Notices. Notice

10,638 words·~48 min read·/register/2007/08/03/07-3775

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

BILLING CODE 4160-90-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food Safety and Security Monitoring Project—Radiological Health; Availability of Cooperative Agreements Under a Limited Competition; Request for Applications: FD07-005; Catalog of Federal Domestic Assistance Number: 93.448 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. I. Funding Opportunity Description The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Division of Federal-State Relations, is announcing the availability of cooperative agreements for equipment, supplies, personnel, training, and facility upgrades to Food Emergency Response Laboratory Network

(FERN)radiological laboratories of State, local, and tribal governments. The cooperative agreements are to enable the analyses of foods and food products in the event that redundancy and/or additional laboratory surge capacity is needed by FERN for analyses related to radiological terrorism or other emergency situations. These cooperative agreements are also intended to expand participation in networks to enhance Federal, State, local, and tribal governmental food safety and security efforts. This notice supersedes the request for applications that published in the **Federal Register** of August 24, 2006 (71 FR 50068). A. Background ORA is the primary inspection and analysis component of FDA and has approximately 1,600 investigators, inspectors, and analysts who cover the country's approximately 95,000 FDA-regulated businesses. These investigators inspect more than 15,000 facilities per year and ORA laboratories analyze several thousand samples per year. ORA conducts special investigations, conducts food inspection recall audits, performs consumer complaint inspections, and collects samples of regulated products. Increasingly, ORA has been called upon to expand the testing program that addresses the increasing threat to food safety and security through intentional radiological terrorism events. Toward this end, ORA has developed radiological screening and analysis methodologies that are used to evaluate foods and food products in such situations. However, in the event of a large-scale emergent incident, analytical sample capacity in ORA field laboratories has a finite limit. Information from ongoing relationships with State partners indicates limited redundancy in State food testing laboratories; both in terms of analytical capabilities and analytical sample capacity. Several State food testing laboratories lack the specialized equipment to perform the analyses, and/or the specific methodological expertise in the types of analyses performed for screening foods and food products involving radiological terrorism events. The events of September 11, 2001, reinforced the need to enhance the security of the U.S. food supply. Congress responded by passing the Bioterrorism Act, which President George W. Bush signed into law on June 12, 2002. The Bioterrorism Act is divided into the following five titles: Title I—National Preparedness for Bioterrorism and Other Public Health Emergencies, Title II—Enhancing Controls on Dangerous Biological Agents and Toxins, Title III—Protecting Safety and Security of Food and Drug Supply, Title IV—Drinking Water Security and Safety, and Title V—Additional Provisions. Subtitle A of the Bioterrorism Act, “Protection of Food Supply,” section 312, “Surveillance and Information Grants and Authorities,” amends part B of Title III of the Public Health Service Act to authorize the Secretary of Health and Human Services to award grants to States and Indian tribes to expand participation in networks to enhance Federal, State, and local food safety efforts. This may include meeting the costs of establishing and maintaining the food safety surveillance, technical, and laboratory capacity needed for such participation. FDA will support the projects covered by this document under the authority of section 312 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Public Law 107-188). This program is described in the Catalog of Federal Domestic Assistance under number 93.448. B. Program Research Goals The goal of ORA's cooperative agreement program is to complement, develop, and improve State, local, and Indian tribal food safety and security testing programs. This will be accomplished through the provision of equipment, supplies, personnel, facility upgrades, training in current food testing methodologies, participation in proficiency testing to establish additional reliable laboratory sample analysis capacity, analysis of surveillance samples, and, in cooperation with FDA, participation in method enhancement activities designed to extend analytical capabilities. In the event of a large-scale radiological terrorism event affecting foods or food products, the recipient may be required to perform selected radiological analyses of domestic and imported food samples collected and supplied to the laboratory by FDA or other Federal agencies through FDA. These samples may consist of, but are not limited to, the following: Vegetables and fruits (fresh and packaged), juices (concentrate and diluted), grains and grain products, seafood and other fish products, milk and other dairy products, infant formula, baby foods, bottled water, condiments, and alcoholic products (beer, wine, scotch). All grant application projects that are developed at State, local, and tribal governmental levels must have national implication or application that can enhance Federal food safety and security programs. At the discretion of FDA, successful project formats will be made available to interested Federal, State, local, and tribal government FERN laboratories. There are two key project areas identified for this effort: 1. The use of gamma spectrometry analysis for the screening and identification of gamma-emitting radionuclides in foods, and 2. The use of beta spectrometry analysis for the screening and identification of beta-emitting radionuclides in foods. It should be emphasized that in all of the projects, there is a particular desire to promote a continuing, reliable capability and capacity for laboratory sample analyses of foods and food products for the rapid detection and identification of radionuclides. With this in mind, it is desirable that sample analyses will be completed within 2 weeks of receipt, and the results will be reported to FERN. The format and reporting media will be established by FERN. Shorter timeframes may be sought for special testing such as proficiency tests or special assignments. II. Award Information Support will be in the form of cooperative agreements. Substantive involvement by the awarding agency is inherent in the cooperative agreement awards. Accordingly, FDA will have substantial involvement in the program activities of the project funded by the cooperative agreement. Substantive involvement includes, but is not limited to, the following:

(1)How often samples will be sent,

(2)directions on how tests should be executed,

(3)onsite monitoring,

(4)supply of equipment,

(5)FDA training on processes, and

(6)enhancement and extension of analytical methodology. FDA will provide specific procedures and protocols for the two project areas (see section I of this document) to be used for the analysis of collected food samples. FDA will provide guidance on the specific foods to be collected and analyzed by the successful applicant. State personnel will be responsible for the collection and analysis of surveillance samples. Proposed projects designed to fulfill the specific objectives of any one or more of the project areas will be considered for funding. Applicants may also apply for facility upgrades, personnel, training, and surveillance sample collection. A. Award Amount The total amount of funding available in fiscal year 2007 is $750,000. Cooperative agreements will be awarded up to $250,000 in total (direct plus indirect) costs per year for up to 3 years. It is anticipated that 3 awards will be made. Support of these cooperative agreements will be for the funding of supplies, facility upgrades, surveillance sample collection, personnel, the provision of training in current analytical methodology, and for the analysis of foods and food products. Funds may be requested in the budget to travel to FDA for meetings with program staff about the progress of the project and to travel for training. If the applicant does not have the necessary equipment available for these projects, all major needed equipment will be provided on loan from FDA and will not be included in the award amount. B. Length of Support The length of support is 3 years and all applicants must apply for the full 3 years of currently projected funding and program objectives. The initial competitive review and award process will provide all awardees with 1 year of funding. The second and third year of funding of noncompetitive continuation of support will based on performance during the preceding year and availability of Federal funds. C. Equipment FDA will purchase and have all needed major equipment for the two project areas delivered to the awardee's laboratory. The equipment purchased by FDA will remain the property of FDA under loan to the awardee's laboratory for a minimum of 5 years at which point in time it may or may not be released as surplus property. FDA may terminate the loan at any time. The equipment may not be transferred by the awardee's laboratory to a third party, and the awardee's laboratory assumes full responsibility and liability for any claims that may arise as a result of operation of this equipment for the period it is in the possession of the awardee's laboratory. D. Funding Plan It is anticipated that FDA will make three awards in fiscal year 2007 for this program. The number of projects funded will depend on the quality of the applications received and is subject to availability of Federal funds to support the projects. III. Eligibility Information A. Eligible Applicants Due to the sensitive counterterrorism nature of this project it is imperative that only State government entities with the regulatory authority to conduct onsite inspections be participatory members of this cooperative agreement program. This is to ensure that any regulatory action and/or laboratory analysis that must be completed in an emergent situation can be carried out in the most expeditious manner. Therefore, this cooperative agreement program is available only to current FERN radiological laboratories at the time of the submission of this application also fall into one of the following categories: State laboratories, State regulatory agencies with the required lab capacity and university laboratories that are currently State adjunct laboratories connected to State laboratory and/or regulatory agencies with the required State regulatory authority. B. Cost Sharing or Matching Cost sharing is not required. C. Other The entity and/or any or all person(s) involved in any aspect of the design, implementation, and/or evaluation of a successful Food Safety and Security Monitoring Project—Radiological Health cooperative program application may at any time at FDA's discretion be subject to requirements under 42 CFR parts 72 and 73 (70 FR 13294, March 18, 2005), the Bioterrorism Act, and the USA Patriot Act, including but not limited to security risk assessments and security clearances. *Dun & Bradstreet Number (DUNS)* : As of October 1, 2003, applicants are required to have a DUNS number to apply for a grant or cooperative agreement from the Federal Government. The DUNS number is a 9-digit identification number that uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, call 1-866-705-5711. Be certain that you identify yourself as a Federal grant applicant when you contact Dun & Bradstreet, Inc. IV. Application and Submission A. Addresses to Request Application FDA is only accepting applications for this program electronically via Grants.gov by visiting the Web site *http://www.grants.gov* 1 and following the instructions under “APPLY.” In order to apply electronically, the applicant must have a DUNS number (see section III.C of this document) and register in the Central Contractor Registration

(CCR)database as described in section IV.F of this document. 1 (FDA has verified the Web site address, but FDA is not responsible for subsequent changes to the Web site after this document publishes in the **Federal Register** .) The required application, SF424 can be completed and submitted online. We strongly encourage using the “Tips” posted on *http://www.grants.gov* 1 under the announcement number when preparing your submission. If you experience technical difficulties with your online submission you should contact either the Grants.gov Customer Response Center at *http://www.grants.gov/contactus/contactus.jsp* 1 or Michelle Caraffa, Food and Drug Administration, 301-827-7025, e-mail: *michelle.caraffa@fda.hhs.gov* . To comply with the President's Management Agenda, the Department of Health and Human Services

(HHS)is participating as a partner in the new governmentwide Grants.gov application site. Users of Grants.gov will be able to download a copy of the application package, complete it offline, and then upload and submit the application via the Grants.gov Web site. When you enter the Grants.gov Web site, you will find information about submitting an application electronically through the Web site. In addition, this process is similar to the R01 Grant Application process currently used at the National Institutes of Health. You can visit the following Web site for helpful background on preparing to apply, preparing an application, and submitting an application to Grants.gov: *http://era.nih.gov/ElectronicReceipt/* . 1 In unusual circumstances, additional information may be considered, on a case-by-case basis, for inclusion in the ad hoc expert panel review (see section V.A.2 of this document), however, FDA cannot assure inclusion of any information after the receipt date, other than evidence of final Institutional Review Board

(IRB)approval, Federal-Wide Assurance (FWA), and certification of adequate supply of study product. If an application for the same grant was submitted in response to a previous request for applications but has not yet been funded, an application in response to this document will be considered a request to withdraw the previous application. The applicant for a resubmitted application should address the issues presented in the summary statement from the previous review and include a copy of the summary statement itself as part of the resubmitted application. The submitted electronic application package is posted under the “APPLY” section for this announcement at *http://www.grants.gov* . 1 The required application SF424, which is part of the PHS 5161-1 form, should be completed and submitted online. B. Content and Form of Application 1. Content of Application The ad hoc expert panel will review the application based on the following criteria that each applicant should address in their cooperative agreement application: a. *The rationale and design to meet the goals of the cooperative agreement* . A full description of the prospective project's intended goals and objectives and how each will guide a full project plan. This section should lay a foundation for the entire program. b. *Expertise in the use of gamma or beta spectroscopy in the analysis of foods or animal tissues* . Specifically address and provide the qualifications of all personnel that will be assigned to the project. Curriculum vitae/resumes for key laboratory personnel, including information on personnel that have experience in gamma and beta spectroscopy, must be provided. c. *Sample analysis commitment* . The variety and number of samples analyzed in the current food or animal tissue programs. The laboratory will be required to analyze surveillance and emergency response food samples. Therefore, an estimate of the number of food samples that can be analyzed for radionuclides by each project area (i.e., gamma spectroscopy, beta spectroscopy), must be submitted. This estimate should be for a 3-year period. The estimate should also address the number of samples that can be analyzed in a 2-week period. The procedures to be used will be supplied by FDA. This information will be provided after the award is given, so recipients will be aware of requirements/responsibilities. In addition, if a cooperative agreement is awarded, awardees will be informed of any additional documentation that should be submitted to FERN. d. *The adequacy of facilities, support services, and quality control and quality assurance procedures and practices for food and animal tissue analysis* . This section should include: • A summary description of procedures in place to monitor sample workflow, including the tracking and monitoring of sample analyses and a description of the current quality assurance program. • A discussion of the laboratory's ability to complete and report on a given sample analysis within the required 2-week time frame. • The name and address of the laboratory facility where the equipment will be installed and the name of the responsible individual at the facility. • A complete description of the laboratory facility, specifically addressing the following information: ◦ Floor diagrams of the current laboratory; ◦ A description of the envisaged space, to include a floor-plan diagram; ◦ Area where the equipment is to be installed. The installation of equipment in a laboratory will require adequate and appropriate space and physical plant supplies, such as power, water, etc.; ◦ A detailed description of the proposed facilities upgrade including drawings and cost estimates; ◦ Operational support areas to be used for the project, including details about the availability of ancillary laboratory safety and support equipment and facilities, such as the numbers and types of chemical fume hoods available; ◦ Details describing the sample receiving and sample storage areas and a description of any existing chain-of-custody procedures; ◦ A detailed description of laboratory access procedures, including a description of practices and systems which limit access to laboratory space by unauthorized personnel. Additional procedures for access to the space(s) dedicated to the equipment provided, if any, should also be included. e. *Laboratory management practices* . Abilities and procedures in place to recall personnel and establish extended work weeks and commitment to analyze emergency response samples. For the laboratory, the following management information must be provided: • A summary description of any quality management system defined, in development, or in place as it relates to quality control and quality assurance procedures and practices; • A summary description of staffing management, specifically to include abilities and procedures in place to recall personnel, establish extended work weeks, etc.; and • A summary description of any security procedures or processes to evaluate the background of laboratory personnel. This should include any procedures to evaluate subcontractors who have access to laboratory space, such as cleaning personnel. 2. Format for Application All applications must be submitted electronically through Grants.gov. Paper applications will not be accepted. The application must be an SF424. The title of the proposed grant must include the name of the product and the investigational drug (IND)/investigational device exemption

