Title: Certificate for Poultry and Hatching Eggs for Export.

OMB Number: 0579-0048.

Type of Request: Extension of approval of an information collection.

Abstract: Under the Animal Health Protection Act (7 U.S.C. 8301-8317), the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA), among other things, collects information and conducts inspections to ensure that poultry and hatching eggs exported from the United States are free of communicable diseases. The export of agricultural commodities, including poultry and hatching eggs, is a major business in the United States and contributes to a favorable balance of trade. Receiving countries have specific health requirements for poultry and hatching eggs exported from the United States. Most countries require a certification that our poultry and hatching eggs are free of diseases of concern to the receiving country. This certification generally must carry the USDA seal and be endorsed by an authorized APHIS veterinarian.

Veterinary Services Form 17-6, Certificate for Poultry and Hatching Eggs for Export, is used to meet these requirements.

We are asking the Office of Management and Budget (OMB) to approve our use of this information collection activity for an additional 3 years.

The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:

(1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;

(2) Evaluate the accuracy of our estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;

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

(4) Minimize the burden of the collection of information on those who are to respond, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies; e.g. , permitting electronic submission of responses.

Estimate of burden: The public reporting burden for this collection of information is estimated to average 0.5 hours per response.

Respondents: Owners of poultry and hatching egg operations, exporters of poultry products, and accredited veterinarians.

Estimated annual number of respondents: 300.

Estimated annual number of responses per respondent: 70.

Estimated annual number of responses: 21,000.

Estimated total annual burden on respondents: 10,500 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)

All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

Title: Importation of Hass Avocados from Mexico.

OMB Number: 0579-0129.

Type of Request: Extension of approval of an information collection.

Abstract: The Plant Protection Act (7 U.S.C. 7701-7772) authorizes the Secretary of Agriculture to regulate the importation of plants, plant products, and other articles into the United States to prevent the introduction of plant pests and noxious weeds.

The regulations in “Subpart-Fruits and Vegetables” (7 CFR 319.56 through 319.56-8) allow the importation of Hass avocados from Michoacan, Mexico, into the United States, including 31 States and the District of Columbia, under certain conditions. The regulations require the use of permits, cooperative agreements, phytosanitary certificates, and box marking to indicate the States where distribution is prohibited.

We are asking the Office of Management and Budget (OMB) to approve our use of these information collection activities for an additional 3 years.

The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:

(1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;

(2) Evaluate the accuracy of our estimate of the burden of the information collection, including the validity of the methodology and assumptions used;

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

(4) Minimize the burden of the information collection on those who are to respond, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies, e.g. , permitting electronic submission of responses.

Estimate of burden: The public reporting burden for this collection of information is estimated to average 0.00006633 hours per response.

Respondents: Mexican plant health officials; importers, shippers, distributors, and handlers of fresh Hass avocados imported from Michoacan, MX, into the United States.

Estimated annual number of respondents: 3,058.

Estimated annual number of responses per respondent: 23,780.754.

Estimated annual number of responses: 72,721,546.

Estimated total annual burden on respondents: 4,823 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)

All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

The regulations in 7 CFR part 340, “Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is Reason to Believe Are Plant Pests,” (referred to below as the regulations) regulate, among other things, the introduction (importation, interstate movement, or release into the environment) of organisms and products altered or produced through genetic engineering that are plant pests or that there is reason to believe are plant pests. Such genetically engineered organisms and products are considered “regulated articles.”

Field tests of genetically engineered crops planted under an Animal and Plant Health Inspection Service (APHIS) permit as plant-made pharmaceuticals (PMPs) and plant-made industrials (PMIs) are currently being conducted under the regulations. In order to provide a forum for the discussion of past and current information relevant to biological and physical factors that influence the design, implementation, efficacy, and feasibility of measures used to confine transgenic plants and their progeny to the authorized field sites, APHIS is organizing a workshop. This workshop will provide a forum for discussing measures that can be taken to limit gene flow beyond the authorized site, commingling with other crops, and persistence of transgenic plants in the environment following termination of the field trial. The workshop will primarily focus on plants most frequently used as PMPs and PMIs, such as corn, barley, rice, safflower, and tobacco, with three break-out groups that will examine wind pollination of crops using corn as a model, self-pollinated crops using rice as a model, and insect-pollinated crops using safflower as a model.

This workshop is scheduled for September 13 through 15, 2004. The sessions on the first 2 days of the workshop will include panels of invited scientific experts. The third day will be open to the public and the results of the panel discussions will be summarized. Preregistration is required for all those who wish to attend the third day of the workshop. The deadline for preregistration is September 10, 2004. Information regarding the meeting and registration instructions are available on the Internet at http://www.aphis.usda.gov/brs/new_info.html. Questions that will be discussed during the workshop may be viewed on the Internet at http://www.aphis.usda.gov/brs/confine_workshop/confine_questions.pdf.

The third day of the workshop will be open to the public. Persons interested in making an oral presentation during the third day of the workshop related to the topic of the workshop should submit a brief written statement or abstract of the science they wish to present, the name and address of each person who will participate in the presentation, and an estimate of the approximate length of time needed to make the presentation. This information should be submitted to the person listed under FOR FURTHER INFORMATION CONTACT no later than September 6, 2004. The number of oral presentations on the third day of the workshop and the time allocated for each may be limited, depending upon the number of requests. Send all statements or abstracts to the person listed under FOR FURTHER INFORMATION CONTACT . Please state that your statement or abstract refers to Docket No. 04-074-1. If you use e-mail, your comment must be contained in the body of your message or sent as an attachment in WordPerfect or Microsoft Word format. Please include your name and address in your message and “Docket No. 04-074-1” on the subject line.

Following the workshop, a proceedings will be published that will summarize the information gathered during the workshop. The proceedings will outline methods for physical, temporal, spatial, and biological confinement of transgenes incorporated into wind-pollinated, insect-pollinated, and primarily self-pollinating crops along with information regarding their efficacy and feasibility of implementation. The effects of scale and use of models to predict or compare efficacy of options will also be addressed. Information gathered during the workshop will be summarized to illustrate the interaction of available tools for gene confinement to form a comprehensive and flexible approach to field testing. Scientific data and references will be included in a bibliography as part of the proceedings.

Please note that a fee of $2.25 is required to enter the parking lot at the USDA Center at Riverside. The machine accepts $1 bills or quarters.

Upon entering the building, visitors should inform security personnel that they are attending the Crop Field Testing workshop. Identification is required. Security personnel will direct visitors to the sign-in tables located outside of the Conference Center. All participants must sign in upon arrival. Conference badges must be worn throughout the day.

The business meeting September 9th begins at 9 a.m., at the Lassen National Forest Headquarters Office, Caribou Conference Room, 2550 Riverside Drive, Susanville, CA 96130. Agenda topics will include: Update on 2003 projects; Report of Pine Creek Project field trip; and Meeting Schedule Changes. Time will also be set aside for public comments at the beginning of the meeting.

Agenda topics include status of approved projects and receiving public comment. If the meeting date or location is changed, notice will be posted in the local newspapers, including the Daily Interlake based in Kalispell, MT.

The business meeting on September 17, at the Red Lion Conference Center, Lewiston, ID, begins at 10 a.m. (PST). Agenda topics will include discussion of potential projects. A public forum will begin at 2:30 p.m. (PST).

On March 1, 2004, the Department initiated and the Commission instituted a sunset review of the antidumping duty order on chloropicrin from the PRC, pursuant to section 751(c) of the Tariff Act of 1930, as amended, (“the Act”). 1 As a result of its review, the Department found that revocation of the antidumping duty order would be likely to lead to continuation or recurrence of dumping and notified the Commission of the magnitude of the margins likely to prevail were the order revoked. 2

On August 10, 2004, the Commission determined, pursuant to section 751(c) of the Act, that revocation of the antidumping duty order on chloropicrin from the PRC would be likely to lead to continuation or recurrence of material injury to an industry in the United States within a reasonably foreseeable time. 3

The merchandise subject to this antidumping duty order is chloropicrin, also known as trichloronitromethane. A major use of the product is as a pre-plant soil fumigant (pesticide). Such merchandise is currently classifiable under Harmonized Tariff Schedule (“HTS”) item number 2904.90.50. The HTS item number is provided for convenience and customs purposes. The written description remains dispositive.

As a result of the determinations by the Department and the Commission that revocation of this antidumping duty order would likely lead to continuation or recurrence of dumping and material injury to an industry in the United States, pursuant to section 751(d)(2) of the Act, the Department hereby orders the continuation of the antidumping duty order on chloropicrin from the PRC. The effective date of continuation of this order will be the date of publication in the Federal Register of this Notice of Continuation. Pursuant to sections 751(c)(2) and 751(c)(6) of the Act, the Department intends to initiate the next five-year review of this order not later than July 2009.

This action is authorized by the FMP and implementing regulations at 50 CFR 600.745.

The purpose of this exempted fishing activity would be to collect data on the rate at which unintended species, particularly overfished shelf rockfish such bocaccio and canary rockfish, are taken in commercial catches when an experimental flatfish-selective trawl net is used. If awarded, this EFP would allow six vessels to use the flatfish-selective trawl nets to fish for flatfish in the Trawl RCA south of 40°10′ N. latitude and to retain groundfish species in excess of cumulative trip limits. Participating vessels will be required to carry state-sponsored samplers to monitor fishing activities and collect data that are otherwise not available shoreside.

Shelf flatfish species are abundant and commercially important off California, however, the harvest of these species is constrained by efforts to rebuild overfished shelf rockfish species, particularly bocaccio and canary rockfish. In 2001 and 2002, the Oregon Department of Fish and Wildlife (ODFW) chartered commercial fishing vessels to develop and test flatfish-selective trawl nets. Testing was conducted to compare the new trawl net configurations with those that are typically used in the groundfish fishery. During the initial testing, a gear configuration similar to the design that is proposed for use under this EFP had significant reductions in the catch of overfished rockfish species relative to the catch of flatfish species. An EFP was issued to ODFW in 2003 to evaluate the performance of the experimental trawl net in the commercial flatfish fishery. This trawl net has since been referred to as “selective flatfish trawl gear.”

