The regulations in 7 CFR 301.50 through 301.50-10 (referred to below as the regulations) restrict the interstate movement of certain regulated articles from quarantined areas in order to prevent the spread of pine shoot beetle (PSB) into noninfested areas of the United States.

PSB is a pest of pine trees that can cause damage in weak and dying trees, where reproduction and immature stages of PSB occur. During “maturation feeding,” young beetles tunnel into the center of pine shoots (usually of the current year's growth), causing stunted and distorted growth in host trees. PSB is also a vector of several diseases of pine trees. Factors that may result in the establishment of PSB populations far from the location of the original host tree include: (1) Adults can fly at least 1 kilometer, and (2) infested trees and pine products are often transported long distances. This pest damages urban ornamental trees and can cause economic losses to the timber, Christmas tree, and nursery industries.

PSB hosts include all pine species. The beetle has been found in a variety of pine species ( Pinus spp.) in the United States. Scotch pine ( P. sylvestris ) is the preferred host of PSB. The Animal and Plant Health Inspection Service (APHIS) has determined, based on scientific data from European countries, that fir ( Abies spp.,) larch ( Larix spp.,) and spruce ( Picea spp.) are not hosts of PSB.

Surveys conducted by State and Federal inspectors revealed areas within 37 additional counties infested with PSB in 8 States (Illinois, Indiana, Maryland, New York, Ohio, Pennsylvania, Vermont, and Virginia). Copies of the surveys may be obtained by writing to the individual listed under FOR FURTHER INFORMATION CONTACT .

The regulations in § 301.50-3 provide that the Administrator of APHIS will list as a quarantined area each State, or each portion of a State, in which PSB has been found by an inspector, in which the Administrator has reason to believe PSB is present, or that the Administrator considers necessary to regulate because of its inseparability for quarantine enforcement purposes from localities in which PSB has been found.

In accordance with these criteria, we are designating Carroll, Clark, Coles, Ford, Henry, Mason, Moultrie, Peoria, and Shelby Counties, IL; Bartholomew, Franklin, Monroe, Morgan, Putnam, and Union Counties, IN; Montgomery County, MD; Albany, Fulton, Greene, Hamilton, Herkimer, Montgomery, Saratoga, Schenectady, Schoharie, and Sullivan Counties, NY; Athens, Gallia, Pike, and Washington Counties, OH; Centre, Fulton, Lycoming, Susquehanna, and Wyoming Counties, PA; Washington County, VT; and Clarke County, VA, as quarantined areas, and we are adding them to the list of quarantined areas in § 301.50-3(c).

Entities affected by this interim rule may include nursery stock growers, Christmas tree farms, logging operations, and others who sell, process, or move regulated articles. As a result of this interim rule, any regulated articles to be moved interstate from a quarantined area must first be inspected and/or treated in order to qualify for a certificate or limited permit authorizing the movement.

We are removing paragraph (d) of § 301.50-3 from the regulations. Paragraph (d) contains a map that shows the quarantined counties listed in § 301.50-3(c). The map does not add any information to the regulations; therefore, we have decided not to recreate it each time the list of quarantined areas is changed.

This rulemaking is necessary on an emergency basis to prevent PSB from spreading to noninfested areas of the United States. Under these circumstances, the Administrator has determined that prior notice and opportunity for public comment are contrary to the public interest and that there is good cause under 5 U.S.C. 553 for making this rule effective less than 30 days after publication in the Federal Register .

We will consider comments we receive during the comment period for this interim rule (see DATES above). After the comment period closes, we will publish another document in the Federal Register . The document will include a discussion of any comments we receive and any amendments we are making to the rule.

This rule has been reviewed under Executive Order 12866. For this action, the Office of Management and Budget has waived its review under Executive Order 12866.

This emergency situation makes timely compliance with section 604 of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) impracticable. We are currently assessing the potential economic effects of this action on small entities. Based on that assessment, we will either certify that the rule will not have a significant economic impact on a substantial number of small entities or publish a final regulatory flexibility analysis.

This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 7 CFR part 3015, subpart V.)

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts all State and local laws and regulations that are inconsistent with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule.

This interim rule contains no information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

Background

Karnal bunt is a fungal disease of wheat ( Triticum aestivum ), durum wheat ( Triticum durum ), and triticale ( Triticum aestivum X Secale cereale ), a hybrid of wheat and rye. Karnal bunt is caused by the smut fungus Tilletia indica (Mitra) Mundkur and is spread primarily through the movement of infected seed. Some countries in the international wheat market regulate Karnal bunt as a fungal disease requiring quarantine; therefore, without measures taken by the Animal and Plant Health Inspection Service (APHIS), United States Department of Agriculture, to prevent its spread, the presence of Karnal bunt in the United States could have significant consequences with regard to the export of wheat to international markets.

Upon detection of Karnal bunt in Arizona in March of 1996, Federal quarantine and emergency actions were imposed to prevent the interstate spread of the disease to other wheat producing areas in the United States. The quarantine continues in effect, although it has since been modified, both in terms of its physical boundaries and in terms of its restrictions on the production and movement of regulated articles from regulated areas. The regulations regarding Karnal bunt are set forth in 7 CFR 301.89-1 through 301.89-16 (referred to below as the regulations).

The regulations in § 301.89-3(e) provide that we will classify a field or area as a regulated area when it is:

• A field planted with seed from a lot found to contain a bunted wheat kernel;

• A distinct definable area that contains at least one field that was found during a survey to contain a bunted wheat kernel. The distinct definable area may include an area where Karnal bunt is not known to exist but where intensive surveys are required because of the areas's proximity to a field found during survey to contain a bunted wheat kernel; or

• A distinct definable area that contains at least one field that was found during survey to contain spores consistent with Karnal bunt and has been determined to be associated with grain at a handling facility containing a bunted wheat kernel. The distinct definable area may include an area where Karnal bunt is not known to exist but where intensive surveys are required because of that area's proximity to a field that has been associated with grain at a handling facility containing a bunted wheat kernel.

The boundaries of distinct definable areas are determined using the criteria in paragraphs (b) through (d) of § 301.89-3, which provide for the regulation of less than an entire State, the inclusion of noninfected acreage in a regulated area, and the temporary designation of nonregulated areas as regulated areas. Paragraph (c) of § 301.89-3 states that the Administrator may include noninfected acreage within a regulated area due to its proximity to an infestation or inseparability from the infected locality for regulatory purposes, as determined by:

• Projections of the spread of Karnal bunt along the periphery of the infestation;

• The availability of natural habitats and host materials within the noninfected acreage that are suitable for establishment and survival of Karnal bunt; and

• The necessity of including noninfected acreage within the regulated area in order to establish readily identifiable boundaries.

When we include noninfected acreage in a regulated area for one or more of the reasons previously listed, the noninfected acreage, along with the rest of the acreage in the regulated area, is intensively surveyed. Negative results from surveys of the noninfected acreage provide assurance that all infected acreage is within the regulated area. In effect, the noninfected acreage serves as a buffer zone between fields or areas affected with Karnal bunt and areas outside of the regulated area.

The regulations in § 301.89-3(f) describe the boundaries of the regulated areas in Arizona, California, and Texas. Certain regulated areas include noninfected acreage that functions as a buffer zone to guard against the spread of Karnal bunt. Our current policy is to utilize a 3-mile-wide buffer zone around fields or areas affected with Karnal bunt. Based on over 7 years of experience surveying noninfected acreage included in regulated areas, we have determined that a buffer zone of no more than 3 miles is sufficient.

In this interim rule, we are amending § 301.89-3(f) by modifying the list of regulated areas associated with Karnal bunt. Specifically, we are adding certain areas in Arizona to the list of regulated areas either because the fields within those areas were found during detection and delineating surveys to contain a bunted wheat kernel, or because the fields within those areas fall within the 3-mile-wide buffer zone around fields affected with Karnal bunt. This action is necessary in order to help prevent the spread of Karnal bunt into noninfected areas of the United States.

As part of this same rule, we are also removing certain areas from the list of regulated areas in California because recently completed detection and delineating surveys show them to be free of Karnal bunt. This action relieves restrictions on those areas that are no longer warranted.

The list of regulated areas in Arizona includes individual fields and other distinct definable areas located in La Paz, Maricopa, and Pinal Counties. In this interim rule, we are adding new regulated areas in Maricopa and Pinal Counties due to the detection of bunted wheat kernels there or as a result of the application of the 3-mile-wide buffer zone around fields affected with Karnal bunt. These additional regulated areas in Maricopa and Pinal Counties involve approximately 2,589 acres (57 fields).

We are removing from the list of regulated areas in California a total of 42,802 acres (1,093 fields) located in the Palo Verde Valley of eastern Riverside County. Bunted kernels have never been found in the fields of the Palo Verde Valley that we are deregulating; these fields had been designated as regulated areas based on the detection of spores in the fields and the fields' association with bunted kernels found in a storage facility. As an additional safeguard, the California Department of Food and Agriculture (CDFA) plant pathologists routinely perform size-selective sieving prior to examination for bunted kernels. CDFA has not found spores present in samples that had no bunted kernels. We believe that this data allows us to deregulate these 1,093 fields.

In addition, all 1,093 fields have been used to grow non-host, cultivated crops since the time they were placed under regulation. All of the fields have been cultivated no fewer than 9 times, with some having been cultivated 25 times over the course of 6 seasons.

This rulemaking is necessary on an immediate basis to help prevent Karnal bunt from spreading to noninfected areas of the United States. This rule will also relieve restrictions on certain fields or areas that are no longer warranted. Under these circumstances, the Administrator has determined that prior notice and opportunity for public comment are contrary to the public interest and that there is good cause under 5 U.S.C. 553 for making this rule effective less than 30 days after publication in the Federal Register .

