requested October 18, 2007. SUMMARY: The Federal Communications Commission, as part of its continuing effort to reduce paperwork burden invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s), as required by the Paperwork Reduction Act

(PRA)of 1995, Public Law 104-13. An agency may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act

(PRA)that does not display a valid control number. Comments are requested concerning

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

(b)the accuracy of the Commission's burden estimate;

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

(PRA)comments should be submitted on or before December 24, 2007. If you anticipate that you will be submitting PRA comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the FCC contact listed below as soon as possible. ADDRESSES: Direct all PRA comments to Nicholas A. Fraser, Office of Management and Budget,

(202)395-5887, or via fax at 202-395-5167 or via internet at *Nicholas_A._Fraser@omb.eop.gov* and to *Judith-B.Herman@fcc.gov,* Federal Communications Commission, Room 1-B441, 445 12th Street, SW., DC 20554 or an e-mail to *PRA@fcc.gov.* If you would like to obtain or view a copy of this information collection after the 60 day comment period, you may do so by visiting the OMB's ROCIS site at: *http://www.reginfo.gov/public/do/PRAMain.* FOR FURTHER INFORMATION CONTACT: For additional information or copies of the information collection(s), contact Judith B. Herman at 202-418-0214 or via the Internet at *Judith-B.Herman@fcc.gov.* SUPPLEMENTARY INFORMATION: *OMB Control Number:* 3060-0057. *Title:* Application for Equipment Authorization. *Form No.:* FCC Form 731. *Type of Review:* Revision of a currently approved collection. *Respondents:* Business or other for-profit. *Number of Respondents:* 600 respondents; 600 responses. *Estimated Time Per Response:* 25 hours. *Frequency of Response:* On occasion reporting requirement and third party disclosure requirement. *Obligation to Respond:* Required to obtain or retain benefits. *Total Annual Burden:* 250,000 hours. *Total Annual Cost:* $11,107,500. *Privacy Act Impact Assessment:* N/A. *Nature and Extent of Confidentiality:* There is no need for confidentiality. *Needs and Uses:* The Commission will submit this revision to the OMB after this 60 day comment period to obtain the full three-year clearance from them. On April 23, 2007, the Commission released a *Second Report and Order,* FCC 07-56, ET Docket No. 03-201. The Commission amended the rules to provide for more efficient equipment authorization of both existing modular transmitter devices and emerging partitioned (or “split”) modular transmitter devices in Section 15.212. Single modular transmitters consist of a completely self-contained radio frequency transmitter device that is typically incorporated into another product, host or device. Split modular transmitters consist of two components: a radio front-end with antenna (or radio devices) and a transmitter control element (or specific hardware on which the software that controls the radio operation resides). All single or split modular transmitters are approved with an antenna. The modular transmitter must be labeled with its own FCC ID number, and if the FCC ID number is not visible when the module is installed inside another device, then the outside of the device into which the module is installed must also display a label referring to the enclosed module. This exterior label can use wording such as the following: “Contains Transmitter Module FCC ID: XYZMODEL1” or “Contains FCC ID: XYZMODEL1.” Any similar wording that expresses the same meaning may be used. The grantee may either provide such a label, an example of which must be included in the application for equipment authorization (FCC Form 731), or must provide adequate instructions along with the module which explain this requirement. In the latter case, a copy of these instructions must be included in the application for equipment authorization. The modular transmitter must comply with any specific rule or operating requirements applicable to the transmitter and the manufacturer must provide adequate instructions along with the module to explain any such requirements. A copy of these instructions must also be included in the FCC Form 731. FCC Form 731 will be modified to accommodate identification and validation of the specific devices approved by this rulemaking. The rule change will benefit manufacturers by allowing greater flexibility in certifying equipment and providing relief from the need to obtain a new equipment authorization each time the same transmitter is installed in a different final product. The rule change in the *Second Report and Order* will also enable manufacturers to develop more flexible and more advanced unlicensed transmitter technologies. In addition to the rule changes noted above, this requirement is being modified to reflect the growth in the use of the Radio Frequency

(RF)spectrum for devices subject to equipment authorization. An adjustment is going to be reported to the OMB due to a reduction in the number of respondents filing the FCC Form 731 with the Commission. The number of responses is filed with both the FCC and the Telecommunications Certification Bodies