Because this gear design meets the requirements of small footrope bottom trawl gear, as defined by regulations at 50 CFR 660, it is currently legal to use for fishing and it could become an effective way for fishery participants to reduce rockfish bycatch in the flatfish fishery south of 40°10″ N. lat. Vessels participating under this EFP must submit a net plan and only gear that is consistent with the specified requirements may be used for EFP fishing. Fishing under this EFP will be restricted to areas outside of 3 nautical miles. The proposed EFP fishing period is from September 1 through December 31, 2004.

Data collected during this project are expected to benefit the management of the groundfish fishery by: (1) Providing catch rates by fishing location of species incidentally caught with the experimental flatfish-selective net, (2) allowing for the collection of biological data that is otherwise not available from landed catch, and (3) providing data that can be used to evaluate the full retention of rockfish as a management approach. The information gathered through this EFP may lead to future rulemaking.

The flatfish limits for limited entry trawl gear south of 40°10′ N. lat., as currently published in the Federal Register , will be available to EFP participants. Vessels used to fish under the EFP may fish for these limits within the Trawl RCA as well as in areas not within the Trawl RCA. If the limits are lowered later in the year through an inseason adjustment, the current limits will continue to be allowed under the EFP. The total amount (discard plus retained) of flatfish allowed to be taken under this EFP is not expected to exceed 653 metric tons (mt) and the total amount (discard plus retained) of petrale sole is not expected to exceed 109 mt. The EFP fishing will be constrained by the following EFP limits for overfished species: bocaccio rockfish, 10.0 mt; cowcod, 0.5 mt; yelloweye rockfish, 0.5 mt; canary 0.5 mt; lingcod, 20.0 mt. If the total catch of any one of these overfished species reaches the EFP limit, the EFP will be terminated for the remainder of the 2004 fishing year. All harvests are expected to be within set asides for 2004 EFP harvests and, therefore, no optimum yield is expected to be exceeded.

In accordance with regulations, NMFS determined that CDFG's proposal warranted further consideration and, therefore, consulted with the Council. The Council considered the EFP application during its April 2003 meeting and recommended that NMFS issue the EFP. Contingent on review of public comments, NMFS intends to approve the EFP fishing. A copy of the application is available for review from NMFS (see ADDRESSES ).

The Office of the Secretary of Defense notices for systems of records subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended, have been published in the Federal Register and are available from the address above.

The proposed systems reports, as required by 5 U.S.C. 552a(r) of the Privacy Act of 1974, as amended, were submitted on August 13, 2004, to the House Committee on Government Reform, the Senate Committee on Governmental Affairs, and the Office of Management and Budget (OMB) pursuant to paragraph 4c of Appendix I to OMB Circular No. A-130, “Federal Agency Responsibilities for Maintaining Records About Individuals,” dated February 8, 1996 (February 20, 1996, 61 FR 6427).

The Department of the Air Force's record system notices for records systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended, have been published in the Federal Register and are available from the address above.

The proposed system report, as required by 5 U.S.C. 552a(r) of the Privacy Act of 1974, as amended, was submitted on August 13, 2004, to the House Committee on Government Reform, the Senate Committee on Governmental Affairs, and the Office of Management and Budget (OMB) pursuant to paragraph 4c of Appendix I to OMB Circular No. A-130, ‘Federal Agency Responsibilities for Maintaining Records About Individuals,’ dated February 8, 1996 (February 20, 1996, 61 FR 6427).

The Department of the Army systems of records notices subject to the Privacy Act of 1974, (5 U.S.C. 552a), as amended, have been published in the Federal Register and are available from the address above.

The proposed system report, as required by 5 U.S.C. 552a(r) of the Privacy Act of 1974, as amended, was submitted on August 13, 2004, to the House Committee on Government Reform, the Senate Committee on Governmental Affairs, and the Office of Management and Budget (OMB) pursuant to paragraph 4c of Appendix I to OMB Circular No. A-130, “Federal Agency Responsibilities for Maintaining Records About Individuals,” dated February 8, 1996 (February 20, 1996, 61 FR 6427).

The Department of the Army systems of records notices to the Privacy Act of 1974, (5 U.S.C. 552a), as amended, have been published in the Federal Register and are available from the address above.

The proposed system report, as required by 5 U.S.C. 552a(r) of the Privacy Act of 1974, as amended, was submitted on August 13, 2004, to the House Committee on Government Reform, the Senate Committee on Governmental Affairs, and the Office of Management and Budget (OMB) pursuant to paragraph 4c of Appendix I to OMB Circular No. A-130, “Federal Agency Responsibilities for Maintaining Records About Individuals,” dated February 8, 1996 (February 20, 1996, 61 FR 6427).

The technical assistance workshops will be held as follows:

1. Atlanta, Georgia: Monday, September 27, 12:30-3:30 p.m. Hilton Garden Inn Atlanta Airport-Millenium Center, 2301 Sullivan Road, College Park, GA 30337. Phone: 404-766-0303.

2. St. Louis, Missouri: Wednesday, September 29, 12:30-3:30 p.m. Renaissance St. Louis Airport Hotel, 9801 Natural Bridge Road, St. Louis, MO 63134. Phone: 314-429-1100.

3. Los Angeles, California: Thursday, September 30, 12:30-3:30 p.m. Westin Los Angeles Airport Hotel, 5400 West Century Boulevard, Los Angeles, CA 90045. Phone: 310-216-5858.

4. Washington, DC: Tuesday, October 5, 10 a.m. -1 p.m. with optional writing clinic 2-4 p.m. Barnard Auditorium, Education Department, 400 Maryland Avenue, SW., Washington, DC 20202.

Space at the workshops is limited. Interested individuals are invited to register at this site: http://www.ed.gov/FIPSE.

Please indicate the location you are requesting. You will receive an e-mail reply confirming the status of your registration along with exact information on workshop locations. All confirmed registrants are asked to bring their printed e-mail confirmation to the workshop.

The technical assistance workshop sites are accessible to individuals with disabilities. If you will need an auxiliary aid or service to participate in the workshop ( e.g., interpreting service, assistive listening device, or materials in an alternative format) notify the contact person listed under FOR FURTHER INFORMATION CONTACT at least two weeks before the scheduled workshop date. Although we will attempt to meet a request received after this date, we may not be able to make available the requested auxiliary aid or service because of insufficient time to arrange it.

You may view this document, as well as all other documents of this Department published in the Federal Register, in text or Adobe Portable Document Format (PDF) on the Internet at the following site: http://www.ed.gov/news/fedregister.

To use PDF you must have Adobe Acrobat Reader, which is available free at the site. If you have questions about using PDF, call the U.S. Government Printing Office (GPO), toll free at 1-888-293-6498, or in the Washington, DC area at (202) 512-1530.

The Energy Employees Occupational Illness Compensation Program Act of 2000 (“Act”), Title 36 of Public Law 106-398, establishes a program to provide compensation to individuals who developed illnesses as a result of their employment in nuclear weapons production-related activities and at certain federally owned facilities in which radioactive materials were used. On December 7, 2000, the President issued Executive Order 13179 (“Order”) directing the Department of Energy (“Department” or “DOE”) to list covered facilities in the Federal Register . This notice revises the previous lists and provides additional information about the covered facilities, atomic weapons employers, and beryllium vendors.

Section 2.c.iv of the Order instructs the Department to designate, pursuant to sections 3621(4)(B) and 3622 of the Act, atomic weapons employers (AWE's). In addition, Section 2.c.vii of the Order instructs the Department to list three types of facilities defined in the Act:

(1) Atomic weapons employer facilities, as defined in section 3621(4);

(2) Department of Energy facilities, as defined by section 3621(12); and

(3) Beryllium vendors, as defined by section 3621(6).

Compensation options and mechanisms are defined differently for each of these facility categories. The atomic weapons employer category includes atomic weapons employer facilities in which the primary work was not related to atomic weapons, and consequently these facilities are not commonly known as atomic weapons facilities. Their inclusion in this list is consistent with the Act, and is not intended as a classification for any other purpose.

The list at the end of this notice represents the Department's best efforts to date to compile a list of facilities under these three categories. This listing includes 363 facilities in 46 jurisdictions. Today's publication of the list newly designates General Electric's X-ray Division in Milwaukee, WI as an AWE, and additionally designates the Nevada Site Office as a DOE facility. It also alters slightly the designation for Blockson Chemical (broadens it by saying “building 55 and related activities” which is meant to include the AEC-funded laboratory, pilot plant and oxidation process). Other corrections include: B&T Metals (OH) (the DOE designation was in error and has been removed), Foote Mineral (PA) (the BE designation has been on the program's Web site (noted below) since inception, but was inadvertently missing from the Federal Register notice), Swenson Evaporator (is located in Harvey, not Chicago, IL) and C.H. Schnorr, PA (previously Schnoor). This notice also deletes the listing for Ledoux (NY) entirely because it was learned that no radioactivity was used at that location.

In addition to continuing its research efforts, the Department has developed information dissemination mechanisms to make facility-specific data available to the public. Information about each listed facility, including the dates and type of work done there, is available by contacting the Office of Worker Advocacy. These descriptions are available in print form and also electronically (via the World Wide Web at http://tis.eh.doe.gov/advocacy/ ).

The list that follows covers facilities under the three categories of employers defined by the Act: atomic weapons employers (“AWE”), Department of Energy facilities (“DOE”), and beryllium vendors (“BE”). Each of the categories has been defined in the original notice and include:

The lines between research, atomic weapons production, and non-weapons production are often difficult to draw. For the purposes of this notice, and as directed by the Act, only those facilities whose work involved radioactive material that was connected to the atomic weapons production chain are included. This includes facilities that received radioactive material that had been used in the production of an atomic weapon, or the “back end” of the production cycle, such as waste handling or reprocessing operations. For the purposes of this listing, the Department considers commercial nuclear fuel fabrication facilities to be covered facilities for those periods when they either supplied radioactive materials to the Department or received radioactive materials that had been used in the Department's production reactors.

Corporate information regarding many of the listed facilities is often not readily available. The Department welcomes comments or additional information regarding facilities that may have supported atomic weapons production that are not on this list, as well as information that clarifies the work done at facilities named below.

The listing of Department of Energy facilities is only intended for the context of implementing this Act and does not create or imply any new Departmental obligations or ownership at any of the facilities named on this list.

Section 3621(6) of the Act defines beryllium vendor as the following:

“(A) Atomics International.

(B) Brush Wellman, Incorporated, and its predecessor, Brush Beryllium Company.

(C) General Atomics.

(D) General Electric Company.

