Notices. Temporary final rule; additional correction
27,564 words·~125 min read·
/register/2007/09/24/07-4681A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 5001-06-M DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket No. USCG-2007-29153] RIN 1625-AA87 Security Zone; Hawaii Superferry Arrival/Departure, Nawiliwili Harbor, Kauai, HI AGENCY: Coast Guard, DHS. ACTION: Temporary final rule; additional correction. SUMMARY: This document corrects a typographical error in a U.S. Code section number and corrects a reference to an access road on the jetty south of Nawiliwili Park in a temporary final rule entitled “Security Zone;
Hawaii Super Ferry Arrival/Departure, Nawiliwili Harbor, Kauai, Hawaii” that was published September 5, 2007, in the **Federal Register** . DATES: These corrections are effective September 24, 2007. FOR FURTHER INFORMATION CONTACT: Lieutenant (Junior Grade) Jasmin Parker, U.S. Coast Guard Sector Honolulu at 808-842-2673. SUPPLEMENTARY INFORMATION: On September 5, 2007, the Coast Guard published a temporary final rule entitled “Security Zone; Hawaii Super Ferry Arrival/Departure, Nawiliwili Harbor, Kauai, Hawaii” in the **Federal Register** (72 FR 50877).
In that document references were made to Waapa Road being included in the security zone covering land on the jetty south of Nawiliwili Park. The road in the zone is not named “Waapa Road”; instead, that jetty access road is commonly known as “Jetty Road.” Also, when citing to the authority for making the rule effective less than 30 days after publication, instead of citing to 5 U.S.C. 553(d)(3), because of a typographic error, that section was cited as “533.” This document corrects those errors.
A previous correction document for this rule was published September 13, 2007 (72 FR 52282). Correction Instructions In rule FR Doc. 07-4357 published on September 5, 2007 (72 FR 50877), make the following corrections: 1. On page 50877, in the first column, in line 17, remove the words “Waapa Road” and add, in their place, the words “the jetty access road (commonly known as Jetty Road)”. 2. On page 50877, in the second column, in line 21, remove “533” and add, in its place, “553”. § 165.T14-160 [Corrected] 3.
On page 50879, in the first line of the second column, in § 165.T14-160(a), remove the words “Waapa Road” and add, in their place, the words “the jetty access road (commonly known as Jetty Road)”. Dated: September 19, 2007. Stefan G. Venckus, Chief, Office of Regulations and Administrative Law, United States Coast Guard. [FR Doc. E7-18783 Filed 9-21-07; 8:45 am] BILLING CODE 4910-15-P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 54 [WC Docket No. 05-195, CC Docket No. 96-45, CC Docket No. 02-6, WC Docket No. 02-60, WC Docket No. 03-109, CC Docket No. 97-21;
FCC 07-150] Measures To Safeguard the Universal Service Fund From Waste, Fraud, and Abuse as Well as Measures To Improve the Management, Administration, and Oversight of the Universal Service Fund AGENCY: Federal Communications Commission. ACTION: Final rule. SUMMARY: In the Report and Order, the Commission adopted measures to safeguard the Universal Service Fund (“USF”) from waste, fraud, and abuse. The intended effect of the measures adopted is to improve the management, administration, and oversight of the USF.
DATES: Effective October 24, 2007 except for the amendments to §§ 54.202, 54.417, 54.619, and 54.706, which contain information collection requirements that are not effective until approved by the Office of Management and Budget. The FCC will publish a document in the **Federal Register** announcing the effective date for those sections. Additionally, the Commission will send, as a minor rule, a copy of this Report and Order to Congress and the Government Accountability Office pursuant to the Congressional Review Act, 5 U.S.C. 801(a)(1)(A).
FOR FURTHER INFORMATION CONTACT: Mika Savir at
(202)418-0384, *Mika.Savir@fcc.gov,* Office of Managing Director, Federal Communications Commission, 445 12th Street, SW., Washington, DC 20554. In addition, a copy of any comments on the Paperwork Reduction Act information collection requirements contained herein should be submitted to Leslie Smith, Federal Communications Commission, 445 12th Street, SW., Washington, DC 20554, or via the Internet to *PRA@fcc.gov.* SUPPLEMENTARY INFORMATION: This is a summary of the Commission's Report and Order adopted August 22, 2007 and released August 29, 2007. The full text of this Report and Order is available for public inspection on the Commission's Internet site at *http://www.fcc.gov.* It is also available for inspection and copying during regular business hours in the FCC Reference Center (Room CY-A257), 445 12th Street, SW., Washington, DC 20554. The full text of this document also may be purchased from the Commission's duplication contractor, Best Copy and Printing Inc., Portals II, 445 12th St., SW., Room CY-B402, Washington, DC 20554; telephone
(202)488-5300; fax
(202)488-5563; e-mail *FCC@BCPIWEB.COM.* The Universal Service Fund (“USF”) was created by Congress in 1996 as part of its passage of the Telecommunications Act of 1996. The purpose of the fund is to help provide affordable telecommunications services to consumers, libraries, rural health care facilities, and schools. Today, the USF consists of four programs:
(1)The universal service mechanism for high-cost areas, providing financial support to eligible telecommunications carriers serving high-cost areas;
(2)the universal service mechanism for schools and libraries, providing for discounted services (telecommunications services, Internet access, and internal connections) to eligible schools and libraries;
(3)the universal service mechanism for assisting low-income consumers with discounted installation and monthly telephone services; and
(4)the universal service mechanism for rural health care, providing discounted telecommunications and information services to rural health care providers. These funds are managed, on behalf of the Commission, by the Universal Service Administrative Company (“USAC” or “Administrator”). The goal of the proceeding, initiated on June 14, 2005, was to improve these four universal service programs, to make these programs more effective and efficient, and to continue the Commission's efforts to deter waste, fraud, and abuse of Universal Service funds. In conducting the proceeding, input was sought from all interested parties, including USF participants. Eighty-four comments were received and considered as the Commission came to its decisions on how to improve the management, administration, and oversight of the USF. Synopsis On June 14, 2005, the Commission initiated a broad inquiry into the management, administration, and oversight of the USF. That inquiry asked whether:
(a)The Commission should adopt rules requiring timely payments and assessing penalties or interest for late payments to the USF programs;
(b)the Commission should institute a targeted independent audit requirement to safeguard the USF programs from waste, fraud, and abuse;
(c)the Commission should put in place document retention requirements for applicants and service providers;
(d)the Commission should establish time limits for making determinations about whether violations have occurred among USF program recipients;
(e)the Commission should adopt specific sanctions to address instances in which a USF beneficiary may not have used funds in accordance with program procedures;
(f)the Commission should institute aggressive debarment procedures for anyone who defrauds or otherwise deliberately harms the integrity of the USF programs; and
(g)the Commission should require USAC to report on certain efficiency, effectiveness, accuracy, and timeliness performance measures.
(a)Decision regarding timely payments—since the USF is supported by contributions from telecommunications carriers providing interstate services as well as contributions by certain providers of interstate telecommunications, including providers of Interconnected Voice over Internet Protocol (“Interconnected VoIP”) services, the Commission determined that it should adopt tougher rules requiring timely payments and assessing penalties or interest for late payments. Thus, the Commission decided that it would replace the existing late-filing charge, as well as the late-payment charges; with a new “rate of interest” charge that reflects the consequences of failing to pay in a timely manner. Henceforth, if a contributor is more than 30 days delinquent in paying its contribution to the USF, USAC shall assess a single rate of interest, that will apply to the debt from the date of the delinquency until date of payment (or in the case of a promissory note the date of maturity of the note), at an annual rate equal to the U.S. prime rate on the date of delinquency plus 3.5 percent. Likewise, if a contributor is more than 30 days delinquent in filing an FCC Form 499-A or 499-Q, the USAC Administrator shall also use the U.S. prime rate plus 3.5 percent in assessing a remedial sanction. The sanction will be the greater of $100 per month or the amount derived when a rate of interest equal to the U.S. prime rate plus 3.5 percent is assessed on the amount due per the USAC Administrator's invoice or calculations (if no invoice was provided). In the event a contributor company is delinquent in filing an FCC Form 499-A or 499-Q, and within the 30 day period following delinquency, is also delinquent in paying its contribution, interest will be assessed on a single greater amount from the date of the first delinquency. USAC is now required to add information to the monthly invoice sent to contributors and in debt collection correspondence to explain the applicable sanction and administrative charges for late payment.
(b)Decision regarding independent audits—audits are a tool the Commission and USAC use to ensure program integrity and to detect violations of the Act or the Commission's rules and to deter waste, fraud, and abuse. Current Commission rules already authorize the USAC Administrator to conduct audits of contributors to the universal service support mechanisms. In addition, the Commission's OIG annually oversees more than 400 audits of contributors and beneficiaries of the high-cost, low-income, rural health care, and schools and libraries programs. The Commission has decided that additional audit requirements are unnecessary at this time. The Commission will closely watch the data emerging from existing audits to determine if additional or targeted audits should be conducted in the future.
(c)Decision regarding document retention—proper record-keeping helps prevent waste, fraud, and abuse. Proper record-keeping additionally protects applicants and service providers in the event of vendor disputes. The Commission concluded that, following OMB approval of these Paperwork Reduction Act information collection requirements, the following record-keeping will be required:
(1)High-cost program—the Commission will require recipients of universal service high-cost support to retain, for five years, all records that they may require to demonstrate to auditors that the support they received was consistent with the Communications Act of 1934, as amended, and the Commission's rules. These records must include the following: Data supporting line count filings; historical customer records; fixed asset property accounting records; general ledgers; invoice copies for the purchase and maintenance of equipment; maintenance contracts for the upgrade or equipment; and any other relevant documentation. The Commission also clarified that beneficiaries must make available all such documents and records that pertain to them, including those of NECA, contractors, and consultants working on behalf of the beneficiaries to the Commission's OIG, to the USAC Administrator, and to their auditors. To the extent other rules or any other law require or necessitate documents be kept for longer periods of time (e.g., to support the account balances in the Part 32 Uniform System of Accounts, continuing property records, pole attachment calculations, plant equipment age, cost, or useful life, depreciation rates), the Commission did not alter, amend, or supplant such rules or laws.
(2)Low-income program—with respect to the Lifeline and Link-Up programs, the Commission concluded that a “service-plus three” document retention requirement will be retained. The Commission did not believe it to be unnecessarily burdensome to require participating service providers to retain eligibility-determination records for the time period during which the service is provided and then for three years after the service is terminated. Additionally, the Commission removed the clause that waived the document retention requirement after an audit is completed. The Commission also clarified that beneficiaries must make available all documents and records that pertain to them, including those of contractors and consultants working on their behalf, to the Commission's OIG, to the USAC Administrator, and to auditors working on their behalf.
(3)Rural Health Care and Schools and Libraries programs—the Commission decided to retain the five year requirement for schools and libraries to retain records evidencing that the funding they received was proper. The Commission also decided to expand this requirement to rural health care service providers. This Report and Order additionally clarified that beneficiaries must make available all documents and records that pertain to them, including those of contractors and consultants working on their behalf, to the Commission's OIG, to the USAC Administrator, and to their auditors.
(4)Contributors—the Commission also required contributors to the USF to retain all documents and records necessary to demonstrate to auditors that their contributions were made in compliance with the program rules, assuming that the audits are conducted within five years of such contribution. The Commission clarified that contributors must make available all documents and records that pertain to them, including those of contractors and consultants working on their behalf, to the Commission's OIG, to the USAC Administrator, and to their auditors. These documents and records should include without limitation the following: financial statements and supporting documentation; accounting records; historical customer records; general ledgers; and any other relevant documentation.
(d)Decision regarding time limits for determining violations—the Commission will adopt a five-year administrative limitations period for all funds. During these five years the Commission or the USAC Administrator may determine that a violation has occurred among recipients of the funds. This five year limit, which currently applies only to recipients of the schools and libraries fund, will now apply to recipients of all USF programs. This time period appropriately balances the beneficiary's need for finality with the Commission statutory obligation to safeguard the USF programs from waste, fraud, and abuse. This five-year time period is not a statute of limitations.
(e)Decision regarding sanctions for misuse of funds—consistent with a prior Commission conclusion regarding the schools and libraries program, the Commission determined that funds disbursed from the high-cost, low-income, and rural health care support mechanisms that are disbursed or used in violation of a Commission rule that implements the statute or a substantive program goal should be recovered. The Commission has determined that sanctions, including enforcement action, are appropriate in cases of waste, fraud, and abuse, but not in cases of clerical or ministerial errors.
(f)Decision regarding debarment for actions that harm the integrity of the program—there have been several well-publicized cases of fraud against the schools and libraries program. In order to prevent further fraud, and to prevent bad actors from continuing to participate in this program, the Commission earlier adopted a three year debarment rule for the schools and libraries program that suspends and debar parties who are convicted of criminal violations or held civilly liable for acts arising out of participation in the schools and libraries program, absent extraordinary circumstances. The Commission now applies these debarment procedures to all Universal Service programs. Henceforth, any party convicted of or held civilly liable for the commission or attempted commission of fraud and similar offenses will be debarred from participation in the program for a period of three years. Additionally, the Commission and the USAC Administrator will publish the names of these debarred entities on their respective Internet websites. The USAC Administrator will also provide a link from its website to the Bureau and Commission debarment orders.
(g)Decision regarding performance measures—following the requirements of the Government Performance and Results Act, the Commission established the following performance measures:
(1)Schools and Libraries—since nearly 100 percent connectivity to the Internet already exists for public schools and the Commission is not in a position to evaluate either the impact of schools and libraries funds on connectivity as compared to other funding sources or the impact of Internet connectivity on educational outcomes, the Commission decided on group of policy, productivity, and efficiency performance measures. In the policy arena, the USAC Administrator is to collect information during interviews with schools and libraries about the different types or capacities of broadband services that are supported through the school and libraries program. The Commission further requires the USAC Administrator to work with the Wireline Competition Bureau (“Bureau”) to modify the relevant FCC forms or to create additional questions for program participants to more accurately determine how schools and libraries connect to the Internet and their precise levels of connectivity. The collections of such additional information, after approval by OMB under the terms of the Paperwork Reduction Act, will enable the Commission to identify the specific products, services, and capabilities (e.g., T-1s, DS-3s) at specific quantities provided by the schools and libraries program. The Commission also requires the USAC Administrators to cross-reference participating school districts with a full listing of school districts to identify the public schools that are not participating in the schools and libraries program in order to focus outreach on these schools. The USAC Administrator should determine why these schools and libraries choose not to participate and assist them, if necessary, in the beginning of the application process. The USAC Administrator should report its conclusions to the Commission annually. In the productivity arena, the Commission is requiring the USAC Administrator to provide data, on a funding year basis, reporting the number of applications and funding request numbers (“FRNs”) submitted, the number of applications and FRNs rejected, the number of applications and FRNs granted, and the processing time for applications and FRNs. The USAC Administrator is also required to document the amount of time it takes to make a payment to the service provider, from the date the proper form is submitted. The Commission recognizes that the USAC Administrator could reject more invoices in order to improve the amount of time it takes to make payments. For this reason, the Commission also requires the USAC Administrator to provide the number of paid invoices and the number of rejected invoices. In the efficiency arena, the Commission is directing the USAC Administrator to determine the percentage of appeals that are resolved by the USAC Administrator within 90 days from the date of appeal. The USAC Administrator will also provide information on how long it takes to process 50 percent, 75 percent, and 100 percent of the pending appeals from the schools and libraries division.
(2)Low-income—the Commission currently lacks the baseline information necessary to make an assessment of whether the program is accomplishing its goal. Therefore the Commission has directed the USAC Administrator to provide the following baseline information:
(a)Number of program beneficiaries (i.e., carriers);
(b)number of low-income customers for which each carrier receives low-income support;
(c)number of connections supported;
(d)time to process support payments and authorize disbursements;
(e)average
(mean)dollar amount awarded and median dollar amount awarded, per carrier; and
(f)total amount disbursed. This baseline information will assist the Commission in setting performance measures in the future. In addition, to further expand its baseline knowledge, the Commission requires the USAC Administrator to provide the Commission with specified information from a survey that is taken by service providers of the customers in the Lifeline benefits program. The information to be provided to the Commission includes:
(a)The number of Lifeline customers surveyed by the service providers;
(b)the Number of Lifeline customers found to be ineligible; and
(c)the Number of Lifeline customers who did not respond to the service provider survey. The Commission may revisit this issue at a later time and request further information from the Lifeline survey.
(3)Rural Health Care—the Commission requires the USAC Administrator to provide the following performance information: time to process applications; time to pay invoices; and time to determine appeals. These data will provide a baseline against which subsequent goals can be implemented in the future. Additionally, except for the rural health care pilot program, the USAC Administrator is to provide the Commission with specified productivity and efficiency performance data in regard to its application processing, invoice processing, and handling of appeals.
(4)High-cost—because it does not have sufficient data at this time to establish performance goals; the Commission directs the USAC Administrator to provide baseline information against which goals can be implemented in the future. The information to be provided includes the:
(a)Number of program beneficiaries per study area and per wire center;
(b)number of lines, per study area and per wire center
(c)number of requests for support payments;
(d)mean dollar amount of support and median dollar amount of support for each line;
(d)total amount disbursed;
(e)time to process 50 percent, 75 percent, and 100 percent of the high-cost support requests and authorize disbursements; and
(f)rates of telephone subscribership in urban versus rural areas.
