Notices. Notice

7,502 words·~34 min read·/register/2007/07/24/07-3587

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 Food and Drug Administration [Docket No. 2007N-0105] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Mental Models Study of Food Terrorism Risk Awareness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

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

(OMB)for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by August 23, 2007. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974, or e-mailed to *baguilar@omb.eop.gov* . All comments should be identified with the OMB control number “0910-NEW” and title “Mental Models Study of Food Terrorism Risk Awareness.” Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Mental Models Study of Food Terrorism Risk Awareness (OMB Control Number 0910-NEW) The proposed information collection will help FDA protect the public from food terrorism by preparing the agency to take appropriate action in the event of a crisis. Under the Federal Food, Drug, and Cosmetic Act of 1938, as amended, FDA has authority to act to protect the safety of the nation's food supply. Under title 42 of the Public Health Service Act (1944), FDA has authority to act to protect the public health. In addition, title III of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Public Law 107-188), FDA has authority to act to improve the ability of the United States to prevent, prepare for, and respond to terrorism and other public health emergencies. FDA has crafted and disseminated messages intended to raise the awareness of state and local government agency and industry representatives regarding food defense issues and preparedness; but, FDA does not currently have similar initiatives for consumers. Extensive research exists in disaster preparedness and in effective communication to the public of risk or crisis information by government or non-government entities. However, additional research is needed to help FDA design communications that will increase consumer awareness of the potential for food terrorism and help consumers to make good decisions in the event of a food terrorism emergency. The project will use “mental modeling,” a qualitative research method wherein the decisionmaking processes of a group of consumer respondents (described in the next paragraph) concerning food terrorism are modeled and compared to a model based on expert knowledge and experience in food terrorism. The information will be collected via a telephone interview concerning the factors that influence the perceptions and motivations related to the threat of food terrorism. A comparison between expert and consumer models based on the collected information may identify “consequential knowledge gaps” that can be redressed through messages or information campaigns designed by FDA. *Description of Respondents* : Respondents will be adult parents over the age of 18 who have at least one child age 4 to 13 residing in the home at least half-time. The sample will be divided by gender. In the **Federal Register** of March 30, 2007 (72 FR 15140), 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 No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 45 1 1 .75 33.75 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: July 17, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-14200 Filed 7-23-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0279] Agency Information Collection Activities; Proposed Collection; Comment Request; Color Additive Certification Requests and Recordkeeping AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA's regulations governing batch certification of color additives manufactured for use in foods, drugs, cosmetics or medical devices in the United States. DATES: Submit written or electronic comments on the collection of information by September 24, 2007. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.fda.gov/dockets/ecomments* . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget

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

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

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

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

(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Color Additive Certification Requests and Recordkeeping—21 CFR Part 80 (OMB Control Number 0910-0216)—Extension FDA has regulatory oversight for color additives used in foods, drugs, cosmetics, and medical devices. Section 721(a) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 379e(a)) provides that a color additive shall be deemed to be unsafe unless it meets the requirements of a listing regulation, including any requirement for batch certification, and is used in accordance with the regulation. FDA lists color additives that have been shown to be safe for their intended uses in title 21 of the Code of Federal Regulations (CFR). FDA requires batch certification for all color additives listed in 21 CFR part 74 and for all color additives provisionally listed in 21 CFR part 82. Color additives listed in 21 CFR part 73 are exempted from certification. The requirements for color additive certification are described in 21 CFR part 80. In the certification procedure, a representative sample of a new batch of color additive, accompanied by a “request for certification” that provides information about the batch, must be submitted to FDA's Office of Cosmetics and Colors. FDA personnel perform chemical and other analyses of the representative sample and, providing the sample satisfies all certification requirements, issue a certification lot number for the batch. FDA charges a fee for certification based on the batch weight and requires manufacturers to keep records of the batch pending and after certification. Under § 80.21, a request for certification must include: Name of color additive, manufacturer's batch number and weight in pounds, name and address of manufacturer, storage conditions, statement of use(s), certification fee, and signature of person requesting certification. Under § 80.22, a request for certification must include a sample of the batch of color additive that is the subject of the request. The sample must be labeled to show: Name of color additive, manufacturer's batch number and quantity, and name and address of person requesting certification. Under § 80.39, the person to whom a certificate is issued must keep complete records showing the disposal of all the color additive covered by the certificate. Such records are to be made available upon request to any accredited representative of FDA until at least 2 years after disposal of all of the color additive. The purpose for collecting this information is to help FDA assure that only safe color additives will be used in foods, drugs, cosmetics, and medical devices sold in the United States. The required information is unique to the batch of color additive that is the subject of a request for certification. The manufacturer's batch number is used for temporarily identifying a batch of color additive until FDA issues a certification lot number and for identifying a certified batch during inspections. The manufacturer's batch number also aids in tracing the disposal of a certified batch or a batch that has been refused certification for noncompliance with the color additive regulations. The manufacturer's batch weight is used for assessing the certification fee. The batch weight also is used to account for the disposal of a batch of certified or certification-rejected color additive. The batch weight can be used in a recall to determine whether all unused color additive in the batch has been recalled. The manufacturer's name and address and the name and address of the person requesting certification are used to contact the person responsible should a question arise concerning compliance with the color additive regulations. Information on storage conditions pending certification is used to evaluate whether a batch of certified color additive is inadvertently or intentionally altered in a manner that would make the sample submitted for certification analysis unrepresentative of the batch. FDA checks storage information during inspections. Information on intended uses for a batch of color additive is used to assure that a batch of certified color additive will be used in accordance with the requirements of its listing regulation. The statement of the fee on a certification request is used for accounting purposes so that a person requesting certification can be notified promptly of any discrepancies. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 80.21 32 174 5,568 0.20 1,114 80.22 32 174 5,568 0.05 278 **Total** 0.25 1,392 1 There are no capital costs or operating and maintenance costs associated with this collection of information. **Table 2.—Estimated Annual Recordkeeping Burden** 1 21 CFR Section No. of Recordkeepers Annual Frequency of Recordkeeping Total Annual Records Hours per Record Total Hours 80.39 32 174 5,568 0.25 1,392 **Total** 1,392 1 There are no capital costs or operating and maintenance costs associated with this collection of information. FDA bases its estimate on its review of the certification requests received over the past 3 fiscal years (FY). The annual burden estimate for this information collection is 2,784 hours. The estimated reporting burden for this information collection is 1,392 hours and the estimated recordkeeping burden for this information collection is 1,392 hours. From FY 2004 to FY 2006, FDA processed an average of 5,568 responses (requests for certification of batches of color additives) per year. There were 32 different respondents, corresponding to an average of approximately 174 responses from each respondent per year. Using information from industry personnel, FDA estimates that an average of 0.25 hour per response is required for reporting (preparing certification requests and accompanying sample labels) and an average of 0.25 hour per response is required for recordkeeping. On February 13, 2006, FDA introduced a Web-based Color Certification information system. The system was fully operational for FY 2007. This system allows certifiers to request color certification on-line, follow their submissions through the process, and obtain information on account status. The system sends back the certification results electronically, allowing certifiers to sell their certified color before receiving hard copy certificates. Any delays in the system result only from shipment of color additive samples to FDA's Office of Cosmetics and Colors for analysis. FDA expects future reductions in the hour burdens for reporting and recordkeeping from use of the Web-based system. Dated: July 17, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-14201 Filed 7-23-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Request for Notification From Industry Organizations Interested in Participating in Selection Process for Nonvoting Industry Representatives on Public Advisory Panels or Committees and Request for Nonvoting Industry Representatives on Public Advisory Panels or Committees AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on the National Mammography Quality Assurance Advisory Committee (NMQAAC) and certain device panels of the Medical Devices Advisory Committee in the Center for Devices and Radiological Health notify FDA in writing. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice. DATES: Any industry organizations interested in participating in the selection of an appropriate nonvoting member to represent industry interests must send a letter stating that interest to the FDA by August 23, 2007, for the vacancies listed in this notice. Concurrently, nomination materials for prospective candidates should be sent to FDA by August 23, 2007. ADDRESSES: All letters of interest and nominations should be sent to Kathleen L. Walker (see FOR FURTHER INFORMATION CONTACT ). FOR FURTHER INFORMATION CONTACT: Kathleen L. Walker, Center for Devices and Radiological Health (HFZ-17), Food and Drug Administration, 7520 Standish Pl. (MPN1), Rockville, MD 20855, 240-276-8938, e-mail: *kathleen.walker@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: The agency intends to add nonvoting industry representatives to its advisory committee identified below: I. CDRH—Various Committees and Panels A. National Mammography Quality Assurance Advisory Committee (NMQAAC) The Mammography Quality Standards Reauthorization Act of 2004 (Public Law 108-365) requires the addition of at least two industry representatives with expertise in mammography equipment to the NMQAAC. B. Medical Devices Advisory Committee Section 520(f)(3) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360j(f)(3)), as amended by the Medical Device Amendments of 1976, provides that each medical device panel include one nonvoting member to represent the interests of the medical device manufacturing industry. II. CDRH—Committee and Panel Functions FDA is requesting nominations for nonvoting members representing industry interests for the following vacancies listed in table 1 of this document. **Table 1.** Committee Name or Panel Approximate Date Needed NMQAAC-The functions of the NMQAAC are to advise FDA on the following topics:

(1)Developing appropriate quality standards and regulations for mammography facilities,

(2)developing appropriate standards and regulations for bodies accrediting mammography facilities under this program,

(3)developing regulations with respect to sanctions,

(4)developing procedures for monitoring compliance with standards,

(5)establishing a mechanism to investigate consumer complaints,

(6)reporting new developments concerning breast imaging that should be considered in the oversight of mammography facilities,

(7)determining whether there exists a shortage of mammography facilities in rural and health professional shortage areas and determining the effects of personnel on access to the services of such facilities in such areas,

(8)determining whether there will exist a sufficient number of medical physicists after October 1, 1999, and

(9)determining the costs and benefits of compliance with these requirements February 1, 2008 Certain Panel of the Medical Devices Advisory Committee-The medical device panels perform the following functions:

(1)Review and evaluate data on the safety and effectiveness of marketed and investigational devices and make recommendations for their regulation,

(2)advise the Commissioner of Food and Drugs (the Commissioner) regarding recommended classification or reclassification of these devices into one of three regulatory categories,

(3)advise on any possible risks to health associated with the use of devices,

(4)advise on formulation of product development protocols,

(5)review premarket approval applications for medical devices,

(6)review guidelines and guidance documents,

(7)recommend exemption to certain devices from the application of portions of the act,

(8)advise on the necessity to ban a device,

(9)respond to requests from the agency to review and make recommendations on specific issues or problems concerning the safety and effectiveness of devices, and

(10)make recommendations on the quality in the design of clinical studies regarding the safety and effectiveness of marketed and investigational devices. Clinical Chemistry and Clinical Toxicology Devices Panel March 1, 2008 Gastroenterology and Urology Devices Panel January 1, 2008 Medical Devices Dispute Resolution Panel October 1, 2008 Microbiology Devices Panel March 1, 2008 Molecular and Clinical Genetics Devices Panel June 1, 2008 Orthopaedic and Rehabilitation Devices Panel September 1, 2008 Radiological Devices Panel February 1, 2008 III. Selection Procedure Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests should send a letter stating that interest to the contact person (see FOR FURTHER INFORMATION CONTACT ) within 30 days of publication of this notice. Within the subsequent 30 days, FDA will send a letter to each organization that has expressed an interest, attaching a complete list of all such organizations, and a list of all nominees along with their current resumes. The letter will also state that it is the responsibility of the interested organizations to confer with one another and to select a candidate, within 60 days after the receipt of the FDA letter, to serve as the nonvoting member to represent industry interests for a particular committee or device panel. The interested organizations are not bound by the list of nominees in selecting a candidate. However, if no individual is selected within the 60 days, the Commissioner of Food and Drugs will select the nonvoting member to represent industry interests. IV. Qualifications A. NMQAAC Persons nominated for membership as an industry representative on the NMQAAC must meet the following criteria:

(1)Demonstrate expertise in mammography equipment, and

(2)be able to discuss equipment specifications and quality control procedures affecting mammography equipment. The industry representative must be able to represent the industry perspective on issues and actions before the advisory committee, serve as liaison between the committee and interested industry parties, and facilitate dialogue with the advisory committee on mammography equipment issues. B. Medical Devices Advisory Committee Persons nominated for the device panels should be full-time employees of firms that manufacture products that would come before the panel, or consulting firms that represent manufacturers, or have similar appropriate ties to industry. V. Application Procedure Individuals may self nominate and/or an organization may nominate one or more individuals to serve as a nonvoting industry representative. A current curriculum vitae and the name of the committee of interest should be sent to the FDA contact person (see FOR FURTHER INFORMATION CONTACT ) within the 30 days. FDA will forward all nominations to the organizations expressing interest in participating in the selection process for the committee. (Persons who nominate themselves as nonvoting industry representatives will not participate in the selection process). FDA has a special interest in ensuring that women, minority groups, individuals with physical disabilities, and small businesses are adequately represented on its advisory committees, and therefore, encourages, nominations for appropriately qualified candidates from these groups. Specifically, in this document, nominations for nonvoting representatives of industry interests are encouraged from the food production and manufacturing industry; the dietary supplement manufacturing industry; and the agricultural biotechnology manufacturing industry. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14 relating to advisory committees. Dated: July 16, 2007. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E7-14206 Filed 7-23-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection: Comment Request; Revision of OMB; No. 0925-0001/exp. 09/30/07, “Research and Research Training Grant Applications and Related Forms” SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Office of Extramural Research, the National Institutes of Health

(NIH)will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget

(OMB)for review and approval. *Proposed Collection:* Title: Research and Research Training Grant Applications and Related Forms. Type of Information Collection Request: Revision, OMB 0925-0001, Expiration Date 9/30/07. *Form Numbers:* PHS 398, 2590, 2271, 3734 and HHS 568. *Need and Use of Information Collection:* The application is used by applicants to request Federal assistance for research and research-related training. The other related forms are used for trainee appointment, final invention reporting, and to relinquish rights to a research grant. *Frequency of response:* Applicants may submit applications for published receipt dates. If awarded, annual progress is reported and trainees may be appointed or reappointed. *Affected Public:* Individuals or Households; Business or other for-profit; Not-for-profit institutions; Federal Government; and State, Local or Tribal Government. *Type of Respondents:* Adult scientific professionals. *The annual reporting burden is as follows: Estimated Number of Respondents:* 158,820; Estimated Number of Responses per Respondent: 1; *Average Burden Hours Per Response:* 15.8; and Estimated Total *Annual Burden Hours Requested:* 2,517,466. The estimated annualized cost to respondents is $88,058,547. *Request for Comments:* Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points:

(1)Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility;

