Notices. Notice; reopening of comment period

9,766 words·~44 min read·/register/2007/07/19/07-3507

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

BILLING CODE 6715-07-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30 Day-07-0007] Agency Forms Undergoing Paperwork; Reduction Act Review The Centers for Disease Control and Prevention

(CDC)publishes a list of information collection requests under review by the Office of Management and Budget

(OMB)in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at

(404)639-5960 or send an e-mail to: *omb@cdc.gov.* Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to

(202)395-6974. Written comments should be received within 30 days of this notice. Proposed Project Weekly and Annual Morbidity and Mortality Reports, 0920-0007-Extension—National Center for Health Marketing (NCHM), Centers for Disease Control and Prevention (CDC). Background and Brief Description The Centers for Disease Control and Prevention

(CDC)is responsible for the collection and dissemination of nationally notifiable diseases' information and for monitoring and reporting the impact of epidemic influenza on mortality, Public Health Service Act (42 U.S.C. 241). In 1878, Congress authorized the U. S. Marine Hospital Service (later renamed the U.S. Public Health Service) to collect morbidity reports on cholera, smallpox, plague, and yellow fever from U.S. consuls overseas; this information was to be used for instituting quarantine measures to prevent the introduction and spread of these diseases into the United States. In 1879, a specific Congressional appropriation was made for the collection and publication of reports of these notifiable diseases. Congress expanded the authority for weekly reporting and publication in 1893 to include data from state and municipal authorities throughout the United States. To increase the uniformity of the data, Congress enacted a law in 1902 directing the Surgeon General of the Public Health Service

(PHS)to provide forms for the collection and compilation of data and for the publication of reports at the national level. Reports on notifiable diseases were received from very few states and cities prior to 1900, but gradually more states submitted monthly and annual summaries. In 1912, state and territorial health authorities—in conjunction with PHS—recommended immediate telegraphic reports of five diseases and monthly reporting by letter of 10 additional diseases, but it was not until after 1925 that all states reported regularly. In 1942, the collection, compilation, and publication of morbidity statistics, under the direction of the Division of Sanitary Reports and Statistics, PHS, was transferred to the Division of Public Health Methods, PHS. A PHS study in 1948 led to a revision of the morbidity reporting procedures, and in 1949 morbidity reporting activities were transferred to the National Office of Vital Statistics. Another committee in PHS presented a revised plan to the Association of State and Territorial Health Officers (ASTHO) at its meeting in Washington, DC, October 1950. ASTHO authorized a Conference of State and Territorial Epidemiologists

(CSTE)for the purpose of determining the diseases that should be reported by the states to PHS. Beginning in 1951, national meetings of CSTE were held every two years until 1974, then annually thereafter. In 1961, responsibility for the collection of data on nationally notifiable diseases and deaths in 122 U.S. cities was transferred from the National Office of Vital Statistics to CDC. For over 40 years the Morbidity and Mortality Weekly Report

(MMWR)has consistently served as the CDC premier communication channel for disease outbreaks and trends in health and health behavior. The data collected for publication in the MMWR provides information which CDC and State epidemiologists use to detail and more effectively interrupt outbreaks. Reporting also provides the timely information needed to measure and demonstrate the impact of changed immunization laws or a new therapeutic measure. Users of data include, but are not limited to, congressional offices, state and local health agencies, health care providers, and other health related groups. The dissemination of public health information is accomplished through the MMWR series of publications. The publications consist of the MMWR, the CDC Surveillance Summaries, the Recommendations and Reports, and the Annual Summary of Notifiable Diseases. There are no costs to respondents except their time to participate in the survey. The total estimated burden hours are 4,927. Estimated Annualized Burden Hours Respondents Number of respondents Number of responses per respondent Average burden per respondent (in hours) States 50 52 1 Territories 4 52 1 1 52 30/60 Cities 2 52 1 Subtotals 57 City health officers or Vital statistics registrars 122 52 12/60 States 50 1 14 Territories 5 1 14 Cities 2 1 14 Subtotals Totals 179 Dated: July 13, 2007. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E7-13985 Filed 7-18-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N-0349] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; FDA Survey of Current Manufacturing Practices in the Food Industry AGENCY: Food and Drug Administration, HHS. ACTION: Notice; reopening of comment period. SUMMARY: The Food and Drug Administration

(FDA)is reopening until September 17, 2007, the comment period for a notice that published in the **Federal Register** of May 8, 2007 (72 FR 26132). In the notice, FDA announced that a proposed collection of information had been submitted to the Office of Management and Budget

