Title: National Nonprofit Humanitarian Program.

OMB Control Number: 0560-0227.

Date of Expiration: September 30, 2003.

Abstract: The Commodity Credit Corporation (CCC) has acquired approximately 1.2 billion pounds of nonfat dry milk (NDM) through its Milk Price Support Program. Limited shelf life for this commodity has prompted USDA's Farm Service Agency (FSA) to propose implementation of a 501(c)(3) program further utilizing CCC-owned NDM by selling the product to religious and non-religious nonprofit organizations in the United States. Under this proposal, CCC will deliver a minimum of four truckload quantities U.S. Extra Grade NDM or U.S. Extra Grade instantized fortified nonfat dry milk (INDM) to authorized recipients for the nominal fee of $20 per truckload. A minimum of two truckloads must be received per delivery period with each truckload consisting of one package size and product type (NDM or INDM). Recipients must demonstrate capability to store and handle the product in full compliance with applicable State and local health and food safety requirements to assure product wholesomeness. Recipients shall distribute the NDM or INDM in a timely manner for human consumption in the United States and shall not export, resell, exchange, or barter the product. Nonprofit organizations currently receiving NDM as a donated product from the U.S. Department of Agriculture, Food and Nutrition Service (FNS), under the Emergency Food Assistance Program (TEFAP) may also receive NDM under this program.

Estimate of Burden: Public reporting burden for this information collection is estimated to average 30 minutes per response.

Respondents: Nonprofit organizations.

Estimated Number of Respondents: 220.

Estimated Number of Annual Responses per Respondent: 1.

Estimated Total Annual Burden on Respondents: 321 hours.

Proposed topics for comments include: (a) 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; (b) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility and clarity of the information collected; or (d) ways to minimize the burden of the collection of the 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. Comments should be sent to the Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget, Washington, DC 20503 and to Beatrice Dove, Agricultural Marketing Specialist, Procurement and Donations Division, Commodity Operations Branch, Farm Service Agency, USDA, Stop 0551, 1400 Independence Avenue SW., Washington, DC 20250; telephone (202) 401-4652.

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

The Cooperative Forestry Assistance Act (CFAA) of 1978, as amended, (16 U.S.C. 2101 et seq.) provides authority for the Secretary of the U.S. Department of Agriculture (Secretary) to provide financial, technical, educational, and related assistance to States, communities, and private forest landowners. Section 1217 of Title XII of the Food, Agriculture, Conservation and Trade Act of 1990 (Pub. L. 101-624:104 Stat. 3359; 16 U.S.C. 2103c), also referred to as the 1990 Farm Bill, amends the CFAA and directs the Secretary to establish the Forest Legacy Program (FLP) to protect environmentally important forest areas that are threatened by conversion to nonforest uses. Through the 1996 Farm Bill (Federal Agricultural Improvement and Reform Act of 1996; Pub. L. 104-127; Title III—Conservation; Subtitle G—Forestry; Section 374, Optional State Grants for Forest Legacy Program), the Secretary is authorized, at the request of a participating State, to make a grant to the State to carry out FLP in that State, including the acquisition by the State of lands and interests in lands. Under section 6 of the Act of March 1, 1911, (16 U.S.C. 515), and section 11(a) of the Department of Agriculture Organic Act of 1956 (7 U.S.C. 428(a)), the Secretary of Agriculture continues to have authority to acquire environmentally important forest lands and interests therein for Federal acquisition, including conservation easements and rights of public access, with title vested in the U.S. Government. Both the State grant and the Federal acquisition programs operate on a willing seller and a willing buyer basis.

In 1996, the Forest Service issued the Forest Legacy Program Implementation guidelines, which were an update of the 1992 guidelines. In 2000, the Forest Service embarked on an effort to update the 1996 Guidelines, to provide clear and current direction to meet the needs of a rapidly growing national program. As part of the process, several drafts were circulated with open public comment periods resulting in hundreds of comments received and integrated into a draft document. However, in November 2001, when the revision was almost complete, the Surveys and Investigations Staff of the House of Representatives Appropriations Committee launched a 6-month investigation of the program. After a thorough review of FLP, the Congressional investigation findings required the Forest Service to develop additional direction related to key areas of the program, including: (1) The appraisal and appraisal review process, (2) the project selection process, (3) the process for redirecting and reprogramming project funds, and (4) the monitoring requirements for conservation easements.

The final 2003 Forest Legacy Program Implementation Guidelines reflect the work of a team of representatives from State lead agencies and Forest Service Washington Office and Regional offices. This team considered and integrated, to the extent practicable, all comments received throughout the process as well as the findings from the Congressional investigation. The guidelines will improve program operation, provide clarity on definitions, policy, and process, and respond to the findings of the Congressional report and direction.

The Forest Legacy Program Implementation Guidelines have four components:

Part 1—General Program Guidelines: Program direction applicable to all aspects of FLP, including Assessment of Need development, eligibility criteria, project selection process, process for redirection and reprogramming of funds, cost share requirements, landowner participation, appraisal and appraisal review, and conservation easement information.

Part 2—State Grant Program Guidelines: Program direction applicable to States and Forest Service Regions, Areas, and the International Institute of Tropical Forestry where a State has elected the State grant option and where ownership of lands or interests in lands is vested in a State or a subdivision of a State.

Part 3—Federal Acquisition Program Guidelines: Program direction applicable to States and Forest Service Regions, Areas, and the International Institute of Tropical Forestry selecting the Federal acquisition and ownership process, where ownership of lands or interests in lands is vested in the United States.

Appendices: Numerous appendices that provide supplemental information such as references to Office of Management and Budget circulars, qualifications required of an appraiser or review appraiser, an example cost share calculations, and a sample of FLP graphics.

The revised 2003 Forest Legacy Program Implementation Guidelines were mailed to State lead agencies, State Foresters (when different from the State lead agency), national partners, and Forest Service Regions, Areas, and the International Institute of Tropical Forestry.

Approval for the information collection requirements described in this Advance RFP was requested of the Office of Management and Budget (OMB) pursuant to a new collection request submitted before the publication of a related proposed rulemaking to provide for the policies and procedures relating, in part, to the agriculture innovation center demonstration program. This proposed regulation, and the related notice and request for comment on this information collection were published in the Federal Register on June 13, 2003, at 68 FR 35321 (“Proposed Rule”). An OMB control number would ordinarily be published concurrent with publication of the related final rule (“Final Rule”) after consideration of comments received in response to this paperwork notice. Accordingly, no OMB control number has been assigned at this time and the paperwork requirements included in this Advance RFP will not be effective until such time as the collection is approved and the control number assigned.

The deadline for the receipt of the application materials set forth in this RFP may not be earlier than the date the information collection is approved and the Final Rule is published. There is no guarantee that the information collection will be approved or that the related Final Rule will be published in time to obligate the funds available for Fiscal Year 2003.

In the event that a final rule has been promulgated and the information collect has been approved by awards cannot be made by September 30, 2003, it is USDA's intention that applications submitted after the effective date of the final rule will be held and considered for the award of Fiscal 2004 funds if and when Fiscal 2004 funds become available for this purpose.

The policies and procedures proposed for this new demonstration program are outlined in the Proposed Rule. This Advance RFP must be read in conjunction with the Proposed Rule. Until such time as the policies and procedures are published as a final rule and the associated paperwork requirements are approved OMB, RBS may not accept applications.

Parties interested in applying under this program are encouraged, but not required, to send a notice of intent to participate to the Agency conforming to the suggested template provided at the end of this Advance RFP (“Notice of Intent”). Those who submit a Notice of Intent will be sent an e-mail or fax by the Agency when the Final Rule is published and the Agency will accept applications. Submission of a Notice of Intent does not obligate a prospective applicant to apply. If a prospective applicant elects to avail themselves of this courtesy notification, the Notice of Intent to participate must be e-mailed to marc.warman@usda.gov.

This Advance RFP calls for applications that meet the requirements published in the Proposed Rule and includes cross references to the Proposed Rule in order to minimize a duplication of published material. In the event the RBS is not able to timely obligate FY 2003 funds, applications received will be held for consideration for FY 2004 funding as and when available. It is not contemplated that a revised RFP will be issued for FY 2004 except as provided below. Only applications that are timely received in response to this Advance RFP will be eligible for either FY 2003 or FY 2004 funding, as applicable.

In the event the Agency is successful in making FY 2003 awards, and is later in a position to make FY 2004 awards, a new RFP will be issued for FY 2004 funding. Applications received in response to this Advance RFP will be held and considered for FY 2004 funding if and only if it is not possible to make timely FY 2003 awards.

The Proposed Rule contemplates that applicants will be asked to suggest performance goals against which the performance of their Centers and successes of their value added projects are to be measured. The Proposed Rule also sets forth evaluation criteria that are to be used in evaluating grant applications. It provides that a given RFP may supplement these evaluation criteria. In this Advance RFP, USDA has included one supplemental evaluation criterion. This evaluation criterion looks at the quality of the performance criteria suggested by the applicant for evaluating the success of the proposed Center. Criteria which are ambitious, readily quantifiable and reflect serious consideration and seriousness of purpose will result in more points scored than proposed performance criteria that are superficial, reflect little or no challenge, and do not incorporate variables that reflect value-added results.

Section 6402 of the Farm Security and Rural Investment Act of 2002 (Pub. L. 107-171) (2002 Farm Bill) authorizes the Secretary of Agriculture to establish up to 10 agriculture innovation demonstration centers (Agriculture Innovation Centers or AICs) in Fiscal Year 2003. The purpose of these centers is to foster the ability of agricultural producers to reap the benefits of producing and marketing value-added products.

The Proposed Rule sets forth the proposed policies and procedures for this program. The Agency has elected not to wait until publication of a Final Rule before publishing this Advance RFP in order to alert potential applicants of the anticipated limited timing for the filing of application packages so as to maximize the possibility of awarding grants in FY 2003. While comments to the Proposed Rule may effect substantive changes to the final promulgated rule, it is the intention of this Advance RFP to give potential applicants as much lead time as possible to develop applications.

1. RBS will not make more than ten grant awards for FY 2003.

2. RBS will not make a grant to more than one entity in any one State.

3. A grant award may not exceed the lesser of $1,000,000 or twice the dollar amount (in cash or in kind) of the resources committed to the Center's operations apart from the program grant funds.

The reader is referred to the Proposed Rule for the proposed evaluation criteria listed there. Each criterion may be awarded up to five (5) points. This Advance Request for Proposals provides for the following, seventh, evaluation criterion:

Criteria suggested by the applicant pursuant to proposed § 4284.1009(c)(5)(v) that are ambitious, relevant and quantifiable and reflect serious consideration and seriousness of purpose will score more points than superficial performance criteria that reflect little or no challenge or that do not incorporate variables that reflect value-added results.

In the event of a tied score between two or more applications, the scores for the first individual criterion listed in the Proposed Rule will be compared, and the highest score for that individual criterion will break the tie. If the scores for the first criterion are tied, the scores for the second criterion will be compared, and so on.

Under the Proposed Rule at § 4284.1009, applicants must file an original and one copy of the required forms and proposal.

After the information collection has been approved by OMB and the Proposed Rule becomes final, applicants are encouraged, but not required, to submit applications and reports in electronic form. A complete, original application may be electronically sent as an e-mail attachment to marc.warman@usda.gov. If applications are submitted electronically, a signature page must be submitted via facsimile to the attention of Marc Warman at (202) 720-4641 or in hard copy to Marc Warman at the address provided at the beginning of this notice. Alternatively, an original application package plus one paper copy may be submitted to the addresses provided at the beginning of this notice.

The undersigned hereby expresses interest in applying for an agriculture innovation center grant pursuant to the Request for Proposals published by the USDA Rural Business-Cooperative Service (RBS) for Fiscal Year 2003. The purpose of this notice is solely to facilitate courtesy communication from RBS regarding the publication timing of the anticipated Final Rulemaking related to the Agriculture Innovation Center Grant Program.

Additions

On May 30, 2003, the Committee for Purchase From People Who Are Blind or Severely Disabled published notice (68 FR 32458) of proposed addition to the Procurement List. After consideration of the material presented to it concerning capability of the qualified nonprofit agency to provide the product and impact of the addition on the current or most recent contractor, the Committee has determined that the product list below is suitable for procurement by the Federal Government under 41 U.S.C. 46-48c and 41 CFR 51-2.4.

I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:

1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organizations that will furnish the product to the Government.

2. The action will result in authorizing small entities to furnish the product to the Government.

3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 46-48c) in connection with the product proposed for addition to the Procurement List.

Accordingly, the following product is added to the Procurement List:

Product/NSN: Belt, Women's Cotton Web, Black w/Gold Clip, 8445-01-501-0232.

NPA: Travis Association for the Blind, Austin, Texas.

Contract Activity: Defense Supply Center Philadelphia, Philadelphia, Pennsylvania.

On May 30, 2003, the Committee for Purchase From People Who Are Blind or Severely Disabled published notice (68 FR 32459) of proposed deletions to the Procurement List. After consideration of the relevant matter presented, the committee has determined that the services listed below are no longer suitable for procurement by the Federal Government under 41 U.S.C. 46-48c and 41 CFR 51-2.4.

I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:

1. The action may not result in any additional reporting, recordkeeping or other compliance requirements for small entities.

2. The action may result in authorizing small entities to furnish the services to the Government.

3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 46-48c) in connection with the services deleted from the Procurement List.

Accordingly, the following services are deleted from the Procurement List:

Service Type/Location: Janitorial/Custodial, Petroglyph National Monument Headquarters, 6001 Unser Boulevard NW, Albuquerque, New Mexico.

NPA: RCI, Inc., Albuquerque, New Mexico.

Contract Activity: Department of Interior.

Service Type/Location: Janitorial/Custodial, Social Security Administration, Data Operations Center and Annex, Albuquerque, New Mexico.

NPA: Adelante Development Center, Inc., Albuquerque, New Mexico.

Contract Activity: Social Security Administration, Baltimore, Maryland.

This notice is published pursuant to 41 U.S.C. 47(a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.

If the Committee approves the proposed additions, the entities of the Federal Government identified in this notice for each service will be required to procure the service listed below from nonprofit agencies employing persons who are blind or have other severe disabilities.

I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:

1. If approved, the action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organizations that will furnish the service to the Government.

2. If approved, the action will result in authorizing small entities to furnish the service to the Government.

3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 46-48c) in connection with the service proposed for addition to the Procurement List. Comments on this certification are invited. Commenters should identify the statement(s) underlying the certification on which they are providing additional information.

The following service is proposed for addition to Procurement List for production by the nonprofit agency listed:

I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:

1. If approved, the action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities.

2. If approved, the action will result in authorizing small entities to furnish the products to the Government.

3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 46-48c) in connection with the products proposed for deletion from the Procurement List.

The following products are proposed for deletion from the Procurement List:

The Department's procedures for the conduct of sunset reviews are set forth in 19 CFR 351.218. Guidance on methodological or analytical issues relevant to the Department's conduct of sunset reviews is set forth in the Department's Policy Bulletin 98.3—Policies Regarding the Conduct of Five-Year (“Sunset”) Reviews of Antidumping and Countervailing Duty Orders; Policy Bulletin, 63 FR 18871 (April 16, 1998) (“Sunset Policy Bulletin”).

In accordance with 19 CFR 351.218(c), we are initiating sunset reviews of the following antidumping and countervailing duty orders:

As a courtesy, we are making information related to sunset proceedings, including copies of the Department's regulations regarding sunset reviews (19 CFR 351.218) and Sunset Policy Bulletin, the Department's schedule of sunset reviews, case history information (i.e., previous margins, duty absorption determinations, scope language, import volumes), and service lists, available to the public on the Department's sunset Internet website at the following address: http://ia.ita.doc.gov/sunset/.

