An application has been submitted to the Foreign-Trade Zones (FTZ) Board (the Board) by the Koochiching Economic Development Authority, to establish a general-purpose foreign-trade zone at sites in Koochiching County, Minnesota, within the International Falls Customs port of entry. The FTZ application was submitted pursuant to the provisions of the FTZ Act, as amended (19 U.S.C. 81a-81u), and the regulations of the Board (15 CFR part 400). It was formally filed on April 30, 2003. The applicant is authorized to make the proposal under Minnesota Statutes, Chapter 469, as amended by Laws of Minnesota 1989.

The proposed zone would consist of three sites covering 718 acres in Koochiching County, Minnesota: Site 1 (1 acre)—International Falls Airport site, southwest corner of U.S. Highway 53 and Van Lynn Road, Koochiching County; Site 2 (707 acres)—KEDA Business Park, intersection of the D.W. & P. rail line and Minnesota Highway 11, City of Ranier (Koochiching County); and, Site 3 (10 acres)—International Falls Business Park, southeast corner of U.S. Highway 53 and 22nd Street, Koochiching County. All three sites are publicly owned.

The application indicates a need for zone services in Koochiching County. Several firms have indicated an interest in using zone procedures for warehousing/distribution activities. Specific manufacturing approvals are not being sought at this time. Requests would be made to the Board on a case-by-case basis.

In accordance with the Board's regulations, a member of the FTZ Staff has been designated examiner to investigate the application and report to the Board.

As part of the investigation, the Commerce examiner will hold a public hearing on June 9, 2003, at 7 p.m., International Falls Holiday Inn, 1500 Highway 71, International Falls, Minnesota 56649.

Public comment on the application is invited from interested parties. Submissions (original and 3 copies) shall be addressed to the Board's Executive Secretary at one of the following addresses:

1. Submissions via Express/Package Delivery Services: Foreign-Trade Zones Board, U.S. Department of Commerce, Franklin Court Building-Suite 4100W, 1099—14th Street NW., Washington, DC 20005; or

2. Submissions via the U.S. Postal Service: Foreign-Trade Zones Board, U.S. Department of Commerce, FCB—Suite 4100W, 1401 Constitution Avenue NW., Washington, DC 20230.

The closing period for their receipt is July 7, 2003. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period (to July 21, 2003).

A copy of the application and accompanying exhibits will be available for public inspection at the Office of the Foreign-Trade Zones Board's Executive Secretary at the first address listed above, and at the Office of the Koochiching Economic Development Authority, 405—3rd Street, International Falls, Minnesota 56649.

On March 28, 2003, the Department received a timely request from Shanghai Ocean Flavor, in accordance with section 751(a)(2)(B) of the Act and 19 CFR 351.214(c), for a new shipper review of this antidumping duty order on freshwater crawfish tail meat from the People's Republic of China (“PRC”), which has a September anniversary date and a March semiannual anniversary date.

As required by 19 CFR 351.214(b)(2)(ii) and (iii)(A), Shanghai Ocean Flavor, an exporter of crawfish tail meat, has certified that it did not export freshwater crawfish tail meat to the United States during the period of investigation (“POI”), and that it has never been affiliated with any exporter or producer which exported freshwater crawfish tail meat to the United States during the POI. In addition, the producer, Jiangxi Quanfu, certified that it did not export freshwater crawfish tail meat to the United States and that it has never been affiliated with any exporter or producer who exported the subject merchandise to the United States during the POI. Shanghai Ocean Flavor has further certified, pursuant to the requirements of CFR 19 351.214(b)(2)(iii) (B), that its export activities are not controlled by the central government of the PRC.

Pursuant to 19 CFR 351.214(b)(2)(iv), Shanghai Ocean Flavor submitted documentation establishing the date on which it first shipped the subject merchandise to the United States, the date of entry of the first shipment, the volume of that shipment, and the date of the first sale to an unaffiliated customer in the United States. Shanghai Ocean Flavor provided the same documentation for its one subsequent shipment.

After reviewing the submissions with respect to the new shipper review request filed on behalf of Shanghai Ocean Flavor and Jiangxi Quanfu, the Department has found that the requirements set forth in 19 CFR 351.214(b) for the initiation of a new shipper review have been met.

In accordance with section 751(a)(2)(B)(ii) of the Act and 19 CFR 351.214(d)(1), we are initiating a new shipper review of the antidumping duty order on freshwater crawfish tail meat from the PRC. Based on our analysis of the information and documentation provided with the new shipper review request, as well as our analysis of proprietary import data from the U.S. Bureau of Customs and Border Protection (“BCBP”), we intend to carefully examine the bona fides of Shanghai Ocean Flavor's U.S. sales during the course of this new shipper review. We intend to issue the preliminary results of the review no later than180 days after the date on which the review is initiated.

In accordance with 19 CFR 351.214(g)(1)(i)(B), the period of review (“POR”) for a new shipper review, initiated in the month immediately following the semiannual anniversary month, will be the six-month period immediately preceding the semiannual anniversary month. Therefore, the POR for this new shipper review is:

We will instruct the BCBP to allow, at the option of the importer, the posting, until the completion of the review, of a bond in lieu of a cash deposit for each entry of the merchandise exported by Shanghai Ocean Flavor. This action is in accordance with 19 CFR 351.214(e). We will apply the bonding option under 19 CFR 351.107(b)(1)(i) only to entries of subject merchandise exported by Shanghai Ocean Flavor for which Jiangxi Quanfu, the producer under review, is the supplier.

The interested parties that need access to proprietary information in this new shipper review should submit applications for disclosure under administrative protective order in accordance with 19 CFR 351.305 and 19 CFR 351.306.

This initiation and notice are in accordance with sections 751(a)(2)(B) of the Act (19 U.S.C.1675(a)) and 19 CFR 351.214(d).

Pursuant to section 6(c) of the Educational, Scientific and Cultural Materials Importation Act of 1966 (Pub. L. 89-651; 80 Stat. 897; 15 CFR part 301), we invite comments on the question of whether instruments of equivalent scientific value, for the purposes for which the instruments shown below are intended to be used, are being manufactured in the United States.

Comments must comply with 15 CFR 301.5(a)(3) and (4) of the regulations and be filed within 20 days with the Statutory Import Programs Staff, U.S. Department of Commerce, Washington, DC 20230. Applications may be examined between 8:30 a.m. and 5 p.m. in Suite 4100W, U.S. Department of Commerce, Franklin Court Building, 1099 14th Street, NW, Washington, DC.

Docket Number: 03-017. Applicant: University of California, San Diego, Moores UCSD Cancer Center, 9500 Gilman Drive, MC 0658, La Jolla, CA 92093-0658. Instrument: Laser Capture Microdissection System. Manufacturer: Molecular Machines & Industries AG, Switzerland. Intended Use: The instrument is intended to be used for precise sampling of cancer cells intimately mixed with other tissue elements such as fibroblasts, smooth muscle cells, etc. for precise analysis of gene expression patterns in cancer cells relative to their non-neoplastic counterparts. Additionally, the instrument will be used to conduct highly selective sampling of endothelial cells, fibroblasts, epithelial cells and lymphocytes in the vicinity of proliferating tumor cells to investigate the molecular communications between different neoplastic and non-neoplastic cell lineages in the tumor. Application accepted by Commissioner of Customs: April 3, 2003.

Docket Number: 03-018. Applicant: University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center, 102 Mason Farm Road, Room 11-119, Chapel Hill, NC 27599-7295. Instrument: Electron Microscope, Model Tecnai G 2 12 TWIN. Manufacturer: FEI Company, The Netherlands. Intended Use: The instrument is intended to be used to examine DNA, DNA with proteins bound to it, virus particles and sub-cellular particles. Sample examination will consist of determining the location of protein molecules along the DNA, whether the DNA molecule is folded or compacted when the proteins are bound, and whether the DNA has any unique shape. Virus properties to be examined will include their shape, size, presence of protruding spikes or appendages, and whether they have loose membranes surrounding them. Application accepted by Commissioner of Customs: April 9, 2003.

Docket Number: 03-019. Applicant: University of California-Berkeley, School of Optometry, 360 Minor Hall, Berkeley, CA 94720-2020. Instrument: Fiber Optical Coherence Tomography Apparatus. Manufacturer: Institute of Applied Physics RAS, Russia. Intended Use: The instrument is intended to be used in the following areas of research:

(1) Viral mediated gene therapy for retinal diseases.

(2) Significance of corneal cell invasion by bacteria.

(3) Homeostatic abilities of the retinal pigment epithelium.

(4) Is retinal processing the key to emmetropization?

(5) Functional dissection of signaling pathways in the lens.

(6) Cataractogensis, connexin mutants and gentice modifier(s). Application accepted by Commissioner of Customs: April 9, 2003.

Docket Number: 03-020. Applicant: Wayne State University, Chemistry Department, Central Instrumental Facility, 123 Chemistry Building, Detroit, MI 48202. Instrument: Electron Microscope, Model JEM-2010 FasTEM. Manufacturer: JEOL Ltd., Japan. Intended Use: The instrument is intended to be used to probe agglomeration of particles and the nature of ligand coat. A variety of synthetic pathways will be undertaken to best optimize the formation of these materials. Selected area electron diffraction will augment these studies to identify the crystalline phase, and energy dispersive X-ray analysis will be used to gain information about the elements that are present in the nanocrystal samples. Application accepted by Commissioner of Customs: April 16, 2003.

Take notice that on April 23, 2003, El Paso Natural Gas Company (EPNG) tendered for filing, to be part of its FERC Gas Tariff, Second Revised Volume No. 1-A, Nineteenth Revised Sheet No. 1, to become effective May 23, 2003, and a firm transportation agreement.

EPNG states that the transportation agreement is being submitted for Commission review under the Commission's material deviation policies and has been listed on the tendered tariff sheet as a non-conforming agreement.

Any person desiring to be heard or to protest said filing should file a motion to intervene or a protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with sections 385.314 or 385.211 of the Commission's rules and regulations. All such motions or protests must be filed on or before the comment date. 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 proceedings. Any person wishing to become a party must file a motion to intervene. This filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at http://www.ferc.gov using the “FERRIS” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, please contact FERC Online Support at FERCOnlineSupport@ferc.gov or toll-free at (866) 208-3676, or TTY, contact (202) 502-8659. The Commission strongly encourages electronic filings. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site under the “e-Filing” link.

Comment Date: May 7, 2003.

Take notice that on April 3, 2003, Gulf South Pipeline Company, LP (Gulf South) filed additional information to comply with the Commission's March 14, 2003, Letter Order approving Gulf South's 2002 Cash-in/Cash-out Report, subject to Gulf South providing additional information. (102 FERC § 61,293 (2003)) Gulf South states that this information addresses concerns raised with respect to Gulf South's cumulative ending volume and cash deficiencies reflected in the report.

Gulf South states that copies of this filing have been served upon each person designated on the official service list compiled by the Federal Energy Regulatory Commission in this proceeding.

Any person desiring to protest said filing should file a protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with section 385.211 of the Commission's Rules and Regulations. All such protests must be filed on or before May 7, 2003. 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 proceedings. This filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at http://www.ferc.gov using the “FERRIS” link. Enter the docket number excluding the last three digits in the docket number field to access the document. Comments, protests and interventions may be filed electronically via the Internet in lieu of paper. For assistance, please contact FERC Online Support at FERCOnlineSupport@ferc.gov or toll-free at (866) 208-3676, or TTY, contact (202) 502-8659. The Commission strongly encourages electronic filings. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site under the “e-Filing” link.

Take notice that on April 24, 2003, Portland Natural Gas Transmission System (PNGTS) tendered for filing, as part of its FERC Gas Tariff, Original Volume No. 1, Fifth Revised Sheet No. 100, effective November 12, 2002.