(5)USAC Administrative Performance Measures—the Commission additionally adopted a requirement that the USAC Administrator provide some general, not program-specific, performance data. The required performance data include:
(a)The amount of payments determined to be improper payments and the error rate (i.e., the percentage of total payments that are determined to be improper payments);
(b)the amount of improper payments subsequently recovered from the beneficiaries by the USAC Administrator;
(c)data on USAC administrative costs, per program, and general administrative costs (not program-specific);
(d)the amount of payments determined to be improper payments and the error rate (i.e., the percentage of total payments that are determined to be improper payments), per program;
(e)the amount of improper payments subsequently recovered from the beneficiaries by the USF Administrator, per program;
(f)the number of corrections or true-ups due to errors by the USAC Administrator, per program;
(g)the number of USF contributors; number of USF contributors 90 days or more delinquent in payments;
(h)the total amount of delinquencies or past due payments;
(i)the total number of contributors assessed late fees or penalties;
(j)the total amount of late fees or penalties;
(k)the total amount of contributions to the USF; and
(l)the total amount of disbursements. List of Subjects in 47 CFR Part 54 Communications common carriers, Health facilities, Infants and children, Libraries, Reporting and recordkeeping requirements, Schools, Telecommunications, Telephone. Federal Communications Commission. Marlene H. Dortch, Secretary. Final Rules For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 54 as follows: 1. The authority citation for part 54 continues to read as follows: Authority: Secs. 5, 48 Stat. 1068, as amended; 47 U.S.C. 155. 2. Section 54.202 is amended by adding paragraph
(e)to read as follows: § 54.202 Additional requirements for Commission designation of eligible telecommunications carriers.
(e)All eligible telecommunications carriers shall retain all records required to demonstrate to auditors that the support received was consistent with the universal service high-cost program rules. These records should include the following: data supporting line count filings; historical customer records; fixed asset property accounting records; general ledgers; invoice copies for the purchase and maintenance of equipment; maintenance contracts for the upgrade or equipment; and any other relevant documentation. This documentation must be maintained for at least five years from the receipt of funding. 3. Section 54.417(a) is amended by revising the undesignated paragraph to read as follows: § 54.417 Recordkeeping requirements.
(a)* * * Notwithstanding the preceding sentence, eligible telecommunications carriers must maintain the documentation required in § § 54.409(d) and 54.410(b)(3) for as long as the consumer receives Lifeline service from that eligible telecommunications carrier 4. Redesignate § 54.521 as § 54.8 and revise pargraphs (a)(1), (a)(5), (a)(7), (c), (d), (e)(2)(i), (e)(3), (e)(4), and
(g)to read as follows: § 54.8 Prohibition on participation: Suspension and debarment.
(a)Definitions—(1) Activities associated with or related to the schools and libraries support mechanism, the high-cost support mechanism, the rural health care support mechanism, and the low-income support mechanism. Such matters include the receipt of funds or discounted services through one or more of these support mechanisms, or consulting with, assisting, or advising applicants or service providers regarding one or more of these support mechanisms.
(5)Debarment. Any action taken by the Commission in accordance with these regulations to exclude a person from activities associated with or relating to the schools and libraries support mechanism, the high-cost support mechanism, the rural health care support mechanism, and the low-income support mechanism. A person so excluded is “debarred.”
(7)Suspension. An action taken by the Commission in accordance with these regulations that immediately excludes a person from activities associated with or relating to the schools and libraries support mechanism, the high-cost support mechanism, the rural health care support mechanism, and the low-income support mechanism for a temporary period, pending completion of the debarment proceedings. A person so excluded is “suspended.”
(c)Causes for suspension and debarment. Causes for suspension and debarment are conviction of or civil judgment for attempt or commission of criminal fraud, theft, embezzlement, forgery, bribery, falsification or destruction of records, making false statements, receiving stolen property, making false claims, obstruction of justice and other fraud or criminal offense arising out of activities associated with or related to the schools and libraries support mechanism, the high-cost support mechanism, the rural health care support mechanism, and the low-income support mechanism.
(d)Effect of suspension and debarment. Unless otherwise ordered, any persons suspended or debarred shall be excluded from activities associated with or related to the schools and libraries support mechanism, the high-cost support mechanism, the rural health care support mechanism, and the low-income support mechanism. Suspension and debarment of a person other than an individual constitutes suspension and debarment of all divisions and/or other organizational elements from participation in the program for the suspension and debarment period, unless the notice of suspension and proposed debarment is limited by its terms to one or more specifically identified individuals, divisions, or other organizational elements or to specific types of transactions.
(e)* * *
(2)* * *
(i)Give the reasons for the proposed debarment in terms sufficient to put a person on notice of the conduct or transaction(s) upon which it is based and the cause relied upon, namely, the entry of a criminal conviction or civil judgment arising out of activities associated with or related to the schools and libraries support mechanism, the high-cost support mechanism, the rural health care support mechanism, and the low-income support mechanism;
(3)A person subject to proposed debarment, or who has an existing contract with a person subject to proposed debarment or intends to contract with such a person to provide or receive services in matters arising out of activities associated with or related to the schools and libraries support mechanism, the high-cost support mechanism, the rural health care support mechanism, and the low-income support mechanism may contest debarment or the scope of the proposed debarment. A person contesting debarment or the scope of proposed debarment must file arguments and any relevant documentation within thirty
(30)calendar days of receipt of notice or publication in the **Federal Register** , whichever is earlier.
(4)A person subject to proposed debarment, or who has an existing contract with a person subject to proposed debarment or intends to contract with such a person to provide or receive services in matters arising out of activities associated with or related to the schools and libraries support mechanism, the high-cost support mechanism, the rural health care support mechanism, and the low-income support mechanism may also contest suspension or the scope of suspension, but such action will not ordinarily be granted. A person contesting suspension or the scope of suspension must file arguments and any relevant documentation within thirty
(30)calendar days of receipt of notice or publication in the **Federal Register** , whichever is earlier.
(g)Time period for debarment. A debarred person shall be prohibited from involvement with the schools and libraries support mechanism, the high-cost support mechanism, the rural health care support mechanism, and the low-income support mechanism for three
(3)years from the date of debarment. The Commission may, if necessary to protect the public interest, set a longer period of debarment or extend the existing period of debarment. If multiple convictions or judgments have been rendered, the Commission shall determine based on the facts before it whether debarments shall run concurrently or consecutively. 5. Section 54.619 is amended by adding paragraph
(d)to read as follows: § 54.619 Audits and recordkeeping.
(d)Service providers. Service providers shall retain documents related to the delivery of discounted telecommunications and other supported services for at least 5 years after the last day of the delivery of discounted services. Any other document that demonstrates compliance with the statutory or regulatory requirements for the rural health care mechanism shall be retained as well. 6. Section 54.702 is amended by adding paragraph
(o)to read as follows: § 54.702 Administrator's functions and responsibilities.
(o)The Administrator shall provide performance measurements pertaining to the universal service support mechanisms as requested by the Commission by order or otherwise. 7. Section 54.706 is amended by adding paragraph
(e)to read as follows: § 54.706 Contributions.
(e)Any entity required to contribute to the federal universal service support mechanisms shall retain, for at least five years from the date of the contribution, all records that may be required to demonstrate to auditors that the contributions made were in compliance with the Commission's universal service rules. These records shall include without limitation the following: Financial statements and supporting documentation; accounting records; historical customer records; general ledgers; and any other relevant documentation. This document retention requirement also applies to any contractor or consultant working on behalf of the contributor. 8. Section 54.713 is revised to read as follows: § 54.713 Contributors' failure to report or to contribute.
(a)A contributor that fails to file a Telecommunications Reporting Worksheet and subsequently is billed by the Administrator shall pay the amount for which it is billed. The Administrator may bill a contributor a separate assessment for reasonable costs incurred because of that contributor's filing of an untruthful or inaccurate Telecommunications Reporting Worksheet, failure to file the Telecommunications Reporting Worksheet, or late payment of contributions. Failure to file the Telecommunications Reporting Worksheet or to submit required quarterly contributions may subject the contributor to the enforcement provisions of the Act and any other applicable law. The Administrator shall advise the Commission of any enforcement issues that arise and provide any suggested response. Once a contributor complies with the Telecommunications Reporting Worksheet filing requirements, the Administrator may refund any overpayments made by the contributor, less any fees, interest, or costs.
(b)If a universal service fund contributor fails to make full payment on or before the date due of the monthly amount established by the contributor's applicable Form 499-A or Form 499-Q, or the monthly invoice provided by the Administrator, the payment is delinquent. All such delinquent amounts shall incur from the date of delinquency, and until all charges and costs are paid in full, interest at the rate equal to the U.S. prime rate (in effect on the date of the delinquency) plus 3.5 percent, as well as administrative charges of collection and/or penalties and charges permitted by the applicable law (e.g., 31 U.S.C. 3717 and implementing regulations).
(c)If a universal service fund contributor is more than 30 days delinquent in filing a Telecommunications Reporting Worksheet Form 499-A or 499-Q, the Administrator shall assess an administrative remedial collection charge equal to the greater of $100 or an amount computed using the rate of the U.S. prime rate (in effect on the date the applicable Worksheet is due) plus 3.5 percent, of the amount due per the Administrator's calculations. In addition, the contributor is responsible for administrative charges of collection and/or penalties and charges permitted by the applicable law (e.g., 31 U.S.C. 3717 and implementing regulations). The Commission may also pursue enforcement action against delinquent contributors and late filers, and assess costs for collection activities in addition to those imposed by the Administrator.
(d)In the event a contributor fails both to file the Worksheet and to pay its contribution, interest will accrue on the greater of the amounts due, beginning with the earlier of the date of the failure to file or pay.
(e)If a universal service fund contributor pays the Administrator a sum that is less than the amount due for the contributor's universal service contribution, the Administrator shall adhere to the “American Rule” whereby payment is applied first to outstanding penalty and administrative cost charges, next to accrued interest, and third to outstanding principal. In applying the payment to outstanding principal, the Administrator shall apply such payment to the contributor's oldest past due amounts first. [FR Doc. E7-18711 Filed 9-21-07; 8:45 am] BILLING CODE 6712-01-P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 600 [Docket No. 070607179-7509-02] RIN 0648-AV66 Fishing Capacity Reduction Program for the Longline Catcher Processor Subsector of the Bering Sea and Aleutian Islands Non-pollock Groundfish Fishery, Industry Fee System AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Final rule. SUMMARY: NMFS establishes regulations to implement an industry fee system for repaying a $35 million Federal loan financing a fishing capacity reduction program in the longline catcher processor subsector of the Bering Sea and Aleutian Islands
(BSAI)non-pollock groundfish fishery. This action implements the fee collection system to ensure repayment of the loan. DATES: This final rule is effective, and fee payment collection begins, on October 24, 2007. ADDRESSES: Copies of the Environmental Assessment/Regulatory Impact Review/Final Regulatory Flexibility Analysis (EA/RIR/FRFA) prepared for the program and the FRFA for this final rule may be obtained from Leo Erwin, Chief, Financial Services Division, National Marine Fisheries Service, 1315 East-West Highway, Silver Spring, MD 20910-3282. Comments involving the burden-hour estimates or other aspects of the collection-of-information requirements contained in this final rule should be submitted in writing to Leo Erwin, at the above address, and to David Rostker, Office of Management and Budget (OMB), by email at *David_Rostker@omb.eop.gov* or by fax to 202-395-7285. FOR FURTHER INFORMATION CONTACT: Leo Erwin at 301-713 2390. SUPPLEMENTARY INFORMATION: I. Background Sections 312(b)-(e) of the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. 1861a(b) through (e)) generally authorized fishing capacity reduction programs. In particular, section 312(d) authorized industry fee systems for repaying the reduction loans which finance reduction program costs. Subpart L of 50 CFR part 600 (§§ 600.1000 through 600.1017) is the framework rule generally implementing sections 312(b)-(e). Subpart M of 50 CFR part 600 (§§ 600.1100 through 600.1105) contains specific fishery or program regulations. Sections 1111 and 1112 of the Merchant Marine Act, 1936 (46 U.S.C. 1279f and 1279g) generally authorized reduction loans. The FY 2005 Appropriations Act (Public Law 108-447, Section 219) authorized a fishing capacity reduction program for the longline catcher processor subsector of the BSAI non-pollock groundfish fishery (reduction fishery). NMFS published the longline catcher processor subsector BSAI non-pollock reduction program's (reduction program) proposed implementation rule on August 11, 2006 (71 FR 46364) and its final rule on September 29, 2006 (71 FR 57696). Anyone interested in the reduction program's full implementation details should refer to these two documents. NMFS proposed and adopted the reduction program's implementation rule as § 600.1105. The reduction program's objectives include promoting sustainable fishery management and maximum sustained reduction of fishing capacity from the reduction fishery at the least cost. This is a voluntary program in which, in return for reduction payments, selected offerors permanently relinquished their fishing licenses, surrendered the fishing histories upon which those licenses' issuance were based, and permanently withdrew vessels from fishing. NMFS financed the reduction program's $35 million cost, which post-reduction BSAI non-pollock groundfish longline catcher processors repay over an anticipated 30-year term but fees will continue indefinitely for as long as necessary to fully repay the loan. The fee amount, expressed in cents per pound rounded up to the next one-tenth of a cent, will be based upon the annual principal and interest due on the loan and could be up to 5 percent of longline catcher processor subsector BSAI Pacific cod landings. In the event that the total principal and interest due exceeds 5 percent of the ex-vessel Pacific cod revenues, an additional fee of one penny per pound will be assessed for pollock, arrowtooth flounder, Greenland turbot, skate, yellowfin sole and rock sole. The Freezer Longline Conservation Cooperative
(FLCC)received member offers and subsequently voted to accept four offers. The FLCC submitted a fishing capacity reduction plan (reduction plan) subsequently approved by NMFS. A referendum concerning the fees necessary for repayment of the $35 million loan followed the offer and acceptance process. Approval of the industry fee system required at least two-thirds of the votes cast in the referendum to be in favor before the reduction program could be implemented and payment tendered. NMFS mailed ballots to 39 qualified referendum voters on March 21, 2007, after approving the reduction plan. The voting period opened on March 21, 2007, and closed on April 6, 2007. NMFS received 34 timely and valid votes. All of the votes approved the fees. This exceeded the two-thirds minimum required for industry fee system approval. Consequently, this referendum was successful and approved the industry fee system. On April 26, 2007, NMFS published a **Federal Register** notice (72 FR 20836) advising the public that NMFS would, beginning on May 29, 2007, tender the reduction program's reduction payments to the four selected offerors. On May 29, 2007, NMFS required the selected offerors to permanently stop all fishing with the reduction vessels and permits. Subsequently, NMFS: 1. Disbursed $35,000,000 in reduction payments to the four selected offerors; 2. Revoked the relinquished reduction licenses; 3. Revoked each reduction vessel's fishing history; 4. Notified the National Vessel Documentation Center to revoke the reduction vessels' fishery trade endorsements and appropriately annotate the reduction vessel's document; and 5. Notified the U.S. Maritime Administration to prohibit the reduction vessel's transfer to foreign ownership or registry. Selected offerors participating in the reduction program have received $35 million in exchange for relinquishing valid non-interim Federal License Limitation Program BSAI groundfish licenses endorsed for catcher processor fishing activity, catcher/processor, Pacific cod, and hook and line gear, as well as any present or future claims of eligibility for any fishing privilege based on such permit, and additionally, any future fishing privilege of the vessel named on the permit. Individual fishing quota shares are excluded from relinquishment. On July 20, 2007, NMFS published proposed regulations in the **Federal Register** (72 FR 39779) to implement the program's industry fee system. II. Final Fee Regulations NMFS has completed the reduction program except for implementing the industry fee system. This final rule implements the industry fee system. The final rule will be effective, and fee payment and collection will begin on, October 24, 2007. The fee amount will be calculated on an annual basis as: the principal and interest payment amount due over the proceeding twelve months, divided by the reduction fishery portion of the BSAI Pacific cod initial total allowable catch
(ITAC)allocation in metric tons multiplied by 2,205 to convert into pounds, provided that the fees should not exceed 5 percent of the average ex-vessel production value of the reduction fishery. The terms defined in § 600.1105 of the reduction program's implementation rule and in § 600.1000 of the framework rule apply to this action. The framework rule's § 600.1013 governs fee payment and collection in general, and this action applies the § 600.1013 provisions to the reduction program. Under § 600.1013, the first ex-vessel buyers (fish buyers) of post-reduction fish (fee fish) subject to an industry fee system must withhold the fee from the trip proceeds which the fish buyers would otherwise have paid to the parties (fish sellers) who harvested and first sold the fee fish to the fish buyers. For the purpose of the fee collection, deposit, disbursement, and accounting requirements of this subpart, subsector members are deemed to be both the fish buyer and fish seller. In this case, all requirements and penalties of § 600.1013 that are applicable to both a fish seller and a fish buyer shall equally apply to parties performing both functions. The BSAI Pacific cod ITAC was chosen as the basis for fee calculation of the reduction program because Pacific cod is the only directed fishery with a total allowable catch set in advance of the fishing season. This methodology allows for a straightforward calculation of the fee due and simplifies future accounting. The fee will be assessed and collected on Pacific cod to the extent possible and if the amount is not sufficient to cover annual principal and interest due, additional fees will be assessed and collected. Fees will be assessed and collected on all harvested Pacific cod, including that used for bait or discarded. Although the fee could be up to 5 percent of the ex-vessel production value of all post-reduction longline catcher processor subsector non-pollock groundfish landings, the fee will be less than 5 percent if NMFS projects that a lesser rate can amortize the fishery's reduction loan over the reduction loan's 30-year term. If the total principal and interest due exceeds 5 percent of the ex-vessel Pacific cod revenues, a penny per pound round weight fee will be calculated based on the latest available revenue records and NMFS conversion factors for pollock, arrowtooth flounder, Greenland turbot, skate, yellowfin sole and rock sole. Any additional fees will be limited to the amount necessary to amortize the remaining twelve months principal and interest in addition to the 5 percent fee assessed against Pacific cod. If collections exceed the total principal and interest needed to amortize the payment due, the principal balance of the loan will be reduced. To verify that the fees collected do not exceed 5 percent of the reduction fishery revenues, the annual total of principal and interest due will be compared with the latest available annual reduction fishery revenues to ensure it is equal to or less than 5 percent of the total ex-vessel production revenues. In all likelihood this will be based on State of Alaska's Commercial Operator Annual Report produced annually in the March following the close of the previous season. If any of the components necessary to calculate the next year's fee are not available, or for any other reason NMFS believes the calculation must be postponed, the fee will remain at the previous year's amount until such time that new calculations are made and communicated to the post reduction fishery participants. The framework rule's § 600.1014 governs how fish buyers must deposit, and later disburse to NMFS, the fees which they have collected as well as how they must keep records of, and report about, collected fees. Under the framework rule's § 600.1014, fish buyers must, no less frequently than at the end of each business week, deposit collected fees through a date not more than two calendar days before the date of deposit in segregated and federally insured accounts. Fees shall be submitted to NMFS monthly and shall be due no later than fifteen