All submissions in these sunset reviews must be filed in accordance with the Department's regulations regarding format, translation, service, and certification of documents. These rules can be found at 19 CFR 351.303. Also, we suggest that parties check the Department's sunset website for any updates to the service list before filing any submissions. The Department will make additions to and/or deletions from the service list provided on the sunset website based on notifications from parties and participation in this review. Specifically, the Department will delete from the service list all parties that do not submit a substantive response to the notice of initiation.

Because deadlines in a sunset review are, in many instances, very short, we urge interested parties to apply for access to proprietary information under administrative protective order (“APO”) immediately following publication in the Federal Register of the notice of initiation of the sunset review. The Department's regulations on submission of proprietary information and eligibility to receive access to business proprietary information under APO can be found at 19 CFR 351.304-306.

Domestic interested parties (defined in 19 CFR 351.102(6)) wishing to participate in these sunset reviews must respond not later than 15 days after the date of publication in the Federal Register of the notice of initiation by filing a notice of intent to participate. The required contents of the notice of intent to participate are set forth at 19 CFR 351.218(d)(1)(ii). In accordance with the Department's regulations, if we do not receive a notice of intent to participate from at least one domestic interested party by the 15-day deadline, the Department will automatically revoke the order without further review. See 19 CFR 351.218(d)(1)(iii).

If we receive an order-specific notice of intent to participate from a domestic interested party, the Department's regulations provide that all parties wishing to participate in the sunset review must file complete substantive responses not later than 30 days after the date of publication in the Federal Register of the notice of initiation. The required contents of a substantive response, on an order-specific basis, are set forth at 19 CFR 351.218(d)(3). Note that certain information requirements differ for respondent and domestic interested parties. Also, note that the Department's information requirements are distinct from the International Trade Commission's information requirements. Please consult the Department's regulations for information regarding the Department's conduct of sunset reviews.1 Please consult the Department's regulations at 19 CFR Part 351 for definitions of terms and for other general information concerning antidumping and countervailing duty proceedings at the Department.

This notice of initiation is being published in accordance with section 751(c) of the Act and 19 CFR 351.218(c).

Section 9 of the ESA and Federal regulations prohibit the “taking” of a species listed as endangered or threatened. The term take is defined under the ESA to mean harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or to attempt to engage in any such conduct. Harm is defined by NMFS to include significant habitat modification or degradation where it actually kills or injures fish or wildlife by significantly impairing essential behavioral patterns, including breeding, spawning, rearing, feeding, and sheltering (50 CFR 222.102).

Two types of permits may be issued by NMFS under section 10(a) of the ESA to non-Federal landowners to take listed species, under certain terms and conditions. These regulations governing NMFS' permits for threatened and endangered species are promulgated at 50 CFR 222.307. The first of these permits is the Enhancement of Survival Permit, which is authorized under section 10(a)(1)(A) of the ESA. The second of these permits is the ITP, which is authorized under section 10(a)(1)(B) of the ESA.

An application for an ITP must be accompanied by a Habitat Conservation Plan for which the Secretary of Commerce finds that: (1) the taking will be incidental; (2) the applicant will, to the maximum extent practicable, minimize and mitigate the impacts of such taking; (3) the applicant will ensure that adequate funding for the conservation plan will be provided; (4) the taking will not appreciably reduce the likelihood of survival and recovery of the species in the wild; and (5) such other measures NMFS may require as necessary or appropriate for the purposes of the HCP. HCPs can address both listed and currently unlisted species.

The District has applied to NMFS for an ITP under Section 10(a)(1)(B) of the ESA for its Mad River operations. The District is the sole supplier of domestic and “raw” industrial water to the greater Humboldt Bay area. The District sells treated water for domestic consumption on a wholesale basis to the cities of Eureka, Arcata, and Blue Lake, and to the Humboldt, McKinleyville, Fieldbrook, and Manila Community Services Districts. The District also sells untreated “raw” water on a wholesale basis to industrial users on the Samoa Peninsula, located on the north spit of Humboldt Bay. The District obtains its water through diversions from the Mad River.

The District's diversion facilities are located approximately 8 river miles (13 km) upstream from the mouth of the Mad River, near the town of Essex. The District diverts water utilizing two separate systems: (1) A domestic system, which supplies treated drinking water; and (2) an industrial system, which supplies untreated “raw” water. Water for the domestic system is withdrawn using four Ranney collectors situated in the Mad River. These collectors withdraw subsurface water from 60 to 90 ft (18 to 27 m) below the surface of the river bed. Water for the industrial system is withdrawn using a surface diversion facility referred to as Station 6. The District also manages flow releases from Matthews Dam at Ruth Lake, a 48,000 acre-feet (592 million Hectoliter) reservoir located approximately 85 river miles (137 km) upstream from the mouth of the Mad River. The District releases water from Matthews Dam during the low flow summer months to meet its diversion needs at the Essex facilities and its in-stream flow obligations below the Essex facilities.

The District has developed the Plan, with technical assistance from NMFS, to obtain an ITP for their activities related to the diversion of water from the Mad River. Activities proposed for ITP coverage include: (1) Releasing flow from Matthews Dam; (2) maintaining adequate capacity in the Matthews Dam tailrace and spillway pools; (3) diverting water from the Mad River in the vicinity of Essex (subsurface via Ranney collectors and surface via direct diversion facility (Station 6)); (4) gaining access to and maintaining Ranney collectors; (5) operation of Station 6 and its associated fish screens; (6) dredging the Station 6 forebay; (7) maintaining adequate flow to Station 6; (8) maintaining adequate water surface elevation at Station 6 during low flow months; (9) protecting banks and structures by repairing existing rock structures and/or revetments; and (10) bypassing flows below diversion facilities in the vicinity of Essex. The ITP and Plan will also cover required monitoring activities. The duration of the proposed ITP and Plan is 50 years.

The proposed ITP would authorize take, incidental to otherwise lawful activities, of fish in three evolutionarily significant units (ESUs) that are currently listed as threatened: the California Coastal chinook salmon (Oncorhynchus tshawytscha) ESU (CC chinook), the Southern Oregon/Northern California Coasts coho salmon (O. kisutch) ESU (SONCC coho), and the Northern California steelhead (O. mykiss) ESU (NC steelhead). NMFS anticipates implementation of the Plan may result in take of juvenile CC chinook, SONCC coho, and NC steelhead in the form of impingement or entrainment during diversion of surface flow and stranding, crushing, entombment, or modification of rearing habitat as a result of instream construction and operation of equipment.

NMFS prepared a draft Environmental Assessment concerning the proposed Plan and ITP and has made a preliminary determination that preparation of an Environmental Impact Statement is not necessary.

NMFS invites comment on the Plan, IA, and draft EA, the scope of alternatives and impacts to be considered, and effects to cultural and historic properties during the 30-day comment period which ends September 2, 2003. Comments should focus on the merits of the Plan, IA, and draft EA, ITP issuance requirements, the scope of alternatives and impacts to be considered, and effects to cultural and historic properties. Comments on other issues will be considered as beyond the scope of the decision associated with the ITP and Plan.

Hard bound copies of the ITP Application, Plan, IA, and draft EA are also available for viewing, or partial or complete duplication at the following libraries: (1) Eureka Main Library,1313 Third Street, Eureka, CA; Telephone (707) 269-1900; (2) Fortuna Branch, Humboldt County Library; 775 Fourteenth Street, Fortuna, CA; Telephone (707) 725-3460; (3) Arcata Branch, Humboldt Library, 500 Seventh Street, Arcata, CA; Telephone (707) 822-5954; (4) Weaverville Branch, Trinity Library, 211 North Main St., Weaverville, CA; Telephone (530) 623-1373; 5) Hayfork Branch, Trinity Library, Hyampom Rd., Hayfork, CA; Telephone (530) 628-5427. These documents are also available on the Internet at http://swr.nmfs.noaa.gov.

This notice is provided pursuant to section 10(c) of the ESA, National Environmental Policy Act (NEPA) regulations, and National Historic Preservation Act (NHPA) regulations. NMFS will evaluate the ITP application, associated documents, and submitted comments to determine whether the ITP application and associated documents meet the requirements of the ESA, NMFS' regulations for implementing NEPA (40 CFR 1506.6), and NHPA section 106 regulations (36 CFR 800). NMFS is furnishing this notice to allow other agencies and the public an opportunity to review and comment on these documents, to scope alternatives and impacts to be considered, and comment on effects to cultural and historic properties. All comments received will be available for review pursuant to section 10(c) of the ESA. The final ITP decision will be made no sooner than 30 days after date of publication of this notice in the Federal Register.

Regulations at 50 CFR 648.9 set forth VMS requirements for fisheries in the northeastern United States that require the use of VMS for fishery monitoring and/or reporting. Specifically, § 648.9(b) lists minimum VMS performance criteria that a VMS unit must meet in order to be certified for use. If and when a new or modified unit becomes available, the Administrator, Northeast Region, NMFS (Regional Administrator) may, under the provisions of § 648.9(a), certify that unit for use, if it meets the minimum performance criteria.

The Thrane & Thrane TT-3026M VMS unit is being evaluated for certification in Northeast fisheries that require the use of VMS. In order to provide field-testing information to the Regional Administrator, OLE has designed a voluntary pilot program. Specific focus of the pilot program will be the at-sea testing on the setting of the Days-at-Sea (DAS) activity codes using the freeform e-mail capability of the TT-3026M unit.

The pilot program duration will be from 30 to 60 days, and will utilize six vessels of various sizes and configurations in the Northeast multispecies (groundfish) and Atlantic sea scallop fisheries. One unit has already been installed and activated on a local groundfish vessel that will be included in the pilot program. Therefore, five additional vessels are being sought to participate in the pilot program. Participant selection will be based upon vessel length, mast configuration, available power sources, principal port, permit type, personal computer (PC) knowledge level of the operator, and the anticipated fishing activity during the pilot program period. Applicants for the pilot program may provide this information to OLE by requesting, completing and returning a single-page application (see ADDRESSES). All expenses related to the installation and operation of the unit, within the scope of the pilot program, will be paid by OLE.

Once participant selection is finalized, the VMS units will be installed on selected vessels in accordance with the manufacturer's guidelines; using local marine electronic vendors. The installer will be required to make the appropriate connections to the PC onboard the vessel and to load the easyMail software, which comes with the TT-3026M. OLE will provide laptop PCs for those vessels that do not already have PCs on board. Once the VMS unit is installed and powered up, the installer will send a test message to OLE and then contact the OLE VMS staff to verify that the message was received and that the VMS unit is operating normally.

The vessel operator will be provided an information packet from OLE that contains instructions for communications with OLE via the VMS unit and step-by-step instructions for sending and receiving activity code changes via the easyMail program. OLE will also provide contact information, so that unforeseen difficulties with the VMS unit or software can be resolved in a timely manner. A test script will be provided to the pilot program vessels to test specific functionality of the system used by OLE to process DAS Activity Code changes. OLE will review the test results and perform any necessary system adjustments.

At the conclusion of the pilot program, interviews with the vessel operators will be conducted to solicit feedback and to obtain suggestions for system changes or enhancements. The VMS unit, along with any ancillary equipment, will be removed from the vessel. The vessel owner will have the option of retaining the control cable, if so desired; otherwise, it will be removed.

The requested amendment has been granted under the authority of the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq.) and the provisions of 50 CFR 222.306 of the regulations governing the taking, importing, and exporting of endangered and threatened fish and wildlife (50 CFR 222-226).

The modification extends the expiration date of the Permit from July 31, 2003, to July 31, 2004, for takes of green (Chelonia mydas), loggerhead (Caretta caretta), and Kemp's ridley (Lepidochelys kempii) sea turtles. It also updates Special Condition C.10. (the net check interval) and adds Special Condition C.12 (sterile research procedures) to the permit to reflect current recommended protocols in order to ensure the safety and health of the sea turtles taken by the research activities.

Issuance of this amendment, as required by the ESA was based on a finding that such permit: (1) Was applied for in good faith; (2) will not operate to the disadvantage of the threatened and endangered species which are the subject of this permit; and (3) is consistent with the purposes and policies set forth in section 2 of the ESA.

Panel To Assess the Capabilities for Domestic Response to Terrorist Attacks Involving Weapons of Mass Destruction will meet from 9 a.m. until 5 p.m. on September 3, 2003 and from 8:30 a.m. until 12 p.m. on September 4, 2003. Time will be allocated for public comments by individuals or organizations at the end of the meeting on September 4.

Public comment presentations will be limited to two minutes each and must be provided in writing prior to the meeting. Mail written presentations and requests to register to attend the open public session to: Hillary Peck, RAND, 1200 South Hayes Street, Arlington, VA 22202-5050. Public seating for this meeting is limited, and is available on a first-come, first-served basis.

Research and Development proposals and continuing projects requesting Strategic Environmental Research and Development Program funds in excess of $1M will be reviewed.

This meeting is open to the public. Any interested person may attend, appear before, or file statements with the Scientific Advisory Board at the time and in the manner permitted by the Board.

This document gives notice of revisions in per diem rates prescribed by the Per Diem Travel and Transportation Allowance Committee for non-foreign areas outside the continental United States. It supersedes Civilian Personnel Per Diem Bulletin Number 232. Distribution of Civilian Personnel Per Diem Bulletins by main was discontinued. Per Diem Bulletins published periodically in the Federal Register now constitute the only notification of revisions in per diem rates to agencies and establishments outside the Department of Defense. For more information or questions about per diem rates, please contact your local travel office. The text of the Bulletin follows:

Stipend Level: The Secretary will determine the JKJ fellowship stipend for the academic year 2004-2005 based on the level of support provided by the National Science Foundation (NSF) graduate fellowships as of February 1, 2004, except that the amount will be adjusted as necessary so as not to exceed the JKJ fellow's demonstrated level of financial need.

Institutional Payment: The Secretary will determine the institutional payment for the 2004-2005 academic year by adjusting the previous academic year institutional payment, which is $11,296 per fellow, by the U.S. Department of Labor's Consumer Price Index for the 2003 calendar year. The institutional payment will be reduced by the tuition and fees the institution charges and collects from a JKJ fellow.

For Applications Contact: Federal Student Aid Information Center, P.O. Box 84, Washington DC 20044-0084. Telephone (toll free): 1-800-433-3243, FAX: (319) 358-4316. The application may also be accessed on the JKJ Fellowship Program Web site: http://www.ed.gov/offices/OPE/HEP/iegps/javits.html.

If you use a telecommunications device for the deaf (TDD), you may call the Federal Information Relay Service (FIRS) at 1-800-877-8339.

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

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 David Dollins at the address listed above or by telephone at (270) 441-6819. Requests must be received five 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 comments will be provided a maximum of five minutes to present their comments as the first item of the meeting agenda.

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 at the Department of Energy's Environmental Information Center and Reading Room at 115 Memorial Drive, Barkley Centre, Paducah, Kentucky between 8 a.m. and 5 p.m. on Monday thru Friday or by writing to David Dollins, Department of Energy Paducah Site Office, Post Office Box 1410, MS-103, Paducah, Kentucky 42001 or by calling him at (270) 441-6819.

The information collection submitted for OMB review contains the following:

1. Collection of Information: FERC-585 “Reporting of Electric Energy Shortages and Contingency Plans under PURPA 206.”

2. Sponsor: Federal Energy Regulatory Commission.

3. Control No. 1902-0138.

The Commission is now requesting that OMB approve a three-year extension of the expiration date, with no changes to the existing collection. The information filed with the Commission is mandatory. Requests for confidential treatment of the information are provided for under Section 388.112 of the Commission's regulations.

