Pursuant to the Privacy Act (5 U.S.C. 552a), the USDA Forest Service is proposing to add a new system of records entitled USDA/FS-52, Resource Ordering and Status System (ROSS) that will automate an existing manual dispatch process for incident management. The ROSS database will identify, obligate, and report the status of individuals for wildland fire protection and other incident assignments. An estimated 200,000 individual records are expected to be collected in the system and stored in an automated database located at the National Information Technology Center in Kansas City, Missouri. The ROSS database may contain personal information about individuals who participate in wildland fire protection and other incident operations.

The USDA Forest Service is the administrative agency for this system, but it may be used by agencies that are members of the interagency National Wildfire Coordinating Group (NWCG) and its cooperators.

In accordance with the Privacy Act and Office of Management and Budget (OMB) Circular A-130, the USDA has provided a report of this new system of records to the OMB and to the Congress.

A copy of the new system of records is set out at the end of this notice. The USDA invites comments on all portions of this notice. Those who submit comments should be aware that all comments, including names and addresses, when provided, are placed in the record and are available for public inspection. Individuals wishing to inspect comments should call the Forest Service Freedom of Information Act and Privacy Act Office at (703) 605-4913 to make arrangements.

Title: Phytosanitary Export Certification.

OMB Number: 0579-0052.

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

Abstract: The Animal and Plant Health Inspection Service (APHIS), among other things, provides export certification services to assure other countries that the plants and plant products they are receiving from the United States are free of plant pests specified by the receiving country.

It should be noted that our regulations do not require that we engage in export certification activities. We perform this work as a service to exporters who are shipping plants or plant products to countries that require phytosanitary certification as a condition of entry.

To request that we perform a phytosanitary inspection, an exporter must complete and submit an Application for Inspection and Certification of Plants and Plant Products for Export (PPQ Form 572).

After assessing the condition of the plants or plant products intended for export ( i.e. , after conducting a phytosanitary inspection), an inspector (who may be an APHIS employee or a State or county plant regulatory official) will issue an internationally recognized phytosanitary certificate (PPQ Form 577), a phytosanitary certificate for reexport (PPQ Form 579), or an export certificate for processed plant products (PPQ Form 578).

These forms are critical to our ability to certify plants and plant products for export. Without them, we would be unable to conduct an export certification program.

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

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

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

(2) Evaluate the accuracy of our estimate of the burden of the 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 0.661286 hours per response.

Respondents: U.S. growers, shippers, and exporters; State and county plant health protection authorities.

Estimated annual number of respondents: 23,225.

Estimated annual number of responses per respondent: 39.0979.

Estimated annual number of responses: 908,050.

Estimated total annual burden on respondents: 600,481 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)

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

Title: Application for Inspection and Certification of Animal Byproducts.

OMB Number: 0579-0008.

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

Abstract: U.S. exporters who wish to export certain animal byproducts to other countries must, in some instances, furnish the importing country with certificates that have been issued or endorsed by Veterinary Services (VS) of the Animal and Plant Health Inspection Service, U.S. Department of Agriculture. VS Form 16-24, Application for Inspection and Certification of Animal Byproducts, is one such certificate. The form also serves as a written agreement under which the exporter pays for services we render in connection with documenting the certification statements required by the importing country.

The exporter provides VS with the information requested on VS Form 16-24, including a detailed description of the processing techniques that are used to make the product eligible to enter the importing country. VS uses this information to monitor and certify the processing techniques. After monitoring the processing technique, VS issues or endorses the certificate attesting to the class and quality of the products and that the products have been processed according to the conditions and requirements of the importing country.

Without this certification, the importing country would not accept the product, and the exporter would be unable to conduct business with that country. The use of VS Form 16-24 has no impact on animal disease prevention or eradication activities in the United States. The form was developed to meet the importation requirements of other countries.

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

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

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

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

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

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

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

Respondents: U.S. exporters of animal byproducts.

Estimated annual number of respondents: 10.

Estimated annual number of responses per respondent: 1.

Estimated annual number of responses: 10.

Estimated total annual burden on respondents: 5 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)

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

Title: National Woodland Owner Survey.

OMB Number: 0596-0078.

Expiration Date of Approval: December 31, 2004.

Type of Request: Reinstatement.

Abstract: The National Woodland Owner Survey (NWOS) will collect data to characterize and increase our understanding of private forest-land owners, the critical link between forests and society, in the United States; to determine the opportunities and constraints confronting private forest-land owners; and to facilitate the planning and implementation of forest policies and programs.

The Forest and Range Land Renewable Resources Planning Act of 1974 and the Forest and Range Land Renewable Resources Act of 1978 provide the Forest Service with the legal authority to conduct the NWOS. These acts assign responsibility for the inventory and assessment of forest and related renewable resources to the Forest Service. Additionally, the importance of an ownership survey in this inventory and assessment process is highlighted in Section 253(c) of the Agricultural Research, Extension, and Education Reform Act of 1998, and the recommendations of the Second Blue Ribbon Panel on the Forest Inventory and Analysis Program.

The Forest Service's Forest Inventory and Analysis (FIA) program has conducted the NWOS on a periodic basis since 1978. The NWOS collects information to help answer questions related to the characteristics of the landholdings and landowners, ownership objectives, the supply of timber and non-timber products, forest management practices, delivery of education and financial assistance, and the concerns/constraints perceived by the landowners. The information collected provides widely cited benchmarks of the private forest-land owners in the United States. These results have been used to assess the sustainability of forest resources at national, regional, and state levels; to implement and assess the success of forest-land owner assistance programs; and to answer a variety of questions with topics ranging from fragmentation to the economics of private timber production.

The respondents will be a statistically selected group of individuals, families, American Indian tribes, partnerships, corporations, nonprofit organizations, clubs, and other private groups that own forest land in the United States. This group will be selected by using public records to collect the names and addresses from a systematic set of points identified as forest land from across the country. The number of forest-land owners to be contacted in each state will be determined by the number of private forest-land owners and the sampling intensity.

Respondents will be asked to answer questions related to (1) The general characteristics of their forest land, (2) their reasons for owning it, (3) how they use and manage their forest land, (4) their concerns related to their forest land, (5) their intentions for the future of their forest land, and (6) demographic information.

As in past information collections, respondents will be asked to answer questions related to the characteristics of their landholdings, their reasons for owning forest-land, the supply of timber and non-timber products, forest management practices, delivery of education and financial assistance, the concerns/constraints perceived by the landowners, their intentions for their forest-land, and general demographics.

The information collection will collect data using a mixed-mode survey technique that will involve a self-administered mail questionnaire and telephone interviews. First, a prenotice letter or postcard will be sent to all potential respondents describing this information collection and why the information is being collected and why their assistance is needed. Second, a questionnaire with a cover letter will be mailed to the potential respondents. The cover letter will reiterate the purpose and importance of this information collection and provide the respondents with legally required information. Third, a reminder will be mailed to thank the respondents and encourage the non-respondents to respond. The last stage of the mail portion of the information collection will be mailing a second questionnaire and cover letter to those individuals who have yet to respond. Telephone interviews will be used for follow-up surveys of the non-respondents to maximize our response rate.

The Forest Service's Forest Inventory and Analysis Program (FIA) will administer the mail portion of this information collection. The telephone interview portion of the information collection will be implemented by the National Agricultural Statistics Service, U.S. Department of Agriculture. Data will be compiled and edited by FIA personnel.

FIA personnel will analyze the collected data. At a minimum, national and regional reports of the data will be distributed through print and electronic media. In addition, the data will be made available to the public. The publicly released data will be formatted to ensure the anonymity of the respondents.

This information collection will generate reliable and up-to-date information on private forest-land owners in the United States. The results of these efforts will provide more reliable information on this important and very dynamic segment of the United States population and facilitate more complete assessments of the country's forest resources and improved planning and implementation of forestry programs.

Estimate of Annual Burden: 15 minutes.

Type of Respondents: Individuals, families, American Indian tribes, partnerships, corporations, nonprofit organizations, clubs, and other private groups that own forest land.

Estimated Annual Number of Respondents: 10,000.

Estimated Annual Number of Responses per Respondent: 1.

Estimated Total Annual Burden on Respondents: 2,500 hours.

Comment is invited on: (1) Whether this collection of information is necessary for the stated purposes and the proper performance of the functions of the agency, including whether the information will have practical or scientific utility; (2) the accuracy of the agency's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including the use of automated, electronic, mechanical, or other technological collection techniques, or other forms of information technology.

All comments received in response to this notice, including names and addresses when provided, will be a matter of public record. Comments will be summarized and included in the submission for Office of Management and Budget approval.

On June 30, 2004, a notice was published in the Federal Register (69 FR 39401) announcing that the Forest Service intended to prepare an Environmental Impact Statement addressing the possible Federal action of preparing a plan for Gold Camp Road and inviting comments on the scope of the Environmental Impact Statement. Comments were received from April 12 through August 17, 2004 and were considered and are reflected in the Draft Plan/EIS made available for comment through this notice. This notice is provided pursuant to Forest Service regulations for implementing the National Environmental Policy Act of 1969 (40 CFR 1506.6).

The meeting is open to the public. Council discussion is limited to Forest Service staff and Council members; however, persons who wish to bring urban and community forestry matters to the attention of the Council may file written statements with the Council staff before or after the meeting. Public input sessions will be provided.

On August 19, 1993, the Department of Commerce (the Department) published an antidumping duty order on certain corrosion-resistant carbon steel flat products from Japan. See Antidumping Duty Orders: Certain Corrosion-Resistant Carbon Steel Flat Products From Japan , 58 FR 44163 (August 19, 1993). On October 5, 2004, SteelSummit International, Inc. (SteelSummit), an importer of certain corrosion-resistant carbon steel flat products (CORE) from Japan and an interested party in this proceeding, requested that the Department revoke the antidumping duty order on CORE from Japan with respect to nickel-plated steel foil through the initiation of a changed circumstances review.

According to SteelSummit, revocation with respect to nickel-plated steel foil is warranted because there is no longer any domestic interest in the continuation of the order with respect to the specified nickel-plated steel foil. The Department received letters from U.S. Steel Group (U.S. Steel) and International Steel Group (ISG) on November 1, 2004, and November 16, 2004, respectively, attesting to the lack of interest by the domestic industry regarding continuation of the order with respect to the nickel-plated steel foil specified in SteelSummit's changed circumstances request.

In response to SteelSummit's request and based on the information provided by U.S. Steel and ISG, on November 26, 2004, the Department simultaneously initiated a changed circumstances review and issued a notice of preliminary intent to revoke the order, in part (69 FR 68876). The Department provided interested parties an opportunity to comment on our preliminary intent to revoke the order, in part, with respect to nickel-plated steel foil. We did not receive any comments. Therefore, the final results of review are not different from the preliminary results and we are revoking the order, in part, with respect to certain nickel-plated steel foil as described in the “Scope of the Order” section of this notice.

The products subject to this order include flat-rolled carbon steel products, of rectangular shape, either clad, plated, or coated with corrosion-resistant metals such as zinc, aluminum, or zinc-, aluminum-, nickel- or iron-based alloys, whether or not corrugated or painted, varnished or coated with plastics or other nonmetallic substances in addition to the metallic coating, in coils (whether or not in successively superimposed layers) and of a width of 0.5 inch or greater, or in straight lengths which, if of a thickness less than 4.75 millimeters, are of a width of 0.5 inch or greater and which measures at least 10 times the thickness or if of a thickness of 4.75 millimeters or more are of a width which exceeds 150 millimeters and measures at least twice the thickness, as currently classifiable in the Harmonized Tariff Schedule under item numbers: 7210.30.0030, 7210.30.0060, 7210.41.0000, 7210.49.0030, 7210.49.0090, 7210.61.0000, 7210.69.0000, 7210.70.6030, 7210.70.6060, 7210.70.6090, 7210.90.1000, 7210.90.6000, 7210.90.9000, 7212.20.0000, 7212.30.1030, 7212.30.1090, 7212.30.3000, 7212.30.5000, 7212.40.1000, 7212.40.5000, 7212.50.0000, 7212.60.0000, 7215.90.1000, 7215.90.3000, 7215.90.5000, 7217.20.1500, 7217.30.1530, 7217.30.1560, 7217.90.1000, 7217.90.5030, 7217.90.5060, and 7217.90.5090.

Included in the order are flat-rolled products of nonrectangular cross-section where such cross-section is achieved subsequent to the rolling process ( i.e. , products which have been “worked after rolling”)—for example, products which have been bevelled or rounded at the edges.

Excluded from the scope of the order are flat-rolled steel products either plated or coated with tin, lead, chromium, chromium oxides, both tin and lead (“terne plate”), or both chromium and chromium oxides (“tin-free steel”), whether or not painted, varnished or coated with plastics or other nonmetallic substances in addition to the metallic coating. Also excluded from the scope of the order are certain clad stainless flat-rolled products, which are three-layered corrosion-resistant carbon steel flat-rolled products less than 4.75 millimeters in composite thickness that consist of a carbon steel flat-rolled product clad on both sides with stainless steel in a 20%-60%-20% ratio. See Antidumping Duty Orders: Certain Corrosion-Resistant Carbon Steel Flat Products From Japan, 58 FR 44163 (August 19, 1993).

Also excluded from the scope of this order are imports of certain corrosion-resistant carbon steel flat products meeting the following specifications: Widths ranging from 10 millimeters (0.394 inches) through 100 millimeters (3.94 inches); thicknesses, including coatings, ranging from 0.11 millimeters (0.004 inches) through 0.60 millimeters (0.024 inches); and a coating that is from 0.003 millimeters (0.00012 inches) through 0.005 millimeters (0.000196 inches) in thickness and that is comprised of three evenly applied layers, the first layer consisting of 99% zinc, 0.5% cobalt, and 0.5% molybdenum, followed by a layer consisting of chromate, and finally a layer consisting of silicate. See Certain Corrosion-Resistant Carbon Steel Flat Products From Japan: Final Results of Changed Circumstances Antidumping Duty Administrative Review, and Revocation in Part of Antidumping Duty Order, 62 FR 66848 (December 22, 1997).

Also excluded from the scope of this order are imports of subject merchandise meeting all of the following criteria: (1) Widths ranging from 10 millimeters (0.394 inches) through 100 millimeters (3.94 inches); (2) thicknesses, including coatings, ranging from 0.11 millimeters (0.004 inches) through 0.60 millimeters (0.024 inches); and (3) a coating that is from 0.003 millimeters (0.00012 inches) through 0.005 millimeters (0.000196 inches) in thickness and that is comprised of either two evenly applied layers, the first layer consisting of 99% zinc, 0.5% cobalt, and 0.5% molybdenum, followed by a layer consisting of chromate, or three evenly applied layers, the first layer consisting of 99% zinc, 0.5% cobalt, and 0.5% molybdenum followed by a layer consisting of chromate, and finally a layer consisting of silicate. See Certain Corrosion-Resistant Carbon Steel Flat Products From Japan: Final Results of Changed Circumstances Antidumping Duty Administrative Review, and Revocation in Part of Antidumping Duty Order, 64 FR 14861 (March 29, 1999).

Also excluded from the scope of this order are: (1) Carbon steel flat products measuring 1.84 mm in thickness and 43.6 mm or 16.1 mm in width consisting of carbon steel coil (SAE 1008) clad with an aluminum alloy that is balance aluminum, 20% tin, 1% copper, 0.3% silicon, 0.15% nickel, less than 1% other materials and meeting the requirements of SAE standard 783 for Bearing and Bushing Alloys; and (2) carbon steel flat products measuring 0.97 mm in thickness and 20 mm in width consisting of carbon steel coil (SAE 1008) with a two-layer lining, the first layer consisting of a copper-lead alloy powder that is balance copper, 9% to 11% tin, 9% to 11% lead, less than 1% zinc, less than 1% other materials and meeting the requirements of SAE standard 792 for bearing and bushing alloys, the second layer consisting of 45% to 55% lead, 38% to 50% PTFE, 3% to 5% molybdenum disulfide and less than 2% other materials. See Certain Corrosion-Resistant Carbon Steel Flat Products From Japan: Final Results of Changed Circumstances Review, and Revocation in Part of Antidumping Duty Order , 64 FR 57032 (October 22, 1999).

Also excluded from the scope of the order are imports of doctor blades meeting the following specifications: Carbon steel coil or strip, plated with nickel phosphorous, having a thickness of 0.1524 millimeters (0.006 inches), a width between 31.75 millimeters (1.25 inches) and 50.80 millimeters (2.00 inches), a core hardness between 580 to 630 HV, a surface hardness between 900-990 HV; the carbon steel coil or strip consists of the following elements identified in percentage by weight: 0.90% to 1.05% carbon; 0.15% to 0.35% silicon; 0.30% to 0.50% manganese; less than or equal to 0.03% of phosphorous; less than or equal to 0.006% of sulfur; other elements representing 0.24%; and the remainder of iron. See Certain Corrosion-Resistant Carbon Steel Flat Products From Japan: Final Results of Changed Circumstances Review, and Revocation in Part of Antidumping Duty Order, 65 FR 53983 (September 6, 2000).

Also excluded from the scope of the order are imports of carbon steel flat products meeting the following specifications: Carbon steel flat products measuring 1.64 millimeters in thickness and 19.5 millimeters in width consisting of carbon steel coil (SAE 1008) with a lining clad with an aluminum alloy that is balance aluminum; 10 to 15% tin; 1 to 3% lead; 0.7 to 1.3% copper; 1.8 to 3.5% silicon; 0.1 to 0.7% chromium; less than 1% other materials and meeting the requirements of SAE standard 783 for Bearing and Bushing Alloys. See Certain Corrosion-Resistant Carbon Steel Flat Products From Japan: Final Results of Changed Circumstances Review, and Revocation in Part of Antidumping Duty Order, 66 FR 8778 (February 2, 2001).

Also excluded from the scope of the order are carbon steel flat products meeting the following specifications: (1) Carbon steel flat products measuring 0.975 millimeters in thickness and 8.8 millimeters in width consisting of carbon steel coil (SAE 1012) clad with a two-layer lining, the first layer consisting of a copper-lead alloy powder that is balance copper, 9%-11% tin, 9%-11% lead, maximum 1% other materials and meeting the requirements of SAE standard 792 for Bearing and Bushing Alloys, the second layer consisting of 13%-17% carbon, 13%-17% aromatic polyester, with a balance (approx. 66%-74%) of polytetrafluorethylene (PTFE); and (2) carbon steel flat products measuring 1.02 millimeters in thickness and 10.7 millimeters in width consisting of carbon steel coil (SAE 1008) with a two-layer lining, the first layer consisting of a copper-lead alloy powder that is balance copper, 9%-11% tin, 9%-11% lead, less than 0.35% iron, and meeting the requirements of SAE standard 792 for bearing and bushing alloys, the second layer consisting of 45%-55% lead, 3%-5% molybdenum disulfide, with a balance (approx. 40%-52%) of polytetrafluorethylene (PTFE). See Certain Corrosion-Resistant Carbon Steel Flat Products From Japan: Notice of Final Results of Changed Circumstances Review, and Revocation in Part of Antidumping Duty Order, 66 FR 15075 (March 15, 2001).

Also excluded from this order are products meeting the following specifications: Carbon steel coil or strip, measuring 1.93 millimeters or 2.75 millimeters (0.076 inches or 0.108 inches) in thickness, 87.3 millimeters or 99 millimeters (3.437 inches or 3.900 inches) in width, with a low carbon steel back comprised of: Carbon under 8%, manganese under 0.4%, phosphorous under 0.04%, and sulfur under 0.05%; clad with aluminum alloy comprised of: 0.7% copper, 12% tin, 1.7% lead, 0.3% antimony, 2.5% silicon, 1% maximum total other (including iron), and remainder aluminum. Also excluded from this order are products meeting the following specifications: Carbon steel coil or strip, clad with aluminum, measuring 1.75 millimeters (0.069 inches) in thickness, 89 millimeters or 94 millimeters (3.500 inches or 3.700 inches) in width, with a low carbon steel back comprised of: Carbon under 8%, manganese under 0.4%, phosphorous under 0.04%, and sulfur under 0.05%; clad with aluminum alloy comprised of: 0.7% copper, 12% tin, 1.7% lead, 2.5% silicon, 0.3% antimony, 1% maximum total other (including iron), and remainder aluminum. See Certain Corrosion-Resistant Carbon Steel Flat Products From Japan: Notice of Final Results of Changed Circumstances Review, and Revocation in Part of Antidumping Duty Order, 66 FR 20967 (April 26, 2001).

Also excluded from this order are products meeting the following specifications: Carbon steel coil or strip, measuring a minimum of and including 1.10mm to a maximum of and including 4.90mm in overall thickness, a minimum of and including 76.00mm to a maximum of and including 250.00mm in overall width, with a low carbon steel back comprised of: Carbon under 0.10%, manganese under 0.40%, phosphorous under 0.04%, sulfur under 0.05%, and silicon under 0.05%; clad with aluminum alloy comprised of: Under 2.51% copper, under 15.10% tin, and remainder aluminum as listed on the mill specification sheet. See Certain Corrosion-Resistant Carbon Steel Flat Products From Japan: Notice of Final Results of Changed Circumstances Review, and Revocation in Part of Antidumping Duty Order, 67 FR 7356 (February 19, 2002).