(15)calendar days following the end of each calendar month. Fee collection reports must accompany these disbursements. Fish buyers must maintain specified fee collection records for at least 3 years and submit to NMFS annual reports of fee collection and disbursement activities by February 1 of each calendar year. Under § 600.1015, the late charge to fish buyers for fee payment, collection, deposit, and/or disbursement shall be 1.5 percent per month. The full late charge shall apply to the fee for each month or portion of a month that the fee remains unpaid. To provide more accessible services, streamline collections, and save taxpayer dollars, fish buyers may disburse collected fee deposits to NMFS by using a secure Federal system on the Internet known as *Pay.gov* . *Pay.gov* enables subsector members to use their checking accounts to electronically disburse their collected fee deposits to NMFS. Subsector members who have access to the Internet should consider using this quick and easy collected fee disbursement method. Subsector members may access *Pay.gov* by going directly to *Pay.gov* 's Federal website at: *https://www.pay.gov/paygov/* . Subsector members who do not have access to the Internet or who simply do not wish to use the *Pay.gov* electronic system, must disburse collected fee deposits to NMFS by sending a check to our lockbox at: NOAA Fisheries Longline Catcher Processor Non-pollock Buyback P O Box 979028 St. Louis, MO 63197—9000 Subsector members must not forget to include with their disbursements the fee collection report applicable to each disbursement. Subsector members using *Pay.gov* will find an electronic fee collection report form to accompany electronic disbursements. Subsector members who do not use *Pay.gov* must include a hard copy fee collection report with each of their disbursements. Subsector members not using *Pay.gov* may also access the NMFS website for a PDF version of the fee collection report at: *http://www.nmfs.noaa.gov/mb/financial_services/buyback.htm* . NMFS will, before the fee's effective date, separately mail a copy of this rule, along with detailed fee payment, collection, deposit, disbursement, recording, and reporting information and guidance, to each fish seller and fish buyer of whom NMFS has notice. The fact that any fish seller or fish buyer might not, however, receive from NMFS a copy of the notice or of the information and guidance does not relieve the fish seller or fish buyer from his fee obligations under the applicable regulations. All parties interested in this action should carefully read the following framework rule sections, whose detailed provisions apply to the fee system for repaying the reduction program's loan: 1. § 600.1012; 2. § 600.1013; 3. § 600.1014; 4. § 600.1015; 5. § 600.1016; and 6. § 600.1017. NMFS, in accordance with the framework rule's § 600.1013(d), establishes the initial fee for the program's reduction fishery as 2.0 cents per pound. NMFS will then separately mail notification to each affected fish seller and fish buyer of whom NMFS has notice. Please see the framework rule's § 600.1000 for the definition of “delivery value” and of the other terms relevant to this proposed rule. Each disbursement of the reduction loan's $35,000,000 principal amount began accruing interest as of the date of each such disbursement. The loan's interest rate is the applicable rate, plus 2 percent, which the U.S. Treasury determines at the end of fiscal year 2007. III. Summary of Comments and Responses NMFS received one comment in response to the proposed fee regulations. The commenter wants to ban all longline fishing entirely, which is not in the scope of this action. This rule implements an industry fee system to repay the reduction program's $35 million loan. IV. Classification The Assistant Administrator for Fisheries, NMFS, determined that this final rule is consistent with the Magnuson-Stevens Fishery Conservation and Management Act, Consolidated Appropriations Act of 2005, and other applicable laws. In compliance with the National Environmental Policy Act, NMFS prepared an EA for the reduction program's final implementing rule (September 29, 2006; 71 FR 57696). The EA discusses the impact of this final rule on the natural and human environment and integrates an RIR and a FRFA. The EA resulted in a finding of no significant impact. The EA considered, among other alternatives, the implementation of the fee payment and collection in this action. NMFS will send the EA, RIR, and FRFA to anyone who requests a copy (see ADDRESSES ). NMFS prepared a Final Regulatory Flexibility Analysis (FRFA), as required by section 603 of the Regulatory Flexibility Act (RFA), to describe the economic impacts this rule would have on small entities. This final rule does not duplicate or conflict with other Federal regulations. FRFA Analysis The Small Business Administration has defined small entities as all fish harvesting businesses that are independently owned and operated, not dominant in its field of operation, and with annual receipts of $4 million or less. In addition, processors with 500 or fewer employees for related industries involved in canned or cured fish and seafood, or preparing fresh fish and seafood, are also considered small entities. Small entities within the scope of this final rule include individual U.S. vessels and dealers. There are no disproportionate impacts between large and small entities. Description of the Number of Small Entities The FRFA uses the most recent year of data available to conduct the analysis (2003). Most firms operating in the reduction fishery have annual gross revenues of less than $4 million. The FRFA analysis estimates that 24 of the remaining 36 active longline catcher processor vessels (i.e., 36 vessels constitute the post-reduction longline subsector) that participated in 2003 are considered small entities. The remaining 10 vessels are not considered small entities for purposes of the RFA. There is one additional fisherman with a permit but no vessel remaining in the longline subsector. The vessels that might be considered large entities were either affiliated under owners of multiple vessels or were catcher processors. However, little is known about the ownership structure of the vessels in the fleet, so it is possible that the FRFA overestimates the number of small entities. Because the final reduction program rule has not resulted in changes to allocation percentages and participation is voluntary, net effects are expected to be minimal relative to the status quo. The economic impact to communities where non-pollock groundfish are landed and processed would be minimal because the harvest quotas and allocations would not be altered. Fewer vessels in the catcher processor fleet may mean that fewer on-shore fleet support services would be required in Seattle and in Dutch Harbor. The communities would see little change because total landings of non-pollock groundfish would remain at current levels. Some beneficial impacts may occur because this program has provided $35 million to successful offerors. Much of this could be reinvested in the various communities which serve as home ports to the vessels and a portion would be recovered through income taxes. Crew employment opportunities will be reduced when vessels were removed from the fishery. However, those vessels remaining in the fishery will likely experience increased fishing opportunities and higher per capita incomes. The final rule's impact will be positive for both those whose offers NMFS has accepted, the selected offerors who received payments to stop fishing, and for post-reduction catcher processors whose landing fees repay the reduction loan. The owners whose offers NMFS accepted have relinquished their fishing licenses, reduction privilege vessels where appropriate, and fishing histories in exchange for payment. These payments ranged from $1.5 million for an inactive license that was not attached to a vessel, up to $11.8 million for the removal of both an active license and vessel from the fishery. Those owners remaining in the fishery after the reduction program will incur additional fees of up to 5 percent of the ex-vessel production value of post-reduction landings. However, the additional costs could be mitigated by increased harvest opportunities by post-reduction fishermen. This is because removal of the vessels from the fishery creates immediate benefits to the longline catcher processor subsector by reducing competition pressure for each of the remaining vessels to catch fish. In theory, each of the vessels retaining their fishing licenses will be able to harvest more fish. This will likely result in net benefits to the subsector members who have voluntarily assumed the additional fees necessary to repay the reduction loan. For example, even though each vessel could, on average, pay approximately $77,440 in fees, the net increase per vessel, on average, could be approximately $302,560 more than they would have been able to make before the reduction program's implementation due to the increased opportunity to harvest the TAC. This rule affects neither authorized BSAI Pacific cod ITAC and other non-pollock groundfish harvest levels or harvesting practices. NMFS rejected the no action alternative considered in the EA for the final rule implementing the reduction program because NMFS would not be in compliance with the mandate of Section 219 of the Act to establish a reduction program. In addition, the longline catcher processor subsector of the non-pollock groundfish fishery would remain overcapitalized. Although too many vessels compete to catch the current subsector ITAC allocation, fishermen remain in the fishery because they have no other means to recover their significant capital investment. Overcapitalization reduces the potential net value that could be derived from the non-pollock groundfish resource, by dissipating rents, driving variable operating costs up, and imposing economic externalities. At the same time, excess capacity and effort diminish the effectiveness of current management measures (e.g., landing limits and seasons, bycatch reduction measures). Overcapitalization has diminished the economic viability of members of the fleet and increased the economic and social burden on fishery dependent communities. It has been determined that this final rule is not significant for purposes of Executive Order 12866. This final rule contains collection-of-information requirements subject to the Paperwork Reduction Act. OMB has approved these information collections under OMB Control Number 0648-AU42. NMFS estimates that the public reporting burden for these requirements will average two hours for submitting a monthly fee collection report and four hours for submitting an annual fish buyer report. These response estimates include the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the information collection. Send comments regarding this burden estimate, or any other aspect of this data collection, including suggestions for reducing the burden, to both NMFS and OMB (see ADDRESSES ). Notwithstanding any other provision of the law, no person is required to respond to, and no person is subject to a penalty for failure to comply with, any information collection subject to the Paperwork Reduction Act unless that information collection displays a currently valid OMB control number. List of Subjects in 50 CFR Part 600 Fisheries, Fishing capacity reduction, Fishing permits, Fishing vessels, Intergovernmental relations, Loan programs business, Reporting and recordkeeping requirements. Dated: September 19, 2007. Samuel D. Rauch III Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service. For the reasons stated in the preamble, the National Marine Fisheries Service amends 50 CFR part 600 as follows: PART 600—MAGNUSON-STEVENS ACT PROVISIONS 1. The authority citation for part 600 continues to read as follows: Authority: 5 U.S.C. 561 and 16 U.S.C. 1801 *et seq.* 2. Section 600.1106 is added to subpart M to read as follows: § 600.1106 Longline catcher processor subsector Bering Sea and Aleutian Islands
(BSAI)non-pollock groundfish species fee payment and collection system.
(a)*Purpose.* As authorized by Public Law 108 447, this section's purpose is to:
(1)In accordance with § 600.1012, establish:
(i)The borrower's obligation to repay a reduction loan, and
(ii)The loan's principal amount, interest rate, and repayment term; and
(2)In accordance with §§ 600.1013 through 600.1016, implement an industry fee system for the reduction fishery.
(b)*Definitions.* Unless otherwise defined in this section, the terms defined in § 600.1000 and § 600.1105 expressly apply to this section. In addition, the following definition applies to this section: *Reduction fishery* means the longline catcher processor subsector of the BSAI non-pollock groundfish fishery that § 679.2 of this chapter defined as groundfish area/species endorsements.
(c)*Reduction loan amount.* The reduction loan's original principal amount is $35,000,000.
(d)*Interest accrual from inception.* Interest began accruing on the reduction loan from May 29, 2007, the date on which NMFS disbursed such loan.
(e)*Interest rate.* The reduction loan's interest rate shall be the applicable rate which the U.S. Treasury determines at the end of fiscal year 2007 plus 2 percent.
(f)*Repayment term.* For the purpose of determining fee rates, the reduction loan's repayment term is 30 years from May 29, 2007, but fees shall continue indefinitely for as long as necessary to fully repay the loan.
(g)*Reduction loan repayment.*
(1)The borrower shall, in accordance with § 600.1012, repay the reduction loan;
(2)For the purpose of the fee collection, deposit, disbursement, and accounting requirements of this subpart, subsector members are deemed to be both the fish buyer and fish seller. In this case, all requirements and penalties of § 600.1013 that are applicable to both a fish seller and a fish buyer shall equally apply to parties performing both functions;
(3)Subsector members in the reduction fishery shall pay and collect the fee amount in accordance with § 600.1105;
(4)Subsector members in the reduction fishery shall, in accordance with § 600.1014, deposit and disburse, as well as keep records for and submit reports about, the fees applicable to such fishery; except the requirements specified under paragraph
(c)of this section concerning the deposit principal disbursement shall be made to NMFS no later than fifteen
(15)calendar days following the end of each calendar month; and the requirements specified under paragraph
(e)of this section concerning annual reports which shall be submitted to NMFS by February 1 of each calendar year; and
(5)The reduction loan is, in all other respects, subject to the provisions of §§ 600.1012 through 600.1017. [FR Doc. E7-18788 Filed 9-21-07; 8:45 am] BILLING CODE 3510-22-S DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 622 [Docket No. 0612243157-7522-05; I.D. 112006B] RIN 0648-AT87 Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Reef Fish Fishery of the Gulf of Mexico; Extension of Effective Date of Gulf Red Snapper Management Measures AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Temporary rule; interim measures. SUMMARY: NMFS issues this temporary rule to amend, and extend the effective date of, interim measures to reduce overfishing of red snapper in Federal waters of the Gulf of Mexico implemented by a temporary rule published by NMFS on April 2, 2007. This temporary rule amends the regulations to provide an option for a special procedure for the initial calculation of Gulf of Mexico red snapper 2008 individual fishing quota allocations. The intended effect is to reduce overfishing of red snapper in the Gulf of Mexico. DATES: This rule is effective September 30, 2007, through March 28, 2008. ADDRESSES: Copies of the final environmental impact statement
(FEIS)and Record of Decision
(ROD)prepared for the April 2, 2007 interim final rule (72 FR 15617) are available from Peter Hood, Southeast Regional Office, NMFS, 263 13th Avenue South, St. Petersburg, FL 33701. FOR FURTHER INFORMATION CONTACT: Peter Hood, telephone: 727-551-5784, fax: 727-824-5308, e-mail: *peter.hood@noaa.gov* . SUPPLEMENTARY INFORMATION: The red snapper fishery of the Gulf of Mexico is managed under the Fishery Management Plan
(FMP)for the Reef Fish Resources of the Gulf of Mexico, and the shrimp fishery is managed under the FMP for the Shrimp Fishery of the Gulf of Mexico. The FMPs were prepared by the Gulf of Mexico Fishery Management Council (Council) and are implemented under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622. NMFS issued an interim rule (72 FR 15617, April 2, 2007) under section 305
(c)of the Magnuson-Stevens Act, to reduce fishing mortality on red snapper by reducing harvest and bycatch levels. Specifically, the rule:
(1)reduces red snapper total allowable catch
(TAC)from 9.12 million lb (4.14 million kg) to 6.5 million lb (2.9 million kg), whole weight, resulting in a commercial quota of 3.315 million lb (1.504 million kg) and a recreational quota of 3.185 million lb (1.445 million kg);
(2)reduces the commercial minimum size limit for red snapper from 15 inches (38 cm) to 13 inches (33 cm) total length (TL);
(3)reduces the daily recreational bag limit from four fish to two fish per person and prohibits the captain and crew of for-hire vessels (charter vessels and headboats) from retaining the recreational bag limit; and
(4)establishes a goal to reduce red snapper bycatch mortality in the shrimp fishery to 50 percent of the bycatch mortality that occurred during 2001-2003. These measures remain necessary to address overfishing of the red snapper resource. Under section 305 (c)(3)(B) of the Magnuson-Stevens Act, NMFS may extend the effectiveness of an interim rule for one additional period of not more than 186 days, provided the public has had an opportunity to comment on the interim rule and the Council is actively preparing proposed regulations to address the overfishing on a permanent basis. NMFS solicited public comments on the interim proposed rule (71 FR 75220, December 14, 2006) and received numerous comments. These comments were summarized and NMFS's responses were provided in the interim final rule (72 FR 15617, April 2, 2007). The Council has prepared joint Amendment 27/14 to the reef fish and shrimp fishery management plans in the Gulf of Mexico (Amendment 27/14). This amendment includes additional measures to end overfishing and to rebuild the red snapper stock. The expiration date of the interim rule is being extended so that NMFS may continue to address overfishing of red snapper while considering the implementation of more permanent measures recommended by the Council in Amendment 27/14. Failure to extend the effectiveness of the initial interim rule would result in overfishing of Gulf red snapper and would jeopardize the red snapper rebuilding plan. Additional details concerning the basis for these changes to the red snapper management measures and discussion of the ongoing efforts of the Council and NMFS to evaluate and implement measures to rebuild the red snapper stock consistent with the requirements of the Magnuson-Stevens Act are contained in the preamble of the interim proposed rule (71 FR 75220, December 14, 2006) and are not repeated here. Public comment and NMFS' responses are contained in the preamble of the interim final rule (72 FR 15617, April 2, 2007) and are not repeated here. In addition, this temporary rule amends the regulations to provide an option for a special procedure for the initial calculation of Gulf of Mexico red snapper 2008 individual fishing quota allocations. The Council has submitted Amendment 27/14 to NMFS for approval. If approved, Amendment 27/14 would, in addition to other measures, reduce the commercial red snapper quota from 3.315 million lb (1.504 million kg) to 2.55 million lb (1.16 million kg) beginning January 1, 2008. NMFS must calculate and issue 2008 individual fishing quota
(IFQ)allocations prior to January 1, 2008, the beginning of the commercial red snapper fishing season. If Amendment 27/14 is approved, and NMFS implements the reduced quota via appropriate rulemaking, there is a possibility that any reduced quota would not be implemented in time for NMFS to calculate the 2008 IFQ allocations. In that case, NMFS would have to issue allocation based on the higher quota currently in effect and then revoke some of that allocation later if the lower quota is implemented. This would be extremely disruptive to the industry and would likely result in overfishing, contrary to the rebuilding plan and a recent court order. To avoid this possible scenario, if Amendment 27/14 is approved but any final rule has not been implemented in time for NMFS to calculate and issue 2008 IFQ allocations, NMFS would initially calculate the 2008 IFQ allocations based on the Council's proposed commercial quota of 2.55 million lb (1.16 million kg) and, if necessary, make adjustments to allocations consistent with the actual 2008 quota when it is implemented. Classification The Administrator, Southeast Region, NMFS, (RA), has determined that this temporary rule is necessary to reduce overfishing of red snapper in the Gulf of Mexico, until more permanent measures are implemented, and is consistent with the Magnuson-Stevens Act and other applicable laws. The Council has prepared Amendment 27/14 to address red snapper overfishing issues on a permanent basis. This temporary rule has been determined to be significant for purposes of Executive Order 12866. This interim rule is exempt from the procedures of the Regulatory Flexibility Act because the rule is issued without opportunity for prior notice and comment. An FEIS was prepared for the interim measures contained in the April 2, 2007 interim rule. Because the conditions that existed at the time the April 2, 2007, interim rule was implemented have not changed, the impacts of continuing the interim measures through this extension have already been considered. Copies of the FEIS are available from NMFS (see ADDRESSES ). The Assistant Administrator for Fisheries, NOAA
(AA)finds good cause under U.S.C. 553 (b)(B) to waive prior notice and opportunity for public comment on this interim rule extension. This rule would continue interim measures implemented by the April 2, 2007 interim rule, for no more than an additional 186 days beyond the current expiration date of September 29, 2007. If the measures are not extended before the current rule lapses on that date, overfishing is certain to occur, contrary to the Magnuson-Stevens Act, the rebuilding plan for red snapper, and a recent court order. The conditions prompting the initial interim rule still remain, and NMFS is still considering more permanent measures recommended in Amendment 27/14. Opportunity for public comment was solicited on the interim proposed rule (71 FR 75220, December 14, 2006) and NMFS responded to those comments in the interim final rule (72 FR 15617, April 2, 2007). Failure to extend these measures would result in additional overfishing of Gulf red snapper and would jeopardize the success of the proposed new stock rebuilding plan. The amendment providing an option for a special procedure for the initial calculation of Gulf of Mexico red snapper 2008 individual fishing quota allocations is also necessary to avoid overfishing and potential confusion and disruption among red snapper IFQ participants that would otherwise result from initial issuance of 2008 IFQ allocation based on a higher quota that may be reduced just prior to or during the beginning of the 2008 fishing season. If this occurred NMFS would have to initially issue higher allocations and subsequently revoke them when the lower quota is implemented. This would confuse IFQ participants and disrupt transactions (transfers) of IFQ shares and allocation among participants and would likely result in overfishing. Therefore the AA finds that it would be impractical and contrary to the public interest to delay the implementation of these measures by providing additional opportunities for public comment. The AA also finds good cause under U.S.C. 553 (d)(3) to waive the delay of the effective date of this interim rule. A 30-day delayed effectiveness period of the extension of current measures would allow overfishing to continue on the red snapper stock and seriously increase the likelihood of frustrating the success of the new rebuilding plan prepared in compliance with a recent Court order. That order requires establishment of a new rebuilding plan, with a minimum probability of success of 50 percent, by December 12, 2007. Similarly, commercial red snapper fishermen need to know the amount of their minimum annual allocation well in advance to adequately plan their fishing business operations; avoid the loss of share and allocation trading opportunities; and avoid structuring future IFQ contracts based on a quota level that may not be available upon implementation of Amendment 27/14. Therefore, a delay in the effective date of the 2008 IFQ allocation procedures would be seriously and unnecessarily disruptive to the affected fishers. Therefore, NMFS finds good cause to waive the 30-day delay in effectiveness for both the extension of current measures and for the 2008 IFQ allocation procedures. List of Subjects in 50 CFR Part 622 Fisheries, Fishing, Puerto Rico, Reporting and recordkeeping requirements, Virgin Islands. Dated: September 18, 2007. Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service. For the reasons set out in the preamble, 50 CFR part 622 is amended as follows: PART 622—FISHERIES OF THE CARIBBEAN, GULF, AND SOUTH ATLANTIC 1. The authority citation for part 622 continues to read as follows: Authority: 16 U.S.C. 1801 *et seq.* 2. In § 622.16, paragraph (c)(9) is added to read as follows: § 622.16 Gulf red snapper individual fishing quota
(IFQ)program.
