Notices. Notice of proposed child abuse and neglect research priorities for Fiscal Years 2006-2008 SUMMARY: The Children's Bureau (CB) within the Administration on Children, Youth and Families (ACYF) announces the proposed priorities for research on the causes, prevention, assessment, identification, treatment, cultural and socio-economic distinctions, and the consequences of child abuse and neglect
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/register/2006/02/03/06-1021A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4184-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Children's Bureau Proposed Research Priorities for Fiscal Years 2006-2008. AGENCY: Administration on Children, Youth and Families (ACYF), Administration for Children and Families (ACF), HHS. ACTION: Notice of proposed child abuse and neglect research priorities for Fiscal Years 2006-2008 SUMMARY: The Children's Bureau
(CB)within the Administration on Children, Youth and Families
(ACYF)announces the proposed priorities for research on the causes, prevention, assessment, identification, treatment, cultural and socio-economic distinctions, and the consequences of child abuse and neglect. Section 104(a)(4) of the Child Abuse Prevention and Treatment Act (CAPTA), as amended by the Keeping Children and Families Safe Act of 2003, Public Law (Pub. L.). 108-36, requires the Secretary of the Department of Health and Human Services
(HHS)to publish proposed priorities for research activities for public comment and to maintain an official record of such public comment. The proposed priorities are being announced for the two-year period required by CAPTA. Because the amount of Federal funds available for discretionary activities in Fiscal Years 2006-2008 is expected to be limited, respondents are encouraged to recommend how the proposed issues should be prioritized. The actual solicitation of grant applications will be posted electronically each fiscal year and will be available online through *http://www.Grants.gov.* Solicitations for contracts will be announced, at later dates, online at FedBizOps. (FY 05 was the last year that CB discretionary grants were published in the **Federal Register** .) No proposals, concept papers or other forms of application should be submitted at this time. No acknowledgement will be made of the comments submitted in response to this notice, but all comments received by the deadline will be reviewed and given thoughtful consideration in the preparation of the final funding priorities for the announcements. DATES: In order to be considered, comments must be received no later than April 4, 2006. SUPPLEMENTARY INFORMATION: I. Background As noted above, Section 104(a)(4) of CAPTA requires the Secretary to publish proposed priorities for research activities for public comment every two years. In response to this legislative mandate, CB has undertaken a review of the current legislative language, the results of the CAPTA funded research since the last CAPTA announcement of research priority areas in 1997, findings from other relevant research, and input from the field. Based on this review, this notice of proposed research is being disseminated for comment. The FY 2005 budget appropriated $31,640,000 for child abuse discretionary activities to support efforts designed to assist and enhance national, State and local efforts to prevent, identify and treat child abuse and neglect. The program funds projects to: Compile, publish and disseminate training materials; provide technical assistance; and demonstrate and evaluate improved methods and procedures to prevent and treat child abuse and neglect. Under discretionary funds, CB will continue to fund the following clearinghouse and technical assistance activities: • The National Clearinghouse on Child Abuse and Neglect Information; • The National Resource Center on Child Protective Services; and • The National Child Abuse and Neglect Data System (NCANDS) technical assistance and technical support program. In addition, the child abuse discretionary activities account funds a number of research and demonstration grants and contracts. The fourth National Incidence Study of Child Abuse and Neglect (NIS-4), is a Congressionally mandated, periodic research effort to assess the incidence of child abuse and neglect in the United States. Also, consistent with the legislation's preference for longitudinal research efforts related to child maltreatment, CB discretionary funds continue to support the Consortium for Longitudinal Studies of Child Maltreatment (LONGSCAN). For those members of the public interested in responding to this announcement, information on previous and continuing projects supported by CB are available through the following websites: • The National Clearinghouse on Child Abuse and Neglect Information ( *http://nccanch.acf.hhs.gov* ); • Children's Bureau Reports/Publications ( *http://www.acf.dhhs.gov/programs/cb/publications/index.htm* ); • LONGSCAN ( *http://www.iprc.unc.edu/longscan* ); • NIH Child Abuse and Neglect Working Group Neglect Consortium ( *http://obssr.od.nih.gov* ); and • National Center for Children Exposed to Violence ( *http://www.nccev.org* ). II. Proposed Child Abuse and Neglect Research Priorities for Fiscal Years 2006-2008 A. Legislative Topics A number of research topics are suggested in the 2003 reauthorization of CAPTA, Section 104. The legislation states that the Secretary shall, along with other Federal agencies and recognized experts in the field, carry out a continuing interdisciplinary program of research, including longitudinal research, that is designed to provide information needed to better protect children from abuse or neglect and to improve the well-being of abused or neglected children, with at least a portion of such research being field initiated. Suggested research includes: • The nature and scope of child abuse and neglect; • The causes, prevention, assessment, identification, treatment, cultural and socio-economic distinctions and consequences of child abuse and neglect, including the effects of abuse and neglect on a child's development and the identification of successful early intervention services or other services that are needed; • Appropriate, effective and culturally sensitive investigative, administrative and judicial systems, including multidisciplinary, coordinated decision making procedures with respect to cases of child abuse; • The evaluation and dissemination of best practices consistent with the goals of achieving improvements in child protective services systems of the States in accordance with CAPTA, Section 106(a), Grants to States for Child Abuse and Neglect Prevention and Treatment Programs, paragraphs
