Federal Crop Insurance Corporation
Grain Inspection, Packers and Stockyards Administration
National Agricultural Statistics Service
Rural Utilities Service
Engineers Corps
Committee for Purchase From People Who Are Blind or Severely Disabled
Economic Analysis Bureau
Industry and Security Bureau
National Oceanic and Atmospheric Administration
Patent and Trademark Office
Engineers Corps
Energy Efficiency and Renewable Energy Office
Centers for Medicare & Medicaid Services
Food and Drug Administration
Health Resources and Services Administration
Coast Guard
Customs and Border Protection Bureau
Federal Emergency Management Agency
Fish and Wildlife Service
Land Management Bureau
Employment Standards Administration
Occupational Safety and Health Administration
National Agricultural Statistics Service
Committee for the Implementation of Textile Agreements
Federal Aviation Administration
Federal Motor Carrier Safety Administration
Federal Transit Administration
National Highway Traffic Safety Administration
Research and Special Programs Administration
Surface Transportation Board
Internal Revenue Service
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws.
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Federal Crop Insurance Corporation, USDA.
Final rule.
The Federal Crop Insurance Corporation (FCIC) finalizes amendments to the Apple Crop Insurance Provisions. The intended effects of this action are to provide policy changes and clarify existing policy provisions to better meet the needs of the insured and to restrict the effect of the current Apple Crop Insurance Regulations to the 2004 and prior crop years.
Effective August 30, 2004.
Gary Johnson, Risk Management Specialist, Research and Development, Product Development Division, Risk Management Agency, United States Department of Agriculture, 6501 Beacon Drive, Stop 0812, Room 426, Kansas City, MO, 64133-4676, telephone (816) 926-7730.
This rule has been determined to be not-significant for the purposes of Executive Order 12866 and, therefore, it has not been reviewed by the Office of Management and Budget (OMB).
Pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the collections of information in this rule have been approved by OMB under control number 0563-0053 through February 28, 2005.
In its efforts to comply with GPEA, FCIC requires all insurance providers delivering the crop insurance program to make all insurance documents available electronically and to permit producers to transact business electronically. Further, to the maximum extent practicable, FCIC transacts its business with insurance providers electronically.
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. This rule contains no Federal mandates (under the regulatory provisions of title II of the UMRA) for State, local, and tribal governments or the private sector. Therefore, this rule is not subject to the requirements of sections 202 and 205 of UMRA.
It has been determined under section 1(a) of Executive Order 13132, Federalism, that this rule does not have sufficient implications to warrant consultation with the States. The provisions contained in this rule will not have a substantial direct effect on States, or on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
FCIC certifies that this regulation will not have a significant economic impact on a substantial number of small entities. Program requirements for the Federal crop insurance program are the same for all producers regardless of the size of their farming operation. For instance, all producers are required to submit an application and acreage report to establish their insurance guarantees and compute premium amounts, or a notice of loss and production information to determine an indemnity payment in the event of an insured cause of crop loss. Whether a producer has 10 acres or 1000 acres, there is no difference in the kind of information collected. To ensure crop insurance is available to small entities, the Federal Crop Insurance Act authorizes FCIC to waive collection of administrative fees from limited resource farmers. FCIC believes this waiver helps to ensure small entities are given the same opportunities to manage their risks through the use of crop insurance. A Regulatory Flexibility Analysis has not been prepared since this regulation does not have an impact on small entities, and, therefore, this regulation is exempt from the provisions of the Regulatory Flexibility Act (5 U.S.C. 605).
This program is listed in the Catalog of Federal Domestic Assistance under No. 10.450.
This program is not subject to the provisions of Executive Order 12372, which require intergovernmental consultation with State and local officials. See the Notice related to 7 CFR part 3015, subpart V, published at 48 FR 29115, June 24, 1983.
This rule has been reviewed in accordance with Executive Order 12988 on civil justice reform. The provisions of this rule will not have a retroactive effect. The provisions of this rule will preempt State and local laws to the extent such State and local laws are inconsistent herewith. With respect to any direct action taken by FCIC under the terms of the crop insurance policy, the administrative appeal provisions published at 7 CFR part 11 and 7 CFR part 400, subpart J for the informal administrative review process of good farming practices, as applicable, must be exhausted before any action for judicial review of any determination or action by FCIC may be brought.
This action is not expected to have a significant impact on the quality of the human environment, health, and safety. Therefore, neither an Environmental Assessment nor an Environmental Impact Statement is needed.
On March 29, 2004, FCIC published a notice of proposed rulemaking in the
“(b) That are grown on tree varieties that are adapted to the area and have produced at least an average of:
“(1) 10 bins of apples per acre in Area A;
“(2) 150 bushels of apples per acre in Area B;
“(3) 200 bushels of apples per acre in Area C.”
“(1) For the year of application, coverage begins:
“(a) In California, February 1 * * *
“(b) In all other states, November 21* * *
“However, if your application is received by us less than 20 days prior to this date, insurance will attach on the 20th day * * *”
“(3) The calendar date for the end of the insurance period for each crop year is:
“(a) November 5 in California, unless otherwise specified in the Special Provisions;
“(b) November 20 in all other states.”
In addition to the changes described above, FCIC has made minor editorial and the following changes:
1. Removed section 3(d) because it no longer is applicable and has been removed from the Basic Provisions.
2. Revised section 6 to specify that blocks of apple acreage grown for processing are not eligible for the Optional Coverage for Fresh Quality
Good cause is shown to make this rule effective less than 30 days after publication in the
With respect to the provisions of this rule, it would be contrary to the public interest to delay implementation of improved insurance benefits until the 2006 crop year. The public interest is served by improving the insurance product as follows: (1) Revising Fresh Fruit Option B (now the Optional Coverage for Fresh Fruit Quality Adjustment) to provide coverage for all perils so that producers receive adequate coverage, thereby stabilizing the farm economy and reducing the need for ad hoc disaster payment; (2) eliminating several options under the current program, which will eliminate program complexity and confusion; (3) incorporating sunburn caused by excessive sun as an insured cause of loss under the Basic Apple Crop Provisions to provide additional coverage, thereby stabilizing the farm economy and reducing the need for ad hoc disaster payment; and (4) providing simplification and clarity to the apple crop insurance program.
If FCIC is required to delay the implementation of this rule 30 days after the date it is published, the provisions of this rule could not be implemented until the 2006 crop year. This would mean the affected producers would be without the benefits described above for an additional year.
For the reasons stated above, good cause exists to make these policy changes less than 30 days after the date of publication in the
Crop insurance, Reporting and recordkeeping requirements.
7 U.S.C. 1506(l) and 1506(p).
The Apple Crop Insurance Provisions for the 2005 and succeeding crop years are as follows:
1.
(1) With respect to losses calculated under section 12 only, the percentage of fresh or processing apple production that fails to grade U.S. No. 1 Processing or better in accordance with the grade standards, within each lot, bin, bushel or box, as applicable, due to an insurable cause of loss; or
(2) With respect to losses calculated under section 14, the percentage of fresh apple production that fails to grade U.S. Fancy or better in accordance with the grade standards, within each lot, bin, bushel, or box, as applicable, due to an insurable cause of loss.
(1) That is sold, or could be sold, for consumption without undergoing any change in its basic form, such as peeling, juicing, crushing, etc.; and
(2) From acreage that is reported as fresh apples on the acreage report.
(1) That is sold after it had undergone a change to its basic structure such as peeling, juicing, crushing, etc.; and
(2) From acreage designated as processing apples on the acreage report.
2.
(a) In addition to the requirements of section 34(b) of the Basic Provisions, optional units may be established if each optional unit is:
(1) Located on non-contiguous land; or
(2) By varietal group.
3.
In addition to the requirements of section 3 of the Basic Provisions:
(a) You may select only one price election for all the apples in the county insured under this policy unless the Special Provisions provide different price elections by type, in which case you may select one price election for each apple type designated in the Special Provisions. The price elections you choose for each type must have the same percentage relationship to the maximum price offered by us for each type. For example, if you choose 100 percent of the maximum price election for one type, you must also choose 100 percent of the maximum price election for all other types.
(b) You must report, by the production reporting date designated in section 3 of the Basic Provisions, by type, if applicable:
(1) Any damage, removal of trees, change in practices, or any other circumstance that may reduce the expected yield below the yield upon which the insurance guarantee is based, and the number of affected acres;
(2) The number of bearing trees on insurable and uninsurable acreage;
(3) The age of the trees and the planting pattern; and
(4) For the first year of insurance for acreage interplanted with another perennial crop, and any time the planting pattern of such acreage has changed:
(i) The age and type of the interplanted crop, if applicable;
(ii) The planting pattern; and
(iii) Any other information that we request in order to establish your approved yield.
(c) We will reduce the yield used to establish your production guarantee as necessary, based on our estimate of the effect of the following: Interplanted perennial crop; removal of trees; damage; change in practices; and any other circumstance on the yield potential of the insured crop. If you fail to notify us of any circumstance that may reduce your yields from previous levels, we will reduce your production guarantee as necessary at any time we become aware of the circumstance.
4.
In accordance with section 4 of the Basic Provisions, the contract change date is October 31 preceding the cancellation date for California and August 31 preceding the cancellation date for all other states.
5.
(a) In accordance with section 2 of the Basic Provisions, the cancellation and termination dates are January 31 in California and November 20 in all other states.
(b) If your apple policy is canceled or terminated by us for any crop year, in accordance with the terms of the policy, after insurance attached for that crop year, but on or before the cancellation and termination dates whichever is later, insurance will be considered to have not attached for that crop year and no premium, administrative fee, or indemnity will be due for such crop year.
(c) We may not cancel your policy when an insured cause of loss has occurred after insurance attached, but prior to the cancellation date. However, your policy can be terminated if a cause for termination contained in sections 2 or 27 of the Basic Provisions exists.
6.
In addition to the requirements contained in section 6 of the Basic Provisions, you must report and designate all acreage by type by the acreage reporting date. Blocks of apple acreage grown for processing are not eligible for the Optional Coverage for Fresh Quality Adjustment option contained in section 14 of these Crop Provisions.
7.
In accordance with section 8 of the Basic Provisions, the crop insured will be all apples in the county for which a premium rate is provided by the actuarial table:
(a) In which you have a share;
(b) That are grown on tree varieties that are adapted to the area and have, in at least one of the previous four years, produced:
(1) 10 bins of apples per acre in Area A; or
(2) 150 bushels of apples per acre in Area B; or
(3) 200 bushels of apples per acre in Area C; and
(c) That are grown in an orchard that, if inspected, is considered acceptable by us.
8.
In lieu of the provisions in section 9 of the Basic Provisions that prohibit insurance from attaching to a crop planted with another crop, apples interplanted with another perennial crop are insurable unless we inspect the acreage and determine that it does not meet the requirements contained in your policy.
9.
(a) In accordance with the provisions of section 11 of the Basic Provisions:
(1) For the year of application in California, coverage begins on February 1 of the calendar year the insured crop normally blooms. In all other states, coverage begins November 21 of the calendar year prior to the calendar year the insured crop normally blooms, except that, if your application is received by us after January 12 but prior to February 1 in California, or after November 1 but prior to November 21 in all other states, insurance will attach on the 20th day after your properly completed application is received in our local office, unless we inspect the acreage during the 20-day period and determine that it does not meet insurability requirements. You must provide any information that we require for the crop or to determine the condition of the apple acreage.
(2) For each subsequent crop year that the policy remains continuously in force, coverage begins on the day immediately following the end of the insurance period for the prior crop year. Policy cancellation that results solely from transferring an existing policy to a different insurance provider for a subsequent crop year will not be considered a break in continuous coverage.
(3) The calendar date for the end of the insurance period for each crop year is November 5, or such other date as specified in the Special Provisions.
(4) Notwithstanding the provisions in this section, coverage will not be considered to have begun for a crop year if the policy is canceled or terminated in accordance with section 5(b).
(b) In addition to the provisions of section 11 of the Basic Provisions:
(1) If you acquire an insurable share in any insurable acreage after coverage begins but on or before the acreage reporting date for the crop year, and after an inspection we consider the acreage acceptable, insurance will be considered to have attached to such acreage on the calendar date for the beginning of the insurance period. There will be no coverage of any insurable interest acquired after the acreage reporting date.
(2) If you relinquish your insurable share on any insurable acreage of apples on or before the acreage reporting date for the crop year, insurance will not be considered to have attached to, and no premium or indemnity will be due for such acreage for that crop year unless:
(i) A transfer of coverage and right to an indemnity, or a similar form approved by us, is completed by all affected parties;
(ii) We are notified by you or the transferee in writing of such transfer on or before the acreage reporting date; and
(iii) The transferee is eligible for crop insurance.
(3) If you relinquish your insurable share on any insurable acreage of apples after the acreage reporting date for the crop year, insurance coverage will be provided for any loss due to an insurable cause of loss that occurred prior to the date that you relinquished your insurable share and the whole premium will be due for such acreage for that crop year.
10.
(a) In accordance with the provisions of section 12 of the Basic Provisions, insurance is provided only against the following causes of loss that occur during the insurance period and result in damaged apple production:
(1) Adverse weather conditions;
(2) Fire unless weeds and other forms of undergrowth have not been
(3) Insects, but not damage due to insufficient or improper application of pest control measures;
(4) Plant disease, but not damage due to insufficient or improper application of disease control measures;
(5) Earthquake;
(6) Volcanic eruption;
(7) Failure of irrigation water supply, if caused by an insured peril that occurs during the insurance period;
(8) Wildlife; and
(9) All other natural causes of loss that cannot be prevented, including, but not limited to, hail, wind, excess sun causing sunburn and frost and freeze causing russeting.
(b) In addition to the causes of loss excluded in section 12 of the Basic Provisions, we will not insure against damage or loss of production due to your inability to market the apples for any reason other than actual physical damage from an insurable cause specified in this section. For example, we will not pay you an indemnity if you are unable to market due to quarantine, boycott, or refusal of any person to accept production.
11.
In addition to the requirements of section 14 of the Basic Provisions, the following will apply:
(a) You must notify us at least 3 days prior to the date harvest should have started if the crop will not be harvested.
(b) You must notify us at least 15 days before any production from any unit will be sold by direct marketing. We will conduct an appraisal that will be used to determine your production to count for production that is sold by direct marketing. If damage occurs after this appraisal, we will conduct an additional appraisal. These appraisals, and any acceptable records provided by you, will be used to determine your production to count. Failure to give timely notice that production will be sold by direct marketing will result in an appraised amount of production to count of not less than the production guarantee per acre if such failure results in our inability to make the required appraisal.
(c) If you intend to claim an indemnity on any unit, you must notify us at least 15 days prior to the beginning of harvest, or immediately if damage is discovered during harvest. You must not sell or dispose of the damaged crop until after we have given you written consent to do so. If you fail to meet the requirements of this section and such failure results in our inability to inspect the damaged production, all such production will be considered undamaged and include it as production to count.
12.
(a) We will determine your loss on a unit basis. In the event, you are unable to provide separate acceptable production records:
(1) For any optional unit, we will combine all optional units for which such production records were not provided; or
(2) For any basic unit, we will allocate any commingled production to such units in proportion to our liability on the harvested acreage for the units.
(b) In the event of loss or damage covered by this policy, we will settle your claim on any unit by:
(1) Multiplying the insured acreage by its respective production guarantee, by type as applicable;
(2) Multiplying each result in section 12(b)(1) by the respective price election;
(3) Totaling the results in section 12(b)(2) if there are more than one type;
(4) Multiplying the total production to count (see section 12(c)), for each type as applicable, by the respective price election;
(5) Totaling the results in section 12(b)(4), if there are more than one type;
(6) Subtracting the total in section 12(b)(5) from the total in section 12(b)(3); and
(7) Multiplying the result in section 12(b)(6) by your share.
(c) The total production to count (in boxes or bushels) from all insurable acreage on the unit will include:
(1) All appraised production as follows:
(i) Not less than the production guarantee per acre for acreage:
(A) That is abandoned;
(B) That is sold by direct marketing if you fail to meet the requirements contained in section 11;
(C) That is damaged solely by uninsured causes; or
(D) For which you fail to provide production records that are acceptable to us;
(ii) Production lost due to uninsured causes;
(iii) Unharvested apple production that would be marketable if harvested; and
(iv) Potential marketable apple production on insured acreage that you intend to abandon or no longer care for, if you and we agree on the appraised amount of production. Upon such agreement, the insurance period for that acreage will end. If you do not agree with our appraisal, we may defer the claim only if you agree to continue to care for the crop. We will then make another appraisal when you notify us of further damage or that harvest is general in the area unless you harvested the crop, in which case we will use the harvested production. If you do not continue to care for the crop, our appraisal made prior to deferring the claim will be used to determine the production to count; and
(2) All harvested marketable production from the insurable acreage.
You have 100 percent share and designated 10 acres of fresh apples and 5 acres of processing apples in the unit on the acreage report, with a 600 bushels per acre guarantee for both fresh and processing apples and a price election of $9.10 per bushel for fresh apples and $4.76 per bushel for processing apples. You are only able to harvest 5,000 bushels of fresh apples and 1,000 bushels of processing apples that grade at least U.S. No. 1 Processing. Your indemnity would be calculated as follows:
A. 10 acres × 600 bushels = 6,000 bushels guarantee of fresh apples; 5 acres × 600 bushels = 3,000 bushels guarantee of processing apples;
B. 6,000 bushels × $9.10 price election = $54,600.00 value of guarantee for fresh apples; 3,000 bushels × $4.76 price election = $14,280.00 value of guarantee for processing apples;
C. $54,600.00 value of guarantee for fresh apples + $14,280.00 value of guarantee for processing apples = $68,880.00 total value guarantee;
D. 5,000 bushels of harvested marketable fresh apple production to count × $9.10 price election = $45,500.00 value of production to count for fresh apples; 1,000 bushels of harvested marketable processing apple production to count × $4.76 price election = $4,760.00 value of production to count for processing apples;
E. $45,500.00 value of production to count for fresh apples + $4,760.00 value of production to count for processing apples = $50,260.00 total value of production to count;
F. $68,880.00 total value guarantee −$50,260.00 total value of production to count = $18,620.00 value of loss; and
G. $18,620.00 value of loss × 100 percent share = $18,620.00 indemnity payment.
[End of Example]
(d) The production to count determined in accordance with section 12(c) will be used for APH purposes, regardless of whether there are any adjustments under section 14.
13.
The late and prevented planting provisions of the Basic Provisions are not applicable.
14.
(a) In the event of a conflict between the Apple Crop Insurance Provisions and this option, this option will control.
(b) In return for payment of the additional premium designated in the actuarial documents, this option provides for quality adjustment of fresh apple production as follows:
(1) To be eligible for this option, you must have elected to insure your apples at the additional coverage level. If you elect Catastrophic Risk Protection (CAT) after this option is effective, it will be considered as notice of cancellation of this option by you.
(2) You must elect this option on or before the sales closing date for the initial crop year for which you wish to insure your apples under this option. This option will continue in effect until canceled by either you or us for any succeeding crop year by written notice to the other party on or before the cancellation date.
(3) This option will apply to all your apple acreage designated in your acreage report as grown for fresh apples and that meets the insurability requirements specified in the Apple Crop Insurance Provisions, except any acreage specifically excluded by the actuarial documents. Any acreage designated in your acreage report as grown for processing apples is not eligible for coverage under this option.
(4) In lieu of sections 12(c)(1)(iii) and (iv) and (2), the production to count will include all appraised and harvested production for a unit's fresh apple acreage that grades at least U.S. No. 1 Processing, adjusted in accordance with this option.
(5) If appraised or harvested fresh apple production is damaged to the extent that 20 percent or more of the apples do not grade U.S. Fancy or better the following adjustments will apply:
(i) Fresh apple production to count with 21 percent through 40 percent damaged apple production will be reduced 2 percent for each full percent in excess of 20 percent.
(ii) Fresh apple production to count with 41 percent through 50 percent damaged apple production will be reduced 40 percent plus an additional 3 percent for each full percent in excess of 40 percent.
(iii) Fresh apple production to count with 51 percent through 64 percent damaged apple production will be reduced 70 percent plus an additional 2 percent for each full percent in excess of 50 percent.
(iv) Fresh apple production to count with 65 percent or more damaged apple production will not be considered production to count.
(v) Notwithstanding sections 14(b)(i) through (iv), if you sell any of your fresh apple production as U.S. Fancy, all such sold production will be included as production to count under this option. The following is an example of loss under the Optional Coverage for Fresh Fruit Quality Adjustment:
You have 100 percent share and designated 10 acres of fresh apples and 5 acres of processing apples in the unit on the acreage report, with a 600 bushel per acre guarantee for both fresh and processing apples and a price election of $9.10 per bushel for fresh apples and $4.76 per bushel for processing apples. You harvest 5,000 bushels of apples from your designated fresh acreage that grade U.S. No. 1 Processing or better, but only 2,650 of those bushels grade U.S. Fancy or better. You also harvest from your designated processing acreage 1,000 bushels apples that grade U.S. No. 1 Processing or better. Your indemnity would be calculated as follows:
A. 10 acres × 600 bushels per acre = 6,000 bushels guarantee of fresh apples; 5 acres × 600 bushels per acre = 3,000 bushels guarantee of processing apples;
B. 6,000 bushels guarantee of fresh apples × $9.10 price election = $54,600.00 value of guarantee for fresh apples; acreage; 3,000 bushels guarantee of processing apples × $4.76 price election = $14,280.00 value of guarantee for processing apple acreage;
C. $54,600.00 value of guarantee for fresh apple acreage + $14,280.00 value of guarantee for processing apple acreage = $68,880.00 total value of guarantee for all apple acreage;
D. The value of the fresh apple and processing apple production to count is determined as follows:
i. 5,000 bushels of apples that graded U.S. No. 1 or better − 2,650 bushels that graded U.S. Fancy = 2,350 bushels not grading U.S. Fancy;
ii. 2,350 / 5,000 = 47 percent of fresh apples that did not make U.S. Fancy grade;
iii. In accordance with section 14(b)(5)(ii): 47 percent − 40 percent = 7 percent in excess of 40 percent;
iv. 7 percent × 3 percent = 21 percent;
v. 40 percent + 21 percent = 61 percent;
vi. 5,000 bushels of apples that graded U.S. No. 1 or better × .61 (61 percent) = 3,050 bushels of fresh apple production to count;
vii. 3,050 bushels of fresh apples production to count × $9.10 = $27,755.00 value of the fresh apple production to count; 1,000 bushels of harvested marketable processing apple production to count × $4.76 price election = $4,760.00 value of the processing apple production to count;
E. $27,755.00 value of the fresh apple production to count + $4,760.00 value of the processing apple production to count = $32,515.00 total value of production to count;
F. $68,880.00 total value of guarantee for all apple acreage − $32,515.00 total value of production to count = $36,365.00 value of loss; and
G. $36,365.00 value of loss × 100 percent share = $36,365.00 indemnity payment.
[End of Example]
Rural Utilities Service, USDA.
Final rule.
The Rural Utilities Service (RUS), an agency delivering the United States Department of Agriculture's Rural Development Utilities Programs, is correcting its regulations relating to two RUS forms. RUS Form 211, Engineering Services Contract for the Design and Construction of a Generating Plant, and RUS Form 198, Equipment Contract, are being revised to correct two typographical errors and a numbering error, respectively.
Effective Date: September 27, 2004.
Mr. Fred J. Gatchell, Deputy Director, Electric Staff Division, Rural Utilities Service, U.S. Department of Agriculture, Stop 1569, 1400 Independence Ave., SW., Washington, DC 20250-1569. Telephone: (202) 720-1398. FAX: (202) 720-7491. E-mail:
RUS has determined that pursuant to 5 U.S.C. 553, a notice of proposed rule making and opportunity for comment is impracticable, unnecessary, or contrary to the public interest and is exempt from the provisions of Executive Order Nos. 12866 and 12988. It has been
On June 29, 1998, RUS revised 7 CFR 1724, Electric Engineering, Architectural Services and Design Policies and Procedures, which references RUS Form 211, Engineering Services Contract for the Design and Construction of a Generating Plant (63 FR 35312). A typographical error has been found in Article VI, Section 8 of this form. This rule updates the reference to the corrected form.
On February 13, 2004, RUS revised 7 CFR 1726, Electric System Construction Policies and Procedures, which references RUS Form 198, Equipment Contract (69 FR 7105). A typographical error has been found in Article II, Section 1 of this form. Also, a numbering error has been found in Article VI of this form. This rule updates the reference to the corrected form.
Electric power, Loan programs—energy, Reporting and recordkeeping requirements, Rural areas.
Electric power, Loan programs—energy, Reporting and recordkeeping requirements, Rural areas.
7 U.S.C. 901
(c) * * *
(1) RUS Form 211, Rev. 4-04, Engineering Service Contract for the Design and Construction of a Generating Plant. This form is used for engineering services for generating plant construction.
7 U.S.C. 901
(c) * * *
(4) RUS Form 198, Rev. 4-04, Equipment Contract. This form is used for equipment purchases.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action establishes Class E airspace at Shungnak, AK to provide adequate controlled airspace to contain aircraft executing two new Standard Instrument Approach Procedures (SIAP) and a new Textual Departure Procedure. This Rule results in new Class E airspace upward from 700 feet (ft.) and 1,200 feet above the surface at Shungnak, AK.
Effective 0901 UTC, November 25, 2004.
Jesse Patterson, AAL-538G, Federal Aviation Administration, 222 West 7th Avenue, Box 14, Anchorage, AK 99513-7587; telephone number (907) 271-5898; fax: (907) 271-2850; e-mail:
On Wednesday, June 9, 2004, the FAA proposed to revise part 71 of the Federal Aviation Regulations (14 CFR part 71) to create new Class E airspace upward from 700 ft. and 1,200 ft. above the surface at Shungnak, AK (69 FR 32289). The action was proposed in order to add Class E airspace sufficient in size to contain aircraft while executing two new Standard Instrument Approach Procedures and a new Textual Departure Procedure for the Shungnak Airport. In addition to the Textual Departure Procedure, the new approaches are Area Navigation-Global Positioning System (RNAV GPS) Runway (RWY) 9, original and (2) RNAV (GPS) Runway 27, original. Interested parties were invited to participate in this rulemaking proceeding by submitting written comments on the proposal to the FAA. No public comments have been received, thus, the rule is adopted as proposed.
The area will be depicted on aeronautical charts for pilot reference. The coordinates for this airspace docket are based on North American Datum 83. The Class E airspace areas designated as 700/1200 foot transition areas are published in paragraph 6005 of FAA Order 7400.9L,
This revision to 14 CFR part 71 establishes Class E airspace at Shungnak, Alaska. This additional Class E airspace was created to accomodate aircraft executing two new SIAPs and a textual departure procedure and will be depicted on aeronautical charts for pilot reference. The intended effect of this rule is to provide adequate controlled airspace for IFR operations at Shungnak Airport, Shungnak, Alaska.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated
Airspace, Incorporation by reference, Navigation (air).
49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 700 feet above the surface within a 6.5-mile radius of the Shungnak Airport and that airspace extending upward from 1,200 feet above the surface within a 30-mile radius of 66°45′29″ N 156°30′39″ W and within a 30-mile radius of 66°49′54.50″N 156°24′52.38″W, excluding the Ambler, AK Class E airspace.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action revises Class E airspace at King Salmon, AK to provide adequate controlled airspace to contain aircraft executing three new Standard Instrument Approach Procedures (SIAP). This Rule results in new Class E airspace upward from 1,200 feet above the surface at King Salmon, AK.
Effective 0901 UTC, November 25, 2004.
Jesse Patterson, AAL-538G, Federal Aviation Administration, 222 West 7th Avenue, Box 14, Anchorage, AK 99513-7587; telephone number (907) 271-5898; fax: (907) 271-2850; e-mail:
On Wednesday, June 9, 2004, the FAA proposed to revise part 71 of the Federal Aviation Regulations (14 CFR part 71) to create new Class E airspace upward from 1,200 ft. above the surface at King Salmon, AK (69 FR 32290). The action was proposed in order to add Class E airspace sufficient in size to contain aircraft while executing three new Standard Instrument Approach Procedures for the King Salmon Airport. The new approaches are Area Navigation-Global Positioning System (RNAV GPS) Runway (RWY) 11, original, (2) RNAV (GPS) Y RWY 29, original and (3) RNAV (GPS) Z RWY 29 original. Interested parties were invited to participate in this rulemaking proceeding by submitting written comments on the proposal to the FAA. No public comments have been received, thus, the rule is adopted as proposed.
The area will be depicted on aeronautical charts for pilot reference. The coordinates for this airspace docket are based on North American Datum 83. The Class E airspace areas designated as 700/1200 foot transition areas are published in paragraph 6005 of FAA Order 7400.9L,
This revision to 14 CFR part 71 establishes Class E airspace at King Salmon, Alaska. This additional Class E airspace was created to accommodate aircraft executing three new SIAPs and will be depicted on aeronautical charts for pilot reference. The intended effect of this rule is to provide adequate controlled airspace for IFR operations at King Salmon Airport, King Salmon, Alaska.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Airspace, Incorporation by reference, Navigation (air).
49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 700 feet above the surface within a 6.7-mile radius of the King Salmon Airport and within 4 miles northeast and 8 miles southwest of the King Salmon VORTAC 312° radial extending from the VORTAC to 21 miles northwest of the VORTAC and within 14 miles of the VORTAC 259° radial clockwise to the 004° radial and that airspace within 3.3 miles either side of the 132° radial of the VORTAC extending from the VORTAC to 17 miles southeast of the VORTAC; and that airspace extending upward from 1,200 feet above the surface within a 43-mile radius of the King Salmon Airport excluding the Yukon-Kuskokwim Delta, AK Class E airspace.
Customs and Border Protection; Department of Homeland Security.
Final rule.
Customs and Border Protection (CBP) periodically reviews its regulations to ensure that they are current, correct and consistent. Through this review process, CBP noted several discrepancies. This document remedies these discrepancies.
Effective August 27, 2004.
Christopher W. Pappas, Regulations Branch, Office of Regulations and Rulings, 202-572-8769.
It is the policy of Customs and Border Protection (CBP) to periodically review its regulations to ensure that they are as accurate and up-to-date as possible so that the importing and general public are aware of CBP programs, requirements, and procedures regarding import-related activities. As part of this review policy, CBP has determined that certain changes are necessary affecting parts 4, 10, 12, 18, 19, 101, 102, 122, 123, 141, 162, 163, 171 and 181 of the CBP Regulations (19 CFR parts 4, 10, 12, 18, 19, 101, 102, 122, 123, 141, 162, 163, 171 and 181).
Section 4.13 of the CBP Regulations (19 CFR 4.13) is based on 19 U.S.C. 1707, which was repealed by Public Law 104-295 of October 11, 1996. Accordingly, this document removes and reserves § 4.13.
Section 10.33 of the CBP Regulations (19 CFR 10.33) is being amended to correct a reference to the Harmonized Tariff Schedule of the United States (HTSUS) subheading 9813.00.65. This subheading was abolished by Presidential Proclamation 6763, the Uruguay Round of Multilateral Trade Negotiations, and for Other Purposes, of December 23, 1994. The same proclamation added, in Subchapter XVII of Chapter 98, HTSUS, subheading “9817.00.98 Theatrical scenery, properties and apparel brought into the United States by proprietors or managers of theatrical, ballet, opera or similar productions or exhibitions arriving from abroad for temporary use by them in such productions or exhibitions.” Accordingly, this document amends the HTSUS subheading in § 10.33 to read subheading 9817.00.98.
The authority for § 12.6, CBP Regulations (19 CFR 12.6) is being corrected. The current authority citation for § 12.6 includes a citation to “19 U.S.C. 1303” which has been repealed. Accordingly, this document revises the authority citation for § 12.6 by removing that authority.
Section 12.38, CBP Regulations (19 CFR 12.38) contains an outdated reference to § 171.22(b). Section 171.22(b) was removed by a final rule published in the
References to the “Interstate Commerce Commission” (ICC) in the heading of § 18.9, CBP Regulations (19 CFR 18.9) and in § 18.9(a) are outdated. The ICC Termination Act of 1995 (Public Law 104-88, 109 Stat. 803), enacted December 29, 1995, and effective January 1, 1996, eliminated the ICC and transferred the functions referenced in § 18.9 to the Surface Transportation Board. Accordingly, this document corrects these references to read the “Surface Transportation Board.”
There is an incorrect reference in § 19.12 of the CBP Regulations (19 CFR 19.12). Section 19.12(d)(4)(ii) refers to an exception to the requirement that a warehouse proprietor “file [a] permit folder with Customs “ [in] paragraph (b)(4)(iv) of this section.” This exception is found in § 19.12(d)(4)(iv), “Exemption to submission requirement.” Accordingly, this document amends § 19.12(d)(4)(ii) to reflect the correct reference.
Section 101.3 of the CBP Regulations (19 CFR 101.3) contains a table listing ports of entry by state along with the limits of each port. The limits of several ports were changed in T.D. 35546, T.D. 37386, T.D. 37439, T.D. 22305 and T.D. 39882; however, these changes were not reflected in the CBP Regulations. Accordingly, this document adds references to these Treasury Decisions in the “Limits of port” column in § 101.3. In addition, this document corrects the spelling of the Aguadilla port.
Section 101.4(c) of the CBP Regulations (19 CFR 101.4(c)) contains a table listing customs stations along with the supervisory port of entry for each station. The supervisory port of entry for the customs station of Antelope Wells, New Mexico, is no longer Rio Grande City, Texas. The supervisory port of entry for Antelope Wells is now Columbus, New Mexico. Accordingly, this document amends § 101.4(c) to reflect the correct supervisory port of entry.
Section 122.27(b) of the CBP Regulations (19 CFR 122.27(b)) contains a reference to the regulations of the “Export Administration (15 CFR parts 368 through 399).” These regulations are currently found at 15 CFR parts 730-774 and are referred to as the Export Administration Regulations. Accordingly, this document amends § 122.27(b) to reflect this name change and new citation.
Similarly, § 122.62(b) and (c) contain two references to the “Office of Export Administration” and two references to the “Export Control Regulations (15 CFR part 370).” The Office of Export Administration ceased to exist in 1988 when it was reformed as the Bureau of Export Administration. The Department
Section 123.1 of the CBP Regulations (19 CFR 123.1) contains a citation to 8 CFR 235.13 as the section relating to the PORTPASS program, a section which no longer exists. The PORTPASS regulations are now at 8 CFR 235.7. This document amends § 123.1(a) accordingly.
Sections 141.4(b)(4) and (d) of the CBP Regulations (19 CFR 141.4(b)(4) and (d)) reference Subchapter V, Chapter 99 of the HTSUS, particularly subheadings 9905.86.05 and 9905.86.10, HTSUS. Subchapter V, Chapter 99, HTSUS, was temporary in nature and only covered goods falling within its provisions through the close of December 31, 1998. Accordingly, this document amends § 141.4(b)(4) by removing the reference to “Chapter 99, Subchapter V, U.S. Note 9, HTSUS” and revises § 141.4(d) by removing the references to subheadings 9905.86.05 and 9905.86.10, HTSUS.
The dollar amount in § 162.76(c) of the CBP Regulations (19 CFR 162.76(c)) is changed by this document from $500 to $1000. This change conforms to 19 U.S.C. 1584(b)(1) as amended by section 3118(1) of Public Law 99-570 of October 27, 1986, “The Anti-Drug Abuse Act of 1986.”
The List of Records Required for an Entry of Merchandise set forth in the Appendix to part 163 of the CBP Regulations (19 CFR part 163) is also corrected by this document. Section IV of the Appendix incorrectly attributes 19 CFR 133.21(b)(6) of the CBP Regulations as the authority for the entry records requirement “Consent from trademark or trade name holder to import otherwise restricted goods.” This document removes the incorrect citation and adds the correct citations: 19 CFR 133.21(e), 133.22(c)(3) and 133.23(c).
Sections 171.51(b)(7) and 171.52(a), CBP Regulations (19 CFR 171.51(b)(7) and 171.52(a)) concern expedited petitioning procedures for administrative forfeiture proceedings for property subject to forfeiture under 19 U.S.C. 1595a, 21 U.S.C. 881, and 49 U.S.C. 80303. Sections 171.51(b)(7) and 172.52(a), and the specific authority citation for subpart F, currently set forth references to 19 U.S.C. 1595a, 21 U.S.C. 881, and 49 U.S.C. 80303. Section 888 of title 21 of the U.S. Code (21 U.S.C. 888), the basis for the expedited procedures for conveyances seized under 21 U.S.C. 881 and 49 U.S.C. 80303, was repealed by section 2(c)(3) of the Civil Asset Forfeiture Reform Act of 2000, Public Law 106-185 of April 25, 2000 (CAFRA). Title 19, however, is explicitly exempt from the CAFRA (See section 2(i)(2)(A) of the CAFRA). Accordingly, this document removes the incorrect references.
Finally, the specific authority for subpart D of part 181, CBP Regulations (19 CFR part 181) was inadvertently omitted from part 181. Accordingly, this document adds the specific authority: 19 U.S.C. 1520(d).
Because these amendments merely conform with existing law or regulation, notice and public procedure are unnecessary. For the same reason, pursuant to 5 U.S.C. 553(d)(3), a delayed effective date is not required. Because no notice of proposed rulemaking is required, the provisions of the Regulatory Flexibility Act (5 U.S.C. 601
This document is limited to technical corrections of CBP Regulations. Accordingly, it is being signed under the authority of 19 CFR 0.1(b).
The principal author of this document was Christopher W. Pappas, Regulations Branch, Office of Regulations and Rulings, CBP. However, personnel from other offices participated in its development.
Cargo vessels, Customs duties and inspection, Freight, Imports, Inspection, Maritime carriers, Merchandise, Shipping, Vessels.
Art, Customs duties and inspection, Entry, Imports, Preference programs, Shipments.
Customs duties and inspection, Entry of merchandise, Imports, Reporting and recordkeeping requirements.
Customs duties and inspection, Imports.
Customs duties and inspection, Imports, Reporting and recordkeeping requirements, Warehouses.
Customs duties and inspection, Customs ports of entry, Imports, Reporting and recordkeeping requirements.
Administrative practice and procedure, Imports, Reporting and recordkeeping requirements.
Canada, Customs duties and inspection, Freight, Imports, International boundaries (Land border), International traffic, Vehicles.
Customs duties and inspection, Entry of merchandise, Release of merchandise.
Drug traffic control, Law enforcement, Prohibited merchandise.
Customs duties and inspection, Reporting and recordkeeping requirements.
Law enforcement, Penalties, Seizures and forfeitures.
Customs duties and inspection, Imports, Reporting and recordkeeping.
5 U.S.C. 301; 19 U.S.C. 66, 1431, 1433, 1434, 1624; 46 U.S.C. App. 3, 91.
19 U.S.C. 66, 1202 (General Note 23, Harmonized Tariff Schedule of the United States (HTSUS)), 1321, 1481, 1484, 1498, 1508, 1623, 1624, 3314;
5 U.S.C. 301; 19 U.S.C. 66, 1202 (General Note 23, Harmonized Tariff Schedule of the United States (HTSUS)), 1624;
Section 12.6 also issued under 7 U.S.C. 1854;
5 U.S.C. 301; 19 U.S.C. 66, 1202 (General Note 23, Harmonized Tariff Schedule of the United States), 1551, 1552, 1553, 1623, 1624.
(a) Upon presentation of proper credentials showing the applicant to be a representative of the Trunk Line Association, the Surface Transportation Board, the Joint Rate Inspection Bureau of Chicago or the Southern Weighing and Inspection Bureau of Atlanta, inspectors of CBP in charge will permit such applicant to examine packages containing in-bond merchandise described in the manifest in general terms for the purpose of ascertaining whether the merchandise is properly classified under the interstate commerce laws.
5 U.S.C. 301; 19 U.S.C. 66, 1202 (General Note 23, Harmonized Tariff Schedule of the United States), 1624;
5 U.S.C. 301; 19 U.S.C. 2, 66, 1202 (General Note 23, Harmonized Tariff Schedule of the United States), 1623, 1624, 1646a.
Sections 101.3 and 101.4 also issued under 19 U.S.C. 1 and 58b;
5 U.S.C. 301; 19 U.S.C. 58b, 66, 1431, 1433, 1436, 1448, 1459, 1590, 1594, 1623, 1624, 1644, 1644a.
19 U.S.C. 66, 1202 (General Note 23, Harmonized Tariff Schedule of the United States (HTSUS)), 1431, 1433, 1436, 1448, 1624.
Section 123.1 also issued under 19 U.S.C. 1459;
19 U.S.C. 66, 1448, 1484, 1624.
Section 141.4 also issued under 19 U.S.C. 1202 (General Note 19; Chapter 86, Additional U.S. Note 1; Chapter 89, Additional U.S. Note 1; Chapter 98, Subchapter III, U.S. Notes 3 and 4; Harmonized Tariff Schedule of the United States), 1498;
(d)
5 U.S.C. 301; 19 U.S.C. 66, 1592, 1593a, 1624.
5 U.S.C. 301; 19 U.S.C. 66, 1484, 1508, 1509, 1510, 1624.
18 U.S.C. 983; 19 U.S.C. 66, 1592, 1593a, 1618, 1624; 22 U.S.C. 401; 31 U.S.C. 5321; 46 U.S.C. App. 320.
Subpart F also issued under 19 U.S.C. 1595a, 1605, 1614.
19 U.S.C. 66, 1202 (General Note 23, Harmonized Tariff Schedule of the United States), 1624, 3314.
Subpart D of part 181 also issued under 19 U.S.C. 1520(d).
Food and Drug Administration, HHS.
Final rule; technical amendment; correction.
The Food and Drug Administration (FDA) is correcting a document that amended its regulations to reflect name and address changes for the Office of Compliance, Center for Drug Evaluation and Research (CDER). The document was published in the
This rule is effective August 11, 2004
.Joyce A Strong, Office of Policy (HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7010.
FDA is correcting a document that amended its regulations in 21 CFR part 5 to correct certain mail codes in the Office of Compliance, CDER.
Authority delegations (Government agencies), Imports, Organization and functions (Government agencies).
5 U.S.C. 552; 21 U.S.C. 301-397.
Coast Guard, DHS.
Final rule.
The Coast Guard is establishing regulations for the security of Department of Defense assets and military cargo in Puget Sound, Washington. This rule, when enforced by the Captain of the Port Puget Sound, would provide for the regulation of vessel traffic in the vicinity of military cargo loading facilities in the navigable waters of the United States.
This rule is effective August 27, 2004.
Comments and material received from the public, as well as documents indicated in this preamble as being available in the docket, are part of docket CGD13-04-019 and are available for inspection or copying at Commanding Officer, Marine Safety Office Puget Sound, 1519 Alaskan Way South, Seattle, Washington 98134 between 8 a.m. and 4 p.m., Monday through Friday, except Federal holidays.
LTjg T. Thayer, c/o Captain of the Port Puget Sound, 1519 Alaskan Way South, Seattle, WA 98134, (206) 217-6232. For specific information concerning enforcement of this rule, call Marine Safety Office Puget Sound at (206) 217-6200 or (800) 688-6664.
On May 14, 2004, we published a notice of proposed rulemaking (NPRM) entitled “Security Zones; Protection of Military Cargo, Captain of the Port Zone Puget Sound, WA” in the
The Coast Guard finds good cause exists to make this rule effective less than 30 days after publication. This rule establishes security zones during military cargo loading and unloading operations. The Captain of the Port Puget Sound deems it necessary to make this rule effective upon publication in the
Hostile entities continue to operate with the intent to harm U.S. National Security by attacking or sabotaging national security assets. The President has continued the national emergencies he declared following the September 11, 2001 terrorist attacks. ((67 FR 58317, Sept. 13, 2002) (continuing national emergency with respect to terrorist attacks); (67 FR 59447, Sept. 20, 2002) (continuing national emergency with respect to persons who commit, threaten to commit or support terrorism); (68 FR 55189, Sept. 22, 2003) (continuing national emergency with respect to persons who commit, threaten to commit or support terrorism)).
The President also has found pursuant to law, including the Magnuson Act (50 U.S.C. 191
The ongoing hostilities in Afghanistan and Iraq have made it prudent for U.S. ports and waterways to be on a higher state of alert because the Al Qaeda organization and other similar organizations have declared an ongoing intention to conduct armed attacks on U.S. interests worldwide. The Coast Guard, through this rule, intends to assist the Department of Defense to protect vital national security assets, in waters of Puget Sound. This rule establishes security zones and notification requirements that will exclude persons and vessels from these zones during military cargo loading and unloading operations. Entry into these zones will be prohibited unless authorized by the Captain of the Port or his designee. The Captain of the Port may be assisted by other federal, state, or local agencies.
Since January 29 of this year, the Captain of the Port has issued four temporary final rules establishing security zones in Commencement Bay, Washington. These temporary final rules have been established to protect facilities used by vessels to load and/or unload military cargo. Moreover, these temporary zones have differed in size and description. This rule would establish a permanent, uniform, security zone, which would control vessel movement in and around the Blair and Sitcum Waterways, Commencement Bay, WA. However, the Captain of the Port will only enforce this rule after issuing a notice of enforcement. Upon notice of suspension of enforcement, all persons and vessels are authorized to enter, move within and exit these security zones. This rule is deemed necessary to protect vital national security assets and military cargo.
No comments were received by the Coast Guard as a result of the request for comments in our NPRM. However, we did receive several telephone calls regarding the latitude and longitude positions of the proposed zone. These callers identified two points (the point for the approximate location of the private buoy and the northwestern corner of Pier No. 5) that had been transposed in paragraphs (c)(1) and (c)(2) of our proposed rule. These points have been corrected to accurately reflect the location of these two security zones.
This rule is not a significant regulatory action under section 3(f) of Executive Order 12866 and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS). We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is unnecessary. Although this rule would restrict access to the regulated area, the effect of this rule would not be significant. This expectation is based on the fact that the regulated area established by the rule would encompass a limited area in the Blair and Sitcum Waterways, Commencement Bay, WA. In addition, temporary final rules established for past cargo loading and unloading operations have only lasted from a few days to over a week in duration. Hence, the Coast Guard expects that enforcement of this rule will be of similar duration. Further, Coast Guard forces will actively monitor and enforce the Blair Waterway and Sitcum Waterway security zones and are authorized by the Captain of the Port to grant authorization to vessels to enter these waterways. In addition, in certain circumstances VTS may grant authorization to enter, move within or depart these waterways. In other words,
Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.
The Coast Guard certifies under 5 U.S.C. 605(b) that this rule would not have a significant economic impact on a substantial number of small entities.
This rule would affect the following entities, some of which may be small entities: the owners or operators of vessels intending to operate near or anchor in the vicinity of Blair and/or Sitcum Waterways.
This rule would not have a significant economic impact on a substantial number of small entities for the following reasons: (i) Individual security zones are limited in size; (ii) designated representatives of the Captain of the Port may authorize access to the security zone; (iii) security zones for any given operation will affect a given geographical location for a limited time; (iv) the Coast Guard will make notifications via maritime advisories so mariners can adjust their plans accordingly and (v) the Coast Guard will cause a notice of suspension of enforcement to be published when cargo loading or unloading operations have concluded.
If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule so that they can better evaluate its effects on them and participate in the rulemaking. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact one of the points of contact listed under
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).
This rule would call for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
This rule would not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and would not create an environmental risk to health or risk to safety that might disproportionately affect children.
The Coast Guard recognizes the rights of Native American Tribes under the Stevens Treaties. Moreover, the Coast Guard is committed to working with Tribal Governments to implement local policies to mitigate tribal concerns. We have determined that these security zones and fishing rights protection need not be incompatible. We have also determined that this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Nevertheless, Indian Tribes that have questions concerning the provisions of this rule or options for compliance are encourage to contact the point of contact listed under
We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.
The Coast Guard's preliminary review indicates this rule is categorically excluded from further environmental documentation under figure 2-1, paragraph 34(g) of Commandant Instruction M16475.1D. The environmental analysis and Categorical Exclusion Determination will be
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 50 U.S.C. 191, 195; 33 CFR 1.05-1(g), 6.04-1, 6.04-6, and 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(1)
(2)
(d)
(e)
(f)
(g)
(h)
(i)
United States Patent and Trademark Office, Commerce.
Final rule.
The United States Patent and Trademark Office (referred to as “we”, “us”, or “our” in this notice) is adjusting certain patent fee amounts to reflect fluctuations in the Consumer Price Index (CPI). Also, we are adjusting, by a corresponding amount, a few patent fees that track the affected fees. The Director is authorized to adjust these fees annually by the CPI to recover the higher costs associated with doing business.
Effective October 1, 2004.
Tamara McClure by e-mail at
This final rule adjusts our fees in accordance with the applicable provisions of title 35, United States Code, as amended by the Consolidated Appropriations Act, Fiscal Year 2000 (which incorporated the Intellectual Property and Communications Omnibus Reform Act of 1999) (Pub. L. 106-113). This final rule also adjusts, by a corresponding amount, a few patent fees(37 CFR 1.17(e), (r), (s), and (t)) that track statutory fees (either 37 CFR 1.16(a) or 1.17(m)).
A proposed rule notice was published at 69 FR 25861 on May 10, 2004, which requested comments by June 9, 2004. No comments were received.
Legislation has been proposed and passed by the House of Representatives that would alter our fee amounts and procedures. The United States Patent and Trademark Fee Modernization Act of 2004 (H.R. 1561) passed the House of Representatives on March 3, 2004. Similar legislation is pending in the Senate as S. 1760. Customers should be aware that legislative changes to our fees would supersede certain patent fees in this final rule. If such legislative changes occur, we will need to make corresponding changes to the rules of practice to conform them to the fees as set forth in such legislation. Customers may wish to refer to our official Web site at
In addition, certain rules on fees associated with practices of the Board of Patent Appeals and Interferences are being consolidated in a new part 41 of 37 CFR. These changes were made in accordance with applicable provisions set forth in the final rule notice
Patent fees are authorized by 35 U.S.C. 41, 119, 120, 132(b) and 376. For fees paid under 35 U.S.C. 41(a) and (b) and 132(b), independent inventors, small business concerns, and nonprofit organizations who meet the requirements of 35 U.S.C. 41(h)(1) are entitled to a fifty-percent reduction.
Section 41(f) of title 35, United States Code, provides that fees established under 35 U.S.C. 41(a) and (b) may be adjusted on October 1, 1992, and every year thereafter, to reflect fluctuations in the CPI over the previous twelve months.
Section 41(d) of title 35, United States Code, authorizes the Director to establish fees for all other processing, services, or materials related to patents to recover the average cost of providing these services or materials, except for the fees for recording a document affecting title, for each photocopy, for each black and white copy of a patent, and for standard library service.
Section 41(g) of title 35, United States Code, provides that new fee amounts established by the Director under section 41 may take effect thirty days after notice in the
The patent statutory fees established by 35 U.S.C. 41(a) and (b) will be adjusted on October 1, 2004, to reflect fluctuations occurring during the twelve-month period from October 1, 2003, through September 30, 2004, in the Consumer Price Index for All Urban Consumers (CPI-U). The Office of Management and Budget has advised us that in calculating these fluctuations, we should use CPI-U data as determined by the Secretary of Labor. In accordance with previous fee-setting methodology, we base this fee adjustment on the Administration's projected CPI-U for the twelve-month period ending September 30, 2004, which is 3.01 percent. Based on this projected CPI-U, patent statutory fees will be adjusted by 3.01 percent.
Certain patent processing fees established under 35 U.S.C. 41(d), 119, 120, 132(b), 376, and Pub. L. 103-465 (the Uruguay Round Agreements Act) will be adjusted to reflect fluctuations in the CPI.
The fee amounts were rounded by applying standard arithmetic rules so that the amounts rounded will be convenient to the user. Fees for other than a small entity of $100 or more were rounded to the nearest $10. Fees of less than $100 were rounded to an even number so that any comparable small entity fee will be a whole number.
Any fee amount that is paid on or after the effective date of the fee adjustment will be subject to the new fees then in effect. The amount of the fee to be paid will be determined by the time of filing. The time of filing will be determined either according to the date of receipt in our office or the date reflected on a proper Certificate of Mailing or Transmission, where such a certificate is authorized under 37 CFR 1.8. Use of a Certificate of Mailing or Transmission is not authorized for items that are specifically excluded from the provisions of § 1.8. Items for which a Certificate of Mailing or Transmission under § 1.8 are not authorized include, for example, filing of Continued Prosecution Applications (CPAs) under § 1.53(d) and other national and international applications for patents.
Patent-related correspondence delivered by the “Express Mail Post Office to Addressee” service of the United States Postal Service (USPS) is considered filed or received in our office on the date of deposit with the USPS.
To ensure clarity in the implementation of the new fees, a discussion of specific sections is set forth below.
Section 1.16, paragraphs (a), (b), (d), and (f) through (i), are revised to adjust fees established therein to reflect fluctuations in the CPI.
Section 1.17, paragraphs (a)(2) through (a)(5), (e), (m), and (r) through (t), are revised to adjust fees established therein to reflect fluctuations in the CPI.
Section 1.18, paragraphs (a) through (c), are revised to adjust fees established therein to reflect fluctuations in the CPI.
Section 1.20, paragraphs (e) through (g), are revised to adjust fees established therein to reflect fluctuations in the CPI.
Section 1.492, paragraphs (a)(1) through (a)(3), (a)(5), (b) and (d), are revised to adjust fees established therein to reflect fluctuations in the CPI.
Section 41.20, paragraphs (b)(1) through (b)(3), are revised to adjust fees established therein to reflect fluctuations in the CPI.
This final rule contains no information collection requirements within the meaning of the Paperwork Reduction Act of 1995, 44 U.S.C. 3501
The Deputy General Counsel for General Law of the United States Patent and Trademark Office has certified to the Chief Counsel for Advocacy, Small Business Administration, that the final rule change will not have a significant economic impact on a substantial number of small entities (Regulatory Flexibility Act, 5 U.S.C. 605(b)). The final rule change increases fees to reflect the change in the CPI as authorized by 35 U.S.C. 41(f). Further, the principal impact of the major patent fees has already been taken into account in 35 U.S.C. 41(h)(1), which provides small entities with a fifty-percent reduction in the major patent fees.
By statute, the USPTO's Director is expressly authorized to adjust fees annually to reflect fluctuations in the CPI.
The final rule increases fees to reflect the change in the CPI as authorized by 35 U.S.C. 41(f). The fee increases would range from a minimum of $2 to a maximum of $100 under the final rule.
Under 35 U.S.C. 41(h)(1) small entities are accorded a fifty-percent reduction in most patent fees. Consequently, the small entity fee increases range from a minimum of $1 to a maximum of $50 under the final rule. The sole exception under this final rule is the fee set forth under 37 CFR 1.17(t), which does not qualify for a small entity fee reduction. The fee increase for 37 CFR 1.17(t) is $40.
Accordingly, the final rule does not have a significant economic impact on a substantial number of small entities.
Administrative practice and procedure, Biologies, Courts, Freedom of Information, Invention and patents, Reporting and recordkeeping requirements, Small businesses.
Administrative practice and procedure, Inventions and patents, Lawyers.
35 U.S.C. 2, unless otherwise noted.
(a) Basic fee for filing each application for an original patent, except provisional, design, or plant applications:
(b) In addition to the basic filing fee in an original application, except provisional applications, for filing or later presentation of each independent claim in excess of 3:
(d) In addition to the basic filing fee in an original application, except provisional applications, if the application contains, or is amended to contain, a multiple dependent claim(s), per application:
(f) Basic fee for filing each design application:
(g) Basic fee for filing each plant application, except provisional applications:
(h) Basic fee for filing each reissue application:
(i) In addition to the basic filing fee in a reissue application, for filing or later presentation of each independent claim which is in excess of the number of independent claims in the original patent:
(a) * * *
(2) For reply within second month:
(3) For reply within third month:
(4) For reply within fourth month:
(5) For reply within fifth month:
(e) To request continued examination pursuant to § 1.114:
(m) For filing a petition for the revival of an unintentionally abandoned application, for the unintentionally delayed payment of the fee for issuing a patent, or for the revival of an unintentionally terminated reexamination proceeding under 35 U.S.C. 41(a)(7) (§ 1.137(b)):
(r) For entry of a submission after final rejection under § 1.129(a):
(s) For each additional invention requested to be examined under § 1.129(b):
(t) For the acceptance of an unintentionally delayed claim for priority under 35 U.S.C. 119, 120, 121, or 365(a) or (c):
(a) Issue fee for issuing each original or reissue patent, except a design or plant patent:
(b) Issue fee for issuing a design patent:
(c) Issue fee for issuing a plant patent:
(e) For maintaining an original or reissue patent, except a design or plant patent, based on an application filed on or after December 12, 1980, in force beyond four years; the fee is due by three years and six months after the original grant:
(f) For maintaining an original or reissue patent, except a design or plant patent, based on an application filed on or after December 12, 1980, in force beyond eight years; the fee is due by seven years and six months after the original grant:
(g) For maintaining an original or reissue patent, except a design or plant patent, based on an application filed on or after December 12, 1980, in force beyond twelve years; the fee is due by eleven years and six months after the original grant:
(a) * * *
(1) Where an international preliminary examination fee as set forth in § 1.482 has been paid on the international application to the United States Patent and Trademark Office:
(2) Where no international preliminary examination fee as set forth in § 1.482 has been paid to the United States Patent and Trademark Office, but an international search fee as set forth in § 1.445(a)(2) has been paid on the international application to the United States Patent and Trademark Office as an International Searching Authority:
(3) Where no international preliminary examination fee as set forth in § 1.482 has been paid and no international search fee as set forth in § 1.445(a)(2) has been paid on the international application to the United States Patent and Trademark Office:
(5) Where a search report on the international application has been prepared by the European Patent Office or the Japan Patent Office:
(b) In addition to the basic national fee, for filing or later presentation of each independent claim in excess of 3:
(d) In addition to the basic national fee, if the application contains, or is amended to contain, a multiple dependent claim(s), per application:
35 U.S.C. 2(b)(2), 3(a)(2)(A), 21, 23, 32, 41, 134, 135, unless otherwise noted.
(b)
(1) For filing a notice of appeal from the examiner to the Board:
(2) In addition to the fee for filing a notice of appeal, for filing a brief in support of an appeal:
(3) For filing a request for an oral hearing before the Board in an appeal under 35 U.S.C. 134:
Postal Service.
