Title: Brucellosis Eradication Program.

OMB Number: 0579-0047.

Type of Request: Reinstatement of an information collection.

Abstract: The Animal and Plant Health Inspection Service (APHIS) is responsible for, among other things, administering regulations intended to prevent the spread of brucellosis and other animal diseases within the United States.

Brucellosis is a contagious disease that primarily affects cattle, bison, and swine. It causes the loss of young through spontaneous abortion or birth of weak offspring, reduced milk production, and infertility. The continued presence of brucellosis in a herd seriously threatens the health of other animals. Brucellosis has caused devastating losses to farmers in the United States over the last century.

The State-Federal Brucellosis Eradication Program, which is a national program, is working toward eliminating this serious disease of livestock. The program is conducted under the various States' authorities supplemented by Federal authorities regulating interstate movement of affected animals. Effective screening programs and extensive epidemiologic investigations are required to locate infection and to eradicate the disease.

Conducting effective brucellosis screening programs and epidemiologic investigations requires the use of many information collection activities, such as applications for tags or tattoos, epidemiology report forms, permits for movement of restricted animals, monthly reports of brucellosis eradication and program surveillance activities, reports of brucellosis reactors slaughtered, and permits for shipping exposed herds. The information obtained from these activities is used to continue the search for other infected herds, maintain identification of livestock, monitor deficiencies in identification of animals for movement, and monitor program deficiencies in suspicious and infected herds. These information collection activities are essential in determining the status of a brucellosis area and helping herd owners by speeding up the detection and elimination of serious disease conditions in their herds.

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

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

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

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

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

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

Estimate of burden: The public reporting burden for this collection of information is estimated to average 0.0076513 hours per response.

Respondents: Veterinarians, livestock inspectors, and herd owners.

Estimated annual number of respondents: 7,382.

Estimated annual number of responses per respondent: 71.455703.

Estimated annual number of responses: 527,486.

Estimated total annual burden on respondents: 4,036 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the average reporting burden per response.)

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

The regulations in 7 CFR part 340 (referred to as the regulations) regulate the introduction (importation, interstate movement, and release into the environment) of genetically engineered organisms and products that are plant pests or that there is reason to believe are plant pests (regulated articles). A permit must be obtained or a notification acknowledged before a regulated article may be introduced into the United States. The regulations set forth the permit application requirements and the notification procedures for the importation, interstate movement, and release into the environment of a regulated article.

On January 29, 2001, the Animal and Plant Health Inspection Service (APHIS) received a permit application (APHIS No. 01-029-01r) from APHIS' Plant Protection Center in Phoenix, AZ, for a permit to field test the plant pest pink bollworm (PBW), Pectinophora gossypiella (Lepidoptera: Gelechiidae).

APHIS published a notice in the Federal Register on June 21, 2001 (66 FR 33226, Docket No. 01-024-1), announcing the availability for public comment of an environmental assessment (EA) for the proposed confined field test of the genetically engineered PBW. Comments were to have been received by APHIS on or before July 23, 2001. APHIS received nine comments on the EA during the designated comment period. The comments were from universities, environmental and consumer groups, a university medical research center, a crop protection association, a cotton industry organization, and a cotton growers group. Four comments were in favor of the proposed field test, while three were opposed. (We counted as a single comment three separate comments critical of the proposed field test that were written by the same commenter and were identical in content.) The commenters favoring the field test stressed the thoroughness of the control and containment measures proposed, the negligible risks of the experiment because of the planned safeguards, the adequacy of the EA, and the need for gathering data on PBW control. The commenters who opposed the proposed field test expressed concern about the need for additional data on transgene stability, the need for an independent assessment of the permit application, the adequacy of the proposed containment procedures, potential human health risks, and alleged deficiencies in APHIS' compliance with the requirements of the Endangered Species Act and the National Environmental Policy Act (NEPA), including the need for an Environmental Impact Statement (EIS) for a transgenic PBW sterile insect technique program. APHIS identified and addressed the majority of these issues in the EA prepared for the subject field trial, and we have provided a response to comments as an attachment to our finding of no significant impact (FONSI), which is available from the person listed under FOR FURTHER INFORMATION CONTACT. With regard to the comment concerning the need for an EIS, APHIS is committed to considering the long-term issues associated with the release of certain transgenic arthropods through the NEPA EIS process.

The subject PBW has been genetically engineered to express an enhanced green fluorescent protein (EGFP) derived from a jellyfish, Aequora victoria. The PBW expresses EGFP fluoresces when viewed under an ultraviolet light source. A piggyBac transposable element derived from the plant pest cabbage looper ( Trichoplusia ni ) was used to transform the subject PBW, and expression of the EGFP is controlled through use of the Drosophila melanogaster hsp70 and Bombyx mori actin A3 promoters. The subject transgenic PBW is considered a regulated article under the regulations in 7 CFR part 340 because the recipient organism is a plant pest and because it contains gene sequences from a plant pest. The field test will be conducted under carefully controlled and confined conditions.

The transgenic PBW with EGFP as a marker has been developed for use in confined, on-site experimentation and field performance studies in the PBW sterile insect program, which is designed to depress PBW populations. The transgenic PBW will be reared in the Phoenix PBW insect-rearing facility, sterilized with radiation, and placed in escape-proof screen field cages near the facility, where they will undergo a series of fitness and related tests.

An EA was prepared to examine any potential environmental impacts and plant pest risk associated with the confined field testing of the transgenic EGFP PBW. Based on that EA, APHIS has reached a FONSI relative to the issuance of a permit for the confined field testing of the subject PBW with EGFP. In summary, we have based our FONSI on the following conclusions: (1) The possibility of the genetically engineered organism reverting to or undergoing unanticipated genetic transformation is exceedingly low; (2) it is highly unlikely that the EGFP gene would persist in the environment because it provides no fitness advantage to the PBW; (3) multiple levels of physical and biological confinement in the proposed research are designed to contain the transgenic PBW; (4) the PBW is not native to the United States and there are no known sexually compatible species in North America; (5) there is no current evidence that this gene can be transferred through predation, natural decay, or parasitism; (6) the confined research would not result in an additional pesticide load on the environment; (7) the research will not disproportionately affect minority or low income populations, or disproportionately affect children, or result in any environmental health risks or safety risks to children; and (8) APHIS has determined that, based on the location of the test field and the measures designed to contain the transgenic PBW, the proposed test will have no effect on listed, threatened, endangered, or candidate species.

The EA and FONSI were prepared in accordance with: (1) NEPA, as amended(42 U.S.C. 4321 et seq. ), (2) regulations of the Council on Environmental Quality for implementing the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA Implementing Procedures (7 CFR part 372).

The Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture is responsible for administering regulations to prevent the introduction of communicable diseases of livestock and poultry into the United States. In administering the regulations, we follow an import process that includes, among other things, developing an import protocol between the exporting and importing countries or regions, monitoring the disease status of countries or regions, quarantining and testing imported animals, and evaluating the risk of introducing disease into the United States through the importation of animals.

APHIS seeks to establish the import protocols between the exporting and importing countries or regions based upon the best available technical and scientific information. The protocols establish health requirements, including the disease status of the region or country of origin and diagnostic test requirements for specific diseases, under which importation of animals is allowed.

To provide a forum to discuss the process and science used to establish and verify compliance with protocols for importing cattle into the United States, APHIS' Veterinary Services program is holding a public meeting on Wednesday, February 6, 2002, in the Columbine Room at the Lincoln Center, 417 West Magnolia, Fort Collins, CO. Topics discussed at the meeting will include, but are not limited to, the disease status of exporting regions or countries, transportation issues, quarantine issues, and the risk of the introduction of disease into the United States from the importation of cattle.

The public meeting will begin at 9 a.m. and is scheduled to end at 5 p.m., with registration from 8:30 a.m. to 9 a.m. However, the meeting may end earlier if all persons desiring to speak have been heard.

If you require special accommodations, such as a sign language interpreter, please send us an e-mail to regulations@aphis.usda.gov.

If you are interested in making a presentation at the meeting, please register in advance by calling the Regulatory Analysis and Development voice mail at (301) 734-4339 or by sending an e-mail to regulations@aphis.usda.gov. The message should include your name, telephone number, organization, if any, and the topic of your presentation. On the day of the meeting, you may also register from 8:30 to 9 a.m. at the meeting site.

To allow everyone wishing to speak an opportunity to be heard, participants should limit their presentations to 10 minutes. Depending upon the number of speakers, we may further limit the time for presentations so that everyone wishing to speak has the opportunity. Starting with the advance registrants, we will call speakers in the order in which they registered.

If you plan to present a written statement, we ask that you provide a copy of your statement to the chairperson of the meeting.

The meeting will be recorded. The complete record, including the transcript and any written statements, will be available to the public.

The business meeting on February 1 begins at 10 AM, in the Clearwater National Forest Headquarters Office Building, 12730 Highway 12, Orofino, Idaho. Agenda topics will include discussion of potential projects. A public forum will begin at 2:30 PM (PST).

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 possible impact of 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 services 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. 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 services to the Government.

2. The action will 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 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 services are proposed for addition to Procurement List for production by the nonprofit agencies listed:

On November 2 and November 30, 2001, the Committee for Purchase From People Who Are Blind or Severely Disabled published notices (66 FR 55635 and 59778) of proposed additions to and deletions from the Procurement List:

After consideration of the material presented to it concerning capability of qualified nonprofit agencies to provide the commodity and services and impact of the additions on the current or most recent contractors, the Committee has determined that the commodity and services listed below are 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 commodity and services to the Government.

2. The action will not have a severe economic impact on current contractors for the commodity and services.

3. The action will result in authorizing small entities to furnish the commodity and services to the Government.

4. 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 commodity and services proposed for addition to the Procurement List. Accordingly, the following commodity and services are added to the Procurement List:

This action does not affect current contracts awarded prior to the effective date of this addition or options that may be exercised under those contracts.

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.

2. The action will not have a severe economic impact on future contractors for the commodity and the service.

3. The action will result in authorizing small entities to furnish the commodity and the service to the Government.

4. 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 commodity and the service deleted from the Procurement List.

After consideration of the relevant matter presented, the Committee has determined that the commodity and the service 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. Accordingly, the following commodity and service are deleted from the Procurement List:

Unless otherwise indicated, all citations to the Tariff Act of 1930, as amended (the “Act”), are references to the provisions effective January 1, 1995, the effective date of the amendments made to the Act by the Uruguay Round Agreements Act. In addition, unless otherwise indicated, all citations to the Department of Commerce's (“Department”) regulations are to 19 CFR part 351 (2001).