(E) NGK Metals Corporation and its predecessors, Kawecki-Berylco, Cabot Corporation, BerylCo, and Beryllium Corporation of America.

(F) Nuclear Materials and Equipment Corporation.

(G) StarMet Corporation, and its predecessor, Nuclear Metals, Incorporated.

(H) Wyman Gordan, Incorporated.

(I) Any other vendor, processor, or producer of beryllium or related products designated as a beryllium vendor for purposes of this title under Section 3622.”

The list identifies facilities that processed, produced, or provided beryllium metal for the Department, as defined by the Act.

Purpose of the Board: The purpose of the Advisory Board is to make recommendations to DOE in the areas of environmental restoration, waste management, and related activities.

Tentative Agenda:

Copies of the final agenda will be available at the meeting.

Public Participation: The meeting is open to the public. Written statements may be filed with the Committee either before or after the meeting. Individuals who wish to make oral statements pertaining to agenda items should contact Kelly Kozeliski, at the telephone number listed above. Requests must be received 5 days prior to the meeting and reasonable provision will be made to include the presentation in the agenda. The Deputy Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Each individual wishing to make public comment will be provided a maximum of five minutes to present their comments.

Minutes: The minutes of this meeting will be available for public review and copying at the Freedom of Information Public Reading Room, 1E-190, Forrestal Building, 1000 Independence Avenue, SW., Washington, DC 20585 between 9 a.m. and 4 p.m., Monday-Friday, except Federal holidays. Minutes will also be available by writing to Kay Planamento at the address listed above.

EPA has established a public docket for this ICR under Docket ID number OAR-2004-0228, which is available for public viewing at the Air and Radiation Docket in the EPA Docket Center (EPA/DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is (202) 566-1744, and the telephone number for the Air and Radiation Docket is (202) 566-1742. An electronic version of the public docket is available through EPA Dockets (EDOCKET) at http://www.epa.gov/edocket. Use EDOCKET to obtain a copy of the draft collection of information, submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select “search,” then key in the docket ID number identified above.

Any comments related to this ICR should be submitted to EPA within 60 days of this notice. EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. For further information about the electronic docket, see EPA's Federal Register notice describing the electronic docket at 67 FR 38102 (May 31, 2002), or go to http://www.epa.gov./edocket.

Affected entities: Entities potentially affected by this action are those which produce semiconductor devices in the United States.

Title: Reporting and Recordkeeping Activities Associated With EPA's PFC Reduction/Climate Partnership for the Semiconductor Industry.

Abstract: The U.S. EPA's Office of Atmospheric Programs launched the PFC Reduction/Climate Partnership for the Semiconductor Industry in 1996. Perfluorinated compounds (PFCs) are the most potent greenhouse gases known with atmospheric lifetimes of up to 50,000 years. These unique chemical compounds are required during two critical semiconductor manufacturing steps, plasma etching and CVD chamber cleaning. This important voluntary program contributes to the country's overall reduction in greenhouse gas emissions. The program uses a pollution prevention approach to reduce emissions and tracks progress by annually collecting PFC emissions estimates from partners.

EPA's semiconductor industry partners share information on technically feasible emission reduction strategies and EPA recognizes companies for their success in reducing PFC emissions through certificates, awards, and assistance in communicating their achievements with the public. In 2003, EPA's semiconductor industry partners were recognized for their commitment and ongoing efforts to protect the climate as participants in the White House's Climate VISION initiative. All semiconductor manufacturers operating in the U.S. are invited to join the partnership. Participation in the program begins by completing a Memorandum of Understanding that defines a voluntary agreement between the company and EPA. By joining the partnership, a company agrees to track and report an estimate of its PFC emissions to EPA annually. A designated third party assembles the reported data and protects any confidential or sensitive information prior to EPA review. The partner companies' annual reports will provide an estimate of total PFC emissions and a description of the estimating method. The partnership will track progress as a group using the aggregate annual PFC emissions estimate.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.

The EPA would like to solicit comments to:

(i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;

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

(iii) Enhance the quality, utility, and clarity of the information to be collected; and

(iv) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g. , permitting electronic submission of responses.

Burden Statement: In estimating the expected burden, EPA assumes 21 companies will participate during the three years covered by this proposed ICR.

Average annual reporting burden hours =11,426.

Average burden hours/response =247.

Frequency of response =1/year.

Estimated number of respondents =21.

Estimated total annual cost burden =$839,464.

Total capital and start-up costs =$0.

Total operation and maintenance costs =$116,319.

Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

The following listing provides certain key information concerning the funding opportunity.

•  Federal agency name : Environmental Protection Agency (EPA).

•  Funding opportunity title : National Pesticide Information Center (NPIC) & National Pesticide Medical Monitoring Program (NPMMP).

•  Announcement type : The initial announcement of a funding opportunity.

•  Catalog of Federal Domestic Assistance (CFDA) number : Research Grants No. 66.500.

This action may be of particular interest to universities and colleges who have experience and expertise in pesticide toxicology; environmental chemistry; environmental fate; human and animal medical diagnostic and crisis management assistance; workings with health care providers; quantitative analyses of environmental and biological samples pertaining to pesticides; pesticide poisonings; integrated pest management (IPM); information technology and information management (IT/IM); telecommunication networks; outreach and marketing; and the Federal statutes involved within the Office of Pesticide Programs (OPP), e.g., Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), Federal Food, Drug, and Cosmetic Act (FFDCA), and Food Quality Protection Act (FQPA). Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be interested by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

1. Docket . EPA has established an official public docket for this action under docket identification (ID) number OPP-2004-0098. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1801 S. Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

2. Electronic access . You may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/ . An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit II.B.1. Once in the system, select “search,” then key in the appropriate docket ID number.

Since the 1980's OPP has provided funding for the National Pesticide Information Center (NPIC) formerly called the National Pesticide Telecommunications Network (NPTN).

FIFRA, as amended, authorizes EPA to monitor incidental exposure to man, animals and the environment, and to identify pesticide pollution, secular trends (continuing trends) and sources of contamination and their relationship to human and environmental effects. FIFRA also calls for a National Monitoring Plan; a national plan for monitoring pesticides in cooperation with other Federal, state or local agencies.

Since the inception of EPA, the Agency has attempted in many ways to conduct specific monitoring projects. NPIC is a part of that effort and is included in the National Monitoring Plan. The idea of a toll free telephone service was initiated in 1978 for exclusive use by health professionals in the recognition and management of pesticide poisonings. Later the telephone service was extended to include the general public and expanded to provide a variety of other pesticide information. Over the years, the number of telephone calls handled has fluctuated annually from about 2,000 to a high of 53,598 in 1990, whereas in the last couple years the annual calls taken range from 23,000-24,500. In the last several years, inquiries have been received from all states plus Puerto Rico, the Virgin Islands, Canada, Mexico, Argentina, Germany, and numerous other foreign countries. Calls are received from hundreds of organizations; however, the general public constitutes the largest percent calling group, generally ranging from 84% to 88% annually.

The peak call load periods are from April through September each year. However, the NPIC has experienced numerous peaks developed from external causes; whereby, adjustments had to be made to adequately handle the workload, e.g. rebalancing staffing.

The NPIC telephone number has been promoted through family and women's magazines, EPA publications, TV and radio public announcements, general news media, and word of mouth. Additionally, attendance of NPIC personnel at professional meetings, e.g., American Academy of Occupational Medicine, National Professional Lawn Care Association, American College of Emergency Physicians, and Annual Pest Control Operators, has increased the visibility of NPIC services. NPIC also devotes considerable resources to its wide range outreach program and is continually addressing under served audiences.

With the formation of an EPA NPIC Oversight and Monitoring Committee (OMC) in the early 1990's and meetings presently continuing, helps information sources used by NPIC to remain accurate, current, and impartial. NPIC operates 10 hours a day, 6:30 a.m. to 4:30 p.m., Monday through Sunday, providing toll free telephone service in the United States, Puerto Rico, and the Virgin Islands. NPIC maintains a library of up-to-date information on a wide variety of pesticide subjects, providing the caller with:

• Pesticide product information.

• Information on recognition and management of pesticide poisonings.

• Toxicology and symptomatic reviews.

• Environmental chemistry.

• Referrals for laboratory analyses, investigation of pesticide incidents, and emergency treatment information.

• Safety information.

• Health and environmental effects.

• Clean-up and disposal procedures.

In emergency situations where additional expertise is needed, human and animal poisonings are referred via a telephone switching system to either the Oregon Poison Center or the National Animal Poison Control Center. Both organizations, being under retainer to NPIC, provide extensive experience in handling pesticide poisonings.

NPIC has continually evolved to better serve its users. It currently provides its callers information in real time by furnishing requested information via the telephone, through e-mail, and fax. Individuals can report pesticide incidents toll free, acquire extensive pesticide-related information via their Web site, and receive current periodic EPA information. Also, OPP can refer a variety of calls received directly to NPIC for reply. NPIC acts as a “sounding board” from the general public as to their awareness and concerns about pesticides.

In addition, the NPIC provides information assistance directly to the OPP's Pesticide Incident Response Officer (PIRO) in order to promote an on-going rapid response to unanticipated, major incidents which may require immediate evaluation and action in emergency situations to persons suspected of being adversely exposed to pesticides. The NPIC possesses expertise to provide highly skilled consultants, diagnostic treatment, and laboratory assistance to the general public via the PIRO.

Since the 1980's OPP has provided funding for the National Pesticide Medical Monitoring Program (NPMMP).

FIFRA, as amended, authorizes EPA to monitor incidental exposure to man, animals and the environment, and to identify pesticide pollution, secular trends and sources of contamination and their relationship to human and environmental effects. FIFRA also calls for a National Monitoring Plan; a national plan for monitoring pesticides in cooperation with other Federal, state or local agencies.

Since the inception of EPA, the Agency has attempted in many ways to conduct specific monitoring projects. NPMMP is a part of that effort and is included in the National Monitoring Plan.

In the past 10 years, the NPMMP has received nearly 6,000 referrals from a variety of sources including: State public health departments, health care providers, government agencies, the general public, as well as NPIC. NPMMP is an invaluable resource for many organizations that need to refer inquiries of a complex medical nature to an expert in the field. It is not unusual for an individual to have contacted numerous agencies in search for assistance relating to a suspected pesticide exposure. Callers referred to NPMMP are frequently frustrated or confused, given some of the uncertainties with respect to pesticide exposures, as well as the vast amount of information (sometimes conflicting) that is available to the general public. NPMMP presents an empathetic yet science-based approach to responding to these inquiries. The project offers field investigations, medical toxicological consultations, and laboratory analyses of both biological and environmental samples.