Final rule.
This rule amends the Postal Service's regulations concerning tort claims to correct mailing addresses and to clarify ambiguous provisions.
Effective August 27, 2004.
Frank M. Bartholf, Managing Counsel, General Law Service Center, P.O. Box 66640, St. Louis, MO 63166-6640; telephone (314) 872-5120.
Amendment of part 912 is necessary to reflect organizational changes that have occurred in the Postal Service since the
Administrative practice and procedure; Claims.
28 U.S.C. 2671-2680; 28 CFR 14.1 through 14.11; 39 U.S.C. 409.
Claims should be filed with the Tort Claims Coordinator for the Postal Service District Office where the accident occurred, but may be filed at any office of the Postal Service, or sent directly to the Chief Counsel, National Tort Center, U.S. Postal Service, P.O. Box 66640, St. Louis, MO 63166-6640.
(a) * * * A standard Form 95 may be obtained from the local District Tort Claims Coordinator, the National Tort Center, or online at usa.gov (select Government forms).
(b) A claim presented in compliance with paragraph (a) of this section may be amended by the claimant at any time prior to:
(1) The claimant's exercise of the option to file a civil action pursuant to 28 U.S.C. 2675(a);
(2) The Postal Service's issuance of a payment in the full amount of the claim; or
(3) The Postal Service's issuance of a written denial of the claim in accordance with § 912.9.
Assistant Secretary—Policy, Management and Budget, Interior.
Interim final rule with request for comments.
The Department of the Interior is including an option to allow service contractors to remove woody biomass generated as a result of land management service contracts wherever ecologically appropriate and in accordance with the law. A new provision added to the Department's acquisition regulations specifies a contract clause to be used for this purpose. This rule does not make any other changes.
This rule is efffective August 27, 2004. We must receive all comments on this rule by October 26, 2004.
You may submit comments, identified by the number 1084-AA00 by any of the following methods:
Wiley Horsley, Office of Acquisition and Property Management, Department of the Interior at (202) 208-3347, or e-mail at
This action establishes consistent and efficient procedures to allow contractors the option to remove woody biomass by-products from Department of the Interior land management activities. This option, where ecologically appropriate, will provide economic and social benefits by creating jobs and conserving natural resources. Removal or use of woody biomass will reduce smoke and emissions from prescribed and natural fires; preserve landfill capacities; reduce the threat of catastrophic wildfires to communities and public/private utilities; improve watershed and wildlife habitat protection; and improve forest, woodland, and rangeland health. The Forest Service, U.S. Department of Agriculture, has in place provisions in timber sale, service and stewardship contracts that provide opportunities to utilize the type of materials included in this rule.
Because this revision to existing regulations is necessary to enable immediate use of forest product biomass for beneficial purposes, we are publishing this revision as an interim final rule. In accordance with the “good cause” exemption found at the 5 U.S.C. 553(b)(B), we have determined that publishing a proposed rule would be impracticable because the extra time necessary to publish a proposed rule would delay the many benefits accruing from biomass utilization. Moreover, this rule provides a benefit rather than imposing a burden or penalty of any kind upon applicable persons. Immediate implementation of this rule is necessary to treat hazardous fuels and forest health by-products in a timely and cost-efficient manner and thereby reduce the threat of catastrophic wildfire and forest health threats, such as, insects, disease, and invasive plant and animal species. For the same reasons, pursuant to 5 U.S.C. 553(d), it is determined that there is good cause for this interim final rule to become effective immediately upon publication.
All comments received on or before the comment closing date will be considered before taking final action on this rulemaking. The provisions of this interim rule may be changed in light of comments received.
This document is not a significant rule and the Office of Management and Budget has not reviewed this rule under Executive Order 12866.
(1) This rule will not have an effect of $100 million or more on the economy. It will not adversely affect in a material way the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities. The contractors and the general public are not required to perform services or process materials; woody products will be removed and compensated, if appropriate, at fair market value as agreed upon.
(2) This rule will not create a serious inconsistency or otherwise interfere with an action taken or planned by another agency. This policy only applies to Department of the Interior Bureaus; other agencies and governments could positively benefit from the development of small-wood markets and any tax or economic rewards.
(3) This rule does not alter the budgetary effects of entitlements, grants, user fees, or loan programs or the rights or obligations of their recipients. The contractor will be provided a new option, if executed, which is exclusive of other rights and benefits.
(4) This rule does not raise novel legal or policy issues. This policy uses existing authorities within existing policies.
The Department of the Interior certifies that this document will not have a significant economic effect on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule:
a. Does not have an annual effect on the economy of $100 million or more. The woody by-products have limited economic value (small diameter, low value trees and woody material), are unused or underutilized in current market conditions, and/or are by nature, incidental by-products.
b. Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions. The quantities are small in size and amount, are widely scattered across the nation, and are low-value products.
c. Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises. The policy would increase U.S-based economic opportunities, employment, innovation, and conservation of energy and resources.
This rule does not impose an unfunded mandate on State, local, or tribal governments or the private sector of more than $100 million per year. The rule does not have a significant or unique effect on State, local, or tribal governments or the private sector. A statement containing the information required by the Unfunded Mandates Reform Act (2 U.S.C. 1531
In accordance with Executive Order 12630, the rule does not have significant takings implications. No rights, property or compensation has been, or will be taken. A takings implication assessment is not required.
In accordance with Executive Order 13132, the rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. The rule grants optional rights and increased economic opportunities to individuals, States, local governments, and Tribes, in furtherance of Section 2(h) of E.O. 13132. A Federalism Assessment is not required.
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.
In accordance with Executive Order 13175, we have evaluated this rule and determined that it has no potential negative effects on federally recognized Indian tribes. We will fully consider tribal views in the final rule. We have consulted with the appropriate bureaus and offices of the Department about the potential effects of this rule on Indian tribes, including the Bureau of Indian Affairs.
This regulation does not require an information collection from 10 or more parties and a submission under the Paperwork Reduction Act is not required. An OMB form 83-I is not required.
This rule does not constitute a major Federal action significantly affecting the quality of the human environment. Federal agencies should consider the environmental effects of woody biomass utilization in each project where woody biomass utilization is appropriate and make a determination of significance for that project.
If you wish to comment on this interim rule, you may submit your comments by any one of several methods.
(1) You may mail comments to Office of Wildland Fire Coordination, Department of the Interior, MS-3060 1849 C Street NW., Washington, DC 20240.
(2) You may submit comments electronically by visiting the
(3) You may comment via the Internet to
(4) You may hand-deliver comments to Office of Wildland Fire Coordination, MS-3060, Department of the Interior, 1849 C Street NW., Washington, DC 20240.
Our practice is to make comments, including names and home addresses of respondents, available for public review during regular business hours. Individual respondents may request that we withhold their home address from
There may be circumstances in which we would withhold from the rulemaking record a respondent's identity, as allowable by law. If you wish us to withhold your name and/or address, you must state this prominently at the beginning of your comment. However, we will not consider anonymous comments. We will make all submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, available for public inspection in their entirety.
Forests and forest products, Government procurement.
30 U.S.C. 601-604, 611, as amended; 16 U.S.C. 668dd; 16 U.S.C. 1; 25 U.S.C. 3101
This part establishes consistent and efficient procedures to allow contractors the option to remove woody biomass by-products from Department of the Interior land management activities where ecologically appropriate. If the woody biomass has fair market value and payment is required, or as required by regulation, Bureau policy or the Mineral Materials Disposal Act of 1947 (30 U.S.C. 601
(a) The Department of the Interior allows and encourages contractors to remove and use woody biomass from project areas when:
(1) The biomass is generated during land management service contract activity; and
(2) Removal is ecologically appropriate.
(b) A contractor removing biomass under this part shall:
(1) Do so only within legal limits applicable to the contractor, including National Environmental Policy Act (NEPA) compliance; and
(2) If required, comply with the terms, conditions and special provisions of the applicable timber/vegetative sales notice.
This section applies to any solicitation or contract that is expected to generate woody biomass that meets the requirements of § 1437.101 unless biomass removal is already required in the service contract. The agency contracting officer will:
(a) Insert in the solicitation or contract the clause in § 1437.103;
(b) Specify any limitations on types of woody biomass that may not be removed; and
(c) Specify any areas from which woody biomass must not be removed.
The contracting officer must insert a clause reading substantially as follows in each solicitation and contract that meets the criteria in § 1437.101(a):
1. The contractor may remove and utilize woody biomass, if:
(a) Project work is progressing as scheduled; and
(b) Removal is completed before contract expiration.
2. To execute this option, the contractor must submit a written request to the Government.
3. Following receipt of the written request, and if appropriate, the Government and the contractor will negotiate and execute a separate timber/vegetative sales contract. Payment under this sales contract must be at a price equal to or greater than the appraised value before the removal of any woody biomass. The contractor must make any appropriate payment specified in this timber/vegetative sales contract.
4. If required by law, regulation or Bureau policy, the Government will prepare a timber/vegetative sales notice and/or prospectus, including volume estimates, appraised value and any appropriate special provisions.
5. The contractor must treat any woody biomass not removed in accordance with the specifications in the service contract.
6. The sales contract and service contract are severable; default or termination under either contract does not remove the contractor from payment or performance obligations under the other contract.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Final rule.
NMFS issues a final rule to allow processors to use the offal from
Effective on September 27, 2004.
Copies of the Categorical Exclusion and Regulatory Impact Review (RIR) prepared for this action, and the Environmental Assessments prepared for Amendments 26/29 and Amendments 50/50 to the Alaska groundfish fishery management plans, may be obtained from NMFS, Alaska Region, P.O. Box 21668, Juneau, AK 99802, Attn: Lori Durall.
Jason Anderson, 907-586-7228, or
NMFS manages the groundfish fishery in the Exclusive Economic Zone of the Bering Sea and Aleutian Islands management area (BSAI) and the Gulf of Alaska (GOA) under the Fishery Management Plan for Groundfish Fishery of the Bering Sea and Aleutian Islands Area and the Fishery Management Plan for the Groundfish of the Gulf of Alaska (FMPs). The North Pacific Fishery Management Council (Council) prepared, and NMFS approved, the FMPs under the authority of the Magnuson-Stevens Act (16 U.S.C. 1801
Prohibited species are defined at 50 CFR 679.2 to include all species of Pacific salmon, steelhead trout, Pacific halibut, Pacific herring, king crab and Tanner crab caught by a vessel regulated under part 679 while fishing for groundfish in the BSAI or GOA.
All prohibited species catch (PSC) is to be avoided, but if caught while fishing for groundfish, prohibited species must be returned to the sea with a minimum of injury, under regulations at 50 CFR 679.21.
Some groundfish fishing vessels are incapable of sorting their catch at sea, and deliver their entire catch to an onshore processor or a processor vessel. Sorting and discarding of prohibited species occurs at delivery. To reduce the amount of edible protein discarded in that process, the Council initially recommended the PSD program for salmon, which was implemented by NMFS in 1996. The program was expanded to include halibut in 1997. Regulations implementing the PSD program are found at 50 CFR 679.26.
The PSD program allows PSC salmon and halibut to be processed and distributed through tax-exempt hunger relief organizations. The implementing regulations prohibit authorized distributors and persons conducting activities supervised by authorized distributers from consuming or retaining prohibited species for personal use. They may not sell, trade or barter any prohibited species that are retained under the PSD program.
In 2001, processors stopped retaining salmon under the PSD program because current regulations prohibit them from processing and selling the waste parts of salmon (e.g., heads, guts, bones, skin) that are not distributed under the PSD program. Processors found it impractical to separate this offal from the leftover parts of commercial groundfish, which they render into meal and oil, products that may be marketed.
To stop the processing of PSC salmon and halibut for this reason, however, would defeat the PSD program's purpose of donating fish for hunger relief that otherwise would be discarded. Therefore, NMFS Enforcement issued an advisory bulletin on April 4, 2002 (Information Bulletin 02-30), stating that NMFS would not enforce regulations that prohibit converting halibut or salmon offal into meal under the PSD program. According to the bulletin, “NMFS does not believe that retention of Pacific halibut or salmon heads and guts for meal constitutes sufficient potential for revenue to undermine the intent of the PSD program. Rather, concern continues to be focused on prohibiting the sale, trade or barter of edible flesh. Therefore, NMFS intends to propose regulations that would clarify the conditions under which parts of prohibited species may be retained by a processor in a manner that would not undermine the intent of the PSD program.”
This action amends the PSD program regulations at 50 CFR 679.26(d) to allow processors to convert offal from salmon or halibut that has been prepared for the PSD program into fish meal, fish oil, or bone meal, and retain the proceeds from the sale of these products. This action was described in the proposed rule published May 5, 2004 (69 FR 25056). Comments on the proposed rule were invited through June 4, 2004, and are summarized and responded to below. The final rule remains unchanged from the proposed rule.
Three letters of comment were received on the proposed rule that contained eight unique comments. Comments are summarized and responded to here.
Currently, research is being conducted by several countries, including the United States, under the Bering-Aleutian International Salmon Survey (BASIS). One research component of the BASIS program is to conduct biological and stock identification analyses designed to determine growth and life history characteristics of regional salmon stocks. Although results of this research initiative are not yet available, the stock identification analysis will be based on genetic, parasite, scale, otolith, and tag data collected over 5 years of international cooperative research cruises. Extensive information on the BASIS program can be found a
NMFS will continue to work internally to obtain necessary data through data collection programs to meet the needs of scientists. Any new or accelerated data collections, including those required for genetic analyses, would need to be prioritized and balanced with available funding and many existing and ongoing management and stock assessment data collections.
Incidental catch of non target groundfish also occurs and often is unavoidable. In recognition of this, NMFS and the Council have adopted management measures designed to create incentives to avoid bycatch when possible and to decrease regulatory and economic discards when it is not.
This final rule has been determined to be not significant for purposes of Executive Order 12866.
The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this action would not have a significant economic impact on a substantial number of small entities. NMFS received one comment, addressed above, regarding this certification. This comment did not cause NMFS to change its determination regarding the certification.
Alaska, Fisheries, Recordkeeping and reporting requirements.
16 U.S.C. 773
(d) * * *
(3) Authorized distributors and persons conducting activities supervised by authorized distributors may retain prohibited species only for the purpose of processing and delivering the prohibited species to hunger relief agencies, food networks or food distributors as provided by this section. Such persons may not consume or retain prohibited species for personal use and may not sell, trade or barter, or attempt to sell, trade or barter any prohibited species that is retained under the PSD program, except that processors may convert offal from salmon or halibut that has been retained pursuant to the PSD program into fish meal, fish oil, or bone meal, and sell or trade these products.
Bureau of Economic Analysis, Commerce.
Notice of proposed rulemaking.
This proposed rule would amend regulations that set forth reporting requirements for the BE-80, Benchmark Survey of Financial Services Transactions Between U.S. Financial Services Providers and Unaffiliated Foreign Persons.
The BE-80 survey is conducted once every five years by the Bureau of Economic Analysis (BEA), U.S. Department of Commerce, under the International Investment and Trade in Services Survey Act and under the Omnibus Trade and Competitiveness Act of 1988. The proposed benchmark survey will be conducted for 2004. The data are needed to compile the U.S. international transactions, national income and product, and input-output accounts; support U.S. economic policy; assess U.S. competitiveness in international trade in services; and improve the ability of U.S. businesses to identify and evaluate market opportunities.
The proposed rule would change the reporting of data on international transactions in financial services by: Creating a new category for brokerage services related to equities transactions; collecting total receipts and total payments for financial services transactions with affiliated foreign parties (that is, with foreign affiliates and foreign parents); and revising the definition of a financial services provider to more fully align the definition with the North American Industry Classification System—2002.
Comments on this proposed rule will receive consideration if submitted in writing on or before October 26, 2004.
You may submit comments, identified by RIN 0691-AA51, and referencing the agency name (Bureau of Economic Analysis), by any of the following methods:
•
•
•
•
•
Public Inspection: Comments may be inspected at BEA's offices, 1441 L Street, NW., Room 7006, between 8:30 a.m. and 5 p.m., Monday through Friday.
Obie G. Whichard, Chief, International Investment Division (BE-50), Bureau of Economic Analysis, U.S. Department of Commerce, Washington, DC 20230; phone (202) 606-9800.
This proposed rule would amend 15 CFR part 801.11 to set forth reporting requirements for the BE-80, Benchmark Survey of Financial Services Transactions Between U.S. Financial Services Providers and Unaffiliated Foreign Persons. The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
The BE-80, Benchmark Survey of Financial Services Transactions Between U.S. Financial Services Providers and Unaffiliated Foreign Persons, is mandatory and is conducted every 5 years by the Bureau of Economic Analysis (BEA), U.S. Department of Commerce, under the International Investment and Trade in Services Survey Act (22 U.S.C. 3101-3108)—hereinafter, “the Act,” and under Section 5408 of the Omnibus Trade and Competitiveness Act of 1998 (15 U.S.C. 4908). BEA will send the survey to potential respondents in January 2005, and a response will be due by March 31, 2005. BEA proposes the following changes to the Code of Federal Regulations: (1) Break the category for brokerage services into two categories, by collecting information on services related to equities transactions separately from other brokerage services; (2) add questions covering total receipts and total payments for transactions in financial services with affiliated foreign parties (
The Bureau of Economic Analysis (BEA), U.S. Department of Commerce, will conduct the survey under the International Investment and Trade in Services Survey Act (22 U.S.C. 3101-3108)—hereinafter, “the Act,” and under Section 5408 of the Omnibus Trade and Competitiveness Act of 1998 (15 U.S.C. 4908). Section 4(a) of the Act (22 U.S.C. 3103(a)) provides that the President shall, to the extent he deems necessary and feasible, conduct a regular data collection program to secure current information related to international investment and trade in services and publish for the use of the general public and the United States Government agencies periodic, regular, and comprehensive statistical information collected pursuant to this subsection. In Section 3 of Executive Order 11961, as amended by Executive Order 12518, the President delegated the authority under the Act as concerns international trade in services to the
The major purposes of the survey are to compile the U.S. international transactions, national income and product, and input-output accounts; support U.S. international economic policy; assess U.S. competitiveness in international trade in financial services; and improve the ability of U.S. businesses to identify and evaluate market opportunities.
The survey is intended to cover the universe of financial services transactions between U.S. financial services providers and foreign persons. Reporting is required from U.S. financial services providers who have sales to or purchases from unaffiliated foreign persons in all financial services combined in excess of $3 million during the reporting year. Financial services providers meeting these criteria must supply data on the amount of their sales or purchases with unaffiliated foreign persons for each type of covered service, disaggregated by country, and must report transactions with foreign affiliates and foreign parents at the global level for both total sales and total purchases of the covered financial services. U.S. financial services providers that have covered transactions of $3 million or less during the reporting year are asked to provide voluntary estimates of their total sales and total purchases of each type of financial service.
This proposed rule has been determined to be not significant for purposes of E.O. 12866.
This proposed rule does not contain policies with Federalism implications as that term is defined in E.O. 13132.
This proposed rule contains a collection-of-information requirement subject to review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA). The requirement has been submitted to OMB for approval as a reinstatement, with change, of a previously approved collection for which approval has expired under OMB control number 0608-0062.
Notwithstanding any other provision of law, no person is required to respond to, nor shall a person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection displays a currently valid Office of Management and Budget control number. The survey, as proposed, is expected to result in the filing of reports from approximately 375 respondents. The respondent reporting burden for this collection of information is estimated to vary from less than four hours to 150 hours, with an overall average burden of 8 hours. This includes time for reviewing the instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Thus, the total respondent burden of the survey is estimated at 3,000 hours (375 responses times 8 hours average burden).
Comments are requested concerning: (a) Whether the proposed collection of information is necessary for the proper performance of the agency, including whether the information will have practical utility; (b) the accuracy of the 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. Comments should be addressed to: Director, Bureau of Economic Analysis (BE-1), U.S. Department of Commerce, Washington, DC 20230; and either faxed (202-395-7245) or e-mailed (
The Chief Counsel for Regulation, Department of Commerce, has certified to the Chief Counsel for Advocacy, Small Business Administration, under the provisions of the Regulatory Flexibility Act (5 U.S.C. 605(b)), that this proposed rulemaking, if adopted, will not have a significant economic impact on a substantial number of small entities. Although BEA does not collect data on total sales or other measures of the overall size of the businesses that respond to the survey, historically the respondent universe has been comprised mainly of major U.S. corporations. With the exemption level for the survey being $3 million for all covered receipts or for all covered payments, the reporting threshold for this survey is set at a level that will exempt most small businesses from reporting. Of those smaller businesses that must report, most will tend to have specialized operations and activities and thus will be likely to report only one type of service transaction, often limited to transactions with a single partner country; therefore, the burden on them can be expected to be small.
International transactions, Economic statistics, Foreign trade, Penalties, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, BEA proposes to amend 15 CFR Part 801, as follows:
1. The authority citation for 15 CFR Part 801 is revised to read as follows:
5 U.S.C. 301; 15 U.S.C. 4908; 22 U.S.C. 3101-3108; and E.O. 11961, January 19,1977 (as amended by E.O. 12318, August 21, 1981, and E.O. 12518, June 3, 1985).
2. Section 801.11(b) and (c) are revised to read as follows:
(b)
(c)
Coast Guard, DHS.
Notice of proposed rulemaking.
The Coast Guard proposes to establish special local regulations during the “Cambridge Offshore Challenge”, a marine event to be held over the waters of the Choptank River at Cambridge, Maryland. These special local regulations are necessary to provide for the safety of life on navigable waters during the event. This action is intended to restrict vessel traffic in the Choptank River during the event.
Comments and related material must reach the Coast Guard on or before September 16, 2004.
You may mail comments and related material to Commander (oax), Fifth Coast Guard District, 431 Crawford Street, Portsmouth, Virginia 23704-5004, hand-deliver them to Room 119 at the same address between 9 a.m. and 2 p.m., Monday through Friday, except Federal holidays, or fax them to (757) 398-6203. The Auxiliary and Recreational Boating Safety Branch, Fifth Coast Guard District, maintains the public docket for this rulemaking. Comments and material received from the public, as well as documents indicated in this preamble as being available in the docket, will become part of this docket and will be available for inspection or copying at the above address between 9 a.m. and 2 p.m., Monday through Friday, except Federal holidays.
Dennis Sens, Project Manager, Auxiliary and Recreational Boating Safety Branch, at (757) 398-6204.
We encourage you to participate in this rulemaking by submitting comments and related material. If you do so, please include your name and address, identify the docket number for this rulemaking (CGD05-04-147), indicate the specific section of this document to which each comment applies, and give the reason for each comment. Please submit all comments and related material in an unbound format, no larger than 8
In order to provide notice and an opportunity to comment before issuing an effective rule, we are providing a shorter than normal comment period. A 20-day comment period is sufficient to allow those who might be affected by this rulemaking to submit their comments because the regulations have a narrow, local application, and there will be local notifications in addition to the
We do not now plan to hold a public meeting. But you may submit a request for a meeting by writing to the address listed under
On September 26, 2004, the Chesapeake Bay Powerboat Association will sponsor the “2004 Cambridge Offshore Challenge”, on the waters of the Choptank River at Cambridge, Maryland. The event will consist of approximately 50 offshore powerboats conducting high-speed competitive races between the Route 50 bridge and Chancellor Point. A fleet of approximately 250 spectator vessels is expected to gather nearby to view the competition. Due to the need for vessel control during the event, vessel traffic will be temporarily restricted to provide for the safety of participants, spectators and transiting vessels.
The Coast Guard proposes to establish temporary special local regulations on specified waters of the Choptank River. The temporary special local regulations will be enforced from 10:30 a.m. to 5:30 p.m. on September 26, 2004, and will restrict general navigation in the regulated area during the event. Except for participants and vessels authorized by the Coast Guard Patrol Commander, no person or vessel will be allowed to enter or remain in the regulated area. These regulations are needed to control vessel traffic during the event to enhance the safety of participants, spectators and transiting vessels.
This proposed rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS).
We expect the economic impact of this proposed rule to be so minimal that a full Regulatory Evaluation under the
Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this proposed rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.
The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities. This proposed rule would affect the following entities, some of which might be small entities: The owners or operators of vessels intending to transit or anchor in a portion of the Choptank River during the event.
This proposed rule would not have a significant economic impact on a substantial number of small entities for the following reasons. This proposed rule would be in effect for only a limited period. Vessel traffic will be able to transit the regulated area between heats, when the Coast Guard Patrol Commander deems it is safe to do so. Before the enforcement period, we will issue maritime advisories so mariners can adjust their plans accordingly.
If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule so that they can better evaluate its effects on them and participate in the rulemaking. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the address listed under
This proposed rule would call for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this proposed rule under that Order and have determined that it does not have implications for federalism.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
This proposed rule would not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
This proposed rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this proposed rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and would not create an environmental risk to health or risk to safety that might disproportionately affect children.
This proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
We have analyzed this proposed rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.
The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (
This proposed rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.
We have analyzed this proposed rule under Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(h), of the Instruction, from further environmental documentation. Special local regulations issued in conjunction with a regatta or marine parade permit are specifically excluded from further analysis and documentation under that section.
Under figure 2-1, paragraph (34)(h), of the Instruction, an “Environmental Analysis Check List” and a “Categorical Exclusion Determination” are not required for this rule. Comments on this section will be considered before we make the final decision on whether to categorically exclude this rule from further environmental review.
Marine Safety, Navigation (water), Reporting and recordkeeping requirements, Waterways.
For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 100 as follows:
1. The authority citation for part 100 continues to read as follows:
33 U.S.C. 1233; Department of Homeland Security Delegation No. 0170.1.
2. Add a temporary § 100.35-T05-147 to read as follows:
(a)
(b)
(2) The operator of any vessel in the regulated area must:
(i) Stop the vessel immediately when directed to do so by any Official Patrol.
(ii) Proceed as directed by any Official Patrol.
(iii) Unless otherwise directed by the Official Patrol, operate at a minimum wake speed not to exceed six (6) knots.
(c)
Coast Guard, DHS.
Notice of proposed rulemaking.
The Coast Guard proposes to change the regulations that govern the operation of the Norfolk Southern #7 Railroad Bridge across the Southern Branch of the Elizabeth River at Atlantic Intracoastal Waterway mile 5.8, in Chesapeake, Virginia. The proposed rule would increase vessel openings and eliminate the need for a bridge tender by allowing the bridge to be operated from a remote location. This change will provide for the reasonable needs of navigation.
Comments and related material must reach the Coast Guard on or before October 26, 2004.
You may mail comments and related material to Commander (obr), Fifth Coast Guard District, Federal Building, 4th Floor, 431 Crawford Street, Portsmouth, Virginia 23704-5004, or they may be hand delivered to the same address between 8 a.m. and 4 p.m., Monday through Friday, except Federal Holidays. The telephone number is (757) 398-6222. The Commander (obr), Fifth Coast Guard District maintains the public docket for this rulemaking. Comments and material received from the public, as well as documents indicated in this preamble as being available in the docket, will become part of this docket and will be available for inspection or copying at the above address.
Bill Brazier, Bridge Management Specialist, Fifth Coast Guard District, at (757) 398-6422.
We encourage you to participate in this rulemaking by submitting comments and related material. If you do so, please include your name and address, identify the docket number for this rulemaking (CGD05-04-117), indicate the specific section of this document to which each comment applies, and give the reason for each comment. Please submit all comments and related material in an unbound format, no larger than 8
We do not now plan to hold a public meeting. But you may submit a request for a meeting by writing to the Commander, Fifth Coast Guard District at the address under
Norfolk Southern Corporation (NSC) requested a change to the current operating regulation set out in 33 CFR Part 117.5 that requires the drawbridge to open promptly and fully for the passage of vessels when a request to open is given.
NSC proposes to remotely control the opening and closing of the Norfolk Southern (NS) #7 Railroad Bridge across the Southern Branch of the Elizabeth River at Atlantic Intracoastal Waterway
This change is being requested to make the closure process of the NS #7 Railroad Bridge more efficient. It will save operational costs by eliminating bridge tenders, and is expected to decrease maintenance costs. In addition, the draw being left in the open position most of the time will provide for greater flow of vessel traffic than the current regulation.
The Coast Guard proposes to amend the regulations governing the NS #7 Railroad Bridge across the Southern Branch of the Elizabeth River, at AICW mile 5.8, which currently opens on signal. The Coast Guard proposes to insert this new specific regulation at 33 CFR 117.997(e).
A new paragraph (e) would contain the proposed rule for the NS #7 Railroad Bridge, at AICW mile 5.8, in Chesapeake. The rule would allow the drawbridge to be remotely controlled by the off-site remote operator at the NS #5 Railroad Bridge office across the Eastern Branch of the Elizabeth River, at mile 1.1, in Norfolk. The drawbridge would be left in the open position to vessels and would only close for the passage of trains and to perform periodic maintenance authorized in accordance with subpart A of part 117.
Before the NS #7 Railroad Bridge closes for any reason, the remote operator will monitor waterway traffic in the area with closed circuit cameras and motion sensors mounted on the bridge. The bridge would only be closed if the off-site remote operator's visual inspection shows that the channel is clear and there are no vessels transiting in the area.
While the NS #7 Railroad Bridge is moving from the full open position to the full closed position, the off-site remote operator will maintain constant surveillance of the navigation channel to ensure that no conflict with maritime traffic exists. In the event of failure or obstruction, the off-site remote operator will stop and return the bridge to the full open position to vessels. In these situations, a bridge tender must be called and on-site within 30 minutes to operate the bridge.
During span movement, the channel traffic lights would change from flashing green to flashing red, the horn will sound twice, and an audio voice warning device will announce bridge movement, then two repeat blasts of the horn until the bridge is seated and locked down. When the bridge is seated and locked down to vessels, the channel traffic lights will flash red.
When the rail traffic has cleared, the horn will automatically sound five times to indicate that the draw of the NS #7 Railroad Bridge is about to return to its full open position to vessels. During the open span movement, the channel traffic lights would flash red, the horn will sound twice, followed by a pause, and then five repeat blasts of the horn until the bridge is in the full open position to vessels. In the full open position to vessels, the bridge channel traffic lights will turn from flashing red to flashing green then an audio warning device will announce bridge movement by stating “Security, security, security, the NS #7 Railroad Bridge at mile 5.8 is open for river traffic”. After the train has cleared the bridge by leaving the track circuit, any delay in opening of the draw to vessels shall not exceed ten minutes except as provided in 33 CFR 117.31(b). Operational information will be provided 24 hours a day on marine channel 13 and via telephone (757) 924-5320.
The Coast Guard proposes to revise § 117.997 by redesignating paragraphs (e) through (i) and inserting a new paragraph (e). Text modifications to be consistent with other proposed changes will be made in these paragraphs, as appropriate.
This proposed rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS).
We expect the economic impact of this proposed rule to be so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is unnecessary. We reached this conclusion based on the fact that the proposed changes for the NS #7 Railroad Bridge regulation will provide for greater flow of vessel traffic than the current regulations of the drawbridge.
Under the current regulations, the NS #7 Railroad Bridge remains closed and opens only on signal to vessels. The proposed regulation will require the bridge to remain in the open position permitting vessels to pass freely. The bridge will close only for train crossings and bridge maintenance. This proposed regulation will provide for the reasonable needs of navigation.
Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this proposed rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.
The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities.
This proposed rule would not have a significant economic impact on a substantial number of small entities for the following reasons. The rule will provide for the NS #7 Railroad Bridge to remain in the open position, allowing for the free flow of vessel traffic. The bridge would only close for the passage of trains and maintenance.
If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule so that they can better evaluate its effects on them and participate in the rulemaking process. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact
This proposed rule would call for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this proposed rule under that Order and have determined that it does not have implications for federalism.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
This proposed rule would not affect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
This proposed rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this proposed rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and would not create an environmental risk to health or risk to security that might disproportionately affect children.
This proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
We have analyzed this proposed rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.
The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (
This proposed rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.
We have analyzed this proposed rule under Commandant Instruction M16475.1D, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (32)(e) of the Instruction, from further environmental documentation.
Bridges.
For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 117 as follows:
1. The authority citation for part 117 continues to read as follows:
33 U.S.C. 499; Department of Homeland Security Delegation No. 0170.1; 33 CFR 1.05-1(g); section 117.255 also issued under the authority of Pub. L. 102-587, 106 Stat. 5039.
2. In § 117.997, redesignate paragraphs (e) through (i) as paragraphs (f) through (j) respectively, and add a new paragraph (e) to read as follows:
(e) The draw of the Norfolk Southern #7 Railroad Bridge, mile 5.8 in Chesapeake, shall operate as follows:
(1) The draw shall be remotely controlled by the operator at the Norfolk Southern #5 Railroad Bridge office over the Eastern Branch of the Elizabeth River, at mile 1.1, in Norfolk.
(2) The draw shall be left in the open position to vessels and will only be closed for the passage of trains and to perform periodic maintenance authorized in accordance with subpart A of this part.
(3) Trains shall be controlled so that any delay in opening of the draw shall not exceed ten minutes except as provided in § 117.31(b).
(4) Before the bridge closes for any reason, the off-site remote operator will monitor waterway traffic in the area with closed circuit cameras and motion sensors mounted on the bridge. The bridge would only be closed if the off-site remote operator's visual inspection shows that the channel is clear and there are no vessels transiting in the area.
(5) While the bridge is moving from the full open position to the full closed position, the off-site remote operator will maintain constant surveillance of the navigation channel to ensure that no conflict with maritime traffic exists. In the event of failure or obstruction, the off-site remote operator will stop and return the bridge to the full open position to vessels. In these situations, a bridge tender must be called and on-
(6) During closing of the span, the channel traffic lights would change from flashing green to flashing red, the horn will sound twice, and an audio voice warning device will announce bridge movement, then two repeat blasts of the horn until the bridge is seated and locked down. When the bridge is seated and locked down to vessels, the channel traffic lights will flash red.
(7) During the open span movement, the channel traffic lights would flash red, the horn will sound twice, followed by a pause, and then five repeat blasts of the horn until the bridge is in the full open position to vessels. In the full open position to vessels, the bridge channel traffic lights will turn from flashing red to flashing green then an audio warning device will announce bridge movement by stating “Security, security, security, the Norfolk Southern #7 Railroad Bridge at mile 5.8 is open for river traffic”.
(8) Operational information will be provided 24 hours a day on marine channel 13 and via telephone (757) 924-5320.
Centers for Medicare & Medicaid Services (CMS), HHS.
Correction of proposed rule.
This document corrects a technical error that appeared in the proposed rule published in the
Joel Cohen, (410) 786-3349.
In FR Doc. 04-16791 of July 23, 2004 (69 FR 43956), there was a technical error that is identified and corrected in the Correction of Errors section below.
We inadvertently omitted the correct
In FR Doc. 04-16791 of July 23, 2004 (69 FR 43956), make the following correction:
1. On page 43956, in the third column; in the second paragraph, replace the
In commenting, please refer to file code CMS-6146-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
You may submit comments in one of three ways (no duplicates, please):
1.
2.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.
We ordinarily publish a notice of proposed rulemaking in the
We find it unnecessary to undertake notice and comment rulemaking because this notice merely provides a technical correction to the regulation. Therefore, we find good cause to waive notice and comment procedures.
Centers for Medicare & Medicaid Services (CMS), HHS.
Proposed rule.
This proposed rule would require State agencies to estimate improper payments in the Medicaid program and SCHIP program. The Improper Payments Information Act of 2002 requires Federal agencies to annually review and identify those programs and activities that may be susceptible to significant erroneous
The intended effect and expected results of this proposed rule would be for States to produce improper payment estimates for their Medicaid and SCHIP programs and to identify existing and emerging vulnerabilities that can be addressed by the States through actions taken to reduce the rate of improper payments and produce a corresponding increase in program savings at both the State and Federal levels.
To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on September 27, 2004.
In commenting, please refer to file code CMS-6026-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
You may submit comments in one of three ways (no duplicates, please):
1.
2.
Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-6026-P, P.O. Box 8017, Baltimore, MD 21244-8017.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
(Because access to the interior of the HHH Building is not readily available to persons without Federal Government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)
Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.
For information on viewing public comments, see the beginning of the
Christine Saxonis, (410) 786-3722.
Janet E. Reichert, (410) 786-4580.
The Improper Payments Information Act of 2002 (Pub. L. 107-300, enacted on November 26, 2002) requires Federal agencies to annually review and identify those programs and activities that may be susceptible to significant erroneous payments, estimate the amount of improper payments, and report those estimates to the Congress and, if necessary, submit a report on actions the agency is taking to reduce erroneous payments. Under the Improper Payments Information Act, “improper payment” is defined as (a) any payment made that should not have been made or that was made in an incorrect amount (including overpayments and underpayments) under statutory, contractual, administrative, or other legally applicable requirements; and (b) includes any payment to an ineligible recipient; any payment for an ineligible service; any duplicate payment; payments for services not received; and any payment that does not account for credit for applicable discounts. Under the statute, the term “payment” means any payment (including a commitment for future payment, such as a loan guarantee) that is (a) made by a Federal agency, a Federal contractor, or a governmental or other organization administering a Federal program or activity; and (b) derived from Federal funds or other Federal resources or that will be reimbursed from Federal funds or other Federal resources.
The law applies with respect to improper payments made in fiscal years after fiscal year (FY) 2002 and requires inclusion of improper payment estimates for fiscal years after FY 2003.
To comply with the Improper Payments Information Act, the Secretary must estimate improper payments made under Medicare, Medicaid, and the State Children's Health Insurance Program (SCHIP). We have been estimating improper payments in the Medicare program since 1996 as part of the annual Chief Financial Officer's audit conducted by the Office of Inspector General. However, no systematic means of measuring overall program payment errors at the State and national levels currently exists for Medicaid and SCHIP. Since the Medicaid and SCHIP programs are administered by State agencies according to each State's unique program characteristics, State involvement in estimating improper payments is necessary for the Secretary to comply with the provisions of the Improper Payments Information Act.
The Improper Payments Information Act directed the Office of Management and Budget (OMB) to provide subsequent guidance. OMB defines significant erroneous payments as annual erroneous payments in the program exceeding both 2.5 percent of program payments and $10 million. For all programs and activities susceptible
• The estimate of the annual amount of erroneous payments.
• A discussion of the causes and actions taken to correct the causes.
• A discussion of the amount of actual erroneous payments the agency expects to recover.
• Limitations that prevent the agency from reducing the erroneous payment levels, that is, resources, or legal barriers.
Title XIX of the Social Security Act (the Act) authorizes States to provide health care services to low-income individuals and families through the Medicaid program. The Medicaid program is funded through Federal/State partnership whereby the State sets its own eligibility standards, benefit packages, and payment rates within broad Federal guidelines. In FY 2002, Medicaid program expenditures for health care services alone were $246 billion (not including administrative expenditures).
Title XXI of the Act authorizes States to initiate and expand the provision of child health assistance to uninsured, low-income children. Under title XXI, States may provide child health assistance primarily for obtaining health benefits coverage through the following:
• A separate child health program that meets the requirements specified under section 2103 of the Act; or
• Expansion of eligibility for benefits under the State's Medicaid plan under title XIX of the Act; or
• A combination of the two approaches.
SCHIP is jointly financed by the Federal and State governments and is administered by the States. Each State determines the design of its program, eligibility groups, benefit packages, payment levels for coverage, and administrative and operating procedures. SCHIP provides a capped amount of funds to States on a matching basis for Federal FYs 1998 through 2007. In 1997, the Congress appropriated nearly $40 billion over 10 years to help States expand health care coverage to uninsured children. Over 5.3 million children were enrolled in SCHIP nationwide in FY 2002.
In FY 2000, we developed the PAM project to explore the feasibility of developing a method to estimate improper payments for the Medicaid program in response to the Government Performance and Results Act of 1993 (GPRA), Public Law No. 103-62, (1993). We will refer to the method to estimate improper payments as Payment Error Rate Measurement (PERM) in this proposed rule. We will use the term PAM in this discussion to describe the research and development project that was the precursor to PERM.
The PAM model uses a claims-based sample and review methodology and has been designed to estimate a State-specific payment error rate that is within +/−3 percent of the true population error rate with 95 percent confidence. Moreover, through weighted aggregation, the State-specific estimates can be used to make national level improper payment estimates for the Medicaid and SCHIP programs.
In the first year of the PAM Project, nine States voluntarily tested methodologies intended to produce State-specific improper payment estimates. From these tested methodologies and best practices, from the nine States, we developed the PAM model both to produce a State-specific payment accuracy rate that is within +/−3 percent of the true population accuracy rate with 95 percent confidence and to provide us with both the uniformity and precision to estimate improper payments at the national level while maintaining sufficient flexibility to enable States to produce State-specific estimates. In the second year, the PAM model was modified to conform to the Improper Payments Information Act of 2002 by including improper payments attributable to underpayments, overpayments, and improper payments attributable to ineligible beneficiaries. Twelve States tested the PAM model in their Medicaid fee-for-service and managed care programs. The second year test identified problem areas that needed resolution, produced project time savers, administrative tips, and realistic cost estimates that helped us to refine the PAM model for the third year. In the third year, 27 States are testing the PAM model; 11 States in Medicaid, 3 States in SCHIP, and 13 States in both programs. Each State will identify improper payments due to overpayments, underpayments, and payments made to ineligible persons in fee-for-service and/or managed care settings for both programs.
Since each State's Medicaid and SCHIP programs are unique in their program characteristics, it is critical that States provide us with State-specific improper payment estimates under the PERM program so we can estimate improper payments at the national level for these programs. With the challenges States are facing due to budget constraints and staffing shortages, it is unlikely that all States would voluntarily implement the current PAM model even though Federal and State program savings would be realized as a result of actions taken by the States to address problem areas identified through the process of estimating improper payments. However, the Secretary is required by the Improper Payments Information Act of 2002 to annually review all programs and activities (including Medicaid and SCHIP) to determine whether these programs are susceptible to significant improper payments and, because of the differences in the Medicaid and SCHIP programs nationwide, we must rely on State-specific information in order to make this determination.
Current law at section 1102 of the Act authorizes the Secretary to establish regulations as may be necessary to the efficient administration of the Medicaid and SCHIP programs. Medicaid law at section 1902(a)(6) of the Act and SCHIP law at section 2107(b)(1) of the Act require States to provide information necessary for the Secretary to monitor program performance. Through these statutory provisions, this proposed rule would require States to provide the Secretary with the information needed to monitor program performance by:
• Measuring improper payments in the Medicaid and SCHIP programs; and
• Providing State level improper payment estimates to the Secretary for calculating a national level improper payment estimate.
We believe the basic PAM model being pilot tested by many States can be implemented nationwide under the PERM program. The PAM model would effectively provide all States with the method needed to produce State-specific improper payment estimates on which we can base the national improper payment estimates needed to
This proposed rule would enable the Secretary to comply with the requirements under the Improper Payments Information Act by producing a national improper payment estimate for the Medicaid and SCHIP programs using the State-specific estimates reported by the States. This proposed rule would allow the Secretary to monitor State performance in administering the Medicaid and SCHIP programs and maintain an overview of Medicaid and SCHIP improper program expenditures in an efficient manner.
This proposed rule builds upon the PAM model and proposes requirements that States must meet to produce State-specific improper payment estimates and report those estimates to the Secretary for the purpose of computing a national improper payment estimate. We plan to release guidance addressing any immediate questions States may have after reviewing the provisions of the final regulations within 60 days of the effective date of the regulation followed by detailed instructions describing the methods and procedures for estimating the payment error rate as necessary. However, we formally invite States to comment on the specific information they will need to implement the PERM program before the final regulation is published. We also will be seeking ways to solicit State input regarding the guidance so that States will know how to prepare for program implementation. The provisions of this proposed rule would be set forth in a new 42 CFR (Code of Federal Regulations) part 431, subpart Q and in part 457, subpart G as follows:
This proposed rule would require States to estimate, on the annual October through September Federal fiscal year basis, annually total improper payments and produce payment error rates in Medicaid and SCHIP using the PERM methodology. This proposed rule also would require States to provide these estimates to CMS by June 1 of the following year for the purpose of CMS reporting a national estimate of improper payments in those programs to OMB by November 15. This timeline will allow OMB to compile the information in the Department's Performance and Accountability Report to the Congress. In conducting medical records reviews and eligibility reviews, States must adhere to the requirements of protection of recipient rights including those in § 435.901 and § 435.902.
We propose a process for estimating improper payments in both Medicaid and SCHIP in each State and the District of Columbia annually. From these State-level estimates, a national estimate of improper payments in each program will also be estimated. We propose to exclude the Territories from these regulatory requirements because the funding for the Medicaid and SCHIP programs is minimal, is subject to specific limits on Federal financial participation for each Territory, and inclusion of improper payment estimates for the Territories' Medicaid and SCHIP programs in the PERM program would not have an impact on the national error rate estimates for these programs.
Following the initial estimation of the error rate and improper payments, the States would take actions to address problem areas that result in improper payments. Improvement will be tracked over time through the States' annual payment error estimates.
States must also submit an Annual PERM Report to CMS by June 1 following the previously completed sampling period. The report must list the errors which the State identified in its review (and identify which amounts were overpayments, underpayments, and payments for ineligible individuals/services), explain the causes of the errors and explain the actions it will take to address those errors and to reduce the level of improper payments.
The statutory bases for this subpart are sections 1102, 1902(a)(6), and 2107(b)(1) of the Act, which authorize the Secretary to make rules and regulations necessary to the efficient administration of the Medicaid and SCHIP programs and require States to provide information, as the Secretary may need, to monitor program performance.
In addition, this rule would support the Improper Payments Information Act of 2002 which requires Federal agencies to—
• Review annually and identify those programs and activities that may be susceptible to significant erroneous payments;
• Estimate the amount of improper payments; and
• Report those estimates to the Congress and, if necessary, submit a report on actions the agency is taking to reduce erroneous payments.
This proposed rule would require States under the current statutory provisions as stated in paragraph (a) of this section and in support of the Improper Payments Information Act to estimate improper payments using the PERM methodology for the Medicaid and SCHIP programs on an annual basis. The States are further required to submit payment error rates to CMS for the purpose of calculating a national level payment error rate.
This provision in the proposed rule would ensure the consistency of State estimates of improper payments through the monthly sample and review of Medicaid and SCHIP claims in which Federal funds were paid for services furnished in both the fee-for-service and managed care settings. The PERM methodology requires sampling from the Medicaid universe and SCHIP universe, reviewing sampled claims, and reporting results. Using specified formulas, the improper payment estimate for each program is based on the gross total of overpayments and underpayments (that is, the absolute value rather than the net value) and payments to ineligibles. The estimate is also within +/−3 percent of the true population error rate with 95 percent confidence.
In § 431.958, we propose the following definitions and use of terms for part 431, subpart Q:
In § 431.962, we propose that the State plan would implement the PERM program for estimating the payment error rate in both Medicaid and SCHIP annually; the State would submit those estimates to the Secretary by June 1 following the most recently completed annual error rate estimation for the purpose of CMS calculating and reporting a national payment error rate for these programs to OMB by November 15. This timeline is necessary for OMB to compile the information in the Department's Performance and Accountability Report to the Congress.
In § 431.966, we propose that State collection and review of documentation for the purpose of conducting payment error rate measurement must be done in a manner that is consistent with the rights of recipients including those required under § 435.901 and § 435.902.
In § 431.970, we propose that States must submit to the Secretary payment error rates for both Medicaid and SCHIP annually. Payment error rates would be estimated based upon the documentation review of a random sample of paid and denied claims/line items drawn from the universe of claims from each program. The payment error rate estimate must meet the required precision level in each program.
The goal of PERM is to produce a State-level estimate of the Medicaid error rate and the SCHIP error rate that meets or exceeds required precision levels and that also can be aggregated to a national level error rate for each program. Within both the Medicaid and the SCHIP program, separate monthly samples should be drawn for fee-for-service claims or line items and managed care or insurance premium payments, if applicable to the State. Separate estimates of a fee-for-service error rate and managed care error rate will be estimated from these samples for each program, as applicable to the State. The precision level at either the fee-for-service or managed care level can be lower than the precision requirements at the State's program level for Medicaid and for SCHIP. However, when the separate estimates for the State's fee-for-service and managed care samples are combined into an overall error rate at the State's program level, the estimate should meet or exceed the precision requirements specified for the program level estimate.
States would estimate improper Medicaid and SCHIP payments using the PERM methodology and report error rates to the Secretary annually. We would use the State level estimates to produce estimates of improper payments for both Medicaid and SCHIP at the national level. All States would use the State findings to address error causes that result in improper payments in their Medicaid and SCHIP programs in order to reduce the rate of improper payments in those programs.
The Medicaid claims universe will consist of all Medicaid fee-for-service (FFS) adjudicated claims/line items paid to providers, insurers, and managed care organizations and that were denied for payment to providers, insurers, and managed care organizations in which the State claimed title XIX matching Federal funds. The universe includes all monthly managed care capitation payments made to health care organizations under a Medicaid managed care plan or a premium payment made to an insurer on behalf of a Medicaid beneficiary. Because we are reviewing only claims submitted by providers, insurers, and managed care organizations for which a decision to pay or deny was made by Medicaid or SCHIP, the universe would not include any non-claims-based payments or claims returned to providers because of submission errors. Examples of non-claims-based payments to providers are disproportionate share payments and aggregate cost settlement payments.
The SCHIP claims universe consists of all fee-for-service SCHIP adjudicated claims/line items paid to providers and that were denied for payment for which the State claimed SCHIP enhanced Federal funding under title XXI, along with all capitation payments made to health care organizations, or premium payments to insurers on behalf of SCHIP recipients.
For fee-for-service SCHIP programs that are Medicaid Expansion programs, the SCHIP claims for which enhanced Federal funds were either paid or denied under title XXI must be separated from those Medicaid claims either paid or denied with title XIX Medicaid matching funds. These claims would be added to claims or payments from other fee-for-service SCHIP programs the State may offer, with the total constituting the universe for fee-for-service SCHIP.
If the State has both a separate fee-for-service SCHIP program and a Medicaid expansion that is fee-for-service, the claims from both would be pooled for sampling purposes.
Medicaid capitated payments would consist of capitated premium payments for managed care enrollees paid to health care maintenance organizations (HMOs) or providers for which Federal funds were claimed. These payments would be considered as if they were “claims,” similar to fee-for-service claims, for the purpose of forming the sampling universe for Medicaid.
SCHIP capitated payments and premium payments to insurers for both Medicaid expansions and separate child health programs are also considered as if they were “claims,” similar to fee-for-service claims, for the purpose of forming the sampling universe for SCHIP.
We do not consider monthly management fees paid to primary care physicians under a primary care case management program as capitation payments. Those payments, however, should be considered as fee-for-service claims for the purpose of estimating improper payments.
The sample must be drawn from a universe of all claims paid in the annual period October 1 through September 30. The monthly sample must be drawn from paid and denied claims/line items made through the 12-month sampling period as estimated to result in approximately the same number of claims to be reviewed each month. We anticipate each State will have an annual sample size ranging from 800-1200 claims for each program. The State-specific estimates of improper payments would be used to calculate the national estimate for the Federal fiscal year. States must submit a sampling plan to CMS for approval 30 days before the beginning of the sample period. CMS will respond to the States' sampling plan submittals in a timely manner. The State must receive approval for a plan before it can be implemented. If an approved plan is unchanged from a previous sampling period, the State is not required to resubmit the plan for approval. However, once the basic structure of the sample process is approved and implemented, all States are required at the beginning of each sample period to make the necessary updates and/or adjustments due to fluctuations in the universe as enrollment numbers change that result in the appropriate sample size. States are not required to submit these minor plan updates/adjustments to CMS for approval before implementation.
For the Medicaid and SCHIP program, the sample size would be drawn to obtain an estimate of the payment error rate that is within +/−3 percentage points of the true population payment error rate, with 95 percent confidence for each of the two programs. However, if the State has both a fee-for-service and a managed care component to its Medicaid or SCHIP programs, a sample stratified between the fee-for-service and managed care components must be drawn for each program. To contain costs, however, the required minimum precision levels for the samples at the component level are reduced. If both a fee-for-service and a managed care sample are drawn for Medicaid or for SCHIP, the fee-for-service estimate and the managed care estimate may, individually, satisfy a lower precision requirement. Specifically, if both a fee-for-service and a managed care sample are drawn for Medicaid or for SCHIP, the sample size of each component individually should be sufficient to achieve a precision level of +/−4 percentage points of the true error rate for the fee-for-service or managed care population, at a confidence level of 90 percent. The separate component level estimates will then be combined to produce a single program level estimate for Medicaid and for SCHIP. Regardless of the required minimum precision requirements at the component level, samples' sizes must be sufficient at the fee-for-service and/or managed care component level when combined to meet Medicaid and SCHIP program level precision requirements. The State will report estimates for both the Medicaid and SCHIP program levels and the FFS and managed care component levels.
States sometimes make a correction or “adjustment” to a claim to correct an inaccuracy in the original claim payment. These adjustments could be made to correct the billing amount, coding, or other items. In reviewing claims, an adjustment to any claim that affects the payment amount would be reviewed if the adjustment occurred within 60 calendar days after the payment adjudication date. Adjustments to claims before to 60 days of the payment adjudication date would not be reviewed nor would claims adjustments be sampled as a separate sample unit.
In § 431.982, we propose that the review for FFS claims would differ slightly from those of capitated claims or premium payments. The following describes the review procedures for fee-for-service claims. The review would consist of processing validation, eligibility, and medical review.
Each line item would be reviewed to validate that it was processed correctly, based on the information that is on the claim. At the minimum, review the claim to determine if it is:
• A duplicate item (claim);
• A non-covered service;
• A service covered by an HMO (that is, beneficiary is enrolled in a managed care organization that should have covered the service);
• Subject to third party liability payment;
• An invalid price;
• A logic edit (for example, incompatibility between gender and procedure); or
• Data entry (clerical) errors.
The eligibility review documents that the beneficiary was eligible for Medicaid or SCHIP at the time the service was received through case record review and field investigation. During the case record review, specific facts are collected about the circumstances of the beneficiary. The field investigation is required to verify the information. The determination of beneficiary eligibility is accomplished by applying the State's Medicaid or SCHIP eligibility policies in effect as of
The eligibility verification review would generally follow the procedures established by Medicaid Eligibility Quality Control (MEQC) [§ 431.812 (e)(1) through (e)(4)] except that States must not apply the administrative period. The administrative period is a timeframe under the MEQC program that provides a reasonable period of time for States to reflect changes in the beneficiary's circumstances without an error being cited. The administrative period is the sample month and month before the sample month. When an eligibility error occurs during this time because the beneficiary's circumstances changed (for example, income increased), no eligibility error exists (as long as the case would otherwise be eligible except for this error) because the agency did not have enough time to react to the change and correct the case. We propose to exclude the administrative period in the PERM regulation because it is resource-intensive to review eligibility for both months to determine if the error occurred during that time and that the change in circumstances is the sole reason for the error. We also believe that the intent of the PERM program is to focus on eligibility only at the time the service was received. Therefore, under the PERM rule, the month the service was received is the only month that States would review beneficiary eligibility and the administrative period would not apply.
Medicaid law at section 1902(a)(10)(A)(i)(I) of the Act requires States to make medical assistance available to individuals receiving aid or assistance under title XVI. Under section 1634 of the Act, the Social Security Administration (SSA) may enter into an agreement with any State under which the SSA will determine the Medicaid eligibility of Supplemental Security Income (SSI) cash recipient cases. In a State with such an agreement with the SSA, the State must verify Medicaid eligibility by confirming, through the State Data Exchange, that the beneficiary was an SSI recipient for the month the Medicaid service was provided.
Eligibility reviews would determine that the beneficiary was eligible for Medicaid in the month the sampled service was provided (or on the date of service in States that do not provide full-month coverage). Eligibility reviews would also be conducted for the SCHIP sample in the same manner the reviews are conducted for the Medicaid sample. Individual cases found with an error that could affect eligibility should be reported to the appropriate unit for action.
We propose that medical record requests to providers via mail are sufficient. At the minimum, the medical review would include review of—
• The guidelines and policy related to the claim;
• Medical record documentation;
• Medical necessity; and
• Coding accuracy.
Each capitation payment and premium payment would be Reviewed to validate that it was processed correctly. The review would include the following:
• Data entry error.
• Invalid pricing.
• Duplicate item (claim).
Moreover, if the plan includes a capitation payment or premium that varies depending upon the characteristics of the recipient (risk-adjusted payments, for example) the review must determine that the precise capitated payment or premium payment was accurate for that recipient. In some cases, this may require some clinical expertise.
In § 431.986, we propose that the eligibility review of recipients on whose behalf a capitated payment or premium was paid is the same as that for recipients for fee-for-service claims. That is, the State would verify that the beneficiary was eligible for Medicaid or SCHIP, as appropriate, in the month the service was received (or the date of service in States that do not provide full month coverage) by verifying that the beneficiary met the categorical and financial eligibility requirements according to the State's eligibility policies in effect in the month in which the service was received. In addition, however, the review must determine if the recipient was eligible and actually enrolled for the particular health care plan for which the premium was made.