PNGTS states that the purpose of its filing is to comply with the Commission's order issued on April 14, 2003, in Docket No. RP02-13-005, which approved PNGTS's November 12, 2002 compliance filing, with one modification. PNGTS indicates that this one modification required PNGTS to revise the statement of the maximum recourse rate for PNGTS's seasonal FT service. Accordingly, PNGTS states that it is submitting a modified Tariff Sheet No. 100 as required.

PNGTS states that copies of this filing are being served on all jurisdictional customers, applicable state commissions, and participants in Docket No. RP02-13-000.

Any person desiring to protest said filing should file a protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with section 385.211 of the Commission's Rules and Regulations. All such protests must be filed in accordance with section 154.210 of the Commission's Regulations. 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 proceedings. This filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at http://www.ferc.gov using the “FERRIS” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, please contact FERC Online Support at FERCOnlineSupport@ferc.gov or toll-free at (866) 208-3676, or TTY, contact (202) 502-8659. The Commission strongly encourages electronic filings. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site under the “e-Filing” link.

Protest Date: May 6, 2003.

Take notice that on April 25, 2003, Southern Star Central Gas Pipeline, Inc. (Southern Star Central) tendered for filing, as part of its FERC Gas Tariff, Original Volume No. 1, the following tariff sheets to become effective May 1, 2003:

Southern Star states that the purpose of this filing is to restate Southern Star's FERC Gas Tariff, Original Volume No. 1 to reflect its name change to Southern Star Central Gas Pipeline, Inc. rather than Williams Gas Pipelines Central, Inc. as currently on file with the Commission. The instant filing reflects the change to Southern Star, the repagination of tariff sheets and minor modifications to the text of various tariff sheets to reflect the repagination.

Southern Star states that the instant filing makes no changes to the Rates, Rate Schedules, General Terms and Conditions or Form of Service Agreements. Southern Star states that it has requested withdrawal of its March 31, 2003, filing in Docket No. RP03-324, et al. , relating to a name change with a LLC designation.

Southern Star states that copies of the transmittal letter and appendices (excluding Appendices C and D) are being mailed to Southern Star's jurisdictional customers and interested state commissions.

Any person desiring to be heard or to protest said filing should file a motion to intervene or a protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with sections 385.314 or 385.211 of the Commission's rules and regulations. All such motions or protests must be filed in accordance with section 154.210 of the Commission's regulations. 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 proceedings. Any person wishing to become a party must file a motion to intervene. This filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at http://www.ferc.gov using the “FERRIS” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, please contact FERC Online Support at FERCOnlineSupport@ferc.gov or toll-free at (866) 208-3676, or TTY, contact (202) 502-8659. The Commission strongly encourages electronic filings. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site under the “e-Filing” link.

Comment Date: May 7, 2003.

Take notice that on April 1, 2003, Viking Gas Transmission Company (Viking) tendered for filing as part of its FERC Gas Tariff, First Revised Volume No. 1, the following tariff sheets to become effective June 1, 2002:

Viking indicates that these tariff sheets describe two negotiated rate contracts, Contract Numbers 8007 and 8013. Viking states that it is also filing copies of Contract Numbers 8007 and 8013 for Commission review.

Viking states that copies of this filing have been served on Viking's jurisdictional customers and to affected state regulatory commissions.

Any person desiring to be heard or to protest said filing should file a motion to intervene or a protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with sections 385.314 or 385.211 of the Commission's rules and regulations. All such motions or protests must be filed on or before the comment date below. 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 proceedings. Any person wishing to become a party must file a motion to intervene. This filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at http://www.ferc.gov using the “FERRIS” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, please contact FERC Online Support at FERCOnlineSupport@ferc.gov or toll-free at (866) 208-3676, or TTY, contact (202) 502-8659. The Commission strongly encourages electronic filings. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site under the “e-Filing” link.

Comment Date: May 7, 2003.

Take notice that on April 25, 2003, Williston Basin Interstate Pipeline Company (Williston Basin) tendered for filing, as part of its FERC Gas Tariff, Second Revised Volume No. 1 and Original Volume No. 2, the compliance tariff sheets included in Appendix A to the filing, to become effective on September 1, 2003.

Williston Basin states that the filing is being made pursuant to the Commission's “Order Conditionally Accepting and Suspending Tariff Sheets Subject to Conditions,” issued March 26, 2003.

Williston Basin states that as directed by the Commission's March 26 Order, Williston Basin has removed the proposed flex adjustment provision, changed the effective date for implementation of the revised tariff provisions, revised fuel reimbursement percentages and electric power reimbursement rates and corrected the pagination of the respective tariff sheets.

Any person desiring to protest said filing should file a protest with the Federal Energy Regulatory Commission, 888 First Street,NE., Washington, DC 20426, in accordance with section 385.211 of the Commission's Rules and Regulations. All such protests must be filed in accordance with section 154.210 of the Commission's Regulations. 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 proceedings. This filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at http://www.ferc.gov using the “FERRIS” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, please contact FERC Online Support at FERCOnlineSupport@ferc.gov or toll-free at (866) 208-3676, or TTY, contact (202) 502-8659. The Commission strongly encourages electronic filings. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site under the “e-Filing” link.

Protest Date: May 7, 2003.

The following filings have been made with the Commission. The filings are listed in ascending order within each docket classification.

Take notice that on April 25, 2003, Flying Cloud Power Partners, LLC, a Delaware limited liability company (Flying Cloud), filed a Change In Status with the Federal Energy Regulatory Commission. Flying Cloud states that the filing reflects a change in ownership of Flying Cloud from Clipper Windpower Development Company, Inc., a Delaware corporation, to Heartland Wind LLC, an Oregon limited liability company, effective March 31, 2003.

Comment Date: May 16, 2003.

Take notice that on April 7, 2003, Southern Company Services, Inc., (SCS) acting on behalf of Georgia Power Company (GPC), filed with the Federal Energy Regulatory Commission (Commission) a compliance filing in response to the deficiency letter dated March 6, 2003, by the Director, Division of Tariffs and Market Development-South.

Comment Date: May 9, 2003.

Take notice that on April 24, 2003, Southern Company Services, Inc. (SCS), acting on behalf of Alabama Power Company, Georgia Power Company, Gulf Power Company, Mississippi Power Company, and Savannah Electric and Power Company (collectively Southern Companies), resubmitted three rollover transmission service agreements under the Open Access Transmission Tariff of Southern Companies (FERC Electric Tariff, Fourth Revised Volume No. 5) (Tariff). Specifically, Southern Companies states that these agreements are for firm point-to-point rollover transmission service with Calpine Energy Services, LP (First Revised Service Agreement No. 441), Carolina Power & Light Company (First Revised Service Agreement No. 444), and Duke Energy Corporation (First Revised Service Agreement No. 446) and are being refiled to comply with the Commission's order in this proceeding dated March 26, 2003.

Comment Date: May 15, 2003.

Take notice that on April 25, 2003, PECO Energy Company (PECO) submitted for filing a corrected First Revised Sheet No. 42 to the Construction Agreement between PECO and Old Dominion Electric Cooperative (Old Dominion) designated as Service Agreement No. 683 under the PJM Open Access Transmission Tariff. PECO states that it submitted this filing to correct an error in the First Revised Sheet No. 42 that was previously filed with the Commission on April 4, 2003, under Docket ER03-706-000.

PECO states that copies of this filing were served on Old Dominion and PJM Interconnection, L.L.C.

Comment Date: May 16, 2003.

Take notice that on April 24, 2003, Solaro Energy Power Marketing Corporation (Solaro Energy) submitted an amended petition for acceptance of Solaro Energy Rate Schedule FERC No. 1; the granting of certain blanket approvals, including the authority to sell electricity at market-based rates; and the waiver of certain Commission regulations which was originally filed on April 16, 2003.

Solaro Energy states that the amended petition clarifies its April 16, 2003 filing by indicating that Solaro Energy: (1) Intends to engage in wholesale electric power and energy purchases and sales as a marketer; (2) is not in the business of generating or transmitting electric power; and (3) is a wholly-owned subsidiary of Solaro Energy Marketing Corporation.

Comment Date: May 15, 2003.

Take notice that on April 24, 2003, Accent Energy New Jersey LLC (Accent) petitioned the Federal Energy Regulatory Commission for acceptance of Accent Rate Schedule FERC No. 1; the granting of certain blanket approvals, including the authority to sell electricity at market-based rates; and the waiver of certain Commission regulations.

Accent states that it intends to engage in wholesale electric power and energy purchases and sales as a marketer. Accent indicates that it is not in the business of generating or transmitting electric power. Accent states that it sells electricity to customers in various deregulated states.

Comment Date: May 15, 2003.

Take notice that on April 24, 2003, Tampa Electric Company (TEC) tendered for filing a Notice of Termination of the Interconnection and Operating Agreement (IOA) between Tampa Electric Company and Cargill Fertilizer, Inc., (Cargill) Substitute Service Agreement No. 77. TEC states that termination of the IOA has been mutually agreed to by TEC and Cargill. TEC requests that the termination be made effective March 25, 2003, as mutually agreed by the parties.

Comment Date: May 15, 2003.

Take notice that on April 24, 2003, New England Power Company (NEP) submitted for filing First Revised Service Agreement No. 179 between NEP and Pascoag Utility District under NEP's open access transmission tariff, New England Power Company, FERC Electric Tariff, Second Revised Volume No. 9. NEP states that the parties have modified the Service Agreement to include provisions for metering associated with a new substation that will connect to the lines of NEP's affiliate the Narragansett Electric Company. NEP indicates that this substation contains a new switch gear, the design of which includes equipment to measure deliveries over NECO lines.

Comment Date: May 15, 2003.

Take notice that on April 25, 2003, Eagle Energy Partners, Inc., petitioned the Commission for acceptance of its Rate Schedule FERC No. 1, the granting of certain blanket approvals, including the authority to sell electricity at market-based rates, and the waiver of certain of the Commission's Regulations.

Comment Date: May 16, 2003.

Take notice that on April 25, 2003, FortisOntario Inc., tendered for filing a Notice of Succession pursuant to section 35.16 of the Commission's Regulations. As a result of the amalgamation, approved by letter order dated January 31, 2003, in Docket No. EC03-41-000, FortisOntario states it is succeeding to the tariffs and related service agreements of FortisUS Energy Corporation, effective April 1, 2003.

Comment Date: May 16, 2003.

Any person desiring to intervene or to protest this filing should file with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, 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 motion to intervene. All such motions or protests should be filed on or before the comment date, and, to the extent applicable, must be served on the applicant and on any other person designated on the official service list. This filing is available for review at the Commission or may be viewed on the Commission's Web site at http://www.ferc.gov , using the “FERRIS” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact FERC Online Support at FERCOnlineSupport@ferc.gov or toll-free at (866) 208-3676, or for TTY, contact (202) 502-8659. Protests and interventions may be filed electronically via the Internet in lieu of paper; see 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site under the “e-Filing” link. The Commission strongly encourages electronic filings.

a. Type of Filing: Notice of Intent to File an Application for a New License.

b. Project No.: 2206.

c. Date Filed: April 23, 2003.

d. Submitted By: Carolina Power and Light Company—current licensee.

e. Name of Project: Yadkin-Pee Dee River Hydroelectric Project.

f. Location: On the Yadkin-Pee Dee River in Montgomery, Stanly, Anson, and Richmond Counties, North Carolina. The project does not occupy federal lands.

g. Filed Pursuant to: Section 15 of the Federal Power Act.

h. Licensee Contact: Barry Arney, Progress Energy Carolinas, Inc., Blewett Falls Hydro Plant, SR 1748 Rt. 1 Box 148, Lilesville, NC 28091, (704) 848-4320, ext. 1220.

i. FERC Contact: Ron McKitrick, ronald.mckitrick@ferc.gov, (770) 452-3778.

j. Effective date of current license: May 1, 1958.

k. Expiration date of current license: April 30, 2008.

l. Description of the Project: The project consists of the following two developments:

The Tillery Development consists of the following existing facilities: (1) A 1,200-foot-long earth embankment; (2) a 1,500-foot-long concrete dam with a gated spillway; (3) the 5,260-acre Lake Tillery reservoir with a normal operating level of 278.17 feet msl; (4) a powerhouse integral to the dam containing four generating units with a total installed capacity of 84 MW; and (5) other appurtenances.