(IDE)number. The narrative portion, excluding appendices, of the application may not exceed 100 pages in length and must be single-spaced in 12-point font. The appendices should also not exceed 100 pages in length (separate from the narrative portion of the application). Data and information included in the application will generally not be available publicly prior to the funding of the application. After funding has been awarded, data and information included in the application will be given confidential treatment to the extent permitted by the Freedom of Information Act (5 U.S.C. 552(b)(4)) and FDA's implementing regulations (including 21 CFR 20.61, 20.105, and 20.106). By accepting funding, the applicant agrees to allow ORA to publish specific information about the grant. The requirements requested on form PHS 5161-1 (revised 7/00) have been sent by PHS to the Office of Management and Budget

(OMB)and have been approved and assigned OMB control number 0248-0043. C. Submission Dates and Times The application receipt date is August 24, 2007. Applications must be received by the close of business on the established receipt date. Applications not received on time will not be considered for review and will generally be returned to the applicant. However, late applications may be accepted under extreme circumstances beyond the control of the applicant. No addendum material will be accepted after the receipt date. D. Intergovernmental Review The regulations issued under Executive Order 12372, Intergovernmental Review of Department of Health and Human Services Programs and Activities (45 CFR part 100) apply to the Food Safety and Security Monitoring Project. Applicants (other than federally recognized Indian tribal governments) should contact the State's Single Point of Contact

(SPOC)as early as possible to alert the SPOC to the prospective application(s) and to receive any necessary instructions on the State's review process. A current listing of SPOCs is included in the application kit or at *http://www.whitehouse.gov/omb/grants/spoc.html* . 1 The SPOC should send any State review process recommendations to the FDA administrative contact (see section VII of this document). The due date for the State process recommendations is no later than 60 days after the application receipt date. FDA does not guarantee to accommodate or explain SPOC comments that are received after the 60-day cutoff. E. Funding Restrictions These grants are not to fund or conduct food inspections for food safety regulatory agencies. They may not be utilized for new building construction, however, remodeling of existing facilities is allowed, provided that remodeling costs do not exceed 25 percent of the grant award amount. F. Other Submission Requirements In anticipation of the Grants.gov electronic application process applicants are encouraged to register with the CCR database. This database is a governmentwide warehouse of commercial and financial information for all organizations conducting business with the Federal Government. Registration with CCR will eventually become a requirement and is consistent with the governmentwide management reform to create a citizen-centered Web presence and build e-gov infrastructures in and across agencies to establish a “single face to industry.” The preferred method for completing a registration is via the Internet at *http://www.ccr.gov* . 1 This Web site provides a CCR handbook with detailed information on data needed prior to beginning the online registration, as well as steps to walk applicants through the registration process. The applicant must have a DUNS number (see section III.C of this document) to begin registration. In order to access Grants.gov an applicant will be required to register with the Credential Provider. Information about this requirement is available at *http://www.grants.gov/CredentialProvider* . 1 V. Application Review Information A. Criteria 1. General Information FDA grants management and program staff will review applications sent in response to this document. To be responsive, an application must be submitted in accordance with the requirements of this document. If an application is found to be nonresponsive, it will be returned to the applicant without further consideration. Applicants are strongly encouraged to contact FDA to resolve any questions about criteria before submitting an application. Please direct all questions of a technical or scientific nature to ORA program staff and all questions of an administrative or financial nature to the grants management staff (see section VII of this document). To be a FERN radiological laboratory, an applicant institution must have an approval letter from the FERN National Program Office approving the applicant institution as a FERN Radiological laboratory prior to the application receipt date of August 24, 2007. 2. Scientific/Technical Review Criteria Applications will be considered for funding on the basis of their overall technical merit as determined through the review process. Program criteria will include availability of funds and overall program balance in terms of geography with respect to existing and projected laboratory sample analysis and testing capacity and capability. Final funding decisions will be made by the Commissioner of Food and Drugs or his designee. A responsive application will be reviewed and evaluated for scientific and technical merit by an ad hoc panel of experts in the subject field of the specific application. Funding decisions will be made by the Commissioner or his designee. A score will be assigned to each responsive application based on the scientific/technical review criteria. The review panel may advise the program staff about the appropriateness of the proposal to the goals of the Division of Federal-State Relations cooperative agreement. 3. Program Review Criteria All grant application projects that are developed at State, local, and tribal levels must have national implication or application that can enhance Federal food safety and security programs. At the discretion of FDA, successful project formats will be made available to interested Federal, State, local, and tribal government FERN laboratories. B. Anticipated Announcement and Award It is anticipated that notification regarding the results of the review in the form of a summary statement will be sent to the applicant by September 26, 2007. It is anticipated that all awards will be made by September 30, 2007. VI. Award Administration Information A. Award Notices FDA's grants management office will notify applicants who have been selected for an award. A Notice of Grant Award will be signed by the FDA Chief Grants Management Officer and be sent to the applicant by mail or transmitted electronically. B. Administrative and National Policy Please note as of October 1, 2006, the HHS Grants Policy Statement