On January 7, 1997, the Department suspended the antidumping duty investigation on sodium azide from Japan (62 FR 973). Pursuant to section 751(c), the Department initiated a sunset review of the suspended investigation by publishing notice of the initiation in the Federal Register , December 3, 2001 (66 FR 60184). In addition, as a courtesy to interested parties, the Department sent letters, via certified and registered mail, to each party listed on the Department's most current service list for this proceeding to inform them of the automatic initiation of the sunset review of this suspended investigation.

No domestic interested party in the sunset review of this suspended investigation responded to the notice of initiation by the December 18, 2001, deadline ( see section 351.218(d)(1)(i) of Procedures for Conducting Five-year (“Sunset”) Reviews of Antidumping and Countervailing Duty Orders, 63 FR 13520 (March 20, 1998) (“ Sunset Regulations ”)).

Pursuant to section 751(c)(3)(A) of the Act and § 351.218(d)(1)(iii)(B)(3) of the Sunset Regulations, if no domestic interested party responds to the notice of initiation, the Department will issue a final determination, within 90 days after the initiation of the review, terminating the suspended investigation. Because no domestic interested party responded to the notice of initiation by the applicable deadline, December 18, 2001, we are terminating the suspended antidumping investigation of sodium azide from Japan.

The termination of the suspended investigation is effective as to all entries, or withdrawals from warehouse, of the subject merchandise on or after January 7, 2002.

NOAA has established a program to reduce excess fishing capacity by paying fishermen to (1) surrender their fishing permits or (2) both, surrender their permits and either scrap their vessels or restrict vessel titles to prevent fishing. Buybacks can be funded by a Federal loan to the industry or by direct Federal or other funding. Depending upon the type of buyback involved, the program can entail the submission of buyback requests by industry, the submission of bids, referenda if fishery participants, and reporting of the collection of fees to repay a Federal loan. For buybacks involving State-managed fisheries, the State may need to develop the buyback plan and comply with other information requirements.

In its request for renewed Paperwork Reduction Act approval NOAA will also request the merger of referenda requirements currently approved under 0648-0413 and the addition of a provision that would allow the public 30 days to advise of any holder or owner claims that conflict with accepted bidders’ representations about reduction permit ownership or reduction vessel ownership.

Paper forms or submission are primarily used.

OMB Number : 0648-0376.

Form Number : None.

Type of Review : Regular submission.

Affected Public : Business or other for-profit organizations; individuals or households; and State, Local, or Tribal government.

Estimated Number of Respondents : 1,272.

Estimated Time Per Response : 6,634 hours for a business plan, 4 hours for a referenda vote, 4 hours for an invitation to bid, 10 minutes to submit a fish ticket, 2 hours for a monthly buyer report, 4 hours for an annual buyer report, 2 hours for a seller/buyer report, 270 hours for a state approval of plans and amendments to state fishery management plan, and 1 hour for advising of any holder or owner claims that conflict with accepted bidders’ representations about reduction permit ownership or reduction vessel ownership.

Estimated Total Annual Burden Hours : 37,119.

Estimated Total Annual Cost to Public : $6,000.

Comments are invited on: (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.

Under current regulations NMFS may select for observer coverage any fishing trip by a vessel that has a permit for Atlantic Highly Migratory Species (HMS). NMFS will advise vessel owners in writing when their vessels have been selected. The owners of those vessels are then required to notify NMFS before commencing any fishing trip for Atlantic HMS. Such notification allows NMFS to arrange for observer placements and assignments. The estimated number of responses exceeds the number of respondents due to multiple trips taken within a particular season.

Notification can be made by phone, fax, or letter.

OMB Number : 0648-0374.

Form Number : None.

Type of Review : Regular submission.

Affected Public : Business or other for-profit organizations; individuals or households.

Estimated Number of Respondents : 212.

Estimated Time Per Response : 2 minutes.

Estimated Total Annual Burden Hours : 295.

Estimated Total Annual Cost to Public : $4,468.

Comments are invited on: (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.

As required in the reasonable and prudent measures in the Endangered Species Act, Section 7 biological opinion on the effects of the Bering Sea and Aleutian Islands and Gulf of Alaska pollock, Atka mackerel, and Pacific cod fisheries on the endangered Steller sea lions, National Marine Fisheries Service (NMFS) has implemented changes to information collected from fishery participants. Any vessel that is registered for directed fishing for Pacific cod, pollock, and Atka mackerel in the exclusive economic zone off Alaska must install a vessel monitoring system (VMS) unit and operate the VMS while directed fishing for each of the species. The VMS unit automatically transmits location information every 20 minutes. NOAA uses the information for determining vessel locations and enforcing the closure of areas of critical habitat. Participants must also fax NOAA a check-in report when a VMS unit has been installed.

The position reports are electronic and automatic. Check-in reports must be faxed.

OMB Number : 0648-0445.

Form Number : None.

Type of Review : Regular submission.

Estimated Number of Respondents : 539.

Affected Public : Business or other for-profit organizations.

Estimated Time Per Response : 6 hours to install a VMS, 4 hours per year to maintain a VMS, 5 seconds for an automated position report, and 12 minutes to fax a check-in report.

Estimated Total Annual Burden Hours : 13,044.

Estimated Total Annual Cost to Public : $811,000.

Comments are invited on: (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.

Monday, January 28, 2002, from 1 p.m. to 4 p.m. —the Ecosystem Planning Committee will meet.

Tuesday, January 29, 2002, from 8 a.m. until noon the Ecosystem Planning Committee will continue its meeting.

Tuesday, January 29, 2002, from 1 p.m. to 4 p.m.—the Squid, Mackerel, Butterfish Committee will meet.

Tuesday, January 29, 2002, from 4 p.m. to 5 p.m. —the Protected Resources Committee will meet.

Wednesday, January 30, 2002, from 9 a.m. to 10. a.m.—the Executive Committee will meet.

Wednesday, January 30, 2002 —the Council will convene at 10 a.m. and adjourn at 5 p.m.

Thursday, January 31, 2002, 8 a.m. until 4 p.m. —Council will meet.

Agenda items for the committees and Council meeting(s), as appropriate, are: Discussion of alternative recreational and commercial management approaches for MAFMC species; review scoping comments for Amendment 9 to the Squid, Mackerel, Butterfish FMP, review Amendment 9 issues paper, finalize management measures for Amendment 9 public hearing draft, and develop timeline for Amendment 9 completion; review update to recent bottlenose dolphin take reduction team's report; receive and discuss the advisory report on the status of monkfish, Georges Bank winter flounder, and Loligo squid developed at the 34th Stock Assessment Workshop; discuss approval of Framework Adjustment1 to the Monkfish FMP (options include: 1) no action and allowing the FMP Year 4 default measures to take effect eliminating the directed fishery, 2) the preferred alternative of postponing the Year 4 default measures for one year and adjusting trip limits and days at sea allocations to achieve fishing year 2000 landing levels after accounting for the court-ordered adjustment to the gillnet trip limits, 3) adjusting management measures to reduce catches to the Years 2 and 3 total allowable catch targets); convene public scoping meeting for Amendment 2 to the Monkfish FMP; receive and discuss organizational and committee reports including the New England Council's report regarding possible actions on herring, groundfish, monkfish, red crab, scallops, skates, and whiting.

On Wednesday, January 30, there will be a scoping meeting for Amendment 2 to the Monkfish Fishery Management Plan (FMP). The New England and Mid-Atlantic Fishery Management Councils propose to amend the Monkfish FMP. The amendment process will serve two purposes: it will enable the Councils to modify the FMP rules as needed and to update the analysis of the cumulative impact of the FMP on the human environment. In the process, the Councils will prepare a Supplemental Environmental Impact Statement (SEIS) as described in the National Environmental Policy Act for the amendment. This notice is to inform you that the Councils will gather information for the preparation of the SEIS and to ask for your input on the range of issues to be addressed and alternatives to be considered. The Councils are taking this action for the following reasons: (1) to address updated scientific information on the status of the stocks, (2) to address problems with the implementation and enforcement of the current management program, (3) to evaluate the impact of the rebuilding program on the human environment, (4) to consider proposals for providing controlled access to the monkfish resource south of the North Carolina/Virginia border to vessels from that area that are currently excluded, and (5) to comply with a federal Court Order to update the Essential Fish Habitat (EFH) elements of the FMP. You may comment at any of the public Council or committee meetings where Amendment 2 is on the agenda, or you may submit written comments by February 11, 2002 to:

Paul J. Howard, Executive Director, New England Fishery Management Council, 50 Water Street, Newburyport, MA 01950; telephone: 978-465-0492, fax: 978-465-3116.

Although non-emergency issues not contained in this agenda may come before the Council for discussion, these issues may not be the subject of formal Council action during this meeting. Council action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final actions to address such emergencies.

This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Joanna Davis at the Mid-Atlantic Council (see ADDRESSES ) least 5 days prior to the meeting date.

The primary purpose of the GMT working meeting is to plan the GMT's annual schedule and strategies to effectively aid the Council in managing 2002 West Coast groundfish fisheries and Council initiatives expected to arise in 2002. Additionally, the GMT will discuss groundfish management measures in place for the winter and spring months, respond to assignments relating to implementation of the Council’s groundfish strategic plan, consider technical aspects of draft stock rebuilding plans and analyses, review new groundfish stock assessments and survey results, and address other assignments relating to groundfish management.

Although nonemergency issues not contained in this agenda may come before the GMT for discussion, those issues may not be the subject of formal GMT action during this meeting. GMT action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice requiring emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the GMT's intent to take final action to address the emergency.

The meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Ms. Carolyn Porter at 503-326-6352 at least 5 days prior to the meeting date.

EFPs and SRPs are requested and issued under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. 1801 et seq .) and/or the Atlantic Tunas Convention Act (16 U.S.C. 971 et seq .). Regulations at 50 CFR 600.745 and 50 CFR 635.32 govern scientific research activity, exempted fishing, and exempted educational activity with respect to Atlantic HMS.

Issuance of EFPs and/or SRPs may be necessary because possession of certain shark species is prohibited, possession of billfishes on board commercial fishing vessels is prohibited, and because the commercial fisheries for bluefin tuna, swordfish and large coastal sharks may be closed for extended periods, during which collection of live animals and/or biological samples would otherwise be prohibited. In addition, NMFS regulations at 50 CFR 635.32 regarding implantation or attachment of archival tags in Atlantic HMS require prior authorization and a report on implantation activities.