1. Necessity of the Collection of Information: Submission of the information is necessary to enable the Commission to carry out its responsibilities in implementing the statutory provisions of Section 206 of the Public Utility Regulatory Policies Act of 1978 (PURPA) (Pub. L. 95-617, 92 Stat. 3117) which amended Section 202 of the Federal Power Act by adding subsection (g). Section 202(g) requires public utilities to report to the Commission, and appropriate State agencies, any unanticipated shortages of electric energy or capacity which would affect the utility's ability to serve its wholesale customers and to report and periodically revise, their contingency plans for such occurrences which would equitably accommodate both retail and wholesale customers.

The Commission uses the contingency plan information to evaluate and formulate appropriate options for action in the event an anticipated shortage is reported or materializes. The Commission also uses this information ensure itself and firm power wholesale customers that both are kept informed about utility contingency plans and anticipated shortages of energy and capacity and to ensure that direct and indirect customers would be treated without undue prejudice or disadvantage during actual shortages.

If the contingency plan data is not provided, the statutory provisions of the FPA and PUPRA will not have been complied with, and information will not be available to assess whether utilities have planned for shortage conditions and/or developed plans with due consideration for equitable customer treatment, as required by the established statute. The Commission implements these filing requirements in the Code of Federal Regulations (CFR) under 18 CFR part 294.

5. Respondent Description: The respondent universe currently comprises approximately 170 public utilities. In the normal course of a public utility's operations, contingency plans are prepared and usually reviewed and updated periodically. However, the burden on each utility will vary primarily with respect to the number and size of wholesale customers and utility system customers supplied by the reporting utility. The number of respondents is based on the actual number of responses that were received by the Commission since the last OMB submission.

6. Estimated Burden: 511 total hours, 7 respondents (average), 1 response per respondent, 73 hours per response (average).

7. Estimated Cost Burden to respondents: 511 hours/2080 hours per years × $117,041 per year = $28,753.

Summary: Pursuant to the Federal Advisory Committee Act, Public Law 92-463, Notice is hereby given that the Panel will hold a public meeting to provide advice to the EPA on the Agency's Computational Toxicology Framework. The date and time for the meeting are provided above.

Background: Background on the Panel and the focus of the meeting described in this notice was provided in a Federal Register notice published on April 30, 2003 (68 FR 23131-23132). A draft document, “A Framework for a Computational Toxicology Research Program at ORD” can be found on the EPA Web site at http://www.epa.gov/nheerl.

Availability of Meeting Materials: Copies of any available meeting materials, including a draft agenda, will be posted on the SAB Web site for this panel at http://www.epa.gov/sab/panels/ctfcpanel.html approximately 10 days before the meeting.

Providing Oral or Written Comments at SAB Meetings: It is the policy of the EPA Science Advisory Board (SAB) Staff Office to accept written public comments of any length, and to accommodate oral public comments whenever possible. The EPA SAB Staff Office expects that public statements presented at its meetings will not be repetitive of previously-submitted oral or written statements. Oral Comments: In general, each individual or group requesting an oral presentation at a face-to-face meeting will be limited to a total time of ten minutes (unless otherwise indicated). For teleconference meetings, opportunities for oral comment will usually be limited to no more than three minutes per speaker and no more than fifteen minutes total. Deadlines for getting on the public speaker list for a meeting are given above. Speakers should bring at least 35 copies of their comments and presentation slides for distribution to the reviewers and public at the meeting. Written Comments: Although written comments are accepted until the date of the meeting (unless otherwise stated), written comments should be received in the SAB Staff Office at least one week prior to the meeting date so that the comments may be made available to the committee for their consideration. Comments should be supplied to Dr. Rowe at the address/contact information noted above in the following formats: One hard copy with original signature, and one electronic copy via e-mail (acceptable file format: Adobe Acrobat, WordPerfect, Word, or Rich Text files (in IBM-PC/Windows 95/98 format)). Those providing written comments and who attend the meeting are also asked to bring 35 copies of their comments for public distribution.

Meeting Accommodations: Individuals requiring special accommodation to access the public meetings listed above, should contact Dr. Rowe at least five business days prior to the meeting so that appropriate arrangements can be made.

PACHA was established by Executive Order 12963, dated June 14, 1995, as amended by Executive Order 13009, dated June 14, 1996. The Council was established to provide advice, information, and recommendations to the Secretary regarding programs and policies intended to (a) promote effective prevention of HIV disease, (b) advance research on HIV and AIDS, and (c) promote quality services to persons living with HIV disease and AIDS. PACHA was established to serve solely as an advisory body to the Secretary of Health and Human Services. The Council is composed of not more than 35 members. Council membership is selected by the Secretary from individuals who are considered authorities with particular expertise in, or knowledge of, matters concerning HIV/AIDS.

The agenda for this Council meeting will include the following topics: Implementation of new HIV/AIDS prevention guidelines and HIV/AIDS international issues.

Public attendance at the meeting is limited to space available. Individuals must provide a photo ID for entry into the meeting. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the designated contact person. Members of the public will have the opportunity to provide comments at the meeting. Preregistration is required for public comment. Any individual who wishes to participate in the public comment session should call the telephone number listed in the contact information to register. Public comment will be limited to five minutes per speaker. Any members of the public who wish to have printed material distributed to PACHA members should submit materials to the Acting Executive Director, PACHA, whose contact information is listed above prior to close of business August 4, 2003.

This notice is being published less than 15 days in advance of the meeting due to issues pertaining to technical arrangements.

The Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Public Law 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of Patents and Trademarks may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

FDA recently approved for marketing the human drug product SPECTRACEF (cefditoren pivoxil). SPECTRACEF is indicated for treatment of acute exacerbation of chronic bronchitis, pharyngitis/tonsillitis, and uncomplicated skin and skin structure infections. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for SPECTRACEF (U.S. Patent No. 4,839,350) from Meiji Seika Kaisha, Ltd., and the Patent and Trademark Office requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated February 4, 2003, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of SPECTRACEF represented the first permitted commercial marketing or use of the product. Shortly thereafter, the Patent and Trademark Office requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for SPECTRACEF is 1,461 days. Of this time, 851 days occurred during the testing phase of the regulatory review period, while 610 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective: August 31, 1997. The applicant claims August 30, 1997, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was August 31, 1997, which was 30 days after FDA receipt of the IND.

2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the act: December 29, 1999. FDA has verified the applicant's claim that the new drug application (NDA) for SPECTRACEF (NDA 21-222) was initially submitted on December 29, 1999.

3. The date the application was approved: August 29, 2001. FDA has verified the applicant's claim that NDA 21-222 was approved on August 29, 2001.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,032 days of patent term extension.

Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments and ask for a redetermination by January 29, 2004. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by January 29, 2004. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Comments and petitions should be submitted to the Division of Dockets Management. Three copies of any mailed information are to be submitted, except that individuals may submit one copy. Copies are to be identified with the docket number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Section 738 of the act (21 U.S.C. 379j), establishes fees for different kinds of medical device applications. Fees are assessed on certain types of medical device applications and supplements. When certain conditions are met, FDA may waive or reduce fees (21 U.S.C. 379j(d) and (e)).

For FY 2003 through FY 2007, MDUFMA (Public Law 107-250) establishes revenue amounts for the aggregate of all application fee revenues. Revenue amounts established for years after FY 2003 are subject to adjustment for inflation, workload, and compensation for revenue shortfalls from previous years. Fees for applications are to be established each year by FDA so that revenues will approximate the levels established in the statute, after those amounts have been first adjusted for inflation, workload, and, if required, revenue shortfalls from previous years.

This notice establishes fee rates for FY 2004. These fees are effective on October 1, 2003, and will remain in effect through September 30, 2004.

MDUFMA specifies that the fee revenue amount for FY 2004 is $27,255,000, before any adjustments are made (21 U.S.C. 379j(b)).

MDUFMA provides that fee revenue amounts for each FY after 2003 shall be adjusted for inflation. The adjustment must reflect the greater of: (1) The total percentage change that occurred in the Consumer Price Index (CPI) (all items; U.S. city average) during the 12-month period ending June 30 preceding the FY for which fees are being set, or (2) the total percentage pay change for the previous FY for Federal employees stationed in the Washington, DC metropolitan area. MDUFMA provides for this annual adjustment to be cumulative and compounded annually after 2003 (see 21 U.S.C. 379j(c)(1)).

The inflation adjustment for FY 2004 is 4.27 percent. This is the greater of the CPI increase during the 12-month period ending June 30 preceding the FY for which fees are being set (June 30, 2003—which was 2.11 percent) or the increase in pay for the previous FY (2003) for Federal employees stationed in the Washington, DC metropolitan area (4.27 percent). No compounding is applied to this amount because there was no inflation increase applied in FY 2003.

The inflation-adjusted revenue amount for FY 2004 is the statutory fee amount ($27,255,000) increased by 4.27 percent, the inflation adjuster for FY 2004. The FY 2004 inflation-adjusted revenue amount is $28,418,789.

For each FY beginning in FY 2004, MDUFMA provides that fee revenue amounts, after they have been adjusted for inflation, shall be further adjusted to reflect increases in workload for the process for the review of medical device applications (see 21 U.S.C. 379j(c)(2)). FDA's current assessment reflects that the change in total review workload as defined in MDUFMA has changed by less than 1 percent. Based on this assessment, FDA is not applying a workload adjustment to the FY 2004 inflation-adjusted revenue amount of $28,418,789. The need for workload adjustment will be assessed anew next year when FY 2005 fees are established.

For each FY beginning in FY 2004, MDUFMA provides that fee revenue amounts, after they have been adjusted for inflation and workload, shall be further adjusted, if necessary, to compensate for the cumulative shortfall in fee revenue from previous years (see 21 U.S.C. 379j(c)(3)). In FY 2003, FDA had expected to collect a total of $25,125,000 in MDUFMA fees, the fee revenue amount stated in the statute (see 21 U.S.C. 379j(b)). As of June 30, 2003, for 9 months of the fiscal year, total fee collections were $14,360,304. If fee collections in the last 3 months are proportional to collections in the first 9 months, FDA will collect another $4,786,768 million—for a total of about $19,147,000 million for the year. In addition FDA expects to collect about $500,000 of outstanding accounts receivable, for a FY 2003 estimated total fee collection of $19,647,000. This is $5,478,000 million less than the statutory revenue amount for FY 2003.

In implementing the compensating adjustment provision, FDA will increase the FY 2004 revenue amount by the amount of the revenue shortfall in FY 2003, $5,478,000. Accordingly, adding $5,478,000 to the inflation-adjusted revenue amount of $28,418,789 derived above (see section II.B of this document), provides a final adjusted revenue amount for FY 2004 of $33,896,789. Fees for FY 2004 are being set to generate this amount of revenue.

Under MDUFMA, the amount of fee revenue collected is a function of two factors—the fee rate for the application and the number of applications that will pay each type of fee.

To set fees for FY 2004, FDA must first estimate the number of applications that will pay each type of fee. For FY 2003, before MDUFMA was enacted, FDA estimated the number of applications that would pay each type of fee. That estimate was based on the average number of each category of applications over the 5-year period before MDUFMA was enacted, FY 1997 through FY 2001. These estimates took into account FDA's estimates of the number of applications that would qualify for a small business reduction or exemption. (It should be noted that the two-tier fee structure for 510(k)'s is to begin in FY 2004.) The original FY 2003 estimates are shown in Table 1 of this document.

The reason that MDUFMA fee revenues are projected to fall approximately $5,478,000 short of the revenue target in FY 2003 is that FDA collected fewer full fees than projected for Original PMAs and BLAs and their full-fee supplements, and fewer fees for 180-day supplements. The major reasons for this are twofold. A number of the applications were “bundled,” using guidance developed after MDUFMA was enacted, and did not have to pay separate fees. In addition, the agency received fewer full PMAs, BLAs and 180-day supplements in the first 9 months of FY 2003 than the 5-year averages estimated. Because of this, FDA considered basing fees for FY 2004 on lower estimates of the number of full PMA/BLA fees and 180-day supplement fees. This would have resulted in even higher fees for FY 2004.

The agency decided against revising estimated numbers of fee-paying applications in setting the FY 2004 fees, however, because such a revision would have been based on data from too brief a period—the 3 months from April 1 through June 30, 2003, during which applications were not accepted for filing unless the fee was paid. Instead, the agency will continue to use its original estimate of the numbers of fee-paying applications (see Table 1 of this document) again in setting fees for FY 2004.

FDA will reassess whether or not it needs to adjust its original estimates of the number of each type of fee-paying application a year from now when it sets fees for FY 2005. At that time the agency will have 15 months of data to use to determine whether its original estimates for annual numbers of applications were too high.

Under MDUFMA, all fees are set as a percent of the full fee for a PMA (see 21 U.S.C. 379j(a)(1)(A)). In order to generate $33,896,789 in FY 2004, using the above estimates of the numbers of each type of application that will pay a fee at each rate (see Table 1 of this document), the rate for a full PMA will be $206,811 for FY 2004. For all applications other than premarket notification submissions, the small business rate is 38 percent of the full fee rate (see 21 U.S.C. 379j(d)(2)(C)). For premarket notification submissions (510(k)'s), the small business rate is 80 percent of the full rate for premarket notification submissions (see 21 U.S.C. 379j(e)(2)(C)(i)). The FY 2004 fee rates for all application categories are set out in Table 2 of this document.

Under the provisions of MDUFMA, if the agency collects more fees than were provided for in appropriations in any year, FDA is required to reduce its anticipated fee collections in a subsequent year by that amount (21 U.S.C. 379j(h)(4)). No adjustments under this provision are required for fees assessed in FY 2004. If fees assessed in FY 2004 should inadvertently result in excess collections in FY 2004, then when fees are set for FY 2005 a reduction in fee rates for FY 2005 will be made for any excess collections that may have occurred in FY 2004.

Firms with annual gross sales and revenues of $30 million or less, including gross sales and revenues of all affiliates, partners, and parent firms, may qualify for a fee waiver for their first PMA, and for lower rates for subsequent PMA's, premarket reports, supplements, and premarket notification submissions.

Even if a firm qualified under MDUFMA as a small business in FY 2003, it must obtain a new small business certification and decision number for FY 2004 and for each subsequent fiscal year. This can be initiated any time after the publication of this notice. For FY 2004, firms that have not received a FY 2004 small business qualification decision number from FDA will not be permitted to submit the reduced small business fees. FDA urges firms to apply for this qualification 60 days before they intend to submit their application and fee.

To qualify, you are required to submit the following:

• Certified copies of your Federal Income Tax Return for the most recent taxable year (2002 or later), including certified copies of the income tax returns of your affiliates, partners, and parent firms.

• A certified list of all parents, partners, and affiliate firms since October 1, 2002.

You can find information for determining if an applicant qualifies for a small business first-time PMA waiver and lower rates for subsequent applications on the FDA Web site at http://www.fda.gov/oc/mdufma. At that Web site, under the heading “Guidance Documents,” click on the link “Qualifying as a Small Business.” This Web site provides detailed instructions and the address for mailing documentation to support qualification as a small business under MDUFMA.

Any application or supplement subject to fees under MDUFMA that is received on or after October 1, 2003, through September 30, 2004, is subject to the FY 2004 fee rate. It is the date that the application is received in the reviewing center's document room that determines whether the fee rates for FY 2003 or FY 2004 apply—not the date that FDA receives the payment. FDA must receive the correct fee at the time that an application is submitted, or the application will not be accepted for filing or review.

FDA requests that you follow the steps below before submitting a medical device application subject to a fee. Please pay close attention to these procedures to ensure that FDA links the fee with the correct application. (Note: In no case should the check for the fee be submitted to FDA with the application.)

Sections 735 and 736 of the act (21 U.S.C. 379g and h), establish three different kinds of user fees. Fees are assessed on: (1) Certain types of applications and supplements for approval of drug and biological products, (2) certain establishments where such products are made, and (3) certain products (see 21 U.S.C. 379h(a)). When certain conditions are met, FDA may waive or reduce fees (see 21 U.S.C. 379h(d)).