(GPS)(available at *http://www.hhs.gov/grantsnet/adminis/gpd/index.htm* 1 ) supersedes in its entirety the Public Health Service

(PHS)GPS, dated April 1, 1994, and addendum dated January 24, 1995. Awards issued through this program are subject to the HHS GPS requirements that are applicable to you based on the type of organization and the purpose of the award. This includes any requirements in Parts I and II of the HHS GPS that apply to an award. Although consistent with the HHS GPS and applicable statutory and regulatory requirements, these agreements will be subject to all policies and requirements that govern the research grant programs of PHS, including provisions of 42 CFR part 52, 45 CFR parts 74 and 92, and the HHS GPS. Applicants must adhere to the requirements of this document. Special terms and conditions regarding FDA regulatory requirements and adequate progress of the study may be part of the awards notice. PHS strongly encourages all grant recipients to provide a smoke-free workplace and to discourage the use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. FDA is committed to achieving the health promotion and disease prevention objectives of “Healthy People 2010,” a national effort designed to reduce morbidity and mortality and to improve quality of life. Applicants may obtain a paper copy of the “Healthy People 2010” objectives, vols. I and II, for $70 ($87.50 foreign) S/N 017-000-00550-9, by writing to the Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Telephone orders can be placed to 202-512-2250. The document is also available in CD-ROM format, S/N 017-001-00549-5 for $19 ($23.50 foreign) as well as on the Internet at *http://www.healthypeople.gov* 1 under “Publications.” C. Reporting 1. Reporting Requirements The original and two copies of an annual Financial Status Report

(FSR)(SF-269) must be sent to FDA's grants management officer within 90 days of the budget period end date of the grant. Failure to file the FSR in a timely fashion will be grounds for suspension or termination of the grant. A final FSR will be due 90 days after the expiration of the project period as noted on the Notice of Grant Award. For continuing cooperative agreements, quarterly reports and an annual program progress report are also required. For such cooperative agreements, the noncompeting continuation application (PHS 5161-1) will be considered the program progress report for the fourth quarter of the budget period. Quarterly progress reports must contain, but are not limited to the following: • A status report on the installation, training, and operational readiness of any equipment that is provided; • A summary report on any proficiency testing performed; • A summary status of samples analyzed and time to complete individual sample testing; and • A summary description of any other testing performed on the equipment. A final program progress report, final FSR, and a final invention statement must be submitted within 90 days after the expiration of the project period as noted on the Notice of Grant Award. The final program progress report must provide full written documentation of the project and summaries of laboratory operations, as described in the grant application. The documentation must contain sufficient detail such that other State, local, and tribal government FERN laboratories could reproduce the final project. 2. Monitoring Activities The program project officer will monitor grantees periodically. The monitoring may be in the form of telephone conversations, e-mails, or written correspondence between the project office/grants management office and the principal investigator. Periodic site visits with officials of the grantee organization may also occur. The results of these monitoring activities will be recorded in the official grant file and will be available to the grantee upon request consistent with applicable disclosure statutes and with FDA disclosure regulations. Also, the grantee organization must comply with all special terms and conditions of the cooperative agreement, including those which state that future funding of the study will depend on recommendations from the project officer. The scope of the recommendation will confirm that:

(1)There has been acceptable progress on the project;

(2)there is continued compliance with all FDA regulatory requirements;

(3)if necessary, there is an indication that corrective action has taken place; and

(4)assurance that any replacement of personnel will meet the testing requirements. VII. Agency Contacts *Regarding administrative and financial management aspects of this notice please contact* : Michelle Caraffa, Office of Acquisition Support and Grants (HFA-500), Food and Drug Administration, 5630 Fishers Lane, rm. 2105, Rockville, MD 20857, 301-827-7025, FAX: 301-827-7101, e-mail *Michelle.Caraffa@FDA.HHS.gov* . *Regarding the programmatic or technical aspects of this notice* : April D. Kidd, Division of Federal-State Relations (HFC-150), Food and Drug Administration, 5600 Fishers Lane, rm. 12-07, Rockville, MD 20857, 301-827-2913, e-mail: *april.kidd@fda.hhs.gov* . VIII. Other Information Data included in the application may be entitled to confidential treatment as trade secret or confidential commercial information within the meaning of the Freedom of Information Act and FDA's implementing regulations (21 CFR 20.61). Unless disclosure is required under the Freedom of Information Act as amended (5 U.S.C. 552), as determined by the freedom of information officials of HHS or by a court, data contained in the portions of the application that have been specifically identified by page number, paragraph, etc., by the applicant as containing restricted information, shall not be used or disclosed except for evaluation purposes. Dated: July 27, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-15061 Filed 8ndash;2-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D-0268] Guidance for Industry and Food and Drug Administration Staff; “Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology;” Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of the guidance entitled “Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology.” This guidance document describes a means by which the absorbable poly(hydroxybutyrate) surgical suture produced by recombinant deoxyribonucleic acid

(DNA)technology may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the **Federal Register** , FDA is publishing a final rule to classify these device types into class II (special controls). DATES: Submit written or electronic comments on this guidance at any time. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the guidance document entitled “Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology” 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 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: Nada O. Hanafi, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3555. SUPPLEMENTARY INFORMATION: I. Background This guidance describes a means by which the absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology may comply with the requirement of special controls for class II devices. An absorbable poly(hydroxybutyrate) surgical suture is an absorbable surgical suture made of material isolated from prokaryotic cells produced by recombinant DNA technology. The device is intended for use in general soft tissue approximation and ligation. This guidance describes FDA's recommendations regarding physical and performance characteristics, biocompatibility, sterility, expiration dating, and labeling. II. Significance of Guidance This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on absorbable poly(hydroxybutyrate) surgical sutures produced by recombinant DNA technology. 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 guidance may do so by using the Internet. To receive “Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology,” 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 1629 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 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; the collections of information in 21 CFR part 820 have been approved under OMB control number 0910-0073; the collections of information in 21 CFR part 812 have been approved under OMB control number 0910-0078; the collections of information in 21 CFR parts 56 and 50 have been approved under OMB control number 0910-0014. 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 23, 2007. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E7-15063 Filed 8-2-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration

(HRSA)publishes periodic summaries of proposed projects being developed for submission to OMB under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, call the HRSA Reports Clearance Officer on

(301)443-1129. Comments are invited on:

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

(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;

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

(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Proposed Project: Application for the National Health Service Corps

(NHSC)Scholarship Program (OMB No. 0915-0146): Revision The National Health Service Corps

(NHSC)Scholarship Program's mission is to ensure the geographic representation of physicians and other health practitioners in the United States. Under this program, health professions students are offered scholarships in return for service in a federally designated Health Professional Shortage Area (HPSA). The Scholarship Program provides the NHSC with the health professionals it requires to carry out its mission of providing primary health care to HPSA populations in areas of greatest need. Students are supported who are well qualified to participate in the NHSC Scholarship Program and who want to assist the NHSC in its mission, both during and after their period of obligated service. The application form is being revised to streamline the application process and collect the most relevant information necessary to make determinations of award. Scholars are selected for these competitive awards based on the information provided in the application and supporting documentation. Awards are made to applicants who demonstrate a high potential for providing quality primary health care services. Estimated Response Burden Form Number of respondents Responses per respondent Hours per response Total burden hours Application 1800 1 2 3600 Total 1800 600 Written comments and recommendations concerning the proposed information collection should be sent within 60 days of this notice to: Susan G. Queen, PhD, HRSA Reports Clearance Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. Dated: July 27, 2007. Alexandra Huttinger, Acting Director, Division of Policy Review and Coordination. [FR Doc. E7-15107 Filed 8-2-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Committee on Heritable Disorders and Genetic Diseases in Newborns and Children; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given of the following meeting: *Name:* Advisory Committee on Heritable Disorders and Genetic Diseases in Newborns and Children (ACHDGDNC). *Dates and Times:* Sept 17, 2007, 9 a.m. to 5 p.m. Sept 18, 2007, 8:30 a.m. to 2 p.m. *Place:* Ronald Reagan Building and International Trade Center, Rotunda Room, 1300 Pennsylvania Avenue, NW., Washington, DC 20004. *Status:* The meeting will be open to the public with attendance limited to space availability. *Purpose:* The ACHDGDNC was established to advise and guide the Secretary regarding the most appropriate application of universal newborn screening tests, technologies, policies, guidelines and programs for effectively reducing morbidity and mortality in newborns and children having or at risk for heritable disorders. The ACHDGDNC also provides advice and recommendations concerning the grants and projects authorized under the Heritable Disorders Program. *Agenda:* The meeting will include a presentation and continued discussions on the nomination/evaluation process for newborn screening candidate conditions. There will be reports from the Secretary's Advisory Committee on Genetics, Health and Society's Workgroup on Oversight of Genetic Tests and from the Advisory Committee on Heritable Disorders' Workgroup on Research Agenda, as well as the continued work and reports of the ACHDGDNC's subcommittees on laboratory standards and procedures, follow-up and treatment, and education and training. Proposed agenda items are subject to change. Time will be provided for public comment. Individuals who wish to provide public comment or who plan to attend the meeting and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the ACHDGDNC Staff, Jill F. Shuger, M.S. (contact information provided below). *Contact Person* : Anyone interested in obtaining a roster of members or other relevant information should write or contact Jill F. Shuger, M.S., Maternal and Child Health Bureau, Health Resources and Services Administration, Room 18A-19, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857, Telephone

(301)443-1080, *jshuger@hrsa.gov.* Information on the Advisory Committee is available at *http://mchb.hrsa.gov/programs/genetics/committee.* Dated: July 26, 2007. Alexandra Huttinger, Acting Director, Division of Policy Review and Coordination. [FR Doc. E7-15103 Filed 8-2-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Advisory Council on the National Health Service Corps; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given of the following meeting: *Name:* National Advisory Council on the National Health Service Corps. *Dates and Times:* September 6, 2007, 2 p.m.-5 p.m.; September 7, 2007, 8:30 a.m.-5 p.m.; and September 8, 2007, 9 a.m.-5 p.m. *Place:* Hilton Washington DC/Rockville Executive Meeting Center, 1750 Rockville Pike, Rockville, Maryland 20852. *Status:* The meeting will be open to the public. *Agenda:* The Council will be developing recommendations for the National Health Service Corps Program. Discussions will be focused on the impact of these recommendations on the program participants, communities served by these clinicians and in the administration of the program. *For Further Information Contact:* Tira Patterson, Bureau of Clinician Recruitment and Service, Health Resources and Services Administration, Parklawn Building, Room 8A-55, 5600 Fishers Lane, Rockville, MD 20857; e-mail: *TPatterson@hrsa.gov* ; telephone:

(301)594-4140. Dated: July 27, 2007. Alexandra Huttinger, Acting Director, Division of Policy Review and Coordination. [FR Doc. E7-15102 Filed 8-2-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Committee on Training in Primary Care Medicine and Dentistry; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given of the following meeting: *Name:* Advisory Committee on Training in Primary Care Medicine and Dentistry. *Date and Time:* September 6, 2007, 8:30 a.m.—4:30 p.m. and September 7, 2007, 8 a.m.—2 p.m. *Place:* Hilton Washington, DC/Rockville Executive Meeting Center, 1750 Rockville Pike, Rockville, Maryland 20852. *Status:* The meeting will be open to the public. *Purpose:* The Advisory Committee provides advice and recommendations on a broad range of issues dealing with programs and activities authorized under section 747 of the Public Health Service Act as amended by The Health Professions Education Partnership Act of 1998, Public Law 105-392. At this meeting the Advisory Committee will work on its seventh report on the topic of primary care providing a medical/dental home within the health care system. The report will be submitted to Congress and to the Secretary of the Department of Health and Human Services. *Agenda:* The meeting on Thursday, September 6 will begin with opening comments from the Chair of the Advisory Committee and introductory remarks from senior management of the Health Resources and Services Administration. Several speakers will address the topic of patient-centered medical/dental home as a model for health care and training requirements for primary care practitioners. An opportunity will be provided for professional organizations to give comment on the topic. In both small groups and in the plenary session, the Advisory Committee will work on various parts of the report. An opportunity will be provided for public comment. On Friday, September 7, the Advisory Committee will continue work on the seventh report in small groups and in the plenary session. The Advisory Committee will plan next steps in the report preparation process. An opportunity will be provided for public comment. FOR FURTHER INFORMATION CONTACT: Anyone interested in obtaining a roster of members or other relevant information should write or contact Jerilyn K. Glass, M.D., Ph.D., Division of Medicine and Dentistry, Bureau of Health Professions, Health Resources and Services Administration, Room 9A-27, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857, Telephone