Unlike fee-for-service claims, there is no explicit medical review of a particular service.
In § 483.990, we propose that States must report, annually, improper payment estimates to the Secretary by June 1, 9 months after the previous October 1 through September 30 sampling period. States must also submit an Annual PERM Report to CMS by June 1 following the previously completed sampling period. The report must list the errors which the State identified in its review (and identify which amounts were overpayments, underpayments, and payments for ineligible individuals/services), explain the causes of the errors and explain the actions it will take to address those errors and to reduce the level of improper payments.
We also propose that, for purposes of this regulation, States retain documentation to support the testing and statistical calculation of the Medicaid and SCHIP PERM error rate estimates, particularly statistical, fiscal, and other records necessary for reporting and accountability as required by the Secretary. For those records that pertain to the PERM program, we propose that States maintain and permit ready access and use of those records, including but not limited to the eligibility case records, review materials, working papers, reports, sampling plans, and statistical data and all other documentation needed to support the State's Medicaid and SCHIP error rates. These records may be used for Federal re-review or audits by the Department of Health and Human Services (DHHS), HHS Office of the Inspector General and the Government Accountability Office. Similarly, for purposes of this regulation, we propose that States retain these records for 3 years from the date of submission of a final expenditure report or beyond 3
OMB guidance for implementing the Improper Payments Information Act requires us to include in our report to the Congress a discussion regarding recovery of misspent funds. We propose to include a provision that States would return to us within 60 days the Federal share identified as overpayments actually identified in the sampled claims reviewed for data processing and medical necessity in accordance with 42 CFR part 433, subpart F. Payments based on erroneous eligibility determinations are exempt from this provision because these payments are addressed under section 1903(u) of Act.
We propose to revise § 457.720 to make a conforming change to cross-reference § 431.950 through § 431.1002 in order to make it easy for States to find the rules governing the PERM program.
Under the Paperwork Reduction Act of 1995, we are required to provide 60-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.
We are soliciting public comment on each of these issues for the following sections of this document that contain information collection requirements:
In summary, § 431.962 requires State plans to provide for the submission of payment error rate estimates for both Medicaid and SCHIP to the Secretary.
The burden associated with this requirement would be 51 (the number of States and the District of Columbia that need to amend their State Plan to include this requirement) × 1 (the hours it would take for them to amend the plan), or 51 hours annually.
The information collection for amending State Plans is currently approved under OMB number 0938-0193.
This assumes that all States would conduct PERM as required by the regulation. Therefore, the State plan would be amended in all 50 States plus the District of Columbia. Amending the State plan requires 1 hour in order for the State to sign and submit an additional form with their plan that outlines what the State is required to do under the PERM regulation; the form does not require preparation by State.
Section 431.970(a) requires States to submit payment error rates for both Medicaid and SCHIP annually.
The burden associated with this requirement would be the time it would take each State to gather and calculate the data using the PERM methodology, for both Medicaid and SCHIP, and then report their payment error rates findings to the Secretary.
It is estimated that it would take 24,000 hours per State to comply with this requirement, or a total of 1,224,000 hours (# of States × hours/State). This assumes that during any given Federal fiscal year beginning with FY 2006, a maximum of 50 States plus the District of Columbia will be conducting PERM as required by this proposed rule. This further assumes that each of the 51 participating States will be conducting PERM on a sample of approximately 2,000 paid/denied claims/line items. Each sampled claim reviewed under PERM generally requires 12 hours as follows: 10 hours for eligibility verification case review, 1 hour for medical records review and processing validation, and 1 hour of administrative/professional time. Therefore, 2,000 claims (×) 12 hours per claim equals 24,000 hours per State (×) 51 States per year equals 1,224,000 total hours per year.
Section 431.978 requires States to submit initial sampling plans for CMS for approval 30 days before implementation. The burden associated with this requirement is the time it takes each State to develop a sampling plan. Based on the cost efficiency study from the second year of the PAM research and demonstration project, we estimate that it will take approximately 84 hours to develop a sampling plan for sampling a total average of 1,000 to 2,000 claims. The total burden is 84 hours per program = 168 per State (×) 51 States = 8,568 hours. If a plan is unchanged from a previous period, the State is not required to resubmit the plan for approval. Once States have established an approved sampling plan, they may need to make minor adjustments to maintain the proper sample size but do not need to obtain CMS approval for these minor changes.
Section 431.990(a) requires States to annually report the total estimated improper payments and payment error rates to the Secretary.
The burden associated with this requirement is the time it takes each State to annually gather the total estimated improper payments and payment error rates and report this to the Secretary by June 1. The burden associated with this requirement is included in the burden under the payment error rate requirements in § 431.970.
Section 431.990(b) requires States to submit an Annual PERM Report to CMS.
The burden associated with this is the time it will take for the States to prepare the report that addresses actions to be taken to address error causes and that are designed to reduce payment error and submit this report to CMS. It is estimated that it will take a State 40 hours to prepare and submit the report to CMS. The burden associated with this requirement would be 51 (the number of States and the District of Columbia) × 40 hours (the hours it would take for each State to prepare the report) or 2040 hours. The cost associated with preparing the Annual PERM Report for each State is $1040. That amount is based on a State employee hourly wage figure computed at 80 percent of a GS 12/Step 1 salary plus 10 percent retirement/insurance as follows: $60,638 (GS 12) + $6063 (10 percent retirement/insurance) × 80 percent = $53,360/2080 hours per year = $26 per hour (rounded). $26 per hour × 40 hours = $1040 51 States × $1040 = $53,040 total annual State cost (applicable Federal match is available).
For purposes of maintenance of records, we propose that States retain
If you comment on these information collection and recordkeeping requirements, please mail copies directly to the following:
Centers for Medicare & Medicaid Services, Office of Strategic Operations and Regulatory Affairs, Regulations Development and Issuances Group, Attn: Melissa Musotto, Room C5-14-03, 7500 Security Boulevard, Baltimore, MD 21244-1850; and
Office of Information and Regulatory Affairs, Office of Management and Budget, Room 10235, New Executive Office Building, Washington, DC 20503, Attn: Christopher Martin, CMS Desk Officer.
Comments submitted to OMB may also be e-mailed to the following address: e-mail:
Because of the large number of items of correspondence we normally receive on
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 19, 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 ($100 million or more in any 1 year).
Based upon the cost efficiency study from States participating in the second year of the PAM research and demonstration project from which the PERM methodology was developed and pilot tested, we estimate that the average cost, based on an average of 1,000 claims, would be as follows: $570 per eligibility review, $300 per claims review (data processing and medical review), and $155 standard administrative cost. Based on these figures, we estimate that the total annual State and Federal costs to conduct PERM would range from $1 to $2 million. Therefore, we have determined that the proposed rule would not exceed the annual $100 million threshold impact criterion. Therefore, an impact analysis is not required under E.O. 12866.
The RFA requires agencies to analyze options for regulatory relief of small businesses. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and government agencies. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $6 million to $29 million in any 1 year. Individuals and States are not included in the definition of a small entity. The proposed rule would require State governments to estimate payment error in Medicaid and SCHIP using the PERM methodology. State governments are not defined as small entities in the RFA. Therefore, an impact analysis is not required under the RFA.
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 603 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.
The proposed rule applies to State governments and does not apply to small rural hospitals. Therefore, an impact analysis is not required under section 1102(b) of the Social Security Act.
Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule that may result in expenditure in any 1 year by State, local, or tribal governments, in the aggregate, or by the private sector, of $110 million.
As discussed previously, based upon preliminary cost estimates from State participation in the second year of the PAM research and demonstration project from which the PERM methodology was developed and pilot tested, we have estimated that the total computable (State and Federal) cost will range from $1 to $2 million to operate PERM annually. Therefore, we have determined that the proposed rule would not result in expenditures by State, local, or tribal governments, in the aggregate, or by the private sector that exceed the annual $110 million threshold impact criterion. Therefore, an impact analysis is not required under
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications.
The proposed rule would require States to produce payment error rate estimates using the PERM methodology. The two major cost factors for each State implementing the PERM methodology are the medical review of the sampled claims and the eligibility verification of the beneficiaries associated with the sampled claims. States must conduct medical review of the sampled claims with participation from nurse level staff. States must also conduct field visits to obtain documentation and interview beneficiaries, if necessary, in order to verify eligibility. The labor costs and travel costs associated with these staff would vary by State. These costs are also driven by the size of the claims sample that would vary by State, which we estimate to be 800 to 1,200 per program. Other less significant expenses incurred by States include both the cost of program administration and the cost of professional staff to draw the sample, estimate the payment error rate, and produce reports. We estimate the total computable (State and Federal) cost, based on an average of 1,000 claims, will be an average of $870,000 to conduct the reviews and $155,000 in administrative expenses for a total range of $1 to $2 million.
Preliminary cost estimates were based on a cost analysis of States' participating in the research and demonstration project from which the PERM methodology was developed and pilot tested. From this analysis, we estimate that States should be able to conduct PERM annually for between $1 to $2 million, with most States at the lower end of that range, which includes the applicable Medicaid and SCHIP Federal match.
This proposed rule is intended to produce savings for the States. These savings would result from actions taken by the States to address error causes identified in the claims processing system and other program areas, as appropriate. These savings cannot be estimated until after each State has conducted PERM for successive years in order that reductions in payment error rates can be reported and potential savings to the State can be estimated.
The State may request that medical providers supply medical records or other similar documentation that verify the provision of medical services to a beneficiary, for a paid or denied Medicaid or SCHIP claim that was sampled and reviewed for payment error as part of PERM. This action would not have a significant cost impact on medical providers.
The PERM methodology has been designed to promote savings for the Medicaid and SCHIP programs by reducing payment error. We would like to solicit comments on how to implement the PERM methodology at the State level in a manner that ensures independence and minimizes conflicts of interest.
The PERM methodology has been developed and pilot tested with extensive collaboration from participating States during a 3-year research and demonstration project. Alternatives were considered and pilot tested during the research and demonstration project period. We considered having CMS or a contractor use the PERM methodology to construct national improper payment estimates annually for Medicaid and SCHIP. We rejected this approach because no single Federal entity or contractor is expert in the unique eligibility, service, coverage, and reimbursement policies of every State. Also, in State-administered programs like Medicaid and SCHIP, the State itself must identify error causes, based on PERM reviews, and take actions to reduce the level of improper payments.
We considered a process for estimating improper payments in both Medicaid and SCHIP through a rotation process whereby each State would participate in a sample and review of claims for each program once every 3 years. This was rejected because of concern that excluding some States from the sampling frame in a given year may bias the national estimate.
Randomly sampling States each year to produce a national estimate was also considered. It was rejected because it would not provide an estimate for each State on a systematic basis. Consequently, CMS would not be able to routinely monitor individual State progress and provide technical assistance to achieve error reduction.
The draft final specifications of the methodology have been developed in collaboration with the participating States. The methodology has also been designed to minimize costs to the States and to be in compliance with the requirements of the Improper Payments Information Act of 2002 and the related guidance from the Office of Management and Budget.
In accordance with E.O. 12866, this proposed rule was reviewed by the Office of Management and Budget.
Grant programs—health, Health facilities, Medicaid, Privacy, Reporting and recordkeeping requirements.
Administrative practice and procedure, Grant programs—health, Health insurance, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services proposes to amend 42 CFR chapter IV as set forth below:
1. The authority citation for part 431 continues to read as follows:
Sec. 1102 of the Social Security Act (42 U.S.C. 1302).
2. Part 431 is amended by adding new subpart Q to read as set forth below:
This subpart requires States to annually estimate total improper payments and produce payment error rates in Medicaid and SCHIP using the Payment Error Rate Measurement (PERM) methodology and to provide these estimates to the Secretary by June 1 for the purpose of HHS developing a
(a)
(b)
The State plan must—
(a) Provide for estimating the payment error rate in both Medicaid and SCHIP and the respective fee-for-service and managed care components, as applicable; and
(b) Submit payment error rate estimates in both Medicaid and SCHIP to the Secretary by June 1 annually for the purpose of HHS reporting a national payment error rate for these programs.
State collection and review of documentation for the purpose of conducting payment error rate measurement must be done in a manner that is consistent with the rights of recipients including those required under § 435.901 and § 435.902.
(a) States must submit to the Secretary payment error rates for both Medicaid and SCHIP annually.
(b) Payment error rates are estimated based upon the documentation review of a random monthly sample of paid and denied claims/line items drawn from the universe of claims from each program.
(c) The payment error rate estimate must meet the required precision level, as defined in § 431.958, in each program and component.
(a) States must estimate improper Medicaid and SCHIP payments through a review of randomly selected claims.
(b) States must take actions in their Medicaid and SCHIP programs to address causes of errors identified through the claims reviews.
(c) States must submit an Annual PERM Report to CMS by June 1 following the sample year. The Annual PERM Report must detail the causes of error (identified through the PERM claims reviews) that result in improper
(a) States must draw a statistically valid random sample from the Medicaid universe and the SCHIP universe, as defined in § 431.958, that is of sufficient size to ensure that it meets the required precision level for each program and component as defined in 431.958.
(b) The sample must be drawn monthly throughout the annual sampling period.
(c) For a State with both a fee-for-service and managed care component to its Medicaid and/or SCHIP program, a sample stratified between these components must be drawn for each program. Component sample sizes must be sufficient, when combined, to meet the Medicaid and SCHIP program level precision requirements.
(d) States must submit a sampling plan to CMS for approval 30 days before the beginning of the sample period and must receive approval of the plan before implementation. If a plan is unchanged from a previous period, the State is not required to resubmit the plan for approval.
(e) States must make minor updates and adjustments to the plan due to fluctuations in the universe as enrollment numbers change that results in appropriate sample sizes. States are not required to obtain CMS approval for these minor changes.
(a)
(1) Processing Validation. At minimum, review the claim to determine if it is—
(i) A duplicate item (claim);
(ii) A non-covered service;
(iii) A service covered by an HMO (that is, the beneficiary is enrolled in a managed care organization that should have covered the service);
(iv) Subject to third party liability payment;
(v) An invalid price;
(vi) A logic edit (for example, incompatibility between gender and procedure); or
(vii) A data entry (clerical) error.
(2)
(i) In a State that confers Medicaid or SCHIP eligibility on a month-to-month basis, the review must verify that the beneficiary was eligible for the Medicaid or SCHIP program during the month the service was received by applying the State's policies and procedures in effect during that month.
(ii) In a State with day-specific Medicaid or SCHIP eligibility, the review must verify that the beneficiary was eligible for the Medicaid or SCHIP program on the date the service was received by applying the State's policies and procedures in effect on that date.
(iii) The eligibility verification review must follow the procedures established by Medicaid Eligibility Quality Control, as set forth in § 431.812(e)(1) through (e)(4), except that States must not apply the administrative period. In-person interviews are optional unless verification of eligibility cannot be made based on the case record review and appropriate documentation or collateral contacts.
(iv) In States with agreements with the Social Security Administration under section 1634 of the Act, the State must verify Medicaid eligibility by confirming, through the State Data Exchange, that the beneficiary was a Supplemental Security Income (SSI) cash recipient for the month or the date the Medicaid service was received.
(v) States must take appropriate action on individual error cases that could affect eligibility.
(3)
(i) The guidelines and policy related to the claim;
(ii) Medical record documentation;
(iii) Medical necessity; and
(iv) Coding accuracy.
(b) [Reserved]
(a) The eligibility review of recipients on whose behalf a capitated payment or premium was paid is the same as that for recipients for fee-for-service claims.
(b) The review must verify that the recipient was eligible for and actually enrolled in the particular health care plan for which the premium or capitation payment was made. If the plan includes a capitation payment or premium that varies depending upon the characteristics of the recipient, the review must verify that the precise capitated payment or premium payment was accurate for that recipient.
(c)
(1) A duplicate item (claim);
(2) A non-covered service;
(3) A service covered by an HMO (that is, the beneficiary is enrolled in a managed care organization that should have covered the service);
(4) Subject to third party liability payment;
(5) An invalid price;
(6) A logic edit (for example, incompatibility between gender and procedure); or
(7) A data entry (clerical error).
(d) Medical records review is not required as part of the review of capitated payments.
(e) The claims review includes adjustments to claims that occur within 60 calendar days after the payment adjudication date.
(a) States must annually report total estimated improper payments and payment error rates to the Secretary by June 1 following the close of the sampling period.
(b) States must submit an Annual PERM Report to CMS by June 1 following the close of the sample period. The report must list the errors which the State identified in its review (and identify which amounts were overpayments, underpayments, and payments for ineligible individuals/services), explain the causes of the errors and explain the actions it will take to address those errors and to reduce the level of improper payments.
(c) States must retain documentation to support the testing and statistical calculation of the Medicaid and SCHIP error rate estimates, particularly statistical, fiscal, and other records necessary for reporting and accountability as required by the Secretary.
(d) States must maintain and permit ready access and use of all official records used for purposes of the PERM Report, including but not limited to the eligibility case records, review materials, working papers, reports, sampling plans, and statistical data and all other documentation needed to support the State's Medicaid and SCHIP error rates. These records may be used for Federal re-review or audits by the Department of Health and Human Services, HHS Office of the Inspector General and the Government Accountability Office.
(e) States must retain these records for 3 years from the date of submission of a final expenditure report or beyond 3 years if audit findings have not been resolved.
States must return to CMS the Federal share of overpayments identified in the sampled claims reviewed for data processing and medical necessity within 60 days in accordance with section 1903(d)(2) of the Act and related regulations at part 433, subpart F of this chapter. Payments based on erroneous eligibility determinations are exempt from this provision because they are addressed under section 1903(u) of the Act and related regulations at part 431, subpart P of this chapter.
3. The authority citation for part 457 continues to read as follows:
Section 1102 of the Social Security Act (42 U.S.C. 1302).
2. Section 457.720 is revised to read as follows:
A State plan must include an assurance that the State collects data, maintains records, and furnishes reports to the Secretary, at the times and in the standardized format the Secretary may require to enable the Secretary to monitor State program administration and compliance and to evaluate and compare the effectiveness of State plans under title XXI. This includes collection of data and reporting as required under § 431.950 through § 431.1002 of this chapter.
Federal Communications Commission.
Proposed rule.
In this document, the Commission proposes to amend the rules for fixed, point-to-point microwave service in the 38.6-40.0 GHz (“39 GHz”) band, and to adopt a conforming set of new rules for the virtually unused 37.0-38.6 GHz (“37 GHz”) band in order to allow for the expansion of 39 GHz type service. In this Third Notice of Propose Rule Making, (Third NPRM), we propose service rules for the 37 GHz and also for the 42.0-42.5 GHz (“42 GHz”) (“37/42 GHz”) bands that would substantially conform to the rules adopted for the 39 GHz band in the
Comments are due on or before October 26, 2004, and reply comments are due to be filed by November 26, 2004. Written comments on the Paperwork Reduction Act proposed information collection requirements must be submitted by the public, Office of Management and Budget (OMB), and other interested parties on or before October 26, 2004.
In addition to filing comments with the Secretary, a copy of any comments on the Paperwork Reduction Act information collection requirements contained herein should be submitted to Judith B. Herman, Federal Communications Commission, Room 1-C804, 445 12th Street, SW., Washington, DC 20554, or via the Internet to
Charles Oliver (legal) or Michael Pollak (engineering), Wireless Telecommunications Bureau, (202) 418-2487. For additional information concerning the Paperwork Reduction Act information collection requirements contained in this document, contact Judith B. Herman at (202) 418-0214, or via the Internet at
This is a summary of the Commission's Third NPRM, released on May 5, 2004, (FCC 04-78). The full text of the Third NPRM is available for inspection and copying during normal business hours in the FCC Reference Center, Room CY-A257, 445 12th St., SW., Washington DC 20554. The complete text may also be purchased from the Commission's duplicating contractor, Best Copy and Printing Inc., (BCPI), Portals II, 445 12th St., SW., Room CY-B402, Washington DC. Additionally, the complete item is available on the Commission's Web site at
1. In the Notice of Proposed Rule Making and Order that initiated the above-captioned proceeding in 1995, we proposed to amend the rules for fixed, point-to-point microwave service in the 38.6-40.0 GHz (“39 GHz”) band, and to adopt a conforming set of new rules for the virtually unused 37.0-38.6 GHz (“37 GHz”) band in order to allow for the expansion of 39 GHz-type service. In this Third NPRM, we propose service rules for the 37 GHz and also for the 42.0-42.5 GHz (“42 GHz”) (“37/42 GHz”) bands that would substantially conform to the rules adopted for the 39 GHz band in the
2. Significant changes in spectrum allocations, technology, and market conditions have occurred since the adoption of the 39 GHz rules and auction. Consequently, we invite comments on all of the unresolved issues in this proceeding. We do not seek comment on issues that were decided in the allocation item in the
• We propose to license the 37/42 GHz bands on a geographic basis using Economic Areas ( EAs ), consistent with the licensing scheme adopted for the 39 GHz band, but we invite comment on alternative approaches as well. Specifically, we invite comment on the possibility of authorizing service using a first-in-time site registration process.
• We propose to permit point-to-point, point-to-multipoint, and future mobile operations.
• We propose to adopt a “substantial service” build-out requirement if the band is licensed using EA licenses, but we invite comment on alternative build-out requirements if we adopt a different licensing scheme.
• We propose technical rules designed to provide licensees with operational flexibility.
• We propose to permit 37/42 GHz band licensees to partition and disaggregate spectrum if the band is licensed by EAs.
• We seek comment on whether to adopt a channeling plan for the 37/42 GHz bands, and, if so, what plan to propose.
• We propose to require coordination whenever and wherever facilities have optical radio line-of-sight into another licensee’s geographic area or registered site license.
• We seek comment on the appropriate coordination method to employ between adjacent licensees and with the Federal government. We propose to apply these changes to the 39 GHz band as well as the 37/42 GHz bands.
• If we license the bands by EAs when awarding 37/42 GHz licenses, we propose to use the competitive bidding procedures set out in part 1, subpart Q of our rules.
As required by the Regulatory Flexibility Act (“RFA”) of 1980, the Commission has prepared an Initial Regulatory Flexibility Analysis (“IRFA”), with respect to this
This document contains proposed information collection requirements. The Commission, as part of its continuing effort to reduce paperwork burdens, invites the general public and the Office of Management and Budget (OMB) to comment on the information collection requirements contained in this document, as required by the Paperwork Reduction Act of 1995, Public Law 104-13. Public and agency comments are due October 26, 2004. Comments should address: (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 estimates; (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. In addition, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198,
1. For purposes of this permit-but-disclose notice and comment rulemaking proceeding, members of the public are advised that
1. Pursuant to §§ 1.415 and 1.419 of the Commission's rules, 47 CFR 1.415, 1.419, interested parties may file comments on or before September 27, 2004, and reply comments on or before October 12, 2004. Comments may be filed using the Commission's Electronic Comment Filing System (“ECFS”) or by filing paper copies.
2. Comments filed through the ECFS can be sent as an electronic file via the Internet to
1. For further information concerning this rulemaking proceeding, contact Charles Oliver (legal) or Michael Pollak (engineering) at (202) 418-2487, TTY (202) 418-7233, Wireless Telecommunications Bureau, Federal Communications Commission, Washington, DC 20554.
2. Alternative formats (computer diskette, large print, audio cassette, and Braille) are available to persons with disabilities by contacting Brian Millin at (202) 418-7426, TTY (202) 418-7365, or via e-mail to
4. As required by the Regulatory Flexibility Act of 1980, as amended (RFA), the Commission has prepared this present Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on a substantial number of small entities by the policies and rules proposed in this Third NPRM. Written public comments are requested on this IRFA. Comments must be identified as responses to the IRFA and must be filed by the deadlines for comments on this Third NPRM provided in Section IV, (Procedural Matters), of the item. The Commission will send a copy of the Third NPRM, including this IRFA, to the Chief Counsel for Advocacy of the Small Business Administration. In addition, the Third NPRM and IRFA (or summaries thereof) will be published in the
5. This rulemaking action is being undertaken to propose a licensing plan, a channeling plan, certain technical rules, and competitive bidding procedures for the 37.0-38.6 and 42.0-42.5 (“37/42”) GHz spectrum bands. Currently, there are no such rules in place for these bands. Our objective is to facilitate spectrum aggregation, equipment development and service planning, and otherwise to create rules that will maximize efficient use of these bands, and that are in the public interest. We note specifically that, as described below, we propose to provide bidding credits to small and very small businesses.
6. The proposed action is authorized under Sections 1, 4(i), 7, 301, 303, 308 and 309(j) of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154(i), 157, 301, 303, 308, 309(j).
7. The RFA requires that an initial regulatory flexibility analysis be prepared for notice and comment rulemaking proceedings, unless the Agency certifies that “the rule will not, if promulgated, have a significant impact on a substantial number of small entities. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A “small business concern” is one which: (i) Is independently owned and operated; (ii) is not dominant in its field of operation; and (iii) satisfies any additional criteria established by the Small Business Administration (SBA). A small organization is generally “any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.” This IRFA describes and estimates the number of small entity licensees that may be affected if the proposals in this Third NPRM are adopted.
8. When identifying small entities that could choose to participate in an auction and be affected by our new rules, we provide information describing auctions results, including the number of small entities that are winning bidders. We note, however, that the number of winning bidders that qualify as small businesses at the close of an auction does not necessarily reflect the total number of small entities currently in a particular service. The Commission does not generally require, post-auction, that applicants provide business size information, except in the context of an assignment or transfer of control application where unjust enrichment issues are implicated. Consequently, to assist the Commission in analyzing the total number of potentially affected small entities, we request commenters to estimate the number of small entities that may be affected by any rule changes resulting from this Third NPRM.
9.
10.
11.
12. The SBA has developed a small business size standard for wireless small
13. The Commission created a special small business size standard for 39 GHz licenses “ an entity that has average gross revenues of $40 million or less in the three previous calendar years. An additional size standard for “very small business” is: an entity that, together with affiliates, has average gross revenues of not more than $15 million for the preceding three calendar years. The SBA has approved these small business size standards. The auction of the 2,173 39 GHz licenses began on April 12, 2000 and closed on May 8, 2000. The 18 bidders who claimed small business status won 849 licenses. Consequently, the Commission estimates that 18 or fewer 39 GHz licensees are small entities that may be affected by the rules and polices proposed herein.
14. Generally, all applicants are required to seek authorizations to construct and operate and to adhere to the technical criteria set out in the final rules. However, this Third NPRM proposes service rules and auction rules for the 37.0-38.6 GHz band and the 42.0-42.5 GHz band (“37/42 GHz bands”) either by a geographic area licensing approach or the first-come, first-served link-by-link registration approach, in order to coordinate spectrum use that will affect reporting, recordkeeping and other compliance requirements. Each of these changes is described below:
15. The Third NPRM proposes to require users in the 37/42 GHz bands to coordinate procedures with the National Telecommunications and Information Administration (NTIA) in negotiations with non-Government and Government stations in the band and that these negotiations would apply the geographic area licensing regulatory framework. However, independent of the licensing approach the Commission chooses, the basic coordination procedures with NTIA will be the same because they are based on a site-by-site method, consistent with Section IV(6) of the Memorandum of Understanding (MOU) between the Commission and NTIA dated January 31, 2003, wherein the Commission and NTIA would maintain current lists of authorized frequency assignments on the ULS and the Government Master File (GMF) and exchange information as appropriate to coordinate spectrum use. Also, the site-based coordination procedures proposed here involve coordination between the Interdepartment Radio Advisory Committee (IRAC), Commission licensees, and Government agencies through the Commission, which represents the non-Government facilities, and the NTIA, which represents the Government agencies. Problems would be referred by the Commission back to its licensees/applicants and by the NTIA to Government agencies for resolution.
16. The Third NPRM proposes to require non-Government operators/licensees in the 37.0-38.6 GHz frequency band to maintain databases of their fixed stations, including sufficient data for other licensees, coordinators, and the Government to make a determination of potential interference. Non-Government licensees would have the option of maintaining their own databases for their facilities or of selecting third-party database managers, frequency coordinators, or other entities to maintain their database of facilities. The database manager would be responsible to the licensee and would share the technical data with the Commission and other database managers as needed for proper coordination, and retain records of the coordination agreements with other parties. All coordination agreements would remain in force in the event the licensee transfers its license, partitions its service area, or disaggregates its spectrum, until new agreements are reached.
17. The Third NPRM proposes to require the non-Government operators/licensees to make available all necessary technical database information to the Commission in a timely and convenient manner sufficient for resolving interference complaints with NTIA in the event of disputes. The Third NPRM also proposes to require non-Government licensees to register their technical data electronically into the ULS for each station in their authorized service areas in order to make available accurate information with Government facilities such as, the date of the initial operating capability of each station, specific information identifying the station locations, technical operating capabilities of the stations, and, if known, whether the station has optical line-of-site to another facility with which it is being coordinated. This site-based information would be entered into the record of the area license in the ULS database by electronically registering notifications to the initial Commission Form 601 using Schedule I, but not more than twelve (12) months before operations are scheduled to begin. The Third NPRM also proposes that notification and response for site-by-site coordination for geographic area licensees requires variations in the general coordination procedures as given in Section 101.103 of our rules. The Third NPRM further proposes that geographic area licensees must select site frequencies within their assignment blocks of spectrum and initiate the coordination process by notifying the other parties with whom they must coordinate and that registrations of licensee sites on Schedule I of Form 601 must include the licensees determination of whether possible optical line-of-site exists to relevant (future) Government facilities. If it is determined that optical line-of-site does not exists, the applicant is required to explain the determination. Coordination involving existing and future Government facilities would require licensees and applicants to ensure that their data is accurately reflected in ULS.
18. The Third NPRM also proposes that licensees would be required to follow existing practices and precedents regarding fees associated with initial licenses, and to file notifications in the ULS to supply the technical information needed to coordinate each station with Government facilities. When revisions to ULS are developed for adding the capability to handle licensees in the 37.0-38.6 GHz band, the capability to collect this additional site-based information for notifications would be added to the capability to handle “initial” auction winners as licensees.
19. The Third NPRM proposes to conduct an auction of initial exclusive area licenses in the 37/42 GHz band which would be required to conform with general competitive bidding rules set out in part 1, subpart Q, of our rules, substantially consistent with the bidding procedures that have been employed in previous auctions, and specifically, rules governing competitive bidding design, designated entities, application and payment procedures, reporting requirements, collusion issues, and unjust enrichment. In this connection, the Third NPRM also would
20. The RFA requires an agency to describe any significant, specifically small business, alternatives that it has considered in reaching its proposed approach, which may include the following three alternatives (among others): “(i) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (ii) the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities; (iii) the use of performance, rather than design, standards; and (iv) an exemption from coverage of the rule, or any part thereof, for small entities.”
21. In the Third NPRM, we propose service and auction rules for the 37/42 GHz bands in order to establish a flexible regulatory and licensing framework that would promote seamless deployment of a host of services and technologies. We seek comment on the possibility of conducting an auction—where applications are mutually exclusive and issuing exclusive licenses for the 37/42 GHz bands on a geographic basis. We believe that our proposed approach would provide a variety of businesses with the opportunity to participate in an auction of licenses in this band and afford licensees substantial flexibility for the provision of services with varying capital costs. We also believe that geographic area licensees in these bands would be presented with issues and costs similar to those presented to 39 GHz band licensees, including those involved in developing markets, technologies, and services. Smaller service areas make it easier for small businesses to bid successfully for licenses, but viable businesses may require larger service areas. We believe that the technical rules that apply to the 39 GHz band would also be appropriate for the 37/42 GHz bands, if we decide to adopt a geographic area licensing approach. It would be inappropriate to apply the 70/80/90 GHz technical rules to the 37/42 GHz bands because the bands differ significantly from each other. Because the 37/42 GHz band has such a large amount of spectrum, license portions of these blocks by Economic Areas (EAs) or other portions on a site-by-site basis could be other alternatives. By using this combined approach to licensing, the Commission may address the needs of large entities, as well as smaller businesses, including public safety entities. Therefore, we also seek comment on the benefits of having some spectrum licensed by geographic areas and some spectrum licensed on a site-by-site basis. As an alternative, we could also pair some of the channels in the 37.0-38.6 GHz portion with some of the channels in the 42.0-42.5 GHz portion or allocate channel sizes of 30 or 40 megahertz or even smaller. Perhaps smaller channels might allow for smaller businesses and private entities to effectively compete for spectrum needed for more limited applications without needing to obtain a larger amount of spectrum that would require substantial outlays of initial investment. We hope that these alternatives, which might especially affect small entity participation in the auction, will be addressed by commenters.
22. We note that if we adopt a geographic area licensing framework, we propose to permit 37/42 GHz licensees to partition and disaggregate spectrum freely within those bands. These options tend to assist small entities. For the geographic area approach, we propose to allow partitioning of any licensee-defined service area, disaggregation of any amount of spectrum and combined partitioning and disaggregation. The Third NPRM proposes to permit the 37/42 GHz bands to partition and disaggregate spectrum if the Commission adopts a geographic area licensing framework using EAs by competitive bidding and through private negotiation and agreement. Our Part 1 unjust enrichment provisions would govern partitioning and disaggregation arrangements involving licenses authorized to small businesses afforded a bidding credit, including those that later elect to partition or disaggregate their licenses to an entity that is not eligible for the same bidding credit. In addition, Section 309(j)(3)(B) of the Communications Act provides that, in establishing eligibility criteria and bidding methodologies, the Commission shall promote “economic opportunity and competition * * * by avoiding excessive concentration of licenses and by disseminating licenses among a wide variety of applicants, including small businesses, rural telephone companies, and businesses owned by members of minority groups and women.” The Commission concluded in the
23. In contrast, in the
24. Also, as an alternative, and in the interest of regulatory certainty, if we adopt a geographic area licensing structure, we propose to adopt a rule specifically permitting spectrum aggregation. The Commission has also concluded that permitting aggregation of channels might benefit the public through efficiencies and flexibility in the types of services this would allow, and might provide for lower costs or greater ability to compete with established service providers with large transmission capacity. We also propose that 37/42 GHz licensees be allowed to aggregate their spectrum in order to provide greater flexibility of service. In other services, the Commission has adopted a rule expressly permitting aggregation.
25. The Third NPRM proposes competitive bidding procedures if we license bands by EAs when awarding 37/42 GHz licensees set out in part 1, subpart Q of our rules. Small businesses that choose to participate in the competitive bidding for these services and utilize a bidding credit are required to demonstrate that they meet the criteria set out to qualify as small businesses, as required under part 1, subpart Q of the Commission's rules, 47 CFR part 1, subpart Q. We believe that the small business size standards and corresponding bidding credits proposed would provide a variety of businesses with opportunities to participate in the auction of licenses for the 37/42 GHz band and afford licensees substantial flexibility for the provision of services with varying capital costs. We further
None.
Pursuant to sections 1, 4(i), 7, 301, 303, 308 and 309(j) of the Communications Act of 1934, 47 U.S.C. 151, 154(i), 157, 301, 303, 308, 309(j),
The Commission's Consumer and Governmental Affairs Bureau, Reference Information Center,
Reporting and recordkeeping.
Communications Equipment, Radio, and Reporting and recordkeeping.
Communications Equipment, Radio, Reporting and recordkeeping, Satellites, Telecommunications.
For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR parts 0, 2, and 101 as follows:
1. The authority citation for part 0 continues to read as follows:
Sec. 5, 48 Stat 1068, as amended; 47 U.S.C. 155, 225 unless otherwise noted.
2. Section 0.331(d) is amended by revising paragraph (d) introductory text to read as follows:
(d)
1. The authority citation for part 2 continues to read as follows:
47 U.S.C. 154, 302a, 303, and 336, unless otherwise noted.
2. Section 2.106, is amended as follows:
a. Revise pages 76 and 77 of the Table.
b. In the list of United States footnotes, add footnote USxxx.
c. In the list of non-Federal government footnotes, add footnote NGxxx.
The revisions and additions read as follows:
U.S.xxx In the band 37-38 GHz, the following Government receiving earth stations have been coordinated with the FCC and shall be protected from non-operations in the fixed and mobile services in the band 37-38 GHz and from non-Government earth stations in the fixed-satellite service (space-to-Earth) in the sub-band 37.5-38 GHz. Non-Government applications for fixed and mobile service use of frequencies in the band 37-38 GHz shall be coordinated with NTIA through the Frequency Assignment Subcommittee within the following coordination areas/distances. The coordinates listed below are specified in terms of the North American Datum of 1983.
In the band 37-38 GHz, the following stations in the space research service (space-to-Earth) have been coordinated:
NGxxx The use of the band 37.5-40 GHz by the fixed-satellite service (space-to-Earth) is limited to gateway earth station operations as set out in 47 CFR part 25.
1. The authority citation for part 101 continues to read as follows:
47 U.S.C. 154, 303.
2. Section 101.17 is revised to read as follows:
(a) All 37.0-40.0 GHz and 42.0-42.5 GHz band licensees must demonstrate substantial service at the time of license renewal. A licensee's substantial service showing should include, but not be limited to, the following information for each channel for which they hold a license, in each EA or portion of an EA covered by their license, in order to qualify for renewal of that license. The information provided will be judged by the Commission to determine whether the licensee is providing service which rises to the level of “substantial.” Licensees, whether the license was obtained through competitive bidding or partitioning/aggregation/disaggregation, may build facilities anywhere within the authorized service area without further authority from the Commission, provided that they have complied with applicable Commission requirements. The Commission does not require individual licenses for each terrestrial fixed facility.
(1) A description of the 37.0-40.0 GHz, or 42.0-42.5 GHz band licensee's current service in terms of geographic coverage;
(2) A description of the 37.0-40.0 GHz, or 42.0-42.5 GHz band licensee's current service in terms of population served, as well as any additional service provided during the license term;
(3) A description of the 37.0-40.0 GHz, or 42.0-42.5 GHz band licensee's investments in its system(s) (type of facilities constructed and their operational status is required);
(b) Any 37.0-40.0 GHz and 42.0-42.5 GHz band licensees adjudged not to be providing substantial service will not have their licenses renewed.
3. Sections 101.56 is amended by revising paragraphs (a)(1), (a)(2)(ii), (b), (f), (g), (h) and (i) to read as follows:
(a)(1) The holder of an EA authorization to provide service pursuant to the competitive bidding process areas in the 37.0-40.0 GHz and 42.0-42.5 GHz bands and any incumbent licensee of rectangular service areas in the 38.6-40.0 GHz band may enter into agreements with eligible parties to partition any portion of its service area as defined by the partitioner and partitionee. Alternatively, licensees may enter into agreements or contracts to aggregate/disaggregate any amount of spectrum, provided acquired spectrum is aggregated/disaggregated in frequency pairs.
(2) * * *
(a)(2)(ii) The contracts must include descriptions of the areas being partitioned or spectrum being aggregated/disaggregated. The partitioned service area shall be defined by coordinate points at every 3 seconds along the partitioned service area unless an FCC recognized service area is utilized (
(b) The eligibility requirements applicable to EA authorization holders also apply to those individuals and entities seeking partitioned or aggregated/disaggregated spectrum authorizations.
(f) The duties and responsibilities imposed upon EA authorization holders in this part, apply to those licensees obtaining authorizations by partitioning or spectrum aggregation/disaggregation.
(g) The build out requirements for the partitioned service area or aggregated/disaggregated spectrum shall be the same as applied to the EA authorization holder.
(h) The license term for the partitioned service area or aggregated/disaggregated spectrum shall be the remainder of the period that would apply to the EA authorization holder.
(i) Licensees, including those using bidding credits in a competitive bidding procedure, shall have the authority to partition service areas or aggregated/disaggregated spectrum.
4. Subpart B is amended by adding § 101.58 to read as follows:
(a) The licensee in the 37.0-40.0 GHz and 42.0-42.5 GHz bands may construct and operate any number of fixed stations anywhere within the area authorized by the license without prior authorization, except as follows:
(1) A station is required to be individually licensed under part 101 if:
(i) International agreements require coordination;
(ii) Submission of an Environmental Assessment is required under § 1.1307 of this chapter.
(iii) The station would affect the radio quiet zones under § 1.924 of this chapter.
(2) Any antenna structure that requires notification to the Federal Aviation Administration (FAA) must be registered with the Commission prior to construction under § 17.4 of this chapter.
(3) Frequencies in the 37.0-38.6 GHz band are co-primary and shared with the Government. All parties concerned should complete coordination based on a first in time sharing basis and obtain coordination agreements with prior licensed facility operators before operating.
(b) Whenever a licensee constructs or makes system changes as described in
5. Section 101.63 is amended by revising paragraph (a) to read as follows:
(a) Each station, except in Local Multipoint Distribution Services, 24 GHz Service, the 37.0-40.0 GHz and 42.0-42.5 GHz bands, authorized under this part must be in operation within 18 months from the initial date of grant. For the 70 GHz, 80 GHz, and 90 GHz bands, each 18-month construction period will commence on the date of each registration of each individual link; adding links will not change the overall renewal period of the license.
6. Section 101.64 is revised to read as follows:
Service areas for 37.0-40.0 GHz and 42.0-42.5 GHz service are Economic Areas (EAs) as defined below and in effect as of April 12, 2000. EAs are delineated by the Regional Economic Analysis Division, Bureau of Economic Analysis, U.S. Department of Commerce, 1995. The Commerce Department organizes the 50 States and the District of Columbia into 172 EAs. Additionally, there are four EA-like areas: Guam and Northern Mariana Islands; Puerto Rico and the U.S. Virgin Islands; American Samoa and the Gulf of Mexico. A total of 175 authorizations (excluding the Gulf of Mexico EA-like area) will be issued for each channel block in the 37.0-40.0 GHz and 42.0-42.5 GHz bands.
7. Section 101.101 is amended by adding in numerical order to the table entries for “37,000-38,600 MHz” and “42,000-42,500 MHz” and by revising the entry for “38,600-40,000 MHZ” to read as follows:
8. Section 101.103 is amended by revising paragraph (i) and by adding paragraphs (j) and (k) to read as follows:
(i)(1) When fixed microwave or fixed satellite earth station facilities licensed under Part 101 are to be operated in the band 37,000 MHz to 40,000 MHz or 42,000 MHz to 42,500 MHz, the following coordination procedures shall apply:
(i) All harmful interference to other users and blocking of adjacent channel use in the same or adjacent geographical area is prohibited. In areas near the border between two licensees' service areas, careful consideration should be given to minimum power requirements and to the location, height, and radiation pattern of the transmitting antenna. Licensees are expected to cooperate fully in attempting to resolve problems of potential interference before bringing the matter to the attention of the Commission.
(ii) Each licensee must engineer its system to be reasonably compatible with adjacent and co-channel operations in the same or adjacent areas, and cooperate fully and in good faith to resolve whatever potential interference and transmission security problems may be present in adjacent and co-channel operations.
(iii) A licensee shall coordinate its facilities whenever the facilities have optical line-of-sight (calculated using the formula d = 3.57√h, where d is the distance between the antenna and the horizon in kilometers and h is the antenna height in meters) into another licensee s geographic area where that licensee's facilities may be located or into another licensee's facilities within the same or adjacent geographic area, and the power flux density of the licensee's system calculated at the service area boundary of the neighboring service area(s) exceeds −125 dBW/m
(iv) In the event no licensee in the bands 37,000 MHz to 40,000 MHz or 42,000 MHz to 42,500 MHz is immediately available in an adjacent or same area, the first-in-time licensee would have to coordinate its stations when future licensees appear in order to accommodate other licensees' rights and to ensure cooperative and effective use of the spectrum in each area. This may include reducing powers to levels which are agreeable to both parties.
(i)(2) Response to notification should be made as quickly as possible, even if no technical problems are anticipated. Any response to notification indicating potential interference must specify the technical details and must be provided to the licensee, either electronically or in writing, within 10 days of notification. Every reasonable effort should be made by all licensees to eliminate all problems and conflicts. If no response to notification is received within 10 days, the licensee will be deemed to have made reasonable efforts to coordinate and may commence operation without a response. The beginning of the 10-day period is determined pursuant to § 101.103(d)(2)(v).
(i)(3) Licensees shall comply with the appropriate coordination agreements between the United States and Canada and the United States and Mexico concerning cross-border sharing and use
(j)
(1) In the band 37-38 GHz, use of the space research service (space-to-Earth) shall be on a primary basis only at Goldstone, California. Stations in the fixed and mobile services within 80 kilometers (50 miles) of 35° 18′ North Latitude and 116° 54′ West Longitude shall be coordinated through contacting the facility directly. Stations in the 37.0-38.6 GHz band in the vicinity of Green Bank, West Virginia must also coordinate as required by Section 1.924. The interference protection criterion to these facilities is −130 dBW/m
(2) Non-Government licensees in the 37-38.6 GHz band must register their technical data electronically into the ULS for each station in each of their geographic areas in order to make available accurate information on the use of the facilities and also to implement the “first-in-time” principle for coordination with Government facilities. This data shall include: 1) the date of the initial operating capability (IOC) of each station, 2) specific information identifying the station locations, 3) technical operating capabilities of the stations, including all of the power and antenna characteristics specified in Section 101.103(d)(2)(ii) of this section, and 4) whether the station has optical line-of-site to another facility with which it is being coordinated, if known at the time. If it is determined that optical line-of-site does not exist, the applicant should explain the determination. This site-based information shall be entered into the record of the area license in the ULS database by electronically registering notifications to the initial FCC Form 601 using Schedule I, but not more than twelve (12) months before operations are scheduled to begin.
(3) The FCC will note the activation date of the station, but will not make a determination that any of the information is correct or acceptable for filing. Coordination involving current and future Government facilities will require licensees and applicants to ensure that their data is accurately reflected in the ULS.
(4) Government operators with existing facilities in the 37.0-38.6 GHz band should cooperate in the coordination process by responding to non-Government coordination notifications. Government operators with new stations to coordinate can identify and directly access the technical information of the non-Government licensees through the ULS. Examining the data in the ULS before formally coordinating with the FCC in the appropriate frequency band and geographic service area may speed up the frequency selection process. Government operators with new stations should notify the FCC through the IRAC process with sufficient technical detail to determine whether potential interference is possible with facilities of our licensees/applicants.
(5)
(6)
(7)
(k)
9. Section 101.107 is amended by adding footnote 9 to the table in paragraph (a) to read as follows:
(a) * * *
10. Section 101.109 is amended by removing the entry for “38,600-40,000 MHz” and adding in numerical order entries for “37,000-40,000 MHz” and “42,000-42,500 MHz” in the table in paragraph (c) and by revising footnote 7 to read as follows:
(c) * * *
11. Section 101.113(a) is amended by removing the entry for “38,600-40,000 MHz” and by adding in numerical order entries in the table for “37,000-40,000 MHz” and for “42,000-42,500 MHz” to read as follows:
(a) * * *
12. Section 101.115 is amended by removing the entry for “38, 600-40,00 MHz”, adding in numerical order entries in the table for “37,000-40,000 MHz” and 42,000-42,500 MHz”, and by revising footnote 14 in paragraph (b) to read as follows:
(b) * * *
13. Section 101.147 is amended by revising paragraph (v) to read as follows:
(v)(1) Assignments in the bands 37,000-40,000 MHz and 42,000-42,500 MHz must be according to the following frequency plan:
(v)(2) Channel Blocks 1 through 37 are assigned for use within Economic Areas (EAs). Applicants are to apprise themselves of any licensed rectangular service areas in the band 38,6000-40,000 MHz within the EA for which they seek a license and comply with the requirements set out in § 101.103. All of the channel blocks may be subdivided as desired by the licensee as frequency pairs and used within its service area as desired without further authorization subject to the terms and conditions set out in § 101.149.
14. Section 101.149 is amended by revising introductory text and by adding paragraphs (d) and (e) to read as follows:
Assigned frequency channels in the bands 37,000-40,000 MHz, and 42,000-42,500 MHz may be aggregated/disaggregated with no limits and used anywhere in the authorized service area, subject to the following terms and conditions:
(d) Point-to-point, point-to-multipoint, fixed and mobile terrestrial operations (upon adoption of interference protection criteria for mobile operations) shall be permitted in the bands 37,000-40,000 MHz, and 42,000-42,500 MHz. Fixed satellite earth station operations may also be permitted if the license is obtained through competitive bidding, partitioning, and/or aggregation/disaggregation under part 101.
(e) For the frequency bands 37,000-40,000 MHz, and 42,000-42,500 MHz, spectrum must be aggregated/disaggregated by frequency pairs.
15. Subpart N of part 101 is amended by revising the subpart heading to read as follows:
16. Section 101.1201 is revised to read as follows:
Mutually exclusive initial applications for 37.0-40.0 GHz and 42.0-42.5 GHz band licenses are subject to competitive bidding. The general competitive bidding procedures set forth in 47 CFR part 1, subpart Q will apply unless otherwise provided in this subpart.
17. Subpart N is amended by adding § 101.1212 to read as follows:
(a)
(2) A very small business is an entity that, together with its affiliates, its controlling interests and the affiliates of its controlling interests, has average gross revenues that are not more than $15 million for the preceding three years.
(b)
(2) A winning bidder that qualifies as a very small business, as defined in this section, or a consortium of very small businesses may use a bidding credit of 25 percent, as specified in § 1.2110(f)(2)(ii), to lower the cost of its winning bid on any of the licenses in this part.
Grain Inspection, Packer and Stockyards Administration, USDA.
Notice.
The Grain Inspection, Packers and Stockyards Administration (GIPSA) is announcing its intent to provide official protein content measurements for wheat using an Artificial Neural Network (ANN) calibration on the official near-infrared transmittance (NIRT) instruments. GIPSA provides protein content measurement in wheat as official criteria under the authority of the United States Grain Standards Act.
Effective May 1, 2005.
Steven N. Tanner, Director, Technical Services Division, GIPSA, USDA, 10383 N. Ambassador Drive, Kansas City, Missouri 64153; telephone (816) 891-0401; fax (816) 891-0478.
At present, GIPSA maintains individual partial least squares (PLS) calibrations to determine protein content for each of the six major classes of wheat—Hard Red Winter, Soft Red Winter, Soft White, Hard Red Spring, Hard White, and Durum. As part of GIPSA's on-going efforts to evaluate calibrations and programs, GIPSA has thoroughly evaluated the effect of switching from the current PLS calibrations to an ANN calibration. A single ANN calibration can be used for protein determinations in all six wheat classes. Comprehensive results of GIPSA's evaluation and other ANN-related information may be found on GIPSA's Web site at:
Based on its evaluation, GIPSA has decided to implement the new ANN wheat protein calibration on official NIRT instruments for all classes of wheat on May 1, 2005.
7 U.S.C. 71
National Agricultural Statistics Service, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13) and Office of Management and Budget regulations at 5 CFR part 1320 (60 FR 44978, August 29, 1995), this notice announces the intent of the National Agricultural Statistics Service (NASS) to request revision of a currently approved information collection, the National Childhood Injury and Occupational Injury Survey of Farm Operators.
Comments on this notice must be received by November 1, 2004 to be assured of consideration.
Comments may be sent to Ginny McBride, NASS Clearance Officer, U.S. Department of Agriculture, Room 5330B South Building, 1400 Independence Avenue SW., Washington, DC 20250-2024 or
Carol House, Associate Administrator, National Agricultural Statistics Service, U.S. Department of Agriculture, (202) 720-4333.
These data will update and enhance existing data series used by the National Institute of Occupational Safety and Health to: (1) Establish a measure of the number and rate of childhood injuries associated with farming operations and study the specific types of injuries sustained and (2) describe the scope and magnitude of occupational injuries associated with farming operations. The collection combines the youth and occupational injury studies to reduce the number of contacts on the targeted farm population. Reports will be generated and information disseminated to all interested parties concerning the finding of this study.
These data will be collected under the authority of 7 U.S.C. 2204(a). Individually identifiable data collected under this authority are governed by Section 1770 of the Food Security Act of 1985, 7 U.S.C. 2276, which requires USDA to afford strict confidentiality to non-aggregated data provided by respondents.
Copies of this information collection and related instructions can be obtained without charge from Ginny McBride, Agency Clearance Officer, at (202) 720-5778.
All responses to this notice will become a matter of public record and be summarized in the request for OMB approval.
Committee for Purchase From People Who Are Blind or Severely Disabled.
Additions to and deletions from Procurement List.
This action adds to the Procurement List products and services to be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities, and deletes from the Procurement List products previously furnished by such agencies.
Effective September 26, 2004.
Committee for Purchase From People Who Are Blind or Severely Disabled, Jefferson Plaza 2, Suite 10800, 1421 Jefferson Davis Highway, Arlington, Virginia, 22202-3259.
Sheryl D. Kennerly, (703) 603-7740.
On June 4, June 18, and July 2, 2004, the Committee for Purchase From People Who Are Blind or Severely Disabled published notice (69 FR 31588, 34121, and 40350) of proposed additions to the Procurement List.
After consideration of the material presented to it concerning capability of qualified nonprofit agencies to provide the products and services and impact of the additions on the current or most recent contractors, the Committee has determined that the products and services listed below are suitable for procurement by the Federal Government under 41 U.S.C. 46-48c and 41 CFR 51-2.4.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organizations that will furnish the products and services to the Government.
2. The action will result in authorizing small entities to furnish the products and services to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 46-48c) in connection with the products and services proposed for addition to the Procurement List.
Accordingly, the following products and services are added to the Procurement List:
On April 30, 2004, the Committee for Purchase From People Who Are Blind or Severely Disabled published notice (69 FR 23723) of proposed deletions to the Procurement List. After consideration of the relevant matter presented, the Committee has determined that the products listed below are no longer suitable for procurement by the Federal Government under 41 U.S.C. 46-48c and 41 CFR 51-2.4.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action may result in additional reporting, recordkeeping or other compliance requirements for small entities.
2. The action may result in authorizing small entities to furnish the products to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 46-48c) in connection with the products deleted from the Procurement List.
Accordingly, the following products are deleted from the Procurement List:
DOC has submitted to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. chapter 35).
The Voting and Registration data yields statistics on voter (and nonvoter) characteristics and current voter trends. These data enable policymakers to keep issues up to date, such as changes in participation in the election process by demographic characteristics such as age, sex, race, ethnicity, and educational attainment.
This clearance will also cover an identical voting and registration supplement to be conducted in November 2006.
The primary purpose of collecting these data from the November 2004 CPS supplement is to relate demographic characteristics (age, sex, race, education, occupation, and income) to voting and nonvoting behavior. Federal, state, and local election officials; college institutions; political party committees; research groups; and other private organizations use the voting and registration data collected in the November 2004 CPS supplement. Election officials use these data to formulate policies relating to the voting and registration process. Data obtained on duration of residence will allow policymakers and researchers to better determine the relationships between other demographic characteristics and voting behavior. Previous studies have shown that the voting and registration characteristics of recent movers differ greatly from those of nonmovers. By collecting and presenting data at the state level, we will also obtain information on the effectiveness of increased voter registration drives in different regions.
Copies of the above information collection proposal can be obtained by calling or writing Diana Hynek, Departmental Paperwork Clearance Officer, (202) 482-0266, Department of Commerce, room 6625, 14th and Constitution Avenue, NW., Washington, DC 20230 (or via the Internet at
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to Susan Schechter, OMB Desk Officer either by fax (202-395-7245) or e-mail (
The Regulations and Procedures Technical Advisory Committee (RPTAC) will meet September 14, 2004, 9 a.m., Room 3884, in the Herbert C. Hoover Building, 14th Street between Constitution and Pennsylvania Avenues, NW., Washington, DC. The Committee advises the Office of the Assistant Secretary for Export Administration on implementation of the Export Administration Regulations (EAR) and provides for continuing review to update the EAR as needed.
1. Opening remarks by the Chairman.
2. Presentation of papers or comments by the public.
3. Update on Export Administration Regulations.
4. Update on computer and microprocessor technology controls.
5. Update on Special Intra-company License (SIL) proposal.
6. Update on encryption controls.
7. Update on country group revision project.
8. Update on Excluded Parties Listing System (EPLS) project.
9. Update on Automated Export System (AES).
10. Update on export enforcement initiatives.
11. Reports from working groups.
12. Discussion of matters determined to be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 sections 10(a)(1) and 10(a)(3).
A limited number of seats will be available for the public session. Reservations are not accepted. To the extent that time permits, members of the public may present oral statements to the Committee. The public may submit written statements at any time before or after the meeting. However, to facilitate the distribution of public presentation materials to the Committee members, the Committee suggests that presenters forward the public presentation materials prior to the meeting to Ms. Lee Ann Carpenter at
The Assistant Secretary for Administration, with the concurrence of the delegate of the General Counsel, formally determined on August 12, 2004, pursuant to Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. app. 2 section (10)(d)), that the portion of the meeting dealing with trade secrets and commercial or financial information deemed privileged or confidential as described in 5 U.S.C. section 552b(c)(4) and the portion of the meeting dealing with matters the disclosure of which would be likely to frustrate significantly implementation of an agency action as described in 5 U.S.C. 552b(c)(9)(B) shall be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 sections 10(a)(1) and 10(a)(3).
The remaining portions of the meeting will be open to the public. For more information, call Lee Ann Carpenter at (202) 482-2583.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meetings.
The Pacific Fishery Management Council (Council) and its advisory entities will hold public meetings.
The Council and its advisory entities will meet September 12-17, 2004. The Council meeting will begin on Tuesday, September 14, at 8 a.m., reconvening each day through Friday. All meetings are open to the public, except a closed session will be held from 8 a.m. to 9 a.m. on Tuesday, September 14 to address litigation and personnel matters. The Council will meet as late as necessary each day to complete its scheduled business.