(OMB)for review and clearance under the Paperwork Reduction Act of 1995 (the PRA). FDA is reopening the comment period in light of continued public interest in this collection of information and in response to a request for an extension of the comment period for this notice. DATES: Fax written comments on the collection of information by September 17, 2007. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974, or e-mailed to *baguilar@omb.eop.gov* . All comments should be identified with the OMB control number “0910-NEW” and title “FDA Survey of Current Manufacturing Practices in the Food Industry.” Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: In the **Federal Register** of May 8, 2007 (72 FR 26132), FDA solicited comments on a proposed collection of information that the agency had submitted to OMB for review and clearance under the PRA. Interested persons were given until June 7, 2007, to submit written comments by fax directly to OMB. As a result of continued public interest, and in response to a request to extend the comment period by 60 days, FDA is reopening the comment period until September 17, 2007, to allow interested persons additional time to submit comments to OMB. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. FDA Survey of Current Manufacturing Practices in the Food Industry—(OMB Control Number 0910-NEW) The authority for FDA to collect the information derives from the FDA Commissioner's authority, as specified in section 903(d)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)). FDA's regulations in part 110 (21 CFR part 110) describe the methods, equipment, facilities and controls for producing processed food, hereafter referred to as food current good manufacturing practices (CGMPs). As the minimum sanitary and processing requirements for producing safe and wholesome food, CGMPs are an important part of regulatory control of the nation's food supply. FDA believes that it is necessary to revisit and modernize the food CGMPs. Since the food CGMPs were last revised in 1986, there have been significant changes in food production technology and important advances in the understanding of foodborne illnesses. Accordingly, the agency will rigorously assess the impacts of any modernization policies on food facilities. To assess the impacts of the modernization policy, information is needed to help understand baseline or current industry practice. At present, however, FDA lacks baseline information on the nature of current manufacturing practices that would serve as part of a regulatory impact analysis. FDA plans to conduct an Internet survey of all domestic FDA-registered facilities that primarily manufacture or process food and all foreign FDA-registered facilities that primarily manufacture or process food, which are located in those countries that are the largest food exporters to the United States: Japan, Canada, China, France, Italy, and Mexico. The Internet survey may be supplemented by extended case study interviews with selected respondents from the survey. The survey and extended case studies will solicit detailed information about six key topics relevant to the food CGMPs modernization effort: Employee training, sanitation and personal hygiene, allergen controls, process controls, post-production processing, and recordkeeping. Additionally, FDA will collect information on establishment characteristics, such as facility size and industry, which are expected to correlate with the presence or absence of various manufacturing practices, such as electronic recordkeeping, ongoing employee training in food safety, and product-to-label conformance procedures. The case study interviews, if conducted, will provide qualitative, indepth information about various factors that influence decisions to implement these types of manufacturing practices, as well as about the circumstances that underlie the cost and effectiveness of such programs. The survey will be sent to every FDA-registered facility in the United States, Japan, Canada, China, France, Italy, and Mexico that primarily manufactures or processes food products and that included an e-mail address with their registration. Participation will be voluntary and the respondent identifiers that would permit an association of specific responses to specific respondents will not be accessible to FDA. The proposed Internet survey will collect the information from respondents electronically. With a custom-designed online survey system, responses will be entered directly into a computer database, eliminating the need for additional coding and data entry operations. Also, the system will ensure that conditional questions are asked in proper order, freeing the respondent from the need to keep track of the question order and skip patterns. The data quality will also be higher because the instrument will contain built-in edits, prompts, and data validation features. The Internet survey method was selected due to the following considerations:

(1)E-mail addresses of the respondents are available from the FDA Food Facility Registration database and are continuously validated by FDA;

(2)the Internet survey method is the least costly to the agency when compared with other modes of collection and generates the timeliest responses;

(3)the Internet survey will impose a relatively modest reporting burden on small entities; and

(4)the Internet survey method is the only feasible method by which FDA may survey foreign facilities that export food products to the United States. The Internet survey includes a pledge of confidentiality regarding the contractor's use of the data provided by the respondents. All data will be collected and compiled by Eastern Research Group, Inc. (ERG), an independent consulting firm contracted by FDA. ERG will provide FDA personnel only with a summary of data (aggregated statistical data) compiled in the course of the study. No reports will have information about individual facility's participation or lack of participation, or information that enables FDA to determine individual responses. In keeping with longstanding FDA practice, ERG will not provide FDA with identifiers that would permit the association of specific responses with a given respondent. Responses will not be the property of the Federal Government. The raw data generated by the Food CGMP Survey will not be owned by FDA, will not be an FDA record, and will not be provided, or otherwise made available, to FDA. The key information to be collected includes responses to questions about the following:

(1)Training procedures and practices for food production managers, production supervisors, quality control personnel, sanitation and cleaning supervisors and production line employees on the topics of food safety, basic cleaning, sanitizing, sanitation, personal hygiene, specific product and equipment training and allergen control;