(301)443-6785. The Web address for information on the Advisory Committee is *http://bhpr.hrsa.gov/medicine-dentistry/actpcmd* . Dated: July 26, 2007. Alexandra Huttinger, Acting Director, Division of Policy Review and Coordination. [FR Doc. E7-15100 Filed 8-2-07; 8:45 am] BILLING CODE 4165-15-P 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. Development of Dengue Virus Type 3 Vaccine Candidates Containing Either 1) Nucleotide Deletions in the 3′-UTR of the Genome Consisting of More Than 30 Contiguous Nucleotides in One or Multiple Regions, or 2) a 3′-UTR Derived From DEN4 and Containing the A30 Nucleotide Deletion Description of Technology: The disease burden associated with dengue virus infection has increased over the past several decades in the tropical and semi-tropical regions of the world, where over 2 billion people live at risk of dengue infection. Annually, there are an estimated fifty

(50)to one hundred

(100)million cases of dengue fever, making development of an effective vaccine a priority. In addition, there is a need for a “travelers vaccine” to protect those visiting dengue virus endemic areas, similar in scope to other currently available “travelers vaccines”, such as hepatitis A vaccine. The previously identified Δ30 attenuating mutation, created in each dengue virus serotype by the removal of 30 homologous nucleotides from the 3′-UTR, is capable of attenuating wild-type strains of dengue virus type 1 (DEN1), type 4

(DEN4)and to a limited extent type 2 (DEN2). These DEN1Δ30 and DEN4Δ30 viruses have been shown to be both safe and immunogenic in humans. However, the Δ30 mutation failed to have an attenuating effect on dengue virus type 3 (DEN3). To generate DEN3 vaccine candidates with a clearly attenuated phenotype, viruses were produced containing 3′-UTR deletions consisting of extensions of the original Δ30 mutation or additional mutations which remove stem-loop structures similar to those removed by Δ30. In addition, the entire 3′-UTR of DEN3 was replaced with the 3′-UTR derived from DEN4 and containing the Δ30 mutation. Studies in monkeys demonstrated that these newly developed viruses are highly attenuated, yet sufficiently immunogenic to warrant their further development for use as live attenuated vaccine candidates. Such viruses are anticipated to become the DEN3 component of a tetravalent vaccine formulation designed to immunize against all four dengue virus serotypes. Application: Immunization against all four serotypes of Dengue Virus. Developmental Status: Vaccine candidates have been synthesized and preclinical studies have been performed. The vaccine candidates of this invention are slated to enter Phase I clinical trials in the next year. Inventors: Stephen S. Whitehead, Joseph E. Blaney, Brian R. Murphy (NIAID). Patent Status: U.S. Provisional Application No. 60/837,723 filed 15 Aug. 2006 (HHS Reference No. E-139-2006/0-US-01). Licensing Status: Available for exclusive or non-exclusive licensing. Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646; *soukasp@mail.nih.gov* Collaborative Research Opportunity: The National Institute of Allergy and Infectious Diseases, Laboratory of Infectious Diseases, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize these vaccines. Please contact Dr. Brian Murphy at 301-594-1616 or *bm25f@nih.gov* for more information. Dengue Tetravalent Vaccine Containing a Common 30-Nucleotide Deletion in the 3′-UTR of Dengue Types 1, 2, 3, and 4 Description of Technology: The invention relates to a dengue virus tetravalent vaccine containing a common 30-nucleotide deletion (Δ30) in the 3'-untranslated region

(UTR)of the genome of dengue virus serotypes 1, 2, 3, and 4. The previously identified Δ30 attenuating mutation, created in dengue virus type 4