NMFS also seeks public comment on its intention to issue EFPs for the purpose of collecting biological samples under at-sea fisheries observer programs. NMFS intends to issue EFPs to any NMFS or NMFS-approved observer to bring onboard and possess, for scientific research purposes, biological sampling, measurement, etc., any Atlantic swordfish, Atlantic shark, or Atlantic billfish, provided the fish is a recaptured tagged fish, a dead fish prior to being brought onboard, or specifically authorized for sampling by the Director of the Office of Sustainable Fisheries at the request of the Southeast Fisheries Science Center or Northeast Fisheries Science Center. On average, several humdred swordfish and sharks are collected by at-sea observers under such EFPs any given year.

Collection of bluefin tuna would be authorized for scientific research age and growth, genetic, and spawning studies. In 2001, five permits for bluefin tuna archival tagging and research were issued. In 2002, pursuant to the International Commission for the Conservation of Atlantic Tunas (ICCAT) recommendations calling for research that addresses bluefin tuna spawning locations, NMFS intends to issue SRPs and/or EFPs for U.S. participation in an international program that could involve the landing of up to 15 metric tons of bluefin tuna and other regulated HMS for scientific sampling. This would be in addition to SRPs and EFPs issued for other tuna research.

In 2001 NMFS issued one EFP allowing commercial fishing vessels to assist NOAA scientists, and one SRP involving NOAA research vessels, in order that experiments in the Northeast Distant Waters of Grand Banks and in the DeSoto Canyon area of the Gulf of Mexico, respectively, could be conducted. These experiments addressed gear modifications to reduce bycatch in the Atlantic HMS pelagic longline fisheries.

NMFS also intends to continue to issue EFPs to vessel operators requesting offloading windows in the Atlantic Swordfish fishery, in the event the swordfish fishery is closed and a vessel is not equipped with a vessel monitoring system that would enable it to remain at sea after the announced closure date. NMFS anticipates that commercial EFP applicants would be captains of larger vessels out on extended trips at the time of a closure announcement. These applicants would benefit from delayed offloading by avoiding market gluts and cold storage problems.

NMFS also seeks public comment on its intention to issue EFPs for distant water pelagic longline vessels for the purpose of expanding access of U.S. vessels into other markets while continuing to collect information about U.S. fishing effort and landings. NMFS would consider applications from any U.S. Atlantic pelagic longline vessel. NMFS intends to issue such EFPs to any U.S. vessel fishing under contract to another nation, provided its landings and discards are consistent with ICCAT recommendations and, due to the requirements of the contract, those landings are being reported to ICCAT by that other nation or otherwise appropriately accounted for.

NMFS is also seeking public comment on its intention to issue EFPs for the collection of restricted species of sharks for the purpose of public display. In the Final Fishery Management Plan for Atlantic Tunas, Swordfish and Sharks (HMS FMP), NMFS established a public display quota of 60 metric tons wet weight for this purpose. NMFS has preliminarily determined that up to 3,000 sharks could be taken with this current quota and such harvest would be consistent with the most recent environmental impact statement prepared for this fishery. NMFS believes that harvesting this amount for public display will have a minimal impact on the stock. In 2001, nine EFPs were issued for the collection of sharks for display purposes.

Generally, the authorized collections or exemptions would involve activities otherwise prohibited by regulations implementing the HMS FMP and Amendment 1 to the Atlantic Billfish Fishery Management Plan. The EFPs, if issued, may authorize recipients to fish for and possess tunas, billfishes, swordfish and sharks outside the applicable Federal commercial seasons, size limits and retention limits, or to fish for and possess prohibited species.

NMFS intends to undertake rulemaking to revise certain aspects of the procedures for issuing EFPs and complying with EFP requirements for Atlantic HMS. Permits may be issued under the current regulations and be valid until new regulations become effective, at which time revised permits may be issued. A final decision on issuance of any EFPs/SRPs will depend on the submission of all required information about the proposed activities, NMFS' review of public comments received on this notice, conclusions in the Final Environmental Impact Statement (EIS) and any subsequent Environmental Assessments (EAs) or EISs contained in the Final HMS FMP (64 FR 13575; March 19, 1999) and any consultations with any appropriate Regional Fishery Management Councils, states, or Federal agencies. NMFS does not anticipate any environmental impacts from the issuance of these EFPs other than impacts already assessed in the Final HMS FMP and subsequent EAs.

The entire meeting is devoted to the discussion of classified information as defined in section 552b(c)(1), Title 5 of the U.S. Code and therefore will be closed. The Board will discuss several current critical intelligence issues and advise the Director, DIA, as to the successful accomplishment of the mission assigned to the Joint Military Intelligence College.

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

The proposed system reports, as required by 5 U.S.C. 552a(r) of the Privacy Act of 1974, as amended, was submitted on December 28, 2001, to the House Committee on Government Reform, the Senate Committee on Governmental Affairs, and the Office of Management and Budget (OMB) pursuant to paragraph 4c of Appendix I to OMB Circular No. A-130, “Federal Agency Responsibilities for Maintaining Records About Individuals,” dated February 8, 1996 (February 20, 1996, 61 FR 6427).

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

The specific changes to the records systems being amended are set forth below followed by the notices, as amended, published in their entirety. The proposed amendments are not within the purview of subsection (r) of the Privacy Act of 1974 (5 U.S.C. 552a), as amended, which requires the submission of a new or altered system report.

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

The proposed system report, as required by 5 U.S.C. 552a(r) of the Privacy Act of 1974, as amended, was submitted on December 28, 2001, to the House Committee on Government Reform, the Senate Committee on Governmental Affairs, and the Office of Management and Budget (OMB) pursuant to paragraph 4c of Appendix I to OMB Circular No. A-130, ‘Federal Agency Responsibilities for Maintaining Records About Individuals,’ dated February 8, 1996 (February 20, 1996, 61 FR 6427).

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

The proposed action is not within the purview of subsection (r) of the Privacy Act (5 U.S.C. 552a), as amended, which would require the submission of a new or altered system report for each system.

Provide shoreline protection against wave attack from coastal storms to the San Clemente shoreline. Running along the entire length of the San Clemente shoreline is a portion of the Los Angeles to San Diego (Lossan) railroad corridor. The Lossan is a major passenger rail line linking San Diego to the rest of the United States. The Lossan is owned by the Orange County Transportation Authority (OCTA). This commuter rail corridor is among the busiest in the country and separates the beach from the bluff. Loss of shoreline protection and recreational beach width is a continuous problem for the city of San Clemente. Damages to coastal residential and commercial properties from storm-induced waves have become a serious threat over the past several years. The study will investigate alternatives to provide shoreline protection.

Alternatives that may be considered include non-structural and/or structural measures to provide protection against wave attack from coastal storms. Non-structural measures include beach and near-shore nourishment with dredged sand.

The Corps and the city of San Clemente are preparing a joint Environmental Impact Statement/Environmental Impact Report (EIS/EIR) to address potential impacts associated with the proposed project. The Corps is the Lead Federal Agency for compliance with NEPA for the project, and the city of San Clemente is the Lead State Agency for compliance with the CEQA for the non-Federal aspects of the project. The Draft EIS/EIR (DEIS/EIR) document will incorporate public concerns in the analysis of impacts associated with the Proposed Action and associated project alternatives. The DEIS/EIR will be sent out for a 45-day public review period, during which time both written and verbal comments will be solicited on the adequacy of the document. The Final EIS/EIR (FEIS/EIR) will address the comments received on the DEIS/EIR during public review, and will be furnished to all who commented on the DEIS/EIR, and is made available to anyone that requests a copy during the 30-day public comment period. The final step involves, for the Federal EIS, preparing a Record of Decision (ROD) and, for the state EIR, certifying the EIR and adopting a Mitigation Monitoring and Reporting Plan. The ROD is a concise summary of the decisions made by the Corps from among the alternatives presented in the FEIS/EIR. The ROD can be published immediately after the FEIS public comment period ends. A certified EIR indicates that the environmental document adequately assesses the environmental impacts of the proposed project with respect to CEQA. A formal scoping meeting to solicit public comment and concerns on the proposed action and alternatives will be held on January 10, 2002 at 7 p.m., in the Multipurpose Room (1 & 2) in the San Clemente Senior Center, 242 Avenue Del Mar, San Clemente, California.

This feasibility study was authorized by U.S. House of Representatives Committee Resolution on Transportation and Infrastructure (Docket 2593), dated April 15, 1999, which states, in part: “that the Secretary of the Army is requested to review the report of the Chief of Engineers on the Ventura River, Ventura County, California, published as House Document 323, 77th Congress, 1st Session, and other pertinent reports, with a view to determining whether any modifications of the recommendations contained therein are advisable at this time, in the interest of environmental restoration and protection, and related purposes, with particular attention to restoring anadromous fish populations on Matilija Creek and returning natural sand replenishment to Ventura and other Southern California beaches.”

Matilija Dam is located on Matilija Creek, a tributary of the Ventura River, approximately 16 miles upstream from the Pacific Ocean. The dam is located in Ventura County California, approximately 7 miles and 25 miles from the Cities of Ojai and Ventura, California, respectively. The feasibility study area currently includes the Matilija Dam and the area immediately upstream, and downstream of the dam to the Ventura River Estuary. The non-federal sponsor of the feasibility study is the Ventura County Flood Control District.

Matilija Dam was constructed in the late 1940's by Ventura County Flood Control to provide water storage for agricultural needs. Matilija Dam is a concrete arch structure 190 feet in height with an arc length of 620 feet at its crest. Sediment carried by Matilija Creek has deposited behind the dam and filled the reservoir, rendering the structure useless as a water storage facility. It is estimated that 6,000,000 cubic yards of sediment lies trapped behind the dam.

The dam no longer provides any flood control protection due to sedimentation behind the dam. There is some continued water supply use. The Casitas Municipal Water District currently operates the dam under a lease agreement from the County of Ventura, which expires in 2009. The operation is an integral part of the Robles/Casitas Reservoir water supply facilities and is estimated to currently contribute approximately 400 acre-feet of water per year. This water function, however, is projected to diminish rapidly as the reservoir continues to fill with sediments, and is expected to effectively cease by 2010 after the reservoir fills completely with sediment.

Presently, the dam is considered to be a major contributor to the declining numbers of steelhead trout in Matilija Creek. If no action is taken to secure passage for the steelhead trout to reach the upper watershed and its tributaries, the dam will continue to obstruct this endangered species, thereby limiting the amount of spawning and rearing habitat. In addition, the dam would continue to act as a barrier for wildlife movement for other terrestrial and aquatic species.