The meetings will be held at the Hyatt Regency Islandia, 1441 Quivira Road, San Diego, CA 92109; telephone: 619-224-1234.
Dr. Donald O. McIsaac, Executive Director; telephone: (503) 820-2280.
The following items are on the Council agenda, but not necessarily in this order:
1. Opening Remarks, Introductions
2. Roll Call
3. Executive Director's Report
4. Approve Agenda
1. Approval of Council Meeting Minutes
2. NMFS Revision of National Standard 1
3. Update of Council Operating Procedures (COPs) and Statement of Organization, Practices, and Procedures (SOPPs) Documents
4. Council Communication Plan
5. Legislative Matters
6. Fiscal Matters
7. Interim Appointments to Advisory Bodies
8. Workload Priorities and Draft November 2004 Council Meeting Agenda
1. California Recreational Fishery Survey (CRFS) Program Review
2. Initial Consideration of Status of Fisheries and Inseason Adjustments
3. Consideration of Limited Refinements to the 2005/06 Fishery Management Specifications
4. Red Light/Green Light Threshold for Optimum Yield Adjustments
5. NMFS Report
6. Groundfish Essential Fish Habitat Environmental Impact Statement (EIS) - Preliminary Alternatives
7. Off-Year Science Improvements Report
8. Terms of Reference for Groundfish Rebuilding Plan Review
9. Final Consideration of 2004 Inseason Adjustments
10. Expansion of Vessel Monitoring System
11. Trawl Individual Quota EIS
1. Salmon Fishery Update
2. Salmon Methodology Review
3. Fishery Management Plan (FMP) Amendment Update
1. Guidelines for Review of Marine Reserves Issues
2. Update on Miscellaneous Marine Protected Areas Activities
3. Krill Harvest Ban Proposal
1. Pacific Halibut Fishery Update
2. Proposed Changes to the Catch Sharing Plan and Annual Regulations
3. Review of Pacific Halibut Bycatch Estimates for Use by the International Pacific Halibut Commission
Current Habitat Issues
1. NMFS Report
2. FMP Amendment for Limited Entry in the High Seas Pelagic Longline Fishery
3. Stock Assessments for Albacore and Blue Fin Tuna
1. NMFS Report
2. STAR Panel Report
3. FMP Amendment—Sardine Allocation
Although non-emergency issues not contained in this agenda may come before this Council for discussion, those issues may not be the subject of formal Council action during these meetings. Council 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 Council's intent to take final action to address the emergency.
These meetings are 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.
Committee for the Implementation of Textile Agreements (CITA).
Issuing a directive to the Commissioner, Bureau of Customs and Border Protection adjusting limits.
August 30, 2004.
Ross Arnold, International Trade Specialist, Office of Textiles and Apparel, U.S. Department of Commerce, (202) 482-4212. For information on the quota status of these limits, refer to the Quota Status Reports posted on the bulletin boards of each Customs port, call (202) 927-5850, or refer to the Bureau of Customs and Border Protection website at http://www.cbp.gov. For information on embargoes and quota re-openings, refer to the Office of Textiles and Apparel website at http://otexa.ita.doc.gov.
Section 204 of the Agricultural Act of 1956, as amended (7 U.S.C. 1854); Executive Order 11651 of March 3, 1972, as amended.
The current limits for certain categories are being increased for carryover.
A description of the textile and apparel categories in terms of HTS numbers is available in the CORRELATION: Textile and Apparel Categories with the Harmonized Tariff Schedule of the United States (see
Dear Commissioner: This directive amends, but does not cancel, the directive issued to you on October 14, 2003, by the Chairman, Committee for the Implementation of Textile Agreements. That directive concerns imports of certain cotton, wool, man-made fiber, silk blend and other vegetable fiber textiles and textile products, produced or manufactured in Taiwan and exported during the twelve-month period which began on January 1, 2004 and extends through December 31, 2004.
Effective on August 30, 2004, you are directed to increase the current limits for the following categories, as provided for under the Uruguay Round Agreement on Textiles and Clothing:
The Committee for the Implementation of Textile Agreements has determined that these actions fall within the foreign affairs exception of the rulemaking provisions of 5 U.S.C. 553(a)(1).
Sincerely,
Committee for the Implementation of Textile Agreements (CITA)
Issuing a directive to the Commissioner, Bureau of Customs and Border Protection amending visa requirements.
September 7, 2004.
Ross Arnold, International Trade Specialist, Office of Textiles and Apparel, U.S. Department of Commerce, (202) 482-4212.
Section 204 of the Agricultural Act of 1956, as amended (7 U.S.C. 1854); Executive Order 11651 of March 3, 1972, as amended.
In exchange of notes dated January 12, 2004 and August 4, 2004, the Governments of the United States and the Republic of Maldives agreed to amend the existing Visa Arrangement for cotton, wool, and man-made fiber apparel. The amended visa Arrangement establishes new provisions for the Electronic Visa Information System (ELVIS), but continues the requirement for the paper visa. This notice amends, but does not cancel, the notice and letter to the Commissioner of Customs, as amended, published in the Federal Register on August 24, 1982. (See 47 FR 36879.)
A description of the textile and apparel categories in terms of categories within the Harmonized Tariff Schedule of the United States is available in the CORRELATION: Textile and Apparel Categories with the Harmonized Tariff Schedule of the United States (see Federal Register notice 69 FR 4926, published on February 2, 2004).
Goods integrated into GATT 1994 in Stages II and III by the United States will not require a visa or ELVIS transmission (see Federal Register notices 63 FR 53881, published on October 7, 1998 and 66 FR 63225, published on December 5, 2001).
Interested persons are advised to take all necessary steps to ensure that textile products entered into the United States for consumption, or withdrawn from warehouse for consumption, will meet the visa requirements set forth in the letter published below to the Commissioner, Bureau of Customs and Border Protection.
Dear Commissioner: This directive amends, but does not cancel, the directive issued to you on August 18, 1982, as amended, by the Chairman, Committee for the Implementation of Textile Agreements. Under the terms of Section 204 of the Agricultural Act of 1956, as amended (7 U.S.C. 1854); pursuant to the Uruguay Round Agreement on Textiles and Clothing, and the exchange of notes on January 12, 2004 and August 4, 2004, between the Governments of the United States and the Republic of Maldives; and in accordance with the provisions of Executive Order 11651 of March 3, 1972, as amended, you are directed to prohibit entry into the customs territory of the United States (i.e. the 50 states, the District of Columbia and the Commonwealth of Puerto Rico) for consumption and withdrawal from warehouse for consumption of cotton, wool, and man-made fiber apparel, as detailed in the exchange of notes dated January 12, 2004 and August 4, 2004, and exported on or after September 7, 2004, for which the Government of the Republic of Maldives has not issued an appropriate export visa and Electronic Visa Information System (ELVIS) transmission fully described below. Should additional categories, part-categories or merged categories become subject to import quotas, the entire category(s), part-category(s) or merged category(s) shall be included in the coverage of this Arrangement. The categories covered by this directive are 237, 239, 330-359, 431-459, and 630-659. Integrated products do not require an ELVIS transmission or a visa.
A visa must accompany each shipment of the aforementioned textile products. The original visa in blue ink shall be stamped on the front of the original commercial invoice.
Each visa stamp will include the following information:
1. The visa number. The visa number shall be in the standard nine digit letter format beginning with one numeric digit for the last digit of the year of export, followed by the two character alpha code specified by the International Organization for Standardization (ISO) (The code for Maldives is MV), and a six digit numerical serial number identifying the shipment; e.g., 4MV123456.
2. The date of issuance. The date of issuance shall be the day, month, and year on which the visa was issued.
3. The original signature of the issuing official authorized by the Government of the Republic of Maldives.
4. The correct category(s), merged category(s), part category(s), quantity(s), and units of quantity in the shipment in the units(s) of quantity provided for in the U.S. Department of Commerce Correlation and in the Harmonized Tariff Schedule of the United States (HTSUS), e.g., “Cat. 340-510 DZ”.
Quantities must be stated in whole numbers. Decimals or fractions will not be accepted.
The Bureau of Customs and Border Protection shall not permit entry if the shipment does not have a visa, or if the visa number, date of issuance, signature, category, quantity are missing, incorrect, illegible, or have been crossed out or altered in any way. If the quantity indicated on the visa is less than that of the shipment, entry shall not be permitted. If the quantity indicated on the visa is more than that of the shipment, entry shall be permitted and only the amount entered shall be charged to any applicable quota.
Quantities shall be those determined by the Bureau of Customs and Border Protection.
If the visa is not acceptable then a new visa must be obtained from the Government of the Republic of Maldives or a visa waiver may be issued by the U.S. Department of Commerce at the request of the Government of the Republic of Maldives and presented to the Bureau of Customs and Border Protection before any portion of the shipment will be released. The waiver, if used, only waives the requirement to present a visa with the shipment. Visa waivers will only be issued for classification purposes or for one-time special purpose shipments that are not part of an ongoing commercial enterprise.
If the visaed invoice is deficient, the Bureau of Customs and Border Protection will not return the original document after entry, but will provide a certified copy of that visaed invoice for use in obtaining a new correct original visaed invoice, or a visa waiver.
Only the actual quantity in the shipment and the correct category will be charged to the restraint level.
A. Each ELVIS transmission shall include the following information:
i. The visa number: The visa number shall be in the standard nine digit letter format beginning with one numeric digit for the last digit of the year of export, followed by the two character alpha code specified by the International Organization for Standardization (ISO) (The code for Maldives is MV), and a six digit numerical serial number identifying the shipment; e.g., 4MV123456.
ii. The date of issuance: The date of issuance shall be the day, month and year on which the visa was issued.
iii. The correct category(s), merged category(s), part category(s), quantity(s), and unit(s) of quantity of the shipment in the unit(s) of quantity provided for in the U.S. Department of Commerce Correlation and in the Harmonized Tariff Schedule of the United States. Quantities must be stated in whole numbers. Decimals or fractions will not be accepted.
iv. The quantity of the shipment in the correct units of quantity
v. The manufacturer ID number (MID)
B. Entry of a shipment shall not be permitted:
I. if an ELVIS transmission has not been received for the shipment from the Government of the Republic of Maldives;
II.if the ELVIS transmission for that shipment is missing any of the following information:
i) visa number
ii) category, part category, or merged category
iii) quantity
iv) unit of measure
v) date of issuance
vi) manufacturer ID number
III. if the ELVIS transmission for the shipment does not match the information supplied by the importer, or the Customs broker acting as an agent on behalf of the importer, with regard to any of the following:
i) visa number
ii) category, part category, or merged category
iii) unit of measure
IV. If the quantity being entered is greater than the quantity transmitted.
V. If the visa number has previously been used, except in the case of a split shipment, or cancelled, except when entry has already been made using the visa number.
C. A new, correct ELVIS transmission from the Government of the Republic of Maldives is required before a shipment that has been denied entry for one the circumstances mentioned above will be released.
D. Visa waivers will only be accepted if the shipment qualifies for a one-time special purpose shipment that is not part of an ongoing commercial enterprise. A visa waiver may be issued by the Department of Commerce at the request of the Government of the Republic of Maldives. A visa waiver only waives the requirements to present an ELVIS transmission at the time of entry, and does not waive any quota requirements.
E. In the event of a systems failure, shipments will not be released for twenty-four hours or 1 calendar day. If system failure exceeds twenty-four hours or 1 calendar day, for the remaining period of the system failure the Bureau of Customs and Border Protection will release shipments on the basis of the visa data provided by the Government of the Republic of Maldives. The Republic of Maldives will retransmit all data that was affected by the systems failure when the system is functioning normally.
Merchandise imported for the personal use of the importer and not for resale, regardless of value, and properly marked commercial sample shipments valued at U.S. $800 or less do not require a visa or an ELVIS transmission for entry and shall not be charged to Agreement levels.
The visa stamp remains unchanged.
Goods integrated into GATT 1994 in Stages II and III by the United States will not require a visa or ELVIS transmission (see Federal Register notices 63 FR 53881, published on October 7, 1998 and 66 FR 63225, published on December 5, 2001, respectively). A visa and ELVIS transmission will continue to be required for non-integrated products.
The Committee for the Implementation of Textile Agreements has determined that this action fall with the foreign affairs exception to the rulemaking provisions of 5 U.S.C. 553(a)(1).
Sincerely,
Office of Special Education and Rehabilitative Services, Department of Education.
Notice of proposed priorities for knowledge dissemination and utilization projects.
The Assistant Secretary for Special Education and Rehabilitative Services proposes priorities for three knowledge dissemination and utilization projects under the National Institute on Disability and Rehabilitation Research (NIDRR) Disability and Rehabilitation Research Projects (DRRP) Program. The Assistant Secretary may use these priorities for competitions in fiscal year (FY) 2005 and later years. We take this action to focus attention on an identified national need. We intend these priorities to improve rehabilitation outcomes for individuals with disabilities.
We must receive your comments on or before September 27, 2004.
Address all comments about this proposed priority to Donna Nangle, U.S. Department of Education, 400 Maryland Avenue, SW., Room 6030, Potomac Center Plaza, Washington, DC 20202-2600. If you prefer to send your comments through the Internet, use the following address:
Donna Nangle. Telephone: (202) 245-7462.
If you use a telecommunications device for the deaf (TDD), you may call the the Federal Information Relay Service (FIRS) at 1-800-877-8339 or via Internet:
Individuals with disabilities may obtain this document in an alternative format (
We invite you to submit comments regarding these proposed priorities. To ensure that your comments have maximum effect in developing the notice of final priorities, we urge you to identify clearly the specific proposed priority or topic that each comment addresses.
We invite you to assist us in complying with the specific requirements of Executive Order 12866 and its overall requirement of reducing regulatory burden that might result from these proposed priorities. Please let us know of any further opportunities we should take to reduce potential costs or increase potential benefits while preserving the effective and efficient administration of the program.
During and after the comment period, you may inspect all public comments about these priorities in Room 6032, 550 12th Street, SW., Potomac Center Plaza, Washington, DC, between the hours of 8:30 a.m. and 4 p.m., eastern time, Monday through Friday of each week except Federal holidays.
On request, we will supply an appropriate aid, such as a reader or print magnifier, to an individual with a disability who needs assistance to review the comments or other documents in the public rulemaking record for these proposed priorities. If you want to schedule an appointment for this type of aid, please contact the
We will announce the final priorities in a notice in the
These proposed priorities are in concert with NIDRR's 1999-2003 Long-Range Plan (Plan). The Plan is comprehensive and integrates many issues relating to disability and rehabilitation research topics. While applicants will find many sections throughout the Plan that support the activities to be conducted under these proposed priorities, specific references are included for the topics presented in this notice. The Plan can be accessed on the Internet at the following site:
Through the implementation of the Plan, NIDRR seeks to: (1) Improve the quality and utility of disability and rehabilitation research; (2) foster an exchange of expertise, information, and training to facilitate the advancement of knowledge and understanding of the unique needs of traditionally underserved populations; (3) determine best strategies and programs to improve rehabilitation outcomes for underserved populations; (4) identify research gaps; (5) identify mechanisms of integrating research and practice; and (6) disseminate findings.
The purpose of the DRRP Program is to plan and conduct research, demonstration projects, training, and related activities that help to maximize the full inclusion and integration of individuals with disabilities into society and to improve the effectiveness of services authorized under the Rehabilitation Act of 1973, as amended (Act).
Under the DRRP program, we define a development activity as using knowledge and understanding gained from research to create materials, devices, systems, or methods beneficial to the target population, including design and development of prototypes and processes. We define a dissemination activity as the systematic distribution of information or knowledge through a variety of ways to potential users or beneficiaries. We define a technical assistance activity as the provision of expertise or information for use in problem-solving.
Knowledge Dissemination and Utilization (KDU) projects ensure widespread distribution, in usable formats, of practical scientific and technological information generated by research, development, and demonstration projects. The effective dissemination and utilization of disability and rehabilitation research results are critical to achieving NIDRR's mission. Research findings can improve the quality of life of people with disabilities and further their full inclusion into society. These benefits are feasible only if the findings and technologies are available to, known by, and accessible to potential users.
NIDRR is particularly interested in ensuring that information to be disseminated is of high quality and is based on scientifically rigorous research and development and that potential users have the information they need to judge the quality of research and development findings and products and the relevance of these findings and products to their particular needs. End-users with limited scientific training, in particular, may need assistance in order to understand competing research claims or determine the relevance of particular findings to their individual situations. In addition, given the nature of scientific study, practical information often is based on cumulative knowledge, not upon the results of any one study. Therefore, we encourage potential applicants to examine procedures used by such organizations as the Campbell Collaboration (
The Assistant Secretary for Special Education and Rehabilitative Services proposes to fund up to three DRRPs to develop dissemination methods and provide technical assistance that focus on innovative knowledge sharing solutions to improve the lives of persons with disabilities. The goal of the projects is to provide end-users with the information they need to make choices based on high-quality scientific research and development. Under each of these topics, the KDU project must:
(1) Identify topic areas and target audiences, which must include people with disabilities and their families;
(2) Develop standards to guide the systematic review and synthesis of disability and rehabilitation research and development studies;
(3) Identify or develop effective outreach strategies for the target audiences;
(4) Develop research syntheses in selected topic areas and make this information available, in preferred formats, to the target audiences; and
(5) Develop cost-effective outreach strategies to provide target audiences with research-based information, and determine whether and how the information is used.
In carrying out these project requirements, in consultation with the NIDRR project officer, each project must:
• Involve, as appropriate, individuals with disabilities or their family members, or both, in all aspects of the design and development of dissemination activities;
• Demonstrate how the project will yield measurable results for people with disabilities; and
• Identify specific performance targets and propose outcome indicators, along with timelines to reach these targets.
A project must focus on one of the following priority topic areas:
(a)
The reference to this topic may be found in the Plan, Chapter 8, Knowledge Dissemination and Utilization, and Chapter 10, Enhancing NIDRR's Management of Research.
(b)
• Develop innovative methods for compiling and exchanging information between the United States and other nations on rehabilitation research and development, as well as information on disability policies that maximize the full inclusion, social integration, employment, and independent living of individuals of all ages with disabilities.
• Provide targeted outreach to and obtain insight from researchers; consumers; and voluntary, non-profit, and philanthropic organizations that are operating programs related to disability and rehabilitation research in other nations.
• Conduct at least one rehabilitation research information conference per funding cycle involving participants from the United States and other countries to provide state-of-the-art information on international rehabilitation research efforts and policies that affect people with disabilities.
• Conduct an international exchange of researchers and technical assistance experts between other countries and the United States to provide firsthand experiences in cross-cultural communication and to form alliances for collaborative research or information sharing.
The reference to this topic may be found in the Plan, Chapter 10, Enhancing NIDRR's Management of Research.
(c)
The reference to this topic may be found in the Plan, Chapter 8, Knowledge Dissemination and Utilization, and Chapter 10, Enhancing NIDRR's Management of Research.
This notice of proposed priorities has been reviewed in accordance with Executive Order 12866. Under the terms of the order, we have assessed the potential costs and benefits of this regulatory action.
The potential costs associated with the notice of proposed priorities are those resulting from statutory requirements and those we have determined as necessary for administering this program effectively and efficiently.
In assessing the potential costs and benefits—both quantitative and qualitative—of this notice of proposed priorities, we have determined that the benefits of the proposed priorities justify the costs.
The potential costs associated with these proposed priorities are minimal, while the benefits are significant. Grantees may anticipate costs associated with completing the application process in terms of staff time, copying, and mailing or delivery. The use of e-Application technology reduces mailing and copying costs significantly.
The benefits of the DRRP Program have been well established over the years. Similar projects have been completed successfully and have produced findings that help improve the lives of individuals with disabilities. These proposed priority will generate new strategies for disseminating findings from disability and rehabilitation research and development that will improve the full integration of individuals with disabilities into society.
You may view this document, as well as all other Department of Education documents published in the
Election Assistance Commission (EAC).
Notice of Request for Applications—Federal Grant Opportunity.
Pursuant to Sections 501-503 of the Help America Vote Act (HAVA), Public Law 107-252, the U.S. Election Assistance Commission (EAC or Commission) is hereby publishing in the
This notice is effective upon publication in the
Phone: Karen Lynn-Dyson at (202) 566-3100 or 1-866-747-1471 (toll-free).
This announcement is covered under the Help America Vote Act of 2002, Public Law (Pub. L.) 107-252, Title V. Provisions under this title allow the U.S. Election Assistance Commission to award grants for the development of a program to encourage students enrolled at institutions of higher education (including community colleges) to assist State and local governments in the administration of elections by serving as nonpartisan poll workers or assistants.
Project funds must be used for projects and activities which are carried out without partisan bias or without promoting any particular point of view regarding any issue.
The U.S. Election Assistance Commission (“EAC” or “Commission”) was established by the Help America Vote Act of 2002 (“HAVA”). Central to its role, the Commission serves as a national clearinghouse and resource for information and review of procedures with respect to the administration of federal elections.
• Generate technical guidance on the administration of federal elections.
• Produce voluntary voting systems guidelines.
• Research and report on matters that affect the administration of federal elections.
• Otherwise provide information and guidance with respect to laws, procedures, and technologies affecting the administration of federal elections.
• Administer payments to States to meet HAVA requirements.
• Provide grants for election technology development and for pilot programs to test election technology.
• Develop a national program for the testing, certification, and decertification of voting systems.
• Maintain the national mail voter registration form that was developed in accordance with the National Voter Registration Act of 1993 (“NVRA”), report to Congress every two years on the impact of the NVRA on the administration of federal elections, and provide information to States on their responsibilities under that law.
• Audit entities who receive federal funds authorized by HAVA from the General Services Administration or the EAC.
• Submit an annual report to Congress describing EAC activities for the previous fiscal year.
Additionally, the EAC is required, not later than one year after the appointment of its members, to develop a program to be known as the “Help America Vote College Program.”
The EAC is seeking proposals which will assist the Commission in developing and implementing the Help America Vote College Program (“College Program”).
The purpose of the College Program is to encourage students enrolled at institutions of higher education (including community colleges) to assist state and local governments in the administration of elections by serving as nonpartisan poll workers or assistants, and to encourage state and local governments to use the services of the students participating in the College Program.
While laws regarding eligibility for poll worker service vary somewhat from state to state, in all states, poll worker service requires dedication. Poll workers are required to attend a training session conducted by the local election jurisdiction prior to Election Day. Most training sessions occur in the month prior to Election Day (
Applicants also should be aware that poll workers generally are required to be at polling locations to help set up prior to the opening of polls, and should plan to stay at least 45 minutes after the close of polls on Election Day. In some jurisdictions options to split a shift are available. Applicants should understand that college poll workers may be required to remain at the polling location the entire day on Election Day. It should be noted that poll workers are paid a stipend both for attending training and for their service on Election Day. The stipend amounts, paid by the election jurisdiction, vary widely.
Applicants should be aware that most states require that poll workers be registered voters in the state in which they serve. Other states require that poll workers be registered voters in the county in which they serve. In some cases, however, students are exempt from these requirements and may serve under various titles such as assistants or interpreters.
In making grants under the College Program, the EAC requires that the funds provided are spent for projects and activities which are carried out without partisan bias or without promoting any particular point of view regarding any issue, and that each grant recipient is governed in a balanced manner which does not reflect any partisan bias.
Applicants should be informed that the EAC will require all grant recipients to submit a final written report discussing outcomes and/or related qualitative data, which the EAC will use to develop recommendations to the U.S. Congress, States and local governments about future involvement of college students as poll workers and/or “best practices” information.
• Outline a plan of action which describes the scope and detail of how the proposed work will be accomplished, given the description and purpose detailed above regarding the College Program;
• Describe any unusual features of the project such as design or technological
• Provide quantitative projections of the accomplishments to be achieved for each function or activity in such terms as the number of college students expected to participate and the number of activities accomplished. When accomplishments cannot be quantified by activity or function, list them in chronological order to show the schedule of accomplishments and their target dates.
• Identify the results and benefits to be derived. For example, describe how the activities that your organization undertakes will promote the participation of college students to work as poll workers or assistants during the upcoming November 2nd general election.
• To the extent possible, include information on meeting the poll worker eligibility requirements for the jurisdiction(s) covered by the student population described in the application;
• To the extent possible, include information showing current involvement and/or support from the local election administrator(s) of the jurisdiction(s) covered by the student population described in the application or ways in which such involvement and/or support will be developed during the project period;
• Describe for all functions or activities identified in the application and, if applicable, cite factors which might accelerate or decelerate the work and state your reason for taking the proposed approach rather than others;
• Present a budget with reasonable project costs, appropriately allocated across component areas, and sufficient to accomplish the objectives, such as documentation of the dollar amount requested, as well as a description of the fiscal controls and accounting procedures that will be used to ensure prudent use, proper disbursement, and accurate accounting of funds received under this program announcement.
State controlled institutions of higher education; private institutions of higher education; community colleges; non-profit organizations, other than institutions of higher education; and faith-based organizations.
All applications that are developed jointly by more than one agency or organization must identify only one organization as the lead organization and the official applicant. The other participating organizations can be included as co-participants, sub-grantees, or subcontractors.
Any non-profit organization submitting an application must include proof of its non-profit status in its application at the time of submission. The non-profit organization can accomplish this by providing any one of the following:
(a) A reference to the applicant organization's listing in the Internal Revenue Service's (IRS) most recent list of tax-exempt organizations described in the IRS code.
(b) A copy of a currently valid IRS tax exemption certificate.
(c) A statement from a State taxing body, State Attorney General, or other appropriate State official certifying that the applicant organization has a non-profit status and that none of the net earnings accrue to any private shareholders or individuals.
(d) A certified copy of the organization's certificate of incorporation or similar document that clearly establishes non-profit status.
(e) Any of the items in the subparagraphs immediately above for a State or national parent organization and a statement signed by the parent organization that the applicant organization is a local non-profit affiliate.
Applicants are cautioned that the ceiling for individual awards is $150,000. Requests that exceed the $150,000 threshold will be considered non-responsive and will not be eligible for funding under this announcement.
Applications that are developed jointly by more than one agency or organization that fail to identify only one organization as the lead organization and the official applicant will be considered non-responsive and returned without review.
Pre-award costs are not allowable charges to this program. Applications that include pre-award costs with their submission will be considered non-responsive and will not be eligible for funding under this announcement.
Construction is not an allowable activity or expenditure under this program. Applications that propose construction projects or expenditures will be considered non-responsive and will not be eligible for funding under this announcement.
None.
On June 27, 2003, the Office of Management and Budget published in the
Please ensure that your organization has a DUNS number. You may acquire a DUNS number at no cost by calling the dedicated toll-free DUNS number request line on 1-866-705-5711 or you may request a number on-line at
Applicants are cautioned that the ceiling for individual awards is $150,000. Requests that exceed the $150,000 threshold will be considered non-responsive and will not be eligible for funding under this announcement.
Applications that are developed jointly by more than one agency or organization that fail to identify only one organization as the lead organization and the official applicant will be considered non-responsive and returned without review.
Pre-award costs are not allowable charges to this program. Applications that include pre-award costs with their submission will be considered non-responsive and will not be eligible for funding under this announcement.
Construction is not an allowable activity or expenditure under this program. Applications that propose construction projects or expenditures will be considered non-responsive and will not be eligible for funding under this announcement.
U.S. Election Assistance Commission, 1225 New York Avenue, NW., Suite 1100, Washington, DC 20005, Attention: Karen Lynn-Dyson, Phone: (202) 566-3100; Fax: (202) 566-1389.
Application forms and certifications may also be downloaded from the “Help America Vote College Program” link at the following Internet address:
Each application package must include an original and two copies of the complete application. Each copy should be stapled securely (front and back if necessary) in the upper left-hand corner. All pages of the project description/narrative must be sequentially numbered, beginning with page one. In order to facilitate handling, please do not use covers, binders or tabs. Do not include extraneous materials as attachments, such as agency promotion brochures, slides, tapes, film clips, minutes of meetings, survey instruments or entire articles of incorporation.
You may view this grant announcement via
U.S. Election Assistance Commission, 1225 New York Avenue, NW., Suite 1100, Washington, DC 20005, Attention: Karen Lynn-Dyson, Program Director. Any questions regarding this announcement can be directed to Karen Lynn-Dyson at (202) 566-3100 or by e-mail at
Please note that to use grants.gov, you, as the applicant, must have a DUNS Number. You may acquire a DUNS number at no cost by calling the dedicated toll-free DUNS number request line on 1-866-705-5711 or you may request a number on-line at
A complete application consists of the following items:
The above forms and certifications may be found at the “Help America Vote College Program” link located at
Private, non-profit organizations are encouraged to submit with their applications the survey located under “Grant Related Documents and Forms” titled “Survey for Private, Non-Profit Grant Applicants.” The forms are located on the Web at
The EAC requires that applications for this grant announcement be submitted—not later than September 9, 2004—in paper format only by mailing or hand delivering a hard copy of the application, as instructed below. All applications will be evaluated upon receipt and initial screening.
Applications hand carried by applicants, applicant couriers, other representatives of the applicant, or by overnight/express mail couriers shall be considered as meeting an announced deadline if they are received on or before the deadline date, between the hours of 8 a.m. and 5 p.m., e.s.t., at the following address: U.S. Election Assistance Commission, 1225 New York Avenue, NW., Suite 1100, Washington, DC 20005, Attention: Karen Lynn-Dyson, Program Director, Help America Vote College Program.
The closing time and date for receipt of applications is 5 p.m. (Eastern Standard Time) on Thursday, September 9, 2004. Mailed or hand carried applications received after 5 p.m. e.s.t. on the closing date will be classified as late.
State Single Point of Contact (SPOC):
This program is covered under Executive Order 12372, “Intergovernmental Review of Federal Programs.” Under the Order, States may design their own processes for reviewing and commenting on proposed Federal assistance under covered programs. As of October 1, 2003, the following jurisdictions have elected to participate in the Executive Order process:
Arkansas, California, Delaware, Florida, Georgia, Illinois, Iowa, Kentucky, Maine, Maryland, Michigan, Mississippi, Missouri, Nevada, New Hampshire, New Mexico, New York, North Dakota, Rhode Island, South Carolina, Texas, Utah, West Virginia, Wisconsin, District of Columbia, Puerto Rico, American Somoa, Guam, North Mariana Islands, and the Virgin Islands.
Applicants from these jurisdictions should determine the SPOC for that jurisdiction, and contact their SPOC as soon as possible to alert them of the prospective application and receive instructions. Applicants must submit any required material to the SPOC as soon as possible so that the program office can obtain and review SPOC comments as part of the award process. The applicant must submit all required materials, if any, to the SPOC and indicate the date of this submittal (or the date of contact if no submittal is required) on the Standard Form 424, item 16a. Under 45 CFR 100.8(a)(2), a SPOC has up to 60 days from the application deadline to comment on proposed new or competing continuation awards.
Applicants from a jurisdiction that does not participate in the Executive Order process, and which have met the eligibility requirements of this program, are still eligible to apply for a grant even
A list of the Single Points of Contact for each State and Territory can be obtained from the following Web site:
Applicants are cautioned that the ceiling for individual awards is $150,000.
Applications exceeding the $150,000 threshold will be considered non-responsive and will not be eligible for funding under this announcement.
Pre-award costs are not allowable charges to this program. Applications that include pre-award costs with their submission will be considered non-responsive and will not be eligible for funding under this announcement.
Construction is not an allowable activity or expenditure under this program. Applications that propose construction projects or expenditures will be considered non-responsive and will not be eligible for funding under this announcement.
Submission by Mail: An applicant must provide an original application with all attachments, signed by an authorized representative and two copies. The Application must be received at the address below by 5 p.m. Eastern Standard Time on or before the closing date, which is Thursday, September 9, 2004. Applications should be mailed to: U.S. Election Assistance Commission, 1225 New York Avenue, NW., Suite 1100, Washington, DC 20005, Attention: Karen Lynn-Dyson, Program Director, Help America Vote College Program.
Hand Delivery: An applicant must provide an original application with all attachments signed by an authorized representative and two copies. The application must be received at the address below by 5 p.m. Eastern Standard Time on or before the closing date, which is Thursday, September 8, 2004. Applications that are hand delivered will be accepted between the hours of 8 a.m. to 5 p.m., Monday through Friday. Applications may be delivered to: U.S. Election Assistance Commission, 1225 New York Avenue, NW., Suite 1100, Washington, DC 20005, Attention: Karen Lynn-Dyson, Program Director, Help America Vote College Program.
The SF 424, SF 424A, SF 424A—Page 2 and Certifications/Assurances are contained in the application package that can be accessed as mentioned earlier in this announcement. Please prepare your application in accordance with the following instructions:
Please read the following instructions before completing the application cover sheet. An explanation of each item is included. Complete only the items specified.
Top of Page. Please indicate that you are applying for new or implementation funds.
Item 1. “Type of Submission”—Preprinted on the form.
Item 2. “Date Submitted” and “Applicant Identifier”—Date application is submitted to EAC and applicant's own internal control number, if applicable.
Item 3. “Date Received By State”—State use only (if applicable).
Item 4. “Date Received by Federal Agency”—Leave blank.
Item 5. “Applicant Information.”
“Legal Name”—Enter the legal name of applicant organization. For applications developed jointly, enter the name of the lead organization only. There must be a single applicant for each application.
“Organizational Unit”—Enter the name of the primary unit within the applicant's organization that will actually carry out the project activity. Do not use the name of an individual as the applicant. If this is the same as the applicant organization, leave the organizational unit blank.
“Address”—Enter the complete address that the organization actually uses to receive mail, since this is the address to which all correspondence will be sent. Do not include both street address and P.O. Box number unless both must be used in mailing.
“Name and telephone number of the person to be contacted on matters involving this application (give area code)”—Enter the full name and telephone number of a person who can respond to questions about the application. This person should be accessible at the address given here and will receive all correspondence regarding the application.
Item 6. “Employer Identification Number (EIN)”—Enter the employer identification number of the applicant organization, as assigned by the Internal Revenue Service.
Item 7. “Type of Applicant”— Self-explanatory (
Item 8. “Type of Application”—Preprinted on the form.
Item 9. “Name of Federal Agency”—Preprinted on the form.
Item 10. “Catalog of Federal Domestic Assistance Number and Title”—Enter the Catalog of Federal Domestic Assistance (CFDA) number assigned to the program under which assistance is requested and its title.
Item 11. “Descriptive Title of Applicant's Project”—Enter the project title. The title is generally short and is descriptive of the project, not the priority area title.
Item 12. “Areas Affected by Project”—Enter the governmental unit where significant and meaningful impact could be observed. List only the largest unit or units affected, such as State, county, or city. If an entire unit is affected, list it rather than subunits.
Item 13. “Proposed Project”—Enter the desired start date for the project and projected completion date.
Item 14. “Congressional District of Applicant/Project”—Enter the number of the Congressional district where the applicant's principal office is located and the number of the Congressional district(s) where the project will be located. If Statewide, a multi-State effort, or nationwide, enter “00.”
Item 15. Estimated Funding Levels. In completing 15a through 15f, the dollar amounts entered should reflect, for a 3-4 month project period, the total amount requested.
Item 15a. Enter the amount of Federal funds requested in accordance with the preceding paragraph. This amount should be no greater than the maximum amount specified in the priority area description.
Items 15b-e. Not Applicable.
Item 15f. Enter the estimated amount of program income, if any, expected to be generated from the proposed project. Do not add or subtract this amount from the total project amount entered under item 15g. Describe the nature, source and anticipated use of this program income in the Project Narrative Statement.
Item 15g. Enter the sum of items 15a-15e.
Item 16a. “Is Application Subject to Review By State Executive Order 12372 Process? Yes.”—Enter the date the applicant contacted the SPOC regarding this application. Select the appropriate
Item 16b. “Is Application Subject to Review By State Executive Order 12372 Process? No.”—Check the appropriate box if the application is not covered by E.O. 12372 or if the program has not been selected by the State for review.
Item 17. “Is the Applicant Delinquent on any Federal Debt?”— Check the appropriate box. This question applies to the applicant organization, not the person who signs as the authorized representative. Categories of debt include audit disallowances, loans and taxes.
Item 18. “To the best of my knowledge and belief, all data in this application/pre-application are true and correct. The document has been duly authorized by the governing body of the applicant and the applicant will comply with the attached assurances if the assistance is awarded.”—To be signed by the authorized representative of the applicant. A copy of the governing body's authorization for signature of this application by this individual as the official representative must be on file in the applicant's office, and may be requested from the applicant.
Item 18a-c. “Typed Name of Authorized Representative, Title, Telephone Number”—Enter the name, title and telephone number of the authorized representative of the applicant organization.
Item 18d. “Signature of Authorized Representative” —Signature of the authorized representative named in Item 18a. At least one copy of the application must have an original signature. Use colored ink (not black) so that the original signature is easily identified.
Item 18e. “Date Signed”—Enter the date the application was signed by the authorized representative.
This is a form used by many Federal agencies. For this application, Sections A, B, and F are to be completed. Sections C, D and E do not need to be completed.
Sections A and B should include the Federal as well as the non-Federal funding for the proposed project covering the total project period of 4 months or less.
A separate budget justification should be included to fully explain and justify major items, as indicated below. The types of information to be included in the justification are indicated under each category. The budget justification should immediately follow the second page of the SF 424A.
Personnel—Line 6a. Enter the total costs of salaries and wages of applicant/grantee staff for the project period. Do not include the costs of consultants; this should be included on line 6h, “Other.”
Justification: Identify the principal investigator or project director, if known. Specify by title or name the percentage of time allocated to the project, the individual's project period salary, and the cost to the project of the organization's staff who will be working on the project.
Fringe Benefits—Line 6b. Enter the total costs of fringe benefits, unless treated as part of an approved indirect cost rate.
Justification: Provide a break-down of amounts and percentages that comprise fringe benefit costs, such as health insurance, FICA, retirement insurance,
Travel—6c. Enter total costs of out-of-town travel (travel requiring per diem) for staff of the project. Do not enter costs for consultant's travel or local transportation, which should be included on Line 6h, “Other.”
Justification: Include the name(s) of traveler(s), total number of trips, destinations, length of stay, transportation costs and subsistence allowances.
Equipment—Line 6d. Enter the total costs of all equipment to be acquired by the project.
Justification: Equipment to be purchased with Federal funds must be justified. The equipment must be required to conduct the project, and the applicant organization or its sub grantees must not have the equipment or a reasonable facsimile available to the project. The justification also must contain plans for future use or disposal of the equipment after the project ends.
Supplies—Line 6e. Enter the total costs of all tangible expendable personal property (supplies) other than those included on Line 6d.
Justification: Specify general categories of supplies and their costs.
Contractual—Line 6f. Enter the total costs of all contracts, including (1) Procurement contracts (except those which belong on other lines such as equipment, supplies,
Justification: Attach a list of contractors, indicating the names of the organizations, the purposes of the contracts, and the estimated dollar amounts of the awards as part of the budget justification. Whenever the applicant/grantee intends to delegate part or the entire program to another agency, the applicant/grantee must complete this section (Section B, Budget Categories) for each delegate agency by agency title, along with the supporting information. The total cost of all such agencies will be part of the amount shown on Line 6f. Provide backup documentation identifying the name of contractor, purpose of contract, and major cost elements.
Construction—Line 6g. Not applicable. New construction is not allowable.
Other—Line 6h. Enter the total of all other costs. Where applicable, such costs may include, but are not limited to: Insurance; medical and dental costs; non-contractual fees and travel paid directly to individual consultants; local transportation (all travel which does not require per diem is considered local travel); space and equipment rentals; printing and publication; computer use; training costs, including tuition and stipends; training service costs, including wage payments to individuals and supportive service payments; and staff development costs. Note that costs identified as “miscellaneous” and “honoraria” are not allowable.
Justification: Specify the costs included.
Total Direct Charges—Line 6i. Enter the total of Lines 6a through 6h.
Indirect Charges—6j. Enter the total amount of indirect charges (costs). If no indirect costs are requested, enter “none.” Generally, this line should be used when the applicant (except local governments) has a current indirect cost
Justification: Enclose a copy of the indirect cost rate agreement.
Applicants subject to the limitation on the Federal reimbursement of indirect costs for training grants should specify this.
Total—Line 6k. Enter the total amounts of lines 6i and 6j.
Program Income—Line 7. Enter the estimated amount of income, if any, expected to be generated from this project. Do not add or subtract this amount from the total project amount.
Justification: Describe the nature, source, and anticipated use of program income in the Program Narrative Statement.
Direct Charges—Line 21. See Form Instructions.
Indirect Charges—Line 22. Enter the type of indirect rate (provisional, predetermined, final or fixed) that will be in effect during the funding period, the estimated amount of the base to which the rate is applied, and the total indirect expense.
In considering how applicants will carry out the responsibilities addressed under this announcement, competing applications for financial assistance will be reviewed and evaluated against the following criteria:
Applicants will be evaluated based on the extent to which they present a plan that (1) clearly reflects an understanding of the characteristics of the targeted population (college students) and methods for successfully motivating such students to participate as poll workers or other election administration assistants on Election Day; (2) provides appropriate services that directly address the goals of this program; (3) provides services that are appropriate and feasible; and (4) can be reliably evaluated.
• Applications will be evaluated based on the extent to which they outline a plan of action pertaining to the scope and detail on how the proposed work will be accomplished for each project, and include a definition of the goals and specific measurable objectives for the project (15 points);
• Applications will be evaluated based on the extent to which they describe any unusual features of the project, such as design or technological innovation, reductions in cost or time, or extraordinary social and community involvement (10 points);
• Applications will be evaluated based on the extent to which they describe the products to be developed during the implementation of the proposed project, such as brochures and promotional materials, data collection instruments, internet applications, reports, evaluation results, and a dissemination plan for conveying the information (5 points);
• Applications will be evaluated based on the extent to which they cite factors which might accelerate or decelerate the work and provide reasons for taking this approach as opposed to others (5 points);
• Applications will be evaluated based on the extent to which they include information on meeting the poll worker eligibility requirements for the jurisdiction(s) covered by the student population described in the application (2.5 points);
• Applications will be evaluated based on the extent to which they show current involvement and/or support from the local election administrator(s) and other key stakeholders of the jurisdiction(s) covered by the student population described in the application or ways in which such involvement and/or support will be developed during the proposed project period (2.5 points).
Applications will be evaluated based on the extent to which they discuss the criteria to be used to evaluate the results, explain the methodology that will be used to determine if the needs identified and discussed are being met, and the results and benefits identified are being achieved.
• Applications will be evaluated based on the extent to which they identify the kinds of data to be collected and maintained and discuss the criteria to be used to evaluate the results and success of the project. For example, the applicant may provide a description of how the proposed project will be evaluated to determine the extent to which it has achieved its stated goals and objectives; the applicant may also provide a description of methods of evaluation that include the use of performance measures that are clearly related to the intended outcome of the project; (15 points).
• Applications will be evaluated based on the extent to which they provide for each project, when possible, a quantitative description of the accomplishments to be achieved and, when quantification is not possible, a list of activities, in chronological order, to show the schedule of accomplishments and their target date; (10 points).
• Applications will be evaluated based on the extent to which they provide information regarding how the project will build on current research, evaluation and/or best practices to contribute to increased knowledge and understanding of the problems, issues, or effective strategies and practices as they relate to college students participating as poll workers or other election administration assistants; (5 points).
Applications will be evaluated based on the extent to which they identify how the applicant organization (or the unit within the organization that will have responsibility for the project) is structured, the types and quantity of services, and the management capabilities it possesses. Applications will be evaluated based on the extent to which the applicant demonstrates a capacity to implement the proposed project including (1) Experience with similar projects; (2) experience with the target population; (3) qualifications and experience of the project leadership; (4) experience and commitment of any proposed consultants and subcontractors; and (5) appropriateness of the organizational structure, including its management information system, to carry out the project.
• Application will be evaluated based on the extent to which they demonstrate experience with similar projects and the target population (10 points);
• Application will be evaluated based on the extent to which they identify the background of the project director and key project staff (such as the inclusion of name, address, and training, educational background and other qualifying experience) and the extent to which they demonstrate that the experience of the organization is such that the applicant may effectively and efficiently administer this project and produce a usable final product. For example, this can include providing brief resumes of key project staff (10 points);
• Applications will be evaluated based on the extent to which they provide a brief background description of how the applicant organization is organized (such as an organizational chart that illustrates the relationship of the project to the current organization) the types and quantity of services it provides, and the research and management capabilities it possesses (5 points).
Applications will be evaluated based on the extent to which the applicant presents a budget with reasonable project costs, appropriately allocated across component areas, and sufficient to accomplish the objectives, such as the inclusion of a justification for and documentation of the dollar amount requested.
(1) Applications will be evaluated based upon the extent to which they include a narrative budget justification that describes how the categorical costs are derived and a discussion of the reasonableness and appropriateness of the proposed costs. Line item allocations and justifications are required for Federal funds.
All necessary salary information must appear on the signed original application for the EAC. Applicants, however, have the option of omitting the Social Security Numbers and specific salary rates of the proposed project personnel from the two copies submitted with the original applications to EAC. For purposes of the outside review process, applicants may elect to summarize salary information on the copies of their application.
• Applications will be evaluated based on the extent to which they discuss and justify the costs of the proposed project as being reasonable and programmatically justified in view of the activities to be conducted and the anticipated results and benefits (5 points) and;
• Applications will be evaluated based on the extent to which they describe the fiscal control and accounting procedures that will be used to ensure prudent use, proper disbursement, and accurate accounting of funds received under this program announcement (5 points).
Each application submitted under this program announcement will undergo a pre-review to determine that (1) the application was received by the closing date and submitted in accordance with the instructions in this announcement and (2) the applicant is eligible for funding. Applications which pass the initial EAC screening will be evaluated and rated by an independent review panel on the basis of the specific evaluation criteria. The results of these reviews will assist the Commissioners of the EAC in considering competing applications. The scores determined by the Independent Review Panel will weigh heavily in funding decisions made by the EAC, but will not be the only factors considered. The evaluation criteria were designed to assess the quality of a proposed project, and to determine the likelihood of its success. The evaluation criteria are closely related and are considered as a whole in judging the overall quality of an application. Points are awarded only to applications which are responsive to the evaluation criteria within the context of this program announcement.
The successful applicant will be notified through the issuance of a Financial Assistance Award. The Financial Assistance Award will be signed by the Help America Vote College Program Director and transmitted via postal mail.
Organizations whose applications will not be funded will be notified in writing by the U.S. Election Assistance Commission.
The EAC has not promulgated any such requirements at this time. It is expected that general administrative and national policy requirements will be followed, and the EAC will seek guidance on these requirements from other Federal agencies, such as the U.S. Department of Health and Human Services.
All grantees are required to submit monthly program reports to the EAC; grantees are also required to submit expenditure reports using the required financial standard form (SF-269) which is located on the Internet at:
Program Office Contact: Karen Lynn-Dyson, Program Director, Help America Vote College Program, U.S. Election Assistance Commission, 1225 New York Avenue, NW., Suite 1100, Washington, DC 20005, Phone: (202) 566-3100; Fax (202) 566-1389; e-mail:
Additional information about the U.S. Election Assistance Commission and its purpose can be found on the following Internet address:
Thank you for your interest in improving the voting process in America.
Office of Energy Efficiency and Renewable Energy, Department of Energy.
Decision and Order.
Notice is given of the Decision and Order (Case No. CAC-008) granting a Waiver to Mitsubishi Electric and Electronics USA, Inc. (MEUS) from the existing Department of Energy (DOE or Department) commercial package air conditioner and heat pump test procedure for its City Multi products.
Dr. Michael G. Raymond, U.S. Department of Energy, Building Technologies Program, Mail Stop EE-2J, Forrestal Building, 1000 Independence Avenue, SW., Washington, DC 20585-0121, (202) 586-9611, E-mail:
In accordance with Title 10, Code of Federal Regulations Part 431.29(f)(4), notice is hereby given of the issuance of
Title III of the Energy Policy and Conservation Act (EPCA) sets forth a variety of provisions concerning energy efficiency. Part B of Title III (42 U.S.C. 6291-6309) provides for the AEnergy Conservation Program for Consumer Products other than Automobiles.” Part C of Title III (42 U.S.C. 6311-6317) provides for a program entitled ACertain Industrial Equipment,” which is similar to the program in Part B, and which includes commercial air conditioning equipment, packaged boilers, water heaters, and other types of commercial equipment.
Today's decision and order involves commercial equipment under Part C, which specifically provides for definitions, test procedures, labeling provisions, energy conservation standards, and the authority to require information and reports from manufacturers. With respect to test procedures, Part C generally authorizes the Secretary of Energy to prescribe test procedures that are reasonably designed to produce results which reflect energy efficiency, energy use and estimated annual operating costs, and that are not unduly burdensome to conduct.
For commercial package air-conditioning and heating equipment, EPCA provides that the test procedures shall be those generally accepted industry testing procedures developed or recognized by the Air-Conditioning and Refrigeration Institute (ARI) or by the American Society of Heating, Refrigerating and Air Conditioning Engineers (ASHRAE), as referenced in ASHRAE/IES (IES is the Illuminating Engineering Society of North America) Standard 90.1 and in effect on June 30, 1992. (42 U.S.C. 6314(a)(4)(A)) This section also allows the Secretary of Energy to amend the test procedure for a product if the industry test procedure is amended, unless the Secretary determines that such a modified test procedure does not meet the statutory criteria. (42 U.S.C. 6314(a)(4)(B)).
The relevant test procedure for the purposes of today's decision and order and referenced in the version of ASHRAE 90.1 in effect in 1992 is ARI 210/240 (1989), “Standard for Unitary Air-Conditioning and Air-Source Heat Pump Equipment.” The Air-Conditioning and Refrigeration Institute subsequently modified the 1989 version of the test procedure. The Department issued a Notice of Proposed Rulemaking proposing to adopt ARI 210/240 (1994) (65 FR 48828, Aug. 9, 2000), but has not taken final action with respect to that proposal. Thus, the currently applicable test procedure is contained in ARI Standard 210/240 (1989).
The Department's regulations contain provisions allowing a person to seek a waiver from the test procedure requirements for covered consumer products and electric motors. These provisions are set forth in 10 CFR 430.27 and 10 CFR 431.29. However, there are no waiver provisions for other covered commercial equipment. The Department proposed waiver provisions for covered commercial equipment on December 13, 1999 (64 FR 69597), as part of the commercial furnace test procedure rule. The Department expects to publish a final rule codifying this process in 10 CFR 431.201. Until that time, DOE will apply to commercial equipment the waiver provisions for consumer products and electric motors. These waiver provisions are substantively identical.
The waiver provisions allow the Assistant Secretary for Energy Efficiency and Renewable Energy to waive temporarily the test procedure for a particular basic model when a petitioner shows that the basic model contains one or more design characteristics that prevent testing according to the prescribed test procedures, or when the prescribed test procedures may evaluate the basic model in a manner so unrepresentative of its true energy consumption as to provide materially inaccurate comparative data. (10 CFR 430.27 (l), 10 CFR 431.29 (f)(4)) Waivers generally remain in effect until final test procedure amendments become effective, thereby resolving the problem that is the subject of the waiver.
On June 13, 2003, MEUS submitted a Petition for Waiver from the test procedures applicable to commercial package air conditioning and heating equipment. MEUS requested a waiver from the applicable test procedures because, MEUS asserts, the current test procedures evaluate its CITY MULTI Variable Refrigerant Flow Zoning (VRFZ) system products in a manner so unrepresentative of their true energy consumption characteristics as to provide materially inaccurate comparative data.
In particular, MEUS requested a waiver from the currently applicable test procedures contained in ARI 210/240 (1989), and from the test procedures contained in ARI 210/240 (1994), which the Department has proposed to adopt. On September 16, 2003, the Department published MEUS's Petition for Waiver, and solicited comments, data, and information respecting the petition. 68 FR 54212.
The Department received three written comments, from Carrier Corporation (Carrier), Lennox International Inc. (Lennox), and Samsung Air Conditioning (Samsung), concerning the Petition for Waiver. One of the comments (Samsung) supported granting the waiver, and two of the comments (Carrier and Lennox) were opposed.
MEUS’ petition presented several arguments in support of its claim that the current test procedures evaluate CITY MULTI VRFZ system products in a manner so unrepresentative of their true energy consumption characteristics as to provide materially inaccurate comparative data. One argument concerned the complexity of testing VFRZ systems. The current test procedure can be used to test all current commercial systems in the laboratory, but many VFRZ systems cannot be tested in the laboratory. Each VFRZ outdoor unit can be connected with up to sixteen separate indoor units in a zoned system. Existing test laboratories cannot test more than five indoor units at a time, and even that number is difficult.
A second difficulty is that MEUS offers 58 indoor unit models. Each of these indoor unit models is designed to be used with up to 15 other indoor units, which need not be the same models, in combination with a single outdoor unit. For each of the CITY MULTI VRFZ outdoor coils, there are well over 1,000,000 combinations of indoor coils that can be matched up in a system configuration, and it is highly impractical to test so many combinations.
There are therefore two major testing problems: (1) Test laboratories cannot test products with so many indoor units; and (2) there are too many possible combinations of indoor and outdoor units— only a small fraction of the combinations could be tested. These problems do not support MEUS' claim that the “current test procedures
In its comments on the waiver petition, Carrier addressed the first problem, stating that testing units with two or three indoor sections would be a good check on the rating accuracy. Lennox addressed the second problem, suggesting that the Petitioner present engineering analysis to establish a method of sampling a range of performance. The Department does not believe that the solutions embodied in either comment are a sufficient answer to the difficulties. These solutions would not provide a rating comparable in accuracy with the current test procedure as applied to a typical commercial system with one indoor and one outdoor unit. Furthermore, neither commenter addressed the problem of the test procedure's not having been designed to cover zoned systems.
The remainder of MEUS' assertions, and the comments upon them, relate to the energy efficiency descriptor, the energy efficiency ratio (EER). MEUS asserts: (1) The test procedure does not accommodate infinite variability in compressor speeds; (2) full load EER measurements are not representative of customer usage at part loads; and (3) the test procedure does not account for simultaneous heating and cooling. In short, MEUS asserts the test procedure for EER does not capture the energy savings of VFRZ products. While this assertion is true, it is irrelevant because the full load EER energy efficiency descriptor is the one mandated by EPCA for these products (42 U.S.C. 6313(a)(1)(c)), and the relevant energy performance is the peak load efficiency, not the seasonal energy savings. Therefore, a waiver can only be granted if a test procedure does not fairly represent the peak load energy consumption characteristics which EER measures. The Department is not convinced that the test procedures do not fairly represent the true (peak load) energy consumption characteristics as measured by EER. However, the two testing problems discussed above, (test laboratories cannot test products with so many indoor units, and there are too many possible combinations of indoor and outdoor units to test), do prevent testing of the basic model according to the prescribed test procedures.
The Department consulted with The Federal Trade Commission (FTC) concerning the MEUS Petition. The FTC did not have any objections to the issuance of the waiver to MEUS. The Department also consulted with the National Institute of Standards & Technology (NIST), who agreed that many VFRZ systems could not be tested in the laboratory.
After careful consideration of all the material that was submitted by MEUS, the comments received, the review by NIST, and consultation with the FTC, it is ordered that:
(1) The “Petition for Waiver” filed by Mitsubishi Electric and Electronics USA, Inc. (MEUS) (Case No. CAC-008) is hereby granted as set forth in paragraph (2) below.
(2) MEUS shall be not be required to test or rate its CITY MULTI Variable Refrigerant Flow Zoning System (VFRZ) products listed below on the basis of the currently applicable test procedure:
(3) This waiver shall remain in effect from the date of issuance of this Order until DOE prescribes final test procedures appropriate to the model series manufactured by MEUS and listed above.
(4) This waiver is based upon the presumed validity of statements, allegations, and documentary materials submitted by the petitioner. This waiver may be revoked or modified at any time upon a determination that the factual basis underlying the Petition is incorrect.
Department of Energy.
Notice of open meeting.
This notice announces an open meeting of the Biomass Research and Development Technical Advisory Committee under the Biomass Research and Development Act of 2000. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that agencies publish these notices in the
September 29, 2004.
Hilton Crystal City Hotel at National Airport,2399 Jefferson Davis Highway,Arlington, VA 22202.
Don Richardson, Designated Federal Officer for the Committee, Office of Energy
• The Biomass R&D Technical Advisory Committee will meet to develop the 2004 Recommendations to the Secretaries of Energy and Agriculture.
• The Biomass R&D Technical Advisory Committee will begin developing its 2005 Work Plan.
Environmental Protection Agency (EPA).
Notice.
In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
Comments must be submitted on or before October 26, 2004.
Submit your comments, referencing docket ID number ORD-2004-0013, to EPA online using EDOCKET (our preferred method), by e-mail to the Office of Environmental Information (OEI) Docket,
Elizabeth T. Hunike, U.S. Environmental Protection Agency, Human Exposure and Atmospheric Sciences Division, Process Modeling Research Branch, Mail Drop D205-03, Research Triangle Park, NC 27711; telephone number: (919) 541-3737; facsimile number: (919) 541-1153; e-mail:
EPA has established a public docket for this ICR under Docket ID number ORD-2004-0013, which is available for public viewing at the Office of Environmental Information Docket in the EPA Docket Center (EPA/DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is (202) 566-1744, and the telephone number for the Office of Environmental Information Docket is (202) 566-1752. An electronic version of the public docket is available through EPA Dockets (EDOCKET) at
Any comments related to this ICR should be submitted to EPA within 60 days of this notice. EPA's policy is that public comments, whether submitted electronically or on paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. For further information about the electronic docket, see EPA's
A response to this collection of information is voluntary, but it is required to obtain the benefit of EPA designation under 40 CFR Part 53. Submission of some information that is claimed by the applicant to be confidential business information may be necessary to make a reference or equivalent method determination. The confidentiality of any submitted information identified as confidential business information by the applicant will be protected in full accordance with 40 CFR Part 53.15 and all applicable provisions of 40 CFR Part 2.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR Part 9 and 48 CFR Chapter 15.
