Notices. Notice

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

BILLING CODE 4184-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Statement of Organization, Functions and Delegation of Authority Notice is hereby given that I have redelegated to the Regional Program Managers, Office of Child Support Enforcement, the following authorities vested in me by the Assistant Secretary of Administration for Children and Families in the memoranda dated February 16, 2007.

(a)Authorities Delegated. 1. The authority to approve Title IV-D State plans and amendments. 2. Authority to certify and transmit State requests for full collection services by the Secretary of Treasury and State applications to use courts of the United States to enforce court orders.

(b)Limitations. 1. These redelegations shall be exercised under financial and administrative requirements applicable to all Administration for Children and Families authorities. 2. The authority to approve Title IV-D State plans and amendments requires review and clearance by legal counsel and consultation with Central Office, Office of Child Support Enforcement, except as provided in written guidelines issued by the Commissioner. 3. These authorities may not be redelegated.

(c)Effective Date. This redelegation is effective on the date of signature.

(d)Effect on Existing Delegations. This redelegation of authority supersedes all previous delegations from the Deputy Director/Commissioner, Office of Child Support Enforcement, on these subjects. I hereby affirm and ratify any actions taken by any Regional Program Manager which, in effect, involved the exercise of these authorities prior to the effective date of this redelegation. Dated: May 10, 2007. Margot Bean, Deputy Director/Commissioner, Office of Child Support Enforcement. [FR Doc. E7-9671 Filed 5-18-07; 8:45 am] BILLING CODE 4184-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0278] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Continuous Marketing Applications: Pilot 2—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 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 June 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. All comments should be identified with the OMB control number 0910-0518. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Liz Berbakos, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,301-827-1482. 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. 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 (OMB Control Number 0910-0518)—Extension FDA is requesting OMB approval under the PRA (44 U.S.C. 3507) for the reporting and recordkeeping requirements contained in the guidance for industry entitled “Continuous Marketing Applications (CMA): Pilot 2—Scientific Feedback and Interactions During Development of Fast Track Products Under PDUFA.” This guidance discusses how the agency will implement a pilot program for frequent scientific feedback and interactions between FDA and applicants during the investigational phase of the development of certain Fast Track drug and biological products. Applicants are asked to apply to participate in the Pilot 2 program. In conjunction with the June 2002 reauthorization of the Prescription Drug User Fee Act of 1992 (PDUFA), FDA agreed to meet specific performance goals (PDUFA Goals). The PDUFA Goals include two pilot programs to explore the CMA concept. The CMA concept builds on the current practice of interaction between FDA and applicants during drug development and application review and proposes opportunities for improvement. Under the CMA pilot program, Pilot 2, certain drug and biologic products that have been designated as Fast Track (i.e., products intended to treat a serious and/or life-threatening disease for which there is an unmet medical need) are eligible to participate in the program. Pilot 2 is an exploratory program that allows FDA to evaluate the impact of frequent scientific feedback and interactions with applicants during the investigational new drug application

(IND)phase. Under the pilot program, a maximum of one Fast Track product per review division in FDA's Center for Drug Evaluation and Research

(CDER)and Center for Biologics Evaluation and Research

(CBER)is selected to participate. This guidance provides information regarding the selection of participant applications for Pilot 2, the formation of agreements between FDA and applicants on the IND communication process, and other procedural aspects of Pilot 2. FDA began accepting applications for participation in Pilot 2 on October 1, 2003. The guidance describes one collection of information: Applicants who would like to participate in Pilot 2 must submit an application (Pilot 2 application) containing certain information outlined in the guidance. The purpose of the Pilot 2 application is for the applicants to describe how their designated Fast Track product would benefit from enhanced communications between FDA and the applicant during the product development process. FDA's regulation at § 312.23 (21 CFR 312.23) states that information provided to the agency as part of an IND must be submitted in triplicate and with an appropriate cover form. Form FDA 1571 must accompany submissions under INDs. 21 CFR part 312 and FDA Form 1571 have a valid OMB control number: OMB control number 0910-0014, which expires May 31, 2009. In the guidance document, CDER and CBER ask that a Pilot 2 application be submitted as an amendment to the application for the underlying product under the requirements of § 312.23; therefore, Pilot 2 applications should be submitted to the agency in triplicate with Form FDA 1571. The agency recommends that a Pilot 2 application be submitted in this manner for two reasons:

(1)To ensure that each Pilot 2 application is kept in the administrative file with the entire underlying application and

(2)to ensure that pertinent information about the Pilot 2 application is entered into the appropriate tracking databases. Use of the information in the agency's tracking databases enables the agency to monitor progress on activities. Under the guidance, the agency asks applicants to include the following information in the Pilot 2 application: • Cover letter prominently labeled “Pilot 2 application”; • IND number; • Date of Fast Track designation; • Date of the end-of-phase 1 meeting, or equivalent meeting and summary of the outcome; • A timeline of milestones from the drug or biological product development program, including projected date of new drug application (NDA)/biologics license application submissions; • Overview of the proposed product development program for a specified disease and indication(s), providing information about each of the review disciplines (e.g., chemistry/manufacturing/controls, pharmacology/toxicology, clinical, clinical pharmacology and biopharmaceutics); • Rationale for interest in participating in Pilot 2, specifying the ways in which development of the subject drug or biological product would be improved by frequent scientific feedback and interactions with FDA and the potential for such communication to benefit public health by improving the efficiency of the product development program; and • Draft agreement for proposed feedback and interactions with FDA. This information is used by the agency to determine which Fast Track products are eligible for participation in Pilot 2. Participation in this pilot program is voluntary. Based on the number of Pilot 2 applications submitted to CDER and CBER during fiscal year 2004 and 2005, we estimate that the number of applications received annually for Pilot 2 is 7 for products regulated by CDER and 1 for products regulated by CBER. FDA anticipates that approximately 7 applicants (respondents) will submit these Pilot 2 applications annually to CDER and approximately 1 applicant (respondent) will submit these Pilot 2 applications annually to CBER. The hours per response, which is the estimated number of hours that a respondent would spend preparing the information to be submitted in a Pilot 2 application in accordance with the guidance, is estimated to be approximately 80 hours. Based on FDA's experience, we expect it will take respondents this amount of time to obtain and draft the information to be submitted with a Pilot 2 application. Therefore, the agency estimates that applicants use approximately 640 hours annually to submit the Pilot 2 applications. In the **Federal Register** of July 24, 2006 (71 FR 41819), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. **Table 1.—Estimated Annual Reporting Burden** 1 Pilot 2 Application No. of Respondents No. of Responses per Response Total Responses Hours per Response Total Hours CDER 7 1 7 80 560 CBER 1 1 1 80 80 Total 640 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: May 15, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-9709 Filed 5-18-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007E-0066] Determination of Regulatory Review Period for Purposes of Patent Extension; NOXAFIL AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)has determined the regulatory review period for NOXAFIL and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product. ADDRESSES: Submit written comments and petitions 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* . FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy (HFD-007), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the human drug product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA recently approved for marketing the human drug product NOXAFIL (posaconazole). NOXAFIL is indicated for prophylaxis of invasive *Aspergillus* and *Candida* infections in patients, 13 years of age and older, who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant recipients with Graft versus Host Disease or those with hematologic malignancies with prolonged neutropenia from chemotherapy. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for NOXAFIL (U.S. Patent No. 5,661,151) from Schering Corp., and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated March 12, 2007, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of NOXAFIL represented the first permitted commercial marketing or use of the product. Shortly thereafter, the Patent and Trademark Office requested that FDA determine the product's regulatory review period. FDA has determined that the applicable regulatory review period for NOXAFIL is 3,650 days. Of this time, 3,382 days occurred during the testing phase of the regulatory review period, while 268 days occurred during the approval phase. These periods of time were derived from the following dates: 1. *The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective* : September 19, 1996. The applicant claims November 6, 1996, as the date the investigational new drug application