The feasibility study will focus on addressing the problems and needs caused by Matilija Dam with the primary objective of the feasibility study being to restore the Matilija Creek riverine ecosystem. Other objectives that are considered appropriate may involve possible beneficial use of the sediment behind the dam for beach nourishment or other environmental restoration.

In general, alternative plans will investigate reasonable alternatives to restore Matilija Creek, primarily by removing Matilija Dam. Feasible alternatives for the removal of sediment behind the dam and the beneficial use of that sediment will also be investigated. Significant beneficial impacts to the riverine ecosystem (especially to steelhead trout) are expected from restoration alternatives identified in the feasibility study.

Participation of all interested Federal, State, and County agencies, groups with environmental interests, and any interested individuals are encouraged. Public involvement will be most beneficial and worthwhile in identifying the scope of pertinent, significant environmental issues to be addressed, identifying and eliminating from detailed study issues that are not significant, offering useful information such as published or unpublished data, providing direct personal experience or knowledge which informs decision making, and recommending suitable mitigation measures to offset potential impacts from the proposed action or alternatives.

A public scoping meeting is scheduled at the Ventura County Hall of Administration, County Board of Supervisors Meeting Room, 800 South Victoria Avenue, Ventura, CA 93009 at 7 pm on January 31, 2002. The purpose of the scoping meeting will be to gather information from the general public or interested organizations about issues and concerns that they would like to see addressed in the DEIS. Comments may be delivered in writing or verbally at the meeting or sent in writing to the Los Angeles District at the address given above. The scoping period will conclude March 12, 2002.

The DEIS is expected to be available to the public for review and comment beginning in the winter of 2004.

For the Sand Bypassing component of the study, the purpose of the report shall focus on the alternatives for the sand bypassing system needed for accommodating the annual required dredge volume.

For the Regional Beneficial Use component, the purpose is to provide beneficial uses of the material for the Ventura County region for a proposed sand bypassing system at Ventura Harbor, California. The report shall be based on the Ventura Harbor Sand Bypass Regional Beneficial Uses Reconnaissance Report (Los Angeles District, 1997), to modify the existing federal navigation project for the purpose of providing regional uses of the dredged material for storm damage protection, environmental restoration and enhancement, and other beneficial uses.

Ventura Harbor is a small craft commercial and recreational harbor located approximately one hundred (100) kilometers northwest of the City of Los Angeles. The Los Angeles District currently maintains navigable channels by dredging an entrance channel and several sand traps outside of the harbor. The two (2) primary sand traps have a total capacity of approximately 640,000 m 3 and are located at the seaward end of the entrance channel and adjacent to the upcoast side of the North Jetty. Presently the Los Angeles District maintenance project is designed to dredge every two (2) years at an estimated dredge quantity of 615,000 m 3 per episode. Due to annual budgetary constraints, the Los Angeles District, in practice, maintains the entrance channel and sand traps on a yearly basis, removing on the average approximately 535,000 m 3 of sand per dredging episode. Fiscal year 2000 dredging resulted in the removal of approximately 140,000 m 3 from the navigation channel and channel trap, and approximately 320,000 m 3 from sand trap adjacent to the North Jetty. The dredged sands have historically been placed directly onto McGrath State Beach, in the nearshore environment adjacent to McGrath State Beach, directly onto South Beach, or, on a few occasions, onto the upcoast groin field cell.

Alternatives that may be considered include selection of various disposal sites as well as various sites and dredging methodologies for the dredging side of the bypass system, continued use of periodic dredging with beach/nearshore disposal, and no-project.

The Corps and the Ventura Port District are preparing a joint Environmental Impact Statement/Environmental Impact Report (EIS/EIR) to address potential impacts associated with the proposed project. The Corps is the Lead Federal Agency for compliance with NEPA for the project, and the Ventura Port District is the Lead State Agency for compliance with the CEQA for the non-Federal aspects of the project. The Draft EIS/EIR (DEIS/EIR) document will incorporate public concerns in the analysis of impacts associated with the Proposed Action and associated project alternatives. The DEIS/EIR will be sent out for a 45-day public review period, during which time both written and verbal comments will be solicited on the adequacy of the document. The Final EIS/EIR (FEIS/EIR) will address the comments received on the DEIS/EIR during public review, and will be furnished to all who commented on the DEIS/EIR, and is made available to anyone that requests a copy during the 30-day public comment period. The final step involves, for the federal EIS, preparing a Record of Decision (ROD) and, for the state EIR, certifying the EIR and adopting a Mitigation Monitoring and Reporting Plan. The ROD is a concise summary of the decisions made by the Corps from among the alternatives presented in the FEIS/EIR. The ROD can be published immediately after the FEIS public comment period ends. A certified EIR indicates that the environmental document adequately assesses the environmental impacts of the proposed project with respect to CEQA. A formal scoping meeting to solicit public comment and concerns on the proposed action and alternatives will be held on January 8, 2002, at 6:00 P.M., in the Channel Islands National Park Visitor Center, 1901 Spinnaker Drive, Ventura, California.

None.

Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that the Office of Management and Budget (OMB) provide interested Federal agencies and the public an early opportunity to comment on information collection requests. OMB may amend or waive the requirement for public consultation to the extent that public participation in the approval process would defeat the purpose of the information collection, violate State or Federal law, or substantially interfere with any agency's ability to perform its statutory obligations. The Leader, Regulatory Information Management Group, Office of the Chief Information Officer, publishes that notice containing proposed information collection requests prior to submission of these requests to OMB. Each proposed information collection, grouped by office, contains the following: (1) Type of review requested, e.g. new, revision, extension, existing or reinstatement; (2) Title; (3) Summary of the collection; (4) Description of the need for, and proposed use of, the information; (5) Respondents and frequency of collection; and (6) Reporting and/or Recordkeeping burden. OMB invites public comment.

Type of Review: Revision.

Title: Child Care Provider Loan Forgiveness Application and Forgiveness Forbearance Form.

Frequency: Annually.

Affected Public: Individuals or household; Businesses or other for-profit; Not-for-profit institutions; Federal Government; state, local, or tribal gov't, SEAs or LEAs.

Reporting and Recordkeeping Hour Burden: Responses: 2,790. Burden Hours: 618.

Abstract: The Child Care Provider Loan Forgiveness Application is used to determine whether borrowers meet the eligibility requirements for Child Care Provider Loan Forgiveness Program which is a demonstration program administered on a first-come, first-serve basis (subject to the availability of funds) and is intended to bring more highly trained individuals into the early child care field for longer periods. Under this program, individuals who work full-time in certain child care facilities that serve low-income families and meet other qualifications may be eligible to have up to 100% of their Direct Loan and/or Federal Family Education Loan (FFEL) program loan forgiven. The Child Care Provider Loan Forgiveness Forbearance Form is required to fulfill program guidance that provides forbearance for child care providers and to determine the child care providers eligibility for forbearance.

Requests for copies of the proposed information collection request may be accessed from http://edicsweb.ed.gov, or should be addressed to Vivian Reese, Department of Education, 400 Maryland Avenue, SW., Room 4050, Regional Office Building 3, Washington, DC 20202-4651. Requests may also be electronically mailed to the Internet address OCIO_RIMG@ed.gov or faxed to 202-708-9346. Please specify the complete title of the information collection when making your request.

Comments regarding burden and/or the collection activity requirements should be directed to Joseph Schubart at his Internet address Joe.Schubart@ed.gov. Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339.

Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that the Office of Management and Budget (OMB) provide interested Federal agencies and the public an early opportunity to comment on information collection requests. OMB may amend or waive the requirement for public consultation to the extent that public participation in the approval process would defeat the purpose of the information collection, violate State or Federal law, or substantially interfere with any agency's ability to perform its statutory obligations. The Leader, Regulatory Information Management Group, Office of the Chief Information Officer, publishes that notice containing proposed information collection requests prior to submission of these requests to OMB. Each proposed information collection, grouped by office, contains the following: (1) Type of review requested, e.g. new, revision, extension, existing or reinstatement; (2) Title; (3) Summary of the collection; (4) Description of the need for, and proposed use of, the information; (5) Respondents and frequency of collection; and (6) Reporting and/or Recordkeeping burden. OMB invites public comment.

Type of Review: New.

Title: Descriptive Study of the Emergency Immigrant Education Program.

Frequency: Semi-Annually.

Affected Public: State, Local, or Tribal Gov't, SEAs or LEAs; Businesses or other for-profit.

Reporting and Recordkeeping Hour Burden: Responses: 555. Burden Hours: 317.

Abstract: The goals of the Descriptive Study of Immigrant Education are to provide information about: (1) The types of programs and services for immigrant children and youth and best practices for serving this population; (2) the degree to which immigrant students are meeting state standards; and (3) the way in which services are paid for and provided. This study will include case studies of 15 districts that represent diverse circumstances and populations, and a range of approaches to serving recent immigrant children and youth.

Requests for copies of the proposed information collection request may be accessed from http://edicsweb.ed.gov, or should be addressed to Vivian Reese, Department of Education, 400 Maryland Avenue, SW., Room 4050, Regional Office Building 3, Washington, DC 20202-4651. Requests may also be electronically mailed to the Internet address OCIO_RIMG@ed.gov or faxed to 202-708-9346. Please specify the complete title of the information collection when making your request. Comments regarding burden and/or the collection activity requirements should be directed to Sheila Carey at (202) 708-6287 or via her Internet address Sheila.Carey@ed.gov. Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339.

Under the Special Focus Competition, we will award grants or enter into cooperative agreements that focus on problem areas or improvement approaches in postsecondary education. We have included an invitational priority to encourage proposals designed to support the formation of educational consortia of institutions and organizations in the United States and the European Union to encourage cooperation in the coordination of curricula, the exchange of students and the opening of educational opportunities between the United States and the European Union. The invitational priority is issued in cooperation with the European Union. European institutions participating in any consortium proposal responding to the invitational priority may apply to the European Commission's Directorate General for Education and Culture for additional funding under a separate European competition.

The Secretary is particularly interested in applications that meet the following invitational priority. However, an application that meets this invitational priority does not receive competitive or absolute preference over other applications (34 CFR 75.105(c)(1)).

Invitational Priority: Projects that support consortia of institutions of higher education that promote institutional cooperation and student mobility between the United States and the Member States of the European Union.

The Secretary gives equal weight to the listed criteria. Within each of the criteria, the Secretary gives equal weight to each of the factors.

In evaluating applications for grants under this program competition, the Secretary uses selection criteria chosen from those listed in 34 CFR 75.210.