(c)* * *
(9)*Special procedure for initial calculation of 2008 IFQ allocations* . The Gulf of Mexico Fishery Management Council has submitted an amendment to NMFS, that if approved, would reduce the commercial red snapper quota from 3.315 million lb (1.504 million kg) to 2.55 million lb (1.16 million kg) beginning January 1, 2008. NMFS must calculate and issue 2008 IFQ allocations prior to January 1, 2008. If the amendment is approved but the final rule has not been implemented in time for NMFS to calculate and issue 2008 IFQ allocations, NMFS would initially calculate the 2008 IFQ allocations based on the Council's proposed commercial quota of 2.55 million lb (1.16 million kg) and, if necessary, NMFS would make adjustments to allocations consistent with the actual 2008 quota when it is implemented. [FR Doc. E7-18785 Filed 9-21-07; 8:45 am] BILLING CODE 3510-22-S 72 184 Monday, September 24, 2007 Proposed Rules DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 610 [Docket No. 2007N-0264] Revisions to the Requirements Applicable to Blood, Blood Components, and Source Plasma; Companion Document to Direct Final Rule; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule; correction. SUMMARY: The Food and Drug Administration is correcting a proposed rule that appeared in the **Federal Register** of August 16, 2007 (72 FR 45993). That document proposed to amend the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components, and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements. The proposal published as a companion document to the direct final rule that published in the same issue of the **Federal Register** (August 16, 2007, 72 FR 45883). Both documents published with a typographical error in the codified section. This document corrects the error in the proposed rule. Elsewhere in this issue of the **Federal Register** we are correcting the error in the direct final rule. DATES: Submit written or electronic comments on the proposed rule by October 30, 2007. ADDRESSES: You may submit comments on the proposed rule, identified by Docket No. 2007N-0264, by any of the following methods: *Electronic Submissions* Submit electronic comments in the following ways: • Federal eRulemaking Portal: *http://www.regulations.gov* . Follow the instructions for submitting comments. • Agency Web site: *http://www.fda.gov/dockets/ecomments* . Follow the instructions for submitting comments on the agency Web site. *Written Submissions* Submit written submissions in the following ways: • FAX: 301-827-6870. • Mail/Hand delivery/Courier (for paper, disk, or CD-ROM submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. To ensure more timely processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail. FDA encourages you to continue to submit electronic comments by using the Federal eRulemaking Portal or the agency Web site, as described previously, in the ADDRESSES portion of this document under *Electronic Submissions* . *Instructions* : All submissions received must include the agency name and docket number for this rulemaking. All comments received may be posted without change to *http://www.fda.gov/ohrms/dockets/default.htm* , including any personal information provided. For additional information on submitting comments, see the “Request for Comments” heading of the SUPPLEMENTARY INFORMATION section of the proposed rule (72 FR 45993 at 45995). *Docket* : For access to the docket to read background documents or comments received, go to *http://www.fda.gov/ohrms/dockets/default.htm* and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: *For information regarding this correction* : Joyce Strong, Office of Policy (HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7010. *For information regarding the proposed rule* : Stephen M. Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-6210. SUPPLEMENTARY INFORMATION: In FR Doc. E7-15942, appearing on page 45993, in the **Federal Register** of Thursday, August 16, 2007, the following correction is made: § 610.53 [Corrected] 1. On page 45996, in the amendment to § 610.53 *Dating periods for licensed biological products* , in the table in paragraph (c), “65° C” is corrected to read “−65° C” everywhere it appears. Dated: September 17, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-18802 Filed 9-21-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA-308P] Technical Amendment to Listing in Schedule III of Approved Drug Products Containing Tetrahydrocannabinols AGENCY: Drug Enforcement Administration (DEA), Department of Justice. ACTION: Notice of Proposed Rulemaking. SUMMARY: Under the current schedules of controlled substances in the DEA regulations, among the substances listed in schedule III is a synthetic isomer of tetrahydrocannabinols
(THC)contained in a specific formulation of a drug product approved by the U.S. Food and Drug Administration (FDA). As currently written, the DEA regulation would not necessarily include drug products approved by the FDA under section 505(j) of the Food, Drug, and Cosmetic Act
(FDCA)(21 U.S.C. 355) (commonly referred to as generic drugs) that cite the drug product currently listed in schedule III as the reference listed drug. DEA is hereby proposing to modify the regulation so that certain generic drug products are also included in the schedule III listing. DATES: Written comments must be postmarked, and electronic comments must be sent, on or before November 23, 2007. ADDRESSES: Please submit comments, identified by “Docket No. DEA-308,” by one of the following methods: 1. *Regular mail:* Deputy Administrator, Drug Enforcement Administration, Washington, DC 20537, Attention: DEA Federal Register Representative/ODL. 2. *Express mail:* DEA Headquarters, Attention: DEA Federal Register Representative/ODL, 2401 Jefferson-Davis Highway, Alexandria, VA 22301. 3. *E-mail comments directly to agency:* *dea.diversion.policy@usdoj.gov.* 4. *Federal eRulemaking portal:* *http://www.regulations.gov.* Follow the on-line instructions for submitting comments. *Posting of Public Comments:* Please note that all comments received are considered part of the public record and made available for public inspection online at *http://www.regulations.gov* and in the Drug Enforcement Administration's public docket. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all the personal identifying information you do not want posted online or made available in the public docket in the first paragraph of your comment and identify what information you want redacted. If you want to submit confidential business information as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be posted online or made available in the public docket. Personal identifying information and confidential business information identified and located as set forth above will be redacted and the comment, in redacted form, will be posted online and placed in the Drug Enforcement Administration's public docket file. If you wish to inspect the agency's public docket file in person by appointment, please see the “ FOR FURTHER INFORMATION ” paragraph. FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, Ph.D., Chief, Drug and Chemical Evaluation Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537; Telephone:
(202)307-7183. SUPPLEMENTARY INFORMATION: I. Summary Under the Controlled Substances Act (CSA), the schedules of controlled substances are published on an updated basis in the DEA regulations. 1 Currently, one of the substances listed in schedule III is the following: “Dronabinol (synthetic) in sesame oil and encapsulated in a soft gelatin capsule in a U.S. Food and Drug Administration approved product.” 2 This describes the drug product marketed under the brand name Marinol. As explained below, it is possible that generic versions of Marinol could be approved by the FDA yet not fit within the same schedule III listing as Marinol. The rule being proposed here would correct this situation so that certain generic versions of Marinol that might be approved by the FDA in the future will be in the same schedule as Marinol. 1 21 U.S.C. 812(a),
(c)and n. 1. 2 21 CFR 1308.13(g)(1). II. Detailed Explanation Background Dronabinol is a name of a particular isomer of a class of chemicals known as tetrahydrocannabinols (THC). Specifically, dronabinol is the United States Adopted Name
(USAN)for the (-)-isomer of Δ 9 -(trans)-tetrahydrocannabinol [(-)-Δ 9 -(trans)-THC], which is believed to be the major psychoactive component of the cannabis plant (marijuana). At present, Marinol is the only drug product containing any form of THC that has been approved for marketing by the FDA. 3 Accordingly, THC, as a general category, is listed in schedule I of the CSA, 4 while dronabinol contained in the Marinol formulation is listed separately in schedule III. Any other formulation containing dronabinol (or any other isomer of THC) remains a schedule I controlled substance. 5 3 The FDA approved Marinol in 1985 for the treatment of nausea and vomiting associated with cancer chemotherapy. In 1992, the FDA expanded Marinol's approved indications to include the treatment of anorexia associated with weight loss in patients with AIDS. 4 21 U.S.C. 812(c), Schedule I(c)(17). Schedule I contains those controlled substances with “no currently accepted medical use in treatment in the United States” and “a lack of accepted safety for use * * * under medical supervision.” 21 U.S.C. 812(b)(1). 5 The introductory language to schedule I(c) states that any material, compound, mixture, or preparation that contains any of the substances listed in schedule I(c) (including “tetrahydrocannabinols”) is a schedule I controlled substance “[u]nless specifically excepted or unless listed in another schedule.” The only material, compound, mixture, or preparation that contains THC but is listed in another schedule is the Marinol formulation, which is listed in schedule III. The current wording of the Marinol formulation in schedule III (21 CFR 1308.13(g)(1)) was added to the DEA regulations in 1986, when the substance was transferred from schedule I to schedule II after the FDA approved Marinol for marketing. 6 The wording of this listing was not specific to Marinol and thereby could include any generic product meeting that description that might be approved by the FDA in the future. However, at the time the regulation was promulgated, DEA did not anticipate the possibility that a generic formulation could be developed that did not fit precisely the wording of the listing that currently appears in schedule III. 6 51 FR 17476 (May 13, 1986). DEA subsequently transferred the FDA-approved Marinol formulation from schedule II to schedule III. 64 FR 35928 (July 2, 1999). Recently, firms have submitted to FDA abbreviated new drug applications
(ANDA)for their proposed generic versions of Marinol. As these ANDAs remain pending with the FDA, the precise nature of these formulations is not available for public disclosure. However, these formulations might differ from the Marinol formulation currently listed in schedule III. Nonetheless, the firms that have submitted the ANDAs assert that their formulations would meet the approval requirements under 21 U.S.C. 355(j), because, among other things, they have the same active ingredient, strength, dosage form, and route of administration as Marinol, and are bioequivalent to Marinol. Products are bioequivalent if there is no significant difference in the rate and extent to which the active ingredient or active moiety becomes available at the site of drug action. 21 CFR 320.1. There is no requirement under 21 U.S.C. 355(j), or FDA's implementing regulations, that solid oral dosage forms such as capsules that are proposed for approval in ANDAs contain the same inactive ingredients as the listed drug referenced. Thus, for example, a sponsor of an ANDA referencing Marinol could propose for approval a capsule formulated with an inactive ingredient other than sesame oil. The generic drug, therefore, would not fall within the scope of the current regulation. This situation, in which a generic version of a drug would not necessarily fall within the schedule for the referenced listed drug, is unique among the CSA schedules in the following respect. The Marinol formulation listed in schedule III is the only listing in the schedules that has the effect of excluding potential generic versions of the brand name formulation. 7 As indicated above, this came about because DEA did not anticipate that other drug products could be approved by FDA that did not fit the description that was included in the schedules. Moreover, Congress structured the CSA so that there would be no distinction—for scheduling purposes—between brand name drug products and their generic equivalents. The rule being proposed here would ensure that this aspect of the CSA holds true for generic drug products approved under 21 U.S.C. 355(j) that reference Marinol as the listed drug. 7 Generally, substances are listed in the CSA schedules based on their chemical classification, rather than any drug product formulation in which they might appear. Because of this, there have been no other situations in which a slight variation between the brand name drug formulation and the generic drug formulation was consequential for scheduling purposes. In addition, 21 U.S.C. 355(j)(2)(C) permits applicants to petition FDA for approval in an ANDA for a drug product that may differ from the listed drug in certain specified ways, if clinical studies are not necessary to establish the safety and effectiveness of the drug product. Among the types of differences permitted is a change in dosage form. This proposed rule would amend the description in Schedule III to include products referencing Marinol that are either capsules or tablets and that otherwise meet the approval requirements in 21 U.S.C. 355(j). The CSA Scheduling Structure To understand the legal justification for the rule being proposed here, the scheduling scheme established by Congress under the CSA must first be considered. One court has succinctly summarized this scheme as follows: The [CSA] sets forth initial schedules of drugs and controlled substances in 21 U.S.C. 812(c). However, Congress established procedures for adding or removing substances from the schedules (control or decontrol), or to transfer a drug or substance between schedules (reschedule). 21 U.S.C. 811(a). This responsibility is assigned to the Attorney General in consultation with the Secretary of Health and Human Services (“HHS”). *Id.* § 811(b). The Attorney General has delegated his functions to the Administrator of the DEA. 28 CFR 0.100(b). Current schedules are published at 21 CFR 1308.11-1308.15. There are three methods by which the DEA may initiate rulemaking proceedings to revise the schedules:
(1)By the DEA's own motion;
(2)at the request of HHS;
(3)on the petition of any interested party. 21 U.S.C. 811(a); 21 CFR 1308.43(a). Before initiating rulemaking proceedings, the DEA must request a scientific and medical evaluation from HHS and a recommendation. The statute requires the DEA and HHS to consider eight factors with respect to the drug or controlled substance. 21 U.S.C. 811(b), (c). These factors are:
(1)Its actual or relative potential for abuse.
(2)Scientific evidence of its pharmacological effect, if known.
(3)The state of current scientific knowledge regarding the drug or other substance.
(4)Its history and current pattern of abuse.
(5)The scope, duration, and significance of abuse.
(6)What, if any, risk there is to the public health.
(7)Its psychic or physiological dependence liability.