The Blewett Development consists of the following existing facilities: (1) One 870-foot-long, and one 850-foot-long earth embankments; (2) a 2,090-foot-long concrete dam with a spillway topped with flashboards; (3) the 2,560-acre Blewett Falls Lake reservoir with a normal operating level of 178.08 feet msl; (4) a powerhouse containing six generating units with a total installed capacity of 24.6 MW; and (5) other appurtenances.

m. Each application for a new license and any competing license applications must be filed with the Commission at least 24 months prior to the expiration of the existing license. All applications for license for this project must be filed by April 30, 2006.

n. A copy of this filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's website at http://www.ferc.gov using the “FERRIS” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact FERC Online Support at FERCOnlineSupport@ferc.gov or toll-free at 1-866-208-3676, or TTY (202) 502-8659. A copy is also available for inspection and reproduction at the address in item h above.

Register online at http://www.ferc.gov/esubscribenow.htm to be notified via email of new filings and issuances related to this or other pending projects. For assistance, contact FERC Online Support as shown in the paragraph above.

Take notice that the following settlement agreement has been filed with the Commission and is available for public inspection.

a. Type of Application: Settlement Agreement.

b. Project No.: 184-065.

c. Date filed: April 29, 2003.

d. Applicant: El Dorado Irrigation District.

e. Name of Project: El Dorado Project.

f. Location: Located on the South Fork of the American River and its tributaries in the counties of El Dorado, Alpine, and Amador, California, partially within the boundaries of the Eldorado National Forest. The project also diverts about 1,900 acre-feet of water from lower Echo Lake in the upper Truckee River Basin.

g. Filed Pursuant to: Rule 602 of the Commission's Rules of Practice and Procedure, 18 CFR 385.602.

h. Applicant Contact: Dr. Scott E. Shewbridge, El Dorado Irrigation District, 2890 Mosquito Road, Placerville, CA 95667-4700. Telephone (530) 622-4513.

i. FERC Contact: Any questions concerning this notice should be addressed to Susan O'Brien, e-mail address susan.obrien@ferc.gov, or telephone (202) 502-8849.

j. Deadline for filing comments: The deadline for filing comments on the Settlement Agreement and the DEIS is May 19, 2003. Reply comments due May 29, 2003.

All documents (original and eight copies) should be filed with: Magalie R. Salas, Secretary, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426.

The Commission's Rules of Practice require all intervenors filing documents with the Commission to serve a copy of that document on each person on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.

Comments may be filed electronically via the Internet in lieu of paper. The Commission strongly encourages electronic filings. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's web site ( http://www.ferc.gov ) under the “e-Filing” link.

k. El Dorado Irrigation District filed the Settlement Agreement on behalf of itself and the U.S. Department of Agriculture Forest Service, U.S. Department of the Interior-National Park Service, California Department of Fish and Game, the County of Alpine, the County of Amador, El Dorado County Water Agency, El Dorado Citizens for Water, Friends of the River, Trout Unlimited, Sierra Club, American Whitewater, Citizens for Water, AKT Development, Chris Shutes, Richard D. Wentzel, Alice Q. Howard, and Paul J. Creger. The purpose of the Settlement Agreement is to resolve among the signatories all issues associated with issuance of a new license for the project regarding project operations, minimum streamflows, reservoir elevations, environmental restoration and enhancement measures, and recreational resource enhancements. The term of license was not resolved by the Settlement Agreement.

l. A copy of the settlement agreement is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at http://www.ferc.gov using the “FERRIS” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact FERC Online Support at FERCOnlineSupport@ferc.gov or toll-free at 1-866-208-3676, or for TTY, (202) 502-8659. A copy is also available for inspection and reproduction at the address in item h above.

Register online at http://www.ferc.gov/esubscribenow.htm to be notified via e-mail of new filings and issuances related to this or other pending projects. For assistance, contact FERC Online Support.

m. Procedural schedule: The application will be processed according to the following Hydro Licensing Schedule. Revisions to the schedule will be made as appropriate.

Comments on DEIS and Settlement Agreement: May 19, 2003.

Notice of the availability of the FEIS: July 2003.

Take notice that the following documents are incorporated into the record of the proceeding for Project No. 2069-007.

(1) Unequivocal statement of intent to file an application for new license by Arizona Public Service Company, FERC Project No. 2069, volumes 1-7, Arizona Public Service Company (APS), December 1989, filed on December 27, 1989.

(2) Application for new license for major project—existing dam Childs & Irving Hydroelectric Project, FERC Project No. 2069, volumes I-IV, Arizona Public Service Company, December 1992 (volumes I-III) and July 1993 (vol. IV), filed on December 18, 1992, and July 9, 1993, respectively.

(3) New fish habitat curves for Fossil Creek, re: relicensing of Childs-Irving Project (P-2069), filed on January 21, 1994.

(4) Scoping document 2, Childs Irving Hydroelectric Project environmental assessment, FERC Project No. 2069-003, Office of Hydropower Licensing, FERC, and Coconino National Forest, U.S. Forest Service (USFS), issued on August 17, 1994.

(5) Coconino National Forest land and resource management plan, dated August 1987, filed by the USFS on October 24, 1994.

(6) Velocity-discharge data for Fossil Creek, filed by CH2M Hill on June 29, 1995.

(7) Draft environmental assessment for hydropower license, Childs Irving Project, FERC Project No. 2069-003, Arizona. Division of Licensing and Compliance, Office of Hydropower Licensing, FERC and Beaver Creek Ranger District, Coconino National Forest, U.S. Department of Agriculture, issued August 14, 1997.

(8) Comments of John Malusa on draft environmental assessment, filed on September 15, 1997.

(9) Comments of the USFS on draft environmental assessment, filed by the Southwestern Region of USFS, Albuquerque, New Mexico, filed on September 26, 1997.

(10) Natural geochemical evolution of a travertine depositing spring: Fossil Springs, Arizona, December 1997, John Malusa, Northern Arizona University, filed by the USFS on November 12, 1997.

(11) Childs & Irving biological report, September 1998, EnviroNet, Inc., Phoenix, Arizona, filed by APS on September 11, 1998.

(12) Fossil Creek hydrology & travertine geomorphology, June 25, 1998, W.L. Bouchard & Associates, Inc., Phoenix, Arizona, filed by APS on September 11, 1998.

(13) Peregrine falcon potential nesting habitat APS Childs & Irving Hydroelectric Plants, Fossil Creek, Arizona, August 1998, EnviroNet, Inc., Phoenix, Arizona, filed by APS on September 11, 1998.

(14) Childs & Irving biological report—razorback sucker, October 1998, EnviroNet, Inc., Phoenix, Arizona, filed by APS on November 2, 1998.

(15) Review of Childs and Irving biological report—razorback sucker, October 1998, February 1999, Jerome A. Stefferud, filed by the USFS on February 5, 1999.

(16) APS and Tonto National Forest submittals of “Fossil Creek Flood Peaks, Current, Natural and Degraded Watershed Conditions,” by Grant Loomis, dated October 1994, filed on July 23, 1999, and September 24, 1999, respectively.

(17) Additional comments on travertine deposition estimates—Fossil Creek, Arizona, September 1999, Steven T. Overby and Daniel Neary, Rocky Mountain Research Station, USFS, Flagstaff, Arizona, filed by USFS on September 13, 1999.

(18) Tonto National Forest land and resource management plan, dated October 1985, filed by the USFS on September 24, 1999.

(19) Submission of additional information from Professor W.L. Minckley, Department of Biology, Arizona State University, characterizing the existing native fish assemblage and the unprecedented opportunity to restore full flows for native fish restoration of Fossil Creek; Childs-Irving Hydroelectric Project, FERC Project No. 2069-003, Arizona, filed by the Southwest Regional Office of American Rivers, Phoenix, Arizona, on November 9, 1999.

(20) Submission of additional information from John Malusa, hydrologist, identifying inaccuracies of the APS report titled “Fossil Creek Hydrology & Travertine Geomorphology,” and further characterizing the travertine deposition and erosion rates along Fossil Creek, Childs Irving Hydroelectric Project, Southwest Regional Office, American Rivers, Phoenix, Arizona, filed by American Rivers on December 21, 1999.

(21) USFS update on its involvement with the settlement discussions, filed on June 12, 2000.

(22) USFS comments on settlement agreement, filed on September 27, 2000.

(23) U.S. Fish and Wildlife Service comments on settlement agreement, filed on October 23, 2000.

(24) USFS follow-up comments on settlement agreement, including minutes of meeting of fisheries biologists re: Fossil Creek (Childs/Irving), dated May 24, 2000; and a preliminary analysis of effects of Fossil Springs dam removal alternatives on riparian habitat and special status species, dated October 23, 2000, by C. Overby and J. Agyagos, filed on October 24, 2000.

(25) Summary of January 10, 2001, technical conference, issued on February 8, 2001.

(26) Declaratory Order, issued on December 20, 2001.

For further information, please contact Dianne Rodman at (202) 502-6077.

This constitutes notice, in accordance with 18 CFR 385.2201(h), of the receipt of exempt and prohibited off-the-record communications.

Order No. 607 (64 FR 51222, September 22, 1999) requires Commission decisional employees, who make or receive an exempt or a prohibited off-the-record communication relevant to the merits of a contested on-the-record proceeding, to deliver a copy of the communication, if written, or a summary of the substance of any oral communication, to the Secretary.

Prohibited communications will be included in a public, non-decisional file associated with, but not part of, the decisional record of the proceeding. Unless the Commission determines that the prohibited communication and any responses thereto should become part of the decisional record, the prohibited off-the-record communication will not be considered by the Commission in reaching its decision. Parties to a proceeding may seek the opportunity to respond to any facts or contentions made in a prohibited off-the-record communication, and may request that the Commission place the prohibited communication and responses thereto in the decisional record. The Commission will grant such requests only when it determines that fairness so requires. Any person identified below as having made a prohibited off-the-record communication should serve the document on all parties listed on the official service list for the applicable proceeding in accordance with Rule 2010, 18 CFR 385.2010.

Exempt off-the-record communications will be included in the decisional record of the proceeding, unless the communication was with a cooperating agency as described by 40 CFR 1501.6, made under 18 CFR 385.2201(e)(1)(v). The following is a list of prohibited and exempt communications recently received in the Office of the Secretary. The communications listed are grouped by docket numbers. These filings are available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at http://www.ferc.gov using the “FERRIS” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For Assistance, please contact FERC Online Support at FERCOnlineSupport@ferc.gov or toll-free at (866) 208-3676, or for TTY, contact (202) 502-8659.

Notice is hereby given that the following have been issued a Certificate of Financial Responsibility to Meet Liability Incurred for Death or Injury to Passengers or Other Persons on Voyages pursuant to the provisions of section 2, Public Law 89-777 (46 App. U.S.C. 817(d)) and the Federal Maritime Commission's implementing regulations at 46 CFR part 540, as amended:

Notice is hereby given that the following have been issued a Certificate of Financial Responsibility for Indemnification of Passengers for Nonperformance of Transportation pursuant to the provisions of Section 3, Public Law 89-777 (46 App. U.S.C. 817 (e)) and the Federal Maritime Commission's implementing regulations at 46 CFR part 540, as amended:

Application Deadline: June 15, 2003.

This program is authorized under section 301(a) and 317(k)(2) of the Public Health Service Act, (42 U.S.C. section 241(a) and 247(k)(2)), as amended. The Catalog of Federal Domestic Assistance number is 93.283.

The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2003 funds for a cooperative agreement program for Development and Testing of New Medications for Treatment of Emerging Infectious Diseases. This program addresses the “Healthy People 2010” focus area(s) Immunization and Infectious Diseases.

