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Code · REGISTER · 2007-03-22 · DEPARTMENT OF EDUCATION · Notices

Notices. Notice

18,920 words·~86 min read·/register/2007/03/22/07-1408

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BILLING CODE 3710-08-M DEPARTMENT OF EDUCATION Office of Special Education and Rehabilitative Services; Overview Information; Technical Assistance and Dissemination To Improve Services and Results for Children With Disabilities—Model Demonstration Centers on Early Childhood Language Intervention; Notice Inviting Applications for New Awards for Fiscal Year
(FY)2007 *Catalog of Federal Domestic Assistance
(CFDA)Number:* 84.326M. *Dates:* *Applications Available:* March 22, 2007. *Deadline for Transmittal of Applications:* May 7, 2007. *Deadline for Intergovernmental Review:* July 5, 2007. *Eligible Applicants:* State educational agencies (SEAs); local educational agencies (LEAs); public charter schools that are LEAs under State law; institutions of higher education (IHEs); other public agencies; private nonprofit organizations; outlying areas; freely associated States; Indian tribes or tribal organizations; and for-profit organizations. *Estimated Available Funds:* $1,200,000. *Estimated Average Size of Award:* $400,000. *Maximum Award:* We will reject any application that proposes a budget exceeding $400,000 for a single budget period of 12 months. The Assistant Secretary for Special Education and Rehabilitative Services may change the maximum amount through a notice published in the **Federal Register** . *Estimated Number of Awards:* 3. Note: The Department is not bound by any estimates in this notice. *Project Period:* Up to 48 months. As described in the *Priority* section of this notice, the Secretary may fund the project for a fifth year to collect and analyze data on children's developmental progress following their participation in the intervention model. Full Text of Announcement I. Funding Opportunity Description *Purpose of Program:* This program promotes academic achievement and improves results for children with disabilities by supporting technical assistance, model demonstration projects, dissemination of useful information, and implementation activities that are supported by scientifically based research. *Priority:* In accordance with 34 CFR 75.105(b)(2)(v), this priority is from allowable activities specified in the statute (see sections 663 and 681(d) of the Individuals with Disabilities Education Act (IDEA)). *Absolute Priority:* For FY 2007 this priority is an absolute priority. Under 34 CFR 75.105(c)(3), we consider only applications that meet this priority. *This priority is:* Model Demonstration Centers on Early Childhood Language Intervention *Background:* Children's ability to communicate and the quality of their communication affect their developmental trajectories, their learning, their ability to interact with and relate to others, and their success in school. Communication is accomplished through the use of a shared code, i.e., language, which can be a spoken, written or other symbol system. While language development typically is a robust process for children, there are factors that can negatively affect language acquisition either by limiting the quality or quantity of linguistic input a child receives or by interfering with the way in which a child processes that input (National Research Council, 2000). A language disorder is defined as impaired comprehension and/or use of language. While a language disorder may be a child's primary disability, it may be secondary to other disabilities such as autism or a hearing impairment (including deafness). Many young children receiving services under IDEA participate in speech and language interventions. In the National Early Intervention Longitudinal Study (NEILS), service providers reported that 53 percent of infants and toddlers received speech and language therapy within the first six months of beginning early intervention services. Additionally, the 2004 IDEA child count data indicate that 47 percent of three through five year olds served under the Part B program of IDEA have speech or language impairments, though the actual number is likely to be much higher because this number does not include children who have speech or language impairments but are identified as having a developmental delay and children with primary disabilities other than speech or language impairments who also have language disorders. Functional or naturalistic language interventions have been shown to be effective in increasing the overall quantity and quality of children's communication and language skills (Owens, 2004; Warren, Yoder, & Leew, 2002). A functional language approach to intervention is grounded in the principle that language develops for the purpose of communicating within a social environment. Intervention practices or teaching strategies are therefore implemented within the context of children's daily activities and routines to promote their communication and language development. This intervention approach is child-centered in that it focuses on children's interests and supports their attempts to communicate within social interactions. A functional language approach stresses the importance of engaging adults in a child's environment, including family members, childcare providers, and interventionists as language facilitators so that they can use empirically valid strategies to support children's language and communication development across communicative contexts and partners. A functional language approach is different from language interventions that are directed by an adult and target discrete, isolated language skills within artificial situations. Children with significant language disorders are often served by a variety of professionals, and it is not uncommon for them to receive interventions that are based on one theoretical and empirical framework for the first few years and then transition to a program that emphasizes a very different approach with divergent theoretical underpinnings and empirical support. If this shift in intervention approaches is dramatic, the child may lose skills he or she has acquired under the previous approach and family members may experience confusion and uncertainty about what the child should be learning and how they should support those experiences. Continuity in the interventions that are provided across early intervention and preschool settings could lessen any confusion and uncertainty experienced by families of young children with disabilities as they transition from one program to another. Children with significant language disorders are at high risk for social and academic difficulties. To support infants, toddlers, and preschoolers with disabilities in developing the skills they will need to communicate competently, there is a need for a scientifically based evaluation of effective functional language intervention models implemented within natural settings. This need is especially critical for young children with significant language disorders who are served across both early intervention and preschool programs. The Department is interested in evaluating functional language intervention models that address the diverse population of infants, toddlers, and preschool children served under both Part C and Part B of IDEA, especially those children who need intensive language interventions as a result of a specific language disorder, or a language disorder that is secondary to other disabilities such as autism or a hearing impairment (including deafness). *Priority:* The purpose of this priority is to support three
(3)Centers to evaluate models that incorporate scientifically based research related to language interventions for children birth through five with significant language disorders served across the Part C and Part B preschool programs under IDEA. Each Center will work with no less than three sites and will implement the same functional language intervention model in each of these sites. Each site must serve children with disabilities ages birth through five, either in separate early intervention and preschool programs within the same community or through a coordinated system that serves children with disabilities ages birth through five. Each site must include both an early intervention component and a preschool component so that critical elements of the language intervention models are consistent as children transition from IDEA Part C to Part B services. Each Center must implement and evaluate the functional language intervention model in early childhood environments, such as child care settings, Head Start programs, private or public preschools, early childhood special education settings, and home/community-based environments to determine their usefulness, effectiveness, and general applicability to these typical settings. An applicant must describe, in its application—
(a)The proposed model and the supporting evidence for the model as a whole, including empirical support of the critical components that comprise the model;
(b)The knowledge, experience, and capabilities of the key staff who will be responsible for the development and implementation of the functional language intervention model across the early intervention and preschool programs;
(c)The methods to be used for recruiting and selecting sites, and if the applicant has identified sites that would be willing to participate in the model demonstrations, a description of the population of children typically served by these sites. The final site selection will be determined following the first cross-project meeting; and
(d)The partnership that the Center has established with local early intervention and preschool programs to implement the model and to increase the likelihood that personnel will develop sufficient expertise in order to sustain the model after project completion. To meet the requirements of this priority, each Center, at a minimum, must—
(1)Conduct a systematic review of the research on evidence-based language interventions that focuses on functional communication within natural settings that are appropriate for young children ages birth through five with significant language disorders. To the extent possible, the Center must use the standards established by the What Works Clearinghouse, ( *http://www.whatworks.ed.gov/reviewprocess/study_standards_final/pdf* ). If it is not possible to use these standards, other rigorous standards must be used to identify evidence-based interventions and practices;
(2)Design and implement a language intervention model that:
(a)Focuses on language development and readiness skills for young children ages birth through five with significant language disorders;
(b)is grounded in a scientifically based functional approach to language intervention that is embedded within the context of practices that are developmentally appropriate and empirically supported;
(c)takes into account continuity of interventions by enrolling children in the Part C program and following them through the Part B program until the completion of the model demonstration project;
(d)can be adapted based on specific characteristics of the child, such as age and disability; and
(e)is designed to lead to improved outcomes for young children with significant language disorders;
(3)Provide initial and ongoing professional development to early interventionists, early childhood special educators, related service providers, and early care and education personnel in the project working with young children with disabilities and who are charged with implementing the model. Ensure that there is a process for providing feedback to personnel participating in the project on their implementation of the language intervention model;
(4)Implement an evaluation plan that includes a detailed description of the full model and the critical elements of the model, a description of the system variables required to implement and sustain the model, and the processes for collecting and analyzing specific project and cross-project data related to:
(a)The effectiveness of the language intervention model, including child outcomes;
(b)the fidelity of the implementation of the model and acceptable variations;
(c)the continuity of the model across the Part C and Part B programs; and
(d)the effectiveness of the professional development provided to personnel participating in the model demonstrations. Common cross-site data to be collected will be determined following the first cross-project meeting;
(5)Document the effects of a consistent language intervention approach on the transition process as children move from the IDEA Part C program to the Part B program;
(6)Identify methods for effectively supporting communication and collaboration among families, community agencies, and program/Center staff to implement the language intervention model across the Part C and Part B programs;
(7)Coordinate with the other Centers funded under this competition and the Model Demonstration Coordination Center
(MDCC)to determine a cross-project plan for evaluating the impact of these models on children's developmental progress and outcomes. The MDCC is a separate center funded by OSEP that is responsible for coordinating implementation and analyzing data to determine the effectiveness of intervention models. The MDCC is developing a data coordination plan and cross-site data collection instruments and will generate common evaluation questions, synthesize and analyze data, monitor implementation fidelity, ensure data reliability, and foster information dissemination. As part of cross-site coordination, Centers will be asked to collect common measures that may or may not be the same as those proposed by the applicant. Common measures may include observations or assessments of programs, classrooms, or children participating in the language intervention model as well as programs, classrooms, or children who were not part of the language intervention model. The purpose of the data is to provide general information on the contexts in which models are more fully implemented and effective;
(8)Develop regular communication with OSEP's other funded centers, as appropriate, to share information regarding topics such as successful strategies and implementation challenges for language interventions for children with significant language disorders in early childhood environments;
(9)As appropriate, develop and apply strategies for disseminating implementation information to specific audiences, including early interventionists, preschool special educators, related service providers, families, administrators, policymakers, and researchers. These dissemination strategies must involve collaboration with MDCC, and with technical assistance providers, including parent centers funded by OSEP;
(10)Prior to developing any new product, whether paper or electronic, submit for approval a proposal describing the content and purpose of the product to the Project Officer to be designated by OSEP and the document review board of OSEP's Dissemination Center;
(11)Budget for the Center's project director to attend a three-day Project Directors' meeting in Washington, D.C. during each year of the project; and one additional yearly meeting with OSEP and the MDCC (the first meeting to take place within one month of the project's January 1, 2008 start date);
(12)If a Web site is maintained, format the information and documents on the Web site in a manner that meets a government or industry-recognized standard for accessibility. *Fifth Year of the Project:* In deciding whether to continue funding the Center for the fifth year, the Secretary will consider the requirements of 34 CFR 75.253(a), and in addition—
(a)The timeliness and effectiveness with which all requirements of the negotiated cooperative agreement have been or are being met by the Center;
(b)The degree to which the Center recruited and retained a large enough sample of children to allow for meaningful data collection and analysis of where children were served, the type of services they received, and their developmental progress and outcomes once they exited preschool programs. *Waiver of Proposed Rulemaking:* Under the Administrative Procedure Act
(APA)(5 U.S.C. 553), the Department generally offers interested parties the opportunity to comment on a proposed priority. However, section 681(d) of IDEA makes the public comment requirements under the APA inapplicable to the priority in this notice. Program Authority: 20 U.S.C. 1463 and 1481(d). *Applicable Regulations:* The Education Department General Administrative Regulations (EDGAR) in 34 CFR parts 74, 75, 77, 79, 80, 81, 82, 84, 85, 86, 97, 98, and 99. Note: The regulations in 34 CFR part 79 apply to all applicants except federally recognized Indian tribes. Note: The regulations in 34 CFR part 86 apply only to IHEs. II. Award Information *Type of Award:* Cooperative agreement. *Estimated Available Funds:* $1,200,000. *Estimated Average Size of Award:* $400,000. *Maximum Award:* We will reject any application that proposes a budget exceeding $400,000 for a single budget period of 12 months. The Assistant Secretary for Special Education and Rehabilitative Services may change the maximum amount through a notice published in the **Federal Register** . *Estimated Number of Awards:* 3. Note: The Department is not bound by any estimates in this notice. *Project Period:* Up to 48 months. As described in the *Priority* section of this notice, the Secretary may fund the project for a fifth year to collect and analyze data on children's developmental progress following their participation in the intervention model. III. Eligibility Information 1. *Eligible Applicants:* SEAs; LEAs; public charter schools that are LEAs under State law; IHEs; other public agencies; private nonprofit organizations; outlying areas; freely associated States; Indian tribes or tribal organizations; and for-profit organizations. 2. *Cost Sharing or Matching:* This competition does not involve cost sharing or matching. 3. *Other:* *General Requirements* —(a) The projects funded under this competition must make positive efforts to employ and advance in employment qualified individuals with disabilities (see section 606 of IDEA).