(i) 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;
(ii) Evaluate the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(iii) Enhance the quality, utility, and clarity of the information to be collected; and
(iv) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology,
The annual public reporting and recordkeeping burden for this collection of information is estimated to average approximately 4,720 hours, with a cost of approximately $93,000. These estimates are based on a projected receipt of 5 major applications per year with a weighted average burden of 860 hours per application, and an estimated 14 minor applications per year with a weighted average burden of 30 hours each. However, it should be noted that actual applications range widely in content and extent. Accordingly, the individual respondent burden for a particular application response may differ substantially from these weighted average burden estimates. The weighted average cost burden estimate includes start up costs, the total cost of capital equipment annualized over its expected useful life, operation and maintenance, and purchase of services.
Environmental Protection Agency (EPA).
Notice.
In compliance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), this notice announces that EPA is seeking public comment on the following Information Collection Request (ICR): Application and Summary Report for an Emergency Exemption for Pesticides (EPA ICR No. 0596.09, OMB Control No. 2070-0032). This is a request to renew an existing ICR that is currently approved and due to expire November 30, 2004. The ICR describes the nature of the information collection activity and its expected burden and costs. Before submitting this ICR to the Office of Management and Budget (OMB) for review and approval under the PRA, EPA is soliciting comments on specific aspects of the collection.
Written comments, identified by the docket identification (ID) number OPP-2004-0252, must be received on or before October 26, 2004.
Comments may be submitted electronically, by mail, or through hand delivery/courier. Follow the detailed instructions as provided in Unit III. of the
Nathanael Martin, Field and External Affairs Division (7506C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-6475; fax number: (703) 305-5884; e-mail address:
You may be potentially affected by this action if you are a Federal Agency, U.S. territory, or State Agency responsible for the regulation of pesticides. Potentially affected entities may include, but are not limited to:
• Federal and State Agencies responsible for regulating pesticides (NAICS 92614), e.g., regulation of agricultural marketing and commodities.
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed above could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
EPA has established an official public docket for this action under docket identification (ID) number OPP-2004-0252. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1801 South Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.
You may access this
An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at
Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit II.A. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket.
For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.
You may submit comments electronically, by mail, or through hand delivery/courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit III.B. Do not use EPA Dockets or e-mail to submit CBI or information protected by statute.
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Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e-mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI (if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.
In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under
You may find the following suggestions helpful for preparing your comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used that support your views.
4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Offer alternative ways to improve the collection activity.
7. Make sure to submit your comments by the deadline in this notice.
8. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and
Pursuant to section 3506(c)(2)(A) of the PRA, EPA specifically solicits comments and information to enable it to:
1. Evaluate whether the proposed collections of information are 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 estimates of the burdens of the proposed collections of information.
3. Enhance the quality, utility, and clarity of the information to be collected.
4. Minimize the burden of the collections of information on those who are to respond, including through the use of appropriate automated or electronic collection technologies or other forms of information technology, e.g., permitting electronic submission of responses.
EPA is seeking comments on the following ICR:
Under the PRA, “burden” means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal Agency. For this collection it includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.
The ICR provides a detailed explanation of this estimate, which is only briefly summarized in this notice. The annual public burden for this ICR is estimated to be 49,500. The following is a summary of the estimates taken from the ICR:
The overall respondent burden has decreased due to the drop in the overall number of section 18 emergency exemption applications annually from 600 for the period of 1998-2000 to approximately 500 for the period of 2001-2003. This trend is attributed to the Agency's focus and priority on making registration decisions for repeated section 18 emergency exemption uses quickly. For instance, in 2003 registration decisions for 120 uses
EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval pursuant to 5 CFR 1320.12. EPA will issue another
Environmental protection, Reporting and recordkeeping requirements.
Availability of EPA comments prepared pursuant to the Environmental Review Process (ERP), under Section 309 of the Clean Air Act and Section 102(2)(c) of the National Environmental Policy Act, as amended. Requests for copies of EPA comments can be directed to the Office of Federal Activities at (202) 564-7167. An explanation of the ratings assigned to draft environmental impact statements(EISs) was published in FR dated April 2, 2004 (69 FR 17403).
Environmental Protection Agency (EPA).
Notice of meeting.
Pursuant to the Federal Advisory Committee Act, Public Law 92-463, the Environmental Protection Agency, Office of Research and Development (ORD), gives notice of an Executive Committee meeting of the Board of Scientific Counselors (BOSC).
The meeting will be held on Wednesday, September 22, 2004 from 9:30 a.m. to 5:30 p.m. Time has been allotted from 8:30 a.m. to 9:30 a.m. for BOSC members of four subcommittees (Endocrine Disrupting Chemicals (EDCs), Computational Toxicology, Global Change, and Mercury) to meet prior to the Executive Committee meeting. The meeting will continue on Thursday, September 23, 2004 from 8:30 a.m. to 3:15 p.m. All times noted are eastern time. The meeting may adjourn early on Thursday if all business is finished.
The meeting will be held at the Washington Plaza Hotel, 10 Thomas Circle NW., Washington, DC 20005.
Any member of the public interested in receiving a draft BOSC agenda or making a presentation at the meeting may contact Ms. Lorelei Kowalski, Designated Federal Officer, via telephone/voice mail at (202) 564-3408, via e-mail at
In general, each individual making an oral presentation will be limited to a total of three minutes. Requests for the draft agenda or for making oral presentations at the meeting will be accepted up to 1 business day before the meeting date. The draft agenda can also be viewed through EDOCKET, as provided in Unit I.A. of the
Comments may be submitted electronically, by mail, or through hand delivery/courier. Follow the detailed instructions as provided in Unit I.B. of the
Ms. Lorelei Kowalski, Designated Federal Officer, via telephone/voice mail at (202) 564-3408, via e-mail at
Proposed agenda items for the meeting include, but are not limited to: Briefings on ORD's nanotechnology program and EMAP; discussion of BOSC review of ORD research programs; update on review committees for mercury, computational toxicology, endocrine disruptors, and global change; discussion of a proposal to hold a risk assessment workshop in 2005, ORD's Biotechnology Research Strategy and Coastal Health report, and interagency relationships; update on EPA's Science Advisory Board activities; discussion of the BOSC's FY05 work agenda; and future issues and plans (including the Communications and Nomination Subcommittees). The meeting is open to the public.
Information on Services for the Handicapped: Individuals requiring special accommodations at this meeting should contact Lorelei Kowalski, Designated Federal Officer, at (202) 564-3408, at least five business days prior to the meeting so that appropriate arrangements can be made to facilitate their participation.
EPA has established an official public docket for this action under Docket ID No. ORD-2004-0014. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Documents in the official public docket are listed in the index in EPA's electronic public docket and comment system, EDOCKET. Documents may be available either electronically or in hard copy. Electronic documents may be viewed through EDOCKET. Hard copy of the draft agenda may be viewed at the Board of Scientific Counselors, Executive Committee Meeting-Fall-04 Docket in the EPA Docket Center (EPA/DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the ORD Docket is (202) 566-1752.
You may access this
An electronic version of the public docket is available through EDOCKET. You may use EDOCKET at
For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, confidential business information (CBI), or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the Docket will be scanned and placed in EPA's electronic public docket.
You may submit comments electronically, by mail, or through hand delivery/courier. To ensure proper receipt by EPA, identify the appropriate docket identification number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period.
If you submit an electronic comment as prescribed below, EPA recommends that you include your name, mailing address, and an e-mail address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.
Send your comments to: U.S. Environmental Protection Agency, ORD Docket, EPA Docket Center (EPA/DC), Mailcode: 28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, Attention: Docket ID No. ORD-2004-0014.
Deliver your comments to: EPA Docket Center (EPA/DC), Room B102, EPA West Building, 1301 Constitution Avenue, NW., Washington, DC, Attention: Docket ID No. ORD-2004-0014. (
Environmental Protection Agency (EPA).
Notice.
This notice announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities.
Comments, identified by docket identification (ID) number OPP-2004-0292, must be received on or before September 27, 2004.
Comments may be submitted electronically, by mail, or through hand delivery/courier. Follow the detailed instructions as provided in Unit I. of the
Cynthia Giles-Parker, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460--0001; telephone number: (703) 305-7740; e-mail address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, pesticide manufacturer, or consume agricultural commodities. Potentially affected entities may include, but are not limited to:
• Crop production (NAICS 111)
• Farming (NAICS 112)
• Food manufacturing (NAICS 311)
• Pesticide manufacturing (NAICS 32532)
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
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An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at
Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket.
For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.
You may submit comments electronically, by mail, or through hand delivery/courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I.D. Do not use EPA Dockets or e-mail to submit CBI or information protected by statute.
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Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e-mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI (if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or
In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under
You may find the following suggestions helpful for preparing your comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used that support your views.
4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Make sure to submit your comments by the deadline in this notice.
7. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and
EPA has received pesticide petitions as follows proposing the establishment and/or amendment of regulations for residues of a certain pesticide chemical in or on various food commodities under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. EPA has determined that these petitions contain data or information regarding the elements set forth in FFDCA section 408(d)(2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petitions. Additional data may be needed before EPA rules on the petitions.
Environmental protection, Agricultural commodities, Feed additives, Food additives, Pesticides and pests, Reporting and recordkeeping requirements.
The petitioner summary of the pesticide petitions is printed below as required by FFDCA section 408(d)(3). The summary of the petitions was prepared by the petitioner and represents the view of the petitioner. The petition summary announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed.
EPA has received three pesticide petitions (PP 0F6139, 2F6431, and 3F6581) from BASF Corporation, Research Triangle Park, NC 27709, proposing pursuant to section 408(d) of the FFDCA, 21 U.S.C. section 346a (d), to amend 40 CFR part 180.582 by establishing tolerances for the combined residues of the fungicide pyraclostrobin (carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl]methoxy-, methyl ester) and its metabolite BF 500-3 (methyl-
EPA has also received a pesticide petition (PP 3E6774) from Interregional Research Project Number 4 (IR-4), 681 U.S. Highway #1 South, North Brunswick, NJ 08902-3390, proposing pusuant to section 408(d) of the FFDCA, 21 U.S.C. section 346a (d) to amend 40 CFR part 180.582 by establishing tolerances for the combined residues of the fungicide pyraclostrobin and its metabolite BF 500-3 in or on vegetables, leafy, except brassica, group 4 29 ppm.
EPA has determined that the petitions contain data or information regarding the elements set forth in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of these petitions. Additional data may be needed before EPA rules on the petitions. This summary has been prepared by BASF Corporation, Research Triangle Park, NC 27709.
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• Ames test (one study of point mutation): Negative.
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No teratogenic effects were noted in either the rat or rabbit developmental studies. In the rat study, maternal toxicity observed at the mid and high dose consisted of decreased food consumption and body weight gain. Developmental changes noted at the high dose were increased incidences of dilated renal pelvis and cervical ribs with no cartilage. The maternal NOAEL was 10 mg/kg bw/day and the developmental NOAEL was 25 mg/kg bw/day. In the rabbit teratology study, maternal toxicity observed at the mid and high doses consisted of decreased food consumption and body weight gain (severe at the high dose). An increased postimplantation loss was also observed at the mid and high doses due to an increase in early resorptions. In rabbits, these types of effects are often observed with significant stress on the mothers (as seen by the body weight gain decrease in this study) and are not indicative of frank developmental toxicity. The NOAEL for both maternal and developmental toxicity was 5 mg/kg bw/day.
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In an oncogenicity study, pyraclostrobin was administered to groups of 50 male and 50 female Wistar rats at dietary concentrations of 0, 25, 75, and 200 ppm for 24 months. In a companion chronic toxicity study, 20 rats/sex were used at the same dose levels as in the oncogenicity study. A body weight gain depression of 10-11% in males and 14-22% in females with an accompanying decrease in food efficiency was observed at the high dose. The only other effect observed was a decrease in serum alkaline phosphatase in both sexes at the high dose and decreased alanine aminotransferase in high dose males. There was no evidence that pyraclostrobin produced a carcinogenic effect in rats. The NOAEL for the chronic rat and the cancer rat study is 75 ppm (ca. 3.4 mg/kg bw/day males; 4.6 mg/kg bw/day females).
Pyraclostrobin was administered to groups of 50 male and 50 female B6C3F1 mice at dietary concentrations of 0, 10, 30, 120, and 180 ppm (females
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The acute and chronic dietary exposure estimates were based on proposed tolerance values for most crops:
• Measured residue values for vegetables, leafy, except brassica, group 4.
• Percent crop treated.
• Concentration/processing factors.
• Consumption data from the United States Department of Agriculture (USDA) Continuing Survey of Food Intake by Individuals (CSFII 1994-1996, 1998) and the EPA Food Commodity Ingredient Database (FCID) using Exponent's Dietary Exposure Evaluation Module (DEEM-FCID, version 2.03) software.
Results of exposure estimates were compared against the pyraclostrobin chronic Population Adjusted Dose (cPAD) and acute Population Adjusted Dose (aPAD) of 0.034 mg/kg bw/day and 0.3 mg/kg bw/day for the general population, respectively. For females of child bearing years (13-49 years old) the aPAD is 0.05 mg/kg bw/day. The EPA determined that the FQPA Safety Factor should not be retained and reduced it to 1X for all exposure scenarios. Therefore, the aPAD and cPAD are the same as the aRfD (acute Reference Dose) and cRfD (chronic Reference Dose), respectively.
Results of the chronic dietary assessments are listed in Table 1. The estimated chronic dietary exposure from pending crops was less than 10% of the cPAD for all subpopulations. Additional refinements such as the use of anticipated residues would further reduce the estimated chronic dietary exposure.
As Table 2. shows, the estimated acute dietary exposure was under the aPAD at the 99th and 99.9th percentile. The overall general U.S. population and the most sensitive subpopulation (females 13-49 years) utilized
To ensure that these additional uses on the proposed crops fit within the total risk cup, a dietary exposure assessment (considering tolerance values; anticipated residues for measured residue values for vegetables, leafy, except brassica, group 4; concentration/processing factors; and percent crop treated values) was conducted using all currently registered and proposed crop uses (from both IR-4 and BASF) for pyraclostrobin. This assessment also included the current tolerance values for secondary residues in meat, meat byproducts, liver, and milk. The maximum chronic exposure estimates remained below 25% of the cPAD for the U.S. and all subgroup populations. The acute dietary exposure was 6% (99th percentile) and 16.7% (99.9th percentile) of the aPAD for the general U.S. population. For females (13-49 years), the most sensitive subpopulation, the acute dietary exposure was 31.1% (99th percentile) and 95.9% (99.9th percentile) of the aPAD. Additional refinements with anticipated residues rather than tolerance values would further reduce the estimated dietary exposures.
Results of the chronic (Table 3.) and acute (Table 4.) dietary exposure analysis demonstrate a reasonable certainty that no harm to the general U.S. population or any subpopulation would result from the use of pyraclostrobin on any of the currently registered or pending crops (both IR-4 and BASF uses).
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These results indicate that dietary exposure to pyraclostrobin (registered and all proposed crop uses), from potential residues in food and water, will not exceed EPA's level of concern (100% of aPAD or cPAD). Overall, we can conclude with reasonable certainty that no harm will occur from either acute or chronic dietary exposure to pyraclostrobin residues.
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Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” Pyraclostrobin is a foliar fungicide which belongs to the new class of strobilurin chemistry. It is a synthetic analog of strobilurin A, a naturally occurring antifungal metabolite of the mushroom Strobillurus tenacellus. The active ingredient acts in the fungal cell through inhibition of electron transport in the mitochondrial respiratory chain at the position of the cytochrome-bc1 complex. The protective effect is due to the resultant death of the fungal cells by disorganization of the fungal membrane system. Pyraclostrobin also acts curatively to prevent the increase and spread of fungal infections by inhibiting mycelial growth and sporulation on the leaf surface. BAS 500 F inhibits spore germination, germ tube growth, and penetration into the host tissues.
EPA is currently developing methodology to perform cumulative risk assessments. At this time, there are no available data to determine whether BAS 500 F has a common mechanism of toxicity with other substances or to show how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, pyraclostrobin does not appear to produce a toxic metabolite that is also produced by other pesticides.
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Maximum Residue Levels (MRLs) have been established for pyraclostrobin in Canada but no MRLs have been established by the Codex Alimentarius Commission.
Environmental Protection Agency (EPA).
Notice.
This notice announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities.
Comments, identified by docket identification (ID) number OPP-2004-0271, must be received on or before September 27, 2004.
Comments may be submitted electronically, by mail, or through hand delivery/courier. Follow the detailed instructions as provided in Unit I. of the
Mary Waller, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-9354; e-mail address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:
• Crop production (NAICS 111)
• Animal production (NAICS 112)
• Food manufacturing (NAICS 311)
• Pesticide manufacturing (NAICS 32532)
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
1.
2.
An electronic version of the public docket is available through EPA's
Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket.
For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.
You may submit comments electronically, by mail, or through hand delivery/courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I.D. Do not use EPA Dockets or e-mail to submit CBI or information protected by statute.
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i.
ii.
iii.
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Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e-mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI (if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.
In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public
You may find the following suggestions helpful for preparing your comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used that support your views.
4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Make sure to submit your comments by the deadline in this notice.
7. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and
EPA has received a pesticide petition as follows proposing the establishment and/or amendment of regulations for residues of a certain pesticide chemical in or on various food commodities under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. EPA has determined that this petition contains data or information regarding the elements set forth in FFDCA section 408(d)(2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition.
Environmental protection, Agricultural commodities, Feed additives, Food additives, Pesticides and pests, Reporting and recordkeeping requirements.
The petitioner summary of the pesticide petition is printed below as required by FFDCA section 408(d)(3). The summary of the petition was prepared by the petitioner and represents the view of the petitioner. The petition summary announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed.
EPA has received a pesticide petition (3E6572) from Ajay North America L.L.C., 1400 Industry Road, Powder Springs, Georgia 30127 proposing, pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 180 to establish an exemption from the requirement of a tolerance for iodine-potassium iodide in or on the raw agricultural commodities bananas, grapes, and melons. EPA has determined that the petition contains data or information regarding the elements set forth in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.
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Iodine is an essential element necessary to maintain human health and normal function of the thyroid gland. The effects of both iodine deficiency and excessive iodine intake in humans are well known and have been documented in a robust body of scientific literature. The levels of iodine intake considered optimal for various populations are based on Recommended Daily Allowances (RDAs) established by various Agencies. The proposed uses of iodine for disease and nematode control on grapes and melons, and for disease control on banana plants would not result in significant changes in iodine intake for any populations or subpopulations. Thus, the proposed use will not have any impact on individuals or subpopulations that are currently at risk for either deficiencies or excesses in iodine intake.
There is universal agreement on the dangers of iodine deficiency. Iodine deficiency is well known to result in a range of disorders including hypothyroidism, goiter, reproductive impairment and developmental abnormalities. While it is clear that excess iodine intake can cause adverse health effects, there are differences of opinion in the scientific community
A number of organizations, including Agency for Toxic Substances and Disease Registry (ATSDR), International Programme on Chemical Safety (IPCS), National Academy of Sciences, and the Joint Food and Agriculture Organization/World Health Organization (FAO/WHO) Expert Committee on Food Additives, have reviewed the literature regarding iodine and detailed its effects on human health. The toxicology information provided below has been assembled primarily from these sources.
Iodine has been approved by FDA for use in drugs and has been deemed GRAS as a food additive. There are also a number of antimicrobial uses already approved by the EPA for iodine and iodophors including sanitization of food handling equipment. A cleared review dated February 26, 1993 (Case No.3080, Toxicology Branch, Phase 4 Review, Pat McLaughlin) indicated that iodine and potassium iodide are well known in the literature, and while iodine is very irritating, it is not very toxic internally. EPA accepted the interchangeability of iodine and potassium iodide (EPA Cleared review dated July 5, 1996, Iodine Greybeard submission No. S496959, Toxicology Branch, Sanjivani Diwan). Potassium iodide is not toxic and has been deemed GRAS by the FDA as a food additive.
In an FDA Assessment entitled “Potassium Iodide and Potassium and Calcium Iodates: Proposed Affirmation of GRAS Status as Direct Human Food Ingredients with Specific Limitations” (42 FR 29925, June 10, 1977), the opinion of the Select Committee was that ingested potassium iodine and other iodides are readily absorbed and utilized to the extent required for nutritional needs, the excess being excreted primarily in the urine. There was no evidence in the studies on experimental animals and man available to the Committee that indicated acute or chronic toxic effects, including mutagenic, teratogenic, and carcinogenic effects, resulting from the consumption of potassium iodide by euthyroid individuals in amounts that are several orders of magnitude greater than those now being consumed in the daily diet.
In the 2002 National Academy of Sciences Report, the RDA of iodine for adult men and women is 0.15 mg/day (150 μg/day) and the Tolerable Upper Intake Level for adults is 1.1 mg/day. Intake varies considerably from day to day and the RDAs are based on average intakes. The RDA for children 1-8 years old is 0.09 milligram/day (mg/day) (90 μg/day). The Tolerable Upper Intake Level is 0.2 mg/day for children 1-3 years old, 0.3 mg/day for children 4-8 years old and 0.6 mg/day for children 9-13. The Tolerable Upper Intake Level is 0.9 mg/day for adolescents 14-18 years of age.
The Joint FAO/WHO Expert Committee on Food Additives assessed the human data on iodine for the purpose of establishing a maximum tolerated daily intake [661. Iodine (WHO Food Additives Series 24)]. The assessment concluded that iodine is an essential dietary element which is required for synthesis of thyroid hormones. The Committee concluded that the human response to excess iodine is variable and that the maximum tolerable level of iodine appears to be in the range from somewhat above recommended dietary allowances to one (1.0) mg/day. As indicated by Pennington (Pennington, J.A.T. (1990): A review of iodine toxicity reports. J. Am. Diet Assoc. 90: 1571-1581.), most people are very tolerant of excess iodine intake from food. Subpopulations with autoimmune thyroid disease and iodine deficiency respond adversely to intake of iodine, which would be considered safe for the general population.
The principal sources of iodine in the diet include, milk and dairy products, seafood, iodized salt and infant formula. The mean intake of iodine from food in the United States is 0.29 to 0.41 mg/day for females and males age 19 and above. For children 1-3 years old the mean intake is 0.3 mg/day, for children 4-8 years old the mean intake is 0.38 mg/day and for children 9-13 years old the mean intake is 0.38 to 0.49 mg/day. For adolescents 14-18 years of age, the mean intake is 0.33 to 0.53 mg/day. While this level of intake is considered adequate for the general population, the results of the National Health and Nutrition Examination Surveys I and III (NHANES I and III), conducted during the periods 1971-1974 and 1988-1994, respectively, show that the median iodine concentration in the population decreased more than 50% between the two surveys.
Residue trials of AJ1629 using maximum application rates on soil-treated grapes and melons and foliar applied bananas show that iodine residue levels in the food commodities are comparable for control and treated crops. Therefore, the proposed uses of iodine for disease and nematode control on grapes and melons, and for disease control on banana plants would not result in significant changes in iodine intake for any populations or subpopulations.
The toxicology data described below has been developed from human studies rather than animal studies. Therefore, an uncertainty factor is not needed to account for interspecies variability. The acute Minimal Risk Level (MRL) for iodine has been set at 0.01 milligram/kilogram/day (mg/kg/day) based on a NOAEL of 0.024 mg/kg/day for healthy adult humans. The chronic MRL is 0.01 mg/kg/day based on a no observed adverse effect level (NOAEL) of 0.01 mg/kg/day total iodide intake and a lowest observed effect level (NOAEL) of 0.029 mg/kg/day for subclinical hypothyroidism in healthy human children. An uncertainty factor is not needed to account for variability in sensitivity within species because the NOAEL is based on children, a sensitive subpopulation.
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To counteract the negative effects of iodine deficiency during pregnancy, the RDA for iodine in pregnant women is higher than that for the general population. In addition, the authors of the comparative iodine nutrition surveys, NHANES I (1971-1974) and III (1988-1994), voiced concern about the increased proportion of women of child-bearing age and pregnant women who
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Hypothyroidism is the primary effect of subchronic exposures to excess iodine. Below are summaries of several human studies conducted with iodine over 14 to 28 day periods. The ATSDR draft report has set the MRL for acute-duration oral exposure (1-14 days) at 0.01 mg/kg/day.
Several subchronic studies on humans were reviewed by ATSDR including one conducted on 18 healthy male and female adults over 14 days at daily oral doses of 1.5 mg I/day as sodium iodide with a background intake of 0.2 mg/day. The total iodide intake was approximately 1.7 mg I/day (approximately 0.024 mg/kg/day). There were significantly depressed serum concentrations of TT4, FT4 and TT3 and significantly elevated serum TSH concentrations compared with pretreatment levels. Hormone levels were within the normal range and, therefore, the subjects were not clinically hypothyroid.
Another study was conducted on ten healthy male adults over a 14-day period using oral doses of 0, 0.5, 1.5 and 4.5 mg I/day as sodium iodide. Including a background iodide intake of between 0.25-0.32 mg/day, total intake was 0.3, 0.8, 1.8 and 4.8 mg/day. These levels are approximately equivalent to 0.004, 0.011, 0.026 and 0.069 mg/kg/day. Small but significant, transient decreases in serum TT4 and FT4 concentrations and an increase in serum TSH concentrations were seen at the 1.8 and 4.8 mg/day dose level relative to the pretreatment values. The magnitude of the changes at the higher iodide dosages yielded hormone concentrations that were within the normal range and, thus, would not represent clinically significant thyroid suppression.
A 14 to 28 day study was conducted on 30 elderly adult females given daily doses of 0.5 mg I/day, with a background exposure of about 0.072-0.1 mg/day, for a total iodide intake of 0.6 mg/day or 0.0086 mg/kg/day. There were significantly decreased serum concentrations of FT4 but, on average, the magnitude of the changes did not produce clinically significant depression in thyroid hormone levels. Five subjects had serum TSH concentrations typically considered at the high end of the normal range.
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Chronic exposure to an excess of iodine primarily results in conditions such as hypothyroidism, hyperthyroidism, and/or thyroid autoimmunity. A NOAEL of 0.01 mg/kg/day and a LOAEL of 0.029 mg/kg/day were established for subclinical hypothyroidism in healthy human children. This NOAEL was used to set the MRL of 0.01 mg/kg/day for humans. The NOAEL was not adjusted for sensitivity, because it was based upon a sensitive subpopulation, children. The LOAEL based upon slight thyroid enlargement is not indicative of functional impairment.
Studies have shown that the chronic MRL for children, adults and the elderly is the same.
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As indicated by Pennington (1990), most people are very tolerant of excess iodine intake from food. Subpopulations with autoimmune thyroid disease and iodine deficiency respond adversely to intake of iodine, which would be considered safe for the general population. The principal effects of
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To our knowledge there are currently no available data or other reliable information indicating that any toxic effects produced by iodine would be cumulative with those of other chemical compounds; thus only the potential risks of iodine have been considered in this assessment of its aggregate exposure.
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There are no known international tolerances for residues of iodine- potassium iodide in food or animal feed.
Environmental Protection Agency (EPA).
Notice.
This notice announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities.
Comments, identified by docket identification (ID) number OPP-2004-0270, must be received on or before September 27, 2004.
Comments may be submitted electronically, by mail, or through hand delivery/courier. Follow the detailed instructions as provided in Unit I. of the
Sidney Jackson, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-7610; e-mail address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:
• Crop production (NAICS 111)
• Animal production (NAICS 112)
• Food manufacturing (NAICS 311)
• Pesticide manufacturing (NAICS 32532).
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. Other types of entities not listed in this unit could also be affected. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
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An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at
Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket.
For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.
You may submit comments electronically, by mail, or through hand delivery/courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I.D. Do not use EPA Dockets or e-mail to submit CBI or information protected by statute.
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Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e-mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI (if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.
In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM
You may find the following suggestions helpful for preparing your comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used that support your views.
4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Make sure to submit your comments by the deadline in this notice.
7. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and
EPA has received a pesticide petition as follows proposing the establishment and/or amendment of regulations for residues of a certain pesticide chemical in or on various food commodities under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. EPA has determined that this petition contains data or information regarding the elements set forth in FFDCA section 408(d)(2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition.
Environmental protection, Agricultural commodities, Feed additives, Food additives, Pesticides and pests, Reporting and recordkeeping requirements.
The petitioner summary of the pesticide petition is printed below as required by FFDCA section 408(d)(3). The summary of the petition was prepared by the petitioner and represents the view of the petitioner. The petition summary announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed.
EPA has received a pesticide petition (PP 3E6799) from the IR-4 Project, Center for Minor Crop Pest Management, Technology Centre of New Jersey. Rutgers, the State University of New Jersey, 681 U.S. Highway 1 South, North Brunswick, NJ 08902-3390 proposing, pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR 180.553 by establishing tolerances for residues of the fungicide, fenhexamid, (N-2,3-dichloro-4-hydroxypheny)-1-methyl cyclohexanecarboxamide), in or on the raw agricultural commodity fruit, pome, group 11 pre- and post-harvest at 10.0 parts per million (ppm) and apple, wet pomace at 25 ppm. EPA has determined that the petition contains data or information regarding the elements set forth in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition. The petition summary was prepared by the registrant, Arvesta Corporation, 100 First Street, San Francisco, CA 94106.
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ii. In rats, fenhexamid was administered by gavage at doses of 0 or 1,000 mg/kg for gestation days 6-15. No maternal toxicity, embryotoxicity, fetotoxicity, or teratogenic effects were observed at the limit dose of 1,000 mg/kg/day. Therefore, the NOAEL for maternal and developmental toxicity was 1,000 mg/kg/day.
iii. In rabbits, fenhexamid was administered by gavage at doses of 0,
Based on the 2-generation reproduction study in rats, Arvesta concludes that fenhexamid should not be considered a reproductive toxicant and shows no evidence of endocrine effects. The data from the developmental toxicity studies on fenhexamid show no evidence of a potential for developmental effects (malformations or variations) at doses that are not maternally toxic. The NOAEL for both maternal and developmental toxicity in rats was 1,000 mg/kg/day, and for rabbits the NOAEL for both maternal and developmental toxicity was 100 mg/kg/day.
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ii. Fenhexamid was administered in the diet to mice for approximately 14 weeks at doses of 0, 100, 1,000, and 10,000 ppm. The NOAEL was 1,000 ppm (266.6 mg/kg/day in males and 453.9 mg/kg/day in females). Increased feed and water consumption and kidney and liver effects were observed at 10,000 ppm.
iii. Fenhexamid was administered in the diet to beagle dogs for 13 weeks at doses of 0, 1,000, 7,000, and 50,000 ppm. The NOAEL was 1,000 ppm (33.9 mg/kg/day in males and 37.0 mg/kg/day in females). Increased Heinz bodies were observed at 7,000 ppm. .
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ii. A combined chronic/oncogenicity study was performed in Wistar rats. Fifty animals/sex/dose were administered doses of 0, 500, 5,000, or 20,000 ppm for 24 months in the feed. A further 10 animals/sex/group received the same doses and were sacrificed after 52 weeks. The doses administered relative to body weight were 0, 28, 292, or 1,280 mg/kg/day for males and 0, 40, 415, or 2,067 mg/kg/day for females. The NOAEL in the study was 500 ppm (28 mg/kg/day for males and 40 mg/kg/day for females) based on body weight decreases in females at 5,000 ppm and above, changes in biochemical liver parameters in the absence of morphological changes in both sexes at 5,000 ppm and above, and caecal mucosal hyperplasia evident at 5,000 ppm and above.
The NOAEL in the chronic dog study was 17.4 mg/kg/day based on body weight, hematology and clinical chemistry effects. The lowest NOAEL in the 2-year rat study was determined to be 28 mg/kg/day based on body weight, clinical chemistry parameters in the liver, and caecal mucosal hyperplasia.
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ii. Rats were administered radiolabeled fenhexamid (a single oral low dose of 1 mg/kg, a single oral high dose of 100 mg/kg, or 15 repeated low doses of 1 mg/kg/day). Radiolabeled fenhexamid was rapidly eliminated and tissue residues declined rapidly. After 48 hours the total radioactivity residue in the body excluding the GI tract, was
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Consideration of a common mechanism of fenhexamid toxicity is not appropriate at this time since it has a unique mode of action. Moreover, there is no significant toxicity observed for fenhexamid. Even at toxicology limit doses, only minimal toxicity is observed for fenhexamid. Therefore, only the potential risks of fenhexamid are considered in the exposure assessment.
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International tomato tolerances are in effect in France, Germany, Greece, Italy, Slovenia, Spain, Turkey (1 ppm) and other EU countries (2 ppm). Kiwi tolerances are as follows: Greece, Italy and Slovenia (10 ppm). Stonefruit tolerances already exist in the USA for pre-harvest applications as well as in Canada (6 ppm), Austria (cherry, 5 ppm; plum, 2 ppm); Belgium (cherry, 5 ppm); Germany and Slovenia (cherry, 5 ppm; peach and plum, 2 ppm), Italy (cherry, 5 ppm; apricot, peach and plum, 2 ppm); Japan (peach, 1 ppm), Switzerland (cherry, 2 ppm) and the UK (plum, 1 ppm) and other EU countries (peach and plum, 1 ppm; cherry, 5 ppm)
Environmental Protection Agency (EPA).
Notice.
This notice announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities.
Comments, identified by docket identification (ID)number OPP-2004-0288, must be received on or before September 27, 2004.
Comments may be submitted electronically, by mail, or through hand delivery/courier. Follow the detailed instructions as provided in Unit I. of the
Sidney Jackson, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-7610; e-mail address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:
• Crop production (NAICS 111)
• Animal production (NAICS 112)
• Food manufacturing (NAICS 311)
• Pesticide manufacturing (NAICS 32532)
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. Other types of entities not listed in this unit could also be affected. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
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2.
An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at
Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket.
For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.
You may submit comments electronically, by mail, or through hand delivery/courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I.D. Do not use EPA Dockets or e-mail to submit CBI or information protected by statute.
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Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e-mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI (if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.
In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under
You may find the following suggestions helpful for preparing your comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used that support your views.
4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Make sure to submit your comments by the deadline in this notice.
7. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and
EPA has received a pesticide petition as follows proposing the establishment and/or amendment of regulations for residues of a certain pesticide chemical in or on various food commodities under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. EPA has determined that this petition contains data or information regarding the elements set forth in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition.
Environmental protection, Agricultural commodities, Feed additives, Food additives, Pesticides and pests, Reporting and recordkeeping requirements.
The petitioner summary of the pesticide petition is printed below as required by section 408(d)(3) of the FFDCA. The summary of the petition was prepared by the petitioner and represents the view of the petitioner. The petition summary announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed.
EPA has received a pesticide petition (PP 4E6824) from the Interregional Research Project Number 4 (IR-4), 681 U.S. Highway 1 South, North Brunswick, NJ 08902-3390, proposing pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR 180.446 by establishing a tolerance for residues of the miticide, clofentezine, (3,6-bis (2-chlorophenyl)-1,2,4,5-tetrazine) in or on the raw agricultural commodity persimmon at 0.05 parts per million (ppm). EPA has determined that the petition contains data or information regarding the elements set forth in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. The registrant, Makhteshim-Agan of North America, Inc., New York, NY 10176 has prepared this summary in support of the pesticide petition. This summary does not necessarily reflect the findings of EPA. Additional data may be needed before EPA rules on the petition.
Clofentezine is marketed in the U.S. under tradenames including APOLLO SC. APOLLO
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The toxicology of clofentezine has been thoroughly evaluated by EPA as part of previous regulatory actions. The studies are considered to be valid, reliable and adequate for the purposes of evaluating potential health risks and for establishing tolerances. The primary studies submitted in support of the registration of clofentezine are summarized below.
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APOLLO SC is classified as toxicity category IV for oral toxicity and skin irritation, and as toxicity category III for dermal toxicity and eye irritation. The
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In a rat developmental toxicity study, clofentezine was administered by gavage at dose levels of 0, 320, 1, 280 and 3,200 mg/kg/day during gestation days 6 to 20. Evidence of maternal toxicity was noted at 3,200 mg/kg/day and consisted of decreased weight gain, increased liver weights and centrilobular hepatocellular enlargement. No developmental effects were observed at any dose level.
In a rabbit developmental toxicity study, clofentezine was administered by gavage at dose levels of 0, 250, 1,000 and 3,000 mg/kg/day during gestation days 7 to 28. Slight maternal toxicity (decreased maternal food consumption and weight gain) and a slight decrease in fetal weight were noted at 3,000 mg/kg/day. Thus, the NOAEL was considered to be 1,000 mg/kg/day for both maternal and developmental effects.
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In a subsequent 90-day feeding study, clofentezine was administered to rats at dietary concentrations of 0, 40, 400, and 4,000 ppm. Slightly reduced weight gain, alterations in several clinical pathology parameters, increased liver, kidney and spleen weights, and centrilobular hepatocyte enlargement were noted at 400 and/or 4,000 ppm. Thus, 40 ppm (2.8 mg/kg/day) was considered to be the NOAEL for this study.
Clofentezine was administered to beagle dogs for 90 days at dietary concentrations of 0, 3,200, 8,000 and 20,000 ppm. Increased liver weights were noted at all dose levels but no histopathological changes nor any other treatment-related effects were observed.
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In a 27-month feeding study, clofentezine was administered to rats at dietary concentrations of 0, 10, 40, and 400 ppm. Effects noted at 400 ppm were limited to the liver and thyroid, primarily of males, and consisted of increased liver weights, a variety of microscopic liver lesions (centrilobular hepatocyte hypertrophy and vacuolation, focal cystic hepatocellular degeneration and diffuse distribution of fat deposits), increased serum thyroxine levels, and a slight but statistically significant increase in the incidence of thyroid follicular cell tumors. The NOAEL was considered to be 40 ppm (2 mg/kg/day).
Clofentezine was not oncogenic to mice when administered for 2 years at dietary concentrations of 0, 50, 500, and 5,000 ppm. Decreased weight gain, increased liver weights, and increased mortality were noted at 5,000 ppm. An increased incidence of eosinophilic or basophilic hepatocytes was noted at 5,000 ppm, and possibly 500 ppm.
Numerous studies were conducted to investigate the mechanism for the increased incidence of male thyroid follicular tumors that was observed in the chronic rat study. These studies suggest that the tumors may have been caused by increased thyroid stimulating hormone (TSH) levels, which, in turn, resulted from clofentezine's liver toxicity, and were not attributable to a genotoxic mode of action.
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Following oral dosing of a cow and three goats with 14C-labeled clofentezine, the residue in milk was identified as a single metabolite, 4-hydroxyclofentezine. Similarly, 4-hydroxyclofentezine has been shown to be the only metabolite present in fat, liver, and kidney. No unchanged clofentezine or other metabolites were found. Therefore, the nature of the residue in animals is adequately understood. The residues of concern in ruminant commodities and milk are the combined residues of the parent, clofentezine, and the 4-hydroxyclofentezine metabolite.
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Based on these assumptions, the chronic dietary exposure estimates (DEEM) from the existing and proposed tolerances are well below the chronic RfD, ranging from 2.7% to 10.3% of the cRfD for the U.S. and its subpopulations.
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The estimated average concentration of clofentezine in surface drinking water (0.1 ppb) is far below the range of calculated DWLOCs: 442 ppb (U.S. population), 233 ppb (children 1-6 years) and 117 ppb (All infants
To our knowledge there are currently no available data or other reliable information indicating that any toxic effects produced by clofentezine would be cumulative with those of other chemical compounds; thus only the potential risks of clofentezine have been considered in this assessment of its aggregate exposure.
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Using worst-case assumptions of 100% percent crop treated, and that all crops and animal commodities contain residues of clofentezine at the current tolerance levels data maximum percent crop treated data, the aggregate exposure of the general population to clofentezine from the established and proposed tolerances utilizes about 8.7% of the chronic RfD or 2.7% if more realistic estimates of percent crop treated data have been used. The theoretical maximum residue contribution (TMRC) for the proposed use on persimmon is negligible. There is generally no concern for exposures, which utilize less than 100% of the RfD because the RfD represents the level at or below which daily aggregate exposure over a lifetime would not pose significant risks to human health. Therefore, Makhteshim-Agan concludes that there is a reasonable certainty that no harm will result to the general population from aggregate exposure to clofentezine residues.
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No indication of increased sensitivity to infants and children was noted in any of the studies with clofentezine. No developmental effects were noted in rats, even at a dose level (3,200 mg/kg/day) that exceeded the 1,000 mg/kg/day limit dose and produced maternal toxicity. In addition, no evidence of reproductive toxicity was noted in the rat multigeneration reproduction study. Slight developmental toxicity (decreased fetal weights) was noted in rabbits, but only at a dose level (3,000 mg/kg/day) that exceeded the EPA limit dose and also produced maternal toxicity.
FFDCA section 408 provides that EPA may apply an additional safety factor for infants and children to account for prenatal and postnatal toxicity and the completeness of the database. The toxicology database for clofentezine regarding potential prenatal and postnatal effects in children is complete according to existing Agency data requirements and does not indicate any developmental or reproductive concerns. Furthermore, the existing RfD is based on a NOAEL of 1.25 mg/kg/day (from the 1-year dog study), which is already more than 800-fold lower than the NOAEL in the rabbit developmental toxicity study. Thus, the registrant believes that the existing RfD of 0.0125 mg/kg/day is considered to be appropriate for assessing potential risks to infants and children and an additional uncertainty factor is not warranted.
Using the conservative exposure assumptions described above (proposed and current tolerances, 100% crop treated, and no adjustments for percent contribution from livestock diet), aggregate exposure to residues of clofentezine are expected to utilize about 48% of the RfD in non-nursing infants, 20% of the RfD in nursing infants, and 36% of the RfD in children aged 1 to 6 years old. Using more realistic estimates of percent crop treated, the percent of RfD utilized is less than or equal to 10% for these population subgroups. These numbers would be lowered further if anticipated residues and/or an adjustment for percent contribution from livestock diet were utilized rather than tolerance values. The residue contribution for the proposed use on persimmon is negligible. Therefore, Makhteshim-Agan concludes that there is reasonable certainty that no harm will result to infants or children from aggregate exposure to clofentezine residues.
There are no international maximum residue levels (MRL) established for clofentezine in or on the raw agricultural commodity, persimmon.
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 comments should be submitted on or before September 27, 2004. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all comments to Les Smith, Federal Communications Commission, Room 1-A804, 445 12th Street, SW., Washington, DC 20554 or via the Internet to
For additional information or copy of the information collection(s) contact Les Smith at (202) 418-0217 or via the Internet at
The FCC has determined that the information collection requirements affect “individuals or household” and has included the appropriate responses to address the Privacy Impact Assessment requirements as required by OMB Memorandum M-03-22 (September 22, 2003).
Federal Communications Commission.
Notice.
In this document, the Commission responds to an annual report required by the October 25, 2002
Effective July 28, 2004.
Federal Communications Commission, 445 12th Street, SW., Washington, DC 20554.
Cheryl King, (202) 418-2284 (voice), (202) 418-0416 (TTY), or e-mail
On October 25, 2002, the Commission released a
The full text of this document is available for public inspection and copying during regular business hours at the FCC Reference Information Center, Portals II, 445 12th Street, SW., Room CY-A257, Washington, DC 20554. This document may be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc. (BCPI), Portals II, 445 12th Street, SW., Room CY-B402, Washington, DC 20554. Customers may contact BCPI, Inc. at their Web site:
To request this document in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an e-mail to
Title IV of the Americans with Disabilities Act, which is codified at section 225 of the Communications Act of 1934, as amended (the Act), mandates that the Federal Communications Commission (Commission) ensure that interstate and intrastate telecommunications relay services (TRS) are available, to the extent possible and in the most efficient manner, to individuals in the United States with hearing and speech disabilities. Title IV aims to further the Act's goal of universal service by providing to individuals with hearing or speech disabilities telephone services that are functionally equivalent to those available to individuals without such disabilities. Since TRS became available on a nationwide basis in 1993, the Commission has taken numerous steps to increase the availability of TRS, and to ensure that TRS users have access to the same services available to all telephone service users. One of these services is access to public payphones.
In the
In the October 2002
The Commission identified six specific outreach and educational steps that it encouraged the pay telephone industry to take:
(a) Draft a consumer education letter, in consultation with deaf and hard-of-hearing advocacy groups, for dissemination to TRS users.
(b) Attend local, regional, and national consumer conferences of organizations that represent people who are deaf and hard-of-hearing, and distribute information.
(c) Post TRS instructions on or near pay telephones, to the extent possible.
(d) Make information available for TRS websites.
(e) Provide coin sent-paid TRS information in telephone directories.
(f) Consult with representatives of the deaf and hard-of-hearing communities to improve outreach and education methods for use of payphones for TRS calls.
On March 9, 2004, the CSP Industry Team filed its required report on outreach activities, detailing its response to each of the Commission's recommendations. The CSP Industry Team reports that:
(a)
(b)
(c)
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(e)
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On November 25, 2002—before the CSP Industry Team filed its required outreach report—Telecommunications for the Deaf, Inc. (TDI), The Consumer Action Network, The National Association of the Deaf, and Self-Help for Hard of Hearing People (Joint CSP Petitioners) filed a joint petition for reconsideration of the
In an
Because all outstanding coin sent-paid issues have now been resolved, the Commission will not request public comment on the CSP Industry Team's report. The Commission notes, however, that persons having concerns about coin sent-paid or other TRS issues may file informal complaints with the Commission, send letters to the Commission's Disability Rights Office, or file petitions for clarification or for the promulgation of new rules. The CSP
In accordance with § 271.25 of its rules regarding availability of information (12 CFR part 271), there is set forth below the domestic policy directive issued by the Federal Open Market Committee at its meeting held on June 29-30, 2004.
The Federal Open Market Committee seeks monetary and financial conditions that will foster price stability and promote sustainable growth in output. To further its long-run objectives, the Committee in the immediate future seeks conditions in reserve markets consistent with increasing the federal funds rate to an average of around 1-1/4 percent.
By order of the Federal Open Market Committee, August 18, 2004.
Office of Public Health and Science, Office of the Secretary, HHS.
Notice.
The National Vaccine Program Office (NVPO), a program office within the Office of Public Health and Science, DHHS, is soliciting nominations of qualified candidates to be considered for appointment as members to the National Vaccine Advisory Committee (NVAC). The activities of this Committee are governed by the stipulations of the Federal Advisory Committee Act (FACA). The current charter for the NVAC expires July 30, 2005.
Consistent with the National Vaccine Plan, the Committee advises and makes recommendations to the Assistant Secretary for Health in his/her capacity as the Director of the NVPO on matters related to the Program's responsibilities. Specifically, the Committee studies and recommends ways to encourage the availability of an adequate supply of safe and effective vaccination products in the United States; recommends research priorities and other measures to enhance the safety and efficacy of vaccines. The Committee also advises the Assistant Secretary for Health in the implementation of Sections 2102, 2103, and 2104 of the PHS Act; and identifies annually the most important areas of government and non-government cooperation that should be considered in implementing Sections 2102, 2103, and 2104 of the PHS Act.
Nominations for membership on the Committee must be received no later than 5 pm EST on October 31, 2004, at the address below.
Ms. Emma English, Program Analyst, National Vaccine Program Office, U.S. Department of Health and Human Services, Room 729.1-H Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201; (202) 690-5566.
A copy of the Committee charter and list of the current membership can be obtained by contacting Ms. English or by accessing the NVAC Web site at:
Nominations should be typewritten. The following information should be included in the package of material submitted for each individual being nominated for consideration: (1) A letter of nomination that clearly states the name and affiliation of the nominee, the basis for the nomination (
The Department makes every effort to ensure that the membership of DHHS Federal advisory committees is fairly balanced in terms of points of view represented and the committee's function. Every effort is made that a broad representation of geographic areas, gender, ethnic and minority groups, and the disabled are given consideration for membership on DHHS Federal advisory committees. Appointment to this Committee shall be made without discrimination on the basis of age, race, ethnicity, gender, sexual orientation, disability, and cultural, religious, or socioeconomic status.
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 (DHHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public.
The meeting will be held on October 5, 2004, from 9 a.m. to 3:30 p.m., and on October 6, 2004, from 9 a.m. to 3:30 p.m.
Department of Health and Human Services; Hubert H. Humphrey Building, Room 800; 200 Independence Avenue, SW., Washington, DC 20201.
Ms. Emma English, Program Analyst, National Vaccine Program Office, Department of Health and Human Services, Room 725H Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201; (202) 690-5566,
Pursuant to Section 2101 of the Public Service Act (42 U.S.C. 300aa-1), the Secretary of Health and Human Services was mandated to establish the National Vaccine Program (NVP) to achieve optimal prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines. The Secretary designated the Assistant Secretary for Health to serve as the Director, NVPO. The National Vaccine Advisory Committee (NVAC) was established to provide advice and make recommendations to the Director, NVPO, on matters related to the program's responsibilities.
Topics to be discussed at the meeting include: Pandemic Influenza and the Pandemic Influenza Response and Preparedness Plan and the NVAC Influenza Working Group's assessment of domestic influenza issues/needs. Updates will be given on the NVAC Working Group on Public Participation, the NVAC Working Group on Vaccine Financing, the NVAC Vaccine Safety and Communications Subcommittee, the NVAC Futures Vaccines Subcommittee, and the NVAC Immunization Coverage Subcommittee. A tentative agenda will be made available on or about September 21 for review on the NVAC Web site:
Public attendance at the meeting is limited to space available. Individuals must provide a photo ID for entry into the Humphrey Building. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the designated contact person. Members of the public will have the opportunity to provide comments at the meeting. Public comment will be limited to five minutes per speaker. Any members of the public who wish to have printed material distributed to NVAC members should submit materials to the Executive Secretary, NVAC, through the contact person listed above prior to close of business September 29, 2004. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meeting and/or participate in the public comment session should e-mail
Office of Public Health and Science, HHS; and Food, Nutrition and Consumer Services and Research, Education and Economics, USDA.
Notice.
The Department of Health and Human Services (HHS) and the Department of Agriculture (USDA) (a) announce the availability of the final Report of the Dietary Guidelines Advisory Committee on the Dietary Guidelines for Americans, 2005 (Report); (b) solicit written comments on the Report; and (c) provide notice of a public meeting to solicit oral comments on the Report. The meeting will be held at the Hubert H. Humphrey Building, 200 Independence Avenue, SW., Small Auditorium, Washington, DC, 20201. Registration is required to provide oral comments at the meeting and to attend the meeting.
(a) The final report of the Dietary Guidelines Advisory Committee (the Committee) will be available for comments on August 27, 2004. (b) Written comments on the Committee's report can be submitted and must be received by the Agencies on or before 5 p.m. E.D.T., September 27, 2004. (c) The public meeting to solicit oral comments on the report will be held on September 21, 2004 , starting at 9 a.m. E.D.T. Requests to present oral testimony must be received by 5 p.m. E.D.T., September 14, 2004.
(a) The final Report of the Committee is available electronically at
HHS Co-Executive Secretary: Kathryn McMurry (phone 240-453-8272), HHS Office of Disease Prevention and Health Promotion, Office of Public Health and Science, 1101 Wootton Parkway, Suite LL100, Rockville, MD 20852. USDA Co-Executive Secretaries: Carole Davis (phone 703-305-7600), USDA Center for Nutrition Policy and Promotion, 3101 Park Center Drive, Room 1034, Alexandria, Virginia 22302, or Pamela Pehrsson (phone 301-504-0716), USDA Agricultural Research Service, Beltsville Agricultural Research Center-West, Building 005, Room 309A, Beltsville, Maryland 20705. Additional information is available on the Internet at
The thirteen-member Dietary Guidelines Advisory Committee was appointed by the Departments of Health and Human Services and Agriculture in August, 2003 to assist the Departments in providing sound and current dietary guidance to consumers. The National Nutrition Monitoring and Related Research Act of 1990, Public Law 101-445, Title III, 7 U.S.C. 5301 et seq., requires the Secretaries of HHS and USDA to publish the Dietary Guidelines for Americans at least every five years. During its first meeting on September
The final report of the Dietary Guidelines Advisory Committee is available electronically at
By this notice, HHS and USDA are soliciting submission of written comments on the Committee's final Report, as well as views, information and data pertinent to preparation of Nutrition and Your Health: Dietary Guidelines for Americans. Comments must be received by 5 p.m. e.d.t. on September 27, 2004 to assure consideration. Comments may be submitted at
A public meeting to solicit oral comments on the Report will take place on September 21, 2004, starting at 9 a.m. e.d.t. The meeting will be held at the Hubert H. Humphrey Building, 200 Independence Avenue, SW., Small Auditorium, Washington, DC, 20201. The building is located 2 blocks from the Federal Center, SW. stop on the blue and orange metro lines. The agenda will include oral testimony from registered individuals or groups.
Department of Health and Human Services, Office of the Secretary.
Notice.
The National Vaccine Program Office (NVPO), Department of Health and Human Services, has drafted a plan to guide national preparedness and response to an influenza pandemic. The draft Pandemic Influenza Preparedness and Response Plan articulates a coordinated strategy to prepare and respond to an influenza pandemic and provides guidance to national, state, and local policy makers and health departments for public health preparation and response in the event of pandemic influenza outbreak. The draft plan includes a core section and twelve annexes. The core plan describes coordination and decision-making activities at the National level; provides an overview of key issues; and outlines action steps that should be taken at National, state, and local levels before and during a pandemic. Annexes provide additional information for health departments and private sector organizations, which can be used in developing local preparedness plans as well as additional technical information to support the core document.
Comments will be considered if we receive them at the appropriate address, as provided below, no later than 5 p.m. on October 26, 2004.
Attn: Pandemic Plan, National Vaccine Program Office, Hubert H. Humphrey Building, Room 725H, 200 Independence Avenue, SW., Washington, DC 20201 or by email at
Persons with access to the Internet may obtain the document at
Attn: Pandemic Plan, National Vaccine Program Office, Hubert H. Humphrey Building, Room 725H, 200 Independence Avenue, SW., Washington, DC 20201 or by email at
An influenza pandemic represents a major threat to health and may cause substantial social and economic disruption. Planning and implementing preparedness activities are critical to improving the effectiveness of a response and decreasing the impacts of a pandemic. The draft Pandemic Influenza Preparedness and Response Plan was developed to define national preparedness and response activities, and to guide planning activities that are underway at the State and local levels in both the public and private sectors. The plan is designed to be consistent with other health emergency preparedness and response plans while also recognizing the unique issues that an influenza pandemic would present.
There are several issues in the draft plan where options are being considered by the Department of Health and Human Services and final decisions are pending. Public comment on all aspects of the plan is being sought.
Centers for Medicare & Medicaid Services (CMS), HHS.
Notice.
This notice solicits nominations for members in two categories, patient representatives and State survey agency representatives, for which no nominations were received in response to our May 28, 2004
Nominations for membership will be considered if they are received by September 27, 2004.
Send nominations via mail or courier delivery to— Division of Acute Care, Mail stop C4-08-06, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Attention: Beverly J. Parker, or Via email to
Send written requests for copies of the EMTALA TAG Charter to—Division of Acute Care, Mail stop C4-08-06, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Attention: Marianne M. Myers
Beverly J. Parker (410) 786-5320.
Press inquiries are handled through the CMS Press Office at (202) 690-6145.
Sections 1866(a)(1)(I), 1866(a)(1)(N), and 1867 of the Social Security Act (the Act) impose specific obligations on Medicare-participating hospitals that offer emergency services. These obligations concern individuals who come to a hospital emergency department and request examination or treatment for medical conditions, and apply to all of these individuals, regardless of whether or not they are beneficiaries of any program under the Act. These provisions, taken together, are frequently referred to as the Emergency Medical Treatment and Labor Act (EMTALA), also known as the patient antidumping statute.
EMTALA was passed in 1986 as part of the Consolidated Omnibus Budget Reconciliation Act of 1985 (COBRA). Congress enacted these antidumping provisions in the Social Security Act because of its concern with an “increasing number of reports” that hospital emergency rooms were refusing to accept or treat individuals with emergency conditions if the individuals did not have insurance.
Regulations implementing the EMTALA legislation are set forth in 42 CFR 489.20(l), (m), (q) and (r)(1), (r)(2), (r)(3), and 489.24. These regulations incorporate changes made by a final rule published in the September 9, 2003
Section 945 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173), requires that the Secretary establish a Technical Advisory Group (TAG) for advice concerning issues related to EMTALA regulations and implementation. In the May 28, 2004
As explained in the May 28, 2004 notice, the Secretary signed the charter establishing the EMTALA TAG on May 11, 2004. This charter will terminate 30 months from the date of the EMTALA TAG's first meeting. The EMTALA TAG, as chartered, under the legal authority of section 945 of the MMA, is also governed by the provisions of the Federal Advisory Committee Act (FACA), 5 U.S.C. Appendix 2. In accordance with section 945 of the MMA, the EMTALA TAG will meet at least twice a year and all meetings will be open to the public.