(IND)became effective. However, FDA records indicate that the IND effective date was September 19, 1996, which was 30 days after FDA receipt of the first IND. 2. *The date the application was initially submitted with respect to the human drug product under section 505(b) of the act* : December 22, 2005. The applicant claims December 21, 2005, as the date the new drug application

(NDA)for NOXAFIL (NDA 22-003) was initially submitted. However, FDA records indicate that NDA 22-003 was submitted on December 22, 2005. 3. *The date the application was approved* : September 15, 2006. FDA has verified the applicant's claim that NDA 22-003 was approved on September 15, 2006. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,789 days of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments and ask for a redetermination by July 20, 2007. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by November 19, 2007. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: May 7, 2007. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E7-9730 Filed 5-18-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004E-0398] Determination of Regulatory Review Period for Purposes of Patent Extension; IRESSA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)has determined the regulatory review period for IRESSA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product. ADDRESSES: Submit written comments and petitions 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* . FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy (HFD-007), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the human drug product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA recently approved for marketing the human drug product IRESSA (gefitinib). IRESSA is indicated as monotherapy for the continued treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of both platinum-based and docetaxel chemotherapies who are benefiting or have benefited from IRESSA. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for IRESSA (U.S. Patent No. 5,770,599) from AstraZeneca UK Limited, and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated October 19, 2004, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of IRESSA represented the first permitted commercial marketing or use of the product. Thereafter, the Patent and Trademark Office requested that FDA determine the product's regulatory review period. FDA has determined that the applicable regulatory review period for IRESSA is 1,967 days. Of this time, 1,693 days occurred during the testing phase of the regulatory review period, while 274 days occurred during the approval phase. These periods of time were derived from the following dates: 1. *The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective* : December 17, 1997. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on December 17, 1997. 2. *The date the application was initially submitted with respect to the human drug product under section 505(b) of the act* : August 5, 2002. FDA has verified the applicant's claim that the new drug application

(NDA)for Iressa (NDA 21-399) was initially submitted on August 5, 2002. 3. *The date the application was approved* : May 5, 2003. FDA has verified the applicant's claim that NDA 21-399 was approved on May 5, 2003. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 374 days of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments and ask for a redetermination by July 20, 2007. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by November 19, 2007. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: May 7, 2007. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E7-9733 Filed 5-18-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2002E-0156] Determination of Regulatory Review Period for Purposes of Patent Extension; GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)has determined the regulatory review period for GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that medical device. ADDRESSES: Submit written comments and petitions 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* . FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy (HFD-007), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For medical devices, the testing phase begins with a clinical investigation of the device and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a medical device will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(3)(B). FDA recently approved for marketing the medical device, GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM. GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM is indicated to deliver beta radiation to the site of successful percutaneous coronary intervention

(PCI)for the treatment of in-stent restenosis in native coronary arteries with discrete lesions ≤ 47 millimeters

(mm)in a reference vessel diameter 2.4 mm to 3.7 mm. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM (U.S. Patent No. 5,199,939) from Guidant Corp., and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated October 31, 2002, FDA advised the Patent and Trademark Office that this medical device had undergone a regulatory review period and that the approval of GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM represented the first permitted commercial marketing or use of the product. Thereafter, the Patent and Trademark Office requested that FDA determine the product's regulatory review period. FDA has determined that the applicable regulatory review period for GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM is 1,523 days. Of this time, 1,203 days occurred during the testing phase of the regulatory review period, while 320 days occurred during the approval phase. These periods of time were derived from the following dates: 1. *The date an exemption under section 520(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360j(g)) involving this device became effective* : September 3, 1997. FDA has verified the applicant's claim that the date the investigational device exemption

(IDE)required under section 520(g) of the act for human tests to begin became effective September 3, 1997. 2. *The date the application was initially submitted with respect to the device under section 515 of the act (21 U.S.C. 360e)* : December 18, 2000. The applicant claims March 13, 2000, as the date the premarket approval application

