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Animal and Plant Health Inspection Service, USDA.
Interim rule and request for comments.
We are amending the Mexican fruit fly regulations by designating a portion of Willacy County, TX, as a quarantined area and restricting the interstate movement of regulated articles from that area. This action is necessary to prevent the spread of the Mexican fruit fly into noninfested areas of the United States.
This interim rule is effective June 5, 2008. We will consider all comments that we receive on or before August 4, 2008.
You may submit comments by either of the following methods:
•
•
Mr. Wayne D. Burnett, Domestic Coordinator, Fruit Fly Exclusion and Detection Programs, PPQ, APHIS, 4700 River Road Unit 137, Riverdale, MD 20737-1234; (301) 734-4387.
The Mexican fruit fly (
The Mexican fruit fly regulations, contained in 7 CFR 301.64 through 301.64-10 (referred to below as the regulations), were established to prevent the spread of the Mexican fruit fly to noninfested areas of the United States. The regulations impose restrictions on the interstate movement of regulated articles from quarantined areas.
Section 301.64-3 provides that the Deputy Administrator for Plant Protection and Quarantine, Animal and Plant Health Inspection Service (APHIS), shall list as a quarantined area each State, or each portion of a State, in which the Mexican fruit fly has been found by an inspector, in which the Deputy Administrator has reason to believe the Mexican fruit fly is present, or that the Deputy Administrator considers necessary to regulate because of its proximity to the Mexican fruit fly or its inseparability for quarantine enforcement purposes from localities in which the Mexican fruit fly occurs.
Less than an entire State is designated as a quarantined area only if the Deputy Administrator determines that the State has adopted and is enforcing a quarantine or regulation that imposes restrictions on the intrastate movement of the regulated articles that are substantially the same as those that are imposed with respect to the interstate movement of the articles by the APHIS regulations and the designation of less than the entire State as a quarantined area will otherwise be adequate to prevent the artificial interstate spread of the Mexican fruit fly.
Recent trapping surveys by county agencies reveal that a portion of Willacy County, TX, is infested with the Mexican fruit fly.
Accordingly, to prevent the spread of the Mexican fruit fly to noninfested areas of the United States, we are amending the regulations in § 301.64-3 by designating that portion of Willacy County, TX, as a quarantined area for the Mexican fruit fly. The quarantined area is described in detail in the regulatory text at the end of this document. The Deputy Administrator has determined that it is not necessary to designate the entire State of Texas as a quarantined area.
This rulemaking is necessary on an emergency basis to prevent the Mexican fruit fly from spreading to noninfested areas of the United States. Under these circumstances, the Administrator has determined that prior notice and opportunity for public comment are contrary to the public interest and that there is good cause under 5 U.S.C. 553 for making this rule effective less than 30 days after publication in the
We will consider comments we receive during the comment period for this interim rule (see
This rule has been reviewed under Executive Order 12866. For this action, the Office of Management and Budget has waived its review under Executive Order 12866.
This rule amends the Mexican fruit fly regulations by designating a portion of Willacy County, TX, as a quarantined area and restricting the interstate movement of regulated articles from that area. This action is necessary to prevent the spread of the Mexican fruit fly into noninfested areas of the United States.
Within the quarantined area there are approximately 20 small entities that may be affected by this rule. These include two grocery stores, three fruit stands, four citrus producers, six truck vendors, four nurseries, and one recycling center. These 20 entities comprise less than 1 percent of the total number of similar entities operating in the State of Texas. Additionally, these small entities sell regulated articles primarily for local intrastate, not interstate movement, so the effect, if any, of this regulation on these entities appears to be minimal.
The effect on those few entities that do move regulated articles interstate will be minimized by the availability of various treatments that, in most cases, will allow these small entities to move regulated articles interstate with very little additional cost.
Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action will not have a significant economic impact on a substantial number of small entities.
This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 7 CFR part 3015, subpart V.)
This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts all State and local laws and regulations that are inconsistent with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule.
This interim rule contains no new information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Agricultural commodities, Plant diseases and pests, Quarantine, Reporting and recordkeeping requirements, Transportation.
7 U.S.C. 7701-7772 and 7781-7786; 7 CFR 2.22, 2.80, and 371.3.
Section 301.75-15 issued under Sec. 204, Title II, Public Law 106-113, 113 Stat. 1501A-293; sections 301.75-15 and 301.75-16 issued under Sec. 203, Title II, Public Law 106-224, 114 Stat. 400 (7 U.S.C. 1421 note).
(c) * * *
Animal and Plant Health Inspection Service, USDA.
Final rule.
We are amending the regulations to allow noncompetitive entertainment horses from countries affected with contagious equine metritis to be temporarily imported into the United States under certain conditions. The regulations currently provide for the temporary importation of horses from countries affected with contagious equine metritis to compete in specified events. In recent years it has become evident that similar provisions are needed for noncompetitive entertainment horses. This action will allow the temporary importation of horses into the United States solely for public exhibition and entertainment purposes while continuing to protect against the introduction and dissemination of contagious equine metritis.
Dr. Ellen M. Buck, Veterinary Medical Officer, Import/Export Animals, National Center for Import and Export, VS, APHIS, 4700 River Road, Unit 39, Riverdale, MD 20737-1231; (301) 734-8364.
The regulations in 9 CFR part 93 (referred to below as the regulations) prohibit or restrict the importation of certain animals into the United States to prevent the introduction of communicable diseases of livestock and poultry. Subpart C—Horses, §§ 93.300 through 92.326 of the regulations, pertains to the importation of horses into the United States.
Section 93.301 of the regulations contains specific provisions for the quarantine and testing of horses from regions affected with contagious equine metritis (CEM), a highly contagious bacterial venereal disease that affects breeding and fertility. This section also identifies regions where CEM exists and regions that trade horses freely with those where CEM exists without testing for CEM.
To prevent the introduction of CEM into the United States, § 93.301(c)(1) prohibits the importation of horses into the United States from listed regions unless the horses are imported in accordance with certain requirements. To be eligible for importation, the horses must fall into one of the following categories:
• Wild (non-domesticated) species of equidae if captured in the wild or imported from a zoo or other facility where it would be unlikely that the animal would come in contact with domesticated horses used for breeding;
• Geldings;
• Weanlings or yearlings whose age is certified on the import health certificate required under § 93.314(a);
• Horses imported in accordance with conditions prescribed by the Administrator as provided in § 93.301(a);
• Spanish Pure Breed horses imported for permanent entry from Spain or thoroughbred horses imported for permanent entry from France, Germany, Ireland, or the United Kingdom as provided in § 93.301(d);
• Stallions or mares over 731 days of age imported for permanent entry as provided in § 93.301(e);
• Horses over 731 days of age imported into the United States for no more than 90 days to compete in specified events as provided in § 93.301(f); and
• U.S. horses returning to the United States as provided in § 93.301(g).
The Animal and Plant Health Inspection Service (APHIS) has used the provisions in § 93.301(f), relating to the temporary importation of horses for competition, to allow the temporary importation of noncompetitive entertainment horses into the United States. Several performance horse groups have asked APHIS to extend the 90-day limit provided for in § 93.301(f) so that they may exhibit and show their horses in the United States for longer periods of time. In addition, the United States Animal Health Association has recommended that APHIS amend the regulations to establish a category for noncompetitive entertainment horses.
Accordingly, on August 2, 2007, we published in the
We solicited comments concerning our proposal for 60 days ending October 1, 2007. We received four comments by that date. The comments were from a private citizen, State animal health department, horse industry group, and a horse entertainment company. These comments are discussed below.
In the proposed rule we stated that, “[b]ecause CEM is a venereal disease transmitted by sexual contact, there is virtually no risk that a horse will transmit the disease through casual contact with other horses during a performance, exhibition, or exercise.” One commenter stated that APHIS should not lift the CEM restrictions unless there is absolutely no risk of spreading the disease. This commenter suggested that APHIS reconsider the proposed rule and tighten the CEM restrictions instead.
We disagree. As discussed in the proposed rule, APHIS has conducted a risk assessment to evaluate the risk of allowing the extended importation of noncompetitive entertainment horses from countries affected with CEM without requiring CEM testing, and the risk of the U.S. Department of Agriculture (USDA) losing track of these horses during extended importation. The risk assessment, titled “Assessment of the Risk of Introduction of Contagious Equine Metritis (CEM) through the Extended Importation of Noncompetitive Entertainment Horses from CEM-affected countries,” concluded that the risk posed by allowing the extended importation of noncompetitive entertainment horses from CEM-affected countries would be extremely low, with the application of the restrictions described in the rule. In addition, the risk assessment concluded that the risk of USDA losing track of the animals was extremely low due to the extensive supervision and involvement of APHIS personnel and the accredited veterinarian. The risk assessment is supported by our experiences with the importation of horses to compete in specified events under conditions very similar to those proposed for noncompetitive entertainment horses. Accordingly, we are making no changes based on this comment.
Another commenter stated that the regulations should protect the health of U.S. horses from imported horses regardless of the reason for their importation. Therefore, the commenter recommended that the health certificate and testing requirements set forth in proposed § 93.301(f)(3) for noncompetitive entertainment horses also be required for horses temporarily imported for competition.
In the proposed rule, we proposed to amend the regulations to require that, at the time of importation, each horse imported for competition or public exhibition and entertainment purposes be accompanied by an import permit in accordance with § 93.304 and a health certificate in accordance with § 93.314. However, for noncompetitive entertainment horses, we also proposed to require that the health certificate certify that cultures negative for CEM have been collected on three separate occasions within a 7-day period, with the last within 30 days of exportation. We proposed more stringent CEM testing requirements for noncompetitive entertainment horses because these horses could be imported for long periods of time, compared to horses imported for competition. Currently, § 93.301(f) provides that horses may be imported for competition for no more than 90 days under certain conditions. The requirement for CEM testing prior to importation for noncompetitive entertainment horses will help to ensure that horses infected with CEM do not enter this country and jeopardize the health of the U.S. horse population. For these reasons, we are making no change in response to this comment.
The commenter also requested that APHIS clarify that the average salary used in the trust fund/costs is the salary for APHIS personnel. Proposed § 93.301(f)(10) provides that the costs associated with the supervision and maintenance of the horse by an APHIS representative be reimbursed by the horse's owner or importer through user fees payable under 9 CFR part 130, which lists the hourly rate and minimum user fee for certain import-related services provided by APHIS. Proposed § 93.301(f)(11) set out the requirements for trust fund agreements. More specifically, that paragraph provided that the horse's owner or importer deposit with APHIS an amount equal to the estimated cost, as determined by APHIS, for the APHIS representative to inspect the premises at which the horse will compete, perform, or be exhibited and to conduct the monitoring and supervision required by the regulations. We do not believe that additional clarification is needed. We are making no change based on this comment.
One commenter supported the proposed rule but was concerned that USDA may not be able to provide the monitoring required by the regulations over extended periods of time.
APHIS is committed to providing the services specified in the proposed rule and this final rule to prevent the introduction of CEM into the United States by noncompetitive entertainment horses. As discussed in the proposed rule, we would require noncompetitive
A commenter stated that proposed § 93.301(f)(5)(iv)(B), which provides that horses must be kept on a premises that is or contains a building, is too restrictive. The commenter noted that entertainment horse shows often use stable installations, such as tents, that may be set up and taken down in each city. Thus, the commenter recommended that the regulations be amended to define the term “building” to include tent structures.
We agree that the regulations should be flexible enough to cover buildings as well as tent stables or other temporary structures for housing horses. Therefore, in this final rule, we are amending § 93.301(f)(5)(iv)(B) to provide that the horse must be kept on a premises that is or contains a building or temporary structure in which the horse can be kept in a stall that is separated from other stalls that contain horses that are not listed on the import permit, either by an empty stall, by an open area across which horses cannot touch each other, or by a solid wall that is at least 8 feet (2.4 meters) high. The horse may be kept only on premises that have been approved by an APHIS representative.
The commenter also recommended amending § 93.301(f)(5)(iv)(B) to allow APHIS to approve isolation measures other than those set out in that paragraph. Specifically, the commenter recommended revising that paragraph to read as follows: “Must be or contain a building in which the horse can be kept in a stall that is separated from other stalls that contain horses that are not listed on the import permit, either by an empty stall, by an open area across from which horses cannot touch each other, by a solid wall that is at least 8 feet (2.4 meters) high, or by such other means deemed appropriate by APHIS in the circumstances.”
As noted in the proposed rule, one of the primary safeguards against the horses transmitting CEM while in the United States is the stringent measures in the regulations to ensure that the horses are kept apart from horses that are not listed on the import permit. This final rule provides several means by which the necessary isolation from horses that are not listed on the import permit could be accomplished. We do not believe that additional flexibility is needed. Accordingly, we are making no change in response to this comment.
The same commenter recommended that proposed § 93.301(f)(6) be amended to allow last-minute changes to the itinerary in an emergency. Section 93.301(f)(6) provides that, if an owner or importer wishes to change the horse's itinerary or the methods by which the horse is transported from those specified on the import permit, the owner or importer must make the request for change in writing to the Administrator at least 15 days before the proposed date of change. The commenter noted that touring inevitably entails unforeseen changes of plans, venues, dates, etc.
We agree that the regulations should allow for changes to the itinerary or methods of transportation in an emergency. In this final rule, we are adding a new paragraph to provide that the horse's itinerary or methods of transportation may be changed, with the prior approval of an APHIS representative, in order to respond to an emergency or other unforeseen circumstances or events (e.g., weather-related transportation delays, vehicle breakdown, medical emergencies, etc.). Requests for such a change may be submitted to APHIS by telephone, postal mail, commercial delivery service, fax, or e-mail. We may approve the request for change orally or in writing. If the approval is oral, it will be confirmed in writing by the Administrator as soon as possible. These changes will provide greater flexibility for a horse's owner or importer to respond to emergencies or other unforeseen circumstances or events.
In this final rule, we are also amending paragraph (f)(6) to make it clear that written requests for change may be submitted via postal mail, commercial delivery service, fax, or e-mail. APHIS has always allowed such written requests for change; however, we are adding that provision to the regulations to make it clear to the public.
The commenter also recommended that APHIS amend proposed § 93.301(f)(8) to provide the Administrator the discretion to allow horses to perform pending resolution of an appeal of the cancellation of an import permit, provided that such performances would not pose a risk to U.S. horses and the owner or importer could demonstrate material harm from the interruption of performances.
Proposed § 93.301(f)(7) provides that the Administrator may cancel an import permit whenever the Administrator finds that the owner or importer of the horse has not complied with certain provisions in the regulations or any conditions imposed under those provisions. Proposed § 93.301(f)(8) provides that the horse is not permitted to enter competition, perform, or be exhibited from the date the owner or importer receives the notice of cancellation until the horse is moved out of the United States or until resolution of an appeal in favor of the owner or importer. The potential cancellation of an import permit for noncompliance with the regulations provides an incentive for a horse owner or importer to remain in compliance with the regulations; allowing the horse to continue to perform or be exhibited pending the resolution of an appeal would be counterproductive. Accordingly, we are making no change based on this comment.
Finally, the commenter recommended that proposed § 93.304(a)(1)(iii)(D) through (H), relating to the proposed length of stay and itinerary, be amended to allow the applicant for an import permit to provide some of this information to APHIS at the time of application and the rest at intervals to be set by APHIS and the applicant.
In the proposed rule, we listed the information that must be supplied to APHIS by the owner or importer with the application for an import permit. We noted that the specified information would allow APHIS to monitor the location of the horse while it is in the United States and to confirm compliance with the required isolation and handling procedures to ensure that the horse does not transmit CEM to any other horse while in this country. Given the potential for long stays in the United States for noncompetitive entertainment horses and our need for current information to monitor compliance with the regulations, we also proposed to require that, while in the United States, the owner or importer apply for and obtain from APHIS an import permit each year prior to the anniversary date of the horse's arrival in the United States. To accommodate changes to the itinerary following importation, in proposed § 93.301(f)(6), we also established provisions by which a horse owner or importer could request APHIS approval of a change to the horse's itinerary or the methods of transportation from those specified in the application for an import permit. We believe these provisions, in combination, provide the flexibility that the commenter is seeking. Accordingly, we are making no change in response to this comment.
Therefore, for the reasons given in the proposed rule and in this document, we
This final rule has been reviewed under Executive Order 12866. The rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.
We are amending the regulations to establish conditions under which noncompetitive entertainment horses (stallions and mares) over 731 days of age from CEM-affected countries could remain in the United States for longer than 90 days for public exhibition and entertainment purposes without undergoing the CEM quarantine and testing prescribed in the regulations.
The horse industry plays an important role in the U.S. economy. According to the 2002 Census of Agriculture, there were 542,223 farms with 3.644 million horses valued at $9.9 billion in the United States in 2002. According to a recent study done for the American Horse Council, the number and value of horses are much larger than those reported in the 2002 Census of Agriculture: 2 million people owning 9.2 million horses with direct value of about $39 billion.
The United States imported a total of 31,198 horses in 2005. Nearly 67 percent of horses imported were from Canada and 7.6 percent were from Mexico. Of the total imports, 25,564 were from non-CEM countries and the remaining 5,634 were from CEM countries. The proportion of horse imports that are pure breeding horses is small. Of the above total, 2,341 were purebred breeding horses. Only 340 purebred breeding horses were imported from CEM countries.
Although the disease does not result in death, CEM can be economically costly. The direct consequence may include the closing of breeding operations, production losses as a result of abortion, and costs of disease control. A CEM outbreak would result in the quarantine of affected horse farms, temporary cessation of breeding operations, and restriction of both intrastate and interstate movement. For some breeders, this could mean the loss of thousands or even millions of dollars in stud fees and breeding losses. Other consequences include trade restrictions that may be imposed by international trading partners.
The noncompetitive entertainment horses that will be affected by this rule will not be allowed to have direct contact with horses outside those listed on their permit and may not be used for breeding purposes at any time while in the United States, including breeding with horses in the same show. Additionally, these horses may not undergo any genital examinations (unless required for diagnosis and treatment of a medical condition with prior approval of an APHIS representative), semen collection, or artificial insemination. Furthermore, since these are very specialized performance animals, domestic breeders will not be affected if this rule were to increase the amount of time the imported horses are in the United States.
Horses arriving in the United States from abroad are quarantined at a USDA animal import center, generally for 3 days. Horses temporarily imported are required to exit the United States and be readmitted, following quarantine and testing, every 90 days. Each entry after 90 days is considered a new entry into the United States. The USDA charges a minimum of $810 for the 3-day quarantine. In addition to this facility charge, user fees of $80 are charged for blood testing, resulting in a total quarantine and testing cost per horse of $890. The final rule will allow imported performance horses to stay in the United States longer than 90 days without their owners having again to pay USDA import quarantine and testing costs. This is a savings that accrues to the importing entities and likely to counterbalance their costs associated with supervisory activities of APHIS and/or an accredited veterinarian.
The number of entities and horses expected to be directly affected by this rule is not large. We anticipate that between 1 and 10 performing groups varying in size from 5 to 40 horses (or a total of between 5 and 400 horses) will utilize the proposed exception each year. Given that there are over 1 million domestic show horses, even the upper quantity represents a very small fraction of the total supply (0.04 percent).
The Small Business Administration (SBA) has established guidelines for determining which types of firms are to be considered small entities under the Regulatory Flexibility Act. This rule may affect operations such as zoological parks (North American Industry Classification System [NAICS] code 712130), and animal performances including circuses, carnivals, and amusement parks (NAICS code 711190). SBA classifies these operations as small entities if their annual receipts are not more than $6.5 million. Of the approximately 850 such establishments, about 12.5 percent are considered to be large. The subset of these entities that temporarily import noncompetitive entertainment horses from CEM countries will benefit from the forgone costs associated with the horses having to exit and reenter the United States every 90 days. On the other hand, they will bear the cost of supervisory activities by APHIS and/or an accredited veterinarian. The overall impact is expected to be insignificant, given the relatively small number of noncompetitive entertainment horses imported from CEM countries.
Other operations that may remotely be affected are domestic suppliers of similar horses (NAICS code 112920). According to the 2002 Census of Agriculture, that year there were 542,223 horse farms with 3,644,278 horses in the United States, of which 124,596 farms sold 470,423 horses that had a total value of over $1.13 billion.
Entities that may be affected by the rule are principally small businesses, but the impact of the rule is not expected to be significant. Because the pool of noncompetitive entertainment horses that are temporarily imported is a small fraction of the total number of show horses in the United States, any effects of the rule on U.S. entities will be very small.
Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action will not have a significant economic impact on a substantial number of small entities.
This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 7 CFR part 3015, subpart V.)
This 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 the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The Animal and Plant Health Inspection Service is committed to compliance with the E-Government Act to promote the use of the Internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. For information pertinent to E-Government Act compliance related to this rule, please contact Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 851-2908.
Animal diseases, Imports, Livestock, Poultry and poultry products, Quarantine, Reporting and recordkeeping requirements.
7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.
(c)
* * *
(2) * * *
(viii) Horses over 731 days of age imported into the United States for noncompetitive public exhibition and entertainment purposes if the horses meet the requirements of paragraph (f)(2) of this section; and
(f)
(1) Horses over 731 days of age may be imported into the United States for no more than 90 days to compete in specified events provided that the conditions in paragraphs (f)(3) through (f)(12) of this section are met.
(2) Horses over 731 days of age may be temporarily imported into the United States solely for noncompetitive public exhibition and entertainment purposes provided that the conditions in paragraphs (f)(3) through (f)(12) of this section are met.
(3) At the time of importation, each horse must be accompanied by an import permit in accordance with § 93.304 and a health certificate issued in accordance with § 93.314. For horses imported in accordance with paragraph (f)(2) of this section, the health certificate must also certify that cultures negative for CEM were obtained from sets of specimens collected on three separate occasions within a 7-day period from the mucosal surfaces of the clitoral fossa and the clitoral sinuses of any female horses and from the surfaces of the prepuce, the urethral sinus, and the fossa glandis, including the diverticulum of the fossa glandis, of any male horses. For both female and male horses, the sets of specimens must be collected on days 1, 4, and 7 of the 7-day period, and the last of these sets of specimens must be collected within 30 days of exportation. All specimens required by this paragraph must be collected by a licensed veterinarian who either is, or is acting in the presence of, the veterinarian signing the certificate.
(4) Following the horse's arrival in the United States:
(i) A horse imported in accordance with paragraph (f)(1) of this section may remain in the United States for not more than 90 days, except as provided in paragraph (f)(9) of this section.
(ii) A horse imported in accordance with paragraph (f)(2) of this section may remain in the United States indefinitely, except as provided in paragraph (f)(9) of this section, as long as the conditions of paragraphs (f)(3) through (f)(12) of this section are met and the horse's owner or importer applies for and obtains from APHIS an import permit, as provided for in § 93.304, each year prior to the anniversary date of the horse's arrival in the United States.
(5) While the horse is in the United States, the following conditions must be met:
(i) A horse imported in accordance with paragraph (f)(2) of this section:
(A) Must not be entered in competitions.
(B) Must be regularly used in performances or exhibitions, unless sick or injured. A horse that is no longer performing or being exhibited must be exported or made eligible for permanent entry in accordance with paragraph (f)(9) of this section.
(C) Must be kept with the other horses listed on the import permit, unless otherwise approved by an APHIS representative.
(ii) Except as provided in paragraph (f)(5)(viii) of this section, the horse must be moved according to the itinerary and methods of transport specified in the import permit provided for in § 93.304.
(iii) The horse must be monitored by an accredited veterinarian or APHIS representative to ensure that the provisions of paragraphs (f)(5)(ii), (f)(5)(vi), and (f)(5)(vii) of this section are met. If the monitoring is performed by an accredited veterinarian, the Veterinarian in Charge will ensure that the accredited veterinarian is familiar with the requirements of this section and spot checks will be conducted by an APHIS representative to ensure that the requirements of this section are being met. If an APHIS representative finds that requirements are not being met, the Administrator may require that all remaining monitoring be conducted by APHIS representatives to ensure compliance.
(iv) Except when in transit, the horse must be kept on a premises that has been approved by an APHIS representative. For horses imported in accordance with paragraph (f)(1) of this section, such approval may be oral or in writing. If the approval is oral, it will be confirmed in writing by the Administrator as soon as circumstances permit. For horses imported in accordance with paragraph (f)(2) of this section, the approval will be in writing. To receive approval, the premises:
(A) Must not be a breeding premises; and
(B) Must be or contain a building or temporary structure in which the horse can be kept in a stall that is separated from other stalls that contain horses that are not listed on the import permit, either by an empty stall, by an open area across which horses cannot touch each other, or by a solid wall that is at least 8 feet (2.4 meters) high.
(v) While in transit, the horse must be moved in either an aircraft or a sealed van or trailer. If the horse is moved in a sealed van or trailer, the seal may be broken only by an APHIS representative at the horse's destination, except in situations where the horse's life is in danger.
(vi) Except when actually competing, performing, or being exhibited or exercised, the horse must be kept in a pasture approved by APHIS or in a stall that is separated from other stalls containing horses that are not listed on the import permit, either by an empty stall, by an open area across which horses cannot touch each other, or by a solid wall that is at least 8 feet (2.4 meters) high.
(vii) The horse may not be used for breeding purposes (including artificial insemination or semen collection) and may not have any other sexual contact with other horses. The horse may not undergo any genital examinations, except that a horse imported in accordance with paragraph (f)(2) of this section may undergo genital examinations for diagnosis or treatment of a medical condition with the prior approval of an APHIS representative.
(viii) The horse may be moved for diagnosis or treatment of a medical condition with the prior approval of an APHIS representative.
(ix) After the horse is transported anywhere in the United States, any vehicle in which the horse was transported must be cleaned and disinfected in the presence of an APHIS representative, according to the procedures specified in §§ 71.7 through 71.12 of this chapter, before any other horse is transported in the vehicle.
(x) The cleaning and disinfection specified in paragraph (f)(5)(ix) of this section must be completed before the vehicle is moved from the place where the horse is unloaded. In those cases where the facilities or equipment for cleaning and disinfection are inadequate at the place where the horse is unloaded, the Administrator may allow the vehicle to be moved to another location for cleaning and disinfection when the move will not pose a disease risk to other horses in the United States.
(xi) The owner or importer of the horse must comply with any other provisions of this part applicable to him or her.
(6) Except as provided in paragraph (f)(7) of this section, if the owner or importer wishes to change the horse's itinerary or the methods by which the horse is transported from that which he or she specified in the application for the import permit, the owner or importer must make the request for change in writing to the Administrator. Requests for change must be submitted to APHIS no less than 15 days before the proposed date of the change. Requests may be submitted to APHIS by postal mail, commercial delivery service, fax, or e-mail. The change in itinerary or method of transport may not be made without the written approval of the Administrator, who may grant the request for change when he or she determines that granting the request will not endanger other horses in the United States and that sufficient APHIS personnel are available to provide the services required by the owner or importer.
(7) In response to an emergency or other unforeseen circumstances or events (e.g., weather-related transportation delays, vehicle breakdown, medical emergencies, etc.), the horse's itinerary or methods of transportation may be changed, with the prior approval of an APHIS representative, from that which is specified in the application for an import permit. Requests for such a change may be submitted to APHIS by telephone, postal mail, commercial delivery service, fax, or e-mail. Approval may be oral or in writing. If the approval is oral, it will be confirmed in writing by the Administrator as soon as circumstances permit.
(8) The Administrator may cancel, orally or in writing, the import permit provided for under § 93.304 whenever the Administrator finds that the owner or importer of the horse has not complied with the provisions of paragraphs (f)(3) through (f)(7) of this section or any conditions imposed under those provisions. If the cancellation is oral, the Administrator will confirm the cancellation and the reasons for the cancellation in writing as soon as circumstances permit. Any person whose import permit is canceled may appeal the decision in writing to the Administrator within 10 days after receiving oral or written notification of the cancellation, whichever is earlier. If the appeal is sent by mail, it must be postmarked within 10 days after the owner or importer receives oral or written notification of the cancellation, whichever is earlier. The appeal must include all of the facts and reasons upon which the person relies to show that the import permit was wrongfully canceled. The Administrator will grant or deny the appeal in writing as promptly as circumstances permit, stating the reason for his or her decision. If there is a conflict as to any material fact, a hearing will be held to resolve the conflict. Rules of practice concerning the hearing will be adopted by the Administrator.
(9) Except in those cases where an appeal is in process, any person whose import permit is canceled must move the horse identified in the import permit out of the United States within 10 days after receiving oral or written notification of cancellation, whichever is earlier. The horse is not permitted to enter competition, perform, or be exhibited from the date the owner or importer receives the notice of cancellation until the horse is moved out of the United States or until resolution of an appeal in favor of the owner or importer. Except when being exercised, the horse must be kept, at the expense of the owner or importer, in a stall on the premises where the horse is located when the notice of cancellation is received or, if the horse is in transit when the notice of cancellation is
(10) Stallions or mares over 731 days of age that are imported in accordance with paragraphs (f)(1) or (f)(2) of this section may be eligible to remain in the United States if the following is completed:
(i) Following completion of the itinerary specified in the import permit provided for in § 93.304, the horse's owner or importer applies for and receives a new import permit that specifies that the stallion or mare will be moved to an approved State listed in paragraph (h)(6) or (h)(7) of this section; and
(ii) The stallion or mare is transported in a sealed vehicle that has been cleaned and disinfected to an approved facility in an approved State where it is quarantined under State or Federal supervision until the stallion or mare has met the testing and treatment requirements of paragraph (e)(3) or (e)(5) of this section.
(11) All costs and charges associated with the supervision and maintenance of a horse imported under paragraphs (f)(1) or (f)(2) of this section will be borne by the horse's owner or importer. The costs associated with the supervision and maintenance of the horse by an APHIS representative at his or her usual places of duty will be reimbursed by the horse's owner or importer through user fees payable under part 130 of this chapter.
(12) In the event that an APHIS representative must be temporarily detailed from his or her usual place of duty in connection with the supervision and maintenance of a horse imported under this paragraph (f), the owner or importer of the horse must execute a trust fund agreement with APHIS to reimburse all expenses (including travel costs, salary, per diem or subsistence, administrative expenses, and incidental expenses) incurred by the Department in connection with the temporary detail. Under the trust fund agreement, the horse's owner or importer must deposit with APHIS an amount equal to the estimated cost, as determined by APHIS, for the APHIS representative to inspect the premises at which the horse will compete, perform, or be exhibited; to conduct the monitoring required by paragraph (f)(5)(iii) of this section; and to supervise the cleaning and disinfection required by paragraph (f)(5)(ix) of this section. The estimated costs will be based on the following factors:
(i) Number of hours needed for an APHIS representative to conduct the required inspection and monitoring;
(ii) For services provided during regular business hours (8 a.m. to 4:30 p.m., Monday through Saturday, except holidays), the average salary, per hour, for an APHIS representative;
(iii) For services provided outside regular business hours, the applicable rate for overtime, night differential, or Sunday or holiday pay, based on the average salary, per hour, for an APHIS representative;
(iv) Number of miles from the premises at which the horse competes, performs, or is exhibited to the APHIS office or facility that is monitoring the activities;
(v) Government rate per mile for automobile travel or, if appropriate, cost of other means of transportation between the premises at which the horse competes, performs, or is exhibited and the APHIS office or facility;
(vi) Number of trips between the premises at which the horse competes, performs, or is exhibited and the APHIS office or facility that APHIS representatives are required to make in order to conduct the required inspection and monitoring;
(vii) Number of days the APHIS representative conducting the inspection and monitoring must be in “travel status”;
(viii) Applicable Government per diem rate; and
(ix) Cost of related administrative support services.
(13) If a trust fund agreement with APHIS has been executed by the owner or importer of a horse in accordance with paragraph (f)(12) of this section and APHIS determines, during the horse's stay in the United States, that the amount deposited will be insufficient to cover the services APHIS is scheduled to provide during the remainder of the horse's stay, APHIS will issue to the horse's owner or importer a bill to restore the deposited amount to a level sufficient to cover the estimated cost to APHIS for the remainder of the horse's stay in the United States. The horse's owner or importer must pay the amount billed within 14 days after receiving the bill. If the bill is not paid within 14 days after its receipt, APHIS will cease to perform the services provided for in paragraph (f)(5) of this section until the bill is paid. The Administrator will inform the owner or importer of the cessation of services orally or in writing. If the notice of cessation is oral, the Administrator will confirm, in writing, the notice of cessation and the reason for the cessation of services as soon as circumstances permit. In such a case, the horse must be kept, at the expense of the owner or importer and until the bill is paid, in a stall either on the premises at which the horse is located when the notice of cessation of services is received or, if the horse is in transit when the notice of cessation of services is received, on the premises at which it is next scheduled to compete, perform, or be exhibited according to the import permit. The stall in which the horse is kept must be separated from other stalls containing horses that are not listed on the import permit, either by an empty stall, by an open area across which horses cannot touch each other, or by a solid wall that is at least 8 feet (2.4 meters) high. In cases where the owners of the premises where the horse would be kept following a cessation of services do not permit the horse to be kept on those premises, or when the Administrator determines that keeping the horse on the premises will pose a disease risk to other horses in the United States, the horse must be kept, at the expense of the owner or importer, on an alternative premises approved by the Administrator. Until the bill is paid, the horse is not permitted to enter competition, perform, or be exhibited. Any amount deposited in excess of the costs to APHIS to provide the required services will be refunded to the horse's owner or importer.
(Approved by the Office of Management and Budget under control numbers 0579-0040, 0579-0165, and 0579-0324).
(a)
(iii) Horses intended for importation under § 93.301(f)(2) must meet the permit requirements of paragraph (a)(1)(i) of this section. Additionally, for horses intended for importation under § 93.301(f)(2), the horse's owner or importer must include the following information with the application for permit that is required by paragraph (a)(1)(i) of this section:
(A) The individual identifying information required in paragraph (a)(1)(i) of this section for all horses to be imported.
(B) The permanent electronic identification of each horse to be imported, if applicable. In the event that a horse has permanent electronic identification, the horse must be accompanied by a compatible reader.
(C) Photographs (head and lateral views) that are sufficient to identify each horse on an electronic medium approved by APHIS.
(D) The proposed total length of stay in the United States.
(E) A description of the shows or events in which the horse will perform while in the United States.
(F) The names, dates, and locations of the venues in which the horse will perform while in the United States.
(G) The names and locations of the premises on which the horse will be kept while in the United States, and the dates the horse will be kept on each premises.
(H) The methods and routes by which the horse will be transported while in the United States.
(I) A written plan for handling sick or injured horses that includes:
(
(
(
(J) An application for a trust fund or escrow account agreement with APHIS in accordance with § 93.301(f)(12).
(Approved by the Office of Management and Budget under control numbers 0579-0040 and 0579-0324).
Farm Credit Administration.
Final rule.
The Farm Credit Administration (FCA, Agency, or we) adopts a final rule that amends capital regulations governing the Federal Agricultural Mortgage Corporation (Farmer Mac or the Corporation). The final rule updates the Risk-Based Capital Stress Test (RBCST, RBC model, model) in response to recent changes in Farmer Mac's operations that are not addressed in the current version (Version 2.0). The final rule also amends the current model's assumption regarding the carrying costs of nonperforming loans to better reflect Farmer Mac's actual business practices. In addition, the final rule adds a new component to the model to recognize counterparty risk on nonprogram investments through application of discounts or “haircuts” to the yields of those investments and makes technical amendments to the layout of the model's Credit Loss Module. The effect of the rule is to update the model so that it continues to appropriately reflect risk in a manner consistent with statutory requirements for calculating Farmer Mac's regulatory minimum capital level under a risk-based capital stress test.
or
Under section 8.32 of the Farm Credit Act of 1971, as amended,
The final rule (Version 3.0 of the RBC model) is adopted with one revision from the proposed rule. The revision permits the Director of the Office of Secondary Market Oversight to reduce the haircut level applied to unrated investments.
Our analysis of the RBCST has identified a need to update the model in response to changing financial markets, new business practices and the evolution of the loan portfolio at Farmer Mac, as well as continuing development of industry best practices among leading financial institutions. Our goal is to ensure that the RBCST reflects changes in the Corporation's business structure and loan portfolio that have occurred
We received one comment letter on the proposed rule from Farmer Mac. In general, Farmer Mac agreed with FCA's objective to revise the RBCST to reflect Farmer Mac's actual business risks more accurately but offered specific comments on three aspects of the proposed rule—the method of calculating the loan loss resolution time factor (LLRT), funding rate assumptions applied to nonperforming loan volume, and the treatment of unrated Government-sponsored enterprises (GSE) for purposes of applying discounts (or “haircuts”) to nonprogram investments.
Below is a description of the three specific comments on the proposed rule and FCA's responses to the comments.
The proposed rule's method for calculating the LLRT called for first calculating the average LLRT of nonperforming loans for all such loans that have resolved by the calculation date.
In developing the proposed approach, we considered several issues related to the application of duration or survival models, including the uniformity of the “arrivals” into default, the possible impact of UPB at time of default on remaining resolution experience, and general sample characteristics including length of observation window, fraction censored, and average life relative to observation window. The proposed approach was intended to balance the demands of a more complex modeling approach with the limits of the data set over the relatively short window (roughly 11 years), the relatively small set of loans in default and the observed high relative rate of default in a period centered near 2002 that substantially departs from a uniform arrival pattern. Farmer Mac correctly implies that excluding loans with relatively short durations in default as of the calculation date avoids a downward influence on the calculated LLRT. However, the treatment of unresolved nonperforming loans that have individual LLRTs greater than the average of those that have resolved as of the calculation date carries the opposite effect (i.e., avoids an upward influence) relative to their eventual resolution experience, because the current life at the calculation date is used in the weighted average calculation rather than its yet-to-be-determined actual life. The current life of this subset of loans at the calculation date necessarily understates their eventual LLRT and, thus, exerts an offsetting influence on the excluded subset. While there is not a formal statistical test for the relative impact of these two effects (treatment of both longer-than- and shorter-than-average LLRT), the adopted approach is intended to balance the two offsetting influences.
Farmer Mac suggested consideration of a more formal method to accommodate censored data in a duration or life-survival type model, and we conducted several related analyses. Importantly, the bulk of the defaults occurred in a period of time relatively early in the observation window. While the rate of arrival into default is non-uniform, the censored distribution displays the statistically useful property of increasing smoothly toward the censoring date. We calculated several measures of mean time in default on both UPB-weighted and unweighted bases, with alternative treatments of the unresolved data. Under all subsets of data examined, the UPB-weighted LLRT values are consistently 15 to 20 percent larger than the unweighted LLRT estimates.
We also estimated alternative specifications of the related hazard and survival functions using data supplied by Farmer Mac on all loans that had entered default status as of October 1, 2007, under (i) standard direct life tables with censored data, (ii) Kaplan-Meier methods, and (iii) Cox censored regression methods. The Kaplan-Meier method provides a direct method for recovery of the mean survival time accommodating the influence of the censored data at 1.79 years on an unweighted UPB basis. This value can be contrasted with a value of 1.60 on an unweighted basis using the method in the proposed rule for the same data set. Including the influence of UPB-weighting results in the proposed rule's method increasing from 1.6 to 1.88, a value below that which we expect to find from any form of a censored regression or Lifetest model after weighting by UPB. Importantly, the survival function models we estimated generally confirm the significance of UPB on time-in-default and further argue for the use of UPB-weighted LLRT. Our testing of the suggested general approaches has shown that the joint treatment of excluded loans with lower than average current LLRTs and the conservative treatment of loans with longer than average but currently unresolved LLRTs results in a similar but slightly lower LLRT value compared with the censored regression methods suggested by Farmer Mac.
We conclude that the simplicity of the proposed approach is warranted because of the similarity in estimated values and the fact that Farmer Mac would have to re-run this test every quarter to update the LLRT. We note that, as the observation window continues to lengthen and the influence of censored loan data continues to decline, the specific treatment employed becomes less important because we expect the censored data effects to become more diluted.
Farmer Mac commented that the proposed funding rates applied to nonperforming loan volume do not reflect its actual operations and reiterated the comments in its letter of April 17, 2006, which related to the proposed rule for Version 2.0 of the RBC
The Agency acknowledged in the proposed rule that, under unusual conditions, the short-term rate may not be the minimum rate, and Farmer Mac could potentially reallocate to some degree debt on its books in order to fund nonperforming loans at a point on its corporate yield curve that might be more advantageous than the short-term rate. Such a reallocation could necessitate a corresponding reallocation of funding to a different asset to offset the debt associated with the now-optimally funded nonperforming loan position. We did not attempt to reflect forward discretionary management behavior or develop an “optimal” funding practice that would result in effective funding durations changing throughout the modeled 10-year period of the RBCST. In the proposed rule, we discussed this possibility and rejected a more complex LLRT funding assumption in favor of the proposed approach, particularly in light of the fact that the model is cast with only two maturity groupings (“buckets”) of debt securities. To do otherwise would require adding substantial complexity to the components of the model reflecting funding costs—components which we believe are reasonably well calibrated to actual operations of Farmer Mac in their current aggregated form (i.e., two duration buckets).
We believe the proposed approach reflects Farmer Mac's typical practices under normal conditions, and Farmer Mac has confirmed this is true in the preponderance of cases. To attempt to build an “optimal” or “discretionary” future duration-of-funding model that depends on the projected forward balance sheet composition in the model is beyond the scope of the model.
Farmer Mac commented that the proposed method of applying haircuts to unrated GSE securities should be changed. Specifically, Farmer Mac believes the model should treat such securities as AAA-rated, rather than limiting such treatment only to GSE securities that are fully guaranteed by a GSE. Farmer Mac asserts that this approach would both reflect the low risk of default on all GSE securities and be consistent with FCA's approach to risk-weighting similar assets on the balance sheets of other Farm Credit System (System) institutions.
We disagree with Farmer Mac's assertion that the risk-based capital framework for other System institutions provides support for a policy that would apply AAA haircuts to all GSE securities regardless of their rating. The risk-based capital framework for other System institutions is fundamentally different from the RBCST applied to Farmer Mac as required by section 8.32 of the Farm Credit Act. The purpose of the regulations governing System capital requirements is to protect a System institution against unexpected losses arising from all types of risk, unlike this component of the RBC model, the purpose of which is to estimate counterparty risk. Comparing the proposed haircuts with capital requirements is not a relevant comparison because equity requirements to cover all types of unexpected losses applied as a percentage of volume are not comparable to haircuts to reflect counterparty risk that are applied by reducing estimated future cashflows over the RBC model's 10-year time horizon on a gradually increasing basis. Accordingly, GSE investments with ratings will be haircut in accordance with the schedule in this rule.
In Version 3.0, we have revised the loan seasoning codes previously used in the Credit Loss Module to make off-balance sheet loan seasoning codes the same as those used for on-balance sheet loans and made other conforming data entry changes in the RBCST module. We have also incorporated a specification for senior subordinated loans in the Credit Loss Module to reduce the loss impact by the degree of subordination as referenced in the proposed rule.
Our tests indicate that changes related to the LLRT would have the most significant impact on risk-based capital calculated by the model. The table below provides an indication of the relative impact of each revision for the quarter ended December 31, 2007, using preliminary model submission information for the fourth quarter 2007. The lines labeled “Impact of Carrying Costs of Nonperforming Loans within Ver. 3.0 (estimated),” “Impact of Investment Haircuts within Ver. 3.0 (estimated),” and “Impact of Treatment of Off-Balance Sheet AgVantage Program Volume and Other Credit-Enhanced Program Volume (e.g., Subordinated Interests) within Ver. 3.0 (estimated)” present the minimum risk-based capital level calculated if that revision were excluded from the final
Pursuant to section 605(b) of the Regulatory Flexibility Act (5 U.S.C. 601
Agriculture, Banks, Banking, Capital, Investments, Rural areas.
Secs. 4.12, 5.9, 5.17, 8.11, 8.31, 8.32, 8.33, 8.34, 8.35, 8.36, 8.37, 8.41 of the Farm Credit Act (12 U.S.C. 2183, 2243, 2252, 2279aa-11, 2279bb, 2279bb-1, 2279bb-2, 2279bb-3, 2279bb-4, 2279bb-5, 2279bb-6, 2279cc); sec. 514 of Pub. L. 102-552, 106 Stat. 4102; sec. 118 of Pub. L. 104-105, 110 Stat. 168.
(b) * * *
(5) You will further adjust losses for loans that collateralize the general obligation of Off-Balance Sheet AgVantage volume, and for loans where the program loan counterparty retains a subordinated interest in accordance with Appendix A to this subpart.
(d) You must submit your quarterly risk-based capital report for the last day of the preceding quarter by the earlier of the reporting deadlines for Securities and Exchange Commission Forms 10-K and 10-Q, or the 40th day after each of the quarters ending March 31st, June 30th, and September 30th, and the 75th day after the quarter ending on December 31st.
Loan loss rates are determined by applying the loss-frequency equation and the loss-severity factor to Farmer Mac loan-level data. Using this equation and severity factor, you must calculate loan losses under stressful economic conditions assuming Farmer Mac's portfolio remains at a “steady state.” * * *
You must calculate the age-adjusted loss rates for these loans that include adjustments to scale losses according to the proportion of total submitted collateral to the guaranteed amount as provided for in the “Dollar Losses” column of the transformed worksheets in the Credit Loss Module based on new data inputs required in the “Coefficients” worksheet of the Credit Loss Module. Then, you must adjust the calculated loss rates as follows.
a. For loans in which the seller retains a subordinated interest, subtract from the total estimated age-adjusted dollar losses on the pool the amount equal to current unpaid principal times the subordinated interest percentage.
b. Some pools of loans underlying specific transactions could include loan collateral volume pledged to Farmer Mac in excess of Farmer Mac's guarantee amount (“overcollateral”). Overcollateral can be either: (i) Contractually required according to
1. If a pool of loans includes collateral pledged in excess of the guaranteed amount, you must adjust the age-adjusted, loan-level dollar losses by a factor equal to the ratio of the guarantee amount to total submitted collateral. For example, consider a pool of two loans serving as security for a Farmer Mac guarantee on a note with a total issuance face value of $2 million and on which the counterparty has submitted 10-percent overcollateral. The two loans in the example have the following characteristics and adjustments.
2. If a pool of loans includes collateral pledged in excess of the guaranteed amount that is required under the terms of the transaction, you must further adjust the dollar losses as follows. Calculate the total losses on the subject portfolio of loans after age adjustments and any adjustments related to total submitted overcollateral as described in “1.” above. Calculate the total dollar amount of contractually required overcollateral in the subject pool. Subtract the total dollars of contractually required overcollateral from the adjusted total losses on the subject pool. If the result is less than or equal to zero, input a loss rate of zero for this transaction pool in the Data Inputs worksheet of the RBCST. A new category must be created for each such transaction in the RBCST. If the loss rate after subtracting contractually required overcollateral is greater than zero, proceed to additional adjustment for the risk-reducing effects of the counterparty's general obligation described in “3.” below.
3. Loans with a positive loss estimate remaining after adjustments in “1.” and “2.” above are further adjusted for the security provided by the general obligation of the counterparty. To make this adjustment, multiply the estimated dollar losses remaining after adjustments in “1.” and “2.” above by the appropriate general obligation adjustment factor based on the counterparty's whole-letter issuer credit rating by a nationally recognized statistical rating organization (NRSRO).
A. The following table sets forth the general obligation adjustment factors and their components by whole-letter credit rating (Adjustment Factor = Default Rate × Severity Rate).
B. The adjustment factors will be updated annually as Moody's annual report on Default and Recovery Rates of Corporate Bond Issuers becomes available, normally in January or February of each year. In the event that there is an interruption of Moody's publication of this annual report, or FCA determines that the format of the report has changed enough to prevent or call into question the identification of updated factors, the prior year's factors will remain in effect until FCA revises the process through rulemaking.
4. Continuing the previous example, the pool contains two loans on which Farmer Mac is guaranteeing a total of $2 million and with total submitted collateral of 110 percent of the guaranteed amount. Of the 10-percent total overcollateral, 5 percent is contractually required under the terms of the transaction. The pool consists of two loans of slightly over $1 million. Total overcollateral is $200,000, of which $100,000 is contractually required. The counterparty has a single “A” credit rating, and after adjusting for contractually required overcollateral, estimated losses are greater than zero. The net loss rate is calculated as described in the steps in the table below.
A. The net, fully adjusted losses are distributed over time on a straight-line basis. When a transaction reaches maturity within the 10-year modeling horizon, the losses are distributed on a straightline over a timepath that ends in the year of the transaction's maturity.
B. [Reserved]
e.
1. Certain special cases will receive the following treatment. For an investment structured as a collateralized obligation backed by the issuer's general obligation and, in turn, a pool of collateral, reference the Issuer Rating or Financial Strength Rating of that issuer as the credit rating applicable to the security. Unrated securities that are fully guaranteed by Government-sponsored enterprises (GSE) such as the Federal National Mortgage Corporation (Fannie Mae) will receive the same treatment as AAA securities. Unrated securities backed by the full faith and credit of the U.S. Government will not receive a haircut. Unrated securities that are not fully guaranteed by a GSE will receive the haircut level in place at that time for “Below BBB and Unrated” investments unless the Director, at the Director's discretion, determines to apply a lesser haircut. In making this determination, the Director will consider the risk characteristics associated with the structure of individual instruments.
2. If portions of investments are later sold by Farmer Mac according to their specific risk characteristics, the Director will take reasonable measures to adjust the haircut level applied to the investment to recognize the change in the risk characteristics of the retained portion. The Director will consider relevant similar methods for dealing with capital requirements adopted by other Federal financial institution regulators in similar situations.
3. Individual investment haircuts must then be aggregated into weighted-average haircuts by investment category and submitted in the “Data Inputs” worksheet. The spreadsheet uses these inputs to reduce the weighted-average yield on the investment category to account for counterparty insolvency according to a 10-year linear phase-in of the haircuts. Each asset account category identified in this data requirement is discussed in section 4.2, “Assumptions and Relationships.”
b. * * *
(3)
(C) The stress test assumes that short-term cost of funds is incurred in relation to the amount of defaulting loans purchased from off-balance sheet pools. The remaining unpaid principal balance on this loan volume is the origination amount reduced by the proportion of the total portfolio that has amortized as of the end of the most recent quarter. This volume is assumed to be funded at the short-term cost of funds and this expense continues for a period equal to the loan loss resolution timing period (LLRT) period minus 1. We will calculate the LLRT period from Farmer Mac data. In addition, during the LLRT period, all guarantee income associated with the loan volume ceases.
(D) The stress test generates no interest income on the estimated volume of defaulted on-balance sheet loan volume required to be carried during the LLRT period, but continues to accrue funding costs during the remainder of the LLRT period.
(E) You must update the LLRT period in response to changes in the Corporation's actual experience with each quarterly submission.
The worksheet labeled “Loan and Cashflow Data” contains the categorized loan data and cashflow accounting relationships that are used in the stress test to generate projections of Farmer Mac's performance and condition. As can be seen in the worksheet, the steady-state formulation results in account balances that remain constant except for the effects of discontinued programs, maturing Off-Balance Sheet AgVantage positions, and the LLRT adjustment. For assets with maturities under 1 year, the results are reported for convenience as though they matured only one time per year with the additional convention that the earnings/cost rates are annualized. For the pre-1996 Act assets, maturing balances are added back to post-1996 Act account balances. The liability accounts are used to satisfy the accounting identity, which requires assets to equal liabilities plus owner equity. In addition to the replacement of maturities under a steady state, liabilities are increased to reflect net losses or decreased to reflect resulting net gains. Adjustments must be made to the long- and short-term debt accounts to maintain the same relative proportions as existed at the beginning period from which the stress test is run with the exception of changes associated with the funding of defaulted loans during the LLRT period. The primary receivable and payable accounts are also maintained on this worksheet, as is a summary balance of the volume of loans subject to credit losses.
a. Information related to income performance through time is contained on
Postal Service
Final rule.
In this final rule the Postal Service provides new mailing standards to require the use of a concatenated UCC/EAN Code 128 Service barcode with a unique Service Type Code “55” on all Priority Mail® Open and Distribute container address labels. A proposed rule was published in the
Cheryl DuBois at 202-268-3146 or Garry Rodriguez at 202-268-7281.
There were no comments received on the May 24, 2007, or April 21, 2008 proposed rules.
Priority Mail Open and Distribute is designed to enhance the Postal Service's ability to provide mailers with expedited service to destination delivery units and other mail processing facilities. Mailers are currently provided an option to use Delivery Confirmation service to receive performance information and confirmation that their containers arrived at the destination facility, along with the date, ZIP Code
In order to verify the arrival at the destination facility for all Priority Mail Open and Distribute containers, the Postal Service is requiring mailers to place a barcode on all Priority Mail Open and Distribute address labels. The barcode is required to be a concatenated UCC/EAN 128 Service barcode with a unique Service Type Code (STC) “55”. The text, “USPS SCAN ON ARRIVAL,” above the barcode is exclusive to this service and will assist in facilitating correct scan behavior.
The decision to require the use of the Service barcode instead of the Delivery Confirmation barcode will lessen any confusion as to the appropriate scans the barcode should receive and ensure the customer gets the appropriate performance information. This will provide better visibility to the customer and enable the USPS® to monitor service performance based on the product.
The requirement is in accordance with instructions for barcode specifications, electronic file format and testing, and certification process, in Publication 91,
The required use of a Service barcode with Priority Mail Open and Distribute service will be effective July 1, 2008.
The Postal Service adopts the following changes to
Administrative practice and procedure, Postal Service.
5 U.S.C. 552(a); 39 U.S.C. 101, 401, 403, 404, 414, 416, 3001-3011, 3201-3219, 3403-3406, 3621, 3622, 3626, 3632, 3633, and 5001.
No extra services are available for Priority Mail Open and Distribute containers. * * *
In addition to Tag 157, Label 23, Tag 161, or Tag 190, USPS-supplied containers and envelopes and mailer-supplied containers used for Express Mail Open and Distribute or Priority Mail Open and Distribute must bear an address label that states “OPEN AND DISTRIBUTE AT:” followed by the facility name. Find the facility name and other information for addressing the labels, according to the type of facility, in 16.5.8 through 16.5.12.
An electronic Service barcode using the concatenated UCC/EAN Code 128 symbology must be incorporated in the address label. Mailers must prepare address labels using the formats in 16.5.8 through 16.5.12, including the service type code “55” to identify the service and the human-readable text “USPS SCAN ON ARRIVAL” above the barcode. USPS certification is required from the National Customer Support Center (NCSC) for each printer used to print barcoded open and distribute address labels, except for barcodes created using USPS Shipping Assistant. NCSC contact information, formatting specifications for barcodes and electronic files, and certification, are included in Publication 91,
a. Select a service software developer from the list of companies that have met Postal Service specifications for the electronic file and barcode available at
b. Register and download the USPS Shipping Assistant desktop application available at
c. Register and integrate the USPS Web Tools Application Program Interface (API) for Priority Mail Open and Distribute using your own developers, available at
d. Use Publication 91,
* * * For the DDU address label, use the destination facility name, the street address, city, state, and ZIP+4 found in the Drop Entry Point View File available at USPS' FAST Web site:
For the SCF address label, use SCF followed by the city, state, and ZIP Code found in the Drop Entry Point View File available at USPS' FAST Web site:
For the ADC address label, use ADC followed by the city, state, and ZIP Code found in the Drop Entry Point View File available at USPS' FAST Web site:
For the BMC address label, use BMC followed by the city, state, and ZIP Code found in the Drop Entry Point View File available at USPS' FAST Web site:
For the ASF address label, use ASF followed by the city, state, and ZIP Code found in the Drop Entry Point View File under BMC available at USPS' FAST Web site:
Federal Emergency Management Agency, DHS.
Final rule, correction.
On May 7, 2008, FEMA published in the
William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646-3151 or (e-mail)
The Federal Emergency Management Agency (FEMA) publishes proposed determinations of Base (1% annual-chance) Flood Elevations (BFEs) and modified BFEs for communities participating in the National Flood Insurance Program (NFIP), in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
These final BFEs and modified BFEs, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own, or pursuant to policies established by other
In the final rule published at 73 FR 25542 in the May 7, 2008 issue of the
U.S. Nuclear Regulatory Commission.
Notice of document availability and request for public comment.
The U.S. Nuclear Regulatory Commission (NRC) is announcing the availability of and is seeking public comment on the draft NUREG-1886, “Joint Canada—United States Guide for Approval of Type B(U) and Fissile Material Transportation Packages.”
Comments on this document should be submitted by August 19, 2008. Comments received after this date will be considered if it is practical to do so, however we are only able to assure consideration for comments received on or before this date. To ensure efficient and complete comment resolution, comments should include reference to the section, page, and line numbers of the document to which the comment applies, if possible.
Members of the public are invited and encouraged to submit written comments to Michael T. Lesar, Chief, Rulemaking, Directives and Editing Branch, Mail Stop T6-D59, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. Comments may be submitted by electronic mail to
Copies of comments received may be viewed at the NRC's Public Document Room, One White Flint North, Public File Area O1-F21, 11555 Rockville Pike (First Floor), Rockville, Maryland.
This document, NUREG-1886 [ML073300230], is available at the NRC's Agencywide Document Access and Management System (ADAMS) Public Electronic Reading Room on the Internet, accessible through the NRC's public Web site at
Michele M. Sampson, Office of Nuclear Material Safety and Safeguards, NRC, Washington, DC 20555-0001; telephone: (301) 492-3292; e-mail:
The International Atomic Energy Agency (IAEA) “Regulations for the Safe Transport of Radioactive Material” (TS-R-1) are designed to provide a uniform and adequate level of safety for the transport of radioactive materials. The standards for packaging of radioactive material, the IAEA regulations, TS-R-1, are adopted by member states, providing the basis for each member state's transport package approval. In principle, this “unilateral” approval can be accepted by all other member states, with little or no requirement for additional technical review. However, the U.S. and other member states have routinely performed some form of technical review for Type B(U) and fissile material transport packages.
Under the U.S. Department of Transportation (DOT) regulations, 49 Code of Federal Regulations (CFR) part 173.471-473, for a Type B or fissile material package design, a “U.S. Competent Authority Certificate” must be obtained from the DOT prior to import or export of Type B or fissile material packages. The June 8, 1979, Memorandum of Understanding (MOU; 44 FR 38690, July 2, 1979) describes the roles and responsibilities of both DOT and NRC in jointly regulating the transportation of radioactive material in the U.S. DOT, assisted by NRC as needed, performs a technical review as part of validation for each foreign-approved package design prior to issuance of a U.S. Certificate of Competent Authority.
In practice, the acceptance of approvals for Type B(U) and fissile material packages, without additional package review by affected member states, has remained an elusive goal. Implementation of a separate technical review is influenced by the perspectives that individual member states have concerning risk, safety margins, and because of other differences in engineering standards, documentation, and quality assurance requirements. Progress towards member state acceptance of Type B(U) and fissile materials transportation packages requires a framework in which these different perspectives, as well as the qualification of technical reviewers, can be addressed, resolved, and documented.
The purpose of this NUREG is to provide the framework to achieve United States and Canadian validation of Competent Authority Type B(U) and fissile materials transportation package approvals for export and import without significant additional technical review.
The NUREG was developed by a working group of DOT, NRC, and Canadian Nuclear Safety Commission (CNSC) staff. The NUREG is to be used by applicants in submitting safety analysis reports for the certification of packages and by DOT and NRC reviewers in assessing these reports. The NUREG describes a method that is acceptable to the staffs of the DOT, NRC, and CNSC for complying with the United States regulations in 10 CFR part 71 and 49 CFR part 173, the Canadian Packaging and Transport of Nuclear Substances Regulations, and TS-R-1, upon which the domestic United States and Canadian regulations are based. Where differences in the regulatory requirements exist, guidance is provided in the NUREG to assist the applicant in appropriately addressing the specific regulatory requirement. The
The NUREG applies specifically to applications for approval of Type B(U) and fissile material (Type A and Type B) transportation packages for import or export. The NUREG does not apply to approval of special form materials, certain air shipments of Type B packages, low dispersible material, Type C packages, or fissile materials in less than Type A packages. The NUREG does not change the certification requirements for domestic shipment within the United States or Canada.
The CNSC has a companion Regulatory Document, “Joint Canada—United States Guide for Approval of Type B(U) and Fissile Material Transportation Packages” (RD-364) which provides the same guidance to applicants in submitting safety analysis reports to the CNSC for the certification of packages and to CNSC reviewers in assessing these reports, as NUREG-1886. The CNSC document is being published for public comment in Canada.
The United States and Canada, through the working group process, envision a formal process, such as a Memorandum of Agreement, to implement use of NUREG-1886 in the United States and RD-364 in Canada. The protocol for implementation of this formal agreement is expected to detail the process to be followed by the United States and Canada.
The following elements have been identified for implementation:
• Procedures for periodic review of both NUREG-1886 and RD-364 to ensure the documents remain current with regulatory changes.
• NRC and CNSC agreement on minimum qualification of staff assigned to review packages that are part of the bi-lateral agreement.
• Periodic audit by NRC and CNSC of each other's review process.
• Periodic full review by both NRC and CNSC of packages that are part of the bi-lateral agreement.
• Periodic meetings between NRC, DOT, and CNSC staff to discuss technical issues related to package approvals that are part of the bi-lateral agreement.
The formal bi-lateral agreement between NRC, DOT, and CNSC will be made available to the public through a separate notice in the
The NRC is seeking public comment in order to receive feedback from the widest range of interested parties and to ensure that all information relevant to developing NUREG-1886 is available to the NRC staff. The NRC will provide copies of public comments received to the CNSC and DOT. In addition, public comments received by the CNSC on RD-364 will be provided to the NRC and DOT. The NRC will review all public comments, incorporate suggested changes as necessary, and then issue the final NUREG-1886 for use.
For the Nuclear Regulatory Commission.
Environmental Protection Agency (EPA).
Proposed rule.
EPA is proposing to approve a State Implementation Plan (SIP) revision submitted by the Commonwealth of Pennsylvania. The Pennsylvania Department of Environmental Protection (PADEP) submitted a SIP revision consisting of a maintenance plan that provides for continued attainment of the 8-hour ozone national ambient air quality standard (NAAQS) for at least 10 years after the April 30, 2004 designations, as well as a 2002 base-year inventory for the Schuylkill County Area. EPA is proposing approval of the maintenance plan and the 2002 base-year inventory in accordance with the requirements of the Clean Air Act (CAA).
Written comments must be received on or before July 7, 2008.
Submit your comments, identified by Docket ID Number EPA-R03-OAR-2008-0189 by one of the following methods:
A.
B.
C.
D.
Melissa Linden, (215) 814-2096, or by e-mail at
On December 17, 2007, PADEP formally submitted for approval, under section 110(a)(1) of the CAA, a SIP revision for the 8-hour ozone maintenance plan and the 2002 base-year inventory for the Schuylkill County Area.
Section 110(a)(1) of the CAA requires that states submit to EPA plans to maintain the NAAQS promulgated by EPA. EPA interprets this provision to require that areas that were maintenance areas for the 1-hour ozone NAAQS, but attainment for the 8-hour ozone NAAQS, submit a plan to demonstrate the continued maintenance of the 8-hour ozone NAAQS.
On May 20, 2005, EPA issued guidance that applies to areas that are designated unclassifiable/attainment for the 8-hour ozone standard. The purpose of this guidance is to address the maintenance requirements in section 110(a)(1) of the CAA, and to assist the states in the development of a SIP. The components from EPA's guidance include: (1) An attainment emissions inventory, which is based on actual “typical summer day” emissions of volatile organic compounds (VOCs) and nitrogen oxides (NO
The Commonwealth of Pennsylvania has requested approval of its 8-hour ozone maintenance plan and 2002 base-year inventory for the Schuylkill County Area. The PADEP 8-hour ozone maintenance plan addresses the five components of EPA's May 20, 2005 guidance, which pertains to the maintenance requirements in section 110(a)(1) of the CAA.
Pennsylvania projected emissions for beyond 10 years from the effective date of the April 30, 2004 designations for the 8-hour ozone standard. PADEP has developed an emissions inventory for ozone precursors for the year 2002, 2009, and 2018. Tables 1 and 2 show the VOCs and NO
Based upon the comparison of the projected emissions and the 2002 base-year inventory emissions, along federal and state measures, EPA concludes that PADEP successfully demonstrates that the 8-hour ozone standard will be maintained in the Schuylkill County Area. Further details of Schuylkill County Attainment Area's 8-hour ozone maintenance demonstration can be found in a Technical Support Document (TSD) prepared for this rulemaking.
Since the Schuylkill County Area does not have a monitor, contingency measures will be considered if for two consecutive years the fourth highest 8-hour ozone concentrations at the design monitor for the Reading Area are above 84 parts per billion (ppb). If this trigger point occurs, PADEP will evaluate whether additional local emission control measures should be implemented in Schuylkill County in order to prevent a violation of the air quality standard. PADEP will analyze the conditions leading to the excessive ozone levels and evaluate what measures might be most effective in correcting the excessive ozone levels. PADEP will also analyze the potential emissions effect of federal, state, and local measures that have been adopted but not yet implemented at the time the excessive ozone levels occurred. PADEP will then begin the process of implementing the contingency measures outlined in their maintenance plan.
EPA is proposing to approve the maintenance plan and the 2002 base-year inventory for the Schuylkill County Area, submitted on December 17, 2007, as revisions to the Pennsylvania SIP. EPA is proposing to approve the maintenance plan and 2002 base-year inventory for the Schuylkill County Area because it meets the requirements of section 110(a)(1) of the CAA. EPA is soliciting public comments on the issues discussed in this document. These comments will be considered before taking final action.
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely proposes to approve state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, this proposed rule to approve the maintenance plan and the 2002 base-year inventory for the Schuylkill County Area in the Commonwealth of Pennsylvania does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.
Environmental protection, Air pollution control, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
42 U.S.C. 7401 et seq.
Food Safety and Inspection Service, USDA.
Notice.
This notice informs the public of the sanitary and phytosanitary standard-setting activities of the Codex Alimentarius Commission (Codex), in accordance with section 491 of the Trade Agreements Act of 1979, as amended, and the Uruguay Round Agreements Act, Public Law 103-465, 108 Stat. 4809. This notice also provides a list of other standard-setting activities of Codex, including commodity standards, guidelines, codes of practice, and revised texts. This notice, which covers the time periods from June 1, 2007, to May 31, 2008, and June 1, 2008, to May 31, 2009, seeks comments on standards under consideration and recommendations for new standards.
Comments may be submitted by any of the following methods:
•
• Mail, including floppy disks or CD-ROMs, and hand- or courier-delivered items: Send to Docket Clerk, U.S. Department of Agriculture, Food Safety and Inspection Service, Room 2534, South Agriculture Building, 1400 Independence Avenue, SW., Washington, DC 20250-3700.
All submissions must include the Agency name and docket number FSIS-2008-0004. Please state that your comments refer to Codex and, if your comments relate to specific Codex committees, please identify those committees in your comments and submit a copy of your comments to the delegate from that particular committee. All comments submitted in response to this proposal will be posted to the regulations.gov Web site. The comments also will be available for public inspection in the FSIS Docket Room at the address listed above between 8:30 a.m. and 4:30 p.m., Monday through Friday. The comments also will be posted on the Agency's Web site at
Karen Hulebak, PhD, Acting Manager, U.S. Codex Office, U.S. Department of Agriculture, Office of the Under Secretary for Food Safety, Room 4861, South Agriculture Building, 1400 Independence Avenue, SW., Washington, DC 20250-3700; (202) 205-7760. For information pertaining to particular committees, the delegate of that committee may be contacted. (A complete list of U.S. delegates and alternate delegates can be found in Attachment 2 to this notice.) Documents pertaining to Codex are accessible via the World Wide Web at the following address:
The World Trade Organization (WTO) was established on January 1, 1995, as the common international institutional framework for the conduct of trade relations among its members in matters related to the Uruguay Round Trade Agreements. The WTO is the successor organization to the General Agreement on Tariffs and Trade (GATT). U.S. membership in the WTO was approved and the Uruguay Round Agreements Act was signed into law by the President on December 8, 1994. The Uruguay Round Agreements became effective, with respect to the United States, on January 1, 1995. Pursuant to section 491 of the Trade Agreements Act of 1979, as amended, the President is required to designate an agency to be “responsible for informing the public of the sanitary and phytosanitary (SPS) standard-setting activities of each international standard-setting organization.” The main organizations are Codex, the World Organisation for Animal Health, and the International Plant Protection Convention. The President, pursuant to Proclamation No. 6780 of March 23, 1995 (60 FR 15845), designated the U.S. Department of Agriculture as the agency responsible for informing the public of SPS standard-setting activities of each international standard-setting organization. The Secretary of Agriculture has delegated to the Administrator, Food Safety and Inspection Service (FSIS), the responsibility to inform the public of the SPS standard-setting activities of Codex. The FSIS Administrator has, in turn, assigned the responsibility for informing the public of the SPS standard-setting activities of Codex to the U.S. Codex Office, FSIS.
Codex was created in 1962 by two U.N. organizations, the Food and Agriculture Organization (FAO) and the World Health Organization (WHO). Codex is the principal international organization for encouraging fair international trade in food and protecting the health and economic interests of consumers. Through adoption of food standards, codes of practice, and other guidelines developed by its committees and by promoting their adoption and implementation by governments, Codex seeks to protect the health of consumers, ensure fair trade practices in the food trade, and promote coordination of food standards work undertaken by international governmental and non-governmental organizations. In the United States, the United States Department of Agriculture (USDA) the Food and Drug Administration (FDA),
As the agency responsible for informing the public of the SPS standard-setting activities of Codex, FSIS publishes this notice in the
1. The SPS standards under consideration or planned for consideration; and
2. For each SPS standard specified:
a. A description of the consideration or planned consideration of the standard;
b. Whether the United States is participating or plans to participate in the consideration of the standard;
c. The agenda for United States participation, if any; and
d. The agency responsible for representing the United States with respect to the standard.
The United States delegate will facilitate public participation in the United States Government's activities relating to Codex Alimentarius. The United States delegate will maintain a list of individuals, groups, and organizations that have expressed an interest in the activities of the Codex committees and will disseminate information regarding United States delegation activities to interested parties. This information will include the status of each agenda item; the United States Government's position or preliminary position on the agenda items; and the time and place of planning meetings and debriefing meetings following Codex committee sessions. In addition, the U.S. Codex Office makes much of the same information available through its Web page,
The information provided in Attachment 1 describes the status of Codex standard-setting activities by the Codex Committees for the time periods from June 1, 2007, to May 31, 2008, and June 1, 2008, to May 31, 2009. Attachment 2 provides the list of U.S. Codex Officials (includes U.S. delegates and alternate delegates). A list of forthcoming Codex sessions may be found at:
Public awareness of all segments of rulemaking and policy development is important. Consequently, in an effort to ensure that minorities, women, and persons with disabilities are aware of this notice, FSIS will announce it online through the FSIS Web page located at
The Codex Alimentarius Commission will hold its Thirty-First Session June 30-July 4, 2008, in Rome, Italy. At that time, it will consider standards, codes of practice, and related matters brought to its attention by the general subject committees, commodity committees,
Prior to the Commission meeting, the Executive Committee will have met at its Sixty-First Session on June 24-27, 2008. It is composed of the chairperson, vice-chairpersons, and seven members elected from the Commission, one from each of the following geographic regions: Africa, Asia, Europe, Latin America and the Caribbean, Near East, North America, and South-West Pacific. Additionally, regional coordinators from the six regional committees serve as members of the Executive Committee. It will consider the Codex Strategic Plan 2008-2013; review the Codex committee structure and mandate of Codex committees and task forces; review matters arising from reports of Codex Committees, proposals for new work, and standards management issues; and review the Trust Fund.
The Codex Committee on Residues of Veterinary Drugs in Foods determines priorities for the consideration of residues of veterinary drugs in foods and recommends Maximum Residue Limits (MRLs) for veterinary drugs. The Committee also develops codes of practice as may be required and considers methods of sampling and analysis for the determination of veterinary drug residues in food. A veterinary drug is defined as any substance applied or administered to a food producing animal, such as meat or
A Codex Maximum Limit for Residues of Veterinary Drugs (MRLVD) is the maximum concentration of residue resulting from the use of a veterinary drug (expressed in mg/kg or ug/kg on a fresh weight basis) that is recommended by the Codex Alimentarius Commission to be permitted or recognized as acceptable in or on a food. An MRLVD is based on the type and amount of residue considered to be without any toxicological hazard for human health as expressed by the Acceptable Daily Intake (ADI) or on the basis of a temporary ADI that utilizes an additional safety factor. The MRLVD also takes into account other relative public health risks as well as food technological aspects.
When establishing an MRLVD, consideration is also given to residues that occur in food of plant origin or the environment. Furthermore, the MRLVD may be reduced to be consistent with good practices in the use of veterinary drugs and to the extent that practical analytical methods are available.
An Acceptable Daily Intake (ADI) is an estimate by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) of the amount of a veterinary drug, expressed on a body weight basis, that can be ingested daily over a lifetime without appreciable health risk (standard man = 60 kg).
The 17th Session of the Codex Committee on Residues of Veterinary Drugs in Foods met in Breckenridge, Colorado, on September 3-7, 2007.
The following items will be considered by the Commission at its 31st Session in June 2008.
To be considered at Step 8:
• Draft MRLs for Colistin in cattle, sheep, goat, pig, chicken, turkey and rabbit tissues, in cattle and sheep's milk and in chicken eggs, Ractopamine in cattle and pig tissues
To be considered at Step 5/8:
• Proposed Draft Maximum Residue Limits for Erythromycin in chicken and turkey tissues
The Committee completed work on the following:
• At the 17th CCRVDF, the Committee completed a Priority of Veterinary Drugs Requiring Evaluation or Reevaluation by JECFA. These drugs are Dexamethasome, Tylosin, Avilamycin, Malachite Green, Tilmicosin, Monensin, Narasin, Triclabendazole, Melengestrol acetate.
The Committee will continue work on the following:
• Draft Maximum Residue Limits for Erythromycin.
• Draft Maximum Residue Limits for Melengesterol Acetate (MGA) in cattle tissue.
• Proposed Draft Maximum Residue Limits for Triclabendazole in cattle, sheep and goat tissues.
• Draft Guidelines for the Design and Implementation of National Regulatory Food Safety Assurance Programmes Associated with the Use of Veterinary Drugs in Foods.
• Proposed Draft Risk Management Recommendation/Guidance for Veterinary Drugs for which no ADI and MRL have been recommended by JECFA due to specific health concerns.
• Discussion Paper on Consideration of Methods of Analysis and Sampling in CCRVDF (Report of the Electronic Working Group on Methods of Analysis and Sampling).
• Draft Priority List of Veterinary Drugs Requiring Evaluation or Re-evaluation by JECFA and Working Document Listing Veterinary Drugs of Potential Interest (Report of the Electronic Working Group on Priority).
• Discussion Paper on Current Practices and Needs for Further Work by the Committee on the Use of the Estimated Daily Intake (EDI) concept; Utilization of full ADI; Starter culture; and Appending Risk Management. Recommendation(s) to MRLs (Report of the Electronic Working Group on Risk Management Topics and Options for the CCRVDF)
The following work will be discontinued:
• Draft and Proposed Draft Maximum Residue Limits for Flumequine (Black tiger shrimp and shrimps).
The Codex Committee on Contaminants in Foods (CCCF) was established by the 29th Session of the Commission when it decided to split the former Codex Committee on Food Additives and Contaminants into two committees. The CCCF establishes or endorses permitted maximum levels for contaminants and naturally occurring toxicants in food and feed, prepares priority lists of contaminants and naturally occurring toxicants for risk assessment by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), considers methods of analysis and sampling for the determination of contaminants and naturally occurring toxicants in food and feed, considers and elaborates standards or codes of practice for related subject, and considers other matters assigned to it by the Commission in relation to contaminants and naturally occurring toxicants in food and feed. The Committee held its second session in The Hague, Netherlands from March 31st-April 4, 2008. The relevant document is ALINORM 08/31/41. The following items are to be considered by the 31st Session of the Commission from June 30-July 4, 2008.
To be considered for adoption:
• Proposed Draft Provisions Applied to Contaminants in the “Relations between Commodity Committees and General Committees” in the Procedural Manual.
• Priority List of Contaminants and Naturally Occurring Toxicants Proposed for Evaluation by JECFA.
To be considered at Step 8:
• Draft Maximum Level for 3-MCPD in Liquid Condiments Containing Acid-Hydrolyzed Vegetable Oriteins (Excluding Naturally Fermented Soy Sauce).
• Draft Code of Practice for Reduction of 3-Monocloropropane-1,2-diol (3-MCPD) during the Production of Acid-Hydrolyzed Vegetable Protein (Acid-HVPs) and Products that Contain Acid-HVPs.
• Draft Maximum Level for Ochratoxin A in Raw Wheat, Barley and Rye.
• Draft Maximum Levels for Total Aflatoxins in Almonds, Hazelnuts, and Pistachios “For further processing” and “Ready to eat.”
To be considered at Step 5/8:
• Proposed Draft Aflatoxin Sampling Plans for Aflatoxin Contamination in Ready-to-Eat Treenuts and Treenuts Destined for Further Processing: Almonds, Hazelnuts and Pistachios.
• Proposed Draft Code of Practice for the Prevention and Reduction of Aflatoxin Contamination in Dried Figs.
To be considered at Step 5:
• Proposed Draft Code of Practice for the Reduction of Acrylamide in Food.
• Proposed Draft Code of Practice for the Reduction of Contamination of Food with Polycyclic Aromatic Hydrocarbons (PAH) from Smoking and Direct Drying Processes.
• Proposed Draft Maximum Levels for Total Aflatoxins in Brazil Nuts.
• Proposed Draft Code of Practice for the Prevention and Reduction of Ochratoxin A Contamination in Coffee.
The Committee is continuing to work on:
• Proposed Draft Revision of the Preamble of the GSCTF.
• Discussion Paper on Fumonisins.
• Discussion Paper on Benzene in Soft Drinks.
• Discussion Paper on Cyanogenic Glycosides.
• Discussion Paper on Mycotoxins in Sorghum.
• Discussion Paper on Ethyl Carbamate in Alcoholic Beverages.
The Codex Committee on Food Additives was re-established by the 29th Session of the Commission, which split the former Codex Committee on Additives and Contaminants into two committees. The Committee is to establish or endorse permitted maximum levels for individual food additives, prepare a priority list of food additives for risk assessment by JECFA, assign functional classes to individual food additives, recommend specifications of identity and purity for food additives for adoption by the Commission, consider methods of analysis for the determination of additives in food, and to consider and elaborate standard for codes for related subjects such as the labeling of food additives when sold as such. The Committee met in Beijing, China, on April 15-25, 2008. The relevant document is ALINORM 8/31/12. The following items will be considered by the 31st Session of the Commission in June 2008.
To be considered for adoption:
• Amendment to the Annex to Table 3 of the GFSA.
• Amendment to the provisions for colours of GFSA.
• Priority List of Food Additives Proposed for Evaluation by JECFA.
To be considered at Step 8 and 5/8:
• Draft and proposed draft food additive provisions of the General Standard for Food Additives (GSFA).
• Draft and proposed draft Guidelines for the Use of Flavourings for adoption at Step 8 (Sections 1, 2, 3, 5, 6 and 7) and Step 5/8 (Section 4).
To be considered at Step 8:
• Draft revision of the Codex Class Names and International Numbering System for Food Additives—CAC/GL 36-2003.
To be considered at Step 5/8:
• Proposed draft revision of the Food Category System (FCF) of the GSFA.
• Proposed draft amendments to the International Numbering System (INS) for Food Additives.
• Proposed and Draft Specifications for the Identity and Purity of Food Additives.
The Committee will continue to work on:
• Draft and proposed draft Food Additive Provisions of the GSFA.
• Guidelines and Principles for the Use of Substances used as Processing Aids.
• Amendments to the INS List.
• Specifications for the Identity and Purity of Food Additives arising from the 69th JECFA meeting.
• Discussion Paper on Scope of Selected Food Categories and Use of Colours.
• Report of the Electronic Working Group on the GSFA.
• Discussion Paper on Identification of Problems and Recommendations Related to the Inconsistent Presentation of Food Additive Provisions in Codex Commodity Standards.
• Inventory of Substances Used as Processing Aids (IPA).
