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Animal and Plant Health Inspection Service, USDA.
Final rule.
We are amending the Animal Welfare Act regulations to revise and clarify the exemptions from the licensing requirements, the procedures for applying for licenses and renewals, and the restrictions upon the acquisition of dogs, cats, and other animals. These actions are necessary to help ensure compliance with the regulations and the Animal Welfare Act.
Dr. Barbara Kohn, Staff Veterinarian, Animal Care, APHIS, 4700 River Road Unit 84, Riverdale, MD 20737-1234; (301) 734-7833.
The Animal Welfare Act (AWA) (7 U.S.C. 2131
On August 4, 2000, we published in the
We solicited comments concerning our proposal for 60 days ending on October 3, 2000. At the request of several commenters, we extended the comment period to November 20, 2000 (65 FR 62650, Docket No. 97-121-2). We received 395 comments by that date. They were from private citizens, professional organizations, licensees, and Congressional representatives.
A number of commenters offered general support for the proposed rule and APHIS' efforts to strengthen the licensing and renewal requirements. Many felt that these changes would help to improve conditions for the animals.
Several commenters stated that the AWA is unconstitutional and that the Government should stay out of their private lives. Several commenters also stated that changes in the regulations are unnecessary and that we merely need to enforce the requirements already in place. We disagree. The United States Department of Agriculture (USDA) has a duty to implement and enforce the AWA. APHIS believes that the proposed changes will improve the implementation of the AWA.
Several commenters stated that APHIS should not take on additional regulatory responsibilities until it is determined that there is sufficient manpower and budget to support the activity. One commenter expressed concern that APHIS had not considered how many additional entities would need to be licensed with the proposed regulation of small exotic or wild mammals. The commenter wondered if APHIS has the resources to handle these additional entities. We do not believe that implementing the changes we proposed will increase our workload under the AWA.
One commenter stated that many people were not aware of the proposed rule, especially if they did not have access to the Internet, and several commenters requested a second extension of the comment period. As evidenced by the number and diversity of comments we received, we believe that we provided adequate notice and opportunity for comment.
One commenter requested a personal reply. APHIS' policy is not to respond directly to individual commenters, but to take all comments into consideration and address them in another document published in the
Some commenters expressed concern that the proposed rule would put dog and cat dealers out of business, and they questioned why we regulate dogs and cats at all. The AWA specifically covers dogs and cats. APHIS does not believe that the proposed changes impose significant burdens.
Several commenters argued that dogs and cats should not be used in research, and that budget issues for researchers should not be dictating regulations. The AWA specifically prohibits the USDA from dictating what research is done (7 U.S.C. 2143). If research is done using species covered by the AWA, the research facility must comply with the AWA and regulations.
One commenter questioned why the proposed rule focused on dogs and cats when it had “started out aimed at dangerous animals.” Although we did propose changes to § 2.131 related to experience and knowledge required by licensees who maintain wild or exotic animals, the focus of the proposed rule was not on dangerous animals. Rather, the proposed rule was designed to revise and clarify the exemptions from the licensing requirements, the procedures for applying for licenses and renewals, and the restrictions upon the acquisition of dogs, cats, and other animals.
Based on the large number of inquiries concerning the scope and intent of the proposed rule, we wish to
Many commenters addressed the proposed amendments to § 2.1(a)(3)(iii) and (iv), which concern exemptions from licensing requirements.
In § 2.1, proposed paragraph (a)(3)(iii) exempts from licensing any person who maintains a total of three or fewer breeding female dogs, cats, and/or small exotic or wild mammals, such as hedgehogs, degus, spiny mice, prairie dogs, flying squirrels, and jerboas, and who sells only the offspring of these dogs, cats, or small exotic or wild mammals, which were born and raised on his or her premises, for pets or exhibition, and is not otherwise required to obtain a license.
Several commenters requested that we define “small exotic or wild mammal.” Some commenters requested a specific list of animals which would be considered small or exotic wild animals, and one commenter suggested that we identify general qualifications, such as adult size, to define these animals. One commenter expressed concern that these terms would create a loophole in the regulations.
We listed in proposed § 2.1(a)(3)(iii) some animals that we consider to be included in the term “small exotic or wild mammal.” This list merely identifies the types of animals normally considered to be in this category; it is not intended to be an exhaustive list. Including an exhaustive list would be difficult and counterproductive, since additions or deletions from such a list in the regulations would require rulemaking, and we cannot predict what animals may be marketed as pets in the future. Accordingly, we are making no changes based on these comments.
Another commenter requested that we define “breeding female.” The commenter questioned whether an animal capable of reproducing would be considered the same way as a pregnant animal. For purposes of the AWA, “animal” is defined in § 1.1 as including any warm-blooded animal (not exempted elsewhere) that is used or intended for use in regulated activities. Consequently, if an animal is being kept to produce offspring for sale into the wholesale pet trade, for research, or for teaching or exhibition purposes, that animal will be considered covered under § 2.1(a)(3)(iii), even if it is not pregnant or being bred during the current breeding cycle. This prevents a person from rotating animals in the breeding program to avoid licensing requirements. For these reasons, we are making no change based on this comment.
One commenter suggested that APHIS exempt from licensing any person who maintains a total of five or fewer breeding female small exotic or wild mammals (commonly known as pocket pets). We proposed to amend § 2.1(a)(3)(iii) to include in the exemption from licensing persons who maintain three or fewer breeding female pocket pets on a single premises because we do not believe that the risk associated with their maintenance warrants our inspection of the premises or requires the issuance of a license. We believe that the same provisions should apply to small exotic and wild animals as apply to dogs and cats. Therefore, we are making no change based on this comment.
One commenter stated that legitimate breeders need more than three breeding females on the premises and that the proposed regulations harass and tax legitimate breeders, rather than regulating “puppy mills.”
The exemption for three or fewer breeding females is designed to exempt
The current § 2.1(a)(3)(iv) exempts from licensing any person who sells fewer than 25 dogs and/or cats per year, which were born and raised on his or her premises, for research, teaching, or testing purposes or to any research facility and is not otherwise required to obtain a license. The proposed rule did not create the exemption but merely clarified it so that persons acting in concert could not evade the limitation.
A number of commenters argued that the limit for exemption from licensing should be reduced to three or fewer. Similar changes have been suggested in the past. However, since most dogs and cats have an average litter size of more than three animals, we believe such a provision would be unduly limiting. Individuals would be prohibited from selling even one litter a year for regulated purposes unless they were licensed under the AWA. Thus, a limit of three or fewer animals would not be a practical or enforceable requirement. The threshold of 25 dogs or cats for licensure has been a regulatory provision for over 15 years. In addition, one commenter argued that there is a disparity in the parameters used to determine activity thresholds for licensure, with no direct correlation between the provisions for 25 or fewer dogs or cats sold per year, 3 or fewer breeding females, and the $500 gross income from the sale of domestic animals for regulated purposes (see § 2.1(a)(3)). We disagree. All of these provisions are designed to exempt
In § 2.1, proposed paragraph (a)(3)(iii) states that the exemption from licensing does not extend to any person residing in a household that collectively maintains a total of more than three breeding female dogs, cats, and/or small exotic or wild mammals, regardless of ownership, nor to any person maintaining breeding female dogs, cats, and/or small exotic or wild mammals on premises on which more than three breeding female dogs, cats, and/or small exotic or wild mammals are maintained, nor to any person acting in concert with others where they collectively maintain a total of more than three breeding
One commenter expressed concern about the phrase “acting in concert” in proposed §§ 2.1(a)(3)(iii) and 2.1(a)(3)(iv). Specifically, the commenter was concerned that breeders with partial ownership in a number of breeding animals would be considered to be “acting in concert” with their partners and, therefore, would not be exempt from licensing.
The proposed changes to §§ 2.1(a)(3)(iii) and 2.1(a)(3)(iv) are designed to close a loophole in the regulations. Some individuals have contended that they are not required to have a license even when they keep more than three breeding female dogs and/or cats on the same premises as long as no single member of the household owns more than three. However, when several members of the same household (or other persons acting in concert) are maintaining breeding female dogs or cats on the same premises such that the number of breeding females in total is more than three, we believe that the activities are no longer
Currently, § 2.1(b) provides that a person who is exempt from licensing under § 2.1(a)(3)(iv) may apply for a voluntary license. Since this option has rarely been exercised, we proposed to eliminate this provision. We received several comments on this issue. All of the commenters supported our proposal to eliminate voluntary licenses.
Currently, § 2.1, paragraphs (d)(2), (e)(1), and (e)(2) (redesignated as (c)(2), (d)(1), and (d)(2) in this final rule) provide that a license will not be issued until payment has cleared normal banking procedures. We proposed to remove this provision. Commenters generally supported the issuance of a license when the fee is paid, rather than when a check clears. One commenter supported proposed § 2.1(d)(1) as long as it was understood that a returned or bounced check would result in denial of the license or renewal. We note that a returned check for a license or renewal will result in denial of the license or renewal.
Several commenters also supported proposed provisions to submit fees for licenses to the appropriate Animal Care (AC) regional office, rather than the AC Regional Director, and to specify that the license fee is due on or before the date of expiration of the license.
One commenter recommended that we allow fees for licenses and renewals to be paid by credit card. We currently allow fees to be paid with major credit cards. To clarify the available payment options, in this final rule, § 2.1(d)(1) and § 2.1(d)(2) provide that payment of fees for licenses and renewal of licenses, as well as for changes in class of license, can be made using a credit card, in addition to personal check, certified check, cashier's check, and money order. Regional offices can be contacted for details on these transactions.
We proposed to amend § 2.2(b) to remove the provision stating that APHIS will supply copies of the regulations and standards to licensees as part of the license renewal process. We believed that most parties did not want or need these yearly copies. However, comments on this issue were split. Several commenters supported this provision as long as all regulated parties were notified of the changes in the rules, while other commenters thought that we needed to continue providing copies of the regulations and standards as part of the license renewal process.
Currently, regional offices inform all licensees and registrants of all applicable regulatory changes. In addition, all AWA regulations and standards are available on the Internet at
In § 2.3, proposed paragraph (b) states that each applicant for an initial license must be inspected by APHIS and demonstrate compliance with the regulations and standards before APHIS will issue a license. If the first inspection reveals that the applicant's animals, premises, facilities, vehicles, equipment, other premises, or records do not meet the requirements of 9 CFR Chapter 1, subchapter A, APHIS will advise the applicant of existing deficiencies and the corrective measures that must be completed to come into compliance with the regulations and standards. An applicant who fails the first inspection will have two additional chances to demonstrate his or her compliance with the regulations and standards through a second inspection by APHIS. The applicant must request the second inspection, and if applicable, the third inspection, within 90 days following the first inspection. If the applicant fails inspection or fails to request reinspections within the 90-day period, he or she will forfeit the application fee and cannot reapply for a license for a period of 6 months from the date of the failed third inspection or the expiration of the time to request a third inspection.
One commenter suggested that APHIS should ensure that new licenses are not issued without careful scrutiny of the facility. The commenter asserted that a research facility, that identified itself as a pet shop, was issued a license.
Before an initial license is issued, an applicant must be inspected by APHIS and demonstrate compliance with the regulations and standards. During the inspection, APHIS ascertains the nature of the operation and determines if the applicant needs to be licensed or registered. Under § 2.30, a research facility must be registered, not licensed.
Several commenters stated that we should allow only two prelicensing inspections per application while others stated the entire prelicensing period should be only 60 days in length. Most other commenters supported a time limit on the prelicensing process, although one commenter felt the timeframe should be extended to 6 months.
A review of Animal Care records indicates that few applicants require three prelicensing inspections to complete the process, but even those applicants that require three prelicensing inspections usually complete the process within 90 days.
We encourage applicants to establish contact and dialogue with their inspector prior to requesting a prelicensing inspection to make sure the facility is in compliance. It will not increase our regulatory burden to maintain the availability of three
Several commenters suggested that anyone who failed to complete or pass the prelicensing inspection process within the proposed timeframe should be required to wait 1 year, rather than 6 months, to reapply. The commenters provided no explanation to support the longer waiting period. To date, we have not experienced any significant enforcement problems related to the 6-month waiting period. Therefore, we are making no change based on these comments.
One commenter requested that APHIS clarify § 2.3(b) to indicate the application termination and waiting period if the applicant never requests reinspection. In § 2.3, proposed paragraph (b) states that if the applicant fails inspection or fails to request reinspections within the 90-day period, he or she will forfeit the application fee and cannot reapply for a license for a period of 6 months from the date of the failed third inspection or the expiration of the time to request a third inspection. We believe that proposed § 2.3(b) adequately describes the process for demonstrating compliance with the standards and regulations, and additional clarification is not necessary. Accordingly, we are making no change based on this comment.
Currently, § 2.5(a) provides that a license shall be valid and effective unless the license has been revoked or suspended pursuant to section 19 of the AWA, the license is voluntarily terminated upon request of the licensee, the license has expired or been terminated under the regulations, or the applicant has failed to pay the annual license fee.
One commenter recommended amending § 2.5(a) to provide that a license may be denied to a person who has not paid a monetary penalty assessed for AWA violations. Such a change would be impractical given due process considerations and provisions for monetary penalties to be deferred, suspended, or subject to a payment plan. Accordingly, we are making no change based on this comment.
Currently, § 2.5(b) provides that APHIS will notify a licensee by certified mail at least 60 days prior to the expiration date of the license. We proposed to eliminate this notification by certified mail.
Several commenters requested that license renewal notices continue to be delivered via certified mail. These commenters were concerned that the notices would be lost in regular mail and noted that the cost of certified mail was not prohibitive. Another commenter stated that delivery of license renewal notices via regular mail was fine, but recommended that a second notice be sent as a backup in case the first notice was never delivered.
We do not believe that using regular mail decreases our ability to communicate with licensees. All licensees rely on regular mail to run their businesses and all licensees are required to notify Animal Care of any change in address. Furthermore, expiration dates are printed on all license certificates and provide additional notice to the licensee. Therefore, we are making no change based on these comments.
Current § 2.5(c) provides that licensees must accept delivery of registered mail or certified mail notice and provide the AC Regional Director notice of their address in accordance with § 2.1. However, since we proposed to eliminate notification by certified mail, this provision is no longer necessary and should have been removed in the proposed rule. Therefore, we are removing § 2.5(c) in this final rule and redesignating paragraphs (d) through (f) as paragraphs (c) through (e), respectively.
Several commenters stated that the provisions in proposed §§ 2.1(d) and 2.5 related to payment of fees were confusing. The commenters noted that proposed § 2.1(d)(1) provides that a returned check will be deemed nonpayment of fee and will result in the denial of the license; proposed § 2.5(a)(4) provides that a license shall be valid and effective unless the annual license has not been paid,
We agree that the grace period provided for in proposed § 2.5(a)(4) is confusing in light of the language in proposed § 2.5(b), which provides that a license will be automatically terminated if the annual license fee is not received on or before the expiration date of the license. Initially, we had contemplated proposing a grace period for late payment of fees, and provisions for a grace period appeared in early drafts of the proposed rule. However, after further review, we elected not to propose a grace period for late payment of fees and the inclusion of the grace period provision in proposed § 2.5(a)(4) was an oversight. For this reason, we are removing the grace period provision in § 2.5(a)(4) in this final rule.
We proposed to amend the regulations at § 2.6, which set out annual license fees, to combine the $10 application fee for license renewals (or change of license class) with the annual license fee so that persons already licensed would need to submit only one check or money order annually. All commenters on this issue supported the proposed changes.
Currently, § 2.10(a) provides that any person whose license has been suspended for any reason shall not be licensed in his or her own name or in any other manner within the period during which the order of suspension is in effect. Furthermore, no partnership, firm, corporation, or other legal entity in which any such person has a substantial interest, financial or otherwise, will be licensed during that period. We proposed to amend § 2.10(a) by providing that no license will be renewed during the period that it is suspended.
One commenter wondered whether, under § 2.10, a license not renewed during a suspension of licensure is automatically terminated. The commenter stated a license should be terminated if the expiration date occurs during a period of suspension. A license suspension is not intended to be a license termination or denial. If a license expires during a suspension, the licensee must follow the renewal process when the suspension is lifted, and a decision will be made at that time about whether the license should be renewed. However, to clarify this issue, § 2.10(a) in this final rule states that renewal of a license may be initiated during a suspension in accordance with §§ 2.2(b) and 2.12.
Currently, § 2.11(a) provides that a license will not be issued to any applicant who: (1) Has not complied with the requirements of §§ 2.1, 2.2, 2.3, and 2.4 and has not paid the fees indicated in § 2.6; (2) is not in
We proposed to amend § 2.11(a) by revising paragraphs (a)(4) and (a)(5) and adding a new paragraph (a)(6). These proposed paragraphs provided that a license will not be issued if the applicant: (4) Has pled
A number of commenters recommended stricter conditions for licensure. To protect both animals and USDA inspectors, several commenters recommended permanent denial of a license to any convicted felon or the equivalent, or anyone convicted of animal cruelty. One commenter recommended that any person who violated any animal-related laws be denied a license and not be allowed to assist or participate with other persons to conduct regulated activities. Another commenter recommended that no corporation whose officer(s) were convicted of a felony should be licensed under the AWA. One commenter suggested we deny a license to any person that an animal registry body (
The changes we proposed to § 2.11(a) give the Administrator the broad discretion to deny a license to applicants who have pled
One commenter suggested that any conviction for animal cruelty, not just those in the last year, should be considered when determining license eligibility. We note that proposed § 2.11(a)(4) provides that a license will not be issued to any applicant who has pled
Several commenters stated that license eligibility should not be based on past convictions because everyone deserves a second chance. The intent of the AWA is to provide for the humane care and treatment of all animals covered by the Act, and prior convictions for animal cruelty are germane to deciding the appropriateness of licensure. Accordingly, we are making no change in response to these comments.
One commenter expressed concern that stipulation agreements would be considered
One commenter stated that APHIS should be clear that the proposed conditions for licensure in § 2.11 also apply to judicial orders (
A number of commenters were concerned about the use of the term “unfit” in § 2.11(a). Several commenters requested that we define “unfit,” perhaps with a list of what makes a person unfit to hold a license. Several commenters requested that we delete this term altogether. Other commenters questioned our authority to judge an individual and determine them to be “unfit.”
We are not making any changes based on these comments. The Administrator will assess the suitability, or “fitness,” of an applicant to provide for the humane care and treatment of animals as required by the AWA and regulations. Listing all possible reasons for this determination is not possible and any attempt to do so would remove necessary flexibility in decisionmaking. We note that any person denied a license can request a hearing to appeal the decision.
One commenter expressed concern that proposed § 2.11(a)(6) did not include the same 1-year disqualification from becoming licensed as § 2.11(a)(4). Another commenter stated that § 2.11(a)(6) was overly broad because violations of laws pertaining to “ownership” could refer to leash-law
We proposed in § 2.11(b) that an applicant whose license application has been denied may request a hearing, and that the license denial shall remain in effect until the final legal decision has been rendered. Should the license denial be upheld, the applicant may again apply for a license 1 year from the date of the final order denying the application, unless the order provides otherwise.
Several commenters recommended that a person denied a license be prevented from applying for another license for 1 year. Some commenters suggested even longer waiting periods before an applicant could reapply for a license. Requiring a time limit of 1 year before an application can be resubmitted has proven to be a reasonable time. We have not found a need to extend this period. After waiting a year, the applicant must go through the entire licensing process again, meeting all requirements. The applicant is again subject to all the provisions of § 2.11. There is no guarantee of a license being issued after the 1-year wait. Accordingly, we are making no changes based on these comments.
Several commenters suggested replacing the phrase “unless the order provides otherwise” with the phrase “unless the order provides for a longer period of time” because an applicant should not be able to reapply for a license less than 1 year from the date of the denial. The language in proposed § 2.11(b) is sufficient to indicate that an applicant whose license application has been denied may reapply for a license 1 year from the date of the final order denying the application, unless the hearing judge orders an extended period of license denial. While we recognize the commenters' concerns, a hearing judge may find that a shorter period of time is appropriate in a particular case. Therefore, we are making no change based on this comment.
In § 2.12, we proposed that a license may be terminated for any reason that an initial license application may be denied pursuant to § 2.11 after a hearing in accordance with the applicable rules of practice.
One commenter suggested that all licenses for Class B dealers be revoked at the first sign of any AWA violation and the animals should be seized without prior notice or trial. The commenter also suggested that no appeals should be allowed for revocation of a license and that no family member of an individual whose license has been revoked should be granted a license.
These recommendations would violate the principles of due process if implemented; therefore, we are making no change based on this comment. However, we note that we can prevent licensure of some persons if it is evident that such a licensure would circumvent provisions of the AWA and/or a revocation order (see § 2.11(d) in this final rule).
One commenter stated that we should not change § 2.12, allowing for individual decisions to be made on a case-by-case basis. Another commenter stated that using the phrase “or at any time” gives us too much power to make denials permanent, perhaps disregarding the sincere commitment of a person to change. This commenter's main concern was that APHIS has too much power to make denials permanent.
APHIS continues to look at cases on an individual basis, as warranted. The language in proposed § 2.12 allows APHIS to more effectively enforce the AWA by allowing consideration of all salient factors during the licensing process. It should be remembered that anyone denied a license is entitled to appeal the decision at a hearing. This process protects applicants whose license applications have been denied. For these reasons, we are making no changes based on these comments.
Several commenters requested that we clarify that a license renewal may be denied for the same reasons as an initial license application may be denied (
These recommendations are already addressed by proposed § 2.12, which provides that a license may be terminated, after a hearing, for any reason that an initial license application may be denied pursuant to § 2.11. Therefore, we are making no changes based on these comments.
Several commenters suggested adding criteria for renewal of licenses in § 2.12. One commenter suggested that licenses should not be renewed if there were any AWA violations within the last 3 years and the facility had not been inspected within the last year. Another commenter suggested that no license should be renewed unless the facility was inspected and found compliant just prior to the renewal date.
Enforcement of the AWA is based on random, unannounced inspections to determine compliance. In addition, APHIS uses a risk-based assessment to determine minimum inspection frequency. After inspection, all licensees are given an appropriate amount of time to correct any problems and become compliant. This cooperative system has been more effective than enforcement actions for each citation. Furthermore, a significant number of citations are for conditions that do not directly or immediately impact the health and well-being of the animals. It is unrealistic and counterproductive to make license renewal contingent on not having any citations. Accordingly, we are making no changes based on these comments.
Several commenters supported the provisions for termination of licensing but expressed concern over the care of animals at facilities where such terminations were implemented. One commenter suggested that we perform additional inspections pending a termination hearing. Since we already take steps to ensure the humane care of animals in these circumstances (
Section 2.126 sets forth the requirements concerning access and inspection of records and property. We proposed to amend § 2.126(b) to add a provision that a responsible adult must be made available to accompany officials during the inspection process.
Some commenters interpreted proposed § 2.126(b) to mean that an adult needed to be at the facility at all times. They stated that this would pose an undue burden and cost on the operation. Several commenters suggested that, based on the assumption that proposed § 2.126(b) would require an adult onsite at all times, the inspector notify the licensee of the
We intended that a responsible adult be made available to accompany the APHIS inspector. This would not require that the adult be onsite at all times. The current regulations require that the licensee make the facility available for inspection during business hours, which is defined in § 1.1 of the regulations to mean a reasonable number of hours between 7 a.m. and 7 p.m., Monday through Friday. Therefore, we are making no change based on these comments.
Several commenters requested that we define “responsible adult.” It is the responsibility of the licensee to accommodate APHIS inspections, and if the owner(s) are not available, it is their responsibility to designate an adult to represent their interests with respect to the inspection. We believe that common usage of the term “responsible” in relation to the licensed business is sufficient to define “responsible adult.” Therefore, we are making no change based on these comments.
One commenter stated that APHIS inspectors should inspect the premises unaccompanied if no responsible adult is available. Another commenter noted that this would constitute an illegal search of the premises. We do not perform unaccompanied inspections for many reasons, including the safety of the inspector. Therefore, we are making no change based on these comments.
Two commenters argued that no pictures should be taken during an inspection without the owner's permission. We did not propose to amend § 2.126(a)(4) and (5), which state that APHIS inspectors may inspect and photograph the facilities, property, and animals and may document, by the taking of photographs and other means, conditions and areas of noncompliance. Taking photographs during routine inspections is sometimes necessary to document any noncompliant items and conditions. Accordingly, we are making no change based on these comments.
We proposed adding a new requirement to § 2.131 that all licensees who maintain wild or exotic animals must demonstrate adequate experience and knowledge of the species that they maintain. In the proposed rule, these animals were described as “potentially dangerous.”
One commenter stated that some of the terminology in § 2.131 was ambiguous; specifically, the commenter wondered if the proposed requirement related to all wild or exotic animals or only to potentially dangerous animals. The commenter suggested that, if the proposed requirement related to potentially dangerous animals, APHIS should use the phrase “inherently dangerous animals” instead of “potentially dangerous animals.” The commenter noted that many species of animals can be regarded as potentially dangerous, but there are some species which pose an inherent threat.
Proposed § 2.131 is intended to apply to all wild or exotic animals, which include, but are not limited to, “potentially dangerous animals.” Therefore, we are making no change based on this comment.
Most commenters supported the intent of proposed § 2.131 but requested more information as to what constitutes “adequate experience and knowledge.” Commenters suggested that “adequate experience and knowledge” was equivalent to a minimum of 4 years of working with the species involved or 1,000 hours of hands-on experience with the species. One commenter said experience and knowledge of comparable species should be applicable to any requirement.
We believe that this performance based standard will provide us with sufficient discretion to analyze each unique situation. Therefore, we are making no change based on these comments. However, we note that APHIS is currently examining this issue and will initiate rulemaking for any changes deemed appropriate.
A commenter suggested that § 2.131 should apply to registrants as well as licensees. The commenter noted that some registrants may also maintain wild or exotic animals.
We do not believe it is necessary for proposed § 2.131 to apply to registrants as well as licensees. Research facilities are already required to have an Institutional Animal Care and Use Committee that is qualified through experience and expertise to assess the facility's animal program. For this reason, we are making no change based on this comment.
One commenter requested that we clarify who must have this experience (
Institutions and corporations can only have knowledge and experience through the persons they employ or retain. We do not believe that it would be practical to attempt to specify how a licensee would possess and demonstrate adequate experience and knowledge. Accordingly, we are making no change based on these comments.
One commenter noted that there may be instances where it would be impractical or impossible for an individual to obtain experience with a particular species of animal (
In cases where it has been impractical or impossible for an individual to obtain experience and knowledge of a particular species, APHIS has historically considered the individual's experience and knowledge of comparable species. The Administrator will continue to make determinations regarding adequate experience and knowledge on a case-by-case basis. Accordingly, we are not making a change based on this comment.
A commenter asked for clarification as to how the handling requirements in the proposed rule related to the recently published amendments to the marine mammal regulations (66 FR 239-257, Docket No. 93-076-15) and the draft policy on training and handling of potentially dangerous animals (65 FR 8318-8321, Docket No. 97-001-4). The commenter expressed concern about APHIS applying the proposed handling requirements to exhibitors maintaining marine mammals since APHIS has previously treated marine mammals as “wild animals.”
This final rule and the marine mammal final rule address different aspects of AWA enforcement. This final rule relates to inspection, licensing, and procurement of animals, while the marine mammal final rule addresses the specific handling, care, and transportation needs of marine mammals. This final rule and the marine mammal final rule complement each other to ensure the humane care and treatment of animals covered by the AWA. As for the draft policy, APHIS will not be publishing or implementing a final policy statement on training and handling potentially dangerous animals because we have determined that any clarification of the regulations should be
One commenter asserted that all photographic shoots and animal rides should be banned. It is beyond the scope of our authority to ban photographic sessions and animal rides. Therefore, we are making no change in response to this comment.
Currently, § 2.132 of the regulations concerns the procurement of random source dogs and cats by Class B dealers. We proposed several changes to § 2.132 of the regulations to clarify these provisions.
One commenter wanted us to include Class A dealers in proposed § 2.132. Class A dealers breed and raise the animals they sell on their own premises. The proposal does include Class A dealers.
One commenter suggested that we hold research facilities responsible for acquisitions from unlicensed persons and hold dealers responsible for purchases from “bunchers.” Although “bunchers” are not defined under the AWA, the term is commonly considered to mean parties that collect, gather, or aggregate animals from other sources for dealers. Dealers are already responsible for the actions of their employees and agents, however described. The proposed rule would prohibit dealers from acquiring animals through “bunchers” who are operating as unlicensed dealers. Therefore, we are making no change based on this comment.
One commenter recommended that we retain the previous § 2.132(b), which defined random source animals. The definition of “random source” animals may be found in § 1.1 of the regulations. Therefore, we are making no change based on this comment.
We proposed in § 2.132(d) that no dealer or exhibitor shall knowingly obtain any dog or cat from any person who is not licensed, other than a pound or shelter, without obtaining a certification that the animals were born and raised on the person's premises and, if the animals are for research purposes, that the person has sold fewer than 25 dogs and/or cats that year, or, if the animals are for use as pets, that the person does not maintain more than three breeding female dogs and/or cats.
Several commenters supported this proposal, but recommended that we ensure that identification numbers or driver's license numbers are recorded on the certification statement and any other paperwork. Several commenters suggested that additional information be recorded, such as the animal descriptions/characteristics, phone number of seller, full name and address of seller. Other commenters suggested that, in addition to the certification statement, APHIS should require additional documentation (
As noted previously, we believe that the requirements in part 2 of the regulations are adequate for purposes of the AWA to establish ownership of animals. The name, address, and driver's license number of the seller are currently recorded on the acquisition/disposition records of the dealer, exhibitor, or research facility. It would be redundant to require such information on the certification statement. Furthermore, the information required in this final rule would be sufficient to initiate any formal investigations needed involving the dealers and/or the suppliers. For these reasons, we are making no changes based on these comments.
One commenter wanted to make sure that the certification statement required in § 2.35 was the same as in § 2.132. Another commenter stated that the certification requirements in § 2.35 should be the same as those found in § 2.133. The information requirements of §§ 2.35, 2.132, and 2.133 are consistent and appropriate for the intended buyers and sellers. Therefore, we are making no changes based on these comments.
One commenter stated that the current acquisition requirements in part 2 are unacceptable and negligent. The commenter suggested that APHIS attend each auction and cross-reference the names of persons observed selling animals with the forms submitted to APHIS for at least 1 year. It is not feasible for APHIS to attend every auction and cross-reference the names of persons observed selling animals with the forms submitted to APHIS. As previously noted, the current recordkeeping requirements, supplemented by the requirements in this rule, are designed to ensure that animals are legally acquired and can be traced back to their previous owners if necessary. Accordingly, we are making no change based on this comment.
The regulations currently require dealers, exhibitors, operators of auction sales, brokers, and research facilities who acquire animals from persons who are not licensed to record the driver's license number of the person. We proposed to add provisions in §§ 2.35(b)(3), 2.75(a)(1)(iii), 2.75(b)(1)(iii), and 2.76(a)(4) to allow the use of officially issued photographic identification cards for nondrivers in lieu of a driver's license. Many commenters supported the proposal to allow the use of officially issued photographic identification cards in lieu of a driver's license.
We proposed a number of minor changes to the regulations to reflect current APHIS form numbers, change references from Veterinary Services to Animal Care, correct grammar, and replace “sector” references with appropriate references to AC regional offices. We received one comment in support of these proposals. No negative comments were received. Therefore, we are making no changes in this final rule to the following sections: §§ 2.35, 2.38, 2.75, 2.76, 2.78, and 2.102.
We proposed in § 2.38(k)(2), compliance with standards and prohibitions, that no person shall obtain live dogs or cats by use of false pretenses, misrepresentation, or deception. Several commenters supported or strongly agreed with this provision. Accordingly, we are making no changes in response to these comments.
One commenter requested that the USDA exempt research facilities from having to be licensed as dealers if they buy, sell, trade, etc., animals incidental to research. We note that research facilities are not required to be licensed as dealers if they are buying animals, receiving or placing animals as donations, or trading animals with other research facilities. However, if a research facility is selling animals to other research facilities, pet stores, or for exhibition purposes, the research facility must be licensed as a dealer.
Several commenters stated that health certificates for animals should be used to validate ownership and help prevent the spread of disease. We believe that the requirements in part 2 of the regulations for documenting ownership are adequate for purposes of the AWA to establish ownership of animals. A related comment proposed that all animals used in research be certified as to who bred and raised them, that they were voluntarily provided to the dealer, and that the original owners agreed to their use in research. However, we believe such certificates are unnecessary because the changes to § 2.132, combined with the holding periods and other requirements of section 2158 of the AWA and § 2.101 of the regulations, provide sufficient safeguards. Accordingly, we are making no changes based on these comments.
One commenter requested that we amend the licensing requirements to eliminate all Class B dealers. Class B dealers may acquire and sell animals. There are currently fewer than 30 Class B dealers who purchase and sell random source animals. The majority of Class B dealers do not engage in random source animal activities. Elimination of random source activity would require an amendment to the AWA and is beyond the scope of this rule.
One commenter suggested that APHIS establish a definition for
One commenter asked about the identity of the “Administrator.” The Administrator is defined in § 1.1 of the regulations and refers to the Administrator of APHIS or any other official of APHIS authorized to act for the Administrator of APHIS. Thus, although the term “Administrator” is used in our regulations, reporting and recordkeeping documents are generally submitted to the regional offices. All questions concerning where documents should be submitted can be directed to the appropriate regional office.
One commenter stated that the Animal Care Annual Report to Congress on the enforcement of the AWA uses the terms “violation” and “alleged violation” interchangeably and cautioned us to make sure the terms are clear and consistent in §§ 2.11 and 2.12. The term “alleged violation” is not used in either section, only the phrases “operating in violation” and “found to have violated.”
Another commenter requested a “no trespassing-disease control” regulation. However, such an activity is beyond the scope of the AWA and this rulemaking.
One commenter suggested that enforcing existing temperature regulations would help control “puppy mills.” That issue is beyond the scope of this rulemaking.
One commenter stated that the proposed rule contained no discussion of the paperwork burden or economic burden associated with the proposed changes. Those issues were discussed under the headings “Paperwork Reduction Act” and “Executive Order 12866 and Regulatory Flexibility Act,” respectively.
Therefore, for the reasons given in the proposed rule and in this document, we are adopting the proposed rule as a final rule, with the changes discussed in this document.
This 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.
In accordance with 5 U.S.C. 604, we have performed a final regulatory flexibility analysis, which is set out below, regarding the economic effects of this rule on small entities. This discussion also serves as our cost-benefit analysis. A discussion of the comments received concerning the proposal is set forth in the sections analyzing the regulatory provisions.
Under the Animal Welfare Act (7 U.S.C. 2131
This rule will amend the Animal Welfare Act regulations in 9 CFR part 2 to revise and clarify the exemptions from the licensing requirements, the procedures for applying for licenses and renewals, and restrictions upon the acquisition of dogs and cats and other animals.
Class A and B dealers, Class C exhibitors, registered exhibitors, research facilities, and individuals who are currently exempt from licensing are the entities that would be affected by this proposed rule. A Class A dealer breeds and raises animals to be sold for research, teaching, testing, experimentation, exhibition, or for entry into the wholesale pet trade. A Class B dealer is a person, including a broker and operator of an auction sale, whose business includes the purchase and/or resale of any animal. A Class C exhibitor or registered exhibitor is a person, including an animal act, carnival, circus, and public and roadside zoo, who shows or displays animals to the public. Research facilities include schools, institutions, organizations, or persons who use live animals in research, tests, or experiments.
The regulations exempt from licensing any person who maintains a total of three or fewer breeding female dogs and/or cats and sells only the offspring of these dogs and/or cats for pets or exhibition. This rule will extend this exemption from licensing to any person who maintains a total of three or fewer breeding female small exotic or wild mammals and sells only the offspring of these small exotic or wild mammals for pets or exhibition. This rule will also clarify that the exemption applies only if a total of three or fewer breeding female dogs, cats, and/or small exotic or wild mammals, such as hedgehogs, degus, spiny mice, and prairie dogs, are maintained on a single premises, regardless of who owns the animals.
Unlicensed individuals in this category primarily sell the offspring of their animals to pet stores and private citizens and their number and the quantity of their sales are unknown. The number of currently unlicensed individuals who will have to become licensed as a result of this rule is also unknown, although they are likely to be considered small entities. Those affected will either have to obtain a license and pay the associated fee,
The extension of the licensing exemption to small exotic or wild mammals should have little impact. With the extension of this exemption, some breeders who are now licensed would no longer need to be licensed. However, because APHIS has only recently begun to require licenses for breeders of small exotic or wild mammals at all, only a small number of breeders would be affected. For that small number, there will be cost savings in the amount of the annual license fee that would no longer be required.
The regulations exempt from licensing any person who sells fewer than 25 dogs and/or cats per year for research, teaching, or testing purposes if the dogs and cats were born and raised on the person's premises. This rule will clarify that this exemption would apply
These changes would potentially affect four groups of entities: (1) Persons who are currently exempt from the licensing requirements; (2) licensed Class B dealers who acquire dogs and/or cats from persons exempt from licensing; (3) the research, testing, and education industries; and (4) Class C exhibitors who acquire dogs and/or cats from persons exempt from licensing.
It is estimated that in fiscal year (FY) 2002 approximately 6,200 dogs and cats
Class B dealers are the second group potentially affected by this rule. Nearly all dogs and cats supplied for use in the research industry by persons exempt from licensing were sold to the research industry through Class B dealers. Class B dealers obtain dogs and cats for sale to registered research facilities from pounds, Class A dealers, other Class B dealers, and persons exempt from licensing. The number of Class B dealers is limited and has been declining in recent years. We estimate that there were 18 Class B dealers supplying dogs and cats to research in 2002. In 2002, those 18 Class B dealers obtained approximately 6,200 dogs and cats from individuals who were exempt from licensing. This represents about a third of the dogs and cats Class B dealers provided to research.
The impact of this rule on Class B dealers should be small. This rule requires little added time or effort on the part of the dealer. Obtaining certification will take very little time and will be added to the information the dealer is already collecting on unlicensed sellers. Class B dealers could lose a primary source of animals due to the clarification that the exemption applies to the premises, regardless of ownership, or if Class B dealers choose to avoid collecting the required certifications. If this should occur, Class B dealers would have to turn to other sources (
Class B dealers most likely would not acquire animals from Class A dealers because of the higher cost. Class B dealers usually pay a person exempt from licensing approximately $50 for a dog and $25 for a cat. Class A dealers, who sell directly to research facilities, charge $300 to $500 per dog and slightly less per cat. Pounds and shelters may not be able to supply Class B dealers with the number of dogs and/or cats they need to maintain their current levels of operation. Nearly all of the dogs and cats supplied by persons exempt from licensing for use in the research industry were sold to the research industry through Class B dealers.
The impact of this rule on research facilities will primarily depend on the rule's impact on Class B dealers. According to researchers, animals bred specifically for research are not suitable for all studies. Of the 92,475 dogs and cats used in research in FY 2002, about 30 percent were random source animals, with about two-thirds of those obtained from Class B dealers.
The impact of this rule on Class C exhibitors should be very small. This rule will require that exhibitors obtain a certification from unlicensed sellers that they are not required to be licensed or registered by APHIS, a small addition to the information the exhibitors must already collect. In addition, of the more than 2,000 licensed exhibitors, we are unaware of any which obtain dogs and/or cats from unlicensed individuals.
This rule will make a number of changes to clarify the regulations and correct deficiencies we have found in enforcing the regulations. This rule will also amend a number of administrative procedures to make them more efficient. For instance, individuals applying for license renewal or change in license class will now be able to combine the license fee and application fee in a single form of payment. This rule should have little impact on licensees and should reduce APHIS' administrative burden.
Other changes, such as the additional criteria for denial of an initial license and termination of a license, make it easier to prevent individuals who are unfit to hold licenses. These changes would not have a significant economic effect on affected entities because the changes should not alter the day-to-day operations for entities that are currently in compliance with the Act.
The Regulatory Flexibility Act requires that we specifically consider the economic effects of this rule on small entities. As stated previously, the entities likely to be affected by this rule are Class A and B dealers, Class C exhibitors, registered exhibitors, research facilities, and individuals who are currently exempt from licensing.
We have used all available data to estimate the potential economic effects of the amendments to 9 CFR part 2 on small entities. However, some of the data we believe would be helpful in making this determination has not been available. Specifically, data are not available on the number of individuals who would be affected by the changes in exemptions from the licensing requirements. In our proposed rule, we asked the public to provide such data. However, none of the comments we received addressed this economic issue.
The Small Business Administration (SBA) has established size criteria by the North American Industry Classification System (NAICS) for determining which economic entities meet the definition of a small entity.
According to the SBA, Class A dealers (NAICS 1129, other animal production
Class B dealers (NAICS 422990, other miscellaneous nondurable goods merchant wholesalers) are considered to be small if the entity employs 100 or fewer persons. According to the 1997 Census of Agriculture, more than 99 percent of these entities may be considered small. This rule will merely require Class B dealers to obtain a certification statement from unlicensed sellers, which is a small additional information collection requirement.
According to the SBA, Class C and registered exhibitors (NAICS 712130, zoos and botanical gardens, and NAICS 712190, nature parks and other similar institutions) are considered to be small if the entity has receipts of less than $5 million. According to the 1997 Economic Census, about 93 percent of these entities are considered small. There are over 2,500 exhibitors licensed by or registered with APHIS. However, we are unaware of any exhibitors who obtain dogs and/or cats from unlicensed individuals. Exhibitors who would deal with unlicensed individuals for dogs and/or cats would likely be small. However, this rule should have little impact on these exhibitors.
In 2002, there were more than 1,100 active animal research facilities in the United States. The SBA standard for a small research or testing facility is one with fewer than 500 employees (NAICS 5417102, research and development in life sciences). According to the 1997 Economic Census, at least 94 percent of the facilities in this category meet the standard to be considered small. However, these facilities should be affected by this rule in only minor ways. The new requirement for a certification statement from unlicensed sellers should not affect these facilities because they do not acquire random source dogs and cats from unlicensed sources.
In conclusion, we believe that the benefits of this rule, enhanced compliance with the AWA regulations, exceed the costs. While costs for some may increase—for example, the cost of random source animals used in research could increase because they become harder to obtain—we believe that the overall costs of this rule will be relatively small. License fees are relatively low, certifications can be provided quickly and easily, and information collection is a small addition to that already being collected. In addition, other changes should not alter the day-to-day operations of entities that are currently in compliance with the regulations. The primary benefit of the rule is enhanced animal welfare in keeping with the requirements of the AWA. Another benefit is a more competitive marketplace with clearer regulatory expectations.
An alternative to this rule would be to make no change to the animal welfare regulations. After consideration, we rejected this alternative because we believe this rule is necessary to ensure compliance with the regulations and the Animal Welfare Act.
This rule contains information collection requirements, which have been approved by the Office of Management and Budget (see “Paperwork Reduction Act” below). The effect of these information collection requirements is expected to be minimal, with the reporting burden for requesting reinspection and for certification of exemption from licensing both estimated to be 0.083 hours per response. The total estimated number of respondents is 500 and includes applicants, dealers, exhibitors, and research facilities.
In addition, we have not identified any relevant Federal rules that are currently in effect that duplicate, overlap, or conflict with this rule.
This program/activity is listed in the Catalogue 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 final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts all State and local laws and regulations that are inconsistent with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule.
In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The Animal and Plant Health Inspection Service is committed to compliance with the Government Paperwork Elimination Act (GPEA), which requires Government agencies in general to provide the public the option of submitting information or transacting business electronically to the maximum extent possible. For information pertinent to GPEA compliance related to this rule, please contact Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 734-7477.
Animal welfare, Pets, Reporting and recordkeeping requirements, Research.
7 U.S.C. 2131-2159; 7 CFR 2.22, 2.80, and 371.7.
7 U.S.C. 2131-2159; 7 CFR 2.22, 2.80, and 371.7.
(a) * * *
(3) * * *
(iii) Any person who maintains a total of three (3) or fewer breeding female dogs, cats, and/or small exotic or wild mammals, such as hedgehogs, degus, spiny mice, prairie dogs, flying squirrels, and jerboas, and who sells only the offspring of these dogs, cats, or small exotic or wild mammals, which were born and raised on his or her premises, for pets or exhibition, and is not otherwise required to obtain a license. This exemption does not extend to any person residing in a household that collectively maintains a total of more than three breeding female dogs, cats, and/or small exotic or wild mammals, regardless of ownership, nor to any person maintaining breeding female dogs, cats, and/or small exotic or wild mammals on premises on which more than three breeding female dogs, cats, and/or small exotic or wild mammals are maintained, nor to any person acting in concert with others where they collectively maintain a total of more than three breeding female dogs, cats, and/or small exotic or wild mammals regardless of ownership;
(iv) Any person who sells fewer than 25 dogs and/or cats per year, which were born and raised on his or her premises, for research, teaching, or testing purposes or to any research facility and is not otherwise required to obtain a license. This exemption does not extend to any person residing in a household that collectively sells 25 or more dogs and/or cats, regardless of ownership, nor to any person acting in concert with others where they collectively sell 25 or more dogs and/or cats, regardless of ownership. The sale of any dog or cat not born and raised on the premises for research purposes requires a license;
(c) A license will be issued to any applicant, except as provided in §§ 2.10 and 2.11, when:
(1) The applicant has met the requirements of this section and §§ 2.2 and 2.3; and
(2) The applicant has paid the application fee of $10 and the annual license fee indicated in § 2.6 to the appropriate Animal Care regional office for an initial license, and, in the case of a license renewal, the annual license fee has been received by the appropriate Animal Care regional office on or before the expiration date of the license.
(d)(1) A licensee who wishes a renewal must submit to the appropriate Animal Care regional office a completed application form and the annual license fee indicated in § 2.6 by certified check, cashier's check, personal check, money order, or credit card. The application form and the annual license fee must be received by the appropriate Animal Care regional office on or before the expiration date of the license. An applicant whose check is returned by the bank will be charged a fee of $20 for each returned check. A returned check will be deemed nonpayment of fee and will result in the denial of the license. If an applicant's check is returned, subsequent fees must be paid by certified check, cashier's check, or money order.
(2) A license fee indicated in § 2.6 must also be paid if an applicant is applying for a changed class of license. The applicant may pay the fee by certified check, cashier's check, personal check, money order, or credit card. An applicant whose check is returned by a bank will be charged a fee of $20 for each returned check. If an applicant's check is returned, subsequent fees must be paid by certified check, cashier's check, or money order.
(b)
(b) Each applicant for an initial license must be inspected by APHIS and demonstrate compliance with the regulations and standards, as required in paragraph (a) of this section, before APHIS will issue a license. If the first inspection reveals that the applicant's animals, premises, facilities, vehicles, equipment, other premises, or records do not meet the requirements of this subchapter, APHIS will advise the applicant of existing deficiencies and the corrective measures that must be completed to come into compliance with the regulations and standards. An applicant who fails the first inspection will have two additional chances to demonstrate his or her compliance with the regulations and standards through a second inspection by APHIS. The applicant must request the second inspection, and if applicable, the third inspection, within 90 days following the first inspection. If the applicant fails inspection or fails to request reinspections within the 90-day period, he or she will forfeit the application fee and cannot reapply for a license for a period of 6 months from the date of the failed third inspection or the expiration of the time to request a third inspection. Issuance of a license will be denied until the applicant demonstrates upon inspection that the animals, premises, facilities, vehicles, equipment, other premises, and records are in compliance with all regulations and standards in this subchapter.
(a) * * *
(4) The annual license fee has not been paid to the appropriate Animal Care regional office as required. There will not be a refund of the annual license fee if a license is terminated prior to its expiration date.
(b) Any person who is licensed must file an application for a license renewal and an annual report form (APHIS Form 7003), as required by § 2.7 of this part, and pay the required annual license fee. The required annual license fee must be received in the appropriate Animal Care regional office on or before the expiration date of the license or the license will expire and automatically terminate. Failure to comply with the annual reporting requirements or pay the required annual license fee on or before the expiration date of the license
(a) For an initial license, the applicant must submit a $10 application fee in addition to the initial license fee prescribed in this section. Licensees applying for license renewal or changed class of license must submit only the license fee prescribed in this section. The license fee for an initial license, license renewal, or changed class of license is determined from table 1 or 2 in paragraph (c) of this section. Paragraph (b) of this section indicates the method used to calculate the license fee. All initial license and changed class of license fees must be submitted to the appropriate Animal Care regional office, and, in the case of license renewals, all fees must be received by the appropriate Animal Care regional office on or before the expiration date of the license.
(c) The license fee shall be computed in accordance with the following tables:
(a) * * * No license will be renewed during the period that it is suspended. Renewal of the license may be initiated during the suspension in accordance with §§ 2.2(b) and 2.12.
(a) * * *
(4) Has pled
(5) Is or would be operating in violation or circumvention of any Federal, State, or local laws; or
(6) Has made any false or fraudulent statements or provided any false or fraudulent records to the Department or other government agencies, or has pled
(b) An applicant whose license application has been denied may request a hearing in accordance with the applicable rules of practice for the purpose of showing why the application for license should not be denied. The license denial shall remain in effect until the final legal decision has been rendered. Should the license denial be upheld, the applicant may again apply for a license 1 year from the date of the final order denying the application, unless the order provides otherwise.
(d) No license will be issued under circumstances that the Administrator determines would circumvent any order suspending, revoking, terminating, or denying a license under the Act.
A license may be terminated during the license renewal process or at any other time for any reason that an initial license application may be denied pursuant to § 2.11 after a hearing in accordance with the applicable rules of practice.
(c) No registrant or person required to be registered shall interfere with, threaten, abuse (including verbally abuse), or harass any APHIS official who is in the course of carrying out his or her duties.
(d) No research facility shall interfere with, threaten, abuse (including verbally abuse), or harass any APHIS official who is in the course of carrying out his or her duties.
(b) * * *
(8) If dogs or cats are acquired from any person not licensed or registered under the Act and not a pound or shelter, the research facility must obtain a certification that the animals were born and raised on the person's premises and that the person has sold fewer than 25 dogs and/or cats that year.
(k) * * *
(2) No person shall obtain live dogs or cats by use of false pretenses, misrepresentation, or deception.
(b) The use of a room, table, or other facilities necessary for the proper examination of the records and inspection of the property or animals must be extended to APHIS officials by the dealer, exhibitor, intermediate handler or carrier, and a responsible adult shall be made available to accompany APHIS officials during the inspection process.
(a) All licensees who maintain wild or exotic animals must demonstrate adequate experience and knowledge of the species they maintain.
(b) No person shall obtain live dogs, cats, or other animals by use of false pretenses, misrepresentation, or deception.
(d) No dealer or exhibitor shall knowingly obtain any dog, cat, or other animal from any person who is required to be licensed but who does not hold a current, valid, and unsuspended license. No dealer or exhibitor shall knowingly obtain any dog or cat from any person who is not licensed, other than a pound or shelter, without obtaining a certification that the animals were born and raised on that person's premises and, if the animals are for research purposes, that the person has sold fewer than 25 dogs and/or cats that year, or, if the animals are for use as pets, that the person does not maintain more than three breeding female dogs and/or cats.
National Aeronautics and Space Administration (NASA).
Final rule.
The National Aeronautics and Space Administration (NASA) is issuing a final rule to implement the “Federal Policy on Research Misconduct” (the Federal Policy) issued by the Executive Office of the President's Office of Science and Technology Policy on December 6, 2000. This rule will assist NASA in addressing allegations of research misconduct.
This rule is effective July 14, 2004.
Mayra N. Montrose, Office of the NASA Chief Scientist, at (202) 358-1492 (voice), (202) 358-3931 (fax).
The objective of the Federal Policy is to create a uniform policy framework for Federal agencies for the handling of allegations of misconduct in Federally funded or supported research. Within this framework, each Federal agency funding or supporting research is expected to fashion its own regulations to accommodate the various types of research transactions in which it is engaged.
In keeping with these objectives, on July 25, 2003, we published in the
NASA's research mission involves the advancement of research in the fields of aeronautics, space science, Earth science, biomedicine, biology, engineering, and physical sciences (physics and chemistry). NASA fulfills this objective through intramural research performed by NASA researchers and through extramural contracts, cooperative agreements, grants, and Space Act agreements with the private sector, and with other governmental entities. Because of this multiplicity of research arrangements, allegations of research misconduct could arise in any number of ways. In addition, the core principle of the Federal Policy is that while research institutions have the primary responsibility for the inquiry, investigation, and adjudication of allegations of research misconduct, Federal agencies have ultimate oversight authority for the research they fund or support. While there is some overlap in the actions that may be pursued by Federal agencies and research institutions, the rule is designed to provide procedures and criteria for the interaction of NASA with its research partners in dealing with the various contingencies that could arise in the processing of research misconduct allegations.
NASA shall amend 14 CFR part 1260 (Grants Handbook), 14 CFR part 1274 (Commercial agreements with cost sharing), and 48 CFR chapter 18 (NASA FAR Supplement), to reflect the implementation of this policy.
During the public comment period on the proposed rule (14 CFR part 1275) that ended on September 23, 2003, NASA received four comments on the proposed rule from interested parties. All four comments expressed concern regarding notification to NASA of the receipt of allegations by an institution. NASA agrees with this concern and is therefore requiring notification only when an allegation leads to an investigation (§1275.103(b)). Three of the comments concerned the lack of clarity in cases where multiple institutions are involved. NASA reworded the policy to clarify that in cases of multiple institutions, a designated lead organization will be primarily responsible for the investigation. Two of the comments requested clarification on NASA's review of a completed investigation prior to undertaking its own investigation (when deemed necessary). NASA accepts the comments and has added language to §1275.102(d) for clarity.
Two of the comments requested a description of the criteria used by NASA to initiate an investigation and accept or reject an institution's report. NASA modified §1275.103(b) to clarify when NASA needs to be notified of an investigation. NASA did not include the criteria that will be used to accept or reject an institution's report because such a list may limit the Agency's option to initiate such an investigation.
One comment suggested additional language in §1275.102(f) regarding the selection and funding of institutions under investigation. NASA accepted the language. Two comments requested that institutions be informed when NASA is conducting an investigation that affects them. NASA agreed and modified §§1275.102(e) and 1275.107(c). Three of the comments concerned the lack of distinction between policies and procedures governing extramural versus intramural researchers. NASA reviewed the rule and decided that the distinction is stated in §1275.102(a) and detailed in §§1275.104 and 105. Finally, one comment requested that the degree of confidentiality specified in the document is extreme. NASA thinks the language is appropriate and in accord with existing law. Other minor edits were also accepted.
This rule is a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order.
As required by the Regulatory Flexibility Act (5 U.S.C. 601-612), NASA has considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. NASA certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on small business entities.
This rule does not contain any information collection requirements subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. NASA has analyzed this rule under that Order and has determined that it does not have implications for federalism.
This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
This rule would not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Action and Interference with Constitutionally Protected Property Rights.
This rule meets applicable standards in section 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure in any 1 year of $100 million or more by a State, local, and tribal government in the aggregate, or by the private sector.
NASA certifies that this regulation will not compel the expenditure in any 1 year of $100 million or more by State, local, and tribal governments in the aggregate, or by the private sector. Therefore, the detailed statement under section 202 of the Unfunded Mandates Reform Act is not required.
Administrative practice and procedure, Grant programs, Investigations, Research, Science and technology, Scientists.
Pub. L. 85-568, 72 Stat. 426, 42 U.S.C. 2473.
(a) The purpose of this part is to establish procedures to be used by the National Aeronautics and Space Administration (NASA) for the handling of allegations of research misconduct. Specifically, the procedures contained in this part are designed to result in:
(1) Findings as to whether research misconduct by a person or institution has occurred in proposing, performing, reviewing, or reporting results from research activities funded or supported by NASA; and
(2) Recommendations on appropriate administrative actions that may be undertaken by NASA in response to research misconduct determined to have occurred.
(b) This part applies to all research wholly or partially funded or supported by NASA. This includes any research conducted by a NASA installation and any research conducted by a public or private entity receiving NASA funds or using NASA facilities, equipment or personnel, under a contract, grant, cooperative agreement, Space Act agreement, or other transaction with NASA.
(c) NASA shall make a determination of research misconduct only after careful inquiry and investigation by an awardee institution, another Federal agency, or NASA, and an adjudication conducted by NASA. NASA shall afford the accused individual or institution a chance to comment on the investigation report and a chance to appeal the decision resulting from the adjudication. In structuring procedures in individual cases, NASA may take into account procedures already followed by other entities investigating the same allegation of research misconduct. Investigation of allegations which, if true, would constitute criminal offenses, are not covered by this part.
(d) A determination that research misconduct has occurred must be accompanied by recommendations on appropriate administrative actions. However, the administrative actions themselves may be imposed only after further procedures described in applicable NASA regulations concerning contracts, cooperative agreements, grants, Space Act agreements, or other transactions, depending on the type of agreement used to fund or support the research in question. Administrative actions involving NASA civil service employees may be imposed only in compliance with all relevant Federal laws and policies.
(e) Allegations of research misconduct concerning NASA research may be transmitted to NASA in one of the following ways: by mail addressed to Office of Inspector General (OIG), Code W, National Aeronautics and Space Administration, 300 E Street, SW., Washington, DC 20546-0001; via the NASA OIG Hotline at 1-800-424-9183, or the NASA OIG cyber hotline at
(f) To the extent permitted by law, the identity of the Complainant, witnesses, or other sources of information who wish to remain anonymous shall be kept confidential. To the extent permitted by law, NASA shall protect the research misconduct inquiry, investigation, adjudication, and appeal records maintained by NASA as exempt from mandatory disclosure under 5 U.S.C. 552, the Freedom of Information Act, as amended, and 5 U.S.C. 552a, the Privacy Act, as amended.
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
(l)
(m)
(n)
(o)
(a) When an allegation is made to the OIG, rather than to the awardee institution, the OIG shall determine whether the allegation concerns NASA research and whether the allegation, if true, falls within the definition of research misconduct in § 1275.101(a). Investigation of allegations which, if true, would constitute criminal offenses, are not covered by this part. If these criteria are met and the research in question is being conducted by NASA researchers, the OIG shall proceed in accordance with § 1275.104. If the research in question is being conducted at an awardee institution, another Federal agency, or is a collaboration between NASA researchers and co-investigators at either academia or industry, the OIG must refer the allegation that meets the definition of research misconduct to the entities involved and determine whether to—
(1) Defer its inquiry or investigation pending review of the results of an inquiry or investigation conducted at the awardee institution or at the Federal agency (referred to for purposes of this part as
(2) Commence its own inquiry or investigation.
(b) The OIG must inform the NASA Office of the Chief Scientist of all allegations that meet the definition of research misconduct received by the OIG and of the determinations of the OIG required by §1275.101. The NASA Office of the Chief Scientist shall notify the NASA Office of the Chief Engineer or the NASA Office of the Chief Technologist when the research is either engineering or technology research.
(c) The OIG should defer its inquiry or investigation pending review of the results of an external investigation whenever possible. Nevertheless, the OIG retains the right to proceed at any time with a NASA inquiry or investigation. Circumstances in which the OIG may elect not to defer its inquiry or investigation include, but are not limited to, the following:
(1) When the OIG determines that the awardee institution is not prepared to handle the allegation in a manner consistent with this part;
(2) When the OIG determines that NASA involvement is needed to protect the public interest, including public health and safety;
(3) When the OIG determines that the allegation involves an awardee institution of sufficiently small size that it cannot reasonably conduct the investigation itself;
(4) When the OIG determines that a NASA program or project could be jeopardized by the occurrence of research misconduct; or
(5) When the OIG determines that any of the notifications or information required to be given to the OIG by the awardee institution pursuant to § 1275.103(b) requires NASA to cease its deferral to the awardee institution's procedures and to conduct its own inquiry or investigation.
(d) A copy of the investigation report, evidentiary record, and final determination resulting from an external investigation must be transmitted to the OIG for review. The OIG shall determine whether to recommend to the NASA Adjudication Official, or to the lead investigative organization in cases that involve multiple institutions, acceptance of the investigation report and final determination in whole or in part. The OIG's decision must be made within 45 days of receipt of the investigation report and evidentiary record. This period of time may be extended by the OIG for good cause. The OIG shall make this decision based on the OIG's assessment of the completeness of the investigation report, and the OIG's assessment of whether the investigating entity followed reasonable procedures, including whether the Respondent had an adequate opportunity to comment on the investigation report and whether these comments were given due consideration. If the OIG decides to recommend acceptance of the results of the external investigation, in whole or in part, the OIG shall transmit a copy of the final determination, the investigation report, and the evidentiary record to the NASA Adjudication Official, and to the NASA Office of the Chief Scientist. When the OIG decides not to recommend acceptance, the OIG must initiate its own investigation.
(e) In the case of an investigation conducted by the OIG, the OIG shall transmit copies of the investigation report, including the Respondent's written comments (if any), the evidentiary record and its recommendations, to the institution, to the NASA Adjudication Official and to the NASA Office of the Chief Scientist.
(f) Upon learning of alleged research misconduct, the OIG shall identify potentially implicated awards or proposals and, when appropriate, shall ensure that program, grant, or contracting officers handling them are informed. Neither a suspicion nor allegation of research misconduct, nor a pending inquiry or investigation, shall normally delay review of proposals. Subject to paragraph (g) of this section, reviewers or panelists shall not be informed of allegations or of ongoing inquiries or investigations in order to avoid influencing reviews. In the event that an application receives a fundable rating or ranking by a review panel, funding can be deferred by the program until the completion of the inquiry or investigation.
(g) If, during the course of an OIG conducted inquiry or investigation, it appears that immediate administrative action, as described in § 1275.106, is necessary to protect public health or safety, Federal resources or interests, or the interests of those involved in the inquiry or investigation, the OIG shall inform the NASA sponsor for the research and the NASA Office of the Chief Scientist.
(a) The awardee institutions have the primary responsibility for prevention and detection of research misconduct and for the inquiry, investigation, and adjudication of research misconduct alleged to have occurred in association with their own institutions, although NASA has ultimate oversight authority for NASA research.
(b) When an allegation of research misconduct related to NASA research is made directly to the OIG and the OIG defers to the awardee institution's inquiry or investigation, or when an allegation of research misconduct related to NASA research is made directly to the awardee institution which commences an inquiry or investigation, the awardee institution is required to:
(1) Notify the OIG if an inquiry supports a formal investigation as soon as this is determined.
(2) Keep the OIG informed during such an investigation.
(3) Notify the OIG immediately—
(i) If public health or safety is at risk;
(ii) If Federal resources, reputation, or other interests need protecting;
(iii) If research activities should be suspended;
(iv) If there is reasonable indication of possible violations of civil or criminal law;
(v) If Federal action is needed to protect the interests of those involved in the investigation; or
(vi) If the research community or the public should be informed.
(4) Provide the OIG with a copy of the investigation report, including the recommendations made to the awardee
(5) Provide the OIG with the awardee institution's final determination, including any corrective actions taken or planned.
(c) If an awardee institution wishes the OIG to defer its own inquiry or investigation, the awardee institution shall complete any inquiry and decide whether an investigation is warranted within 60 days. It should similarly complete any investigation, adjudication, or other procedure necessary to produce a final determination, within an additional 180 days. If completion of the process is delayed, but the awardee institution wishes NASA's deferral of its own procedures to continue, NASA may require submission of periodic status reports.
(d) Each awardee institution must maintain and effectively communicate to its staff, appropriate policies and procedures relating to research misconduct, including the requirements on when and how to notify NASA.
(a) When an awardee institution or another Federal agency has promptly initiated its own investigation, the OIG may defer its inquiry or investigation until it receives the results of that external investigation. When the OIG does not receive the results within a reasonable time, the OIG shall ordinarily proceed with its own investigation.
(b) When the OIG decides to initiate a NASA investigation, the OIG must give prompt written notice to the individual or institution to be investigated, unless notice would prejudice the investigation or unless a criminal investigation is underway or under active consideration. If notice is delayed, it must be given as soon as it will no longer prejudice the investigation or contravene requirements of law or Federal law-enforcement policies.
(c) When alleged misconduct may involve a crime, the OIG shall determine whether any criminal investigation is already pending or projected. If not, the OIG shall determine whether the matter should be referred to the Department of Justice.
(d) When a criminal investigation by the Department of Justice or another Federal agency is underway or under active consideration, the OIG shall determine what information, if any, may be disclosed to the Respondent or to NASA employees.
(e) To the extent possible, the identity of sources who wish to remain anonymous shall be kept confidential. To the extent allowed by law, documents and files maintained by the OIG during the course of an inquiry or investigation of misconduct shall be treated as investigative files exempt from mandatory public disclosure upon request under the Freedom of Information Act.
(f) When the OIG proceeds with its own inquiry, it is responsible for ensuring that the inquiry is completed within 60 days after it is commenced. The OIG may extend this period of time for good cause.
(g) On the basis of what the OIG learns from an inquiry, and in consultation as appropriate with other NASA offices, the OIG shall decide whether a formal investigation is warranted.
(a) The OIG shall make every reasonable effort to complete a NASA research misconduct investigation and issue a report within 120 days after initiating the investigation. The OIG may extend this period of time for good cause.
(b) A NASA investigation may include:
(1) Review of award files, reports, and other documents readily available at NASA or in the public domain;
(2) Review of procedures or methods and inspection of laboratory materials, specimens, and records at awardee institutions;
(3) Interviews with parties or witnesses;
(4) Review of any documents or other evidence provided by or properly obtainable from parties, witnesses, or other sources;
(5) Cooperation with other Federal agencies; and
(6) Opportunity for the Respondent to be heard.
(c) The OIG may invite outside consultants or experts to participate in a NASA investigation.
(d) During the course of the investigation, the OIG shall provide a draft of the investigation report to the Respondent, who shall be invited to submit comments. The Respondent must submit any comments within 20 days of receipt of the draft investigation report. This period of time may be extended by the OIG for good cause. Any comments submitted by the Respondent shall receive full consideration before the investigation report is made final.
(e) At the end of the investigation proceedings, an investigation report must be prepared that shall include recommended findings as to whether research misconduct has occurred. A recommended finding of research misconduct requires that:
(1) There be a significant departure from accepted practices of the relevant research community for maintaining the integrity of the research record;
(2) The research misconduct be committed intentionally, knowingly, or in reckless disregard of accepted practices; and
(3) The allegation be proven by a preponderance of evidence.
(f) The investigation report must also be transmitted with the recommendations for administrative action, when recommended findings of research misconduct are made. Section 1275.106 lists possible recommended administrative actions and considerations for use in determining appropriate recommendations.
(g) NASA OIG may elect to proceed with its administrative investigation processes in lieu of a research misconduct investigation under this part when the allegation is against a civil service employee (an intramural researcher).
(a) Listed in paragraphs (a)(1) through (a)(3) of this section are possible administrative actions that may be recommended by the investigation report and adopted by the adjudication process. They are not exhaustive, and are in addition to any administrative actions necessary to correct the research record. The administrative actions range from minimal restrictions (Group I Actions) to severe restrictions (Group III Actions), and do not include possible criminal sanctions.
(1) Group I Actions.
(i) Send a letter of reprimand to the individual or institution.
(ii) Require as a condition of an award that for a specified period of time an individual, department, or institution obtain special prior approval of particular activities from NASA.
(iii) Require for a specified period of time that an institutional official other than those guilty of research misconduct certify the accuracy of reports generated under an award or provide assurance of compliance with particular policies, regulations, guidelines, or special terms and conditions.
(2) Group II Actions.
(i) Restrict for a specified period of time designated activities or expenditures under an active award.
(ii) Require for a specified period of time special reviews of all requests for funding from an affected individual,
(3) Group III Actions.
(i) Immediately suspend or terminate an active award.
(ii) Debar or suspend an individual, department, or institution from participation in NASA programs for a specified period of time.
(iii) Prohibit participation of an individual as a NASA reviewer, advisor, or consultant for a specified period of time.
(b) In deciding what actions are appropriate when research misconduct is found, NASA officials should consider the seriousness of the misconduct, including, but not limited to:
(i) The degree to which the misconduct was knowing, intentional, or reckless;
(ii) Whether the misconduct was an isolated event or part of a pattern;
(iii) Whether the misconduct had a significant impact on the research record, research subjects, or other researchers, institutions, or the public welfare.
(a) The NASA Adjudication Official must review and evaluate the investigation report and the evidentiary record required to be transmitted pursuant to § 1275.102(d) and (e). The NASA Adjudication Official may initiate further investigations, which may include affording the Respondent another opportunity for comment, before issuing a decision regarding the case. The NASA Adjudication Official may also return the investigation report to the OIG with a request for further fact-finding or analysis.
(b) Based on a preponderance of the evidence, the NASA Adjudication Official shall issue a decision setting forth the Agency's findings as to whether research misconduct has occurred and recommending appropriate administrative actions that may be undertaken by NASA in response to research misconduct determined to have occurred. The NASA Adjudication Official shall render a decision within 30 days after receiving the investigation report and evidentiary record, or after completion of any further proceedings. The NASA Adjudication Official may extend this period of time for good cause.
(c) The decision shall be sent to the Respondent, to the Respondent's institution, and, if appropriate, to the Complainant. If the decision confirms the alleged research misconduct, it must include instructions on how to pursue an appeal to the NASA Appeals Official. The decision shall also be transmitted to the NASA Office of the Chief Scientist and the OIG.
(a) The Respondent may appeal the decision of the NASA Adjudication Official by notifying the NASA Appeals Official in writing of the grounds for appeal within 30 days after Respondent's receipt of the decision. If the decision is not appealed within the 30-day period, the decision becomes the final Agency action insofar as the findings are concerned.
(b) The NASA Appeals Official shall inform the Respondent of a final determination within 30 days after receiving the appeal. The NASA Appeals Official may extend this period of time for good cause. The final determination may affirm, overturn, or modify the decision of the NASA Adjudication Official and shall constitute the final Agency action insofar as the findings are concerned. The final determination shall also be transmitted to the NASA Office of the Chief Scientist and the OIG.
(c) Once final Agency action has been taken pursuant to paragraphs (a) or (b) of this section, the recommendations for administrative action shall be sent to the relevant NASA components for further proceedings in accordance with applicable laws and regulations.
Federal Trade Commission.
Final rule.
The Federal Trade Commission (Commission) announces new ranges of comparability for storage-type water heaters, gas-fired instantaneous water heaters, and heat pump water heaters. The Commission also announces that the current ranges of comparability required by the Appliance Labeling Rule (Rule) for room air conditioners, furnaces, boilers, and pool heaters will remain in effect until further notice.
Hampton Newsome, Attorney, Division of Enforcement, Federal Trade Commission, Washington, DC 20580 (202-326-2889).
The Rule was issued by the Commission in 1979, 44 FR 66466 (Nov. 19, 1979), in response to a directive in the Energy Policy and Conservation Act of 1975.
The Rule requires manufacturers of all covered appliances to disclose specific energy consumption or efficiency information (derived from the DOE test procedures) at the point of sale in the form of an “EnergyGuide” label and in catalogs. It also requires manufacturers of furnaces, central air conditioners, and heat pumps either to provide fact sheets showing additional cost information, or to be listed in an industry directory showing the cost information for their products. The Rule requires manufacturers to include, on labels and fact sheets, an energy consumption or
Section 305.8(b) of the Rule requires manufacturers, after filing an initial report, to report certain information annually to the Commission by specified dates for each product type.
Manufacturers have submitted data for room air conditioners, water heaters (including storage-type, gas-fired instantaneous, and heat pump water heaters), furnaces, boilers, and pool heaters. The ranges of comparability for water heaters have changed significantly this year. Accordingly, the Commission is amending the ranges in Appendices D1 through D5 of the Rule which cover storage-type water heaters (natural gas, propane, electric, and oil), gas-fired instantaneous water heaters, and heat pump water heaters. Water heater manufacturers should now base the disclosures of estimated annual operating costs required at the bottom of the EnergyGuides for these products on the 2004 Representative Average Unit Costs of Energy for electricity (8.60 cents per kiloWatt-hour), natural gas (91.0 cents per therm), propane ($1.23 per gallon), and/or heating oil ($1.28 per gallon) that were published by the Commission on April 30, 2004 (69 FR 23650).
The ranges of comparability for room air conditioners, furnaces, boilers, and pool heaters have not changed significantly enough to warrant a change to the current ranges. Therefore, the current ranges for these products will remain in effect until further notice. Manufacturers of room air conditioners must continue to use the corrected ranges for room air conditioners that were published on November 13, 1995 (60 FR 56945, at 56949). Manufacturers of room air conditioners must continue to base the disclosures of estimated annual operating cost required at the bottom of EnergyGuides for these products on the 1995 Representative Average Unit Costs of Energy for electricity (8.67 cents per kiloWatt-hour) that was published by the Commission on February 17, 1995 (60 FR 9295).
For up-to-date tables showing current range and cost information for all covered appliances, see the Commission's Appliance Labeling Rule Web page at
Advertising, Energy conservation, Household appliances, Labeling, Reporting and recordkeeping requirements.
42 U.S.C. 6294.
When the above ranges of comparability in Appendices D1 through D5 are used on EnergyGuide labels for water heaters, the estimated annual operating cost disclosure appearing in the box at the bottom of the labels must be derived using the 2004 Representative Average Unit Costs for electricity (8.60¢ per kiloWatt-hour), natural gas (91.0¢ per therm), propane ($1.23 per gallon, and heating oil ($1.28 per gallon) and the text below the box must identify the costs as such.
By direction of the Commission.
Mine Safety and Health Administration (MSHA), Labor.
Technical amendment; final rule.
This technical amendment updates the display of Office of Management and Budget (OMB) control numbers for MSHA's standards and regulations. This display assists the public search for current information on OMB control numbers for the information collection, recordkeeping,
July 14, 2004.
Marvin W. Nichols, Director; Office of Standards, Regulations, and Variances, MSHA; Phone: (202) 693-9440; FAX: (202) 693-9441; E-mail:
We (MSHA) first consolidated our listing of OMB control numbers in a final rule published on June 29, 1995 (60 FR 33719). This action codified the OMB control numbers for our standards and regulations in one location to assist the public in quickly determining whether OMB approved a specific information collection requirement. Table 1 in 30 CFR 3.1 displays the OMB control number for each section containing a requirement for the collection, reporting, recordkeeping, or dissemination of information. This display fulfills the requirements of 44 U.S.C. 3507(f) of the Paperwork Reduction Act of 1995 (PRA 95) which prohibits an agency from engaging in a collection of information without displaying its OMB control number. Under PRA 95, a person is not required to respond to a collection of information if a valid OMB control number is not displayed.
This revision updates our current display of OMB control numbers to include new control numbers approved by OMB for regulations completed since the last update and any changes made through the renewal of previously issued OMB control numbers. There are no substantive changes or renewals made to information collection requirements by this technical amendment.
Information collection requirements go through the public review process as part of the rule to which they apply. Likewise, the renewal of an OMB control number also requires public review. As a result, because of this prior notice and opportunity for public comment, we find that there is “good cause” under 5 U.S.C. 553(b)(B) of the Administrative Procedure Act (APA) to issue this technical amendment to Table 1 in 30 CFR Part 3 without additional public notice and comment.
We also determined that there is no need to delay the effective date. The technical amendment contains no new requirements for which the public would need time, beyond that provided for in the regulation itself, to plan compliance. We find, therefore, there is “good cause” to except this action from the 30-day delayed effective date requirement under 5 U.S.C. 553(b)(B) of the Administrative Procedure Act.
Mine safety and health, Reporting and recordkeeping requirements.
30 U.S.C. 957; 44 U.S.C. 3501-3520.
Department of Defense.
Final rule.
This document removes information in Title 32 of the Code of
Mr. G. McNamara (703) 602-4601.
The corresponding Department of Defense document, DoD Directive 1125.3 is available at
Blind, Concessions, Federal buildings and facilities.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing temporary security zones around the M/V ARGOSY VIRGINIA 5, M/V ARGOSY CELEBRATIONS ANDP/C OLYMPUS while underway, anchored, or moored on Lake Washington, Washington. In addition, the Coast Guard is establishing temporary security zones around Pier 70 and Amgen located on Elliott Bay and the National Oceanographic and Atmospheric Administration (NOAA) Sandpoint Facility and Gates Residence located on Lake Washington. Entry into these zones is prohibited unless authorized by the Captain of the Port, Puget Sound or his designated representatives. The Coast Guard is establishing these temporary security zones around these waterways and these vessels to provide safety and security during the National Governors Association (NGA) Conference. The Captain of the Port, Puget Sound, Washington is taking this action to safeguard the dignitaries, official parties, VIP's and other participants (“attendees”) attending the NGA Conference from terrorism, sabotage, or other subversive acts. Entry into these zones is prohibited unless authorized by the Captain of the Port.
This rule is effective from 11 a.m on July 17, through 2 a.m. on July 19 2004, unless sooner cancelled by the Captain of the Port.
Documents as indicated in this preamble are available for inspection or copying at the U.S. Coast Guard Marine Safety Office Puget Sound, 1519 Alaskan Way South, Building 1, Seattle, Washington 98134. Normal office hours are between 8 a.m. and 4 p.m., Monday through Friday, except federal holidays.
LTJG T.D. Thayer, c/o Captain of the Port Puget Sound, 1519 Alaskan Way South, Seattle, Washington 98134, (206) 217-6230.
We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
The Coast Guard is establishing temporary security zone regulations to safeguard designated vessels carrying NGA Conference attendees and the venue areas established for the attendees from potential terrorism, sabotage, or other subversive acts. These temporary security zones will mitigate these potential threats and are necessary to protect the public, conference attendees, law enforcement officers, maritime transportation infrastructure and the flow of commerce on these waterways. Representatives of the Captain of the Port Puget Sound, Washington will enforce these security zones. The Captain of the Port may be assisted by other federal, state and local agencies.
This Temporary Final Rule establishes moving security zones around certain vessels that will be used to transport conference attendees. This Temporary Final Rule also establishes security zones in the navigable waters of the United States around four different venues located on Elliott Bay and Lake Washington. These security zones will control vessel movements in and around these zones and they are necessary to safeguard the NGA Conference attendees from terrorism, sabotage, or other subversive acts. The security zones established by this Temporary Final Rule are as follows: (1) All waters of Lake Washington, Washington State, within a 200 yard radius centered on the M/V ARGOSY VIRGINIA 5, M/V ARGOSY CELEBRATIONS AND P/C OLYMPUS while these vessels are underway, anchored, or moored; (2) all waters of Elliott Bay, Washington, within a 200 yard radius centered on 47°37.6′ N, 122°22.5′ W, near the Amgen facility, which is located between Pier 90/91 and the grain terminal; (3) all waters of Elliott Bay, Washington , within a 200 yard radius centered on 47°36.88′ N, 122°21.45′ W, which is the approximate location of the end of Pier 70; (4) all waters of Lake Washington, Washington State, within a 200 yard radius centered on 47°41.3′ N, 122°15.8′ W, which is the location of National Oceanographic and Atmospheric Administration's Sandpoint Facility; and (5) all waters of Lake Washington, Washington State, south of the Highway 520 floating bridge, which are enclosed by following points: 47°37′758″ N, 122°14′554″ W; 47°37′758″ N, 122°14′680″ W; 47°37′572″ N, 122°14′610″ W; 47°37′575″ N, 122°14′679″ W [Datum: NAD 1983]. Entry into these security zones is prohibited unless authorized by the Captain of the Port.
This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory
Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule will affect the following entities, some of which may be small entities: The owners or operators of vessels intending to transit portions of Elliott Bay and Lake Washington. The security zone will not have a significant economic impact on a substantial number of small entities because of the limited areas these security zones cover and the short duration in time that they will be enforced. Because the impacts of this rule are so minimal, the Coast Guard certifies under 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule so that they can better evaluate its effects on them and participate in the rulemaking. If the rule will affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
This rule will not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.
The Coast Guard recognizes the rights of Native American Tribes under the Stevens Treaties. Moreover, the Coast Guard is committed to working with Tribal Governments to implement local policies to mitigate tribal concerns. We have determined that these security zones and fishing rights protection need not be incompatible. We have also determined that this Temporary Final Rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Nevertheless, Indian Tribes that have questions concerning the provisions of this Temporary Final Rule or options for compliance are encourage to contact the point of contact listed under
We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.
We have analyzed this rule under Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(g) of the Instruction, from further environmental documentation. A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” will be available in the docket where indicated under
Harbors, Marine safety, Navigation (water), Reporting and record keeping requirements, Security measures, Waterways.
33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 50 U.S.C. 191, 195; 33 CFR 1.05-1(g), 6.04-1, 6.04-6, and 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1.
(a)
(1)
(2)
(3)
(4)
(5)
(b)
(c)
Environmental Protection Agency (EPA).
Direct final rule; amendments.
We are amending the large municipal waste combustor (MWC) emission guidelines to add a carbon monoxide (CO) emission limit for one type of MWC technology that was not previously addressed. When the large MWC emission guidelines were developed, all existing MWC units using the fluidized bed, mixed fuel (wood/refuse-derived fuel) technology were judged to be small MWC units,
The direct final rule is effective September 13, 2004, unless significant material adverse comments are received by August 13, 2004. If we receive significant material adverse comments, we will publish a timely withdrawal of the direct final rule in the
The EPA has established a docket for this action under Docket ID No. OAR-2004-0007. All documents in the docket are listed in the EDOCKET index at
Mr. Walt Stevenson, Combustion Group, Emission Standards Division (C439-01), U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711, (919) 541-5264, e-mail
A companion proposal to the direct final rule is being published in today's
This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by the direct final rule. To determine whether your facility is regulated by the direct final rule, you should examine the applicability criteria in § 60.32b of subpart Cb, and § 62.14102 of subpart FFF. If you have any questions regarding the applicability of the direct final rule to a particular entity, contact the person listed in the preceding
The direct final rule amends the MWC emission guidelines and the MWC Federal plan for large MWC units to add a CO emission limit for bubbling fluidized bed combustors that burn a mixture of wood and refuse-derived fuel (RDF). This is the same combustor technology and CO emission limit that appear in the small MWC emission guidelines. In developing the emission guidelines for small MWC units, we recognized the unique characteristics of the existing bubbling fluidized bed MWC units combusting a mixture of wood and RDF and included a CO emission limit specific to that technology. Since promulgation of the emission guidelines for large MWC units, two existing fluidized bed MWC units combusting a mixture of wood and RDF were determined to be large MWC units, subject to the large MWC emission guidelines. However, the large MWC emission guidelines did not include bubbling fluidized bed MWC units combusting a mixture of wood and RDF because none were judged to be in the large category when the large MWC emission guidelines were developed and adopted in 1995. The direct final rule amendments recognize bubbling fluidized bed (wood/RDF) MWC units as an MWC technology in the large MWC category and add a CO emission limit of 200 ppm by dry volume (24-hour geometric mean). This is the same CO emission limit, and is based on the same analysis for this technology, that appears in the small MWC emission guidelines. The direct final rule amendments similarly revise the large MWC Federal plan, which implements the emission guidelines.