Also excluded from this order are products meeting the following specifications: (1) Diffusion annealed, non-alloy nickel-plated carbon products, with a substrate of cold-rolled battery grade sheet (“CRBG”) with both sides of the CRBG initially electrolytically plated with pure, unalloyed nickel and subsequently annealed to create a diffusion between the nickel and iron substrate, with the nickel plated coating having a thickness of 0-5 microns per side with one side equaling at least 2 microns; and with the nickel carbon sheet having a thickness of from 0.004” (0.10mm) to 0.030” (0.762mm) and conforming to the following chemical specifications (%): C <= 0.08; Mn <= 0.45; P <= 0.02; S <= 0.02; Al <= 0.15; and Si <= 0.10; and the following physical specifications: Tensile = 65 KSI maximum; Yield = 32-55 KSI; Elongation = 18% minimum (aim 34%); Hardness = 85-150 Vickers; Grain Type = Equiaxed or Pancake; Grain Size (ASTM) = 7-12; Delta r value = aim less than +/-0.2; Lankford value = <== 1.2.; and (2) next generation diffusion-annealed nickel plate meeting the following specifications: (a) Nickel-graphite plated, diffusion annealed, tin-nickel plated carbon products, with a natural composition mixture of nickel and graphite electrolytically plated to the top side of diffusion annealed tin-nickel plated carbon steel strip with a cold rolled or tin mill black plate base metal conforming to chemical requirements based on AISI 1006; having both sides of the cold rolled substrate electrolytically plated with natural nickel, with the top side of the nickel plated strip electrolytically plated with tin and then annealed to create a diffusion between the nickel and tin layers in which a nickel-tin alloy is created, and an additional layer of mixture of natural nickel and graphite then electrolytically plated on the top side of the strip of the nickel-tin alloy; having a coating thickness: Top side: nickel-graphite, tin-nickel layer <== 1.0 micrometers; tin layer only <== 0.05 micrometers, nickel-graphite layer only <= 0.2 micrometers, and bottom side: Nickel layer <== 1.0 micrometers; (b) nickel-graphite, diffusion annealed, nickel plated carbon products, having a natural composition mixture of nickel and graphite electrolytically plated to the top side of diffusion annealed nickel plated steel strip with a cold rolled or tin mill black plate base metal conforming to chemical requirements based on AISI 1006; with both sides of the cold rolled base metal initially electrolytically plated with natural nickel, and the material then annealed to create a diffusion between the nickel and the iron substrate; with an additional layer of natural nickel-graphite then electrolytically plated on the top side of the strip of the nickel plated steel strip; with the nickel-graphite, nickel plated material sufficiently ductile and adherent to the substrate to permit forming without cracking, flaking, peeling, or any other evidence of separation; having a coating thickness: top side: nickel-graphite, tin-nickel layer <== 1.0 micrometers; nickel-graphite layer <== 0.5 micrometers; bottom side: nickel layer <== 1.0 micrometers; (c) diffusion annealed nickel-graphite plated products, which are cold-rolled or tin mill black plate base metal conforming to the chemical requirements based on AISI 1006; having the bottom side of the base metal first electrolytically plated with natural nickel, and the top side of the strip then plated with a nickel-graphite composition; with the strip then annealed to create a diffusion of the nickel-graphite and the iron substrate on the bottom side; with the nickel-graphite and nickel plated material sufficiently ductile and adherent to the substrate to permit forming without cracking, flaking, peeling, or any other evidence of separation; having coating thickness: top side: nickel-graphite layer <== 1.0 micrometers; bottom side: nickel layer <== 1.0 micrometers; (d) nickel-phosphorous plated diffusion annealed nickel plated carbon product, having a natural composition mixture of nickel and phosphorus electrolytically plated to the top side of a diffusion annealed nickel plated steel strip with a cold rolled or tin mill black plate base metal conforming to the chemical requirements based on AISI 1006; with both sides of the base metal initially electrolytically plated with natural nickel, and the material then annealed to create a diffusion of the nickel and iron substrate; another layer of the natural nickel-phosphorous then electrolytically plated on the top side of the nickel plated steel strip; with the nickel-phosphorous, nickel plated material sufficiently ductile and adherent to the substrate to permit forming without cracking, flaking, peeling or any other evidence of separation; having a coating thickness: top side: nickel-phosphorous, nickel layer <== 1.0 micrometers; nickel-phosphorous layer <== 0.1 micrometers; bottom side : nickel layer <== 1.0 micrometers; (e) diffusion annealed, tin-nickel plated products, electrolytically plated with natural nickel to the top side of a diffusion annealed tin-nickel plated cold rolled or tin mill black plate base metal conforming to the chemical requirements based on AISI 1006; with both sides of the cold rolled strip initially electrolytically plated with natural nickel, with the top side of the nickel plated strip electrolytically plated with tin and then annealed to create a diffusion between the nickel and tin layers in which a nickel-tin alloy is created, and an additional layer of natural nickel then electrolytically plated on the top side of the strip of the nickel-tin alloy; sufficiently ductile and adherent to the substrate to permit forming without cracking, flaking, peeling or any other evidence of separation; having coating thickness: Top side: nickel-tin-nickel combination layer <== 1.0 micrometers; tin layer only <== 0.05 micrometers; bottom side: nickel layer <== 1.0 micrometers; and (f) tin mill products for battery containers, tin and nickel plated on a cold rolled or tin mill black plate base metal conforming to chemical requirements based on AISI 1006; having both sides of the cold rolled substrate electrolytically plated with natural nickel; then annealed to create a diffusion of the nickel and iron substrate; then an additional layer of natural tin electrolytically plated on the top side; and again annealed to create a diffusion of the tin and nickel alloys; with the tin-nickel, nickel plated material sufficiently ductile and adherent to the substrate to permit forming without cracking, flaking, peeling or any other evidence of separation; having a coating thickness: top side: nickel-tin layer <== 1 micrometer; tin layer alone <== 0.05 micrometers; bottom side: nickel layer <== 1.0 micrometer. See Certain Corrosion-Resistant Carbon Steel Flat Products From Japan: Notice of Final Results of Changed Circumstances Review, and Revocation in Part of Antidumping Duty Order, 67 FR 47768 (July 22, 2002).

Also excluded from this order are products meeting the following specifications: (1) Widths ranging from 10 millimeters (0.394 inches) through 100 millimeters (3.94 inches); (2) thicknesses, including coatings, ranging from 0.11 millimeters (0.004 inches) through 0.60 millimeters (0.024 inches); and (3) a coating that is from 0.003 millimeters (0.00012 inches) through 0.005 millimeters (0.000196 inches) in thickness and that is comprised of either two evenly applied layers, the first layer consisting of 99% zinc, 0.5% cobalt, and 0.5% molybdenum, followed by a layer consisting of phosphate, or three evenly applied layers, the first layer consisting of 99% zinc, 0.5% cobalt, and 0.5% molybdenum followed by a layer consisting of phosphate, and finally a layer consisting of silicate. See Certain Corrosion-Resistant Carbon Steel Flat Products From Japan: Notice of Final Results of Changed Circumstances Review, and Revocation in Part of Antidumping Duty Order, 67 FR 57208 (September 9, 2002).

Also excluded from this order are products meeting the following specifications: (1) Flat-rolled products (provided for in HTSUS subheading 7210.49.00), other than of high-strength steel, known as “ASE Iron Flash” and either: (A) Having a base layer of zinc-based zinc-iron alloy applied by hot-dipping and a surface layer of iron-zinc alloy applied by electrolytic process, the weight of the coating and plating not over 40 percent by weight of zinc; or (B) two-layer-coated corrosion-resistant steel with a coating composed of (a) a base coating layer of zinc-based zinc-iron alloy by hot-dip galvanizing process, and (b) a surface coating layer of iron-zinc alloy by electro-galvanizing process, having an effective amount of zinc up to 40 percent by weight, and (2) corrosion resistant continuously annealed flat-rolled products, continuous cast, the foregoing with chemical composition (percent by weight): Carbon not over 0.06 percent by weight, manganese 0.20 or more but not over 0.40, phosphorus not over 0.02, sulfur not over 0.023, silicon not over 0.03, aluminum 0.03 or more but not over 0.08, arsenic not over 0.02, copper not over 0.08 and nitrogen 0.003 or more but not over 0.008; and meeting the characteristics described below: (A) Products with one side coated with a nickel-iron-diffused layer which is less than 1 micrometer in thickness and the other side coated with a two-layer coating composed of a base nickel-iron-diffused coating layer and a surface coating layer of annealed and softened pure nickel, with total coating thickness for both layers of more than 2 micrometers; surface roughness (RA-microns) 0.18 or less; with scanning electron microscope (SEM) not revealing oxides greater than 1 micron; and inclusion groups or clusters shall not exceed 5 microns in length; (B) products having one side coated with a nickel-iron-diffused layer which is less than 1 micrometer in thickness and the other side coated with a four-layer coating composed of a base nickel-iron-diffused coating layer; with an inner middle coating layer of annealed and softened pure nickel, an outer middle surface coating layer of hard nickel and a topmost nickel-phosphorus-plated layer; with combined coating thickness for the four layers of more than 2 micrometers; surface roughness (RA-microns) 0.18 or less; with SEM not revealing oxides greater than 1 micron; and inclusion groups or clusters shall not exceed 5 microns in length; (C) products having one side coated with a nickel-iron-diffused layer which is less than 1 micrometer in thickness and the other side coated with a three-layer coating composed of a base nickel-iron-diffused coating layer, with a middle coating layer of annealed and softened pure nickel and a surface coating layer of hard, luster-agent-added nickel which is not heat-treated; with combined coating thickness for all three layers of more than 2 micrometers; surface roughness (RA-microns) 0.18 or less; with SEM not revealing oxides greater than 1 micron; and inclusion groups or clusters shall not exceed 5 microns in length; or (D) products having one side coated with a nickel-iron-diffused layer which is less than 1 micrometer in thickness and the other side coated with a three-layer coating composed of a base nickel-iron-diffused coating layer, with a middle coating layer of annealed and softened pure nickel and a surface coating layer of hard, pure nickel which is not heat-treated; with combined coating thickness for all three layers of more than 2 micrometers; surface roughness (RA-microns) 0.18 or less; SEM not revealing oxides greater than 1 micron; and inclusion groups or clusters shall not exceed 5 microns in length. See Certain Corrosion-Resistant Carbon Steel Flat Products From Japan: Notice of Final Results of Changed Circumstances Review, and Revocation in Part of Antidumping Duty Order, 68 FR 19970 (April 23, 2003).

As a result of this review, also excluded from the scope of this order is merchandise meeting the following specifications:

Pursuant to sections 751(d)(1) and 782(h)(2) of the Tariff Act of 1930, as amended (the Act), the Department may revoke an antidumping or countervailing duty order based on a review under section 751(b) of the Act ( i.e. , a changed circumstances review). Section 751(b)(1) of the Act requires a changed circumstances review to be conducted upon receipt of a request which shows changed circumstances sufficient to warrant a review.

In this case, based on the information provided by SteelSummit, and comments from U.S. Steel and ISG, the Department preliminarily found that the continued relief provided by the order with respect to nickel-plated steel foil from Japan is no longer of interest to the domestic industry. We did not receive any comments. Therefore, the Department is revoking the order on CORE from Japan with regard to the products that meet the specifications detailed above.

We will instruct U.S. Customs and Border Protection (CBP) to liquidate without regard to antidumping duties all unliquidated entries of nickel-plated steel foil not subject to final results of an administrative review. The Department will further instruct CBP to refund with interest any estimated antidumping duties collected with respect to unliquidated entries of nickel-plated steel foil entered, or withdrawn from warehouse for consumption on or after the publication date of the final results of this changed circumstances review, in accordance with section 778 of the Act and 19 CFR 351.222(g)(4).

This changed circumstances administrative review, partial revocation of the antidumping duty order and notice are in accordance with sections 751(b) and (d) and 782(h) of the Act and section 351.216(e) and 351.222(g) of the Department's regulations.

On behalf of the Department of Homeland Security, the National Institute of Standards and Technology (NIST) is coordinating performance tests of commercially available equipment based on the ANSI N42.32, N42.33, N42.34 and N42.35 standards as well as on the test and evaluation protocols for the Department of Homeland Security (DHS) by various National laboratories. The tests are designed to determine the effectiveness of radiation detection instruments that may be used by first responders in a radiological incident. The participating National laboratories are: Oak Ridge National Laboratory (ORNL), Pacific Northwest National Laboratory (PNNL), Los Alamos National Laboratory (LANL) and Lawrence Livermore National Laboratory (LLNL).

Interested manufacturers should contact NIST at the address given above. NIST will supply a Letter of Understanding, which the manufacturer must execute and send to NIST. NIST will then assign the manufacturer's equipment to the National laboratory conducting the testing for that type of device and will provide the manufacturer with shipping instructions for their equipment. All equipment tested under this program must meet the minimum specifications stated in ANSI Standards N42.32 “Performance Criteria for Alarming Personal Radiation Detectors for Homeland Security,” N42.33 “Portable Radiation Detection Instrumentation for Homeland Security,” N42.34 “Performance Criteria for Hand-held Instruments for the Detection and Identification of Radionuclides,” and N42.35 “Evaluation and Performance of Radiation Detection Portal Monitors for Use in Homeland Security,” as detailed below.

The instruments provided will be tested according to the provisions in the standards and will be returned to the manufacturer after the tests by the National laboratory that performed the tests. Manufacturers should be aware that some of the testing protocols may damage or destroy the equipment. At the conclusion of the testing, the equipment will be returned to the Manufacturer, c.o.d., in the condition the equipment is in at the conclusion of the testing. Neither NIST, the Department of Homeland Security, nor any National laboratory will be responsible for the condition of the equipment when returned to the manufacturer. As a condition for participating in this testing program, each manufacturer must agree in advance to hold harmless all of these parties for the condition of the equipment.

The information acquired during the tests will be compiled by the Department of Homeland Security (DHS) and will be copied to the manufacturer for their instruments. A summary of the results of equipment testing will be made publicly available. Manufacturers who do not want the results of the testing of their equipment to be made publicly available should not participate in this program.

Participating manufacturers must provide three units of each instrument model. For portal monitors, two units of each instrument model are required. Manufacturers will pay all shipping costs, but there is no cost to the manufacturer for the testing. For the results to be valid two out of three submitted instruments per model must be operational for all tests. No modifications to the instruments are permitted during the testing process. Only calibrated instruments will be accepted for the testing program.

The types of instruments and preliminary specifications for each type are as follows:

Alarming personal radiation devices designed to detect low levels of radiation and alert the wearer with a visible, audible or vibratory alarm. They are not to be electronic dosimeters, radiation survey meters or other instruments designed for health physics use. If submitted for testing under this category, electronic dosimeters, survey meters, and similar health physics instruments will be returned to the manufacturer without testing.

• Personal sized (less than 20×10× 5 cm and less than 400 g).

• Capable of detecting photon exposure rates from approximately 10 to 3000 micro R/h.

• Capable of detecting photon energies from approximately 10 to 1000 keV.

• Capable of photon exposure rate measurements with ±30% accuracy.

• Audible, visible and/or vibratory alarm less than 2 seconds after detection.

• Optional response to neutrons.

• Mean time to false alarm greater than 1 hour.

• Capable of normal operation over temperature range from −20 °C to +50 °C and humidity from 40% to 93%.

• Unaffected by RF from 20 MHz to 1000 MHz, magnetic fields of 1 mT and electrostatic discharges of 6-8 kV.

Portable radiation detection instrumentation equipped with gamma- and x-ray detectors. The instruments shall be able to determine exposure rate and be equipped with alarming capabilities. The survey meters should be submitted either as a Type 1 or a Type 2 instrument according to standard N42.33 specifications. If submitted for testing under this category, electronic dosimeters, and personal radiation devices instruments will be returned to the manufacturer without testing.

• Storage space less than 1 ft 3 excluding extendable probes.

• Weight less than 10 pounds (4.55 kg).

• Outer instrument case shall be rigid, shock resistant, splash proof and dust resistant.

• Capable of detecting photon exposure rates from approximately 1 to 1000 micro R/h (that can be achieved with several probes).

• Storage space less than 0.12  3 excluding extendable probes.

• Weight less than 6 pounds (2.7 kg).

• Outer instrument case shall be rigid, shockproof, waterproof (blowing rain) and dust proof.

• Capable of detecting photon exposure rates from approximately 100 micro R/h to 1000 R/h (that can be achieved with several probes).

• Displays and alarm indications shall be oriented towards the user.

• The instrument case shall be constructed of materials that provide easy decontamination for radioactive materials and other potential surface contaminants.

• Capable of photon exposure rate measurements with ±30% accuracy.

• Instruments shall allow the user to set exposure rate alarm levels.

• Instruments shall indicate at least the following faults: low battery supply; detector failure; and high exposure rate level.

• Batteries shall provide at least 12 hours of continuous use under standard test conditions, i.e. , the response of the instrument shall remain unchanged.

• Response time to increase or decrease in exposure rate display (indication of less than 20% from actual exposure rate value) shall be within 4 seconds.

• Instruments readout shall remain “off-scale” for exposure rates greater than the maximum value of the instrument range

• Capable of normal operation over temperature range from −20 °C to +50 °C and humidity from 40% to 93%.

• Instruments shall be unaffected by RF interference from 20 MHz to 1000 MHz, magnetic fields of 1 mT, and electrostatic discharges of 6-8 kV.

Hand-held instruments for the detection and identification of radionuclides. These instruments shall provide gamma exposure or dose rate measurements, radionuclide identification, and be equipped with indication of neutron radiation. If submitted for testing under this category, instruments that are not equipped with gamma-ray and neutron detectors will be returned to the manufacturer without testing.

• Equipped with neutron detector.

• Capable of detecting photon energies from approximately 25 to 3000 keV.

• The instrument shall have the ability to transfer data to an external device, such as a computer.

• The instrument shall include: a display that is easily readable over the required temperature range and under different lighting conditions, controls that are user-friendly for routine operation, a menu structure that is simple and easy to be followed intuitively, and a user-definable radionuclide library with access via the restricted mode. The instrument shall have at least two different operating modes, one mode for routine operation and the other as a restricted (password protected) mode. The instrument shall be capable of operation if the user is wearing gloves or if the instrument is enclosed in anti-contamination protection ( e.g. , plastic bag).

• Instruments shall be designed to prevent water ingress from rain, condensing moisture, or high humidity.

• Batteries shall be such that they provide operation for a minimum of 2 hours of continuous use.

• Capable of normal operation over temperature range from − 20 °C to +50 °C and humidity from 40% to 93%.

• Unaffected by RF from 20 MHz to 1000 MHz, magnetic fields of 1 mT and electrostatic discharges of 6-8 kV.

Fixed or Transportable portal monitor systems. These types of monitors include fixed or transportable systems used for detection of radioactive materials concealed in people, packages and vehicles (including rail vehicles). These systems shall be capable of detecting gamma-rays emitted from radioactive sources; neutron detection is optional for all models except for vehicle monitoring. If portal monitors for vehicles are submitted for testing without neutron detection capabilities, instruments will be returned to the manufacturer without testing.

• Pedestrian, vehicles, rail vehicles and package monitors equipped with gamma-ray detection are accepted for testing.

• Vehicle monitors shall be equipped with neutron detectors.

• Instruments shall communicate, save and store time history data for later retrieval including background readings prior to and/or after an alarm, alarm information shall include time and date.

• Monitor shall be capable of providing local indication and alarm signals (these signals should be available at a remote station at a distance of at least 50 m).

• Monitors shall continuously indicate its operational or non-operational condition.

• Capable of normal operation over temperature range from − 30 °C to +55 °C and humidity from 10% to 93%.

• Unaffected by RF from 20 MHz to 1000 MHz, magnetic fields of 1 mT and electrostatic discharges of 6-8 kV.

Regulations at 50 CFR 622.6 and 640.6 require that all vessels with Federal permits to fish in the Southeast, and all vessels that fish for or possess shrimp in the Gulf, Exclusive Economic Zone (EEZ), display the vessel's official number and, additionally, those vessels with fish traps must display its traps' color codes. The numbers and colors codes must be in a specific size and displayed on the port and starboard sides of the deckhouse or hull and on a weather deck. The display of the identifying number and color-codes aids in fishery law enforcement.

No information is collected.

OMB Number: 0648-0358.

Form Number: None.

Type of Review: Regular submission.

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

Estimated Number of Respondents: 8,043.

Estimated Time Per Response: 45 minutes (15 minutes for each of three markings) for fishing and shrimp vessels; 30 minutes (10 minutes for each of three markings) for vessels with fish traps.

Estimated Total Annual Burden Hours: 6,133.

Estimated Total Annual Cost to Public: $245,290.

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.

The regulations at 50 CFR part 600.503 require that foreign fishing vessels that deploy gear that is not physically and continuously attached to the vessel must mark that gear with a buoy displaying the vessel identification number of the vessel and attach a light visible for two miles on a night with good visibility. The marking of gear aids law enforcement and enables other fishermen to report on gear placed in unauthorized areas.

There currently are no foreign vessels authorized to do fishing that would be subject to this requirement.

No information is collected.

OMB Number: 0648-0354.

Form Number: None.

Type of Review: Regular submission.

Affected Public: Business or other for-profit organizations.

Estimated Number of Respondents: 1.

Estimated Time Per Response: 15 minutes per marking.

Estimated Total Annual Burden Hours: 1.

Estimated Total Annual Cost to Public: $0.

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.