(PMA)for GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM (PMA P000052) was initially submitted. However, FDA records indicate that PMA P000052 was completely submitted on December 18, 2000. 3. *The date the application was approved* : November 2, 2001. FDA has verified the applicant's claim that PMA P000052 was approved on November 2, 2001. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,062 days of patent term extension. Anyone with knowledge that any of the dates as published is incorrect may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments and ask for a redetermination by July 20, 2007. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by November 19, 2007. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: May 7, 2007. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E7-9720 Filed 5-18-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0195] Science Board to the Food and Drug Administration; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. *Name of Committee* : Science Board to the Food and Drug Administration (Science Board). *General Function of the Committee* : The Science Board provides advice primarily to the Commissioner of Food and Drugs and other appropriate officials on specific complex and technical issues as well as emerging issues within the scientific community in industry and academia. Additionally, the Science Board provides advice to the agency on keeping pace with technical and scientific evolutions in the fields of regulatory science, on formulating an appropriate research agenda, and on upgrading its scientific and research facilities to keep pace with these changes. It will also provide the means for critical review of agency sponsored intramural and extramural scientific research programs. *Date and Time* : The meeting will be held on June 14, 2007, from 8 a.m. to 4 p.m. *Addresses* : Electronic comments should be submitted to *http://www.fda.gov/dockets/ecomments* . Select Docket No. 2007N-0195—Science Board and follow prompts to submit your statement. Written comments should be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1066, Rockville, MD 20852, by close of business on June 7, 2007. All comments received will be posted without change, including any personal information provided. Comments received on or before June 7, 2007, will be provided to the committee before or at the meeting. *Location* : Holiday Inn Gaithersburg, Two Montgomery Village Ave., Gaithersburg, MD 20879, Grand Ballroom Conference Room. *Contact Person* : Carlos Peña, Office of the Commissioner, Food and Drug Administration (HF-33), 5600 Fishers Lane, Rockville, Maryland, 20857, 301-827-6687, *carlos.Peña@fda.hhs.gov* , or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512603. Please call the Information Line for up-to-date information on this meeting. A notice in the **Federal Register** about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency's Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. *Agenda* : The Science Board will hear about and discuss the agency's bioinformatics initiative and fellowship program. The Science Board will then continue their discussion of the review of both the agency's science programs and the National Antimicrobial Resistance Monitoring System (NARMS) Program, from the March 31, 2006, Science Board meeting. Discussions will first include a subcommittee update to the Science Board on the progress of the review of the agency's science programs. The Science Board will then hear about and discuss the subcommittee review of the NARMS Program including the public meeting regarding the NARMS Program on April 10, 2007, and subsequent deliberations. The Science Board will also hear about and discuss the agency's updates on drug safety, post approval surveillance, and food safety. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at *http://www.fda.gov/ohrms/dockets/ac/acmenu.htm* , click on the year 2007 and scroll down to the appropriate advisory committee link. *Procedure* : Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before May 31, 2007. Two oral presentations from the public will be scheduled between approximately 11 a.m. and 12 p.m. and 3:15 p.m. and 4:15 p.m. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before May 23, 2007. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing sessions. The contact person will notify interested persons regarding their request to speak by May 24, 2007. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Carlos Peña at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: May 15, 2007. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E7-9737 Filed 5-18-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004N-0226] Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 017 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled “Modifications to the List of Recognized Standards, Recognition List Number: 017” (Recognition List Number: 017), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. DATES: Submit written or electronic comments concerning this document at any time. See section VII of this document for the effective date of the recognition of standards announced in this document. ADDRESSES: Submit written requests for single copies of “Modifications to the List of Recognized Standards, Recognition List Number: 017” to the Division of Small Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Health (HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive labels to assist that office in processing your requests, or fax your request to 240-276-3151. Submit written comments concerning this document, or recommendations for additional standards for recognition, to the contact person (see FOR FURTHER INFORMATION CONTACT ). Submit electronic comments by e-mail: *standards@cdrh.fda.gov* . This document may also be accessed on FDA's Internet site at *http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/cdrhnew.cfm* . See section VI of this document for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 017 modifications and other standards related information. FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices and Radiological Health (HFZ-84), Food and Drug Administration, 2098 Gaither Road, Rockville, MD 20850, 240-276-0533. I. Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions or other requirements. In a notice published in the **Federal Register** of February 25, 1998 (63 FR 9561), FDA announced the availability of a guidance entitled “Guidance on the Recognition and Use of Consensus Standards.” The notice described how FDA would implement its standard recognition program and provided the initial list of recognized standards. Modifications to the initial list of recognized standards, as published in the **Federal Register** , are identified in table 1 of this document. **Table 1.** Federal Register Cite October 16, 1998 (63 FR 55617) July 12, 1999 (64 FR 37546) November 15, 2000 (65 FR 69022) May 7, 2001 (66 FR 23032) January 14, 2002 (67 FR 1774) October 2, 2002 (67 FR 61893) April 28, 2003 (68 FR 22391) March 8, 2004 (69 FR 10712) June 18, 2004 (69 FR 34176) October 4, 2004 (69 FR 59240) May 27, 2005 (70 FR 30756) November 8, 2005 (70 FR 67713) March 31, 2006 (71 FR 16313) June 23, 2006 (71 FR 36121) November 3, 2006 (71 FR 64718) These notices describe the addition, withdrawal, and revision of certain standards recognized by FDA. The agency maintains “hypertext markup language (HTML)” and “portable document format (PDF)” versions of the list of “FDA Recognized Consensus Standards.” Both versions are publicly accessible at the agency's Internet site. See section VI of this document for electronic access information. Interested persons should review the supplementary information sheet for the standard to understand fully the extent to which FDA recognizes the standard. II. Modifications to the List of Recognized Standards, Recognition List Number: 017 FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the agency will recognize for use in satisfying premarket reviews and other requirements for devices. FDA will incorporate these modifications in the list of FDA Recognized Consensus Standards in the agency's searchable database. FDA will use the term “Recognition List Number: 017 to identify these current modifications. In Table 2 of this document, FDA describes the following modifications:

(1)The withdrawal of standards and their replacement by others,

(2)the correction of errors made by FDA in listing previously recognized standards, and

(3)the changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of the standards. In section III of this document, FDA lists modifications the agency is making that involve the initial addition of standards not previously recognized by FDA. **Table 2.** Old Item No. Standard Change Replacement Item No. A. Anesthesia 19 ISO 8382:1988: Resuscitators Intended for Use With Humans Withdrawn 71 48 ASTM F1246-91(2005): Standard Specification for Electrically Powered Home Care Ventilators, Part 1—Positive-Pressure Ventilators and Ventilator Circuits Withdrawn and replaced with newer version 70 B. Biocompatibility 57 ASTM F895-84(2006): Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity Withdrawn and replaced with newer version 115 72 ASTM F1439-03: Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials Withdrawn and replaced with newer version 116 86 AAMI/ANSI/ISO 10993-10:2002(E): Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Sensitization Withdrawn—duplicate 87 87 AAMI/ANSI/ISO 10993-10:2002: Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Delayed-type Hypersensitivity Title 99 ASTM F1904-98(2003): Standard Practice for Testing the Biological Responses to Particles In Vivo Title C. Dental/Ear, Nose, and Throat