For FY 2003 through FY 2007 revenue amounts for application fees, establishment fees, and product fees are established by PDUFA III (the Prescription Drug User Fee Amendments of 2002, title 5 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002). Revenue amounts established for years after FY 2003 are subject to adjustment for inflation and workload. Fees for applications, establishments, and products are to be established each year by FDA so that revenues from each category will approximate the levels established in the statute, after those amounts have been first adjusted for inflation and workload. The revenue levels established by PDUFA III continue the arrangement under which one-third of the total user fee revenue is projected to come from each of the three types of fees: Application fees, establishment fees, and product fees.

This notice establishes fee rates for FY 2004 for application, establishment, and product fees. These fees are effective on October 1, 2003, and will remain in effect through September 30, 2004.

PDUFA III specifies that the fee revenue amount for FY 2004 for each category of fees (application, product, and establishment) is $77,000,000, before any adjustments are made, for a total of $231,000,000 from all three categories of fees (see 21 U.S.C. 379h(b)).

PDUFA III provides that fee revenue amounts for each FY after 2003 shall be adjusted for inflation. The adjustment must reflect the greater of: (1) The total percentage change that occurred in the consumer price index (CPI) (all items; U.S. city average) during the 12-month period ending June 30 preceding the FY for which fees are being set, or (2) the total percentage pay change for the previous FY for Federal employees stationed in the Washington, DC, metropolitan area. PDUFA III provides for this annual adjustment to be cumulative and compounded annually after FY 2003 (see 21 U.S.C. 379h(c)(1)).

The inflation adjustment for FY 2004 is 4.27 percent. This is the greater of the CPI increase during the 12-month period ending June 30 preceding the FY for which fees are being set (June 30, 2003—which was 2.11 percent) or the increase in pay for the previous FY (2003 in this case) for Federal employees stationed in the Washington, DC, metropolitan area (4.27 percent). No compounding is applied to this amount because there was no inflation increase applied in FY 2003.

The inflation-adjusted revenue amount for each category of fees for FY 2004 is the statutory fee amount ($77,000,000) increased by 4.27 percent, the inflation adjuster for FY 2004. The FY 2004 inflation-adjusted revenue amount is $80,287,900 for each category of fee, for a total inflation-adjusted fee revenue amount of $240,863,700 in FY 2004.

For each FY beginning in FY 2004, PDUFA III provides that fee revenue amounts, after they have been adjusted for inflation, shall be further adjusted to reflect changes in workload for the process for the review of human drug applications (see 21 U.S.C. 379h(c)(2)).

The conference report accompanying the PDUFA III, House of Representatives report number 107-481, provides additional instructions on how the workload adjustment provision of PDUFA III is to be implemented. Following that guidance, FDA calculated the average number each of the four types of applications specified in the workload adjustment provision (human drug applications, commercial investigational new drug applications, efficacy supplements, and manufacturing supplements) received over the 5-year period that ended on June 30, 2002 (base years), and the average number of each of these types of applications over the most recent 5-year period that ended June 30, 2003.

The results of these calculations are presented in the first 2 columns of table 1 of this document Column 3 reflects the percent change in workload over the two 5-year periods. Column 4 shows the weighting factor for each type of application, reflecting how much of the total FDA drug review workload was accounted for by each type of application in the table during the most recent 5 years. This weighting factor was developed by applying data generated in a 2002 KPMG study of FDA's drug review workload to submission data for the most recent 5-year period. Column 5 of table 1 of this document, is the weighted percent change in each category of workload, and was derived by multiplying the weighting factor in each line in column 4 by the percent change from the base years in column 3. At the bottom right of the table the sum of the values in column 5 is added, reflecting a total change in workload of negative 1.4 percent for FY 2004.

PDUFA III specifies that the workload adjuster may not result in fees that are less than the inflation-adjusted revenue amount. For this reason, the workload adjustment will not be applied in FY 2004, and the inflation-adjusted revenue amount for each category of fees for FY 2004 ($80,287,900) becomes the revenue target for fees in FY 2004, for a total inflation-adjusted fee revenue target in FY 2004 of $240,863,700 for fees from all three categories.

PDUFA III provides that the rates for application, product, and establishment fees be established 60 days before the beginning of each FY (see 21 U.S.C. 379h(c)(4)). The fees are to be established so that they will generate the fee revenue amounts specified in the statute, as adjusted for inflation and workload.

The application fee revenue amount that PDUFA III established for FY 2004 is $80,287,900, as calculated in the previous section. Application fees will be set to generate this amount.

For FY 2003 through FY 2007, FDA will estimate the total number of fee-paying full application equivalents (FAEs) it expects to receive the next FY by averaging the number of fee-paying FAEs received in the five most recent fiscal years. This use of the rolling average of the five most recent fiscal years is the same method that was applied in making the workload adjustment.

In estimating the number of fee-paying FAEs that FDA will receive in FY 2004, the 5-year rolling average for the most recent 5 years will be based on actual counts of fee-paying FAEs received for fiscal years 1999 through 2003. For FY 2003, FDA is estimating the number of fee-paying FAEs for the full year based on the actual count for the first 9 months and estimating the number for the final 3 months.

Table 2 of this document shows, in column 1, the total number of each type of FAE received in the first 9 months of FY 2003, whether fees were paid or not. Column 2 shows the number of FAEs for which fees were waived or exempted during this period, and column 3 shows the number of fee-paying FAEs received through June 30, 2003. Column 4 estimates the 12-month total fee-paying FAEs for FY 2003 based on the applications received through June 30, 2003. All of the counts are in FAEs. A full application requiring clinical data counts as one FAE. An application not requiring clinical data counts one-half an FAE, as does a supplement requiring clinical data. An application that is withdrawn or refused for filing counts as one-fourth of an FAE if it initially paid a full application fee, or one-eighth of an FAE if it initially paid one-half of the full application fee amount.

In the first 9 months of FY 2003 FDA received 111.5 FAEs, of which 88 were fee-paying. Based on data from the last 7 FYs, on average, 25 percent of the applications submitted each year come in the final 3 months. Dividing 88 by 3 and multiplying by 4, extrapolates the amount to the full 12 months of the FY and projects the number of fee-paying FAEs in FY 2003 at 117.3.

All pediatric supplements, which had been exempt from fees prior to January 4, 2002, were required to pay fees effective January 4, 2002. This is the result of section 5 of the Best Pharmaceuticals for Children Act that repealed the fee exemption for pediatric supplements effective January 4, 2002. Thus, in estimating FY 2004 fee-paying receipts, we must add all the pediatric supplements that were previously exempt from fees prior to January 4, 2002. The exempted number of FAEs for pediatric supplements for FY 1999, FY 2000, FY 2001, and FY 2002 respectively were 5.3, 12.5, 19, and 4.5. Since fees on these supplements will be paid for pediatric applications submitted in FY 2004, the number of pediatric supplement FAEs exempted from fees each year from FY 1999 through FY 2002 (the years in the table when fees were exempted) are added to the total of fee-paying FAEs received each year.

As table 3 shows, the average number of fee-paying FAEs received annually in the most recent 5-year period, assuming all pediatric supplements had paid fees, and including our estimate for FY 2003, is 140.0 FAEs. FDA will set fees for FY 2004 based on this estimate as the number of full application equivalents that will pay fees.

The FY 2004 application fee is estimated by dividing the estimated number of full applications that will pay fees, 140, into the fee revenue amount to be derived from application fees in FY 2004, $80,287,900. The result, rounded to the nearest one hundred dollars, is a fee of $573,500 per full application requiring clinical data, and $286,750 per application not requiring clinical data or per supplement requiring clinical data.

Under the provisions of PDUFA, as amended, if the agency collects more fees than were provided for in appropriations in any year after 1997, FDA is required to reduce its anticipated fee collections in a subsequent year by that amount (see 21 U.S.C. 379h(g)(4)).

In FY 1998, Congress appropriated a total of $117,122,000 to FDA in PDUFA fee revenue. To date, collections for FY 1998 total $117,737,470—a total of $615,470 in excess of the appropriation limit. This is the only fiscal year since 1997 in which FDA has collected more in PDUFA fees than Congress appropriated.

FDA also has some requests for waivers or reductions of FY 1998 fees that have been decided but that are pending appeals. For this reason, FDA is not reducing its FY 2004 fees to offset excess collections at this time. An offset will be considered in a future year, if FDA still has collections in excess of appropriations for FY 1998 after the pending appeals for FY 1998 waivers and reductions have been resolved.

At the beginning of FY 2003, the establishment fee was based on an estimate that 354 establishments would be subject to and would pay fees. By the end of FY 2003, FDA estimates that 379 establishments will have been billed for establishment fees, before all decisions on requests for waivers or reductions are made. FDA again estimates that a total of 25 establishment fee waivers or reductions will be made for FY 2003, for a net of 354 fee-paying establishments. FDA will use this number, 354, for its FY 2004 estimate of establishments paying fees, after taking waivers and reductions into account. The fee per establishment is determined by dividing the adjusted total fee revenue to be derived from establishments ($80,287,900) by the estimated 354 establishments, for an establishment fee rate for FY 2004 of $226,800 (rounded to the nearest one hundred dollars).

At the beginning of FY 2003, the product fee was based on an estimate that 2,293 products would be subject to and pay product fees. By the end of FY 2003, FDA estimates that 2,260 products will have been billed for product fees, before all decisions on requests for waivers or reductions are made. Assuming that there will be about 35 waivers and reductions made, FDA estimates that 2,225 products will qualify for product fees in FY 2003, after allowing for waivers and reductions, and will use this number for its FY 2004 estimate. Accordingly, the FY 2004 product fee rate is determined by dividing the adjusted total fee revenue to be derived from product fees ($80,287,900) by the estimated 2,225 products for a FY 2004 product fee of $36,080 (rounded to the nearest ten dollars).

The fee rates for FY 2004 are set out in table 4 of this document:

The appropriate application fee established in the new fee schedule must be paid for any application or supplement subject to fees under PDUFA that is submitted after September 30, 2003. Payment must be made in U.S. currency by check, bank draft, or U.S. postal money order payable to the order of the Food and Drug Administration. Please include the user fee identification (ID) number on your check. Your check can be mailed to: Food and Drug Administration, P.O. Box 360909, Pittsburgh, PA 15251-6909

If checks are sent by a courier that requests a street address, the courier can deliver the checks to: Food and Drug Administration (360909), Mellon Client Service Center, rm. 670, 500 Ross St., Pittsburgh, PA 15262-0001. (Note: This Mellon Bank address is for courier delivery only.)

Please make sure that the FDA post office box number (P.O. Box 360909) is on the enclosed check. The tax ID number of the FDA is 530 19 6965.

By August 31, 2003, FDA will issue invoices for establishment and product fees for FY 2004 under the new Fee Schedule. Payment will be due on October 1, 2003. FDA will issue invoices in October 2004 for any products and establishments subject to fees for FY 2004 that qualify for fees after the August 2003 billing.

FDA is announcing the availability of a guidance for industry entitled “180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same Day.” This guidance document provides information to sponsors and/or applicants regarding how the agency intends to determine eligibility for 180-day exclusivity under section 505(j)(5)(B)(iv) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C 355(j)(5)(B)(iv)) when multiple ANDA applicants submit a paragraph IV certification to a listed patent on the same day and no paragraph IV certification to the patent has been submitted on any previous day.

A new drug application (NDA) applicant must include in its NDA information about any patents that claim the drug product that is the subject of the NDA or the use of such drug product (section 505(b)(1) and (c)(2) of the act). FDA publishes this patent information upon approval of the NDA or a supplemental NDA in “Approved Drug Products with Therapeutic Equivalence Evaluations,” which is generally known as the “Orange Book.”

An ANDA applicant must include in its ANDA a patent certification as described in section 505(j)(2)(A)(vii) of the act. The certification must make one of the following statements: (1) Such patent information has not been filed; (2) such patent has expired; (3) the date on which such patent expires; or (4) such patent is invalid or will not be infringed by the manufacture, use, or sale of the drug product for which the ANDA is submitted. This last certification is known as a paragraph IV certification. The ANDA applicant must provide appropriate notice of a paragraph IV certification to each owner of the patent that is the subject of the certification and to the holder of the approved NDA to which the ANDA refers (section 505(j)(2)(B)(i) of the act (part 314 (21 CFR part 314))).

The act provides an incentive for generic drug manufacturers to file paragraph IV certifications and challenge listed patents as invalid or not infringed, thereby permitting generic drugs to reach the market more quickly. Section 505(j)(5)(B)(iv) of the act provides for a 180-day period of marketing protection for certain ANDA products as follows:

The statute does not further define the phrase “for which a previous application has been submitted.” In its regulation at § 314.107(c), FDA uses both the terms “previously submitted” and “first” in implementing this provision of the statute. It adopts the phrase “for which one or more substantially complete abbreviated new drug applications were previously submitted” to restate the conditions under which exclusivity will apply. The regulation at § 314.107(c)(1)(i) states that exclusivity may begin to run from “[t]he date the applicant submitting the first application first commences commercial marketing of its drug product.” The phrase “applicant submitting the first application” is defined in the regulation as “the applicant that submits an application that is both substantially complete and contains a certification that the patent was invalid, unenforceable, or not infringed prior to the submission of any other application for the same listed drug that is both substantially complete and contains the same certification.” (§ 314.107(c)(2)) Thus, the agency has adopted the terms “previous,” “first,” and “prior” to identify the ANDA eligible for exclusivity. However, the agency has not elaborated on how these terms should be applied when more than one applicant submits a paragraph IV certification to the same patent on the same day.

The statute and the regulations at § 314.107(c) are straightforward to apply when ANDAs, amendments, or supplements are submitted to FDA on different days. An ANDA submitted on the day before another application is submitted, when no application has been submitted on an earlier day, is clearly the “previous,” the “prior” and the “first” application. To date, FDA's exclusivity decisions have involved applications or amendments submitted on different days, and thus have not required additional interpretation of the statute or regulations on this point.

Recently, FDA has had to consider how to apply the 180-day exclusivity provision when multiple challenges to the same patent are submitted on the same “first” day. After the decisions in Mova Pharmaceuticals, Inc. v. Shalala, 140 F.3d 1060 (D.C.Cir. 1998) andGranutec, Inc. v. Shalala, 46 U.S.P.Q.2d 1398 (4th Cir. 1998), the first applicant who submits a substantially complete ANDA containing a paragraph IV certification to a listed patent is eligible for 180-day generic drug exclusivity.1 As noted in a 1999 citizen petition response,2  many of the current regulations were adopted prior to the Mova decision, when the agency interpreted the statute to require that an ANDA applicant had to be sued and win its patent litigation to qualify for 180-day exclusivity. FDA's pre-Mova interpretation limited the number of times 180-day exclusivity was awarded because an ANDA applicant had to be first to challenge a patent and then win the patent litigation to be eligible for 180-day exclusivity. The chance of having multiple ANDA applicants qualify for 180-day exclusivity was extremely low, as evidenced by the number of times that 180-day exclusivity was granted.3 By contrast, after the Mova decision, it is now relatively easy to qualify for 180-day exclusivity. As a result, FDA has had to address a number of new issues, including eligibility for exclusivity when multiple paragraph IV certifications are submitted on the same day.

Congress did not address the possibility that multiple applicants would submit patent challenges to FDA on the same day in the 180-day exclusivity provisions of the act. Similarly, FDA regulations now in effect do not address this specific situation. However, in an August 1999 proposed rule addressing 180-day exclusivity issues, FDA proposed an approach whereby all applicants submitting a paragraph IV certification to a patent on the first day such a certification is submitted are “first applicants” for 180-day exclusivity purposes (64 FR 42873, August 6, 1999). FDA received comments both for and against this approach (see Docket No. 85N-0214). The August 1999 proposed rule was withdrawn in November 2002 for reasons unrelated to the merits of the multiple first applicant approach (67 FR 66593, November 1, 2002). When the proposed rule was withdrawn, the agency noted it would continue to regulate directly from the statute and any applicable regulations, and make decisions on an issue-by-issue basis. The agency continues to believe that the approach to multiple first day patent challenges described in the proposed rule is a reasonable and appropriate interpretation of the statute. Two citizen petitions have specifically asked the agency to follow the approach described in the proposed rule when addressing 180-day exclusivity in cases where there are multiple ANDAs containing challenges to the same patent(s) submitted on the same day (see Docket Nos. 00P-1445 and 03P-0217).