(8)Whether the substance is an immediate precursor of a substance already controlled under this subchapter. 21 U.S.C. 811(c). Although the recommendations of HHS are binding on the DEA as to scientific and medical considerations involved in the eight-factor test, the ultimate decision as to whether to initiate rulemaking proceedings to reschedule a controlled substance is made by the DEA. *See id.* § 811(a), (b). *Gettman* v. *DEA* , 290 F.3d 430, 432 (DC Cir. 2002). The FDA plays an important role within HHS in the development of the HHS medical and scientific determinations that bear on eight-factor analyses referred to above (required under section 811(c) for scheduling decisions). Thus, when it comes to newly developed drug products that contain controlled substances, FDA makes medical and scientific determinations for purposes of both the Food Drug and Cosmetic Act (in connection with decisions on whether to approve drugs for marketing) and the CSA (in connection with scheduling decisions). As explained below, the eight-factor analysis can be expected to yield the same conclusions with respect to a brand name drug product and certain generic drugs referencing that product that meet the approval requirements under 21 U.S.C. 355(j). The ANDA Approval Process The Drug Price Competition and Patent Term Restoration Act of 1984 (known as the “Hatch-Waxman Amendments”), codified at 21 U.S.C. 355, 360cc, and 35 U.S.C. 156, 271, 282, permits the submission of ANDAs for approval of generic versions of approved drug products. 21 U.S.C. 355(j). The ANDA process shortens the time and effort needed for approval by, among other things, allowing the applicant to demonstrate its product's bioequivalence to a drug already approved under a New Drug Application
(NDA)(the “listed” drug) rather than having to reproduce the safety and effectiveness data for that drug. If an ANDA applicant establishes that its proposed drug product has the same active ingredient, strength, dosage form, route of administration, labeling, and conditions of use as a listed drug, and that it is bioequivalent to that drug, the applicant can rely on FDA's previous finding that the listed drug is safe and effective. *See id.* 8 Once approved, an ANDA sponsor may manufacture and market the generic drug to provide a safe, effective, and low cost alternative to the American public. 8 See also Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the “Orange Book”), Intro. at p. vi, (27th ed.). The majority of drugs approved under 21 U.S.C. 355(j) are therapeutically equivalent to the listed drug they reference. This means that the generic drug and the referenced innovator drug are in the same dosage form, contain identical amounts of the active ingredient, and are bioequivalent. Therapeutic equivalents can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling. The key point, for purposes of the rule being proposed here, is that the generic drug can be substituted for the innovator drug with the full expectation that the generic drug will produce the same clinical effect and safety profile as the innovator drug. Consequently, for CSA scheduling purposes, the eight-factor analysis conducted by the FDA and DEA under 21 U.S.C. 811(c) would necessarily result in the same scheduling determination for an approved generic drug product as for the innovator drug to which the generic drug is a therapeutic equivalent. This is because, in conducting the eight-factor analysis, the FDA and DEA would be examining precisely the same medical, scientific, and abuse data for the generic drug product as would be considered for the innovator drug. The same would be true of the innovator drug and a drug product approved pursuant to a petition under 21 U.S.C. 355(j)(2)(C), where the drug approved in the ANDA differs from the listed drug only because it is a tablet and the listed drug is a capsule. As noted earlier, these considerations never previously arose for any other controlled substance because the regulation citing the Marinol formulation is the only scheduling regulation that is drug-product-formulation-specific and thereby (inadvertently) excludes potential generic versions. 9 This unintended result is not consistent with the structure and purposes of the CSA, which generally lists categories of substances in the schedules, rather than product formulations. 10 Thus, by ensuring that generic versions of the Marinol formulation which might be approved by the FDA in the future are in the same schedule as Marinol, the rule being proposed here would make the DEA regulations more consistent with the structure and purposes of the CSA. Moreover, because—from a scientific perspective—the eight-factor analysis for such generic products would lead to the same results as with the innovator drug, this proposed rule would eliminate the needless expenditure of agency resources to conduct redundant eight-factor analyses. (HHS and DEA have already conducted the eight-factor analysis for the Marinol formulation. 11 ) In a similar vein, this proposed rule will eliminate an unnecessary administrative hurdle that could otherwise stand in the way of allowing generic drugs to reach the American consumer without undue delay. 9 When Congress enacted the CSA in 1970, it scheduled codeine and certain other opiates in three different schedules depending on their respective concentrations. See 21 U.S.C. 812(c), schedule II(a)(1), schedule III(d), and schedule V. However, this differential scheduling for opiates does not specify drug product formulation in a manner that would result in a generic version of an opiate drug product being scheduled separately from the innovator drug. 10 See note 9. 11 The last eight-factor analysis for Marinol was completed in 1998, as part of the process of transferring it from schedule II to schedule III. 64 FR 35928 (July 2, 1999). Finally, for additional clarity, the proposed rule will amend 21 CFR 1308.13(g)(1) to change the phrase “U.S. Food and Drug Administration approved product” to “drug product approved for marketing by the U.S. Food and Drug Administration.” Note Regarding This Proposed Scheduling Action In accordance with the provisions of the Controlled Substances Act (21 U.S.C. 811(a)), this action is a formal rulemaking “on the record after opportunity for a hearing.” Such proceedings are conducted pursuant to the provisions of the Administrative Procedure Act (5 U.S.C. 556 and 557). Interested persons are invited to submit their comments, objections or requests for a hearing with regard to this proposal. Persons wishing to request a hearing should note that such requests must be written and manually signed; requests for a hearing will not be accepted via electronic means. Requests for a hearing should be made in accordance with 21 CFR 1308.44 and should state, with particularity, the issues concerning which the person desires to be heard. All correspondence regarding this matter should be submitted to the DEA using the address information provided above. Regulatory Certifications Regulatory Flexibility Act The Deputy Administrator hereby certifies that this rulemaking has been drafted in accordance with the Regulatory Flexibility Act (5 U.S.C. 601-612), has reviewed this regulation, and by approving it certifies that this regulation will not have a significant economic impact on a substantial number of small entities. DEA is hereby proposing to modify the listing of the Marinol formulation in schedule III so that certain generic drug products are also included in that listing. Further, this proposed rule will eliminate an unnecessary administrative hurdle that could otherwise stand in the way of allowing generic drugs to reach the American consumer without undue delay. Executive Order 12866 In accordance with the provisions of the CSA (21 U.S.C. 811(a)), this action is a formal rulemaking “on the record after opportunity for a hearing.” Such proceedings are conducted pursuant to the provisions of 5 U.S.C. 556 and 557 and, as such, are exempt from review by the Office of Management and Budget pursuant to Executive Order 12866, 3(d)(1). Executive Order 12988 This regulation meets the applicable standards set forth in Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform. Executive Order 13132 This rulemaking does not preempt or modify any provision of state law; nor does it impose enforcement responsibilities on any state; nor does it diminish the power of any state to enforce its own laws. Accordingly, this rulemaking does not have federalism implications warranting the application of Executive Order 13132. Unfunded Mandates Reform Act of 1995 This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $120,000,000 or more (adjusted for inflation) in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995. Congressional Review Act This rule is not a major rule as defined by Section 804 of the Small Business Regulatory Enforcement Fairness Act (Congressional Review Act). This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets. List of Subjects in 21 CFR Part 1308 Administrative practice and procedure, Drug traffic control, Narcotics, Prescription drugs. Pursuant to the authority vested in the Attorney General under sections 201, 202, and 501(b) of the CSA (21 U.S.C. 811, 812, and 871(b)), delegated to the Administrator and Deputy Administrator pursuant to section 501(a) (21 U.S.C. 871(a)) and as specified in 28 CFR 0.100 and 0.104, and Appendix to Subpart R, sec. 12, the Deputy Administrator hereby orders that Title 21 of the Code of Federal Regulations, Part 1308, is proposed to be amended as follows: PART 1308—SCHEDULES OF CONTROLLED SUBSTANCES 1. The authority citation for part 1308 continues to read as follows: Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted. 2. Section 1308.13 is proposed to be amended by revising paragraph
(g)to read as follows: § 1308.13 Schedule III.
(g)*Hallucinogenic substances.* (1)(i) Dronabinol in sesame oil and encapsulated in a soft gelatin capsule in a drug product approved for marketing by the U.S. Food and Drug Administration (FDA)—7369
(ii)Any drug product in tablet or capsule form containing natural dronabinol (derived from the cannabis plant) or synthetic dronabinol (produced from synthetic materials) for which an abbreviated new drug application
(ANDA)has been approved by the FDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act which references as its listed drug the drug product referred to in the preceding paragraph (g)(1)(i) of this section.—7369 [Some other names for Dronabinol: (6a R-trans)-6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-6 H-dibenzo [b,d]pyran-1-ol] or (-)-delta-9-(trans)-tetrahydrocannabinol]
(2)[Reserved] Dated: September 17, 2007. Michele M. Leonhart, Deputy Administrator. [FR Doc. E7-18714 Filed 9-21-07; 8:45 am] BILLING CODE 4410-09-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 300 [EPA-HQ-SFUND-2005-0011; FRL-8471-4] National Oil and Hazardous Substances Pollution Contingency Plan; National Priorities List AGENCY: Environmental Protection Agency. ACTION: Notice of intent to delete the Tabernacle Drum Dump Superfund Site from the National Priorities List. SUMMARY: The Environmental Protection Agency
(EPA)Region 2 is issuing this notice of intent to delete the Tabernacle Drum Dump Superfund Site (Site), located in Tabernacle Township, Burlington County, New Jersey from the National Priorities List
(NPL)and requests public comment on this action. The NPL is Appendix B of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP), 40 CFR part 300, which the EPA promulgated pursuant to section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), as amended. The EPA and the State of New Jersey, through the New Jersey Department of Environmental Protection, have determined that responsible parties have implemented all appropriate response actions required. No further operation and maintenance activities or five-year reviews are required at this site. DATES: Comments concerning this site may be submitted on or before October 24, 2007. ADDRESSES: Submit your comments, identified by Docket ID no. EPA-HQ-SFUND-2005-0011, by one of the following methods: • *http://www.regulations.gov.* Follow on-line instructions for submitting comments. • *E-mail:* *tomchuk.doug@epa.gov. * • *Fax:*
(212)637-4429. • *Mail:* Douglas Tomchuk, Remedial Project Manager, U.S. Environmental Protection Agency, Region 2, 290 Broadway, 19th Floor, New York, NY 10007-1866. • *Hand delivery:* Douglas Tomchuk, U.S. Environmental Protection Agency, Region 2, 290 Broadway, 19th Floor, New York, NY 10007-1866. Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information. *Instructions:* Direct your comments to Docket ID no. EPA-HQ-SFUND-2005-0011. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at *http://www.regulations.gov* , including any personal information provided, unless the comment includes information claimed to be Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through *http://www.regulations.gov* or e-mail. The *http://www.regulations.gov* Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going to *http://www.regulations.gov* , your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. 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. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. *Docket:* All documents in the docket are listed in the *http://www.regulations.gov* index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in the hard copy. Publicly available docket materials are available either electronically in *http://www.regulations.gov* or in hard copy at: EPA Region 2 Superfund Records Center, 290 Broadway, Room 1828, New York, New York 10007-1866,
(212)637-4308, *Hours:* 9 a.m. to 5 p.m., Monday through Friday, excluding holidays, by appointment only. Information on the Site is also available for viewing at the Site's information repository located at: Tabernacle Municipal Building, 163 Carranza Road, Tabernacle, New Jersey 08088. FOR FURTHER INFORMATION CONTACT: Douglas Tomchuk, Remedial Project Manager, U.S. Environmental Protection Agency, Region 2, 290 Broadway, 19th Floor, New York, NY 10007-1866, *Telephone:*
(212)637-3956, *Fax:*
(212)637-4429, *E-mail: tomchuk.doug@epa.gov.* SUPPLEMENTARY INFORMATION: Table of Contents I. Introduction II. NPL Deletion Criteria III. Deletion Procedures IV. Basis for Intended Site Deletions I. Introduction The Environmental Protection Agency
(EPA)Region II announces its intent to delete the Tabernacle Drum Dump, located on Carranza Road in Tabernacle Township, Burlington County, New Jersey, from the National Priorities List
(NPL)and requests public comment on this action. The NPL constitutes Appendix B of the NCP, 40 CFR part 300, which EPA promulgated pursuant to section 105 of CERCLA, as amended. The EPA identifies sites that appear to present a significant risk to public health, welfare, or the environment and maintains the NPL as the list of those sites. Sites on the NPL may be the subject of remedial actions financed by the Hazardous Substances Superfund Response Trust Fund (Fund). Pursuant to § 300.425(e)(3) of the NCP, any site deleted from the NPL remains eligible for Fund-financed remedial actions if conditions at the site warrant such action. The EPA will accept comments on the proposal to delete this site for thirty
(30)days after publication of this notice in the **Federal Register** . Section II of this notice explains the criteria for deleting sites from the NPL. Section III discusses procedures that EPA is using for this action. Section IV discusses how the site meets the deletion criteria. II. NPL Deletion Criteria The NCP establishes the criteria the Agency uses to delete sites from the NPL. In accordance with 40 CFR 300.425(e)(l)(i)-(iii), sites may be deleted from the NPL where no further response is appropriate. In making this determination, EPA shall consider, in consultation with the State, whether any of the following criteria have been met:
(i)Responsible parties or other persons have implemented all appropriate response actions required; or
(ii)All appropriate Fund-financed responses under CERCLA have been implemented and no further cleanup by responsible parties is appropriate; or
(iii)The remedial investigation has shown that the release poses no significant threat to public health or the environment and, therefore, taking of remedial measures is not appropriate. Even if a site is deleted from the NPL, where hazardous substances, pollutants, or contaminants remain at the site above levels that allow for unlimited use and unrestricted exposure, EPA will conduct site remedy reviews every five years to ensure that the implemented remedy protects public health and the environment. If new information becomes available which indicates a need for further action, EPA may initiate remedial actions. Whenever there is a significant release from a site deleted from the NPL, the site may be restored to the NPL without the application of the Hazardous Ranking System. III. Deletion Procedures The following procedures were used for the intended deletion of this site:
(1)EPA selected a remedy for this site in a June 30, 1988 Record of Decision (ROD).
(2)The Potentially Responsible Parties
(PRPs)have completed a comprehensive cleanup at the site. The work included the removal and off-site disposal of drums, other containers, contaminated liquids and contaminated soil. Contaminated ground water was extracted, treated and then re-injected into the ground. The ground water cleanup was verified by a monitoring program that lasted five years. In addition, the property where the ground water treatment system was located has been restored in accordance with an approved Site Restoration Plan. No further remedial action is necessary at the Tabernacle Drum Dump site to ensure protection of human health and the environment.
(3)All appropriate responses under CERCLA have been documented in the Final Close Out Report dated June 6, 2007.
(4)The State of New Jersey, through the Department of Environmental Protection, has concurred with the proposed deletion decision;
(5)A notice has been published in the local newspaper and has been distributed to appropriate federal, state and local officials and other interested parties announcing the commencement of a 30 day public comment period for EPA's Notice of Intent to Delete; and
(6)All relevant documents have been made available for public review in the local Site information repositories. Deletion of the Site from the NPL does not itself create, alter, or revoke any individual's rights or obligations. The NPL is designed primarily for informational purposes and to assist Agency management. As mentioned in section II of this Notice, § 300.425(e)(3) of the NCP states that deletion of a site from the NPL does not preclude eligibility for future response actions. For deletion of this Site, EPA's Region 2 office will accept and evaluate public comments on EPA's Notice of Intent to Delete before making a final decision to delete. If necessary, the Agency will prepare a Responsiveness Summary, which will address any significant public comments received during the public comment period. The deletion occurs when the EPA Regional Administrator places a final notice in the **Federal Register** . Generally, the NPL will reflect any deletions in the final update following the Notice. Public notices and copies of the Responsiveness Summary will be made available to local residents by the Region 2 Office. IV. Basis for Intended Site Deletion The following summary provides the Agency's rationale for the proposal to delete this Site from the NPL and the Agency's finding that the criteria in 40 CFR 300.425(e) are satisfied:
(A)Site History The Tabernacle Drum Dump is located in Tabernacle Township, Burlington County, New Jersey. The Site is a wooded one-acre parcel of undeveloped land, bordered to the northwest by farmland and to the south and east by residential properties. The Site is located in the northern region of the New Jersey Pinelands. Between 1977 and 1984 Atlantic Disposal Services, Inc.,
(ADS)disposed of approximately 200 containers on the property. The containers included 55-gallon drums, 5-gallon paint cans and 20-gallon containers, which held solvents, paint sludges and heavy metals. Deterioration and leakage of some of the containers resulted in visible contamination of the soils, and ultimately, contamination of ground water underlying and downgradient of the Site. In September 1983, the Tabernacle Drum Dump site was proposed to the NPL, and the site was approved for inclusion on the NPL in September 1984.
(B)Immediate Actions In February 1984, EPA issued an administrative order to ADS to perform a surface cleanup of the site, along with certain investigations of ground water contamination. ADS completed the surface cleanup of the site in July 1984, which consisted of removing the containers found at the site, 40 cubic yards of material from the drums, eight truck loads of excavated contaminated soil and approximately 3,000 gallons of liquid material. However, ADS did not implement the investigations of the subsurface soils or ground water.
(C)Remedial Investigation/Feasibility Study EPA conducted a Remedial Investigation/Feasibility Study (RI/FS) for the site, beginning with preliminary sampling in July 1985. The Remedial Investigation report found chromium, cyanide and lead in the surface soils above background levels, but below New Jersey soil cleanup levels. In the groundwater, cadmium, chromium, lead, 1,1,1-trichloroethane, 1,1-dichloroethane were found exceeding background levels and Applicable or Revelant and Appropriate Requirements (ARARs). The Remedial Investigation was completed in December 1987.
(D)Selected Remedy Based on the RI/FS, EPA selected a remedy for the Site in a Record of Decision
(ROD)which was signed on June 30, 1988, which included the following major elements: • Installation of additional ground-water monitoring wells to further delineate the extent of the contaminant plume; • Implementation of a ground water monitoring program for downgradient residential wells to delineate the contaminant plume; • Additional soil sampling at the former drum dumping and storage area to confirm previous data which indicated only trace levels of contaminants; • Extraction of the contaminated ground water through pumping followed by on-site treatment and reinjection of the treated effluent into the ground, until federal and state cleanup standards have been attained to the maximum extent practicable; and • Implementation of a ground water monitoring program for a period of five years after site cleanup goals have been achieved.
