The boll weevil, Anthonomus grandis, is a very destructive pest of cotton. This pest can cause serious economic losses by lowering the yield and quality of cotton crops. All portions of the plant may be affected, but the greatest damage occurs to the fruiting structures such as the flower buds, blooms, and bolls. This damage reduces the quality and quantity of the harvested lint or seed. Heavy infestations can result in complete loss of the crop.

Cotton production is an important element of the U.S. agricultural economy. It is the fourth most valuable crop in the United States after corn, soybeans, and wheat, with cotton production in 2003 valued at $5.5 billion, and cottonseed production at $779 million. Cotton and cotton products exported by the United States generated $5.2 billion. The boll weevil is the principal pest of this major industry, having caused losses to the nation's economy estimated at $22 billion since its introduction into the United States. Boll weevil eradication efforts have provided stability for the U.S. cotton industry and strengthened its ability to compete on the world market.

The current boll weevil eradication program is a cooperative Federal, State, and industry effort that has helped to reduce cotton losses to the boll weevil in recent years. A number of formerly infested States or portions of States are now free of this pest. Growers have benefited from significantly lower production costs and higher yields. Without effective quarantine measures, however, these higher yields would not be realized. It is also possible that, because of reinfestation, losses will again begin to mount in areas in which the boll weevil had been previously eradicated.

Because the boll weevil is a migratory pest, it is necessary for States to cooperate within regions to ensure the success of control programs. These control programs have been voluntary in the past and as a result we are very close to eradicating this pest. Although some individual growers have successfully controlled boll weevils in their fields, neighboring areas often contribute to reinfestations. The boll weevil's movement is largely dependent on wind direction and speed, but it has been known to travel up to 169 miles, often causing reinfestations across State lines.

Officials of the Animal and Plant Health Inspection Service (APHIS), cotton grower foundations, and affected States have conducted successful eradication programs over the years, moving sequentially across the infested areas. This has been achieved in the context of zones within States that have agreed to engage in eradication activities and place restrictions on the movement of certain articles from infested suppressive areas to prevent the spread of the boll weevil throughout cotton-producing States. We believe that Federal regulations are necessary to restrict the interstate movement of certain articles from areas which may become generally infested in the future and from current suppressive areas to help prevent the artificial spread of the boll weevil to noninfested areas. This is to encourage all cotton producers to remain diligent in their participation of eradication activities.

We are proposing to amend the domestic quarantine notices in 7 CFR part 301 by adding a new subpart, “Boll Weevil” (§§ 301.54 through 301.54-9, referred to below as the regulations). The regulations would provide for the designation of regulated areas, both generally infested and suppressive areas, within cotton-producing States because of the boll weevil. The regulations would restrict the interstate movement of regulated articles within regulated areas and from regulated areas into or through nonregulated areas in commercial cotton producing States. These proposed provisions are described in detail below.

In § 301.54, paragraph (a) would prohibit the interstate movement of regulated articles from any regulated area into or through any commercial cotton-producing area except in accordance with the regulations. This paragraph would also contain a footnote explaining that any properly identified inspector is authorized, upon probable cause, to stop and inspect persons and means of conveyance moving in interstate commerce and to hold, seize, quarantine, treat, apply other remedial measures to, destroy, or otherwise dispose of regulated articles as provided in section 414 of the Plant Protection Act (7 U.S.C. 7714, 7731). Paragraph (b) of this section would contain a list of States designated as commercial cotton-producing areas. These States are Alabama, Arizona, Arkansas, California, Florida, Georgia, Kansas, Kentucky, Louisiana, Maryland, Mississippi, Missouri, New Mexico, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, and Virginia.

Section 301.54-1 would contain definitions of the following terms: Administrator, Animal and Plant Health Inspection Service (APHIS), boll weevil, certificate, compliance agreement, cotton, cotton lint, cotton products, departmental permit, generally infested area, gin motes, gin trash, gin waste, infestation, inspector, interstate, limited permit, linters, moved (move, movement), oil mill waste, person, Plant Protection and Quarantine (PPQ), regulated area, regulated article, seed cotton, State, suppressive area, and used cotton equipment. These terms and their proposed definitions are set out in the proposed regulatory text at the end of this document.

Certain articles present a risk of spreading the boll weevil if they are moved from regulated areas without restrictions. We call these articles regulated articles, and would impose restrictions on their movement because the boll weevil can survive in these materials if present and could possibly be transported to noninfested areas. Paragraphs (a) through (f) of § 301.54-2 list the following as regulated articles:

• The boll weevil, in any living stage of development;

• Cotton, including wild cotton and ornamental cotton, but excluding commercial bales and cottonseed;

• Seed cotton;

• Gin trash;

• Used cotton harvesting or processing equipment; and

• Any other product, article, or means of conveyance when an inspector determines that it presents a risk of spreading the boll weevil and the person in possession of the product, article, or means of conveyance has been notified in writing that it is subject to the restrictions in the regulations.

The last item listed above, which provides for the designation of “any other product, article, or means of conveyance” as a regulated article, is intended to address the risks presented by, for example, a truck that may have inadvertently picked up plant material or adult boll weevils while driving through fields, thus enabling an inspector to designate that truck as a regulated article in order to ensure that any necessary risk-mitigating measures are carried out.

Paragraph (a) of § 301.54-3 would provide the criteria for the inclusion of States, or portions of States, in the list of regulated areas. Under these criteria, any State or portion of a State in which the boll weevil is found by an inspector, in which the Administrator has reason to believe that the boll weevil is present, or when the Administrator considers it necessary due to the area's inseparability for quarantine enforcement purposes from localities in which the boll weevil has been found, will be listed as a regulated area. These criteria also provide that an area will be designated as a regulated area when the Administrator determines that minimum pest surveillance and control activities are not maintained (see following paragraph for a discussion about these activities). As noted previously, eradication efforts are underway in some States or portions of States. Thus, this paragraph would also provide that the Administrator may designate a part of a regulated area as a suppressive area after determining that eradication of infestation is being undertaken as an objective in that part of the regulated area; any part of a regulated area that is not designated as a suppressive area will be designated as a generally infested area.

We are proposing that each cotton-producing State, or legally defined zone within a State, would be designated as a regulated area when growers fail to maintain minimum pest surveillance and control activities to prevent reinfestation of that area as well as surrounding areas by the boll weevil. These activities would consist of the annual installation and monitoring of boll weevil pheromone traps, and the application of effective control measures if boll weevils are detected. APHIS would work with entomological experts to determine appropriate minimum trapping densities in each particular area; trapping densities would be based on an area's proximity to existing infestations and susceptibility to reinfestation. Effective control measures would involve the demonstrated ability to apply in a timely manner, by aircraft or ground equipment, materials that have proven effective in eradicating the boll weevil. Such applications would have to be made within 48 hours of detecting a reinfestation. Failure by cotton growers within a State or zone where boll weevil is not known to be present to maintain the prescribed minimum standards of detection and control would result in the area being listed as a regulated area. We invite comment on our proposed requirements for minimum pest surveillance and control activities.

Paragraph (a) of § 301.54-3 would also provide that we will designate less than an entire State as a regulated area only if we determine that the State has adopted and is enforcing restrictions on the intrastate movement of regulated articles that are equivalent to those imposed on the interstate movement of regulated articles and that the designation of less than the entire State as a regulated area will prevent the interstate spread of the boll weevil. In practice, the latter determination—that the designation of less than an entire State will prevent the interstate spread of the boll weevil—would be based, at least in part, on our finding that infestations are confined to the regulated areas as a result of natural breaks between infested areas and noninfested areas, known as zones, and would eliminate the need for designating an entire State as a regulated area. APHIS would adopt existing buffer zones that have been established under the States' current eradication programs.

Paragraph (b) of § 301.54-3 would provide that we may temporarily designate any nonregulated area in a State as a regulated area when we determine that the nonregulated area meets the criteria for designation as a regulated area described in § 301.54-3(a). In such cases, we will give the owner or person in possession of the nonregulated area a copy of the regulations along with written notice of the area's temporary designation as a regulated area, after which time the interstate movement of any regulated article from the area will be subject to the regulations. This provision is necessary to prevent the spread of the boll weevil during the time between the detection of the pest and the time a document designating the area as a regulated area can be made effective and published in the Federal Register . In the event that an area's designation as a temporary regulated area is terminated, we will provide written notice of that termination to the owner or person in possession of the area as soon as is practicable.

Paragraph (c) lists the proposed regulated areas. These areas, as noted previously, would be divided into generally infested (areas that do not operate under an area-wide, APHIS-endorsed control program) and suppressive areas (areas engaged in an area-wide eradication program supported by APHIS). The proposed regulated areas, all of which are designated as suppressive areas, are listed in the rule portion of this document and include all or portions of the States of Arkansas, Louisiana, Mississippi, Missouri, New Mexico, Oklahoma, Tennessee, and Texas. The list of regulated areas was derived from information  1 provided to APHIS by State regulatory officials and cotton foundation program directors indicating evidence of boll weevil in the areas.

This section would require most regulated articles moving interstate from regulated areas to be accompanied by a certificate or a limited permit if moved into commercial cotton-producing areas. Specifically, paragraph (a) of proposed § 301.54-4 would provide that a certificate or limited permit issued and attached in accordance with §§ 301.54-5 and 301.54-8 would have to accompany regulated articles moving interstate:

• From any regulated area into or through any nonregulated area that is located in a commercial cotton-producing area listed in § 301.54(b);

• From any generally infested area into or through any suppressive area;  2 or

• Between any noncontiguous suppressive areas; or

• Between contiguous suppressive areas when it is determined by the inspector that the regulated articles present a hazard of the spread of the boll weevil and the person in possession thereof has been so notified.

Under paragraph (b) of proposed § 301.54-4, a certificate or limited permit would not be required for the movement of regulated articles into areas that are not commercial cotton-producing areas. Given the host specificity of the boll weevil, there would be little, if any, risk associated with the movement of regulated articles into areas that are not commercial cotton-producing areas due to the lack of host material for the pest.

Under paragraph (c) of proposed § 301.54-4, articles that are moved into the regulated area from outside the regulated area and that are accompanied by a waybill that indicates the point of origin may be moved interstate from the regulated area to commercial cotton-producing areas without a certificate or limited permit, provided certain conditions are met. The articles would have to be moved in an enclosed vehicle or be completely enclosed by a covering adequate to prevent access by the boll weevil. The regulated articles would also have to be moved through the regulated area without stopping (except for refueling, rest stops, emergency repairs, and for traffic conditions such as traffic lights and stop signs), and the regulated articles could not be opened, unpacked, or unloaded in the regulated area.

Finally, paragraph (d) of proposed § 301.54-4 would provide that APHIS or the U.S. Department of Agriculture (the Department) may move regulated articles interstate without a certificate or limited permit if the articles are moved for experimental or scientific purposes. However, the articles would have to be moved in accordance with a departmental permit issued by the Administrator, under conditions specified on the permit to prevent the spread of the boll weevil, and with a tag or label bearing the number of the departmental permit attached to the regulated article or to the outside of its container.

Under Federal domestic plant quarantine programs, there is a difference between the use of certificates and limited permits. Certificates are issued for regulated articles when an inspector finds that, because of certain conditions (e.g., the article is free of boll weevil), there is no pest risk before movement. Regulated articles accompanied by a certificate may be moved interstate without further restrictions. Limited permits are issued for regulated articles when an inspector finds that, because of a possible pest risk, the articles may be safely moved interstate only subject to further restrictions, such as movement to limited areas and movement for limited purposes. Section 301.54-5 would explain the conditions for issuing a certificate or limited permit.

Specifically, § 301.54-5(a) would provide that a certificate may be issued by an inspector for the interstate movement of a regulated article if the inspector determines that the article: (1) Is free of the boll weevil, has been treated under the direction of an inspector in accordance with the Plant Protection and Quarantine (PPQ) Treatment Manual, or comes from a premises of origin that is free of the boll weevil; (2) will be moved through the regulated area in an enclosed vehicle or will be completely covered to prevent access by the boll weevil; (3) will be moved in compliance with any additional remedial conditions deemed necessary to prevent the spread of the boll weevil under section 414 of the Plant Protection Act (7 U.S.C. 7714); and (4) is eligible for unrestricted movement under all other Federal domestic plant quarantines and regulations applicable to that article.

We have included a footnote that provides an address for securing the addresses and telephone numbers of the local Plant Protection and Quarantine (PPQ) offices at which services of inspectors may be requested. We have also included a footnote that explains that the Secretary of Agriculture may, under the Plant Protection Act, take remedial actions to hold, seize, quarantine, treat, destroy, apply other remedial measures to, or otherwise dispose of articles that he or she has reason to believe are a plant pest or are infested with a plant pest.

Paragraph (b) of § 301.54-5 would provide for the issuance of a limited permit (rather than a certificate) by an inspector for interstate movement of a regulated article if the inspector determines that the article is to be moved interstate to a specified destination for specified handling, utilization, or processing, and that the movement will not result in the spread of the boll weevil because life stages of the boll weevil will be destroyed by the specified handling, utilization, or processing. A limited permit will only be issued if the regulated article: (1) Will be moved in an enclosed vehicle or completely covered to prevent access by, and escape of, the boll weevil; (2) will be moved in compliance with any additional remedial conditions imposed by the Administrator under sections 414 of the Plant Protection Act (7 U.S.C. 7714) to prevent the spread of the boll weevil; and (3) if the regulated article is eligible for interstate movement under all other Federal domestic plant quarantines and regulations applicable to the regulated article.

Paragraph (c) of § 301.54-5 would provide that any person who has entered into and is operating under a compliance agreement may issue a certificate or limited permit for the interstate movement of a regulated article after determining that the article is otherwise eligible for a certificate or limited permit under § 301.54-5(a) or (b), respectively.

Also, § 301.54-5(d) would contain provisions for the withdrawal of a certificate or limited permit by an inspector if the inspector determines that the holder of the certificate or limited permit has not complied with conditions for the use of the document. This paragraph would also contain provisions for notifying the holder of the reasons for the withdrawal and for holding a hearing if there is any conflict concerning any material fact in the event that the person wishes to appeal the cancellation.

Section 301.54-6 would provide for the use of and cancellation of compliance agreements. Compliance agreements are provided for the convenience of persons who are involved in the growing, handling, or moving of regulated articles from regulated areas. A person may enter into a compliance agreement when an inspector has determined that the person requesting the compliance agreement has been made aware of the requirements of the regulations and the person has agreed to comply with the requirements of the regulations and the provisions of the compliance agreement. This section contains a footnote that explains where compliance agreement forms may be obtained.

Section 301.54-6 would also provide that an inspector may cancel the compliance agreement upon finding that a person who has entered into the agreement has failed to comply with any of the provisions of the regulations. The inspector will notify the holder of the compliance agreement of the reasons for cancellation and offer an opportunity for a hearing to resolve any conflicts of material fact in the event that the person wishes to appeal the cancellation.

Section 301.54-7 would provide that any person (other than a person authorized to issue certificates or limited permits under § 301.54-5(c)) who desires a certificate or limited permit to move regulated articles interstate must request, at least 48 hours before the desired movement, that an inspector issue a certificate or limited permit. The regulated articles would have to be assembled in a place and manner directed by the inspector.