Same day patent challenges generally occur when the expiration of 4 years of a 5-year exclusivity period under section 505(j)(5)(D)(ii) of the act permits submission of ANDAs containing a paragraph IV certification as of a specific date, and multiple applicants vie to be first to make such a submission. Multiple submissions on the same day may also occur when a new patent is issued by the Patent and Trademark Office and submitted to FDA by the NDA sponsor after ANDAs have been submitted. Because new patents must be submitted to FDA within 30 days of issuance, ANDA applicants position themselves to be the first to submit a paragraph IV certification as soon as the patent is submitted to FDA, often exactly 30 days after patent issuance.

Implementation of a rule that determined eligibility for 180-day exclusivity by the minute or second of submission would be problematic for several reasons. First, applications arrive at CDER by different means and at different locations. They are delivered by U.S. mail, delivery service, courier, and in person by the applicant or its agent.4 They may be delivered to mailrooms at FDA's Parklawn Bldg. or at its Metro Park North Bldg., which have different zip codes and are miles apart (§ 314.440). Second, when multiple ANDAs are delivered to the mailrooms on the same day, there is no effective way to determine in what order the documents were submitted. Also, when more than one application is present in a given delivery, the order in which the applications are date-stamped by the document room is random and reflects only the application's arbitrary place in the pile of mail. Moreover, a submission delivered to the agency early in the day may, in fact, be date-stamped after a submission delivered later in the day because the former submission was underneath the latter in the mail pile. Third, some ANDA applicants have assumed that hand delivery would be the best way to secure the “first” application slot. Applicants have arrived outside of an FDA-occupied building on or before the date on which ANDAs may be submitted. Recently, there have been a number of cases in which multiple ANDA applicants or their representatives have camped out adjacent to an FDA-occupied building for periods ranging from 1 day to more than 3 weeks to await the first date on which applications could be submitted to the agency. FDA does not have a system for determining which of those multiple applicants who are present either before the date of submission, or at 12:01 a.m. on the date of submission, or when FDA opens its doors to receive submissions, should be considered “first.” The order of applicants in a line that has formed before applications may be submitted is as random as the location of an application in a pile of mail in the mailroom.

Where multiple applicants are simultaneously present to submit patent certifications on the first day that such submissions are made, rewarding only the first applicant in line does not further any of the goals of the Hatch-Waxman amendments. Even if it were reasonable to argue that someone who is willing to stand in line for days or months should benefit by being considered the first to submit a patent challenge, security and other concerns have foreclosed that option.

The agency can no longer permit applicants to line up outside FDA-occupied buildings in advance of the date ANDA submissions are permitted. For example, when an applicant arrived outside of the FDA-occupied building in mid-May 2003 to establish first place for a number of ANDA submissions, one of which could not be submitted until mid-December 2003, the owner of the government-leased building informed FDA in a June 4, 2003, letter that the 24-hour presence of the pharmaceutical company representatives violated the policy described in the rules and regulations governing the use of the property. In addition, the owner noted its serious liability concerns regarding safety and security. Because of the owner's concerns, FDA directed the waiting ANDA applicant representative to leave the premises.

Furthermore, measuring submissions by the minute or second would be inconsistent with CDER's general administrative practices. CDER conducts its business by calendar day, not by the hour, minute, or second. For example, NDA review times under the Prescription Drug User Fee Act are based upon the date an application was submitted, and approvals are effective as of the date of the issuance of the approval letter (§ 314.105). In addition, 180-day exclusivity runs for 180 calendar days from the date of a commercial marketing or court decision triggering event, without regard to the precise time of day the exclusivity was triggered (§ 314.107(c)(1)). CDER considers most documents, including NDAs, ANDAs, and application amendments and supplements, to have been submitted to FDA as of the date-stamped on the document by the appropriate CDER document room.

In considering how to apply the 180-day exclusivity provisions to multiple patent challenges, FDA reviewed a number of possible approaches. First, the agency examined whether there was a safe and practical way to determine whose patent challenge is actually submitted to the agency first. The only way to ensure the order of submission would be to require all submissions to be made in person, with the establishment of some kind of monitored line. The owner of the FDA-occupied building has given the agency the option of permitting applicants to line up outside the building at 12:01 a.m. on the morning submissions may be accepted. However, such lines would raise issues of security and fairness for applicants and could lead to evidentiary disputes over which applicant, if any, was in line first. FDA is already aware of at least one instance in which an applicant videotaped its arrival on government property in an attempt to document that it was first to submit a patent challenge. Thus, this approach could lead to administrative proceedings and litigation over tie-breaking virtually simultaneous submissions. In addition, such an approach would disadvantage applicants who do not make submissions in person, because mail deliveries are likely to be made to FDA after the door opens for in person submissions.

The agency also considered requiring submission by mail and then date- and time-stamping submissions based on the order they were processed by the mailroom and document room. This approach would require FDA to determine, from among the various submissions made in the same delivery, which submission was first, itself an arbitrary process. Is the first submission the first ANDA to be removed from the mail bag, or the document on top of the pile after the mail is removed from the delivery container?

The agency even considered adopting a lottery approach, in which one ANDA would be chosen at random from among all the eligible ANDAs submitted on the same first day. This approach, although appealing in its simplicity and no less random than mail delivery or an applicant's place in line, has no support in the statute.

Finally, FDA considered permitting submission by facsimile. However, this approach raises many practical concerns involving after-hours submissions, jammed fax machines, and disputes over submission order. In sum, all of these approaches were rejected because they raise safety concerns, are administratively unworkable, or would arbitrarily and unfairly distinguish between similarly situated applicants. In addition, none of them addresses the fundamentally arbitrary nature of declaring any one patent challenge made on a certain day to be previous to all other challenges made on that day.

FDA intends to interpret the phrase “for which a previous application has been submitted” in section 505(j)(4)(B)(iv) of the act to mean an ANDA that has been submitted on a previous day. Thus, when multiple ANDAs containing paragraph IV challenges to patents are submitted to FDA on the same day—and no paragraph IV certification to that patent has been submitted on a previous day—FDA intends to consider none of the patent challenges to be previous to other challenges to the same patent submitted on the same day and all of those challenges as previous to paragraph IV certifications to the same patent submitted on a subsequent day. This is the general interpretation described in the 1999 proposed rule.

Under this approach, all of the applicants submitting substantially complete ANDAs, amendments, or supplements containing a paragraph IV certification for a listed patent on the same first day would be eligible for 180-day exclusivity. That exclusivity would begin to run for all of the applicants eligible for 180-day exclusivity from the earlier of the initial commercial marketing of the drug by any of the first applicants or by a court decision finding the specific patent as to which the applicants were first to file paragraph IV certifications invalid, unenforceable, or not infringed. During the exclusivity period, FDA may approve any other first applicant's ANDA, but no other ANDAs. Any first applicant's ANDA approved after the exclusivity has been triggered will share in the remaining period of exclusivity. Once the 180-day exclusivity period has run, FDA may approve all subsequent ANDAs.

The agency believes that this exclusivity approach is consistent with the statutory language in that, under at least one reasonable reading of section 505(j)(5)(B)(iv) of the act, none of the applications submitted on the same day is “previous” to any other application submitted on the same day, and all applications submitted on the same day are previous to any application submitted on any day thereafter.

This interpretation is also consistent with the intent of both the 180-day exclusivity provision, in particular, and the Hatch-Waxman Amendments, in general. Instead of giving exclusivity to a single applicant who may be first only by dint of jockeying for a better place in line, or by the happenstance of location within a pile of mail, this approach recognizes that all of the applicants who challenged a patent on the first day such a challenge is submitted challenged the patent at essentially the same time, and rewards them accordingly.

The approach maintains the incentive to be first to submit a patent challenge but, in the case where there are multiple applicants submitting patent challenges on the same first day, it will provide an equal chance at the benefits of exclusivity to all of those applicants. The approach will also provide the opportunity to be the sole beneficiary of exclusivity if an applicant obtains approval of its ANDA and begins to market at least 180 days before any of the other first applicants begins to market.

Finally, this approach will permit applicants to submit ANDAs by U.S. mail, courier, delivery service, or in person on a more reasonable timetable; preserve the safety and security of the applicants and FDA property and staff; and prevent time-consuming disputes over “who's first,” which rely on video and other evidence.

This guidance is being issued as a level 1 guidance for immediate implementation, consistent with FDA's good guidance practices regulation (21 CFR 10.115). The agency believes that given the need for public guidance on this pressing issue and existing liability, safety, and security concerns, public comment is neither feasible nor appropriate before implementing this guidance. Comments on the guidance are welcome at any time.

FDA intends to implement this approach immediately for all applicable 180-day exclusivity determinations made by FDA on or after the date of the notice announcing the availability of this guidance (including for patent certifications that were submitted prior to the date of the notice where the exclusivity determination has not yet been made). The approach described in this guidance will remain in effect until superseded. As noted in this section I, to date, FDA's exclusivity decisions have only involved applications or amendments submitted on different days.

This guidance represents the agency's current thinking on 180-day exclusivity when multiple ANDAs are submitted on the same day. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments on the guidance at any time. Two paper copies of mailed comments are to be submitted, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The guidance and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Persons with access to the Internet may obtain the document at either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

In the Federal Register of June 12, 2002 (67 FR 40318), FDA announced the availability of the draft guidance entitled “Guidance for Industry and FDA; Implantable Middle Ear Hearing Device.” FDA invited interested persons to comment on the draft guidance by September 10, 2002. On August 16, 2002, FDA held a meeting of the Ear, Nose, and Throat Devices Panel of the Medical Devices Advisory Committee to discuss the draft guidance.

FDA received seven comments. In general, most comments suggested various clarifications throughout the document. FDA revised the document accordingly. One comment stated that the standard entitled “ANSI/IEEE C63.19-2001 American National Standard for Methods of Measurement of Compatibility Between Wireless Communications Devices and Hearing Aids” was developed for air conduction hearing aids and that the standard requires measurements that have been difficult to reproduce in these conventional hearing aids. FDA agrees, however, the agency believes that portions of this standard may be useful. Therefore, the guidance has been revised to recommend that manufacturers use test methods cited in this standard that are applicable to their device designs. There were two comments requesting a more precise definition for the “control condition” in the suggested clinical study design for IMEHDs. FDA agrees and will replace the term “state-of-the-art” with “appropriately fit conventional air conduction hearing aids.” Another comment suggested that measuring aided baseline performance is not necessary as a control condition. FDA disagrees. The agency believes that it is important to compare IMEHD performance to both appropriately fit conventional air conduction hearing aid performance and unaided performance for the benefit of clinicians and prospective IMEHD recipients.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on premarket approval applications for IMEHDs. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.

To receive “Guidance for Industry and FDA Staff; Implantable Middle Ear Hearing Device” by fax machine, 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 (1406) followed by the pound sign (#). Follow the remaining voice prompts to complete your request.

Persons interested in obtaining a copy of the guidance may also do so by using the Internet. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer. 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 guidance documents is available at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also available on the Division of Dockets Management Internet site at http://www.fda.gov/ohrms/dockets.

This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). The collections of information addressed in the guidance document have been approved by OMB in accordance with the PRA under the regulations governing premarket approval applications (21 CFR part 814, OMB control number 0910-0231). The labeling provisions addressed in the guidance 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 or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

FDAMA (Public Law 105-115) was enacted on November 21, 1997. Section 413 of FDAMA, entitled “Food and Drug Administration Study of Mercury Compounds in Drugs and Food,” required FDA to: (1) Compile a list of drugs and foods that contain intentionally introduced mercury compounds, and (2) provide a quantitative and qualitative analysis of the mercury compounds in this list. The statute did not differentiate whether the mercury compound was present in the products as an active or an inactive ingredient and required FDA to compile the list and provide the analysis within 2 years after the date of its enactment.

FDA prepared this list and announced its availability in the Federal Register of November 19, 1999 (64 FR 63323). The list is entitled “Mercury in Drug and Biologic Products” and is available on the Internet at http://www.fda.gov/cder/fdama/mercury300.htm.

Five manufacturers and distributors subsequently informed FDA that 10 products had been reformulated to delete the mercury ingredients or were no longer being marketed. However, FDA did not update the list at that time.

In the Federal Register of February 3, 2003 (68 FR 5299), FDA published a notice requesting information to update this list. FDA was aware that other manufacturers or distributors with products on the list had reformulated their products since 1999. FDA requested any affected manufacturer or distributor to inform us which product(s) on the list had been reformulated and no longer contain mercury ingredients. Eleven manufacturers provided information, which resulted in 39 additional products being deleted from the list and one product being added to the list. The new list now includes 171 products. The list continues to provide information and does not set forth any requirements.

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. A copy of the list and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

The Mandatory Guidelines were developed in accordance with Executive Order 12564 and section 503 of Pub. L. 100-71. Subpart C of the Guidelines, “Certification of Laboratories Engaged in Urine Drug Testing for Federal Agencies,” sets strict standards that laboratories must meet in order to conduct urine drug testing for Federal agencies. To become certified, an applicant laboratory must undergo three rounds of performance testing plus an on-site inspection.

To maintain that certification, a laboratory must participate in a quarterly performance testing program plus periodic, on-site inspections.

Laboratories which claim to be in the applicant stage of certification are not to be considered as meeting the minimum requirements expressed in the HHS Mandatory Guidelines. A laboratory must have its letter of certification from HHS/SAMHSA (formerly: HHS/NIDA) which attests that it has met minimum standards.

In accordance with Subpart C of the Mandatory Guidelines, the following laboratories meet the minimum standards set forth in the Mandatory Guidelines:

The following laboratory withdrew from the National Laboratory C certification Program on July 14, 2003:

Notice of the meeting is given under the Federal Advisory Committee Act, 5 U.S.C. App. 2.

Agenda: The agenda includes the following:

(1) Ratemaking Methodology Development—What are the proper factors/indicators that should be used to determine if the rate should be increased or decreased?

(2) Update on Pilot Attrition.

(3) Briefing on Maritime Security on the Great Lakes.

(4) Develop Notice for Public Input on Cost Saving Reform Strategies for Great Lakes Pilotage.

(5) Acting Director of Great Lakes Pilotage Report.

(6) Briefing on Determining Pilotage Rate by Vessel Size.

(7) Solicitation of Seventh Member.

(8) Brainstorming Session on the Use of Non-Association Pilots.

(9) Promoting Great Lakes Ports—what are the constraints to having a 12-month shipping season?

(10) Overview of Public Comments on the Bridge Hour Study.

The meeting is open to the public. Please note that the meeting may close early if all business is finished. At the Chair's discretion, members of the public may make oral presentations during the meeting. If you would like to make an oral presentation at the meeting, please notify the Executive Director no later than August 15, 2003. Written material for distribution at the meeting should reach the Coast Guard no later than August 15, 2003. If you would like a copy of your material distributed to each member of the committee in advance of the meeting, please submit 10 copies to Margie Hegy at the address in the ADDRESSES section no later than August 11, 2003.

For information on facilities or services for individuals with disabilities or to request special assistance at the meeting, contact the Executive Director as soon as possible.

While still a part of the Department of Transportation, in January 2003, the Transportation Security Administration (TSA) proposed establishing a new system of records under the Privacy Act, known as “Aviation Security Screening Records.” TSA intends to use this system of records to facilitate TSA's passenger and aviation security screening program under the Aviation and Transportation Security Act. TSA intends to use the CAPPS II system to conduct risk assessments to ensure passenger and aviation security.