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

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

(4)Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Ms. Mikia Currie, Division of Grants Policy, Office of Policy for Extramural Research Administration, NIH, Rockledge 1 Building, Room 3505, 6705 Rockledge Drive, Bethesda, MD 20892-7974, or call non-toll-free number 301-435-0941, or e-mail your request, including your address to: *curriem@od.nih.gov.* *Comments Due Date:* Comments regarding this information collection are best assured of having their full effect if received within 60-days of the date of this publication. Dated: July 16, 2007. Mikia Currie, OPERA, Office of Extramural Research, National Institutes of Health. [FR Doc. E7-14214 Filed 7-23-07; 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. Cytochrome P450 Inhibitors for Treatment of Cocaine-Induced Fetal Brain Injury *Description of Technology* : It is estimated that one percent of pregnant women use cocaine at some point in their pregnancies. In addition to increased risk for complications during pregnancy such as stillbirth, stroke, and low birth weight, cocaine appears to affect both short-term and long-term mental development. Animal studies indicate changes in brain development and behavior in response to prenatal cocaine exposure, and research has shown that children exposed to cocaine before birth are at risk of learning and behavioral problems. Children exposed to cocaine before birth are twice as likely to have significant delays in mental skills by age two. Treatment for pregnant women who use cocaine is typically directed to cocaine avoidance, but these treatments do not directly address the problem of cocaine-induced damage in the developing fetus, particularly in the fetal brain. Thus, there exists a critical need for drugs that can prevent or treat cocaine-induced damage to the fetal brain. The inventors have demonstrated that N-oxidative metabolism of cocaine causes oxidative stress to the endoplasmic reticulum, which ultimately results in cell cycle arrest and abnormal development of the fetal cerebral cortex. They have also shown that cytochrome P450 inhibitors can block the inhibition of cell proliferation by cocaine. This invention discloses methods of using cytochrome P450 inhibitors to treat or prevent cocaine-induced fetal brain injury, as well as methods for screening for inhibitory drugs to treat or prevent cocaine-induced fetal brain injury. *Applications:* Development of cytochrome P450-based therapeutics for fetal brain injury caused by cocaine exposure; Assay to screen for new drugs that prevent cocaine-induced fetal brain injury. *Development Status:* The inventors plan to test cytochrome P450 inhibitors in animal models. *Inventors:* Chun-Ting Lee and William Freed (NIDA). *Publication:* In preparation. *Patent Status:* U.S. Provisional Application No. 60/893,218 filed 06 Mar 2007 (HHS Reference No. E-025-2007/0-US-01). *Licensing Status:* This technology is available for exclusive, co-exclusive, or nonexclusive licensing. *Licensing Contact:* Tara L. Kirby, PhD; 301/435-4426; tarak@mail.nih.gov. *Collaborative Research Opportunity:* The Cellular Neurobiology Research Branch of the National Institute on Drug Abuse is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize the development of P450 inhibitors and related compounds for the prevention of cocaine-induced developmental brain damage Please contact John D. Hewes, PhD at 301-435-3121 or *hewesj@mail.nih.gov* for more information. Methods and Materials for Identifying Polymorphic Variants, Diagnosing Susceptibilities, and Treating Disease *Description of Technology:* This invention relates to materials and methods associated with polymorphic variants in two enzymes involved in folate-dependent and one-carbon metabolic pathways important in pregnancy-related complications and neural tube birth defects: MTHFD1 (5,10-methylenetetrahydrofolate dehydrogenase, 5,10-methylenetetrahydrofolate cyclohydrolase, 10-formyltetrahydrofolate synthase) and methylenetetrahydrofolate dehydrogenase (NADP + dependent) 1-like (MTHFD1L). These enzymes are extremely important in the promotion of DNA synthesis, a process that is critical for normal placental and fetal development. Recently, the inventors have discovered that a MTHFD1 polymorphism is also a maternal genetic risk factor for placental abruption, premature separation of a normally implanted placenta. This polymorphism may also be a risk factor for first and second trimester miscarriages. Diagnostic and therapeutic methods are provided in this invention involving the correlation of polymorphic variants in MTHFD1 and MTHFD1L and other genes with relative susceptibility for various pregnancy-related and other complications such as cancer, cardiovascular disease, developmental anomalies and psychiatric illnesses. Both nutrient status and genetic background are independent yet interacting risk factors for impaired folate metabolism. However, the mechanisms that lead to pathology or the mechanisms whereby folate prevents these disorders are unknown. Therefore, a diagnostic and therapeutic invention of this kind would significantly improve the detection and treatment of disorders associated with folate metabolism. *Inventors:* Lawrence C. Brody (NHGRI) *et al.* *Publications:* 1. A Parle-McDermott *et al.* MTHFD1 R653Q polymorphism is a maternal genetic risk factor for severe abruptio placentae. Am J Med Genet A. 2005 Feb 1;132(4):365-368. 2. A Parle-McDermott *et al.* A polymorphism in the *MTHFD1* gene increases a mother's risk of having an unexplained second trimester pregnancy loss. Mol Hum Reprod. 2005 Jul;11(7):477-480. 3. A Parle-McDermott *et al.* Confirmation of the R653Q polymorphism of the trifunctional C1-synthase enzyme as a maternal risk for neural tube defects in the Irish population. Eur J Hum Genet. 2006 Jun;14(6):768-772. 4. B Kempisty *et al.* MTHFD 1958G>A and MTR 2756A>G polymorphisms are associated with bipolar disorder and schizophrenia. Psychiatr Genet. 2007 Jun;17(3):177-181. *Patent Status:* International Application No. PCT/US2005/21288 filed 16 Jun 2005, which is published as WO 2007/001259 on 04 Jan 2007 (HHS Reference No. E-149-2005/0-PCT-01). *Licensing Status:* Available for exclusive or non-exclusive licensing. *Licensing Contact:* Tara L. Kirby, PhD; 301/435-4426; *tarak@mail.nih.gov* . *Collaborative Research Opportunity:* The National Human Genome Research Institute is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this technology. Please contact Claire Driscoll at 301-402-2537 or *cdriscol@mail.nih.gov* for more information. Dated: July 16, 2007. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E7-14204 Filed 7-23-07; 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. Rational HIV Therapeutic Design *Description of Technology:* This technology describes the structural nature of a highly conserved tyrosine-sulfate binding pocket on the HIV-1 gp120 envelope glycoprotein and the use of this information to design HIV-entry inhibitors that target it. The binding pocket was characterized by structural determinations of the N-terminus of CCR5 with gp120 as well as of the complex of 412d (a tyrosine-sulfated antibody) with gp120 and CD4. The N terminus of CCR5, like the 412d antibody, is tyrosine-sulfated. In spite of structural differences between these molecules, gp120 recognizes both tyrosine-sulfated molecules in similar ways, indicating that this specificity can be exploited in the design of HIV-entry inhibitors. *Applications:* HIV therapeutic design. *Inventors:* Peter D. Kwong et al. (NIAID). *Patent Status:* U.S. Provisional Application No. 60/923,498 filed 13 Apr 2007 (HHS Reference No. E-181-2007/0-US-01). *Licensing Contact:* Susan Ano, PhD; 301/435-5515; *anos@mail.nih.gov.* *Collaborative Research Opportunity:* The Vaccine Research Center of the National Institute of Allergy and Infectious Diseases as well as the Laboratory of Bioorganic Chemistry of the National Institute of Diabetes and Digestive and Kidney Diseases are seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize tyrosine-sulfated CCR5-based inhibitors of HIV-1 infection. Please contact Susan Ano for more information. Viral Entry or Replication Inhibitors *Description of Technology:* The Tec family of tyrosine kinases, consisting of five family members Tec, Btk, Itk, Rlk, and BMX, are key regulators of signaling pathways of T lymphocytes. Many existing antiviral therapies rely on inhibition of viral replication, which leads to emergence or selection of resistant viruses. The current technology provides an alternative method for prevention or treatment of viral infection through administration of a Tec tyrosine kinase inhibitor. Such inhibitors can be siRNA, small chemical compounds, antisense or antibody. The current technology describes the inhibition of Itk (also known as Emt and Tsk) and the resulting decrease in HIV infectivity, replication, and transcription for exemplary purposes. Importantly, these inhibitors do not affect the expression of HIV co-receptors CCR5, CXCR4, or CD4. The current technology could be used in combination with therapeutics that target virus replication. *Application:* Treatment of viral infection. *Development Status:* In vitro data available. *Inventors:* Julie Readinger et al. (NHGRI). *Patent Status:* U.S. Provisional Application No. 60/786,245 filed 29 Mar 2006 (HHS Reference No. E-151-2006/0-US-01); PCT Application No. PCT/US2007/007711 filed 29 Mar 2007 (HHS Reference No. E-151-2006/1-PCT-01). *Licensing Contact:* Susan Ano, Ph.D.; 301/435-5515; *anos@mail.nih.gov.* Dual Expression DNA Influenza Vaccine *Description of Technology:* The NIH is pleased to announce a single vector DNA vaccine against influenza as available for licensing. The single vector expresses both hemagglutinin