Section 301.54-8 would require the certificate or limited permit issued for movement of the regulated article to be attached, during the interstate movement, to the regulated article, or to a container carrying the regulated article, or to the consignee's copy of the accompanying waybill. Further, the section would require that the carrier or the carrier's representative furnish the certificate or limited permit to the consignee listed on the certificate or limited permit upon arrival at the location provided on the certificate or limited permit.

Section 301.54-9 explains the APHIS policy that the services of an inspector that are needed to comply with the regulations are provided without cost between 8 a.m. and 4:30 p.m., Monday through Friday, except holidays, to persons requiring those services, but that we will not be responsible for any other costs or charges (such as overtime costs for inspections conducted at times other than between 8 a.m. to 4:30 p.m., Monday through Friday, except holidays).

This proposed rule has been reviewed under Executive Order 12866. The rule has been determined to be significant for the purposes of Executive Order 12866 and, therefore, has been reviewed by the Office of Management and Budget.

We are proposing to establish domestic regulations for the boll weevil ( Anthonomus grandis ) that would restrict the interstate movement of regulated articles within regulated areas and from regulated areas into or through nonregulated areas in commercial cotton-producing States. The proposed regulations would help prevent the artificial spread of boll weevil into noninfested areas of the United States, and the reinfestation of areas from which the boll weevil has been eradicated.

For this proposed rule, we have prepared an economic analysis. The economic analysis, which is set out below, provides a cost-benefit analysis as required by Executive Order 12866 and an analysis of the potential economic effects of this proposed rule on small entities as required by the Regulatory Flexibility Act.

All cotton-producing areas in the United States are either free of boll weevil or in the process of eliminating the pest through State-sanctioned eradication efforts. These initiatives receive Federal support and are collectively referred to as the cooperative boll weevil eradication program. The areas where the boll weevil is still present, but where growers are participating in the eradication efforts, are categorized as suppressive areas. Suppressive areas are present in the States of Arkansas, Louisiana, Mississippi, Missouri, Oklahoma, Tennessee, and Texas. Previously, Texas and other States also contained areas known as generally infested, where producers had not entered into the voluntary State-sanctioned eradication programs. However, these areas have since also joined the cooperative efforts.

Therefore, all cotton-producing areas in the United States are now categorized as either pest-free or suppressive areas, and all areas where the pest is present are involved in eradication. Most areas have already eliminated the boll weevil. The remaining areas that are in the process of doing so are expected to achieve eradication over the next few years. States with suppressive areas impose controls on the intrastate movement of regulated material to pest free areas. These intrastate controls are essentially the same as the proposed interstate regulations.

The primary benefits of the proposed Federal controls on the interstate movement of regulated articles are to help prevent the artificial spread of boll weevil into noninfested areas of the United States, and to strengthen the effort of the States to prevent reinfestation of areas from which the pest has been eradicated. The regulations also are expected to contribute to boll weevil eradication, over and above what would be accomplished under the voluntary cooperative eradication program.

Because the boll weevil is a migratory pest, it is necessary for States to cooperate within regions to ensure the success of control programs. Although individual growers have successfully controlled boll weevils in their fields, neighboring infested areas can contribute to reinfestations. In order to encourage all cotton producers to remain diligent in their participation in eradication activities, we believe that Federal regulations are necessary to restrict the interstate movement of certain articles from areas which may become generally infested in the future and from current suppressive areas to help prevent the artificial spread of the boll weevil to noninfested areas.

Cotton production is an important element of the U.S. agricultural economy. In 2004, cotton production was valued at $5.3 billion, cottonseed production at $874 million, and cotton and cotton products exported at $6.4 billion. The boll weevil is a destructive pest of cotton, and is the principal pest of this major industry. It causes economic losses by lowering the yield and quality of cotton, and heavy infestations can result in complete loss of the crop. The boll weevil arrived in the United States from Mexico in 1892, and has since caused an estimated $22 billion in yield losses and control costs to the U.S. cotton industry.

In those areas where the boll weevil has been eradicated, cotton growers have benefited from lower costs of production because of reduced pesticide use, and from higher yields that have led to increased land values and expanded cotton acreage. Pesticide savings of between 40 and 90 percent have been realized, and many cotton growers have been able to forgo pesticide use entirely. Yield increases of 10 to 20 percent have been achieved in areas where this pest has been eliminated. Without effective quarantine measures, however, these higher yields would not be realized. It is also possible that, because of reinfestation, losses will again begin to mount in areas in which the boll weevil had previously been eradicated.

Boll weevil eradication efforts have provided stability for the U.S. cotton industry and strengthened its ability to compete in the world market. Various formerly infested States or portions of States are now free of this pest. As areas become boll weevil-free, eradication costs have declined. Over the 4-year period 1999-2002, national program costs totaled $1.019 billion, compared to $585 million spent over the following 4 years, 2003-2006. Recent yearly costs have declined rapidly, from $245 million in 2002, to $125 million in 2006. (All dollar amounts are unadjusted for inflation.) The major cost areas are labor, treatments (chemicals and application), trapping supplies, and vehicles and transportation. The APHIS share of these costs has been between 25 and 30 percent. But the benefits exceed even such high expenditures, and extend beyond the cotton industry to related sectors of the national economy as well as to the local economies in cotton-producing areas.

The extent of the reduction in risk that would be achieved with the regulations cannot be determined, since we do not know the likelihood of interstate movement of infested articles from the suppressive areas. However, we do know that reinfestation of areas where the pest had been eradicated can be costly.

The Southeastern Boll Weevil Eradication Foundation has tracked the costs associated with boll weevil reintroductions and reinfestations in six southeastern States between 1987 and 2004. The cost approximations are based on incomplete work unit records, but nonetheless clearly indicate the benefits of prevention and, when reinfestations occur, of limiting their size through early detection and rapid control. About half of the affected counties reported reinfestations in various years that cost less than $10,000, with fewer than 10 weevils discovered. Other counties reported much larger reinfestations and eradication costs, ranging up to $1.3 million spent in Orangeburg County, SC, between 1995 and 1997, where 23,899 weevils were detected and eliminated.

As with the expected benefits, the costs of the proposed regulations would derive from controls on the interstate movement of regulated articles from regulated areas. Costs are expected to be incurred primarily by entities such as custom harvester operators and other agricultural service providers who move regulated articles from the infested areas. Specific costs would depend on the types of regulated articles moved, unit costs of disinfestation, and the frequency of interstate movement.

Methods of boll weevil disinfestation range widely, from hand removal of leaves and sweeping of foreign material with brooms, to more costly methods such as compressed air blowing, high-pressure washing, and fumigation. Unit costs also range widely, from $4 for hand sweeping of a truck bed, to as much as $800 for the fumigation of harvesting equipment such as pickers and strippers.

Relatively few cotton growers or gin operators are expected to be affected, since most cotton is grown and ginned within the same area, and baled cotton and cottonseed are not regulated articles. Custom harvesters and other agricultural service providers who move regulated articles from infested areas would be affected, but the impact on such entities is not expected to be large. Fumigation of a cotton harvester is estimated to cost about $800, less than 1 percent of annual receipts for a representative operator. APHIS estimates that as many as 100 custom harvesters would be affected by this rule. With establishment of the proposed regulations, owners of such equipment could be expected to schedule harvesting contracts so as to minimize the number of interstate movements from infested areas during a season.

APHIS is proposing that each cotton-producing State, or legally defined zone within a State, would be designated as a regulated area when growers fail to maintain minimum pest surveillance and control activities to prevent reinfestation of that area as well as surrounding areas by the boll weevil. These activities would consist of the annual installation and monitoring of boll weevil pheromone traps, and the application of effective control measures if boll weevils are detected. Failure by cotton growers within a State or zone where boll weevil is not known to be present to maintain prescribed minimum standards of detection and control would result in the area being listed as a regulated area. The cost of these activities should be less than $2 per acre, but may vary depending on proximity to regulated areas. Under the current boll weevil eradication program, surveillance and control activities are already required in areas from which the pest has been eradicated. We expect that these surveillance and control costs would continue to be incurred even without promulgation of this rule.

A numerical comparison of expected benefits and costs of the regulations is not possible, since we cannot estimate the reduction in the risk of spread that would be attributable to the proposed regulations, nor can we predict aggregate expenditures by directly affected entities. However, given the sizable benefits that boll weevil eradication has afforded cotton growers and others in areas where this pest has been eliminated and the relatively small cost of disinfestation of regulated articles moved interstate, APHIS believes the net benefit of the regulations would be positive.

Costs to APHIS of administering the rule would differ little from the Agency's current costs of participating with producers and States in the National Boll Weevil Cooperative Control Program, whereby APHIS is contributing about 25 to 30 percent of total eradication expenditures. Federal appropriations for the program have fallen from about $77 million in 2002, to less than $39 million in 2006. Once nationwide eradication has been accomplished, APHIS participation in funding post-eradication annual surveys, expected to cost between $5 million and $7 million per year, would depend on Congressional direction. The cost to APHIS of funding eradication activities in areas that become reinfested depends on the size of the outbreak, and has ranged from tens of thousands to hundreds of thousands of dollars.

An alternative to the regulations would be to take no action, that is, not establish Federal controls on the interstate movement of regulated articles. If this alternative were selected, nationwide eradication could be delayed. There would be increased risk of reinfestation and production losses in cotton-producing areas where the pest has been eliminated. Current State regulations have been fairly effective in preventing the artificial movement of boll weevils from infested areas into noninfested areas. However, the long-term protection of these areas can be significantly enhanced by the proposed Federal regulations.

The Regulatory Flexibility Act requires agencies to evaluate the potential effects of their proposed rules on small entities. We address here the requirements of an initial regulatory flexibility analysis, and welcome public comment on expected small entity effects of this rule.

APHIS is proposing Federal controls on the interstate movement of regulated articles to help prevent the artificial spread of the boll weevil into noninfested areas of the United States. Most commercial cotton-producing areas of the United States have already eliminated the boll weevil. Complete elimination of this pest is expected to be achieved over the next few years, as long as reinfestation of areas from which the pest has been eradicated is prevented. Through the cooperative boll weevil eradication program, States with suppressive areas, that is, areas in the process of eliminating the pest through APHIS-endorsed, area-wide control programs, impose controls on the intrastate movement of regulated material to pest-free areas. The proposed interstate movement restrictions would complement these intrastate controls. The rule is expected to contribute to boll weevil eradication, over and above what would be accomplished under the voluntary cooperative eradication program.

The objective of the proposed rule is to minimize risks of infestation or reinfestation of boll weevil-free areas through the interstate movement of regulated articles and thereby hasten the Nation's eradication of this pest. Current State regulations have been fairly effective in preventing the artificial movement of the boll weevil from infested areas into noninfested areas. The long-term protection of noninfested areas can be significantly enhanced by the proposed regulations.

In accordance with the Plant Protection Act (7 U.S.C. 7701 et seq. ), the Secretary of Agriculture has the authority to promulgate regulations and take measures to prevent the spread of plant pests within the United States, which includes regulating the interstate movement of any product, article, or means of conveyance that presents a risk of spreading the boll weevil.

The principal entities engaged in cotton production—growers, gin operators, and agricultural service providers such as custom harvesters—are mainly small entities, and the economic effects for them would be the same as has been described generally. Small entities in nonregulated areas would benefit from a reduced risk of boll weevil infestation. Entities that move regulated articles from infested areas into noninfested areas would bear certain costs of complying with the regulations.

As indicated in table 1, more than 81 percent of cotton farms and more than 76 percent of ginning establishments are small entities, based on small-entity definitions of annual receipts of not more than $750,000 and not more than $6.5 million, respectively. Small entity cotton farms and ginning establishments in areas free of the boll weevil would benefit from the reduction in risk of infestation or reinfestation provided by the rule.

The soil preparation, planting, and cultivation industry includes businesses that provide fertilizer and cultivation services; soil treatments; crop spraying; and disease, insect, or weed control services. Small entities in this industry are establishments that have annual receipts of not more than $6.5 million. Information is not available on the percentage of these establishments that are small, but we expect that they represent the majority, since 96 percent of these businesses have fewer than 20 employees. We are unable to estimate the number of small entity agricultural service providers that may be affected by this rule.

Similarly, the small entity definition for harvesting operations is annual receipts of not more than $6.5 million. While we do not know the percentage of these establishments with receipts that fall below this threshold, we note that 92 percent of harvesting businesses have fewer than 20 employees. Custom harvesters and other agricultural service providers are types of firms that may be affected by the proposed rule because of their movement from regulated areas to or through nonregulated areas. APHIS estimates that as many as 100 small entity cotton harvester operators may be affected by this rule.

The information shown in table 1 on numbers of establishments in the soil preparation, planting, and cultivating industry and in the crop harvesting industry is for all crops. We believe the predominance of small entities in these industries overall holds as well for the cotton sector.

APHIS welcomes information that the public may provide on the number of small entities in the identified industries that may be affected by the proposed rule, as well as information on small entities in other industries that the public believes may be affected.

Regulated articles moving interstate from regulated areas would be required to be accompanied by a certificate or a limited permit if moved into nonregulated, commercial cotton-producing areas. The proposed rule would also provide for the use of compliance agreements, for the convenience of persons who are involved in the growing, handling, or moving of regulated articles from regulated areas. The reporting and recordkeeping requirements associated with this proposed rule are described below under “Paperwork Reduction Act.”

Relatively few cotton growers or gin operators are expected to be affected by the proposed rule, since most cotton is grown and ginned within the same area, and baled cotton and cottonseed are not regulated articles. The largest treatment cost may be borne by operators of harvesters and other major machinery. Based on a unit fumigation cost for harvesting equipment of $800, and a single movement per season from a regulated to a nonregulated area, the cost per harvester would be $800, and industry-wide, $80,000, assuming 100 harvesting equipment operators would be affected. 3 The fumigation cost per harvester and the single movement per season requiring fumigation are APHIS estimates based on information provided by industry. This annual cost of $800 is estimated to be less than 1 percent of annual receipts for a representative operator. APHIS welcomes public comment that would enable us to more fully understand possible costs associated with the proposed rule's compliance requirements.

Growers in areas from which the boll weevil has been eradicated would be required to maintain minimum weevil surveillance and control activities to prevent reinfestation, whether or not they move regulated articles interstate. Since these surveillance and control activities are already required under the current boll weevil eradication program in areas from which the pest has been eradicated, their cost (estimated by APHIS to average about $2 per acre per year) would continue to be incurred without this rule. Therefore, the cost of these activities for small-entity cotton producers is not attributable to the proposed rule.

We do not expect the rule to have a significant impact on entities, large or small, and therefore have not set forth alternatives intended to minimize significant impacts on 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 proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. If this proposed rule is adopted: (1) All State and local laws and regulations that are inconsistent with this rule will be preempted; (2) no retroactive effect will be given to this rule; and (3) administrative proceedings will not be required before parties may file suit in court challenging this rule.

To provide the public with documentation of APHIS' review and analysis of any potential environmental impacts associated with the proposed domestic boll weevil quarantine program, we have prepared an environmental assessment. The environmental assessment was prepared in accordance with: (1) The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq. ), (2) regulations of the Council on Environmental Quality for implementing the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA Implementing Procedures (7 CFR part 372).

The environmental assessment may be viewed on the Regulations.gov Web site or in our reading room. (Instructions for accessing Regulations.gov and information on the location and hours of the reading room are provided under the heading ADDRESSES at the beginning of this proposed rule). In addition, copies may be obtained by calling or writing to the individual listed under FOR FURTHER INFORMATION CONTACT .