• Discussion Paper on Inconsistencies in the Names of Compounds in Codex Specifications and the INS.
• Priority List of Food Additives Proposed for Evaluation by JECFA (including proposals for the revision of the Circular Letter).
• Working Document for Information and Support to the Discussion on the GSFA.
• Food Additive Provisions of the General Standard for Food Additives (GSFA).
• Codex
• Codex
• Draft and Proposed Draft Food Additive Provisions of the General Standard for Food Additives (GSFA).
The Codex Committee on Pesticide Residues recommends to the Codex Alimentarius Commission establishment of maximum limits for pesticide residues for specific food items or in groups of food. A Codex Maximum Residue Limit for Pesticide (MRLP) is the maximum concentration of a pesticide residue (expressed as mg/kg), recommended by the Codex Alimentarius Commission to be legally permitted in or on food commodities and animal feeds. Foods derived from commodities that comply with the respective MRLPs are intended to be toxicologically acceptable, that is, consideration of the various dietary residue intake estimates and determinations both at the national and international level in comparison with the ADI*, should indicate that foods complying with Codex MRLPs are safe for human consumption.
Codex MRLPs are primarily intended to apply in international trade and are derived from reviews conducted by the Joint Meeting on Pesticide Residues (JMPR).
(a) Review of residue data from supervised trials and supervised uses, including those reflecting national good agricultural practices (GAP). Data from supervised trials conducted at the highest nationally recommended, authorized, or registered uses are included in the review. In order to accommodate variations in national pest control requirements, Codex MRLPs take into account the higher levels shown to arise in such supervised trials, which are considered to represent effective pest control practices.
(b) Toxicological assessments of the pesticide and its residue. The 40th Session of the Committee met in Hangzhou, China, on April 14-19, 2008. The relevant document is ALINORM 08/31/24. The following items will be considered by the Commission at its 31st Session in June 2008.
To be considered at Step 8:
• Draft and Revised Draft Maximum Residue Limits.
To be considered at Step 5/8:
• Proposed Draft and Revised Draft Maximum Residue Limits.
To be considered at Step 5:
• Proposed Draft Maximum Residue Limits.
The committee is continuing work on:
• Proposed Draft and Draft Maximum Residue Limits Retained at Steps 7 and 4.
• Draft Maximum Residue Limits returned to Step 6.
• Proposed Draft Revision of the Codex Classification of Foods and Animal Feeds.
• Achieving Globally Harmonized Maximum Residue Limits through Codex.
• Priority List of Pesticides (New Pesticides and Pesticides under Periodic Review).
• The Estimation of Measurement Uncertainty.
• Revision of the CCPR Risk Analysis Principles.
• Establishing a CCPR working group on Minor Uses and Specialty Crops.
• Discontinuation of work on the Proposed Draft and Draft Maximum Residues Limits for Pesticides.
• Codex Maximum Residue Limits Recommended for Revocation.
The Codex Committee on Methods of Analysis and Sampling:
(a) Defines the criteria appropriate to Codex Methods of Analysis and Sampling;
(b) Serves as a coordinating body for Codex with other international groups working in methods of analysis and sampling and quality assurance systems for laboratories;
(c) Specifies, on the basis of final recommendations submitted to it by the other bodies referred to in (b) above, Reference Methods of Analysis and Sampling appropriate to Codex Standards which are generally applicable to a number of foods;
(d) Considers, amends if necessary, and endorses as appropriate methods of analysis and sampling proposed by Codex (Commodity) Committees, except that methods of analysis and sampling for residues of pesticides or veterinary drugs in food, the assessment of microbiological quality and safety in food, and the assessment of specifications for food additives do not fall within the terms of reference of this Committee;
(e) Elaborates sampling plans and procedures, as may be required;
(f) Considers specific sampling and analysis problems submitted to it by the Commission or any of its Committees; and
(g) Defines procedures, protocols, guidelines or related texts for the assessment of food laboratory proficiency, as well as quality assurance systems for laboratories.
The 29th Session of the Committee met in Budapest, Hungary, on March 10-14, 2008. The relevant document is ALINORM 08/31/23. The following items will be considered by the 31st Session of the Commission in June 2008:
To be adopted:
• Proposed Amendment to the Working Instructions for the Implementation of the Criteria Approach in Codex.
• Endorsement of Methods of Analysis in Draft Standards and Existing Standards.
To be adopted at Step 5:
• Proposed Draft Guidelines on Analytical Terminology.
The Committee will continue to work on:
• Draft Guidelines for Evaluating Acceptable Methods of Analysis.
• Draft Guidelines for Settling of Disputes on Analytical (Test) Results.
• Guidance on Uncertainty from Sampling.
• Consideration of Methods of Analysis for Dioxins and Dioxin-like PCBs.
• Conformity Assessment in the Presence of Significant Measurement Error (Question referred by the Committee on Milk and Milk Products).
• Proposed Draft Guidelines for Criteria for Methods for the Detection and Identification of Foods Derived from Biotechnology.
• Guidance on measurement uncertainty and uncertainty of sampling (Proposed Draft Revision of the Guidelines on Measurement Uncertainty).
• Guidelines for establishing methods criteria for identification of relevant analytical methods.
The Codex Committee on Food Import and Export Inspection and Certification Systems is charged with developing principles and guidelines for food import and export inspection and certification systems to protect consumers and to facilitate trade. Additionally, the Committee develops principles and guidelines for the application of measures by competent authorities to provide assurance that foods comply with essential requirements, especially statutory health requirements. This encompasses work on equivalence of food inspection systems, including equivalence agreements, processes and procedures to ensure that sanitary measures are implemented; guidelines on food import control systems; and guidelines on food product certification and information exchange. The development of guidelines for the appropriate utilization of quality assurance systems to ensure that foodstuffs conform to requirements and to facilitate trade also are included in the Committee's terms of reference. The Committee met November 26-30, 2007. The reference document is ALINORM 08/31/30. The following will be considered for adoption by the Commission at its 31st Session in June 2008.
To be considered at step 5/8:
• Proposed Draft Appendix to the Guidelines on the Judgement of Equivalence of Sanitary Measures Associated with Food Inspection and Certification (N04-2004).
The committee is continuing work on:
• Proposed Draft Guidelines for the Conduct of Foreign Audit Team Inspections.
• Proposed Draft Generic Template for Health Certificates.
• Discussion Paper on the Need for Guidance for National Food Inspection Systems.
• Discussion Paper on the Need for Guidance on Traceability/Product Tracing.
The Codex Committee on General Principles deals with procedure and general matters as are referred to it by the Codex Alimentarius Commission. The 25th Session is tentatively scheduled to be held in Paris, France, in April 2009. The Committee will continue to work on the following items:
• Proposed Draft Working Principles for Risk Analysis for Food Safety for Application by Governments.
• Proposed Draft Revised Code of Ethics for International Trade in Food.
• Recommendations from CCFICS related to the code of ethics.
The Codex Committee on Food Labelling drafts provisions on labeling applicable to all foods; considers, amends, and endorses draft specific provisions on labeling prepared by the Codex Committees drafting standards, codes of practice and guidelines; and studies specific labeling problems assigned by the Codex Alimentarius Commission. This Committee also studies problems associated with the advertisement of food with particular reference to claims and misleading descriptions. The Committee held its 36th Session in Ottawa, Canada, on April 28-May 2, 2008. The reference document is ALINORM 08/31/22. The following items are to be considered by the 31st Session of the Commission from June 30-July 4, 2008.
To be considered at Step 8:
• Draft Amendment to the Guidelines for the Production, Processing, Labelling and Marketing of Organically Produced Foods: Annex 1 (inclusion of Ethylene for Kiwifruit and Bananas).
• Draft Amendment to the General Standard for the Labelling of Prepackaged Foods: Quantitative Declaration of Ingredients.
• Draft Definition of Advertising in Relation to Nutrition and Health Claims (Draft Amendment to the Guidelines for Use of Nutrition and Health Claims).
The Committee will continue to work on:
• Draft Amendment to the Guidelines for the Production, Processing, Labelling
• Draft Amendment to the General Standard for the Labelling of Prepackaged Foods (Draft Recommendations for the Labelling of Foods Obtained through Certain Techniques of GM/GE): Definitions.
• Proposed Draft Recommendations for the Labelling of Foods and Food Ingredients Obtained through Certain Techniques of GM/GE.
The Committee agreed to undertake new work on:
• Amendment to the Guidelines for Production, Processing, Labelling and Marketing of Organically Produced Foods (rotenone).
• Revision of the Guidelines on Nutrition Labelling (Implementation of the Global Strategy for Diet, Physical Activity and Health).
The Committee agreed to discontinue work on:
• Draft Amendment to the Guidelines for the Production, Processing, Labelling and Marketing of Organically Produced Foods: Annex 2—Permitted Substances: Table 3.
The Codex Committee on Food Hygiene has four primary responsibilities. The first is to draft basic provisions on food hygiene applicable to all food. These provisions normally take the form of Codes of Hygienic Practice for a specific commodity (e.g. bottled water) or group of commodities (e.g., milk and milk products). The second is to suggest and prioritize areas where there is a need for microbiological risk assessment at the international level and to consider microbiological risk management matters in relation to food hygiene and in relation to the risk assessment activities of FAO and WHO. The third is to consider, amend if necessary, and endorse food hygiene provisions that are incorporated into specific Codex commodity standards by the Codex Commodity Committees. The fourth and final responsibility is to provide such other general guidance to the Commission on matters relating to food hygiene as may be necessary. The 39th Session of the Committee met in New Delhi, India, on October 30-November 4, 2007. The relevant document is ALNORM 08/31/13.
The following items related to the activities of the Codex Committee on Food Hygiene will be considered by the Commission at its 31st Session in June 2008.
To be considered for adoption at Step 5/8:
• Proposed Draft Code of Hygienic Practice for Powdered Formulae for Infants and Young Children.
• Proposed Draft Guidelines for the Validation of Food Safety Control Measures.
• Annex II: Guidance on Microbiological Risk Management Metrics (annex to the Principles and Guidelines for the Conduct of Microbiological Risk Management).
To be considered for approval as New Work:
• Proposed Draft Annex on Leafy Green Vegetables Including Leafy Herbs (annex to the Code of Hygienic Practice for Fresh Fruits and Vegetables).
• Proposed Draft Code of Hygienic Practice for
To be considered for discontinuance of work:
• Application of Food Safety Metrics in Risk Management Decision Making—Pasteurized Liquid Whole Eggs (Annex to the Code of Hygienic Practice for Egg and Egg Products).
The Committee will continue or begin work on:
• Annex on the Proposed Draft Microbiological Criteria for
• Annex II: Microbiological Criteria for Powdered Follow-up Formula and Formula for Special Medical Purposes for Young Children (Annex to the Code of Hygienic Practice for Powdered Formulae for Infants and Children).
• Proposed Draft Guidelines for the Control of
• Risk Analysis Policy of the Codex Committee on Food Hygiene.
The Codex Committee on Fresh Fruits and Vegetables is responsible for elaborating world-wide standards and codes of practice for fresh fruits and vegetables. The 14th Session of the Committee met in Mexico City, Mexico on May 12-17, 2008. The relevant document is ALINORM 08/31/35. The following items will be considered by the Commission at its 31st Session in June 2008.
To be considered at Step 8:
• Draft Codex Standard for Tomatoes.
• Draft Codex Standard for Bitter Cassava.
To be considered at Step 5:
• Draft Codex Standard for Apples.
The Committee will continue working on:
• Layout for Codex Standards on Fresh Fruits and Vegetables.
• Amendments to the Priority List for the Standardization of Fresh Fruits and Vegetables.
• Revision of the Codex Standard for Avocado.
• Proposed New Codex Standard for Durian.
• Proposed New Codex Standard for Chili Pepper.
• Proposed New Codex Standard for Tree Tomatoes.
• Draft Codex Guidelines for the Inspection and Certification of Fresh Fruits and Vegetables for Conformity to Quality Standards.
The Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) is responsible for studying nutrition issues referred by the Codex Alimentarius Commission. The Committee also drafts general provisions, as appropriate, on nutritional aspects of all foods and develops standards, guidelines, or related texts for foods for special dietary uses. The Committee met November 12-16, 2007, in Bad Neuenahr-Ahrweiler, Germany. The relevant document is ALINORM 08/31/26. The following items will be considered by the 31st Session of the Commission in June 2008.
To be adopted at Step 8:
• Draft Revised Codex Standard for Foods for Special Dietary Use for Persons Intolerant to Gluten.
• Draft Advisory Lists of Nutrient Compounds for Use in Foods for Special Dietary Uses Intended for Infants and Young Children.
To be adopted at Step 5:
• Draft Nutritional Risk Analysis Principles and Guidelines for Application to the Work of the Codex Committee on Nutrition and Foods for Special Dietary Uses.
The Committee will continue work on:
• Guidelines for Use of Nutrition Claims: Draft Table of Conditions for Nutrient Contents (Part B Containing Provisions on Dietary Fibre).
• Draft Advisory Lists of Nutrient Compounds for Use in Foods for Special
• Proposed Draft Recommendations on the Scientific Basis of Health Claims.
• Proposal for New Work to Amend the Codex General Principles for the Addition of Essential Nutrients to Foods (CAC/GL 09-1987).
• Proposal for New Work to Establish a Standard for Processed Cereal-based Foods for Underweight Infants and Young Children.
• Additional or Revised Nutrient Reference Values (NRVs) for Labelling Purposes; project document is available in Appendix VII of ALINORM 08/31/26.
The Fish and Fishery Products Committee is responsible for elaborating standards for fresh, frozen and otherwise processed fish, crustaceans, and molluscs. The Committee met on February 18-23, 2008 in Trondheim, Norway. The relevant document is ALINORM 08/31/18. The following items will be considered by the 31st Session of the Commission in June 2008.
To be considered at Step 8:
• Draft Code of Practice for Fish and Fishery Products (Live and Raw Bivalve Molluscs, Lobsters and Relevant Definitions).
• Draft Standard for Live and Raw Bivalve Molluscs.
The Committee will continue to work on:
• Draft Code of Practice for Fish and Fishery Products (Crabs and Relevant Definitions).
• Draft Standard for Sturgeon Caviar.
• Proposed Draft List of Methods for the Determination of Biotoxins in the Draft Standard for Raw and Live Bivalve Molluscs.
• Proposed Draft Code of Practice for Fish and Fishery Products (other sections).
• Proposed Draft Standard for Quick Frozen Scallop Adductor Muscle Meat.
• Proposed Draft Code of Practice on the Processing of Scallop Meat.
• Proposed Draft Standard for Smoked Fish, Smoke-Flavoured Fish and Smoke-Dried Fish.
• Revision of the Procedure for the Inclusion of Additional Species in Standards for Fish and Fishery Products.
• Proposed Draft Standard for Fish Sauce.
• Amendment to the Standard for Quick Frozen Fish Sticks (Nitrogen Factors).
• Proposed Draft Standard for Fresh/Live and Frozen Abalone.
The Codex Committee on Milk and Milk Products is responsible for establishing international codes and standards for milk and milk products. The Committee held its 8th Session February 4-8, 2008, in Queenstown, New Zealand. The relevant document is ALINORM 08/31/11. The following items will be considered by the 31st Session of the Commission in June 2008.
To be considered for adoption:
• Maximum levels for annatto extracts in Codex Standards for Milk and Milk Products, including consequential changes to the provision for beta carotene (vegetable).
• Food additive listings of the Standard for Fermented Milks.
• Methods of Analysis and Sampling for Milk and Milk Products Standards.
At Step 8:
• Draft Model Export Certificate for Milk and Proposed Milk Products.
At Step 5/8:
• Proposed Draft Amendment to the List of Additives of the Codex Standard for Creams and Prepared Creams.
At Step 5:
• Proposed Draft Amendment to the Codex Standard for Fermented Milks pertaining to Drinks based on Fermented Milk .
• Proposed Draft Standard for Processed Cheese.
• Maximum levels for annatto extracts in Codex individual cheese standards.
• Methods of Analysis and Sampling for Milk and Milk Products Standards, including AOAC standards.
The Codex Committee on Fats and Oils is responsible for elaborating standards for fats and oils of animal, vegetable, and marine origin. The Committee will hold its 21st Session in Kota Kinabalu, Malaysia, on February 16-20, 2009. The Committee is working on:
• Proposed Draft List of Acceptable Previous Cargoes.
• Proposed Draft Criteria (Code of Practice for the Storage and Transport of Fats and Oils in Bulk).
• Proposed Draft Amendments to the Standard for Named Vegetable Oils: Total carotenoids in unbleached palm oil.
• Proposed Draft Amendment to the Standard for Olive Oils and Olive Pomace Oils: Linolenic acid.
• Proposed Draft Amendments to the Standard for Named Vegetable Oils: Inclusion of palm kernel olein and palm kernel stearin.
The Codex Committee on Processed Fruits and Vegetables is responsible for elaborating standards for processed fruits and vegetables. The Committee will hold its 24th Session in Washington, DC, on September 15-19, 2008. The Committee is working on:
• Proposed Draft Codex Standard for Jams, Jellies and Marmalades.
• Proposed Draft Codex Standard for Certain Canned Vegetables.
• Proposed draft annexes specific to the draft Codex Standard for certain canned vegetables (proposed draft for Codex Standard for Certain Canned Vegetables).
• Project Document on Sampling Plan Including Metrological Provisions for Controlling Minimum Drained Weight of Canned Fruits and Vegetables.
• Proposed Layout for Codex Standards for Processed Fruits and Vegetables.
• Proposals for Amendments to the Priority List for Standardization of Processed Fruits and Vegetables.
• Methods of Analysis for Processed Fruits and Vegetables—Aqueous Coconut Products.
• Food Additives Provisions for Processed Fruits and Vegetables.
The Codex Committee on Natural Mineral Waters is responsible for elaborating standards for all types of natural mineral water products. The Committee was reactivated by the 30th Session of the Codex Alimentarius Commission to address discrepancies of the health-related limits of certain substances between the Codex Standard for Natural Mineral Waters (CODEX STAN 108-1981) and the current version of the WHO Guidelines for
To be considered at Step 5/8:
• Proposed Draft Amendment to Sections 3.2 and 6.3.2 of the Codex Standard for Natural Mineral Waters (CODEX STAN 108-1981).
Several Codex Alimentarius Commodity Committees have adjourned
The
To be considered for approval:
• Proposed Amendments to the Terms of Reference of the Codex
The Committee will continue to work on:
• Proposed Draft Risk Assessment Guidance Regarding Foodborne Antimicrobial Resistant Microorganisms.
• Proposed Draft Risk Management Guidance to Contain Foodborne Antimicrobial Resistant Microorganisms.
• Proposed Draft Guidance on Creating Risk Profiles for Antimicrobial Resistant Foodborne Microoganisms for Setting Risk Assessment and Management Priorities.
The Commission established this task force to develop standards, guidelines, or recommendations, as appropriate, for foods derived from biotechnology or traits introduced into foods by biotechnology, on the basis of scientific evidence, risk analysis and having regard, where appropriate, to other legitimate factors relevant to the health of consumers and the promotion of fair trade practices. The Task Force, established by the 23rd Session of the Codex Alimentarius Commission for a four-year period of time, completed its work, but was re-established at the 27th Session of the Commission. The relevant document is ALINORM 08/31/34. The Committee held its 7th Session in Chiba, Japan, September 24-28, 2007. The following are to be considered at Step 5/8 by the Commission at its 31st Session in June 2008.
• Proposed Draft Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Animals.
• Proposed Draft Annex: Food Safety Assessment of Foods Derived from Recombinant-DNA Plants Modified for Nutritional or Health Benefits.
• Proposed Draft Annex: Food Safety Assessment in Situations of Low-level Presence of Recombinant-DNA Plant Material in Foods.
The
To be considered at Step 5/8:
• Proposed draft Recommended International Code of Practice for the Processing and Handling of Quick Frozen Foods.
The Codex Alimentarius Commission is made up of an Executive Committee, as well as approximately 30 subsidiary bodies. Included in these subsidiary bodies are coordinating committees for groups of countries located in proximity to each other who share common concerns. There are currently six Regional Coordinating Committees:
• Coordinating Committee for Africa.
• Coordinating Committee for Asia.
• Coordinating Committee for Europe.
• Coordinating Committee for Latin America and the Caribbean.
• Coordinating Committee for the Near East.
• Coordinating Committee for North America and the South-West Pacific.
The United States participates as an active member of the Coordinating Committee for North America and the South-West Pacific, and is informed of the other coordinating committees through meeting documents, final reports, and representation at meetings. Each regional committee:
• Defines the problems and needs of the region concerning food standards and food control;
• Promotes within the committee contacts for the mutual exchange of information on proposed regulatory initiatives and problems arising from
• Recommends to the Commission the development of world-wide standards for products of interest to the region, including products considered by the committee to have an international market potential in the future; and
• Serves a general coordinating role for the region and performs such other functions as may be entrusted to it by the Commission.
The Coordinating Committee (CCNASWP) is responsible for defining problems and needs concerning food standards and food control of all Codex member countries of the region. The next session of the committee is tentatively scheduled for October 27-30, 2008 in Tonga. Items on the agenda for the next meeting may include:
• Draft new Strategic Plan for CCNASWP.
• Report of the Electronic Working Group on Objective 6 of the Strategic Plan (on promoting the development of standards for food products produced in Pacific Island countries).
• Discussion Paper on the Development of a Standard for Kava.
• Discussion Paper on the Development of a Standard for Nonu (Noni) Products.
•
• Evaluation of the effectiveness of the Trust Fund for the participation of developing countries in Codex.
• Nomination of regional coordinator.
A member of the Steering Committee heads the delegation to meetings of the General Principles Committee.
Pacific Northwest Region, USDA Forest Service.
Notice of Meeting.
The Pacific Northwest Recreation Resource Advisory Committee (RAC) will meet in Portland, Oregon. The purpose of the meeting is to review and provide recommendations concerning recreation fee proposals for facilities and services offered on lands managed by the Forest Service and Bureau of Land Management in Oregon and Washington. Proposals for this meeting include the jurisdictions of the Bureau of Land Management Salem, Vail, and Spokane Districts, the Okanogan-Wenatchee, Olympic, Rogue River-Siskiyou, Umatilla, Wallowa-Whitman, and Willamette National Forests. Other items of interest related to the Federal Lands Recreation Enhancement Act of 2004 may be discussed.
The meeting will be held on June 26, 2008, from 8:15 a.m. to 5 p.m. and June 27, 2008, from 8:15 a.m. to 4:30 p.m. A public input time is provided at 9 a.m. on both days. Comments will be limited to three minutes per person. The Designated Federal Official has the discretion to adjourn the meeting early if business is completed.
The meeting will be at the Red Lion Hotel, located at 1021 NE Grand Ave., Portland, Oregon, 97232. Send written comments to Dan Harkenrider, Designated Federal Official for the Pacific Northwest Recreation RAC, Columbia River Gorge National Scenic Area, 902 Wasco Ave, Suite 200, Hood River, Oregon 97031, or
Dan Harkenrider, Designated Federal Official, Columbia River Gorge National Scenic Area, 902 Wasco Ave, Suite 200, Hood River, Oregon 97031, 541-308-1700.
The meeting is open to the public. The agenda for June 26, 2008, includes fee proposals from the Rogue River-Siskiyou, Wallowa Whitman, and Umatilla Forests and the Salem, Vail, and Spokane Districts of the Bureau of Land Management. The agenda for June 27, 2008, includes fee proposals from the Okanogan-Wenatchee, Olympic, and Willamette Forests. Individuals from the public will have the opportunity to address the Committee at 9 a.m. both days. Committee discussion is limited to Forest Service and Bureau of Land Management staff and Recreation Resource Advisory Committee members. However; persons who wish to bring recreation fee matters to the attention of the Committee may address the committee at 9 a.m. both days. The agenda and proposals can be found at
The Recreation RAC is authorized by the Federal Land Recreation Enhancement Act, which was signed into law by President Bush in December 2004.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a planning meeting of the Kansas Advisory Committee to the Commission will convene on Wednesday, July 23, 2008 at 1 p.m and adjourn at 3 p.m at the Ogletree, Deakins, Nash, Smoak, & Stewart Law Firm, 4717 Grand Avenue, Suite 300, Kansas City, MO 64108. The purpose of the meeting is to conduct orientation and program planning for future SAC activities.
Members of the public are entitled to submit written comments; the comments must be received in the Central Regional Office by July 8, 2008. The address is 400 State Avenue, Suite 908, Kansas City, Kansas 66101. Persons wishing to e-mail their comments, or to present their comments verbally at the meeting, or who desire additional information should contact Farella E. Robinson, Regional Director, Central Regional Office, at (913) 551-1400 or by e-mail
Hearing-impaired persons who will attend the meeting and require the services of a sign language interpreter should contact the Regional Office at least ten (10) working days before the scheduled date of the meeting.
Records generated from this meeting may be inspected and reproduced at the Central Regional Office, as they become available, both before and after the meeting. Persons interested in the work of the advisory committee are advised to go to the Commission's Web site,
The meetings will be conducted pursuant to the provisions of the rules and regulations of the Commission and FACA.
Import Administration, International Trade Administration, Department of Commerce.
On December 31, 2007, the Department of Commerce (the Department) published the preliminary results of the antidumping duty administrative review for certain hot-rolled carbon steel flat products from India.
Based on our analysis of the comments received, we have made changes to the margin calculations. Therefore, the final results differ from the preliminary results. The final weighted-average dumping margins for the reviewed firms are listed below in the section entitled “Final Results of Review.”
June 5, 2008.
Christopher Hargett (Ispat), Joy Zhang (Tata Steel), Stephanie Moore (JSW) or
On December 31, 2007, the Department published the
On April 4, 2008, United States Steel Corporation (U.S. Steel) and Nucor Corporation (Nucor) (collectively, petitioners) filed case briefs. On April 4, 2008, Essar and JSW filed case briefs. On April 11, 2008, petitioners filed rebuttal briefs. Also, on April 11, 2008, Ispat, Essar, JSW, and Tata filed rebuttal briefs.
On April 7, 2008, the Department published the notice of extension of final results of the antidumping administrative review of certain hot-rolled carbon steel flat products from India, extending the deadline for these final results to no later than May 14, 2008.
The merchandise subject to this order is hot-rolled carbon steel products of a rectangular shape, of a width of 0.5 inch or greater, neither clad, plated, nor coated with metal and whether or not painted, varnished, or coated with plastics or other non-metallic substances, in coils (whether or not in successively superimposed layers), regardless of thickness, and in straight lengths, of a thickness of less than 4.75 mm and of a width measuring at least 10 times the thickness. Universal mill plate (
Specifically included in the scope of this order are vacuum-degassed, fully stabilized (commonly referred to as interstitial-free (IF)) steels, high-strength low-alloy (HSLA) steels, and the substrate for motor lamination steels. IF steels are recognized as low-carbon steels with micro-alloying levels of elements such as titanium or niobium (also commonly referred to as columbium), or both, added to stabilize carbon and nitrogen elements. HSLA steels are recognized as steels with micro-alloying levels of elements such as chromium, copper, niobium, vanadium, and molybdenum. The substrate for motor lamination steels contains micro-alloying levels of elements such as silicon and aluminum.
Steel products included in the scope of this order, regardless of definitions in the Harmonized Tariff Schedule of the United States (HTS), are products in which: (i) iron predominates, by weight, over each of the other contained elements; (ii) the carbon content is 2 percent or less, by weight; and (iii) none of the elements listed below exceeds the quantity, by weight, respectively indicated:
All products that meet the physical and chemical description provided above are within the scope of this order unless otherwise excluded. The following products, by way of example, are outside or specifically excluded from the scope of this order:
• Alloy hot-rolled carbon steel products in which at least one of the chemical elements exceeds those listed above (including,
• Society of Automotive Engineers (SAE)/American Iron & Steel Institute (AISI) grades of series 2300 and higher.
• Ball bearings steels, as defined in the HTS.
• Tool steels, as defined in the HTS.
• Silico-manganese (as defined in the HTS) or silicon electrical steel with a silicon level exceeding 2.25 percent.
• ASTM specifications A710 and A736.
• United States Steel (USS) Abrasion-resistant steels (USS AR 400, USS AR 500).
• All products (proprietary or otherwise) based on an alloy ASTM specification (sample specifications: ASTM A506, A507).
• Non-rectangular shapes, not in coils, which are the result of having been processed by cutting or stamping and which have assumed the character of articles or products classified outside chapter 72 of the HTS.
The merchandise subject to this order is currently classifiable in the HTS at subheadings: 7208.10.15.00, 7208.10.30.00, 7208.10.60.00, 7208.25.30.00, 7208.25.60.00, 7208.26.00.30, 7208.26.00.60, 7208.27.00.30, 7208.27.00.60, 7208.36.00.30, 7208.36.00.60, 7208.37.00.30, 7208.37.00.60, 7208.38.00.15, 7208.38.00.30, 7208.38.00.90, 7208.39.00.15, 7208.39.00.30, 7208.39.00.90, 7208.40.60.30, 7208.40.60.60, 7208.53.00.00, 7208.54.00.00, 7208.90.00.00, 7211.14.00.90, 7211.19.15.00, 7211.19.20.00, 7211.19.30.00, 7211.19.45.00, 7211.19.60.00, 7211.19.75.30, 7211.19.75.60, and 7211.19.75.90. Certain hot-rolled carbon steel covered by this order, including: vacuum-degassed fully stabilized; high-strength low-alloy; and the substrate for motor lamination steel may also enter under the following tariff numbers: 7225.11.00.00, 7225.19.00.00, 7225.30.30.50, 7225.30.70.00, 7225.40.70.00, 7225.99.00.90, 7226.11.10.00, 7226.11.90.30, 7226.11.90.60, 7226.19.10.00, 7226.19.90.00, 7226.91.50.00, 7226.91.70.00, 7226.91.80.00, and 7226.99.00.00. Subject merchandise may also enter under 7210.70.30.00, 7210.90.90.00, 7211.14.00.30, 7212.40.10.00, 7212.40.50.00, and 7212.50.00.00. Although the HTS subheadings are provided for convenience and customs purposes, the Department's written description of the merchandise subject to this order is dispositive.
As stated in the
We continue to find that JSW is affiliated with the O.P. Jindal Group, but there still is no evidence on the record that indicates that any of the other companies in the group produces the subject merchandise at its own facility or could produce the merchandise without substantially retooling their facilities, or that any other company in the group besides JSW sells the subject merchandise.
Regarding JSW's affiliation with another steel company as alleged by Nucor, the Department preliminarily determined that the companies are not affiliated.
All issues raised in the case and rebuttal briefs by parties to this administrative review are addressed in the accompanying Issues and Decision Memorandum, which is hereby adopted by this notice. A list of the issues which parties have raised, and to which we have responded in the Issues and Decision Memorandum, is attached to this notice as an Appendix. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly on the Internet at
We determine that the following weighted-average margins exist:
The Department shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries. In accordance with 19 CFR 351.212(b)(1), where the rate is above
The Department clarified its “automatic assessment” regulation on May 6, 2003 (68 FR 23954). This clarification will apply to entries of subject merchandise during the POR produced by Tata, JSW, Ispat and Essar for which they did not know their merchandise was destined for the United States. In such instances, we will instruct CBP to liquidate any unreviewed entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction. For a full discussion of this clarification,
The following deposit requirements will be effective upon publication of this notice of final results of administrative review for all shipments of hot-rolled carbon steel flat products from India entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results, as provided by sections 751(a)(1) and (a)(2)(C) of the Act: (1) for companies covered by this review, the cash deposit rate will be the rate listed above; (2) for previously reviewed or investigated companies other than those covered by this review, the cash deposit rate will be the company-specific rate established for the most recent period; (3) if the exporter is not a firm covered in this review, a prior review, or the less-than-fair-value investigation, but the producer is, the cash deposit rate will be the rate established for the most recent period for the manufacturer of the subject merchandise; and (4) if neither the exporter nor the manufacturer has its own rate, the cash deposit rate will be 38.72 percent, the all-others rate published in the
This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping and/or countervailing duties prior to liquidation of the relevant entries during this period of review. Failure to comply with this requirement could result in the Department's presumption that reimbursement of antidumping and/or countervailing duties occurred and the subsequent assessment of doubled antidumping and or countervailing duties.
This notice also serves as a reminder to parties subject to administrative protective orders (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO as explained in the APO itself. See 19 CFR 351.305(a)(3). Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a sanctionable violation.
We are publishing these final results of administrative review and notice in accordance with sections 751(a)(1) and 777(i)(1) of the Act.
List of Comments in the Accompanying Issues and Decision Memorandum
Import Administration, International Trade Administration, Department of Commerce.
June 5, 2008.
Christopher Hargett, AD/CVD Operations, Office 3, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW., Washington, DC 20230, telephone: (202) 482-4161.
On October 31, 2007, the U.S. Department of Commerce (“Department”) published a notice of initiation of the administrative review of the antidumping duty order on certain lined paper products from the People's Republic of China, covering the period April 17, 2006 to August 31, 2007.
Section 751(a)(3)(A) of the Tariff Act of 1930, as amended (“the Act”), requires the Department to issue preliminary results within 245 days after the last day of the anniversary month of an order for which a review is requested. Section 751(a)(3)(A) of the Act further states that if it is not practicable to complete the review within the time period specified, the administering authority may extend the 245-day period to issue its preliminary results to up to 365 days.
We determine that completion of the preliminary results of this review within the 245-day period is not practicable for the following reasons. The mandatory respondent has complex cost allocation issues which require the Department to gather and analyze a significant amount of information associated with the factors of production and manufacturing costs. In addition, petitioner, Association of American School Paper Suppliers, has raised other issues which require the collection of additional information and has requested that the Department extend the preliminary results to allow more time to analyze these issues. Given the number and complexity of issues in this case and the Department's resource constraints, and in accordance with section 751(a)(3)(A) of the Act, we are extending the time period for issuing the preliminary results of review by 120 days. Therefore, the preliminary results are now due no later than September 29, 2008. The final results continue to be due 120 days after publication of the preliminary results.
This notice is issued and published pursuant to section 751(a)(3)(A) and 771(i)(1) of the Act.
Import Administration, International Trade Administration, Department of
June 5, 2008.
Erin Begnal or Toni Dach for the People’s Republic of China, Mike Heaney for Brazil, and Stephen Bailey for Thailand, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW, Washington, DC 20230; telephone: (202) 482-1442, (202) 482-1655, (202) 482-4475, and (202) 482-0193, respectively.
On October 18, 2007, the Department of Commerce (“Department”) initiated the antidumping duty investigations of polyethylene terephthalate film, sheet, and strip (“PET Film”) from the People’s Republic of China (“PRC”), Brazil, Thailand, and the United Arab Emirates (“UAE”).
Section 735(a)(2) of the Tariff Act of 1930 (“the Act”) provides that a final determination may be postponed until not later than 135 days after the date of the publication of the preliminary determination if, in the event of an affirmative determination, a request for such postponement is made by exporters who account for a significant proportion of exports of the subject merchandise, or in the event of a negative preliminary determination, a request for such postponement is made by petitioner. In addition, the Department’s regulations, at Section 351.210(e)(2), require that requests by respondents for postponement of a final determination be accompanied by a request for extension of provisional measures from a four-month period to not more than six months.
On May 2, 2008, DuPont Teijin Films China Limited, the sole active mandatory respondent in the PRC investigation, along with its affiliates DuPont Teijin Hongji Films Ningbo Co., Ltd., and DuPont-Hongji Films Foshan Co., Ltd., and Terphane Ltda., the sole mandatory respondent in the Brazil investigation, requested extension of the final determinations and extension of the provisional measures.
On May 2, 2008, DuPont Teijin Films, Mitsubishi Polyester Film of America, Inc., SKC, Inc. and Toray Plastics (America), Inc. (collectively, “petitioners”), requested an extension of the final determination in the Thailand investigation. Thus, as the request for extension in the Thailand investigation was made by petitioners because the preliminary determination in the Thailand investigation is negative, and no compelling reasons for denial exist, we are extending the due date for the final determination in the Thailand investigation to no later than 135 days after the date of the publication of the preliminary determination.
For the reasons identified above, we are postponing the final determinations in the PRC, Brazil, and Thailand investigations until September 17, 2008.
This notice is issued and published pursuant to sections 777(i) and 735(a)(2) of the Act and 19 CFR 351.210(g).
Import Administration, International Trade Administration, Department of Commerce.
Notice of Upcoming Sunset Reviews
Every five years, pursuant to section 751(c) of the Tariff Act of 1930, as amended, the Department of Commerce (“the Department”) and the International Trade Commission automatically initiate and conduct a review to determine whether revocation of a countervailing or antidumping duty order or termination of an investigation suspended under section 704 or 734 would be likely to lead to continuation or recurrence of dumping or a countervailable subsidy (as the case may be) and of material injury.
The following Sunset Reviews are scheduled for initiation in July 2008 and will appear in that month’s Notice of Initiation of Five-year Sunset Reviews.
The Department's procedures for the conduct of Sunset Reviews are set forth in 19 CFR 351.218. Guidance on methodological or analytical issues relevant to the Department's conduct of Sunset Reviews is set forth in the Department's Policy Bulletin 98.3--Policies Regarding the Conduct of Five-year (“Sunset”) Reviews of Antidumping and Countervailing Duty Orders; Policy Bulletin, 63 FR 18871 (April 16, 1998) . The Notice of Initiation of Five-year (“Sunset”) Reviews provides further information regarding what is required of all parties to participate in Sunset Reviews.
Pursuant to 19 CFR 351.103(c), the Department will maintain and make available a service list for these proceedings. To facilitate the timely preparation of the service list(s), it is requested that those seeking recognition as interested parties to a proceeding contact the Department in writing within 10 days of the publication of the Notice of Initiation.
Please note that if the Department receives a Notice of Intent to Participate from a member of the domestic industry within 15 days of the date of initiation, the review will continue. Thereafter, any interested party wishing to
This notice is not required by statute but is published as a service to the international trading community.
Import Administration, International Trade Administration, Department of Commerce.
The Department of Commerce (the “Department”) has determined that countervailable subsidies are being provided to producers and exporters of circular welded carbon quality steel pipe (“CWP”) from the People's Republic of China (“PRC”). For information on the estimated countervailing duty rates, please see the “Suspension of Liquidation” section, below.
June 5, 2008.
Shane Subler, Damian Felton or Salim Bhabhrawala, AD/CVD Operations, Office 1, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW, Washington, DC 20230; telephone: (202) 482-0189, (202) 482-0133 or (202) 482-1784 respectively.
The Petitioners in this investigation are the Ad Hoc Coalition for Fair Pipe Imports from the People's Republic of China and the United States Steel Workers (collectively, “Petitioners”).
The period for which we are measuring subsidies, or period of investigation, is January 1, 2006, through December 31, 2006.
The following events have occurred since the announcement of the preliminary determination published in the
On November 13, 2007, the Department issued questionnaires to Weifang East Steel Pipe Co., Ltd. (“East Pipe”); Zhejiang Kingland Pipeline and Technologies Co., Ltd., Kingland Group Co., Ltd., Beijing Kingland Century Technologies Co., Ltd., Zhejiang Kingland Pipeline Industry Co., Ltd., and Shanxi Kingland Pipeline Co., Ltd. (collectively, “Kingland”) and, the Government of the People's Republic of China (“GOC”) regarding new subsidy allegations made by petitioners on October 3, 2007. We received responses to these questionnaires from Kingland on November 22, 2007, and from the GOC and East Pipe on December 5, 2007.
We issued supplemental questionnaires to East Pipe and Kingland on November 16, 2007, and to the GOC on November 19, 2007. We received responses to these questionnaires from Kingland on December 4, 2007, from East Pipe on December 12, 2007, and from the GOC on December 17, 2007. We issued additional supplemental questionnaires to Kingland on December 14, 2007, and East Pipe on December 17, 2007. We received responses to these questionnaires from Kingland and East Pipe on December 27, 2007.
The GOC, East Pipe, Kingland, Petitioners, and interested parties also submitted factual information, comments, and arguments at numerous instances prior to the final determination based on various deadlines for submissions of factual information and/or arguments established by the Department subsequent to the
From January 14 through January 23, 2008, we conducted verification of the questionnaire responses submitted by the GOC, Kingland, and East Pipe.
On April 9, 2008, we issued our post-preliminary determination regarding the provision of land for less than adequate remuneration and new subsidy allegations. We addressed our preliminary findings in an April 9, 2008, memorandum to David M. Spooner, Assistant Secretary for Import Administration, entitled
We received case briefs from the GOC, East Pipe, Kingland, Petitioners, certain members of the Specialty Steel Industry of North America (“SSINA”), United States Steel Corporation (“US Steel”), Western International Forest Products, LLC (“Western”), MAN Ferrostaal, Inc., Commercial Metals Company and QT Trading LP (collectively, “MAN Ferrostaal”), and SeAH Steel America (“SSA”) on April 17, 2008. The same parties submitted rebuttal briefs on April 22 and April 29, 2008. We held a hearing for this investigation on May 5, 2008.
The scope of this investigation covers certain welded carbon quality steel pipes and tubes, of circular cross-section, and with an outside diameter of 0.372 inches (9.45 mm) or more, but not more than 16 inches (406.4 mm), whether or not stenciled, regardless of wall thickness, surface finish (
Specifically, the term “carbon quality” includes products in which (a) iron predominates, by weight, over each of the other contained elements; (b) the carbon content is 2 percent or less, by weight; and (c) none of the elements listed below exceeds the quantity, by weight, as indicated:
Standard pipe is made primarily to American Society for Testing and Materials (“ASTM”) specifications, but
The scope of this investigation does not include: (a) pipe suitable for use in boilers, superheaters, heat exchangers, condensers, refining furnaces and feedwater heaters, whether or not cold drawn; (b) mechanical tubing, whether or not cold-drawn; (c) finished electrical conduit; (d) finished scaffolding; (e) tube and pipe hollows for redrawing; (f) oil country tubular goods produced to API specifications; and (g) line pipe produced to only API specifications.
The pipe products that are the subject of this investigation are currently classifiable in HTSUS statistical reporting numbers 7306.30.10.00, 7306.30.50.25, 7306.30.50.32, 7306.30.50.40, 7306.30.50.55, 7306.30.50.85, 7306.30.50.90, 7306.50.10.00, 7306.50.50.50, 7306.50.50.70, 7306.19.10.10, 7306.19.10.50, 7306.19.51.10, and 7306.19.51.50. However, the product description, and not the Harmonized Tariff Schedule of the United States (“HTSUS”) classification, is dispositive of whether merchandise imported into the United States falls within the scope of the investigation.
The scope listed above has changed from the
On December 19, 2007, Petitioners requested that the Department clarify the scope of this investigation and the companion antidumping duty investigation of CWP from the PRC. We have analyzed the request and comments of the interested parties regarding the scope of this investigation. Our position on these comments is discussed in the final determination in the companion antidumping duty investigation of CWP from the PRC.
Because the PRC is a “Subsidies Agreement Country” within the meaning of section 701(b) of the Tariff Act of 1930, as amended, (the Act), section 701(a)(2) of the Act applies to this investigation. Accordingly, the ITC must determine whether imports of the subject merchandise from the PRC materially injure, or threaten material injury to a U.S. industry. On August 3, 2007, the ITC published its preliminary determination that there is a reasonable indication that an industry in the United States is materially injured or threatened with material injury by reason of imports from China of circular welded carbon-quality steel pipe. 72 FR 43295.
In the
All issues raised in the case and rebuttal briefs by parties to this investigation are addressed in the
Sections 776(a)(1) and (2) of the Act provide that the Department shall apply “facts otherwise available” if,
Where the Department determines that a response to a request for information does not comply with the request, section 782(d) of the Act provides that the Department will so inform the party submitting the response and will, to the extent practicable, provide that party the opportunity to remedy or explain the deficiency. If the party fails to remedy the deficiency within the applicable time limits and subject to section 782(e) of the Act, the Department may disregard all or part of the original and subsequent responses, as appropriate. Section 782(e) of the Act provides that the Department “shall not decline to consider information that is submitted by an interested party and is necessary to the determination but does not meet all applicable requirements established by the administering authority” if the information is timely, can be verified, is not so incomplete that it cannot be used, and if the interested party acted to the best of its ability in providing the information. Where all of these conditions are met, the statute requires the Department to use the information if it can do so without undue difficulties.
Section 776(b) of the Act further provides that the Department may use an adverse inference in applying the facts otherwise available when a party has failed to cooperate by not acting to the best of its ability to comply with a request for information. Section 776(b) of the Act also authorizes the Department to use as adverse facts available (“AFA”) information derived from the petition, the final determination, a previous
Section 776(c) of the Act provides that, when the Department relies on secondary information rather than on information obtained in the course of an investigation or review, it shall, to the extent practicable, corroborate that information from independent sources that are reasonably at its disposal. Secondary information is defined as “{i}nformation derived from the petition that gave rise to the investigation or review, the final determination concerning the subject merchandise, or any previous review under section 751 concerning the subject merchandise.”
The Department has concluded that it is appropriate to base the final determination for Tianjin Shuangjie Steel Pipe Group Co., Ltd. (“Shuangjie”) on facts otherwise available. Shuangjie failed to respond at all to the Department's October 24, 2007, request for shipment data relating to the allegation of critical circumstances, did not respond to the Department's October 25, 2007, supplemental questionnaire, and finally, on October 31, 2007, withdrew all of its proprietary information from the record.
Consequently, the use of facts otherwise available is warranted under section 776(a)(2)(A) of the Act.
In selecting from among the facts available, the Department has determined that an adverse inference is warranted, pursuant to section 776(b) of the Act because, in addition to not fully responding to all of our requests for information, Shuangjie withdrew from all participation in the investigation and did not provide the Department with the opportunity to verify the information it did submit. Thus, Shuangjie failed to cooperate by not acting to the best of its ability, and our final determination is based on total AFA.
We have also determined that it is appropriate to apply facts available with respect to certain information that the GOC failed to provide, or information that could not be verified. Specifically, despite the Department's requests to submit sub-national government plans relating to the steel industry in the PRC, the GOC stated that none existed. However, at verification the Department discovered the existence of the Shandong Provincial Steel Plan. Additionally, the Department was unable to verify information regarding the level of state ownership in the HRS industry in the PRC because the GOC misrepresented the source of the data. In both instances, the GOC failed to act to the best of its ability and, consequently, application of AFA is warranted.
In deciding which facts to use as AFA, section 776(b) of the Act and 19 CFR 351.308(c)(1) authorize the Department to rely on information derived from (1) the petition, (2) a final determination in the investigation, (3) any previous review or determination, or (4) any information placed on the record. It is the Department's practice to select, as AFA, the highest calculated rate in any segment of the proceeding.
The Department's practice when selecting an adverse rate from among the possible sources of information is to ensure that the margin is sufficiently adverse “as to effectuate the purpose of the facts available role to induce respondents to provide the Department with complete and accurate information in a timely manner.”
Therefore, for every program based on the provision of goods at less than adequate remuneration, the Department used the Kingland rate for the provision of hot-rolled steel for less than adequate remuneration. For value added tax (“VAT”) programs, we are unable to utilize company-specific rates from this proceeding because neither respondent received any countervailable subsidies from these subsidy programs. Therefore, for VAT programs we are also applying the highest subsidy rate for any program otherwise listed, which in this instance is Kingland's rate for the provision of hot-rolled steel for less than adequate remuneration.
Similarly, for the grant programs, we are not relying on the highest calculated final rate because it is
Finally, for the six alleged income tax programs pertaining to either the reduction of the income tax rates or exemption from income tax, we have applied an adverse inference that Shuangjie paid no income tax during the period of investigation (
In a change from the
We do not need to corroborate these rates because they are not considered secondary information as they are based on information obtained in the course of this investigation, pursuant to section 776(c) of the Act.
Regarding the application of adverse facts available to the GOC, we have treated companies as state-owned
In accordance with section 705(c)(1)(B)(i)(I) of the Act, we have calculated an individual rate for the companies under investigation, East Pipe, Kingland and Shuangjie. Section 705(c)(5)(A)(i) of the Act states that for companies not investigated, we will determine an “all others” rate equal to the weighted average countervailable subsidy rates established for exporters and producers individually investigated, excluding any zero and
Nothwithstanding the language of section 705(c)(1)(B)(i)(I) of the Act, we have not calculated the “all others” rate by weight averaging the rates of East Pipe and Kingland, because doing so risks disclosure of proprietary information. Therefore, we have calculated a simple average of the two responding firms' rates. Since there were either no or
Because we preliminarily determined that critical circumstances exist for entries of CWP manufactured/exported by Kingland, Shuangjie and “all other” Chinese manufacturers/exporters and pursuant to sections 703(d)(1)(B) and (2) and 703(e)(2)(A) of the Act, we instructed the U.S. Customs and Border Protection (“CBP”) to suspend liquidation of entries of CWP manufactured/exported by Kingland, Shuangjie and “all other” Chinese exports of CWP which were entered or withdrawn from warehouse, for consumption on or after November 13, 2007, and to apply the suspension of liquidation to any unliquidated entries entered, or withdrawn from warehouse for consumption, on or after August 15, 2007 (90 days before the date of publication of the
For entries of CWP manufactured/exported by East Pipe, we did not instruct CBP to suspend liquidation because we preliminarily determined that East Pipe did not receive any countervailable subsidies.
We will issue a countervailing duty order and reinstate the suspension of liquidation under section 706(a) of the Act (for all companies including East Pipe) if the International Trade Commission (“ITC”) issues a final affirmative injury determination, and will require a cash deposit of estimated countervailing duties for such entries of merchandise in the amounts indicated above. If the ITC determines that material injury, or threat of material injury, does not exist, this proceeding will be terminated and all estimated duties deposited or securities posted as a result of the suspension of liquidation will be refunded or canceled.
In accordance with section 705(d) of the Act, we will notify the ITC of our determination. In addition, we are making available to the ITC all non-privileged and non-proprietary information related to this investigation. We will allow the ITC access to all privileged and business proprietary information in our files, provided the ITC confirms that it will not disclose such information, either publicly or under an APO, without the written consent of the Assistant Secretary for Import Administration.
In the event that the ITC issues a final negative injury determination, this notice will serve as the only reminder to parties subject to an administrative protective order (“APO”) of their responsibility concerning the destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
This determination is published pursuant to sections 705(d) and 777(i) of the Act.
Import Administration, International Trade Administration, Department of Commerce.
June 5, 2008.
The Department of Commerce (“the Department”) has determined that circular welded carbon quality steel pipe (“CWP”) from the People's Republic of China (“PRC”) is being, or is likely to be, sold in the United States at less than fair value (“LTFV”) as provided in section 735 of the Tariff Act of 1930, as amended (“the Act”). The final dumping margins for this investigation are listed in the “Final Determination Margins” section below.
Thomas Martin or Maisha Cryor, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW, Washington, DC 20230; telephone: (202) 482-3936 or (202) 482-5831, respectively.
On January 15, 2008, the Department published in the
All issues raised in the case and rebuttal briefs by the parties to this investigation are addressed in the “Issues and Decision Memorandum for the Final Determination of Sales at Less than Fair Value: Circular Welded Carbon Quality Steel Pipe from the People's Republic of China,” dated concurrently with this notice, which is hereby adopted by this notice in its entirety (“Issues and Decision Memorandum”). A list of the issues which parties raised and to which we respond in the Issues and Decision Memorandum is attached to this notice as an Appendix. The Issues and Decision Memorandum is a public document and is on file in the Central Records Unit (“CRU”), Main Commerce Building, Room 1117, and is accessible on the Web at http://www.trade.gov/ia. The paper copy and electronic version of the memorandum are identical in content.
The period of investigation (“POI”) is October 1, 2006, through March 31, 2007.
Based on our analysis of comments received, we have made no changes in our margin calculations since the Department's
The scope of this investigation covers certain welded carbon quality steel pipes and tubes, of circular cross-section, and with an outside diameter of 0.372 inches (9.45 mm) or more, but not more than 16 inches (406.4 mm), whether or not stenciled, regardless of wall thickness, surface finish (
Specifically, the term “carbon quality” includes products in which (a) iron predominates, by weight, over each of the other contained elements; (b) the carbon content is 2 percent or less, by weight; and (c) none of the elements listed below exceeds the quantity, by weight, as indicated:
Standard pipe is made primarily to American Society for Testing and Materials (“ASTM”) specifications, but can be made to other specifications. Standard pipe is made primarily to ASTM specifications A-53, A-135, and A-795. Structural pipe is made primarily to ASTM specifications A-252 and A-500. Standard and structural pipe may also be produced to proprietary specifications rather than to industry specifications. This is often the case, for example, with fence tubing. Pipe multiple-stenciled to a standard and/or structural specification and to any other specification, such as the American Petroleum Institute (“API”) API-5L specification, is also covered by the scope of this investigation when it meets the physical description set forth above and also has one or more of the following characteristics: is 32 feet in length or less; is less than 2.0 inches (50 mm) in outside diameter; has a galvanized and/or painted surface finish; or has a threaded and/or coupled end finish. (The term “painted” does not include coatings to inhibit rust in transit, such as varnish, but includes coatings such as polyester.)
The scope of this investigation does not include: (a) pipe suitable for use in boilers, superheaters, heat exchangers, condensers, refining furnaces and feedwater heaters, whether or not cold drawn; (b) mechanical tubing, whether or not cold-drawn; (c) finished electrical conduit; (d) finished scaffolding; (e) tube and pipe hollows for redrawing; (f) oil country tubular goods produced to API specifications; and (g) line pipe produced to only API specifications.
The pipe products that are the subject of this investigation are currently classifiable in HTSUS statistical reporting numbers 7306.30.10.00, 7306.30.50.25, 7306.30.50.32, 7306.30.50.40, 7306.30.50.55, 7306.30.50.85, 7306.30.50.90, 7306.50.10.00, 7306.50.50.50, 7306.50.50.70, 7306.19.10.10, 7306.19.10.50, 7306.19.51.10, and 7306.19.51.50. However, the product description, and not the Harmonized Tariff Schedule of the United States (“HTSUS”) classification, is dispositive of whether merchandise imported into the United States falls within the scope of the investigation.
In its March case brief, Petitioners argued that the Department should revise; 1) the scope of the investigation to be based upon end-use application, and 2) the definition of “painted.” For the reasons discussed in the Issues and Decision Memorandum, we have not revised the scope of the investigation. However, we have revised the definition of the term “painted,” and have updated the scope accordingly.
In the
In proceedings involving NME countries, the Department begins with a rebuttable presumption that all companies within the country are subject to government control and, thus, should be assigned a single antidumping duty deposit rate. It is the Department's policy to assign all exporters of merchandise subject to an investigation in an NME country this single rate unless an exporter can demonstrate that it is sufficiently independent so as to be entitled to a separate rate.
In the
No party has commented on the eligibility of these companies for separate-rate status. For the final determination, we continue to find that the evidence placed on the record of this investigation by these companies demonstrates both a
We determined in the
In the
Section 776(b) of the Act provides that, in selecting from among the facts otherwise available, the Department may employ an adverse inference if an interested party fails to cooperate by not acting to the best of its ability to comply with requests for information.
Because we begin with the presumption that all companies within a NME country are subject to government control and because only the companies listed under the “Final Determination Margins” section below have overcome that presumption, we are applying a single antidumping rate (
In the
Section 776(c) of the Act provides that, when the Department relies on secondary information in using the facts otherwise available, it must, to the extent practicable, corroborate that information from independent sources that are reasonably at its disposal. We have interpreted “corroborate” to mean that we will, to the extent practicable, examine the reliability and relevance of the information submitted.
Because there are no cooperating mandatory respondents, to corroborate the 85.55 percent margin used as adverse facts available for the PRC-wide entity, we relied upon our pre-initiation analysis of the adequacy and accuracy of the information in the petition.
On December 11, 2007, the Department preliminarily found that critical circumstances existed for all PRC exporters of subject merchandise, including the separate rate applicant companies and companies subject to the PRC-wide rate. The Department affirmed this preliminary finding in the
Based on the comments from interested parties, we have revised our analysis, but continue to find that critical circumstances exist with regard
In
{w}hile continuing the practice of assigning separate rates only to exporters, all separate rates that the Department will now assign in its NME investigations will be specific to those producers that supplied the exporter during the period of investigation. Note, however, that one rate is calculated for the exporter and all of the producers which supplied subject merchandise to it during the period of investigation. This practice applies both to mandatory respondents receiving an individually calculated separate rate as well as the pool of non-investigated firms receiving the weighted-average of the individually calculated rates. This practice is referred to as the application of “combination rates” because such rates apply to specific combinations of exporters and one or more producers. The cash-deposit rate assigned to an exporter will apply only to merchandise both exported by the firm in question and produced by a firm that supplied the exporter during the period of investigation.
We determine that the following percentage weighted-average margins exist for the POI:
We will disclose the calculations performed within five days of the date of publication of this notice to parties in this proceeding in accordance with 19 CFR 351.224(b).
In accordance with section 735(c)(1)(B) of the Act, we are directing
In accordance with section 735(d) of the Act, we have notified the International Trade Commission (“ITC”) of our final determination of sales at LTFV. As our final determination is affirmative, in accordance with section 735(b)(2) of the Act, within 45 days the ITC will determine whether the domestic industry in the United States is materially injured, or threatened with material injury, by reason of imports or sales (or the likelihood of sales) for importation of the subject merchandise. If the ITC determines that material injury or threat of material injury does not exist, the proceeding will be terminated and all securities posted will be refunded or canceled. If the ITC determines that such injury does exist, the Department will issue an antidumping duty order directing CBP to assess, upon further instruction by the Department, antidumping duties on all imports of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the effective date of the suspension of liquidation.
This notice also serves as a reminder to the parties subject to administrative protective order (“APO”) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305. Timely notification of return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.
This determination is issued and published in accordance with sections 735(d) and 777(i)(1) of the Act.
Import Administration, International Trade Administration, Department of Commerce.
In accordance with section 751(c) of the Tariff Act of 1930, as amended (“the Act”), the Department of Commerce (“the Department”) is automatically initiating a five-year review (“Sunset Review”) of the antidumping duty orders listed below. The International Trade Commission (“the Commission”) is publishing concurrently with this notice its notice of
June 2, 2008.
The Department official identified in the
The Department's procedures for the conduct of Sunset Reviews are set forth in its Procedures for Conducting Five-Year (“Sunset”) Reviews of Antidumping and Countervailing
In accordance with 19 CFR 351.218(c), we are initiating the Sunset Review of the following antidumping duty orders:
As a courtesy, we are making information related to Sunset proceedings, including copies of the pertinent statute and Department's regulations, the Department schedule for Sunset Reviews, a listing of past revocations and continuations, and current service lists, available to the public on the Department's sunset Internet Web site at the following address: “
Pursuant to 19 CFR 351.103(c), the Department will maintain and make available a service list for this proceeding. To facilitate the timely preparation of the service list(s), it is requested that those seeking recognition as interested parties to a proceeding contact the Department in writing 10 days of the publication of the Notice of Initiation.
Because deadlines in Sunset Reviews can be very short, we urge interested parties to apply for access to proprietary information under administrative protective order (“APO”) immediately following publication in the
Domestic interested parties defined in section 771(9)(C), (D), (E), (F), and (G) of the Act and 19 CFR 351.102(b)) wishing to participate in this Sunset Review must respond not later than 15 days after the date of publication in the
If we receive an order-specific notice of intent to participate from a domestic interested party, the Department's regulations provide that all parties wishing to participate in the Sunset Review must file complete substantive responses not later than 30 days after the date of publication in the
This notice of initiation is being published in accordance with section 751(c) of the Act and 19 CFR 351.218(c).
Office of National Marine Sanctuaries (ONMS), National Ocean Service (NOS), National Oceanic and Atmospheric Administration, Department of Commerce (DCC).
Notice and request for applications.
The Gray's Reef National Marine Sanctuary (GRNMS or sanctuary) is seeking applicants for the following vacant seats on its Sanctuary Advisory Council (council) Charter/Commercial Fishing and University Education. Applicants are chosen based upon their particular expertise and experience in relation to the seat for which they are applying; community and professional affiliations; philosophy regarding the protection and management of marine resources; and possibly the length of residence in the area affected by the sanctuary. Applicants who are chosen as members should expect to serve three-year terms, pursuant to the council's Charter.
Applications are due by July 15, 2008.
Application kits may be obtained from Becky Shortland, Council Coordinator (
Becky Shortland, Council Coordinator (
The sanctuary advisory council was established in August 1999 to provide advice and recommendations on management and protection of the sanctuary. The advisory council, through its members, also serves as
16 U.S.C. Section 1431,
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public meeting.
The Caribbean Fishery Management Council will hold a meeting of its Annual Catch Limit Plan Development Group (ACLG)
The ACLG will meet on June 24-25, 2008.
The meeting will be held at the Best Western San Juan Airport Hotel and Casino, located at the Luis Munoz Marin Airport, in Carolina, Puerto Rico.
Caribbean Fishery Management Council, 268 Munoz Rivera Avenue, Suite 1108, San Juan, Puerto Rico 00918; telephone: (787) 766-5926.
The ACLG will meet to discuss the items contained in the following agenda:
•Call to Order
•Overview of ACLG (Annual Catch Limit Plan Development Group) Tasks
•Report from the Technical Monitoring and Compliance Team (TMCT) on:
-Fisheries Overfished and undergoing overfishing
-Other fisheries
•Determination of ACLs and AMs
-By Fishery (SFA Units: Groupers Unit 4, Parrotfishes, Queen Conch. etc.)
-By Species
-By Area
-By Gear
•Recommendations to the SSC
•Other Business
•Next Meeting
Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take final action to address the emergency.
The meeting is physically accessible to people with disabilities. For more information or request for sign language interpretation and/other auxiliary aids, please contact Mr. Miguel A. Rolon, Executive Director, Caribbean Fishery Management Council, 268 Munoz Rivera Avenue, Suite 1108, San Juan, Puerto Rico 00918, telephone (787) 766-5926, at least 5 days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public committee meeting.
The North Pacific Fishery Management Council's (Council) Crab Socioeconomic Data Collection Committee will meet in Anchorage, AK.
The meeting will be held on June 24, 2008, from 8 a.m. to 4:30 p.m.
The meeting will be held at Anchorage Hilton Hotel, Iliamna Room, 500 West 3rd Avenue, Anchorage, AK.
Mark Fina, NPFMC, telephone: (907) 271-2809.
The committee will have discussions concerning the collection of social and economic fisheries data, and potential analytical uses of those data. These data include revenue, cost, crew, labor, and community information, which may be collected from vessels and processing plants participating in the fisheries, as well as data from other sources.
Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take final action to address the emergency.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Gail Bendixen, (907) 271-2809, at least 5 working days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public meeting.
The Pacific Fishery Management Council's (Council) Groundfish Management Team (GMT) will hold a working meeting, which is open to the public.
The GMT meeting will be held Monday, June 23, 2008 from 1 p.m. until business for the day is completed. The GMT meeting will reconvene Tuesday, June 24 through Friday, June 27, from 8:30 a.m. until business for each day is completed.
The GMT meeting will be held at the Pacific Fishery Management
Mr. John DeVore, Groundfish Management Coordinator; telephone: (503) 820-2280.
The purpose of the GMT working meeting is to complete analyses for the 2009-10 Groundfish Harvest Specifications and Management Measures Environmental Impact Statement (EIS). The main task will be completing any analysis of the Council's preferred alternative for groundfish harvest specifications and management measures for the next biennium.
Although non-emergency issues not contained in the meeting agenda may come before the GMT for discussion, those issues may not be the subject of formal GMT action during this meeting. GMT action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under Section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the GMT's intent to take final action to address the emergency.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Ms. Carolyn Porter at (503) 820-2280 at least 5 days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; request for nominations.
Nominations are being sought for appointment by the Secretary of Commerce (Secretary) to serve on the Marine Fisheries Advisory Committee (MAFAC or Committee) beginning in October 2008. MAFAC is the only Federal advisory committee with the responsibility to advise the Secretary on all matters concerning living marine resources that are the responsibility of the Department of Commerce. The Committee makes recommendations to the Secretary to assist in the development and implementation of Departmental regulations, policies and programs critical to the mission and goals of the NMFS. Nominations are encouraged from all interested parties involved with or representing interests affected by NMFS actions in managing living marine resources. Nominees should possess demonstrable expertise in a field related to the management of living marine resources and be able to fulfill the time commitments required for two annual meetings. Individuals serve for a term of three years for no more than two consecutive terms if re-appointed. NMFS is seeking qualified nominees to fill upcoming vacancies being created by the expiration of existing appointments this October, thereby bringing the Committee to its full complement of 21 members.
Nominations must be received by July 21, 2008.
Nominations must be sent to Dr. Mark Holliday, Executive Director, MAFAC, Office of Policy, NMFS F-14451, 1315 East-West Highway, Silver Spring, MD 20910.
Mark Holliday, MAFAC Executive Director; (301) 713-2239 x120; e-mail:
The establishment of MAFAC was approved by the Secretary on December 28, 1970, and subsequently chartered under the Federal Advisory Committee Act, 5 U.S.C. App. 2, on February 17, 1971. The Committee meets twice a year with supplementary subcommittee meetings as determined necessary by the Committee Chairperson. No less that 15 and no more than 21 individuals may serve on the Committee. Membership is comprised of highly qualified individuals representing commercial and recreational fisheries interests, environmental organizations, academic institutions, governmental, tribal and consumer groups from a balance of U.S. geographical regions, including Puerto Rico and the Western Pacific and the U.S. Virgin Islands.
A MAFAC member cannot be a Federal employee or a member of a Regional Fishery Management Council. Selected candidates must pass security checks and submit financial disclosure forms. Membership is voluntary, and except for reimbursable travel and related expenses, service is without pay.
Each submission should include the submitting person or organization's name and affiliation, a cover letter describing the nominee's qualifications and interest in serving on the Committee, a curriculum vitae and or resume of the nominee, and no more than three supporting letters describing the nominee's qualifications and interest in serving on the Committee. Self-nominations are acceptable. The following contact information must accompany each nominee's submission: name, address, phone number, fax number, and e-mail address (if available).
Nominations should be sent to (see
Estuarine Reserves Division, Office of Ocean and Coastal Resource Management, National Ocean Service, National Oceanic and Atmospheric Administration, U.S. Department of Commerce.
Notice of public comment period for the Revised Management Plan for the Sapelo Island National Estuarine Research Reserve.
Notice is hereby given that the Estuarine Reserves Division, Office of Ocean and Coastal Resource Management, National Ocean Service, National Oceanic and Atmospheric Administration (NOAA), U.S. Department of Commerce is announcing a thirty-day public comment period on the Sapelo Island National Estuarine Research Reserve Management Plan Revision.
The Sapelo Island Reserve (Georgia) was designated in 1976 pursuant to Section 315 of the Coastal Zone
The mission of the Sapelo Island Reserve is to perpetuate the protection of the Sapelo Island National Estuarine Research Reserve and to provide a platform for conservation-based research, education and stewardship through the Reserve. The revised management plan identifies priority resource issues that are addressed through active management. These priority issues include addressing public access and visitor impact on Reserve uplands and marsh areas, addressing impacts related to activities on the Reserve by the island's population and addressing the projected increase in development and population growth on the Georgia coast. By addressing these priority resource issues, the Sapelo Island Reserve aims to fulfill its mission.
The revised plan establishes goals and objectives for the Reserve's various programmatic activities, including scientific biological research; water quality monitoring; education, training, and outreach programs; and stewardship programs. It also outlines the plans for future facility development to support reserve operations.
Since 1999, the reserve has realized some aspects of the 1999 plan, including the contributions toward the completion of the Barrier Island Research and Learning Center, a joint research dormitory and lab shared with the University of Georgia.
Amy N. Clark at (301) 563-1137 or Laurie McGilvray at (301) 563-1158 of NOAA's National Ocean Service, Estuarine Reserves Division, 1305 East-West Highway, N/ORM5, 10th floor, Silver Spring, MD 20910. For copies of the revised Management Plan for the Sapelo Island National Estuarine Research Reserve visit
United States Patent and Trademark Office, Commerce.
Notice of proposed new Privacy Act system of records.
In accordance with the requirements of the Privacy Act of 1974, as amended, the United States Patent and Trademark Office (USPTO) gives notice of a proposed new system of records entitled “COMMERCE/PAT-TM-22 Patent e-Commerce Database.” We invite the public to comment on the system announced in this publication.
Written comments must be received no later than July 7, 2008. The amendments will become effective as proposed on July 7, 2008, unless the USPTO receives comments that would result in a contrary determination.
You may submit written comments by any of the following methods:
All comments received will be available for public inspection at the Federal rulemaking portal located at
Susan K. Fawcett, Records Officer, Office of the Chief Information Officer, Customer Information Services Group, Public Information Services Division, United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450, (571) 272-5429.
The United States Patent and Trademark Office (USPTO) is giving notice of a new system of records that is subject to the Privacy Act of 1974. The information in this system of records is used to maintain a list of customers who wish to receive patent e-Commerce updates or attend patent e-Commerce events.
The proposed new system of records, “COMMERCE/PAT-TM-22 Patent e-Commerce Database,” is published in its entirety below.
Patent e-Commerce Database.
Unclassified.
Search and Information Resources Administration (SIRA), United States Patent and Trademark Office, 600 Dulany Street, Alexandria, VA 22314.
Individuals subscribing to receive patent e-Commerce updates or to attend a patent e-Commerce event.
Name of subscriber, name of organization, and subscriber's electronic mail address.
35 U.S.C. 2.
The information in this system of records is used to maintain a list of customers who wish to receive patent e-Commerce updates or attend patent e-Commerce events.
See Prefatory Statement of General Routine Uses Nos. 4-5, 9-10, and 13, as found at 46 FR 63501-63502 (December 31, 1981). The USPTO may use the information contained in this system of records to contact customers who have expressed an interest in patent e-Commerce events and updates.
Not applicable.
Electronic records in a computer database stored on magnetic storage media.
Name of subscriber (first and/or last), name of organization, and subscriber's electronic mail address.
The database is password-protected and can only be accessed by authorized personnel.
Records retention and disposal is in accordance with the series records schedules.
SIRA Customer Outreach Manager, United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450.
Information about the records contained in this system may be obtained by sending a request in writing, signed, to the SIRA Customer Outreach Manager at the address above. When requesting notification of or access to records covered by this notice, requesters should provide their name and electronic mail address in accordance with the inquiry provisions appearing in 37 CFR 102 subpart B.
Requests from individuals should be addressed to the SIRA Customer Outreach Manager at the address above.
The general provisions for access, contesting contents, and appealing initial determinations by the individual concerned appear in 37 CFR 102 subpart B. Requests from individuals should be addressed to the SIRA Customer Outreach Manager at the address above.
Subject individuals and those authorized by the individual to furnish information.
None.
Commodity Futures Trading Commission.
Final order.
The Commodity Futures Trading Commission (Commission or CFTC) is exempting certain transactions in physically delivered futures contracts based on SPDR
Effective June 5, 2008.
Bruce Fekrat, Special Counsel, Office of the Director (telephone 202.418.5578, e-mail
In correspondence dated October 26, 2007, OneChicago, LLC (OneChicago or the Exchange),
On March 14, 2008, the Commission published for pubic comment in the
In accordance with the Memorandum of Understanding entered into between the CFTC and the SEC on March 11, 2008, and in particular the addendum thereto concerning
In order to promote responsible economic or financial innovation and fair competition, the Commission by rule, regulation, or order, after notice and opportunity for hearing, may (on its own initiative or on application of any person, including any board of trade designated or registered as a contract market or derivatives transaction execution facility for transactions for future delivery in any commodity under section 7 of this title) exempt any agreement, contract, or transaction (or class thereof) that is otherwise subject to subsection (a) of this section (including any person or class of persons offering, entering into, rendering advice or rendering other services with respect to, the agreement, contract, or transaction), either unconditionally or on stated terms or conditions or for stated periods and either retroactively or prospectively, or both, from any of the requirements of subsection (a) of this section, or from any other provision of this chapter (except subparagraphs (c)(ii) and (D) of section 2(a)(1) of this title, except that the Commission and the Securities and Exchange Commission may by rule, regulation, or order jointly exclude any agreement, contract, or transaction from section 2(a)(1)(D) of this title), if the Commission determines that the exemption would be consistent with the public interest.
The Commission shall not grant any exemption under paragraph (1) from any of the requirements of subsection (a) of this section unless the Commission determines that—
(A) The requirement should not be applied to the agreement, contract, or transaction for which the exemption is sought and that the exemption would be consistent with the public interest and the purposes of this Act; and
(B) The agreement, contract, or transaction—
(i) Will be entered into solely between appropriate persons; and
(ii) Will not have a material adverse effect on the ability of the Commission or any contract market or derivatives transaction execution facility to discharge its regulatory or self-regulatory duties under this Act.
In enacting Section 4(c) of the Act, Congress noted that the goal of the provision “is to give the Commission a means of providing certainty and stability to existing and emerging markets so that financial innovation and market development can proceed in an effective and competitive manner.”
This Order is subject to termination or revision, on a prospective basis, if the Commission determines upon further information that this exemption is not consistent with the public interest. If the Commission believes such exemption becomes detrimental to the public interest, the Commission may revoke this Order on its own motion.
The Paperwork Reduction Act of 1995 (PRA)
Section 15(a) of the CEA, as amended by Section 119 of the Commodity Futures Modernization Act of 2000,
In the Proposed Order, the Commission analyzed the costs and benefits associated with the implementation of an exemption under Section 4(c) of the Act. The Commission invited public comment on its analysis of the costs and benefits associated with the issuance of an exemptive order under Section 4(c) of the Act.
After considering the factors presented in this release, the Commission has determined to issue this Order.
Commodity Futures Trading Commission.
Final Order.
On April 23rd, 2008, the Commodity Futures Trading Commission (“CFTC” or the “Commission”) published for public comment in the
Robert B. Wasserman, Associate Director, 202-418-5092,
The OCC is both a Derivatives Clearing Organization (“DCO”) registered pursuant to Section 5b of the CEA,
OCC filed with the CFTC, pursuant to Section 5c(c) of the CEA and Commission Regulations 39.4(a) and 40.5 thereunder,
Section 4(c)(1) of the CEA empowers the CFTC to “promote responsible economic or financial innovation and fair competition” by exempting any transaction or class of transactions from any of the provisions of the CEA (subject to exceptions not relevant here) where the Commission determines that the exemption would be consistent with the public interest. The Commission may grant such an exemption by rule, regulation or order, after notice and opportunity for hearing, and may do so on application of any person or on its own initiative.
In enacting Section 4(c), Congress noted that the goal of the provision “is to give the Commission a means of providing certainty and stability to existing and emerging markets so that financial innovation and market development can proceed in an effective and competitive manner.”
ST Gold Options are novel instruments and, given their potential usefulness to the market, the Commission believes that this is an appropriate case for issuing an exemption without making a finding as to the nature of these particular instruments.
Section 4(c)(2) provides that the Commission may grant exemptions only when it determines that the requirements for which an exemption is being provided should not be applied to the agreements, contracts or transactions at issue, and the exemption is consistent with the public interest and the purposes of the CEA; that the agreements, contracts or transactions will be entered into solely between appropriate persons; and that the exemption will not have a material adverse effect on the ability of the Commission or any contract market or derivatives transaction execution facility to discharge its regulatory or self-regulatory responsibilities under the CEA.
In the April 23, 2008
After considering the complete record in this matter, the Commission has determined that the requirements of Section 4(c) have been met. First, the exemption is consistent with the public interest and with the purposes of the CEA, including “promot[ing] responsible innovation and fair competition among boards of trade, other markets and market participants.”
Second, the ST Gold Options will be entered into solely between appropriate persons. Section 4(c)(3) includes within the term “appropriate persons” a number of specified categories of persons, but also in subparagraph (K), “such other persons that the Commission determines to be appropriate in light of * * * the applicability of appropriate regulatory protections.” National securities exchanges, OCC and broker-dealers who will intermediate transactions in ST Gold Options are subject to extensive and detailed oversight by the SEC and, in the case of the intermediaries, the securities self-regulatory organizations. Given that the products will be traded on national securities exchanges, the regulatory protections available under the securities laws, and the goal of promoting fair competition, the ST Gold Options will be traded by appropriate persons.
Third, the exemption would not have a material adverse effect on the ability of the Commission or any designated contract market to carry out their regulatory responsibilities under the CEA. There is no reason to believe that granting an exemption here would interfere with the Commission's or a designated contract market's ability to oversee the trading of similar products or otherwise carry out their duties.
Therefore, upon due consideration, pursuant to its authority under Section 4(c) of the CEA, the Commission hereby issues this Order and exempts the trading of ST Gold Options on national securities exchanges and clearing of ST Gold Options by OCC in its capacity as a registered securities clearing agency from the CEA and the Commission's Regulations thereunder to the extent necessary to permit them to be so traded and cleared.
This Order is subject to termination or revision, on a prospective basis, if the Commission determines upon further information that this exemption is not consistent with the public interest. If the Commission believes such exemption becomes detrimental to the public interest, the Commission may revoke this Order on its own motion.
The Paperwork Reduction Act of 1995 (“PRA”)
Section 15(a) of the CEA, as amended by Section 119 of the Commodity Futures Modernization Act of 2000 (“CFMA”),
Section 15(a) of the CEA further specifies that costs and benefits shall be evaluated in light of five broad areas of market and public concern: protection of market participants and the public; efficiency, competitiveness, and financial integrity of futures markets; price discovery; sound risk management practices; and other public interest considerations. Accordingly, the Commission could in its discretion give greater weight to any one of the five enumerated areas and could in its discretion determine that, notwithstanding its costs, a particular order was necessary or appropriate to protect the public interest or to effectuate any of the provisions or to accomplish any of the purposes of the CEA.
The Commission has considered the costs and benefits of the order in light of the specific provisions of Section 15(a) of the CEA, as follows:
1.
2.
3.
4.
5.
The Commission requested comment on its application of these factors in the proposing release. No comments were received.
After considering these factors, the Commission has determined to issue this Order.
I applaud the agencies' efforts today to enhance cooperation and coordination in approving innovative and novel products. I respectfully dissent, however, from the Commission's issuance of the above-referenced order. In the promulgation of such an exemptive order in furtherance of the approval process, I believe the Commission should have adequate basis
Department of Defense, Defense Security Cooperation Agency.
Notice.
The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated 21 July 1996.
Ms. B. English, DSCA/DBO/CFM, (703) 601-3740.
The following is a copy of a letter to the Speaker of the House of Representatives, Transmittals 08-55 with attached transmittal, policy justification, and Sensitivity of Technology.
Department of Defense, Defense Security Cooperation Agency.
Notice.
The Department of Defense is publishing the unclassified text of a section 36(b)(l) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated 21 July 1996.
Ms. B. English, DSCA/DBO/CFM, (703) 601-3740.
The following is a copy of a letter to the Speaker of the House of Representatives, Transmittals 08-61 with attached transmittal, policy justification, and Sensitivity of Technology.
National Security Agency/Central Security Service, DoD.
Notice to Amend a System of Records.
The National Security Agency/Central Security Service proposes to amend a system of records notice in its existing inventory of record systems subject to the Privacy Act of 1974, (5 U.S.C. 552a), as amended.
This proposed action would be effective without further notice on July 7, 2008 unless comments are received which result in a contrary determination.
Send comments to the National Security Agency/ Central Security Service, Office of Policy, 9800 Savage Road, Suite 6248, Ft. George G. Meade, MD 20755-6248.
Ms. Anne Hill at (301) 688-6527.
The National Security Agency's systems of records notices subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended, have been published in the
The specific changes to the record system being amended is set forth below followed by the notice, as amended, published in its entirety. The proposed amendments are not within the purview of subsection (r) of the Privacy Act of 1974, (5 U.S.C. 552a), as amended, which requires the submission of a new or altered system report.
NSA/CSS Applicants (February 22, 1993, 58 FR 10531).
Delete and replace with “National Security Agency Act of 1959, 50 U.S.C. 402 note (Pub. L. 86-36); 5 U.S.C. Chapters 3 and 33; EO 10450, as amended and EO 9397 (SSN).”
Replace last item with “The DoD ‘Blanket Routine Uses’ published at the beginning of the NSA/CSS’ compilation
Delete entry and replace with “Paper in file folders and electronic storage media.”