(DEN4)by the removal of 30 nucleotides from the 3′-UTR, is also capable of attenuating a wild-type strain of dengue virus type 1 (DEN1). Removal of 30 nucleotides from the DEN1 3′-UTR in a highly conserved region homologous to the DEN4 region encompassing the Δ30 mutation yielded a recombinant virus attenuated in rhesus monkeys to a level similar to recombinant virus DEN4Δ30. This established the transportability of the Δ30 mutation and its attenuation phenotype to a dengue virus type other than DEN4. The effective transferability of the Δ30 mutation establishes the usefulness of the Δ30 mutation to attenuate and improve the safety of commercializable dengue virus vaccines of any serotype. A tetravalent dengue virus vaccine containing dengue virus types 1, 2, 3, and 4 each attenuated by the Δ30 mutation is being developed. The presence of the Δ30 attenuating mutation in each virus component precludes the reversion to a wild-type virus by intertypic recombination. In addition, because of the inherent genetic stability of deletion mutations, the Δ30 mutation represents an excellent alternative for use as a common mutation shared among each component of a tetravalent vaccine. Inventors: Stephen S. Whitehead (NIAID), Brian R. Murphy (NIAID), Lewis Markoff (FDA), Barry Falgout (FDA), Kathryn A. Hanley (NIAID), Joseph E. Blaney (NIAID). Patent Status: U.S. Patent Application No. 10/970,640 filed 21 Oct. 2004, claiming priority to 03 May 2002 (HHS Reference No. E-089-2002/1-US-02). Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646; *soukasp@mail.nih.gov* . Collaborative Research Opportunity: The National Institute of Allergy and Infectious Diseases, Laboratory of Infectious Diseases, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize these vaccines. Please contact Dr. Brian Murphy at 301-594-1616 or *bm25f@nih.gov* for more information. Development of Mutations Useful for Attenuating Dengue Viruses and Chimeric Dengue Viruses Description of Technology: Although flaviviruses cause a great deal of human suffering and economic loss, there is a shortage of effective vaccines. This invention relates to dengue virus mutations that may contribute to the development of improved dengue vaccines. Site directed and random mutagenesis techniques were used to introduce mutations into the dengue virus genome and to assemble a collection of useful mutations for incorporation in recombinant live attenuated dengue virus vaccines. The resulting mutant viruses were screened for several valuable phenotypes, including temperature sensitivity in Vero cells or human liver cells, host cell restriction in mosquito cells or human liver cells, host cell adaptation for improved replication in Vero cells, and attenuation in mice or in mosquitoes. The genetic basis for each observed phenotype was determined by direct sequence analysis of the genome of the mutant virus. Mutations identified through these sequencing efforts have been further evaluated by re-introduction of the identified mutations, singly, or in combination, into recombinant dengue virus and characterization of the resulting recombinant virus for phenotypes. In this manner, a menu of attenuating and growth promoting mutations was developed that is useful in fine-tuning the attenuation and growth characteristics of dengue virus vaccine candidates. The mutations promoting growth in Vero cells have usefulness for the production of live or inactivated dengue virus vaccines. Inventors: Stephen S. Whitehead, Brian R. Murphy, Kathryn A. Hanley, Joseph E. Blaney (NIAID). Patent Status: U.S. Patent No. 7,226,602 issued 05 Jun 2007 (HHS Reference No. E-120-2001/0-US-04); U.S. Patent Application No. 11/446,050 filed 02 Jun 2006 (HHS Reference No. E-120-2001/0-US-10). Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646; *soukasp@mail.nih.gov* . Collaborative Research Opportunity: The National Institute of Allergy and Infectious Diseases, Laboratory of Infectious Diseases, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize these vaccines. Please contact Dr. Brian Murphy at 301-594-1616 or *bm25f@nih.gov* for more information. Dated: July 27, 2007. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E7-15054 Filed 8-2-07; 8:45 am] BILLING CODE 4140-01-P 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. Immunogenic Peptides and Methods of Use for Treating Prostate and Uterine Cancers *Description of Technology:* Cancer of the prostate is the most commonly diagnosed cancer in men and the second leading cause of cancer death in men. Despite the use of standard therapy, including surgery, radiotherapy, chemotherapy, and/or hormonal therapy more than 30,000 men will die from prostate cancer. Moreover, current therapy has limited success against metastatic androgen insensitive prostate cancer. A potential treatment for prostate cancer is immunotherapy, either alone or in combination with standard therapies. PAGE4 is an X chromosome-linked cancer-testis antigen that is highly expressed in prostate and uterine cancers. To this end, Drs. Jeffery Schlom, Kwong Tsang, and Ira Pastan have identified and characterized novel PAGE4 cytotoxic T-cell lymphocyte

(CTL)epitopes and enhanced agonist epitopes. Preclinical studies performed by Dr. Schlom and colleagues indicate that the PAGE4 agonist epitopes bind HLA-A2 molecules at lower peptide concentrations, form more stable peptide HLA-A2 complexes, induce higher levels of production of INF-gamma, Granzyme B, TNF-alpha, IL-2, and lymphotactin by PAGE4 specific T-cell lines, and T-cell lines generated against the agonist peptide were more efficient at lysing human tumor cells expressing native PAGE4. Thus, these agonist epitopes of PAGE4 could be incorporated into immunotherapy protocols, and may constitute an alternative and/or additional approach for the treatment of PAGE4 expressing prostate and uterine cancers. *Development Status:* The Laboratory of Tumor Immunology and Biology plans to initiate clinical studies utilizing this technology and collaborative opportunities may be available. *Inventors:* Jeffrey Schlom, Kwong-Yok Tsang, Ira H. Pastan (NCI). *Publications:* Publications which may provide background information for this technology include: 1. J Yokokawa *et al.* , “Identification of cytotoxic T-lymphocyte epitope(s) and its agonist epitope(s) of a novel target for vaccine therapy (PAGE4),” *Int J Cancer.* 2007;121:595-605. 2. C Iavarone *et al.* , “PAGE4 is a cytoplasmic protein that is expressed in normal prostate and in prostate cancers,” *Mol Cancer Ther.* 2002 Mar;1(5):329-335. 3. L Prikler *et al.* , “Adaptive immunotherapy of the advanced prostate cancer—cancer testis antigen

(CTA)as possible target antigens,” *Aktuelle Urol.* 2004 Aug;35(4):326-330. [article in German] *Patent Status:* PCT Application No. PCT/US2007/004603 filed 21 Feb 2007 (HHS Reference No. E-104-2006/0-PCT-02), claiming priority to 24 Feb 2006, entitled “Immunogenic Peptides and Methods of Use.” *Related Technology:* U.S. Patent Application No. 11/704,714 filed 09 Feb 2007 (HHS Reference No. E-028-1999/0-US-08), claiming priority to 01 Sep 1998, entitled “PAGE-4, An X-Linked GAGE-Like Gene Expressed in Normal and Neoplastic Prostate, Testis and Uterus, and Uses Therefor.” *Licensing Status:* Available for non-exclusive or exclusive licensing. *Licensing Contact:* Michelle A. Booden, Ph.D.; 301/451-7337; *boodenm@mail.nih.gov.* *Collaborative Research Opportunity:* The Laboratory of Tumor Immunology and Biology, Center for Cancer Research, NCI is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. Please contact Kevin Chang, Ph.D. in the NCI Technology Transfer Center at *changke@mail.nih.gov* and/or 301-496-0477 for more information. Diagnostic and Therapeutic Methods of Detecting and Treating Cancers of Reproductive Tissues *Description of Technology:* PAGE-4 is a human X-linked gene that is strongly expressed in prostate and prostate cancer, and is also expressed in other male and female reproductive tissue (e.g., testis, fallopian tube, placenta, uterus, and uterine cancer). PAGE-4 shows similarity with the GAGE protein family, but it diverges significantly from members of the family so that it appears to belong to a separate family. This, and the existence of another gene, PAGE-2, that share more homology with PAGE-4 than with members of the GAGE family indicates that the PAGE-4 protein belongs to a separate protein family. The specific detection of PAGE-4 might be valuable for the diagnosis of prostate and testicular tumors, as well as uterine tumors. There are sufficient differences between PAGE-4 and other members of the PAGE and MAGE proteins to produce specific antibodies. Analyses with such antibodies are needed to confirm by immunohistology the expression specificity that is seen in database and mRNA analyses, and to evaluate whether anti-PAGE-4 immunotherapy could be a promising therapeutic approach. One possibility of eliminating PAGE-4 expressing cells could be to use it as cancer vaccine. Among the many possible approaches to vaccination, one method is direct vaccination with plasmid DNA. In fact, Dr. Pastan's laboratory has been able to obtain good expression of the PAGE-4 protein with mammalian expression plasmids, and has demonstrated that DNA-immunization with such expression constructs leads to good immune responses. Hence, this method may generate anti-PAGE-4 responses, and allow us to analyze if “PAGE-4-vaccination” can eliminate PAGE-4 expressing cells, as a therapeutic approach towards neoplasms of the prostate, testis, and uterus. *Inventors:* Ira H. Pastan, Ulrich Brinkmann, George Vasmatzis, Byungkook Lee (NCI). *Patent Status:* U.S. Patent Application No. 11/704,714 filed 09 Feb 2007 (HHS Reference No. E-028-1999/0-US-08), claiming priority to 01 Sep 1998, entitled “PAGE-4, An X-Linked GAGE-Like Gene Expressed in Normal and Neoplastic Prostate, Testis and Uterus, and Uses Therefor.” *Related Technology:* PCT Application No. PCT/US2007/004603 filed 21 Feb 2007 (HHS Reference No. E-104-2006/ 0-PCT-02), claiming priority to 24 Feb 2006, entitled “Immunogenic Peptides and Methods of Use.” *Licensing Contact:* Jesse S. Kindra, J.D.; 301/435-5559; *kindraj@mail.nih.gov;* or Michelle A. Booden, PhD.; 301/451-7337; *boodenm@mail.nih.gov.* Dated: July 26, 2007. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E7-15056 Filed 8-2-07; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health ODS Analytical Methods and Reference Materials Program Stakeholders' Meeting Notice Notice is hereby given of the National Institutes of Health