In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ), the information collection or recordkeeping requirements included in this proposed rule have been submitted for approval to the Office of Management and Budget (OMB). Please send written comments to the Office of Information and Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington, DC 20503. Please state that your comments refer to Docket No. APHIS-2006-0002. Please send a copy of your comments to: (1) Docket No. APHIS-2006-0002, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238, and (2) Clearance Officer, OCIO, USDA, Room 404-W, 14th Street and Independence Avenue, SW., Washington, DC 20250. A comment to OMB is best assured of having its full effect if OMB receives it within 30 days of publication of this proposed rule.

We are proposing to establish domestic boll weevil regulations that would restrict the interstate movement of regulated articles within regulated areas and from regulated areas into or through nonregulated areas in commercial cotton-producing States. The proposed regulations would help prevent the artificial spread of boll weevil into noninfested areas of the United States and the reinfestation of areas from which the boll weevil has been eradicated. Because the boll weevil is a migratory pest, it is necessary for States to cooperate within regions to ensure the success of the eradication program.

Implementation of this regulation would require us to engage in certain information collection activities, which in turn necessitates the use of forms. Forms we plan to use to implement and enforce the program include compliance agreements, limited permits, and certificates. We described these documents in greater detail previously in this document.

We are soliciting comments from the public (as well as affected agencies) concerning our proposed information collection and recordkeeping requirements. These comments will help us:

(1) Evaluate whether the proposed information collection is necessary for the proper performance of our agency's functions, including whether the information will have practical utility;

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

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

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

Estimate of burden: Public reporting burden for this collection of information is estimated to average 1 hour per response.

Respondents: Cotton growers, cotton gin operators, custom harvesters.

Estimated annual number of respondents: 1,025

Estimated annual number of responses per respondent: 1.

Estimated annual number of respondents: 1,025.

Estimated total annual burden on respondents: 1,025 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)

Copies of this information collection can be obtained from Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 734-7477.

The Animal and Plant Health Inspection Service is committed to compliance with the E-Government Act to promote the use of the Internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. For information pertinent to E-Government Act compliance related to this proposed rule, please contact Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 734-7477.

Accordingly, we propose to amend 7 CFR part 301, as follows:

We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special condition, explain the reason for any recommended change, and include supporting data. We ask that you send us two copies of written comments.

We will file in the docket all comments we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning this special condition. You can inspect the docket before and after the comment closing date. If you wish to review the docket in person, go to the address in the ADDRESSES section of this preamble between 7:30 a.m. and 4 p.m., Monday through Friday, except Federal holidays.

We will consider all comments we receive on or before the closing date for comments. We will consider comments filed late if it is possible to do so without incurring expense or delay. We may change this special condition based on the comments we receive.

If you want the FAA to acknowledge receipt of your comments on this proposal, include with your comments a pre-addressed, stamped postcard on which the docket number appears. We will stamp the date on the postcard and mail it back to you.

On June 5, 2002, The Boeing Company, P.O. Box 3707, Seattle, Washington 98124, applied for an amendment to Type Certificate No. A16WE to include the new Model 737-900ER. The Model 737-900ER, which is a derivative of the Model 737-900 currently approved under A16WE, is a large transport airplane with two flight crew and the capacity to carry 215 passengers. The airplane is powered by two CFM 56-7B or CFM-567B/2 series turbofan engines.

Under the provisions of § 21.101, Boeing must show that the Model 737-900ER meets the applicable provisions of 14 CFR part 25, as amended by Amendments 25-1 through 25-108, except for earlier amendments as agreed upon by the FAA. These regulations will be incorporated into the Type Certificate No. A16WE after type certification approval of the 737-900ER.

In addition, the certification basis includes other regulations, special conditions and exemptions that are not relevant to this proposed special condition. Refer to Type Certificate No. A16WE for a complete description of the certification basis for this model airplane.

If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for the Model 737-900ER because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

In addition to the applicable airworthiness regulations and special conditions, the Model 737-900ER must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34 and the noise certification requirements of 14 CFR part 36.

The FAA issues special conditions, as defined in § 11.19, under § 11.38, and they become part of the type certification basis under § 21.101.

Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same or similar novel or unusual design feature, or should any other model already included on the same type certificate be modified to incorporate the same or similar novel or unusual design feature, the special conditions would also apply to the other model under § 21.101.

Model 737-900ER airplane will incorporate novel or unusual design features. This proposed special condition addresses equipment which may affect the airplane's structural performance, either directly or as a result of failure or malfunction.

This proposed special condition is identical or nearly identical to those previously required for type certification of other Boeing airplane models. The proposed special condition was derived initially from standardized requirements developed by the Aviation Rulemaking Advisory Committee (ARAC), comprised of representatives of the FAA, Europe's Joint Aviation Authorities (now replaced by the European Aviation Safety Agency), and industry.

In addition to the requirements of part 25, subparts C and D, the following special condition applies.

The Boeing Model 737-900ER is equipped with systems that may affect the airplane's structural performance either directly or as a result of failure or malfunction. The effects of these systems on structural performance must be considered in the certification analysis. This analysis must include consideration of normal operation and of failure conditions with required structural strength levels related to the probability of occurrence.

As discussed above, this special condition is applicable to the Boeing Model 737-900ER. Should Boeing apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, this special condition would apply to that model as well.

Certification of the Model 737-900ER is currently scheduled for February 2007. Because a delay would significantly affect the applicant's installation of the systems and certification of the airplane we are shortening the public comment period to 20 days.

This action affects only certain novel or unusual design features on one model of airplane. It is not a rule of general applicability.

The authority citation for these special conditions is as follows:

Accordingly, the Federal Aviation Administration (FAA) proposes the following special condition as part of the type certification basis for Boeing Model 737-900ER airplanes.

In addition to the requirements of part 25, subparts C and D, the following proposed special condition would apply:

a. For airplanes equipped with systems that affect structural performance—either directly or as a result of a failure or malfunction—the influence of these systems and their failure conditions must be taken into account when showing compliance with the requirements of part 25, subparts C and D. Paragraph b, below, must be used to evaluate the structural performance of airplanes equipped with these systems.

b. Interaction of Systems and Structures.

(1) General: The following criteria must be used for showing compliance with this special condition for interaction of systems and structures and with § 25.629 for airplanes equipped with flight control systems, autopilots, stability augmentation systems, load alleviation systems, flutter control systems, and fuel management systems.

(a) The criteria defined herein address only the direct structural consequences of the system responses and performances. They cannot be considered in isolation but should be included in the overall safety evaluation of the airplane. These criteria may, in some instances, duplicate standards already established for this evaluation. These criteria are applicable only to structures whose failure could prevent continued safe flight and landing. Specific criteria that define acceptable limits on handling characteristics or stability requirements when operating in the system degraded or inoperative modes are not provided in this special condition.

(b) Depending upon the specific characteristics of the airplane, additional studies may be required that go beyond the criteria provided in this special condition in order to demonstrate the capability of the airplane to meet other realistic conditions, such as alternative gust or maneuver descriptions for an airplane equipped with a load alleviation system.

(c) The following definitions are applicable to this paragraph.

Structural performance: Capability of the airplane to meet the structural requirements of part 25.

Flight limitations: Limitations that can be applied to the airplane flight conditions following an in-flight occurrence and that are included in the flight manual (e.g., speed limitations and avoidance of severe weather conditions).

Operational limitations: Limitations, including flight limitations, that can be applied to the airplane operating conditions before dispatch (e.g., fuel, payload, and Master Minimum Equipment List limitations).

Probabilistic terms: The probabilistic terms (probable, improbable, and extremely improbable) used in this special conditions are the same as those used in § 25.1309.

Failure condition: The term failure condition is the same as that used in § 25.1309. However, this special condition applies only to system failure conditions that affect the structural performance of the airplane (e.g., system failure conditions that include loads, change the response of the airplane to inputs as gusts or pilot actions, or lower flutter margins).

(2) Effects of Systems on Structures.

(a) General. The following criteria will be used in determining the influence of a system and its failure conditions on the airplane structure.

(b) System fully operative. With the system fully operative, the following apply:

(1) Limit loads must be derived in all normal operating configurations of system from all the limit conditions specified in subpart C ( or used in lieu of those specified in subpart C), taking into account any special behavior of such a system or associated functions or any effect on the structural performance of the airplane that may occur up to the limit loads. In particular, any significant non-linearity (rate of displacement of control surface, thresholds or any other system non-linearities) must be accounted for in a realistic or conservative way when deriving limit loads from limit conditions.

(2) The airplane must meet the strength requirements of part 25 (static strength, residual strength), using the specified factors to derive ultimate loads from the limit loads defined above. The effect of non-linearities must be investigated beyond limit conditions to ensure that the behavior of the system presents no anomaly compared to the behavior below limit conditions. However, conditions beyond limit conditions need not be considered, when it can be shown that the airplane has design features that will not allow it to exceed those limit conditions.

(3) The airplane must meet the aeroelastic stability requirements of § 25.629.

(c) System in the failure condition. For any system failure condition not shown to be extremely improbable, the following apply:

(1) At the time of occurrence. Starting from 1g level flight conditions, a realistic scenario, including pilot corrective actions, must be established to determine the loads occurring at the time of failure and immediately after failure.

(i) For static strength substantiation, those loads multiplied by an appropriate factor of safety that is related to the probability of occurrence of the failure are ultimate loads to be considered for design. The factor of safety (FS) is defined in Figure 1.

(ii) For residential strength substantiation, the airplane must be able to withstand two thirds of the ultimate loads defined in paragraph (c)(1)(i) of this section. For pressurized cabins, these loads must be combined with the normal operating differential pressure.

(iii) Freedom from aeroelastic instability must be shown up to the speeds defined in § 25.629(b)(2). For failure conditions that result in speed increases beyond V c /M c , freedom from aeroelastic instability must be shown to those increased speeds, so that the margins intended by § 25.629(b)(2) are maintained.

(vi) Failures of the system that result in forced structural vibrations (oscillatory failures) must not produce loads that could result in detrimental deformation of primary structure.

(2) For the continuation of the flight. For the airplane in the system failed state and considering any appropriate reconfiguration and flight limitations, the following apply:

(i) The loads derived from the following conditions (or used in lieu of the following conditions) at speeds up to V c /M c or the speed limitation prescribed for the remainder of the flight must be determined:

(A) The limit symmetrical maneuvering conditions specified in §§ 25.331 and 25.345.

(B) The limit gust and turbulence conditions specified in §§ 25.341 and in 25.345.

(C) The limit rolling conditions specified in § 25.349 and limit unsymmetrical conditions specified in §§ 25.367 and 25.427(b) and (c).

(D) The limit yaw maneuvering conditions specified in § 25.351.

(E) The limit ground loading conditions specified in §§ 25.473 and 25.491.

(ii) For static strength substantiation, each part of the structure must be able to withstand the loads in paragraph (c)(2)(i) of this special condition multiplied by a factor of safety, depending on the probability of being in this failure state. The factor of safety is defined in Figure 2.

(iii) For residual strength substantiation, the airplane must be able to withstand two thirds of the ultimate loads defined in paragraph (c)(2)(ii). For pressurized cabins, these loads must be defined combined with the normal operating differential pressure.

(iv) If the loads induced by the failure condition have a significant effect on fatigue or damage tolerance, then their effects must be taken into account.

(v) Freedom from aeroelastic instability must be shown up to a speed determined from Figure 3. Flutter clearance speeds V′ and V″ may be based on the speed limitation specified for the remainder of the flight, using the margins defined by § 25.629(b).

(vi) Freedom from aeroelastic instability must also be shown up to V′ in Figure 3 above for any probable system failure condition combined with any damage required or selected for investigation by § 25.571(b).

(3) Consideration of certain failure conditions may be required by other sections of this Part, regardless of calculated system reliability. Where analysis shows the probability of these failure conditions to be less than 10 −9 , criteria other than those specified in this paragraph may be used for structural substantiation to show continued safe flight and landing.

(d) Warning considerations. For system failure detection and warning, the following apply:

(1) The system must be checked for failure conditions, not extremely improbably, that degrade the structural capability below the level required by part 25 or significantly reduce the reliability of the remaining system. As far as reasonably practicable, the flightcrew must be made aware of these failures before flight. Certain elements of the control system, such as mechanical and hydraulic components, may use special periodic inspections, and electronic components may use daily checks in lieu of warning systems to achieve the objective of this requirement. These certification maintenance requirements must be limited to components the failures of which are not readily detectable by normal warning systems and where service history shows that inspections will provide an adequate level of safety.

(2) The existence of any failure condition, not extremely improbable, during flight that could significantly affect the structural capability of the airplane and for which the associated reduction in airworthiness can be minimized by suitable flight limitations must be signaled to the flightcrew. For example, failure conditions that result in a factor of safety between the airplane strength and the loads of part 25, subpart C, below 1.25 or flutter margins below V″ must be signaled to the crew during flight.

(e) Dispatch with known failure conditions. If the airplane is to be dispatched in a known system failure condition that affects structural performance or affects the reliability of the remaining system to maintain structural performance, then the provisions of this Special Condition must be met, including the provisions of paragraph (b), for the dispatched condition and paragraph (c) for subsequent failures. Expected operational limitations may be taken into account in establishing P) j as the probability of failure occurrence for determining the safety margin in Figure 1. Flight limitations and expected operational limitations may be taken into account in establishing Q j as the combined probability of being in the dispatched failure condition and the subsequent failure condition for the safety margins in Figures 2 and 3. These limitations must be such that the probability of being in this combined failure state and then subsequently encountering limit load conditions is extremely improbable. No reduction in these safety margins is allowed, if the subsequent system failure rate is greater than 1E-3 per flight hour.

Comments Invited

We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special condition, explain the reason for any recommended change, and include supporting data. We ask that you send us two copies of written comments.

We will file in the docket all comments we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning this special condition. You can inspect the docket before and after the comment closing date. If you wish to review the docket in person, go to the address in the ADDRESSES section of this preamble between 7:30 a.m. and 4 p.m., Monday through Friday, except Federal holidays.

We will consider all comments we receive on or before the closing date for comments. We will consider comments filed late if it is possible to do so without incurring expense or delay. We may change this special condition based on the comments we receive.

If you want the FAA to acknowledge receipt of your comments on this proposal, include with your comments a pre-addressed, stamped postcard on which the docket number appears. We will stamp the date on the postcard and mail it back to you.

On December 19, 2005, Gulfstream Aerospace Corporation applied for a change to Type Certificate No. A12EA to use a hydrophobic windshield coating as the sole means of providing adequate pilot compartment view in the presence of precipitation for Gulfstream Model GV, GV-SP and GIV-X airplanes. The Gulfstream Model GV, GV-SP and GIV-X airplanes are currently approved under Type Certificate No. A12EA. The Model GV airplane is powered by two BMW-Rolls Royce Deutschland BR700-710A1-10 engines, operates with a two person flightcrew, and has the capacity to carry 19 passengers. The Model GV-SP airplane is powered by two BMW-Rolls Royce Deutschland BR700-710C4-11 engines, operates with a two person flightcrew, and has the capacity to carry 19 passengers. The Model GIV-X airplane is powered by two Rolls Royce Tay Mark 611-8C engines, operates with a two person flightcrew, and has the capacity to carry 19 passengers.