Delete entry and replace with “Buildings are secured by a series of guarded pedestrian gates and checkpoints. Access to facilities is limited to security-cleared personnel and escorted visitors only. Within the facilities themselves, access to paper and computer printouts are controlled by limited-access facilities and lockable containers. Access to electronic means is limited and controlled by computer password protection.”
Delete entry and replace with “The Associate Director, Human Resources, National Security Agency/Central Security Service, Ft. George G. Meade, MD 20755-6000.”
Delete entry and replace with “Individuals seeking to determine whether information about themselves is contained in this system should address written inquiries to the National Security Agency/Central Security Service, Freedom of Information Act/Privacy Act Office, 9800 Savage Road, Ft. George G. Meade, MD 20755-6000.”
Delete entry and replace with “Individuals seeking access to information about themselves contained in this system should address written inquiries to the National Security Agency/Central Security Service, Freedom of Information Act/Privacy Act Office, 9800 Savage Road, Ft. George G. Meade, MD 20755-6000.”
Delete entry and replace with “The NSA/CSS rules for contesting contents and appealing initial determinations are published at 32 CFR Part 322 or may be obtained by written request addressed to the National Security Agency/Central Security Service, Freedom of Information Act/Privacy Act Office, 9800 Savage Road, Ft. George G. Meade, MD 20755-6000.”
NSA/CSS Applicants.
National Security Agency/Central Security Service, Ft. George G. Meade, MD 20755-6000.
Applicants for employment with NSA/CSS.
File contains forms, documents and correspondence providing personal and qualifications information submitted by individual applicants, educational institutions, past employers, references. Records include processing items, status reports, test results, interview reports, reports of reviewing organizations and other related information.
National Security Agency Act of 1959, 50 U.S.C. 402 note (Pub. L. 86-36); 5 U.S.C. Chapters 3 and 33; EO 10450, as amended and EO 9397 (SSN).
To support the recruitment, selection, hire and placement of applicants. The file is used to document applicant processing, as a basis for selection decisions by individual agency elements and the personnel organization, and such other related uses as required.
In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act, these records or information contained therein may specifically be disclosed outside the DoD as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:
To contractor employees and other government entities to make determinations as noted in the purpose above.
The DoD ‘Blanket Routine Uses’ published at the beginning of the NSA/CSS' compilation of system of record notices apply to this system.
Policies and practices for storing, retrieving, accessing, retaining, and disposing of records in the system:
Paper in file folders and electronic storage media.
By name, Social Security Number, and other appropriate data elements.
Buildings are secured by a series of guarded pedestrian gates and checkpoints. Access to facilities is limited to security-cleared personnel and escorted visitors only. Within the facilities themselves, access to paper and computer printouts are controlled by limited-access facilities and lockable containers. Access to electronic means is limited and controlled by computer password protection.
For applicants who are subsequently hired, records are transferred to Personnel File or destroyed as appropriate. For applicants not hired, record are retained for a period not to exceed one year or until completion of legal proceedings involving issues pertaining to these records, whichever is later, unless employment requirements necessitate retention for a longer period.
The Associate Director, Human Resources, National Security Agency/Central Security Service, Ft. George G. Meade, MD 20755-6000.
Individuals seeking to determine whether information about themselves is contained in this system should address written inquiries to the National Security Agency/Central Security Service, Freedom of Information Act/Privacy Act Office, 9800 Savage Road, Ft. George G. Meade, MD 20755-6000.
Individuals seeking access to information about themselves contained in this system should address written inquiries to the National Security Agency/Central Security Service, Freedom of Information Act/Privacy Act Office, 9800 Savage Road, Ft. George G. Meade, MD 20755-6000.
The NSA/CSS rules for contesting contents and appealing initial determinations are published at 32 CFR Part 322 or may be obtained by written request addressed to the National Security Agency/Central Security Service, Freedom of Information Act/Privacy Act Office, 9800 Savage Road, Ft. George G. Meade, MD 20755-6000.
Applicant, educational institutions, references, former employers including other governmental entities, interviewing and reviewing individuals including possible gaining organization, security and medical authorities and other sources as relevant and appropriate.
Portions of this system may be exempt pursuant to 5 U.S.C. 552a(k)(1) and (k)(5), as applicable.
An exemption rule for this record system has been promulgated according to the requirements of 5 U.S.C. 553(b)(1), (2), and (3), (c) and (e) and published in 32 CFR part 322. For additional information contact the system manager.
Office of the Secretary, DoD.
Notice to amend a system of records notice.
The Office of the Secretary of Defense is amending a system of records notice in its existing inventory of record systems subject to the Privacy Act of 1974, (5 U.S.C. 552a), as amended.
This proposed action will be effective without further notice on July 7, 2008 unless comments are received which result in a contrary determination.
Send comments to the Privacy Act Officer, Office of Freedom of Information, Washington Headquarters Services, 1155 Defense Pentagon, Washington, DC 20301-1155.
Mrs. Cindy Allard at (703) 588-2386.
The Office of the Secretary of Defense systems of records notices subject to the Privacy Act of 1974, (5 U.S.C. 552a), as amended, have been published in the
The specific changes to the record systems being amended are set forth below followed by the notice, as amended, published in its entirety. The proposed amendments are not within the purview of subsection (r) of the Privacy Act of 1974, (5 U.S.C. 552a), as amended, which requires the submission of a new or altered system report.
Defense Eligibility Records (February 11, 2008, FR 73 7716).
Delete DMDC 02 and replace with “DMDC 02 DoD.”
Delete entry and replace with “Defense Enrollment Eligibility Reporting System (DEERS).”
Defense Enrollment Eligibility Reporting System (DEERS).
EDS—Service Management Center, 1075 West Entrance Drive, Auburn Hills, MI 48326-2723.
Active duty members and other Uniform Servicemembers, i.e. Department of Defense (DoD), Coast Guard, NOAA and USPHS; Reserve Members; National Guard members; State National Guard Employees; Presidential Appointees of all Federal Government agencies; DoD and Uniformed Service civil service employees, except Presidential appointees; Disabled American veterans; DoD and Uniformed Service contract employees; Former members (Reserve service, discharged RR or SR following notification of retirement eligibility); Medal of Honor recipients; Non-DoD civil service employees; U.S. Military Academy Students; Non-appropriated fund DoD and Uniformed Service employees (NAF); Non-Federal Agency Civilian associates, i.e. American Red Cross Emergency Services paid employees, Non-DoD contract employees; Reserve retirees not yet eligible for retired pay; Retired military members eligible for retired pay; Foreign Affiliates; DoD OCONUS Hires; DoD Beneficiaries; Civilian Retirees; Dependents; Members of the general public treated for a medical emergency in a DoD Medical Facility; Emergency Contact Person; Care Givers; Prior Military Eligible for VA benefits.
Computer files containing beneficiary's name, Service or Social Security Number, enrollment number, relationship of beneficiary to sponsor, residence address of beneficiary or sponsor, date of birth of beneficiary, sex of beneficiary, branch of Service of sponsor, dates of beginning and ending eligibility, number of family members of sponsor, primary unit duty location of sponsor, race and ethnic origin of beneficiary, occupation of sponsor, rank/pay grade of sponsor, disability documentation, Medicare eligibility and enrollment data, primary and secondary fingerprints and photographs of beneficiaries, blood test results, dental care eligibility codes and dental x-rays.
Catastrophic Cap and Deductible (CCD) transactions, including monetary amounts; CHAMPUS/TRICARE claim records containing enrollee, participant and health care facility, provider data such as cause of treatment, amount of payment, name and Social Security or tax identification number of providers or potential providers of care; citizenship data/country of birth; civil service employee employment information (agency and bureau, pay plan and grade, nature of action code and nature of action effective date, occupation series, dates of promotion and expected return from overseas, service computation date); claims data; compensation data; contractor fee payment data; date of separation of former enlisted and officer personnel; demographic data (kept on others beyond beneficiaries) date of birth, home of record state, sex, race, education level; Department of Veterans Affairs disability payment records; digital signatures where appropriate to assert validity of data; email (home/work); emergency contact information; immunization data; Information Assurance (IA) Work Force information; language data; military personnel information (rank, assignment/deployment, length of service, military occupation, education, and benefit usage); pharmacy benefits; reason leaving military service or DoD civilian service; Reserve member's civilian occupation and employment information; education benefit eligibility and usage; special military pay information; SGLI/FGLI; stored documents for proofing identity and association; workforces information (e.g. Acquisition, First Responders); Privacy Act audit logs.
5 U.S.C. 301, Departmental Regulations; 10 U.S.C. Chapters 53, 54, 55, 58, and 75; 10 U.S.C. 136; 31 U.S.C.
The purpose of the system is to provide a database for determining eligibility to DoD entitlements and privileges; to support DoD health care management programs; to provide identification of deceased members; to record the issuance of DoD badges and identification cards, i.e. Common Access Cards (CAC) or beneficiary cards; and to detect fraud and abuse of the benefit programs by claimants and providers to include appropriate collection actions arising out of any debts incurred as a consequence of such programs.
To authenticate and identify DoD affiliated personnel (e.g., contractors); to assess manpower, support personnel and readiness functions; to perform statistical analyses; identify current DoD civilian and military personnel for purposes of detecting fraud and abuse of benefit programs; to register current DoD civilian and military personnel and their authorized dependents for purposes of obtaining medical examination, treatment or other benefits to which they are entitled; to ensure benefit eligibility is retained after separation from the military; information will be used by agency officials and employees, or authorized contractors, and other DoD Components for personnel and manpower studies; and to assist in recruiting prior-service personnel.
In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act, these records or information contained therein may specifically be disclosed outside the DoD as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:
1. To the Social Security Administration (SSA) to perform computer data matching against the SSA Wage and Earnings Record file for identifying employers of Department of Defense (DoD) beneficiaries eligible for health care. This employer data will in turn be used to identify those employed beneficiaries who have employment-related group health insurance, to coordinate insurance benefits provided by DoD with those provided by the other insurance. This information will also be used to perform computer data matching against the SSA Master Beneficiary Record file for identifying DoD beneficiaries eligible for health care who are enrolled in the Medicare Program, to coordinate insurance benefits provided by DoD with those provided by Medicare.
2. To other Federal agencies and state, local and territorial governments to identify fraud and abuse of the Federal agency's programs and to identify debtors and collect debts and overpayment in the DoD health care programs.
3. To each of the fifty states and the District of Columbia for the purpose of conducting an on going computer matching program with state Medicaid agencies to determine the extent to which state Medicaid beneficiaries may be eligible for Uniformed Services health care benefits, including CHAMPUS, TRICARE, and to recover Medicaid monies from the CHAMPUS program.
4. To provide dental care providers assurance of treatment eligibility.
5. To Federal agencies and/or their contractors, in response to their requests, for purposes of authenticating the identity of individuals who, incident to the conduct of official business, present the Common Access Card or similar identification as proof of identity to gain physical or logical access to government and contractor facilities, locations, networks, or systems.
6. To State and local child support enforcement agencies for purposes of providing information, consistent with the requirements of 29 U.S.C. 1169(a), 42 U.S.C. 666(a)(19), and E.O. 12953 and in response to a National Medical Support Notice (NMSN) (or equivalent notice if based upon the statutory authority for the NMSN), regarding the military status of identified individuals and whether, and for what period of time, the children of such individuals are or were eligible for DoD health care coverage.
7. To the Department of Health and Human Services (HHS):
a. For purposes of providing information, consistent with the requirements of 42 U.S.C. 653 and in response to an HHS request, regarding the military status of identified individuals and whether, and for what period of time, the children of such individuals are or were eligible for DoD healthcare coverage.
b. For purposes of providing information so that specified Medicare determinations, specifically late enrollment and waiver of penalty, can be made for eligible (1) DoD military retirees and (2) spouses (or former spouses) and/or dependents of either military retirees or active duty military personnel, pursuant to section 625 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2002 (as codified at 42 U.S.C. 1395p and 1395r).
c. To the Office of Child Support Enforcement, Federal Parent Locator Service, pursuant to 42 U.S.C. 653 and 653a; to assist in locating individuals for the purpose of establishing parentage; establishing, setting the amount of, modifying, or enforcing child support obligations; or enforcing child custody or visitation orders; the relationship to a child receiving benefits provided by a third party and the name and SSN of those third party providers who have a legal responsibility. Identifying delinquent obligors will allow State Child Support Enforcement agencies to commence wage withholding or other enforcement actions against the obligors.
8. To the American Red Cross for purposes of providing emergency notification and assistance to members of the Armed Forces, retirees, family members or survivors.
9. To the Department of Veterans Affairs (DVA):
a. To provide military personnel and pay data for present and former military personnel for the purpose of evaluating use of veterans' benefits, validating benefit eligibility and maintaining the health and well being of veterans and their family members.
b. To provide identifying military personnel data to the DVA and its insurance program contractor for the purpose of notifying separating eligible Reservists of their right to apply for Veteran's Group Life Insurance coverage
c. To register eligible veterans and their dependents for DVA programs.
d. Providing identification of former military personnel and survivor's financial benefit data to DVA for the purpose of identifying military retired pay and survivor benefit payments for use in the administration of the DVA's Compensation and Pension Program (38 U.S.C. 5106). The information is to be used to process all DVA award actions more efficiently, reduce subsequent overpayment collection actions, and minimize erroneous payments.
e. To conduct computer matching programs regulated by the Privacy Act of 1974, as amended (5 U.S.C. 552a), for the purposes of:
(1) Providing full identification of active duty military personnel, including full time National Guard/Reserve support personnel, for use in the administration of DVA's Compensation and Pension benefit program. The information is used to determine continued eligibility for DVA disability compensation to recipients who have returned to active duty so that benefits can be adjusted or terminated as required and steps taken by DVA to collect any resulting over payment (38 U.S.C. 5304(c)).
(2) Providing military personnel and financial data to the Veterans Benefits Administration, DVA for the purpose of determining initial eligibility and any changes in eligibility status to insure proper payment of benefits for GI Bill education and training benefits by the DVA under the Montgomery GI Bill (Title 10 U.S.C., Chapter 1606—Selected Reserve and Title 38 U.S.C., Chapter 30—Active Duty), the REAP educational benefit (Title 10 U.S.C, Chapter 1607), and the National Call to Service enlistment educational benefit (Title 10, Chapter 510). The administrative responsibilities designated to both agencies by the law require that data be exchanged in administering the programs.
(3) Providing identification of reserve duty, including full time support National Guard/Reserve military personnel, to the DVA, for the purpose of deducting reserve time served from any DVA disability compensation paid or waiver of VA benefit. The law (10 U.S.C. 12316) prohibits receipt of reserve pay and DVA compensation for the same time period, however, it does permit waiver of DVA compensation to draw reserve pay.
(4) Providing identification of former active duty military personnel who received separation payments to the DVA for the purpose of deducting such repayment from any DVA disability compensation paid. The law requires recoupment of severance payments before DVA disability compensation can be paid (10 U.S.C. 1174).
f. To provide identifying military personnel data to the DVA for the purpose of notifying such personnel of information relating to educational assistance as required by the Veterans Programs Enhancement Act of 1998 (38 U.S.C. 3011 and 3034).
10. To DoD Civilian Contractors and grantees for the purpose of performing research on manpower problems for statistical analyses.
11. To consumer reporting agencies to obtain current addresses of separated military personnel to notify them of potential benefits eligibility.
12. To Defense contractors to monitor the employment of former DoD employees and military members subject to the provisions of 41 U.S.C. 423.
13. To Federal and Quasi Federal agencies, territorial, state, and local governments to support personnel functions requiring data on prior military service credit for their employees or for job applications. To determine continued eligibility and help eliminate fraud and abuse in benefit programs and to collect debts and over payments owed to these programs. Information released includes name, Social Security Number, and military or civilian address of individuals. To detect fraud, waste and abuse pursuant to the authority contained in the Inspector General Act of 1978, as amended (Pub. L. 95-452) for the purpose of determining eligibility for, and/or continued compliance with, any Federal benefit program requirements.
14. To Federal and Quasi Federal agencies, territorial, state and local governments, and contractors and grantees for the purpose of supporting research studies concerned with the health and well being of active duty, reserve, and retired personnel or veterans, to include family members. DMDC will disclose information from this system of records for research purposes when DMDC:
a. Has determined that the use or disclosure does not violate legal or policy limitations under which the record was provided, collected, or obtained;
b. Has determined that the research purpose (1) cannot be reasonably accomplished unless the record is provided in individually identifiable form, and (2) warrants the risk to the privacy of the individual that additional exposure of the record might bring;
c. Has required the recipient to (1) Establish reasonable administrative, technical, and physical safeguards to prevent unauthorized use or disclosure of the record, and (2) remove or destroy the information that identifies the individual at the earliest time at which removal or destruction can be accomplished consistent with the purpose of the research project, unless the recipient has presented adequate justification of a research or health nature for retaining such information, and (3) make no further use or disclosure of the record except (A) In emergency circumstances affecting the health or safety of any individual, (B) for use in another research project, under these same conditions, and with written authorization of the Department, (C) for disclosure to a properly identified person for the purpose of an audit related to the research project, if information that would enable research subjects to be identified is removed or destroyed at the earliest opportunity consistent with the purpose of the audit, or (D) when required by law;
d. Has secured a written statement attesting to the recipients' understanding of, and willingness to abide by these provisions.
15. To Federal and State agencies for purposes of obtaining socioeconomic information on Armed Forces personnel so that analytical studies can be conducted with a view to assessing the present needs and future requirements of such personnel.
16. To Federal and state agencies to validate demographic data (e.g., Social Security Number, citizenship status, date and place of birth, etc.) for individuals in DoD personnel and pay files so that accurate information is available in support of DoD requirements.
17. To the Bureau of Citizenship and Immigration Services, Department of Homeland Security, for purposes of facilitating the verification of individuals who may be eligible for expedited naturalization (Pub. L. 108-136, Section 1701, and E.O. 13269, Expedited Naturalization).
18. To the Federal voting program to provide unit and e-mail addresses for the purpose of notifying the military members where to obtain absentee ballots.
19. To the Department of Homeland Security for the conduct of studies related to the health and well-being of Coast Guard members and to
20. To Coast Guard recruiters in the performance of their assigned duties.
21. To the Office of Personnel Management:
To conduct computer matching programs regulated by the Privacy Act of 1974, as amended (5 U.S.C. 552a), for the purpose of:
(1) Providing to OPM all reserve military members eligible for TRICARE Reserve Select (TRS) to matched against the OPM Central Personnel Data File (OPM/GOVT-1) for providing those reserve military members that are also Federal civil service employees. This disclosure by OPM will provide the DoD with the FEHB eligibility and Federal employment information necessary to determine continuing eligibility for the TRS program. Only those reservists not eligible for FEHB are eligible for TRS (Section 1076d of title 10).
The DoD “Blanket Routine Uses” published at the beginning of OSD's compilation of systems of records notices apply to this system.
Records are maintained on magnetic tapes and disks, and are housed in a controlled computer media library.
Records about individuals are retrieved by an algorithm which uses name, Social Security Number, date of birth, rank, and duty location as possible inputs. Retrievals are made on summary basis by geographic characteristics and location and demographic characteristics. Information about individuals will not be distinguishable in summary retrievals. Retrievals for the purposes of generating address lists for direct mail distribution may be made using selection criteria based on geographic and demographic keys.
Computerized records are maintained in a controlled area accessible only to authorized personnel. Entry to these areas is restricted to those personnel with a valid requirement and authorization to enter. Physical entry is restricted by the use of locks, guards, and administrative procedures (e.g., fire protection regulations).
Access to personal information is restricted to those who require the records in the performance of their official duties, and to the individuals who are the subjects of the record or their authorized representatives. Access to personal information is further restricted by the use of passwords, which are changed periodically. All individuals granted access to this system of records is to have received Information Assurance and Privacy Act training.
Data is destroyed when superseded or when no longer needed for operational purposes, whichever is later.
Deputy Director, Defense Manpower Data Center, DoD Center Monterey Bay, 400 Gigling Road, Seaside, CA 93955-6771.
Individuals seeking to determine whether information about themselves is contained in this system should address written inquiries to the Deputy Director, Defense Manpower Data Center, DoD Center Monterey Bay, 400 Gigling Road, Seaside, CA 93955-6771.
Written requests should contain the full name, Social Security Number (SSN), date of birth, and current address and telephone number of the individual.
Individuals should provide the name and number of this system of records notice so that your request can be tasked to the appropriate OSD/JS office. This section must also include a description of needed identifier so that the record may be retrieved.
Individuals seeking access to information about themselves contained in this system should address written inquiries to the OSD/JS FOIA Requester Service Center, Office of the Freedom of Information, Washington Headquarters Services, 1155 Defense Pentagon, Washington, DC 20301-1155.
Written requests should contain the full name, Social Security Number (SSN), date of birth, and current address and telephone number of the individual.
Individuals should provide the name and number of this system of records notice so that your request can be tasked to the appropriate OSD/JS office. This section must also include a description of needed identifier so that the record may be retrieved.
The OSD rules for accessing records, for contesting contents and appealing initial agency determinations are published in OSD Administrative Instruction 81; 32 CFR part 311; or may be obtained from the Privacy Act Officer, Office of Freedom of Information, Washington Headquarters Services, 1155 Defense Pentagon, Washington, DC 20301-1155.
Individuals, personnel, pay, and benefit systems of the military and civilian departments and agencies of the Defense Department, the Coast Guard, the Public Health Service, the National Oceanic and Atmospheric Administration, Department of Veterans Affairs, and other Federal agencies.
None.
Department of the Army, DoD.
Notice to Add a System of Records.
The Department of the Army is proposing to add a system of records to its existing inventory of records systems subject to the Privacy Act of 1974, (5 U.S.C. 552a), as amended.
The proposed action will be effective on July 7, 2008 unless comments are received that would result in a contrary determination.
Department of the Army, Freedom of Information/ Privacy Division, U.S. Army Records Management and Declassification Agency, 7701 Telegraph Road, Casey Building, Suite 144, Alexandria, VA 22325-3905.
Mr. Robert Dickerson at (703) 428-6513.
The Department of the Army systems of records notices subject to the Privacy Act of 1974, (5 U.S.C. 552a), as amended, have been published in the
The proposed system report, as required by 5 U.S.C. 552a(r) of the Privacy Act of 1974, as amended, was submitted on May 27, 2008, to the House Committee on Oversight and Government Reform, the Senate Committee on Homeland Security and Governmental Affairs, and the Office of Management and Budget (OMB) pursuant to paragraph 4c of Appendix I to OMB Circular No. A-130, “Federal Agency Responsibilities for Maintaining Records About Individuals,” dated
Combat-Related Special Compensation Files.
Combat-Related Special Compensation Branch, U.S. Army Human Resources Command, 200 Stovall Street, Alexandria, VA 22315.
Army Retirees who have applied for Combat-Related Special Compensation Program.
Full name, Social Security Number (SSN), military grade or rate, and claim number; DD Form 2860, Claim for Combat-Related Special Compensation (CRSC), may also contain: Medical reports and disability compensation information from the Department of Veterans Affairs; medical reports from civilian medical facilities; medical board reports; statements of findings of physical evaluation boards; military health records; military personnel records; records and reports from the Defense Finance and Accounting Service; retirement records; pay information; correspondences between applicants and agency; intra-agency and interagency correspondence concerning the case; members of Congress, attorneys, representatives, and other cognizant persons or parties; decisional documents; any additional supporting documentation; and/or copies of any of the foregoing documents.
National Defense Authorization Act Section 636; Public Law 107-314, Bob Stump National Defense Authorization Act for Fiscal Year 2003; 10 U.S.C. 1413a, as amended, Combat Related Special Compensation; 10 U.S.C. Chapter 61, Retirement or Separation for Physical Disability; AR 635-40, Physical Evaluation for Retention, Retirement, or Separation and E.O. 9397 (SSN).
To determine whether Army Retirees are entitled to combat-related special compensation; as a management tool to effectuate payment of combat-related special compensation; and to respond to official inquiries concerning the applications of particular applicants. The file may also be referred to by the Board for Correction of Army Records in conjunction with their subsequent review of applications from applicants.
In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act, these records or information contained therein may specifically be disclosed outside the DoD as a routine use pursuant to 5 U.S.C. 552(b)(3) as follows:
To officials and employees of the Department of Veterans Affairs to request and verify information of service-connected disabilities in order to evaluate applications for combat-related special compensation and effectuate pay.
This system of records contains individually identifiable health information. The DoD Health Information Privacy Regulation (DoD 6025.18-R) issued pursuant to the Health Insurance Portability and Accountability Act of 1996, applies to most such health information. DoD 6025.18-R may place additional procedural requirements on the uses and disclosures of such information beyond those found in the Privacy Act of 1974 or mentioned in this system of records notice.
Paper records in file folders and electronic storage media.
Individual's name, Social Security Number (SSN) and/or claim number.
Paper files are maintained in a secure room and are signed out as needed to appropriate representatives and are under the control of authorized personnel during working hours. Individual computerized system is password protected and access to the data base requires being afforded rights and being able to access AKO and authenticate using either a common access card (CAC) or AKO user name and password. System Administrators assign local access to database. The office is located in a secured building leased by the Army that has a 24-hour security force. All personnel are required to wear a badge to gain entrance. All staff are required to have annual HIPAA certification.
Paper copies are kept secured until digitization occurs. Once digitized and transferred to the Interactive Personnel Electronic Record Management System (iPERMS) the paper copy records are placed in burn bags and destroyed. iPERMS will destroy the electronic record 10 years after transfer.
Commander, Army Human Resources Command (AHRC), 200 Stovall Street, Alexandria, VA 22332.
Individuals seeking to determine whether information about themselves is contained in this system should address written inquiries to Army Human Resources Command (AHRC), Combat-Related Special Compensation (CRSC) Branch, 200 Stovall Street, Alexandria, VA 22332.
The request should contain the full name of the individual, military grade or rate, claim number, Social Security Number (SSN) and signed.
Individuals seeking access to information about themselves contained in the system should address written inquiries to the Army Human Resources Command (AHRC), Combat-Related Special Compensation (CRSC) Branch, 200 Stovall Street, Alexandria, VA 22332.
The request should contain the full name of the individual, military grade or rate, claim number, Social Security Number (SSN) and signed.
The Army's rules for accessing records, and for contesting contents and appealing initial agency determinations are contained in AR 340-21; 32 CFR part 505; or may be obtained from the system manager.
Army retirees who apply for combat-related special compensation; military medical boards and medical facilities; Department of Veterans Affairs and civilian medical providers and facilities; physical evaluation boards and other activities of the disability evaluation system; the Judge Advocate General; Army local command activities; the Defense Finance and Accounting Service; of the Department of Defense activities; and correspondence from members of Congress, attorneys, representatives, and other cognizant persons or parties.
None.
Department of Education.
The IC Clearance Official, Regulatory Information Management Services, Office of Management 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 July 7, 2008.
Written comments should be addressed to U.S. Department of Education, 400 Maryland Avenue, SW., LBJ, Washington, DC 20202-4537. Comments may also be electronically mailed to
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 IC Clearance Official, Regulatory Information Management Services, Office of Management, publishes that notice containing proposed information collection requests prior to submission of these requests to OMB. Each proposed information collection, grouped by office, contains the following: (1) Type of review requested, e.g. new, revision, extension, existing or reinstatement; (2) Title; (3) Summary of the collection; (4) Description of the need for, and proposed use of, the information; (5) Respondents and frequency of collection; and (6) Reporting and/or recordkeeping burden. OMB invites public comment.
Requests for copies of the information collection submission for OMB review may be accessed from
Comments regarding burden and/or the collection activity requirements should be electronically mailed to
Department of Education, Office of Elementary and Secondary Education.
Notice of Open Meeting.
This notice describes an open meeting of the Reading First Advisory Committee. Notice of the meeting is required by Section 10(a)(2) of the Federal Advisory Committee Act and is intended to notify the public of their opportunity to attend.
Monday, June 23, 2008 from 1 p.m. to 5 p.m. Eastern Daylight Time.
Westin Washington DC City Center at 1400 M Street, NW., Washington, DC 20005.
Deborah Spitz, Reading First Team Leader, Reading First Advisory Committee; 400 Maryland Avenue, SW., Washington, DC 20202; telephone: (202) 260-3793; fax: (202) 260-8969; e-mail:
The Reading First Advisory Committee is authorized by Sections 1203(c)(2)(a) and 1202(e)(2) of the Elementary and Secondary Education Act (ESEA) of 1965, as amended. The Committee is established within the Department of Education to evaluate Reading First applications submitted by States, to review the progress reports that States submit after the third year of the grant period, to advise on the awarding of Targeted Assistance Grants, and to advise the Secretary on other issues that the Secretary deems appropriate.
On May 1, 2008, the U.S. Department of Education's Institute of Education Sciences (IES) released the
The Final Report of the Impact Study, which will provide impact data from three years of program implementation and information on relationships between changes in instructional practice and student reading comprehension, is expected to be released in late 2008.
Individuals who will need accommodations for a disability in order to attend the meeting (e.g., interpreting services, assistance listening devices, or materials in alternative format) should notify Deborah Spitz at (202) 260-3793, no later than ten (10) days before the scheduled date of the meeting. We will attempt to meet requests for accommodations after this date but cannot guarantee their availability. The meeting site is accessible to individuals with disabilities.
Records are kept of all Committee proceedings and are available for public inspection at 400 Maryland Avenue, SW., Washington, DC 20202, from the hours of 9 a.m. to 5 p.m., Eastern Standard Time Monday through Friday.
To use PDF you must have Adobe Acrobat Reader, which is available free at this site. If you have questions about using PDF, call the U.S. Government Printing Office (GPO), toll free at 1-888-293-6498; or in the Washington, DC, area at (202) 512-1530.
The official version of this document is the document published in the
Department of Education.
List of Correspondence from January 2, 2008 through March 31, 2008.
The Secretary is publishing the following list pursuant to section 607(f) of the Individuals with Disabilities Education Act (IDEA). Under section 607(f) of IDEA, the Secretary is required, on a quarterly basis, to publish in the
Melisande Lee or JoLeta Reynolds. Telephone: (202) 245-7468.
If you use a telecommunications device for the deaf (TDD), you may call the Federal Relay Service (FRS) at 1-800-877-8339.
Individuals with disabilities may obtain a copy of this notice in an alternative format (
The following list identifies correspondence from the Department issued from January 2, 2008 through March 31, 2008. Included on the list are those letters that contain interpretations of the requirements of IDEA and its implementing regulations, as well as letters and other documents that the Department believes will assist the public in understanding the requirements of the law and its regulations. The date of and topic addressed by each letter are identified, and summary information is also provided, as appropriate. To protect the privacy interests of the individual or individuals involved, personally identifiable information has been redacted, as appropriate.
○ Letter dated January 15, 2008 to Coalition of Learning Disabled Chief Executive Officer Allen Brumbaugh, regarding criteria used under Part B of IDEA for determining whether a child is a “child with a disability” and requirements for individualized education programs (IEPs).
○ Letter dated March 11, 2007 to Mountain Plains Regional Resource Center Director John Copenhaver, clarifying that the policy regarding making a free appropriate public education (FAPE) available to children with disabilities, contained in the Office of Special Education Programs' letter dated April 10, 1995 to Ms. Kathy Balkman, remains consistent with the requirements of the reauthorized IDEA.
○ Letter dated March 17, 2008 to individual (personally identifiable information redacted), regarding the policy on the use of mechanical restraints or other aversive behavioral techniques for children with disabilities.
○ Letter dated February 1, 2008 to New Jersey Office of Special Education Programs Director Roberta Wohle, clarifying reporting on indicators in the State Performance Plan and Annual Performance Reports relating to the least restrictive environment provisions in Part B of IDEA.
○ Letter dated March 7, 2008 to Texas Education Agency General Counsel David Anderson, regarding complaints that allege violations of the confidentiality of information provisions in Part B of IDEA and the Family Educational Rights and Privacy Act.
○ Letter dated March 17, 2008 to individual (personally identifiable information redacted), regarding the interpretation of the requirements of Part B of IDEA that are applicable when a public agency places a preschool-age child with a disability in a private preschool that is not a school that is exclusively for children with disabilities as a means of providing FAPE to that child.
○ Letter dated January 25, 2008 to U.S. Senator Joseph I. Lieberman, regarding the obligations of States and local educational agencies (LEAs) to parentally-placed private school children with disabilities.
○ Letter dated February 4, 2008 to individual (personally identifiable information redacted), regarding a State complaint involving a public agency's obligation to provide private placements for children with disabilities at public expense.
○ Letter dated January 24, 2008 to Mountain Plains Regional Resource Center Director John Copenhaver, clarifying that Impact Aid funds and Medicaid funds are considered Federal funds, and may not be treated as State and local funds for maintenance of effort calculations.
○ Letter dated March 11, 2008 to Mountain Plains Regional Resource Center Director John Copenhaver, regarding requirements for membership on the State Advisory Panel.
○ Letter dated January 30, 2008 to New Mexico State Director of Special
○ Letter dated March 31, 2008 to individual (personally identifiable information redacted), clarifying that Part B of IDEA does not require that public agencies obtain parental consent within a specific time period when a child is referred for an evaluation.
○ Letter dated March 31, 2008 to individuals (personally identifiable information redacted), regarding how public agencies meet the requirements for notifying parents of the individuals who will be attending meetings of their child's IEP Team.
○ Letter dated March 17, 2008 to Howard County, Maryland Public School System Facilitator Ronald Caplan, regarding when it is appropriate to invite a representative of any participating agency likely to be responsible for providing or paying for transition services to an IEP Team meeting involving the consideration of the child's postsecondary goals and the transition services needed to assist the child in reaching those goals.
○ Letter dated March 17, 2008 to Utah At Risk and Special Education Services Director Nan Gray, regarding the requirement to obtain the consent of the parents or a child who has reached the age of majority prior to inviting a representative of any participating agency that is likely to be responsible for providing or paying for transition services to an IEP Team meeting involving the consideration of the child's postsecondary goals and the transition services needed to assist the child in reaching those goals.
○ Letter dated March 17, 2008 to Mountain Plains Regional Resource Center Director John Copenhaver, regarding electronic mail filings of State complaints and due process complaints.
○ Letter dated March 17, 2008 to New Jersey Office of the State Board of Appeals Acting Director John Worthington, clarifying when the due process hearing timeline would begin under specific circumstances after the 30-day resolution process has expired.
○ Letter dated February 1, 2008 to Nevada Office of Special Education and Diversity Programs Director Frankie McCabe, clarifying that OSEP continues to believe that the position set out in the April 24, 2007 memorandum, requiring States to reserve funds for comprehensive coordinated early intervening services when there is a finding of significant disproportionality based on race and ethnicity in disciplinary actions, is correct.
You may view this document, as well as all other Department of Education documents published in the
To use PDF you must have Adobe Acrobat Reader, which is available free at this site. If you have questions about using PDF, call the U.S. Government Printing Office (GPO), toll-free, at 1-888-293-6498; or in the Washington, DC, area at (202) 512-1530.
The official version of this document is the document published in the
The regulations in 34 CFR part 79 apply to all applicants except federally recognized Indian tribes.
The regulations in 34 CFR part 86 apply to institutions of higher education only.
The Assistant Secretary for Special Education and Rehabilitative Services may change the maximum amount through a notice published in the
The Department is not bound by any estimates in this notice.
1.
2.
Under 34 CFR 75.562(c), an indirect cost reimbursement on a training grant is limited to the recipient's actual indirect costs, as determined by its negotiated indirect cost rate agreement, or 8 percent of a modified total direct cost base, whichever amount is less. Indirect costs in excess of the 8 percent limit may not be charged directly, used to satisfy matching or cost-sharing requirements, or charged to another Federal award.
1.
You can contact ED Pubs at its Web site, also:
If you request an application package from ED Pubs, be sure to identify this program or competition as follows: CFDA number 84.264A.
Individuals with disabilities can obtain a copy of the application package in an alternative format (
2.
• A page is 8.5” by 11”, on one side only, with 1” margins at the top, bottom, and both sides.
• Double space (no more than three lines per vertical inch) all text in the application narrative, including titles, headings, footnotes, quotations, references, and captions, as well as all text in charts, tables, figures, and graphs.
• Use a font that is either 12 point or larger or no smaller than 10 pitch (characters per inch).
• Use one of the following fonts: Times New Roman, Courier, Courier New, or Arial. An application submitted in any other font (including Times Roman or Arial Narrow) will not be accepted.
The page limit does not apply to Part I, the cover sheet; Part II, the budget section, including the narrative budget justification; Part IV, the assurances and certifications; or the one-page abstract, the resumes, the bibliography, or the letters of support. However, the page limit does apply to all of the application narrative [Part III].
We will reject your application if you exceed the page limit; or if you apply other standards and exceed the equivalent of the page limit.
3.
Applications for grants under this competition must be submitted electronically using the Grants.gov Apply site (Grants.gov). For information (including dates and times) about how to submit your application electronically, or in paper format by mail or hand delivery if you qualify for an exception to the electronic submission requirement, please refer to section IV. 6.
We do not consider an application that does not comply with the deadline requirements.
Individuals with disabilities who need an accommodation or auxiliary aid in connection with the application process should contact the person listed under
4.
5.
6.
a. Electronic Submission of Applications. Applications for grants under the Rehabilitation Continuing Education Program—Regional Technical Assistance and Continuing Education (TACE) Centers, CFDA Number 84.264A, must be submitted electronically using the Governmentwide Grants.gov Apply site at
We will reject your application if you submit it in paper format unless, as described elsewhere in this section, you qualify for one of the exceptions to the electronic submission requirement and submit, no later than two weeks before the application deadline date, a written statement to the Department that you qualify for one of these exceptions. Further information regarding calculation of the date that is two weeks before the application deadline date is provided later in this section under
You may access the electronic grant application for Rehabilitation Continuing Education Program—Regional Technical Assistance and Continuing Education (TACE) Centers at
Please note the following:
• When you enter the Grants.gov site, you will find information about submitting an application electronically through the site, as well as the hours of operation.
• Applications received by Grants.gov are date and time stamped. Your application must be fully uploaded and submitted and must be date and time stamped by the Grants.gov system no later than 4:30 p.m., Washington, DC time, on the application deadline date.
• The amount of time it can take to upload an application will vary depending on a variety of factors, including the size of the application and the speed of your Internet connection. Therefore, we strongly recommend that you do not wait until the application deadline date to begin the submission process through Grants.gov.
• You should review and follow the Education Submission Procedures for submitting an application through Grants.gov that are included in the application package for this competition to ensure that you submit your application in a timely manner to the Grants.gov system. You can also find the Education Submission Procedures pertaining to Grants.gov at
• To submit your application via Grants.gov, you must complete all steps in the Grants.gov registration process (see
• You will not receive additional point value because you submit your application in electronic format, nor will we penalize you if you qualify for an exception to the electronic submission requirement, as described elsewhere in this section, and submit your application in paper format.
• You must submit all documents electronically, including all information you typically provide on the following forms: Application for Federal Assistance (SF 424), the Department of Education Supplemental Information for SF 424, Budget Information—Non-Construction Programs (ED 524), and all necessary assurances and certifications. Please note that two of these forms—the SF 424 and the Department of Education Supplemental Information for SF 424—have replaced the ED 424 (Application for Federal Education Assistance).
• You must attach any narrative sections of your application as files in a .DOC (document), .RTF (rich text), or .PDF (Portable Document) format. If you upload a file type other than the three file types specified in this paragraph or submit a password-protected file, we will not review that material.
• Your electronic application must comply with any page-limit requirements described in this notice.
• After you electronically submit your application, you will receive from Grants.gov an automatic notification of receipt that contains a Grants.gov tracking number. (This notification indicates receipt by Grants.gov only, not receipt by the Department.) The Department then will retrieve your application from Grants.gov and send a second notification to you by e-mail. This second notification indicates that the Department has received your application and has assigned your application a PR/Award number (an ED-specified identifying number unique to your application).
• We may request that you provide us original signatures on forms at a later date.
If you are prevented from electronically submitting your application on the application deadline date because of technical problems with the Grants.gov system, we will grant you an extension until 4:30 p.m., Washington, DC time, the following business day to enable you to transmit your application electronically or by hand delivery. You also may mail your application by following the mailing instructions described elsewhere in this notice.
If you submit an application after 4:30 p.m., Washington, DC time, on the application deadline date, please contact the person listed under
The extensions to which we refer in this section apply only to the unavailability of, or technical problems with, the Grants.gov system. We will not grant you an extension if you failed to register fully to submit your application to Grants.gov before the application deadline date and time or if the technical problem you experienced is unrelated to the Grants.gov system.
• You do not have access to the Internet; or
• You do not have the capacity to upload large documents to the Grants.gov system; and
• No later than two weeks before the application deadline date (14 calendar days or, if the fourteenth calendar day before the application deadline date falls on a Federal holiday, the next business day following the Federal holiday), you mail or fax a written statement to the Department, explaining which of the two grounds for an exception prevent you from using the Internet to submit your application.
If you mail your written statement to the Department, it must be postmarked no later than two weeks before the application deadline date. If you fax your written statement to the Department, we must receive the faxed statement no later than two weeks before the application deadline date.
Address and mail or fax your statement to: Christine Marschall, U.S. Department of Education, 400 Maryland Avenue, SW., room 5053, PCP, Washington, DC 20202-2800. FAX: (202) 245-6824.
Your paper application must be submitted in accordance with the mail or hand delivery instructions described in this notice.
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If you qualify for an exception to the electronic submission requirement, you may mail (through the U.S. Postal Service or a commercial carrier) your application to the Department. You must mail the original and two copies of your application on or before the application deadline date, to the Department at the applicable following address:
or
Regardless of which address you use, you must show proof of mailing consisting of one of the following:
(1) A legibly dated U.S. Postal Service postmark.
(2) A legible mail receipt with the date of mailing stamped by the U.S. Postal Service.
(3) A dated shipping label, invoice, or receipt from a commercial carrier.
(4) Any other proof of mailing acceptable to the Secretary of the U.S. Department of Education.
If you mail your application through the U.S. Postal Service, we do not accept either of the following as proof of mailing:
(1) A private metered postmark.
(2) A mail receipt that is not dated by the U.S. Postal Service.
If your application is postmarked after the application deadline date, we will not consider your application.
The U.S. Postal Service does not uniformly provide a dated postmark. Before relying on this method, you should check with your local post office.
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If you qualify for an exception to the electronic submission requirement, you (or a courier service) may deliver your paper application to the Department by hand. You must deliver the original and two copies of your application by hand on or before the application deadline date, to the Department at the following address:
U.S. Department of Education, Application Control Center,
The Application Control Center accepts hand deliveries daily between 8 a.m. and 4:30 p.m., Washington, DC time, except Saturdays, Sundays, and Federal holidays.
(1) You must indicate on the envelope and—if not provided by the Department—in Item 11 of the SF 424 the CFDA number, including suffix letter, if any, of the competition under which you are submitting your application; and
(2) The Application Control Center will mail to you a notification of receipt of your grant application. If you do not receive this notification within 15 business days from the application deadline date, you should call the U.S. Department of Education Application Control Center at (202) 245-6288.
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If your application is not evaluated or not selected for funding, we notify you.
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We reference the regulations outlining the terms and conditions of an award in the
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Christine Marschall, U.S. Department of Education, 400 Maryland Avenue, SW., room 5053, PCP, Washington, DC 20202-2800. Telephone: (202) 245-7429 or by e-mail:
If you use a TDD, call the FRS, toll free, at 1-800-877-8339.
To use PDF you must have Adobe Acrobat Reader, which is available free at this site. If you have questions about using PDF, call the U.S. Government Printing Office (GPO), toll free, at 1-888-293-6498; or in the Washington, DC, area at (202) 512-1530.
The official version of this document is the document published in the
Office of Special Education and Rehabilitative Services, Department of Education.
Notice of final priority.
The Assistant Secretary for Special Education and Rehabilitative Services announces a priority under the Rehabilitation Continuing Education Program (RCEP) to fund regional Technical Assistance and Continuing Education (TACE) centers. The Assistant Secretary may use this priority for competitions in fiscal year (FY) 2008 and later years. We take this action to improve the quantity and quality of employment outcomes for individuals with disabilities through enhanced technical assistance (TA) and continuing education (CE) for State vocational rehabilitation (VR) agencies and agency partners that cooperate with State VR agencies in providing VR and other rehabilitation services (
Christine Marschall, U.S. Department of Education, 400 Maryland Ave., SW., Room 5053, Potomac Center Plaza, Washington, DC 20202-2800. Telephone: (202) 245-7429 or via Internet:
If you use a telecommunications device for the deaf (TDD), call the Federal Relay Service (FRS) at 1-800-877-8339.
Individuals with disabilities can obtain this document in an alternative format (
Through this priority, the Department revises the current structure of the RCEP, which includes 21 regional RCEP centers—11 centers that serve primarily State VR agencies and 10 centers that serve primarily CRPs. Instead of funding these two separate sets of centers, this priority supports 10 regional Technical Assistance and Continuing Education (TACE) centers to serve State VR agencies and agency partners that cooperate with State VR agencies in providing VR and other rehabilitation services. CRPs are among the agency partners that the TACE centers are expected to serve. While the current RCEP centers provide CE and limited TA to entities, TACE centers will provide both TA and CE as necessary to respond to the needs of the State VR agencies and agency partners served by the TACE centers.
We published a notice of proposed priority (NPP) for this program in the
In response to our invitation in the NPP, 79 parties submitted comments on the proposed priority. An analysis of the comments and of any changes in the priority since publication of the NPP follows.
Multiple commenters raised a number of similar issues; therefore, we group major issues by subject area. Generally, we do not address technical and other minor changes and suggested changes the law does not authorize us to make under the applicable statutory authority.
Members of the advisory committee include, at a minimum, the entities listed in 34 CFR 385.40 as well as those additional entities listed in paragraph (3) of the priority. We believe that adding a representative from each State VR agency in a TACE center's region will increase opportunities for State VR agencies to inform the TACE center about their needs and to provide input into a TACE center's annual work plan. For this reason, we are modifying the priority to require each TACE center to invite a representative from the State VR agencies in the TACE center's region to participate on its advisory committee.
It was not the intent of the priority that the needs assessment be based solely on VR State plans. These plans are listed as one of the data sources to be reviewed when conducting the needs assessment. Paragraph (2) of the priority lists several other sources of data that must be considered in the annual needs assessment, including on-site monitoring reports and annual review reports issued by RSA, other performance and compliance information from RSA and State VR agencies, and other data, as appropriate.
We also do not intend for the needs assessment in this priority to be a deficiency-based model. Instead, we expect that the needs assessment process will be guided by each TACE center's advisory committee to ensure
We recognize that other areas of need may arise through the needs assessment and do not wish to limit the areas of expertise to those identified in the priority. Therefore, we have changed the priority to clarify that each TACE center must have expertise or access to subject matter experts in, at a minimum, the 12 areas of expertise identified in the third paragraph of the priority.
Finally, nothing in the priority prevents a TACE center from consulting with the State VR agency to select its experts.
This notice does not solicit applications. In any year in which we choose to use this priority, we invite applications through a notice in the
The Assistant Secretary for Special Education and Rehabilitative Services establishes a priority to create 10 regional Technical Assistance and Continuing Education (TACE) centers to provide (1) technical assistance (TA) to State vocational rehabilitation (VR) agencies and agencies with which State VR agencies cooperate in providing VR and other rehabilitation services (agency partners) to improve services required under the Rehabilitation Act of 1973, as amended, and (2) continuing education (CE) to employees of State VR agencies and agency partners. For purposes of this priority, the term “agency partners” refers to all agencies with which the State VR agencies served by the TACE center cooperate in providing VR and other rehabilitation services.
Under this priority, the TACE centers must contribute to the following outcomes: improved quality of VR services, increased effectiveness and efficiency of State VR agencies in delivering VR services, and improved quantity and quality of VR employment outcomes for individuals with disabilities. The TACE centers must contribute to these outcomes by providing TA and CE, either directly or through contract, to employees of State VR agencies and agency partners on topics that are identified jointly by the Rehabilitation Services Administration (RSA) and each TACE center's advisory committee and included in the TACE center's annual work plan.
Under this priority, applicants must demonstrate their ability to respond rapidly to a broad range of TA and CE needs. Applicants must provide evidence in their applications that they have expertise, or access to subject-matter experts with experience, in conducting TA and CE in at least the following areas: Improvement of State VR agencies' service delivery; practices and interventions related to specific VR populations; quality assurance; case management at the administrative and counselor level; the use of assistive technology to achieve employment goals; personnel management (
1. Establish an annual work plan, in coordination with and subject to the approval of RSA, describing activities that it will conduct to assist State VR agencies to accomplish the goals identified in their VR State plans and to achieve other performance and compliance goals identified by RSA's monitoring reports. The annual work plan must identify the nature and scope, including delivery means and methods, of the TA and CE to be provided by the TACE center and consider, but not necessarily address, the TA and CE needs of State VR agencies and agency partners identified in the TACE center's annual needs assessment;
2. Conduct an annual needs assessment to identify the TA and CE needs of State VR agencies and agency partners in its region. Each TACE center must base its annual needs assessment on a thorough review of VR State plans, on-site monitoring reports and annual review reports issued by RSA, other performance and compliance information available from RSA and State VR agencies, and other data, as appropriate;
3. Establish a center advisory committee to provide input on the annual needs assessments conducted by the TACE center in accordance with paragraph (2) of this priority. In addition to the requirements in 34 CFR 385.40 for mandatory members of the center advisory committee, the committee must invite representatives from each of the State VR agencies in the region served by the TACE center and from RSA's Independent Living Training and Technical Assistance
Members of minority groups are listed in 34 CFR 385.40 as one of the categories of mandatory participants on rehabilitation training advisory committees. However, the Department intends to publish a notice of proposed rulemaking (NPRM) to amend 34 CFR 385.40, which would remove the requirement that an applicant include members of minority groups on all project advisory committees. The NPRM would add a requirement that an applicant include individuals who are knowledgeable about the special needs of individuals with disabilities from diverse groups, including minority groups. The purpose of this change would be to more clearly reflect the Department's intent that project advisory committees include individuals who are familiar with the needs of individuals with disabilities from diverse groups, rather than individuals who are just members of such groups;
4. Serve as an observer in RSA's monitoring of State VR agencies in its region by participating, at a minimum, in each State VR agency's monitoring exit conference in order to gain a thorough understanding of each State VR agency's TA and CE needs;
5. Collaborate and coordinate with other TACE centers to provide TA and CE as efficiently as possible to employees of State VR agencies and agency partners that have similar needs. TA should be evidence-based, to the extent possible, and include information on best practices to the extent evidence or research is available.
6. Coordinate services with other entities that provide TA and CE to State VR agencies and agency partners, including, but not limited to, Independent Living Training and Technical Assistance grantees and Assistive Technology projects funded by RSA; and
7. Evaluate how well each TA and CE activity provided by the TACE center meets a targeted area of need (
This notice of final priority (NFP) has been reviewed in accordance with Executive Order 12866. Under the terms of the order, we have assessed the potential costs and benefits of this regulatory action.
The potential costs associated with the NFP are those resulting from statutory requirements and those we have determined as necessary for administering this program effectively and efficiently.
In assessing the potential costs and benefits—both quantitative and qualitative—of this NFP, we have determined that the benefits of the final priority justify the costs.
We have also determined that this regulatory action does not unduly interfere with State, local, and tribal governments in the exercise of their governmental functions.
We summarized the costs and benefits in the NPP.
This program is subject to Executive Order 12372 and the regulations in 34 CFR part 79. One of the objectives of the Executive order is to foster an intergovernmental partnership and a strengthened federalism. The Executive order relies on processes developed by State and local governments for coordination and review of proposed Federal financial assistance.
This document provides early notification of our specific plans and actions for this program.
You may view this document, as well as all other Department of Education documents published in the
To use PDF you must have Adobe Acrobat Reader, which is available free at this site. If you have questions about using PDF, call the U.S. Government Printing Office (GPO), toll free, at 1-888-293-6498; or in the Washington, DC, area at (202) 512-1530.
The official version of this document is the document published in the
29 U.S.C. 772.
This priority is:
Ongoing communication, collaboration, and coordination among the centers in the OSEP TA&D Network are essential to (a) increase the impact of the TA&D centers' efforts, (b) maximize efficiency, and (c) ensure that products and services are non-duplicative. Furthermore, communication, collaboration, and coordination between OSEP's TA&D Network and other relevant federally-funded TA&D centers are necessary to improve early intervention and education outcomes for children with disabilities. For example, the Department's Office of Elementary and Secondary Education (OESE) funds a Comprehensive Center on Assessments, which provides TA to States on assessment issues related to all children, including children with disabilities; and the U.S. Department of Health and Human Services supports the Center for Social and Emotional Foundations for Early Learning.
Communication, collaboration, and coordination, however, are difficult to initiate and sustain without logistical (e.g., arranging meetings, coordinating schedules) and structural supports (e.g., documenting decisions, developing agendas).
OSEP funded a Federal Resource Center for Special Education (FRC) in 2003 as a way to facilitate communication, collaboration, and coordination among OSEP-funded Regional Resource Centers (RRCs). The FRC worked closely with the six RRCs to help them coordinate their TA to States. In addition to the coordination among RRCs, the FRC coordinated, to a limited extent, the exchange of information between the RRCs and other OSEP and Department-funded TA&D centers. (For further information on the work of the FRC, go to
To be considered for funding under this absolute priority, applicants must meet the application requirements contained in this priority. A project funded under the absolute priority also must meet the programmatic and administrative requirements specified in the priority.
(a) A logic model that depicts, at a minimum, the goals, activities, outputs, and outcomes of the proposed project. A logic model communicates how a project will achieve its outcomes and provides a framework for both the formative and summative evaluations of the project;
The following Web site provides more information on logic models and lists multiple online resources:
(b) A plan to implement the activities described in the
(c) A plan, linked to the proposed project's logic model, for a formative evaluation of the proposed project's activities. The plan must describe how the formative evaluation will use clear performance objectives to ensure continuous improvement in the operation of the proposed project, including objective measures of progress in implementing the project and ensuring the quality of products and services;
(d) A budget for attendance at the following:
(1) A one and one half day kick-off meeting to be held in Washington, DC within four weeks after receipt of the award, and an annual planning meeting held in Washington, DC with the OSEP Project Officer during each subsequent year of the project period.
(2) A three-day Project Directors' Conference in Washington, DC during each year of the project period.
(3) Five two-day trips annually to attend Department briefings, Department-sponsored conferences, and other meetings requested by OSEP; and
(e) A line item in the proposed budget for an annual set-aside of five percent of the grant amount to support emerging needs that are consistent with the proposed project's activities, as those needs are identified in consultation with OSEP.
With approval from the OSEP Project Officer, the TACC must reallocate any remaining funds from this annual set-aside no later than the end of the third quarter of each budget period.
(a) Facilitate ongoing communication, collaboration, and coordination among the centers in the OSEP TA&D Network, and between those centers and other Department-funded TA&D centers, including the Comprehensive Centers, Equity Assistance Centers, and Regional Educational Laboratories; relevant TA centers funded by the U.S. Department of Health and Human Services; national professional organizations, and other stakeholders, as appropriate. The TACC, at a minimum, must—
(1) Provide logistical support to establish and maintain topical workgroups comprised of OSEP TA&D Network center staff, including information specialists and other TA&D staff, as appropriate, to share information and develop coordinated TA strategies and products on issues, priorities, and strategic initiatives identified by OSEP.
(2) Establish and maintain listservs and other electronic mechanisms for communication, collaboration, and coordination.
(3) Maintain OSEP's Proposed Product Advisory Board (PPAB), which reviews information on products proposed by the OSEP TA&D Network centers to ensure non-duplication of products across TA&D centers. Information about PPAB is available at:
(4) Maintain and expand, as appropriate, the communities of practice Web site (
(5) Develop, maintain, update, and integrate, when appropriate, searchable databases of OSEP's (i) discretionary grants, (ii) TA&D Network centers' proposed and current products and services, and (iii) events. This work must include, at a minimum, the following:
(i) Expanding, modifying, maintaining, and integrating, as appropriate, the existing databases of OSEP-funded discretionary grants and their products to assist in coordinating TA&D activities within and across all Part D programs. These databases include the OSEP Discretionary Projects Databases, which must be in compliance with the 2002 E-Government Act and the 2002 Federal Information Security Management Act requirements. Information about these databases is available at:
(ii) Expanding the TA&D Matrix, which is a searchable database that provides current information on Department-funded TA services to a range of stakeholders, to include current information on federally-funded early intervention and early childhood education TA services. This matrix must be integrated with the databases mentioned in paragraph (i). Information about the TA&D Matrix is available at:
(6) Maintain and update, at least twice annually, the TA&D Placemat, which is a tool that includes the contact information for all Department-funded TA&D centers. The current TA&D Placemat is available at:
(7) Maintain a Web portal that includes—(i) a work area for the OSEP TA&D Network centers to develop and share resources and products and that links to the Web sites operated by centers in the OSEP TA&D Network; and (ii) an events calendar that includes information on national and regional events hosted by the OSEP TA&D Network centers and OSEP.
(8) Provide an orientation for new OSEP TA&D Network centers and ongoing support for existing OSEP TA&D Network centers on topics such as: (i) PPAB product submission guidelines; (ii) TA&D Matrix data input and maintenance; (iii) Events calendar input and maintenance; (iv) Communities of practice participation; (v) Web site protocols; (vi) Annual performance report (APR) schedules and updates; and (vii) Government Performance and Results Act performance measures.
(b) Facilitate ongoing communication, collaboration, and coordination among the OSEP TA&D Network regional centers, such as the RRCs and the Postsecondary Education Programs Network Regional Centers. The TACC, at a minimum, must (i) develop and maintain an area of the Web portal for use by these regional TA&D centers, (ii) coordinate monthly phone calls among the regional TA&D centers, and (iii) establish and maintain topical workgroups comprised of staff across the regional TA&D centers to identify and develop TA tools and resources.
(c) Support OSEP in sharing information with the OSEP TA&D Network, States, national professional organizations, and other relevant stakeholders on national priorities, issues, and initiatives. The TACC, at a minimum, must—
(i) Provide logistical support for annual conferences hosted by OSEP (e.g., Leadership Conference, TA&D Conference, Joint Leveraging Resources Conference, and Summer Monitoring Institutes) as well as any national meetings, public meetings, and hearings associated with the reauthorization of IDEA.
(ii) Maintain and update, as appropriate, OSEP's existing IDEA Web site (located at
(iii) Maintain and update, as appropriate, the State Performance Plans (SPPs) and APRs Planning Calendar, which contains information to assist States with the preparation and timely completion of their SPPs and APRs. The Web portal referenced in paragraph (a)(7) of the
(iv) Develop a summary report for all SPP and APR performance and compliance indicators using data compiled by centers within the OSEP TA&D Network that includes information about States' progress in meeting targets for IDEA Part B and Part C indicators, as well as any revisions made to States' monitoring and data systems, measurement systems, or improvement strategies. OSEP staff and the OSEP TA&D Network centers will use this information to plan and coordinate their TA efforts. The TACC must participate in OSEP-requested teleconferences to discuss the findings of the summary report.
(d) Prepare and disseminate reports, documents, and other materials on OSEP-sponsored conference proceedings, Federal initiatives and policies, evidence-based TA practices, and related topics, as requested by OSEP, for specific audiences, including the OSEP TA&D Network centers, other federally-funded TA&D centers, SEAs, LEAs, and Part C lead agencies. In consultation with the OSEP Project Officer, make selected reports, documents, and other materials available in both English and Spanish, when appropriate.
(e) Ensure that any Web site established or maintained by the TACC under this priority meets a government or an industry-recognized standard for accessibility.
(a) Establish and maintain an advisory committee to review the activities and outcomes of the TACC and provide programmatic support and advice throughout the project period. At a minimum, the advisory committee must
(b) Communicate and collaborate, on an ongoing basis, with OSEP-funded projects outside of the TA&D Network, including Parent Training and Information Centers, personnel preparation projects, State Personnel Development Grant projects, and State TA Deaf-Blind projects to support the ongoing exchange of information and resources.
(c) Prior to developing any new product, whether paper or electronic, submit to the OSEP Project Officer, for approval, a proposal describing the content and purpose of the product.
(d) Collaborate with the National Dissemination Center for Individuals with Disabilities, which OSEP intends to fund in FY 2008, to develop an efficient and high-quality dissemination strategy that reaches the broad audiences to be targeted by the project. The TACC must report to the OSEP Project Officer the outcomes of these coordination efforts.
(e) Conduct a summative evaluation of the TACC in collaboration with the OSEP-funded Center to Improve Project Performance (CIPP) as described in the following paragraphs. This summative evaluation must examine the outcomes or impact of the TACC's activities in order to assess the effectiveness of those activities.
The major tasks of CIPP would be to guide, coordinate, and oversee the summative evaluations conducted by selected Technical Assistance, Personnel Development, Parent Training and Information Center, and Technology projects that individually receive $500,000 or more funding from OSEP annually. The efforts of CIPP are expected to enhance individual project evaluations by providing expert and unbiased assistance in designing evaluations, conducting analyses, and interpreting data.
To fulfill the requirements of the summative evaluation to be conducted under the guidance of CIPP and with the approval of the OSEP Project Officer, the TACC must—
(1) Hire or designate, with the approval of the OSEP Project Officer, a project liaison staff person with sufficient dedicated time, experience in evaluation, and knowledge of the TACC to work with CIPP on the following tasks: (i) Planning for the TACC's summative evaluation (e.g., selecting evaluation questions, developing a timeline for the evaluation, locating sources of relevant data, and refining the logic model used for the evaluation), (ii) developing the summative evaluation design and instrumentation (e.g., determining quantitative or qualitative data collection strategies, selecting respondent samples, and pilot testing instruments), (iii) coordinating the evaluation timeline with the implementation of TACC activities, (iv) collecting summative data, and (v) writing reports of summative evaluation findings;
(2) Cooperate with CIPP staff in order to accomplish the tasks described in paragraph (1) of this section; and
(3) Dedicate $60,000 of the annual budget request for this project to cover the costs of carrying out the tasks described in paragraphs (1) and (2) of this section, implementing the TACC's formative evaluation, and traveling to Washington, DC in the second year of the project period for the TACC's review for continued funding.
(f) Maintain ongoing communication with the OSEP Project Officer through monthly phone conversations and e-mail communication.
(a) The recommendation of a review team consisting of experts selected by the Secretary. This review will be conducted during a one-day intensive meeting in Washington, DC that will be held during the last half of the second year of the project period;
(b) The timeliness and effectiveness with which all requirements of the negotiated cooperative agreement have been or are being met by the TACC; and
(c) The quality, relevance, and usefulness of the TACC's activities and products and the degree to which the TACC's activities and products have contributed to changed practice and improved communication, collaboration, and coordination among OSEP TA&D Network centers.
The regulations in 34 CFR part 79 apply to all applicants except federally recognized Indian tribes.
The regulations in 34 CFR part 86 apply to institutions of higher education (IHEs) only.
The Department is not bound by any estimates in this notice.
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(b) Applicants and grant recipients funded under this competition must involve individuals with disabilities or parents of individuals with disabilities ages birth through 26 in planning, implementing, and evaluating the projects (see section 682(a)(1)(A) of IDEA).
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You can contact ED Pubs at its Web site, also,
If you request an application package from ED Pubs, be sure to identify this program or competition as follows: CFDA Number 84.326Z.
Individuals with disabilities can obtain a copy of the application package in an alternative format (e.g., Braille, large print, audiotape, or computer diskette) by contacting the person or team listed under
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Page Limit: The application narrative (Part III of the application) is where you, the applicant, address the selection criteria that reviewers use to evaluate your application. You must limit the application narrative to the equivalent of no more than 70 pages, using the following standards:
• A “page” is 8.5″ x 11″, on one side only, with 1″ margins at the top, bottom, and both sides.
• Double space (no more than three lines per vertical inch) all text in the application narrative, including titles, headings, footnotes, quotations, references, and captions, as well as all text in charts, tables, figures, and graphs.
• Use a font that is either 12 point or larger, or no smaller than 10 pitch (characters per inch).
The page limit does not apply to Part I, the cover sheet; Part II, the budget section, including the narrative budget justification; Part IV, the assurances and certifications; or the one-page abstract, the resumes, the bibliography, the references, or the letters of support. The page limit, however, does apply to the application narrative in Part III.
We will reject your application if you exceed the page limit or if you use other standards and exceed the equivalent of the page limit.
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Applications for grants under this competition may be submitted electronically using the Grants.gov Apply site (Grants.gov), or in paper format by mail or hand delivery. For information (including dates and times) about how to submit your application electronically, or in paper format by mail or hand delivery, please refer to section IV.6.
We do not consider an application that does not comply with the deadline requirements.
Individuals with disabilities who need an accommodation or auxiliary aid in connection with the application process should contact the person listed under
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If you choose to submit your application electronically, you must use the Governmentwide Grants.gov Apply site at
You may access the electronic grant application for the Technical Assistance Coordination Center competition at
Please note the following:
• Your participation in Grants.gov is voluntary.
• When you enter the Grants.gov site, you will find information about submitting an application electronically through the site, as well as the hours of operation.
• Applications received by Grants.gov are date and time stamped. Your application must be fully uploaded and submitted and must be date and time stamped by the Grants.gov system no later than 4:30 p.m., Washington, DC time, on the application deadline date. Except as otherwise noted in this section, we will not consider your application if it is date and time stamped by the Grants.gov system later than 4:30 p.m., Washington, DC time, on the application deadline date. When we retrieve your application from Grants.gov, we will notify you if we are rejecting your application because it was date and time stamped by the Grants.gov system after 4:30 p.m., Washington, DC time, on the application deadline date.
• The amount of time it can take to upload an application will vary depending on a variety of factors, including the size of the application and the speed of your Internet connection. Therefore, we strongly recommend that you do not wait until the application deadline date to begin the submission process through Grants.gov.
• You should review and follow the Education Submission Procedures for submitting an application through Grants.gov that are included in the application package for this competition to ensure that you submit your application in a timely manner to the Grants.gov system. You can also find the Education Submission Procedures pertaining to Grants.gov at
• To submit your application via Grants.gov, you must complete all steps in the Grants.gov registration process (see
• You will not receive additional point value because you submit your application in electronic format, nor will we penalize you if you submit your application in paper format.
• If you submit your application electronically, you must submit all documents electronically, including all information you typically provide on the following forms: Application for Federal Assistance (SF 424), the Department of Education Supplemental Information for SF 424, Budget Information—Non-Construction Programs (ED 524), and all necessary assurances and certifications. Please note that two of these forms—the SF 424 and the Department of Education Supplemental Information for SF 424—have replaced the ED 424 (Application for Federal Education Assistance).
• If you submit your application electronically, you must attach any narrative sections of your application as files in a .DOC (document), .RTF (rich text), or .PDF (Portable Document) format. If you upload a file type other than the three file types specified in this paragraph or submit a password-protected file, we will not review that material.
• Your electronic application must comply with any page-limit requirements described in this notice.
• After you electronically submit your application, you will receive from Grants.gov an automatic notification of receipt that contains a Grants.gov tracking number. (This notification indicates receipt by Grants.gov only, not receipt by the Department.) The Department then will retrieve your application from Grants.gov and send a second notification to you by e-mail. This second notification indicates that the Department has received your application and has assigned your application a PR/Award number (an ED-specified identifying number unique to your application).
• We may request that you provide us original signatures on forms at a later date.
If you are prevented from electronically submitting your application on the application deadline date because of technical problems with the Grants.gov system, we will grant you an extension until 4:30 p.m., Washington, DC time, the following business day to enable you to transmit your application electronically or by hand delivery. You also may mail your application by following the mailing instructions described elsewhere in this notice.
If you submit an application after 4:30 p.m., Washington, DC time, on the application deadline date, please contact the person listed under
The extensions to which we refer in this section apply only to the unavailability of, or technical problems with, the Grants.gov system. We will not grant you an extension if you failed to fully register to submit your application to Grants.gov before the application deadline date and time or if the technical problem you experienced is unrelated to the Grants.gov system.
b.
If you submit your application in paper format by mail (through the U.S. Postal Service or a commercial carrier), you must mail the original and two copies of your application, on or before the application deadline date, to the Department at the applicable following address:
Regardless of which address you use, you must show proof of mailing consisting of one of the following:
(1) A legibly dated U.S. Postal Service postmark.
(2) A legible mail receipt with the date of mailing stamped by the U.S. Postal Service.
(3) A dated shipping label, invoice, or receipt from a commercial carrier.
(4) Any other proof of mailing acceptable to the Secretary of the U.S. Department of Education.
If you mail your application through the U.S. Postal Service, we do not accept either of the following as proof of mailing:
(1) A private metered postmark.
(2) A mail receipt that is not dated by the U.S. Postal Service.
If your application is postmarked after the application deadline date, we will not consider your application.
The U.S. Postal Service does not uniformly provide a dated postmark. Before relying on this method, you should check with your local post office.
c.
If you submit your application in paper format by hand delivery, you (or a courier service) must deliver the original and two copies of your application by hand, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Application Control Center, Attention: (CFDA Number 84.326Z), 550 12th Street, SW., Room 7041, Potomac Center Plaza, Washington, DC 20202-4260.
The Application Control Center accepts hand deliveries daily between 8 a.m. and 4:30 p.m., Washington, DC time, except Saturdays, Sundays, and Federal holidays.
If you mail or hand deliver your application to the Department—
(1) You must indicate on the envelope and—if not provided by the Department—in Item 11 of the SF 424 the CFDA number, including suffix letter, if any, of the competition under which you are submitting your application; and
(2) The Application Control Center will mail to you a notification of receipt of your grant application. If you do not receive this notification within 15 business days from the application deadline date, you should call the U.S. Department of Education Application Control Center at (202) 245-6288.
1.
2.
1.
If your application is not evaluated or not selected for funding, we notify you.
2.
We reference the regulations outlining the terms and conditions of an award in the
3.
4.
Grantees will be required to provide information related to these measures in annual reports to the Department.
Grantees also will be required to report information on their project's performance in annual reports to the Department (34 CFR 75.590).
If you use a TDD, call the Federal Relay Service (FRS), toll-free, at 1-800-877-8339.
To use PDF you must have Adobe Acrobat Reader, which is available free at this site. If you have questions about using PDF, call the U.S. Government Printing Office (GPO), toll free, at 1-888-293-6498; or in the Washington, DC, area at (202) 512-1530.
The official version of this document is the document published in the
United States Election Assistance Commission.
Notice of public meeting.
Thursday, June 19, 2008, 10 a.m.-3 p.m.
U.S. Election Assistance Commission, 1225 New York Ave, NW., Suite 150, Washington, DC 20005 (Metro Stop: Metro Center).
The Commissioners will consider the following items:
Commissioners will consider and vote on whether to modify Advisory Opinion 07-003-A regarding Maintenance of Effort (MOE) funding, pursuant to HAVA Section 254 (a)(7). Commissioners will consider and vote on a Proposed Replacement Advisory Opinion 07-003-B Regarding Maintenance of Effort. Commissioners will consider the Adoption of EAC Draft Chapters of the Election Management Guidelines Project; Commissioners will consider the Adoption of EAC Laboratory Accreditation Program Manual; Commissioners will consider a Draft Policy for Joint Partnership Task Force of EAC and State Election Officials Regarding Spending of HAVA Funds; Commissioners will consider a Draft Policy for Notice and Public Comment; Commissioners will consider a Draft Policy regarding Allocable Cost Principles for HAVA Funding. Commissioners will consider whether to update the Maryland state instructions, the Michigan state instructions and the Louisiana state instructions on the national voter registration form. Commissioners will consider Administrative Regulations. Commissioners will receive a briefing regarding a HAVA State Spending Report to Congress; Commissioners will receive a Presentation on a Draft of EAC Guidance to States Regarding Updates to the State Plans; Commissioners will receive a Presentation on EAC Draft
This meeting will be open to the public.
Bryan Whitener, Telephone: (202) 566-3100.
Environmental Protection Agency (EPA).
Notice.
In compliance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Additional comments may be submitted on or before July 7, 2008.
Submit your comments, referencing Docket ID No. EPA-HQ-OW-2004-0013 to (1) EPA online using
Jill Dean, Drinking Water Protection Division—Prevention Branch, Office of Ground Water and Drinking Water (MC 4606M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 202-564-8241; fax number: 202-564-3756; e-mail address:
EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On February 29, 2008 (73 FR 11108), EPA sought comments on this ICR pursuant to 5 CFR 1320.8(d). EPA received no comments. Any additional comments on this ICR should be submitted to EPA and OMB within 30 days of this notice.
EPA has established a public docket for this ICR under Docket ID No. EPA-HQ-OW-2004-0013, which is available for online viewing at
Use EPA's electronic docket and comment system at
The 2006-2011 EPA Strategic Plan incorporates a source water contamination prevention measure to describe the voluntary source water protection (SWP) actions taken at the local or regional level based on the results of completed source water assessments. EPA's strategic target for SWP sets a goal of minimized risk to public health in 50 percent of community water systems (CWSs) and the 62 percent of the U.S. population served by those CWSs by 2011. Achieving minimized risk to public health focuses on developing and substantially implementing SWP strategies to address potential contamination risks within each CWS source water area.
EPA is collecting, on a voluntary basis, data from the States on their progress toward substantial implementation of prevention strategies for all CWS SWAs. While Section 1453(a)(3) of the SDWA does not authorize source water protection, States are encouraged to use the data collected in the source water assessments to develop protection plans for source water areas. Drinking Water State Revolving Fund monies authorized in Section 1452(g)(2)(B) may be used for activities to support efforts in source water protection. The
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, 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 Paperwork Reduction Act (PRA) comments should be submitted on or before July 7, 2008. 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 contacts listed below as soon as possible.
Direct all PRA comments to Nicholas A. Fraser, Office of Management and Budget, via Internet at
To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the Web page
For additional information or copies of the information collection(s), contact Cathy Williams at (202) 418-2918.
47 CFR Section 76.94(b) requires broadcasters entering into contracts providing for network non-duplication protection to notify cable systems within 60 days of the signing of such a contract. If they are unable to provide notices as provided for in Section
47 CFR Section 76.94(d) requires broadcasters to provide the following information to cable television systems under the following circumstances: (1) In the event the protection specified in the notices described in 47 CFR Section 76.94(a) or (b) has been limited or ended prior to the time specified in the notice, or in the event a time period, as identified to the cable system in a notice pursuant to Section 76.94(b) for which a broadcaster has obtained protection is shifted to another time of day or another day (but not expanded), the broadcaster shall, as soon as possible, inform each cable television system operator that has previously received the notice of all changes from the original notice. Notice to be furnished “as soon as possible” under this subsection shall be furnished by telephone, telegraph, facsimile, overnight mail or other similar expedient means. (2) In the event the protection specified in the modified notices described in Section 76.94(b) has been expanded, the broadcaster shall, at least 60 calendar days prior to broadcast of a protected program entitled to such expanded protection, notify each cable system operator that has previously received notice of all changes from the original notice.
47 CFR Sections 76.94(e)(2) and 76.105(c)(2) state that if a cable television system asks a television station for information about its program schedule, the television station shall answer the request.
47 CFR Sections 76.94(f) and 76.107 require a distributor or broadcaster exercising exclusivity to provide to the cable system, upon request, an exact copy of those portions of the contracts, such portions to be signed by both the network and the broadcaster, setting forth in full the provisions pertinent to the duration, nature, and extent of the non-duplication terms concerning broadcast signal exhibition to which the parties have agreed. Providing copies of relevant portions of the contracts is assumed to be accomplished in the notification process set forth in Sections 76.94 and 76.105.
47 CFR Section 76.95 states that the provisions of Sections 76.92 through 76.94 (including the notification provisions of Section 76.94) shall not apply to a cable system serving fewer than 1,000 subscribers. Within 60 days following the provision of service to 1,000 subscribers, the operator of each such system shall file a notice to that effect with the Commission, and serve a copy of that notice on every television station that would be entitled to exercise network non-duplication protection against it.
47 CFR Section 76.105(d) requires that in the event the exclusivity specified in Section 76.94(a) has been limited or has ended prior to the time specified in the notice, the distributor or broadcaster who has supplied the original notice shall, as soon as possible, inform each cable television system operator that has previously received the notice of all changes from the original notice. In the event the original notice specified contingent dates on which exclusivity is to begin and/or end, the distributor or broadcaster shall, as soon as possible, notify the cable television system operator of the occurrence of the relevant contingency. Notice to be furnished “as soon as possible” under this subsection shall be furnished by telephone, telegraph, facsimile, overnight mail or other similar expedient means.
47 CFR Section 76.106(b) states that the provisions of Sections 76.101 through 76.105 (including the notification provisions of Section 76.105) shall not apply to a cable system serving fewer than 1,000 subscribers. Within 60 days following the provision of service to 1,000 subscribers, the operator of each such system shall file a notice to effect with the Commission, and serve a copy of that notice on every television station that would be entitled to exercise syndicated exclusivity protection against it.
47 CFR Section 76.1609 states that network non-duplication provisions of Sections 76.92 through 76.94 shall not apply to cable systems serving fewer than 1,000 subscribers. Within 60 days following the provision of service to 1,000 subscribers, the operator of each system shall file a notice to that effect with the Commission, and serve a copy of that notice on every television station that would be entitled to exercise network non-duplication or syndicated exclusivity protection against it.
47 CFR Section 76.1708 requires that the operator of every cable television system shall maintain for public inspection the designation and location of its principal headend. If an operator changes the designation of its principal headend, that new designation must be included in its public file.
47 CFR Section 76.1709(a) states effective June 17, 1993, the operator of every cable television system shall maintain for public inspection a file containing a list of all broadcast television stations carried by its system in fulfillment of the must-carry requirements pursuant to 47 CFR Section 76.56. Such list shall include the call sign; community of license, broadcast channel number, cable channel number, and in the case of a noncommercial educational broadcast station, whether that station was carried by the cable system on March 29, 1990.
47 CFR Sections 76.1614 and 1709(c) states that a cable operator shall respond in writing within 30 days to any written request by any person for the identification of the signals carried on its system in fulfillment of the requirements of 47 CFR Section 76.56.
47 CFR Section 76.1620 states that if a cable operator authorizes subscribers to install additional receiver connections, but does not provide the subscriber with such connections, or with the equipment and materials for such connections, the operator shall notify such subscribers of all broadcast stations carried on the cable system which cannot be viewed via cable
47 CFR 73.673 states each commercial television broadcast station licensee must provide information identifying programming specifically designed to educate and inform children to publishers of program guides. Such information must include an indication of the age group for which the program is intended.
These requirements are intended to provide greater clarity about broadcasters' obligations under the Children's Television Act (CTA) of 1990 to air programming “specifically designed” to serve the educational and informational needs of children and to improve public access to information about the availability of these programs. These requirements provide better information to the public about the shows broadcasters air to satisfy their obligation to provide educational and informational programming under the Children's Television Act.
(1) Agency FAIR Act Report/Recommendation.
(2) Docket No. 07-05 KEI Enterprises dba KEI Logix v. Greenwest Activewear, Inc.
(1) Direction to Staff Regarding Budget Hearing Committee Requests.
(2) Show Cause Order re OTI Licensing Matter.
(3) Agreement No. 201178—Los Angeles/Long Beach Port/Terminal Operator Administration and Implantation Agreement and Agreement No. 201170—Los Angeles and Long Beach Port Infrastructure and Environmental Programs.
(4) Export Cargo Issues.
(5) Internal Administrative Practices and Personnel Matters.
Federal Trade Commission (“FTC” or “Commission”).
Notice.
The Federal Trade Commission is seeking public comments on its proposal to conduct consumer research on parental use of the Motion Picture Association of America (“MPAA”) movie rating information as it appears on DVD packaging for home video releases of rated motion pictures. The FTC is also seeking comment on a related proposal to conduct consumer research on parental attitudes toward the marketing of unrated DVD versions of rated motion pictures. To examine both issues, the Commission intends to conduct surveys of parents who have one or more children ages 7 to 16, and who have bought or rented a movie on DVD within the past year. 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”).
Comments must be filed by August 4, 2008.
Interested parties are invited to submit written comments. Comments should refer to “DVD Rating Symbol Study: FTC Matter No. P994511,” 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-135 (Annex J), 600 Pennsylvania Ave., NW, Washington, DC 20580. 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. Moreover, because paper mail in the Washington area and at the Agency is subject to delay, please consider submitting your comments in electronic form, as prescribed below. If, however, 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.”