(E)Remedial Actions The cleanup of the Site was completed through various remedial actions including the removal and off-site disposal of drums, containers and contaminated surface soils, and the extraction of contaminated ground water with treatment and re-injection. The sampling in the former drum dump and storage area, subsequent to the removal action, found only trace levels of contaminants remaining in surface and subsurface soils at the Site (below NJDEP Cleanup Standards for contaminated sites (N.J.A.C. 7:26D)), and therefore no further action was warranted for the soil. The pump and treat system was constructed and subsequently ran from August 30, 1993 to June 21, 1997 at a rate of approximately 7,000,000 gallons per month (160 gallons per minute). The cleanup levels specified in the ROD were 26 parts per billion
(ppb)for 1,1,1-trichlorethane and 2 ppb for 1,1-dichloroethene. A post-construction monitoring program was conducted between July 1997 and July 2001, and found no detections of 1,1,1-trichloroethane in the designated monitoring wells above the detection limit of 1 ppb after October 1999, and no detections above the detection limit of 1 ppb of 1,1 dichloroethene during the post-construction monitoring period.
(F)Operation and Maintenance There are no operations, maintenance or monitoring activities remaining to be performed. All remedial activities, including monitoring, are complete and the site poses no unacceptable risk to human health or the environment. The property utilized for ground water treatment has been restored. All structures and underground piping have been removed, all wells have been properly sealed and vegetation has been re-established. Monitoring of the new plantings and seeding will occur for three growing seasons in accordance with an approved Site Restoration Plan.
(G)Five Year Review A Five-year review of the selected remedy for the Site was signed on September 10, 1998. It found that there are no hazardous substances, pollutants, or contaminants remaining at this site above levels that would allow for unlimited use and unrestricted exposure. The remedy was found to protect public health and the environment and was likely to remain so. No further five-year reviews required and no other engineered, access or institutional controls are needed.
(H)Community Involvement Public participation activities for the Tabernacle Drum Dump site have been satisfied as required in CERCLA section 113(k), 42 U.S.C. 9613(k), and section 117, 42 U.S.C. 9617. The RI/FS, the ROD, as well as other documents and information that EPA relied on or considered in recommending that no further action is necessary at the Tabernacle Drum Dump Site, and that the site should be deleted from the NPL, are available for the public to review at the information repositories.
(I)Site Meets Deletion Criteria One of the three criteria for deletion specifies that EPA may delete a site from the NPL if EPA, in consultation with the State, has determined that responsible parties or other persons have implemented all appropriate response actions required; 40 CFR 300.425(e)(1)(i). EPA, with the concurrence of the State of New Jersey, through the New Jersey Department of Environmental Protection, believes that this criterion for deletion has been met. Consequently, EPA is proposing deletion of this site from the NPL. Documents supporting this action are available at the information repositories in the deletion docket. In a letter dated August 30, 2006, the New Jersey Department of Environmental Protection concurred with EPA that all appropriate CERCLA response actions have been completed at the Tabernacle Drum Dump site and protection of human health and the environment has been achieved. Dated: August 17, 2007. Alan Steinberg, Regional Administrator, Region 2. [FR Doc. E7-18579 Filed 9-21-07; 8:45 am] BILLING CODE 6560-50-P 72 184 Monday, September 24, 2007 Notices DEPARTMENT OF AGRICULTURE Forest Service RIN 0596-AC61 [FSM 2720, FSH 2609.13 and FSH 2709.11] Wind Energy, Proposed Forest Service Directives AGENCY: Forest Service, USDA. ACTION: Proposed directives; request for comment. SUMMARY: The Forest Service proposes to amend its internal agency directives for special use authorizations and wildlife monitoring. The proposed amendments would provide direction and guidance specific to wind energy development on National Forest System
(NFS)lands. These amendments supplement, rather than supplant or duplicate, existing special use and wildlife directives to address issues specifically associated with siting, processing proposals and applications, and issuing special use permits for wind energy uses. The proposed directives would ensure consistent and adequate analyses for evaluating wind energy proposals and applications and issuing wind energy permits. Public comment is invited and will be considered in the development of final directives. DATES: Comments must be received in writing by November 23, 2007. ADDRESSES: Send written comments to Wind Energy Proposed Directives, Attention: Director, Lands Staff, 4th Floor-South, USDA Forest Service, 1400 Independence Avenue, SW., Mailstop 1124, Washington, DC 20250, or by facsimile to 202-205-1604. You may also submit comments by following the instructions at the Federal e-rulemaking portal at *http://www.regulations.gov. * All comments, including names and addresses when provided, will be placed in the record and will be available for public inspection and copying. The public may inspect comments received on the proposed directives in the USDA Forest Service Headquarters located at 201 14th Street, SW., Washington, DC, on business days between 8:30 a.m. and 4:30 p.m. eastern time. Those wishing to inspect comments are encouraged to call ahead to
(202)205-1248 or
(202)205-0895 to facilitate entry into the building. FOR FURTHER INFORMATION CONTACT: Paul Johnson, Minerals and Geology Management,
(703)605-4793, or Julett Denton, Lands Staff,
(202)205-1256. SUPPLEMENTARY INFORMATION: 1. Background The Forest Service is responsible for managing 193 million acres of NFS lands. To date, the Forest Service has issued over 74,000 special use authorizations on NFS lands covering over 180 types of uses. Wind energy uses are governed by the Forest Service's special use regulations at 36 CFR part 251, subpart B. Wind energy proposals and applications are currently processed in accordance with 36 CFR 251.54 and direction in Forest Service Manual
(FSM)2726 and FSH 2709.11 on administration of special uses. These proposed directives would add a new chapter 70, “Wind Energy Uses,” to the Special Uses Handbook, FSH 2709.11, and a new chapter 80, “Monitoring at Wind Energy Sites,” to the Wildlife Monitoring Handbook, FSH 2609.13. These new chapters would supplement, rather than supplant or duplicate, existing special use and wildlife directives. In particular, new chapter 70 would provide direction on siting, processing proposals and applications, and issuing permits for wind energy uses. New chapter 80 would provide specific guidance on wildlife monitoring at wind energy sites before, during, and after construction. The direction in chapter 70 would be similar to the procedures established by the United States Department of the Interior, Bureau of Land Management, for managing wind energy uses on public lands. In addition, the proposed directives would make corresponding revisions to FSM 2726, “Energy Generation and Transmission,” and FSH 2709.11, Chapter 40, “Special Uses Administration.” 2. Need for Wind Energy Directives The emphasis on development of alternative energy sources in the Energy Policy Act of 2005 and increasing industry interest in development of wind energy facilities on NFS lands have prompted the Forest Service to issue proposed directives that address issues specifically associated with siting wind energy uses, processing wind energy proposals and applications, and issuing wind energy permits. The proposed directives would provide a consistent framework and terminology for making decisions regarding proposals and applications for wind energy uses. Specifically, the directives would provide guidance on siting wind energy turbines, evaluating a variety of resource interests, and addressing issues specifically associated with wind energy in the special use permitting process. These issues include potential effects on scenery, national security, significant cultural resources, and wildlife, especially migratory birds and bats. Summary of Changes The proposed directives address proposals and applications for and issuance of two types of wind energy permits:
(1)Site testing and feasibility permits for the collection of data on the wind resource, and
(2)permits for construction and operation of a wind energy facility. The proposed directives also address competitive interest in wind energy uses, land use fees for wind energy permits, and potential effects from wind energy uses on wildlife, scenery, significant cultural resources, and national security. The proposed directives follow the sequence for processing special use proposals and applications and issuing permits in 36 CFR 251.54. Since the proposed directives supplement existing special use regulations and directives and wildlife monitoring directives, reviewers may find it helpful to become familiar with the special use regulations at 36 CFR part 251, subpart B, and existing direction in Forest Service Handbook
(FSH)2709.11, chapter 10 and chapter 40, and FSH 2609.13 before reviewing the proposed directives. Section-by-Section Analysis Proposed Revisions to FSM 2726, “Energy Generation and Transmission” The proposed directives would amend FSM 2726 to include policy statements about the goals of the Forest Service when authorizing wind energy facilities on NFS lands, as well as responsibility for and direction on how to achieve those goals. Proposed Revisions to FSH 2709.11, Chapter 40, “Special Uses Administration” The proposed revisions to FSH 2709.11, Chapter 40, would clarify that the wind energy designation pertains only to facilities using wind to generate electric power. Proposed Revisions to FSH 2709.11, Chapter 70, “ Wind Energy Uses” The proposed directives would add a new Chapter 70, entitled “Wind Energy Uses,” to FSH 2709.11. The salient sections of the new chapter are discussed below. Section 70.5—Definitions New Chapter 70 would include the following definitions: *Adaptive Management.* A management system that incorporates emerging science and monitoring into decision-making and ongoing operations. *Minimum Area Permit.* A site testing and feasibility permit covering the minimum area necessary, but no more than five acres, for construction, operation, and maintenance of a single meteorological tower
(MET)to study the wind resource. *Nacelle.* The housing that protects the major components (such as the generator and gear box) of a wind turbine. *Plan of Development.* A document that describes a proposed wind energy facility and how it will be constructed, operated, and decommissioned. *Project Area Permit.* A site testing and feasibility permit covering more than five acres for construction, operation, and maintenance of multiple METs to study the wind resource. *Significant Cultural Resource.* A National Historic Landmark or a cultural resource, including historic, prehistoric, archaeological, or an architectural site, structure, place, or object that is important to the public or scientific community or a site or place of traditional cultural or religious importance to a social or cultural group, which is eligible for listing or listed in the National Register of Historic Places. *Site Plan.* A scaled, two dimensional graphic representation of the location of all proposed wind turbines, buildings, service areas, roads, structures, and site boundaries for a wind energy facility. These proposed elements are displayed in relationship to existing site features such as topography, major vegetation, water bodies, and constructed elements on one or more drawings. *Species of Management Concern.* Federally listed threatened and endangered species, candidates for listing as threatened or endangered, Forest Service species of concern, species of interest, species of high public interest, and management indicator species, any one or more of which may include species of wildlife, fish, or rare plants and, for purposes of this directive, generally include migratory bird and bat species because of their susceptibility to collision with wind energy improvements during migration. *String.* A number of wind turbines oriented in close proximity to one another that are usually sited in a line, such as along a ridgeline. Section 71—Types of Wind Energy Permits This section would address the two principal types of permits for wind energy uses:
(1)A site testing and feasibility permit (sec.75.1) and
(2)a permit for construction and operation of a wind energy facility (sec.75.2). A site testing and feasibility permit would be issued for the installation of meteorological towers
(MET)to gather data on the wind resource and to determine the feasibility of producing wind energy. A site testing and feasibility permit would be issued for up to 5 years. A proponent for a permit for construction and operation of a wind energy facility would have to submit data collected under a site testing and feasibility permit or otherwise establish the feasibility of producing wind energy at a particular site. A permit for construction and operation of a wind energy facility would be issued for up to 30 years. Section 72—Wind Energy Proposals This section woud apply to proposals for all types of wind energy permits. Section 72.1—Pre-Proposal Meetings This section would provide direction specific to wind energy uses regarding pre-proposal meetings between proponents of wind energy uses and the Forest Service. Section 72.2—Federal Interagency Coordination This section would advise proponents for all wind engery permits of the need to file a feasibility proposal with the Federal Aviation Administration
(FAA)to obtain an early assessment of whether their proposed wind energy improvements would have any implications for civilian aviation. Section 72.3—Screening of Proposals This section would provide direction on screening of proposals for wind energy uses. Section 72.31—Siting Considerations This section would outline the siting considerations that apply to screening of proposals for all types of wind energy permits (36 CFR 251.54(e)). This section would not apply to processing of wind energy special use applications, which would be governed by section 73 of the proposed directives. Section 72.31a—General Considerations This section would address general siting considerations for wind energy uses. Specifically, this section would ensure that wind energy proposals are consistent or can be made consistent with the applicable land management plan (36 CFR 251.54(e)(1)(ii)) and follow procedures for special uses management in FSM 2700. The specific factors that would be considered for wind energy planning include
(1)The suitability of the site for the intended use, which may be influenced by scenery, soil, or geological factors; the presence of significant cultural resources, federally listed fish, wildlife, or rare plant habitat; known and important bird or bat migration routes; or other environmental or human resource considerations, and
(2)the wind resource, including existing wind speed and direction at proposed locations. Section 72.31b—Recreational and Scenery Considerations This section would enumerate the considerations that would be given to recreational settings and experiences and scenery in making siting decisions regarding wind energy uses. The Recreation Opportunity Spectrum
(ROS)(FSM 2311.1) would be used to identify the recreational activities, settings, and facilities in the area proposed for a wind energy use. In addition, consideration would be given to how recreational settings could be affected by noise and lighting impacts; dust or air quality impacts; and road construction. The Scenery Management System
(SMS)(FSM 2380) would be used to assess the value of scenery in the project area, the experience scenery provides relative to competing resource demands, and the impacts to scenery associated with project construction and operation. Section 72.31c—Community Tourism Considerations This section would address community tourism considerations in siting wind energy uses. Section 72.31d—Public Access Considerations This section would address public access considerations in siting wind energy uses. Section 72.31e—Wildlife, Fish, and Rare Plant Considerations This section would ensure that proponents avoid locating METs and wind energy facilities in sensitive habitats or in areas where ecological resources are known to be sensitive to human activities or in documented bird or bat migration corridors. Additionally, this section would ensure that proponents, to the maximum extent possible, avoid proposing sites with a high incidence of fog and mist and install facilities to avoid disruption of critical wildlife activities. Section 73—Wind Energy Applications. Section 73.1—Application Requirements for All Wind Energy Permits. Section 73.11—Design Requirements. Section 73.11a—Wildlife, Fish, and Rare Plant Considerations This section would provide direction on design requirements for improvements addressed in wind energy applications. Specifically, this section would require the authorized officer to ensure that in designing improvements to be authorized under all types of wind energy permits, applicants
(1)avoid guy wires on METs to the maximum extent possible;
(2)locate wind turbines, roads, and ancillary facilities in the least environmentally sensitive areas;
(3)to the maximum extent possible, avoid placing wind turbines in areas with a high incidence of fog and mist;
(4)avoid, minimize, or mitigate the potential for bird and bat collisions by configuring wind turbines to avoid landscape features known to attract migrating wildlife, if site studies show that placing wind turbines in that location would have adverse impacts;
(5)avoid placing wind turbines near bat hibernation, breeding, and maternity colonies; in important migration corridors; or in flight paths between colonies and feeding areas;
(6)use designs for wind energy structures, including utility poles and wires, that discourage use as perching or nesting substrates for birds and bats; and
(7)where possible, bury utility and distribution lines to minimize visual disturbance and impacts on wildlife, in a manner that minimizes additional surface disturbance. Use existing utility corridors and structures to the extent possible to avoid the development of new infrastructures. Section 73.11b—Scenery Management This section would provide direction on scenery management in connection with wind energy applications. For example, this section would require the authorized officer to ensure that wind energy applicants
(1)limit MET height to the minimum necessary for proper functioning;
(2)integrate wind turbine arrays and design into the surrounding landscape and meet the scenic integrity objectives of the applicable land management plan; where appropriate, consider turbine clustering;
(3)use tubular towers, and non-reflective Forest Service approved finishes;
(4)address proportion and color of wind turbines;
(5)consult appropriate Agriculture and Forest Service direction when planning and designing associated structures and facilities;
(6)avoid placing substations or large buildings at high elevations and along skylines that are visible to the public and conceal these structures or make them as inconspicuous as possible; and (7), where possible, bury distribution lines to minimize visual disturbance. Section 73.11c—Noise Management This section would require the authorized officer to ensure that in designing wind energy improvements, applicants minimize noise where possible and to the extent feasible, and minimize to the maximum extent possible the amplitude of wind turbine and associated generator noise. Specifically, the authorized officer would ensure that, when possible,
(1)applicants restrict noise to 10 decibels above background noise levels at nearby residences and campsites and near wildlife habitat to avoid habitat abandonment or disruption of reproductive activities or hibernation and other sensitive areas;
(2)compare noise measurements taken during wind turbine operation with background noise levels taken during the same time of day; and,(3) where possible, minimize wind turbine noise through the use of acoustic shielding in nacelles and associated facilities. Section 73.11d—Lighting This section would require the authorized officer to ensure that in designing wind energy improvements, applicants reduce the attraction of bats and migratory birds to wind turbines and towers by
(1)using the minimum amount of warning lighting required by the FAA;
(2)unless otherwise required or requested for safety, using the minium number and intensity of white strobe lights at night, with the minumum number of flashes per minute specified by the FAA;
(3)avoiding use of solid or pulsating red incandescent lights;
(4)down-shielding security lighting for facilities and equipment to keep light within the site boundaries; and
(5)designing the site to minimize or eliminate the need for security lights. Section 73.12—Public Outreach This section would address public outreach by wind energy applicants. Section 73.2—Application Requirements for a Pemit for Construction and Operation of a Wind Energy Facility This section would require the authorized officer to ensure that applicants for a permit for construction and operation of a wind energy facility submit a study plan, plan of development, and site plan. Applicants for a site testing and feasibility permit would have to submit a study plan, plan of development, and site plan (sec. 75.1). Section 73.21—Study Plans This section would enumerate the requirements for a study plan. The studies described in the study plan would enable the authorized officer to evaluate the application fully during environmental analysis. Section 73.22—Plan of Development This section would enumerate the requirements for a plan of development (POD). A POD would establish that a wind energy site is consistent with the standards and guidelines in the applicable land management plan, provides for the needs of the public, and facilitates the safe, orderly development of a wind energy site. A POD would be used to develop the proposed action for purposes of environmental analysis for a permit for construction and operation of a wind energy facility. Section 73.23—Site Plan This section would enumerate the requirements for a site plan. A site plan would document the location of all proposed facilities, including the location of wind turbines, buildings, service areas, roads, office and maintenance structures, site boundaries, and any area within the proponent's proposed permit boundary which the Forest Service has excluded from development. Section 74—Requirements for Processing Wind Energy Applications Section 74.1—Effects on Species of Management Concern This section would provide guidance on how to assess effects on wildlife during the evaluation of proposed wind energy uses. As applicable, the authorized officer would consider