The success of fisheries management programs depends significantly on regulatory compliance. The requirements that fishing gear be marked are essential to facilitate enforcement. The ability to link fishing gear to the vessel owner or operator is crucial to the enforcement of regulations issued under the authority of the Magnuson-Stevens Fishery Conservation and Management Act. The marking of fishing gear is also valuable in actions concerning damage, loss, and civil proceedings. The regulations specify fishing gear must be marked with the vessel's official number, federal permit or tag number, or some other specified form of identification. The regulations further specify how the gear is to be marked (e.g., location and color). Law enforcement personnel rely on this information to assure compliance with fisheries management regulations. Gear that is not properly identified is confiscated. The identifying number on fishing gear is used by NMFS, the U.S. Coast Guard, and other marine agencies in issuing violations, prosecutions, and other enforcement actions. Gear marking helps ensure that a vessel harvests fish only from its own traps/pots/other gear and that traps/pots/other gear are not illegally placed. Gear violations are more readily prosecuted when the gear is marked, allowing for more cost effective enforcement. Cooperating fishermen also use the number to report placement or occurrence of gear in unauthorized areas. Regulation-compliant fishermen ultimately benefit as unauthorized and illegal fishing is deterred and more burdensome regulations are avoided.

The physical marking of fishing buoys is done by the affected public (fishermen in the Pacific Coast Groundfish Fishery) according to regulation. No information is collected.

OMB Number: 0648-0352.

Form Number: None.

Type of Review: Regular submission.

Affected Public: Business or other for-profit organizations.

Estimated Number of Respondents: 548.

Estimated Time Per Response: 15 minutes per marking (with an average of 12 markings per vessel).

Estimated Total Annual Burden Hours: 1,782.

Estimated Total Annual Cost to Public: $23,166.

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.

The success of fisheries management programs depends significantly on regulatory compliance. The vessel identification requirement is essential to facilitate enforcement. The ability to link fishing or other activity to the vessel owner or operator is crucial to enforcement of regulations issued under the authority of the Magnuson-Stevens Fishery Conservation and Management Act. A vessel's official number is required to be displayed on the port and starboard sides of the deckhouse or hull, and on a weather deck. It identifies each vessel and should be visible at distances at sea and in the air. Vessels that qualify for particular fisheries are readily identified, gear violations are more readily prosecuted, and this allows for more cost-effective enforcement. Cooperating fishermen also use the number to report suspicious activities that they observe. Regulation-compliant fishermen ultimately benefit as unauthorized and illegal fishing is deterred and more burdensome regulations are avoided.

Fishing vessel owners physically mark vessel with identification numbers in three locations per vessel. No information is collected.

OMB Number: 0648-0355.

Form Number: None.

Type of Review: Regular submission.

Affected Public: Business or other for-profit organizations (fishermen in the Open Access and Limited Entry Pacific Coast Groundfish Fishery).

Estimated Number of Respondents: 1,693.

Estimated Time Per Response: 45 minutes (15 minutes per marking.

Estimated Total Annual Burden Hours: 1,270 hours.

Estimated Total Annual Cost to Public: $59,255 ($35 per vessel).

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.

Executive Order 13158 directs the Department of Commerce and the Department of the Interior to work with partners to strengthen the protection of U.S. ocean and coastal resources by developing a national system of marine protected areas. The Departments of Commerce and the Interior plan to work closely with state, territorial, local, and tribal governments, as well as other stakeholders, to identify and inventory the Nation's existing marine protected areas. Toward this end, the National Oceanic and Atmospheric Administration (NOAA) and the Department of the Interior (DOI) have created a dataform, available on a password protected website, to be used as a survey tool to collect and analyze information on these existing sites. This survey will allow NOAA and DOI to better understand the existing protections for marine resources within marine protected areas in the United States. This information would also support activities on marine protected areas by state and local governments, tribes, and other interested parties. The survey contains directed questions regarding the location, management and enforcement authorities, types of protections and restrictions, and the length of time those protections or restrictions are in place for each marine protected area. Basic information about the resources and activities at the sites will also be collected. It is expected that site managers from each marine protected area will fill out the survey. The collected information will be housed in a searchable database that will be made available to the public via the marine protected area website at mpa.gov. The survey has been in use for the last three years and this notice proposes to extend the data collection time period.

The information will be collected using a dataform, available on a password protected website. This allows users to enter data at their own pace. The survey contains extensive embedded help and glossary files, as well as required Paperwork Reduction Act information.

OMB Number: 0648-0449.

Form Number: None.

Type of Review: Regular submission.

Affected Public: State, local, or tribal government.

Estimated Number of Respondents: 1,000.

Estimated Time Per Response: 5 hours.

Estimated Total Annual Burden Hours: 5,000.

Estimated Total Annual Cost to Public: $0.

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.

U.S. vessels participating in Antarctic fisheries must mark their fishing gear with the vessel's official identification number, Federal permit or tag number, or another approved form of identification. The information on the gear is used for enforcement of fishery regulations.

Identification information is displayed on fishing gear. No information is collected.

OMB Number: 0648-0367.

Form Number: None.

Type of Review: Regular submission.

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

Estimated Number of Respondents: 3.

Estimated Time Per Response: 5 minutes to mark buoys or floats; 2 minutes to mark traps, pots, or trawl gear.

Estimated Total Annual Burden Hours: 30.

Estimated Total Annual Cost to Public: $900.

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.

The regulations at 50 CFR 622.6(b) and 640.6 require that each fish or spiny lobster trap or pot be marked with a tag or the vessel permit number, depending on the fishery, and have a buoy attached that meets specified identification requirements. The marking of gear aids law enforcement, helps to ensure that vessels only harvest fish from their own gear, and makes it easier for fishermen to report the use of gear in unauthorized locations.

The regulations at 50 CFR 622.41 require that aquaculture site materials be distinguishable from the natural occurring substrate, depending on the area either through marking or other method. The marking of aquacultured site materials aids determination of the origin of those materials and, thereby, helps ensure compliance with the regulations.

Public disclosure via marking the fishing gear. No information is collected.

OMB Number: 0648-0359.

Form Number: None.

Type of Review: Regular submission.

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

Estimated Number of Respondents: 1,000.

Estimated Time Per Response: 20 minutes for marking of a Spanish mackerel gillnet float; 7 minutes to tag a trap; and 10 seconds to mark or tag an aquacultured live rock.

Estimated Total Annual Burden Hours: 2,192.

Estimated Total Annual Cost to Public: $15,200.

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.

The regulations at 50 CFR part 600.503 require that foreign fishing vessels display the vessel's international radio call sign on the port and starboard sides of the deckhouse or hull, and on a weatherdeck. The numbers must be of a specific size. The display of the identifying number aids in fishery law enforcement and allows other fishermen to report suspicious activity.

No information is collected.

OMB Number: 0648-0356.

Form Number: None.

Type of Review: Regular submission.

Affected Public: Business or other for-profit organizations.

Estimated Number of Respondents: 5.

Estimated Time Per Response: 45 minutes (15 minutes for each of three markings).

Estimated Total Annual Burden Hours: 3.75.

Estimated Total Annual Cost to Public: $0.

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.

The National Marine Fisheries Service (NMFS) proposes to collect economic, sociocultural and demographic data through a one-time census about commercial fishing for wreckfish ( Polyprion Americanus ) along the U.S. south Atlantic coast. The wreckfish fishery has been managed with Individual Transferable Quotas (ITQs) since 1992. Few shareholders currently fish for wreckfish, yet they have not sold or leased their shares. This project will address why shareholders chose not to participate in the wreckfish fishery, where and for what species they did fish, and why they did not sell or lease their unused quota to generate revenue even though they did not fish for wreckfish. Equally important is to determine if the process of developing an ITQ system contributed to the rapid increase in fishing effort in the early 1990s. The results of this inquiry could offer important lessons for economists, fishery managers and others researching the appropriateness of applying ITQ systems in other fisheries in the southeast.

Data will be collected through personal interviews with approximately 50 past and current shareholders in the ITQ management system for the wreckfish fishery. Interviews will include coded and open-ended questions to inquire about experiences with the fishery and the ITQ management program. All interviews will be tape-recorded and transcribed. Participation in the study will be voluntary.

OMB Number: None.

Form Number: None.

Type of Review: Regular submission.

Affected Public: Business and other for-profit organizations.

Estimated Number of Respondents: 50.

Estimated Time Per Response: 2 hours.

Estimated Total Annual Burden Hours: 100 hours.

Estimated Total Annual Cost to Public: $0.

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.

Telephone interviews continue to be necessary to determine the intent and capacity of the various sectors of the domestic fleet to harvest and process Pacific whiting. Each year the Pacific whiting optimum yield is divided between the treaty Indian tribes on the coast of Washington State and the three sectors of the non-tribal commercial fisheries (motherships, catcher/processors, and shore-base processor). If it is determined that a sector will be unable to use all of their allocation before the end of the fishing year, NMFS may reapportion whiting to the other sectors to ensure full utilization of the resource. Therefore, it is necessary to collect information, via telephone and/or email, from the groundfish industry to determine the level of interest in harvesting the unused portion of the Pacific whiting resource and to project the number of participants. This survey continues to be valuable and important in groundfish management.

Telephone and email.

OMB Number: 0648-0243.

Form Number: None.

Type of Review: Regular Submission.

Affected Public: Business or other for-profit organizations (owners or operators of vessels that catch or process fish in ocean waters 0-200 nautical miles offshore Washington, Oregon, and California).

Estimated Number of Respondents: 40.

Estimated Time Per Response: 5 minutes.

Estimated Total Annual Burden Hours: 3.33 hours.

Estimated Total Annual Cost to Public: $0 (no capital expenditures required).

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.

The purpose of this data collection is to provide information on the value of Hawaii's coral reef habitats to specific segments of the U.S. population. The study will measure total economic values for Hawaii's coral reefs. This effort is designed to provide defensible information for both resource managers and damage assessments on the value of coral reef habitats and alternative management actions. The project is designed as a phased three-year effort to ensure effective use of all the available information. It will involve the development of extensive knowledge about how reef habitats are perceived, implication of alternative management actions, designing original survey instruments, interviewing of a large number of respondents via an electronically downloadable and submittable pretest (200) and survey (2000), conducting formal statistical analysis of the data, and developing a decision support system for resource managers to use. For total economic value, a nationally oriented survey will be conducted using stated preferences methods.

Data collection will be done in two phases. First, a large-scale pretest of the full survey instrument will be tested for a response of up to 200 usable observations. The pretest data will then be analyzed and the questionnaire revised, as needed. In the second phase, the final survey instrument will be administered to a sample of up to 2000 people. Both the pretest and final surveys are planned as taking an average of 30 minutes per completed interview.

OMB Number: None.

Form Number: None.

Type of Review: Regular submission.

Affected Public: Individuals or households.

Estimated Number of Respondents: 2,200.

Estimated Time Per Response: 30 minutes for a pretest, and 30 minutes for a final survey.

Estimated Total Annual Burden Hours: 1,100.

Estimated Total Annual Cost to Public: $0.

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.

Pursuant to the provisions of the Federal Advisory Committee Act (5 U.S.C. App. 2), these matters constitute classified information that is specifically authorized by Executive Order to be kept secret in the interest of national defense and are, in fact, properly classified pursuant to such Executive Order.

Accordingly, the Secretary of the Navy has determined in writing that the public interest requires that all sessions of the meeting be closed to the public because they will be concerned with matters listed in section 552b(c)(1) of title 5, United States Code.

We invite you to submit comments regarding these selection criteria and other application requirements. Also, we invite you to assist us in complying with the specific requirements of Executive Order 12866 and its overall requirement of reducing regulatory burden that might result from these criteria and other application requirements. Please let us know of any further opportunities we should take to reduce potential costs or increase potential benefits while preserving the effective and efficient administration of the program.

During and after the comment period, you may inspect all public comments about these proposed selection criteria and other application requirements in room 4W218, 400 Maryland Avenue, SW., Washington, DC, between the hours of 8:30 a.m. and 4 p.m., eastern time, Monday through Friday of each week except Federal holidays.

On request, we will supply an appropriate aid, such as a reader or print magnifier, to an individual with a disability who needs assistance to review the comments or other documents in the public rulemaking record for these proposed selection criteria and other application requirements. If you want to schedule an appointment for this type of aid, please contact the person listed under FOR FURTHER INFORMATION CONTACT .

We will announce the final selection criteria and other application requirements in a notice in the Federal Register . We will determine the final selection criteria and other application requirements after considering responses to this notice and other information available to the Department. This notice does not preclude us from proposing additional requirements, subject to meeting applicable rulemaking requirements.

In the past, the selection criteria for the TAH program were taken directly from the program statute and the Education Department General Administrative Regulations (EDGAR). Our experience with competitions, peer reviewers, applicants, and funded grantees demonstrates the need to develop selection criteria that more adequately reflect the qualities of successful TAH grantees. These proposed selection criteria would, therefore, provide the applicant with more detail and clarity with regard to the information that is most likely to result in a high-quality application. Through the selection criteria, we are encouraging applicants to describe: (1) The specific history content to be taught under the grant; (2) how the professional development provided by the grant will improve the quality of instruction; (3) how the evaluation will be aligned with the project design; and (4) the importance of the outcomes likely to be attained through the grant. We also encourage applicants to explain their rationale for selecting certain partners so that the reviewers will have a greater understanding of the potential role and contribution of the partner(s) in achieving the objectives of the grant.

We also encourage applicants to ensure that grant activities will focus on building capacity in the LEA receiving the award. Teachers in the LEA receiving the grant should be the primary recipients of the grant services, and the LEA should be actively involved in the administration of the grant.

We are proposing the additional criteria so that, along with providing a description of the goals and objectives of the application, applicants will describe clear and specific means by which they will achieve those goals and objectives.

The Secretary proposes to use the following selection criteria to evaluate applications under this program. The maximum score for all of these criteria is 100 points. In any given year we will announce the maximum possible score for each criterion, either in the application notice published in the Federal Register or in the application package.

(1) Project quality. The Secretary considers the quality of the proposed project by considering—

(a) The likelihood that the proposed project will develop, implement, and strengthen programs to teach traditional American history as a separate academic subject (not as a component of social studies) within elementary school and secondary school curricula, including the implementation of activities:

(i) To provide professional development and teacher education activities with respect to traditional American history; and

(ii) To improve the quality of instruction in traditional American history.

(b) How specific traditional American history content will be covered by the grant (including the significant issues, episodes, and turning points in the history of the United States; how the words and deeds of individual Americans have determined the course of our Nation; and how the principles of freedom and democracy articulated in the founding documents of this nation have shaped America's struggles and achievements and its social, political, and legal institutions and relations); the format in which the project will deliver the history content; and the quality of the staff and consultants responsible for delivering these content-based professional development activities. The applicant may also attach curriculum vitae for individuals who will provide the content training to the teachers.

(c) How teachers will use the knowledge acquired from project activities to improve the quality of instruction. This description may include plans for reviewing how teachers' lesson planning and classroom teaching are affected by their participation in project activities.

(d) How well the applicant describes a plan that meets the statutory requirement to carry out activities under the grant in partnership with one or more of the following:

(i) An institution of higher education.

(ii) A nonprofit history or humanities organization.

(iii) A library or museum.

(e) The applicant's rationale for selecting the partners and its description of specific activities that the partner(s) will contribute to the grant during each year of the project. The applicant should include a memorandum of understanding or detailed letters of commitment from the partner(s) in an appendix to the application narrative.

(2) Significance. The Secretary considers the significance of the proposed project. In determining the significance of the project, the Secretary considers—

(a) The extent to which the proposed project is likely to build the local capacity, and locally implement services, to improve or expand the LEA's ability to provide American history teachers professional development in traditional American history subject content and content-related teaching strategies.

(b) The importance or magnitude of the results or outcomes likely to be attained by the proposed project, especially improvements in teaching and student achievement.

(3) Quality of the management plan. The Secretary considers the quality of the management plan for the proposed project. In determining the quality of the management plan for the proposed project, the Secretary considers the following factors:

(a) The adequacy of the management plan to achieve the objectives of the proposed project on time and within budget, including clearly defined responsibilities, timelines, and milestones for accomplishing project tasks.

(b) The extent to which the time commitments of the project director and other key project personnel are appropriate and adequate to meet the objectives of the proposed project.

(4) Quality of the project evaluation. The Secretary considers the quality of the evaluation to be conducted of the proposed project. In determining the quality of the evaluation, the Secretary considers:

(a) The extent to which the methods of evaluation include the use of objective performance measures that are clearly related to the intended outcomes of the project and will produce quantitative and qualitative data to the extent possible.

(b) How well the evaluation plans are aligned with the project design explained under the Project Quality criterion.

(c) Whether the evaluation includes benchmarks to monitor progress toward specific project objectives, and outcome measures to assess the impact on teaching and learning or other important outcomes for project participants.

(d) Whether the applicant identifies the individual and/or organization that has agreed to serve as evaluator for the project and includes a description of the qualifications of that evaluator.

(e) The extent to which the applicant indicates the following:

(i) What types of data will be collected;

(ii) When various types of data will be collected;

(iii) What methods will be used to collect data;

(iv) What data collection instruments will be developed;

(v) How the data will be analyzed;

(vi) When reports of results and outcomes will be available;

(vii) How the applicant will use the information collected through the evaluation to monitor the progress of the funded project and to provide accountability information about both success at the initial site and effective strategies for replication in other settings; and

(viii) How the applicant will devote an appropriate level of resources to project evaluation.

The TAH program currently awards $350,000-$1,000,000 total funding for a project period for LEAs with enrollments of fewer than 300,000 students; and $500,000-$2,000,000 for LEAs with enrollments above 300,000. The proposed requirements would permit a maximum of $500,000 for LEAs with enrollments of fewer than 20,000 students; $350,000-$1,000,000 for LEAs with enrollments of 20,000-300,000 students; and $500,000-$2,000,000 for LEAs with enrollments above 300,000 students. As revised, the award amounts would be more proportionate to the number of teachers likely to be served and the number of students enrolled by the LEA.

Currently there is no limit on the number of grants that may be awarded per LEA. The proposed requirements would permit only one award per LEA per competition. This will enable more LEAs to participate in this program.

(1) Total funding for a three-year project period is a maximum or $500,000 for LEAs with enrollments of fewer than 20,000 students; $350,000-$1,000,000 for LEAs with enrollments of 20,000-300,000 students; and $500,000-$2,000,000 for LEAs with enrollments above 300,000 students.

(2) A maximum of one grant will be awarded per LEA per competition.

This notice of proposed selection criteria and other application requirements has been reviewed in accordance with Executive Order 12866. Under the terms of the order, we have assessed the potential costs and benefits of this regulatory action.

The potential costs associated with the notice of proposed selection criteria and other application requirements are those resulting from statutory requirements and those we have determined as necessary for administering this program effectively and efficiently.

In assessing the potential costs and benefits—both quantitative and qualitative—of this notice of proposed selection criteria and other application requirements, we have determined that the benefits of the proposed selection criteria and other application requirements justify the costs.

We have also determined that this regulatory action does not unduly interfere with State, local, and tribal governments in the exercise of their governmental functions.

Summary of potential costs and benefits: The potential cost associated with these proposed selection criteria and other application requirements is minimal while the benefits are significant. Grantees may anticipate costs with completing the application process in terms of staff and partner time, copying, and mailing or delivery. The use of E-Application technology reduces mailing and copying costs significantly.

The benefit of the proposed selection criteria is that they will help applicants prepare higher-quality and more comprehensive proposals.

This program is subject to Executive Order 12372 and the regulations in 34 CFR part 79. One of the objectives of the Executive order is to foster an intergovernmental partnership and a strengthened federalism. The Executive order relies on processes developed by State and local governments for coordination and review of proposed Federal financial assistance.

This document provides early notification of our specific plans and actions for this program.

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: http://www.ed.gov/news/fedregister.

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

The EPA created the Task Force in June 2004 in response to a recommendation from the Permitting/Toxics Subcommittee of the CAAAC. The Task Force is made up of 18 representatives from State and local permitting agencies, industry, and environmental and public interest groups. The Task Force will gather information from interested persons on the performance of the title V operating permits program and prepare a report documenting how the title V program is performing and what elements are working well and/or poorly. The report may include suggestions on how to improve the program. The Task Force is gathering information by, among other things, holding a series of three public meetings. The San Francisco meeting is expected to be the last public meeting. Other public meetings were held in Washington, DC, on June 25, 2004, and Chicago, Illinois, on September 14 and 15, 2004.

The purpose of these public meetings is to gather information on the performance of the title V program, specifically on aspects of the program that are working well and those that are working poorly. The Task Force welcomes any information from stakeholders that will help it prepare its report on the performance of the title V program.

For further information on the task force, see the May 17, 2004, notice in the Federal Register (69 FR 27922) and the CAAAC Web site: http://www.epa.gov/oar/caaac/titlev.html.

Those interested in speaking are asked to contact Ray Vogel by January 24, 2005, by email at vogel.ray@epa.gov and give your email and phone number so you may be contacted for a speaking time. Speaking time slots will be 20 minutes each.

The Task Force requests that presenters at the public meeting limit their presentations to no more than 10 minutes and be prepared to answer follow-up questions from members of the Task Force for approximately 10 minutes. If you wish to present more information than can be accommodated in the allotted time, you should put the information in written remarks that supplement your presentation. Speakers are encouraged to bring disks or hard copies of written remarks to submit for the public record at the meeting. The meeting will be recorded, and a transcript will be made and placed in the public docket. An audio recording will also be made and placed on the Web site http://www.epa.gov/oar/caaac/titlev.html.

As noted above, the Task Force is most interested in testimony based on your experience, of what is working well, what is not working well, and any recommendations you have for improvements to the title V program. We strongly encourage speakers to support their testimony with actual examples designed to help the task force understand your concern(s) and how any recommended improvements you offer would address these concerns.

Audio and written transcripts of the testimony from previous public meetings are available at the CAAAC Web site: http://www.epa.gov/oar/caaac. The draft report (which is expected to be available in winter 2005) will also be available on the Web site. These same materials and additional supporting materials will also be available electronically through the EPA e-docket at: http://www.epa.gov/edocket/. To submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically, select “search,” then key in the appropriate docket ID number. The docket number for this action is OAR-2004-0075.