(HA)and matrix

(M)proteins, generating both humoral and cellular immune responses. The vaccine candidate completely protected mice against homologous virus challenge and significantly improved survival against heterologous virus challenge. A robust and reliable vaccine supply is widely recognized as critical for seasonal or pandemic influenza preparedness. The advantages offered by this vaccine make it an excellent candidate for further development. *Advantages:*

(1)DNA vaccines easy to produce and store;

(2)Vaccine candidate improved survival against heterologous virus challenge;

(3)No risk of reversion to pathogenic strain as with live-attenuated virus vaccines;

(4)Can be administered to immuno-compromised individuals, increasing potential market size;

(5)HA and M proteins encoded by single vector, ensuring uniform delivery of immunogen;

(6)More efficient to boost synergistic effects on both HA and M specific immune responses than a mixture of individual plasmids;

(7)M protein not subject to antigenic drift, which allows advanced manufacturing and overcomes the need for strain monitoring;

(8)DNA vaccines elicit cellular immune response, essential for efficient virus clearance. *Application:* Influenza vaccine. *Inventors:* Zhiping Ye *et al.* (CBER/FDA). *Patent Status:* U.S. Provisional Application No. 60/786,747 filed 27 Mar 2006 (HHS Reference No. E-300-2005/0-US-01); PCT Application No. PCT/US2007/007529 filed 27 Mar 2007 (HHS Reference No. E-300-2005/1-PCT-01). *Licensing Contact:* Susan Ano, Ph.D.; 301/435-5515; *anos@mail.nih.gov.* *Collaborative Research Opportunity:* The CBER/FDA Division of Viral Products is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize the HA/M single vector DNA vaccine. Please contact Zhiping Ye at 301-435-5197 or *zhiping.ye@fda.hhs.gov* for more information. Peptide Mimotope Candidates for Otitis Media Vaccine *Description of Technology:* This technology describes peptide mimotopes of lipooligosaccharides