The NPMMP is recognized by many state agencies and health care providers as a national “one of a kind” reliable source for medical consultation for individuals exposed to pesticides. The availability of a laboratory that can analyze various biological samples, i.e., human blood and urine and environment also adds to the uniqueness of the project.

To continue the NPIC and the NPMMP projects, EPA is soliciting applications from universities and colleges with expertise and working knowledge in the following areas:

1. NPIC . Pesticide toxicology; environmental chemistry; environmental fate; human and animal medical diagnostic and crisis management assistance; emergency medicine; integrated pest management (IPM); extension service; risk communication; conventional pesticides including antimicrobials and products of biotechnology; communication skills with the public; IT/IM; telecommunication networks; outreach and marketing; and the Federal statutes involved within the Office of Pesticide Programs (OPP), e.g., FIFRA, FFDCA, and FQPA.

2. NPMMP . Emergency medicine; pesticide clinical toxicology; environmental chemistry; environmental fate; human and animal medical diagnostic and crisis management assistance; risk communication; workings with health care providers; conventional pesticides including antimicrobials and products of biotechnology; quantitative analyses of environmental and biological samples pertaining to pesticides; pesticide poisonings; extension service; IPM; IT/IM; telecommunication networks; outreach and marketing; and the Federal statutes involved within OPP, e.g., FIFRA, FFDCA, and FQPA.

This document outlines the application requirements and procedures for the NPIC and the NPMMP projects.

1. NPIC . It is well established that the public has difficulty in obtaining accurate, unbiased pesticide information and NPIC fills that void. The mere numbers of telephone calls received yearly (23,000-25,000) by NPIC and over 780,000 hits on its World Wide Web site clearly illustrates the interest the public has concerning pesticide issues. The financial assistance provided under this project will support the delivery to the public of objective, science-based information, on a wide variety of pesticide-related subjects, in real time. In part, on-line pesticide specialist should be capable of providing information in a user-friendly manner and be adept at communicating scientific information to the lay person which in turn promotes informed decision-making on the part of the caller. NPIC is a direct service to the public.

It is also well noted that most health care providers are not well acquainted with the recognition, management, and prevention of health effects from pesticide exposures. Unique to NPIC is that one of the toxicologists is also a physician trained in clinical toxicology and emergency medicine and board certified in the specialties of Public Health and General Preventive Medicine. With a strong background in pesticide toxicology, this physician adds additional depth to the NPIC project in being able to communicate not only with state public health departments and health care providers but also with the general public.

The most tangible and direct interface between NPIC and its clientele is the telephone. This is via a toll-free telephone system. NPIC should provide quality user-friendly service to callers. NPIC must have well qualified pesticide specialists, with the technical expertise to address a variety of types of inquiries ranging from simple to very complex and often controversial. In addition to delivery of information by a toll-free telephone system, fax, mail, and e-mail, the Internet must be made available. Current and accurate information on a wide variety of pesticide subjects must be readily available to the public. This project must be on the cutting edge of, IT/IM, extremely knowledgeable in the world of pesticides, promote an aggressive marketing and outreach program with emphasis on the under-served populations, and sustain excellent customer service.

NPIC must strive to integrate the values of professionalism, teamwork, integrity, accountability, and a strong commitment to the public, as well as, the professional and medical communities, in order to help fulfill their mission and provide exceptional and respectful customer service. Part of this is best accomplished by funding in the form of a cooperative agreement. This allows the university the flexibility to quickly react to new needs for pesticide-related information as initiated by pesticide incidents; new regulations; public interests; IT/IM technology; and specific needs by either the project or EPA. Further, this flexibility encourages involvement of and makes available to NPIC and thus to the public, the full capabilities of the university community with respect to access to: Pesticide specialists from a number of disciplines, e.g., IPM experts, biotechnology, and entomology. In addition, the specialist have opportunities to advance their education through on the job-training; advanced classroom work; exposure at national meetings and symposiums; and numerous interactions with many individuals in OPP. A cooperative agreement at a university setting allows creative thinking and scholarship.

The continual success of NPIC will promote a better understanding into the world of pesticides for all communities (general public, professional, and medical) and help reduce pesticide poisonings. These programs are included in the Catalog of Federal Domestic Assistance under number 66.500 at http://www.cfda.gov/public/whole.pdf .

2. NPMMP . It is widely known that a high percent of the health care providers in the United States are not properly prepared to identify, diagnose, treat, or provide advice to individuals suspected of pesticide exposure. It is also evident that the general public finds it difficult to locate a physician that fully understands pesticide exposure scenarios and who is also capable of discussing the many issues that may be involved and relating this information in a way that is understandable to the lay person. The financial assistance provided under this project will support the delivery to the general public, health care providers, and government agencies information pertaining to both the clinical and basic toxicology of pesticides. NPMMP will provide immediate information and assistance to health care providers, regulatory officials, and other agencies involved in the investigation and management of suspected human illnesses associated with pesticide exposures. The information provided will benefit inquiries by providing unique expertise in pesticide toxicology, and informational assistance relating to the recognition, management, and prevention of pesticide exposures. Thus, this project provides information in real time on suspected pesticide-related illness in both acute and chronic scenarios. Information provided benefits inquiries by answering questions as well as, in some cases, providing assistance in the investigation of suspected illnesses or in an ancillary role in the treatment of acute or chronic disease. NPMMP communicates to the public on a variety of issues relating to pesticides, and directs individuals towards appropriate resources in cases where additional assistance is needed. This assistance is provided by a physician through his/her professional knowledge and experience, and from the added ability of utilizing a laboratory that is capable of analyzing environmental samples and biological (human blood and urine). This physician is trained in clinical toxicology and emergency medicine and board certified in the specialties of Public Health and General Preventive Medicine.

NPMMP provides medical histories and environmental analysis of suspected pesticide illnesses that relate to the current use of pesticides in structural, agricultural, or other environmental situations. It brings attention to the possibility of human illnesses which may not have been suspected by basic toxicology screens but which may exist and require more extensive clinical or basic scientific testing. Some scenarios may relate to specific formulations or based upon the nature of the inquiries received, may indicate that there are problems existing with the exact active ingredients used regardless of formulation. NPMMP will also bring attention to potential cases of illness which may not have been suspected or identified through the regulatory review process for pesticides, as well as cases developing through the misapplication of pesticides.

The NPMMP library of pesticide information that has been assembled by current and previous investigators is being expanded to incorporate new publications from the scientific literature, as well as regulatory decisions relating to pesticides. The library is being electronically scanned in order to enable investigators to have immediate access to important documents, and to facilitate the electronic transfer of information to inquirers in situations where such information is requested or immediately necessary.

Information must be collected from all callers with inquiries to the NPMMP. Data should include basic demographic information, the circumstances surrounding the exposure incident or informational inquiry, the pesticide that is the subject of inquiry, and a certainty and severity index rating. No direct patient care should be provided, since this project is information in nature. However in some cases, medical records may be provided to the investigators in the process of responding to inquiries. The NPMMP investigators must complete training for the implementation of the Health Insurance Portability and Accounting Act (HIPAA). The protocol for the NPMMP should undergo review and approval by the Institutional Review Board of the university or college selected.

The continual success of NPMMP provides immediate assistance to both the general public and health care providers involved in pesticide incidents/exposures. This project brings attention to potential cases of illness which may not have been suspected or identified through the regulatory review process for pesticides, as well as cases developed through the misapplication of pesticides. These programs are included in the Catalog of Federal Domestic Assistance under number 66.500 at http://www.cfda.gov/public/whole.pdf .

Through the proposals sought under these projects, EPA intends to work with universities and colleges to develop or continue the NPIC and the NPMMP.

1. NPIC . NPIC is to serve as a source of objective, science-based information, on a wide variety of pesticide-related subjects, in real time. These subjects include: Pesticide products; recognition and management of pesticide poisonings; toxicology; environmental chemistry; safety practices; health and environmental effects; clean-up and disposal; emergency treatment for humans and animals; pesticide regulations and corresponding Federal statutes; and laboratory analyses and pesticide incident investigation assistance.

The objectives of NPIC are to develop or continue to:

• Operate a toll-free telephone service providing a variety of accurate, impartial pesticide information to callers in the United States, Puerto Rico, and the Virgin Islands, in real time. The project will operate Monday through Sunday, 10 hours daily. A recording device will be provided to capture off-hour calls.

• Provide access to NPIC and pesticide-related information through a state of the art World Wide Web site and e-mail.

• Serve as a source of factual unbiased information on pesticide chemistry, toxicology, and environmental fate to all inquiries, including industry, government, medical, agricultural sector, news media, as well as the general public.

• Provide the medical community with diagnostic and crisis management assistance involving pesticide incidents in situations pertaining to both human and animal patients.

• Acquire accurate and complete information on all inquiries considered to be pesticide incidents.

• Computerize all inquiry information as well as pesticide incident data for easy retrieval.

2. NPMMP . NPMMP provides a rapid response in the form of skilled technical assistance to persons suspected of being adversely affected by pesticide exposures. The project will consist of field investigations, medical toxicological consultations, and laboratory analyses of both biological and environmental samples.

The objectives of the NPMMP are to develop or continue to:

• Make information pertaining to both the clinical and basic toxicology of pesticides available to all inquiries from the United States.

• Provide written information on pesticide toxicology, when available and requested, to respond to inquiries.

• Provide quantitative laboratory measurements of pesticides in environmental samples, as well as in select cases, in biological samples of exposed human beings.

• Define inquiries and incidents relating to human pesticide exposures.

• Develop and maintain computer access to toxicology databases including Toxline (National Library of Medicine), Poisindex (Micromedex), SciFinder Scholar, etc.

• Expand the library of basic and clinical toxicology journals, reports of industry and government, textbooks, and other paper and electronic resources pertaining to pesticides and their impact on human health.

1. Applicants . Grant funds are available to universities and colleges who have experience and expertise in pesticide toxicology; environmental chemistry; environmental fate; human and animal medical diagnostic and crisis management assistance; extension service; pesticide poisonings; emergency medicine; quantitative analyses of environmental and biological samples; conventional pesticides including antimicrobials and products of biotechnology; IPM; IT/IM; telecommunication networks; outreach and marketing; and the Federal statutes involved within OPP, e.g., FIFRA, FFDCA, and FQPA.