(1)through (14), which include: i. The intake, assessment, screening and investigation of reports of abuse and neglect; ii. Creating and improving the use of multidisciplinary teams and interagency protocol to enhance investigation, and improving legal preparation and representation; iii. Case management, including ongoing case monitoring and delivery of services and treatment provided to children and their families; iv. Enhancing the general child protective system by developing, improving and implementing risk and safety assessment tools and protocols; v. Developing and updating systems of technology that support the program and track reports of child abuse and neglect from intake through final disposition and allow interstate and intrastate information exchange; vi. Developing, strengthening and facilitating training; vii. Improving the skills, qualifications and availability of individuals providing services to children and families, and the supervisors of such individuals, through the child protection system, including improvements in the recruitment and retention of caseworkers; viii. Developing and facilitating training protocols for individuals mandated to report child abuse or neglect; ix. Developing and facilitating research-based strategies for training individuals mandated to report child abuse or neglect; x. Developing, implementing or operating programs to assist in obtaining or coordinating necessary services for families of disabled infants with life-threatening conditions; xi. Developing and delivering information to improve public education relating to the role and responsibilities of the child protection system and the nature and basis for reporting suspected incidents of child abuse and neglect; xii. Developing and enhancing the capacity of community-based programs to integrate shared leadership strategies between parents and professionals to prevent and treat child abuse and neglect at the neighborhood level; xiii. Supporting and enhancing interagency collaboration between the child protection system and the juvenile justice system for improved delivery of services and treatment, including methods for continuity of treatment plans and services as children transition between systems; or xiv. Supporting and enhancing collaboration among public health agencies, the child protection system and private community-based programs to provide child abuse and neglect prevention and treatment services (including linkages with education systems) and to address the health needs, including mental health needs, of children identified as abused or neglected, including supporting prompt, comprehensive health and developmental evaluations for children who are the subject of substantiated child maltreatment reports. • Effective approaches to interagency collaboration between the child protection system and the juvenile justice system that improve the delivery of services and treatment, including methods for continuity of treatment plans and services as children transition between systems; • An evaluation of the redundancies and gaps in services in the field of child abuse and neglect prevention in order to make better use of resources; or • The nature, scope and practice of voluntary relinquishment for foster care or State guardianship of low-income children who need health services, including mental health services. B. Other Topics *Prevention Practices:* CB is interested in research that builds on existing knowledge about child abuse and neglect prevention. CB initiated the Emerging Practices in the Prevention of Child Abuse and Neglect project as a collaboration between the agency and the professional community to describe the current landscape of prevention programs and generate new information about effective and innovative approaches to the prevention of child maltreatment. Through a national nomination process, several strategies and features of child abuse prevention programs were identified as holding promise for reducing the incidence of child maltreatment. Next, a grant competition to fund replications of effective prevention programs was held. Funds were awarded to eight sites nationwide to replicate the University of Maryland's “Family Connections” project. While this work is contributing to the body of knowledge about the type and range of problems in the U.S. for the prevention of maltreatment, it is clear that much more can and must be learned about the effectiveness of prevention programs in terms of what works and for whom. Research interests may include: The efficacy of prevention in the field of child maltreatment; rigorous study on all the major prevention models and strategies; and integrating child abuse and neglect research into prevention practices. *Child Protection Systems:* CB is interested in research that examines effective State-level strategies employed to improve child protection systems. Questions may include: the degree to which changes in *Child Protection Systems*