Under the provisions of § 21.101, Gulfstream Aerospace Corporation must show that the Model GV, GV-SP and GIV-X airplanes, as changed, continue to meet the applicable provisions of the regulations incorporated by reference in Type Certificate No. A12EA, or the applicable regulations in effect on the date of application for the change. The regulations incorporated by reference in the type certificate are commonly referred to as the “original type certification basis.”

The regulations incorporated by reference in Type Certificate No. A12EA include:

• For Model GV airplanes—part 25, effective February 1, 1965, Amendment 25-1 through Amendment 25-81, with exceptions.

• For Model GV-SP airplanes—part 25, effective February 1, 1965, Amendment 25-1 through Amendment 25-98.

• For Model GIV-X airplanes—part 25, effective February 1, 1965, Amendment 25-1 through Amendment 25-101, with exceptions.

In addition, the certification basis includes other regulations, special conditions and exemptions that are not relevant to this proposed special condition.

If the Administrator finds that the applicable airworthiness regulations ( i.e. , 14 CFR part 25) do not contain adequate or appropriate safety standards for the Model GV, GV-SP and GIV-X airplanes because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

In addition to the applicable airworthiness regulations and special conditions, the Model GV, GV-SP and GIV-X airplanes must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34 and the noise certification requirements of 14 CFR part 36.

The FAA issues special conditions, as defined in § 11.19, under § 11.38, and they become part of the type certification basis under § 21.101.

Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same or similar novel or unusual design feature, or should any other model already included on the same type certificate be modified to incorporate the same or similar novel or unusual design feature, the special conditions would also apply to the other model under § 21.101.

The Gulfstream Model G-V, GV-SP and GIV-X flightdeck designs incorporate a hydrophobic windshield coating to provide adequate pilot compartment view in the presence of precipitation. Sole reliance on such a coating, without windshield wipers or a windshield blower, constitutes a novel or unusual design feature for which the applicable airworthiness regulations do not contain adequate or appropriate safety standards. Therefore, special conditions are required that provide the level of safety equivalent to that established by the regulations.

Section 25.773(b)(1) requires that both pilots of a transport category airplane be provided a means to maintain a sufficiently clear portion of the windshield during precipitation conditions, and that this clear portion of the windshield must have a sufficiently extensive view along the flight path. The regulations require this means to maintain such an area during precipitation in heavy rain at speeds up to 1.5 V SR1 .

This requirement has existed in principle since 1953 in Part 4b of the Civil Air Regulations (CAR). Section 4b.351(b)(1) of CAR 4b required that “Means shall be provided for maintaining a sufficient portion of the windshield clear so that both pilots are afforded a sufficiently extensive view along the flight path in all normal flight attitudes of the airplane. Such means shall be designed to function under the following conditions without continuous attention on the part of the crew: (i) In heavy rain at speeds up to 1.6 V S1 , flaps retracted.” Effective December 26, 1990, Amendment 25-108 changed the criterion for effectiveness of the means to maintain an area of clear vision from 1.6 V S1 to 1.5 V SR1 to accommodate the redefinition of the reference stall speed as the 1-g stall speed. As noted in the preamble to the final rule for that amendment, the 7 percent decrease in the speed value offsets a corresponding increase in the reference stall speed associated with the use of V SR1 rather than V S1 .

The requirement that the means to maintain a clear area of forward vision must function at high speeds and high precipitation rates is based on the use of windshield wipers as the means to maintain an adequate area of clear vision in precipitation conditions. The requirement in 14 CFR 121.313(b), and in 14 CFR 125.213(b), to provide “a windshield wiper or equivalent for each pilot station” has remained unchanged since at least 1953.

The effectiveness of windshield wipers to maintain an area of clear vision normally degrades as airflow and precipitation rates increase. It is assumed that because high speeds and high precipitation rates represent limiting conditions for windshield wipers, they will also be effective at lower speeds and precipitation levels. Accordingly, § 25.773(b)(1)(i) does not require maintenance of a clear area of forward vision at lower speeds or lower precipitation rates.

A forced air stream blown over the windshield has also been used to maintain an area of clear vision in precipitation. The limiting conditions for this technology are comparable to those for windshield wipers. Accordingly, introduction of this technology did not present a need for special conditions to maintain the level of safety embodied in the existing regulations.

Hydrophobic windshield coatings may depend to some degree on airflow to maintain a clear vision area. The heavy rain and high-speed conditions specified in the current rule do not necessarily represent the limiting conditions for this new technology. For example, airflow over the windshield, which may be necessary to remove moisture from the windshield, may not be adequate to maintain a sufficiently clear area of the windshield in low speed flight or during surface operations. Alternatively, airflow over the windshield may be disturbed during such critical times as the approach to land, where the airplane is at a higher than normal pitch attitude. In these cases, areas of airflow disturbance or separation on the windshield could cause failure to maintain a clear vision area on the windshield.

In addition to potentially depending on airflow to function effectively, hydrophobic coatings may also be dependent on water droplet size for effective precipitation removal. For example, precipitation in the form of a light mist may not be sufficient for the coating's properties to result in maintaining a clear area of vision.

In summary, the current regulations identify speed and precipitation rate requirements that represent limiting conditions for windshield wipers and blowers, but not for hydrophobic coatings, so it is necessary to issue special conditions to maintain the level of safety represented by the current regulations.

These special conditions provide an appropriate safety standard for the hydrophobic coating technology as the sole means to maintain a clear area of vision by requiring it to be effective at low speeds and precipitation rates as well as the higher speeds and precipitation rates identified in the current regulation. These are the only new or changed requirements relative to those in § 25.773(b)(1) at Amendment 25-108.

As discussed above, this special condition is applicable to Gulfstream Model GV, GV-SP and GIV-X airplanes. Should Gulfstream Aerospace Corporation apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, the special condition would apply to that model as well.

The substance of this special condition has been subject to the notice and public comment procedure in several prior instances. Therefore, because a delay would significantly affect scheduled airplane deliveries, we are shortening the public comment period to 20 days.

This action affects only certain novel or unusual design features on Gulfstream Model GV, GV-SP, and GIV-X airplanes. It is not a rule of general applicability.

The authority citation for these special conditions is as follows:

Accordingly, the Federal Aviation Administration (FAA) proposes the following special condition as part of the type certification basis for Gulfstream Aerospace Corporation Model GV, GV-SP, and GIV-X airplanes.

The airplane must have a means to maintain a clear portion of the windshield, during precipitation conditions, enough for both pilots to have a sufficiently extensive view along the ground or flight path in normal taxi and flight attitudes of the airplane. This means must be designed to function, without continuous attention on the part of the crew, in conditions from light misting precipitation to heavy rain at speeds from fully stopped in still air, to 1.5 V SR1 with lift and drag devices retracted.

Comments Invited

Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2006-25947/Airspace Docket No. 06-AAL-31.” The postcard will be date/time stamped and returned to the commenter.

All communications received on or before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of comments received. All comments submitted will be available for examination in the public docket both before and after the closing date for comments. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.

An electronic copy of this document may be downloaded through the Internet at http://dms.dot.gov. Recently published rulemaking documents can also be accessed through the FAA's Web page at http://www.faa.gov or the Superintendent of Document's Web page at http://www.access.gpo.gov/nara.

Additionally, any person may obtain a copy of this notice by submitting a request to the Federal Aviation Administration, Office of Air Traffic Airspace Management, ATA-400, 800 Independence Avenue, SW., Washington, DC 20591 or by calling (202) 267-8783. Communications must identify both docket numbers for this notice. Persons interested in being placed on a mailing list for future NPRM's should contact the FAA's Office of Rulemaking, (202) 267-9677, to request a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure.

The FAA is considering an amendment to the Code of Federal Regulations (14 CFR Part 71), which would revise the Class D and E airspace descriptions at Allen AAF, AK resulting from a change in the hours of activation at the Allen AAF Control Tower. The intended effect of this proposal is to adjust the Class D airspace activation time to align with the Allen AAF tower hours of operation. The class D airspace would only be in place while the tower is manned. The Class D airspace area will be effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory.

The Army does not need to operate the control tower 24 hours per day. Class D airspace is only in effect when a tower is open. When the tower is not open, the airspace would revert to Class E. Additionally, the title of each airspace description in FAA Order 7400.9P associated with Allen AAF would be changed. By convention, these titles are associated with the nearest city or town. In this case, “Delta Junction” should be referenced (not “Big Delta”). For example, the Class E5 airspace should be titled: “AAL AK E5 Delta Junction, AK”. There is a smaller town named Big Delta about 10 miles further north of Delta Junction. It has been mistakenly listed in the description since 1995. This action would correct that error. The proposed airspace changes are sufficient in size to contain aircraft executing instrument procedures at Allen AAF, AK.

The area would be depicted on aeronautical charts for pilot reference. The coordinates for this airspace docket are based on North American Datum 83. The Class D airspace areas designated as 700/1200 foot transition areas are published in paragraph 6005 in FAA Order 7400.9P, Airspace Designations and Reporting Points, dated September 1, 2006, and effective September 15, 2006, which is incorporated by reference in 14 CFR 71.1. The Class D and E airspace designations listed in this document would be published subsequently in the Order.

The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle 1, section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority.

This rulemaking is promulgated under the authority described in subtitle VII, part A, subpart 1, section 40103, Sovereignty and use of airspace. Under that section, the FAA is charged with prescribing regulations to ensure the safe and efficient use of the navigable airspace. This regulation is within the scope of that authority because it proposes changes to Class D and E airspace that remain sufficient in size to contain aircraft executing instrument procedures at Allen AAF and represents the FAA's continuing effort to safely and efficiently use the navigable airspace.

In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:

In the Federal Register of August 29, 2006 (71 FR 51276), FDA published a proposed rule entitled “Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs” (proposed rule). The proposed revisions would reorganize, consolidate, clarify, and modify current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products (including vaccines and allergenic products), and/or human cells, tissues, and cellular and tissue-based products, and animal drugs.

The proposed rule would make certain changes to the NDC system and add a requirement that the appropriate NDC number appear on the labels of all drugs subject to the listing requirements. The NDC number is a widely used identifier for drugs. It is a unique 10-digit number consisting of 3 segments: The labeler code, the product code, and the package code. NDC numbers are an important, standardized identification system for drug products used in data or claims processing and for a variety of other purposes where identification of drug products is essential. For more information regarding the NDC number, how it originated, and how it is used, see the preamble of the proposed rule (71 FR 51276 at 51295 to 51296). In the proposed rule, FDA is not proposing to change the format of the NDC number (although comments are welcome on this topic), but is proposing to change the processes for assigning and displaying the NDC number. FDA's proposed changes to the NDC number are described in detail in section IV.C of the preamble of the proposed rule (71 FR 51276 at 51295 through 51306).

In a letter dated October 20, 2005, the Healthcare Distribution Management Association (HDMA), a trade association representing drug distributors, requested that before publishing the proposed rule, FDA hold a public meeting on issues related to changes to the NDC system. FDA responded by letter dated December 14, 2005, that we planned to hold a public meeting on NDC changes during the comment period following publication of the proposed rule. We stated that doing so after the proposal was published would give interested parties the benefit of reviewing the agency's proposal prior to the meeting, which would facilitate more focused comments during the meeting on issues raised in the proposed rule.

As requested, we are holding a public meeting to discuss changes to the NDC system contained in the proposed rule. We emphasize that discussion at this public meeting will be limited to NDC-related issues and will not include any other registration or listing issues. Persons wishing to comment on other aspects of the proposed rule should do so by submitting their comments, in writing, as directed in the proposal.

We anticipate that discussions will include presentations from FDA personnel, invited speakers, and members of the public. We invite discussion of NDC-related topics raised in the proposed rule, including the following:

1. The proposed requirement that human-readable NDC numbers appear on the labels of drugs subject to the drug listing requirements (see 71 FR 51276 at 51297).

2. The proposed requirement that the “appropriate NDC number” that must appear on the labels of drugs is the NDC number of the last manufacturer, repacker or relabeler (including a drug product salvager who repacks or relabels the drug), or private label distributor responsible for the drug immediately before it is received by the wholesaler or retailer (see 71 FR 51276 at 51297 to 51298).

3. The proposed requirement that the human-readable NDC number be immediately preceded by the prefix “NDC” (see 71 FR 51276 at 51298).

4. The proposal to designate the responsibility of assigning the NDC number to FDA (see 71 FR 51276 at 51299).

The act, as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Public Law 94-295), the Safe Medical Devices Act of 1990 (SMDA) (Public Law 101-629), and the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115), among other amendments, established a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the act (21 U.S.C. 360c) established three categories (classes) of devices, depending on the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).

The 1976 amendments broadened the definition of “device” in section 201(h) of the act (21 U.S.C. 321(h)) to include certain articles that were once regulated as drugs. Under the 1976 amendments, Congress classified all transitional devices, i.e., those devices previously regulated as new drugs, including the absorbable hemostatic device, into class III. SMDA amended section 520(l) of the act (21 U.S.C. 360j(l)) to direct FDA to collect certain safety and effectiveness information from the manufacturers of transitional devices still remaining in class III to determine whether the devices should be reclassified into class II (special controls) or class I (general controls). The legislative history of the SMDA reflects congressional concern that many transitional devices were being overregulated in class III (H. Rept. 808, 101st Cong., 2d sess. 26-27 (1990); S. Rept. 513, 101st Cong., 2d sess. 27 (1990)).

Accordingly, in the Federal Register of November 14, 1991 (56 FR 57960), FDA issued an order under section 520(l)(5)(A) of the act, requiring manufacturers of transitional devices, including the absorbable hemostatic device (21 CFR 878.4490), to submit to FDA a summary of and a citation to any information known or otherwise available to them respecting the devices, including adverse safety or effectiveness information, which had not been submitted under section 519 of the act (21 U.S.C. 360i).

Manufacturers were to submit the summaries and citations to FDA by January 13, 1992. However, because of misunderstandings and uncertainties regarding the information required by the order, and whether the order applied to certain manufacturers' devices, many transitional class III device manufacturers failed to comply with the reporting requirement by January 13, 1992. Consequently, in the Federal Register of March 10, 1992 (57 FR 8462), FDA extended the reporting period to March 31, 1992.

Section 520(l)(5)(B) of the act provides that, after the issuance of an order requiring manufacturers to submit any information known or otherwise available respecting the devices, but before December 1, 1992, FDA was to publish regulations either leaving transitional class III devices in class III or reclassifying them into class I or II. Subsequently, as permitted by section 520(l)(5)(C) of the act, in the Federal Register of November 30, 1992 (57 FR 56586), the agency published a notice extending the period for issuing such regulations until December 1, 1993. Due to limited resources, FDA was unable to publish the regulations before the December 1, 1993, deadline.

In the Federal Register of December 16, 1977 (42 FR 63472), FDA identified the absorbable hemostatic agent and dressing as a transitional device that is a class III device that FDA previously regulated as a drug and for which premarket approval was immediately required. Since enactment of the 1976 amendments, FDA has approved numerous premarket approval (PMA) applications and PMA supplements authorizing the commercial distribution of new absorbable hemostatic agents and dressings in the United States.

Absorbable hemostatic products that include biological products or drug components are combination products as defined in 21 CFR 3.2(e). When the device component is responsible for the primary mode of action of the absorbable hemostatic product, it is assigned to CDRH for premarket review and regulation. If the absorbable hemostatic device is reclassified, these combination products will be subject to premarket notification [510(k)] requirements.