(NIH)Office of Dietary Supplements

(ODS)Analytical Methods and Reference Materials Program Stakeholders' Meeting to be held Monday, September 10, 2007, in the Lister Hill Auditorium on the NIH Campus in Bethesda, Maryland 20892. The meeting will begin at 9 a.m. and will be open to the public. In fiscal year

(FY)2002, Congress addressed the need for support of analytical methods and reference materials development related to dietary supplements. The congressional appropriations language supported an increased ODS budget for several topics, including analytical methods and reference materials. The Senate language called for “ODS to allocate sufficient funds to speed up an ongoing collaborative effort to develop and disseminate validated analytical methods and reference materials for the most commonly used botanicals and other dietary supplements.” On February 8, 2002, ODS held a public meeting to solicit comments to assist ODS in designing an overall strategy for implementing the congressional mandate to foster development and validation of analytical methods and reference materials for dietary supplements. In FY 2004 and 2005, Congress again used similar language supporting the Analytical Methods and Reference Materials

(AMRM)program in the ODS appropriations. The purpose of the proposed meeting on September 10, 2007, is to state the progress that has been made by the AMRM program since its inception five years ago and to receive comments on directions for the next five years. The meeting is intended to seek stakeholder comments that will assist us with the continued implementation of an overall strategy for research, development, validation, and dissemination of analytical methods and standard reference materials for dietary supplement ingredients. The sponsor of this meeting is the NIH Office of Dietary Supplements. Registration: Ms. Channet Williams of the American Institutes of Research will be coordinating the registration for this meeting. To register, please forward your name and complete mailing address, including phone number, via e-mail to *cwilliams@air.org.* If you don't have access to e-mail, please call Ms. Williams at 301-592-2130. American Institutes for Research's mailing address is 10720 Columbia Pike, Silver Spring, Maryland 20901. Registration information, as well as background information about the AMRM program, is available at *http://www.ods.od.nih.gov.* If you wish to make an oral presentation during the meeting, you must indicate this when you register and submit the following information:

(1)A brief written statement of the general nature of the statement that you wish to present,

(2)the names and addresses of the person(s) who will give the presentation, and

(3)the approximate length of time that you are requesting for your presentation. Depending on the number of people who register to make presentations, we may have to limit the time allotted for each presentation. Please Note: The NIH has instituted new security measures to ensure the safety of NIH employees and property. All visitors must be prepared to show a photo ID upon request. Visitors may be required to pass through a metal detector and have bags, backpacks, or purses inspected or x-rayed as they enter NIH buildings. For more information about the new security measures at NIH, please visit the Web site at *http://www.nih.gov/about/visitorsecurity.htm.* Dated: July 25, 2007. Elias A. Zerhouni, Director, National Institutes of Health. [FR Doc. E7-15048 Filed 8-2-07; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of General Medical Sciences; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the National Advisory General Medical Sciences Council. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(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 Advisory General Medical Sciences Council, *Date:* September 10-11, 2007. *Closed:* September 10, 2007, 8:30 a.m. to 5 p.m. *Agenda:* To Review and Evaluate Grant Applications. *Place:* National Institutes of Health, Natcher Building, Conference Rooms E1 & E2, 9000 Rockville Pike, Bethesda, MD 20892. *Open:* September 11, 2007, 8:30 a.m. to adjournment. *Agenda:* For the Discussion of Program Policies and Issues, Opening Remarks, Report of the Director, NIGMS, and Other Business of the Council. *Place:* National Institutes of Health, Natcher Building, Conference Rooms E1 & E2, 9000 Rockville Pike, Bethesda, MD 20892. *Contact Person:* Ann A. Hagan, PhD, Associate Director for Extramural Activities, NIGMS, NIH, DHHS, 45 Center Drive, Room 2AN24H, MSC6200, Bethesda, MD 20892-6200,

(301)594-4499. *hagana@nigms.nih.gov* . Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit. Information is also available on the Institute's Center's home page: *http://www.nigms.nih.gov/about/advisory_council.html,* where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.375, Minority Biomedical Research Support; 93.821, Cell Biology and Biophysics Research; 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.862, Genetics and Developmental Biology Research; 93.88, Minority Access to Research Careers; 93.96, Special Minority Initiatives, National Institutes of Health, HHS). Dated: July 25, 2007. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 07-3775 Filed 8-2-07; 8:45 am]

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