(CPS)systems policy and practice are tied to better outcomes; determining the variations in local agencies that result in different outcomes; and whether or not child safety and well-being are improved by privatizing part or all of the child welfare system. Other research interests may include: Effective responses for children at risk of being harmed; barriers to consistency in CPS operations, such as differences in the level of resources; lack of clear laws and policy and the competing desire for local autonomy in government functions; the means by which CPS agencies try to understand the standards of the community they serve through outreach to additional panels and review teams (fatality review team, citizen review panels, external case reviews); and collaborations between CPS and other agencies. In addition, CB continues to be interested in building on previous research to explore over-representation of minorities in the child welfare system, particularly research to identify and disseminate lessons learned from promising practices that have been effective in reducing the rates of over-representation of children of color in the child welfare system. *Services:* CB is interested in research focused on the assessment of service needs and services provided. Research questions may include: What services are children and families receiving; to what degree are services responsive to the needs of the target population; and what are the outcomes that result from various services. Other research may focus on case planning and intervention such as examining the development and implementation of comprehensive family assessment, safety planning, engaging families and monitoring risk assessment over the life of CPS cases, as well as increasing knowledge of parent and child engaging in the case planning process. The findings from the initial Child and Family Service Reviews
(CFSR)of all 50 States, the District of Columbia and Puerto Rico, identify strengths and needs within State programs, as well as areas where technical assistance can lead to program improvements. CB encourages research on areas in which States were found to be weak based on the CFSRs. State performance on identifying and responding to children's mental health issues, in particular, was found to be one of the weakest in the CFSRs. Areas of interest for research may examine CPS procedures for identifying and responding to children's mental health issues as well as the prevalence, type and severity of mental health problems among children identified in State child welfare systems. In addition, findings from the National Survey of Child and Adolescent Well-Being (NSCAW) show that high rates of mental health problems among parents, coupled with low rates of identification and referral, is a serious issue. CB is interested in research that examines mental health services to parents. *Program Evaluation of Priority Area Initiatives (or Evaluation of Programs Addressing Administration Priorities):* The current Administration has focused funding in areas of healthy marriage promotion, fatherhood initiatives, community and faith-based organizations and youth development in ensuring the healthy development of children. CB is interested in research to evaluate programs employing these strategies to prevent child abuse and neglect. Research topics may include the evaluation of the effectiveness of these programs as well as the dissemination of promising practices. *Secondary Data Analysis:* CB encourages the utilization of existing data sources particularly the use of service data through the National Child Abuse and Neglect Data System (NCANDS). CB is interested in secondary data analyses using NCANDS focusing on service utilization, recurrence and perpetrators. *Service utilization:* While not all States provide complete service data to NCANDS, for those States that do provide complete service data, the following areas could be examined: The services that are most often provided to victims of maltreatment; differences in service patterns that exist between children who are first-time victims and children who are repeat victims; differences in service patterns that exist between child victims who remain in their homes and those who are removed; and the variations in service patterns within States according to county characteristics. *Recurrence:* To date, recurrence has largely been examined for six-month periods using NCANDS data. The Office of the Assistant Secretary for Planning and Evaluation undertook a longitudinal analysis of NCANDS data examining repeated CPS involvement. Using a multiyear dataset of 1,396,998 children, this research examined the proportion of reported children who re-reported, the proportion of child victims who had a recurrence of maltreatment and the factors associated with these repeated events. The findings showed that re-reporting was relatively common—about one-third of children had at least one repeated report of maltreatment within a five-year period. For the most part, the same factors were related to both re-reporting of all reported children and recurrence among victims of maltreatment. Findings were also similar when analyses examined only the presence of a single subsequent event or the number and type of multiple subsequent events. Both re-reporting and recurrence occurred more frequently among younger children. Re-reporting and recurrence were more likely to occur in a short time following the initial maltreatment report, usually within a few months. Most children who experienced more than one re-report or re-victimization experienced these events within a short time after the initial event. Areas for further research might examine: Factors that are predictive of a second investigation; report sources that are the most likely to be associated with a second investigation; services that decrease subsequent investigation; and services that decrease subsequent victimization. *Perpetrators:* CB continues to be interested in perpetrators, with the notion that understanding who this group is and what their characteristics are, can help to inform more effective intervention and prevention efforts. The Office of the Assistant Secretary for Planning and Evaluation undertook an analysis of NCANDS data examining some of these questions. The analysis focused on male perpetrators of child maltreatment and identifies clear subgroups of male perpetrators. The findings suggest that interventions of all types may need to be more highly differentiated for these different groups. Follow-up of interest includes research to gain a clearer picture of how the various categories of perpetrators fit within households to provide insights into the service and recidivism outcomes. C. Field Initiated Research on Child Abuse and Neglect The generation of new knowledge for understanding critical issues in child abuse and neglect improves prevention, identification, assessment and treatment. Research areas to be addressed may be those that will expand the current knowledge base, build on prior research, contribute to practice enhancements, inform policy, improve science and provide insights into new approaches to the assessment, prevention, intervention and treatment of child maltreatment (i.e., physical abuse, sexual abuse, emotional maltreatment or neglect) on any of the topics listed in