(b)Applicants and grant recipients funded under this competition must involve individuals with disabilities or parents of individuals with disabilities ages birth through 26 in planning, implementing, and evaluating the projects (see section 682(a)(1)(A) of IDEA). IV. Application and Submission Information 1. *Address to Request Application Package:* Education Publications Center (ED Pubs), P.O. Box 1398, Jessup, MD 20794-1398. *Telephone (toll free):* 1-877-433-7827. *FAX:*
(301)470-1244. If you use a telecommunications device for the deaf (TDD), you may call (toll free): 1-877-576-7734. You may also contact ED Pubs at its Web site: *http://www.ed.gov/pubs/edpubs.html* or you may contact ED Pubs at its e-mail address: *edpubs@inet.ed.gov.* If you request an application from ED Pubs, be sure to identify this competition as follows: CFDA Number 84.326M. Individuals with disabilities may obtain a copy of the application package in an alternative format (e.g., Braille, large print, audiotape, or computer diskette) by contacting the Grants and Contracts Services Team listed under For Further Information Contact in section VII of this notice. 2. *Content and Form of Application Submission:* Requirements concerning the content of an application, together with the forms you must submit, are in the application package for this competition. *Page Limit:* The application narrative (Part III of the application) is where you, the applicant, address the selection criteria that reviewers use to evaluate your application. You must limit Part III to the equivalent of no more than 70 pages, using the following standards: • A “page” is 8.5″ x 11″, on one side only, with 1″ margins at the top, bottom, and both sides. • Double space (no more than three lines per vertical inch) all text in the application narrative, including titles, headings, footnotes, quotations, references, and captions, as well as all text in charts, tables, figures, and graphs. • Use a font that is either 12 point or larger or no smaller than 10 pitch (characters per inch). The page limit does not apply to Part I, the cover sheet; Part II, the budget section, including the narrative budget justification; Part IV, the assurances and certifications; the one-page abstract, the resumes, the bibliography, the references, or the letters of support. However, you must include all of the application narrative in Part III. We will reject your application if— • You apply these standards and exceed the page limit; or • You apply other standards and exceed the equivalent of the page limit. 3. *Submission Dates and Times:* *Applications Available:* March 22, 2007. *Deadline for Transmittal of Applications:* May 7, 2007. Applications for grants under this competition may be submitted electronically using the Grants.gov Apply site (Grants.gov), or in paper format by mail or hand delivery. For information (including dates and times) about how to submit your application electronically, or by mail or hand delivery, please refer to section IV. 6. *Other Submission Requirements* in this notice. We do not consider an application that does not comply with the deadline requirements. Individuals with disabilities who need an accommodation or auxiliary aid in connection with the application process should contact the person listed under For Further Information Contact . *Deadline for Intergovernmental Review:* July 5, 2007. 4. *Intergovernmental Review:* This program is subject to Executive Order 12372 and the regulations in 34 CFR part 79. Information about Intergovernmental Review of Federal Programs under Executive Order 12372 is in the application package for this competition. 5. *Funding Restrictions:* We reference regulations outlining funding restrictions in the *Applicable Regulations* section of this notice. 6. *Other Submission Requirements:* Applications for grants under this competition may be submitted electronically or in paper format by mail or hand delivery. a. *Electronic Submission of Applications.* We have been accepting applications electronically through the Department's e-Application system since FY 2000. In order to expand on those efforts and comply with the President's Management Agenda, we are continuing to participate as a partner in the new government wide *Grants.gov* Apply site in FY 2007. The Model Demonstration Centers on Early Childhood Language Intervention-CFDA Number 84.326M is one of the competitions included in this project. We request your participation in *Grants.gov.* If you choose to submit your application electronically, you must use the *Grants.gov* Apply site at *http://www.Grants.gov.* Through this site, you will be able to download a copy of the application package, complete it offline, and then upload and submit your application. You may not e-mail an electronic copy of a grant application to us. You may access the electronic grant application for The Model Demonstration Centers on Early Childhood Language Intervention at: *http://www.grants.gov.* You must search for the downloadable application package for this program by the CFDA number. Do not include the CFDA number's alpha suffix in your search. Please note the following: • Your participation in *Grants.gov* is voluntary. • When you enter the *Grants.gov* site, you will find information about submitting an application electronically through the site, as well as the hours of operation. • Applications received by *Grants.gov* are time and date stamped. Your application must be fully uploaded and submitted, and must be date/time stamped by the *Grants.gov* system no later than 4:30 p.m., Washington, DC time, on the application deadline date. Except as otherwise noted in this section, we will not consider your application if it is date/time stamped by the *Grants.gov* system later than 4:30 p.m., Washington, DC time, on the application deadline date. When we retrieve your application from *Grants.gov* , we will notify you if we are rejecting your application because it was date/time stamped by the *Grants.gov* system after 4:30 p.m., Washington, DC time, on the application deadline date. • The amount of time it can take to upload an application will vary depending on a variety of factors including the size of the application and the speed of your Internet connection. Therefore, we strongly recommend that you do not wait until the application deadline date to begin the application process through *Grants.gov.* • You should review and follow the Education Submission Procedures for submitting an application through *Grants.gov* that are included in the application package for this competition to ensure that you submit your application in a timely manner to the *Grants.gov* system. You can also find the Education Submission Procedures pertaining to *Grants.gov* at *http://e-Grants.ed.gov/help/GrantsgovSubmissionProcedures.pdf.* • To submit your application via *Grants.gov* , you must complete all of the steps in the *Grants.gov* registration process ( *see http://www.grants.gov/applicants/get_registered.jsp* ). These steps include
(1)registering your organization,
(2)registering yourself as an Authorized Organization Representative (AOR), and
(3)getting authorized as an AOR by your organization. Details on these steps are outlined in the *Grants.gov* 3-Step Registration Guide (see *http://www.grants.gov/section910/Grants.govRegistrationBrochure.pdf* ). You also must provide on your application the same D-U-N-S Number used with this registration. Please note that the registration process may take five or more business days to complete, and you must have completed all registration steps to allow you to successfully submit an application via *Grants.gov.* • You will not receive additional point value because you submit your application in electronic format, nor will we penalize you if you submit your application in paper format. • You may submit all documents electronically, including all information typically included on the Application for Federal Education Assistance (ED 424), Budget Information—Non-Construction Programs (ED 524), and all necessary assurances and certifications. If you choose to submit your application electronically, you must attach any narrative sections of your application as files in a .DOC (document), .RTF (rich text) or .PDF (Portable Document) format. If you upload a file type other than the three file types specified above or submit a password protected file, we will not review that material. • Your electronic application must comply with any page limit requirements described in this notice. • After you electronically submit your application, you will receive an automatic acknowledgment from Grants.gov that contains a Grants.gov tracking number. The Department will retrieve your application from Grants.gov and send you a second confirmation by e-mail that will include a PR/Award number (an ED-specified identifying number unique to your application). • We may request that you provide us original signatures on forms at a later date. Application Deadline Date Extension in Case of System Unavailability If you are prevented from electronically submitting your application on the application deadline date because of technical problems with the Grants.gov system, we will grant you an extension until 4:30 p.m., Washington, DC time, the following business day to enable you to transmit your application electronically, or by hand delivery. You also may mail your application by following the mailing instructions as described elsewhere in this notice. If you submit an application after 4:30 p.m., Washington, DC time, on the deadline date, please contact the person listed elsewhere in this notice under For Further Information Contact , and provide an explanation of the technical problem you experienced with Grants.gov, along with the Grants.gov Support Desk Case Number (if available). We will accept your application if we can confirm that a technical problem occurred with the Grants.gov system and that that problem affected your ability to submit your application by 4:30 p.m., Washington, DC time, on the application deadline date. The Department will contact you after a determination is made on whether your application will be accepted. Note: Extensions referred to in this section apply only to the unavailability of or technical problems with the Grants.gov system. We will not grant you an extension if you failed to fully register to submit your application to Grants.gov before the deadline date and time or if the technical problem you experienced is unrelated to the Grants.gov system. b. *Submission of Paper Applications by Mail.* If you submit your application in paper format by mail (through the U.S. Postal Service or a commercial carrier), you must mail the original and two copies of your application, on or before the application deadline date, to the Department at the applicable following address: *By mail through the U.S. Postal Service:* U.S. Department of Education, Application Control Center, *Attention:* (CFDA Number 84.326M), 400 Maryland Avenue, SW., Washington, DC 20202-4260. or *By mail through a commercial carrier:* U.S. Department of Education, Application Control Center—Stop 4260, *Attention:* (CFDA Number 84.326M), 7100 Old Landover Road, Landover, MD 20785-1506. Regardless of which address you use, you must show proof of mailing consisting of one of the following:
(1)A legibly dated U.S. Postal Service postmark,
(2)A legible mail receipt with the date of mailing stamped by the U.S. Postal Service,
(3)A dated shipping label, invoice, or receipt from a commercial carrier, or
(4)Any other proof of mailing acceptable to the Secretary of the U.S. Department of Education. If you mail your application through the U.S. Postal Service, we do not accept either of the following as proof of mailing:
(1)A private metered postmark, or
(2)A mail receipt that is not dated by the U.S. Postal Service. If your application is postmarked after the application deadline date, we will not consider your application. Note: The U.S. Postal Service does not uniformly provide a dated postmark. Before relying on this method, you should check with your local post office. c. *Submission of Paper Applications by Hand Delivery.* If you submit your application in paper format by hand delivery, you (or a courier service) must deliver the original and two copies of your application by hand, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Application Control Center, *Attention:* (CFDA Number 84.326M), 550 12th Street, SW., Room 7041, Potomac Center Plaza, Washington, DC 20202-4260. The Application Control Center accepts hand deliveries daily between 8 a.m. and 4:30 p.m., Washington, DC time, except Saturdays, Sundays and Federal holidays. Note for Mail or Hand Delivery of Paper Applications: If you mail or hand deliver your application to the Department:
(1)You must indicate on the envelope and—if not provided by the Department—in Item 4 of ED 424 the CFDA number—and suffix letter, if any—of the competition under which you are submitting your application.