(2)pest control and sanitation procedures and practices for food contact surfaces, non-food contact surfaces, production areas and warehouses;

(3)allergen control procedures and practices for soybean or soybean-based ingredients, peanuts or peanut-based ingredients, finfish and crustacea, tree nuts, milk and other diary products, eggs, and wheat or wheat-based products;

(4)process controls, including written procedures for handling incoming raw materials, approving vendors, the calibration of operating equipment, pathogen control, and a Hazard Analysis and Critical Control Point system;

(5)recordkeeping practices;

(6)the primary operation characteristics conducted at the facility, such as the type of food manufactured or processed for human consumption; and

(7)fresh produce and ready to eat packing practice and post-harvest operations. In the **Federal Register** of September 14, 2005 (70 FR 54390), FDA published a 60-day notice requesting public comment on the information collection provisions. We received comments from three respondents on the 60-day notice regarding FDA's survey of current manufacturing practices in the food industry. One of the respondents' comments was received after the 60-day comment period closed and is not addressed. Respondents were asked to submit comments pertaining to:

(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. Comments outside the scope of these four questions are not addressed in this notice. (Comment 1) One industry respondent wanted assurances from FDA that individual company information was not subject to release under the Freedom of Information Act (FOIA). (Response) The Internet survey includes a pledge of confidentiality regarding the data provided by the respondent. All data will be collected, compiled, and owned by ERG, an independent consulting firm contracted by FDA. ERG is contractually obligated to retain the raw data and to not provide FDA with access to it. ERG will provide FDA personnel only with anonymous summary and aggregate statistical data compiled during the course of the study; ERG is contractually restricted from providing FDA with raw or other data that has identifiers that would permit the association of specific responses to a given respondent. Data that FDA does not own cannot be requested through FOIA. (Comment 2) The respondent requests that only one contact be made for each individual firm through the parent company contact listed on the firm's facility registration form and not to each location where the firm has a production facility. (Response) We recognize the additional burden this places on a firm but because we need current information from each manufacturing plant we do not believe that we have an alternative approach. Not every facility processes the same types of foods with the same preventive controls even when the parent company is the same. We need to get an idea of CGMPs at each facility location. Having a parent company respond could give us inaccurate information. (Comment 3) The respondent requests that each firm (facility) receive only one solicitation for information. (Response) Response to this survey is voluntary. For the sake of statistical reliability, we must contact non-responders more than just initially or our survey data result could be subject to a non-response bias. Non-response bias is affected by both the proportion of non-responders and the extent to which non-respondents and respondents differ on key questions being measured in the survey. To reduce the bias, it is necessary to reduce the number of non-responders by contacting them multiple times. It also helps to obtain information about non-responders to assess whether their sociodemographic characteristics differ systematically from survey responders. Survey researchers should always try to followup with individuals who do not consent to participate in a survey and ascertain their reasons for non-response. We do recognize that there should be an upper limit for the number of times a non-responder should be contacted before being dropped. From our experience, data quality will not be improved significantly by more than six contacts, so we will set our upper limit at six contacts. (Comment 4) One respondent opposes investigating foreign manufacturers. (Response) We are not investigating foreign manufacturers; we are surveying them to get an idea about their manufacturing practices. Nearly 20% of all imports into the United States are food and food products; imported fresh produce and seafood make up a large percentage of these imports. All food, including imported and domestic food, must follow the same manufacturing regulations, thus information on foreign manufacturing processes is necessary and relevant to help inform us about how to modernize our regulation on CGMPs for food facilities. At that time of the 60-day notice, approximately 45,000 domestic and 55,000 foreign facilities were registered with FDA. Now approximately 126,000 domestic and 81,000 facilities from Japan, Canada, China, France, Italy, and Mexico are registered with FDA.Recent experience with online surveys has shown that fewer respondents respond than estimated at the time of the 60-day notice. Estimates of public burden have been adjusted to account for the increase in respondents and our estimate of the decrease in response rate. 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 *Domestic Facilities* Screening questions only 17,000 1 17,000 .067 1,139 Completed Survey 44,500 1 44,500 .75 33,375 **Total Domestic** 61,500 61,500 34,514 *Foreign Facilities* Screening questions only 14,000 1 14,000 .067 938 Completed Survey 26,000 1 26,000 .75 19,500 **Total Foreign** 40,000 1 40,000 20,438 **Grand Total** 101,500 54,952 1 There are no capital costs or operating and maintenance costs associated with this collection of information. These estimates of the number of respondents and the burden hours per response are based on FDA's registration database and FDA and the contractor's experience with previous surveys. The respondents are divided into two groups: Domestic and foreign. We estimate the number of domestic facilities at 126,000 based on information in the registration database. However, we do not expect that all of these firms will participate in the survey. We anticipate that approximately 61,500 facilities will participate, which takes into account typical response rates to these types of surveys and inaccurate contact information that facilities have entered into the registration database (see *http://www.cfsan.fda.gov/furls/ffregacc.html* ). Similarly, among the 81,000 foreign facilities in the registration database, we expect that 40,000 foreign facilities will respond. We estimate that it will take a respondent 4 minutes (.067 hours) to complete the screening questions and 45 minutes (0.75 hours) to