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Code · REGISTER · 2007-04-20 · Food and Drug Administration, HHS · Rules and Regulations

Rules and Regulations. Final rule

21,276 words·~97 min read·/register/2007/04/20/07-1922

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 4910-13-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Clindamycin Solution AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration
(FDA)is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by First Priority, Inc. The ANADA provides for the veterinary prescription use of clindamycin hydrochloride oral solution in dogs and cats for the treatment of various infections due to susceptible bacterial pathogens. DATES: This rule is effective April 20, 2007. FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: *john.harshman@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: First Priority, Inc., 1585 Todd Farm Dr., Elgin, IL 60123, filed ANADA 200-398 for the veterinary prescription use of Clindamycin Hydrochloride Oral Drops in dogs and cats for the treatment of various infections due to susceptible bacterial pathogens. First Priority, Inc.'s Clindamycin Hydrochloride Oral Drops is approved as a generic copy of ANTIROBE AQUADROPS Liquid, sponsored by Pharmacia & Upjohn Co., a Division of Pfizer, Inc., under NADA 135-940. The ANADA is approved as of March 19, 2007, and 21 CFR 520.447 is amended to reflect the approval. In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. FDA has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. List of Subjects in 21 CFR Part 520 Animal drugs. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is amended as follows: PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 520 continues to read as follows: Authority: 21 U.S.C. 360b. 2. In § 520.447 revise paragraph
(b)to read as follows: § 520.447 Clindamycin Solution.
(b)*Sponsors* . See Nos. 000009, 051311, 058829, and 059130 in § 510.600(c) of this chapter. Dated: April 9, 2007. Bernadette Dunham, Deputy Director, Center for Veterinary Medicine. [FR Doc. E7-7472 Filed 4-19-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Oral Dosage Form New Animal Drugs; Dexmedetomidine; Technical Amendment AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. SUMMARY: The Food and Drug Administration
(FDA)is amending a final rule that appeared in the **Federal Register** of January 4, 2007 (72 FR 263), revising the animal drug regulations to reflect approval of an original new animal drug application (NADA). The document incorrectly listed the amount of drug per milliliter of dexmedetomidine hydrochloride injectable solution. This action is being taken to improve the accuracy of the regulations. DATES: This rule is effective April 20, 2007. FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-267-9019, e-mail: *george.haibel@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: FDA has discovered that an error has been incorporated into the agency's regulations for 21 CFR part 522. This document corrects that error. Publication of this document constitutes final action under the Administrative Procedure Act (5 U.S.C. 553). FDA has determined that notice and public comment are unnecessary because this amendment is nonsubstantive. List of Subjects in 21 CFR Part 522 Animal drugs. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 522 is amended as follows: PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 522 continues to read as follows: Authority: 21 U.S.C. 360b. 2. In § 522.558, paragraph
(a)is revised to read as follows: § 522.558 Dexmedetomidine.
(a)*Specifications.* Each milliliter of solution contains 0.5 milligram
(mg)of dexmedetomidine hydrochloride. Dated: April 13, 2007. Bernadette Dunham, Deputy Director, Center for Veterinary Medicine. [FR Doc. E7-7594 Filed 4-19-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 556 and 558 New Animal Drugs; Florfenicol AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration
(FDA)is amending the animal drug regulations to reflect the approval of a supplemental new animal drug application
(NADA)filed by Schering-Plough Animal Health Corp. The supplemental NADA provides for the use of florfenicol by veterinary feed directive
(VFD)for the control of mortality in freshwater-reared salmonids due to coldwater disease associated with *Flavobacterium psychrophilum* . DATES: This rule is effective April 20, 2007. FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: *joan.gotthardt@fda.gov* . SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 556 Morris Ave., Summit, NJ 07901, filed a supplement to NADA 141-246 that provides for use of AQUAFLOR (florfenicol), a type A medicated article, by VFD to formulate type C medicated feed for the control of mortality in freshwater-reared salmonids due to coldwater disease associated with *F. psychrophilum* . The supplemental application is approved as of March 19, 2007, and the regulations are amended in 21 CFR 556.283, 558.4, and 558.261 to reflect the approval. The single VFD order form for florfenicol includes both catfish and freshwater-reared salmonid indications because each comprises multiple species and is approved in each for use under similar directions and conditions of use. In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Under section 573(c) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360ccc-2), this supplemental approval qualifies for 7 years of exclusive marketing rights beginning March 19, 2007, because the new animal drug has been declared a designated new animal drug by FDA under section 573(a) of the act. The agency has carefully considered the potential environmental impact of this action and has concluded that the action will not have a significant impact on the human environment and that an environmental impact statement is not required. FDA's finding of no significant impact and the evidence supporting that finding, contained in an environmental assessment, may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. List of Subjects 21 CFR Part 556 Animal drugs, Foods. 21 CFR Part 558 Animal drugs, Animal feeds. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 556 and 558 are amended as follows: PART 556—TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD 1. The authority citation for 21 CFR part 556 continues to read as follows: Authority: 21 U.S.C. 342, 360b, 371. 2. In § 556.283, add paragraph (b)(4) to read as follows: § 556.283 Florfenicol.
(b)* * *
(4)*Salmonids* . The tolerance for florfenicol amine (the marker residue) in muscle/skin (the target tissues) is 1 ppm. PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 3. The authority citation for 21 CFR part 558 continues to read as follows: Authority: 21 U.S.C. 360b, 371. 4. In paragraph
(d)of § 558.4, in the “Category II” table, revise the entry in alphabetical order for “Florfenicol” to read as follows: § 558.4 Requirement of a medicated feed mill license.
(d)* * * **Category II** Drug Assay limits percent 1 Type A Type B maximum
(100x)Assay limits percent 1 Type B/C 2 * * * * * * * Florfenicol 90-110 Swine feed: n/a Swine feed: 85-115 Catfish feed: n/a Catfish feed: 80-110 Salmonid feed: n/a Salmonid feed: 80-110 * * * * * * * 1 Percent of labeled amount. 2 Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two range limits, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed. These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B medicated feed with lower assay limits to make a Type C medicated feed. 5. In § 558.261, revise paragraph (a)(2), paragraph (c)(2)(i), and the first two sentences of paragraph (e)(2)(iii); and add new paragraph (e)(3) to read as follows: § 558.261 Florfenicol.
(a)* * *
(2)500 grams per kilogram for use as in paragraphs (e)(2) and (e)(3) of this section.