(2)The Application Control Center will mail a grant application receipt acknowledgment to you. If you do not receive the grant application receipt acknowledgment within 15 business days from the application deadline date, you should call the U.S. Department of Education Application Control Center at
(202)245-6288. V. Application Review Information 1. *Selection Criteria:* The selection criteria for this competition are from 34 CFR 75.210 and are listed in the application package. 2. *Treating A Priority As Two Separate Competitions:* In the past, there have been problems in finding peer reviewers without conflicts of interest for competitions in which many entities throughout the country submit applications. The Standing Panel requirements under IDEA also have placed additional constraints on the availability of reviewers. Therefore, the Department has determined that, for some discretionary competitions, applications may be separated into two or more groups and ranked and selected for funding within the specific group. This procedure will ensure the availability of a much larger group of reviewers without conflicts of interest. It also will increase the quality, independence and fairness of the review process and permit panel members to review applications under discretionary competitions for which they have also submitted applications. However, if the Department decides to select for funding an equal number of applications in each group, this may result in different cut-off points for fundable applications in each group. VI. Award Administration Information 1. *Award Notices:* If your application is successful, we notify your U.S. Representative and U.S. Senators and send you a Grant Award Notification (GAN). We may also notify you informally. If your application is not evaluated or not selected for funding, we notify you. 2. *Administrative and National Policy Requirements:* We identify administrative and national policy requirements in the application package and reference these and other requirements in the *Applicable Regulations* section of this notice. We reference the regulations outlining the terms and conditions of an award in the *Applicable Regulations* section of this notice and include these and other specific conditions in the GAN. The GAN also incorporates your approved application as part of your binding commitments under the grant. 3. *Reporting:* At the end of your project period, you must submit a final performance report, including financial information, as directed by the Secretary. If you receive a multi-year award, you must submit an annual performance report that provides the most current performance and financial expenditure information as specified by the Secretary in 34 CFR 75.118. 4. *Performance Measures:* Under the Government Performance and Results Act (GPRA), the Department has developed measures that will yield information on various aspects of the Technical Assistance and Dissemination to Improve Services and Results for Children with Disabilities program. These measures focus on: the extent to which projects provide high quality products and services, the relevance of project products and services to educational and early intervention policy and practice, and the use of products and services to improve educational and early intervention policy and practice. Grantees will be required to provide information related to these measures. Grantees will also be required to report information on their projects' performance in annual reports to the Department (34 CFR 75.590). VII. Agency Contact *For Further Information Contact:* Christy Kavulic, U.S. Department of Education, 400 Maryland Avenue, SW., room 4057, Potomac Center Plaza, Washington, DC 20202-2550. Telephone:
(202)245-7359. If you use a telecommunications device for the deaf (TDD), you may call the Federal Relay Service
(FRS)at 1-800-877-8339. Individuals with disabilities may obtain this document in an alternative format (e.g., Braille, large print, audiotape, or computer diskette) on request by contacting the following office: The Grants and Contracts Services Team, U.S. Department of Education, 400 Maryland Avenue, SW., Potomac Center Plaza, Washington, DC 20202-2550. *Telephone:*
(202)245-7363. VIII. Other Information *Electronic Access to This Document:* You may view this document, as well as all other documents of this Department published in the **Federal Register,** in text or Adobe Portable Document Format
(PDF)on the Internet at the following site: *http://www.ed.gov/news/fedregister* . To use PDF you must have Adobe Acrobat Reader, which is available free at this site. If you have questions about using PDF, call the U.S. Government Printing Office (GPO), toll free, at 1-888-293-6498; or in the Washington, DC, area at
(202)512-1530. Note: The official version of this document is the document published in the **Federal Register.** Free Internet access to the official edition of the **Federal Register** and the Code of Federal Regulations is available on GPO Access at: *http://www.gpoaccess.gov/nara/index.html* . Dated: March 16, 2007. John H. Hager, Assistant Secretary for Special Education and Rehabilitative Services. [FR Doc. E7-5267 Filed 3-21-07; 8:45 am] BILLING CODE 4000-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. PR07-9-000] Bay Gas Storage Company, Ltd.; Notice of Rate Filing March 16, 2007. Take notice that on March 8, 2007, Bay Gas Storage Company, Ltd. (Bay Gas) filed a petition for rate approval pursuant to section 284.123(b)(2) of the Commission's regulations. Bay Gas requests the Commission to approve incremental rates for Bay Gas's mainline facilities for firm transportation and interruptible transportation services and also rates for Bay Gas's Whistler spur facilities for firm transportation and interruptible services for transportation of natural gas under section 311(a)(2) of the Natural Gas Policy Act of 1978. In addition, Bay Gas proposes a tracking methodology for lost-and-unaccounted-for gas volumes cost recovery, and a gas quality/interchangeability provision. Any person desiring to participate in this rate proceeding must file a motion to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the date as indicated below. Anyone filing an intervention or protest must serve a copy of that document on the Applicant. Anyone filing an intervention or protest on or before the intervention or protest date need not serve motions to intervene or protests on persons other than the Applicant. The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at *http://www.ferc.gov.* Persons unable to file electronically should submit an original and 14 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. This filing is accessible on-line at *http://www.ferc.gov,* using the “eLibrary” link and is available for review in the Commission's Public Reference Room in Washington, DC. There is an “eSubscription” link on the Web site that enables subscribers to receive e-mail notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please e-mail *FERCOnlineSupport@ferc.gov,* or call
(866)208-3676 (toll free). For TTY, call
(202)502-8659. *Comment Date:* 5 p.m. Eastern Time March 27, 2007. Philis J. Posey, Acting Secretary. [FR Doc. E7-5203 Filed 3-21-07; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. PR03-11-005] Enbridge Pipelines (Louisiana Intrastate) LLC; Notice of Compliance Filing March 16, 2007. Take notice that on March 5, 2007, Enbridge Pipelines (Louisiana Intrastate) LLC filed its annual revision of the fuel percentage on its system pursuant to section 3.2 of its Statement of Operating Conditions. Louisiana Intrastate seeks an effective date of April 1, 2007. Any person desiring to participate in this rate proceeding must file a motion to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the date as indicated below. Anyone filing an intervention or protest must serve a copy of that document on the Applicant. Anyone filing an intervention or protest on or before the intervention or protest date need not serve motions to intervene or protests on persons other than the Applicant. The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at *http://www.ferc.gov.* Persons unable to file electronically should submit an original and 14 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. This filing is accessible on-line at *http://www.ferc.gov,* using the “eLibrary” link and is available for review in the Commission's Public Reference Room in Washington, DC. There is an “eSubscription” link on the Web site that enables subscribers to receive e-mail notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please e-mail *FERCOnlineSupport@ferc.gov,* or call
(866)208-3676 (toll free). For TTY, call
(202)502-8659. *Comment Date:* 5 p.m. Eastern Time on March 27, 2007. Philis J. Posey, Acting Secretary. [FR Doc. E7-5202 Filed 3-21-07; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP07-98-000] Southern Natural Gas Company; Notice of Application March 16, 2007. Take notice that on March 16, 2007, Southern Natural Gas Company (Southern), P.O. Box 2563, Birmingham, Alabama 35202-2563, filed in Docket No. CP07-98-000 an application pursuant to section 7(b) of the Commission's regulations under the Natural Gas Act (NGA), for authorization to abandon, by sale, to Atmos Energy Corporation (Atmos), its Columbus Lateral Line, its Columbus Lateral Loop Line, and its Columbus Meter Station. Southern also proposes to construct a new meter station under Section 157.211(a) and its blanket authority granted in Docket No. CP82-406-000 on September 1, 1982, to replace the Columbus Meter Station that will be sold to Atmos. The new meter station will be constructed and installed at the new interconnection between Southern's facilities and Atmos' facilities on Southern's West Point Line and Loop. All of the facilities are located in Lowndes County, Mississippi. This filing is available for review at the Commission in the Public Reference Room or may be viewed on the web at *http://www.ferc.gov* using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact FERC at *FERCOnlineSupport@gerc.gov* or call toll-free,
(886)208-3676 or TYY,
(202)502-8659. In addition, Southern states that the proposed abandonment by sale and construction will not cause any adverse impact to its customers or their requirements because the sale will simply result in relocation of the existing custody transfer point for the Columbus Delivery Point and shippers' transactions will not be affected. Any questions regarding this application should be directed to Patrick B. Pope, Vice President and General Counsel, Southern Natural Gas Company, Post Office Box 2563, Birmingham, Alabama 35202-2563 at
(205)325-7126, or Patricia S. Francis, Senior Counsel, Southern Natural Gas Company, Post Office Box 2563, Birmingham, Alabama 35202-2563 at
(205)325-7696. Pursuant to Section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the Commission staff will either: Complete its environmental assessment
(EA)and place it into the Commission's public record (eLibrary) for this proceeding; or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the final environmental impact statement
(FEIS)or EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify Federal and State agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all Federal authorizations within 90 days of the date of issuance of the Commission staff's FEIS or EA. There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, on or before the comment date, file with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by all other parties. A party must submit 14 copies of filings made with the Commission and must mail a copy to the applicant and to every other party in the proceeding. Only parties to the proceeding can ask for court review of Commission orders in the proceeding. However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest. Persons who wish to comment only on the environmental review of this project, or in support of or in opposition to this project, should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commenters will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commenters will not be required to serve copies of filed documents on all other parties. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the applicant. However, the non-party commenters will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order. The Commission strongly encourages electronic filings of comments, protests, and interventions via the internet in lieu of paper. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site ( *www.ferc.gov* ) under the “e-Filing” link. *Comment Date:* April 6, 2007. Philis J. Posey, Acting Secretary. [FR Doc. E7-5201 Filed 3-21-07; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #1 March 16, 2007. Take notice that the Commission received the following electric rate filings: *Docket Numbers:* ER07-421-001. *Applicants:* Wisconsin Power and Light Company. *Description:* Wisconsin Power and Light Company submits a revised Power Supply Agreement in compliance with FERC's 2/16/07 Order. *Filed Date:* 03/14/2007. *Accession Number:* 20070315-0084. *Comment Date:* 5 p.m. Eastern Time on Wednesday, April 04, 2007. *Docket Numbers:* ER07-612-000. *Applicants:* New York Independent System Operator, Inc. *Description:* New York Independent System Operator, Inc submits corrected tariff sheets for its Market Administration and Control Area Services Tariff and its Open Access Transmission Tariff. *Filed Date:* 03/09/2007. *Accession Number:* 20070315-0086. *Comment Date:* 5 p.m. Eastern Time on Friday, March 23, 2007. *Docket Numbers:* ER07-613-000. *Applicants:* California Independent System Operator Corporation. *Description:* California Independent System Operator Corporation submits certain amendments to the currently-effective ISO Tariff designed to facilitate implementation of the Market Redesign and Technology Upgrade Program. *Filed Date:* 03/09/2007. *Accession Number:* 20070315-0087. *Comment Date:* 5 p.m. Eastern Time on Friday, March 30, 2007. *Docket Numbers:* ER07-614-000. *Applicants:* American Transmission Systems, Incorporated. *Description:* American Transmission Systems, Inc submits a Construction Agreement designated as Service Agreement 349, FERC Electric Tariff, Second Revised Volume 1, effective 1/5/07. *Filed Date:* 03/09/2007. *Accession Number:* 20070315-0088. *Comment Date:* 5 p.m. Eastern Time on Friday, March 30, 2007. *Docket Numbers:* ER07-619-000. *Applicants:* NSTAR Electric Company. *Description:* NSTAR Electric Company submits the Cost Allocation Agreement for Braintree Tap Upgrades between NSTAR and Braintree Electric Light Department, designated as Rate Schedule 215. *Filed Date:* 03/14/2007. *Accession Number:* 20070315-0085. *Comment Date:* 5 p.m. Eastern Time on Wednesday, April 04, 2007. Any person desiring to intervene or to protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214) on or before 5 p.m. Eastern time on the specified comment date. It is not necessary to separately intervene again in a subdocket related to a compliance filing if you have previously intervened in the same docket. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant. In reference to filings initiating a new proceeding, interventions or protests submitted on or before the comment deadline need not be served on persons other than the Applicant. The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at *http://www.ferc.gov.* To facilitate electronic service, persons with Internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests. Persons unable to file electronically should submit an original and 14 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First, St., NE., Washington, DC 20426. The filings in the above proceedings are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive e-mail notification when a document is added to a subscribed dockets(s). For assistance with any FERC Online service, please e-mail *FERCOnlineSupport@ferc.gov.* or call
(866)208-3676 (toll free). For TTY, call
(202)502-8659. Philis J. Posey, Acting Secretary. [FR Doc. E7-5204 Filed 3-21-07; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket Nos. CP06-354-000; CP06-401-000; CP06-423-000] Rockies Express Pipeline, LLC; TransColorado Gas Transmission Company; Questar Overthrust Pipeline Company; Notice of Availability of the Final Environmental Impact Statement for the Rockies Western Phase Project March 16, 2007. The staff of the Federal Energy Regulatory Commission (FERC or Commission) has prepared a final Environmental Impact Statement
(EIS)for the construction and operation of the natural gas pipeline facilities proposed by Rockies Express Pipeline LLC (Rockies Express), TransColorado Gas Transmission Company (TransColorado), and Questar Overthrust Pipeline Company (Overthrust) in the above-referenced dockets. These individual project sponsors have submitted separate and distinct proposals to the Commission; however, the FERC views the proposed facilities as interconnected projects that are necessary components of a larger, combined natural gas transportation system. As such, all three project proposals have been included in the final EIS, and are collectively referred to as the Rockies Western Phase Project (or the Project). The Project facilities would be located in Colorado, Wyoming, Nebraska, Kansas, Missouri, and New Mexico. The final EIS was prepared to satisfy the requirements of the National Environmental Policy Act
(NEPA)and the Federal Land Management and Policy Act. The U.S. Bureau of Land Management
(BLM)and U.S. Fish and Wildlife Service
(FWS)are federal land management agencies with lands affected by this proposal and are cooperating agencies for the development of the EIS. A cooperating agency has jurisdiction by law or special expertise with respect to potential environmental impacts associated with the proposal, and is involved in the NEPA analysis. The Project would cross federal land under the jurisdiction of the BLM Rawlins, Kemmerer, and Rock Springs Field Offices. Lands administered by the FWS would also be crossed by the Project. Under section 185(f) of the Mineral Leasing Act of 1920, the BLM has the authority to issue Right-of-Way Grants for all affected federal lands. The FERC staff has concluded that if the Project is constructed and operated in accordance with applicable laws and regulations, and each project sponsor's proposed mitigation, and the staffs' additional mitigation recommendations, it would have limited adverse environmental impact and would be an environmentally acceptable action. As currently proposed, the Rockies Western Phase Project would consist of the construction and operation of approximately 795.6 miles of natural gas pipeline and a total of 237,320 horsepower of new compression. Following completion of the proposed facilities, the Project would transport up to 1.5 billion cubic feet of natural gas per day. Specifically, the final EIS addresses the potential environmental effects of the construction and operation of the following natural gas pipeline facilities proposed by Rockies Express, TransColorado, and Overthrust: Rockies Express (REX-West Project) • 712.7 miles of 42-inch-diameter natural gas pipeline in Wyoming, Colorado, Nebraska, Kansas, and Missouri; • 5.3 miles of 24-inch-diameter pipeline (Echo Springs Lateral) in Sweetwater and Carbon Counties, Wyoming; • Five new compressor stations (Cheyenne Compressor Station in Weld County, Colorado; Julesburg Compressor Station in Sedgwick County, Colorado; Echo Springs Compressor Station in Sweetwater County, Wyoming; the Steele City Compressor Station in Gage County, Nebraska; and Turney Compressor Station in Clinton County, Missouri); • Four new compressor units at two previously certificated compressor stations (Meeker Compressor Station in Rio Blanco County, Colorado and Wamsutter Compressor Station in Sweetwater County, Wyoming); and • 8 new meter stations, 41 mainline valves, and associated facilities. TransColorado (Blanco to Meeker Project) • 392 feet of discharge line and 478 feet of suction line, 1,300 feet of 24-inch-diameter pipeline, and 60 feet of 16-inch-diameter pipeline in San Juan County, New Mexico; • Two new compressor stations (Blanco Compression Station in San Juan County, New Mexico and the Conn Creek Compressor Station in Garfield County, Colorado); • Modifications at four existing compressor stations (Mancos Compressor Station in Montezuma County, Colorado; Redvale Compressor Station in Montrose County, Colorado; Whitewater Compressor Station in Mesa County, Colorado, and the Greasewood Compressor Station in Rio Blanco County, Colorado); and • One new meter station, one mainline valve, and associated facilities. Overthrust (Wamsutter Expansion Project) • 77.2 miles of 36-inch-diameter natural gas pipeline in Sweetwater County, Wyoming; • 0.1 mile of 20-inch-diameter pipeline (TL-90 Tie-in); • Two new compressor stations in Wyoming (Roberson Compressor Station in Lincoln County and Rock Springs Compressor Station in Sweetwater County); and • Two new meter stations, three mainline valves, and associated facilities. The final EIS has been placed in the public files of the FERC and is available for distribution and public inspection at: Federal Energy Regulatory Commission, Public Reference Room, 888 First Street, NE., Room 2A, Washington, DC 20426,
(202)502-8371. CD-ROM copies of the final EIS have been mailed to federal, state, and local agencies; public interest groups; individuals and affected landowners who requested a copy of the final EIS or provided comments during scoping; libraries and newspapers in the Project area; and parties to this proceeding. Hard copy versions of the final EIS were mailed to those specifically requesting them. A limited number of hard copies and CD-ROMs are available from the Public Reference Room identified above. Additional information about the project is available from the Commission's Office of External Affairs, at 1-866-208-FERC or on the FERC Internet Web site ( *http://www.ferc.gov* ) using the eLibrary link. Click on the eLibrary link, click on “General Search” and enter the docket number excluding the last three digits in the Docket Number field. Be sure you have selected an appropriate date range. For assistance, please contact FERC Online Support at *FERCOnlineSupport@ferc.gov* or toll free at 1-866-208-3676, or for TTY, contact
(202)502-8659. The eLibrary link on the FERC Internet Web site also provides access to the texts of formal documents issued by the Commission, such as orders, notices, and rulemakings. In addition, the Commission now offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries and direct links to the documents. Go to the eSubscription link on the FERC Internet Web site. Philis J. Posey, Acting Secretary. [FR Doc. E7-5200 Filed 3-21-07; 8:45 am] BILLING CODE 6717-01-P ENVIRONMENTAL PROTECTION AGENCY [FRL-8290-8] Science Advisory Board Staff Office; Notification of Two Public Teleconferences and a Meeting of the Science Advisory Board Integrated Nitrogen Committee AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: The Environmental Protection Agency (EPA or Agency) Science Advisory Board Staff Office announces two public teleconferences and a meeting of the EPA Science Advisory Board Integrated Nitrogen Committee. DATES: The teleconference meetings will be held on Thursday, April 19, 2007, from 3 p.m. to 5 p.m. (Eastern Time) and on June 8, 2007 from 2 p.m. to 4 p.m. (Eastern Time). A face-to-face meeting will be held on June 20, 2007 from 1 p.m. to 5 p.m. (Eastern Time), continuing from 8:30 a.m. to 5 p.m. (Eastern Time) on June 21, and from 8:30 a.m. to 3 p.m. on June 22. ADDRESSES: The teleconferences will be conducted by phone only. The June 20-22, 2007 face-to-face meeting will be held at the SAB Conference Center, located at 1025 F Street, NW., Washington, DC 20004. FOR FURTHER INFORMATION CONTACT: Any member of the public who wishes to obtain the call-in number and access code for the teleconferences; attend the face-to-face meeting; or receive further information concerning the teleconferences and meeting may contact Ms. Kathleen White, Designated Federal Officer (DFO). Ms. White may be contacted at the EPA Science Advisory Board (1400F), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; or via telephone/voice mail:
(202)343-9878; fax:
(202)233-0643; or e-mail at: *white.kathleen@epa.gov* . General information concerning the EPA SAB can be found on the EPA Web site at *http://www.epa.gov/sab* . SUPPLEMENTARY INFORMATION: *Background:* The SAB Integrated Nitrogen Committee is conducting an evaluative study on the need for integrated research and control management strategies. To begin its work, the Committee held a public meeting on January 30-31, 2007, to develop a work plan for the study. Background information on that meeting was provided in a **Federal Register** notice (72 FR 1989, January 17, 2007). On the April 19, 2007 call the Committee will discuss information needs on sources, transport, fate, effects, impacts and metrics relating to reactive nitrogen in the environment; and discuss options for meeting those needs through the literature, committee work, and invited speakers for the face-to-face meeting. On the June 8, 2007 call, members of the Committee will present the information they have developed, make recommendations for refining the agenda, and conduct other Committee business. At the June 20-22, 2007 face-to-face meeting the Committee will complete information gathering for the first phase of its work, relating to sources, transport, fate, effects, impacts and metrics relating to reactive nitrogen in the environment and make appropriate related writing assignments for its report. The Committee will also begin the second phase of its work addressing the relationship of nitrogen to ecosystem scale through case studies. The Committee may undertake other Committee business as needed and time allows. *Availability of Meeting Materials:* The draft agenda, and other materials for this teleconference will be posted on the SAB Web site at *http://epa.gov/sab/panels/ad_hoc_inr_committee.htm* prior to the meeting *Procedures for Providing Public Input:* Interested members of the public may submit relevant written or oral information for the Integrated Nitrogen Committee to consider during the course of their study. *Oral Statements:* In general, individuals or groups requesting an oral presentation at a public teleconference will be limited to three minutes per speaker, with no more than a total of 30 minutes for all speakers. Interested parties should contact Ms. White, DFO, in writing (preferably via e-mail), by April 12, 2007, for the April 19 teleconference, by June 1 for the June 8 teleconference, and by June 13 for the June 20-22 meeting, at the contact information noted above, to be placed on the list of public speakers for this meeting. *Written Statements:* Written statements should be received in the SAB Staff Office by the same dates. Written statements should be supplied to the DFO in the following formats: one hard copy with original signature, and one electronic copy via e-mail (acceptable file format: Adobe Acrobat PDF, WordPerfect, MS Word, MS PowerPoint, or Rich Text files in IBM-PC/Windows 98/2000/XP format). *Accessibility:* For information on access or services for individuals with disabilities, please contact Ms. White at the phone number or e-mail address noted above, preferably at least ten days prior to the meeting, to give EPA as much time as possible to process your request. Dated: March 16, 2007. Anthony F. Maciorowski, Deputy Director, EPA Science Advisory Board Staff Office. [FR Doc. E7-5264 Filed 3-21-07; 8:45 am] BILLING CODE 6560-50-P FEDERAL RESERVE SYSTEM Agency information collection activities: Announcement of Board approval under delegated authority and submission to OMB AGENCY: Board of Governors of the Federal Reserve System. SUMMARY: Background. Notice is hereby given of the final approval of proposed information collection by the Board of Governors of the Federal Reserve System (Board) under OMB delegated authority, as per 5 CFR 1320.16 (OMB Regulations on Controlling Paperwork Burdens on the Public). Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the Paperwork Reduction Act Submission, supporting statements and approved collection of information instrument(s) are placed into OMB's public docket files. The Federal Reserve 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. FOR FURTHER INFORMATION CONTACT: Federal Reserve Board Clearance Officer --Michelle Shore--Division of Research and Statistics, Board of Governors of the Federal Reserve System, Washington, DC 20551 (202-452-3829). OMB Desk Officer--Mark Menchik--Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503, or e-mail to mmenchik@omb.eop.gov. Final approval under OMB delegated authority of the extension for three years, with revision, of the following reports *1. Report title:* Weekly Report of Assets and Liabilities for Large Banks and Weekly Report of Selected Assets *Agency form number:* FR 2416 and FR 2644 *OMB Control number:* 7100-0075 *Frequency:* Weekly *Reporters:* U.S.-chartered commercial banks *Annual reporting hours:* FR 2416, 22,386 hours; FR 2644, 80,652 hours *Estimated average hours per response:* FR 2416, 8.61 hours; FR 2644, 1.41 hours *Number of respondents:* FR 2416, 50; FR 2644, 1,100 *General description of report:* These information collections are voluntary [12 U.S.C. § 225(a) and 248(a)(2)]. Individual respondent data are regarded as confidential under the Freedom of Information Act [5 U.S.C. § 552(b)(4)]. *Abstract:* The FR 2416, FR 2644, and the Weekly Report of Assets and Liabilities for Large U.S. Branches and Agencies of Foreign Banks (FR 2069; OMB No. 7100-0030) are referred to collectively as the bank credit reports. The FR 2416 is a detailed balance sheet that covers domestic offices of large U.S.-chartered commercial banks. The FR 2644 collects less-detailed information on investments, loans, total assets, and several memoranda items, covering domestic offices of small U.S.-chartered commercial banks. The bank credit reports are collected as of each Wednesday. These three voluntary reports are mainstays of the Federal Reserve's reporting system from which data for analysis of current banking developments are derived. The FR 2416 is used on a stand-alone basis as the large domestic bank series. The FR 2644 collects sample data, which are used to estimate universe levels using data from the quarterly commercial bank Consolidated Reports of Condition and Income (FFIEC 031 and 041; OMB No. 7100-0036) (Call Report). Data from the bank credit reports, together with data from other sources, are used for constructing weekly estimates of bank credit, of sources and uses of bank funds, and of a balance sheet for the banking system as a whole. The Federal Reserve publishes the data in aggregate form in the weekly H.8 statistical release, *Assets and Liabilities of Commercial Banks in the United States* , which is followed closely by other government agencies, the banking industry, the financial press, and other users. This release provides a balance sheet for the banking industry as a whole and data disaggregated by its large domestic, small domestic, and foreign-related components. *Current Actions:* On January 11, 2007, the Federal Reserve published a notice in the Federal Register (72 FR 1325) requesting public comment for 60 days on the extension, with revision, of the FR 2416 and FR 2069. The comment period for this notice expired on March 12, 2007. The Federal Reserve received one supportive comment letter from a federal agency describing its use of the data to prepare monthly, quarterly, and annual estimates of personal interest payments, a component of personal outlays in the national income and product accounts. *2. Report title:* Weekly Report of Assets and Liabilities for Large U.S. Branches and Agencies of Foreign Banks *Agency form number:* FR 2069 *OMB Control number:* 7100-0030 *Frequency:* Weekly *Reporters:* U.S. branches and agencies of foreign banks *Annual reporting hours:* 14,560 hours *Estimated average hours per response:* 4.00 hours *Number of respondents:* 70 *General description of report:* This information collection is voluntary [12 U.S.C. §§ 248(a)(2) and 3105(a)(2)]. Individual respondent data are regarded as confidential under the Freedom of Information Act [5 U.S.C. § 552(b)(4)]. *Abstract:* The FR 2069 is a detailed balance sheet that covers large U.S. branches and agencies of foreign banks. This report, along with the FR 2416 and FR 2644, is collected as of each Wednesday. These three voluntary reports are mainstays of the Federal Reserve's reporting system from which data for analysis of current banking developments are derived. The FR2069 collects sample data, which are used to estimate universe levels using data from the quarterly Report of Assets and Liabilities of U.S. Branches and Agencies of Foreign Banks (FFIEC 002; OMB No. 7100-0032). Data from the bank credit reports, together with data from other sources, are used for constructing weekly estimates of bank credit, of sources and uses of bank funds, and of a balance sheet for the banking system as a whole. The Federal Reserve publishes the data in aggregate form in the weekly H.8 statistical release, *Assets and Liabilities of Commercial Banks in the United States* , which is followed closely by other government agencies, the banking industry, the financial press, and other users. This release provides a balance sheet for the banking industry as a whole and data disaggregated by its large domestic, small domestic, and foreign-related components. *Current Actions:* On January 11, 2007, the Federal Reserve published a notice in the Federal Register (72 FR 1325) requesting public comment for 60 days on the extension, with revision, of the FR 2069. The comment period for this notice expired on March 12, 2007. The Federal Reserve did not receive any comments. *3. Report titles:* Report of Changes in Organizational Structure, Annual Report of Bank Holding Companies *Agency form numbers:* FR Y-10 and FR Y-6 *OMB Control numbers:* 7100-0297 *Effective Dates:* FR Y-6, December 31, 2007; FR Y-10, April 30, 2008 *Frequency:* Event-generated, annual *Reporters:* Bank holding companies (BHCs), foreign banking organizations (FBOs), member banks, Edge and agreement corporations *Annual reporting hours:* FR Y-10, 16,608 hours; FR Y-6, 27,069 hours *Estimated average hours per response:* FR Y-10, 1.00 hour; FR Y-6, 5.25 hours; *Number of respondents:* FR Y-10, 2,768; FR Y-6, 5,156 *General description of report:* These information collections are mandatory under the Federal Reserve Act, the BHC Act, and the International Banking Act (12 U.S.C. 248 (a)(1), 321, 601, 602, 611a, 615, 1843(k), 1844(c), and 3106, and Regulations K and Y (12 CFR 211.13(c), 225.5(b), and 225.87). Individual respondent data are not considered confidential. However, respondents may request confidential treatment for any information that they believe is subject to an exemption from disclosure under the FOIA, 5 U.S.C. § 552(b). *Abstract:* The FR Y-10 is an event-generated information collection submitted by top-tier domestic BHCs, including financial holding companies (FHCs), and state member banks unaffiliated with a BHC, to capture changes in their regulated investments and activities. The Federal Reserve uses the data to monitor structure information on subsidiaries and regulated investments of these entities engaged in banking and nonbanking activities. The FR Y-6 is an annual information collection submitted by top-tier BHCs and nonqualifying FBOs. It collects financial data, an organization chart, and information about shareholders. The Federal Reserve uses the data to monitor holding company operations and determine holding company compliance with the provisions of the BHC Act and Regulation Y (12 CFR 225). *Current Actions:* On September 13, 2006, the Federal Reserve published a notice in the Federal Register (71 FR 54075) requesting public comment for 60 days on the extension, with revision, of the Structure Reports. 1 The comment period for this notice expired on November 13, 2006. The Board received comment letters from four large BHCs and three industry trade associations. Most of these comments were addressed in a final Federal Register notice dated December 28, 2006 (71 FR 78207). In this notice, the Federal Reserve stated that it was continuing to evaluate several substantive comments on the collection of domestic branch data and would address these comments in a separate Federal Register notice in 2007. Below is a summary of the original proposal, a summary of the comments received, and the modifications to the original proposal. 1 The Structure Reports included in the initial notice were the Report of Changes in Organizational Structure (FR Y-10), the Report of Changes in FBO Organizational Structure (FR Y-10F), the Supplement to the Report of Changes in Organizational Structure (FR Y-10S), the Notification of Foreign Branch Status (FR 2058), the Annual Report of Bank Holding Companies (FR Y-6), and the Annual Report of Foreign Banking Organizations (FR Y-7). Original Proposal **FR Y-6 Organization Chart** The Federal Reserve proposed to add to the organization chart an annual requirement for institutions to verify a list of domestic branches that the Federal Reserve has on file for the institution. The list of domestic branches would include those of depository institutions and Edge and agreement corporations held directly or indirectly by the respondent. The Federal Reserve would provide institutions with a hardcopy of their data and, in response to industry feedback, a means for institutions to download their data in a spreadsheet format. The institutions would be required to return to the Federal Reserve an annotated document incorporating any changes or corrections to the data. The effective date for this proposed change would have been December 31, 2006. **FR Y-10 Domestic Branch Schedule** The Federal Reserve proposed to add a schedule to collect data on domestic branches and offices of depository institutions, held directly or indirectly, and domestic branches of Edge and agreement corporations. Data regarding branch openings, acquisitions, sales, closings or relocations would be collected on an event-generated basis, parallel to the other schedules on the FR Y-10, within thirty calendar days following the event. Institutions would be permitted to combine multiple transactions occurring within a 30-day period into a single monthly filing. The effective date for this proposed change would have been June 30, 2007. Data would be submitted for the following branches and offices: 1. Full service (brick and mortar, retail) - traditional offices. 2. Electronic banking - offices where Internet and other similar deposits are booked. 3. Limited service (military, drive-through, mobile or seasonal, and retail) - limited, but often take or include deposits. 4. Loan production offices
(LPOs)and consumer credit - limited, normally nondeposit, but extend credit. 5. Trust - limited and nondeposit 6. Administrative (administrative, contractual, messenger) - all other limited and nondeposit Summary of Comments Several commenters indicated that adding a schedule to the FR Y-10 to collect data on domestic branches would be overly burdensome and may be duplicative of other information collected by the Federal Reserve or other regulators. As explained in the initial proposal, the current process for gathering domestic branch structure data is inadequate. Branch data for domestic state member banks are communicated to the Federal Reserve primarily through the application process. Information for all other domestic bank branches (branches of national and nonmember banks) is obtained by searching Federal Deposit Insurance Corporation
(FDIC)and Office of the Comptroller of the Currency