To be eligible for consideration, applicants must meet all of the following criteria. Failure to meet the following criteria will result in the automatic disqualification for consideration of the proposal for funding:

• Be an applicant who is eligible to receive funding under this announcement.

• The proposal must address all of the high priority areas for consideration.

• The proposal must meet all format and content requirements contained in this notice.

• The proposal must comply with the directions for submittal contained in this notice.

There is a 5% cost share requirement for these projects.

2. Qualifications . Applicants must demonstrate experience and expertise in the following high priority areas for consideration to serve as the source that is to provide objective science-based information, on a wide variety of pesticide-related subjects, in real-time and to fulfill the objectives of this program. Applicants will be evaluated on the following criteria:

a. Academic experience requirements :

• A university containing one or more of the following: School of Medicine; School of Public Health; School of Veterinary Medicine; and/or College of Allied Sciences.

• Documented experience and expertise in four or more of the following disciplines: Epidemiology; occupational health; industrial hygiene; environmental health; agricultural health; pesticide toxicology; animal toxicology; risk assessment; and health education.

• Documented experience and expertise in three or more of the following: Environmental biology; agricultural ecology; fish/wildlife biology; agronomy; horticulture; environmental chemistry; extension service; IPM; genetic engineering; gene research; water quality; and food safety.

• Documented experience and expertise in survey design and bio-statistics.

• Documented experience and expertise in marketing; outreach; communications; and IT/IM.

• Documented experience and expertise in basic toxicology; clinical toxicology; and clinical laboratory analyses.

• Knowledge of the Pesticide Registration Improvement Act, specifically section 33(c)(B), Worker Protection.

b. Technical experience requirements :

• Documented experience of the proposed staff to establish and maintain a large-scale telecommunications network, including telephone, fax, e-mail, and Web site.

• Demonstrated expertise and experience with creation of an up-to-date, modern Web site for posting and delivery of NPIC information and for links to objective or otherwise relevant pesticide information on the World Wide Web.

• Demonstrated expertise and experience in the establishment of an information management retrieval system which can be used to “mine” objective pesticide-related information from selected sites on the World Wide Web and/or hard copy resources. The information should be indexed and made searchable and selectively retrievable by the general public through a user-friendly web browser-based interface.

• Documented experience and expertise in the creation and management of a computer system, including a computer network, with workstations for pesticide specialists and a UNIX server for housing the NPIC web site, information base (repository of electronic pesticide information), and related software (e.g., Apache Web server, Oracle data base) capable of supporting the needs of NPIC. Also, including the implementation and management of a firewall to provide a high-level of security for NPIC computers, data, and information.

• Broad, multidisciplinary experience in knowledge of pesticide, uses, formulations, toxicity, health and environmental effects, and disposal and considerable experience and knowledge in the Federal statutes, e.g., FIFRA, FFDCA, and FQPA, involving OPP, including risk assessment, water quality, food safety, and OPP's entire regulatory process.

• Demonstrated experience and expertise with all pesticides (including antimicrobials and biopesticides), pesticide-related issues and pesticide regulations.

• Experience with the medical community, health care providers, poison control centers and others including all levels of government that are involved in the diagnostic and crisis management concerning human and domestic animal poisonings.

c. Staffing requirements :

• The university/college will consist of a project director; co-principal investigators; a project coordinator; and core staff.

• The university/college must have a physician with extensive knowledge in medical/clinical toxicology and pesticides. This individual must be able to demonstrate the ability to handle pesticide cases of clinical importance or unexpected outcome and also be able to interpret human health information in the context of the regulatory risk assessment process. This physician must be well-versed in the major federal/state statutes governing the use of pesticides in the United States. Also, it is strongly preferred this physician be physically located on the same campus as NPIC.

• The university/college must have the ability to adequately handle spanish speaking inquiries; therefore, they must demonstrate an ability to present and provide all pertinent pesticide information in spanish.

ii. National Pesticide Medical Monitoring Program (NPMMP) :

a. Academic experience requirements :

• A university containing one or more of the following: School of Medicine; School of Public Health; School of Veterinary Medicine; and/or College of Allied Sciences.

• Documented experience and expertise in four or more of the following disciplines: Epidemiology; occupational health; emergency medicine; industrial hygiene; environmental health; agricultural health; pesticide toxicology; animal toxicology; risk assessment; and health education.

• Documented experience and expertise in three or more of the following: Environmental biology; agricultural ecology; agronomy; horticulture; environmental chemistry; extension service; IPM; genetic engineering; gene research; water quality; and food safety.

• Documented experience and expertise in survey design and bio-statistics.

• Documented experience and expertise in marketing; outreach; communications; and IT/IM.

• Documented experience and expertise in basic toxicology; clinical toxicology; and clinical laboratory analyses.

b. Technical experience requirements :

• Broad, multidisciplinary experience in knowledge of pesticide, uses, formulations, toxicity, health and environmental effects, and disposal and considerable experience and knowledge in the Federal statutes, e.g., FIFRA, FFDCA, FQPA, involving OPP, including risk assessment, water quality, food safety, and OPP's entire regulatory process.

• Demonstrated experience and expertise with all pesticides(including antimicrobials and biopesticides), pesticide-related issues and pesticide regulations.

• Experience with the medical community, health care providers, poison control centers and others including all levels of government that are involved in the diagnostic and crisis management concerning human and domestic animal pesticide poisonings.

• Has published on the topic of pesticide poisonings and other pesticide-related issues.

• Experience with the migrant worker health problems, especially as it relates to pesticides, as well as, other under served occupational populations.

c. Staffing requirements :

• The university/college will consist of a principal investigator and appropriate staff.

• The university/college must have a physician with extensive knowledge in medical/clinical toxicology and pesticides. This individual must be able to demonstrate the ability to handle pesticide cases of clinical importance or unexpected outcome and also be able to interpret human health information in the context of the regulatory risk assessment process. This physician must be well-versed in the major federal/state statutes governing the use of pesticides in the United States. Also, it is strongly preferred this physician be physically located on the same campus as NPIC and have a working knowledge of the overall mission and objectives of NPIC.

EPA expects to enter into cooperative agreements under the authority provided in FIFRA section 20 which authorizes the Agency to issue grants or cooperative agreements for research, public education, training, monitoring, demonstration, and studies. Regulations governing these cooperative agreements are found at 40 CFR part 30 for institutions of higher education, colleges and universities, and non-profit organizations; and 40 CFR part 31 for states and local governments. In addition, the provisions in 40 CFR part 32, governing government wide debarment and suspension; and the provisions in 40 CFR part 40, regarding restrictions on lobbying apply. All costs incurred under this program must be allowable under the applicable OMB Cost Circulars: A-87 (states and local governments), A-122 (nonprofit organizations), or A-21 (universities). Copies of these circulars can be found at http://www.whitehouse.gov/omb/circulars/ . In accordance with EPA policy and the OMB circulars, as appropriate, any recipient of funding must agree not to use assistance funds for lobbying, fund-raising, or political activities (e.g., lobbying members of Congress or lobbying for other Federal grants, cooperative agreements, or contracts). See 40 CFR part 40.

The cooperative agreements will fund activities that fulfill the objectives of the NPIC and NPMMP.

1. NPIC . The objectives of the NPIC are as follows:

• To operate a toll-free telephone service providing a variety of accurate, impartial pesticide information to callers in the United States, Puerto Rico, and the Virgin Islands, in real time. The project will operate Monday through Sunday, 10 hours daily. A recording device will be provided to capture off-hour calls.

• To provide access to NPIC and pesticide-related information through a state of the art World Wide Web site and e-mail.

• To serve as a source of factual unbiased information on pesticide chemistry, toxicology, and environmental fate to all inquiries, including industry, government, medical, agricultural sector, news media, as well as the general public.

• To provide the medical community with diagnostic and crisis management assistance involving pesticide incidents in situations pertaining to both human and animal patients.

• To acquire accurate and complete information on all inquiries considered to be pesticide incidents.

• To computerize all inquiry information as well as pesticide incident data for easy retrieval.

2. NPMMP . The objectives of the NPMMP are as follows:

• To make information pertaining to both the clinical and basic toxicology of pesticides available to all inquiries from the United States.

• To provide written information on pesticide toxicology, when available and requested, to respond to inquiries.

• To provide quantitative laboratory measurements of pesticides in environmental samples, as well as in select cases, in biological samples of exposed human beings.

• To define inquiries and incidents relating to human pesticide exposures.

• To develop and maintain computer access to toxicology databases including Toxline (National Library of Medicine), Poisindex (Micromedex), SciFinder Scholar, etc.

• To expand the library of basic and clinical toxicology journals, reports of industry and government, textbooks, and other paper and electronic resources pertaining to pesticides and their impact on human health.

1. NPIC . The technical proposal should fully describe an approach to fulfilling the objectives of NPIC. It should include but not be limited to:

• Administrative and operational infrastructure that will support NPIC' s goal and objectives.

• The establishment of quality assurance/quality control procedures for, training of pesticide specialists; information materials created and distributed by NPIC; information collected on all calls; and information acquired for use in answering inquiries from the public.

• Training of specialists in all areas of pesticide information, regulations, pesticide toxicology, risk assessment, etc., and especially relating this information to the public.

• Total estimated budget by cost category, e g., personnel, travel, equipment, supplies, contractual services, and most important—indirect rate and costs.

• Other management techniques and procedures necessary to ensure the quality and timeliness of all objectives.

• A complete description of the qualifications of each selected NPIC staff member.

Prepare a description of the optimal approach to each task, including a working definition of anticipated problems, a description of specific features of the approach to the task, specific staff personnel involved, timing and logistical considerations, estimated resource requirements, and expected work products. Avoid generalized statements, e.g., following established procedures.

•  Task 1 : Develop a plan to handle calls/inquiries from the general public and medical community involving pesticide incidents, e.g., alleged pesticide-related health concerns, pesticide exposures, whereby expertise in medicine and pesticide toxicology is required. Include all benefits realized by NPIC.

•  Task 2 : Develop a written and schematic plan that illustrates a comprehensive computer infrastructure and state of the art World Wide Web site that will adequately meet the requirements of NPIC presently and in the future.