(c)* * *
(2)* * *
(i)For catfish and freshwater-reared salmonids, must not exceed 15 days from the date of issuance;
(e)* * *
(2)* * *
(iii)* * * Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. * * *
(3)*Freshwater-reared salmonids* —(i) *Amount* . 10 milligrams florfenicol per kilogram of fish daily for 10 consecutive days.
(ii)*Indications for use* . For the control of mortality due to coldwater disease associated with *Flavobacterium psychrophilum* .
(iii)*Limitations* . Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. The effects of florfenicol on reproductive performance have not been determined. Feeds containing florfenicol must be withdrawn 15 days prior to slaughter. Dated: April 9, 2007. Bernadette Dunham, Deputy Director, Center for Veterinary Medicine. [FR Doc. E7-7475 Filed 4-19-07; 8:45 am] BILLING CODE 4160-01-S BROADCASTING BOARD OF GOVERNORS 22 CFR Part 504 Testimony by BBG Employees, Production of Official Records, and Disclosure of Official Information In Legal Proceedings AGENCY: Broadcasting Board of Governors. ACTION: Final rule. SUMMARY: The Broadcasting Board of Governors
(BBG)is publishing as a final rule a regulation governing access to BBG information and records in connection with legal proceedings in which neither the United States nor the BBG is a party. The proposed rule was published for comment in 72 FR 10954 dated March 12, 2007. The BBG received no responses to the proposed rule. The final rule and corresponding regulation establishes guidelines for use in determining whether BBG employees are permitted to testify or to provide records relating to their official duties and procedures that requesters must follow when making demands on, or requests to, a BBG employee for official documents or to provide testimony. DATES: The effective date of the regulation is April 23, 2007. FOR FURTHER INFORMATION CONTACT: Christopher Veith, Assistant General Counsel, Broadcasting Board of Governors, 330 Independence Ave., SW., Washington, DC 20237, phone:
(202)203-4550 or fax at
(202)203-4585. SUPPLEMENTARY INFORMATION: Briefly, the final rule prohibits disclosure of nonpublic official records or testimony by the BBG's employees, as defined in Part 504.4, unless there is compliance with the rule. The final rule sets out the information that requesters must provide and the factors that the BBG will consider in making determinations in response to requests for testimony or the production of documents. The final rule applies to a range of matters in any legal proceeding in which the BBG is not a named party and applies to current and former BBG employees. The final rule will ensure a more efficient use of the BBG's resources, minimize the possibility of involving the BBG in issues unrelated to its responsibilities, promote uniformity in responding to subpoenas and like requests, and maintain the impartiality of the BBG in matters that are in dispute between other parties. It will also serve the BBG's interest in protecting sensitive, confidential, and privileged information and records that are generated in fulfillment of the BBG's statutory responsibilities. The final rule is internal and procedural rather than substantive. It does not create a right to obtain official records or the official testimony of a BBG employee nor does it create any additional right or privilege not already available to the BBG to deny any demand or request for testimony or documents. Failure to comply with the procedures set out in these regulations would be a basis for denying a demand or request submitted to the BBG. List of Subjects in 22 CFR Part 504 Administrative practice and procedure. For the reasons stated in the preamble, the Broadcasting Board of Governors amends 22 CFR, Chapter V, by adding part 504, as follows: PART 504—TESTIMONY BY BBG EMPLOYEES, PRODUCTION OF OFFICIAL RECORDS, AND DISCLOSURE OF OFFICIAL INFORMATION IN LEGAL PROCEEDINGS Subpart A—General Provisions Sec. 504.1 Scope and purpose. 504.2 Applicability. 504.3 Definitions. Subpart B—Demands or Requests for Testimony and Production of Documents 504.4 General prohibition. 504.5 Factors the BBG will consider. 504.6 Filing requirements for litigants seeking documents or testimony. 504.7 Service of requests or demands. 504.8 Processing requests or demands. 504.9 Final determinations. 504.10 Restrictions that apply to testimony. 504.11 Restrictions that apply to released records. 504.12 Procedure when a decision is not made prior to the time a response is required. 504.13 Procedure in the event of an adverse ruling. Subpart C—Schedule of Fees 504.14 Fees. Subpart D—Penalties 504.15 Penalties Authority: 22 U.S.C. 6204. Subpart A—General Provisions § 504.1 Scope and purpose.
(a)These regulations in this subpart establish policy, assign responsibilities and prescribe procedures with respect to:
(1)The production or disclosure of official information or records by BBG employees, and
(2)The testimony of current and former BBG employees, relating to official information, official duties, or the BBG's records, in connection with federal or state litigation in which the BBG is not a party.
(b)The BBG intends these provisions to:
(1)Conserve the time of BBG employees for conducting official business;
(2)Minimize the involvement of BBG employees in issues unrelated to BBG's mission;
(3)Maintain the impartiality of BBG employees in disputes between private litigants; and
(4)Protect sensitive, confidential information and the deliberative processes of the BBG.
(c)In providing for these requirements, the BBG does not waive the sovereign immunity of the United States.
(d)This part provides guidance for the internal operations of BBG. It does not create any right or benefit, substantive or procedural, that a party may rely upon in any legal proceeding against the United States. § 504.2 Applicability. This part applies to demands and requests to current and former employees for factual or expert testimony relating to official information or official duties or for production of official records or information, in legal proceedings in which the BBG is not a named party. This part does not apply to:
(a)Demands upon or requests for a BBG employee to testify as to facts or events that are unrelated to his or her official duties or that are unrelated to the functions of the BBG;
(b)Demands upon or requests for a former BBG employee to testify as to matters in which the former employee was not directly or materially involved while at the BBG;
(c)Requests for the release of records under the Freedom of Information Act, 5 U.S.C. 552, or the Privacy Act, 5 U.S.C. 552a; or
(d)Congressional demands and requests for testimony, records or information. § 504. 3 Definitions. The following definitions apply to this part:
(a)Demand means an order, subpoena, or other command of a court or other competent authority for the production, disclosure, or release of records or for the appearance and testimony of a BBG employee in a legal proceeding.
(b)General Counsel means the General Counsel of the BBG or a person to whom the General Counsel has delegated authority under this part.
(c)Legal proceeding means any matter before a court of law, administrative board or tribunal, commission, administrative law judge, hearing officer or other body that conducts a legal or administrative proceeding. Legal proceeding includes all phases of litigation.
(d)BBG means the Broadcasting Board of Governors.
(e)BBG employee means:
(1)Any current or former employee of the BBG.
(2)This definition does not include persons who are no longer employed by the BBG and who agree to testify about general matters, matters available to the public, or matters with which they had no specific involvement or responsibility during their employment with the BBG.