(ENT)60 ANSI/ADA Specification No. 96:2000: Dental Water-Based Cements Withdrawn and replaced with newer version 143 72 ISO 6877-2006: Dentistry—Root-canal Obturating Points Withdrawn and replaced with newer version 137 85 ANSI/ADA Specification No. 15:2000, Synthetic Polymer Teeth Withdrawn and replaced with newer version 138 91 ANSI/ADA Specification No. 80:2001, Dental Materials—Determination of Color Stability Title 114 ANSI/ADA Specification No. 48:2004, Visible Light Curing Units Withdrawn and replaced with newer version 139 D. General 2 IEC 60601-1, Medical Electrical Equipment—Part 1:General Requirements for Safety Contact Person 11 ISO 2859/1995, Sampling Procedures and Tables for Inspection By Attributes Contact Person 12 ISO 10012/1993, Quality Assurance Requirements for Measuring Equipment Part 1: Metrological Confirmation System for Measuring Equipment Contact Person 14 ANSI Z1.4/1993, Inspection by Attributes Contact Person 15 ANSI Z1.9/1993, Inspection by Variables Contact Person 18 ASTM D-4332/1991, Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing Contact Person 19 ASTM E-876/1995, Standard Practice for Use of Statistics in the Evaluation of Spectrometric Data Contact Person 20 ASTM F-1140/1988, Standard Test Method for Failure Resistance of Unrestrained and Nonrigid Packages for Medical Applications Contact Person 27 IEC 60601-1-1:2000, Medical Electrical Equipment—Part 1: General Requirement for Safety; Safety Requirements for Medical Electrical Systems Contact Person 28 IEC 60601-1-2, (Second Edition, 2001), Medical Electrical Equipment—Part 1-2: General Requirements for Safety; Electromagnetic Compatibility—Requirements and Tests Extent of Recognition 29 AAMI/ANSI HE74-2001, Human Factors Design Process for Medical Devices Contact Person 31 ISO 15223, Medical Devices—Symbols to be Used With Medical Device Labels, Labeling and Information to be Supplied Contact Person 32 EN 980:1996+1:1999+A2:2001, Graphical Symbols for use in the Labeling of Medical Devices Contact Person 35 AAMI/ANSI/IEC 60601-1-2, Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral standard: Electromagnetic Compatibility—Requirements and Tests (Edition 2:2001 with Amendment 1:2004) (AAMI/ANSI/IEC 60601-1--2:2001 is the U.S. version of IEC 60601-1-2:2001, with identical requirements for electromagnetic compatibility

(EMC)of medical electrical equipment.) Standard Organizations E. General Hospital/General Plastic Surgery 114 ISO 11608-1:2000 Pen-injectors for Medical Use—Part 1: Pen-injectors—Requirements and Test Methods Contact Person 115 ISO 11608-2:2000 Pen-injectors for Medical Use—Part 2: Needles—Requirements and Test Methods Contact Person 116 ISO 11608-3:2000 Pen-injectors for Medical Use—Part 3: Finished Cartridges—Requirements and Test Methods Contact Person 66 and 162 ISO 8536-1:2006 Infusion Equipment for Medical Use—Part 1: Infusion Glass Bottles Withdrawn and replaced with newer version 172 53 ASTM D5151-99

(2006)Standard Test Method for Detection of Holes in Medical Gloves Withdrawn and replaced with newer version 175 77 ASTM F1862-05 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) Withdrawn and replaced with newer version 181 80 ASTM E1112-00