(1)in the absence of intensive survey efforts, each potentially affected species with range overlaps in the proposed area to be present in that area;
(2)the status of bats and birds as continental migrant, semi-migrant, regional migrant, or year-round resident species; unique landscape features that may attract migrating birds and bats to the area; migration stopover areas; and bird and bat susceptibility to mortality from collision with or electrocution by the proposed wind energy facilities during migration or movement; and
(3)for resident species and migrants, loss of or disturbance to critical roosting, nesting, or foraging habitat; loss of ecologically significant habitats; and habitat fragmentation, edge effects, and mortality from collision with or electrocution by wind energy improvements. Section 74.2—Applications Involving Lands Under the Jurisdiction of Multiple Agencies This section would provide for coordination and address applicable processing requirements for applications involving lands under the jurisdiction of multiple agencies. Section 74.3—Proprietary Information This section would address withholding and use of proprietary data collected during the term of a site testing and feasibility permit. Section 74.4—Change in Ownership of an Applicant This section would address application procedures if there is a change in ownership of an applicant with a pending wind energy application. Section 74.5—Cost Recovery Requirements This section would address cost recovery requirements associated with wind energy applications and permits. Section 75—Wind Energy Permits Section 75.1—Site Testing and Feasibility Permits This section would require the authorized officer to determine whether a monitoring plan is needed for a site testing and feasibility permit, and if so, the contents of the plan, based on the National Environmental Policy Act decision document. If a monitoring plan is not needed, this section would require the authorized officer to encourage the holder to conduct monitoring of adverse effects on wildlife. This section cross-references the new chapter in the FSH on wildlife monitoring (FSH 2609.13, chapter 80). The results of monitoring could facilitate processing an application for a permit for construction and operation of a wind energy facility. This section also would address key terms of a site testing and feasibility permit. Specifically, the holder of a site testing and feasibility permit would have to collect all information and complete all studies needed to process an application for construction and operation of a wind energy facility. If METs were not operational within 2 years after issuance of the permit, the permit would terminate. Furthermore, if MET test results are not reported to the Forest Service within 3 years after issuance of the permit, the permit would terminate, unless a request for an extension is submitted at least 6 months before termination and is approved by the authorized officer. The authorized officer could approve up to 2 additional years for site testing and feasibility (up to the maximum permit term of 5 years) if the authorized officer determined that the holder had shown due diligence in site testing and feasibility. This section also would provide that issuance of a site testing and feasibility permit would not ensure issuance of a permit for construction and operation of a wind energy facility. Section 75.11—Types of Site Testing and Feasibility Permits This section would enumerate the requirements for issuance of the two types of site testing and feasibility permits: minimum area permits and project area permits. Multiple minimum area permits could be issued for a single area if it could accommodate more than one MET. Only one project area permit would be issued for each study area. Proponents for a project area permit would be required to justify the number of METs and acreage they are proposing to use. Section 75.12—Determination of Competitive Interest Forest Service special use regulations provide that when there is one or more unsolicited proposals and the authorized officer determines that competitive interest exists, the Forest Service must issue a prospectus (36 CFR 251.58(c)(3)(ii)). Minimum area permits would be issued on a first-come, first-served basis and only for the minimum acreage necessary for the construction and maintenance of authorized equipment and facilities, but no more than 5 acres. Therefore, there would be no competition for minimum area permits, and the authorized officer would not need to determine whether competitive interest exists in minimum area permits. Project area permits, however, would be issued for a single study area that is larger than what is required for construction and maintenance of the authorized equipment and facilities, thereby excluding other proponents for site testing and feasibility permits. Consequently, there could be competitive interest in project area permits, and they would require a determination of competitive interest. Proposed section 75.12, paragraph 2a, would provide guidance on determining competitive interest for project area permits and, if it exists, on issuance of a prospectus in accordance with FSM 2712.1. Proposed section 75.12, paragraph c, would provide that the holder of a project area permit has an interest in the project area, which is limited to precluding other site testing and feasibility permits during the term of the project area permit and precluding competition for a wind energy facility. The holder of a project area permit would have to obtain a separate permit for construction and operation of a wind energy facility. The Forest Service would retain the right to authorize other compatible uses of National Forest System lands covered by a project area permit. Section 75.13—Site Testing and Feasibility Permit Form This section would prescribe the form and use code for site testing and feasibility permits. Section 75.2—Permits for Construction and Operation of a Wind Energy Facility Section 75.21—Pre-Authorization Requirements This section would enumerate the prerequisites for issuance of a permit for construction and operation of a wind energy facility. Specifically, the applicant would have to submit
(1)Documentation that construction and operation of a wind energy facility will not hinder national security, military readiness and training areas, radar and electronic security, and military and civilian airspace;
(2)a complete POD;
(3)a final site plan revised to reflect the NEPA decision document for the project;
(4)an annual operating plan that addresses specific requirements during the construction and operational phases of the wind energy facility; and
(5)a monitoring plan prepared in accordance with FSH 2609.13, Chapter 80. Section 75.22—Authorization of Wind Energy Facilities This section would address key terms in a permit for construction and operation of a wind energy facility. In particular, the permit would terminate if construction had not commenced within 2 years after issuance of the permit and if wind turbines were not operational within 5 years after issuance of the permit. The permit holder would have to obtain a construction bond for site restoration upon completion of construction. Additional bonding could be required at the discretion of the authorized officer. Section 76—Land Use Fees Section 76.1—Land Use Fees for Site Testing and Feasibility Permits This section would provide instruction on how to calculate the annual land use fee for the two types of site testing and feasibility permits. The land use fee for a minimum area permit would be the Regional minimum fee (FSH 2709.11, section 31.51a) or a minimum of $100 for each MET or instrumentation facility, whichever is higher. An additional land use fee for the acreage authorized would not be charged. The land use fee for a project area permit would be determined by appraisal of the authorized use, in accordance with FSH 2709.11, section 31.1. Section 76.2—Land Use Fees for Permits for Construction and Operation of a Wind Energy Facility This section would specify how to calculate the land use fee for permits for construction and operation of a wind energy facility. During the construction phase, the land use fee would be based on the total acreage of National Forest System lands covered by the permit and would be determined by appraisal of the authorized use, in accordance with FSH 2709.11, section 31.1. During the operational phase, the land use fee would be based on the market value of the authorized use, determined by appraisal in accordance with FSH 2709.11, section 31.1, or some other valuation method recommended by the Regional Appraiser. Section 76.3—Land Use Fee Updates This section would provide for annual updates to the land use fee for all wind energy permits. Section 77—Administration of Wind Energy Permits This section would apply to all types of wind energy permits. Section 77.1—General Administration This section would provide for administration of wind energy permits in accordance with the applicable land management plan and the terms and conditions of the permit. Permit holders would be responsible for technical inspections and administrative duties associated with wind energy facilities. Section 77.2—Inspections This section would ensure that holders provide annual technical inspection reports of METs and other wind energy equipment covered by their permit to ensure that the equipment is operating in accordance with the operating plan, the permit, and applicable federal and state requirements; certified inventory statements are accurate; and the equipment is secure, safe, and otherwise properly operated and maintained. In addition, the authorized officer would have to ensure that the holder complies with FAA lighting requirements. Section 77.3—Construction Requirements The section would specify requirements for construction of a wind energy facility. Specifically, this section would require the authorized officer to ensure that holders
(1)minimize the area disturbed by site testing and feasibility and construction of a wind energy facility;
(2)conduct site restoration as soon as possible after completion of construction to minimize habitat conversion and to expedite habitat recovery;
(3)use dust abatement techniques;
(4)use explosives only at specified times and at specified distances from sensitive wildlife and streams and lakes; and
(5)schedule installation of MET towers to avoid disruption of wildlife reproductive activities. Section 77.4—Operational Requirements This section would address requirements for operation of a wind energy facility. In particular, this section would require the authorized officer to ensure that holders
(1)completely repair, replace, or remove inoperative wind turbines;
(2)activate security lights through the use of motion detectors;
(3)repair or replace inoperative downshielding for lighting;
(4)have sound-control devices on all equipment;
(5)control noxious weeds and invasive species;
(6)Develop an integrated pest management plan if pesticides are used at the site; and
(7)use adaptive management as appropriate to respond to results from monitoring of impacts on species of management concern and their habitat. Section 77.5—Site Restoration Upon Discontinuation of the Authorized Use This section would address site restoration upon discontinuation of wind energy uses. Upon revocation of a wind energy permit or termination of a wind energy permit without renewal of the authorized use, the authorized officer would have to ensure that holders remove the authorized facilities, decommission access roads, and reestablish predevelopment vegetation cover, composition, configuration, and structural characteristics, unless otherwise determined by the authorized officer. Proposed FSH 2609.13, Chapter 80, “Wildlife Monitoring at Wind Energy Sites” The proposed directive would add a new Chapter 80, entitled “Wildlife Monitoring at Wind Energy Sites” to FSH 2609.13. The new chapter would provide direction on wildlife monitoring at sites that have been identified for potential wind energy development. The salient sections of the new chapter are discussed below. Section 81—Monitoring Plans This section would require the development of a monitoring plan for every species or group of species with similar monitoring objectives. The monitoring plan would state the plan objectives, the target species, the selected monitoring measure(s), the sampling design, data collection methods, the anticipated methods of analysis, and expected reports. The sampling design section would include the seasons when monitoring will be performed, the length of time between monitoring intervals, and the anticipated length of the entire monitoring program. To the extent possible, monitoring plans would be designed or reviewed by an interagency committee of wildlife experts. Section 82—Monitoring Objectives This section would provide guidance on the primary objectives of monitoring plans:
(1)Monitoring changes in wildlife presence before and after the establishment of a wind energy facility;
(2)monitoring mortality rates and associated factors post-construction, and
(3)the need to appropriately address both direct and indirect effects. Endangered and threatened species and other federally protected species, such as bald and golden eagles and migratory birds, would be included in a monitoring plan, as appropriate. Bats would also be included due to their known sensitivity to wind energy developments, along with other species that are of management concern or of high public interest. Section 82.1—Monitoring Wildlife Presence and Abundance This section would provide guidance on how to monitor so that environmental changes due to the construction and operation of a wind energy facility affect wildlife presence or abundance and activity levels can be determined. If data from monitoring indicates that wildlife presence or abundance has changed due to the construction and operation of a wind energy facility, then the information would be used to develop mitigation measures and modify stipulations in the holders operating plan to reduce adverse effects to wildlife. The use of the Before-After-Control-Impact
(BACI)study design would be recommended as an effective approach to meet this objective (Anderson *et al.* 1999). The BACI design is applicable when the monitoring objective is to look for treatment effects, which in the present context, is the construction and operation of a wind energy facility. Section 82.2—Monitoring Mortality This section would provide guidance on post construction mortality monitoring, to determine, to the extent possible, the factors associated with changes in mortality rates, in order to minimize adverse effects to wildlife. The authorized official would determine the length of term for post construction mortality monitoring. To the maximum extent possible, post-construction mortality monitoring would last not less than three years and would occur during multiple seasons. If sampling every turbine regularly would be cost prohibitive, then a subset of turbines may be sampled. The frequency (how often searches should occur) and intensity (amount of area searched based on number of turbines) of mortality searches would vary depending on the site-specific scavenging and decomposition rates of carcasses. If those rates are high, mortality searches would need to be conducted daily, at least during periods of high mortality (such as during bird/bat migratory periods). If removal rates are low, then searches would be conducted every other day or every three days. The holder would be authorized for promptly notifying the authorized official when an endangered or threatened species or bald or golden eagle is found. Other migratory bird species and other species would be reported in progress reports to the authorized official at intervals specified in the monitoring plan. An annual report would be prepared by the holder which summarizes each year's survey effort. The annual report would be used to set the terms and conditions of the next year's operating plan, including plans for mitigation of turbine impacts. Section 84—Adaptive Management Adaptive management is a system that is designed to incorporate emerging science and monitoring into the decisionmaking process. As data from monitoring emerges, management strategies would change or adapt in response to the newly available information and changing circumstances. The purpose of monitoring wildlife at wind energy facilities would be to ensure that these facilities do not have long-term, unacceptable impacts to wildlife. Pre-construction monitoring would be designed to provide site-specific information on wildlife responses that could be used in an adaptive management context to ensure that the siting of wind turbines (location and configuration) in the project area is done in a manner that reduces potential impacts to wildlife. Post-construction monitoring would be designed to provide site-specific information on wildlife responses that could be used in an adaptive management context to alter the structure or operation of the facility in a manner that reduces those impacts. 3. Regulatory Certifications Environmental Impacts Section 31.12, paragraph 2, of FSH 1909.15 (67 FR 54622, August 23, 2002) excludes from documentation in an environmental assessment or environmental impact statement “rules, regulations, or policies to establish Service-wide administrative procedures, program processes, or instructions.” The agency has concluded that the proposed special use and wildlife monitoring directives fall within this category of actions and that no extraordinary circumstances exist which would require preparation of an environmental assessment or environmental impact statement. Regulatory Impact The proposed directives have been reviewed under USDA procedures and Executive Order 12866, as amended by E.O. 13422, on regulatory planning and review. The Office of Management and Budget
(OMB)has determined that the proposed directives are not significant. Accordingly, the proposed directives are not required to be reviewed by OMB. Moreover, the proposed directives have been considered in light of the Regulatory Flexibility Act (5 U.S.C. 602 *et seq.* ). It has been determined that the proposed directives would not have a significant economic impact on a substantial number of small entities as defined by the act because the proposed directives would not impose record-keeping requirements on them; would not affect their competitive position in relation to large entities; and would not affect their cash flow, liquidity, or ability to remain in the market. The proposed directives would have no direct effect on small businesses. The proposed directives merely clarify existing requirements that apply to processing special use proposals and applications and issuing permits for wind energy uses. No Takings Implications The proposed directives have been analyzed in accordance with the principles and criteria contained in Executive Order 12630. It has been determined that the proposed directives would not pose the risk of a taking of private property. Civil Justice Reform The proposed directives have been reviewed under Executive Order 12988 on civil justice reform. After adoption of the proposed directives,
(1)all State and local laws and regulations that conflict with the proposed directives or that impede their full implementation would be preempted;
(2)no retroactive effect would be given to the proposed directives; and
(3)administrative proceedings would not be required before parties could file suit in court challenging their provisions. Unfunded Mandates Pursuant to Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538), which the President signed into law on March 22, 1995, the agency has assessed the effects of the proposed directives on state, local, and tribal governments and the private sector. The proposed directives would not compel the expenditure of $100 million or more by any state, local, or tribal government or anyone in the private sector. Therefore, a statement under section 202 of the act is not required. Federalism and Consultation and Coordination With Indian Tribal Governments The agency has considered the proposed directives under the requirements of Executive Order 13132 on federalism and has determined that the proposed directives conform with the federalism principles set out in this Executive order; would not impose any compliance costs on the states; and would not have substantial direct effects on the states, the relationship between the federal government and the states, or the distribution of power and responsibilities among the various levels of government. Therefore, the agency has determined that no further assessment of federalism implications is necessary. Moreover, these proposed directives do not have tribal implications as defined by Executive Order 13175, entitled “Consultation and Coordination With Indian Tribal Governments,” and therefore advance consultation with tribes is not required. Energy Effects The proposed directives have been reviewed under Executive Order 13211 of May 18, 2001, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.” It has been determined that the proposed directives would not constitute a significant energy action as defined in the Executive order. To the contrary, the proposed directives could have a positive, rather than a negative effect on the supply, distribution, or use of energy to the extent the proposed directives provide direction on processing proposals and applications and issuing special use authorizations for wind energy uses. Controlling Paperwork Burdens on the Public The proposed directives do not contain any record-keeping or reporting requirements or other information collection requirements as defined in 5 CFR part 1320 that are not already required by law or not already approved for use. Accordingly, the review provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ) and its implementing regulations at 5 CFR part 1320 do not apply. Text of Proposed Directives Reviewers may obtain a copy of the proposed revisions to the FSM and FSH from the address cited in the addresses section above or from the Forest Service home page on the World Wide Web at: *http://www.fs.fed.us/recreation/permits/energy.htm.* Dated: September 6, 2007. Sally Collins, Associate Chief, Forest Service. [FR Doc. E7-18715 Filed 9-21-07; 8:45 am] BILLING CODE 3410-11-P DEPARTMENT OF COMMERCE [Docket No.: 070703259-7518-02] Privacy Act of 1974: System of Records AGENCY: Department of Commerce. ACTION: Notice to amend all Privacy Act System of Records. SUMMARY: In accordance with the President's Identity Theft Task Force's Strategic Plan, the Department of Commerce (Commerce) publishes this notice to announce the effective date of a new routine use to be added to all Privacy Act System of Records. DATES: The proposed new routine use becomes effective on September 24, 2007 ADDRESSES: For a copy of the system of records please mail requests to Brenda Dolan, U.S. Department of Commerce, Room 5327, 1401 Constitution Avenue, NW., Washington, DC 20230, 202-482-4258, *BDolan1@doc.gov* . FOR FURTHER INFORMATION CONTACT: Brenda Dolan, U.S. Department of Commerce, Room 5327, 1401 Constitution Ave., NW., Washington, DC 20230. SUPPLEMENTARY INFORMATION: On August 10, 2007, the Commerce published and requested comments on a proposed new routine use to be added to all Privacy Act System of Records. The new routine use for all Commerce systems of records permits disclosure to appropriate persons or entities for purposes of response and remedial efforts in the event of a suspected or confirmed breach of the data contained in the systems. No comments were received in response to the request for comments. By this notice, the Department is adopting the new routine use as final without changes effective September 25, 2007. Dated: September 18, 2007. Brenda Dolan, U.S. Department of Commerce, Freedom of Information/Privacy Act Officer. [FR Doc. E7-18750 Filed 9-21-07; 8:45 am] BILLING CODE 3510-17-P DEPARTMENT OF COMMERCE International Trade Administration [A-580-834] Stainless Steel Sheet and Strip in Coils from the Republic of Korea; Rescission of Antidumping Duty Administrative Review AGENCY: Import Administration, International Trade Administration, Department of Commerce. EFFECTIVE DATE: September 24, 2007. FOR FURTHER INFORMATION CONTACT: Irina Itkin, AD/CVD Operations, Office 2, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW, Washington, DC 20230; telephone:
(202)482-0656. SUPPLEMENTARY INFORMATION: Background On July 3, 2007, the Department of Commerce (the Department) published in the **Federal Register** a notice of opportunity to request an administrative review of the antidumping duty order on stainless steel sheet and strip in coils from the Republic of Korea (Korea) for the period July 1, 2006, through June 30, 2007. *See Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation; Opportunity to Request Administrative Review* , 72 FR 36420 (July 3, 2007). On July 30, 2007, DaiYang Metal Co., Ltd. (DMC), a Korean producer/exporter, requested a review of the antidumping duty order on stainless steel sheet and strip in coils from Korea in accordance with 19 CFR 351.213(b)(2). On August 20, 2007, the Department initiated an administrative review for DMC. *See Initiation of Antidumping and Countervailing Duty Administrative Reviews and Request for Revocation in Part* , 72 FR 48613, 48614 (Aug. 24, 2007). Rescission of Review On August 23, 2007, DMC withdrew its request for review in accordance with 19 CFR 351.213(d)(1). Section 351.213(d)(1) of the Department's regulations requires that the Secretary rescind an administrative review if a party requesting a review withdraws the request within 90 days of the date of publication of the notice of initiation. Therefore, because DMC's request for an administrative review was timely withdrawn and the Department received no other requests for an administrative review of the antidumping duty order on stainless steel sheet and strip in coils from Korea, we are rescinding this review. Assessment The Department will instruct U.S. Customs and Border Protection
(CBP)to assess antidumping duties on all appropriate entries. Antidumping duties shall be assessed at the rate equal to the cash deposit of estimated antidumping duties required at the time of entry, or withdrawal from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(1)(i). The Department will issue appropriate assessment instructions directly to CBP within 15 days of publication of this notice. This notice is published in accordance with section 751 of the Tariff Act of 1930, as amended, and 19 CFR 351.213(d)(4). Dated: September 17, 2007. Stephen J. Claeys, Deputy Assistant Secretary for Import Administration. [FR Doc. E7-18782 Filed 9-21-07; 8:45 am] BILLING CODE 3510-DS-S DEPARTMENT OF COMMERCE International Trade Administration Clean Energy Trade Mission, China and India, January 8-17, 2008 AGENCY: International Trade Administration, Department of Commerce. ACTION: Notice. SUMMARY: The United States Department of Commerce is organizing a Clean Energy Trade Mission to China and India, January 8-17, 2008. The trade mission will target a broad range of clean energy technologies such as renewable energy, biofuels, energy efficiency, clean coal, and distributed generation, and be led by Assistant Secretary of Commerce David Bohigian. ITA seeks to match participating U.S. companies with prescreened partners, agents, distributors, representatives, licensees or retailers in each of these important sectors. In addition to one-on-one business meetings, the agenda will also include meetings with national and local government officials, networking opportunities, country briefings, and site visits. This mission builds on the first U.S. Clean Energy Technologies Trade Mission, which took place in April 2007 and brought 17 U.S. companies to China and India. The trade mission takes place within the context of both the President's new international framework on climate change, energy security, and economic growth involving the 15 major economies (the Global-15), as well as the Asia-Pacific Partnership on Clean Development and Climate (APP). On May 31, 2007, President Bush announced an effort to develop and implement the Global-15 framework by 2012, which would complement the current United Nations Framework Convention on Climate Change and advance the APP. The APP is a public-private partnership in which member countries work together to facilitate commercial deployment of technologies that reduce greenhouse gas emissions and enhance energy security. DATES: Recruitment will begin immediately and will close on November 5, 2007. The Trade Mission will take place January 8-17, 2008. FOR FURTHER INFORMATION CONTACT: Justin Rathke, U.S. Department of Commerce, E-mail: *cleanenergymission@mail.doc.gov* , Telephone: 202-482-7916, Mission Web site: *http://www.export.gov/cleanenergymission.* SUPPLEMENTARY INFORMATION: Commercial Setting China To decrease its dependence on traditional fossil energy, China seeks to lower its share of fossil fuel consumption in its energy mix and increase its use of alternative energy sources over the next five years. Recently, China unveiled an energy strategy as part of its Eleventh Five-Year Plan (2006-2010). The plan aims to double the country's renewable energy supply by 2020. In another promising move, the Chinese Government passed the Law on Renewable Energy, which seeks to promote cleaner energy technologies and seeks to increase renewable energy to 10 percent of the country's electricity consumption by 2020 (up from roughly 3 percent in 2003). This law is partly responsible for the increase in new renewable energy projects, particularly in the areas of wind, solar, and biomass. Achieving the targets for wind energy alone (30 GW from 1.2 GW in 2005) will require $21-28 billion in investment. China invested $7 billion in renewable energy capacity in 2005. More recently, China announced its first national plan to address climate change. The plan calls for a 20 percent reduction in energy consumption per unit of GDP by 2010 while increasing the use of renewable energy. The Chinese Government specified wind, nuclear and hydropower, as well as more energy-efficient coal-fired plants, as the technology approaches that it would use to achieve the reductions. All these initiatives underscore China's intention to deploy cleaner and more efficient technologies. U.S. technology providers with accurate market information and a sound business strategy have the potential to take advantage of the growing Chinese clean energy market. *Beijing:* With a population of over 15 million, Beijing is China's largest city. Its Gross Domestic Product
(GDP)was $84 billion in 2005, an increase of 11.1% from the previous year. As the national capital, Beijing offers unparalleled access to Chinese policymakers. Since China's energy sector is regulated by the central government, interaction with these officials can be critical to a companies' success. There is also a strong local market for clean energy technologies in Beijing, due to its size, its political and economic importance, and the poor environmental conditions caused by development. Beijing is unique in China in that it has provincial status, which enables its municipal government to approve independent foreign investment projects up to a value of $30 million. This has positioned Beijing as an attractive location for foreign investment in China. The selection of the city as host of the 2008 Summer Olympic Games has spurred substantial government investment in projects that improve environmental quality. To facilitate trade and investment in clean energy technologies and help create commercial opportunities for mission participants, ITA is working with the Chinese Government to hold the first U.S.-China Clean Energy Technologies Industry Forum (CETIF). The creation of a U.S.-China CETIF would establish an annual forum designed to establish dialogue between U.S. and Chinese industry and appropriate government representatives on a variety of energy and environmental trade, technology, and policy issues. This event is expected to take place on Wednesday, January 9, 2008, and is open to all mission participants. *Guangzhou:* Guangzhou is the economic center of the Pearl River Delta and is the heart of one of China's leading commercial and manufacturing regions. With an estimated population of 12 million, Guangzhou is the third most populous metropolitan area in China. Its proximity to Hong Kong has provided the region with an influx of investment and fostered a Western business culture that has made Guangdong province one of the most developed provinces in the Pearl River Delta. In 2005, Guangdong's GDP rose to $278.9 billion, ranking first in the country and accounting for about 10 percent of the national GDP. By the end of 2006, Guangdong had received $177.37 billion in total stock of foreign direct investment (FDI), representing one fourth of the national total, and accounted for 40 percent of all international trade between China and other countries. The Pearl River Delta has experienced serious environmental problems due to its rapid industrialization and heavy manufacturing base. The Guangdong Government has budgeted 3 percent of its GDP for overall environmental spending during the Eleventh Five-Year Plan, more than $8 billion. Strong commercial prospects for Guangdong include energy efficiency and cleaner production technologies, combined heat and power, wind energy, solar energy, hydropower, biogas, and waste-to-energy. The Guangdong Government plans to spend $726 million between 2005 and 2010 and $1.93 billion between 2010 and 2020 on wind power projects, and China's renewable energy law contains incentives to make wind power more cost competitive with coal-fired generation. The city of Guangzhou plans to treat 90 percent of its solid waste using waste-to-energy plants. *Hong Kong:* Hong Kong is affected by pollution from the mainland and particularly from Guangdong Province and the Pearl River Delta. The Pollution Prevention and Energy Efficiency
(P2E2)environmental financing program is designed to address this issue and to develop business opportunities for U.S. companies. Through financial support from the Asian Development Bank, International Finance Corporation, and U.S. Export-Import Bank, the P2E2 program encourages Hong Kong-based Environment and Energy Service Companies (EESCOs) to develop pollution prevention and energy efficiency projects throughout mainland China and other developing Asian countries. These projects focus on correcting production and energy consumption inefficiencies in existing manufacturing plants and other facilities, thereby creating cost savings while addressing the region's growing pollution problem. The technology upgrades required to complete these projects provide significant opportunities for American technology vendors. India India is experiencing dramatic economic growth and a rapidly increasing demand for energy. Currently the world's sixth-largest energy consumer, India will be the third largest by 2030. Both India's cities and villages lack adequate energy supply, so there is need to add on-grid and off-grid power generation. The Government of India has specified renewable energy in its development plans and has developed numerous government incentives. The federal government has set a goal of electrifying 18,000 remote villages and meeting 10 percent of its energy demand with clean energy by 2012. The Indian market for clean energy is estimated at $600 million with an annual growth rate of 25 percent. The current 8,000 MW of installed capacity is expected to reach 20,000 MW by 2012. The clean energy market in India offers strong business prospects to U.S. companies, particularly in solar, biomass, gasification, wind, hydro, and solid and industrial waste-to-energy. The market for energy efficiency is estimated to be about $2 billion, concentrated especially in energy-intensive industries such as cement, aluminum, fertilizers, pulp and paper, petrochemicals, and steel. *Kolkata:* With a metropolitan population of 13 million, Kolkata (formerly Calcutta) is the capital of the state of West Bengal. Kolkata is the main commercial and financial hub of eastern India, which is home to a population of 280 million people living in 12 states and contributing 22 percent of India's annual net domestic product. The Communist party-led state government has in recent years adopted more investor-friendly policies, which has led to regional growth, consistently among the highest in all of India. Over 100 U.S. firms have a presence in Kolkata in sectors such as IT, mining, chemicals and petrochemicals, food processing, financial services, consumer goods, and engineering. Significant opportunities are emerging in infrastructure development projects, including power generation. West Bengal is implementing one of the largest clean energy programs in India, covering a broad spectrum of energy technologies such as solar thermal, solar photovoltaic, wind turbines, micro-turbines, biogas plants, biomass gasifiers, small hydro and tidal power. The total current generation from renewable sources is about 62 MW, and another 100 MW in renewable power capacity is being added through $183 million in private investment in the next two years. Much more private investment is being sought to meet the State's rapidly growing energy demands. *Bangalore:* With a population of 7 million, Bangalore is the capital of the State of Karnataka and is “the Silicon Valley of India.” Also known as the Knowledge Capital and Biotechnology Capital, the city is India's high-profile Information Technology
(IT)center. In addition to its thriving IT and biotech sectors, Bangalore is the hub of India's aerospace, electronics, machine tools, automation and food processing industries. These growing industrial and commercial entities need access to reliable energy and the State of Karnataka is known for its clean energy initiatives. The state agency in this sector, the Karnataka Renewable Energy Development Ltd. (KREDL), is widely known as one of the most progressive in India and has many programs to promote clean energy. Karnataka currently has 1,600 MW of installed renewable energy capacity. This is expected to reach 2,500 MW by 2012. The wind sector is witnessing very high growth rates, and the State has plans to increase installed wind capacity (especially in and around the Chitradurga area of the State) at the rate of 200 MW per year. Biomass cogeneration, solar, and small hydro are also areas of high growth. *Mission Goals:* The Trade Mission will facilitate market entry or increased sales into these significant markets for U.S. clean energy technologies and services firms, and to assist mission participants in gaining first-hand market information and access to key government officials and potential business partners. *Mission Scenario:* In China and India, the International Trade Administration will: • Provide a market briefing highlighting opportunities in the clean energy technologies sectors. • Schedule one-on-one appointments with potential business partners for each participant. • Provide a venue for the one-on-one appointments and provide interpreters as needed. • Provide networking opportunities with the private and public sectors. • Organize relevant site visits. *Proposed Mission Timetable:* Tuesday, January 8, 2008. Arrive in Beijing, Embassy Briefing, Welcome Reception. Wednesday, January 9, 2008. U.S.-China Clean Energy Technologies Industry Forum, One-on-One Business Meetings, Networking Reception. Thursday, January 10, 2008. Meeting with China's National Development and Reform Commission, Site Visit, One-on-One Business Meetings (Optional), Depart Beijing, Arrive Guangzhou. Friday, January 11, 2008. Consulate Briefing, Local Government Meetings, One-on-One Business Meetings, Depart Guangzhou, Arrive Hong Kong. Saturday, January 12, 2008. Clean Energy Finance Seminars and Networking Events in Hong Kong. Sunday, January 13, 2008. Depart Hong Kong, Arrive Kolkata. Monday, January 14, 2008. Consulate Briefing, Local Clean Energy Market Briefing, One-on-One Business Meetings, Networking Reception. Tuesday, January 15, 2008. Depart Kolkata, Arrive Bangalore, Local Clean Energy Market Briefing, Consulate Briefing, Dinner or Reception. Wednesday, January 17, 2008. Government/Business Meetings, One-on-One Business Meetings, Dinner or Reception. Thursday, January 18, 2008. Depart Bangalore. (It is possible for companies to participate in one or both countries of this trade mission.) Criteria for Participation: • Relevance of the company's business line to the mission scope and goals; • Potential for business in the selected markets; • Timeliness of the company's completed application, participation agreement, and payment of the mission participation fee; • Provision of adequate information on the company's products and/or services and communication of the company's primary objectives to facilitate appropriate matching with potential business partners; • Certification that the company's products and/or services are manufactured or produced in the United States or, if manufactured/produced outside of the United States, the products/services must be marketed under the name of a U.S. firm and have U.S. content representing at least 51 percent of the value of the finished goods or services; and • Diversity of sectors represented. Any partisan political activities of an applicant, including political contributions, will be entirely irrelevant to the selection process. The mission will be promoted through the following venues: ITA's Export Assistance Centers, the Energy Team, the Asia Pacific Team, the Africa, Near East, and South Asia Team, Global Trade Programs; the Trade Events List *http://www.export.gov;* industry newsletters; the **Federal Register** ; the Asia-Pacific Partnership for Clean Development and Climate; relevant trade publications; relevant trade associations; past Commerce trade mission participants; various in-house and purchased industry lists; the Commerce Department trade missions calendar: *http://www.ita.doc.gov/doctm/tmcal.html;* and the Web: *http://www.export.gov/cleanenergymission.* Recruitment will begin immediately and will close on November 5, 2007. Qualified U.S companies/applicants will be selected on a rolling basis. The trade mission participation fee will be U.S.$3,500 per company. (If a company would like to participate in just the China or India portion of the trade mission, the participation fee will be $1,750) There will be an additional fee of $750 per country for each additional participant a company sends. The participation fee does not include the cost of travel, lodging, some ground transportation, or some meals. Participation is open to 25 qualified U.S. companies. Invited companies must submit the trade mission participation fee and completed participation agreement within two weeks of receipt of their invitation in order to secure their place in the mission. After that time other companies may be invited to fill that spot. Applications received after the closing date will be considered only if space and scheduling constraints permit. Dated: September 12, 2007. Stephen Jacobs, Deputy Assistant Secretary of Commerce for Market Access & Compliance. [FR Doc. 07-4681 Filed 9-21-07; 8:45 am]
Connectionstraces to 31
Traces to 31 documents
U.S. Code
- Rule making§ 553
- SHORT TITLE.§ 801
- Commission§ 155
- Interest and penalty on claims§ 3717
- Transition to sustainable fisheries§ 1861a
- Purpose§ 561
- Findings, purposes and policy§ 1801
- New drugs§ 355
- Schedules of controlled substances§ 812
- Authority and criteria for classification of substances§ 811
- Extension of patent term§ 156
- Hearings; presiding employees; powers and duties; burden of proof; evidence; record as basis of decision§ 556
- Attorney General§ 871
- Civil proceedings§ 9613
- Public participation§ 9617
- Regulatory agenda§ 602
- Purposes§ 3501
register
CFR
- Schedule III.§ 1308.13
- Definitions.§ 320.1
- General functions.§ 0.100
- Initiation of proceedings for rulemaking.§ 1308.43
- Request for hearing or appearance; waiver.§ 1308.44
- Proposal and application requirements and procedures.§ 251.54
- Cost recovery.§ 251.58
- Administrative review of orders and suspension agreements under section 751(a)(1) of the Act.§ 351.213
- Assessment of antidumping and countervailing duties; provisional measures deposit cap; interest on certain overpayments and underpayments.§ 351.212
19 references not yet in our index
- 33 CFR 165
- 47 CFR 54
- 48 Stat. 1068
- 50 CFR 600
- 46 USC 1279f
- Pub. L. 108-447
- 50 CFR 622
- 21 CFR 610
- 21 CFR 1308
- 21 CFR 1308.11-1308
- 290 F.3d 430
- 5 USC 601-612
- 40 CFR 300
- 40 CFR 300.425(e)(l)(i)
- 40 CFR 300.425(e)
- 40 CFR 300.425(e)(1)(i)
- 36 CFR 251
- 2 USC 1531-1538
- 5 CFR 1320
Citation graph
cites case law
Notices
Temporary final rule; additional correction
F. App'x290 F.3d 430
Cite33 CFR 165
Cite47 CFR 54
Cites 50 · showing 12Cited by 0 across 0 sources