Comments filed in electronic form should be submitted by following the instructions on the web-based form at
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 website, to the extent practicable, at
Requests for additional information should be addressed to Michelle K. Rusk (202) 326-3148, or Keith R. Fentonmiller (202) 326-2775, Attorneys, Division of Advertising Practices, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue, N.W., Washington, DC 20580.
In September 2000, the Commission issued a report requested by the President and the Congress entitled, “Marketing Violent Entertainment to Children: A Review of Self-Regulation and Industry Practices in the Motion Picture, Music Recording & Electronic Game Industries” (hereafter “2000 Report”).
As one aspect of its ongoing monitoring, the Commission has examined the disclosure of MPAA ratings and rating reasons on DVD packaging for home video releases of MPAA-rated motion pictures. The MPAA Advertising Handbook requires that “all packaging of rated home video releases must carry the rating of the motion picture and the rating reasons,” and that “the rating symbol and specific rating reasons must be clearly and legibly displayed.”
In the April 2007 Report, the Commission also reviewed, for the first time, the movie industry’s practice of releasing unrated DVD versions of movies that were rated R when they were first released in theaters.
The FTC is seeking public comments on its proposal to examine, through consumer research, two issues relating to MPAA ratings and DVD home video releases: (1) how the placement and size of MPAA rating information on DVD packaging for rated movies affects parental use of the rating; and (2) parental awareness and attitudes about the marketing of unrated DVDs. The Commission will seek OMB clearance under the PRA, 44 U.S.C. 3501-3521, before engaging in the proposed consumer research.
Under the PRA, 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 grant the clearance for this consumer survey.
The FTC invites comments on: (1) whether the required 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;
All comments should be filed as prescribed in the
The FTC proposes to conduct a mall intercept study, using an experimental design with two treatment conditions, to assess how the placement and size of MPAA rating information on DVD packaging affects parental use of the rating. The FTC proposes to conduct a telephone survey to assess parental awareness and attitudes about the marketing of unrated DVDs. The methodologies for both consumer research proposals are detailed below.
A mall intercept study is the most appropriate methodology for assessing differences in the effect of placement and size of the MPAA rating because it allows respondents to physically examine samples of DVD packaging. The study will have an experimental design with respondents randomly assigned to one of two treatment conditions. The study will analyze differences in response between the two groups.
The FTC proposes to conduct the study in multiple locations across the country using a random sample of 400 adult respondents who are parents of one or more children ages 7 to 16, and who have bought or rented a DVD movie for their children within the past year. The study will be divided into two groups of 200. Each group will be given the opportunity to examine a DVD package for a movie that has been rated either PG-13 or R due in part to violent content.
The information from the questionnaires will be collected on a voluntary basis, and the identities of the respondents will remain confidential. Subject to OMB approval for the collection of information, the FTC plans to contract with a consumer research firm that will identify respondents, conduct a pretest, refine the questionnaire, and conduct the study. The results will assist the FTC in determining how easy or difficult it is for parents to find and use MPAA rating information on DVD packaging and whether changes in presentation of the rating information will significantly improve the ease of use.
To assess parental awareness and attitudes about the marketing of unrated DVDs, the FTC plans to conduct a national telephone survey of 1,000 adult respondents who are parents of one or more children ages 7 to 16, and who have bought or rented a DVD movie for their children within the past year. This approach will allow the agency to have a sufficiently large and representative sample of the population to accurately assess parents’ awareness and attitudes. Respondents will be asked a combination of open-ended and closed-ended questions. The questions will measure the level of parents’ awareness of the marketing of unrated DVDs and assess whether parents understand that unrated DVD movies may contain content that could result in a more restrictive rating than the rating assigned to the theater version of the same movie. Additional questions will be designed to assess parents’ attitudes about the marketing of unrated DVDs, including how the absence of a rating affects their decision whether to allow their children to watch the movie. Finally, respondents will be asked questions about what policy they expect DVD retailers to apply to the sale of unrated DVDs directly to children.
As with the mall intercept study, the information from the telephone survey questionnaires will be collected on a voluntary basis, and the identities of the respondents will remain confidential. Subject to OMB approval for the collection of information, the FTC plans to contract with a consumer research firm that will identify respondents, conduct a pretest of the survey, refine the questionnaire, and conduct the survey. The results of the telephone survey will assist the FTC in assessing how the marketing of unrated DVDs impacts parents’ decisions about what movies they will allow their children to watch. It will also help the FTC in forming recommendations about retail policies for the sale of unrated DVDs directly to children.
For the mall intercept study and a pretest of the study, the contractor will screen respondents to identify parents with children ages 7 to 16 who have bought or rented a DVD movie for their child within the past year. Allowing for non-response, the FTC staff estimates that the screening questions will be asked of approximately 2,000 respondents in order to obtain a large enough sample for the study and the pretest. The FTC staff estimates that screening will require no more than two minutes per person for a maximum hour burden of 67 hours (2,000 respondents 2 minutes for each).
The FTC intends to pretest the questionnaire on 15 parents to ensure that all questions are easily understood. The FTC expects that the pretest will require no more than 10 minutes per person. The hours burden imposed by the pretest will be approximately 2.5 hours (15 respondents 10 minutes for each).
The FTC staff estimates that the study of 400 respondents also will require no more than 10 minutes per person or, cumulatively, 67 hours (400 respondents 10 minutes for each).
Thus, the estimated total hours burden attributable to the mall intercept study is 136.5 hours (67 + 2.5 + 67).
For the telephone survey and a pretest of the survey, the contractor will apply the same screening threshold, identifying respondents who are parents with children ages 7 to 16 who have bought or rented a DVD movie for their child within the past year. Allowing for non-response, the FTC staff estimates that the screening questions will be asked of approximately 9,000 respondents in order to obtain a large enough sample for the survey and the pretest. The FTC staff estimates that screening will require no more than one minute per person for a maximum hour burden of 150 hours (9,000 respondents 1 minute for each).
The FTC intends to pretest the questionnaire on 100 parents to ensure that all questions are easily understood. The FTC expects that the pretest will require no more than 5 minutes per
The FTC staff estimates that the survey of 1,000 respondents also will require no more than 5 minutes per person or 83.5 hours (1,000 respondents 5 minutes for each).
Thus, the estimated total hours burden attributable to the telephone survey research is 242 hours (150 + 8.5 + 83.5).
The combined total hours burden attributable to both research projects is 378.5 hours (242 + 136.5).
The cost per respondent should be negligible. Participation is voluntary and will not require any labor expenditures by respondents nor capital, start-up, operation, maintenance, or other similar costs.
Department of Health and Human Services, Office of the Secretary.
Notice.
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services is hereby giving notice that the National Biodefense Science Board (NBSB) will be holding a meeting. The meeting is open to the public.
The meeting will be held on June 18, 2008, from 8:30 a.m. to 5 p.m.
The Sheraton National Hotel, 900 S. Orme Street, Arlington, VA 22204. Phone: 703-521-1900.
CAPT Leigh A. Sawyer, D.V.M., M.P.H., Executive Director, National Biodefense Science Board, Office of the Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services, 200 Independence Ave SW., Room 638G, Washington, DC 20201; 202-205-3815; fax: 202-205-0613; e-mail address:
Pursuant to section 319M of the Public Health Service Act (42 U.S.C. 247d-7f) and section 222 of the Public Health Service Act (42 U.S.C. 217a), the Department of Health and Human Services established the National Biodefense Science Board.
The Board shall provide expert advice and guidance to the Secretary on scientific, technical, and other matters of special interest to the Department of Health and Human Services regarding current and future chemical, biological, nuclear, and radiological agents, whether naturally occurring, accidental, or deliberate. The Board may also provide advice and guidance to the Secretary on other matters related to public health emergency preparedness and response.
Topics to be discussed include updates from the Pandemic Influenza Working Group, the Disaster Medicine Working Group, the Markets and Sustainability Working Group, and the U.S. Medical Countermeasure Research and Development Processes for Chemical, Biological, Radiological and Nuclear Agents Working Group. Additionally, the NBSB will discuss preparedness and planning issues related to at-risk populations and pandemic influenza , consider issues related to medical response and preparedness for radiological and nuclear events, and receive an update on the activities of the Homeland Security Presidential Directive #21, Federal Biosurveillance Working Group. The NBSB will also receive a briefing on issues related to the Department of Health and Human Services development of MedKits. This agenda is subject to change as priorities dictate. A tentative schedule will be made available on June 6, 2008 at the NBSB Web site,
Any member of the public interested in presenting oral comments at the meeting may notify the Contact person listed on this notice by June 11, 2008. Interested individuals and representatives of an organization may submit a letter of intent and a brief description of the organization represented. In addition, any interested person may file written comments with the committee. All written comments must be received prior to June 11, 2008 and should be sent by e-mail with “NBSB Public Comment” as the subject line or by regular mail to the Contact person listed above. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the designated contact person.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the
Submit written or electronic comments on the collection of information by August 4, 2008.
Submit electronic comments on the collection of information to
Denver Presley, Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472.
Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the
With respect to the following collection of information, FDA invites comments on these 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.
With passage of the Animal Drug Availability Act, Congress enacted legislation establishing a new class of restricted feed use drugs called Veterinary Feed Directive (VFD drugs). The VFD class of drugs may be distributed without involving State pharmacy laws. Although controls on the distribution and use of VFD drugs are similar to controls for prescription drugs regulated under section 503(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 503(f), the implementing VFD regulation under section 558.6 (21 CFR 558.6) is tailored to the unique circumstances relating to the distribution of medicated feeds. The content of the VFD is spelled out in the regulation. All distributors of medicated feed containing VFD drugs must notify FDA of their intent to distribute, and the distribution records of all medicated feeds containing VFD must be maintained. The VFD regulation ensures the protection of the public health while enabling animal producers to obtain and use needed drugs as efficiently and cost-effectively as possible.
FDA estimates the burden of this collection of information as follows:
The estimate of the times required for record preparation and maintenance is based on agency communication with industry and agency records and experience.
Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at
Food and Drug Administration, HHS.
Notice.
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
On July 23, 2008, the committee will do the following: (1) Receive and discuss presentations from the Office of Generic Drugs (OGD) on the bioequivalence methods for locally acting drugs that treat gastrointestinal (GI) conditions, (2) receive and discuss presentations from OGD on the use of inhaled corticosteroid dose-response as a means to establish bioequivalence of inhalation drug products, and (3) receive and discuss presentations from OPS on the drug classification of orally disintegrating tablets (ODT) as a separate dosage form, and the need for subsequent guidance on expectations and recommendations that would be required for applications proposing the dosage form.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at
Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Diem-Kieu Ngo at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Food and Drug Administration, HHS.
Notice.
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at
Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Nicole Vesely at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Notice; correction.
The Indian Health Service published a document in the
Christina Rouleau, Office of Management Services, Indian Health Service, 801 Thompson Avenue, Suite 450, Rockville, MD 20852, Telephone (301) 443-5938. (This is not a toll-free number.)
In the
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, June 30, 2008, 8 a.m. to July 1, 2008, 5 p.m., Doubletree Hotel, 1515 Rhode Island Avenue, NW., Washington, DC 20005, which was published in the
The meeting will be held one day only, June 30, 2008. The meeting time and location remain the same. The meeting is closed to the public.
Notice is hereby given of a change in the meeting of the Biobehavioral Mechanisms of Emotion, Stress and Health Study Section, June 5, 2008, 8 a.m. to June 6, 2008, 5 p.m., The Hotel Lombardy, 2019 Pennsylvania Avenue, NW., Washington, DC 20006, which was published in the
The meeting will be held one day only, June 5, 2008, from 8 a.m. to 6 p.m. The meeting location remains the same. The meeting is closed to the public.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Notice is hereby given of the cancellation of the Center for Scientific Review Special Emphasis Panel, June 3, 2008, 3 p.m. to June 3, 2008, 4 p.m.,
The meeting was cancelled due to administration problems.
Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, May 28, 2008, 1 p.m. to May 28, 2008, 5 p.m., National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 which was published in the
The meeting will be held June 12, 2008. The meeting time and location remains the same. The meeting is closed to the public.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the urgent need to meet timing limitations imposed by the intramural research review cycle.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This meeting is being published less than 15 days prior to the meeting due to timing limitations imposed by administrative matters.
National Protection and Programs Directorate, Office of Infrastructure Protection, Infrastructure Information Collection Division, DHS.
60-Day Notice and request for comments.
The Department of Homeland Security (DHS) invites the general public and other federal agencies the opportunity to comment on new information collection request 1670—NEW, Constellation/Automated Critical Asset Management System (C/ACAMS) Functional Survey. As required by the Paperwork Reduction Act of 1995, (Pub. L. 104-13, 44 U.S.C. chapter 35) as amended by the Clinger-Cohen Act (Pub. L. 104-106), DHS is soliciting comments for this collection.
Comments are encouraged and will be accepted until August 4, 2008. This process is conducted in accordance with 5 CFR 1320.1.
Comments and questions about this Information Collection Request should be forwarded to the Department of Homeland Security, National Protection and Programs Directorate, Infrastructure Protection, Infrastructure Information Collection Division, Attn: Veronica Heller, Team Lead, Ballston One, 5th Floor, 4601 N. Fairfax Dr., Arlington, VA 22203.
Department of Homeland Security, National Protection and Programs Directorate, Infrastructure Protection, Attn: Veronica Heller,
The Office of Management and Budget is particularly interested in comments that:
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, including the validity of the methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to be collected; and
4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses.
Science and Technology Directorate, DHS.
Notice of public meeting.
The Department of Homeland Security's (DHS) Office for Interoperability and Compatibility (OIC) will hold a public meeting of its Project 25 (P25) Compliance Assessment Program (CAP) Governing Board (GB). The P25 CAP GB is composed of public sector officials who represent the collective interest of organizations that procure P25 equipment. The purpose of the meeting is to review and approve the proposed Compliance Assessment Bulletin(s).
The P25 CAP GB will not receive public comments during the session. DHS OIC will post details of the meeting, including the agenda and instructions on how to provide comments to the GB, ten business days in advance of the meeting at
The meeting will take place on Wednesday, June 25, 2008, from 2 p.m. to 3 p.m. (EST).
The session will take place via conference call. To listen, please send an e-mail to
Luke Klein-Berndt, Department of Homeland Security, Science and Technology Directorate, Office for Interoperability and Compatibility, Washington Navy Yard, 245 Murray Lane, SW., Building #410, Washington, DC 20528. Telephone: (202) 254-5332. E-mail:
Emergency responders—emergency medical services, fire personnel, and law enforcement officers—need to seamlessly exchange communications across disciplines and jurisdictions to successfully respond to day-to-day incidents and large-scale emergencies. P25 focuses on developing standards that allow radios and other components to interoperate, regardless of the manufacturer. In turn, these standards enable emergency responders to exchange critical communications with other disciplines and jurisdictions.
An initial goal of P25 is to specify formal standards for interfaces between the components of a land mobile radio (LMR) system; LMR systems are commonly used by emergency responders in portable handheld and mobile vehicle-mounted devices. Although formal standards are being developed, no process is currently in place to confirm that equipment advertised as P25-compliant meets all aspects of P25 standards.
To address discrepancies between P25 standards and industry equipment, Congress passed legislation calling for the creation of the P25 CAP. The P25 CAP is a partnership of the DHS Command, Control and Interoperability Division; the Department of Commerce's National Institute of Standards and Technology; industry; and the emergency response community.
The P25 CAP works to establish a process for ensuring that equipment complies with P25 standards and can interoperate across manufacturers. By providing manufacturers with a method to test their equipment for compliance with P25 standards, the P25 CAP helps emergency response officials make informed purchasing decisions. The program's initial focus is on the Common Air Interface, which allows for over-the-air compatibility between mobile and portable radios and tower equipment.
For more information on the program, please review OIC's
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of Arkansas (FEMA-1758-DR), dated May 20, 2008, and related determinations.
Peggy Miller, Disaster Assistance Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646-2705.
The notice of a major disaster declaration for the State of Arkansas is hereby amended to include the following areas among those areas determined to have been adversely affected by the catastrophe declared a
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of Maine (FEMA-1755-DR), dated May 9, 2008, and related determinations.
Peggy Miller, Disaster Assistance Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646-2705.
The notice of a major disaster declaration for the State of Maine 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 May 9, 2008.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of Oklahoma (FEMA-1756-DR), dated May 14, 2008, and related determinations.
Peggy Miller, Disaster Assistance Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646-2705.
The notice of a major disaster declaration for the State of Oklahoma is hereby amended to include the following areas among the areas determined to have been adversely affected by the catastrophe declared a major disaster by the President in his declaration of May 14, 2008.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of Oklahoma (FEMA-1756-DR), dated May 14, 2008, and related determinations.
Peggy Miller, Disaster Assistance Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646-2705.
The notice of a major disaster declaration for the State of Oklahoma 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 14, 2008.
Craig, Latimer, and Ottawa Counties for Public Assistance, including direct Federal assistance, (already designated for Individual Assistance.)
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of a major disaster for the State of Colorado (FEMA-1762-DR), dated May 26, 2008, and related determinations.
Peggy Miller, Disaster Assistance Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646-2705.
Notice is hereby given that, in a letter dated May 26, 2008, 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 Colorado resulting from severe storms and tornadoes on May 22, 2008, 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). Therefore, I declare that such a major disaster exists in the State of Colorado.
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 in the designated areas, Hazard Mitigation throughout the State, and any other forms of assistance under the Stafford Act that you deem appropriate. Consistent with the requirement that Federal assistance be supplemental, any Federal funds provided under the Stafford Act for Hazard Mitigation and Other Needs Assistance will be limited to 75 percent of the total eligible costs. If Public Assistance is later requested and warranted, Federal funds provided under that program also will be limited to 75 percent of the total eligible costs, except for any particular projects that are eligible for a higher Federal cost-sharing percentage under the FEMA Public Assistance Pilot Program instituted pursuant to 6 U.S.C. 777.
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 Administrator, under Executive Order 12148, as amended, Kenneth R. Tingman of FEMA is appointed to act as the Federal Coordinating Officer for this declared disaster.
The following areas of the State of Colorado have been designated as adversely affected by this declared major disaster:
Larimer and Weld Counties for Individual Assistance.
All counties within the State of Colorado are eligible to apply for assistance under the Hazard Mitigation Grant Program.
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of a major disaster for the State of Georgia (FEMA-1761-DR), dated May 23, 2008, and related determinations.
Peggy Miller, Disaster Assistance Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646-2705.
Notice is hereby given that, in a letter dated May 23, 2008, 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 Georgia resulting from severe storms and tornadoes during the period of May 11-12, 2008, 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). Therefore, I declare that such a major disaster exists in the State of Georgia.
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 Public Assistance in the designated areas and Hazard Mitigation throughout the State. Consistent with the requirement that Federal assistance be supplemental, any Federal funds provided under the Stafford Act for Hazard Mitigation and Other Needs Assistance will be limited to 75 percent of the total eligible costs. Federal funds provided under the Stafford Act for Public Assistance also will be limited to 75 percent of the total eligible costs, except for any particular projects that are eligible for a higher Federal cost-sharing percentage under the FEMA Public Assistance Pilot Program instituted pursuant to 6 U.S.C. 777.
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 Administrator, under Executive Order 12148, as amended, Jeffery L. Bryant, of FEMA, is appointed to act as the Federal Coordinating Officer for this declared disaster.
The following areas of the State of Georgia have been designated as adversely affected by this declared major disaster:
Bibb, Carroll, Douglas, Emanuel, Jefferson, Jenkins, Johnson, Laurens, McIntosh, and Twiggs Counties for Individual Assistance.
Bibb, Carroll, Crawford, Emanuel, Glynn, Jefferson, Jenkins, Johnson, Laurens, McIntosh, Treutlen, Twiggs, and Wilkinson Counties for Public Assistance.
All counties within the State of Georgia are eligible to apply for assistance under the Hazard Mitigation Grant Program.
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of a major disaster for the State of Iowa (FEMA-1763-DR), dated May 27, 2008, and related determinations.
Peggy Miller, Disaster Assistance Directorate, Federal Emergency Management Agency, Washington, DC 20472, (202) 646-2705.
Notice is hereby given that, in a letter dated May 27, 2008, 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 Iowa resulting from severe storms, tornadoes, and flooding beginning on May 25, 2008, 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). Therefore, I declare that such a major disaster exists in the State of Iowa.
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 assistance for emergency protective measures (Category B), limited to direct Federal assistance, under the Public Assistance program in the designated areas; Hazard Mitigation throughout the State; and any other forms of assistance under the Stafford Act that you deem appropriate subject to completion of Preliminary Damage Assessments (PDAs), unless you determine that the incident is of such unusual severity and magnitude that PDAs are not required to determine the need for supplemental Federal assistance pursuant to 44 CFR 206.33(d).
Consistent with the requirement that Federal assistance be supplemental, any Federal funds provided under the Stafford Act for Hazard Mitigation, and Other Needs Assistance will be limited to 75 percent of the total eligible costs. Federal funds provided under the Stafford Act for Public Assistance also will be limited to 75 percent of the total eligible costs, except for any particular projects that are eligible for a higher Federal cost-sharing percentage under the FEMA Public Assistance Pilot Program instituted pursuant to 6 U.S.C. 777.
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 Administrator, Department of Homeland Security, under Executive Order 12148, as amended, William L. Vogel, 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 Iowa to have been affected adversely by this declared major disaster:
Butler County for Individual Assistance.
Butler County for emergency protective measures (Category B), limited to direct Federal assistance, under the Public Assistance program.
All counties within the State of Iowa are eligible to apply for assistance under the Hazard Mitigation Grant Program.
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of a major disaster for the State of Mississippi (FEMA-1764-DR), dated May 28, 2008, and related determinations.
Peggy Miller, Disaster Assistance Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646-2705.
Notice is hereby given that, in a letter dated May 28, 2008, 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 Mississippi resulting from severe storms and tornadoes on April 4, 2008, 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). Therefore, I declare that such a major disaster exists in the State of Mississippi.
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 Public Assistance in the designated areas and Hazard Mitigation throughout the State. Consistent with the
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 Administrator, under Executive Order 12148, as amended, Michael L. Parker, of FEMA is appointed to act as the Federal Coordinating Officer for this declared disaster.
The following areas of the State of Mississippi have been designated as adversely affected by this declared major disaster:
Hinds County for Individual Assistance and Public Assistance.
All counties within the State of Mississippi are eligible to apply for assistance under the Hazard Mitigation Grant Program.
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of a major disaster for the State of Missouri (FEMA-1760-DR), dated May 23, 2008, and related determinations.
Peggy Miller, Disaster Assistance Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646-2705.
Notice is hereby given that, in a letter dated May 23, 2008, 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 Missouri resulting from severe storms and tornadoes during the period of May 10-11, 2008, 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). Therefore, I declare that such a major disaster exists in the State of Missouri.
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 in the designated areas and Hazard Mitigation throughout the State. Consistent with the requirement that Federal assistance be supplemental, any Federal funds provided under the Stafford Act for Hazard Mitigation and Other Needs Assistance will be limited to 75 percent of the total eligible costs. If Public Assistance is later warranted, Federal funds provided under that program also will be limited to 75 percent of the total eligible costs, except for any particular projects that are eligible for a higher Federal cost-sharing percentage under the FEMA Public Assistance Pilot Program instituted pursuant to 6 U.S.C. 777.
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 Administrator, under Executive Order 12148, as amended, Michael L. Karl, of FEMA is appointed to act as the Federal Coordinating Officer for this declared disaster.
The following areas of the State of Missouri have been designated as adversely affected by this declared major disaster:
Barry, Jasper, and Newton Counties for Individual Assistance.
All counties within the State of Missouri are eligible to apply for assistance under the Hazard Mitigation Grant Program.
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of a major disaster for the State of South Dakota (FEMA-1759-DR), dated May 22, 2008, and related determinations.
Peggy Miller, Disaster Assistance Directorate, Federal Emergency
Notice is hereby given that, in a letter dated May 22, 2008, 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 South Dakota resulting from a severe winter storm and record and near record snow during the period of May 1-2, 2008, 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). Therefore, I declare that such a major disaster exists in the State of South Dakota.
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; assistance for emergency protective measures (Public Assistance Category B), including snow removal for any continuous 48-hour period during or proximate to the incident period in the designated areas; Hazard Mitigation throughout the State; and any other forms of assistance under the Stafford Act that you deem appropriate.
Consistent with the requirement that Federal assistance be supplemental, any Federal funds provided under the Stafford Act for Hazard Mitigation will be limited to 75 percent of the total eligible costs. Federal funds provided under the Stafford Act for Public Assistance also will be limited to 75 percent of the total eligible costs, except for any particular projects that are eligible for a higher Federal cost-sharing percentage under the FEMA Public Assistance Pilot Program instituted pursuant to 6 U.S.C. 777. If Other Needs Assistance under Section 408 of the Stafford Act is later requested and warranted, Federal funding under that program also will 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 Administrator, under Executive Order 12148, as amended, Tony Russell, of FEMA, is appointed to act as the Federal Coordinating Officer for this declared disaster.
The following areas of the State of South Dakota have been designated as adversely affected by this declared major disaster:
Bennett, Butte, Harding, Jackson, and Perkins Counties for Public Assistance.
Butte, Harding, and Lawrence Counties for emergency protective measures (Category B), including snow removal assistance, under the Public Assistance program for any continuous 48-hour period during or proximate to the incident period.
All counties within the State of South Dakota are eligible to apply for assistance under the Hazard Mitigation Grant Program.
Minerals Management Service (MMS), Interior.
Notice of Renewal of the Outer Continental Shelf Policy Committee.
Following consultation with the General Services Administration, notice is hereby given that the Secretary of the Interior (Secretary) is renewing the OCS Policy Committee.
The OCS Policy Committee will provide advice to the Secretary through the Director of the Minerals Management Service related to the discretionary functions of the Bureau under the OCS Lands Act and related statutes. The Committee will review and comment on all aspects of leasing, exploration, development and protection of OCS resources and provide a forum to convey views representative of coastal states, local government, offshore industries, environmental community, other users of the offshore, and the interested public.
Ms. Jeryne Bryant, Minerals Management Service, Offshore Minerals Management, Herndon, Virginia 20170-4817, telephone (703) 787-1213.
I hereby certify that the renewal of the OCS Policy Committee is in the public interest in connection with the performance of duties imposed on the Department of the Interior by 43 U.S.C. 1331
Bureau of Indian Affairs, Interior.
Notice of rate adjustments.
The Bureau of Indian Affairs (BIA) owns or has an interest in irrigation projects and facilities located on various Indian reservations throughout the United States. We are authorized to establish rates to recover the costs to administer, operate, maintain, and rehabilitate those facilities. We are notifying you that we have adjusted the irrigation assessment rates at several of our irrigation projects and facilities for operation and maintenance.
For details about a particular BIA irrigation project or facility, please use the tables in
A Notice of Proposed Rate Adjustment was published in the
For the Fort Belknap Indian Irrigation Project, the BIA, in consultation with the Gros Ventre and Assiniboine Tribes and Project water users, has deferred the rate increase for 2008.
Written comments were received for the proposed rate adjustments for the Blackfeet Irrigation Project, Fort Belknap Irrigation Project, and the Wind River Irrigation Project.
Individuals and entities commenting on the proposed rates for 2008 were concerned with one or more of the following issues: (1) How funds are expended for operation and maintenance (O&M) costs; (2) how rate increases are justified and communicated to water users; (3) how rate increases impact the local agricultural economy and individual land owners; (4) the role of the BIA's Central Office in managing projects and the burden of federal regulations; (4) land owners without access to project water being assessed irrigation charges; (5) the BIA's non-delivery of water to water users with outstanding O&M charges; and (6) the BIA's trust responsibility for projects. The following comment is specific to the Wind River Irrigation Project: users assert that O&M rates should not be adjusted until a study of the project's irrigable and assessable acreage is completed.
The BIA considers the following expenses when determining an irrigation project's budget: project personnel costs; materials and supplies; vehicle and equipment repairs; equipment; capitalization expenses; acquisition expenses; rehabilitation costs; maintenance of a reserve fund for contingencies or emergencies; and other expenses that we determine are necessary to properly operate and maintain an irrigation project.
One common misconception water users have is that all salary costs are administrative. Only a portion of each project's budget is for administrative costs. The administrative costs for a project includes office costs, office staff (accounting and clerical), and a portion of the project manager's salary. Non-administrative costs are the cost to operate and maintain the project or facility. Operation and maintenance workers perform operation and maintenance work, thus their salaries are considered operation and maintenance costs, not administrative costs. All projects need essential personnel to operate and maintain the project, including a project manager, accounting staff, and irrigation system operators (ditchriders).
BIA policy states that irrigation project managers are required to meet, at a minimum, twice annually with their water users—once at the end of the irrigation season and once before the next season. For projects that operate year-round, project managers will determine the best schedule for holding these meetings. At these meetings, irrigation staff will provide water users with information regarding project operations—including budget plans and actual annual expenditures—and obtain feedback and input from water users.
Individuals concerned with the BIA's management of its projects and its O&M rates may review the BIA's records at their convenience. The BIA's project budget estimates and expense records are available for review by stakeholders or interested parties. Stakeholders (water users, land owners, or tribes) can review these records during normal business hours at the individual agency office. Alternatively, stakeholders or interested parties may request project records under the Freedom of Information Act (FOIA). The BIA will provide copies of such records to the requesting party in accordance with FOIA.
To review or obtain copies of project records, stakeholders and interested parties should contact the BIA representative at the specific project or facility serving them, using the tables in the
The BIA's projects are important economic contributors to the local communities they serve. These projects contribute millions of dollars in crop value annually. Historically, the BIA tempered irrigation rate increases to demonstrate sensitivity to the economic impact on water users. This past practice resulted in a rate deficiency at some irrigation projects. The BIA does not have discretionary funds to subsidize irrigation projects. Funding to operate and maintain these projects needs to come from revenues from the water users served by those projects.
Over the past several years, the BIA's irrigation program has been the subject of several Office of Inspector General (OIG) and GAO audits. In the most recent OIG audit, No. 96-I-641, March 1996, the OIG concluded: “Operation and maintenance revenues were insufficient to maintain the projects, and some projects had deteriorated to the extent that their continued capability to deliver water was in doubt. This occurred because operation and maintenance rates were not based on the full cost of delivering irrigation water, including the costs of systematically rehabilitating and replacing project facilities and equipment, and because project personnel did not seek regular rate increases to cover the full cost of project operation.” A previous OIG audit performed on one of the BIA's largest irrigation projects, the Wapato Indian Irrigation Project, No. 95-I-1402, September 1995, reached the same conclusion.
To address the issues noted in these audits, the BIA must systematically review and evaluate irrigation assessment rates and adjust them, when necessary, to reflect the full costs to properly operate and perform all appropriate maintenance on the irrigation project or facility infrastructure to ensure safe and reliable operation. If this review and adjustment is not accomplished, a rate deficiency can accumulate. Rate deficiencies force the BIA to raise irrigation assessment rates in larger increments over shorter periods of time than would have been otherwise necessary.
The BIA must follow Federal regulations as it operates and maintains the projects under its ownership or control. Specifically, the BIA must follow Federal guidelines in hiring and compensating personnel to operate and manage irrigation projects. The BIA sets rates in accordance with the criteria identified above. The BIA Central Office does not unilaterally impose rate increases on projects. The BIA is reviewing various options for cost savings, including turning over projects or sections of projects to water users and sharing personnel between or among projects.
As mentioned above, OIG and GAO performed audits on the BIA irrigation program and noted that the BIA has not set irrigation assessment rates at levels high enough to operate and maintain its irrigation projects. The BIA has been increasing rates to address this concern. Because rates were low for many years, numerous maintenance items were deferred. At some projects, this deferral resulted in the BIA's inability to deliver water to all users. To assist water users in this regard, the BIA updated its Irrigation Operations and Maintenance regulations, 25 CFR part 171, to allow a water user to apply for a waiver of irrigation assessment charges if the BIA is incapable of delivering water to that water user. To apply for this waiver, a water user must meet with local project staff.
The BIA's irrigation regulations, 25 CFR part 171, require the BIA to withhold irrigation services from users who have delinquent debt with the BIA, including balances that have been referred to the United States Treasury.
The BIA disagrees that increasing O&M rates for projects violates any trust duty. The BIA has no trust obligation to operate and maintain irrigation projects.
The BIA levies assessments on lands to which its project is authorized and capable of delivering water. Thus, a parcel's irrigation history is immaterial to whether it is subject to an irrigation assessment. The Secretary may deem lands within a project non-assessable, in which case those lands may be removed from the project—permanently or temporarily—with the landowner's consent. 25 U.S.C. sections 389a, 389b. The redesignation study will not determine what O&M assessment the lands could support. The study only determines if the lands are irrigable and if they should remain assessable. The overall O&M assessment for a project is based on its total assessable acres. If the redeisgnation study recommends removing assessable acres from the project, the O&M assessment rate would increase significantly for those acres remaining in the project. Until such time as the land re-designation study referenced by this commenter is finished, individual users may apply for an annual assessment waiver under 25 CFR part 171.
No.
This notice affects you if you own or lease land within the assessable acreage of one of our irrigation projects, or you have a carriage agreement with one of our irrigation projects.
You can contact the appropriate office(s) stated in the tables for the irrigation project that serves you, or you can use the Internet site for the Government Printing Office at
Our authority to issue this notice is vested in the Secretary of the Interior by 5 U.S.C. section 301 and the Act of August 14, 1914 (38 Stat. 583; 25 U.S.C. 385). The Secretary has in turn delegated this authority to the Assistant Secretary—Indian Affairs under Part 209, Chapter 8.1A, of the Department of the Interior's Departmental Manual.
The following tables are the regional and project/agency contacts for our irrigation projects and facilities.
The rate table below contains the current rates for all of our irrigation projects where we recover our costs for operation and maintenance. The table also contains the final rates for the 2008 season and subsequent years where applicable. An asterisk immediately following the name of the project notes that the BIA adjusted that project's rates for 2009.
To fulfill its consultation responsibility to tribes and tribal organizations the BIA communicates, coordinates, and consults on a continuing basis with these entities on issues of water delivery, water availability, and costs of administration, operation, maintenance, and rehabilitation of projects that concern them. This is accomplished at the individual projects by Project, Agency, and Regional representatives, as appropriate, in accordance with local protocol and procedures. This notice is one component of the BIA's overall coordination and consultation process to provide notice to, and request comments from, these entities when the BIA adjusts irrigation rates.
The rate adjustments will have no adverse effects on energy supply, distribution, or use (including a shortfall in supply, price increases, and increase use of foreign supplies) should the proposed rate adjustments be implemented. This is a notice for rate adjustments at BIA-owned and operated projects, except for the Fort Yuma
These rate adjustments are not a significant regulatory action and do not need to be reviewed by the Office of Management and Budget under Executive Order 12866.
This rate making is not a rule for the purposes of the Regulatory Flexibility Act because it is “a rule of particular applicability relating to rates.” 5 U.S.C. 601(2).
These rate adjustments impose no unfunded mandates on any governmental or private entity and are in compliance with the provisions of the Unfunded Mandates Reform Act of 1995.
The Department has determined that these rate adjustments do not have significant “takings” implications. The rate adjustments do not deprive the public, state, or local governments of rights or property.
The Department has determined that these rate adjustments do not have significant Federalism effects because they pertain solely to Federal-tribal relations and will not interfere with the roles, rights, and responsibilities of states.
In accordance with Executive Order 12988, the Office of the Solicitor has determined that this rule does not unduly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of the Order.
These rate adjustments do not affect the collections of information which have been approved by the Office of Information and Regulatory Affairs, Office of Management and Budget, under the Paperwork Reduction Act of 1995. The OMB Control Number is 1076-0141 and expires August 31, 2009.
The Department has determined that these rate adjustments do not constitute a major Federal action significantly affecting the quality of the human environment and that no detailed statement is required under the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370(d)).
Bureau of Land Management, Interior.
Notice of Intent (NOI).
The Bureau of Land Management (BLM) Lander Field Office announces its intent to prepare an EIS for a proposed conventional natural gas field development near Lysite, Wyoming. The proposed development project is known as the Gun Barrel/Madden and Iron Horse (GMI) Natural Gas Development Project and is located in Fremont and Natrona Counties, Wyoming.
This NOI initiates the public scoping process for the EIS. The purpose of the public scoping process is to determine relevant issues that will influence the scope of the environmental analysis and EIS alternatives. To provide the public with an opportunity to review the proposed project and project information, the BLM will host a meeting in Lander and a meeting in Casper, Wyoming, within 30 days of the publication of this notice. The BLM will notify the public of these meetings and any other opportunities for the public to be involved in the environmental process for this proposal at least 15 days prior to the event. Meeting dates, locations, and times will be announced by news release to the media, individual mailings, and postings on the following BLM Web site:
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publically available at any time. While you can ask us in your comment to withhold your personal indentifying information from public review, we cannot guarantee that we will be able to do so. The minutes and list of attendees for each scoping meeting will be made available to the public and open for 30 days after the meeting to any participant who wished to clarify the views he or she expressed.
You may submit written comments by any of the following methods:
• Web site:
• E-mail: 3Pam_Olson@blm.gov
• Fax: 307-332-8444
• Mail: Lander Field Office, 1335 Main Street, Lander, WY 82520.
Bureau of Land Management, Pam Olson, GMI Project Leader, Lander Field Office, 1335 Main Street, Lander, Wyoming 82520 or call (307) 332-8400, or send an electronic message to:
Under Section 102(2)(C) of the National Environmental Policy Act (NEPA), the BLM Lander Field Office announces its intent to prepare an EIS on the potential impacts of a proposed natural gas field development, ancillary facilities, pipelines and roads. The project area is located in Fremont and Natrona Counties, Wyoming, and encompasses approximately 146,000 acres of land, the majority of which is public land administered by the BLM Lander Field Office. A small portion of the project area is administered by the BLM Casper Field Office.
In January 2008, oil and gas operators and proponents of the project, EnCana Oil & Gas (USA), Inc. (EnCana), Burlington Resources Oil and Gas Company LP (Burlington), and Noble Energy, Inc. (Noble) submitted a proposal to the BLM to develop approximately 1,470 wells near Lysite, Wyoming. The proposed project area consists of three units operated by three different companies: the Gun Barrel Federal Exploratory Unit (Encana), the Madden Deep Federal Exploratory Unit (Burlington), and the Iron Horse Federal Exploratory Unit (Noble).
The purpose of the proposal is to continue extracting and developing natural gas within these three units during a ten to fifteen year period. The proponents estimate that within the Gun Barrel Unit, an additional 750 natural gas wells may be drilled; within the
Infrastructure required to support gas production would include: Well pads; water wells; gathering, treating, processing and compression facilities; water injection and evaporation facilities; electric powerlines; roads; gas flow lines; and pipelines. Gas would be transported through pipelines to centralized compression and treatment facilities.
Produced water would be reinjected in some instances, and disposed of through the use of surface facilities in other instances. Major issues identified at this time include: potential impacts to air quality; disposal of produced waste water; and potential effects of development and production on surface resources including vegetation and wildlife habitat.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined not to review the presiding administrative law judge's (“ALJ”) initial determination (“ID”) (Order No. 30) in the above-referenced investigation granting complainant's motion to terminate the investigation based on withdrawal of the complaint.
Michelle Walters, Office of the General Counsel, U.S. International Trade Commission, 500 E Street, SW., Washington, DC 20436, telephone (202) 708-5468. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street, SW., Washington, DC 20436, telephone (202) 205-2000. General information concerning the Commission may also be obtained by accessing its Internet server at
On January 4, 2006, the Commission instituted this investigation, based on a complaint filed by InterVideo Technology Corporation of Taiwan (“InterVideo”), alleging violations of section 337 of the Tariff Act of 1930 (19 U.S.C. **1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain personal computer consumer electronic convergent devices, components thereof, and products containing the same by reason of infringement of claims 1-10 of United States Patent No. 6,765,788 (“the ‘788 patent”). Complainant Intervideo, through subsequent corporate mergers, now operates and is known as Corel (Taiwan) Corporation (“Corel”). The complaint named four respondents: Dell, Inc. of Texas, WinBook Computer Corporation of Ohio (“WinBook”), Cyberlink Corporation of Taiwan, and Cyberlink.com Corporation of California. WinBook has been terminated from the investigation on the basis of a settlement agreement.
On April 29, 2008, complainant Corel filed a motion to terminate the investigation based on withdrawal of the complaint in its entirety.
On May 12, 2008, the ALJ issued the subject ID, granting complainant's motion to terminate the investigation. No petitions for review were filed.
The Commission has determined not to review the ID.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in sections 210.21(a)(1) and 210.42 of the Commission's Rules of Practice and Procedure (19 CFR 210.21(a)(1) and 210.42).
By order of the Commission.
U.S. International Trade Commission.
Institution of investigation pursuant to 19 U.S.C. 1337.
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on May 2, 2008, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of Ford Global Technologies, LLC of Dearborn, Michigan. The complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain automotive parts that infringe on U.S. Design Patent Nos. D498,444; D501,162; D510,551; D508,223; D500,717; D539,448; D500,969; and D500,970. The complaint further alleges that an industry in the United States exists as required by subsection (a)(2) of section 337.
The complainant requests that the Commission institute an investigation and, after the investigation, issue exclusion orders and cease and desist orders.
The complaint, except for any confidential information contained therein, is available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street, SW., Room 112, Washington, DC 20436, telephone 202-205-2000. Hearing impaired individuals are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its Internet server at
Stephen R. Smith, Office of Unfair Import Investigations, U.S. International Trade Commission, telephone (202) 205-2746.
The authority for institution of this investigation is contained in section 337
(1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain automotive parts that infringe on U.S. Design Patent Nos. D498,444; D501,162; D510,551; D508,223; D500,717; D539,448; D500,969; or D500,970; and whether an industry in the United States exists as required by subsection (a)(2) of section 337;
(2) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served:
(a) The complainant is—
(b) The respondents are the following entities alleged to be in violation of section 337, and are the parties upon which the complaint is to be served:
(c) The Commission investigative attorney, party to this investigation, is Stephen R. Smith, Esq., Office of Unfair Import Investigations, U.S. International Trade Commission, 500 E Street, SW., Suite 401, Washington, DC 20436; and
(3) For the investigation so instituted, the Honorable Theodore Essex is designated as the presiding administrative law judge.
Responses to the complaint and the notice of investigation must be submitted by the named respondents in accordance with section 210.13 of the Commission's Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(d) and 210.13(a), such responses will be considered by the Commission if received not later than 20 days after the date of service by the Commission of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown.
Failure of a respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter an initial determination and a final determination containing such findings, and may result in the issuance of an exclusion order or a cease and desist order or both directed against the respondent.
By order of the Commission.
In accordance with 28 CFR 50.7 and Section 122 of the Comprehensive Environmental Response, Compensation and Liability Act (“CERCLA”), 42 U.S.C. 9622, the Department of Justice gives notice that a proposed Consent Decree, in
Under the proposed Consent Decree, the Settling Defendants are obligated to implement the remedy selected by the U.S. Environmental Protection Agency (“EPA”) in the Record of Decision (“ROD”) for the Site, and to pay $550,000 in partial recovery of the United States' past response costs incurred at the Site as well as EPA's future costs of overseeing the implementation of the remedial action.
The Department of Justice will receive, for a period of thirty (30) days from the date of this publication, comments relating to the proposed Consent Decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and either e-mailed to
The proposed Consent Decree may be examined at: (1) The Office of the United States Attorney for the Northern District of Illinois, Rockford Division, 308 West State Street, Suite 300, Rockford, Illinois 61101 (815) 987-4444); and (2) the United States Environmental Protection Agency (Region 5), 77 West Jackson Blvd., Chicago, IL 60604-3507 (contact: John C. Matson ((312) 886-2243).
During the public comment period, the proposed Consent Decree may also be examined on the following U.S. Department of Justice Web site,
Notice is hereby given that, on April 23, 2008, 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 Clean Diesel V intends to file additional written notifications disclosing all changes in membership.
On January 10, 2008, Clean Diesel V 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 February 27, 2008. A notice was published in the
Mine Safety and Health Administration, Labor.
Correction Notice.
This is a correction to a notice of petitions for modification of existing safety standards that was published in the
Marine Mammal Commission.
Notice.
Marine Mammal Protection Act of 1972 (1361
The U.S. Marine Mammal Commission is seeking proposals for research and related activities that will further the conservation and management goals of the Marine Mammal Protection Act. Proposals should be tailored to address either of two focused research topics: (1) Conservation of Critically Endangered Marine Mammal Species or Populations and (2) Indirect Effects of Fisheries on Marine Mammals.
Proposals must be received by 15 July 2008, 5 p.m., EDT.
Proposals should be submitted electronically in MSWord, WordPerfect, or Adobe PDF format to Ms. Mina Innes, Research Program Officer, at the Marine Mammal Commission, e-mail address:
Inquiries should be directed to Dr. Robert Gisiner, Scientific Program Director, by mail (4340 East-West Highway, Room 700, Bethesda, MD 20814), phone (301-504-0087), or e-mail
Grantees or contractors whose projects involve the taking of marine mammals will be expected to obtain all necessary permits and authorizations for their projects before engaging in such activities.
Information on the focused research topics, selection criteria, required formats for full proposals, the submission process, and the submission schedule is provided below.
The Commission is requesting proposals for research or other activities that will promote the conservation of critically endangered marine mammal species or populations, with a particular focus on those for which current research efforts are non-existent or underfunded. Such proposals could include the following:
• Collection and analysis of data on critically endangered marine mammals and/or the threats facing them, with the goal of informing conservation decisions;
• Development and implementation of strategies for prioritizing and commumcating critical conservation needs to the public and decision-makers;
• Initiation of conservation activities to address the principal threats facing critically endangered marine mammals.
The at-risk species or populations may occur in domestic, foreign, or international waters. The Commission is not likely to fund proposals to continue ongoing conservation programs but will consider proposals to provide seed money or start-up funds to initiate new efforts, with the goal of creating self-sustaining conservation efforts that do not duplicate pre-existing efforts. Priority will be given to proposals based on the degree of endangerment to the species or population, the usefulness and relevance of the research in addressing a threat and promoting conservation, and the extent to which other funding sources are or are not available. Proposals should reflect a thorough knowledge of ongoing research and conservation efforts and should clearly indicate both the importance of the proposed work and the limitations imposed by current funding levels or opportunities.
Commercial, recreational, and subsistence fisheries have the potential to affect marine mammals and other predators directly through bycatch and indirectly by altering the availability of prey resources (
The Commission is requesting proposals for studies that seek to describe quantitatively the indirect effects of fishing on marine mammals or to develop approaches for mitigating those effects. Proposals may include, but are not limited to, the following approaches:
• Comparative experiments between fished and unfished areas to assess the potential impact of fisheries on marine mammals;
• Development and performance testing of conceptual fishery management approaches that explicitly consider indirect effects of fishing on marine mammals;
• Ecosystem dynamics modeling studies that investigate the functional relationships between marine mammal predators, their prey, and fisheries in appropriate spatial/temporal context (
• Field validation of such modeling studies.
Methodological approaches and data requirements for such projects are described on pages 41-44 of Chapter 3, “Indirect Fisheries Interactions,” in J.E. Reynolds III
Proposals on other aspects of indirect fishery effects on marine mammals will be considered, but priority will be given to proposals that address critical gaps in current understanding of indirect fishery effects. In all cases, proposals should indicate a thorough knowledge of relevant topics and should describe explicitly how the proposed work will build upon, but not duplicate, previous efforts. The Commission will consider proposals for workshops or reviews of historical data as well as original research projects.
• Relevance to the focused research topic as described in this statement and to the overall mission of the Marine Mammal Commission as described on the Commission's Web site
• Scientific and conservation merit of the proposed approach and anticipated end products (30 points).
• Qualifications of the proposal team (15 points).
• Realism of the proposed budget (15 points).
Commission staff will compile reviewer recommendations and forward the ranked recommendations to the Commissioners for final review. The Commissioners will make the final funding determination based on their assessment of the combination of projects that will most effectively promote the conservation and management goals of the Marine Mammal Protection Act within the funds allocated for this funding opportunity.
The proposal body must not exceed eight pages (single-sided, or four pages double-sided) using 12 point font, exclusive of cover page, budget page(s), curriculum vitae, and supporting materials.
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15 July 2008; 5 p.m. EDT Full proposals due to the Marine Mammal Commission.
11 August 2008; 5 p.m. EDT Successful applicants informed of final Decisions.
Proposals received after the due date and time listed above will not, under any circumstances, be forwarded for review.
10 a.m., Wednesday, June 11, 2008
The Richard V. Backley Hearing Room, 9th Floor, 601 New Jersey Avenue, NW., Washington, DC.
Open.
The Commission will consider and act upon the following in open session:
Any person attending this meeting who requires special accessibility features and/or auxiliary aids, such as sign language interpreters, must inform the Commission in advance of those needs. Subject to 29 CFR 2706.150(a)(3) and 2706.160(d).
Jean Ellen, (202) 434-9950 / (202) 708-9300 for TDD Relay / 1-800-877-8339 for toll free.
9:30 a.m., Tuesday, June 10, 2008.
NTSB Conference Center, 429 L'Enfant Plaza, SW., Washington, DC 20594.
The three items are open to the public.
Telephone: (202) 314-6100.
Individuals requesting specific accommodations should contact Carol Bowling at (202) 314-6238 by Friday, June 6, 2008.
The public may view the meeting via a live or archived webcast by accessing a link under “News & Events” on the NTSB home page at
Vicky D'Onofrio, (202) 314-6410.
Nuclear Regulatory Commission (NRC).
The NRC staff has issued Regulatory Issue Summary (RIS) 2008-12; Considerations for Extended Interim Storage of Low-Level Radioactive Waste by Fuel Cycle and Materials Licensees. The RIS is intended to update and replace information provided in Information Notice 90-09, “Extended Interim Storage of Low-Level Radioactive Waste by Fuel Cycle and Materials Licensees,” February 5, 1990. The RIS is dated May 9, 2008.
Mr. James Shaffner, Project Manager, Low-Level Waste Branch, Environmental Protection and Performance Assessment Directorate, Division of Waste Management and Environmental Protection (DWMEP), U.S. Nuclear Regulatory Commission, Washington, DC 20555. Telephone (301) 415-5496; fax number (301) 415-5397; e-mail
In its annual report (SECY 06-193, “Annual Review of the Need for Rulemaking and/or Regulatory Guidance on Low-Level Radioactive Waste Storage,” September 6, 2006) to the Commission on the need for rulemaking or guidance related to extended interim storage of Low-Level Radioactive Waste (LLRW), the NRC staff reported its intention to review and revise, as necessary, guidance to NRC licensees faced with the prospect of mandatory extended interim storage of low-level radioactive waste. Staff stated that the emphasis of the effort would be directed toward the needs of fuel cycle and radioactive materials licenses that may be required to store waste classified as Class B or C waste, in accordance with 10 CFR part 61, “Licensing Land Disposal of Radioactive Waste,” after June 30, 2008, because of the limitation of access to the Barnwell Low-Level Radioactive Waste Disposal Facility. In its follow-up report on the topic, SECY 07-083, dated October 22, 2007, staff outlined the process and timeline for accomplishment of the guidance update. The emphasis on fuel cycle and radioactive materials licensees was based on the understanding that 10 CFR part 50 licensees (production and utilization facilities) were more likely to have pre-existing technical, physical, and financial infrastructure to adequately manage any required extended interim storage of LLRW.
The limitation of disposal access at the Barnwell disposal facility to States that comprise the Atlantic LLRW Compact (South Carolina, Connecticut, and New Jersey) as of July 1, 2008 is likely to require many radioactive materials licensees outside of that compact that generate Class B and C LLRW to store such waste. In anticipation of this circumstance, NRC staff reviewed and updated information related to extended interim storage of LLRW by fuel cycle and radioactive materials licensees. In SECY-07-083, staff determined that the most efficient and transparent means to accomplish this was to revise IN 90-09. However, in consultation with other NRC offices it was later determined that the most appropriate form of generic communication for imparting the information was a RIS. Although the RIS does not impose any additional regulatory requirements on NRC licensees, staff considered that it also may be of some interest to Agreement State radiation control programs and their licensees.
NRC staff considered the need for the revision of IN 90-09 based on changes in regulatory circumstances that have occurred since 1990. These include, but are not limited to, the changing nature of and access to permanent disposal capacity, emerging technologies related to the processing, treatment and handling of radioactive waste, and changed security considerations based on the circumstances of September 11, 2001.
The updated information in the form of RIS 2008-12 is responsive to both licensees who will be able to store LLRW in accordance with terms and conditions of existing licenses as well as those whose circumstances may have changed such that a license amendment is required. The RIS includes a number of major considerations related to extended interim storage. These include reaffirmations of two considerations, related to storage time limit and suitable waste forms for storage, formerly addressed but never finalized by NRC staff in SECY 94-198, “Review of Existing Guidance Concerning Extended Storage of Low-Level Radioactive Waste” (August 1, 1994).
The RIS includes four enclosures to inform its contents and facilitate its use. The enclosures include licensing considerations, updated State and compact contacts, additional references, and recently issued generic communications.
RIS 2008-12 provides updated information related to extended interim storage of LLRW by fuel cycle and materials licensees. It imposes no additional regulatory requirements. The RIS is intended to replace the IN 90-09 dated February 5, 1990. Further, any references to IN 90-09 contained in other NRC guidance or technical
The RIS was developed in accordance with the requirements of NRC Inspection Manual Chapter 0730, “Generic Communications Regarding Materials and Fuel Cycle Issues.” In the process of preparing RIS 2008-12, FSME staff consulted with other NRC Headquarters offices, NRC regional offices, State officials in both Agreement States and non-Agreement States and territories, the Organization of Agreement States, the Conference of Radiation Control Program Directors and several licensees licensed by either NRC or Agreement State Radiation Control Programs.
Documents related to this action are available electronically in the NRC's Reading Room at
For the Nuclear Regulatory Commission.
The U.S. Nuclear Regulatory Commission (the Commission) is considering the issuance of an order under 10 CFR 50.80 and 10 CFR 72.50 approving the direct transfer of Facility Operating Licenses, which are numbered DPR-42 and DPR-60 for the Prairie Island Nuclear Generating Plant (PINGP), Units 1 and 2 and Material License No. SNM-2506 (the licenses) for the PINGP Independent Spent Fuel Storage Installation (ISFSI), to the extent currently held by Nuclear Management Company, LLC (NMC) as operator of PINGP Units 1 and 2, and PINGP ISFSI. The transfer would be to Northern States Power Company (NSPM), an Xcel Energy company, and current licensed owner of PINGP, Units 1 and 2 and PINGP ISFSI. The Commission is also considering amending the license for administrative purposes to reflect the proposed transfer.
According to an application for approval dated April 16, 2008, filed by NMC, NSPM would acquire operating authority of the facilities following approval of the proposed license transfer, and would be responsible for the operation and maintenance of PINGP Units 1 and 2, and PINGP ISFSI. NMC would be integrated into the current NSPM organization which would combine the ownership and operating authority into a single organization.
No physical changes to the PINGP Units 1 and 2, or PINGP ISFSI facility or operational changes are being proposed in the application.
The proposed amendment would delete references to NMC, and authorize NSPM to operate PINGP and the PINGP ISFSI, and to receive, possess, or use related licensed materials under the applicable conditions and authorizations included in the licenses. This request to transfer operating authority and the conforming license amendments involve no change in plant ownership.
Pursuant to 10 CFR 50.80 and 10 CFR 72.50, no license, or any right thereunder, shall be transferred, directly or indirectly, through transfer of control of the license, unless the Commission shall give its consent in writing. The Commission will approve an application for the direct transfer of a license, if the Commission determines that the proposed transferee is qualified to hold the license, and that the transfer is otherwise consistent with applicable provisions of law, regulations, and orders issued by the Commission pursuant thereto.
Before issuance of the proposed conforming license amendment, the Commission will have made findings required by the Atomic Energy Act of 1954, as amended (the Act), and the Commission's regulations.
As provided in 10 CFR 2.1315, unless otherwise determined by the Commission with regard to a specific application, the Commission has determined that any amendment to the license of a utilization facility, or to the license of an ISFSI, which does no more than conform the license to reflect the transfer action involves no significant hazards consideration, and no genuine issue as to whether the health and safety of the public will be significantly affected. No contrary determination has been made with respect to this specific license amendment application. In light of the generic determination reflected in 10 CFR 2.1315, no public comments with respect to significant hazards considerations are being solicited, notwithstanding the general comment procedures contained in 10 CFR 50.91.
The filing of requests for hearing and petitions for leave to intervene, and written comments with regard to the license transfer application, are discussed below.
Within 20 days from the date of publication of this notice, any person(s) whose interest may be affected by the Commission's action on the application may request a hearing and intervention via electronic submission through the NRC E-filing system. Requests for a hearing and petitions for leave to intervene should be filed in accordance with the Commission's rules of practice set forth in Subpart C “Rules of General Applicability: Hearing Requests, Petitions to Intervene, Availability of Documents, Selection of Specific Hearing Procedures, Presiding Officer Powers, and General Hearing Management for NRC Adjudicatory Hearings,” of 10 CFR Part 2. In particular, such requests and petitions must comply with the requirements set forth in 10 CFR 2.309. Untimely requests and petitions may be denied, as provided in 10 CFR 2.309(c)(1), unless good cause for failure to file on time is established. In addition, an untimely
A request for hearing or a petition for leave to intervene must be filed in accordance with the NRC E-Filing rule, which the NRC promulgated on August 28, 2007 (72 FR 49139). The E-Filing process requires participants to submit and serve documents over the internet or in some cases to mail copies on electronic storage media. Participants may not submit paper copies of their filings unless they seek a waiver in accordance with the procedures described below.
To comply with the procedural requirements of E-Filing, at least ten (10) days prior to the filing deadline, the petitioner/requestor must contact the Office of the Secretary by e-mail at
Once a petitioner/requestor has obtained a digital ID certificate, had a docket created, and downloaded the EIE viewer, it can then submit a request for hearing or petition for leave to intervene. Submissions should be in Portable Document Format (PDF) in accordance with NRC guidance available on the NRC public Web site at
A person filing electronically may seek assistance through the “Contact Us” link located on the NRC Web site at
Participants who believe that they have a good cause for not submitting documents electronically must file a motion, in accordance with 10 CFR 2.302(g), with their initial paper filing requesting authorization to continue to submit documents in paper format. Such filings must be submitted by: (1) First class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemaking and Adjudications Staff; or (2) courier, express mail, or expedited delivery service to the Office of the Secretary, Sixteenth Floor, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852, Attention: Rulemaking and Adjudications Staff. Participants filing a document in this manner are responsible for serving the document on all other participants. Filing is considered complete by first-class mail as of the time of deposit in the mail, or by courier, express mail, or expedited delivery service upon depositing the document with the provider of the service.
Non-timely requests and/or petitions and contentions will not be entertained absent a determination by the Commission, the presiding officer, or the Atomic Safety and Licensing Board that the petition and/or request should be granted and/or the contentions should be admitted, based on a balancing of the factors specified in 10 CFR 2.309(c)(1)(i)-(viii). To be timely, filings must be submitted no later than 11:59 p.m. Eastern Time on the due date. Documents submitted in adjudicatory proceedings will appear in NRC's electronic hearing docket which is available to the public at
The Commission will issue a notice or order granting or denying a hearing request or intervention petition, designating the issues for any hearing that will be held and designating the Presiding Officer. A notice granting a hearing will be published in the
Within 30 days from the date of publication of this notice, persons may submit written comments regarding the license transfer application, as provided for in 10 CFR 2.1305. The Commission will consider and, if appropriate, respond to these comments, but such comments will not otherwise constitute part of the decisional record. Comments should be submitted to the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemakings and Adjudications Staff, and should cite the publication date and page number of this
For further details with respect to this license transfer application, see the application dated April 16, 2008, available for public inspection at the Commission's Public Document Room (PDR), located at One White Flint North, Public File Area O1 F21, 11555 Rockville Pike (first floor), Rockville, Maryland. Publicly available records will be accessible electronically from the Agency wide Documents Access and Management System's (ADAMS) Public Electronic Reading Room on the Internet at the NRC Web site,
For the Nuclear Regulatory Commission.
The U.S. Nuclear Regulatory Commission (the Commission) is considering the issuance of an order under 10 CFR 50.80 approving the direct transfer of the Renewed Facility Operating License No. DPR-22 (the license) for the Monticello Nuclear Generating Plant (MNGP) to the extent currently held by Nuclear Management Company, LLC (NMC), as operator of MNGP. The transfer would be to Northern States Power Company (NSPM), an Xcel Energy company, and current licensed owner of MNGP. The Commission is also considering amending the license for administrative purposes to reflect the proposed transfer.
According to an application for approval dated April 16, 2008, filed by NMC, NSPM would acquire operating authority of the facility following approval of the proposed license transfer, and would be responsible for the operation and maintenance of MNGP. NMC will be integrated into the current NSPM organization which would combine the ownership and operating authority into a single organization.
No physical changes to the MNGP facility or operational changes are being proposed in the application.
The proposed amendment would delete references to NMC, and to authorize NSPM to operate MNGP, and to receive, possess, or use related licensed materials under the applicable conditions and authorizations included in the license. This request to transfer operating authority and the conforming license amendment involve no change in plant ownership.
Pursuant to 10 CFR 50.80, no license, or any right thereunder, shall be transferred, directly or indirectly, through transfer of control of the license, unless the Commission shall give its consent in writing. The Commission will approve an application for the direct transfer of a license, if the Commission determines that the proposed transferee is qualified to hold the license, and that the transfer is otherwise consistent with applicable provisions of law, regulations, and orders issued by the Commission pursuant thereto.
Before issuance of the proposed conforming license amendment, the Commission will have made findings required by the Atomic Energy Act of 1954, as amended (the Act), and the Commission's regulations.
As provided in 10 CFR 2.1315, unless otherwise determined by the Commission with regard to a specific application, the Commission has determined that any amendment to the license of a utilization facility, which does no more than conform the license to reflect the transfer action involves no significant hazards consideration. No contrary determination has been made with respect to this specific license amendment application. In light of the generic determination reflected in 10 CFR 2.1315, no public comments with respect to significant hazards considerations are being solicited, notwithstanding the general comment procedures contained in 10 CFR 50.91.
The filing of requests for hearing and petitions for leave to intervene, and written comments with regard to the license transfer application, are discussed below.
Within 20 days from the date of publication of this notice, any person(s) whose interest may be affected by the Commission's action on the application may request a hearing and intervention via electronic submission through the NRC E-filing system. Requests for a hearing and petitions for leave to intervene should be filed in accordance with the Commission's rules of practice set forth in Subpart C “Rules of General Applicability: Hearing Requests, Petitions to Intervene, Availability of Documents, Selection of Specific Hearing Procedures, Presiding Officer Powers, and General Hearing Management for NRC Adjudicatory Hearings,” of 10 CFR Part 2. In particular, such requests and petitions must comply with the requirements set forth in 10 CFR 2.309. Untimely requests and petitions may be denied, as provided in 10 CFR 2.309(c)(1), unless good cause for failure to file on time is established. In addition, an untimely request or petition should address the factors that the Commission will also consider, in reviewing untimely requests or petitions, set forth in 10 CFR 2.309(c)(1)(i)-(viii).
A request for hearing or a petition for leave to intervene must be filed in accordance with the NRC E-Filing rule, which the NRC promulgated on August 28, 2007 (72 FR 49139). The E-Filing process requires participants to submit and serve documents over the internet or in some cases to mail copies on electronic storage media. Participants may not submit paper copies of their filings unless they seek a waiver in accordance with the procedures described below.
To comply with the procedural requirements of E-Filing, at least ten (10) days prior to the filing deadline, the petitioner/ requestor must contact the Office of the Secretary by e-mail at
Once a petitioner/requestor has obtained a digital ID certificate, had a docket created, and downloaded the EIE viewer, it can then submit a request for hearing or petition for leave to intervene. Submissions should be in Portable Document Format (PDF) in accordance with NRC guidance available on the NRC public website at
A person filing electronically may seek assistance through the “Contact Us” link located on the NRC Web site at
Participants who believe that they have a good cause for not submitting documents electronically must file a motion, in accordance with 10 CFR 2.302(g), with their initial paper filing requesting authorization to continue to submit documents in paper format. Such filings must be submitted by: (1) First class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemaking and Adjudications Staff; or (2) courier, express mail, or expedited delivery service to the Office of the Secretary, Sixteenth Floor, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852, Attention: Rulemaking and Adjudications Staff. Participants filing a document in this manner are responsible for serving the document on all other participants. Filing is considered complete by first-class mail as of the time of deposit in the mail, or by courier, express mail, or expedited delivery service upon depositing the document with the provider of the service.
Non-timely requests and/or petitions and contentions will not be entertained absent a determination by the Commission, the presiding officer, or the Atomic Safety and Licensing Board that the petition and/or request should be granted and/or the contentions should be admitted, based on a balancing of the factors specified in 10 CFR 2.309(c)(1)(i)-(viii). To be timely, filings must be submitted no later than 11:59 p.m. Eastern Time on the due date.
Documents submitted in adjudicatory proceedings will appear in NRC's electronic hearing docket which is available to the public at
The Commission will issue a notice or order granting or denying a hearing request or intervention petition, designating the issues for any hearing that will be held and designating the Presiding Officer. A notice granting a hearing will be published in the
Within 30 days from the date of publication of this notice, persons may submit written comments regarding the license transfer application, as provided for in 10 CFR 2.1305. The Commission will consider and, if appropriate, respond to these comments, but such comments will not otherwise constitute part of the decisional record. Comments should be submitted to the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemakings and Adjudications Staff, and should cite the publication date and page number of this
For further details with respect to this license transfer application, see the application dated April 16, 2008, available for public inspection at the Commission's Public Document Room (PDR), located at One White Flint North, Public File Area O1 F21, 11555 Rockville Pike (first floor), Rockville, Maryland. Publicly available records will be accessible electronically from the Agency wide Documents Access and Management System's (ADAMS) Public Electronic Reading Room on the Internet at the NRC Web site,
For the Nuclear Regulatory Commission.
The ACRS Subcommittee on ESBWR will hold a meeting on June 18-19, 2008, Room T2 B3, 11545 Rockville Pike, Rockville, Maryland.
The entire meeting will be open to public attendance, with the exception of a portion that may be closed to protect information that is proprietary to General Electric-Hitachi (GEH) Nuclear Energy and its contractors pursuant to 5 U.S.C. 552b(c)(4).
The agenda for the subject meeting shall be as follows:
Wednesday June 18, 2008—8:30 a.m., until 5 p.m.
Thursday June 19, 2008—8:30 a.m., until 5 p.m.
The Subcommittee will review several chapters of the Safety Evaluation Report with Open Items associated with the Economic Simplified Boiling Water Reactor (ESBWR) Design Certification Application. The Subcommittee will hear presentations by and hold discussions with representatives of the NRC staff, GEH, and other interested persons regarding this matter. The Subcommittee will gather information, analyze relevant issues and facts, and formulate proposed positions and actions, as appropriate, for deliberation by the full Committee.
Members of the public desiring to provide oral statements and/or written comments should notify the Designated Federal Official, Dr. Harold VanderMolen (telephone 301-415-6236) five days prior to the meeting, if possible, so that appropriate arrangements can be made. Electronic recordings will be permitted only during those portions of the meeting that are open to the public. Detailed procedures for the conduct of and participation in ACRS meetings were published in the
Further information regarding this meeting can be obtained by contacting the Designated Federal Official between
Executive Office of the President, Office of Management and Budget.
Notice of availability of the 2008 Circular A-133 Compliance Supplement.
This notice announces the availability of the 2008 Circular A-133 Compliance Supplement. The notice also offered interested parties an opportunity to comment on the 2008 Circular A-133 Compliance Supplement. The 2008 Supplement adds seven programs, including three programs added to an existing cluster. It has also been updated for program changes and technical corrections. In total, the 2008 Compliance Supplement includes 178 individual programs. A list of changes to the 2008 Supplement can be found at Appendix V. Due to its length, the 2008 Supplement is not included in this Notice. See
The 2008 Supplement will apply to audits of fiscal years beginning after June 30, 2007 and supersedes the 2007 Supplement. All comments on the 2008 Supplement must be in writing and received by October 31, 2008. Late comments will be considered to the extent practicable.
Due to potential delays in OMB's receipt and processing of mail sent through the U.S. Postal Service, we encourage respondents to submit comments electronically to ensure timely receipt. We cannot guarantee that comments mailed will be received before the comment closing date.
Electronic mail comments may be submitted to:
Comments may be mailed to Gilbert Tran, Office of Federal Financial Management, Office of Management and Budget, 725 17th Street, NW., Room 6025, New Executive Office Building, Washington, DC 20503.
Comments may also be sent via
Copies of the 2008 Supplement may be purchased at any Government Printing Office (GPO) bookstore (stock number: 041-001-00658-3). The main GPO bookstore is located at 710 North Capitol Street, NW., Washington, DC 20401, (202) 512-0132. A copy may also be obtained under the Grants Management heading from the OMB home page on the Internet at
Recipients should contact their cognizant or oversight agency for audit, or Federal awarding agency, as appropriate under the circumstances. Subrecipients should contact their pass-through entity. Federal agencies should contact Gilbert Tran, Office of Management and Budget, Office of Federal Financial Management, at (202) 395-3052.
The following is a notice of applications for deregistration under section 8(f) of the Investment Company Act of 1940 for the month of May 2008. A copy of each application may be obtained for a fee at the SEC's Public Reference Branch (tel. 202-551-5850). An order granting each application will be issued unless the SEC orders a hearing. Interested persons may request a hearing on any application by writing to the SEC's Secretary at the address below and serving the relevant applicant with a copy of the request, personally or by mail. Hearing requests should be received by the SEC by 5:30 p.m. on June 24, 2008, and should be accompanied by proof of service on the applicant, in the form of an affidavit or, for lawyers, a certificate of service. Hearing requests should state the nature of the writer's interest, the reason for the request, and the issues contested. Persons who wish to be notified of a hearing may request notification by writing to the Secretary, U.S. Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.
Diane L. Titus at (202) 551-6810, SEC, Division of Investment Management, Office of Investment Company Regulation, 100 F Street, NE., Washington, DC 20549-4041.
On January 25, 2005, the Chicago Board Options Exchange, Incorporated (“CBOE”) filed with the Securities and Exchange Commission (“Commission” or “SEC”) a proposed rule change pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
In addition, four other exchanges submitted proposals to list and trade Gold Trust Options. Specifically, the International Securities Exchange, LLC (“ISE”) submitted its proposal on February 7, 2008, the American Stock Exchange LLC (“Amex”) filed on February 20, 2008, the Philadelphia Stock Exchange, Inc. (“Phlx”) filed on February 28, 2008, and NYSE Arca, Inc. (“NYSE Arca”) filed on May 21, 2008 with the Commission the proposed rule changes as described in Items I and II below, which items have been prepared substantially by the Amex, ISE, NYSE Arca, and Phlx. On May 20, 2008, ISE and Phlx submitted Amendment No. 1 to their respective proposals. On May 21, 2008, ISE and Phlx submitted Amendment No. 2 to their respective proposals and Amex submitted Amendment No. 1 to its proposal. The proposals submitted by the Amex, ISE, NYSE Arca, and Phlx are substantively identical to CBOE's proposal. Pursuant to Section 19(b)(1) of the Act
Amex, ISE, NYSE Arca, and Phlx each propose to amend certain of their respective rules to enable the listing and trading of Gold Trust Options on their markets. The text of the proposals is available at each of the respective exchanges, the Commission's Public Reference Room, and
In their filings with the Commission, the Amex, ISE, NYSE Arca, and Phlx included statements concerning the purpose of, and basis for, the proposed rule change. The text of these statements may be examined at the places specified in Item III below. These exchanges have prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.
Amex, ISE, NYSE Arca, and Phlx each state that the purpose of its proposed rule changes is to permit the listing and trading of Gold Trust Options.
Currently, the rules of these exchanges permit only certain “Units” (also referred to herein as exchange traded funds (“ETFs”)) to underlie options traded on their markets.
Apart from allowing the SPDR Gold Trust to be an underlying for options traded on Amex, ISE, NYSE Arca, and Phlx as described above, the listing standards for ETFs would remain unchanged from those that apply under the current rules of these exchanges. ETFs on which options may be listed and traded would still have to be listed and traded on a national securities exchange and satisfy the other listing standards set forth in the respective rules of each of these exchanges.
Specifically, in addition to satisfying the aforementioned listing requirements, Units would have to continue to: (1) Meet the criteria and guidelines under the exchanges' rules for underlying ETFs; or (2) be available for creation or redemption each business day from or through the issuer in cash or in kind at a price related to net asset value, and the issuer must be obligated to issue Units in a specified aggregate number even if some or all of the investment assets required to be deposited have not been received by the issuer, subject to the condition that the person obligated to deposit the investments has undertaken to deliver the investment assets as soon as possible and such undertaking is secured by the delivery and maintenance of collateral consisting of cash or cash equivalents satisfactory to the issuer, as provided in the respective prospectus.
Amex, ISE, NYSE Arca, and Phlx each propose that the current continued listing standards for options on ETFs would apply to Gold Trust Options. Specifically, options on Units may be subject to the suspension of opening transactions as follows: (1) Following the initial twelve-month period beginning upon the commencement of trading of the Units, there are fewer than 50 record and/or beneficial holders of the Units for 30 or more consecutive trading days; (2) the value of the index or portfolio of securities, non-U.S. currency, or portfolio of commodities including commodity futures contracts, options on commodity futures contracts, swaps, forward contracts and/or options on physical commodities and/or Financial Instruments and Money Market Instruments on which Units are based is no longer calculated or available; or (3) such other event occurs or condition exists that in the opinion of the exchanges makes further dealing on the exchange inadvisable.
In addition, shares of the SPDR Gold Trust would not be deemed to meet the requirements for continued approval, and the Amex, ISE, NYSE Arca, and Phlx would not open for trading any additional series of option contracts of the class covering shares of the SPDR Gold Trust, if the shares of the SPDR Gold Trust cease to be an “NMS stock” as provided for in rules of these exchanges
Amex, ISE, NYSE Arca, and Phlx each represented that the addition of the SPDR Gold Trust to types of Units that may underlie listed options traded on the exchange would not have any effect on the rules pertaining to position and exercise limits
Amex, ISE, NYSE Arca, and Phlx also represent that the respective surveillance procedures applicable to Gold Trust Options would be similar to those applicable to all other options on ETFs currently traded on these exchanges. In addition, the Amex, ISE, NYSE Arca, and Phlx note that they may obtain information from the New York Mercantile Exchange, Inc. (“NYMEX”) through the Intermarket Surveillance Group (“ISG”) related to any financial instrument traded there that is based, in whole or in part, upon an interest in, or performance of, gold.
Amex, ISE, NYSE Arca, and Phlx each state that amending its rules to accommodate the listing and trading of Gold Trust Options will benefit investors by providing them with valuable risk management tools. Accordingly, these exchanges believe that the proposed rule changes are consistent with the requirements of Section 6(b) of the Act
Amex, ISE, NYSE Arca, and Phlx each believe that the proposed rule changes will not impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
Amex, ISE, NYSE Arca, and Phlx each state that no written comments were solicited or received with respect to the proposed rule changes.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule changes are 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 Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.
All submissions should refer to File Numbers SR-Amex-2008-15; SR-ISE-2008-12; SR-NYSEArca-2008-52; and SR-Phlx-2008-17. 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 (
After careful consideration, the Commission finds that the proposed rule changes are consistent with the requirements of the Act and the rules and regulations thereunder applicable to a national securities exchange
As national securities exchanges, each of Amex, CBOE, ISE, NYSE Arca, and Phlx is required under Section 6(b)(1) of the Act
Gold Trust Options will trade as options under the trading rules of each of the exchanges. These rules, among other things, are designed to avoid trading through better displayed prices for Gold Trust Options available on other exchanges and, thereby, satisfy each exchange's obligation under the Options Intermarket Linkage Plan.
The Amex, CBOE, ISE, NYSE Arca, and Phlx have all represented that they have surveillance programs in place for the listing and trading of options based on the SPDR Gold Trust. For example, these exchanges may obtain trading information via the ISG from the NYMEX related to any financial instrument traded there that is based, in whole or in part, upon an interest in, or performance of, gold. Additionally, the listing and trading of Gold Trust Options will be subject to the exchanges' rules pertaining to position and exercise limits
In addition, the Commission finds good cause, pursuant to Section 19(b)(2) of the Act,
By the Commission.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
BSE proposes to amend the Fee Schedule of the Boston Options Exchange facility (“BOX”) to modify the fees and credits associated with the Liquidity Make or Take Pricing Structure. While changes to the Fee Schedule pursuant to this proposal are effective upon filing, the Exchange designated the changes operative for June 2, 2008. The text of the proposed rule change is available at BSE, the Commission's Public Reference Room, and
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 proposes to amend Section 7 of the BOX Fee Schedule
Tier 2 Classes are among the most liquid and most actively traded options on BOX. Due to the vast liquidity in the Tier 2 Classes, BOX's cost to trade these classes is less than the costs of other classes traded on BOX. The Exchange believes that such lower costs should therefore result in decreased fees for trading in these Tier 2 Classes.
Furthermore, BOX proposes to distribute a complete list of the classes included in Tier 1 and Tier 2 pricing to participants via Regulatory Circular. The Exchange believes that distributing a Regulatory Circular containing the Tier 1 and Tier 2 Classes is the best method of notifying and informing Participants of the relevant pricing structure.
The Exchange believes that the proposal is consistent with the requirements of Section 6(b) of the Act,
The Exchange does not believe that the proposed rule change will impose any burden on competition that is 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.
The foregoing proposed rule change is effective upon filing pursuant to Section 19(b)(3)(A)(ii)
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.
• Use the Commission's Internet comment form (
• Send an e-mail to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.
All submissions should refer to File Number SR-BSE-2008-31. 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 Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange proposes to amend CBOE Rule 17.50, “Imposition of Fines for Minor Rule Violations,” to revise the provisions of CBOE Rule 17.50(g)(1) “Violations of Position Limits Rules.” The text of the proposed rule change is available on the Exchange's Web site (
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 proposes to increase and strengthen the sanctions imposed pursuant to its Minor Rule Violation Plan (“MRVP”) in connection with any member or customer who exceeds the Exchange's position limit in accordance with CBOE Rule 4.11. The Exchange believes that increasing the fine levels specified; consolidating individual members, member organizations, and customers into one category; and lengthening the surveillance period from a 12-month period to a rolling 24-month period will serve as an effective deterrent to such violative conduct.
In addition, the Exchange, as a member of the Intermarket Surveillance Group (“ISG”), as well as certain other self-regulatory organizations (“SROs”) on October 29, 2007 executed and filed with the Commission a final version of an Agreement pursuant to Section 17(d) of the Act (the “17d-2 Agreement”).
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
CBOE does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
No written comments were solicited or received on the proposed rule change.
Within 35 days of the date of publication of this notice in the
(A) By order approve such 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 Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On March 7, 2008, The Options Clearing Corporation (“OCC”) filed with the Securities and Exchange Commission (“Commission”) proposed rule change SR-OCC-2008-07 pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”).
The rule change helps to clarify the manner in which options and security futures on SPDR Gold Shares will be treated and cleared by adding an interpretation to the definition of “fund share” in Article I, Section 1 of OCC's By-Laws.
In its capacity as a “derivatives clearing organization” registered with the Commodity Futures Trading Commission (“CFTC”), OCC also filed the proposed rule change with the CFTC for prior approval by the CFTC pursuant to provisions of the Commodity Exchange Act (“CEA”).
Section 17A(b)(3)(F) of the Act requires, among other things, that the rules of a clearing agency be designed to promote the prompt and accurate clearance and settlement of securities transactions.
On the basis of the foregoing, the Commission finds that the proposed rule change is consistent with the requirements of the Act and in particular Section 17A of the Act and the rules and regulations thereunder.
By the Commission.
U.S. Small Business Administration.
Amendment 1.