(f)Records or official records and information means all information in the custody and control of the BBG, relating to information in the custody and control of the BBG, or acquired by a BBG employee in the performance of his or her official duties or because of his or her official status, while the individual was employed by the BBG.
(g)Request means any informal request, by whatever method, for the production of records and information or for testimony which has not been ordered by a court or other competent authority.
(h)Testimony means any written or oral statements, including depositions, answers to interrogatories, affidavits, declarations, interviews, and statements made by an individual in connection with a legal proceeding. Subpart B—Demands or Requests for Testimony and Production of Documents § 504.4 General prohibition.
(a)In any United States federal, state, and local proceeding or administrative action, or proceeding or administrative action conducted in a foreign country, in which the BBG is not a party, no BBG employee shall, in response to a demand or request for official records or information, furnish or produce documents or testimony as to any material contained in BBG files, any information relating to or based upon material contained in BBG files, or any information or material acquired as part of the performance of that person's official duties (or because of that person's official status) without the prior written approval of the General Counsel.
(b)Whenever a request or demand for information is made upon a BBG employee, the employee, wherever located, shall immediately prepare a report that specifically describes the testimony or documents sought and immediately notify the General Counsel. The BBG employee shall then await instructions from the General Counsel concerning a response to the request or demand. The failure of any BBG employee to follow the procedures specified in this subpart neither creates nor confers any rights, privileges, or benefits on any person or party. § 504.5 Factors the BBG will consider. The General Counsel, in his or her sole discretion, may grant an employee permission to testify on matters relating to official information, or produce official records and information, in response to a demand or request. Among the relevant factors that the General Counsel may consider in making this decision are whether:
(a)The purposes of this part are met;
(b)Allowing such testimony or production of records would be necessary to prevent a miscarriage of justice;
(c)Allowing such testimony or production of records would assist or hinder the BBG in performing its statutory duties;
(d)Allowing such testimony or production of records would be in the best interest of the BBG or the United States;
(e)The records or testimony can be obtained from other sources;
(f)The demand or request is unduly burdensome or otherwise inappropriate under the applicable rules of discovery or the rules of procedure governing the case or matter in which the demand or request arose;
(g)Disclosure would violate a statute, Executive Order or regulation;
(h)Disclosure would reveal confidential, sensitive, or privileged information, trade secrets or similar, confidential or financial information, otherwise protected information, or information which would otherwise be inappropriate for release;
(i)Disclosure would impede or interfere with an ongoing law enforcement investigation or proceeding, or compromise constitutional rights or national security interests;
(j)Disclosure would result in the BBG appearing to favor one litigant over another;
(k)The request was served before the demand;
(l)A substantial Government interest is implicated;
(m)The demand or request is within the authority of the party making it; and
(n)The demand or request is sufficiently specific to be answered and/or can be limited to information to that which would be consistent with the factors specified herein. § 504.6 Filing requirements for litigants seeking documents or testimony. A litigant must comply with the following requirements when filing a request for official records and information or testimony under this subpart. A request should be filed before a demand.
(a)The request must be in writing and must be submitted to the General Counsel.
(b)The written request must contain the following information:
(1)The caption of the legal proceeding, docket number, and name and address of the court or other authority involved;
(2)A copy of the complaint or equivalent document setting forth the assertions in the case and any other pleading or document necessary to show relevance;
(3)A list of categories of records sought, a detailed description of how the information sought is relevant to the issues in the legal proceeding, and a specific description of the substance of the testimony or records sought;
(4)A statement as to how the need for the information outweighs any need to maintain the confidentiality of the information and outweighs the burden on the BBG to produce the records or provide testimony;
(5)A statement indicating that the information sought is not available from another source, from other persons or entities, or from the testimony of someone other than an BBG employee, such as a retained expert;
(6)If testimony is requested, the intended use of the testimony, and a showing that no document could be provided and used in lieu of testimony;
(7)A description of all prior decisions, orders, or pending motions in the case that bear upon the relevance of the requested records or testimony;
(8)The name, address, and telephone number of counsel to each party in the case; and
(9)An estimate of the amount of time that the requester and other parties will require for each BBG employee for time spent by the employee to prepare for testimony, in travel, and for attendance in the legal proceeding.
(c)The BBG reserves the right to require additional information to complete the request where appropriate.
(d)The request should be submitted at least 30 days before the date that records or testimony is required. Requests submitted in less than 30 days before records or testimony is required must be accompanied by a written explanation stating the reasons for the late request and the reasons for expedited processing.
(e)Failure to cooperate in good faith to enable the General Counsel to make an informed decision may serve as the basis for a determination not to comply with the request.
(f)The request should state that the requester will provide a copy of the BBG employee's statement free of charge and that the requester will permit the BBG to have a representative present during the employee's testimony. § 504.7 Service of requests or demands. Requests or demands for official records or information or testimony under this Subpart must be served on the General Counsel, BBG, 330 Independence Ave., SW., Washington, DC 20237 by mail or fax at
(202)203-4585 and clearly marked “Part 504—Request for Testimony or Official Records in Legal Proceedings.” § 504.8 Processing requests or demands.
(a)After receiving service of a request or demand for testimony, the General Counsel will review the request and, in accordance with the provisions of this Subpart, determine whether, or under what conditions, to authorize the employee to testify on matters relating to official information and/or produce official records and information.
(b)Absent exigent circumstances, the BBG will issue a determination within 30 days from the date the request is received.
(c)The General Counsel may grant a waiver of any procedure described by this Subpart where a waiver is considered necessary to promote a significant interest of the BBG or the United States, or for other good cause.
(d)Certification (authentication) of copies of records. The BBG may certify that records are true copies in order to facilitate their use as evidence. If a requester seeks certification, the requester must request certified copies from the BBG at least 30 days before the date they will be needed. The request should be sent to the BBG General Counsel. § 504.9 Final determinations. The General Counsel makes the final determination on demands or requests to employees for production of official records and information or testimony in litigation in which the BBG is not a party. All final determinations are within the sole discretion of the General Counsel. The General Counsel will notify the requester and, when appropriate, the court or other competent authority of the final determination, the reasons for the grant or denial of the request, and any conditions that the General Counsel may impose on the release of records or information, or on the testimony of an BBG employee. The General Counsel's decision exhausts administrative remedies for discovery of the information. § 504.10 Restrictions that apply to testimony.
(a)The General Counsel may impose conditions or restrictions on the testimony of BBG employees including, for example:
(1)Limiting the areas of testimony;
(2)Requiring the requester and other parties to the legal proceeding to agree that the transcript of the testimony will be kept under seal;
(3)Requiring that the transcript will be used or made available only in the particular legal proceeding for which testimony was requested. The General Counsel may also require a copy of the transcript of testimony at the requester's expense.