The current identification of the device states that an “absorbable hemostatic agent or dressing is a device intended to produce hemostasis by accelerating the clotting process of blood. It is absorbable.” Absorbable hemostatic devices are primarily applied during surgical procedures in order to control bleeding that is not readily controlled via conventional means, such as cautery or ligation. At other times, an absorbable hemostatic device may be applied due to the inaccessibility of a site to conventional hemostatic methods.

FDA is proposing the following device name and identification based on the agency's review to more accurately identify the device: An absorbable hemostatic device is an absorbable device that is placed in the body during surgery to produce hemostasis by accelerating the clotting process of blood.

At a July 8, 2002, public meeting of FDA's General and Plastic Surgery Devices Panel (the Panel), the Panel requested that the agency provide information on the potential content of a class II special controls guidance document for the absorbable hemostatic device. The Panel requested this information to enable them to make an appropriate recommendation on possible reclassification of the device (Ref. 1).

The notice of proposed rulemaking and notice of public hearing (REG-124152-06) that is the subject of these corrections are under sections 901 and 903 of the Internal Revenue Code.

As published, the notice of proposed rulemaking and notice of public hearing (REG-124152-06) contains errors that may prove to be misleading and are in need of clarification.

Accordingly, the notice of proposed rulemaking and notice of public hearing (REG-124152-06) that was the subject of FR Doc. E6-12358 is corrected as follows:

Section 3(a) of the Veterans Claims Assistance Act of 2000 (VCAA), Public Law 106-475, 114 Stat. 2096, amended 38 U.S.C. 5103 to impose on VA a duty to provide certain notice to certain claimants applying for veterans' benefits. See 38 U.S.C. 5103(a). Under section 5103(a), upon receipt of a substantially complete application for benefits, VA must “notify the claimant and the claimant's representative, if any, of any information, and any medical or lay evidence, not previously provided to the Secretary that is necessary to substantiate the claim” (section 5103(a) notice). 38 U.S.C. 5103(a). VA implemented section 5103(a) in 38 CFR 3.159, which reflects section 5103(a)'s requirement that VA give the notice upon receipt of a substantially complete application. See 38 CFR 3.159(b)(1). In addition, VA defined “substantially complete application” for purposes of section 5103(a) notice. See 38 CFR 3.159(a)(3). The purpose of this rulemaking is, in part, to clarify when VA has no duty to give section 5103(a) notice.

Long before enactment of the VCAA, VA had defined “application” in 38 CFR 3.1(p). An “application” is “a formal or informal communication in writing requesting a determination of entitlement or evidencing a belief in entitlement, to a benefit.” 38 CFR 3.1(p). Because that definition pre-dated the VCAA, it is apparent that it was not issued in implementation of the VCAA. However, experience implementing section 5103(a) has disclosed a potential ambiguity in the regulations, which this rulemaking will clarify. That ambiguity is whether VA's receipt of a notice of disagreement (NOD) also triggers VA's duty to give section 5103(a) notice because the NOD can be viewed as satisfying the § 3.1(p) definition of “application.” We propose to clarify that it does not.

An NOD is the means by which a claimant initiates an appeal of a decision on a claim to the Board of Veterans' Appeals (Board). 38 U.S.C. 7105(a); 38 CFR 20.200. “A written communication from a claimant or his or her representative expressing dissatisfaction or disagreement with an adjudicative determination by the agency of original jurisdiction and a desire to contest the result will constitute [an NOD].” 38 CFR 20.201.

The ambiguity we propose to clarify is whether VA's receipt of an NOD triggers VA's duty to issue section 5103(a) notice. It appears from these regulatory definitions that a single written communication expressing disagreement with a decision of the agency of original jurisdiction could be viewed as constituting both an NOD under § 20.201 and an application under § 3.1(p). (If a single written communication contains language expressing disagreement with a decision of the agency of original jurisdiction as well as language raising a new claim for benefits, section 5103(a) notice would be required in response to the new claim for benefits.) Because the definition in § 3.1(p) is a holdover from before the VCAA and was not intended to govern when VA must give section 5103(a) notice, VA does not view it as dispositive of the question. Furthermore, section 5103(a) does not specify whether VA must issue section 5103(a) notice upon receipt of an NOD. For the reasons we explain below, VA believes that Congress did not intend to require section 5103(a) notice upon VA's receipt of an NOD.

1. Congress intended VA to give section 5103(a) notice at the beginning of the claim process, but an NOD is filed after VA has decided a claim.

VA's claim process begins with the filing of an application. 38 U.S.C. 5101(a); 38 CFR 3.151(a), 3.152(a); Hensley v. West, 212 F.3d 1255, 1259 (Fed. Cir. 2000) (discussing claims process before VCAA's enactment). As stated, upon VA's receipt of a complete or substantially complete application, VA provides section 5103(a) notice. The claimant has a year from the date the notice is sent to respond. 38 U.S.C. 5103(b)(1). As we will further discuss, VA may decide the claim within that one-year period, but if the claimant subsequently submits relevant evidence within that one-year period, VA must readjudicate the claim. 38 CFR 3.159(b)(1). After notice of a decision on a claim is sent to the claimant, the claimant has up to one year to file an NOD with that decision. 38 U.S.C. 7105(b)(1); 38 CFR 20.302. Following receipt of an NOD, unless VA can resolve the disagreement through development or review action, VA will issue a statement of the case. 38 U.S.C. 7105(d)(1); 38 CFR 19.26. To perfect the appeal, the appellant has to file a substantive appeal in response to the statement of the case. 38 U.S.C. 7105(a), (d)(3); 38 CFR 20.200, 20.302(b)(1). Following VA's receipt of a substantive appeal, the appeal is certified to the Board.

From the above description of the claim process, it is apparent that, typically, an application starts the claim process and an NOD starts the appeal process after VA has decided a claim. However, the legislative history of the VCAA indicates that Congress intended VA to issue section 5103(a) notice early in the claim process. See S. Rep. No. 106-397, at 22 (2000) (“The Committee bill, in summary, modifies the pertinent statutes to reinstate VA's traditional practice of assisting veterans at the beginning of the claims process.”). The VCAA's legislative history indicates that Congress intended the new law to improve the efficiency of the adjudication process and the process by which subsequent claims for rating increases or service connection for additional conditions are handled, by ensuring proper development of the record when the claimant first submits an application for benefits. 146 Cong. Rec. S9211, S9212 (daily ed. Sept. 25, 2000) (statement of Sen. Rockefeller). The drafters wanted claimants to know early in the claim process what was necessary to substantiate their claims. Therefore, the VCAA was drafted to impose on VA the duty to issue section 5103(a) notice early in the claim process.

However, an NOD, which, as stated, is received in response to a decision on a claim and begins the appeal process for a decision on a claim, may fall within the § 3.1(p) definition of claim/application. We find nothing in section 5103(a)'s language or in the legislative history indicating Congressional intent to require VA to give another section 5103(a) notice upon receipt of an NOD.

2. Congress requires VA to issue a statement of the case in response to an NOD, so additional section 5103(a) notice would be redundant.

Upon receipt of an NOD, applicable law requires VA to review and, if necessary, further develop the evidence on the claim for which an NOD was filed. If such development or review does not resolve the disagreement, VA is required to prepare a statement of the case. The statement of the case in effect provides the claimant and any representative with notice similar to the notice required by section 5103(a). A statement of the case must include a summary of the evidence in the case pertinent to the issue or issues with which disagreement has been expressed and a citation of pertinent laws and regulations that controlled the decision. It also must include a discussion of how these laws and regulations affected the decision on the claim and a summary of the reasons for the decision made on each claim. 38 U.S.C. 7105(d)(1); 38 CFR 19.29. A statement of the case notifies a claimant of the evidence that VA received from the claimant and from other sources, and explains why that evidence dictated the result on that claim. A statement of the case therefore informs a claimant of the evidence needed to substantiate a claim for benefits addressed in the NOD. The requirement to issue a statement of the case could be viewed as being largely superfluous if section 5103(a) were interpreted to require VA to also provide notice under this section upon receipt of an NOD.

3. Giving section 5103(a) notice at the appeal stage of the claim process results in logical inconsistencies in the claim process.

Furthermore, interpreting section 5103(a) to require notice upon receipt of an NOD could result in the VA claim decision becoming final while the claimant still has time to submit the information and evidence necessary to substantiate a claim for benefits addressed in the NOD. Section 5103(b) of title 38, United States Code, provides a claimant one year to submit information or evidence requested in VA's section 5103(a) notice; however, an appellant has sixty days from the date VA mails a statement of the case, or the remainder of the one-year period beginning on the date notification of the determination being appealed is mailed, whichever period ends later, to file a formal or substantive appeal. 38 U.S.C. 7105(d)(3); 38 CFR 20.302(b). Thus, if the claimant does not complete the appeal initiated by the NOD or the Board decides the appeal before one year has elapsed from the date VA gave notice, VA's claim decision could become final while there is still time remaining to submit information and evidence necessary to substantiate a claim for benefits addressed in the NOD. Congress could not have intended such a result in this circumstance.

4. Not requiring section 5103(a) notice upon VA's receipt of an NOD would be consistent with case law governing such notice.

Besides the reasons given above regarding the intent of Congress, developing case law also supports not requiring section 5103(a) notice upon VA's receipt of an NOD. In Pelegrini v. Principi, 18 Vet. App. 112, 120 (2004), the United States Court of Appeals for Veterans Claims (CAVC) concluded that VA must provide section 5103(a) notice to a claimant seeking service connection before an initial unfavorable RO decision is made on the claim. The Court of Appeals for the Federal Circuit has agreed. Mayfield v. Nicholson, 444 F.3d 1328, 1334 (Fed. Cir. 2006). In Dingess v. Nicholson, 19 Vet. App. 473, 489 (2006), the CAVC added that VA must provide section 5103(a) notice to a claimant on the initial-disability rating and effective-date elements of a claim before the initial adjudication on them. Requiring section 5103(a) notice upon VA's receipt of an NOD would not satisfy these requirements because notice given following receipt of an NOD necessarily implies notice given after VA had already decided the claim. Furthermore, because the law requires that VA address the initial disability-rating and effective-date elements of a claim in the notice it gives upon receipt of an application, requiring notice on such elements upon VA's receipt of an NOD would be redundant.

Therefore, for the reasons stated above, we propose to state in a new paragraph, § 3.159(b)(3), that VA does not have a duty to provide the section 5103(a) notice upon receipt of an NOD.

Additionally, we propose to state that the section 5103(a) notice duty does not arise when the claimant is not eligible for the claimed benefit as a matter of law. In such circumstances, for example, in a claim for nonservice-connected disability pension when the claimant has no wartime service, there is no additional information or evidence the claimant could provide or VA could obtain that could substantiate the claim. This regulation would be consistent with the intent of Congress expressed in 38 U.S.C. 5103A(a)(2), which provides that “[t]he Secretary is not required to provide assistance to a claimant under this section if no reasonable possibility exists that such assistance would aid in substantiating the claim.”

The legislative history of sections 5103(a) and 5103A(a) supports a conclusion that VA action under section 5103(a) is not required if there is no relevant information or evidence to obtain because the claim is barred as a matter of law. The House Committee on Veterans' Affairs' report on legislation that became the VCAA stated with regard to the provision that became 38 U.S.C. 5103A(a):

Our analysis is also supported by the case law of the CAVC. In Mason v. Principi, 16 Vet. App. 129, 132 (2002), the CAVC rejected the claimant's contention that service during the 1980 Iran hostage situation constitutes wartime service for purposes of nonservice-connected disability pension pursuant to 38 U.S.C. 1521. The CAVC noted that there was no dispute as to the facts concerning the claimant's service and held that the claimant did not serve on active duty during a “period of war” as defined by 38 U.S.C. 101(11). Id. The CAVC further held that the VCAA was not applicable to the claim because the statute, and not the evidence, was dispositive of the claim. Id. ; see also Smith v. Gober, 14 Vet. App. 227, 231-32 (2000) (VCAA does not affect issue of whether interest on past due benefits is payable pursuant to Federal statutes), aff'd, 281 F.3d 1384 (Fed. Cir. 2002); Valiao v. Principi, 17 Vet. App. 229, 232 (2003) (“[w]here the facts averred by a claimant cannot conceivably result in any disposition of the appeal other than affirmance of the Board decision, the case should not be remanded for development [under the VCAA] that could not possibly change the outcome of the decision”). Thus, if a claim cannot be granted because, under undisputed facts, the claimant as a matter of law is not entitled to the benefit sought, it is reasonable to conclude that no section 5103(a) notice to the claimant is required.

Therefore, VA proposes to state in § 3.159(b)(3) that no section 5103(a) notice duty arises “[w]hen, as a matter of law, entitlement to the benefit claimed cannot be established, including, but not limited to, when the claimant is ineligible for the benefit sought due to lack of qualifying service, lack of veteran status, or other lack of legal eligibility.”

In addition to revising § 3.159 to ensure that the regulation is clear for users and consistent with statutory requirements, we propose to amend 38 CFR 3.159(b)(1). First, we propose to remove the third sentence of current § 3.159(b)(1), which states that VA will request the claimant to provide any evidence in the claimant's possession that pertains to the claim. Section 3.159 generally implements the notice and development requirements of sections 5103(a) and 5103A. The three notice requirements in section 5103(a) are currently prescribed in § 3.159(b)(1) as follows: VA will notify the claimant (1) of the information and medical or lay evidence required to substantiate the claim, (2) of which information and evidence, if any, that the claimant is to provide to VA, and (3) of which information and evidence, if any, VA will attempt to obtain on behalf of the claimant. However, the third sentence of current § 3.159(b)(1) is not required by statute and is redundant of the three statutory requirements from the perspective of what the claimant needs to submit to support the claim. As such, it is unnecessary as part of the regulation.

In Paralyzed Veterans of America v. Secretary of Veterans Affairs, 345 F.3d 1334 (Fed. Cir. 2003), the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) addressed a specific challenge to the additional regulatory provision in § 3.159 that states that VA will request that the claimant provide any evidence in the claimant's possession that pertains to the claim. The Federal Circuit expressly agreed with VA's rationale that the additional provision merely assists “the claimant by inviting any additional evidence that might help substantiate the claim.” Id. at 1347. The Federal Circuit found that the additional provision was reasonable and “effectively aimed at ensuring that the claimant makes the best showing possible to support his or her claim.” Id. at 1348. However, the Federal Circuit stopped short of finding this “additional regulatory provision” to be necessary, especially in light of the other three requirements.

In Pelegrini v. Principi, 18 Vet. App. 112 (2004), although the content of the section 5103(a) notice was not expressly at issue, the CAVC commented that the regulatory provision stating that VA will request that the claimant provide any evidence in the claimant's possession that pertains to the claim “can be considered a fourth element of the requisite notice” under section 5103(a). Id. at 121. However, because a request that the claimant provide any evidence that pertains to the claim is redundant of the notice required by statute from the perspective of what the claimant needs to submit to support the claim, a claimant will not be prejudiced by deleting this regulatory provision. A claimant who receives a section 5103(a) notice containing the three statutory elements will have received the same information regarding what the claimant needs to submit to support the claim as the claimant would have received had the claimant received a letter containing the three statutory elements and an additional request that the claimant provide any evidence in the claimant's possession that pertains to the claim.