This is an amendment of the Presidential declaration of a major disaster for the State of Arkansas (FEMA-1758-DR), dated 05/20/2008.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street, SW., Suite 6050, Washington, DC 20416.
The notice of the Presidential disaster declaration for the State of Arkansas, dated 05/20/2008 is hereby amended to include the following areas as adversely affected by the disaster:
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Amendment 8.
This is an amendment of the Presidential declaration of a major disaster for the State of Arkansas ( FEMA-1751-DR ) , dated 03/28/2008.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street, SW., Suite 6050, Washington, DC 20416.
The notice of the Presidential disaster declaration for the State of Arkansas, dated 03/28/2008 is hereby amended to include the following areas as adversely affected by the disaster:
All other counties contiguous to the above named primary county have previously been declared.
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Notice.
This is a notice of an Administrative declaration of a disaster for the State of Florida dated 05/30/2008.
Submit completed loan applications to: U.S. Small Business Administration, Processing And Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street, SW., Suite 6050, Washington, DC 20416.
Notice is hereby given that as a result of the Administrator's disaster declaration, applications for disaster loans may be filed at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 11269 5 and for economic injury is 11270 0.
The States which received an EIDL Declaration # are Florida.
U.S. Small Business Administration.
Amendment 2.
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Maine (FEMA-1755-DR), dated 05/14/2008.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street, Suite 6050, Washington, DC 20416.
The notice of the President's major disaster declaration for Private Non-Profit organizations in the State of Maine, dated 5/14/2008, is hereby amended to include the following areas as adversely affected by the disaster.
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Amendment 1.
This is an amendment of the Presidential declaration of a major disaster for the State of Mississippi (FEMA-1753-DR) , dated 05/08/2008.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street, SW., Suite 6050, Washington, DC 20416
The notice of the President's major disaster declaration for the State of Mississippi, dated 05/08/2008 is hereby amended to establish the incident period for this disaster as beginning 03/20/2008 and continuing through 05/19/2008.
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for the State of Mississippi (FEMA-1764-DR), dated 05/28/2008.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street, SW., Suite 6050, Washington, DC 20416.
Notice is hereby given that as a result of the President's major disaster declaration on 05/28/2008, applications for disaster loans may be filed at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 11266C and for economic injury is 112670.
U.S. Small Business Administration.
Amendment 3.
This is an amendment of the Presidential declaration of a major disaster for the State of Missouri (FEMA-1749-DR), dated 03/27/2008.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street, SW., Suite 6050, Washington, DC 20416
The notice of the President's major disaster declaration for the State of Missouri, dated 03/27/2008 is hereby amended to extend the deadline for filing applications for physical damages as a result of this disaster to 06/26/2008.
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Amendment 1.
This is an amendment of the Presidential declaration of a major disaster for the State of Oklahoma (FEMA-1756-DR), dated 05/14/2008.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street, SW., Suite 6050, Washington, DC 20416.
The notice of the President's major disaster declaration for the State of Oklahoma, dated 05/14/2008 is hereby amended to establish the incident period for this disaster as beginning 05/10/2008 and continuing through 05/13/2008.
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Amendment 2.
This is an amendment of the Presidential declaration of a major disaster for the State of Oklahoma (FEMA-1756-DR), dated 05/14/2008.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street, SW., Suite 6050, Washington, DC 20416.
The notice of the Presidential disaster declaration for the State of Oklahoma, dated 05/14/2008 is hereby amended to include the following areas as adversely affected by the disaster:
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of South Dakota (FEMA-1759-DR), dated 05/22/2008.
Submit completed loan applications to : U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street, SW., Suite 6050, Washington, DC 20416.
Notice is hereby given that as a result of the President's major disaster declaration on 05/22/2008, Private Non-Profit organizations that provide essential services of a governmental nature may file disaster loan applications at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 11268.
Federal Highway Administration (FHWA), USDOT.
Notice of Intent to prepare an Environmental Impact Statement (EIS).
The Federal Highway Administration is issuing this notice to advise the public and Indian Tribes that an Environmental Impact Statement (EIS) will be prepared for the proposed SR 502 Corridor Widening Project in Clark County, Washington.
Written comments on the purpose and need, scope of alternatives, and impacts to be considered in the EIS must be received no later than June 10, 2008, and must be sent to the Washington State Department of Transportation (WSDOT) at the address indicated below.
Oral and written comments may be given at the public meeting. This and all other public meetings will be accessible to persons with disabilities who may also request this information be prepared and supplied in alternate formats by calling Chris Tams at (360) 759-1310 or 1(866) 279-0730 at least 48-hours in advance of the meeting for WSDOT to make the necessary arrangements. Persons who are deaf or hard of hearing may access Washington State Telecommunications Relay Service by dialing 7-1-1 and asking to be connected to (360) 759-1310.
Comments or questions concerning this proposal will be accepted at the public meeting or can be sent to Chris Tams, Area Engineer, Washington State Department of Transportation Southwest Region, P.O. Box 1709, Vancouver, WA 98668-1709; by Fax at (360) 905-2062; or by e-mail to
Dean Moberg, Federal Highway Administration, 711 S. Capitol Way, Suite 501, Olympia, WA 98501, Telephone: (360) 534-9344 (direct) or (360) 753-9480 (general). Additional information on the SR 502 Corridor Widening Project can be found on the project Web site at:
The FHWA and WSDOT will prepare an EIS on the proposed widening of the SR 502 Corridor (NE 219th Street) in north Clark County from a two-lane roadway to a four-lane roadway with a median barrier separating westbound and eastbound travel. The SR 502 Corridor Widening is proposed between NE 15th Avenue and NE 102nd Avenue, for a length of approximately 5 miles. The project also proposes to construct paved shoulders for pedestrian and bicycle use, stormwater facilities, and three new signalized intersections on SR 502 at NE 29th Avenue, NE 50th Avenue, and NE 92 Avenue in addition to the existing signalized intersection on SR 502 at NE 72nd Avenue (Dollars Corner). These improvements are proposed to address the current and future deficiencies related to mobility and safety on the SR 502 corridor.
The SR 502 Corridor Widening Project began as an Environmental Assessment (EA) in early 2007. One agency scoping meeting and one public scoping meeting were held on February 22, 2007, to identify issues and concerns as well as provide input into establishing a range of alternatives for the project. A wide range of alternatives were considered between February and September 2007. Six “on-corridor” alternatives, including widening the existing facility directly to either the north or south of the existing facility, or equally on both sides from the centerline, were studied. Additionally, two “off-corridor” alternatives, which considered constructing a new roadway for SR 502 further north or south of the existing corridor, were studied. Four public open house meetings were held to gather public input on the range of alternatives being considered for the project on: March 27, 2007; May 9, 2007; June 14, 2007; and September 27, 2007. These public meetings resulted in strong public support for one “on corridor” alternative, which was forwarded for further detailed environmental study along with the no action alternative. As draft environmental discipline studies of the possible effects of the potential alternatives were conducted, it was determined that the widening of the SR 502 corridor may substantially affect the quality of the human and natural environment and may benefit from a more detailed analysis. Therefore, the FHWA and WSDOT elected to prepare an ETS.
The EIS will address, at a minimum, the no action alternative and the following action alternative:
The FHWA and WSDOT will evaluate all transportation, environmental, social, and economic effects of the alternatives. Potential areas of impact include: Natural and cultural resources; land use; social and economic elements; and, traffic and noise. All effects will be evaluated for both the construction period and the long-term period of operation. Indirect and cumulative impacts will also be evaluated. Measures to avoid, minimize, and mitigate any significant effects will be developed.
The date and address of the public scoping meeting is given in the
To ensure that a full range of issues related to this proposed action are addressed and all significant issues identified, comments and suggestions are invited from interested parties. Comments or questions concerning this proposal will be accepted at the public meeting or may be sent to the Washington State Department of Transportation Southwest Region at the address provided above.
In accordance with Section 236.913 of Title 49 of the Code of Federal Regulations (CFR), notice is hereby given that the Federal Railroad Administration (FRA) has received an informational filing from the Northeast Illinois Regional Commuter Railroad Corporation (Metra) to permit field testing of the railroad's processor-based train control system. The informational filing is described below, including the requisite docket number where the informational filing and any related information may be found. The document is also available for public inspection; however, FRA is not accepting public comments.
Metra has submitted an informational filing to permit field testing of the railroad's processor-based train control system identified as Electronic Train Management System (ETMS). The informational filing addresses the requirements under 49 CFR 236.913(j)(1).
Specifically, the informational filing contains a description of the ETMS product and an operational concepts document, pursuant to 49 CFR 236.913(j)(1). The ETMS is a locomotive-centric, non-vital system designed to be overlaid on existing methods of operation and to provide an improved level of railroad safety through enforcement of a train's authority limits and both permanent and temporary speed restrictions. An associated temporary waiver petition has also been submitted to support field testing of Metra's ETMS pursuant to 49 CFR Sections 211.7 and 211.51, and can be found in the same docket as this informational filing (FRA-2008-0057).
Metra desires to commence field testing on or about July 1, 2008, or as soon as practicable thereafter, contingent upon FRA's acceptance and approval of their informational filing. Metra intends to test and develop ETMS on its Rock Island District between Chicago, IL and Joliet, IL.
Interested parties are invited to review the informational filing and associated documents at DOT's Docket Management facility during regular business hours (9 a.m.-5 p.m.) at 1200 New Jersey Avenue, SE., Room W12-140, Washington, DC 20590. All documents in the public docket are available for inspection and copying on the internet at
Anyone is able to search the electronic form of any written communications received into any of our dockets by name of the individual submitting the document (or signing the document, if submitted on behalf of an association, business, labor union, etc.). You may review the DOT's complete Privacy Act Statement in the
In accordance with Part 211 of Title 49 Code of Federal Regulations (CFR), notice is hereby given that the Federal Railroad Administration (FRA) has received a request for temporary waiver of compliance with certain requirements of its safety standards. The individual petition is described below, including the party seeking relief, the regulatory provisions involved, and the nature of the relief being requested.
The Northeast Illinois Regional Commuter Railroad Corporation (Metra) has submitted a temporary waiver petition to support field testing of its processor-based train control system, identified as Electronic Train Management System (ETMS), pursuant to 49 CFR Sections 211.7 and 211.51.
An informational filing, as required under 49 CFR Part 236, Subpart H, has also been prepared and submitted in conjunction with this waiver petition, and can be found in the same docket as this waiver petition (FRA-2008-0057).
ETMS is a locomotive-centric, non-vital system, designed to be overlaid on
Metra is seeking regulatory relief for development testing and demonstration purposes only. Specifically, Metra is requesting regulatory relief from the following FRA requirements:
• 49 CFR 216.13 (Special Notice for Repairs—Locomotive);
• 49 CFR 217.9 (Program of Operational Tests and Inspections—Recordkeeping);
• 49 CFR 217.11 (Program of Instruction on Operating Rules—Recordkeeping, Electronic Recordkeeping);
• 49 CFR Part 218, Subpart D (Prohibition against Tampering with Safety Devices);
• 49 CFR 229.7 (Prohibited Acts);
• 49 CFR 229.135 (Event Recorders);
• 49 CFR 233.9 (Reports);
• 49 CFR 235.5 (Changes Requiring Filing of Application);
• 49 CFR 240.127 (Criteria for Examining Skill Performance); and
• 49 CFR 240.129 (Criteria for Monitoring Operational Performance of Certified Engineers).
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. All communications concerning these proceedings should identify the appropriate docket number (Docket Number FRA-2008-0057) and may be submitted by one of the following methods:
•
•
•
•
FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested party desires an opportunity for oral comment, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.
Communications received within 30 days of the date of this notice will be considered by FRA before final action being taken. Comments received after this period will be considered as far as practicable. All written communications concerning these proceedings are available for examination during regular business hours (9 a.m.-5 p.m.) at the DOT Docket Management Facility, 1200 New Jersey Avenue, SE., Room W12-140, in Washington, DC. All documents in the public docket are also available for inspection and copying on the internet at
Anyone is able to search the electronic form of any written communications and comments received into any of our dockets by name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review the DOT's complete Privacy Act Statement in the
Federal Transit Administration (FTA).
Notice to establish a system of records.
DOT intends to establish a system of records under the Privacy Act of 1974. The Privacy Act of 1974, as amended, 5 U.S.C. 552a, requires that agencies that maintain a system of records publish a notice in the
Habib Azarsina, Departmental Privacy Officer, S-80, United States Department of Transportation, Office of the Secretary of Transportation, 1200 New Jersey Ave, SE., Washington, DC 20590, telephone 202-366-1965 or
The Department of Transportation system of records notice subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended, has been published in the
The Operational Assets and Information Security (OASIS) System.
Unclassified, Non-Sensitive.
This system of record is in the Office of Information Technology for the Department of Transportation/Federal Transit Administration, Integrated Communication Solutions data center located at 5260 Westview Drive, Frederick, MD 21703.
FTA employees and contractors
Information maintained in this system consists of employee/contractor work information in the form of room number, work telephone number, and systems to which the employees have access. The system also stores employee/contractor home addresses and telephone numbers.
49 U.S.C. 321.
Employee/contractor personal information is encouraged in case of emergency where the individual's family may need to be reached. Input of this information is not mandatory and is provided at the individual's option. Also, no record subject is able to see the information of any other record subject.
See Prefatory Statement of General Routine Uses.
None.
Documents are stored electronically in a SQL Server database on the internal network (behind departmental firewall).
Records are retrieved by searching on an individual's name or office symbol.
OASIS is an FTA application that resides on the internal network behind the departmental firewall. Users are authenticated by their network user ID and password.
Data is kept in the system for the life of the system. Many of FTA's applications interface with OASIS and individuals who are no longer working for FTA are in an inactive status. This is necessary in order to maintain historical traceability in our applications.
Office of Information Technology (TAD-20), Federal Transit Administration, 1200 New Jersey Ave., SE., Washington, DC 20590.
Same as “System Manager.”
Same as “System Manager.”
Same as “System Manager.”
Personal information is entered voluntarily by the individual at her/his own discretion for emergency procedures.
None.
National Highway Traffic Safety Administration, U.S. Department of Transportation.
Notice.
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Comments must be submitted to OMB on or before July 7, 2008.
Send comments to the Office of Information and Regulatory Affairs, OMB, 725 17th Street, NW., Washington, DC 20503, Attention: Desk Officer.
Jennifer Timian, Recall Management Division (NVS-215), Room W46-324, NHTSA, 1200 New Jersey Ave., Washington, DC 20590. Telephone: (202) 366-0209.
• That a plan be filed explaining how the manufacturer intends to reimburse owners or purchasers who paid to remedy the defective or noncompliant product prior to its recall, and that this plan be explained in the notifications issued to owners and purchasers;
• That the manufacturer provide to NHTSA copies of communications pertaining to the recall campaign that they may issue to owners, purchasers, dealers, or distributors;
• That the manufacturer maintain a list of the owners, purchasers, dealers, and distributors it notified;
• That the manufacturer provide NHTSA with at least six quarterly reports detailing the progress of the recall campaign;
• Related to, in tire recall campaigns, the proper disposal of recalled tires, including requirements that the manufacturer submit a plan and provide certain information and instructions to certain persons (such as its dealers or retail outlets) addressing disposal, and a requirement that those persons report back deviations from that plan; and
• That any person who sells or leases a defective or noncompliant tire, knowing that the manufacturer has decided that tire is defective or noncompliant, report that sale or lease to NHTSA.
The statutory sections imposing these requirements include 49 U.S.C. 30118, 30119, 30120, and 30166. The regulatory sections implementing these statutory sections are found within 49 CFR part 573,
NHTSA published a
Comments are invited on: whether the proposed collection of information is necessary for the proper performance of the functions of the Department, including whether the information will have practical utility; the accuracy of
A comment to OMB is most effective if OMB receives it within 30 days of publication.
Motley Rice, LLC (Motley Rice), counsel of record for the plaintiffs in the lawsuit styled
Motley Rice contends that the identified vehicles are not in compliance with FMVSS No. 206. Specifically, the petitioner contends that the identified vehicles are not in compliance with the 30g (inertia load) requirement of FMVSS No. 206 as a result of a defect in the outside handle torsion spring. The spring tension in these handles, petitioner contends, is substantially below specification and may reduce the level for inertia activation of the system to approximately half that needed to meet the 30g calculation requirements of FMVSS No. 206 per the calculation referenced in Society of Automotive Engineers Recommended Practice J839 (SAE-J839).
Under the National Traffic and Motor Vehicle Safety Act, as amended and recodified, 49 U.S.C. 30112(a)(1), a person may not manufacture for sale or sell any motor vehicle manufactured on or after the date of an applicable motor vehicle safety standard takes effect unless the vehicle complies with the standard and is covered by a certification issued under 49 U.S.C. 30115. Except with regard to vehicles not manufactured to comply with the FMVSSs but later imported, the prohibition of section 30112(a) does not apply to the sale of a motor vehicle after the first purchase of the vehicle in good faith other than for resale. The FMVSSs generally apply to the manufacture and sale of new vehicles, as distinguished from used vehicles.
In general, NHTSA's enforcement of the FMVSSs is based on compliance testing of samples of new products conducted using the test procedures set forth in the relevant safety standard. However, manufacturers certifying compliance with FMVSSs are not required to follow exactly the compliance test procedures set forth in the applicable standard. Manufacturers are required to exercise reasonable care to assure compliance in making their certifications. 49 U.S.C. 30115(a). It may be simplest and is best for a manufacturer to establish that it exercised reasonable care if it has strictly followed NHTSA's test procedures. However, NHTSA has recognized that reasonable care might also be shown using modified procedures if the manufacturer could demonstrate that the modifications were not likely to have had a significant impact on test results. In addition, reasonable care might be shown using engineering analyses or computer simulations.
FMVSS No. 206,
The door latch shall not disengage from the fully latched position when a longitudinal or transverse inertia load of 30g is applied to the door latch system (including the latch and its actuating mechanism with the locking mechanism disengaged).
The accompanying compliance provision states:
S5.1.1.2.
SAE-J839 paragraph 6 specifies a 30g-based calculation. Apart from the SAE calculation, the only NHTSA-approved test
Ford certified the subject vehicles to the inertia load requirements of FMVSS No. 206 by using the SAE-J839 calculation. According to the petition, Ford thereafter determined that compliance (to the transverse inertia load requirement) could be demonstrated by using a modified version of the 1967 GM Dynamic Pulse Test Method; Ford used a computer-simulated program that relied upon the 1960 Severy acceleration pulse.
If NHTSA were to grant the Motley Rice petition, the agency would proceed to conduct a compliance investigation that might or might not result in an order to Ford under 49 U.S.C. 30118(b). In deciding whether to open a compliance or defect investigation, NHTSA considers, among other factors, allocation of agency resources, agency priorities, and the likelihood of success in litigation that might arise from an order the agency may issue. 49 CFR 552.8.
In this case, as discussed in further detail below, Ford has a simulation
Assuming that NHTSA were to undertake testing, there would be significant practical difficulties. The subject vehicles were sold to their first purchasers about eight or more years ago. Programmatically, NHTSA has tested new, rather than used, vehicles for compliance with FMVSSs because NHTSA's burden would be to demonstrate that the vehicle did not comply at the time of sale or offer for sale. It is extremely unlikely that new vehicles for the model years in question could be obtained. In view of these limiting circumstances, NHTSA could consider expending some of its limited funds to have a test vehicle or vehicle subassembly containing a new latch system assembly identical to the original Ford latch assembly manufactured. The specifics of the test assembly would have to be developed in conjunction with the development of the test procedure. Such an approach would be novel and might be challenged on various grounds, including whether testing was permissible and whether the test assembly replicated or was representative of latches in the subject vehicles.
Even if NHTSA decided to invest considerable resources and time in such an investigation, the agency could issue an order finding noncompliance only after giving Ford an opportunity for an administrative hearing, and the agency would have the burden of substantiating such an order in a
We have also considered safety issues presented by the latches in our testing and in our database. Our review of available New Car Assessment Program (NCAP) vehicle side impact test data included results for the MY 1999 Ford F150, and MY 2000 Ford F150 extended cab. Each vehicle tested yielded the highest government safety rating of 5-Stars for side impact protection and none of the results from these tests indicated that door unlatching occurred.
Lastly, our review of consumer complaints filed with NHTSA for the model year motor vehicles identified in the subject petition yielded only two cases potentially related to inertia door opening, one of which involved a severe 50 mph rollover crash. Given the three million-plus sales volume for the subject vehicles, the number of years of exposure already experienced by these vehicles, and the low number of alleged incidents reported to the agency, it does not appear that these vehicles are experiencing performance issues in the field.
In view of the available safety-related information that does not indicate the existence of a safety problem, the plausible position taken by Ford with regard to the vehicle's compliance, the substantial resources that would be required to address this matter in detail, and the agency's need to allocate its resources carefully to address issues involving appreciable safety risks, NHTSA has concluded that no further action is warranted. Therefore, the petition is denied.
49 U.S.C. 30162(d); delegations of authority at CFR 1.50 and 501.8.
National Highway Traffic Safety Administration (NHTSA), DOT.
Meeting Notice—Federal Interagency Committee on Emergency Medical Services.
NHTSA announces a meeting of the Federal Interagency Committee on Emergency Medical Services to be held in Washington, DC. This notice announces the date, time and location of the meeting, which will be open to the public.
The meeting will be held on June 23, 2008, from 10 a.m. to 12 Noon.
The meeting will be held at the Department of Homeland Security (DHS), Office of Health Affairs, 1120 Vermont Avenue, NW., 4th Floor-Conference Room #1, Washington, DC 20005.
Drew Dawson, Director, Office of Emergency Medical Services, National Highway Traffic Safety Administration, 1200 New Jersey Avenue, SE., NTI-140, Washington, DC 20590; Telephone number (202) 366-9966; E-mail
Section 10202 of the Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy For Users (SAFETEA-LU), Public Law 109-59, provided that the FICEMS consist of several officials from Federal agencies as well as a State emergency medical services director appointed by the Secretary of Transportation. SAFETEA-LU directed the Administrator of NHTSA, in cooperation with the Administrator of the Health Resources and Services Administration of the Department of Health and Human Services and the Director of the Preparedness Division, Directorate of Emergency Preparedness and Response of the Department of Homeland Security, to provide administrative support to the Interagency Committee, including scheduling meetings, setting agendas, keeping minutes and records, and producing reports.
This meeting of the FICEMS will focus on addressing the requirements of SAFETEA-LU and the opportunities for collaboration among the key Federal
• Consideration of the FICEMS Technical Working Group report and recommendations
• Evidence-based Practice Guidelines Process Conference
• Report to Congress discussion
• Briefing on and discussion of the National EMS Information System (NEMSIS)
• Reports, updates, recommendations from FICEMS members
• Report from the National EMS Advisory Council
This meeting will be open to the public. Individuals wishing to register must provide their name, affiliation, phone number, and e-mail address to Drew Dawson by e-mail at
Minutes of the FICEMS Meeting will be available to the public online through the DOT Document Management System (DMS) at:
Chrysler, LLC (Chrysler) has determined that certain vehicles that it manufactured during the period of March 14, 2006 through March 20, 2008, do not fully comply with paragraph S4.3 of 49 CFR 571.110 (Federal Motor Vehicle Safety Standard (FMVSS) No. 110
Pursuant to 49 U.S.C. 30118(d) and 30120(h) (see implementing rule at 49 CFR part 556), Chrysler 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 Chrysler'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.
Affected are approximately 1,886 model year 2007-2008 Jeep Wrangler right-hand drive (RHD) multipurpose passenger vehicles (MPV).
Paragraphs S4.3 of 49 CFR 571.110 requires in pertinent part that:
S4.3 Placard. Each vehicle, except for a trailer or incomplete vehicle, shall show the information specified in S4.3 (a) through (g), and may show, at the manufacturer's option, the information specified in S4.3 (h) and (i), on a placard permanently affixed to the driver's side B-pillar. In each vehicle without a driver's side B-pillar and with two doors on the driver's side of the vehicle opening in opposite directions, the placard shall be affixed on the forward edge of the rear side door. If the above locations do not permit the affixing of a placard that is legible, visible and prominent, the placard shall be permanently affixed to the rear edge of the driver's side door. If this location does not permit the affixing of a placard that is legible, visible and prominent, the placard shall be affixed to the inward facing surface of the vehicle next to the driver's seating position. This information shall be in the English language and conform in color and format, not including the border surrounding the entire placard, as shown in the example set forth in Figure 1 in this standard. At the manufacturer's option, the information specified in S4.3 (c), (d), and, as appropriate, (h) and (i) may be shown, alternatively to being shown on the placard, on a tire inflation pressure label which must conform in color and format, not including the border surrounding the entire label, as shown in the example set forth in Figure 2 in this standard. The label shall be permanently affixed and proximate to the placard required by this paragraph. The information specified in S4.3 (e) shall be shown on both the vehicle placard and on the tire inflation pressure label (if such a label is affixed to provide the information specified in S4.3 (c), (d), and, as appropriate, (h) and (i)) may be shown in the format and color scheme set forth in Figures 1 and 2.
Chrysler stated that the noncompliance is that the required placard was installed on the passenger's side (left side) door on each of the subject RHD vehicles, not on the driver's side (right side) door or B-pillar as required by FMVSS No. 110.
Chrysler explains that the subject vehicles were sold primarily for use by rural postal carriers, since RHD makes it easier for the carriers to access mailboxes located along the right side of the roadway. The relevant portion of S4.3 of FMVSS No. 110, entitled “Placard,” provides as follows: “Each vehicle, except for a trailer or incomplete vehicle, shall show the information specified in S4.3(a) through (g) * * * on a placard permanently affixed to the driver's side B-pillar. In each vehicle without a driver's side B-pillar and with two doors on the driver's side of the vehicle opening in opposite directions, the placard shall be affixed on the forward edge of the rear side door. If the above locations do not permit the affixing of a placard that is legible, visible and prominent, the placard shall be permanently affixed to the rear edge of the driver's side door.”
Chrysler further explained that the subject vehicles have placards that contain all of the tire and vehicle loading information required by the various subsections of S4.3. However, because of an inadvertent failure of the assembly plant work instructions to differentiate between RHD and left hand drive (LHD) vehicles in this respect, the placards were inadvertently affixed to the rear edge of the door on the left (passenger) side of the subject vehicles, as opposed to the driver's side door. (Chrysler notes that the subject vehicles do not have a B-pillar with a flat surface that would permit the affixing of a placard that is “legible, visible, and prominent.”)
Chrysler states its belief that the fact that the placard required by paragraph S4.3 of the standard was affixed to the left hand door of these RHD vehicles—as opposed to the driver's side door—creates absolutely no risk to motor vehicle safety. All of the relevant tire and loading information is set forth on the placard, and therefore it is readily available to vehicle operators. Moreover, the placard is located at the place where United States drivers are used to looking for it.
Chrysler also states its belief that the operators of the subject vehicles will have almost certainly owned and driven conventional LHD vehicles, so they will have had experience in locating the tire and load information on the left side of their vehicles. And in the extremely unlikely event that an owner has difficulty locating the placard, the owner's manual provided with the subject vehicles shows the location of the placard on the left side door.
Chrysler also makes reference to several previous NHTSA inconsequential noncompliance decisions that in its opinion are similar to the instant one.
Chrysler also notes that it has not received any consumer complaints
In addition, Chrysler states that it has corrected the problem that caused these errors so that they will not be repeated in future production and that it believes that because the noncompliance is inconsequential to motor vehicle safety that no corrective action is warranted.
NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and 30120(h)) that permit manufacturers to file petitions for a determination of inconsequentiality allow NHTSA to exempt manufacturers only from the duties found in sections 30118 and 30120, respectively, to notify owners, purchasers, and dealers of a defect or noncompliance and to remedy the defect or noncompliance.
Interested persons are invited to submit written data, views, and arguments on this petition. 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:
a.
b.
c.
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. Please note that we are allowing just 10 days for comment in order to expedite resolution of this matter. 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 CFR 1.50 and 501.8.
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
Notice; Issuance of Advisory Bulletin.
This document advises operators of gas distribution pipeline systems of a statutory requirement for installation of excess flow valves in certain gas service lines.
Mike Israni by phone at (202) 366-4571 or by e-mail at
The Pipeline Inspection, Protection, Enforcement, and Safety (PIPES) Act of 2006 (Pub. L. 109-468) addresses the installation of excess flow valves (EFV) in certain gas service lines. An EFV is a safety device that can terminate flow of gas through a pipeline when the flow rate exceeds its design level, such as when the pipe ruptures or is broken (e.g., by excavation damage) downstream of the valve. A service line is a small-diameter pipeline that carries gas from a distribution main (often located below city streets) to individual residences and businesses where gas is used. Thus, EFVs can protect individual gas customer properties from the consequences of a break in the service line associated with their property.
Section 9 of the PIPES Act directs PHMSA to require operators of natural gas distribution systems to install EFVs in selected service lines that are installed or entirely replaced after June 1, 2008. The requirement applies to those service lines that operate continuously throughout the year at a pressure not less than 10 pounds per square inch (psi), that are not connected to a gas stream with respect to which the operator has had prior experience of contaminants that could interfere with operation of an EFV, where the installation of an EFV is not likely to result in a loss of service or interference with required maintenance actions, and where a valve of appropriate size and performance is commercially available. The PIPES Act directs PHMSA to include this requirement in a regulation requiring that distribution pipeline system operators establish integrity management programs.
PHMSA is still working on its proposed regulation addressing distribution integrity management programs (DIMP). That regulation is complex and has taken longer than anticipated to develop. As a result, the regulation will not be in place before the June 1, 2008, deadline specified in the Act for installation of EFVs on the affected service lines. Nevertheless, gas distribution pipeline operators should be aware of the statutory requirement and are encouraged to install EFVs on service lines that are newly installed or completely replaced after June 1, 2008, and that meet the criteria specified in the PIPES Act.
• That are installed or entirely replaced after June 1, 2008;
• That operate continuously throughout the year at a pressure not less than 10 psi gauge;
• That are not connected to a gas stream with respect to which the operator has had prior experience with contaminants the presence of which could interfere with the operation of an EFV, and
• For which an excess flow valve meeting the performance standards of 49 CFR 192.381 is commercially available.
The PIPES Act directs the Pipeline and Hazardous Materials Safety Administration (PHMSA) to include this requirement in a regulation addressing distribution integrity management programs (DIMP). PHMSA is working on its DIMP regulation and expects a proposed rule to be published shortly. PHMSA intends to analyze public comments and prepare a final rule in an
PHMSA encourages all gas distribution pipeline operators to take actions to ensure that EFVs are installed on the appropriate service lines that are installed or completely replaced after June 1, 2008.
R.J. Corman Railroad Company/Pennsylvania Lines Inc. (RJCP), a Class III rail carrier, has filed a verified notice of exemption under 49 CFR 1150.41 to acquire by purchase from Norfolk Southern Railway Company (NS)
RJCP intends to operate rail service over the Eastern Segment.
Based on projected revenues for the line being acquired, RJCP expects to remain a Class III rail carrier after consummation of the proposed transaction. RJCP certifies that its projected annual revenues as a result of this transaction will not result in the creation of a Class II or Class I rail carrier.
Because the projected annual revenues of the lines, together with RJCP's projected annual revenue, will exceed $5 million, RJCP is required, at least 60 days before an exemption is to become effective, to send notice of the transaction to the national and local offices of the labor unions with employees on the affected lines and post a copy of the notice at the workplace of the employees on the affected lines and certify to the Board that it has done so. 49 CFR 1150.42(e). However, RJCP has noted that there are no affected employees as there is no current rail line. Therefore, RJCP has filed for a waiver from the requirements of 49 CFR 1150.42(e). RJCP states in the waiver request that the track materials on the line have been removed, no rail operations have been conducted for at least 15 years, and no railroad workers have been employed on the line for at least the same period of time. RJCP's waiver request will be handled in a subsequent decision.
The Board will establish in the decision on the waiver request the earliest this transaction may be consummated. RJCP states that it intends to consummate the transaction only following approval of RJCP's petition for exemption in STB Finance Docket No. 35116.
If the notice contains false or misleading information, the exemption is void
Pursuant to the Consolidated Appropriations Act, 2008, Public Law 110-161 section 193, 121 Stat. 1844 (2007), nothing in this decision authorizes the following activities at any solid waste rail transfer facility: collecting, storing, or transferring solid waste outside of its original shipping container; or separating or processing solid waste (including baling, crushing, compacting, and shredding). The term “solid waste” is defined in section 1004 of the Solid Waste Disposal Act, 42 U.S.C. 6903.
An original and 10 copies of all pleadings, referring to STB Finance Docket No. 35143, must be filed with the Surface Transportation Board, 395 E Street, SW., Washington, DC 20423-0001. In addition, one copy of each pleading must be served on Ronald A. Lane, Fletcher & Sippel LLC, 29 North Wacker Drive, Suite 920, Chicago, IL 60606-2832.
Board decisions and notices are available on our Web site at
By the Board, David M. Konschnik, Director, Office of Proceedings.
Research and Innovative Technology Administration (RITA), Bureau of Transportation Statistics (BTS), DOT.
Notice.
In compliance with the Paperwork Reduction Act of 1995, Public Law 104-13, the Bureau of Transportation Statistics invites the general public, industry and other governmental parties to comment on the continuing need for and usefulness of DOT requiring U.S. and foreign air carriers to file traffic and capacity data pursuant to 14 CFR 241.19 and Part 217, respectively. These reports are used to measure air transportation activity to, from, and within the United States.
Written comments should be submitted by August 4, 2008.
You may submit comments identified by DOT Docket ID Number
An electronic copy of this rule, a copy of the notice of proposed rulemaking, and copies of the comments may be downloaded at
Mr. Bernard Stankus, Office of Airline Information, RTS-42, Bureau of Transportation Statistics, Research and Innovative Technology Administration, 1200 New Jersey Avenue, SE., Washington, DC 20590-0001, Telephone Number (202) 366-4387, Fax Number (202) 366-3383 or E-mail
The Federal Aviation Administration uses enplanement data for U.S. airports to distribute the annual Airport Improvement Program (AIP) entitlement funds to eligible primary airports, i.e., airports which account for more than 0.01 percent of the total passengers enplaned at U.S. airports. Enplanement data contained in Schedule T-100/T-100(f) are the sole data base used by the FAA in determining airport funding. U.S. airports receiving significant service from foreign air carriers operating small aircraft could be receiving less than their fair share of AIP entitlement funds. Collecting Schedule T-100(f) data for small aircraft operations will enable the FAA to more fairly distribute these funds.
The FAA uses traffic, operational and capacity data as important safety indicators and to prepare the air carrier traffic and operation forecasts that are used in developing its budget and staffing plans, facility and equipment funding levels, and environmental impact and policy studies. The FAA monitors changes in the number of air carrier operations as a way to allocate inspection resources and in making decisions as to increased safety surveillance. Similarly, airport activity statistics are used by the FAA to develop airport profiles and establish priorities for airport inspections.
While the Justice Department has the primary responsibility over air carrier acquisitions and mergers, the Department reviews the transfer of international routes involved to determine if they would substantially reduce competition, or determine if the transaction would be inconsistent with the public interest. In making these determinations, the proposed transaction's effect on competition in the markets served by the affected air carriers is analyzed. This analysis includes, among other things, a consideration of the volume of traffic and available capacity, the flight segments and origins-destinations involved, and the existence of entry barriers, such as limited airport slots or gate capacity. Also included is a review of the volume of traffic handled by each air carrier at specific airports and in specific markets which would be affected by the proposed acquisition or merger. The Justice Department uses T-100 data in carrying out its responsibilities relating to airline competition and consolidation.
Recently, the House and Senate Subcommittees on Aviation have reviewed market data in assessing possible mergers between major airlines.
The FAA uses traffic, operational and capacity data as important safety indicators and to prepare the air carrier traffic and operation forecasts. These forecasts are used by the FAA, airport managers, the airlines and others in the air travel industry as planning and budgeting tools.
The mix of aircraft type are used in determining the practical annual capacity (PANCAP) at airports as prescribed in the FAA Advisory Circular
The Department apprises Congress, the Administration and others of the effect major changes or innovations are having on the air transportation industry. For this purpose, summary traffic and capacity data as well as the detailed segment and market data are essential. These data must be timely and inclusive to be relevant for analyzing emerging issues and must be based upon 6 uniform and reliable data submissions that are consistent with the Department's regulatory requirements.
The Department is responsible for establishing international and intra-Alaska mail rates. International mail rates are set based on scheduled operations in four geographic areas: Trans-border, Latin America, operations
The Department reassesses service levels at small domestic communities to assure that capacity levels are adequate to accommodate current demand.
The FAA is charged with administering a series of grants that are designed to accomplish the necessary airport planning for future development and growth. These grants are made to state metropolitan and regional aviation authorities to fund needed airport systems planning work. Individual airport activity statistics, nonstop market data, and service segment data are used to prepare airport activity level forecasts.
The Department reviews all of the International Air Transport Association (IATA) agreements that relate to fares, rates, and rules for international air transportation to ensure that the agreements meet the public interest criteria. Current and historic summary traffic and capacity data, such as revenue ton-miles and available ton-miles, by aircraft type, type of service, and length of haul are needed to conduct these analyses to: (1) Develop the volume elements for passenger/cargo cost allocations, (2) evaluate fluctuations in volume of scheduled and charter services, (3) assess the competitive impact of different operations such as charter versus scheduled, (4) calculate load factors by aircraft type, and (5) monitor traffic in specific markets.
Foreign air carriers are required to submit applications for authority to operate to the United States. In reviewing these applications the Department must find that the requested authority is encompassed in a bilateral agreement, other intergovernmental understanding, or that granting the application is in the public interest. In the latter cases, T-100 data are used in assessing the level of benefits that carriers of the applicant's homeland presently are receiving from their U.S. operations. These benefits are compared and balanced against the benefits U.S. carriers receive from their operations to the applicant's homeland.
The Department determines whether U.S. air carriers are and continue to be fit, willing and able to conduct air service operations without undue risk to passengers and shippers. The Department monitors a carrier's load factor, operational, and enplanement data to compare with other carriers with similar operating characteristics. Carriers that expand operations at a high rate are monitored more closely for safety reasons.
Pursuant to an international agreement, the United States is obligated to report certain air carrier data to the International Civil Aviation Organization (ICAO). The traffic data supplied to ICAO are extracted from the U.S. air carriers' Schedule T-100 submissions.
The Confidential Information Protection and Statistical Efficiency Act of 2002 (44 U.S.C. 3501 note), requires a statistical agency to clearly identify information it collects for non-statistical purposes. BTS hereby notifies the respondents and the public that BTS uses the information it collects under this OMB approval for non-statistical purposes including, but not limited to, publication of both Respondent's identity and its data, submission of the information to agencies outside BTS for review, analysis and possible use in regulatory and other administrative matters.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Revenue Procedure 2005-26, Revenue Procedure Regarding Extended Period of Limitation for Listed Transaction Situations.
Written comments should be received on or before August 4, 2008 to be assured of consideration.
Direct all written comments to Glenn Kirkland, Internal Revenue Service, room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224.
Requests for additional information or copies of the regulations should be directed to Allan Hopkins at Internal Revenue Service, room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224, or at (202) 622-6665, or through the Internet at
The following paragraph applies to all the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 637, Application for Registration (For Certain Excise Tax Activities).
Written comments should be received on or before August 4, 2008 to be assured of consideration.
Direct all written comments to Glenn Kirkland, Internal Revenue Service, room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224.
Requests for additional information or copies of the form and instructions should be directed to Allan Hopkins at (202) 622-6665, or at Internal Revenue Service, room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224, or through the Internet at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Notice 2005-41, Guidance Regarding Qualified Intellectual Property Contributions.
Written comments should be received on or before August 4, 2008 to be assured of consideration.
Direct all written comments to Glenn P. Kirkland, Internal Revenue Service, room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224.
Requests for additional information or copies of notice should be directed to Allan Hopkins at (202) 622-6665, or at Internal Revenue Service, room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224, or through the internet, at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 8697, Interest Computation Under the Look-Back Method for Completed Long-Term Contracts.
Written comments should be received on or before August 4, 2008 to be assured of consideration.
Direct all written comments to Glenn Kirkland, Internal Revenue Service, room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224.
Requests for additional information or copies of the form and instructions should be directed to Allan Hopkins at Internal Revenue Service, room 6512, 1111 Constitution Avenue, NW., Washington, DC 20224, or at (202) 622-6665, or through the internet at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 12884, Survey Questionnaire.
Written comments should be received on or before August 4, 2008 to be assured of consideration.
Direct all written comments to Glenn Kirkland, Internal Revenue Service, room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224.
Requests for additional information or copies of the forms and instructions should be directed to Allan Hopkins at (202) 622-6665, or at Internal Revenue Service, room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224, or through the internet, at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 1099-DIV, Dividends and Distributions.
Written comments should be received on or before August 4, 2008 to be assured of consideration.
Direct all written comments to Glenn Kirkland, Internal Revenue Service, room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224.
Requests for additional information or copies of the form and instructions should be directed to Allan Hopkins at Internal Revenue Service, room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224, or at (202) 622-6665, or through the internet at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 12854, Prior Government Service Information.
Written comments should be received on or before August 4, 2008 to be assured of consideration.
Direct all written comments to Glenn Kirkland, Internal Revenue Service, room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224.
Requests for additional information or copies of the forms and instructions should be directed to Allan Hopkins at (202) 622-6665, or at Internal Revenue Service, room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224, or through the internet, at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Internal Revenue Service (IRS), Treasury.
Notice.
This document contains a Notice that the IRS has made available the grant application package and guidelines (Publication 3319) for organizations interested in applying for a Low Income Taxpayer Clinic (LITC) matching grant for the 2009 grant cycle (the 2009 grant cycle runs January 1, 2009, through December 31, 2009). The application period shall run from May 27, 2008, through July 7, 2008.
The IRS will award a total of up to $6,000,000 (unless otherwise provided by specific Congressional appropriation) to qualifying organizations, subject to the limitations of Internal Revenue Code section 7526, for matching grants. A qualifying organization may receive a matching grant of up to $100,000 per year. Qualifying organizations that provide representation for free or for a nominal fee to low income taxpayers involved in tax controversies with the IRS or that provide education on taxpayer rights and responsibilities to taxpayers for whom English is a second language can apply for a grant for the 2009 grant cycle.
Examples of qualifying organizations include: (1) Clinical programs at accredited law, business or accounting schools, whose students represent low income taxpayers in tax controversies with the IRS, and (2) organizations exempt from tax under I.R.C. § 501(a) which represent low income taxpayers in tax controversies with the IRS or refer those taxpayers to qualified representatives.
Grant applications for the 2009 grant cycle must be electronically filed or postmarked by July 7, 2008.
Send completed grant applications to: Internal Revenue Service, Taxpayer Advocate Service, LITC Grant Program Administration Office, TA:LITC, 1111 Constitution Avenue, NW., Room 1034, Washington, DC 20224. Copies of the
The LITC Program Office at (202) 622-4711 (not a toll-free number) or by e-mail at
Section 7526 of the Internal Revenue Code authorizes the IRS, subject to the availability of appropriated funds, to award organizations matching grants of up to $100,000 per year for the development, expansion, or continuation of qualified low income taxpayer clinics. Section 7526 authorizes the IRS to provide grants to qualified organizations that represent low income taxpayers in controversies with the IRS or inform individuals for whom English is a second language of their taxpayer rights and responsibilities. The IRS may award grants to qualifying organizations to fund one-year, two-year or three-year project periods. Grant funds may be awarded for start-up expenditures incurred by new clinics during the grant cycle.
The
The costs of preparing and submitting an application are the responsibility of each applicant. Each application will be given due consideration and the LITC Program Office will mail notification letters to each applicant.
Applications that pass the eligibility screening process will be numerically ranked based on the information contained in their proposed program plan. Please note that the IRS Volunteer Income Tax Assistance (VITA) and Tax Counseling for the Elderly (TCE) Programs are independently funded and separate from the LITC Program. Organizations currently participating in the VITA or TCE Programs may be eligible to apply for a LITC grant if they meet the criteria and qualifications outlined in the
Interested parties are encouraged to provide comments on the IRS's administration of the grant program on an ongoing basis. Comments may be sent to Internal Revenue Service, Taxpayer Advocate Service, Attn: Shawn Collins, LITC Program Office, TA:LITC, 1111 Constitution Avenue, NW., Room 1034, Washington, DC 20224.
Notice is hereby given that on May 14, 2008, the Office of Thrift Supervision approved the application of Home Federal Mutual Holding Company of Louisiana and Home Federal Savings and Loan Association, Shreveport, Louisiana, to convert to the stock form of organization. Copies of the application are available for inspection by appointment (phone number: 202-906-5922 or e-mail:
By the Office of Thrift Supervision,
Centers for Medicare & Medicaid Services (CMS), HHS.
Final rule.
This final rule revises the existing conditions of participation that hospices must meet to participate in the Medicare and Medicaid programs. The final conditions address the comments that we received on the proposed rule published on May 27, 2005. This final rule focuses on the care delivered to patients and their families by hospices and the outcome of that care. The final requirements continue to reflect the unique interdisciplinary view of patient care and allow hospices flexibility in meeting quality standards. These changes are an integral part of the Administration's efforts to achieve broad based improvements in the quality of health care and our efforts to improve the quality of care furnished through the Medicare and Medicaid programs.
These regulations are effective on December 2, 2008.
The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of December 2, 2008.
Steve Miller, (410) 786-6656; Mary Rossi-Coajou, (410) 786-6051; Danielle Shearer, (410) 786-6617; or Jeannie Miller, (410) 786-3164.
Hospice care is an approach to caring for the terminally ill individual that provides palliative care rather than traditional medical care and curative treatment. Palliative care is an approach that improves the quality of life of patients and their families facing the problems associated with life-threatening illness through the prevention and relief of suffering by means of early identification, assessment and treatment of pain and other issues. Hospice care allows the patient to remain at home as long as possible by providing support to the patient and family, and by keeping the patient as comfortable as possible while maintaining his or her dignity and quality of life. A hospice uses an interdisciplinary approach to deliver medical, social, physical, emotional, and spiritual services through the use of a broad spectrum of caregivers.
Section 122 of the Tax Equity and Fiscal Responsibility Act of 1982 (TEFRA), Public Law 97-248, added section 1861(dd) to the Social Security Act (the Act) to provide coverage for hospice care to terminally ill Medicare beneficiaries who elect to receive care from a Medicare-participating hospice. Under the authority of section 1861(dd) of the Act, the Secretary has established the Conditions of Participation (CoPs) that a hospice must meet to participate in Medicare and/or Medicaid, and these conditions are set forth at 42 CFR part 418. The CoPs apply to a hospice as an entity as well as to the services furnished to each individual under hospice care. Under section 1861(dd) of the Act, the Secretary is responsible for ensuring that the CoPs, and their enforcement, are adequate to protect the health and safety of individuals under hospice care. To implement this requirement, State survey agencies conduct surveys of hospices to assess their compliance with the CoPs.
The hospice CoPs were originally published on December 16, 1983 (48 FR 56008) and were amended on December 11, 1990 (55 FR 50831) largely to implement provisions of section 6005(b) of the Omnibus Budget Reconciliation Act of 1989 (Pub. L. 101-239). However, many of the current CoPs have remained unchanged since their inception.
As the single largest payer for health care services in the United States, the Federal Government assumes a critical responsibility for the delivery and quality of care furnished under its programs. Historically, we have adopted a quality assurance approach that has been directed toward identifying health care providers that furnish poor quality care or fail to meet minimum Federal standards. These problems would either be corrected or would lead to the exclusion of the provider from participation in the Medicare or Medicaid programs. However, we have found that this problem-focused approach has inherent limits. Ensuring quality through the enforcement of prescriptive health and safety standards, rather than improving the quality of care for all patients, has resulted in our expending much of our resources on dealing with marginal providers, rather than on stimulating broad-based improvements in quality of care.
In order to take advantage of continuing advances in the health care delivery field, incorporate changes made to the Act, and incorporate recommendations made by various government agencies we are revising the Medicare hospice CoPs, which are also used by Medicaid. The revised CoPs focus on a patient-centered, outcome-oriented, and transparent process that promotes quality patient care for every patient every time.
We have developed a set of core requirements for hospice services that encompass the following: Patient rights, comprehensive assessment, patient care planning and coordination by a hospice interdisciplinary group (IDG). Overarching these requirements is a quality assessment and performance improvement program that builds on the philosophy that a provider's own quality management system is key to improved patient care performance. The objective is to achieve a balanced regulatory approach by ensuring that a hospice furnishes health care that meets essential health and quality standards, while ensuring that it monitors and improves its own performance.
We are revising the CoPs based on four main considerations. First, we considered the recommendations from the Secretary's Advisory Committee on Regulatory Reform. In an effort to make regulations more predictable and responsive to relevant stakeholders, the Committee heard public testimony on a variety of hospice-related topics and developed recommendations to address key issues that were highlighted. The Committee recommended that we clarify the relationship between nursing facilities and hospices (found in our final rule at § 418.112); change the requirements for 24-hour nursing services for hospices providing respite care (§ 418.108 of the final rule); and clarify that all qualified individuals, including nurses, are permitted to furnish dietary counseling (§ 418.64(d)(2) of the final rule).
Second, we considered the Balanced Budget Act of 1997 (Pub. L. 105-33) because it made changes to the hospice statute that must now be incorporated into the CoPs. Specifically, the Balanced Budget Act of 1997 (BBA) permitted hospices to provide physician services, including those of a medical director, under contract (§ 418.64 and § 418.102 of the final rule). It also allowed hospices located in non-urbanized areas to receive a waiver of the requirement that physical therapy, occupational therapy, speech-language pathology, and dietary counseling be available on a 24-hour as needed basis (§ 418.74 of the final rule). Additionally, the
Third, we considered section 946 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173). Section 946 of the MMA amended section 1861(dd) of the Act, to permit a hospice to enter into an arrangement with another hospice to provide core hospice services or to provide the highly specialized services of a registered professional nurse, in certain circumstances (§ 418.64 of the final rule).
Finally, this revision is part of a larger effort to bring about improvements in the quality of care furnished to hospice patients and their families through an outcome-oriented approach to patient care. The revised CoPs focus on the core elements of hospice care that are necessary to achieve positive patient outcomes to meet the growing challenges associated with the changing hospice care environment such as increasingly diverse patient populations and care settings.
Before developing the proposed CoPs for hospices, published in the
• Focus on the continuous, integrated health care process that a patient/family experiences across all aspects of hospice care, and on activities that center around patient assessment, care planning, service delivery, and quality assessment and performance improvement;
• Use a patient-centered, interdisciplinary approach that recognizes the contributions of various skilled professionals and other support personnel and their interaction with each other to meet the patient's needs;
• Incorporate an outcome-oriented quality assessment and performance improvement program;
• Facilitate flexibility in how a hospice meets performance expectations;
• Require that patient rights are ensured; and
• Use performance measurement systems to evaluate and improve care.
Based on these principles and the public comments that were submitted regarding the May 2005 proposed rule, we are setting forth this final rule.
On May 27, 2005, we set forth proposed rules for hospices that choose to participate in Medicare and Medicaid. We proposed to revise all of the existing conditions of participation (CoPs), and to add several new CoPs to address aspects of hospice care that we believe need attention. This section will briefly describe the content of each CoP in the proposed rule.
We proposed no changes to Subparts B (Eligibility, Election and Duration of Benefits), G (Payment for Hospice Care), or H (Coinsurance) of 42 CFR part 418.
We received 205 timely items of correspondence that raised numerous issues. These comments, detailed below, came from accrediting bodies, consumer advocacy organizations, hospices, individuals, national health care provider organizations, State agencies, and State health care provider organizations.
We proposed to revise § 418.2 to reflect the reorganization of the part and to include an introductory statement describing the purpose of the part. We did not receive any comments on this section. Therefore, we are adopting the provisions as proposed.
We proposed to remove, revise, and add numerous definitions to this section in order to clarify the meaning of the proposed rule. We proposed to move the definitions of “physician” and “social worker” from the definitions section to the personnel requirements section at § 418.114 because the definitions set forth the standards that these individuals must meet in order to function in a hospice. In addition, as it is not a condition of participation, and is only used for hospice payment purposes, we proposed to maintain the existing definition of the term “cap period.”
We proposed to revise the definitions of the terms “attending physician”, “bereavement counseling”, “employee”, “hospice”, “representative”, and “terminally ill”. Finally, we proposed to add definitions for the following terms: “clinical note”, “drug restraint”, “hospice care”, “licensed professional”, “palliative care”, “physical restraint”, “progress note”, “restraint”, “satellite location”, and “seclusion”.
We proposed to add nurse practitioners to the definition of “attending physician” because section 408 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) changed the statutory definition of “attending physician” to include nurse practitioners with respect to some (but not all) aspects of hospice services.
The terms “drug restraint”, “physical restraint”, and “seclusion” were presented for the first time in the proposed rule. Seclusion and restraint requirements were proposed because anecdotal evidence suggested that there are occasions when hospice inpatient facilities must use seclusion and/or restraints for patient and/or staff safety. Moreover, Section 591 of the Public Health Service (PHS) Act, as added by the Children's Health Act (Pub. L. 106-310), prohibits the use of restraint and seclusion, except under specific circumstances, in any health care facility, that receives support in any form from any program supported in whole or in part with funds appropriated to any Federal department or agency.
We proposed to define the term “satellite location” to codify long-standing Medicare survey and certification policies that permit hospices to operate multiple locations under a single provider number. Multiple locations were not an issue when the hospice CoPs were originally implemented, and, as such, were not addressed. We believed that the proposed definition would help hospices determine when they do or do not need to obtain Medicare approval for a new location and what criteria would be used by Medicare in approving or denying a multiple location application.
We do not believe that it is necessary to state in the definition that an attending physician may be an employee of the hospice. The decision as to who is or is not the attending physician belongs to the patient regardless of that individual's employment relationship (or lack thereof) with the hospice. We do not prohibit attending physicians from being hospice employees as long as it is the patient's choice to decide whether or not to have an attending physician and who that attending physician will be during the patient's hospice care. In addition to consulting with the hospice interdisciplinary group (IDG) regarding the patient's hospice care, the attending physician retains responsibility for meeting the patient's needs that are not related to the terminal illness and that terminal illness's related conditions. The attending physician is typically someone with whom the patient had a relationship before electing to receive hospice care. The role of the attending physician is to provide a long term perspective on the patient and family that takes into account their medical and personal history. The attending physician is not typically an individual provided by the hospice to fill this role because a patient does not have an attending physician, although we recognize that this does occur at times.
We also do not believe that it is necessary to state that a nurse practitioner may act on behalf of the attending physician in the attending physician's absence. If the attending physician is unable to fulfill his or her duties, then the hospice physicians are responsible for fulfilling the attending physician's duties in his or her absence in accordance with § 418.64(a)(3) of the final rule. Therefore, there is no need for the attending physician to designate another individual to cover his or her hospice patients. The role and function of the nurse practitioner is also addressed in CMS hospice payment policies (see, for example, 42 CFR 418.304(e)).
With respect to counseling immediate family members, current practice in many hospices is expanding this activity. Many hospice programs have extensive bereavement programs that extend beyond immediate family members to embrace other caregivers, friends, and the larger community. As the commenter pointed out, the statute at section 1861(dd)(2)(A)(i) of the Act mandates bereavement counseling for the immediate family of the terminally ill individuals, but does not explicitly limit counseling to only such family members. We believe that limiting counseling to immediate family members would disregard the work that many hospices do for other persons whose relationship with the patient is important. To restrict bereavement counseling to a select few would discourage hospices from providing this service, thus harming the bereaved and the larger community. Therefore, we did not insert language limiting the definition of “bereavement counseling” to immediate family members. Bereavement counseling is part of the hospice's bundled daily payment rate.
In order to facilitate bereavement counseling services beginning at an early time and being furnished to whomever the hospice assesses as needing services, we believe that it is necessary to allow hospices flexibility in deciding who is qualified to provide bereavement services in accordance with their own policies, current standards of practice, and other applicable Federal, State, and local laws and regulations. In the proposed and final rule at § 418.64(d), we require that counseling services, including bereavement counseling, are provided by or under the supervision of a qualified individual with experience in grief or loss counseling. Some hospices may use a social worker while other hospices may choose to use chaplains or volunteers to provide this service. This flexibility allows hospices to meet the needs of their patients and families in a manner that works best for their needs and resources. Therefore, we are not prescribing who may or may not furnish bereavement counseling services.
Thus, the revised definition for “bereavement counseling” is as follows: “
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We would like to point out that the term “clinical note” does not limit the notations only to those individuals who are clinicians. Clinical notes may be written by any individual furnishing care and services to a patient, including volunteers, homemakers, vendors, etc. Indeed, we would expect that clinical notes from all individuals would be included in the clinical record because the goal of the clinical note is to include as much information as possible to ensure that all hospice care providers have complete and correct information to use in making care decisions and furnishing care.
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We do not agree that we should prescribe what type of counseling must be provided by a dietitian. We would expect that, based on an assessment of the patient's dietary needs, a hospice would furnish dietary counseling services through an individual whose skills best meet the patient's identified needs. We believe that the needs of the individual patient, rather than preset rules, should be the determining factor relative to services and staff. We do not believe it is appropriate to define the term “dietitian” or establish personnel requirements for dietitians because we believe that hospices should have the flexibility to employ an individual that would meet the needs of their patients in accordance with all other applicable Federal, State, and local laws and regulations.
Additionally, it is not appropriate to require in the definition of the term “employee” that an employee must be trained in issues related to death and dying. We agree that thorough training in issues related to death and dying is necessary for all individuals furnishing patient care services, including clinicians and patient care volunteers. In final § 418.100(g)(1) we now require hospices to educate all hospice employees who have patient contact in the hospice philosophy. Education in the hospice philosophy would, we believe, encompass issues related to death and dying, as the commenter suggested. It is not necessary for office employees with no patient contact to be trained in issues relating to death and dying. To require the training for all employees, regardless of their role within the hospice organization, would unnecessarily burden hospices and divert resources from more critical patient care activities. Therefore, we are not requiring all hospice employees to receive such training.
We believe that clarifying that a multiple location provides the same full array of services as the hospice location originally issued the certification number will alleviate commenter concerns that convenience sites where staff stop in to complete paperwork or check messages, or warehouse sites where equipment is stored would need to be approved by Medicare as multiple locations. We note that although we do not require hospices to obtain approval for warehouse and other single function sites, States may still require hospices to receive approval from State or local authorities. The requirement that multiple locations must share administration, supervision, and services with the hospice that was issued the certification number is relocated from the definition of the term at § 418.3 to the paragraph addressing multiple locations at § 418.100(f)(1)(ii). We continue to believe that it is the level of control and supervision exercised by the hospice that was issued the certification number over the multiple location, rather than mileage limitations or staffing levels, which determines whether or not a site is a multiple location of an existing hospice or a completely separate hospice.
We do not believe that it is appropriate to add specific criteria or procedures for the approval of multiple locations in the regulatory definition because this level of specificity may reduce our ability to adapt to rapid changes in the hospice industry related to the use of multiple locations. Rather, we will continue to address specific criteria and procedures for multiple locations in sub-regulatory guidance such as the State Operations Manual.
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Similarly, narrowing the definition by adding a provision that a drug is not a restraint if it is requested is not appropriate. Requesting a drug does not alter its status as a restraint. In fact, there are times when a patient, representative or family member may request that a drug be administered to protect a patient from his or her own behavior. The requestor would, in essence, be asking for a restraint. Once the drug is administered, the patient would require the increased level of supervision required by this rule in order to ensure the patient's safety and well being at all times. Therefore, we are not adding a provision to exclude drugs from the definition of “drug restraint” if those drugs are requested by the patient or family.
Furthermore, narrowing the definition of “drug restraint” to those drugs that are used inappropriately is not suitable. There are drugs commonly used in the hospice environment for symptom management that can also be used appropriately as drug restraints under limited circumstances when warranted by the patient's condition and needs as documented in the patient's clinical record.
“A drug or medication when it is used as a restraint to manage the patient's behavior or restrict the patient's freedom of movement and is not a standard treatment or dosage for the patient's condition.”
The Children's Health Act (CHA) requires us to promulgate regulations concerning the use of restraints in hospices. Deleting the definition of “physical restraint” would be in conflict with the requirements of the CHA and will not alleviate the concern about the safe and proper use of physical restraints. Indeed, deleting the definition will only leave hospices wondering whether their practices constitute physical restraint and what precautions should be taken to ensure patient safety and well being. We do not believe that this is in the best interest of patients or hospices; therefore we are including a definition to address physical restraints. Moreover, section 591 of the PHS Act sets forth a statutory definition, which is the basis for enforcing regulations on the use of restraints.
At the same time, however, we are sensitive to commenters' concerns that the definition of “physical restraint,” as was proposed, could include bedrails and positional devices. Bedrails and positional devices may have the effect of restraining one patient but not another, depending on the individual patient's condition and circumstances. For example, a partial bedrail may assist one patient to enter and exit the bed independently while acting as a restraint for another patient. Patients who attempt to exit a bed through, between, over, or around bedrails are at risk of injury or death. The potential for serious injury is more likely from a fall from a bed with raised bedrails than from a fall from a bed where bedrails are not used. Bedrails also potentially increase the likelihood that the patient will spend more time in bed and fall when attempting to transfer from the bed. To address these potential hazards, many long term care facilities have replaced the use of bedrails with lower beds, perimeter mattresses, alarms, and sitters for restless individuals. We encourage hospices to have a dialogue with their long term care facility colleagues about the safe and appropriate use of bedrails for hospice patients, as we believe that both parties can learn from their successes. To reflect the fact that it is the function and effect of a device, rather than a device itself, that determines whether or not the device is a physical restraint, we have revised the definition at § 418.3 as follows:
“Restraint means: (a) Any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely, not including devices, such as orthopedically prescribed devices, surgical dressings or bandages, protective helmets, or other methods that involve the physical holding of a patient for the purpose of conducting routine physical examinations or tests, or to protect the patient from falling out of bed, or to permit the patient to participate in activities without the risk of physical harm (this does not include a physical escort).”
This language almost precisely tracks 591(d)(1)(A) of the PHS Act, and matches the definition in the Hospital Conditions of Participation. As a commenter suggested, physical restraint applies to any device that has a restrictive effect, regardless of whether the device is attached to or adjacent to a patient's body. It is the effect of the device, rather than its location, that makes it a restraint. Using the same definition for hospices as is used for other provider types will help ensure that patients are consistently provided the same quality of care and supervision when restraints are used, regardless of whether those patients are in a hospital or a hospice inpatient facility. At the same time, using the same definition will make staff transitions between different provider types easier because the same set of restraint rules will apply to some other provider types. This may be particularly helpful to hospices that have occasion to furnish services under contract where a nurse or other practitioner may be more familiar with the rules governing restraints in hospitals. Having the same definition will help to ensure that there is no conflict between the practitioner's previous background and training and the applicable hospice rules.
Each State establishes its own Medicaid personal care aide benefit, pursuant to our regulations at 42 CFR 440.167, including its own eligibility criteria, scope of services to be provided, and personnel qualifications. Medicaid regulations impose only minimal restrictions on the state's discretion regarding these services. Hospice care is meant to supplement the care provided by the patient's caregiver. If the individual(s) furnishing Medicaid personal care services is functioning as the patient's caregiver, then the hospice would not be expected to replace the Medicaid personal care providers with its own homemaker services on a round-the-clock basis. The Medicare hospice benefit is not meant to be a caregiver benefit and should not be expected to function as such. Hospices should work with their respective State Medicaid agencies if they have questions about who pays for services provided to patients eligible for both Medicare and Medicaid.
With regard to who is qualified to furnish homemaker services on behalf of a hospice, we proposed in § 418.76(j) that a homemaker must have either completed home health aide training requirements or must have successfully completed a hospice's orientation addressing the needs and concerns of patients and families coping with a terminal illness. We continue to believe that either home health aide (now referred to as a hospice aide) training or hospice orientation provides sufficient knowledge for an individual to function as a homemaker under the supervision of the IDG, and our final requirements at § 418.76(j) and § 418.76(k) reflect this.
It is important to point out that if we had included delegated services in the definition of the term “nursing services,” then the inclusion would effectively prohibit hospices from contracting for hospice aide services. We believe that this de facto prohibition would occur because those contracted hospice aides would routinely be furnishing delegated nursing services, and section 1861(dd) of the Act requires that substantially all nursing services should be furnished by direct hospice employees. We do not think that the commenters intended to establish this de facto prohibition on contracting for hospice aide services.
We proposed to replace the existing CoP, Informed consent, at § 418.62, with a new patient rights CoP. The proposed patient rights CoP was divided into five standards. The first standard, “(a) Notice of rights,” would have required hospices to develop a notice of rights, including information about advance directives and the hospice's controlled
In standard (b), “Exercise of rights and respect for property and person,” we proposed that the patient would be able to exercise his or her rights, be respected, voice grievances, and not be subjected to discrimination or reprisal. We also proposed that hospices would investigate and report all alleged violations of patient rights, and take appropriate corrective action where necessary.
The third standard, “(c) Pain management and symptom control,” proposed that patients would have the right to receive effective pain management and symptom control from the hospice.
Standard (d), “Confidentiality of clinical records,” proposed that hospices would be required to maintain the confidentiality of clinical records in accordance with the Privacy Rule published in the
Finally, the fifth standard, “(e) Patient liability,” proposed that patients would be informed about the extent to which payment may be expected from the patient, Medicare or Medicaid, third-party payers, or other sources, verbally and in writing in a language that the patient was able to understand. This standard proposed that this information would be provided to patients before care was furnished. The intent of this standard was to ensure that patients were aware of their potential out-of-pocket costs for hospice care, such as co-payments, so that they would not be surprised by financial concerns at this stressful time.
Even so, we are sensitive to the concerns of hospice providers. The HHS guidance on Title VI (August 8, 2003, 68 FR 47311) applies to those entities that receive federal financial assistance from HHS, including hospices. This guidance presents four areas for hospices to consider when developing and implementing strategies to meet the needs of limited English proficient persons. The guidance recognizes the role of professional translation services, as well as family and friends of the patient, in communicating important information to patients, including the notice of rights. Hospices are already expected to comply with the HHS guidance, and doing so will enable them to comply with the requirements of the proposed rule.
Using family and friends as translators should not be the communication plan of choice for the hospice for its patients who do not speak English, unless the patient specifically requests this approach. Hospices should make all reasonable efforts to secure a professional, objective translator for hospice-patient communications, including those involving the notice of patient rights. Furthermore, hospices should make all reasonable efforts to have written copies of the notice of rights available in the language(s) that are commonly spoken in the hospice's service area. For those patients who speak uncommon languages in areas where professional translators for those languages are not readily available, using family and friends of the patient is an acceptable option.
However, we agree that further clarifications are warranted to ensure that a hospice assumes full responsibility for its staff, while not overwhelming the hospice with responsibilities beyond its control. To that end, we are requiring hospice staff that discover alleged violations to immediately report such allegations involving anyone furnishing services on behalf of the hospice, including contracted and arranged services, to the hospice's administrator. The hospice administrator must investigate violations involving anyone furnishing services on behalf of the hospice and, if verified, the hospice must report the violation to State and local bodies having jurisdiction within 5 working days of any member of the hospice staff (including those furnishing contracted or arranged services) becoming aware of the violation in accordance with the hospice's own policies and procedures. We would expect that significant violations, such as illegal actions by hospice staff, would be reported to State and local bodies. We believe that these modifications will ensure that violations are fully addressed while not overburdening hospices.
This requirement will assure that the SNF/NF or ICF/MR is made aware of the alleged violation in a timely manner so that it can begin its own investigation and implement its own intervention(s). A hospice may also want to consider incorporating a provision in the contract to require a SNF/NF or ICF/MR to notify the hospice if any of its staff become aware of a potential patient rights violation involving hospice staff. Such a provision may enhance hospice-facility communication and cooperation. In addition, we will consider this issue when developing complementary regulations for long term care facilities.
The presence of the term “injury” is also important in this standard because it addresses other issues that may not constitute “abuse” or “neglect” but that nonetheless impact a patient's well-being. We understand that some relatively minor injuries such as skin tears may be perceived as injuries. By maintaining the term “injury” in this standard, hospices are required to fully investigate incidents of minor injuries (like skin tears) to determine if they constitute a violation of a patient's rights. If the internal investigation reveals that all appropriate steps were taken to prevent the minor injury, then the hospice may determine that the injury is not a violation of a patient's rights. However, if the investigation reveals that reasonable precautions were not taken, then the hospice may determine that the injury is a violation of patient rights. In setting forth a standard in the final rule that requires hospices to report patient injuries to the hospice administrator, hospices have the opportunity to conduct a self assessment to determine if care processes need to be changed to improve the consistent delivery of quality care.
It is acceptable for hospices to refer pain and symptom control issues unrelated to the terminal illness and related conditions to other providers. If a hospice were to make a referral, we would expect the hospice to coordinate its efforts with the other provider to avoid duplicative or contradictory therapies in accordance with final § 418.56(e)(5). The goal of this coordination is to ensure that the patient's hospice plan of care is implemented, and that the hospice care is furnished in concert with other care sources to ensure that all patient needs are met. In accordance with § 418.100(c) hospices are responsible for pain and symptom management related to the terminal illness and related conditions and should not refer patients to other providers for these issues. If a hospice does not have the expertise to handle pain and symptom management issues related to the terminal and related conditions, it is responsible for procuring the expertise for the patient as part of its regular hospice services.
We also agree that providing a patient with general information about the scope of services that the hospice provides, as well as any limitations on those services, will further empower hospice patients and their caregivers to take an active role in hospice care planning. Providing the patient and family a list of services that the hospice may provide gives the patient and family an opportunity to request specific services that the IDG had not considered. Simply knowing that help is available may lead patients and families to reach out for it. For this reason, we are establishing section § 418.52(c)(8), which requires hospices to provide information about the scope of services that the hospice will provide to its patients, and specific limitations on those services.
The proposed assessment requirement identified the general areas that would be included in a patient assessment and the timeframes for completing the assessments to help hospices ensure that they were identifying needs in all areas in a timely fashion.
The proposed comprehensive assessment requirement was divided into five standards. The first standard, (a), “Initial assessment,” would require a registered nurse to make an initial assessment visit within 24 hours of receiving a physician's admission order for care, unless ordered otherwise by the physician. The purpose of this initial assessment was to determine the patient's immediate care and support needs. In the proposed rule we differentiated this initial assessment from the hospice's evaluation of a patient's appropriateness for hospice care. We stated that visiting a patient to determine his or her appropriateness for hospice care does not constitute an initial assessment.
The second standard, (b), “Timeframe for the completion of the comprehensive assessment,” proposed that the hospice IDG and the patient's attending physician complete the comprehensive assessment no later than four calendar days after the patient elected the hospice benefit. The four day timeframe was proposed because many hospice patients are admitted to hospice late in their terminal illness and often require intensive hospice services at the beginning of their hospice stay. A hospice must assess a patient to identify his or her needs before it can develop and implement a plan of care to meet those needs. Therefore, a timely assessment is necessary to properly care for a patient.
In the third standard, (c), “Content of the comprehensive assessment,” we proposed that hospices identify the physical, psychosocial, emotional, and spiritual needs of the patient related to the terminal illness and related conditions. As proposed, the comprehensive assessment would include information about the terminal condition, complications and risk factors, an initial bereavement assessment, a drug profile review, and any further referrals or evaluations, as appropriate. We did not propose that hospices use a specific assessment form or tool.
Under proposed standard (d), “Update of the comprehensive assessment,” the hospice IDG would be required to update each patient's comprehensive assessment no less frequently than every 14 days and at the time of each recertification. The proposed comprehensive assessment update would document changes that had occurred since the last assessment, including the patient's progress toward desired outcomes and the patient's response to the care furnished by the hospice. We proposed these update timeframes because the condition of a hospice patient is expected to change over the course of hospice care, and often does so quite rapidly, considering that the median length of a hospice stay is about 26 days.
The final standard in this proposed CoP, (e), “Patient outcome measures,” would require hospices to include, as part of the information gathered by the comprehensive assessment, data elements to allow hospices to measure patient outcomes. This standard proposed that the data elements would be collected and documented in the same manner for all patients in order to ensure the accuracy and consistency of the data. Hospices would be required to use the data in individual care planning and the quality assessment and performance improvement program described in proposed § 418.58. We did not propose to require hospices to use any specific patient outcome measures or data elements.
Modifying the requirement does not mean that hospices are prohibited from identifying and/or addressing issues and areas of patient need outside of the hospice benefit, even though hospices are not responsible for providing services for these issues. Indeed, not gathering the information may make it more difficult for hospices to effectively plan to care for a patient because important information would not be available when making care planning decisions.
In order to clarify the length of time that hospices have to complete the initial assessment, we have referenced language used in Subpart B, Eligibility, election and duration of benefits, of the existing hospice regulations, into the initial assessment requirement at § 418.54(a). Once a hospice has obtained an election statement for a particular Medicare or Medicaid patient in accordance with the requirements of Subpart B, the hospice has 48 hours to complete the initial assessment, unless the patient, his/her representative, and/or physician request an expedited timeframe. Since election requirement is particular to the Medicare and Medicaid hospice benefits, hospices are free to establish a similar starting point for non-Medicare and Medicaid patients in their own policies, based on the needs of the hospice, its community, and any applicable State and local laws and regulations.
We also agree that the needs of patients or their representatives should be taken into consideration when completing the initial assessment. There are times when patients or representatives may want to expedite the initial assessment, and their wishes, along with the health status of the patient, should be taken into account when scheduling and completing the initial assessment. For example, a patient's representative may request that the hospice complete the initial assessment in a shortened timeframe because the patient is in acute distress and requires immediate hospice assistance. We would expect the hospice to consider the patient's or representative's request for a change in the initial assessment timeframe when scheduling the necessary visit(s) to complete the initial assessment. Therefore, we have modified the language to state that the patient or representative may request that the initial assessment be completed in less than 48 hours.
If a patient or representative wishes to delay the completion of the initial assessment, it would not be appropriate to have that patient or representative elect the hospice benefit. When a patient elects the hospice benefit she waives the right to receive all other Medicare covered services for the terminal illness and related conditions. If the patient may not receive all other Medicare covered services for the terminal illness and related conditions, and that patient cannot receive hospice services because she has not received an initial assessment to determine her immediate care needs, then the terminally ill patient is effectively without health care for the intervening time period. We do not believe that this is an acceptable situation.
Standard (a), “Initial assessment,” now states, “The hospice registered nurse must complete an initial assessment within 48 hours after the election of hospice care in accordance with § 418.24 is complete (unless the physician, patient, or representative requests that the initial assessment be completed in less than 48 hours).”
It is not appropriate to substitute an initial contact for an initial assessment. Merely requiring an initial contact within 24 hours would not be sufficient to meet the needs of critical patients. Patients often come to hospice in moments of crisis. An initial contact when a patient is in need of timely assistance would be a disservice to the patient and family and would not lead to effective, high quality care. Hospices may choose to send a social worker or other discipline to complete the initial assessment along with the RN, and this may lead to better patient outcomes and satisfaction. Because other disciplines do not have the skills necessary to independently complete the initial assessment, we are not incorporating the commenters' suggestions.
Overall, many commenters stated that the 24 hour timeframe for the initial assessment, as we proposed, was too restrictive. In this final rule we have effectively increased the length of the timeframe by changing its starting point from the time the physician's order is received to the time that the election statement is complete in accordance with the applicable requirement of Subpart B. Under the proposed rule, hospices would have been required to complete the initial assessment within 24 hours of the physician's order to begin hospice care, even if the hospice was unable to schedule a visit with the patient and family within that timeframe. Under the revised final rule language, hospices have 48 hours after the patient elects the hospice benefit to complete the initial assessment. At times, a patient, representative, or physician may request that the comprehensive assessment be completed in a timeframe less than 48 hours, and we expect hospices to accommodate such requests when they are made.
At the same time, we are sensitive to the concerns expressed by the hospices. Some patients do not have attending physicians. Some patients do not want to continue seeing their attending physicians. Some attending physicians may be unresponsive to, or uncooperative with, the hospice. We do not want to place patients in a position where they must choose between receiving services from their attending physician and their hospice, nor do we want to place hospices in a position where they are forced to handle difficult attending physicians who disrupt their operations.
In light of these considerations, we are maintaining the requirement that hospices consult with the patient's attending physician when completing the comprehensive assessment. Involving the attending physician to the extent possible will allow hospices to gain additional information about the patient. Attending physicians can often provide a lengthy history of the patient's disease process and family dynamics can help the hospice make better care planning decisions that result in improved patient outcomes. In recognition of the fact that not all patients have willing attending physicians, we have added a caveat that this consultation need only occur if there is an attending physician to consult with. In this way, attending physicians may, with the patient's agreement, opt out of following the patient's care through the patient's hospice stay. We are not, as some commenters suggested, requiring that the attending physician sign a document approving the content of the comprehensive assessment. Rather, we leave it to hospices to define in their own policies and procedures how they will document that they have conferred with the attending physician. We believe that this will give hospices the ability to structure their communication and coordination system in a way that meets their needs for timely information sharing and documentation.
In the middle are the commenters who suggested maintaining the four-day requirement, lengthening it to five days, or lengthening it to seven days. While we appreciate the support from commenters who agreed with the proposed four-day timeframe, we agree with those commenters who suggested that a longer timeframe would be more appropriate due to the scheduling demands of hospice providers. We have lengthened the timeframe from four days to five days. Allowing hospices another day to complete the comprehensive assessment will allow more time to schedule the necessary contacts.
While we have lengthened the timeframe, we note that it is a maximum, a length of time that should not be exceeded. The timeframe should not be misinterpreted to prevent hospices from completing the comprehensive assessment earlier than five days after the patient or representative elects the hospice benefit. Indeed, we encourage hospices to complete comprehensive assessments in less than five days if at all possible. This is particularly true for patients who enter hospice in crisis. While the initial assessment will provide the necessary information to begin the plan of care for these critical patients, it is the comprehensive assessment that will fill in important pieces of information to be used to maximize the patient and family's physical, emotional and spiritual comfort. While we recognize that a portion of patients enter hospice at the end stage of the disease process and may die in less than five days after electing the hospice benefit, their physical condition does not necessarily absolve hospices of the responsibility to comprehensively assess these patients. The hospice is still responsible for taking all appropriate steps to complete the comprehensive assessment as that assessment is tailored to the patient's areas of need. The ability of hospices to tailor the exact content of the comprehensive assessment, and the individuals who complete it, to the needs of patient and families addresses concerns about extremely short stay patients who may not be contacted by all disciplines before death. We do not expect or require designated disciplines to complete assessments if those assessments are not indicated as being necessary during the initial assessment and any subsequent contacts.
Medications that are unnecessary or are not consistent with patient therapy goals; Medications requiring dosage optimization; Medications that are inappropriate according to evidence based guidelines; and Missing medications that are necessary to prevent or address symptoms experienced by the patient.
We also appreciate the suggestions to help clarify the role of the bereavement assessment within the comprehensive assessment. We agree that the information gained in the initial bereavement assessment should be incorporated into the hospice plan of care. Issues identified in the initial bereavement assessment such as anticipatory grief and previous experiences with loss should inform care planning decisions long before the patient dies. By requiring hospices to incorporate bereavement assessment information into the plan of care, hospices will be able to develop a more complete picture of the patient and family.
Likewise, we agree that feelings can change over time, rendering the information gathered in the initial bereavement assessment moot at the time of the patient's death. For this reason, we are no longer requiring that information gathered from the initial bereavement assessment be incorporated into the bereavement plan of care. Rather, we are requiring that the information from the initial bereavement assessment be considered in the bereavement plan of care. This change still requires hospices to begin the bereavement assessment process early in the patient's stay. However, the change reflects that fact that the bereavement assessment will change as it is updated. Furthermore, the change allows hospices to use the most accurate bereavement assessment information, regardless of when it was obtained, in developing the bereavement plan of care.
The active involvement can occur in any number of ways depending on the patient's needs and preferences. Some families may need a face-to-face visit from a social worker to help them sort through myriad insurance papers or simply provide a supportive presence, while other families may find it easier to discuss difficult issues by phone. If families need or prefer in person visits, then those needs should be met. If they prefer the limited anonymity afforded by the telephone, then their preference should be accommodated. We cannot provide the clear cut answer that commenters are seeking because each patient, family, and situation is different. Decisions about who assesses and how they assess need to be based on the needs of the patient and family and the hospice's own policies and procedures.