The purpose of the program is to develop and test new anti-infectious agents developed from natural products primarily for use in humans. Of particular, but not exclusive interest are anti-infective agents for parasitic diseases. Projects may include, but are not limited to a range of activities such as identifying promising agents, purifying or creating them, optimizing them for clinical use, and testing them.

Measurable outcomes of the program will be in alignment with the following performance goal for the National Center for Infectious Diseases (NCID): Protect Americans from infectious diseases.

Applications may be submitted by public and private nonprofit organizations and and by governments and their agencies, that is:

Approximately $1,500,000 is available in FY 2003 to fund one award. It is expected that the award will begin on or about September 15, 2003, and will be made for a 12-month budget period within a project period of up to three years. The funding estimate may change.

A continuation award within an approved project period will be made on the basis of satisfactory progress as evidenced by required reports and the availability of funds.

Matching funds are not required for this program.

Applications for new studies are encouraged. Funding preference may be given to the competing continuation application over applications for programs not already receiving support under the existing program. The current awardee has implemented strategies and begun developing and testing for treatment of infectious diseases using natural products. This research requires continued support to become fully developed and to realize the benefits of continued product development.

In conducting activities to achieve the purpose of this program, the recipient will be responsible for the activities listed under 1. Recipient Activities, and CDC will be responsible for the activities listed under 2. CDC Activities.

a. Develop and implement strategies for selection of emerging infectious disease(s) that affect humans, and for acquiring or developing new medications for treatment of those diseases using natural products. This includes studying the pharmacologic and biologic characteristics of natural product structures and analogs and designing molecules using computer methods for known biochemical targets.

b. Use combinatorial methods to optimize anti-infectives resulting from these approaches.

c. Develop strategies and capacity to produce adequate quantities of compound, for example, by using an automated organic synthesizer or other technology.

d. Develop and implement a systematic approach to in vitro testing of drug candidates.

e. Conduct in vivo testing of promising candidates if appropriate.

f. Develop a plan for enhancing commercial interest in promising drugs.

g. Publish and disseminate the research results.

a. Assist in the design and conduct of the research through consultations and meetings between CDC experts and the Recipient.

b. Perform selected in vivo and ex vivo laboratory tests available at CDC for drug activity and efficacy on parasitic protozoan parasites. These assays will be performed on promising compounds that have undergone initial basic in vitro biochemical and computer modeling screens by the Awardee.

c. Provide biological materials from the CDC repository in the form of various parasitic protozoan species with strains of variable geographical origin, genetic background and phenotypic differences and are necessary to analyze the full range of drug efficacy of promising chemotherapeutic compounds to be developed.

d. Assist in the development of assays for evaluating pharmacokinetics of new drugs.

e. Assist in the development of a research protocol for Institutional Review Board (IRB) review by all cooperating institutions participating in the research project. The CDC IRB will review and approve the protocol initially and on at least an annual basis until the research project is completed.

The Program Announcement title and number must appear in the application. Use the information in the Program Requirements, Other Requirements, and Evaluation Criteria sections to develop the application content. Your application will be evaluated on the criteria listed, so it is important to follow them in laying out your program plan. The narrative should be no more than 10 pages, double-spaced, printed on one side, with one-inch margins, and unreduced 12-point font.

The narrative should consist of capacity, objectives and technical approach, background and need, evaluation plan, measures of effectiveness and budget.

Submit the signed original and two copies of PHS 398 (OMB Number 0925-0001). Adhere to the instructions on the Errata Instruction Sheet (posted on the CDC web site) for PHS 398. Forms are available at the following Internet address: http://www.cdc.gov/od/pgo/forminfo.htm. If you do not have access to the Internet, or if you have difficulty accessing the forms on-line, you may contact the CDC Procurement and Grants Office Technical Information Management Section (PGO-TIM) at: 770-488-2700. Application forms can be mailed to you.

The application must be received by 4 p.m. Eastern Time June 15, 2003. Submit the application to: Technical Information Management-PA03056, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146. Applications may not be submitted electronically.

A postcard will be mailed by PGO-TIM, notifying you that CDC has received your application.

Applications shall be considered as meeting the deadline if they are received before 4 p.m. Eastern Time on the deadline date. Any applicant who sends their application by the United States Postal Service or commercial delivery services must ensure that the carrier will be able to guarantee delivery of the application by the closing date and time. If an application is received after closing due to (1) carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time, or (2) significant weather delays or natural disasters, CDC will upon receipt of proper documentation, consider the application as having been received by the deadline.

Any application that does not meet the above criteria will not be eligible for competition, and will be discarded. The applicant will be notified of their failure to meet the submission requirements.

Applicants are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the cooperative agreement. Measures of effectiveness must relate to the performance goals stated in the purpose section of this announcement. Measures must be objective and quantitative and must measure the intended outcome. These measures of effectiveness must be submitted with the application and will be an element of evaluation.

An independent review group appointed by CDC will evaluate each application against the following criteria:

Extent to which applicant describes adequate resources and facilities (both technical and administrative) to use natural products, computer-aided drug design, and development of analogs of known drugs to develop strategies for producing adequate quantities of compound, for example, by using automated organic synthesis or other technologies for conducting the project. Extent to which applicant documents that professional personnel involved in the project are qualified and have past experience and achievements in research related to that proposed as evidenced by curriculum vitae, publications, etc. If applicable, extent to which applicant includes letters of support from participating non-applicant organizations, individuals, etc., and the extent to which such letters clearly indicate the author's commitment to participate as described in the operational plan.

a. Extent to which applicant presents a detailed operational plan for initiating and conducting the project. The plan must clearly and appropriately address all recipient activities for the specific programmatic focus area being addressed. Extent to which applicant clearly identifies specific assigned responsibilities of all key professional personnel. Extent to which the plan clearly describes applicant's technical approach/methods for conducting the proposed studies and extent to which the approach/methods are feasible, appropriate, and adequate to accomplish the objectives. Extent to which applicant describes specific study protocols or plans for the development of study protocols that are appropriate for achieving project objectives. Extent to which applicant clearly describes collaboration with others during various phases of the project. (25 points)

b. Extent to which applicant describes measurable and time-phased objectives of the proposed project which are consistent with the purpose of the focus area being addressed. (10 points)

c. Does the application adequately address the CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research. This includes:

(1) The proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation.

(2) The proposed justification when representation is limited or absent.

(3) A statement as to whether the design of the study is adequate to measure differences when warranted.

(4) A statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with community(ies) and recognition of mutual benefits. (5 points)

Extent to which applicant demonstrates a clear understanding of the background, purpose, and objectives of the focus area being addressed and the relevance of disease(s) to be studied. Extent to which applicant demonstrates that the proposed project addresses the purpose. Extent to which the applicant demonstrates that the proposed program collaborates with and does not duplicate existing rational development efforts.

Extent to which applicant provides a detailed and adequate plan for evaluating progress toward achieving project process and outcome objectives.

Does the applicant provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the cooperative agreement? Are the measures objective/quantitative and do they adequately measure the intended outcome?

Extent to which the line-item budget is detailed, clearly justified, and consistent with the purpose and objectives of this program.

Does the application adequately address the requirements of Title 45 CFR part 46 for the protection of human subjects? Not scored: however, an application can be disapproved if the research risks are sufficiently serious and protection against risks is so inadequate as to make the entire application unacceptable.

Does the application adequately address the requirements of PHS Policy on Humane Care and Use of Laboratory Animals?

Provide CDC with original plus two copies of:

1. Interim progress report, no less than 90 days before the end of the budget period. The progress report will serve as your non-competing continuation application, and must contain the following elements:

a. Current Budget Period Activity Objectives.

b. Current Budget Period Financial Progress.

c. New Budget Period Program Proposed Activity Objectives.

d. Detailed Line-Item Budget and Justification.

e. Additional Requested Information.

2. Financial status report, no more than 90 days after the end of the budget period.

3. Final financial and performance reports, no more than 90 days after the end of the project period.

Send all reports to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

The following additional requirements are applicable to this program. For a complete description of each, see Attachment I of the program announcement, as posted on the CDC Web site.

This and other CDC announcements, the necessary applications, and associated forms can be found on the CDC Web site, Internet address: http://www.cdc.gov . Click on “Funding” then “Grants and Cooperative Agreements.”

For general questions about this announcement, contact: Technical Information Management, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone: 770-488-2700.

For business management and budget assistance, contact: Lynn Walling, Contract Specialist, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone: 770-488-2612, E-mail Address: lqw5@cdc.gov .

For program technical assistance, contact: Mark L. Eberhard, Ph.D., Division of Parasitic Diseases, CDC, National Center for Infectious Diseases, 4770 Bufford Highway, NE., Atlanta, GA 30333, Telephone: 770-488-7791, E-mail Address: mlel@cdc.gov .

Application Deadline: June 20, 2003.

This program is authorized under section 311 of the Public Health Service Act, (42 U.S.C. 243), as amended and section 317 (k)(1) of the Public Health Service Act, (42 U.S.C. 247b(k)(1)), as amended. The Catalog of Federal Domestic Assistance number is 93.185.

The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2003 funds for a grant program for the coordination of activities between the National Immunization Program (NIP) and state and local public health immunization programs. This program addresses the “Healthy People 2010” focus areas of Immunization and Infectious Diseases.

The purpose of this program is to develop, establish, enhance, and manage an organizational network among immunization programs which would facilitate, coordinate, integrate, and expand state and local efforts to improve overall national immunization prevention programs. Specifically, the program will (1) maintain an effective communication capacity among the nation's immunization program managers and CDC; (2) establish a platform for integrated problem solving, national policy analysis and decision making among immunization program managers; and (3) establish a capacity to coordinate the consultations and collaborations that will enable state and local immunization programs to assimilate and implement the latest programmatic, scientific and technological developments and concepts affecting the goal of immunizing our nation's citizens.

Measurable outcomes of the program will be in alignment with NIP performance goals that apply to state and local public health immunization programs:

1. Reduce the number of indigenous cases of vaccine-preventable diseases.

2. Ensure that two year-olds are appropriately vaccinated.

In addition, focus should be placed on the “Healthy People 2010” goals to:

1. Increase routine vaccination coverage levels of adolescents.

2. Increase hepatitis B vaccine coverage among high-risk groups.

3. Increase the proportion of adults who are vaccinated annually against influenza and are vaccinated, as recommended, against pneumococcal disease.

Applications may be submitted by public or private national nonprofit organizations with a comprehensive state and local area representation of key officials who are actively engaged in directing immunization program efforts.

Assistance will be provided to one applicant that can demonstrate the ability to accomplish the objectives stated above. Applicant should be able to demonstrate ability to provide technical expertise in the areas of program management, vaccine management, information technology, quality assurance, health care delivery, health education and disease surveillance which is required to ensure effective implementation of population-based immunization programs.

Availability of Funds: Approximately $150,000 is available in FY 2003 to fund one award. It is expected that the award will begin on or about September 15, 2003, and will be made for a 12-month budget period within a project period of up to five years. Funding estimates may change.

Continuation awards within an approved project period will be made on the basis of satisfactory progress as evidenced by required reports and the availability of funds.

Use of Funds:

Funds cannot be used for construction or renovation, to purchase or lease vehicles or to purchase office space.

Recipient Financial Participation: No matching funds are required for this program.

In conducting activities to achieve the purpose of this program, the recipient will be responsible for the following activities:

1. Organize, establish and maintain liaison activities to collaborate with NIP and other affiliate organizations to attain national immunization goals.

2. Provide information on key immunization developments to state and local Immunization Program Managers, other key Immunization Program staff, and other organizations via newsletters, conference calls and other multimedia sources.

3. Develop and maintain a forum for state and local Immunization Program Managers to exchange epidemiologic and other programmatic information, respond to emerging issues, develop policy positions, and advise key officials, including CDC, on the prevention of Vaccine Preventable Diseases.