complete the entire survey. Prior to the administration of the survey, the agency plans to conduct a pretest of the final survey to identify and resolve potential problems. The pretest will be conducted with nine participants. Dated: July 12, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-13951 Filed 7-18-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0037] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Experimental Study of Trans Fat Claims on Foods AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a collection of information entitled “Experimental Study of *Trans* Fat Claims on Foods” 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 December 15, 2006 (71 FR 75554), 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 0910-0533. The approval expires on June 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: July 12, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-14010 Filed 7-18-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0036] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosures on the Nutrition Facts Panel AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a collection of information entitled “Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative *Trans* Fat Disclosures on the Nutrition Facts Panel” 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 March 7, 2007 (72 FR 10220), 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 0910-0532. The approval expires on June 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: July 12, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-14011 Filed 7-18-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0278] Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary Registration of Cosmetic Product Establishments 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 voluntary registration of cosmetic product establishments with FDA. DATES: Submit written or electronic comments on the collection of information by September 17, 2007. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.fda.gov/dockets/ecomments* . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of 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. Voluntary Registration of Cosmetic Product Establishments—21 CFR Part 710 (OMB Control Number 0910-0027)—Extension The Federal Food, Drug, and Cosmetic Act (the act) provides FDA with the responsibility for assuring consumers that cosmetic products in the United States are safe and properly labeled. Cosmetic products that are adulterated under section 601 of the act (21 U.S.C. 361) or misbranded under section 602 of the act (21 U.S.C. 362) may not be distributed in interstate commerce. To assist FDA in carrying out its responsibility to regulate cosmetics, FDA has developed the Voluntary Cosmetic Registration Program (VCRP). In 21 CFR part 710, FDA requests that establishments that manufacture or package cosmetic products register with the agency on Form FDA 2511 entitled “Registration of Cosmetic Product Establishment.” The term “Form FDA 2511” refers to both the paper and electronic versions of the form. The electronic version of Form FDA 2511 is available on FDA's VCRP Web site at *http://www.cfsan.fda.gov/~dms/cos-regn.html* . FDA's online registration system, intended to make it easier to participate in the VCRP, was made available industry-wide on December 1, 2005. The agency strongly encourages electronic registration of Form FDA 2511 because it is faster and more convenient. A registering facility will receive confirmation of electronic registration, including a registration number, by e-mail, usually within 7 business days. The online system also allows for amendments to past submissions. Submission of the paper version of Form FDA 2511 remains an option as described in *http://www.cfsan.fda.gov/~dms/cos-reg2.html* . However, due to the high volume of online participation, the VCRP is allocating its limited resources primarily to electronic registrations. Because registration of cosmetic product establishments is not mandatory, voluntary registration provides FDA with the best information available about the locations, business trade names, and types of activity (manufacturing or packaging) of cosmetic product establishments. FDA places the registration information in a computer database and uses the information to generate mailing lists for distributing regulatory information and for inviting firms to participate in workshops on topics in which they may be interested. FDA also uses the information for estimating the size of the cosmetic industry and for conducting onsite establishment inspections. Registration is permanent, although FDA requests that respondents submit an amended Form FDA 2511 if any of the originally submitted information changes. FDA estimates the burden of this information collection as follows: **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Part Form No. of Respondents Annual Frequency per Respondent Total Annual Responses Hours per Response Total Hours 710 FDA 2511 135 1 135 0.2 27 1 There are no capital costs or operating and maintenance costs associated with this collection of information. FDA bases its estimate on its review of the registrations received over the past 3 fiscal years. The total annual responses (averaged over fiscal years 2004 through 2006) is 9 times the previous total reported in 2004 (for fiscal years 2000 through 2003) due to increased participation by cosmetic companies, because of a renewed industry commitment to the program, and implementation of the online registration system on December 1, 2005. Due to the ease of online registration, FDA estimates that the hours per response have declined from 0.4 hours to 0.2 hours. Thus, the total estimated hour burden for this information collection is 27 hours, which is 4.5 times the previous level reported in 2004. Dated: July 13, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-14013 Filed 7-18-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0527] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Threshold of Regulation for Substances Used in Food-Contact Articles AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a collection of information entitled “Threshold of Regulation for Substances Used in Food-Contact Articles” 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 March 22, 2007 (72 FR 13499), 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 0910-0298. The approval expires on June 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: July 12, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-14014 Filed 7-18-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0283] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; FDA Survey of Physicians' Perceptions of the Impact of Early Risk Communication About Medical Products AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