Prior to March 1, TSA was an operating administration within the Department of Transportation (DOT). While part of the DOT, TSA published for public comment proposed system of records DOT/TSA 010. See 68 FR 2101 and 2002, Jan. 15, 2003. On March 1, 2003, TSA became a component of the Department of Homeland Security (DHS) and is now continuing work towards the system of records DHS/TSA 010.

Substantial comments were received in response to the prior Privacy Act notice. Those comments can be reviewed online at http://dms.dot.gov/, by entering the docket number “1437” under “Simple Search.” Significant changes have been made to date to the proposed CAPPS II system in light of these comments, and the comments and concerns raised will continue to be considered during the testing and evaluation periods. Accordingly, we are publishing an Interim Final Notice of System of Records, modified to address public comment thus far, which is effective for and applicable to the internal test activity described herein. With the publication of this notice, internal systems testing will begin, using this System of Records.

The CAPPS II system is still under consideration and development and certain elements of the technological systems are proposed for testing with attention to the issues raised in the comments received, particularly the accuracy, efficiency, and privacy impact of the proposed CAPPS II system. Results of the current technological tests, as well as the comments received, will inform the design of the final CAPPS II system. A further Privacy Act notice will be published in advance of any active implementation of the CAPPS II system for real-time passenger screening.

TSA is establishing this system of records, now entitled “Passenger and Aviation Security Screening Records,” to support the function of TSA's CAPPS II system. CAPPS II is intended to conduct risk assessments and authentications for passengers traveling by air to, from or within the United States.

Under the proposed CAPPS II system, TSA will obtain electronically, either from airlines or from Global Distribution Systems, a passenger's “passenger name record” (PNR) as collected from the passenger by a reservation system. PNR includes the routine information collected at the time a passenger makes a flight reservation. A PNR may include each passenger's full name, home address, home telephone number, and date of birth, as well as some information about that passenger's itinerary. No additional information beyond this data is required to be collected from passengers for the operation of CAPPS II.

The CAPPS II system will access PNRs prior to the departure of the passenger's flight. Selected information will be securely transmitted to commercial data providers, for the sole purpose of authenticating passenger identity. This authentication will be accomplished not by a permanent co-mingling of data, but merely by the commercial data providers transmitting back to TSA a numeric score, which is an indication of the percentage of accuracy of the match between the commercial data and the data held by TSA. This will enable TSA to have a reasonable degree of confidence that each passenger is who he or she claims to be. TSA recognizes that inaccuracies in the commercial data may exist and that the CAPPS II system must allow for and compensate for such inaccuracies; this test phase is intended to test and further develop such capabilities in the system.

Commercial data providers will receive a limited amount of identifying information from TSA with regard to each passenger, and will provide TSA with an authentication score and code indicating a confidence level in that passenger's identity. The commercial data providers will not provide TSA with any additional information about the individual. They will not acquire ownership of the data, nor will they be permitted to retain the data in any commercially usable form. TSA will not permit the commercial data providers to use this data for any purpose other than in connection with the CAPPS II program. Importantly, the commercial data provider will not retain information about the response they provide to TSA in any record about the individual that they maintain. Further, no persistent link between an individual's records in the private sector and that person's records within the CAPPS II system will be created.

Once CAPPS II has authenticated a passenger's identity, it will conduct its risk assessment. The risk assessment function is conducted internally within the U.S. government and will determine the likelihood that a passenger is a known terrorist, or has identifiable links to known terrorists or terrorist organizations. National security information from within the Federal Government, as well as information reflecting Federal officials with high levels of security clearance, will be part of this analysis function.

After the CAPPS II system becomes operational, it is contemplated that information regarding persons with outstanding state or Federal arrest warrants for crimes of violence may also be analyzed and applied in the context of this system. At or after such time as the system becomes operational, where there is an indication of a serious violation of criminal law (as described in the Routine Use section, below), such information may be shared between law enforcement agencies and the Department of Homeland Security and appropriate action may be taken. It is further anticipated that CAPPS II will be linked with the U.S. Visitor and Immigrant Status Indicator Technology (US-VISIT) program at such time as both programs become fully operational, in order that the processes at both border and airport points of entry and exit are consistent. Any such linkages will be performed in full compliance with the Privacy Act of 1974, including any applicable requirement for additional notice.

It is important to note the CAPPS II system is designed to determine the likelihood that a passenger is a known terrorist, or has identifiable links to known terrorists or terrorist organizations, including both foreign and domestic terrorist organizations.

Lastly, it is anticipated that dynamic inputs to the system from intelligence sources will allow the system to respond to current threat conditions and information on a timely basis.

Based upon the combination of information derived from commercial sources, national security sources, and dynamic intelligence data, each traveling passenger will be identified with a “risk score,” indicating whether that person's information leads to a determination of low, high, or unknown risk to passenger and aviation security.

In the vast majority of cases, passengers will be identified as “low risk,” and will simply pass through the ordinary airport security screening process to their flights.

In a small percentage of cases, passengers may be found to present an elevated, uncertain or “unknown risk” of terrorism. In such cases, the passengers in question will be subjected to heightened security screening prior to boarding their flights. Once these passengers have successfully completed this screening, they will proceed to their flights in the normal manner; they will not be penalized, nor will additional information about them be retained within the CAPPS II system.

Where a passenger is found to be “high risk”—to have identifiable links to terrorism, law enforcement or other appropriate authorities will be notified for appropriate action. It is anticipated that the number of passengers so identified as high risk will be extremely small, but any so identified may be critically significant in the context of homeland security.

The Department of Homeland Security is committed to working with airlines and the travel industry to provide greater understanding and awareness of the purposes for and the scope of CAPPS II. Consistent with fair information principles, The Department of Homeland Security will work towards adequate notice to the passenger when that passenger provides information that will be used for security purposes.

Further, DHS is committed to providing access to the information that is contained in the CAPPS II system to the greatest extent feasible consistent with national security concerns. As detailed below, passengers can request a copy of most information contained about them in the system from the CAPPS II passenger advocate. Further, DHS is currently developing a robust review and appeals process, to include the DHS privacy office.

At this point, partly in response to concerns raised by the public about the viability and function of the CAPPS II program, TSA plans to test certain portions of the system, including the technological communications between the CAPPS II system and the various data sources, as well as the identity authentication programs. These tests are intended to respond to public concerns about speed, accuracy, and efficiency of the system. Testing will be concerned with the accuracy of public and private information contained in the system, particularly in the authentication process; the speed of response of the system; identifying and minimizing the data necessary to effectively conduct the operation of CAPPS II; and the overall ability of the system to identify risk levels effectively. During these tests, TSA will use and retain PNR data for the duration of the test period. It is anticipated that the test duration may be as long as 180 days. A persistent link to law enforcement databases will not be created for the purposes of the test, nor will data from the test be transmitted to airport screeners or used for screening purposes during the test period. If, however, an indication of terrorist or potential terrorist activity is revealed during the test period, appropriate action will be taken. A final Privacy Act notice will be published before the CAPPS II system is deployed.

TSA received well over 200 comments on proposed system of records DOT/TSA 010—“Aviation Security Screening Records.” Comments generally expressed concern that the proposed CAPPS II system was too broad in scope and would prove invasive to passengers' privacy. Several commenters stated that the proposed system of records contained too wide a variety of personal information and allowed for the collection and retention of too much information on private citizens. Commenters also expressed concern about the quality of data contained in commercial databases, and that such data could be used to prevent them from traveling by air. Some commenters stated that the proposed retention of data for up to 50 years was too long. Another concern expressed was the broad variety of “routine uses,” which, in the opinion of some commenters, allowed TSA far too much discretion to disseminate private information. One commenter expressed the view that the CAPPS II system would lead to the misallocation of security resources.

TSA respects the concerns raised by commenters and has modified the proposed system of records to address many of those concerns. The test of the technological systems responds, in part, to concerns of accuracy, efficiency, and effectiveness, which are among the underpinnings of evaluating such a system's impact on an individual's privacy. Any subsequent modifications to the system that arise from the knowledge gained from these tests will be published in a subsequent notice.

This system notice reduces the extent to which TSA will maintain or disseminate personal information on airline passengers. At the same time, however, TSA must ensure that it collects information sufficient to carry out its security screening functions in an efficient and effective manner, consistent with its legislative mandate to ensure passenger and aviation security. In establishing the parameters of the Passenger and Aviation Security Screening Records system, TSA has attempted to address privacy interests of passengers and the public, while simultaneously working towards increased transportation security.

As discussed above, several commenters objected to the amount of personal information that TSA proposed to maintain in the proposed system of records. Under this system notice, TSA will not retain significant amounts of personal information after completion of a passenger's itinerary. TSA eliminated language in the proposed notice that could be read to mean that TSA will collect and maintain large amounts of information about individuals.

Concerns have been raised about the retention of data after a passenger's travel. In response, TSA is working to minimize the length of time any data about passengers will be retained. In response to concerns, the proposal to maintain information about certain individuals for up to 50 years has been deleted. Under the final CAPPS II program, when active, it is anticipated that TSA will delete all records of travel for U.S. citizens and lawful permanent resident aliens not more than a certain number of days after the safe completion of their travel itinerary. At this time, the amount of information about non-U.S. persons and the length of time for which that information will be kept when the CAPPS II system is deployed are matters still under consideration.

The limited test data used during the test period will be retained solely for the duration of the test; at the conclusion of the test, DHS expects that all data from the test will be destroyed, unless otherwise required by law. In either case, such data will not be included in the live activation of CAPPS II.

Commenters also objected to the broad description of the types of data to be collected from passengers. Specifically, commenters stated that there was no clear explanation of what TSA meant by “associated data” in the reference to TSA's collection of PNR and “associated data.” In response, TSA has deleted the phrase “associated data.”

Some commenters objected to the large variety of different types of data that TSA proposed to maintain in the system of records. TSA has significantly reduced the variety of data to be maintained in the system. For the vast majority of passengers, the CAPPS II system, when active, will maintain only the routine information that all individuals provide when making reservations, as contained in the PNR, including full name, date of birth, home address and home phone number, to the extent available. In addition, the CAPPS II system will contain authentication scores and codes, and a TSA-generated risk assessment score. The system will also contain some information derived from governmental databases containing information on, or pertinent to, the detection of terrorists and their associates and the detection of the serious criminal violations detailed in this notice, as well as information on government officials and other persons holding security clearances or positions of trust such as not to warrant heightened scrutiny. However, in response to specific concerns regarding the use of information about an individual's creditworthiness or individual health records, TSA will not use measures of creditworthiness, such as FICO scores, and individual health records in the CAPPS II traveler risk determination.

Other commenters raised concerns that large numbers of people would be prevented from flying as a result of the use of inaccurate commercial records. One of TSA's primary purposes in creating this new system is to avoid the kind of miscommunication and improper identification that has, on occasion, occurred under the systems currently in use. During the test period, TSA hopes to confirm that the use of the CAPPS II program will significantly reduce improper identification.

In response to the comments received that expressed concerns about the further dissemination of passenger information, TSA has narrowed several routine uses in the proposed notice, and eliminated others in their entirety, as follows:

Proposed Routine Use 1 (to Federal, State, local, international, or foreign agencies) (now Routine Use 1) has been narrowed to pertain to specified violations of criminal law.

Proposed Routine Use 3 (now Routine Use 3) has been modified to specify immigration and intelligence agencies.

Proposed Routine Uses 4 (to individuals and organizations), 5 (to government agencies in connection with employment, contract or benefit matters) and 6 (to news media) have been deleted.

Proposed Routine Use 2 (now Routine Use 2) and proposed Routine Use 9 (now Routine Use 4) have been modified slightly to make the language consistent with the routine uses in other TSA systems of records. These changes are not substantive and do not expand or narrow the scope of the routine uses.

Proposed Routine Use 10 (now Routine Use 5) has been modified slightly to allow for disclosures to airports and aircraft operators only to the extent required in the interests of counterterrorism or passenger or aviation security.

Proposed Routine Use 11 (now Routine Use 6) has been modified to permit disclosure to the General Services Administration (GSA), in addition to the National Archives and Records Administration (NARA), for purposes of records management inspections. Both GSA and NARA have the statutory authority under 44 U.S.C. 2904 and 2906 to conduct inspections or surveys of TSA records, which was not reflected in the proposed routine use. This modification corrects the omission.

The following applicant has requested issuance of a scientific research and enhancement of survival permit to conduct certain activities with endangered species pursuant to section 10(a)(1)(A) of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq.).

Section 4(c)(2)(A) of the Act requires that we conduct a review of listed species at least once every 5 years. We are then, under section 4(c)(2)(B) and the provisions of subsections (a) and (b), to determine, on the basis of such a review, whether or not any species should be removed from the List (delisted), or reclassified from endangered to threatened, or threatened to endangered. Our regulations at 50 CFR 424.21 require that we publish a notice in the Federal Register announcing those species currently under active review. This notice announces our active review of the delta smelt.

Conducting a 5-year review for the delta smelt at this time was agreed to in connection with the settlement of two lawsuits, California Farm Bureau Federation et al. v. U.S. Department of the Interior et al., Case No. 1:02CV02328 (D.D.C., Nov. 22, 2002) and San Luis & Delta Mendota Water Authority et al. v. U.S. Department of the Interior et al., Case No. CIV-F-02-6461 REC. D.B. (E.D. Cal., Nov. 22, 2002). The settlement agreement was signed by the DC district court on June 13, 2003, and by the federal district court in Fresno, California on June 19, 2003.

The 5-year review considers all new information available at the time of the review. This review will consider the best scientific and commercial data that has become available since the current listing determination or most recent status review, such as:

A. Species biology including, but not limited to, population trends, distribution, abundance, demographics, and genetics;

B. Habitat conditions including, but not limited to, amount, distribution, and suitability;

C. Conservation measures that have been implemented that benefit the species;

D. Threat status and trends (see five factors under heading “How do we determine whether a species is endangered or threatened?”); and

E. Other new information, data, or corrections including, but not limited to, taxonomic or nomenclatural changes, identification of erroneous information contained in the List, and improved analytical methods.

The List is found in 50 CFR 17.11 (wildlife) and 17.12 (plants). Amendments to the List through final rules are published in the Federal Register. The List is also available on our Internet site at http://endangered.fws.gov/wildlife.html#Species. In Table 1 below, we provide a summary of the listing information for the delta smelt.

The following definitions are provided to assist those persons who contemplate submitting information regarding the species being reviewed:

A. Species includes any species or subspecies of fish, wildlife, or plant, and any distinct population segment of any species of vertebrate, which interbreeds when mature.

B. Endangered means any species that is in danger of extinction throughout all or a significant portion of its range.

C. Threatened means any species that is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range.

Section 4(a)(1) of the Act establishes that we determine whether a species is endangered or threatened based on one or more of the five following factors:

A. The present or threatened destruction, modification, or curtailment of its habitat or range;

B. Overutilization for commercial, recreational, scientific, or educational purposes;

C. Disease or predation;

D. The inadequacy of existing regulatory mechanisms; or

E. Other natural or manmade factors affecting its continued existence.

Section 4(a)(1) of the Act requires that our determination be made on the basis of the best scientific and commercial data available.

If we find that there is new information concerning the delta smelt indicating a change in classification may be warranted, we may propose a new rule that could do one of the following: (a) Reclassify the species from threatened to endangered; or (b) remove the species from the List. If we determine that a change in classification is not warranted, the delta smelt will remain on the List under its current status.

If there is no new information no changes will be made to the classification of the delta smelt under this review. However, we are not limited to reviewing listed species only during a 5-year review. We may review a species at any time, and may initiate reclassification or delisting whenever the best available scientific and commercial information indicates that such action is warranted.