4. Sponsor and provide leadership for a nationally recognized forum ( i.e. , an annual meeting) for state and local immunization program managers across the nation in which to exchange and disseminate epidemiologic and other public health information, respond to emerging issues, develop and foster consistent state and local policy positions, and advise key officials, including CDC, on the prevention of Vaccine Preventable Diseases. Organize and convene meetings and workshops on an as needed basis for the purpose of exchanging information and program updates.

5. Identify and assess the immunization-related public health infrastructure needs of state and local Immunization Programs.

6. Assist in developing the agenda and selecting and obtaining speakers for the National Immunization Conference and the Annual Immunization Program Managers Meeting.

7. Promote the adequate and efficient allocation of resources to immunization efforts.

Letter of Intent (LOI): A LOI is optional for this program. The Program Announcement title and number must appear in the LOI. The narrative should be no more than two pages, single-spaced, printed on one side, with one-inch margins, and unreduced 12-point font. Your letter of intent will not be evaluated, but will be used to assist CDC in planning for the objective review for this program. The letter of intent should include the following information:

1. The name of the organization.

2. The primary contact person's name, mailing address, phone number, fax number and email address (if available).

3. The mission/activities of the organization.

4. The number of members in the organization.

Application: The Program Announcement title and number must appear in the application. Use the information in the Program Requirements, Other Requirements, and Evaluation Criteria sections to develop the application content. Your application will be evaluated on the criteria listed, so it is important to follow them in laying out your program plan. The narrative should be no more than 25 pages, double-spaced, printed on one side, with one-inch margins, and unreduced 12-point font.

The narrative should consist of, at a minimum, Background, a Program Plan, Objectives, Methods of Operation, Program Management, Evaluation Plan and Budget Information.

a. Provide background information on the applicant organization that includes evidence of relevant experience in coordinating activities among constituents and a clear statement of the purpose of the project.

b. A copy of the applicant organization's By-Laws and a list of the current office holders and Executive Committee members should be attached.

a. Provide a position description for all proposed staff.

b. Indicate the proposed location for the project.

c. Describe the problems to be addressed with the requested assistance and briefly propose a programmatic plan for each.

d. Provide a plan for disseminating reports of project activities indicating the frequency, timing, format and intended recipients of the reports.

a. Establish long-term (five years) and short-term (one year) objectives for the programmatic plan.

b. Objectives must be specific, realistic, measurable, and time-phased.

a. Describe the operational plan for achieving each objective established. Concisely describe each component or major activity and how it will be carried out.

b. Include a time-line for completing each component or major activity.

Describe the professional personnel involved in the management of this project and their qualifications.

Describe the plan for monitoring progress toward achievement of each of the objectives.

a. Provide a detailed budget with justification. The budget proposal should be consistent with the purpose and program plan.

b. Provide an itemized (line-item) budget categorized by objective.

On or before June 5, 2003, submit the LOI to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

Submit the signed original and two copies of PHS 5161-1 (OMB Numb 0920-0428). Forms are available in the application kit and at the following Internet address:

If you do not have access to the Internet, or if you have difficulty accessing the forms on-line, you may contact the CDC Procurement and Grants Office Technical Information Management Section (PGO-TIM) at: 770-488-2700. Application forms can be mailed to you.

The application must be received by 4 p.m. Eastern Time June 20, 2003. Submit the application to: Technical Information Management-PA03082, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146.

Forms must be submitted in the following order:

Applications may not be submitted electronically.

A postcard will be mailed by PGO-TIM, notifying you that CDC has received your application.

Letters of intent and applications shall be considered as meeting the deadline if they are received before 4 p.m. Eastern Time on the deadline date. Any applicant who sends their application by the United States Postal Service or commercial delivery services must ensure that the carrier will be able to guarantee delivery of the application by the closing date and time. If an application is received after closing due to (1) Carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time, or (2) significant weather delays or natural disasters, CDC will upon receipt of proper documentation, consider the application as having been received by the deadline.

Any application that does not meet the above criteria will not be eligible for competition, and will be discarded. The applicant will be notified of their failure to meet the submission requirements.

The Letter of Intent will not be evaluated, but will be used to assist in planning for the objective review of applications.

Applicants are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the grant. Measures of effectiveness must relate to the performance goals as stated in the purpose section of this announcement. Measures must be objective and quantitative and must measure the intended outcome. These measures of effectiveness shall be submitted with the application and shall be an element of evaluation.

An independent review group appointed by CDC will evaluate each application against the following criteria: (100 points maximum)

The extent to which the applicant documents experience in representing program officials who are actively engaged in directing immunization program efforts, in providing a national network of communications and support to state and local immunization programs, and in expanding national level partnerships to support the development of immunization staff and the enhancement of immunization program efforts.

The extent to which organization includes representatives of immunization programs who are actively engaged in directing immunization program efforts, and who represent state and local immunization program efforts from all parts of the nation.

Extent to which the applicant understands the requirements, problems, objectives, complexities, and interactions required of this project

Degree to which the proposed objectives are clearly stated, realistic, time phased, and related to the purpose of this project

The extent to which the applicant's plan to carry out the activities proposed is feasible and consistent with the stated objectives in this proposal. The extent to which the timetable incorporates major activities and milestones that are specific, measurable and realistic. Dates, tasks, and persons responsible for accomplishing tasks should be included.

Extent to which the professional personnel proposed to be involved in administering this project and the professional personnel proposed to provide program leadership have the capacity to perform the work proposed. This would include individual qualifications with evidence of past achievements for staff identified.

The extent to which the evaluation plan appears feasible for monitoring progress toward meeting the stated project objectives. In addition to evaluating outcome-related project objectives, the plan should clearly describe how the grantee will use performance measures to track internal processes.

The budget should be reasonable, clearly justified, and consistent with the intended use of funds.

The extent to which the application will further the NIP performance goals stated in the purpose section of this announcement.

Provide CDC with original plus two copies of:

1. Interim progress report, no less than 90 days before the end of the budget period. The progress report will serve as your non-competing continuation application, and must contain the following elements:

a. Current Budget Period Activities Objectives.

b. Current Budget Period Financial Progress.

c. New Budget Period Program Proposed Activity Objectives.

d. Detailed Line-Item Budget and Justification.

e. Additional Requested Information.

2. Financial status report, no more than 90 days after the end of the budget period.

3. Final financial and performance reports, no more than 90 days after the end of the project period.

Send all reports to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

The following additional requirements are applicable to this program. For a complete description of each, see Attachment I of the program announcement, as posted on the CDC Web site.

Executive Order 12372 does not apply to this program.

This and other CDC announcements, the necessary applications, and associated forms can be found on the CDC home page Internet address: http://www.cdc.gov.

Click on “Funding” then “Grants and Cooperative Agreements.”

For general questions about this announcement, contact: Technical Information Management, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone: (770) 488-2700.

For business management assistance, contact: Peaches Brown, Grants Management Specialist, Procurement and Grants Office, Centers for Disease Control and Prevention, 2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone number: (770) 488-2738, Email address: prb0@cdc.gov.

For program technical assistance, contact: Kenneth Sharp, Program Operations Branch, ISD, National Immunization Program, Mailstop E-52, 1600 Clifton Rd, Atlanta, GA 30333, Telephone number: (404) 639-8215, E-mail address: ksharp@cdc.gov.

Application Deadline: June 5, 2003.

This program is authorized under sections 317 and 2102 of the Public Health Service Act, 42 U.S.C. 247b and 300aa-2. The Catalog of Federal Domestic Assistance number is 93.185.

The Centers for Disease Control and Prevention announces the availability of fiscal year (FY) 2003 funds to initiate a cooperative agreement for surveillance for pertussis in a defined geographic area to better characterize the epidemiology of pertussis disease across pediatric, adolescent, and adult age groups and to link disease surveillance with immunization registry data to evaluate vaccine effectiveness. Moreover, as licensure and recommendation of an adolescent/adult pertussis vaccine may occur in the United States in the near future, studies of the impact of this new recommendation could be conducted in this study site. The “Healthy People 2010” focus area is Objective 14: Immunization and Infectious Disease including 14.1 (Reduce or eliminate indigenous cases of vaccine-preventable diseases) and 14.24 (Increase the proportion of young children and adolescents who receive all vaccines that have been recommended for universal administration for at least 5 years.)

The specific goals of this project include:

• Enhancing methods to evaluate the burden of pertussis disease across age groups.

• Developing improved methods for pertussis surveillance that could be applied in other areas.

• Evaluating the effectiveness of pertussis vaccination by linking disease surveillance with immunization registry data on vaccination coverage.

• Developing a study site that could be used to assess the impact of an adolescent/adult pertussis vaccine program.

Measurable outcomes of the program will be in alignment with the goals listed above.

The number of reported cases of pertussis in the United States has increased steadily from a historic low of 1,010 cases in 1976 to 7,867 cases in 2000. Despite high vaccination coverage in infants and children, pertussis is the only vaccine-preventable disease that has a reported increase in overall cases and infant mortality in the United States over the past decade. Adolescents and adults suffer significant morbidity; 12 percent to greater than 30 percent of persons with cough illness of at least one to two weeks duration have evidence of pertussis infection. The mean duration of cough in adolescents and adults has been estimated to be approximately eight weeks. It has been hypothesized that the incidence of pertussis in adolescents and adults is increasing and that this age group is a reservoir for circulation of Bordetella pertussis and transmission to infants, who have the highest morbidity and mortality.

The use of pertussis-containing vaccines has evolved since the first vaccine was licensed in the United States in 1914. Since becoming available in a combined vaccine with diphtheria and tetanus toxoids (DTP) in 1948, the vaccine has been widely used for routine childhood immunization. In 1991, acellular pertussis vaccine (DtaP) was introduced in the United States for the fourth and fifth booster dose. In 1997, DTaP was recommended for the entire five dose series (primary series plus booster doses) for children under six years of age. DTaP manufacturers and types have varied during their short history. Currently there are three different DTaP formulations (and one DTaP-HepB-IPV) available in the United States. Many children receive more than one formulation of DTaP over the five dose vaccine series. Because the efficacy of products may differ, evaluating product specific vaccine efficacy requires good data on the specific vaccine administered; these data may be available in a vaccination registry.

The current passive surveillance system for pertussis lacks sensitivity. Pertussis incidence is thought to be underestimated by at least one to two orders of magnitude in some age groups. Diagnostic criteria and reporting of pertussis vary significantly from state to state and from year to year. Outbreak investigations and the occurrence of periodic epidemic years can also markedly affect reporting. For example, among adolescents aged 15-19 years, the reported national incidence was 3.6 per 100,000 in 1999. By contrast, the reported incidence rate for adolescents aged 15-19 years in Massachusetts (which uses serologic testing for diagnosis in persons over the age of 11) was 65.6 per 100,000 in 1999. In the epidemic year 1996, Massachusetts reported an incidence rate of 103 per 100,000 for adolescents in the same age group. Current data for pertussis in adults is even more limited. Thus, the variability in diagnostic testing and reporting makes the interpretation of the true incidence and trends in pertussis challenging.

A better understanding of the age distribution, transmission, and disease burden is critical to implement and evaluate an adolescent/adult immunization program in the United States. The ability to link immunization registry data to disease surveillance is also critical to evaluate vaccine efficacy and to assess trends in vaccine coverage and disease burden.

Applications may be submitted by public and non-profit private organizations and by governments and their agencies.

Approximately $325,000 is available in FY 2003 to fund one award. It is expected that the award will begin on or before September 15, 2003 and will be made for a 12-month budget period. The overall project period is five years with funding in years two through five dependent on availability of funds and satisfactory progress achieving project goals.

Matching funds are not required for this program.

In conducting activities to achieve the purpose of this program, the recipient will be responsible for the activities under 1. Recipient Activities, and CDC will be responsible for the activities listed under 2. CDC Activities. The intention is for the Recipient and the CDC to work jointly and in collaboration in developing, executing and reporting on this project.