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

(OMB)for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by August 20, 2007. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974, or e-mailed to *baguilar@omb.eop.gov* . All comments should be identified with the OMB control number “0910-NEW” and title, “FDA Survey of Physicians' Perceptions of the Impact of Early Risk Communication about Medical Products.” Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. FDA Survey of Physicians' Perceptions of the Impact of Early Risk Communication about Medical Products (OMB Control Number 0910-NEW) The authority for FDA to collect the information derives from the FDA Commissioner's authority, as specified in section 903(d)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)). FDA engages in a number of communication activities to inform health care providers about new risks of regulated medical products, including prescription drugs, biologics, and medical devices (for example, pacemakers, implantable cardiac defibrillators, contact lenses, infusion pumps). More recently, FDA's communication activities have also included the general public. Activities include, but are not limited to, communications in medical journals, through the press (press releases, public health advisories), letters to health care providers sent out in cooperation with product manufacturers, and notifications and information sheets about recalls, withdrawals, and new product safety information on FDA's Internet site. Extensive publicity regarding serious side effects from certain commonly used prescription drugs, as well as certain implantable medical devices, has spurred public pressure to make risk information available sooner. In opposition to such public pressures, however, at least some prescribers and medical societies have suggested that early disclosure of potential side effects (emerging risks) may have unintended negative effects on patient care. For FDA to plan informed programmatic communication activities we need better empirical data about the impact of disseminating emerging risk information on providers and patient care. In addition, only limited research addresses specific barriers to physicians reporting patient adverse events either to FDA or product manufacturers. Further, we have no data evaluating FDA's efforts to improve reporting. Given differing perspectives on the value and timing of providing risk information to medical experts and the public at large, FDA believes it is important to assess how well it is communicating with physicians--the health care provider group with primary responsibility for deciding whether to use medical products to address patient problems. This information is critical both to plan programmatic communication activities and to improve the effectiveness of our reporting systems. Therefore, FDA plans to conduct a survey of a nationally representative group of physicians about these issues. The survey will collect information from respondents through computer-assisted telephone interviews conducted by experienced interviewers. FDA expects to have a final sample of 900 physicians, broken down approximately half and half between primary care practitioners (general practice, family practice, general internal medicine, and pediatricians) and specialists. The physician specialty groups identified for inclusion in the survey are office-based allergists, dermatologists, endocrinologists, nephrologists, certain oncologists, ophthalmologists, certain surgeons, psychiatrists, pulmonologists and rheumatologists. These groups were chosen to provide a reasonable cross-section of specialists who use both drugs and medical devices that might have been the focus of relatively recent publicity concerning emerging risk information. Procedures will be used to ensure production of a sample of physicians that is reasonably representative of the population within the United States. The design of the interview questions will be guided by the results of a series of 6 physician focus groups. The interview will take approximately 15 minutes to administer. Key information to be collected includes the following topics: 1. The impact on physicians, their patients, and their practices of the disclosure of still uncertain, emerging risks associated with medical products. 2. How physicians currently receive and ideally would like to receive new risk information about medical products (for example, at what level of certainty regarding causality and through what communication channels). 3. How physicians perceive the trustworthiness of FDA and other potential sources of risk information, including product sponsors, medical societies, and the media. 4. What FDA might do to increase the likelihood that respondents will report to FDA or to manufacturers serious patient reactions that might be side effects of using medical products. In the **Federal Register** of July 31, 2006 (71 FR 43200), FDA published a 60-day notice requesting public comment on the information collection provisions. Comments were received from five public entities consisting of two corporations and three associations. Comments supported FDA's belief in the value of conducting the survey. None of the comments addressed specific survey questions. FDA agrees with the comments concerning the study methodology. • Questions should be clear and not leading or ambiguous. • FDA should conduct pre-tests. • The sample size will be sufficient to provide statistically relevant information for the two stratified segments of physicians and the combination of these segments. After carefully considering them, FDA determined that other comments would require changes that would reduce the utility of study results by diluting the study's focus, omitting important topic areas, or making the questionnaire excessively long and thereby reducing response rates. These comments included the following: • Including other health care providers “who prescribe drugs.” • Getting more detail about particular source categories. • Omitting questions about how respondents report adverse events or product problems. FDA agreed with the value of adding some questions that ask about the inclusion of other information, including benefits, in communications about newly emerging product risks. FDA also received feedback from experts in the fields of risk communication and health literacy on the study and the proposed questionnaire at an “Effective Risk Communication” Think Tank Workshop. FDA revised the survey questionnaire in response to this feedback, the feedback received through the public comments, and eight cognitive interviews conducted in May 2007. **Table 1.—Estimated Annual Reporting Burden** 1 No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 27 (Pretests) 1 27 .3 8.1 1,000 (Screener) 1 1,000 .025 25.0 900 (Survey) 1 900 .25 225.0 Total 258.1 1 There are no capital costs or operating and maintenance costs associated with this collection of information. These estimates are based on FDA's and the contractor's experience with previous surveys. The respondents are divided into two groups: Primary care physicians and specialist physicians. We are basing this estimate on 90 percent of the screened physicians being eligible to participate in the survey. Prior to administering the survey with the entire sample, FDA plans to conduct pretests with up to 27 physicians; these are meant to evaluate the clarity and consistency of the survey questionnaire and interview protocol. Dated: July 13, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-14015 Filed 7-18-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007P-0052] Determination That Brethine (Terbutaline Sulfate) Injection Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing its determination that Brethine (Terbutaline Sulfate) Injection was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for terbutaline sulfate injection if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Carol E. Drew, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is a version of the drug that was previously approved under a new drug application (NDA). ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of an NDA. The only clinical data required in an ANDA are data to show that the drug that is the subject of the ANDA is bioequivalent to the listed drug. The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). Regulations also provide that the agency must make a determination as to whether a listed drug was withdrawn from sale for reasons of safety or effectiveness before an ANDA that refers to that listed drug may be approved (§ 314.161(a)(1) (21 CFR 314.161(a)(1))). FDA may not approve an ANDA that does not refer to a listed drug. On February 9, 2007, West-ward Pharmaceutical Corp. (West-ward), on behalf of Hikma Farmaceutica (Portugal), S.A., submitted a citizen petition (Docket No. 2007P-0052/CP1) to FDA under 21 CFR 10.30. The petition requests that the agency determine whether Brethine (terbutaline sulfate) injection (NDA 18-571), manufactured by AaiPharma, was withdrawn from sale for reasons of safety or effectiveness. AaiPharma ceased manufacture of Brethine injection and it was moved from the prescription drug product list to the “Discontinued Drug Product List” section of the Orange Book in August of 2006. Brethine injection was first approved in 1981; this approval was for a glass ampoule container closure system. In 2004 AaiPharma received approval of a glass vial container closure system for a Brethine injection formulation that contained 0.055 percent disodium edetate. When Brethine injection was discontinued, an approved generic was chosen as the replacement reference listed drug. The replacement reference listed drug does not contain 0.055 disodium edetate and is based on the original glass ampoule formulation. Therefore, West-ward requests that the agency make a determination that the reformulated version of Brethine injection was not withdrawn for safety or efficacy reasons. FDA has reviewed its records and, under § 314.161, has determined that Brethine (terbutaline sulfate) injection was not withdrawn from sale for reasons of safety or effectiveness. The petitioner identified no data or other information suggesting that Brethine containing 0.055 disodium edetate was withdrawn for reasons of safety or effectiveness. FDA has independently evaluated relevant literature and data for possible postmarketing adverse events and has found no information that would indicate that this product was withdrawn from sale for reasons of safety or effectiveness. Furthermore we have determined that the change in formulation was not for safety or efficacy reasons. Our files indicate that disodium edetate was added as a protectant against certain oxidation-derived terbutaline impurities and degradants when the manufacturing site and container closure system were changed. Accordingly, the agency will continue to list terbutaline sulfate injection in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to terbutaline sulfate injection may be approved by the agency if all other legal and regulatory requirements for the approval of ANDAs are met. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: July 12, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-13950 Filed 7-18-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D-0201] Draft Guidance for Industry and Food and Drug Administration Staff; Premarket Notification Submissions for Medical Devices That Include Antimicrobial Agents; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of the draft guidance entitled “Premarket Notification (510(k)) Submissions for Medical Devices That Include Antimicrobial Agents.” This draft guidance is intended to assist device manufacturers interested in preparing premarket notification (510(k)) submissions for their medical devices that include antimicrobial agents. This guidance recommends testing and labeling for 510(k) submissions for devices that include antimicrobial agents. It is intended as a supplement to other device-specific guidance issued by the Center for Devices and Radiological Health (CDRH). DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by October 17, 2007. ADDRESSES: Submit written requests for single copies of the draft guidance document entitled “Premarket Notification (510(k)) Submissions for Medical Devices That Include Antimicrobial Agents” to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 240-276-3151. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written comments concerning this draft 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.fda.gov/dockets/ecomments* . Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Michelle Rios, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3747. SUPPLEMENTARY INFORMATION: I. Background In recent years there has been increased interest in adding antimicrobial agents to medical devices for specific or limited indications for use, such as reduction or prevention of a device-related infection, or reduction or inhibition of colonization of a medical device. FDA developed this draft guidance to assist device manufacturers in preparing premarket notification (510(k)) submissions for medical devices that include antimicrobial agents. II. Significance of Guidance This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized will represent the agency's current thinking on “Premarket Notification (510(k)) Submissions for Medical Devices That Include Antimicrobial Agents.” 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 statute and regulations. III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. To receive “Premarket Notification (510(k)) Submissions for Medical Devices That Include Antimicrobial Agents,” you may either send an e-mail request to *dsmica@fda.hhs.gov* to receive an electronic copy of the document or send a fax request to 240-276-3151 to receive a hard copy. Please use the document number 1557 to identify the guidance you are requesting. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, **Federal Register** reprints, information on premarket submissions (including lists of approved applications and manufacturers' addresses), small manufacturer's assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH Web site may be accessed at *http://www.fda.gov/cdrh* . A search capability for all CDRH guidance documents is available at *http://www.fda.gov/cdrh/guidance.html* . Guidance documents are also available on the Division of Dockets Management Internet site at *http://www.fda.gov/ohrms/dockets* . IV. Paperwork Reduction Act of 1995 This draft 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 part 807 have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 801 have been approved under OMB control number 0910-0485. V. Comments 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. Dated: July 12, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-13952 Filed 7-18-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D-0252] Draft Guidance for Industry and Food and Drug Administration Staff; Pulse Oximeters—Premarket Notification Submissions [510(k)s]; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of the draft guidance entitled “Pulse Oximeters—Premarket Notification Submissions [510(k)s].” The draft guidance describes FDA's recommendations about the content of premarket notification submissions (510(k)s) for pulse oximeter devices. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115 (g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by October 17, 2007. ADDRESSES: Submit written requests for single copies of the draft guidance document entitled “Pulse Oximeters—Premarket Notification Submissions [510(k)s]” to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 240-276-3151. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written comments concerning this draft 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.fda.gov/dockets/ecomments* . Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Neel J. Patel, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3700. SUPPLEMENTARY INFORMATION: I. Background A pulse oximeter is a device intended for the non-invasive measurement of arterial blood oxygen saturation and pulse rate. It is a class II device in accordance with 21 CFR 870.2700. The draft guidance describes FDA's recommendations about the accuracy, performance, biocompatibility, safety, and labeling of pulse oximeters. In particular, the draft guidance incorporates the recommendations of the Anesthesiology and Respiratory Therapy Devices Panel (the Panel). At the open public meeting held on May 13, 2005, the Panel made recommendations regarding general issues for pulse oximeters, including reflectance sensor technology and the clinical validation of accuracy when the device is intended for neonatal use. FDA agreed and incorporated these recommendations into the draft guidance. (Transcripts of the May 13, 2005, meeting are available at *http://www.fda.gov/ohrms/dockets/ac/05/transcripts/2005-4141T1.htm* .) II. Significance of Guidance This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized will represent the agency's current thinking on “Pulse Oximeters—Premarket Notification Submissions [510(k)s].” 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 statute and regulations. III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. To receive “Pulse Oximeters—Premarket Notification Submissions [510(k)s],” you may either send an e-mail request to *dsmica@fda.hhs.gov* to receive an electronic copy of the document or send a fax request to 240-276-3151 to receive a hard copy. Please use the document number