(A)Legislative Topics,
(B)Other Topics, above, or any other child maltreatment topic. In addition to the topics cited above, practitioners and researchers are encouraged to propose other relevant subjects for research topics in child abuse and neglect. Joan E. Ohl, Commissioner, Administration on Children, Youth and Families. [FR Doc. E6-1480 Filed 2-2-06; 8:45 am] BILLING CODE 4184-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005P-0023] Determination That TEQUIN (Gatifloxacin) Injection, 10 Milligrams per Milliliter (200 Milligrams), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)has determined that TEQUIN (gatifloxacin) injection, 10 milligrams
(mg)per milliliter
(mL)(200 mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for gatifloxacin injection, 10 mg/mL (200 mg). FOR FURTHER INFORMATION CONTACT: Elaine Tseng, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (the 1984 amendments) (Pub. L. 98-417), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA sponsors must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is typically a version of the drug that was previously approved. Sponsors of ANDAs do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The only clinical data required in an ANDA are data to show that the drug that is the subject of the ANDA is bioequivalent to the listed drug. The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is generally known as the “Orange Book.” Under FDA regulations, drugs are withdrawn from the list if the agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). Under 21 CFR 314.161(a)(1), the agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness before an ANDA that refers to that listed drug may be approved. FDA may not approve an ANDA that does not refer to a listed drug. TEQUIN (gatifloxacin) injection, 10 mg/mL (200 mg), is the subject of approved NDA 21-062 held by Bristol-Myers Squibb. TEQUIN (gatifloxacin) injection, 10 mg/mL (200 mg), is an antibiotic used to treat adults with lung, sinus, or urinary tract infections. FDA approved the NDA for TEQUIN (gatifloxacin) injection, 10 mg/mL (200 mg) and 10 mg/mL (400 mg), on December 17, 1999. On January 27, 2003, FDA received revised product labeling relating to several approved supplements for TEQUIN (gatifloxacin). This revised labeling deleted references to TEQUIN (gatifloxacin) injection, 10 mg/mL (200 mg), indicating that this product was no longer being marketed. Therefore, it was moved from the prescription drug product list to the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. Apotex Corp., submitted a citizen petition dated January 13, 2005 (Docket No. 2005P-0023/CP1), under 21 CFR 10.30, requesting that the agency determine whether TEQUIN (gatifloxacin) injection, 10 mg/mL (200 mg), was withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition and reviewing agency records, FDA has determined that TEQUIN (gatifloxacin) injection, 10 mg/mL (200 mg), approved under NDA 21-062, was not withdrawn from sale for reasons of safety or effectiveness. The petitioner identified no data or other information suggesting that TEQUIN (gatifloxacin) injection, 10 mg/mL (200 mg), was withdrawn from sale as a result of safety or effectiveness concerns. FDA's independent evaluation of relevant literature and data has not uncovered anything that would indicate that this product was withdrawn for reasons of safety or effectiveness. Accordingly, the agency will continue to list TEQUIN (gatifloxacin) injection, 10 mg/mL (200 mg), in the “Discontinued Drug Product List” section of the Orange Book. ANDAs that refer to TEQUIN (gatifloxacin) injection, 10 mg/mL (200 mg), may be approved by the agency. Dated: January 27, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-1475 Filed 2-2-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004E-0389] Determination of Regulatory Review Period for Purposes of Patent Extension; SURPASS AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)has determined the regulatory review period for SURPASS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that animal drug product. ADDRESSES: Submit written comments and petitions to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . FOR FURTHER INFORMATION CONTACT: Claudia V. Grillo, Office of Regulatory Policy (HFD-013), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 240-453-6681. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For animal drug products, the testing phase begins on the earlier date when either a major environmental effects test was initiated for the drug or when an exemption under section 512(j) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b(j)) became effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the animal drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for an animal drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(4)(B). FDA recently approved for marketing the animal drug product SURPASS (diclofenac sodium). SURPASS is indicated for the control of pain and inflammation associated with osteoarthritis in tarsal, carpal, metacarpophalangeal, metatarsophalangeal, and proximal interphalangeal (hock, knee, fetlock, and pastern) joints in horses. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for SURPASS (U.S. Patent No. 4,937,078) from Mezei Associates, Ltd., and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated April 8, 2005, FDA advised the Patent and Trademark Office that this animal drug product had undergone a regulatory review period and that the approval of SURPASS represented the first permitted commercial marketing or use of the product. Thereafter, the Patent and Trademark Office requested that FDA determine the product's regulatory review period. FDA has determined that the applicable regulatory review period for SURPASS is 2,262 days. Of this time, 1,028 days occurred during the testing phase of the regulatory review period, while 1,234 days occurred during the approval phase. These periods of time were derived from the following dates: 1. *The date an exemption under subsection 512(j) of the act became effective* : March 6, 1998. The applicant claims January 11, 1999, as the date the investigational new animal drug application