We will consider comments we receive during the comment period for this interim rule (see DATES above). After the comment period closes, we will publish another document in the Federal Register . The document will include a discussion of any comments we receive and any amendments we are making to the rule.

This rule has been reviewed under Executive Order 12866. For this action, the Office of Management and Budget has waived its review under Executive Order 12866.

This emergency situation makes timely compliance with section 604 of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) impracticable. We are currently assessing the potential economic effects of this action on small entities. Based on that assessment, we will either certify that the rule will not have a significant economic impact on a substantial number of small entities or publish a final regulatory flexibility analysis.

This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 7 CFR part 3015, subpart V.)

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts all State and local laws and regulations that are inconsistent with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule.

This rule contains no new information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The golden nematode ( Globodera rostochiensis ) is a destructive pest of potatoes and other solanaceous plants. Potatoes cannot be economically grown on land which contains large numbers of the nematode. The golden nematode has been determined to occur in the United States only in parts of New York.

The golden nematode regulations (contained in 7 CFR 301.85 through 301.85-10 and referred to below as the regulations) list two entire counties and portions of seven other counties in the State of New York as regulated areas and restrict the interstate movement of regulated articles from those areas. Such restrictions are necessary to prevent the artificial spread of the golden nematode to noninfested areas of the United States.

Regulated areas are those areas in which the golden nematode has been found or in which there is reason to believe that the golden nematode is present, or those areas which it is deemed necessary to regulate because of their proximity to infestation or their inseparability for quarantine enforcement purposes from infested localities. The regulations provide that less than an entire State may be designated as a regulated area only if the Deputy Administrator determines that the State has adopted and is enforcing a quarantine or regulation that imposes restrictions on the intrastate movement of the regulated articles that are substantially the same as those that are imposed with respect to the interstate movement of the articles and the designation of less than the entire State as a regulated area will otherwise be adequate to prevent the artificial interstate spread of the golden nematode.

Regulated areas are divided into suppressive areas and generally infested areas. Suppressive areas are regulated areas where eradication of the golden nematode is undertaken as an objective. Generally infested areas are regulated areas not designated as suppressive areas. Restrictions are imposed on the interstate movement of regulated articles from generally infested areas and suppressive areas in order to prevent the infestation of areas where the golden nematode does not occur.

Recent surveys conducted by inspectors of the Animal and Plant Health Inspection Service (APHIS) have revealed that an infestation of golden nematode has occurred in one field outside the regulated area in Steuben County, NY. New York has quarantined the infested area and is restricting the intrastate movement of regulated articles from that area to prevent the further spread of golden nematode. However, Federal regulations are necessary to restrict the interstate movement of regulated articles from the regulated areas to prevent the spread of golden nematode to other States and other countries.

In accordance with the criteria for listing regulated areas, we are amending the list of regulated areas in § 301.85-2a to include an additional part of Steuben County, NY, in response to the recent golden nematode findings described above. The regulated area is described in the rule portion of this document. Maps of the regulated area are available by writing to the person listed under FOR FURTHER INFORMATION CONTACT or from local offices of Plant Protection and Quarantine.

In addition to amending the entry for Steuben County, NY, to reflect the addition of a field to the regulated area, we have also divided that entry into subparagraphs so that it is easier to read.

This rulemaking is necessary on an emergency basis to prevent the artificial spread of golden nematode to noninfested areas of the United States. Under these circumstances, the Administrator has determined that prior notice and opportunity for public comment are contrary to the public interest and that there is good cause under 5 U.S.C. 553 for making this rule effective less than 30 days after publication in the Federal Register .

We will consider comments we receive during the comment period for this interim rule (see DATES above). After the comment period closes, we will publish another document in the Federal Register . The document will include a discussion of any comments we receive and any amendments we are making to the rule.

This rule has been reviewed under Executive Order 12866. For this action, the Office of Management and Budget has waived its review under Executive Order 12866.

We are amending the golden nematode regulations by adding a field in Steuben County, NY, to the list of generally infested regulated areas. This action is necessary to prevent the artificial spread of golden nematode to noninfested areas of the United States.

The Regulatory Flexibility Act requires that agencies consider the economic impact of their rules on small entities and to use flexibility to provide regulatory relief when regulations create economic disparities between different sized entities. According to the Small Business Administration's (SBA's) Office of Advocacy, regulations create economic disparities based on size when they have significant economic impact on a substantial number of small entities.

Potato farms are classified as small businesses if they receive less than $750,000 in annual sales receipts. The U.S. Department of Agriculture's National Agricultural Statistics Service does not publish data on farm size for New York potato farms. However, it is likely that the regulated 30-acre farm in Steuben County qualifies as a small business as defined by the SBA.

In the United States, the potato is the leading vegetable in terms of acreage and farm value. About 1.3 million acres are grown for a total production yield of 31.4 billion pounds, worth $2.5 billion in farm receipts. Over 60 percent of U.S. potato production is processed. Growth in the chip market alone has averaged about 11 percent per year over the past 8 years, resulting in a $4 billion industry. The market for exported, processed potatoes is a rapidly growing one.

Golden nematode infestation of potatoes and other solanaceous plants ( e.g. , tomatoes, eggplants) poses a threat to New York's agricultural economy. New York State is the twelfth largest potato producer nationwide, with an average of 25,000 acres of potatoes harvested annually. According to the New York Agricultural Statistics Service, New York State had approximately 22,200 planted acres of potatoes with a production value totaling $64.9 million. About 55 percent of New York State's potato production is destined for the fresh market, 40 percent for processing, and 5 percent for seed and livestock feed. New York State potatoes and potato products are primarily consumed locally and within the northeastern portion of the United States. In 2001, the production value of major solanaceous plants in New York was $92.4 million.

The additional costs associated with our designation of the new regulated area in Steuben County are very small relative to the benefits gained from agricultural sales. For example, the treatment costs for the infected fields are borne by APHIS and not the farmer. The only inconvenience to the farm operator might be that potatoes or any other solanaceous plants may be planted only every other year until the infestation is determined to be over. In the years when potatoes and other solanaceous plants may be planted, farm operators may move such articles without treatment. In the event that the farm operator needs to move farm equipment outside the farm, that equipment must first be treated, either chemically or with steam. The costs of treatment are borne by APHIS. It takes one 8-hour day for a Plant Protection and Quarantine officer and a technician to steam treat farm equipment, including the time required to set up and tear down the treatment site. Since the farm operator does not have to pay for any aspect of this treatment, this rule will not have any adverse economic impact on this farm.

Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action will not have a significant economic impact on a substantial number of small entities.

This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 7 CFR part 3015, subpart V.)

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts all State and local laws and regulations that are inconsistent with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule.

This rule contains no new information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

1. This document corrects the rule amending 7 CFR part 718, Provisions Applicable to Multiple Programs, published in the Federal Register on April 3, 2003 (68 FR 16170) under the Farm Security and Rural Investment Act of 2002 (Public Law 107-171) (the 2002 Act). 7 CFR part 718 governs how FSA monitors marketing quotas, allotments, base acres and acreage reports. The corrections are as follows:

A. Crop definitions. The first correction is in 7 CFR 718.2, adding to the definitions of Extra Long Staple (ELS) Cotton, Rice and Upland cotton the phrase “that follows the standard planting and harvesting practices for the [specific crop] for the area in which the [specific crop] is grown.” This will make the definitions consistent with those for other crops. For example, the definition of corn in § 718.2 includes the phrase “that follows the standard planting and harvesting practices for corn for the area in which the corn is grown * * *” This change clarifies the provision that a program participant cannot receive planting credit for acreage that does not comply with minimum requirements and ensures that it is correctly applied Other clarifying changes are also made.

B. Controlled Substance. The second correction is in 7 CFR 718.6(b)(3), which provides that a person convicted of trafficking in or possession of a controlled substance shall be ineligible for any or all USDA benefits for stated periods of time. This provision is included pursuant to 21 U.S.C. 862, which provides that a court may deny eligibility for certain Federal benefits to an individual convicted of distribution or possession of a controlled substance. “Federal benefit” is defined in 21 U.S.C. 862(d) to mean “any grant, contract, loan, professional license, or commercial license provided by an agency of the United States or by appropriated funds of the United States” but “does not include any retirement, welfare, Social Security, health, disability, veterans benefit, public housing, or other similar benefit, or any other benefit for which payments or services are required for eligibility. The period of ineligibility under this provision is a determination of the court, not FSA. Therefore, section 718.6 is revised by combining paragraph 718.6(b)(3) with paragraph 718.6(b)(2), which already contains the correct provision.

C. Signature Requirements. The third correction is in 7 CFR 718.9(a), which states “When a program authorized by this chapter and parts 1410 and 1413 of this title requires the signature of a producer; landowner; landlord; or tenant, a husband or wife may sign all such FSA or CCC documents on behalf of the other spouse, unless such other spouse has provided written notification to FSA and CCC that such action is not authorized. The notification must be provided to FSA with respect to each farm.” This section is corrected to change “this chapter and parts 1410 and 1413 of” to “this chapter or Chapter XIV of” to insure full coverage in all commodity programs, unless exempted by more specific rules.

2. Quality loss payments for hay. This document corrects 7 CFR part 1480, Crop Disaster Program, published in the Federal Register on June 26, 2003, under the authority of the Agricultural Assistance Act of 2003 (Public Law 108-7) (2003 Act). Section 1480.17(m) states “Quantity adjustments for diminished quality shall also not apply under this section to: Hay, honey, maple sap, turfgrass sod, crops marketed for a use other than an intended use for which there is not an established county price or yield, or any other crop that the Deputy Administrator deems it appropriate to exclude.” This section is being amended to remove the word “hay.” The 2003 Act required CCC to follow section 815 of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2001 (Public Law 106-387; 114 Stat. 1549A-55) (2001 Act), stating that the new program shall use “the same loss thresholds for quantity and quality losses as were administered in that section.” The 2001 Act did not exclude hay from payments for diminished quality. This document amends the rule accordingly.