(LOS)from nontypeable *Haemophilus influenzae*

(NTHi)and *Moraxella catarrhalis* that are suitable for developing novel vaccines against the respective pathogens, for which there are currently no licensed vaccines. The mimotopes not only immunologically mimic LOSs from NTHi and *M. catarrhalis* but will also bind to antibodies specific for the respective LOS. NTHi and *M. catarrhalis* are common pathogens that cause otitis media in children and lower respiratory tract infections in adults. The effectiveness of a vaccine could be increased by substitution of a LOS epitope with a peptide mimic. Preliminary experiments have shown that some of the mimic peptides conjugated to a carrier were as effective as their respective LOS-based vaccine in stimulating a humoral immune response in rabbits. A single consensus amino acid sequence was identified for *M. catarrhalis,* while four such sequences were identified for NTHi. Thus, the identified peptides are promising candidates for developing novel vaccines for NTHi or *M. catarrhalis.* *Applications:* Otitis media vaccine. *Development Status:* In vivo data available. *Inventor:* Xin-Xing Gu (NIDCD). *Patent Status:* U.S. Patent Application No. 11/187,419 filed 22 Jul 2005 (HHS Reference No. E-344-2002/0-US-03). *Licensing Contact:* Susan Ano, Ph.D.; 301/435-5515; *anos@mail.nih.gov.* *Collaborative Research Opportunity:* The NIDCD Vaccine Research Section is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize Peptide vaccines derived from LOS of NTHi or *M. catarrhalis.* Please contact Marianne Lynch, a technology development specialist, at 301-594-4094 or *lynchm2@mail.nih.gov* for more information. Dated: July 17, 2007. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E7-14205 Filed 7-23-07; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health State-of-the-Science Conference: Prevention of Fecal and Urinary Incontinence in Adults; Notice Notice is hereby given of the National Institutes of Health