(2006)Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature Withdrawn and replaced with newer version 177 84 ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves Withdrawn and replaced with newer version 178 161 ISO 10555-1:1995/ Amendment 1:1999, Amendment 2:2004 Sterile, Single-use Intravascular Catheters—Part 1: General Requirements Title 85 ASTM 5250-06 Standard Specification for Poly(vinyl chloride) Gloves for Medical Application Withdrawn and replaced with newer version 183 E. In Vitro Diagnostics 91 CLSI EP7-A2, Interference Testing in Clinical Chemistry; Approved Guidelines—Second Edition Withdrawn and replaced with newer version 127 F. Materials 1 ASTM F67-06: Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700) Withdrawn and replaced with newer version 129 2 ASTM F75-01: Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075) Contact Person 3 ASTM F90-01: Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605) Contact Person 10 ASTM F603-00: Standard Specification for High-Purity Dense Aluminum Oxide for Surgical Implant Application Contact Person 11 ASTM F620-06: Standard Specification for Alpha Plus Beta Titanium Alloy Forgings for Surgical Implants Withdrawn and replaced with newer version 130 15 ASTM F745-00: Standard Specification for 18 Chromium-12.5 Nickel-2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications Contact Person 26 ASTM F1314-01: Standard Specification for Wrought Nitrogen Strengthened 22 Chromium—13 Nickel—5 Manganese—2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910) Contact Person 27 ASTM F1341-99: Standard Specification for Unalloyed Titanium Wire UNS R50250, UNS R50400, UNS R50550, UNS R50700, for Surgical Implant Applications Withdrawn 30 ASTM F1537-00: Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloy for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539) Contact Person 32 ASTM F1586-02: Standard Specification for Wrought Nitrogen Strengthened 21 Chromium-10 Nickel-3 Manganese-2.5 Molybdenum Stainless Steel Bar for Surgical Implants (UNS S31675) Contact Person 37 ASTM F1813-01: Standard Specification for Wrought Titanium—12 Molybdenum—6 Zirconium—2 Iron Alloy for Surgical Implant (UNS R58120) Contact Person 41 ASTM F2066-01: Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150) Contact Person 43 ASTM F2146-01: Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320) Contact Person 44 ASTM F136-02a: Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) Contact Person 45 ASTM F562-02: Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035) Contact Person 46 ASTM F621-02: Standard Specification for Stainless Steel Forgings for Surgical Implants Contact Person 47 ASTM F799-06: Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539) Withdrawn and replaced with newer version 131 48 ASTM F899-02: Standard Specification for Stainless Steel for Surgical Instruments Contact Person 49 ASTM F1058-02: Standard Specification for Wrought 40Cobalt-20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire and Strip for Surgical Implant Applications (UNS R30003 and UNS R30008) Contact Person 50 ASTM F1091-02: Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy Surgical Fixation Wire (UNS R30605) Contact Person 52 ASTM F1350-02: Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673) Contact Person 53 ASTM F1472-02a: Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy for Surgical Implant Applications (UNS R56400) Contact Person 54 ASTM F1580-01: Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants Contact Person 56 ISO 5832-1:1997: Implants for Surgery—Metallic materials—Part 1: Wrought Stainless Steel Contact Person 57 ISO 5832-2:1999: Implants for Surgery—Metallic Materials—Part 2: Unalloyed Titanium Contact Person 58 ISO 5832-3:1996: Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminium 4-Vanadium Alloy Contact Person 59 ISO 5832-4:1996: Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum Casting Alloy Contact Person 61 ISO 5832-6:1997: Implants for Surgery—Metallic Materials—Part 6: Wrought Cobalt-nickel-chromium-Molybdenum alloy Contact Person 62 ISO 5832-9:1992: Implants for Surgery—Metallic Materials—Part 9: Wrought High Nitrogen Stainless Steel Contact Person 63 ISO 5832-11:1994: Implants for Surgery—Metallic Materials—Part 11: Wrought Titanium 6-aluminium 7 niobium Alloy Contact Person 64 ISO 5832-12:1996: Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum Alloy Contact Person 66 ISO 6474:1994: Implants for Surgery—Ceramic Materials Based on High Purity Alumina Contact Person 68 ISO 13782:1996: Implants for Surgery—Metallic Materials—Unalloyed Tantalum for Surgical Implant Applications Contact Person 76 ASTM F138-03: Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673) Contact Person 77 ASTM F139-03: Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673) Contact Person 79 ASTM F961-03: Standard Specification for Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Forgings for Surgical Implants [UNS R30035] Contact Person 80 ASTM F1088-04ae1: Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation Withdrawn and replaced with newer version 132 81 ASTM F1609-03: Standard Specification for Calcium Phosphate Coatings for Implantable Materials Contact Person 82 ASTM F1713-03: Standard Specification for Wrought Titanium-13 Niobium-13 Zirconium Alloy for Surgical Implant Applications Contact Person 85 ASTM F1854-01: Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants Contact Person 86 ASTM F1926-03: Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Coatings Contact Person 87 ASTM F1978-00e1: Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser Contact Person 88 ASTM F2024-00: Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings Contact Person 89 ASTM F1873-98: Standard Specification for High-Purity Dense Yttria Tetragonal Zirconium Oxide Polycrystal (Y-TZP) for Surgical Implant Applications Contact Person 94 ASTM F601-03: Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants Contact Person 95 ASTM F629-02: Standard Practice for Radiography of Cast Metallic Surgical Implants Contact Person 97 ASTM F2129-06: Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices Withdrawn and replaced with newer version 133 98 ASTM F451-99ae1: Standard Specification for Acrylic Bone Cement Contact Person 102 ASTM F2082-06: Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery Withdrawn and replaced with newer version 134 103 ASTM F1801-97(2004): Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials Contact Person and Type of Standard 104 ASTM F1108-04: Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406) Contact Person 106 ASTM F648-04: Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants Contact Person 107 ASTM F746-04: Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials Contact Person 108 ASTM F1295-05: Standard Specification for Wrought Titanium-6 Aluminum-7 Niobium Alloy for Surgical Implant Applications (UNS R56700) Contact Person 110 ASTM F1377-04: Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075) Contact Person 111 ASTM F1160-05: Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings Contact Person 112 ASTM F1044-05: Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings Contact Person 113 ASTM F1147-05: Standard Test Method for Tension Testing of Calcium Phosphate and Metal Coatings Contact Person 114 ASTM F2255-05: Standard Test Method for Strength Properties of Tissue Adhesives in Lap Shear by Tension Loading Contact Person 115 ASTM F2256-05: Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading Contact Person 116 ASTM F2258-05: Standard Test Method for Strength Properties of Tissue Adhesives in Tension Contact Person 117 ASTM F86-04: Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants Contact Person 119 ASTM F688-05: Standard Specification for Wrought Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035) Contact Person 120 ASTM F560-05: Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400) Contact Person 121 ASTM F2005-05: Standard Terminology for Nickel-Titanium Shape Memory Alloys Contact Person 122 ASTM F2063-05: Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants Contact Person 123 ISO 5832-5:2005: Implants for Surgery—Metallic Materials—Part 5: Wrought Cobalt-chromium-tungsten-nickel Alloy Contact Person 125 ASTM F2004-05: Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis Contact Person 126 ASTM F561-05a: Practice for Retrieval and Analysis of Implanted Medical Devices, and Associated Tissues Contact Person 127 ISO 5834-2:1998: Implants for Surgery—Ultra-High-Molecular-Weight Polyethylene—Part 2: Moulded Forms Contact Person G. OB-GYN/Gastroenterology 35 ASTM D6324-05 Standard Test Methods for Male Condoms Made from Synthetic Materials Withdrawn and replaced with newer version 41 H. Ophthalmic 3 ISO 9340:1996 Optics and Optical Instruments—Contact lenses—Determination of Strains for Rigid Contact Lenses Withdrawn 12 ISO 11980:1997 Ophthalmic Optics—Contact Lenses and Contact Lens Care Products—Guidance for Clinical Investigations Contact Person 13 ISO 10942:2006 Ophthalmic Instruments—Direct Ophthalmoscopes Withdrawn and replaced with newer version 37 15 ISO 9394:1998 Ophthalmic Optics—Contact Lenses and Contact Lens Care Products—Determination of Biocompatibility By Ocular Study Using Rabbit Eyes Contact Person 18 ISO 10943:2006 Ophthalmic Instruments—Indirect Ophthalmoscopes Withdrawn and replaced with newer version 38 20 ISO 11979-1:2006 Ophthalmic implants—Intraocular Lenses—Part 1: Vocabulary Withdrawn and replaced with newer version 40 23 ISO 11981:1999 Ophthalmic Optics—Contact Lenses And Contact Lens Care Products—Determination of Physical Compatibility of Contact Lens Care Products With Contact Lenses Contact Person 24 ISO 11986:1999 Ophthalmic Optics—Contact Lenses and Contact Lens Care Products—Guidelines for Determination of Preservative Uptake and Release Contact Person 34 ANSI Z80.20-2004 Ophthalmics—Contact Lenses—Standard Terminology, Tolerances, Measurements and Physicochemical Properties Contact Person I. Orthopedic/Physical Medicine 73 ISO 5838-1:1995: Implants for Surgery—Skeletal Pins and Wires—Part 1: Material and Mechanical Requirements Contact Person 74 ISO 5838-2:1991: Implants for Surgery—Skeletal Pins and Wires—Part 2: Steinmann Skeletal Pins—Dimensions Contact Person 75 ISO 5838-3:1993: Implants for Surgery—Skeletal Pins and Wires—Part 3: Kirschner Skeletal Wires Contact Person 79 ISO 7206-8:1995: Implants for Surgery—Partial and Total Hip Joint Prostheses—Part 8: Endurance Performance of Stemmed Femoral Components With Application of Torsion Contact Person 80 ISO 8828:1988: Implants for Surgery—Guidance on Care and Handling of Orthopaedic Implants Contact Person 81 ISO 9583:1993: Implants for Surgery—Non-destructive Testing—Liquid Penetrant Inspection of Metallic Surgical Implants Contact Person 82 ISO 9584:1993: Implants for Surgery—Non-destructive Testing—Radiographic Examination of Cast Metallic Surgical Implants Contact Person 83 ISO 13402:1995: Surgical and Dental Hand Instruments—Determination of Resistance Against Autoclaving, Corrosion and Thermal Exposure Contact Person 121 ISO 7207-1:1994: Implants for Surgery—Components for Partial and Total Knee Joint Prostheses—Part 1: Classification, Definitions and Designation of Dimensions Contact Person 155 ISO 7207-2:1998: Implants for Surgery—Components for Partial and Total Knee Joint Prostheses—Part 2: Articulating Surfaces Made of Metal, Ceramic and Plastics Materials Contact Person 163 ASTM F543-02e1, Standard Specification and Test Methods for Metallic Medical Bone Screws Withdrawn and replaced with newer version 202 166 ASTM F897-02: Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws Contact Person 167 ASTM F1089-02: Standard Test Method for Corrosion of Surgical Instruments Contact Person 168 ASTM F1781-03: Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants Contact Person 171 ASTM F1814-97a(2003): Standard Guide for Evaluating Modular Hip and Knee Joint Components Contact Person 172 ASTM F1798-97(2003): Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants Contact Person 175 ASTM F1582-98(2003): Standard Terminology Relating to Spinal Implants Contact Person 177 ASTM F1264-03: Standard Specification and Test Methods for Intramedullary Fixation Devices Contact Person 178 ASTM F1440-92(2002): Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components Without Torsion Contact Person 179 ASTM F2068-03: Standard Specification for Femoral Prostheses—Metallic Implants Contact Person 180 ASTM F366-04: Standard Specification for Fixation Pins and Wires Contact Person 181 ASTM F1717-04: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model Contact Person 182 ASTM F1800-04: Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements Contact Person 183 ASTM F1875-98(2004): Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-bore and Cone Taper Interface Contact Person 185 ASTM F2267-04: Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression Contact Person 186 ASTM F2077-03: Test Methods for Intervertebral Body Fusion Devices Contact Person 187 ASTM F2193-02: Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System Contact Person 188 ISO 14243-1:2002: Implants for Surgery—Wear of Total Knee-joint Prostheses—Part 1: Loading and Displacement Parameters for Wear-testing Machines with Load Control and Corresponding Environmental Conditions for Test Contact Person 189 ISO 14243-2:2000: Implants for Surgery—Wear of Total Knee-joint Prostheses—Part 2: Methods of Measurement Contact Person 190 ISO 14243-3:2004: Implants for Surgery—Wear of Total Knee-joint Prostheses—Part 3: Loading and Displacement Parameters for Wear-Testing Machines with Displacement Control and Corresponding Environmental Conditions for Test Contact Person 191 ISO 14879-1:2000: Implants for Surgery—Total Knee-joint Prostheses—Part 1: Determination of Endurance Properties of Knee Tibial Trays Contact Person 192 ASTM F1223-05: Standard Test Method for Determination of Total Knee Replacement Constraint Contact Person J. Radiology 34 IEC 60601-2-7