(INAD)became effective. However, FDA records indicate that the date of FDA's letter assigning a number to the INAD was March 6, 1998, which is considered to be the effective date for the INAD. 2. *The date the application was initially submitted with respect to the animal drug product under section 512(b) of the act* : December 27, 2000. The applicant claims January 2, 2001, as the date the new animal drug application
(NADA)for SURPASS (NADA 141-186) was initially submitted. However, a review of FDA records reveals that the date of FDA's official acknowledgement letter assigning a number to NADA 141-186 was December 27, 2000, which is considered to be the initially submitted date for NADA 141-186. 3. *The date the application was approved* : May 13, 2004. FDA has verified the applicant's claim that NADA 141-186 was approved on May 13, 2004. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,590 days of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments and ask for a redetermination by April 4, 2006. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by August 2, 2006. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: January 5, 2006. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E6-1434 Filed 2-2-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2003E-0407] Determination of Regulatory Review Period for Purposes of Patent Extension; CYPHER AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)has determined the regulatory review period for CYPHER and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that medical device. ADDRESSES: Submit written comments and petitions to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . FOR FURTHER INFORMATION CONTACT: Claudia V. Grillo, Office of Regulatory Policy (HFD-013), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 240-453-6681. SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For medical devices, the testing phase begins with a clinical investigation of the device and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a medical device will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(3)(B). FDA recently approved for marketing the medical device CYPHER. CYPHER is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete de novo lesions of the length ≤ 30 mm in native coronary arteries with a reference vessel diameter of ≥ 2.5 to ≤ 3.5 mm. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for CYPHER (U.S. Patent No. 5,563,146) from Wyeth, and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated June 24, 2004, FDA advised the Patent and Trademark Office that this medical device had undergone a regulatory review period and that the approval of CYPHER represented the first permitted commercial marketing or use of the product. Thereafter, the Patent and Trademark Office requested that FDA determine the product's regulatory review period. FDA has determined that the applicable regulatory review period for CYPHER is 814 days. Of this time, 513 days occurred during the testing phase of the regulatory review period, while 301 days occurred during the approval phase. These periods of time were derived from the following dates: 1. *The date an exemption under section 520(g) of the Federal Food, Drug, and Cosmetic Act (the act) involving this device became effective* : February 1, 2001. FDA has verified the applicant's claim that the date the investigational device exemption
(IDE)required under section 520(g) of the act (21 U.S.C. 360j(g)) for human tests to begin became effective February 1, 2001. 2. *The date the application was initially submitted with respect to the device under section 515 of the act (21 U.S.C. 360e)* : June 28, 2002. FDA has verified the applicant's claim that the premarket approval application
(PMA)for CYPHER (PMA P020023) was initially submitted June 28, 2002. 3. *The date the application was approved* : April 24, 2003. FDA has verified the applicant's claim that PMA P020023 was approved on April 24, 2003. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 557 days of patent term extension. Anyone with knowledge that any of the dates as published is incorrect may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments and ask for a redetermination by April 4, 2006. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by August 2, 2006. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: January 6, 2006. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E6-1436 Filed 1-2-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D-0017] Human Subject Protection—Information for Institutional Review Boards, Clinical Investigators, and Sponsors; Rescission, Reissuance, and Development of Food and Drug Administration Guidance Documents; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing an initiative, the Information Sheet Guidance Initiative, to update its process for developing, issuing, and making available guidances intended for institutional review boards (IRBs), clinical investigators, and sponsors. Known as “Information Sheets,” these guidances have provided recommendations for IRBs, clinical investigators, and sponsors to help them fulfill their responsibilities to protect human subjects who participate in research regulated by FDA since the early 1980s. The Information Sheet Guidance Initiative is intended to provide updated information and to issue the Information Sheets in accordance with FDA's good guidance practices (GGPs). As part of the initiative, which will be ongoing, the agency plans to rescind Information Sheets that are obsolete, revise and reissue Information Sheet Guidances that address current issues, and develop new Information Sheet Guidances as needed. The agency is also announcing the availability of five revised Information Sheet Guidances. DATES: Submit written or electronic comments on the Information Sheet Guidance Initiative or the Information Sheet Guidances by April 4, 2006. General comments on agency guidance documents are welcome at any time. ADDRESSES: Copies of the Information Sheets are available on the Internet at *http://www.fda.gov/oc/gcp/guidance.html* . Submit written requests for single copies of the Information Sheet Guidances to the Office of Training and Communications (HFD-240), Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the 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* . See the SUPPLEMENTARY INFORMATION section of this document for electronic access to the guidance documents. FOR FURTHER INFORMATION CONTACT: Bonnie M. Lee, Good Clinical Practice Program (HF-34), Food and Drug Administration, 5600 Fishers Lane, Rockville MD 20857, 301-827-3340. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the Information Sheet Guidance Initiative, which will update the current process for developing, issuing, and making available Information Sheets intended for IRBs, clinical investigators, and sponsors. Following issuance of human subject protection regulations by the Department of Health, Education, and Welfare and FDA in the late 1970s, IRBs frequently contacted FDA for advice on the best ways to achieve compliance with the new rules. In response, FDA issued informal guidance to answer the IRBs' specific questions. In 1984, FDA consolidated the informal guidance into a series of documents known as FDA's “Information Sheets for Institutional Review Boards and Clinical Investigators.” These Information Sheets were revised in 1995 and updated in 1998 to reflect new contact information. They were also edited to make them user friendly. The Information Sheets have provided answers to frequently asked questions about human subject protection, informed consent, review of research, and related topics. The Information Sheets are intended to help IRBs, clinical investigators, and sponsors ensure that the rights and welfare of human research subjects are protected. In 1997, the Food and Drug Administration Modernization Act required the agency to codify its GGPs policy. The GGP final rule, issued in 2000 (§ 10.115 (21 CFR 10.115)), requires that the agency make its guidance development and issuance procedures consistent and transparent. According to § 10.115, among other things, all FDA policy documents must be called guidance, and all agency guidance must be developed and issued according to the requirements in § 10.115. The Information Sheets are being converted to “Information Sheet Guidance” and are being issued in accordance with GGPs. II. Process The process of rescinding, revising, and reissuing all of the existing Information Sheets (there are approximately 40) may take several years to complete. The agency plans to make the process as transparent as possible. Therefore, FDA advises users to periodically check the agency's Information Sheet Web page at *http://www.fda.gov/oc/gcp/guidance.html* , throughout this time period. As guidances are revised and reissued and as new guidances are developed, they will be made available according to the GGP process and on this Web site. III. Guidances Being Made Available With This Notice The agency is announcing the availability of the following five Information Sheet Guidances that have been revised. These five Information Sheet Guidances replace the Information Sheets of the same titles (unless otherwise indicated) published in 1998. • “FDA Inspections of Clinical Investigators” (previously entitled “FDA Clinical Investigator Inspections”): This guidance is intended to provide information about FDA's inspections of clinical investigators conducted under FDA's Bioresearch Monitoring Program. • “FDA Institutional Review Board Inspections”: This guidance is intended to provide information about FDA's inspections of IRBs conducted under FDA's Bioresearch Monitoring Program. • “Waiver of IRB Requirements for Drug and Biologic Studies” (previously entitled “Waiver of IRB Requirements”): This guidance is intended to provide information about sponsor and sponsor-investigator requests for waivers of IRB requirements for drug and biologic studies. • “Significant Risk and Nonsignificant Risk Medical Device Studies”: This guidance is intended to provide advice to sponsors, clinical investigators, and IRBs on how to determine the differences between significant risk and nonsignificant risk medical device studies. • “Frequently Asked Questions About Medical Devices” (previously entitled “Medical Devices; Frequently Asked Questions about IRB Review of Medical Devices; Emergency Use of Unapproved Medical Devices”): This guidance is intended to assist sponsors, clinical investigators, and IRBs by answering common questions FDA receives concerning medical devices. These Information Sheet Guidances are level 2 guidances according to FDA's GGPs regulation. FDA is implementing the guidances immediately without prior public comment because they contain only minor revisions to reflect current policy and/or are consistent with policy interpretations of the Department of Health and Human Service's Office for Human Research Protections. These Information Sheet Guidances represent the agency's current thinking on topics concerned with human subject protection. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. IV. Comments As with all FDA's guidances, the public is encouraged to submit written or electronic comments pertinent to the Information Sheet Guidances or suggest topics for new Information Sheet Guidance. Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments on these Information Sheet Guidances. 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. The guidances and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. V. Electronic Access Persons with access to the Internet may obtain the documents at *http://www.fda.gov/oc/gcp/guidance.html* . Dated: January 24, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-1476 Filed 2-2-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D-0044] Draft Guidance for Industry on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing the availability of a draft guidance for industry entitled “Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims.” The draft guidance was prepared by the Office of New Drugs and the Office of Medical Policy in the Center for Drug Evaluation and Research