(b)The BBG may offer the employee's written declaration in lieu of testimony.
(c)If authorized to testify pursuant to this part, an employee may testify as to facts within his or her personal knowledge, but, unless specifically authorized to do so by the General Counsel, the employee shall not:
(1)Disclose confidential or privileged information; or
(2)For a current BBG employee, testify as an expert or opinion witness with regard to any matter arising out of the employee's official duties or the functions of the BBG unless testimony is being given on behalf of the United States (see also 5 CFR 2635.805).
(d)The scheduling of an employee's testimony, including the amount of time that the employee will be made available for testimony, will be subject to the BBG's approval. § 504.11 Restrictions that apply to released records.
(a)The General Counsel may impose conditions or restrictions on the release of official records and information, including the requirement that parties to the proceeding obtain a protective order or execute a confidentiality agreement to limit access and any further disclosure. The terms of the protective order or of a confidentiality agreement must be acceptable to the General Counsel. In cases where protective orders or confidentiality agreements have already been executed, the BBG may condition the release of official records and information on an amendment to the existing protective order or confidentiality agreement.
(b)If the General Counsel so determines, original BBG records may be presented for examination in response to a request, but they may not be presented as evidence or otherwise used in a manner by which they could lose their identity as official BBG records, nor may they be marked or altered. In lieu of the original records, certified copies may be presented for evidentiary purposes. § 504.12 Procedure when a decision is not made prior to the time a response is required. If a response to a demand or request is required before the General Counsel can make the determination referred to in § 504.9, the General Counsel, when necessary, will provide the court or other competent authority with a copy of this part, inform the court or other competent authority that the request is being reviewed, provide an estimate as to when a decision will be made, and seek a stay of the demand or request pending a final determination. § 504.13 Procedure in the event of an adverse ruling. If the court or other competent authority fails to stay a demand or request, the employee upon whom the demand or request is made, unless otherwise advised by the General Counsel, will appear, if necessary, at the stated time and place, produce a copy of this part, state that the employee has been advised by counsel not to provide the requested testimony or produce documents, and respectfully decline to comply with the demand or request, citing *United States ex rel. Touhy* v. *Ragen,* 340 U.S. 462 (1951). Subpart C—Schedule of Fees § 504.14 Fees.
(a)*Generally.* The General Counsel may condition the production of records or appearance for testimony upon advance payment of a reasonable estimate of the costs to the BBG.
(b)*Fees for records.* Fees for producing records will include fees for searching, reviewing, and duplicating records, costs of attorney time spent in reviewing the request, and expenses generated by materials and equipment used to search for, produce, and copy the responsive information. Costs for employee time will be calculated on the basis of the hourly pay of the employee (including all pay, allowances, and benefits). Fees for duplication will be the same as those charged by the BBG in its Freedom of Information Act regulations at 22 CFR Part 503.
(c)*Witness fees.* Fees for attendance by a witness will include fees, expenses, and allowances prescribed by the court's rules. If no such fees are prescribed, witness fees will be determined based upon the rule of the Federal district court closest to the location where the witness will appear and on 28 U.S.C. 1821, as applicable. Such fees will include cost of time spent by the witness to prepare for testimony, in travel and for attendance in the legal proceeding, plus travel costs.
(d)*Payment of fees.* A requester must pay witness fees for current BBG employees and any record certification fees by submitting to the General Counsel a check or money order for the appropriate amount made payable to the Treasury of the United States. In the case of testimony of former BBG employees, the requester must pay applicable fees directly to the former BBG employee in accordance with 28 U.S.C. 1821 or other applicable statutes.
(e)*Waiver or reduction of fees.* The General Counsel, in his or her sole discretion, may, upon a showing of reasonable cause, waive or reduce any fees in connection with the testimony, production, or certification of records.
(f)*De minimis fees.* Fees will not be assessed if the total charge would be $10.00 or less. Subpart D—Penalties § 504.15 Penalties.
(a)An employee who discloses official records or information or gives testimony relating to official information, except as expressly authorized by the BBG, or as ordered by a Federal court after the BBG has had the opportunity to be heard, may face penalties as provided in any applicable enforcement statute.
(b)A current BBG employee who testifies or produces official records and information in violation of this part shall be subject to disciplinary action and, if done for a valuable consideration, may subject that person to criminal prosecution. Dated: April 16, 2007. Carol F. Baker, Director, Office of Administration. [FR Doc. E7-7559 Filed 4-19-07; 8:45 am] BILLING CODE 8610-01-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R09-OAR-2007-0197; FRL-8300-5] Approval and Promulgation of Implementation Plans; Revisions to the Nevada State Implementation Plan; Definition, Emergency Episode, and Monitoring Regulations AGENCY: Environmental Protection Agency (EPA). ACTION: Direct final rule. SUMMARY: EPA is taking direct final action to approve revisions to the Nevada Department of Conservation and Natural Resources portion of the Nevada State Implementation Plan (SIP). These revisions concern a definition, an emergency episode regulation, and various monitoring regulations. We are approving state provisions that regulate emission sources under the Clean Air Act as amended in 1990 (Act or CAA). DATES: This rule is effective on June 19, 2007 without further notice, unless EPA receives adverse comments by May 21, 2007. If we receive such comments, we will publish a timely withdrawal in the **Federal Register** to notify the public that this direct final rule will not take effect. ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-2007-0197, by one of the following methods: 1. *Federal eRulemaking Portal:* *http://www.regulations.gov.* Follow the on-line instructions. 2. *E-mail:* *steckel.andrew@epa.gov.* 3. *Mail or deliver:* Andrew Steckel (Air-4), U.S. Environmental Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA 94105-3901. *Instructions:* All comments 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 Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Information that you consider CBI or otherwise protected should be clearly identified as such and should not be submitted through *http://www.regulations.gov* or e-mail. *http://www.regulations.gov* is an “anonymous access” system, and EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send e-mail directly to EPA, your e-mail address will be automatically captured and included as part of the public comment. 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. *Docket:* The index to the docket for this action is available electronically at *http://www.regulations.gov* and in hard copy at EPA Region IX, 75 Hawthorne Street, San Francisco, California. While all documents in the docket are listed in the index, some information may be publicly available only at the hard copy location (e.g., copyrighted material), and some may not be publicly available in either location (e.g., CBI). To inspect the hard copy materials, please schedule an appointment during normal business hours with the contact listed in the FOR FURTHER INFORMATION CONTACT section. FOR FURTHER INFORMATION CONTACT: Julie A. Rose, EPA Region IX,