(TCBs)and the total annual cost is reflected in this submission to the OMB. Federal Communications Commission. Marlene H. Dortch, Secretary. [FR Doc. E7-21030 Filed 10-24-07; 8:45 am] BILLING CODE 6712-01-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 November 9, 2007. **A. Federal Reserve Bank of Kansas City** (Todd Offenbacker, Assistant Vice President) 925 Grand Avenue, Kansas City, Missouri 64198-0001: *1. The Burns Group consisting of R. Dean Phillips, individually and as a member of the Burns Group; Janice Sauvage, as trustee of the Janice Sauvage Trust No. 2; the Janice Sauvage Trust No. 2, individually and as a member of the Burns Group; and Philip M. Burns, all of Las Vegas, Nevada* ; to acquire voting shares of First Financial Services, Inc., and thereby indirectly acquire voting shares of First National Bank and Trust Company, both of Falls City, Nebraska. Board of Governors of the Federal Reserve System, October 22, 2007. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E7-20992 Filed 10-24-07; 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 website at *www.ffiec.gov/nic/* . Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than November 19, 2007. **A. Federal Reserve Bank of Atlanta** (David Tatum, Vice President) 1000 Peachtree Street, N.E., Atlanta, Georgia 30309: *1. Touchstone Bancshares, Inc.* , Norcross, Georgia; to become a bank holding company by acquiring 100 percent of the voting shares of Touchstone National Bank, Duluth, Georgia (in organization). **B. Federal Reserve Bank of Kansas City** (Todd Offenbacker, Assistant Vice President) 925 Grand Avenue, Kansas City, Missouri 64198-0001: *1. First National of Nebraska, Inc., and Lauritzen Corporation* , both of Omaha, Nebraska; to acquire 100 percent of the voting shares of Mills County Bancorp, and thereby indirectly acquire voting shares of Mills County Bank, National Association, both in Glenwood, Iowa. Board of Governors of the Federal Reserve System, October 22, 2007. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E7-20993 Filed 10-24-07; 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 website at *www.ffiec.gov/nic/* . Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than November 16, 2007. **A. Federal Reserve Bank of New York** (Anne MacEwen, Bank Applications Officer) 33 Liberty Street, New York, New York 10045-0001: *1. Greater Rochester Bancorp, Inc.,* to become a bank holding company by acquiring 100 percent of the voting shares of Genesee Regional Bank, both of Rochester, New York. **B. Federal Reserve Bank of Chicago** (Burl Thornton, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414: *1. NEB Corporation, Fond du Lac, Wisconsin;* to acquire 10.07 percent of the voting shares of First Menasha Bancshares, Inc., Neenah, Wisconsin, and thereby indirectly acquire First National Bank-Fox Valley, Neenah, Wisconsin. **C. Federal Reserve Bank of Minneapolis** (Jacqueline G. King, Community Affairs Officer) 90 Hennepin Avenue, Minneapolis, Minnesota 55480-0291: *1. Highland Bancshares, St. Michael, Minnesota;* to acquire 100 percent of the voting shares of Ridgedale State Bank, Minnetonka, Minnesota. Board of Governors of the Federal Reserve System, October 19, 2007. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E7-20995 Filed 10-24-07; 8:45 am] BILLING CODE 6210-01-S FEDERAL TRADE COMMISSION Agency Information Collection Activities; Submission for OMB Review; Comment Request AGENCY: Federal Trade Commission. ACTION: Notice. SUMMARY: The information collection requirements described below will be submitted to the Office of Management and Budget (“OMB”) for review, as required by the Paperwork Reduction Act. The Federal Trade Commission (“FTC”) is seeking public comments on its proposal to extend through November 30, 2010 the current OMB clearance for information collection requirements contained in its Prescreen Opt-Out Disclosure Rule. That clearance expires on November 30, 2007. DATES: Comments must be filed by November 26, 2007. ADDRESSES: Interested parties are invited to submit written comments. Comments should refer to “Prescreen Opt-Out Disclosure Rule: FTC File No. P075417” 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, with two complete copies, to the following address: Federal Trade Commission, Room H 135 (Annex J), 600 Pennsylvania Ave., NW., Washington, DC 20580. Because paper mail in the Washington area and at the Commission is subject to delay, please consider submitting your comments in electronic form, as prescribed below. However, if the comment contains any material for which confidential treatment is requested, it must be filed in paper form, and the first page of the document must be clearly labeled “Confidential.” 1 The FTC is requesting that any comment filed in paper form be sent by courier or overnight service, if possible. 1 Commission Rule 4.2(d), 16 CFR 4.2(d). 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). Comments filed in electronic form should be submitted by using the following weblink: *https://secure.commentworks.com/ftc-PrescreenOpt-Out* (and following the instructions on the Web-based form). To ensure that the Commission considers an electronic comment, you must file it on the Web-based form at the weblink: *https://secure.commentworks.com/ftc-PrescreenOpt-Out* . If this notice appears at *http://www.regulations.gov* , you may also file an electronic comment through that Web site. The Commission will consider all comments that *http://www.regulations.gov* forwards to it. All comments should additionally be submitted to: Office of Management and Budget, Attention: Desk Officer for the Federal Trade Commission. Comments should be submitted via facsimile to

(202)395-6974 because U.S. Postal Mail is subject to lengthy delays due to heightened security precautions. 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 will be considered by the Commission and will be available to the public on the FTC website, to the extent practicable, at *http://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* . FOR FURTHER INFORMATION CONTACT: Requests for additional information should be addressed to Katherine Armstrong, Attorney, Division of Privacy and Identity Protection, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue, NW., Washington, DC 20580,

(202)326-3250. SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act (“PRA”), 44 U.S.C. 3501-3520, federal agencies must obtain approval from OMB for each collection of information they conduct or sponsor. On August 1, 2007, the FTC sought comment on the information collection requirements associated with the FTC’s Prescreen Opt-Out Disclosure Rule (“Prescreen Rule” or “Rule), 16 CFR Part 642. 2 No comments were received. Pursuant to the OMB regulations that implement the PRA (5 CFR Part 1320), the FTC is providing this second opportunity for public comment while seeking OMB approval to extend the existing paperwork clearance for the Prescreen Rule. All comments should be filed as prescribed in the **ADDRESSES** section above, and must be received on or before November 26, 2007. 2 72 FR 42091 (Aug. 1, 2007). Section 615(d) of the Fair Credit Reporting Act (“FCRA”), 15 U.S.C. 1681m(d)(1), requires any person who uses a consumer report in order to make an unsolicited firm offer of credit or insurance to a consumer to provide with each written solicitation a clear and conspicuous statement that:

(A)information contained in the consumer’s consumer report was used in connection with the transaction;

(B)the consumer received the offer of credit or insurance because the consumer satisfied the criteria for credit worthiness or insurability under which the consumer was selected for the offer;

(C)if applicable, the credit or insurance may not be extended if, after the consumer responds to the offer, the consumer does not meet the criteria used to select the consumer for the offer or any applicable criteria bearing on credit worthiness or insurability or does not furnish any required collateral;

(D)the consumer has a right to prohibit information contained in the consumer’s file with any consumer reporting agency from being used in connection with any credit or insurance transaction that is not initiated by the consumer; and