(1998)Medical Electrical Equipment—Part 2-7: Particular Requirements for the Safety of High-Voltage Generators of Diagnostic X-ray Generators Contact Person 68 NEMA MS 4-2006 Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices Withdrawn and replaced with newer version 151 101 ANSI / IESNA RP-27.1-05 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems—General Requirements Withdrawn and replaced with newer version 153 104 IEC 60601-2-33 (2006), Medical Electrical Equipment—Part 2-33: Particular Requirements for the Safety of Magnetic Resonance Equipment for Medical Diagnosis Withdrawn and replaced with newer version 161 111 ISO 11554:2006 Optics and Photonics—Lasers and Laser-Related equipment—Test Methods for Laser Beam Power, Energy and Temporal Characteristics Withdrawn and replaced with newer version 155 K. Software 1 ISO/IEC 12207:1995 Information Technology—Software Life Cycle Processes Withdrawn 3 IEEE/EIA 12207.0-1996 Industry Implementation of International Standard ISO/IEC 12207:1995(ISO/IEC 12207) Standard for Information Technology—Software Life Cycle Processes Withdrawn 5 IEEE 1074-1997 Standard for Developing a Software Project Life Cycle Process Withdrawn 6 IEEE 1012-2004 Standard for Software Verification and Validation Withdrawn 7 AAMI / ANSI SW68:2001 Medical Device Software—Software Life Cycle Processes Withdrawn L. Sterility 67 ASTM F1140-2005, Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages for Medical Applications Withdrawn and replaced with newer version 196 68 ASTM F1585:2000, Standard Guide for Integrity Testing of Porous Barrier Medical Packages Withdrawn 69 ASTM F1608:2004, Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method Withdrawn and replaced with newer version 197 89 ASTM F2054-05, Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates Withdrawn and replaced with newer version 198 121 ASTM D4169-05, Standard Practice for Performance Testing of Shipping Containers and Systems Withdrawn and replaced with newer version 199 122 ASTM F88-2006, Standard Test Method for Seal Strength of Flexible Barrier Materials Withdrawn and replaced with newer version 200 M. Tissue Engineering 1 ASTM F2064-00(2006): Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for use in Biomedical and Tissue-Engineered Medical Products Application Withdrawn and replaced with newer version 8 III. Listing of New Entries In table 3 of this document, FDA provides the listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 017. **Table 3.** Item No. Title of Standard Reference No. & Date A. Anesthesia 71 Lung Ventilators for Medical use—Particular Requirements for Basic Safety and Essential Performance—Part 5: Gas-powered Emergency Resuscitators ISO 10651-5:2006 B. Cardiovascular/Neurology 59 Implants for surgery—Cardiac Pacemakers—Part 3: Low-profile Connectors (IS-1) for Implantable Pacemakers ISO 5841-3:2000 C. Dental/ENT 140 Dental Base Metal Casting Alloys—Part 2: Nickel-based Alloys ISO 6871-2:1994/Amd 1:2005 141 Dental Base Metal Casting Alloys—Part 1: Cobalt-based Alloys ISO 6871-1:1994 142 Dental Base Metal Casting Alloys—Part 1: Cobalt-based Alloys ISO 6871-1:1994/Amd 1:2005 D. General 36 Technical Information Report: Medical Devices—Guidance on the Selection of Standards in Support of Recognized Essential Principles of Safety and Performance of Medical Devices, Second Edition ANSI/AAMI/ISO TIR 16142:2006 E. General Hospital/General Plastic Surgery 170 Sterile hypodermic syringes for single use—Part 1: Syringes for Manual Use ISO 7886-1:1993/ Corrigendum 1:1995 171 Sterile, Single-use Intravascular Catheters- Part 3: Central Venous Catheters ISO 10555-3:1996/ Corrigendum 1:2002 173 Infusion Equipment for Medical Use—Part 2: Closures for Infusion Bottles ISO 8536-2:2001/ Corrigendum 1:2003 174 Pen-injectors for Medical Use—Part 4: Requirements and Test Methods for Electronic and Electromechanical Pen-injectors ISO 11608-4:2006 176 Standard Guide for Assessment of Medical Gloves ASTM D7103-06 179 Needle-free Injectors for Medical Use—Requirements and Test Methods ISO 21649:2006 180 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities ASTM F2407-06 182 Medical Electrical Equipment— Part 2-38: Particular Requirements for the Safety of Electrically Operated Hospital Beds IEC 60601-2-38 1996/Amendment 1:1999 F. In Vitro Diagnostic 128 Evaluation of Matrix Effects; Approved Guideline—Second Edition CLSI EP14-A2 2005 129 Quality Control of Microbiological Transport Systems CLSI M40-A 2003 G. Materials 135 Standard Test Method for Burst Strength of Surgical Sealants ASTM F2392-04 136 Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants ASTM F2458-05 H. OB-GYN/Gastroenterology 42 Medical electrical equipment—Part 2: Particular Requirements for the Safety of Endoscopic Equipment IEC 60601-2-18