Under Executive Order 12866 (58 FR 51735, October 4, 1993), we must determine whether the regulatory action is “significant” and, therefore, subject to review by the Office of Management and Budget (OMB) and the requirements of the Executive Order. The Executive Order defines “significant regulatory action” as one that is likely to result in a rule that may:
(1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or
(2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;
(3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients thereof; or
(4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.
We have determined that the direct final rule is not a “significant regulatory action” under the terms of Executive Order 12866, and, therefore, is not subject to review by OMB because the final rule will not have an annual effect on the economy of $100 million or more and does not impose any additional control requirements above the 1995 emission guidelines. We considered the 1995 emission guidelines to be “significant,” and OMB reviewed them in 1995 (see 60 FR 65405, December 19, 1995).
This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501
Copies of the ICR document(s) may be obtained from Susan Auby by mail at U.S. EPA, Office of Environmental Information, Collection Strategies Division (2822T), 1200 Pennsylvania Avenue, NW., Washington, DC 20460, by email at
Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.
The Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996, 5 U.S.C. 601
For purposes of assessing the impacts of today's direct final rule on small entities, small entity is defined as follows: (1) A small business in the regulated industry that has a gross annual revenue less than $6 million; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; or (3) a small organization that is any not-for-profit enterprise that is independently owned and operated and is not dominant in its field.
Section 605 of the RFA requires Federal agencies to give special consideration to the impacts of regulations on small entities, which are small businesses, small organizations, and small governments. During the 1995 MWC rulemaking, EPA estimated that few, if any, small entities would be affected by the promulgated guidelines and standards and, therefore, a regulatory flexibility analysis was not required (see 60 FR 65413).
After considering the economic impacts of today's direct final rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. The direct final rule will not impose any requirements on small entities because it does not impose any additional regulatory requirements.
Title II of the Unfunded Mandates Reform Act (UMRA) of 1995, Public Law 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Under section 202 of the UMRA, we generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any 1 year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires us to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective, or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows us to adopt an alternative other than the least costly, most cost-effective, or least burdensome alternative if we publish with the final rule an explanation why that alternative was not adopted.
Before we establish any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, we must develop a small government agency plan under section 203 of the UMRA. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of our regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements.
We have determined that the final rule does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or the private sector in any 1 year. Thus,
Executive Order 13132 (64 FR 43255, August 10, 1999) requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.”
Under section 6 of Executive Order 13132, we may not issue a regulation that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, or we consult with State and local officials early in the process of developing the proposed regulation. Also, we may not issue a regulation that has federalism implications and that preempts State law, unless we consult with State and local officials early in the process of developing the proposed regulation.
The direct final rule does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. The direct final rule will not impose substantial direct compliance costs on State or local governments, it will not preempt State law. Thus, Executive Order 13132 does not apply to the final rule.
Executive Order 13175 (65 FR 67249, November 9, 2000) requires us to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have Tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.”
The direct final rule does not have tribal implications, as specified in Executive Order 13175. It will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to the direct final rule.
Executive Order 13045 (62 FR 19885, April 23, 1997) applies to any rule that: (1) Is determined to be “economically significant” as defined under Executive Order 12866, and (2) concerns an environmental health or safety risk that we have reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, we must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives we considered.
We interpret Executive Order 13045 as applying only to those regulatory actions that are based on health or safety risks, such that the analysis required under section 5-501 of the Executive Order has the potential to influence the regulation. The direct final rule is not subject to Executive Order 13045 because it is based on technology performance and not on health and safety risks. Also, the direct final rule is not “economically significant.”
The direct final rule is not subject to Executive Order 13211 (66 FR 43255, May 22, 2001) because it is not a significant regulatory action under Executive Order 12866.
Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d)(15 U.S.C. 272 note) directs us to use voluntary consensus standards in our regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (
The direct final rule does not involve technical standards. Therefore, the requirements of the NTTAA do not apply.
The Congressional Review Act, 5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Air pollution control, Intergovernmental relations, Reporting and recordkeeping requirements.
42 U.S.C. 7401
42 U.S.C. 7401-7671q.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Closure.
NMFS is prohibiting directed fishing for Pacific ocean perch in the Central Aleutian District of the Bering Sea and Aleutian Islands management area (BSAI). This action is necessary to prevent exceeding the 2004 total allowable catch (TAC) of Pacific ocean perch in this area.
Effective 1200 hrs, Alaska local time (A.l.t.), July 11, 2004, through 2400 hrs, A.l.t., December 31, 2004.
Josh Keaton, 907-586-7228.
NMFS manages the groundfish fishery in the BSAI exclusive economic zone according to the Fishery Management Plan for the Groundfish Fishery of the Bering Sea and Aleutian Islands Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.
The 2004 TAC specified for Pacific ocean perch in the Central Aleutian District of the BSAI is 2,706 metric tons (mt) as established by the 2004 harvest specifications for groundfish of the BSAI (69 FR 9242, February 27, 2004).
In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2004 TAC for Pacific ocean perch in the Central Aleutian District will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 2,100 mt, and is setting aside the remaining 606 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Pacific ocean perch in the Central Aleutian District of the BSAI.
This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA, (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such a requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of the directed fishery for Pacific ocean perch in the Central Aleutian District of the BSAI.
The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
This action is required by § 679.20 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
Environmental Protection Agency (EPA).
Proposed rule; amendments.
We are proposing to amend the large municipal waste combustor (MWC) emission guidelines to add a carbon monoxide (CO) emission limit for one type of MWC technology that was not previously addressed. When the large MWC emission guidelines were developed, all existing MWC units using the fluidized bed, mixed fuel (wood/refuse-derived fuel) technology were judged to be small MWC units,
In the Rule and Regulations section of today's
Submit your comments, identified by Docket ID No. OAR-2004-0007, by one of the following methods:
Mr. Walt Stevenson, Combustion Group, Emission Standards Division (C439-01), U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711, (919) 541-5264, e-mail
This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by the proposed rule. To determine whether your facility is regulated by the proposed rule, you should examine the applicability criteria in § 60.32b of 40 CFR part 60, subpart Cb, and § 62.14102 of 40 CFR part 62, subpart FFF. If you have any questions regarding the applicability of the proposed rule to a particular entity, contact the person listed in the preceding
The proposed rule amends the MWC emission guidelines and the MWC Federal plan for large MWC units to add a CO emission limit for bubbling fluidized bed combustors that burn a mixture of wood and refuse-derived fuel (RDF). This is the same combustor technology and CO emission limit that appear in the small MWC emission guidelines. In developing the emission guidelines for small MWC units, we recognized the unique characteristics of the existing bubbling fluidized bed MWC units combusting a mixture of wood and RDF and included a CO emission limit specific to that technology. Since promulgation of the emission guidelines for large MWC units, two existing fluidized bed MWC units combusting a mixture of wood and RDF were determined to be large MWC units, subject to the large MWC emission guidelines. However, the large MWC emission guidelines did not include bubbling fluidized bed MWC units combusting a mixture of wood and RDF because none were judged to be in the large category when the large MWC emission guidelines were developed and adopted in 1995. The proposed amendments recognize bubbling fluidized bed (wood/RDF) MWC units as an MWC technology in the large MWC category and add a CO emission limit of 200 ppm by dry volume (24-hour geometric mean). This is the same CO emission limit, and is based on the same analysis for this technology, that appears in the small MWC emission guidelines. The proposed amendments similarly revise the large MWC Federal plan, which implements the emission guidelines.
For a complete discussion of all of the administrative requirements of the proposed rule, see the direct final rule in the Rules and Regulations section of today's
The Regulatory Flexibility Act (RFA) as amended by the Small business Regulatory Enforcement Fairness Act (SBREFA) of 1996, 5 U.S.C. 601
For purposes of assessing the impacts of the proposed rule on small entities, small entity is defined as follows:
(1) A small business in the regulated industry that has a gross annual revenue less than $6 million;
(2) A small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; or
(3) A small organization that is any not-for-profit enterprise that is independently owned and operated and is not dominant in its field.
Section 605 of the RFA requires Federal agencies to give special consideration to the impacts of regulations on small entities, which are small businesses, small organizations, and small governments. During the 1995 MWC rulemaking, EPA estimated that few, if any, small entities would be affected by the promulgated guidelines and standards and, therefore, a regulatory flexibility analysis was not required (
After considering the economic impacts of today's proposed rule on small entities, I certify that the proposed rule will not have a significant economic impact on a substantial number of small entities. The proposed rule will not impose any requirements on small entities because it does not impose any additional regulatory requirements.
Environmental protection, Administrative practice and procedure, Air pollution control, Intergovernmental relations, Reporting and recordkeeping requirements.
Federal Communications Commission.
Proposed rule; extension of comment period.
In this document, the Consumer and Governmental Affairs Bureau grants a limited extension of the deadline for filing reply comments in CG Docket 04-208 on or before August 13, 2004, seeking comment on the NASUCA petition for declaratory ruling regarding truth-in-billing and billing formats for both wireline and wireless telecommunication carriers.
Comments are due on or before July 14, 2004, and reply comments are due on or before August 13, 2004.
Federal Communications Commission, 445 12th Street, SW., Washington, DC 20554.
Ruth Yodaiken or Kelli Farmer of the Consumer & Governmental Affairs Bureau at (202) 418-2512.
This is a summary of the Commission's
To request materials in accessible formats for people with disabilities
On May 25, 2004, the Commission released a
Accordingly,
National Highway Traffic Safety Administration (NHTSA), DOT.
Request for comments.
This notice announces the availability of a planning document that describes the scope and timeline of NHTSA's proposed research program addressing safety and fuel economy assessment of hydrogen-powered fuel cell and internal combustion engine vehicles.
Ensuring that hydrogen internal combustion engine (ICE) and fuel cell powered vehicles provide a level of safety comparable to that of other vehicles currently in use in the United States requires a substantial research effort. Hydrogen-powered vehicles will utilize many advanced and unique technologies that have not been tested in the transportation environment. Very little data are available concerning the safe performance of these vehicles because so few exist; they are typically prototypes handled by specially trained personnel. Many manufacturers, however, are substantially investing in producing and marketing these vehicles in the near future. As these vehicles are deployed into the fleet, the safety of hydrogen as a fuel and the safety of alternative fuel vehicles in crashes becomes an important issue for public safety. A failure to adequately address safety concerns in the earliest stages of development could have a negative impact on the deployment of this new technology.
Corollary efforts by NHTSA that are covered in the plan address fuel economy and international harmonization of global technical regulations for hydrogen vehicles. The agency will analyze the potential increases in the fleet fuel economy. NHTSA will also work with its international counterparts to determine the content of regulations pertaining to fuel cell and ICE hydrogen vehicles.
NHTSA seeks public review and comment on the planning document. Comments received will be evaluated and incorporated, as appropriate, into planned agency activities.
Comments should be submitted early enough to ensure that Docket Management receives them not later than October 12, 2004.
Interested persons may obtain a copy of the research plan by downloading the document from the Document Management System (DMS), U.S. Department of Transportation, at the address provided below, or from NHTSA's Web site at
• Web Site:
• Fax: (202) 493-2251.
• Mail: Docket Management Facility; U.S. Department of Transportation, 400 Seventh Street, SW., Nassif Building, Room PL-401, Washington, DC 20590-001.
• Hand Delivery: Room PL-401 on the plaza level of the Nassif Building, 400 Seventh Street, SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
• Federal eRulemaking Portal: Go to
The following persons at the National Highway Traffic Safety Administration, 400 Seventh Street, SW., Washington, DC 20590:
Barbara C. Hennessey, Office of Applied Vehicle Safety Research, NVS-320, telephone (202) 366-4714, e-mail
Interested persons are invited to submit comments in response to this request. We request that commenters provide all relevant factual information to support their conclusions or opinions, including statistical data and estimated cost and benefits, and the source of such information.
Comments must be written and in English. To ensure that your comments are correctly filed in the Docket, please include the docket number of this notice.
Comments must not be more than 15 pages long. (49 CFR 553.21). This limit was established to encourage comments written in a concise fashion. However, additional documents may be attached to your comments.
There is no limit on the length of the attachments.
Please submit two copies of comments, including the attachments, to Docket Management at the address given above under
If you wish Docket Management to notify you upon its receipt of your comments, mail a self-addressed, stamped postcard to Docket Management. Upon receiving your comments, Docket Management will return the postcard by mail.
If you wish to submit any information under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Chief Counsel, NHTSA, 400 7th St., SW., Washington, DC 20590. In addition, you should submit two copies of your comments, from which you have deleted the claimed confidential business information, to Docket Management at the address given above under
We will consider all comments that Docket Management receives before the close of business on the comment closing date indicated above under
You may read the comments received by Docket Management at the address given above under
• Go to the Docket Management System (DMS) Web page of the Department of Transportation (
• On that page, click on “search.”
• On the next page (
• On the next page, which contains docket summary information for the docket you selected, click on the desired comments. You may download the comments. Please note that even after the comment closing date, we will continue to file relevant information in the Docket as it becomes available. Since some people may submit late comments, we recommend that you periodically check the Docket for new material.
49 U.S.C. 322, 30111, 30115, 30117, and 30166; delegation of authority at 49 CFR 1.50.
Fish and Wildlife Service, Interior.
Correction to proposed regulations.
This document contains corrections to the proposed regulations which were published June 30, 2004 (69 FR 39552). The proposed regulations related to the addition of 10 refuges and wetland management districts to the list of areas open for hunting and/or sport fishing programs and increase the activities available at 7 other refuges. We also develop pertinent refuge-specific regulations for those activities and amend certain regulations on other refuges that pertain to migratory game bird hunting, upland game hunting, big game hunting, and sport fishing for the 2004-2005 season.
Leslie Marler, (703) 358-2397.
We must receive your comments on or before July 30, 2004.
We issue refuge-specific regulations when we open wildlife refuges to migratory game bird hunting, upland game hunting, big game hunting, or sport fishing. These regulations list the wildlife species that you may hunt or fish, season, bag or creel limits, methods of hunting or sport fishing, descriptions of areas open to hunting or sport fishing, and other provisions as appropriate. The regulations that are the subject of these corrections increase opportunity to hunt migratory game birds at two refuges in the State of Tennessee.
We provided information in the
Accordingly, the publication on June 30, 2004, of the proposed regulations is corrected as follows:
1. The listing for Cross Creeks National Wildlife Refuge on page 39661 in the first column in § 32.62, under A. Migratory Game Bird Hunting [Reserved], is corrected as follows:
1. The refuge is a day-use area only, with the exception of legal hunting/fishing activities.
2. You must possess and carry a valid refuge permit while hunting on the refuge.
3. We set and publish season dates and bag limits annually in the refuge Public Use Regulations available at the refuge office.
4. We prohibit hunting within 50 yards (45 m) of any building, public use road, or boat launching ramp.
5. We allow hunters access to the refuge from 1
6. We prohibit the use of motorized off-road vehicles (
7. We prohibit the use of horses or other animal conveyances on refuge hunts.
8. Youth hunters under age 16 must remain in sight and normal voice contact with an adult hunter age 21 or older. One adult hunter may supervise no more than two youth hunters.
9. We allow the use of dogs to retrieve geese.
10. You may use only portable blinds, and you must remove all boats, blinds, and decoys from the refuge at the end of each day.
2. The listing for Tennessee National Wildlife Refuge on page 39662 in the third column in § 32.62, under A. Migratory Game Bird Hunting [Reserved], is corrected as follows:
1. The refuge is a day-use area only, with the exception of legal hunting/fishing activities.
2. We require a refuge hunt permit for all hunters age 16 and older. We charge a fee for all hunt permits. You must possess and carry a valid refuge permit while hunting on the refuge.
3. We set and publish season dates and bag limits annually in the refuge Public Use Regulations available at the refuge office.
4. We prohibit hunting within 50 yards (45 m) of any building, public use road, or boat launching ramp.
5. We allow access for goose hunting on the refuge 1
6. We prohibit the use of motorized off-road vehicles (
7. We prohibit the use of horses or other animal conveyances on refuge hunts.
8. Youth hunters under age 16 must remain in sight and normal voice contact with adult hunters age 21 or older. One adult hunter may supervise no more than two youth hunters.
9. We allow the use of dogs to retrieve geese.
10. You may use only portable blinds, and you must remove all boats, blinds, and decoys from the refuge at the end of each day.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of availability; request for comments.
The North Pacific Fishery Management Council (Council) has submitted Amendment 48 to the Fishery Management Plan (FMP) for Groundfish of the Gulf of Alaska (GOA) and Amendment 48 to the FMP for the Groundfish Fishery of the Bering Sea and Aleutian Islands (BSAI) (Amendments 48/48). If approved, Amendments 48/48 would revise the administrative process used to establish annual harvest specifications for the groundfish fisheries of the GOA and the BSAI and would update the FMPs by revising the description of the groundfish fisheries and participants, revising the name of the BSAI FMP, revising text to simplify wording and correct typographical errors, and revising the description of the Council's Groundfish Plan Teams' responsibilities. This action is necessary to manage fisheries based on the best scientific information available, to provide for adequate prior public review and comment to the Secretary of Commerce (Secretary) on Council recommendations, to provide for additional opportunity for Secretarial review, to minimize unnecessary disruption to fisheries and public confusion, and to promote administrative efficiency. This action is intended to promote the goals and objectives of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), the FMPs, and other applicable laws.
Comments on Amendments 48/48 must be submitted by September 13, 2004.
Send comments to Sue Salveson, Assistant Regional Administrator, Sustainable Fisheries Division, Alaska Region, NMFS, Attn: Lori Durall. Comments may be submitted by:
• Mail to P.O. Box 21668, Juneau, AK 99802;
• Hand Delivery to the Federal Building, 709 West 9th Street, Room 420A, Juneau, AK;
• E-mail to
• FAX to 907-586-7557; or
• Webform at the Federal eRulemaking Portal: www.regulations.gov. Follow the instructions at that site for submitting comments.
Copies of the Environmental Assessment/Regulatory Impact Review/Initial Regulatory Flexibility Analysis (EA/RIR/IRFA) prepared for Amendments 48/48 and the amendments may be obtained from the same mailing address above or from the
Melanie Brown, 907-586-7228 or
The Magnuson-Stevens Act requires that each Regional Fishery Management Council submit any FMP amendment it prepares to NMFS for review and approval, disapproval, or partial approval. The Magnuson-Stevens Act also requires that NMFS, upon receiving an FMP amendment, immediately publish a notice in the
Amendments 48/48 were unanimously recommended by the Council in October 2003. If approved by NMFS, these amendments would revise the administrative process used to establish annual harvest specifications for the groundfish fisheries of the BSAI and GOA. Harvest specifications establish specific limits on the commercial harvest of groundfish and are used to manage the groundfish fisheries. Harvest specifications include total allowable catch (TAC), acceptable biological catch (ABC), overfishing levels, and prohibited species catch (PSC) amounts, and apportionments thereof, which have been recommended by the Council. Currently, the regulations provide for annual harvest specifications that are effective January 1 through December 31. The goals in revising the harvest specifications process are to: (1) manage fisheries based on the best scientific information available, (2) provide for adequate prior public review and comment to the Secretary on Council recommendations, (3) provide for additional opportunity for Secretarial review, (4) minimize unnecessary disruption to fisheries and public confusion, and (5) promote administrative efficiency.
The current harvest specifications process requires publication of proposed, interim, and final rulemaking. Each October, the Council recommends proposed harvest specifications to NMFS which are reviewed and published in the
Starting in January of the new fishing year, groundfish fisheries are managed using interim harvest specifications, pending publication of the final harvest specifications. These interim harvest specifications remain in place until superseded by final harvest specifications in February or March each year. The interim harvest specifications are required by § 679.20(c)(2) to be 25 percent or the first seasonal apportionment of the proposed TAC amounts for most groundfish target species and 25 percent of the proposed PSC amounts.
A number of statutory requirements must be met by NMFS to implement annual harvest specifications. Section 553(c) of the Administrative Procedure Act (APA) requires prior public review and comment on a proposed rule, including review and comment on the information used as the basis for the proposed rule, unless the prior opportunity for public review is waived pursuant to section 553(b)(3)(B) of the APA. National standard 2 in section 301(a)(2) of the Magnuson-Stevens Act requires the management of the groundfish fisheries to be based on the best scientific information available. Each year in October, proposed harvest specifications for the following year are developed based on either TAC amounts used in the current year for some species or on projections from the Stock Assessment and Fishery Evaluation (SAFE) reports written the previous year. The SAFE reports written in the previous year often are the best scientific information available in October for supporting the harvest specifications for the following year. The new SAFE reports completed in November are used by the Council to recommend final harvest specifications in mid-December, usually after publication in the
The proposed and final specifications process normally requires 6 months to complete, yet only 2 weeks exist between the time the new final SAFE reports are available (mid-December) and the start of the fishing year on January 1. The Council's Groundfish Plan Teams develop the SAFE reports in November for the following fishing year based on the summer survey data and new analysis. These November SAFE reports are reviewed and approved by the Council in December and used as the scientific basis for its recommended harvest specifications. Because of this time constraint, the proposed harvest specifications are completed before the new information supporting the final harvest specifications is available. The proposed harvest specifications and supporting information available for public review and comment can differ from the final harvest specifications and their supporting information.
For some species, the harvest specifications change little among years, such as TAC amounts for certain long-lived target groundfish species in the GOA. For other species, harvest specifications can change greatly between the proposed and final harvest specifications for various reasons. In some cases, adjustments are made based on the new information developed in the November SAFE reports. In the BSAI, the need to maximize the harvest of a particular groundfish species can cause changes between proposed and final TACs for a number of groundfish species to maintain the overall harvest at or below the 2 million optimal yield specified at § 679.20(a)(1)(i). Because the proposed harvest specifications and supporting information can differ from the final harvest specifications and information on which they are based, the current specifications process raises concerns that it may not provide adequate opportunity for prior public review and comment on the annual harvest specifications or on the supporting information used for the annual harvest specifications.
The use of interim specifications in the current specifications process also is problematic. Prior public review and comment on the interim specifications has been routinely waived for “good cause” pursuant to section 553(b)(B) of the APA. However, this practice raises serious questions of compliance with the APA's notice and comment requirements. See
Amendments 48/48 would provide a process that allows for adequate prior public review and comment on the harvest specifications and supporting information and would allow the groundfish fisheries to be managed based on the best available scientific information. Each year in October, the Council would recommend to NMFS proposed harvest specifications that would be effective for up to 2 years. The rationale for harvest specifications that would be effective for up to 2 years is explained later in this document.
In consideration of the current stock assessment survey schedules, regulatory
If the final harvest specifications recommendations are not a logical outgrowth of the proposed harvest specifications, an additional publication of proposed harvest specifications may be needed to provide an additional opportunity for prior public review and comment under the APA. In May or June of the following year, the final harvest specifications would be published based on the additional proposed harvest specifications and after consideration of public comment. Alternatively, depending upon the circumstances, NMFS may find “good cause” to waive the additional publication of proposed harvest specifications for prior public review and comment. In this case, the final harvest specifications likely would become effective in March.
To provide opportunity for an additional public comment period after the Council's final harvest specifications recommendation in December, the groundfish fisheries in the new fishing year would be managed on the specifications that had been published previously. These harvest specifications would be superseded by the new harvest specifications. This proposed specifications process would eliminate the need for the interim harvest specifications. Having harvest specifications effective into the second fishing year would allow time for NMFS to complete an additional public review and comment period, if needed, while preventing disruption of the fisheries.
To provide consistency between the groundfish FMPs for the harvest specifications process and to provide flexibility during the harvest specifications process, Amendments 48/48 would allow specifications to be effective for up to 2 fishing years. The stock assessment models used for determining the harvest specifications would use 2-year projections for biomass and acceptable biological catch. The frequency of fishery resource surveys also affects whether specifications should be done on a more or less frequent basis. Allowing specifications to be effective for up to 2 years would fit well with the frequency of stock projections that must be used for the harvest specifications, and would provide the Council and NMFS the flexibility to adjust the specifications time periods in response to potential changes in the frequency of stock assessment surveys or other stock assessment data or administrative issues.
The Council recommended that harvest specifications for the hook-and-line gear and pot gear sablefish individual fishing quota (IFQ) fisheries be limited to the succeeding fishing year to ensure those fisheries are conducted concurrent with the halibut IFQ fishery. Having the sablefish IFQ fisheries concurrent with the halibut IFQ fishery would reduce the potential for discards of halibut and sablefish in these fisheries. The sablefish IFQ fisheries would remain closed at the beginning of each fishing year, until the final harvest specifications for the sablefish IFQ fisheries are in effect. The trawl sablefish fishery would be managed using harvest specifications for up to 2 years with the remaining target species in the BSAI and with GOA pollock, Pacific cod, and the “other species” complex.
Amendment 48 to the BSAI FMP would revise the title of the FMP. The GOA FMP title is a more concise description of the document compared to the title used for the BSAI FMP. Definitions at 50 CFR 679.2 describe the BSAI as the “Bering Sea and Aleutian Islands management area.” Consistency between the names of the groundfish FMPs and with the groundfish fishery regulations would reduce confusion for users of the documents. The BSAI FMP title would be revised to “The Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area.” Catch histories and the socioeconomic and community descriptions also would be updated with more recent information. References supporting the descriptions would be added to the reference section of the FMP.
The GOA and BSAI FMPs contain references related to the management of foreign vessels and foreign processors in the groundfish fisheries. Foreign participation in the groundfish fisheries in the Exclusive Economic Zone off Alaska ended in 1990. Amendments 48/48 would revise the text throughout the FMPs to revise references to the management of foreign fishing vessels and foreign processors.
The description in the FMPs of the responsibilities of the Council's Groundfish Plan Teams would be revised with this action. The current FMPs require the Plan Teams to provide preliminary SAFE reports annually for the September Council meeting and to include PSC apportionments and allocations recommendations and economic analysis. The Council meeting was moved to October, and preliminary SAFEs are no longer developed by the Plan Teams. No information is available to the Plan Teams to allow recommendations of PSC apportionments and allocations. This information is usually available at the October and December Council meetings. No economists are on the Plan Teams, so an economic analysis cannot be produced by the Plan Teams for the October Council meeting. The amendments would revise the FMPs to limit the Plan Teams' responsibilities for the annual October Council meeting to providing the most recent information regarding proposed ABC amounts and overfishing levels to the Council. The amendments also would revise the FMP so that the Council may request the Plan Teams to recommend PSC allocations and apportionments among target fisheries and gear types and an economic analysis on the affects of such allocations. This revision would provide flexibility in the future, if the Plan Teams were to include an economist.
The information regarding skates in the GOA FMP would be updated with this action. In 2003, a directed fishery for skates developed in the GOA, targeting big and longnose skate species. The current FMP language does not list big and longnose skate species in the description of skates, and describes the harvest of skates as bycatch only. This action would update the fishery information regarding skates to identify species taken and the methods of
Amendments 48/48 also would revise the text in the GOA and BSAI FMPs to correct typographical errors and to clarify wording.
Public comments are being solicited on proposed Amendments 48/48 through the end of the comment period (see
Department of Commerce (DOC), National Oceanic and Atmospheric Administration (NOAA).
Notice.
NOAA publishes this notice to amend the agency's solicitation for applications published on June 30, 2004, in an action entitled “Omnibus Notice Announcing the Availability of Grant Funds for Fiscal Year 2005.” In this notice, NOAA adds five programs that are making funds available for financial assistance awards. Interested applicants should consult the June 30, 2004, notice for all of the other requirements for submitting an application.
Proposals must be received by the date and time indicated under each program listing in the
Proposals must be submitted to the addresses listed in the
For a copy of the prior published Omnibus
In this notice, NOAA adds five programs that are making funds available for financial assistance awards. Interested applicants should consult the June 30, 2004 (69 FR 39417) notice for all of the other requirements for submitting an application. This omnibus notice describes funding opportunities for the following NOAA discretionary grant programs:
Summary Description: The NMFS Southeast Regional Office is inviting the public to submit research and development projects that will optimize the use of fisheries in the Gulf of Mexico and off the South Atlantic states of North Carolina, South Carolina, Georgia, and Florida involving the U.S. fishing industry (recreational and commercial), including fishery biology, resource assessment, socioeconomic assessment, management and conservation, selected harvesting methods, and fish handling and processing. Proposals may be selected for funding for up to three years through a cooperative agreement.
Funding Availability: Approximately $2.5 million may be available in fiscal year (FY) 2005 for projects. This amount includes possible in-house projects. The NMFS Southeast Regional Office anticipates that typical project awards will range from $30,000 to $300,000. The average award is $78,950.
Statutory Authority: We are soliciting applications for Federal assistance pursuant to 15 U.S.C. 713c-3(d).
CFDA: 11.433 Marine Fisheries Initiative.
Application Deadline: We must receive your application by close of business (5 p.m. eastern daylight time) on August 30, 2004. Applications will be date stamped to show date and time received. Applications received after that time will not be considered for funding.
Address for Submitting Proposals: You can obtain an application package from, and send your completed application(s) to: National Marine Fisheries Service, State/Federal Liaison office, 9721 Executive Center Drive N., St. Petersburg, FL 33702. You may also obtain the application package from the MARFIN Home Page at:
Information Contact(s):Ellie Francisco Roche, Chief, State/Federal Liaison Office at (727) 570-5324.
Eligibility: Eligible applicants include: Institutions of higher education, other nonprofits, commercial organizations, state, local and Indian tribal governments. Federal agencies or institutions are not eligible. Foreign governments, organizations under the jurisdiction of foreign governments, and international organizations are excluded for purposes of this solicitation since the objective of the MARFIN program is to optimize research and development benefits from U.S. marine fishery resources.
Cost Sharing Requirements: Cost-sharing is not required.
Intergovernmental Review: Applications under this program are subject to Executive Order 12372, “Intergovernmental Review of Federal Programs.”
Summary Description: The NMFS Southeast Regional Office is inviting the public to submit research and development projects that seek to increase and improve the working relationship between researchers from
Funding Availability: Approximately $2.0 million may be available in fiscal year (FY) 2005 for projects. The NMFS Southeast Regional Office anticipates that typical project awards will range from $45,000 to $480,000. The average award is $190,000.
Statutory Authority: We are soliciting applications for Federal assistance pursuant to 15 U.S.C. 713c-3(d).
CFDA: 11.454 Unallied Management Projects.
Application Deadline: We must receive your application by close of business (5 p.m. eastern daylight time) on September 13, 2004. Applications will be date stamped to show date and time received. Applications received after that time will not be considered for funding.
Address for Submitting Proposals: You can obtain an application package from, and send your completed application(s) to: National Marine Fisheries Service, State/Federal Liaison office, 9721 Executive Center Drive N., St. Petersburg, FL 33702. You may also obtain the application package from the CRP homepage at:
Information Contact(s):Ellie Francisco Roche, Chief, State/Federal Liaison Office at (727) 570-5324.
Eligibility: Eligible applicants include: Institutions of higher education, other nonprofits, commercial organizations, state, local and Indian tribal governments and individuals. Federal agencies or institutions are not eligible. Foreign governments, organizations under the jurisdiction of foreign governments, and international organizations are excluded for purposes of this solicitation since the objective of the CRP is to optimize research and development benefits from U.S. marine fishery resources.
Applicants who are not commercial or recreational fisherman must have commercial or recreational fishermen participating in their project. There must be a written agreement with a fisherman describing the involvement in the project activity.
Cost Sharing Requirements: Cost-sharing is not required.
Intergovernmental Review: Applications under this program are subject to Executive Order 12372, “Intergovernmental Review of Federal Programs.”
Summary Description: NOAA, the U.S. Fish and Wildlife Service, and the U.S. Maritime Administration expect to entertain proposals to conduct ballast water treatment technology testing and demonstration projects. The Ballast Water Technology Demonstration Program supports projects to develop, test, and demonstrate technologies that treat ships' ballast water in order to reduce the threat of introduction of aquatic invasive species to U.S. waters through the discharge of ballast water.
Funding Availability: Depending on 2005 appropriations, NOAA and the U.S. Fish and Wildlife Service expect to make available up to about $2 million in FY 2005, and the U.S. Maritime Administration expects to make available several vessels for use as test platforms, support ballast water treatment technology demonstration projects. The maximum amount of award will vary with the scale of the proposed project. If $2 million is made available, approximately 8 grants with a median value of about $200,000 are anticipated to be awarded.
Statutory Authority: Statutory authority for this program is provided under 16 U.S.C. 4701
Catalog of Federal Domestic Assistance (CFDA) Number: 11.417, Sea Grant Support; 15.FFA Fish and Wildlife Management Assistance.
Application Deadline: Pre-proposals must be received by the National Sea Grant Office by 4 p.m. EDT on August 27, 2004, and by 4 p.m. EST on November 16, 2004 for full proposals.
Addresses for Submitting Proposals: Pre-proposals and full proposals must be submitted to the National Sea Grant Office, Attn: Mrs. Geraldine Taylor, SG-Ballast Water, 1315 East-West Highway, R/SG, Rm 11732, Silver Spring, MD 20910. Telephone number for express mail applications is 301-713-2445.
Information Contact(s): Dorn Carlson, NOAA National Sea Grant Office, 301-713-2435; via internet at Dorn.Carlson@noaa.gov; or Pamela Thibodeaux, U.S. Fish and Wildlife Service, 703-358-2493; via internet at Pamela_Thibodeaux@fws.gov; or Deborah Aheron, U.S. Maritime Administration, 202-366-8887; via internet at Deborah.Aheron@marad.dot.gov. Further information can be obtained from the above information contacts, or on the Ballast Water Program website,
Eligibility: Individuals, institutions of higher education, nonprofit organizations, commercial organizations, Federal, State, local and Indian tribal governments, foreign governments, organizations under the jurisdiction of foreign governments, and international organizations are eligible. Only those who submit pre-proposals by the deadline are eligible to submit full proposals.
Cost Sharing Requirements: None.
Intergovernmental Review: Applications under this program are not subject to Executive Order 12372, “Intergovernmental Review of Federal Programs.”
Summary Description: The National Sea Grant College Program seeks to fund research and outreach projects addressing the introduction and spread of aquatic invasive species. The goal of the program is to discover and develop information and tools that can lead to the prevention, monitoring and control of aquatic invasive species threatening United States coastal, oceanic and Great Lakes communities, resources and ecosystems. Appropriate areas of research may include: biology and life history research, population dynamics, genetics, physiology, behavior, and parasites and diseases of nonindigenous species, ecological and environmental tolerances of nonindigenous species, impacts of invasive species at each stage of their life history on the environment, resources, and human health, research into invasive species control measures (engineering, physical, chemical, biological, physicochemical, administrative, and educational), and economic impact analysis of invasive species on marine and coastal resources, sport, commercial and tribal fisheries, the recreation and tourism industry, the shipping and navigation industry, and municipal and industrial water users. Other appropriate areas of endeavor may include: use of research results to provide a scientific basis for developing sound policy and environmental law, public education and technology transfer, research and outreach into identifying vectors of ANS introduction, and education and outreach activities that will transfer this information to the appropriate users.
Funding Availability: Depending on the overall funding appropriation for the
Statutory Authority: Statutory authority for this program is provided under 33 U.S.C. 1121-1131.
Catalog of Federal Domestic Assistance (CFDA) Number: 11.417, Sea Grant Support.
Application Deadline: Pre-proposals must be received by a state Sea Grant Program (or by the National Sea Grant Office in the case of an applicant in a non-Sea Grant state) by 4 p.m. (local time) on August 27, 2004, and by 4 p.m. (local time) on November 16, 2004 for full proposals. State Sea Grant Programs are to forward all proposals received by the above deadlines to the National Sea Grant Office by 4 p.m. EDT on September 2, 2004 and full-proposals by 4 p.m. EST November 23, 2004.
Addresses for Submitting Proposals: Pre-proposals and full proposals from Sea Grant states must be submitted to the state Sea Grant Program. The addresses of the state Sea Grant Programs may be found at
Information Contact(s): Dorn Carlson, NOAA National Sea Grant Office, 301-713-2435; via internet at
Eligibility: Individuals, institutions of higher education, nonprofit organizations, commercial organizations, State, local and Indian tribal governments, foreign governments, and international organizations are eligible. Only those who submit pre-proposals by the deadline are eligible to submit full proposals.
Cost Sharing Requirements: Applicants are required to provide one dollar non-Federal funds for every two dollars of Federal funds.
Intergovernmental Review: Applications under this program are not subject to Executive Order 12372, “Intergovernmental Review of Federal Programs.”
Summary Description: The NWS is soliciting requests to provide capital funds for the creation, refurbishment, or replacement of Automated Flood Warning Systems (AFWS). The IFLOWS Program is a joint undertaking by the National Weather Service (NWS) and participating States to improve flood warning capabilities. The NWS provides technical support and funds for initial capital and installation costs for equipment, life-cycle equipment replacement or upgrading in coming years, software development, and centralized forecast and analysis activities.The expected period of performance is for one year with an anticipated start date of April 1, 2005. NOAA/NWS will partner with entities that can demonstrate a long-term ability to operate and maintain an AFWS and provide the data to the NWS.
Funding Availability: Approximately $500,000 will be available through this announcement for fiscal year 2005. Proposals should be prepared assuming an annual budget of no more than $100,000.Statutory Authority: 15 USC 313; 33 USC 883d; 49 USC 44720 (b). CFDA: 11.450, Integrated Flood Observing and Warning System.
Application Deadline: Proposals must be received by the NWS no later than 5 P.M., local time, October 21, 2004.
Address for Submitting Proposals: NOAA/NWS; 1325 East-West Highway, Room 13396; Silver Spring, Maryland 20910-3283.
Information Contact(s): John Bradley, NOAA/NWS; 1325 East-West Highway, Room 13396; Silver Spring, Maryland 20910-3283, or by phone at 301-713-0624 ext. 154, or fax to 301-713-1520, or via internet at john.bradley@noaa.gov.
Eligibility: Eligible applicants are institutions of higher education, other nonprofits, and, state, local and Indian tribal governments.
Cost Sharing Requirements: None. However, applicant resource commitment will be considered in the competitive selection process.
Intergovernmental Review: Applications under this program are not subject to Executive Order 12372, “Intergovernmental Review of Federal Programs.”
Funding for programs listed in this notice is contingent upon the availability of Fiscal Year 2005 appropriations. Applicants are hereby given notice that funds have not yet been appropriated for the programs listed in this notice. In no event will NOAA or the Department of Commerce be responsible for proposal preparation costs if these programs fail to receive funding or are cancelled because of other agency priorities. Publication of this announcement does not oblige NOAA to award any specific project or to obligate any available funds.
Applicants should be aware that, they are required to provide a Dun and Bradstreet Data Universal Numbering System (DUNS) number during the application process. See the October 30, 2002
NOAA must analyze the potential environmental impacts, as required by the National Environmental Policy Act (NEPA), for applicant projects or proposals which are seeking NOAA federal funding opportunities. Detailed information on NOAA compliance with NEPA can be found at the following NOAA NEPA website:
Consequently, as part of an applicant's package, and under their description of their program activities, applicants are required to provide detailed information on the activities to be conducted, locations, sites, species and habitat to be affected, possible construction activities, and any environmental concerns that may exist (e.g., the use and disposal of hazardous or toxic chemicals, introduction of non-indigenous species, impacts to endangered and threatened species, aquaculture projects, and impacts to coral reef systems). In addition to providing specific information that will serve as the basis for any required impact analyses, applicants may also be requested to assist NOAA in drafting of an environmental assessment, if NOAA determines an assessment is required. Applicants will also be required to cooperate with NOAA in identifying and implementing feasible measures to
The Department of Commerce Pre-Award Notification Requirements for Grants and Cooperative Agreements. The Department of Commerce Pre-Award Notification Requirements for Grants and Cooperative Agreements contained in the
This document contains collection-of-information requirements subject to the Paperwork Reduction Act (PRA). The use of Standard Forms 424 and 424A,424B, SF-LLL, and CD-346 has been approved by the Office of Management and Budget (OMB) under the respective control numbers 0348-0043, 0348-0044, 0348-0040, 0348-0046, and 0605-0001. Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA unless that collection of information displays a currently valid OMB control number.
This notice has been determined to be not significant for purposes of Executive Order 12866.
It has been determined that this notice does not contain policies with Federalism implications as that term is defined in Executive Order 13132. Administrative Procedure Act/ Regulatory Flexibility Act Prior notice and an opportunity for public comment are not required by the Administrative Procedure Act or any other law for rules concerning public property, loans, grants, benefits, and contracts (5 U.S.C. 553(a)(2)). Because notice and opportunity for comment are not required pursuant to 5 U.S.C. 553 or any other law, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601
The Commodity Futures Trading Commission has determined to renew the charter of its Global Markets Advisory Committee. As required by Sections 9(a)(2) and 14(a)(2)(A) of the Federal Advisory Committee Act, 5 U.S.C. app. 2, §§ 9(a)(2) and 14(a)(2)(A), and 41 CFR 101-6.1007 and 101-6.129, the Commission has consulted with the Committee Management Secretariat of the General Services Administration. The Commission certifies that the renewal of this advisory committee is necessary and is in the public interest in connection with the performance of duties imposed on the Commission by the Commodity Exchange Act, 7 U.S.C. 1,
Martin B. White, Committee Management Officer, at 202-418-5129. Written comments should be submitted to Jean A. Webb, Secretary, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street, NW., Washington, DC 20581.
The purpose of the Global Markets Advisory Committee is to provide the Commission with input on international market issues that affect the integrity and competitiveness of U.S. futures markets. The advisory committee also serves as a channel for communication between the Commission and U.S. and foreign markets, firms and end users involved in and affected by market globalization.
Contemporaneously with publication of this notice in the
Department of Defense.
Notice of Advisory Committee Meetings.
The Defense Science Board Task Force on Critical Homeland Installation Protection will meet in closed sessions on October 4-5, 2004; and October 28-29, 2004, at SAIC, 4001 N. Fairfax Drive, Suite 500, Arlington, VA. The Task Force will assess best practices for protecting U.S. homeland installations and recommend various approaches to enhancing security and protection of these facilities.
The mission of the Defense Science Board is to advise the Secretary of Defense and the Under Secretary of Defense for Acquisition, Technology & Logistics on scientific and technical matters as they affect the perceived needs of the Department of Defense. At these meetings, the Task Force will assess investments in technology and manpower in order to ensure proper security levels at our nation's high-value installations with particular emphasis on airports, harbors, nuclear power facilities and military bases. To that end, the Task Force will review existing best practices in force protection and security at civil, industrial and military complexes; assess shortfalls and deficiencies associated with operational security; identify promising technology and/or processes that will enhance security; and recommend methods for reducing overall manpower requirements without relinquishing robust security measures.
In accordance with Section 10(d) of the Federal Advisory Committee Act, Pub. L. 92-463, as amended (5 U.S.C. App. II), it has been determined that these Defense Science Board Task Force meetings concern matters listed in 5 U.S.C. 552b(c)(1) and that, accordingly, the meetings will be closed to the public.
Department of Education.
The Leader, Regulatory Information Management Group, Office of the Chief Information Officer invites comments on the submission for OMB review as required by the Paperwork Reduction Act of 1995.
Interested persons are invited to submit comments on or before August 13, 2004.
Written comments should be addressed to the Office of Information and Regulatory Affairs, Attention: Carolyn Lovett, Desk Officer, Department of Education, Office of Management and Budget, 725 17th Street, NW., Room 10235, New Executive Office Building, Washington, DC 20503 or faxed to (202) 395-6974.
Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that the Office of Management and Budget (OMB) provide interested Federal agencies and the public an early opportunity to comment on information collection requests. OMB may amend or waive the requirement for public consultation to the extent that public participation in the approval process would defeat the purpose of the information collection, violate State or Federal law, or substantially interfere with any agency's ability to perform its statutory obligations. The Leader, Regulatory Information Management Group, Office of the Chief Information Officer, publishes that notice containing proposed information collection requests prior to submission of these requests to OMB. Each proposed information collection, grouped by office, contains the following: (1) Type of review requested,
Responses: 906,322.
Burden Hours: 231,800.
Requests for copies of the submission for OMB review; comment request may be accessed from
Comments regarding burden and/or the collection activity requirements should be directed to Kathy Axt at her e-mail address
White House Initiative on Tribal Colleges and Universities (WHITCU), U.S. Department of Education.
Notice of meeting.
This notice sets forth the schedule and proposed agenda of an upcoming meeting of the President's Board of Advisors on Tribal Colleges and Universities (the Board) and is intended to notify the general public of their opportunity to attend. This notice also describes the functions of the Board. Notice of the Board's meetings is required under section 10(a)(2) of the Federal Advisory Committee Act and by the Board's charter.
The purpose of the meeting will be to discuss the Board's Report to the President; the strategic plan of the Board; and the Federal agency reports submitted for calendar year 2003.
July 20, 2004—9 a.m. to 5:30 p.m. July 21, 2004—9 a.m. to 2:30 p.m.
Coeur D'Alene Resort Hotel, U.S. Highway 95, Worley, Idaho.
Diane L. Cullo, Executive Director, White House Initiative on Tribal Colleges and Universities, U.S. Department of Education, 400 Maryland Avenue, SW., Room 3W207, Washington, DC 20202. Telephone: 202-260-1571, Fax: 202-260-4149.
The Board is established by Executive Order 13270, dated July 3, 2002, and Executive Order 13316 of September 17, 2003, to provide advice regarding the progress made by Federal agencies toward fulfilling the purposes and objectives of Executive Order 13316. The Board also provides recommendations to the President through the Secretary of Education on ways the Federal government can help tribal colleges: (1) Use long-term development, endowment building and planning to strengthen institutional viability; (2) improve financial management and security, obtain private sector funding support, and expand and complement Federal education initiatives; (3) develop institutional capacity through the use of new and emerging technologies offered by both the Federal and private sectors; (4) enhance physical infrastructure to facilitate more efficient operation and effective recruitment and retention of students and faculty; and (5) help implement the
The general public is welcome to attend the July 20-21, 2004 meeting. However, space is limited and is available on a first-come, first-served basis. Individuals who need accommodations for a disability in order to attend the meeting (
A summary of the activities of the meeting and other related materials that are informative to the public will be available to the public within 14 days after the meeting. Records are kept of all Board proceedings and are available for public inspection at the White House Initiative on Tribal Colleges and Universities, U.S. Department of Education, 400 Maryland Avenue, SW., Room 3W207, Washington, DC 20202.
Take notice that on July 1, 2004, Algonquin Gas Transmission Company (Algonquin) and Algonquin Gas Transmission, LLC (Algonquin LLC) tendered for filing its FERC Gas Tariff, Fifth Revised Volume No. 1 and First Revised Volume No. 2 to reflect a corporate name change effective July 1, 2004. Algonquin states that this effective date coincides with the date Algonquin converts from a corporation to a limited liability company.
Algonquin and Algonquin LLC state that copies of the transmittal letter, the Appendix A list of tariff sheets, and Appendices B through D have been served upon all affected customers and interested State commissions.
Any person desiring to be heard or to protest said filing should file a motion to intervene or a protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Sections 385.214 or 385.211 of the Commission's Rules and Regulations. All such motions or protests must be filed in accordance with Section 154.210 of the Commission's Regulations. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceedings. Any person wishing to become a party must file a motion to intervene. This filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
Take notice that on June 30, 2004, ANR Pipeline Company (ANR), tendered for filing as part of its FERC Gas Tariff, Second Revised Volume No. 1, the tariff sheets listed on Appendix A to the filing, with an effective date of August 1, 2004.
ANR states that it is tendering the referenced tariff sheets to delete all references to the mandatory Gas Research Institute surcharges, while retaining the existing provisions relating to the remittance to GRI of voluntary amounts contributed by customers.
Any person desiring to be heard or to protest said filing should file a motion to intervene or a protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Sections 385.214 or 385.211 of the Commission's Rules and Regulations. All such motions or protests must be filed in accordance with Section 154.210 of the Commission's Regulations. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceedings. Any person wishing to become a party must file a motion to intervene. This filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
Take notice that on July 1, 2004, Colorado Interstate Gas Company (CIG) tendered for filing as part of its FERC Gas Tariff, First Revised Volume No. 1, the tariff sheets listed in Appendix A to the filing, with an effective date of August 1, 2004.
CIG states that these tariff sheets are filed to discontinue the collection of the mandatory GRI surcharges effective August 1, 2004.
Any person desiring to be heard or to protest said filing should file a motion to intervene or a protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Sections 385.214 or 385.211 of the Commission's Rules and Regulations. All such motions or protests must be filed in accordance with Section 154.210 of the Commission's Regulations. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceedings. Any person wishing to become a party must file a motion to intervene. This filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
Take notice that on July 1, 2004, Columbia Gas Transmission Corporation (Columbia) tendered for filing as part of its FERC Gas Tariff, Second Revised Volume No. 1, the following revised tariff sheets with a proposed effective date of August 1, 2004:
Columbia states it is submitting the above-referenced revised tariff sheets for the purpose of eliminating the Research, Development and Demonstration (RD&D) funding surcharge currently reflected in Columbia's rates and collected on behalf of the Gas Research Institute (GRI).
Columbia states that copies of its revised tariff sheets have been mailed to all firm customers, interruptible customers, and affected state commissions.
Any person desiring to be heard or to protest said filing should file a motion to intervene or a protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Sections 385.214 or 385.211 of the Commission's Rules and Regulations. All such motions or protests must be filed in accordance with Section 154.210 of the Commission's Regulations. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceedings. Any person wishing to become a party must file a motion to intervene. This filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
Take notice that on July 1, 2004, Columbia Gulf Transmission Company (Columbia Gulf) tendered for filing as part of its FERC Gas Tariff, Second Revised Volume No. 1, the following revised tariff sheets with a proposed effective date of August 1, 2004:
Columbia Gulf states it is submitting the above-referenced revised tariff sheets for the purpose of eliminating the Research, Development and Demonstration (RD&D) funding surcharge currently reflected in Columbia Gulf's rates and collected on behalf of the Gas Research Institute (GRI). Columbia Gulf further states that the elimination of the RD&D funding surcharge is being proposed in accordance with the terms of the 1998 Settlement Agreement entered into by GRI and numerous parties.
Columbia Gulf states that copies of its filing have been mailed to all firm customers, interruptible customers, and affected state commissions.
Any person desiring to be heard or to protest said filing should file a motion to intervene or a protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Sections 385.214 or 385.211 of the Commission's Rules and Regulations. All such motions or protests must be filed in accordance with Section 154.210 of the Commission's Regulations. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceedings. Any person wishing to become a party must file a motion to intervene. This filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
On June 21, 2004, Dominion Transmission, Inc. (Dominion), 120 Tredegar Street, Richmond, Virginia 23219, filed an application in the above referenced docket, pursuant to section 7(c) of the Natural Gas Act (NGA), and part 157 of the Federal Energy Regulatory Commission's (Commission) Rules and Regulations to construct, install, own, operate, and maintain certain facilities, located in West Virginia, Pennsylvania, and New York. Dominion's Northeast Storage Project will provide 9.4 Bcf of firm natural gas storage service and 163,017 dekatherms per day of winter-season firm transportation service. This filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
Any questions regarding this application should be directed to Anne E. Bomar, Managing Director, Transmission Rates and Regulation, Dominion Transmission, Inc., 120 Tredegar Street, Richmond, Virginia 23219, telephone (804) 819-2134.
There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, on or before the comment date stated below file with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by all other parties. A party must submit 14 copies of filings made in the proceeding with the Commission and must mail a copy to the applicant and to every other party. Only parties to the proceeding can ask for court review of Commission orders in the proceeding.
However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest.
Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commenters will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commenters will not be required to serve copies of filed documents on all other parties. However, the non-party commenters will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.
Protests and interventions may be filed electronically via the Internet in lieu of paper; see, 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site under the “e-Filing” link. The Commission strongly encourages electronic filings.
Take notice that on June 30, 2004, Dominion Transmission, Inc. (DTI) tendered for filing as part of its FERC Gas Tariff, Third Revised Volume No. 1, the following tariff sheets, to become effective August 1, 2004:
DTI states that the purpose of this filing is to reflect the elimination of the GRI surcharge.
Any person desiring to be heard or to protest said filing should file a motion to intervene or a protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Sections 385.214 or 385.211 of the Commission's Rules and Regulations. All such motions or protests must be filed in accordance with Section 154.210 of the Commission's Regulations. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceedings. Any person wishing to become a party must file a motion to intervene. This filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
Take notice that on July 1, 2004, East Tennessee Natural Gas Company (East Tennessee) and East Tennessee Natural Gas, LLC (East Tennessee LLC) tendered for filing as part of its FERC Gas Tariff, Third Revised Volume No. 1, to reflect a corporate name change to become effective July 1, 2004. East Tennessee and East Tennessee LLC state this effective date coincides with the date East Tennessee converts from a corporation to a limited liability company.
East Tennessee and East Tennessee LLC state that copies of the transmittal letter, the Appendix A list of tariff sheets, and Appendices B through D have been served upon all affected customers and interested State commissions, and that copies of the revised tariff sheets in Appendix A will be provided, upon request, via overnight mail.
Any person desiring to be heard or to protest said filing should file a motion to intervene or a protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Sections 385.214 or 385.211 of the Commission's Rules and Regulations. All such motions or protests must be filed in accordance with Section 154.210 of the Commission's Regulations. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceedings. Any person wishing to become a party must file a motion to intervene. This
Take notice that on July 8, 2004, El Paso Natural Gas Company (El Paso) tendered for filing as part of its FERC Gas Tariff, Second Revised Volume No. 1-A, the tariff sheets listed in Appendix A to the filing, with an effective date of August 1, 2004.
El Paso states that these tariff sheets are filed to discontinue the collection of the mandatory GRI surcharges effective August 1, 2004.
Any person desiring to be heard or to protest said filing should file a motion to intervene or a protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Sections 385.214 or 385.211 of the Commission's Rules and Regulations. All such motions or protests must be filed in accordance with Section 154.210 of the Commission's Regulations. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceedings. Any person wishing to become a party must file a motion to intervene. This filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
Take notice that on June 30, 2004, Florida Gas Transmission Company (FGT) tendered for filing to become part of its FERC Gas Tariff, Third Revised Volume No. 1, the following tariff sheets, with an effective date of August 1, 2004:
FGT states that it is filing the referenced tariff sheets pursuant to the Gas Research Institute's (GRI) Settlement Agreement dated March 10, 1998, approved by the Commission's Order issued April 29, 1998, in Docket No. RP97-149-003; and the 2002-2006 Five-Year Plan as approved by the Commission Order issued September 19, 2001, in Docket No. RP01-434. FGT also states that it received a letter dated May 25, 2004, from GRI advising FGT to discontinue collecting the GRI surcharges effective August 1, 2004. In the instant tariff sheets, FGT states that it has reduced the current GRI demand and commodity surcharges to $0.0000 to be effective August 1, 2004.
Any person desiring to be heard or to protest said filing should file a motion to intervene or a protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Sections 385.214 or 385.211 of the Commission's Rules and Regulations. All such motions or protests must be filed in accordance with Section 154.210 of the Commission's Regulations. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceedings. Any person wishing to become a party must file a motion to intervene. This filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
Take notice that on July 1, 2004, the Gas Technology Institute (GTI) filed an application requesting approval of a 2005-2009 Five-Year Collaborative Research, Development and Demonstration (RD&D) Plan, a 2005 GTI RD&D Program, and advance rate approval for collection of the funding of its RD&D activities for 2005, pursuant to section 154.401 of the Commission's Regulations. GTI states in its application that numerous jurisdictional natural gas companies (
Any person desiring to be heard or to protest said filing should file a motion to intervene or a protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Sections 385.214 or 385.211 of the Commission's Rules and Regulations. All such motions or protests must be filed in accordance with Section 154.210 of the Commission's Regulations. Protests will be considered by the Commission in determining the appropriate action to be
Take notice that on July 1, 2004, Granite State Gas Transmission, Inc. (Granite State) tendered for filing as part of its FERC Gas Tariff, Third Revised Volume No. 1, the following revised tariff sheets with a proposed effective date of August 1, 2004:
Granite State states it is submitting the above-referenced revised tariff sheets for the purpose of eliminating the Research, Development and Demonstration (RD&D) funding surcharge currently reflected in Granite State's rates and collected on behalf of the Gas Research Institute (GRI).
Granite State states that copies of its filing have been mailed to all firm customers, interruptible customers, and affected state commissions.
Any person desiring to be heard or to protest said filing should file a motion to intervene or a protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Sections 385.214 or 385.211 of the Commission's Rules and Regulations. All such motions or protests must be filed in accordance with Section 154.210 of the Commission's Regulations. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceedings. Any person wishing to become a party must file a motion to intervene. This filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
Take notice that on July 1, 2004, Iroquois Gas Transmission System, L.P. (Iroquois) tendered for filing the following revised sheet to its FERC Gas Tariff, First Revised Volume No. 1, to be effective on August 1, 2004:
Iroquois states that the purpose of Iroquois' instant filing provides for the elimination of the Gas Research Institute (GRI) surcharge (set forth in section 12.1 of the General Terms and Conditions) from the tariff.
Any person desiring to be heard or to protest said filing should file a motion to intervene or a protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with sections 385.214 or 385.211 of the Commission's Rules and Regulations. All such motions or protests must be filed in accordance with section 154.210 of the Commission's Regulations. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceedings. Any person wishing to become a party must file a motion to intervene. This filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
Take notice that on June 30, 2004, Maritimes & Northeast Pipeline, L.L.C. (Maritimes) tendered for filing as part of its FERC Gas Tariff, First Revised Volume No. 1, the tariff sheets listed in Appendix C to the filing, with effective dates of August 1, 2004.
Maritimes states that its rate case filing is being made in compliance with Article III of the uncontested Stipulation and Agreement in Docket No. RP02-134, et al., which requires Maritimes to file a rate case under section 4 of the NGA no later than April 1, 2006. Maritimes states that the purpose of this filing is to increase its mainline and incremental lateral line transportation rates.
Maritimes states that copies of its filing have been mailed to all affected customers and interested State commissions.
Any person desiring to be heard or to protest said filing should file a motion to intervene or a protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Sections 385.214 or 385.211 of the Commission's Rules and Regulations. All such motions or protests must be filed in accordance with Section 154.210 of the Commission's Regulations. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceedings. Any person wishing to become a party must file a motion to intervene. This filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
Take notice that on July 1, 2004 MIGC, Inc. (MIGC), tendered for filing as part of its FERC Gas Tariff, First Revised Volume No. 1, Eighth Revised Sheet No. 6, with a proposed effective date of August 1, 2004.
MIGC states that the purpose of the filing is to revise and update the fuel retention and loss percentage factors (FL&U factors) set forth in its FERC Gas Tariff, First Revised Volume No. 1 in accordance with the requirements of section 25 of said tariff.
MIGC states that copies of its filing are being mailed to its jurisdictional customers and interested State commissions.
Any person desiring to be heard or to protest said filing should file a motion to intervene or a protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with sections 385.214 or 385.211 of the Commission's Rules and Regulations. All such motions or protests must be filed in accordance with section 154.210 of the Commission's Regulations. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceedings. Any person wishing to become a party must file a motion to intervene. This filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
Take notice that on July 1, 2004, Mojave Pipeline Company (Mojave) tendered for filing to its FERC Gas Tariff, Second Revised Volume No. 1, the following tariff sheets, with an effective date of August 1, 2004:
Mojave states that these tariff sheets are filed to discontinue the collection of the mandatory GRI surcharges effective August 1, 2004.
Any person desiring to be heard or to protest said filing should file a motion to intervene or a protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with sections 385.214 or 385.211 of the Commission's Rules and Regulations. All such motions or protests must be filed in accordance with section 154.210 of the Commission's Regulations. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceedings. Any person wishing to become a party must file a motion to intervene. This filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
Take notice that on July 1, 2004, National Fuel Gas Supply Corporation (National Fuel) tendered for filing as part of its FERC Gas Tariff, Fourth Revised Volume No. 1, the tariff sheets listed on Appendix A to its filing, to be effective August 1, 2004.
National Fuel states that the purpose of this filing is to discontinue and to remove from its tariff the Gas Research Institute (GRI) RD&D funding surcharge, in accordance with the 1998 Settlement Agreement approved by the Commission in Docket No. RP97-149-003,
National Fuel states that copies of this filing were served upon its customers and interested state commissions.
Any person desiring to be heard or to protest said filing should file a motion
Take notice that on June 30, 2004, Northwest Pipeline Corporation (Northwest) tendered for filing as part of its FERC Gas Tariff, Third Revised Volume No. 1, Fifth Revised Sheet No. 373, to be effective August 1, 2004. Northwest also tendered for filing a Rate Schedule TF-1 non-conforming service agreement.
Northwest states that the purpose of this filing is to: (1) Submit a Rate Schedule TF-1 service agreement containing contract-specific operational flow order provisions that do not conform to the Rate Schedule TF-1 form of service agreement contained in Northwest's tariff, (2) add this agreement to the list of non-conforming service agreements in Northwest's tariff, and (3) remove a service agreement due to termination from the list of non-conforming service agreements in Northwest's tariff.
Northwest states that a copy of this filing has been served upon Northwest's customers and interested state regulatory commissions.
Any person desiring to be heard or to protest said filing should file a motion to intervene or a protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with sections 385.214 or 385.211 of the Commission's Rules and Regulations. All such motions or protests must be filed in accordance with section 154.210 of the Commission's Regulations. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceedings. Any person wishing to become a party must file a motion to intervene. This filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
On June 25, 2004, Northwest Pipeline Corporation (Northwest) filed a petition for temporary limited tariff waiver, seeking an extension of time to defer Northwest's tariff provisions to implement the revised Forms of Transportation Service Agreements that were accepted in the Commission's Order issued July 1, 2004, in the above-docketed proceeding. The petition states that Northwest cannot implement the revised Forms of Transportation Service Agreements until corresponding programming modifications are made to its Northwest Passage system. The petition also states that Northwest will continue to use the previously effective Forms of Transportation Service Agreements for transactions on Northwest Passage.
Upon consideration, notice is hereby given that an extension of time for implementation of the revised Forms of Transportation Service Agreements for Rate Schedules TF-1, TF-2, and TI-1 is granted to and including October 1, 2004, as requested by Northwest.
On December 16, 2003, Pacific Gas and Electric Company filed an application for a new license for the continued operation and maintenance of the 143-megawatt Poe Project No. 2107, located on the North Fork Feather River in Butte County, near Pulga, California. The Commission issued public notice of the application on March 24, 2004, setting May 24, 2004, as the deadline for filing motions to intervene.
On June 14, 2004, Butte County, California, filed a late motion to intervene. Granting the late motion to intervene will not unduly delay or disrupt the proceeding or prejudice other parties to it. Therefore, pursuant to Rule 214,
Take notice that the following application has been filed with the Commission and is available for public inspection:
a.
b.
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d.
e.
f.
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h.
i.
j. Deadline for filing comments and or motions: August 9, 2004.
All documents (original and eight copies) should be filed with: Ms. Magalie R. Salas, Secretary, Federal Energy Regulatory Commission, 888 First Street, NE., Washington DC 20426. Please include the project number (P-516-393) on any comments or motions filed. Comments, protests, and interventions may be filed electronically via the internet in lieu of paper. See, 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site under the “e-Filing” link. The Commission strongly encourages e-filings.
k. Description of Proposal: South Carolina Electric & Gas Company requests Commission authorization to permit Salvatore Livreri to dredge an estimated 2,000 cubic yards of material from an area below the 360-foot contour to accommodate boat access to Lake Murray. The dredged material would be trucked to a county landfill. The proposed dredging would be performed within a cove fronting Mr. Livreri's two residential lots at 333 and 351 Wells Point Road in the Town of Prosperity, Newberry County, South Carolina.
l. Location of the Applications: The filings are available for review at the Commission in the Public Reference Room, located at 888 First Street, NE., Room 2A, Washington, DC 20426, or may be viewed on the Commission's Web site at
m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
n. Comments, Protests, or Motions to Intervene—Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.
o. Filing and Service of Responsive Documents—Any filings must bear in all capital letters the title “COMMENTS”, “RECOMMENDATIONS FOR TERMS AND CONDITIONS”, “PROTEST”, OR “MOTION TO INTERVENE”, as applicable, and the Project Number of the particular application to which the filing refers. A copy of any motion to intervene must also be served upon each representative of the Applicant specified in the particular application.
p. Agency Comments—Federal, state, and local agencies are invited to file comments on the described applications. A copy of the applications may be obtained by agencies directly from the Applicant. If an agency does not file comments within the time specified for filing comments, it will be presumed to have no comments. One copy of an agency's comments must also be sent to the Applicant's representatives.
q. Comments, protests and interventions may be filed electronically via the Internet in lieu of paper. See, 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site at
Take notice that on June 30, 2004, Southern Natural Gas Company (Southern) tendered for filing as part of its FERC Gas Tariff, Seventh Revised Volume No. 1, the following revised sheets to become effective August 1, 2004:
Southern states that the proposed tariff sheets reflect the discontinuation of the GRI Surcharge pursuant to the Gas Research Institute (GRI) Settlement August 1, 2004. In addition, Southern further states that they propose to continue to collect voluntary R&D contributions after the discontinuance of the GRI Surcharge.
Any person desiring to be heard or to protest said filing should file a motion to intervene or a protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Sections 385.214 or 385.211 of the Commission's Rules and Regulations. All such motions or protests must be filed in accordance with Section 154.210 of the Commission's Regulations. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceedings. Any person wishing to become a party must file a motion to intervene. This filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
Take notice that on June 29, 2004, Tennessee Gas Pipeline Company (Tennessee), tendered for filing as part of its FERC Gas Tariff, Fifth Revised Volume No. 1, Fourth Revised Sheet No. 306, with an effective date of August 1, 2004.
Tennessee states that the purpose of this filing is to revise Article II, Section 2 of the General Terms & Conditions (GT&C) of its Tariff to provide production meter operators on Tennessee's system with the right to agree to indemnity provisions if the production meter operators desire, for their own business requirements, to receive gas that does not conform with one or more parts of the gas quality specifications of Article II, Section 1 of the GT&C of Tennessee's Tariff.
Any person desiring to be heard or to protest said filing should file a motion to intervene or a protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Sections 385.214 or 385.211 of the Commission's Rules and Regulations. All such motions or protests must be filed in accordance with Section 154.210 of the Commission's Regulations. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceedings. Any person wishing to become a party must file a motion to intervene. This filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
Take notice that on June 30, 2004 Tennessee Gas Pipeline Company (Tennessee) tendered for filing as part of its FERC Gas Tariff, Fifth Revised Volume No. 1 and Original Volume No. 2, the tariff sheets listed on Appendix A to the filing, with an effective date of August 1, 2004.
Tennessee states that it is tendering the referenced tariff sheets to delete all references to the mandatory Gas Research Institute (GRI) surcharges, while retaining the existing provisions relating to the remittance to GRI of voluntary amounts contributed by customers.
Any person desiring to be heard or to protest said filing should file a motion to intervene or a protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Sections 385.214 or 385.211 of the Commission's Rules and Regulations. All such motions or protests must be filed in accordance with Section 154.210 of the Commission's Regulations. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceedings. Any person wishing to become a party must file a motion to intervene. This filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
Take notice that on June 30, 2004, Texas Eastern Transmission, LP (Texas Eastern) tendered for filing as part of its FERC Gas Tariff, Seventh Revised Volume No. 1 and First Revised Volume No. 2, the revised tariff sheets listed on Appendix A to the filing, to become effective August 1, 2004.
Texas Eastern states that the purpose of this filing is to reduce the Gas Research Institute (GRI) surcharges to zero effective August 1, 2004 in compliance with the January 21, 1998, Stipulation and Agreement Concerning GRI Funding (Settlement) approved by the Commission in
Texas Eastern states that copies of the filing have been served upon all affected customers of Texas Eastern and interested state commissions.
Any person desiring to be heard or to protest said filing should file a motion to intervene or a protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Sections 385.214 or 385.211 of the Commission's Rules and Regulations. All such motions or protests must be filed in accordance with Section 154.210 of the Commission's Regulations. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceedings. Any person wishing to become a party must file a motion to intervene. This filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
Take notice that on June 30, 2004, Texas Eastern Transmission, LP (Texas Eastern) tendered for filing as part of its FERC Gas Tariff, Seventh Revised Volume No. 1, and First Revised Volume No. 2, revised tariff sheets listed on Appendix B to the filing to become effective August 1, 2004.
Texas Eastern states that these revised tariff sheets are filed pursuant to Section 15.1, Electric Power Cost (EPC) Adjustment, of the General Terms and Conditions of Texas Eastern's FERC Gas Tariff, Seventh Revised Volume No. 1. Texas Eastern states that Section 15.1 provides that Texas Eastern shall file, to be effective each August 1, revised rates for each applicable zone and rate schedule based upon the projected annual electric power costs required for the operation of transmission compressor stations with electric motor prime movers. Texas Eastern states that all costs of electric power compression required for the incremental services under the TIME and Freehold Projects are appropriately assigned to the incremental projects as required by the Commission orders certificating the TIME and Freehold Projects.
Texas Eastern states that the proposed rate changes to the primary firm capacity reservation charges, usage rates and 100% load factor average costs reflected on the revised tariff sheets, for example, for full Access Area Boundary service from the Access Area Zone, East Louisiana, to the three market area zones are as follows:
Texas Eastern states that copies of its filing have been served upon all affected customers of Texas Eastern and interested State commissions.
Any person desiring to be heard or to protest said filing should file a motion to intervene or a protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Sections 385.214 or 385.211 of the Commission's Rules and Regulations. All such motions or protests must be filed in accordance with Section 154.210 of the Commission's Regulations. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceedings. Any person wishing to become a party must file a motion to intervene. This filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
Take notice that on June 30, 2004, Texas Gas Transmission, LLC (Texas Gas) tendered for filing as part of its FERC Gas Tariff, Second Revised Volume No. 1, the tariff sheets listed on Appendix A to the filing, to become effective August 1, 2004.
Texas Gas states that the purpose of this filing is to act in accordance with the terms and conditions of the Order Approving Settlement (the Order) issued on April 29, 1998 (Docket No. RP97-149-003,
Texas Gas states that it has been notified by letter from the GRI that it projects that the actual collections under the funding surcharges approved by the Commission will reach the approved amounts provided for in the Order by August 1, 2004; therefore, Texas Gas herein seeks to remove the GRI surcharge from its rates, effective on that date, and to amend its tariff by deleting specific references to the GRI surcharge from its General Terms and Conditions (GT&C).
Texas Gas states that copies of this filing are being mailed to all parties on Texas Gas's official list, to Texas Gas's jurisdictional customers, and to interested state commissions.
Any person desiring to be heard or to protest said filing should file a motion to intervene or a protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Sections 385.214 or 385.211 of the Commission's Rules and Regulations. All such motions or protests must be filed in accordance with Section 154.210 of the Commission's Regulations. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceedings.
Take notice that on June 30, 2004, Transwestern Pipeline Company (Transwestern) tendered for filing as part of its FERC Gas Tariff, Second Revised Volume No. 1, the following tariff sheets to become effective August 1, 2004:
Transwestern states that it is filing the referenced tariff sheets pursuant to the Gas Research Institute's (GRI) Settlement Agreement dated March 10, 1998, approved by the Commission's Order issued April 29, 1998, in Docket No. RP97-149-003 and the 2002-2006 Five-Year Plan as approved by the Commission Order issued September 19, 2001, in Docket No. RP01-434. Transwestern also states that it received a letter dated May 25, 2004, from GRI advising Transwestern to discontinue collecting the GRI surcharges effective August 1, 2004.
Any person desiring to be heard or to protest said filing should file a motion to intervene or a protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Sections 385.214 or 385.211 of the Commission's Rules and Regulations. All such motions or protests must be filed in accordance with Section 154.210 of the Commission's Regulations. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceedings. Any person wishing to become a party must file a motion to intervene. This filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
Take notice that on July 1, 2004, Trunkline Gas Company, LLC (Trunkline) tendered for filing as part of its FERC Gas Tariff, Third Revised Volume No. 1, the revised tariff sheets listed in Appendix A attached to the filing to become effective August 1, 2004.
Trunkline states that this filing is being made to discontinue the Gas Research Institute (GRI) surcharges effective August 1, 2004, in compliance with the January 21, 1998, Stipulation and Agreement Concerning GRI Funding (Settlement Agreement) approved by the Commission in
Trunkline further states that copies of this filing are being served on all affected customers and applicable state regulatory agencies.
Any person desiring to be heard or to protest said filing should file a motion to intervene or a protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Sections 385.214 or 385.211 of the Commission's Rules and Regulations. All such motions or protests must be filed in accordance with Section 154.210 of the Commission's Regulations. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceedings. Any person wishing to become a party must file a motion to intervene. This filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
Take notice that on July 1, 2004, Viking Gas Transmission Company (Viking) tendered for filing to be part of its FERC Gas Tariff, First Revised Volume No. 1, the following tariff sheets proposed to become effective August 1, 2004:
Viking states that the purpose of this filing is to amend section 17 of the General Terms and Conditions of Viking's FERC Gas Tariff to add a provision which identifies the types of discounts that Viking may enter into with customers on its systems without creating a material deviation from Viking's
Any person desiring to be heard or to protest said filing should file a motion to intervene or a protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Sections 385.214 or 385.211 of the Commission's Rules and Regulations. All such motions or protests must be filed in accordance with Section 154.210 of the Commission's Regulations. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceedings. Any person wishing to become a party must file a motion to intervene. This filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
Take notice that on July 1, 2004, Viking Gas Transmission Company (Viking) tendered for filing to be part of Viking's FERC Gas Tariff, First Revised Volume No. 1, the following tariff sheets proposed to become effective August 1, 2004:
Viking is proposing to add Article IV to the form of Operational Balancing Agreement for use at delivery points (OBA) which will set forth the Daily Demand Quantity elected by the Balancing Party for use under, and as set forth in, Rate Schedule LMS.
Any person desiring to be heard or to protest said filing should file a motion to intervene or a protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Sections 385.214 or 385.211 of the Commission's Rules and Regulations. All such motions or protests must be filed in accordance with Section 154.210 of the Commission's Regulations. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceedings. Any person wishing to become a party must file a motion to intervene. This filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
Take notice that on July 1, 2004, Williston Basin Interstate Pipeline Company (Williston Basin) tendered for filing as part of its FERC Gas Tariff, Second Revised Volume No. 1, Eighth Revised Sheet No. 376, to become effective July 1, 2004.
Williston Basin states that it has revised the above-referenced tariff sheet found in Section 48 of the General Terms and Conditions of its Tariff to add a receipt point, Point ID No. 05061 (Middle Prong), to Williston Basin's Powder River Pool.
Any person desiring to be heard or to protest said filing should file a motion to intervene or a protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Sections 385.214 or 385.211 of the Commission's Rules and Regulations. All such motions or protests must be filed in accordance with Section 154.210 of the Commission's Regulations. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceedings. Any person wishing to become a party must file a motion to intervene. This filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
Take notice that on July 1, 2004, Williston Basin Interstate Pipeline Company (Williston Basin), tendered for filing to become a part of its FERC Gas Tariff, Second Revised Volume No. 1 and Original Volume No. 1, the tariff sheets listed on Appendix A to the filing, with an effective date of August 1, 2004.
Williston Basin states that, pursuant to a May 25, 2004 letter from the Gas Research Institute, the proposed tariff changes are being filed to remove all references to the Gas Technology Institute and the Gas Research Institute from the Rate Sheets, Rate Schedules and General Terms and Conditions of its Tariff effective August 1, 2004.
Any person desiring to be heard or to protest said filing should file a motion to intervene or a protest with the Federal Energy Regulatory Commission, 888 First Street, N.E., Washington, DC 20426, in accordance with Sections 385.214 or 385.211 of the Commission's Rules and Regulations. All such motions
Take notice that on July 1, 2004, Wyoming Interstate Company, Ltd. (WIC) tendered for filing as part of its FERC Gas Tariff, Second Revised Volume No. 2, the following tariff sheets, with an effective date of August 1, 2004:
WIC states that these tariff sheets are filed to discontinue the collection of the mandatory GRI surcharges effective August 1, 2004.
Any person desiring to be heard or to protest said filing should file a motion to intervene or a protest with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Sections 385.214 or 385.211 of the Commission's Rules and Regulations. All such motions or protests must be filed in accordance with Section 154.210 of the Commission's Regulations. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceedings. Any person wishing to become a party must file a motion to intervene. This filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
On March 12, 2004, the Commission requested applications to be included on a list of resource experts willing to serve as a third panel member in the study dispute resolution process of the Commission's hydropower integrated licensing process (ILP). We are reopening the application period until September 30, 2004, to afford interested parties more time to respond to the original request. Respondents to the initial request need not reapply to be considered.
The Commission's ILP encourages informal resolution of study disagreements. In cases where this is not successful, a formal study dispute resolution process is available for State and Federal agencies or Indian tribes with mandatory conditioning authority.
The ILP provides that the disputed study must be submitted to a dispute resolution panel consisting of a person from Commission staff, a person from the agency or Indian tribe referring the dispute to the Commission, and a third person selected by the other two panelists from a pre-established list of persons with expertise in the disputed resource area.
The role of the panel members is to make a finding, with respect to each disputed study request, on the extent to which each study criteria set forth in the regulations is or is not met,
TPMs can only be selected from a list of qualified persons (TPM List) that is developed and maintained by the Commission. Each qualified panel member will be listed by area(s) and sub-area(s) of technical expertise, for example Fisheries Resources-instream flow. The Commission is seeking the service of individuals with technical expertise in specific resource areas. While such individuals should be able to promote constructive dialog among the panelists, the Commission is not seeking the services of a mediator or arbitrator.
The TPM list will be available to the public on the Commission's web site. All individuals submitting their applications to the Commission for consideration must meet the Commission's qualifications.
The applicant should describe in detail his/her qualifications in items 1-4 listed below. To expedite processing of the application and to ensure accurate identification of areas of interest and expertise, the applicant must, in response to item 1, list the specific resource area(s) for which he/she wishes to be considered, such as “Aquatic Resources: water quality and instream flow” or “Recreational Resources: whitewater boating and general”.
1. Technical expertise, including education and experience in each resource area and sub-area for which the applicant wishes to be considered:
2. Knowledge of the effects of construction and operation of hydroelectric projects.
3. Working knowledge of laws relevant to expertise, such as: The Fish and Wildlife Coordination Act, the Endangered Species Act, the Clean Water Act, the Coastal Zone Management Act, the Wild and Scenic Rivers Act, the Federal Power Act or other applicable laws.
4. Ability to promote constructive communication about a disputed study.
Applicants must submit their applications along with the names and contact information of three references. Applicants will be individually notified of the Commission's decision.
(a) Within 20 days of the Study Plan Determination, any Federal agency with authority to provide mandatory conditions on a license pursuant to FPA Section 4(e), 16 U.S.C. 797(e), or to prescribe fishways pursuant to FPA Section 18, 16 U.S.C. 811, or any agency or Indian tribe with authority to issue a water quality certification for the project license under Section 401 of the Clean Water Act, 42 U.S.C. 1341, may file a notice of study dispute with respect to studies pertaining directly to the exercise of their authorities under Sections 4(e) and 18 of the Federal Power Act or Section 401 of the Clean Water Act.
(b) The notice of study dispute must explain how the disputing agency's or Indian tribe's study request satisfies the criteria set forth in § 5.9(b), and shall identify and provide contact information for the panel member designated by the disputing agency or Indian tribe, as discussed in paragraph (d) of this Section.
(c) Studies and portions of study plans approved in the Study Plan Determination that are not the subject of a notice of dispute shall be deemed to be approved, and the potential applicant shall proceed with those studies or portions thereof.
(d) Within 20 days of a notice of study dispute, the Commission will convene one or more three-person Dispute Resolution Panels, as appropriate to the circumstances of each proceeding. Each such panel will consist of:
(1) A person from the Commission staff who is not otherwise involved in the proceeding, and who shall serve as the panel chair;
(2) One person designated by the Federal or state agency or Indian tribe that filed the notice of dispute who is not otherwise involved in the proceeding; and
(3) A third person selected by the other two panelists from a pre-established list of persons with expertise in the resource area. The two panelists shall make every reasonable effort to select the third panel member. If however no third panel member has been selected by the other two panelists within 15 days, an appropriate third panel member will be selected at random from the list of technical experts maintained by the Commission.
(e) If more than one agency or Indian tribe files a notice of dispute with respect to the decision in the Preliminary Determination on any information-gathering or study request, the disputing agencies or Indian tribes must select one person to represent their interests on the panel.
(f) The list of persons available to serve as a third panel member will be posted, as revised from time-to-time, on the hydroelectric page of the Commission's website. A person on the list who is requested and willing to serve with respect to a specific dispute will be required to file with the Commission at that time a current statement of their qualifications, a statement that they have had no prior involvement with the proceeding in which the dispute has arisen, or other financial or other conflict of interest.
(g) All costs of the panel members representing the Commission staff and the agency or Indian tribe which filed the notice of dispute will be borne by the Commission or the agency or Indian tribe, as applicable. The third panel member will serve without compensation, except for certain allowable travel expenses as defined in 31 CFR part 301.
(h) To facilitate the delivery of information to the dispute resolution panel, the identity of the panel members and their addresses for personal service with respect to a specific dispute resolution will be posted on the hydroelectric page of the Commission's web site.
(i) No later than 25 days following the notice of study dispute, the potential applicant may file with the Commission and serve upon the panel members comments and information regarding the dispute.
(j) Prior to engaging in deliberative meetings, the panel shall hold a technical conference for the purpose of clarifying the matters in dispute with reference to the study criteria. The technical conference shall be chaired by the Commission staff member of the panel. It shall be open to all participants, and the panel shall receive information from the participants as it deems appropriate.
(k) No later than 50 days following the notice of study dispute, the panel shall make and deliver to the Director of the Office of Energy Projects a finding, with respect to each information or study request in dispute, concerning the extent to which each criteria set forth in § 5.9(b) is met or not met, and why, and make recommendations regarding the disputed study request based on its findings. The panel's findings and recommendations must be based on the record in the proceeding. The panel shall file with its findings and recommendations all of the materials received by the panel. Any recommendation for the potential applicant to provide information or a study must include the technical specifications, including data acquisition techniques and methodologies.