The following section describes the expected activities of the recipient:

a. Establish population-based active surveillance for pertussis in geographic area with a well-defined population of at least 200,000 persons. Reporting sources should include all sites that provide inpatient and outpatient care to children, adolescents, and young adults. These include but are not necessarily limited to hospitals; emergency departments; pediatric, family practice, and internal medicine physician offices; public health clinics; urgent care centers; schools; and college health centers. Methods should be implemented to assure timely reporting of suspected pertussis cases, potentially including routine periodic contacts with reporting sources. Data should be collected from all suspected cases such that the descriptive epidemiology, risk factors, clinical course, therapy, and outcome of infection can be determined.

b. Enhance availability and use of laboratory testing to confirm the diagnosis of pertussis.

A range of laboratory tests should be available to confirm a pertussis diagnosis ( e.g. , culture, polymerase chain reaction (PCR), and serology). Strategies to facilitate widespread testing should be implemented. These may include educating reporting sources of the value and availability of testing, providing tests at no cost to the patient; facilitating transport of clinical specimens to the laboratory; and timely reporting of results.

c. Enhance the quality and scope of immunization registries in the surveillance area.

Activities to enhance quality include enrolling non-participating providers by facilitating ease of participation, and educating providers regarding the advantages of participation.

d. The applicant is also invited to propose a methodology for a pertussis vaccine efficacy study or a case-control study of risk factors for infection that could be implemented in conjunction with surveillance.

If additional funding is identified, and at the discretion of CDC, epidemiological studies of risk factors or vaccine efficacy could be conducted as part of the scope of this project.

CDC staff will collaborate in the following activities:

a. Collaborate in the development of surveillance strategies including consultation with staff experts on the clinical and laboratory diagnosis of pertussis.

b. Perform confirmatory laboratory testing for a sample of positive or negative laboratory tests.

c. Support registry evaluation and enhancement through consultation with staff experts on enhanced registry systems including immunizations registry computer programming experts.

d. Collaborate in the development and implementation of research activities under this agreement.

e. CDC staff experts on pertussis will provide educational training on the epidemiology, diagnosis, and treatment of pertussis as well as the limitations of the current national passive surveillance system.

The Program Announcement title and number must appear in the applications. Use the information in the Program Requirements, Other Requirements, and Evaluation Criteria sections to develop the application content. Applications will be evaluated on the criteria listed, so it is important to address them when describing the program plan. The narrative should be no more than 20 single-spaced pages and be printed on one side, with one-inch margins and a 12-point unreduced font.

The narrative should consist of, at a minimum, a Plan, Objectives, Methods, Evaluation, and Budget. The plan should address activities to be conducted over the entire five-year project period.

Submit the signed original and two copies of PHS 398 (OMB Number 0925-0001). Adhere to the Errata Instruction Sheet (posted on the CDC web site) for PHS 398. Forms are available at the following Internet address: http://www.cdc.gov/od/pgo/forminfo.htm.

If you do not have access to the Internet, or if you have difficulty accessing the forms on-line, you may contact the CDC Procurement and Grants Office Technical Information Management Section (PGO-TIM) at: 770-488-2700. Application forms can be mailed to you.

The application must be received by 4 p.m. Eastern Time June 5, 2003. Submit the application to: Technical Information Management-PA# 03101, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146.

Applications may not be submitted electronically.

A postcard will be mailed by PGO-TIM, notifying you that CDC has received your application.

Letters of intent and applications shall be considered as meeting the deadline if they are received before 4 p.m. Eastern Time on the deadline date. Any applicant who sends their application by the United States Postal Service or commercial delivery services must ensure that the carrier will be able to guarantee delivery of the application by the closing date and time. If an application is received after closing due to (1) carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time, or (2) significant weather delays or natural disasters, CDC will upon receipt of proper documentation, consider the application as having been received by the deadline.

Any application that does not meet the above criteria will not be eligible for competition, and will be discarded. The applicant will be notified of their failure to meet the submission requirements.

Applicants are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the cooperative agreement. Measures of effectiveness must relate to the performance goals stated in section “B. Purpose” of this announcement. Measures must be objective and quantitative and must measure the intended outcome. These measures of effectiveness shall be submitted with the application and shall be an element of evaluation.

Applications will be evaluated against the following criteria by a peer review group appointed by CDC:

The extent to which applicant provides a clear description of how the tasks described in the recipient activities would be accomplished. Specifically: (a) Extent to which applicant identifies all potential reporting sites in the surveillance area and presents strategies to enlist broad participation; (b) extent to which applicant provides a quality strategy to assure timely reporting of suspected cases; and (c) extent to which applicant proposes a feasible plan to make laboratory testing services widely available and to assure their widespread use.

The extent to which applicant provides information on the previous experience of the organization and project personnel that reflects an ability to complete the tasks listed in the recipient activities. Specifically, experience in disease surveillance; experience working with public and private medical care providers and hospitals in the surveillance area; and experience conducting culture, PCR, and serological laboratory tests. If applicant is not a State or local health department, experience working with the health department to conduct public health surveillance or other activities.

The extent to which applicant provides information on the quality of culture, PCR and serological methods that would be used for pertussis diagnosis. If such testing is not done currently, extent to which applicant can document that the proposed method is sensitive and specific for pertussis infection.

Extent to which applicant documents presence of a functional immunization registry and the completeness of that registry. Quality of plans to enhance participation, completeness, and data accuracy.

The extent to which applicant describes a staffing plan that demonstrates their understanding of the labor requirements to complete this scope of work and a management plan that describes their approach to managing this work, including subcontract management, if applicable. Includes identifying key staff, their roles and responsibilities, and their professional experience (curricula vitae should be supplied in appendices).

The extent to which the applicant demonstrates an understanding of the rationale of active surveillance for pertussis, the importance of laboratory testing to confirm diagnoses, and the role of immunization registries in assessing vaccine-specific coverage and facilitating epidemiological studies.

The extent to which the applicant describes the surveillance area; documents a population of greater than 200,000 persons; and describes the demographic characteristics of the study population. The extent to which the surveillance population reflects that of the United States.

The application should also adequately address the requirements of 45 CFR part 46 for the protection of human subjects. This should include the provision of the FWA number from the Office of Human Research Projection (OHRP).

The applicant shall describe their proposed plan for managing the resources necessary to comply with the requirements specified in Section D. This shall include a description of the proposed person hours for each key individual.

The grantee will provide CDC with the original plus two copies of:

1. Semi-annual progress reports. The results of the measures of effectiveness shall be a data requirement to be submitted with or incorporated into the progress report.

2. Financial status report, no more than 90 days after the end of the budget period.

3. Final financial report and performance report, no more than 90 days after the end of the project period.

Send all reports to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

The following additional requirements are applicable to this program. For a complete description of each, see Attachment 1 of the announcement as posted on the CDC Web site.

Executive Order 12372 does not apply to this program.

This and other CDC announcements, the necessary applications, and associated forms can be found on the CDC home page Internet address— http://www.cdc.gov .

Click on “Funding” then “Grants and Cooperative Agreements.”

For general questions about this announcement, contact: Technical Information Management, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone: 770-488-2700.

For business management and budget assistance contact: Peaches Brown, Grants Management Specialist, Procurement and Grants Office, Centers for Disease Control and Prevention, 2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone number: (770) 488-2738, E-mail address: PRB0@cdc.gov.

For program technical assistance, contact: Gregory S. Wallace, M.D., Epidemiology and Surveillance Division, National Immunization Program, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, Mailstop E-61, Atlanta, GA 30333, Telephone number: (404) 639-8715, E-mail address: gsw2@cdc.gov.

This program is authorized under sections 301, 307, and 317 of the Public Health Service Act, (42 U.S.C. 241, 2421, and 247b), as amended. The Catalog of Federal Domestic Assistance number is 93.283.

The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2003 funds for a grant program to design an appropriate approach for strengthening blood transfusion services and blood safety in Tanzania.

The purpose of the program is to assess key needs and resources and to make recommendations for strengthening blood supply and transfusion services in Tanzania. This program is being performed specifically in Tanzania according to U.S. Congressional mandate for Department of State, United States Agency for International Development (USAID) implementation in response to the 1998 bombing of the U.S. embassy in Tanzania.

On August 7, 1998, terrorists carried out nearly simultaneous bombings of the U.S. Embassies, which were located in a residential area of Dar Es Salaam, Tanzania, and in downtown Nairobi, Kenya. Taken together, these bombings had their intended terrorist and disastrous effect: the occurrence of a large number of premature deaths, disabling injuries, and post-traumatic psycho-social stress among the victims directly affected and among their families and co-workers. In addition to an enormous adverse impact on innocent people, the bombings caused substantial damage to property and also revealed widespread weaknesses in the disaster preparedness, management, and response capabilities, including blood transfusion services.

In October 1998, at the request of President Clinton and Dr. Donna Shalala, then Secretary of the U.S. Department of Health and Human Services (HHS), Surgeon General Dr. David Satcher and a team of experts traveled to Kenya and Tanzania. Dr. Satcher and his team visited the bombing sites, bombing victims, and Tanzanian Government institutions and non-governmental organizations responsible for disaster management and Emergency Medical Services. The Surgeon General reported to the Secretary of DHHS that there was a need for two to three years of focused activities in which HHS agencies could collaborate with USAID and other stakeholders to assist Tanzanians.

This project for designing an appropriate approach for strengthening blood transfusion services in Tanzania is part of a larger CDC program for strengthening emergency medical preparedness in the nation of Tanzania. Measurable outcomes of this project will be in alignment with that program.

Assistance will be provided to a public, private, for-profit, or non-profit organization (including faith-based organizations) that has at least one major operation headquartered in sub-Saharan Africa. Eligible organizations will have significant experience in building, operating, and transferring blood services in sub-Saharan Africa.

Competition is being limited to organizations with an established presence in sub-Saharan Africa due to an acute urgency to begin the project in response to recent increases in terrorist activity in the region.

Approximately $15,000 is available in FY 2003 to fund one award. It is expected that the award will begin on or about September 15, 2003 and will be made for a 12-month budget period within a project period of up to one year. Funding estimates may change.

1. Funds may be spent for reasonable program purposes, including personnel, travel, supplies, and services. Equipment may be purchased if deemed necessary to accomplish program objectives; however, prior approval by CDC officials must be requested in writing.

2. All requests for funds contained in the budget, shall be stated in U.S. dollars. Once an award is made, CDC will not compensate foreign grantees for currency exchange fluctuations through the issuance of supplemental awards.

3. The costs that are generally allowable in grants to domestic organizations are allowable to foreign institutions and international organizations, with the following exception: With the exception of the American University, Beirut, and the World Health Organization, Indirect Costs will not be paid (either directly or through sub-award) to organizations located outside the territorial limits of the United States or to international organizations regardless of their location.

4. The applicant may contract with other organizations under this program; however the applicant must perform a substantial portion of the activities (including program management and operations, and delivery of prevention services for which funds are required.)

5. The applicant must obtain annual audit of these CDC funds (program-specific audit) by a U.S.-based audit firm with international branches and current licensure/authority in-country, and in accordance with International Accounting Standards or equivalent standard(s) approved in writing by CDC.

6. A fiscal Recipient Capability Assessment may be required, prior to or post award, in order to review the applicant's business management and fiscal capabilities regarding the handling of U.S. Federal funds.

Recipient Financial Participation: Matching funds are not required for this program.

In conducting activities to achieve the purpose of this program, the recipient will be responsible for the following activities:

a. Review current literature and documentation related to blood management in Tanzania.

b. Develop and organize an assessment plan.

c. Perform an in-country assessment of blood management in Dar es Salaam, Tanzania, for a duration of not less than one week, and not more than two weeks.

d. Review and disseminate the assessment findings to Tanzanian health officials and CDC.

A LOI is not required for this program.