(1996)Amendment 1 2000 43 Rubber Condoms—Guidance on the Use of ISO 4074 in the Quality Management of Natural Rubber Latex Condoms ISO 16038:2005 I. Ophthalmic 43 Ophthalmic Implants—Intraocular lenses—Part 8: Fundamental Requirements ISO 11979-8:2006 J. Radiology 150 Information Technology—Digital Compression and Coding of Continuous-tone Still Images—Part 1: Requirements and Guidelines IEC / ISO 10918-1:1994 Technical Corrigendum 1:2005 152 Medical Electrical Equipment—Part 2-1: Particular Requirements for the Safety of Electron Accelerators in the Range 1 MeV to 50 MeV IEC 60601-2-1 (1998-06), Amendment 1 2002 154 Lasers and Laser-related Equipment—Determination of Laser-induced Damage Threshold of Optical Surfaces—Part 3: Assurance of Laser Power (energy) Handling Capabilities ISO 11254-3:2006 156 Lasers and Laser-related Equipment—Test Methods for Laser Beam Parameters—Beam Positional Stability ISO 11670:2003 Technical Corrigendum 1:2004 157 Optics and Optical Instruments—Lasers and Laser-related Equipment—Test Methods for Laser Beam Power (energy) Density Distribution ISO 13694:2000 Technical Corrigendum 1:2005 158 Determination of Local Specific Absorption Rate

(SAR)in Diagnostic Magnetic Resonance Imaging NEMA MS 10-2006 159 Determination of Gradient-Induced Electric Fields In Diagnostic Magnetic Resonance Imaging NEMA MS 11-2006 160 Quantification and Mapping of Geometric Distortion for Special Applications NEMA MS 12-2006 IV. List of Recognized Standards FDA maintains the agency's current list of FDA recognized consensus standards in a searchable database that may be accessed directly at FDA's Internet site at *http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm* . FDA will incorporate the modifications and minor revisions described in this notice into the database and, upon publication in the **Federal Register** , this recognition of consensus standards will be effective. FDA will announce additional modifications and minor revisions to the list of recognized consensus standards, as needed, in the **Federal Register** once a year, or more often, if necessary. V. Recommendation of Standards for Recognition by FDA Any person may recommend consensus standards as candidates for recognition under the new provision of section 514 of the act by submitting such recommendations, with reasons for the recommendation, to the contact person (See FOR FURTHER INFORMATION CONTACT ). To be properly considered, such recommendations should contain, at a minimum, the following information:

(1)Title of the standard,

(2)any reference number and date,

(3)name and address of the national or international standards development organization,

(4)a proposed list of devices for which a declaration of conformity to this standard should routinely apply, and

(5)a brief identification of the testing or performance or other characteristics of the device(s) that would be addressed by a declaration of conformity. VI. Electronic Access You may obtain a copy of “Guidance on the Recognition and Use of Consensus Standards” by using the Internet. CDRH maintains a site on the Internet for easy access to information including text, graphics, and files that you may download to a personal computer with access to the Internet. Updated on a regular basis, the CDRH home page includes the guidance as well as the current list of recognized standards and other standards related documents. After publication in the **Federal Register** , this notice announcing “Modifications to the List of Recognized Standards, Recognition List Number: 017” will be available on the CDRH home page. You may access the CDRH home page at *http://www.fda.gov/cdrh* . You may access “Guidance on the Recognition and Use of Consensus Standards,” and the searchable database for “FDA Recognized Consensus Standards” through the hyperlink at *http://www.fda.gov/cdrh/stdsprog.html* . This **Federal Register** document on modifications in FDA's recognition of consensus standards is available at *http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/cdrhnew.cfm* . VII. Submission of Comments and Effective Date Interested persons may submit to the contact person (see FOR FURTHER INFORMATION CONTACT ) written or electronic comments regarding this document. Two copies of any mailed comments are to be submitted, 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. FDA will consider any comments received in determining whether to amend the current listing of modifications to the list of recognized standards, Recognition List Number: 017. These modifications to the list or recognized standards are effective upon publication of this notice in the **Federal Register** . Dated: May 10, 2007. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E7-9718 Filed 5-18-07; 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. A Method With Increased Yield for Production of Polysaccharide-Protein Conjugate Vaccines Using Hydrazide Chemistry *Description of Technology:* Current methods for synthesis and manufacturing of polysaccharide-protein conjugate vaccines employ conjugation reactions with low efficiency (about twenty percent). This means that up to eighty percent of the added activated polysaccharide

(PS)is lost. In addition, inclusion of a chromatographic process for purification of the conjugates from unconjugated PS is required. The present invention utilizes the characteristic chemical property of hydrazide groups on one reactant to react with aldehyde groups or cyanate esters on the other reactant with an improved conjugate yield of at least sixty percent. With this conjugation efficiency the leftover unconjugated protein and polysaccharide would not need to be removed and thus the purification process of the conjugate product can be limited to diafiltration to remove the by-products of small molecules. The new conjugation reaction can be carried out within one or two days with reactant concentrations between 1 and 25 mg/mL at PS/protein ratios from 1:2 to 3:1, at temperatures between 4 and 40 degrees Centigrade, and in a pH range of 5.5 to 7.4, optimal conditions varying from PS to PS. *Application:* Cost effective and efficient manufacturing of conjugate vaccines. *Inventors:* Che-Hung Robert Lee and Carl E. Frasch (CBER/FDA). *Patent Status:* U.S. Patent Application No. 10/566,899 filed 01 Feb 2006, claiming priority to 06 Aug 2003 (HHS Reference No. E-301-2003/0-US-10); U.S. Patent Application No. 10/566,898 filed 01 Feb 2006, claiming priority to 06 Aug 2003 (HHS Reference No. E-301-2003/1-US-02); International rights available. *Licensing Status:* Available for non-exclusive licensing. *Licensing Contact:* Peter A. Soukas, J.D.; 301/435-4646; *soukasp@mail.nih.gov* . A Method of Immunizing Humans Against Salmonella Typhi Using a Vi-rEPA Conjugate Vaccine *Description of Technology:* This invention is a method of immunization against typhoid fever using a conjugate vaccine comprising the capsular polysaccharide of *Salmonella typhi* , Vi, conjugated through an adipic dihydrazide linker to nontoxic recombinant exoprotein A