We wish to avoid the possibility that this regulatory provision, intended only to perpetuate VA's long-standing practice to invite a claimant to submit any evidence he or she wants VA to consider, may be misconstrued as a statutory requirement to include specific language in the notices parroting the sentence in the regulation. Therefore, we propose to delete the statement in current § 3.159(b)(1) that VA will also request that the claimant provide any evidence in the claimant's possession that pertains to the claim. To avoid the possibility of similar misunderstandings regarding the nature of this provision and to ensure consistency between the manual and regulatory provisions, we further propose to rescind the provision of paragraph I.1.B.3.b of the Veterans Benefits Administration Adjudication Procedures Manual M21-1MR (VBA Manual M21-1MR), which currently requires ROs to send a letter to the claimant in response to a substantially complete application that “asks the claimant to submit any evidence in his/her possession that pertains to the claim.”

Second, for ease of use, we propose to add at the end of the second sentence of current § 3.159(b)(1) the term “notice” in parentheses, to use as a term of art within § 3.159(b)(1). The first two sentences of § 3.159(b)(1) describe the content of the section 5103(a) notice, and rather than repeating the language describing the content of the notice in the rest of § 3.159(b)(1), we propose to use the term “notice” to refer to the notice described in the first two sentences of § 3.159(b)(1).

Third, we propose to remove the fourth sentence of current § 3.159(b)(1). This sentence states: “If VA does not receive the necessary information and evidence requested from the claimant within one year of the date of the notice, VA cannot pay or provide any benefits based on that application.” This provision implemented language from section 5103 that was repealed by the Veterans Benefits Act of 2003, Public Law 108-183, section 701(b), 117 Stat. 2670. To ensure consistency with current law and the intent of Congress, we propose to replace this sentence with the following: “The information and evidence that the claimant is informed that the claimant is to provide must be provided within one year of the date of the notice.”

Fourth, we propose to amend the fifth sentence of current § 3.159(b)(1), which states that VA may decide the claim if the claimant has not responded to the section 5103(a) notice within 30 days. We propose to provide 45 days as a reasonable period after which VA may decide a claim if no response to the section 5103(a) notice has been received. Therefore, we propose to change the 30-day period in § 3.159(b)(1) to a 45-day period. To ensure consistency between the manual and regulatory provisions, we further propose to rescind the provision of paragraph I.1.B.3.c of the VBA Manual M21-1MR, which currently advises ROs to “inform the claimant that if he/she does not respond to the request for information within 60 days, VA may decide the claim based on all the information and evidence in the file.” The 45-day period will provide a claimant with more time to respond to the section 5103(a) notice compared to the 30-day period in § 3.159(b)(1) and, at the same time, will allow VA to adjudicate the claim more expeditiously compared to the 60-day period in the manual provision. It is important to note that, regardless of whether VA decides a claim after the 45-day period, the claimant still has one year from the date of the section 5103(a) notice to submit the requested information and evidence.

Additionally, 38 U.S.C. 5103A(g), “Other assistance not precluded,” states, “Nothing in this section shall be construed as precluding the Secretary from providing such other assistance under subsection (a) to a claimant in substantiating a claim as the Secretary considers appropriate.” In accordance with section 5103A(g), VA promulgated § 3.159(c), obligating itself to give the assistance described in paragraphs (c)(1), (c)(2), and (c)(3) of § 3.159, relating to assistance with obtaining records, to an individual attempting to reopen a finally decided claim. See Duty to Assist, 66 FR 45,620, 45,628 (Aug. 29, 2001). In accordance with VA's intention to issue regulations when the Secretary deems it appropriate to provide the additional assistance in substantiating a claim contemplated in section 5103A(g), see id. at 45,629, we propose to add to § 3.159 a new paragraph (g), which states that the authority recognized in subsection (g) of 38 U.S.C. 5103A is reserved to the sole discretion of the Secretary and will be implemented, when deemed appropriate by the Secretary, through the promulgation of regulations. The main purpose of this provision is to avoid the potential disparate treatment of similarly situated claimants that could arise from inconsistent use in various parts of the agency of open-ended authority to provide “extra” development assistance. Also, this provision is consistent with the Secretary's determination, in the prior rulemaking for § 3.159, of the appropriate level of assistance to be provided individuals based on VA's finite resources and the need to process claims in an efficient manner for the benefit of all veterans.

Last, we propose to clarify another aspect of § 3.159 to state that a medical examination or medical opinion is not necessary to establish a nexus between a current disability and service when a claimant satisfies the chronicity or continuity requirements in 38 CFR 3.303(b). Section 3.303(b) states, in pertinent part, as follows: “With chronic disease shown as such in service (or within the presumptive period under § 3.307) so as to permit a finding of service connection, subsequent manifestations of the same chronic disease at any later date, however remote, are service connected, unless clearly attributable to intercurrent causes * * *. For the showing of chronic disease in service there is required a combination of manifestations sufficient to identify the disease entity, and sufficient observation to establish chronicity at the time, as distinguished from merely isolated findings or a diagnosis including the word `Chronic.' When the disease identity is established * * *, there is no requirement of evidentiary showing of continuity. Continuity of symptomatology is required only where the condition noted during service (or in the presumptive period) is not, in fact, shown to be chronic or where the diagnosis of chronicity may be legitimately questioned. When the fact of chronicity in service is not adequately supported, then a showing of continuity after discharge is required to support the claim.” If the chronicity or continuity requirements are met, there is no need for VA to provide a medical examination or medical opinion to determine whether there is a nexus between a veteran's current disability or death and some disease or symptoms during service. (Of course, a medical examination might be needed for some other reason, such as to determine the current level of disability in a claim for service connection.) We believe that it would be helpful to claimants, their representatives, and VA staff to explicitly state this within § 3.159(c)(4)(i), which covers medical examinations and medical opinions. We therefore propose to add the following sentence after the first sentence in § 3.159(c)(4)(i): “A medical examination or medical opinion is not necessary to show a link between a veteran's current disability or death and some disease or symptoms during service when the evidence of record already satisfies the chronicity or continuity requirements in § 3.303(b).”

This document contains no provisions constituting a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).

The Secretary hereby certifies that this regulatory amendment will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. Only VA beneficiaries could be directly affected. Therefore, pursuant to 5 U.S.C. 605(b), this amendment is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.

Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Order classifies a rule as a significant regulatory action requiring review by the Office of Management and Budget if it meets any one of a number of specified conditions, including: Having an annual effect on the economy of $100 million or more; creating a serious inconsistency or interfering with an action of another agency; materially altering the budgetary impact of entitlements or the rights of entitlement recipients; or raising novel legal or policy issues. VA has examined the economic, legal, and policy implications of this proposed rule and has concluded that it is a significant regulatory action because it raises novel legal or policy issues.

The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any year. This proposed rule would have no such effect on State, local, and tribal governments, or on the private sector.

The Catalog of Federal Domestic Assistance program numbers and titles for this proposal are 64.100, Automobiles and Adaptive Equipment for Certain Disabled Veterans and Members of the Armed Forces; 64.101, Burial Expenses Allowance for Veterans; 64.102, Compensation for Service-Connected Deaths for Veterans' Dependents; 64.103, Life Insurance for Veterans; 64.104, Pension for Non-Service-Connected Disability for Veterans; 64.105, Pension to Veterans Surviving Spouses, and Children; 64.106, Specially Adapted Housing for Disabled Veterans; 64.109, Veterans Compensation for Service-Connected Disability; 64.110, Veterans Dependency and Indemnity Compensation for Service-Connected Death; 64.114, Veterans Housing—Guaranteed and Insured Loans; 64.115, Veterans Information and Assistance; 64.116,Vocational Rehabilitation for Disabled Veterans; 64.117, Survivors and Dependents Educational Assistance; 64.118, Veterans Housing—Direct Loans for Certain Disabled Veterans; 64.119, Veterans Housing—Manufactured Home Loans; 64.120, Post-Vietnam Era Veterans' Educational Assistance; 64.124, All-Volunteer Force Educational Assistance; 64.125, Vocational and Educational Counseling for Servicemembers and Veterans; 64.126, Native American Veteran Direct Loan Program; 64.127, Monthly Allowance for Children of Vietnam Veterans Born with Spina Bifida; and 64.128, Vocational Training and Rehabilitation for Vietnam Veterans' Children with Spina Bifida or Other Covered Birth Defects.

For the reasons set out in the preamble, VA proposes to amend 38 CFR part 3 (subpart A) as follows:

In the Final Rules section of this Federal Register , EPA is approving the State's SIP submittal as a direct final rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If no adverse comments are received in response to this rule, no further activity is contemplated. If EPA receives adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment. For additional information, see the direct final rule which is located in the Rules section of this Federal Register .

This proposal addresses the approval of local AVAQMD Rule 442. In the Rules and Regulations section of this Federal Register , we are approving this local rule in a direct final action without prior proposal because we believe this SIP revision is not controversial. If we receive adverse comments, however, we will publish a timely withdrawal of the direct final rule and address the comments in subsequent action based on this proposed rule. We do not plan to open a second comment period, so anyone interested in commenting should do so at this time. If we do not receive adverse comments, no further activity is planned. For further information, please see the direct final action.

Table of Contents I. Background II. Information Submissions Before and After the EWR Rule Became Effective A. Pre-TREAD Act Transmissions of Information to NHTSA B. The Early Warning Reporting Requirements C. Manufacturer Submissions of EWR Information III. The Proposed Rule on the Confidentiality of EWR Information A. Class Determinations Based on FOIA Exemption 4 1. Basis for Exemptions 2. Proposed Class Determinations on the Confidentiality of EWR Data a. Production Numbers b. Consumer Complaints c. Warranty Claims d. Field Reports e. Common Green Tire Identifiers f. Other Issues To Be Considered B. EWR Class Determination Based on FOIA Exemption 6 IV. Exemption 3 V. Other EWR Data VI. Identifying Confidential Information Located in Electronic Files VII. Request for Comments VIII. Privacy Act Statement IX. Regulatory Analyses and Notices A. Executive Order 12866 and DOT Regulatory Policies and Procedures B. Regulatory Flexibility Act C. National Environmental Policy Act D. Executive Order 13132 (Federalism) E. Unfunded Mandate Reform Act F. Executive Order 12988 (Civil Justice Reform) G. Paperwork Reduction Act H. Executive Order 13045 I. Regulation Identifier Number (RIN) I. Background

In 1966, the Congress enacted the National Traffic and Motor Vehicle Safety Act (Safety Act), for the purpose of reducing traffic accidents and deaths and injuries to persons resulting from traffic accidents. 49 U.S.C. 30101. 1 Since it was amended in 1974, 2 the Safety Act has contained a series of provisions that address motor vehicles and motor vehicle equipment that contain a potential or actual defect that is related to motor vehicle safety.

First, the Act requires a manufacturer to notify NHTSA and the vehicle or equipment owners if it learns of a defect and decides in good faith that the defect is related to motor vehicle safety. 49 U.S.C. 30118(c). This duty is independent of any action by NHTSA. 3 Ordinarily, a manufacturer's notice is followed by the manufacturer's provision of a free remedy to owners of defective vehicles and equipment. See 49 U.S.C. 30120. Collectively, the manufacturer's notice and remedy are known as a recall.

Second, Congress provided NHTSA with considerable investigative and enforcement authority. The Safety Act authorizes NHTSA to conduct investigations and to require manufacturers to submit reports to enable the agency to determine compliance with the statute. 49 U.S.C. 30166(b), (e). In addition, NHTSA may initiate administrative enforcement proceedings to decide whether a motor vehicle or motor vehicle equipment contains a safety-related defect or does not comply with applicable standards. An investigation may culminate in NHTSA's order to the manufacturer to provide notification of a safety-related defect or a noncompliance to owners of the vehicle or equipment. 49 U.S.C. 30118(a)-(b).

As a practical matter, if a manufacturer has not submitted a notice of a safety-related defect to NHTSA and if the agency has not received information that provides a sufficient basis for the opening of an investigation, it has been unlikely that NHTSA would investigate a potential problem. This practical limitation on NHTSA's investigations manifested itself in 2000. Under the limited level of reporting then required, the agency lacked sufficient information to identify defects in Firestone tires mounted on Ford Explorers. 4 Numerous fatalities occurred before NHTSA opened an investigation and Firestone conducted recalls.

On November 1, 2000, Congress enacted the Transportation Recall Enhancement, Accountability, and Documentation (TREAD) Act. Pub. L. No. 106-414, 114 Stat. 1800. The TREAD Act added provisions to the Safety Act that expanded the scope of the information manufacturers submit to NHTSA prior to a manufacturer-initiated recall. In relevant part, the TREAD Act required the Secretary of Transportation to publish a rule setting out the early warning reporting (EWR) requirements to enhance the agency's ability to carry out the Act. 49 U.S.C. 30166(m). In general, the TREAD Act authorized the agency to require manufacturers to submit information that may assist in the early identification of defects related to motor vehicle safety. Id.

In July 2002, NHTSA promulgated the EWR rule. 67 FR 45822 (July 10, 2002). 5 Generally, the EWR rule required certain manufacturers of motor vehicles ( e.g. , automobiles and other light vehicles, trucks, buses, motorcycles, and trailers) and motor vehicle equipment ( e.g. , tires and child restraints) to submit data regarding production numbers (cumulative total vehicles or equipment manufactured annually), incidents involving death or injury based on claims and notices, property damage claims, consumer complaints, warranty claims paid, and field reports (collectively “early warning data”) on a quarterly basis. See 49 CFR 579.21-26. The information is submitted electronically to the agency in a standardized format. 6

The EWR rule did not address the confidentiality of EWR data, but noted that this issue would be considered as part of the proposed amendments to NHTSA's confidential business information rule. See 67 FR at 45866, n.6. The agency addressed the confidentiality of EWR data in its July 2003 final rule on Confidential Business Information (CBI) rule. 49 CFR part 512, 68 FR 44209 (July 28, 2003). In addition to establishing revised general requirements governing claims of confidentiality and NHTSA rulings on these claims, the CBI rule addressed the confidentiality of EWR data. The CBI rule established a new Appendix C setting forth class determinations treating EWR information on production numbers (excluding light vehicles), consumer complaints, warranty claims, and field reports as confidential. 49 CFR part 512 App. C. Other EWR data were not specifically covered by the CBI rule. The agency based these class determinations on the substantial competitive harm and impairment standards of Freedom of Information Act (FOIA) Exemption 4. See 5 U.S.C. 552(b)(4); 49 CFR part 512 App. C.

In April 2004, NHTSA responded to petitions for reconsideration of the July 2003 CBI rule. 69 FR 21409 (April 21, 2004). The agency amended the rule by adding two class determinations to Appendix C based on FOIA Exemptions 4 and 6. One class determination, based on Exemption 4, covered common green tire identifiers submitted by tire manufacturers under 49 CFR 579.26(d). 7 The Exemption 6 class determination covered the last six (6) characters of vehicle identification numbers (VINs) contained in EWR death and injury reports submitted to NHTSA. See e.g. , 49 CFR 579.21(b)(2).

Public Citizen challenged the legality of Appendix C to 49 CFR part 512. In a March 31, 2006 decision, the United States District Court for the District of Columbia ruled that NHTSA had the authority to promulgate the rule making categorical confidentiality determinations for classes of EWR data. Public Citizen, Inc. v. Mineta, 427 F. Supp. 2d 7, 12-14 (D.D.C. 2006). The District Court also concluded, however, that NHTSA had not provided adequate notice and opportunity to comment on those determinations at the time of the proposed rule, id . at 14-17. The Court remanded the matter to NHTSA but did not address the parties' other claims. Id. Thereafter, intervenor Rubber Manufacturers Association (RMA) filed a motion to amend the judgment to address its claim that the disclosure of EWR data was precluded by a specific disclosure provision in the TREAD Act, 49 U.S.C. 30166(m)(4)(C). 8 RMA asserted that this provision met the requirements of FOIA Exemption 3, which allows the withholding of information prohibited from disclosure by another statute. 5 U.S.C. 552(b)(3).