Interested persons may provide written comments for the task force to consider in lieu of or in addition to making a presentation at the public meeting. The docket for the Title V Performance Task Force is open for submittal of comments until March 31, 2005

The EPA's electronic public docket system is an “anonymous access” system, which means EPA will not know your identity, e-mail address, or other contact information unless you provide it in the body of your comment. Please note: EPA's policy is to not edit your comment; therefore, any identifying or contact information provided in the body of a comment will be included in the official public docket. To submit a comment through EDOCKET, go to http://www.epa.gov/edocket. Once in the system, select “search,” then key in OAR-2004-0075 (the docket ID number for the title V performance task force).

Comments may also be sent by e-mail to: A-and-R-docket@epa.gov, attention Docket ID No. OAR-2004-0075. In contrast to EPA's electronic public docket, EPA's e-mail system is not an “anonymous access” system. The EPA's e-mail system automatically captures your e-mail address and includes it as part of the comment that is placed in the official public docket.

If you submit a disk or CD-ROM, EPA recommends that you include your name, mailing address, e-mail address, or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD-ROM you submit, and in any cover letter accompanying the disk or CD-ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment. If you submit mail, please enclose two copies. Send to: U.S. Environmental Protection Agency, Air and Radiation Docket and Information Center, Mail Code 6102T, 1200 Pennsylvania Avenue, NW., Washington, DC 20460, Attention Docket ID No. OAR-2004-0075.

Deliver comments to: Public Reading Room, Room B102, EPA West Building, 1301 Constitution Avenue, NW., Washington, DC 20004, Attention Docket ID No. OAR-2004-0075.

Deliveries are accepted only between 8:30 a.m. and 4:30 p.m. Eastern Standard Time, Monday through Friday, excluding Federal holidays.

Fax your comments to the EPA Docket Center at (202) 566-1741, Attention Docket ID. No. OAR-2004-0075.

This proposed Agreement concerns the R&R Foundry Superfund Site, located in Topeka, Kansas, and is made and entered into by the EPA and CSE Technologies, Inc. (“the Settling Party”). This Site occupied 0.553 acres, with nearly 0.138 acres of contaminated soil.

In response to the release of hazardous substances including lead at or from the Site, EPA undertook response actions at the Site pursuant to Section 104 of CERCLA, 42 U.S.C. 9604. Approximately 367 tons of lead-contaminated soil were excavated, treated on-site, and disposed off-site. In performing these response actions, EPA incurred response costs at or in connection with the Site.

Pursuant to Section 107(a) of CERCLA, 42 U.S.C. 9607(a), the Settling Party is responsible for response costs incurred at or in connection with the Site. The Regional Administrator of EPA, Region VII, or his designee, has determined that the total past and projected response costs of the United States at or in connection with the Site will not exceed $500,000, excluding interest.

This Agreement requires the Settling Party to pay to the EPA Hazardous Substance Superfund the principal sum of $80,000 in reimbursement of Past Response Costs, and will resolve the Settling Party's alleged civil liability for these costs. The proposed Agreement also includes a covenant not to sue the Settling Party pursuant to Section 107(a) of CERCLA, 42 U.S.C. 9607(a).

Pursuant to Section 2101 of the Public Service Act (42 U.S.C. Section 300aa-1), the Secretary of Health and Human Services was mandated to establish the National Vaccine Program to achieve optimal prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines. The National Vaccine Advisory Committee was established to provide advice and make recommendations to the Assistant Secretary for Health on matters related to the program's responsibilities.

A tentative agenda will be made available on or about January 10 for review on the NVPO Web site: http://www.hhs.gov/nvpo.

Public attendance at the meeting is limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the designated contact person. Members of the public will have the opportunity to provide comments at the meeting. Preregistration is requested for both public attendance and comment. Any individual who wishes to attend the meeting should contact Ms. English.

This conference call is scheduled to begin at 12:30 p.m. eastern standard time. To participate in the teleconference, please dial (877) 315-6535 and enter conference code 383520.

Section 353(f)(4)(A) of the Public Health Service Act (42 U.S.C. 263a) mandates that the Secretary establish national standards for quality assurance in cytology services designed to assure consistent, valid, and reliable test performance by cytology laboratories. Section 353(f)(4)(B)(iv) requires, “* * * the periodic confirmation and evaluation of the proficiency of individuals involved in screening or interpreting cytological preparations, including announced and unannounced on-site proficiency testing of such individuals, with such testing to take place, to the extent practicable, under normal working conditions, * * *” due to the unique nature of this statutory requirement, authority to initiate this system of records is granted. In addition, the general and specific CLIA regulations for laboratories mandating proficiency testing of cytotechnologists and physicians are found in 42 CFR 493.801-493.807 and 493.855. General and specific CLIA requirements for CMS approval of proficiency testing programs in gynecologic cytology are found at 42 CFR 493.901-493.905 and 493.945.

Because of highly publicized articles originating in the Wall Street Journal, and in Washington, DC television exposes, national attention focused on clinical laboratory testing, with specific interest on the testing that occurred in cytology laboratories. Congressional hearings followed.

Many laboratories performing testing on cytology specimens were not regulated and had no limit on the number of gynecologic specimens (Pap smears) that could be examined by an individual in a 24-hour period. Consequently, a number of “Pap Mills” appeared that produced Pap smear results that were erroneous and life threatening.

The failure of laboratories performing cytology testing to provide accurate and reliable patient test results particularly in the area of gynecologic cytology prompted the Congress to enact the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

Certain cytology provisions of the CLIA statute require the Secretary of Health and Human Services to periodically confirm and evaluate the proficiency of individuals involved in screening or interpreting cytological preparations (42 U.S.C. 263a, Section 353(f)(4)(b)(iv)). The Secretary has delegated to the CMS the responsibility to regulate and monitor the accuracy and reliability of results of cytology preparations. The implementing regulations are found at 42 CFR part 493 and apply to all clinical laboratories, performing non-waived testing, including those individuals who examine gynecologic cytology (Pap smears).

To comply with these statutory provisions, a mechanism to monitor the proficiency of individuals who examine gynecologic cytology preparations, a record system must be established. This system, CYPERS, is a national tracking system designed to monitor the enrollment and performance of all cytotechnologists and physicians who must participate in a CMS approved cytology proficiency testing program.

In general, CMS approves proficiency testing (PT) programs offered by private, nonprofit organizations and states that meet the PT program requirements of the CLIA regulations. Laboratories performing certain non-waived testing must enroll and participate in a CMS approved PT program. PT samples are sent to laboratories by the PT programs; the results are unknown to the laboratory staff. After testing, laboratories return their PT sample results to the PT program where they are evaluated and graded for accuracy. The PT program sends the final scores and evaluations to CMS and CMS approved accreditation organizations where monitoring of laboratory performance occurs on a continual basis. In the case of gynecologic cytology PT, the performance of individuals, not laboratories, is monitored using the CYPERS record system.

The CYPERS contains each individual's name, Proficiency Testing Registration Number (a unique identifier), Medical Licensure Number, if employed at more than one laboratory: the names, location, and CLIA number of each laboratory; test scores; and in which testing event the individual has participated. CYPERS will also be able to produce user-defined reports on request by Central Office staff only.

The Privacy Act permits us to disclose information without an individual's consent if the information is to be used for a purpose that is compatible with the purpose(s) for which the information was collected. Any such disclosure of data is known as a “routine use.” The government will only release CYPERS information that can be associated with an individual as provided for under “Section III. Entities Who May Receive Disclosures Under Routine Use.” Both identifiable and non-identifiable data may be disclosed under a routine use. Identifiable data includes individual records with CYPERS information and identifiers. Non-identifiable data includes individual records with CYPERS information and masked identifiers or CYPERS information with identifiers stripped out of the file.

CMS will only disclose the minimum personal data necessary to achieve the purpose of the CYPERS. CMS has the following policies and procedures concerning disclosures of information that will be maintained in the system. In general, disclosure of information from the SOR will be approved only for the minimum information necessary to accomplish the purpose of the disclosure after CMS:

1. Determines that the use or disclosure is consistent with the reason that the data are being collected; e.g., monitoring the registration, participation, and outcome of annual cytology proficiency testing events for cytotechnologist and physicians who evaluate gynecologic cytology specimens, assure remedial actions are taken when necessary, and develop the data necessary for CMS to determine the continued or reduced frequency of testing.

2. Determines that:

a. The purpose for which the disclosure is to be made can only be accomplished if the record is provided in individually identifiable form;

b. the purpose for which the disclosure is to be made is of sufficient importance to warrant the effect and/or risk on the privacy of the individual that additional exposure of the record might bring; and

c. there is a strong probability that the proposed use of the data would, in fact, accomplish the stated purpose(s).

3. Requires the information recipient to:

a. Establish administrative, technical, and physical safeguards to prevent unauthorized use of disclosure of the record;

b. remove or destroy at the earliest time all individually, identifiable information; and

c. agree to not use or disclose the information for any purpose other than the stated purpose under which the information was disclosed.

4. Determines that the data are valid and reliable.

These routine uses specify circumstances, in addition to those provided by statute in the Privacy Act of 1974, under which CMS may release information from the CYPERS without the consent of the individual to whom such information pertains. Each proposed disclosure of information under these routine uses will be evaluated to ensure that the disclosure is legally permissible, including but not limited to ensuring that the purpose of the disclosure is compatible with the purpose for which the information was collected. CMS proposes to establish the following routine use disclosures of information maintained in the system:

1. To agency contractors, or consultants that have been contracted by the agency to assist in the performance of a service related to this system of records and that need to have access to the records in order to perform the activity.

CMS contemplates disclosing information under this routine use only in situations in which CMS may enter into a contractual or similar agreement with a third party to assist in accomplishing agency business functions relating to purposes for this system of records.

CMS occasionally contracts out certain of its functions when doing so would contribute to effective and efficient operations. CMS must be able to give a contractor whatever information is necessary for the contractor to fulfill its duties. In these situations, safeguards are provided in the contract prohibiting the contractor from using or disclosing the information for any purpose other than that described in the contract and requires the contractor to return or destroy all information at the completion of the contract.

2. To a Member of Congress or to a Congressional staff member in response to an inquiry of the Congressional Office made at the written request of the constituent about whom the record is maintained.

Individuals sometimes request the help of a Member of Congress in resolving some issue relating to a matter before CMS. The Member of Congress then writes CMS, and CMS must be able to give sufficient information to be responsive to the inquiry.

3. To the Department of Justice (DOJ), court or adjudicatory body when:

a. The agency or any component thereof, or

b. Any employee of the agency in his or her official capacity; or

c. Any employee of the agency in his or her individual capacity where the DOJ has agreed to represent the employee, or

d. The United States Government; is a party to litigation or has an interest in such litigation, and by careful review, CMS determines that the records are both relevant and necessary to the litigation.

Whenever CMS is involved in litigation, or occasionally when another party is involved in litigation and CMS's policies or operations could be affected by the outcome of the litigation, CMS would be able to disclose information to the DOJ, court or adjudicatory body involved. A determination would be made in each instance that, under the circumstances involved, the purposes served by the use of the information in the particular litigation is compatible with a purpose for which CMS collects the information.

In addition, CMS policy will be to prohibit release even of non-identifiable data, except pursuant to one of the routine uses, if there is a possibility that an individual can be identified through implicit deduction based on small cell sizes (instances where the patient population is so small that individuals who are familiar with the enrollees could, because of the small size, use this information to deduce the identity of the beneficiary).

This System of Records contains Protected Health Information as defined by the Department of Health and Human Services' regulation “Standards for Privacy of Individually Identifiable Health Information” (45 CFR Parts 160 and 164, 65 FR 82462 as amended by 66 FR 12434). Disclosures of Protected Health Information authorized by these routine uses may only be made if, and as, permitted or required by the “Standards for Privacy of Individually Identifiable Health Information.”

CMS has safeguards in place for authorized users and monitors such users to ensure against excessive or unauthorized use. Personnel having access to the system have been trained in the Privacy Act and information security requirements. Employees who maintain records in this system are instructed not to release data until the intended recipient agrees to implement appropriate management, operational and technical safeguards sufficient to protect the confidentiality, integrity and availability of the information and information systems and to prevent unauthorized access.

This system will conform to all applicable Federal laws and regulations and Federal, DHHS, and CMS policies and standards as they relate to information security and data privacy. These laws and regulations include but are not limited to: the Privacy Act of 1974; the Federal Information Security Management Act of 2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance Portability and Accountability Act of 1996; the E-Government Act of 2002, the Clinger-Cohen Act of 1996; the Medicare Modernization Act of 2003, and the corresponding implementing regulations. OMB Circular A-130, Management Of Federal Resources, Appendix III, Security of Federal Automated Information Resources also applies. Federal, DHHS, and CMS policies and standards include but are not limited to: all pertinent NIST publications; the DHHS Automated Information Systems Security Handbook and the CMS Information Security Handbook.

CMS proposes to establish this system in accordance with the principles and requirements of the Privacy Act and will collect, use, and disseminate information only as prescribed therein. Data in this system will be subject to the authorized releases in accordance with the routine uses identified in this system of records.

CMS will monitor the collection and reporting of CYPERS data. CYPERS information is submitted to CMS through standard systems. CMS will use a variety of onsite and offsite edits and audits to increase the accuracy of CYPERS data.

CMS will take precautionary measures (see item IV, above) to minimize the risks of unauthorized access to the records and the potential harm to individual privacy or other personal or property rights of individuals whose data are maintained in the system. CMS will collect only that information necessary to perform the system's functions. In addition, CMS will make disclosure from the proposed system only with consent of the subject individual, or his/her legal representative, or in accordance with an applicable exception provision of the Privacy Act.

CMS, therefore, does not anticipate an unfavorable effect on individual privacy because of maintaining this system of records.

In accordance with 24 CFR part 581 and section 501 of the Stewart B. McKinney Homeless Assistance Act (42 U.S.C. 11411), as amended, HUD is publishing this Notice to identify Federal buildings and other real property that HUD has reviewed for suitability for use to assist the homeless. The properties were reviewed using information provided to HUD by Federal landholding agencies regarding unutilized and underutilized buildings and real property controlled by such agencies or by GSA regarding its inventory of excess or surplus Federal property. This Notice is also published in order to comply with the December 12, 1988 Court Order in National Coalition for the Homeless v. Veterans Administration, No. 88-2503-OG (D.D.C.).

Properties reviewed are listed in this Notice according to the following categories: Suitable/available, suitable/unavailable, suitable/to be excess, and unsuitable. The properties listed in the three suitable categories have been reviewed by the landholding agencies, and each agency has transmitted to HUD: (1) Its intention to make the property available for use to assist the homeless, (2) its intention to declare the property excess to the agency's needs, or (3) a statement of the reasons that the property cannot be declared excess or made available for use as facilities to assist the homeless.

Properties listed as suitable/available will be available exclusively for homeless use for a period of 60 days from the date of this Notice. Where property is described as for “off-site use only” recipients of the property will be required to relocate the building to their own site at their own expense. Homeless assistance providers interested in any such property should send a written expression of interest to HHS, addressed to Heather Ranson, Division of Property Management, Program Support Center, HHS, room 5B-17, 5600 Fishers Lane, Rockville, MD 20857; (301) 443-2265. (This is not a toll-free number.) HHS will mail to the interested provider an application packet, which will include instructions for completing the application. In order to maximize the opportunity to utilize a suitable property, providers should submit their written expressions of interest as soon as possible. For complete details concerning the processing of applications, the reader is encouraged to refer to the interim rule governing this program, 24 CFR part 581.

For properties listed as suitable/to be excess, that property may, if subsequently accepted as excess by GSA, be made available for use by the homeless in accordance with applicable law, subject to screening for other Federal use. At the appropriate time, HUD will publish the property in a Notice showing it as either suitable/available or suitable/unavailable.

For properties listed as suitable/unavailable, the landholding agency has decided that the property cannot be declared excess or made available for use to assist the homeless, and the property will not be available.

Properties listed as unsuitable will not be made available for any other purpose for 20 days from the date of this Notice. Homeless assistance providers interested in a review by HUD of the determination of unsuitability should call the toll free information line at 1-800-927-7588 for detailed instructions or write a letter to Mark Johnston at the address listed at the beginning of this Notice. Included in the request for review should be the property address (including zip code), the date of publication in the Federal Register , the landholding agency, and the property number.

For more information regarding particular properties identified in this Notice ( i.e. , acreage, floor plan, existing sanitary facilities, exact street address), providers should contact the appropriate landholding agencies at the following addresses: AGRICULTURE: Ms. Marsha Pruitt, Realty Officer, Department of Agriculture, Reporters Building, 300 7th St., SW., Rm 310B, Washington, DC 20250; (202) 720-4335; COE: Ms. Shirley Middleswarth, Army Corps of Engineers, Civil Division, Directorate of Real Estate, 441 G Street, NW., Washington, DC 20314-1000; (202) 761-7425; COAST GUARD: Commandant (G-SEC), United States Coast Guard, Attn: Teresa Sheinberg, 2100 Second St., SW., Rm 6109, Washington, DC 20593-0001; (202) 267-6142; ENERGY: Mr. Andy Duran, Department of Energy, Office of Engineering & Construction Management, ME-90, 1000 Independence Ave., SW., Washington, DC 20585: (202) 586-4548; GSA: Mr. Brian K. Polly, Assistant Commissioner, General Services Administration, Office of Property Disposal, 18th and F Streets, NW., Washington, DC 20405; (202) 501-0084; INTERIOR: Ms. Linda Tribby, Acquisition & Property Management, Department of the Interior, 1849 C Street, NW., MS5512, Washington, DC 20240; (202) 219-0728; NAVY: Mr. Charles C. Cocks, Department of the Navy, Real Estate Policy Division, Naval Facilities Engineering Command, Washington Navy Yard, 1322 Patterson Ave., SE., Suite 1000, Washington, DC 20374-5065; (202) 685-9200; VA: Ms. Amelia E. McLellan, Director, Real Property Service, Department of Veterans Affairs, 810 Vermont Avenue, NW., Rm 419, Washington, DC 20420; (202) 565-5398; (These are not toll-free numbers).

Copies of the Final EIS will be available for viewing and downloading online at:

1. http://migratorybirds.pacific.fws.gov/CATE.htm,

2. http://www.nwp.usace.army.mil/pm/e/, and

3. http://nwr.noaa.gov.

Printed documents will also be available for review at the following libraries:

1. North Olympic Library System, Port Angeles Branch, Port Angeles, WA,

2. North Olympic Library System, Sequim Branch, Sequim, WA,

3. Astoria Public Library, Astoria, OR,

4. Multnomah County Central Library, Portland, OR,

5. Eugene Public Library, Eugene, OR,

6. Lake County Library, Lakeview, OR,

7. San Francisco Public Library, San Francisco, CA, and

8. Oakland Main Public Library, Oakland, CA

Copies of the Final EIS may be obtained by writing to U.S. Fish and Wildlife Service, Migratory Birds and Habitat Programs, Attn: Nanette Seto, 911 NE. 11th Avenue, Portland, OR, 97232, or cateeis@fws.gov.

Recent increases in the number of Caspian terns nesting in the Columbia River estuary, Oregon, have led to concerns over their potential impact on the recovery of threatened and endangered Columbia River salmon. In 2000, Seattle Audubon, National Audubon, American Bird Conservancy, and Defenders of Wildlife filed a lawsuit against the Corps alleging that compliance with NEPA for a proposed action of relocating the large colony of Caspian terns from Rice Island to East Sand Island was insufficient, and against the Service in objection to the potential take of eggs as a means to prevent nesting on Rice Island. In 2002, all parties reached a settlement agreement. The settlement agreement stipulates that the Service, Corps, and NOAA Fisheries prepare an EIS to address Caspian tern management in the Columbia River estuary and juvenile salmonid predation.

The three cooperating agencies analyzed four alternatives for future Caspian tern management in the Columbia River estuary; of these, Alternative C has been identified as the preferred alternative.

Alternative C has not been modified from the Draft EIS which was released on July 23, 2004 for public review. This alternative proposes management actions that would reduce tern predation on juvenile salmonids in the Columbia River estuary by redistributing a portion of the tern colony on East Sand Island throughout the Pacific Coast/Western region. This would be achieved by reducing the tern nesting site on East Sand Island to approximately 1 to 1.5 acres and managing sites in Washington, Oregon, and California specifically for displaced Caspian terns. Future management sites include Dungeness National Wildlife Refuge, Washington; Summer, Crump, and Fern Ridge lakes, Oregon; and Brooks Island, Hayward Regional Shoreline, and Don Edwards San Francisco Bay National Wildlife Refuge in San Francisco Bay, California. We expect a colony size of approximately 2,500 to 3,125 nesting pairs to remain on East Sand Island.

The Corps would continue efforts, such as hazing ( e.g. , disturbance to terns prior to the nesting season), to prevent Caspian tern nesting on upper estuary islands ( e.g. , Rice Island, Miller Sands Spit, Pillar Rock Island) of the Columbia River estuary to prevent high tern predation rates of juvenile salmonids and comply with the 1999 Corps Columbia River Channel Operation and Maintenance Program Biological Opinion. The Service would issue an egg take permit to the Corps for upper estuary islands (not including East Sand Island) if the efforts to prevent tern nesting at these sites fail. Additionally, the Corps would resume dredged material ( e.g. , sand) disposal on the downstream end of Rice Island, on the former Caspian tern nesting site.