(E)the consumer may exercise the right referred to in subparagraph

(D)by notifying a notification system established under section 604(e) [of the FCRA]. Section 615(d)(1) of the FCRA, 15 U.S.C. 1681m(d)(1). The Fair and Accurate Credit Transactions Act of 2003, Pub. L. 108-159, 117 Stat. 1952 (“FACT Act”) was signed into law on December 4, 2003. Section 213(a) of the FACT Act amended FCRA Section 615(d) to require that the statement mandated by Section 615(d) “be presented in such format and in such type size and manner as to be simple and easy to understand, as established by the Commission, by rule, in consultation with the Federal banking agencies and the National Credit Union Administration.” The Commission published the Final Rule implementing this provision in the **Federal Register** on January 31, 2005, and the Rule became effective on August 1, 2005. The Rule adopted a “layered” notice approach that requires a short, simple, and easy-to-understand statement of consumers’ opt-out rights on the first page of the prescreened solicitation, along with a longer statement containing additional details elsewhere in the solicitation. Specifically, the Rule requires that a short notice be placed on the front side of the first page of the principal promotional document in the solicitation, or, if provided electronically, on the same page and in close proximity to the principal marketing message. The Rule specifies that the type size be larger than the type size of the principal text on the same page, but in no event smaller than 12-point type. If the notice is provided by electronic means, the entity providing it must take reasonable steps to ensure that the type size is larger than the type size of the principal text on the same page. The Rule further provides that the long notice that appears elsewhere in the solicitation be in a type size that is no smaller than the type size of the principal text on the same page, but in no event smaller than 8-point type. The long notice must begin with the heading “PRESCREEN & OPT-OUT NOTICE,” which must be in capital letters and underlined, set apart from other text on the page, and in a type style that is distinct from the principal type style used on the same page. The Rule also includes model notices in English and Spanish. Burden statement: **Estimated total annual hours burden:** 1,000 to 1,500 hours (rounded to the nearest thousand). Based on public comments received in response to the Commission’s 2004 Notice of Proposed Rulemaking, 3 when issuing the final Rule, the Commission estimated that the annual burden to industry would be between 43,600 and 45,600 hours. 4 This estimate was comprised of 500 to 750 companies each spending 8 hours to revise an existing solicitation, plus 100 companies each needing an additional 396 hours to revise multiple solicitations ((500 companies x 8 burden hours + 39,600 burden hours = 43,600 burden hours); (750 companies x 8 burden hours + 39,600 burden hours = 45,600 burden hours)). 5 The Commission further estimated that the total annual cost to industry would be between $1,157,894 and $1,213,329. 6 3 69 FR 58861 (Oct. 1, 2004). 4 70 FR 5022 (Jan. 31, 2005). 5 The Commission estimated that each of the 100 companies would revise 99 additional solicitations and incur 4 hours of burden per solicitation (100 companies x 99 solicitations x 4 hours of burden = 39,600 burden hours). 6 This estimate was based on Bureau of Labor Statistics data (as of July, 2002), as follows: 2 hours of managerial/professional time at $31.55 per hour; plus 6 hours of skilled technical labor at $26.44 per hour; multiplied by 500 and 750 companies, for a total of $110,870 and $166,305, respectively. These sums were added to $1,047,024 (39,600 hours of skilled technical labor at $26.44 per hour) for revising multiple solicitations. The requirements of the Rule have not changed since OMB’s 2004 approval of the final Rule. The previous estimates included a one-time burden to reprogram and update systems to revise existing notices and to re-format solicitations to comply with the Rule. Because the Rule has been in effect since August 1, 2005, covered entities have already incurred the one-time costs of transitioning to compliant notice formats. Accordingly, the annual PRA-related burden associated with the Rule is now reduced. FTC staff believes that the primary cost of continuing to comply with the Rule is limited to any legal review each entity determines is necessary to remain in compliance. FTC staff continues to estimate that between 500 and 750 entities make prescreened solicitations. Because no additional revision or reformatting is necessary, however, staff has lowered the estimate of the burden hours to approximately 2 hours (one quarter of one business day), rather than the estimated 8 hours that was the estimate to revise and reformat solicitations when the Rule was promulgated. Accordingly, the total annual burden is between 1,000 and 1,500 hours (500 to 750 entities x 2 hours of annual burden). FTC staff assumes that in-house legal counsel will handle most of the compliance review and has applied an average hourly wage of $250/hour for their labor. Accordingly, the total cost for all affected entities would be between $250,000 and $375,000 (1000 to 1,500 burden hours x $250 per hour of legal review time). John D. Graubert, Acting General Counsel. [FR Doc. E7-21067 Filed 10-24-07: 8:45 am] BILLING CODE 6750-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Toxic Substances and Disease Registry [ATSDR-235] Proposed Substances To Be Evaluated for Set 22 Toxicological Profiles AGENCY: Agency for Toxic Substances and Disease Registry (ATSDR), Department of Health and Human Services (HHS). ACTION: Request for comments on the proposed substances to be evaluated for Set 22 toxicological profiles. SUMMARY: This notice announces the list of proposed substances that will be evaluated for CERCLA Set 22 toxicological profile development. ATSDR's Division of Toxicology and Environmental Medicine is soliciting public nominations from the list of proposed substances to be evaluated for toxicological profile development. ATSDR also will consider the evaluation of any additional substances that may have public health implications. DATES: Nominations must be submitted within 30 days of the publication of this notice. The 30-day period begins October 26th, 2007 and ends November 26th, 2007. ADDRESSES: Nominations may be submitted electronically, by mail, or by facsimile. Refer to the section *Submission of Nominations* (below) for specific addresses and/or the facsimile number. FOR FURTHER INFORMATION CONTACT: Contact Commander Jessilynn B. Taylor, Division of Toxicology and Environmental Medicine, Agency for Toxic Substances and Disease Registry, Mailstop F-32, 1600 Clifton Road, NE., Atlanta, Georgia 30333, telephone

(770)488-3313. SUPPLEMENTARY INFORMATION: The Superfund Amendments and Reauthorization Act of 1986

(SARA)[42 U.S.C. 9601 *et seq.* ] amended the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA or Superfund) [42 U.S.C. 9601 *et seq.* ] by establishing certain requirements for ATSDR and the U.S. Environmental Protection Agency

(EPA)with regard to hazardous substances that are most commonly found at facilities on the CERCLA National Priorities List (NPL). Among these statutory requirements is a mandate for the Administrator of ATSDR to prepare toxicological profiles for each substance included on the Priority List of Hazardous Substances. This list has identified 275 hazardous substances that ATSDR and EPA determined pose the most significant potential threat to human health. The availability of the revised list of the 275 priority substances was announced in the **Federal Register** on December 7, 2005 (70 FR 702840). For prior versions of the list of substances, see **Federal Register** notices dated April 17, 1987 (52 FR 12866); October 20, 1988 (53 FR 41280); October 26, 1989 (54 FR 43619); October 17, 1990 (55 FR 42067); October 17, 1991 (56 FR 52166); October 28, 1992 (57 FR 48801); February 28, 1994 (59 FR 9486); April 29, 1996 (61 FR 18744; November 17, 1997 (62 FR 61332); October 21, 1999 (64 FR 56792); October 25, 2001 (66 FR 54014) and November 7, 2003 (68 FR 63098). Proposed Substances To Be Evaluated for Set 22 Toxicological Profiles Each year, ATSDR develops a list of priority substances that will be evaluated for toxicological profile development. This list was compiled, on the basis of ATSDR's Priority List of Hazardous Substances, with consideration of the amount of relevance of newly published scientific literature. The following 73 substances will be evaluated: Substance name CAS No. 1 PERFLUOROOCTANOIC ACID