(1605)to identify the guidance you are requesting. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, **Federal Register** reprints, information on premarket submissions (including lists of approved applications and manufacturers' addresses), small manufacturer's assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH Web site may be accessed at *http://www.fda.gov/cdrh* . A search capability for all CDRH guidance documents is available at *http://www.fda.gov/cdrh/guidance.html.* Guidance documents are also available on the Division of Dockets Management Internet site at *http://www.fda.gov/ohrms/dockets* . IV. Paperwork Reduction Act of 1995 This draft 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 part 807, subpart E, have been approved under OMB control number 0910-0120; and the collections of information in 21 CFR part 801 have been approved under OMB control number 0910-0485. V. Comments 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. Received 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. Dated: July 3, 2007. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E7-14012 Filed 7-18-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, Public Health Service, HHS. ACTION: Notice. SUMMARY: The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. ADDRESSES: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. Mice Genetically Deficient in the Chemoattractant Receptor FPR (Formyl Peptide Receptor) *Description of Invention:* The present research tool is a knockout mouse model (FPR -/- ) that lacks the high affinity N-formylpeptide receptor (FPR), created by targeted gene disruption. N-formylpeptides derive from bacterial and mitochondrial proteins, and bind to specific receptors on mammalian phagocytes. Since binding induces chemotaxis and activation of phagocytes in vitro, it has been postulated that N-formylpeptide receptor signaling in vivo may be important in antibacterial host defense, although direct proof has been lacking. The inventors have found that FPR -/- mice have no obvious developmental defects and do not develop spontaneous infection when derived in specific pathogen-free conditions. This suggests that, under these conditions, FPR is dispensable. However, when challenged with L. monocytogenes, FPR-deficient mice have accelerated mortality and increased bacterial burden in liver and spleen early after infection, which suggests a role for FPR in host defense, specifically through regulation of innate immunity. *Applications and Modality:* New mouse model to study antibacterial host defense. *Market:* Research tool useful for innate immunity studies. *Development Status:* The technology is a research tool. *Inventors:* Philip Murphy and Ji-Liang Gao (NIAID). *Patent Status:* HHS Reference No. E-258-2007/0—Research Tool. *Publication:* JL Gao, EJ Lee, PM Murphy. Impaired antibacterial host defense in mice lacking the N-formylpeptide receptor. J Exp Med. 1999 Feb 15;189(4):657-662. *Licensing Status:* This technology is not patented. The mouse model will be transferred through a Biological Materials License. *Licensing Contact:* Peter J. Soukas, J.D.; 301/435-4646; *soukasp@mail.nih.gov.* *Collaborative Research Opportunity:* The Laboratory of Molecular Immunology, NIAID, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize FPR knockout mice. Please contact Philip Murphy, M.D. at Tel: 301-496-8616 and/or *pmm@nih.gov* for more information. Steroid Derivatives as Inhibitors of Human Tyrosyl-DNA Phosphodiesterase