You may obtain a copy of the Secretary's charter for the EMTALA TAG by mailing a written request to the address specified in the
Section 945 of the MMA specifies that the EMTALA TAG—
• Shall review the EMTALA regulations;
• May provide advice and recommendations to the Secretary concerning these regulations and their application to hospitals and physicians;
• Shall solicit comments and recommendations from hospitals, physicians, and the public regarding implementation of such regulations; and
• May disseminate information concerning the application of these regulations to hospitals, physicians, and the public.
The May 28, 2004 notice stated that section 945 of the MMA specifies the composition of the EMTALA TAG. It states that the EMTALA TAG will be composed of 19 members including the Administrator of the Centers for Medicare & Medicaid Services (CMS) and the Inspector General of the Department of Health and Human Services (DHHS) in addition to the number and type of individuals specified in each of the following categories:
• Four representatives of hospitals, including at least one public hospital, that have experience with the application of EMTALA and, at least, two hospitals that have not been cited for EMTALA violations;
• Seven practicing physicians drawn from the fields of emergency medicine, cardiology or cardiothoracic surgery, orthopedic surgery, neurosurgery, pediatrics or a pediatric subspecialty, obstetrics-gynecology and psychiatry,
• Two representatives of patients;
• Two staff persons involved in EMTALA investigations from different CMS regional offices;
• One representative from a State survey agency involved in EMTALA investigations and one representative from a Quality Improvement Organization (QIO), both of whom shall be from areas other than the regions represented by the CMS regional offices.
In response to our May 28, 2004 notice, we received nominations of individuals for the categories of hospital representatives, practicing physician representatives, staff persons involved in EMTALA investigations from CMS Regional Offices, and a QIO representative. Therefore, we are not seeking, and will not consider, any further nominations in any of these categories.
However, we did not receive any timely and complete nominations of individuals for two categories—(1) Patient representatives and (2) representative of a State survey agency involved in EMTALA investigations. Therefore, we are requesting nominations for membership on the EMTALA TAG in these categories. With respect to the category of patient representatives, the Secretary will consider qualified individuals who are nominated by organizations representing providers and patients. With respect to the category of State survey agency staff involved in EMTALA investigations, any interested person may nominate one or more qualified individuals (self-nominations will also be accepted). The Secretary will appoint members to serve on the EMTALA TAG from among those candidates determined to have the technical expertise required to meet specific agency needs and in a manner to ensure an appropriate balance of membership.
Each nomination must include the following:
1. A letter of nomination that contains—
a. Contact information for both the nominator and nominee (if not the same); and
b. The category, for which the nomination is being made (that is, either patient representative or representative of a State survey agency involved in EMTALA investigations).
2. A statement from the nominee that he or she is willing to serve on the EMTALA TAG for its duration (that is, at least 30 months from date of the first meeting) and an explanation of interest in serving on the EMTALA TAG. (For self-nominations, this information may be included in the nomination letter.)
3. A curriculum vitae that indicates the nominee's educational and EMTALA-related experiences.
4. Three letters of reference that support the nominee's qualifications for participation on the EMTALA TAG. (For nominations other than self-nominations, a nomination letter that includes information supporting the nominee's qualifications may be counted as one of the letters of reference.)
5. Additional information is required for representatives from a State survey agency—in your statement regarding serving on the EMTALA TAG indicate the extent of your experience with EMTALA investigations.
To ensure that a nomination is considered, we must receive all of the nomination information specified in section III of this notice by September 27, 2004.
Section 945 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA).
Centers for Medicare & Medicaid Services (CMS),HHS.
Notice.
Title XXI of the Social Security Act (the Act) authorizes payment of Federal matching funds to States, the District of Columbia, and U.S. Territories and Commonwealths to initiate and expand health insurance coverage to uninsured, low-income children under the State Children's Health Insurance Program (SCHIP). This notice sets forth the final allotments of Federal funding available to each State, the District of Columbia, and each U.S. Territory and Commonwealth for fiscal year 2005.
States may implement SCHIP through a separate State program under title XXI of the Act, an expansion of a State Medicaid program under title XIX of the Act, or a combination of both.
This notice is effective on September 27, 2004. Final allotments are available for expenditures after October 1, 2004.
Richard Strauss, (410) 786-2019.
This notice sets forth the allotments available to each State, the District of Columbia, and each U.S. Territory and Commonwealth for fiscal year (FY) 2005 under title XXI of the Social Security Act (the Act). Final allotments for a fiscal year are available to match expenditures under an approved State child health plan for 3 fiscal years, including the year for which the final allotment was provided. The FY 2005 allotments will be available to States for FY 2005, and unexpended amounts may be carried over to 2006 and 2007. Federal funds appropriated for title XXI are limited, and the law specifies a formula to divide the total annual appropriation into individual allotments available for each State, the District of Columbia, and each U.S. Territory and Commonwealth with an approved child health plan.
Section 2104(b) of the Act requires States, the District of Columbia, and U.S. Territories and Commonwealths to have an approved child health plan for the fiscal year in order for the Secretary to provide an allotment for that fiscal year. All States, the District of Columbia, and U.S. Territories and Commonwealths have approved plans for FY 2005. Therefore, the FY 2005 allotments contained in this notice pertain to all States, the District of Columbia, and U.S. Territories and Commonwealths.
This notice specifies, in the Table under section III, the final FY 2005
Section 2104(a) of the Act provides that, for purposes of providing allotments to the 50 States and the District of Columbia, the following amounts are appropriated: $4,295,000,000 for FY 1998; $4,275,000,000 for each FY 1999 through FY 2001; $3,150,000,000 for each FY 2002 through FY 2004; $4,050,000,000 for each FY 2005 through FY 2006; and $5,000,000,000 for FY 2007. However, under section 2104(c) of the Act, 0.25 percent of the total amount appropriated each year is available for allotment to the U.S. Territories and Commonwealths of Puerto Rico, Guam, the Virgin Islands, American Samoa, and the Northern Mariana Islands. The total amounts are allotted to the U.S. Territories and Commonwealths according to the following percentages: Puerto Rico, 91.6 percent; Guam, 3.5 percent; the Virgin Islands, 2.6 percent; American Samoa, 1.2 percent; and the Northern Mariana Islands, 1.1 percent.
Section 2104(c)(4)(B) of the Act provides for additional amounts for allotment to the Territories and Commonwealths: $34,200,000 for each FY 2000 through FY 2001; $25,200,000 for each FY 2002 through FY 2004; $32,400,000 for each FY 2005 through FY 2006; and $40,000,000 for FY 2007. Since, for FY 2005, title XXI of the Act provides an additional $32,400,000 for allotment to the U.S. Territories and Commonwealths, the total amount available for allotment to the U.S. Territories and Commonwealths in FY 2005 is $42,525,000; that is, $32,400,000 plus $10,125,000 (0.25 percent of the FY 2005 appropriation of $4,050,000,000).
Therefore, the total amount available nationally for allotment for the 50 States and the District of Columbia for FY 2005 was determined in accordance with the following formula:
For purposes of the following discussion, the term “State,” as defined in section 2104(b)(1)(D)(ii) of the Act, “means one of the 50 States or the District of Columbia.”
Under section 2104(b) of the Act, the States' SCHIP allotments for a particular fiscal year are determined based on two factors: The “number of children” and the “State cost factor.” The number of children is based on the three most recent March supplements to the Current Population Survey (CPS) of the Bureau of the Census officially available before the beginning of the calendar year in which the fiscal year begins. The State cost factor is based on the annual average wages per employee in the health services industry, which is determined using the most recent 3 years of such wage data as reported and determined as final by the Bureau of Labor Statistics (BLS) of the Department of Labor to be officially available before the beginning of the calendar year in which the fiscal year begins. Since FY 2005 begins on October 1, 2004 (that is, in calendar year 2004), in determining the FY 2005 SCHIP allotments, we are using the most recent official data from the Bureau of the Census and the BLS, respectively, available before January 1 of calendar year 2004 (that is, through the end of December 31, 2003).
For FY 2005, as specified by section 2104(b)(2)(A)(iii) of the Act, the number of children is calculated as the sum of 50 percent of the number of low-income, uninsured children in the State, and 50 percent of the number of low-income children in the State. The number of children factor for each State is developed from data provided by the Bureau of the Census based on the standard methodology used to determine official poverty status and uninsured status in the annual CPS on these topics. As part of a continuing formal process between the Centers for Medicare & Medicaid Services (CMS) and the Bureau of the Census, each fiscal year we obtain the number of children data officially from the Bureau of the Census.
Under section 2104(b)(2)(B) of the Act, the number of children for each State (provided in thousands) was determined and provided by the Bureau of the Census based on the arithmetic average of the number of low-income children and low-income children with no health insurance as calculated from the three most recent March supplements to the CPS officially available from the Bureau of the Census before the beginning of the 2004 calendar year. In particular, through December 31, 2003, the most recent official data available from the Bureau of the Census on the numbers of children were data from the three March CPSs conducted in March 2001, 2002, and 2003 (representing data for years 2000, 2001, and 2002, respectively).
The State cost factor is based on annual average wages in the health services industry in the State. The State cost factor for a State is equal to the sum of: 0.15 and 0.85 multiplied by the ratio of the annual average wages in the health industry per employee for the State to the annual wages per employee in the health industry for the 50 States and the District of Columbia.
Under section 2104(b)(3)(B) of the Act, the State cost factor for each State for a fiscal year is calculated based on the average of the annual wages for employees in the health industry for each State using data for each of the most recent three years as reported and determined as final by the BLS in the Department of Labor and available before the beginning of the calendar year in which the fiscal year begins. Therefore, the State cost factor for FY 2005 is based on the most recent 3 years of BLS data officially available as final before January 1, 2004 (the beginning of the calendar year in which FY 2005 begins); that is, the State cost factor is based on the BLS data available as final through December 31, 2003. In accordance with these requirements, we used the final State cost factor data available from BLS for 2000, 2001, and 2002 in calculating the FY 2005 final allotments.
The State cost factor is determined based on the calculation of the ratio of each State's average annual wages in the health industry to the national average
Section 2104(b)(3)(B) of the Act, as amended by the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999, refers to wage data as reported by BLS under the “Standard Industrial Classification” (SIC) system. However, in calendar year 2002, BLS phased-out the SIC wage and employment reporting system and replaced it with the “North American Industry Classification System” (NAICS). In accordance with section 2104(b)(3)(B) of the Act, for purposes of calculating the FY 2005 allotments, BLS would need to provide wage data for the 3 most recent years as available through December 31, 2003; in this case, the three years of wage data are 2000, 2001, and 2002. However, because of the change from the SIC system to NAICS, wage data for 2001 and 2002 are not available under the SIC reporting system. Wage data for 2000 under the SIC reporting system is available from BLS. Therefore, the BLS wage data used in calculating the FY 2005 SCHIP allotments necessarily reflect 1 year of SIC system data (2000) and 2 years of NAICS data (2001 and 2002) to obtain the 3-year average required for the allotments.
Under the SIC system, BLS provided CMS with wage data for each State under the SIC Code 80 for year 2000. However, the wage data codes under the SIC system do not map exactly to the wage data codes under the NAICS. As a result, for the years 2001 and 2002, BLS provided us with wage data using three NAICS wage data codes that represent approximately 98 percent of the wage data that would have been provided under the related SIC Code 80. Specifically, in lieu of SIC Code 80 data, for the years 2001 and 2002, BLS provided CMS data that are based on the following three NAICS codes: NAICS Code 621 (Ambulatory health care services), Code 622 (Hospitals), and Code 623 (Nursing and residential care facilities).
Under section 2104(b)(4) of the Act, each State and the District of Columbia is allotted a “proportion” of the total amount available nationally for allotment to the States. The term “proportion” is defined in section 2104(b)(4)(D)(i) of the Act and refers to a State's share of the total amount available for allotment for any given fiscal year. In order for the entire total amount available to be allotted to the States, the sum of the proportions for all States must exactly equal one. Under the statutory definition, a State's proportion for a fiscal year is equal to the State's allotment for the fiscal year divided by the total amount available nationally for allotment for the fiscal year. In general, a State's allotment for a fiscal year is calculated by multiplying the State's proportion for the fiscal year by the national total amount available for allotment for that fiscal year in accordance with the following formula:
In accordance with the statutory formula for determining allotments, the State proportions are determined under two steps, which are described in detail below.
Under the first step, each State's proportion is calculated by multiplying the State's Number of Children and the State Cost Factor to determine a “product” for each State. The products for all States are then summed. Finally, the product for a State is divided by the sum of the products for all States, thereby yielding the State's preadjusted proportion.
Under the second step, the preadjusted proportions are subject to the application of proportion floors, ceilings, and a reconciliation process, as appropriate. The SCHIP statute specifies three proportion floors, or minimum proportions, that apply in determining States' allotments. The first proportion floor is equal to $2,000,000 divided by the total of the amount available nationally for the fiscal year. This proportion ensures that a State's minimum allotment would be $2,000,000. For FY 2005, no State's preadjusted proportion is below this floor. The second proportion floor is equal to 90 percent of the allotment proportion for the State for the previous fiscal year; that is, a State's proportion for a fiscal year must not be lower than 10 percent below the previous fiscal year's proportion. The third proportion floor is equal to 70 percent of the allotment proportion for the State for FY 1999; that is, the proportion for a fiscal year must not be lower than 30 percent below the FY 1999 proportion.
Each State's allotment proportion for a fiscal year is also limited by a maximum ceiling amount, equal to 145 percent of the State's proportion for FY 1999, that is, a State's proportion for a fiscal year must be no higher than 45 percent above the State's proportion for FY 1999. The floors and ceilings are intended to minimize the fluctuation of State allotments from year to year and over the life of the program as compared to FY 1999. The floors and ceilings on proportions are not applicable in determining the allotments of the U.S. Territories and Commonwealths; they receive a fixed percentage specified in the statute of the total allotment available to the U.S. Territories and Commonwealths.
As determined under the first step for determining the States' preadjusted proportions, which is applied before the application of any floors or ceilings, the sum of the proportions for all the States and the District of Columbia will be equal to exactly one. However, the application of the floors and ceilings under the second step may change the proportions for certain States; that is, some States' proportions may need to be raised to the floors, while other States' proportions may need to be lowered to the maximum ceiling. If this occurs, the sum of the proportions for all States and the District of Columbia may not exactly equal one. In that case, the statute requires the proportions to be adjusted, under a method that is determined by whether the sum of the proportions is greater or less than one.
The sum of the proportions would be greater than one if the application of the floors and ceilings resulted in raising the proportions of some States (due to the application of the floors) to a greater degree than the proportions of other States were lowered (due to the application of the ceiling). If, after application of the floors and ceiling, the sum of the proportions is greater than one, the statute requires the Secretary to determine a maximum percentage increase limit, which, when applied to the State proportions, would result in the sum of the proportions being exactly one.
If, after the application of the floors and ceiling, the sum of the proportions is less than one, the statute requires the States' proportions to be increased in a “pro rata” manner so that the sum of the
The following is an explanation of how we applied the two State-related factors specified in the statute to determine the States' “preadjusted” proportions for FY 2005. The term “preadjusted,” as used here, refers to the States' proportions before the application of the floors and ceiling and adjustments, as specified in the SCHIP statute. The determination of each State and the District of Columbia's preadjusted proportion for FY 2005 is in accordance with the following formula:
The resulting proportions would then be subject to the application of the floors and ceilings specified in the SCHIP statute and reconciled, as necessary, to eliminate any deficit or surplus of the allotments because the sum of the proportions was either greater than or less than one.
Section 2104(e) of the Act requires that the amounts allotted to a State for a fiscal year be available to the State for a total of 3 years; the fiscal year for which the amounts are allotted, and the 2 following fiscal years.
Column A =
Column B =
For FY 2005, the number of children is equal to the sum of 50 percent of the number of low-income uninsured children in the State and 50 percent of the number of low-income children in the State.
Column C =
Column D =
Column E =
Column F =
Column G =
For each of the U.S. Territory and Commonwealths, the allotment is determined as the Proportion of Total in Column E multiplied by the total amount available for allotment to the U.S. Territories and Commonwealths. For the U.S. Territories and Commonwealths, the Proportion of Total in Column E is specified in section 2104(c) of the Act. The total amount is then allotted to the U.S. Territories and Commonwealths according to the percentages specified in section 2104 of the Act. There is no adjustment made to the allotments of the U.S. Territories and Commonwealths as they are not subject to the application of the floors and ceiling. As a result, Column F in the table, the Adjusted Proportion of Total, is empty for the U.S. Territories and Commonwealths.
We have examined the impact 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.
We have examined the impact of this notice as required by Executive Order 12866. Executive Order 12866 directs
The RFA requires agencies to analyze options for regulatory relief of small businesses. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and government agencies. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $6 million to $29 million in any one year. Individuals and States are not included in the definition of a small entity; therefore, this requirement does not apply.
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.
The Unfunded Mandates Reform Act of 1995 requires that agencies prepare an assessment of anticipated costs and benefits before publishing any notice that may result in an annual expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $110 million or more (adjusted each year for inflation) in any one year. Since participation in the SCHIP program on the part of States is voluntary, any payments and expenditures States make or incur on behalf of the program that are not reimbursed by the Federal government are made voluntarily. This notice will not create an unfunded mandate on States, tribal, or local governments because it merely notifies States of their SCHIP allotment for FY 2005. Therefore, we are not required to perform an assessment of the costs and benefits of this notice.
Low-income children will benefit from payments under SCHIP through increased opportunities for health insurance coverage. We believe this notice will have an overall positive impact by informing States, the District of Columbia, and U.S. Territories and Commonwealths of the extent to which they are permitted to expend funds under their child health plans using their FY 2005 allotments.
Under Executive Order 13132, we are required to adhere to certain criteria regarding Federalism. We have reviewed this notice and determined that it does not significantly affect States' rights, roles, and responsibilities because it does not set forth any new policies.
For these reasons, we are not preparing analyses for either the RFA or section 1102(b) of the Act because we have determined, and we certify, that this notice will not have a significant economic impact on a substantial number of small entities or a significant impact on the operations of a substantial number of small rural hospitals.
In accordance with the provisions of Executive Order 12866, this notice was reviewed by the Office of Management and Budget.
Centers for Medicare & Medicaid Services (CMS), HHS.
Proposed notice.
This proposed notice announces the receipt of an application from the Utilization Review Accreditation Commission for recognition as a national accreditation program for managed care organizations that wish to participate in the Medicare Advantage program. The statute requires that within 60 days of receipt of an organization's complete application, we will announce our receipt of the accreditation organization's application for approval, describe the criteria we will use in evaluating the application, and provide at least a 30-day public comment period.
To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on September 27, 2004.
In commenting, please refer to file code CMS-4067-PN. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
You may submit comments in one of three ways (no duplicates, please):
1.
2.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
(Because access to the interior of the HHH Building is not readily available to persons without Federal Government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and
Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.
For information on viewing public comments, see the beginning of the
Heidi Adams, (410) 786-1094.
This
[If you choose to comment on issues in this section, please include the caption “Background” at the beginning of your comments.]
Under the Medicare program, eligible beneficiaries may receive covered services through a managed care organization (MCO) that has a Medicare Advantage (MA) (formerly, Medicare+Choice) contract with the Centers for Medicare & Medicaid Services (CMS). The regulations specifying the Medicare requirements that must be met in order for an MCO to enter into an MA contract with CMS are located at 42 CFR part 422. These regulations implement part C of Title XVIII of the Social Security Act (the Act), which specifies the services that an MCO must provide and the requirements that the organization must meet to be an MA contractor. Other relevant sections of the Act are parts A and B of Title XVIII and part A of Title XI pertaining to the provision of services by Medicare certified providers and suppliers.
Generally, for an organization to enter into an MA contract, the organization must be licensed by the State as a risk bearing organization as set forth in part 422 of our regulations. Additionally, the organization must file an application demonstrating that it meets other Medicare requirements in part 422 of our regulations. Following approval of the contract, we engage in routine monitoring and oversight audits of the MA organization to ensure continuing compliance. The monitoring and oversight audit process is comprehensive and uses a written protocol that itemizes the Medicare requirements the MA organization must meet.
As an alternative for meeting some Medicare requirements, an MA organization may be exempt from CMS monitoring of certain requirements in subsets listed in section 1852(e)(4)(B) of the Act as a result of an MA organization's accreditation by a CMS-approved accrediting organization (AO). In essence, the Secretary “deems” that the Medicare requirements are met based on a determination that the AO's standards are at least as stringent as Medicare requirements. As we specify at § 422.157(b)(2) of our regulations, the term for which an AO may be approved by CMS may not exceed 6 years. For continuing approval, the AO will have to re-apply to CMS.
The applicant organization is generally recognized as an entity that accredits MCOs that are licensed as a health maintenance organization (HMO) or a preferred provider organization (PPO).
Section 1852(e)(4)(C) of the Act requires that within 210 days of receipt of an application, the Secretary shall determine whether the applicant meets criteria specified in section 1865(b)(2) of the Act. Under these criteria, the Secretary will consider for a national accreditation body, its requirements for accreditation, its survey procedures, its ability to provide adequate resources for conducting required surveys and supplying information for use in enforcement activities, its monitoring procedures for provider entities found out of compliance with the conditions or requirements, and its ability to provide the Secretary with necessary data for validation.
Section 1865(b)(3)(A) of the Act further requires that we publish, within 60 days of receipt of an organization's complete application, a notice identifying the national accreditation body making the request, describing the nature of the request, and providing at least a 30-day public comment period. We have 210 days from our receipt of a completed application to publish approval or denial of the application.
The purpose of this notice is to inform the public of our consideration of the Utilization Review Accreditation Commission's (URAC's) application for approval of deeming authority of MA organizations that are licensed as an HMO for the following six categories:
• Quality improvement.
• Access to services.
• Antidiscrimination.
• Information on advance directives.
• Provider participation rules.
• Confidentiality and accuracy of enrollees' records.
This notice also solicits public comment on the ability of the applicant's accreditation program to meet or exceed the Medicare requirements for which it seeks authority to deem.
On June 4, 2004, URAC submitted all the necessary information to permit us to make a determination concerning its request for approval as a deeming authority for MA organizations that are licensed as an HMO. Under § 422.158(a) of the regulations, our review and evaluation of a national accreditation organization will consider, but not necessarily be limited to, the following information and criteria:
• The equivalency of URAC's requirements for HMOs to CMS' comparable MA organization requirements.
• URAC's survey process, to determine the following:
• Detailed information about individuals who perform accreditation surveys including—
• Descriptions of the organization's—
In accordance with § 422.158(b) of our regulations, the applicant must provide documentation relating to—
• Its ability to provide data in a CMS-compatible format;
• The adequacy of personnel and other resources necessary to perform the required surveys and other activities; and
• Assurances that it will comply with ongoing responsibility requirements specified in § 422.157(c) of our regulations.
Additionally, the accrediting organization must provide CMS the opportunity to observe its accreditation process on site at a managed care organization and must provide any other information that CMS requires to prepare for an onsite visit to the AO's offices.
These site visits will help to verify that the information presented in the application is correct and to make a determination on the application.
Because of the large number of public comments we normally receive on
Upon completion of our evaluation, including evaluation of comments received as a result of this notice, we will publish a final notice in the
In accordance with the provisions of Executive Order 12866, this regulation was not reviewed by the Office of Management and Budget.
Section 1852 of the Social Security Act (42 U.S.C. 1395w-22).
Centers for Medicare & Medicaid Services (CMS), HHS.
Notice of hearing.
This notice announces an administrative hearing on October 21, 2004, at 10 a.m., 233 North Michigan Avenue,Suite 600; RE-6E Board Room; Chicago, Illinois 60601 to reconsider our decision to disapprove Minnesota State Plan Amendment (SPA) 03-06.
Requests to participate in the hearing as a party must be received by the presiding officer by September 13, 2004.
Kathleen Scully-Hayes; Presiding Officer,CMS,Lord Baltimore Drive,Mail Stop: LB-23-20,Baltimore, Maryland 21244,Telephone: 410-786-2055.
This notice announces an administrative hearing to reconsider our decision to disapprove Minnesota's Medicaid State Plan Amendment (SPA) 03-06. This SPA was submitted on March 31, 2003, with a proposed effective date of January 1, 2003. This amendment would modify the State's reimbursement methodology for nursing facility services. Specifically, it would increase a disproportionate share nursing facility add-on made to 14 of the State's county-owned nursing facilities. The Centers for Medicare & Medicaid Services (CMS) was unable to approve SPA 03-06 because the State did not document that the proposed payment methodology, in combination with funding requirements under section 4.19 D of the State's plan, meet the conditions specified in sections 1902(a)(2), 1902(a)(30)(A), and 1902(a)(19) of the Social Security Act (the Act) and are consistent with the overall Federal-state financial partnership under title XIX of the Act.
In formal requests for additional information and several subsequent discussions, CMS asked that the State describe any transfers of funds between providers and State or local governments, and indicate whether the providers kept 100 percent of the total computable funds given as Medicaid payments. The State did not provide the requested information on transfers of funds between providers and local governments, nor did it indicate that the providers keep 100 percent of the total computable funds given as Medicaid payments.
The State provided information about the flow of funds between the State and local governments and from the State to providers. However, the State did not provide information about the flow of funds from providers to the State or to local governments. This information is necessary in order to validate the funding sources of the non-Federal share of Medicaid payments and to determine the appropriateness of the payment levels. If providers refund part or all of the Medicaid payments to the State or its political subdivisions, the proposed payment rate would not reflect the net expenditure by the State, and the net non-Federal share would not meet the requirements of section 1902(a)(2) of the Act. Moreover, if such refunds are made by providers, it is an indication that the full payment amount is not required to ensure Medicaid beneficiaries access to the providers' services. The result is that payments under this section of the plan would not be in compliance with the requirement under section 1902(a)(30)(A) of the Act that payment rates must be consistent with “efficiency, economy, and quality of care.”
Since the State has not provided the necessary information regarding provider payment retention, CMS could not find that SPA 03-06 is consistent with the requirement of section 1902(a)(19) of the Act that requires that care and services will be provided consistent with “simplicity of administration and the best interests of the recipients.” The best interest of recipients is not served by a proposed payment structure that would divert Medicaid payments from the providers to the State and shift financial burdens from the State to the Federal
Moreover, absent the requested information, the State did not document whether the proposed payment methodology set forth under SPA 03-06 is consistent with the basic Federal and State financial partnership of the Medicaid program set forth by the Congress. Section 1905(b) of the Act specifies how the Federal medical assistance percentage will be calculated for states. This section clearly sets forth how the financial partnership of the Medicaid program should operate, including a definition of the required non-Federal expenditure. The requested information is necessary to determine whether the proposed payments under SPA 03-06 would accurately reflect net expenditures with a sufficient non-Federal share consistent with the Federal and State financial partnership set forth in section 1905(b) of the Act.
For these reasons, and after consultation with the Secretary as required by Federal regulations at 42 CFR 430.15, CMS disapproved this SPA.
Section 1116 of the Act and 42 CFR, part 430 establish Departmental procedures that provide an administrative hearing for reconsideration of a disapproval of a State plan or plan amendment. CMS is required to publish a copy of the notice to a state Medicaid agency that informs the agency of the time and place of the hearing and the issues to be considered. If we subsequently notify the agency of additional issues that will be considered at the hearing, we will also publish that notice.
Any individual or group that wants to participate in the hearing as a party must petition the presiding officer within 15 days after publication of this notice, in accordance with the requirements contained at 42 CFR 430.76(b)(2). Any interested person or organization that wants to participate as
The notice to Minnesota announcing an administrative hearing to reconsider the disapproval of its SPA reads as follows:
In formal requests for additional information and several subsequent discussions, CMS asked that the State describe any transfers of funds between providers and State or local governments, and indicate whether the providers keep 100 percent of the total computable funds given as Medicaid payments. The State did not provide the requested information on transfers of funds between providers and local governments, nor did it indicate that the providers keep 100 percent of the total computable funds given as Medicaid payments.
The State provided information about the flow of funds between the State and local governments and from the State to providers. However, the State did not provide information about the flow of funds from providers to the State or to local governments. This information is necessary in order to validate the funding sources of the non-Federal share of Medicaid payments and to determine the appropriateness of the payment levels. If providers refund part or all of the Medicaid payments to the State or its political subdivisions, the proposed payment rate would not reflect the net expenditure by the State, and the net non-Federal share would not meet the requirements of section 1902(a)(2) of the Act. Moreover, if such refunds are made by providers, it is an indication that the full payment amount is not required to ensure Medicaid beneficiaries access to the providers' services. The result is that payments under this section of the plan would not be in compliance with the requirement under section 1902(a)(30)(A) of the Act that payment rates must be consistent with “efficiency, economy, and quality of care.”
Since the State did not provide the necessary information regarding provider payment retention, CMS could not find that SPA 03-06 is consistent with the requirement of section 1902(a)(19) of the Act that care and services are consistent with “simplicity of administration and the best interests of the recipients.” The best interest of recipients is not served by a proposed payment structure that would divert Medicaid payments from the providers to the State and shift financial burdens from the State to the Federal Government. The best interest of recipients requires that the full amount of Medicaid payments are available to support access to quality care and services. Furthermore, SPA 03-06 is not consistent with the requirements for a State plan that are set forth in the regulations implementing section 1902(a) of the Act. Under 42 CFR 430.10, the State plan must contain all the information necessary for CMS to determine whether the plan can serve as a basis for Federal financial participation (FFP) that would be available under section 1903(a)(1) of the Act. CMS cannot determine whether the proposed plan amendment sets forth a payment methodology that could be a basis for FFP without information about whether providers refund payments and, if so, whether these refunds are offset against expenditures as an applicable credit.
Moreover, absent the requested information, the State did not document whether the proposed payment methodology set forth under SPA 03-06 is consistent with the basic Federal and State financial partnership of the Medicaid program set forth by the Congress. Section 1905(b) of the Act specifies how the Federal medical assistance percentage will be calculated for states. This section clearly sets forth how the financial partnership of the Medicaid program should operate, including a definition of the required non-Federal expenditure. The requested information is necessary to determine whether the proposed payments under SPA 03-06 would accurately reflect net expenditures with a sufficient non-Federal share consistent with the Federal and State financial partnership set forth in section 1905(b) of the Act.
For these reasons, and after consultation with the Secretary as required by 42 CFR 430.15(c)(2), CMS disapproved Minnesota SPA 03-06.
I am scheduling a hearing on your request for reconsideration to be held on October 21, 2004, at 10 a.m., at 233 North Michigan Avenue, Suite 600, RE-6E Board Room, Chicago, Illinois 60601. If this date is not acceptable, we would be glad to set another date that is mutually agreeable to the parties. The hearing will be governed by the procedures prescribed at 42 CFR, part 430.
I am designating Ms. Kathleen Scully-Hayes as the presiding officer. If these
Sincerely,
Centers for Medicare & Medicaid Services (CMS), HHS.
Notice.
This notice announces the annual update to the hospice wage index as required by statute. This fiscal year 2005 update is effective from October 1, 2004 through September 30, 2005. The wage index is used to reflect local differences in wage levels. The hospice wage index methodology and values are based on recommendations of a negotiated rulemaking advisory committee and were originally published in the August 8, 1997
October 1, 2004.
Terri Deutsch, (410) 786-9462.
Hospice care is an approach to treatment that recognizes that the impending death of an individual warrants a change in the focus from curative care to palliative care (relief of pain and other uncomfortable symptoms). The goal of hospice care is to help terminally ill individuals continue life with minimal disruption to normal activities while remaining primarily in the home environment. A hospice uses an interdisciplinary approach to deliver medical, social, psychological, emotional, and spiritual services through use of a broad spectrum of professional and other caregivers, with the goal of making the individual as physically and emotionally comfortable as possible. Counseling and inpatient respite services are available to the family of the hospice patient. Hospice programs consider both the patient and the family as a unit of care.
Section 1861(dd) of the Social Security Act (the Act) provides for coverage of hospice care for terminally ill Medicare beneficiaries who elect to receive care from a participating hospice. The statutory authority for payment to hospices participating in the Medicare program is contained in section 1814(i) of the Act.
Our existing regulations under 42 CFR part 418 establish eligibility requirements and payment standards and procedures, define covered services, and delineate the conditions a hospice must meet to be approved for participation in the Medicare program. Subpart G of part 418 provides for payment to hospices based on one of four prospectively determined rates for each day in which a qualified Medicare beneficiary is under the care of a hospice. The four rate categories are routine home care, continuous home care, inpatient respite care, and general inpatient care. Payment rates are established for each category.
The regulations at § 418.306(c), which require the rates to be adjusted by a wage index, were revised in the August 8, 1997 final rule (62 FR 42860). This rule implemented a new methodology for calculating the hospice wage index based on the recommendations of a negotiated rulemaking committee. The committee reached consensus on the methodology. We included the resulting committee statement, describing that consensus, as an appendix to the August 8, 1997 final rule (62 FR 42883). The provisions of the final hospice wage index rule are as follows:
• The revised hospice wage index will be calculated using the most current available hospital wage data.
• The revised hospice wage index was phased in over a 3-year transition period.
For the first year of the transition period, October 1, 1997 through September 30, 1998, a blended index was calculated by adding two-thirds of the 1983 index value for an area to one-third of the revised wage index value for that area. During the second year of the transition period, October 1, 1998 through September 30, 1999, the calculation was similar, except that the blend was one-third of the 1983 index value and two-thirds of the revised wage index value for that area. We fully implemented the revised wage index during the third year of the transition period,October 1, 1999 through September 30, 2000.
Payments to hospices under the wage index (as published in the August 8, 1997 final hospice wage index rule) are subject to a budget-neutrality adjustment to ensure that aggregate adjustments to payment using the new wage index, irrespective of other payment adjustments, are not greater than they would have been had the original 1983 wage index been applied. To achieve this budget neutrality, the hospice wage index is multiplied by a budget-neutrality factor. The budget-neutrality factor is computed and applied annually. The hospice budget-neutrality adjustment is not applied uniformly to all providers in calculating payments. Based on the methodology developed and signed by the negotiated rulemaking committee and adopted by CMS, a hospice's area wage index is adjusted using either the budget-neutrality factor or the hospice wage index floor described below.
Hospice wage index values of 0.8 or greater are multiplied by the budget-neutrality factor.
Hospice wage index values below 0.8 are adjusted by the greater of: (1) The hospice budget-neutrality factor; or (2) the hospice wage index floor (a 15 percent increase, subject to a maximum wage index value of 0.8).
The wage index is to be updated annually, in the
Section 4441(a) of the Balanced Budget Act of 1997 (BBA) amended
This annual update is effective October 1, 2004 through September 30, 2005. In accordance with the agreement we signed with other members of the Hospice Wage Index Negotiated Rulemaking Committee, we are using the most current hospital data available to us. The FY 2004 hospital wage index was the most current hospital wage data available when the FY 2005 wage index values were calculated. We used the pre-reclassified and pre-floor hospital area wage index data.
All wage index values are adjusted by a budget-neutrality factor of 1.065819 and are subject to the wage index floor adjustment, if applicable. We have completed all of the calculations described above and have included them in the wage index values reflected in both Tables A and B below. A detailed description of the method used to compute the hospice wage index is contained in both the September 4, 1996 proposed rule (61 FR 46579) and the August 8, 1997 final rule (62 FR 42860).
Under the Administrative Procedure Act (5 U.S.C. section (553(b)(B)), we may waive notice and comment rulemaking procedures if we find good cause to do so (that is, notice and comment procedures are impracticable, unnecessary, or contrary to the public interest) and the agency incorporates a statement of the finding and the reasons for waiver in the notice issued. We are waiving notice and comment rulemaking before the provisions of this notice take effect.
We find it unnecessary to undertake notice and comment rulemaking because the methodologies used to determine the hospice wage index have been previously subjected to public comments, and this notice merely reflects the application of those previously established methodologies. In this notice, we are not changing the methodologies, but merely performing the ministerial function of applying methodologies previously subject to notice and public comment. Therefore, we believe it is unnecessary to engage in notice and comment rulemaking and, for good cause, we waive notice and comment procedures.
We also believe that good cause exists to waive notice and comment rulemaking because it is in the public interest to make this notice effective on October 1, 2004. The statute in 1814(i)(1)(C)(ii)(VII) of the Act requires annual updates to the hospice payment rates and wage indices. In addition, the Federal Regulations at 42 CFR 418.306(b)(2) and (c) require annual updates to hospice wage indices and require that such updates be effective for the FY, beginning on October 1. We do not have sufficient time to engage in notice and comment rulemaking before that date. Moreover, if we do not make this notice effective on the implementation date of October 1, 2004, the hospice agencies would be required to continue to use the previous 2004 FY wage index for the 2005 payment rates.
Therefore, for the reasons stated above, we find there is good cause to waive notice and comment procedures of the Administrative Procedure Act.
We have examined the impacts of this notice as required by Executive Order 12866 (September 1993, Regulatory Planning and Review), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Act, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132. In this notice, we identified the impact on hospices as a result of updating the hospice wage index. The methodology for computing the wage index for FY 2005 was determined through a negotiated rulemaking committee and implemented in the August 8, 1997 final rule (62 FR 42860). This notice only updates the hospice wage index in accordance with that methodology. We believe these changes to be insignificant. As Table C below indicates, we estimate that the total hospice payments will increase from last year by 1.0 percent, or $60,113,000. We have compared estimated payments using the FY 1983 hospice wage index to estimated payments using the FY 2005 wage index and determined the current hospice wage index to be budget neutral. Budget neutrality means that, in a given year, estimated aggregate payments for Medicare hospice services using the FY 2005 Wage Index will equal estimated aggregate payments that would have been made for the same services if the 1983 wage index had remained in effect. Budget neutrality to 1983 does not imply that estimated payments will not increase since the budget neutrality applies only to the wage index portion and not the total payment rate, which accommodates inflation.
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 ($100 million or more in any 1 year). We have determined that this notice is not an economically significant rule under this Executive Order.
The RFA requires agencies to analyze options for regulatory relief of small businesses. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and government agencies. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $6 million to $29 million in any 1 year (for details, see the Small Business Administration's regulation at 65 FR 69432, that sets forth size standards for health care industries). For purposes of the RFA, most hospices are small entities. As indicated in Table C below, there are 2,385 hospices. Approximately 70 percent of Medicare certified hospices are identified as voluntary, government, or other agencies, and, therefore, are considered small entities. Because the National Hospice and Palliative Care Organization estimates that approximately 79 percent of hospice patients are Medicare beneficiaries, we have not considered other sources of revenue in this analysis.
As discussed below, rural hospices will receive an increase in payment that is greater than urban hospices. Overall rural hospices will receive an increase of 2.9 percent and urban hospices will receive an increase of 0.7 percent. All hospices, both urban and rural, will receive a 1.0 percent increase in payment representing an increase of $60,113,000. Urban hospices in East North Central and Puerto Rico regions will experience a decrease of 0.2 percent and 0.3 percent respectively. New England and Puerto Rico rural regions will also experience a decrease of 0.5 and 4.1 percent respectively. Of the urban hospices, the West South Central
Under the Medicare hospice benefit, hospices can provide four different levels of care days. The majority of the days provided by a hospice are routine home care days. Therefore, the number of routine home care days can be used as a proxy for the size of the hospice, that is, the more days of care provided, the larger the hospice. Using routine home care days as a proxy for size, our analysis indicates that the impact of the wage index update on small hospices (those that provide up to 1,754 days of routine home care) will experience a 10.2 percent increase. Rural Puerto Rico with 4 hospices and 150,000 routine care days will experience a decrease of 4.1 percent while rural East South Central with 111 hospices and 1,541,000 routine home care days, which represents the highest number of routine home days, will have an increase of 6.5 percent. Rural South Atlantic and East North Central, each with 139 hospices and 1,390 and 924,000 routine home care days, respectively, will experience an increase of 2.3 percent and 1.4 percent, respectively. Rural New England region with 27 hospices and the lowest number of routine home care days of 111,000 will experience a 0.5 percent decrease.
Furthermore, the wage index methodology was previously determined by consensus, through a negotiated rulemaking committee that included representatives of national hospice associations; rural, urban, large and small hospices; multi-site hospices; and consumer groups. Based on all of the options considered, the committee agreed on the methodology described in the committee statement, and it was adopted into regulation in the August 8, 1997 final rule. The committee also agreed that this was favorable for the hospice community, as well as for beneficiaries. In developing the process for updating the wage index in the 1997 final rule, we fully considered the impact of this methodology on small entities and attempted to mitigate any potential negative effects.
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 an MSA and has fewer than 100 beds.
Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule that may result in an expenditure in any 1 year by State, local, and tribal governments, in the aggregate, or by the private sector, of $110 million or more. This notice has no substantial effect on State, local or tribal governments or on the private sector. We have determined that this notice will not have a significant impact on the operations of a substantial number of small rural hospitals.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. We have reviewed this notice under the threshold criteria of Executive Order 13132, Federalism, and have determined that this notice will not have an impact on the rights, roles, and responsibilities of State, local, or tribal governments.
We have compared estimated payments using the FY 1983 hospice wage index to estimated payments using the FY 2005 wage index and determined the current hospice wage index to be budget neutral. This impact analysis compares hospice payments using the FY 2004 hospice wage index to the estimated payments using the FY 2005 wage index. The data used in developing the quantitative analysis for this notice were obtained from the March 2004 update of the national claims history file of all bills submitted during FY 2003. We deleted bills from hospices that have since closed.
Table C below demonstrates the results of our analysis. In column 2 of Table C, we indicate the number of routine home care days that were included in our analysis, although the analysis was performed on all types of hospice care. Column 3 of Table C indicates payments that were made using the FY 2004 wage index. Column 4 of Table C is based on FY 2004 claims (for hospices in business during that time period) and estimates payments to be made to hospices using the FY 2005 wage index. The final column, which compares columns 3 and 4, shows the percent change in estimated hospice payments made based on the category of the hospice.
Table C categorizes hospices by various geographic and provider characteristics. The first row displays the results of the impact analysis for all Medicare certified hospices. The second and third rows of the table categorize hospices according to their geographic location (urban and rural). Our analysis indicted that there are 1,469 hospices located in urban areas and 916 hospices located in rural areas. The next two groupings in the table indicate the number of hospices by census region, also broken down by urban and rural hospices. The sixth grouping shows the impact on hospices based on the size of the hospice's program. We determined that the majority of hospice payments are made at the routine home care rate. Therefore, we based the size of each individual hospice's program on the number of routine home care days
The results of our analysis shows that the majority of hospices are in urban areas and provide the vast majority of routine home care days. However, rural hospices will receive a larger percent increase in payment of 2.9 percent in contrast to 0.7 percent for urban hospices.
The greatest increases in payment are for rural East South Central and West North Central regions with a 6.5 percent and 4.0 percent increase, respectively. Four regions will experience a decrease in payment with the greatest decrease in payment for rural Puerto Rico with a 4.1 percent decrease followed by rural New England, urban Puerto Rico, and urban East North Central regions with 0.5 percent, 0.3 percent, and 0.2 percent decreases, respectively. The remainder of the urban areas varies from an increase of 0.3 percent in the Middle Atlantic region to an increase of 1.8 percent in the Mountain region.
The breakdown by size indicates an increase of 10.2 percent in payment for hospices with routine home care days under 1,754 followed by a 4.5 percent increase in moderate size hospices with 1,754 to 4,373 days and an increase of 0.8 percent for large size hospitals.
Proprietary-owned hospices will experience the highest increase of 1.4 percent while voluntary owned hospices with the largest number of routine home care days will receive 0.8 percent increase in payment.
Freestanding agency based hospices with the highest number of routine home care days and with the largest number of hospice agencies will have the highest increase of a 1.1 percent payment increase. In contrast, skilled nursing facility based hospices will have an increase of 0.3 percent, which represents the lowest number of routine home care days.
Our impact analysis compared hospice payments by using the FY 2004 wage index to the estimated payments using the FY 2005 wage index. Through the analysis, we estimate that total hospice payments will increase from last year by 1.0 percent or by $60,113,000. Additionally, we compared estimated payments using the FY 1983 hospice wage index to estimated payments using the FY 2005 wage index and determined the current hospice wage index to be budget neutral, as required by the negotiated rulemaking committee. We have determined that this rule is not an economically significant rule under Executive Order 12866. Although we believe that this rule will not have a significant economic impact on a substantial number of small entities, we took any negative effects into consideration during the negotiated rulemaking process. We have determined that this notice will not have a significant impact on the operations of a substantial number of small rural hospitals. Finally, this notice will not have a consequential effect on State, local, or tribal governments.
In accordance with the provisions of Executive Order 12866, the Office of Management and Budget reviewed this notice.
Section 1814(i) of the Social Security Act (42 U.S.C. 1395f (i)(1))
Centers for Medicare & Medicaid Services (CMS), HHS.
Notice; correction.
This document corrects technical and typographical errors that appeared in the notice published in the
Effective June 29, 2004.
Jody Blatt, (410) 786-6921.
In FR Doc. 04-14673 of June 29, 2004 (69 FR 38898), there were a number of technical and typographical errors that are identified and corrected in the Correction of Errors section below. The provisions in this correction notice are effective as if they were included in the document published June 29, 2004. Accordingly, the corrections are effective June 29, 2004.
In FR Doc. 04-14673 of June 29, 2004 (69 FR 38898), make the following corrections:
1. On page 38899, in the table, in the first column, the term entitled “Chronic Myelogenous Lymphoma” is corrected to read “Chronic Myelogenous Leukemia.”
2. On page 38899, in the table, in the first column, the term entitled “Anaplastic astrocytoma” is removed. Temodar, which treats anaplastic astrocytoma, is already covered under Medicare Part B and will not be covered under this demonstration.
3. On page 38899, in the table, in the second column, the drug entitled “Pegalated interferon alfa-2a (PEG-Intron)” is corrected to read “Pegylated interferon alfa-2b (PEG-Intron).”
4. On page 38899, in the table, in the second column the drug entitled “Temozolomide (Temodar)” is removed. Temodar is already covered under Medicare Part B and will not be covered under this demonstration.
5. On page 38900, in the first column, in the fourth paragraph, in the seventh and eighth lines, the words “Advance PCS, a Caremark Company (Caremark),” are corrected to read “Caremark.” The correct reference to this company is Caremark, not Advance PCS, a Caremark Company.
6. On page 38902, in the third column, in the first through eighth lines, remove the sentence “The rules for low-income assistance, including coverage levels and determination of eligibility, have been established to be consistent with what will be in effect in 2006 when the Medicare Part D drug benefit is implemented.” Rules established for this demonstration apply only to this demonstration and do not necessarily reflect how the Medicare Part D benefit will be implemented.
7. On page 38903, in Table 1A, the following sentence is added to the footnote, “Under the different low income benefit levels, subsidies by Medicare as well as out-of-pocket payments by the beneficiary count towards the out-of-pocket catastrophic limit.”
8. On page 38904, in Table 1B, in the second column, under the heading entitled “Benefit Level 1 (Standard),” in the third row, the amount “$1,350” is corrected to read “$2,850.”
9. On page 38904, in Table 1B, the following sentence is added to the footnote, “Under the different low income benefit levels, subsidies by Medicare as well as out-of-pocket payments by the beneficiary count towards the out-of-pocket catastrophic limit.”
We ordinarily publish a notice of proposed rulemaking in the
We find it unnecessary to undertake notice and comment rulemaking because this notice merely provides technical corrections to the notice.
Centers for Medicare & Medicaid Services (CMS), HHS.
Notice.
This notice announces a public meeting of the Medicare Coverage Advisory Committee (MCAC). The Committee provides advice and recommendations about whether scientific evidence is adequate to determine whether certain medical items and services are reasonable and necessary under the Medicare statute. This meeting concerns the use of portable multichannel home sleep testing devices as an alternative to facility-based polysomnography in the evaluation of obstructive sleep apnea. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).
The public meeting will be held on Tuesday, September 28, 2004 from 7:30 a.m. until 3:30 p.m. e.s.t.
The meeting will be held at the Holiday Inn Inner Harbor, 301 West Lombard Street, Baltimore, MD 21201.
Janet A. Anderson, Executive Secretary, by telephone at (410) 786-2700 or by e-mail at
On December 14, 1998, we published a notice in the
After the public and CMS presentations, the Committee will deliberate openly on the topic. Interested persons may observe the deliberations, but the Committee will not hear further comments during this time except at the request of the chairperson. The Committee will also allow a 15 minute unscheduled open public session for any attendee to address issues specific to the topic. At the conclusion of the day, the members will vote and the Committee will make its recommendation.
5 U.S.C. App. 2, section 10(a).
Centers for Medicare & Medicaid Services (CMS), HHS.
Notice of meeting.
This notice announces the date, location, and registration requirements for the first public meeting of the Program Advisory and Oversight Committee (PAOC) for the competitive acquisition of certain durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). The October 6, 2004 meeting will provide a forum for the PAOC to consider issues related to competitive bidding for DMEPOS items and to furnish advice to the Secretary regarding these issues. Requirements for the PAOC are specified by section 302 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173). The public is invited to attend this meeting to observe the committee's discussion. While non-committee members attending the meeting as interested observers will not have the opportunity to make oral comments or presentations, written comments will be accepted.
The PAOC meeting will be held in the Centers for Medicare & Medicaid Services (CMS) Auditorium. Our address is 7500 Security Boulevard, Baltimore, MD 21244.
Sean Dalenberg, (410) 786-0300.
On December 8, 2003, the President signed the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-173). Section 302 of MMA requires the Secretary of the Department of Health and Human Services (the Secretary) to replace the current DME payment methodology for certain items with a competitive acquisition process to improve the effectiveness of Medicare's methodology for setting DME payment amounts. The new bidding process will establish payment for DME, and drugs and supplies used in conjunction with DME, but excluding inhalation drugs and class III devices under the Food, Drug and Cosmetic Act. In addition, this new bidding process will establish payment for enteral nutrition and off-the-shelf orthotics. Section 302 of MMA also mandates implementation of an accreditation program and development of quality standards for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). The statute requires the Secretary to establish the PAOC. The PAOC is responsible for providing advice on the development and implementation of these provisions.
Specifically, section 302 of the MMA states that the PAOC shall provide advice on the following:
• Implementation of the Competitive Acquisition Program.
• Establishment of financial standards for suppliers under the program that take into account the needs of small providers.
• Establishment of data collection requirements for the efficient management of the program.
• Development of proposals for efficient interaction among manufacturers, providers of services, suppliers, and individuals.
• Establishment of the quality standards.
The PAOC may also perform additional functions specified by the Secretary. As specified in section 302(b)(1) of MMA, which amends section 1847 of the Act by adding paragraph (c)(4), to specify that the provisions of the Federal Advisory Committee Act (5 U.S.C. App.) are not applicable for PAOC meetings.
On June 2, 2004, we published a notice in the
Each registrant must provide the following information: Name; company name and address (if applicable); telephone and fax numbers; e-mail address (if available); and any special needs requirements. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
A CMS staff member will confirm your registration by mail, e-mail or fax. We recommend that you retain a copy of this confirmation of pre-registration to facilitate your entry into the building.
Written comments from the public addressing topics discussed at the meeting must be received by October 13, 2004. Please send your written comments to Sean Dalenberg, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Mail Stop C5-08-27, Baltimore, MD 21244. A summary of the public meeting will be posted at
This PAOC public meeting will be held in a Federal government building; therefore, Federal security measures are in effect. In planning your arrival, we recommend allowing additional time to clear security. In order to gain access to the building and grounds, all attendees
Section 302 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173).
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a collection of information entitled “Focus Groups as Used by the Food and Drug Administration” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Jonna Capezzuto, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.
In the
In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to OMB under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, call the HRSA Reports Clearance Officer on (301) 443-1129.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Congress legislated FTCA medical malpractice protection for free clinic volunteer health professionals through Section 194 of the Health Insurance Portability and Accountability Act (HIPAA) amending Section 224 of the Public Health Service Act. Individuals eligible to participate in this program are health care practitioners volunteering at free clinics who meet specific eligibility requirements. If an individual meets all the requirements of this program they can be “deemed” to be a Federal employee. This deemed status is specifically to provide immunity from medical malpractice lawsuits as a result of the performance of medical, surgical, dental, or related activities within the scope of the volunteer's work at the free clinic.
The sponsoring free clinic entity must submit an application to the Health Resources and Services Administration (HRSA). This application will require information about the sponsoring free clinic's credentialing system, risk management practices, and quality assurance system in order to ensure the Government is not exposed to undue liability resulting from the medical malpractice coverage of non-qualified health care professionals. Attached to the application will be a listing of specific health care providers for whom the sponsoring free clinic is requesting deemed status.
Send comments to Susan G. Queen, Ph.D., HRSA Reports Clearance Officer, Room 14-33, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. Written comments should be received within 60 days of this notice.
Bureau of Customs and Border Protection, U.S. Department of Homeland Security.
General Notice.
Pursuant to section 641 of the Tariff Act of 1930, as amended, (19 U.S.C. 1641) and the Customs Regulations (19 CFR 111.51), the following Customs broker local permits are canceled without prejudice.
Bureau of Customs and Border Protection, U.S. Department of Homeland Security.
General Notice.
Pursuant to section 641 of the Tariff Act of 1930, as amended, (19 U.S.C. 1641) and the Customs Regulations (19 CFR 111.51), the following Customs broker licenses are canceled without prejudice.
Bureau of Customs and Border Protection, U.S. Department of Homeland Security.
General Notice.
Pursuant to section 641 of the Tariff Act of 1930, as amended, (19 U.S.C. 1641) and the Customs Regulations (19 CFR 111.51), the following Customs broker national permits are canceled without prejudice.
Customs and Border Protection, Homeland Security.
Proposed interpretive rule; solicitation of comments.
This document concerns the proper classification under the Harmonized Tariff Schedule of the United States (HTSUS) of baseball-style caps featuring ornamental braid located between peak and crown. The specific issue presented is how wide must ornamental braid be on a baseball-style cap to be classified in the HTSUS as either “wholly or in part of braid” rather than “not in part of braid.” In an effort to achieve uniformity in the classification of this commodity, Customs and Border Protection (CBP) is proposing that ornamental braid on a baseball-style cap, located between peak and crown, in a width of
Comments must be received on or before October 26, 2004.
Written comments (preferably in triplicate) may be submitted to U.S. Customs and Border Protection, Office of Regulations & Rulings, Attention: Regulations Branch, 1300 Pennsylvania Avenue NW., Washington, DC 20229. Submitted comments may be inspected at Customs and Border Protection, 799 9th Street, NW., Washington, DC, during regular business hours. Arrangements to inspect submitted comments should be made in advance by calling Mr. Joseph Clark at (202) 572-8768.
Teresa Frazier, U.S. Customs and Border Protection, Office of Regulations & Rulings, Textiles Branch, (202) 572-8821.
Baseball-style caps are classifiable in heading 6505 of the Harmonized Tariff Schedule of the United States (HTSUS) which provides for, in pertinent part, “hats and other headgear, knitted or crocheted, or made up from lace, felt or other textile fabric, in the piece (but not in strips), whether or not lined or trimmed; * * *.” Within heading 6505, HTSUS, two subheadings differentiate between hats and other headgear that are “wholly or in part of braid” and those that are “not in part of braid.”
In cases where baseball-style caps feature ornamental braid located between the peak and crown, the determinative issue is whether the braid impacts classification at the subheading level so as to render the cap classifiable as either “in part of braid” or “not in part of braid.” The 2003 HTSUS defines the term “in part of” in General Note 22. General Note 22(e)(ii), HTSUS, provides that “in part of” or “containing” means that the goods contain a significant quantity of the named material and that “with regard to the application of the quantitative concepts specified above, it is intended that the
The
Certain amounts of an ingredient, although substantial, may be ignored for classification purposes, depending upon many different circumstances, including the purpose which Congress sought to bring about by the language used and whether or not the amount used has really changed or affected the nature of the article, and of course, its salability.
In a prior application of the
After the issuance of these rulings, CBP published a proposed interpretive rule in the
CBP did not publish a final interpretive rule on this issue. Since publication of the proposed interpretive rule in 1991, CBP has issued inconsistent classification rulings on merchandise featuring ornamental braid of various widths. In this regard, it is noted that several of these rulings adopted a
CBP is soliciting public comment as to the appropriateness of the proposed threshold width.
CBP will consider written comments timely submitted in its review of the proposed width (
The principal author of this document was Ms. Suzanne Kingsbury, Office of Regulations and Rulings, U.S. Customs and Border Protection. However, personnel from other offices participated in its development.
Federal Emergency Management Agency, Emergency Preparedness and Response Directorate, Department of Homeland Security.
Notice.
This notice amends the notice of a major disaster declaration for the State of Florida (FEMA-1539-DR), dated August 13, 2004, and related determinations.
Effective August 19, 2004.
Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472, (202) 646-2705.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Under Secretary for Emergency Preparedness and Response, Department of Homeland Security, under Executive Order 12148, as amended, William L. Carwile, III, of FEMA is appointed to act as the Federal Coordinating Officer for this declared disaster.
This action terminates my appointment of Michael E. Bolch as Federal Coordinating Officer for this disaster.
Federal Emergency Management Agency, Emergency Preparedness and Response Directorate, Department of Homeland Security.
Notice.
This notice amends the notice of a major disaster declaration for the State of Kansas (FEMA-1535-DR), dated August 3, 2004, and related determinations.
Effective August 18, 2004.
Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472, (202) 646-2705.
The notice of a major disaster declaration for the State of Kansas 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 August 3, 2004:
Rooks and Woodson Counties for Public Assistance.
Federal Emergency Management Agency, Emergency Preparedness and Response Directorate, Department of Homeland Security.
Notice.
This notice amends the notice of a major disaster declaration for the Commonwealth of Kentucky (FEMA-1537-DR), dated August 6, 2004, and related determinations.