(OCC)bulletins. The results of this process are data that are not consistent and are often stale. The timing and extent of notifications to various bank regulators do not allow for consistent maintenance of the data. For example, branch openings and closings are reported with different lags and through different channels. Also, domestic bank branch data are submitted to the FDIC on the Summary of Deposits (OMB No. 3064-0061) as of June 30 each year. 2 However, the volume of branch structure changes is large. As a result, the relevancy of the annual data substantially diminishes over time. The Federal Reserve needs a formal information collection to ensure that these data are consistent, complete, and current. 2 Thrift branches are reported as of June 30 each year to the OTS, on their annual Branch Office Survey (OMB No. 1550-0004). One commenter questioned the usefulness of the data, since only institutions regulated by the Federal Reserve would be required to submit the data. This commenter noted that the data would be incomplete for analyzing the competitive effects of proposed bank mergers and acquisitions in specific markets. As described in the original proposal, 95 percent of all domestic banking branches and 82 percent of all banking and thrift branches would be covered by this information collection. Information for the remaining small percentage of branches would continue to be collected using the current process for gathering domestic branch structure data discussed above. Although the information for these branches will not be as reliable as that obtained from the FR Y-10 respondents, the overall quality of the branch data will be dramatically improved by this framework. Several commenters asked the Federal Reserve to coordinate with the other agencies to collect consistent structure data. The Federal Reserve acknowledges that coordination with other agencies could achieve organizational and technical efficiencies for both banking organizations and the regulatory community. The Federal Reserve has been in contact with the other agencies during the development of this proposal. Discussions among the regulatory agencies regarding possible gains from coordination, as well as changes and enhancements to the technological platforms used for the collection are ongoing. Two commenters requested amending the information collection to allow respondents to provide their complete list of branches monthly on a separate report rather than providing changes on an event-generated basis on the FR Y-10. The Federal Reserve believes that the data would be more accurately and efficiently collected if banking organizations submit changes directly to the Federal Reserve, rather than requiring Federal Reserve staff to discern changes by comparing monthly filings. Furthermore, relative to existing branches, the number of branch openings, closings, sales, and relocations is quite small. The current proposal allows for greater flexibility in how the schedule is filed, which should allow banks to find efficient ways to transmit the data. One commenter requested clarification of the administrative branch type. This term was defined in the draft instructions as a branch that has limited nondeposit functions, including back office operations and check processing facilities. Modifications to the Original Proposal In response to comments and industry feedback, the Federal Reserve approved the following modifications to the original proposal: • Eliminating LPOs, consumer credit offices, and administrative offices from the list of reportable branches on the FR Y-6 and FR Y-10; • Excluding from the FR Y-10 address changes that result from changes in street names or zip codes, with no actual change in the physical location of the branch; • Making FR Y-10 reporting of branch relocations of less than 1,000 feet optional, if the move does not involve a change of county; and • Changing the implementation dates to December 31, 2007, for the FR Y-6 revisions and April 30, 2008, for the FR Y-10 revisions. Final approval under OMB delegated authority the implementation of the following survey: *Report title:* Central Bank Survey of Foreign Exchange and Derivatives Market Activity *Agency form number:* FR 3036 *OMB control number:* 7100-0285 *Frequency:* One-time *Reporters:* Financial institutions that serve as intermediaries in the wholesale foreign exchange and derivatives market and dealers. *Annual reporting hours:* 3,150 hours *Estimated average hours per response:* Turnover survey: 51 hours; outstandings survey: 60 hours *Number of respondents:* 60 *General description of report:* This information collection is voluntary (12 U.S.C. 225a, 248(a)(2), 358, and 3105(c)) and is given confidential treatment (5 U.S.C. § 552(b)(4)). *Abstract:* The FR 3036 is the U.S. part of a global data collection that is conducted by central banks every three years. More than fifty central banks plan to conduct the survey in 2007. The Bank for International Settlements compiles national data from each central bank to produce global market statistics. The Federal Reserve System and other government agencies use the survey to monitor activity in the foreign exchange and derivatives markets. Respondents use the published data to gauge their market share. *Current actions:* On January 11, 2007, the Federal Reserve published a notice in the Federal Register (72 FR 1325) requesting public comment for 60 days on the implementation of the FR 3036 survey. The comment period for this notice expired on March 12, 2007. The Federal Reserve received no comments on the proposed survey and will implement it as proposed. Board of Governors of the Federal Reserve System, March 16, 2007. Jennifer J. Johnson Secretary of the Board [FR Doc. E7-5192 Filed 3-21-07; 8:45 am] BILLING CODE 6210-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-07-05CO] Proposed Data Collections Submitted for Public Comment and Recommendations 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 Centers for Disease Control and Prevention
(CDC)will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-5960 and send comments to Joan F. Karr, CDC Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to *omb@cdc.gov.* Comments are invited on:
(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;
(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;
(c)ways to enhance the quality, utility, and clarity of the information to be collected; and
(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice. Notice of Republication of 60 day FRN Title of Project Evaluation of the Centers for Disease Control and Prevention's Consumer Response Service Center—New—National Center for Healthcare Marketing (NCHM), Centers for Disease Control and Prevention (CDC). Description of Republication Due to expiration of the 60Day-05-05CO on July 21, 2005 OMB Desk Officer (John Kraemer) has requested that the 60Day-07-05CO be republished using the date of 02/15/2007, which is currently the 30Day-07-05CO publication date. Public comments will be considered until COB of April 15, 2007. We are working to put measures in place to ensure this does not happen again. The 30 day FRN will be republished at a later date. Background and Brief Description CDC is launching an integrated “one face to the public” approach across all communication channels to handle inquiries concerning a broad spectrum of public health topics. The overall objective is to ensure consistent, timely, reliable health information for dissemination to a variety of consumers (public, health professionals, researchers, etc.) and to address variations in inquiry volumes related to public health emergencies, news events, and dynamic, shifting public health priorities. The CDC has integrated over 40 hotlines into one Consumer Response Services Center—CDC-INFO. CDC-INFO has an exceptionally wide scope because content currently divided between over 40 hotlines handling nearly 2,000,000 telephone contacts annually will be consolidated under CDC-INFO. All CDC hotlines were consolidated in one center beginning in February 2005, with all CDC program areas transitioning into CDC-INFO through a phased approach during the next three years. CDC-INFO itself will be operational for at least the next seven years. The primary objectives of the national evaluation are to
(1)Proactively evaluate customer interactions and service effectiveness by employing assessment measures and data collection mechanisms to support performance management, gathering insights and understandings for improving service levels, and implementing effective measures to meet customer satisfaction goals;
(2)develop an ongoing understanding of customer requirements and satisfaction trends to achieve best of practice quality standards and to provide qualitative assessments, quantitative data, and cost factors to drive improvement and reinforce operational objectives;
(3)measure CDC-INFO contractor service performance to assist in determining whether performance incentives have been achieved; and
(4)to collect data in order to address public concern and response to emergencies, outbreaks, and media events. Sample size, respondent burden, and intrusiveness have been minimized to be consistent with national evaluation objectives. Procedures will be employed to safeguard the privacy and confidentiality of participants. Pilot tests assisted in controlling burden and ensuring the user-relevance of questions. The following table shows the estimated annualized burden for data collection. There are no respondent costs other than the amount of time required to respond to the survey. *Estimated Annualized Burden Hours:* Data collection instrument Number of respondents Responses /respondent Average burden per response (in hrs) Average annual burden hours Satisfaction survey (callers) 25,000 1 3/60 1,250 Satisfaction survey (e-mail inquiries) 330 1 3/60 17 Follow up survey 3,125 1 7/60 365 Key informant survey 100 1 7/60 12 Postcard survey for bulk mailing 950 1 1/60 16 Postcard survey for individual publications 2,100 1 1/60 35 Web survey for e-mail publication orders 1,000 1 1/60 17 Web survey for internet publications 950 1 1/60 16 Special event/Outreach survey—General Public 25,600 1 5/60 2,133 Special event/Outreach survey—Professionals 10,400 1 5/60 867 Emergency response survey—Level 1 emergency—General Public 31,151 1 5/60 2596 Emergency response survey—Level 1 emergency—Professionals 7,459 1 5/60 622 Emergency response survey—Level 2 emergency—General Public 57,579 1 5/60 4798 Emergency response survey—Level 2 emergency—Professionals 51,821 1 5/60 4318 Emergency response survey—Level 3 emergency—General Public 351,863 1 5/60 29,322 Emergency response survey—Level 3 emergency—Professional 316,678 1 5/60 26,390 Emergency response survey—Level 4 emergency—General Public 645,630 1 5/60 53,803 Emergency response survey—Level 4 emergency—Professional 596,504 1 5/60 49,709 Total Burden Hours 176,286 Dated: March 15, 2007. Deborah Holtzman, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E7-5218 Filed 3-21-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket Number NIOSH 101] A Public meeting to provide input regarding the draft document, “Long-Term Field Evaluation
(LTFE)Program Concept” AGENCY: National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice of public meeting. *Meeting Date and Time:* March 22, 2007, 9 a.m.-4 p.m. *Place:* DoubleTree Pittsburgh Airport Hotel, 8402 University Blvd., Moon Township, PA 15108. SUMMARY: The National Institute for Occupational Safety and Health (NIOSH) announces the availability of opportunity for the public to provide input regarding the draft document, “Long-Term Field Evaluation
(LTFE)Program Concept.” The public meeting will be held on March 22, 2007 at the DoubleTree Pittsburgh Airport Hotel, 8402 University Blvd., Moon Township, PA 15108. NIOSH is the Federal agency responsible for conducting research and making recommendations for the approval for self-contained, self-rescuer
(SCSR)closed circuit escape respirators, Title 42, Code of Federal Regulations (CFR), Part 84. The LTFE program for self-contained self-rescuers (SCSRs) for miners was initiated more than 20 years ago by the U.S. Bureau of Mines. The objective for the LTFE program is to obtain data to determine the expected performance characteristics of SCSRs used in the mining industry. LTFE program results based on scientific principles can provide useful information to monitor expected SCSR performance and assess possible degradation due to the physical stresses of in-mine use. Of utmost concern is the successful performance of any SCSR that passes its inspection criteria specified by the manufacturer. It is such an apparatus that must be relied upon in an emergency. A copy of the draft document can be found at: *http://www.cdc.gov/niosh/review/public/NPPTL-LTFE/.* ADDRESSES: Comments should be submitted to the NIOSH Docket Office, Robert A. Taft Laboratories, 4676 Columbia Parkway. M/S C-34, Cincinnati, OH 45226, telephone 513/533-8450, fax 513/533-8285. Comments may also be submitted directly at *http://www.cdc.gov/niosh/review/public/NPPTL-LTFE/.* The document will remain available for comment until April 5, 2007. Comments should reference docket number NIOSH-101 in the subject heading. All information received in response to this notice will be available for public examination and copying at the NIOSH Docket Office, Room 111, 4676 Columbia Parkway, Cincinnati, Ohio 45226. *Contact Person for Technical Information:* Les Boord, NIOSH Director for National Personal Protective Technology Laboratory, 626 Cochrans Mill Road, P.O. Box 18070, Pittsburgh, PA 15236. Dated: March 15, 2007. James D. Seligman, Chief Information Officer, Centers for Disease Control and Prevention. [FR Doc. E7-5216 Filed 3-21-07; 8:45 am] BILLING CODE 4163-19-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Institute for Occupational Safety and Health (NIOSH); Advisory Board on Radiation and Worker Health (ABRWH or Advisory Board), Subcommittee for Dose Reconstruction Reviews
(SDRR)In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention announces the following meeting of the aforementioned subcommittee: *Subcommittee Meeting Time and Date:* 10 a.m.-5 p.m., April 11, 2007. *Place:* Cincinnati Airport Marriott, 2395 Progress Drive, Hebron, KY 41018. Phone 859.334.4611, Fax 859.334.4619. *Conference Call Access:* Phone 866.643.6504, Participant Pass Code 9448550. *Status:* Open to the public. *Background:* The Advisory Board was established under the Energy Employees Occupational Illness Compensation Program Act of 2000 to advise the President on a variety of policy and technical functions required to implement and effectively manage the new compensation program. Key functions of the Advisory Board include providing advice on the development of probability of causation guidelines that have been promulgated by the Department of Health and Human Services