(415)947-4126. SUPPLEMENTARY INFORMATION: Throughout this document, “we,” “us” and “our” refer to EPA. Table of Contents I. The State's Submittal A. What Regulations Did the State Submit? B. What Is the Regulatory History of the Nevada SIP? C. What Is the Purpose of This Rulemaking? II. EPA's Evaluation and Action A. How Is EPA Evaluating the Regulations? B. Do the Regulations Meet the Evaluation Criteria? C. Public Comment and Final Action III. Statutory and Executive Order Reviews I. The State's Submittal A. What Regulations Did the State Submit? The Governor's designee, the Nevada Department of Conservation and Natural Resources, Division of Environmental Protection (NDEP), submitted a revision to the applicable state implementation plan
(SIP)on December 8, 2006. Most of the provisions submitted on December 8, 2006 concern permitting regulations which are the subject of a separate **Federal Register** proposed rule. The remaining regulations are being acted on in this rulemaking and concern clarifications made to harmonize State and Federally-enforceable requirements. The following table lists the provisions of the Nevada Administrative Code
(NAC)addressed by this rulemaking with the dates they were submitted by NDEP. Submitted Provisions NAC No. NAC title Adopted Submitted 445B.134 “Person” defined 09/06/06 12/08/06 445B.230 Plan for reduction of emissions 09/06/06 12/08/06 445B.258 Monitoring systems: Verification of operational status 09/06/06 12/08/06 445B.259 Monitoring systems: Performance evaluations 09/06/06 12/08/06 445B.260 Monitoring systems: Components contracted for before September 11, 1974 09/06/06 12/08/06 The Nevada SIP includes previous versions of these regulations. We approved NAC 445B.134, 445B.258, 445B.259, and 445B.260 on December 11, 2006 (71 FR 71486) and approved NAC 445B.230 on March 27, 2006 (71 FR 15040). The amended regulations submitted by NDEP on December 8, 2006 were included as sections 2, 5, 6, 7, and 8 of Regulation R151-06, which was adopted by the State Environmental Commission on September 6, 2006. B. What Is the Regulatory History of the Nevada SIP? Pursuant to the Clean Air Amendments of 1970, the Governor of Nevada submitted the original Nevada SIP to EPA in January 1972. EPA approved certain portions of the original SIP and disapproved other portions under CAA section 110(a). See 37 FR 10842 (May 31, 1972). For some of the disapproved portions of the original SIP, EPA promulgated substitute provisions under CAA § 110(c). 1 This original SIP included various rules, codified as articles within the Nevada Air Quality Regulations (NAQR), and various statutory provisions codified in chapter 445 of the Nevada Revised Statutes (NRS). In the early 1980's, Nevada reorganized and re-codified its air quality rules into sections within chapter 445 of the Nevada Administrative Code (NAC). Today, Nevada codifies its air quality regulations in chapter 445B of the NAC. 1 Provisions that EPA promulgated under CAA section 110(c) in substitution of disapproved State provisions are referred to as Federal Implementation Plans (FIPs). Nevada adopted and submitted many revisions to the original set of regulations and statutes in the SIP, some of which EPA approved on February 6, 1975 at 40 FR 5508; on March 26, 1975 at 40 FR 13306; on January 9, 1978 at 43 FR 1341; on January 24, 1978 at 43 FR 3278; on August 21, 1978 at 43 FR 36932; on July 10, 1980 at 45 FR 46384; on April 14, 1981 at 46 FR 21758; on August 27, 1981 at 46 FR 43141; on March 8, 1982 at 47 FR 9833; on April 13, 1982 at 47 FR 15790; on June 18, 1982 at 47 FR 26386; on June 23, 1982 at 47 FR 27070; on March 27, 1984 at 49 FR 11626. Between 1984 and 2005, EPA approved very few revisions to Nevada's applicable SIP despite numerous changes that have been adopted by the State Environmental Commission. As a result, the version of the rules enforceable by NDEP was often quite different from the SIP version enforceable by EPA. Recently, Nevada submitted revisions to their SIP on February 16, 2005, January 12, 2006, and March 24, 2006. EPA approved various portions of these submittals on March 27, 2006 at 71 FR 15040; on August 31, 2006 at 71 FR 51766; on December 11, 2006 at 71 FR 71486; and on January 3, 2007 at 72 FR 11. C. What Is the Purpose of this Rulemaking? The purpose of this rulemaking is to bring the applicable SIP up to date. The regulations that are the subject of this rulemaking include a definition, a general rule for emergency episodes, and various monitoring regulations. II. EPA's Evaluation and Action A. How Is EPA Evaluating the Regulations? Generally, SIP regulations must be enforceable (see section 110(a) of the Act) and must not relax existing requirements (see sections 110(l) and 193). Relevant EPA guidance and policy documents that we used to help evaluate enforceability include “Review of State Implementation Plans and Revisions for Enforceability and Legal Sufficiency,” dated September 23, 1987, from J. Craig Potter, Assistant Administrator for Air and Radiation, *et al.* B. Do the Regulations Meet the Evaluation Criteria? We believe the following provisions are consistent with the relevant policy and guidance regarding enforceability and SIP relaxations: NAC 445B.134, NAC 445B.230, NAC 445B.258, NAC 445B.259, and NAC 445B.260. Generally, these provisions have been revised by the addition of certain clarifications and enhancements. The Technical Support Document
(TSD)dated March 5, 2007 has more information on our evaluation. C. Public Comment and Final Action. As authorized in section 110(k)(3) of the Act, EPA is fully approving the submitted rules because we believe they fulfill all relevant requirements. We do not think anyone will object to this approval, so we are finalizing it without proposing it in advance. However, in the Proposed Rules section of this **Federal Register** , we are simultaneously proposing approval of the same submitted rules. If we receive adverse comments by May 21, 2007, we will publish a timely withdrawal in the **Federal Register** to notify the public that the direct final approval will not take effect and we will address the comments in a subsequent final action based on the proposal. If we do not receive timely adverse comments, the direct final approval will be effective without further notice on June 19, 2007. This will incorporate these rules into the federally enforceable SIP. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment. III. Statutory and Executive Order Reviews Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 (Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), because it approves a state rule implementing a Federal standard. In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission; to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ). The Congressional Review Act, 5 U.S.C. 801 *et seq.* , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the **Federal Register** . A major rule cannot take effect until 60 days after it is published in the **Federal Register** . This action is not a “major rule” as defined by 5 U.S.C. 804(2). Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by June 19, 2007. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).) List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Intergovernmental relations, Reporting and recordkeeping requirements. Dated: April 4, 2007. Jane Diamond, Acting Regional Administrator, Region IX. Part 52, chapter I, title 40 of the Code of Federal Regulations is amended as follows: PART 52—[AMENDED] 1. The authority citation for part 52 continues to read as follows: Authority: 42 U.S.C. 7401 *et seq.* Subpart DD—Nevada 2. Section 52.1470 is amended by adding paragraph (c)(62) to read as follows: § 52.1470 Identification of plan.