These changes clarify and correct recently published regulations. Delay of their publication for public comment is unnecessary and contrary to the public interest. Further, 7 U.S.C. 7991(c)(2)(C), and section 217 of Title II, Division N, of Public Law 108-7, exempt these changes from notice and comment rulemaking. So that they may apply equally with existing regulations, these changes are effective as of the original filing of the rules they correct, as described below, implementing the 2002 Act.

The Food Safety and Inspection Service (FSIS) is responsible for carrying out various functions of the Department of Agriculture. Chief among these are the administration of the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq. ), the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq. ), and the Egg Products Inspection Act (EPIA) (21 U.S.C. 1031 et seq. ). Each of these statutes includes provisions that provide for government inspection as part of a regulatory program designed to protect the health and welfare of consumers by preventing the distribution of meat, poultry, and egg products that are unwholesome, otherwise adulterated, or misbranded (21 U.S.C. 451, 455, 602-606, 1031, and 1034).

In this rulemaking, FSIS is continuing its work to update and consolidate various regulatory provisions. This work began with the issuance of a final rule on the organization of the Agency. This rule, for which the public was given an opportunity to submit comments, was published on December 31, 1998 (the 1998 rule) (63 FR 72352). The 1998 rule amended FSIS's regulations in chapter III of title 9 of the Code of Federal Regulations (9 CFR chapter III) by establishing a new part 300 that described FSIS's mission and organization. It also transferred regulations adopted under the EPIA from part 59 of title 7 of the Code of Federal Regulations to part 590 of title 9.

The Agency received only one comment on the 1998 rule. The United Egg Association (UEA) requested that FSIS undertake a more thorough review of the regulations promulgated pursuant to the EPIA. The UEA stated that the current regulatory system was antiquated.

FSIS is conducting a comprehensive review of the EPIA regulations. The Agency anticipates that the review will result in its proposing a number of substantive changes to the EPIA regulations.

In this final rule, the Agency is consolidating and updating various provisions of the regulations issued under the FMIA (9 CFR parts 300, 301, 306, 318, and 320) and the PPIA (9 CFR part 381, subparts A, B, F, O, and Q). The Agency is also adding a section, 300.4, “Organizational terminology; personnel” to part 300. With the addition of this section, part 300 “Agency Mission and Organization”, will contain a description of the part (300.1), a statement about FSIS's responsibilities (300.2), a description of FSIS's organizational structure and personnel (300.3 and 300.4), and rules on the access of government employees to regulated places of business (300.6).

In § 300.1 (Purpose), FSIS is adding a sentence to reflect the fact that part 300 includes rules on the access of government employees to regulated places of business. In paragraph (a) of § 300.2 (FSIS responsibilities), FSIS is adding a sentence that references the Department's delegation of authority regulations (7 CFR 2.7, 2.18, and 2.53). These regulations reference the statutory provisions that the Administrator of FSIS is responsible for administering on behalf of the Secretary of Agriculture.

In § 300.3 (FSIS organization), FSIS is amending paragraph (a) by adding a sentence that states that FSIS implements the inspection provisions of the FMIA, the PPIA, and the EPIA through its field structure. FSIS is also amending paragraphs (b)(1) and (2), and (c)(1) of § 300.3 to reflect the changes that the Agency has made in its headquarters and field organization since publication of the 1998 rule.

FSIS has reorganized its headquarter's offices. FSIS now has eight principal components or offices instead of four. These offices are under the direction of an Assistant Administrator. The Assistant Administrators, along with their staffs and the Office of the Administrator, are still located at the U.S. Department of Agriculture Headquarters in Washington, DC.

FSIS has renamed one of the program offices listed in paragraph (b)(1) of § 300.3. The Office of Policy, Program Development, and Evaluation is now the Office of Policy and Program Development. The functions for this office have also changed. The Office of Policy and Program Development is charged with developing and articulating the Agency's policies regarding food safety and other consumer protections.

FSIS has added four program offices. These offices are the Office of Food Security and Emergency Preparedness (OFSEP), the Office of Program Evaluation, Enforcement, and Review (OPEER), the Office of Public Affairs, Education, and Outreach (OPAEO), and the Office of International Affairs (OIA).

The OFSEP's mission is to prevent or, if necessary, coordinate a response to an intentional attack on the food supply.

The OPEER's primary function is to perform as the Agency's quality assurance program. This staff continually acts as the Agency's eyes and ears to ensure that Agency programs are functioning in an efficient and effective manner.

The OPAEO is responsible for communicating with three main audiences: Congress, constituents, and the media. The OPAEO communications with Congress include everything from preparing testimony for hearings on Capitol Hill to briefing congressional staff on regulatory proposals affecting FSIS. The OPAEO also shares information with, and gathers feedback from, constituents of the Agency and provides newspaper, television and radio reporters accurate and timely information about FSIS's crucial role in protecting public health. The Staff Offices that are currently listed in paragraph (b)(2) of § 300.3 have been reorganized and incorporated into the new Office of Public Affairs, Education, and Outreach.

The OIA is responsible for developing policy and procedures to assure that meat, poultry, and egg products imported into the U.S. are safe, wholesome, unadulterated, properly labeled and packaged, and for facilitating the certification of U.S. meat, poultry, and egg products intended for export.

In addition to the four new program offices described above, the Administrator has created a position titled Special Assistant for Civil Rights. This individual reports directly to the Administrator. The Administrator also has an Executive Assistant and a Codex Manager.

As anticipated in the 1998 rule (63 FR 72352, footnote 1), FSIS has closed its district office in Boston, Massachusetts. The Agency has also reassigned the program responsibilities for the States of Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont to the district office located in Albany, New York, and has reassigned the program responsibilities for Puerto Rico and the Virgin Islands to the district office located in Atlanta, Georgia.

In May 2002, FSIS realigned its district office structure. The realignment resulted in a reduction from 17 districts to 15 districts with 2 satellite offices. The Pickerington, Ohio district office will now be a satellite office and will be serviced by the Chicago, Illinois district office. The State of Kentucky will now be serviced by the Raleigh, North Carolina district office and the State of West Virginia will be serviced by the Beltsville, Maryland district office.

The Salem, Oregon district office will become a satellite office and will be serviced by the Boulder, Colorado district office. The States and areas affected are Alaska, American Samoa, Guam, Hawaii, Idaho, Oregon, and Washington. The State of New Jersey, which was serviced by the Albany, New York district office will now be serviced by the Philadelphia, Pennsylvania district office. FSIS is amending paragraph (c)(1) of § 300.3 to reflect this fact and to correct the address listed for the district office in Maryland which is located in Beltsville, not Greenbelt.

FSIS is including, in paragraph (a) of § 300.4 (Organizational terminology; personnel), updated terminology that combines and replaces the current definitions in § 301.2 of Administrator, Circuit Supervisor, Inspector, Inspector in charge, Program, Program employee, and Secretary; and the current definitions in § 381.1(b) of Administrator, Circuit Supervisor, Inspection Service, Inspection Service employee, Inspection Service supervisor, Inspector, Inspector in Charge, and Secretary.

FSIS also is removing obsolete and unnecessary organizational information and terminology. Provisions that the Agency is deleting include: § 306.1 (Designation of circuit supervisors and assistants); the definitions in § 301.2 of Area, Area Supervisor, Circuit, the Department, Food Safety and Inspection Service, Import Field Office, Import Supervisor, and Regional Director; and the definitions in § 381.1(b) of Department, Import Field Office, and Import Supervisor.

FSIS is addressing several changes in the Agency's organization and the administration of its regulatory functions in paragraph (b) of § 300.4. Section 300.4(b) indicates that the Agency has replaced its regional office and import field office structure with a district office structure, that the authority previously delegated to Regional Directors now is delegated to district managers, and that the authority previously delegated to area supervisors and import supervisors now is delegated to inspection program supervisors in the successor district offices.

In paragraph (b) of § 300.6, FSIS is addressing access to places of business regulated under the FMIA or the PPIA. Paragraph (b)(1) addresses access to establishments that slaughter livestock or otherwise prepare meat products or slaughter poultry or otherwise process poultry products. It replaces the first sentence of § 306.2 and all of § 381.32. Paragraph (b)(2) addresses access to and examinations of facilities, inventories, and records authorized by section 202 of the FMIA and section 11(b) of the PPIA (21 U.S.C. 460(b) and 642). It replaces the first sentences of § 320.4 and § 381.178 (Access to and inspection of records, facilities and inventory; copying and sampling).

FSIS is updating its regulations on the accreditation of chemistry laboratories (§ 318.21 and § 381.53), a function performed by FSIS's Office of Public Health and Science (OPHS). An erroneous street address for the Accredited Laboratory Program is being removed and the OPHS Assistant Administrator is referred to instead of a former OPHS organizational unit.

In § 320.5 (Registration) and § 381.179 (Registration), FSIS is amending paragraph (a) in both sections by changing the office name from where registration forms are obtained and also providing another option for obtaining registration forms. The office name will be changed from Compliance Programs, Regulatory Programs, to Evaluation and Enforcement Division, Office of Program Evaluation, Enforcement and Review. The other option added for obtaining an application is to call the District Office.

FSIS has determined that the notice and comment and delayed effective date requirements of the Administrative Procedure Act (5 U.S.C. 553(b) and (d)) do not apply to this rule. The amendments made by this rule reflect the Agency's current responsibilities, the organization through which it carries out those responsibilities, and technical and minor changes in the organization of the Agency's regulations and organizational terminology. Therefore, FSIS has, for good cause, found that notice and public procedure thereon are unnecessary, and it is issuing these amendments as a final rule, effective upon publication.