Public comments were requested, considered, and incorporated throughout the planning process in numerous ways. Public outreach has included open houses, planning updates, Federal Register notices, and a project website. Two previous notices were published in the Federal Register concerning this EIS (68 FR 16826, April 7, 2003 and 69 FR 44053, July 23, 2004). During the Draft EIS comment period (July 23, 2004 to September 21, 2004), the Service received a total of 37 comments (e-mails, letters, faxes, or postcards). All substantive issues raised in the comments have been addressed through revisions incorporated into the Final EIS text or in responses to comments contained in Appendix J of the Final EIS.

Under Section 11 of the Indian Gaming Regulatory Act of 1988 (IGRA), Public Law 100-497, 25 U.S.C. 2710, the Secretary of the Interior shall publish in the Federal Register notice of approved Tribal-State Compacts for the purpose of engaging in Class III gaming activities on Indian lands.

On January 6, 1998, the Assistant Secretary-Indian Affairs, Department of the Interior, through his delegated authority, approved the Compact between the Pyramid Lake Paiute Tribe and the State of Nevada, which was executed on August 4, 1997. The Compact is extended until January 5, 2006.

This planning activity encompasses approximately 400,000 acres of public land in the Deschutes Resource Area, Prineville District, and is located primarily in Deschutes, Crook, and Jefferson Counties in central Oregon. The BLM has worked and will continue to work closely with all interested parties to identify management decisions that are best suited to the needs of the public. Final decisions will revise the portion of the Brothers La-Pine Resource Management Plan (1989) included in the Upper Deschutes planning area boundary, and will modify the boundary of the Two Rivers RMP. Some management direction will be clarified for the Middle Deschutes and Lower Crooked River Wild and Scenic River Plans. The Upper Deschutes Resource Management Plan will also incorporate strategies and direction provided by the National and Central Oregon Fire Management Plan.

This land use plan focuses on the principles of multiple use management and sustained yield as prescribed by Section 202 of the FLPMA. The PRMP/FEIS considers and analyzes seven alternatives. These alternatives were developed based on a unique collaborative process. The Deschutes Provincial Advisory Committee chartered a working group including tribal, federal, state and local governments, private citizens, and interest groups. The working group reached consensus on the range of alternatives, reviewed public comments on the Draft EIS, and reached consensus on changes to the Draft Preferred Alternative.

The alternatives detailed in the PRMP/FEIS provide for a wide array of land use allocations and management direction as well as variable levels of resource protection, commodity production, and authorized land and resource uses. Alternative 7, the BLM preferred alternative (as modified by public comment on the Draft RMP/EIS,) is the basis for the goals, objectives, and guidelines included in the Proposed RMP. The PRMP provides a balance of land and resource uses across the planning area and provides the framework for making present and future decisions for authorizing activities, such as grazing and mineral uses, considering the significant population growth anticipated in the area over the next 10-20 years.

The plan will also allocate lands within the planning area for the long-term training use of the Oregon Military Department and National Guard. The lands identified for military use within the Upper Deschutes RMP are proposed for non-competitive lease under Section 302(b) of FLPMA. The legal description of the lands proposed for lease are identified within the PRMP/FEIS.

Copies of the Upper Deschutes PRMP/FEIS have been sent to affected Federal, State, and local government agencies and to interested parties. The PRMP/FEIS is available for public inspection at the Prineville District Office in Prineville, Oregon, during regular business hours (7:45 a.m. to 4:30 p.m., Monday through Friday, except holidays). Copies are also available at the Deschutes, Jefferson, and Crook County Libraries. Interested persons may also review the PRMP/FEIS on the Internet at: http://www.or.blm.gov/Prineville/Deschutes_RMP/Home.htm. Comments on the Draft RMP/EIS received from the public and internal BLM review comments were incorporated into the proposed plan where appropriate. Comments resulted in clarifications, technical corrections, changes to the alternatives, and changes to the analysis.

Instructions for filing a protest with the Director of the BLM regarding the PRMP/FEIS may be found at 43 CFR 1610.5. A protest may only raise those issues that were submitted for the record during the planning process. E-mail and faxed protests will not be accepted as valid protests unless the protesting party also provides the original letter by either regular or overnight mail postmarked by the close of the protest period. Under these conditions, BLM will consider the e-mail or faxed protest as an advance copy and it will receive full consideration. If you wish to provide BLM with such advance notification, please direct faxed protests to the attention of the BLM protest coordinator at 202-452-5112 and e-mails to Brenda_Hudgens-Williams@blm.gov. Please direct the follow-up letter to the appropriate address provided below. To be considered complete, your protest must contain (at a minimum) the following information:

(1) Name, mailing address, telephone number, and the affected interest of the person filing the protest(s).

(2) A statement of the part or parts of the proposed plan being protested. To the extent possible, reference specific pages, paragraphs, and sections of the document.

(3) A copy of all your documents addressing the issue or issues which were discussed with the BLM for the record.

(4) A concise statement explaining why the proposed decision is believed to be incorrect. This is a critical part of your protest. Document all relevant facts, as much as possible. A protest merely expressing disagreement with the State Director's proposed decision without providing any supporting data will not be considered a valid protest.

All protests must be in writing and mailed to the following address:

To be considered timely, your protest must be postmarked no later than the last day of the protest period. Though not a requirement, we suggest you send your protest by certified mail, return receipt requested. You are also encouraged, but not required, to forward a copy of your protest to the Project Manager at the address listed under FOR FURTHER INFORMATION above. This may allow us to resolve the protest through clarification of intent or alternative dispute resolution methods.

Please note that protests, including names and street addresses, are available for public review and/or release under the Freedom of Information Act (FOIA). Individual respondents may request confidentiality. Respondents who wish to withhold their name and/or street address from public review or from disclosure under FOIA must state this prominently at the beginning of the written comment. Such request will be honored to the extent allowed by law. All submissions from organizations or businesses, and from individuals identifying themselves as representatives of official organizations or businesses, will be made available for public inspection in their entirety.

The Director will promptly render a decision on the protest. This decision will be in writing and will be sent to the protesting party by certified mail, return receipt requested. The decision of the Director shall be the final decision of the Department of the Interior.

The planning area includes all of the public land and federal mineral ownership managed by the Vernal Field Office in Daggett, Duchesne, and Uintah Counties, in northeast Utah, and about 3,000 acres in Grand County. The planning area encompasses public lands currently managed under the Book Cliffs and Diamond Mountain Resource Management Plans (RMP). This area includes approximately 1.8 million acres of BLM administered surface lands and 2.1 million acres of federal mineral lands under federal, state, private, and Ute Tribal surface in the three county areas.

The Draft RMP Revision/EIS addresses alternatives, management guidance, monitoring, and impact analysis of the alternatives. The alternatives present differing management balances between the various resources and uses. This planning effort will revise the Book Cliffs (1985) and Diamond Mountain (1994) RMPs. Once approved, the Record of Decision (ROD) for the Vernal Field Office RMP Revision will supercede all existing management plans for the planning area. SWCA Environmental Consultants in Salt Lake City, Utah is assisting the BLM in the planning process and in the preparation of the document. In order to receive full consideration, comments should focus on specific management actions being considered and the adequacy of analysis. Responses to the comments will be published as part of the Final RMP Revision/EIS. The Draft RMP Revision/EIS contains four alternatives (including the No Action Alternative). Major issues considered are: management of oil and gas resources, special designation areas, wildlife, special status plants and animals, regional air quality, and recreation.

This survey was executed at the request of the U.S. Forest Service and was necessary to delineate Forest Service lands. The lands we surveyed are:

The plat, in 1 sheet, representing the dependent resurvey of a portion of the Black Hills Base Line, through Range 14 East, a portion of the subdivisional lines, and the adjusted original meanders of the former right bank of the South Fork of the Cheyenne River, through sections 5, 7, and 8, and the subdivision of section 5, and the survey of a certain division of accretion line and the meanders of the present right bank of the South Fork of the Cheyenne River, through portions of sections 5 and 7, and through section 8, Township 1 South, Range 14 East, Black Hills Meridian, South Dakota, was accepted December 9, 2004.

We will place copies of the plat, in 1 sheet, and related field notes we described in the open files. They will be available to the public as a matter of information.

If BLM receives a protest against this survey, as shown on this plat, in 1 sheet, prior to the date of the official filing, we will stay the filing pending our consideration of the protest.

We will not officially file this plat, in 1 sheet, until the day after we have accepted or dismissed all protests and they have become final, including decisions or appeals.

The Commission instituted this investigation on April 14, 2004, based on a complaint filed on behalf of Zoran Corporation and Oak Technology, Inc. both of Sunnyvale, CA (collectively “complainants).” 69 FR 19876. The complaint, as supplemented, alleged violations of section 337 of the Tariff Act of 1930 in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain optical disk controller chips and chipsets and products containing same, including DVD players and PC optical storage devices, by reason of infringement of claims 1-12 of U.S. Patent No. 6,466,736 (the ‘736 patent), claims 1-3 of U.S. Patent No. 6,584,527, and claims 1-35 of U.S. Patent No. 6,546,440 (the ‘440 patent). The notice of investigation identified 12 respondents. On June 7, 2004, the ALJ issued an ID (Order No. 5) terminating the investigation as to two respondents on the basis of a consent order and settlement agreement. On June 22, 2004, the ALJ issued an ID (Order No. 7) granting complainants' motion to amend the complaint and notice of investigation to add nine additional respondents. Those IDs were not reviewed by the Commission.

On December 22, 2004, complainants moved pursuant to Commission rule 210.21(a) to terminate the investigation in part by withdrawal of the infringement allegations as to claims 2-6, 8-10, and 11 of the ‘736 patent and claims 2-4, 6, 9, 11, 12, 15-18, 20, 22-34, and 35 of the ‘440 patent. No responses to the motion were filed.

On December 22, 2004, the presiding administrative law judge issued an ID (Order No. 33) granting the motion.

No petitions for review of the ID were filed.

The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in section 210.42 of the Commission's Rules of Practice and Procedure (19 CFR 210.42).

On November 15, 2004, in accordance with section 2104(a)(1) of the Trade Act of 2002, the United States Trade Representative (USTR) notified the Congress of the President's intent to enter into free trade negotiations with Oman. The notification letters to the Senate and the House of Representatives can be found on the USTR Web site at http://www.ustr.gov/assets/Document_Library/Letters_to_Congress/2004/asset_upload_file22_6743.pdf and http://www.ustr.gov/assets/Document_Library/Letters_to_Congress/2004/asset_upload_file752_6742.pdf, respectively. In December, USTR announced its intention to hold a public hearing on January 14, 2005, for the interagency Trade Policy Staff Committee (TPSC) to receive written comments and oral testimony from the public to assist USTR in formulating positions and proposals with respect to all aspects of the negotiations (69 FR 70498) (Dec. 6, 2004). USTR intends to launch the negotiations in March 2005.

The Trade Act of 2002 (Pub. L. 107-210) (the Trade Act) sets forth special procedures (Trade Promotion Authority) for approval and implementation of Agreements subject to meeting conditions and requirements in Division B of the Trade Act, “Bipartisan Trade Promotion Authority.” Section 2102(a)-(c) of the Trade Act includes negotiating objectives and a listing of priorities for the President to promote in order to “address and maintain United States competitiveness in the global economy” in pursuing future trade agreements. The President assigned several of the functions in section 2102(c) to the Secretary of Labor. (E.O. 13277). These include the functions set forth in section 2102(c)(8), which requires that the President “in connection with any trade negotiations entered into under this Act, submit to the Committee on Ways and Means of the House of Representatives and the Committee on Finance of the Senate a meaningful labor rights report of the country, or countries, with respect to which the President is negotiating,” and the function in section 2102(c)(9), which requires that the President “with respect to any trade agreement which the President seeks to implement under trade authorities procedures, submit to the Congress a report describing the extent to which the country or countries that are parties to the agreement have in effect laws governing exploitative child labor.”

Interested parties are invited to submit written information as specified below to be taken into account in drafting the required reports. Materials submitted should be confined to the specific topics of the reports. In particular, agencies are seeking written submissions on the following topics:

1. Labor laws of Oman, including laws governing exploitative child labor, and that country's implementation and enforcement of its labor laws and regulations;

2. The situation in Oman with respect to core labor standards;

3. Steps taken by Oman to comply with International Labor Organization Convention No. 182 on the worst forms of child labor; and

4. The nature and extent, if any, of exploitative child labor in Oman.

Section 2113(6) of the Trade Act defines “core labor standards” as:

(A) The right of association;

(B) The right to organize and bargain collectively;

(C) A prohibition on the use of any form of forced or compulsory labor;

(D) A minimum age for the employment of children; and

(E) Acceptable conditions of work with respect to minimum wages, hours of work, and occupational safety and health.

This document is a request for facts or opinions submitted in response to a general solicitation of comments from the public. To ensure prompt and full consideration of submissions, we strongly recommend that interested persons submit comments by electronic mail to the following e-mail address: FRFTAOman@dol.gov. Persons making submissions by e-mail should use the following subject line: “Oman: Labor Rights and Child Labor Reports.” Documents should be submitted in WordPerfect, MSWord, or text (.TXT) format. Supporting documentation submitted as spreadsheets is acceptable in Quattro Pro or Excel format. Persons who make submissions by e-mail should not provide separate cover letters; information that might appear in a cover letter should be included in the submission itself. Similarly, to the extent possible, any attachments to the submission should be included in the same file as the submission itself, and not as separate files. Written comments will be placed in a file open to public inspection at the Department of Labor, Room S-5317, 200 Constitution Avenue, NW., Washington, DC 20210, and in the USTR Reading Room in Room 3 of the annex of the Office of the USTR, 1724 F Street, NW., Washington, DC 20508. An appointment to review the file at the Department of Labor may be made by contacting Betsy White at (202) 693-4919. An appointment to review the file at USTR may be made by calling (202) 395-6186. The USTR Reading Room is generally open to the public from 10 a.m.-12 noon and 1-4 p.m., Monday through Friday. Appointments must be scheduled at least 48 hours in advance.

On November 15, 2004, in accordance with section 2104(a)(1) of the Trade Act of 2002, the United States Trade Representative (USTR) notified the Congress of the President's intent to enter into free trade negotiations with the United Arab Emirates (UAE). The notification letters to the Senate and the House of Representatives can be found on the USTR Web site at http://www.ustr.gov/assets/Document_Library/Letters_to_Congress/2004/asset_upload_file848_6741.pdf and http://www.ustr.gov/assets/Document_Library/Letters_to_Congress/2004/asset_upload_file847_6740.pdf, respectively. In December, USTR announced its intention to hold a public hearing on January 12, 2005, for the interagency Trade Policy Staff Committee (TPSC) to receive written comments and oral testimony from the public to assist USTR in formulating positions and proposals with respect to all aspects of the negotiations (69 FR 70500) (Dec. 6, 2004). USTR intends to launch the negotiations in March 2005.

The Trade Act of 2002 (Pub.L. 107-210) (the Trade Act) sets forth special procedures (Trade Promotion Authority) for approval and implementation of Agreements subject to meeting conditions and requirements in Division B of the Trade Act, “Bipartisan Trade Promotion Authority.” Section 2102(a)-(c) of the Trade Act includes negotiating objectives and a listing of priorities for the President to promote in order to “address and maintain United States competitiveness in the global economy” in pursuing future trade agreements. The President assigned several of the functions in section 2102(c) to the Secretary of Labor. (E.O. 13277). These include the functions set forth in section 2102(c)(8), which requires that the President “in connection with any trade negotiations entered into under this Act, submit to the Committee on Ways and Means of the House of Representatives and the Committee on Finance of the Senate a meaningful labor rights report of the country, or countries, with respect to which the President is negotiating,” and the function in section 2102(c)(9), which requires that the President “with respect to any trade agreement which the President seeks to implement under trade authorities procedures, submit to the Congress a report describing the extent to which the country or countries that are parties to the agreement have in effect laws governing exploitative child labor.”

Interested parties are invited to submit written information as specified below to be taken into account in drafting the required reports. Materials submitted should be confined to the specific topics of the reports. In particular, agencies are seeking written submissions on the following topics:

1. Labor laws of the UAE, including laws governing exploitative child labor, and that country's implementation and enforcement of its labor laws and regulations;

2. The situation in the UAE with respect to core labor standards;

3. Steps taken by the UAE to comply with International Labor Organization Convention No. 182 on the worst forms of child labor; and

4. The nature and extent, if any, of exploitative child labor in the UAE.

Section 2113(6) of the Trade Act defines “core labor standards” as:

(A) The right of association;

(B) The right to organize and bargain collectively;

(C) A prohibition on the use of any form of forced or compulsory labor;

(D) A minimum age for the employment of children; and

(E) Acceptable conditions of work with respect to minimum wages, hours of work, and occupational safety and health.

This document is a request for facts or opinions submitted in response to a general solicitation of comments from the public. To ensure prompt and full consideration of submissions, we strongly recommend that interested persons submit comments by electronic mail to the following e-mail address: FRFTAUAE@dol.gov. Persons making submissions by e-mail should use the following subject line: “UAE: Labor Rights and Child Labor Reports.” Documents should be submitted in WordPerfect, MSWord, or text (.TXT) format. Supporting documentation submitted as spreadsheets is acceptable in Quattro Pro or Excel format. Persons who make submissions by e-mail should not provide separate cover letters; information that might appear in a cover letter should be included in the submission itself. Similarly, to the extent possible, any attachments to the submission should be included in the same file as the submission itself, and not as separate files. Written comments will be placed in a file open to public inspection at the Department of Labor, Room S-5317, 200 Constitution Avenue, NW., Washington, DC 20210, and in the USTR Reading Room in Room 3 of the annex of the Office of the USTR, 1724 F Street, NW., Washington, DC 20508. An appointment to review the file at the Department of Labor may be made by contacting Betsy White at (202) 693-4919. An appointment to review the file at USTR may be made by calling (202) 395-6186. The USTR Reading Room is generally open to the public from 10 a.m.-12 noon and 1-4 p.m., Monday through Friday. Appointments must be scheduled at least 48 hours in advance.

The Quarterly Census of Employment and Wages (QCEW) program, a Federal/State cooperative effort, produces monthly employment and quarterly wage information. It is a by-product of quarterly reports submitted to State Workforce Agencies (SWAs) by employers subject to State Unemployment Insurance (UI) laws. The collection of these data is authorized by 29 U.S.C. 1, 2. The QCEW data, which are compiled for each calendar quarter, provide a comprehensive business name and address file with employment and wage information for employers subject to State UI laws. Similar data for Federal Government employers covered by the Unemployment Compensation for Federal Employees program also are included. These data are submitted to the BLS by all 50 States, the District of Columbia, Puerto Rico, and the Virgin Islands. The BLS summarizes these data to produce totals for all counties, Metropolitan Statistical Areas, the States, and the nation. The QCEW program provides a virtual census of nonagricultural employees and their wages, with about 55 percent of the workers in agriculture covered as well.

The QCEW program is a comprehensive and accurate source of data on the number of establishments, monthly employment, and quarterly wages, by industry, at the six-digit North American Industry Classification System (NAICS) level, and at the national, State, Metropolitan Statistical Area, and county levels. The QCEW series has broad economic significance in measuring labor trends and major industry developments, in time series analyses of establishments, employment, and wages by size of establishment.

The Bureau of Labor Statistics is particularly interested in comments that:

• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

• Enhance the quality, utility, and clarity of the information to be collected; and

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

Office of Management and Budget clearance is being sought for the Quarterly Census of Employment and Wages (QCEW) program.

The QCEW program is the only Federal statistical program that provides information on establishments, wages, tax contributions and the number of employees subject to State UI laws and the Unemployment Compensation for Federal Employees program. The consequences of not collecting QCEW data would be grave to the Federal statistical community. The BLS would not have a sampling frame for its establishment surveys; it would not be able to publish as accurate current estimates of employment for the U.S., States, and metropolitan areas; and it would not be able to publish quarterly census totals of local establishment counts, employment and wages. The Bureau of Economic Analysis would not be able to publish as accurate personal income data in a timely manner for the U.S., States, and local areas. Finally, the Employment Training Administration would not have the information it needs to administer the Unemployment Insurance Program.

Type of Review: Revision of a currently approved collection.

Agency: Bureau of Labor Statistics.

Title: Quarterly Census of Employment and Wages (QCEW) Program.

OMB Number: 1220-0012.

Affected Public: State Government.

Total Respondents: 53.

Frequency: Quarterly.

Total Responses: 212.

Average Time Per Response: 5,180 hours.

Estimated Total Burden Hours: 1,098,240 hours.

Total Burden Cost (capital/startup): $0.

Total Burden Cost (operating/maintenance): $0.

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

The meeting will be open to the public up to the capacity of the room. Attendees will be requested to sign a register.

The agenda for the meeting includes the following topics:

It is imperative that the meeting be held on this date to accommodate the scheduling priorities of the key participants.

On December 7, 2003, the National Science Foundation published a notice in the Federal Register of a Waste Management permit application received. A Waste Management permit was issued on January 7, 2005 to the following applicant: Steve Brooks, Pole to Pole; Permit No.: 2005 WM-005.

On June 16, 2004, the NRC published in the Federal Register a final rule amending 10 CFR 50.48 (69 FR 33536). This rule became effective on July 16, 2004, and allows licensees to adopt 10 CFR 50.48(c), a voluntary risk-informed, performance-based alternative to current fire protection requirements. The NRC concurrently revised its Enforcement Policy (69 FR 33684) to provide interim enforcement discretion during a “transition” period. The interim enforcement discretion policy includes provisions to address (1) noncompliances identified during the licensee's transition process and, (2) existing identified noncompliances.