(1)PERFLUOROCYL SULFONATES

(1)2 MERCURY 007439-97-6 METHYLMERCURY 022967-92-6 MERCURIC CHLORIDE 007487-94-7 3 POLYCHLORINATED BIPHENYLS 001336-36-3 AROCLOR 1254 011097-69-1 AROCLOR 1260 011096-82-5 AROCLOR 1248 012672-29-6 AROCLOR 1242 053469-21-9 AROCLOR 012767-79-2 AROCLOR 1221 011104-28-2 AROCLOR 1016 012674-11-2 AROCLOR 1232 011141-16-5 AROCLOR 1240 071328-89-7 TETRACHLOROBIPHENYL 026914-33-0 4 CADMIUM 007440-43-9 5 POLYCYCLIC AROMATIC HYDROCARBONS 130498-29-2 BENZO(A)PYRENE 000050-32-8 BENZO(B)FLUORANTHENE 000205-99-2 DIBENZO(A,H)ANTHRACENE 000053-70-3 BENZO(A)ANTHRACENE 000056-55-3 BENZO(K)FLUORANTHENE 000207-08-9 BENZOFLUORANTHENE 056832-73-6 FLUORANTHENE 000206-44-0 CHRYSENE 000218-01-9 ACENAPHTHENE 000083-32-9 INDENO(1,2,3-CD)PYRENE 000193-39-5 BENZOPYRENE 073467-76-2 PHENANTHRENE 000085-01-8 PYRENE 000129-00-0 FLUORENE 000086-73-7 ANTHRACENE 000120-12-7 BENZO(A)FLUORANTHENE 000203-33-8 BENZO(GHI)PERYLENE 000191-24-2 ACENAPHTHYLENE 000208-96-8 BENZO(J)FLUORANTHENE 000205-82-3 BENZO(E)PYRENE 000192-97-2 BENZOPERYLENE 011057-45-7 BENZO(B)ANTHRACENE 000092-24-0 DIBENZ(A,J)ANTHRACENE 000224-41-9 BENZO(GHI)FLUORANTHENE 000203-12-3 1-METHYLPYRENE 002381-21-7 6 CHLOROFORM 000067-66-3 7 DDT, P,P′- 000050-29-3 DDE, P,P′- 000072-55-9 DDD, P,P′- 000072-54-8 DDT, O,P′- 000789-02-6 DDD, O,P′- 000053-19-0 DDE, O,P′- 003424-82-6 8 TRICHLOROETHYLENE 000079-01-6 9 IELDRIN 000060-57-1 ALDRIN 000309-00-2 10 CHROMIUM, HEXAVALENT 018540-29-9 CHROMIUM(VI) OXIDE 001333-82-0 CHROMIUM 007440-47-3 CHROMIUM TRIOXIDE 007738-94-5 CHROMIUM, TRIVALENT 016065-83-1 11 CHLORDANE 000057-74-9 CIS-CHLORDANE 005103-71-9 TRANS-CHLORDANE 005103-74-2 OXYCHLORDANE 027304-13-8 GAMMA-CHLORDENE 056641-38-4 CHLORDANE, TECHNICAL 012789-03-6 ALPHA-CHLORDENE 056534-02-2 NONACHLOR, TRANS- 039765-80-5 NONACHLOR, CIS- 005103-73-1 CHLORDENE 003734-48-3 12 HEXACHLOROBUTADIENE 000087-68-3 13 COAL TAR CREOSOTE 008001-58-9 COAL TARS 008007-45-2 COAL TAR PITCH 065996-93-2 14 BENZIDINE 000092-87-5 15 TOXAPHENE 008001-35-2 16 TETRACHLOROETHYLENE 000127-18-4 17 1,2-DIBROMOETHANE 000106-93-4 18 DISULFOTON 000298-04-4 19 3,3′-DICHLOROBENZIDINE 000091-94-1 20 BERYLLIUM 007440-41-7 21 ENDRIN 000072-20-8 ENDRIN KETONE 053494-70-5 ENDRIN ALDEHYDE 007421-93-4 22 1,2-DIBROMO-3-CHLOROPROPANE 000096-12-8 DIBROMOCHLOROPROPANE 067708-83-2 23 PENTACHLOROPHENOL 000087-86-5 24 DI-N-BUTYL PHTHALATE 000084-74-2 25 ENDOSULFAN SULFATE 001031-07-8 ENDOSULFAN 000115-29-7 ENDOSULFAN, ALPHA 000959-98-8 ENDOSULFAN, BETA 033213-65-9 26 METHOXYCHLOR 000072-43-5 27 METHANE 000074-82-8 28 TOLUENE 000108-88-3 29 2-HEXANONE 000591-78-6 30 2,3,7,8-TETRACHLORODIBENZO-P-DIOXIN 001746-01-6 HEXACHLORODIBENZO-P-DIOXIN 034465-46-8 HEPTACHLORODIBENZO-P-DIOXIN 037871-00-4 TETRACHLORODIBENZO-P-DIOXIN 041903-57-5 PENTACHLORODIBENZO-P-DIOXIN 036088-22-9 1,2,3,4,6,7,8-HEPTACHLORODIBENZO-P-DIOXIN 035822-46-9 OCTACHLORODIBENZO-P-DIOXIN 003268-87-9 1,2,3,6,7,8-HEXACHLORODIBENZO-P-DIOXIN 057653-85-7 1,2,3,4,7,8-HEXACHLORODIBENZO-P-DIOXIN 039227-28-6 1,2,3,7,8,9-HEXACHLORODIBENZO-P-DIOXIN 019408-74-3 1,2,3,7,8-PENTACHLORODIBENZO-P-DIOXIN 040321-76-4 31 DI(2-ETHYLHEXYL)PHTHALATE 000117-81-7 32 1,1-DICHLOROETHENE 000075-35-4 33 METHYLENE CHLORIDE 000075-09-2 34 2,4,6-TRINITROTOLUENE 000118-96-7 35 BROMODICHLOROETHANE 000683-53-4 36 1,2-DICHLOROETHANE 000107-06-2 37 2,4,6-TRICHLOROPHENOL 000088-06-2 TETRACHLOROPHENOL 025167-83-3 2,4-DICHLOROPHENOL 000120-83-2 2,4,5-TRICHLOROPHENOL 000095-95-4 2-CHLOROPHENOL 000095-57-8 2,3,4,5-TETRACHLOROPHENOL 004901-51-3 2,3,5,6-TETRACHLOROPHENOL 000935-95-5 2,3,4,6-TETRACHLOROPHENOL 000058-90-2 4-CHLOROPHENOL 000106-48-9 CHLOROPHENOL 025167-80-0 38 2,4-DINITROPHENOL 000051-28-5 39 BIS(2-CHLOROETHYL) ETHER 000111-44-4 40 ASBESTOS 001332-21-4 CHRYSOTILE ASBESTOS 012001-29-5 AMOSITE ASBESTOS 012172-73-5 41 HEXACHLOROBENZENE 000118-74-1 42 RADIUM-226 013982-63-3 RADIUM 007440-14-4 RADIUM-228 015262-20-1 RADIUM-224 013233-32-4 43 2,4-DINITROTOLUENE 000121-14-2 DINITROTOLUENE 025321-14-6 2,6-DINITROTOLUENE 000606-20-2 44 ETHION 000563-12-2 45 THORIUM 007440-29-1 THORIUM-230 014269-63-7 THORIUM-228 014274-82-9 46 4,6-DINITRO-O-CRESOL 000534-52-1 47 RADON 010043-92-2 RADON-222 014859-67-7 RADON-220 022481-48-7 48 CHLOROBENZENE 000108-90-7 49 N-NITROSODI-N-PROPYLAMINE 000621-64-7 50 MANGANESE 007439-96-5 MANGANESE DIOXIDE 001313-13-9 51 POLONIUM-210 013981-52-7 52 LEAD-210 014255-04-0 53 CHLORPYRIFOS 002921-88-2 54 NEPTUNIUM-237 013994-20-2 55 CHLORDECONE 000143-50-0 MIREX 002385-85-5 56 S,S,S-TRIBUTYL PHOSPHOROTRITHIOATE 000078-48-8 57 BROMINE 007726-95-6 58 1,2,3-TRICHLOROBENZENE 000087-61-6 59 DICOFOL 000115-32-2 60 PARATHION 000056-38-2 61 TRICHLOROFLUOROETHANE 027154-33-2 62 TRIFLURALIN 001582-09-8 63 4,4′-METHYLENEBIS(2-CHLOROANILINE) 000101-14-4 64 PENTACHLOROBENZENE 000608-93-5 65 1,1-DICHLOROETHANE 000075-34-3 66 1,1,2-TRICHLOROETHANE 000079-00-5 67 1,2,3,4,6,7,8,9-OCTACHLORODIBENZOFURAN 039001-02-0 HEPTACHLORODIBENZOFURAN 038998-75-3 2,3,4,7,8-PENTACHLORODIBENZOFURAN 057117-31-4 HEXACHLORODIBENZOFURAN 055684-94-1 PENTACHLORODIBENZOFURAN 030402-15-4 2,3,7,8-TETRACHLORODIBENZOFURAN 051207-31-9 DIBENZOFURANS, CHLORINATED 042934-53-2 1,2,3,4,6,7,8-HEPTACHLORODIBENZOFURAN 067562-39-4 1,2,3,7,8,9-HEXACHLORODIBENZOFURAN 072918-21-9 TETRACHLORODIBENZOFURAN 030402-14-3 1,2,3,6,7,8-HEXACHLORODIBENZOFURAN 057117-44-9 1,2,3,4,7,8-HEXACHLORODIBENZOFURAN 070648-26-9 2,3,4,6,7,8-HEXACHLORODIBENZOFURAN 060851-34-5 1,2,3,7,8-PENTACHLORODIBENZOFURAN 057117-41-6 1,2,3,4,7,8,9-HEPTACHLORODIBENZOFURAN 055673-89-7 68 TRICHLOROETHANE 025323-89-1 69 HEXACHLOROCYCLOPENTADIENE 000077-47-4 70 1,2-DIPHENYLHYDRAZINE 000122-66-7 71 NANOMATERIALS 72 VANADIUM 007440-62-2 73 FORMALDEHYDE 000050-00-0