(HHS)as a final rule, advice on methods of dose reconstruction which have also been promulgated by HHS as a final rule, advice on the scientific validity and quality of dose estimation and reconstruction efforts being performed for purposes of the compensation program, and advice on petitions to add classes of workers to the Special Exposure Cohort. In December 2000, the President delegated responsibility for funding, staffing, and operating the Advisory Board to HHS, which subsequently delegated this authority to CDC. NIOSH implements this responsibility for CDC. The charter was issued on August 3, 2001, renewed at appropriate intervals, and will expire on August 3, 2007. *Purpose:* The Advisory Board is charged with
(a)Providing advice to the Secretary, HHS, on the development of guidelines under Executive Order 13179;
(b)providing advice to the Secretary, HHS, on the scientific validity and quality of dose reconstruction efforts performed for this program; and
(c)upon request by the Secretary, HHS, providing advice to the Secretary on whether there is a class of employees at any Department of Energy facility who were exposed to radiation but for whom it is not feasible to estimate their radiation dose, and on whether there is reasonable likelihood that such radiation doses may have endangered the health of members of this class. *Matters To Be Discussed:* Need for Basic vs. Advanced Reviews; How to Conduct Blind Reviews; Status of Individual Dose Reconstruction Audits; Planning Future Dose Reconstruction Audits; and Assignment of Two Board Member Teams to Oversee Audit Process. The agenda is subject to change as priorities dictate. There is no public comment period, however, written comments may be submitted. Any written comments received will be provided at the meeting and should be submitted to the contact person below well in advance of the meeting. *Contact Person for Further Information:* Dr. Lewis V. Wade, Executive Secretary, NIOSH, CDC, 4676 Columbia Parkway, Cincinnati, OH 45226, Telephone 513.533.6825, Fax 513.533.6826. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7-5225 Filed 3-21-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention Announces the Following: Implementation of New Record Schedule AGENCY: Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice. SUMMARY: NIOSH is implementing a new record schedule governing the retention of records transferred to the agency by employers pursuant to the regulations of the Occupational Safety and Health Administration (OSHA). Pursuant to this schedule, NIOSH will review these records to determine if they document exposures or medical conditions as required under the OSHA regulations and have research value. Those records that NIOSH determines meet the OSHA regulations and have a research value will be retained for 30 years. Those records that do not document exposure or medical condition and treatment or have no research value will not be retained. SUPPLEMENTARY INFORMATION: The hazard-specific standards of the Occupational Safety and Health Administration (OSHA)(Title 29, Code of Federal Regulations [CFR], Parts 1910.1001 through 1910.1450) contain requirements stating that when a company closes and leaves no successor employer, it must transfer (or in some instances, offer to transfer) its employee's medical and exposure records to NIOSH. The OSHA carcinogens standards (29 CFR 1910.1003-1910.1016) also require that such records be transferred to NIOSH when an employee resigns, retires, or dies. The transfer of these records to NIOSH is intended to preserve them for research purposes. NIOSH has amended its record schedule pertaining to these records, *Employee Exposure and Medical Records (NIOSH), (NARA job Number N1-442-98-1, Item 2), Item 2-80 in the CDC Records Control Schedule
(RCS)B-321* , to reduce the retention period of those records and permit the destruction of the records which do not serve any research purpose. Under the new schedule, those records that meet the requirements of the OSHA regulations and serve a research purpose will now be retained for 30 years, rather than 40 years (as under the previous record schedule). However, if upon review NIOSH determines that the records are not medical records or exposure records required to be transferred to NIOSH or were not systematically collected and will not serve a research purpose, the records will not be retained and will be destroyed. On September 16, 2005, the National Archives and Records Administration
(NARA)published in the **Federal Register** [70(179):54774-54776] a notice of availability of this proposed record schedule, Employee Exposure and Medical Records (NIOSH), (NARA job number N1-442-2005-1, Item 1) and request for comments. Following receipt and review of comments, NARA approved this revised record schedule on December 16, 2005. This notice announces adoption of the revised schedule by NIOSH. A copy of the revised record schedule can be obtained from NIOSH. FOR FURTHER INFORMATION CONTACT: Rodger Tatken, National Institute for Occupational Safety and Health, Robert A. Taft Laboratories, 4676 Columbia Parkway, Cincinnati, OH 45226
(513)533-8370. Dated: March 14, 2007. James D. Seligman, Chief Information Officer, Center for Disease Control and Prevention. [FR Doc. E7-5219 Filed 3-21-07; 8:45 am] BILLING CODE 4163-19-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0092] Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Food and Drug Administration Rapid Response Surveys 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 use of rapid response surveys to obtain data on safety information to support quick-turnaround decisionmaking about potential safety problems or risk management solutions from health care professionals, hospitals and other user-facilities (e.g., nursing homes, etc.); consumers; manufacturers of biologics, drugs, and medical devices; distributors; and importers when FDA must quickly determine whether or not a problem with a biologic, drug, or medical device impacts the public health. DATES: Submit written or electronic comments on the collection of information by May 21, 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. Generic Food and Drug Administration Rapid Response Surveys (OMB Control Number 0910-0500)—Extension Section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355), requires that important safety information relating to all human prescription drug products be made available to FDA so that it can take appropriate action to protect the public health when necessary. Section 702 of the act (21 U.S.C. 372) authorizes investigational powers to FDA for enforcement of the act. Under section 519 of the act (21 U.S.C. 360i), FDA is authorized to require manufacturers to report medical device-related deaths, serious injuries, and malfunctions to FDA; to require user facilities to report device-related deaths directly to FDA and to manufacturers; and to report serious injuries to the manufacturer. Section 522 of the act (21 U.S.C. 360l) authorizes FDA to require manufacturers to conduct postmarket surveillance of medical devices. Section 705(b) of the act (21 U.S.C. 375(b)) authorizes FDA to collect and disseminate information regarding medical products or cosmetics in situations involving imminent danger to health or gross deception of the consumer. Section 903(d)(2) of the act (21 U.S.C. 393(d)(2)) authorizes the Commissioner of Food and Drugs to implement general powers (including conducting research) to carry out effectively the mission of FDA. These sections of the act enable FDA to enhance consumer protection from risks associated with medical products usage that are not foreseen or apparent during the premarket notification and review process. FDA's regulations governing application for agency approval to market a new drug (21 CFR part 314) and regulations governing biological products (21 CFR part 600) implement these statutory provisions. Currently FDA monitors medical product related postmarket adverse events via both the mandatory and voluntary MedWatch reporting systems using FDA Forms 3500 and 3500A (OMB control number 0910-0291) and the vaccine adverse event reporting system. FDA is seeking OMB clearance to collect vital information via a series of rapid response surveys. Participation in these surveys will be voluntary. This request covers rapid response surveys for community based health care professionals, general type medical facilities, specialized medical facilities (those known for cardiac surgery, obstetrics/gynecology services, pediatric services, etc.), other health care professionals, patients, consumers, and risk managers working in medical facilities. FDA will use the information gathered from these surveys to obtain quickly vital information about medical product risks and interventions to reduce risks so the agency may take appropriate public health or regulatory action including dissemination of this information as necessary and appropriate. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 200 30 6,000 .5 3,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information. FDA projects 30 emergency risk related surveys per year with a sample of between 50 and 200 respondents per survey. FDA also projects a response time of 0.5 hours per response. These estimates are based on the maximum sample size per questionnaire that FDA can analyze in a timely manner. The annual frequency of response was determined by the maximum number of questionnaires that will be sent to any individual respondent. Some respondents may be contacted only one time per year, while other respondents may be contacted several times annually, depending on the human drug, biologic, or medical device under evaluation. It is estimated that, given the expected type of issues that will be addressed by the surveys, it will take 0.5 hours for a respondent to gather the requested information and fill in the answers. Dated: March 15, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-5195 Filed 3-21-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0527] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Threshold of Regulation for Substances Used in Food-Contact Articles AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing that a 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 April 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. 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. Threshold of Regulation for Substances Used in Food-Contact Articles (OMB Control Number 0910-0298)—Extension Under section 409(a) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 348(a)), the use of a food additive is deemed unsafe unless one of the following is applicable:
(1)It conforms to an exemption for investigational use under section 409(j) of the act,
(2)it conforms to the terms of a regulation prescribing its use, or
(3)in the case of a food additive which meets the definition of a food-contact substance in section 409(h)(6) of the act, there is either a regulation authorizing its use in accordance with section 409(a)(3)(A) or an effective notification in accordance with section 409(a)(3)(B). The regulations in § 170.39 (21 CFR 170.39) established a process that provides the manufacturer with an opportunity to demonstrate that the likelihood or extent of migration to food of a substance used in a food-contact article is so trivial that the use need not be the subject of a food additive listing regulation or an effective notification. The agency has established two thresholds for the regulation of substances used in food-contact articles. The first exempts those substances used in food-contact articles where the resulting dietary concentration would be at or below 0.5 part per billion (ppb). The second exempts regulated direct food additives for use in food-contact articles where the resulting dietary exposure is 1 percent or less of the acceptable daily intake for these substances. In order to determine whether the intended use of a substance in a food-contact article meets the threshold criteria, certain information specified in § 170.39(c) must be submitted to FDA. This information includes the following components:
(1)The chemical composition of the substance for which the request is made,
(2)detailed information on the conditions of use of the substance,
(3)a clear statement of the basis for the request for exemption from regulation as a food additive,
(4)data that will enable FDA to estimate the daily dietary concentration resulting from the proposed use of the substance,
(5)results of a literature search for toxicological data on the substance and its impurities, and