We also appreciate the many timeframe suggestions that we received. We agree that the proposed 14-day timeframe, while within reason and in the realm of acceptable standards of practice, may not be the best match between patient and hospice needs. Numerous commenters suggested that updating the comprehensive assessment at least every 15 days was the proper match, as the 15-day timeframe would correspond with the 60- and 90-day Medicare Hospice Benefit election periods described in § 418.21. Corresponding the update timeframe length to the benefit period length would help hospices avoid completing separate assessments for the routine comprehensive assessment update and the update to re-certify that the patient is terminally ill. Two separate assessments within a few days of each other would be overwhelming for the patient and burdensome for the hospice. Thus, we agree that requiring hospices to update the comprehensive assessment at least every 15 days is preferable to the proposed 14-day timeframe. We believe that the new 15-day timeframe accomplishes the flexibility goals of those commenters who suggested twice monthly, bi-weekly, and every 14- to 16-day updates as well. We note that hospices are still required to complete the comprehensive assessment update more frequently than every 15 days as the patient's status changes. We also note that hospices are permitted to update the assessment more frequently than every 15 days if the 15th day falls on a holiday or if day-to-day hospice operations are scheduled to be suspended for any reason on the 15th day.
At the same time, we do not expect hospices to limit their QAPI-related data collection efforts to the data collected in the patient assessments. Data collection must look beyond patient assessment data to examine all facets of a hospices operation, from contract services to volunteer retention rates to adverse events. Rather than limiting the amount of useful data available to hospices, this requirement simply ensures that patient level data are included as part of the broader data collection program.
For additional discussion of public comments regarding patient outcome measures and the proposed QAPI CoP, please refer to the quality assessment and performance improvement section in the preamble of this rule.
Next, the hospice must complete a comprehensive assessment within five days of completion of the election statement. The comprehensive assessment is defined as a thorough evaluation of the patient's physical, psychosocial, emotional and spiritual status related to the terminal illness and related conditions. This includes a thorough evaluation of the caregiver's and family's willingness and ability to care for the patient. This comprehensive assessment is based on the hospice's policies and procedures as well as the information gathered in the initial assessment. For example, a hospice may have a policy that all patients will receive a psychosocial assessment conducted by an MSW. Therefore, we would expect that a patient's comprehensive assessment in his or her clinical record would include the information gathered by and the conclusions made by an MSW. The comprehensive assessment requirement is flexible to adapt to the needs of individual hospices and patients, and will help hospices gather the information needed to develop accurate and appropriate plans of care.
Then, based on the information gathered in the comprehensive assessment, the hospice IDG, in collaboration with the patient's attending physician (if any), the patient or representative, and the primary caregiver, must develop an individualized plan of care for each patient. The plan of care must reflect patient and family goals, and include all interventions needed to address the problems identified in the initial and comprehensive assessments. The plan of care is where information turns into
Once the plan of care is established and all disciplines are aware of their respective roles in caring for the patient, the hospice must implement the plan of care. If the patient's status in one or more areas changes, hospice staff must update the comprehensive assessment to reflect the change(s). We do not expect hospices to complete an entire comprehensive assessment each time a patient's status changes. Rather, we expect that the updated assessment reflects status changes so that other disciplines furnishing services are aware of them. Updating the comprehensive assessment will ensure that all disciplines are providing care based on the most recent information about the patient. We require that these updates occur as frequently as that patient's condition requires, but no less frequently than every 15 days. If a change in the patient's status will affect the kind of care that needs to be furnished, then the plan of care needs to be modified. For example, information from a comprehensive assessment could indicate that a patient has a stage three pressure ulcer and the patient's plan of care indicates that the hospice registered nurse will make three visits a week, in part, for wound care. The wound care provided by the registered nurse results in the pressure ulcer healing. This change in status would be recorded as an update to the comprehensive assessment. Based on this new information in the updated comprehensive assessment, the hospice IDG may decide to reduce registered nursing visits to two times per week because the patient's status and needs no longer indicated that RN visits three times per week were necessary. The hospice IDG would then update the patient's plan of care to reflect that RN visits will be two times per week and that wound care was no longer part of the treatment that the RN would provide. In this way, the patient's assessment and plan of care are both updated to provide accurate and timely information to all disciplines providing services to the patient, and the hospice complies with our requirements to update both the comprehensive assessment and the plan of care.
We believe that the timeline described above will help illuminate the timeframe requirements for both the assessment and plan of care requirements, as well as how these two requirements are related.
Hospices may find it beneficial to examine the CARE (Continuity Assessment Record and Evaluation) tool developed by CMS in choosing their assessment forms/tools. Under the Deficit Reduction Act of 2005, Section 5008, CMS was directed to develop a uniform patient assessment instrument for use in a three year, post acute care-payment reform demonstration, to begin in January 2008. This uniform assessment instrument is now referred to as CARE. The purpose of the CARE tool is to collect standardized data on Medicare beneficiaries' medical conditions, functional and cognitive impairments, and social support factors, affecting treatment and discharge, regardless of site of care. During the demonstration CARE will be administered to Medicare beneficiaries at time of hospital discharge, upon admission and discharge from post acute care (PAC) providers, as well as at interim points, if significant changes occur. CARE is comprised of a set of common assessment items administered to all patients across all settings, and a set of supplemental items only administered for specific conditions or at particular times (
If, at some time in the future, we determine that it is necessary to require hospices to use a standardized patient assessment tool, we will follow the provisions of the Administrative Procedure Act, which generally requires us to publish a notice of proposed rule making and solicit public comment on the proposal.
This proposed CoP elaborated on the existing Interdisciplinary group CoP at § 418.68 and combined it with elements of the Plan of care CoP at § 418.58. It contained five standards: “(a) Approach to service delivery,” “(b) Plan of care,” “(c) Content of the plan of care,” “(d) Review of the plan of care,” and “(e) Coordination of services.” Together, these standards would have required a hospice, through its IDG, to develop, implement, and update a comprehensive plan of care for each patient and family that addresses their needs as identified in the patient assessment.
Standard (a), “Approach to service delivery,” would require each hospice to have an IDG that included at least the following: A doctor of medicine or osteopathy who is not the patient's attending physician; a registered nurse; a social worker; and a pastoral, clergy, or other spiritual counselor. This IDG would be required to work together to meet the physical, medical, social, emotional, and spiritual needs of the patient and family. The IDG would also be required to designate a qualified individual to coordinate implementation of the plan of care and assessment of the patient. Paragraph 418.68(d) of the existing rule required the IDG to designate a registered nurse to fulfill this role. In the proposed rule, the IDG would be required to establish policies governing the day-to-day provision of care and services. If a hospice has more than one IDG, one
The next proposed standard, “(b) Plan of care,” would require hospices to provide care to patients and families in accordance with a written plan of care established by the IDG and the patient's attending physician. This standard would also require hospices to ensure that patients and families received appropriate education and training that would enhance the implementation of the plan of care. Unlike the existing requirement, this proposed standard would incorporate families into the plan of care, recognizing that hospice care must reach beyond the patient to support those who surround and care for the patient.
In proposed standard (c), “Content of the plan of care,” we would require hospices to develop a plan of care based on the problems identified in the patient's assessments. We proposed to require that the plan of care include: Pain and symptom management interventions; a detailed statement of the scope and frequency of services; patient outcomes; any necessary drugs and treatments; any necessary medical supplies and equipment; and documentation of the patient's and family's understanding, involvement, and agreement with the plan of care. The existing plan of care requirement at § 418.58(c) mandated that the hospice describe the scope and frequency of services. The remainder of the elements were new in the proposed rule.
The fourth proposed standard, “(d) Review of the plan of care,” would require the hospice medical director or physician designee, along with the IDG and the patient's attending physician, to review, revise, and document the plan of care at intervals specified in the plan of care. The review of the plan of care would be required to occur no less frequently than every 14 calendar days. The revised plan of care would be required to include information from the patient's updated assessment, and the hospice would have to document any progress toward the outcomes specified in the plan of care. This proposed requirement directly linked the results of the updated assessment, including the data elements, to the changes that would be made in the plan of care. This would empower hospices to make care decisions based on evidence of the successes and failures of past care decisions in achieving the desired outcomes.
The final proposed standard, “(e) Coordination of services,” was a new addition to the hospice CoPs. Hospice has always been based on an interdisciplinary care model, which requires frequent communication between care disciplines and settings, as well as between the hospice, the patient and the family. This proposed standard would require the hospice to maintain a system of communication and integration to enable the IDG to ensure that care and services are provided in accordance with the plan of care. This system would also be required to ensure the ongoing liaison of all disciplines providing care and services in the home, outpatient, and inpatient settings, notwithstanding the manner in which the care and services are furnished (that is, directly or under arrangement).
The majority of commenters noted the unique demands of the case coordinator role and the many skills that are necessary to successfully fulfill the role. Commenters described the need for the case coordinator to have solid knowledge of the biological, psychological and spiritual issues of terminally ill patients and their families. They also described the need for the case coordinator to act as an advocate, negotiator, and leader when dealing with the varied members of the IDG, the patient, and the patient's family. We agree that the specific demands of the case coordinator role, as described by the commenters, warrant a more specific requirement regarding who is qualified to fulfill this role. Therefore, we are requiring the coordinator to be a registered nurse. A registered nurse has the necessary medical and interpersonal background to meet the demands of the coordinator position in a way that no other discipline does. Social workers are not educated or trained to identify physical issues, just as physical or occupational therapists are not educated or trained to identify psychosocial issues. The unique skills of registered nurses, who are educated to assess and manage the overall aspects of a patient's physical and psychosocial care, can be used to oversee the coordination and implementation of the care identified by the IDG.
Nothing in this requirement prohibits hospices from using certified chaplains as the IDG member to fulfill this role. Indeed, some hospice patients who receive the services of certified chaplains may have better outcomes because certified chaplains are trained to work with individuals from various faiths and backgrounds.
If a hospice does not choose to furnish services for those needs unrelated to the terminal illness and related conditions, we would expect the hospice to communicate and coordinate with those health care providers who are caring for the unrelated needs, as described in § 418.56(e). In such situations where a hospice coordinates its care and services for the terminal illness and related conditions with care and services provided by other health care providers for unrelated conditions, we believe that it is essential for the hospice to be aware of their role within the larger comprehensive plan of care for that patient. Furthermore, we believe that it is essential for the hospice to be aware of any gaps in the overall comprehensive plan of care, and the parties responsible for filling those gaps.
We did not, as the other commenter suggested, replace “measurable outcomes” with “agreed-upon goals.” Instead, we have added a statement to § 418.56(c) to state that, “[t]he plan of care must reflect patient and family goals and interventions based on the problems identified.* * * ” We believe that this is an appropriate way to include patient and family goals in the plan of care without excluding measurable outcomes, which are part of the individual patient care planning process and the hospice's overall QAPI program. We expect the hospice plan of care to address all patient goals in some way. If a patient has a goal that is not related to the terminal illness and related conditions, and if the hospice does not intend to address this goal, then the hospice plan of care should identify the party that is responsible for meeting the unrelated goal. Furthermore, final § 418.56(e) requires the hospice to actively communicate with the outside party to ensure that the goal is addressed.
Furthermore, we agree that, rather than requiring hospices to document complete understanding, involvement and agreement with the plan of care, it is more appropriate to require hospices to document the level of understanding, involvement and agreement attained by the patient or representative. The terminal illness and numerous other factors may affect a patient's or representative's ability to participate in care planning or understand the content of the plan of care. Requiring hospices to document a level of understanding, involvement and agreement with the plan of care recognizes this fact. Hospices will now be required to note whether impediments to understanding are present and the degree to which those impediments impact the patient's or representative's participation in care planning. Documenting this information will help hospices tailor the content of the plan of care and their patient communication process to the needs of the patient, resulting in improved patient outcomes.
The exact structure of the system of communication and integration will vary depending on the unique needs of each hospice. Telephone, e-mail, instant messaging, the postal service, and any other form of communication may be used in accordance with a hospice's own policies and procedures. Likewise, clinical notes, IDG meeting minutes, and any other form of documentation associated with the patient's plan of care may be used to demonstrate compliance with this requirement, in accordance with a hospice's own policies and procedures. We believe that allowing hospices to determine the structure of the system and the documentation necessary to ensure that the system is used in the best and most flexible method for ensuring that hospices are able to comply with this provision.
The existing § 418.66, “Condition of participation-Quality assurance,” relies on a problem-oriented approach to identify and resolve patient care issues. Failure to meet the quality assurance condition is consistently one of the top 10 deficiencies cited by Medicare surveyors nationwide. During the last decade the health care industry, including the hospice industry, has moved beyond the problem-oriented, after-the-fact corrective approach of quality assurance to an approach that focuses on a preemptive plan that continuously addresses QAPI. Hospice industry associations have indicated that the upgraded QAPI approach used by many hospice providers is incompatible with the existing quality assurance condition. On the other end of the spectrum some providers do not have any quality program.
The proposed QAPI requirement would raise the performance expectations for hospices seeking entrance into the Medicare and Medicaid programs, as well the expectations of those currently participating in Medicare and Medicaid. We proposed that each hospice would develop, implement, and maintain an effective, continuous quality assessment and performance improvement program that stimulates the hospice to constantly monitor and improve its own performance, and to be responsive to the needs, desires, and satisfaction levels of the patients and families it serves. The desired overall outcome of this proposed CoP would be that the hospice would drive its own quality improvement activities and improve its provision of services. With an effective quality assessment and performance improvement program in place and operating properly, a hospice can better identify and reinforce the activities it is doing well, identify its activities that are leading to poor patient outcomes, and take actions to improve performance. A hospice would be free to develop a program that meets its needs. As proposed, a provider's QAPI program would not be judged against a specific model.
The proposed QAPI CoP was divided into five standards. Under standard § 418.58(a), “Program scope,” a hospice's quality assessment and performance improvement program would include, but not be limited to, an ongoing program that would be able to show measurable improvement in indicators that were linked to improving palliative outcomes and end-of-life support services. We expect that a hospice would use standards of care and the findings made available in current literature to select indicators to monitor its program. The hospice would measure, analyze, and track these quality indicators, including areas such as adverse patient events and other aspects of performance that assess processes of care, hospice services, and operations. (“Adverse patient events,” as used in the field, generally refer to occurrences that are harmful or contrary to the targeted patient outcomes.)
The second proposed standard at § 418.58(b), “Program data,” would require the hospice program to incorporate quality indicator data, including patient care, administrative, and other relevant data, into its QAPI program. This would include data that were received from or submitted to hospice professional organizations. We did not propose to require that hospices use any particular process or outcome measures. However, a hospice that would choose to use the available quality measures would be able to expect an enhanced degree of insight into the quality of its services and patient satisfaction, compared to beginning the outcome-measure development process anew because currently existing measures have already been tested to some degree for reliability and validity.
Proposed standard (b) also would require that data collected by the hospice, regardless of the source of the data elements, would be collected in accordance with the detail and frequency specifications established by the hospice's governing body. Once collected, hospices would use the data to monitor the effectiveness and safety of services, and to identify opportunities for improvement.
The third standard under the quality assessment and performance improvement program at proposed § 418.58(c), “Program activities,” stated that the hospice would set priorities for its performance improvement activities that focused on high risk, high volume and problem-prone areas, considered the prevalence and severity of identified problems' and gave priority to improvement activities that affected palliative care, patient safety, and quality of care outcomes. In § 418.58(c) we also proposed to require the hospice to track adverse patient events, analyze their causes, and implement preventive actions that would include feedback and learning throughout the hospice.
We proposed at § 418.58(d), “Performance improvement projects,” that the number and scope of improvement projects conducted annually would reflect the scope, complexity, and past performance of the hospice's services and operations. The hospice would document what improvement projects were being conducted, the reasons for conducting them, and the measurable progress achieved on them.
In the final proposed standard at § 418.58(e), “Executive responsibilities,” a hospice's governing body would be responsible and accountable for ensuring that the ongoing quality improvement program was defined, implemented, and maintained. The governing body would ensure that the program addressed priorities for improved quality of care and patient safety. The governing body would also specify the frequency and detail of the data collection and ensure that all quality improvement actions were evaluated for effectiveness. The governing body's most important role would be to ensure that staff were furnishing, and patients were receiving, safe, effective, quality care. Therefore, it would be incumbent on the governing body to lend its full support to agency quality assessment and performance improvement efforts.
We believe that it is essential to a hospice's QAPI program to begin tracking and analyzing adverse events at the same time that it begins collecting patient level outcome measure data elements and hospice-wide measures. Since adverse events generally result in harm to a patient, they serve as important indicators of areas for potential improvement. If hospices do not collect adverse event information, they may be missing important data from which to assess their performance. Therefore, we are not delaying the adverse event requirements in this final rule.
We require in § 418.104(a)(4) that the patient care outcome measure data be included in the patient's clinical record because hospices must use such data for individual care planning and coordination of services (§ 418.54(e)(2)). Hospices are free to document the patient care measure data in other locations as well in order to meet their needs. All documentation must be in accordance with the data collection policies and procedures established by the hospice to ensure consistency and retrievability.
In addition, the National Hospice and Palliative Care Organization launched a National Quality Initiative and Quality Collaborative to improve hospice and palliative care outcomes. This initiative is helping hospices develop functional
Furthermore, the National Quality Forum has issued voluntary consensus standards for end-of-life care of cancer patients, who comprise approximately 50 percent of the hospice patient population (
The National Quality Forum also issued the “National Framework and Preferred Practices for Palliative and Hospice Care Quality” (2006,
Furthermore, the agency for Healthcare Quality and Research (AHRQ) issued an evidence-based review of end-of-life care and outcomes (
We believe that these efforts, combined with the measures already identified by the NHPCO and Brown University (Time Toolkit,
We do not believe that these efforts are sufficient to establish nationwide benchmarks that are appropriate for inclusion in this rule. More time is needed to test, refine, and collect further data related to any specific measure before we could establish a nationwide benchmark that all hospices should be required to meet. The necessary information is simply not available at this time to establish mandatory benchmarks, although hospices are free to use existing benchmarks to measure their own performance against that of other similar hospices who use the same measures.
In order to further the process of establishing widely-accepted, valid, benchmarked quality measures, CMS is actively pursuing additional research on selected quality measures. This research will help identify and refine measures that are valid, meaningful, and reliable for hospices. It will also help establish benchmarks for hospices to attain.
Following publication of this final rule, CMS will issue further sub-regulatory guidance on QAPI.
When analyzing data on a patient level, sample size does not matter. To use the patient outcome measure of pain controlled within 48 hours of admission discussed above in the patient assessment section, a hospice would need to document for a patient the presence or absence of uncontrolled pain upon the patient's admission to hospice. If a patient has uncontrolled pain, the hospice would then reassess his or her pain 48 hours after the patient's admission to hospice and document the presence or absence of uncontrolled pain at that time. This does not mean that the hospice does not assess the patient's pain between the initial pain assessment and the 48 hour pain assessment. Indeed, the hospice may need to assess the patient's pain far more frequently in order to adjust the treatments being provided to control the patient's pain. In completing a patient-level analysis of the patient's data, the hospice would be able to judge the effectiveness of the initial care furnished in controlling the patient's pain.
In completing the hospice-wide analysis, this patient's pain control data would be aggregated with the pain control data of the other patients that the hospice cared for. This aggregated data would allow the hospice to look for patterns such as a high level of pain control success for patients with cancer diagnoses and lesser levels of success for congestive heart failure patients. Identifying patterns, areas of strength, and areas of weakness allows the hospice to reaffirm promising practices that lead to positive patient outcomes and re-examine practices that lead to inadequate or negative patient outcomes.
Aggregation of data must be done in accordance with the policies and procedures established by the hospice. If a hospice has an extremely small average monthly census, then it may make sense for that hospice to aggregate several months of data. Likewise, if a hospice has an extremely large average monthly census, then it may make sense for them to aggregate the data more frequently to ensure that the amount of data does not become overwhelming to those analyzing it. The flexible nature of the patient outcome measure standard and the quality assessment and performance improvement CoP allow hospices to adapt data collection and analysis to their needs and goals.
We believe that our governing body requirements meet the intent of the Joint Commission leadership standards. Therefore we are setting forth this requirement as final. The governing body may assume hands-on control of the QAPI program to ensure that the program is in compliance with this rule, or it may choose to appoint one or more individuals to handle the structure and administration of the QAPI program while the governing body retains ultimate responsibility for the actions of the designated individual(s).
As many commenters noted, the individuals who compose the governing body may not have significant experience in a hospice QAPI program and would therefore not be the best candidates to actively supervise or direct its activities. For this reason, it may not be appropriate to require the governing body to actively monitor the QAPI program if this function can be managed by others more knowledgeable in clinical and/or related fields of endeavor. A new provision has been added at § 418.58(e)(3) explicitly requiring the governing body to appoint QAPI leaders.
In addition to this completed project, CMS plans to sponsor additional research that will examine the validity, reliability, appropriateness, and usefulness of select quality measures. Furthermore, CMS plans to sponsor work that will develop a method for QIOs to actively assist interested hospices in developing and implementing QAPI programs.
At the same time, we are sensitive to the concerns of hospice providers who are wary of the new and unknown. As described above, we conducted a special study through the Carolina QIO to identify hospice measures focusing on the quality of clinical care furnished to hospice patients. These measures are publicly available at no cost to hospice providers. In addition, the largest hospice industry group, the National Hospice and Palliative Care Organization, has launched a major quality initiative to provide hospices with the tools they need to begin collecting and analyzing QAPI data and to develop, implement, and analyze performance improvement projects. Furthermore, Brown University has made available the TIME Toolkit, which contains quality measures and related data elements that hospices may use in their QAPI programs. We are confident that these efforts, and others that may arise in the future, will help hospices transition from the quality assurance approach to the QAPI approach. For additional discussion of the former quality assurance requirements and the new QAPI requirements, see pages 30847-30849 of the May 27, 2005 hospice proposed rule (70 FR 30840).
We note that hospitals are currently required to comply with a very similar performance improvement project regulation and have successfully determined their performance improvement project needs and goals without prescribed minimums. Likewise, hospital surveyors have successfully assessed hospital compliance with the performance improvement project regulation without such minimums. We will use the knowledge gained through the hospital survey process to guide our understanding and implementation of surveys for hospices complying with this performance improvement project regulation.
There are no current requirements for infection control other than the requirements at § 418.100(a) that read in part, “each patient is to be kept comfortable, clean, well groomed, and protected from accident, injury, and infection,” and the requirement at § 418.100(e) regarding isolation areas. We proposed a new CoP to help manage the seriousness and hazards of infectious and communicable diseases.
We recognize that a hospice cannot be directly responsible for the maintenance of an infection-free environment in every setting. We proposed in § 418.60(a), “Prevention,” that hospices follow accepted infection control standards of practice and ensure that all staff that provide hospice services know and use these current best prevention practices to curb the spread of infection. Periodic training is one way to assure that staff take all appropriate infection prevention and control precautions. Hospices may also consider immunizing their patient care staff for influenza as part of their infection control programs. Hospice staff may transmit influenza to patients, compromising their quality of life at this important time, and to caregivers, compromising their ability to effectively care for the patient. Furthermore, infected staff may create a staffing shortage, compromising the entire hospice's ability to safely and effectively deliver care to all hospice patients and their families.
In § 418.60(b), “Control,” we proposed that the hospice be required to engage in an ongoing system-wide program that focuses on the surveillance, identification, prevention, control, and investigation of infections and communicable disease. Where infection and/or communicable disease are identified, we expect that this information would be made part of the hospice's quality assessment and performance improvement program.
As proposed in § 418.60(c), “Education,” each hospice would be expected to educate its staff, as well as patients, families, and other caregivers in the “current best practices” for controlling the spread of infections within the home during the course of the family/caregiver's interactions. We did not propose any specific approaches that a hospice would be required to adhere to. A hospice would be expected to aggressively seek to minimize the spread of disease and infection through its efforts to help families and caregivers understand what can and should be done to minimize infection.
Sections of current regulations at § 418.82, “Nursing services;” § 418.84, “Medical social services;” and § 418.92, “Physical therapy, occupational therapy and speech-language pathology,” identify detailed tasks that must be performed by agency staff. We proposed to remove § 418.82, § 418.84, and § 418.92, and replace them with a more simplified condition, “Licensed professional services.” Instead of identifying detailed tasks, we broadly described the expected contributions of the licensed professionals who are furnishing hospice services. Licensed professional services, for purposes of this section, would include, but not be limited to, skilled nursing care, physical therapy, speech language pathology, occupational therapy, and medical social services. We proposed that licensed professionals who provide services to hospice patients either directly or under arrangement would participate in coordinating all aspects of care, including updating the interdisciplinary comprehensive assessments, developing and evaluating plans of care, participating in patient and family counseling, participating in the quality assessment and performance improvement plan, and participating in in-service training.
The conditions of participation containing the current core services requirements are in § 418.80, “Furnishing of core services;” § 418.82, “Nursing services;” § 418.84, “Medical social services;” § 418.86, “Physician services;” and § 418.88, “Counseling services.” We proposed to combine these into a single condition. We also proposed to incorporate the requirement at existing § 418.50(b)(3) which required that core services would be provided in a manner consistent with accepted standards of practice. This section was revised to reflect changes to the Act made by section 946 of the MMA. In accordance with section 946 of the MMA, we proposed to allow a hospice (the primary hospice) to enter into arrangements with another Medicare-certified hospice to obtain core hospice services. The Act provided that this could be done under extraordinary or
In the first proposed standard, “(a) Physician services,” we incorporated the existing requirements of § 418.86. The existing and proposed requirement states that hospice physicians, in conjunction with the patient's attending physician, are responsible for the palliation and management of the terminal illness, conditions related to the terminal illness, and the general medical needs of the patient. As a result of changes made to the Act by the BBA, we also proposed to add a provision to the CoPs permitting hospices to contract for physician services. This proposed provision would align the CoPs with current CMS policy permitting hospices to contract for physician services.
The second proposed standard, “(b) Nursing services,” incorporated the requirements of § 418.82 of the existing CoPs. We also proposed to add specific language to address the role of nurse practitioners in providing hospice care. The services provided by nurse practitioners continue to be guided by Medicare statutory requirements. Within these statutory requirements, we propose to allow nurse practitioners to perform hospice functions that are within the scope of their practice and license, as well as within the laws of the State in which they practice.
We also proposed in § 418.64(b) to allow hospices to provide certain types of nursing services under contract. This proposed change also resulted from section 946 of the MMA, which amended the Act by adding section 1861(dd)(5)(E). As amended, the Act provides that these nursing services must be highly specialized and provided non-routinely and so infrequently that their provision by hospice employees would be impracticable and prohibitively expensive. We recognize that it may be cost-prohibitive for a hospice to employ a nurse that possesses very highly specialized skills when he or she may only care for a few patients a year. By allowing hospices to contract with specialized nursing providers or others to provide these highly specialized nursing services to the few patients who require them, hospices would be able to better implement an efficient staffing plan and ensure proficiency in the skilled services being provided.
In standard “(c) Medical social services,” we proposed to maintain the requirements of the current medical social services requirement at § 418.84. This standard would continue to require that medical social services be provided by a qualified social worker under the direction of a physician. This standard would also require that medical social services, when accepted by a patient and family, be based on an assessment of that patient's psychosocial needs. In proposed standard § 418.64(d), we addressed the counseling services that would be available to hospice patients and their families. Those services would be bereavement, nutritional, and spiritual counseling. In the bereavement counseling section, we proposed that a hospice would be required to have an organized program of bereavement services furnished under the supervision of a qualified professional with experience in grief/loss counseling. These services would be required to be made available to individuals identified in the bereavement plan of care up to one year following the death of the patient, and would reflect the needs of those individuals. When appropriate, residents and staff of a SNF/NF, ICF/MR, or other facility would be offered bereavement services.
In the nutritional counseling section, we proposed to allow qualified individuals, such as dietitians and nurses to furnish this service, provided that it was within their scope of practice and expertise according to State law. We believed that allowing other qualified individuals to participate in nutritional counseling would give hospices greater flexibility and would help ensure that all hospice patients had access to this service when needed. This proposal conformed to a recommendation made by the Secretary's Advisory Committee on Regulatory Reform.
In the spiritual counseling section, we proposed that a hospice would be required to assess the patient's and family's spiritual needs and provide spiritual counseling to meet those needs, in accordance with the patient's and family's beliefs and desires. If a patient and family did not desire spiritual counseling, then they would not have to be provided this service. If a patient and family did desire spiritual counseling, then a hospice would be expected to facilitate visits by local clergy, pastoral counselors, or others to the best of its ability.
We also agree that simultaneously providing continuous home care to multiple patients may result in an unanticipated period of high patient load that would warrant contracting for core services through the extraordinary circumstance exception. If a hospice chooses to contract with another Medicare-certified hospice or a non-hospice entity, the contracting hospice must maintain professional management responsibility for the services provided, in accordance with this final rule at § 418.100(e). In addition, all licensed professionals who provide services to hospice patients under contract must actively participate in the coordination of all aspects of the patient's hospice care, including patient assessments; care planning development, delivery, and
We do not believe that it is appropriate or necessary to state that medical directors are not required to furnish hands-on services to each patient. Elements of the proposed rule, such as the proposed requirement that the hospice medical director communicate with the medical director of a SNF/NF in proposed § 418.112(d), may have incorrectly implied that the hospice medical director would be expected to furnish direct care to every patient. We have removed or revised these elements to reflect the fact that the hospice IDG, including its physician member, is required to fulfill the role originally designated for the hospice medical director. Now that these implications have been removed, it is not necessary to explicitly state that the hospice medical director is not required to furnish care to each patient.
We proposed the provisions governing the role of nurse practitioners in hospice because the use of nurse practitioner services is prevalent in the hospice industry, and we have received numerous requests for this guidance for several years. Conversely, we are not aware of any need to address the role of physician assistants in hospice because, to our knowledge, physician assistant services are rarely used in hospices and are not recognized under the Medicare hospice benefit. We believe that there is no need to regulate services that are not used.
We agree that we need to revise the proposed rule requiring hospice physicians to assume responsibility for the general medical needs of the patient. This responsibility could well be beyond the scope of hospice physician services and could conflict with the responsibilities of other physicians furnishing services for needs unrelated to the patient's terminal illness and related conditions. Therefore, this proposed requirement has been removed. We have retained the requirement that, when the patient's attending physician is not available, a hospice physician is responsible for meeting the patient's medical needs. We do not believe that this requirement creates a conflict because it only applies when the attending physician is not available to perform his or her duties.
We do not believe that it is necessary to state that the contract for highly specialized nursing services need not be with another Medicare-certified hospice because we have revised the requirements for the general core services contract to permit hospices to contract with Medicare-certified hospices and non-hospice providers for core services under certain circumstances. Since hospices may contract with hospice and non-hospice providers for the general core services contract and for the highly specialized nursing skills contract, there is no need to differentiate between the two contracts.
In addition to effective supervision, it is essential that the individuals providing medical social services to hospice patients be qualified to provide these services. Section 418.114 addresses the personnel qualifications that social workers must meet in order to provide services to hospice patients. We have addressed the commenter's suggestion of requiring an MSW for social workers in the section addressing § 418.114 in the preamble of this final rule.
Supervision and qualifications both affect the scope of medical social services that are provided to patients. These services are required to be based on the needs of patients and families as those needs are identified through a thorough psychosocial assessment. Since the scope of services provided is directly tied to the needs of the patient and family, it is not possible to generically broaden their scope. Some patients and families may have limited social work needs, and should not be compelled to accept broader social work services that do not meet their needs.
We also believe that it is necessary to ensure that the individual supervising this thorough bereavement program is appropriately qualified. We agree that, in addition to experience, education in grief/loss counseling is an appropriate qualification for the program supervisor. We have made this change in § 418.64(d)(1)(i).
We also appreciate the support that we received regarding bereavement services furnished within a SNF/NF or ICF/MR. As we stated in the proposed rule preamble, there are times when facility staff and residents fulfill the role of a patient's family, providing caregiver services, being companions, and generally supporting the patient. We believe it is appropriate for a hospice to consider the bereavement needs of these individuals. However, we agree with commenters that requiring a hospice to offer bereavement services to facility staff may create a conflict between the hospice and the facility, which bears ultimate responsibility for its staff. Therefore, we have separated this requirement into two parts. A hospice may offer bereavement services to facility residents as identified in the patient's plan of care. Additionally, a hospice must include a provision in its contract with a facility that addresses the offering of bereavement counseling to facility staff. Through this contractual provision, hospices and facilities can mutually agree upon a plan that meets the needs of the hospice, the facility, and the staff (see § 418.112(c)(9)).
Additionally, we believe that the offer of bereavement services, as opposed to providing them, is the appropriate requirement for hospices to meet. Hospices cannot force bereavement services upon unwilling recipients; therefore, the bereavement plan of care is only able to state what services will be offered because it cannot predict what services will actually be accepted and provided. As such, we have revised § 418.64(d)(1)(iv) to state that the hospice is to, “[d]evelop a bereavement plan of care that notes the kind of bereavement services to be offered and the frequency of service delivery * * *.”
The requirements for obtaining a nursing services waiver as provided by section 1861(dd)(5) of the Act is currently set forth in § 418.83, and remained virtually unchanged in the proposed rule. This condition provides hospices the opportunity to obtain a waiver from the requirement that substantially all nursing services be routinely provided directly by the hospice. The Act specifies that to obtain a waiver a hospice must be located in
The current CoP governing non-core services is contained in § 418.90. We proposed to re-number the CoP and maintain its requirements, with slight language modifications. We also proposed to amend this CoP by adding language contained in § 418.50(b)(3) of the current rule, which states that non-core services must be provided in a manner consistent with current standards of practice.
There were no comments received on this condition of participation. Therefore, we are finalizing it as proposed.
Currently, the CoP concerning physical therapy, occupational therapy, and speech-language pathology is found at § 418.92(a). We proposed to recodify this CoP at § 418.72 without changes. This CoP requires hospices to make physical therapy, occupational therapy, and speech-language pathology services available to patients, and to ensure that these services are provided in a manner consistent with current standards of practice.
We proposed a new CoP that would provide for a waiver of certain requirements. This CoP would establish authority to waive the requirement that eligible hospices must provide physical therapy (PT), occupational therapy (OT), and/or speech-language pathology (SLP) services as needed on a 24-hour basis as otherwise required by section 1861(dd)(2)(A)(i). This CoP would also establish authority to waive the requirement that eligible hospices must provide dietary counseling services on a 24-hour basis and/or that eligible hospices must routinely provide dietary counseling services directly through hospice employees.
As in the case for a waiver of nursing services (proposed § 418.66), eligibility for a waiver is based on the primary location of a hospice. For a hospice that operates in multiple locations, its primary location is considered to be the location of its central office. This central office must be located in a non-urbanized area as determined by the Bureau of the Census. The hospice must provide evidence that it made a good faith effort (for example, copies of advertisements in local newspapers, documentation of competitive salaries and benefits, and evidence of recruiting activities) to hire a sufficient number of PTs, SLPs, OTs, and dietary counselors to provide services directly through hospice employees or under arrangement on a 24-hour as needed basis.
Section 1861(dd)(1)(D) of the Act requires Medicare covered home health aide services to be furnished by an individual who has successfully completed training or a competency evaluation program that meets the requirements established by the Secretary. This section also provides for coverage of homemaker services. Currently, the condition of participation concerning home health aide and homemaker services is set forth at § 418.94, which incorporates by reference the home health aide requirements of the home health agency CoPs at § 484.36. We proposed in § 418.76 to use most of the substance of the requirements of § 484.36. The home health aide CoP establishes that a home health aide must complete a State-established or other training program, and in § 418.76(b) we outline the requirements that this training must meet, which are similar, but not identical to, the provisions of § 484.36. In § 418.76(e) and § 418.76(f) we outline requirements for the individuals and organizations eligible to provide the aide training.
We proposed that three standards be particularly adapted for the hospice conditions of participation. First, § 418.76(h), “Supervision of home health aides,” would be revised from the current § 484.36(d), to require that a registered nurse or appropriate qualified therapist conduct an on-site supervisory visit no less frequently than every 28 days while the home health aide is providing care. This in-person supervisory visit would need to be conducted with at least one patient to whom the aide is providing services at the time. Thorough supervision of home health aides is crucial to ensuring that the patient's and family's needs are being met, and conducting supervisory visits when the aide is performing his or her duties is a key way to provide thorough supervision. Onsite supervisory visits will still be required every 14 days, as in the current rule at § 484.36(d)(2), but the aide would not be required to be present for these visits. This supervision schedule would allow hospices to maintain control over the quality and continuity of care being provided, and would help ensure that
Second, proposed § 418.76(j), “Homemaker qualifications,” was adapted from the existing § 418.94. The proposed standard would define a qualified homemaker as a home health aide, as described in § 418.76, or an individual who met the standards in § 418.202(g) and has successfully completed hospice orientation addressing the needs and concerns of patients and families coping with a terminal illness. Homemaker services, as noted in § 418.202(g), may include assistance in maintenance of a safe and healthy environment to enable the patient to benefit from care that is furnished.
Finally, § 418.76(k) would require a member of the IDG to coordinate homemaker services, and supply instructions for the homemaker on duties to be performed. The homemaker would be required to report all concerns about the patient or family to the member of the IDG who was coordinating the homemaker services. We have proposed these changes to ensure proper training and supervision, and to protect the quality of the homemaker services provided.
Determining those medications that are appropriate for aides to help administer is the decision of the IDG, based on the needs of the patient and family, the training of the aide, the policies of the hospice, and any applicable State and local laws and regulations. We do not require all hospice aides to be trained in medication administration because not all hospices will choose to have aides perform this task. Section 418.116 of this rule requires hospices to comply with all health and safety related State and local laws and regulations. State or local rules may very well prohibit hospice aides from administering medication. However, if medication administration is within the bounds of State and local rules, and if hospices do choose to have aides perform this task, § 418.76(b)(3)(xiii) requires those hospices to provide aide training for any other task that an aide is expected to perform, which would include medication administration. This, in conjunction with the requirement at § 418.76(g)(2)(iv), that aide services furnished must be consistent with hospice aide training, effectively requires medication administration training for those aides who are charged with assisting patients in administering medications that are ordinarily self-administered.
In addition to having the necessary assessment skills, it is important that registered nurses have a relationship both with the aide being supervised and the patient receiving the aide's services. Ideally, the RN responsible for supervising the aide is the RN chiefly responsible for the patient's nursing care. This allows the RN to develop a complete picture of the patient and family and of the aide's services. For this reason, we believe that it is necessary for hospices to identify a specific RN who will serve as the aide's supervisor during the care of a specific patient. We understand that, at times, it is necessary to use other RNs to fill-in and supervise aide services. If a substitute supervising RN is used, this should be noted.
At the same time, we have added a new requirement at § 418.76(h)(1)(ii) that requires hospices to conduct in-person supervisory visits to observe and assess aide skills if a potential deficiency in care furnished by the aide is noted in the regular 14-day supervisory visit (during which the aide is not required to be present). We believe that linking more frequent in-person supervisory visits to the actual performance of the aides will ensure that aides furnish quality care and that hospices have the flexibility to supervise their staff in a manner that meets their needs.
Since there may be occasions where a patient receives services through a personal care aide benefit while receiving hospice services, we agree with the commenters that this rule should address the responsibilities of the hospice for coordinating the care provided by hospice personnel and the Medicaid personal care aide. We have added new elements to address this, § 418.76(i)(2) and § 418.76(i)(3). Section 418.76(i)(2) provides that services furnished by the Medicaid personal care benefit may be used to the extent that the hospice would routinely use the services of a hospice patient's family in implementing a patient's plan of care. Section 418.76(i)(3) requires that a hospice coordinate hospice aide and homemaker services with the services furnished by the Medicaid personal care aide benefit to ensure that patients receive all the services that they require.
The current CoP for volunteers is located at § 418.70. We proposed to recodify this CoP at § 418.78 with minor changes. We proposed to remove the existing § 418.70(f), regarding the availability of clergy, because the role of the pastoral, clergy, or other spiritual counselor would be described as part of the IDG at proposed § 418.56(a)(1)(iv). This change would not preclude the hospice from continuing to use or starting to use clergy as volunteers. We did not propose any changes to the requirements to document cost savings and to maintain a sufficient level of volunteer activity.
We proposed to combine several conditions of the existing CoPs into a single new CoP. The proposed CoP included the requirements of current § 418.50, “General provisions,” § 418.52, “Governing body,” § 418.56, “Professional management,” § 418.60, “Continuation of care,” and § 418.64, “In-service training.” We believe that the proposed CoP simplifies the structure of the requirements, making them easier to understand. We also proposed to condense the list of all services that hospices are required to furnish into a single standard. We believe that this single list will emphasize hospice's holistic approach to patient and family care.
We made minor changes to the “General provisions,” “Governing body,” “In-service training,” and “Continuation of care” requirements. In § 418.100(e), “Professional management responsibility,” we proposed to revise some of the current requirements found at § 418.56(b) and § 418.56(c). This proposed standard would require written agreements for services furnished under arrangement, and would require that the hospice retain professional management, supervisory, and financial responsibility for all services that are provided to the patient and family. The hospice would be required to ensure that it authorizes all services that it provides, that they are furnished in a safe and effective manner by qualified personnel, and that items and/or services specified in the plan of care are provided.
We proposed to add a new standard to address the issue of multiple service locations. This provision was intended to codify long-standing Medicare survey
Before operating a multiple location, also known as a practice location on CMS form 855, a hospice must enroll with the fiscal intermediary and notify the State agency and CMS of all currently approved multiple locations at the time it requests approval for any additional multiple locations. If a hospice provides care and services to Medicare beneficiaries from an unapproved or disapproved multiple location, these services may be determined to be non-covered. At the time of any multiple location closure the hospice is expected to notify the fiscal intermediary, State agency and CMS. Hospice multiple locations are also subject to survey by the State survey agency or CMS regional office. Deficiencies that are identified at any multiple location will apply to the entire hospice issued the provider agreement number. Multiple locations must comply with the hospice conditions of participation at § 418.52 through § 418.116.
As previously stated, we relocated the requirement that hospices must exercise supervision and management over multiple locations from the definition of the term “multiple location” at § 418.3 to § 418.100(f)(1)(ii). Furthermore, we reorganized § 418.100(f) to group all requirements related to Medicare approval of multiple locations under a single regulatory element, § 418.100(f)(1), “Medicare approval.” We believe that grouping these elements will clarify our expectations for hospices seeking to operate multiple locations. Revised § 418.100(f)(1)(iii) now requires that the lines of authority, and professional and administrative control be clearly delineated in the hospice's organizational structure and in practice. It also requires that the lines of authority be traceable between the hospice location issued the certification number and all multiple locations. This new requirement further clarifies how a hospice must demonstrate supervision and management of the multiple location by the hospice issued the provider number. Revised § 418.100(f)(1)(iv) also includes a provision that a determination of whether or not a location qualifies as a multiple location in accordance with the considerations described above is an “initial determination” under § 498.3. An “initial determination” is an administrative action made by CMS, and is subject to appeal. Section 498.5 sets out the procedures for appellate review of CMS administrative actions that qualify as initial determinations. Therefore, hospices may appeal an unfavorable multiple location determination in accordance with the procedures of § 498.5.
In the preamble to the proposed rule, we described some of the factors that are currently examined when hospices apply to their CMS regional office for Medicare approval of a multiple location. The factors further explain what evidence must be presented by a hospice to CMS to demonstrate that the requirements of § 418.100(f)(1), such as supervision and management by the hospice issued the certification number, are met by the hospice. The factors, which will be updated in sub-regulatory guidance [(Pub. 100-7, Chapter 2, section 2081)] for this final rule, include, but are not limited to, the following:
The hospice's ability to supervise the multiple location to assure the provision of quality care for the patients and families served by the multiple location;
The hospice's past compliance history;
Relevant state issues and recommendations, such as a reciprocal agreement between states to assure that at least one of the state agencies assumes responsibility for any necessary surveys of multiple locations in situations in which a hospice provides services across State lines, certificate of need requirements, State licensure requirements, etc.; and
The ability of the hospice to ensure that each patient receives care from an assigned IDG that effectively works together to identify and meet the needs of the hospice patient and family.
Once a hospice has received approval from Medicare and the State (where applicable) to operate multiple locations, § 418.100(f)(2) requires that supervision and management of the multiple locations must continually ensure that services delivered through the multiple locations are delivered in a safe and effective manner, and that the care of each patient and family is provided in accordance with the plan of care. All care and services provided by multiple locations must be in accordance with all hospice conditions of participation at all times. Deficiencies
We proposed to revise the existing medical director requirements at § 418.54 in several ways. First, we proposed that the medical director could provide services under contract to the hospice. This proposal would have prohibited general contracts with agencies or organizations for medical director services, and reflected existing CMS policy, as permitted by section 4445 of the BBA 1997. Second, we proposed that another physician would be identified by the medical director to assume the role of the medical director in the medical director's absence. We believe that having another physician prepared to assume the medical director role would ensure continuity of care for the hospice's patients, even when the regular medical director was unavailable.
Third, in standard (a) and (b), we proposed to add further guidance on the factors that would need to be considered when certifying and recertifying the terminal illness. We believe that these factors, such as related diagnoses, current medication and treatment orders, and the patient's desire to continue hospice care, are already routinely considered by most medical directors when certifying and recertifying the terminal illness. Fourth, we proposed to further define the role of the medical director. We proposed that the medical director coordinate with other physicians and health care professionals to ensure that patients receive care that is consistent with hospice policy. Additionally, we proposed that the medical director, in tandem with the IDG, be responsible for patient medical care in its entirety. Finally, we proposed that the medical director be responsible for directing the hospice's QAPI program. We believed that these medical director responsibilities would ensure that the medical director was an active leader and participant in all aspects of the hospice's operations and services. We believe active participation would lead to better quality care and patient outcomes.
We believe the requirements in this final rule compliment and encompass the existing Medicare hospice certification requirements and may enhance the health and safety of patients by ensuring that hospices have all relevant information about a patient in the patient's record.
The proposed condition of participation, “Clinical records,” would
At § 418.104(a), “Content,” we proposed to retain the requirement that the clinical record include all assessments (including the initial assessment and all updated assessments), plans of care, consent and election forms, and clinical and progress notes. We proposed the following additional requirements for the content of the clinical record—
• Advance directive information as described in proposed § 418.52(a)(3);
• Authorization forms;
• Responses to medications, symptom management, treatments and services;
• Patient process and outcome measures as they relate to the plan of care; and
• Physician certification of terminal illness as required in § 418.22(c) and described in proposed § 418.102(a) and (b) (now (b) and (c) in the final rule).
We proposed to add a new standard at § 418.104(b), “Authentication,” to require authentication of clinical records. This proposed standard was similar to a requirement in the conditions of participation for hospitals. We proposed that all entries be legible, clear, complete, and appropriately authenticated and dated. Authentication would include verification of handwritten and/or electronic signatures by signature logs or a computer secure entry of a unique identifier for a primary author who has reviewed and approved the entry. This new standard would address technological changes in information management, such as the computerization of records and electronic signatures.
Under § 418.104(d), “Retention of records,” we proposed to ensure protection of patient information by adding a new requirement that patient records be retained for five years after the death or discharge of the patient, unless State law stipulated a longer period of time.
Under § 418.104(e), “Discharge or transfer of care,” we proposed a new requirement that Medicare/Medicaid-approved hospice facilities forward a copy of the patient's clinical record and hospice discharge summary to the facility or provider to which the patient was being transferred. We believe that this would help to ensure that the information flow between the hospice and the transfer facility/provider would be smooth, and that appropriate care would continue without being compromised. Furthermore, we proposed that the hospice discharge summary would include information that accurately described the patient's stay; current plan of care; recent treatment, symptom, and pain management information; most recent physician orders; and any other documentation that would assist in post-discharge continuity of care.
In the reorganization of § 418.104(e) we believe we captured the commenters' concerns in the area of discharge summary. We recognize that the discharge summary and clinical record are very important, and have amended the language to specify that the discharge summary will be sent automatically, but that a copy of the patient's entire clinical record will only be sent if requested. When patients transition from a hospice to another provider, it is important for hospices to establish communication channels with receiving providers. The communication channels give hospices to opportunity to receive feedback from receiving providers regarding the adequacy and appropriateness of the hospice's discharge process. This feedback, which can be incorporated into a hospice's QAPI program, gives hospices the opportunity to improve patient transitions to ensure that patients receive safe and effective care at all times during the transfer process.
Promoting the use of health information technology (HIT) is a major health initiative of the President and the Secretary of the Department of Health and Human Services (HHS). The President has made implementation of interoperable HIT a national priority and has expressed a goal that most Americans have an electronic health record (EHR) by 2014. While this rule does not require hospice providers to use specific health information technology solutions, including EHRs, we encourage hospice providers to become knowledgeable about ongoing HHS activities and actively participate in efforts to develop and implement cost-effective HIT. For example, one activity recently undertaken by the Secretary has been the formation of the American Health Information Community (AHIC), a public-private sector federal advisory body charged with providing advice on accelerating the adoption of interoperable EHRs. In another effort, the Health Information Technology Standards Panel (HITSP) has identified widely accepted, consensus-based HIT standards to enable and support the development and use of interoperable HIT products in several healthcare domains. While HITSP did not focus on the quality measures that are typically important to hospice providers, several of the identified standards could be used to support the development of interoperable quality measurement and reporting HIT products needed by hospice providers.
This proposed condition of participation would revise the current general requirement, found at § 418.96, that durable medical equipment, supplies, appliances, and drugs and biologicals related to the palliation and management of the terminal illness and related conditions, as identified in the hospice plan of care, must be provided by the hospice while the patient is under hospice care.
Section 418.106(a)(1), “Administration of drugs and biologicals,” would have required that all drugs and biologicals be administered in accordance with accepted hospice and palliative care standards of practice and according to the patient's plan of care. In § 418.106(a)(2) we proposed to add a new requirement that the IDG be responsible for reviewing the plan of care to determine whether the patient and/or family has and continues to have the ability to safely administer drugs and biologicals.
In § 418.106(b), we proposed that the hospice would have a written policy for tracking, collecting and disposing of controlled drugs that are maintained in a patient's home. We proposed that this policy would be discussed with patients and their families during the initial assessment to ensure that patients and families were educated about the uses and potential dangers of controlled drugs. We believe that the hospice's policy, coupled with patient and family education, would result in shared responsibility for these beneficial, but potentially dangerous, drugs.
Standard 418.106(c) proposed that hospices assume responsibility for the use and maintenance of durable medical equipment and supplies. This standard proposed that hospices, either directly or under contract, would be responsible for ensuring the maintenance and repair of durable medical equipment in a manner that conformed to manufacturer recommendations. If no manufacturer recommendations existed for a piece of equipment, then repair and routine maintenance policies and procedures would have to be established. This standard also proposed that the hospice ensure that the patient, family, and all other caregivers receive instruction in the safe use of equipment and supplies. Likewise, the hospice would have to ensure that the patient, family, and other caregivers could demonstrate the safe use of such equipment and supplies to the satisfaction of hospice staff. We believe that proper maintenance and education are essential to ensuring the patients benefit from fully functional equipment and supplies that they are able to use in a safe and effective manner.
In new standard (a), “Managing drugs and biologicals,” we combined some of the requirements of proposed § 418.110(m) and § 418.110(n), such as the proposed requirement that a qualified licensed pharmacist direct the inpatient hospice's pharmaceutical services, including evaluation of a patient's response to drug therapy, and identification of adverse drug reactions. New standard (a) requires the hospice to ensure that the interdisciplinary group confers with an individual with education and training in drug management as defined in hospice policies and procedures and State law, who is an employee of or under contract with the hospice to ensure that drugs and biologicals meet each patient's needs.
Hospices may choose to use a licensed pharmacist, an individual who has an extensive and up-to-date knowledge of drugs, to fulfill this role. Approximately 1,600 hospices already contract with pharmacy benefit management companies to provide drugs and pharmacist services to each of their patients. Hospices may also choose to use other individuals with specialized education and training in drug management, including evaluating the effectiveness of drug therapies, identifying drug side effects, identifying actual or potential drug interactions, identifying redundant drugs, and taking appropriate corrective actions. All hospices must be able to demonstrate an individual's knowledge, skills, and abilities in managing the use of drugs in accordance with accepted standards of practice and all applicable State and local requirements, including State licensure requirements.
Standard (a)(2) also incorporates the proposed requirements of § 418.110(m) and § 418.110(n) that a pharmacist must oversee an inpatient hospice's pharmacy program. The provided pharmacist services must include evaluation of a patient's response to medication therapy, identification of potential adverse drug reactions, and recommended appropriate corrective action. New standard (b), “Ordering of drugs,” relocates the requirements of proposed § 418.110(n)(1). This new standard indicates who may order drugs for a hospice patient and how verbal or electronic drug orders should be documented. New standard (c), “Dispensing of drugs and biologicals,” combines some of the requirements of proposed § 418.110(m), with proposed § 418.110(n)(4)(ii). This new standard requires a hospice to have a written policy that promotes dispensing accuracy, to maintain current and accurate records of the receipt and disposition of all controlled drugs, and to obtain drugs and biologicals from community or institutional pharmacists or from its own stock. New standard (d), “Administration of drugs and biologicals,” combines the requirements of proposed § 418.106(a)(2) and § 418.110(n)(2). The new standard addresses drug administration in both the home and hospice inpatient facility environments to ensure that drugs and biologicals are administered to a patient by an individual who is competent to do so, regardless of the patient's current environment.
New standard (e), “Labeling, disposing, and storing of drugs and biologicals,” combines and revises the requirements of proposed § 418.106(b) and § 418.110(n)(3), (n)(4)(i), (n)(4)(iii), and (n)(5). This new standard ensures that drugs are safely labeled, stored, and disposed of in accordance with accepted standards of practice and applicable Federal and State laws and regulations. It also ensures that patients and families are properly educated about drug disposal.
We understand that the revised drug requirements may have some financial impact on hospices. However the cost saving achieved through a more efficient and effective use of drugs in the hospice, as well as improved patient outcomes and satisfaction, will, we believe, offset a portion of this financial impact. Additionally, we believe that the new standards (for example, development of hospice-wide policies and procedures, patient and family education) will help hospices create partnerships with patients and families to ensure that controlled drugs are used and disposed of in a safe manner.
“If the patient and/or family are determined to be unable to safely administer drugs and biologicals, the patient and family will be encouraged to relocate the patient to a setting where administration assistance can be routinely offered. However, it is recognized that the patient, if competent, and the patient's surrogate if the patient is not competent, can refuse to relocate. Given patient rights and the home setting, [the] hospice will be expected to provide reasonable
While we are requiring hospices to provide drug policy and procedure information to patients and families, we are not prescribing the manner in which they must document this information sharing. The drug policy and procedure information, unlike the notice of patient rights in § 418.52, is more of an educational effort. The hospice's drug policies and procedures will help patients learn how to safely use controlled substances and avoid negative outcomes. The drug policies and procedures will also help the hospice explain its own role in controlled drug management. We do not believe that it is necessary to dictate the method for educating patients and families about the hospice's drug policies and procedures, nor is it necessary to prescribe how hospices should document that patients and families have received such education. Hospices should decide for themselves, in their own policies and procedures, how staff will document the discussion of the hospice's drug policies and procedures. Obtaining a patient or family member signature would be appropriate, as would any number of other documentation methods.
As previously discussed in the notice of patient rights section, it is acceptable to use translators, either professional or family members, to ensure that patients and families fully understand the hospice's controlled drugs policies and procedures.
At the same time, we understand that the proposed requirements should be clarified to ensure that hospices may provide DME maintenance services under contract. We have revised new § 418.106(f)(1) to state that hospices must ensure that manufacturer maintenance recommendations are followed. If there are no manufacturer recommendations, hospices must ensure that maintenance policies are developed. We believe that adding the term “ensure” will clarify that hospices must make sure that such maintenance is complete, but that hospices are not necessarily required to handle maintenance through their employees.
We are aware that the appearance of a conflict of interest or an actual conflict of interest could exist when a pharmacist or pharmacist service under contract to the hospice recommends one brand name drug over another, favors one drug in a therapeutic class over another, or recommends an increase in the utilization of a specific drug. For example, a conflict of interest exists when a pharmacist under contract to the hospice is employed by the pharmacy that supplies drugs to the hospice and that pharmacy accepts access/performance rebates or other price concessions designed to or likely to influence or impact utilization of drugs in the hospice. The term “access/performance rebates” refers to rebates manufacturers provide to pharmacies that are designed to prefer, protect, or maintain that manufacturer's product selection by the pharmacy or to increase the volume of that manufacturer's products that are dispensed by the pharmacy under its formulary (referred to as “moving market share”). If a conflict of interest exists, it has the potential to compromise the judgment of the pharmacist which could affect the care of a patient. The hospice IDG retains responsibility for all patient care decisions independent of others, and it is inappropriate for a pharmacist or any other member or consultant of the IDG to drive patient care decisions based on financial or business incentives. It is incumbent upon a hospice to obtain assurance that a contracted pharmacist or pharmacist service is free of any potential or real conflicts of interest or financial incentives.
Under § 418.108, we proposed to retain the requirement that hospices make inpatient care available for pain control, symptom management, and respite purposes, and that care be provided either in the hospice or in a participating Medicare or Medicaid facility. We proposed to recodify the current standard found at § 418.98(a), “Inpatient care for symptom control,” as § 418.108(a), “Inpatient care for symptom management and pain control.” We proposed to recodify the current standard found at § 418.98(b), “Inpatient care for respite purpose”, as § 418.108(b), with the same title and only minor terminology changes.
We proposed to eliminate the existing requirement found at § 418.100(a)(2), requiring that a registered nurse provide direct patient care on each shift. In its place, we proposed that the patient's plan of care and the patient's condition should determine the amount and skill level of nursing care required, as well as the skill level and State licensing requirements of the staff required to provide requisite care.
Under proposed § 418.108(c), “Inpatient care provided under arrangement,” we proposed to incorporate the requirements of existing standard 418.56(e), “Inpatient care.” In particular, we proposed to require that, if a hospice chose to contract with another type of facility to provide inpatient care, the hospice would have to include in its contract a provision that it would train the personnel who would be providing hospice patient care in the inpatient facility (currently at § 418.56(e)(5)). We believe the training is necessary because the hospice palliative model of patient care is very different from the curative model of patient care in which medical personnel are routinely trained. We also proposed that, as part of the contract, a copy of the inpatient clinical record and discharge summary would have to be available to the hospice at the time of discharge from the inpatient facility.
Under proposed § 418.108(d), “Inpatient care limitation,” and § 418.108(e), “Exemption from limitation,” we proposed to re-codify the existing parallel requirements at § 418.98(c) and (d) respectively, without changes, because these requirements are derived directly from section 1861(dd) of the Act.
While we understand that care of the respite patient is much different than care of the general inpatient, we do not have regulatory authority over assisted living facilities or group homes. Therefore, to maintain continuity and safe care of the respite patient, we require that all respite care be provided in Medicare or Medicaid certified inpatient facilities. This in no way prohibits a hospice patient from residing in an assisted living facility or licensed group home.
We proposed to recodify most of the requirements of existing § 418.100 at § 418.110, with some revisions. We proposed to recodify, without change, the requirements of § 418.100(d), “Fire protection,” at § 418.110(d); § 418.100(e), “Patient areas,” at § 418.110(e); § 418.100(f), ”Patient rooms and toilet facilities,” at 418.110(f) and (g); § 418.100(g), “Bathroom facilities,” at § 418.110(h); § 418.100(h), “Linen,” at § 418.110(k); and § 418.100(k), “Pharmaceutical services,” at § 418.110(m) and (n).
We proposed to replace existing § 418.100(a) with § 418.110(a), “Staffing,” and § 418.110(b), “24-hour nursing services.” The existing regulation requires that a registered nurse must provide direct patient care on each shift. The two proposed standards provide some flexibility and would require hospices that provide inpatient care in their own inpatient facilities to ensure that staffing for all services, including nursing services, is adequate, based on the volume of patients, their acuity, and the level of services they need. These standards further proposed that staffing must meet the needs of patients to ensure that each patient's plan of care is adhered to and that the outcomes described in each patient's plan of care are achieved. Finally, these standards proposed that nursing services must be adequate to ensure that each patient is kept comfortable, clean, well-groomed, and protected from accident, injury, and infection. We believe that this outcome-based approach meets the needs of patients and hospices without using prescriptive requirements.
At § 418.110(c), “Physical environment,” we proposed that the hospice maintain a safe physical environment that was free of hazards for patients, staff, and visitors. In § 418.110(c)(1), “Safety management,” we proposed that the hospice prevent situations that posed a real or potential threat to the health and safety of the patients, others, and property. The hospice would be required to promptly investigate, correct, and report to appropriate State and local bodies with jurisdiction all breaches of safety. The hospice would be required to take steps to prevent equipment failures, and correct and report any equipment failures promptly.
In addition, § 418.110(c)(1)(iii) proposed to retain the existing requirement at § 418.100(b) that the hospice periodically rehearse with staff a disaster preparedness plan for managing the consequences of natural disasters and other emergencies that affect the hospice's ability to provide care. In developing and rehearsing their disaster preparedness plans, we believe that it is important for hospices to be engaged with their local and state disaster preparedness planning counterparts. Although this disaster preparedness requirement applies only to hospice inpatient facilities, we encourage all hospices to be aware of the need for disaster planning at the hospice, local, and State levels, and to actively engage in the planning process. We also proposed, at § 418.110(c)(2), that the hospice develop procedures for managing trash and medical waste disposal; light, temperature and ventilation; emergency gas and water supplies; and equipment maintenance and repairs. We believe that these basic precautions and actions will help the hospice ensure that buildings, as well as the equipment inside of them, are fully and safely functioning at all times to ensure patient and family comfort and satisfaction.
Proposed § 418.110(f), “Patient rooms,” would recodify and revise the requirements of existing 418.100(f). We proposed in § 418.110(f)(3)(iv) that each room accommodate no more than two patients because we believe that hospice patients and families need the additional privacy that a two-patient room affords them in order to help preserve the patient's comfort and dignity during the dying process. We believe this is the standard accommodation in most facilities. We proposed to allow existing hospice facilities with more than two patients in each room to receive a waiver of this requirement. This waiver would be based on whether the hospice was already providing direct inpatient care in a non-compliant facility when this regulation became effective. That is, if a hospice was providing direct inpatient care in a non-compliant building on the day before the effective date of the final rule and could demonstrate that the imposition of a two-patient-per-room requirement would result in unreasonable hardship or jeopardize its ability to continue to participate in Medicare or Medicaid, then the hospice operating in the non-compliant building could qualify for a waiver of the proposed requirement. A hospice would have to demonstrate to CMS that the waiver served the needs of its patients and did not adversely affect their health and safety. If that same hospice moved into a non-compliant building after the effective date of this final rule, then the hospice would be deemed out of compliance with our rules. If a hospice chose to begin operating its own inpatient unit after the effective date of this final rule, then it would not qualify for the proposed waiver, and would be required to have no more than two patients per room. The remaining paragraphs in this standard would be virtually the same as in the current requirement, with only minor revisions to the language that would not change the substantive requirements of the regulation.
In § 418.110(i), “Infection control,” we proposed to revise the infection control standards to conform to those required of other provider types, such as home health agencies and hospitals. We proposed to require a hospice to establish an infection control program that would protect patients, families, and staff against communicable diseases and would prevent and control the
In § 418.110(l), “Meal service and menu planning,” we proposed to revise the existing § 418.100(j). We proposed to make this standard less restrictive by eliminating several structural requirements, such as serving at least three meals at regular times, with no more than 14 hours between substantial evening and breakfast meals, and having a staff member trained in food management or nutrition. In place of these prescriptive requirements, we proposed that a hospice should focus on meeting the individual patient's nutritional and plan of care needs.
We proposed a new standard at § 418.110(o) to address the use of seclusion and restraints in hospice inpatient facilities. Anecdotal evidence indicates that seclusion and restraints are occasionally used in hospice inpatient facilities ostensibly to protect patients, visitors, and/or staff. The proposed requirements, modeled on those for hospitals issued by CMS in 1999, and on the requirements of section 3207 of the Children's Health Act (Pub. L. 106-310), would ensure that, when seclusion or restraints are used, they are used in a safe manner for the shortest time necessary to ensure patient and staff safety.
The proposed standard, divided into seven elements, focused on the proper use of seclusion and restraints, and on the need for hospice personnel to receive training and education both in the proper use of seclusion and restraint application and techniques, and in the use of alternative methods for handling situations that arise. The standard proposed specific requirements for physician orders for seclusion or restraint (for example, consultation with the hospice medical director, 1 hour face-to-face evaluation of the patient, and time limits on the length of orders). The proposed standard also included a requirement that a hospice would have to report to its CMS regional office any death that occurs while a patient is restrained or in seclusion, or that occurred within 24 hours of a patient being removed from seclusion or restraint.
Hospices may authorize their medical director, physician designee, other hospice physician employees, and/or attending physicians to issue restraint or seclusion orders. If an order for seclusion or restraint is not ordered by the attending physician, medical director, or physician designee, then the medical director or physician designee must be consulted as soon as possible after the order is issued.
Once an order for seclusion or restraint is issued and implemented, the patient must be seen within one hour to evaluate the need for continuing the intervention. We agree that it may be difficult for a hospice physician to arrive at the inpatient facility and actually see the patient within this one-hour window. Therefore, we have added a provision permitting a registered nurse trained in the proper use of seclusion and restraint to conduct the one-hour face-to-face evaluation of the patient.
In addition to the one-hour evaluation, we believe that it is necessary to regularly re-evaluate the patient's status and need for the ordered intervention. To ensure a thorough re-evaluation, we are requiring orders for seclusion or restraint to last no more than four hours each for a total of up to 24 hours. We believe that frequently re-ordering the intervention will ensure that patients remain in seclusion or restraint for the shortest time possible to control their distress.
Should a seclusion or restraint-related death occur, our intent is to ensure that hospices fully investigate the death and notify CMS of the death and the investigation findings. We have clarified that the seclusion and restraint investigation and reporting requirements in final standard § 418.110(o), “Death reporting requirements,” only apply to those patients who die unexpectedly.
Section 592 of the PHS Act requires facilities to report all deaths within 24 hours after a patient is removed from restraint or seclusion, or where it is reasonable to assume that a patient's death is a result of such seclusion or restraint. Therefore, we have also clarified that unexpected deaths occurring within 24 hours of a patient being removed from seclusion and/or restraints would need to be investigated. We believe that unexpected deaths require a full investigation by the hospice to determine the presence or lack of a relationship between the seclusion and/or restraint and the patient's death. We also believe that CMS must be apprised of such situations because a patient death related to seclusion and/or restraint use may indicate the presence of patient safety issues within the hospice that require additional guidance from the State or CMS. It is important to remember that we are in no way seeking to discourage the use of seclusion and restraint if, within these regulatory boundaries, their use will benefit a patient. Our goal is to ensure that seclusion and restraint, when used, are used in a safe manner for the shortest amount of time necessary, as required by the PHS Act.
We currently do not separately address the provision of hospice care to a hospice-eligible resident of a facility. This includes hospice care provided to residents who choose to live in skilled nursing facilities, nursing facilities, intermediate care facilities, and many other types of facilities. The provision of, and questions related to, hospice care for residents of those facilities has come under scrutiny as a result of a variety of report findings, including Operation Restore Trust (ORT) activities, Inspector General (OIG) reports from 1996, 1997, and 1998, and a 2000 report from the Department's Assistant Secretary for Planning and Evaluation (ASPE) Office of Disability, Aging and Long-Term Care Policy and the Urban Institute. (U.S. D.H.H.S. OIG, “Hospice and Nursing Home Contractual Relationships,” Nov. 1997, OEI-05-95-00251; OIG Special Fraud Alert, “
Based on the recommendations of the committee, as well as the reports from Operation Restore Trust, the Office of the Inspector General, and ASPE, we proposed to add a new condition at § 418.112, “Hospices that provide care to residents of a SNF/NF, ICF/MR, or other facilities.” We are also preparing a separate regulatory document to address long-term care facility obligations regarding residents receiving hospice services.
Under § 418.112(a), “Resident eligibility, election and duration of benefits,” we proposed that the hospice ensure that the resident met all the same Medicare eligibility requirements for hospice care (found at § 418.20 to
At § 418.112(b), “Professional management,” we proposed that the hospice assume full responsibility for all of the hospice care provided to the patient. This would include making arrangements for any inpatient care that the patient would require in accordance with § 418.100. This standard would reinforce the necessity of continuity of care for patients who reside in a SNF/NF, ICF/MR, or other facility. In § 418.112(c), “Core services,” (and in accordance with sections 1861(dd)(1) and (2)(A) of the Act), we proposed that the hospice be required to provide all necessary core services to its patients residing in a SNF/NF, ICF/MR, or other facility in the same manner that it would provide such core services to a patient residing in a home in the community. It is not reasonable for the hospice to delegate any of its standard hospice core services to the nursing or residential facility staff.
In § 418.112(d), “Medical director,” we proposed that a hospice medical director would be expected to communicate with all facility physicians, including the facility's medical director, and the attending physician and other professionals involved in developing and/or implementing the patient's plan of care. This standard was designed to ensure that all physicians, including those in leadership positions, were in agreement regarding the patient's care to ensure that duplicative and/or conflicting physician orders are not issued for patient care.
Under § 418.112(e), “Written agreement,” we proposed that a comprehensive written agreement be developed between the hospice and facility, and that it be in effect before any hospice care was provided to a facility resident. The purpose of the written agreement would be to ensure that the duties and responsibilities of the hospice and facility were clearly articulated and executed in a manner that ensured that the patient would receive quality hospice care. The written agreement would be required to include the following:
(1) Written consent and documentation of the patient or the representative's desire for hospice services.
(2) Identification of the services that the hospice and the facility would provide.
(3) The manner in which the facility and the hospice would communicate to ensure that the needs of the patient were addressed and met 24 hours a day.
(4) A requirement that the facility immediately notify the hospice when:
(A) A significant change in the patient's physical, mental, social or emotional status occurred;
(B) Clinical complications appeared that suggested a need to alter the plan of care;
(C) A life threatening condition(s) appeared;
(D) A need to transfer the patient from the facility arose; or
(E) The patient died.
(5) A provision stating that the hospice assumed responsibility for determining the appropriate course of care, including the determination to change the level of services provided. (An agreement that it was the facility's primary responsibility to furnish room and board.)
(6) A delineation of the hospice's responsibilities, which would include, but not be limited to, providing medical direction and management of the patient, nursing, counseling (including spiritual and dietary counseling), social work, bereavement counseling, provision of medical supplies and durable medical equipment, provision of drugs necessary for the palliation of pain and symptoms associated with the terminal illness and related conditions, as well as all other hospice services that might be necessary for the care of the resident's terminal illness and related conditions.
(7) A provision that the hospice could use the facility's nursing personnel where permitted by law and as specified by the facility to assist in the administration of prescribed therapies included in the plan of care, but only to the extent that the hospice would routinely use the services of a hospice patient's family in implementing the plan of care.
These would be mandatory agreement provisions, but would not otherwise limit the scope or content of the relationship between the hospice and the facility. Additional provisions could be added subject to mutual agreement.
Under § 418.112(f), “Hospice plan of care,” we proposed that the content of the plan of care for a patient residing in a SNF/NF, ICF/MR, or other residential facility would be similar to the content of the plan of care for a patient residing in a home in the community. The plan would have to reflect the hospice philosophy in all aspects, be based on an assessment of the patient's needs and unique living situation in the facility, and be updated at least every 14 calendar days. In addition to the standard plan of care requirements, the plan of care for a patient residing in a SNF/NF, ICF/MR, or other facility would be required to be coordinated with and developed by the hospice IDG and SNF/NF, ICF/MR, or other facility in collaboration with the attending physician. Furthermore, the plan of care would have to specify which provider would be responsible for providing a particular form of care. The performance of the functions would reflect the participation of the hospice, SNF/NF, ICF/MR, or other facility, and the patient and family to the extent possible.
At § 418.112(g), “Coordination of services,” we proposed that the hospice designate a member of the IDG to coordinate the implementation of the plan. The hospice would provide the residential facility with the plan of care, hospice consent form, contact information for hospice personnel involved in the care of the resident, instructions on accessing the hospice 24-hour on-call system, medication information specific to the patient, physician orders, and any advance directives. We believe that these requirements would ensure effective communication between the hospice and the facility.
Under § 418.112(h), “Transfer, revocation, or discharge from hospice care,” we proposed to cross-reference the proposed requirement for discharge or revocation at § 418.104(e). In addition, we proposed that discharge or revocation of the hospice care would not impact the eligibility to continue to reside in a SNF/NF, ICF/MR, or other facility.
At § 418.112(i), “Orientation and training of staff,” we proposed that the hospice staff would be required to train facility staff who provided care to hospice patients on aspects of the hospice philosophy and unique program features, including policies and procedures, methods of comfort, pain control and symptom management, general principles about death and dying and individual responses, patient rights, appropriate forms, and record keeping requirements.
Through these mechanisms, the hospice maintains responsibility for all of its care and services for all of its patients and ensures that the care it is providing complements the care being provided by others. In addition to these mechanisms used for all patients, hospices are required to establish written agreements and communication systems with SNFs, NFs, and ICFs/MR when hospices are furnishing hospice care to residents of those facilities. Clear communication between the hospice and the SNF/NF or ICF/MR will help hospices ensure that they are meeting their responsibility to furnish the care necessary to meet the needs of its patients.
We proposed that hospices may only use the staff of the SNF/NF or ICF/MR as specified in the written agreement signed by the SNF/NF or ICF/MR. This is being retained in the final rule at § 418.112(c)(7). It recognizes that facilities must give consent for their staff to be used in caring for the hospice patient and must determine the extent of staff involvement. This consent allows facilities and hospices to match their corresponding levels of available personnel service to the needs of the patients being served. As stated above, hospices are not responsible for assuming the functions that the SNF/NF or ICF/MR performed for the patient before the patient elected to receive hospice care. Likewise, SNFs/NFs and ICFs/MR are not responsible for assuming the functions that the hospice would provide for a patient residing in his or her own home.
The hospice benefit is not designed so that hospice personnel routinely provide 24-hour care or serve as the patient's primary caregiver. Hospice patients in their private homes have private caregivers, be they family members, friends, hospice volunteers, paid assistants, or any of a number of other combinations. These caregivers are trained by the hospice to administer care in accordance with the patient's plan of care. Caregivers may help patients with a variety of duties, such as medication administration, bathing, and housekeeping.
Hospice patients in SNFs/NFs and ICFs/MR depend, at least in part, on facility staff to provide caregiver services. As such, we believe that it is reasonable to allow hospices to use facility staff who act as caregivers in the same manner and to the same extent that hospices would use family members, friends or other caregivers who care for patients in their private residences. For example, hospices typically instruct home caregivers in how and when to administer medications to hospice patients. Therefore, it would be appropriate to instruct facility staff caregivers in how and when to administer medications. Hospices typically do not instruct home caregivers in how to draw blood to monitor medication levels; thus it would not be appropriate to expect facility staff to draw blood, even though some members of the facility's staff may be competent to do so. Hospices are to use facility staff in the same way that they would use home caregivers to implement the patient's plan of care. While facility staff presumably possess more sophisticated health care skills than home caregivers, they may not be used to perform functions more frequently, or with a greater degree of complexity, than the hospice would utilize home caregivers under similar circumstances.
We understand that, in times of crisis, it may be necessary for a hospice to direct staff of the SNF/NF or ICF/MR to perform more sophisticated functions than caregivers would typically perform in order to ensure patient comfort while
We understand that this does not provide the exact specificity of what functions may or may not be performed by facility caregivers that some commenters sought. We cannot provide an absolute list because such a list is subject to many variables (for example, patient needs, provisions of the written agreement, staff skill levels, etc.).
We would like to clarify that the written agreement requirements only apply to hospice patients who are residents of SNFs/NFs and ICFs/MR. The written agreement, and the remaining requirements of § 418.112, do not apply to hospice patients who are placed in SNFs/NFs for general inpatient or respite care by the hospice itself. Rather, the requirements for the written agreement between a hospice and a facility that furnishes general inpatient or respite care are described in § 418.108(c).
Additionally, the designated IDG member must ensure that the hospice IDG communicates with the SNF/NF or ICF/MR medical director, the patient's attending physician, and any other physicians caring for the patient as needed to coordinate the patient's hospice care with the care provided by other entities. We believe that this new requirement will alleviate the demand on the hospice and facility medical directors while actively involving all members of the patient's care team, both within the hospice and the facility, in care planning and delivery.
The commenters believe that requiring this would reinforce the fact that the hospice and the facility have separate, but coordinated plans of care for each patient. Other commenters suggested that, in addition to the original hospice plan of care, facilities should also be provided with updated plans of care. Still other commenters suggested that hospices should provide SNFs/NFs and ICFs/MR copies of each patient's initial certification and recertification of terminal illness forms.
At the same time, we note that the entire purpose for using outside hospices to furnish hospice care to facility residents is to fulfill a need that the facility is not able to fulfill on its own. If a facility is unable to provide hospice care because it lacks the capability to do so, then the facility is certainly not qualified to orient its staff in hospice philosophy. Furthermore, the facility would not be qualified to orient its staff in a particular hospice's policies and procedures, patient rights, forms, and record keeping requirements. In that case, the hospice working with the facility needs to provide information, guidance and/or staff to assure orientation of the facility staff.
Since the core services requirement at § 418.64 applies, regardless of where services are provided, hospices are not permitted to routinely delegate hospice services to the staff of a SNF/NF or ICF/MR. Hospices are required to routinely provide substantially all core services directly. Hospices may only provide core services under arrangement if they meet the conditions for an extraordinary circumstance exemption described in § 418.64, the nursing services waiver described in § 418.66, or the nursing shortage waiver described in CMS S&C letter 05-02.
• The manner in which long term care facilities may furnish hospice services to their residents;
• The minimum content of the written agreement between the long term care facility and the hospice;
• The conditions under which the long term care facility must contact the hospice;
• The participation and coordination of the long term care facility in care planning and delivery; and
• The information that the long term care facility must obtain from the hospice.
We agree that, without this requirement in the long term care facility regulations, it will be challenging for hospices to comply with the requirements of this CoP. We will work with the hospice and long term care industries to address any situations that may occur during the intervening time period.
We proposed significant revisions to the personnel qualifications for hospice employees. Specifically, we proposed to provide that in cases where personnel requirements are not statutory, or do not relate to a specific payment provision, personnel would only be required to meet State certification or licensure requirements.
In § 418.114(a), “General qualifications,” we proposed that licensed professionals who provide hospice services directly, either as employees or under individual contract, or under arrangement with a hospice must be licensed, certified, or registered to practice by the State in which they perform the functions, as applicable. All personnel who fall into this category must act exclusively within the scope of the State license, certification or registration. In proposed § 418.114(b), “Personnel qualifications for physicians, speech-language pathologists, and home health aides,” we proposed to include those personnel requirements that are included in the Act.
When a State does not have a licensure, certification, or registration requirement, the hospice would apply the qualifications in proposed § 418.114(c), “Personnel qualifications when no State licensing laws or State certification or registration requirements exist.” This category would consist of all personnel qualifications specified in existing § 418.3, “Definitions,” including a requirement that a social worker have a baccalaureate degree from a school of social work accredited by the Council on Social Work Education (proposed § 418.114(c)(7)).
In § 418.114(d), we proposed a new requirement that a hospice obtain a criminal background check for all hospice and contract employees before employment at the hospice. We believe that this is an important safety measure to protect both patients and the hospice. We did not propose any specific type, scope, or frequency requirements for completing the background check.
• Have a Master of Social Work (MSW) degree from a school of social work accredited by the Council on Social Work Education, and one year of experience in a health care setting;
• Have a baccalaureate degree in social work (BSW) from a school of social work accredited by the Council on Social Work Education, and one year of experience in a health care setting; or
• Have a baccalaureate degree in psychology, sociology, or other field related to social work, and at least one year of social work experience in a health care setting.