(1)Various. Submission of Nominations for the Evaluation Set 22 *Proposed Substances:* Today's notice also invites voluntary public nominations for substances not listed in this notice. Nominations are most useful if they include the nominator, including full name, title, affiliation, email address, and telephone number. ATSDR will evaluate all data and information associated with nominated substances and will determine the final list of substances that will be chosen for toxicological profile development. Substances will be chosen according to ATSDR's specific guidelines for selection, found in the *Selection Criteria* announced in the **Federal Register** on May 7th, 1993 (87 FR 27288). Please submit nominations by one of the following methods: • *E-mail: jxt1@cdc.gov* . • *Fax:* 770.488.4178. • *Mail:* CDR Jessilynn Taylor, 1600 Clifton Rd, NE., MS F32, Atlanta, GA, 30333. Please ensure that your comments are submitted within the specified nomination period. Nominations received after the closing date will be marked as late and may be considered only if time permits. Dated: October 19, 2007. Ken Rose, Director, Office of Policy, Planning and Evaluation, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry. [FR Doc. E7-21018 Filed 10-24-07; 8:45 am] BILLING CODE 4163-70-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 1999N-2337 (formerly Docket No. 99N-2337)] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; CGMP for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV Infection (“Lookback”) AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a collection of information entitled “CGMP for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV Infection (“Lookback”)” has been approved by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: In the **Federal Register** of August 24, 2007 (72 FR 48766), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0610. The approval expires on October 31, 2010. A copy of the supporting statement for this information collection is available on the Internet at *http://www.fda.gov/ohrms/dockets* . Dated: October 19, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-21055 Filed 10-24-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0278] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Continuous Marketing Applications: Pilot—Scientific Feedback and Interactions During Development of Fast Track Products Under the Prescription Drug User Fee Act AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a collection of information entitled “ Guidance for Industry on Continuous Marketing Applications: Pilot—Scientific Feedback and Interactions During Development of Fast Track Products Under the Prescription Drug User Fee Act“ has been approved by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4816. SUPPLEMENTARY INFORMATION: In the **Federal Register** of May 21, 2007 (72 FR 28495), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0518. The approval expires on September 30, 2010. A copy of the supporting statement for this information collection is available on the Internet at *http://www.fda.gov/ohrms/dockets* . Dated: October 19, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-21056 Filed 10-24-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0390] User Fee Program for Advisory Review of Direct-to-Consumer Television Advertisements for Prescription Drug and Biological Products; Request for Notification of Participation and Number of Advertisements for Review AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for notification of participation. SUMMARY: The Food and Drug Administration