(1) No later than 70 days from the date of filing of the notice of study dispute, the Director of the Office of Energy Projects will review and consider the recommendations of the panel, and will issue a written
The following filings have been made with the Commission. The filings are listed in ascending order within each docket classification.
Take notice that on July 2, 2004, Green Mountain Power Corporation (GMP) tendered for filing an updated triennial market power analysis and modifications to its Wholesale Market-Based Rate Power Sales Tariff (FERC Electric Tariff, Original Volume No. 4) to incorporate Market Behavior Rules adopted by the Commission in Investigation of Terms and Conditions of Public Utility Market-Based Rate Authorizations, 105 FERC ¶ 61,218 (2003). GMP requests an effective date of July 3, 2004.
Take notice that on July 1, 2004, the New England Power Pool (NEPOOL) Participants Committee and ISO New England Inc. (ISO-NE) filed ISO-NE's Report on Alternatives to Full Nodal Pricing for Load in compliance with the Commission's order issued January 28, 2004, in Docket No. ER02-2330, New England Power Pool
The NEPOOL Participants Committee states that copies of the filings were sent to the NEPOOL Participants and the New England state governors and regulatory commissions.
Take notice that on July 2, 2004, ISO New England Inc. (ISO) submitted a compliance filing pursuant to Commission's order issued June 2, 2004, in Docket Nos. ER03-563-030 and EL04-102-000, 107 FERC ¶ 61,240.
ISO states that copies of the filing have been served on all parties to the above-captioned proceeding.
Take notice that on July 1, 2004, the New England Power Pool (NEPOOL) Participants Committee filed to terminate the membership of Providence Energy Services (Providence) and Gardiner Paperboard (Gardiner) in NEPOOL. The Participants Committee requests a July 1, 2004, effective date for the termination of the membership status of Providence and an August 1, 2004, effective date for the termination of the membership of Gardiner.
The Participants Committee states that copies of these materials were sent to the New England state governors and regulatory commissions and the Participants in NEPOOL.
Take notice that on July 2, 2004, Maine Public Service Company (MPS) submitted an amendment to its May 28, 2004, filing of minor revisions to its open access transmission tariff (OATT). MPS states that this amendment contained certain substitute revised tariff revisions. MPS requests an effective date of June 1, 2004.
MPS states that the copies of this filing were served on the Maine Public Utilities Commission, the Maine Public Advocate, current MPS open access transmission tariff customers, and the official service list compiled by the Secretary in this proceeding.
Take notice that on July 1, 2004, the New England Power Pool (NEPOOL) Participants Committee filed for acceptance materials to (1) permit NEPOOL to expand its membership to include Aleph One, Inc. (Aleph One) and Seneca Energy II, LLC (Seneca Energy); and (2) to terminate the memberships of Virginia Electric and Power Company (Virginia Power) and Power Development Company, LLC (PDC) in NEPOOL. The Participants Committee requests the following effective dates: June 1, 2004, for the termination of Virginia Power and PDC; and July 1, 2004, for the commencement of participation in NEPOOL by Aleph One and Seneca Energy.
The Participants Committee states that copies of these materials were sent to the New England state governors and regulatory commissions and the Participants in NEPOOL.
Take notice that on July 2, 2004, PJM Interconnection, L.L.C. (PJM), submitted for filing an executed interconnection service agreement between PJM and ConocoPhillips Company. PJM requests an effective date of June 2, 2004.
PJM states that copies of this filing were served upon the parties to the agreement and the state regulatory commissions within the PJM region.
Take notice that on July 2, 2004, PJM Interconnection, L.L.C. (PJM) filed revisions to the PJM Open Access Transmission Tariff (PJM Tariff) and Amended and Restated Operating Agreement of PJM Interconnection, L.L.C. (Operating Agreement) to allocate to loads in each transmission zone the costs of synchronous condensers acting at PJM's direction. PJM requests an effective date of September 1, 2004.
PJM states that copies of the filing were served on all PJM members and the utility regulatory commissions in the PJM region.
Take notice that on July 2, 2004, PJM Interconnection, L.L.C. (PJM), submitted an executed interconnection service agreement and an executed construction service agreement among PJM, PPL Distributed Generation, LLC, and Public Service Electric and Gas Company. PJM requests an effective date of June 4, 2004.
PJM states that copies of this filing were served upon the parties to the agreements and the state regulatory commissions within the PJM region.
Any person desiring to intervene or to protest this filing should file with the Federal Energy Regulatory Commission,
In accordance with the National Environmental Policy Act of 1969 and the Federal Energy Regulatory Commission's (Commission) regulations, 18 CFR 380 (Order No. 486; 52 FR 47897), the staff of the Office of Energy Projects (staff) has reviewed the application for a subsequent license for the De Pere Hydroelectric Project No. 4914 and has prepared an Environmental Assessment (EA) for the project. The De Pere Hydroelectric Project is located at the U.S. Army Corps of Engineers' (COE) De Pere Dam, on the Fox River, in the City of De Pere, Brown County, Wisconsin.
The EA contains the staff's analysis of the potential environmental impacts of the project and concludes that licensing the project, with appropriate environmental protective measures, would not constitute a major Federal action that would significantly affect the quality of the human environment.
A copy of the EA is available for review at the Commission in the Public Reference Room, located at 888 First Street, NE., Room 2A, Washington, DC 20426, or may be viewed on the Commission's Web site at
You may also register online at
Because staff intends this to be the only EA prepared for this project, any comments on this EA should be filed within 30 days from the date of this notice and should be addressed to: Magalie R. Salas, Secretary, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. Please affix “De Pere Hydroelectric Project No. 4914-010” to all comments. For further information, contact Peter Leitzke at (202) 502-6059 or
Comments may be filed electronically via the Internet in lieu of paper. The Commission strongly encourages electronic filings.
In accordance with the National Environmental Policy Act of 1969 and the Federal Energy Regulatory Commission's (Commission) regulations, 18 CFR part 380 (Order No. 486, 52 FR 47897), the Office of Energy Projects' staff has prepared an Environmental Assessment (EA) for an application for surrender of exemption for the Pittsfield Project. The Pittsfield Project, FERC No. 6338, is located on the Suncook River in Merrimack County, New Hampshire.
The EA contains the staff's analysis of the potential environmental impacts of the proposal and concludes that approval of the proposal would not constitute a major Federal action significantly affecting the quality of the human environment.
A copy of the EA is available for review at the Commission in the Public Reference Room, or it may be viewed on the Commission's Web site at
For further information, contact Rebecca Martin at 202-502-6012.
The staff of the Federal Energy Regulatory Commission (FERC or Commission) will prepare an environmental assessment (EA) that will discuss the environmental impacts of the Boehm Storage Field Abandonment and Conversion Project involving abandonment, conversion, and/or reclassification of certain natural gas storage wells and gathering lines by Colorado Interstate Gas Company (CIG) in Morton County, Kansas.
If you are a landowner receiving this notice, you may be contacted by a company representative about existing wells, or storage gathering pipelines. CIG proposes to abandon all affected gathering lines in place.
A fact sheet prepared by the FERC entitled “An Interstate Natural Gas Facility On My Land? What Do I Need To Know?” was attached to the project notice CIG provided to landowners. This fact sheet addresses a number of typically asked questions, including how to participate in the Commission's proceedings. It is available for viewing on the FERC Internet Web site (
CIG proposes to plug and abandon nine wells and to convert or reclassify an additional 12 wells within the Boehm Storage Field. These activities are necessary for CIG to comply with gas storage regulations adopted by the Kansas Corporation Commission (KCC) on July 1, 2002, and to allow CIG to operate the Boehm Storage Field on a more efficient basis. Specifically, CIG is required to obtain a Gas Storage Operating Permit for the Boehm Storage Field from the KCC. In order to comply with requirements of the permit, any well that does not demonstrate mechanical integrity must either be repaired or plugged and abandoned.
Specifically, CIG proposes to plug and abandon the following wells for the reasons listed:
• Well Nos. 1, 11, 17, and 30, due to subsurface conditions, and in concert with the KCC's new regulations;
• Well Nos. 6, 18, 29, and 43. With the continued depletion of the Keyes Reservoir, these observation wells are no longer needed; and
• Well No. 38, designated as “G” observation well. This well is located at some distance from the lateral extent of the “G” storage zone in Boehm.
In addition, CIG also proposes to:
• Convert and reclassify four Keyes observation wells (Well Nos. 25, 37, 39, and 42) into “G” observation wells;
• Convert and reclassify three “G” injection/withdrawal wells (Well Nos. 36, 44, and 47) and one Keyes observation well (Well No. 21) to “G” Reservoir observation wells; and
• Convert and reclassify three Keyes blowdown wells (Well Nos. 23, 26, and 34) as “G” injection/withdrawal wells; and
• Convert and reclassify one Keyes blowdown well (Well No. 35) as a Keyes observation well.
The location of the project facilities is shown in appendix 1.
The proposed activities would temporarily impact approximately 43.5 acres, which includes a construction area of 300 feet by 300 feet (2.07 acres) for each well. A significant portion of this area (43.0 acres) would be used for staging and work area purposes only. No grading or vegetation removal would be required. Approximately 0.4 acre would be permanently impacted by the proposed activities, which includes a bellhole of approximately 25 feet by 25 feet (0.02 acre) around each well.
No new access roads or expansion of existing access roads would be required for project activities. No new permanent right-of-way, extra temporary work areas, or storage areas have been identified for the project.
The National Environmental Policy Act (NEPA) requires the Commission to take into account the environmental impacts that could result from an action whenever it considers the issuance of a Certificate of Public Convenience and Necessity. NEPA also requires us to discover and address concerns the public may have about proposals. This process is referred to as “scoping”. The main goal of the scoping process is to focus the analysis in the EA on the important environmental issues. By this Notice of Intent, the Commission staff requests public comments on the scope of the issues to address in the EA. All comments received are considered during the preparation of the EA. State and local government representatives are encouraged to notify their constituents of this proposed action and encourage them to comment on their areas of concern.
In the EA, we will discuss impacts that could occur as a result of the proposed project under these general headings:
• Geology and soils.
• Water resources.
• Land use.
• Cultural resources.
• Vegetation and wildlife.
• Air quality and noise.
• Endangered and threatened species.
Our independent analysis of the issues will be included in the EA. Depending on the comments received during the scoping process, the EA may be published and mailed to federal, state, and local agencies, public interest groups, interested individuals, affected landowners, newspapers, libraries, and the Commission's official service list for this proceeding. A comment period will be allotted for review if the EA is published. We will consider all comments on the EA before we make our recommendations to the Commission.
To ensure your comments are considered, please carefully follow the instructions in the public participation section below.
You can make a difference by providing us with your specific comments or concerns about the project. By becoming a commentor, your concerns will be addressed in the EA and considered by the Commission. You should focus on the potential environmental effects of the proposal, alternatives to the proposal, and measures to avoid or lessen environmental impact. The more specific your comments, the more useful they will be. Please carefully follow these instructions to ensure that your comments are received in time and properly recorded:
• Send an original and two copies of your letter to: Magalie R. Salas, Secretary, Federal Energy Regulatory Commission, 888 First St., NE., Room 1A, Washington, DC 20426.
• Label one copy of the comments for the attention of Gas Branch 3.
• Reference Docket No. CP04-362-000.
• Mail your comments so that they will be received in Washington, DC on or before August 9, 2004.
We will include all comments that we receive within a reasonable time frame in our environmental analysis of this project. To expedite our receipt and consideration of your comments, the Commission strongly encourages electronic submission of any comments on this project.
We may mail the EA for comment. If you are interested in receiving it, please return the Information Request (appendix 4). If you do not return the Information Request, you will be taken off the mailing list.
In addition to involvement in the EA scoping process, you may want to become an official party to the proceeding known as an “intervenor”. Intervenors play a more formal role in the process. Among other things, intervenors have the right to receive copies of case-related Commission documents and filings by other intervenors. Likewise, each intervenor must provide 14 copies of its filings to the Secretary of the Commission and must send a copy of its filings to all other parties on the Commission's service list for this proceeding. If you want to become an intervenor you must file a motion to intervene according to Rule 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.214) (
Affected landowners and parties with environmental concerns may be granted intervenor status upon showing good cause by stating that they have a clear and direct interest in this proceeding which would not be adequately represented by any other parties. You do not need intervenor status to have your environmental comments considered.
An effort is being made to send this notice to all individuals, organizations, and government entities interested in and/or potentially affected by the proposed project. This includes all landowners whose property may be used temporarily for project purposes. By this notice we are also asking governmental agencies, especially those in appendix 3, to express their interest in becoming cooperating agencies for the preparation of the EA.
Additional information about the project is available from the Commission's Office of External Affairs, at 1-866-208-FERC (3372) or on the FERC Internet website (
In addition, the Commission now offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries and direct links to the documents. Go to
Finally, public meetings or site visits will be posted on the Commission's calendar located at
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n. Comments, Protests, or Motions to Intervene—Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.
o. Filing and Service of Responsive Documents—Any filings must bear in all capital letters the title “COMMENTS”, “RECOMMENDATIONS FOR TERMS AND CONDITIONS”, “PROTEST”, OR “MOTION TO INTERVENE”, as applicable, and the Project Number of the particular application to which the filing refers (P-2403-048, P-2534-068, P-2666-023 and/or P-2712-055). All documents (original and eight copies) should be filed with: Magalie R. Salas, Secretary, Federal Energy Regulatory Commission, 888 First Street, NE., Washington DC 20426. A copy of any motion to intervene must also be served upon each representative of the Applicant specified in the particular application.
p. Agency Comments—Federal, state, and local agencies are invited to file comments on the described application. A copy of the application may be obtained by agencies directly from the Applicant. If an agency does not file comments within the time specified for filing comments, it will be presumed to have no comments. One copy of an agency's comments must also be sent to the Applicant's representatives.
q. Comments, protests and interventions may be filed electronically via the Internet in lieu of paper. See, 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site at
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n. Comments, Protests, or Motions to Intervene—Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.
o. Filing and Service of Responsive Documents—Any filings must bear in all capital letters the title “COMMENTS”, “RECOMMENDATIONS FOR TERMS AND CONDITIONS”, “PROTEST”, OR “MOTION TO INTERVENE”, as applicable, and the Project Number of the particular application to which the filing refers (P-2600-056). All documents (original and eight copies) should be filed with: Magalie R. Salas, Secretary, Federal Energy Regulatory Commission, 888 First Street, NE., Washington DC 20426. A copy of any motion to intervene must also be served upon each representative of the Applicant specified in the particular application.
p. Agency Comments—Federal, state, and local agencies are invited to file comments on the described application.
q. Comments, protests and interventions may be filed electronically via the Internet in lieu of paper. See, 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site at
Take notice that the following Offer of Settlement has been filed with the Commission and is available for public inspection.
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Comments may be filed electronically via the Internet in lieu of paper. See 18 CFR 395.2001(a)(1)(iii) and the instructions of the Commission's Web site (
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You may also register online at
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:
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All documents (original and eight copies) should be filed with: Magalie R. Salas, Secretary, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. Comments, protests, and interventions may be filed electronically via the Internet in lieu of paper; see 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site under the “e-Filing” link. The Commission strongly encourages electronic filings. Please include the project number (P-7115-035) on any comments or motions filed.
The Commission's Rules of Practice and Procedure require all interveners filing a document with the Commission to serve a copy of that document on each person in the official service list for the project. Further, if an intervener files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.
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m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
n. Comments, Protests, or Motions to Intervene—Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.
o. Filing and Service of Responsive Documents—Any filings must bear in all capital letters the title “COMMENTS”, “PROTEST”, OR “MOTION TO INTERVENE”, as applicable, and the Project Number of the particular application to which the filing refers. A copy of any motion to intervene must also be served upon each representative of the Applicant specified in the particular application.
p. Agency Comments—Federal, State, and local agencies are invited to file comments on the described application. A copy of the application may be obtained by agencies directly from the Applicant. If an agency does not file comments within the time specified for filing comments, it will be presumed to have no comments. One copy of an agency's comments must also be sent to the Applicant's representatives.
On May 28, 2004, the Commission issued a “Notice Of Technical Conference And Request For Written Comments On Credit-Related Issues For Electric Transmission Providers, Independent System Operators, and Regional Transmission Organizations” in the above-referenced proceeding.
The following dockets should have been included in the caption of the notice: ISO New England, Inc., ER04-121-001; New York Independent System Operator, Inc., ER03-552-006 and ER03-984-006; New England Power Pool, ER04-984-000; Midwest Independent Transmission System Operator, Inc., ER04-691-000 and EL04-104-000; PJM Interconnection, LLC, ER03-1117-001; and PJM Interconnection, LLC, ER03-1101-002 and ER03-1101-003. The notice is hereby revised to include those dockets in the caption of the notice, because they involve pending credit-related issues that might be touched upon at the technical conference.
Electric Creditworthiness Standards—Docket No. AD04-8-000
ISO New England, Inc.—Docket No. ER04-121-001.
New York Independent System Operator, Inc.—Docket Nos. ER03-552-009 and ER03-984-007.
New England Power Pool—Docket No. ER04-984-000.
Midwest Independent Transmission System Operator, Inc.—Docket Nos. ER04-691-000 and EL04-104-000.
PJM Interconnection, LLC—Docket No. ER03-1117-001.
PJM Interconnection, LLC—Docket Nos. ER03-1101-002 and ER03-1101-003.
Environmental Protection Agency.
Request for Nominations for Clean Air Excellence Awards.
The Environmental Protection Agency (EPA) established the Clean Air Excellence Awards Program in February, 2000. This is an annual awards program to recognize outstanding and innovative efforts that support progress in achieving clean air. This notice announces the competition for the Year 2004 program.
All submission of entries must be postmarked by September 17, 2004
Clean Air Excellence Awards, Attn Mr. Pat Childers, U.S. EPA Office of Air and Radiation (6102A), 1200 Pennsylvania Avenue, NW., Washington, DC 20004.
Concerning this awards program please use the CAAAC Web site
Environmental Protection Agency (EPA).
Notice of document availability.
EPA is announcing availability of a memorandum entitled “Allocation of Fiscal Year 2004 Operator Training Grants” issued on July 2, 2004. This memorandum provides National guidance for the allocation of funds used under section 104(g)(l) of the Clean Water Act.
Municipal Assistance Branch, U.S. EPA, 1200 Pennsylvania Avenue, NW., (4204-M), Washington, DC, 20460.
Margaret Dodds, (202) 564-0728 or
The subject memorandum may be viewed and downloaded from EPA's homepage,
Environmental Protection Agency(EPA).
Notice.
This notice announces Agency approval of applications to register the pesticide products Yeast Hydrolysate Liquid and KeyPlex 350 containing an active ingredient not included in any previously registered product pursuant to the provisions of section 3(c)(5) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended.
Diana M. Horne, Biopesticides and Pollution Prevention Division (7511C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-8367; e-mail address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:
• Crop production (NAICS 111)
• Animal production (NAICS 112)
• Food manufacturing (NAICS 311)
• Pesticide manufacturing (NAICS 32532)
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
1.
In accordance with section 3(c)(2) of FIFRA, a copy of the approved label, the list of data references, the data and other scientific information used to support registration, except for material specifically protected by section 10 of FIFRA, are also available for public inspection. Requests for data must be made in accordance with the provisions of the Freedom of Information Act and must be addressed to the Freedom of
A paper copy of the fact sheet, which provides more detail on this registration, may be obtained from the National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161.
2.
An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at
The Agency approved the application after considering all required data on risks associated with the proposed use of Yeast Extract Hydrolysate from
EPA issued a notice, published in the
The following products were approved on February 19, 2004.
1. The manufacturing use product, Yeast Hydrolysate Liquid, containing 2.5% active ingredient (EPA Registration Number 73512-2) for use in the management of plant diseases.
2. The end use product, KeyPlex 350, containing 0.063% active ingredient (EPA Registration Number 73512-1 for use in the management of plant diseases.
Environmental protection, Chemicals, Pesticides and pests.
Environmental Protection Agency (EPA).
Notice.
EPA has granted an experimental use permit (EUP) to the following pesticide applicant. An EUP permits use of a pesticide for experimental or research purposes only in accordance with the limitations in the permit.
Diana M. Horne, Biopesticides and Pollution Prevention Division (7511C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-8367; e-mail address:
This action is directed to the public in general. Although this action may be of particular interest to those persons who conduct or sponsor research on pesticides, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the information in this action, consult the person listed under
1.
2.
An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at
EPA has issued the following EUP:
7 U.S.C. 136c.
Environmental protection, Experimental use permits.
U.S. Environmental Protection Agency, National Health and Environmental Effects Research Laboratory.
Notice.
This review will be conducted, and the information collected, by the Epidemiology and Biomarkers Branch, Human Studies Division, National Health and Environmental Effects Research Laboratory, Office of Research and Development, U.S. Environmental Protection Agency (EPA). Product information packages collected for review are strictly voluntary. This notice is a result of Section 3(a)(v)(1) of the Beaches Environmental Assessment and Coastal Health Act of 2000 and the strategic plan for EPA's Office of Research and Development (ORD) and the Office of Water entitled “Action Plan for Beaches and Recreational Water.”
Current EPA guidelines (Section 303(c) Clean Water Act) recommend the use of cultural methods for E. coli and enterococci to measure recreational water quality. These methods produce results in 24 hours creating a delayed response for recreational water managers. This shortcoming in the current practices for measuring recreational water quality has led EPA to consider new technology and indicators that will provide rapid measurement of water quality (preferably 2 hours or less). This will give vendors the opportunity to showcase technology and determine needs for current industry.
Packages submitted should include the following information (if applicable):
1. Cost of the equipment/instrument?
2. Cost of supplies
3. Commercially available? How long has it been on the market? Are supplies commercially available?
4. Shipping time?
5. Is it portable? Laboratory or field use?
6. Skill level for operators? Do they need special training? Is it included in purchase?
7. Computer needed? Is it included? Specifications?
8. Specificity for target organisms? False-positive and false-negative rates?
9. Limit of detection?
10. Types of samples tested (primarily, but not limited to, types of water samples)?
11. Volume of sample required?
12. Detect live organisms?
13. Developed/validated method or experimental method?
14. Analysis time for one sample?
15. Preparation time for one sample?
16. How many samples can be analyzed per day?
17. Quality control procedures?
18. Is the system sterile? Cleaning and sanitization procedures?
19. References where equipment/instrument was used?
20. Data form (tables, graphs, etc.) and examples?
21. Can data be stored in the equipment/instrument, if portable?
22. Include brochures and pictures/photos/schematics.
23. Warranty and repair services?
24. Any distinctive elements that uniquely qualify this instrument or methods above others.
Review of information packages will begin on July 30, 2004. All interested parties should submit packages on or before March 31, 2005.
Elizabeth Sams, (919), 843-3161, FAX: (919) 966-0655, E-mail:
The Federal Communications Commissions, as part of its continuing effort to reduce paperwork burden invites the general public and other Federal agencies to take this opportunity to comment on the following information collection, as required by the Paperwork Reduction Act of 1995, Public Law 104-13. An agency may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a valid control number. Comments are requested concerning (a) whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimate; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology.
Written comments should be submitted on or before August 13, 2004. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all comments to Les Smith, Federal Communications Commission, Room 1-A804, 445 12th
For additional information or copy of the information collection(s) contact Les Smith at (202) 418-0217 or via the Internet at
The Federal Communications Commissions, as part of its continuing effort to reduce paperwork burden invites the general public and other Federal agencies to take this opportunity to comment on the following information collection, as required by the Paperwork Reduction Act of 1995, Public Law 104-13. An agency may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a valid control number. Comments are requested concerning (a) whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's
Written comments should be submitted on or before August 13, 2004. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all comments to Les Smith, Federal Communications Commission, Room 1-A804, 445 12th Street, SW., Washington, DC 20554 or via the Internet to
For additional information or copy of the information collection(s) contact Les Smith at (202) 418-0217 or via the Internet at
The Federal Communications Commissions, as part of its continuing effort to reduce paperwork burden invites the general public and other Federal agencies to take this opportunity to comment on the following information collection, as required by the Paperwork Reduction Act of 1995, Public Law 104-13. An agency may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a valid control number. Comments are requested concerning (a) whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimate; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology.
Written comments should be submitted on or before August 13, 2004. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all comments to Les Smith, Federal Communications Commission, Room 1-A804, 445 12th Street, SW., Washington, DC 20554 or via the Internet to
For additional information or copy of the information collection(s) contact Les Smith at (202) 418-0217 or via the Internet at
Licensees/permittees use FCC Form 301 to apply for authority to construct a new commercial AM, FM, or TV broadcast station or to make changes to the existing facilities of such a station. In addition, FM licensees/permittees may use Form 301 to request upgrades on adjacent and co-channels, modifications to adjacent channels of the same class, and downgrades to adjacent channels without first submitting a petition for rulemaking. Applicants using this “one step” process must demonstrate that a suitable site exists, which complies with allotment standards,
Respondents: Business or other for-profit entities; and Not-for-profit institutions.
Applicants must file FCC Form 314 and applicable exhibits/explanations when applying for consent to assignment of an AM, FM, or TV broadcast station construction permit or license. In addition, the applicant must notify the Commission when an approved assignment of a broadcast station construction permit or license has been consummated.
Under 47 CFR 73.3580, applicants must publish a notice in a local paper of general circulation when filing for assignment of all licenses/permits. A copy of the notice is to be kept with the application in the station's public file. Additionally, an applicant for assignment of license must broadcast the same notice from the station in the second week immediately following the tendering for the application filing. On April 4, 2000, the Commission adopted a Report and Order in MM Docket 95-31,
Applicants must file FCC Form 315 and applicable exhibits/explanations when applying for transfer of control of a corporation holding an AM, FM, or TV broadcast station construction permit or license. In addition, the applicant must notify the Commission when an approved transfer of control of a broadcast station construction permit or license has been consummated.
Under 47 CFR 73.3580, applicants must publish a notice in a local paper of general circulation when filing all applications for transfer of control any license/permit. A copy of the public notice is to be kept with the application in the station's public file. Additionally, an applicant for transfer of control of license must broadcast the same notice from the station in the second week immediately following the tendering for the application filing.
On April 4, 2000, the Commission adopted a Report and Order in MM Docket 95-31,
The Federal Communications Commissions, as part of its continuing effort to reduce paperwork burden invites the general public and other Federal agencies to take this opportunity to comment on the following information collection, as required by the Paperwork Reduction Act of 1995, Public Law 104-13. An agency may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a valid control number. Comments are requested concerning (a) whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimate; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology.
Written comments should be submitted on or before August 13, 2004. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all comments to Les Smith, Federal Communications Commission, Room 1-A804, 445 12th Street, SW., Washington, DC 20554 or via the Internet to
For additional information or copy of the information collection(s) contact Les Smith at (202) 418-0217 or via the Internet at
On February 28, 2001, the FCC released a Memorandum Opinion and Order,
Under 47 CFR 73.3580, applicants must publish a notice in a newspaper of general circulation of the filing of all applications for new or major changes in facilities for at least twice a week for two consecutive weeks in a three-week period. This notice must be completed within 30 days of the tendering of the application. A copy of this notice and the applications must be placed in the station's public inspection file.
The Federal Communications Commission, as part of its continuing effort to reduce paperwork burden invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s), as required by the Paperwork Reduction Act (PRA) of 1995, Public Law 104-13. An agency may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a valid control number. Comments are requested concerning (a) whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimate; (c) ways to enhance the quality, utility and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology.
Written Paperwork Reduction (PRA) comments should be submitted on or before August 13, 2004. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all Paperwork Reduction Act (PRA) comments to Judith B. Herman, Federal Communications Commission, Room 1-C804, 445 12th Street, SW., Washington, DC 20554 or via the Internet to
For additional information or copies of the information collection(s), contact Judith B. Herman at (202) 418-0214 or via the Internet at
The Federal Communications Commission, as part of its continuing effort to reduce paperwork burden invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s), as required by the Paperwork Reduction Act (PRA) of 1995, Public Law 104-13. An agency may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a valid control number. Comments are requested concerning (a) whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimate; (c) ways to enhance the quality, utility and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology.
Written Paperwork Reduction (PRA) comments should be submitted on or before September 13, 2004. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all Paperwork Reduction Act (PRA) comments to Judith B. Herman, Federal Communications Commission, Room 1-C804, 445 12th Street, SW., Washington, DC 20554 or via the Internet to
For additional information or copies of the information collection(s), contact Judith B. Herman at (202) 418-0214 or via the Internet at
The Federal Communications Commissions, as part of its continuing effort to reduce paperwork burden invites the general public and other Federal agencies to take this opportunity to comment on the following information collection, as required by the Paperwork Reduction Act of 1995, Public Law 104-13. An agency may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a valid control number. Comments are requested concerning (a) whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimate; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology.
Written comments should be submitted on or before August 13, 2004. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all comments to Les Smith, Federal Communications Commission, Room 1-A804, 445 12th Street, SW., Washington, DC 20554 or via the Internet to
For additional information or copy of the information collection(s) contact Les Smith at (202) 418-0217 or via the Internet at
Federal Communications Commission.
Notice.
The Wireless Telecommunications Bureau (“WTB” or “Bureau”) announces the details of the licensing and interim link registration process, including the start date for filing applications for non-exclusive nationwide licenses in the 71-76, 81-86, 92-94.0 and 94.1-95 GHz bands.
The start date for filing applications for non-exclusive nationwide licenses is June 21, 2004 and, the start date for licensees to register individual links under an interim registration process begins at 9 a.m. (e.d.t.) on July 19, 2004.
Federal Communications Commission, 445 12th Street, SW., Washington, DC 20554.
Cheryl Black or Stephen Buenzow, Broadband Division, WTB, 717-338-2687 or questions regarding the application filing and link registration procedure outlined in the Public Notice may be directed to the ULS Hotline at 1-888-CallFCC Option #2.
This is a synopsis of the Commission's Public Notice, DA 04-1463, released May 26, 2004, the full text of this Public Notice is available for inspection and copying during normal business hours in the FCC Reference Center, Room CY-A-257, 445 12th Street, SW., Washington DC 20554. The complete text may also be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., (BCPI), Portals II, 445 12th Street, SW., Room CY-B402, Washington, DC. The complete item is also available on the Commission's Web site at
On October 16, 2003, the Commission adopted a
In the
A license for the Millimeter Wave 70/80/90 GHz Radio Service will consist of a non-exclusive nationwide license, combined with site-based links obtained through a link registration process. All interested parties must have a non-exclusive nationwide license prior to registering a link whether under the interim or permanent link registration processes described herein. The non-exclusive nationwide license does
Applicants for non-exclusive nationwide licenses are encouraged to electronically file FCC Form 601 using the Universal Licensing System (ULS). Applicants can access the ULS Web site at
Applicants for non-exclusive nationwide licenses will be required to file FCC Form 601 Main Form and Schedule B. Applicants should specify that they are filing an application in the MM—Millimeter Wave 70/80/90 Radio Service and specify the purpose of the application as New (NE). When filing electronically, the ULS will automatically load FCC Form 601.
Applications are assigned file numbers and all applications (and major amendments thereto) that are accepted for filing are listed on the Bureau's weekly public notice of such applications. An application may be granted at any time if the Bureau finds that it meets all of the Commission's requirements (
Applications to provide non-common carrier service or for private, internal communications (Codes “N” and “P,” respectively on FCC Form 601 Item 35) may be granted anytime after they are accepted for filing. Applications that include a request for common carrier regulatory status (Code “C,” FCC Form 601 Item 35) will
Modifications to the non-exclusive nationwide license will be limited to data on the FCC Form 601 Main Form. Any such modifications should be filed on FCC Form 601 and should specify the purpose of the filing as modification (MD). Modifications to FCC Form 601 Schedule B data will not be permitted. Modifications to the FCC Form 601 Main Form data will not affect the interference protection date for individual links registered under that license. License modifications must be filed independent of any filing involving registration of individual links.
Licensees may assign or transfer their non-exclusive nationwide license using FCC Form 603. Pursuant to the
Parties may file applications for non-exclusive nationwide licenses starting on June 21, 2004. Applications filed before June 21, 2004, will be dismissed.
As noted above, the non-exclusive nationwide license is a required prerequisite for registering individual links. Therefore, individual links cannot be registered until a geographical (nationwide) license is obtained (see above).
In Appendix C of the
The process for link registration and coordination with NTIA prior to the implementation of NTIA's automated system and the appointment of third party database managers is referred to in this Pubic Notice as the “interim link registration process.” The process for link registration and coordination with NTIA subsequent to the implementation of NTIA's automated system is referred to in this Public Notice as the “permanent link registration process.”
•
In the
•
During the interim link registration process, individual links must be registered with the Commission in ULS. Links will be coordinated with NTIA through IRAC using the existing IRAC coordination process. FCC Form 601 has been revised to add Schedule M (Schedule for Link registration)
When an individual link has been successfully coordinated with IRAC and is approved the licensee will be notified by letter that their link registration has been posted in ULS as accepted. Individual link registrations will be available for public inspection through ULS electronically. However, the printed copy of the non-exclusive nationwide license will not be updated to reflect link registrations and will not be re-issued when individual links are registered with that call sign.
•
The FCC will coordinate links with NTIA/IRAC. Licensees need not provide any special information or take any
•
In establishing the link registration process, the Commission adopted the standard by which interference disputes are to be resolved. Specifically, the Commission stated that, “[f]or the purpose of non-Federal Government licensee interaction with each other, instead of requiring prior coordination of all prospective links, we will institute the link registration mechanism * * * which will provide priority based on date/time of application in any cases in which interference may arise.” Thus, during the interim link registration process, the date on which the FCC Form 601 Main Form and Schedule M are submitted to the Commission in a state acceptable for filing will be used as the first-in-time interference protection date while the application is coordinated with NTIA through the existing IRAC coordination process. If the link is cleared via the coordination process, interference protection will become effective based on the first-in-time date established by the aforementioned filing date of the FCC Form 601 Main Form and Schedule M. If at any time the link registration is found to be defective or cannot be successfully coordinated with IRAC, the link registration will be dismissed and the interference protection date rendered ineffective. If the applicant re-files its link registration request, the interference protection date will be established by the date that the new request is received at the Commission in a state acceptable for filing.
During the coordination process, licensees may be asked to provide additional information to facilitate coordination with NTIA. In these circumstances the licensee will be given 60 days to provide the requested information. If the licensee responds with the requested information within the required time frame, and does not make any changes to the data on FCC Form 601 Schedule M, the initial first-in-time interference protection date will be preserved.
Pursuant to our delegated authority set forth in the
Should a licensee receive interference from another licensee, the licensee experiencing the harmful interference shall follow the interference resolution procedures outlined in 47 CFR § 101.105 of the Commission's Rules (
•
Licensees must electronically file FCC Form 601 Main Form and Schedule M to modify the technical data on an individual link registration. The FCC Form 601 Main Form should indicate a purpose of “Register Link/Location” (RL). On FCC Form 601 Schedule M, the licensee should specify the action as Modify (M) and identify the link registration that is being changed. To amend the technical data on an individual link registration which has not yet been approved, licensees will be required to file FCC Form 601 Main Form and Schedule M. The FCC Form 601 Main Form should indicate a purpose of Amendment (AM) and identify the file number of the pending link registration filing that is being changed. Under electronic filing, the previously entered data from FCC Form 601 Schedule M will be displayed and the licensee will be allowed to change the data.
•
Transfer or assignment of a non-exclusive nationwide license, unless otherwise specified, will include all links registered under that call sign. The ability to file for partial assignment of individual link registrations will not be available in ULS on July 19, 2004, the date that ULS will be ready to accept link registration filings from licensees. However, by future Public Notice, the Bureau will announce, pursuant to its delegated authority,
Under the permanent process, link registrations will be made on a non-FCC registration database and NTIA will
The Bureau is reviewing four proposals, and comments thereto, submitted in response to the
NTIA is in the process of developing its automated coordination system, which will enable near real time coordination of non-Federal Government links with Federal Government operations. As indicated in the
The effective date and additional details of the permanent process described herein will be announced by future Public Notice after the prerequisites discussed above have been completed.
•
•
The 70-80-90 GHz bands are licensed for microwave point-to-point operations (common carrier or private operational fixed) which are subject to filing fees under § 1.1102 and regulatory fees under §§ 1.1152 or 1.1154, as applicable.
• New license applications must use fee type code CJPR.
• Modification of license applications must use fee code CJPM. Currently, the filing fee is $220.
• Assignments of Authorization and Transfers of Control of license applications must use fee code CCPM for the first call listed on the application and CAPM for each additional call sign listed. Currently, the filing fee is $80 for the first call sign and $50 for each additional call sign.
• Individual link registrations on ULS are not subject to a filing fee.
Rules relating to marketing of radio frequency devices and equipment authorization procedures contained in part 2, subparts I and J, respectively, apply to licensed and unlicensed equipment operating in the 71-95 GHz bands.
The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board’s Regulation Y (12 CFR 225.41) to acquire a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the office of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than July 28, 2004.
Board of Governors of the Federal Reserve System, July 8, 2004.
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The application also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Additional information on all bank holding companies may be obtained from the National Information Center website at
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than August 6, 2004.
In connection with this application, Applicants also have applied to engage
Board of Governors of the Federal Reserve System, July 8, 2004.
In accordance with § 271.25 of its rules regarding availability of information (12 CFR part 271), there is set forth below the domestic policy directive issued by the Federal Open Market Committee at its meeting held on May 4, 2004.
The Federal Open Market Committee seeks monetary and financial conditions that will foster price stability and promote sustainable growth in output. To further its long-run objectives, the Committee in the immediate future seeks conditions in reserve markets consistent with maintaining the federal funds rate at an average of around 1 percent.
By order of the Federal Open Market Committee, July 2, 2004.
9 a.m. (e.d.t.); July 19, 2004.
4th Floor Conference Room, 1250 H Street, NW., Washington, DC.
Federal Retirement Thrift Investment Board.
Notice; correction.
The Federal Retirement Thrift Investment Board published a notice in the
7. Procurement.
Thomas J. Trabucco, Director, Office of External Affairs, (202) 942-1640.
Federal Trade Commission (“FTC” or “Commission”).
Notice.
The information collection requirements described below will be submitted to the Office of Management and Budget (“OMB”) for review, as required by the Paperwork Reduction Act (“PRA”). The FTC is seeking public comments on its proposal to extend through September 30, 2007 the current PRA clearance for information collection requirements contained in (1)
Comments must be submitted on or before September 13, 2004.
Interested parties are invited to submit written comments. Comments should refer to “Warranty Rules: Paperwork Comment, P044403” to facilitate the organization of comments. A comment filed in paper form should include this reference both in the text and on the envelope, and should be mailed or delivered to the following address: Federal Trade Commission/Office of the Secretary, Room H-159, 600 Pennsylvania Avenue, NW., Washington, DC 20580. If the comment contains any material for which confidential treatment is requested, it must be filed in paper form, and the first page of the document must be clearly labeled “Confidential.”
The FTC Act and other laws the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. All timely and responsive public comments will be considered by the Commission, and will be available to the public on the FTC Web site, to the extent practicable, at
Requests for additional information or copies of the proposed information requirements should be addressed to Carole Danielson, Investigator, Division of Marketing Practices, Bureau of Consumer Protection, Federal Trade Commission, Room H-238, 600 Pennsylvania Ave., NW., Washington, DC 20580, (202) 326-3115.
Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from OMB for each collection of information they conduct or sponsor. “Collection of information” means agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. 44 U.S.C. 3502(3), 5 CFR 1320.3(c). As required by section 3506(c)(2)(A) of the PRA, the FTC is providing this opportunity for public comment before requesting that OMB extend the existing paperwork clearance for the Warranty Rules.
The FTC invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
The Warranty Rules implement the Magnuson-Moss Warranty Act, 15 U.S.C. 2301
Among other things, the Rule requires sellers to make the text of the warranty readily available either by (1) displaying it in close proximity to the product or (2) furnishing it on request and posting signs in prominent locations advising consumers that the warranty is available. The Rule requires warrantors to provide materials to enable sellers to comply with the Rule's requirements, and also sets out the methods by which warranty information can be made available before the sale if the product is sold through catalogs, mail order, or door-to-door sales.
The Informal Dispute Settlement Rule contains extensive procedural standards for IDSMs. These standards include requirements concerning the mechanism's structure (
This rule applies only to those firms that choose to be bound by it by placing a prior resort requirement in their written consumer product warranties. Neither the Rule nor the Act requires warrantors to set up IDSMs. Furthermore, a warrantor is free to set up an IDSM that does not comply with this rule as long as the warranty does not contain a prior resort requirement.
The above estimate is derived as follows. Based on conversations with various warrantors' representatives over the years, staff has concluded that eight hours per year is a reasonable estimate of warrantors' paperwork burden attributable to the Warranty Rule. This estimate includes the task of ensuring that new warranties and changes to existing warranties comply with the Rule. Staff continues to estimate that there are 4,241 manufacturing entities, which results in a burden figure of 33,928 hours (4,241 × 8 hours annually/manufacturer), rounded to 34,000.
In 2001, FTC staff estimated that the information collection burden of including the disclosures required by the Pre-Sale Availability Rule in consumer product warranties was approximately 2,760,000 hours per year. There has been no change in the Rule's paperwork requirements since the previous clearance request in 2001, and the staff has determined, based on its knowledge of the industry, that the number of manufacturers subject to the Rule remains largely unchanged. Staff continues to estimate that there are 6,552 large retailers, 422,100 small retailers, 146 large manufacturers, and 4,095 small manufacturers. Staff estimates that large retailers spend an average of 26 hours per year and small retailers an average of 6 hours per year to comply with the Rule. This yields a total burden of 2,702,952 hours for retailers. Large manufacturers spend an average of 52 hours per year and small manufacturers spend an average of 12 hours per year, for a total burden estimate of 56,732 hours. Thus, the combined total burden is 2,760,000 hours, rounded to the nearest thousand.
Since 2001, some online retailers have begun to post warranty information on their web sites, which should reduce their cost of providing the required information. However, this method of compliance is still evolving and involves a relatively small number of firms. Furthermore, those online retailers that also operate “brick-and-mortar” operations would still have to provide paper copies of the warranty for review by those customers who do not do business online. Thus, online methods of complying with the Rule do not yet appear to be sufficiently widespread so as to significantly alter the measure of burden associated with the Rule, although it is likely to decrease that burden in the future.
Although the Rule's paperwork requirements have not changed since the FTC's immediately preceding PRA clearance request, the audits filed by the IDSMs indicate that fewer disputes were handled in 2002, which reduces the annual hours burden. The calculations underlying these new estimates follow.
The amount of work required will depend on the total number of dispute resolution proceedings undertaken in each IDSM. The 2002 audit report for the BBB AUTO LINE states that, during calendar year 2002, it handled 22,996 warranty disputes on behalf of 14 manufacturers (including General Motors, Saturn, Honda, Volkswagen, Isuzu, and Nissan, as well as smaller companies such as Rolls Royce and Land Rover).
Staff assumes that IDSMs use skilled clerical or technical support staff to compile and maintain the records required by the Rule at an hourly rate of $16; thus, the labor cost associated with the 23,878 recordkeeping burden hours is $382,048. Staff further assumes that IDSMs use clerical support at an hourly rate of $10.75 to reproduce records, and therefore that the labor costs of the 8,955 disclosure burden hours is approximately $96,266. Accordingly, the combined total labor cost for recordkeeping and disclosures is $478,314.
The only additional cost imposed on IDSMs operating under the Rule that would not be incurred for other IDSMs is the annual audit requirement. One of the IDSMs currently operating under the Rule estimates the total annual costs of this requirement to be under $100,000. Because there are three IDSMs operating under the Rule (Toyota, Mitsubishi, and Chrysler share the same IDSM, though each company is reported separately), staff estimates the total non-labor costs associated with the Rule to be three times that amount, or $300,000.
Federal Trade Commission.
Proposed consent agreement.
The consent agreement in this matter settles alleged violations of Federal law prohibiting unfair or deceptive acts or practices or unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the draft complaint that accompanies the consent agreement and the terms of the consent order—embodied in the consent agreement—that would settle these allegations.
Comments must be received on or before August 6, 2004.
Comments should refer to “Gateway Learning Corporation, File No. 042 3047,” to facilitate the organization of comments. A comment filed in paper form should include this reference both in the text and on the envelope, and should be mailed or delivered to the following address: Federal Trade Commission/Office of the Secretary, Room H-159, 600 Pennsylvania Avenue, NW., Washington, DC 20580. Comments containing confidential material must be filed in paper form, as explained in the Supplementary Information section. The FTC is requesting that any comment filed in paper form be sent by courier or overnight service, if possible, because U.S. postal mail in the Washington area and at the Commission is subject to delay due to heightened security precautions. Comments filed in electronic form (except comments containing any confidential material) should be sent to the following e-mail box:
Jessica Rich, FTC, Bureau of Consumer Protection, 600 Pennsylvania Avenue, NW., Washington, DC 20580, (202) 326-3224.
Pursuant to Section 6(f) of the Federal Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46(f), and Section 2.34 of the Commission's Rules of Practice, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC home page (for July 7, 2004), on the World Wide Web, at
Public comments are invited, and may be filed with the Commission in either paper or electronic form. Written comments must be submitted on or before August 6, 2004. Comments should refer to “Gateway Learning Corporation, File No. 042 3047,” to facilitate the organization of comments. A comment filed in paper form should include this reference both in the text and on the envelope, and should be mailed or delivered to the following address: Federal Trade Commission/Office of the Secretary, Room H-159, 600 Pennsylvania Avenue, NW., Washington, DC 20580. If the comment contains any material for which confidential treatment is requested, it must be filed in paper (rather than electronic) form, and the first page of the document must be clearly labeled “Confidential.”
The FTC Act and other laws the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. All timely and responsive public comments, whether filed in paper or electronic form, will be considered by the Commission, and will be available to the public on the FTC Web site, to the extent practicable, at
The Federal Trade Commission has accepted an agreement, subject to final approval, to a proposed consent order from Gateway Learning Corporation (“GLC”). GLC markets and sells products designed for children who are learning math and reading under the “Hooked on Phonics” brand name and trademark.
The proposed consent order has been placed on the public record for thirty (30) days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After thirty (30) days, the Commission will again review the agreement and the comments received and will decide whether it should withdraw from the agreement and take other appropriate action or make final the agreement's proposed order.
This matter concerns alleged misrepresentations about how personal information collected from consumers through the proposed respondent's Web site would be used and alleged unfair practices in connection with proposed respondent's changes to its online privacy policy. The proposed respondent collects personal information from consumers on its Web site, including information from parents who purchase Hooked on Phonics products for their children. Such information includes the parent's first and last name, address, phone number, email address, purchase history, and his or her child's age range and gender. The proposed respondent maintains a privacy policy on its Web site that describes how it handles personal information collected from consumers.
The Commission's complaint charges that the proposed respondent falsely represented that information collected from consumers through its Web site would not be sold, rented, or loaned to third parties and that personal information about children under the age of thirteen would not be provided to any third party for any purpose. In fact, the complaint alleges, proposed respondent rented to third parties information about consumers and the age range and gender of their children. This information was used to send direct mail and make telemarketing calls to consumers.
The complaint also alleges that by posting a revised privacy policy containing material changes to its practices that were inconsistent with its original promise to consumers and retroactively applying such changes to previously-collected information, the proposed respondent engaged in an unfair practice. As alleged in the complaint, the proposed respondent collected personal information under a privacy policy that specifically stated that it did not sell, rent, or loan such information to third parties. It then changed its posted privacy policy to state that it may provide such information to third parties and, without providing any additional notice to consumers, applied this change to information collected under the earlier policy. Thus, without sufficient notice to consumers, the proposed respondent adopted a new policy and practice of sharing information with third parties that directly contradicted the promise made to consumers when the information was collected. The complaint alleges that this retroactive application of proposed respondent's revised privacy policy caused or is likely to cause substantial injury to consumers by subjecting them to unwanted direct mail and telemarketing calls. Further, such injury is not outweighed by countervailing benefits to consumers or competition and is not reasonably avoidable by consumers.
Lastly, the complaint alleges that the proposed respondent misrepresented that it would notify consumers of material changes to its information practices, when in fact, it did not notify consumers of material changes to its information practices. Instead, the proposed respondent posted a revised privacy policy on its Web site without any indication that the policy had materially changed or what aspects of the policy had changed.
Part I of the consent order prohibits the proposed respondent, in connection with the collection of personal information from or about an individual, from misrepresenting (1) That it will not sell, rent, or loan to third parties such personal information; (2) that it will not provide to any third party personal information about children under the age of thirteen; (3) the manner by which it will notify consumers of changes to its privacy policy; or (4) the manner in which it will collect, use, or disclose personal information.
Part II of the order prohibits the proposed respondent from disclosing to any third party any personal information collected on its Web site prior to the date it posted its revised privacy policy permitting third-party sharing (June 20, 2003), unless it obtains the express affirmative (“opt-in”) consent of the consumers to whom such personal information relates. Part III of the order prohibits the proposed respondent, in connection with the posting in the future of any privacy policy that contains a material change from the previous version of the policy, from applying such changes to information collected from or about consumers before the date of the posting, unless it obtains the express affirmative (“opt-in”) consent of the consumers to whom such personal information relates. Part IV of the order requires the proposed respondent to pay $4,608 to the United States Treasury as disgorgement of its profits from renting customer data.
The remainder of the proposed order contains standard requirements that the proposed respondent: maintain copies of privacy statements and other documents relating to the collection, use or disclosure of personally identifiable information and to any efforts to obtain the consent of consumers and documents demonstrating such consent as required by Parts II and III of the order; distribute copies of the order to certain company officials and employees; notify the Commission of any change in the corporation that may affect compliance obligations under the order; and file one or more reports detailing its compliance with the order. Part IX of the proposed order is a provision whereby the order, absent certain circumstances, terminates twenty years from the date of issuance.
The purpose of this analysis is to facilitate public comment on the proposed order, and is not intended to constitute an official interpretation of the agreement and proposed order or to modify in any way its terms.
The proposed order, if issued in final form, will resolve the claims alleged in the complaint against the named respondent. It is not the Commission's intent that acceptance of this consent agreement and issuance of a final decision and order will release any claims against any unnamed persons or entities associated with the conduct described in the complaint.
By direction of the Commission.
Administration on Aging, HHS.
Notice.
The Administration on Aging (AoA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Submit written comments on the collection of information by August 13, 2004.
Submit written comments on the collection of information by fax 202.395.6974 or by mail to the Office of Information and Regulatory Affairs, OMB, New Executive Office Bldg., 725 17th St. NW., Rm. 10235, Washington, DC 20503, Attn: Brenda Aguilar, Desk Officer for AoA.
In compliance with 44 U.S.C. 3507, AoA has submitted the following proposed collection of information to OMB for review and clearance.
The Supplemental form to the Financial Status Report for all AoA Title III Grantees provides an understanding of how projects funded by the Older Americans Act are being administered by grantees, in conformance with legislative requirements, pertinent Federal regulations and other applicable instructions and guidelines issued by Administration on Aging (AoA). This information will be used for Federal oversight of Title III Projects. AoA estimates the burden of this collection of information as follows: 56 State Agencies on Aging respond semiannually which should be an average burden of 1 hour per State agency per submission.
Transmission of HIV and hepatitis in the health care setting can occur through unsafe injections and other unsafe medical practices, including occupational exposure to blood. The persons most at risk of infection through unsafe injections are the injection recipients, health care workers through contaminated needles and syringes, and the wider community through exposure to contaminated sharps waste.
Estimates of the global burden of disease from unsafe injections suggests that, in the year 2000, unsafe injections around the world accounted for five percent of HIV infections, 32 percent of hepatitis B virus infections, 40 percent of hepatitis C virus infections, 28 percent of liver cancers, and 24 percent of cirrhosis cases (World Health Organization (WHO), 2003). While such estimates have limitations, the data suggests that injection overuse and unsafe injection practices contribute towards contaminated, and often unnecessary, injections in the formal and informal health sector, and therefore constituting a significant mode of transmission for HIV and hepatitis. Concern about the negative outcomes of unsafe injections, including transmission of blood-borne pathogens, abscess formation, etc., has focused attention on scaling up interventions to stop the inappropriate and unsafe use of injection equipment.
This announcement provides funding to implement a National Injection Safety Plan in each of the seven countries, and expects demonstrable, measurable results within the first year of the award. An additional intent is to develop sustained indigenous capacity to continue these programs after the project ends.
Measurable outcomes of this program will be in alignment with the following performance goal for President Bush's Emergency Plan for AIDS Relief (PEPFAR): Prevent seven million HIV infections in 15 focus countries heavily afflicted by AIDS.
This initiative is a coordinated effort led by the Office of the Global AIDS Coordinator at the Department of State and involves various U.S. Federal Government agencies including the Department of State, Department of Health and Human Services (HHS), Department of Defense, the U.S. Agency for International Development, and the Peace Corps.
This program is authorized under Sections 301(a) and 307 of the Public Health Service Act [42 U.S.C. Sections 241 (a) and 242l], as amended, and under Public Law 108-25 (United States Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003) [22 U.S.C. 7601].
All applicants should propose and budget for activities in all seven countries. The final determination of country assignment and funding will be determined at the time of award.
This funding announcement is intended to build on work recently performed during the initial rapid implementation of safe-injection activities under PEPFAR. The principal tasks of that rapid implementation phase were as follows:
1. Perform an initial assessment of the current injection practices within each country.
2. Develop a National Injection Safety Plan for the safe and appropriate use of injections.
3. Design and field-test a project to enhance injection safety in selected area(s) of each country that would address improving provider skills, improve procurement and management of safe injection equipment and supplies, increase managers' awareness and skills, and advocate for reducing demand for injections and knowledge about injection safety among the general public.
4. Develop and implement an advocacy strategy for wider public understanding and support for the development of the National Injection Safety Plan.
Measurable outcomes of the program will be in alignment with the priorities of PEPFAR, a five-year initiative to turn the tide in combating the global HIV/AIDS pandemic. The PEPFAR is intended to address the goal of
• Train and educate health care workers in safer medical practices, including safe injection practices, universal precautions, selection of appropriate waste-management options, and decreasing unnecessary medications, particularly injections.
• Develop and/or update institutional service-delivery policies, standards, guidelines, job descriptions, monitoring tools, etc., to reflect management practices in safe injections and in the waste management of sharps waste (in accordance with national or international standards).
• Assist and train health care workers and logisticians in safe-injection commodity forecasting, financing, procurement, logistics, and supply management to ensure that both sterile, single-use injection devices for injection and reconstitution and safety boxes are available in health care facilities in sufficient quantities for the number of injections administered.
• Advise and assist program managers and facility administrators to direct, supervise and monitor activities to improve injection safety within their areas.
• Develop a mechanism to review progress and lessons learned between the National Injection Safety Plan group and personnel from the pilot project.
• Procure appropriate commodities for safe injection practices and ensure that all health care facilities have sufficient quantities of all commodities, including single-use injection equipment, gloves, diluent, soap, and safety boxes, preferably using existing distribution systems, when appropriate.
• Develop and strengthen existing systems for reliable commodity management, including selection, forecasting, procurement, and distribution, of injection equipment matched with needs for injectable medications and safety boxes in sufficient quantities for the number of injections administered.
• Ensure “bundling” of injectable vaccines, injectable contraceptives, and tuberculosis medicines in donor-supported programs with single-use needles and syringes that include reuse-prevention features and safety boxes.
• To decrease unnecessary injections, ensure oral formulations of commonly used medications are available at the health facilities. This might require revision of the essential drug list.
• Ensure inclusion of injection equipment on essential drug lists on a facility and/or national level.
• Using each country's National Injection Safety Plan, the awardee(s) will attempt to increase public support for injection safety among the main target audiences, which include: program managers, health facility administrators, professional associations, health workers, pharmacies, training institutions including medical schools, and the general public.
• The awardee will work with non-governmental organizations NGOs to integrate community-based activities to decrease the use of unsafe injections and increase knowledge of injection safety.
• Develop and strengthen systems to support proper disposal of sharps at the level of this intervention. (The awardee would not directly support capital costs for waste management. The awardee's role would be limited to technical assistance in assessment, planning and leveraging support from other external agencies for items such as incinerators.) This should be done in accordance with national policies for safe management of health care waste, if such a policy exists. If such a policy does not exist, these activities should be done in accordance with international standards (
• Forecast and provide sufficient quantities of puncture-proof sharps containers (
HHS/CDC activities for this program are as follows:
• Provide scientific and technical assistance in refining the operational plan.
• Provide ongoing technical assistance in addressing problems encountered in implementing your plan.
• Assist in assessing program operations and in evaluating overall effectiveness of your program.
• Staff in both headquarters (HHS/CDC Atlanta, HHS/CDC in country, and the HHS Office of Global Health Affairs in Washington) and in the designated countries will assure that other related U.S. Government (USG) activities are well coordinated with national programs in each country.
Throughout the project period, HHS/CDC's commitment to continuation of awards will be conditioned on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the Federal Government.
Applications may be submitted by public and private non-profit and for-profit organizations may submit applications, such as:
• Public non-profit organizations;
• Private non-profit organizations;
• For-profit organizations;
• Universities; and
• Faith-based organizations.
Matching funds are not required for this program.
If you request a funding amount greater than the ceiling of the award range, your application will be considered non-responsive and will not be entered into the review process. You will be notified that your application did not meet the submission requirements.
If your application is incomplete or non-responsive to the requirements listed in this section, it will not be entered into the review process. You will be notified that your application did not meet submission requirements.
Title 2 of the United States Code Section 1611 states that an organization described in Section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, or loan.
To apply for this funding opportunity use application form PHS 5161. Application forms and instructions are available on the HHS/CDC Web site, at the following Internet address:
If you do not have access to the Internet, or if you have difficulty accessing the forms on-line, you may contact the HHS/CDC Procurement and Grants Office Technical Information Management Section (PGO-TIM) staff at: 770-488-2700. Application forms can be mailed to you.
• Maximum number of pages: 30 (Note: Appendices and budget narrative are not included in the page total). If your narrative exceeds the page limit, only the first pages, which are within the page limit, will be reviewed.
• Font size: 12-point unreduced
• Double-spaced
• Paper size: 8.5 by 11 inches
• Page margin size: One inch
• Printed only on one side of page
• Held together only by rubber bands or metal clips; not bound in any other way.
Your narrative proposal should address activities to be conducted over the entire project period. Proposals should detail the implementation of the methodologies put forward in the program description, showing the phasing or dates by which planned activities would be carried out. The implementation plan shall include the following:
• Description of the need for National Injection Safety Plans in the seven countries and the anticipated outcome on HIV prevention.
• Description of the rationale and technical approach for expanding the use of proven best practices in injection safety in the following countries: Botswana, Côte d'Ivoire, Haiti, Kenya, Rwanda, South Africa, and Tanzania.
• Description of all planned activities in the first 12 months, including:
a. Sequence of tasks and location for intervention.
b. Timeframes for implementing each activity.
c. Involvement of alliances/partners/twinning.
d. Procurement and distribution plan, including estimated equipment needs and plans for use of existing country mechanisms.
e. Sustainability plan.
• Management Plan
a. Proposed lines of responsibility, authority, and communication through which tasks will be managed.
b. Procedure to ensure quality control and cost control.
• Organizational Structure and Staffing Plan, including:
a. Key personnel plan.
b. Other long and short-term staff required for implementing each activity.
c. Demonstrated capabilities, specific local experiences, education, and qualifications for each member of the key personnel plan.
d. List of alternates for key personnel plan.
e. Subcontractor staffing plans.
f. Plan for proposed project team to interface with the applicant's corporate structure, possible sub-contractors, and HHS/CDC's management structure.
• Monitoring and Evaluation Plan, showing how:
a. Outcomes will be measured.
b. Outcomes will contribute to results.
• The applicants shall provide information regarding their past experience in working with other organizations on similar types of projects.
Applicants may include additional information in the application appendices. The appendices will not be counted toward the narrative page limit. This additional information includes the following:
• Curriculum Vitas or Resumes;
• Organizational Charts; and
• Letters of Support, etc.
You are required to have a Dun and Bradstreet Data Universal Numbering System (DUNS) number to apply for a grant or cooperative agreement from the Federal government. The DUNS number is a nine-digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, access
For more information, see the HHS/CDC Web site at:
If your application form does not have a DUNS number field, please write your DUNS number at the top of the first page of your application, and/or include your DUNS number in your application cover letter.
Additional requirements that may require you to submit additional documentation with your application are listed in section “VI.2. Administrative and National Policy Requirements.”
This announcement is the definitive guide on application submission address and deadline. It supersedes
HHS/CDC will not notify you upon receipt of your application. If you have a question about the receipt of your application, first contact your courier. If you still have a question, contact the PGO-TIM staff at: 770-488-2700. Before calling, please wait two to three days after the application deadline. This will allow time for applications to be processed and logged.
Executive Order 12372 does not apply to this program.
Restrictions, which must be taken into account while writing your budget, are as follows:
• Funds may be used only for activities associated with decreasing unsafe injections.
• Funds may be spent for reasonable program purposes, including personnel, travel, supplies, and services. Equipment may be purchased if deemed necessary to accomplish program objectives; however, prior approval by HHS/CDC officials must be requested in writing.
• All requests for funds contained in the budget shall be stated in U.S. dollars. Once an award is made, HHS/CDC will not compensate foreign grantees for currency exchange fluctuations through the issuance of supplemental awards.
• The costs that are generally allowable in grants to domestic organizations are allowable to foreign institutions and international organizations, with the following exception: With the exception of the American University, Beirut, and the World Health Organization, Indirect Costs will not be paid (either directly or through sub-award) to organizations located outside the territorial limits of the United States or to international organizations regardless of their location.
• The applicant may contract with other organizations under this program; however, the applicant must perform a substantial portion of the activities (including program management and operations, and delivery of prevention services for which funds are required).
• You must obtain an annual audit of these HHS/CDC funds (program-specific audit) by a U.S.-based audit firm with international branches and current licensure/authority in-country, and in accordance with International Accounting Standards or equivalent standard(s) approved in writing by HHS/CDC.
• A fiscal Recipient Capability Assessment may be required, prior to or post award, in order to review the applicant's business management and fiscal capabilities regarding the handling of U.S. Federal funds.
• U.S. Government funds may be used for direct costs such as salaries; necessary travel; operating costs, including supplies, fuel, utilities, etc.; staff training costs, including registration fees and purchase and rental of training related equipment; and purchase of HIV-testing reagents, test kits, and laboratory equipment for HIV testing.
• No funds appropriated under this solicitation shall be used to carry out any program of distributing sterile needles or syringes for the hypodermic use of any illegal drug.
• In accordance with 45 CFR Part 74.81, no HHS funds may be paid as profit to any recipient, even if the recipient is a commercial organization. Profit is any amount in excess of allowable direct and indirect costs.
The U.S. Government is opposed to prostitution and related activities, which are inherently harmful and dehumanizing, and contribute to the phenomenon of trafficking in persons. Any entity that receives, directly or indirectly, U.S. Government funds in connection with this document (“recipient”) cannot use such U.S. Government funds to promote or advocate the legalization or practice of prostitution or sex trafficking. Nothing in the preceding sentence shall be construed to preclude the provision to individuals of palliative care, treatment, or post-exposure pharmaceutical prophylaxis, and necessary pharmaceuticals and commodities, including test kits, condoms, and, when proven effective, microbicides. A recipient that is otherwise eligible to receive funds in connection with this document to prevent, treat, or monitor HIV/AIDS shall not be required to endorse or utilize a multisectoral approach to combating HIV/AIDS, or to endorse, utilize, or participate in a prevention method or treatment program to which the recipient has a religious or moral objection. Any information provided by recipients about the use of condoms as part of projects or activities that are funded in connection with this document shall be medically accurate and shall include the public health benefits and failure rates of such use.
In addition, any foreign recipient must have a policy explicitly opposing, in its activities outside the United States, prostitution and sex trafficking, except that this requirement shall not apply to the Global Fund to Fight AIDS, Tuberculosis and Malaria, the World Health Organization, the International AIDS Vaccine Initiative or to any United Nations agency, if such entity is a recipient of U.S. Government funds in connection with this document.
The following definitions apply for purposes of this clause:
• “Sex trafficking” means the recruitment, harboring, transportation, provision, or obtaining of a person for the purpose of a commercial sex act. 22 U.S.C. 7102(9).
• A “foreign recipient” includes an entity that is not organized under the laws of any State of the United States, the District of Columbia, or the Commonwealth of Puerto Rico. Restoration of the Mexico City Policy, 66 FR 17303, 17303 (March 28, 2001).
All recipients must insert provisions implementing the applicable parts of this section, “Prostitution and Related Activities,” in all subagreements under this award. These provisions must be express terms and conditions of the subagreement, acknowledge that each certification to compliance with this section, “Prostitution and Related Activities,” are a prerequisite to receipt of U.S. government funds in connection with this document, and must acknowledge that any violation of the provisions shall be grounds for unilateral termination of the agreement prior to the end of its term. In addition, all recipients must ensure, through contract, certification, audit, and/or any other necessary means, all the applicable requirements in this section, “Prostitution and Related Activities,” are met by any other entities receiving U.S. government funds from the recipient in connection with this document, including without limitation, the recipients' sub-grantees, sub-contractors, parents, subsidiaries, and affiliates. Recipients must agree that HHS may, at any reasonable time, inspect the documents and materials maintained or prepared by the recipient in the usual course of its operations that relate to the organization's compliance with this section, “Prostitution and Related Activities.”
All primary grantees that receive U.S. Government funds in connection with this document must certify compliance prior to actual receipt of such funds in a written statement referencing this document (
Recipients' compliance with this section, “Prostitution and Related Activities,” is an express term and condition of receiving U.S. Government funds in connection with this document, and any violation of it shall be grounds for unilateral termination by HHS of the agreement with HHS in connection with this document prior to the end of its term. The recipient shall refund to HHS the entire amount furnished in connection with this document in the event it is determined by HHS that the recipient has not complied with this section, “Prostitution and Related Activities.”
Guidance for completing your budget can be found on the HHS/CDC Web site, at the following Internet address:
Applicants should budget for activities in all seven countries. The final determination of funding and country assignment will be determined at the time of award.
Applications may not be submitted electronically at this time.
You are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the cooperative agreement. Measures of effectiveness must relate to the performance goals stated in the “Purpose” section of this announcement. Measures must be objective and quantitative, and must measure the intended outcome. These measures of effectiveness must be submitted with the application and will be an element of evaluation.
Your application will be evaluated against the following criteria:
a. Experience in the area of safe injections (15 points)—Does the applicant and each of its partnering organizations have experience working in the area of medical injection safety in developing countries?
b. Experience in the area of infection-control practices (15 points)—Does the applicant and each of its partnering organizations have experience working in the area of infection control practices in developing countries?
c. Staffing and management (15 points)—Is the size of the organization adequate for the project? Is the current staffing and management capacity of the applicant adequate for the project?
a. Technical approach (6 points)—Is the technical approach sound and reasonable?
b. Staffing and management (8 points)—Is the proposed staffing and management plan reasonable?
c. Equipment and supplies management and distribution (8 points)—Does the applicant have a sound and reasonable plan for managing and distributing safe injectable materials and supplies?
d. Training (6 points)—Does the applicant have the resources and a reasonable plan to develop a comprehensive training program in the reduction of unsafe medical injections and in infection control practices?
e. Monitoring and evaluation (6 points)—Is the monitoring and evaluation plan feasible? Does the plan measure important indicators?
f. Sustainability (6 points)—Is the plan for sustainability reasonable and feasible?
Are the measures of effectiveness reasonable?
Is there a plan or strategy for effectively collaborating with the Ministries of Health and local health-care providers?
The Procurement and Grants Office (PGO) staff will review your application for completeness, and the HHS/CDC National Center for HIV, STD and TB Prevention (NCHSTP) will review it for responsiveness. Incomplete applications and applications that are non-responsive to the eligibility criteria will not advance through the review process. Applicants will be notified that their application did not meet submission requirements.
An objective review panel will evaluate complete and responsive applications according to the criteria listed in the “V.1. Criteria” section above.
In addition, the following factors may affect the funding decision:
• Geographic distribution and population of all seven countries—to ensure that funding is not concentrated in any one catchment area.
• Percentage of staff who are citizens of the country in which services will be provided.
• No award will be made without the concurrence of the U.S. Embassy and the CDC representative in the country under consideration.
September 1, 2004.
Successful applicants will receive a Notice of Grant Award (NGA) from the HHS/CDC Procurement and Grants Office. The NGA shall be the only binding, authorizing document between the recipient and HHS/CDC. The NGA will be signed by an authorized Grants Management Officer, and mailed to the recipient fiscal officer identified in the application.
Unsuccessful applicants will receive notification of the results of the application review by mail.
For more information on the Code of Federal Regulations, see the National Archives and Records Administration at the following Internet address:
The following additional requirements apply to this project:
• AR-4 HIV/AIDS Confidentiality Provisions
• AR-5 HIV Program Review Panel Requirements
• AR-6 Patient Care
• AR-9 Paperwork Reduction Act Requirements
• AR-10 Smoke-Free Workplace Requirements
• AR-12 Lobbying Restrictions
• AR-15 Proof of Non-Profit Status
• AR-16 Security Clearance Requirement
• AR-23 States and Faith-Based Organizations
Additional information on these requirements can be found on the HHS/CDC Web site at the following Internet address:
You must provide HHS/CDC with an original, plus two copies of the following reports:
1. Interim progress report, no less than 90 days before the end of the budget period. The progress report will serve as your non-competing continuation application, and must contain the following elements:
a. Current Budget Period Activities Objectives.
b. Current Budget Period Financial Progress.
c. New Budget Period Program Proposed Activity Objectives.
d. Detailed Line-Item Budget and Justification.
e. Additional Requested Information.
f. Measures of Effectiveness.
2. Semi-annual progress report, due seven months after the beginning of each budget period. This report should contain the following elements:
a. Progress on Achieving Objectives.
b. Modification or New Activities.
3. Financial status report, no more than 90 days after the end of the budget period.
4. Final financial and performance reports, no more than 90 days after the end of the project period.
These reports must be sent to the Grants Management Specialist listed in the “Agency Contacts” section of this announcement.
For general questions about this announcement, contact:
Technical Information Management Section, HHS/CDC Procurement and Grants Office, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770-488-2700.
For program technical assistance, contact:
Kenneth Clark, M.D., MPH, Project Officer, National Center for HIV, STD, and TB Prevention, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, 1600 Clifton Road, NE, MS E04, Atlanta, GA 30333, Telephone: 404-639-8057, E-mail:
For budget assistance, contact:
Diane Flournoy, Contract Specialist, HHS/CDC Procurement and Grants Office, U.S. Department of Health and Human Services, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770-488-2072, E-mail:
A notice announcing the availability of fiscal year (FY) 2004 funds for a cooperative agreement entitled, “Demonstration Projects for Implementation of Rapid HIV Testing in Historically Black Colleges and Universities and Alternative Venues and Populations” was published in the
On page 35035, column three, the Purpose section, please note: Part 1 of this funding opportunity serves only attendees of Historically Black Colleges and Universities (HBCUs), not Hispanic Serving Institutions.
On page 35036, column three, under “Award Information,” please:
Change the project period from 12 months to two years.
A notice announcing the availability of fiscal year (FY) 2004 funds for a cooperative agreement entitled, “Morbidity and Risk Behavior Surveillance” was published in the
On page 35371, column one, section “III. Eligible Applicants,” please change the first sentence to read: Eligible applicants are limited to those state, local, or territorial health departments randomly sampled by the RAND Corporation in a national probability sample.
On page 35371, column three, section “IV.2. Content and Form of Submission,” please change narrative plan requirements to read: Your narrative plan should address activities to be conducted over the entire project period, and should include the following items in the order listed: Plan, Methods, Objectives, Timeline, Staff, Understanding of Need, Performance Measures, Budget and Justification. Or the applicant can choose to describe activities using these items: Methods, Capacity, Objectives, Proposed Data Uses, and Budget and Justification. In either case, the budget justification will not be counted in the stated page limit.
This program is authorized under Section 317(k) of the Public Health Service Act [42 U.S.C. Section 247b(k)], as amended.
This program addresses the “Healthy People 2010” focus area(s) of HIV. Measurable outcomes of the program will be in alignment with one (or more) of the following performance goal(s) for the National Center for HIV, STD, and TB Prevention (NCHSTP): Strengthen the capacity nationwide to monitor the epidemic; develop and implement effective HIV prevention interventions and evaluate prevention programs; and to also decrease the number of persons at high risk for acquiring or transmitting HIV infection.
For the purpose of this program announcement, an innovative HIV behavioral intervention is an intervention to reduce HIV risk behavior(s) that uses an approach or method that is different from interventions used by other organizations that serve the target populations addressed by this announcement. The intervention must also have been developed from the “ground up,” that is, in close collaboration with the community or communities served by the CBO. The innovative approach or method can include an expansion or modification of existing behavioral theories that results in novel intervention strategies or activities and addresses behavior change at either the social, structural, or individual levels.
An intervention that has a published outcome evaluation, or that has demonstrated statistically significant positive intervention effects on HIV-related behavioral or biologic outcomes using a rigorous outcome evaluation, and therefore meets the criteria for inclusion in the Compendium of HIV Prevention Interventions with Evidence of Effectiveness (
An existing innovative HIV behavioral intervention is an intervention that has well-defined and documented procedures and protocols that is currently being delivered to high-risk, minority individuals.
The CBO must provide evidence from its program operations suggesting that the intervention has the potential for reducing HIV risk behaviors. This evidence can be based on outcome data (
Furthermore, the innovative HIV behavioral intervention MUST NOT have undergone a rigorous outcome evaluation. A rigorous outcome evaluation is one that measures the short- or long-term effects of the intervention as delivered to one group in comparison to a group that has not received the intervention.
Any minority population at risk for HIV can be studied as part of this announcement. Proposals that seek to evaluate interventions designed for minority HIV seropositive people or interventions designed for minority populations not well-represented among those listed in the Compendium of HIV Prevention Interventions with Evidence of Effectiveness (examples include but are not limited to men who have sex with men, migrants, commercial sex workers, and transgendered) are especially welcome.
If CDC funds your CBO, you will be responsible for the following activities:
1. Secure adequate funding for implementation of the existing innovative intervention from sources other than this program announcement during the two-year evaluation period.
2. Provide CDC personnel with your existing intervention protocol, including all manuals, procedures, and other relevant materials.
3. In collaboration with CDC, establish a plan to evaluate your innovative intervention. The evaluation plan must include one pre-intervention baseline assessment, at least one follow-up assessment delivered at a minimum of 6 months after completion of the intervention, and the inclusion of a comparison group.
4. Develop measures and related data collection instruments to evaluate the effects of the innovative intervention. New instruments need to be field-tested.
5. Develop procedures to ensure confidentiality and informed consent, when appropriate, and obtain any other approvals as needed.
6. Recruit participants for the intervention and comparison groups.
7. Conduct individual baseline and follow-up assessment(s) according to the evaluation design.
8. Monitor intervention activities for quality assurance such that the intervention delivery is consistent with the established protocol.
9. Establish data management systems, analyze and interpret the data.
10. Prepare a final report for CDC, including submission of a cleaned data set.
11. Develop and implement a plan for using the evaluation results to improve implementation of the existing intervention by the CBO.
12. Develop and implement a plan to disseminate the findings and outcomes of the evaluation, including recommendations for the implementation of the successful innovative HIV behavioral intervention, presentations at state-wide and national health professional meetings, and reports of findings and recommendations.
13. If the innovative HIV behavioral intervention is found not to be successful, conduct a thorough examination of process evaluation data to explain the lack of success; that is, to identify potential problems or barriers in achieving HIV risk reduction.
In a cooperative agreement, CDC staff will be substantially involved in the program activities, above and beyond routine grant monitoring. CDC Activities for this program are as follows:
1. Provide oversight to the cooperative agreement recipients in developing evaluation and data collection materials.
2. Provide assistance and consultation to assist the recipient in planning and implementing the evaluation, including technical guidance in the development of the evaluation design, data collection instruments, selection of comparison groups, outcome measures, data collection protocols, and pretesting of methods and instruments.
3. Ensure that the results of successful innovative HIV behavioral interventions and lessons learned from the evaluation are shared among grantees through meetings, workshops, conferences, newsletters, and other avenues of communication (
4. Ensure that the results of the evaluation are used to improve the existing intervention by the CBO.
5. Monitor successes and difficulties in the implementation and evaluation of the innovative intervention.
6. Monitor the protection of client privacy and compliance with other local, state and Federal requirements.
7. Monitor the award recipients' quality assurance activities and progress toward achieving target levels of performance for each core activity.
8. Collaborate and provide guidance in data analysis and dissemination of findings.
CDC involvement in this program is listed in the Activities Section above.
Throughout the project period, CDC's commitment to continuation of awards will be conditioned on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the Federal Government.
Applications may only be submitted by eligible CBOs, including faith-based CBOs, that provide HIV prevention services to members of racial/ethnic minority communities at high risk for HIV infection.
To be eligible, your CBO must meet all of the criteria listed below. Your CBO must:
A. Have tax-exempt status.
B. Be located in the area(s) where services will be provided or have provided services in the area for at least three years.
C. Not be a government or municipal agency, private or public university or college, or private hospital.
D. Not be a 501(c)(4) organization.
E. Your CBO must provide proof of very significant experience in delivering HIV prevention services to the targeted racial/ethnic minority populations during each of the last three years, and that the CBO has provided HIV prevention services to at least 200 clients in your proposed high-risk population during each of the last three years.
F. Your CBO must provide reasonable proof of adequate funding for the intervention during the next two years of this evaluation. If the funding is from the Federal Government, then the reasonable proof can be a copy of the latest Notice of Grant Award. Reasonable proof from other funding sources can include a letter from the funding agency indicating that funding will be available for the two years during which the intervention will be evaluated. If your agency funds the intervention, then reasonable proof can be a letter from the Board of Directors stating that the agency has the financial resources to fund the intervention and intends to fund the intervention for the next two years.
All information submitted with your application is subject to verification during pre-decisional site visits.
Matching funds are not required for this program.
If you request a funding amount greater than the ceiling of the award range, your application will be considered non-responsive, and will not be entered into the review process. You will be notified that your application did not meet the submission requirements.
If your application is incomplete or non-responsive to the requirements listed in this section, it will not be entered into the review process. You will be notified that your application did not meet submission requirements.
Title 2 of the United States Code Section 1611 states that an organization described in Section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, or loan.
To apply for this funding opportunity use application form PHS 5161. Application forms and instructions are available on the CDC Web site, at the following Internet address:
If you do not have access to the Internet, or if you have difficulty accessing the forms on-line, you may contact the CDC Procurement and Grants Office Technical Information Management Section (PGO-TIM) staff at: 770-488-2700. Application forms can be mailed to you.
• Maximum number of pages: 1
• Font size: 12-point unreduced
• Double spaced
• Paper size: 8.5 by 11 inches
• Page margin size: One inch
• Printed only on one side of page
• Written in plain language, avoid jargon
• Maximum number of pages: 25 (not including budget justification and appendices). If your narrative exceeds the page limit, only the first pages which are within the page limit will be reviewed.
• Double spaced
• Font size: 12 point unreduced
• Paper size: 8.5 by 11 inches
• Page margin size: One inch
• Printed only on one side of page
• Written in plain language, avoid jargon
• Held together only by rubber bands or metal clips; not stapled or bound in any other way
• MS WORD format
• Cover Page—the program announcement number and title
• Table of contents—with the major sections and page numbering including each attachment
• Consecutive page numbering throughout the document, including the attachments beginning with the first page of text, number all pages clearly and sequentially, including each page in the appendices.
This section of the program announcement defines program requirements. You must describe your plans to address each requirement. Please answer each item with complete sentences, provide all requested documents, and include Appendices as needed. If you fail to provide the required documents, your application will not be considered for review.
Your narrative should address activities to be conducted over the entire project period, and must include the following items in the order listed:
This section will not count toward the page limit of your application, but it will determine if you are eligible for funding.
Place all documents requested in this section in an Appendix and label
1. Tax-exempt status organizations are eligible. To demonstrate your eligibility, attach a copy of the letter from the Internal Revenue Service (IRS) showing that your CBO is a valid IRS 501(c)(3) tax-exempt non-profit organization, or attach a copy of your state proof of incorporation as a non-profit organization.
2. Government, municipal agency, university/college, or private hospitals are not eligible. To demonstrate your eligibility, provide a statement that your CBO is not a governmental or municipal agency, a government-affiliated organization or agency (
3. IRS 501(c)(4) organizations are not eligible. To demonstrate your eligibility, provide a statement that your CBO is not included in the category described in section 501(c)(4) of the Internal Revenue Code of 1986 that engages in lobbying activities.
4. Location in area or provision of services in area is required. To demonstrate your eligibility, describe your location relative to the served area and describe the duration and type of services provided. Or, describe how your CBO has provided services in the proposed service area for at least three years.
5. CBOs serving ethnic minority populations are eligible. Provide proof that your CBO has very significant experience in delivering HIV prevention services to the targeted racial/ethnic minority populations during each of the last three years.
6. CBOs serving at least 200 minority clients per year are eligible. Provide proof that your CBO has provided HIV prevention services in each of the last three years to at least 200 clients in the proposed high-risk minority population.
7. Adequate funding for existing innovative intervention is required. Provide reasonable proof that your CBO has adequate funding to support the intervention for the two-year duration of this evaluation. If the funding is from the Federal Government, then reasonable proof can be a copy of your latest Notice of Grant Award. Reasonable proof from other funding sources can include a letter from the funding agency indicating that funding will be available for the two years during which the intervention will be evaluated. If your agency funds the intervention, then reasonable proof can be a letter from the Board of Directors stating that the agency has the financial resources to fund the intervention and intends to fund the intervention for the next two years.
Describe the objectives of the proposed program.
1. Describe the components of the innovative intervention. Explain why this HIV behavioral intervention is innovative, and provide an explicit and detailed description of all intervention activities. Emphasize novel intervention strategies or approaches, including the uniqueness and relevance of the approach to HIV risk reduction.
2. Describe how the innovative HIV behavioral intervention was developed from the “ground up;” that is, in collaboration with the community or communities that are served by the intervention. Describe the rationale for developing the intervention, which could include a community-based needs assessment or theoretical basis. Specify the involvement of the target population in planning and implementing the intervention.
3. Provide evidence that the innovative intervention has worked in the past. This evidence can include data from pre- and post-intervention monitoring of outcomes such as behavioral, psychosocial, or biologic data, or process data that can be directly attributable to the innovative intervention.
4. Explain why you think your CBO's innovative intervention works. This explanation can refer to (a) how specific activities, processes or steps led to the observed results, and/or (b) how the intervention was based or expanded upon current behavior change theories.