(CDER)in cooperation with the Center for Biologics Evaluation and Research
(CBER)and the Center for Devices and Radiological Health
(CDRH)at FDA. This document provides guidance to industry on the measurement of patient-reported outcomes
(PROs)in studies to support medical product claims in approved labeling. The draft guidance describes how FDA evaluates PRO instruments used as effectiveness endpoints in clinical trials. It also describes our current thinking on how sponsors can develop and use PRO instruments to support claims in approved product labeling. By explicitly addressing the review issues identified in this guidance, sponsors can increase the efficiency of their endpoint discussions with FDA during the product development process, streamline FDA's review of PRO endpoint adequacy, and provide optimal information about the patient's perspective of treatment benefit at the time of product approval. DATES: Submit written or electronic comments on the draft guidance by April 4, 2006. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857; or the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. The guidance can also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Laurie B. Burke, Center for Drug Evaluation and Research (6411), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6478, Silver Spring, MD 20993-0002, 301-796-0700; or Toni Stifano, Center for Biologics Evaluation and Research (HFM-600), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852, 301-827-6190. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled “Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims.” The term “PRO” refers to one or more concepts about how patients feel or function as perceived and reported by study subjects ( *i.e.* , “patients”). PROs may represent traditional aspects of health such as symptoms and activities of daily living, or broader concepts such as physical function, well-being related to health, and satisfaction with treatment. “PRO instruments” are the tools for measuring PROs. Generally, sponsors can use study results measured by PRO instruments to support claims in approved product labeling if the claims are derived from adequate and well-controlled investigations using PRO instruments that reliably and validly measure the specific concepts claimed. The amount of evidence expected to support a labeling claim measured by a PRO instrument is the same as that required for any other labeling claim. As with other labeling claims, the determination of whether the endpoint is an adequate measure of effectiveness is specific to the intended population, the characteristics of the condition or disease treated, and the sensitivity of the clinical study used to measure the endpoint. This draft guidance presents our current thinking on the review process concerning the development, validation, and application of PRO instruments in the clinical study setting. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on patient-reported outcome measures. 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 statutes and regulations. II. 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. III. Electronic Access Persons with access to the Internet may obtain the document at *http://www.fda.gov/ohrms/dockets/default.htm* , *http://www.fda.gov/cder/guidance/index.htm* , or *http://www.fda.gov/cber/guidelines.htm* . Dated: January 26, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-1433 Filed 2-2-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing the availability of summaries of medical and clinical pharmacology reviews of pediatric studies submitted in supplements for AMARYL (glimepiride), MOBIC (meloxicam), NORVIR (ritonavir), and NOVOLOG (insulin aspart). These summaries are being made available consistent with the Best Pharmaceuticals for Children Act (the BPCA). For all pediatric supplements submitted under the BPCA, the BPCA requires FDA to make available to the public a summary of the medical and clinical pharmacology reviews of the pediatric studies conducted for the supplement. ADDRESSES: Submit written requests for single copies of the summaries to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Please specify by product name which summary or summaries you are requesting. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the summaries. FOR FURTHER INFORMATION CONTACT: Grace Carmouze, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, rm. 1613, Silver Spring, MD 20993-0002, 301-796-2200, e-mail: *carmouzeg@cder.fda.gov* . SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of summaries of medical and clinical pharmacology reviews of pediatric studies conducted for AMARYL (glimepiride), MOBIC (meloxicam), NORVIR (ritonavir), and NOVOLOG (insulin aspart). The summaries are being made available consistent with section 9 of the BPCA (Pub. L. 107-109). Enacted on January 4, 2002, the BPCA reauthorizes, with certain important changes, the pediatric exclusivity program described in section 505A of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355a). Section 505A of the act permits certain applications to obtain 6 months of marketing exclusivity if, in accordance with the requirements of the statute, the sponsor submits requested information relating to the use of the drug in the pediatric population. One of the provisions the BPCA added to the pediatric exclusivity program pertains to the dissemination of pediatric information. Specifically, for all pediatric supplements submitted under the BPCA, the BPCA requires FDA to make available to the public a summary of the medical and clinical pharmacology reviews of pediatric studies conducted for the supplement (21 U.S.C. 355a(m)(1)). The summaries are to be made available not later than 180 days after the report on the pediatric study is submitted to FDA (21 U.S.C. 355a(m)(1)). Consistent with this provision of the BPCA, FDA has posted on the Internet at *http://www.fda.gov/cder/pediatric/index.htm* , summaries of medical and clinical pharmacology reviews of pediatric studies submitted in supplements for AMARYL (glimepiride), MOBIC (meloxicam), NORVIR (ritonavir), and NOVOLOG (insulin aspart). Copies are also available by mail (see ADDRESSES ). II. Electronic Access Persons with access to the Internet may obtain the document at *http://www.fda.gov/cder/pediatric/index.htm* . Dated: January 27, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-1435 Filed 2-2-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; Comment Request; Tobacco Use Supplement to the Current Population Survey Series: 2006-2007 Tobacco Use Supplement to the Current Population Survey SUMMARY: Under the provisions of Section 3507(c)(2)(A) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health