•  Task 3 . Develop a plan to respond to the activities funded by the Pesticide Registration Improvement Act, (Section 33(c)(3)(B)), Worker Protection, that will enhance current scientific and regulatory activities related to worker protection. This plan should include, but not be limited to staffed positions that:

-- Respond to calls received from around the country during the agricultural work day, as well as during evening and weekend hours.

-- Have the ability to respond to calls in English and in Spanish.

-- Have access to translation services to handle calls in Haitian, Creole, and Asian languages.

-- Have the ability to make referrals to relevant health services, when appropriate.

-- Have the ability to make referrals to state enforcement agencies, when appropriate.

-- Have the ability to aggregate call and referral information/data into reports which may be distributed to various organizations involved in the overall Worker Protection effort.

2. NPMMP . The technical proposal should fully describe an approach to fulfilling the objectives of NPMMP. It should include but not be limited to:

• Administrative and operational infrastructure that will support NPMMP's goal and objectives.

• The establishment of quality assurance/quality control procedures for information materials created and distributed by NPMMP; information collected on all calls; and information acquired for use in answering inquiries from the public.

• Total estimated budget by cost category, e g., personnel, travel, equipment, supplies, contractual services, and specifics on how laboratory dollars should be allocated.

• Other management techniques and procedures necessary to ensure the quality and timeliness of all objectives.

• A complete description of the qualifications of each selected NPMMP staff member.

Prepare a description of the optimal approach to each task, including a working definition of anticipated problems, a description of specific features of the approach to the task, specific staff personnel involved, timing and logistical considerations, estimated resource requirements, and expected work products. Avoid generalized statements, e.g., following established procedures.

•  Task 1 . Develop a detailed plan on how to handle a call received from an individual reporting the following information: A private pesticide company treated the individuals home for ants and crickets and applied an organophosphate pesticide which the applicator said was extremely safe and could be applied while the family and pet cat was present. When questioned about the product being applied, the applicator refused to provide any additional information except that he had being using these products for years and was never ill from them. The caller explained that the application was made throughout the entire house and some carpets and furniture were actually soaked with the material. The caller also reported that within 24 hours she and her and two children were all complaining of headaches and dizziness, and that the 2-year child appeared to show an overall weakness. In addition, her cat was acting lethargic. The caller did not know whether they could all be getting the flu or whether it was really related to the pesticide treatment.

•  Task 2 : Develop a plan that will provide an efficient outreach method in order to better reach health care providers and other public health professionals in the services and findings provided by the NPMMP including the cost for such a project.

1. Available funding —i. NPIC . The funding for the selected award project is in the form of a cooperative agreement awarded under FIFRA section 20. The total funding available for award for NPIC in FY 2005 is expected to be approximately $1,475,000. At the conclusion of the first 1 year period of performance, incremental funding of up to $1,500,000 may be made available for each year allowing the project to continue for a total of 5 years and totaling up to $8,000,000 to $9,000,000 for the 5-year period, depending on the Agency budget in outlying years.

ii. NPMMP . The funding for the selected award project is in the form of a cooperative agreement awarded under FIFRA section 20. The total funding available for award for the Medical Monitoring project in FY 2005 is expected to be approximately $150,000. At the conclusion of the first 1 year period of performance, incremental funding of up to $150,000 may be available for each year allowing the project to continue for a total of 5 years and totaling up to $750,000 for the 5-year period, depending on the Agency's budget in outlying years.

Should additional funding become available for award, the Agency may make available additional funds under the cooperative agreements based on the solicitation and in accordance with the final selection process, without further notice of competition.

2. Evaluation process and criteria —i. NPIC . Applicants will be screened to ensure that they meet all eligibility criteria and will be disqualified if they do not meet all eligibility criteria. All eligible proposals will be reviewed, evaluated, and ranked by a selected panel of EPA reviewers based on the following evaluation criteria and weights (Total: 100 points):

Technical proposal (see Unit III.F.1. for details)----(Weighting: 30 points)

Academic experience (see Unit III.C.2.i.a. for details)----(Weighting: 15 points)

Technical experience (see Unit III.C.2.i.b. for details)----(Weighting: 25 points)

Sample Tasks (see Unit III.F.1. details)----(Weighting: 30 points, each task is worth 10 points)

ii. NPMMP . Applicants will be screened to ensure that they meet all eligibility criteria and will be disqualified if they do not meet all eligibility criteria. All proposals will be reviewed, evaluated, and ranked by a selected panel of EPA reviewers based on the following evaluation criteria and weights (Total: 100 points):

•  Technical proposal (see Unit III.F.2. for details)----(Weighting: 30 points)

•  Academic experience (see III.C.2.ii.a. for details)----(Weighting: 15 points)

•  Technical experience (see III.C.2.iii.b. for details)----(Weighting: 25 points)

•  Sample tasks (see Unit III.F.2. for details)----(Weighting: 30 points, each task is worth 15 points)

3. Selection official . For both NPIC and NPMMP, the funding decision will be made from the group of top rated proposals by the Division Director of the Information Resources and Services Division, Office of Pesticide Programs. The Agency reserves the right to reject all proposals and make no awards.

4. Dispute resolution process . The procedures for dispute resolution at 40 CFR 30.63 and 40 CFR 31.70 apply.

The following application requirements apply for both NPIC and NPMMP projects.

1. Content requirements . Proposals must be typewritten, double spaced in 12 point or larger print using 8.5 x 11 inch paper with minimum 1 inch horizontal and vertical margins. Pages must be numbered in order starting with the cover page and continuing through the appendices. One original and one electronic copy (e-mail or disk) is required.

All proposals must include:

• Completed Standard Form SF 424*, Application for Federal Assistance. Please include organization fax number and e-mail address. The application forms are available on line at http://www.epa.gov/ogd/grants/how_to_apply.htm .

• Completed Section B--Budget Categories, on page 1 of Standard Form SF 424A* (see allowable costs discussion below). Blank forms may be located at http://www.epa.gov/ogd/grants/how_to_apply.htm .

• Detailed itemization of the amounts budgeted by individual Object Class Categories (see allowable costs discussion below).

• Statement regarding whether this proposal is a continuation of a previously funded project. If so, please provide the assistance number and status of the current grant/cooperative agreement.

•  Executive Summary . The Executive Summary shall be a stand alone document, not to exceed one page, containing the specifics of what is proposed and what you expect to accomplish regarding measuring or movement toward achieving project goals. This summary should identify the measurable environmental results you expect including potential human health and ecological benefits.

•  Table of contents . A one page table listing the different parts of your proposal and the page number on which each part begins.

•  Proposal narrative . Includes Parts I-V as identified below (not to exceed 10 pages).

•  Part I--Project title . Self explanatory.

•  Part II--Objectives . A numbered list (1, 2, etc.) of concisely written project objectives, in most cases, each objective can be stated in a single sentence.

•  Part III--Justification . For each objective listed in Part II, discuss the potential outcome in terms of human health, environmental and/or pesticide risk reduction.

•  Part IV--Approach and methods . Describe in detail how the program will be carried out. Describe how the system or approach will support the program goals.

•  Part V--Impact assessment . Please state how you will evaluate the success of the program in terms of measurable results. How and with what measures will humans be better protected as a result of the program.

2. Appendices . These appendices must be included in the cooperative agreement proposal. Additional appendices are not permitted.

3. Timetable . A timetable that includes what will be accomplished under each of the objectives during the project and when completion of each objective is anticipated.

4. Major participants . List all affiliates or other organizations, educators, trainers and others having a major role in the proposal. Provide name, organizational affiliation or occupation and a description of the role each will play in the project. A brief resume (not to exceed two pages) should be submitted for each major project manager, educator, support staff, or other major participant.

5. Allowable costs . EPA grant funds may only be used for the purposes set forth in the cooperative agreement, and must be consistent with the statutory authority for the award. Cooperative agreement funds may not be used for matching funds for other Federal grants, lobbying, or intervention in Federal regulatory or adjudicatory proceedings. In addition, Federal funds may not be used to sue the Federal government or any other governmental entity. All costs identified in the budget must conform to applicable Federal Cost Principles contained in OMB Circular A-87; A-122; and A-21, as appropriate.

4. Federal requirements for recipients . All applicants should be aware that formal requests for assistance (i.e., SF 424 and associated documentation) may be subject to intergovernmental review under Executive Order 12372, “Intergovernmental Review of Federal Programs.” Applicants should contact their state's single point of contact (SPOC) for further information. There is a list of these contacts at the following web site: http:/whitehouse.gov/omb/grants/spoc.html .

1. Submission instructions . You may submit an application through the mail, by fax, or electronically. Regardless of submission method, all applications must be received by EPA on or before September 22, 2004.

As indicated above, each application must include the original paper copy of the submission, along with one electronic copy. The electronic copy of your application package, should be consolidated into a single file, and that you use Word Perfect WP8/9 for Windows, or Adobe pdf 4/5. Please check your electronic submissions to ensure that it does not contain any computer viruses.

Submit your application using one of the following methods:

By mail to: Frank L. Davido, Office of Pesticide Programs, Information Resources and Services Division, Mail code 7502C, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

By fax to: Frank Davido at fax number: (703) 305-4646.

By e-mail to: davido.frank@epa.gov .

2. Notification process . The NPIC/NPMMP Project Officer, Frank L. Davido, Public Information and Records Integrity Branch, Information Resources and Services Division, in OPP will mail an acknowledgment to applicants upon receipt of the application. Once all of the applications have been reviewed, evaluated, and ranked, applicants will be notified of the outcome of the two competitions. A listing of the successful proposals will be posted on the www.epa.gov/pesticides website at the conclusion of the competition. The website may also contain additional information about this announcement including information concerning deadline extensions or other modifications.

1. NPIC . The recipient will submit monthly, quarterly, an annual reports to the EPA Project Officer. The monthly and quarterly reports are due within 30 days after each reporting period. The monthly reports will include:

• A summary of number of calls for the month by major call group.

• A summary of pesticides from a certainty index classification, only those considered as definite/probable (certainty index classification and procedures will be provided to the recipient).

• Detailed summaries of those calls classified as definite and probable.

• A listing of the top 10 active ingredients involved in NPIC calls, including the incident calls.

• Issues of concern (possible trends/issues).

• Unusual events.