Contact your health department to obtain HIV/AIDS statistics and HIV needs assessment data developed for the community planning process. This information will help you answer the questions in this section.
1. Describe the ethnic/racial minority target population being served by the innovative intervention. Applicants must include a table in their application as Appendix B that describes the target population. The table must include the following six categories, and provide the numbers (n) and percentages (%) for each subgroup you have served over the past year:
(1) Total sample population;
(2) Transmission risk including MSM, IDU, MSM/IDU, Heterosexual, Other risk group(s);
(3) Gender including Men, Women, Transgender (total), Transgender (male to female), Transgender (female to male);
(4) Age group including < 20, 20 to 29, 30 to 49, 50+;
(5) HIV sero-status including HIV positive, HIV negative, HIV unknown;
(6) Race/Ethnicity including American Indian/Alaskan Native, Asian/Pacific Islander, Black not Hispanic, White not Hispanic, Hispanic, and Unknown or multiple race.
Proposals that seek to evaluate interventions designed for minority HIV seropositive people or interventions designed for minority populations not well-represented among interventions listed in the
2. Describe how the proposed minority target population reflects HIV community planning priorities. Describe how the local, regional or state HIV prevention community plan, especially the epidemiologic profile and behavioral data, were used in the selection of the target population.
3. Provide proof that your CBO has very significant experience in delivering HIV prevention services to the targeted racial/ethnic minority population. Include a history of your CBO's service to the population: Explain how long you have provided services to the population, the kinds of services that have been provided, the outcomes of services provided, and your relationship with the community.
Describe the proposed evaluation plan (including the evaluation question(s), design, methods for recruitment and retention, outcome measures, data analysis plan, dissemination activities, and timeline) to demonstrate the soundness and capability of producing intended results.
1. State the evaluation question(s).
2. Describe the design to be used to evaluate the effects of the intervention. The evaluation design must meet the following criteria:
a. A design including a minimum of one pre-intervention and one post-
b. A design that employs a rigorous evaluation of the effects of the intervention is required. A rigorous evaluation can be accomplished by including a comparison group that does not receive the innovative intervention. Comparison groups can be either concurrent or historical. Examples of concurrent comparisons include (1) your CBO administering the innovative intervention to one segment of the minority target population and not to another during the same period of time, and (2) comparison of data from your CBO's use of the innovative intervention to that of another CBO not using the innovative intervention for the same minority target population. An example of a historical comparison includes comparing outcome data from your CBO's current use of the innovative intervention with data collected at multiple times from the same target population before the implementation of the innovative intervention.
3. Describe how you will recruit participants. A minimum of 200 people from the target population must complete the pre-intervention interview and enroll in the intervention evaluation within one year. That is to say, a minimum of 100 people must be included in the group that receives the intervention, and a minimum of 100 people must be included in the group that does not receive the intervention. Provide proof that your CBO has provided HIV prevention services in each of the last three years to at least 200 clients in the proposed high-risk minority population.
4. Describe how your CBO will retain at least 75 percent of the evaluation cohort for the 6-month follow-up.
5. Specify the HIV risk reduction outcome measures that will be assessed to determine the intervention's effects. Outcomes shall include HIV-related risk behaviors (
6. Provide a plan for data management systems, particularly how your CBO will maintain data quality control, and perform statistical analyses of the outcome data.
7. Describe how your CBO intends to use the results of this evaluation to improve program capacity and enhance delivery of prevention services in the future. In other words, describe in detail how your CBO will use the findings from this evaluation to improve specific HIV program service components offered by your CBO.
8. Describe how you will disseminate the findings and outcomes of evaluation, including recommendations for the implementation of the successful innovative HIV behavioral intervention, through presentations at state-wide and national health professional meetings, and reports of findings and recommendations.
9. Provide a detailed 2-year timeline for the proposed evaluation.
10. Describe, if applicable, how you plan to address confidentiality and any other ethical issues related to the implementation of the evaluation.
1. Describe how your CBO has the technical and programmatic capacity and proven track record to implement and evaluate the intervention in the community. In Appendix C, provide the curriculum vitae or resumes of all key CBO personnel and organizational charts of your CBO.
2. Provide evidence that your CBO has been successful in retaining intervention participants in the past, and can recruit and enroll at least 200 people for the evaluation within one year.
3. If your CBO requires assistance with the design and implementation of the evaluation and the maintenance of quality control during the course of the evaluation, provide a statement of partnerships with locally-based evaluation specialists, evaluation organizations, universities, or health departments. Also provide, if applicable, in Appendix D the curriculum vitae of key personnel of partner organizations and Letters of Support regarding the willingness of partners to collaborate with the CBO and CDC.
4. Provide a plan for CBO and, if applicable, partner staffing and training, as needed, to ensure that the intervention can be properly implemented and evaluated. Provide the qualifications of proposed staff needed to conduct activities, and the percentage of time each staff member will be assigned to the project. If CBO staff will be used to perform the outcome evaluation, then specify how the roles of intervention staff and evaluation staff will be kept distinct and separate to ensure objectivity.
Provide a detailed, line-item budget for year one of the project and a justification for each line-item. This section will not count toward the page limit of your application.
Additional information may be included in the application Appendices. The Appendices will not be counted toward the narrative page limit, and must include the following additional information:
• Appendix A: Proof of Eligibility
• Appendix B: Attachment 1 table with target population characteristics
• Appendix C: Curriculum vitae or resumes of key CBO staff and organizational charts
• Appendix D: Letters of Support and curriculum vitae from partner organizations, if applicable Letters of Support (LOS): If the CBO chooses to partner with another organization or institution that will play a role in conducting intervention activities, then applications must include Letters of Support (LOS) in Appendix D. Each LOS should include a description of the past relationship with the applicant and the role(s) the local partner will play in conducting intervention activities (
• Maximum number of pages: 1
• Font size: 12-point unreduced
• Double spaced
• Paper size: 8.5 by 11 inches
• Page margin size: One inch
• Printed only on one side of page
• Written in plain language, avoid jargon
You are required to have a Dun and Bradstreet Data Universal Numbering System (DUNS) number to apply for a grant or cooperative agreement from the Federal government. The DUNS number is a nine-digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, access
For more information, see the CDC Web site at:
Additional requirements that may require you to submit additional
This announcement is the definitive guide on application submission address and deadline. It supersedes information provided in the application instructions. If your application does not meet the deadline above, it will not be eligible for review, and will be discarded. You will be notified that your application did not meet the submission requirements.
CDC will not notify you upon receipt of your application. If you have a question about the receipt of your application, first contact your courier. If you still have a question, contact the PGO-TIM staff at: 770-488-2700. Before calling, please wait two to three days after the application deadline. This will allow time for applications to be processed and logged.
Executive Order 12372 does not apply to this program.
Restrictions, which must be taken into account while writing your budget, are as follows:
• Funds may be used to hire contractors or support partners to assist with the evaluation. CDC encourages you to develop partnerships with other prevention providers, locally-based researchers, research groups, universities or health departments to evaluate your innovative intervention. However, your CBO, not the contract organization(s) or the partner(s), must conduct the largest portion of the evaluation activities funded by this award.
• Eighty percent (80%) of the funds awarded under subcontracts must be applied directly to the evaluation activities.
• Funds cannot be used to provide medical or substance abuse treatment.
If you are requesting indirect costs in your budget, you must include a copy of your indirect cost rate agreement in an Appendix. If your indirect cost rate is a provisional rate, the agreement should be less than 12 months of age.
Awards will not allow reimbursement of pre-award costs.
Guidance for completing your budget can be found on the CDC web site, at the following Internet address:
Applications may not be submitted electronically at this time.
You are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the cooperative agreement. Measures of effectiveness must relate to the performance goals stated in the “Purpose” section of this announcement. Measures must be objective and quantitative, and must measure the intended outcome. These measures of effectiveness must be submitted with the application and will be an element of evaluation.
Your application will be evaluated against the following criteria:
1. Rate the evaluation question(s) based on their soundness and relevance to HIV behavioral prevention. (3 points)
2. Does the evaluation design include at a minimum one pre-intervention and one post-intervention assessment? Does the post-intervention assessment (
3. Has the applicant proposed an adequate plan to recruit and enroll at least 200 participants within one year of the project? Did the applicant provide adequate proof that their CBO has provided HIV prevention services in each of the last three years to at least 200 clients in the proposed high-risk minority population? (5 points)
4. Has the applicant proposed an adequate plan to retain at least 75 percent of the evaluation cohort for the 6-month follow-up? (5 points)
5. Rate the relevance of the proposed outcome measures that will be used to determine the intervention's effects with respect to HIV risk reduction. Outcomes should assess HIV-related risk behaviors (
6. Are plans for data management systems, data quality control, and statistical analysis of outcome data sufficient and appropriate for assessing the effects of the intervention on HIV risk reduction? (2.5 points)
7. Has the applicant described how the results of this evaluation will be used to improve program capacity and to enhance the delivery of prevention services? In other words, does the applicant describe how the CBO will feed the information gathered from this evaluation back into the program? (2.5 points)
8. Has the CBO provided an adequate plan for the dissemination of results and recommendations from the evaluation? (2.5 points)
9. Is the proposed timeline detailed and is it sufficient to achieve project goals within 2 years? (2.5 points)
10. Has the CBO provided an adequate plan, if applicable, for addressing confidentiality and any other ethical issues related to the implementation of the evaluation? (not scored)
1. Does the applicant provide a thorough description of the components of the intervention and explain why the intervention is innovative (that is, based on a different intervention approach or method)? Rate the innovativeness of the HIV behavioral intervention. The rating should be based on a description of the novel intervention strategies or approaches, including the uniqueness and relevance to HIV risk reduction. (10 points)
2. Does the applicant provide sufficient evidence that the intervention
3. Does the applicant provide sufficient evidence suggesting that the innovative HIV behavioral intervention has worked in the past? Do they provide data from pre- and post-intervention monitoring of outcomes such as behavioral, psychosocial, biologic, or process outcome data supporting positive HIV risk reduction that can be directly attributed to the intervention? (10 points)
4. Does the applicant explain why they think the innovative intervention works? Do they refer to specific activities, processes or steps that led to their observed results, or do they base their explanation on current behavioral change theories (which could include a logic model)? (5 points)
1. Does the applicant have sufficient technical and programmatic capacity and a proven track record to implement and evaluate the intervention in the community? (5 points)
2. Does the applicant have the capacity to recruit and enroll at least 200 people within one year of the evaluation? Have they provided evidence of prior success in retaining intervention participants? (5 points)
3. If partnerships with locally-based evaluation specialists, evaluation organizations, universities, or health departments are cited in the application, do the partners demonstrate sufficient expertise to help achieve the project goals? (5 points)
4. Are the staffing and training plans for the CBO and partner organization (if applicable) adequate to properly implement and evaluate the intervention? If CBO staff will be used to perform the outcome evaluation activities, have they demonstrated that the roles of intervention staff and evaluation staff will be kept distinct and separate to ensure objectivity? (5 points)
1. Does the applicant reasonably justify the HIV prevention needs of the targeted minority population? To help answer this question, review the information provided in Appendix B (Target Population Characteristics) to determine whether the applicant has sufficiently described the racial and ethnic composition of the targeted population and the behaviors or circumstances that place the targeted population at high risk for HIV infection or for transmitting the HIV virus. Proposals that seek to evaluate interventions designed for minority HIV seropositive people or interventions designed for minority populations not well-represented among interventions listed in the Compendium of HIV Prevention Interventions with Evidence of Effectiveness (examples include but are not limited to men who have sex with men, migrants, commercial sex workers, and transgendered) should be given high priority. (4 points)
2. How well does the target population reflect HIV community planning priorities? (3 points)
3. Rate the strength of proof provided by the applicant that it has very significant experience in proving HIV prevention services to the targeted racial/ethnic minority population. This proof should include a history of the CBO's service to the population that includes an explanation of how long the CBO has provided services to the population, the kinds of services provided, the outcomes of services provided, and the CBO's relationship with the community (3 points)
Are the specific aims of the proposed evaluation adequately described and consistent with the objectives of this cooperative agreement?
This section of your application will be reviewed to determine if you are eligible for funding. All supporting documents were placed in Appendix A: Proof of Eligibility.
The budget will be reviewed to determine the extent to which it is reasonable, clearly justified, itemized, consistent with the intended use of funds, and allowable.
Applications will be reviewed for completeness by the Procurement and Grants Office (PGO) staff, and for responsiveness and eligibility (Appendix A: Proof of Eligibility) by NCHSTP. Incomplete applications and applications that are non-responsive to the eligibility criteria will not advance through the review process. Applicants will be notified that their application did not meet submission requirements.
An objective review panel will evaluate all complete and responsive applications according to the criteria listed in the “V.1. Criteria” section above.
September 1, 2004.
If your CBO is funded, you will receive a Notice of Grant Award (NGA) from the CDC Procurement and Grants Office. The NGA shall be the only binding, authorizing document between the recipient and CDC. The NGA will be signed by an authorized Grants Management Officer, and mailed to the recipient fiscal officer identified in the application.
Unsuccessful applicants will receive notification of the results of the application review by mail.
For more information on the Code of Federal Regulations, see the National Archives and Records Administration at the following Internet address:
The following additional requirements apply to this project:
• AR-4 HIV/AIDS Confidentiality Provisions
• AR-5 HIV Program Review Panel Requirements
• AR-8 Public Health System Reporting Requirements
• AR-9 Paperwork Reduction Act Requirements
• AR-10 Smoke-Free Workplace Requirements
• AR-11 Healthy People 2010
• AR-12 Lobbying Restrictions
• AR-14 Accounting System Requirements
• AR-15 Proof of Non-Profit Status
Additional information on these requirements can be found on the CDC web site at the following Internet address:
You must provide CDC with an original, plus two hard copies of the following reports:
1. Interim progress report, no less than 90 days before the end of the budget period. The progress report will
a. Current Budget Period Activities Objectives.
b. Current Budget Period Financial Progress.
c. New Budget Period Program Proposed Activity Objectives.
d. Budget.
e. Additional Requested Information.
f. Measures of Effectiveness.
2. Financial status report and annual progress report, no more than 90 days after the end of the budget period.
3. Final financial and performance reports, no more than 90 days after the end of the project period.
These reports must be mailed to the Grants Management or Contract Specialist listed in the “Agency Contacts” section of this announcement.
For general questions about this announcement, contact: Technical Information Management Section, PA 04249, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770-488-2700.
For program technical assistance, contact: Tomas Rodriguez, CDC, NCHSTP, Mailstop E-37, 1600 Clifton Rd, NE, Atlanta, GA 30333, ph: (404) 639-5240, fax: (404) 639-1950, email:
For financial, grants management, or budget assistance, contact: Betty Vannoy, Contract Specialist, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770-488-2897, E-mail:
In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC) announces the following meeting:
Trudy Messmer, PhD., Scientific Review Administrator, Centers for Disease Control, National Center for Infectious Diseases, 1600 Clifton Road NE, Mailstop C19, Atlanta, GA 30333, Telephone 404.639.3770.
The Director, Management Analysis and Services Office, has been delegated the authority to sign
In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC) announces the following meeting: The Epidemiological Follow-up of Thyroid Disease in Persons Exposed to Radioactive Fallout from Atomic Weapons Testing at the Nevada Test Site, Program Announcement Number 04173.
The Director, Management Analysis and Services Office, has been delegated the authority to sign
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (DHHS).
Notice of an evaluation study and request for public comment.
This notice announces a study to evaluate the effectiveness of Brain Heart Infusion Agar plates containing 6 μg of vancomycin (BHI-V) per ml to detect Vancomycin-resistant
The CDC would like manufacturers of BHI-V to submit a total of 120 agar plates, 40 plates each of three different lots of BHI-V agar, for testing. The protocol is available on request.
The purpose of this study is to validate the use of BHI-V agar plates, which are currently approved by the Food and Drug Administration in the United States for detecting vancomycin-resistant
Comments on the CDC Evaluation of Brain Heart Infusion Agar plates containing 6 μg of vancomycin per ml to detect Vancomycin-resistant strains of
Dr. Roberta Carey at (404) 639-3032, e-mail:
Comments should be submitted to Dr. Roberta Carey, Centers for Disease Control and Prevention, National Center for Infectious Diseases, Division of Healthcare Quality Promotion (C-16), 1600 Clifton Rd., NE., Atlanta, GA 30333, or via e-mail:
Strains of
A notice and request for comments titled “National Health and Nutrition Examination Survey (NHANES) Stored Biologic Specimens: Guidelines for Proposals To Use Samples and Proposed Cost Schedule” was published in the
On page 29554, third column: the heading “Proposed Cost Schedule for Providing NHANES III DNA Specimen Bank” should now read: “Proposed Cost Schedule for Providing NHANES Stored Biologic Specimens.”
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a risk assessment regarding the potential for variant Creutzfeldt-Jakob Disease (vCJD) in humans from exposure to cosmetics containing cattle-derived protein infected with the bovine spongiform encephalopathy (BSE) agent. FDA is making this document available to communicate publicly the potential risk to public health from cosmetics made with cattle materials that may be contaminated with the BSE agent.
Submit written requests for single copies of the risk assessment to the Office of Plant and Dairy Foods (HFS-365), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send one self-addressed adhesive label to assist that office in processing your request, or include a fax number to which the document may be sent. Alternatively, you may request a copy of the document by calling 301-436-2367, or you may fax your request to 301-436-2632. See the
Morris Potter, Center for Food Safety and Applied Nutrition (HFS-006), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 404-253-1225.
Cosmetics may be made from a variety of cattle-derived ingredients. These ingredients include: Albumin, brain extract, brain lipid, cholesterol, fibronectin, sphingolipids, collagen, keratin, and tallow, and tallow derivatives. Tallow derivatives, particularly fatty acids and glycerin, are the predominant cattle ingredient used by the cosmetic industry. Cattle-derived ingredients serve many functions and may be used as skin conditioning agents, emollients, binders, and hair and nail conditioning agents.
There are several routes through which cosmetics contaminated with the agent that causes BSE could transmit disease to humans. Transmission of the BSE agent to humans through intact skin is not likely; however, cosmetics may be ingested or applied to cut or abraded skin or to mucosal tissues, particularly in the eye, which could provide direct routes for infection.
The risk assessment presents scientific evidence on the risk of transmission of vCJD to humans from cattle-derived ingredients used in the manufacture of cosmetics. FDA has prepared a qualitative assessment that follows the generally accepted framework for risk assessments endorsed by the Codex Alimentarius Commission. This framework involves the following steps:
(1)
(2)
(3)
(4)
The risk assessment also discusses the quality of information available for, and the uncertainties associated with, the assessment.
FDA has determined that this risk assessment is appropriate to the circumstances.
The risk assessment is available electronically at
Coast Guard, DHS.
Notice of policy; extension.
The Coast Guard is extending its policy for resolving conflicts between its own regulations on navigation equipment on ships and the recent amendments to the International Convention for the Safety of Life at Sea, 1974, (SOLAS). The amendments to SOLAS entered into force on July 1, 2002. Until the Coast Guard aligns its regulations with these amendments, this policy should benefit ship owners and operators by relieving them of the need to meet existing Coast Guard regulations that are incompatible with or duplicitous of the new SOLAS requirements.
This extension of policy is effective July 14, 2004.
Documents mentioned in this notice are part of docket USCG-2002-13057 and are available for inspection or copying at the Docket Management Facility, U.S. Department of Transportation, room PL-401, 400 Seventh Street SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. You may also find this docket on the Internet at
If you have questions on this notice, contact LCDR James Rocco, Office of Vessel Traffic Management, U.S. Coast Guard Headquarters, telephone (202) 267-0550; e-mail
In December 2000, the International Maritime Organization amended chapter V of the International Convention for the Safety of Life at Sea, 1974, (SOLAS) at the 73rd Session of the Maritime Safety Committee. The amendments were accepted by the Contracting Governments to SOLAS on January 1, 2002, and entered into force on July 1, 2002.
These amendments, in part, added requirements for the carriage of voyage data recorders (VDR) and automatic identification systems (AIS), changed the existing tonnage thresholds used to establish carriage requirements for some navigation equipment, and allowed an electronic chart display and information systems (ECDIS) to be accepted as meeting the chart carriage requirements of chapter V. Because of these amendments, the Coast Guard will need to align its regulations in titles 33 and 46 of the Code of Federal Regulations, especially those in 33 CFR part 164, with these amendments. Until this alignment occurs, problems may result because of the inconsistencies between SOLAS chapter V and Coast Guard regulations. For example, if a ship owner elects to install ECDIS, the ship may still be required under 33 CFR 164.33 to carry paper nautical charts.
Since publishing our initial policy statement on August 15, 2002 (67 FR 53382), we have implemented some SOLAS V amendment regulations. As part of our maritime security regulations, for example, we published an automatic identification system vessel carriage requirement final rule (68 FR 60559, October 22, 2003). But until the Coast Guard aligns all its regulations with the amendments to SOLAS chapter V, the following policy applies:
For ships to which this policy applies, when an amendment to chapter V and a provision in Coast Guard regulations address the same navigational safety concern and when applying both would result in an unnecessary duplication, the Coast Guard will accept the provision under chapter V as meeting the corresponding Coast Guard regulation. In other words, if a ship has an approved ECDIS installed according to chapter V, the ECDIS will be considered by the Coast Guard as meeting its nautical chart regulation in 33 CFR 164.33(a)(1), because the ECDIS meets the same navigational safety concerns as do paper nautical charts. This policy benefits the ship owner and operator by relieving them of the need to unnecessarily duplicate equipment.
Under SOLAS, chapter I, regulation 12, the Coast Guard will not issue SOLAS certificates to U.S.-flag ships that are not in full compliance with the applicable requirements of the new SOLAS, chapter V. The Coast Guard will continue to exercise port state control authority under SOLAS, chapter I, regulation 19, for foreign-flag ships that are not in compliance with the applicable requirements of SOLAS, chapter V. Also, U.S. flag vessels on international voyages, as defined in SOLAS, should be aware that foreign
This policy applies to the following ships, which are subject to the amendments to chapter V:
1. U.S.-flag ships of 150 or more gross tonnage that engage on international voyages.
2. U.S.-flag ships certificated solely for service on the Great Lakes and the St. Lawrence River as far east as a straight line drawn from Cap de Rosiers to West Point, Anticosti Island, and, on the north side of Anticosti Island, the 63rd Meridian.
3. Foreign-flag ships to which SOLAS, chapter V, applies that are operating on the navigable waters of the United States.
Note that U.S.-flag ships without mechanical means of propulsion are exempt from certain requirements of SOLAS under SOLAS, chapter V, regulation 3.1.
This policy is not applicable to U.S.-flag ships engaged only on domestic voyages. These ships must continue to comply with the existing navigation equipment requirements in titles 33 and 46 CFR.
This policy will remain in effect until titles 33 and 46 CFR are aligned with SOLAS, chapter V.
Federal Emergency Management Agency, Emergency Preparedness and Response Directorate, U.S. Department of Homeland Security.
Notice and request for comments.
The Federal Emergency Management Agency (FEMA) has submitted the following information collection to the Office of Management and Budget (OMB) for review and clearance in accordance with the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). The submission describes the nature of the information collection, the categories of respondents, the estimated burden (
Requests for additional information or copies of the information collection should be made to Muriel B. Anderson, Chief, Records Management, FEMA at 500 C Street, SW., Room 316, Washington, DC 20472, facsimile number (202) 646-3347, or email address
Federal Emergency Management Agency, Emergency Preparedness and Response Directorate, Department of Homeland Security.
Notice.
This is a notice of the Presidential declaration of a major disaster for the State of Arkansas (FEMA-1528-DR), dated June 30, 2004, and related determinations.
June 30, 2004.
Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472, (202) 646-2705.
Notice is hereby given that, in a letter dated June 30, 2004, the President declared a major disaster under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (the Stafford Act), as follows:
I have determined that the damage in certain areas of the State of Arkansas, resulting from severe storms and flooding on May 30, 2004, and continuing, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (the Stafford Act). I, therefore, declare that such a major disaster exists in the State of Arkansas.
In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes, such amounts as you find necessary for Federal disaster assistance and administrative expenses.
You are authorized to provide Public Assistance in the designated areas and Hazard Mitigation throughout the State, and any other forms of assistance under the Stafford Act you may deem appropriate. Direct Federal Assistance is authorized, if
Further, you are authorized to make changes to this declaration to the extent allowable under the Stafford Act.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Under Secretary for Emergency Preparedness and Response, Department of Homeland Security, under Executive Order 12148, as amended, Carlos Mitchell, of FEMA is appointed to act as the Federal Coordinating Officer for this declared disaster.
I do hereby determine the following areas of the State of Arkansas to have been affected adversely by this declared major disaster:
Bradley, Calhoun, Clark, Columbia, Hempstead, Howard, Lafayette, Little River, Nevada, Ouachita, Pike, and Sevier Counties for Public Assistance. Direct Federal Assistance is authorized, if warranted.
All counties within the State of Arkansas are eligible to apply for assistance under the Hazard Mitigation Grant Program.
Federal Emergency Management Agency, Emergency Preparedness and Response Directorate, Department of Homeland Security.
Notice.
This is a notice of the Presidential declaration of a major disaster for the State of California (FEMA-1529-DR), dated June 30, 2004, and related determinations.
June 30, 2004.
Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472, (202) 646-2705.
Notice is hereby given that, in a letter dated June 30, 2004, the President declared a major disaster under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (the Stafford Act), as follows:
I have determined that the damage in certain areas of the State of California, resulting from flooding as a result of a levee break on June 3, 2004, and continuing, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (the Stafford Act). I, therefore, declare that such a major disaster exists in the State of California.
In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes, such amounts as you find necessary for Federal disaster assistance and administrative expenses.
You are authorized to provide Public Assistance and Hazard Mitigation in the designated areas and any other forms of assistance under the Stafford Act you may deem appropriate. Consistent with the requirement that Federal assistance be supplemental, any Federal funds provided under the Stafford Act for Public Assistance and Hazard Mitigation will be limited to 75 percent of the total eligible costs. If Other Needs Assistance under Section 408 of the Stafford Act is later requested and warranted, Federal funding under that program will also be limited to 75 percent of the total eligible costs.
Further, you are authorized to make changes to this declaration to the extent allowable under the Stafford Act.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Under Secretary for Emergency Preparedness and Response, Department of Homeland Security, under Executive Order 12148, as amended, William L. Carwile, III, of FEMA is appointed to act as the Federal Coordinating Officer for this declared disaster.
I do hereby determine the following area of the State of California to have been affected adversely by this declared major disaster:
San Joaquin County for Public Assistance.
San Joaquin County within the State of California is eligible to apply for assistance under the Hazard Mitigation Grant Program.
Federal Emergency Management Agency, Emergency Preparedness and Response Directorate, Department of Homeland Security.
Notice.
This notice amends the notice of a major disaster for the State of Indiana (FEMA-1520-DR), dated June 3, 2004, and related determinations.
June 25, 2004.
Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472, (202) 646-2705.
Notice is hereby given that the incident period for this disaster is closed effective June 25, 2004.
Federal Emergency Management Agency, Emergency Preparedness and Response Directorate, Department of Homeland Security.
Notice.
This notice amends the notice of a major disaster declaration for the State of Iowa (FEMA-1518-DR), dated May 25, 2004, and related determinations.
July 2, 2004.
Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472, (202) 646-2705.
The notice of a major disaster declaration for the State of Iowa is hereby amended to include the following areas among those areas determined to have been adversely affected by the catastrophe declared a major disaster by the President in his declaration of May 25, 2004:
Appanoose and Lucas for Individual Assistance (already designated for Public Assistance).
Davis, Des Moines, Hamilton, Henry, Louisa, Monroe, Muscatine, Scott, Wapello, Washington, and Wayne for Individual Assistance.
Federal Emergency Management Agency, Emergency Preparedness and Response Directorate, Department of Homeland Security.
Notice.
This notice amends the notice of a major disaster declaration for the Commonwealth of Kentucky (FEMA-1523-DR), dated June 10, 2004, and related determinations.
June 30, 2004.
Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472, (202) 646-2705.
The notice of a major disaster declaration for the Commonwealth of Kentucky is hereby amended to include the following area among those areas determined to have been adversely affected by the catastrophe declared a major disaster by the President in his declaration of June 10, 2004:
Lincoln County for Public Assistance (already designated for Individual Assistance).
Federal Emergency Management Agency, Emergency Preparedness and Response Directorate, Department of Homeland Security.
Notice.
This notice amends the notice of a major disaster declaration for the Commonwealth of Kentucky (FEMA-1523-DR), dated June 10, 2004, and related determinations.
July 2, 2004.
Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472, (202) 646-2705.
The notice of a major disaster declaration for the Commonwealth of Kentucky is hereby amended to include the following areas among those areas determined to have been adversely affected by the catastrophe declared a major disaster by the President in his declaration of June 10, 2004:
Greenup County for Individual Assistance.
Boyd, Carter, and Jackson for Individual Assistance (already designated for Public Assistance.)
Federal Emergency Management Agency, Emergency Preparedness and Response Directorate, Department of Homeland Security.
Notice.
This is a notice of the Presidential declaration of a major disaster for the State of Michigan (FEMA-1527-DR), dated June 30, 2004, and related determinations.
June 30, 2004.
Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472, (202) 646-2705.
Notice is hereby given that, in a letter dated June 30, 2004, the President declared a major disaster under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. §§ 5121-5206 (the Stafford Act), as follows:
I have determined that the damage in certain areas of the State of Michigan, resulting from severe storms, tornadoes, and flooding on May 20-24, 2004, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (the Stafford Act). I, therefore, declare that such a major disaster exists in the State of Michigan.
In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes, such amounts as you find necessary for Federal disaster assistance and administrative expenses.
You are authorized to provide Individual Assistance and Hazard Mitigation in the designated areas, and any other forms of assistance under the Stafford Act you may deem appropriate. Consistent with the requirement that Federal assistance be supplemental, any Federal funds provided under the Stafford Act for Hazard Mitigation and the Other Needs Assistance under Section 408 of the Stafford Act will be limited to 75 percent of the total eligible costs. If Public Assistance is later warranted, Federal funds provided under that program will also be limited to 75 percent of the total eligible costs.
Further, you are authorized to make changes to this declaration to the extent allowable under the Stafford Act.
The time period prescribed for the implementation of section 310(a), Priority to Certain Applications for Public Facility and Public Housing Assistance, 42 U.S.C. 5153, shall be for a period not to exceed six months after the date of this declaration.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Under Secretary for Emergency Preparedness and Response, Department of Homeland Security, under Executive Order 12148, as amended, Marianne Jackson, of FEMA is appointed to act as the Federal Coordinating Officer for this declared disaster.
I do hereby determine the following areas of the State of Michigan to have been affected adversely by this declared major disaster:
Barry, Berrien, Cass, Genesee, Gladwin, Ingham, Ionia, Jackson, Kent, Livingston, Macomb, Mecosta, Oakland, Ottawa, Sanilac, Shiawassee, St. Clair, St. Joseph, and Wayne Counties for Individual Assistance.
Arenac, Barry, Berrien, Cass, Genesee, Gladwin, Ingham, Ionia, Jackson, Kent, Livingston, Macomb, Mecosta, Newaygo, Oakland, Ottawa, Saginaw, Sanilac, Shiawassee, St. Clair, St. Joseph, Van Buren, and Wayne Counties within the State of Michigan are eligible to apply for assistance under the Hazard Mitigation Grant Program.
Federal Emergency Management Agency, Emergency Preparedness and Response Directorate, Department of Homeland Security.
Notice.
This notice amends the notice of a major disaster for the State of Ohio (FEMA-1519-DR), dated June 3, 2004, and related determinations.
Effective Date: June 21, 2004.
Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472, (202) 646-2705.
Notice is hereby given that the incident period for this disaster is closed effective June 21, 2004.
Federal Emergency Management Agency, Emergency Preparedness and Response Directorate, Department of Homeland Security.
Notice.
This notice amends the notice of a major disaster declaration for the State of Ohio (FEMA-1519-DR), dated June 3, 2004, and related determinations.
July 2, 2004.
Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472, (202) 646-2705.
The notice of a major disaster declaration for the State of Ohio is hereby amended to include the following areas among those areas determined to have been adversely affected by the catastrophe declared a
Athens, Delaware and Tuscarawas Counties for Public Assistance (already designated for Individual Assistance.)
Holmes County for Public Assistance.
Federal Emergency Management Agency, Emergency Preparedness and Response Directorate, Department of Homeland Security.
Notice.
This notice amends the notice of a major disaster for the State of West Virginia (FEMA-1522-DR), dated June 7, 2004, and related determinations.
June 28, 2004.
Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472, (202) 646-2705.
Notice is hereby given that the incident period for this disaster is closed effective June 28, 2004.
Federal Emergency Management Agency, Emergency Preparedness and Response Directorate, Department of Homeland Security.
Notice.
This notice amends the notice of a major disaster for the State of Wisconsin (FEMA-1526-DR), dated June 18, 2004, and related determinations.
July 3, 2004.
Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472, (202) 646-2705.
Notice is hereby given that the incident period for this disaster is closed effective July 3, 2004.
Federal Emergency Management Agency, Emergency Preparedness and Response Directorate, Department of Homeland Security.
Notice.
This notice amends the notice of a major disaster declaration for the State of Wisconsin (FEMA-1526-DR), dated June 18, 2004, and related determinations.
July 2, 2004.
Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472, (202) 646-2705.
The notice of a major disaster declaration for the State of Wisconsin is hereby amended to include the following areas among those areas determined to have been adversely affected by the catastrophe declared a major disaster by the President in his declaration of June 18, 2004:
Office of the Chief Information Officer, HUD.
Notice.
The proposed information collection requirement described below has been submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal.
HUD is requesting renewal of approval to collect information from cities, counties, and states that have received program grants. Grantees describe their recovery needs, develop action plans, and report performance on a Disaster Recovery Grant Reporting System. HUD also uses the information for quarterly reports to Congress.
Comments Due Date: August 13, 2004.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB approval Number (2506-0165) and should be sent to: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503; fax: 202-395-6974.
Wayne Eddins, Reports Management Officer, AYO, Department of Housing and Urban Development, 451 Seventh Street, SW., Washington, DC 20410; e-mail
This Notice informs the public that the U.S. Department of Housing and Urban Development (HUD) has submitted to OMB, for emergency processing, a survey instrument to obtain information from faith based and community organizations on their likelihood and success at applying for various funding programs. This Notice is soliciting comments from members of the public and affecting agencies concerning the proposed collection of information to: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology,
This Notice also lists the following information:
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. 35, as amended.
Fish and Wildlife Service, Interior.
Notice of document availability.
The U.S. Fish and Wildlife Service (Service) announces the availability of the approved recovery plan for the Higgins eye pearlymussel (
Actions needed for recovery of the Higgins eye pearlymussel include alleviating threats posed by exotic species, especially zebra mussels (
This recovery plan is available from the following addresses:
1. Field Supervisor, U.S. Fish and Wildlife Service, Twin Cities Field Office, 4101 East 80th Street, Bloomington, MN 55425.
2. The World Wide Web at:
Mr. Phil Delphey, Twin Cities Field Office, (see
Recovery of endangered or threatened animals or plants is a primary goal of the Service's endangered species program. A species is considered recovered when its status has been improved to the point at which listing is no longer appropriate under the criteria set out in section 4(a)(1) of the Act. Recovery plans describe actions considered necessary for the conservation of the species, establish criteria for delisting species, and provide estimates of the time and cost for implementing the measures needed for recovery.
The Act requires the development of recovery plans for listed species unless such a plan would not promote the conservation of a particular species. Section 4(f) of the Act, as amended in 1988, requires that public notice and the opportunity for public review and comment be provided during recovery plan development. Information presented during the comment period has been considered in the preparation of the approved recovery plan and is summarized in an appendix to the recovery plan. We will forward substantive comments regarding recovery plan implementation to appropriate Federal agencies and other entities so that they can take these comments into account during the course of implementing recovery actions.
Higgins eye pearlymussel is a large river species occupying stable substrates that vary from sand to boulders; it does not occur in firmly packed clay, flocculent silt, organic material, bedrock, concrete or unstable sand. Water velocities should be less than 1 m/s during periods of low discharge. The species is usually found in mussel beds that contain at least 15 other species. The density of all mussels in the bed typically exceeds 10/m
The objective of the recovery plan is to provide a framework for the recovery of Higgins eye pearlymussel so that protection by the Act is no longer necessary. Higgins eye may be considered for reclassification from Endangered to Threatened when the following occurs: (1) At least five identified Essential Habitat Areas contain reproducing, self-sustaining populations of
Recovery will be achieved and the species removed from the list of Threatened and Endangered Wildlife (50 CFR part 17) when the following criteria are met: (1) Populations in at least five Essential Habitat Areas are reproducing, self-sustaining, not threatened by zebra mussels, and are sufficiently secure to assure long-term viability of the species; (2) zebra mussels are not present in locations where they or their offspring are likely to adversely affect
The authority for this action is section 4(f) of the Endangered Species Act, 16 U.S.C. 1533(f).
Fish and Wildlife Service, Interior.
Notice of availability.
The U.S. Fish and Wildlife Service (Service) is making available for public review a draft annual funding agreement (draft AFA or draft agreement) with the Confederated Salish and Kootenai Tribes (CSKT) under the Indian Self-Determination and Education Assistance Act, as amended by the Tribal Self-Governance Act of 1994. This action is taken at the discretion of the Service to provide public review opportunity and solicit comments from the public for a 90-day period.
Written comments should be received by October 12, 2004.
You may submit written comments and information to the U.S. Fish and Wildlife Service, National Bison Range, 132 Bison Range Road, Moiese, Montana 59824 or by facsimile to (406) 644-2661. You may hand-deliver written comments to the National Bison Range at the address given above. You may send comments by electronic mail (e-mail) to
You may obtain copies of the draft AFA, by appointment, during normal business hours, from the U.S. Fish and Wildlife Service, National Bison Range, 132 Bison Range Road, Moiese, Montana 59824, (406) 644-2211. In addition, copies may be obtained from U.S. Fish and Wildlife Service Regional Office, Mountain-Prairie Region, National Wildlife Refuge System, P.O. Box 25486, Denver, Colorado 80225-0486, (303) 236-4306, or from the Confederated Salish and Kootenai Tribes, P.O. Box 278, Pablo, Montana 59855, (406) 675-2700. The draft AFA is also available on the Internet at
Steve Kallin, Refuge Manager, National Bison Range, U.S. Fish and Wildlife Service, (406) 644-2211, extension 204.
In spring 2003, the Confederated Salish and
The Tribal Self-Governance Act of 1994 was enacted as an amendment to Pub. L. 93-638 and incorporated as Title IV of that Act. The Self-Governance Act allows qualifying self-governance tribes the opportunity to request AFAs with the Bureau of Indian Affairs (BIA) and non-BIA agencies within the Department of the Interior. When dealing with non-BIA agencies, including the Service, qualifying tribes may enter into AFAs that would allow them to conduct certain activities of such non-BIA agencies. Eligible activities include Indian programs (programs created for the benefit of Indians because of their status as Indians); activities otherwise available to Indian tribes (any activity that a Federal agency might otherwise contract to outside entities); and activities that have a special geographic, historical, or cultural significance to an Indian tribe.
Pub. L. 93-638 and the regulations that implement the law (25 CFR part 1000.129) prohibit the inclusion of activities in an AFA that are inherently Federal functions. The Refuge has no special Indian programs. All activities of the Service on national wildlife refuges are for the benefit of the fish and wildlife resources, their habitats, and the American public. Activities that may have a special relationship with a tribe are the most promising for inclusion in an AFA. Whether to enter into an agreement with a tribe for these activities is discretionary on the part of the Service. The Service recognizes that many members of the CSKT who live near the National Bison Range have a cultural, historical, or geographical connection to the land and resources of the National Bison Range and, therefore, may feel very much part of these lands. The proposed draft agreement provides for the CSKT to perform certain programs, services, functions, and activities for the National Bison Range Complex during a 1-year period.
Bureau of Indian Affairs, Interior.
Notice of Final Agency Determination to take land into trust under 25 CFR Part 151.
The Principal Deputy Assistant Secretary—Indian Affairs made a final agency determination to acquire approximately 1.71 acres of land into trust for the Agua Caliente Band of Cahuilla Indians of California on April 21, 2004. This notice is published in the exercise of authority delegated by the Secretary of the Interior to the Principal Deputy Assistant Secretary—Indian Affairs by 209 Departmental Manual 8.1.
George Skibine, Office of Indian Gaming Management, Bureau of Indian Affairs, MS-4543 MIB, 1849 C Street, NW., Washington, DC 20240; Telephone (202) 219-4066.
This notice is published to comply with the requirement of 25 CFR Part 151.12(b) that notice be given to the public of the Secretary's decision to acquire land in trust at least 30 days prior to signatory acceptance of the land into trust. The purpose of the 30-day waiting period in 25 CFR Part 151.12(b) is to afford interested parties the opportunity to seek judicial review of final administrative decisions to take land in trust for Indian tribes and individual Indians before transfer of title to the property occurs. On April 21, 2004, the Principal Deputy Assistant Secretary—Indian Affairs decided to accept approximately 1.71 acres of land into trust for the Agua Caliente Band of Cahuilla Indians of California under the authority of the Indian Reorganization Act of 1934, 25 U.S.C. 465. The 1.71 parcel is located with the exterior boundaries of the Agua Caliente Indian Reservation in Palm Springs, Riverside County, California. The parcel is an existing parking lot which supports the Band's Spa Resort and Casino.
The property is located within the exterior boundaries of the Agua Caliente Indian Reservation in Palm Springs, Riverside County, California and is described as follows:
A portion of Lot 69 of Section 14, Township 4 South, Range 4 East, San Bernardino Meridian as shown on the supplemental plat showing amended lottings in Section 14, Township 4 South, Range 4 East, San Bernardino Meridian prepared by the United States Department of the Interior, Bureau of Land Management, Washington, DC dated May 27, 1958, also shown as parcel 2 of parcel map No. 15314 recorded in Parcel Map Book 86 at page 100, records of Riverside County, California, described as follows: (
Commencing at the Northeast corner of said Lot 69;
Thence North 89°45′04″ West along the North line of said Lot 69, a distance of 34.80 feet;
Thence South 00°14′56″ West, a distance of 15.00 feet to the true point of beginning.
Thence North 89°45′04″ West and parallel to the northerly line of said Lot 69, a distance of 229.20 feet to the westerly line of said Lot 69;
Thence South 00°04′20″ East along the westerly line of said Lot 69, a distance of 299.92 feet to the Southwest corner thereof;
Thence South 89°45′00″ East along the southerly line of said Lot 69, a distance of 249.11 feet;
Thence North 00°04′35″ West and parallel to the East line of said Lot 69, a distance of 280.03 feet to the beginning of a tangent curve concave southwesterly and having a radius of 20.00 feet;
Thence northwesterly along said curve through a central angle of 80°40′29″ and a length of 31.30 feet to the true point of beginning.
Also shown as parcel 2 of Parcel Map No. 15314, in the City of Palm Springs, County of Riverside, State of California, on file in Book 86 of parcel maps, page 100, in the Office of the County Recorder of said County.
Bureau of Land Management, Interior.
Notice.
Pursuant to the Mineral Leasing Act of February 25, 1920, as amended, and Title 43, Code of Federal Regulations, Subpart 3410, members of the public are hereby invited to participate with Blue Mountain Energy, Inc. in a program for the exploration of unleased coal deposits owned by the United States of America beneath approximately 4,000.00 acres in Rio Blanco County, Colorado.
Written Notice of Intent to Participate should be addressed to the attention of the following persons and must be received by them by August 13, 2004.
Karen Purvis, CO-921, Solid Minerals Staff, Division of Energy, Lands and Minerals, Colorado State Office, Bureau of Land Management, 2850 Youngfield Street, Lakewood, Colorado 80215; and Jeff Dubbert, Blue Mountain Energy, Inc., 3607 County Road #65, Rangely, Colorado 81648.
Karen Purvis at (303) 239-3795.
The application for coal exploration license is available for public inspection during normal business hours under serial number COC 67737 at the Bureau of Land Management, Colorado State Office, 2850 Youngfield Street, Lakewood, Colorado 80215, and at the White River Field Office, 73544 Highway 64, Meeker, Colorado 81641. Any party electing to participate in this program must share all costs on a pro rata basis with Blue Mountain Energy, Inc. and with any other party or parties who elect to participate.
Bureau of Land Management, Interior.
Notice.
Mr. Richard L. Epstein and Ms. Carolyn Kernberger submitted an application for a recordable disclaimer of interest from the United States, pursuant to Section 315 of the Federal Land Policy and Management Act of 1976, as amended (43 U.S.C. 1745), for the following described land, in Socorro County:
A certain tract of land situate in Section 7, T. 2 S., R. 1 E., NMPM, being that accreted land lying westerly of and adjoining lot 3 and lot 4 of Section 7, T. 2 S., R. 1 E., NMPM. A recordable disclaimer of interest, if issued, will confirm the United States has no interest in the subject lands. This notice is intended to notify the public of the pending application and the applicants' grounds supporting it. The acres for this disclaimer are 30.54.
Jon Hertz, Assistant Socorro Field Office Manager at (505) 835-0412.
On May 15, 2003, Mr. Richard L. Epstein and Ms. Carolyn Kernberger filed an application for a recordable disclaimer of interest for lands that lie between the western boundary of their property and the Rio Grande. According to the applicant's, a cloud on their title presently exists because BLM has determined that these lands along the Rio Grande have accreted to their property. BLM Cadastral Survey examined the documents provided and agreed with the assessment that the accreted lands westerly of lots 3 and 4, and the 1981 riverbank in T. 2 S., R. 1 E., NMPM, section 7, do indeed attach to the private uplands described as lot 3 and lot 4.
All persons who wish to present comments, suggestions, or objections in connection with the proposed disclaimer may do so by writing to the Field Office Manager, Socorro Field Office, 198 Neel Avenue, NW., Socorro, NM 87801 until October 12, 2004. If no objections are received, the disclaimer will be published shortly after these 90 days have lapsed.
Bureau of Land Management, Interior.
Notice of availability of the final environmental impact statement (FEIS) for the Jack Morrow Hills Coordinated Activity Plan (JMH CAP), and proposed Resource Management Plan (RMP) amendment.
The Bureau of Land Management (BLM), in cooperation with the State of Wyoming, county governments, and conservation districts located within the planning area, announces the availability of the FEIS for the JMH CAP and Proposed Plan Amendment to the Green River RMP (1997). The FEIS documents the direct, indirect, and cumulative environmental impacts from the proposed CAP for the Jack Morrow Hills area within Sweetwater, Fremont, and Sublette Counties, Wyoming. The CAP will provide multiple use management direction for a variety of resource uses including energy resource development, recreational activities, livestock grazing, important wildlife habitat, cultural resources, special management areas (including areas of critical environmental concern), and other important resources and land uses in the planning area. The planning area encompasses approximately 622,000 acres, of which 585,000 acres are public land surface and Federal mineral estate administered by the BLM through its field office in Rock Springs, Wyoming.
Cooperating agencies under the National Environmental Protection Act (NEPA) in the preparation of the FEIS included the State of Wyoming and the following local Wyoming government entities: Sublette County, Popo Agie Conservation District, Sublette County Conservation District, Sweetwater County Conservation District, Fremont County, and Sweetwater County.
BLM published the Supplemental Draft Environment Impact Statement
The JMH CAP FEIS and Proposed Green River RMP Amendment will be available for review for 30 calendar days from the date the Environmental Protection Agency (EPA) publishes its Notice of Availability (NOA) in the
A copy of the FEIS has been sent to affected Federal, State, and local government authorities, and to other interested parties. The document will be available electronically on the following Web site:
Copies of the FEIS are available for public inspection at the following BLM office locations:
• Bureau of Land Management, Wyoming State Office, 5353 Yellowstone Road, Cheyenne, Wyoming 82009.
• Bureau of Land Management, Rock Springs Field Office, 280 Highway 191 North, Rock Springs, Wyoming 82901.
• Bureau of Land Management, Lander Field Office, 1335 Main Street, Lander, Wyoming 82520.
Michael R. Holbert, Field Manager, or Renee Dana, Jack Morrow Hills CAP Team Leader, Bureau of Land Management, Rock Springs Field Office, 280 Highway 191 North, Rock Springs, Wyoming 82901, 307-352-0256.
The FEIS analyzes five alternatives, including the no action alternative, ranging from preservation to full resource development. The alternatives provide and analyze specific management goals and objectives for the JMH CAP area. The approved CAP will include land and resource management decisions for fluid mineral leasing and mineral location that were deferred in the 1997 Green River RMP. The analysis conducted for the JMH CAP FEIS may be used to modify mineral decisions for the balance of the Green River RMP planning area. Consistent with regulations at 43 CFR 1610.5-5, modification or revision of mineral decisions made in the Green River RMP will require an amendment to that plan.
The BLM prepared and focused the impact analyses in the JMH CAP FEIS based on issues raised by the public during preparation of the Green River RMP and during the public scoping process for the CAP. The FEIS describes the physical, biological, cultural, historical, and socioeconomic resources in and surrounding the planning area. The JMH CAP provides management direction for the protection of important resources (
In addition, the JMH CAP FEIS includes use of a monitoring, evaluation, and implementation management approach. Based on monitoring of impacts, BLM proposes to adjust, as needed, management of transportation planning, off-highway-vehicular use designations, livestock grazing practices, recreational activities, rights-of-way corridors and avoidance areas, and prescriptions for managing wildlife habitat.
Of the 585,000 acres of Federal mineral estate administered by the BLM in the JMH planning area, 85,000 acres are within the core area where the Green River RMP fluid mineral leasing and mineral location decisions were deferred in 1997. The JMH CAP planning area includes the Steamboat Mountain, Greater Sand Dunes, Oregon Buttes, and White Mountain Petroglyphs Areas of Critical Environmental Concern (ACEC). Seven Wilderness Study Areas (WSAs) and part of the South Pass Historic Landscape ACEC are also located in the planning area.
The resource management planning process includes an opportunity for administrative review of proposed land use plan decisions during a 30-day protest period of the JMH CAP FEIS. Any person who participated in the planning process for the JMH CAP EIS and has an interest which is, or may be, adversely affected, may protest the JMH CAP FEIS proposed land use plan decisions to the BLM Director.
Ultimately, the BLM State Director's decision whether to adopt, reject or modify the proposed RMP amendment will be documented in a Record of Decision issued under the authority of the Federal Land Policy and Management Act, as codified at 43 CFR part 1610. Decisions regarding site-specific implementation activities will be subject to further NEPA analysis and appeal, as provided by applicable regulations.
Publication of this FEIS affords the public the opportunity to protest the JMH CAP. Instructions for filing a protest with the Director of the BLM regarding the State Director's proposed amendment to the Green River RMP may be found at 43 CFR 1610.5. Any person who participated in the planning process and has an interest in, or may be adversely affected by, the approval of the proposed Plan Amendment may protest such approval. A protest may raise only those issues submitted for the record during the planning process. The protest must be in writing and must be filed with the Director within 30 days from the date the EPA publishes the NOA for this FEIS in the
i. The name, mailing address, telephone number, and interest of the person filing the protest;
ii. A statement of the issue or issues being protested;
iii. A statement of the part, or parts, of the plan or amendment being protested;
iv. A copy of all documents addressing the issue, or issues, that were submitted during the planning process by the protesting party or an indication of the date the issue, or issues, were discussed for the record; and
v. A concise statement explaining why the State Director's decision is believed to be wrong.
The Director's decision on the protest will be in writing and will set forth the reasons for the decision. The decision will be sent to the protesting party by certified mail, return receipt requested. The Director's decision is the final decision for the Department of the Interior.
Bureau of Land Management, Interior.
Notice of intent.
In accordance with the Federal Land Policy and Management Act of 1976 (43 U.S.C. 1701), as amended; the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321), as amended; and the Council on Environmental Quality (CEQ) regulations (40 CFR parts 1500-1508), the Bureau of Land Management (BLM) will prepare a Resource Management Plan (RMP) for Eastern San Diego County and a Environmental Impact Statement (EIS) to evaluate the effects of land and resource management decisions in the Eastern San Diego County Planning Area.
BLM will accept written and electronic comments on the scope of the RMP until October 12, 2004 and received by October 22, 2004, and electronic comments received by October 12, 2004. Additional opportunities for public involvement, including a schedule of public meetings, will be announced separately from this notice in local newspapers.
You may submit comments by the following methods: Written: Lynnette Elser, Eastern San Diego County Resource Management Plan and EIS, 1661 South 4th Street, El Centro, CA 92243. Electronic:
For general information, including information on how to comment, you may contact Lynnette Elser, Bureau of Land Management, El Centro Field Office, 1661 South 4th Street, El Centro, CA or phone (760) 768-4400.
Individual respondents may request confidentiality. If you wish BLM to withhold your name or street address, except for the city or town, from public view or from disclosure under the Freedom of Information Act, you must state this prominently at the beginning of your written comment. We will honor requests to the extent allowed by law. All submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, will be available for public inspection in their entirety.
The intent of the current Resource Management Plan and EIS preparation process is to analyze and update land and resource management objectives within the Planning Area. The Resource Management Plan will consider: impacts posed by rapid population and community growth, the need to make resource decisions that are scientifically sound, legally defensible and sustainable resource decisions, the need to provide access to significant energy sources and communication sites, the need for utility corridors, the need for continuation of grazing activities, the need to maximize use of public lands in species recovery and habitat conservation, and the need to provide adequate facilities for safe recreation and visitation on the public lands.
Issues to be addressed in the Resource Management Plan will include recreation, off-highway vehicle use, routes-of-travel designations, wildlife, botanical resources, endangered species, cultural resources, Native American concerns, visual resources, livestock grazing, wilderness, fire management, and mining. Existing wilderness study areas designations will be evaluated. Boundaries and existence of currently designated wilderness areas will not be changed. Compatibility with management plans proposed by other public land management entities for adjacent lands will be considered.
The Resource Management Plan and EIS will be prepared by an interdisciplinary team with specialists for recreation, wilderness, botany, biology, archeology, wildlife, range management, realty, visual resources, geology and mining, range management and planning.
The approved Resource Management Plan will replace the existing East San Diego County Framework Management Plan as the document guiding land and resource management decisions on BLM-administered lands in the Planning Area.
Bureau of Land Management, Interior.
Notice.
This notice solicits public comment as to whether the area of Sweetwater County, Wyoming, described below meets the criteria set forth below for a Mechanically Mineable Trona Area (MMTA).
Comments should be submitted to the below address no later than August 13, 2004.
Written comments should be addressed to: Assistant Field Manager, Minerals and Lands, Bureau of Land Management, Rock Springs Field Office, 280 Highway 191 North, Rock Springs, Wyoming 82901.
Ted Murphy, Assistant Field Manager, Rock Springs Field Office, at (307) 352-0321.
An MMTA generally defines an area underlain by trona (sodium) deposits of the proper depth, thickness, and quality to support extraction by mining techniques that require an underground workforce. The lands described below are proposed to be included within the MMTA:
Containing 317,321.45 acres, more or less.
Bureau of Land Management, Interior.
Notice.
In accordance with Title IV of the Federal Oil and Gas Royalty Management Act (Pub. L. 97-451), a petition for reinstatement of oil and gas lease UTU78025 for lands in Uintah County, Utah, was timely filed and required rentals accruing from January 1, 2004, the date of termination, have been paid.
Teresa Catlin, Chief, Branch of Fluid Minerals at (801) 539-4122.
The lessee has agreed to new lease terms for rentals and royalties at rates of $10 per acre and 16
Having met all the requirements for reinstatement of the lease as set out in section 31(d) and (e) of the Mineral Leasing Act of 1920 (30 U.S.C. 188), the Bureau of Land Management is proposing to reinstate lease UTU78025, effective January 1, 2004, subject to the original terms and conditions of the lease and the increased rental and royalty rates cited above.
Bureau of Land Management, Interior.
Notice.
The following described public land in Las Vegas, Clark County, Nevada has been examined and found suitable for change of use and lease/conveyance for recreational or public purposes under the provisions of the Recreation and Public Purposes Act, as amended (43 U.S.C. 869
Anna Wharton, Supervisory Realty Specialist, (702) 515-5095.
This land was previously classified, segregated and leased to the Clark County Library District under BLM serial number N-66077.
Containing 11.25 acres, more or less.
The land is not required for any federal purpose. The lease/conveyance is consistent with current Bureau planning for this area and would be in the public interest. The City of Las Vegas proposes to build a low impact park that will consist of picnic areas, walking trails, open space and tot lot play areas. This land is located in the northwest sector of the Las Vegas valley and will serve citizens of all ages and abilities. The lease/patent, when issued, will be subject to the provisions of the Recreation and Public Purposes Act and applicable regulations of the Secretary of the Interior, and will contain the following reservations to the United States:
1. A right-of-way thereon for ditches or canals constructed by the authority of the United States, Act of August 30, 1890 (43 U.S.C. 945).
2. All minerals shall be reserved to the United States, together with the right to prospect for, mine and remove such deposits from the same under applicable law and such regulations as the Secretary of the Interior may prescribe.
And will be subject to:
1. All valid and existing rights.
2. Those rights for public utility purposes which have been granted to Nevada Power Company by Permit No. N-77096, under the Federal Land Policy and Management Act of October 21, 1976 (FLPMA).
3. Those rights for public utility purposes which have been granted to the Las Vegas Valley Water District by permit No. N-55369, under the Federal Land Policy and Management Act of October 21, 1976 (FLPMA).
4. Those rights for public utility purposes which have been granted to the Las Vegas Valley Water District by permit No. N-66231, under the Federal Land Policy and Management Act of October 21, 1976 (FLPMA).
5. Those rights for public utility purposes which have been granted to Central Telephone by permit No. N-53652, under the Federal Land Policy and Management Act of October 21, 1976 (FLPMA).
6. Those rights for sewer purposes which have been granted to the City of Las Vegas by permit No. N-62107, under the Federal Land Policy and Management Act of October 21, 1976 FLPMA).
7. Those rights for sewer purposes which have been granted to the City of Las Vegas by permit No. N-74262, under the Federal Land Policy and Management Act of October 21, 1976 (FLPMA).
8. Those rights for natural gas pipeline purposes which have been granted to Southwest Gas Corporation by permit No. N-57864 under Sec. 28 of the Mineral Leasing Act of 1920. Detailed information concerning this action is available for review at the
Bureau of Land Management (BLM), Interior.
Notice of realty action.
An 8.78 acre parcel in Klamath County, Oregon, is being considered for a direct sale to the Bonanza View Dairy to resolve an unintentional unauthorized use involving lands that are under the jurisdiction of the BLM. Bonanza View Dairy owns the adjacent lands next to the BLM parcels. BLM and the Public have legal access to the public lands via an easement purchased from Bonanza View Dairy on August 28, 1972. No significant resource values will be affected by this disposal. The parcels proposed for sale are identified as suitable for disposal in the Klamath Falls Resource Area Resource Management Plan, dated June 2, 1995.
Submit comments on or before August 30, 2004.
Address all written comments concerning this notice to Jon Raby, Klamath Falls Resource Area Field Manager, Klamath Falls Field Office, 2795 Anderson Ave., Building 25, Klamath Falls, Oregon 97603. Electronic format submittal will not be accepted.
Linda Younger, Realty Specialist, at (541) 883-6916.
The following described public land in Klamath County, Oregon, is suitable for sale under Sections 203 and 209 of the Federal Land Policy and Management Act of 1976 (90 Stat. 2750, 43 U.S.C. 1713 and 1719). The parcels proposed for sale are identified as follows:
The area described contains 8.78 acres, more or less. These parcels have been examined and found suitable for sale at not less than the appraised market value. The appraised market value for these parcels has been determined to be $3,160.00.
In accordance with 43 CFR 2711.3-3(a)(5), direct sale procedures may be utilized to resolve inadvertent unauthorized use or occupancy of the lands.
The proponent, Bonanza View Dairy, will be allowed 30 days from receipt of a written offer to submit a deposit of at least 20 percent of the appraised market value of the parcel, and 180 days thereafter to submit the balance.
The following rights, reservations, and conditions will be included in the patent conveying the land:
1. A reservation to the United States for a right-of-way for ditches and canals constructed by the authority of the United States. Act of August 30, 1890 (43 U.S.C. 945).
2. A reservation to the United States for all oil, gas and geothermal resources in the land in accordance with Section 209 of the Federal Land Policy and Management Act of 1976 (43 U.S.C. 1719).
3. The patent would also include a notice and indemnification statement under the Comprehensive Environmental Response, Compensation and Liability Act (42 U.S.C. 9620) holding the United States harmless from any release of hazardous materials that may have occurred as a result of the unauthorized use of the property by other parties.
The mineral interests being offered for conveyance have no known mineral value. Acceptance of a direct sale offer constitutes an application for conveyance of the mineral interest. In addition to the full purchase price, a nonrefundable fee of $50 will be required for the purchase of the mineral interests to be conveyed simultaneously with the sale of the land, with the exception of all leaseables, including oil, gas and geothermal interests, which will be reserved to the United States in accordance with Section 209 of the Federal Land Policy and Management Act of 1976 (43 U.S.C. 1719).
The land described is segregated from appropriation under the public land laws, including the mining laws, with the exception of sales under the above cited statutes, pending disposition of this action or 270 days from the date of publication of this notice, whichever occurs first.
Detailed information concerning this land sale, including the reservations, sale procedures and conditions, appraisal, planning and environmental documents, and mineral report is available for review at the Klamath Falls Field Office, Bureau of Land Management, 2795 Anderson Ave. Building 25, Klamath Falls, Oregon 97603.
Objections will be reviewed by the Lakeview District Manager who may sustain, vacate, or modify this realty action. In the absence of any objections, this proposal will become the final determination of the Department of the Interior.
Comments, including names, street addresses, and other contact information of respondents, will be available for public review. Individual respondents may request confidentiality. If you wish to request that BLM consider withholding your name, street address, and other contact information (such as: Internet address, FAX or phone number) from public review or from disclosure under the Freedom of Information Act, you must state this prominently at the beginning of your comment. BLM will honor requests for confidentiality on a case-by-case basis to the extent allowed by law.
BLM will make available for public inspection in their entirety all
Bureau of Land Management (BLM), Interior.
Notice of realty action.
An area of approximately 1.16 acres of public land in Baker County has been examined and found suitable for classification for lease to Baker County under the provisions of the Recreation and Public Purposes Act, as amended (43 U.S.C. 869
Submit comments on or before August 30, 2004.
Address all written comments concerning this Notice to Penelope Dunn Woods, Field Manager, Baker Field Office, 3165 10th Street, Baker City, Oregon 97814. Electronic format submittal will not be accepted.
Steve Davidson, Realty Specialist, Baker Field Office, Vale District, at (541) 523-1349.
The proposed lease area lies adjacent to Highway 86 and is within the following described public land:
The proposed lease area contains 1.16 acres, more or less, in Baker County, Oregon. The land is not needed for Federal purposes. The lease is consistent with the Baker Resource Management Plan of July 12, 1989, and would be in the public interest.
The lease, when issued, will be subject to the following terms, conditions and reservations:
1. Provisions of the Recreation and Public Purposes Act and to all applicable regulations of the Secretary of the Interior.
2. All valid existing rights documented on the official public land records at the time of lease issuance.
3. All minerals shall be reserved to the United States, together with the right to prospect for, mine, and remove the minerals.
4. Any other reservations that the authorized officer determines appropriate to ensure public access and proper management of Federal lands and interests therein.
Upon publication of this notice in the
Comments, including names, street addresses, and other contact information of respondents, will be available for public review. Individual respondents may request confidentiality. If you wish to request that the BLM consider withholding your name, street address and other contact information,
Any adverse comments will be reviewed by the State Director. In the absence of any adverse comments, the classification will become effective 60 days from the date of publication of this notice in the
Bureau of Land Management, Interior.
Notice.
Notice is hereby given that certain lands will be temporarily closed or restricted, and certain activities will be temporarily prohibited, in and around the Burning Man event site, Pershing and Washoe Counties, Nevada, for camping, vehicle use, fire use, and aircraft landing from 0600 hours, August 25, 2004, to 2200 hours, September 6, 2004. Certain lands will be temporarily closed or restricted, and certain activities will be temporarily prohibited, in the Winnemucca District in Pershing and Washoe Counties, Nevada, for fireworks use and firearms use from 0600 hours, August 16, 2004, to 2200 hours, September 20, 2004. A closure to all public uses will be in effect inside the perimeter fence surrounding the event from August 27, 2004 to September 6, 2004. These closures, restrictions and prohibitions are being made in the interest of public safety at and around the public lands location of an event known as the Burning Man Festival. This event is expected to attract approximately 30,000 participants this year. The lands involved are located in northwestern Nevada partially within the Black Rock Desert-High Rock Canyon Emigrant Trails National Conservation Area.
August 16, 2004 to September 20, 2004.
Dave Cooper, National Conservation Area Manager, Bureau of Land
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Official art burns, authorized event fireworks, and other authorized fires using Black Rock City LLC/Burning Man-supplied fire barrels or approved platforms. Fire Restriction Orders may be in effect pursuant to 43 CFR 9212.2, 36 CFR 261.50(a)(b) for all lands managed by the BLM, Winnemucca Field Office.
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A map showing these temporary closures, restrictions and prohibitions is available from the following BLM office: BLM-Winnemucca Field Office, 5100 East Winnemucca Blvd., Winnemucca, Nevada 89445.
The map may also be viewed on the Field Office Web site at:
Any person failing to comply with the closure orders may be subject to imprisonment for not more than 12
43 CFR 8364.1.
Bureau of Land Management, Interior.
Proposed supplementary rules.
The Bureau of Land Management (BLM) is publishing proposed supplementary rules that implement vehicular closure and restrictions to protect the values of the Snake River area and the Sheep Mountain Wilderness Study Area (WSA)/Area of Critical Environmental Concern (ACEC) on public lands along the West side of the Snake River between Oxbow and Brownlee Dam in Baker County, Oregon. The purpose of the closure and restrictions are to allow for the rehabilitation of newly constructed roads, trails, and ways, created or opened during the Idaho Power
You must submit your comments for these proposed supplementary rules to BLM at the appropriate address below on or before August 13, 2004. BLM may not consider any comments received after the above date in making its decisions on the final rule.
Mail or personal delivery: Field Manager, Bureau of Land Management, Baker Resource Area, 3165 10th Street, Baker City, Oregon 97814.
Baker Field Manager Penelope Dunn Woods, at (541) 523-1256. Persons who use a telecommunications device for the deaf (TDD) may contact this individual by calling the Federal Information Relay Service (FIRS) at (800) 877-8339, 24 hours a day, 7 days a week.
You may view an electronic version of this proposed rule at BLM's Internet home page:
Written comments on the proposed rule should be specific, confined to issues pertinent to the proposed rule, and should explain the reason for any recommended change. Where possible, comments should reference the specific section or paragraph of the proposal which the commenter is addressing. BLM may not consider or include in the Administrative Record for the final rule comments which BLM receives after the close of the comment period (
Comments, including names, street addresses, and other contact information of respondents, will be available for public review at the Baker Field Office, 3165 10th Street, Baker City, OR 97814 during regular business hours (7:45 a.m. to 4:30 p.m.), Monday through Friday, except Federal holidays. Individual respondents may request confidentiality. If you wish to request that BLM consider withholding your name, street address, and other contact information (such as: Internet address, FAX or phone number) from public review or from disclosure under the Freedom of Information Act, you must state this prominently at the beginning of your comment. BLM will honor requests for confidentiality on a case-by-case basis to the extent allowed by law. BLM will make available for public inspection in their entirety all submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses.
These supplementary rules will apply to the public lands within the Baker Resource Area of the Vale District. BLM has determined these rules necessary to protect the area's natural resources, to provide for safe public recreation and public health, and to reduce the potential for damage to the environment.
The public lands in Baker County, Oregon affected by this order include all BLM-managed public lands located within the identified sections, and all other BLM lands located between these sections and the Idaho Power Oxbow-Brownlee Road along the Oxbow Reservoir:
This closure and use restriction order is the minimum required to mitigate the impacts of unregulated off-highway vehicle use on newly disturbed soil, roads, trails, and ways; to protect wildlife habitat, cultural resources, scenic values, native vegetation and fragile soils in the area; and to respond to concerns of public health and safety, wildfire, weed control and resource degradation. Actions to implement the closure and restrictions will be undertaken.
Copies of the closure and restriction order and maps showing the location of the closed lands and roads are available from the Baker Field Office, 3165 10th Street, Baker City, OR 97814.
The proposed rule does not represent a government action capable of interfering with constitutionally protected property right as it only applies to lands managed by the BLM. Therefore, the Department of the
The proposed rule will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, BLM has determined that this proposed rule does not have sufficient federalism implications to warrant preparation of a federalism assessment.
Under Executive Order 12988, the Office of the Solicitor has determined that this proposed rule would not unduly burden the judicial system and that it meets the requirements of sections 3(a) and 3(b)(2) of the Order.
In accordance with Executive Order 13175, we have found that this proposed rule does not include policies that have tribal implications. The rule expressly does not apply to Indian lands (
In compliance with the National Environmental Policy Act, construction of the powerline, and the associated construction and rehabilitation of roads and trails, were analyzed in the Brownlee-Oxbox #2 Transmission Line Project Environmental Analysis. A Finding of No Significant Impact (FONSI) was issued on July 7, 2003. The Environmental Analysis states that the access roads that were to be built would be rehabilitated and would not be open to motorized public access. These supplementary rules serve as additional public notification that the powerline access roads will be closed to public vehicular use and provides BLM Law Enforcement Officers with the ability to enforce this closure. A copy of the Environmental Analysis and FONSI are available for review at the Baker Field Office (
These supplementary rules do not contain information collection requirements that the Office of Management and Budget must approve under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501
The principal author of these supplementary rules is Kevin McCoy, Outdoor Recreation Planner, Baker Field Office, 3165 10th Street, Baker City, OR, 97814.
Under the authority for supplemental rules found under 43 CFR 8365.1-6 and 43 U.S.C. 315a, the BLM will enforce the following rules on public lands within the affected area of the Snake River area and the Sheep Mountain WSA/ACEC at the locations identified in this order. You must follow these rules:
1. You must not operate any motorized vehicle within the affected Snake River area and Sheep Mountain WSA/ACEC areas, except on the existing improved Idaho Power Oxbow-Brownlee road on BLM public land. The Idaho Power Oxbow-Brownlee road is located on the west bank of the Snake River, from the Oxbow Dam upstream to the Brownlee Dam:
2. You must not land any motorized aircraft without authorization.
3. You must not park vehicles on public lands, except within established turnout areas no more than 100 feet from the west edge of the Idaho Power Oxbow-Brownlee road.
Notice is hereby given that on July 1, 2004, a proposed consent decree in
The consent decrees settle claims against owners of residential housing principally in Minneapolis, which were brought on behalf of the Department of Housing and Urban Development and the Environmental Protection Agency under the Residential Lead-Based Paint Hazard Reduction Act, 42 U.S.C. 4851
Under the
Under the
The Department of Justice will receive for a period of thirty (30) days from the date of this publication comments relating to the consent decrees. Comments should be addressed to the Assistant Attorney General of the Environment and Natural Resources Division, Department of Justice, P.O. Box 7611, Washington, DC 20044-7611, and should refer to
The proposed consent decrees may be examined at the Department of Housing and Urban Development, Office of Healthy Homes and Lead Hazard Control, attention: Tara Jordan, 490 L'Enfant Plaza, SW., Room 3206, Washington, DC 20410, (202) 755-1785, ext. 157; at the office of the United States Attorney for the District of Minnesota, 600 U.S. Courthouse, 300 South Fourth Street, Minneapolis, Minnesota 55415, and at U.S. EPA Region 5, 77 W. Jackson Boulevard, Chicago, Illinois 60604. During the public comment period, the consent decrees may also be examined on the following Department of Justice Web site,
Notice is hereby given that, on June 28, 2004, proposed Consent Decrees in
In this action, the United States brought suit pursuant to the Oil Pollution Act of 1990 (“OPA”), 33 U.S.C. 2701
The Department of Justice will receive, for a period of thirty (30) days from the date of this publication, comments relating to the Consent Decrees. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, P.O. Box 7611, U.S. Department of Justice, Washington, DC 20044-7611, and should refer to
The Consent Decrees may be examined at the Office of the United States Attorney, at 501 I Street, Suite 10-100 Sacramento, California 95814-2322. During the public comment period, the Consent Decrees may also be examined on the following Department of Justice Web site
Notice is hereby given that International Sign Association (“ISA”), successor in interest to National Electric Sign Association (“NESA”), a defendant in
On December 18, 1951, the United States filed a complaint against NESA and three individual defendants who were members of NESA. The complaint alleged that NESA excluded from membership in its Supply distributor Section any parts distributor who also engaged in the manufacture of electric signs or who resold sign parts at less than the parts manufacturers' suggested resale price. The complaint also charged that NESA attempted to coerce parts manufacturers into selling parts only to parts distributors and not directly to sign manufacturers or to parts distributors also engaged in the business of manufacturing signs.
On April 5, 1954, defendants entered a consent decree. Under the decree, defendants were restrained from discriminatory conduct in granting membership in NESA or in charging dues to NESA members. The decree also required defendants to amend NESA's bylaws so as to incorporate Sections V and VI of the Final Judgment and to furnish to each of its present and future members a copy of the Final Judgment.
The Department has filed with the Court a memorandum setting forth the reasons why the United States believes that termination of the Final Judgment would serve the public interest. Copies of defendants' motion papers, the stipulation containing the United States' tentative consent, the United States' memorandum, and all further papers filed with the Court in connection with this motion will be available for inspection at the Antitrust Documents Group, Antitrust Division, Room 213, 325 7th Street, NW., Washington, DC 20004, and at the Office of the Clerk of the United States District Court for the Northern District of Illinois, Eastern Division. Copies of these materials may be obtained from the Antitrust Division upon request and payment of the copying fee set by Department of Justice regulations.
Interested persons may submit comments regarding the proposed termination of the Final Judgment to the United States. Such comments must be received by the Antitrust Division within sixty (60) days and will be filed with the Court by the United States. Comments should be addressed to Maribeth Petrizzi, Chief, Litigation II Section, Antitrust Division, U.S. Department of Justice, 1401 H Street, NW., Suite 3000, Washington, DC 20530 (202-307-0924).
Notice is hereby given that, on June 15, 2004, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and Microcontaminant Reduction Venture intends to file additional written notification disclosing all changes in membership.
On June 13, 2001, Microcontaminant Reduction Venture filed its original notification pursuant to section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on August 14, 2003. A notice was published in the
Department of Justice, United States Parole Commission.
9:30 a.m., Tuesday, July 13, 2004.
5550 Friendship Blvd., Fourth Floor, Chevy Chase, MD 20815.
Open.
The following matters have been placed on the agenda for the open Parole Commission meeting:
1. Approval of Minutes of Previous Commission Meeting.
2. Reports from the Chairman, Commissioners, Legal, Chief of Staff, Case Operations, and Administrative Sections.
Thomas W. Hutchison, Chief of Staff, United States Parole Commission, (301) 492-5990.
The Bureau of International Labor Affairs, United States Department of Labor.
Request for information on efforts by certain countries to eliminate the worst forms of child labor.
This notice is a request for information for use by the Department of Labor in preparation of an annual report on certain trade beneficiary countries' implementation of international commitments to eliminate the worst forms of child labor. This will be the fourth such report by the Department of Labor under the Trade and Development Act of 2000 (TDA).
Submitters of information are requested to provide two (2) copies of their written submission to the International Child Labor Program at the address below by 5 p.m., August 13, 2004.
Written submissions should be addressed to Tina Faulkner at the International Child Labor Program, Bureau of International Labor Affairs, U.S. Department of Labor, 200 Constitution Avenue, NW., Room S-5307, Washington, DC 20210.
Tina Faulkner, Bureau of International Labor Affairs, International Child Labor Program, at (202) 693-4846; fax (202)
The Trade and Development Act of 2000 [Pub. L. 106-200], established a new eligibility criterion for receipt of trade benefits under the Generalized System of Preferences (GSP), Caribbean Basin Trade and Partnership Act (CBTPA), and Africa Growth and Opportunity Act (AGOA) programs. The TDA amends the GSP reporting requirements of the Trade Act of 1974 (Section 504) [19 U.S.C. 2464] to require that the President's annual report on the status of internationally recognized worker rights include “findings by the Secretary of Labor with respect to the beneficiary country's implementation of its international commitments to eliminate the worst forms of child labor.”
Likewise, Title II of the TDA includes as a criterion for receiving benefits under the CBTPA “whether the country has implemented its commitments to eliminate the worst forms of child labor, as defined in section 507(6) of the Trade Act of 1974.” The TDA Conference Report [Joint Explanatory Statement of the Committee of Conference, 106th Cong.2d.sess. (2000)] indicates that “the conferees intend that the GSP standard, including the provision with respect to implementation of obligations to eliminate the worst forms of child labor, apply to eligibility for those additional benefits” [provided for in the AGOA.]
Countries presently eligible under the GSP are: Afghanistan, Albania, Algeria, Angola, Anguilla, Antigua and Barbuda, Argentina, Armenia, Bahrain, Bangladesh, Barbados, Belize, Benin, Bhutan, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, British Virgin Islands, British Indian Ocean Territory, Bulgaria, Burkina Faso, Burundi, Cambodia, Cameroon, Cape Verde, Central African Republic, Chad, Christmas Islands, Cocos Islands, Colombia, Comoros, Republic of Congo, Democratic Republic of the Congo, Cook Islands, Costa Rica, Cote d'Ivoire, Croatia, Djibouti, Dominica, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Eritrea, Ethiopia, Falkland Islands, Fiji, Gabon, the Gambia, Georgia, Ghana, Gibraltar, Grenada, Guatemala, Guinea, Guinea-Bissau, Guyana, Haiti, Heard Island and MacDonald Islands, Honduras, India, Indonesia, Jamaica, Jordan, Kazakhstan, Kenya, Kiribati, Kyrgyzstan, Lebanon, Lesotho, Macedonia, Madagascar, Malawi, Mali, Mauritania, Mauritius, Moldova, Mongolia, Montserrat, Morocco, Mozambique, Namibia, Nepal, Niger, Nigeria, Niue, Norfolk Island, Oman, Pakistan, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Pitcairn Island, Romania, Russia, Rwanda, Saint Kitts and Nevis, Saint Lucia, Saint Vincent and the Grenadines, Samoa, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Solomon Islands, Somalia, South Africa, Sri Lanka, Suriname, Swaziland, Tanzania, Thailand, Togo, Tokelau Island, Tonga, Trinidad and Tobago, Tunisia, Turkey, Turks and Caicos Islands, Tuvalu, Uganda, Uruguay, Uzbekistan, Vanuatu, Venezuela, Wallis and Futuna, West Bank and Gaza Strip, Western Sahara, Republic of Yemen, Zambia, and Zimbabwe.
Countries eligible or potentially eligible for additional benefits under the AGOA include: Angola, Benin, Botswana, Cameroon, Cape Verde, Chad, Republic of Congo, Democratic Republic of the Congo, Cote d'Ivoire, Djibouti, Ethiopia, Gabon, the Gambia, Ghana, Guinea, Guinea Bissau, Kenya, Lesotho, Madagascar, Malawi, Mali, Mauritania, Mauritius, Mozambique, Namibia, Niger, Nigeria, Rwanda, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, South Africa, Swaziland, Tanzania, Uganda, and Zambia.
Countries potentially eligible for additional benefits under the CBTPA are: Barbados, Belize, Costa Rica, Dominican Republic, El Salvador, Guatemala, Guyana, Haiti, Honduras, Jamaica, Nicaragua, Panama, Saint Lucia, and Trinidad and Tobago.
The Department invites interested parties to submit written information relevant to the findings to be made by the Department of Labor under the TDA, for all listed countries. Information provided through public submission will be considered by the Department of Labor in preparing its findings. Materials submitted should be confined to the specific topic of the study. In particular, the Department's Bureau of International Labor Affairs is seeking written submissions on the following topics:
1. Whether the country has adequate laws and regulations proscribing the worst forms of child labor;
2. Whether the country has adequate laws and regulations for the implementation and enforcement of such laws and regulations;
3. Whether the country has established formal institutional mechanisms to investigate and address complaints relating to allegations of the worst forms of child labor;
4. Whether social programs exist in the country to prevent the engagement of children in the worst forms of child labor, and to assist in the removal of children engaged in the worst forms of child labor;
5. Whether the country has a comprehensive policy for the elimination of the worst forms of child labor;
6. Whether the country is making continual progress toward eliminating the worst forms of child labor.
Information relating to the nature and extent of child labor in the country is also sought.
The term “worst forms of child labor” is defined in section 412(b) of the TDA as comprising:
* * * (A) All forms of slavery or practices similar to slavery, such as the sale and trafficking of children, debt bondage and serfdom and forced or compulsory labor, including forced or compulsory recruitment of children for use in armed conflict;
(B) The use, procuring or offering of a child for prostitution, for the production of pornography or for pornographic performances;
(C) The use, procuring or offering of a child for illicit activities, in particular for the production and trafficking of drugs as defined in relevant international treaties; and
(D) Work which, by its nature or the circumstances in which it is carried out, is likely to harm the health, safety or morals of children. * * *
The TDA Conference Report noted that the phrase,
* * * Work which, by its nature or the circumstances in which it is carried out, is likely to harm the health, safety or morals of children * * *
The TDA Conference Report further indicated that this phrase be interpreted in a manner consistent with the intent of Article 4 of ILO Convention No. 182, which states that such work shall be determined by national laws or regulations or by the competent authority in the country involved.
This notice is a general solicitation of comments from the public.
Notice.
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) [44 U.S.C. 3506(c)(2)(A)]. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Employment Standards Administration is soliciting comments concerning the proposed collection: Office of Federal Contract Compliance Programs Complaint Form (CC-4). A copy of the proposed information collection request can be obtained by contacting the office listed below in the addresses section of this Notice.
Written comments must be submitted to the office listed in the addresses section below on or before September 13, 2004.
Ms. Hazel M. Bell, U.S. Department of Labor, 200 Constitution Ave., NW., Room S-3201, Washington, DC 20210, telephone (202) 693-0418, fax (202) 693-1451, E-mail
The Office of Federal Contract Compliance Programs (OFCCP) is responsible for the administration of three equal opportunity programs: Executive Order 11246, as amended; Section 503 of the Rehabilitation Act of 1973, as amended and 38 U.S.C. 4212, the Vietnam Era Veteran's Readjustment Assistance Act of 1974, as amended (VEVRAA). These programs require affirmative action by Federal contractors and subcontractors and prohibit discrimination on the basis of race, color, sex, religion, national origin, status as a qualified individual with disabilities or protected veteran. No private right of action exists under the three programs that are enforced by the U.S. Department of Labor (DOL),
The Department of Labor is particularly interested in comments which:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
The Department of Labor seeks the approval of the extension of this information in order to carry out its responsibility to enforce the affirmative action and anti-discrimination provisions of the three Acts, which it administers.
Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget approval of the information collection request; they will also become a matter of public record.
Notice.
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA 95) (44 U.S.C. 3506(c)(2)(A)). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and impact of collection requirements on respondents can be properly assessed. The Occupational Safety and Health Administration (OSHA) is soliciting comments concerning the proposed extension of approval for the current paperwork requirements of 29 CFR 1904, Recording and Reporting Occupational Injuries and Illnesses. A copy of the proposed information collection request can be obtained by contacting the office listed below in the address section of this notice.
Written comments must be submitted on or before September 13, 2004.
Written comments should:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;
• Evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Comments are to be submitted to the Docket Office, Docket No. ICR 1218-0176 2004 U.S. Department of Labor, Room N-2625, 200 Constitution Avenue, NW., Washington, DC 20210, telephone: (202) 693-2350. Written comments limited to 10 pages or less in length may also be transmitted by facsimile to (202) 693-1648.
Jacqueline Gilmore, Office of Statistical Analysis, Occupational Safety and Health Administration, U.S. Department of Labor, Room N3507, 200 Constitution Avenue, NW., Washington, DC 20210, telephone: (202) 693-1889. Copies of the referenced information collection request are available for inspection and copying in the Docket Office and will be mailed to persons who request copies by telephoning Jacqueline Gilmore at (202) 693-1889 or Todd Owen at (202) 693-3222. For electronic copies, contact OSHA's Web page on the Internet at
I.
The data also provides information to employers and employees of the kinds of injuries and illnesses occurring in the workplace and their related hazards. Increased employer awareness should result in the identification and voluntary correction of hazardous workplace conditions. Likewise, employees who are provided information on injuries and illnesses will be more likely to follow safe work practices and report workplace hazards. This would generally raise the overall level of safety and health in the workplace.
OSHA currently has approval from the Office of Management and Budget (OMB) for information collection requirements contained in 29 CFR 1904. That approval will expire on October 31, 2004, unless OSHA applies for an extension of the OMB approval. This notice initiates the process for OSHA to request an extension of the current OMB approval. This notice also solicits public comment on OSHA's existing paperwork burden estimates from those interested parties and to seek public response to several questions related to the development of OSHA's estimation. Interested parties are requested to review OSHA's estimates, which are based upon the most current data available, and to comment on their accuracy or appropriateness in today's workplace situation.
II.
Comments submitted in response to this notice will be summarized and/or
National Archives and Records Administration (NARA).
Notice.
NARA is giving public notice that the agency has submitted to OMB for approval the information collection described in this notice. The public is invited to comment on the proposed information collection pursuant to the Paperwork Reduction Act of 1995.
Written comments must be submitted to OMB at the address below on or before August 13, 2004 to be assured of consideration.
Comments should be electronically mailed to: OMB Desk Officer for NARA.
Requests for additional information or copies of the proposed information collection and supporting statement should be directed to Tamee Fechhelm at telephone number 301-837-1694 or fax number 301-837-3213.
Pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104-13), NARA invites the general public and other Federal agencies to comment on proposed information collections. NARA published a notice of proposed collection for this information collection on April 21, 2004 (69 FR 21584 and 21585). No comments were received. NARA has submitted the described information collection to OMB for approval.
In response to this notice, comments and suggestions should address one or more of the following points: (a) Whether the proposed information collection is necessary for the proper performance of the functions of NARA; (b) the accuracy of NARA's estimate of the burden of the proposed information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including the use of information technology. In this notice, NARA is soliciting comments concerning the following information collection:
Pursuant to the provisions of the Federal Advisory Committee Act (Public Law 92-463, as amended) notice is hereby given the National Council on the Humanities will meet in Washington, DC on July 29-30, 2004.
The purpose of the meeting is to advise the Chairman of the National Endowment for the Humanities with respect to policies, programs, and procedures for carrying out his functions, and to review applications for financial support from and gifts offered to the Endowment and to make recommendations thereon to the Chairman.
The meeting will be held in the Old Post Office Building, 1100 Pennsylvania Avenue, NW., Washington, DC. A portion of the morning and afternoon sessions on July 29-30, 2004, will not be open to the public pursuant to subsections (c)(4), (c)(6) and (c)(9)(B) of section 552b of title 5, United States Code because the Council will consider information that may disclose: Trade secrets and commercial or financial information obtained from a person and privileged or confidential; information of a personal nature the disclosure of which would constitute a clearly unwarranted invasion of personal privacy; and information the premature disclosure of which would be likely to significantly frustrate implementation of proposed agency action. I have made this determination under the authority granted me by the Chairman's Delegation of Authority dated July 19, 1993.
The agenda for the sessions on July 29, 2004, will be as follows:
(Open to the Public): Policy Discussion.
(Closed to the Public): Discussion of specific grant applications and programs before the Council.
The morning session on July 30, 2004, will convene at 9 a.m., in the 1st Floor Council Room M-09, and will be open to the public, as set out below. The agenda for the morning session will be as follows:
The remainder of the proposed meeting will be given to the consideration of specific applications and closed to the public for the reasons stated above.
Further information about this meeting can be obtained from Mr. Daniel C. Schneider, Advisory Committee Management Officer, National Endowment for the Humanities, 1100 Pennsylvania Avenue, NW., Washington, DC 20506, or by calling (202) 606-8322, TDD (202) 606-8282. Advance notice of any special needs or accommodations is appreciated.
National Indian Gaming Commission.
Notice of intent.
The notice advises the public that the National Indian Gaming Commission (NIGC), in cooperation with the Lytton Rancheria of California (“Lytton Rancheria”), intends to gather information necessary for preparing an Environmental Impact Statement (EIS) for a proposed casino project to be located in Contra Costa County, California. The purpose of the proposed action is to help address the socio-economic needs of the Lytton Rancheria. Details of the proposed action and location are provided below in the Supplemental Information section. The scoping process will include notifying the general public and federal, state, local, and tribal agencies of the proposed action. This notice also announces a public scoping meeting that will be held for the proposed action. The purpose of scoping is to identify public and agency concerns, and alternatives to be considered in the EIS.
Written comments on the scope of the EIS should arrive by August 16, 2004. The public hearing will be held on July 30, 2004, from 7 p.m. to 9 p.m., or until the last public comment is received.
Written comments on the scope of the EIS should be addressed to: Christine Nagle, NEPA Coordinator, National Indian Gaming Commission, 1441 L Street NW., 9th Floor, Washington, DC 20005, telephone (202) 632-7003. Please include your name, return address, and the caption: “DEIS Scoping Comments, Lytton Rancheria Casino Project”, on the first page of your written comments.
The public hearing will be co-hosted by the NIGC and the Lytton Rancheria. The meeting location is Maple Hall, 13831 San Pablo Avenue, Building #4, San Pablo, CA 94806.
For general information on NEPA review procedures or status of the NEPA review, contact Christine Nagle, NIGC NEPA Coordinator, 202-632-7003.
The proposed federal action is the approval of a gaming management contract between the Lytton Rancheria and California Indian Gaming Management, LLC (“CIGM”). The approval of the gaming management contract would result in the development of a casino and supporting facilities. The facility will be managed by CIGM on behalf of the Lytton Rancheria, pursuant to the terms of a gaming management contract. The proposed development would take place on an approximately 9.5 acre site (the project site) that is held in trust by the United States for the benefit of the Lytton Rancheria. The project site is located in the City of San Pablo in Contra Costa County, and within one mile of Interstate 80. Surrounding land uses are urban, and include a hospital, offices, restaurants, and retail. In addition to the proposed action, a reasonable range of alternatives, including a no action alternative will be analyzed in the EIS.
The Lytton Rancheria consists of approximately 259 members. It is governed by a tribal council, consisting of seven members, under a constitution that was passed by vote of the members on August 30, 1996.
The NIGC will serve as lead agency for compliance with the National Environmental Policy Act (NEPA).
Individual commenters may request confidentiality. If you wish us to withhold your name and/or address from public review or from disclosure under the Freedom of Information Act, you must state this prominently at the beginning of your written comment. Such requests will be honored to the extent allowed by law. Anonymous comments will not, however, be considered. All submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, will be made available for public inspection in their entirety.
This notice is published pursuant to Sec. 1503.1 of the Council of Environmental Quality Regulations (40 CFR, Part 1500 through 1508 implementing the procedural requirements of the NEPA of 1969, as amended (42 U.S.C. 4371
National Science Foundation.
Submission for OMB review; comment request.
The National Science Foundation (NSF) has submitted the following information collection requirement to OMB for review and clearance under the Paperwork Reduction Act of 1995, Pub. L. 104-13. This is the second notice for public comment; the first was published in the
NSF may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
This document has been prepared to support the clearance of data collection instruments to be used in the evaluation of the Math and Science Partnership (MSP) Program. The goals for the program are to (1) ensure that all K-12 students have access to, are prepared for, and are encouraged to participate and succeed in challenging curricula and advanced mathematics and science courses; (2) enhance the quality, quantity, and diversity of the K-12 mathematics and science teacher workforce; and (3) develop evidence-based outcomes that contribute to our understanding of how students effectively learn mathematics and science. The motivational force for realizing these goals is the formation of partnerships between institutions of higher education (IHEs) and K-12 school districts. The role of IHE content faculty is the cornerstone of this intervention. In fact, it is the rigorous involvement of science, mathematics, and engineering faculty—and the expectation that both IHEs and K-12 school systems will be transformed—that distinguishes MSP from other education reform efforts.
The components of the overall MSP portfolio include active projects whose initial awards were made in prior MSP competitions, as well as those to be awarded in the current MSP competition: (1) Comprehensive Partnerships that implement change in mathematics and/or science educational practices in both higher education institutions and in schools and school districts, resulting in improved student achievement across the K-12 continuum; (2) Targeted Partnerships that focus on improved K-12 student achievement in a narrower grade range or disciplinary focus within mathematics or science; (3) Institute Partnerships: Teacher Institutes for the 21st Century that focus on the development of mathematics and science teachers as school- and district-based intellectual leaders and master teachers; and (4) Research, Evaluation and Technical Assistance (RETA) projects that build and enhance largescale research and evaluation capacity for all MSP awardees and provide them with tools and assistance in the implementation and evaluation of their work.
The MSP online monitoring system, comprised of four web-based surveys, will collect a common core of data about each component of MSP. The web application for MSP will be developed with a modular design that incorporates templates and self-contained code modules for rapid development and ease of modification. A downloadable version will also be available for respondents who prefer a paper version that they can mail or fax to Westat. Information from the system will be used to document the Partnerships' annual progress toward meeting the Key features of MSP projects, such as developing partnerships between IHEs and local school districts, increasing teacher quality, quantity, and diversity, providing challenging courses and curricula, utilizing evidence-based design and outcome measures, and implementing institutional change and sustainability.
The expected respondents are principal investigators of all projects; STEM and education faculty members and administrators who participated in MSP; school districts and IHEs that are partners in an MSP project.
During the first year of data collection, Cohort 1 projects will be asked to report baseline data (
July 16, 2004 11:30 a.m.-12:30 p.m. Closed Session.
The National Science Foundation, Stafford One Building, 4201 Wilson Boulevard, Arlington, VA 22230.
This meeting will be closed to the public.
Friday, July 16, 2004.
The National Science Board Committee on Strategy and Budget will discuss the NSF FY 2006 budget request.
John Wilkinson, Executive Secretary, CSB, (703) 292-7000,
Pursuant to delegation by the Commission dated December 29, 1972, published in the
As specified in the Commission's July 7, 2004 order (CLI-04-20, 60 NRC at _
The Board is comprised of the following administrative judges:
All correspondence, documents, and other materials shall be filed with the administrative judges in accordance with 10 CFR 2.1010(d).
Nuclear Regulatory Commission.
Notice of Availability of Environmental Assessment and Finding of No Significant Impact.
John D. Kinneman, Nuclear Materials Safety Branch 2, Division of Nuclear Materials Safety, Region I, 475 Allendale Road, King of Prussia, Pennsylvania 19406, telephone (610) 337-5252, fax (610) 337-5269; or by e-mail:
The Nuclear Regulatory Commission (NRC) is considering issuing a license amendment to the U.S. Department of the Army (Army) for Materials License No. 19-01151-02, to terminate the license and authorize release of its facilities at the U.S. Army Garrison in Fort Detrick, Frederick County, Maryland for unrestricted use. NRC has prepared an Environmental Assessment (EA) in support of this action in accordance with the requirements of 10 CFR part 51. Based on the EA, the NRC has concluded that a Finding of No Significant Impact (FONSI) is appropriate. The Army's request for the proposed action was previously noticed in the
The purpose of the proposed action is to terminate Byproduct Materials License No. 19-01151-02 and release the licensee's Fort Detrick facility for unrestricted use. The Army was authorized by NRC since 1954 to use radioactive materials for research and development purposes and for collection, storage, and disposal of radioactive wastes from tenant facilities at the site. On March 26, 2004, the Army provided the results of the final task in the decommissioning of the facility and requested that NRC release the Fort Detrick facility for unrestricted use. The Army has conducted surveys of the Fort Detrick facility and determined that the facility meets the license termination criteria in subpart E of 10 CFR part 20. The NRC staff has prepared an EA in support of the proposed license amendment.
The staff has prepared the EA (summarized above) in support of the proposed license amendment to terminate the license and release the facility for unrestricted use. The NRC staff has evaluated the Army's request and the results of the surveys and has concluded that the completed action complies with the criteria in subpart E of 10 CFR part 20. The staff has found that the environmental impacts from the proposed action are bounded by the impacts evaluated by the “Generic Environmental Impact Statement in Support of Rulemaking on Radiological Criteria for License Termination of NRC-Licensed Facilities” (NUREG-1496). The staff has also found that the non-radiological impacts are not significant. On the basis of the EA, the NRC has concluded that the environmental impacts from the proposed action are expected to be insignificant and has determined not to prepare an environmental impact statement for the proposed action.
The EA and the documents related to this proposed action, including the application for the license amendment and supporting documentation, are available for inspection at NRC's Public Electronic Reading Room at
For the Nuclear Regulatory Commission.
The Advisory Committee on Nuclear Waste (ACNW) will hold its 152nd meeting on July 20-22, 2004, Room T-2B3, 11545 Rockville Pike, Rockville, Maryland.
The entire meeting will be open to public attendance except for portions that will be closed to discuss organizational and personnel matters that relate solely to internal personnel rules and practices of the ACNW; information the release of which would constitute a clearly unwarranted invasion of personal privacy; and information the premature disclosure of which would be likely to significantly frustrate implementation of a proposed
The schedule for this meeting is as follows:
This session may be closed pursuant to 5 U.S.C. 552b (c) (2), (6) and (9) (B) to discuss organizational and personnel matters that relate solely to internal personnel rules and practices of the ACNW; information the release of which would constitute a clearly unwarranted invasion of personal privacy; and information the premature disclosure of which would be likely to significantly frustrate implementation of a proposed agency action.]
Procedures for the conduct of and participation in ACNW meetings were published in the
In accordance with subsection 10(d) Pub. L. 92-463, I have determined that it is necessary to close portions of this meeting noted above to discuss organizational and personnel matters that relate solely to internal personnel rules and practices of the ACNW; information the release of which would constitute a clearly unwarranted invasion of personal privacy; and information the premature disclosure of which would be likely to significantly frustrate implementation of a proposed
Further information regarding topics to be discussed, whether the meeting has been canceled or rescheduled, the Chairman's ruling on requests for the opportunity to present oral statements and the time allotted therefore can be obtained by contacting Mr. Howard J. Larson.
ACNW meeting agenda, meeting transcripts, and letter reports are available through the NRC Public Document Room at
Videoteleconferencing service is available for observing open sessions of ACNW meetings. Those wishing to use this service for observing ACNW meetings should contact Mr. Theron Brown, ACNW Audiovisual Technician (301/415-8066), between 7:30 a.m. and 3:45 p.m. e.t., at least 10 days before the meeting to ensure the availability of this service. Individuals or organizations requesting this service will be responsible for telephone line charges and for providing the equipment and facilities that they use to establish the video teleconferencing link. The availability of video teleconferencing services is not guaranteed.
Postal Service.
Notice of new system of records.
The Postal Service proposes a new Privacy Act system of records. The system of records will apply to a name and address directory that the Postal Service plans to license from a commercial source, in order to improve the proper barcoding and delivery of mail.
Any interested party may submit written comments on the proposed system of records. This proposal will become effective without further notice on August 23, 2004, unless comments received on or before that date result in a contrary determination.
Please address your comments to the Privacy Office, United States Postal Service, 475 L’ Enfant Plaza, SW, Room 10433, Washington, DC 20260-2200. Copies of all written comments will be available at this address for public inspection and photocopying between 8 a.m. and 4 p.m., Monday through Friday.
Privacy Office, United States Postal Service, Room 10433, Washington, DC 20260-2200. Phone: 202-268-5959.
This document publishes notice of a new system of records for the Postal Service, USPS 500.100, Address Matching for Mail Processing. The new system of records supports a Postal Service program, called the Distribution Quality Improvement (DQI) Program, which will use a commercially available name and address directory to improve mail processing. The purpose of the DQI program is to increase the ability of the Postal Service to barcode mail properly in order to ensure delivery to the intended address. The Postal Service plans to pilot test the program in New York State from September 2004 to Spring 2005, then, if successful, deploy the program nationally in or after May 2005.
Described below are: (I) The need for and benefits of the DQI program; (II) how the pilot test and national deployment will be conducted; and (III) the extensive privacy and security controls that have been put in place, including how the directory will and will not be used. The Postal Service does not anticipate adverse effects on the privacy rights of customers resulting from operation of the DQI program.
Mail has always been one of the most valuable, effective, and trusted means of communication. For more than two centuries, the mission of the Postal Service has been the prompt, reliable, and efficient delivery of personal and business mail to all communities in the nation. As the delivery network has developed and expanded, the Postal Service has continuously adapted every major innovation in technology, transportation, and communication to provide enhanced service to its customers. From the early transportation improvements provided by railway Post Offices, to today's technology applications such as USPS.com, the Postal Service has a long history of pursuing continual improvements to the speed, accuracy, and certainty of mail delivery.
Today, the Postal Service delivers more than 200 billion pieces of mail each year to more than 140 million addresses, serving every household and business in the country. Every year, approximately 1.9 million addresses—equivalent in size to the city of Chicago—are added to the delivery network. In order to accomplish its mission of universal service, the Postal Service operates some of the most complex systems and equipment ever developed. The Postal Service delivers more mail to more locations, and at a lower price, than any other post or delivery network in the world.
The privacy and security of mail are also at the core of the Postal Service brand. Over the course of its history, the Postal Service has built a trusted brand with the public. New technology and processes continue to be developed that bring added value and customer service to the network. As always, the Postal Service will only use technology, or adapt that technology, in a way that ensures that the privacy and security of the mail and its customers are maintained at the highest levels. The current proposal is no exception. The Postal Service has carefully analyzed the need, usage, and benefits of the DQI program, while establishing procedures that would properly address privacy and security needs.
In order to ensure that the billions of mailpieces it processes are delivered accurately, promptly, and cost effectively, the Postal Service has developed a sophisticated network and state-of-the-art systems to process mail. This section describes the information the Postal Service uses, including databases, ZIP Codes
To facilitate accurate delivery, the Postal Service maintains a database of addresses known as the USPS Address Management System (AMS). AMS contains valid addresses that receive postal delivery. For each address, the AMS database includes the following elements: carrier number; ZIP Code; city and state; street name; primary address (such as house number); and secondary address information (such as apartment or suite number), if applicable. Names of large firms are included. Names of individuals are not included, except for
As first developed and as used today, AMS supports mail processing by enabling the Postal Service to barcode mail that does not have a barcode printed on it by the mailer. The mail can then be processed on automated sorting equipment rather than by manual or mechanized operations. Automation improves the efficiency, accuracy, and timeliness of mail processing and delivery.
The process works as follows: To ensure that mail contains a valid address for delivery, the automation equipment first reads the address on the piece and matches it to the AMS database. The equipment then generates and prints a barcode on the mailpiece which contains the ZIP Code associated with that address. The ZIP Code printed may be 5, 9, or 11 digits, as described below, depending on the level of match to AMS. The goal is to print the most complete ZIP Code, a code known as the finest depth of sort (FDOS). The FDOS ZIP Code is a code that represents the most specific delivery point available for a particular address. Examples are a single house or an apartment/suite in a building. When coded to FDOS, mail can be sorted without any manual intervention directly into the sequence in which a letter carrier delivers mail (known as a walk sequence).
The Postal Service assigns ZIP Codes as follows. The familiar 5-digit ZIP Code describes a geographical area, such as a small town or section of a larger town. The ZIP+4 code, a 9-digit ZIP Code, describes a much more specific location, often a particular block on a street of single family houses, or a particular apartment building in a more densely populated area. The Postal Service also uses an 11-digit code, which adds two more digits of specificity. FDOS is generally 11 digits, but can be 9 digits (in the case of reply mail for certain businesses) or very rarely 5 digits, where a very large mail recipient has its own unique ZIP Code. Buildings that contain multiple deliveries are typically assigned a 9 digit code. If the mailpiece being processed contains sufficient information, such as an apartment number, the Postal Service is able to match the piece against AMS and print an 11 digit FDOS ZIP Code to the specific address. If the mailpiece has missing or incorrect elements, the 11 digit barcode printed on the piece will simply include a default value for the building, so it is not coded to FDOS.
Without a match to AMS that allows an FDOS ZIP Code, the Postal Service cannot be certain of the exact address for delivery. Minor discrepancies, such as a single missing, mistaken, or illegible character, can modify the address enough to prevent FDOS matching. As described below, the Postal Service then has to take significant additional steps to handle the mailpiece, and there is a greater likelihood the mail will be delayed or not delivered to the intended address.
Described below is an overview of the systems used to process letters. Particular focus is given to address recognition systems, where the DQI program will be implemented.
Each year, the Postal Service processes more than 147 billion letters. These mailpieces enter the postal system in one of two ways. Approximately 102 billion pieces come in through acceptance units from business mailers, and are typically presorted and/or barcoded. This mail is sorted on automation equipment known as barcode sorters, and does not require processing on address recognition systems. The remainder, approximately 45 billion pieces, enters through collection systems such as collection boxes and local Post Offices
1. When collection letter mail is processed, automation equipment sends an image of the mailpiece to a recognition system known as a remote computer reader (RCR). RCR is a completely computer-based system that requires no human intervention to perform address matching. Pieces already barcoded are sent to the barcode sorters. For nonbarcoded pieces, the RCR system attempts to match the address in the image to an address in the AMS database. If it completes a match to a sufficient level of confidence, a barcode is printed on the mailpiece, and the piece is routed using the barcode. If RCR cannot match the address, the image is sent offsite to a recognition system known as a Remote Encoding Center (REC).
2. At REC sites, employees review the image and key in information from the mailpiece in an attempt to match the address to AMS. If the address is matched, a barcode is printed on the mailpiece, and the piece is processed using the barcode. If there is no match, the piece must be sorted manually.
3. Manual processing is conducted at several places and levels, including originating and destinating Postal Service facilities, as the Postal Service tries to route the mailpiece for delivery to the intended address. Employees performing manual processing use various sources to recognize the address on the mailpiece. These sources can include internal information, such as derivations of AMS, as well as external information including phone books and maps. From these sources, the mailpiece is sorted to the best estimate of the correct letter carrier route. The letter carrier will then attempt further sorting and delivery. If the address cannot be recognized as one of the carrier's delivery addresses, it will go through further processing to find the right address. If all efforts are unsuccessful, the mailpiece is determined to be undeliverable as addressed. Undeliverable mail is reviewed for final processing, either to be forwarded, returned to the sender, or discarded, depending on the class of mail and level of service requested by the mailer.
4. Once barcoded, mail is sorted through automation into the walk sequence used by letter carriers to complete their routes. If processed manually, the letter carrier sorts the mail into the walk sequence at the local delivery facility. Through either process, when carriers identify errors based on their personal knowledge, they attempt to reroute the mailpiece to the correct address.
Each additional step in address recognition increases the time, resources, and costs required for delivery, and the possibility that the mail will not be delivered correctly.
Since the Postal Service introduced address recognition systems in the 1980s, their performance has continuously improved. For example, the ability of RCRs to read and match addresses has improved dramatically. From 1996 to 2004, RCR performance has improved from 35% to 90%. This has reduced the need for REC image processing from a peak of 24 billion to around 6 billion images per year. The error rate, where mail is coded improperly, has also been reduced.
To date, the Postal Service has focused on improvements that could be accomplished by technology, such as improvements in reading characters in the address. The Postal Service has been very successful in these efforts, but is now nearing the limits of technological
The goal of the Postal Service in implementing the Distribution Quality Improvement (DQI) program is to improve its ability to barcode mail that is not already barcoded by the mailer, and deliver it to the correct address. The Postal Service plans to pilot test the program in New York. The purpose of the test is to evaluate the level of improvement achieved through the DQI program. If the test is successful, the program will be deployed nationally. Described below are how the pilot test will be conducted (including pilot sites), estimated benefits, and national deployment.
To conduct the pilot test, the Postal Service will license a name and address directory from a commercial vendor. The directory will be a commercial directory that is currently available in the marketplace. The vendor will serve as a subcontractor to an existing Postal Service contractor tasked in part to help improve recognition rates. Neither the Postal Service nor its contractor will own the commercial directory.
The commercial directory will be maintained in a secure location, at a contractor site during the pilot test, and at a Postal Service site during any national deployment. At this maintenance site, before the directory is deployed to the field, every address in the directory will be compared with the AMS database. Using AMS to screen the directory before activation ensures that only valid addresses will be used and that the directory will be compatible with postal operations and mail processing. In order to assure accuracy, this process will be repeated on a weekly basis to conform to the most recent AMS database. The removal of invalid addresses will be the only result of this procedure—no additions or any other modification will be made to the directory used in the DQI program. Also, no data in the AMS database or other Postal Service databases will be modified in any way through use of the commercial directory.
After this screening, the commercial directory will be installed on RCR systems in field processing centers. Once installed, software on the RCR system will perform the following steps:
1. RCR first compares the address from the mailpiece with the AMS database, looking for a match to FDOS coding. If there is an FDOS match to a sufficient level of confidence, the mail will be processed without use of the commercial directory.
2. If unable to perform such a match, RCR will use the commercial directory to try to find the right address. RCR will use the results of the insufficient AMS match to retrieve a set of potential name(s) and delivery points from the commercial name and address databases. RCR then compares the names with the name on the mailpiece, seeking a match.
3. If the name and address on the mailpiece match a name and FDOS address from the commercial directory to a sufficient level of confidence, then the address verification process is complete. Thereafter, the process is the same as without the directory. An FDOS barcode is generated and applied using the identical processes for mail coded by RCR.
4. If a match is not found with the commercial directory, the result from the initial AMS match will be used, and the mailpiece will be processed using existing systems without DQI.
The following is a hypothetical example of how the DQI program will work: Mr. John Doe lives at 123 Main Street S. There is also a 123 Main Street N in that city. The Postal Service receives a nonbarcoded mailpiece addressed to Mr. John Doe, 123 Main Street. When the piece is processed against AMS, the Postal Service cannot tell whether the right address is 123 Main Street North or South. Under current processes, the Postal Service will attempt to discover the right address through other internal or external tools, or through personal knowledge of letter carriers, and there is a risk the piece may be routed or delivered incorrectly. With the DQI program, when the AMS match fails to produce an FDOS result, the Postal Service can confirm a Mr. John Doe lives at 123 Main Street S, and can barcode and deliver the piece to that address.
The sole purpose of the use of names in the DQI program is to confirm delivery to the correct address. The DQI program and directory will not be used for any purpose other than improving the barcoding of mail that is not being recognized to an FDOS ZIP Code by existing systems. DQI will not modify any written or printed address information on the mailpiece. No changes will be made to the AMS database or any other Postal Service database as a result of this process, nor will any information be provided back to the commercial vendor or directory, including which addresses have been removed.
The pilot test of the DQI program will apply to mail that is processed by postal stations serving New York State. The commercial directory will contain only the names and addresses of individuals and firms residing in New York. The directory will be installed on an RCR system in a processing plant in Manhattan. Mail originating from the processing plant and destinating in the State of New York will be subject to DQI processing. During the pilot test, the only mail eligible for the DQI program will be mailpieces with machine-printed addresses.
New York was chosen because of the size and complexity of the New York City area. The New York City area is not only one of the largest in the United States, but also one of the most densely populated, with a population of more than 7.4 million people and a total area over 300 square miles. It typifies areas that experience a higher rate of mailpieces with unrecognized addresses. Greater rates of unrecognized addresses are found in urban areas with densely populated high-rise apartments, concentrations of small business firms, street names with numeric or single characters, and street names with directionals (
The goal of the Postal Service is to deliver mail accurately and securely to a specific address. For mail that is not barcoded, the Postal Service attempts to recognize and barcode the mail so it gets to the right address as efficiently as
In 2003, the Postal Service processed more than 45 billion letters through its address recognition systems. With the DQI program, the Postal Service expects to properly code at least a billion more mailpieces than it can under current processes, as well as reduce the rate of miscoding.
Proper barcoding increases the certainty that mail will be delivered to the correct and intended address. This decreases the likelihood of misdelivered mail, which protects the privacy of Postal Service customers. By developing and implementing substantial safeguards, the Postal Service seeks to improve mail delivery and privacy for its customers, while minimizing privacy risks or vulnerabilities.
The pilot test is planned to start in September 2004 and conclude in the Spring of 2005. The Postal Service will thoroughly analyze results from the pilot test for operational accuracy and performance improvements. The test will be considered successful if it raises the encoding rate while reducing the error rate. If the expected improvements are achieved, the Postal Service plans to deploy the DQI program in other regions or nationally in or after May 2005.
If the pilot is successful, national deployment will occur in several stages. First, the program will become national in scope. The directory licensed will include names and addresses of firms and individuals throughout the country, and will be deployed to RCRs nationally. Second, DQI will be expanded from letters to other types of mail, including flats and parcels, so the directory will be installed on recognition equipment for those mail types. Third, the directory may be used on more levels of recognition equipment, not just the initial readers. An example is deployment at the Remote Encoding Centers. As deployment proceeds, the Postal Service will carefully evaluate the success of each stage, and will monitor privacy and system safeguards.
The Postal Service has established a comprehensive system of safeguards to protect the privacy and security of the DQI Program and commercial directory. The following describes key aspects of the Privacy Act system, including controls and limitations over the directory, security controls and safeguards, and limitations on external disclosures. The notice of the system of records covers both the pilot test and any national deployment.
The commercial directory will be used only for the purposes described in this notice and not for any other purpose. The directory will only be used to properly recognize and code mail if it cannot be successfully recognized to FDOS by existing systems.
The Postal Service has limited the type of information that will be licensed from the commercial source to the minimum necessary to achieve its operational goals. The only information contained in the commercial directory are the names and addresses of individuals and businesses.
The Postal Service has established strict controls to limit how data will be compared or shared between the commercial directory and Postal Service systems. There will be limited interfaces between the directory and Postal Service databases. At the maintenance site, the directory will be matched against the AMS database to remove invalid addresses before deployment. During mail processing, mailpieces will be matched against the directory if the match to AMS is less than to FDOS. No data will be exchanged as a result of these comparisons. The directory will not be used for updating AMS or any other Postal Service database. Likewise, no name or address information from any Postal Service database, including information about items removed from the directory, will be provided back to the commercial directory or vendor.
The Postal Service will implement the DQI program in a secure fashion. The commercial vendor will supply the directory to the contractor during the pilot test, and to the Postal Service during any national deployment, where it will be kept in a secure maintenance facility. Access to information in the directory will be limited to the following circumstances and purposes: At the maintenance facility, the Postal Service or contractor will access the directory to remove non-AMS data as described above, as well as to allow the Postal Service to respond to requests by individuals for access to information maintained about them as required by the Privacy Act. The Postal Service will also access the directory in its Engineering Headquarters facility in order to test the success of the program. The maintenance and engineering facilities are the only two locations where information contained in the directory can be accessed by Postal Service or contractor employees.
When the directory is distributed to Postal Service field sites, both name and address information will be encrypted. There will be no ability to view, query, or modify records in the directory. At all times, the directory will be stored in a separate file from Postal Service databases. In addition, the directory's name information will be stored in a separate file from its address information.
The directory will only operate on secure systems. Electronic transmissions of updates to the directory will be protected by encryption and secure access authorization codes.
To keep information current as well as secure, the Postal Service will receive an updated commercial directory periodically, no less frequently than every 90 days. The Postal Service will match the directory against the AMS database every week to remove invalid addresses. The Postal Service will maintain two versions of the directory representing 2 weeks of data—the directory for the current week, and the directory for the prior week. Every week, when the next directory is created, the Postal Service will destroy the older version in accordance with its information security policies. The policies require degaussing for computer tapes, using zero-bit formatting for computer hard drives, and physically destroying floppy disks, CDs, and DVD data disks. After these procedures are conducted, previous versions will not be retained in any form.
The Postal Service does not anticipate adverse privacy effects resulting from Postal Service disclosures of information from the commercial directory. First, such information is commercially available. Any entity can obtain information contained in the directory from the commercial source. Second, the Postal Service has limited the external disclosures, or routine uses, of information from the directory.
For this system of records, the Postal Service will only employ seven of the
The Postal Service has also added a special routine use for this system. The routine use applies when a mailpiece containing a barcode applied using the commercial directory is returned to the mailer. This may occur if the mailpiece is still not delivered to an address after all Postal Service efforts have been exhausted—for instance, if the person does not live at that address—and the mailer is entitled to return service because the mailpiece was sent First-Class Mail® or the mailer otherwise paid for return service. If the mailer has access to the Postal Service ZIP+4 database and is familiar with Postal Service rules and algorithms for FDOS coding, the mailer may be able to determine the specific FDOS ZIP Code from the barcode. The Postal Service ZIP+4 database and rules for coding are available to mailers for a fee. ZIP Code information, including ZIP+4 codes and FDOS ZIP Codes for houses, is also available as part of the ZIP Code lookup Web site available on
The Postal Service considers that disclosure of a barcode that contains a ZIP Code for an address may not be a disclosure under the Privacy Act. However, in the interests of full notice and transparency, the Postal Service is issuing a routine use to account for this occurrence. The Postal Service considers this an appropriate routine use because the Postal Service must honor return service requests. Moreover, the Postal Service considers the value of the information to be minimal in this circumstance, and the likelihood of such decoding to be remote. The information, which is a specific address, not name, is likely to be incorrect, since the mailpiece could not be delivered as addressed. Also, the mailer would need to train personnel to identify DQI mailpieces, and set up processes or equipment to conduct the algorithms needed to extract the address from the barcode. These processes are not technically practical, and are likely more costly than purchasing the same information directly from one of several available commercial sources.
The system of records described by this notice entails a third-party source, as the Postal Service has determined that obtaining this information directly from the subject individuals is not practical. However, the information collected from the third-party source for this system shall in no case result in any adverse determination to individuals. The Postal Service will ensure that the third-party source is informed of the purposes for which the name and address records will be used. This is consistent with OMB Guidelines and Privacy Protection Study Commission recommendations related to 5 U.S.C. 552a (e)(3).
The Postal Service seeks to improve the accuracy and certainty of mail delivery. The Postal Service has developed a very sophisticated network and equipment to accomplish this result. Based on its extensive experience, the Postal Service considers that use of a commercially available name and address database, such as proposed for the DQI program, is the best method to achieve higher barcoding rates and more certain delivery. The Postal Service proposes use of the directory for this sole purpose, and has established effective safeguards to protect the information and prevent any other use.
Address Matching for Mail Processing.
Computer Operations Service Center; Engineering; Processing and Distribution Centers; and contractor site(s).
USPS customers, including individual and business customers.
Names and mailing addresses of individuals and businesses.
39 U.S.C. 401, 403, 404.
To improve the speed, accuracy, and certainty of mail delivery.
The standard routine uses for customer-related systems apply, except that routine uses 3 and 6 do not apply. The following additional routine use also applies:
A mailpiece containing a barcode that is encoded with the address, but not name, of a customer derived from this system may be disclosed to a mailer if the Postal Service is unable to deliver the mailpiece, and returns it to the mailer as part of a requested return service.
Automated databases, electronic and computer storage media, with names and addresses stored separately.
Retrieval is accomplished by a computer-based system, using one or more of the following elements: name, ZIP Code(s), street name, primary number, secondary number, delivery point, and/or carrier route identification.
The name and address database will be obtained from a commercial vendor under strict contract and security controls. The database will be maintained separately from Postal Service databases. Name data and address data within the commercial database will also be stored separate from each other. In field deployment, name and address data will be stored in an encrypted fashion. The database will not be commingled with any agency records or databases, and will not be used to update any agency record or database. No information will be provided from the Postal Service into the commercial database or back to the vendor.
The database will only operate on secure systems. Electronic transmissions of records are protected by encryption and access authorization codes. Records are kept on computers in controlled-access areas, with access limited to
The database will be maintained until 90 days after termination of the contract or program, and then destroyed. During contract performance, the database will be replaced by the vendor in its entirety no less frequently than every 90 days. To destroy the replaced version, the Postal Service will employ sanitization procedures that will ensure the complete destruction of information as specified by its information security policies.
Senior Vice President for Operations, United States Postal Service, 475 L'Enfant, Plaza, SW., Washington, DC 20260.
Customers wanting to know if information about them is kept in this system of records should address inquiries in writing to the Manager, Image Recognition Processing, 8403 Lee Highway, Merrifield VA 22082.
Requests for access must be made in accordance with the Notification Procedure above and the Postal Service Privacy Act regulations regarding access to records and verification of identity under 39 CFR 266.6.
See Notification Procedure and Record Access Procedures above.
Commercially available source of names and mailing addresses.
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995,
The Securities Exchange Act of 1934 (“Act”) sets forth a regulatory scheme for national securities exchanges. Rule 6a-1 under the Act
The respondents to the collection of information are entities that seek registration as a national securities exchange or that seek exemption from registration based on limited trading volume. After the initial filing of Form 1, both registered and exempt exchanges are subject to ongoing informational requirements.
Initial filings on Form 1 by new exchanges are made on a one-time basis. The Commission estimates that it will receive approximately three initial Form 1 filings per year and that each respondent would incur an average burden of 47 hours to file an initial Form 1 at an average cost per response of approximately $4517. Therefore, the Commission estimates that the annual burden for all respondents to file the initial Form 1 would be 141 hours (one response/respondent × three respondents × 47 hours/response) and $13,551 (one response/respondent × three respondents × $4517/response).
There currently are nine entities registered as national securities exchanges and two exempt exchanges. The Commission estimates that each registered or exempt exchange files one amendment or periodic update to Form 1 per year, incurring an average burden of 25 hours to comply with Rule 6a-2. The Commission estimates that the annual burden for all respondents to file amendments and periodic updates to the Form 1 pursuant to Rule 6a-2 is 275 hours (11 respondents × 25 hours/response × one response/respondent per year) and $25,630 (11 respondents × $2330/response × one response/respondent per year).
Compliance with Rules 6a-1 and 6a-2 and Form 1 is mandatory for entities seeking to register as a national securities exchange or seeking an exemption from registration based on limited trading volume. Information received in response to Rules 6a-1 and 6a-2 and Form 1 shall not be kept confidential; the information collected is public information. As set forth in Rule 17a-1 under the Act,
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid control number.
Written comments regarding the above information should be directed to the following persons: (a) Desk Officer for the Securities and Exchange Commission by sending an e-mail to:
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995,
Section 6 of the Securities Exchange Act of 1934 (“Act”)
The respondents to the collection of information are national securities exchanges and exchanges that are exempt from registration based on limited trading volume.
The Commission estimates that each respondent makes approximately 25 such filings on an annual basis at an average cost of approximately $21 per response. Currently, 11 respondents (nine national securities exchanges and two exempt exchanges) are subject to the collection of information requirements of Rule 6a-3. The Commission estimates that the total burden for all respondents is 137.5 hours (25 filings/respondent per year × 0.5 hours/filing × 11 respondents) and $5775 ($21/response × 25 responses/respondent per year × 11 respondents) per year.
Compliance with Rule 6a-3 is mandatory for registered and exempt exchanges. Information received in response to Rule 6a-3 shall not be kept confidential; the information collected is public information. As set forth in Rule 17a-1 under the Act,
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid control number.
Written comments regarding the above information should be directed to the following persons: (a) Desk Officer for the Securities and Exchange Commission by sending an e-mail to:
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Form N-5—Registration Statement of Small Business Investment Companies Under the Securities Act of 1933 and the Investment Company Act of 1940. Form N-5 is the integrated registration statement form adopted by the Commission for use by a small business investment company which has been licensed as such under the Small Business Investment Act of 1958 and has been notified by the Small Business Administration that the company may submit a license application, to register its securities under the Securities Act of 1933 [15 U.S.C. 77a
General comments regarding the above information should be directed to the following persons: (i) Desk Officer for the Securities and Exchange Commission, Office of Information and Regulatory Affairs, Office of Management and Budget, Room 10102, New Executive Office Building, Washington, DC 20503, or e-mail to:
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Form N-8A—Notification of Registration of Investment Companies. Form N-8A [17 CFR 274.10] is the form that investment companies file to notify the Commission of the existence of active investment companies. After an investment company has filed its notification of registration under section 8(a) of the Investment Company Act of 1940 [15 U.S.C. 80a-1
The Commission uses the information provided in the notification on Form N-8A to determine the existence of active investment companies and to enable the Commission to administer the provisions of the 1940 Act with respect to those companies. Each year approximately 263 investment companies file a notification on Form N-8A, which is required to be filed only once by an investment company. The Commission estimates that preparing Form N-8A requires an investment company to spend approximately 1 hour so that the total burden of preparing Form N-8A for all affected investment companies is 263 hours. Estimates of average burden hours are made solely for the purposes of the Paperwork Reduction Act, and are not derived from a comprehensive or even a representative survey or study of the costs of Commission rules and forms.
The collection of information on Form N-8A is mandatory. The information provided on Form N-8A is not kept confidential. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
General comments regarding the above information should be directed to the following persons: (i) Desk Officer for the Securities and Exchange Commission, Office of Information and Regulatory Affairs, Office of Management and Budget, Room 10102, New Executive Office Building, Washington, DC 20503, or email to:
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Form N-8B-2—Registration Statement of Unit Investment Trusts that are Currently Issuing Securities.
Form N-8B-2 is the form used by unit investment trusts (“UITs”) that are currently issuing securities, including UITs that are issuers of periodic payment plan certificates and UITs of which a management investment company is the sponsor or depositor, to comply with the filing and disclosure requirements imposed by section 8(b) of the Investment Company Act of 1940 [15 U.S.C. 80a-8(b)]. Form N-8B-2 requires disclosure about the organization of a UIT, its securities, the trustee, the personnel and affiliated persons of the depositor, the distribution and redemption of securities, and financial statements. The Commission uses the information provided in the collection of information to determine compliance with section 8(b) of the Investment Company Act.
Based on the Commission's industry statistics, the Commission estimates that there would be approximately one initial filing on Form N-8B-2 and 11 post-effective amendment filings to the Form. The Commission estimates that each registrant filing an initial Form N-8B-2 would spend 44 hours in preparing and filing the Form and that the total hour burden for all initial Form N-8B-2 filings would be 44 hours. Also, the Commission estimates that each UIT filing a post-effective amendment to Form N-8B-2 would spend 16 hours in preparing and filing the amendment and that the total hour burden for all post-effective amendments to the Form would be 176 hours. By combining the total hour burdens estimated for initial Form N-8B-2 filings and post-effective amendments filings to the Form, the Commission estimates that the total
The information provided on Form N-8B-2 is mandatory. The information provided on Form N-8B-2 will not be kept confidential. The Commission may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
General comments regarding the above information should be directed to the following persons: (i) Desk Officer for the Securities and Exchange Commission, Office of Information and Regulatory Affairs, Office of Management and Budget, Room 10102, New Executive Office Building, Washington, DC 20503, or email to:
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend Amex Rule 131. The text of the proposed rule change is set forth below. Proposed new language is in
(a) through (h) No change.
(i) A fill or kill order is a market or limited price order which is to be executed in its entirety as soon as it is represented in the Trading Crowd, and such order, if not so executed, is to be treated as cancelled. For purposes of this definition, a “stop” is considered an execution.
(j) No change.
(k) An immediate or cancel order is a market or limited price order which is to be executed in whole or in part as soon as such order is represented in the Trading Crowd, and the portion not so executed is to be treated as cancelled. For the purposes of this definition, a “stop” is considered an execution.
Except as otherwise provided in the Plan, a “commitment to trade” received on the Floor through ITS shall be treated in the same manner, and entitled to the same privileges, as would an immediate or cancel order that reaches the Floor at the same time (i.e., the commitment shall be executed in whole or in part as soon as it reaches the Trading Crowd and any portion not so executed shall be cancelled); provided however, that such a commitment may not be “stopped” and the commitment shall remain irrevocable for the time period chosen by the sender of the commitment.
(l) through (t) No change.
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.
The Exchange is proposing to modify the definitions of “fill or kill” (“FOK”) and “immediate or cancel” (“IOC”) orders for equity securities to provide that if these orders were to be sent to the book electronically, and were to not be executed by Auto-Ex, the orders would be cancelled automatically. Under the proposed rule change, a person sending an FOK or IOC order to the Exchange would receive an immediate electronic report of an execution, partial execution, or a nothing done. Orders sent to the book electronically with the FOK and IOC qualifiers, accordingly, would be processed automatically without any human intervention.
The Exchange believes that modifying the processing of FOK and IOC orders sent to the book electronically so that they are automatically cancelled if not executed automatically would conform Amex practice with respect to the handling of these orders to customer expectations. Currently, the Exchange frequently receives marketable orders for securities traded in an Auto-Ex environment immediately followed by a message to cancel the orders. The Exchange believes that the persons sending these related messages are seeking an immediate automatic execution to all or part of their orders and wish to cancel whatever quantity is not executed automatically. The Exchange thus believes that these persons would use the proposed FOK and IOC orders if they were available since these orders would provide for an immediate automatic execution or cancellation and an immediate
The proposed rule change would not affect the processing of market and marketable limit orders that are sent to the order book electronically that are not subject to the FOK and IOC qualifications. Likewise, there would be no change to the processing of FOK and IOC orders sent to a floor broker for execution. The Exchange intends to implement the proposed revisions to IOC and FOK order processing when it implements its proposed enhanced Auto-Ex functionality.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act
The Exchange believes that the proposed rule change, as amended, will impose no burden on competition not necessary or appropriate in furtherance of the purposes of the Act.
No written comments were solicited or received with respect to the proposed rule change, as amended.
Because the foregoing proposed rule change, as amended, does not:
(i) Significantly affect the protection of investors or the public interest;
(ii) Impose any significant burden on competition; and
(iii) Become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate if consistent with the protection of investors and the public interest, it has become effective pursuant to Section 19(b)(3)(A) of the Act,
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change, as amended, is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an e-mail to
Send paper comments in triplicate to Jonathan G. Katz, Secretary, Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC 20549-0609.
All submissions should refer to File Number SR-Amex-2004-40. This file number should be included on the subject line if e-mail is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site (
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
On May 19, 2004, the American Stock Exchange LLC (“Amex” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Commission finds that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder applicable to a national securities exchange
Amex requested accelerated approval of the proposal in order to provide for uniform options transaction fee reductions for non-member broker-dealers and specialists, ROTs and member broker-dealers. Therefore, Amex has requested that the Commission find good cause for approving the proposal, as amended, prior to the thirtieth day after the date of publication of notice of filing thereof in the
The Commission notes that the proposal and Amendment No. 1 were noticed for the full 21-day comment period, and the Commission received no comments regarding the proposal, as amended. As discussed more fully above, the Commission believes that the proposed rule change is designed to provide for the equitable allocation of reasonable dues, fees and other charges among Exchange members and other persons using Exchange facilities. The Commission also believes that adjusting the options transaction fee reductions applicable to non-member broker-dealers to equal the fee reductions applicable to specialists, ROTs and member broker-dealers for the same types of transactions will promote uniformity in options fees charged by the Exchange. Accordingly, the Commission finds good cause pursuant to section 19(b)(2) of the Act
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The CHX proposes to amend CHX Article XX, Rule 37, regarding the execution of preopening orders in Nasdaq/NM securities. The text of the proposed rule change is below. Proposed new language is in italics; proposed deletions are in brackets.
RULE 37. (a) Guaranteed Executions. The Exchange's Guaranteed Execution System (the BEST System) shall be available, during the Primary Trading Session and the Post Primary Trading Session, to Exchange member firms and, where applicable, to members of a participating exchange who send orders to the Floor through a linkage pursuant to Rule 39 of this Article, in all issues in the specialist system which are traded in the Dual Trading System and [NASDAQ/NM]
(1) No change to text.
(2) No change to text.
(3) No change to text.
(4) Preopenings. Preopening orders in Dual Trading System issues must be accepted and filled at the primary market opening trading price. In trading halt situations occurring in the primary market, orders will be executed based upon the reopening price. Preopening orders in [NASDAQ/NM]
(b) Automated Executions. The Exchange's Midwest Automated Execution System (the MAX System) may be used to provide an automated delivery and execution facility for orders that are eligible for execution under the Exchange's BEST Rule (Article XX, Rule 37(a)) and certain other orders. In the event that an order that is subject to the BEST Rule is sent through MAX, it shall be executed in accordance with the parameters of the BEST Rule and the following. In the event that an order that is not subject to the BEST Rule is sent through MAX, it shall be executed in accordance with the parameters of the following:
(1) No change to text.
(2) No change to text.
(3) No change to text.
(4) No change to text.
(5) Pre[-O]
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for its proposal and discussed any comments it received regarding the proposal. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in Sections A, B and C below, of the most significant aspects of such statements.
Under the Exchange's current rule, a CHX specialist must accept and execute all preopening orders in Nasdaq/NM securities on a single price opening at or better than the national best bid and offer (“NBBO”) at the first unlocked, uncrossed market.
The Exchange proposes to change the operation of this rule to remove the distinction in the treatment of orders received at or before 8:20 a.m. and those received after 8:20 a.m. (Central Time) until the opening of trading. Under the proposed rule change, all orders received before the opening would be treated in the same manner. Specifically, under this proposal, an Exchange specialist would match, to the extent possible, all orders received before the Exchange's opening at a single price that is at or between the NBBO at the first unlocked, uncrossed market that occurs on or after 8:30 a.m. (Central Time).
The Exchange believes that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder that are applicable to a national securities exchange, and, in particular, with the requirements of section 6(b).
The Exchange does not believe that the proposed rule change will impose any inappropriate burden on competition.
No written comments were either solicited or received.
Within 35 days of the date of publication of this notice in the
(A) By order approve the proposed rule change, or
(B) Institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an e-mail to
• Send paper comments in triplicate to Jonathan G. Katz, Secretary, Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC 20549-0609.
All submissions should refer to File Number SR-CHX-2004-14. This file number should be included on the subject line if e-mail is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site (
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
On May 18, 2004, The Chicago Stock Exchange, Incorporated (“CHX” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Commission finds that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder applicable to a national securities exchange
The Commission finds specifically that the proposed rule change is consistent with Section 6(b)(5) of the Act,
The decision to allow the CHX to provide a 50% tape credit to specialists trading Tape A and Tape B securities, however, is narrowly drawn, and should not be construed as resolving the issues raised in the Abrogation Order, and does not suggest what, if any, future actions the Commission may take with regard to market data revenue sharing programs.
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Small Business Administration's intentions to request approval on a new and/or currently approved information collection.
Submit comments on or before September 13, 2004.
Send all comments regarding whether this information collection is necessary for the proper performance of the function of the agency, whether the burden estimates are accurate, and if there are ways to minimize the estimated burden and enhance the quality of the collection, to Eunice Ricks, Business Development Specialist, Office of Business Initiatives, Small Business Administration, 409 3rd Street SW., Suite 6100, Washington, DC 20416.
Eunice Ricks, Business Development Specialist, (202) 205-7422 or Curtis B. Rich, Management Analyst, (202) 205-7030.
Notice is hereby given that Telesoft Partners II SBIC, L.P., 1450 Fashion Island Blvd., Suite 610, San Mateo, CA 94404, a Federal Licensee under the Small Business Investment Act of 1958, as amended (“the Act”), in connection with the financing of a small concern, has sought an exemption under section 312 of the Act and section 107.730, Financings which Constitute Conflicts of Interest of the Small Business Administration (“SBA”) Rules and Regulations (13 CFR 107.730). Telesoft Partners II SBIC, L.P. proposes to provide equity/debt security financing to Sierra Design Automation, Inc. The financing is contemplated for working capital and general corporate purposes.
The financing is brought within the purview of § 107.730(a)(1) of the Regulations because Telesoft Partners II QP, L.P., Telesoft Partners II, L.P. and Telesoft NP Employee Fund, LLC, Associates of Telesoft Partners II SBIC, L.P., own more than ten percent of Sierra Design Automation, Inc.
Notice is hereby given that any interested person may submit written comments on the transaction to the Associate Administrator for Investment, U.S. Small Business Administration, 409 Third Street, SW., Washington, DC 20416.
In accordance with a notice received from the Department of Homeland Security—Federal Emergency Management Agency, effective July 7, 2004, the above numbered declaration is hereby amended to include Harrison and Holmes Counties as disaster areas due to damages caused by severe storms and flooding occurring May 18, 2004, and continuing through June 21, 2004. All other counties contiguous to the above named primary counties have been previously declared.
All other information remains the same,
In accordance with a notice received from the Department of Homeland Security—Federal Emergency Management Agency—effective July 2, 2004, the above numbered declaration is hereby amended to include Adams, Brown, Calumet, Chippewa, Clark, Crawford, Dane, Eau Claire, Grant, Green, Green Lake, Iowa, Jackson, Juneau, LaCrosse, Lafayette, Marathon, Marquette, Milwaukee, Monroe, Outagamie, Portage, Racine, Richland, Rock, Sauk, Shawano, Sheboygan, Taylor, Trempealeau, Vernon, Walworth, Washington, Waukesha, Waupaca, Waushara, and Wood Counties as disaster areas due to damages caused by severe storms and flooding occurring on May 19, 2004, and continuing.
In addition, applications for economic injury loans from small businesses located in the contiguous counties of Barron, Buffalo, Dunn, Kewaunee, Langlade, Lincoln, Manitowoc, Menominee, Oconto, Pepin, Price, and Rusk in the State of Wisconsin; Boone, Jo Daviess, Stephenson, and Winnebago Counties in the State of Illinois; Allamakee, Clayton, and Dubuque Counties in the State of Iowa; and Houston and Winona Counties in the State of Minnesota may be filed until the specified date at the previously designated location. All other counties contiguous to the above named primary counties have previously been declared. The number assigned to this disaster for economic injury is 9ZK600 for Iowa; and 9ZK700 for Minnesota.
All other information remains the same,
In accordance with a notice received from the Department of Homeland Security—Federal Emergency Management Agency, effective July 3, 2004, the above numbered declaration is hereby amended to establish the incident period for this disaster as beginning on May 19, 2004, and continuing through July 3, 2004.
All other information remains the same,
The Small Business Administration Region VIII Regulatory Fairness Board and the SBA Office of the National Ombudsman will hold a Public Hearing on Friday, July 23, 2004 at 8:30 a.m. at Montana Business Incubator, Montana State University—Billings, College of Business, 100 Poly Drive, Suite 150, Billings, MT 59101, to receive comments and testimony from small business owners, small government entities, and small non-profit organizations concerning regulatory enforcement and compliance actions taken by federal agencies.
Anyone wishing to attend or to make a presentation must contact Lorena Carlson in writing or by fax, in order to be put on the agenda. Lorena Carlson, Public Affairs Specialist, Montana District Office, 10 West 15th Street, Suite 1100, Helena, MT 59626, phone (406) 441-1081 Ext. 128, fax (406) 441-1090, e-mail:
For more information, see our Web site at
Department of State.
Notice.
Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
For further information, including a list of the exhibit objects, contact the Office of the Legal Adviser, U.S. Department of State, (telephone: (202) 619-6982). The address is U.S. Department of State, SA-44, 301 4th Street, SW., Room 700, Washington, DC 20547-0001.
Department of State.
Notice.
Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
For further information, including a list of the exhibit objects, contact the Office of the Legal Adviser, U.S. Department of State, (telephone: (202) 619-6982). The address is U.S. Department of State, SA-44, 301 4th Street, SW., Room 700, Washington, DC 20547-0001.
Department of State.
Notice.
Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
For further information, including a list of the exhibit objects covered by this Notice, contact Wolodymyr R. Sulzynsky, the Office of the Legal Adviser, U.S. Department of State, telephone: (202) 619-5078. The address is U.S. Department of State, SA-44, 301 4th Street, SW., Room 700, Washington, DC 20547-0001.
In consultation with the Secretary of the Treasury, the Attorney General, and the Secretary of Homeland Security, I have amended the designation of Continuity Irish Republican Army pursuant to Executive Order 13224 to add the following names as aliases: Continuity Army Council; Republican Sinn Fein.
Consistent with the determination in section 10 of Executive Order 13224 that “prior notice to persons determined to be subject to the Order who might have a constitutional presence in the United States would render ineffectual the blocking and other measures authorized in the Order because of the ability to transfer funds instantaneously,” no prior notice need be provided to any person subject to this determination who might have a constitutional presence in the United States, because to do so would render ineffectual the measures authorized in the Order.
Office of the United States Trade Representative.
Notice.
The United States Trade Representative (USTR) has determined that Nigeria has adopted an effective visa system and related procedures to prevent unlawful transshipment and the use of counterfeit documents in connection with shipments of textile and apparel articles and has implemented and follows, or is making substantial progress toward implementing and following, the customs procedures required by the African Growth and Opportunity Act (AGOA). Therefore, imports of eligible products from Nigeria qualify for the textile and apparel benefits provided under the AGOA.
Effective July 14, 2004.
Patrick Coleman, Director for African Affairs, Office of the United States Trade Representative, (202) 395-9514.
The AGOA (Title I of the Trade and Development Act of 2000, Pub. L. 106-200) provides preferential tariff treatment for imports of certain textile and apparel products of beneficiary sub-Saharan African countries. The textile and apparel trade benefits under the AGOA are available to imports of eligible products from countries that the President designates as “beneficiary sub-Saharan African countries,” provided that these countries: (1) Have adopted an effective visa system and related procedures to prevent unlawful transshipment and the use of counterfeit documents; and (2) have implemented and follow, or are making substantial progress toward implementing and following, certain customs procedures that assist U.S. Customs and Border Protection in verifying the origin of the products.
In Proclamation 7350 (Oct. 2, 2000), the President designated Nigeria as a “beneficiary sub-Saharan African country.” Proclamation 7350 delegated to the USTR the authority to determine whether designated countries have met the two requirements described above. The President directed the USTR to announce any such determinations in the
Accordingly, pursuant to the authority vested in the USTR by Proclamation 7350, U.S. note 7(a) to subchapter II of chapter 98 of the HTS and U.S. note 1 to subchapter XIX of chapter 98 of the HTS are each modified by inserting “Nigeria” in alphabetical sequence in the list of countries. The foregoing modifications to the HTS are effective with respect to articles entered, or withdrawn from warehouse for consumption, on or after the effective date of this notice. Importers claiming preferential tariff treatment under the AGOA for entries of textile and apparel articles should ensure that those entries meet the applicable visa requirements.
National Highway Traffic Safety Administration, DOT.
Notice.
This notice amends the Conforming Products List for instruments that conform to the Model Specifications for Evidential Breath Testing Devices (62 FR 62091).
July 14, 2004.
Dr. James F. Frank, Office of Research and Technology, Behavioral Research Division (NTI-131), National Highway Traffic Safety Administration, 400 Seventh Street, SW., Washington, DC 20590; Telephone: (202) 366-5593.
On November 5, 1973, the National Highway Traffic Safety Administration (NHTSA) published the Standards for Devices to Measure Breath Alcohol (38 FR 30459). A Qualified Products List of Evidential Breath Measurement Devices comprised of instruments that met this standard was first issued on November 21, 1974 (39 FR 41399).
On December 14, 1984 (49 FR 48854), NHTSA converted this standard to Model Specifications for Evidential Breath Testing Devices, and published a Conforming Products List (CPL) of instruments that were found to conform to the Model Specifications as Appendix D to that notice (49 FR 48864).
On September 17, 1993, NHTSA published a notice (58 FR 48705) to amend the Model Specifications. The notice changed the alcohol concentration levels at which instruments are evaluated, from 0.000, 0.050, 0.101, and 0.151 BAC, to 0.000, 0.020, 0.040, 0.080, and 0.160 BAC; added a test for the presence of acetone; and expanded the definition of alcohol to include other low molecular weight alcohols including methyl or isopropyl. On October 3, 2002, the most recent amendment to the Conforming Products List (CPL) was published (67 FR 62091), identifying those instruments found to conform with the Model Specifications.
Since the last publication of the CPL, two (2) instruments have been evaluated and found to meet the model specifications, as amended on September 17, 1993, for mobile and non-mobile use. In alphabetical order by company, they are: (1) The Alcotest 6510 manufactured by Draeger Safety, Inc., Durango, CO. This is a hand held device intended for use in stationary or roadside operation and is powered by an internal battery. It uses a fuel cell sensor. (2) The Alco-Sensor FST manufactured by Intoximeters, Inc, St. Louis, MO. This is a hand held device intended for use in stationary or roadside operation and is powered by an internal battery. It uses a fuel cell sensor. Finally, a technical correction has to be made in the name of one device on the CPL. The current CPL lists the “Intox EC/IR 2” manufactured by Intoximeters, Inc., St. Louis, MO, but the device should be listed as “Intox EC/IR II.”
The CPL has been amended to add the two instruments identified above to the list, and to make the one technical correction indicated.
In accordance with the foregoing, the CPL is therefore amended, as set forth below.
Cooper Tire & Rubber Company (Cooper) has determined that certain tires it manufactured during 2004 do not comply with S6.5(f) of Federal Motor Vehicle Safety Standard (FMVSS) No. 119, “New pneumatic tires for vehicles other than passenger cars.” Pursuant to 49 U.S.C. 30118(d) and 30120(h), Cooper has petitioned for a determination that this noncompliance is inconsequential to motor vehicle safety and has filed an appropriate report pursuant to 49 CFR Part 573, “Defect and Noncompliance Reports.” Notice of receipt of a petition was published, with a 30-day comment period, on May 7, 2004 in the
S6.5(f) of FMVSS No. 119 requires that each tire shall be marked on each sidewall with “the actual number of plies and the composition of the ply cord material in the sidewall.” Cooper produced approximately 148 size 11R24.5 Cooper and Mastercraft brand tubeless radial tires during the period from February 29, 2004 through March 6, 2004 that do not comply with FMVSS No. 119, S6.5(f). These tires were marked “tread 5 plies steel; sidewall 1 ply steel,” when they should have been marked “tread 4 plies steel; sidewall 1 ply steel.”
Cooper stated that the incorrect number of steel tread plies was removed from the molds by buffing and the correct number of steel tread plies inserted; however, prior to the molds being correctly stamped, 148 tires were inadvertently shipped.
Cooper stated that the incorrect number of steel tread plies on each tire does not present a safety issue. Cooper explained:
The involved tires have been redesigned by Cooper, and the fifth steel belt removed. This change was done to improve tread wear resistance and has no effect on the tire's ability to meet all applicable DOT testing standards. The certification data from the redesigned four steel ply construction showed no remarkable difference when compared to the equivalent certification data for the previous five ply steel construction. Both sets of data are well in excess of DOT requirements.
Cooper stated that the involved tires comply with all other requirements of FMVSS No. 119.
One comment was received in response to the notice of receipt. The commenter, Barb Sashaw of Florham Park, NJ, stated:
I do not think there should be any exemption for Cooper Tires. This company violated federal standards. Cooper tried to make money since 5 ply cots [sic] more than 4 ply and Cooper would then make higher profits. It may have been a blatant attempt to steal money because consumers would pay more for an inferior tire.
The issue to be considered in determining whether to grant this petition is the effect of the noncompliance on motor vehicle safety. The comment does not address this issue, and therefore is not persuasive in its argument that the petition should not be granted.
The agency agrees with Cooper's statement that the incorrect designation of 5 plies when there were actually 4 plies in each tire does not present a serious safety concern. The agency believes that the true measure of inconsequentiality to motor vehicle safety in this case is that there is no effect of the noncompliance on the operational safety of vehicles on which these tires are mounted.
Although tire construction affects the strength and durability, neither the agency nor the tire industry provides information relating tire strength and durability to the number of plies and types of ply cord material in the tread and sidewall. Therefore, tire dealers and customers should consider the tire construction information along with other information such as the load capacity, maximum inflation pressure, and tread wear, temperature, and traction ratings, to assess performance capabilities of various tires. In the agency's judgment, the incorrect labeling of the tire construction information will have an inconsequential effect on motor vehicle safety because most consumers do not base tire purchases or vehicle operation parameters on the number of plies in a tire.
In addition, the tires are certified to meet all the performance requirements of FMVSS No. 119. All other informational markings as required by FMVSS No. 119 are present. Cooper has corrected the problem.
In consideration of the foregoing, NHTSA has decided that the petitioner has met its burden of persuasion that the noncompliance described is inconsequential to motor vehicle safety. Accordingly, Cooper's petition is granted and the petitioner is exempted from the obligation of providing notification of, and a remedy for, the noncompliance.
(49 U.S.C. 30118, 30120; delegations of authority at 49 CFR 1.50 and 501.8).
General Motors Corporation (GM) has determined that certain 2004 model year Saab 9-3 Sport Sedans and Convertibles do not comply with S4.2(b) of 49 CFR 571.114, Federal Motor Vehicle Safety Standard (FMVSS) No. 114, “Theft protection.” GM has filed an appropriate report pursuant to 49 CFR Part 573, “Defect and Noncompliance Reports.”
Pursuant to 49 U.S.C. 30118(d) and 30120(h), GM has petitioned for an exemption from the notification and remedy requirements of 49 U.S.C. Chapter 301 on the basis that this noncompliance is inconsequential to motor vehicle safety.
This notice of receipt of GM's petition is published under 49 U.S.C. 30118 and 30120 and does not represent any agency decision or other exercise of judgment concerning the merits of the petition.
Within a total of approximately 4032 model year 2004 Saab 9-3 Sport Sedans and Convertibles equipped with a manual transmission, approximately 11 are affected. S4.2(b) of FMVSS No. 114 requires that “[e]ach vehicle shall have a key-locking system which, whenever the key is removed, prevents either steering or forward self-mobility of the vehicle or both.” The affected vehicles were produced with an ignition key locking system that contains a center spring plate switch that can bind in the closed position. This switch communicates to certain vehicle systems that the ignition key has been inserted or removed. When this switch binds in the closed position, certain systems will read that the ignition key is still in the ignition switch, even after ignition key removal. One of the systems using the input from this switch is the electronic steering column lock to meet the S4.2 requirement of FMVSS No. 114. If a vehicle has the aforementioned condition, the steering column will not lock upon ignition key removal.
GM believes that the noncompliance is inconsequential to motor vehicle safety for the following reasons stated in its petition:
Continued Theft Protection: FMVSS No. 114 was developed to increase road safety by reducing the risk of traffic accidents resulting from unauthorized vehicle operation. All Saab 9-3 vehicles are equipped with an electronic engine immobilizer system that prevents engine operation in the absence of the vehicle's ignition key from the ignition switch module. The immobilizer remains fully operation[al] on vehicles with the aforementioned condition present. Although a vehicle could be steered with this condition, the engine could not be started, even through hot-wiring or other vehicle manipulation. GM considers the immobilizer system to be at least as effective as a steering column lock in preventing vehicle theft. NHTSA and Highway Loss Data Institute data have also confirmed the effectiveness of passively activated engine immobilizers such as that present on the 9-3.
Overt Symptoms: When this condition occurs, the symptoms are very obvious to the customer. Upon key removal the radio/CD player stays on, interior lights will not operate and the remote door locking function will not operate. Additionally, even though the key has been removed, the key warning system will activate when the driver's door is opened. These symptoms will induce the customer to return to the dealer for repairs under the new car warranty.
Failure Occurs Early and only a Small Percentage of Vehicles are Affected: If this condition is present, it is most likely to occur very early in the vehicle's life. In an analysis performed by the component supplier (Delphi), it was estimated that of the components affected by this condition, 85 percent would fail within the first month and 99 percent would fail within six months. Most occurrences have been and will be caught prior to retail delivery. * * * It has been estimated by the supplier of the ignition switch assembly that as of the end of April 2004, a maximum of 15 additional vehicles might experience this condition. Saab warranty data show that 4 warranty repairs have been performed since May 1, 2004. Therefore, based on this projection, a maximum of 11 additional units could be expected to be subject to this condition. We would expect any of these additional instances to occur over the next few months.
GM states that the problem has been corrected.
Interested persons are invited to submit written data, views, and arguments on the petition described above. Comments must refer to the docket and notice number cited at the beginning of this notice and be submitted by any of the following methods. Mail: Docket Management Facility, U.S. Department of Transportation, Nassif Building, Room PL-401, 400 Seventh Street, SW., Washington, DC, 20590-0001. Hand Delivery: Room PL-401 on the plaza level of the Nassif Building, 400 Seventh Street, SW., Washington, DC. It is requested, but not required, that two copies of the comments be provided. The Docket Section is open on weekdays from 10 am to 5 pm except Federal Holidays. Comments may be submitted electronically by logging onto the Docket Management System Web site at
The petition, supporting materials, and all comments received before the close of business on the closing date indicated below will be filed and will be considered. All comments and supporting materials received after the closing date will also be filed and will be considered to the extent possible. When the petition is granted or denied, notice of the decision will be published in the
(49 U.S.C. 30118, 30120: delegations of authority at 49 CFR 1.50 and 501.8)
Timber Rock Railroad, Inc. (TRRR), a Class III rail carrier, has filed a verified notice of exemption under 49 CFR 1150.41 to acquire by lease and to operate approximately 117.82 miles of rail line owned by The Burlington Northern and Santa Fe Railway Company (BNSF): (1) Between milepost 4.5 near Beaumont, TX, and milepost 21.8 near Silsbee, TX; (2) between milepost 52.5 near Dobbin, TX, and milepost 152.56 at Silsbee, TX, and (3) between milepost 0.5 and milepost 0.96 near Kirbyville, TX.
TRRR certifies that its projected revenues as a result of this transaction will not result in the creation of a Class II or a Class I rail carrier. But, because TRRR's projected annual revenues will exceed $5 million, TRRR has certified to the Board on May 4, 2004, that it sent the required notice of the transaction on May 3, 2004, to the national offices of all labor unions representing employees on the affected lines and posted a copy of the notice at the workplace of the employees on the affected lines on May 2, 2004.
The transaction was scheduled to be consummated on or after July 3, 2004 (which is 60 days or more after TRRR's certification to the Board that it had complied with the Board's rule at 49 CFR 1150.42(e)).
If the notice contains false or misleading information, the exemption is void
An original and 10 copies of all pleadings, referring to STB Finance Docket No. 34503, must be filed with the Surface Transportation Board, 1925 K Street, NW., Washington, DC 20423-0001. Also, a copy of each pleading must be served on Karl Morell, Ball Janik LLP, Suite 225, 1455 F Street, NW., Washington, DC 20005.
Board decisions and notices are available on our Web site at
By the Board, David M. Konschnik, Director, Office of Proceedings.
CSX
CSXT has certified that: (1) No local traffic has moved over the line for at least 2 years; (2) there is no overhead traffic to be rerouted; (3) no formal complaint filed by a user of rail service on the line (or by a state or local government entity acting on behalf of such user) regarding cessation of service over the line either is pending with the
As a condition to this exemption, any employee adversely affected by the abandonment shall be protected under
A copy of any petition filed with the Board should be sent to the applicant's representative: Louis E. Gitomer, 1455 F Street, NW., Suite 225, Washington, DC 20005.
If the verified notice contains false or misleading information, the exemption is void
CSXT has filed an environmental report which addresses the abandonment's effects, if any, on the environment and historic resources. SEA will issue an environmental assessment (EA) by July 12, 2004. Interested persons may obtain a copy of the EA by writing to SEA (Room 500, Surface Transportation Board, Washington, DC 20423-0001) or by calling SEA, at (202) 565-1539. (Assistance for the hearing impaired is available through the Federal Information Relay Service (FIRS) at 1-800-877-8339.) Comments on environmental and historic preservation matters must be filed within 15 days after the EA becomes available to the public.
Environmental, historic preservation, public use, or trail use/rail banking conditions will be imposed, where appropriate, in a subsequent decision.
Pursuant to the provisions of 49 CFR 1152.29(e)(2), CSXT shall file a notice of consummation with the Board to signify that it has exercised the authority granted and fully abandoned the line. If consummation has not been effected by CSXT's filing of a notice of consummation by July 7, 2005, and there are no legal or regulatory barriers to consummation, the authority to abandon will automatically expire.
Board decisions and notices are available on our Web site at
By the Board, David M. Konschnik, Director, Office of Proceedings.
The Department of Treasury has submitted the following public information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Copies of the submission(s) may be obtained by calling the Treasury Bureau Clearance Officer listed. Comments regarding this information collection should be addressed to the OMB reviewer listed and to the Treasury Department Clearance Officer, Department of the Treasury, Room 11000, 1750 Pennsylvania Avenue, NW., Washington, DC 20220.
Written comments should be received on or before August 13, 2004, to be assured of consideration.
The Department of the Treasury has submitted the following public information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Copies of the submission(s) may be obtained by calling the Treasury Bureau Clearance Officer listed. Comments regarding this information collection should be addressed to the OMB reviewer listed and to the Treasury Department Clearance Officer, Department of the Treasury, Room 11000, 1750 Pennsylvania Avenue, NW., Washington, DC 20220.
Written comments should be received on or before August 13, 2004, to be assured of consideration.
The Department of Treasury has submitted the following public information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Copies of the submission(s) may be obtained by calling the Treasury Bureau Clearance Officer listed. Comments regarding this information collection should be addressed to the OMB reviewer listed and to the Treasury Department Clearance Officer, Department of the Treasury, Room 11000, 1750 Pennsylvania Avenue, NW., Washington, DC 20220.
Written comments should be received on or before August 13, 2004, to be assured of consideration.
The Department of Treasury has submitted the following public information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995,
Written comments should be received on or before August 13, 2004, to be assured of consideration.
Recordkeeping—2 hr., 43 min.
Learning about the law or the form—1 hr., 6 min.
Preparing the form—2 hr., 51 min.
Copying, assembling, and sending the form to the IRS—34 min.
Recordkeeping—38 hr., 29 min.
Learning about the law or the form—4 hr., 16 min.
Preparing and sending the form to the IRS—5 hr., 5 min.
Department of Veterans Affairs.
Notice of fund availability.
The Department of Veterans Affairs (VA) is announcing the availability of funds for currently operational VA Homeless Providers Grant and Per Diem Recipients that are providing services at the time of the application to make applications for assistance in the delivery of services to the homeless chronically mentally ill veteran population. The focus of this Notice of Fund Availability (NOFA) under the Special Needs Grant Component of VA's Homeless Providers Grant and Per Diem (GPD) Program is to encourage applicants to collaborate with VA Health Care Facilities in the delivery of such services. This NOFA contains information concerning the program, application process, and amount of funding available.
Applicants should take this practice into account and make early submission of their material to avoid any risk of loss of eligibility brought about by unanticipated delays or other delivery-related problems.
Guy Liedke, VA Homeless Providers Grant and Per Diem Program, Department of Veterans Affairs, 10770 N. 46th Street, Suite C-100, Tampa, FL 33617; (toll-free) 1-877-332-0334.
This NOFA announces the availability of funds for assistance under the VA Homeless Providers Grant and Per Diem Program (Program) for eligible operational grant and per diem recipients to receive grant assistance with additional operational costs
“Chronically mentally ill” is for purposes of this Program defined in 38 CFR 61.1, Definitions, as: * * * a condition of schizophrenia or major affective disorder (including bipolar disorder) or post-traumatic stress disorder (PTSD), based on a diagnosis from a licensed mental health professional, with at least one documented hospitalization for this condition sometime in the last 2 years or with documentation of a formal assessment on a standardized scale of any serious symptomology or serious impairment in the areas of work, family relations, thinking, or mood.”
It is widely accepted by the mental health community that the chronically mentally ill population requires additional resources due to the intensive nature of their care.
Additionally, it has been noted that a significant contributing factor to homelessness is chronic mental illness. Consequently, VA has decided to offer funding to providers who serve this special need population in a separate NOFA. In an effort to prevent non-duplication of services, encourage cost effectiveness, and ensure the use of appropriate models for treatment of the chronically mentally ill, a funding priority will be given to applicants who collaborate their delivery of services to this veteran population with their local VA Medical Center by agreeing to use a portion of their funding to provide services within the guidelines of the models listed in this NOFA.
VA is seeking, through this NOFA, to identify and select several grant and per diem providers and VA Health Care Facilities to collaborate through the use of the “Critical Time Intervention” (CTI) model and “Vet-to-Vet” (VTV) counseling/assistance model with “Permanent Housing Assistance” (PHA) that will involve treatment of the chronically mentally ill homeless veteran population. Eligible applicants that choose to provide these types of services to the homeless chronically mentally ill will be given a funding priority (
Public Law 107-95, the Homeless Veterans Comprehensive Assistance Act of 2001, authorizes this Program. It authorizes grants to be offered to both VA health care facilities and operational grant and per diem providers to encourage development by those facilities and providers of programs for homeless veterans with special needs (38 U.S.C. 2061).
Grant and per diem providers may only apply under this Notice for: The provision of service, operation, or personnel with regard to the homeless chronically mentally ill special needs veteran population.
Generally, providers may, in addition to establishing the Vet-to-Vet/Permanent Housing Assistance model, offer the following:
(1) Help participants join in and engage with the community;
(2) Facilitate reintegration with the community and provide services that may optimize reintegration, such as life-skills education, recreational activities, and follow-up case management;
(3) Ensure that participants have opportunities and services for re-establishing relationships with family;
(4) Ensure adequate supervision, including supervision of medication and monitoring of medication compliance; and
(5) Provide opportunities for participants, either directly or through referral, to obtain other services particularly relevant for a chronically mentally ill population, such as vocational development, benefits management, fiduciary or money management services, medication compliance, and medication education.
Successful applicants will be required to designate at least one representative from the organization to attend a post-award conference. The conference will be held in Washington, DC and is expected to extend over a two-day period. Applicants will be required to cover costs of travel, lodging, and meals associated with their attendance at the post-award conference; however, these costs can be included in budgets submitted for consideration for reimbursement of allowable costs under the grant.
No part of a special need grant may be used for any purpose that would change significantly the scope of the specific grant and per diem project for which a capital grant and per diem was awarded. As a part of the review process, VA will review the original project listed in the special need application to ensure significant scope changes do not occur displacing other homeless veteran populations. VA may reject for Special Needs Funding those applications that significantly alter the original scope (38 CFR 61.62).
A separate special needs application is required for each previously funded grant and per diem project identified by unique project number (
Special needs funding
VA's Homeless Providers Grant and Per Diem Program is authorized by Pub. L. 107-95, the Homeless Veterans Comprehensive Assistance Act of 2001, section 5(a)(1), codified at 38 U.S.C. chapter 20 (38 U.S.C. 2001 through 2066). The program is implemented by regulations at 38 CFR part 61, codifying final rules published in the
It is important to be aware that VA places great emphasis on responsibility and accountability. VA has procedures in place to monitor services provided to homeless veterans and outcomes associated with the services provided in grant and per diem-funded programs. Applicants should be aware of the following:
VA per diem payment is limited to the applicant's cost of care per eligible veteran minus other sources of payments to the applicant for furnishing services to homeless veterans up to the per day rate VA pays for State Home Domiciliary care, which is currently $27.19. Additionally, potential applicants should take into consideration the provisions of 38 CFR 61.61(h): “Grant recipients that concurrently receive per diem and special needs payments shall not be paid more than 100 percent of the cost for the bed per day, product, operation, personnel, or service provided.” Awardees will be required to support their request for per diem and special needs payments with adequate fiscal documentation as to program income and expenses.
All awardees that are conditionally selected in response to this NOFA must meet the Life Safety Code of the National Fire and Protection Association as it relates to their specific facility. VA will conduct an inspection or review a current inspection prior to awardees being able to submit a request for payment, to ensure this requirement is met.
Each grant awardee will have the VA liaison that was appointed for its corresponding grant and per diem program monitor services to ensure the special needs grant is being met.
Monitoring will include at least an annual review of each program's progress toward meeting internal goals and objectives in helping the chronically mentally ill homeless veterans as identified in each applicant's original special need application. Monitoring for all participants will also include a review of the agency's income and expenses as they relate to this project to ensure per diem and special needs payments are accurate.
Monitoring of Homeless CMI participants and services provided by GPD recipients and VA collaborative partners will be accomplished according to Northeast Program Evaluation Center (NEPEC) procedures. In the event that the special needs funded program has chosen a collaborative partner, participation in the NEPEC monitoring will also include the collaborative partner. These monitoring procedures will be used to determine successful accomplishment of outcomes for each funded program.
VA encourages all faith-based and community organizations that are eligible entities to carefully review this
The work of the VA CTI team can be described in three phases. During the first phase (3 months) the team establishes a working relationship with the homeless veteran to identify their needs and develop a treatment plan and begin its implementation. During this period the treatment plan is implemented, where possible and appropriate, with placement in a grant and per diem residence on a time-limited basis.
The second 3 months is focused on the transition to the community and to a permanent housing placement wherever possible or another appropriate long-term arrangement where specifically indicated.
The third 3-month period would be devoted to a transition out of the VA CTI Program and into mainstream permanent housing coupled with mainstream mental health and general medical clinical supports as needed.
A primary portal of entry for this program would be inpatient units where the most seriously troubled, dually diagnosed, homeless veterans could also be referred from other sources. Severity of the population's need and duration of homelessness will be important considerations in application reviews. The target population would be veterans who have been homeless for 30 days or more (when last in the community) and who have severe mental illness and co-morbid substance abuse. A second target population would be severely mentally ill homeless veterans who had been homeless for less than a month, are in need of intensive services, but were not currently hospitalized. A third target population would be severely mentally ill veterans who are not literally homeless at present but who have been homeless in the past and are currently at high risk for homelessness.