If a hospice chooses to employ a social worker with a baccalaureate degree in social work, psychology, sociology, or other field related to social work, the services of that baccalaureate social worker must be provided under the supervision of a social worker with an MSW from a school of social work accredited by the Council on Social Work Education and one year of experience in a health care setting. We believe that requiring MSW supervision of BSW services will help ensure that patient and family needs are met in a complete and timely manner. The MSW supervisor role is that of an active advisor, consulting with the BSW on assessing the needs of patients and families, developing and updating the social work portion of the plan of care, and delivering care to patients and families. This supervision may occur in person, over the telephone, through electronic communication, or any combination thereof.
Social workers with a baccalaureate degree from a school of social work accredited by the Council on Social Work Education and who are employed by the hospice before the effective date of this final rule are exempted from the MSW supervision requirement. Therefore, if a hospice currently employs a BSW, unsupervised by an MSW, it is not required to hire an MSW to supervise the BSW. If a hospice hires a new social worker with a baccalaureate degree and one year of experience in a health care setting, then the new baccalaureate social worker must be supervised by an MSW who has one year of experience in a health care setting.
In this final rule we are incorporating changes made by a separate final rule (72 FR 66222, 66406, November 27, 2007) to the personnel qualifications for physical therapists, physical therapist assistants, occupational therapists, occupational therapist assistants, and speech-language pathologists. That final rule amended § 418.92 of the existing hospice regulations to cross reference the revised personnel requirements contained in 42 CFR 484.4, thereby requiring physical therapists, physical therapist assistants, occupational therapists, occupational therapist assistants, and speech-language pathologists subject to the requirements of the hospice conditions of participation to meet the same personnel requirements as therapists subject to the requirements of the home health agency conditions of participation. In this final rule, we continue to require therapists who are subject to the requirements of the hospice conditions of participation to meet the same personnel requirements as therapists subject to the requirements of the home health agency conditions of participation, as was required by the November 27, 2007 final rule.
We believe that these revised requirements, which went through the notice-and-comment rulemaking process separate from and more recently than the hospice conditions of participation continue to allow hospices the flexibility to employ or contract with individuals who are well qualified to provide therapy services to hospice patients. However, we are replacing the cross reference to the requirements of 42 CFR part 484 with a duplicate of the requirements of § 484.4. We believe that duplicating the relevant requirements of § 484.4 in § 418.114(b)(4)-(8) will make it easier for hospices to know the personnel requirements that their therapists must meet in order to be considered qualified to provide services to hospice patients.
We also understand that some volunteers may perceive a criminal background check as an affront. However, we believe that explaining that background checks are a precaution that everyone must take, and that background checks are not meant to single anyone out, will ease volunteer concerns and not deter them from offering their time and services to hospices.
The provisions concerning licensure requirements for hospices are currently located at § 418.72, “Condition of participation: Licensure.” We proposed to expand this condition by making a minor revision to the language at existing § 418.72(a), requiring the hospice and its staff to operate and furnish services in compliance with all Federal, State, and local laws and regulations applicable to hospices related to the health and safety of patients.
Under § 418.116(b), “Satellite locations,” we proposed to continue to require that the hospice comply with the requirements of § 420.206 regarding disclosure of ownership and control information. We also proposed that the hospice and any other satellite locations operated under the same provider number be licensed in accordance with applicable State licensure laws before the hospice could be reimbursed for Medicare services. This proposed provision would apply to the hospice as an entity, as well as to any personnel furnishing services to hospice patients. We proposed to recodify the current requirements at § 418.92(b), regarding laboratory services, at § 418.116(c).
In this final rule we are adopting the provisions as set forth in the May 27, 2005 proposed rule with the following revisions. We have—
• Deleted proposed revisions to the definition of the term “attending physician.”
• Amended the definition of “bereavement counseling” by adding the term “before and”.
• Revised the definition of “clinical note.”
• Added a definition of the term “comprehensive assessment.”
• Added a definition of the term “dietary counseling.”
• Deleted the definition of the term “drug restraint.”
• Added a definition of the term “initial assessment.”
• Amended the definition of “licensed professional.”
• Amended the name and definition of “satellite location,” now referred to as “multiple location.”
• Added a definition of the term “physician.”
• Added a definition of the term “physician designee.”
• Revised the definition of “restraint,” incorporating definitions of the terms “restraint”, “drug restraint”, and “physical restraint” into a single definition.
• Revised the definition of “seclusion.”
• Deleted the definitions of the terms “physical restraint” and “progress note.”
• Renamed 418.52(a) “Notice of rights and responsibilities.”
• Revised the phrasing of § 418.52(a)(1).
• Redesignated and revised proposed § 418.52(a)(3) to § 418.106(e)(2)(i).
• Redesignated and revised proposed § 418.52(a)(4) as § 418.52(a)(3).
• Revised § 418.52(b)(4) to clarify the hospice's responsibility for investigating and reporting violations of patient rights.
• Renamed and revised section 418.52(c) “Rights of the patient” to include several new patient rights.
• Deleted § 418.52(d) “Confidentiality of clinical records” (now at 418.52(c)) and § 418.52(e), “Patient liability.”
Revised the stem statement.
Revised § 418.54(a) to clarify the assessment timeframe.
Revised § 418.54(b) to clarify the role of the patient's attending physician, and expand the timeframe for completing the comprehensive assessment.
Revised § 418.54(c) to include new factors that must be considered during all comprehensive assessments. The new factors are functional status, imminence of death, and severity of symptoms.
Renumbered § 418.54(c)(3)(ii) as § 418.54(c)(6), and revised the title of this section as “Drug Profile.” We also revised the factors that hospices must consider in the drug profile assessment.
Revised the requirements for the “bereavement assessment” now at § 418.54(c)(7) to require that a hospice incorporate information gathered from the initial assessment into the patient's plan of care and consider such information when developing the bereavement plan of care.
Revised § 418.54(d) to require an update of the comprehensive assessment at least every 15 days. We also deleted the requirement that the comprehensive assessment be updated at the time of each recertification.
Revised the stem statement.
Revised § 418.56(a)(1) to maintain consistent terminology throughout the rule. In addition, we retained the existing hospice rule provision that requires the hospice to designate a registered nurse that is a member of the IDG to coordinate patient care, assessment, and care plan implementation.
Revised the IDG requirements at § 418.56(a)(1)(i) to require that the physician member of the IDG be an employee of or under contract with the hospice. We also revised § 418.56 (a)(1)(iv), to retain the existing hospice requirement that the hospice IDG must include a pastoral or other counselor.
Revised § 418.56(a)(2) regarding the members of the IDG responsible for developing day-to-day hospice policies and procedures.
Revised § 418.56(b) to clarify that a patient's plan of care must be individualized to his or her needs and circumstances. Additionally, we revised this section to require a hospice to involve the patient and primary caregiver in developing the plan of care in accordance with the patient's needs. We also clarified which individuals must be educated and trained by the hospice in implementing the plan of care, as well as the extent of that education and training.
Revised § 418.56(c) to specify that the written plan of care must be individualized. We also added a provision that the plan of care must reflect patient and family goals.
Revised § 418.56(c)(1) to simplify the phrasing of the requirement.
Removed the term “targeted” from § 418.56(c)(3) to simplify its phrasing.
Revised § 418.56(c)(6) by changing “family” to “representative.”
Revised § 418.56(d). We removed specific mention of the role of the hospice medical director or physician designee in updating each patient's plan of care. We also revised the timeframes for updating the plan of care to at least every 15 days. Additionally, we added a requirement that the IDG must note the patient's progress toward specified goals when updating in the plan of care.
Made several minor revisions to § 418.56(e) that do not change the intent of the proposed and added a new requirement that hospice coordination and communication systems must ensure that information is shared with non-hospice health care providers furnishing services to patient.
Removed the phrase “focuses on the end-of-life support services provided” from § 418.58.
Replaced the phrase “end-of-life support services” with “hospice service” in § 418.58(a). In addition, we replaced the phrase “for which there is evidence that improvement in those indicators will improve palliative outcomes” with the phrase “related to improved palliative outcomes.”
Revised § 418.58(b) to clarify our intent. In § 418.58(b)(2)(ii), we incorporated a requirement that quality indicator data must be used to identify priorities, as well as opportunities, for improvement. In § 418.58(b)(3), we replaced the term “specified” with the term “approved” to clarify that the governing body is not necessarily the entity that establishes data collection specifications.
Added a 240-day phase-in period to § 418.58(d) to allow hospices more time to collect the initial program data.
Revised § 418.58(e) by adding a requirement that the governing body annually evaluates the hospice's QAPI program. We also added a requirement that the hospice governing body must identify at least one individual who is responsible for operating the QAPI program. Deleted proposed § 418.58(e)(3) regarding expectations for patient safety.
Expanded the scope of the hospice's infection control program to protect visitors as well as patients, families and hospice personnel.
Replaced the term “staff” in proposed § 418.60(c) with the terms “employees” and “contracted providers.”
Revised § 418.62(b) to clarify that licensed professionals providing care to hospice patients must actively participate in the coordination of all aspects of the patient's hospice care.
Revised § 418.64 to permit hospices to utilize contracted staffing sources under extraordinary or other non-routine circumstances (for example, unanticipated periods of peak patient loads, short-term staffing shortages that interrupt patient care, and patient travel). Deleted the proposed requirement at § 418.64(a) that hospice physicians be responsible for meeting a patient's general (that is, non-hospice) medical needs.
Replaced the term “nurse practitioner” with “registered nurse” in § 418.64(b)(2). We also deleted the proposed requirement at § 418.64(b)(2) that the role and scope of nurse practitioner services be separately specified in the plan of care.
Revised the requirements in § 418.64(d) to clarify the role of counseling services, requiring that hospices make available counseling services, “* * * to assist the patient and family in minimizing the stress and problems that arise from the terminal illness, related conditions, and the dying process.”
Revised § 418.64(d)(1)(i) to permit individuals with education (as well as experience) in grief/loss counseling to supervise a hospice's bereavement
Revised § 418.64(d)(2), renaming it “Dietary counseling,” to be more consistent with the terminology used throughout the rest of the rule.
Revised section 418.64(d)(3)(iii) by removing the statement that hospices are not required to go to extraordinary lengths to facilitate clergy, pastoral, or other visits from this section. We added language that indicates that hospices must make all reasonable efforts to facilitate such visits.
Removed the requirement at proposed § 418.66(d) that CMS may approve a maximum of two 1-year extensions for each initial waiver.
Revised § 418.74(d) by removing the requirement at 418.66(d) that CMS may approve a maximum of two 1-year extensions for each initial waiver.
Revised § 418.76 by changing its name from “Home health aide and homemaker services” to “Hospice aide and homemaker services.”
Revised § 418.76(a)(ii) to clarify that the evaluation program used to measure aide competency must meet the specific requirements of § 418.76(c) of this section. Clarified that the training or competency evaluation programs referred to in § 418.76(a)(2) are those programs described in § 418.76(a)(1).
Added an option in § 418.76(a)(1), that a hospice aide may be considered qualified if the aide has completed a training and competency evaluation program in accordance with the content and specifications of the nurse aide training program requirements for long term care facilities at 42 CFR part 483.
Revised the language in § 418.76(b)(1) to describe the training that hospice aides must complete. The revised requirement states that, “[h]ospice aide training must include classroom and supervised practical training.”
Revised § 418.76(c)(1) to clarify that a competency evaluation program is required to address the areas identified in § 418.76(b)(3) of this section, rather than the requirements of § 418.76(b)(1) through § 418.76(b)(3). Revised the requirement in § 418.76(c)(4) to specify that an aide is not considered to have successfully completed a competency evaluation if the aide has an “unsatisfactory” rating in more than one required area.
Deleted the proposed requirement in § 418.76(d) that an organization excluded by § 418.76(f) would be excluded from offering in-service training to hospice aides. This paragraph continues to exclude certain organizations from initially training hospice aides.
Revised § 418.76(e) to clarify that the requirements of this section apply to instructors providing both classroom and supervised practical training. We are no longer applying the requirements of this standard to those individuals performing competency evaluations or in-service trainings. Third, we clarified the description of the training instructor by rearranging the language and clarifying that one year of the trainer's health care experience would be in the broad home care environment (that is, hospice or home health care), rather than in the more specific home health care environment.
Revised § 418.76(f) to state that any home health agency that, within the last two years, was out of compliance with the requirements of paragraphs § 418.76(b) or § 418.76(c) of this section was not eligible to train hospice aides, except with respect to in-service training.
Deleted the proposed language in 418.76(g)(1) that an appropriate qualified therapist may make hospice aide assignments or supervise hospice aides. Also in section 418.76(g)(1), we added a new specification requiring the nurse who makes aide assignments for a specific aide and patient to be a member of that patient's hospice IDG.
Revised § 418.76(g)(2) to indicate that the hospice IDG as a whole may order aide services.
Revised § 418.76(h) by removing references to qualified therapists.
Clarified the purpose of the every 14 day aide supervision visit in § 418.76(h)(1)(i).
Added a provision in § 418.76(h)(1)(ii) stating that if during the supervision visit the nurse supervisor notes a potential area of concern regarding the way in which hospice aide services are being furnished, then the supervising registered nurse must make an on-site visit to the patient when the hospice aide is present, to observe and assess the aide while he or she is performing care.
Added § 418.76(h)(1)(iii) to clarify these problems identified during any hospice aide supervisory visits that cannot be resolved at that time by the supervising registered nurse, the hospice aide must complete a competency evaluation in accordance with § 418.76(c). We also redesignated § 418.76(h)(2) as § 418.76(h)(3). We added a new section 418.76(h)(2) to require a hospice registered nurse to make an annual on-site visit to observe each hospice aide furnishing aide services to at least one patient. Hospices may determine the appropriate location to document this annual aide evaluation in accordance with their own policies and procedures.
Deleted proposed 418.76(h)(3).
Added a provision in § 418.76(i)(2) that the individuals providing Medicaid personal care aide services may only be used by the hospice in implementing a patient's plan of care to the same extent that the hospice would routinely use a patient's family in implementing the plan of care.
Added a provision in § 418.76(i)(3) that a hospice must coordinate its hospice aide and homemaker services with the personal care aide services provided by Medicaid to ensure that patient needs are met.
Reorganized § 418.76(j) to clarify that homemakers must either meet the standards of § 418.202(g) (in 42 CFR 418 Subpart F Covered Services) and complete hospice orientation, or meet the requirements for hospice aides at § 418.76 as indicated in revised § 418.76(j)(2). There are no substantive changes to this paragraph.
Revised the qualifications for the supervision of homemakers in § 418.76(k) to require that such services be supervised by the same member of the IDG who coordinates the services.
Revised the requirements of § 418.100(a) and § 418.100 (a)(1) to make clear that hospices must structure their operations to fully serve patients and families at the end of life.
Clarified then relationship between a hospice's governing body and administrator in § 418.100(b) by adding a provision that the administrator must be appointed by the governing body.
Revised the requirement in § 418.100(e) to state that hospices must maintain oversight responsibility for services furnished under contract.
Revised the requirement in § 418.100(e)(2) that contracted services
Revised and reorganized § 418.100(f) by replacing the term “satellite location” with the term “multiple location,” and adding new requirements for Medicare approval.
Revised § 418.100(g) by adding (g)(1) and (2) to address the orientation of patient care employees in the hospice philosophy and the initial orientation of a hospice employee to his or her specific job duties. We also redesignated proposed paragraph (g) as (g)(3).
Revised § 418.102 by describing the employment relationship between the medical director and the hospice. We clarified that the medical director is either an employee of the hospice (paid or volunteer) or is an individual under contract with the hospice. We also revised the requirement to state that the hospice is responsible for designating the individual who fulfills the physician designee role in the medical director's absence.
Inserted a new § 418.102(a) to address contracting for medical director services, and redesignated the other paragraphs accordingly. The new paragraph specifies that hospices may choose to make arrangements for medical director services to be met through a contract with a self-employed doctor or through a contract with a professional entity or physicians group. Revised § 418.102 (a)(2) specifies that if a hospice chooses to contract with a professional entity or physicians group for medical director services, the contract must identify a particular physician who will fulfill the hospice medical director's role and responsibilities.
Redesignated § 418.102(a) as § 418.102(b) and revised it to delete the term “criteria.”
Deleted proposed § 418.102(b)(2), which would have required the medical director to review the patient's and family's expectations and wishes for the continuation of hospice care at the time of each recertification.
Redesignated and revised § 418.102(c) as § 418.102(d). The revision requires the hospice medical director to assume responsibility for the medical component of the hospice's patient care program. We deleted references to the joint responsibility of the IDG.
Revised § 418.104(a) to clarify which documents must be included in the clinical record.
Revised § 418.104(a) to specify that all versions of the plan of care (initial and updated) must be in the clinical record. Likewise, we clarified that all assessments (initial, comprehensive, and updated comprehensive) must be included in the patient's clinical record. In addition, we removed the language that separate progress notes must be included in the clinical record because all notes, including notes that document a patient's progress, are included under the broad heading of “clinical notes.” Furthermore, we removed the requirement that the clinical record must contain a patient's informed consent from this section. In its place, we require that the clinical record contain a copy of the notice of patient rights (in accordance with § 418.52(a)(3)), which requires a hospice to obtain the patient's or representative's signature confirming that he or she has received a copy of the notice of rights. Deleted the requirement in section § 418.104(b) that, “[a]ll entries must be signed, and the hospice must be able to authenticate each handwritten and electronic signature of a primary author who has reviewed and approved the entry.” We are requiring authentication and dating in accordance with hospice policy and accepted standards of practice.
Revised § 418.104(d) to specify the length of time that a hospice is required to retain a patient's clinical record after death or discharge from five years to six years in accordance with the HIPAA requirements.
Revised § 418.104(e) by replacing the term “Medicare/Medicaid-approved facility” with “Medicare/Medicaid-certified facility.”
Revised § 418.104(e)(1) and (2) by requiring only that the discharge summary be sent to the receiving facility/physician, and that the clinical record be made available only upon request.
Revised this CoP by combining the requirements of proposed § 418.106 and proposed § 418.110(m) and § 418.110(n).
Revised § 418.106(a) to now require the hospice to ensure that the IDG confers with a qualified individual with education and training in drug management who is an employee of, or under contract with, the hospice to ensure that drugs and biologicals meet each patient's needs. This section also requires a hospice that provides inpatient care directly in its own facility to provide pharmacy services under the direction of a qualified licensed pharmacist who is an employee of, or under contract with, the hospice. Incorporated the proposed requirements of § 418.110(n) in section 418.106(b). Drug orders must only be given by a physician or nurse practitioner. If a drug order is given verbally or electronically, it must be given to a licensed nurse, nurse practitioner, pharmacist, or physician, and must be recorded and signed immediately by the receiver. The prescribing individual must sign the order in accordance with State and Federal regulations.
Inserted new section 418.106(c), “Dispensing of drugs and biologicals,” to incorporate elements of proposed § 418.110(m) and (n). This new standard requires a hospice to have a written policy to promote dispensing accuracy, maintain current and accurate records of the receipt and disposition of all controlled drugs, and obtain drugs and biologicals from community or institutional pharmacists or its own stock. Some of these requirements (that is, policy for dispensing accuracy and controlled drug records) only apply to those hospices that choose to maintain their own drug and biological stocks.
Revised § 418.106(d) to combine proposed standards § 418.106(a)(2) and § 418.110(n)(2). Revised § 418.106(d) is divided into two elements, one for patients receiving care in their home and another for patients receiving care in a hospice inpatient facility. If a patient is receiving care in his or her home, the hospice IDG must determine the patient's and/or family's ability to safely administer drugs and biologicals in the home. If a patient is receiving care in an inpatient facility operated by the hospice, then drugs may only be administered to the patient by a designated list of individuals working in the inpatient facility.
Revised § 418.106(e) to combine and revise the requirements of § 418.106(b) and § 418.110(n)(3), § 418.110(n)(4), and § 418.110(n)(5). A hospice must ensure that all drugs and biologicals are labeled with appropriate use and cautionary instructions, as well as an expiration date, in accordance with accepted standards of practice. In addition, a hospice must have written policies and procedures for the management and disposal of controlled drugs in a patient's home, and must provide and discuss them with the patient and family at the time when controlled drugs are initially ordered. Furthermore,
Revised § 418.106(f) to clarify the hospice's responsibility for durable medical equipment and medical supplies and the hospice's contractual relationship with a durable medical equipment supplier. Specifically, section 418.106(f)(1) and (2) have been revised to state that, regardless of whether the hospice provides durable medical equipment and medical supplies directly or under contract, the hospice must ensure the following: That manufacturer recommendations for routine and preventive maintenance are followed; that maintenance policies are developed when no manufacturer recommendations exist; that equipment is safe; that equipment works as intended; that patients, families, and other caregivers receive instruction in the safe use of equipment and supplies; and that patients, families, and other caregivers are able to demonstrate the safe and appropriate use of equipment and supplies.
Added § 418.106(f)(3) to state that, if a hospice chooses to contract with an entity for durable medical equipment, it may only contract with a durable medical equipment supplier that meets the Medicare Supplier Quality and Accreditation Standards at 42 CFR 424.57.
Revised 418.108(b)(2) to require a facility providing only the respite level of care to meet the 24-hour nursing needs of all patients in accordance with each patient's plan of care. A facility providing only the respite level of care is not required to automatically have registered nurse present on all shifts to provide direct patient care.
Revised the opening paragraph of this CoP to clarify that the requirements of § 418.110 apply only to those inpatient facilities operated by a hospice. Where a hospice has its “own inpatient facility,” either in a freestanding building or as a section located in the building of another provider type, the requirements of § 418.110 apply to the building or applicable portion thereof as if it were physically located with the hospice administrative offices, as well as to the hospice patients receiving care within that building.
Added a requirement at § 418.110(b)(2), originally at § 418.100(a) of the existing hospice regulations, that at least one registered nurse must provide direct patient care on each shift. However, unlike the current § 418.100(a), this requirement only applies if the hospice inpatient facility is providing general inpatient care to one or more patients.
Removed the proposed requirements § 418.110(c)(1)(i) and (ii), that a hospice must report safety breaches and that hospices must prevent, report, and correct equipment failures.
Deleted § 418.110(d)(4) and § 418.110(d)(5), the phase-in provisions requiring hospices to comply with certain emergency lighting and door latching requirements as of March 13, 2006.
Redesignated proposed paragraph § 418.110(d)(6) as paragraph § 418.110(d)(4).
Added an exception to § 418.110(f)(1)(iv) with respect to the number of patients that may occupy a single room. Redesignated proposed § 418.110(o) as § 418.110(m), and revised it to correspond with the seclusion and restraint requirements for hospitals.
Revised proposed § 418.110(o)(6) as § 418.110(n) to provide more detailed guidance regarding the role of staff training in safely and successfully implementing restraint or seclusion techniques. These changes conform to the requirements of the hospital conditions of participation.
Redesignated proposed § 418.110(o)(7) as § 418.110(o) to provide more detailed requirements regarding death reporting requirements.
Deleted the term “other facilities” throughout this section.
Revised § 418.112(b) to clarify a hospice's responsibility for care furnished to hospice patients who reside in a SNF/NF or ICF/MR. A hospice assumes all responsibility for the professional management of all hospice services furnished to residents, including hospice-related inpatient care. All services furnished by the hospice must be in accordance with the individualized plans of care.
Deleted § 418.112 (c) and (d), and redesignated the remaining sections accordingly.
Redesignated § 418.112(e) as § 418.112(c), deleted some provisions, clarified other provisions, and incorporated new provisions regarding the written agreement between a hospice and a SNF/NF or ICF/MR.
Redesignated § 418.112(f) as § 418.112(d) and replaced some of the detailed plan of care requirements included in the proposed standard with a cross reference to the requirements of § 418.56. We also clarified that the hospice must discuss changes in a patient's plan of care with the patient or the patient's representative, as well as with representatives of the SNF/NF or ICF/MR where the patient resides.
Revised § 418.112(g) (redesignated as § 418.112(e)) to clarify the hospice's patient care coordination responsibility.
Deleted proposed § 418.112(h).
Revised § 418.112(i) and redesignated it as § 418.112(f) to clarify that a hospice is not required to provide orientation training itself if another hospice has already done so.
Revised § 418.114(a) by combining the requirements of proposed standards § 418.114(a) and § 418.116(a). The revised § 418.114 requires that all professionals who furnish hospice services be currently licensed, certified or registered to provide services in accordance with applicable Federal, State, and local laws. Furthermore, all professionals must act only within the scope of their license, certification, or registration.
Revised § 418.114(b) by replacing the proposed term “home health aides” with the final term “hospice aides.” We also added revised personnel requirements for social workers at § 418.114(b)(3).
Revised personnel requirements for physical therapists, physical therapy assistants, occupational therapists, occupational therapy assistants, and speech-language pathologists to incorporate changes made to these sections in a separate final rule (72 FR 66222, November 27, 2007) Revised § 418.114(d) to provide more specificity
Moved proposed § 418.116(a) to a similar provision at final § 418.114(a).
Replaced the term “satellite locations” with the term “multiple locations” in final § 418.116(a) (proposed § 418.116(b)) to conform to other sections of the final rule.
Under the Paperwork Reduction Act of 1995, we are required to provide 30-day notice in the
The need for the information collection and its usefulness in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection burden.
The quality, utility, and clarity of the information to be collected.
Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.
Therefore, we are soliciting public comment on each of these issues for the following sections of this document that contain information collection requirements.
Section 418.52(a)(1) states that a hospice must provide the patient or representative with verbal and written notice of the patient's right and responsibilities. The notification must be presented in a manner and language consistent with the patient's ability to comprehend the information. Section 418.52(a)(2) requires a hospice to inform and distribute written information on its policies concerning advance directives. The information must include a description of applicable State laws. Section 418.52(a)(3) states that a hospice must obtain the patient's or representative's signature confirming that he or she has received a copy of the notice of rights.
The burden associated with the notification requirements contained in § 418.52(a) is the time and effort necessary for a hospice to: develop the notification form; provide, both verbally and in writing, the patient or the patient's representative with a notice of patient's rights; inform and distribute information pertaining to its policies on advance directives and applicable State laws; obtain signatures from either the patient or representative confirming receipt of a copy of the notice of rights. There are 2,872 hospices that must comply with the aforementioned requirements. We estimate that it will take each hospice 8 hours to develop the form and 5 minutes to meet the requirements in § 418.52(a)(1-3). We estimate that each hospice will on average provide 303 notifications per year for a total one time burden of 22,976 hours and annual burden of 72,518 hours.
Section 418.52(b) sets out the right of the patients to exercise these patient rights and requires hospices to show respect for property and person. Specifically, § 418.52(b)(4)(i) states that a hospice is accountable for ensuring
The burden associated with the recordkeeping and reporting requirements described in § 418.52(b) is the time and effort necessary to report all alleged violations to the hospice administrator, to conduct and document an investigation and to maintain record of the documented investigation. There is also burden associated with reporting all verified allegations to the State and local bodies that have jurisdiction. We anticipate that each of the 2,872 hospices will investigate, document, and report 15 violations per year. We estimate that it will take each hospice 60 minutes per event to satisfy the requirements contained in § 418.52(b). The estimated annual burden associated with the requirements contained in § 418.52(b) is 43,080 hours.
Section 418.54 contains the information collection requirements associated with the initial and comprehensive assessment of the patient. Section 418.54(a) requires a hospice to conduct the initial patient assessment within 48 hours after the patient or representative elects the hospice benefit. Section 418.54(b) states that the hospice IDG must complete the patient's comprehensive assessment no later than 5 calendar days after the patient or representative elects the hospice benefit. Section 418.54(c) sets out the content of the assessment. Section 418.54(d) requires that the comprehensive patient assessment be updated as needed based on the patient's condition, but no less frequently than every 15 days.
The burden associated with the requirements in § 418.54 is the time and effort necessary to document and maintain the patient assessment. While these requirements are subject to the PRA, the associated burden is exempt as stated in 5 CFR 1320.3(b)(2); conducting patient assessments is a usual and customary business practice. The time, effort, and financial resources necessary to comply with a collection of information that would be incurred by a person in the normal course of their activities are considered to be usual and customary and is exempt from the PRA.
Section 418.56(a) requires a hospice that has more than one IDG to designate a group to establish policies governing the day-to-day provision of hospice care and services. The burden associated with this requirement is the time and effort necessary to draft, implement, and maintain the policies governing the day-to-day provision of hospice care services. While this requirement is subject to the PRA, the burden is considered to be usual and customary and is exempt as stated under 5 CFR 1320.3(b)(2).
Section 418.56(b) requires all hospice care and services furnished to patients and their families to follow an established plan of care established by the hospice IDG and the patient's caregivers. In addition, a hospice must ensure that each patient and the primary caregiver(s) receive education and training provided by the hospice. The education and training must be specific to the individual's responsibilities with respect to the care and services outlined in the plan of care. The burden associated with this requirement is the time and effort associated with educating and training the patient and patient caregiver(s). This requirement is currently approved under OMB control number 0938-0302. The expiration date for the approval is August 31, 2009.
Section 418.56(c) requires hospices to develop an individualized written plan of care for each patient. The plan of care must contain the information described in § 418.56(c)(1)-(6). Section 418.56(d) states that the hospice interdisciplinary team must review, revise, and document the individualized plan of care as frequently as the patient's condition warrants, but no less frequently than every 15 days. The burden associated with these requirements is the time and effort associated with drafting, reviewing, revising, and maintaining the plan of care. This requirement is currently approved under OMB control number 0938-0302, with an expiration date of August 31, 2009.
Section 418.56(e) describes the standard for the coordination of hospice services. Specifically, it states that a hospice must develop and maintain a system of communication and integration to ensure the information contained in § 418.56(e)(1)-(5). The burden associated with this requirement is the time and effort required to develop and maintain the system of communication in accordance with the hospice's policies and procedures. While this requirement is subject to the PRA, the associated burden is considered to be usual and customary as stated in 5 CFR 1320.3(b)(2).
Section 418.58 states that a hospice must develop, implement, and maintain an effective, ongoing, hospice-wide data-driven quality assessment and performance improvement (QAPI) program. In addition, the hospice must maintain documentary evidence of its quality assessment and performance improvement program and be able to demonstrate its operation to CMS. Section 418.58(a) describes the required scope of the QAPI program. Specifically, § 418.58(a)(1) discusses the documentation requirements. The QAPI program must be able to demonstrate measurable improvement in indicators related to improved palliative outcomes and hospice services. Section 418.58(a)(2) states that the hospice must measure, analyze, and track quality indicators.
Section 418.58(b)(2) states that a hospice must use the data to monitor the effectiveness and safety of services and quality of care. As part of the monitoring process, the data must be used to identify improvement opportunities. The data must also be used to assist in the prioritization of the aforementioned opportunities for improvement.
Section 418.58(c)(2) states that as part of performance improvement activities, a hospice must track adverse patient events, analyze their causes, and implement preventative actions and mechanisms that include feedback and learning throughout the hospice. Section 418.58(c)(3) requires a hospice to measure its success and track performance in its performance improvement initiatives to ensure that the improvements are continuous.
Section 418.58(d) discusses that standard for performance improvement projects. Hospices are responsible for developing, implementing, and evaluating performance improvement projects. Section 418.58(d)(2) requires
The burden associated with the requirements contained in § 418.58 is the time and effort necessary to develop, draft, and implement a QAPI program. As part of the QAPI program, there is also burden associated with recording quality data for performance improvement initiatives. We estimate that for all 2,872 hospices, 1 hour per hospice will be required to comply with the documentation of the domains and measures, 91 hours per hospice for data entry and 48 hours to aggregate the data. This is an annual burden of 140 hours per hospice to meet the requirement of this section. The estimated annual burden associated with the requirements in § 418.58 is 402,080 hours annually.
Section 418.60(a) requires hospices to maintain and document an effective infection control program. The goal of the program is to protect patients, families, visitors, and hospice staff by preventing and controlling infectious and communicable diseases. Section 418.60(b) provides the standard for effective hospice infection control programs. Section 418.60(c) describes the standard for education with respect to infection control. Hospices must provide infection control education to employees, contracted providers, patients, and family members and other care givers.
The burden associated with the requirements in § 418.60(a)-(c) is the time and effort associated with developing, implementing, documenting, and maintaining an effective infection control program. There is also burden associated with providing infection control education. While these requirements are subject to the PRA, the burden is exempt as stated in 5 CFR 1320.3(b)(2). The existence of an effective infection control program is a usual and customary business practice in the hospice care industry.
Section 418.64 states that hospices may contract for the physician services contained in § 418.64(a). A hospice may also enter into a written agreement with another Medicare-certified hospice program for the provision of the core services. The burden associated with these requirements is the time and effort necessary to develop, draft, sign, and maintain contracts and written agreements. The burden associated with these requirements is exempt from the PRA as stated in 5 CFR 1320.3(b)(2); the use of contracted physicians and the use of written agreements between two Medicare certified hospice programs for the provision of core services constitutes a usual and customary business practice.
Section 418.64(d) describes the standard for counseling services. Hospices are required to make counseling services available to patients and families to provide comfort and assistance with coping and stress management associated with the dying process. Specifically, section § 418.64(d)(1)(iv) states that as part of bereavement counseling, a hospice must develop a bereavement plan of care that notes the kind of bereavement services to be offered and the frequency of service delivery. Section 418.64(d)(3) states that a hospice must provide an assessment of the patient's and family's spiritual needs, provide spiritual counseling to meet those needs in a manner that is accepted by the patient and family and is consistent with their respective beliefs, facilitate visits by individuals that can meet the patient's spiritual needs, and advise the patient and family of the availability of the aforementioned bereavement counseling services. We believe the requirements in § 418.64(d) are usual and customary business practices; and therefore, the burden is not subject to the PRA as stipulated in 5 CFR 1320.3(b)(2).
Section 418.66(a) allows CMS to waive the requirement in § 418.64(b) that a hospice provide nursing services directly, if the hospice is located in a nonurbanized area. To obtain a waiver, the hospice must provide evidence to CMS that it made good faith efforts to hire a sufficient number of nurses to provide services. As part of CMS’ review process, the hospice must meet the criteria outlined in § 418.66(a)(1)-(3). To obtain an extension for a currently approved waiver, a hospice must submit its request to CMS prior to the expiration of the waiver period and certify that the conditions under which the hospice originally requested the waiver have not changed. The burden associated with this requirement is the time and effort associated with a hospice demonstrating good faith efforts for its staffing process and submitting a certified extension request to CMS stating that the circumstances that caused the original waiver request have not changed. We believe this requirement and the associated burden is exempt from the PRA under 5 CFR 1320.3(c)(4). We believe the requirement will affect less than 10 entities on an annual basis.
Section 418.74(a) allows CMS to waive the requirement for providing physical therapy, occupational therapy, speech-language pathology, and dietary counseling services (as needed) on a 24-hour basis for hospices located in non-urbanized areas. In addition, CMS can waive the requirement that a hospice provide dietary counseling directly. To obtain a waiver, a hospice must provide evidence to CMS that it made good faith efforts to meet the requirements for the aforementioned services prior to submitting a waiver request. As part of CMS’ review process, a hospice's waiver request must meet the criteria outlined in § 418.74(a)(1)-(2). To obtain an extension for a currently approved waiver as stated in § 418.74(d), a hospice must submit its request to CMS prior to the expiration of the waiver period and certify that the conditions under which the hospice originally requested the waiver have not changed. The burden associated with this requirement is the time and effort associated with a hospice demonstrating good faith efforts for its staffing process and submitting a certified extension request to CMS stating that the circumstances that caused the original waiver request have not changed. We believe this requirement and the associated burden is exempt from the PRA under 5 CFR 1320.3(c)(4). We believe the requirement will affect less than 10 entities on an annual basis.
Section 418.76(b) outlines the standard for the content and duration of hospice aide classroom and supervised practical training. A hospice aide training program must meet the criteria in § 418.76(b)(1)-(3). Section 418.76(b)(4) requires that a hospice maintain documentation demonstrating that its training program meets the requirement of the standard contained in § 418.76(b). We estimate that it will take each hospice 5 minutes to document and maintain records that its hospice aide training program met all of the requirements contained in this
Section 418.76(c) describes the standard for competency evaluations. In particular, § 418.76(c)(5) states that a hospice must maintain documentation that all individuals furnishing hospice aide services on behalf of a hospice successfully completed a competency evaluation program. The competency evaluation program must meet the requirements specified under § 418.76(b)(3). The burden associated with this requirement is the time and effort necessary to maintain documentation that demonstrates all individuals furnishing hospice aide services on behalf of a hospice successfully completed a competency evaluation program. We estimate it will take each hospice 5 minutes to meet this requirement, for a total annual burden of 239 hours.
Section 418.76(d) discusses the standard for in-service training. Hospices are required to maintain documentation that all hospice aides have received at least 12 hours of in-service training during each 12-month period. The burden associated with this requirement is the time and effort necessary to document and maintain record of the required in-service training. We estimate it will take each hospice 2 hours annually to meet this requirement. The estimate total annual burden for this requirement is 5,744 hours.
Section 418.76(g) describes the standard for hospice aide assignments and duties. Specifically, § 418.76(g)(1) states that written patient care instructions for a hospice aide must be drafted by a registered nurse responsible for the supervision of a hospice aide. The burden associated with this requirement is the time and effort necessary for a registered nurse responsible for supervising a hospice aide to draft written patient care instructions for the hospice aide. We believe this is a usual and customary business practice and is thereby exempt from the PRA under 5 CFR 1320.3(b)(2).
Section 418.76(h) explains the standard for the supervision of hospice aides. In particular, § 418.76(h)(1)(i) stated that a registered nurse must make an onsite visit to a patient's home no less frequently than every 14 days to assess and document the quality of care and services provided by the hospice care aide and to ensure that the services ordered by the hospice's IDG meet the patient's needs. The burden associated with this requirement is the time and effort necessary for a nurse to conduct an onsite evaluation of a hospice care aide in the patient's home, to document the quality of care provided by the hospice care aide, and to evaluate the services ordered by the IDG to ensure that they are consistent with the patient's needs. We believe this is a usual and customary business practice and is thereby exempt from the PRA under 5 CFR 1320.3(b)(2).
Section 418.76(h)(2) states that a registered nurse must also make an annual onsite visit to the location to the location where a patient is receiving care to observe and evaluate each aide while he or she is performing care. Section 418.76(h)(3) details the contents of the registered nurse's assessment required in 418.76(h)(3). The burden associated with this requirement is the time and effort necessary for a registered nurse to make an annual on site visit to observe and evaluate each hospice aide while they perform care. In addition, they must document the evaluation. We estimate to meet this requirement that 5 supervisory visits will be conducted on an annual basis per hospice with a total of 14,360 visits annually. We believe it will take each nurse 5 minutes to document the onsite visit. The estimated total annual burden associated with this requirement is 1,197 hours.
Section 418.76(i)(1) contains the standard for individuals furnishing Medicaid personal care aide-only services under a Medicaid personal care benefit. Prior to furnishing personal care services, an individual must demonstrate competency in the services they are required to furnish. The burden associated with this requirement is the time and effort necessary to demonstrate competency. While this requirement is subject to the PRA, we believe the associated burden is exempt stated in 5 CFR 1320.3(b)(2). We believe this is a usual and customary business practice.
Section 418.76(k)(2) requires the instructions for homemaker duties to be prepared by a member of the hospice IDG. The burden associated with this requirement is the time and effort necessary for a member of the IDG to develop and draft instructions for homemaker duties. We believe this is a usual and customary business practice and is thereby exempt from the PRA under 5 CFR 1320.3(b)(2).
Section 418.76(k)(3) states that homemakers must report all concerns about the patient or family to the member of the IDG who is coordinating the homemaker's services. The burden associated with this requirement is the time and effort needed for the homemaker to report all concerns. We believe the burden is exempt as stated in 5 CFR 1320.3(b)(2); this is a usual and customary business practice.
Section 418.78(a) states that a hospice must document, maintain, and provide volunteer orientation and training that is consistent with hospice industry standards. We estimate on average that a hospice would provide orientation and training six times per year; we estimate that it will take no longer than five minutes to document each orientation section for a total of 30 minutes per year per hospice. The total annual burden associated with this requirement is 1,436 hours.
Section 418.78(c) requires hospices to document and demonstrate viable and ongoing efforts to recruit and retain volunteers. The burden associated with this requirement is the time and effort necessary to document and demonstrate the recruitment and retention efforts. We estimate that it will take each hospice 3 hours to document and demonstrate its recruitment and retention efforts, for a total annual burden of 8,616 hours.
The cost-saving standard in § 418.78(d) requires hospices to document the cost savings achieved through the use of volunteers. We estimate that complying with this requirement will take 3 hours per hospice per year, or 8,616 annual hours.
Section 418.78(e) requires hospices to document and maintain records on the use of volunteers for patient care and administrative services, including the type of services and time worked. The burden associated with this requirement is the time and effort necessary to document and maintain the volunteer records. We estimate that recording these examples would take approximately 600 hours per hospice for a total annual burden of 1,723,200 hours.
Section 418.100(e) describes the standard for professional management responsibilities. A hospice that has a written agreement with another agency, individual, or organization to furnish any services under arrangement, must retain administrative and financial management, and oversight of staff and services for all arranged services, to ensure the provision of quality care. The burden associated with this requirement is the time and effort necessary to develop, draft, execute and maintain the written agreements. We believe these written agreements are part of the usual and customary business practices of
Section 418.100(f)(2) states that a hospice must continually monitor and manage all services provided at all of its locations. The burden associated with this requirement is the time and effort necessary to monitor and manage all of the services provided at all of its locations. The burdens associated with this requirement is considered to be usual and customary as stated in 5 CFR 1320.3(b)(2) and is thereby exempt from the PRA.
Section 418.100(g) describes the standard for training. In particular, § 418.100(g)(2) requires a hospice to provide an initial orientation for each employee that addresses the employee's specific job duties. Section 418.100(g)(3) requires a hospice to have written policies and procedures describing its method(s) of assessment of competency. In addition, the hospice must maintain a written description of the in-service training provided during the previous 12 months. The burden associated with the requirements of this section is considered to be usual and customary under 5 CFR 1320.3(b)(2); usual and customary burdens are exempt from the PRA.
Section 418.102(b) requires hospice medical directors or physician designees to review the clinical information for each hospice patient and provide written certification that it is anticipated that the patient's life expectancy is 6 months or less if the illness runs its normal course. Prior to making a certification statement, the medical director or physician designee must consider the issues discussed in § 418.102(b)(1)-(5). Section 418.102(c) states that before the recertification period for each patient, as described in § 418.21(a), the medical director or physician designee must review the patient's clinical information.
The burden associated with the requirements contained in § 418.102(b)-(c) is the time and effort necessary to review the written certification. We estimate this process requires 10 minutes per patient. We estimate the burden for each hospice to be 50 hours annually. The total annual burden associated with the requirements of this section is 143,600 hours.
Section 418.104 requires a hospice to maintain a clinical record for each patient. The required contents of the record are listed in § 418.104(a). The burden associated with the requirement is the time and effort necessary to document and maintain the information listed in § 418.104(a). The maintenance of clinical records is a usual and customary business practice; the burden associated with maintaining a clinical record is exempt form the PRA under 5 CFR 1320.3(b)(2).
Section 418.104(b) requires that all of the entries in a clinical record be authenticated. The entries must be legible, clear, complete, and consistent with hospice policy. The burden associated with this requirement is considered to be usual and customary under 5 CFR 1320.3(b)(2). This usual and customary burden is therefore exempt from the PRA.
Section 418.104(d) describes the standard for the retention of records. Clinical records must be retained for 6 years after the death or discharge of the patient, unless State law stipulates a longer period of time. If the hospice discontinues operation, hospice policies must provide for retention and storage of clinical records. The burden associated with these requirements is the time and effort necessary to maintain records for 6 years after the death or discharge of the patient, and to draft, implement, and maintain the record retention policy in the event that the HHA discontinues operation. While this requirement is subject to the PRA, we believe the associated burden is exempt as stated in 5 CFR 1320.3(b)(2). The development and maintenance of a record retention policy is a usual and customary business practice.
Section 418.104(f) describes the standard for the retrieval of clinical records. Clinical records, whether in hard copy or electronic form, must be made readily available on request by an appropriate authority. The burden associated with this requirement is the time and effort required to disclose a clinical record to an appropriate authority. While this requirement is subject to the PRA, we believe the associated burden is exempt as stated in 5 CFR 1320.3(b)(2). Making clinical records available to the appropriate authority is part of the survey and certification process and imposes no additional burden as a usual and customary business practice.
Section 418.106(b) describes the standard for the ordering of drugs. In particular, § 418.106(b)(2)(ii) states that the individual receiving a drug order must record and sign it immediately and have the prescribing person sign it in accordance with State and Federal regulations. The burden associated with this requirement is the time and effort necessary for the recipient of the order record and sign the order and to have the prescribing person sign the prescription. The burden associated with this requirement is exempt under both 5 CFR 1320.3(b)(2) and 5 CFR 1320.3(b)(3). As defined in 5 CFR 1320.3(b)(2), this process is a usual and customary business practice. As defined in 5 CFR 1320.3(b)(3), a State requirement would exist even in the absence of the Federal requirement. The associated burden is thereby exempt from the PRA.
Section 418.106(c)(2) states that a hospice that provides inpatient care directly in its own facility must have a written policy in place that promotes dispensing accuracy. Additionally, this section requires that a hospice that provides inpatient care directly must maintain current and accurate records of the receipt and disposition of all controlled drugs. The burden associated with this requirement is the time and effort necessary to develop, draft, implement, and maintain a written policy that promotes dispensing accuracy and to maintain controlled drug records. The existence of this type of policy and these records are usual and customary business practices. The burden associated with this section is exempt from the PRA under 5 CFR 1320.3(b)(2).
Section 418.106(e) discusses the standard for labeling, disposing and storing of drugs and biologicals. Specifically, § 418.106(e)(2)(i) states that a hospice must have a written policy for the management and disposal of controlled drugs in the patient's home. As required by § 418.106(e)(2)(i)(A), a hospice must provide a copy of the written policy required in § 418.106(e)(2)(i) to the patient, and his/her representative and family. Additionally, the hospice must discuss the hospice policy for managing the safe use and disposal of controlled drugs with the patient or representative and the family in a language and manner they can understand to ensure that these parties are educated regarding the safe use and disposal of controlled drugs, as required by § 418.106(e)(2)(i)(B). Section 418.106(e)(2)(i)(C) requires a hospice to document in a patient's clinical record that the written policy for managing controlled drugs was provided and discussed. Section 418.106(e)(2)(ii) states that a hospice maintain current and accurate records of the receipt and disposition of all controlled drugs.
The burden associated with the requirements contained in § 418.106(e)(2) is the time and effort necessary to provide a written copy of the policy on the management and disposal of controlled drugs in the patient's home to the patient representative and family. There is also some burden associated with the hospice explaining the policy to the patient or representative and the family. In addition, there is a burden associated with documenting in the patient's clinical record that the written policy for managing and controlled drugs was provided and discussed. We believe the burden associated with the aforementioned requirements is exempt from the PRA under 5 CFR 1320.3(b)(2), as they are part of the usual and customary business practice for hospices.
Section 418.106(e)(3)(ii) states that the hospice pharmacist and the hospice administrator are required to immediately investigate any discrepancies in the acquisition, storage, dispensing, administration, disposal, or return of controlled drugs. The event must be reported to the appropriate State authority. A written account of the investigation must be made available to State and Federal officials if required by law or regulation. The burden associated with this requirement is exempt under both 5 CFR 1320.3(b)(2) and 5 CFR 1320.3(h)(6). As defined in 5 CFR 1320.3(b)(2), documenting an investigation and reporting the investigation to the appropriate State authority is a usual and customary business practice. Additionally, the burden associated with making a written account of the investigation available to State and Federal officials upon request is exempt from the PRA under 5 CFR 1320.3(h)(6); the information will be collected from individual hospices on a case by case basis. As stated under in 5 CFR 1320.3(h)(6), information collection requests addressed to a single “person” as defined in 5 CFR 1320.3(b)(4), are exempt from the PRA.
Section 418.106(f)(1) states that a hospice must ensure that repair and routine maintenance policies are developed in situations when a manufacturer's recommendation for a piece of equipment is nonexistent. Section 418.106(f)(2) requires a hospice to ensure that the patient, family, and other caregivers receive instruction in the safe use of durable medical equipment and supplies. After providing instruction, the patient, family, and/or caregiver must be able to demonstrate the appropriate use of durable medical equipment. The burden associated with the requirements in § 418.106(f)(1)-(2) is the time and effort necessary to develop, draft, implement, and maintain repair and routine maintenance policies. There is also burden associated with providing proper instruction on the use of durable medical equipment to patient, family members, and caregivers. As defined in 5 CFR 1320.3(b)(2), providing proper instruction on the use of durable medical equipment to patient, family members, and caregivers is a usual and customary business practice.
Section 418.108(c) requires the use of a written agreement if a hospice has an arrangement with a facility to provide short-term inpatient care. At a minimum, the agreement must address the issues outlined in § 418.108(c)(1)-(6). The burden associated with this requirement is the time and effort necessary to develop, draft, execute, and maintain the written agreement. While this requirement is subject to the PRA, the burden is exempt under 5 CFR 1320.2(b)(2). The use of the written agreements between facilities is a usual and customary business practice.
Section 418.110(c)(1)(ii) states that a hospice must have a written disaster preparedness plan in effect to manage emergencies that might compromise the hospice's ability to provide care. Additionally, the plan must be periodically reviewed. The burden associated with this requirement is the time and effort necessary to develop, draft, implement, maintain, and periodically review the disaster preparedness plan. Section 418.110(c)(2) requires hospices to develop procedures for managing physical plant issues.
The burden associated with the requirements in § 418.108(c) is the time and effort necessary to draft, implement, maintain, and review the facility's disaster preparedness plans and procedures to address physical plant issues. While these requirements are subject to the PRA, we believe the associated burden is exempt as stated in 5 CFR 1320.3(b)(2).
Section 418.110(m)(3)(i) specifies that the use of restraint and seclusion must be used in accordance with a written modification to the plan of care. The use of restraint and seclusion must be implemented in accordance with safe and appropriate restraint and seclusion techniques as determined by hospice policy in accordance with State law. The burden associated with this requirement is the time and effort necessary to modify the plan of care in writing to include the physician order for restraint and seclusion.
Section 418.110(m)(4) states that the use or restraint or seclusion must be done in accordance with a physician's orders. There is a burden associated with creating a physician's order. However, we believe the burden associated with the aforementioned requirements is exempt from the PRA under 5 CFR 1320.3(b)(2), as they are part of the usual and customary business practice for hospices.
Section 418.110(m)(7)(ii) states that prior to writing a new order for the use of restraint or seclusion, a physician must see and assess the patient. The burden associated with this requirement is the time and effort necessary for the ordering physician to see and assess the patient.
Section 418.110(m)(15) states that when restraint or seclusion is used, a patient's clinical record must contain the documentation outlined in § 418.110(m)(15)(i)-(v). The burden associated with this requirement is the time and effort necessary to compile the documentation specified in § 418.110(m)(15)(i)-(v) in the patient's clinical record. We estimate the collective burden associated with the requirements contained in 418.110(m)(3)(i), 418.110(m)(7)(ii), and 418.110(m)(15) to be 45 minutes per event per hospice for a total of 8,702 events annually. The annual burden associated with the aforementioned information collection requirements is 6,527 hours.
Section 418.110(n) discusses the standard for restraint or seclusion staff training requirements. Specifically, § 418.110(n)(1) states that all patient care staff working in the hospice inpatient facility must be trained and able to demonstrate competency in the application of restraints, implementation of seclusion, monitoring, assessment and providing care for a patient in restraint or seclusion. Section 418.110(n)(4) states that a hospice must document in the personnel records that each employee successfully completed the restraint and seclusion training and demonstrated competency. We estimate that it will take 96 hours to comply with these requirements. The estimated total annual burden associated with these requirements is 275,512 hours.
Section 418.110(o) states that hospices must report deaths associated with the use of restraint or seclusion. The hospice staff must document in the
Section 418.112(c) discusses the requirement that a hospice and SNF/NF or ICF/MR must have a written agreement that specifies the provision of hospice services in the facility. The agreement must be signed by authorized representatives of the hospices and the SNF/NF or ICF/MR prior to the provision of hospice care services. At a minimum, the written agreements must address the issues listed in § 418.112(c)(1)-(8). The burden associated with this requirement is the time and effort necessary to develop, draft, sign, and maintain the written agreement. However, the use of this type of written agreement is a usual and customary business practice; the associated burden is exempt from the PRA under 5 CFR 1320.3(b)(2).
Section 418.112(d) discusses the standard for the hospice plan of care. A written plan of care must be established and maintained in consultation with SNF/NF or ICF/MR representatives. The burden associated with this requirement is discussed in detail under our discussion of § 418.56(c).
Section 418.114(d)(1) requires hospices to obtain criminal background checks on all hospice employees who have direct patient contact or access to patient records. Additionally, all hospice contracts must require that all contracted entities obtain criminal background checks on contracted employees who have direct patient contact or access to patient records. The burden associated with this requirement is the time and effort necessary to conduct background checks and the time and effort necessary to develop, draft, and maintain contracts that require all contracted staff to obtain background checks. While this requirement is subject to the PRA, we believe the associated burden is exempt as stated in 5 CFR 1320.3(b)(2). While fulfilling these requirements, a hospice will not incur any burden above and beyond its usual and customary business practice.
We have submitted a copy of this final rule to OMB for its review of the information collection requirements contained within this document. These requirements are not effective until they are approved by OMB.
We have examined the impacts of this rule as required by Executive Order 12866 (September 1993, Regulatory Planning and Review), the Regulatory Flexibility Act (RFA) (September 16, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.
Executive Order 12866 (as amended by Executive Order 13258, which merely reassigns responsibility of duties) directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($110 million or more in any 1 year). This is not a major rule, since the overall economic impact for all proposed new Conditions of Participation is estimated to be $40.7 million in the first year.
The RFA requires agencies to analyze options for regulatory relief of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small government jurisdictions. Individuals and States are not included in the definition of a small entity. For purposes of the RFA, most hospices (approximately 82% of Medicare certified facilities) are considered to be small entities, either by virtue of their nonprofit or government status or by having revenues of less than $12.5 million in any one year (for details, see the Small Business Administration's regulation that sets forth size standards for health care industries at 65 FR 69432). We estimate there are approximately 2,872 hospices with average admissions of approximately 303 patients per hospice (based on the number of patients in 2005 divided by the number of hospices in 2005). The National Hospice and Palliative Care
We certify that this rule would not have a significant impact on a substantial number of small entities because the cost of this rule is less than 1 percent of total hospice Medicare revenue. According to the CMS 2005 national expenditure data, Medicare paid $8.2 billion to providers for hospice care in FY 2005. We estimate this rule will cost hospices approximately $40.7 million or approximately $32,223 per average hospice (operating its own inpatient unit and requiring the supervisory services of an MSW) in the first year. An average hospice that does not operate its own inpatient unit and does not need to hire an MSW, accounting for the vast majority of hospices, will expend $11,151 to comply with this final rule in the first year. While we understand that a few very small hospices (described below) may expend a larger percentage of their revenue to comply with this rule, we believe that this group of hospices is quite small.
We understand that there are different sizes of hospices and that the burden for hospices of different sizes will vary. Therefore, we have assessed the burden for hospices that are smaller than the statistically average hospice used for calculations in part B of this section, Anticipated Effects on Hospices. The smaller hospices have been broken up into two categories based on the number of routine home care days, the most common level of hospice care provided. The categories are group 1 hospices providing 0 to 1,754 routine home care days, and group 2 hospices providing 1,755 to 4,373 routine home care days. Group 1 hospices, averaging 67 patients per year, would spend approximately $18,980 or $5,980, depending on the need to hire and MSW supervisor, to comply with these regulations. The average hospice in this group received $229,406 from Medicare for routine home care days under the 2005 hospice payment rates. Group 2 hospices, averaging 167 patients per year, would spend approximately $21,191 or $8,191, also depending on the need to hire an MSW supervisor, to comply with these regulations. The average hospice in this group received $571,945 from Medicare for routine home care days under the 2005 rates.
The time and cost burden for these providers is less than that of the average hospice used in part B of this section because a portion of the burden associated with these regulations is directly related to patient care and the staff necessary to provide care. Therefore, a consistently smaller patient census leads to reduced burden because the smaller hospices have less staff, complete less data collection and less patient rights orientation etc. These estimates of the annual burden for smaller hospices make only minor adjustments to the estimated quality assessment and performance improvement burden described in part B of this section in the area of patient level data collection. Additionally, these figures do not include the time and cost burden estimates associated with a hospice inpatient facility because it is very uncommon for a hospice with a small annual patient census to operate its own inpatient facility. We estimate that the financial burden for group 1 hospices would be approximately 8.25 or 2.5 percent of the payment received for routine home care days, depending on whether or not the hospice needs to hire an MSW supervisor. For group 2 hospices, the financial burden would be 3.75 or 1.5 percent of the payment received for routine home care days, also depending on whether or not the hospice needs to hire an MSW supervisor. Since employing an MSW is considered the standard within the hospice industry, we believe that very few group 1 and 2 hospices will incur the additional expense of hiring an MSW above their present level of staffing (see B., Anticipated Effects on Hospices, Personnel qualifications for a more detailed discussion). These percentages do not include amounts paid by Medicare for continuous home care days, respite care days, and regular inpatient care days. The percentages also do not include amounts paid by Medicaid, private insurers, and individual patients, which account for approximately 18 percent of hospice revenue. Additionally, these percentages do not include additional income from fundraising, donations, foundations, etc. that hospices routinely use to finance operations and programs. Therefore, we believe that the actual cost incurred by a group 1 or a group 2 hospice accounts for a significantly smaller portion of hospice's overall revenue, and does not have a significant impact on a substantial number of small entities.
In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a metropolitan statistical area and has fewer than 100 beds. We believe that this rule would not have a significant impact on the operations of a substantial number of small rural hospitals, since there are few hospice programs in those facilities. Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any one year of $100 million in 1995 dollars, updated annually for inflation. That threshold level is currently approximately $127 million. This final rule does not contain mandates that will impose spending costs on State, local, or tribal governments in the aggregate, or by the private sector of $127 million.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a final rule that imposes substantial direct compliance costs on State or local governments, preempts State law, or otherwise has Federalism implications. This rule has no Federalism implications.
As described in the preamble, this final rule contains both new provisions and provisions that are carried over from the existing hospice regulations. For purposes of this section, we have assessed the impact of all provisions that may present a burden to a hospice.
Within this section, we have made several assumptions and estimates in order to assess the time that it would take for a hospice to comply with the provisions and the associated costs of compliance. We have detailed these assumptions and estimates in the table below. We have also detailed many, but not all, of the standards within each CoP, and have noted whether or not there is an impact for each. However, the requirements contained in many provisions are already standard medical or business practices. These requirements would, therefore, not provide additional burden to hospice providers.
Our assumptions are based on the idea of an average hospice, culled from national averages. While we understand that there is no average hospice, the idea of an average hospice allows us to quantify the impact of this final rule on a hospice's resources. For purposes of this section only, we describe an average hospice as one that is:
The final rule expands on the informed consent section (§ 418.62) of the current rule, recognizing that hospice patients are entitled to certain rights that must be protected and preserved, and that all patients must be able to freely exercise those rights.
We expect that a hospice administrator will investigate alleged patient rights violations. We estimate that as many as 5% (15) of an average hospice's patients would require a one-hour-long investigational session, for a total of 15 hours per hospice. The cost for the entire hospice industry would be $2,110,920 a year, while the cost for an average hospice would be $735 a year.
The final rule makes several changes to the existing rule to improve patient care and lessen burden.
The quality assessment and performance improvement (QAPI) requirement builds off of the existing quality assurance requirement. Indeed, quality assurance is already part of standard hospice practice. This rule requires a data-driven approach to assessing and improving quality in all aspects of hospice care, from clinical services to staffing to contracts, that enables hospices to develop a clear understanding of their strengths and weaknesses in a wide variety of areas. However, at this time we do not prescribe the precise areas that each hospice must examine, nor do we prescribe the precise mechanisms for these examinations. Rather, we provide a basic outline of what QAPI is and how we expect it to function in the hospice environment. Each hospice is free to decide how to implement the QAPI requirement in a manner that reflects its own unique needs and goals.
In response to public comments stating that we underestimated the impact of the QAPI CoP on the average hospice, we have significantly revised our impact assessment methodology. Rather than describing the impact in proportion to the impact that this same CoP had on hospitals, we have described the impact in three general phases that we believe an average hospice will go through. These phases are based off of our experience in implementing the QAPI requirements of the proposed rule in the Rural Hospice Demonstration project required by section 409 of the MMA, and from discussions with hospice industry representatives who are active in implementing QAPI programs nationwide. The description of these phases, and the hour and dollar estimates that accompany them were not available at the time that the proposed hospice rule was published. We believe that this new information more accurately reflects the hospice environment.
While we have outlined these phases below, we stress that a hospice is not required to approach QAPI in this manner. We are not requiring a hospice to collect data for a specific domain; use specific quality measures, policies and procedures, or forms; submit data to an outside body; or conduct a specified number of performance improvement projects. A hospice may choose to implement a data-driven, comprehensive QAPI program that meets the requirements of this rule in any way that meets its individual needs. These phases described below simply provide a framework for assessing the potential impact of the QAPI requirement upon an average hospice.
In phase one, we believe that a hospice will:
Identify quality domains and measurements that reflect its organizational complexity; involve all hospice services; affect palliative outcomes, patient safety, and quality of care; focus on high risk, high volume, or problem-prone areas; and track adverse patient events;
Develop policies and procedures to ensure that data is consistently collected, documented, retrieved, and analyzed in an accurate manner; and
Educate hospice employees and contractors about the QAPI requirement, philosophy, policies, and procedures.
In phase two, we believe that a hospice will:
Enter data into patient clinical records during patient assessments and IDG meetings;
Aggregate data by collecting the same pieces of data from patient clinical records and other sources (for example, human resource records, pharmacy records, etc.);
Analyze the data that is aggregated through charts, graphs, and various other methods to identify patterns, anomalies, areas of concern, etc. that may be useful in targeting areas for improvement; and
Develop, implement, and evaluate major and minor performance improvement projects based on a thorough analysis of the data collected.
In phase three, we believe that a hospice will:
Identify new domains and measures that may replace or be in addition to the domains and measures already being monitored by the hospice;
Develop and/or revise policies and procedures to accommodate the new domains and measures; and
Educate hospice employees and contractors on the new domains and measures, as well as the policies and procedures for them.
In addition to these three phases, a hospice will likely allocate resources to an individual responsible for the general overall coordination of its QAPI program. For simplicity, we refer to this individual as the QAPI coordinator; however, a hospice is not required to use this title.
Based on these three phases, we have anticipated the impact of the QAPI requirement on a hospice's resources. In phase one, we anticipate that a hospice will use 12 hours to identify quality domains and measures. These hours will be distributed among the three members of the hospice's QAPI committee. While we do not require a hospice to have a QAPI committee, we believe that most hospices will choose to do so. The hospice model is based on the idea of an interdisciplinary group of people working together, and we believe that hospices will choose to use this group decision-making model in the QAPI process as well. We believe that the QAPI committee will include the QAPI coordinator, the hospice administrator, and a clinical manager. We estimate that the QAPI committee will meet four times quarterly for 1 hour each meeting to identify appropriate quality domains and measures. The total cost for an average hospice to identify the domains and measures, then, is $480.
While we anticipate that a hospice will use resources to develop policies and procedures and educate staff, we believe that these activities are part of standard business practice and do not pose an additional burden to a hospice. For example, a hospice already conducts a regular in-service training program for its employees in accordance with the in-service training requirement at existing § 418.64. A hospice can incorporate QAPI training into this existing in-service training program with no associated increase in burden.
In phase two, we anticipate that a hospice will use 91 hours to enter data (at the time of each assessment, 40.4 hours + at the time of each IDG meeting, 50.5 hours), 48 hours to aggregate data, and 12 hours to analyze data. Although thoroughly assessing a patient is already standard practice, we believe that collecting quality measure data during the patient assessment will be a new practice for many hospices. We estimate that a hospice will spend 40.4 hours a year to collect patient-level quality data during patient assessments, and that a registered nurse is the most likely person to perform this data collection.
The QAPI CoP requires a hospice to use the quality data collected during the patient assessment during the IDG meeting to monitor the effectiveness of interventions in helping the patient and family achieve desired outcomes. While a hospice IDG already makes decisions based on the information contained in the patient's clinical record, they may not be systematically documenting this analysis and its results. We believe that documenting the results of the data analysis (for example, any changes to the plan of care based on the specific quality measure data) during the IDG meeting will require additional time for each patient. We estimate that this activity will require 50.5 hours for an average hospice, based on an assumed five minutes per patient to document quality measure analysis. We believe that the registered nurse assigned to coordinate the patient's plan of care is the individual most likely to document this information.
In addition to using quality measure data on a patient level, a hospice must gather the patient-level data and other data. Once gathered, a hospice must organize the data in a meaningful way. We estimate that, in order to ensure that the volume of gathered data is manageable, a hospice will gather its data once a month. A hospice may choose to gather data on a more or less frequent basis to suit its needs and circumstances. Some hospices may choose to gather all patient-level data, while others may choose to gather data from a sample of all patient-level data. Likewise, some hospices may choose to gather data from a wide variety of administrative files, while others may choose to select only a few administrative data sources. There are many combinations that a hospice may choose to use when it comes to gathering data, and no single approach is considered preferable to another. Given this variability, it is difficult to estimate how long an average hospice may spend gathering and organizing data. For purposes of this analysis only, we assume that an average hospice will use four hours per month to gather data, for a total of 48 hours a year. We believe that an office employee will perform the data aggregation and organization.
Following data gathering and organization, a hospice must analyze the data to identify trends, patterns, anomalies, areas of strength and concern, etc. We believe that this data analysis will be done by the QAPI committee described previously. In order to identify trends and patterns, the committee would need to examine several months of data at the same time. Therefore, we assume that the committee will meet once every quarter to examine the data and make decisions based off of it. We assume that these meetings will be one hour each, for a total cost of $480.
Performance improvement projects follow all of the data entry, gathering, organization, and analysis. A hospice must conduct projects to improve its performance in areas where a weakness is identified. Performance improvement projects must reflect the hospice's scope, complexity, and past performance. They must also be data-driven, and affect palliative outcomes, patient safety, and quality of care. Although this final rule more clearly describes a performance improvement project, its basis, and its purpose, are fundamentally the same as the current requirement at § 418.66, “Quality assurance.” That requirement states that, “A hospice must * * * correct identified problems and * * * revise hospice policies if necessary * * * [and] [m]ake suggestions for improving patient care.” Since a hospice already makes an organized effort to improve patient care in all of its facets, and since providing safe and effective care at all times for all patients is the essential charge of all health care providers, including hospices, we believe that conducting both major and minor performance improvement projects is already a standard of practice within the hospice industry. Therefore there is no additional burden associated with this provision.
Phase three of the QAPI process builds upon the QAPI program that a hospice already has in place. We estimate that a hospice will use three hours a year to identify new domains and quality measures, and we believe that the QAPI committee will perform this task. Just as in phase one, we believe that the tasks of developing and/or updating the hospice's policies and procedures and educating the hospice's staff and contractors are standard practice within the hospice industry.
In order to ensure the adequate functioning of a hospice's QAPI program, a hospice must designate an individual to be responsible for its QAPI program. We estimate that a QAPI coordinator will spend 1.5 hours per week overseeing the QAPI program, performing various functions as needed, for a total of 78 hours per year.
There is no specific existing requirement for infection control other than what is briefly mentioned in the existing § 418.100(i), “Standard: Isolation areas.” However, we believe that hospice clinicians such as nurses, physicians, and therapists are already using infection control practice as part of the current requirement that hospice clinicians provide services to patients in accordance with accepted standards of practice. It is an accepted standard of practice to use infection control methods when caring for patients. This final regulation reinforces those positive infection control practices and addresses the serious nature of infectious and communicable diseases. Infection control and standard precautions are long-standing clinical practices that are standard throughout the medical industry.
This final CoP requires a hospice to continue to take specific and appropriate actions to address the prevention and control of infections, including patient, staff, and caregiver education. We acknowledge that this is a new focus; however, we do not believe this will add any regulatory burden, since this section of the final rule reflects contemporary standard practice in hospice programs.
The final rule allows core services to be provided under contract in certain extraordinary or other non-routine circumstances as described, allowing hospices more flexibility. One specific provision allows a hospice to contract for highly specialized nursing services, providing even more staffing flexibility. The option to contract out for highly specialized nursing services allows a hospice to provide such highly specialized services at a lower cost than if it directly employed an individual(s) to perform such services. A hospice that chooses to contract for core services or highly specialized nursing services must have a contract with the entity providing the contracted services. Negotiating, documenting and signing a business contract is standard business practice and does not impose a burden.
This waiver, currently implemented through a memorandum from CMS's Center for Medicaid and State Operations, will reduce the compliance burden on hospices located in non-urbanized areas. If the hospice program demonstrates that recruitment efforts were unsuccessful, it may request certain waivers with respect to PT, OT, speech-language pathology, and dietary counseling. There have been no applications for this waiver in the past 5 years; therefore we believe that the burden is negligible.
Hospice aide and homemaker services are an integral part of hospice care, yet they receive little attention in the current regulation. These services are briefly addressed in § 418.94 with a standard regarding the supervision of home health aide services and a standard regarding written patient care instructions. These two standards appear in the final regulation, with some minor alterations. The final regulation also adds several new requirements.
These three standards describe the ways in which a hospice aide can meet the qualification requirements. All of these standards require the hospice to maintain documentation that each hospice aide meets these qualifications. The burden associated with these standards is the time to complete the required documentation. We estimate that it will take five minutes to document the information and that an office employee will complete this task. In addition, we have calculated the burden based on an employee turnover rate of 30% (2002 NHPCO National Data Set Summary Report), meaning that we expect that the average hospice would replace 30% of its hospice aides in a given year, or roughly one hospice aide a year based on the employment of 5 hospice aides. Based on the above-mentioned estimates and assumptions, we estimate that will cost an average hospice $1.17 to document that its hospice aides meet the qualification
The revised requirements for the organization and administration of services are essentially the same as those in the previous conditions of participation. We added a requirement to clarify the relationship between the hospice governing body and the hospice administrator. This clarification presents no burden for a hospice.
This rule includes a new requirement that a hospice must designate a physician to assume the role and responsibilities of the medical director when the medical director is not available. All hospices routinely meet the medical needs of their patients 24 hours a day, including the need for physician services. As such, they must already have a physician available at all times. A single physician cannot fulfill this 24-hour a day hospice physician role; therefore hospices already have more than one physician available. We believe that identifying the alternative physician as the physician designee, ready and able to fulfill the medical director role in the medical director's absence, does not pose a burden to a hospice.
This rule adds specificity in regard to content, authentication, retrievability, retention, and transfer of records. It requires a hospice to include all relevant patient care information in each patient's clinical record in order to facilitate communication and coordination among all disciplines involved in a patient's care. It also requires a hospice to ensure that clinical record entries are legible, clear, complete, and authenticated in
(e)
For purposes of our analysis only, we are estimating the impact of this provision based on the assumption that an average hospice will choose to use a pharmacist to meet this requirement. We have made this assumption based on two factors. First, pharmacists are relatively easier to access in most parts of the country as compared to clinicians who have specialized drug management education and training. Second, pharmacist services can be easily accessed by phone and electronic communications through a local pharmacy or a pharmacy benefit management company. Hospices are in no way required to use a pharmacist to fulfill this role. We estimate that an average hospice already spends $123,842 annually to provide drugs and biologicals for its patients ($15.72 per patient day (dollar figure is not adjusted for inflation) for drugs and biologicals based on 2001 Millman USA report titled “The Costs of Hospice Care: An Actuarial Evaluation of the Medicare Hospice Benefit” and consistent with the 2002 NHPCO National Data Set). Based on discussions with the leading hospice pharmacy benefit management company, for approximately this same price ($12-18 per patient day), a hospice may contract with a pharmacy benefit management company to provide all drugs and biologicals for its patients. In addition, the pharmacy benefit management company allows a hospice IDG to speak with a pharmacist on a 24-hour basis to gather information, input, and advice from the pharmacist regarding an individual patient's drug and biological profile. Contracting with a pharmacy benefit management company and utilizing its pharmacists satisfies the new requirement without increasing a hospice's expenditures beyond what it is currently spending to provide drugs and biologicals alone. Since hospices currently have the option of contracting with a pharmacy benefit management company to comply with this requirement without increasing overall pharmacy costs, we do not believe that this new requirement poses a burden to a hospice. As of January 2008 approximately 1,600 hospices currently use the services of pharmacy benefit management companies.
If a hospice decides not to use a pharmacy benefit management company, it may also choose to employ or contract with a pharmacist(s) for pharmacist advisement services. A hospice that chooses to use the services of a pharmacist (or other individual with specialized education and training in drug management) in lieu of a pharmacy benefit management company retains the responsibility and flexibility of managing the purchase of drugs and biologicals. We estimate that it requires 30 minutes for an individual such as a pharmacist to initially review a patient's drug and biologicals profile and advise the IDG during the time of the patient's comprehensive assessment and development of the plan of care. Additionally, we estimate that it requires 15 minutes of a individual's time to review updates to the patient's drug profile and advise the IDG about updates to the patient's plan of care. Based on a 26 day median length of stay, patients would likely receive two updates to their plans of care. Using these estimates, a hospice would expend $56 per patient to secure pharmacist advisement services. An average hospice would expend $16,968 annually to secure pharmacist advisement services for all of its patients. We have not estimated the cost associated with a hospice using an individual from another clinical discipline who has specialized education and training in drug management because we are unsure of what disciplines would be used in this role, depending upon the needs of each hospice.
The rule requires the hospice's pharmacist and administrator to conduct controlled drug investigations. We estimate that a thorough investigation, including an examination of the records of incoming and outgoing drugs and biologicals, and report would require one hour per incident. The entire industry would thus spend six hours annually at a cost of $624 to fulfill this requirement. Maintaining inventory records incoming and outgoing drugs and biologicals is a usual and customary business practice and is not a burden.
In addition, we added a requirement regarding documentation of patient and family drug education. A hospice must document in the patient's clinical record that it provided a copy of its controlled drug policy to the patient and family at the time when a controlled drug is first ordered. A hospice must also document that it discussed the controlled drug policy with the patient and family. Documenting the provision of the material and the education session requires approximately five minutes, and will likely be completed by a registered nurse. Fulfilling the requirement would cost $2.25 per patient based upon the average hourly rate for a registered nurse.
The vast majority of hospices provide durable medical equipment and supplies under contract with one or more vendors. For this reason, we added a requirement that a hospice may only contract with a durable medical equipment supplier that meets the Medicare DMEPOS Supplier Standards at 42 CFR 424.57. We do not believe that this requirement will compromise a hospice's ability to secure a contract or significantly increase the cost of that contract because most vendors choose to meet the Medicare Supplier Standards in order to furnish equipment and supplies to Medicare beneficiaries. Therefore, there is sufficient competition among vendors to provide high quality services at a reasonable cost to hospices seeking contracts.
Have and rehearse a disaster preparedness plan;
Manage all aspects of the building (that is, waste, water supply, and ventilation);
Comply with applicable fire safety requirements;
Have a home-like atmosphere with sufficient space and amenities;
Have an adequate infection control program;
Have clean linens and properly handle soiled ones; and
Serve meals to meet patient needs.
These requirements are standard practice in hospice-operated inpatient facilities and pose no additional burden.
Section 418.110(m)(6) requires that the medical director or physician designee must be consulted as soon as possible if the attending physician did not order the restraint or seclusion. Although this may minimally increase burden to hospices, we believe it is a best practice for patient safety.
We have added elements at § 418.110(m)(14) that monitoring must occur face-to-face by trained staff or by using both video and audio equipment, when there is simultaneous use of restraint and seclusion. We have added elements at § 418.110(m)(15) regarding the documentation that must be included in the patient's medical record when the patient is restrained or secluded, including the 1-hour face-to-face medical and behavioral evaluation if restraint or seclusion is used to manage violent or self-destructive behavior, the patient's behavior and intervention used, alternatives or other less restrictive interventions attempted (as applicable), the patient's condition or symptom(s) that warranted restraint or seclusion use, and the patient's response to the use of the restraint or seclusion intervention, including the need for continued use of restraint or seclusion. We do not believe additional burdens are imposed by this requirement since it is a routine and customary practice to document the circumstances surrounding such an event for comprehensiveness of patient care.
In response to the December 19, 1997 proposed rule that we published concerning the use of seclusion and restraint in hospitals, the National Association of Psychiatric Health Systems (NAPHS) supplied data from fifty members for the time and cost of complying with the CMS requirements that a physician evaluate a patient face-to-face within 1 hour of the initiation of restraint or seclusion. The NAPHS stated their respondents reported it took an estimated 30 minutes to 1 hour to document all the specific elements required by CMS after a restraint or seclusion episode. This included several elements unique to the rule such as physician notification if the restraint was ordered by someone other than the patient's attending physician.
We believe that the time associated with documenting seclusion or restraint episode in a hospice is similar to that in a hospital. Thus, our burden estimate is based on a median timeframe (that is, 45 minutes) that we believe it takes to complete the required documentation in the patient's clinical record. However, since we are unable to estimate the prevalence of restraint and seclusion, we can not apply this estimate to assess the associated burden across hospices.
To reduce burden and create a reasonable requirement while assuring patient safety, we have mandated that only those staff who are involved in the application of restraint or seclusion or performing associated monitoring and assessment of, or providing care for restrained or secluded patients have this training. While we expect physicians to be trained in the proper use of restraint or seclusion, we do not expect that they will be trained with the other hospice staff. Thus, we have not included physicians in the burden associated with these requirements. Instead, we require the remaining hospice staff who have direct contact with patients must be trained in restraint or seclusion use.
In this final rule, we have specified broad topics to be covered in training, and have not required that staff be trained by an outside organization. We believe that in-house training may be more economical than sending staff off-site for instruction. However, hospices have the option of sending either selected or all staff to outside training if they believe that this is warranted.
Thus, we have based our burden estimate on having the actual number of trainers attend the training from an outside organization one time. We believe that most hospices would, in turn, have these trained individuals function as program developers and trainers of the appropriate hospice staff. We believe in most instances this professional will be a registered nurse.
Train-the-trainer programs are the way many hospices provide staff instruction. The four day instructor certification program given by the Crisis Prevention Institute (CPI, INC.) costs $1,200 dollars in tuition plus travel, lodging, and participant salary (HYPERLINK “
We estimate, on average, that roundtrip travel for each nurse will cost approximately $400 to cover the need for either local or distant travel, lodging for each nurse will costs approximately $120 per night × 3 nights, and the meals and incidental expenses (M&IE) will be approximately $50 per day depending upon the location within the designated state. Thus, we anticipate the cost to train one nurse would be $3,280. If all 906 hospices (estimate based on March 2006 Hospice Facts & Statistics report from the Hospice Association of America that 31.54 percent of hospices have their own inpatient facilities) with inpatient facilities were to send one
We believe that hospices will add seclusion and restraint training onto their existing in-service training programs. The train-the-trainer program described above will provide hospices with the necessary personnel and materials to implement a staff-wide seclusion and restraint training program. We estimate that developing this staff-wide training program will require 40 hours of the trainer's time on a one-time basis for all affected hospices, at a cost of $1,400 per hospice inpatient facility.
We require that each individual who will potentially be involved in restraint and seclusion of a patient have training in the proper techniques. According to the NAPHS, initial training in de-escalation techniques, restraint and seclusion policies and procedures, and restraint and seclusion techniques range from 7 to 16 hours of staff and instructor time.
Using data from a March 2006 Hospice Association of America report, there were 116,148 total hospice employees and volunteers in 2005. Of these employees and volunteers, 32,412 employees and volunteers were nurses and physicians. Thus the average hospice operating its own inpatient facility has 11 nurse and physician employees and volunteers. We realize that some hospices will have more or less employees and volunteers to train. Based on one nurse trainer conducting an 8 hour training course for 11 hospice inpatient employees and volunteers, we estimate that this requirement will cost $3,360.