(FDA)is issuing this notice to explain the new direct-to-consumer

(DTC)user fee program (DTC user fee program) established by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and, as required by the new law, to ask companies to notify FDA within 30 calendar days if they intend to participate in the DTC user fee program during fiscal year

(FY)2008 and, if they do plan to participate, to identify the number of DTC television advertisements for prescription drug and biological products they plan to submit for advisory review during FY 2008. The information gathered in response to this notice will be used to establish the FY 2008 fee that will be charged for each FY 2008 advisory review submission to FDA and to fund the operating reserve established under FDAAA. DATES: Submit written responses by November 26, 2007. ADDRESSES: Submit written responses by overnight courier service to Wayne Amchin, Project Manager, Division of Drug Marketing, Advertising, and Communications (DDMAC), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 1477, Silver Spring, MD 20993-0002. For companies that use Federal Express or DHL for overnight courier service, the courier will be able to deliver packages directly to DDMAC's office. Other courier services will need to call 301-796-1200 to request that the DDMAC project manager meet the courier at the security desk for package pickup. In addition, fax a copy of your response to 301-796-9878 or e-mail a copy to *dtcp@fda.hhs.gov* . FOR FURTHER INFORMATION CONTACT: For questions about the DTC user fee program, contact Wayne Amchin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 1477, Silver Spring, MD 20993-0002, 301-796-1200, FAX: 301-796-9878, e-mail: *dtcp@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: I. Introduction On September 27, 2007, the President signed into law FDAAA (Public Law 110-85). Title I of this statute reauthorized the Prescription Drug User Fee Act (PDUFA) for FYs 2008 to 2012. In addition, Title I also created new section 736A of the Federal Food, Drug, and Cosmetic Act (the act), which authorizes a new and separate user fee program for the advisory review of DTC prescription drug television advertisements. Participation in the program is voluntary. Sponsors can decide, at their own discretion, whether to seek FDA advisory review of DTC prescription drug television advertisements in advance of publicly broadcasting them. However, under the new law, if a sponsor decides to seek FDA advisory review of a DTC television advertisement, the sponsor must pay a required fee for that review. FDA has agreed to use the resources collected under this program to meet certain performance goals set forth in an enclosure to letters dated September 27, 2007, from the Secretary of Health and Human Services (the Secretary) to the Chairmen and Ranking Minority Members of the Senate Committee on Health, Education, Labor, and Pensions and the House of Representatives Committee on Energy and Commerce. The letters are posted at *http://www.fda.gov/cder/pdufa* . FDA is issuing this **Federal Register** notice to explain the new program and to ask companies to notify FDA by November 26, 2007:

(1)If they intend to participate in the FY 2008 DTC user fee program and

(2)if they do plan to participate, to identify the number of DTC television advertisements they plan to submit for advisory review during FY 2008 to DDMAC in the Center for Drug Evaluation and Research or the Advertising and Promotional Labeling Branch in the Center for Biologics Evaluation and Research. The information gathered in response to this notice will be used to establish the fees that will be charged for each advisory review submission to FDA during FY 2008 and to create an operating reserve. II. Background FDA's prescription drug advertising regulations give companies the option of submitting proposed television advertisements to FDA for advisory review before publicly disseminating them. In this way, companies can benefit from FDA's advice on whether or not the advertisements are accurate, balanced, and adequately supported. The submission of advertisements for advisory review gives sponsors the opportunity to address any problems before the advertisements are shown to the public and can improve the quality of the advertisements. Companies have recognized the benefits of this advisory review mechanism, and between 2000 and 2006, FDA received an average of approximately 150 television advertisements for advisory review each year. Recognizing the value of this review, the Pharmaceutical Research and Manufacturers of America (PhRMA) recently stated in its voluntary guiding principles on DTC advertising (see “PhRMA Guiding Principles; Direct to Consumer Advertisements About Prescription Medicines” at *http://www.phrma.org/files/DTCGuidingprinciples.pdf* ) that companies should submit all new DTC television advertisements to FDA before broadcasting them. In addition, FDAAA provides that FDA may require the submission of drug television advertisements for review before dissemination. However, this provision does not take effect until 180 days after FDAAA's enactment, and does not affect this user fee program, which only applies to voluntary submissions for advisory review. As FDA's DTC advisory review workload has grown, FDA's ability to keep pace with the demands for reviews has decreased, and the time it takes to review DTC materials submitted for advisory review, including television advertisements, has been increasing. The lack of timely, predictable FDA review times for DTC television advertisements has hindered companies' ability to accurately set timeframes for their marketing campaigns and has discouraged companies from taking advantage of the DTC advisory review process. III. DTC User Fee Program The DTC user fee program is available to companies interested in voluntarily submitting to FDA for advisory review a DTC television advertisement for any product that qualifies as a “prescription drug product,” as defined in 21 U.S.C. 379g(3). Under this program, a company that chooses to submit a DTC television advertisement for advisory review will be assessed two types of fees:

(1)A fee for each proposed DTC television advertisement submitted for advisory review prior to its initial public dissemination (“advisory review fee”) and