For Applications Contact: Education Publications Center (ED Pubs), P.O. Box 1398, Jessup, MD 20794-1398, Telephone (toll free) 1-877-433-7827, fax (301) 470-1244. If you use a telecommunications device for the deaf (TDD), you may call (toll free) 1-877-576-7734. You may also contact ED Pubs at its web site: http://www.ed.gov/pubs/edpubs.html or you may contact ED Pubs at its e-mail address: edpubs@inet.ed.gov.

If you request an application from ED Pubs, be sure to identify this competition as follows: CFDA number 84.116J. You may also request application forms by calling 732-544-2504 (fax on demand), or application guidelines by calling 202-358-3041 (voice mail) or submitting the name of the competition and your name and postal address to FIPSE@ed.gov (e-mail).

Applications are also listed on the FIPSE Web Site: http://www.ed.gov/FIPSE e-APPLICATIONS are available at: http://e-grants.ed.gov.

Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339. For additional program information call the FIPSE office (202-502-7500) between the hours of 8 a.m. and 5 p.m., Eastern Time, Monday through Friday.

Individuals with disabilities may obtain this document in an alternative format (e.g., Braille, large print, audiotape, or computer diskette) on request to the contact number listed under For Applications Contact.

Individuals with disabilities also may obtain a copy of the application package in an alternative format by contacting that number. However, the Department is not able to reproduce in an alternative format the standard forms included in the application package.

In Fiscal Year 2002 the U.S. Department of Education is continuing to expand its pilot project of electronic submission of applications to include additional grant programs and additional discretionary grant competitions. The European Community-United States of America Cooperation Program in Higher Education and Vocational Education and Training CFDA 84.116J is included in the pilot project. If you are an applicant under the European Community-United States of America Cooperation Program in Higher Education and Vocational Education and Training, you may submit your application to us in either electronic or paper format.

The pilot project involves the use of the Electronic Grant Application System (e-APPLICATION, formerly e-GAPS) portion of the Grant Administration and Payment System (GAPS). We request your participation in this pilot project. We shall continue to evaluate its success and solicit suggestions for improvement.

If you participate in this e-APPLICATION pilot, please note the following:

• Your participation is voluntary.

• You will not receive any additional point value or penalty because you submit a grant application in electronic or paper format.

• You can submit all documents electronically, including the Title Page, (substitutes for the ED Form 424), Budget Information-Non-Construction Programs (substitutes for the ED Form 524), and all necessary assurances and certifications.

• Within three working days of submitting your electronic application fax a signed copy of the Title Page to the Application Control Center after following these steps:

1. Print the Title Page from the e-APPLICATION system.

2. Make sure that the institution's Authorizing Representative signs this form.

3. Before faxing this form, submit your electronic application via the e-APPLICATION system. You will receive an automatic acknowledgement, which will include a PR/Award number (an identifying number unique to your application).

4. Place the PR/Award number in the upper right hand corner of the Title Page.

5. Fax the Title Page to the Application Control Center at (202) 260-1349.

• We may request that you give us original signatures on all other forms at a later date.

You may access the electronic grant application for the European Community-United States of America Cooperation Program in Higher Education and Vocational Education and Training at: http://e-grants.ed.gov.

Due to software upgrades, it is anticipated that the e-Application software will be unavailable for several days in mid-January. The tentative dates for this system down time are January 11-21, 2002. Please check this site for future updates on system availability.

We have included additional information about the e-APPLICATION pilot project (see Parity Guidelines between Paper and Electronic Applications) in the application package.

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

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

This notice announces our finding that the emissions budgets contained in the PM10 State Implementation Plan for Clark County , submitted by the State of Nevada on July 23, 2001, are adequate for transportation conformity purposes. EPA Region IX made this finding in a letter to the Nevada Division of Environmental Protection on November 9, 2001. We are also announcing this finding on our conformity web site: http://www.epa.gov/oms/traq , (once there, click on the “Conformity” button, then look for “Adequacy Review of SIP Submissions for Conformity”).

Transportation conformity is required by section 176(c) of the Clean Air Act. Our conformity rule requires that transportation plans, programs, and projects conform to state air quality implementation plans (SIPs) and establishes the criteria and procedures for determining whether or not they do. Conformity to a SIP means that transportation activities will not produce new air quality violations, worsen existing violations, or delay timely attainment of the national ambient air quality standards.

The criteria by which we determine whether a SIP's motor vehicle emission budgets are adequate for conformity purposes are outlined in 40 CFR 93.118(e)(4). One of these criteria is that the plan provide for attainment of the relevant ambient air quality standard by the applicable Clean Air Act attainment date. We have preliminarily determined that the Clark County PM10 plan does provide for attainment of the PM10 standards and, therefore, can be found adequate.

We have described our process for determining the adequacy of submitted SIP budgets in guidance (May 14, 1999 memo titled “Conformity Guidance on Implementation of March 2, 1999 Conformity Court Decision”). We followed this guidance in making our adequacy determination on the emissions budgets contained in the Clark County PM10 plan.

Materials or written comments to the Council can be sent to Peter Redmond, Designated Federal Officer/NACEPT, using the contact information below (e-mail is preferred). Also, contact Mr. Redmond for copies of the draft report on emerging trends and issues. The public is welcome to attend all portions of the meeting; members of the public expecting to submit written comments and/or make brief oral statements (suggested 5-minute limit) during the public comment session are encouraged to contact Mr. Redmond by January 22, 2002.

Meeting Access: Individuals requiring special accommodation at this meeting, including wheelchair access, should contact Mr. Redmond at least five business days prior to the meeting so that appropriate arrangements can be made.

The EMFAC model is part of the California Air Resources Board's (CARB's) Motor Vehicle Emission Inventory (MVEI) modeling system. The first three models in the system are the CALIMFAC, the WEIGHT and the EMFAC models. The CALIMFAC model estimates emission rates for California on-road vehicles when the vehicle is new and as it ages. The WEIGHT model determines each vehicle model year's accumulated mileage and the relative weight each vehicle model year should be given in the California statewide emission inventory. The EMFAC model combines the results from these two models, along with correction factors and other data, to produce emission factors for the entire California vehicle fleet.

Clean Air Act section 172(c)(3) and 40 CFR 51.112(a)(1) require that SIP inventories be based on the most current and applicable emission estimation models that are available at the time the SIP is developed. Clean Air Act section 176(c)(1) requires that the latest emission estimates be used in transportation conformity analyses. Transportation conformity is a Clean Air Act requirement to ensure that federally supported highway and transit activities are consistent with (“conform to”) the SIP. Conformity to a SIP means that a transportation activity will not cause or contribute to new violations of ambient air quality standards; worsen existing violations; or delay timely attainment of such standards.

Under 40 CFR 93.111(a), EPA must approve new versions of EMFAC for SIP development before they can be used in conformity analyses. In its November 30, 2001 letter, CARB requested that EPA approve EMFAC2000 for use in Bay Area ozone SIP development and transportation conformity determinations. EPA notes that EMFAC2000 would normally be considered the latest emissions model for statewide use in California SIP development (rather than an interim update to the EMFAC model as EMFAC7G was an interim update to EMFAC7F). EMFAC2000 is a significant change from previous EMFAC models and is capable of calculating motor vehicle emissions for all California areas. However, EMFAC2000 is now known to contain technical limitations. It would be inappropriate to approve EMFAC statewide for all SIPs and conformity determinations.

EPA is approving EMFAC2000 for ozone SIP development for only the Bay Area at this time. EPA is proceeding with this approval because: (1) EMFAC2000 is an improvement on existing available models despite certain technical limitations; and (2) CARB has committed to revise the Bay Area ozone attainment SIP's motor vehicle emissions budgets with EMFAC2001 or a successor model as part of its mid-course review SIP revision in April 2004. Additionally, we understand that the next EMFAC model will correct EMFAC2000's technical limitations and be available for use in all future California SIPs. Therefore, CARB does not currently intend to develop other SIPs with EMFAC2000.

In this notice, EPA is approving and announcing that EMFAC 2000, as developed by CARB and submitted for approval to EPA on November 30, 2001, is available to use in the development of ozone motor vehicle emission estimates in the Bay Area, as described above. Note that CARB refers to EMFAC in its request for approval as the SF Bay Area-EMFAC 2000.

CARB will fix the technical errors in EMFAC 2000 in its next version of EMFAC. At this time EPA understands that EMFAC2001 or its successor will be released by CARB before any additional California SIPs are submitted to EPA. EMFAC2001 or its successor will also include a user interface so local agencies can examine alternative scenarios and update local data (e.g., vehicle miles traveled (VMT), fleet characteristics). The future model will allow transportation agencies to complete their own conformity determinations. Note that the Bay Area SIP includes CARB's commitment to revise the SIP with the latest technical information as part of its mid-course review in April 2004, which was subject to the state public comment process. EPA understands that California will not be submitting EMFAC2001 or its successor for EPA approval until early 2003, so that CARB's submission of the mid-course review using the newly available model will occur within one year of EPA's approval of EMFAC2001 or its successor. This is consistent with EPA's past practice where older versions of models such as the national MOBILE model have been used prior to release of newer versions of the model that make certain corrections in emission estimation.

EPA is approving the model only for use to estimate ozone emissions. Since this approval is specific to ozone for the Bay Area, carbon monoxide microscale analyses in the Bay Area should continue to be based on EMFAC7F.

No. The transportation conformity rule (40 CFR part 93.111) requires that conformity analyses be based on the latest motor vehicle emissions model approved by EPA for SIP purposes for a state or area. When EPA approves a new emissions model like EMFAC2000, we normally establish a grace period before the model is required for new conformity analyses (40 CFR 93.111(b)). However, as explained above, EMFAC2000 is known to contain a few technical problems. Due to the limitations of EMFAC2000, it would be inappropriate to approve EMFAC2000 statewide for all SIP planning, and thus to require its use for conformity determinations in all areas, particularly those without a SIP and budgets based on EMFAC2000. Based on discussions with CARB, EPA understands that EMFAC2001 or its successor will correct the limitations and include additional improvements. Therefore, EPA is not approving EMFAC2000 for statewide SIP planning, and a conformity grace period for the entire state will not be established for EMFAC2000.

Although EPA's potential approval of EMFAC2001 or its successor will not occur until farther into the future, EPA currently intends to establish a grace period before EMFAC2001 or its successor would be required for new transportation conformity analyses across the state of California. From now until the end of such a grace period, nonattainment and maintenance areas outside the Bay Area can continue to use EMFAC7F and EMFAC7G as appropriate for new conformity analyses. For more information about the use of EMFAC7F and EMFAC7G, please see the April 16, 1998, EPA Region IX letter to CARB describing the applicability of these models for conformity analyses.