In accordance with the current Enforcement Policy, for noncompliances identified as part of the transition to 10 CFR 50.48(c), the enforcement discretion period begins upon the receipt of a letter of intent from the licensee stating its intention to adopt 10 CFR 50.48(c) and it would remain in effect for up to two years. Furthermore, when the licensee submits a license amendment request to complete the transition to 10 CFR 50.48(c), the enforcement discretion will continue until the NRC completes its review of the license amendment request.

The second element of the interim enforcement discretion policy provides enforcement discretion for licensees who wish to take advantage of the new rule to resolve existing noncompliances. One of the criteria that must be met to exercise this discretion is that the licensee must submit a letter of intent to adopt 10 CFR 50.48(c) within 6 months of the effective date of the final rule. Therefore, the current deadline for the letter of intent to allow discretion for existing noncompliances is January 16, 2005.

As a result, if a licensee submits a letter of intent on or before January 16, 2005, (in order to meet the second discretion element) the enforcement discretion for noncompliances identified during the licensee's transition process (the first discretion element) would remain in effect until January 15, 2007.

By letter dated July 7, 2004, the Nuclear Energy Institute (NEI) (ADAMS Accession ML042010132) requested that NRC extend the deadline for the letter of intent from January 16, 2005, to December 31, 2005. According to the NEI letter, the primary basis for this request is to accommodate the licensee planning and budgeting for transition to 10 CFR 50.48(c).

The NRC considered NEI's request in light of possible safety implications, the NRC's regulatory philosophy to provide incentives for licensees to move to risk-informed, performance-based fire protection requirements, and the NRC's need to put long standing fire protection issues on a closure path.

When the NRC issued the interim enforcement discretion policy, the NRC chose to limit the time allowed to submit a letter of intent to 6 months for existing noncompliances because the NRC wanted to prevent undue delays in either restoring compliance to 10 CFR 50.48(b) or establishing compliance to 10 CFR 50.48(c). The NRC did not consider the challenges imposed on the licensees in budgeting and planning. After receiving NEI's request to extend the time allowed for the letter of intent by one year, the NRC reevaluated potential safety concerns associated with a one year extension to existing noncompliances. The NRC concludes that granting NEI's request does not adversely affect public health and safety because:

• Enforcement discretion does not apply to the risk-significant issues, which under the Reactor Oversight Process would be evaluated as Red;

• Enforcement discretion does not apply to issues that would be categorized as Severity Level I;

• The licensee is required to adopt compensatory measures until compliance is either restored to 10 CFR 50.48(b) or achieved per 10 CFR 50.48(c), and

• Licensees potentially would be identifying and addressing improvements to existing programs.

In addition to allowing licensees time for budgeting and planning to adopt 10 CFR 50.48(c), this extension will also allow licensees to consider the draft Regulatory Guide (RG) and the probabilistic risk assessment (PRA) and fire modeling tools in their decision. This RG and the PRA were issued for public comment in October 2004. The fire modeling tools will be issued for public comment in Summer 2005.

This policy statement does not contain new or amended information collection requirements subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) Existing requirements were approved by the Office of Management and Budget (OMB), approval number 3150-0136. The approved information collection requirements contained in this policy statement appear in Section VII.C.

The NRC may not conduct or sponsor, and a person is not required to respond to, collection of information unless it displays a currently valid OMB control number.

In accordance with the Small Business Regulatory Enforcement Fairness Act of 1996, the NRC had determined that this action is not a major rule and has verified this determination with the Office of Information and Regulatory Affairs of OMB.

Accordingly, the proposed revision to the NRC Enforcement Policy reads as follows:

This Bulletin establishes that important scientific information shall be peer reviewed by qualified specialists before it is disseminated by the Federal government. We published a proposed Bulletin on September 15, 2003. Based on public comments, we published a revised proposal for additional comment on April 28, 2004. We are now finalizing the April version, with minor revisions responsive to the public's comments.

The purpose of the Bulletin is to enhance the quality and credibility of the government's scientific information. We recognize that different types of peer review are appropriate for different types of information. Under this Bulletin, agencies are granted broad discretion to weigh the benefits and costs of using a particular peer review mechanism for a specific information product. The selection of an appropriate peer review mechanism for scientific information is left to the agency's discretion. Various types of information are exempted from the requirements of this Bulletin, including time-sensitive health and safety determinations, in order to ensure that peer review does not unduly delay the release of urgent findings.

This Bulletin also applies stricter minimum requirements for the peer review of highly influential scientific assessments, which are a subset of influential scientific information. A scientific assessment is an evaluation of a body of scientific or technical knowledge that typically synthesizes multiple factual inputs, data, models, assumptions, and/or applies best professional judgment to bridge uncertainties in the available information. To ensure that the Bulletin is not too costly or rigid, these requirements for more intensive peer review apply only to the more important scientific assessments disseminated by the Federal government.

Even for these highly influential scientific assessments, the Bulletin leaves significant discretion to the agency formulating the peer review plan. In general, an agency conducting a peer review of a highly influential scientific assessment must ensure that the peer review process is transparent by making available to the public the written charge to the peer reviewers, the peer reviewers' names, the peer reviewers' report(s), and the agency's response to the peer reviewers' report(s). The agency selecting peer reviewers must ensure that the reviewers possess the necessary expertise. In addition, the agency must address reviewers' potential conflicts of interest (including those stemming from ties to regulated businesses and other stakeholders) and independence from the agency. This Bulletin requires agencies to adopt or adapt the committee selection policies employed by the National Academy of Sciences (NAS)  1 when selecting peer reviewers who are not government employees. Those that are government employees are subject to federal ethics requirements. The use of a transparent process, coupled with the selection of qualified and independent peer reviewers, should improve the quality of government science while promoting public confidence in the integrity of the government's scientific products.

Peer review is one of the important procedures used to ensure that the quality of published information meets the standards of the scientific and technical community. It is a form of deliberation involving an exchange of judgments about the appropriateness of methods and the strength of the author's inferences. 2 Peer review involves the review of a draft product for quality by specialists in the field who were not involved in producing the draft.

The peer reviewer's report is an evaluation or critique that is used by the authors of the draft to improve the product. Peer review typically evaluates the clarity of hypotheses, the validity of the research design, the quality of data collection procedures, the robustness of the methods employed, the appropriateness of the methods for the hypotheses being tested, the extent to which the conclusions follow from the analysis, and the strengths and limitations of the overall product.

Peer review has diverse purposes. Editors of scientific journals use reviewer comments to help determine whether a draft scientific article is of sufficient quality, importance, and interest to a field of study to justify publication. Research funding organizations often use peer review to evaluate research proposals. In addition, some Federal agencies make use of peer review to obtain evaluations of draft information that contains important scientific determinations.

Peer review should not be confused with public comment and other stakeholder processes. The selection of participants in a peer review is based on expertise, with due consideration of independence and conflict of interest. Furthermore, notice-and-comment procedures for agency rulemaking do not provide an adequate substitute for peer review, as some experts—especially those most knowledgeable in a field—may not file public comments with Federal agencies.

The critique provided by a peer review often suggests ways to clarify assumptions, findings, and conclusions. For instance, peer reviews can filter out biases and identify oversights, omissions, and inconsistencies. 3 Peer review also may encourage authors to more fully acknowledge limitations and uncertainties. In some cases, reviewers might recommend major changes to the draft, such as refinement of hypotheses, reconsideration of research design, modifications of data collection or analysis methods, or alternative conclusions. However, peer review does not always lead to specific modifications in the draft product. In some cases, a draft is in excellent shape prior to being submitted for review. In others, the authors do not concur with changes suggested by one or more reviewers.

Peer review may take a variety of forms, depending upon the nature and importance of the product. For example, the reviewers may represent one scientific discipline or a variety of disciplines; the number of reviewers may range from a few to more than a dozen; the names of each reviewer may be disclosed publicly or may remain anonymous ( e.g. , to encourage candor); the reviewers may be blinded to the authors of the report or the names of the authors may be disclosed to the reviewers; the reviewers may prepare individual reports or a panel of reviewers may be constituted to produce a collaborative report; panels may do their work electronically or they may meet together in person to discuss and prepare their evaluations; and reviewers may be compensated for their work or they may donate their time as a contribution to science or public service.

For large, complex reports, different reviewers may be assigned to different chapters or topics. Such reports may be reviewed in stages, sometimes with confidential reviews that precede a public process of panel review. As part of government-sponsored peer review, there may be opportunity for written and/or oral public comments on the draft product.

The results of peer review are often only one of the criteria used to make decisions about journal publication, grant funding, and information dissemination. For instance, the editors of scientific journals (rather than the peer reviewers) make final decisions about a manuscript's appropriateness for publication based on a variety of considerations. In research-funding decisions, the reports of peer reviewers often play an important role, but the final decisions about funding are often made by accountable officials based on a variety of considerations. Similarly, when a government agency sponsors peer review of its own draft documents, the peer review reports are an important factor in information dissemination decisions but rarely are the sole consideration. Agencies are not expected to cede their discretion with regard to dissemination or use of information to peer reviewers; accountable agency officials must make the final decisions.

There are a multiplicity of science advisory procedures used at Federal agencies and across the wide variety of scientific products prepared by agencies. 4 In response to congressional inquiry, the U.S. General Accounting Office (now the Government Accountability Office) documented the variability in both the definition and implementation of peer review across agencies. 5 The Carnegie Commission on Science, Technology and Government  6 has highlighted the importance of “internal” scientific advice (within the agency) and “external” advice (through scientific advisory boards and other mechanisms).

A wide variety of authorities have argued that peer review practices at federal agencies need to be strengthened. 7 Some arguments focus on specific types of scientific products ( e.g. , assessments of health, safety and environmental hazards). 8 The Congressional/Presidential Commission on Risk Assessment and Risk Management suggests that “peer review of economic and social science information should have as high a priority as peer review of health, ecological, and engineering information.”  9

Some agencies have formal peer review policies, while others do not. Even agencies that have such policies do not always follow them prior to the release of important scientific products.

Prior to the development of this Bulletin, there were no government-wide standards concerning when peer review is required and, if required, what type of peer review processes are appropriate. No formal interagency mechanism existed to foster cross-agency sharing of experiences with peer review practices and policies. Despite the importance of peer review for the credibility of agency scientific products, the public lacked a consistent way to determine when an important scientific information product is being developed by an agency, the type of peer review planned for that product, or whether there would be an opportunity to provide comments and data to the reviewers.

This Bulletin establishes minimum standards for when peer review is required for scientific information and the types of peer review that should be considered by agencies in different circumstances. It also establishes a transparent process for public disclosure of peer review planning, including a Web-accessible description of the peer review plan that the agency has developed for each of its forthcoming influential scientific disseminations.

This Bulletin is issued under the Information Quality Act and OMB's general authorities to oversee the quality of agency information, analyses, and regulatory actions. In the Information Quality Act, Congress directed OMB to issue guidelines to “provide policy and procedural guidance to Federal agencies for ensuring and maximizing the quality, objectivity, utility and integrity of information” disseminated by Federal agencies. Public Law No. 106-554, § 515(a). The Information Quality Act was developed as a supplement to the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. , which requires OMB, among other things, to “develop and oversee the implementation of policies, principles, standards, and guidelines to * * * apply to Federal agency dissemination of public information.” In addition, Executive Order 12866, 58 FR 51,735 (Oct. 4, 1993), establishes that OIRA is “the repository of expertise concerning regulatory issues,” and it directs OMB to provide guidance to the agencies on regulatory planning. E.O. 12866, § 2(b). The Order also requires that “[e]ach agency shall base its decisions on the best reasonably obtainable scientific, technical, economic, or other information.” E.O. 12866, § 1(b)(7). Finally, OMB has authority in certain circumstances to manage the agencies under the purview of the President's Constitutional authority to supervise the unitary Executive Branch. All of these authorities support this Bulletin.

This Bulletin addresses peer review of scientific information disseminations that contain findings or conclusions that represent the official position of one or more agencies of the Federal government.

Section I provides definitions that are central to this Bulletin. Several terms are identical to or based on those used in OMB's government-wide information quality guidelines, 67 FR 8452 (Feb. 22, 2002), and the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

The term “Administrator” means the Administrator of the Office of Information and Regulatory Affairs in the Office of Management and Budget (OIRA).

The term “agency” has the same meaning as in the Paperwork Reduction Act, 44 U.S.C. 3502(1).

The term “Information Quality Act” means Section 515 of Public Law 106-554 (Pub. L. No. 106-554, § 515, 114 Stat. 2763, 2763A-153-154 (2000)).

The term “dissemination” means agency initiated or sponsored distribution of information to the public. Dissemination does not include distribution limited to government employees or agency contractors or grantees; intra-or inter-agency use or sharing of government information; or responses to requests for agency records under the Freedom of Information Act, the Privacy Act, the Federal Advisory Committee Act, the Government Performance and Results Act, or similar laws. This definition also excludes distribution limited to correspondence with individuals or persons, press releases, archival records, public filings, subpoenas and adjudicative processes. In the context of this Bulletin, the definition of “dissemination” modifies the definition in OMB's government-wide information quality guidelines to address the need for peer review prior to official dissemination of the information product. Accordingly, under this Bulletin, “dissemination” also excludes information distributed for peer review in compliance with this Bulletin or shared confidentially with scientific colleagues, provided that the distributing agency includes an appropriate and clear disclaimer on the information, as explained more fully below. Finally, the Bulletin does not directly cover information supplied to the government by third parties ( e.g. , studies by private consultants, companies and private, non-profit organizations, or research institutions such as universities). However, if an agency plans to disseminate information supplied by a third party ( e.g. , using this information as the basis for an agency's factual determination that a particular behavior causes a disease), the requirements of the Bulletin apply, if the dissemination is “influential”.

In cases where a draft report or other information is released by an agency solely for purposes of peer review, a question may arise as to whether the draft report constitutes an official “dissemination” under information-quality guidelines. Section I instructs agencies to make this clear by presenting the following disclaimer in the report:

In cases where the information is highly relevant to specific policy or regulatory deliberations, this disclaimer shall appear on each page of a draft report. Agencies also shall discourage state, local, international and private organizations from using information in draft reports that are undergoing peer review. Draft influential scientific information presented at scientific meetings or shared confidentially with colleagues for scientific input prior to peer review shall include the disclaimer: “The Findings and Conclusions in This Report (Presentation) Have Not Been Formally Disseminated by [The Agency] and Should Not Be Construed to Represent Any Agency Determination or Policy.”

An information product is not covered by the Bulletin unless it represents an official view of one or more departments or agencies of the Federal government. Accordingly, for the purposes of this Bulletin, “dissemination” excludes research produced by government-funded scientists ( e.g. , those supported extramurally or intramurally by Federal agencies or those working in state or local governments with Federal support) if that information is not represented as the views of a department or agency ( i.e. , they are not official government disseminations). For influential scientific information that does not have the imprimatur of the Federal government, scientists employed by the Federal government are required to include in their information product a clear disclaimer that “the findings and conclusions in this report are those of the author(s) and do not necessarily represent the views of the funding agency.” A similar disclaimer is advised for non-government employees who publish government-funded research.

For the purposes of the peer review Bulletin, the term “scientific information” means factual inputs, data, models, analyses, technical information, or scientific assessments related to such disciplines as the behavioral and social sciences, public health and medical sciences, life and earth sciences, engineering, or physical sciences. This includes any communication or representation of knowledge such as facts or data, in any medium or form, including textual, numerical, graphic, cartographic, narrative, or audiovisual forms. This definition includes information that an agency disseminates from a Web page, but does not include the provision of hyperlinks on a Web page to information that others disseminate. This definition excludes opinions, where the agency's presentation makes clear that an individual's opinion, rather than a statement of fact or of the agency's findings and conclusions, is being offered.

The term “influential scientific information” means scientific information the agency reasonably can determine will have or does have a clear and substantial impact on important public policies or private sector decisions. In the term “influential scientific information,” the term “influential” should be interpreted consistently with OMB's government-wide information quality guidelines and the information quality guidelines of the agency. Information dissemination can have a significant economic impact even if it is not part of a rulemaking. For instance, the economic viability of a technology can be influenced by the government's characterization of its attributes. Alternatively, the Federal government's assessment of risk can directly or indirectly influence the response actions of state and local agencies or international bodies.

One type of scientific information is a scientific assessment. For the purposes of this Bulletin, the term “scientific assessment” means an evaluation of a body of scientific or technical knowledge, which typically synthesizes multiple factual inputs, data, models, assumptions, and/or applies best professional judgment to bridge uncertainties in the available information. These assessments include, but are not limited to, state-of-science reports; technology assessments; weight-of-evidence analyses; meta-analyses; health, safety, or ecological risk assessments; toxicological characterizations of substances; integrated assessment models; hazard determinations; or exposure assessments. Such assessments often draw upon knowledge from multiple disciplines. Typically, the data and models used in scientific assessments have already been subject to some form of peer review ( e.g. , refereed journal peer review or peer review under Section II of this Bulletin).

Section II requires each agency to subject “influential” scientific information to peer review prior to dissemination. For dissemination of influential scientific information, Section II provides agencies broad discretion in determining what type of peer review is appropriate and what procedures should be employed to select appropriate reviewers. Agencies are directed to chose a peer review mechanism that is adequate, giving due consideration to the novelty and complexity of the science to be reviewed, the relevance of the information to decision making, the extent of prior peer reviews, and the expected benefits and costs of additional review.

The National Academy of Public Administration suggests that the intensity of peer review should be commensurate with the significance of the information being disseminated and the likely implications for policy decisions. 10 Furthermore, agencies need to consider tradeoffs between depth of peer review and timeliness. 11 More rigorous peer review is necessary for information that is based on novel methods or presents complex challenges for interpretation. Furthermore, the need for rigorous peer review is greater when the information contains precedent-setting methods or models, presents conclusions that are likely to change prevailing practices, or is likely to affect policy decisions that have a significant impact.

This tradeoff can be considered in a benefit-cost framework. The costs of peer review include both the direct costs of the peer review activity and those stemming from potential delay in government and private actions that can result from peer review. The benefits of peer review are equally clear: the insights offered by peer reviewers may lead to policy with more benefits and/or fewer costs. In addition to contributing to strong science, peer review, if performed fairly and rigorously, can build consensus among stakeholders and reduce the temptation for courts and legislators to second-guess or overturn agency actions. 12 While it will not always be easy for agencies to quantify the benefits and costs of peer review, agencies are encouraged to approach peer review from a benefit-cost perspective.

Regardless of the peer review mechanism chosen, agencies should strive to ensure that their peer review practices are characterized by both scientific integrity and process integrity. “Scientific integrity,” in the context of peer review, refers to such issues as “expertise and balance of the panel members; the identification of the scientific issues and clarity of the charge to the panel; the quality, focus and depth of the discussion of the issues by the panel; the rationale and supportability of the panel's findings; and the accuracy and clarity of the panel report.” “Process integrity” includes such issues as “transparency and openness, avoidance of real or perceived conflicts of interest, a workable process for public comment and involvement,” and adherence to defined procedures. 13

When deciding what type of peer review mechanism is appropriate for a specific information product, agencies will need to consider at least the following issues: Individual versus panel review; timing; scope of the review; selection of reviewers; disclosure and attribution; public participation; disposition of reviewer comments; and adequacy of prior peer review.

Letter reviews by several experts generally will be more expeditious than convening a panel of experts. Individual letter reviews are more appropriate when a draft document covers only one discipline or when premature disclosure of a sensitive report to a public panel could cause harm to government or private interests. When time and resources warrant, panels are preferable, as they tend to be more deliberative than individual letter reviews and the reviewers can learn from each other. There are also multi-stage processes in which confidential letter reviews are conducted prior to release of a draft document for public notice and comment, followed by a formal panel review. These more rigorous and expensive processes are particularly valuable for highly complex, multidisciplinary, and more important documents, especially those that are novel or precedent-setting.

As a general rule, it is most useful to consult with peers early in the process of producing information. For example, in the context of risk assessments, it is valuable to have the choice of input data and the specification of the model reviewed by peers before the agency invests time and resources in implementing the model and interpreting the results. “Early” peer review occurs in time to “focus attention on data inadequacies in time for corrections.

When an information product is a critical component of rule-making, it is important to obtain peer review before the agency announces its regulatory options so that any technical corrections can be made before the agency becomes invested in a specific approach or the positions of interest groups have hardened. If review occurs too late, it is unlikely to contribute to the course of a rulemaking. Furthermore, investing in a more rigorous peer review early in the process “may provide net benefit by reducing the prospect of challenges to a regulation that later may trigger time consuming and resource-draining litigation.”  14

The “charge” contains the instructions to the peer reviewers regarding the objective of the peer review and the specific advice sought. The importance of the information, which shapes the goal of the peer review, influences the charge. For instance, the goal of the review might be to determine the utility of a body of literature for drawing certain conclusions about the feasibility of a technology or the safety of a product. In this context, an agency might ask reviewers to determine the relevance of conclusions drawn in one context for other contexts ( e.g. , different exposure conditions or patient populations).

The charge to the reviewers should be determined in advance of the selection of the reviewers. In drafting the charge, it is important to remember the strengths and limitations of peer review. Peer review is most powerful when the charge is specific and steers the reviewers to specific technical questions while also directing reviewers to offer a broad evaluation of the overall product.