(rEPA)from *Pseudomonas aeruginosa* . The three licensed vaccines against typhoid fever, attenuated *S. typhi* Ty21a, killed whole cell vaccines and Vi polysaccharide, have limited efficacy, in particular for children under 5 years of age, which make an improved vaccine desirable. It is generally recognized that an effective vaccine against *Salmonella typhi* is one that increases serum anti-Vi IgG eight-fold six weeks after immunization. The conjugate vaccine of the invention increases anti-Vi IgG, 48-fold, 252-fold and 400-fold in adults, in 5-14 years-old and 2-4 years-old children, respectively. Thus this is a highly effective vaccine suitable for children and should find utility in endemic regions and as a traveler's vaccine. The route of administration can also be combined with routine immunization. In 2-5 years old, the protection against typhoid fever is 90% for 4 years. In school age children and in adults the protection could mount to completer protection according to the immunogenicity data. *Application:* Immunization against *Salmonella typhi* for long term prevention of typhoid fever in all ages. *Developmental Status:* Conjugates have been synthesized and clinical studies have been performed. The synthesis of the conjugates is described by Kossaczka et al. in Infect Immun. 1997 June;65(7):2088-2093. Phase III clinical studies are described by Mai et al. in N Engl J Med. 2003 October 2; 349(14):1390-1391. Dosage studies are described by Canh et al. in Infect Immun. 2004 Nov;72(11):6586-6588. A safety and immunogenicity study in infants are underway. The aim is to administer the conjugate vaccine with routine infant immunization. Preliminary results show the vaccine is safe in 2 months old infants. *Inventors:* Zuzana Kossaczka, Shousun C. Szu, and John B. Robbins (NICHD). *Patent Status:* U.S. Patent 6,797,275 issued 28 Sep 2004 (HHS Reference No. E-020-1999/0-US-02); U.S. Patent Application No. 10/866,343 filed 10 Jun 2004 (HHS Reference No. E-020-1999/0-US-03); U.S. Patent Application No. 11/726,304 filed 20 Mar 2007 (HHS Reference No. E-020-1999/0-US-04). *Licensing Status:* Available for non-exclusive licensing. *Licensing Contact:* Peter A. Soukas, J.D.; 301/435-4646; *soukasp@mail.nih.gov* . *Collaborative Research Opportunity:* The National Institute of Child Health and Human Development, Laboratory of Developmental and Molecular Immunity, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize A Method of Immunizing Humans Against Salmonella Typhi Using a Vi-rEPA Conjugate Vaccine. Please contact John D. Hewes, Ph.D., at 301-435-3121 or *hewesj@mail.nih.gov* for more information. Vaccine Against Escherichia Coli 0157 Infection, Composed of Detoxified LPS Conjugated to Proteins *Description of Technology:* This invention is a conjugate vaccine to prevent infection by *E. coli* 0157:H7, particularly in young children under 5 years of age. *E. coli* 0157:H7 is an emerging human pathogen which causes a spectrum of illnesses with high morbidity and mortality, ranging from diarrhea to hemorrhagic colitis and hemolytic-uremic syndrome (HUS). Infection with *E. coli* 0157:H7 occurs as a result of consumption of water, vegetables, fruits or meat contaminated by feces from infected animals, such as cattle. The most recent large outbreak in the U.S. was from contaminated bag spinach. The conjugate is composed of the O-specific polysaccharide isolated from *E. coli* 0157, or other Shiga-toxin producing bacteria, conjugated to carrier proteins, such as non-toxic *P. aeruginosa* exotoxin A or Shiga toxin 1. A Phase I clinical trial, involving adult humans, showed the vaccine is safe and highly immunogenic. Adults, after one injection containing 25 *μ* g of antigen, responded with high titers of bactericidal antibodies. Similarly in a phase II study, fifty 2-to-5- years old children in U.S. were injected with the conjugate vaccines. There were only mild local adverse reactions. More than 90% of the children responded with greater than 10 fold rise of *E. coli* O157 antibodies of bactericidal ability. Thus the conjugates of the invention are promising vaccines, especially for children and the elderly, who are most likely to suffer serious consequences from infection. *Application:* Prevention of *E. coli* O157 infection. *Development Status:* Clinical studies have been performed and are described in Konadu *et al.,* J Infect Dis. 1998 Feb; 177(2):383-387 and Ahmed *et al.* , J Infect Dis. 2006 Feb; 193(2):515-526. *Inventors:* Shousun C. Szu, Edward Konadu, and John B. Robbins (NICHD). *Patent Status:* U.S. Patent 6,858,211 issued 22 Feb 2005 (HHS Reference No. E-158-1998/0-US-06); U.S. Patent Application No. 10/987,428 filed 12 Nov 2004 (HHS Reference No. E-158-1998/0-US-07); U.S. Patent Application No. 11/015,436 filed 16 Dec 2004 (HHS Reference No. E-158-1998/0-US-08). *Licensing Status:* Available for non-exclusive or exclusive licensing. *Licensing Contact:* Peter A. Soukas, J.D.; 301/435-4646; *soukasp@mail.nih.gov* . *Collaborative Research Opportunity:* The National Institute of Child Health and Human Development, Laboratory of Developmental and Molecular Immunity, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize Vaccine for *E. coli* O157 for Children and Adults. Please contact John D. Hewes, Ph.D., at 301-435-3121 or *hewesj@mail.nih.gov* for more information. Dated: May 11, 2007. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E7-9656 Filed 5-18-07; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN National Institutes of Health National Cancer Institute; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Cancer Advisory Board, June 14, 2007, 2 p.m. to June 15, 2007, 12 p.m., National Institutes of Health, Building 31, 31 Center Drive, Bethesda, MD 20892, which was published in the **Federal Register** on May 2, 2007, 72 FR 24319. The notice is being amended to change the open session start and end times on June 14, 2007 to 1:15 p.m.—4:20 p.m. and the end time on June 15, 2007 to 11:45 a.m. The meeting is partially Closed to the public. Dated: May 14, 2007. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 07-2495 Filed 5-18-07; 8:45 am]

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