The Program Announcement title and number must appear in the application. Use the information in the Program Requirements, Other Requirements, and Evaluation Criteria sections to develop the application content. Your application will be evaluated on the criteria listed, so it is important to follow them in laying out your program plan. The narrative should be no more than twenty pages, double-spaced, printed on one side, with one-inch margins, and unreduced 12-point font.

The narrative should consist of, at minimum, a plan, objectives, methods, evaluation, and budget. Provide a detailed budget and justification based on the funds available.

Submit the signed original and two copies of PHS 5161-1 (OMB Number 1920-0428). Forms are available at the following Internet address: www.cdc.gov/od/pgo/forminfo.htm.

If you do not have access to the Internet, or if you have difficulty accessing the forms on-line, you may contact the CDC Procurement and Grants Office Technical Information Management Section (PGO-TIM) at: 770-488-2700. Application forms can be mailed to you.

The application must be received by 4 p.m. Eastern Time July 7, 2003. Submit the application to: Technical Information Management-PA#03047, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146.

Applications may not be submitted electronically.

A postcard will be mailed by PGO-TIM, notifying you that CDC has received your application.

Applications shall be considered as meeting the deadline if they are received before 4 p.m. Eastern Time on the deadline date. Any applicant who sends their application by the United States Postal Service or commercial delivery services must ensure that the carrier will be able to guarantee delivery of the application by the closing date and time. If an application is received after closing due to (1) carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time, or (2) significant weather delays or natural disasters, CDC will upon receipt of proper documentation, consider the application as having been received by the deadline.

Any application that does not meet the above criteria will not be eligible for competition, and will be discarded. The applicant will be notified of their failure to meet the submission requirements.

Applicants are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the grant. Measures of effectiveness must relate to the performance goals stated in the purpose section of this announcement. Measures must be objective and quantitative and must measure the intended outcome. These measures of effectiveness must be submitted with the application and will be an element of evaluation.

An independent review group appointed by CDC will evaluate each application against the following criteria:

a. Provide evidence of demonstrated scientific expertise involving programs for the promotion of public health in sub-Saharan Africa.

b. Provide evidence of demonstrated technical expertise in developing blood transfusion and blood safety systems to include methods that are culturally and technologically appropriate to sub-Saharan Africa.

a. Provide evidence of demonstrated expertise in methodology for evaluation and development of national blood safety and management systems.

b. Demonstrate experience in providing staff training, strategic planning, test kits, testing services, and operations planning in sub-Saharan Africa.

c. Provide evidence of demonstrated successful experience involving blood management services in developing nations of sub-Saharan Africa.

Provide evidence of demonstrated technical expertise and professional experience of staff in the evaluation, organization, and management of blood transfusion services in an African nation. Provide evidence that management staff has ample experience in blood banking in Africa. Provide assurance that the team will be headed by an MD from sub-Saharan Africa and that the staff includes physicians with expertise in hematology, blood transfusion, and infectious diseases.

Provide evidence of demonstrated successful experience as a consultant in sub-Saharan African countries.

a. Demonstrated clarity, feasibility, and practicality of the proposed plan to accomplish this project.

b. Demonstrated recognition of the potential difficulties in performance and appropriateness and soundness of proposed solutions.

The extent to which the budget is clearly explained, adequately justified, and is reasonable and consistent with the stated objectives and planned activities.

Provide CDC with original plus two copies of a final financial report and a final report of findings and recommendations. These reports are due no more than 90 days after the end of the project period.

Send all reports to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

The following additional requirements are applicable to this program. For a complete description of each, see Attachment I of the program announcement, as posted on the CDC Web site.

Executive Order 12372 does not apply to this program.

This and other CDC announcements, the necessary applications, and associated forms can be found on the CDC Web site, Internet address: http://www.cdc.gov .

Click on “Funding” then “Grants and Cooperative Agreements”.

For general questions about this announcement, contact: Technical Information Management, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone: 770-488-2700.

For business management and budget assistance, contact: Angelia Hill, Grants Management Specialist, Procurement and Grants Office, Centers for Disease Control and Prevention, 2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone: 770-488-2785, E-mail address: AHill@cdc.gov .

For program technical assistance, contact: Mark Keim, MD, International Emergency and Refugee Health Branch, National Center for Environmental Health, Centers for Disease Control and Prevention, Mail Stop F-48, 4770 Buford Highway, Atlanta, GA 30341, Telephone: 770-488-4597, E-mail address: MKeim@cdc.gov .

Application Deadline: July 7, 2003.

This program is authorized under section 301(a) and 317(k)(1) and 317(k)(2) of the Public Health Service Act, (42 U.S.C. 241(k) and 247b(k)(1) and 247(k)(2)), as amended. The Catalog of Federal Domestic Assistance number is 93.283.

The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2003 funds for a cooperative agreement program to develop, implement and evaluate health education activities to prevent and control viral hepatitis and its consequences. This program addresses the “Healthy People, 2010” focus area of Immunization and Infectious Diseases.

The purpose of the program is to develop, implement and evaluate health educational activities that result in the prevention of infections with hepatitis viruses. The goals of these activities are to increase knowledge, change attitudes and practices (KAP) that should result in the prevention and control of viral hepatitis among health professionals, high-risk populations, and the general public.

These activities are part of a comprehensive, national educational strategy to prevent and control viral hepatitis by changing behaviors that put persons at risk for acquiring these infections and increasing behaviors that prevent these infections. This comprehensive approach includes, but is not limited to, print, video and web-based health education tools, multi-media activities directed at populations at increased risk of infection, and curricula to train health care providers and counselors. Applicants should include formative, process and outcome evaluation methodologies in their comprehensive application.

This announcement has four distinct Parts. Applicants wishing to apply for more than one Part must submit a complete application for each Part.

The objective of Part A is to support up to six applicants to develop, implement and evaluate comprehensive communication strategies that target (1) men who have sex with men (MSM) who are at risk for hepatitis A and B; (2) injection drug users (IDUs) who are in or out of treatment and who are at risk for hepatitis A, B, and C; (3) men, women and juveniles who are incarcerated and who are at risk for hepatitis A, B, and C; (4) minority populations disproportionately infected with hepatitis A, B, and/or C viruses; and (5) other populations at increased risk for viral hepatitis. Applicants for Part A may apply to develop educational activities for more than one primary target population, but must include justification that the applicant has expertise in working with each primary target population(s). The applicant must provide a complete application that addresses development, implementation and evaluation for each target population and the specific viral hepatitis infection(s) that the applicant chooses to address.

The objective of Part B is to support one applicant to further develop, implement and evaluate an existing curriculum that could be used nationally to train health professionals, including those in training programs, in the prevention, management, and control of viral hepatitis. This curriculum should contain client-centered counseling as a major component.

The objective of Part C is to support up to two applicants to develop, implement and evaluate training programs or activities ( e.g. , meetings, symposia, seminars, distance learning) for health professionals to prevent and control viral hepatitis. The training format must address the integration of all aspects of viral hepatitis prevention into existing public health ( e.g. , STD, HIV/AIDS), substance abuse or clinical care ( e.g. , corrections, primary care) programs.

The objective of Part D is to support one applicant to develop, implement, and evaluate educational tools that promote hepatitis A and hepatitis B vaccination. These tools might include, but are not limited to, brochures, newsletters, fact sheets, reports, Web site information, and manuals that provide public and provider education relative to the importance of hepatitis A and hepatitis B vaccination practices.

Measurable outcomes of the program will be in alignment with one or more of the following performance goals for the National Center for Infectious Diseases (NCID): Protect Americans from infectious diseases.

Applications may be submitted by public and private nonprofit organizations and by governments and their agencies; that is:

Approximately $800,000 is available in FY 2003 for Part A to fund approximately six awards, approximately $300,000 is available in FY 2003 for Part B to fund one award, approximately $300,000 is available in FY 2003 for Part C to fund two awards, and approximately $300,000 is available in FY 2003 for Part D to fund one award. It is expected that the average award for Part A will be $130,000, ranging from $50,000 to $250,000 and it is expected that the average award for Part C will be $150,000, ranging from $100,000 to $200,000. It is expected that the awards will begin on or about September 15, 2003 and will be made for a 12-month budget period within a project of up to five years for Parts A and D and up to three years for Parts B and C. Funding estimates may change.

Continuation awards within an approved project period will be made on the basis of satisfactory progress toward stated goals and objectives and the availability of funds.

Matching funds are not required for this program.

Preference will be given to applicants currently involved in devoting all or some of their activities and resources to educating the public, patients, and/or health professionals about the prevention and control of viral hepatitis and viral-hepatitis-related liver disease, or currently are devoting a major portion of their activities to educating the public, patients, and/or health professionals about the prevention and control of other blood-borne viral infections, vaccine-preventable diseases, or sexually transmitted diseases, and could readily expand to address viral hepatitis.

In conducting activities to achieve the purpose of this program, the recipient will be responsible for the activities listed in 1. Recipient Activities, and CDC will be responsible for the activities listed in 2. CDC Activities.

Applicants must indicate for which Part they intend to seek funding under this agreement and submit a complete application for each Part.

All educational activities developed through this cooperative agreement should incorporate information on viral hepatitis, which is consistent with current and future published CDC guidelines on prevention and control of hepatitis A, B, and C as contained in Attachment II (as posted on the CDC web site).

a. Develop, implement, and evaluate educational activities that target (1) men who have sex with men (MSM) who are at risk for hepatitis A and B; (2) injection drug users (IDUs) who are in or out of treatment and who are at risk for hepatitis A, B, and C; (3) men, women and juveniles who are incarcerated and who are at risk for hepatitis A, B, and C; (4) minority populations disproportionately infected with hepatitis A, B, and/or C viruses; and (5) other populations at increased risk for viral hepatitis. In their application, applicants must show that they have expertise working with the population(s) they are addressing in their project proposal.

b. Indicate what type(s) of educational activities are considered to best reach the target audience. Based upon available data or data to be acquired by a needs assessment, develop, implement and evaluate a comprehensive approach to educational activities intended to reach the targeted audiences. This approach should have a strong KAP assessment component.

c. Describe what linkages with state or local hepatitis C and hepatitis B coordinators and STD, HIV, drug treatment, juvenile and adult corrections programs will be established and describe the best approaches for the delivery of viral hepatitis educational activities.

d. Describe how the activities developed in the proposal would incorporate information on viral hepatitis, which is consistent with published CDC guidelines on the prevention and control of hepatitis A, B, and C (see references in Attachment II).

e. Describe the plan for production and distribution of materials developed in the project.

f. Indicate the formative, process and outcome evaluations included for each educational activity.

a. Further develop an existing curriculum that could be used nationally to train health professionals, including those in training, in the prevention, management, and control of viral hepatitis.

b. Provide a curriculum that can be integrated into existing or ongoing training programs and that could be utilized in settings that provide services for patients who are at increased risk for viral hepatitis ( e.g. , STD clinics, HIV counseling and testing sites, drug treatment centers, community health centers). This curriculum should address viral hepatitis A, B, and C prevention and highlight client-centered counseling messages.

c. Formative, process and outcome evaluation methodologies should be developed and applied to assess the utility and usability of the curriculum.

d. The curriculum should be produced and made available to governmental and non-governmental organizations nationwide.

a. Support education and training programs for health professionals who work with individuals at increased risk for viral hepatitis.

b. Develop and conduct training programs for health professionals related to the integration of viral hepatitis prevention and control into various public health and clinical settings that serve persons at increased risk of viral hepatitis.

c. Direct training programs to a wide range of health professionals ( e.g. , physicians, nurses, counselors) from both governmental and private entities.

d. Conduct the training programs using several formats ( e.g. , meetings, symposia, seminars, distance learning) and make the curriculum and training formats available nationwide through a Web site and/or through printed materials.

e. Evaluate the program(s) through formative, process and outcome measures.

a. Develop, implement and evaluate educational tools that promote hepatitis A and hepatitis B vaccination of children, adolescents and adults. These tools might include, but are not limited to, information brochures/booklets, newsletters, manuals, reports, videos, and Web site information. The educational tools should target health professionals and the general public.

b. Evaluate the tools using formative, process and outcome measures.

a. Provide scientific and public health consultation and assistance in the development of educational activities related to the cooperative agreement.

b. Provide consultation and technical assistance regarding implementation of educational activities.

c. Provide technical assistance in the development and implementation of formative, process and outcome evaluation plans.

d. Assist in reporting and validating relevant information concerning viral hepatitis made available to Federal, State, local health agencies, health professionals, and volunteer organizations.