Uncertainty is inherent in science, and in many cases individual studies do not produce conclusive evidence. Thus, when an agency generates a scientific assessment, it is presenting its scientific judgment about the accumulated evidence rather than scientific fact. 15 Specialists attempt to reach a consensus by weighing the accumulated evidence. Peer reviewers can make an important contribution by distinguishing scientific facts from professional judgments. Furthermore, where appropriate, reviewers should be asked to provide advice on the reasonableness of judgments made from the scientific evidence. However, the charge should make clear that the reviewers are not to provide advice on the policy ( e.g. , the amount of uncertainty that is acceptable or the amount of precaution that should be embedded in an analysis). Such considerations are the purview of the government. 16

The charge should ask that peer reviewers ensure that scientific uncertainties are clearly identified and characterized. Since not all uncertainties have an equal effect on the conclusions drawn, reviewers should be asked to ensure that the potential implications of the uncertainties for the technical conclusions drawn are clear. In addition, peer reviewers might be asked to consider value-of-information analyses that identify whether more research is likely to decrease key uncertainties. 17 Value-of-information analysis was suggested for this purpose in the report of the Presidential/Congressional Commission on Risk Assessment and Risk Management. 18 A description of additional research that would appreciably influence the conclusions of the assessment can help an agency assess and target subsequent efforts.

Expertise. The most important factor in selecting reviewers is expertise: ensuring that the selected reviewer has the knowledge, experience, and skills necessary to perform the review. Agencies shall ensure that, in cases where the document being reviewed spans a variety of scientific disciplines or areas of technical expertise, reviewers who represent the necessary spectrum of knowledge are chosen. For instance, expertise in applied mathematics and statistics is essential in the review of models, thereby allowing an audit of calculations and claims of significance and robustness based on the numeric data. 19 For some reviews, evaluation of biological plausibility is as important as statistical modeling. Agencies shall consider requesting that the public, including scientific and professional societies, nominate potential reviewers.

Balance. While expertise is the primary consideration, reviewers should also be selected to represent a diversity of scientific perspectives relevant to the subject. On most controversial issues, there exists a range of respected scientific viewpoints regarding interpretation of the available literature. Inviting reviewers with competing views on the science may lead to a sharper, more focused peer review. Indeed, as a final layer of review, some organizations ( e.g. , the National Academy of Sciences) specifically recruit reviewers with strong opinions to test the scientific strength and balance of their reports. The NAS policy on committee composition and balance  20 highlights important considerations associated with perspective, bias, and objectivity.

Independence. In its narrowest sense, independence in a reviewer means that the reviewer was not involved in producing the draft document to be reviewed. However, for peer review of some documents, a broader view of independence is necessary to assure credibility of the process. Reviewers are generally not employed by the agency or office producing the document. As the National Academy of Sciences has stated, “external experts often can be more open, frank, and challenging to the status quo than internal reviewers, who may feel constrained by organizational concerns.”  21 The Carnegie Commission on Science, Technology, and Government notes that “external science advisory boards serve a critically important function in providing regulatory agencies with expert advice on a range of issues.”  22 However, the choice of reviewers requires a case-by-case analysis. Reviewers employed by other Federal and state agencies may possess unique or indispensable expertise.

A related issue is whether government-funded scientists in universities and consulting firms have sufficient independence from the federal agencies that support their work to be appropriate peer reviewers for those agencies. 23 This concern can be mitigated in situations where the scientist initiates the hypothesis to be tested or the method to be developed, which effectively creates a buffer between the scientist and the agency. When an agency awards grants through a competitive process that includes peer review, the agency's potential to influence the scientist's research is limited. As such, when a scientist is awarded a government research grant through an investigator-initiated, peer-reviewed competition, there generally should be no question as to that scientist's ability to offer independent scientific advice to the agency on other projects. This contrasts, for example, to a situation in which a scientist has a consulting or contractual arrangement with the agency or office sponsoring a peer review. Likewise, when the agency and a researcher work together ( e.g. , through a cooperative agreement) to design or implement a study, there is less independence from the agency. Furthermore, if a scientist has repeatedly served as a reviewer for the same agency, some may question whether that scientist is sufficiently independent from the agency to be employed as a peer reviewer on agency-sponsored projects.

As the foregoing suggests, independence poses a complex set of questions that must be considered by agencies when peer reviewers are selected. In general, agencies shall make an effort to rotate peer review responsibilities across the available pool of qualified reviewers, recognizing that in some cases repeated service by the same reviewer is needed because of essential expertise.

Some agencies have built entire organizations to provide independent scientific advice while other agencies tend to employ ad hoc scientific panels on specific issues. Respect for the independence of reviewers may be enhanced if an agency collects names of potential reviewers (based on considerations of expertise and reputation for objectivity) from the public, including scientific or professional societies. The Department of Energy's use of the American Society of Mechanical Engineers to identify potential peer reviewers from a variety of different scientific societies provides an example of how professional societies can assist in the development of an independent peer review panel. 24

Conflict of Interest. The National Academy of Sciences defines “conflict of interest” as any financial or other interest that conflicts with the service of an individual on the review panel because it could impair the individual's objectivity or could create an unfair competitive advantage for a person or organization. 25 This standard provides a useful benchmark for agencies to consider in selecting peer reviewers. Agencies shall make a special effort to examine prospective reviewers' potential financial conflicts, including significant investments, consulting arrangements, employer affiliations and grants/contracts. Financial ties of potential reviewers to regulated entities ( e.g. , businesses), other stakeholders, and regulatory agencies shall be scrutinized when the information being reviewed is likely to be relevant to regulatory policy. The inquiry into potential conflicts goes beyond financial investments and business relationships and includes work as an expert witness, consulting arrangements, honoraria and sources of grants and contracts. To evaluate any real or perceived conflicts of interest with potential reviewers and questions regarding the independence of reviewers, agencies are referred to federal ethics requirements, applicable standards issued by the Office of Government Ethics, and the prevailing practices of the National Academy of Sciences. Specifically, peer reviewers who are Federal employees (including special government employees) are subject to Federal requirements governing conflicts of interest. See, e.g. , 18 U.S.C. 208; 5 CFR part 2635 (2004). With respect to reviewers who are not Federal employees, agencies shall adopt or adapt the NAS policy for committee selection with respect to evaluating conflicts of interest. 26 Both the NAS and the Federal government recognize that under certain circumstances some conflict may be unavoidable in order to obtain the necessary expertise. See, e.g. , 18 U.S.C. 208(b)(3); 5 U.S.C. App. 15 (governing NAS committees). To improve the transparency of the process, when an agency determines that it is necessary to use a reviewer with a real or perceived conflict of interest, the agency should consider publicly disclosing those conflicts. In such situations, the agency shall inform potential reviewers of such disclosure at the time they are recruited.

Peer reviewers must have a clear understanding of how their comments will be conveyed to the authors of the document and to the public. When peer review of government reports is considered, the case for transparency is stronger, particularly when the report addresses an issue with significant ramifications for the public and private sectors. The public may not have confidence in the peer review process when the names and affiliations of the peer reviewers are unknown. Without access to the comments of reviewers, the public is incapable of determining whether the government has seriously considered the comments of reviewers and made appropriate revisions. Disclosure of the slate of reviewers and the substance of their comments can strengthen public confidence in the peer review process. It is common at many journals and research funding agencies to disclose annually the slate of reviewers. Moreover, the National Academy of Sciences now discloses the names of its peer reviewers, without disclosing the substance of their comments. The science advisory committees to regulatory agencies typically disclose at least a summary of the comments of reviewers as well as their names and affiliations.

For agency-sponsored peer review conducted under Sections II and III, this Bulletin strikes a compromise by requiring disclosure of the identity of the reviewers, but not public attribution of specific comments to specific reviewers. The agency has considerable discretion in the implementation of this compromise ( e.g. , summarizing the views of reviewers as a group or disclosing individual reviewer comments without attribution). Whatever approach is employed, the agency must inform reviewers in advance of how it intends to address this issue. Information about a reviewer retrieved from a record filed by the reviewer's name or other identifier may be disclosed only as permitted by the conditions of disclosure enumerated in the Privacy Act, 5 U.S.C. 552a as amended, and as interpreted in OMB implementing guidance, 40 FR 28,948 (July 9, 1975).

Public comments can be important in shaping expert deliberations. Agencies may decide that peer review should precede an opportunity for public comment to ensure that the public receives the most scientifically strong product (rather than one that may change substantially as a result of peer reviewer suggestions). However, there are situations in which public participation in peer review is an important aspect of obtaining a high-quality product through a credible process. Agencies, however, should avoid open-ended comment periods, which may delay completion of peer reviews and complicate the completion of the final work product.

Public participation can take a variety of forms, including opportunities to provide oral comments before a peer review panel or requests to provide written comments to the peer reviewers. Another option is for agencies to publish a “request for comment” or other notice in which they solicit public comment before a panel of peer reviewers performs its work.

A peer review is considered completed once the agency considers and addresses the reviewers' comments. All reviewer comments should be given consideration and be incorporated where relevant and valid. For instance, in the context of risk assessments, the National Academy of Sciences recommends that peer review include a written evaluation made available for public inspection. 27 In cases where there is a public panel, the agency should plan publication of the peer review report(s) and the agency's response to peer reviewer comments.

In addition, the credibility of the final scientific report is likely to be enhanced if the public understands how the agency addressed the specific concerns raised by the peer reviewers. Accordingly, agencies should consider preparing a written response to the peer review report explaining: The agency's agreement or disagreement, the actions the agency has undertaken or will undertake in response to the report, and (if applicable) the reasons the agency believes those actions satisfy any key concerns or recommendations in the report.

In light of the broad range of information covered by Section II, agencies are directed to choose a peer review mechanism that is adequate, giving due consideration to the novelty and complexity of the science to be reviewed, the relevance of the information to decision making, the extent of prior peer reviews, and the expected benefits and costs of additional review.

Publication in a refereed scientific journal may mean that adequate peer review has been performed. However, the intensity of peer review is highly variable across journals. There will be cases in which an agency determines that a more rigorous or transparent review process is necessary. For instance, an agency may determine a particular journal review process did not address questions ( e.g. , the extent of uncertainty inherent in a finding) that the agency determines should be addressed before disseminating that information. As such, prior peer review and publication is not by itself sufficient grounds for determining that no further review is necessary.

Whereas Section II leaves most of the considerations regarding the form of the peer review to the agency's discretion, Section III requires a more rigorous form of peer review for highly influential scientific assessments. The requirements of Section II of this Bulletin apply to Section III, but Section III has some additional requirements, which are discussed below. In planning a peer review under Section III, agencies typically will have to devote greater resources and attention to the issues discussed in Section II, i.e., individual versus panel review; timing; scope of the review; selection of reviewers; disclosure and attribution; public participation; and disposition of reviewer comments.

A scientific assessment is considered “highly influential” if the agency or the OIRA Administrator determines that the dissemination could have a potential impact of more than $500 million in any one year on either the public or private sector or that the dissemination is novel, controversial, or precedent-setting, or has significant interagency interest. One of the ways information can exert economic impact is through the costs or benefits of a regulation based on the disseminated information. The qualitative aspect of this definition may be most useful in cases where it is difficult for an agency to predict the potential economic effect of dissemination. In the context of this Bulletin, it may be either the approach used in the assessment or the interpretation of the information itself that is novel or precedent-setting. Peer review can be valuable in establishing the bounds of the scientific debate when methods or interpretations are a source of controversy among interested parties. If information is covered by Section III, an agency is required to adhere to the peer review procedures specified in Section III.

Section III(2) clarifies that the principal findings, conclusions and recommendations in official reports of the National Academy of Sciences that fall under this Section are generally presumed not to require additional peer review. All other highly influential scientific assessments require a review that meets the requirements of Section III of this Bulletin.

With regard to the selection of reviewers, Section III(3)(a) emphasizes consideration of expertise and balance. As discussed in Section II, expertise refers to the required knowledge, experience and skills required to perform the review whereas balance refers to the need for diversity in scientific perspective and disciplines. We emphasize that the term “balance” here refers not to balancing of stakeholder or political interests but rather to a broad and diverse representation of respected perspectives and intellectual traditions within the scientific community, as discussed in the NAS policy on committee composition and balance. 28

Section III(3)(b) instructs agencies to consider barring participation by scientists with a conflict of interest. The conflict of interest standards for Sections II and III of the Bulletin are identical. As discussed under Section II, those peer reviewers who are Federal employees, including Special Government Employees, are subject to applicable statutory and regulatory standards for Federal employees. For non-government employees, agencies shall adopt or adapt the NAS policy for committee member selection with respect to evaluating conflicts of interest.

Section III(3)(c) instructs agencies to ensure that reviewers are independent of the agency sponsoring the review. Scientists employed by the sponsoring agency are not permitted to serve as reviewers for highly influential scientific assessments. This does not preclude Special Government Employees, such as academics appointed to advisory committees, from serving as peer reviewers. The only exception to this ban would be the rare situation in which a scientist from a different agency of a Cabinet-level department than the agency that is disseminating the scientific assessment has expertise, experience and skills that are essential but cannot be obtained elsewhere. In evaluating the need for this exception, agencies shall use the NAS criteria for assessing the appropriateness of using employees of sponsors ( e.g. , the government scientist must not have had any part in the development or prior review of the scientific information and must not hold a position of managerial or policy responsibility).

We also considered whether a reviewer can be independent of the agency if that reviewer receives a substantial amount of research funding from the agency sponsoring the review. Research grants that were awarded to the scientist based on investigator-initiated, competitive, peer-reviewed proposals do not generally raise issues of independence. However, significant consulting and contractual relationships with the agency may raise issues of independence or conflict, depending upon the situation.

Section III(3)(d) addresses concerns regarding repeated use of the same reviewer in multiple assessments. Such repeated use should be avoided unless a particular reviewer's expertise is essential. Agencies should rotate membership across the available pool of qualified reviewers. Similarly, when using standing panels of scientific advisors, it is suggested that the agency rotate membership among qualified scientists in order to obtain fresh perspectives and reinforce the reality and perception of independence from the agency.

Section III(4) requires agencies to provide reviewers with sufficient background information, including access to key studies, data and models, to perform their role as peer reviewers. In this respect, the peer review envisioned in Section III is more rigorous than some forms of journal peer review, where the reviewer is often not provided access to underlying data or models. Reviewers shall be informed of applicable access, objectivity, reproducibility and other quality standards under Federal information quality laws.

Section III(5) addresses opportunity for public participation in peer review, and provides that the agency shall, wherever possible, provide for public participation. In some cases, an assessment may be so sensitive that it is critical that the agency's assessment achieve a high level of quality before it is publicized. In those situations, a rigorous yet confidential peer review process may be appropriate, prior to public release of the assessment. If an agency decides to make a draft assessment publicly available at the onset of a peer review process, the agency shall, whenever possible, provide a vehicle for the public to provide written comments, make an oral presentation before the peer reviewers, or both. When written public comments are received, the agency shall ensure that peer reviewers receive copies of comments that address significant scientific issues with ample time to consider them in their review. To avoid undue delay of agency activities, the agency shall specify time limits for public participation throughout the peer review process.

Section III(6) requires that agencies instruct reviewers to prepare a peer review report that describes the nature and scope of their review and their findings and conclusions. The report shall disclose the name of each peer reviewer and a brief description of his or her organizational affiliation, credentials and relevant experiences. The peer review report should either summarize the views of the group as a whole (including any dissenting views) or include a verbatim copy of the comments of the individual reviewers (with or without attribution of specific views to specific names). The agency shall also prepare a written response to the peer review report, indicating whether the agency agrees with the reviewers and what actions the agency has taken or plans to take to address the points made by reviewers. The agency is required to disseminate the peer review report and the agency's response to the report on the agency's Web site, including all the materials related to the peer review such as the charge statement, peer review report, and agency response to the review. If the scientific information is used to support a final rule then, where practicable, the peer review report shall be made available to the public with enough time for the public to consider the implications of the peer review report for the rule being considered.

Section III(7) authorizes but does not require an agency to commission an entity independent of the agency to select peer reviewers and/or manage the peer review process in accordance with this Bulletin. The entity may be a scientific or professional society, a firm specializing in peer review, or a non-profit organization with experience in peer review.

Peer review as described in this Bulletin is only one of many procedures that agencies can employ to ensure an appropriate degree of pre-dissemination quality of influential scientific information. For example, Congress has assigned the NAS a special role in advising the Federal government on scientific and technical issues. The procedures of the NAS are generally quite rigorous, and thus agencies should presume that major findings, conclusions, and recommendations of NAS reports meet the performance standards of this Bulletin.

As an alternative to complying with Sections II and III of this Bulletin, an agency may instead (1) rely on scientific information produced by the National Academy of Sciences, (2) commission the National Academy of Sciences to peer review an agency draft scientific information product, or (3) employ an alternative procedure or set of procedures, specifically approved by the OIRA Administrator in consultation with the Office of Science and Technology Policy (OSTP), that ensures that the scientific information product meets applicable information-quality standards.

An example of an alternative procedure is to commission a respected third party other than the NAS ( e.g. , the Health Effects Institute or the National Commission on Radiation Protection and Measurement) to conduct an assessment or series of related assessments. Another example of an alternative set of procedures is the three-part process used by the National Institutes of Health (NIH) to generate scientific guidance. Under that process, a scientific proposal or white paper is generated by a working group composed of external, independent scientific experts; that paper is then forwarded to a separate external scientific council, which then makes recommendations to the agency. The agency, in turn, decides whether to adopt and/or modify the proposal. For large science agencies that have diverse research portfolios and do not have significant regulatory responsibilities, such as NIH, an acceptable alternative would be to allow scientists from one part of the agency (for example, an NIH institute) to participate in the review of documents prepared by another part of the agency, as long as the head of the agency confirms in writing that each of the reviewers meets the NAS criteria relating to the appropriateness of using employees of sponsors ( e.g. , the government scientist must not have had any part in the development or prior review of the scientific information and must not hold a position of managerial or policy responsibility). The purpose of Section IV is to encourage these types of innovation in the methods used to ensure pre-dissemination quality control of influential scientific information.

The mere existence of a public comment process ( e.g. , notice-and-comment procedures under the Administrative Procedure Act) does not constitute adequate peer review or an “alternative process,” because it does not assure that qualified, impartial specialists in relevant fields have performed a critical evaluation of the agency's draft product. 29

Section V requires agencies to begin a systematic process of peer review planning for influential scientific information (including highly influential scientific assessments) that the agency plans to disseminate in the foreseeable future. A key feature of this planning process is a Web-accessible listing of forthcoming influential scientific disseminations (i.e., an agenda) that is regularly updated by the agency. By making these plans publicly available, agencies will be able to gauge the extent of public interest in the peer review process for influential scientific information, including highly influential scientific assessments. These Web-accessible agendas can also be used by the public to monitor agency compliance with this Bulletin.

Each entry on the agenda shall include a preliminary title of the planned report, a short paragraph describing the subject and purpose of the planned report, and an agency contact person. The agency shall provide its prediction regarding whether the dissemination will be “influential scientific information” or a “highly influential scientific assessment,” as the designation can influence the type of peer review to be undertaken. The agency shall discuss the timing of the peer review, as well as the use of any deferrals. Agencies shall include entries in the agenda for influential scientific information, including highly influential scientific assessments, for which the Bulletin's requirements have been deferred or waived. If the agency, in consultation with the OIRA Administrator, has determined that it is appropriate to use a Section IV “alternative procedure” for a specific dissemination, a description of that alternative procedure shall be included in the agenda.

Furthermore, for each entry on the agenda, the agency shall describe the peer review plan. Each peer review plan shall include: (i) A paragraph including the title, subject and purpose of the planned report, as well as an agency contact to whom inquiries may be directed to learn the specifics of the plan; (ii) whether the dissemination is likely to be influential scientific information or a highly influential scientific assessment; (iii) the timing of the review (including deferrals); (iv) whether the review will be conducted through a panel or individual letters (or whether an alternative procedure will be exercised); (v) whether there will be opportunities for the public to comment on the work product to be peer reviewed, and if so, how and when these opportunities will be provided; (vi) whether the agency will provide significant and relevant public comments to the peer reviewers before they conduct their review; (vii) the anticipated number of reviewers (3 or fewer; 4-10; or more than 10); (viii) a succinct description of the primary disciplines or expertise needed in the review; (ix) whether reviewers will be selected by the agency or by a designated outside organization; and (x) whether the public, including scientific or professional societies, will be asked to nominate potential peer reviewers. The agency shall provide a link from the agenda to each document made public pursuant to this Bulletin. Agencies shall link their peer review agendas to the U.S. Government's official Web portal: firstgov at http://www.FirstGov.gov.

Agencies should update their peer review agendas at least every six months. However, in some cases—particularly for highly influential scientific assessments and other particularly important information—more frequent updates of existing entries on the agenda, or the addition of new entries to the agenda, may be warranted. When new entries are added to the agenda of forthcoming reports and other information, the public should be provided with sufficient time to comment on the agency's peer review plan for that report or product. Agencies shall consider public comments on the peer review plan. Agencies are encouraged to offer a listserve or similar mechanism for members of the public who would like to be notified by email each time an agency's peer review agenda has been updated.

The peer review planning requirements of this Bulletin are designed to be implemented in phases. Specifically, the planning requirements of the Bulletin will go into effect for documents subject to Section III of the Bulletin (highly influential scientific assessments) six months after publication. However, the planning requirements for documents subject to Section II of the Bulletin do not go into effect until one year after publication. It is expected that agency experience with the planning requirements of the Bulletin for the smaller scope of documents encompassed in Section III will be used to inform implementation of these planning requirements for the larger scope of documents covered under Section II.

Each agency shall prepare an annual report that summarizes key decisions made pursuant to this Bulletin. In particular, each agency should provide to OIRA the following: (1) The number of peer reviews conducted subject to the Bulletin (i.e., for influential scientific information and highly influential scientific assessments); (2) the number of times alternative procedures were invoked; (3) the number of times waivers or deferrals were invoked (and in the case of deferrals, the length of time elapsed between the deferral and the peer review); (4) any decision to appoint a reviewer pursuant to any exception to the applicable independence or conflict of interest standards of the Bulletin, including determinations by the Secretary or Deputy Secretary pursuant to Section III(3)(c); (5) the number of peer review panels that were conducted in public and the number that allowed public comment; (6) the number of public comments provided on the agency's peer review plans; and (7) the number of peer reviewers that the agency used that were recommended by professional societies.