The Vet-to-Vet Program is based on a model of peer education, specifically targeted at veterans with serious mental illness. In this educational effort, veterans with serious mental illness, many of whom have been homeless, provide a daily group activity in which homeless veterans with mental illnesses learn from each other how to cope with serious mental illness and how to cope with leaving the ranks of homelessness and return to living as independently as possible in society. Peer educator groups meet every day on an elective basis. While staff may help initiate the program, it is operated by veterans for themselves and the peer counselors are paid for their efforts.
The Permanent Housing Assistance Program is based on community referral models and community supported-housing program models successfully implemented to assist the chronically mentally ill homeless population
Funding for operational grant and per diem applicants that are finally selected will be for a period not to exceed 36 months beginning on January 1, 2005. VA collaborative partners of finally selected applicants will be funded in accordance with Department internal fiscal guidance for a period of 36 months beginning on January 1, 2005.
Should either the VA collaborative partner or GPD provider not provide services as outlined in their application and MOA, VA may deobligate or discontinue payments for special needs grants to either or both collaborative partners.
A condition to obtain the Special Needs Grant is for the applicant to maintain the original (grant or per diem) program for which the special needs grant is sought. This is not a problem when considering eligible capital grantees. However, by VA calculation it is possible that some of the eligible “Per Diem Only” applicant programs would have their original award expire prior to fully utilizing the special needs funding. This is counterproductive to the intent of the special needs grant. Therefore, if finally selected, “Per Diem Only” applicants will be considered to have met the reapplication requirements of 38 CFR 61.33(b) and their corresponding per diem only award will be extended to run concurrently with their special needs grant. Example: A “Per Diem Only” award funded in 2003 would expire in 2006. Based on the funding availability date of January 1, 2005, if selected under this special need NOFA that corresponding PDO award would be extended to December 31, 2007.
The grant application requirements are specified in the application package and this NOFA. The package includes the applicant's required forms and certifications. Additional collaborative documentation as outlined in this NOFA is needed to collaborate with a VA health care facility for the purpose of this grant. Selections will be made based on criteria described in the application and this NOFA. Applicants who are selected will be notified of any additional information needed to confirm or clarify information provided in the application. Applicants will then be notified of the deadline to submit such information. If an applicant is unable to meet any conditions for grant award within the specified time frame, VA reserves the right to not award funds and to use the funds available for other grant and per diem applicants.
Eligible operational grant and per diem recipients that choose to participate in the study must provide a jointly signed Memorandum of Agreement (MOA) with the applicant agency and the VA collaborative partner under which, if funded, the VA health care facility and the community-based grant and per diem provider agree to offer the services, staff, and documentation as described in the evaluation procedures developed by NEPEC.
Department of Veterans Affairs.
Notice of fund availability.
The Department of Veterans Affairs is announcing the availability of funds for currently operational Homeless Providers Grant and Per Diem Recipients that are providing services at the time of the application to make applications for assistance in the delivery of services to the homeless veteran population of women, including women who have care of minor dependents; frail elderly; or terminally ill. The focus of this Notice of Fund Availability (NOFA) under the special needs grant component of VA's Homeless Providers Grant and Per Diem Program is to encourage applicants to collaborate with VA Health Care Facilities in the delivery of such services. This NOFA contains information concerning the program, application process, and amount of funding available.
Guy Liedke, VA Homeless Providers Grant and Per Diem Program, Department of Veterans Affairs, 10770 N. 46th Street, Suite C-100, Tampa, FL 33617; (toll-free) 1-877-332-0334.
This NOFA announces the availability of funds for assistance under the VA Homeless Providers Grant and Per Diem Program (Program) for eligible operational grant and per diem recipients with and without VA collaborative partners to assist with additional operational costs
Public Law 107-95, the Homeless Veterans Comprehensive Assistance Act of 2001, authorizes this Program. No part of a special needs grant may be used for any purpose that would change significantly the scope of the project for which a capital grant and per diem was awarded. As a part of the review process VA will review the original project listed in the special needs application to ensure significant scope changes do not occur, displacing other homeless veteran populations. VA may reject for special needs funding those applications that significantly alter the original scope (38 CFR 61.62).
A separate application is needed for each population and the provider would use the same project number on each application.
A separate special needs application is required for each previously funded grant and per diem project, for each special population targeted to be served (
Funding applied for under this notice may be used for: the provision of service, operation, or personnel to facilitate the following with regard to the targeted group:
(1) Ensure the safety of the residents in the facility to include preventing harm and exploitation;
(2) Ensure opportunities to keep residents mentally and physically agile to the fullest extent through the incorporation of structured activities, physical activity, and plans for social engagement within the program and in the community;
(3) Provide opportunities for participants to address life-transitional issues and separation and/or loss issues;
(4) Provide access to assistance devices such as walkers, grippers, or other devices necessary for optimal functioning;
(5) Ensure adequate supervision, including supervision of medication and monitoring of medication compliance; and
(6) Provide opportunities for participants either directly or through referral for other services particularly relevant for the frail elderly, including services or programs addressing emotional, social, spiritual, and generative needs.
(1) Help participants address life-transition and life-end issues;
(2) Ensure that participants are afforded timely access to hospice services;
(3) Provide opportunities for participants to engage in “tasks of dying,” or activities of “getting things in order” or other therapeutic actions that help resolve end of life issues and enable transition and closure;
(4) Ensure adequate supervision including supervision of medication and monitoring of medication compliance; and
(5) Provide opportunities for participants either directly or through referral for other services particularly relevant for terminally ill such as legal counsel and pain management.
Successful applicants will be required to designate at least one representative from the organization to attend a post-award conference. The conference will be held in Washington, DC, and is expected to extend over a two-day period. Applicants will be required to cover costs of travel, lodging, and meals associated with their attendance at the post-award conference; however, these costs can be included in budgets submitted for consideration for reimbursement of allowable costs under the grant.
VA's Homeless Providers Grant and Per Diem Program is authorized by Pub. L. 107-95, the Homeless Veterans Comprehensive Assistance Act of 2001, section 5(a)(1), codified at 38 U.S.C. chapter 20 (38 U.S.C. 2001 through 2066). The program is implemented by regulations at 38 CFR part 61, codifying final rules published in the
It is important for interested organizations to know that in addition to the needs associated with the homeless veteran populations targeted in this NOFA, the vast majority of homeless veterans in this country suffer from mental illness or substance abuse disorders or are dually diagnosed with both mental illness and substance abuse disorders. Also, many homeless veterans have serious medical problems.
Public Law 107-95 authorizes grants to be offered to both VA Health Care Facilities and operational Grant and Per Diem Providers to encourage development by those facilities and providers of programs for homeless veterans with special needs (38 U.S.C. 2061). In an effort to prevent non-duplication of services and encourage cost effectiveness, a funding priority will be given to applicants who collaborate their delivery of services to the special need homeless veterans population with their local VA Medical Center (VAMC) or VA Community Based Outpatient Clinic (CBOC), VA Women's Program, Health Care for Homeless Veterans (HCHV) Program, Domiciliary Care for Homeless Veterans (DCHV) Program or other VA specialty programs at a VAMC or VA CBOC that may be instrumental in developing programs to address the special needs of homeless veterans (
It is important to be aware that VA places great emphasis on responsibility and accountability. VA has procedures in place to monitor services provided to homeless veterans and outcomes associated with the services provided in grant and per diem-funded programs. Applicants should be aware of the following:
VA per diem payment is limited to the applicant's cost of care per eligible veteran minus other sources of payments to the applicant for furnishing services to homeless veterans up to the per day rate VA pays for State Home Domiciliary care, which is currently $27.19. Additionally, potential applicants should take into consideration the provisions of 38 CFR 61.61(h): “Grant recipients that concurrently receive per diem and special needs payments shall not be paid more than 100 percent of the cost for the bed per day, product, operation, personnel, or service provided.” VA would expect that programs that apply for special needs funding that will serve special needs homeless veterans in less than 20 beds will adjust their request for funding appropriately to be cost effective. Awardees will be required to support their request for per diem and special needs payments with adequate fiscal documentation as to program income and expenses.
All awardees that are conditionally selected in response to this NOFA must meet the Life Safety Code of the National Fire and Protection Association as it relates to their specific facility. VA will conduct an inspection or review the current inspection prior to awardees being able to submit a request for payment, to ensure this requirement is met.
Each special needs grant awardee will have the VA liaison that was appointed for its corresponding grant and per diem program monitor services to ensure the special needs grant is being met.
Monitoring will include at least an annual review of each program's progress toward meeting internal goals and objectives in helping special needs homeless veterans as identified in each applicant's original special needs application. Monitoring will also include a review of the agency's income and expenses as they relate to this project to ensure per diem and special needs payments are accurate.
Each special needs funded program will participate in VA's national program monitoring and evaluation system administered by VA's Northeast Program Evaluation Center (NEPEC). In the event that the special needs funded program has chosen a collaborative partner; participation in the NEPEC program will also include the collaborative partner. NEPEC's monitoring procedures will be used to
VA encourages all eligible faith-based and community organizations that are eligible entities to carefully review this NOFA and consider applying for funds to provide services for special needs homeless veteran populations.
Documentation is to be provided by the VA collaborative partner in a jointly signed MOA with the applicant agency stating that if funded the VA collaborative partner will provide the services as outlined in the MOA. The MOA must document the non-duplication of services through collaboration and must address the following:
The special population and number to be served;
The extent and level of services that will be provided by the VA collaborative partner;
How these services compliment and not duplicate the services provided by the applicant;
Process and outcome measures clearly delineated and linked to service delivery and responsibilities for collection, compilation, and reporting of these measures;
Approximate cost to provide these services per year, and over the life of the grant; and
The VA collaborative partner will only provide services to eligible veterans.
Funding for operational grant and per diem applicants that are finally selected will be for a period not to exceed 36 months beginning on January 1, 2005. VA collaborative partners of finally selected applicants will be funded in accordance with Department internal fiscal guidance for a period of 36 months beginning on January 1, 2005. Should either of the collaborative partners not provide services as outlined in their application and MOA, VA may deobligate or discontinue payments for special needs grants to one or both collaborative partners.
A condition to obtain the special needs grant is for the applicant to maintain the original (Grant or Per Diem) program for which the special needs grant is sought. This is not an issue for eligible capital grantees. However, it is possible that some of the eligible “Per Diem Only” applicant programs would have their original award expire prior to fully utilizing the special needs funding. This is counterproductive to the intent of the special need grant. Therefore, if finally selected, “Per Diem Only” applicants will be considered to have met the reapplication requirements of 38 CFR 61.33(b) and their corresponding Per Diem Only award will be extended to run concurrently with their special needs grant. Example: A “Per Diem Only” award funded in 2003 would expire in 2006. Based on the funding availability date of January 1, 2005, if selected under this special need NOFA that corresponding PDO award would be extended to December 31, 2007.
The grant application requirements are specified in the application package and this NOFA. The package includes the applicant's required forms and certifications. Additional collaborative documentation as outlined in this NOFA is needed if the applicant chooses to collaborate with a VA health care facility. Selections will be made based on criteria described in the application and this NOFA. Applicants who are selected will be notified of any additional information needed to confirm or clarify information provided in the application. Applicants will then be notified of the deadline to submit such information. If an applicant is unable to meet any conditions for grant award within the specified time frame, VA reserves the right to not award funds
Department of Veterans Affairs.
Notice.
The Department of Veterans Affairs (VA) is announcing the availability of funds for applications for assistance under the Technical Assistance Grant component of VA's Homeless Providers Grant and Per Diem Program. This notice contains information concerning the program, application process, and amount of funding available.
An original completed and collated grant application (plus three completed collated copies) for assistance under the VA's Homeless Providers Grant and Per Diem Program must be received in the Grant and Per Diem Field Office on August 17, 2004. Applications may not be sent by facsimile (fax). In the interest of fairness to all competing applicants, this deadline is firm as to date and hour, and VA will treat as ineligible for consideration any application that is received after the deadline. Applicants should take this practice into account and make early submission of their material to avoid any risk of loss of eligibility brought about by unanticipated delays or other delivery-related problems.
Guy Liedke, VA Homeless Providers Grant and Per Diem Program, Department of Veterans Affairs, 10770 North 46th Street, Suite C-100, Tampa, FL 33617; (toll-free) 1-877-332-0334.
This notice announces the availability of funds for assistance under VA's Homeless Providers Grant and Per Diem Program for eligible non-profit entities with expertise in preparing grant applications relating to the provision of assistance for homeless veterans to: Provide technical assistance to those non-profit community-based groups with experience in providing assistance to homeless veterans in order to help such groups apply for grants under the final rule, published in the
Public Law 107-95, the Homeless Veterans Comprehensive Assistance Act of 2001, authorizes this program. Funding applied for under this notice may be used for: (a) Group or individual seminars providing general instructions concerning grant applications; (b) Group or individual seminars providing instructions for applying for a specific grant; or (c) Group or individual instruction for preparing analyses to be included in a grant application. Seminars (course of instruction) may be delivered in electronic, face-to-face, and correspondence methodologies (
Entities that are interested in providing technical assistance should be aware that historically the Grant and Per Diem Program office receives over 1,200 nationwide inquiries per Notice of Fund Availability from prospective applicants. It is estimated that an additional 1,000 inquiries are received nationwide at VA Medical Center Homeless Programs. From these inquiries, VA has seen an increase in the number of applicants each year. Approximately 100 to 300 applications per funding round have been received in past responses to Notices of Fund Availability (NOFAs) under VA’s Homeless Providers Grant and Per Diem Program. Additionally, faith-based organizations that are capable of providing supported housing and/or supportive service center services for homeless veterans have figured prominently into the mix of non-profit organizations seeking funding. Approximately 2500 beds in 115 programs have come from faith-based organizations. Those entities applying to provide technical assistance should consider not only the numbers but the diversity of the service provider seeking assistance when establishing their service plans.
The applicant for this funding will be expected to develop an integrated technical assistance plan, using funds for purposes as specified in this NOFA, the objectives of the program rules and regulations, as well as the intent of Public Law 107-95, to offer technical assistance to agencies in their-specified target area. Applicants should take note that they will be held accountable to provide to VA documentation that demonstrates the objectives of technical training are being met throughout the course of the award cycle and documentation that clearly demonstrates the completion of technical assistance objectives were met, cumulatively, at the end of the funding period. Also, VA intends to conduct both fiscal and performance reviews at least bi-annually of the awarded agency(s). The technical assistance should not only raise the awareness of providers regarding the availability of funds to assist homeless veterans but also increase providers' proficiency in applying for funds to assist homeless veterans. Applicants should take the aforementioned into consideration when developing a technical assistance plan. Outcomes measures that are specific and measurable should be an integral part of the technical assistance plan that is submitted in the application.
Grant applicants may not receive assistance to replace funds provided by any State or local government for the same purpose.
VA's Homeless Providers Grant and Per Diem Program is authorized by Public Law 107-95, section 5(a)(1), the Homeless Veterans Comprehensive Assistance Act of 2001 codified at title 38 United States Code (U.S.C.) 2011, 2012, 2061, 2064 and has been extended through Fiscal Year 2005. The program is implemented by the final rule codified at title 38 CFR 61.0. The regulations can be found in their entirety in title 38 CFR 61.0 through 61.82. Funds made available under this notice are subject to the requirements of those regulations.
Food and Drug Administration, HHS.
Interim final rule.
The Food and Drug Administration (FDA) is issuing an interim final rule (interim final rule) to prohibit the use of certain cattle material, to address the potential risk of bovine spongiform encephalopathy (BSE), in human food, including dietary supplements, and cosmetics. Prohibited cattle materials include specified risk materials, small intestine of all cattle, material from nonambulatory disabled cattle, material from cattle not inspected and passed for human consumption, and mechanically separated (MS)(Beef). Specified risk materials are the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months and older; and the tonsils and distal ileum of the small intestine of all cattle. Prohibited cattle materials do not include tallow that contains no more than 0.15 percent hexane-insoluble impurities and tallow derivatives. FDA is taking this action in response to the finding of an adult cow, imported from Canada, that tested positive for BSE in the State of Washington. This action is consistent with the recent interim final rule issued by the U.S. Department of Agriculture (USDA) declaring specified risk materials and the carcasses and parts of nonambulatory disabled cattle to be inedible, unfit for human food, and prohibiting their use as human food and requiring that the entire small intestine be removed and disposed of as inedible. This action will minimize human exposure to materials that scientific studies have demonstrated are highly likely to contain the BSE agent in cattle infected with the disease. Scientists believe that the human disease variant Creutzfeldt-Jakob disease (vCJD) is likely caused by the consumption of products contaminated with the agent that causes BSE. Also in this issue of the
The interim final rule is effective on July 14, 2004. Submit written or electronic comments by October 12, 2004. The Director of the Office of the Federal Register approves the incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of certain publications in 21 CFR 189.5 and 700.27 as of July 14, 2004.
You may submit comments, identified by Docket No. 2004N-0081, by any of the following methods:
• Federal eRulemaking Portal:
• Agency Web site:
• E-mail: fdadockets@oc.fda.gov. Include Docket No. 2004N-0081 and or RIN number RIN-0910-AF47 in the subject line of your e-mail message.
• FAX: 301-827-6870.
• Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Rebecca Buckner, Center for Food Safety and Applied Nutrition (HFS-306), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1486.
On January 26, 2004, the Department of Health and Human Services announced new safeguards to strengthen existing firewalls against transmission of bovine spongiform encephalopathy (BSE) in the United States. This interim final rule, will protect the food and cosmetic supply from materials that may carry a risk of transmitting BSE. Consumption of products contaminated with agent that causes BSE has been linked to a human disease. The United States is currently protected from the spread of BSE by import controls, increased surveillance for the disease in the cattle population, FDA's 1997 ruminant feed regulation, and the United States Department of Agriculture's (USDA's) ban on specified risk materials and certain other cattle material in human food. This interim final rule complements USDA's ban for FDA-regulated human food and cosmetics.
Transmissible spongiform encephalopathies (TSEs) are fatal neurodegenerative disorders, which have been identified in humans and a number of animal species (e.g., cattle, sheep, goats, elk, deer, cats, and mink), but primarily in ruminants (cattle, sheep, elk, deer). TSEs are characterized by a long incubation period, then a shorter course of neurological symptoms, followed by death (Ref. 1). Postmortem histopathology of the brain tissue from humans and animals with TSEs is characterized by a sponge-like appearance of the brain and deposits of abnormal forms of certain cell-associated proteins (normal prion proteins) in the brain. In some TSEs, deposits of abnormal prion proteins are detected in other nervous and non-nervous tissues, such as the spinal cord, peripheral nerves, intestine, spleen, lymph nodes, and bone marrow (Refs. 2 to 6).
TSEs in humans include sporadic CJD, variant Creutzfeldt-Jakob disease (vCJD), Gerstmann-Straussler-Scheinker syndrome, kuru, fatal familial insomnia, and sporadic fatal insomnia (Ref. 7). Nonhuman TSEs include BSE in cattle, scrapie in sheep and goats, transmissible mink encephalopathy (TME) in mink, feline spongiform encephalopathy (FSE) in cats, and chronic wasting disease (CWD) in deer and elk (Ref. 7). Scrapie and CWD occur, and TME has occurred, in the United States. On December 23, 2003, USDA diagnosed BSE in an adult cow
The pathogenesis of TSEs is poorly understood. Resistance of TSE agents to physical and chemical treatments that would destroy most nucleic acids makes conventional micro-organisms, such as bacteria and viruses, less likely causes (Ref. 8). The prion theory suggests that the infectious agents of TSEs are abnormally folded forms of normal prion proteins, and is the most widely accepted explanation (Ref. 9). Normal prion protein genes are found widely in nature. In mammals, normal prion proteins are primarily expressed in neurons, but also can be found in other tissues in lower concentrations, depending on the mammalian species (Ref. 10). It is not well understood how the abnormal folding of prion proteins occurs, why hosts cannot efficiently dispose of or develop immunity to these proteins, and what factors cause some TSEs.
The current lack of an antemortem diagnostic test for TSEs in either humans or animals limits surveillance for these diseases, studies of disease pathogenesis, and other research efforts. Diagnosis is confirmed by special post-mortem examination of brain tissue by identification of abnormal prion proteins in advanced stages of the disease. At earlier stages of disease development, abnormal prion proteins may not yet be present or are undetectable in brain tissue. Presently, there are no effective treatments for TSEs, and all are invariably fatal (Ref. 1).
BSE is a TSE of cattle with a long incubation period (2 to 8 years), most likely acquired following consumption of an animal product containing the infectious BSE agent (Refs. 11 and 12). The British Ministry of Agriculture, Fisheries and Food (now known as the Department for Environment, Food, and Rural Affairs) first recognized BSE as a distinct disease in November 1986. The clinical signs of BSE include behavioral, gait, and postural abnormalities. The disease usually presents in cattle observed to have increased apprehension, increased reaction to sound and touch, and a swaying gait. These signs are accompanied by subtle changes in the normal behavior of the cow, such as separation from the herd while at pasture, disorientation, staring, and excessive licking of the nose or flanks. The disease progresses to stumbling and falling, and ends with seizures, coma, and death (Ref. 13).
Epidemiological studies have characterized the outbreak of BSE in the United Kingdom as a prolonged epidemic arising at various locations, with all occurrences due to a common source, and have suggested that feed contaminated by a TSE agent was the cause of the disease outbreak (Ref. 14). The subsequent spread of BSE, however, is associated with the feeding of meat-and-bone-meal from rendered BSE-infected cattle to non-infected cattle (Ref. 14). It appears likely that the BSE agent was transmitted among cattle at an increasing rate by ruminant-to-ruminant feeding until the United Kingdom ban on such practices went into effect in 1988 (Ref. 11). The United Kingdom instituted a ruminant-to-ruminant feed ban to stop the cycle of infection, restrict the geographic spread of the disease, and eliminate potential sources of new infections. Since BSE was first identified in the United Kingdom, approximately 185,000 cattle have been diagnosed with the disease there (Ref. 15). The precautionary slaughter of millions of British cows and increasingly stringent prohibitions on certain animal feeding practices appear to have slowed, but not eradicated, the BSE epidemic in the United Kingdom. In 1992 (the peak year of the epidemic), there were over 35,000 cases of BSE in the United Kingdom; in 2003, there were approximately 458 cases (Ref. 15).
The measures used to control and prevent the spread of BSE in the United Kingdom were too slowly developed or too poorly enforced to prevent the occurrence of BSE in cattle in other countries to which the United Kingdom had shipped BSE-infected cattle or cattle feed (Ref. 11). In addition to the United Kingdom, BSE has been detected in non-imported cattle in Austria, Belgium, Canada, the Czech Republic, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Liechtenstein, Luxembourg, the Netherlands, Poland, Portugal, the Republic of Ireland, Slovakia, Slovenia, Spain, and Switzerland (Ref. 15). On December 23, 2003, USDA diagnosed a positive case of BSE in an adult Holstein cow, born in Canada, in the State of Washington.
CJD is a sporadic disease of humans that exists throughout the world with an annual incidence of approximately one case per million population (Ref. 9). The highest death rates in the United States and the United Kingdom occur in individuals between the ages of 60 and 70 (Ref. 16). Death generally occurs after less than a year of progressive neurological deterioration (Ref. 9). Early symptoms typically include changes in sleeping and eating patterns, followed by inappropriate behavior and eventual dementia, lack of coordination, and myoclonic spasms. CJD is always fatal (Ref. 16). The cause of sporadic CJD is not fully understood, but genetic susceptibility may play a role (Ref. 9). CJD has been inadvertently transmitted between humans during medical treatment or diagnostic procedures via contaminated neurosurgical instruments, transplants of dura mater and corneas, injection of pituitary extract, and cross-contamination from medical personnel who handled tissues from patients with CJD (Ref. 9).
In April 1996, British scientists reported a previously undetected new variant of CJD (vCJD) in young patients, with symptoms somewhat different from sporadic CJD (Refs. 17 and 18). All cases of vCJD had histopathologic evidence of spongiform changes in the brain, but also showed formation of “florid” plaques (a core of amyloid protein with surrounding halos of vacuoles) not typically seen in other forms of CJD (Ref. 9). Clinically, vCJD usually begins with a psychiatric presentation, such as depression, anxiety, nightmares or hallucinations. These symptoms are followed by memory impairment, then dementia in the late stages. The clinical course may last up to 2 years before death occurs (Ref. 19).
Because scientific evidence suggests that the presence and infectivity of abnormal prion proteins in vCJD share some characteristics with those abnormal prion proteins found in cattle with BSE, scientists have concluded that exposure to the BSE agent is the most plausible explanation for the occurrence of vCJD (Refs. 20 to 23). Monkeys (genetically the closest animal model to humans) inoculated with samples of brain from BSE-infected cattle have been found to develop a TSE that is histopathologically similar to vCJD (Ref. 24), as have mice inoculated or fed with BSE-infected tissue (Ref. 25). Studies have shown that abnormal prion proteins from vCJD patients are molecularly similar to abnormal prion proteins from BSE-infected cattle, but different from abnormal prion proteins from patients with CJD (Ref. 19). Although the exact route of exposure is not known, most scientists believe that vCJD in humans is caused by consumption of cattle products contaminated with the agent that causes BSE (Refs. 16, 26, and 27).
Since 1996, approximately 150 probable and confirmed cases of vCJD have been reported in the United Kingdom. In addition, one case of vCJD each has been reported in Ireland and
In 1998, USDA asked the Harvard Center for Risk Analysis (HCRA) and the Center for Computational Epidemiology at Tuskegee University to evaluate United States measures to prevent the spread of BSE to animals and humans if it were to occur in this country. The Harvard-Tuskegee risk assessment (referred to below as the Harvard-Tuskegee study) was published in November 2001, revised in 2003, and determined that the United States was highly resistant to any proliferation of BSE or a similar disease (Ref. 29). The risk assessment model also demonstrated that certain new control measures could reduce the small risk even further.
The Harvard-Tuskegee study involved a probabilistic simulation model to determine the consequences of introducing BSE into the U.S. cattle population. This simulation indicated that, in a hypothetical situation in which 10 infected cattle were imported into the United States, on average only four new cases of BSE would arise, and the disease would be eliminated in 20 years. The Harvard-Tuskegee study determined that these new cases of BSE would most likely arise in the United States from incomplete compliance with FDA's ruminant feed regulation (see III.A of this document), and also concluded that an epidemic of BSE in this country resulting from scrapie, CWD, or another TSE is unlikely.
The Harvard-Tuskegee study estimated the number of cattle infectious doses that might be available for human exposure, but it did not estimate the likelihood of human disease from this exposure because the relationship between the two is not known. According to the study, the estimated total infectivity available for human exposure from the importation of 10 infected cattle is 35 cattle infectious doses over 20 years. The Harvard-Tuskegee study determined that the greatest sources of infectivity to consumers are direct consumption of cattle brain and spinal cord and also meat from advanced meat recovery systems that contains central nervous system tissue. The Harvard-Tuskegee study did not address potential human exposure to the BSE agent through food containing ingredients of cattle origin, such as gelatin, beef stocks, extracts, and flavorings or cosmetics.
The Harvard-Tuskegee study identified three pathways that could lead to cattle or human exposure to the BSE agent: (1) Noncompliance with FDA's ruminant feed regulation prohibiting the use of certain proteins in feed for cattle and other ruminants; (2) rendering of animals that die on the farm, and use (through illegal diversion or cross-contamination) of the rendered product in ruminant feed; and (3) the inclusion of high-risk tissues from cattle, such as brain and spinal cord, in products for human oral consumption. Evaluation of potential risk mitigation measures in the study found that a prohibition against rendering of animals that die on the farm would reduce the potential cases of BSE following hypothetical exposure by 82 percent. In addition, a ban on specified risk materials (SRMs) including brain, spinal cord, and vertebral column from inclusion in human and animal food would reduce potential BSE cases in cattle by 88 percent and potential human exposure to BSE by 95 percent. The Harvard-Tuskegee study also noted the value of ensuring that low-risk cattle tissues are not cross-contaminated with high-risk tissue.
In 2003, after the discovery of a case of BSE in a cow in Canada, the USDA asked HCRA to evaluate the implications of the hypothetical previous introduction of BSE in the United States from Canada. The HCRA model indicated that the potential for spread of BSE among cattle and the potential for human exposure to BSE increase as the time period lengthens between the introduction of infected Canadian cattle and FDA's issuance of the ruminant feed regulation in 1997 (i.e., there is more potential for spread of BSE if the infected cattle were imported from Canada in 1990 versus 1996). In the worst case scenario involving importation of five infected animals from Canada, BSE would be eliminated from the United States with high probability by 2020 (Ref. 30).
Data on the distribution of BSE infectivity in tissues are incomplete, and there are ongoing experiments with cattle to confirm and update earlier data (Refs. 2 to 6 and 31). In a pathogenesis study in which cattle tissues were assayed for infectivity following intracerebral inoculation of tissues from cattle orally exposed to the BSE agent, distal ileum and spinal cord were found to harbor infectivity as early as 6 months post-inoculation for distal ileum and 32 months post-inoculation for spinal cord (Refs. 3 and 4). In one experiment, cattle were experimentally infected with BSE through consumption of the brains of cattle with BSE. Infectivity in the tissues of the cattle consuming the brains was evaluated by mouse bioassay. In the mouse bioassay, infectivity was detected in brain, spinal cord, dorsal root ganglia (clusters of nerve cells attached to the spinal cord that are contained within the bones of the vertebral column), trigeminal ganglia (clusters of nerve cells connected to the brain that lie close to the exterior of the skull), and distal ileum. All of the central nervous system (CNS) tissues were found to be infective in animals 32 to 40 months after exposure to the BSE agent, which in some cases could be months before anticipated onset of clinical signs of illness. This study was done with relatively few animals (n=30), and the experimental conditions do not reflect field conditions of disease transmission. Therefore, a second phase of the experiment was initiated, and will continue for several more years, to determine if any of the tissues that initially did not appear to be infective actually contain low levels of infection. Preliminary results from this study have indicated that tonsil, at 10 months after exposure, carries a low level of infectivity (Ref. 31).
In cattle infected with BSE under field conditions, infectivity has been found in the brain, spinal cord, and retina of the eye in animals with clinical disease (Ref. 31). The Scientific Steering Committee of the European Union (Ref. 27) has reported on the proportion of total infectivity in various tissues. They estimate that, in an animal with clinical disease, approximately 64 percent of the infectivity is in the brain, 26 percent is in the spinal cord, 4 percent is in the dorsal root ganglia, 2.5 percent is in the trigeminal ganglia, and 3 percent is in the distal ileum. The eyes are estimated to contain less than 1 percent of the infectivity.
Based on the information presented previously and consistent with the USDA's regulation (69 FR 1862, January 12, 2004; discussed in section II of this document), we have determined that the tissues with the highest risk of harboring BSE infectivity (the SRMs) are
As discussed in the previous section, most tissues that harbor BSE infectivity have been shown to do so in animals more than 30 months after exposure to the agent. The exceptions are tonsils, which have been shown to harbor infectivity at low levels at 10 months post-exposure, and the distal ileum, which has been shown to harbor infectivity as early as 6 months post-exposure. In a study of the BSE epidemic in the United Kingdom, Dealler and Lacey (Ref. 32) noted that only 29 of 5,470 animals younger than 36 months of age developed BSE, with the peak number of cases occurring between 48 and 60 months of age. At the height of the BSE epidemic in the United Kingdom when thousands of animals were being diagnosed with BSE each year, fewer than 20 animals younger than 30 months were confirmed with the disease (Ref. 33). The youngest animal with a confirmed case of BSE was 20 months old (Ref. 15).
Though animals younger than 30 months can develop BSE, it is a very rare occurrence, based on epidemiological and experimental evidence. Therefore, we have concluded that brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia should be considered SRMs only in cattle 30 months and older.
We are aware that there have been documented cases of BSE in animals younger than 30 months, and that some tissues become infectious before the animal exhibits clinical signs. As mentioned previously, during the height of the BSE epidemic in the United Kingdom, a small number of animals younger than 30 months showed signs of the disease. More recently, Japan has reported cases of BSE in 21- and 23-month-old animals, discovered during testing of animals presented for slaughter. As the science and epidemiology on this issue develop, FDA may find it necessary to modify the age period for SRM removal through future rulemaking.
Based on experimental evidence, we have concluded that the tonsil and distal ileum of the small intestine of all cattle should be considered SRMs.
To ensure effective removal of the distal ileum, USDA is requiring that the entire small intestine be removed and disposed of as inedible product. FDA is also prohibiting the use of the entire small intestine in FDA-regulated food and cosmetics as prohibited cattle material. We are doing so because: (1) It is difficult to distinguish one end of the small intestine from the other once the organ has been removed from the animal, (2) there is no international agreement on how much of the small intestine should be removed to ensure that the distal ileum is separated from the upper part of the intestine, and (3) there is no way for a manufacturer or processor to document that the distal ileum was adequately removed since there is no international consensus on the issue. USDA has solicited comment on whether processors may be able to effectively remove just the distal ileum. FDA requests comment on this issue as it affects FDA's rule.
MS(Species) is a standardized food defined by the USDA in 9 CFR 319.5 (see section IV.A of this document for definition of MS(Beef)). The standard does not limit the amount of spinal cord and dorsal root ganglia that can contaminate vertebral column used to produce the product. Consequently, MS(Beef) may contain concentrated amounts of such tissues. Because we have concluded that spinal cord, dorsal root ganglia and vertebral column are all SRMs, we are designating MS(Beef) as a prohibited cattle material.
Experience has shown that nonambulatory disabled cattle (see section IV.A of this document for definition) are the population at greatest risk for harboring BSE. Surveillance data in the European Union in 2002 showed that there were 29 positive/10,000 tests for BSE among healthy-appearing cattle of all ages and 148 positive/10,000 tests for BSE among nonambulatory animals of all ages (Ref. 34). In Switzerland, sampling of particular populations of cattle revealed that BSE-positive animals were 49 to 58 times more likely to be found in the nonambulatory population than in the population selected for passive slaughter surveillance (Ref. 35). The Harvard-Tuskegee study estimated that, following importation of 10 infected cattle, a prohibition against rendering animals that die on the farm (these animals are usually nonambulatory disabled) would decrease the number of new cases of BSE by 82 percent.
Because typical clinical signs of BSE cannot always be observed in nonambulatory disabled cattle, and because evidence has indicated these cattle are more likely to have BSE than apparently healthy cattle, FDA is designating material from nonambulatory disabled cattle as prohibited cattle materials.
For cattle that are not inspected (see section IV.A of this document for definition), there is no information as to their suitability for use in human food and cosmetics in general, and as to their disease status and potential for harboring BSE in particular. In addition, such cattle are likely to have died on the farm or en route to slaughter, and these animals are not eligible for inspection by the USDA. Therefore, these cattle are at higher risk of harboring undetected BSE. For cattle that are inspected but not passed, a regulatory authority (USDA or other) has made a determination that they are not appropriate for use in human food. Such a determination may be based, among other things, on evidence of a neurological disorder associated with a higher risk of BSE. Moreover, material from cattle not inspected or inspected and not passed for human consumption is prohibited from human food by USDA. By requiring that material from cattle for use in FDA-regulated human food and cosmetics be inspected and passed for human consumption, we are minimizing the risk of exposure to the agent that causes BSE, and extending the protections offered by the USDA or the appropriate regulatory authority in other countries to FDA-regulated human food and cosmetics.
No practical antemortem tests for BSE exist. The currently available postmortem tests, although useful for disease surveillance (i.e., determining the rate of disease in the population of
Some dietary supplements contain cattle-derived materials (e.g., liver powder, brain, ovaries, eye tissue, mammary tissue, adrenal gland, hypothalamus) or substances derived from these tissues. On March 13, 2003 (68 FR 12158), FDA proposed current good manufacturing practice (CGMP) regulations for dietary ingredients and dietary supplements. In the proposal, we recognized that animal-derived ingredients in dietary supplements present important public health and safety issues and that some dietary supplements contain material from cattle that may contain the infective agent that causes BSE. We also stated that, in the absence of broadly applicable or validated diagnostic tests available to manufacturers to identify BSE-infected animals or materials, the agency is considering whether to set forth specific requirements designed to prevent the use of materials derived from certain animals from regions that may present a risk of BSE. Further, in the proposal we sought comment, among other things, on whether we should include in the final rule specific requirements for manufacturing, packing, or holding all animal-derived dietary ingredients, including cattle-derived ingredients, whether or not they originate from areas with BSE. FDA will respond to those comments in a final dietary supplement CGMP rule and consistent with the provisions of this rule, which applies to all human food, including dietary supplements.
Cosmetics may be made from a variety of cattle-derived ingredients. Tallow derivatives, particularly fatty acids and glycerin, are the predominant bovine ingredient used by the cosmetic industry. Additionally, ingredients sometimes include albumin, brain extract, brain lipid, cholesterol, fibronectin, sphingolipids, collagen, keratin, and tallow. Cattle-derived ingredients serve many functions and may be used as skin conditioning agents, emollients, binders, and hair and nail conditioning agents.
There are several routes through which cosmetics contaminated with the agent that causes BSE could transmit disease to humans. Transmission of the BSE agent to humans through intact skin is not likely; however, cosmetics may be ingested or applied to cut or abraded skin or to mucosal tissues, particularly in the eye, which could provide direct routes for infection.
Although injection into the eye does not represent normal human contact with cosmetics, experimental studies in animals may provide relevant information on potential routes of exposure. In mice, intraocular injection of scrapie caused infection along the optic nerve, which eventually spread into non-neural tissue via the lymphatic system (Ref. 38). In addition to intraocular injection, infectivity has been transmitted to animals via the conjunctiva of the eye (mucosal tissue). Scott et al. (Ref. 39) found that scrapie was induced in 42 percent of rodents by dropping a high concentration of infectivity onto the conjunctiva. Klitzman et al. (Ref. 40) suggested that kuru, a human TSE disease found only among the Fore people of New Guinea, might have been transmitted by rubbing infected human brain into eyes or cut skin, while handling and consuming infected brain during funeral rituals.
Cut or abraded skin also has been proposed as a route for contracting TSE diseases. The transmission of kuru through cut skin has been suggested and was mentioned previously (Taylor et al. (Ref. 41) and Ingrosso et al. (Ref. 42)) demonstrated increased transmission of scrapie via oral mucosal tissue. In one study, 100 percent of mice with experimentally damaged oral mucosal tissue developed scrapie through ingestion of infected material, while only 71 percent of mice with intact mucosa developed the disease (Ref. 41). In addition, Pammer et al. (Ref. 43) and Sugaya et al. (Ref. 44) noted that epithelial cells, dendritic cells, and keratinocytes (the primary cell types found in the epidermis) have been found to contain infectious prion protein, indicating that these cells are potential targets for peripheral infection with a TSE disease.
Use of BSE-contaminated cosmetics could provide a means of human infection via several routes discussed previously. Many cosmetics are typically applied in the area of the eye (mascara, eye brow pencil, eyeliner, eye lotion, and eye makeup remover) and almost any cosmetic, including shampoo, can get into the eye via eye rubbing or incorrect application. Any cosmetic product, but particularly shaving creams and gels and lotions, may be applied to cut or abraded skin. Many products may come in contact with mucosal tissue via rubbing. Cosmetics that are ingested, such as lipstick, dentifrices, mouthwash, and breath fresheners, would have the same route of infection as the feeding studies mentioned previously, if the cosmetics were contaminated with the agent that causes BSE.
Tallow is an animal-derived hard fat that has been heat processed; most tallow is derived from cattle. Any risk of BSE transmission from tallow is a result of protein that is present as an impurity in the tallow. Taylor et al. (Refs. 45 and 46) found in rendering studies with abnormal prion protein that the prion protein did not preferentially migrate into the fat fraction, but remained with the protein fraction. Therefore, there is no reason to believe that tallow is likely to contain unusually high amounts of prion protein as a constituent of the insoluble impurities fraction that remains in tallow after rendering. Taylor et al. (Refs. 45 and 46) also reported that the various rendering processes used for tallow production in the United Kingdom were sufficient to produce tallow that did not result in infection when injected into the brains of mice, even though the starting material was highly spiked with the scrapie agent. Wilesmith et al. (Ref. 47) noted that the geographical variation in the incidence of BSE in the United Kingdom was not consistent with the use of tallow in cattle feed and concluded that the most likely source of infection in cattle was BSE-contaminated meat and bone meal.
The Office International des Epizooties (OIE), the international animal health standard setting body, categorizes tallow with insoluble impurities of no more than 0.15 percent as protein-free tallow and indicates that tallow that meets this standard can be safely consumed by animals regardless of the starting materials (Ref. 48). There is thought to be a 10- to 10,000-fold increase in the amount of infectious material needed to cause illness in humans as compared with cattle because of the species barrier, though the European Commission's Scientific Steering Committee cautioned that this
Based on the research and the opinions noted previously, we are permitting tallow to be used in human food and cosmetics if it contains no more than 0.15 percent hexane-insoluble impurities or otherwise complies with these regulations. We believe we are adequately protecting human health by requiring a tallow standard for human food and cosmetics that is as protective as the standard recommended by OIE to prevent BSE in cattle.
Tallow derivatives are produced by subjecting tallow to chemical processes (hydrolysis, trans-esterification, and saponification) that involve high temperature and pressure. The TSEAC considered tallow derivatives in 1998 (Ref. 50) and determined that the rigorous conditions of manufacture are sufficient to further reduce the BSE risk in tallow derivatives. In addition, the OIE also recommends that derivatives of protein-free tallow be freely traded among countries because they pose insignificant BSE risk to animals (Ref. 48). Because we believe that tallow has negligible risk of transmitting BSE, and tallow derivatives undergo additional processing, we do not believe that tallow derivatives pose a risk of transmitting the agent that causes BSE to humans.
On January 12, 2004, in response to the diagnosis of BSE in a cow in the United States, USDA published a series of interim final rules including “Prohibition of the Use of Specified Risk Materials for Human Food and Requirements for the Disposition of Non-Ambulatory Disabled Cattle” (69 FR 1862). The rule declares that SRMs are inedible and unfit for food and prohibits their use as human food. The rule designates the following as SRMs: The brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months of age and older, and the tonsils and distal ileum of the small intestine of all cattle. To ensure the distal ileum is completely removed, the entire intestine must be removed and disposed of as inedible. The rule also declares that MS(Beef) is unfit for food and inedible. In addition, the rule requires that all nonambulatory disabled cattle presented for slaughter be condemned and not used in human food. Furthermore, the rule requires that establishments that slaughter cattle or that process the carcasses or parts of carcasses of cattle maintain daily records sufficient to document the implementation and monitoring of procedures for removal, segregation, and disposition of SRMs. Finally, the rule deems all age-associated SRMs (all SRMs except tonsil and distal ileum) to be from animals 30 months or older unless an establishment can demonstrate that the materials are from an animal that was younger than 30 months of age at the time of slaughter.
In this interim final rule, FDA is extending similar protections to FDA-regulated human food and cosmetics. The USDA's interim final rule will reduce but will not, by itself, eliminate the availability and use of prohibited cattle materials in domestic and imported FDA-regulated human food and cosmetics. Domestically, generally human food that contains meat only in a relatively small proportion or that historically has not been considered by consumers to be products of the meat food industry (e.g., soup stock, beef flavors and extracts, gelatin), is not produced under USDA inspection (see definition of “meat food product” in 21 U.S.C. 601(j)) and may be physically available for use in FDA-regulated human food and cosmetics. Further, even when excluded from human food produced in USDA-inspected establishments, prohibited cattle materials may leave the establishments for inedible rendering or destruction. These materials, which previously have not been explicitly prohibited in human food and cosmetics by FDA, might then be used in FDA-regulated human food or cosmetics. For example, prohibited cattle materials leaving a USDA-inspected facility might not be denatured sufficiently to preclude their use in FDA-regulated human food and cosmetics.
Under the Food Safety and Inspection Services' (FSIS') rule, SRMs, small intestine from all cattle, and material from nonambulatory disabled cattle must be designated as inedible. However, certain products, such as gelatin and collagen (which are both covered by the provisions of this rule) used in FDA-regulated human food and cosmetics, have traditionally been produced from cattle material deemed inedible by the USDA. Therefore, such a designation by the USDA may not be enough to preclude use of prohibited cattle materials in FDA-regulated products without additional regulation by FDA. Further, some cattle are not slaughtered under continuous USDA inspection (e.g., some are sent directly to rendering). Cattle material from these animals, such as brains or bones which include SRMs, could end up as starting material for human food, such as meat extracts or gelatin, respectively. Furthermore, if prohibited cattle materials were used in FDA-regulated human food or cosmetics, the rule would facilitate FDA's ability to use the enforcement mechanisms of the Federal Food, Drug, and Cosmetic Act (the act) that apply to adulterated products (e.g., seizure) to prevent human exposure to the prohibited cattle materials.
Imported products also may contain the types of materials prohibited by the USDA, but which would not fall within the scope of the USDA's import regulations either because of the nature of the products or their country of origin. Specifically, although both FSIS and Animal and Plant Health Inspection Service (APHIS) impose BSE-related prohibitions, these prohibitions collectively do not cover all FDA-regulated human food and cosmetics. FSIS' restrictions, contained in its interim final rule described earlier in this document, do not apply to importation of dietary supplements, cosmetics, and FDA-regulated human food not considered to be “meat food products” under the Federal Meat Inspection Act (21 U.S.C. 601(j)).
APHIS' BSE-related restrictions on imports do not cover gelatin for human use (beyond requiring a permit) or cosmetics, and apply only to a limited number of countries (9 CFR 94.18).
In the
During the past decade, we have communicated with the public and manufacturers, applicants, importers, and processors of FDA-regulated human food and cosmetics about appropriate steps to increase product safety and minimize the risk of products being contaminated with the BSE agent. Most of our communications have been in the form of letters and guidance to industry and import alerts.
• November 1992—We wrote to manufacturers of dietary supplements to alert them to the developing concern about TSEs in animals and CJD in humans and recommended that they investigate the geographic sources of any bovine and ovine material used in their products. We suggested that manufacturers develop plans to ensure, with a high degree of certainty, that bovine and ovine materials used in their products were not from countries where BSE exists (“BSE countries” specified by USDA's APHIS in 9 CFR 94.18) or from sheep flocks (foreign or domestic) infected with scrapie.
• August 1994—We published a notice in the
• October 1994—We issued Import Alert 17-04, which allowed for the detention, without examination, of bulk shipments of high-risk bovine tissues and tissue-derived ingredients from BSE countries. When FDA issued Import Alert 17-04 in 1994, the list of BSE countries included the United Kingdom, France, Ireland, Oman, Switzerland, and Portugal. We have updated this alert whenever APHIS has revised the list of countries in 9 CFR 94.18.
• May 1996—We sent a letter to manufacturers and importers of dietary supplements and cosmetics stating that FDA strongly believed that manufacturers should take immediate and concrete steps to reduce the potential risk of human exposure to the BSE infectious agent.
• October 1997—We published a notice of availability (62 FR 52345, October 7, 1997) of a guidance for industry entitled “The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in FDA-Regulated Products for Human Use.” In the guidance FDA recommends, among other things, that gelatin processors ensure that slaughterhouses that supply cattle bones for gelatin production remove heads, spines, and spinal cords as the first procedure following slaughter.
In new §§ 189.5(a) and 700.27(a) (21 CFR 189.5(a) and 21 CFR 700.27(a)) we are defining the following terms for the purposes of this regulation:
1.
2.
3.
4.
5.
6.
7.
USDA recently declared SRMs and MS(Beef) unfit for food and inedible and prohibited their use in human food. USDA also required that all nonambulatory disabled cattle
Scientists believe that the human disease vCJD is likely caused by the consumption of products contaminated with the agent that causes BSE. The relationship between the agent that causes BSE and human cases of vCJD has been described in section I.C of this document. Contamination of products with infected cattle CNS tissue is believed to have led to the development of vCJD in humans (Refs. 16, 26, and 27).
Currently, no practical method for testing products for the agent that causes BSE is available and, therefore, we do not have a means of distinguishing products that contain infectious material from products that do not. Consumers also often are not able to determine which products contain prohibited cattle materials and which products do not. For example, rendered products including brain and spinal cord may become ingredients in soups, broths, meat flavors, extracts, dietary supplements and cosmetics, where their presence may not be indicated as such on the label. Furthermore, consumers have no way to determine whether animal material in a human food or cosmetic was sourced from nonambulatory disabled cattle or from cattle that were not inspected and passed for human consumption.
In addition to being unable to test for infectious material in products, we also do not know the infectious dose for humans. Despite widespread exposure in the United Kingdom to BSE-contaminated meat products, only a very small percentage of the exposed population has been diagnosed with vCJD to date. However, ongoing experiments indicate that the infectious dose for cattle is very low. One gram of affected cattle brain homogenate is sufficient to cause BSE in more than 50 percent of calves exposed by mouth. Five years after oral consumption of lower doses of brain material, 2 of 15 calves fed 0.1 gram had developed BSE, and 1 of 15 fed 0.01 gram had developed the disease. This experiment is ongoing (Ref. 51). There is thought to be a 10- to 10,000-fold increase in the amount of infectious material needed to cause illness in humans, as compared with cattle, because of the species barrier (Ref. 49).
We know that consumption of contaminated material has caused illness in humans, although we do not know the infectious dose, and we cannot test to determine which products contain infectious material. Therefore, we have provided in § 189.5(b) that no human food shall be manufactured from, processed with, or otherwise contain prohibited cattle materials, and in § 700.27(b) that no cosmetic shall be manufactured from, processed with, or otherwise contain, prohibited cattle materials.
FDA is applying these requirements for prohibited cattle materials to all products or ingredients of products manufactured in the U.S. or imported into the U.S. In an advanced notice of proposed rulemaking, entitled “Federal Measures to Mitigate BSE Risks: Considerations for Further Actions,” published by APHIS, FSIS, and FDA in this issue of the Federal Register, FSIS is seeking comment on the issue of equivalence and BSE requirements. Likewise, FDA requests comment on standards to apply when determining another country's BSE status, providing an exemption for “BSE-free” countries, and how to determine that countries meet any standards that might be developed. FDA intends to work with USDA in developing a harmonized U.S. position on exempting other countries from our respective requirements related to BSE.
Tallow is defined in §§ 189.5(a)(6) and 700.27(a)(6) as “the rendered fat of cattle obtained by pressing or by applying any other extraction process to tissues derived directly from discrete adipose tissue masses or to other carcass parts and tissues.” Tallow derivatives are defined in §§ 189.5(a)(7) and 700.27(a)(7) as “any chemical obtained through initial hydrolysis, saponification, or trans-esterification of tallow or the chemical conversion of material obtained by hydrolysis, saponification, or trans-esterification.” For the reason described in section I.K of this document, we provide in §§ 189.5(a)(1) and 700.27(a)(1) that tallow with no more than a 0.15 percent hexane-insoluble impurities and tallow derivatives are not considered prohibited cattle materials under this rule. We are requiring in §§ 189.5(a)(6) and 700.27(a)(6) that you measure the hexane-insoluble impurities in tallow by the method for “hexane-insoluble matter” described in the 5th edition of the Food Chemicals Codex (Institute of Medicine, National Academies of Science) and incorporated by reference into this rule or by another method that is at least equivalent in accuracy, precision and sensitivity to the method described in the Food Chemicals Codex, 5th edition. Tallow that contains more than 0.15 percent hexane-insoluble impurities may be used if it complies with the requirements for cattle materials in § 189.5 for human food and § 700.27 for cosmetics.
We note that, regardless of its purity level, tallow to be used in human food and cosmetics is subject to the other provisions of the act and is adulterated, for example, if it has been prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth (21 U.S.C. 342(a)(4)).
We are requiring in §§ 189.5(c) and 700.27(c) that manufacturers and processors of human food and cosmetics that are manufactured from, processed with, or otherwise contain, material from cattle must make existing records relevant to compliance with this rule available to FDA for inspection and copying. We believe that records documenting the absence of prohibited cattle materials in human food and cosmetics are critical for manufacturers, processors, and FDA to ensure compliance with the prohibitions on the use of prohibited cattle materials in this interim final rule. Once material is removed from cattle, we may not be able to obtain the information necessary to determine whether it is prohibited cattle materials. There is currently no way to test reliably for the presence of the BSE agent or for the presence of prohibited cattle materials. Therefore, manufacturers and processors of human food and cosmetics must depend on records from the suppliers of cattle material to demonstrate that their supplier's cattle material does not contain prohibited cattle materials.
The agency believes that recordkeeping and records access requirements are necessary immediately. The agency, however, recognizes that recordkeeping systems cannot be put into place immediately and, therefore, to include recordkeeping requirements in this interim final rule could result in manufacturers and processors immediately being in violation of the adulteration provisions of the act with respect to human food and cosmetics because of their failure
The prohibitions contained in § 189.5 (b) apply to all FDA-regulated human food, except tallow and tallow derivatives. “Human food” is “food” as that term is defined in section 201(f) of the act (21 U.S.C. 321(f)), except for animal food. Specifically, “human food” is: (1) Articles used for food or drink for man, (2) chewing gum, and (3) articles used for components of any such article. “Human food” includes, but is not limited to, food additives, including substances that migrate into food from food packaging and other articles that contact food, color additives, dietary supplements and dietary ingredients, and infant formula.
The prohibitions contained in § 700.27 (b) apply to all FDA-regulated cosmetics. “Cosmetic” is defined in section 201(i) of the act (21 U.S.C. 321(i)) as
(1) articles intended to be rubbed, poured, sprinkled or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.
In 21 CFR 701.20, FDA explains the criteria articles must meet to be considered “soap” under section 201(i) of the act.
FDA is issuing these regulations under the adulteration provisions in sections 402(a)(2)(C), (a)(3), (a)(4), (a)(5), 601(c), and under section 701(a) of the act (21 U.S.C. 342(a)(2)(C), (a)(3), (a)(4), (a)(5), 361(c), and 371(a)). Under section 402(a)(3) of the act, a food is deemed adulterated “if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food.” “Otherwise unfit for food” is an independent clause in section 402(a)(3). It does not seem to require that a food be filthy, putrid, or decomposed for it to be “otherwise unfit for food.” We conclude that a food can be “otherwise unfit for food” based on health risks. We seek comments on this interpretation. Because of the discovery of a BSE positive cow in the United States and the possibility of disease transmission to humans from exposure to material from infected cattle, prohibited cattle materials (SRMs, small intestine of all cattle, MS(Beef), material from nonambulatory disabled cattle, and material from cattle not inspected and passed) may present a risk to human health. Under our interpretation of section 402(a)(3), these materials are unfit for food. Under section 402(a)(4) of the act, a food is adulterated “if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.” The failure to ensure that food is prepared, packed, or held under conditions in which prohibited cattle materials do not contaminate the food constitutes an insanitary condition whereby it may have been rendered injurious to health and thus renders the food adulterated under section 402(a)(4). Under section 402(a)(5) of the act, food is deemed adulterated if “* * * it is, in whole or in part, the product * * * of an animal which has died otherwise than by slaughter.” Some cattle are not inspected and passed because they have died before slaughter. Material from these cattle that die otherwise than by slaughter is adulterated under section 402(a)(5).
We are also relying on the food additive provision in section 402(a)(2)(C) of the act. Any substance whose intended use results or may reasonably be expected to result in it becoming a component of food is a food additive unless, among other things, it is the subject of a prior sanction (explicit approval for a specific use by USDA or FDA prior to September 6, 1958), or is generally recognized as safe (GRAS). The regulations under 21 CFR 181.1(b) provide that, if scientific data or information shows that the use of a prior-sanctioned ingredient may be injurious to health and, thus, in violation of section 402 of the act, FDA can prohibit use of the ingredient in food. Prior sanctions are described in 21 CFR part 181. FDA is not aware of any prior sanctions that relate to the present use of prohibited cattle materials. However, to the extent any prior sanctions exist for the use of prohibited cattle materials in food, they are hereby revoked.
A determination that a substance added directly or indirectly to a food is GRAS for its intended use is generally based on specific information regarding the composition of the substance, its use, method of preparation, methods for detecting its presence in food, and information about its functionality in food as determined by experts qualified by scientific training and experience to evaluate the safety of such a substance (21 CFR 170.35). A substance added to food becomes GRAS as a result of a common understanding about the substance throughout the scientific community familiar with the safety of such substances. The basis of expert views may be either scientific procedures, or, in the case of a substance used in food prior to January 1, 1958, experience based on common use in food (§ 170.30(a)) (21 CFR 170.30(a)). Substances that are GRAS based on use prior to January 1, 1958, must be currently recognized as safe based on their pre-1958 use (See
General recognition of safety based upon scientific procedures requires the same quantity and quality of scientific evidence as is required to obtain approval of a food additive regulation for the ingredient (§ 170.30(b)). (See
Expert opinion that prohibited cattle materials are GRAS would need to be supported by scientific literature, and
For the reasons discussed in section I of this document, the agency is declaring that prohibited cattle materials are not GRAS by qualified experts for use in human food and, therefore, are food additives. Section 402(a)(2)(C) of the act deems food adulterated “if it is, or it bears or contains, any food additive which is unsafe within the meaning of section 409 * * *.” Under section 409(a) (21 U.S.C. 348(a)), a food additive is unsafe unless a food additive regulation or an exemption is in effect with respect to its use or its intended use. As a result, because neither a food additive regulation, nor an exemption, is in effect for prohibited cattle materials intended for use in human food, such materials, with the exception of dietary ingredients in dietary supplements, are adulterated under section 402(a)(2)(C) of the act, and their presence in food renders the food adulterated.
Dietary supplements are considered food under the act and are included in this rule. However, the food additive definition in section 201(s)(6) of the act exempts from regulation as a food additive “an ingredient described in paragraph (ff) in, or intended for use in, a dietary supplement.” An ingredient described in section 201(ff) is a dietary ingredient. Therefore, a dietary ingredient, within the meaning of section 201(ff), is not subject to regulation as a food additive. FDA notes that, under this rule, ingredients containing prohibited cattle materials, and dietary supplements containing such ingredients, would be adulterated food under section 402(a)(3) and (a)(4) of the act, as unfit for food and as food prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. Such dietary ingredients would also be adulterated under section 402(a)(5) of the act if sourced from an animal that died other than by slaughter.
Under section 601(c) of the act, a cosmetic is adulterated “if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.” The failure to ensure that a cosmetic is prepared, packed, or held under conditions in which prohibited cattle materials do not contaminate the cosmetic constitutes an insanitary condition whereby it may have been rendered injurious to health and, thus, renders the cosmetic adulterated under section 601(c).
Under section 701(a) of the act, FDA is authorized to issue regulations for the act's efficient enforcement. A regulation that requires measures to prevent human food from being unfit for food, from being or bearing an unsafe food additive, from being the product of an animal that died otherwise than by slaughter, and to prevent human food and cosmetics from being held under insanitary conditions, allows for efficient enforcement of the act. The regulations require that manufacturers and processors of human food and cosmetics that are manufactured from, processed with, or otherwise contain, material from cattle make existing records available to FDA for inspection and copying. Once material is removed from cattle, we may not be able to obtain the information necessary to determine whether it is prohibited cattle material. For example, we would not know from examination of a spinal cord whether the source animal was over 30 months of age at the time of slaughter or whether it was inspected and passed. Therefore, the records access requirement is necessary for the efficient enforcement of this rule. Failure to comply with this rule's records access requirement renders the affected food and cosmetics adulterated under sections 402(a)(4) and 601(a) respectively.
We are issuing this rule as an interim final rule, effective immediately, with an opportunity for public comment. Section 553(b)(3)(B) of the Administrative Procedure Act (5 U.S.C. 553(b)(3)(B)) provides that, when an agency for good cause finds that notice and public procedure are impracticable, unnecessary, or contrary to public interest, the agency may issue a rule without providing notice and public comment. FDA has determined that there is good cause under 5 U.S.C. 553(b)(3)(B) and 21 CFR 10.40(d) because the discovery of BSE in a cow in the United States requires regulations in place immediately to impose restrictions on the use of cattle material in human food and cosmetics to further reduce the possibility of transmission of vCJD. Further, under 5 U.S.C. 553(d)(3), we find good cause to make the rule effective immediately. It is imperative that we act quickly to impose these restrictions on the use of cattle material in human food and cosmetics to further reduce the possibility of transmission of vCJD and ensure that there is consistent protection of the U.S. food supply by imposing upon FDA-regulated products the same restrictions related to BSE imposed upon USDA-regulated products.
FDA invites public comment on this interim final rule. The comment period on this interim final rule will be 90 days. The agency will consider modifications to this interim final rule based on comments made during the comment period. Interested persons may submit to the Division of Dockets Management (see
This interim final rule applies to human food and cosmetics manufactured from, processed with, or that otherwise contain, material from cattle slaughtered on or after its effective date. Human food and cosmetics under the act include their components and the rule applies to these components. FDA realizes that it may be difficult, in certain instances, for manufacturers and processors to comply immediately with all of the provisions of this interim final rule. We may consider this in enforcing the rule.
FDA will address comments received and confirm or amend this interim final rule in a final rule.
FDA has examined the economic implications of this interim final rule as required by Executive Order 12866. 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;
The FSIS' interim final rule requires that specified risk materials, small intestine from all cattle, tissue from nonambulatory disabled cattle, and MS(Beef) not be used for human food. Specified risk materials include the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse process of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months and older, and the tonsils and distal ileum of the small intestine of all cattle. The FSIS interim final rule requires that all of the prohibited materials be destroyed or sent to inedible rendering.
FDA, in response to the finding of an adult cow that tested positive for BSE in the State of Washington and to be consistent with the USDA in regulating cattle products that could potentially transmit BSE, is issuing this interim final rule for FDA-regulated food and cosmetics that may contain cattle material of concern. Specifically, this interim final rule regulates cattle materials that may be used in human foods (e.g., dietary supplements, food additives, color additives, infant formula) and cosmetics.
This interim final rule will not affect the incidence of BSE in cattle, which is addressed in other FDA regulations. This interim final rule will serve as a safeguard to reduce human exposure to the agent that causes BSE that may be present in cattle-derived products from domestic and imported sources. If BSE-infected cattle or cattle material is prevented from use in human food by the requirements in this rule (e.g., the requirement that cattle materials be sourced from inspected and passed animals) this interim final rule will reduce human risk by reducing human exposure to infectious materials (i.e., prohibited cattle materials).
This interim final rule prohibits the use of “prohibited cattle materials.” These include SRMs (brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse process of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months and older (including rendering of these materials), and the tonsils and distal ileum of the small intestine of all cattle), small intestine of all cattle, tissue from nonambulatory disabled cattle, tissue from cattle not inspected and passed for human consumption, and MS(Beef) in all FDA-regulated human food and cosmetics.
Under this interim final rule, tallow with no more than 0.15 percent hexane-insoluble impurities or that meets the requirements of § 189.5(b) (human food) or § 700.27(b) (cosmetics) may be used in food or cosmetics. In addition, tallow derivatives are exempt from the requirements of this rulemaking. The provisions for tallow and tallow derivatives in this interim final rule are in accordance with the best guidance from the OIE and FDA's TSEAC. The interim final rule provides in §§ 189.5(c) and 700.27(c) that manufacturers and processors of human food or cosmetics that are manufactured from, processed with, or otherwise contains cattle material must make records relevant to compliance with this rule available to FDA for inspection and copying.
In response to the concern over BSE in food and cosmetics, FDA considered three regulatory options:
• No new regulation (baseline).
• Prohibit the use of prohibited cattle materials in human food and cosmetics and require access to existing records relevant to determine compliance.
• Prohibit the use of prohibited cattle materials in human food and cosmetics and require establishment, maintenance, and access to records demonstrating that prohibited cattle materials are not used in human food and cosmetics.
This option would prohibit the use of prohibited cattle materials in all FDA-regulated food, including dietary supplements, and cosmetics, and would require that manufacturers and processors make existing records related to compliance with the rule available to FDA for inspection and copying.
The prohibition would cover the same materials prohibited by the FSIS interim final rule and also materials from cattle that are not inspected and passed for human consumption. Because SRMs, small intestine of all cattle, nonambulatory disabled cattle and MS(Beef) are subject to the USDA's disposition requirements (e.g., destruction or rendering for purposes other than human food), we assume that generally these materials are not likely to be widely available for use in the manufacture of FDA-regulated human food and cosmetics. The manufacturers and processors of products currently using materials that are considered SRMs (e.g., the brain, skull, spinal cord) would presumably be able to continue to use these ingredients, but exclusively from cattle younger than 30 months of age. The manufacturers of FDA-regulated human food products that use rendered material would continue to use rendered material that is the product of edible rendering (e.g., edible tallow). The manufacturers and processors of products using the tonsils and the small intestine of all cattle, material from nonambulatory disabled cattle, material from cattle not inspected and passed for human consumption, and MS(Beef) would need to find substitutes for these ingredients. We assume that the recent USDA rulemaking has already led many of these manufacturers to search for alternative ingredients.
We do not have adequate information to quantify the cost of ingredient switching for human foods and request data on this subject. To the extent that this option leads to increased use of alternative ingredients, exposure to prohibited cattle materials will be reduced. Without a complete records requirement, however, the incentives to ensure that alternative ingredients are used are reduced. Access to existing records, as required by this option, would not increase the costs of this interim final rule, but would be beneficial in ensuring that acceptable cattle material is used in the manufacture of food and cosmetics.
Manufacturers of cosmetics that currently use inedible rendered materials, including tallow containing more than 0.15 percent hexane-insoluble impurities, would have to find alternative ingredients. We assume that they would switch to edible cattle rendered material, or perhaps non-cattle inedible rendering, to continue production. While we do not have
Because edible cattle material is more expensive than inedible material, the costs for inputs into cosmetic production would increase for those producers that currently use inedible cattle material and must switch to edible cattle material. FDA does not have information on the specific number of ingredient substitutions that will be made in cosmetics production as a result of this interim final rule. We assume that the increased costs of edible cattle material as an ingredient in cosmetic production would, at least in part, be passed along to cosmetics' consumers in the form of higher prices for finished products. It is unlikely that the price increases for the cosmetic inputs or for the finished products would be large enough to substantially decrease the amounts of the affected products sold. FDA requests comments on this assumption.
Even though FDA does not have a specific list of cosmetics that currently use inedible rendering as an input in production, we do have information from the year 2000 on the U.S. consumption of inedible tallow and greases used in soap, lubricants, and fatty acids (Ref. 53). We expect that these three ingredients represent a good portion of the inedible rendering that is used to produce cosmetics.
Tallow is the generally accepted term for the rendered fat from ruminant carcasses, while grease is a more generic term that could be used to describe rendered pork fat (white grease), used restaurant grease (yellow grease), or lower quality tallow (also called yellow grease). To estimate the portion of inedible tallow from cattle in the inedible tallow and greases category, we looked at the percentage of total production of inedible tallow and greases that represented inedible tallow for the year 2000, and found that inedible tallow represented 54 percent of the mixture.
Table 1 of this document shows the usage of inedible tallow and greases by category (soap, lubricant, or fatty acid), the consumption that represents the cattle portion of the material (inedible tallow) and the calculated additional costs—about $18 million—of these potential cosmetic inputs. The cost of cosmetic ingredient switching shown in table 1 represents an upper bound estimate of costs. Some cosmetic products likely use tallow derivatives, exempt from this rulemaking, or already use cattle-derived ingredients that are considered edible. Because we do not have precise information on how many cosmetic products use tallow with more than the maximum level of insoluble impurities or other inedible cattle material as ingredients, we estimate the costs of cosmetic ingredient switching to be between $0 and $18 million.
Regulatory option 2 would decrease the likelihood of human exposure to BSE in several ways. First, by making clear that prohibited cattle material cannot be used in FDA-regulated human food and cosmetics, option 2 would create an additional regulatory barrier, beyond existing regulations, between consumers and food and cosmetics potentially contaminated with BSE. Second, by deeming human food and cosmetics manufactured from, processed with, or otherwise containing, prohibited cattle materials to be adulterated, option 2 would clarify FDA's ability to prohibit importation of prohibited cattle materials. Imported products, such as gelatin, beef extracts, and dietary supplements, may contain the types of materials prohibited by the USDA, but may not fall under the scope of the USDA's import restrictions.
The benefits of this interim final rule are the value of the public health benefits. The public health benefit is the reduction in the risk of the human illness associated with consumption of the agent that causes BSE.
If we define the baseline risk as the expected annual number of cases of vCJD per year, then the annual benefits of prohibiting prohibited cattle materials for use in foods and cosmetics would be:
(baseline annual cases of vCJD - annual cases of vCJD under FDA interim final rule) x (value of preventing a case of vCJD).
An alternative way to characterize benefits is:
Reduction in annual cases in vCJD under FDA interim final rule x (value of preventing a case of vCJD)
We do not know the baseline expected annual number of cases, but based on the epidemiology of vCJD in United Kingdom we anticipate much less than one case of vCJD per year in the United States. Because the interim final rule will reduce rather than eliminate risk of exposure to BSE infectious materials, the reduction in the number of cases will be some fraction of the expected number. The value of preventing a case of vCJD is the value of a statistical life plus the value of preventing a year-long or longer illness that precedes certain death for victims of vCJD. In a recent rulemaking regarding labeling of trans fatty acids (68 FR 41433, July 11, 2003), we used a range of $5 to $6.5 million for the value of a statistical life. The value of preventing a vCJD case would be even higher because of the significant medical costs associated with the illness (Ref. 54). We estimate that the value of preventing a single case of vCJD ranges
As discussed earlier in this document, the Harvard-Tuskegee study has stated that a ban on specified risk materials, including cattle brains, spinal cord and vertebral column, from inclusion in human and animal food would reduce the very few potential BSE cases in cattle by a further 88 percent and potential human exposure to infectivity in meat and meat products by a further 95 percent. This interim final rule, in conjunction with the USDA's interim final rule, will help achieve this reduction in potential human exposure. This interim final rule will also reduce potential human exposure to BSE infection in human food not covered by the Harvard-Tuskegee study. For example, this interim final rule will help ensure that a domestically produced or foreign-produced dietary supplement or ingredient contains cattle material (e.g., brain) from animals of an appropriate age.
The social cost of this interim final rule, which we approximate by multiplying the difference in ingredient prices by the pre-regulation quantity of ingredients, will be borne by producers and consumers of affected products. If demand is inelastic compared with supply, consumers will bear most of the social cost. If supply is inelastic compared with demand, producers will bear most of the social cost. The ready availability of alternatives for the prohibited ingredients, and the small number of products currently using them, implies that the social costs of this rule will likely be small for foods. The social costs for cosmetics will be greater. We estimate that the cost of ingredient switching for cosmetics will range from a lower bound of $0 to an upper bound of $18 million. The benefit of this interim final rule is that its requirements will—by reducing exposure to potentially infective materials—provide a safeguard against a case of vCJD occurring in humans if cattle infected with BSE enter the human food or cosmetic supply.
Option 3, like option 2, prohibits the use of prohibited cattle materials in human food, including dietary supplements, and cosmetics. We explained in the discussion of option 2 that the USDA's prohibitions are not sufficient, by themselves, to ensure that prohibited cattle materials are not used in FDA-regulated food and cosmetics. Therefore, FDA must be able to determine whether prohibited cattle materials are used in the human food and cosmetics it regulates. Option 3 requires manufacturers and processors of FDA-regulated human food and cosmetics manufactured from, processed with, or otherwise containing cattle material to establish, maintain, and provide access to records documenting that prohibited cattle materials are not used in their products. Under this option, records would not be not required for human food or cosmetics containing tallow derivatives because tallow derivatives are not prohibited cattle material. The marginal difference between options 2 and 3 presented in this interim final rule is the requirements to establish and maintain records for cattle-derived materials in Option 3. The requirement of records for cattle-derived materials is the subject of an FDA proposed rulemaking published elsewhere in this issue of the
Without these records, FDA may not be able to determine the age of cattle material, such as brain or spinal cord, once it is separated from the source animal. In addition, without records, the agency may not be able to determine the inspectional status of the source animals. This regulatory option would require that the manufacturer or processor retain records for 2 years after using cattle material in food or cosmetics. Records must be kept at the manufacturing or processing establishment or another reasonably accessible location.
The costs of option 3 are the $0 to $18 million ingredient switching costs calculated for option 2, plus the recordkeeping costs. We assume that some records must be created for each shipment of materials from a slaughterhouse or rendering facility to an FDA-regulated facility. We also assume that all supporting information is known by the slaughter or rendering facility. The USDA's interim final rule requires that establishments that slaughter cattle or that process the carcasses or parts of carcasses of cattle maintain daily records sufficient to document the implementation and monitoring of procedures for removal, segregation, and disposition of SRMs.
Although most FDA-regulated human food does not use a large quantity of cattle material, certain products contain substantial amounts. Some fats and oils (e.g., oleo margarine and shortening) use edible tallow and its derivatives; ice cream, yogurt, candies, flavorings, marshmallows, and mayonnaise use gelatin; and some soups, mixed entrees, cake mixes and pasta use a range of cattle material (Refs. 55 and 56).
Using establishment data from the FDA Small Business Model (which includes information on all establishments in a manufacturing sector regardless of size) (Ref. 57), FDA estimated that 132 establishments produce fats and oils, 181 establishments produce spreads, 127 establishments produce flavoring extracts, 40 establishments produce canned soups and stews, 625 establishments produce non-chocolate candy, 88 establishments produce yogurt, and 451 establishments produce ice cream. FDA cannot verify that all of these establishments actually use cattle materials that fall under the jurisdiction of this interim final rule; many may not. It is likely that all of the 132 establishments that produce fats and oils currently use tallow derivatives, not tallow, so FDA assumes that no records would be required to be kept by this establishment group. We assume that only 25 percent of the establishments from the remaining production sectors listed previously actually produce human food that is manufactured from, processed with, or otherwise contains material from cattle and therefore would be required to keep records under this option. We include only 25 percent of the establishments in our estimates because most of the manufacturers likely do not use cattle-derived ingredients in their products. FDA requests comments on this assumption.
FDA research shows that 25 establishments with U.S. addresses supply cattle-derived ingredients that are used in cosmetics (Ref. 58). These cattle-derived ingredients include albumin, brain extract, brain lipids, cholesterol and cholesterol compounds, fibronectin, sphingolipids, spleen extract, tallow, and keratin and keratin compounds. FDA research also shows that 22 foreign establishments may export these cattle-derived ingredients to U.S. cosmetic manufacturers. The U.S. cosmetic manufacturers would be required to obtain records from the foreign establishments under this
FDA does not have enough information on the types of cattle material used by the 47 domestic and foreign cosmetics establishments to know how often tallow derivatives (exempt from the definition of prohibited cattle materials and, therefore, exempt from the requirements under this option) are the only cattle-derived ingredient used in these products. We estimate that 75 percent (or 35) of the 47 cosmetics establishments would have to keep records for their cattle-derived ingredients. We estimate that only 75 percent will keep records because many cosmetics use tallow derivatives as their only cattle-derived material and such materials are exempt from this rulemaking. FDA requests comments on this assumption.
From FDA's dietary supplement database (Ref. 62), we are able to tell that there are 162 dietary supplement brand names that use cattle material as ingredients in their products. We assume that each brand name represents a facility that produces multiple dietary supplement products containing cattle-derived ingredients; therefore we assess recordkeeping costs for all 162 brand names. We do not have information to determine if any of the dietary supplement manufacturers use tallow derivatives (exempt from all requirements under this option) as their only cattle-derived ingredient.
The USDA's BSE interim final rule requires those establishments that slaughter cattle or that process the carcasses or parts of carcasses of cattle maintain daily records sufficient to document the implementation and monitoring of procedures for removal, segregation, and disposition of SRMs. This USDA requirement would reduce the startup costs of the recordkeeping required under this option.
Recordkeeping costs include one-time costs and recurring costs. One-time costs include the costs of designing records and training personnel in the maintenance of the records. The recurring costs are the costs of ensuring that appropriate records document the absence of prohibited cattle risk materials in human food and cosmetics. The costs of retaining records and planning for an FDA request for records access are estimated to be zero. We estimate these costs to be zero becasue current business practices already dictate that records for a second year is assumed to be greater than the marginal cost of doing so. Although there is no specific time period for providing records when requested, FDA notes that records requestes costs are zero when FDA gives the records submitter 24 hours to comply. These cost estimates are consistent with cost estimates used in FDA's proposed recordkeeping requirements in “Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002” (68 FR 25188, May 9, 2003).
We assume that the one-time training burden incurred for each facility is the equivalent of 1 month's on-the-job training or approximately 1/3 of an hour. This time includes both the training required for personnel to learn how to verify that shipments contain the appropriate records, and also the training required for personnel to learn how to file and maintain those records. Given current business practices, we know personnel are familiar with recordkeeping. Therefore, the requirement to maintain additional records is expected to be learned quickly. This training burden for recordkeeping is consistent with the recordkeeping training burden in the analysis for the proposed recordkeeping rule (68 FR 25188; May 9, 2003) and the records maintenance burden used in the analysis of the Juice HACCP rule (66 FR 6138; January 19, 2001). Consistent with the analysis conducted for the proposed recordkeeping rule (68 FR 25188; May 9, 2003), FDA assumes an hourly cost of an administrative worker, $25.10 per hour, which has been doubled from $12.55 wage per hour to include overhead costs. This cost, $25.10 per hour, applies to all labor costs.
We use the FDA Labeling Cost Model to estimate the one-time records design costs per facility of $1,190 per stockkeeping unit (SKU) (Ref. 63). It is likely that facilities using cattle-derived ingredients, whether the ingredients are for human food or cosmetics, will take advantage of their economies of scope and produce more than one product with these ingredients. It is probable that each establishment has several SKUs associated with products containing cattle-derived ingredients that will now require recordkeeping. To account for additional products and SKUs we multiply the record design costs per facility by 1.5 for a total design cost per facility of $1,785 ($1,095 in labor costs and $690 in capital costs).
We multiplied the cost per product per SKU by 1.5 to account for the additional records design required for the additional SKUs. The record design cost for the first affected product or SKU will be more expensive than the marginal cost of adding records for additional SKUs. This marginal cost of record design for additional SKUs could be negligible or it could come close to doubling the costs; we therefore pick 1.5, the midpoint of one and two, to be the cost multiplier.
Consistent with the analysis conducted for the proposed recordkeeping rule implementing the 2002 Bioterrorism Act, this record design cost is assumed to be shared between two facilities—the upstream facility and the downstream facility—as both will need to be involved in record production that meets the needs of both the supplier and customer for the cattle-derived ingredient.
Unlike the Bioterrism Act proposed recordkeeping rule, we do not have direct information on all the facilities covered; we do not have data on the number of slaughter plants or renderers that supply cattle material for human food and cosmetic manufacturers and processors under FDA jurisdiction. FDA does, however, have some information on the number and type of downstream facilities that receive this material. Using information on the number of human food and cosmetic manufacturers that may use cattle-derived ingredients subject to this interim final rule, we can account for the total shared records costs by assuming that each food manufacturer or processor facility listed in the table below procures ingredients from one upstream slaughter plant or renderer. We assume each manufacturing facility maintains an exclusive contractual relationship with one ingredient supplier for calculation purposes. Even if multiple input suppliers are utilized by the manufacturing facility, the marginal record set-up costs would decrease for additional suppliers. Once the facility has learned what records are required, it is less costly to keep records on additional input suppliers. FDA requests comment on this assumption.
Information on food producing facilities in Table 2 represent U.S. facilities; dietary supplement numbers account for both domestic and foreign facilities; cosmetics numbers account
The recurring recordkeeping cost is the cost of ensuring that appropriate records document the absence of prohibited cattle materials in human food and cosmetics.
The framework for estimating the amount of time required for FDA-regulated facilities to ensure that the records for each shipment of materials is based on the regulatory impact analysis of the proposed recordkeeping requirements in “Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.” In that analysis we estimated that 30 minutes per week would be required to ensure that records on each shipment to and from a facility contain adequate information of the contents of the package, as well as adequate information on the transporter, supplier, and receiver.
The recordkeeping requirements of this regulatory option will cover only a small fraction of all ingredients used in the human food and cosmetic manufacturing processes and only require that records of cattle-derived ingredient origin from the input supplier be verified and maintained by a food or cosmetic manufacturer or processor. Because this recordkeeping requirement is less complex than the recordkeeping requirements under the Bioterrorism Act and affects fewer ingredients, we estimate the per facility burden to be about one-half of the burden estimated for the Bioterrorism Act recordkeeping rule (68 FR 25188, May 9, 2003): 15 minutes per week, or 13 hours per year. FDA assumes that this recordkeeping burden will be shared between two entities (i.e., the slaughter plant and the manufacturer or processor of finished products containing cattle-derived ingredients).
Table 3 shows the recurring recordkeeping costs for human food and cosmetic manufacturers and processors. As stated earlier, information on food producing facilities in Table 3 represents U.S. facilities; dietary supplement numbers account for both domestic and foreign facilities; cosmetics numbers account for both domestic and foreign input suppliers.
The benefits of this option are the same as the benefits of option 2—the value of the public health benefits. The public health benefit is the reduction in the risk of the human illness associated with consumption of the agent that causes BSE. With this option, however, requiring the establishment and maintenance of records provides an additional safeguard to prevent exposure to potentially infected materials.
FDA has examined the economic implications of this interim final rule as required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a rule has a significant economic impact on a substantial number of small entities, the Regulatory Flexibility Act requires agencies to analyze regulatory options that would lessen the economic effect of the rule on small entities. FDA does not believe that this interim final rule will have a significant economic impact on a substantial number of small entities.
For this interim final rule, the only cost is for those human food and cosmetic facilities that will need to switch to alternative ingredients. While food facilities may incur search costs as well as higher ingredient costs, the ready availability of alternatives for prohibited ingredients, and the small number of products currently using them, implies that these costs will be negligible for foods.
Cosmetic facilities are more likely than food facilities to experience substantial ingredient switching costs as a result of this interim final rule. As shown previously, we estimate that 35 cosmetics establishments will be affected by this interim final rule. If ingredient switching costs are closer to FDA's estimated upper bound of $18 million than to the lower bound of 0, the average cost per establishment will be about $500,000. We do not know if any of the affected establishments are small businesses. This cost would, however, be a significant economic impact for small cosmetics businesses. If the actual costs are closer to the lower bound, then the economic impact will not be significant.
Because switching ingredients is the source of the reduction in exposure to potentially infective materials, it is necessary to apply the rule's provisions to all establishments equally. We have, however, allowed small businesses some flexibility by not requiring the establishment and maintenance of records in this interim final rule. In a companion rulemaking, we propose record establishment and maintenance requirements and ask for comments on their effect on small businesses.
Title II of the Unfunded Mandates Reform Act of 1995 (Public Law 104-4) requires cost-benefit and other analyses before any rulemaking if the rule would include a “Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any 1 year.” The current inflation-adjusted statutory threshold is $115 million. FDA has determined that this interim final rule does not constitute a significant rule under the Unfunded Mandates Reform Act.
The Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121) defines a major rule for the purpose of congressional review as having caused or being likely to cause one or more of the following: An annual effect on the economy of $100 million or more; a major increase in costs or prices; significant adverse effects on competition, employment, productivity, or innovation; or significant adverse effects on the ability of U.S.-based enterprises to compete with foreign-based enterprises in domestic or export markets. In accordance with the Small Business Regulatory Enforcement Fairness Act, the Office of Management and Budget (OMB) has determined that this interim final rule is not a major rule for the purpose of congressional review.
This interim final rule does not contain information collection provisions that are subject to review by the OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Therefore, clearance by OMB under the Paperwork Reduction Act of 1995 is not required.
FDA has carefully considered the potential environmental effects of this interim final rule and of three possible alternative actions. In doing so, the agency focused on the environmental impacts of its action as a result of disposal of unused cattle byproducts (e.g., dead animals and slaughter byproducts) that need to be handled after the rule becomes effective.
The environmental assessment (EA) considered each of the alternatives in terms of the need to provide maximum reasonable protection of human health without resulting in a significant impact on the environment. The EA considered environmental impacts related to landfill, incineration, composting, and land burial. The additional waste that might result from the selected action would be an extremely small amount compared to the total amount of waste generated by the cattle industry.
The agency has concluded that the interim final rule will not have a significant impact on the human environment, and that an environmental impact statement is not required. FDA's finding of no significant impact (FONSI) and the evidence supporting that finding, contained in an EA prepared
We have analyzed this interim final rule in accordance with the principles in Executive Order 13132. We have determined that the interim final rule does not contain policies that have substantial direct effects on the states, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we have concluded that the interim final rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement has not been prepared.
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24. Lasmezas, C.I., J-G. Fournier, V. Nouvel, et al., “Adaptation of the Bovine Spongiform Encephalopathy Agent to Primates and Comparison With Creutzfeldt-Jakob Disease: Implications for Human Health,”
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Food additives, Food packaging, Incorporation by reference.
Cosmetics, Packaging and containers, Incorporation by reference.
21 U.S.C. 321, 342, 348, 371.
(a)
(1)
(2)
(3)
(4)
(5)
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(2) Human food manufactured from, processed with, or otherwise containing, prohibited cattle materials is unfit for human food and deemed adulterated under section 402(a)(3) of the act.
(3)
21 U. S. C. 321, 331, 352, 355, 361, 362, 371, 374.
(a)
(1)
(2)
(3)
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Food and Drug Administration, HHS.
Proposed rule.
The Food and Drug Administration (FDA) is proposing to require that manufacturers and processors of human food and cosmetics that are manufactured from, processed with, or otherwise contain, material from cattle must establish and maintain records sufficient to demonstrate the food or cosmetic is not manufactured from, processed with, or does not otherwise contain, prohibited cattle materials. This is a companion rulemaking to FDA's interim final rule entitled “Use of Materials Derived From Cattle in Human Food and Cosmetics,” published in this issue of the
You may submit written or electronic comments on the proposed rule by August 13, 2004. Submit written comments on the information collection requirements by August 13, 2004.
You may submit comments, identified by Docket No. 2004N-0257, by any of the following methods:
• Federal eRulemaking Portal:
• Agency Web site:
• E-mail:
• FAX: 301-827-6870.
• Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
OMB is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officer for FDA, FAX: 202-395-6974.
Rebecca J. Buckner, Center for Food Safety and Applied Nutrition (HFS-306), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1486.
In this issue of the
In this companion rulemaking, we are proposing that manufacturers and processors of human food and cosmetics that are manufactured from, processed with, or otherwise contain, material from cattle must establish and maintain records sufficient to demonstrate the food or cosmetic is not manufactured from, processed with, or does not otherwise contain, prohibited cattle materials. We believe that records documenting the absence of prohibited cattle materials in human food and cosmetics are critical for manufacturers, processors, and FDA to ensure compliance with the ban on the use of prohibited cattle materials in the interim final rule. Once material is removed from cattle, we may not be able to obtain the information necessary to determine whether it is prohibited cattle material. There is currently no way to test reliably for the presence of the bovine spongiform encephalopathy (BSE) agent or for the presence of prohibited cattle materials. Therefore, manufacturers and processors of human food and cosmetics must depend on records from the suppliers of cattle material to demonstrate that the supplier's cattle material does not contain prohibited cattle materials.
Through these records, manufacturers and processors of human food and cosmetics can ensure that prohibited cattle materials are not included in their products. The agency believes that recordkeeping and records access requirements are necessary immediately. The agency recognizes, however, that recordkeeping systems cannot be put into place immediately and, therefore, to include recordkeeping requirements in the interim final rule could result in manufacturers and processors immediately being in violation of the adulteration provisions of the Federal Food, Drug, and Cosmetic Act (the act) with respect to food and cosmetics because of their failure immediately to establish and maintain the necessary records as of the effective date of the interim final rule. For that reason, we are proposing record establishment and maintenance
The following definitions are from the interim final rule (new §§ 189.5(a) and 700.27(a) (21 CFR 189.5(a) and 700.27(a))) and are included here because they are relevant to the proposed recordkeeping provisions:
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We are proposing in §§ 189.5(c)(1) and 700.27(c)(1) that manufacturers and processors of human food and cosmetics that are manufactured from, processed with, or otherwise contain, material from cattle establish and maintain records that demonstrate that the material from cattle meets the requirements of the interim final rule. Because there is currently no way to test reliably for the presence of the BSE agent or for the presence of prohibited cattle materials, manufacturers and processors of human food and cosmetics must depend on records from the suppliers of cattle material to demonstrate that their source material is free from prohibited cattle material. Similarly, without adequate records, FDA may not know whether manufacturers and processors of human food and cosmetics have complied with the prohibitions against the use of prohibited cattle materials. Therefore, we are proposing under §§ 189.5(c)(1) and 700.27(c)(1) that manufacturers and processors of human food and cosmetics that are manufactured from, processed with, or otherwise contain, material from cattle must establish and maintain records sufficient to demonstrate that the human food and cosmetics do not contain prohibited cattle materials and that such records must be made available to FDA for inspection and copying.
For example, to satisfy the requirement in §§ 189.5(c)(1) and 700.27(c)(1) of this proposed rule that records must show the absence of specified risk materials, manufacturers and processors of human food and cosmetics that are manufactured with, processed from, or otherwise contain, brain from cattle would have to establish and maintain records to demonstrate, among other things, that the human food or cosmetic was not manufactured with, processed from, or does not otherwise contain, brain from cattle over 30 months of age.
In general, we would expect a manufacturer or processor of FDA-regulated human food or cosmetics containing cattle material (e.g., soup containing beef broth, dietary supplements containing cattle brain powder) to have the following types of records:
• A signed and dated affirmation (with contact information) by the slaughter establishment that cattle material supplied by that establishment in a particular shipment does not contain prohibited cattle materials. If lots of cattle material from different slaughter establishments are pooled into a final product, then a manufacturer or processor would need to maintain records from each slaughter establishment.
• For human food and cosmetics containing tallow, a manufacturer or processor would need to maintain records from a slaughter establishment affirming that the tallow was produced from material containing no prohibited cattle materials or similar records (i.e., signed, dated, with contact information) from the tallow supplier affirming that the tallow contains no more than 0.15 percent hexane-insoluble impurities.
We request comments on other ways in which the proposed recordkeeping requirements might be satisfied. We also request comments on whether existing recordkeeping practices include the required information and, if not, what changes the proposal would necessitate.
We note that USDA is working toward the establishment of a national database for animal identification, which should make maintaining information about source animals less burdensome.
We are proposing in §§ 189.5(c)(2) and 700.27(c)(2) that records be retained for 2 years after the date the records were created. We acknowledge that USDA in its BSE interim final rule is requiring that records be retained for 1 year. However, FDA-regulated human food, such as canned and dried foods and dietary supplements and cosmetics have a longer shelf life than most USDA-regulated products, which are primarily fresh meat. It is important for traceback and recall purposes that records be retained for the likely shelf life of the product. As discussed previously, records documenting the absence of prohibited cattle materials in human food and cosmetics are necessary to help FDA ensure compliance with the requirements of the interim final rule. It is important for the records to be kept during the shelf life of these products, so that FDA can ensure that products on the market are not adulterated. Therefore, we have tentatively concluded that records must be retained for 2 years.
We are proposing in §§ 189.5(c)(3) and 700.27(c)(3) that records be maintained at the manufacturing or processing establishment or at a reasonably accessible location. Proposed §§ 189.5(c)(4) and 700.27(c)(4) provide that maintenance of electronic records is acceptable and that electronic records are considered to be reasonably accessible if they are accessible from an onsite location.
Proposed §§ 189.5(c)(5) and 700.27(c)(5) provide that records required by this subpart must be available to FDA for inspection and copying.
Because we do not necessarily have access to records maintained at foreign establishments, we are proposing in §§ 189.5(c)(6) and 700.27(c)(6), respectively, that importers must electronically affirm their compliance with the recordkeeping requirements in §§ 189.5(c)(1) and 700.27(c)(1), respectively, at the time of entry into the United States of human food or cosmetics manufactured from, processed with, or otherwise containing, material from cattle and must provide the required records within a reasonable time if requested. The records we would expect are similar to those described above for domestic products. In order for importers to electronically affirm compliance, FDA intends to modify our electronic entry system to provide a field where importers can tell us that they have the required BSE records. Proposed §§ 189.5(c)(7) and 700.27(c)(7) provide that records established or maintained to satisfy the requirements of this subpart that meet the definition of electronic records in 21 CFR 11.3(b)(6) of this chapter are exempt from the requirements of part 11 of this chapter. Under the proposed rule, records that satisfy the requirements of this subpart but that are also required under other applicable statutory provisions or regulations would remain subject to part 11 of this chapter.
Because this proposed rule is a companion rule to the interim final rule, we are issuing this proposed rule under the authorities cited in the interim final rule as well as sections 801(a) and 701(b) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 381(a) and 371(b)). As we stated in the interim final rule, FDA is issuing these regulations under the adulteration provisions in sections 402(a)(2)(C), (a)(3), (a)(4), (a)(5), 601(c), and under section 701(a) of the act (21 U.S.C. 342(a)(2)(C), (a)(3), (a)(4), (a)(5), 361(c), and 371(a)). Under section 402(a)(3) of the act, a food is deemed adulterated “if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food.” “Otherwise unfit for food” is an independent clause in section 402(a)(3). It does not seem to require that a food be filthy, putrid, or decomposed for it to be “otherwise unfit for food.” We conclude that a food can be “otherwise unfit for food” based on health risks. We seek comments on this interpretation. Because of the discovery of a BSE positive cow in the United States and the possibility of disease transmission to humans from exposure to material from infected cattle, prohibited cattle materials (SRMs, small intestine of all cattle, MS(Beef), material from nonambulatory disabled cattle, and material from cattle not inspected and passed) these materials may present a risk to human health. Under our interpretation of section 402(a)(3), these materials are unfit for food. Under section 402(a)(4) of the act, a food is adulterated “if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.” The failure to ensure that food is prepared, packed, or held under conditions in which prohibited cattle materials do not contaminate the food constitutes an insanitary condition whereby it may have been rendered injurious to health and thus renders the food adulterated under section 402(a)(4) of the act.
Under section 402(a)(5) of the act, food is deemed adulterated if “it is, in whole or in part, the product * * * of an animal which has died otherwise than by slaughter.” Some cattle are not inspected and passed because they have died before slaughter. Material from these cattle that die otherwise than by slaughter is adulterated under section 402(a)(5). We are also relying on the food additive provision in section 402(a)(2)(C) of the act. As a result, because neither a food additive regulation nor an exemption is in effect for prohibited cattle materials intended for use in human food, such materials, with the exception of dietary ingredients in dietary supplements, are adulterated under section 402(a)(2)(C) of the act and their presence in food renders the food adulterated. Under section 601(c) of the act, a cosmetic is adulterated “if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.” The failure to ensure that a cosmetic is prepared, packed, or held under conditions in which prohibited cattle materials do not contaminate the cosmetic constitutes an insanitary condition whereby it may have been rendered injurious to health and, thus, renders the cosmetic adulterated under section 601(c) of the act.
Under section 701(a) of the act, FDA is authorized to issue regulations for the act's efficient enforcement. A regulation that requires measures to prevent human food from being unfit for food, from being or bearing an unsafe food additive, from being the product of an animal that died otherwise than by slaughter, and to prevent human food and cosmetics from being held under insanitary conditions allows for efficient enforcement of the act. These proposed regulations require that manufacturers
Once material is removed from cattle, we may not be able to obtain the information necessary to determine whether it is prohibited cattle material. For example, we would not know from examination of a spinal cord whether the source animal was over 30 months of age at the time of slaughter, or whether it was inspected and passed. Because there is currently no way to test reliably for the presence of the BSE agent or for the presence of prohibited cattle materials, manufacturers and processors of human food and cosmetics must depend on records from their suppliers of cattle materials to ensure that their source material does not contain prohibited cattle materials. Without records documenting the absence of prohibited cattle materials in source materials, manufacturers and processors of human food and cosmetics cannot know whether they are adulterating their products by including prohibited cattle materials. Therefore, a failure of manufacturers and processors to establish and maintain such records results in human food and cosmetics being prepared under insanitary conditions whereby they may have been rendered injurious to health. Furthermore, without adequate records, FDA cannot know whether manufacturers and processors of human food have complied with the prohibitions against use of prohibited cattle materials. Therefore, the proposed recordkeeping requirements are necessary for the efficient enforcement of the interim final rule. Under the proposed rule, failure to comply with the recordkeeping requirements would render the affected human food and cosmetics adulterated under sections 402(a)(4) and 601(a) of the act, respectively.
We are also issuing the provisions of this proposed rule related to records regarding imported human food and cosmetics under sections 801(a) and 701(b) of the act. Section 801(a) of the act provides requirements with regard to imported food and cosmetics and provides for refusal of admission into the United States of human food and cosmetics that appear to be adulterated. Section 701(b) of the act authorizes the Secretaries of Treasury and Health and Human Services to jointly prescribe regulations for the efficient enforcement of section 801 of the act. This proposed rule sets out requirements for imported human food and cosmetics to ensure that only products that fully comply with the requirements of the interim final rule are admitted into the United States.
We are proposing that any final rule based on this proposal be effective 30 days after issuance of that final rule.
FDA invites public comment on this proposed rule. The agency will consider modifications to this proposed rule based on comments made during the comment period. Interested persons may submit to the Division of Dockets Management (see
FDA has examined the economic implications of this proposed rule as required by Executive Order 12866. 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). Executive Order 12866 classifies a rule as significant if it meets any one of a number of specified conditions, including the following conditions: Having an annual effect on the economy of $100 million, adversely affecting a sector of the economy in a material way, adversely affecting competition, or adversely affecting jobs. A regulation is also considered a significant regulatory action if it raises novel legal or policy issues. FDA has determined that this proposed rule is not an economically significant regulatory action.
USDA's BSE interim final rule requires that specified risk materials, small intestine of all cattle, tissue from nonambulatory disabled cattle, and MS(Beef) not be used for human food. SRMs include the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse process of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months and older, and the tonsils and distal ileum of the small intestine of all cattle. USDA's BSE interim final rule requires that all of the prohibited materials be destroyed or sent to inedible rendering.
FDA, in response to the finding of an adult cow, imported from Canada, that tested positive for BSE in the State of Washington and to be consistent with USDA in regulating cattle products that could potentially transmit BSE, is issuing an interim final rule for FDA-regulated human food and cosmetics that contain cattle material. This proposed recordkeeping rule is a companion to the interim final rule and responds to the same public health concerns. This proposed rule would not affect the incidence of BSE in cattle, which is addressed in other FDA regulations. This proposed rule would serve as an additional safeguard to reduce human exposure to the agent that causes BSE that may be present in cattle-derived products from domestic and imported sources.
This proposed rule would require recordkeeping to document compliance with the provisions of the interim final rule that prohibit the use of “prohibited cattle materials.” Prohibited cattle materials include SRMs (brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse process of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months and older, and the tonsils and distal ileum of the small intestine of all cattle), small intestine of all cattle, tissue from nonambulatory disabled cattle, tissue from cattle not inspected and passed for human consumption, and MS(Beef).
This proposed rule would require that manufacturers and processors of human foods and cosmetics maintain records indicating that prohibited cattle materials have not been used in the manufacture or processing of a human food or cosmetic, and make such records available to FDA for inspection
This proposed rule would require manufacturers and processors of FDA-regulated human food and cosmetics manufactured from, processed with, or otherwise containing, cattle material to maintain records demonstrating that prohibited cattle materials are not used in their products. This proposed rule would require that the manufacturer or processor retain records for 2 years after using the cattle material in food or cosmetics. Records must be kept at the manufacturing or processing establishment or another reasonably accessible location. Manufacturers and processors must provide FDA with access to the required records for inspection and copying.
a.
FDA research shows that 25 establishments with U.S. addresses supply cattle-derived ingredients that are used in cosmetics (Ref. 2). These cattle-derived ingredients include albumin, brain extract, brain lipids, cholesterol and cholesterol compounds, fibronectin, sphingolipids, spleen extract, tallow, and keratin and keratin compounds. FDA research also shows that 22 foreign establishments may export these cattle-derived ingredients to U.S. cosmetic manufacturers. These foreign establishments would be required to provide records to their U.S. cosmetic manufacturer customers. We therefore include these foreign establishments when we estimate the recordkeeping costs. Imported cosmetic products represent about 10 to 20 percent of the cosmetic products on U.S. store shelves (Refs. 3, 4, and 5). However, the burden of the interim final rule to foreign cosmetics input suppliers and manufacturers will be less than the burden on domestic cosmetics producers. The burden will be less for foreign cosmetics manufacturers because Europe currently imposes some requirements similar to this rule.
FDA does not have enough information on the precise cattle material used by the 47 domestic and foreign cosmetics establishments to know how often tallow derivatives (exempt from this proposed rulemaking) are the only cattle-derived ingredient used in these products. We estimate that 75 percent (or 35) of the 47 cosmetics establishments would have to keep records for their cattle-derived ingredients. We estimate only 75 percent will keep records because many cosmetics use tallow derivatives as their only cattle-derived material, and such materials are not covered by the recordkeeping provisions. FDA requests comments on this assumption.
From FDA's dietary supplement database (Ref. 6), we are able to tell that there are 162 dietary supplement brand names that use cattle material as ingredients in their products. We assume that each brand name represents a facility that produces multiple dietary supplement products containing cattle-derived ingredients; therefore we assess recordkeeping costs for all 162 brand names. We do not have information to determine if any of the dietary supplement manufacturers use tallow derivatives (exempt from this recordkeeping requirement) as their only cattle-derived ingredient.
b.
Recordkeeping costs include one-time costs and recurring costs. One-time costs include the costs of designing records and training personnel in the maintenance of the records. The recurring costs are the costs of ensuring that the records adequately document that the shipment of cattle materials to an FDA-regulated facility is free of prohibited cattle materials. The costs of retaining records and planning for an FDA request for records access are estimated to be zero. We estimate these costs to be zero because current business practices already dictate that records are kept for at least 1 year for tax purposes and product liability purposes; the marginal private benefit of retaining records for a second year is assumed to be greater than the marginal cost of doing so. Although there is no specific time period for providing records when requested, FDA notes that records requests costs are zero when
We assume that the one-time training burden incurred for each facility is approximately one-third of an hour. This time includes both the training required for personnel to learn how to verify that the appropriate records have been received and/or created, and also the training required for personnel to learn how to file and maintain those records. Given current business practices, we know personnel are familiar with recordkeeping; therefore, the requirement to maintain additional records is expected to be learned quickly. This training burden for recordkeeping is consistent with the recordkeeping training burden in the analysis for the Bioterrorism Act proposed recordkeeping rule (68 FR 25188; May 9, 2003) and the records maintenance burden used in the analysis of the juice HACCP rule (66 FR 6138; January 19, 2001). Consistent with the analysis conducted for the Bioterrorism Act proposed recordkeeping rule, FDA assumes an hourly cost of an administrative worker, $25.10 per hour, which has been doubled from $12.55 wage per hour to include overhead costs. This cost, $25.10 per hour, applies to all labor costs.
We use the FDA Labeling Cost Model to estimate the one-time records design costs per facility of $1,190 per stock keeping unit (SKU) (Ref. 7). It is likely that facilities using cattle-derived ingredients, whether the ingredients are for human food or cosmetics, will take advantage of their economies of scope and produce more than one product with these ingredients. It is probable that each establishment has several SKUs associated with products containing cattle-derived ingredients that will now require recordkeeping. To account for additional products and SKUs we take the record design costs per facility times 1.5 for a total design cost per facility of $1,785 ($1,095 in labor costs and $690 in capital costs).
We multiplied the cost per product per SKU by 1.5 to account for the additional records design required for the additional SKUs. The record design cost for the first affected product or SKU will be more expensive than the marginal cost of adding records for additional SKUs. This marginal cost of record design for additional SKUs could be negligible or it could come close to doubling the costs; we therefore pick 1.5, the midpoint of 1 and 2, to be the cost multiplier.
Consistent with the analysis conducted for the Bioterrorism Act proposed recordkeeping rule, this record design cost is assumed to be shared between two facilities—the upstream facility and the downstream facility—as both will need to be involved in record production that meets the needs of both the supplier and customer for the cattle-derived ingredient.
Unlike the Bioterrorism Act proposed recordkeeping rule, we do not have direct information on all the facilities covered; we do not have data on the number of slaughter plants or renderers that supply cattle material for the food and cosmetic manufacturers and processors under FDA jurisdiction. FDA does, however, have some information on the number and type of downstream facilities that receive this material. Using information on the number of food and cosmetic manufacturers that may use cattle-derived ingredients subject to the interim final rule and this proposed rule, we can account for the total shared records costs by assuming that each food manufacturer or processor facility listed in table 1 of this document procures ingredients from one upstream slaughter plant or renderer. It is likely that each manufacturer or processor has a contractual relationship with an upstream slaughterer or renderer. FDA requests comment on whether food manufacturers and processors maintain contractual relationships with one or several cattle-material input suppliers. Information on food producing facilities in table 1 represents U.S. facilities; dietary supplement numbers account for both domestic and foreign facilities; cosmetics numbers account for both domestic and foreign input suppliers.
The recurring recordkeeping cost is the cost of ensuring that appropriate records document the absence of prohibited cattle materials in human food and cosmetics. The framework for estimating the amount of time required for FDA-regulated facilities to ensure adequate records for each shipment of materials is based on the regulatory impact analysis of the Bioterrorism Act proposed recordkeeping rule. In that analysis we estimated that 30 minutes per week would be required to ensure that records on each shipment to and from a facility contain adequate information regarding the contents of the package, the transporter, supplier, and receiver.
The recordkeeping requirements of this proposed rule would cover only a small fraction of all ingredients used in the food and cosmetic manufacturing processes and only require that records of cattle-derived ingredient origin from the input supplier be verified and maintained by the food or cosmetic manufacturer and processor. Because this recordkeeping requirement is less complex than the recordkeeping requirements under the Bioterrorism Act and affects fewer ingredients, we estimate the per facility burden to be about one-half of the burden estimated for the Bioterrorism Act proposed recordkeeping rule: 15 minutes per week, or 13 hours per year. FDA assumes that this recordkeeping burden would be shared between two entities (i.e., the slaughter plant and the manufacturer of finished products containing cattle-derived ingredients).
Table 2 of this document shows the recurring recordkeeping costs for food and cosmetics manufacturers that would be needed to comply with this proposed rule. As stated earlier, information on food producing facilities in table 2 represents U.S. facilities; dietary supplement numbers account for both domestic and foreign facilities; cosmetics numbers account for both domestic and foreign input suppliers.
c.
If we define the baseline risk as the expected annual number of cases of variant Creutzfeldt-Jakob disease (vCJD) per year, then the annual benefits of prohibiting prohibited cattle materials for use in foods and cosmetics would be:
(baseline annual cases of vCJD—annual cases of vCJD under FDA interim final rule) x (value of preventing a case of VCJD).
An alternative way to characterize benefits is:
Reduction in annual cases in vCJD under FDA interim final rule x (value of preventing a case of vCJD).
We do not know the baseline expected annual number of cases. But based on the epidemiology of vCJD in the United Kingdom, we anticipate much less than one case of vCJD per year in the United States. Because the interim final rule and this proposed rule would reduce rather than eliminate risk of exposure to BSE infectious materials, the reduction in the number of cases will be some fraction of the expected number. The value of preventing a case of vCJD is the value of a statistical life plus the value of preventing a year-long or longer illness that precedes certain death for victims of vCJD. In a recent rule making regarding labeling of trans fatty acids (68 FR 41434, July 11, 2003), we used a range of $5 million to $6.5 million for the value of a statistical life. The value of preventing a vCJD case would be even higher because of the significant medical costs associated with the illness (Ref. 8). We estimate that the value of preventing a single case of vCJD ranges from $5.7 million to $7.1 million. This estimate includes direct medical costs, reduced ability of the ill person to function at home and at work, and the cost of premature death.
As discussed in the companion interim final rule, the Harvard-Tuskegee study has stated that a ban on specified risk materials, including cattle brains, spinal cord and vertebral column, from
d.
FDA has examined the economic implications of this proposed rule as required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a rule has a significant economic impact on a substantial number of small entities, the Regulatory Flexibility Act requires agencies to analyze regulatory options that would lessen the economic effect of the rule on small entities. FDA finds that this proposed rule would have a significant economic impact on a substantial number of small entities.
First year costs of this proposed rule are about $1,800 per facility pair, with this cost divided between the upstream facility (slaughterhouse or rendering plant) and downstream facilities (manufacturers of food or cosmetics). FDA cannot determine if the cost sharing between the two firms would be equal. If the cost sharing is equal, then each facility would have to bear about a $900 first year cost to comply with the recordkeeping required by the proposed rule; if the cost sharing is not equal, then one facility in the partnership may bear zero costs all the way up to the total first year costs of $1,800. Recurring costs of this proposed rule are about $326 per facility relationship, which may be borne by only one firm or may be shared between facilities.
Using FDA's Small Business Model, we can estimate the number of facilities, when recordkeeping costs are shared and when they are not shared, that may go out of business as a result of this proposed rule.
Table 3 of this document shows that if facilities are only responsible for one-half of the recordkeeping cost burden (the burden is equally shared between the upstream and downstream facilities), then only two very small facilities (less than 20 employees) may be overburdened by having to comply with this proposed rule in a year's time; if the recordkeeping cost burden is borne by only one facility in the business relationship (either the upstream or the downstream firm), then six very small facilities (less than 20 employees) may have trouble complying with this interim final rule and staying in business. Facilities with 20 to 499 employees and facilities with at least 500 employees that must comply with this proposed rule are not in danger of having to stop operating as a result of the proposed rule.
Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1501
The Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121) defines a major rule for the purpose of congressional review as having caused or being likely to cause one or more of the following: An annual effect on the economy of $100 million or more; a major increase in costs or prices; significant adverse effects on competition, employment, productivity, or innovation; or significant adverse effects on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic or export markets. In accordance with the Small Business Regulatory Enforcement Fairness Act, OMB has determined that this proposed rule, should it become final, would not be a major rule for the purpose of congressional review.
This proposed rule contains information collections that are subject to review by OMB under the Paperwork Reduction act of 1995 (44 U.S.C. 3501-3520). A description of these provisions is given below with an estimate of the annual recorkeeping burden included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.
FDA invites comments on the following topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
FDA estimates the burden for this information collection as follows:
Burden:
FDA has determined that there are 575 facility relationships, consisting of the following facilities: A producer of cattle materials requiring records—this may be a slaughterhouse or renderer (the upstream facility) and a purchaser of cattle materials requiring documentation—this may be a human food or cosmetic manufacturer or processor. Together, the upstream and downstream facilities are responsible for designing records, verifying records, and storing records that contain information on sources of cattle materials.
In this hour burden estimate, as in the economic analysis, we treat these recordkeeping activities as shared activities between the upstream and downstream facilities. It is in the best interests of both facilities in the relationship to carry the burden necessary to comply with this proposed rule; therefore we estimate the time burden of developing these records as a joint task between the two facilities.
The first year burden of the proposed recordkeeping requirement consists of the facilities training their employees on how to keep the records necessary to comply with this proposed rule and designing the records. The one-time training burden incurred for each facility is assumed to be the equivalent of 1 month's worth of on-the-job training or approximately one-third of an hour. This time includes both the training required for personnel to verify that appropriate records have been received and/or created, and also the training required by personnel to file and maintain those records. Therefore, the total one-time training burden is 575 x 0.33 hrs = 190 hours.
We use the FDA Labeling Cost Model to estimate the one-time records design costs per facility of $1,785. This cost includes the costs of designing records for multiple products and consists $1,095 in labor costs (and $690 in capital costs which we deal with in the next section). Dividing the $1,095 of labor costs by the hourly wage for workers of $25.10 (doubled to include overhead), we have a design-time burden per facility of about 44 hours; we multiplied the burden per facility by 575 facilities to get an estimated total training and design burden of 25,490 hours.
Table 4 row 1 of this document shows the total hour burden from training and records design to be 44.33 hours per facility x 575 record keepers = 25,490 hours for the year.
The recurring recordkeeping burden is the burden of sending and verifying documents regarding shipments of cattle material that is to be used in human food and cosmetics.
We estimate this recurring recordkeeping burden will be about 15 minutes per week, or 13 hours per year. FDA assumes that this recordkeeping burden will be shared between two entities (i.e., the slaughter plant and the manufacturer of finished products containing cattle-derived ingredients). Therefore the total recurring burden will be 13 hrs x 575 = 7,475 hours, as shown in row 2 of table 4 of this document.
We use the FDA Labeling Cost Model to estimate the one-time records design costs per facility of $1,875 per facility, based on the facility producing multiple products with ingredients that now require records. Over $1,000 of the record design cost is due to labor, but $690 of the records design represents capital costs to each facility. The total capital costs for records design for all facilities is $690 x 575 = $396,750. These one time costs are shown in row 1 of table 4 of this document.
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)), the agency has submitted the information collection provisions of this proposed rule to OMB for review. Interested persons are requested to fax comments regarding information collection to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officer, FDA, FAX: 202-395-6974.
The agency has determined under 21 CFR 25.30(h) that this action is a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. We have determined that the proposed rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we have tentatively concluded that the proposed rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.
1. Model for Estimating the Impacts for Regulatory Costs on the Survival of Small Businesses and its Application to Four FDA-Regulated Industries, Final Report, Eastern Research Group, July 2002.
2. CTFA International Buyer's Guide, produced by the Cosmetics, Toiletries, and Fragrances Association (CTFA) found on the Internet at
3. Memorandum of Telephone Conversation, Dr. Gerald McEwen, Cosmetic, Toiletry, and Fragrance Association and Karen L. Carson, Food and Drug Administration, June 29, 2004.
4. United States International Trade Commission Interactive Tariff and Trade DataWeb, Essential Oils and Resinoids; Perfumery, Cosmetic or Toilet Preparations. Accessed online at
5. U.S. Census Bureau, 1997 Economic Census: Bridge Between NAICS and SIC Manufacturing. Accessed online at
6. FDA Dietary Supplement Products with Animal Ingredients Database (DSPD-A), September 2002, RTI International, contractor—FDA Contract Number 06673.013
7. FDA Labeling Cost Model, Final Report, Muth, M. K., E. C. Gledhill, and S. A. Karns, RTI, Health, Social, and Economics Research, Research Triangle, NC, April 2002.
8. Memorandum to the Record, The Costs of a Case of Variant Creutzfeldt-Jakob disease (vCJD), 2004.
Food additives, Food packaging, Substances prohibited from use in human food.
Cosmetics, Packaging and containers.
Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, the Food and Drug Administration proposes to amend 21 CFR parts 189 and 700 as follows:
1. The authority citation for 21 CFR part 189 is revised to read as follows:
21 U.S.C. 321, 342, 348, 371, 381.
2. Section 189.5 is amended by revising paragraph (c) to read as follows:
(c)(1) Records. Manufacturers and processors of human food that is manufactured from, processed with, or otherwise contains, material from cattle
(2) Records must be retained for 2 years after the date the records were created.
(3) Records must be retained at the manufacturing or processing establishment or at a reasonably accessible location.
(4) The maintenance of electronic records is acceptable. Electronic records are considered to be reasonably accessible if they are accessible from an onsite location.
(5) Records required by this subpart must be available to FDA for inspection and copying.
(6) Importers must electronically affirm their compliance with the recordkeeping requirements in paragraph (c)(1) of this section at the time of entry into the United States of human food manufactured from, processed with, or otherwise containing, material from cattle and must, if requested, provide the required records within a reasonable time.
(7) Records established or maintained to satisfy the requirements of this subpart that meet the definition of electronic records in § 11.3(b)(6) of this chapter are exempt from the requirements of part 11 of this chapter. Records that satisfy the requirements of this subpart but that are also required under other applicable statutory provisions or regulations remain subject to part 11 of this chapter.
3. The authority citation for 21 CFR part 700 continues to read as follows:
21 U. S. C. 321, 331, 352, 355, 361, 362, 371, 374.
4. Section 700.27 is amended by revising paragraph (c) to read as follows:
(c)(1) Records. Manufacturers and processors of a cosmetic that is manufactured from, processed with, or otherwise contains, material from cattle must establish and maintain records sufficient to demonstrate that the cosmetic is not manufactured from, processed with, or does not otherwise contain, prohibited cattle materials.
(2) Records must be retained for 2 years after the date the records were created.
(3) Records must be retained at the manufacturing or processing establishment or at a reasonably accessible location.
(4) The maintenance of electronic records is acceptable. Electronic records are considered to be reasonably accessible if they are accessible from an onsite location.
(5) Records required by this subpart must be available to FDA for inspection and copying.
(6) Importers must electronically affirm their compliance with the recordkeeping requirements in paragraph (c)(1) of this section at the time of entry into the United States of cosmetics manufactured from, processed with, or otherwise containing, material from cattle and must, if requested, provide the required records within a reasonable time.
(7) Records established or maintained to satisfy the requirements of this subpart that meet the definition of electronic records in § 11.3(b)(6) of this chapter are exempt from the requirements of part 11 of this chapter. Records that satisfy the requirements of this subpart but that are also required under other applicable statutory provisions or regulations remain subject to part 11 of this chapter.
Animal and Plant Health Inspection Service and Food Safety and Inspection Service, USDA; and Food and Drug Administration, HHS.
Advance notice of proposed rulemaking; invitation to comment.
Following detection of bovine spongiform encephalopathy (BSE) in an imported dairy cow in Washington State in December 2003, the Secretaries of the U.S. Departments of Agriculture and Health and Human Services announced a series of regulatory actions and policy changes to strengthen protections against the spread of BSE in U.S. cattle and against human exposure to the BSE agent. The Secretary of Agriculture also convened an international panel of experts on BSE to review the U.S. response to the Washington case and make recommendations that could provide meaningful additional public or animal health benefits. The purpose of this advance notice of proposed rulemaking is to inform the public about the panel's recommendations and to solicit comment on additional measures under consideration based on those recommendations and other considerations.
APHIS and FSIS will consider all comments received on or before September 13, 2004. FDA will consider all comments received on or before August 13, 2004.
• Postal Mail/Commercial Delivery: Please send four copies of your comment (an original and three copies) to Docket No. 04-047-1, Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. 04-047-1.
• E-mail: Address your comment to
• Agency Web Site: Go to
• Federal eRulemaking Portal: Go to
• Mail, including floppy disks or CD-ROM's, and hand-or courier-delivered items: Send to Docket Clerk, U.S. Department of Agriculture, Food Safety and Inspection Service, 300 12th Street, SW., Room 102 Cotton Annex, Washington, DC 20250.
• Federal eRulemaking Portal: Go to
• Federal eRulemaking Portal:
• Agency web site:
• E-mail:
• Fax: (301) 827-6870.
• Mail/hand delivery/courier (for paper, disc, or CD-ROM submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Bovine spongiform encephalopathy (BSE), widely referred to as “mad cow disease,” is a progressive and fatal neurological disorder of cattle. The disease was first diagnosed in 1986 in the United Kingdom, but had never been detected in a native animal in North America until May 2003 when it was diagnosed in a single dairy cow in Canada. Subsequently, in December 2003, BSE was diagnosed in a single dairy cow in Washington State that had been imported from Canada. Variant Creutzfeld-Jakob disease, a chronic and fatal neurodegenerative disease that affects humans, has been linked to the consumption of beef products contaminated with the BSE agent. The U.S. Government—specifically, the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA)—has implemented a number of measures to protect the public from health risks associated with BSE and to prevent the spread of the disease in U.S. cattle. The agencies are currently considering additional safeguards based on the recommendations of an international review team convened by the Secretary of Agriculture and on other considerations. The purpose of this advance notice of proposed rulemaking (ANPRM) is to inform the public about the report and recommendations of the international review team and to solicit public comment on the additional measures under consideration.
BSE belongs to the family of diseases known as transmissible spongiform encephalopathies (TSEs). In addition to BSE, TSEs include, among other diseases, scrapie in sheep and goats, chronic wasting disease (CWD) in deer and elk, and Creutzfeldt-Jakob disease (CJD) in humans. The agent that causes BSE and other TSEs has yet to be fully characterized. The theory that is most accepted in the scientific community is that the agent is a prion, which is an abnormal form of a normal protein known as cellular prion protein, although other agents have also been implicated. There is currently no test to detect the disease in a live animal. BSE is confirmed by postmortem microscopic examination of an animal's brain tissue or by detection of the abnormal form of the prion protein in an animal's tissues. The pathogenic form of the protein is both less soluble and more resistant to degradation than the normal form. The BSE agent is extremely resistant to heat and to normal sterilization processes. It does not evoke any demonstrated immune response or inflammatory reaction in host animals.
Since November 1986, there have been more than 180,000 confirmed cases of BSE in cattle worldwide. The disease has been confirmed in native-born cattle in 22 European countries in addition to the United Kingdom, and in some non-European countries, including Japan, Israel, and Canada. Over 95 percent of all BSE cases have occurred in the United Kingdom, where the epidemic peaked in 1992/1993, with approximately 1,000 new cases in cattle reported per week. Agricultural officials in the United Kingdom have taken a series of actions to eliminate BSE, including making it a reportable disease, banning mammalian meat-and-bone meal in feed for all food-producing animals, prohibiting the inclusion of animals more than 30 months of age in the animal and human food chains, and destroying all animals showing signs of BSE and other potentially exposed animals at high risk of developing the disease. As a result of these actions, most notably the feed bans, the rate of newly reported cases of BSE in the United Kingdom has decreased sharply and continues a downward trend.
In 1996, a newly recognized form of the human disease CJD, referred to as variant CJD (vCJD), was reported in the United Kingdom. Scientific and epidemiological studies have linked vCJD to exposure to the BSE agent, most likely through human consumption of cattle products contaminated with the agent that causes BSE. To date, approximately 150 probable and confirmed cases of vCJD have been reported in the United Kingdom, where there had been a high level of consumption of contaminated cattle product. In the United States, where measures to prevent the introduction and spread of BSE have been in place for some time, there is far less potential for human exposure to the BSE agent. The Centers for Disease Control and Prevention (CDC) leads a surveillance system for vCJD in the United States, and as of December 2003, had not detected vCJD in any resident of the United States that had not lived in or traveled to the United Kingdom for extended periods of time. In 2002, a probable case of vCJD was reported in a Florida resident who had lived in the United Kingdom during the BSE epidemic. Epidemiological data indicate that the patient likely was exposed to the BSE agent before moving to the United States.
The United States Government has implemented a number of measures since 1989 to prevent BSE from entering the United States and to prevent the spread of the disease should it be introduced into the United States.
Since 1989, USDA's Animal and Plant Health Inspection Service (APHIS) has prohibited the importation of live cattle and other ruminants and certain ruminant products, including most rendered protein products, into the United States from countries where BSE is known to exist. In 1997, due to concerns about widespread risk factors and inadequate surveillance for BSE in many European countries, APHIS extended importation restrictions on ruminants and ruminant products to all of the countries in Europe.
Also in 1997, HHS' Food and Drug Administration (FDA) prohibited the use of all mammalian protein, with the exception of pure pork and pure equine protein from single species processing plants, in animal feeds given to cattle and other ruminants (62 FR 30936; June 5, 1997; codified at 21 CFR 589.2000). The rule allows exceptions for certain products believed at the time to present a low risk of transmitting BSE: blood and blood products; gelatin; inspected meat products that have been cooked and offered for human food and further heat processed for feed (such as plate waste and used cellulosic food casings, referred to below as “plate waste”); and milk products (milk and milk protein). Firms must keep specified records on the manufacture of feed, have processes in place to prevent commingling of ruminant and nonruminant feed containing prohibited materials, and ensure that nonruminant feed containing materials prohibited in ruminant feed is labeled conspicuously with the statement, “Do not feed to cattle or other ruminants.”
In December 2000, APHIS expanded its prohibitions on imports of rendered ruminant protein products from BSE-restricted regions to include rendered protein products of any animal species because of concern that cattle feed supposedly free of ruminant protein may have been cross contaminated with the BSE agent. FDA also issued import alerts on animal feed ingredients for APHIS-listed countries.
The United States has had an active surveillance program for BSE since 1990. Historically, the sampling strategy was designed to detect one BSE-infected animal per million cattle and to take into account regional differences while striving for uniform surveillance throughout the country. Since 1993, BSE surveillance in the United States has met or exceeded international standards as outlined in the
Since its inception, animal surveillance for BSE in the United States has been designed to sample those cattle in which BSE is most likely to occur and in which the disease would most likely be detected. The targeted surveillance population has, therefore, included adult cattle displaying clinical signs that could be considered to be consistent with BSE. This includes cattle exhibiting signs of central nervous system (CNS) abnormalities, cattle that are non-ambulatory, cattle that have died on the farm from unexplained causes, and cattle that display other clinical signs that could be compatible with BSE. The BSE surveillance program has historically not included apparently healthy cattle presented for routine slaughter because that is not the population where the disease would most likely be detected.
Further, APHIS, in cooperation with USDA's Food Safety and Inspection Service (FSIS), prepared an emergency response plan to be used in the event that BSE is identified in the United States (
In April 1998, USDA contracted with the Harvard Center for Risk Analysis (HCRA) at Harvard University and the Center for Computational Epidemiology at Tuskegee University to conduct a comprehensive investigation of BSE risk in the United States. The report,
The Harvard-Tuskegee Study reviewed available scientific information related to BSE and other TSEs, assessed pathways by which BSE could potentially occur in the United States, and identified measures that could be taken to protect human and animal health in the United States. The assessment concluded that the United States is highly resistant to any proliferation of BSE or similar disease and that measures taken by the U.S. Government and industry make the United States robust against the spread of BSE to animals or humans should it be introduced into this country.
The Harvard-Tuskegee Study concluded that the most effective measures for reducing potential introduction and spread of BSE are: (1) The ban placed by APHIS on the importation of live ruminants and ruminant meat-and-bone meal from the United Kingdom since 1989 and all of Europe since 1997; and (2) the feed ban instituted in 1997 by FDA to prevent recycling of potentially infectious cattle tissue. The Harvard-Tuskegee Study further indicated that, if introduction of BSE had occurred via importation of live animals from the United Kingdom prior to 1989, mitigation measures already in place would have minimized exposure and begun to eliminate the disease from the cattle population.
The Harvard-Tuskegee Study also identified three pathways or practices that could facilitate human exposure to the BSE agent or the spread of BSE should it be introduced into the United States: (1) Non-compliance with FDA's ruminant feed regulations prohibiting the use of certain proteins in feed for cattle and other ruminants; (2) rendering of animals that die on the farm and use (through illegal diversion or cross contamination) of the rendered product in ruminant feed; and (3) the inclusion of high-risk tissues from cattle, such as brain and spinal cord, in products for human consumption. The Harvard-Tuskegee Study's independent evaluation of the potential risk mitigation measures predicts that a prohibition against rendering of animals that die on the farm would reduce the potential cases of BSE in cattle following hypothetical exposure by 82 percent as compared to the base case scenario,
Harvard Center for Risk Analysis, Harvard School of Public Health, and Center for Computational Epidemiology, College of Veterinary Medicine, Tuskegee University, “Evaluation of the Potential for Bovine Spongiform Encephalopathy in the United States,”
In 2003, following the identification of BSE in a native-born cow in Canada, the HCRA evaluated the implications of a then hypothetical introduction of BSE into the United States
In May 2004, USDA contracted with the HCRA to revise and update the BSE risk assessment model to reflect recent events that have occurred in the United States. These recent events include such increased risk mitigation measures as the prohibition of SRMs in human food.
On December 23, 2003, USDA announced a presumptive positive case of BSE in a dairy cow in Washington State. Samples had been taken from the cow on December 9 as part of USDA's BSE surveillance program. The BSE diagnosis was made on December 22 and 23 by histopathology and immunohistochemical testing at the National Veterinary Services Laboratories in Ames, IA, and verified on December 25 by the international reference laboratory, the Veterinary Laboratories Agency in Weybridge, England. This case followed the identification of BSE in a single cow in Alberta, Canada, in May 2003.
Upon detection of the BSE-positive cow in Washington State, USDA, FDA and other Federal and State agencies immediately began working together closely to perform a full epidemiological investigation
The epidemiological investigation and DNA test results confirm that the infected cow was not indigenous to the United States, but rather was born and most likely became infected in Alberta, Canada, prior to Canada's 1997 implementation of a ban on feeding mammalian protein to ruminants.
The infected cow entered the United States on September 4, 2001, as part of a shipment of 81 animals from the source herd in Canada. Of these 81 animals, 25 were determined, as a result of the epidemiological investigation, to be higher risk as defined by the OIE. A higher risk animal is one born on premises known to be a source of an infected animal within 12 months before or after the birth of the infected cow.
Counting the infected cow, USDA definitively accounted for 14 of the 25 animals considered to be higher risk, along with 15 others from the source herd that were in the initial shipment, plus 7 additional animals dispersed from the birth herd. The number of animals found—35 in addition to the infected cow—is consistent with the number expected after analysis of regional culling rates.
In addition to those animals, another 220 cattle were culled from 10 premises on which one or more source herd animals were found. These cattle were culled because they could possibly have been from the Canadian source herd. Out of an abundance of caution, all 255 animals were euthanized and tested for BSE; all of the animals tested negative. Because there is a small probability that BSE can be transmitted maternally, the two live offspring of the infected cow were also euthanized. A third had died at birth in October 2001. All carcasses were properly disposed of in accordance with Federal, State, and local regulations.
In conjunction with USDA's investigation, FDA conducted an extensive feed investigation. By December 27, 2003, FDA had located all potentially infectious product rendered from the BSE-positive cow in Washington State. The product was disposed of in a landfill in accordance with Federal, State, and local regulations.
The United States concluded the active investigation and culling activities related to the one infected cow on February 9, 2004, and redirected resources toward planning, implementing, and enforcing national policy measures to promote BSE surveillance and protect human and animal health.
Prior to the conclusion of the epidemiological investigation, on January 22-24, 2004, the Secretary of Agriculture convened an international panel of experts to assess the epidemiological investigation, provide expert opinion as to when the active phase should be terminated, consider the response actions of the United States to date, and provide recommendations as to actions that could be taken to provide additional meaningful human or animal health benefits in light of the North American experience.
The international review team was organized as a subcommittee of the Secretary of Agriculture's Foreign Animal and Poultry Disease Advisory Committee. The subcommittee consisted of Prof. U. Kihm (Switzerland), Prof. W. Hueston (USA), Dr. D. Matthews (UK), Prof. S. C. MacDiarmid (New Zealand), and Dr. D. Heim (Switzerland). The subcommittee (referred to below as the IRT) provided its report on February 4, 2004. The complete report, “
In summary, the IRT was complimentary of the scope, thoroughness, and appropriateness of the epidemiological investigation and concluded that the investigation conformed to international standards. The review team members concurred that the investigation should be terminated. In addition, the IRT made several policy recommendations designed to further reduce the risk of cattle being exposed to BSE. These recommendations included several changes that the Federal Government had already embarked upon related to SRMs, non-ambulatory (downer) cows, surveillance, laboratory diagnosis, feed restrictions, traceability (
APHIS, FSIS, and FDA have taken additional steps to specifically address the potential pathways or practices that the Harvard-Tuskegee Study said could contribute most either to the spread of BSE in cattle or to human exposure to the BSE agent should BSE be introduced into the United States.
FSIS, in a series of three interim final rules that were published and made effective on January 12, 2004, took additional measures to prevent the BSE agent from entering the human food supply. In its interim final rule titled,
To facilitate the enforcement of the SRM rule, FSIS has developed procedures to verify the approximate age of cattle that are slaughtered in official establishments. Such procedures, based on records or examination of teeth, are intended to ensure that SRM from cattle 30 months of age and older are effectively segregated from edible materials.
As provided by the SRM rule, materials designated as SRMs if they are from cattle 30 months of age and older will be deemed to be SRMs unless the establishment can demonstrate that they are from an animal that was younger than 30 months of age at the time of slaughter.
Furthermore, FSIS has developed procedures to verify that cross contamination of edible tissue with SRMs is reduced to the maximum extent practical in facilities that slaughter cattle, or process carcasses or parts of carcasses of cattle, both younger than 30 months of age and 30 months of age and older.
The SRM rule also declared mechanically separated beef (MS(beef)) to be inedible and prohibited its use for human food. Additionally, the SRM rule prohibited all non-ambulatory disabled cattle for use as human food.
The second interim final rule, titled, “Meat Produced by Advanced Meat/Bone Separation Machinery and Meat Recovery (AMR) Systems' (FSIS Docket No. 03-038IF; 69 FR 1874-1885), prohibited products produced by advanced meat recovery (AMR) systems from being labeled as “meat” if, among other things, they contain CNS tissue. AMR is a technology that removes muscle tissue from the bone of beef carcasses under high pressure without incorporating significant amounts of bone and bone products into the final meat product. FSIS had previously established and enforced regulations that prohibited spinal cord from being included in products labeled “meat.” This interim final rule expanded that prohibition to include dorsal root ganglia (DRG), clusters of cells connected to the spinal cord along the vertebral column. In addition, because the vertebral column and skull of cattle 30 months of age and older have been designated as SRM, they cannot be used for AMR. Because they are not SRMs, the skull and vertebral column from cattle younger than 30 months of age may be used in AMR systems. However, establishments that use skulls and vertebral columns in the production of beef AMR product must be able to demonstrate that such materials are from cattle younger than 30 months of age.
The third interim final rule, titled “Prohibition on the Use of Certain Stunning Devices Used to Immobilize Cattle During Slaughter” (FSIS Docket No. 01-0331IF; 69 FR 1885-1891), prohibited the use of penetrative captive bolt stunning devices that deliberately inject air into the cranial cavity of cattle because they may force large fragments of CNS tissue into the circulatory system of stunned cattle where they may become lodged in edible tissues.
Also on January 12, 2004, FSIS published a notice announcing that it would no longer pass and apply the mark of inspection to carcasses and parts of cattle selected for BSE testing by APHIS until the sample is determined to be negative (FSIS Docket No. 03-048N; 69 FR 1892; “Bovine Spongiform Encephalopathy Surveillance Program”).
FDA continues to conduct inspections to monitor compliance of feed mills, renderers, and protein blenders with the 1997 feed ban rule and is expanding the scope of its inspections to include other segments of animal feed production and use, such as transportation firms, farms that raise cattle, and animal feed salvage operations. Compliance by feed mills, renderers, and protein blenders with the feed ban is currently very high. Information on inspections and compliance is available at
FDA, like FSIS, has taken additional measures to prevent the BSE agent from entering the human food supply. In an interim final rule published in the Rules and Regulations section of today's
This interim final rule on human food and cosmetics, as well as a second one related to animal feed, were announced by FDA on January 26, 2004. The interim final rule on animal feed was to remove the current exemptions in 21 CFR 589.2000 for blood and blood products and plate waste, prohibit the use of poultry litter in ruminant feed, and require equipment, facilities, or production lines to be dedicated to nonruminant animal feed if firms use protein that is prohibited in ruminant feed.
The IRT recommendations provide a different set of measures for reducing the risks associated with animal feed. The IRT approach is to prevent potentially infective tissues from ever entering animal feed channels. Although FDA believes the measures previously announced would serve to reduce the already small risk of BSE
The Federal Government has also taken additional significant nonregulatory actions in response to the detection of BSE in North America. These actions include enhancing surveillance for BSE; implementing a national animal identification system; enhancing laboratory diagnosis; and obtaining and providing guidance and strategies for the future.
On March 15, 2004, Secretary of Agriculture Ann Veneman announced a one-time enhanced BSE surveillance plan, targeting cattle from populations considered at highest risk for BSE, as well as a sampling of animals from the clinically normal, aged cattle population (over 30 months as evidenced by the eruption of at least one of the second set of permanent incisors). The plan, implemented on June 1, 2004, incorporates recommendations from the IRT and the Harvard Center for Risk Analysis. Notably, the IRT has reviewed the surveillance plan and indicated that it is comprehensive and science-based, and that it addresses the important issues with regard to BSE surveillance in cattle.
Over a period of 12-18 months, APHIS will test as many cattle as possible in the targeted high-risk population. Data obtained in this effort will help determine the probable prevalence of BSE in the United States and whether risk management policies need to be adjusted. If at least 268,500 targeted high-risk animals are sampled, we will be able to detect BSE even if as few as 5 animals in this targeted population are positive. The key to surveillance is to look at the population of animals where the disease is likely to occur. Thus, if BSE is present in the U.S. cattle population, there is a significantly better chance of finding the BSE within this targeted high-risk cattle population than within the general cattle population.
In addition, FSIS public health veterinarians have begun assisting in APHIS’ BSE animal surveillance efforts by collecting brain samples from all cattle condemned during ante-mortem inspection at federally inspected establishments. This allows APHIS to focus on sample collection at locations other than federally inspected establishments, such as rendering operations and farms.
APHIS ensured access to slaughterhouses and rendering plants for sample collection via a final rule published March 4, 2004 (APHIS Docket No. 99-017-3, 69 FR 10137, “Blood and Tissue Collection at Slaughtering and Rendering Establishments”). Samples may also be collected on the farm, at veterinary diagnostic laboratories, at public health laboratories, at veterinary clinics, sale barns, livestock auctions, etc.
Strengthening of the passive surveillance system for BSE through outreach and education is an integral part of the USDA surveillance plan. In this regard, APHIS has developed plans to enhance existing educational materials and processes in conjunction with other Federal and State agencies. These outreach efforts will inform veterinarians, producers, and affiliated industries of the USDA surveillance goals and the sometimes subtle clinical signs of BSE, and will encourage reporting of suspect or targeted cattle on farm and elsewhere. One of the tools for reporting high-risk cattle, announced on June 8, 2004, is a toll-free number (1-866-536-7593).
To help cover additional costs incurred by industries participating in the surveillance plan, and to help encourage reporting and collection of targeted samples, USDA may provide payments for certain transportation, disposal, cold storage, and other costs.
For a complete discussion of the enhanced BSE surveillance plan that will be carried out over the next 12-18 months, refer to APHIS’ Bovine Spongiform Encephalopathy (BSE) Surveillance Plan of March 15, 2004 (available at
Testing of BSE surveillance samples is conducted at APHIS’ National Veterinary Services Laboratories (NVSL) and at a participating network of State and Federal veterinary diagnostic laboratories throughout the continental United States. USDA has approved 12 geographically dispersed laboratories to assist with BSE surveillance.
USDA has also approved five rapid screening test kits and has provided funding for high-throughput laboratory equipment as necessary. The rapid screening test kits are commercially produced diagnostic test kits, intended for use in surveillance programs such as these. These kits are best used as screening tests—
NVSL remains the national reference laboratory for BSE. If any sample reacts on the initial screening test, the tissues will be immediately forwarded to NVSL for confirmatory testing. Samples with this type of initial reaction will be reported as inconclusives. Samples will only be determined to be negative or positive by NVSL using immunohistochemistry and/or western blot confirmatory testing. NVSL will also conduct quality assurance check testing and test a certain number of routine samples to ensure proficiency in conducting all approved rapid screening tests.
USDA will make public the number of tests conducted and the results on a periodic basis. Updates are available at
The United States Government encourages and supports the development of new diagnostic tests for BSE and other TSEs. USDA researchers regularly discuss advancements in this area with their counterparts throughout the world and will evaluate all scientific data submitted as part of an application for USDA approval of a diagnostic test.
Animal disease outbreaks around the globe over the past decade and the detection of a BSE-positive cow in the United States in December 2003 have intensified public interest in developing a national animal identification program for the purpose of protecting animal health.
Having a system that can identify individual animals or groups, the premises where they are located, and the date of entry to each premises is fundamental to controlling any disease threat, foreign or domestic, to U.S. animal resources. Further, we must be able to retrieve this information in a timely manner after confirmation of disease outbreak in order to implement successful intervention strategies.
While there is currently no nationwide animal identification system in the United States for all animals of a given species, some segments of certain species are required to be identified as part of current APHIS disease eradication activities. In addition, some significant regional voluntary identification programs are in place, and others are currently being developed and tested.
USDA has defined several key objectives for a national system. These include: (1) Allowing producers, to the extent possible, the flexibility to use current systems or adopt new ones; (2) having a system that is technology neutral, so that all existing effective technologies and new technologies that may be developed in the future may be utilized; (3) having a system that builds upon national data standards to ensure that a uniform and compatible system evolves; (4) having a system that does not preclude producers from being able to use it with production management systems that respond to market incentives; and (5) designing the architecture so that the system does not unduly increase the role and size of the Government.
Design and implementation of such a national animal identification system are well under way (see
APHIS will initially fund cooperative agreements to help State and Tribal governments establish premises identification systems and to evaluate additional identification pilot projects that could also become a part of the overall animal identification system. Associations and other segments of the livestock industry may participate in State and Tribal projects. APHIS posted a request for proposals for these cooperative agreements in June and will accept applications until July 15, 2004. APHIS anticipates initiating projects funded through these cooperative agreements in August. USDA is currently conducting a series of listening sessions (June-August 2004) across the country, inviting public discussion on the national animal identification program.
The Federal Government has several existing mechanisms to ensure appropriate guidance and involvement from outside experts and interested stakeholders. The Secretary of Agriculture's Advisory Committee on Foreign Animal and Poultry Diseases (SACFAPD), which has 17 members from industry, States, and academia, advises the Secretary on program operations, measures to prevent the introduction of foreign animal diseases into the United States, and contingency measures should such a disease be introduced into the United States. This group meets regularly and can also solicit public and expert advice. In fact, the IRT was convened as a subcommittee of the SACFAPD. Similarly, FDA obtains guidance from outside experts through its Transmissible Spongiform Encephalopathy Advisory Committee (TSEAC). In addition, FDA's TSEAC includes a representative from APHIS.
The Federal Government also obtains guidance and advice from experts within the Government. USDA has an internal Transmissible Spongiform Encephalopathy (TSE) Working Group that provides scientific recommendations related to TSEs, including BSE. This technical group meets regularly and includes representatives from FSIS and USDA's Agricultural Research Service, as well as from HHS’ Centers for Disease Control and Prevention, the National Institutes of Health, and FDA, and the Department of Defense, as needed. There is also a policy level Interagency TSE Working Group that provides support and advice.
Furthermore, USDA and HHS participate on international working groups set up to prevent the spread of BSE to new areas of the world and to standardize approaches for addressing BSE surveillance and response. USDA and HHS participate in OIE meetings as members and consultants, and U.S. representatives offer technical advice on BSE-related issues and uphold U.S. interests in the World Health Organization and the Pan American Health Organization as well. Since 1986, the United States has exchanged scientists with several European countries, and U.S. officials have historically and routinely met with their counterparts in many countries on animal health risk mitigation measures. A standing North American Animal Health Committee that includes chief veterinary officers from Canada, Mexico, and the United States has developed and is working to implement a North American BSE strategy. After the finding of the BSE-positive cow in Canada in May 2003, U.S., Canadian, and Mexican officials sent a letter to the OIE regarding a scientific approach to BSE and trade issues. The United States has also taken a leadership role by proposing a new “minimal risk” BSE classification and criteria for trade in low-risk products for countries with established mitigation measures and a low incidence of BSE (APHIS Docket No. 03-080-1; 68 FR 62386-62405; November 4, 2003: “Bovine Spongiform Encephalopathy; Minimal Risk Regions and Importation of Commodities”).
As recognized in the Agreement on the Application of Sanitary and Phytosanitary Measures (“SPS Agreement”) under the auspices of the World Trade Organization (“WTO”), the OIE is the relevant international organization responsible for development and periodic review of standards, guidelines, and recommendations with respect to animal health and zoonoses (diseases that are transmissible from animals to humans). The OIE criteria for terrestrial animals (mammals, birds, and bees) are detailed in the
Chapter 2.3.13 of the
The current OIE standards contain criteria for establishing the BSE risk status of a country or zone. Under the current standards, the BSE-risk status of a country or zone is determined on the basis of a risk assessment identifying all potential factors for BSE occurrence and their historic perspective; an assessment of the likelihood that a TSE agent has been introduced via the importation of potentially contaminated animals or commodities (
To increase the likelihood of detecting BSE, the OIE recommends surveillance targeting cattle displaying clinical signs compatible with BSE and cattle that have died or been killed for reasons other than routine slaughter. In countries or zones not free of BSE, the OIE recommends routine sampling at slaughter. Surveillance should focus primarily on cattle over 30 months of age. The OIE also recommends a minimum number of samples to be taken from the targeted population for effective surveillance, based on the total cattle population over 30 months of age.
The OIE currently specifies five BSE status levels for countries or zones: Free, provisionally free, minimal risk, moderate risk, and high risk. The purpose of the categorization system is to enable and encourage appropriate risk mitigation measures to be applied to commodities for trade.
The OIE also sets international standards for trade in live cattle, fresh meat and meat products, gelatin and collagen prepared from bones, tallow and tallow derivatives, and dicalcium phosphate, according to the BSE risk status of a country or zone. In order to protect public and animal health, the OIE currently recommends different risk mitigating measures, with increased requirements as the status of a country or zone moves from lower to higher levels of BSE risk. The present OIE Code does not suggest a total embargo of animals and animal products coming from BSE affected countries, not even from countries considered as having high BSE risk, as long as the proper risk mitigation measures are applied.
The OIE also identifies certain commodities that should not require any BSE-related restrictions, regardless of the BSE status of the exporting country or zone. For example, the
The actions taken by the U.S. Government to prevent the introduction and spread of BSE in the United States are generally consistent with international standards for BSE, although not in all cases exactly the same. For example, U.S. surveillance for BSE in cattle has exceeded the OIE standards since 1993. Based on an adult cattle population of approximately 40 million, the OIE standard (Terrestrial Animal Health Code Appendix 3.8.4) calls for a minimum of 433 samples. By comparison, the United States has increased the number of samples from approximately 700 in fiscal year 1993 to approximately 20,000 in fiscal year 2002.
USDA appreciates the significant contributions of the OIE to science-based understanding of the true BSE-related risks in international trade and will continue to work with the OIE and other relevant international organizations. The United States is also taking a leadership role by proposing criteria for low-risk product trade with countries that have a low incidence of BSE and historically strong risk mitigation measures, mentioned previously in this document in section III,
In its general remarks about actions taken by the United States in response to the case of BSE in Washington State, the IRT, under “Response actions,” recommended that policy actions under consideration by the United States achieve the following objectives:
• Reduce public health risk for consumer protection.
• Limit recycling and amplification of the agent.
• Establish the level of effectiveness of measures through surveillance.
• Prevent any inadvertent introduction of BSE from abroad in the future.
• Contribute to the prevention of the spread of the epidemic worldwide [p. 3].
The IRT report further stated:
To achieve the above objectives, a system of complementary barriers, and implementation and enforcement of all measures on the national level, is necessary.
The objectives cannot be successfully achieved by government alone; effective implementation of measures requires a shared commitment and action on the part of national and state governments, producers, consumers, private industry, and veterinary professionals. Extensive national coordination and cooperation is imperative, and should be extended to include the continent of North America. We suggest that a BSE task force, which includes governmental and non governmental stakeholders, is established under the leadership of the USDA in order to assure that policies are developed and implemented in a consistent, scientifically valid manner. [p. 3]
As noted earlier in section III,
USDA welcomes comment on the following question:
1. Would there be value in establishing a specialized advisory committee or standing subcommittee on BSE?
The IRT also evaluated actions taken by the U.S. Government in response to the confirmation of the case of BSE in the United States and made recommendations regarding further actions that could provide additional public or animal health benefits. We are requesting public comment below on additional measures we are considering based on the IRT's recommendations. Because we believe that prior actions taken by the Federal Government already address IRT recommendations related to surveillance, laboratory diagnosis, non-ambulatory (downer) cattle, and certain other recommendations (
In the section of the IRT report headed, “Specified Risk Materials (SRM),” the IRT stated:
Unless aggressive surveillance proves the BSE risk in the USA to be minimal according to OIE standards, the [IRT] recommends that the SRM identified below be excluded from both the human and animal food chains.
• Brain and spinal cord of all cattle over 12 months of age.
• Skull and vertebral column of cattle over 12 months of age—these are not inherently infected, but cannot be separated from dorsal root/trigeminal ganglia or from residual contamination with CNS tissue.
• Intestine—from pylorus to anus—from all cattle.
In the mean time, until the level of BSE risk has been established, the [IRT] concedes that exclusion of CNS, skull, and vertebral column from cattle over 30 months, and intestines from cattle of all ages, for use in human food is a reasonable temporary compromise. [pp. 3-4]
USDA has initiated an aggressive and comprehensive surveillance program that will assist in estimating the prevalence of BSE in the United States and provide a basis for further assessments of whether and how U.S. actions related to BSE should be adjusted. Also, FSIS and FDA require the exclusion of CNS tissue, skull, and vertebral column from cattle 30 months of age and older, and the small intestine and tonsils from cattle of all ages, from human food, including dietary supplements, and cosmetics.
With regard to the age of cattle from which SRMs should be removed, FSIS and FDA have specified that CNS tissue, skull and vertebral column should be removed from cattle 30 months of age and older. Research to date indicates that 30 months is the appropriate threshold for removal of these materials unless surveillance indicates that there is a high prevalence of BSE in the U.S. cattle population, which the agencies believe is unlikely because of the feed and import restrictions that the Federal Government has imposed. The reason that age matters at all is that levels of infectious agent in certain tissues vary with the age of animal. Pathogenesis studies, where tissues obtained from orally infected calves were assayed for infectivity, have shown that infectivity was not detected in most tissues until at least 32 months post-exposure.
Wells, G.A.H.,
European Union Scientific Steering Committee (EU SSC), 2002. Update of the opinion on TSE infectivity distribution in ruminant tissues (initially adopted by the Scientific Steering Committee at its meeting of 10-11 January 2002 and amended at its meeting of 7-8 November 2002) following the submission of (1) a risk assessment by the German Federal Ministry of Consumer Protection, Food, and Agriculture and (2) new scientific evidence regarding BSE infectivity distribution in tonsils; European Commission, Scientific Steering Committee, Health and Consumer Protection Directorate General;
Although a few cases of BSE have been found in cattle under 30 months of age, research demonstrates that the shorter incubation period (
Department for Environment, Food and Rural Affairs (DEFRA), U.K., 2003; DEFRA BSE information,
BSE testing in the European Union (EU) was conducted throughout the year 2001. This testing revealed only two positive animals that were younger than 30 months of age in a total of 2,147 positive cases. Of note is that these animals were 28 and 29 months of age. For reference, in 2001, a total of 8,516,227 tests were conducted within the EU, and, of those, 1,366,243 tests were conducted on animals less than 30 months of age. In 2002, there were no animals less than 30 months of age that were positive in the EU testing scheme. Approximately 10.2 million tests were conducted in EU Member States in 2002, and, of these, 1.6 million were conducted on animals less than 30 months of age. The average mean age of positive animals in the EU in 2002 was 96.9 months, an increase from 85.9 months in 2001.
European Commission (EC), 2003; Report on the monitoring and testing of ruminants for the presence of transmissible spongiform encephalopathy (TSE) in 2002, European Commission Health and Consumer Protection Directorate-General;
This suggests an effective and prudent dividing line for purposes of mitigating risk. Infected cattle over 30 months of age may have levels of the abnormal prion in affected tissues that are sufficient to infect other animals fed protein derived from these tissues. Infected cattle younger than 30 months of age are unlikely to have infectious levels of the prion protein.
With respect to the IRT recommendation that the entire intestine from cattle of all ages should be excluded from the human and animal food chains, FSIS noted in its SRM rule that BSE infectivity has only been confirmed in the distal ileum of the small intestine. FSIS requires the entire small intestine to be removed and disposed of as inedible to ensure effective removal of the distal ileum. Consistent with USDA's restrictions, FDA prohibits the use of the small intestine in FDA-regulated human food and cosmetics.
The aspect of this recommendation pertaining to removal of SRMs from animal feed is addressed below under “Animal Feed Restrictions.”)
FSIS and FDA request comment, especially scientific information, on the following question:
2. What data or scientific information is available to evaluate the IRT recommendation described above, including that aspect of the recommendation concerning what portion of the intestine should be removed to prevent potentially infective material from entering the human food and animal feed chains?
In the “Feed Restrictions” section of the report, the IRT recommended: “All SRM should be excluded from all animal feed, including pet food.” [p. 5] FDA has prohibited the use of most mammalian proteins in ruminant feed since 1997. The IRT report stated that, “Considering the BSE situation in North America, the [IRT] believes the partial (ruminant to ruminant) feed ban that is currently in place is insufficient to prevent exposure of cattle to the BSE agent.” [p. 5] The IRT further stated that, “While science would support the feed bans limited to the prohibition of ruminant derived [meat and bone meal] MBM in ruminant feed, practical difficulties of enforcement demand more pragmatic and effective solutions.” [p. 6] Specifically, the IRT cited epidemiological evidence in the United Kingdom that highlight the dangers of cattle infection through the consumption of feed that had been contaminated accidentally when manufactured in premises that legitimately used mammalian meat and bone meal in feed for pigs and poultry. [p. 5] In addition, the IRT report cited an ongoing attack rate study at the Veterinary Laboratories Agency in the United Kingdom that demonstrates
To assist FDA in completing that proposal, FDA seeks comment on the following questions:
3. What information, especially scientific data, is available to support or refute the assertion that removing SRMs from all animal feed is necessary to effectively reduce the risks of cross-contamination of ruminant feed or of feeding errors on the farm? What information is available on the occurrence of on-farm feeding errors or cross-contamination of ruminant feed with prohibited material?
4. If SRMs are prohibited from animal feed, should the list of SRMs be the same list as for human food? What information is available to support having two different lists?
5. What methods are available for verifying that a feed or feed ingredient does not contain SRMs?
6. If SRMs are prohibited from animal feed, what requirements (labeling, marking, denaturing) should be implemented to prevent cross-contamination between SRM-free rendered material and material rendered from SRMs?
7. What would be the economic and environmental impacts of prohibiting SRMs from use in all animal feed?
8. What data are available on the extent of direct human exposure (contact, ingestion) to animal feed, including pet food? To the degree such exposure may occur, is it a relevant concern for supporting SRM removal from all animal feed?
The “Feed restrictions” section of the IRT report also stated:
Cross contamination must be prevented throughout the feed chain, from reception and transportation of feed ingredients, during the manufacturing process, through transportation and storage of finished feed, and on farm where mixing, blending, and feeding will occur. [p. 6]
The 1997 feed rule required manufacturers and distributors that handle both prohibited and nonprohibited material to control cross contamination by either: (1) Maintaining separate equipment or facilities; or (2) using clean-out procedures or other means adequate to prevent carry-over of prohibited material into feed for ruminant animals. In response to the finding of a BSE-positive cow in Washington State, FDA announced its intention to strengthen measures to prevent cross contamination by requiring dedicated equipment or facilities. However, in light of the IRT's recommendations, if SRMs are prohibited in all animal feed, dedicated facilities may no longer be necessary to reduce the risk associated with cross contamination. Therefore, FDA is reevaluating the need for requiring dedicated facilities.
FDA seeks comment on the following questions:
9. What information, especially scientific data, is available to show that dedicated facilities, equipment, storage, and transportation are necessary to ensure that cross contamination is prevented? If FDA were to prohibit SRMs from being used in animal feed, would there be a need to require dedicated facilities, equipment, storage, and transportation? If so, what would be the scientific basis for such a prohibition?
10. What would be the economic and environmental impacts of requiring dedicated facilities, equipment, storage, and transportation?
11. What information, especially scientific data, is available to demonstrate that clean-out would provide adequate protection against cross contamination if SRMs are excluded from all animal feed?
As reported in the “Feed restrictions” section of the IRT report:
The [IRT] recommends that the current feed ban be extended to exclude all mammalian and poultry protein from all ruminant feeds, and that this ban as well as measures to prevent cross contamination be strongly enforced. This recommendation must be enforced through an inspection program including sampling and testing of feed. [p. 6]
As noted previously, although the IRT agreed that “science would support the feed bans limited to the prohibition of ruminant derived MBM in ruminant feed,” the IRT stated that “practical difficulties of enforcement demand more pragmatic and effective solutions.” [p. 6] In particular, the IRT said:
The prohibition of the use of all MBM (including avian) in ruminant feed is justified partly due to the issues of cross contamination as well as the current problems in differentiating mammalian and avian MBM. It also prevents the inclusion of ruminant derived protein contained within the lumen of porcine or avian intestines at slaughter in animal feed that may be used for ruminants. [p. 6]
Although the IRT discussed the problems with rendered MBM, the IRT report did not specifically address the potential risks from other mammalian and avian protein, such as milk, blood, gelatin, and tallow (rendered fat) that may contain small amounts of protein. The 1997 final rule, which banned the use of most mammalian protein in ruminant feed, did not include these materials in the definition of animal proteins prohibited in ruminant feed because they were not considered to pose a risk of BSE transmission. Prior to release of the IRT recommendations, FDA had announced its intentions to eliminate exemptions in the current ruminant feed rule for blood and blood products and plate waste, and to prohibit the practice of incorporating poultry litter into ruminant feed. FDA is now evaluating whether the announced measures need to be modified in light of the IRT recommendations. With respect to tallow, the OIE categorizes tallow with a maximum level of insoluble impurities of 0.15 percent as protein-free tallow and recommends that tallow that meets this standard be freely traded regardless of the BSE status of the country of origin.
FDA seeks comment on the following questions:
12. What information, especially scientific data, supports banning all mammalian and avian MBM in ruminant feed?
13. If SRMs are required to be removed from all animal feed, what information, especially scientific data, is available to support the necessity to also prohibit all mammalian and avian MBM from ruminant feed, or to otherwise amend the existing ruminant feed rule?
14. What would be the economic and environmental impacts of prohibiting all mammalian and avian MBM from ruminant feed?
15. Is there scientific evidence to show that the use of bovine blood or blood products in feed poses a risk of BSE transmission in cattle and other ruminants?
16. What information is available to show that plate waste poses a risk of BSE transmission in cattle and other ruminants?
17. If FDA were to prohibit SRMs from being used in animal feed, would there be a need to prohibit the use of poultry litter in ruminant feed? If so, what would be the scientific basis for such a prohibition?
18. What would be the economic and environmental impacts of prohibiting bovine blood or blood products, plate waste, or poultry litter from ruminant feed?
19. Is there any information, especially scientific data, showing that tallow derived from the rendering of SRMs, dead stock, and non-ambulatory disabled cattle poses a significant risk of BSE transmission if the insoluble impurities level in the tallow is less than 0.15 percent?
In the “Non-ambulatory (downer) cows” section of the report, the IRT noted the need to prevent potentially infective tissues from entering the feed chain. [p. 4] In addition to downer cattle, FDA is concerned about cattle that die on the farm or are killed for humane reasons (
FDA seeks comment on the following questions:
20. Can SRMs be effectively removed from dead stock and non-ambulatory disabled cattle so that the remaining materials can be used in animal feed, or is it necessary to prohibit the entire carcass from dead stock and non-ambulatory disabled cattle from use in all animal feed?
21. What methods are available for verifying that a feed or feed ingredient does not contain materials from dead stock and non-ambulatory disabled cattle?
22. What would be the economic and environmental impacts of prohibiting materials from dead stock and non-ambulatory disabled cattle from use in all animal feed?
Additionally, in the “Feed restrictions” section of the report, the IRT stated:
Recognising the absence of an established infrastructure for the separation and disposal of SRM or MBM the subcommittee accepted that a staged approach may be necessary for implementation. Exclusion and destruction of such a high volume of raw material is a massive burden on all countries currently affected by BSE. Given the susceptibility of cattle to low dose exposure, and the fact that no processing system exists at present to guarantee destruction of infectivity in commercial processes, it is probable that restoration of traditional uses in feed may be impossible. More radical and innovative solutions are required to enable the safe use of such materials in future. This should include adding value through their use for purposes other than the manufacture of feed and fertilisers (
USDA's Rural Business-Cooperative Service announced on May 18, 2004, a pilot project to provide guaranteed loans to rural small businesses for developing renewable energy systems primarily through use of specified risk materials, non-ambulatory cattle, or other cattle deemed to be at risk of carrying BSE (69 FR 28111-29119). Applications must be received by August 16, 2004.
APHIS welcomes comment on the following question:
23. What other innovative solutions could be explored?
In the section of the IRT report headed, “Traceability,” the IRT acknowledged that the U.S. Government has “recognized the importance of effective identification and traceability systems, that have value not only for the cost-effective and rapid tracing of animals for culling, but also for containment of contagious diseases.” [p. 6] The IRT “encourages the implementation of a national identification system that is appropriate to North American farming.” [p. 6]
As discussed in section III,
The national animal identification system will allow the Federal Government to trace back and trace forward animals potentially exposed to a disease of concern. Traceback refers to the ability to track an animal's location over its lifespan and the ability to determine which animals may have been in contact with the diseased animal or shared a contaminated feed supply. Trace forward data provides locations of animals moved out of the premises of concern that may have been exposed to the disease. When fully implemented, the national animal identification system calls for a trace to be completed within 48 hours of detecting a disease, thereby helping to contain an outbreak. The ability to achieve the 48-hour goal is directly related to the completeness of animal movement data that is reported to the national system. Developing and establishing all components of this national system present significant challenges.
APHIS recognizes the need to be able to ensure that data provided by producers is protected, and that all components of the system are in place and have been tested, before making the system mandatory. APHIS also recognizes that market forces will affect producer involvement (
APHIS invites comment on the following questions:
24. When and under what circumstances should the program transition from voluntary to mandatory?
25. What species should be covered, both initially and in the longer term? Specifically, should the initial emphasis be on cattle, or also cover other species? If so which? Which species should be covered by the program when it is fully implemented? What priority should be given to including different species?
In the section of the IRT report headed, “Education,” the IRT stated:
BSE educational programs must be designed to meet the needs of multiple audiences with variable levels of scientific training. Countries around the world have routinely underestimated the need for a wide variety of educational materials and training techniques to meet both technical and non-technical audiences. The [IRT] recommends that extensive education and training materials be developed in collaboration with academic, professional, trade and consumer organizations so that scientifically sound and accurate information about the nature of BSE and the importance of aggressive prevention and control strategies can be disseminated widely and incorporated into the curricula of schools, college, universities and professional continuing education programs. As traceability, transparency and access to current information increases, so does consumer confidence and effectiveness of the control and prevention measures. [pp. 6-7]
FDA, FSIS, and APHIS continue to develop educational and training materials. BSE became a reportable
All three agencies welcome comment on the following questions:
26. How can training and educational materials be designed or improved to meet the needs of multiple audiences with variable levels of scientific training?
27. How can the Federal Government increase access to these materials?
FDA believes it is necessary to consider the current state of technology when developing new requirements for animal feeds. The IRT report cites the limitations of sampling techniques and test sensitivity as the rationale, in part, for why further restrictions are needed to prevent cross contamination. The IRT noted:
If at some point it becomes possible through other means (
FDA is interested in the impact of technology development on all possible new requirements and seeks comment on the following questions:
28. Should FDA include exemptions to any new requirements to take into account the future development of new technologies or test methods that would establish that feed does not present a risk of BSE to ruminants?
29. If so, what process should FDA use to determine that the technologies or test methods are practical for use by the feed industry and ruminant feeders and provide scientifically valid and reliable results?
FDA requests comments on the following questions:
30. Do FDA's existing authorities under the Federal Food, Drug, and Cosmetic Act (that address food adulteration and misbranding) and under the Public Health Service Act (that address the prevention and spread of communicable diseases) provide a legal basis to ban the use of SRMs and other cattle material in nonruminant animal feed (
31. Are there other, related legal issues on which FDA should focus?
As discussed in section III,
FSIS welcomes comment, especially scientific information, on the following questions:
32. What measures are necessary to prevent cross contamination between carcasses?
33. In establishments that predominantly slaughter cattle 30 months of age and older. are additional sanitation requirements necessary to prevent edible portions of carcasses from being contaminated with SRMs?
In response to the FSIS rule that prohibits SRMs and non-ambulatory disabled cattle for use in human food, FSIS has received several comments from countries that consider themselves “BSE free” requesting that the Agency exempt countries recognized as “BSE free” or “provisionally free” from the requirements of the interim final rule. According to these countries, their BSE status provides the same level of protection against BSE that is achieved domestically by the provisions in the FSIS interim final rule. Therefore, these countries assert that their BSE status is an “equivalent sanitary measure.”
Meat and meat products exported to the United States from another nation must meet all sanitary standards applied to meat and meat products produced in the United States. The United States makes determinations of equivalence by evaluating whether foreign food regulatory systems attain the appropriate level of protection provided by our domestic system. Thus, while foreign food regulatory systems need not be identical to the U.S. system, they must employ equivalent sanitary measures that provide the same level of protection against food safety hazards as achieved domestically.
Currently, the prohibition on the use of materials designated as SRMs in FSIS” SRM rule applies to all such materials, regardless of the BSE status of the country of origin, as does the prohibition on the slaughter of non-ambulatory disabled cattle. However, as discussed earlier in this document, the OIE standards for trade in bovine-derived products, including meat and meat products, take into consideration the BSE risk status of a country or zone.
Therefore, FSIS requests comments on the following questions:
34. Should FSIS provide an exemption for “BSE free” countries or countries with some other low-risk BSE designation?
35. If FSIS were to exempt “BSE free” countries from the provisions of the SRM rule, what standards should the Agency apply to determine a country's BSE status?
36. How would FSIS determine that country meets such standards? For example, should it rely on third party evaluations, such as the OIE, or conduct its own evaluation?