EMFAC2000 will apply for all future ozone conformity analyses in the Bay Area until one of the following two scenarios occurs (1) a revised attainment SIP and budgets with EMFAC2001 or its successor are submitted and EPA has found these revised budgets adequate or (2) the grace period for EMFAC2001 or its successor has expired. Since EPA is approving EMFAC2000 for use in the Bay Area based on CARB's commitment to revise the Bay Area ozone SIP once an improved model is available, EPA intends to approve the motor vehicle emission budgets in any Bay Area ozone SIP only until new budgets developed with the new model are submitted and found adequate for conformity purposes.

Since EMFAC2000 contains VMT estimates developed by CARB, CARB has committed in its November 30, 2001 letter requesting approval of EMFAC2000, to work with the Metropolitan Transportation Commission (MTC) to complete future conformity analyses in the Bay Area. Once EMFAC2001 or its successor is approved generally for use in California, MTC, like other MPOs, should be able to use the EMFAC model to examine alternative scenarios with its own VMT estimates for future conformity analyses.

EPA is approving EMFAC2000 as submitted by CARB on November 30, 2001 with the following limitations and conditions.

(1) The approval is limited to the Bay Area.

(2) The approval is limited to ozone.

(3) No statewide conformity grace period will be triggered.

(4) CARB will correct the technical limitations in EMFAC2001 or its successor, and EPA understands that the new model will be released by CARB for EPA approval before any additional California SIPs are submitted to EPA.

(5) CARB will revise the Bay Area ozone SIP with EMFAC2001 or its successor in its mid-course review of the Bay Area SIP by April 2004.

This action is directed to the public in general. This action may, however, be of interest to firms and individuals engaged in lead-based paint activities in Illinois. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

1. Electronically . You may obtain electronic copies of this Federal Register notice document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select “Laws and Regulations” and then look up the entry for this document under the “ Federal Register —Environmental Documents”. You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/.

2. In person . The Agency has established an official record for this action under docket control number PB-402404-IL. The official record consists of the documents specifically referenced in this action, this notice, the State of Illinois's authorization application, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The docket is located at the EPA Region V Office, Environmental Protection Agency, Waste, Pesticides and Toxics Division, Pesticides and Toxics Branch, Toxics Program Section, (DT-8J), 77 West Jackson Blvd, Chicago, IL 60604.

You may submit comments and hearing requests through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number PB-402404-IL in the subject line on the first page of your response.

1. By mail . Submit your comments and hearing requests to: Environmental Protection Agency, Region V, Waste, Pesticides and Toxics Division, Pesticides and Toxics Branch, (DT-8J), 77 West Jackson Blvd, Chicago, IL 60604.

2. In person or by courier . Deliver your comments and hearing requests to: Environmental Protection Agency, Waste, Pesticides and Toxics Division, Pesticides and Toxics Branch, (DT-8J), 77 West Jackson Blvd, Chicago, IL 60604. The regional office is open from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.

3. Electronically . You may submit your comments and hearing requests electronically by e-mail to: leonova.larisa@epamail.epa.gov or mail your computer disk to the address identified above. Do not submit any information electronically that you consider to be CBI. Electronic comments and hearing requests must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Comments and data and hearing requests will also be accepted on standard disks in WordPerfect 6.1/8.0 file format. All comments and hearing requests in electronic form must be identified by docket control number PB-402404-IL. Electronic comments and hearing requests may also be filed online at many Federal Depository Libraries.

Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person identified under FURTHER INFORMATION CONTACT .

The State of Illinois has provided a certification letter stating that its lead-based paint training and certification self-certified program meets the requirements for authorization of a State program under section 404 of TSCA and has requested final approval of the Illinois lead-based paint training and certification program. Therefore, pursuant to section 404 of TSCA, the program is deemed authorized as of the date of submission (i.e., October 12, 2001). If EPA subsequently finds that the program does not meet all the requirements for approval of a State program, EPA will work with the State to correct any deficiencies in order to approve the program. If the deficiencies are not corrected, a notice of disapproval will be issued in the Federal Register and a federal program will be implemented in the State.

Pursuant to section 404(b) of TSCA, 15 U.S.C. 2684(b), EPA provides notice and an opportunity for a public hearing on a State or Tribal program application before approving the application. Therefore, by this notice EPA is soliciting public comment on whether the Illinois application meets the requirements for EPA approval. This notice also provides an opportunity to request a public hearing on the application. If a hearing is requested and granted, EPA will issue a Federal Register notice announcing the date, time, and place of the hearing. EPA's final decision on the application will be published in the Federal Register .

On October 28, 1992, the Housing and Community Development Act of 1992, Public Law 102-550, became law. Title X of that statute was the Residential Lead-Based Paint Hazard Reduction Act of 1992. That Act amended TSCA,15 U.S.C. 2601 et seq., by adding Title IV (15 U.S.C. 2681-2692), titled “Lead Exposure Reduction.”

Section 402 of TSCA authorizes and directs EPA to promulgate final regulations governing lead-based paint activities in target housing, public and commercial buildings, bridges, and other structures. Those regulations are to ensure that individuals engaged in such activities are properly trained, that training programs are accredited, and that individuals engaged in these activities are certified and follow documented work practice standards. Under section 404 of TSCA, a State may seek authorization from EPA to administer and enforce its own lead-based paint activities program.

On August 29, 1996 (61 FR 45777) (FRL-5389-9), EPA promulgated final TSCA section 402/404 regulations governing lead-based paint activities in target housing and child-occupied facilities. Those regulations are codified at 40 CFR part 745, and allow both States and Indian Tribes to apply for program authorization. Pursuant to section 404(h) of TSCA, EPA is to establish the Federal program in any State or Tribal Nation without its own authorized program in place by August 31, 1998.

States and Tribes that choose to apply for program authorization must submit a complete application to the appropriate Regional EPA Office for review. Those applications will be reviewed by EPA within 180 days of receipt of the complete application. To receive EPA approval, a State or Tribe must demonstrate that its program is at least as protective of human health and the environment as the Federal program, and provides for adequate enforcement (section 404(b) of TSCA, 15 U.S.C. 2684(b)). EPA's regulations (40 CFR part 745, subpart Q) provide the detailed requirements a State or Tribal program must meet in order to obtain EPA approval.

A State may choose to certify that its lead-based paint activities program meets the requirements for EPA approval, by submitting a letter signed by the Governor or Attorney General stating that the program meets the requirements of section 404(b) of TSCA. Upon submission of such certification letter, the program is deemed authorized. This authorization becomes ineffective, however, if EPA disapproves the application or withdraws the program authorization.

The following summary of the State of Illinois proposed program has been provided by the applicant.

EPA issued correspondence to the Illinois Department of Public Health (“the Department”) dated May 6, 1999, which granted a 3-year interim approval of the Illinois Lead Poisoning Prevention Program. The interim approval authorized the Department to enforce the Illinois Lead Poisoning Prevention Act (LPPA), 410 ILCS 45, and Lead Poisoning Prevention Code (LPPC), 77 Ill Adm. Code 845, in lieu of the Federal program. The effective date of the interim approval was April 16, 1999 (published by EPA in the Federal Register of February 29, 2000 (65 FR 10787) (FRL-6399-4). As a condition of the interim approval, the Department was required to submit a request for full (final) approval of the Illinois Program at least 180 days prior to the expiration of the 3-year interim approval.

Illinois is hereby applying for final approval and authorization to enforce its Lead Poisoning Prevention Program (LPPA). The Department provided amended copies of the LPPA, and Lead Poisoning Prevention Act Code (LPPC), and the Program Policies that govern the administration of the program. Copies of the correspondence from the Illinois Attorney General's office indicating the inapplicability of the Illinois Environmental Audit Privilege Law to the Illinois Lead Poisoning Prevention Act and the U.S. EPA response accepting the opinion offered by the Illinois Attorney General's office were also included with this application. These materials resolve the only remaining issue dealing with the applicability of the Illinois Environmental Audit Privilege Law to the enforcement of the LPPA and LPPC. Some materials submitted with the original application have been updated and revised and are submitted with this application. They are described below and will augment parts of the Department's original application for authorization.

The Department implements the LPPA and Code in order to carry out lead abatement programs that are designed to diminish the incidence of lead intoxication. The primary goal of the Department's Lead Abatement Program is to protect the public's health, safety and environment by identifying lead-bearing substances which may be the source of exposure to lead in children and to ensure that lead hazards are managed, mitigated or abated through the administration and enforcement of the LPPA and the LPPC, promulgated pursuant to the LPPA. The LPPA and LPPC, originally passed in 1973, were last amended in August 2001. This enabled the Department to pursue expanded enforcement for violations of the LPPA and LPPC, including administrative fines against licensed professionals and firms for violations of the LPPA and LPPC.

Individuals seeking licensure by the State of Illinois in the abatement industry as a worker, supervisor, inspector and risk assessor must first make application to the Department. The application requires proof the individual has successfully completed an appropriate lead training course. The course and the course provider chosen by the applicant must be one that is approved by the Department and provides training comparable to 40 CFR 745.225 as provided in section 845.28 of the LPPC. All lead licenses expire annually. Application for renewal includes the successful completion of an approved refresher course that is specific to the lead field of interest every 3 years. Individuals or firms can also apply for a lead contractor's license. This requires proof that the applicant holds a certificate of financial responsibility in the form of liability insurance that specifically covers lead work. The applicant has a written standard operation procedure that includes medical monitoring and a respirator protection program as specified in the Occupational Safety and Health Administration (OSHA) regulations; (incorporated by reference in section 845.12 of the LPPC), the applicant provides a detailed description of all legal proceedings or claims filed against them concerning any lead mitigation or lead abatement activities; the applicant signs a statement that only licensed lead workers and lead supervisors will be used to conduct lead mitigation and lead abatement activities; and, that the applicant agrees to notify the Department before beginning any lead mitigation or lead abatement project. Although the contractor applicant is not required to successfully complete a lead abatement training course, the applicant needs to employ a licensed lead supervisor and must assure that all lead abatement workers will have a valid Illinois lead worker license and that a licensed lead supervisor will oversee the project and be on-site during lead mitigation or lead abatement activities. A contractor's license must be renewed annually. Reciprocal requests for any lead license may be submitted for review and will be considered on a case by-case-basis. If, upon review of the applicant's application, it is determined that the licensing state's lead program is at least as protective as the Illinois program, the Department will issue an appropriate license. Lists of all people conducting lead activities are maintained by the Department and are available to the public upon request.