The quarterly reports should include: Work status; work progress; difficulties encountered; preliminary data results and a statement of activity anticipated during the subsequent reporting period, including a description of equipment, techniques, and materials to be used or evaluated. A discussion of expenditures along with a comparison of the percentage of the project completed to the project schedule and an explanation of significant discrepancies shall be included in the report. The report should also include any changes of key personnel concerned with the project. The annual report will be of high quality and submitted within 3 months after the reporting period. At minium, it should include an executive summary; project mission statement; NPIC update (inquiry update, achievements, personnel up date, facilities); and traffic report (details will be provided to the recipient). In addition, a separate financial report is required annually. It will include an annual accounting, a quarter, and monthly expenditures by budget categories, e.g., personnel, travel, and supplies. Financial reports/accounting can also be requested at any time.

The Project Officer may request additional information relative to the scope of work in the cooperative agreement which may be useful for Agency reporting under the Government Performance and Results Act.

2. NPMMP . The recipient will submit quarterly and an annual reports to the EPA Project Officer. The quarterly reports are due within 30 days after each reporting period. The quarterly reports should include: Work status; work progress; a description of inquiries and incidents relating to human pesticide incidents/exposures; unusual exposure scenarios cases and misapplications; difficulties encountered; preliminary data results and a statement of activity anticipated during the subsequent reporting period, including a description of equipment, techniques, and materials to be used or evaluated. A discussion of expenditures along with a comparison of the percentage of the project completed to the project schedule and an explanation of significant discrepancies shall be included in the report. The report should also include any changes of key personnel concerned with the project. The annual report will be of high quality and submitted within 3 months after the reporting period. At minium, it should include an executive summary; project mission statement; NPMMP update (inquiry update, achievements, personnel up date, facilities); and traffic report (details will be provided to the recipient). In addition, a separate financial report is required annually. It will include an annual accounting, a quarter, and monthly expenditures by budget categories, e.g., personnel, travel, and supplies. Financial reports/accounting can also be requested at any time.

The Project Officer may request additional information relative to the scope of work in the cooperative agreement which may be useful for Agency reporting under the Government Performance and Results Act.

Grant solicitations such as this are considered rules for the purpose of the Congressional Review Act (CRA) (5 U.S.C. 801 et seq .). The CRA generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this grant solicitation and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to its publication in the Federal Register . This rule is not a “major rule” as defined by 5 U.S.C. 804(2).

This action is directed to the public in general, and may be of particular interest to persons who are concerned about implementation of PRIA, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and the Federal Food, Drug, and Cosmetic Act (FFDCA). Other potentially affected entities may include but are not limited to agricultural workers and farmers; pesticide industry trade associations; environmental, consumer and farmworker groups; pesticide users and growers; pest consultants; State, local and Tribal governments; academia; public health organizations; food processors; and the public. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

1. Docket . EPA has established an official public docket for this action under docket identification (ID) number OPP-2004-0284. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1801 S. Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

2. Electronic access . You may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/ .

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select “search,” then key in the appropriate docket ID number.

The Office of Pesticide Programs (OPP) is entrusted with the responsibility of ensuring the safety of the American food supply, protection and education of those who apply or are exposed to pesticides occupationally or through use of products, and the general protection of the environment and special ecosystems from potential risks posed by pesticides.

PPDC was established under the Federal Advisory Committee Act (FACA), Public Law 92-463, in September 1995 for a 2-year term and has been renewed every 2 years since that time. PPDC provides advice and recommendations to OPP on a broad range of pesticide regulatory, policy, and program implementation issues that are associated with evaluating and reducing risks from use of pesticides. The following sectors are represented on the PPDC: Pesticide industry and trade associations; environmental/public interest and consumer groups; farm worker organizations; pesticide user, grower, and commodity groups; Federal and State/local/Tribal governments; the general public; academia; and public health organizations. Copies of the PPDC charter are filed with appropriate committees of Congress and the Library of Congress and are available upon request.

The revised draft Chapter 9 will be reviewed by CASAC on September 20, 2004, via a publically accessible teleconference. The arrangements for the CASAC meeting will be announced in a separate Federal Register notice.

In the Federal Register of January 23, 2002 (67 FR 3060), FDA published a final rule establishing criteria and procedures for additional conditions to become eligible for consideration in the OTC drug monograph system. These criteria and procedures, codified in § 330.14 (21 CFR 330.14), permit OTC drugs initially marketed in the United States after the OTC drug review began in 1972 and OTC drugs without any marketing experience in the United States to become eligible for FDA's OTC drug monograph system. The term “condition” means an active ingredient or botanical drug substance (or a combination of active ingredients or botanical drug substances), dosage form, dosage strength, or route of administration, marketed for a specific OTC use (§ 330.14(a)). The criteria and procedures also permit conditions that are regulated as cosmetics or dietary supplements in foreign countries but that would be regulated as OTC drugs in the United States to become eligible for the OTC drug monograph system.

Sponsors must provide specific data and information in a TEA to demonstrate that the condition has been marketed for a material time and to a material extent to become eligible for consideration in the OTC drug monograph system. When the condition is found eligible, FDA publishes a notice of eligibility and request for safety and effectiveness data for the proposed OTC use. The TEA that FDA reviewed (Ref. 1) and FDA's evaluation of the TEA (Ref. 2) have been placed on public display in the Division of Dockets Management (see ADDRESSES ) under the docket number found in brackets in the heading of this document. Information deemed confidential under 18 U.S.C. 1905, 5 U.S.C. 552(b), or 21 U.S.C. 331(j) was deleted from the TEA before it was placed on public display.

FDA intends to evaluate the condition S. boulardii , 250 mg (4.5 x 10 9 lyophilized, viable yeast cells) taken 1 to 2 times daily with a maximum daily dose of 500 mg (9.0 x 10 9 yeast cells), in capsule form for inclusion in the monograph for OTC antidiarrheal drug products (21 CFR part 335). Accordingly, FDA invites all interested persons to submit data and information, as described in § 330.14(f), on the safety and effectiveness of this active ingredient for FDA to determine whether it can be GRAS/E and not misbranded under recommended conditions of OTC use. The TEA did not include an official or proposed United States Pharmacopeia-National Formulary (USP-NF) drug monograph for S. boulardii . According to § 330.14(i), an official or proposed USP-NF monograph for S. boulardii must be included as part of the safety and effectiveness data for this ingredient. Interested parties should provide an official or proposed USP-NF monograph for evaluation by FDA.

Interested persons should submit comments, data, and information to the Division of Dockets Management. Three copies of all comments, data, and information are to be submitted. Individuals submitting written information or anyone submitting electronic comments may submit one copy. Submissions are to be identified with the docket number found in brackets in the heading of this document and may be accompanied by supporting information. Received submissions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Information submitted after the closing date will not be considered except by petition under 21 CFR 10.30.

Under § 330.14(h), any product containing the condition for which data and information are requested may not be marketed as an OTC drug in the United States at this time unless it is the subject of an approved new drug application or abbreviated new drug application.

The following references are on display in the Division of Dockets Management (see ADDRESSES ) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

In the Federal Register of August 4, 2004, FDA announced that a joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Pediatric Advisory Committee would be held on September 13 and 14, 2004. On page 47157, in the third column, the Addresses and on page 47158, in the second column, the Procedure portions are amended to read as follows:

Addresses : Electronic comments should be submitted to http://www.fda.gov/dockets/ecomments . Select “2004N-0330—Suicidality in Clinical Trials for Antidepressant Drugs in Pediatric Patients” and follow the prompts to submit your statement. Written comments should be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Comments received by August 23, 2004, will be provided to the committee before the meeting. Comments received after August 23, 2004, will be reviewed by FDA's decision makers.

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 Division of Dockets Management as stated in the Addresses section of this document. Oral presentations from the public will be scheduled between approximately 2 p.m. to 6 p.m. on September 13, 2004. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before 4:30 p.m. on August 27, 2004, 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. Docket “2004N-0330—Suicidality in Clinical Trials for Antidepressant Drugs in Pediatric Patients” will remain open for public submissions until July 29, 2005.

This notice is given under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR Part 14, relating to advisory committees.

FDA issued a final rule classifying gold-based alloys and precious metal alloys for clinical use and base metal alloy devices in the Federal Register of August 12, 1987 (52 FR 30082). These devices were classified before the provisions of the Safe Medical Devices Act of 1990 (SMDA) broadened the definition of class II devices to establish special controls beyond performance standards. FDA published a proposed rule in the Federal Register of December 1, 2003 (68 FR 67097) to amend the classification regulation of these class II devices. FDA received three comments.

FDA received one comment from a consumer and one (in duplicate) from a trade association. Both comments were in support of the proposed reclassification with minor modifications suggested. The consumer comment states that the name of the regulation “gold based alloys and precious metal alloys for clinical use” is unscientific because gold is, by definition, a precious metal. FDA agrees with this comment and has amended § 872.3060 (21 CFR 827.3060) to read “noble metal alloy” and deleted “for clinical use.”

The subject of the trade association comment was that the scope of the dental base metal alloys guidance is not clear as to what alloys are subject to the guidance. FDA agrees with this comment and has modified the scope of the guidance to define the devices not clearly addressed by the guidance.

The trade association comment also recommended that FDA's recommendation that the labeling for nickel-containing alloys contain a contraindication for hypersensitive individuals is unnecessary because nickel has been demonstrated to be biocompatible. FDA disagrees that the labeling should not contain a contraindication for nickel hypersensitive individuals. FDA believes that this warning is needed to minimize the potential for adverse events associated with improper use of this device.

Following the effective date of the final rule exempting the device, manufacturers of these devices will need to address the issues covered in this special control guidance. However, the manufacturer need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness. If manufacturers cannot comply with these recommendations or equivalent measures, they will not be exempt from the requirements of premarket notification and will need to submit a premarket notification and receive clearance for their device prior to marketing.

These draft guidances are being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidances represent the agency's current thinking on base metal alloy and noble metal alloy devices. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such an approach satisfies the requirements of the applicable statute and regulations.

These guidances contain information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) (the PRA). The collections of information addressed in the guidance documents have been approved by OMB in accordance with the PRA under the regulations governing premarket notification submissions (21 CFR part 807, subpart E, OMB control number 0910-0120). The labeling provisions addressed in the guidances have been approved by OMB under the PRA under OMB control number 0910-0485.