An LOI is optional for this program. The Program Announcement title and number must appear in the LOI. The narrative should be no more than five pages, double-spaced, printed on one side, with one-inch margins, and unreduced 12-point font. Your letter of intent will be used to assist CDC in planning and executing the evaluation of applications submitted under this announcement, and should include the following information: name and address of institution; name, address, and telephone number of the contact person; and a brief description of intended effort. This description should include to which Part(s) the applicant is applying and which primary target population(s) the applicant is addressing. Each applicant must submit a separate LOI for each Part.

The Program Announcement title and number must appear in the application. Use the information in the Program Requirements, Other Requirements and Evaluation Criteria sections to develop the application content. Separate applications for each Part must be submitted. Your application will be evaluated on the criteria listed, so it is important to follow them in laying out your program plan. The narrative should be no more than 25 pages, double-spaced, printed on one side, with one-inch margins, and unreduced 12-point font.

The narrative should consist of, at a minimum, a description of the overall plan to achieve the objectives, methods, evaluation and budget. The plan should address activities to be conducted over the entire project period. A detailed index to application contents, including appendices, as well as a one-page executive summary should be included at the front of the application and included in the 25 page limit.

On or before June 5, 2003, submit the LOI to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

Submit the signed original and two copies of PHS 398 (OMB number 0925-0001). Adhere to the instructions on the Errata Instruction Sheet (posted on the CDC web site) for PHS 398. Forms are available at the following Internet address: http://www.cdc.gov/od/pgo/forminfo.htm.

If you do not have access to the Internet, or if you have difficulty accessing the forms on-line, you may contact the CDC Procurement and Grants Office Technical Information Management Section (PGO-TIM) at: 770-488-2700. Application forms can be mailed to you.

The application must be received by 4 p.m. Eastern Time July 7, 2003. Submit the application(s) to: Technical Information Management-PA#03099, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146.

Applications may not be submitted electronically.

A postcard will be mailed by PGO-TIM, notifying you that CDC has received your application.

Letters of intent and applications will be considered as meeting the deadline if they are received before 4 p.m. Eastern Time on the deadline date. Any applicant who sends their application by the United States Postal Service or commercial delivery services must ensure that the carrier will be able to guarantee delivery of the application by the closing date and time. If an application is received after closing due to (1) carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time, or (2) significant weather delays or natural disasters, CDC will upon receipt of proper documentation, consider the application as having been received by the deadline.

Any application that does not meet the above criteria will not be eligible for competition and will be discarded. The applicant will be notified of their failure to meet the submission requirements.

Applicants are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the cooperative agreement. Measures of effectiveness must relate to the performance goal as stated in purpose section of this announcement. Measures must be objective and quantitative and must measure the intended outcome. These measures of effectiveness must be submitted with the application and will be an element of evaluation.

An independent review group appointed by CDC will evaluate each application against the following criteria:

a. Extent to which the applicant describes objectives of the proposed activities which are (1) consistent with the purpose and goal of this cooperative agreement, (2) measurable and time-phased and (3) consistent with published CDC guidelines on prevention and control of hepatitis A, B, and C (see cited references in Attachment II).

b. Extent and quality of detailed plan proposed for designing, implementing, and evaluating the activities, which clearly and appropriately addresses all “Recipient Activities” in the application, and are appropriate and adequate to accomplish the objectives. These activities will be scored in four categories as follows:

(1) Methodologies used in the development of the activity. Methodologies should be based on established learning theories such as, but not limited to, adult learning theory, social learning theory, and/or behavioral change theory that include the health belief model and stages of change. The established objectives must be measurable and meet the broad goals of the application.

(2) The planning and development process. The process should include formative evaluation ( e.g. , needs assessment) that clearly shows the need and structure of the plan for the specific educational activity.

(3) Implementation of educational activities. A complete description of implementation methodology should be included that describes the process evaluation throughout the implementation phase. Process evaluation during the development of the activity should directly address the planned activity and should be conducted (a) to assure that the educational activity is being implemented as intended and (b) to determine if the educational activity needs to be modified to better address the educational needs of the target population as outlined in the objectives.

(4) The expected outcome. Impact evaluation should be assessed to determine if the objectives ( e.g. , change in KAPs) were met as a result of implementing the activity. A description of the standards ( e.g. , scientific, historical, normative) to which the results will be compared should be included. Outcome evaluation should contain an assessment of the resultant policy changes or organizational practices ( e.g. , extended/expanded use of the educational activity) after implementing the activity.

c. Extent to which the applicant clearly identifies specific assigned responsibilities of all key professional personnel, and describes collaboration with CDC and other relevant organizations.

d. The degree to which the applicant has met the CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed activities. This includes: (1) The proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation; (2) The proposed justification when representation is limited or absent; (3) A statement as to whether the plans for recruitment and outreach for participants include the process of establishing partnerships with communities and recognition of mutual benefits.

Extent to which the applicant provides evidence of adequate resources, facilities, experience (both technical and administrative), and access to target audiences for conducting the activities.

This should include:

a. Documentation that professional personnel involved are qualified and have past successful experience and achievements related to the proposed activities; this can include experience of either direct or collaborating personnel in providing viral hepatitis or other communicable disease ( e.g. , HIV) education and/or training in prevention and control activities.

b. Inclusion of original letters of support from appropriate non-applicant organizations, individuals, institutions, academic institutions, public health departments, etc. needed to carry out proposed activities and the extent to which such letters clearly indicate the author's commitment to participate as described in the plan.

c. Evidence of past success in developing, disseminating and evaluating health education activities.

d. Extent of demonstrated experience in areas of viral hepatitis or other blood-borne virus prevention and control and education and demonstrated success in developing, implementing, and evaluating the impact of educational activities in disease prevention/health promotion at different levels ( e.g. , community, high-risk populations, minority populations, patients, health professionals). Extent of demonstrated access to target populations, and successful collaborations with a variety of organizations such as government, non-government, private, non-profit, academic, and evidence of existing quality assurance mechanisms to ensure appropriate and culturally sensitive health educational services as recommended for the proposed audiences ( i.e. , MSM, IDUS, inmates of correctional facilities, health professionals and other populations at high-risk for viral hepatitis infections).

Extent to which the applicant demonstrates a clear understanding of the subject area and responds to the purpose and objectives of this cooperative agreement, including collaboration in all aspects of the agreement with CDC program staff and other relevant organizations.

Does the applicant provide Measures of Effectiveness that will demonstrate the accomplishment of the various identified objectives of the grant? Are the measures objective/quantitative and do they adequately measure the intended outcome?

The budget will be reviewed to determine the extent to which it is reasonable, clearly justified, and consistent with the intended use of funds.

a. Submit line item itemized budget with narrative justification for personnel, travel, supplies, and other services related to the project.

b. Funding levels for years two, three, four and five should be estimated for Parts A and D and for years two and three for Parts B and C.

Does the application adequately address the requirements of Title 45 CFR part 46 for the protection of human subjects? An application can be disapproved if the research risks are sufficiently serious and protection against risks is so inadequate as to make the entire application unacceptable.

Provide CDC with original plus two copies of:

1. Interim progress report, no less than 90 days before the end of the budget period. The progress report will serve as your non-competing continuation application and must include the following elements:

a. Current Budget Period Activities Objectives.

b. Current Budget Period Financial Progress.

c. New Budget Period Program Proposed Activity Objectives.

d. Detailed Line-Item Budget and Justification.

e. Additional Requested Information.

2. Financial status report, no more than 90 days after the end of the budget period.

3. Final financial and performance reports, no more than 90 days after the end of the project period.

Send all reports to the Grants Management Specialist identified in the “Where To Obtain Additional Information” section of this announcement.

The following additional requirements are applicable to this application. For a complete description of each, see Attachment I of the program announcement as posted on the CDC Web page.

This and other CDC announcements, the necessary applications, and associated forms can be found on the CDC Web site, Internet address: http://www.cdc.gov.

Click on “Funding” then “Grants and Cooperative Agreements”.

For general questions about this announcement, contact: Technical Information Management, CDC Procurement and Grants Office, 2920 Brandywine Rd, Atlanta, GA 30341-4146, Telephone: 770-488-2700.

For business management and budget assistance, contact: Merlin Williams, Grants Management Specialist, Procurement and Grants Office, Centers for Disease Control and Prevention, 2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone: 770-488-2765, E-mail address: mqw6@cdc.gov.

For business management and budget assistance in the Territories, contact: Steward Nichols, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone: 770-488-2788, E-mail address: shn8@cdc.gov.

For program technical assistance, contact: Linda Moyer, Chief, Education and Communication Team, Division of Viral Hepatitis, Centers for Disease Control and Prevention, 1600 Clifton Road, MS G-37, Atlanta, GA 30333, Telephone: 404-371-5900, E-mail address: lam1@cdc.gov.

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 : Endocrinologic and Metabolic 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 June 10, 2003, from 8:30 a.m. to 5 p.m.

Location : Holiday Inn, Versailles Ballrooms, 8120 Wisconsin Ave., Bethesda, MD.

Contact Person : Dornette Spell-LeSane, 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: spelllesaned@cder.fda.gov, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12536. Please call the Information Line for up-to-date information on this meeting.

Agenda : The committee will discuss supplemental new drug application (sNDA) 19-604/S-033, HUMATROPER (somatropin recombinant deoxyribonucleic acid (rDNA) origin) for injection), Eli Lilly and Co., for the proposed indication of treatment of nongrowth hormone deficiency short stature.

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 by June 3, 2003. Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2:30 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before June 3, 2003, 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.

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 Dornette Spell-LeSane 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).

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 : Nonprescription 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 June 12, 2003, from 8 a.m. to 5 p.m. Interested persons and organizations may submit written or electronic comments until August 1, 2003, to the Dockets Management Branch (see Addresses ).

Addresses : Electronic comments should be submitted to http://www.fda.gov/dockets/ecomments. Select “03N-0143—Continued over-the-counter status of ipecac syrup” and follow the prompts to submit your statement. Written comments should be submitted to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

Location : Holiday Inn, Versailles Ballrooms, 8120 Wisconsin Ave., Bethesda, MD.

Contact Person : Karen M. Templeton-Somers, 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, or e-mail: SomersK@cder.fda.gov, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area) code 12541. Please call the Information Line for up-to-date information on this meeting.

Agenda : The committee will consider the safety and efficacy of ipecac syrup, indicated for emergency use to cause vomiting in poisoning, for continued over-the-counter (OTC) status under 21 CFR 201.308. The primary areas of consideration are: (1) The status of the role of ipecac syrup in gastrointestinal decontamination; (2) whether the literature clearly defines the risk/benefit ratio of ipecac syrup; (3) the role of ipecac syrup in poison treatment for populations with limited access to emergency medical treatment; (4) if there is significant abuse of ipecac syrup; and (5) alternative therapies to ipecac syrup.

The background material will become available no later than the day before the meeting and will be posted under the Nonprescription Drugs Advisory Committee (NDAC) docket site at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm. (Click on the year 2003 and scroll down to NDAC meetings.)

Procedure : Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions for discussion or presentation at the meeting may be made to the contact person by June 5, 2003. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before June 5, 2003, 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. However, until August 1, 2003, other submissions containing the docket number 03N-0143 and information relevant to the may be submitted for consideration to Dockets Management Branch (see Addresses ).

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 Karen Templeton-Somers 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).