(NIH)“State-of-the-Science Conference: Prevention of Fecal and Urinary Incontinence in Adults” to be held December 10-12, 2007, in the NIH Natcher Conference Center, 45 Center Drive, Bethesda, Maryland 20892. The conference will begin at 8:30 a.m. on December 10 and 11, and at 9 a.m. on December 12, and will be open to the public. Fecal and urinary incontinence—the inability to control bowel movements or urination, respectively—are conditions with ramifications that extend well beyond their physical manifestations. Many people find themselves withdrawing from their social lives and attempting to hide the problem from their families, friends, and even their doctors. The embarrassing nature of these conditions poses a significant barrier to seeking professional treatment, resulting in a large number of unreported, untreated individuals. Therefore, it is difficult to determine the accurate prevalence of these conditions, as well as any associated medical history trends. Incontinence is more likely to affect the aging population, although it is not considered a normal consequence of aging. As baby boomers approach their 60s, the incidence and public health burden of incontinence are likely to increase. Fecal incontinence is a serious and embarrassing problem that affects up to 5 percent of the general population and up to 39 percent of nursing home residents. It affects people of all ages but is more common in women and the elderly. Bowel function is controlled by three factors: rectal sensation, rectal storage capacity, and anal sphincter pressure. If any of these are compromised, fecal incontinence can occur. This condition can have many causes, including constipation, diarrhea, complicated childbirth, muscular or nerve damage, reduced storage capacity due to scarring or irritation, or pelvic dysfunction. Although urinary incontinence can affect people at all stages of life, it has been estimated that urinary incontinence affects 38 percent of women and 17 percent of men 60 years of age and older. Urinary incontinence can occur if muscles in the wall of the bladder suddenly contract or if muscles surrounding the urethra suddenly relax. Women who have undergone childbirth are the most commonly associated at-risk population for urinary incontinence. Pregnancy and delivery can weaken pelvic muscles, and reduced levels of the hormone estrogen following menopause can cause reduced muscle tone around the urethra, increasing the chance of leakage. Additionally, neurologic injury, birth defects, strokes, multiple sclerosis, and physical problems associated with aging have been reported to contribute. Because incontinence is likely widely underdiagnosed and underreported, it has been difficult to identify both at-risk and affected populations. Also, because the biological mechanisms that cause both fecal and urinary incontinence are not well understood, it has been difficult to develop robust prevention and management strategies. Toward that end, the National Institute of Diabetes and Digestive and Kidney Diseases and the Office of Medical Applications of Research of the NIH will convene a State-of-the-Science Conference from December 10 to 12, 2007, to assess the available scientific evidence relevant to the following questions: • What are the prevalence, incidence, and natural history of fecal and urinary incontinence in the community and long-term care settings? • What is the burden of illness and impact of fecal and urinary incontinence on the individual and society? • What are the risk factors for fecal and urinary incontinence? • What can be done to prevent fecal and urinary incontinence? • What are the strategies to improve the identification of persons at risk and patients who have fecal and urinary incontinence? • What are the research priorities in reducing the burden of illness in these conditions? An impartial, independent panel will be charged with reviewing the available published literature in advance of the conference, including a systematic literature review commissioned through the Agency for Healthcare Research and Quality. The first day and a half of the conference will consist of presentations by expert researchers and practitioners and open public discussions. On Wednesday, December 12, the panel will present a statement of its collective assessment of the evidence to answer each of the questions above. The panel will also hold a press conference to address questions from the media. The draft statement will be published online later that day, and the final version will be released approximately six weeks later. The primary sponsors of this meeting are the National Institute of Diabetes and Digestive and Kidney Diseases and the NIH Office of Medical Applications of Research. Advance information about the conference and conference registration materials may be obtained from American Institutes for Research of Silver Spring, Maryland, by calling 888-644-2667, or by sending e-mail to *consensus@mail.nih.gov.* American Institutes for Research's mailing address is 10720 Columbia Pike, Silver Spring, MD 20901. Registration information is also available on the NIH Consensus Development Program Web site at *http://consensus.nih.gov.* Please Note: The NIH has instituted 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 12, 2007. Raynard S. Kington, Deputy Director, National Institutes of Health. [FR Doc. E7-14208 Filed 7-23-07; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Complementary & Alternative Medicines; 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 the National Advsiory Council for Complementary and Alternate Medicine (NACCAM) meeting. The meetings 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. A portion of 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/or contract proposals and the discussion could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications and/or contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. ` *Name of Committee:* National Advisory Council for Complementary and Alternative Medicine. *Date:* September 5, 2007. *Time:* 8 a.m. to 12 p.m. *Agenda:* To review and evaluate grant applications and/or proposals. *Open:* 1 p.m. to 4:30 p.m. *Agenda:* Opening remarks by the Acting Director of National Center for Complementary and Alternative Medicine, presentation of a new research alternative, and other business of the Council. *Place:* National Institutes of Health, Neuroscience Building, 6001 Executive Boulevard, Conference Rooms C & D, Bethesda, MD 20882. *Contact Person:* Martin H. Goldrosen, Executive Secretary, National Center for Complementary and Alternative Medicine, National Institutes of Health, 6707 Democracy Blvd., Suite 401, Bethesda, MD 20892,

(301)594-2014. The public comments session is scheduled from 4-4:30 p.m., but could change depending on the actual time spent on each agenda item. Each speaker will be permitted 5 minutes for their presentation. Interested individuals and representatives of organizations are requested to notify Dr. Martin H. Goldrosen, National Center for Complementary and Alternative Medicine, NIH, 6707 Democracy Boulevard, Suite 401, Bethesda, Maryland, 20892, 301-594-2014, Fax: 301-480-9970. Letters of intent to present comments, along with a brief description of the organization represented, should be received no later than 5 p.m. on September 3, 2007. Only one representative of an organization may present oral comments. Any person attending the meeting who does not request an opportunity to speak in advance of the meeting may be considered for oral presentation, if time permits, and at the discretion of the Chairperson. In addition, written comments may be submitted to Dr. Martin H. Goldrosen at the address listed above up to ten calendar days (September 15, 2007) following the meeting. Copies of the meeting agenda and the roster of members will be furnished upon request by contacting Dr. Martin H. Goldrosen, Executive Secretary, NACCAM, National Center for Complementary and Alternative Medicine, National Institutes of Health, 6707 Democracy Boulevard, Suite 401, Bethesda, Maryland 20892, 301-594-2014, Fax 301-480-9970, or via e-mail at *naccames@mail.nih.gov.* In the interest of security, NIH has instituted stringent procedures for entrance into the building by nongovernment employees. Persons without a government I.D. will need to show a photo I.D. and sign in at the security desk upon entering the building. Dated: July 17, 2007. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 07-3587 Filed 7-23-07; 8:45 am]

Connectionstraces to 6

Traces to 6 documents

U.S. Code