(2)a fee paid during the company's first year of participation in the program to establish a reserve fund (“operating reserve fee”). The decision to seek an advisory review from FDA remains voluntary. However, FDA will not accept for review any prescription drug DTC television advertisements voluntarily submitted by a company for advisory review unless the company has paid both fees. The payment of an advisory review fee under new section 736A of the act entitles a company to submit for advisory review by FDA one proposed predissemination DTC television advertisement, and one resubmission of the same proposed DTC television advertisement, after receipt of FDA advisory comments on the initial submission. It should be noted that fees will not be assessed for advertisements required to be submitted to FDA prior to initial public dissemination, such as advertisements for accelerated approval drugs (21 CFR 314.550 and 314.640 (subparts H and I)), biologics (21 CFR 601.45 and 601.94 (subparts E and H)), and submissions required by the Secretary under section 901 of FDAAA (as it amends the act to add section 503B, “Prereview of Television Advertisements”), unless the sponsor voluntarily designates the required submission as a submission for advisory review under this program. Fees also will not be assessed for advisory reviews of advertising or promotional material other than DTC television advertisements (e.g., print advertisements or promotional labeling). The user fees associated with this program are structured to provide incentives for companies to join the program in FY 2008 and to pay all fees on time, as this will give FDA the funding it needs to hire sufficient staff to review the identified number of advisory submissions in FY 2008. FDA will recruit staff to conduct reviews based upon the expected number of submissions for FY 2008 that are identified in response to this participation notice. Fees for FY 2008 must be paid in a timely manner to allow FDA to actually obtain these staffing resources to conduct timely reviews and meet performance metrics during this year. In addition, the program contains incentives for timely participation and payment. Participants who do not pay their fees on time or who join the program late in a fiscal year must pay individual fees that are 50 percent greater than the established individual fees for participants who both join the program and pay on time. IV. Establishing the Advisory Review Fee A. Process Congress directed FDA to issue a **Federal Register** notice, not later than 30 days after enactment of FDAAA, asking companies to indicate whether they intend to participate in the DTC user fee program by voluntarily submitting for FDA advisory review DTC television advertisements for prescription drugs during FY 2008. Companies that indicate they intend to participate must specify the number of advertisements they intend to submit in FY 2008. Once companies have responded to this notice, FDA will issue another **Federal Register** notice establishing the fee for each advisory review submission for FY 2008. B. Basis for the Fee The fee will be based on the number of advertisements identified in response to this participation notice. The advisory review fees in FY 2008 will be set at a level to generate target revenues of $6.25 million in the first year of the program. Individual fees will be determined by dividing the target revenue, established in the statute, by the number of proposed television advertisements that all companies have indicated (in response to the participation notice) that they intend to submit during FY 2008. For example, if companies indicate that they intend to submit 150 total advertisements, the fee for each advisory review submission will be $41,667 ($6.25 million divided by 150). The statute limits this fee to no more than $83,000 per submission for FY 2008. This limitation is one of several provisions in the statute that help ensure individual sponsors will not individually bear a disproportionate share of the cost of the program. The target revenue figures will be adjusted annually for inflation and workload in subsequent years. In each subsequent fiscal year of the program, FDA will issue a new request for notice of participation by June 1 of the previous fiscal year and a second notice by August 1 of the previous fiscal year establishing the fees for the fiscal year beginning October 1. C. Additional Submissions If, in response to this notice, a participant notifies FDA that it plans to submit a certain number of advertisements for FY 2008 and then exceeds that number of advertisements, the participant will be assessed a fee for each additional submission. The fee will be 50 percent greater than the established individual fee. In addition, a participant who does not pay the fees for which it is billed within the timeframe specified by the Secretary once the fees are set for FY 2008 will be assessed a penalty that is 50 percent greater than the established individual fee. D. Year-to-Year Carry Overs If a company identifies and pays for more advisory reviews than it submits in a given fiscal year, the company may carry over one paid submission for advisory review to the next fiscal year. This means that a submission for advisory review for which the fee was paid in 1 fiscal year can be submitted for advisory review in the following fiscal year. Companies cannot carry over more than one such submission to the next fiscal year; for unused submissions over and above the one available for carryover, the paid user fee will not be refunded, waived, exempted, or reduced. However, resubmissions are not subject to a fiscal year limitation. For example, a company can submit an advertisement for advisory review in fiscal year 2008 and resubmit a revised version of that same advertisement for advisory review in fiscal year 2009, at no additional cost. E. Operating Reserves To establish operating reserves for the program, in the first year of their participation in the program, participants will be assessed a one-time participation fee that will be based on the number of anticipated submissions the participant identifies for that year. In this way, FDA will collect additional revenues of $6.25 million to be placed in reserve from which funds can be drawn if target revenues fluctuate downward in subsequent years. For companies responding by November 26, 2007, the operating reserve fee for each participant in FY 2008 will be an amount equal to the total amount that company is charged for its annual advisory review fees for FY 2008. For companies who respond by November 26, 2007, but do not pay the assessed operating reserve fee within the timeframe specified by the Secretary, their operating reserve fee will be 50 percent higher than what they would have owed had they paid on time. For participants who join the program late in FY 2008, i.e., those who do not notify FDA of their intent to participate until after November 26, 2007, the operating reserve fee will be 50 percent higher than what they would have owed had they both notified FDA and paid on time. Companies who join the program in subsequent fiscal years (FYs 2009 to 2012) will be assessed an amount for the operating reserve fee that will be at least as much as the amount they would have been assessed if they had joined the program at the start of FY 2008. Specifically, in subsequent years, the operating reserve fee for new participants will be the higher of:

(1)The total amount of advisory review fees for all of the new participant's proposed DTC television advertisements in the fiscal year they join the program or

(2)the total amount of advisory review fees that would have been assessed in FY 2008 for that number of proposed DTC television advertisements. This statutory fee structure limits the incentive for companies to join the program late, which could prevent the program from receiving sufficient funding in the initial year and place a disproportionate share of the cost of the program on those participants who join the program in its initial year of operation. F. Effect of Inadequate Funding The statute provides that if FDA fails to receive sufficient funding from companies within 120 days after enactment of FDAAA, the program will not commence. Sufficient funding consists of a combined total amount of at least $11.25 million from advisory review fees and operating reserve fees. In the event that insufficient funding is received and the program does not commence, all collected fees will be refunded to the companies that paid. G. FDA Commitment The fees will be used to fund approximately 27 additional staff for predissemination advisory review of DTC television advertisements. These additional resources will enable FDA to provide more timely reviews of DTC television advertisements. FDA has committed to phased-in performance metrics. For example, assuming 150 submissions in FY 2008, FDA will review and provide advisory comments to the sponsor within 45 days on 50 percent of the 150 original submissions. In addition, FDA is committed to reviewing 50 percent of resubmissions within 30 days. The performance metrics will be phased in over the 5 years of the program, with each year including more stringent performance goals. V. Request for Notice of Participation FDA is asking companies that intend to submit advertisements to FDA for advisory review in FY 2008 to notify FDA by November 26, 2007 of:

(1)Their intent to submit advertisements for advisory review and

(2)the number of DTC television advertisements they plan to submit for advisory review during FY 2008. Notification of participation without specifying the number of DTC television advertisements to be submitted in FY 2008 will be considered an incomplete notification, and subsequent notification of intent to submit advertisements after November 26, 2007 would be treated as late. The agency requests that all companies submit their written responses within 30 calendar days (see DATES ) by overnight courier service to Wayne Amchin (see ADDRESSES ) and fax or e-mail a copy of their response (see ADDRESSES ). A. What Should Those Wishing To Participate Submit in Their Written Notification? The following information should be included in a company's DTC television advertisement written notification: • A statement that they will submit DTC television advertisements to FDA for advisory review during FY 2008, • The number of proposed DTC television advertisements they will submit for advisory review under the DTC user fee program in FY 2008, and • The name, title, billing address, and contact information (phone, e-mail, fax) of the company representative who will be the primary person for FDA to contact concerning the company's participation in the program. B. What Does Written Notification to FDA Mean? Each company's written notification to FDA of the number of DTC television advertisements it intends to submit for advisory review in FY 2008 is a legally binding commitment by that company to pay the FY 2008 advisory review fee for each submission (see section 736A(a)(1)(D)(ii) of the act). Each person who is assessed an advisory review fee is also required to pay an operating reserve fee for those submissions (a one-time fee in the first year of participation to fund the operating reserve) (see section 736A(a)(2) of the act). FDA will send invoices to each company for all submissions identified in response to this notice, and the advisory review fee and the operating reserve fee for all these submissions are due and payable on the date specified in the invoices. FDA will also assign each participant a series of unique user fee ID numbers to correspond with the number of advisory reviews that the participant identified in response to this notice. For example, a company identifying 10 advisory reviews will receive 10 unique user fee ID numbers in its invoice. Each submission of a DTC television advertisement for FDA advisory review will be identified with a user fee ID number to show that the fee has been paid. A company's request for advisory review will be considered incomplete and submissions will not be accepted for review until all fees owed by the company for all advisory reviews and the operating reserve fee have been paid (see section 736A(e) of the act). C. Can a Company Transfer or Sell its Remaining Balance of User Fee Credits to Another Company? For each advisory review fee paid by a person for a fiscal year, section 736A(a)(1)(F)(i) of the act provides that the person is entitled to acceptance for advisory review of one DTC advertisement and acceptance of one resubmission for advisory review of the same advertisement. Section 736A(a)(1)(F)(i) of the act further provides that the advertisement shall be submitted for review in the fiscal year for which the fee was assessed, except that a person may carry over not more than one paid advisory review submission to the next fiscal year. FDA will administratively keep track of these submissions as advisory review credits. Each credit for an advisory review will expire at the end of the fiscal year for which the user fees were paid, except that one unused credit can be carried over from the fiscal year in which it was purchased to the next fiscal year. Advisory review credits are not transferable, except to a successor in interest (see section 736A(a)(1)(F)(iv) of the act). If unexpired credits are transferred to a successor in interest, the successor company and former owner should notify FDA to ensure that future billing of the successor company reflects prior contributions to the DTC user fee program reserve fund and the unexpired credit balance. Evidence of a successor in interest could include a copy of the documentation required under 21 CFR 314.72. Please contact Wayne Amchin (see FOR INFORMATION CONTACT ) concerning successor in interest issues. Successors in interest with an unexpired credit balance should also be aware of the following: • One unused credit can be carried over from the fiscal year in which it was purchased to the next fiscal year. • In responding to the annual **Federal Register** notice for company participation, the successor company must indicate its intent to use the unexpired carryover credit in the upcoming fiscal year. D. How Do I Send in DTC Television Advertisements for Advisory Review Under the DTC User Fee Program? FDA intends to issue guidance to industry explaining how to submit DTC advisory review packages for review under the DTC user fee program. The guidance document will provide details on the contents, format, and procedures that FDA recommends be followed. The guidance will also explain how and where to submit advisory review packages to start the DTC user fee program performance clock. FDA will issue a **Federal Register** notice to announce the availability of this guidance. E. What Happens if I Send in a DTC Television Advertisement for Advisory Review After October 1, 2007, but Before I'm Invoiced by FDA for My FY 2008 Fees? The effective date for the assessment and collection of fees for DTC television advertisements under this program is October 1, 2007. Therefore, any DTC television advertisement submitted for advisory review in FY 2008 is subject to the previously discussed fees under this program. FDA recognizes that, because of the timing of the enactment of FDAAA, the advisory review and operating reserve fees for FY 2008 were not established and billed before October 1, 2007, and that there will be a gap between the start of the fiscal year and the date that fees are due. However, the voluntary submission of a DTC television advertisement for FDA advisory review on or after October 1, 2007, but before November 26, 2007 will be considered by FDA as notification that the company who submitted the advertisement wishes to participate in the program and agrees to pay the advisory review fee and operating reserve fee for each such submission in a timely manner once the fees for FY 2008 are established and the company is invoiced. Companies who submit DTC television advertisements for advisory review in this period should respond to this participation notice, and include any such submissions in their count of the total number of advisory submissions they intend to submit in FY 2008. FDA will also contact companies who submit DTC television advertisements in this time period to request written confirmation from these companies of their commitment to pay these fees; if companies do not agree to make this commitment, FDA will request that they withdraw their submission(s), and such submissions will not be reviewed. For companies who do agree, FDA will begin its advisory review of a complete submission of a DTC television advertisement for advisory review on the date that it receives written confirmation of the company's commitment to pay the fees associated with the submission in a timely manner once the company is invoiced. For information on how FDA will treat DTC television advertisement advisory review submissions not identified in response to this notice that are submitted after November 26, 2007, see sections IV.C “Additional Submissions” and IV.E “Operating Reserves” of this document. Dated: October 19, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 07-5282 Filed 10-24-07; 8:45 am]

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