(c)* * *
(62)The following plan revision was submitted on December 8, 2006, by the Governor's designee.
(i)Incorporation by reference.
(A)Nevada Division of Environmental Protection. ( *1* ) The following sections of Chapter 445B of the Nevada Administrative Code were adopted on September 6, 2006: 445B.134, 445B.230, 445B.258, 445B.259, and 445B.260. [FR Doc. E7-7546 Filed 4-19-07; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 70 [EPA-R09-OAR-2007-0090; FRL-8303-5] Clean Air Act Full Approval of Revisions to the State of Hawaii Operating Permit Program AGENCY: Environmental Protection Agency (EPA). ACTION: Direct final rule. SUMMARY: EPA is approving revisions to the State of Hawaii's (“Hawaii” or “State”) operating permit program that amend Hawaii's regulations for insignificant emissions units (IEUs). In an April 1, 2002 Notice of Deficiency published in the **Federal Register** , EPA notified Hawaii of EPA's finding that Hawaii's provisions for IEUs did not meet minimum Federal requirements. Hawaii has revised its program to correct the deficiency identified in the Notice of Deficiency and this action fully approves of those revisions. DATES: This operating permits program rule is effective on June 19, 2007 without further notice, unless EPA receives adverse comments by May 21, 2007. If we receive such comment, we will publish a timely withdrawal in the **Federal Register** to notify the public that these revisions will not take effect. ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-2007-0090, by one of the following methods: 1. Federal eRulemaking Portal: *www.regulations.gov* . Follow the on-line instructions. 2. E-mail: *Rios.Gerardo@epa.gov* . 3. Mail or deliver to Gerardo Rios, Permits Office Chief, Air Division (AIR-3), EPA Region IX, 75 Hawthorne Street, San Francisco, California, 94105. *Instructions:* All comments will be included in the public docket without change and may be made available online at www.regulations.gov, including any personal information provided, unless the comment includes Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Information that you consider CBI or otherwise protected should be clearly identified as such and should not be submitted through www.regulations.gov or e-mail. www.regulations.gov is an “anonymous access” system, and EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send e-mail directly to EPA, your e-mail address will be automatically captured and included as part of the public comment. 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. *Docket:* The index to the docket for this action is available electronically at www.regulations.gov and in hard copy at EPA Region IX, 75 Hawthorne Street, San Francisco, California. While all documents in the docket are listed in the index, some information may be publicly available only at the hard copy location (e.g., copyrighted material), and some may not be publicly available in either location (e.g., CBI). To inspect the hard copy materials, please schedule an appointment during normal business hours with the contact listed in the FOR FURTHER INFORMATION CONTACT section. FOR FURTHER INFORMATION CONTACT: Robert Baker, EPA Region IX, at
(415)972-3979, ( *Baker.Robert@epa.gov* ). SUPPLEMENTARY INFORMATION: Throughout this document, “we,” “us” and “our” refer to EPA. Table of Contents I. What Is the Operating Permit Program? II. What Is Being Addressed in This Document? III. What Are the Program Changes That EPA Is Approving? IV. What Is Involved in This Action? V. Public Comment and Final Action VI. Statutory and Executive Order Reviews I. What Is the Operating Permit Program? The Clean Air Act Amendments of 1990 required all state and local permitting authorities to develop operating permit programs that met certain federal criteria. In implementing the operating permit programs, the permitting authorities require certain sources of air pollution to obtain permits that contain all applicable requirements under the Clean Air Act (CAA). The focus of the operating permit program is to improve enforcement by issuing each source a permit that consolidates all of the applicable CAA requirements into a federally enforceable document. By consolidating all of the applicable requirements for a facility, the source, the public, and the permitting authorities can more easily determine what CAA requirements apply and how compliance with those requirements is determined. Sources required to obtain an operating permit under this program include “major” sources of air pollution and certain other sources specified in the CAA or in EPA's implementing regulations. Examples of major sources include those that have the potential to emit 100 tons per year or more of volatile organic compounds, carbon monoxide, lead, sulfur dioxide, nitrogen oxides (NO <sup>X</sup> ), or particulate matter (PM <sup>10</sup> ); those that emit 10 tons per year or more of any single hazardous air pollutant
(HAP)listed under the CAA; or those that emit 25 tons per year or more of a combination of HAPs. Hawaii's operating permits program was submitted to EPA in response to this directive. EPA granted interim approval to Hawaii's air operating permits program on December 1, 1994 (59 FR 61549). After Hawaii revised its program to address the conditions of the interim approval, EPA promulgated final full approval of Hawaii's title V operating permits program on November 26, 2001 (66 FR 62945). II. What Is Being Addressed in This Document? When an operating permit program does not fully meet the criteria outlined in the implementing regulations codified at 40 Code of Federal Regulations
(CFR)part 70, EPA may withdraw part 70 program approval if the permitting authority fails to take corrective action. 40 CFR 70.10(b) sets forth the procedures for program withdrawal, and requires as a prerequisite to withdrawal that the permitting authority be notified of any finding of deficiency by the Administrator and that the notice be published in the **Federal Register** . Deficiencies involving the provisions in the State's program that exempt insignificant activities from part 70 permitting requirements came to light as a result of the court decision in *Western States Petroleum Association (WSPA)* v. *Environmental Protection Agency* , 87 F.3d 280 (9th Cir. 1996). The court found in the WSPA case that EPA had acted inconsistently in its approval of the insignificant activities provisions in several part 70 programs, including the State of Hawaii's program. As a result, on April 1, 2002 EPA published a Notice of Deficiency for the State of Hawaii's title V operating permits program based upon the finding that Hawaii's provisions for IEUs did not meet minimum Federal requirements for program approval. This **Federal Register** notice describes the changes that the State has made to its operating permit program (Chapter 60.1 of the Hawaii Administrative Rules) to correct the deficiency identified in the Notice of Deficiency. III. What Are the Program Changes That EPA Is Approving? As discussed above, EPA published a Notice of Deficiency on April 1, 2002 that identified a deficiency in the State's title V program. In response to the Notice of Deficiency, the State revised its operating permit program to remove or correct the deficiency identified by EPA. The State made its revised rule available to public review and comments. On November 4, 2003, the State adopted the revisions. The revised program was submitted to EPA on November 14, 2003. We have included below a discussion of the identified deficiency, the conditions for correction, and a summary of how the State has corrected the deficiency. The Technical Support Document