In a supplemental memorandum opinion filed on July 31, 2006, the Court accepted RMA's argument that it should consider the Exemption 3 claim, but held that the TREAD Act's disclosure provision was not an Exemption 3 statute. See Public Citizen, Inc. v. Mineta, 444 F. Supp. 2d 12 (D.D.C. 2006). On August 24, 2006, RMA filed a motion seeking either a judgment under Federal Rule of Civil Procedure 54(b) or certification of interlocutory appeal under 28 U.S.C. 1292(b) of the District Court's decision regarding Exemption 3. On September 5, 2006, the District Court granted RMA's motion. On September 28, 2006, RMA filed a Notice of Appeal of the Judgment of July 31, 2006 and associated orders.

In light of the District Court's decisions, NHTSA is proposing a rule to address the confidentiality of EWR information through specific class determinations based on FOIA Exemptions 4 and 6. Our proposal, which sets forth determinations largely similar to our prior determinations, addresses the District Court's notice and comment concerns.

Prior to the enactment of the TREAD Act, NHTSA received information on potential and actual safety-related defects in motor vehicles through several primary mechanisms. First, vehicle owners submitted complaints (also known as vehicle owner questionnaires (VOQs))  9 to NHTSA's Office of Defects Investigation (ODI). These complaints tended to identify problems consumers had experienced in their vehicles. Second, manufacturers provided copies of technical service bulletins and other communications transmitted to more than one manufacturer, dealer or owner. See 49 U.S.C. 30166(f); 49 CFR 579.5 (2002-2005), 573.8 (1995-2001). Third, manufacturers submitted information to the agency during investigations of particular vehicles and equipment (such as tires) undertaken by ODI. Finally, manufacturers submitted reports that certain motor vehicles and equipment contained safety-related defects pursuant to 49 CFR part 573 (Defect and Non-Compliance Responsibility and Reports) after determining that such a defect exists. See 49 U.S.C. 30118(c).

On average, during the five years preceding the TREAD Act, ODI conducted approximately 83 investigations of potential safety related defects per year. On average, 64 of these were first stage investigations known as Preliminary Evaluations (PEs). The remaining ones were second-stage investigations—Engineering Analyses (EAs).

During the five (5) years following enactment of the TREAD Act, these numbers have remained roughly the same, with the agency conducting approximately 84 investigations annually (66 PEs, 28 EAs). In most of these investigations, ODI issued information requests to manufacturers. A review of the submissions received from manufacturers over a recent one-year period revealed that nearly every PE or EA submission to the agency involved a request for confidential treatment. 10

The TREAD Act dramatically changed the nature and amount of information manufacturers submit to NHTSA. The EWR rule requires specified manufacturers to submit a broad array of information on each make and model of vehicle and child seat, and substantial tire line that they manufacture. The EWR requirements apply mainly to larger manufacturers of motor vehicles and tires, and all manufacturers of child restraint systems ( see 49 CFR part 579). In general, vehicle manufacturers who annually produce 500 or more vehicles in a category must submit quarterly reports with regard to the following categories of vehicles: light vehicles, medium-heavy vehicles and buses, trailers, and motorcycles. The reporting information required of these manufacturers is summarized below:

EWR reporting was phased-in, with the first quarterly EWR reports submitted on or about December 1, 2003. Field reports (copies of non-dealer reports) were first submitted on or about July 1, 2004. 68 FR 35145, 35148 (June 11, 2003) (specifying deadline submissions for EWR reports). Since the EWR rule's data submission requirements began in December 2003, manufacturers have submitted large amounts of information. Over 500 manufacturers have regularly submitted reports and collectively submitted thousands of reports, making the volume of the incoming data extensive. NHTSA has received reports on more than 8 million consumer complaints, 138 million warranty claims, and nearly 5 million field reports (all aggregated) from light vehicle manufacturers. Other manufacturers have also provided a large volume of aggregated data for the agency to analyze: heavy and medium bus manufacturers—over 246,000 consumer complaints, nearly 7 million warranty claims, and nearly 245,000 field reports; trailer manufacturers—nearly 66,000 consumer complaints, over 1.2 million warranty claims, and over 18,000 field reports; motorcycle manufacturers—over 35,000 consumer complaints, over 687,000 warranty claims, and over 91,000 field reports; tire manufacturers—over 1 million warranty claims; and child restraint manufacturers—nearly 43,000 warranty claims and over 7,000 field reports.

In view of the Court's decision in Public Citizen, Inc. v. Mineta, NHTSA is initiating a new rulemaking proceeding and proposing to adopt class determinations that address the confidential treatment of certain EWR information. In general, NHTSA is proposing to adopt the class determinations promulgated in 2003 and 2004. 11 The new class determinations we are proposing for EWR data are based on FOIA Exemption 4 and would be set out in a new Appendix C to 49 CFR part 512, which would read as follows:

Consistent with our prior approach, the agency proposes creating categories based on Exemption 4 of the FOIA, 5 U.S.C. 552(b)(4). Under Exemption 4, the standard for assessing the confidentiality of required submissions of information is whether disclosure is likely either to cause substantial competitive harm to the originating entity or to impair the government's ability to obtain necessary information in the future. National Parks & Conservation Ass'n v. Morton, 498 F.2d 765, 770 (D.C. Cir. 1974). Meeting the competitive harm standard requires that there be “actual competition and a likelihood of substantial competitive injury” from disclosure of the information. CNA v. Donovan, 830 F.2d 1132, 1152 (D.C. Cir. 1987). Assessing the effect of disclosure under the impairment prong requires a “rough balancing” of the extent of impairment and the information's importance against the public's interest in disclosure. Washington Post v. Dep't of Health and Human Services, 690 F.2d 252, 269 (D.C. Cir. 1982).

We note that motor vehicle and motor vehicle equipment manufacturers who are required to submit EWR data operate in a highly competitive business environment. See http://stats.bls.gov/oco/cg/cgs012.htm (generally describing the nature of the motor vehicle and parts industry). In light of the highly competitive environment in which these manufacturers operate, the comprehensive EWR data that they submit possess commercial value to the submitting manufacturers, competitors, and others such as suppliers who are interested in these types of data. These data are standardized and, as discussed above, the EWR reports contain identical informational elements for each regulated manufacturer category under the EWR rule. See 49 CFR part 579 subpart C. These reports are submitted pursuant to standardized electronic reporting templates that are used repeatedly from reporting period to reporting period. Each manufacturer in a regulatory category reports on the same systems and components and provides a snapshot of that manufacturer's experience for each of the standard informational elements.

Further, as we explain below, under the TREAD Act, manufacturers need only produce that information which they already collect. In light of this fact, on balance, the disclosure of certain categories of EWR information (consumer complaints, warranty claims, and field reports) is more likely to cause manufacturers to scale back their collection efforts, which would impair the agency's ability to obtain EWR data in future submissions, than if the information were not disclosed. Without the collection of comprehensive data by manufacturers, the effectiveness of the EWR program would be adversely impacted.

Additionally, as reflected by the number of EWR submissions when compared to the number of confidentiality requests that manufacturers submit to the agency in the course of defect investigations noted above, if NHTSA were to attempt to process individualized requests for confidentiality of individual EWR submissions, the agency would be overwhelmed. A huge backlog would develop and grow. During the time that NHTSA was processing these requests for confidentiality, nothing would be released. The situation would be similar to the substantial FOIA request backlog experienced at some agencies. Moreover, submissions would not be released until the individual processing was completed. The net effect would be to hamper agency efforts to address these claims for confidential treatment expeditiously and likely divert resources from other efforts, including pursuing other enforcement activities. The District Court recognized this possibility when it ruled that categorical rules that address the confidentiality of EWR data are necessary “to allow the agency to administer the EWR program effectively,” Public Citizen, 427 F. Supp. 2d at 13, and that the agency was “justified in making categorical rules to manage the tasks assigned to it by Congress under the TREAD Act.” Id.

In the recent Public Citizen case, the parties submitted briefs on NHTSA's authority to issue categorical determinations. The court accepted NHTSA's position that the agency had the authority to do so. Id.

Based on NHTSA's authority, as recently confirmed in the District Court's decision, to make categorical class determinations, we are proposing to create such classes based on Exemption 4 for the EWR data categories listed below.

The EWR rule requires certain manufacturers to submit the number of vehicles, tires and child restraint systems, by make, model, and model (or production) year, produced during the model year of the reporting period and the prior nine model years (prior four years for child restraint systems and tires). See 49 CFR 579.21-26.

Production figures for models of motor vehicles, other than light vehicles, and for tires and child restraints are not publicly available. 12 As noted above, NHTSA proposes to include EWR production figures, other than for light vehicles, in a class determination of confidentiality based on the competitive harm prong of National Parks. EWR production data reveal a variety of valuable information, including a company's production capacity, the sales and market performance of its individual products, 13 and the success of its marketing strategies. This market-related information would be valuable to the reporting manufacturer's competitors, who commonly want to know how well products sell, including how well their competitors' products have been and are selling. The competitors would use the production information in their own product planning and marketing. For example, the release of this EWR production information would likely have the following impacts: (1) Medium-heavy vehicle manufacturers would use a rival's production information to monitor the competitor's production capacity (which would reveal that competitor's capacity to manufacture certain products) and, separately, suppliers would use the information to gain a competitive advantage over a submitter during pricing negotiations, in instances such as when they could determine that they are the sole supplier; (2) bus manufacturers would use production information to chart the overall market and the strengths and weaknesses of the reporting entity's business within specific makes and models; (3) because product plans are based upon an evolution of production direction and experience, disclosure of motorcycle production information would expose manufacturers' future plans to competitors; (4) child restraint manufacturers would use production data to assess their competitors' production capabilities, sales and market performance through means otherwise unavailable without considerable market research expense; and (5) the disclosure of tire production numbers by brand and size would result in competitive harm to the manufacturers by revealing specific and critical information about those companies' sales and marketing strategies. We note that in the context of individual investigations, the agency has generally granted confidential treatment to production data on child restraints and tires submitted to NHTSA but released past light vehicle production numbers, which, as noted above, are generally available to the public and have generally not been granted confidential status.

The EWR rule requires larger volume vehicle manufacturers and all child restraint manufacturers to submit the number of consumer complaints received broken out, for each make and model, by specific categories such as system component, fire and rollover—all of which are binned by code. 49 CFR 579.4, 579.21-26. Consumer complaints are defined by the regulation as:

NHTSA proposes to include EWR consumer complaint data in a class determination of confidentiality based on both the competitive harm and impairment prongs of National Parks . The commercial value of consumer complaint data is well-recognized. Complaint data are a valuable data source used by companies to help them identify areas of concern, including product performance, to consumers and provide guidance on where to allocate their limited resources. 15 The disclosure of EWR complaint numbers would provide competitors with aggregated data on the performance of entire product lines and key, individual systems and/or components. In view of the competitive value of these data, NHTSA has tentatively concluded that the release of EWR consumer complaint data would cause substantial harm to the competitive position of the manufacturer that collected and reported them.

Companies may receive customer input and feedback on product performance in a variety of ways and establish differing practices for the receipt of customer complaints, which are taken into account by the definition of consumer complaint. To obtain these data, companies may, for example, increase the staff available at their toll-free telephone numbers or create web-based systems through which consumers can make complaints instantly by electronic mail. More consumer input channels increase the robustness of the available data. In addition to providing valuable information to the company, consumer complaints provide feedback on product performance that can be valuable to NHTSA in identifying problems, including potential defects that may point to the presence (or absence) of a safety problem. The agency seeks to ensure that it receives as much information as possible to identify possible defect trends.

Under the early warning reporting provisions of the Safety Act, however, NHTSA may not require a manufacturer of a motor vehicle or motor vehicle equipment to maintain or submit records respecting information not in the possession of the manufacturer. 49 U.S.C. 30166(m)(4)(B). In other words, NHTSA may require manufacturers to submit reports based on information that they have collected but may not require manufacturers to collect information not otherwise collected.

In view of the fact that the quantity and comprehensiveness of the EWR consumer complaint data depend in substantial part on the willingness of manufacturers to collect this information through a broad and multi-input approach, NHTSA does not want to take steps that discourage the collection efforts. NHTSA is concerned that the routine disclosure of EWR consumer complaint information would discourage these efforts, and ultimately reduce the amount of information manufacturers collect. This would impair our ability to obtain this information in the future for analysis. It would adversely impact not only the EWR program as a whole, but a reduction in complaint data would also significantly impact individual investigations in which ODI routinely considers and follows up on such data. The disclosure of these data, however, would be of limited value to the public. Complaint data frequently involves issues that are not safety-related. On balance, the importance of the information to the agency's ability to help it identify potential safety defects and the associated impairment outweigh the smaller interest in its public disclosure. Thus, the agency proposes to withhold these data under Exemption 4.

Under the EWR rule, manufacturers of more than 500 vehicles per year and tire manufacturers must report warranty claims (warranty adjustments for tire manufacturers) they paid for specified components and systems broken down by component, make, model and model year. 49 CFR 579.21-26. Repairs made outside of warranties that are covered by “good will” are also reported under warranty claims and warranty adjustments. 16 49 CFR 579.4. Manufacturers of child restraint systems must combine these data with the number of reportable consumer complaints. The warranty information is reported on a detailed make/model basis and categorized with reference to the twenty-two categories defined in the EWR regulation.

NHTSA proposes to include EWR warranty data in a class determination of confidentiality based on both the competitive harm and impairment prongs of National Parks . Warranty claims data generally reflect a repair paid for by a manufacturer under a warranty. The commercial value of warranty complaint data is well known. Warranty data are a valuable data source used by companies in identifying problem trends early in the life of a vehicle or equipment, before the expiration of the warranty. The EWR warranty data provide comprehensive, competitively valuable information about the field experience of components and systems across all makes and models. Many components and systems are updated over time to incorporate new technologies or to achieve cost savings. They may be provided by different suppliers. The manufacturer's warranty experience with various components and systems is a valuable dataset. 17 The disclosure of EWR warranty numbers would provide competitors with aggregated data on the performance of entire product lines and key, individual systems and/or components. Competitors would use this information to assess the in-use performance of parts and systems. It would be used in purchasing, pricing, and sourcing decisions, all of which would be likely to have competitive impacts. Accordingly, NHTSA has tentatively concluded that the release of the EWR warranty data would cause substantial harm to the competitive position of the manufacturer that collected and reported them.

Warranties vary in length ( e.g. , years, miles) and scope ( e.g. , 3 years/36,000 miles vs. 4 years/50,000 miles). Other things being equal, we believe that companies with more generous warranty and good will programs will have a higher number of warranty claims than those with more limited policies. The more generous the warranty policies (such as longer warranty coverage), the more warranty data that will be subject to disclosure to NHTSA.