Interested persons may submit to the Division of Dockets Management (see ADDRESSES ), written or electronic comments regarding this document. Submit a single copy of electronic comments http://www.fda.gov/dockets/ecomments or two paper copies of any written comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Copies of the draft guidance documents and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

To receive “Class II Special Controls Guidance Document: Dental Noble Metal Alloys” by fax, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the voice prompt, press 1 to order a document. Enter the document number 1415 followed by the pound sign (#). Follow the remaining voice prompts to complete you request. To receive “Class II Special Controls Guidance Document: Dental Base Metal Alloys” by fax, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt, press 1 to order a document. Enter the document number 1416 followed by the pound sign (#). Follow the remaining voice prompts to complete your request. Persons interested in obtaining a copy of these draft guidances may also do so using the Internet. CDRH maintains a site on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, Federal Register reprints, information on premarket submissions (including lists of approved applications and manufacturers' addresses), small manufacturer's assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH web site may be accessed at http://www.fda.gov/cdrh . A search capability for all CDRH documents is available at http://www.fda.gov/cdrh/guidances.html . Guidance documents are also available on the Division of Dockets Management Internet site at http://www.fda.gov/ohrms/dockets .

The agenda for this meeting includes remarks by the Committee Co-Chairs, Randy Beardsworth, Director of Operations, Border and Transportation Security, Department of Homeland Security, and Deborah Daniels, Assistant Attorney General, Office of Justice Programs, Department of Justice; an update on current training initiatives of the National Center; and planning of strategic goals. This meeting is open to the public. Anyone desiring to attend must contact Reba Fischer, the Designated Federal Officer, no later than September 1, 2004, at (912) 267-2343, to arrange clearance.

Public Law 93-498, Fire Prevention and Control Act of 1974, as amended (the Act), created the National Fire Academy (NFA) to advance the professional development of fire service personnel and allied professionals. The Act provides the conduct of courses and programs of training and education, to train fire services personnel with skills and knowledge that may be useful to advance their ability to prevent and control fires, including tactics and command of firefighting for fire chiefs, commanders, and administration and management of fire services.

Collection of Information

Title: National Fire Academy Executive Fire Officer Program Application Form.

Type of Information Collection: Revision.

OMB Number: 1660-0021.

Form Numbers: FEMA Forms 95-22, Application for Admission, 75-5, General Admissions Application and 75-5 automated.

Abstract: The United States Fire Administration, National Fire Academy has an Executive Fire Officer Program to which senior level fire officers (such as Fire Department Chiefs, Assistant Chiefs, or individuals who are responsible for a major functional area within a fire service organization) may apply. Applicants must complete FEMA Form 95-22, National Fire Academy—Executive Fire Officer Program Application for Admission in conjunction with FEMA Form 75-5, General Admissions Application (which is already under OMB approval number 1660-0007). In addition, the following information should also be submitted:

• A letter from the applicant requesting admission to the program and specifying the applicant's qualifications; commitment to complete the entire program, including the applied research; and the applicant's perceived expectation(s) of the program.

• A resume.

• A letter of recommendation and support from the applicant's immediate supervisor indicating the organization's commitment to allow the applicant to complete the required courses and research.

• A photocopy of the applicant's terminal academic diploma or transcript.

• An organizational chart that depicts the applicant's position.

FEMA uses the application forms and supporting documentation to effectively screen and select applicants for the program.

Affected Public: Individuals or Households.

Estimated Total Annual Burden Hours:

Estimated Cost: There are no startup or operational/maintenance costs to respondents since there is no reporting or record keeping requirements associated with this information collection. The only cost to respondents is the one incurred as a direct result of the burden hours.

Comments: Written comments are solicited to (a) evaluate whether the proposed data collection is necessary for the proper performance of the agency, including whether the information shall have practical utility; (b) evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) enhance the quality, utility, and clarity of the information to be collected; and (d) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g. , permitting electronic submission of responses. Comments should be received within 60 days of the date of this notice.

The notice of a major disaster declaration for the State of Florida is hereby amended to include the following areas among those areas determined to have been adversely affected by the catastrophe declared a major disaster by the President in his declaration of August 13, 2004:

The notice of a major disaster declaration for the State of Florida is hereby amended to include the following areas among those areas determined to have been adversely affected by the catastrophe declared a major disaster by the President in his declaration of August 13, 2004:

Notice is hereby given that the incident period for this disaster is closed effective July 25, 2004.

Notice is hereby given that the incident period for this disaster is reopened. The incident period for this declared disaster is now May 20, 2004, through and including June 8, 2004.

MMS prepares CERs/EAs and FONSIs for proposals that relate to exploration for and the development/production of oil and gas resources on the Alaskan OCS. These CERs/EAs examine the potential environmental effects of activities described in the proposals and present MMS conclusions regarding the significance of those effects. CERs/EAs are used as a basis for determining whether or not approvals of the proposals constitute major Federal actions that significantly affect the quality of the human environment in the sense of NEPA Section 102(2)(C). A FONSI is prepared in those instances where MMS finds that approval will not result in significant effects on the quality of the human environment. The FONSI briefly presents the basis for that finding and includes a summary or copy of the CER.

This notice constitutes the public notice of availability of environmental documents required under the NEPA Regulations.

This listing includes all proposals for which the Alaska OCS Region prepared a FONSI in the period subsequent to publication of the preceding notice.

Persons interested in reviewing environmental documents for the proposals listed above or obtaining information about CERs/EAs and FONSIs prepared for activities on the Alaska OCS are encouraged to contact MMS at the address or telephone listed in the FOR FURTHER INFORMATION CONTACT section of this notice.

Background .—The final phase of this investigation is being scheduled as a result of an affirmative preliminary determination by the Department of Commerce that outboard engines from Japan are being sold in the United States at less than fair value within the meaning of section 733 of the Act (19 U.S.C. 1673b). The investigation was requested in a petition filed on January 8, 2004, by Mercury Marine, a division of Brunswick Corp., Fond du Lac, WS.

Participation in the investigation and public service list .—Persons, including industrial users of the subject merchandise and, if the merchandise is sold at the retail level, representative consumer organizations, wishing to participate in the final phase of this investigation as parties must file an entry of appearance with the Secretary to the Commission, as provided in section 201.11 of the Commission's rules, no later than 21 days prior to the hearing date specified in this notice. A party that filed a notice of appearance during the preliminary phase of the investigation need not file an additional notice of appearance during this final phase. The Secretary will maintain a public service list containing the names and addresses of all persons, or their representatives, who are parties to the investigation.

Limited disclosure of business proprietary information (BPI) under an administrative protective order (APO) and BPI service list .—Pursuant to section 207.7(a) of the Commission's rules, the Secretary will make BPI gathered in the final phase of this investigation available to authorized applicants under the APO issued in the investigation, provided that the application is made no later than 21 days prior to the hearing date specified in this notice. Authorized applicants must represent interested parties, as defined by 19 U.S.C. 1677(9), who are parties to the investigation. A party granted access to BPI in the preliminary phase of the investigation need not reapply for such access. A separate service list will be maintained by the Secretary for those parties authorized to receive BPI under the APO.

Staff report .—The prehearing staff report in the final phase of this investigation will be placed in the nonpublic record on December 2, 2004, and a public version will be issued thereafter, pursuant to section 207.22 of the Commission's rules.

Hearing .—The Commission will hold a hearing in connection with the final phase of this investigation beginning at 9:30 a.m. on December 14, 2004, at the U.S. International Trade Commission Building. Requests to appear at the hearing should be filed in writing with the Secretary to the Commission on or before December 8, 2004. A nonparty who has testimony that may aid the Commission's deliberations may request permission to present a short statement at the hearing. All parties and nonparties desiring to appear at the hearing and make oral presentations should attend a prehearing conference to be held at 9:30 a.m. on December 10, 2004, at the U.S. International Trade Commission Building. Oral testimony and written materials to be submitted at the public hearing are governed by sections 201.6(b)(2), 201.13(f), and 207.24 of the Commission's rules. Parties must submit any request to present a portion of their hearing testimony in camera no later than 7 days prior to the date of the hearing.

Written submissions .—Each party who is an interested party shall submit a prehearing brief to the Commission. Prehearing briefs must conform with the provisions of section 207.23 of the Commission's rules; the deadline for filing is December 9, 2004. Parties may also file written testimony in connection with their presentation at the hearing, as provided in section 207.24 of the Commission's rules, and posthearing briefs, which must conform with the provisions of section 207.25 of the Commission's rules. The deadline for filing posthearing briefs is December 21, 2004; witness testimony must be filed no later than three days before the hearing. In addition, any person who has not entered an appearance as a party to the investigation may submit a written statement of information pertinent to the subject of the investigation on or before December 21, 2004. On January 19, 2005, the Commission will make available to parties all information on which they have not had an opportunity to comment. Parties may submit final comments on this information on or before January 21, 2005, but such final comments must not contain new factual information and must otherwise comply with section 207.30 of the Commission's rules. All written submissions must conform with the provisions of section 201.8 of the Commission's rules; any submissions that contain BPI must also conform with the requirements of sections 201.6, 207.3, and 207.7 of the Commission's rules. The Commission's rules do not authorize filing of submissions with the Secretary by facsimile or electronic means, except to the extent permitted by section 201.8 of the Commission's rules, as amended, 67 FR 68036 (November 8, 2002).

In accordance with sections 201.16(c) and 207.3 of the Commission's rules, each document filed by a party to the investigation must be served on all other parties to the investigation (as identified by either the public or BPI service list), and a certificate of service must be timely filed. The Secretary will not accept a document for filing without a certificate of service.

The Commission issued a notice of investigation dated June 16, 2003, naming Auto Meter Products, Inc. (“Auto Meter”) of Sycamore, Illinois, as the complainant and several companies as respondents. On June 20, 2003, the notice of investigation was published in the Federal Register . 68 FR 37023. The complaint alleged violations of section 337 of the Tariff Act of 1930 in the importation and sale of certain automotive measuring devices, products containing same, and bezels for such devices, by reason of infringement of U.S. Registered Trademark Nos. 1,732,643 and 1,497,472, and U.S. Supplemental Register No. 1,903908, and infringement of the complainant's trade dress. Subsequently, seven more firms were added as respondents based on two separate motions filed by complainant Auto Meter. The investigation was terminated as to five respondents on the basis of consent orders.

On July 14, 2004, the ALJ issued two IDs (Orders Nos. 34 and 35) terminating the investigation as to respondents OldWorld/Splitfire and Blitz on the basis of settlement agreements and consent orders. The Commission investigative attorney filed responses in support of each of the joint motions. No petitions for review of the IDs were filed.