If an agency relies on influential scientific information or a highly influential scientific assessment subject to the requirements of this Bulletin in support of a regulatory action, the agency shall include in the administrative record for that action a certification that explains how the agency has complied with the requirements of this Bulletin and the Information Quality Act. Relevant materials are to be placed in the administrative record.

Section VIII recognizes that individuals serving as peer reviewers have a privacy interest in information about themselves that the government maintains and retrieves by name or identifier from a system of records. To the extent information about a reviewer (name, credential, affiliation) will be disclosed along with his/her comments or analysis, the agency must comply with the requirements of the Privacy Act, 5 U.S.C. 552a, as amended, and OMB Circular A-130, Appendix I, 61 FR 6428 (February 20, 1996) to establish appropriate routine uses in a published System of Records Notice. Furthermore, the peer review must be conducted in a manner that respects confidential business information as well as intellectual property.

Section VIII also allows for a deferral or waiver of the requirements of the Bulletin where necessary. Specifically, the agency head may waive or defer some or all of the peer review requirements of Sections II or III of this Bulletin if there is a compelling rationale for waiver or deferral. Waivers will seldom be warranted under this provision because the Bulletin already provides significant safety valves, such as: The exemptions provided in Section IX, including the exemption for time-sensitive health and safety information; the authorization for alternative procedures in Section IV; and the overall flexibility provided for peer reviews of influential scientific information under Section II. Nonetheless, we have included this waiver and deferral provision to ensure needed flexibility in unusual and compelling situations not otherwise covered by the exemptions to the Bulletin, such as situations where unavoidable legal deadlines prevent full compliance with the Bulletin before information is disseminated. Deadlines found in consent decrees agreed to by agencies after the Bulletin is issued will not ordinarily warrant waiver of the Bulletin's requirements because those deadlines should be negotiated to permit time for all required procedures, including peer review. In addition, when an agency is unavoidably up against a deadline, deferral of some or all requirements of the Bulletin (as opposed to outright waiver of all of them) is the most appropriate accommodation between the need to satisfy immovable deadlines and the need to undertake proper peer review. If the agency head defers any of the peer review requirements prior to dissemination, peer review should be conducted as soon as practicable thereafter.

There are a variety of situations where agencies need not conduct peer review under this Bulletin. These include, for example, disseminations of sensitive information related to certain national security, foreign affairs, or negotiations involving international treaties and trade where compliance with this Bulletin would interfere with the need for secrecy or promptness.

This Bulletin does not cover official disseminations that arise in adjudications and permit proceedings, unless the agency determines that peer review is practical and appropriate and that the influential dissemination is scientifically or technically novel (i.e., a major change in accepted practice) or likely to have precedent-setting influence on future adjudications or permit proceedings. This exclusion is intended to cover, among other things, licensing, approval and registration processes for specific product development activities as well as site-specific activities. The determination as to whether peer review is practical and appropriate is left to the discretion of the agency. While this Bulletin is not broadly applicable to adjudications, agencies are encouraged to hold peer reviews of scientific assessments supporting adjudications to the same technical standards as peer reviews covered by the Bulletin, including transparency and disclosure of the data and models underlying the assessments. Protections apply to confidential business information.

The Bulletin does not cover time-sensitive health and safety disseminations, for example, a dissemination based primarily on data from a recent clinical trial that was adequately peer reviewed before the trial began. For this purpose, “health” includes public health, or plant or animal infectious diseases.

This Bulletin covers original data and formal analytic models used by agencies in Regulatory Impact Analyses (RIAs). However, the RIA documents themselves are already reviewed through an interagency review process under E.O. 12866 that involves application of the principles and methods defined in OMB Circular A-4. In that respect, RIAs are excluded from coverage by this Bulletin, although agencies are encouraged to have RIAs reviewed by peers within the government for adequacy and completeness.

The Bulletin does not cover accounting, budget, actuarial, and financial information including that which is generated or used by agencies that focus on interest rates, banking, currency, securities, commodities, futures, or taxes.

Routine statistical information released by Federal statistical agencies ( e.g. , periodic demographic and economic statistics) and analyses of these data to compute standard indicators and trends ( e.g. , unemployment and poverty rates) is excluded from this Bulletin.

The Bulletin does not cover information disseminated in connection with routine rules that materially alter entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients thereof.

If information is disseminated pursuant to an exemption to this Bulletin, subsequent disseminations are not automatically exempted. For example, if influential scientific information is first disseminated in the course of an exempt agency adjudication, but is later disseminated in the context of a non-exempt rulemaking, the subsequent dissemination will be subject to the requirements of this Bulletin even though the first dissemination was not.

OIRA, in consultation with OSTP, is responsible for overseeing agency implementation of this Bulletin. In order to foster learning about peer review practices across agencies, OIRA and OSTP shall form an interagency workgroup on peer review that meets regularly, discusses progress and challenges, and recommends improvements to peer review practices.

The requirements of this Bulletin, with the exception of Section V, apply to information disseminated on or after six months after publication of this Bulletin. However, the Bulletin does not apply to information that is already being addressed by an agency-initiated peer review process ( e.g. , a draft is already being reviewed by a formal scientific advisory committee established by the agency). An existing peer review mechanism mandated by law should be implemented by the agency in a manner as consistent as possible with the practices and procedures outlined in this Bulletin. The requirements of Section V apply to “highly influential scientific assessments,” as designated in Section III of the Bulletin, within six months of publication of the final Bulletin. The requirements in Section V apply to documents subject to Section II of the Bulletin one year after publication of the final Bulletin.

This Bulletin is intended to improve the internal management of the Executive Branch and is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity, against the United States, its agencies or other entities, its officers or employees, or any other person.

For purposes of this Bulletin—

1. The term “Administrator” means the Administrator of the Office of Information and Regulatory Affairs in the Office of Management and Budget (OIRA);

2. The term “agency” has the same meaning as in the Paperwork Reduction Act, 44 U.S.C. 3502(1);

3. The term “dissemination” means agency initiated or sponsored distribution of information to the public (see 5 CFR 1320.3(d) (definition of “Conduct or Sponsor”)). Dissemination does not include distribution limited to government employees or agency contractors or grantees; intra- or inter-agency use or sharing of government information; or responses to requests for agency records under the Freedom of Information Act, the Privacy Act, the Federal Advisory Committee Act, the Government Performance and Results Act or similar law. This definition also excludes distribution limited to correspondence with individuals or persons, press releases, archival records, public filings, subpoenas and adjudicative processes. The term “dissemination” also excludes information distributed for peer review in compliance with this Bulletin, provided that the distributing agency includes a clear disclaimer on the information as follows: “This information is distributed solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. It has not been formally disseminated by [the agency]. It does not represent and should not be construed to represent any agency determination or policy.” For the purposes of this Bulletin, “dissemination” excludes research produced by government-funded scientists ( e.g. , those supported extramurally or intramurally by Federal agencies or those working in state or local governments with Federal support) if that information does not represent the views of an agency. To qualify for this exemption, the information should display a clear disclaimer that “the findings and conclusions in this report are those of the author(s) and do not necessarily represent the views of the funding agency”;

4. The term “Information Quality Act” means Section 515 of Public Law 106-554 (Pub. L. No. 106-554, § 515, 114 Stat. 2763, 2763A-153-154 (2000));

5. The term “scientific information” means factual inputs, data, models, analyses, technical information, or scientific assessments based on the behavioral and social sciences, public health and medical sciences, life and earth sciences, engineering, or physical sciences. This includes any communication or representation of knowledge such as facts or data, in any medium or form, including textual, numerical, graphic, cartographic, narrative, or audiovisual forms. This definition includes information that an agency disseminates from a Web page, but does not include the provision of hyperlinks to information that others disseminate. This definition does not include opinions, where the agency's presentation makes clear that what is being offered is someone's opinion rather than fact or the agency's views;

6. The term “influential scientific information” means scientific information the agency reasonably can determine will have or does have a clear and substantial impact on important public policies or private sector decisions; and

7. The term “scientific assessment” means an evaluation of a body of scientific or technical knowledge, which typically synthesizes multiple factual inputs, data, models, assumptions, and/or applies best professional judgment to bridge uncertainties in the available information. These assessments include, but are not limited to, state-of-science reports; technology assessments; weight-of-evidence analyses; meta-analyses; health, safety, or ecological risk assessments; toxicological characterizations of substances; integrated assessment models; hazard determinations; or exposure assessments.

1. In General: To the extent permitted by law, each agency shall conduct a peer review on all influential scientific information that the agency intends to disseminate. Peer reviewers shall be charged with reviewing scientific and technical matters, leaving policy determinations for the agency. Reviewers shall be informed of applicable access, objectivity, reproducibility and other quality standards under the Federal laws governing information access and quality.

2. Adequacy of Prior Peer Review: For information subject to this section of the Bulletin, agencies need not have further peer review conducted on information that has already been subjected to adequate peer review. In determining whether prior peer review is adequate, agencies shall give due consideration to the novelty and complexity of the science to be reviewed, the importance of the information to decision making, the extent of prior peer reviews, and the expected benefits and costs of additional review. Principal findings, conclusions and recommendations in official reports of the National Academy of Sciences are generally presumed to have been adequately peer reviewed.

3. Selection of Reviewers: a. Expertise and Balance: Peer reviewers shall be selected based on expertise, experience and skills, including specialists from multiple disciplines, as necessary. The group of reviewers shall be sufficiently broad and diverse to fairly represent the relevant scientific and technical perspectives and fields of knowledge. Agencies shall consider requesting that the public, including scientific and professional societies, nominate potential reviewers.

b. Conflicts: The agency—or the entity selecting the peer reviewers—shall (i) ensure that those reviewers serving as federal employees (including special government employees) comply with applicable Federal ethics requirements; (ii) in selecting peer reviewers who are not government employees, adopt or adapt the National Academy of Sciences policy for committee selection with respect to evaluating the potential for conflicts ( e.g. , those arising from investments; agency, employer, and business affiliations; grants, contracts and consulting income). For scientific information relevant to specific regulations, the agency shall examine a reviewer's financial ties to regulated entities ( e.g. , businesses), other stakeholders, and the agency.

c. Independence: Peer reviewers shall not have participated in development of the work product. Agencies are encouraged to rotate membership on standing panels across the pool of qualified reviewers. Research grants that were awarded to scientists based on investigator-initiated, competitive, peer-reviewed proposals generally do not raise issues as to independence or conflicts.

4. Choice of Peer Review Mechanism: The choice of a peer review mechanism (for example, letter reviews or ad hoc panels) for influential scientific information shall be based on the novelty and complexity of the information to be reviewed, the importance of the information to decision making, the extent of prior peer review, and the expected benefits and costs of review, as well as the factors regarding transparency described in II(5).

5. Transparency: The agency—or entity managing the peer review—shall instruct peer reviewers to prepare a report that describes the nature of their review and their findings and conclusions. The peer review report shall either (a) include a verbatim copy of each reviewer's comments (either with or without specific attributions) or (b) represent the views of the group as a whole, including any disparate and dissenting views. The agency shall disclose the names of the reviewers and their organizational affiliations in the report. Reviewers shall be notified in advance regarding the extent of disclosure and attribution planned by the agency. The agency shall disseminate the final peer review report on the agency's Web site along with all materials related to the peer review (any charge statement, the peer review report, and any agency response). The peer review report shall be discussed in the preamble to any related rulemaking and included in the administrative record for any related agency action.

6. Management of Peer Review Process and Reviewer Selection: The agency may commission independent entities to manage the peer review process, including the selection of peer reviewers, in accordance with this Bulletin.

1. Applicability: This section applies to influential scientific information that the agency or the Administrator determines to be a scientific assessment that:

(i) Could have a potential impact of more than $500 million in any year, or

(ii) Is novel, controversial, or precedent-setting or has significant interagency interest.

2. In General: To the extent permitted by law, each agency shall conduct peer reviews on all information subject to this Section. The peer reviews shall satisfy the requirements of Section II of this Bulletin, as well as the additional requirements found in this Section. Principal findings, conclusions and recommendations in official reports of the National Academy of Sciences that fall under this Section are generally presumed not to require additional peer review.

3. Selection of Reviewers: a. Expertise and Balance: Peer reviewers shall be selected based on expertise, experience and skills, including specialists from multiple disciplines, as necessary. The group of reviewers shall be sufficiently broad and diverse to fairly represent the relevant scientific and technical perspectives and fields of knowledge. Agencies shall consider requesting that the public, including scientific and professional societies, nominate potential reviewers.

b. Conflicts: The agency—or the entity selecting the peer reviewers—shall (i) ensure that those reviewers serving as Federal employees (including special government employees) comply with applicable Federal ethics requirements; (ii) in selecting peer reviewers who are not government employees, adopt or adapt the National Academy of Sciences' policy for committee selection with respect to evaluating the potential for conflicts ( e.g. , those arising from investments; agency, employer, and business affiliations; grants, contracts and consulting income). For scientific assessments relevant to specific regulations, a reviewer's financial ties to regulated entities ( e.g. , businesses), other stakeholders, and the agency shall be examined.

c. Independence: In addition to the requirements of Section II (3)(c), which shall apply to all reviews conducted under Section III, the agency—or entity selecting the reviewers—shall bar participation of scientists employed by the sponsoring agency unless the reviewer is employed only for the purpose of conducting the peer review ( i.e. , special government employees). The only exception to this bar would be the rare case where the agency determines, using the criteria developed by NAS for evaluating use of “employees of sponsors,” that a premier government scientist is (a) not in a position of management or policy responsibility and (b) possesses essential expertise that cannot be obtained elsewhere. Furthermore, to be eligible for this exception, the scientist must be employed by a different agency of the Cabinet-level department than the agency that is disseminating the scientific information. The agency's determination shall be documented in writing and approved, on a non-delegable basis, by the Secretary or Deputy Secretary of the department prior to the scientist's appointment.

d. Rotation: Agencies shall avoid repeated use of the same reviewer on multiple assessments unless his or her participation is essential and cannot be obtained elsewhere.

4. Information Access: The agency—or entity managing the peer review—shall provide the reviewers with sufficient information—including background information about key studies or models—to enable them to understand the data, analytic procedures, and assumptions used to support the key findings or conclusions of the draft assessment.

5. Opportunity for Public Participation: Whenever feasible and appropriate, the agency shall make the draft scientific assessment available to the public for comment at the same time it is submitted for peer review (or during the peer review process) and sponsor a public meeting where oral presentations on scientific issues can be made to the peer reviewers by interested members of the public. When employing a public comment process as part of the peer review, the agency shall, whenever practical, provide peer reviewers with access to public comments that address significant scientific or technical issues. To ensure that public participation does not unduly delay agency activities, the agency shall clearly specify time limits for public participation throughout the peer review process.

6. Transparency: In addition to the requirements specified in II(5), which shall apply to all reviews conducted under Section III, the peer review report shall include the charge to the reviewers and a short paragraph on both the credentials and relevant experiences of each peer reviewer. The agency shall prepare a written response to the peer review report explaining (a) the agency's agreement or disagreement with the views expressed in the report, (b) the actions the agency has undertaken or will undertake in response to the report, and (c) the reasons the agency believes those actions satisfy the key concerns stated in the report (if applicable). The agency shall disseminate its response to the peer review report on the agency's Web site with the related material specified in Section II(5).

7. Management of Peer Review Process and Reviewer Selection: The agency may commission independent entities to manage the peer review process, including the selection of peer reviewers, in accordance with this Bulletin.

As an alternative to complying with Sections II and III of this Bulletin, an agency may instead: (i) Rely on the principal findings, conclusions and recommendations of a report produced by the National Academy of Sciences; (ii) commission the National Academy of Sciences to peer review an agency's draft scientific information; or (iii) employ an alternative scientific procedure or process, specifically approved by the Administrator in consultation with the Office of Science and Technology Policy (OSTP), that ensures the agency's scientific information satisfies applicable information quality standards. The alternative procedure(s) may be applied to a designated report or group of reports.

1. Peer Review Agenda: Each agency shall post on its Web site, and update at least every six months, an agenda of peer review plans. The agenda shall describe all planned and ongoing influential scientific information subject to this Bulletin. The agency shall provide a link from the agenda to each document that has been made public pursuant to this Bulletin. Agencies are encouraged to offer a listserve or similar mechanism to alert interested members of the public when entries are added or updated.

2. Peer Review Plans: For each entry on the agenda the agency shall describe the peer review plan. Each peer review plan shall include: (i) A paragraph including the title, subject and purpose of the planned report, as well as an agency contact to whom inquiries may be directed to learn the specifics of the plan; (ii) whether the dissemination is likely to be influential scientific information or a highly influential scientific assessment; (iii) the timing of the review (including deferrals); (iv) whether the review will be conducted through a panel or individual letters (or whether an alternative procedure will be employed); (v) whether there will be opportunities for the public to comment on the work product to be peer reviewed, and if so, how and when these opportunities will be provided; (vi) whether the agency will provide significant and relevant public comments to the peer reviewers before they conduct their review; (vii) the anticipated number of reviewers (3 or fewer; 4-10; or more than 10); (viii) a succinct description of the primary disciplines or expertise needed in the review; (ix) whether reviewers will be selected by the agency or by a designated outside organization; and (x) whether the public, including scientific or professional societies, will be asked to nominate potential peer reviewers.

3. Public Comment: Agencies shall establish a mechanism for allowing the public to comment on the adequacy of the peer review plans. Agencies shall consider public comments on peer review plans.

Each agency shall provide to OIRA, by December 15 of each year, a summary of the peer reviews conducted by the agency during the fiscal year. The report should include the following: (1) The number of peer reviews conducted subject to the Bulletin ( i.e. , for influential scientific information and highly influential scientific assessments); (2) the number of times alternative procedures were invoked; (3) the number of times waivers or deferrals were invoked (and in the case of deferrals, the length of time elapsed between the deferral and the peer review); (4) any decision to appoint a reviewer pursuant to any exception to the applicable independence or conflict of interest standards of the Bulletin, including determinations by the Secretary pursuant to Section III(3)(c); (5) the number of peer review panels that were conducted in public and the number that allowed public comment; (6) the number of public comments provided on the agency's peer review plans; and (7) the number of peer reviewers that the agency used that were recommended by professional societies.

If an agency relies on influential scientific information or a highly influential scientific assessment subject to this Bulletin to support a regulatory action, it shall include in the administrative record for that action a certification explaining how the agency has complied with the requirements of this Bulletin and the applicable information quality guidelines. Relevant materials shall be placed in the administrative record.

1. Privacy: To the extent information about a reviewer (name, credentials, affiliation) will be disclosed along with his/her comments or analysis, the agency shall comply with the requirements of the Privacy Act, 5 U.S.C. 522a as amended, and OMB Circular A-130, Appendix I, 61 FR 6428 (February 20, 1996) to establish appropriate routine uses in a published System of Records Notice.

2. Confidentiality: Peer review shall be conducted in a manner that respects (i) confidential business information and (ii) intellectual property.

3. Deferral and Waiver: The agency head may waive or defer some or all of the peer review requirements of Sections II and III of this Bulletin where warranted by a compelling rationale. If the agency head defers the peer review requirements prior to dissemination, peer review shall be conducted as soon as practicable.

Agencies need not have peer review conducted on information that is:

1. Related to certain national security, foreign affairs, or negotiations involving international trade or treaties where compliance with this Bulletin would interfere with the need for secrecy or promptness;

2. Disseminated in the course of an individual agency adjudication or permit proceeding (including a registration, approval, licensing, site-specific determination), unless the agency determines that peer review is practical and appropriate and that the influential dissemination is scientifically or technically novel or likely to have precedent-setting influence on future adjudications and/or permit proceedings;

3. A health or safety dissemination where the agency determines that the dissemination is time-sensitive ( e.g. , findings based primarily on data from a recent clinical trial that was adequately peer reviewed before the trial began);

4. An agency regulatory impact analysis or regulatory flexibility analysis subject to interagency review under Executive Order 12866, except for underlying data and analytical models used;

5. Routine statistical information released by federal statistical agencies ( e.g. , periodic demographic and economic statistics) and analyses of these data to compute standard indicators and trends ( e.g. , unemployment and poverty rates);

6. Accounting, budget, actuarial, and financial information, including that which is generated or used by agencies that focus on interest rates, banking, currency, securities, commodities, futures, or taxes; or

7. Information disseminated in connection with routine rules that materially alter entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients thereof.

OIRA, in consultation with OSTP, shall be responsible for overseeing implementation of this Bulletin. An interagency group, chaired by OSTP and OIRA, shall meet periodically to foster better understanding about peer review practices and to assess progress in implementing this Bulletin.

The requirements of this Bulletin, with the exception of those in Section V (Peer Review Planning), apply to information disseminated on or after six months following publication of this Bulletin, except that they do not apply to information for which an agency has already provided a draft report and an associated charge to peer reviewers. Any existing peer review mechanisms mandated by law shall be employed in a manner as consistent as possible with the practices and procedures laid out herein. The requirements in Section V apply to “highly influential scientific assessments,” as designated in Section III of this Bulletin, within six months of publication of this Bulletin. The requirements in Section V apply to documents subject to Section II of this Bulletin one year after publication of this Bulletin.

This Bulletin is intended to improve the internal management of the executive branch, and is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity, against the United States, its agencies or other entities, its officers or employees, or any other person.