We require that each individual will receive annual updates to the training and that the annual training will also be documented. Again, according to NAPHS, annual updates are about 4 hours of staff and instructor time per each employee who has direct patient contact. Again, an average size hospice has 11 employees who have direct patient contact that must to be trained in de-escalation techniques. Therefore, we estimate that it will cost $1,680 annually to update each person's training.
Additionally, we required recordkeeping for documenting in each trained individual's personnel record that he or she has successfully completed training. We estimate that it will take the trainer 5 minutes per trainee to document each participant's completion of the training. As described above, we estimate that 11 hospice employees and volunteers will be trained.
Finally, we require that each hospice revise its training program annually as needed. We estimate this task, completed by the trainer, to take approximately 4 hours annually per hospice.
Each death referenced in this section must be reported to CMS by telephone no later than the close of business the next business day following knowledge of the patient's death. We have no data from which to base an estimate on the number of deaths in hospice that may be related to the use of seclusion and restraint. However, based on a lack of family complaints to State agencies or CMS we believe such deaths to be a rare occurrence. Although our goal is to ensure the safe and appropriate use of seclusion and restraint and reduce associated deaths, we are aware that the actual number of reported deaths from seclusion and restraint may increase due to these reporting requirements.
Thus, we anticipate there will be burden associated with this requirement due to the increased number of deaths that will be reported by the hospice industry. Given the lack of historical data, we assume the number of reports certainly should average less than one per hospice inpatient facility per year. Thus, we believe the impact associated with this provision (that is, making a telephone call and filling in a written report) to be negligible.
Any additional effort by hospice personnel to meet these requirements will, we believe, be offset by the reduced costs associated with the provision of more effective and efficient patient care. For example, by communicating and coordinating with a facility, a hospice can avoid situations where duplicative or contradictory orders are issued by the hospice physician and the facility physician. If duplicative orders are avoided, the hospice may be able to eliminate the duplicative service, thereby decreasing hospice expenditures while maintaining quality patient care. If contradictory orders are avoided, a hospice can avoid furnishing care that is rendered ineffective by the opposing care furnished by the facility. This, too, would decrease hospice expenditures, while at the same time improving the patient's well being.
Furthermore, the standard requires a hospice to provide a facility with specified information about the patient's care. With the exception of the election and advanced directives forms, certification forms, and physician orders, all of the specified information is routinely provided to a patient's caregiver(s). Since the facility is the caregiver, providing this information presents no burden to a hospice. We estimate that providing the facility with the election and advanced directives forms, certification forms, and physician orders for each patient would cost $2.33 per patient, based on 10 minutes of an office employee's time to fax the required documents to the facility. According to a March 2006 report from the Hospice Association of America (“Hospice Facts & Statistics”), 27.19 percent of hospice patients nationwide resided in a SNF or other long term care facility. Therefore, we estimate that hospices will provide forms to SNFs/NFs and ICFs/MR for 236,336 hospice patients residing in those facilities. We also estimate that the average hospice will provide care to 82 patients residing in a SNF/NF or ICF/MR (236,336 patients nationwide / 2,872 hospices).
• Have a Master of Social Work (MSW) degree from a school of social work accredited by the Council on Social Work Education and one year of experience in a health care setting;
• Have a baccalaureate degree in social work (BSW) from a school of social work accredited by the Council on Social Work Education and one year of experience in a health care setting; or
• Have a baccalaureate degree in psychology, sociology, or other field related to social work and at least one year of social work experience in a health care setting.
If a hospice chooses to employ a social worker with a baccalaureate degree in social work, psychology, sociology, or other field related to social work, the services of the baccalaureate social worker (BSW) must be provided under the supervision of a social worker with an MSW from a school of social work accredited by the Council on Social Work Education and one year of experience in a health care setting. The MSW supervisor role is that of an active advisor, consulting with the BSW on assessing the needs of patients and families, developing and updating the social work portion of the plan of care, and delivering care to patients and families. This supervision may occur in person, over the telephone, through electronic communication, or any combination thereof.
Social workers with a baccalaureate degree from a school of social work accredited by the Council on Social Work Education and who are employed by the hospice before the effective date of this final rule are exempted from the MSW supervision requirement. Therefore, if a hospice currently employs a BSW, it is not required to hire an MSW to supervise the BSW. If a hospice hires a new social worker with a baccalaureate degree and one year of experience in a health care setting, then the new baccalaureate social worker must be supervised by an MSW who has one year of experience in a health care setting.
The impact associated with this social work qualification requirement is the expense of employing an MSW to supervise a BSW. By virtue of the personnel qualifications for social workers in hospice that have been in effect since 1983, all hospices are already required to have, at minimum, a social worker with a baccalaureate degree in social work from a school of social work accredited by the Council on Social Work Education. Therefore, all hospices should qualify for the exemption for MSW supervision described above.
We are aware that many hospices already employ at least one MSW to provide direct patient care. In fact, when tracking the number of social workers serving hospice patients, the Hospice Association of America only reports the number of MSWs (6,177 in 2005) working in the hospice industry, rather than the number of BSWs, precisely because an MSW is the standard level of care within hospice. Thus, we believe that the number of hospices currently solely relying on BSWs is relatively low. We do not know the precise number of hospices without an MSW. For purposes of this estimate only, we assume that 33 percent of hospices (944) rely solely on BSWs to provide social work services to patients. Of the 944 hospices without an MSW, we estimate that 25 percent will hire a social worker after the effective date of this rule (based on a 25% social worker turnover rate described in the “Hospice Salary & Benefits Report 2006-2007” issued by the Hospital & Healthcare Compensation Service and the “2002 NHPCO National Data Set Summary Report”). Therefore, an estimated 236 hospices a year would be required to employ an MSW on a part-time basis to supervise the services of a BSW.
Based on information from the “Hospice Facts & Statistics 2006” report, the “Assuring the Sufficiency of Frontline Workforce: A National Study of Licensed Social Workers” report, and the “Licensed Social Workers in the United States, 2004” report, we estimate that the annual compensation for a full-time, supervisory, MSW working in the hospice industry is $52,811 ($25/hr). Furthermore, we estimate that a hospice would employ an MSW for 10 hours a week to supervise the care and services provided by a BSW. As such, we estimate that an affected hospice would spend $13,000 annually to employ a part-time supervisory MSW to meet the requirements of this rule.
We researched a wide variety of agencies that perform criminal background checks and determined that the average cost for an individual background check is $17.00 plus $1 for 6 minutes of clerical time per background check to process the paper work. We understand that some agencies or states may charge more or less than this fee to conduct a background check. In addition, some hospices may choose to conduct more extensive background checks that may cost more.
We are not requiring that hospices conduct a specific type of background check (that is, State or Federal) or obtain such a check from a specific source (that is, State police or FBI). The flexibility of the requirement will allow hospices to identify the most cost efficient method of meeting the requirement.
This final condition of participation requires that the hospice operate and furnish services in compliance with applicable Federal, State, and local laws and regulations related to the health and safety of patients. We do not believe this will add any regulatory burden, since this section of the final rule reflects current requirements and contemporary standard practice in hospice.
We believe that the burden associated with this rule is reasonable and necessary to ensure the health and safety of all hospice patients. In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and budget.
Effects on other providers: We do not expect this regulation to affect any other provider.
Health Facilities, Hospice Care, Medicare, Incorporation by reference, Reporting and record keeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services amends 42 CFR Chapter IV as set forth below:
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
This part establishes requirements and the conditions of participation that hospices must meet, and be in compliance with, in order to participate in the Medicare program. Subpart A of this part sets forth the statutory basis and scope and defines terms used in this part. Subpart B of this part specifies the eligibility requirements and the benefit periods. Subpart C of this part specifies the conditions of participation that hospice providers must meet regarding patient and family care. Subpart D of this part specifies the organizational environment that hospice providers must meet as conditions of participation. Subpart E is reserved for future use. Subpart F specifies coinsurance amounts applicable to hospice care.
The revisions and additions read as follows:
For the purposes of this part—
(2) A drug or medication when it is used as a restriction to manage the patient's behavior or restrict the patient's freedom of movement and is not a standard treatment or dosage for the patient's condition.
The patient has the right to be informed of his or her rights, and the hospice must protect and promote the exercise of these rights.
(1) During the initial assessment visit in advance of furnishing care the hospice must provide the patient or representative with verbal (meaning spoken) and written notice of the patient's rights and responsibilities in a language and manner that the patient understands.
(2) The hospice must comply with the requirements of subpart I of part 489 of this chapter regarding advance directives. The hospice must inform and distribute written information to the patient concerning its policies on advance directives, including a description of applicable State law.
(3) The hospice must obtain the patient's or representative's signature confirming that he or she has received a copy of the notice of rights and responsibilities.
(i) To exercise his or her rights as a patient of the hospice;
(ii) To have his or her property and person treated with respect;
(iii) To voice grievances regarding treatment or care that is (or fails to be) furnished and the lack of respect for property by anyone who is furnishing services on behalf of the hospice; and
(iv) To not be subjected to discrimination or reprisal for exercising his or her rights.
(2) If a patient has been adjudged incompetent under state law by a court of proper jurisdiction, the rights of the patient are exercised by the person appointed pursuant to state law to act on the patient's behalf.
(3) If a state court has not adjudged a patient incompetent, any legal representative designated by the patient in accordance with state law may exercise the patient's rights to the extent allowed by state law.
(4) The hospice must:
(i) Ensure that all alleged violations involving mistreatment, neglect, or verbal, mental, sexual, and physical abuse, including injuries of unknown source, and misappropriation of patient property by anyone furnishing services on behalf of the hospice, are reported immediately by hospice employees and contracted staff to the hospice administrator;
(ii) Immediately investigate all alleged violations involving anyone furnishing services on behalf of the hospice and immediately take action to prevent further potential violations while the alleged violation is being verified. Investigations and/or documentation of all alleged violations must be conducted in accordance with established procedures;
(iii) Take appropriate corrective action in accordance with state law if the alleged violation is verified by the hospice administration or an outside body having jurisdiction, such as the State survey agency or local law enforcement agency; and
(iv) Ensure that verified violations are reported to State and local bodies having jurisdiction (including to the State survey and certification agency) within 5 working days of becoming aware of the violation.
(c)
(1) Receive effective pain management and symptom control from the hospice for conditions related to the terminal illness;
(2) Be involved in developing his or her hospice plan of care;
(3) Refuse care or treatment;
(4) Choose his or her attending physician;
(5) Have a confidential clinical record. Access to or release of patient information and clinical records is permitted in accordance with 45 CFR parts 160 and 164.
(6) Be free from mistreatment, neglect, or verbal, mental, sexual, and physical abuse, including injuries of unknown source, and misappropriation of patient property;
(7) Receive information about the services covered under the hospice benefit;
(8) Receive information about the scope of services that the hospice will provide and specific limitations on those services.
The hospice must conduct and document in writing a patient-specific comprehensive assessment that identifies the patient's need for hospice care and services, and the patient's need for physical, psychosocial, emotional, and spiritual care. This assessment includes all areas of hospice care related to the palliation and management of the terminal illness and related conditions.
(a)
(b)
(c)
The comprehensive assessment must identify the physical, psychosocial, emotional, and spiritual needs related to the terminal illness that must be addressed in order to promote the hospice patient's well-being, comfort, and dignity throughout the dying process. The comprehensive assessment must take into consideration the following factors:
(1) The nature and condition causing admission (including the presence or lack of objective data and subjective complaints).
(2) Complications and risk factors that affect care planning.
(3) Functional status, including the patient's ability to understand and participate in his or her own care.
(4) Imminence of death.
(5) Severity of symptoms.
(6) Drug profile. A review of all of the patient's prescription and over-the-counter drugs, herbal remedies and other alternative treatments that could affect drug therapy. This includes, but is not limited to, identification of the following:
(i) Effectiveness of drug therapy.
(ii) Drug side effects.
(iii) Actual or potential drug interactions.
(iv) Duplicate drug therapy.
(v) Drug therapy currently associated with laboratory monitoring.
(7) Bereavement. An initial bereavement assessment of the needs of the patient's family and other individuals focusing on the social, spiritual, and cultural factors that may impact their ability to cope with the patient's death. Information gathered from the initial bereavement assessment must be incorporated into the plan of care and considered in the bereavement plan of care.
(8) The need for referrals and further evaluation by appropriate health professionals.
(d)
The update of the comprehensive assessment must be accomplished by the hospice interdisciplinary group (in collaboration with the individual's attending physician, if any) and must consider changes that have taken place since the initial assessment. It must include information on the patient's progress toward desired outcomes, as well as a reassessment of the patient's response to care. The assessment update must be accomplished as frequently as the condition of the patient requires, but no less frequently than every 15 days.
(e)
(2) The data elements must be an integral part of the comprehensive assessment and must be documented in a systematic and retrievable way for each patient. The data elements for each patient must be used in individual patient care planning and in the coordination of services, and must be used in the aggregate for the hospice's quality assessment and performance improvement program.
The hospice must designate an interdisciplinary group or groups as specified in paragraph (a) of this section which, in consultation with the patient's attending physician, must prepare a written plan of care for each patient. The plan of care must specify the hospice care and services necessary to meet the patient and family-specific needs identified in the comprehensive assessment as such needs relate to the terminal illness and related conditions.
(a)
(i) A doctor of medicine or osteopathy (who is an employee or under contract with the hospice).
(ii) A registered nurse.
(iii) A social worker.
(iv) A pastoral or other counselor.
(2) If the hospice has more than one interdisciplinary group, it must identify a specifically designated interdisciplinary group to establish policies governing the day-to-day provision of hospice care and services.
(b)
(c)
(1) Interventions to manage pain and symptoms.
(2) A detailed statement of the scope and frequency of services necessary to meet the specific patient and family needs.
(3) Measurable outcomes anticipated from implementing and coordinating the plan of care.
(4) Drugs and treatment necessary to meet the needs of the patient.
(5) Medical supplies and appliances necessary to meet the needs of the patient.
(6) The interdisciplinary group's documentation of the patient's or representative's level of understanding, involvement, and agreement with the plan of care, in accordance with the hospice's own policies, in the clinical record.
(d)
(e)
(1) Ensure that the interdisciplinary group maintains responsibility for directing, coordinating, and supervising the care and services provided.
(2) Ensure that the care and services are provided in accordance with the plan of care.
(3) Ensure that the care and services provided are based on all assessments of the patient and family needs.
(4) Provide for and ensure the ongoing sharing of information between all disciplines providing care and services in all settings, whether the care and services are provided directly or under arrangement.
(5) Provide for an ongoing sharing of information with other non-hospice healthcare providers furnishing services unrelated to the terminal illness and related conditions.
The hospice must develop, implement, and maintain an effective, ongoing, hospice-wide data-driven quality assessment and performance improvement program. The hospice's governing body must ensure that the program: Reflects the complexity of its organization and services; involves all hospice services (including those services furnished under contract or arrangement); focuses on indicators related to improved palliative outcomes; and takes actions to demonstrate improvement in hospice performance. The hospice must maintain documentary evidence of its quality assessment and performance improvement program and be able to demonstrate its operation to CMS.
(a)
(2) The hospice must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the hospice to assess processes of care, hospice services, and operations.
(b)
(2) The hospice must use the data collected to do the following:
(i) Monitor the effectiveness and safety of services and quality of care.
(ii) Identify opportunities and priorities for improvement.
(3) The frequency and detail of the data collection must be approved by the hospice's governing body.
(c)
(i) Focus on high risk, high volume, or problem-prone areas.
(ii) Consider incidence, prevalence, and severity of problems in those areas.
(iii) Affect palliative outcomes, patient safety, and quality of care.
(2) Performance improvement activities must track adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospice.
(3) The hospice must take actions aimed at performance improvement and, after implementing those actions, the hospice must measure its success and track performance to ensure that improvements are sustained.
(d)
(1) The number and scope of distinct performance improvement projects conducted annually, based on the needs of the hospice's population and internal organizational needs, must reflect the scope, complexity, and past performance of the hospice's services and operations.
(2) The hospice must document what performance improvement projects are being conducted, the reasons for conducting these projects, and the measurable progress achieved on these projects.
(e)
(1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained, and is evaluated annually.
(2) That the hospice-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness.
(3) That one or more individual(s) who are responsible for operating the quality assessment and performance improvement program are designated.
The hospice must maintain and document an effective infection control program that protects patients, families, visitors, and hospice personnel by preventing and controlling infections and communicable diseases.
(a)
(b)
(1) Is an integral part of the hospice's quality assessment and performance improvement program; and
(2) Includes the following:
(i) A method of identifying infectious and communicable disease problems; and
(ii) A plan for implementing the appropriate actions that are expected to result in improvement and disease prevention.
(c)
(a) Licensed professional services provided directly or under arrangement must be authorized, delivered, and supervised only by health care professionals who meet the appropriate qualifications specified under § 418.114 and who practice under the hospice's policies and procedures.
(b) Licensed professionals must actively participate in the coordination of all aspects of the patient's hospice care, in accordance with current professional standards and practice, including participating in ongoing interdisciplinary comprehensive assessments, developing and evaluating the plan of care, and contributing to patient and family counseling and education; and
(c) Licensed professionals must participate in the hospice's quality assessment and performance improvement program and hospice sponsored in-service training.
A hospice must routinely provide substantially all core services directly by hospice employees. These services must be provided in a manner consistent with acceptable standards of practice. These services include nursing services, medical social services, and counseling. The hospice may contract for physician services as specified in paragraph (a) of this section. A hospice
(a)
(1) All physician employees and those under contract, must function under the supervision of the hospice medical director.
(2) All physician employees and those under contract shall meet this requirement by either providing the services directly or through coordinating patient care with the attending physician.
(3) If the attending physician is unavailable, the medical director, contracted physician, and/or hospice physician employee is responsible for meeting the medical needs of the patient.
(b)
(2) If State law permits registered nurses to see, treat, and write orders for patients, then registered nurses may provide services to beneficiaries receiving hospice care.
(3) Highly specialized nursing services that are provided so infrequently that the provision of such services by direct hospice employees would be impracticable and prohibitively expensive, may be provided under contract.
(c)
(d)
(1)
(i) Have an organized program for the provision of bereavement services furnished under the supervision of a qualified professional with experience or education in grief or loss counseling.
(ii) Make bereavement services available to the family and other individuals in the bereavement plan of care up to 1 year following the death of the patient. Bereavement counseling also extends to residents of a SNF/NF or ICF/MR when appropriate and identified in the bereavement plan of care.
(iii) Ensure that bereavement services reflect the needs of the bereaved.
(iv) Develop a bereavement plan of care that notes the kind of bereavement services to be offered and the frequency of service delivery. A special coverage provision for bereavement counseling is specified in § 418.204(c).
(2)
(3)
(i) Provide an assessment of the patient's and family's spiritual needs.
(ii) Provide spiritual counseling to meet these needs in accordance with the patient's and family's acceptance of this service, and in a manner consistent with patient and family beliefs and desires.
(iii) Make all reasonable efforts to facilitate visits by local clergy, pastoral counselors, or other individuals who can support the patient's spiritual needs to the best of its ability.
(iv) Advise the patient and family of this service.
(a) CMS may waive the requirement in § 418.64(b) that a hospice provide nursing services directly, if the hospice is located in a non-urbanized area. The location of a hospice that operates in several areas is considered to be the location of its central office. The hospice must provide evidence to CMS that it has made a good faith effort to hire a sufficient number of nurses to provide services. CMS may waive the requirement that nursing services be furnished by employees based on the following criteria:
(1) The location of the hospice's central office is in a non-urbanized area as determined by the Bureau of the Census.
(2) There is evidence that a hospice was operational on or before January 1, 1983 including the following:
(i) Proof that the organization was established to provide hospice services on or before January 1, 1983.
(ii) Evidence that hospice-type services were furnished to patients on or before January 1, 1983.
(iii) Evidence that hospice care was a discrete activity rather than an aspect of another type of provider's patient care program on or before January 1, 1983.
(3) By virtue of the following evidence that a hospice made a good faith effort to hire nurses:
(i) Copies of advertisements in local newspapers that demonstrate recruitment efforts.
(ii) Job descriptions for nurse employees.
(iii) Evidence that salary and benefits are competitive for the area.
(iv) Evidence of any other recruiting activities (for example, recruiting efforts at health fairs and contacts with nurses at other providers in the area).
(b) Any waiver request is deemed to be granted unless it is denied within 60 days after it is received.
(c) Waivers will remain effective for 1 year at a time from the date of the request.
(d) If a hospice wishes to receive a 1-year extension, it must submit a request to CMS before the expiration of the waiver period, and certify that the conditions under which it originally requested the initial waiver have not changed since the initial waiver was granted.
A hospice must ensure that the services described in § 418.72 through § 418.78 are provided directly by the hospice or under arrangements made by the hospice as specified in § 418.100. These services must be provided in a manner consistent with current standards of practice.
Physical therapy services, occupational therapy services, and speech-language pathology services must be available, and when provided, offered in a manner consistent with accepted standards of practice.
(a) A hospice located in a non-urbanized area may submit a written request for a waiver of the requirement for providing physical therapy, occupational therapy, speech-language pathology, and dietary counseling services. The hospice may seek a waiver of the requirement that it make physical therapy, occupational therapy, speech-language pathology, and dietary counseling services (as needed) available on a 24-hour basis. The hospice may also seek a waiver of the requirement that it provide dietary counseling directly. The hospice must provide evidence that it has made a good faith effort to meet the requirements for these services before it seeks a waiver. CMS may approve a waiver application on the basis of the following criteria:
(1) The hospice is located in a non-urbanized area as determined by the Bureau of the Census.
(2) The hospice provides evidence that it had made a good faith effort to make available physical therapy, occupational therapy, speech-language pathology, and dietary counseling services on a 24-hour basis and/or to hire a dietary counselor to furnish services directly. This evidence must include the following:
(i) Copies of advertisements in local newspapers that demonstrate recruitment efforts.
(ii) Physical therapy, occupational therapy, speech-language pathology, and dietary counselor job descriptions.
(iii) Evidence that salary and benefits are competitive for the area.
(iv) Evidence of any other recruiting activities (for example, recruiting efforts at health fairs and contact discussions with physical therapy, occupational therapy, speech-language pathology, and dietary counseling service providers in the area).
(b) Any waiver request is deemed to be granted unless it is denied within 60 days after it is received.
(c) An initial waiver will remain effective for 1 year at a time from the date of the request.
(d) If a hospice wishes to receive a 1-year extension, it must submit a request to CMS before the expiration of the waiver period and certify that conditions under which it originally requested the waiver have not changed since the initial waiver was granted.
All hospice aide services must be provided by individuals who meet the personnel requirements specified in paragraph (a) of this section. Homemaker services must be provided by individuals who meet the personnel requirements specified in paragraph (j) of this section.
(a)
(i) A training program and competency evaluation as specified in paragraphs (b) and (c) of this section respectively.
(ii) A competency evaluation program that meets the requirements of paragraph (c) of this section.
(iii) A nurse aide training and competency evaluation program approved by the State as meeting the requirements of § 483.151 through § 483.154 of this chapter, and is currently listed in good standing on the State nurse aide registry.
(iv) A State licensure program that meets the requirements of paragraphs (b) and (c) of this section.
(2) A hospice aide is not considered to have completed a program, as specified in paragraph (a)(1) of this section, if, since the individual's most recent completion of the program(s), there has been a continuous period of 24 consecutive months during which none of the services furnished by the individual as described in § 409.40 of this chapter were for compensation. If there has been a 24-month lapse in furnishing services, the individual must complete another program, as specified in paragraph (a)(1) of this section, before providing services.
(b)
(2) A minimum of 16 hours of classroom training must precede a minimum of l6 hours of supervised practical training as part of the 75 hours.
(3) A hospice aide training program must address each of the following subject areas:
(i) Communication skills, including the ability to read, write, and verbally report clinical information to patients, care givers, and other hospice staff.
(ii) Observation, reporting, and documentation of patient status and the care or service furnished.
(iii) Reading and recording temperature, pulse, and respiration.
(iv) Basic infection control procedures.
(v) Basic elements of body functioning and changes in body function that must be reported to an aide's supervisor.
(vi) Maintenance of a clean, safe, and healthy environment.
(vii) Recognizing emergencies and the knowledge of emergency procedures and their application.
(viii) The physical, emotional, and developmental needs of and ways to work with the populations served by the hospice, including the need for respect for the patient, his or her privacy, and his or her property.
(ix) Appropriate and safe techniques in performing personal hygiene and grooming tasks, including items on the following basic checklist:
(A) Bed bath.
(B) Sponge, tub, and shower bath.
(C) Hair shampoo (sink, tub, and bed).
(D) Nail and skin care.
(E) Oral hygiene.
(F) Toileting and elimination.
(x) Safe transfer techniques and ambulation.
(xi) Normal range of motion and positioning.
(xii) Adequate nutrition and fluid intake.
(xiii) Any other task that the hospice may choose to have an aide perform. The hospice is responsible for training hospice aides, as needed, for skills not covered in the basic checklist, as described in paragraph (b)(3)(ix) of this section.
(4) The hospice must maintain documentation that demonstrates that the requirements of this standard are met.
(c)
(1) The competency evaluation must address each of the subjects listed in paragraph (b)(3) of this section. Subject areas specified under paragraphs (b)(3)(i), (b)(3)(iii), (b)(3)(ix), (b)(3)(x) and (b)(3)(xi) of this section must be
(2) A hospice aide competency evaluation program may be offered by any organization, except as described in paragraph (f) of this section.
(3) The competency evaluation must be performed by a registered nurse in consultation with other skilled professionals, as appropriate.
(4) A hospice aide is not considered competent in any task for which he or she is evaluated as unsatisfactory. An aide must not perform that task without direct supervision by a registered nurse until after he or she has received training in the task for which he or she was evaluated as “unsatisfactory,” and successfully completes a subsequent evaluation. A hospice aide is not considered to have successfully completed a competency evaluation if the aide has an “unsatisfactory” rating in more than one of the required areas.
(5) The hospice must maintain documentation that demonstrates the requirements of this standard are being met.
(d)
(1) In-service training may be offered by any organization, and must be supervised by a registered nurse.
(2) The hospice must maintain documentation that demonstrates the requirements of this standard are met.
(e)
(f)
(1) Had been of compliance with the requirements of § 484.36(a) and (b) of this chapter.
(2) Permitted an individual that does not meet the definition of a “qualified home health aide” as specified in § 484.36(a) of this chapter to furnish home health aide services (with the exception of licensed health professionals and volunteers).
(3) Had been subjected to an extended (or partial extended) survey as a result of having been found to have furnished substandard care (or for other reasons at the discretion of CMS or the State).
(4) Had been assessed a civil monetary penalty of $5,000 or more as an intermediate sanction.
(5) Had been found by CMS to have compliance deficiencies that endangered the health and safety of the home health agency's patients and had temporary management appointed to oversee the management of the home health agency.
(6) Had all or part of its Medicare payments suspended.
(7) Had been found by CMS or the State under any Federal or State law to have:
(i) Had its participation in the Medicare program terminated.
(ii) Been assessed a penalty of $5,000 or more for deficiencies in Federal or State standards for home health agencies.
(iii) Been subjected to a suspension of Medicare payments to which it otherwise would have been entitled.
(iv) Operated under temporary management that was appointed by a governmental authority to oversee the operation of the home health agency and to ensure the health and safety of the home health agency's patients.
(v) Been closed by CMS or the State, or had its patients transferred by the State.
(g)
(1) Hospice aides are assigned to a specific patient by a registered nurse that is a member of the interdisciplinary group. Written patient care instructions for a hospice aide must be prepared by a registered nurse who is responsible for the supervision of a hospice aide as specified under paragraph (h) of this section.
(2) A hospice aide provides services that are:
(i) Ordered by the interdisciplinary group.
(ii) Included in the plan of care.
(iii) Permitted to be performed under State law by such hospice aide.
(iv) Consistent with the hospice aide training.
(3) The duties of a hospice aide include the following:
(i) The provision of hands-on personal care.
(ii) The performance of simple procedures as an extension of therapy or nursing services.
(iii) Assistance in ambulation or exercises.
(iv) Assistance in administering medications that are ordinarily self-administered.
(4) Hospice aides must report changes in the patient's medical, nursing, rehabilitative, and social needs to a registered nurse, as the changes relate to the plan of care and quality assessment and improvement activities. Hospice aides must also complete appropriate records in compliance with the hospice's policies and procedures.
(h)
(i) No less frequently than every 14 days to assess the quality of care and services provided by the hospice aide and to ensure that services ordered by the hospice interdisciplinary group meet the patient's needs. The hospice aide does not have to be present during this visit.
(ii) If an area of concern is noted by the supervising nurse, then the hospice must make an on-site visit to the location where the patient is receiving care in order to observe and assess the aide while he or she is performing care.
(iii) If an area of concern is verified by the hospice during the on-site visit, then the hospice must conduct, and the hospice aide must complete a competency evaluation in accordance with § 418.76(c).
(2) A registered nurse must make an annual on-site visit to the location where a patient is receiving care in order to observe and assess each aide while he or she is performing care.
(3) The supervising nurse must assess an aide's ability to demonstrate initial and continued satisfactory performance in meeting outcome criteria that include, but is not limited to—
(i) Following the patient's plan of care for completion of tasks assigned to the hospice aide by the registered nurse.
(ii) Creating successful interpersonal relationships with the patient and family.
(iii) Demonstrating competency with assigned tasks.
(iv) Complying with infection control policies and procedures.
(v) Reporting changes in the patient's condition.
(i)
(1) Before the individual may furnish personal care services, the individual must be found competent by the State (if regulated by the State) to furnish those services. The individual only
(2) Services under the Medicaid personal care benefit may be used to the extent that the hospice would routinely use the services of a hospice patient's family in implementing a patient's plan of care.
(3) The hospice must coordinate its hospice aide and homemaker services with the Medicaid personal care benefit to ensure the patient receives the hospice aide and homemaker services he or she needs.
(j)
(1) An individual who meets the standards in § 418.202(g) and has successfully completed hospice orientation addressing the needs and concerns of patients and families coping with a terminal illness; or
(2) A hospice aide as described in § 418.76.
(k)
(1) Homemaker services must be coordinated and supervised by a member of the interdisciplinary group.
(2) Instructions for homemaker duties must be prepared by a member of the interdisciplinary group.
(3) Homemakers must report all concerns about the patient or family to the member of the interdisciplinary group who is coordinating homemaker services.
The hospice must use volunteers to the extent specified in paragraph (e) of this section. These volunteers must be used in defined roles and under the supervision of a designated hospice employee.
(a)
(b)
(c)
(d)
(1) The identification of each position that is occupied by a volunteer.
(2) The work time spent by volunteers occupying those positions.
(3) Estimates of the dollar costs that the hospice would have incurred if paid employees occupied the positions identified in paragraph (d)(1) of this section for the amount of time specified in paragraph (d)(2) of this section.
(e)
The hospice must organize, manage, and administer its resources to provide the hospice care and services to patients, caregivers and families necessary for the palliation and management of the terminal illness and related conditions.
(a)
The hospice must provide hospice care that—
(1) Optimizes comfort and dignity; and
(2) Is consistent with patient and family needs and goals, with patient needs and goals as priority.
(b)
(c)
(i) Nursing services.
(ii) Medical social services.
(iii) Physician services.
(iv) Counseling services, including spiritual counseling, dietary counseling, and bereavement counseling.
(v) Hospice aide, volunteer, and homemaker services.
(vi) Physical therapy, occupational therapy, and speech-language pathology services.
(vii) Short-term inpatient care.
(viii) Medical supplies (including drugs and biologicals) and medical appliances.
(2) Nursing services, physician services, and drugs and biologicals (as specified in § 418.106) must be made routinely available on a 24-hour basis 7 days a week. Other covered services must be available on a 24-hour basis when reasonable and necessary to meet the needs of the patient and family.
(d)
(e)
(1) Authorized by the hospice;
(2) Furnished in a safe and effective manner by qualified personnel; and
(3) Delivered in accordance with the patient's plan of care.
(f)
If a hospice operates multiple locations, it must meet the following requirements:
(1) Medicare approval.
(i) All hospice multiple locations must be approved by Medicare before providing hospice care and services to Medicare patients.
(ii) The multiple location must be part of the hospice and must share administration, supervision, and services with the hospice issued the certification number.
(iii) The lines of authority and professional and administrative control must be clearly delineated in the hospice's organizational structure and in practice, and must be traced to the location that issued the certification number.
(iv) The determination that a multiple location does or does not meet the definition of a multiple location, as set forth in this part, is an initial determination, as set forth in § 498.3.
(2) The hospice must continually monitor and manage all services
(g)
(1) A hospice must provide orientation about the hospice philosophy to all employees and contracted staff who have patient and family contact.
(2) A hospice must provide an initial orientation for each employee that addresses the employee's specific job duties.
(3) A hospice must assess the skills and competence of all individuals furnishing care, including volunteers furnishing services, and, as necessary, provide in-service training and education programs where required. The hospice must have written policies and procedures describing its method(s) of assessment of competency and maintain a written description of the in-service training provided during the previous 12 months.
The hospice must designate a physician to serve as medical director. The medical director must be a doctor of medicine or osteopathy who is an employee, or is under contract with the hospice. When the medical director is not available, a physician designated by the hospice assumes the same responsibilities and obligations as the medical director.
(a)
(i) A self-employed physician; or
(ii) A physician employed by a professional entity or physicians group. When contracting for medical director services, the contract must specify the physician who assumes the medical director responsibilities and obligations.
(b)
(1) The primary terminal condition;
(2) Related diagnosis(es), if any;
(3) Current subjective and objective medical findings;
(4) Current medication and treatment orders; and
(5) Information about the medical management of any of the patient's conditions unrelated to the terminal illness.
(c)
(d)
A clinical record containing past and current findings is maintained for each hospice patient. The clinical record must contain correct clinical information that is available to the patient's attending physician and hospice staff. The clinical record may be maintained electronically.
(a)
(1) The initial plan of care, updated plans of care, initial assessment, comprehensive assessment, updated comprehensive assessments, and clinical notes.
(2) Signed copies of the notice of patient rights in accordance with § 418.52 and election statement in accordance with § 418.24.
(3) Responses to medications, symptom management, treatments, and services.
(4) Outcome measure data elements, as described in § 418.54(e) of this subpart.
(5) Physician certification and recertification of terminal illness as required in § 418.22 and § 418.25 and described in § 418.102(b) and § 418.102(c) respectively, if appropriate.
(6) Any advance directives as described in § 418.52(a)(2).
(7) Physician orders.
(b)
(c)
(d)
(e)
(i) The hospice discharge summary; and
(ii) The patient's clinical record, if requested.
(2) If a patient revokes the election of hospice care, or is discharged from hospice in accordance with § 418.26, the hospice must forward to the patient's attending physician, a copy of—
(i) The hospice discharge summary; and
(ii) The patient's clinical record, if requested.
(3) The hospice discharge summary as required in paragraph (e)(1) and (e)(2) of this section must include—
(i) A summary of the patient's stay including treatments, symptoms and pain management.
(ii) The patient's current plan of care.
(iii) The patient's latest physician orders. and
(iv) Any other documentation that will assist in post-discharge continuity of care or that is requested by the attending physician or receiving facility.
(f)
Medical supplies and appliances, as described in § 410.36 of this chapter; durable medical equipment, as described in § 410.38 of this chapter; and drugs and biologicals related to the palliation and management of the terminal illness and related conditions, as identified in the hospice plan of care, must be provided by the hospice while the patient is under hospice care.
(a)
(1) The hospice must ensure that the interdisciplinary group confers with an individual with education and training in drug management as defined in hospice policies and procedures and State law, who is an employee of or
(2) A hospice that provides inpatient care directly in its own facility must provide pharmacy services under the direction of a qualified licensed pharmacist who is an employee of or under contract with the hospice. The provided pharmacist services must include evaluation of a patient's response to medication therapy, identification of potential adverse drug reactions, and recommended appropriate corrective action.
(b)
(1) Only a physician as defined by section 1861(r)(1) of the Act, or a nurse practitioner in accordance with the plan of care and State law, may order drugs for the patient.
(2) If the drug order is verbal or given by or through electronic transmission—
(i) It must be given only to a licensed nurse, nurse practitioner (where appropriate), pharmacist, or physician; and
(ii) The individual receiving the order must record and sign it immediately and have the prescribing person sign it in accordance with State and Federal regulations.
(c)
The hospice must—
(1) Obtain drugs and biologicals from community or institutional pharmacists or stock drugs and biologicals itself.
(2) The hospice that provides inpatient care directly in its own facility must:
(i) Have a written policy in place that promotes dispensing accuracy; and
(ii) Maintain current and accurate records of the receipt and disposition of all controlled drugs.
(d)
(1) The interdisciplinary group, as part of the review of the plan of care, must determine the ability of the patient and/or family to safely self-administer drugs and biologicals to the patient in his or her home.
(2) Patients receiving care in a hospice that provides inpatient care directly in its own facility may only be administered medications by the following individuals:
(i) A licensed nurse, physician, or other health care professional in accordance with their scope of practice and State law;
(ii) An employee who has completed a State-approved training program in medication administration; and
(iii) The patient, upon approval by the interdisciplinary group.
(e)
(1) Labeling. Drugs and biologicals must be labeled in accordance with currently accepted professional practice and must include appropriate usage and cautionary instructions, as well as an expiration date (if applicable).
(2) Disposing. (i) Safe use and disposal of controlled drugs in the patient's home. The hospice must have written policies and procedures for the management and disposal of controlled drugs in the patient's home. At the time when controlled drugs are first ordered the hospice must:
(A) Provide a copy of the hospice written policies and procedures on the management and disposal of controlled drugs to the patient or patient representative and family;
(B) Discuss the hospice policies and procedures for managing the safe use and disposal of controlled drugs with the patient or representative and the family in a language and manner that they understand to ensure that these parties are educated regarding the safe use and disposal of controlled drugs; and
(C) Document in the patient's clinical record that the written policies and procedures for managing controlled drugs was provided and discussed.
(ii) Disposal of controlled drugs in hospices that provide inpatient care directly. The hospice that provides inpatient care directly in its own facility must dispose of controlled drugs in compliance with the hospice policy and in accordance with State and Federal requirements. The hospice must maintain current and accurate records of the receipt and disposition of all controlled drugs.
(3) Storing. The hospice that provides inpatient care directly in its own facility must comply with the following additional requirements—
(i) All drugs and biologicals must be stored in secure areas. All controlled drugs listed in Schedules II, III, IV, and V of the Comprehensive Drug Abuse Prevention and Control Act of 1976 must be stored in locked compartments within such secure storage areas. Only personnel authorized to administer controlled drugs as noted in paragraph (d)(2) of this section may have access to the locked compartments; and
(ii) Discrepancies in the acquisition, storage, dispensing, administration, disposal, or return of controlled drugs must be investigated immediately by the pharmacist and hospice administrator and where required reported to the appropriate State authority. A written account of the investigation must be made available to State and Federal officials if required by law or regulation.
(f)
(1) The hospice must ensure that manufacturer recommendations for performing routine and preventive maintenance on durable medical equipment are followed. The equipment must be safe and work as intended for use in the patient's environment. Where a manufacturer recommendation for a piece of equipment does not exist, the hospice must ensure that repair and routine maintenance policies are developed. The hospice may use persons under contract to ensure the maintenance and repair of durable medical equipment.
(2) The hospice must ensure that the patient, where appropriate, as well as the family and/or other caregiver(s), receive instruction in the safe use of durable medical equipment and supplies. The hospice may use persons under contract to ensure patient and family instruction. The patient, family, and/or caregiver must be able to demonstrate the appropriate use of durable medical equipment to the satisfaction of the hospice staff.
(3) Hospices may only contract for durable medical equipment services with a durable medical equipment supplier that meets the Medicare DMEPOS Supplier Quality and Accreditation Standards at 42 CFR § 424.57.
Inpatient care must be available for pain control, symptom management, and respite purposes, and must be provided in a participating Medicare or Medicaid facility.
(a)
(1) A Medicare-certified hospice that meets the conditions of participation for providing inpatient care directly as specified in § 418.110.
(2) A Medicare-certified hospital or a skilled nursing facility that also meets the standards specified in § 418.110(b) and (e) regarding 24-hour nursing services and patient areas.
(b)
(1) Inpatient care for respite purposes must be provided by one of the following:
(i) A provider specified in paragraph (a) of this section.
(ii) A Medicare or Medicaid-certified nursing facility that also meets the standards specified in § 418.110(f).
(2) The facility providing respite care must provide 24-hour nursing services
(c)
(1) That the hospice supplies the inpatient provider a copy of the patient's plan of care and specifies the inpatient services to be furnished;
(2) That the inpatient provider has established patient care policies consistent with those of the hospice and agrees to abide by the palliative care protocols and plan of care established by the hospice for its patients;
(3) That the hospice patient's inpatient clinical record includes a record of all inpatient services furnished and events regarding care that occurred at the facility; that a copy of the discharge summary be provided to the hospice at the time of discharge; and that a copy of the inpatient clinical record is available to the hospice at the time of discharge;
(4) That the inpatient facility has identified an individual within the facility who is responsible for the implementation of the provisions of the agreement;
(5) That the hospice retains responsibility for ensuring that the training of personnel who will be providing the patient's care in the inpatient facility has been provided and that a description of the training and the names of those giving the training are documented; and
(6) A method for verifying that the requirements in paragraphs (c)(1) through (c)(5) of this section are met.
(d)
(e)
A hospice that provides inpatient care directly in its own facility must demonstrate compliance with all of the following standards:
(a)
(b)
(2) If at least one patient in the hospice facility is receiving general inpatient care, then each shift must include a registered nurse who provides direct patient care.
(c)
(1)
(i) The hospice must address real or potential threats to the health and safety of the patients, others, and property.
(ii) The hospice must have a written disaster preparedness plan in effect for managing the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care. The plan must be periodically reviewed and rehearsed with staff (including non-employee staff) with special emphasis placed on carrying out the procedures necessary to protect patients and others.
(2)
(i) The routine storage and prompt disposal of trash and medical waste;
(ii) Light, temperature, and ventilation/air exchanges throughout the hospice;
(iii) Emergency gas and water supply; and
(iv) The scheduled and emergency maintenance and repair of all equipment.
(d)
(i) The hospice must meet the provisions applicable to nursing homes of the 2000 edition of the Life Safety Code (LSC) of the National Fire Protection Association (NFPA). The Director of the Office of the Federal Register has approved the NFPA 101® 2000 edition of the Life Safety Code, issued January 14, 2000, for incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy of the code is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
(ii) Chapter 19.3.6.3.2, exception number 2 of the adopted edition of the LSC does not apply to hospices.
(2) In consideration of a recommendation by the State survey agency, CMS may waive, for periods deemed appropriate, specific provisions of the Life Safety Code which, if rigidly applied would result in unreasonable hardship for the hospice, but only if the waiver would not adversely affect the health and safety of patients.
(3) The provisions of the adopted edition of the Life Safety Code do not apply in a State if CMS finds that a fire and safety code imposed by State law adequately protects patients in hospices.
(4) Notwithstanding any provisions of the 2000 edition of the Life Safety Code to the contrary, a hospice may place alcohol-based hand rub dispensers in its facility if—
(i) Use of alcohol-based hand rub dispensers does not conflict with any State or local codes that prohibit or otherwise restrict the placement of alcohol-based hand rub dispensers in health care facilities;
(ii) The dispensers are installed in a manner that minimizes leaks and spills that could lead to falls;
(iii) The dispensers are installed in a manner that adequately protects against access by vulnerable populations; and
(iv) The dispensers are installed in accordance with chapter 18.3.2.7 or chapter 19.3.2.7 of the 2000 edition of the Life Safety Code, as amended by NFPA Temporary Interim Amendment 00-1(101), issued by the Standards Council of the National Fire Protection Association on April 15, 2004. The Director of the Office of the Federal
(e)
(1) The hospice must provide—
(i) Physical space for private patient and family visiting;
(ii) Accommodations for family members to remain with the patient throughout the night; and
(iii) Physical space for family privacy after a patient's death.
(2) The hospice must provide the opportunity for patients to receive visitors at any hour, including infants and small children.
(f)
(2) The hospice must accommodate a patient and family request for a single room whenever possible.
(3) Each patient's room must—
(i) Be at or above grade level;
(ii) Contain a suitable bed and other appropriate furniture for each patient;
(iii) Have closet space that provides security and privacy for clothing and personal belongings;
(iv) Accommodate no more than two patients and their family members;
(v) Provide at least 80 square feet for each residing patient in a double room and at least 100 square feet for each patient residing in a single room; and
(vi) Be equipped with an easily-activated, functioning device accessible to the patient, that is used for calling for assistance.
(4) For a facility occupied by a Medicare-participating hospice on December 2, 2008, CMS may waive the space and occupancy requirements of paragraphs (f)(2)(iv) and (f)(2)(v) of this section if it determines that—
(i) Imposition of the requirements would result in unreasonable hardship on the hospice if strictly enforced; or jeopardize its ability to continue to participate in the Medicare program; and
(ii) The waiver serves the needs of the patient and does not adversely affect their health and safety.
(g)
(h)
(1) Have an adequate supply of hot water at all times; and
(2) Have plumbing fixtures with control valves that automatically regulate the temperature of the hot water used by patients.
(i)
(j)
(k)
(l)
(1) Consistent with the patient's plan of care, nutritional needs, and therapeutic diet;
(2) Palatable, attractive, and served at the proper temperature; and
(3) Obtained, stored, prepared, distributed, and served under sanitary conditions.
(m)
(1) Restraint or seclusion may only be used when less restrictive interventions have been determined to be ineffective to protect the patient, a staff member, or others from harm.
(2) The type or technique of restraint or seclusion used must be the least restrictive intervention that will be effective to protect the patient, a staff member, or others from harm.
(3) The use of restraint or seclusion must be—
(i) In accordance with a written modification to the patient's plan of care; and
(ii) Implemented in accordance with safe and appropriate restraint and seclusion techniques as determined by hospice policy in accordance with State law.
(4) The use of restraint or seclusion must be in accordance with the order of a physician authorized to order restraint or seclusion by hospice policy in accordance with State law.
(5) Orders for the use of restraint or seclusion must never be written as a standing order or on an as needed basis (PRN).
(6) The medical director or physician designee must be consulted as soon as possible if the attending physician did not order the restraint or seclusion.
(7) Unless superseded by State law that is more restrictive—
(i) Each order for restraint or seclusion used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others may only be renewed in accordance with the following limits for up to a total of 24 hours:
(A) 4 hours for adults 18 years of age or older;
(B) 2 hours for children and adolescents 9 to 17 years of age; or
(C) 1 hour for children under 9 years of age; and
After 24 hours, before writing a new order for the use of restraint or seclusion for the management of violent or self-destructive behavior, a physician authorized to order restraint or seclusion by hospice policy in accordance with State law must see and assess the patient.
(ii) Each order for restraint used to ensure the physical safety of the non-violent or non-self-destructive patient may be renewed as authorized by hospice policy.
(8) Restraint or seclusion must be discontinued at the earliest possible time, regardless of the length of time identified in the order.
(9) The condition of the patient who is restrained or secluded must be
(10) Physician, including attending physician, training requirements must be specified in hospice policy. At a minimum, physicians and attending physicians authorized to order restraint or seclusion by hospice policy in accordance with State law must have a working knowledge of hospice policy regarding the use of restraint or seclusion.
(11) When restraint or seclusion is used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others, the patient must be seen face-to-face within 1 hour after the initiation of the intervention—
(i) By a—
(A) Physician; or
(B) Registered nurse who has been trained in accordance with the requirements specified in paragraph (n) of this section.
(ii) To evaluate—
(A) The patient's immediate situation;
(B) The patient's reaction to the intervention;
(C) The patient's medical and behavioral condition; and
(D) The need to continue or terminate the restraint or seclusion.
(12) States are free to have requirements by statute or regulation that are more restrictive than those contained in paragraph (m)(11)(i) of this section.
(13) If the face-to-face evaluation specified in § 418.110(m)(11) is conducted by a trained registered nurse, the trained registered nurse must consult the medical director or physician designee as soon as possible after the completion of the 1-hour face-to-face evaluation.
(14) All requirements specified under this paragraph are applicable to the simultaneous use of restraint and seclusion. Simultaneous restraint and seclusion use is only permitted if the patient is continually monitored—
(i) Face-to-face by an assigned, trained staff member; or
(ii) By trained staff using both video and audio equipment. This monitoring must be in close proximity to the patient.
(15) When restraint or seclusion is used, there must be documentation in the patient's clinical record of the following:
(i) The 1-hour face-to-face medical and behavioral evaluation if restraint or seclusion is used to manage violent or self-destructive behavior;
(ii) A description of the patient's behavior and the intervention used;
(iii) Alternatives or other less restrictive interventions attempted (as applicable);
(iv) The patient's condition or symptom(s) that warranted the use of the restraint or seclusion; and the patient's response to the intervention(s) used, including the rationale for continued use of the intervention.
(n)
(1)
(i) Before performing any of the actions specified in this paragraph;
(ii) As part of orientation; and
(iii) Subsequently on a periodic basis consistent with hospice policy.
(2)
(i) Techniques to identify staff and patient behaviors, events, and environmental factors that may trigger circumstances that require the use of a restraint or seclusion.
(ii) The use of nonphysical intervention skills.
(iii) Choosing the least restrictive intervention based on an individualized assessment of the patient's medical, or behavioral status or condition.
(iv) The safe application and use of all types of restraint or seclusion used in the hospice, including training in how to recognize and respond to signs of physical and psychological distress (for example, positional asphyxia).
(v) Clinical identification of specific behavioral changes that indicate that restraint or seclusion is no longer necessary.
(vi) Monitoring the physical and psychological well-being of the patient who is restrained or secluded, including but not limited to, respiratory and circulatory status, skin integrity, vital signs, and any special requirements specified by hospice policy associated with the 1-hour face-to-face evaluation.
(vii) The use of first aid techniques and certification in the use of cardiopulmonary resuscitation, including required periodic recertification.
(3)
(4)
(o)
(1) The hospice must report the following information to CMS:
(i) Each unexpected death that occurs while a patient is in restraint or seclusion.
(ii) Each unexpected death that occurs within 24 hours after the patient has been removed from restraint or seclusion.
(iii) Each death known to the hospice that occurs within 1 week after restraint or seclusion where it is reasonable to assume that use of restraint or placement in seclusion contributed directly or indirectly to a patient's death. “Reasonable to assume” in this context includes, but is not limited to, deaths related to restrictions of movement for prolonged periods of time, or death related to chest compression, restriction of breathing or asphyxiation.
(2) Each death referenced in this paragraph must be reported to CMS by telephone no later than the close of business the next business day following knowledge of the patient's death.
(3) Staff must document in the patient's clinical record the date and time the death was reported to CMS.
In addition to meeting the conditions of participation at § 418.10 through § 418.116, a hospice that provides hospice care to residents of a SNF/NF or ICF/MR must abide by the following additional standards.
(a)
(b)
(c)
(1) The manner in which the SNF/NF or ICF/MR and the hospice are to communicate with each other and document such communications to ensure that the needs of patients are addressed and met 24 hours a day.
(2) A provision that the SNF/NF or ICF/MR immediately notifies the hospice if—
(i) A significant change in a patient's physical, mental, social, or emotional status occurs;
(ii) Clinical complications appear that suggest a need to alter the plan of care;
(iii) A need to transfer a patient from the SNF/NF or ICF/MR, and the hospice makes arrangements for, and remains responsible for, any necessary continuous care or inpatient care necessary related to the terminal illness and related conditions; or
(iv) A patient dies.
(3) A provision stating that the hospice assumes responsibility for determining the appropriate course of hospice care, including the determination to change the level of services provided.
(4) An agreement that it is the SNF/NF or ICF/MR responsibility to continue to furnish 24 hour room and board care, meeting the personal care and nursing needs that would have been provided by the primary caregiver at home at the same level of care provided before hospice care was elected.
(5) An agreement that it is the hospice's responsibility to provide services at the same level and to the same extent as those services would be provided if the SNF/NF or ICF/MR resident were in his or her own home.
(6) A delineation of the hospice's responsibilities, which include, but are not limited to the following: Providing medical direction and management of the patient; nursing; counseling (including spiritual, dietary and bereavement); social work; provision of medical supplies, durable medical equipment and drugs necessary for the palliation of pain and symptoms associated with the terminal illness and related conditions; and all other hospice services that are necessary for the care of the resident's terminal illness and related conditions.
(7) A provision that the hospice may use the SNF/NF or ICF/MR nursing personnel where permitted by State law and as specified by the SNF/NF or ICF/MR to assist in the administration of prescribed therapies included in the plan of care only to the extent that the hospice would routinely use the services of a hospice patient's family in implementing the plan of care.
(8) A provision stating that the hospice must report all alleged violations involving mistreatment, neglect, or verbal, mental, sexual, and physical abuse, including injuries of unknown source, and misappropriation of patient property by anyone unrelated to the hospice to the SNF/NF or ICF/MR administrator within 24 hours of the hospice becoming aware of the alleged violation.
(9) A delineation of the responsibilities of the hospice and the SNF/NF or ICF/MR to provide bereavement services to SNF/NF or ICF/MR staff.
(d)
(1) The hospice plan of care must identify the care and services that are needed and specifically identify which provider is responsible for performing the respective functions that have been agreed upon and included in the hospice plan of care.
(2) The hospice plan of care reflects the participation of the hospice, the SNF/NF or ICF/MR, and the patient and family to the extent possible.
(3) Any changes in the hospice plan of care must be discussed with the patient or representative, and SNF/NF or ICF/MR representatives, and must be approved by the hospice before implementation.
(e)
(1) Designate a member of each interdisciplinary group that is responsible for a patient who is a resident of a SNF/NF or ICF/MR. The designated interdisciplinary group member is responsible for:
(i) Providing overall coordination of the hospice care of the SNF/NF or ICF/MR resident with SNF/NF or ICF/MR representatives; and
(ii) Communicating with SNF/NF or ICF/MR representatives and other health care providers participating in the provision of care for the terminal illness and related conditions and other conditions to ensure quality of care for the patient and family.
(2) Ensure that the hospice IDG communicates with the SNF/NF or ICF/MR medical director, the patient's attending physician, and other physicians participating in the provision of care to the patient as needed to coordinate the hospice care of the hospice patient with the medical care provided by other physicians.
(3) Provide the SNF/NF or ICF/MR with the following information:
(i) The most recent hospice plan of care specific to each patient;
(ii) Hospice election form and any advance directives specific to each patient;
(iii) Physician certification and recertification of the terminal illness specific to each patient;
(iv) Names and contact information for hospice personnel involved in hospice care of each patient;
(v) Instructions on how to access the hospice's 24-hour on-call system;
(vi) Hospice medication information specific to each patient; and
(vii) Hospice physician and attending physician (if any) orders specific to each patient.
(f)
(a)
(b)
The following qualifications must be met:
(1)
(2)
(3)
(i)(A) Has a Master of Social Work (MSW) degree from a school of social work accredited by the Council on Social Work Education; or
(B) Has a baccalaureate degree in social work from an institution accredited by the Council on Social Work Education; or a baccalaureate degree in psychology, sociology, or other field related to social work and is supervised by an MSW as described in paragraph (b)(3)(i)(A) of this section; and
(ii) Has 1 year of social work experience in a healthcare setting; or
(iii) Has a baccalaureate degree from a school of social work accredited by the Council on Social Work Education, is employed by the hospice before December 2, 2008, and is not required to be supervised by an MSW.
(4)
(i) The education and experience requirements for a Certificate of Clinical Competence in speech-language pathology granted by the American Speech-Language-Hearing Association.
(ii) The educational requirements for certification and is in the process of accumulating the supervised experience required for certification.
(5)
(i)(A) Is licensed or otherwise regulated, if applicable, as an occupational therapist by the State in which practicing, unless licensure does not apply;
(B) Graduated after successful completion of an occupational therapist education program accredited by the Accreditation Council for Occupational Therapy Education (ACOTE) of the American Occupational Therapy Association, Inc. (AOTA), or successor organizations of ACOTE; and
(C) Is eligible to take, or has successfully completed the entry-level certification examination for occupational therapists developed and administered by the National Board for Certification in Occupational Therapy, Inc. (NBCOT).
(ii) On or before December 31, 2009—
(A) Is licensed or otherwise regulated, if applicable, as an occupational therapist by the State in which practicing; or
(B) When licensure or other regulation does not apply—
(
(
(iii) On or before January 1, 2008—
(A) Graduated after successful completion of an occupational therapy program accredited jointly by the committee on Allied Health Education and Accreditation of the American Medical Association and the American Occupational Therapy Association; or
(B) Is eligible for the National Registration Examination of the American Occupational Therapy Association or the National Board for Certification in Occupational Therapy.
(iv) On or before December 31, 1977—
(A) Had 2 years of appropriate experience as an occupational therapist; and
(B) Had achieved a satisfactory grade on an occupational therapist proficiency examination conducted, approved, or sponsored by the U.S. Public Health Service.
(v) If educated outside the United States—
(A) Must meet both of the following:
(
(
(
(
(
(
(
(6)
(i) Meets all of the following:
(A) Is licensed or otherwise regulated, if applicable, as an occupational therapy assistant by the State in which practicing, unless licensure does apply.
(B) Graduated after successful completion of an occupational therapy assistant education program accredited by the Accreditation Council for Occupational Therapy Education (ACOTE) of the American Occupational Therapy Association, Inc. (AOTA) or its successor organizations.
(C) Is eligible to take or successfully completed the entry-level certification examination for occupational therapy assistants developed and administered by the National Board for Certification in Occupational Therapy, Inc. (NBCOT).
(ii) On or before December 31, 2009—
(A) Is licensed or otherwise regulated as an occupational therapy assistant, if applicable, by the State in which practicing; or any qualifications defined by the State in which practicing, unless licensure does not apply; or
(B) Must meet both of the following:
(
(
(iii) After December 31, 1977 and on or before December 31, 2007—
(A) Completed certification requirements to practice as an occupational therapy assistant established by a credentialing organization approved by the American Occupational Therapy Association; or
(B) Completed the requirements to practice as an occupational therapy assistant applicable in the State in which practicing.
(iv) On or before December 31, 1977—
(A) Had 2 years of appropriate experience as an occupational therapy assistant; and
(B) Had achieved a satisfactory grade on an occupational therapy assistant proficiency examination conducted, approved, or sponsored by the U.S. Public Health Service.
(v) If educated outside the United States, on or after January 1, 2008—
(A) Graduated after successful completion of an occupational therapy assistant education program that is accredited as substantially equivalent to occupational therapist assistant entry level education in the United States by—
(
(
(
(
(
(7)
(i) Graduated after successful completion of a physical therapist education program approved by one of the following:
(A) The Commission on Accreditation in Physical Therapy Education (CAPTE).
(B) Successor organizations of CAPTE.
(C) An education program outside the United States determined to be substantially equivalent to physical therapist entry level education in the United States by a credentials evaluation organization approved by the American Physical Therapy Association or an organization identified in 8 CFR 212.15(e) as it relates to physical therapists.
(D) Passed an examination for physical therapists approved by the State in which physical therapy services are provided.
(ii) On or before December 31, 2009—
(A) Graduated after successful completion of a physical therapy curriculum approved by the Commission on Accreditation in Physical Therapy Education (CAPTE); or
(B) Meets both of the following:
(
(
(iii) Before January 1, 2008—
(A) Graduated from a physical therapy curriculum approved by one of the following:
(
(
(
(iv) On or before December 31, 1977 was licensed or qualified as a physical therapist and meets both of the following:
(A) Has 2 years of appropriate experience as a physical therapist.
(B) Has achieved a satisfactory grade on a proficiency examination conducted, approved, or sponsored by the U.S. Public Health Service.
(v) Before January 1, 1966—
(A) Was admitted to membership by the American Physical Therapy Association;
(B) Was admitted to registration by the American Registry of Physical Therapists; and
(C) Graduated from a physical therapy curriculum in a 4-year college or university approved by a State department of education.
(vi) Before January 1, 1966 was licensed or registered, and before January 1, 1970, had 15 years of fulltime experience in the treatment of illness or injury through the practice of physical therapy in which services were rendered under the order and direction of attending and referring doctors of medicine or osteopathy.
(vii) If trained outside the United States before January 1, 2008, meets the following requirements:
(A) Was graduated since 1928 from a physical therapy curriculum approved in the country in which the curriculum was located and in which there is a member organization of the World Confederation for Physical Therapy.
(B) Meets the requirements for membership in a member organization of the World Confederation for Physical Therapy.
(8)
(i) Graduated from a physical therapist assistant curriculum approved by the Commission on Accreditation in Physical Therapy Education of the American Physical Therapy Association; or if educated outside the United States or trained in the United States military, graduated from an education program determined to be substantially equivalent to physical therapist assistant entry level education in the United States by a credentials evaluation organization approved by the American Physical Therapy Association or identified at 8 CFR 212.15(e); and
(ii) Passed a national examination for physical therapist assistants.
(A) On or before December 31, 2009, meets one of the following:
(
(
(
(
(c)
(1)
(2)
(d)
(2) Criminal background checks must be obtained in accordance with State requirements. In the absence of State requirements, criminal background checks must be obtained within three months of the date of employment for all states that the individual has lived or worked in the past 3 years.
The hospice and its staff must operate and furnish services in compliance with all applicable Federal, State, and local laws and regulations related to the health and safety of patients. If State or local law provides for licensing of hospices, the hospice must be licensed.
(a)
(b)
(2) If the hospice chooses to refer specimens for laboratory testing to a reference laboratory, the reference laboratory must be certified in the appropriate specialties and subspecialties of services in accordance with the applicable requirements of part 493 of this chapter.
Securities and Exchange Commission.
Final rule amendments.
The Securities and Exchange Commission is amending its rules to reflect the reorganization of its former five regional and six district offices into eleven regional offices reporting directly to SEC Headquarters. The Commission also is correcting addresses appearing in its rules.
Effective Date: June 5, 2008.
Stephen Jung, (202) 551-5162, Assistant General Counsel, Office of the General Counsel; Michael Bloise, (202) 551-5116, Senior Counsel, Office of the General Counsel, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549.
The Commission is amending 17 CFR parts 200, 201, 202, 203, 209, 230, 232, 240, 249, 249b, 260, 270, 274, 275, and 279.
On March 30, 2007, the Chairman of the Securities and Exchange Commission announced a new structure for the Commission's regional and district offices and changes to the designation of the offices and their chief supervisory personnel.
As a result of the reorganization, the former structure, in which there were six district offices reporting to five regional offices that, in turn, reported to Commission headquarters, was replaced by a new structure in which there are eleven regional offices, each reporting directly to Commission headquarters. Each regional office is now designated by the name of the city in which it is located, as follows: Atlanta Regional Office, Boston Regional Office, Chicago Regional Office, Denver Regional Office, Fort Worth Regional Office, Los Angeles Regional Office, Miami Regional Office, New York Regional Office, Philadelphia Regional Office, Salt Lake City Regional Office, and San Francisco Regional Office.
Pursuant to the reorganization, the title “District Administrator” was discontinued, and the heads of all of the regional offices are now called “Regional Directors.” The term “Regional Director” also replaced the term “District Administrator” in the titles of subordinate managers in the regional offices. The regional offices report, on enforcement matters, to the Deputy Director of the Division of Enforcement who is responsible for regional office enforcement matters and, on examination matters, to the Director of the Office of Compliance Inspections and Examinations. The Director of Regional Office Operations continues to oversee regional office operational and management issues.
To reflect this reorganization, the Commission is amending certain of its rules to delete the term “district office” or replace it with the term “regional office,” as appropriate. Likewise, the Commission is amending certain of its rules to delete the term “District Administrator” or replace it with the term “Regional Director,” as appropriate. The Commission also is removing rules that describe the duties of District Administrators and delegate functions to these persons. In addition, because a number of Commission offices have relocated since the adoption of the current rules, the Commission is amending its rules to update the addresses that appear in its rules for all of its offices.
The rule amendments also update the geographic allocation of examination and enforcement jurisdiction to each Regional Director. This geographic allocation also determines where brokers, dealers, transfer agents, clearing agents, registered securities associations, investment advisers, and others must file reports that are required to be filed in regional offices. These registrants should note changes in the geographic allocation resulting from the reorganization.
The Commission has determined that these amendments to its rules relate solely to the agency's organization, procedure, or practice. Therefore, the provisions of the Administrative Procedure Act (“APA”) regarding notice of proposed rulemaking and opportunity for public participation are not applicable.
The Commission is sensitive to the costs and benefits imposed by its rules. The rule amendments the Commission is adopting today update the Commission's rules to reflect the reorganization of the Commission's regional offices. The amendments also update addresses for the Commission's offices that appear in the Commission's rules.
The Commission believes that the reorganization of the Commission's regional offices will produce the benefit of facilitating the offices' cooperation with state and federal regulators, law enforcement agencies and consumer groups at the local level to better protect investors no matter where they live or with whom they invest. The reorganization also should help eliminate the potential for redundancy and overlap in the Commission's inspection and enforcement procedures. Updating addresses in the Commission's rules will help registrants, investors, and others avoid misdirecting their communications with the Commission. The Commission does not believe that the rule amendments will impose any costs on non-agency parties, or that if there are any such costs, they are negligible.
Section 23(a)(2) of the Securities Exchange Act of 1934 (“Exchange Act”) requires the Commission, in making rules pursuant to any provision of the Exchange Act, to consider among other matters the impact any such rule would have on competition. The Commission does not believe that the amendments that the Commission is adopting today will have any impact on competition.
The Commission is adopting amendments to 17 CFR parts 200, 201, 202, 203, 209, 229, 230, 232, 239, 240, 249, 249b, 260, 269, 270, 274, 275, and 279 pursuant to 15 U.S.C. 77s, 78d-1, 78w, 80a-37, 80b-11, 7202, and the authorities set forth therein.
Administrative practice and procedure, Authority delegations (Government agencies), Classified information, Environmental impact statements, Equal employment opportunity, Freedom of information, Government employees, Organization and functions (Government agencies), Privacy, Reporting and recordkeeping requirements.
Administrative practice and procedure.
Administrative practice and procedure, Securities.
Administrative practice and procedure, Investigations, Securities.
Administrative practice and procedure.
Reporting and recordkeeping requirements, Securities.
Brokers, Reporting and recordkeeping requirements, Securities.
Reporting and recordkeeping requirements.
Investment companies, Reporting and recordkeeping requirements, Securities.
Reporting and recordkeeping requirements.
15 U.S.C. 77o, 77s, 77sss, 78d, 78d-1, 78d-2, 78w, 78
Sections 200.27 and 200.30-6 are also issued under 15 U.S.C. 77e, 77f, 77g, 77h, 77j, 77q, 77u, 78e, 78g, 78h, 78i, 78k, 78m, 78o, 78o-4, 78q, 78q-1, 78t-1, 78u, 77hhh, 77uuu, 80a-41, 80b-5, and 80b-9.
Section 200.30-3 is also issued under 15 U.S.C. 78b, 78d, 78f, 78k-1, 78q, 78s, and 78eee.
(a)(1) Division and Office Heads in the Headquarters Office (100 F Street, NE., Washington, DC 20549) have Commission-wide responsibility to the Commission for the overall development, policy and technical guidance, and policy direction of the operating programs under their jurisdiction.
(2) Each Regional Director is responsible for the direction and supervision of his or her work force and for the execution of all programs in his or her office's region as shown in paragraph (b) of this section, in accordance with established policy, and reports, on enforcement matters, to the Deputy Director of the Division of Enforcement who is responsible for Regional Office enforcement matters and, on examination matters, to the Director of the Office of Compliance Inspections and Examinations. The Director of Regional Office Operations interacts with the Regional Directors and their staff on operational and administrative/management issues and serves as their representative in the Commission's Washington Headquarters in those areas.
(b) Regional Directors of the Commission.
Atlanta Regional Office: Alabama, Georgia, North Carolina, South Carolina, and Tennessee—Regional Director, 3475 Lenox Road, NE., Suite 1000, Atlanta, GA 30326-1232.
Boston Regional Office: Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont—Regional Director, 33 Arch Street, 23rd Floor, Boston, MA 02110-1424.
Chicago Regional Office: Kentucky, Illinois, Indiana, Iowa, Michigan, Minnesota, Missouri, Ohio, and Wisconsin—Regional Director, 175 West Jackson Boulevard, Suite 900, Chicago, IL 60604-2908.
Denver Regional Office: Colorado, Kansas, Nebraska, New Mexico, North Dakota, South Dakota, and Wyoming—Regional Director, 1801 California Street, Suite 1500, Denver, CO 80202-2656.
Fort Worth Regional Office: Arkansas, Kansas (for certain purposes), Oklahoma, and Texas—Regional Director, Burnett Plaza, Suite 1900, 801 Cherry Street, Unit #18, Fort Worth, TX 76102-6882.
Los Angeles Regional Office: Arizona, Southern California (zip codes 93599 and below, except 93200-93299), Guam, Hawaii, and Nevada—Regional Director, 5670 Wilshire Boulevard, 11th Floor, Los Angeles, CA 90036-3648.
Miami Regional Office: Florida, Louisiana, Mississippi, Puerto Rico, and the Virgin Islands—Regional Director, 801 Brickell Avenue, Suite 1800, Miami, FL 33131-4901.
New York Regional Office: New York and New Jersey—Regional Director, 3 World Financial Center, Suite 400, New York, NY 10281-1022.
Philadelphia Regional Office: Delaware, District of Columbia, Maryland, Pennsylvania, Virginia, and West Virginia—Regional Director, 701 Market Street, Suite 2000, Philadelphia, PA 19106-1532.
Salt Lake City Regional Office: Utah—Regional Director, 15 W. South Temple Street, Suite 1800, Salt Lake City, UT 84101-1573.
San Francisco Regional Office: Alaska, Northern California (zip codes 93600 and up, plus 93200-93299), Idaho, Montana, Oregon, and Washington—Regional Director, 44 Montgomery Street, Suite 2600, San Francisco, CA 94104-4716.
(c) The geographic allocation set forth in paragraph (b) of this section determines where registered brokers, dealers, transfer agents, clearing agents, registered securities associations, investment advisers, and others as designated in this chapter must file reports required to be filed in regional offices.
Each Regional Director is responsible for executing the Commission's programs within his or her geographic region as set forth in § 200.11(b), subject to review, on enforcement matters, by the Deputy Director of the Division of Enforcement who is responsible for Regional Office enforcement matters and, on examination matters, by the Director of the Office of Compliance Inspections and Examinations, and subject to policy direction and review by the other Division Directors, the General Counsel, and the Chief Accountant. The Regional Directors' responsibilities include particularly the investigation of transactions in securities on national securities exchanges, in the over-the-counter market, and in distribution to the public; the examination of members of national securities exchanges and registered brokers and dealers, transfer agents, investment advisers and investment companies, including the examination of reports filed under § 240.17a-5 of this chapter; the prosecution of injunctive actions in U.S. District Courts and administrative proceedings before Administrative Law Judges; the rendering of assistance to U.S. Attorneys in criminal cases; and the making of the Commission's facilities more readily available to the public in that area. In addition, the Regional Director of the New York Regional Office is responsible for the Commission's participation in cases under chapters 9 and 11 of the Bankruptcy Code in Connecticut, Maine, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, and Vermont; the Regional Director of the Atlanta Regional Office is responsible for such participation in Alabama, Delaware, District of Columbia, Florida, Georgia, Louisiana, Maryland, Mississippi, North Carolina, Puerto Rico, South Carolina, Tennessee, Virgin Islands, Virginia, and West Virginia; the Regional Director of the Chicago Regional Office is responsible for such participation in Arkansas, Colorado, Illinois, Indiana, Iowa, Kansas, Kentucky, Michigan, Minnesota, Missouri, Nebraska, New Mexico, North Dakota, Ohio, Oklahoma, South Dakota, Texas, Wisconsin, and Wyoming; and the Regional Director of the Los Angeles Regional Office is responsible for such participation in Alaska, Arizona, California, Guam, Hawaii, Idaho, Montana, Nevada, Oregon, Utah, and Washington.
5 U.S.C. 552, as amended, 15 U.S.C. 77f(d), 77s, 77ggg(a), 77sss, 78m(F)(3), 78w, 80a-37, 80a-44(a), 80a-44(b), 80b-10(a), and 80b-11.
The revisions read as follow:
(c)(1)
(i) The public reference room in Washington, DC has available for public inspection all of the publicly available records of the Commission as described in paragraph (a) of this section. Upon request, and only when suitable arrangements can be made with respect to the transportation, storage, and inspection of records, records may be sent to any other Commission office for inspection at that office, if the records are not needed by the Commission or the staff in connection with the performance of official duties. When the records are sent to another office at the request of a member of the public, the requestor shall be charged all costs incurred by the Commission in transporting the records.
(ii) All regional offices of the Commission have available for public examination the materials set forth in paragraph (a)(2) of this section and the
(iii) The addresses of the Commission's regional offices are:
Atlanta Regional Office—3475 Lenox Road, NE., Suite 1000, Atlanta, GA 30326-1232. Office hours—9 a.m. to 5:30 p.m. E.T.
Boston Regional Office—33 Arch Street, 23rd Floor, Boston, MA 02110-1424. Office hours—9 a.m. to 5:30 p.m. E.T.
Chicago Regional Office—175 West Jackson Boulevard, Suite 900, Chicago, IL 60604-2908. Office hours—8:45 a.m. to 5:15 p.m. C.T.
Denver Regional Office—1801 California Street, Suite 1500, Denver, CO 80202-2656. Office hours—8 a.m. to 4:30 p.m. M.T.
Fort Worth Regional Office—Burnett Plaza, Suite 1900, 801 Cherry Street, Unit #18, Fort Worth, TX 76102-6882. Office hours—8:30 a.m. to 5 p.m. C.T.
Los Angeles Regional Office—5670 Wilshire Boulevard, 11th Floor, Los Angeles, CA 90036-3648. Office hours—8:30 a.m. to 5 p.m. P.T.
Miami Regional Office—801 Brickell Avenue, Suite 1800, Miami, FL 33131-4901. Office hours—9 a.m. to 5:30 p.m. E.T.
New York Regional Office—3 World Financial Center, Suite 400, New York, NY 10281-1022. Office hours—9 a.m. to 5:30 p.m. E.T.
Philadelphia Regional Office—701 Market Street, Suite 2000, Philadelphia, PA 19106-1532. Office hours—9 a.m. to 5:30 p.m. E.T.
Salt Lake City Regional Office—15 W. South Temple Street, Suite 1800, Salt Lake City, UT 84101-1573. Office hours—8 a.m. to 4:30 p.m. M.T.
San Francisco Regional Office—44 Montgomery Street, Suite 2600, San Francisco, CA 94104-4716. Office hours—8:30 a.m. to 5 p.m. P.T.
(d) * * *
(6) * * *
(ii) The appeal must be mailed to the Office of Freedom of Information and Privacy Act Operations, SEC, 100 F Street, NE., Washington, DC 20549, and a copy of it must be mailed to the General Counsel, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549.
15 U.S.C. 77s, 78d, 78d-1, 78w, 77sss, 80a-37, 80b-11; Reorganization Plan No. 10 of 1950 (15 U.S.C. 78d nt).
5 U.S.C. 552a(f), unless otherwise noted.
The revision reads as follows:
(a) * * *
(2)
Atlanta Regional Office—3475 Lenox Road, NE., Suite 1000, Atlanta, GA 30326-1232. Office hours—9 a.m. to 5:30 p.m. E.T.
Boston Regional Office—33 Arch Street, 23rd Floor, Boston, MA 02110-1424. Office hours—9 a.m. to 5:30 p.m. E.T.
Chicago Regional Office—175 West Jackson Boulevard, Suite 900, Chicago, IL 60604-2908. Office hours—8:45 a.m. to 5:15 p.m. C.T.
Denver Regional Office—1801 California Street, Suite 1500, Denver, CO 80202-2656. Office hours—8 a.m. to 4:30 p.m. M.T.
Fort Worth Regional Office—Burnett Plaza, Suite 1900, 801 Cherry Street, Unit #18, Fort Worth, TX 76102-6882. Office hours—8:30 a.m. to 5 p.m. C.T.
Los Angeles Regional Office—5670 Wilshire Boulevard, 11th Floor, Los Angeles, CA 90036-3648. Office hours—8:30 a.m. to 5 p.m. P.T.
Miami Regional Office—801 Brickell Avenue, Suite 1800, Miami, FL 33131-4901. Office hours—9 a.m. to 5:30 p.m. E.T.
New York Regional Office—3 World Financial Center, Suite 400, New York, NY 10281-1022. Office hours—9 a.m. to 5:30 p.m. E.T.
Philadelphia Regional Office—701 Market Street, Suite 2000, Philadelphia, PA 19106-1532. Office hours—9 a.m. to 5:30 p.m. E.T.
Salt Lake City Regional Office—15 W. South Temple Street, Suite 1800, Salt Lake City, UT 84101-1573. Office hours—8 a.m. to 4:30 p.m. M.T.
San Francisco Regional Office—44 Montgomery Street, Suite 2600, San Francisco, CA 94104-4716. Office hours—8:30 a.m. to 5 p.m. P.T.
None of the Commission's offices is open on Saturday, Sunday or the following legal holidays: New Year's Day, Martin Luther King, Jr.'s Birthday, Presidents' Day, Memorial Day, Independence Day, Labor Day, Veterans' Day, Columbus Day, Thanksgiving Day, and Christmas Day.
Sec. 19, Securities Act of 1933, as amended, 48 Stat. 84, 15 U.S.C. 77s. E.O. 12356, (47 FR 14874, Apr. 6, 1982). Information Security Oversight Office Directive No. 1 (47 FR 27836, June 25, 1982).
15 U.S.C. 78w(a)(2).
29 U.S.C. 794.
15 U.S.C. 77s, 77sss, 78w, 80a-37, 80b-11; E.O. 11222, 3 CFR, 1964-1965 Comp., p.36; 5 CFR 735.104, unless otherwise noted.
(c) * * *
(2) * * *
(v) Regional Offices
(A) Directors
(B) Associate Directors
(C) Assistant Directors
15 U.S.C. 77s, 77sss, 78w, 78x, 80a-37, and 80b-11; 5 U.S.C. 504(c)(1).
15 U.S.C. 78u-1 and 78w.
15 U.S.C. 77s, 77t, 77sss, 77uuu, 78d-1, 78u, 78w, 78
Section 202.5 is also issued under sec. 20, 48 Stat. 86, sec. 21, 48 Stat. 899, sec. 18, 49 Stat. 831, sec. 321, 53 Stat. 1174, sec. 1, 76 Stat. 394, 15 U.S.C. 77t, 77uuu, 78d-1, 78u, 80a-4
Section 202.9 is also issued under sec. 223, 110 Stat. 859 (Mar. 29, 1996).
15 U.S.C. 77s, 77sss, 78w, 80a-37, and 80b-11, unless otherwise noted.
15 U.S.C. 77h-1, 77u, 78u-2, 78u-3, 78v, 78w, 80a-9, 80a-37, 80a-38, 80a-39, 80a-40, 80a-41, 80a-44, 80b-3, 80b-9, 80b-11, and 80b-12, unless otherwise noted.
15 U.S.C. 77b, 77c, 77d, 77f, 77g, 77h, 77j, 77r, 77s, 77z-3, 77sss, 78c, 78d, 78j, 78
15 U.S.C. 77f, 77g, 77h, 77j, 77s(a), 77z-3, 77sss(a), 78c(b), 78
15 U.S.C. 77c, 77d, 77g, 77j, 77s, 77z-2, 77z-3, 77eee, 77ggg, 77nnn, 77sss, 77ttt, 78c, 78d, 78e, 78f, 78g, 78i, 78j, 78j-1, 78k, 78k-1, 78
15 U.S.C. 78a
15 U.S.C. 78a
15 U.S.C. 77eee, 77ggg, 77nnn, 77sss, 78
15 U.S.C. 80a-1
15 U.S.C. 77f, 77g, 77h, 77j, 77s, 78c(b), 78
15 U.S.C. 80b-2(a)(11)(G), 80b-2(a)(17), 80b-3, 80b-4, 80b-4a, 80b-6(4), 80b-6a, and 80b-11, unless otherwise noted.
The Investment Advisers Act of 1940, 15 U.S.C. 80b-1
By the Commission.