We request any new information concerning the status of the delta smelt. New information is considered to be scientific and commercial data that has become available since the time of the species' current listing determination. In particular, we are seeking information such as:

A. Species biology including, but not limited to, population trends, distribution, abundance, demographics, and genetics;

B. Habitat conditions including, but not limited to, amount, distribution, and suitability;

C. Conservation measures that have been implemented that benefit the species;

D. Threat status and trends (see five factors under heading “How do we determine whether a species is endangered or threatened?”); and

E. Other new information, data, or corrections including, but not limited to, taxonomic or nomenclatural changes, identification of erroneous information contained in the List, and improved analytical methods.

Information submitted should be supported by documentation such as maps, bibliographic references, methods used to gather and analyze the data, and/or copies of any pertinent publications, reports, or letters by knowledgeable sources.

A Notice of Intent to prepare an Environmental Impact Statement was published in the Federal Register on May 18, 2001. A Notice of Availability of the Draft Environmental Impact Statement (DEIS) was published in the Federal Register on March 7, 2003. In addition to the Proposed Action (the Agencies Preferred Alternative) of continuing mining along the strike of the ore while backfilling previously mined-out pits, two additional alternatives are being considered—Alternative 1 is similar to the proposed alternative, but includes impermeable capped backfilled wastes—Alternative 2 is described as the No-Action Alternative and would not allow mineral extraction to occur on the approved leases. Two additional alternatives were identified and considered in comments received on the DEIS—the first additional alternative suggested in the comments included a redesign of the partially backfilled pit bottom to allow water to drain to one end of an impermeable layer lined pit. The water collected within the pit could then be pumped to adjacent wetlands. The second alternative identified from comments in the DEIS was to mine and transport ore from Utah to supply Agrium's fertilizer plant in Idaho. The FEIS is published in an abbreviated format that responds to comments received on the DEIS.

The DEIS addresses alternatives for possible salvage opportunities and proposed restoration projects designed to move resource conditions closer to the desired future conditions identified in the Northwest Forest Plan, Elk Creek Watershed Analysis, and the South Cascades Late-Successional Reserve Assessment (LSRA). Two types of salvage, area and roadside, are discussed in Alternatives C through G. Alternatives A and B propose no salvage. Alternatives C through G were designed using specific guidance relating to post-fire salvage and/or Late-Successional Reserve guidelines. Research could be incorporated within each of the salvage alternatives. Included in the design of Alternative G is a study of the effects of various snag retention levels on wildlife species. Roadside salvage is designed to reduce existing or potential public safety concerns while recovering economic value of these dead trees.

Four levels of restoration projects are proposed in the six action alternatives: Focused, moderate, extensive, and focused within the fire perimeter only. The restoration varies by the scope of the projects (acres, miles of roads, etc.), intensity of the treatments, and location of the treatments. Restoration projects are located both within the Timbered Rock Fire perimeter and outside the fire area. Most projects are located within the Elk Creek Watershed; however, a proposed eagle nest project and some fuel management zone projects are located on ridge tops within adjacent watersheds. Projects are based on recommendations presented in the Late-Successional Reserve Assessment and/or Elk Creek Watershed Analysis, or were developed to address specific issues.

Projects proposed within the fire area focus on road projects to reduce existing and potential sedimentation from the road network, fish improvement projects, development of Fuel Management Zones, and reducing future hazardous fuel conditions within existing Northern Spotted Owl activity centers. Reforestation of the burned area was assessed in the Emergency Stabilization/Rehabilitation Plan Environmental Assessment. Alternatives A and E follow these recommendations. Other approaches to reforestation are presented in Alternatives B, C, D, F, and G. A reforestation study is included which would evaluate a variety of planting densities, species, and follow-up treatments in both salvage and unsalvaged areas. This reforestation research could be incorporated into any alternative.

Alternative A (No Action, Continuation of current management) follows the Emergency Stabilization/Rehabilitation Plan as planned for the Timbered Rock Fire. No restoration projects are proposed, but rehabilitation and stabilization projects proposed in the Timbered Rock Fire Rehabilitation/Stabilization Project Environmental Assessment would be implemented.

Emphasis of Alternative B (No Salvage and Focused Restoration Emphasis) is placed on reducing non-commercial size vegetative competition in over-stocked stands with density management treatments, fuels reduction treatments, and pine habitat restoration. Areas proposed for treatment are generally those in most need of reducing competing vegetation. Within the fire perimeter, restoration would focus on high priority road work. Restoration actions would focus on non-commercial projects, designed to accelerate the growth of trees in stands to promote late-successional conditions with a variety of size classes. Species diversity would be maintained to promote connectivity between owl activity sites and develop late-successional forest characteristics.

In Alternative C (Salvage Following South Cascade Late-Successional Reserve Assessment Guidelines and Moderate Restoration Emphasis), area salvage emphasis is proposed in high and moderate burn severity areas greater than 10 acres where the fire resulted in a stand-replacement event. Alternative C salvage is based on guidelines from the Late-Successional Reserve Assessment for snag and coarse woody debris retention. Restoration projects include fish habitat improvement, Late-Successional Reserve thinning, pine and oak woodlands restoration, reforestation of stand-replacement areas greater than 5 acres, fuels reduction along ridgelines, wildlife habitat enhancement projects, and road improvement projects.

In Alternative D (Late-Successional Reserve Guidelines for Salvage Using DecAID Wood Advisor Tool for Snags and Coarse Woody Debris (CWD) and Moderate Restoration Emphasis), area salvage emphasis is proposed in high and moderate burn severity areas greater than 10 acres where the fire resulted in a stand-replacement event. Instead of following LSRA salvage guidelines, snag and coarse woody debris retention levels in this alternative are based on the DecAID Wood Advisor tool. Restoration projects would be the same as Alternative C.

In Alternative E (High Level of Salvage and Extensive Restoration Emphasis), area salvage emphasis is proposed in high, moderate, low and very low burned severity areas. Snag retention levels within the high and moderate burn severity areas would be 6-14 snags/acre. This is based on study by Haggard and Gaines (2001) which found the highest diversity in cavity nesting species and the highest number of nests where snag densities ranged from 6-14 snags/acre. Snag retention within the low and very low burn severity areas with canopy cover greater than 40 percent would be 4 snags/acre. The course woody debris level in this alternative would be a minimum of 120 linear feet/acre. Extensive restoration would increase the scope of the projects (acres, miles of roads, etc.), intensity of the treatments, and location of the treatments identified in Alternative C and D. Alternative E also proposes seasonal closure of some roads.

In Alternative F (Salvage Logging and Post-fire rehabilitation actions consistent with report on Recommendations for Ecologically Sound Post-Fire Salvage Management and Other Post-Fire Treatments on Federal Lands in the West (Beschta et al., 1995)), area salvage emphasis is based on recommendations to avoid severely burned areas, erosive sites, fragile soils, riparian areas, steep slopes, or sites where accelerated erosion is possible. Existing snags and course woody debris levels would be retained on all these areas. Salvage would occur in 3-10 acre patches of fire-killed trees. Within each of these patches, a minimum of 2 acres would be reserved from salvage. The Beschta et al. report does not address actions outside of a burned area. As a result, no Late-Successional Reserve restoration actions are proposed. However, restoration projects within the fire perimeter, consistent with Beschta et al. report are proposed.

In Alternative G (Preferred Alternative—Salvage Including Research and Moderate Restoration Emphasis), area salvage emphasis is based on research to study the effects of various snag levels on selected wildlife species. Sixteen units were selected to be included in this study. These units are generally 30 acres or greater and would be salvaged at various levels. In addition, four control units would not be salvaged. Stand replacement areas (high and moderate burn severity) outside of research units greater than 10 acres would also be considered for salvaging. Snag and course woody debris levels would meet DecAid Wood Advisor recommendations, as well as, other local and regional recommendations. A reforestation study is also included, which would evaluate a variety of planting densities, species, and follow-up treatments in both salvaged and unsalvaged areas. Restoration projects would be the same as Alternatives C and D. Alternative G also proposes seasonal closure of some roads.

It is not the intent of this project to change land use allocations, nor Standard and Guidelines made through the Northwest Forest Plan and later adopted through the Medford District Resource Management Plan. The Preferred Alternative has been determined to be consistent with the Northwest Forest Plan and Medford District Resource Management Plan. However, if alternative E or F is selected as the Preferred Alternative in the Final EIS, a plan amendment may be required.

The members of the councils advise the Secretary of the Interior, through the BLM, on a variety of planning and management issues associated with public land management in California. At these meetings, the major agenda topics will be the Sustaining Working Landscapes initiative in which the Bureau is considering new management approaches intended to promote better partnerships with grazing permittees, advance the long-term health and productivity of the public lands, provide for sustainable ranching and improve BLM's business practices. The councils will discuss the initiative and receive public comments. All meetings are open to the public. Members of the public may present written comments to the council. Each formal council meeting will have time allocated for public comments. Depending on the number of persons wishing to speak, and the time available, the time for individual comments may be limited. Individuals who plan to attend and need special assistance, such as sign language interpretation and other reasonable accommodations, should contact the BLM as provided above.

The Office of Management and Budget (OMB) regulations at 5 CFR regulations at 5 CFR 1320, which implement provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13), require that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities (see 5 CFR 1320.8 (d)). This notice identifies information collections that OSM will be submitting to OMB for extension. These collections are contained in 30 CFR part 773 (Requirements for permits and permit processing), part 774 (Revision; Renewal; and Transfer, Assignment, or Sale of Permit Rights), and part 778 (Permit Applications—Minimum Requirements for Legal, Financial, Compliance, and Related Information).

OSM has revised burden estimates, where appropriate, to reflect current reporting levels or adjustments based on reestimates of burden or respondents. OSM will request a 3-year term of approval for each information collection activity.

Comments are invited on: (1) The need for the collection of information for the performance of the functions of the agency; (2) the accuracy of the agency's burden estimates; (3) ways to enhance the quality, utility and clarity of the information collection; and (4) ways to minimize the information collection burden on respondents, such as use of automated means of collection of the information. A summary of the public comments will be included in OSM's submissions of the information collection requests to OMB.

The following information is provided for each information collection: (1) Title of the information collection; (2) OMB control number; (3) summary of the information collection activity; and (4) frequency of collection, description of the respondents, estimated total annual responses, and the total annual reporting and recordkeeping burden for the collection of information.

Title: Requirements for Permits and Permit Processing, 30 CFR 773.

OMB Control Number; 1029-0115.

Summary: The collection activities for this part ensure that the public has the opportunity to review permit applications prior to their approval, and that applicants for permanent program permits or their associates who are in violation of the Surface Mining Control and Reclamation Act do not receive surface coal mining permits pending resolution of their violations.

Bureau Form Number: None.

Frequency of Collection: Once.

Description of Respondents: Applicants for surface coal mining and reclamation permits and State governments and Indian Tribes.

Total Annual Responses: 324.

Total Annual Burden Hours: 11,058.

Title: Revisions; Renewals; and Transfer, Assignment, or Sale of Permit Rights—30 CFR 774.

OMB Control Number; 1029-0116.

Summary: Sections 506 and 511 of Public Law 95-87 provide that persons seeking permit revisions, renewals, transfer, assignment, or sale of their permit rights for coal mining activities submit relevant information to the regulatory authority to allow the regulatory authority to determine whether the applicant meets the requirements for the action anticipated.

Bureau Form Number: None.

Frequency of Collection: On occasion.

Description of Respondents: Surface coal mining permit applicants and State regulatory authorities.

Total Annual Responses: 6,498.

Total Annual Burden Hours: 49,164.

Title: Permit Applications—Minimum Requirements for Legal, Financial, Compliance, and Related Information—30 CFR 778.

OMB Control Number: 1029-0117.

Summary: Section 507(b) of Public Law 95-87 provides that persons conducting coal mining activities submit to the regulatory authority all relevant information regarding ownership and control of the property affected, their compliance status and history. This information is used to insure all legal, financial and compliance requirements are satisfied prior to issuance or denial of a permit.

Bureau Form Number: None.

Frequency of Collection: Once.

Description of Respondents: Surface coal mining permit applicants and State regulatory authorities.

Total Annual Responses: 301.

Total Annual Burden Hours: 6,436.

The Commission instituted this investigation on February 26, 2003, based on a complaint filed by Speedline Technologies, Inc. (“Speedline”) against EKRA America, Inc., and EKRA Eduard Kraft GmbH (collectively, “EKRA”). The complaint alleged violations of section 337 of the Tariff Act of 1930 in the importation into the United States, sale for importation, and/or sale within the United States after importation of certain screen printing machines, vision alignment devices used therein, and component parts thereof by reason of infringement of claims 1, 2, 3, 4, and 18 of U.S. Patent No. 5,060,063. 68 FR 8924 (Feb. 26, 2003).

On June 27, 2003, complainant Speedline and respondents EKRA filed a joint motion to terminate the investigation based upon a settlement agreement. On July 9, 2003, the Commission investigative attorney filed a response supporting the joint motion. On July 10, 2003, the presiding ALJ issued an ID (Order No. 10) granting the joint motion. No party petitioned for review of the ID.

This action is taken under the authority of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) and § 210.42 of the Commission's rules of practice and procedure (19 CFR 210.42).

Background.—On September 15, 1998, the Department of Commerce issued a countervailing duty order on imports of stainless steel wire rod from Italy (63 FR 49334-49335) and antidumping duty orders on imports of stainless steel wire rod from Italy, Japan, Korea, Spain, Sweden, and Taiwan (63 F.R. 49327-49334). The Commission is conducting reviews to determine whether revocation of the orders would be likely to lead to continuation or recurrence of material injury to the domestic industry within a reasonably foreseeable time. It will assess the adequacy of interested party responses to this notice of institution to determine whether to conduct full or expedited reviews. The Commission's determinations in any expedited reviews will be based on the facts available, which may include information provided in response to this notice.

Definitions.—The following definitions apply to these reviews:

(1) Subject Merchandise is the class or kind of merchandise that is within the scope of the five-year reviews, as defined by the Department of Commerce.

(2) The Subject Countries in these reviews are Italy, Japan, Korea, Spain, Sweden, and Taiwan.

(3) The Domestic Like Product is the domestically produced product or products which are like, or in the absence of like, most similar in characteristics and uses with, the Subject Merchandise. In its original determinations, the Commission found one Domestic Like Product consisting of all stainless steel wire rod corresponding to the scope of Commerce's investigations.

(4) The Domestic Industry is the U.S. producers as a whole of the Domestic Like Product, or those producers whose collective output of the Domestic Like Product constitutes a major proportion of the total domestic production of the product. In its original determinations, the Commission defined the Domestic Industry as consisting of all domestic producers of stainless steel wire rod.

(5) The Order Date is the date that the countervailing and antidumping duty orders under review became effective. In these reviews, the Order Date is September 15, 1998.

(6) An Importer is any person or firm engaged, either directly or through a parent company or subsidiary, in importing the Subject Merchandise into the United States from a foreign manufacturer or through its selling agent.

Participation in the reviews 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 reviews as parties must file an entry of appearance with the Secretary to the Commission, as provided in section 201.11(b)(4) of the Commission's rules, no later than 21 days after publication of this notice in the Federal Register. The Secretary will maintain a public service list containing the names and addresses of all persons, or their representatives, who are parties to the reviews.

Former Commission employees who are seeking to appear in Commission five-year reviews are reminded that they are required, pursuant to 19 CFR 201.15, to seek Commission approval if the matter in which they are seeking to appear was pending in any manner or form during their Commission employment. The Commission's designated agency ethics official has advised that a five-year review is the “same particular matter” as the underlying original investigation for purposes of 19 CFR 201.15 and 18 U.S.C. 207, the post employment statute for Federal employees. Former employees may seek informal advice from Commission ethics officials with respect to this and the related issue of whether the employee's participation was “personal and substantial.” However, any informal consultation will not relieve former employees of the obligation to seek approval to appear from the Commission under its rule 201.15. For ethics advice, contact Carol McCue Verratti, Deputy Agency Ethics Official, at 202-205-3088.