The changes in this rule are organizational and technical. Their adoption will not affect the costs of regulated establishments or of FSIS, except to the extent that providing the public with current information on how the Agency operates should increase the Agency's efficiency and improve the delivery of inspection services to members of the regulated industries. Therefore, FSIS has determined that this rule is not a significant regulatory action under the criteria set forth in Executive Order 12866.

For the same reasons, FSIS certifies that this rule will not have a significant economic impact on a substantial number of small entities. Accordingly, as provided in section 605 of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), sections 603 and 604 do not apply.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. No retroactive effect will be given to the rule and no administrative proceedings will be required before parties may file suit in court challenging the rule. States and local jurisdictions may not impose inconsistent requirements on federally inspected premises, facilities, or operations.

No collections of information will be affected by the adoption of this rule.

Public awareness of all segments of rulemaking and policy development is important. Consequently, in an effort to better ensure that minorities, women, and persons with disabilities are aware of this notice, FSIS will announce it and make copies of this Federal Register publication available through the FSIS Constituent Update. FSIS provides a weekly Constituent Update, which is communicated via Listserv, a free e-mail subscription service. In addition, the update is available on-line through the FSIS Web page located at http://www.fsis.usda.gov . The update is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, recalls, and any other types of information that could affect or would be of interest to our constituents/stakeholders. The constituent Listserv consists of industry, trade, and farm groups, consumer interest groups, allied health professionals, scientific professionals, and other individuals that have requested to be included. Through the Listserv and web page, FSIS is able to provide information to a much broader, more diverse audience.

For more information contact the Congressional and Public Affairs Office, at (202) 720-9113. To be added to the free e-mail subscription service (Listserv) go to the “Constituent Update” page on the FSIS Web site at http://www.fsis.usda.gov/oa/update/update.htm . Click on the “Subscribe to the Constituent Update Listserv” link, then fill out and submit the form.

The purposes of this document are:

1. To categorize those bacterial vaccines and toxoids licensed before July 1972 according to the evidence of their safety and effectiveness, thereby determining whether they may remain licensed and on the market;

2. To issue a final response to recommendations made in the Panel's report. These recommendations concern conditions relating to active components, labeling, tests required before release of product lots, product standards, or other conditions considered by the Panel to be necessary or appropriate for assuring the safety and effectiveness of the reviewed products;

3. To revise the standard for potency of Tetanus Immune Globulin in § 610.21 (21 CFR 610.21); and

4. To apply the labeling requirements in §§ 201.56 and 201.57 (21 CFR 201.56 and 201.57) to bacterial vaccines and toxoids by amending the implementation dates in § 201.59 (21 CFR 201.59).

In the Federal Register of February 13, 1973 (38 FR 4319), FDA issued procedures for the review by independent advisory review panels of the safety, effectiveness, and labeling of biological products licensed before July 1, 1972. This process was eventually codified in § 601.25 (21 CFR 601.25) (38 FR 32048 at 32052, November 20, 1973). Under the panel assignments published in the Federal Register of June 19, 1974 (39 FR 21176), FDA assigned the biological product review to one of the following groups: (1) Bacterial vaccines and bacterial antigens with “no U.S. standard of potency,” (2) bacterial vaccines and toxoids with standards of potency, (3) viral vaccines and rickettsial vaccines, (4) allergenic extracts, (5) skin test antigens, and (6) blood and blood derivatives.

Under § 601.25, FDA assigned responsibility for the initial review of each of the biological product categories to a separate independent advisory panel consisting of qualified experts to ensure objectivity of the review and public confidence in the use of these products. Each panel was charged with preparing an advisory report to the Commissioner of Food and Drugs which was to: (1) Evaluate the safety and effectiveness of the biological products for which a license had been issued, (2) review their labeling, and (3) identify the biological products that are safe, effective, and not misbranded. Each advisory panel report was also to include recommendations classifying the products reviewed into one of three categories.

• Category I designating those biological products determined by the Panel to be safe, effective, and not misbranded.

• Category II designating those biological products determined by the Panel to be unsafe, ineffective, or misbranded.

• Category III designating those biological products determined by the Panel not to fall within either Category I or Category II on the basis of the Panel's conclusion that the available data were insufficient to classify such biological products, and for which further testing was therefore required. Category III products were assigned to one of two subcategories. Category IIIA products were those that would be permitted to remain on the market pending the completion of further studies. Category IIIB products were those for which the Panel recommended license revocation on the basis of the Panel's assessment of potential risks and benefits.

In its report, the Panel could also include recommendations concerning any condition relating to active components, labeling, tests appropriate before release of products, product standards, or other conditions necessary or appropriate for a biological product's safety and effectiveness.

In accordance with § 601.25, after reviewing the conclusions and recommendations of the review panels, FDA would publish in the Federal Register a proposed order containing: (1) A statement designating the biological products reviewed into Categories I, II, IIIA, or IIIB, (2) a description of the testing necessary for Category IIIA biological products, and (3) the complete panel report. Under the proposed order, FDA would propose to revoke the licenses of those products designated into Category II and Category IIIB.

After reviewing public comments, FDA would publish a final order on the matters covered in the proposed order.

In the Federal Register of December 13, 1985 (50 FR 51002), FDA issued a proposed rule responding to the recommendations of the Panel (the December 1985 proposal). In the December 1985 proposal, FDA proposed regulatory categories (Category I, Category II, or Category IIIB as defined previously in this document) for each bacterial vaccine and toxoid under review by the Panel, and responded to other recommendations made by the Panel. The public was offered 90 days to submit comments in response to the December 1985 proposal.

The above stated definition of Category IIIA was applied at the time of the Panel's review and served as the basis for the Panel's recommendations. In the Federal Register of October 5, 1982 (47 FR 44062), FDA revised § 601.25 and codified § 601.26, which established procedures to reclassify those products in Category IIIA into either Category I or Category II based on available evidence of effectiveness. The Panel recommended that a number of biological products be placed into Category IIIA. FDA assigned the review of those products previously classified into Category IIIA to the Vaccines and Related Biological Products Advisory Committee. FDA has addressed the review and reclassification of bacterial vaccines and toxoids classified into Category IIIA through a separate administrative procedure (see the Federal Register of May 15, 2000 (65 FR 31003), and May 29, 2001 (66 FR 29148)). Therefore, FDA does not further identify or discuss in this document any bacterial vaccines and toxoids classified into Category IIIA.

FDA received four letters of comments in response to the December 1985 proposal. One letter from a licensed manufacturer of bacterial vaccine and toxoid products concerned the confidentiality of information it had submitted for the Panel's review. As provided in § 601.25(b)(2), FDA considered the extent to which the information fell within the confidentiality provisions of 18 U.S.C. 1905, 5 U.S.C. 552(b) or 21 U.S.C. 331(j) before placing the information in the public docket for the December 1985 proposal. Another comment from a member of the Panel provided an update of important scientific information related to bacterial vaccines and toxoids that had accrued since the time of the Panel's review. The letter did not comment on the December 1985 proposal nor did it contend that the newly available information should result in modification of the Panel's recommendations or FDA's proposed actions. FDA's responses to the comments contained in the remaining two letters of comment follows.

(Comment 1) One comment from a licensed manufacturer of bacterial vaccines and toxoids objected to the proposed classification into Category IIIA of several of its products for use in primary immunization.

As described previously in this document, FDA is considering those products proposed for Category IIIA in a separate rulemaking process. This final rule does not take any action regarding the further classification of those products proposed for Category IIIA, including those proposed for Category IIIA for primary immunization. All manufacturers and others in the general public have been offered additional opportunity to comment on the final categorization of specific category IIIA products in the above-noted process.

(Comment 2) In response to FDA's proposal that Pertussis Immune Globulin (Human) be placed into category IIIA because of insufficient evidence of efficacy, one comment stated that FDA should permit manufacture of Pertussis Immune Globulin (Human) for export only. The comment noted that medical practices in other countries may differ from those in the United States and that in some countries Pertussis Immune Globulin (Human) plays an important role in the augmentation of therapy with antibiotics in young, very ill infants with pertussis.

Since that time, FDA has revoked all licenses for Pertussis Immune Globulin (Human) at the requests of the individual manufacturers. The FDA Export Reform and Enhancement Act of 1996 (Public Law 104-134, as amended by Public Law 104-180) amended provisions of the Federal Food, Drug, and Cosmetic Act (the act) pertaining to the export of certain unapproved products. Section 802 of the act (21 U.S.C. 382) contains requirements for the export of products not approved in the United States. Under these provisions, products such as Pertussis Immune Globulin (Human) could be exported to other countries, if the requirements of section 802 are met.

(Comment 3) One comment concerned the generic order and wording for product labeling recommended by the Panel and which FDA proposed to adopt in its response to the Panel recommendation. The comment recommended that a labeling section concerning “Overdose” be included only when circumstances dictate. The comment stated that because all biological products are prescription products administered by health care providers, the risk of overdose should be greatly reduced.

FDA agrees that in many cases a labeling section “Overdosage” is not necessary. Section 201.56(d)(3) of the labeling regulations provides that the labeling may omit any section or subsection of the labeling format (outlined in § 201.56) if clearly inapplicable. The “Overdosage” section, provided for in § 201.57(i) of the regulations, is omitted for many bacterial vaccine and toxoid products.

(Comment 4) One letter of comment objected to several statements made by the Panel and provided in the written report but did not object to or comment on FDA's proposed responses to the Panel's recommendations.

FDA is not considering comments on the Panel's report in this rulemaking. The Panel's recommendations are not binding but represent the scientific opinions of a Panel of experts. FDA believes that the agency should not modify the statements and recommendations of the Panel as provided in its report, including through public comment. The purpose of the opportunity for comment was to allow comment on FDA's responses to the Panel's report and not on the Panel's report directly.