(TSD)for this action includes more information about the State's submittal and more details of the revisions made. In the discussion here, we have listed the EPA cited deficiency identified in the April 1, 2002 **Federal Register** notice (see 62 FR 15385), followed by a brief description of the State's revisions to its operating permit program to remove the deficiency. *Insignificant activities:* Part 70 authorizes EPA to approve as part of a state program a list of IEUs which need not be included in the permit application, provided that an application may not omit information needed to determine the applicability of, or to impose, any applicable requirement, or to evaluate the fee amount required under the EPA-approved schedule. Nothing in part 70, however, authorizes a state to exempt IEUs from the testing, monitoring, recordkeeping, reporting, or compliance certification requirements of 40 CFR 70.6. Since the Hawaii program exempted IEUs from all permitting requirements including testing, monitoring, recordkeeping, reporting, and compliance certification requirements, EPA has required that Hawaii revise its IEU regulations. *State's response:* The State revised rule § 11-60.1-82(e) removing the provision exempting IEUs from permitting requirements. IV. What Is Involved in This Action? Today, we are fully approving the State's revised operating permit program (Chapter 60.1 of the Hawaii Administrative Rules). We have determined that the revisions made by the State remove or correct the deficiency identified by us in 2002. In addition, the State has made other changes to its operating permit program that are unrelated to the changes made to correct the identified program deficiency. EPA is not approving any action on these additional program changes in this notice. EPA will evaluate the additional program changes and will take appropriate action at a later date. V. Public Comment and Final Action As authorized in section 110(k)(3) of the Act, EPA is fully approving the revisions into the State of Hawaii State Implementation Plan because we believe it is consistent with title V of the Clean Air Act and 40 CFR Part 70. We are processing this action as a direct final action because the revisions made to the program to resolve the Notice of Deficiency are not controversial. However, in the Proposed Rules section of this **Federal Register** , we are simultaneously proposing approval of this same rule. If we receive adverse comments by May 21, 2007, we will publish a timely withdrawal in the **Federal Register** to notify the public that the direct final approval will not take effect and we will address the comments in a subsequent final action based on the proposal. Copies of the Hawaii submittal and other supporting documentation used in developing the approval are contained in docket files maintained at the EPA Region IX office. The docket is an organized and complete file of all the information submitted to, or otherwise considered by, EPA in the development of this full approval. The primary purposes of the docket are:
(1)To allow interested parties a means to identify and locate documents so that they can effectively participate in the approval process, and
(2)to serve as the record in case of judicial review. If we do not receive timely adverse comments, the direct final approval will be effective without further notice on June 19, 2007. Please note that if we receive adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, we may adopt as final those provisions of the revision that are not the subject of the adverse comment. VI. Statutory and Executive Order Reviews Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it approves a state rule implementing a Federal standard. In reviewing State operating permit programs submitted pursuant to Title V of the Clean Air Act, EPA will approve State programs provided that they meet the requirements of the Clean Air Act and EPA's regulations codified at 40 CFR part 70. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a State operating permit program for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews an operating permit program, to use VCS in place of a State program that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. List of Subjects in 40 CFR Part 70 Environmental protection, Administrative practice and procedure, Air pollution control, Intergovernmental relations, Operating permits, Reporting and recordkeeping requirements. Dated: April 4, 2007. Jane Diamond, Acting Regional Administrator, Region IX. 40 CFR part 70, chapter 1, title 40 of the Code of Federal Regulations is amended as follows: PART 70—[AMENDED] 1. The authority citation for part 70 continues to read as follows: Authority: 42 U.S.C. 7401, *et seq.* 2. Appendix A to part 70 is amended by adding paragraph
(c)under Hawaii to read as follows: Appendix A to Part 70—Approval Status of State and Local Operating Permits Programs Hawaii
(c)Department of Health: Program revisions submitted on November 14, 2003; submittal corrects the deficiency outlined in an April 1, 2002 Notice of Deficiency. These revisions are hereby granted full approval effective June 19, 2007. [FR Doc. E7-7550 Filed 4-19-07; 8:45 am] BILLING CODE 6560-50-P 72 76 Friday, April 20, 2007 Proposed Rules DEPARTMENT OF AGRICULTURE Rural Housing Service Rural Business-Cooperative Service Rural Utilities Service Farm Service Agency 7 CFR Parts 1942 and 4284 RIN 0570-AA28 Rural Business Enterprise Grant Program AGENCY: Rural Business-Cooperative Service, USDA. ACTION: Proposed rule. SUMMARY: The Rural Business-Cooperative Service (RBS), an agency within the United States Department of Agriculture (USDA), Rural Development proposes to implement 7 CFR part 4284, subpart B in order to have an all-inclusive processing and servicing regulation. USDA Rural Development intends to provide a more user-friendly regulation that will be a better resource for public understanding and improvement in program administration. DATES: Written comments on this proposed rule must be received on or before June 19, 2007 to be assured of consideration. The comment period for the information collection under the Paperwork Reduction Act of 1995 continues through June 19, 2007. ADDRESSES: You may submit comments to this rule by any of the following methods: • *Federal eRulemaking Portal:* *http://www.regulations.gov.* Follow instructions for submitting comments. • *Mail:* Submit written comments via the U.S. Postal Service to the Branch Chief, Regulations and Paperwork Management Branch, Rural Development U.S. Department of Agriculture, STOP 0742, 1400 Independence Avenue, SW., Washington, DC 20250-0742. • *Hand Delivery/Courier:* Submit written comments via Federal Express mail or another courier service requiring a street address to the Branch Chief, Regulations and Paperwork Management Branch, Attention: Cheryl Thompson, Rural Development, U.S. Department of Agriculture, 300 7th Street, SW., 7th Floor, Washington, DC 20024. All written comments will be available for public inspection during regular work hours at the 300 7th Street, SW., 7th Floor, address listed above. FOR FURTHER INFORMATION CONTACT: Cindy Mason, Loan Specialist, Business Programs, USDA Rural Development (U.S. Department of Agriculture) STOP 3225, 1400 Independence Ave., SW., Washington, DC 20250, Telephone
(202)690-1433. The TDD number is
(800)795-3272 or
(202)720-6382. SUPPLEMENTARY INFORMATION: Classification This rule has been determined to be non-significant under Executive Order 12866 and has, therefore, not been reviewed by the Office of Management and Budget (OMB). Programs Affected The Catalog of Federal Domestic Assistance number for the program impacted by this action is 10.769, Rural Business Enterprise Grants. Intergovernmental Review The Rural Business Enterprise Grant