Effective August 19, 2004.
Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472, (202) 646-2705.
The notice of a major disaster declaration for the Commonwealth of Kentucky is hereby amended to include the following area among those areas determined to have been adversely affected by the catastrophe declared a major disaster by the President in his declaration of August 6, 2004:
Federal Emergency Management Agency, Emergency Preparedness and Response Directorate, Department of Homeland Security.
Notice.
This notice amends the notice of a major disaster declaration for the State of New York (FEMA-1534-DR), dated August 3, 2004, and related determinations.
Effective August 18, 2004.
Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472, (202) 646-2705.
The notice of a major disaster declaration for the State of New York 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 August 3, 2004:
Federal Emergency Management Agency, Emergency Preparedness and Response Directorate, Department of Homeland Security.
Notice.
This notice amends the notice of a major disaster declaration for the State of West Virginia (FEMA-1536-DR), dated August 6, 2004, and related determinations.
Effective August 19, 2004.
Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472, (202) 646-2705.
The notice of a major disaster declaration for the State of West Virginia 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 August 6, 2004:
Fish and Wildlife Service, Interior.
Notice of availability of EIS/EIR and public meeting.
The U.S. Fish and Wildlife Service and the California Department of Fish and Game are proposing to restore to tidal action 1,400 acres of former salt ponds on Bair Island, Don Edwards San Francisco Bay National Wildlife Refuge and the Bair Island State Ecological Reserve in South San Francisco Bay.
A Draft Environmental Impact Statement/Environmental Impact Report (EIS/EIR) has been prepared jointly by the Service and the California Department of Fish and Game to analyze the impacts of the restoration plan and is available for public review. All comments received, including names and addresses, will become part of the official administrative record and may be made available to the public. The analyses provided in the Draft EIS/EIR are intended to inform the public of our proposed action, alternatives, and associated impacts; address public comments received during the scoping period for the Draft EIS/EIR; disclose the direct, indirect, and cumulative environmental effects of the proposed action and each of the alternatives; and indicate any irreversible commitment of resources that would result from implementation of the proposed action. A public meeting will be held in Redwood City, California.
A public meeting to solicit comments on the Draft Environmental
We will accept public comments until at least 45 days after the Environmental Protection Agency (EPA) publishes its corresponding notice, which sets the public comment deadline for our EIS. In accordance with NEPA, we have filed the EIS with EPA. Each Friday, EPA publishes a
Public meeting location will be at the Veteran's Memorial Senior Center, 1455 Madison Ave., Redwood City, California 94061.
Send comments to Refuge Manager, U.S. Fish and Wildlife Service, San Francisco Bay NWR Complex, P.O. Box 524, Newark, California 94560. Written comments may be sent by facsimile to (510) 792-5828 or by e-mail to
Questions regarding the Federal National Environmental Policy Act (NEPA) process may be directed to Clyde Morris, Refuge Manager, Don Edwards San Francisco Bay NWR, at the above address; telephone (510) 792-0222.
Individuals wishing copies of the Draft Environmental Impact Statement should contact the Service by letter, facsimile or e-mail to the Don Edwards San Francisco Bay National Wildlife Refuge (see
The Bair Island Complex is divided into three distinct areas separated by slough channels: Inner, Middle, and Outer Bair. Inner Bair Island is connected to the mainland with access from Whipple Avenue and U.S. Highway 101. Inner Bair Island is separated from Middle Bair by Smith Slough, which in turn is separated from Outer Bair by Corkscrew Slough.
Historically, Bair Island was part of a large complex of tidal marshes and mud flats within the drainage of San Francisco Bay, Redwood Creek and Steinberger Slough. Bair Island was diked in the late 1800's and early 1900's for agricultural purposes. It was converted to commercial salt ponds in 1946 and remained in production until 1965. The lands were then drained and sold to a series of real estate development companies. A local referendum in the City of Redwood City halted development plans for Bair Island. The California Department of Fish and Game (CDFG) and the Don Edwards San Francisco Bay National Wildlife Refuge (Refuge) both acquired portions of Bair Island over time. The Peninsula Open Space Trust purchased the majority of the remaining portions of Bair Island in 1999 and their interests were acquired by these agencies. Among several other landowners still remaining on Bair Island, the San Carlos Airport retains a portion of Inner Bair Island as a flight safety zone. In addition, two easements exist on Bair Island, for the Pacific Gas and Electric transmission towers and lines that run throughout the site and for the South Bayside System Authority (SBSA) force main that runs underneath most of the southern part of the levee on Inner Bair Island. Pedestrians and bicyclist currently use the top of the Inner Bair Island levee as a three-mile loop trail with a
The goal of the proposed Bair Island Restoration and Management Plan is to restore Bair Island to a tidal salt marsh to provide habitat for endangered species and other native wildlife as well as to enhance the public's appreciation and awareness of the unique resources at Bair Island. Once restored, the site will assist with the preservation and recovery of both the California clapper rail and the salt marsh harvest mouse. These two species were listed by the Fish and Wildlife Service as endangered species on October 13, 1970.
Under the No Action alternative, the Refuge would discontinue on-going levee maintenance and would not repair any levee breaks. The Refuge would work with the San Carlos Airport and the SBSA to protect their infrastructure on Inner Bair Island.
The existing levees on Middle and Outer Bair Island would eventually breach causing unmanaged tidal inundation of the ponds. This would result in several impacts to existing infrastructure. There would be an increase in the sedimentation rate of the Redwood Creek Shipping Channel resulting in the need for more frequent dredging by the Port of Redwood City. At least in the short-term, there would be an increase in the velocity rate of the tidal waters at the junction of Smith Slough and Redwood Creek making use of the Pete's Harbor Marina more difficult. Ponding of water on Inner Bair Island would increase the bird strike issue for the San Carlos Airport. Approximately 1,400 acres of tidal salt marsh would eventually be restored but the No Action Alternative would delay restoration of the ponds to salt marsh by 20-100 years and, at least in the short term, result in poorer quality endangered species habitat being developed compared to the four action alternatives.
In the short-term (approximately five years), the No Action alternative would provide limited public use consistent with protection of wildlife habitat and public safety. In the long term (approximately five to ten years), as the Inner Bair Island levee became unsafe, public use of the 3-mile trail would be eliminated and the area would be closed to public access. No additional public use infrastructure such as wildlife viewing platforms and interpretive signage would be installed and the Bair Island parking lot would be closed.
In Alterative 1, the Tidal Marsh Restoration with Moderate Public Access Alternative, full tidal salt marsh restoration would occur on Outer,
A wildlife viewing platform with portage for small boats would be constructed at the flow restrictor in Corkscrew Slough. A 5 mph speed limit and no wake zone would be implemented in Smith and Corkscrew Slough to protect harbor seals and other sensitive wildlife. In addition to waterfowl hunting, Refuge guided trips would continue to be the only public access allowed on Outer and Middle Bair Island. On Inner Bair Island, 2.7 miles trails on the levee which would end at wildlife platforms adjacent to Smith Slough would replace the 3-mile loop trail. Pets (dogs only) would be allowed on the Inner Bair Island trails on a 6-foot leash for a test period to determine compliance with Refuge regulations designed to protect wildlife.
Alternative 2, the Tidal Marsh Restoration with Restricted Public Access Alternative, would be the same as the Preferred Alternative (Alternative 1) except for the following: (1) No pets would be allowed on Inner Bair Island and the public access trail would be reduced to 1.8 miles on the levee to the north ending in one wildlife viewing platform on Smith Slough, and (2) there would be a seasonal closure to boating in Corkscrew Slough to protect harbor seals. Approximately 1,400 acres of tidal salt marsh would be restored more quickly that the No Action Alternative for the endangered California clapper rail, salt marsh harvest mouse and other native wildlife.
Alternative 3, the Tidal and Managed Marsh Restoration with Moderate Public Access Alternative, would be the same as Alternative 1 except Inner Bair Island would not be restored to tidal salt marsh. Using water control structures, managed salt marsh would be created on Inner Bair Island, a flow restrictor would be built in Smith Slough to prevent an unacceptable increase in tidal velocity at Pete's Harbor Marina and the slough would not be restored to its historic meander. Approximately 1,100 acres of tidal salt marsh would be restored on Outer and Middle Bair Island more quickly than the No Action Alternative for the endangered California clapper rail, salt marsh harvest mouse and other native wildlife. Three hundred acres of managed salt marsh would be created on Inner Bair Island for the salt marsh harvest mouse but no habitat would be created for the endangered California clapper rail. Public use would be the same as Alternative 1.
Alternative 4, the Tidal and Managed Marsh Restoration with Restricted Public Access Alternative would be a mixture of Alternative 2 and Alternative 3. The restoration of 1,100 acres of tidal salt marsh and 300 acres of managed salt marsh on Inner Bair Island would be the same as Alternative 3. The restricted public access would be the same as Alternative 2.
The Service invites the public to comment on the Draft Environmental Impact Statement/Environmental Impact Report during a 45-day public comment period. The Service will evaluate the comments submitted thereon to prepare a Final Environmental Impact Statement/Environmental Impact Report. A decision will be made no sooner than 30 days after the publication of the Final Environmental Impact Statement/Environmental Impact Report.
This notice is provided pursuant to regulations for implementing the National Environmental Policy Act of 1969 (40 CFR 1506.6)
Bureau of Land Management, Interior.
Notice of Call for Nominations.
The Bureau of Land Management (BLM) is publishing this Notice under Section 9(a)(2) of the Federal Advisory Committee Act to solicit public nominations for four members on the Gila Box Riparian NCA Advisory Committee. The Advisory Committee was created through Title 2, Section 201, of the Arizona Desert Wilderness Act of 1990 to provide informed advice to the Safford Field Manager on management of public lands in the Gila Box Riparian NCA in southeastern Arizona.
Any individual or organization may nominate one or more persons to serve on the Advisory Committee. Persons wishing to nominate themselves or other individuals should submit an application form, which is available from the BLM Safford Field Office or online at
Nominations and reference letters should be mailed to the BLM address on the application form, and must be received no later than September 30, 2004.
Jeff Wilbanks, BLM Safford Field Office, 711 14th Avenue, Safford, AZ 85546; call (928) 348-4573; or e-mail
To ensure membership of the Advisory Committee is balanced in terms of categories of interest represented, nominees must be qualified to provide advice in specific areas related to the primary purposes for which the NCA was created. These include wildlife conservation, riparian ecology, hydrology, outdoor recreation, watershed management, environmental education, cultural resources, or other related disciplines. Committee members are selected by the Secretary of the Interior to serve staggered terms of one to three years, with terms beginning on the date of appointment. The Advisory Committee will meet 2-4 times each year. Members serve without salary, but are reimbursed for travel and per diem expenses at current rates for government employees.
Bureau of Land Management, Interior.
Notice of Availability (NOA).
In accordance with the National Environmental Policy Act of 1969, the Bureau of Land Management (BLM) announces the availability of the ROD for Desolation Flats Natural Gas Field Development Project.
The document will be available electronically on the following Web site:
• Bureau of Land Management, Wyoming State Office, 5353 Yellowstone Road, Cheyenne, Wyoming 82003.
• Bureau of Land Management, Rawlins Field Office, 1300 N. 3rd Street, Rawlins, Wyoming 82301.
• Bureau of Land Management, Rock Springs Field Office, 280 Highway 191 North, Rock Springs, Wyoming 82901.
David Simons, Project Leader, Rawlins Field Office, 1300 N. 3rd Street, Rawlins, Wyoming 82301 or Teri Deakins, Rock Springs Field Office, 280 Highway 191 North, Rock Springs, Wyoming 82901. Mr. Simons and Ms. Deakins may be contacted by telephone at (307) 328-4200 and (307) 352-0329, respectively.
This ROD addresses approximately 233,542 acres of public lands administered by the BLM Rock Springs and Rawlins Field Offices, Carbon and Sweetwater Counties, Wyoming. A copy of the ROD has been sent to affected Federal, State, and local government agencies and interested parties.
Bureau of Land Management, Interior.
Notice.
Per Pub. L. 97-451, the lessee timely filed a petition for reinstatement of oil and gas lease MTM 88852, Blaine County, Montana. The lessee paid the required rental accruing from the date of termination.
We haven't issued any leases affecting the lands. The lessee agrees to new lease terms for rentals and royalties of $10 per acre and 16
The lessee met the requirements for reinstatement of the lease per Sec. 31(d) and (e) of the Mineral Leasing Act of 1920 (30 U.S.C. 188). We are proposing to reinstate the lease, effective the date of termination subject to:
• The original terms and conditions of the lease;
• the increased rental of $10 per acre;
• the increased royalty of 16
• the $155 cost of publishing this Notice
Karen L. Johnson, Chief, Fluids Adjudication Section, BLM Montana State Office, PO Box 36800, Billings, Montana 59107, (406) 896-5098.
General wage determination decisions of the Secretary of Labor are issued in accordance with applicable law and are based on the information obtained by the Department of Labor from its study of local wage conditions and data made available from other sources. They specify the basic hourly wage rates and fringe benefits which are determined to be prevailing for the described classes of laborers and mechanics employed on construction projects of a similar character and in the localities specified therein.
The determinations in these decisions of prevailing rates and fringe benefits have been made in accordance with 29 CFR Part 1, by authority of the Secretary of Labor pursuant to the provisions of the Davis-Bacon Act of March 3, 1931, as amended (46 Stat. 1494, as amended, 40 U.S.C. 276a) and of other Federal statutes referred to in 29 CFR Part 1, Appendix, as well as such additional statutes as may from time to time be enacted containing provisions for the payment of wages determined to be prevailing by the Secretary of Labor in accordance with the Davis-Bacon Act. The prevailing rates and fringe benefits determined in these decisions shall, in accordance with the provisions of the foregoing statutes, constitute the minimum wages payable on Federal and federally assisted construction projects to laborers and mechanics of the specified classes engaged on contract work of the character and in the localities described therein.
Good cause is hereby found for not utilizing notice and public comment procedure thereon prior to the issuance of these determinations as prescribed in 5 U.S.C. 553 and not providing for delay in the effective date as prescribed in that section, because the necessity to issue current construction industry wage determinations frequently and in large volume causes procedures to be impractical and contrary to the public interest.
General wage determination decisions, and modifications and supersedeas decisions thereto, contain no expiration dates and are effective from their date of notice in the
Any person, organization, or governmental agency having an interest in the rates determined as prevailing is encouraged to submit wage rate and fringe benefit information for consideration by the Department.
Further information and self-explanatory forms for the purpose of submitting this data may be obtained by writing to the U.S. Department of Labor, Employment Standards Administration, Wage and Hour Division, Division of Wage Determinations, 200 Constitution Avenue, NW., room S-3014, Washington, DC 20210.
The number of the decisions listed to the Government Printing Office document entitled “General Wage Determinations Issued Under the Davis-Bacon and related Acts” being modified are listed by Volume and State. Dates of publication in the
General wage determinations issued under the Davis-Bacon and related Acts, including those noted above, may be found in the Government Printing Office (GPO) document entitled “General Wage Determinations Issued Under the Davis-Bacon And Related Acts”. This publication is available at each of the 50 Regional Government Depository Libraries and many of the 1,400 Government Depository Libraries across the country.
General wage determinations issued under the Davis-Bacon and related Acts are available electronically at no cost on the Government Printing Office site at
When ordering hard-copy subscription(s), be sure to specify the State(s) of interest, since subscriptions may be ordered for any or all of the six separate Volumes, arranged by State. Subscriptions include an annual edition (issued in January or February) which includes all current general wage determinations for the States covered by each volume. Throughout the remainder of the year, regular weekly updates will be distributed to subscribers.
Occupational Safety and Health Administration (OSHA), Labor.
Request for public comment.
OSHA solicits comments concerning its request for an extension of the information collection requirements specified by the OSHA-7 Form.
Comments must be submitted by the following dates:
You may submit comments, identified by OSHA Docket No. ICR-1218-0064(2004), by any of the following methods:
(For additional information on submitting comments, please see the “Public participation” heading in the
Todd Owen, Directorate of Standards and Guidance, OSHA, Room N-3609, U.S. Department of Labor, 200 Constitution Avenue, NW., Washington, DC 20210; telephone (202) 693-2222.
You may submit comments and supporting materials in response to this document by (1) hard copy, (2) FAX transmission (facsimile), or (3) electronically through the OSHA Web page.
Because of security related problems, there may be a significant delay in the receipt of comments by regular mail. Please contact the OSHA Docket Office at (202) 693-2350 (TTY (877) 889-5627) for information about security procedures concerning the delivery of materials by express delivery, hand delivery and messenger service.
All comments, submissions and background documents are available for inspection and copying at the OSHA Docket Office at the above address. Comments and submissions posted on OSHA's Web page are available at
Electronic copies of this
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent (
This program ensures that information is in the desired format, reporting burden (time and costs) is minimal, collection instruments are clearly understood, and OSHA's estimate of the information collection burden is accurate. The Occupational Safety and Health Act of 1970 (the Act) (29 U.S.C. 651
Under paragraphs (a) and (c) of 29 CFR 1903.11 (“Complaints by employers”) employees and their representatives may notify the OSHA area director or an OSHA compliance officer of safety and health hazards regulated by the Agency that they believe exist in their workplaces at any time. These provisions state further that this notification must be in writing and “shall set forth with reasonable particularity the grounds for the notice, and shall be signed by the employee or representatives of the employee.”
Along with providing specific hazard information to the Agency, paragraph (a) permits employees/employee representatives to request an inspection of the workplace. Paragraph (c) also addresses situations in which employees/employee representatives may provide the information directly to the OSHA compliance officer during an inspection. An employer's former employees may also submit complaints to the Agency.
To address the requirements of paragraphs (a) and (c), especially the requirement that the information be in writing, the Agency developed the OSHA-7 Form; this form standardized and simplified the hazard-reporting process. For paragraph (a), they may complete an OSHA-7 Form obtained from the Agency's Web site and then send it to OSHA on-line, or deliver a hardcopy of the form to the OSHA area office by mail or facsimile, or by hand. They may also write a letter containing the information and hand-deliver it to the area office, or send it by mail or facsimile. In addition, they may provide the information orally to the OSHA area office or another party (
The information in the hardcopy version of the OSHA-7 Form includes information about the employer and alleged hazards, including: The establishment's name, mailing address, and telephone and facsimile numbers; the site's address and telephone facsimile numbers; the name and telephone number of the management official; the type of business; a description, and the specific location of the hazards, including the approximate number of employees exposed or threatened by the hazards; and whether or not the employee/employee representative informed another government agency about the hazards (and the name of the agency if informed).
Additional information on the hardcopy version of the form addresses the complainant including: Whether or not the complainant wants OSHA to reveal their name to the employer; whether the complainant is an employee or an employee representative, or for information provided orally, a member of a Federal safety and health committee or another party (with space to specify the party); the complainant's name, telephone number, and address; and the complainant's signature attesting that they believe a violation of an OSHA standard exists at the named establishment; and the date of the signature. An employee representative must also provide the name of the organization they represent and their title.
The information contained in the on-line version of the OSHA-7 Form is similar to the hard copy version. However, the on-line version requests the complainant's e-mail address, and
The Agency uses the information collected on the OSHA-7 Form to determine whether reasonable grounds exist to conduct an inspection of the workplace. The description of the hazards, including the number of exposed employees, allows the Agency to asses the severity of the hazards and the need to expedite the inspection. The completed form also provides an employer with notice of the complaint and may serve as the basis for obtaining a search warrant if an employer denies the Agency access to the workplace.
OSHA has a particular interest in comments on the following issues:
• Whether the information collection requirements are necessary for the proper performance of the Agency's functions, including whether the information is useful;
• The accuracy of the Agency's estimate of the burden (time and costs) of the information collection requirements, including the validity of the methodology and assumptions used;
• The quality, utility, and clarity of the information collected; and
• Ways to minimize the burden on employers who must comply; for example, by using automated or other technological information collection and transmission techniques.
OSHA is proposing to extend the information collection requirements contained on the OSHA-7 Form. The Agency will summarize the comments submitted in response to this notice and will include this summary in the request to OMB to extend the approval of the information collection requirement contained in the Standard.
John L. Henshaw, Assistant Secretary of Labor for Occupational Safety and Health, directed the preparation of this notice. The authority for this notice is the Paperwork Reduction Act of 1995 (44 U.S.C. 3506), and Secretary of Labor's Order No. 5-2002 (67 FR 65008).
Occupational Safety and Health Administration (OSHA), Labor.
Request for comment.
OSHA solicits comments concerning its proposal to extend OMB approval of the Information Collection Requirements contained in the Gear Certification Standard (29 CFR part 1919). These maritime regulations require employers to have an OSHA 71 Form issued for equipment found to be in a safe condition and the OSHA 72 Form issued to equipment that is unsafe. These forms are issued by third parties who have applied to OSHA, on the OSHA 70 Form, for accreditation to certify gear used in maritime employment.
Comments must be submitted by the following dates:
You may submit comments, identified by OSHA Docket No. ICR-1218-0003 (2004), by any of the following methods:
(For additional information on submitting comments, please see the “Public Participation” heading in the
Theda Kenney or Todd Owen, Directorate of Standards and Guidance, OSHA, Room N-3609, U.S. Department of Labor, 200 Constitution Avenue, NW., Washington, DC 20210; telephone (202) 693-2222.
You may submit comments and supporting materials in response to this notice by (1) hard copy, (2) fax transmission (facsimile), or (3) electronically through the OSHA Web page. Because of security related problems, there may be a significant delay in the receipt of comments by regular mail. Please contact the OSHA Docket Office at (202) 2693-2350 (TTY (877) 889-5627) for information about security procedures concerning the delivery of materials by express delivery, hand delivery and messenger service.
All comments, submissions and background documents are available for inspection and copying at the OSHA Docket Office at the above address. Comments and submissions posted on OSHA's Web page are available at
Electronic copies of this
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent (
This program ensures that information is in the desired format, reporting burden (time and costs) is minimal, collection instruments are clearly understood, and OSHA's estimate of the information collection burden is accurate. The Occupational safety and Health Act of 1970 (the Act) (29 U.S.C. 651
The OSHA 70 Form is used by applicants seeking accreditation from OSHA to be able to test or examine certain equipment and material handling devices, as required under the maritime regulations, part 1917 (Marine Terminals), and part 1918 (Longshoring). The OSHA 70 Form application for accreditation provides an easy means for companies to apply for accreditation.
The OSHA 71 Form is required to be issued by the those accredited by OSHA to employers in the maritime industry to make known that certain equipment and material handling devices are safe to use of operate. The OSHA 72 Form is required to be issued by those accredited by OSHA to employers in the maritime industry when the equipment or material handling device is found to be unsafe to use.
The collection of the information needed to complete these forms is necessary to provide an affective and efficient means of enabling employers and employees to determine if cargo gear, equipment and/or other material handling devices are safe to use.
OSHA has a particular interest in comments on the following issues:
• OSHA has a particular interest in comments on the following times.
• Whether the proposed information collection requirements are necessary for the proper performance of the Agency's functions, including whether the information is useful;
• The accuracy of OSHA's estimate of the burden (time and costs) of the information-collection requirements, including the validity of the methodology and improvement used;
• The quality, utility, and clarity of the information collected; and
• Ways to minimize the burden on employers who must comply; for example, by using automated or other technological information collection and transmission techniques.
OSHA is proposing to extend the information collection requirements in the Gear Certification Standard (29 CFR part 1919). The Agency will summarize the comments submitted in response to this notice and will include this summary in its request to OMB to extend the approval of these information collection requirements contained in the Standard.
John L. Henshaw, Assistant Secretary of the Labor for Occupational Safety and Health, directed the preparation of this notice. The authority for this notice is the Paperwork Reduction Act of 1995 (44 U.S.C. 3506
U.S. Nuclear Regulatory Commission.
Notice of meeting.
The U.S. Nuclear Regulatory Commission will convene a meeting of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) on October 13 and 14, 2004. A sample of agenda items to be discussed during the public sessions includes: (1) Use of I-125 Brachytherapy Seeds as Markers; (2) Proposed Changes to Abnormal Occurrence Criteria; (3) Discussion of Medical Event Criteria; and, (4) Update on St. Joseph Mercy Hospital Dose Reconstruction Case. To review the agenda, see
Discuss issues related to 10 CFR Part 35, Medical Use of Byproduct Material.
October 13, 2004, from 8 a.m. to 10 a.m. This session will be closed so that NRC staff can give the ACMUI its required annual ethics briefing.
October 13, 2004, from 8:30 a.m. to 5 p.m.; October 14, 2004, from 8 a.m. to 5 p.m.
U.S. Nuclear Regulatory Commission, Two White Flint North Building, Room T2B3, 11545 Rockville Pike, Rockville, MD 20852-2738.
Angela R. McIntosh, telephone (301) 415-5030; e-mail
Leon S. Malmud, M.D., will chair the meeting. Dr. Malmud will conduct the meeting in a manner that will facilitate the orderly conduct of business. The following procedures apply to public participation in the meeting:
1. Persons who wish to provide a written statement should submit a
2. Questions from members of the public will be permitted during the meeting, at the discretion of the Chairman.
3. The transcript and written comments will be available for inspection on NRC's Web site (
4. Attendees are requested to notify Angela R. McIntosh at (301) 415-5030 of their planned attendance if special services, such as for the hearing impaired, are necessary.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Issuance of order for implementation of additional security measures associated with access authorization.
John Hickman, Project Manager, Decommissioning Directorate, Division of Waste Management and Environmental Protection, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Rockville, MD 20852. Telephone: (301) 415-3017; fax number: (301) 415-5398; e-mail
Pursuant to Code of Federal Regulations Title 10 part 2.106, the Nuclear Regulatory Commission is providing notice in the matter of decommissioning power reactor licensees order modifying license (effective immediately).
I. The licensees identified in Attachment 2 to this Order hold licenses issued by the Nuclear Regulatory Commission (NRC or Commission) authorizing possession of nuclear power plants in accordance with the Atomic Energy Act of 1954 and Code of Federal Regulations Title 10 (10 CFR) part 50. Commission regulations at 10 CFR 50.54(p)(1) require these licensee to maintain safeguards contingency plan procedures in accordance with 10 CFR part 73, Appendix C. Specific safeguards requirements are contained in 10 CFR 73.55.
II. On September 11, 2001, terrorists simultaneously attacked targets in New York, N.Y., and Washington, DC, utilizing large commercial aircraft as weapons. In response to the attacks and intelligence information subsequently obtained, the Commission issued a number of Safeguards and Threat Advisories to its licensees in order to strengthen licensees' capabilities and readiness to respond to a potential attack on a nuclear facility. The Commission has also communicated with other Federal, State, and local government agencies and industry representatives to assess the adequacy of security measures at licensed facilities. In addition, the Commission conducted a comprehensive review of its safeguards and security programs and requirements.
As a result of its initial consideration of current safeguards and security requirements and the Order issued on May 23, 2002, as well as a review of information provided by the intelligence community, the Commission has determined that certain additional security measures are required to address the current threat environment. Therefore, the Commission is imposing requirements, as set forth in Attachment 1
The Commission recognizes that licensees may have already initiated many of the measures set forth in Attachment 1 to this Order in response to previously issued advisories, the May 2002 Order, or on their own. It also recognizes that some measures may not be possible or may need to be tailored to accommodate the specific circumstances existing at the licensee's facility to achieve the intended objectives and avoid any unforeseen effect on safety.
Although the additional security measures implemented by licensees in response to the Safeguards and Threat Advisories and the May 2002 Order have been adequate to provide reasonable assurance of adequate protection of public health and safety, the Commission concludes that these security measures must be supplemented further because the current threat environment continues to persist. Therefore, it is appropriate to require additional security measures and these measures must be embodied in an Order, consistent with the established regulatory framework. In order to provide assurance that licensees are implementing prudent measures to achieve a consistent level of protection to address the current threat environment, all licenses identified in Attachment 2 to this Order shall be modified to include the requirements identified in Attachment 1 to this Order. In addition, pursuant to 10 CFR 2.202, I find that in the circumstances described above, the public health, safety and interest require that this Order be immediately effective.
III. Accordingly, pursuant to Sections 103, 104, 161b, 161i, 161o, 182 and 186 of the Atomic Energy Act of 1954, as amended, and the Commission's regulations in 10 CFR 2.202 and 10 CFR parts 50 and 73, it is hereby ordered, effective immediately, that all licenses identified in Attachment 2 to this order are modified as follows:
A. All licensees shall, notwithstanding the provisions of any Commission regulation or license to the contrary, comply with the requirements described in Attachment 1 to this Order except to the extent that a more stringent requirement is set forth in the licensee's security plan. The licensees shall immediately start implementation of the requirements in Attachment 1 to the Order and shall complete implementation no later than 180 days from the date of this Order with the exception of additional security
B.1. The Licensee shall, within twenty (20) days of the date of this Order, notify the Commission, (1) if it is unable to comply with any of the requirements described in Attachment 1, (2) if compliance with any of the requirements is unnecessary in its specific circumstances, or (3) if implementation of any of the requirements would cause the licensee to be in violation of the provisions of any Commission regulation or the facility license. The notification shall provide the licensee's justification for seeking relief from or variation of any specific requirement.
2. Any licensee that considers that implementation of any of the requirements described in Attachment 1 to this Order would adversely impact the safety of the facility must notify the Commission, within twenty (20) days of this Order, of the adverse safety impact, the basis for its determination that the requirement has an adverse safety impact, and either a proposal for achieving the same objectives specified in the Attachment 1 requirements in question, or a schedule for modifying the facility to address the adverse safety condition. If neither approach is appropriate, the licensee must supplement its response to Condition B.1 of this Order to identify the condition as a requirement with which it cannot comply, with attendant justifications as required under Condition B.1.
C.1. All licensees shall, within twenty (20) days of this Order, submit to the Commission a schedule for achieving compliance with each requirement described in Attachment 1.
2. All licensees shall report to the Commission when they have achieved full compliance with the requirements described in Attachment 1.
D. Notwithstanding the provisions of 10 CFR 50.54(p), all measures implemented or actions taken in response to this Order shall be maintained until the Commission determines otherwise. The Licensee's response to Conditions B.1, B.2, C.1, and C.2, above shall be submitted in accordance with 10 CFR 50.4. In addition, licensee submittals that contain Safeguards Information shall be properly marked and handled in accordance with 10 CFR 73.21. The Director, Office of Nuclear Material Safety and Safeguards, may, in writing, relax or rescind any of the above conditions upon demonstration by the Licensee of good cause.
IV. In accordance with 10 CFR 2.202, the licensee must, and any other person adversely affected by this Order may, submit an answer to this Order, and may request a hearing on this Order, within twenty (20) days of the date of this Order. Where good cause is shown, consideration will be given to extending the time to request a hearing. A request for extension of time in which to submit an answer must be made in writing to the Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, and include a statement of good cause for the extension. The answer may consent to this Order. Unless the answer consents to this Order, the answer shall, in writing and under oath or affirmation, specifically set forth the matters of fact and law on which the licensee or other person adversely affected relies and the reasons as to why the Order should not have been issued. Any answer or request for a hearing shall be submitted to the Secretary, Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, ATTN: Rulemakings and Adjudications Staff, Washington, DC 20555. Copies also shall be sent to the Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, to the Assistant General Counsel for Materials Litigation and Enforcement at the same address, to the Regional Administrator for NRC Region I, II, III or IV as appropriate for the specific facility; and to the licensee if the answer or hearing request is by a person other than the licensee. Because of possible disruptions in delivery of mail to United States Government offices, it is requested that requests for a hearing be transmitted to the Secretary of the Commission either by means of facsimile transmission to 301-415-1101 or by e-mail to
If a hearing is requested by the Licensee or a person whose interest is adversely affected, the Commission will issue an Order designating the time and place of any hearing. If a hearing is held, the issue to be considered at such hearing shall be whether this Order should be sustained.
Pursuant to 10 CFR 2.202(c)(2)(i), the Licensee may, in addition to demanding a hearing at the time the answer is filed or sooner, move the presiding officer to set aside the immediate effectiveness of the Order on the grounds that the Order, including the need for immediate effectiveness, is not based on adequate evidence but on mere suspicion, unfounded allegations or error.
In the absence of any request for hearing or written approval of an extension of time in which to request a hearing, the provisions specified in Section III above shall be final twenty (20) days from the date of this Order without further order or proceedings. If an extension of time for requesting a hearing has been approved, the provisions specified in Section III shall be final when the extension expires, if a hearing request has not been received. An answer or a request for hearing shall not stay the immediate effectiveness of this order.
Thursday, September 9, 2004, 10 a.m. (Open portion) 10:15 a.m. (Closed portion).
Offices of the Corporation, Twelfth Floor Board Room, 1100 New York Avenue, NW., Washington, DC.
Meeting Open to the Public from 10 a.m. to 10:15 a.m. Closed portion will commence at 10:15 a.m. (approx.).
(Closed to the public 10:15 a.m.)
Information on the meeting may be obtained from Connie M. Downs at (202) 336-8438.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
NASD is proposing to amend Rules 2210 and 2211 of NASD to require mutual fund communications with the public that provide performance data to disclose the fund's fees, expenses and standardized performance. Below is the text of the proposed rule change. Proposed new language is in italics.
(a) through (c) No change.
(1) through (2) No change.
(e) No change.
(a) through (c) No change.
(1) All institutional sales material and correspondence are subject to the content standards of Rule 2210(d)(1) and the applicable Interpretive Materials under Rule 2210,
(2) through (3) No change.
In its filing with the Commission, NASD 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. NASD has prepared summaries, set forth in Sections (A), (B), and (C) below, of the most significant aspects of such statements.
NASD proposes to amend Rules 2210 and 2211 to require member communications with the public, other than institutional sales material, that present mutual fund performance information to disclose the fund's fees, expenses and standardized performance. These new requirements would improve investor awareness of the costs of buying and owning a mutual fund, facilitate comparison of funds and make the presentation of standardized performance more prominent. The proposed rule change would require that:
• Performance sales material disclose the fees and expenses associated with purchase and ownership of the fund, derived from the fund's most recent prospectus and stated as a percentage of net assets;
• Performance sales material disclose the standardized performance of the mutual fund, as prescribed in SEC Rules 482 and 34b-1; and
• Advertisements (other than radio, television or video advertisements)
The proposed rule change is consistent with the provisions of Section 15A(b)(6) of the Act, which requires, among other things, that NASD's rules be designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, and to protect investors and the public interest. The proposed rule change will enhance investor protection by making more transparent the true costs of purchasing and owning a mutual fund and providing useful information on which to base investment decisions.
NASD does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act, as amended.
The proposed rule change was published for comment in NASD Notice to Members 03-77 (the “NtM”). NASD received 11 comments in response to the NtM. Of the 11 comment letters received, six supported the proposed rule change, and five opposed it.
Some commenters asserted that the proposed rule change would confuse investors or is otherwise unnecessary.
SEC Rules 482 and 34b-1 already require disclosure of a broker-sold fund's sales load in performance sales material. The proposed rule change also would require the disclosure of the fund's expense ratio in performance sales material, whether the sales material is distributed by a full-service broker/dealer, a discount broker/dealer, or the underwriter for a directly-marketed fund. Moreover, NASD finds no convincing rationale why lower-cost or directly-marketed funds should object to the proposed presentation of their expense ratios. Indeed, several no-load and directly-marketed mutual fund complexes supported the proposed rule change.
Some commenters also asserted that the proposed rule change would invite investors to pay undue attention to a fund's performance.
Some commenters opposed the requirement that the required disclosure appear in a prominent text box.
The NtM requested comment on whether the proposed rule change should require disclosure of the dollar amount of expenses incurred by a hypothetical shareholder in the fund. Commenters generally opposed such an approach.
Several commenters recommended that the proposed rule change not apply to institutional sales material, in light of the sophistication and expertise of institutional investors.
Some commenters recommended that the proposed rule change require disclosure of fund expenses as calculated in Item 9 of Form N-1A, rather than Item 3.
Some commenters objected to the proposed requirement that the disclosure of fund expenses be current as of the most recent calendar quarter.
Vanguard requested that NASD adopt a “one click away” rule for the depiction of the required disclosure in electronic communications. Under this approach, an investor could click on a hyperlink in close proximity to nonstandardized performance in order to obtain the required disclosure. In its recent amendments to Rule 482, the SEC rejected a “one-click away” rule for performance-related disclosures required by paragraph (b)(3).
The NtM would have provided that the required disclosure be in a type size at least as large as that of the nonstandardized performance. The ICI requested that the proposed rule change instead require that the type size of the required information be at least as large as that used in the major part of a print advertisement. A purpose of the proposed rule change is to require fee, expense and standardized performance disclosure that will balance the nonstandardized performance. In order to meet this particular purpose, NASD has revised the proposal to require that all disclosure be set forth clearly and prominently, and to require that disclosure of standardized performance be in a type size at least as large as that of the nonstandardized performance.
NASD also has amended the proposed rule change to clarify certain other disclosure requirements. We have eliminated the provision that allows communications delivered through an electronic medium to present the disclosure “in a manner that is intended to draw investor attention to it.” Upon further consideration we have determined that this standard may be too vague. Under the proposed rule change as amended, Web sites would have to comply with the prominent text box and type size requirements and radio, television and video advertisements would have to provide the required disclosure “with equal emphasis” to that given to any nonstandardized performance.
Some commenters also requested that NASD amend the proposed rule change to require disclosure of the “maximum deferred sales charge” rather than the “maximum
Two commenters requested clarification of whether the proposed rule change would apply to variable annuity sales material.
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 Jonathan G. Katz, Secretary, Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC 20549-0609.
All submissions should refer to File Number SR-NASD-2004-043. This file number should be included on the subject line if e-mail is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site (
For the Commission, by the Division of Market Regulation, pursuant to delegated authority.
The Department of State announces the meeting of the Secretary of State's Advisory Committee on Leadership and Management on Wednesday, September 8 in Room 1107 of the U.S. Department of State at 2201 C Street, NW., Washington, DC. The meeting will take place from 1:30 p.m. to 3:30 p.m.
This will be the inaugural meeting of the Committee. Deputy Secretary of State Richard Armitage will chair the meeting. Secretary Powell invited a bipartisan group of prominent Americans to be members of the Committee earlier this year. With their participation and advice, the Department seeks to enhance the ability to carry out U.S. foreign policy today and into the future.
Members of the press and general public may attend the meeting, though attendance will be limited to the seating available. Access to the building is controlled, and photographic identification and individual building passes are required for all attendees.
To attend the meeting, please contact Carlene Roy (
Federal Aviation Administration (FAA), DOT.
Notice of RTCA Special Committee 200 meeting.
The FAA is issuing this notice to advise the public of a meeting of RTCA Special Committee 200: Integrated Modular Avionics.
The meeting will be held on September 14-17, 2004 from 9 a.m. to 5 p.m.
The meeting will be held at RTCA, 1828 L Street, NW., Suite 805, Washington, DC 20036-5133.
(1) RTCA Secretariat, 1828 L Street, NW., Suite 805, Washington, DC 20036-5133; telephone (202) 833-9339; fax (202) 833-9434; Web site
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., Appendix 2), notice is hereby given for a Special Committee 200 meeting. The agenda will include:
Attendance is open to the interested public but limited to space availability. With the approval of the Chairmen, members of the public may present oral statements at the meeting. Persons wishing to present statements or obtain information should contact the person listed in the
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of renewal of exemption; request for comments.
This notice publishes the FMCSA decision to renew the exemptions from the vision requirement in the Federal Motor Carrier Safety Regulations for 48 individuals. The FMCSA has statutory authority to exempt individuals from vision standards if the exemptions granted will not compromise safety. The agency has concluded that granting these exemptions will provide a level of safety that will be equivalent to, or greater than, the level of safety maintained without the exemptions for these commercial motor vehicle (CMV) drivers.
This decision is effective September 21, 2004. Comments from interested persons should be submitted by September 27, 2004.
You may submit comments identified by DOT DMS Docket Numbers FMCSA-99-6156, FMCSA-2000-7006, and FMCSA-2000-7165 by any of the following methods:
• Web Site:
• Fax: 1-202-493-2251.
• Mail: Docket Management Facility; U.S. Department of Transportation, 400 Seventh Street, SW., Nassif Building, Room PL-401, Washington, DC 20590-0001.
• Hand Delivery: Room PL-401 on the plaza level of the Nassif Building, 400 Seventh Street, SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
• Federal eRulemaking Portal: Go to
Ms. Teresa Doggett, Office of Bus and Truck Standards and Operations, (202) 366-2990, FMCSA, Department of Transportation, 400 Seventh Street, SW., Washington, DC 20590-0001. Office hours are from 8 a.m. to 5:30 p.m., e.s.t., Monday through Friday, except Federal holidays.
Under 49 U.S.C. 31315 and 31136(e), the FMCSA may renew an exemption from the vision requirement in 49 CFR 391.41(b)(10), which applies to drivers of CMVs in interstate commerce, for a two year period if it finds “such exemption would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved absent such exemption.” The procedures for requesting an exemption (including renewals) are set out in 49 CFR part 381. This notice addresses 48 individuals who have requested renewal of their exemptions in a timely manner. The FMCSA has evaluated these 48 applications for renewal on their merits and decided to extend each exemption for a renewable two year period. They are:
These exemptions are extended subject to the following conditions: (1) That each individual have a physical exam every year (a) by an ophthalmologist or optometrist who attests that the vision in the better eye continues to meet the standard in 49 CFR 391.41(b)(10), and (b) by a medical examiner who attests that the individual is otherwise physically qualified under 49 CFR 391.41; (2) that each individual provide a copy of the ophthalmologist's or optometrist's report to the medical examiner at the time of the annual medical examination; and (3) that each individual provide a copy of the annual medical certification to the employer for retention in the driver's qualification file and retain a copy of the certification on his/her person while driving for presentation to a duly authorized Federal, State, or local enforcement official. Each exemption will be valid for two years unless rescinded earlier by the FMCSA. The exemption will be rescinded if: (1) The person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained before it was granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31315 and 31136(e).
Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no longer than two years from its approval date and may be renewed upon application for additional two year periods. In accordance with 49 U.S.C. 31315 and 31136(e), each of the 48 applicants has satisfied the entry conditions for obtaining an exemption from the vision requirements (64 FR 54948, 65 FR 159, 67 FR 57266, 65 FR 20245, 65 FR 57230, 65 FR 33406, 65 FR 57234). Each of these 48 applicants has requested timely renewal of the exemption and has submitted evidence showing that the vision in the better eye continues to meet the standard specified at 49 CFR 391.41(b)(10) and that the vision impairment is stable. In addition, a review of each record of safety while driving with the respective vision deficiencies over the past two years indicates each applicant continues to meet the vision exemption standards. These factors provide an adequate basis for predicting each driver's ability to continue to drive safely in interstate commerce. Therefore, the FMCSA concludes that extending the exemption for each renewal applicant for a period of two years is likely to achieve a level of safety equal to that existing without the exemption.
The FMCSA will review comments received at any time concerning a particular driver's safety record and determine if the continuation of the exemption is consistent with the requirements at 49 U.S.C. 31315 and 31136(e). However, the FMCSA requests that interested parties with specific data concerning the safety records of these drivers submit comments by September 27, 2004.
In the past the FMCSA has received comments from Advocates for Highway and Auto Safety (Advocates) expressing continued opposition to the FMCSA's
The issues raised by Advocates were addressed at length in 69 FR 51346 (August 18, 2004). The FMCSA continues to find its exemption process appropriate to the statutory and regulatory requirements.
Federal Transit Administration, DOT.
Notice of request for comments.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Comments must be submitted before September 27, 2004. A comment to OMB is most effective if OMB receives it within 30 days of publication.
Sylvia L. Marion, Office of Administration, Office of Management Planning, (202) 366-6680.
The information collected is used to report annually to Congress, the Secretary, and to the Federal Transit Administrator on how grantees are responding to national emphasis areas and congressional direction, and allows FTA to trace grantees' use of federal planning and research funds.
All written comments must refer to the docket number that appears at the top of this document and be submitted to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725-17th Street, NW., Washington, DC 20503, Attention: FTA Desk Officer.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation.
Denial of petition for an investigation into the adequacy of a safety recall.
This notice sets forth the reasons for the denial of a petition submitted to NHTSA under 49 U.S.C. 30120(e) by Ms. Angelique Trowbridge, requesting that the agency commence a proceeding to determine the adequacy of the remedy utilized by Ford Motor Company (Ford) to address a safety-related defect in Ford Safety Recall 04S13 (NHTSA 04V-165). After a review of the petition and other information, NHTSA has concluded that further expenditure of the agency's investigative resources on the issues raised by the petition does not appear warranted. The agency accordingly has denied the petition. The petition is hereinafter identified as RP04-002.
Mr. Thomas Z. Cooper, Chief, Vehicle Integrity Division, Office of Defects Investigation (ODI), NHTSA, 400 Seventh Street, SW., Washington, DC 20590. Telephone: (202) 366-5218.
On June 22, 2004, NHTSA received a letter from Ms. Trowbridge requesting that the agency investigate the adequacy of the remedy used by Ford in Safety Recall 04S13 (NHTSA 04V-165). The petitioner alleges that the recall remedy is inadequate and, as evidence, states that after having the recall remedy performed on her model year (MY) 2001 Ford Escape, it did not resolve the stalling condition.
On April 5, 2004, Ford filed a Defect Information Report concerning intermittent closed throttle engine stalling in 321,903 MY 2001-2003 Ford Escape vehicles equipped with 3.0L V6 engines, manufactured between January 31, 2000 and September 11, 2002. Ford reported that an intermittent engine stalling condition is prevalent in these vehicles when the vehicle is in a closed throttle deceleration at speeds of 40 mph and below. The recall remedy involved reprogramming the calibration of the vehicle's Powertrain Control Module (PCM) to correct a rich air/fuel mixture, thereby allowing the engine to operate without experiencing a closed throttle, deceleration-stalling event.
Following receipt of the petition, on July 1, 2004, the Office of Defects Investigation (ODI) sent an information request to Ford to obtain relevant information. Ford's July 23, 2004 response indicates that less than 0.1 percent of vehicle owners who have had the recall remedy performed have reported additional deceleration stalling issues. Ford also states that the PCM has to “learn” the new program and that any subsequent stalling would be temporary. To verify Ford's claim, ODI conducted a random survey of 20 complainants who had the remedy performed on their vehicles and who experienced a subsequent stalling event. ODI found that most of them had isolated stalling problems, supporting Ford's allegation
In addition, in a phone conversation with ODI, the petitioner stated that a Ford engineer found a faulty ignition switch as the cause of the stalling in her vehicle. Thus, there is no evidence at this time to suggest that the recall remedy is inadequate.
For the foregoing reasons, further expenditure of the agency's investigative resources on the issues raised by the petition does not appear to be warranted. Therefore, the petition is denied.
49 U.S.C. 30120(e); delegations of authority at CFR 1.50 and 501.8.
National Highway Traffic Safety Administration, DOT.
Notice of receipt of petition for decision that nonconforming 2002 Honda CRV multipurpose passenger vehicles are eligible for importation.
This document announces receipt by the National Highway Traffic Safety Administration (NHTSA) of a petition for a decision that 2002 Honda CRV multipurpose passenger vehicles that were not originally manufactured to comply with all applicable Federal motor vehicle safety standards are eligible for importation into the United States because (1) they are substantially similar to vehicles that were originally manufactured for importation into and sale in the United States and that were certified by their manufacturer as complying with the safety standards, and (2) they are capable of being readily altered to conform to the standards.
The closing date for comments on the petition is September 27, 2004.
Comments should refer to the docket number and notice number, and be submitted to: Docket Management, Room PL-401, 400 Seventh St., SW., Washington, DC 20590. [Docket hours are from 9 a.m. to 5 p.m.]. Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
Coleman Sachs, Office of Vehicle Safety Compliance, NHTSA (202-366-3151).
Under 49 U.S.C. 30141(a)(1)(A), a motor vehicle that was not originally manufactured to conform to all applicable Federal motor vehicle safety standards shall be refused admission into the United States unless NHTSA has decided that the motor vehicle is substantially similar to a motor vehicle originally manufactured for importation into and sale in the United States, certified under 49 U.S.C. 30115, and of the same model year as the model of the motor vehicle to be compared, and is capable of being readily altered to conform to all applicable Federal motor vehicle safety standards.
Petitions for eligibility decisions may be submitted by either manufacturers or importers who have registered with NHTSA pursuant to 49 CFR part 592. As specified in 49 CFR 593.7, NHTSA publishes notice in the
US SPECS of Aberdeen, Maryland (Registered Importer 03-321) has petitioned NHTSA to decide whether nonconforming 2002 Honda CRV multipurpose passenger vehicles are eligible for importation into the United States. The vehicles which US SPECS believes are substantially similar are 2002 Honda CRV multipurpose passenger vehicles that were manufactured for importation into, and sale in, the United States and certified by their manufacturer as conforming to all applicable Federal motor vehicle safety standards.
The petitioner claims that it carefully compared non-U.S. certified 2002 Honda CRV multipurpose passenger vehicles to their U.S.-certified counterparts, and found the vehicles to be substantially similar with respect to compliance with most Federal motor vehicle safety standards.
US SPECS submitted information with its petition intended to demonstrate that non-U.S. certified 2002 Honda CRV multipurpose passenger vehicles as originally manufactured, conform to many Federal motor vehicle safety standards in the same manner as their U.S. certified counterparts, or are capable of being readily altered to conform to those standards.
Specifically, the petitioner claims that non-U.S. certified 2002 Honda CRV multipurpose passenger vehicles are identical to their U.S. certified counterparts with respect to compliance with Standard Nos. 102
The petitioner also contends that the vehicles are capable of being readily altered to meet the following standards, in the manner indicated:
Standard No. 101
Standard No. 108
Standard No. 111
Standard No. 114
Standard No. 118
Standard No. 120
Standard No. 201
Standard No. 208
The petitioner states that the passive restraint system used in these vehicles consists of dual front airbags.
The petitioner also states that the vehicles have combination lap and shoulder belts at the outboard front seating positions as well as at the rear outboard seating positions. These manual systems are automatic self-tensioning and are released by means of a single red push-button.
Standard No. 209
Standard No. 225
Standard No. 301
The petitioner also states that a vehicle identification plate must be affixed to the vehicles near the left windshield post to meet the requirements of 49 CFR part 565.
Interested persons are invited to submit comments on the petition described above. Comments should refer to the docket number and be submitted to: Docket Management, Room PL-401, 400 Seventh St., SW., Washington, DC 20590. [Docket hours are from 9 a.m. to 5 p.m.]. It is requested but not required that 10 copies be submitted.
All comments received before the close of business on the closing date indicated above will be considered, and will be available for examination in the docket at the above address both before and after that date. To the extent possible, comments filed after the closing date will also be considered. Notice of final action on the petition will be published in the
49 U.S.C. 30141(a)(1)(A) and (b)(1); 49 CFR 593.8; delegations of authority at 49 CFR 1.50 and 501.8.
Research and Special Programs Administration, DOT.
List of applications for modification of exemption.
In accordance with the procedures governing the application for, and the processing of, exemptions from the Department of Transportation's Hazardous Material Regulations (49 CFR Part 107, Subpart B), notice is hereby given that the Office of Hazardous Materials Safety has received the application described herein. This notice is abbreviated to expedite docketing and public notice. Because the sections affected, modes of transportation, and the nature of application have been shown in earlier
Comments must be received on or before September 13, 2004.
Record Center, Research and Special Programs Administration, U.S. Department of Transportation, Washington, DC 20590.
Comments should refer to the application number and be submitted in triplicate. If Confirmation of receipt of comments is desired, include a self-addressed stamped postcard showing the exemption number.
Copies of the applications are available for inspection in the Records Center, Nassif Building, 400 7th Street SW., Washington, DC or at
This notice of receipt of applications for modification of exemption is published in accordance with Part 107 of the Federal hazardous materials transportation law (49 U.S.C. 5517(b); 49 CFR 1.53(b)).
Research and Special Programs Administration, DOT.
List of applications for exemption.
In accordance with the procedures governing the application for, and the processing of, exemptions from the Department of Transportation's Hazardous Material Regulations (49 CFR Part 107, Subpart B), notice is hereby given that the Office of Hazardous Materials Safety has received the application described herein. Each mode of transportation for which a particular exemption is requested is indicated by a number in the “Nature of Application” portion of the table below as follows: 1—Motor vehicle, 2—Rail freight, 3—Cargo vessel, 4—Cargo aircraft only, 5—Passenger-carrying aircraft.
Comments must be received on or before September 27, 2004.
Record Center, Research and Special Programs Administration, U.S. Department of Transportation, Washington, DC 20590.
Comments should refer to the application number and be submitted in triplicate. If Confirmation of receipt of comments is desired, include a self-addressed stamped postcard showing the exemption number.
Copies of the applications are available for inspection in the Records Center, Nassif Building, 400 7th Street SW., Washington DC or at
This notice of receipt of application for modification of exemption is published in accordance with Part 107 of the Federal hazardous materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).
Research and Special Programs Administration (RSPA), DOT.
Notice; grant of waiver.
Duke Energy Gas Transmission Company (DEGT) petitioned the Research and Special Programs Administration's Office of Pipeline Safety (RSPA/OPS) for waiver of compliance with 49 CFR 192.611, which requires natural gas pipeline operators to confirm or revise the maximum allowable operating pressure (MAOP) of a pipeline after a change in class location. DEGT proposed an alternative set of risk control activities in lieu of a reduction in pressure or pressure testing of certain pipeline segments in Pennsylvania in areas that have changed from Class 1 to Class 2.
In a September 13, 2002, letter, as supplemented by a letter dated February 28, 2003, DEGT requested a waiver of compliance with 49 CFR 192.611, which requires pipeline operators to confirm or revise the MAOP on their pipelines after a change in class location. DEGT identified changes from Class 1 to Class 2 in four gas transmission pipeline segments in Pennsylvania on DEGT's Lines 12 and 19, two parallel pipelines that are part of its Texas Eastern Pipeline System. DEGT proposed to conduct alternative risk control activities based on Integrity Management Program principles and requirements in lieu of compliance with 192.611 and requested an extension of the 18-month time limit to allow it to develop and propose the alternative activities. On June 11, 2003, RSPA/OPS published a notice in the
DEGT's waiver request involves four segments on its 24-inch Line 12 and its 30-inch Line 19 (the “waiver segments”). The waiver segments were constructed between 1954 and 1963 and were hydrotested to at least 100% of the pipe's specified minimum yield strength (SMYS), except for 10 feet of pipe on the Bechtelsville compressor discharge line that was tested to 90% SMYS. DEGT identified the waiver segments and the areas within each segment that have changed from Class 1 to Class 2 as follows:
DEGT requested that the waiver be immediately applicable to the specified areas within each of the waiver segments where the class location has changed. DEGT further requested that the waiver be applicable to any Class 1
DEGT presented the following justifications for its waiver request:
• Under its risk management program, DEGT has verified the integrity of the pipe in all four waiver segments by conducting in-line inspections (ILIs). DEGT first inspected the pipelines in 1986 using Tuboscope's conventional magnetic flux leakage (MFL) tool. Between 1996 and 2002, DEGT performed a second inspection of these lines using Tuboscope's conventional MFL tool and Tuboscope's high-resolution MFL tool.
• DEGT inspected and evaluated the condition of the pipe coating and evaluated the cathodic protection current demands on each of the pipelines. DEGT reported that the coatings were in good condition and that the cathodic protection systems were not experiencing excessive current demands.
• DEGT contends that the proposed alternative risk control activities would provide a margin of safety and environmental protection that equals or exceeds that of the measures required under 192.611.
• Granting the waiver would avoid the delivery interruptions, supply shortages, and costs associated with excavating and replacing the pipe in the specified areas.
• The proposed alternative risk control activities would benefit the entire length of the four waiver segments, as opposed to only the limited portions associated with the current class changes.
On January 15, 2004, RSPA/OPS published a notice in the
Based on DEGT's justifications and because DEGT will conduct alternative risk control activities, RSPA/OPS finds that a waiver is not inconsistent with pipeline safety. Therefore, DEGT's request for waiver of the requirements of 192.611 for changes from Class 1 to Class 2 within the Entriken, Perulack, Bernville, and Bechtelsville segments of Lines 12 and 19 is granted on the condition that DEGT complies with the following requirements and conducts the following activities on schedule:
1. In-line inspections must have been conducted on all site(s) covered by this waiver at least twice using a magnetic flux leakage (MFL) tool capable of detecting corrosion anomalies;
2. All actionable anomalies within the waiver site(s) must have either been remediated, or scheduled to be investigated and if necessary subsequently remediated, in accordance with ASME B31.8S and DEGT's Pipeline Repair Procedures.
3. For sites within the waiver segments changing from Class 1 to Class 2 in the future, DEGT must provide notification to RSPA/OPS prior to applying the waiver and a schedule of any remedial measures to be performed on future waiver sites must be submitted in advance to RSPA/OPS headquarters and the Eastern Regional Office;
4. For future sites covered by this waiver, DEGT must use the tools and techniques developed through the activities described in the waiver request and associated submissions involving the identification, classification, and possible remediation of dents;
5. The waiver sites must pass a hydrostatic test to a pressure of at least 125% of the MAOP of the pipeline. DEGT must make available to RSPA/OPS a report on all hydrostatic test failures experienced at this test pressure;
6. Subsequent in-line inspections for the waiver sites must be scheduled in accordance with the re-inspection criteria developed under Item No. 5 in Calendar Year 2004;
7. The waiver sites must be in compliance with ASME B31.8S criteria for stress corrosion cracking (SCC) site identification and site investigation/testing (including any additional criteria developed in conjunction with SCC activities under Item No. 7 in Calendar Year 2004);
8. All pipeline sites covered under this waiver must conform to the required maximum reassessment intervals specified in 192.939; and
9. DEGT must provide the RSPA/OPS' Eastern Region with sufficient notice to enable RSPA/OPS staff to attend and participate in all risk assessment activities.