Category I . Licensed biological products determined to be safe and effective and not misbranded . Table 1 of this document is a list of those products proposed in December 1985 by FDA for Category I. Under the “Comments” column, FDA notes those products for which FDA's proposed category differs from that recommended by the Panel. Products for which the licenses were revoked before the December 1985 proposal are not listed but were identified in the December 1985 proposal. Products for which the licenses were revoked after the December 1985 proposal are identified in the “Comments” column. After review of the comments and finding no additional scientific evidence to alter the proposed categorizations, FDA adopts Category I as the final category for the following products.

Category II. Licensed biological products determined to be unsafe or ineffective or to be misbranded and which should not continue in interstate commerce . FDA did not propose that any products be placed in Category II and in this final rule does not categorize any products in Category II.

Category IIIB. Biological products for which available data are insufficient to classify their safety and effectiveness and should not continue in interstate commerce . Table 2 of this document is a list of those products proposed by FDA for Category IIIB. We have not listed products for which FDA revoked the licenses before the December 1985 proposal but we identified them in the proposal. Products for which FDA revoked the licenses after the December 1985 proposal are identified in the “Comments” column.

FDA has revoked the licenses of all products proposed by FDA for Category IIIB. After review of the comments and finding no additional scientific evidence to alter the proposed categorization, FDA adopts Category IIIB as the final category for the listed products.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. This rule is being promulgated without an NPRM because the limited effect on vessel traffic makes notice and comment unnecessary. Maintenance on the bridge will not begin until after the closure of Lock 22 on the Mississippi River. After that time, only commercial vessels left in the pools above Lock 22 will be able to transit through the bridge. Both the bridge and lock closure recur at the same time each year, and local vessel operators plan for the closures in advance. Prompt publication of this rule is also necessary to protect the public from safety hazards associated with conducting maintenance on the bridge.

On November 17, 2003, the Canadian National/Illinois Central Railroad Company requested a temporary change to the operation of the Illinois Central Railroad Drawbridge across the Upper Mississippi River, Mile 579.9 at Dubuque, Iowa. Canadian National/Illinois Central Railroad Company requested that 24 hours advance notice be required to open the bridge during the maintenance period. The maintenance is necessary to ensure the continued safe operation of the drawbridge. Advance notice may be given by calling the Canadian National/Illinois Central Dispatcher's office at (800) 711-3477 at any time; or Mr. Mike McDermott, office (319) 236-9238 or cell phone (319) 269-2102.

The Illinois Central Railroad Drawbridge navigation span has a vertical clearance of 19.9 feet above normal pool in the closed to navigation position. Navigation on the waterway consists primarily of commercial tows and recreational watercraft. Presently, the draw opens on signal for passage of river traffic. The Canadian National/Illinois Central Railroad Company requested the drawbridge be permitted to remain closed to navigation from 12:01 a.m., December 17, 2004, until 9 a.m., March 15, 2004 unless 24 hours advance notice is given to open the drawbridge. Winter freezing of the Upper Mississippi River coupled with the closure of Army Corps of Engineer's Lock No. 22 (Mile 301.2 UMR) until 7:30 a.m. March 15, 2004 will reduce any significant navigation demands for the drawspan opening. The Illinois Central Railroad Drawbridge, Mile 579.9, Upper Mississippi River, is located upstream from Lock 22. Performing maintenance on the bridge during the winter when the number of vessels likely to be impacted is minimal is preferred to restricting vessel traffic during the commercial navigation season.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS).

Because vessel traffic in the area of Dubuque, Iowa will be greatly reduced by winter icing of the Upper Mississippi River and the closure of Lock 22, it is expected that this rule will have minimal economic or budgetary effects on the local community.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. This temporary rule will have a negligible impact on vessel traffic. The primary users of the Upper Mississippi River in Dubuque, Iowa are commercial towboat operators. With the onset of winter conditions on the Upper Mississippi River coupled with the closure of Army Corps of Engineers' Lock No. 22 (Mile 301.2 UMR) until March 15, 2004, there will be few, if any, significant navigation demands for the drawspan opening. Vessels may still transit through the bridge with 24-hour advanced notification.

The Coast Guard certifies under 5 U.S.C. 605 (b) that this rule will not have a significant economic impact on a substantial number of small entities.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offered to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process. Any individual that qualifies or, believes he or she qualifies as a small entity and requires assistance with the provisions of this rule, may contact Mr. Roger K. Wiebusch, Bridge Administrator, Eighth Coast Guard District, Bridge Branch, at (314) 539-3900, extension 2378.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

This rule contains no new collection-of-information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not affect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not concern an environmental risk to health or risk to safety that may disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. It has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

We have analyzed this rule under Commandant Instruction M16475.1D, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2. of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph 32(e), of the Instruction, from further documentation.

We encourage you to comment on this rule. If you submit comments and related material, please include your name and address, identify the docket number for this rulemaking (COTP Los Angeles-Long Beach 01-013), indicate the specific section of this document to which each comment applies, and give the reason for each comment. Please submit all comments and related material in an unbound format, no larger than 8 1/2 by 11 inches, suitable for copying. If you would like to know they reached us, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments and material received during the comment period. We may change this rule in view of them.

On January 9, 2002, we published a temporary final rule for Port Hueneme Harbor entitled “Security Zone; Port Hueneme Harbor, Ventura County, CA” in the Federal Register (67 FR 1097) under § 165.T11-060. The effective period for this rule was from December 21, 2001, through June 15, 2002.

On June 18, 2002, we published a temporary final rule for Port Hueneme Harbor entitled “Security Zone; Port Hueneme Harbor, Ventura County, CA” in the Federal Register (67 FR 41341) under § 165.T11-060. The effective period was extended through June 15, 2003. On June 10, 2003, the Captain of the Port issued another temporary final rule extending the effective period until 11:59 p.m. PST on December 15, 2003 (68 FR 36745, June 19, 2003).

This temporary final rule further extends the effective period through June 15, 2004.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. Due to the terrorist attacks on September 11, 2001 and the warnings given by national security and intelligence officials, there is an increased risk that further subversive or terrorist activity may be launched against the United States. A heightened level of security has been established around Naval Facilities. The original TFR was urgently required to prevent possible terrorist strikes against the United States and more specifically the people, waterways, and properties in Port Hueneme Harbor and the Naval Base Ventura County. It was anticipated that we would assess the security environment at the end of the effective period to determine whether continuing security precautions were required and, if so, propose regulations responsive to existing conditions. We have determined the need for continued security regulations exists.

The Coast Guard has determined that designation of a restricted area by the Army Corps of Engineers (ACOE) under 33 CFR part 334 is a more appropriate regulation in this case. On January 13, 2003, ACOE published a notice of proposed rulemaking for Port Hueneme Harbor entitled “United States Navy Restricted Area, Naval Base Ventura County, Port Hueneme, CA” in the Federal Register (68 FR 1791) under 33 CFR 334.1127. The ACOE will utilize the extended effective period of this TFR to issue a final rule. This TFR preserves the status quo within the harbor while a permanent restricted area is implemented.

For the reasons stated in the paragraphs above under 5 U.S.C. 553(d)(3), the Coast Guard also finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register .

On September 11, 2001, terrorists launched attacks on commercial and public structures—the World Trade Center in New York and the Pentagon in Arlington, Virginia—killing large numbers of people and damaging properties of national significance. There is an increased risk that further subversive or terrorist activity may be launched against the United States based on warnings given by national security and intelligence officials. The Federal Bureau of Investigation (FBI) has issued warnings on October 11, 2001 and February 11, 2002 concerning the potential for additional terrorist attacks within the United States. In addition, the ongoing hostilities in Iraq and Afghanistan have made it prudent for important facilities and vessels to be on a higher state of alert because Osama Bin Ladin and his Al Qaeda organization, and other similar organizations, have publicly declared an ongoing intention to conduct armed attacks on U.S. interests worldwide.

These heightened security concerns, together with the catastrophic impact that a terrorist attack against a Naval Facility would have to the public interest, makes these security zones prudent on the navigable waterways of the United States. To mitigate the risk of terrorist actions, the Coast Guard has increased safety and security measures on the navigable waterways of U.S. ports and waterways as further attacks may be launched from vessels within the area of Port Hueneme Harbor and the Naval Base Ventura County.

In response to these terrorist acts, to prevent similar occurrences, and to protect the Naval Facilities at Port Hueneme Harbor and the Naval Base Ventura County, the Coast Guard has established a security zone in all waters within Port Hueneme Harbor. This security zone is necessary to prevent damage or injury to any vessel or waterfront facility, and to safeguard ports, harbors, or waters of the United States in Port Hueneme Harbor, Ventura County, CA.

As of today, the need for a security zone in Port Hueneme Harbor still exists. This temporary final rule will extend the current effective date of the current Port Hueneme security zone through June 15, 2004. This will allow the Army Corps of Engineers to utilize the extended effective period of this TFR to complete notice and comment rulemaking for permanent regulations tailored to the present and foreseeable security environment. This revision preserves the status quo within the Port Hueneme Harbor while permanent rules are finalized.

This regulation that is extending the effective period of the current security zone, prohibits all vessels from entering Port Hueneme Harbor beyond the COLREGS demarcation line set forth in subpart 80.1120 of part 80 of Title 33 of the Code of Federal Regulations without first filing a proper advance notification of arrival as required by part 160 of Title 33 of the Code of Federal Regulations as well as obtaining clearance from Commanding Officer, Naval Base Ventura County “Control 1”.

In addition to revising paragraph (c) to extend the effective period of § 165.T11-060, we have also revised paragraph (b). Specifically, in § 165.T11-060(b)(1)(ii) we replaced references to temporary notification of arrival requirements with the corresponding permanent sections in 33 CFR part 160.