In the interim final rule on prohibited cattle material in human food and cosmetics published in the Rules and Regulations section of this
APHIS, FSIS, and FDA invite public comment on the issues and questions presented in this ANPRM. To facilitate each agency's review of comments, we ask that comments be submitted to the agency (APHIS, FSIS or FDA) that is seeking comment on the particular question the comment addresses. The agency or agencies that wish to receive comments on a particular issue are identified before each question or set of questions in sections V or VI. Comments should be submitted to all agencies only when comments address general questions or issues applicable to all agencies. Comment submissions should include the appropriate agency docket number(s). Please refer to the docket numbers and instructions for submitting comments in the
Please also note that the comment periods established by each agency are different. FDA intends to issue a proposed rule on animal feeds subsequent to publication of this ANPRM. To facilitate FDA's consideration of those comments in developing the proposed rule, please submit comments specific to the FDA issues and questions to FDA prior to close of the 30-day comment period listed for FDA in the
7 U.S.C. 8301-8317; 21 U.S.C. 321, 342, 343, 348, 371, and 601-695.
Securities and Exchange Commission.
Proposed rule.
The Securities and Exchange Commission (“Commission”) is publishing for comment proposed rules to implement the affiliate marketing provisions in Section 214 of the Fair and Accurate Credit Transactions Act of 2003, which amends the Fair Credit Reporting Act. Section 214 requires the Commission and other Federal agencies to adopt rules implementing limitations on a person's use of certain information received from an affiliate to solicit a consumer for marketing purposes, unless the consumer has been given notice and an opportunity to opt out of having the information used for those purposes.
Comments should be received on or before August 13, 2004.
Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an e-mail to
• Use the Federal eRulemaking Portal (
• Send paper comments in triplicate to Jonathan G. Katz, Secretary, Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC 20549-0609.
All submissions should refer to File Number S7-29-04. This file number should be included on the subject line if e-mail is used. To help us process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site (
For information regarding the proposed rules as they relate to brokers, dealers, or transfer agents contact Catherine McGuire, Chief Counsel, Brian Bussey, Assistant Chief Counsel, or Tara Prigge, Attorney, Office of Chief Counsel, at the Division of Market Regulation, (202) 942-0073, or regarding the proposed rules as they relate to investment companies or investment advisers, contact Penelope W. Saltzman, Branch Chief, or Hugh Lutz, Attorney, Office of Regulatory Policy, at the Division of Investment Management, (202) 942-0690, Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC 20549.
The Commission is proposing for public comment Regulation S-AM, 17 CFR 247.1 through 247.27, under Section 214 of the Fair and Accurate Credit Transactions Act of 2003 (“FACT Act”).
The FACT Act was signed into law on December 4, 2003.
A portion of Section 214 of the FACT Act amends the FCRA to add a new Section 624, while other provisions of Section 214 are not incorporated into the FCRA. Throughout this release, references to “Section 214 of the FACT Act” or “Section 624 of the FCRA” are used depending on the portion of Section 214 to which the reference relates.
Section 214 requires the Office of the Comptroller of the Currency, the Board of Governors of the Federal Reserve System, the Federal Deposit Insurance Corporation, the Office of Thrift Supervision (collectively, the “Banking Agencies”), the National Credit Union Administration, the Federal Trade Commission (collectively with the Banking Agencies, the “Agencies”), and the Commission, in consultation and coordination with one another, to issue implementing rules. These rules must be issued in final form not later than nine months after the date of enactment,
Commission staff worked with staff from the Agencies in developing proposed rules to implement Section 214. As required by Section 214, proposed Regulation S-AM is, to the extent possible, consistent with and comparable to the regulations proposed by the Agencies.
New Section 624 of the FCRA generally establishes conditions that must be met before a person may use certain information for marketing purposes if the information is obtained from an affiliate. Before a person may make marketing solicitations to a consumer using certain information about that consumer, the consumer must be given notice and a reasonable opportunity to opt out of having the information used for this purpose. Thus, Section 624 governs the use of certain information by an affiliate, and not the sharing of information with or among affiliates.
The FCRA also allows that a person may communicate to its affiliates information other than transaction or experience information without becoming a consumer reporting agency if the person first gives the consumer a clear and conspicuous notice that such information may be communicated to its affiliates and an opportunity to “opt out,” or block the person from sharing the information.
Section 624(a)(1) of the FCRA directs that a person that receives “eligibility information”
Arguments can be made for imposing this responsibility on either affiliate. Because Section 624 is drafted as a prohibition on the use of information by the receiving affiliate, and does not explicitly impose any affirmative duty on the communicating affiliate, the receiving affiliate could be required to take responsibility for giving the notice. However, the language in Section 624(a)(1)(A), which provides that the notice to the consumer must state that information “may be communicated” among affiliates for the purpose of making marketing solicitations,
We, therefore, propose that the communicating affiliate would be responsible for satisfying the notice requirement where applicable. Under the proposed rule, the communicating affiliate would have the flexibility either to give the notice directly or through an agent, or to provide a joint notice in conjunction with one or more other affiliates. This approach should facilitate the use of a single notice among affiliates. At the same time, it would ensure that the notice is not provided solely by the receiving affiliate, from which the consumer may not expect to receive important notices regarding the consumer's opt-out rights. We request comment on this approach generally, and whether it would provide consumers with reasonable notice. We also invite comment on whether the receiving affiliate should be permitted to give the notice solely on its own behalf. Commenters are also invited to discuss whether a notice solely from the receiving affiliate would effectively be a marketing solicitation because it constitutes that affiliate's first contact with the consumer. In addition, we invite comment on whether a notice from the receiving affiliate would be as effective as a notice from the communicating affiliate.
In defining the circumstances in which the notice and opt-out requirements apply, the proposal focuses on the communication of “eligibility information” among affiliates. The proposed definition of “eligibility information” would encompass any information that, if communicated, would be a “consumer report,” but for the FCRA's statutory exclusions for the sharing of transaction or experience information and for the sharing of information among affiliates.
Section 624(a)(4) of the FCRA also limits the scope of the notice and opt-out requirements by specifying that they do not apply when: (1) The affiliate receiving the information has a pre-existing business relationship with the consumer; (2) the information is used to perform services for another affiliate (subject to certain conditions); (3) the information is used in response to a communication initiated by the consumer; or (4) the information is used to make a solicitation that has been authorized or requested by the consumer.
Section 624(a)(3) of the FCRA provides that a consumer's affiliate marketing opt-out election shall be effective for at least five years.
As described below, an extension notice would be provided to the consumer at the end of the opt-out period if the receiving affiliate wishes to make marketing solicitations. Affiliated persons may wish to avoid the cost and burden of tracking five-year consumer opt-out periods with varying start and end dates, and delivering extension notices to each consumer at the appropriate time, by choosing to treat a consumer's opt-out election as effective for a period longer than five years, including indefinitely.
Proposed paragraph (a) of § 247.1 of Regulation S-AM specifically sets forth that the purpose of the proposed rules is to implement the affiliate marketing provisions of the FACT Act. Proposed paragraph (b) of § 247.1 lists the entities to which proposed Regulation S-AM would apply.
The FACT Act does not specifically identify which entities would be subject to the rules prescribed by the Commission.
Given the wide range of possible situations covered by Section 624 of the FCRA, the proposal includes general rules and provides more specific examples. These examples are intended to provide guidance about how the rules are likely to apply in specific situations, and to assist persons subject to the rules in understanding and complying with them. Proposed § 247.2 describes how examples are used in the proposed rules, and explains that the examples are not exclusive.
Proposed § 247.3 defines the following key terms used in proposed Regulation S-AM:
Proposed paragraph (a) of § 247.3 defines an “affiliate” of a Covered Person as any person that is related by common ownership or common corporate control with the Covered Person. The proposed rules also provide that a Covered Person would be considered an affiliate of another person for purposes of these rules if: (1) The other person is regulated under Section 214 of the FACT Act by one of the Agencies and (2) the rules adopted by that Agency treat the Covered Person as an affiliate of the other person.
The proposed definition of affiliate follows the definition of “affiliates” in Section 2 of the FACT Act: “persons that are related by common ownership or affiliated by corporate control.”
Proposed
Proposed paragraph (c) of § 247.3 defines “clear and conspicuous” to mean reasonably understandable and designed to call attention to the nature and significance of the information presented. While persons subject to proposed Regulation S-AM would have flexibility in determining how best to meet the clear and conspicuous standard, they may wish to consider a number of methods to make their notices clear and conspicuous.
A notice or disclosure could be made reasonably understandable through methods that include but are not limited to:
• Using clear and concise sentences, paragraphs, and sections;
• Using short explanatory sentences;
• Using bullet lists;
• Using definite, concrete, everyday words;
• Using active voice;
• Avoiding multiple negatives;
• Avoiding legal and highly technical business terminology; and
• Avoiding explanations that are imprecise and are readily subject to different interpretations.
• Using a plain-language heading;
• Using a typeface and type size that are easy to read;
• Using wide margins and ample line spacing; and
• Using boldface or italics for key words.
To be “clear and conspicuous,” a notice would need to be designed to call attention to the nature and significance of the information in it. When a notice or disclosure is combined with other information, design techniques to accomplish this could include the use of distinctive type sizes, styles, fonts, paragraphs, headings, graphic devices, groupings, or other devices. It would be unnecessary, however, to use distinctive features to differentiate an affiliate marketing opt-out notice from other components of a required disclosure (such as a privacy notice under the GLB Act that includes several opt-out disclosures in a single notice).
We recognize that it might not be feasible to employ all of the methods described above all of the time. For example, a person might need to use legal terminology, rather than everyday words, in some circumstances in order to provide a precise explanation. Although persons subject to proposed Regulation S-AM would not be required to consider the practices described above in designing their notices or disclosures, we encourage them to do so. We request comment on the proposed definition of “clear and conspicuous.”
Proposed paragraph (d) of § 247.3 defines “Commission” to mean the Securities and Exchange Commission.
Proposed paragraph (e) of § 247.3 defines “company,” as used in the definition of “affiliate,” as any corporation, limited liability company, business trust, general or limited partnership, association, or similar organization.
Proposed paragraph (f) of § 247.3 defines “consumer” to mean an individual, which follows the statutory definition in Section 603(c) of the FCRA.
Proposed paragraph (g) of § 247.3 defines “control” for purposes of Covered Persons to mean the power to exercise a controlling influence over the management or policies of a company, whether through ownership of securities, by contract, or otherwise.
Proposed paragraph (h) of § 247.3 defines “dealer” to have the same meaning as in Section 3(a)(5) of the Exchange Act,
Proposed paragraph (i) of § 247.3 defines “eligibility information” to mean any information the communication of which would be a consumer report if the exclusions from the definition of “consumer report” in Section 603(d)(2)(A) of the FCRA
Proposed paragraph (j) of § 247.3 defines “FCRA” to mean the Fair Credit Reporting Act.
Proposed paragraph (k) of § 247.3 defines “GLB Act” to mean the Gramm-Leach-Bliley Act.
Proposed paragraph (
Proposed paragraph (m) of § 247.3 defines “investment company” to have the same meaning as in Section 3 of the Investment Company Act of 1940 (“Investment Company Act”),
Proposed paragraph (n) of § 247.3 defines “marketing solicitation” to mean marketing initiated by a person to a particular consumer that is based on eligibility information communicated to that person by its affiliate, and that is intended to encourage the consumer to purchase a product or service. The proposed definition includes any form of communication, such as a telemarketing call, direct mail, or electronic mail, that is directed to a specific consumer based on that consumer's eligibility information. The proposed definition does not include communications that are directed at the general public without regard to eligibility information, even if those communications are intended to encourage consumers to purchase products and services. While the proposed definition tracks the definition in Section 624 of the FCRA, it does not follow the statute exactly. Modifications are intended to prevent confusion in the context of the federal securities laws.
Section 624 also authorizes the Commission to exclude other communications from the definition of “marketing solicitation.”
We also request comment on whether, and to what extent, various tools used in Internet marketing, such as pop-up ads, could constitute marketing solicitations as opposed to communications directed at the general public. Commenters are invited to discuss whether the Commission should provide persons subject to the rules with further guidance to address Internet marketing.
Proposed paragraph (o) of § 247.3 defines “person” to mean any individual, partnership, corporation, trust, estate, cooperative, association, government or governmental subdivision or agency, or other entity. A person could act through an agent, such as a licensed agent (in the case of an insurance company), a trustee (in the case of a trust), or any other agent. For purposes of this proposed rule, actions taken by an agent on behalf of a person that are within the scope of the agency relationship would be treated as actions of that person.
Proposed paragraph (p) of § 247.3 defines “pre-existing business relationship” to mean a relationship between a person and a consumer based on: (1) A financial contract between the person and the consumer that is in force; (2) the purchase, rental, or lease by the consumer of that person's goods or services, or a financial transaction (including holding an active account or a policy in force or having another continuing relationship) between the consumer and that person during the 18-month period immediately preceding the date on which a marketing solicitation is made or sent to the consumer; or (3) an inquiry or application by the consumer regarding a product or service offered by that person during the three-month period immediately preceding the date on which a marketing solicitation is made or sent to the consumer. While the proposed definition tracks the definition in Section 624 of the FCRA, it does not follow the statute exactly.
Section 624 also authorizes the Commission to recognize any other circumstances that would constitute a pre-existing business relationship.
Proposed paragraph (q) of § 247.3 defines “transfer agent” to have the same meaning as in Section 3(a)(25) of the Exchange Act.
Proposed paragraph (r) of § 247.3 defines entities within the scope of the proposed rules—brokers, dealers, investment companies, registered investment advisers, and registered transfer agents—as “you.” The term “you” is intended to make the rules easier to understand and to use.
Proposed § 247.20
Proposed paragraph (a) of § 247.20 would set forth the duty of a communicating affiliate. Under the proposal, before a receiving affiliate could use eligibility information to make or send marketing solicitations to a consumer, the communicating affiliate would have to provide a notice to the consumer stating that this information may be communicated to and used by the receiving affiliate for marketing purposes, and must give the consumer a reasonable opportunity to opt out through some simple method. The requirements of notice and opt-out would only apply if a receiving affiliate uses eligibility information for marketing purposes. Thus, the requirements of proposed paragraph (a) would not apply if no eligibility information is communicated to affiliates, or if no receiving affiliate uses eligibility information to make marketing solicitations.
Proposed paragraph (a) would not apply if, for example, a financing company affiliated with a broker-dealer asks the broker-dealer to include financing-company marketing materials in periodic statements sent to consumers by the broker-dealer without regard to eligibility information. We invite comment on whether, given the policy objectives of Section 214 of the FACT Act, proposed paragraph (a) should apply if affiliated companies seek to avoid providing notice and opt-out by engaging in the “constructive sharing” of eligibility information to conduct marketing. For example, we request commenters to consider the applicability of paragraph (a) in the following circumstances: A consumer has a relationship with a broker-dealer, and the broker-dealer is affiliated with a financing company. The financing company provides the broker-dealer with specific eligibility criteria, such as consumers having a margin loan balance in excess of $10,000, for the purpose of having the broker-dealer make solicitations on behalf of the financing company to consumers that meet those criteria. Additionally, the consumer responses provide the financing company with discernable eligibility information, such as a response form that is coded to identify the consumer as an individual who meets the specific eligibility criteria.
Proposed paragraph (a) also includes two “rules of construction” that give further guidance regarding how affiliate marketing notices might be provided to consumers. The first rule of construction would permit the notice to be provided either in the name of a person with which the consumer currently does or previously has done business, or in one or more common corporate names shared by members of an affiliated group of companies that includes the common corporate name used by that person. This rule of construction also would provide three alternatives regarding the manner in which the notice may be given. First, a communicating affiliate could provide the notice to the consumer directly. Second, a communicating affiliate could use an agent to provide the notice, so long as the agent provides the notice in the name of the communicating affiliate or in a common corporate name.
This rule of construction is intended to strike a balance by allowing some flexibility regarding which entity or entities within an affiliated group would provide the notice, while ensuring that the notice is meaningful and designed to be effective. An opt-out notice provided to a consumer solely in the name of a receiving affiliate is not likely to be effective because the name of the receiving affiliate would not be recognizable to the consumer as an entity with which the consumer does or has done business. For example, if the consumer has a relationship with “company ABC” but the opt-out notice is provided solely in the name of “company XYZ” (which does not share a common family name with company ABC), the notice is not likely to be effective. Indeed, many consumers might disregard a notice from company XYZ on the assumption that the notice was unsolicited junk mail. If, however, the consumer has a relationship with company ABC and the opt-out notice is provided jointly in the name of all affiliated companies that share the ABC name and the XYZ name, the notice is likely to be effective because the consumer would recognize the name of company ABC. We request comment on this first proposed rule of construction.
As explained above, more than one affiliated company may play the role of communicating affiliate with regard to the same set of eligibility information. Thus, the second rule of construction makes clear that it is not necessary for each affiliate that communicates the same eligibility information to provide an opt-out notice to the consumer, so long as the notice provided by the initial communicating affiliate is broad enough to cover the communication to, and marketing use by, all subsequent affiliates. For example, if affiliate A communicates eligibility information to affiliate B, and affiliate B communicates the same information to affiliate C, affiliate B does not have to provide the consumer with a separate opt-out notice, so long as affiliate A's notice was broad enough to cover both B's and C's use of that information. Proposed Regulation S-AM provides examples to illustrate how these “rules of construction” work. We request comment on this second proposed rule of construction.
Proposed paragraph (a) of § 247.20 contemplates that the opt-out notice would be provided to a consumer in writing or, if the consumer agrees, electronically. We request comment on whether there are circumstances in which oral notice and opt-out should be permitted. Commenters should indicate how an oral notice could satisfy the statutory “clear and conspicuous” standard.
Proposed paragraph (b) of § 247.20 sets forth the general duties of a receiving affiliate. In particular, a receiving affiliate could not use the eligibility information it receives from its affiliate to make marketing solicitations to a consumer unless, prior to such use the consumer has: (1) Been provided an opt-out notice (as described in paragraph (a) of § 247.20) that applies to that affiliate's use of eligibility information; (2) received a reasonable opportunity to opt out of that use through one or more simple methods; and (3) not opted out. We invite comment regarding the duties of a receiving affiliate.
The requirements of proposed paragraphs (a) and (b) of § 247.20 would only apply when the information communicated to affiliates meets the definition of “eligibility information,” which, as explained above, would incorporate the concept of a “consumer report,” from Section 603(d) of the FCRA.
Proposed paragraph (c) of § 247.20 incorporates the statutory exceptions to the affiliate marketing notice and opt-out requirements as set forth in Section 624(a)(4) of the FCRA. In particular, proposed paragraph (c) provides that the receiving affiliate need not comply with these requirements if: (1) It uses the information to make a marketing solicitation to a consumer with whom the affiliate has a pre-existing business relationship; (2) it uses the information to facilitate communications to an individual for whose benefit the affiliate provides employee benefit or other services under a contract with an employer related to and arising out of a current employment relationship or an individual's status as a participant or beneficiary of an employee benefit plan; (3) it uses the information to perform services for another affiliate, unless the services involve sending marketing solicitations on behalf of the other affiliate and that affiliate is not permitted to send such solicitations itself as a result of the consumer's decision to opt out; (4) it uses the information to make marketing solicitations in response to a communication initiated by the consumer; (5) it uses the information to make marketing solicitations in response to a consumer's request or authorization for a marketing solicitation; or (6) compliance with the requirements of proposed Regulation S-AM would prevent the affiliate from complying with any provision of state insurance laws pertaining to unfair discrimination in a state in which the affiliate is lawfully doing business.
Proposed paragraph (c)(1) clarifies that the notice and opt-out requirements of proposed Regulation S-AM would not apply when the receiving affiliate has a pre-existing business relationship with the consumer. As noted above, the term pre-existing business relationship would be defined to include situations in which: (1) The consumer has purchased, rented, or leased the affiliate's goods or services during the 18 months immediately preceding the date of the solicitation; or (2) the consumer has inquired about or applied for a product or service offered by the affiliate during the three-month period immediately preceding the date of the marketing solicitation.
Proposed paragraph (c)(3) of § 247.20 clarifies that the notice and opt-out requirements do not apply when the information is used to perform services for another affiliate. Of course, the exception would not apply if the other affiliate is not permitted to make or send marketing solicitations on its own behalf, for example as a result of the consumer's prior decision to opt out. Thus, when the notice has been provided to a consumer and the consumer has opted out, a receiving affiliate subject to the consumer's opt-out election could not circumvent the opt-out by instructing the communicating affiliate or another affiliate to make or send marketing
Proposed paragraph (c)(4) of § 247.20 provides that the notice and opt-out requirements do not apply when the information is used in response to a communication initiated by the consumer. The proposed rule clarifies that this exception could be triggered by an oral, electronic, or written communication initiated by the consumer. To be covered by the proposed exception, any use of eligibility information would need to be responsive to the communication initiated by the consumer. For example, if a consumer calls an affiliate to ask about retail locations and hours, the affiliate could not use eligibility information to make marketing solicitations to the consumer about specific products because those solicitations would not be responsive to the consumer's communication. Conversely, if the consumer calls an affiliate to ask about its products or services, marketing solicitations related to those products or services would be responsive to the communication and thus permitted under the exception. The time period during which marketing solicitations remain responsive to the consumer's communication would depend on the facts and circumstances. The proposal contemplates that a consumer has not initiated a communication if an affiliate makes the initial call and leaves a message for the consumer to call back, and the consumer responds. Proposed paragraph (d)(2) of § 247.20 provides examples of the consumer-initiated communications exception.
Proposed paragraph (c)(5) of § 247.20 provides that the notice and opt-out requirements do not apply when the information is used to make marketing solicitations that have been affirmatively authorized or requested by the consumer. This provision could be triggered by an oral, electronic, or written authorization or request by the consumer. Under the proposal, a pre-selected check box would not constitute an affirmative authorization or request. We also would not consider boilerplate language in a disclosure or contract to constitute affirmative authorization. The exception in proposed paragraph (c)(5) could be triggered, for example, if a consumer opens a securities account with a broker-dealer and authorizes or requests to receive marketing solicitations about insurance from an insurance affiliate of the broker-dealer. Under this proposed exception, the consumer could provide the authorization or make the request either through the person with whom the consumer has a business relationship or directly to the affiliate that would make the marketing solicitation.
The exceptions in proposed paragraphs (c)(1), (4), and (5) described above might overlap in certain situations. For example, if a consumer who has a securities account with a broker-dealer makes a telephone call to the broker-dealer's insurance affiliate and requests information about insurance, the insurance affiliate could use information about the consumer it obtains from the broker-dealer to make or send marketing solicitations in response to the telephone call. This could be done under the proposed exception in paragraph (c)(4) for responding to a communication initiated by the consumer. Because the consumer has made an inquiry to the insurance affiliate about its products and services, that inquiry could also trigger one of the possible proposed definitions of “pre-existing business relationship” as provided in paragraph (c)(1). In addition, the consumer's affirmative request could fit the proposed definition of a marketing solicitation authorized or requested by the consumer as provided in the exception in paragraph (c)(5). We request comment on the exceptions and examples in proposed paragraphs (c) and (d) of § 247.20.
Proposed paragraph (e) of § 247.20 provides that the notice and opt-out requirements of proposed Regulation S-AM do not apply to the use of eligibility information received by the receiving affiliate prior to the compliance date for these rules. The mandatory compliance date will be included in the final rules, if adopted. We request comment on what the mandatory compliance date should be and whether it should be different from the effective date of the final rules in order to permit institutions to incorporate the affiliate marketing notice into their next annual GLB Act privacy notice.
Finally, proposed paragraph (f) of § 247.20 clarifies the relationship between the affiliate sharing notice and opt-out under Section 603(d)(2)(A)(iii) of the FCRA and the affiliate marketing notice and opt-out required by new Section 624 of the FCRA.
Proposed § 247.21 addresses the contents of the opt-out notice. Proposed paragraph (a) of § 247.21 requires the opt-out notice to be clear, conspicuous, and concise, and to accurately disclose: (1) that the consumer may elect to limit a person's affiliate from using eligibility information about the consumer that the affiliate obtains from the person to make marketing solicitations to the consumer; and (2) if applicable, that the consumer's election will apply for a specified period of time and that the consumer will be allowed to extend the election once that period expires. The notice also would have to provide the consumer with a reasonable and simple method to opt out.
Proposed paragraph (b) of § 247.21 defines the term “concise” to mean a reasonably brief expression or statement. Proposed paragraph (b) also provides that a notice required by proposed Regulation S-AM could be concise even if it is combined with other disclosures required or authorized by federal or state law. Those disclosures include, but are not limited to, a notice under the GLB Act, a notice under Section 603(d)(2)(A)(iii) of the FCRA, and other similar consumer disclosures. In addition, paragraph (b) clarifies that the requirement for a concise notice would be satisfied by the appropriate use of one of the model forms in Appendix A of proposed Regulation S-AM. Use of the model forms, however, would not be required.
Proposed paragraph (c) of § 247.21 provides that the notice could allow a consumer to choose from a menu of alternatives when opting out, such as opting out of receiving marketing solicitations from certain types of affiliates, or from marketing solicitations that use certain types of information or are delivered using certain methods of communication. If a person provides a menu of alternatives, one alternative would have to allow the consumer to opt out with respect to all affiliates, all eligibility information, and all methods of delivering marketing solicitations.
Proposed paragraph (d) of § 247.21 provides that, if a person chooses to give consumers a broader opt-out right than is required by law, the person could modify the contents of the opt-out notice to reflect accurately the scope of the opt-out right it provides. Appendix A includes Model Form A-3, which might be helpful for persons that wish to allow consumers to prevent all marketing from that person and its affiliates. Use of the model form, however, would not be required. We invite comment on proposed § 247.21.
Proposed paragraph (a) of § 247.22 provides that the communicating affiliate would have to allow the consumer a “reasonable opportunity to opt out” after delivery of the opt-out notice and before the receiving affiliate uses eligibility information to make marketing solicitations to the consumer. Given the variety of circumstances in which opt-out rights are provided, a “reasonable opportunity to opt out” should be construed as a general test that avoids setting a mandatory waiting period. A general standard would provide flexibility to allow receiving affiliates to use eligibility information to make marketing solicitations at an appropriate point in time, while assuring that the consumer is given a realistic opportunity to prevent such use of the information. Examples are given to illustrate what might constitute a reasonable opportunity to opt out in different situations. Although 30 days may be reasonable in most cases, a person could choose to give consumers more than 30 days in which to decide whether to opt out.
Proposed paragraphs (b)(1), (2), and (3) of § 247.22 contain examples of reasonable opportunities to opt out. Proposed paragraphs (b)(1) and (2) contain examples of reasonable opportunities to opt out by mail or by electronic means, which are consistent with examples used in the GLB Act privacy rules.
Proposed paragraph (b)(4) of § 247.22 illustrates that including the affiliate marketing opt-out notice in a notice under the GLB Act could satisfy the reasonable opportunity standard. In this situation, the consumer should be allowed to exercise the opt-out in the same manner and should be given the same amount of time to exercise the opt-out as with respect to the GLB Act privacy notice. This example takes into account the statutory requirement that we consider methods for coordinating and combining notices.
Some persons subject to proposed Regulation S-AM might have a policy of not allowing affiliates to use eligibility information for marketing purposes unless a consumer affirmatively consents, or “opts in,” to receiving such marketing solicitations. Proposed paragraph (b)(5) of § 247.22 clarifies that an “opt-in” would meet the requirement to provide a reasonable opportunity to opt out, so long as the consumer's affirmative consent is documented. A pre-selected check box on a Web form or boilerplate language in a contract would not be evidence of the consumer's affirmative consent.
The proposed rules do not require persons to disclose in their opt-out notices how long a consumer has to opt out before a receiving affiliate could begin making marketing solicitations based on the consumer's eligibility information. In this respect, the proposed rules are consistent with the GLB Act privacy rules. Persons subject to proposed Regulation S-AM might choose to include such disclosures in their notices, however. We request comment on this approach.
Proposed paragraph (a) of § 247.23 sets forth examples of reasonable and simple methods of opting out. These examples generally track the examples of reasonable opt-out means from Section 7(a)(2)(ii) of the GLB Act privacy rules,
Proposed paragraph (b) of § 247.23 provides examples of methods of opting out that would not be reasonable and simple. These methods include requiring the consumer to write a letter or to call or write to obtain an opt-out form that was not included with the notice. In addition, a consumer who agrees to receive the opt-out notice in electronic form only, such as by electronic mail or at a Web site, would have to be allowed to opt out by the same or a substantially similar electronic form and should not be required to opt out solely by telephone or paper mail.
Proposed paragraph (a) of § 247.24 provides that a person would need to deliver its opt-out notices so that each consumer reasonably can be expected to receive actual notice. Under this proposal, opt-out notices that are
As indicated by the examples provided in proposed paragraph (b) of § 247.24, the “reasonable expectation of delivery” standard is a lesser standard than actual notice. For instance, if a communicating affiliate mails a printed copy of its notice to the last known mailing address of a consumer, it has met its obligation even if the consumer has changed addresses and never receives the notice.
Proposed paragraph (c) of § 247.24 permits a person to provide a joint opt-out notice with one or more of its affiliates, so long as the notice is accurate with respect to each affiliate that issues the joint notice. A joint notice would not have to list each affiliate participating in the joint notice by its name. If each affiliate shares a common name, such as “ABC,” then the joint notice could state that it applies to “all institutions with the ABC name” or “all affiliates in the ABC family of companies.” If, however, one or more affiliates does not have ABC in its name, the joint notice would need to separately identify each affiliate or each group of affiliates with a common name. We invite comment regarding this proposed approach to joint notices.
Proposed paragraph (d)(1) of § 247.24 sets out rules that apply when two or more consumers (referred to in the proposed regulation as “joint consumers”) jointly obtain a product or service, such as a joint securities account. In particular, a person could provide a single opt-out notice to joint accountholders. The notice would have to indicate whether the person will treat an opt-out election by one joint accountholder as applying to all of the associated accountholders, or whether each accountholder might opt out separately. The person could not require all accountholders to opt out before honoring an opt-out direction by one of the joint accountholders. Paragraph (d)(2) gives examples of the operation of these rules.
Proposed paragraph (d)(1)(vii) and the example in paragraph (d)(2)(iii) address the situation in which only one of two joint consumers has opted out. Those paragraphs are patterned after similar provisions in the GLB Act privacy rules.
Proposed § 247.25 addresses the duration and effect of a consumer's opt-out election. Proposed paragraph (a) of § 247.25 provides that a consumer's election to opt out is effective for the opt-out period, which is a period of at least five years beginning as soon as reasonably practicable after the consumer's opt-out election is received. Nothing in this paragraph limits the ability of affiliated persons to set an opt-out period of longer than five years, including an opt-out period that does not expire unless revoked by the consumer. No opt-out period, however, could be shorter than five years. If, for some reason, a consumer elects to opt out again while the opt-out period remains in effect, a new opt-out period of at least five years would begin upon receipt of each successive opt-out election.
Proposed paragraph (b) of § 247.25 provides that a receiving affiliate could not make or send marketing solicitations to a consumer during the opt-out period based on eligibility information it receives from an affiliate, except as provided in the exceptions in § 247.20(c)
Proposed paragraph (c) of § 247.25 clarifies that a consumer could opt out at any time. Thus, even if the consumer did not opt out in response to the initial opt-out notice or if the consumer's election to opt out is not prompted by an opt-out notice, the consumer could still opt out. Regardless of when the consumer opts out, the opt-out would have to be effective for at least five years.
Proposed paragraph (d) of § 247.25 describes how the termination of a consumer relationship affects the consumer's opt-out. Specifically, if a consumer's relationship with a person terminates for any reason when the consumer's opt-out election is in force, the opt-out would continue to apply indefinitely unless revoked by the consumer. We invite comment on proposed § 247.25.
Proposed § 247.26 describes the procedures for extending an opt-out. Proposed paragraph (a) of § 247.26 states that consumers would have to be provided with a new notice and a reasonable opportunity to extend their opt-out before a receiving affiliate could make marketing solicitations based on the consumer's eligibility information upon expiration of the opt-out period. The person who initially provided the notice, or its successor, would provide the extension notice. If an extension notice is not provided to the consumer, the opt-out period would continue indefinitely. The requirement to provide an extension notice upon expiration of the opt-out period would apply to any opt-out “ even, for example, if the consumer failed to opt out initially and informed the communicating affiliate of his or her opt-out at some later time. The consumer could extend the opt-out at the expiration of each successive opt-out period. Proposed paragraph (b) of § 247.26 provides that each opt-out extension would have to comply with § 247.25(a), which means that it would
Proposed paragraph (c) of § 247.26 addresses the contents of an extension notice.
Proposed paragraph (d) of § 247.26 addresses the timing of the extension notice. An extension notice can be delivered to the consumer either a reasonable period of time before the opt-out period expires, or any time after the opt-out period expires, but before covered marketing solicitations are made to the consumer. Providing the extension notice a reasonable period of time before the opt-out period expires would facilitate the smooth transition of consumers who choose to change their elections. An extension notice given too far in advance of the expiration of the opt-out period, however, might confuse consumers. We do not propose to set a fixed time for what would constitute a “reasonable period of time” to send an extension notice before the opt-out period expires. A reasonable period of time could depend upon the amount of time given to the consumer for a reasonable opportunity to opt out, the amount of time necessary to process opt-outs, and other factors. Nevertheless, providing an extension notice on or with the last annual privacy notice required by the GLB Act privacy provisions to be sent to the consumer before the opt-out period expires would be deemed reasonable in all cases. Proposed paragraph (e) of § 247.26 makes clear that sending an extension notice to the consumer before the expiration of the opt-out period would not shorten the five-year opt-out period.
Opt-out elections under the GLB Act do not expire, and GLB Act notices typically state that the consumer need not opt out again if the consumer previously opted out. Thus, including an affiliate marketing opt out notice or an extension notice on an initial or annual notice under the GLB Act raises special issues. If a person chooses to make the affiliate marketing opt-out effective in perpetuity, the statement in the GLB Act notice would remain correct. However, the GLB Act statement would not be accurate with respect to the extension notice if the affiliate marketing opt-out is limited to a defined period of five or more years. In that case, the extension notice would have to make clear to the consumer the necessity of opting out again in order to extend the opt-out. We request comment on this interaction between FACT Act and GLB notices, including on whether the Commission should provide further guidance regarding how a communicating affiliate might ensure that the difference in opt-out rights is clear to consumers.
Proposed § 247.27 implements Section 624(b) of the FCRA,
We request comment on whether persons subject to proposed Regulation S-AM would plan to consolidate their affiliate marketing notices with the GLB Act privacy notice or the affiliate sharing opt-out notice under Section 603(d)(2)(A)(iii) of the FCRA, whether we have provided sufficient guidance on consolidated notices, and whether consolidation would be helpful or confusing to consumers.
As noted above, we are proposing model forms as examples to illustrate how persons could comply with the notice and opt-out requirements of Section 624 of the FCRA and proposed Regulation S-AM. Appendix A includes three proposed model forms. Model Form A-1 is a proposed form of an initial opt-out notice. Model Form A-2 is a proposed form of an extension notice that could be used when the consumer's prior opt-out has expired or is about to expire. Model Form A-3 is a proposed form that persons subject to proposed Regulation S-AM could use if they offer consumers a broader right to opt out of marketing than is required by law.
Use of the model forms would not be mandatory. Persons subject to proposed Regulation S-AM could use the model forms, modify the model forms to suit particular circumstances, or use some other form, so long as the requirements of the proposed rules are met. For example, although Model Forms A-1 and A-2 use five years as the duration of the opt-out period, communicating affiliates could choose an opt-out period longer than five years and to substitute the longer time period in the opt-out notices. Alternatively, communicating affiliates could choose to treat the consumer's opt-out as effective in perpetuity and thereby omit from the initial notice any reference to the limited duration of the opt-out period or the right to extend the opt-out.
Each of the proposed model forms is designed as a stand-alone form. We anticipate that some persons might want to combine the affiliate marketing opt-out notice with a GLB Act privacy notice. If the notices are combined, we expect that persons would integrate the affiliate marketing opt-out notice with other required disclosures and avoid repetition of information such as the methods for opting out. Developing a model form that combines various opt-out notices, however, is beyond the scope of this rulemaking.
We request comment on all provisions of proposed Regulation S-AM described above, including suggestions for additional provisions or changes, and
The Commission is sensitive to the costs and benefits of its rules. Proposed Regulation S-AM would minimize compliance costs while enabling consumers to limit certain marketing solicitations from affiliated companies. The proposed rules would implement Section 214 of the FACT Act and would impose no significant costs beyond those required under the FACT Act. The Commission encourages comment to identify, discuss, analyze, and supply relevant data regarding the costs and benefits stemming from compliance with the proposed rules.
The proposed rules would require that consumers be provided with notice and an opportunity to opt out of receiving marketing solicitations that are based on the communication of the consumer's eligibility information
The proposed rules would impose costs upon Covered Persons
The proposed rules include several considerations that would minimize compliance costs for affected persons. First, as required by the FACT Act, the proposed rules would allow Covered Persons to combine their affiliate marketing opt-out notices with any other notice required by law, including the privacy notices required under the GLB Act.
According to Commission filings, there are approximately 6,768 broker-dealers, 5,182 investment companies, 7,977 registered investment advisers, and 443 registered transfer agents that could be subject to the proposed rules. However, whether a Covered Person actually would be required to provide notice and opt-out would depend on the information sharing policies of that person and the marketing policies of its affiliates.
If an institution is required to provide consumers notice and an opportunity to opt out, the notice could be combined with GLB Act privacy notices or with any other document, including other disclosure documents or account statements. We expect that most institutions that would be required to provide an affiliate marketing notice would combine that notice with some other form of communication.
For purposes of the Paperwork Reduction Act, we have estimated that 14,259 affiliated persons each would require 1 hour on average to review its information sharing and affiliate marketing policies and practices to determine whether notice and opt-out would be necessary. Assuming a cost of $125 per hour for managerial staff time, the total one-time cost of review would be approximately $1,782,375 (14,259 × $125). Once the review is complete, we have estimated that 2,037 Covered Persons actually would be required to provide notice and opt-out, and that those persons would need an average of 6 hours to provide initial notice and opt-out and 2 hours to design notices for new customers to receive on an ongoing
We request comment that may assist in quantifying the costs and the benefits identified in this analysis. With regard to costs, please delineate start-up costs (including costs to update existing systems) as well as ongoing annual costs. We also request comment on any costs and benefits of proposed Regulation S-AM not identified here. We specifically invite comment on and data regarding the Commission's estimates that 70% of Covered Persons have affiliates and 10% of Covered Persons would be required to provide consumers with notice and opt-out under the proposed rules. We further request comment on and data regarding the anticipated costs of drafting affiliate marketing privacy notices and of implementing systems for tracking opt-outs and providing extension notices upon expiration of the opt-out period. We invite comment on and data regarding the likelihood of including affiliate marketing notices in other mailings, on the cost of combined versus stand-alone mailings, and on any anticipated savings due to the electronic transmission of affiliate marketing notices and opt-outs.
Certain provisions of the proposed rules may constitute a “collection of information” within the meaning of the Paperwork Reduction Act of 1995, 44 U.S.C. 3501
Before a receiving affiliate could make marketing solicitations based on the communication of eligibility information from a communicating affiliate, the communicating affiliate would be required to provide a notice to each affected individual informing the individual of his or her right to prohibit such marketing. In addition, as a practical matter in order for the opt-outs to be effective, one or both affiliates would need to keep records of any opt-out elections. If the receiving affiliate intends to resume making marketing solicitations based on eligibility information upon expiration of the opt-out period, the communicating affiliate also would need to send an expiration notice and enable the consumer to extend the opt-out election if desired.
In drafting the proposed rules, we have attempted to retain procedural flexibility and to minimize compliance burdens except as required by the terms of the FACT Act. We believe that the proposed rules do not impose significant burdens in excess of the statutory requirements.
New Section 624 of the FCRA Act is intended to enhance the protection of consumer financial information in the affiliate marketing context and to enable consumers to limit marketing solicitations from affiliated companies that are based on eligibility information. Proposed Regulation S-AM is necessary to fulfill Congress' mandate in Section 214 of the FACT Act that the Commission must prescribe regulations to implement Section 624.
According to Commission filings, there are approximately 6,768 broker-dealers, 5,182 investment companies, 7,977 registered investment advisers, and 443 registered transfer agents that could be subject to the proposed rules. However, we expect that only a fraction of all Covered Persons would be required to provide notice and opt-out to consumers. First, the proposed rules only apply to Covered Persons that have affiliates, and then only if receiving affiliates make marketing solicitations based on the communication of eligibility information. Based on a review of forms filed with the Commission, we estimate that approximately 70% of Covered Persons have a corporate affiliate.
Every Covered Person that has one or more affiliates likely would incur a one-time burden in reviewing its policies and business practices to determine the extent to which it communicates eligibility information to affiliates for marketing purposes and whether those affiliates make marketing solicitations based on the communication of that eligibility information. This determination should be straightforward for most entities, in part because the GLB Act privacy regulations already require Covered Persons to review their information sharing practices and disclose whether they share information with affiliates.
We have estimated that 2,037 Covered Persons would be required to provide notice and opt-out under the proposed rules. This process would consist of several steps. First, the affiliated person would need to create an affiliate marketing notice. The amount of time required to develop a notice should be reduced significantly by the inclusion of model forms in the proposed rules. Second, the notices would need to be delivered. The proposed rules allow that affiliate marketing notices could be combined with any other notice or disclosure required by law. We expect that most persons subject to proposed Regulation S-AM would combine their affiliate marketing notices with some other form of communication, such as an account statement or an annual notice under the GLB Act. Because those communications are already delivered to consumers, adding a brief affiliate marketing notice should not result in added costs for processing or for postage and materials.
Because the notice and opt-out requirements represent a prerequisite to covered forms of affiliate marketing, most affected persons would provide notice within the first year after compliance with the proposed regulations would be required. However, additional notices may be required on a smaller scale as new customer relationships are formed. We anticipate that many affected persons would ensure delivery to new consumers with a minimum of additional effort by integrating the notices as a permanent part of account opening documents, initial privacy notices under the GLB Act, or some other form of regular communication. Accordingly, we estimate a one-time average burden of 2 hours for affected entities to create the notices (4,074 hours total) and an ongoing annual burden of 2 hours per year (4,074 hours total) to deliver the notices to new consumers and to record any opt-outs.
A consumer opt-out may expire at the end of five years, as long as the person that provided the initial notice provides the consumer with renewed notice and an opportunity to extend his or her opt-out election before any affiliate marketing may begin.
In sum, we estimate that each of 14,259 affiliated persons would require an average one-time burden of 1 hour to review affiliate marketing practices (14,259 hours total). We estimate that the approximately 2,037 persons required to provide notice and opt-out would incur an average first-year burden of 6 hours to provide notice and allow for consumer opt-outs, for a total estimated first-year burden of 12,222 hours. With regard to continuing notice burdens, we estimate that each of the approximately 2,037 persons required to provide notice and opt-out would incur a one-time burden of 2 hours to develop notices for new consumers (4,074 hours total) and an annual burden of 2 hours to deliver the notices and record any opt-outs (4,074 hours total). These estimates would represent a total one-time burden of 18,333 hours (14,259 plus 4,074), a total first-year burden of 12,222 hours, and an ongoing annual burden of 4,074 hours. Averaged across the first three years for which compliance would be required, the total average yearly burden would be 11,543 hours. We do not expect that Covered Persons will incur start-up or materials costs in addition to the staff time discussed above.
In addition to the general request for comment reflected below, we request comment on these estimates of the annual reporting and recordkeeping burdens. How many Covered Persons share eligibility information with affiliates that the affiliates use to send marketing solicitations? Are there exceptions to the notice requirements under proposed Regulation S-AM on which many Covered Persons are likely to rely? Are affiliated families of companies likely to review the sharing and marketing policies of their affiliates on an organizational basis, or is each affiliate likely to review its own policies? Are affiliated families of companies likely to provide a single joint notice covering all affiliates? Are Covered Persons likely to consolidate notices required under proposed Regulation S-AM with GLB Act privacy notices or with other customer communications? Are Covered Persons likely to extend the opt-out period for more than five years?
The proposed rules do not contain express provisions governing the retention of records related to opt-outs. However, the example discussing consumer “opt-ins” in § 247.22(b)(5) of the proposed rules would state that any opt-in must be documented. Moreover, as noted above, a person subject to proposed Regulation S-AM would need to keep some record of consumer opt-outs in order to know which consumers should not receive marketing solicitations based on eligibility information. These records would need to be retained for at least as long as the opt-out period of five or more years, so that the person responsible for providing the extension notice would know when that notice is required.
As noted, only Covered Persons that communicate eligibility information to their affiliates for marketing purposes would be required to comply with the notice and opt-out provisions of the proposed rules. However, assuming that no other exception applies, the disclosure and recordkeeping requirements are mandatory with respect to those persons.
The affiliate marketing notices and opt-out records would not be filed with or otherwise submitted to the Commission. Accordingly, we make no
Pursuant to 44 U.S.C. 3506(c)(2)(B), the Commission solicits comment to:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have practical utility;
(2) Evaluate the accuracy of the Commission's estimate of the burden of the proposed collection of information;
(3) Determine whether there are ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) Determine whether there are ways to minimize the burden of the collection of information on those who are to respond, including through the use of automated collection techniques or other forms of information technology.
Persons wishing to submit comments on the collection of information requirements should direct them to the following persons: (1) Desk Officer for the Securities and Exchange Commission, Office of Information and Regulatory Affairs, Office of Management and Budget, Room 3208, New Executive Office Building, Washington, DC 20503; and (2) Jonathan G. Katz, Secretary, Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC 20549. Any comments should make reference to File Number S7-29-04. OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication, so a comment to OMB is best assured of having its full effect if OMB receives it within 30 days after publication. Requests for materials submitted to OMB by the Commission with regard to this collection of information should be made in writing, should refer to File Number S7-29-04, and should be submitted to the Securities and Exchange Commission, Records Management, Office of Filings and Information Services, 450 Fifth Street, NW., Washington, DC 20549.
The Regulatory Flexibility Act
Section 214 of the FACT Act (which adds new Section 624 to the FCRA) generally prohibits a person from using certain information received from an affiliate to make marketing solicitations to a consumer, unless the consumer is given notice, as well as an opportunity and a simple method to opt out, of the possibility of receiving such solicitations. Section 214 also requires the Agencies and the Commission, in consultation and coordination with one another, to issue implementing regulations that are consistent and comparable to the extent possible. Proposed Regulation S-AM is comparable in all substantive respects to the proposed rules published by the Agencies. The Background and Explanation of the Proposed Rules at Sections I-II above further describe the reasons why the regulation is being proposed.
The proposed rules would implement Section 214 of the FACT ACT, which protects the privacy of consumer financial information by providing that consumers must receive notice and an opportunity to opt out before affiliated companies engage in marketing based on the sharing of certain consumer information. The objectives of the proposed rules are discussed in detail in the Background, Explanation of the Proposed Rules, and Section-by-Section Analysis at Sections I-III above. The legal basis for the proposed rules is Section 214 of the FACT Act,
The proposed rules would apply to any Covered Person that communicates eligibility information to an affiliate or receives eligibility information from an affiliate for the purpose of using the information to make marketing solicitations. Of the entities registered with the Commission, 808 broker-dealers, 233 investment companies, 579 registered investment advisers, and 170 registered transfer agents are considered small entities.
The proposed rules require entities subject to Section 624 of the FCRA to provide consumers with notice and an opportunity to opt out of affiliated persons' use of eligibility information for marketing purposes. The proposed rules require specific duties on the part of two groups of covered persons: communicating affiliates and receiving affiliates. The communicating affiliate would be responsible for providing the opt-out notice to consumers, as specified in the proposed rules. The receiving affiliate must not make marketing solicitations to consumers
For those entities that provide the Section 624 notice in consolidation with notices under the GLB Act or other federally mandated disclosures, the proposed rules impose very limited additional reporting or recordkeeping requirements. However, for persons that choose to send the notices separately, the reporting and recordkeeping requirements may be more substantial. Although the proposed rules do not include specific recordkeeping requirements, in practice some system of recordkeeping must exist to ensure that any consumer opt-outs are honored.
Any analysis of the impact of the FACT Act and the proposed implementing regulations must take into consideration that the law is limited in scope. First, the new law only applies to the use of eligibility information by affiliates for the purpose of making marketing solicitations. Thus, affiliates that market based solely upon their own information or without regard to eligibility information are not affected by this law. Second, the law provides a number of exceptions, including by permitting affiliated persons to market to consumers with whom they have a “pre-existing business relationship” or from whom they have received a request for information.
A number of alternatives exist that could reduce the costs associated with compliance with the proposed rule. First, significant cost savings may be obtained by consolidating affiliate marketing notices with GLB Act privacy notices or with some other form of communication, such as account statements. In addition, we have included model forms for opt-out notices that would comply with the requirements of the proposed rules and that each person could customize to suit its needs if necessary. Furthermore, the proposed rules would permit affected persons to reduce recordkeeping requirements by offering a permanent opt-out from both the sharing of information between affiliates and from receiving marketing based on such sharing, which would be consistent with both the GLB Act and FCRA opt-outs as well as the affiliate marketing opt-out. Small entities may wish to consider whether consolidation of their notices and opt-outs can reduce their compliance costs. Similar considerations can reduce the burden of providing notice to new consumers. For example, small entities can combine affiliate marketing notices with account opening documents or initial privacy notices under the GLB Act in order to ensure that notices are delivered to new consumers without substantial additional efforts on the part of the affected person.
The Commission is concerned about the potential impact of the proposed rules on small entities. We request comment on the potential impact of any or all of the provisions in the proposed rules, including any benefits and costs, that the Commission should consider, as well as the costs and benefits of any alternatives, paying special attention to the effect of the proposed rules on small entities in light of the above analysis. Costs to implement and to comply with the proposed rules could include any expenditure of time or money for, for example, employee training, legal counsel, or other professional time; for preparing and processing the notices; and for recording and tracking consumers' elections to opt out.
With the exception of the opt-out for affiliate sharing under Section 603(d)(2)(A)(iii) of the FCRA, we have been unable to identify any federal statutes or regulations that would duplicate, overlap, or conflict with the proposed rules. The overlap of the proposed rules with the affiliate sharing provisions of the FCRA is discussed in the Explanation of the Proposed Rules and the Section-by-Section Analysis at Sections II-III above. We seek comment regarding any other statute or regulation, including state or local statutes or regulations, that would duplicate, overlap, or conflict with the proposed rules.
The Regulatory Flexibility Act directs the Commission to consider significant alternatives that would accomplish the stated objectives while minimizing any significant adverse impact on small businesses. In connection with the proposed rules, the Commission considered the following alternatives: (i) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (ii) the clarification, consolidation, or simplification of compliance and reporting requirements under the proposed rules for small entities; (iii) the use of performance rather than design standards; and (iv) an exemption from coverage of the proposed rules, or any part thereof, for small entities.
The Commission does not presently believe that an exemption from coverage or special compliance or reporting requirements for small entities would be consistent with the mandates of the FACT Act. Section 214 of the FACT Act addresses the protection of consumer privacy, and consumer privacy concerns do not depend on the size of the entity involved. However, we have endeavored throughout the proposed rules to minimize the regulatory burden on all Covered Persons, including small entities, while meeting the statutory requirements. Small entities should benefit from the existing emphasis on performance rather than design standards throughout the proposed rules and the use of examples, including model forms for affiliate marketing notices. The Commission welcomes comment on any alternative system that would be consistent with the FACT Act but would minimize the impact on small entities. Comments should describe the nature of any impact on small entities and provide empirical data to support the existence of the impact.
Section 3(f) of the Exchange Act and Section 2(c) of the Investment Company Act require the Commission, whenever it engages in rulemaking and must consider or determine if an action is necessary or appropriate in the public interest, to consider, in addition to the protection of investors, whether the action would promote efficiency, competition, and capital formation. In addition, Section 23(a)(2) of the Exchange Act requires the Commission, when proposing rules under the Exchange Act, to consider the impact the proposed rules may have upon competition. Section 23(a)(2) of the Exchange Act prohibits the Commission from adopting any rule that would impose a burden on competition that is not necessary or appropriate in furtherance of the purposes of the Exchange Act.
We do not believe the proposed rules would result in anti-competitive effects. The proposed rules, which implement Section 214 of the FACT Act, would apply to all brokers, dealers, investment companies, registered investment advisers, and registered transfer agents. All other affiliated persons that make marketing solicitations based on the communication of eligibility information between affiliates would be subject to the substantially similar rules proposed by the Agencies. Therefore, all persons that engage in affiliate marketing based on eligibility information would be required to bear the costs of implementing the proposed rules or substantially similar rules. Although these costs would vary among
Moreover, we believe the proposed rules would have little effect on efficiency and capital formation. We have estimated that the proposed rules would result in some additional costs for persons that make marketing solicitations based on the communication of eligibility information by affiliates and on the affiliates that communicate that information. Nevertheless, we believe the additional costs are small enough that they would not affect the efficiency of these entities.
The Commission seeks comment regarding the impact of the proposed rules on efficiency, competition, and capital formation. For purposes of the Small Business Regulatory Enforcement Fairness Act of 1996, the Commission also requests information regarding the potential effect of the proposed rules on the U.S. economy on an annual basis. Commentators are requested to provide empirical data to support their views.
The Commission is proposing Regulation S-AM under the authority set forth in Section 214 of the FACT Act,
Affiliate marketing, Brokers, Dealers, Investment advisers, Investment companies, Transfer agents, Reporting and recordkeeping requirements.
For the reasons set out in the preamble, the Commission proposes to amend Title 17, Chapter II of the Code of Federal Regulations by adding part 247 to read as follows:
15 U.S.C. 1681s-3 and note; 15 U.S.C. 78q, 78w, 78mm, 80a-30(a), 80a-37, 80b-4, and 80b-11.
(a)
(b)
The examples in this part are not exclusive. The examples in this part provide guidance concerning the rule's application in ordinary circumstances. The facts and circumstances of each individual situation, however, will determine whether compliance with an example constitutes compliance with the applicable rule. Examples in a paragraph illustrate only the issue described in the paragraph and do not illustrate any other issue that may arise.
As used in this part, unless the context requires otherwise:
(a)
(1) That company is regulated under section 214 of the FACT Act, Pub. L. No. 108-159, 117 Stat. 1952 (2003), by a government regulator other than the Commission; and
(2) Rules adopted by the other government regulator under section 214 of the FACT Act treat the broker, dealer, or investment company, or investment adviser or transfer agent registered with the Commission as an affiliate of that company.
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
(l)
(m)
(n)
(i) Based on eligibility information communicated to that person by its affiliate as described in this part; and
(ii) Intended to encourage the consumer to purchase or obtain such product or service.
(2)
(3)
(o)
(p)
(1) A financial contract between the person and the consumer which is in force on the date on which the consumer is sent a marketing solicitation covered by this part;
(2) The purchase, rental, or lease by the consumer of the person's goods or services, or a financial transaction (including holding an active account or a policy in force or having another continuing relationship) between the consumer and the person, during the 18-month period immediately preceding the date on which a marketing solicitation covered by this part is made or sent to the consumer; or
(3) An inquiry or application by the consumer regarding a product or service offered by that person during the 3-month period immediately preceding the date on which a marketing solicitation covered by this part is made or sent to the consumer.
(q)
(r)
(1) Any broker or dealer;
(2) Any investment company;
(3) Any investment adviser registered with the Commission under the Investment Advisers Act of 1940 (15 U.S.C. 80b-1
(4) Any transfer agent registered with the Commission under section 17A of the Securities Exchange Act of 1934 (15 U.S.C. 78q-1).
(a)
(i) You provide a clear and conspicuous notice to the consumer stating that the information may be communicated to and used by your affiliate to make or send marketing solicitations to the consumer about its products and services;
(ii) You provide the consumer a reasonable opportunity and a simple method to “opt out” of such use of that information by your affiliate; and
(iii) The consumer has not chosen to opt out.
(2)
(A) You may provide the notice directly to the consumer;
(B) Your agent may provide the notice on your behalf, so long as:
(
(
(C) You may provide a joint notice with one or more of your affiliates or under a common corporate name or names used by the family of companies as provided in § 247.24(c).
(ii)
(iii)
(A) Permit B to use the information to make marketing solicitations if:
(
(
(B) Permit B or C to use the information to make marketing solicitations if:
(
(
(C) Not permit B or C to use the information to make marketing solicitations if B has provided the opt-out notice only in B's own name, because no notice would have been provided by or on behalf of A.
(b)
(c)
(1) To make or send a marketing solicitation to a consumer with whom
(2) To facilitate communications to an individual for whose benefit you provide employee benefit or other services pursuant to a contract with an employer related to and arising out of the current employment relationship or status of the individual as a participant or beneficiary of an employee benefit plan;
(3) To perform services on behalf of an affiliate, except that this shall not be construed as permitting you to make or send marketing solicitations on your behalf or on behalf of an affiliate if you or the affiliate, as applicable, would not be permitted to make or send the marketing solicitation as a result of the election of the consumer to opt out under this part;
(4) In response to a communication initiated by the consumer orally, electronically, or in writing;
(5) In response to an affirmative authorization or request by the consumer orally, electronically, or in writing to receive a marketing solicitation; or
(6) If your compliance with this part would prevent you from complying with any provision of state insurance laws pertaining to unfair discrimination in any state in which you are lawfully doing business.
(d)
(i) If a consumer has an insurance policy with your insurance affiliate that is currently in force, your insurance affiliate has a pre-existing business relationship with the consumer and can therefore use eligibility information it has received from you to make marketing solicitations.
(ii) If a consumer has an insurance policy with your insurance affiliate that has lapsed, your insurance affiliate has a pre-existing business relationship with the consumer for 18 months after the date on which the policy ceases to be in force and can therefore use eligibility information it has received from you to make marketing solicitations for 18 months after the date on which the policy ceases to be in force.
(iii) If a consumer applies to your affiliate for a product or service, or inquires about your affiliate's products or services and provides contact information to your affiliate for receipt of that information, your affiliate has a pre-existing business relationship with the consumer for 3 months after the date of the inquiry or application and can therefore use eligibility information it has received from you to make marketing solicitations for 3 months after the date of the inquiry or application.
(iv) If a consumer makes a telephone call to a centralized call center for an affiliated group of companies to inquire about the consumer's securities account, the call does not constitute an inquiry with any affiliate other than the broker-dealer that holds the consumer's securities account and does not establish a pre-existing business relationship between the consumer and any affiliate of the broker-dealer.
(2)
(ii) If your affiliate makes the initial marketing call, leaves a message for the consumer to call back, and the consumer responds, the communication is not initiated by the consumer, but by your affiliate.
(iii) If the consumer calls your affiliate to ask about retail locations and hours, but does not request information about your affiliate's products or services, marketing solicitations by your affiliate using eligibility information about the consumer it obtains from you would not be responsive to the consumer-initiated communication.
(3)
(e)
(f)
(a)
(1) That the consumer may elect to limit your affiliate from using eligibility information about the consumer that it obtains from you to make or send marketing solicitations to the consumer;
(2) If applicable, that the consumer's election will apply for a specified period of time and that the consumer will be allowed to extend the election once that period expires; and
(3) A reasonable and simple method for the consumer to opt out.
(b)
(2)
(3)
(c)
(d)
(a)
(b)
(1)
(2)
(3)
(4)
(5)
(a)
(1) Designate check-off boxes in a prominent position on the relevant forms included with the opt-out notice required by this part;
(2) Include a reply form and a self-addressed envelope together with the opt-out notice required by this part;
(3) Provide an electronic means to opt out, such as a form that can be electronically mailed or processed at your Web site, if the consumer agrees to the electronic delivery of information; or
(4) Provide a toll-free telephone number that consumers may call to opt out.
(b)
(1) Require the consumer to write his or her own letter to you;
(2) Require the consumer to call or write to you to obtain a form for opting out, rather than including the form with the notice; or
(3) Require the consumer who agrees to receive the opt-out notice in electronic form only, such as by electronic mail or at your Web site, to opt out solely by telephone or by paper mail.
(a)
(b)
(i) Hand-deliver a printed copy of the notice to the consumer;
(ii) Mail a printed copy of the notice to the last known mailing address of the consumer; or
(iii) For the consumer who obtains a product or service from you electronically, such as on an Internet Web site, post the notice on your electronic site and require the consumer to acknowledge receipt of the notice as a necessary step to obtaining a particular product or service.
(2) You may not reasonably expect that a consumer will receive actual notice if you:
(i) Only post a sign in your branch or office or generally publish advertisements presenting your notice; or
(ii) Send the notice via electronic mail to a consumer who has not agreed to the electronic delivery of information.
(c)
(2)
(d)
(i) You may provide a single opt-out notice.
(ii) Any of the joint consumers may exercise the right to opt out.
(iii) You may either:
(A) Treat an opt-out direction by a joint consumer as applying to all of the associated joint consumers; or
(B) Permit each joint consumer to opt out separately.
(iv) If you permit each joint consumer to opt out separately, you must permit:
(A) One of the joint consumers to opt out on behalf of all of the joint consumers; and
(B) One or more joint consumers to notify you of their opt-out directions in a single response.
(v) You must explain in your opt-out notice which of the policies in paragraph (d)(1)(iii) of this section you will follow, as well as the information required by paragraph (d)(1)(iv) of this section.
(vi) You may not require
(vii) If you receive an opt-out by a particular joint consumer that does not apply to the others, you may use eligibility information about the others as long as no eligibility information is used about the consumer who opted out.
(2)
(i) Treat an opt-out direction by A as applying to the entire account. If you do so and A opts out, you may not require B to opt out as well before implementing A's opt-out direction.
(ii) Treat A's opt-out direction as applying to A only. If you do so, you must also permit:
(A) A and B to opt out for each other; and
(B) A and B to notify you of their opt-out directions in a single response (such as on a single form) if they choose to give separate opt-out directions.
(iii) If A opts out only for A, and B does not opt out, your affiliate may use information only about B to send marketing solicitations to B, but may not use information about A and B jointly to send marketing solicitations to B.
(a)
(b)
(c)
(d)
(a)
(b)
(c)
(1) The same contents specified in § 247.21(a) for the initial notice, along with a statement explaining that the consumer's previous opt-out has expired or is about to expire, as applicable, and that the consumer must opt out again if the consumer wishes to keep the opt-out election in force; or
(2) Each of the following items:
(i) That the consumer previously elected to limit your affiliate from using information about the consumer that it obtains from you to make or send marketing solicitations to the consumer;
(ii) That the consumer's election has expired or is about to expire, as applicable;
(iii) That the consumer may elect to extend the consumer's previous election; and
(iv) A reasonable and simple method for the consumer to opt out.
(d)
(i) A reasonable period of time before the expiration of the opt-out period; or
(ii) Any time after the expiration of the opt-out period but before any affiliate makes or sends marketing solicitations to the consumer that would have been prohibited by the expired opt-out.
(2)
(e)
(a)
(b)
• You may limit our affiliates from marketing their products or services to you based on information that we share with them, such as your income, your account history with us, and your credit score.
• [Include if applicable.] Your decision to limit marketing offers from our affiliates will apply for 5 years. Once that period expires, you will be allowed to extend your decision.
• [Include if applicable.] This limitation does not apply in certain circumstances, such as if you currently do business with one of our affiliates or if you ask to receive information or offers from them.
To limit marketing offers [include all that apply]:
• Call us toll-free at 877-###-####; or
• Visit our Web site at
• Check the box below and mail it to:
_I do not want your affiliates to market their products or services to me based on information that you share with them.
• You previously chose to limit our affiliates from marketing their products or services to you based on information that we share with them, such as your income, your account history with us, and your credit score.
• Your choice has expired or is about to expire.
• [Include if applicable.] This limitation does not apply in certain circumstances, such as if you currently do business with one of our affiliates or if you ask to receive information or offers from them.
To extend your choice for another 5 years [include all that apply]:
• Call us toll-free at 877-###-####; or
• Visit our Web site at
• Check the box below and mail it to:
_I want to extend my choice for another 5 years.
• You may choose to stop all marketing offers from us and our affiliates.
To stop all marketing offers [include all that apply]:
• Call us toll-free at 877-###-####; or
• Visit our Web site at
• Check the box on the form below and mail it to:
_I do not want you or your affiliates to send me marketing offers.
By the Commission.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to address the traveling needs of persons on oxygen therapy by permitting the use of certain portable oxygen concentrator devices on aircraft, providing certain conditions are satisfied.
Send your comments on or before August 13, 2004.
Address your comments to the Docket Management System, U.S. Department of Transportation, Room Plaza 401, 400 Seventh Street, SW., Washington, DC 20590-0001. You must identify the docket number FAA-2004-18596 at the beginning of your comments, and you should submit two copies of your comments. If you wish to receive confirmation that FAA received your comments, include a self-addressed, stamped postcard.
You may also submit comments through the Internet to
James W. Whitlow, Office of the Chief Counsel, AGC-2, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone (202) 267-3222; facsimile (202) 267-3227.
All comments received, as well as a report summarizing each substantive public contact with DOT personnel concerning this proposed rulemaking, will be filed in the docket. The docket is available for public inspection before and after the comment closing date.
All comments received on or before the closing date will be considered by FAA before taking action on this proposed rulemaking. Comments filed late will be considered as far as possible without incurring expense or delay. The proposals in this document may be changed in light of the comments received.
Commenters wishing FAA to acknowledge receipt of their comments submitted in response to this document must include a pre-addressed, stamped postcard with those comments on which the following statement is made: “Comments to Docket No. FAA-2004-18596.” The postcard will be date stamped and mailed to the commenter.
You can get an electronic copy using the Internet by taking the following steps:
(1) Go to the search function of the Department of Transportation's electronic Docket Management System (DMS) web page (
(2) On the search page type in the last four digits of the Docket number shown at the beginning of this notice. Click on “search.”
(3) On the next page, which contains the Docket summary information for the Docket you selected, click on the document number of the item you wish to view.
The FAA is proposing this Special Federal Aviation Regulation (SFAR) to address the traveling needs of persons on oxygen therapy. The FAA has been made aware of the critical need for improved service to passengers who must travel with oxygen while on the aircraft. Consequently, the FAA is proposing this SFAR to permit the use of certain portable oxygen concentrator devices on aircraft, provided certain conditions are satisfied. The NPRM proposes to limit the SFAR to the AirSep LifeStyle Portable Oxygen Concentrator because this is the only device of this type the FAA has evaluated and determined to be safe. Other devices may be added to the SFAR after the FAA has been satisfied that they can be safely used on board aircraft. The FAA seeks comments, particularly technical information about other assistive devices which may be of benefit to users of medical oxygen delivery systems, to enable the FAA to evaluate the safety of these devices and the feasibility of including these devices in the SFAR. In order for an oxygen delivery system to be considered safe by the FAA for use onboard an aircraft, at a minimum the Research and Special Programs Administration (RSPA) must first determine that the device does not contain hazardous materials and is not subject to its hazardous materials regulations.
Currently, 14 CFR 121.574, 125.219, and 135.91 allow a passenger to carry and operate equipment generating, storing or dispensing medical oxygen on board an aircraft only if the equipment is furnished by the certificate holder and certain other conditions are satisfied. The oxygen furnished in compliance with these regulations is compressed oxygen, which is regulated as a hazardous material in transportation by the RSPA. Several of the conditions contained in §§ 121.574, 125.219, and 135.91 are designed to ensure that the oxygen cylinder is in compliance with RSPA's hazardous materials regulations. Other conditions are designed to ensure that the oxygen is dispensed safely while in use on the aircraft. Currently, air carriers are not required to provide medical oxygen and many regional carriers and some larger carriers do not provide this service. Those carriers that do allow passengers to use the medical oxygen typically provide the compressed oxygen themselves and charge a fee for this service.
Over the last two years, a new portability technology for dispensing medical oxygen to users has been brought to the FAA's attention— (1) the AirSep Corporation's LifeStyle Portable Oxygen Concentrator (POC), which is the first unit to be evaluated by the FAA; and (2) the Inogen, Inc.'s Inogen One POC, which is currently being evaluated by the FAA. The FAA has reviewed the documentation on both these products and had several discussions with their manufacturers regarding the use of these units on board aircraft. Based on information received to date, the FAA believes that the AirSep POC unit warrants special consideration for use on aircraft. The FAA currently is reviewing the Inogen One POC to determine if it too warrants such special consideration. Therefore, this proposed rule only pertains to the AirSep POC.
The AirSep POC, which does not contain hazardous materials, operates by separating oxygen from nitrogen and other gases comprising ambient air and dispensing it in concentrated form to the user at a purity level of approximately 90% (±3%). The AirSep units deliver five oxygen flow rates of 1 to 5 liters per minute. The AirSep units must have their filters changed by an authorized equipment distributor every 3000 hours. There is an hour meter on the device that notifies the user how many hours have gone by since the last maintenance check. The AirSep units may be operated either from an aircraft electrical outlet (if installed) or by a rechargeable battery with a duration of 50 minutes fully charged.
RSPA has reviewed and evaluated both the AirSep POC and the Inogen POC and determined that these devices are not regulated as hazardous materials in transportation. RSPA issued letters to the manufacturers stating this conclusion in May 2003 (AirSep POC) and March 2004 (Inogen POC).
While the RSPA determination is an important step for the FAA's review of the POCs, the FAA must still make an independent determination whether the devices pose a hazard in aviation. If there is no hazard, then the FAA could grant an exemption to petitioners from either § 121.574, 125.219, or 135.91, as applicable, allowing the use of the POCs because the FAA's regulations apply to devices that dispense oxygen. The FAA informed the portable oxygen community that an exemption would be needed in order for a passenger to carry on and operate a POC not furnished by the aircraft operator via a letter issued through the Department of Transportation's Office of the Secretary in November 2002. To date, the FAA has not yet received any petitions for exemption. The FAA has been informed that several air carriers are interested in this technology and are in the process of evaluating whether these devices interfere with the electrical, navigation or communication equipment on board its aircraft. Rather than waiting for a carrier to apply to the FAA for an exemption under the existing regulatory structure, the FAA has decided to propose an amendment to its regulations to permit passengers to carry on and operate their own POC on board an aircraft as long as certain conditions are met.
Section 1 of the SFAR would indicate that this SFAR prescribes special operating rules for the AirSep POC. It also establishes that the SFAR would apply to both the aircraft operator and the passenger using the POC. Section 2 would then define the AirSep POC.
Section 3 would establish the requirements for operating this device on board an aircraft. Section 3(a)(1) specifies that the aircraft operator is responsible for determining whether the device would interfere with the electrical, navigation or communication equipment aboard each aircraft on which the device is used. The operator is responsible for making this determination pursuant to 14 CFR 91.21, 121.306, 125.204, or 135.144. Given the broad array of aircraft and equipment combinations, only the operator can be responsible for making such a determination.
Section 3(a)(2) would mirror a safety warning contained in the AirSep Patient User Manual. In this Manual, AirSep states that leaving the nasal cannula under bed coverings or chair cushions while the POC is turned on but not in use could result in the oxygen “mak[ing] the material flammable.” However, the FAA has also been informed by AirSep that if the nasal cannula is not positioned to sense inhalation, no oxygen will flow from the cannula. The FAA seeks comments regarding risks associated with the POC being turned on but not in use.
Section 3(a)(3) would require the operator to assure that the user is capable of hearing the unit's various alarms, seeing the alarm light indicators, and taking the appropriate action in response to the alarm, or travel with someone who is capable of performing those functions. This proposed condition also mirrors several warning statements in the AirSep Patient User Manual. The POC is equipped with an alarm that will sound in the event that the unit fails to sense user breathing, overheats, or otherwise malfunctions. Section 3(b)(1) requires that the operator assure that the user turns off the unit in the event that the alarm sounds indicating a general malfunction of the unit while in use on the aircraft.
Section 3(a)(4) would prohibit the operator from allowing smoking or open flame within 10 feet of any person using a POC. The FAA's regulations at § 121.574, 125.219, and 135.91 require no less than 10 feet between a person smoking and a passenger using oxygen. Given the unique environment of an aircraft, and the devastating consequences that can occur in the event oxygen is used too close to someone who is smoking, the FAA is proposing a limit of at least 10 feet. While smoking is no longer allowed on scheduled flights, it may be permitted on non-scheduled flights.
Section 3(a)(5) requires that the operator prevent the air intake/gross particle filter and air outlet from being blocked while in use. The FAA believes it is important to include this statement in its conditions because blocking off the filter or outlet could result in the unit malfunctioning and having to be turned off.
Section 3(a)(6) and (7) would require that the device be stowed either underneath the seat in front of the user, or in another approved stowage location, and that the user is seated, so as not to restrict access to or use of any required emergency, or regular exit or of the aisle in the passenger compartment. These two conditions are consistent with the FAA's existing regulations and are necessary to ensure safe movement within the cabin, prevent injury from loose objects within the cabin and, if necessary, not obstruct evacuation of the aircraft.
Section 3(a)(8) would require the operator to ensure that the device is free from oil, grease or petroleum products. Again this condition is similar to a warning statement contained in the AirSep Patient User Manual and to a condition contained in the FAA's current medical oxygen regulations. This condition also obligates the operator to look at the condition of the device and ensure that it is free from damage and other signs of excessive wear or abuse. Section 3(a)(9) would require the operator to verify that the hour meter indicates that the hours will not exceed 3000 hours by the end of the scheduled flight time of that flight leg. Section 3(a)(10) would require the pilot in command to be notified when a passenger is using the portable oxygen concentrator on board the aircraft. This is consistent with current §§ 121.574, 125.219, and 135.91, and ensures that the pilot in command (PIC) is fully informed.
Section 3(b) would impose certain standards and requirements on the unit's user. Section 3(b)(1) would require the user to be capable of hearing the unit's alarms, seeing the alarm light indicators, and taking the appropriate action in response to the various alarms and alarm light indicators, or be traveling with someone who is capable of hearing the unit's alarms, seeing the alarm light indicators, and taking the appropriate action in response to the various alarms and alarm light indicators.
Section 3(b)(2) would obligate the user to turn off the unit if a warning alarm and associated alarm light indicator detects a general malfunction of the unit. However, FAA has received information from AirSep that a warning
Section 3(b)(3) would mandate that the user must have a statement signed by a licensed physician that specifies the use of the POC and establishes the maximum flow rate corresponding to the pressure in the cabin of the aircraft under normal operating conditions.
Section 3(b)(4) would mirror the AirSep Patient User Manual by requiring that the user only use lotions or salves that are approved for use with oxygen.
Section 3(b)(5) stipulates that the user must ascertain from the aircraft operator the duration of the flight (including any anticipated delays) and provide a sufficient number of batteries to power the device for the duration of the flight, including reasonable delays. This proposal is not intended to require that the AirSep portable oxygen concentrator be powered by batteries as a condition of carriage. Rather, this portion of the NPRM proposes that a user have a sufficient number of batteries to potentially serve as a power source during all phases of flight. This condition is consistent with the means for determining the oxygen quantity needed for the duration of a flight contained in 14 CFR 121.574(a)(5).
The FAA seeks comments on the following questions. First, should the aircraft operator be required to inform the user about the availability of electrical outlets suitable for the AirSep portable oxygen concentrator? Second, should the user be required to carry batteries for the duration of the flight including reasonable delays if there are electrical outlets available on the flight? Third, are the meanings of the terms “anticipated delay” and “reasonable delay” sufficiently clear? In a related Office of the Secretary rulemaking under the Air Carrier Access Act, the Department will seek comment on whether carriers must permit users of AirSep portable oxygen concentrator to plug their devices into available on-board power outlets, consistent with FAA safety rules related to electronic devices.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)), there are no requirements for information collection associated with this proposal.
Changes to Federal regulations must undergo several economic analyses. First, Executive Order 12866 directs that each Federal agency shall propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify its costs. Second, the Regulatory Flexibility Act of 1980 requires agencies to analyze the economic impact of regulatory changes on small entities. Third, the Trade Agreements Act (19 U.S.C. section 2531-2533) prohibits agencies from setting standards that create unnecessary obstacles to the foreign commerce of the United States. In developing U.S. standards, this Trade Act requires agencies to consider international standards and, where appropriate, that they be the basis of U.S. standards. And fourth, the Unfunded Mandates Reform Act of 1995 requires agencies to prepare a written assessment of costs, benefits and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local or tribal governments, in the aggregate, or by the private sector, of $100 million or more, in any one year (adjusted for inflation).
However, for regulations with an expected minimal impact the above-specified regulatory evaluation is not required. The Department of Transportation Order DOT 2100.5 prescribes policies and procedures for simplification, analysis and review of regulations. If it is determined that the expected economic impact is so minimal that the proposal does not warrant a full evaluation, a statement to that effect and the basis for it is included in the proposed regulation.
This proposed SFAR would permit the use of certain portable oxygen concentrator (POC) devices on aircraft, provided certain conditions are satisfied. These conditions are described elsewhere in this document and would impose some costs on aircraft operators who choose to allow FAA approved POCs on board their aircraft. This proposal does not require operators to allow their use, however, and therefore it imposes no costs. The FAA assumes that operators who choose to allow POC use would voluntarily decide to take this action only if it were advantageous for them to do so. Since this proposal imposes no required costs, no economic evaluation was proposed.
The Regulatory Flexibility Act of 1980 (RFA) establishes “as a principle of regulatory issuance that agencies shall endeavor, consistent with the objective of the rule and of applicable statutes, to fit regulatory and informational requirements to the scale of the business, organizations, and governmental jurisdictions subject to the regulation.” To achieve that principle, the Act requires agencies to solicit and consider flexible regulatory proposals and to explain the rationale for their actions. The Act covers a wide range of small entities, including small businesses, not-for-profit organizations and small governmental jurisdictions.
Agencies must perform a review to determine whether a proposed or final rule will have a significant economic impact on a substantial number of small entities. If the determination is that it will, the agency must prepare a regulatory flexibility analysis as described in the Act. However, if an agency determines that a proposed or final rule is not expected to have a significant economic impact on a substantial number of small entities, section 605(b) of the 1980 act provides that the head of the agency may so certify and a regulatory flexibility analysis is not required. The certification must include a statement providing the factual basis for this determination, and the reasoning should be clear.
Since meeting the requirements of this proposed SFAR is entirely voluntary on the part of the aircraft operators, it imposes no economic burden. Consequently, the FAA certifies that the rule would not have a significant economic impact on a substantial number of small entities.
The Trade Agreement Act of 1979 prohibits Federal agencies from engaging in any standards or related activities that create any unnecessary obstacles to the foreign commerce of the United States. Legitimate domestic objectives, such as safety, are not considered unnecessary obstacles. The statute also requires consideration of international standards and where appropriate, that they be the basis for U.S. standards. In addition, consistent with the Administration's belief in the general superiority and desirability of free trade, it is the policy of the Administration to remove or diminish to the extent feasible, barriers to international trade, including both barriers affecting the export of American goods and services to foreign countries
In accordance with the above statute and policy, the FAA has assessed the potential effect of this proposed SFAR to be minimal and therefore has determined that this proposal will not result in an impact on international trade by companies doing business in or with the United States.
The Unfunded Mandates Reform Act of 1995 (the Act) is intended, among other things, to curb the practice of imposing unfunded Federal mandates on State, local, and tribal governments. Title II of the Act requires each Federal agency to prepare a written statement assessing the effects of any Federal mandate in a proposed or final agency rule that may result in an expenditure of $100 million or more (adjusted annually for inflation) in any one year by State, local, and tribal governments, in the aggregate, or by the private sector; such a mandate is deemed to be a “significant regulatory action.” The FAA currently uses an inflation-adjusted value of $120.7 million in lieu of $100 million.
This proposed SFAR does not contain such a mandate. Therefore, the requirements of Title II of the Unfunded Mandates Reform Act of 1995 do not apply.
FAA analyzed this proposed rule under the principles and criteria of Executive Order 13132, Federalism. It determined that this action would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, FAA has concluded that this notice of proposed rulemaking does not have federalism implications.
The energy impact of the proposed rule has been assessed in accordance with the Energy Policy and Conservation Act (EPCA), Public Law 94-163, as amended (42 U.S.C. 6362). FAA has determined that the proposed rule is not a major regulatory action under the provisions of the EPCA.
Air carriers, Aircraft, Airmen, Aviation safety, Charter flights, Safety, Transportation, Air taxis.
In consideration of the foregoing, the Federal Aviation Administration proposes to add SFAR No.____ to Chapter II of Title 14, Code of Federal Regulations, as follows:
1. The authority citation for this SFAR shall read as follows:
49 U.S.C. 106(g), 1153, 40101, 40102, 40103, 40113, 41721, 44105, 44106, 44111, 44701-44717, 44722, 44901, 44903, 44904, 44906, 44912, 44914, 44936, 44938, 46103, 46105.
2. Special Federal Aviation Regulation No. XX is added to read as follows:
(1) The device does not cause interference with the electrical, navigation or communication equipment on the aircraft on which the device is to be used;
(2) The unit must be turned off if the nasal cannula is not positioned for oxygen delivery to the user;
(3) The user must be capable of seeing the alarm indicator lights, hearing the various warning alarms, and taking the appropriate action should the unit fail to detect the user's breathing or a general malfunction occurs, or is traveling with someone who is capable of performing those functions for the user;
(4) No smoking or open flame is permitted within 10 feet of any person using a portable oxygen concentrator;
(5) The air intake/gross particle filter or the air outlet must not be blocked during use;
(6) The unit must either be stowed under the seat in front of the user, or in another approved stowage location, so that it does not block the aisle way or the entryway into the row;
(7) No person using a portable oxygen concentrator is permitted to be seated in an exit row;
(8) The portable oxygen concentrator must be free from oil, grease or other petroleum products and be in good condition free from damage or other signs of excessive wear or abuse;
(9) The number of hours before maintenance must be below 3,000 at the end of the scheduled flight time for that flight leg; and
(10) The pilot in command must be apprised when a passenger is using a portable oxygen concentrator.
(b) The user of the portable oxygen concentrator must comply with the following conditions to use the device on board the aircraft:
(1) The user must be capable of hearing the unit's alarms, seeing the alarm light indicators, and taking the appropriate action in response to the various alarms and alarm light indicators, or be traveling with someone who is capable of performing those functions;
(2) In the event the warning alarm sounds, the portable oxygen concentrator unit must be turned off if the warning alarm and the associated alarm light indicator detects a general malfunction of the unit;
(3) The passenger must have a statement signed by a licensed physician that specifies the use of the portable oxygen concentrator and establishes the maximum flow rate corresponding to the pressure in the cabin of the aircraft under normal operating conditions;
(4) Only lotions or salves that are oxygen approved may be used by persons using the portable oxygen device; and
(5) The user must obtain from the aircraft operator the duration of the planned flight, including any anticipated delays. The user must provide a sufficient number of batteries to power the device for the duration of the flight, including any reasonable delays.