(NIH)has submitted to the Office of Management and Budget
(OMB)a request to review and approve the information collection listed below. This proposed information collection was previously published in the **Federal Register** on November 1, 2005, page 65906 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comments. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. *Proposed Collection: Title:* Tobacco Use Supplement to the Current Population Survey Series: 2006-2007 Tobacco Use Supplement to the Current Population Survey. *Type of information request:* Reinstatement With Change of OMB #0925-0368, Expiration 01/31/2004. *Need and Use of Information Collection:* The 2006-2007 Tobacco Use Supplement to the Current Population Survey conducted by the Census Bureau will collect data from the civilian non-institutionalized population on tobacco use, smoking prevalence and attempts at cessation; workplace smoking policies; health professional advice to stop smoking; and changes in smoking norms and attitudes. This survey will provide invaluable information to government agencies and departments, other scientists and the general public necessary for tobacco control research, as well as measure progress toward tobacco control as part of the National Cancer Institute's (NCI's) Cancer Progress Report, and the Department of Health and Human Services' Healthy People 2010 Goals. It is also relevant to past reports of NCI plans for the National Investment in Cancer Research and NCI's long term strategic plan for eliminating the suffering and death due to cancer. This survey is part of a continuing series of surveys that were sponsored by NCI and fielded periodically over the 1990's by the Census Bureau as part of the American Stop Smoking Intervention Study for Cancer Prevention (ASSIST) project (OMB #0925-0368, exp. 01/31/01, 12/31/99, 03/31/97, 06/30/93) and made available for general public use. The Tobacco Use Supplements since 2001-02 have been fielded and will be continuing over the next decade alternating between a standard or core tobacco use survey (such as this 2006-2007 survey) and a special topic survey focusing on emerging tobacco control issues (such as the 2003 Tobacco Use Special Cessation Supplement). The survey will allow state specific estimates to be made. Data will be collected in May 2006, August 2006 and January 2007 from approximately 285,000 respondents. The National Cancer Institute is co-sponsoring this survey with the Centers for Disease Control and Prevention. *Frequency of Response:* One-time study. *Affected Public:* Individuals or households. *Type of Respondents:* Persons 15 years of age or older. The annual reporting burden is presented in exhibit 1 below. The annualized cost to respondents is estimated at $177,691. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report. Exhibit 1.—Estimates of Respondent Hour Burden Number of respondents (number of annual respondents) Frequency of response Average burden hours per response Total hour burden (total annual hour burden) 285,000 (95,000) 1 0.1169 33,317 (11,106) *Request for Comments:* Written comments and/or suggestions from the public and affected agencies are invited 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. *Direct Comments to OMB:* Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to: Office of Management and Budget, Office of Regulatory Affairs, New Executive Office Building, Room 10235, Washington, DC 20503. Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Anne Hartman, M.S., M.A., Health Statistician, National Cancer Institute, 6130 Executive Blvd—MSC 7344, Executive Plaza North, Suite 4005, Bethesda, Maryland 20892-7344, or call non-toll free
(301)496-4970, or FAX your request, to
(301)435-3710, or E-mail your request, including your address, to *ah42t@nih.gov* or *Anne_Hartman@nih.gov.* *Comments Due Date:* Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. Dated: January 27, 2006. Rachelle Ragland-Greene, NCI Project Clearance Liaison, National Institutes of Health. [FR Doc. E6-1499 Filed 2-2-06; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (U.S.C. Appendix 2), notice is hereby given of the following meeting. The meetings 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 commerical property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. *Name of Committee:* National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel, Satiety Signaling in Binge Eaters. *Date:* March 16, 2006. *Time:* 3 p.m. to 4 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference Call). *Contact Person:* Lakshmanan Sankaran, PhD., Scientific Review Administrator, Review Branch, DEA, NIDDK, National Institutes of Health, Room 755, 6707 Democracy Boulevard, Bethesda, MD 20892-5452,
(301)594-7799, *Is38oz@nih.gov.* (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) Dated: January 30, 2006. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06-1021 Filed 2-2-06; 8:45 am]
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Traces to 10 documents
U.S. Code
3 references not yet in our index
- Pub. L. 98-417
- Pub. L. 100-670
- Pub. L. 107-109
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cites case law
Notices
Notice of proposed child abuse and neglect research priorities for Fiscal Years 2006-2008 SUMMARY: The Children's Bureau (CB) within the Administration on Children, Youth and Families (ACYF) announces the proposed priorities for research on the causes, prevention, assessment, identification, treatment, cultural and socio-economic distinctions, and the consequences of child abuse and neglect
Pub. L.Pub. L. 98-417
Pub. L.Pub. L. 100-670
Pub. L.Pub. L. 107-109
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