Vessels or persons violating this section would be subject to the penalties set forth in 33 U.S.C. 1232 and 50 U.S.C. 192. Pursuant to 33 U.S.C. 1232, any violation of the rule described herein, would be punishable by civil penalties (not to exceed $27,500 per violation, where each day of a continuing violation would be a separate violation), criminal penalties (imprisonment up to 6 years and a maximum fine of $250,000) and in rem liability against the offending vessel. Any person violating this section by using a dangerous weapon or by engaging in conduct that causes bodily injury or fear of imminent bodily injury to any officer authorized to enforce this regulation would also face imprisonment up to 12 years. Vessels or persons violating this section would also be subject to the penalties set forth in 50 U.S.C. 192: seizure and forfeiture of the vessel to the United States, a maximum criminal fine of $10,000, and imprisonment up to 10 years.

This rule will be enforced by the Captain of the Port Los Angeles-Long Beach, who may also enlist the aid and cooperation of any Federal, State, county, municipal, and private agencies to assist in the enforcement of this rule. Commanding Officer, Naval Base Ventura County “Control 1” will control vessel traffic entering Port Hueneme Harbor. This regulation is established under the authority of 33 U.S.C. 1226 in addition to the authority contained in 50 U.S.C. 191 and 33 U.S.C. 1231.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS) because this zone will encompass a small portion of the waterway.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities because this zone will encompass a small portion of the waterway.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process. If the rule will affect your small business, organization, or government jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed under FOR FURTHER INFORMATION CONTACT for assistance in understanding this rule.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

We have analyzed this rule under Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction, from further environmental documentation because we are establishing a security zone.

A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” are available in the docket where indicated under ADDRESSES.

Pursuant to its authorities in section 7 of the Rivers and Harbors Act of 1917 (40 Stat. 266; 33 U.S.C. 1) and chapter XIX of the Army Appropriation Act of 1919 (40 Stat. 892; 33 U.S.C. 3) the Corps is amending the restricted area regulations in 33 CFR part 334 by amending § 334.1220 to enlarge the presently established naval restricted Area 1, in Hood Canal, adjacent to Naval Submarine Base Bangor, at Bangor, Washington.

This rule is issued with respect to a military function of the Defense Department and the provisions of Executive Order 12866 do not apply.

This rule has been reviewed under the Regulatory Flexibility Act (Pub. L. 96-354), which requires the preparation of a regulatory flexibility analysis for any regulation that will have a significant economic impact on a substantial number of small entities ( i.e. , small businesses and small governments). The Corps expects that the economic impact of the enlargement of this restricted area would have practically no impact on the public, no anticipated navigational hazard or interference with existing waterway traffic, and accordingly, certifies that this proposal will have no significant economic impact on small entities.

The Seattle District has prepared an Environmental Assessment (EA) for this action. The District has concluded that this action will not have a significant impact on the quality of the human environment, and preparation of an Environmental Impact Statement is not required. The EA may be reviewed at the Seattle District Office listed at the end of FOR FURTHER INFORMATION CONTACT , above.

This rule does not impose an enforceable duty among the private sector and, therefore, is not a Federal private sector mandate and is not subject to the requirements of section 202 or 205 of the Unfunded Mandates Act. The District has also found under section 203 of the Act, that small governments will not be significantly and uniquely affected by this rulemaking

Applications to NIH for grants for biomedical and behavioral research and NIH research and development contract project concepts and contract proposals are reviewed under a two-level scientific peer review system. This dual system separates the scientific assessment of proposed projects from policy decisions about scientific areas to be supported and the level of resources to be allocated, which permits a more objective and complete evaluation than would result from a single level of review. The review system is designed to provide NIH officials with the best available advice about scientific and technical merit as well as program priorities and policy considerations.

The review system consists of two sequential levels of review for each application that will be considered for funding. For most grant and cooperative agreement (hereafter referred to as grant) applications, the initial or first level review involves panels of experts established according to scientific disciplines or medical speciality areas, whose primary function is to evaluate the scientific merit of grant applications. These panels are referred to as Scientific Review Groups (SRGs), a generic term that includes both regular study sections and Special Emphasis Panels (SEPs). In some cases, SRGs in scientifically related areas are organizationally combined into Initial Review Groups (IRGs).

The second level of review of grant applications is performed by National Advisory Boards or Councils composed of both scientific and lay representatives. The recommendations made by these Boards or Councils are based not only on considerations of scientific merit as judged by the SRG but also on the relevance of a proposed project to the programs and priorities of NIH. In most cases, Councils concur with the SRG recommendations. If a Board or Council does not concur with the SRG's assessment of scientific merit, the Board or Council can defer the application for rereview. Subject to limited exceptions as described in Council operating procedures, unless an application is recommended by both the SRG and the Board or Council, no award can be made.

The first level of review of grant applications and both levels of review of contract project concepts and contract proposals are governed by the regulations codified at 42 CFR part 52h, Scientific Peer Review of Research Grant Applications and Research and Development Contract Projects.

The regulations at 42 CFR part 52h were last amended in November 1982. We are revising the regulations to incorporate changes that are necessary to update part 52h.

We are revising the regulations to: (1) Clarify the section pertaining to conflict of interest to reinforce the fact that non-Federal members of SRGs are not appointed as Special Government Employees (SGEs) and therefore are not subject to the conflict of interest statutes and regulations applicable to Federal employees; in practical terms, this means that institutional conflicts as defined for SGEs do not automatically create conflicts of interest for peer reviewers; (2) provide a more practical view of the very complex relationships that occur in the scientific community; (3) clarify the applicability of the peer review rules to the review of grant applications and contract proposals; (4) clarify the review criteria applicable to grant applications; and (5) update references, add or amend definitions as necessary, and make appropriate editorial changes.

We developed the changes to § 52h.8 “What are the review criteria for grants?” after extensive input from and discussion with the scientific community during 1996-1997 in response to a report entitled “Rating of Grant Applications” that was shared with the scientific community. The report and rating criteria were discussed at four open meetings of the Peer Review Oversight Group, whose members include representatives from the peer review community. That group made recommendations to NIH on review criteria (minutes of these meetings are posted on the NIH homepage at ( http://grants.nih.gov/grants/peer/peer.htm ). There was extensive discussion of how to include the concepts of “innovativeness” and “impact” of the research. After due consideration, the Director of NIH decided on the revised review criteria for rating unsolicited research grant applications that we published in the NIH Guide for Grants and Contracts ( NIH Guide ) on June 27, 1997. These review criteria have been well received by the research community and by those involved in the review process, who view them as beneficial to the review process.

Section 52h.8 clarifies and rearranges the previous review criteria consistent with the criteria published in the NIH Guide. The term “originality” is moved from (a) to the new (c) where it becomes “innovativeness and originality of the proposed research.” Criterion (b) is clarified from “methodology” to “approach and methodology.” Criterion (e) is clarified as “the scientific environment and reasonable availability of resources” instead of only “reasonable availability of resources.” The Scientific Review Group will assess the overall impact that the project could have on the field in light of the assessment of individual review criteria. Additionally, review criterion (f), concerning plans to include both genders, minorities, children and special populations, is added to reflect current statutes and NIH policies.

Additionally, the authority citation is amended to reflect the current authorities, and §§ 52h.2, 52h.3, 52h.5, and 52h.10 are amended to reflect the applicability of the regulations to NIH alone. In accordance with the changes in applicability, references to the Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA) and the Health Resources and Services Administration (HRSA) are deleted. Section 52h.2 is amended to include definitions for several additional terms, and minor editorial changes are made for several definitions and § 52h.6.

In the Federal Register of September 21, 2000 (65 FR 57133), NIH published a notice of proposed rulemaking (NPRM), “Scientific Peer Review of Research Grant Applications and Research and Development Contract Projects,” that provided for a 60-day public comment period. NIH received 13 responses. NIH's consideration of and responses to the comments are discussed below.

In § 52h.4(b) and (b)(4), the phrase “or upon their qualifications as authorities knowledgeable in the various disciplines and fields related to the scientific areas under review” was carried over from the § 52h.2(i) definition of peer review group to provide consistent language about the types of expertise needed to compose a peer review group.

The Office of Government Ethics suggested that NIH explain the basis for its conclusion in § 52h.4(c) that members of its peer review groups are not Special Government Employees. A discussion of the statutory and other bases for that conclusion follows.

Pursuant to the Public Health Service (PHS) Act, as amended by the Health Research Extension Act of 1985, the Secretary of Health and Human Services (Secretary), acting through the Director of NIH, shall by regulation require appropriate technical and scientific peer review of applications for grants, cooperative agreements and contracts for biomedical and behavioral research. Section 402(b)(6), PHS Act, as amended, provides that the Director of NIH can establish peer review groups without regard to Title 5 U.S.C. It is further stipulated (section 492, PHS Act, as amended (42 U.S.C. 289a)) that such review is to be conducted in a manner consistent with the system for technical and scientific peer review applicable on November 20, 1985. On that date, and for many years prior, peer reviewers were not appointed as or considered to be Federal employees because this peer review was supported through an extramural award mechanism. As directed by the statute, this method of conducting peer review has continued since November 20, 1985.

In fact, the NIH process for peer review has varied little since its inception approximately 50 years ago. Members of the scientific research community have been selected for service on peer review groups, either as members for a specified period of time or on an ad hoc basis from time to time, on a per diem basis but not under the Civil Service ( e.g. , not as Special Government Employees). There are no appointment papers prepared. These individuals are identified by the Federal employees who oversee the peer review process, the Scientific Review Administrators (SRAs). The SRAs identify potential peer review group members primarily through their knowledge of researchers in the various applicable scientific fields. The make-up of these peer review groups may be up to one-fourth Federal employees (§ 52h.4(c)), such as NIH intramural scientists, but in practice, historically approximately only 1 percent of peer reviewers are Federal employees. Other than the Federal employee reviewers (who cannot be paid any amount in excess of their salaries), peer reviewers are reimbursed through an extramural award mechanism for their services. The reimbursement includes a payment for actual expenses (transportation, room, and board) plus a modest consultant fee for the period of time they are involved in the review of applications at meetings, commonly held in the Bethesda, Maryland area.