Training course providers seeking approval from the State of Illinois for initial and refresher courses for lead worker, lead supervisor, lead inspector and lead risk assessor disciplines must first make application to the Department. The application packet includes a checklist of materials submitted along with other requirements that must be satisfied before approval can be granted. All approvals are renewed annually. Audits of courses are completed by Department staff and the training course provider is notified as to the results of the audit, the deficiencies observed, and whether the course was determined to be satisfactory or not satisfactory. Training courses found not to be satisfactory are issued a notice to correct the deficiencies together with a written explanation of the items that the Department expects the provider to correct before the next training course is scheduled. A list of approved training course providers is maintained by the Department and is made available to the public upon request. Illinois does not require the certification and licensure of the project designer discipline at this time. However, additional requirements have been established to prepare licensed lead supervisors for large-scale lead abatement projects as cited in 40 CFR 745.225(d)(4). The Department has statutory authority to adopt rules for lead-based paint activities in public and commercial buildings. Where EPA provides guidance under 40 CFR 745.230, the Department will establish rules which will govern such activities as necessary to maintain authorization.

Work practice standards are established in the Illinois LPPC and in the policies and procedures of the Department. The Department has incorporated in section 845.12 of the LPPC, the U.S. Department of Housing and Urban Development (HUD) Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing (1995 and 1997) to enhance the work and performance standards throughout the LPPC. All inspections and risk assessments are completed by individuals holding an appropriate inspector or risk assessor license issued by the Department. Inspections and risk assessments are to be performed per incorporated HUD Guidelines. Lead mitigation and lead abatement activities are performed only by individuals or firms who hold the appropriate lead contractor license issued by the Department. The lead contractor has the responsibility to utilize documented methodologies to ensure that work is performed effectively and in a manner that protects building occupants and workers, and complies with the requirements outlined in the HUD Guidelines and the LPPC requirements.

Complaint investigations, inspections, course audits and enforcement activities are accomplished by Department staff located in the central and regional offices and through delegate agency agreements with local health departments. Central office staff provides for the licensing of individuals that conduct all lead-based activities in the state. One administrative assistant, one office administrator and three office associates process all licensure application submitted to the Department. One office associate is dedicated to support the Department's third party examination process. The third party examination is administered by an environmental health specialist III. Compliance and enforcement activities are conducted by an environmental health specialist I. A public service administrator is directly responsible for the day-to-day lead program activities, overall management of all program activities, and maintaining and revising the LPPA, LPPC and program policies to ensure compliance with more stringent requirements and documented methodologies. The public service administrator also serves as the Department Radiation Safety Officer responsible for all radioactive material utilized by the Department for lead investigations. Eight regional program staff conduct inspections on a daily basis as well as approximately 90 licensed lead risk assessors that work within our lead program as delegate agents under contract to perform the required investigations in their respective counties or municipalities. Overall program direction is provided by a senior public service administrator in the central office. Funding is established through a mandate that provides a dedicated state fund for the lead program. Revenue from licensing and training course approval fees are also directed to that fund. Departmental policy and procedure manuals provide protocol to achieve all necessary aspects of the Illinois Lead Poisoning Prevention Program. In those policies, details of activities to be implemented, standard enforcement procedures and examples of required letters may be found. Enforcement is accomplished through administrative procedures that have been referenced in the LPPA and LPPC. Violations of the LPPA and LPPC are subject to enforcement by the State's Attorney in the respective county where the violation occurred, enforcement by the Illinois Attorney General's office, and enforcement through administrative fines and penalties by the Department.

The Department participates in Environmental Justice grants from EPA to provide education and information to people who would not normally receive information about the hazards of lead through normal media. Not-for-profit associations are provided grant funds to seek out parents of children who are likely to be exposed to lead and may not be aware of the hazards associated with lead or about how to prevent lead poisoning. Additionally, the Department or its agents provide consultative services and screening to high risk target populations within Illinois for lead poisoning.

The Illinois lead program administration and enforcement is the responsibility of the Illinois Department of Public Health.

The Illinois Environmental Protection Agency (IEPA) is responsible for administration and enforcement of hazardous waste disposal including the provisions of RCRA.

Illinois Department of Public Health, G. Michael Brandt, Chief Asbestos and Lead Section, Division of Environmental Health, 525 West Jefferson Street, Springfield, IL 62761, (217) 782-3517.

Illinois Department of Public Health, Ronald Brown, Chief, Division of Health Assessment and Screening, 535 West Jefferson Street, Springfield, IL 62761, (217) 782-1227.

Illinois Environmental Protection Agency, Connie Sullinger, Office of Chemical Safety, P.O. Box 19276, Springfield, IL 62794-9276, (217) 785-0830.

EPA is only responsible for environmental pollution control in those cases where contaminants cross the property line of the address where lead abatement or mitigation is taking place. This includes waste disposal as well as air and water pollution that may leave the property. Such issues involving waste disposal or pollutants are investigated jointly, or are referred to IEPA.

Section 404(b) of TSCA makes it unlawful for any person to violate, or fail or refuse to comply with, any requirement of an approved State or Tribal program. Therefore, EPA reserves the right to exercise its enforcement authority under TSCA against a violation of, or a failure or refusal to comply with, any requirement of an authorized State or Tribal program.

The Congressional Review Act, 5 U.S.C. 801 et seq. , as amended by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before certain actions may take effect, the agency promulgating the action must submit a report, which includes a copy of the action, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this document in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Title: Flood Insurance.

OMB Number: 3064-0120.

Frequency of Response: On occasion.

Affected Public: Any depository institution whose borrower's loan requests were secured by a building located on property in a special flood hazard area.

Estimated Number of Respondents/Recordkeepers: 5,700.

Estimated Number of Transactions: 180,000.

Estimated Reporting Hours: .05 hours × 180,000 = 9,000.

Estimated Recordkeeping Hours: 5,700 hours.

Estimated Total Annual Reporting and Recordkeeping Burden Hours: 5,700 + 9,000 = 14,700 hours.

General Description of Collection: Each supervised lending institution is currently required to provide a notice of special flood hazards to a borrower acquiring a loan secured by a building on real property located in an area identified by the Director of the Federal Emergency Management Administration as being subject to special flood hazards. The Riegle Community Development Act requires that each institution must also provide a copy of the notice to the servicer of the loan (if different from the originating lender).

Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the FDIC's functions, including whether the information has practical utility; (b) the accuracy of the estimates of the burden of the information collection, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

At the end of the comment period, the comments and recommendations received will be analyzed to determine the extent to which the collection should be modified prior to submission to OMB for review and approval. Comments submitted in response to this notice also will be summarized or included in the FDIC's requests to OMB for renewal of this collection. All comments will become a matter of public record.

Section 10(g)(1) of the Federal Home Loan Bank Act (Bank Act) requires the Finance Board to promulgate regulations establishing standards of community investment or service Bank members must meet in order to maintain access to long-term advances. See 12 U.S.C. 1430(g)(1). The regulations promulgated by the Finance Board must take into account factors such as the Bank member's performance under the Community Reinvestment Act of 1977 (CRA), 12 U.S.C. 2901 et seq. , and record of lending to first-time homebuyers. See 12 U.S.C. 1430(g)(2). Pursuant to the requirements of section 10(g) of the Bank Act, the Finance Board has promulgated a community support requirement regulation that establishes standards a Bank member must meet in order to maintain access to long-term advances, and review criteria the Finance Board must apply in evaluating a member's community support performance. See 12 CFR part 944. The regulation includes standards and criteria for the two statutory factors—CRA performance and record of lending to first-time homebuyers. 12 CFR 944.3. Only members subject to the CRA must meet the CRA standard. 12 CFR 944.3(b). All members, including those not subject to CRA, must meet the first-time homebuyer standard. 12 CFR 944.3(c).

Under the rule, the Finance Board selects approximately one-eighth of the members in each Bank district for community support review each calendar quarter. 12 CFR 944.2(a). The Finance Board will not review an institution's community support performance until it has been a Bank member for at least one year. Selection for review is not, nor should it be construed as, any indication of either the financial condition or the community support performance of the member.

Each Bank member selected for review must complete a Community Support Statement and submit it to the Finance Board by the February 28, 2002 deadline prescribed in this notice. 12 CFR 944.2(b)(1)(ii) and (c). On or before January 28, 2002, each Bank will notify the members in its district that have been selected for the 2000-01 eighth quarter community support review cycle that they must complete and submit to the Finance Board by the deadline a Community Support Statement. 12 CFR 944.2(b)(2)(i). The member's Bank will provide a blank Community Support Statement Form, which also is available on the Finance Board's web site: WWW.FHFB.GOV. Upon request, the member's Bank also will provide assistance in completing the Community Support Statement.

The Finance Board has selected the following members for the 2000-01 eighth quarter community support review cycle:

To encourage the submission of public comments on the community support performance of Bank members, on or before January 28, 2002, each Bank will notify its Advisory Council and nonprofit housing developers, community groups, and other interested parties in its district of the members selected for community support review in the 2000-01 eighth quarter review cycle. 12 CFR 944.2(b)(2)(ii). In reviewing a member for community support compliance, the Finance Board will consider any public comments it has received concerning the member. 12 CFR 944.2(d). To ensure consideration by the Finance Board, comments concerning the community support performance of members selected for the 2000-01 eighth quarter review cycle must be delivered to the Finance Board on or before the February 28, 2002 deadline for submission of Community Support Statements.

This final guidance document entitled “General Principles of Software Validation” provides guidance to medical device manufacturers and FDA staff concerning requirements for validating software used within medical devices, in device production, or in implementing the manufacturer's quality system. It replaces the draft guidance that FDA issued for comment on June 9, 1997, and published in the Federal Register of July 25, 1997 (62 FR 40099).

We received responses from 36 organizations and individuals, with more than 650 questions, comments, and specific recommendations for changes to the guidance. However, further work on the guidance was interrupted by other high priority activities, including implementation of the Food and Drug Administration Modernization Act of 1997, FDA's response to year 2000 software concerns, and two rounds of implementation of our first medical device performance standard. Because of the delay in issuing this final guidance, we have chosen to summarize our response to the comments received. As with any guidance, we will continue to accept comments and may update this document in the future.