Schedule of activities to maintain the pipeline integrity on the waiver segments—
1. Conduct a close-interval survey on one line in the Perulack segment to support the development of confirmatory direct assessment protocols;
2. Conduct a direct current voltage gradient (DCVG) survey on one line in the Perulack segment (same line as Item No. 1 above ) to support external corrosion direct assessment (ECDA) validations;
3. Conduct a high-resolution MFL tool run for the Bechtelsville segment, Line 12;
4. Conduct high-resolution geometry tool runs on the Entriken segment, Line 19; the Perulack segment, Line 19; and the Bechtelsville segment, Line 12;
5. Develop criteria and a decision tree for determination of in-line inspection (ILI) re-inspection interval;
6. Develop calibration and validation methodology and decision tree for ILI that incorporates API 1163 (currently under development);
7. Develop a SCC management plan consistent with ASME B31.8S that includes hydrostatic test criteria, site selection criteria, and SCC excavation criteria;
8. Develop an investigation strategy for topside dents and best practice responses to topside dents caused by third party damage;
9. Provide site and operating support for the Pipeline Research Council International, Inc. (PRCI) Compendium of Best Practices and Emerging Technologies for the prevention and detection of outside damage to pipeline with P-PIC that will develop a user guide for outside force damage technologies;
10. Develop a Web site accessible by RSPA/OPS on waiver-related sites and data. Provide public access to the website as needed to support the application of API RP 1162;
11. Deploy acoustic monitoring technology in conjunction with a GTI/Battelle research project at a site to be determined for a data gathering test period of one year;
12. Overlay the high-resolution MFL data with the high-resolution geometry tool run data on the Entriken segment, Line 19; the Perulack segment, Line 19; and the Bechtelsville segment, Line 12. Overlay available hydrostatic test data from the Bechtelsville segment Lines 12 and 19 with identified dents. Overlays will be used in an effort to refine dent remediation criteria; and
13. Develop criteria for safe in service investigation of dents.
In addition to the above requirements, DEGT will adhere to the following reporting requirements as a condition of this grant of waiver:
Within three months following approval of a class location waiver and annually thereafter, the operator will be required to report the following:
1. Define the economic benefit to the company. This should address both the cost avoided from not replacing the pipe as well as the added costs of the inspection program (required for the initial report only);
2. The results of any ILI or direct assessments performed within the inspection area containing the waiver location(s) during the previous year;
3. Any new integrity threats identified within the inspection area containing the waiver location(s) during the previous year;
4. Any encroachment in the inspection area including the waiver location(s), including new residences (by number) or areas of public congregation;
5. Any incidents associated with the inspection area containing the waiver location(s) that occurred during the previous year. (both reportable and non reportable);
6. Any leaks on the pipeline in the inspection area containing the waiver location(s) that occurred during the previous year. (both reportable and non reportable);
7. All repairs on the pipeline in the inspection area containing the waiver location(s) made during the previous year;
8. On-going damage prevention initiatives on the pipeline in the inspection area containing the waiver location(s) and a discussion on its success; and
9. Any mergers, acquisitions, transfers of assets, or other events affecting the regulatory responsibility of the company operating the pipeline to which the waiver applies.
10. To the extent possible, describe in the first annual report the benefit to the public in terms of energy availability. This should address the benefit of avoided disruptions as a consequence of pipe replacement and the benefit of maintaining system capacity.
49 App. U.S.C. 60118(c) and 2015; and 49 CFR 1.53.
10 a.m., August 31, 2004.
The Board's Hearing Room, Surface Transportation Board, 1925 K Street, NW., Washington, DC 20423.
The Board will meet to discuss among themselves the following agenda items. Although the conference is open for public observation, no public participation is permitted.
STB Finance Docket No. 27590 (Sub-No. 3),
STB Docket No. 42054,
A. Dennis Watson, Office of Congressional and Public Services, Telephone: (202) 565-1596 FIRS: 1-800-877-8339.
Columbia & Reading Railway Co. (CRRC), a noncarrier, has filed a verified notice of exemption under 49 CFR 1150.31 to acquire from Frank Sahd Salvage Center, Inc. (Sahd Salvage) approximately 2.5 miles of rail line, from milepost 39.3 in the Borough of Columbia to milepost 37.2 in West Hempfield Township in Lancaster County, PA. Sahd Salvage has agreed to transfer the rail line to CRRC so that it may develop common carrier rail operations, which will be provided by a to be determined third party. CRRC is a corporate affiliate of Sahd Salvage.
CRRC certifies that its projected annual revenues will not exceed those that would qualify it as a Class III rail carrier and that its annual revenues are not projected to exceed $5 million.
CRRC states that the parties intended to consummate the transaction on or about August 9, 2004, the effective date of the exemption (7 days after the exemption was filed).
If the notice contains false or misleading information, the exemption is void
An original and 10 copies of all pleadings, referring to STB Finance Docket No. 34534, must be filed with the Surface Transportation Board, 1925 K Street NW., Washington, DC 20423-0001. In addition, one copy of each pleading must be served on Jeffrey O. Moreno, Esq, 1920 N Street, NW., Suite 800, Washington, DC 20036.
Board decisions and notices are available on the Board's Web site at
By the Board, David M. Konschnik, Director, Office of Proceedings.
The Department of Treasury has submitted the following public information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Copies of the submission(s) may be obtained by calling the Treasury Bureau Clearance Officer listed. Comments regarding this information collection should be addressed to the OMB reviewer listed and to the Treasury Department Clearance Officer, Department of the Treasury, Room 11000, 1750 Pennsylvania Avenue, NW., Washington, DC 20220.
Written comments should be received on or before September 27, 2004 to be assured of consideration.
Internal Revenue Service, Treasury.
Notice of closed meeting of Art Advisory Panel.
Closed meeting of the Art Advisory Panel will be held in Washington, DC.
The meeting will be held September 22 and 23, 2004.
The closed meeting of the Art Advisory Panel will be held on September 22 and 23, 2004, in Room 4600E beginning at 9:30 a.m., Franklin Court Building, 1099 14th Street, NW., Washington, DC 20005.
Karen Carolan, C:AP:AS, 1099 14th Street, NW., Washington, DC 20005. Telephone (202) 694-1861 (not a toll free number).
Notice is hereby given pursuant to section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App., that a closed meeting of the Art Advisory Panel will be held on September 22 and 23, 2004, in Room 4600E beginning at 9:30 a.m., Franklin Court Building, 1099 14th Street, NW., Washington, DC 20005.
The agenda will consist of the review and evaluation of the acceptability of fair market value appraisals of works of art involved in Federal income, estate, or gift tax returns. This will involve the discussion of material in individual tax returns made confidential by the provisions of 26 U.S.C. 6103.
A determination as required by section 10(d) of the Federal Advisory Committee Act has been made that this meeting is concerned with matters listed in section 552b(c)(3), (4), (6), and (7), and that the meeting will not be open to the public.
In notice document 04-19117 beginning on page 51640 in the issue of August 20, 2004, make the following corrections:
1. On page 51640, in the third column, under the
2. On page 51641, in the second column, in the first line, “4232(2)(c)” should read, “4332(2)(c).”
In notice document 04-19116 beginning on page 51639 in the issue of Friday, August 20, 2004, make the following corrections:
1. On page 51639, in the third column, under
2. On the same page, in the same column, under the same heading, in the 10th line, “(213) 451-3811” should read “(213) 452-3811.”
In notice document 04-16086 beginning on page 43144 in the issue of Monday, July 19, 2004, correct the docket number in the document heading to read as set forth above.
Office of the Assistant Secretary for Community Planning and Development, HUD.
Notice.
This notice identifies unutilized, underutilized, excess, and surplus Federal property reviewed by HUD for suitability for possible use to assist the homeless.
Kathy Burruss, room 7266, Department of Housing and Urban Development, 451 Seventh Street, SW., Washington, DC 20410; telephone (202) 708-1234; TTY number for the hearing- and speech-impaired (202) 708-2565 (these telephone numbers are not toll-free), or call the toll-free Title V information line at 1-800-927-7588.
In accordance with 24 CFR part 581 and section 501 of the Stewart B. McKinney Homeless Assistance Act (42 U.S.C. 11411), as amended, HUD is publishing this notice to identify Federal buildings and other real property that HUD has reviewed for suitability for use to assist the homeless. The properties were reviewed using information provided to HUD by Federal landholding agencies regarding unutilized and underutilized buildings and real property controlled by such agencies or by GSA regarding its inventory of excess or surplus Federal property. This notice is also published in order to comply with the December 12, 1988, Court Order in
Properties reviewed are listed in this Notice according to the following categories: suitable/available, suitable/unavailable, suitable/to be excess, and unsuitable. The properties listed in the three suitable categories have been reviewed by the landholding agencies, and each agency has transmitted to HUD: (1) Its intention to make the property available for use to assist the homeless, (2) its intention to declare the property excess to the agency's needs, or (3) a statement of the reasons that the property cannot be declared excess or made available for use as facilities to assist the homeless.
Properties listed as suitable/available will be available exclusively for homeless use for a period of 60 days from the date of this Notice. Where property is described as for “off-site use only” recipients of the property will be required to relocate the building to their own site at their own expense. Homeless assistance providers interested in any such property should send a written expression of interest to HHS, addressed to Heather Ranson, Division of Property Management, Program Support Center, HHS, room 5B-17, 5600 Fishers Lane, Rockville, MD 20857; (301) 443-2265. (This is not a toll-free number.) HHS will mail to the interested provider an application packet, which will include instructions for completing the application. In order to maximize the opportunity to utilize a suitable property, providers should submit their written expressions of interest as soon as possible. For complete details concerning the processing of applications, the reader is encouraged to refer to the interim rule governing this program, 24 CFR part 581.
For properties listed as suitable/to be excess, that property may, if subsequently accepted as excess by GSA, be made available for use by the homeless in accordance with applicable law, subject to screening for other Federal use. At the appropriate time, HUD will publish the property in a notice showing it as either suitable/available or suitable/unavailable.
For properties listed as suitable/unavailable, the landholding agency has decided that the property cannot be declared excess or made available for use to assist the homeless, and the property will not be available.
Properties listed as unsuitable will not be made available for any other purpose for 20 days from the date of this notice. Homeless assistance providers interested in a review by HUD of the determination of unsuitability should call the toll free information line at 1-800-927-7588 for detailed instructions or write a letter to Mark Johnston at the address listed at the beginning of this notice. Included in the request for review should be the property address (including zip code), the date of publication in the
For more information regarding particular properties identified in this notice (
Army
Bldg. 2276
Location: U101B, U101C, U507B, U557A
Securities and Exchange Commission.
Final rule; request for comments on Paperwork Reduction Act burden estimates.
The Securities and Exchange Commission is adopting amendments to its forms under the Securities Act of 1933, the Securities Exchange Act of 1934, and the Investment Company Act of 1940 to improve the disclosure provided by registered management investment companies regarding their portfolio managers. The amendments extend the existing requirement that a registered management investment company provide basic information in its prospectus regarding its portfolio managers to include the members of management teams. The amendments also require a registered management investment company to disclose additional information about its portfolio managers, including other accounts that they manage, compensation structure, and ownership of securities in the investment company.
Comments may be submitted by any of the following methods:
• Use the Commission's
• Send an e-mail to
• Use the Federal eRulemaking Portal (
• Send paper comments in triplicate to Jonathan G. Katz, Secretary, Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC 20549-0609.
All submissions should refer to File Number S7-12-04. This file number should be included on the subject line if e-mail is used. To help us process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site (
Sanjay Lamba, Attorney, or Christopher P. Kaiser, Branch Chief, Office of Disclosure Regulation, Division of Investment Management, (202) 942-0721, at the Securities and Exchange Commission, 450 Fifth Street, NW., Washington, DC 20549-0506.
The Securities and Exchange Commission (“Commission”) is adopting amendments to Form N-1A,
Registered management investment companies (“funds”)
Recently, several areas of concern have been identified with respect to fund portfolio managers. In particular, concerns have been raised regarding the following:
• The absence of disclosure about:
◦ The individual members of portfolio management teams;
◦ The compensation of portfolio managers; and
◦ Portfolio managers' holdings in the funds that they manage; and
• Potential conflicts of interest between the interests of shareholders in a fund that a portfolio manager oversees, and the interests of other clients and investment vehicles, such as hedge funds and pension funds, that a portfolio manager may also oversee.
In order to address these concerns, earlier this year the Commission proposed rules intended to provide greater transparency regarding portfolio managers, their incentives in managing a fund, and potential conflicts of interest (“Proposing Release”). These proposals were designed to assist investors in evaluating fund management and making investment decisions.
The Commission received 34 comment letters relating to the proposals. The commenters generally supported the proposals, although some expressed concerns regarding portions of the disclosure or suggested changes. Today, the Commission is adopting these proposals, with modifications to address commenters' concerns. The amendments that the Commission is adopting will:
• Require a fund to identify in its prospectus each member of a committee, team, or other group of persons that is jointly and primarily responsible for the day-to-day management of the fund's portfolio (or, in the case of a team with more than five such members, the five members with the most significant responsibility for the day-to-day management of the fund's portfolio);
• Require a fund to provide information in its Statement of Additional Information (“SAI”)
• Require a fund to disclose in its SAI the structure of, and the method used to determine, the compensation of each portfolio manager;
• Require a fund to disclose in its SAI each portfolio manager's ownership of securities in the fund; and
• Require a closed-end fund to provide disclosure regarding its portfolio managers in its reports on Form N-CSR.
The Commission is adopting, with modifications to address commenters' concerns, proposed amendments to Forms N-1A and N-2, the registration forms for mutual funds and closed-end funds, that will require those funds to identify in their prospectuses each member of a committee, team, or other group of persons associated with the fund or its investment adviser that is jointly and primarily responsible for the day-to-day management of the fund's portfolio.
We are also adopting amendments to Form N-3, the registration form for insurance company managed separate accounts that issue variable annuity contracts, to require disclosure regarding portfolio managers, including members of portfolio management teams, similar to the disclosure that will be required by Forms N-1A and N-2.
Commenters generally supported the Commission's proposal to require improved disclosure about members of portfolio management teams. However, several commenters expressed concern that, while a requirement to identify the members of a portfolio management team may be appropriate for teams that consist of a relatively small number of members, the disclosure could become lengthy and less meaningful in the case of larger teams. Some of these commenters noted that some portfolio management teams consist of both portfolio managers, who have authority to make management decisions, and analysts and other junior members, who have no decision-making authority. These commenters argued that the proposed disclosure requirement could be interpreted to require disclosure of every such junior member of a management team, which would result in lengthy disclosure that would have to be updated frequently, whenever the composition of the team changed. In addition, some commenters argued that a requirement to identify all members of a portfolio management team could inhibit an adviser's ability to change the composition of a team.
We note that, under the amendments we are adopting, disclosure is only required with respect to members of a management team who are jointly and primarily responsible for the day-to-day management of the fund's portfolio. To the extent that a fund is managed by a committee, team, or other group that includes additional members who are not jointly and primarily responsible for day-to-day management, identification of these individuals is not required. Thus, if a fund has a management team that includes analysts who make securities recommendations with respect to the portfolio, but do not have decision-making authority, these individuals would not have to be identified, unless they are jointly and primarily responsible for day-to-day management of the fund's portfolio. An analyst could be jointly and primarily responsible for day-to-day management if, for example, the individual who has decision-making authority over the fund's portfolio routinely adopts the analyst's recommendations.
We are, however, modifying our proposal in response to the commenters' concerns to provide that if more than five persons are jointly and primarily responsible for the day-to-day management of a fund's portfolio, the fund need only provide the required information for the five persons with the most significant responsibility.
The determination of the members of a portfolio management team who are jointly and primarily responsible for the day-to-day management of a fund's portfolio will depend on the facts and circumstances of the particular fund. For example, in the case of a fund with a large management team, where a single “lead member” is responsible for implementing and monitoring the overall portfolio management of the
The amendments also require a fund to provide a brief description of each member's role on the management team (
We are adopting, with several modifications to address commenters' concerns, amendments that require a fund to provide disclosure in its SAI regarding other accounts for which the fund's portfolio manager is primarily responsible for the day-to-day portfolio management.
This disclosure requirement, as well as the disclosure requirements discussed below regarding compensation structure and ownership of fund securities,
As adopted, the amendments require a fund to disclose the number of other accounts managed by a portfolio manager, and the total assets in the accounts, within each of the following categories: Registered investment companies; other pooled investment vehicles; and other accounts.
The amendments, as adopted, also require a fund to describe any material conflicts of interest that may arise in connection with the portfolio manager's management of the fund's investments, on the one hand, and the investments of the other accounts, on the other.
We are not adopting our proposal to require a fund to include a description of the policies and procedures used by the fund or its investment adviser to address conflicts of interest.
Finally, we requested comment in the Proposing Release on whether to prohibit portfolio managers of funds from managing certain types of accounts, such as hedge funds. We have determined not to do so, because we agree with several commenters that a prohibition could reduce investors' access to talented portfolio managers and could have a particularly disruptive effect on smaller investment management firms that may not have the resources to maintain separate staffs for different types of accounts. We believe that the disclosure of other accounts managed and material conflicts of interest, together with the requirement in the compliance rules for policies and procedures to address conflicts, is a preferable approach to addressing conflicts of interest arising from side-by-side management of multiple accounts.
We are adopting, with modifications to address commenters' concerns, a requirement that a fund provide disclosure in its SAI regarding the structure of, and the method used to determine, the compensation of its portfolio managers.
The amendments require a description of the structure of, and the method used to determine, the compensation received by a fund's portfolio manager from the fund, its investment adviser, or any other source with respect to management of the fund and any other account included by the fund in response to the disclosure requirement described above regarding other accounts managed by the portfolio manager.
For purposes of the disclosure requirement, compensation includes, without limitation, salary, bonus, deferred compensation, and pension and retirement plans and arrangements, whether the compensation is cash or non-cash.
For each type of compensation (
We have modified the proposal in order to elicit better disclosure of the basis on which a portfolio manager is compensated. We have made these changes based on commenters' suggestions that a fund should be required to disclose the specific metrics used to measure performance. We believe that where compensation is based on criteria such as performance,
We are adopting a requirement that a fund disclose in its SAI the securities ownership in the fund of each portfolio manager who is required to be identified in the fund's prospectus.
Commenters generally supported the goal of this proposal. Several commenters argued, however, that while the level of a portfolio manager's securities ownership may be an indicator of the manager's confidence in the fund's investment strategy where the manager owns shares in the fund, it does not necessarily follow that a manager who owns few or no securities has any less confidence or is any less concerned about the fund's performance. We continue to believe, however, that a portfolio manager's ownership in a fund provides a direct indication of his or her alignment with the interests of shareholders in that fund. While a manager could have reasons for not holding shares of a specific fund that are unrelated to the manager's lack of confidence in the fund,
We have modified our proposed disclosure requirement with respect to securities ownership significantly, to address concerns raised by commenters. In particular, we have limited the requirement to a portfolio manager's ownership of equity securities in the fund itself.
The disclosure requirement we are adopting applies to fund securities beneficially owned by a portfolio manager.
Our proposal also would have required disclosure of securities owned by a portfolio manager's immediate family members, and would have defined “immediate family member” for this purpose as a person's spouse; child residing in the person's household (including step and adoptive children); and any dependent of the person, as defined in section 152 of the Internal Revenue Code.
We are adopting, as proposed, a requirement that funds disclose portfolio managers' ownership of securities in the fund using the
We continue to believe, on balance, that requiring disclosure of securities owned using a maximum dollar range of “over $1,000,000” is appropriate. Disclosure of the dollar range of securities owned by a portfolio manager, rather than precise dollar holdings, is intended to provide shareholders with significant information to use in evaluating whether a manager's interests are aligned with their own, while protecting managers' legitimate privacy interests.
The required information regarding other accounts managed by a portfolio manager, compensation structure, and ownership of fund securities must be provided as of the end of the fund's most recently completed fiscal year.
Several commenters suggested that we should require the information regarding other accounts managed by a portfolio manager, compensation structure, and ownership of fund securities as of the most recent calendar year-end, rather than the fund's most recent fiscal year-end. These commenters noted that a fund complex frequently has multiple funds managed by the same portfolio manager, and argued that requiring information as of the most recent fiscal year-end would complicate the administrative burden of compiling the required disclosure for a portfolio manager who manages several funds with different fiscal year-ends. Another commenter, however, supported requiring the information as of the most recent fiscal year-end, arguing that this approach would strike a reasonable balance between timeliness and practicality. We are adopting the requirement as proposed, because we believe that requiring the disclosure to be provided as of calendar year-end would, in many instances, result in investors receiving excessively stale information. For example, if a fund updated its prospectus on December 1 and provided information about its portfolio managers as of the most recent calendar year-end, investors would receive information that is already 11 months old at the time of the update. We note that other modifications we are making to the amendments, in particular, limiting the disclosure of a portfolio manager's securities ownership to ownership of securities in the fund itself, will significantly reduce the burden to funds of preparing this disclosure.
We are removing the current provision in Form N-1A that excludes a fund that has as its investment objective replication of the performance of an index from the requirement to identify and provide disclosure regarding its portfolio managers.
In order to assist investors in finding the additional information about portfolio managers that is required in the SAI, we are adopting amendments that require a fund to state in its prospectus that the SAI provides this information.
We are also adopting the proposed requirement that the back cover page of a mutual fund's prospectus state whether the fund makes available its SAI and annual and semi-annual reports, free of charge, on or through its Web site at a specified Internet
Because closed-end funds do not offer their shares continuously, and are therefore generally not required to maintain an updated SAI to meet their obligations under the Securities Act of 1933,
The disclosure in Form N-CSR with respect to the name, title, length of service, and business experience of a portfolio manager is required to be current as of the date of filing of the report, and the disclosure regarding other accounts managed, compensation structure, and fund securities ownership generally is required to be current as of the end of the fund's most recently completed fiscal year.
The effective date of the amendments is October 1, 2004. All initial registration statements on Forms N-1A, N-2, and N-3, and all post-effective amendments that are annual updates to effective registration statements on these forms, filed on or after February 28, 2005, must include the disclosure required by the amendments. Moreover, all post-effective amendments that add a new series, filed on or after February 28, 2005, must comply with the amendments with respect to the new series. Every annual report by a closed-end fund on Form N-CSR filed for a fiscal year ending on or after December 31, 2005, and every semi-annual report by a closed-end fund on Form N-CSR filed after the first such annual report, must include the disclosure required by the amendments. Based on the comments and the changes we have made to the proposed requirements, we believe that this will provide adequate time for funds to compile and review the information that must be disclosed.
As explained in the Proposing Release, certain provisions of the amendments contain “collection of information” requirements within the meaning of the Paperwork Reduction Act of 1995 [44 U.S.C. 3501,
Form N-1A (OMB Control No. 3235-0307), Form N-2 (OMB Control No. 3235-0026), and Form N-3 (OMB Control No. 3235-0316) were adopted pursuant to Section 8(a) of the Investment Company Act [15 U.S.C. 80a-8(a)] and Section 5 of the Securities Act [15 U.S.C. 77e]. Form N-CSR (OMB Control No. 3235-0570) was adopted pursuant to Section 30 of the Investment Company Act [15 U.S.C. 80a-29] and Sections 13 and 15(d) of the Exchange Act [15 U.S.C. 78m and 78o(d)].
We published notice soliciting comments on the collection of information requirements in the Proposing Release and submitted these proposed collections of information to the Office of Management and Budget (“OMB”) for review in accordance with 44 U.S.C. 3507(d) and 5 CFR 1320.11.
The amendments to Forms N-1A, N-2, and N-3 adopted in this release require funds to provide improved disclosure regarding their portfolio managers in fund prospectuses and SAIs. The amendments also amend Form N-CSR to require similar disclosure for closed-end funds in reports on Form N-CSR. The paperwork burden estimates for the amendments, described below, represent the estimated total burden annualized over a three-year period. We expect that
Form N-1A, including the amendments, contains collection of information requirements. The likely respondents to this information collection are open-end funds registering with the Commission. Compliance with the disclosure requirements of Form N-1A is mandatory. Responses to the disclosure requirements are not confidential.
We estimate that, on an annual basis, registrants file initial registration statements on Form N-1A covering 483 portfolios, and file post-effective amendments on Form N-1A covering 6,542 portfolios. The current hour burden for Form N-1A is 1,142,296 hours.
In addition to reducing the estimate of internal burden hours to take into account modifications to the proposal, we are adding an estimate of external costs to reflect the possibility that funds will engage outside counsel to review the new disclosure and provide related legal services. We estimate that, as a result of the amendments, funds will incur an additional 1 hour of outside counsel time per portfolio per filing of an initial registration statement on Form N-1A and will incur an additional 0.5 hours of outside counsel time per portfolio per filing of a post-effective amendment on Form N-1A. Thus, we estimate that the incremental external costs for Form N-1A resulting from the amendments will be $1,126,200 ((483 portfolios filing initial registration statements × 1 hour per portfolio + 6,542 portfolios filing post-effective amendments × 0.5 hours per portfolio) × $300 per hour).
Form N-2, including the amendments, contains collection of information requirements. The likely respondents to this information collection are closed-end funds registering with the Commission. Compliance with the disclosure requirements of Form N-2 is mandatory. Responses to the disclosure requirements are not confidential.
We estimate that, on an annual basis, 234 closed-end funds will file initial registration statements on Form N-2 and 38 closed-end funds will file post-effective amendments on Form N-2. The current hour burden for Form N-2 is 134,301 hours. In light of the modifications we are making to the proposal, we now estimate that the amendments will increase the hour burden per filing of an initial registration statement on Form N-2 by 6 hours and the hour burden per filing of a post-effective amendment on Form N-2 by 2 hours.
As with Form N-1A above, we estimate that, as a result of the amendments, funds will incur an additional 1 hour of outside counsel time per filing of an initial registration statement on Form N-2 and will incur an additional 0.5 hours of outside counsel time per filing of a post-effective amendment on Form N-2. Thus, we estimate that the incremental external costs for Form N-2 resulting from the amendments will be $75,900 ((1 hour per fund × 234 funds + 0.5 hours per fund × 38 funds) × $300).
Form N-3, including the amendments, contains collection of information requirements. The likely respondents to this information collection are separate accounts, organized as management investment companies offering variable annuities, registering with the Commission on Form N-3. Compliance with the disclosure requirements of Form N-3 is mandatory. Responses to the disclosure requirements are not confidential.
The Commission estimates that, on an annual basis, initial registration statements covering 3 portfolios are filed on Form N-3 and post-effective amendments covering 35 portfolios are filed on Form N-3. The current hour burden for Form N-3 is 34,756 hours. In light of the modifications we are making to the proposal, we now estimate that the amendments will increase the hour burden per portfolio per filing of an initial registration statement on Form N-3 by 6 hours and the hour burden per portfolio per filing of a post-effective amendment on Form N-3 by 2 hours.
As with Forms N-1A and N-2 above, we estimate that, as a result of the amendments, funds will incur an additional 1 hour of outside counsel time per portfolio per filing of an initial registration statement on Form N-3 and will incur an additional 0.5 hours of outside counsel time per portfolio per filing of a post-effective amendment on Form N-3. Thus, we estimate that the incremental external costs for Form N-3 resulting from the amendments will be $6,150 ((1 hour × 3 portfolios) + (0.5 hours × 35 portfolios) × $300).
Form N-CSR, including the amendments, contains collection of information requirements. The respondents to this information collection will be closed-end funds subject to rule 30e-1 under the Investment Company Act registering with the Commission on Form N-2. Compliance with the disclosure requirements of Form N-CSR is mandatory. Responses to the disclosure requirements are not confidential.
We estimate that, on an annual basis, 733 closed-end funds registered on Form N-2 file reports on Form N-CSR.
We estimate that, as a result of the amendments, funds will incur an additional 1 hour of outside counsel time per filing of an annual report on Form N-CSR and will incur an additional 0.5 hours of outside counsel time per filing of a semi-annual report on Form N-CSR. Thus, we estimate that the incremental external costs for Form N-CSR resulting from the amendments will be $329,850 ((1 hour per fund × 733 closed-end funds + 0.5 hours per fund × 733 closed-end funds) × $300).
The Commission previously submitted burden estimates to OMB for the collections of information with respect to Forms N-1A and N-CSR which have not yet been approved. The amendments as adopted result in modifications to the burden hours associated with these collections of information. Because the burden estimates under review at OMB do not reflect the modifications made by the Commission in this release, we are submitting new estimates to OMB with respect to Forms N-1A and N-CSR and requesting comments on these new estimates. The Commission requests comment in order to:
• Evaluate whether the proposed collections of information are necessary for the proper performance of the functions of the Commission, including whether the information has practical utility;
• Evaluate the accuracy of the Commission's estimates of the burden of the proposed collections of information;
• Determine whether there are ways to enhance the quality, utility, and clarity of the information to be collected; and
• Evaluate whether there are ways to minimize the burden of the collections of information on the respondents, including through the use of automated collection techniques or other forms of information technology.
Persons submitting comments on the collection of information requirements should direct the comments to the Office of Management and Budget, Attention: Desk Officer for the Securities and Exchange Commission, Office of Information and Regulatory Affairs, Room 10102, New Executive Office Building, Washington, DC 20503, and should send a copy to Jonathan G. Katz, Secretary, Securities and Exchange Commission, 450 5th Street, NW., Washington, DC 20549, with reference to File No. S7-12-04. Requests for materials submitted to OMB by the Commission with regard to this collection of information should be in writing, refer to File No. S7-12-04, and be submitted to the Securities and Exchange Commission, Office of Filing and Information Services, 450 Fifth Street, NW., Washington, DC 20549-0609. OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this release. Consequently, a comment to OMB is best assured of having its full effect if OMB receives it within 30 days after publication of this release.
The Commission is sensitive to the costs and benefits imposed by its rules. Our amendments will require funds to provide enhanced disclosure about their portfolio managers. Specifically, the amendments will:
• Require a fund to identify in its prospectus each member of a committee, team, or other group of persons that is jointly and primarily responsible for the day-to-day management of the fund's portfolio (or in the case of a team with more than five such members, the five members with the most significant responsibility for the day-to-day management of the fund's portfolio);
• Require a fund to provide information in its SAI regarding other accounts managed by any of its portfolio managers, including a description of material conflicts of interest that may arise in connection with simultaneously managing the fund and the other accounts;
• Require a fund to disclose in its SAI the structure of, and the method used to determine, the compensation of each portfolio manager;
• Require a fund to disclose in its SAI each portfolio manager's ownership of securities in the fund; and
• Require a closed-end fund to provide parallel disclosure regarding its portfolio managers in its reports on Form N-CSR.
These amendments are intended to provide greater transparency regarding portfolio managers, their incentives in managing a fund, and the potential conflicts of interest that may arise when they or the adviser that employs them also manages other investment vehicles.
In the Proposing Release, we provided an analysis of the costs and benefits of the proposed amendments, and we requested comments.
The enhanced disclosure regarding portfolio managers that will be required under our amendments will benefit investors in several ways. First, enhanced disclosure regarding portfolio managers who are members of management teams will help investors better evaluate the identity, background, and experience of fund management in cases where the fund is managed using a team approach. Second, requiring a fund to provide disclosure regarding other accounts for which its portfolio managers are primarily responsible for day-to-day portfolio management will enable investors to assess the conflicts of interest to which a portfolio manager may be subject as a result of managing the fund and other portfolios, such as hedge funds. Third, requiring a fund to provide disclosure regarding the structure of, and method used to determine, the compensation of its portfolio managers will help investors better understand a portfolio manager's incentives in running a fund, and will also shed light on possible conflicts of interest that may arise when a portfolio manager manages other accounts. Finally, requiring a fund to disclose the ownership of fund securities of each of its portfolio managers should help investors to assess the extent to which the portfolio manager's interests are aligned with theirs.
The amendments impose new requirements on funds to provide enhanced disclosure regarding their portfolio managers. We estimate that complying with these new disclosure requirements will entail a relatively small financial burden. Much of the information required regarding a fund's portfolio managers, including basic information about their identity and business experience, and information about other accounts that they manage and their compensation structure, should be readily available to a fund's investment adviser. We note that our recently adopted code of ethics rules for investment advisers require portfolio managers to report to the investment adviser information on their securities holdings, including securities in the fund, on an annual basis, and to report information on their securities transactions each calendar quarter.
These costs may include both internal costs (for attorneys and other non-legal staff of a fund, such as computer programmers, to prepare and review the required disclosure) and external costs (for printing and typesetting of the disclosure and outside legal counsel). For purposes of the Paperwork Reduction Act, we have estimated that the new disclosure requirements will add 19,749 hours to the internal burden of completing Forms N-1A, N-2, N-3 and N-CSR.
We expect that the external costs relating to the physical delivery of the disclosure required by the amendments, such as printing, typesetting, and mailing, will be minimal, because this disclosure will be required in a fund's SAI (and in the case of a closed-end fund, on Form N-CSR also). The SAI is typically not typeset, and is only required to be provided to shareholders upon request. Similarly, because the disclosure in Form N-CSR for closed-end funds is not required to be delivered to shareholders, we estimate that the external costs of this disclosure will be minimal as well.
Section 23(a)(2) of the Exchange Act requires us, when adopting rules under the Exchange Act, to consider the impact that any new rule will have on competition.
The amendments are intended to provide greater transparency for fund
Although, as noted above, we believe that the amendments will benefit investors, the magnitude of the effect of the amendments on efficiency and competition, and the extent to which they will be offset by the costs of the amendments, are difficult to quantify. We note that most funds are currently required to provide disclosure in their prospectuses regarding the identity and background of their portfolio managers.
This Final Regulatory Flexibility Analysis (“Analysis”) has been prepared in accordance with 5 U.S.C. 603. It relates to the Commission's amendments to Forms N-1A, N-2, and N-3 under the Securities Act and the Investment Company Act, and to Form N-CSR under the Investment Company Act and the Exchange Act, that will require funds to provide improved disclosure about their portfolio managers. We published in the release proposing these amendments an Initial Regulatory Flexibility Analysis (“IRFA”), which we prepared in accordance with 5 U.S.C. 603.
Sections I and II of this Release describe the reasons for and objectives of the form amendments. As we discuss in detail above, these amendments are designed to require a fund to provide improved information regarding its portfolio managers, in order to better help investors evaluate their background, incentives in managing the fund, and potential conflicts of interest.
In the IRFA for the proposed amendments, we requested comment on any aspect of the IRFA, including the number of small entities that would be affected by the proposed amendments, the likely impact of the proposal on small entities, the nature of any impact, and providing any empirical data supporting the extent of the impact. We received no comment letters addressing this section.
For purposes of the Regulatory Flexibility Act, an investment company is a small entity if it, together with other investment companies in the same group of related investment companies, has net assets of $50 million or less as of the end of its most recent fiscal year.
The amendments will require a fund to identify and provide basic information in its prospectus regarding each member of a team responsible for managing the fund's portfolio. In addition, a fund will be required to provide additional disclosure in its SAI about its portfolio managers, including other accounts they manage, compensation structure, and ownership of fund securities. A closed-end fund will also be required to provide this disclosure in its reports on Form N-CSR.
The Commission estimates some one-time formatting and ongoing costs and burdens that will be imposed on all funds, including funds that are small entities. We note, however, that in many cases mutual funds and closed-end funds currently provide disclosure in their prospectuses about their portfolio managers, including their names, titles, length of service, and business experience. For purposes of the Paperwork Reduction Act, we have estimated that the new disclosure requirements will increase the hour burden of filings on Forms N-1A, N-2, N-3, and N-CSR by 19,749 hours annually, or $1,654,374.
We expect that the external costs of providing the additional disclosure relating to a fund's portfolio managers, including other accounts they manage, compensation structure, and ownership of fund securities, will be minimal, because this disclosure will be required in a fund's SAI (and in the case of a closed-end fund, on Form N-CSR also). The SAI is typically not typeset, and is only required to be provided to shareholders upon request. Similarly, because the disclosure in Form N-CSR for closed-end funds is not required to be delivered to shareholders, we estimate that the external costs of this disclosure on Form N-CSR will be minimal as well.
The Regulatory Flexibility Act directs us to consider significant alternatives that would accomplish our stated objective, while minimizing any significant adverse impact on small issuers. In connection with the amendments, the Commission considered the following alternatives: (i) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (ii) the clarification, consolidation, or simplification of compliance and reporting requirements under the amendments for small entities; (iii) the use of performance rather than design standards; and (iv) an exemption from coverage of the amendments, or any part thereof, for small entities.
The Commission believes at the present time that special compliance or reporting requirements for small entities, or an exemption from coverage
We have endeavored through the amendments to minimize the regulatory burden on all funds, including small entities, while meeting our regulatory objectives. For example, we have modified our proposal to eliminate the proposed requirement to describe policies and procedures related to conflicts of interest in the SAI, and to limit the disclosure of a portfolio manager's ownership of securities to securities of the fund that he or she manages. In addition, we have modified our proposed compliance date to allow funds additional time to provide the required disclosure in their initial registration statements and post-effective amendments. Small entities should benefit from the Commission's reasoned approach to the amendments to the same degree as other investment companies. Further clarification, consolidation, or simplification of the amendments for funds that are small entities would be inconsistent with the Commission's concern for investor protection. Finally, we do not consider using performance rather than design standards to be consistent with our statutory mandate of investor protection in the present context. Based on our past experience, we believe that the disclosure will be more useful to investors if there are enumerated informational requirements.
The Commission is adopting amendments to Forms N-1A, N-2, and N-3 pursuant to authority set forth in sections 5, 6, 7, 10, and 19(a) of the Securities Act [15 U.S.C. 77e, 77f, 77g, 77j, and 77s(a)] and sections 8, 24(a), 30, and 38 of the Investment Company Act [15 U.S.C. 80a-8, 80a-24(a), 80a-29, and 80a-37]. The Commission is also adopting amendments to Form N-CSR pursuant to authority set forth in sections 10(b), 13, 15(d), 23(a), and 36 of the Exchange Act [15 U.S.C. 78j(b), 78m, 78o(d), 78w(a), and 78mm] and sections 8, 24(a), 30, and 38 of the Investment Company Act [15 U.S.C. 80a-8, 80a-24(a), 80a-29, and 80a-37].
Reporting and recordkeeping requirements, Securities.
Investment companies, Reporting and recordkeeping requirements, Securities.
15 U.S.C. 77f, 77g, 77h, 77j, 77s, 77z-2, 77sss, 78c, 78
15 U.S.C. 78a
15 U.S.C. 80a-1
15 U.S.C. 77f, 77g, 77h, 77j, 77s, 78c(b), 78
The additions and revisions are to read as follows:
The text of Form N-1A does not, and these amendments will not, appear in the Code of Federal Regulations.
(b)
(1) A statement that the SAI includes additional information about the Fund, and a statement to the following effect:
Additional information about the Fund's investments is available in the Fund's annual and semi-annual reports to shareholders. In the Fund's annual report, you will find a discussion of the market conditions and investment strategies that significantly affected the Fund's performance during its last fiscal year.
Explain that the SAI and the Fund's annual and semi-annual reports are available, without charge, upon request, and explain how shareholders in the Fund may make inquiries to the Fund. Provide a toll-free (or collect) telephone number for investors to call: To request the SAI; to request the Fund's annual report; to request the Fund's semi-annual report; to request other information about the Fund; and to make shareholder inquiries. Also, state whether the Fund makes available its SAI and annual and semi-annual reports, free of charge, on or through the Fund's Web site at a specified Internet address. If the Fund does not make its SAI and shareholder reports available in this manner, disclose the reasons why it does not do so (including, where applicable, that the Fund does not have an Internet Web site).
1. A Fund may indicate, if applicable, that the SAI, annual and semi-annual reports, and other information are available by E-mail request.
(a) * * *
(2)
1. This requirement does not apply to a Money Market Fund.
2. If a committee, team, or other group of persons associated with the Fund or an investment adviser of the Fund is jointly and primarily responsible for the day-to-day management of the Fund's portfolio, information in response to this Item is required for each member of such committee, team, or other group. For each such member, provide a brief description of the person's role on the committee, team, or other group (
(a)
(1) The Portfolio Manager's name;
(2) The number of other accounts managed within each of the following categories and the total assets in the accounts managed within each category:
(A) Registered investment companies;
(B) Other pooled investment vehicles; and
(C) Other accounts.
(3) For each of the categories in paragraph (a)(2) of this Item, the number of accounts and the total assets in the accounts with respect to which the advisory fee is based on the performance of the account; and
(4) A description of any material conflicts of interest that may arise in connection with the Portfolio Manager's management of the Fund's investments, on the one hand, and the investments of the other accounts included in response to paragraph (a)(2) of this Item, on the other. This description would include, for example, material conflicts between the investment strategy of the Fund and the investment strategy of other accounts managed by the Portfolio Manager and material conflicts in allocation of investment opportunities between the Fund and other accounts managed by the Portfolio Manager.
1. Provide the information required by this paragraph as of the end of the Fund's most recently completed fiscal year, except that, in the case of an initial registration statement or an update to the Fund's registration statement that discloses a new Portfolio Manager, information with respect to any newly identified Portfolio Manager must be provided as of the most recent practicable date. Disclose the date as of which the information is provided.
2. If a committee, team, or other group of persons that includes the Portfolio Manager is jointly and primarily responsible for the day-to-day management of the portfolio of an account, include the account in responding to paragraph (a) of this Item.
(b)
1. Provide the information required by this paragraph as of the end of the Fund's most recently completed fiscal year, except that, in the case of an initial registration statement or an update to the Fund's registration statement that discloses a new Portfolio Manager, information with respect to any newly identified Portfolio Manager must be provided as of the most recent practicable date. Disclose the date as of which the information is provided.
2. Compensation includes, without limitation, salary, bonus, deferred compensation, and pension and retirement plans and arrangements, whether the compensation is cash or non-cash. Group life, health, hospitalization, medical reimbursement, relocation, and pension and retirement plans and arrangements may be omitted, provided that they do not discriminate in scope, terms, or operation in favor of the Portfolio Manager or a group of employees that includes the Portfolio Manager and are available generally to all salaried employees. The value of compensation is not required to be disclosed under this Item.
3. Include a description of the structure of, and the method used to determine, any compensation received by the Portfolio Manager from the Fund, the Fund's investment adviser, or any other source with respect to management of the Fund and any other accounts included in the response to paragraph (a)(2) of this Item. This description must clearly disclose any differences between the method used to determine the Portfolio Manager's compensation with respect to the Fund and other accounts,
(c)
1. Provide the information required by this paragraph as of the end of the Fund's most recently completed fiscal year, except that, in the case of an initial registration statement or an update to the Fund's registration statement that discloses a new Portfolio Manager, information with respect to any newly identified Portfolio Manager must be provided as of the most recent practicable date. Specify the valuation date.
2. Determine “beneficial ownership” in accordance with rule 16a-1(a)(2) under the Exchange Act (17 CFR 240.16a-1(a)(2)).
The additions and revisions are to read as follows:
The text of Form N-2 does not, and these amendments will not, appear in the Code of Federal Regulations.
1. * * *
d. A statement that (A) The prospectus sets forth concisely the information about the Registrant that a prospective investor ought to know before investing; (B) the prospectus should be retained for future reference; and (C) additional information about the Registrant has been filed with the Commission and is available upon written or oral request and without charge. (This statement should explain how to obtain the SAI, whether any of it has been incorporated by reference into the prospectus, and where the table of contents of the SAI appears in the prospectus. This statement should also explain how to obtain the Registrant's annual and semi-annual reports to shareholders. Provide a toll-free (or collect) telephone number for investors to call: to request the SAI; to request the Registrant's annual report; to request the Registrant's semi-annual report; to request other information about the Registrant; and to make shareholder inquiries. Also state whether the Registrant makes available its SAI and annual and semi-annual reports, free of charge, on or through the Registrant's Web site at a specified Internet address. If the Registrant does not make its SAI and shareholder reports available in this manner, disclose the reasons why it does not do so (including, where applicable, that the Registrant does not have an Internet Web site.) Also include the information that the Commission maintains an Internet Web site (
1. * * *
c.
If a committee, team, or other group of persons associated with the Registrant or an investment adviser of the Registrant is jointly and primarily responsible for the day-to-day management of the Registrant's portfolio, information in response to this Item is required for each member of such committee, team, or other group. For each such member, provide a brief description of the person's role on the committee, team, or other group (
1.
a. The Portfolio Manager's name;
b. The number of other accounts managed within each of the following categories and the total assets in the accounts managed within each category:
(1) Registered investment companies;
(2) Other pooled investment vehicles; and
(3) Other accounts.
c. For each of the categories in Item 21.1.b., the number of accounts and the total assets in the accounts with respect to which the advisory fee is based on the performance of the account; and
d. A description of any material conflicts of interest that may arise in connection with the Portfolio Manager's management of the Registrant's investments, on the one hand, and the investments of the other accounts included in response to Item 21.1b., on the other. This description would include, for example, material conflicts between the investment strategy of the Registrant and the investment strategy of other accounts managed by the Portfolio Manager and material conflicts in allocation of investment opportunities between the Registrant and other accounts managed by the Portfolio Manager.
1. Provide the information required by Item 21.1 as of the end of the Registrant's most recently completed fiscal year, except that, in the case of an initial registration statement or an update to the Registrant's registration statement that discloses a new Portfolio Manager, information with respect to any newly identified Portfolio Manager must be provided as of the most recent practicable date. Disclose the date as of which the information is provided.
2. If a committee, team, or other group of persons that includes the Portfolio Manager is jointly and primarily responsible for the day-to-day management of the portfolio of an account, include the account in responding to Item 21.1.
2.
1. Provide the information required by Item 21.2 as of the end of the Registrant's most recently completed fiscal year, except that, in the case of an initial registration statement or an update to the Registrant's registration statement that discloses a new Portfolio Manager, information with respect to any newly identified Portfolio Manager must be provided as of the most recent practicable date. Disclose the date as of which the information is provided.
2. Compensation includes, without limitation, salary, bonus, deferred compensation, and pension and retirement plans and arrangements, whether the compensation is cash or non-cash. Group life, health, hospitalization, medical reimbursement, relocation, and pension and retirement plans and arrangements may be omitted, provided that they do not discriminate in scope, terms, or operation in favor of the Portfolio Manager or a group of employees that includes the Portfolio Manager and are available generally to all salaried employees. The value of compensation is not required to be disclosed under this Item.
3. Include a description of the structure of, and the method used to determine, any compensation received by the Portfolio Manager from the Registrant, the Registrant's investment adviser, or any other source with respect to management of the Registrant and any other accounts included in the response to Item 21.1.b. This description must clearly disclose any differences between the method used to determine the Portfolio Manager's compensation with respect to the Registrant and other accounts,
3.
1. Provide the information required by Item 21.3 as of the end of the Registrant's most recently completed fiscal year, except that, in the case of an initial registration statement or an update to the Registrant's registration statement that discloses a new Portfolio Manager, information with respect to any newly identified Portfolio Manager must be provided as of the most recent practicable date. Specify the valuation date.
2. Determine “beneficial ownership” in accordance with rule 16a-1(a)(2) under the Exchange Act (17 CFR 240.16a-1(a)(2)).
The additions and revisions are to read as follows:
The text of Form N-3 does not, and these amendments will not, appear in the Code of Federal Regulations.
(a) * * *
(vi) A statement or statements that (A) The prospectus sets forth information about the Registrant that a prospective investor ought to know before investing; (B) the prospectus should be retained for future reference; and (C) additional information about the Registrant has been filed with the Commission and is available upon written or oral request and without charge (This statement should explain how to obtain the Statement of Additional Information (“SAI”), whether any of it has been incorporated by reference into the prospectus, and where the table of contents of the SAI appears in the prospectus. This statement should also explain how to obtain the Registrant's annual and semi-annual reports to shareholders. Provide a toll-free (or collect) telephone number for investors to call: to request the SAI; to request the Registrant's annual report; to request the Registrant's semi-annual report; to request other information about the Registrant; and to make shareholder inquiries. Also state whether the Registrant makes available its SAI and annual and semi-annual reports, free of charge, on or through the Registrant's Web site at a specified Internet address. If the Registrant does not make its SAI and shareholder reports available in this manner, disclose the reasons why it does not do so (including, where applicable, that the Registrant does not have an Internet Web site.) Also include the information that the Commission maintains an Internet Web site (
(e) The name, title, and length of service of the person or persons employed by or associated with the Registrant or an investment adviser of the Registrant who are primarily responsible for the day-to-day management of the Registrant's portfolio (“Portfolio Manager”). Also state each Portfolio Manager's business experience during the past 5 years. Include a statement, adjacent to the foregoing disclosure, that the SAI provides additional information about the Portfolio Manager's(s’) compensation, other accounts managed by the Portfolio Manager(s), and the Portfolio Manager's(s’) ownership of securities in the Registrant.
1. This requirement does not apply to a Registrant that holds itself out as a money market fund and meets the maturity, quality, and diversification requirements of rule 2a-7 [17 CFR 270.2a-7].
2. If a committee, team, or other group of persons associated with the Registrant or an investment adviser of the Registrant is jointly and primarily responsible for the day-to-day management of the Registrant's portfolio, information in response to this Item is required for each member of such committee, team, or other group. For each such member, provide a brief description of the person's role on the committee, team, or other group (
(a) If a Portfolio Manager required to be identified in response to Item 6(e) is primarily responsible for the day-to-day management of the portfolio of any other account, provide the following information:
(i) The Portfolio Manager's name;
(ii) The number of other accounts managed within each of the following categories and the total assets in the accounts managed within each category:
(A) Registered investment companies;
(B) Other pooled investment vehicles; and
(C) Other accounts.
(iii) For each of the categories in paragraph (a)(ii) of this Item, the number of accounts and the total assets in the accounts with respect to which the advisory fee is based on the performance of the account; and
(iv) A description of any material conflicts of interest that may arise in connection with the Portfolio Manager's management of the Registrant's investments, on the one hand, and the investments of the other accounts included in response to paragraph (a)(ii) of this Item, on the other. This description would include, for example, material conflicts between the investment strategy of the Registrant and the investment strategy of other accounts managed by the Portfolio Manager and material conflicts in allocation of investment opportunities between the Registrant and other accounts managed by the Portfolio Manager.
1. Provide the information required by paragraph (a) of this Item as of the end of the Registrant's most recently completed fiscal year, except that, in the case of an initial registration statement or an update to the Registrant's registration statement that discloses a new Portfolio Manager, information with respect to any newly identified Portfolio Manager must be provided as of the most recent practicable date. Disclose the date as of which the information is provided.
2. If a committee, team, or other group of persons that includes the Portfolio Manager is jointly and primarily responsible for the day-to-day management of the portfolio of an account, include the account in responding to paragraph (a) of this Item.
(b) Describe the structure of, and the method used to determine, the compensation of each Portfolio Manager required to be identified in response to Item 6(e). For each type of compensation (
1. Provide the information required by paragraph (b) of this Item as of the end of the Registrant's most recently completed fiscal year, except that, in the case of an initial registration statement or an update to the Registrant's registration statement that discloses a new Portfolio Manager, information with respect to any newly identified Portfolio Manager must be provided as of the most recent practicable date. Disclose the date as of which the information is provided.
2. Compensation includes, without limitation, salary, bonus, deferred compensation, and pension and retirement plans and arrangements, whether the compensation is cash or non-cash. Group life, health, hospitalization, medical reimbursement, relocation, and pension and retirement plans and arrangements may be omitted, provided that they do not discriminate in scope, terms, or operation in favor of the Portfolio Manager or a group of employees that includes the Portfolio Manager and are available generally to all salaried employees. The value of compensation is not required to be disclosed under this Item.
3. Include a description of the structure of, and the method used to determine, any compensation received by the Portfolio Manager from the Registrant, the Registrant's investment adviser, or any other source with respect to management of the Registrant and any other accounts included in the response to paragraph (a)(ii) of this Item. This description must clearly disclose any differences between the method used to determine the Portfolio Manager's compensation with respect to the Registrant and other accounts,
(c) For each Portfolio Manager required to be identified in response to Item 6(e), state the dollar range of equity securities in the Registrant beneficially owned by the Portfolio Manager using the following ranges: none, $1-$10,000, $10,001-$50,000, $50,001-$100,000, $100,001-$500,000, $500,001-$1,000,000, or over $1,000,000.
1. Provide the information required by paragraph (c) of this Item as of the end of the Registrant's most recently completed fiscal year, except that, in the case of an initial registration statement or an update to the Registrant's registration statement that discloses a new Portfolio Manager, information with respect to any newly identified Portfolio Manager must be provided as of the most recent practicable date. Specify the valuation date.
2. Determine “beneficial ownership” in accordance with rule 16a-1(a)(2) under the Exchange Act (17 CFR 240.16a-1(a)(2)).
The additions and revisions are to read as follows:
The text of Form N-CSR does not, and these amendments will not, appear in the Code of Federal Regulations.
(a) If the registrant is a closed-end management investment company that is filing an annual report on this Form N-CSR, provide the following information:
(1) State the name, title, and length of service of the person or persons employed by or associated with the registrant or an investment adviser of the registrant who are primarily responsible for the day-to-day management of the registrant's portfolio (“Portfolio Manager”). Also state each Portfolio Manager's business experience during the past 5 years.
1. Provide the information required by this paragraph as of the date of filing of the report. Disclose the date as of which the information is provided.
2. If a committee, team, or other group of persons associated with the registrant or an investment adviser of the registrant is jointly and primarily responsible for the day-to-day management of the registrant's portfolio, information in response to this Item is required for each member of such committee, team, or other group. For each such member, provide a brief description of the person's role on the committee, team, or other group (
(2) If a Portfolio Manager required to be identified in response to paragraph (a)(1) of this Item is primarily responsible for the day-to-day management of the portfolio of any other account, provide the following information:
(i) The Portfolio Manager's name;
(ii) The number of other accounts managed within each of the following categories and the total assets in the accounts managed within each category:
(A) Registered investment companies;
(B) Other pooled investment vehicles; and
(C) Other accounts.
(iii) For each of the categories in paragraph (a)(2)(ii) of this Item, the number of accounts and the total assets in the accounts with respect to which the advisory fee is based on the performance of the account; and
(iv) A description of any material conflicts of interest that may arise in connection with the Portfolio Manager's management of the registrant's investments, on the one hand, and the investments of the other accounts included in response to paragraph (a)(2)(ii) of this Item, on the other. This description would include, for example, material conflicts between the investment strategy of the registrant and the investment strategy of other accounts managed by the Portfolio Manager and material conflicts in allocation of investment opportunities between the registrant and other accounts managed by the Portfolio Manager.
1. Provide the information required by this paragraph as of the end of the registrant's most recently completed fiscal year, except that, in the case of any newly identified Portfolio Manager,
2. If a committee, team, or other group of persons that includes the Portfolio Manager is jointly and primarily responsible for the day-to-day management of the portfolio of an account, include the account in responding to paragraph (a)(2) of this Item.
(3) Describe the structure of, and the method used to determine, the compensation of each Portfolio Manager required to be identified in response to paragraph (a)(1) of this Item. For each type of compensation (
1. Provide the information required by this paragraph as of the end of the registrant's most recently completed fiscal year, except that, in the case of any newly identified Portfolio Manager, information must be provided as of the most recent practicable date. Disclose the date as of which the information is provided.
2. Compensation includes, without limitation, salary, bonus, deferred compensation, and pension and retirement plans and arrangements, whether the compensation is cash or non-cash. Group life, health, hospitalization, medical reimbursement, relocation, and pension and retirement plans and arrangements may be omitted, provided that they do not discriminate in scope, terms, or operation in favor of the Portfolio Manager or a group of employees that includes the Portfolio Manager and are available generally to all salaried employees. The value of compensation is not required to be disclosed under this Item.
3. Include a description of the structure of, and the method used to determine, any compensation received by the Portfolio Manager from the registrant, the registrant's investment adviser, or any other source with respect to management of the registrant and any other accounts included in the response to paragraph (a)(2)(ii) of this Item. This description must clearly disclose any differences between the method used to determine the Portfolio Manager's compensation with respect to the registrant and other accounts,
(4) For each Portfolio Manager required to be identified in response to paragraph (a)(1) of this Item, state the dollar range of equity securities in the registrant beneficially owned by the Portfolio Manager using the following ranges: none, $1-$10,000, $10,001-$50,000, $50,001-$100,000, $100,001-$500,000, $500,001-$1,000,000, or over $1,000,000.
1. Provide the information required by this paragraph as of the end of the registrant's most recently completed fiscal year, except that, in the case of any newly identified Portfolio Manager, information must be provided as of the most recent practicable date. Specify the valuation date.
2. Determine “beneficial ownership” in accordance with rule 16a-1(a)(2) under the Exchange Act (17 CFR 240.16a-1(a)(2)).
(b) If the registrant is a closed-end management investment company that is filing a report on this Form N-CSR other than an annual report, disclose any change, as of the date of filing, in any of the Portfolio Managers identified in response to paragraph (a)(1) of this Item in the registrant's most recent annual report on Form N-CSR. In addition, for any newly identified Portfolio Manager, provide the information required by paragraph (a)(1) of this Item as of the date of filing of the report and the information required by paragraphs (a)(2), (a)(3), and (a)(4) of this Item as of the most recent practicable date.
By the Commission.