(Tdp1)*Description of Technology:* Tyrosyl-DNA phosphodiesterase

(Tdp1)is an enzyme that repairs topoisomerase I (Top1)-mediated DNA damage induced by chemotherapeutic agents and ubiquitous DNA lesions that interfere with transcription. The current technology are steroid derivatives that human inhibit Tdp1. Currently, there are various types of Top1 inhibitors used in chemotherapy, e.g., camptothecin. However, Tdp1 inhibitors are expected to be effective in combination therapy with Top1 inhibitors for the treatment of cancers. Combining Tdp1 inhibitors with Top1 inhibitors would allow Tdp1 to potentiate the antiproliferative activity of Top1 inhibitors. In addition to Tdp1's effect on Top1, Tdp1 inhibitors can also exhibit antitumor activity independently, as tumors are shown to have excess free radicals, and Tdp1 repairs DNA damage by oxygen radicals. *Applications and Modality:* It is anticipated that Tdp1 inhibitors in association with Top1 inhibitors can have selective activity toward tumor tissues. Tdp1 inhibitors may exhibit antitumor activity by themselves because tumors have excess free radicals. *Market:* 600,000 deaths from cancer related diseases were estimated in 2006. In 2006, cancer drug sales were estimated to be $25 billion. *Development Status:* The technology is currently in the pre-clinical stage of development. *Inventors:* Yves Pommier *et al.* (NCI). *Relevant Publication:* A manuscript directly related to the above technology will be available as soon as it is accepted for publication. *Patent Status:* U.S. Provisional Application No. 60/921,980 filed 05 Apr 2007 (HHS Reference No. E-130-2007/0-US-01). *Licensing Status:* Available for exclusive and non-exclusive licensing. *Licensing Contact:* Adaku Nwachukwu, J.D.; 301/435-5560; *madua@mail.nih.gov.* *Collaborative Research Opportunity:* The Center for Cancer Research, National Cancer Institute, Laboratory of Molecular Pharmacology is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize inhibitors of Tyrosyl-DNA phosphodiesterase (Tdp1). Please contact John D. Hewes, Ph.D. at 301-435-3121 or *hewesj@mail.nih.gov* for more information. Dated: July 9, 2007. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E7-13955 Filed 7-18-07; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental Health; 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 the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552(b)(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. *Name of Committee:* National Institute of Mental Health Special Emphasis Panel, Expedited Review of Tornado Survivors PTSD. *Date:* July 31, 2007. *Time:* 4 p.m. to 6 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call). *Contact Person:* Allan F. Mirsky, PhD, Scientific Review Administrator, Division of Extramural Activities, National Institute of Mental Health, NIH, Neuroscience Center, 6001 Executive Boulevard, Rm. 6157, MSC 9609, Bethesda, MD 20892-9609, 301-496-2551, *afmirsky@mail.nih.gov* . (Catalogue of Federal Domestic Assistance Program Nos. 93.242, Mental Health Research Grants; 93.281, Scientist Development Award, Scientist Development Award for Clinicians, and Research Scientist Award; 93.282, Mental Health National Research Service Awards for Research Training, National Institutes of Health, HHS) Dated: July 9, 2007. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 07-3507 Filed 7-18-07; 8:45 am]

Connectionstraces to 14

Traces to 14 documents

U.S. Code