Limited disclosure of business proprietary information (BPI) under an administrative protective order (APO) and APO service list.—Pursuant to section 207.7(a) of the Commission's rules, the Secretary will make BPI submitted in these reviews available to authorized applicants under the APO issued in the reviews, provided that the application is made no later than 21 days after publication of this notice in the Federal Register. Authorized applicants must represent interested parties, as defined in 19 U.S.C. 1677(9), who are parties to the reviews. A separate service list will be maintained by the Secretary for those parties authorized to receive BPI under the APO.

Certification.—Pursuant to section 207.3 of the Commission's rules, any person submitting information to the Commission in connection with these reviews must certify that the information is accurate and complete to the best of the submitter's knowledge. In making the certification, the submitter will be deemed to consent, unless otherwise specified, for the Commission, its employees, and contract personnel to use the information provided in any other reviews or investigations of the same or comparable products which the Commission conducts under Title VII of the Act, or in internal audits and investigations relating to the programs and operations of the Commission pursuant to 5 U.S.C. Appendix 3.

Written submissions.—Pursuant to section 207.61 of the Commission's rules, each interested party response to this notice must provide the information specified below. The deadline for filing such responses is September 22, 2003. Pursuant to section 207.62(b) of the Commission's rules, eligible parties (as specified in Commission rule 207.62(b)(1)) may also file comments concerning the adequacy of responses to the notice of institution and whether the Commission should conduct expedited or full reviews. The deadline for filing such comments is October 14, 2003. All written submissions must conform with the provisions of sections 201.8 and 207.3 of the Commission's rules and any submissions that contain BPI must also conform with the requirements of sections 201.6 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). Also, in accordance with sections 201.16(c) and 207.3 of the Commission's rules, each document filed by a party to the reviews must be served on all other parties to the reviews (as identified by either the public or APO service list as appropriate), and a certificate of service must accompany the document (if you are not a party to the reviews you do not need to serve your response).

Inability to provide requested information.—Pursuant to section 207.61(c) of the Commission's rules, any interested party that cannot furnish the information requested by this notice in the requested form and manner shall notify the Commission at the earliest possible time, provide a full explanation of why it cannot provide the requested information, and indicate alternative forms in which it can provide equivalent information. If an interested party does not provide this notification (or the Commission finds the explanation provided in the notification inadequate) and fails to provide a complete response to this notice, the Commission may take an adverse inference against the party pursuant to section 776(b) of the Act in making its determinations in the reviews.

Information to be Provided in Response to this Notice of Institution: If you are a domestic producer, union/worker group, or trade/business association; import/export Subject Merchandise from more than one Subject Country; or produce Subject Merchandise in more than one Subject Country, you may file a single response. If you do so, please ensure that your response to each question includes the information requested for each pertinent Subject Country. As used below, the term “firm” includes any related firms.

(1) The name and address of your firm or entity (including World Wide Web address if available) and name, telephone number, fax number, and E-mail address of the certifying official.

(2) A statement indicating whether your firm/entity is a U.S. producer of the Domestic Like Product, a U.S. union or worker group, a U.S. importer of the Subject Merchandise, a foreign producer or exporter of the Subject Merchandise, a U.S. or foreign trade or business association, or another interested party (including an explanation). If you are a union/worker group or trade/business association, identify the firms in which your workers are employed or which are members of your association.

(3) A statement indicating whether your firm/entity is willing to participate in these reviews by providing information requested by the Commission.

(4) A statement of the likely effects of the revocation of the countervailing and antidumping duty orders on the Domestic Industry in general and/or your firm/entity specifically. In your response, please discuss the various factors specified in section 752(a) of the Act (19 U.S.C. 1675a(a)) including the likely volume of subject imports, likely price effects of subject imports, and likely impact of imports of Subject Merchandise on the Domestic Industry.

(5) A list of all known and currently operating U.S. producers of the Domestic Like Product. Identify any known related parties and the nature of the relationship as defined in section 771(4)(B) of the Act (19 U.S.C. 1677(4)(B)).

(6) A list of all known and currently operating U.S. importers of the Subject Merchandise and producers of the Subject Merchandise in the Subject Countries that currently export or have exported Subject Merchandise to the United States or other countries since 1997.

(7) If you are a U.S. producer of the Domestic Like Product, provide the following information on your firm's operations on that product during calendar year 2002 (report quantity data in short tons and value data in U.S. dollars, f.o.b. plant). If you are a union/worker group or trade/business association, provide the information, on an aggregate basis, for the firms in which your workers are employed/which are members of your association.

(a) Production (quantity) and, if known, an estimate of the percentage of total U.S. production of the Domestic Like Product accounted for by your firm's(s') production;

(b) The quantity and value of U.S. commercial shipments of the Domestic Like Product produced in your U.S. plant(s); and

(c) The quantity and value of U.S. internal consumption/company transfers of the Domestic Like Product produced in your U.S. plant(s).

(8) If you are a U.S. importer or a trade/business association of U.S. importers of the Subject Merchandise from the Subject Countries, provide the following information on your firm's(s') operations on that product during calendar year 2002 (report quantity data in short tons and value data in U.S. dollars). If you are a trade/business association, provide the information, on an aggregate basis, for the firms which are members of your association.

(a) The quantity and value (landed, duty-paid but not including antidumping or countervailing duties) of U.S. imports and, if known, an estimate of the percentage of total U.S. imports of Subject Merchandise from each of the Subject Countries accounted for by your firm's(s') imports;

(b) The quantity and value (f.o.b. U.S. port, including antidumping and/or countervailing duties) of U.S. commercial shipments of Subject Merchandise imported from each of the Subject Countries; and

(c) The quantity and value (f.o.b. U.S. port, including antidumping and/or countervailing duties) of U.S. internal consumption/company transfers of Subject Merchandise imported from each of the Subject Countries.

(9) If you are a producer, an exporter, or a trade/business association of producers or exporters of the Subject Merchandise in the Subject Countries, provide the following information on your firm's(s') operations on that product during calendar year 2002 (report quantity data in short tons and value data in U.S. dollars, landed and duty-paid at the U.S. port but not including antidumping or countervailing duties). If you are a trade/business association, provide the information, on an aggregate basis, for the firms which are members of your association.

(a) Production (quantity) and, if known, an estimate of the percentage of total production of Subject Merchandise in each of the Subject Countries accounted for by your firm's(s') production; and

(b) The quantity and value of your firm's(s') exports to the United States of Subject Merchandise and, if known, an estimate of the percentage of total exports to the United States of Subject Merchandise from each of the Subject Countries accounted for by your firm's(s') exports.

(10) Identify significant changes, if any, in the supply and demand conditions or business cycle for the Domestic Like Product that have occurred in the United States or in the market for the Subject Merchandise in the Subject Countries since the Order Date, and significant changes, if any, that are likely to occur within a reasonably foreseeable time. Supply conditions to consider include technology; production methods; development efforts; ability to increase production (including the shift of production facilities used for other products and the use, cost, or availability of major inputs into production); and factors related to the ability to shift supply among different national markets (including barriers to importation in foreign markets or changes in market demand abroad). Demand conditions to consider include end uses and applications; the existence and availability of substitute products; and the level of competition among the Domestic Like Product produced in the United States, Subject Merchandise produced in the Subject Countries, and such merchandise from other countries.

(11) (Optional) A statement of whether you agree with the above definitions of the Domestic Like Product and Domestic Industry; if you disagree with either or both of these definitions, please explain why and provide alternative definitions.

The Commission instituted this investigation by notice published in the Federal Register on December 27, 2002, in response to a complaint filed on behalf of Allen-Pal, LLC of San Jose and Los Gatos, California. 67 FR 79,148 (2002). The complaint, as supplemented, alleged violations of section 337 in the importation into the United States and the sale within the United States after importation of certain tool handles, tool holders, tool sets, and components therefor by reason of infringement of claims 1, 2, 11, 12, 23, 24, 28, 29, and 30 of U.S. Patent No. 5,911,799 (“the '799 patent”) and claims 1, 14, 18, 19, 34, 37, 40, and 41 of U.S. Patent No. 6,311,587 (“the '587 patent”). Id. The Commission named two respondents, Danaher Corporation of Washington, DC, and Danaher Tool Group of Hunt Valley, Maryland (collectively, “Danaher”).

On April 22, 2003, the ALJ issued an ID (Order No. 7) terminating the investigation with respect to claims 2, 28, 29, and 30 of the '799 patent and with respect to claim 18 of the '587 patent. On April 24, 2003, the ALJ issued an ID (Order No. 8) amending the complaint and notice of investigation to add as respondents Hi-Five Products Developing Company of Taichung, Taiwan (“Hi-Five”), and Bobby Hu, of Taichung, Taiwan. Those IDs were not reviewed by the Commission.

On May 27, 2003, the Commission investigative attorney (“IA”) moved, pursuant to Commission rule 210.15(a), for a summary determination of no violation based upon non-infringement of asserted claims 1, 11, 12, 23, and 24 of the '799 patent and asserted claims 1, 14, 19, 34, 37, 40, and 41 of the '587 patent, the only claims remaining in issue, by the accused tool handles, tool holders, and tool sets imported into and sold in the United States by Danaher. The IA noted that these are the same products that respondents Hi-Five and Hu are accused of selling.

On June 10, 2003, complainant and Danaher filed a joint motion pursuant to Commission rule 210.21(a) and (b) to terminate Danaher as a respondent on the basis of a settlement agreement. On June 11, 2003, Danaher filed a response stating that it would not submit a substantive response to the IA's motion for summary determination in light of the pending joint motion for termination of the investigation based on a settlement agreement. On June 11, 2003, complainant filed its opposition to the IA's motion for summary determination. On June 13, 2003, the IA filed a motion for leave to reply to complainant's opposition with attached reply. On June 18, 2003, complainant filed a reply opposition.

On June 20, 2003, the ALJ issued an ID (Order No. 14) granting the IA's motion for summary determination and terminating the investigation. The ID found no violation of section 337 by reason of no infringement by any respondent of any of the 12 patent claims remaining in issue in the investigation. The ALJ noted that the June 10, 2003, joint motion for termination was pending before him. ID at 1 n.2. On June 26, 2003, complainant filed a motion for extension of time to file a petition for review of the ID. On June 27, 2003, the Chairman granted the motion and extended complainant's deadline for filing a petition for review until July 3, 2003. On July 2, 2003, the Commission extended the deadline for determining whether to review the ID until Wednesday, August 13, 2003. No petitions for review of the ID were filed.

This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in section 210.42 of the Commission's rules of practice and Procedure (19 CFR 210.42).

The following is a temporary order and a summary of the application. The complete application may be obtained for a fee at the Commission's Public Reference Branch, 450 Fifth Street, NW., Washington, DC 20549-0102 (telephone 202-942-8090).

1. JPMC is a holding company that, through its subsidiaries and affiliates, provides investment, financing, advisory, banking and related products and services on a global basis. JPMC is the ultimate parent company of the Applicants, each of which is an investment adviser registered under the Investment Advisers Act of 1940. Each Applicant serves as investment adviser or sub-adviser to certain registered investment companies (“Funds”).

2. On July 28, 2003, the United States District Court for the Southern District of Texas entered the Injunction against JPMC in a matter brought by the Commission.2 The Commission alleged in the complaint (“Complaint”) that JPMC aided and abetted violations of section 10(b) of the Securities Exchange Act of 1934 and rule 10b-5 thereunder by Enron Corp. (“Enron”). The alleged violations occurred in connection with Enron's financial statement disclosure of transactions with one or more affiliates of JPMC between 1997 and 2001. Without admitting or denying any of the allegations in the Complaint, except as to jurisdiction, JPMC consented to the entry of the Injunction as well as the payment of disgorgement, civil penalties and interest.

1. Section 9(a)(2) of the Act, in relevant part, prohibits a person who has been enjoined from engaging in or continuing any conduct or practice in connection with the purchase or sale of a security from acting, among other things, as an investment adviser or depositor of any registered investment company or a principal underwriter for any registered open-end investment company, registered unit investment trust or registered face-amount certificate company. Section 9(a)(3) of the Act makes the prohibition in section 9(a)(2) applicable to a company, any affiliated person of which has been disqualified under the provisions of section 9(a)(2). Section 2(a)(3) of the Act defines “affiliated person” to include any person directly or indirectly controlling, controlled by, or under common control with, the other person. Applicants state that JPMC is an affiliated person of each of the Applicants within the meaning of section 2(a)(3) of the Act. Applicants state that, as a result of the Injunction, they would be subject to the prohibitions of section 9(a).

2. Section 9(c) of the Act provides that the Commission shall grant an application for exemption from the disqualification provisions of section 9(a) if it is established that these provisions, as applied to Applicants, are unduly or disproportionately severe or that Applicants' conduct has been such as not to make it against the public interest or the protection of investors to grant the application. Applicants have filed an application pursuant to section 9(c) seeking a temporary and permanent order exempting them from the disqualification provisions of section 9(a) of the Act.

3. Applicants believe they meet the standards for exemption specified in section 9(c). Applicants state that the prohibitions of section 9(a) as applied to them would be unduly and disproportionately severe and that the conduct of Applicants has been such as not to make it against the public interest or the protection of investors to grant the exemption from section 9(a).

4. Applicants state that none of their current or former officers or employees who are engaged in the provision of investment advisory services to the Funds participated in any way in the conduct underlying the Injunction. Certain Funds held securities issued by Enron at the time of the conduct underlying the Injunction. Applicants state that as far as they are aware, none of the officers, portfolio managers or any other investment personnel employed by Applicants had any knowledge of any non-public information relating to, or had any involvement in, the conduct underlying the Injunction. Applicants further state that they had, and continue to have, policies and procedures in place designed to prohibit or restrict communications with other JPMC employees.

5. Applicants state that the inability to continue providing advisory services to the Funds would result in potentially severe hardships for the Funds and their shareholders. Applicants also state that they have distributed, or will distribute as soon as reasonably practical, written materials, including an offer to meet in person to discuss the materials, to the boards of directors or trustees of the Funds (the “Boards”), including the directors who are “interested persons,” as defined in section 2(a)(19) of the Act, of such Funds and their independent legal counsel as defined in rule 0-1(a)(6) under the Act, if any, regarding the Injunction, any impact on the Funds and the application. Applicants will provide the Boards with all information concerning the Injunction and the application that is necessary for the Funds to fulfill their disclosure and other obligations under the federal securities laws.

6. Applicants also assert that, if they were barred from providing services to the Funds, the effect on their businesses and employees would be severe. Applicants state that they have committed substantial resources to establish an expertise in advising and subadvising Funds. Applicants state that they have not received any orders under section 9(c) of the Act in the past. Applicants recently applied for an exemption pursuant to section 9(c) of the Act for conduct relating to certain research analysts' conflicts of interest.3

Applicants agree that any order granting the requested relief will be subject to the following condition:

Any temporary exemption granted pursuant to the application shall be without prejudice to, and shall not limit the Commission's rights in any manner with respect to, any Commission investigation of, or administrative proceedings involving or against, Applicants, including without limitation, the consideration by the Commission of a permanent exemption from section 9(a) of the Act requested pursuant to the application or the revocation or removal of any temporary exemptions granted under the Act in connection with the application.

The Commission has considered the matter and finds that Applicants have made the necessary showing to justify granting a temporary exemption.

Accordingly, It is hereby ordered, pursuant to section 9(c) of the Act, that Covered Persons are granted a temporary exemption from the provisions of section 9(a), effective forthwith, solely with respect to the Injunction, subject to the condition in the application, until the date the Commission takes final action on an application for a permanent order.