The conduct of meetings is directed by the chairperson, although the SRA is the Designated Federal Official who must be present during the review of applications to ensure that the reviews are conducted according to regulations, which includes adherence to established review criteria. Although there is no supervisory relationship between the SRA and the peer reviewers, general guidance on the conduct of meetings has been developed over time through an agreement between the Federal employee overseeing the process and the peer reviewers.

One commenter noted that § 52h.5 greatly improves upon current language regarding how these rules apply to non-Federal employees serving on peer review panels, as distinct from other individuals to whom separate Federal regulations apply. Section 52h.5(a) was further clarified to state that the conflict of interest section applies only to conflict of interest involving members of peer review groups. Since it applies to all members, the phrase “who are not Federal employees” was deleted.

One commenter noted that the distinction in the proposed rule between real and apparent conflicts of interest in § 52h.5(b) is artificial and misleading because a real conflict of interest is limited to financial interests and an apparent conflict of interest would encompass all other personal interests that might bias the reviewer. The commenter proposed a single definition of conflict of interest based on the prospect of a personal advantage to the reviewer, whether financial or nonfinancial. A conflict would exist if that personal advantage is strong enough to pose a realistic probability that the reviewer will not perform an unbiased review. As we understand the comment, a distinction would still be made between a conflict involving a direct financial benefit, from which an automatic recusal from the review would result, and other personal interests, which would result in a recusal only if the Scientific Review Administrator and the reviewers so determined.

In response to this comment, definitions of a real conflict of interest and the appearance of a conflict of interest are added to the definitions section of the regulation. However, the substance of the definitions is essentially the same as the meaning given those terms, respectively, in § 52h.5(b)(1) and § 52h.5(b)(2) of the proposed rule. The definition of a real conflict of interest makes it clear that a real conflict of interest exists when certain financial interests are present, when the reviewer acknowledges the presence of an interest that would likely bias his/her review, or when the official managing the review determines the reviewer has such an interest. Thus the definition of a real conflict of interest is not limited to financial interests. We have further highlighted the definition of other (nonfinancial) conflicts of interest by adding subpart (3) to the definition of real conflict of interest (§ 52h.2(q)); this also clarifies our expectation about the professionalism of each reviewer to identify real or apparent conflicts of interest known to the reviewer, as suggested by one comment. The definition of the appearance of a conflict of interest adopts a different test, the perception of a reasonable person regarding the reviewer's impartiality. This would encompass (1) a financial interest that does not meet the threshold for a real conflict of interest and (2) other personal interests that the official managing the review determines are not likely to bias the reviewer's evaluation of the application or proposal but would cause a reasonable person to question the reviewer's impartiality.

The distinction between a real conflict of interest and an appearance of a conflict of interest has important consequences. A reviewer with a real conflict of interest cannot participate in the review unless the Director of NIH determines that (1) the reviewer's interest arises from his/her ties to a component of a large or multicomponent organization that is independent of the component seeking the funding, (2) the Director makes the determination for a contract proposal that the reviewer is the only person available with the requisite expertise and that expertise is essential to ensure a competent and fair review, or (3) the official managing the review determines that the conflict can be obviated by having another review group review the application or proposal. If it is determined that there is an appearance of a conflict of interest, the reviewer must be recused unless the Director determines that it would be difficult or impractical to carry out the review without the reviewer and the integrity of the review process would not be impaired.

It is expected that examples of real and apparent conflicts of interest will be made available to review officials and reviewers through guidance documents noted in § 52h.5(g), but every instance of such conflicts cannot be anticipated. In addition, the application of the regulations will be reviewed periodically with a view toward any changes that would lessen administrative burdens without compromising the integrity of the review process.

One commenter strongly supported the proposed new regulations, including § 52h.5(b)(1)(i), because they broaden the number of scientists who can serve as potential reviewers of a specific application and allow the Director to determine that components of a multicomponent organization are sufficiently independent so that an employee of one component can review an application/proposal from another component without a real or apparent conflict of interest. The commenter requested that his organization be recognized as analogous to separate campuses within the same university system; this request will be evaluated separately. Section 52h.5(b)(1) is retained and clarified so that it applies, provided that the reviewer has no multicampus responsibilities at the institution that would significantly affect the other component.

There were several comments regarding § 52h.5(b)(1)(ii), which sets $5,000 for non-salaried direct financial benefit as the threshold for financial conflict of interest. One commenter stated that this is an improvement upon the current regulations by stipulating a threshold limit for honoraria received by a reviewer from an institution submitting a grant or proposal; however, it should be the same as the $10,000 threshold in 42 CFR 50.603. Another commenter stated that any association with monetary gain within the previous 12 months or within future 12 months could lead to the appearance of conflict, and that the amount proposed is immaterial. Another commenter asked whether the amount would be periodically adjusted for inflation.

We agree to setting the threshold at $10,000 (the same threshold as in 42 CFR 50.603), and agree that the amount may be adjusted periodically for inflation. Adjustments may be made by the Director, NIH, after public notice and provision for public comment. Furthermore, the definition of “real conflict of interest” in 52h.2(q)(2) has been clarified to include stock holdings. Consequently, the $10,000 threshold is a conservative one in that (1) it includes all sources of financial benefit, such as honoraria, fees and stock holdings, and (2) it includes both currently held assets as well as honoraria and other financial benefits accruing over a 12-month period. In all, these provisions are intended to allow for routine sharing and exchange of scientific information as a result of invitations to speak at seminars, scientific consultations, and similar events that would not automatically be considered a conflict of interest for the reviewer. At the same time, it would relieve excessive administrative burdens for the potential reviewer and NIH staff for reporting low levels of activity by a reviewer. If there was any concern, it could be treated as an apparent conflict of interest.

We received several comments regarding proposed § 52h.5(b)(1) that the definition of conflict of interest that involved attributing real conflicts of interest of close relatives or professional associates to the reviewer was too broad. It was noted that the reviewer may not reasonably be expected to know all of the financial or nonfinancial interests that a close relative or professional associate has with an organization or other individuals and would not normally ask them about all of their financial or nonfinancial interests. If the reviewer does not know about a particular interest of the professional associate, then it is not clear how this lack of knowledge could bias the reviewer's evaluation of an application or proposal.

We accepted the comments. Accordingly, we modified the new definitions of real and apparent conflict of interest in § 52h.2 to state that the financial or other interests are “known to the reviewer.”

Two commenters objected to § 52h.5(b)(3), which provides that when a peer review group meets regularly, it is assumed that a relationship among individual members of the group exists that requires review of a member's application or proposal by a different qualified review group. The commenters suggested that this provision is too restrictive, implies that review groups are biased toward one of their own and cannot be objective, disadvantages members, and will cause potential reviewers to refuse service on standing peer review groups.

Such concerns and perceptions are long-standing. Particularly pervasive has been the assumption that members are disadvantaged by the practice of having their applications reviewed by a different review group, a practice that the NIH has followed for many years. To the contrary, all available data indicate that this assumption is not accurate. The Center for Scientific Review, NIH, has published the available data on this issue on its Web site. This information can be accessed at http://www.csr.nih.gov/reviewmems.htm. Because the requirement of § 52h.5(b)(3) corrects a perceived conflict of interest without any disadvantage to the reviewer-applicant, we have made no change in response to this comment.

We provide the following as public information.

Executive Order 12866, Regulatory Planning and Review, requires that regulatory actions reflect consideration of the costs and benefits they generate, and that they meet certain standards, such as avoiding the imposition of unnecessary burdens on the affected public. If a regulatory action is deemed to fall within the scope of the definition of the term “significant regulatory action” contained in section 3(f) of the Order, prepublication review by the Office of Management and Budget's (OMB) Office of Information and Regulatory Affairs (OIRA) is necessary. OIRA reviewed this rule and deemed it significant. Therefore, OMB reviewed this rule prior to publication.

The Regulatory Flexibility Act (5 U.S.C. chapter 6) requires that agencies analyze regulatory actions to determine whether they will create a significant impact on a substantial number of small entities. The Secretary certifies that this rule will not have any such impact.

Executive Order 13132, Federalism, requires that Federal agencies consult with State and local government officials in the development of regulatory policies with federalism implications. We reviewed the rule as required under the Order and determined that it does not have any federalism implications. The Secretary certifies that this rule will not have an effect on the States or on the distribution of power and responsibilities among the various levels of government.

This rule does not contain any information collection requirements that are subject to review by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35).

Table of Contents I. Background II. Petitions For Reconsideration III. Final Rule IV. Regulatory Analyses and Notices I. Background

FMVSS No. 205 specifies performance requirements for glazing installed in motor vehicles. It also specifies the vehicle locations in which the various types of glazing may be installed. On July 25, 2003, NHTSA issued a final rule (July 25 final rule) updating FMVSS No. 205 so that it incorporates by reference the 1996 version of the American Standards Institute (ANSI) standard on motor vehicle glazing. Prior to the July 25 final rule, FMVSS No. 205 referenced the 1977 version of ANSI Standard Z26.1, “Safety Code for Safety Glazing Materials for Glazing Motor Vehicles Operating on Land Highways,” and the 1980 supplement to that standard. 2 Since 1977, the ANSI Standard Z26.1 has been periodically revised, however the newer versions of the standard were not incorporated into the FMVSS No. 205.