(6)information on the environmental impact that would result from the proposed use. FDA uses this information to determine whether the food-contact article meets the threshold criteria. Respondents to this information collection are individual manufacturers and suppliers of substances used in food-contact articles (i.e., food packaging and food processing equipment) or of the articles themselves. In the **Federal Register** of January 8, 2007 (72 FR 792), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. 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 170.39 15 1 15 48 720 1 There are no capital costs or operating and maintenance costs associated with this collection of information. In compiling these estimates, FDA consulted its records of the number of regulation exemption requests received in the past 3 years. The annual hours per response reporting estimate is based on information received from representatives of the food packaging and processing industries and agency records. FDA estimates that approximately 15 requests per year will be submitted under the threshold of regulation exemption process of § 170.39. The threshold of regulation process offers one advantage over the premarket notification process for food-contact substances established by section 409(h) of the act (OMB control number 0910-0495) in that the use of a substance exempted by the agency is not limited to only the manufacturer or supplier who submitted the request for an exemption. Other manufacturers or suppliers may use exempted substances in food-contact articles as long as the conditions of use (e.g., use levels, temperature, type of food contacted, etc.) are those for which the exemption was issued. As a result, the overall burden on both the agency and the regulated industry would be significantly less in that other manufacturers and suppliers would not have to prepare, and FDA would not have to review, similar submissions for identical components of food-contact articles used under identical conditions. Manufacturers and other interested persons can easily access an up-to-date list of exempted substances which is on display at FDA's Division of Dockets Management and on the Web site at *http://www.cfsan.fda.gov* . Having the list of exempted substances publicly available decreases the likelihood that a company would submit a food additive petition or a notification for the same type of food-contact application of a substance for which the agency has previously granted an exemption from the food additive listing regulation requirement. Dated: March 15, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-5196 Filed 3-21-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Request for Nominations for Voting Members on Public Advisory Committees AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is requesting nominations for voting members to serve on the Allergenic Products Advisory Committee, Blood Products Advisory Committee, Cellular, Tissue and Gene Therapies Advisory Committee, Transmissible Spongiform Encephalopathies Advisory Committee, and the Vaccines and Related Biological Products Advisory Committee in the Center for Biologics Evaluation and Research (CBER). Nominations will be accepted for vacancies that will or may occur through January 31, 2008. FDA has a special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on advisory committees, and therefore, encourages nominations of qualified candidates from these groups. DATES: Because scheduled vacancies occur on various dates throughout each year, no cutoff date is established for the receipt of nominations. However, when possible, nominations should be received 6 months before the date of scheduled vacancies for each year, as indicated in this notice. ADDRESSES: All nominations and curricula vitae should be sent to the contact person listed in the FOR FURTHER INFORMATION CONTACT section of this document. FOR FURTHER INFORMATION CONTACT: Donald Jehn, Division of Scientific Advisors and Consultants, Center for Biologics Evaluation and Research (HFM-71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-0314, e-mail: *donald.jehn@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: FDA is requesting nominations of voting members with appropriate expertise for vacancies listed below: **Table** 1. Advisory Committee and Expertise Needed to Fill Vacancies No. of Vacancies Approximate Date Members are Needed Allergenic Products Advisory Committee—allergy, immunology, pediatrics, internal medicine, biochemistry, statistics, and related scientific fields 2 As soon as possible 2 August 31, 2007 Blood Products Advisory Committee—clinical and administrative medicine, hematology, immunology, blood banking, surgery, internal medicine, biochemistry, engineering, statistics, biological and physical sciences, biotechnology, computer technology, epidemiology, consumer advocacy, sociology/ethics, clinical trials, behavioral science, risk communication and other related professions 2 September 30, 2007 Cellular, Tissue, and Gene Therapies Advisory Committee—cellular therapies, tissue transplantation, gene transfer therapies and xenotransplantation including biostatistics, bioethics, hematology/oncology, human tissues and transplantation, reproductive medicine, general medicine and various medical specialties including surgery and oncology, immunology, virology, molecular biology, cell biology, developmental biology, tumor biology, biochemistry, rDNA technology, nuclear medicine, gene therapy, infectious diseases, and cellular kinetics 1 March 31, 2007 Transmissible Spongiform Encephalopathies Advisory Committee—clinical and administrative medicine, hematology, virology, neurovirology, neurology, infectious diseases, immunology, transfusion medicine, surgery, internal medicine, biochemistry, biostatistics, epidemiology, biological and physical sciences, consumer advocacy, sociology/ethics, and other related professions 4 As soon as possible 3 January 31, 2008 Vaccines and Related Biological Products Advisory Committee—immunology, molecular biology, rDNA, virology, bacteriology, epidemiology, biostatistics, allergy, preventive medicine, infectious diseases, pediatrics, microbiology, biochemistry, and other related scientific fields 3 As soon as possible 5 January 31, 2008 I. Functions A. Allergenic Products Advisory Committee The committee reviews and evaluates available data concerning the safety, effectiveness, and adequacy of labeling of marketed and investigational allergenic biological products or materials that are administered to humans for the diagnosis, prevention, or treatment of allergies and allergic diseases. B. Blood Products Advisory Committee The committee reviews and evaluates available data concerning the safety, effectiveness, and appropriate use of blood and products derived from blood and serum or biotechnology which are intended for use in the diagnosis, prevention, or treatment of human diseases. C. Cellular, Tissue and Gene Therapies Advisory Committee The committee reviews and evaluates available data relating to the safety, effectiveness, and appropriate use of human cells, human tissues, gene transfer therapies and xenotransplantation products which are intended for transplantation, implantation, infusion and transfer in the prevention and treatment of a broad spectrum of human diseases and in reconstruction, repair, or replacement of tissues for various conditions. D. Transmissible Spongiform Encephalopathies Advisory Committee The committee reviews and evaluates available scientific data concerning the safety of products which may be at risk for transmission of spongiform encephalopathies having an impact on the public health. E. Vaccines and Related Biological Products Advisory Committee The committee reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases. II. Qualifications Persons nominated for membership on the committees shall have adequately diversified experience appropriate to the work of the committee in such fields as clinical and administrative medicine, engineering, biological and physical sciences, statistics, and other related professions. The nature of specialized training and experience necessary to qualify the nominee as an expert suitable for appointment may include experience in medical practice, teaching, and/or research relevant to the field of activity of the committee. The particular need for vacancies on each committee through January 31, 2008, is shown in Table 1 of this document. The term of office is up to 4 years, depending on the appointment date. III. Nomination Procedures Any interested person may nominate one or more qualified persons for membership on one or more of the advisory committees. Self-nominations are also accepted. Nominations shall include the name of the committee, a complete curriculum vitae of each nominee, current business address and telephone number, and shall state that the nominee is aware of the nomination, is willing to serve as a member (name of committee(s) must be specified), and appears to have no conflict of interest that would preclude membership. FDA will ask the potential candidates to provide detailed information concerning such matters as financial holdings, employment, and research grants and/or contracts to permit evaluation of possible sources of conflict of interest. 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: March 14, 2007. Randall W. Lutter, Associate Commissioner for Policy. [FR Doc. E7-5193 Filed 3-21-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. *Name of Committee* : Pulmonary-Allergy Drugs Advisory Committee. *General Function of the Committee* : To provide advice and recommendations to the agency on FDA's regulatory issues. *Date and Time* : The meeting will be held on May 1, 2007, from 8 a.m. to 5:30 p.m. *Location* : Hilton Washington DC North/Gaithersburg, The Ballrooms, 620 Perry Pkwy., Gaithersburg, MD. *Contact Person* : Teresa Watkins, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane,rm. 1093) Rockville, MD 20857, 301-827-7001, FAX: 301-827-6776, e-mail: *teresa.watkins@fda.hhs.gov* , or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512545. Please call the Information Line for up-to-date information on this meeting. *Agenda* : The committee will discuss the efficacy supplement to new drug application
(NDA)21-077 for the approved product Advair Diskus 500/50 (fluticasone propionate/salmeterol inhalation powder) by GlaxoSmithKline, for the proposed indication of increased survival and reduced exacerbations in patients with chronic obstructive pulmonary disease (COPD). FDA intends to make background material available to the public no later than 1 business day before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at *http://www.fda.gov/ohrms/dockets/ac/acmenu.htm* , click on the year 2007 and scroll down to the appropriate advisory committee link. *Procedure* : Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before April 11, 2007. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before April 3, 2007. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by April 4, 2007. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Teresa Watkins at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: March 14, 2007. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E7-5194 Filed 3-21-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed Meeting The National Cancer Advisory Board's Breast Cancer Prevention Trail P-4 Working Group will meet to discuss the P-4 trial which is designed to perform a 10-year study in risk-eligible, postmenopausal women to determine whether letrozole is more effective than raloxifene in reducing the incidence of invasive breast cancer in this otherwise healthy population. The meeting will be closed to the public. The thoughts and input from this meeting will be summarized in a report that will be presented to the National Cancer Advisory Board in open session at an upcoming meeting. *Name of Work Group:* National Cancer Advisory Board, Breast Cancer Prevention Trial P-4 Working Group. *Closed:* March 23, 2007, 8:30 a.m. to 4:30 p.m. *Agenda:* The purpose of the Work Group will be to ensure that funds are invested optimally to achieve outcomes that utilize the best of clinical and molecular sciences to answer key scientific questions, produce extremely valuable data sets for the community, and, in this instance, provide maximal benefit to breast cancer patients. *Place:* Hyatt Regency Building, One Metro Center, Bethesda, MD 20814. *Contact Person:* Dr. Paulette S. Gray, Executive Secretary, National Cancer Advisory Board, National Cancer Institute, National Institutes of Health, 6116 Executive Boulevard, 8th Floor, Room 8001, Bethesda, MD 20892-8327,
(301)496-5147. SUPPLEMENTARY INFORMATION: Background Over the past several years the National Cancer Institute has performed a series of important prevention clinical trials to study the effects) of tamoxifen, raloxifene (Selective Estrogen Receptor Modulators—SERMS) and, subsequently, aromatase inhibitors such as letrozole on reducing the incidence of invasive breast cancer in defined populations of postmenopausal women. As follow-on to this series of breast cancer prevention trials, a new trial in the sequence, the P-4 trial, has been proposed and peer-reviewed. The P-4 trial is designed to perform a 10-year study in risk-eligible, postmenopausal women to determine whether letrozole is more effective than raloxifene in reducing the incidence of invasive breast cancer in this otherwise healthy population. The trial will accrue 12,800 patients over 4 years. The primary endpoint for this trial will be the first occurrence of invasive breast cancer. Secondary endpoints will include DCIS; LCIS; ischemic heart disease; fracture of the wrist, hip, and spine; DVTs; PEs; TIAs and stroke; death; other invasive cancers; and quality of life. P-4 trial is a significant financial commitment on the part of the National Cancer Institute and of the cancer research community. Additionally, the outcome of this trail will require more than 10 years of study. Given the magnitude of this investment, the rapid acceleration of progress in molecular genetics and molecular biology, and the disparate range of views on the trial, the National Cancer Advisory Board is convening a group of experts to provide feedback to the National Cancer Advisory Board. Any interested person may file written comments with the work group by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS) Dated: March 16, 2007. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 07-1408 Filed 3-21-07; 8:45 am]
Connectionstraces to 30
11 references not yet in our index
  • 34 CFR 79
  • 34 CFR 86
  • 5 CFR 1320.16
  • 12 CFR 225
  • Pub. L. 92-463
  • 29 CFR 1910.1003-1910
  • 44 USC 3501-3520
  • 5 CFR 1320.3(c)
  • 21 CFR 314
  • 21 CFR 600
  • 21 CFR 14
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