Because of the data's commercial value and the manner in which they can be used, the disclosure of this information would reduce the willingness of manufacturers to maintain extensive warranty programs including extended warranties and good will, which could ultimately reduce the availability of robust warranty information in the future. ODI would have substantially less information to analyze in investigating potential defects. 18 Also consumers would receive fewer free repairs under warranty programs, which in addition to being economically disadvantageous, would in some instances adversely affect motor vehicle safety because vehicles would not be repaired. However, the EWR information would not be useful to the public in comparing vehicles or equipment because of the differences in warranty terms and corporate warranty practices—which would could cause the public to derive incorrect conclusions from the information. The rough balancing under the impairment prong weighs in favor of withholding this information, as the public interest favoring disclosure is small and the adverse effects accompanying disclosure are substantial. Thus, the agency proposes to withhold EWR warranty information under Exemption 4.

Field reports are communications from a manufacturer's representative or dealer about a malfunction or performance problem. 49 CFR 579.4. The EWR rule requires manufacturers of specified vehicles and child restraints to provide information on field reports and copies of non-dealer field reports. In general, as in other categories of EWR data, the field report data are provided by make, model and model year and, further, by numerous specified systems and components. 49 CFR 579.21-25.

Field reports reflect the in-use experience of a manufacturer's product, collected by the company at its expense and with the intent of identifying problems with its products. The nature, quality and quantity of field reports vary, with reports from some companies reflecting their pursuit of detailed feedback, and those from others yielding less information. For others, a field report is more akin to a technical investigation into a problem detected through warranty, consumer complaint or other information available to the company.

NHTSA proposes to include EWR field report information in a class determination of confidentiality based on both the competitive harm and impairment prongs of National Parks . Field report information would identify systems and components that have experienced malfunction or performance issues, in quantitative terms in all products. More particularly, the field reports would reveal specific problems associated with particular components and systems. Overall, the information would reveal aspects of a vehicle's performance (whether potentially safety-related or not) that a manufacturer deems important in its commercial efforts. If EWR field report information were disclosed, the reporting manufacturer's competitors would have access to comprehensive data involving malfunction or performance issues covering all products. Such information, if publicly released, would be of substantial value to competitors, who could avert similar issues or improve their products without the need to invest in market research, engineering development, or actual market experience. NHTSA has tentatively concluded that their release would cause substantial harm to the competitive position of the manufacturer that collected and reported them.

Manufacturers' decisions to obtain field reports are discretionary and practices vary among manufacturers. The disclosure of field report data would discourage manufacturers from initiating field reports. This would lead to fewer and less reliable field reports available to the agency in the future to identify potential safety defects promptly. Field reports are particularly valuable in identifying areas of potential concern to manufacturers. Some of these reports have also been indicative of potential defect trends. Since the agency can require only that manufacturers submit information about, and copies of, those field reports that companies choose to prepare and/or obtain, there is a substantial risk that the agency's ability to obtain this information in the future would be impaired, which would adversely affect the program's effectiveness. See 49 U.S.C. 30166(m)(4)(B). By contrast, the value of these data would be limited to the public. The technical data and reports of the number of field reports would not readily identify safety-related issues. As such, the agency does not believe that these data and numbers would contain information that would be informative to the public with regard to vehicle safety. In balancing the interests in disclosure, the agency has tentatively concluded that the impacts to the agency's ability to identify safety defects from these technically-rich reports—as well as the competitive impacts to submitters—outweigh the interest the public has in disclosure of this information. Consequently, the agency proposes to withhold this information under Exemption 4.

The EWR rule requires certain tire manufacturers to provide a list of common green tire data. 49 CFR § 579.26(d). “Common greens” are tires “that are produced to the same internal specifications but that have, or may have, different external characteristics and may be sold under different tire line names.” 49 CFR 579.4(c). NHTSA proposes to include EWR common green tire data in a class determination of confidentiality based on the competitive harm prong of National Parks . The common green tire information reveals the identities of tires that share the same internal specifications and relationships between manufacturers and private brand name owners. Tire manufacturers previously indicated that these data are particularly valuable because they permit competitors to assess individual manufacturer capabilities and marketing strategies. 69 FR at 21417.

In addition to comments on the above, we seek comments on the proposed approach. This includes whether the proposed categories for certain EWR data ( i.e. , those data covering non-light vehicle production, consumer complaints, warranty claims, field reports, and common green tires) should be held confidential by class determinations based on Exemption 4. For example, we invite commenters to provide information relating to whether the release of this information would provide competitors with valuable information relating to the business of the reporting entity, such as marketing, performance problems and/or costs, to the extent that the disclosure would cause or be likely to cause the data submitter substantial competitive harm. We are also interested in whether the disclosure of the information covered by our proposed classes would significantly discourage manufacturers from continuing to obtain and manage this information as they do now.

Commenters may also address different approaches. We invite comments that address the practical concerns of such potential approaches. For example, if NHTSA were to adopt presumptive class determinations for each of the EWR data categories, what are the relative merits of each proposed class within the context of the large volume of information generated by EWR requirements, and the manner in which the agency can address the confidentiality of these materials in an efficient and consistent manner. 19

Commenters should also, where appropriate, indicate and demonstrate how the restrictions imposed by Congress in 49 U.S.C. 30166(m)(4)(B) would affect the agency's ability to continue collecting EWR data if they are subject to routine disclosure. Supporting facts in favor or against each class should be included as appropriate.

NHTSA receives VIN information under the EWR rule in reports on incidents involving deaths and injuries. See e.g. 49 CFR 579.21(b)(2). NHTSA is proposing to create a class determination that would apply to the last six (6) characters of the unique seventeen (17) character vehicle identification number (VIN) contained in EWR death and injury reports. This proposal is grounded on Exemption 6 of the FOIA, which protects information that would result in a clearly unwarranted invasion of privacy if disclosed. See 5 U.S.C. 552(b)(6). See also Center for Auto Safety v. NHTSA , 809 F. Supp. 148 (D.D.C. 1993).

Factually, this proposed exemption is based on the risk that the disclosure of a full VIN could enable an individual to discern personal information involving a vehicle owner that could result in an unwarranted invasion of his or her privacy. With respect to EWR submissions, NHTSA had previously issued a determination that the last six (6) characters in the seventeen-character VIN should be protected, as a class, from public disclosure under FOIA Exemption 6, 5 U.S.C. 552(b)(6). 69 FR at 21416. When coupled with publicly-available data bases, the disclosure of a complete VIN can lead to the discovery of personal information (e.g., name and address) about the owner of a vehicle associated with a death or injury. 20 The first 11 characters of the VIN reveal the make, model, model year, and engine of the vehicle, but the last six identify the specific vehicle. We are concerned that release of VINs where there has been a death or an injury reported under the EWR program would result in communications and inquiries from third parties that would invade personal privacy.

Since the public can still determine a vehicle's make and model using the first 11 characters of the VIN, which would be released, members of the public with an interest in motor vehicle safety can still ascertain whether a particular type of vehicle may be involved in a potential vehicle safety issue. As discussed above, however, the revelation of the complete VIN is accompanied by the risk of an invasion of privacy. On balance, the agency tentatively believes that that interest in protecting the risk of invading individuals' privacy outweighs the public's interest in this information and the agency has tentatively concluded that this information merits withholding under FOIA Exemption 6. 21

This new class determination would be set out in a new Appendix D, which would read as follows:

This proposal would apply as a rule to only those VINs that are provided in EWR submissions and would not apply as a rule to the agency's treatment of VINs in other instances.

We seek comment on the appropriateness of our proposal, as well as variations on this proposal related to the confidentiality of all or parts of VINs.

In its comments in the course of the earlier EWR CBI rulemaking, and the memoranda it filed with the District Court in the Public Citizen case, the RMA asserted that Exemption 3 of the FOIA covered all EWR submissions, including requests for the confidentiality of EWR information not within the scope of Appendix C to Part 512 as promulgated in 2003 and amended in 2004 and individual requests for confidentiality. The District Court rejected the contention that Exemption 3 applies to the EWR data, concluding that the disclosure provision affecting EWR data, 49 U.S.C. 30166(m)(4)(C), 22 did not qualify as an Exemption 3 statute because the provision does not prescribe a formula to enable the agency to determine precisely whether the disclosure of the data would be helpful in carrying out the recall notification and remedy provisions of the Safety Act. It also noted that the provision did not refer to particular matters that must be withheld. See Public Citizen , 444 F. Supp. 2d at 12.

RMA filed a notice of appeal of the District Court's Judgment. The contention that NHTSA is precluded by statute from releasing the early warning data is within the scope of this notice. Should the Court of Appeals reverse the District Court on this issue and decide that Exemption 3 does apply to EWR data, the agency may proceed to issue a final rule exempting EWR data from disclosure in a manner consistent with the Court of Appeal's decision or terminate the EWR Appendix C portion of this rulemaking as unnecessary.

We are not proposing to include property damage claims and notices of death, personal injury or property damage as part of our class determinations based on Exemption 4. These items involve a collection of information, many pieces of which are publicly available. In the particular circumstances of these data, we do not believe that the disclosure of this collected information would likely provide information that would be used competitively and result in substantial competitive harm. These kinds of claims tend to be more historical, rather than predictive, when compared to the other types of information required by the EWR regulation, with any apparent trends arising over longer periods of time. We consider it unlikely that information about claims of death, personal injury or property damage will be valuable to competitors such as in cross-company comparisons. We note also that manufacturers receive claims based on incidents occurring in the field, not as the result of proactive efforts to obtain data or customer feedback. They are required under 49 CFR Part 576 to retain this information and do not have the option to refuse to amass it.

Therefore, other than within the context of the Exemption 3 discussion above and except to the extent that the EWR submissions contain personal information covered by Exemption 6, these data categories lie outside the scope of this rulemaking.

We are also proposing to clarify NHTSA's Confidential Business Information rule, 49 CFR 512.6, regarding data claimed as confidential that are submitted in electronic form. The current regulation states requirements for paper submissions. See 49 CFR 512.6(a), (b)(1) and (2); see also 49 CFR § 512.8. It then states that if submitted in electronic format, a comparable method to of identifying the information claimed to be confidential may be used. If submitted on CD-ROM or other format, the item containing the information shall be labeled as containing confidential information. 49 CFR 512.6(c).

Some CD-ROMs that are submitted to us are not labeled or indelibly marked as confidential on the disk itself. We propose to require that the medium (e.g., the disk itself and not the plastic enclosure for the disk) be permanently labeled with the submitter's name, the subject of the information and the word “Confidential.” This is already the routine practice with some manufacturers. In addition, during our reviews of claims for confidential treatment, we often find that CD-ROMs do not properly designate the information that the submitters claim to be confidential. More particularly, individual files submitted electronically (e.g., pdf format) on CD-ROMs often contain documents in which each page claimed to be confidential is not labeled as confidential. Also, while a page may contain some information that is not confidential (e.g., identical information is publicly available) and some information that is within the claim for confidentiality under section 512.8, the submitter does not enclose each item of information that is claimed to be confidential within brackets. Today's proposal would require that the CD-ROM be marked permanently as confidential and that each page that contains confidential material be so marked. Also, the proposal would require that where only part of the information is within the scope of the claim, that part of the information be separately enclosed within brackets. Our proposed clarification seeks to minimize inadvertent disclosure of materials that are subject to a claim of confidentiality and eliminate any ambiguity on the scope of the claim in our review of these types of submitted documents.

During our reviews of claims for confidential treatment, we also find that files within CD-ROMs do not contain page numbers. Electronic submissions sometimes contain large numbers of files and folders. Not infrequently, these files contain numerous pages. When we deny a request for confidentiality for a particular page, we need to identify it with particularity. Individual pages within individual electronic files that lack page numbers ordinarily cannot be readily identified. In these instances, there are substantial implementation problems in identifying what page(s) are within the scope of the agency's grant of a request for confidentiality and what page(s) that are within the scope of the agency's denial. To eliminate these problems, we are proposing to add a provision requiring the inclusion of a sequential numeric or alpha-numeric system that would identify each page contained in an electronic submission. This may be added to the pages before they are scanned or in the course of the preparation of the CD-ROM. We note that the courts require page numbers in appendices. See e.g. , Federal Rule of Appellate Procedure 30.

The proposal also provides that electronic media may be submitted only in commonly available and used formats. This would include formats such as pdf, Word documents and Excel spreadsheets. From time-to-time, manufacturers submit information in proprietary or uncommon data bases. We have been unable to open and review these items and accordingly have denied the associated requests for confidentiality.

Finally, we would clarify that requests for confidential treatment for information submitted to the agency must provide the information claimed as confidential in a physical medium such as a CD-ROM. There have been occasions where manufacturers have attempted to submit information claimed as confidential via e-mail. Not only was this not allowed under the existing regulations, but tracking requests for confidential treatment submitted in this manner is very difficult and far more prone to error than a physical submission. This affects the agency's ability to provide timely responses to these requests and the Chief Counsel's office's ability to transmit the information to the relevant office within NHTSA. In addition, the Department of Transportation limits the overall amount of e-mail information that an individual may maintain, and this presents problems. It also creates storage issues. To ensure our ability to properly track and handle this information, our proposal would require that the information be placed on appropriate physical media, such as CDs, when requesting confidential treatment.

These changes would be included in a new § 512.6(c) which would replace § 512.6(b)(3). The proposed § 512.6(c) would read as follows:

Section 303(a)(11) of the Magnuson-Stevens Act requires each FMP to include provisions establishing “a standardized reporting methodology to assess the amount and type of bycatch occurring in the fishery.” The Councils and NMFS are considering an omnibus amendment to establish an SBRM or modify existing SBRMs under every Northeast Region FMP. The purpose of the amendment is to explain the methods and processes by which bycatch is currently monitored and assessed for Northeast Region fisheries, to determine whether these methods and processes need to be modified and/or supplemented, to establish standards of precision for bycatch estimation for all Northeast Region fisheries and, thereby, to document the SBRM established for all fisheries managed through the FMPs of the Northeast Region. The scope of the omnibus amendment is limited to those fisheries prosecuted in the Federal waters of the Northeast Region and managed through an FMP developed by either the Mid-Atlantic or New England Council.

Alternatives under consideration in the omnibus SBRM amendment address bycatch reporting and monitoring mechanisms, analytical techniques and allocation of at-sea fishery observers, establishment of a target level for precision of bycatch estimates, and requirements for reviewing and reporting on the efficacy of the SBRM. NMFS and the Councils will consider all comments received on the draft SBRM amendment and the alternatives for incorporation into the final document until the end of the comment period on December 29, 2006. The public will have several additional opportunities to comment on the SBRM. The final amendment will be considered for approval by the Councils at public meetings in February of 2007. Once submitted to NMFS, the final SBRM Amendment will be made available for public review and comment, and regulations will be proposed for review and comment in March 2007.

The public hearings have been scheduled to coincide with the date and location of New England and Mid-Atlantic Fishery Management Council meetings.

Tuesday, November 14, 2006, at 5:30 p.m. - Tavern on the Harbor, 30 Western Ave., Gloucester, MA 01930, telephone: (978) 283-4200.

Tuesday, December 12, 2006, at 7 p.m. - Skyline Hotel, 725 10th Ave, New York, NY 10019, telephone: (212) 586-3400.

These hearings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids at the Gloucester, MA, meeting should be directed to Paul J. Howard, Executive Director, New England Fishery Management Council, 50 Water Street, Mill 2, Newburyport, MA 01950. Requests for such services at the New York, NY, meeting should be directed to M. Jan Saunders, (302) 674 2331 extension 18. Requests for accessibility accommodations must be received at least at least 5 days prior to the meeting dates.