The July 25 final rule has simplified and amended the glazing performance requirements. Amendments to the standard over the past 20 years have resulted in a patchwork of requirements that must be read alongside the industry standard in order to gain a comprehensive understanding of the overall requirements of FMVSS No. 205. By incorporating by reference the 1996 version of the ANSI standard, the agency is now able to delete most of the existing text in FMVSS No. 205.

In addition to incorporating the 1996 ANSI standard, the final rule addressed several issues not covered by that standard. For example, the final rule limited the size of the shade band located at the top of the windshield and clarified the meaning of the term “the most difficult part or pattern” for the fracture test in the 1996 ANSI standard. The final rule also made minor conforming amendments to the standard on low speed vehicles. The July 25 final rule was to become effective on January 22, 2004. 3 For further details on the subject final rule, please see 68 FR 43964 (July 25, 2003).

In response to the July 25 final rule, the agency received six petitions for reconsideration. Petitions were submitted by DaimlerChrysler, General Motors (GM), Alliance for Automobile Manufacturers (Alliance), PPG Industries (PPG), Pilkington North America (PNA), and Visteon. Petitioners have asked the agency to reconsider the following issues.

DaimlerChrysler, GM, PPG, PNA, and Visteon have asked that the agency reconsider its decision to change the visibility up-angle from 5 degrees to 7 degrees. Specifically, petitioners note that NHTSA has not demonstrated a safety need for this technical modification, and that the up-angle change was not discussed in the NPRM. DaimlerChrysler estimates that 25% of vehicles currently in production would not comply with the 7-degree up-angle requirement. Accordingly, petitioners contend that the change in the up-angle would place a significant burden on the manufacturers. Additionally, Visteon commented that the change in up-angle would necessitate a costly redesign of aftermarket replacement glazing.

GM, DaimlerChrysler, PPG and PNA have asked the agency to clarify or reconsider the meaning of the phrase “most difficult part or pattern” in the context of the fracture test provisions of ANSI Z26. Specifically, petitioners contend that the preamble to the final rule, S5.2 of the regulatory text, and NHTSA's previous interpretations on the issue, are inconsistent as to the use of the phrase.

DaimlerChrysler and PPG have also asked the agency to formally define the term “Day Light Opening” and rescind a previously issued interpretation letter on the subject.

DaimlerChrysler, GM, PPG, PNA and Alliance have asked the agency to reconsider its position with respect to soldered terminals. Specifically, petitioners ask that compliance fracture testing be conducted without soldered terminals being attached to glazing. According to petitioners, a prior interpretation letter on the issue, coupled with the language in the final rule created confusion as to whether fracture testing would be conducted with the terminals attached. Petitioners ask that NHTSA clarify both the new testing procedure and also a distinction between conductors and terminals.

Petitioners, including PNA, GM, DaimlerChrysler, PPG and Visteon, have asked the agency to delay the effective date of the updated FMVSS No. 205 by up to 3 years. In support of their request, DaimlerChrysler argued that glazing manufacturers would need to perform extensive testing to demonstrate compliance with the updated requirements of FMVSS No. 205. Further, some glazing manufacturers might need to add additional equipment in order to perform the necessary testing.

Because NHTSA would not be able to respond to the petitions prior the January 22, 2004 effective date, petitioners requested that NHTSA extend the compliance deadline to a date after NHTSA completes the pending rulemaking.

DaimlerChrysler, PNA, GM and PPG have asked that the agency also consider permitting compliance with the old requirements of FMVSS No. 205 for the manufacture of aftermarket replacement glazing. According to the petitioners, it would not be feasible to redesign replacement glazing such that it would meet the updated requirements of FMVSS No. 205. Similarly, Visteon commented that the final rule necessitates a redesign of aftermarket glazing that may be time-consuming because the necessary vehicle data is not readily available to glazing manufacturers.

The agency has set a January 22, 2004, effective date for the July 25 final rule. The petitions filed by DaimlerChrysler, GM, Alliance, PPG, PNA, and Visteon have asked the agency to reconsider several aspects of that rulemaking. NHTSA is currently considering all six petitions. Unfortunately, NHTSA's consideration of the petitions has not yet concluded. The effective date set by our July 25 final rule and subsequent correction (January 22, 2004) is now a month away.

Given the imminence of the January 22, 2004, effective date, the agency has determined that it is appropriate to first partially respond to petitions concerning the effective date of the July 25 final rule. Accordingly, the agency is delaying the effective date of the July 25 final rule until September 1, 2004, after which the manufacturers will be required to meet the new requirements of FMVSS No. 205. Other issues raised in the petitions for reconsideration will be addressed by the agency in a separate document.

The agency believes that a partial response to the petitions for reconsideration is necessary to insure that glazing and automobile manufacturers do not face substantial economic hardship associated with certain new requirements of the amended FMVSS No. 205. As discussed in the petitions, the updated requirements of FMVSS No. 205 may necessitate extensive testing and retooling by glazing manufacturers. Given the number of issues raised in these petitions, NHTSA has determined that six months was an inadequate period of time to meet the new requirements. The agency also notes that extending the effective date to September 1, 2004, would permit vehicle manufacturers to avoid mid-model year product changes that would otherwise result from the July 25 final rule, coming into effect on January 22, 2004.

NHTSA expects that all other issues raised in the petitions will be fully addressed prior to the new, September 1, 2004, effective date. In the event, however, that these issues have not been resolved, all affected manufacturers will be required to meet the new requirements. Effective dates of agency final rules are not stayed due to outstanding petitions for reconsideration of those rules.

Executive Order 12866, “Regulatory Planning and Review” (58 FR 51735, October 4, 1993), provides for making determinations whether a regulatory action is “significant” and therefore subject to Office of Management and Budget (OMB) review and to the requirements of the Executive Order. The Order defines a “significant regulatory action” as one that is likely to result in a rule that may:

(1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or Tribal governments or communities;

(2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;

(3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or

(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

This rulemaking document was not reviewed under Executive Order 12866. It is not significant within the meaning of the DOT Regulatory Policies and Procedures. It does not impose any burden on manufacturers and extends the compliance date for existing regulatory requirements for an additional seven and a half months. The agency believes that this impact is so minimal as to not warrant the preparation of a full regulatory evaluation.

We have not conducted an evaluation of the impacts of this final rule under the National Environmental Policy Act. This rulemaking action extends the date by which the manufacturers must comply with the newly upgraded requirements of FMVSS No. 205. This rulemaking does not impose any change that would have any environmental impacts. Accordingly, no environmental assessment is required.

Pursuant to the Regulatory Flexibility Act, we have considered the impacts of this rulemaking action will have on small entities (5 U.S.C. 601 et seq. ). I certify that this rulemaking action will not have a significant economic impact upon a substantial number of small entities within the context of the Regulatory Flexibility Act.

The following is our statement providing the factual basis for the certification (5 U.S.C. 605(b)). The final rule affects manufacturers of motor vehicles and motor vehicle glazing. According to the size standards of the Small Business Association (at 13 CFR part 121.601), manufacturers of glazing are considered manufacturers of “Motor Vehicle Parts and Accessories” (SIC Code 3714). The size standard for SIC Code 3714 is 750 employees or fewer. The size standard for manufacturers of “Motor Vehicles and Passenger Car Bodies” (SIC Code 3711) is 1,000 employees or fewer. This Final Rule will not have any significant economic impact on a small business in these industries because it makes no significant substantive change to the requirements specified in FMVSS No. 205. Instead, this rulemaking delays the effective date of the previously published final rule by seven and a half months. Small organizations and governmental jurisdictions that purchase glazing will not be significantly affected because this rulemaking will not cause price increases. Accordingly, we have not prepared a Regulatory Flexibility Analysis.

E.O. 13132 requires NHTSA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications” to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” Under E.O. 13132, NHTSA may not issue a regulation that has federalism implication, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, or NHTSA consults with State and local officials early in the process of developing the proposed regulation.

This final rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government as specified in E.O. 13132. Thus, the requirements of section 6 of the Executive Order do not apply to this rule.

The Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires agencies to prepare a written assessment of the costs, benefits and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local or tribal governments, in the aggregate, or by the private sector, of more than $100 million annually. This action, which extends the compliance date by which the manufacturers must meet the upgraded requirements of FMVSS No. 205, will not result in additional expenditures by state, local or tribal governments or by any members of the private sector. Therefore, the agency has not prepared an economic assessment pursuant to the Unfunded Mandates Reform Act.

There are no information collection requirements in this rule.

The Department of Transportation assigns a regulation identifier number (RIN) to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. You may use the RIN contained in the heading at the beginning of this document to find this action in the Unified Agenda.

Executive Order 12866 requires each agency to write all rules in plain language. Application of the principles of plain language includes consideration of the following questions:

• Have we organized the material to suit the public's needs?

• Are the requirements in the rule clearly stated?

• Does the rule contain technical language or jargon that is not clear?

• Would a different format (grouping and order of sections, use of headings, paragraphing) make the rule easier to understand?

• Would more (but shorter) sections be better?

• Could we improve clarity by adding tables, lists, or diagrams?

• What else could we do to make the rule easier to understand?

If you have any responses to these questions, please forward them to George Feygin, Office of Chief Counsel, National Highway Traffic Safety Administration, 400 Seventh Street, SW., Washington, DC 20590.

Under the National Technology and Transfer and Advancement Act of 1995 (NTTAA) (Pub. L. 104-113), “all Federal agencies and departments shall use technical standards that are developed or adopted by voluntary consensus standards bodies, using such technical standards as a means to carry out policy objectives or activities determined by the agencies and departments.”

Certain technical standards developed by the American National Standards Institute (ANSI) and Society of Automotive Engineers (SAE) have been considered and incorporated by reference in the final rule published on July 25, 2003, which upgraded the requirements of FMVSS No. 205. This final rule extends the effective date of that final rule to September 1, 2004.

Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc. ). You may review DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visit http://dms.dot.gov.