The following summarizes the comments we received, and significant changes we made to the guidance in response to those comments:

From a few of the comments received, it appears that some parties may not have realized the full breadth of the quality system regulation. The software validation requirement in 21 CFR 820.70(i) of the quality system regulation also applies to automated tools used to design medical devices and tools used to develop software. Since the first medical device good manufacturing practice regulation was published in 1978, there has always been an explicit validation requirement for software used in device production or used to implement the quality system. When design controls were introduced into the quality system regulation in 1997, that software validation requirement was extended to software used to design devices, such as computer-aided design and software development tools. FDA clearly addressed this issue at the end of its response to comment 136 in the preamble to the quality system regulation (61 FR 52602 at 52630, October 7, 1996). A copy of the text is included at the end of this section.

Some comments objected to the discussion of validation activities during the predesign “concept” phase of software development, both because the quality system regulation does not apply to research activities, and because there is too little information available at that point to make any validation related activity worthwhile. In response to these concerns, we have removed all reference to validation activities during the “concept” phase.

Other comments noted that the guidance covered more than just validation issues, and suggested changing the title to broaden the scope of the guidance. We acknowledge that the scope of the guidance is somewhat broader than the scope of validation in the strictest definition of that term. However, we have chosen not to change the title of the guidance. Planning, verification, testing, traceability, configuration management, and many other activities discussed in the guidance are important activities that together help to support a final conclusion that software is validated.

Some comments expressed concerns that the guidance might be applied too rigorously by FDA investigators, and some pharmaceutical manufacturers raised questions about how the guidance would be applied to their drug manufacturing operations. The agency's good guidance practices (GGPs) clearly state the role of FDA guidance. Alternative approaches that accomplish full compliance with the quality system regulation are acceptable. While it is clearly intended for medical device manufacturers, the guidance may also be useful to the pharmaceutical industry and other industries regulated by FDA.

Many comments suggested that we move all discussions regarding use of off-the-shelf (OTS) software to the agency's guidance entitled “Off-the-Shelf Software Use in Medical Devices.” In response to these comments, specific cross references to that document have been added within the text of this guidance. However, the OTS guidance document deals specifically with premarket submissions for OTS software contained in medical devices. It is not the appropriate guidance for OTS software used in manufacturing and quality systems applications.

Numerous comments cited overly restrictive language and lack of sufficient implementation flexibility in the draft guidance. For example, many comments noted that the guidance implies use of a “waterfall” as the preferred life cycle development methodology. Several comments suggested that more discussion was needed regarding “rapid application development” and “component-based methodologies,” as well as “build a little/test a little” as an acceptable methodology. Other comments asked for specific examples of available life cycle models that could be used. In response to these comments, and in accordance with our own GGPs, we have carefully rewritten the text to remove any direct or implied use of the words “shall” or “must,” except where we describe or reference a regulation. We also have added language to specifically state that incremental development methodologies may be used, and that activities and tasks can be performed in a different order, if called for by the chosen life cycle model. However, for ease of description, we have retained an organization of activities based on “requirements,” “design,” “coding (or construction),” and “testing.” Regardless of the order in which tasks are accomplished, these four categories of activities are common to most life cycle models. We have not included examples of the dozens of life cycle models that are available. To do so could imply agency endorsement of certain life cycle models that are included over those models that are not included. Instead, you are referred to many of the textbooks and other references listed at the end of the guidance, which provide details of many of these life cycle models.

One group of comments objected to any use of the word “all” when describing items to be included in specification documents, noting that “all” is not a quantifiable term. Other comments suggested use of the word “may” rather than “should.” On the other hand, a few comments asked for a specific compliance matrix, so that manufacturers would know exactly how to comply with FDA expectations. We have not adopted these suggested changes. We believe that agency guidance should identify and encourage use of approaches known to have been used effectively, while the manufacturer retains the prerogative to choose alternative approaches that are equally effective. Based on variables such as firm size and structure, device risk, project size, and complexity, manufacturers have the flexibility to choose different approaches for different projects, and to select effective approaches that best fit their specific needs.

Several comments suggested use of the framework and format in international guidelines such as ISO 9000-3, GAMP, IEEE Software Standards and ISO/IEC 12207. We have drawn information from each of these sources and many other listed references, but unfortunately, there is no single format available. We have rewritten the guidance to address specific suggestions for wording changes and simpler language. Some comments asked for extensive use of charts, analogies, and examples for the concepts presented in the document. While valuable, such an approach could easily triple the size of the guidance. Instead, we suggest referring to any of the extensive list of references included at the end of the guidance for more details on specific implementation approaches.

Regarding the discussion of differences between hardware and software, the comments were somewhat divided. Some comments applauded the agency for recognizing the legitimate differences between hardware engineering and software engineering. Other comments argued that “software is not different” and suggested deletion of all or most of this section, either because it was unnecessary, or because it could be misinterpreted by software developers who lack sufficient engineering discipline. One comment suggested emphasizing the similarities of the engineering discipline needed to build both hardware and software. We have chosen to keep this section because we believe it explains part of the rationale for why software must be thoroughly validated, and why the software development process needs to be carefully controlled and managed. We have also added additional information regarding the impact of mobility of software professionals on the long-term maintenance of software and the need for thorough documentation.

Some comments objected to the discussion of standardization and reuse of software components and asked for more recognition of the trend toward increased use of OTS and component-based development methods. Other comments objected to the statement that “repairs made to correct software defects establish a new design.” We have revised the text to address both of these concerns.

We reorganized and rewrote the section regarding “Principles of Software Validation” to address the comments received. For example, we moved the subsection dealing with documenting software “Requirements” to the front of the section to reflect the importance of requirements in the validation process. We clarified language regarding “predetermined” requirements to allow for incremental or evolutionary development of requirements during the development project. However, we have retained the concept that documented requirements should be established prior to formal testing or other verification activities to provide “objective” evidence that those requirements were met.

The subsection previously entitled “Testing” is retitled “Defect Prevention” and is revised to emphasize the importance of preventing software defects, as opposed to trying to “test quality into” software.

We have renamed the subsection on “Timing.” In response to several comments concerning validation continuing “for the entire life cycle,” we have rewritten the text, but have retained the concept. At each stage of the software life cycle, there is information available that can contribute to a conclusion that the software meets user needs and intended uses. Therefore, the validation process does not end when the device is shipped.

We replaced the subsection on “Management” with a new subsection dealing with the “Software Life Cycle.”

We have clarified the subsections dealing with “Plans” and “Procedures” to distinguish between plans that define what to do, and procedures that describe how to do it.

The subsection entitled “Partial Validation” is substantially rewritten and retitled “Software Validation After a Change.” Many readers misinterpreted the statement that “software cannot be partially validated” and thought we intended all validation testing to be repeated every time any change is made. That is not what we meant. Based on the comments received, we have rewritten the discussion to emphasize the need for regression analysis after a change, followed by an appropriate level of regression testing to reestablish the validation status of the software. We have deleted specific discussion of retrospective validation and reverse engineering of nonvalidated software, but these issues should be covered during the regression analysis.

We have retitled and rewritten the subsection on “Amount of Effort.” Now titled “Validation Coverage,” it still describes an approach that ties the level of validation and verification effort to the safety risk and complexity of the software.

We revised the subsection on “Independence of Review” to provide greater flexibility and a better explanation of its intent.

The subsection previously entitled “Real World” is now entitled “Flexibility and Responsibility,” and reemphasizes that device manufacturers/software developers have a lot of flexibility in how they implement their software validation process, but the device manufacturer is ultimately responsible for the adequacy and effectiveness of the selected approach.

Some of the most significant comments we received had to do with our basic definition of software validation. In the previous draft guidance, we relied upon technical definitions used by the National Institute of Standards and Technology and by the Institute of Electrical and Electronic Engineers. These technical definitions created some confusion with other definitions in our quality system regulation. Numerous comments objected to our use of “validation” as an umbrella term to cover “design review” and “verification” as well as validation. They stated that both design review and verification are distinctly separable quality concepts and are not a part of validation. In response to these concerns, we have changed the definition of software validation to be more consistent with the quality system regulation and other international quality standards. Our revised definition of software validation is derived directly from the definitions of “validation” and “design validation” in the quality system regulation.

Comments also objected to the title “Typical Validation Tasks” at the end of each subsection in the section V of the guidance and suggested that they are really verification tasks. Other comments objected to possible interpretation of these as mandatory tasks. In response to these comments, we have also added text to explain that there are typical verification and testing tasks that support an overall conclusion that software is validated. Thereafter, when we discuss “Typical Tasks Supporting Validation,” we do not try to differentiate between verification tasks versus validation tasks. Instead, we have revised the text to list “Typical Tasks.” While we want to avoid any inference that the tasks are mandatory in every case, the guidance makes the point that these are “typical” approaches that are recommended by software engineering standards and textbooks, and widely used by many software engineering professionals.

Several comments noted inconsistencies in terminology from that contained in the quality system regulation, in two software guidances issued by the Office of Device Evaluation, and in the FDA glossary of computerized system and software development terminology. These comments also suggested use of the term “risk analysis” instead of “hazard analysis” throughout the software validation guidance. We have revised the guidance to incorporate the term “risk analysis” throughout. However, we continue to emphasize that while there are many different risks (e.g., economic or time to market), FDA is concerned about safety risk (hazard). At their next revision, we expect to update other software guidance documents and the FDA glossary with consistent definitions of validation, verification, and risk analysis. In addition, we now use the term “user site testing” rather than “installation testing” to describe testing performed at the user site and outside the control of the software manufacturer.

Some comments questioned whether OTS software could be validated because the device manufacturer frequently does not have access to the source code. These comments suggested that OTS software should be “qualified” rather than “validated.” However, we believe that the evidence developed by a device manufacturer concerning OTS software is a true validation because it directly supports a conclusion that the software meets user needs and intended uses. Where the source code is not available, it is incumbent upon the device manufacturer to use other means (such as audits, or more extensive black box testing) to infer the structural integrity of the OTS software. This issue is clearly addressed in comment 136 of the preamble to the quality system regulation (61 FR 52602 at 52630).

Other comments from the pharmaceutical industry suggested incorporation of widely understood process validation terminology (i.e., installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ)) to describe software validation. Another comment suggested use of “product performance qualification” rather than “design validation.” We have added a section that refers to the various types of qualification, but we have chosen not to adopt “qualification” terminology in explaining software validation requirements. Of course, manufacturers may continue to organize their validation efforts using IQ/OQ/PQ terminology, if they wish.

In response to comments, a new subsection has been added to explain the differences between “requirements,” which may be general in nature, versus “specifications,” which are developed to an engineering level of detail.

Several comments objected to use of undefined terms such as “microcode” and “assertions.” We reiterate that these and many other terms used throughout the guidance are specifically defined in the FDA glossary of computerized system and software development terminology, which is available at http://www.fda.gov/ora/inspect_ref/igs/gloss.html.