(RBEG)Program is subject to the provisions of Executive Order 12372, which requires intergovernmental consultation with State and local officials. USDA Rural Development will conduct intergovernmental consultation in the manner delineated in RD Instruction 1940-J, “Intergovernmental Review of Rural Development Programs and Activities,” and 7 CFR part 3015, subpart V. Regulatory Flexibility Act In compliance with the Regulatory Flexibility Act (5 U.S.C. 601-602), the undersigned has determined and certified by signature of this document that this rule will not have a significant economic impact on a substantial number of small entities. New provisions included in this rule will not impact a substantial number of small entities to a greater extent than large entities. Therefore, a regulatory flexibility analysis was not performed. Civil Justice Reform This rule has been reviewed under Executive Order 12988, Civil Justice Reform. In accordance with this rule:
(1)All State and local laws and regulations that are in conflict with this rule will be preempted,
(2)no retroactive effect will be given to this rule, and
(3)administrative proceedings in accordance with 7 CFR part 11 must be exhausted before bringing suit in court challenging action taken under this rule, unless those regulations specifically allow bringing suit at an earlier time. Environmental Impact Statement This document has been reviewed in accordance with 7 CFR part 1940, subpart G, “Environmental Program.” RBS has determined that this action does not constitute a major Federal action significantly affecting the quality of the human environment, and, in accordance with the National Environmental Policy Act of 1969, Pub. L. 91-190, an Environmental Impact Statement is not required. Unfunded Mandates Reform Act Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub. L. 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Under section 202 of the UMRA, RBS must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures to State, local or tribal governments, in the aggregate, or to the private sector of $100 million or more in any 1 year. When such a statement is needed for a rule, section 205 of UMRA generally requires USDA Rural Development to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, more cost-effective, or least burdensome alternative that achieves the objectives of the rule. This rule contains no Federal mandates (under the regulatory provisions of title II of the UMRA) for State, local, and tribal governments or the private sector. Thus, this rule is not subject to the requirements of sections 202 and 205 of the UMRA. Federalism It has been determined under Executive Order 13132, Federalism, that this rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. The provisions contained in this rule will not have a substantial direct effect on States or their political subdivisions or on the distribution of power and responsibilities among the various levels of government. Paperwork Reduction Act In accordance with the Paperwork Reduction Act of 1995, USDA Rural Development will seek OMB approval of the reporting and recordkeeping requirements contained in this proposed rule. E-Government Act Compliance USDA Rural Development is committed to complying with the E-Government Act, to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes. For information pertinent to E-GOV compliance related to this proposed rule, please contact Jeanette Waters on
(202)720-4059. *Title:* Rural Business Enterprise Grant Program. *Type of Request:* New collection. *Abstract:* The Rural Business Enterprise Grant
(RBEG)Program is authorized under section 310B(c) of the Consolidated Farm and Rural Development Act, as amended. The purpose of the program is to finance or facilitate the development of small and emerging private business enterprises; to create, expand or operate rural distance learning networks or programs that provide educational or job training instruction related to the potential employment or job advancement of adult students; and to provide technical assistance and training to rural communities for the purpose of improving passenger transportation services or facilities. An additional purpose authorized under section 310B(f) of the Consolidated Farm and Rural Development Act is for statewide broadcasting systems that provide information on agriculture and other issues of importance to farmers and other rural residents. USDA Rural Development intends to incorporate all of the authorized purposes discussed above into one program regulation, 7 CFR part 4284, subpart B. This subpart contains various requirements for information from grantees, and some requirements may cause the grantees to require information from other parties. The information requested is vital for USDA Rural Development to be able to process applications in a responsible manner, make prudent program decisions, and effectively monitor the grantees' activities to protect the Government's financial interest and ensure that funds obtained from the Government are used appropriately. This collection of information is necessary in order to implement 7 CFR part 4284, subpart B. *Estimate of Burden:* Public reporting burden for this collection of information is estimated to average 7 hours per response. *Respondents:* Nonprofits and public bodies. *Estimated Number of Respondents:* 700. *Estimated Number of Responses per Respondent:* 12. *Estimated Number of Responses:* 8,160. *Estimated Total Annual Burden on Respondents:* 53,435. Copies of this information collection can be obtained from Cheryl Thompson, Regulations and Paperwork Management Branch, at
(202)692-0043. Comments Comments are invited on:
(a)Whether the proposed collection of information is necessary for the proper performance of the functions of USDA Rural Development, including whether the information will have practical utility;
(b)the accuracy of the USDA Rural Development estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(c)ways to enhance the quality, utility, and clarity of the information to be collected; and
(d)ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Comments may be sent to Cheryl Thompson, Regulations and Paperwork Management Branch, U.S. Department of Agriculture, Rural Development, STOP 0742, 1400 Independence Ave., SW., Washington, DC 20250. All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record. Background The current 7 CFR part 1942, subpart G, has recently been updated with a rural area definition change made by section 6020 of the Farm Security and Rural Investment Act of 2002; however, the regulation has not been completely reissued since 1992. USDA Rural Development consistently reissues administrative notices year after year to our field offices regarding clarifications and policies on our program. This guidance should officially be made part of the regulation through the Federal government regulatory review process and allow the public the opportunity to make comments on the policy decisions. 7 CFR part 1942, subpart G, along with Attachment 1, is currently used to administer the program and at times can be difficult to follow. USDA Rural Development hopes to provide a more user-friendly regulation with the implementation of 7 CFR part 4284, subpart B. The existing regulation for the Rural Business Enterprise Grants and Television Demonstration Grants founds in 7 CFR part 1942, subpart G, will be removed upon publication of the final rule. List of Subjects 7 CFR Part 1942 Business and industry, Grant programs—Housing and community development, Industrial park, Rural areas. 7 CFR Part 4284 Business and industry, Economic development, Grant programs—Housing and community development, Rural areas. Therefore, chapters XVIII and XLII, title 7, of the Code of Federal Regulations are proposed to be amended as follows: CHAPTER XVIII—RURAL HOUSING SERVICE, RURAL BUSINESS-COOPERATIVE SERVICE, RURAL UTILITIES SERVICE, AND FARM SERVICE AGENCY, DEPARTMENT OF AGRICULTURE PART 1942—ASSOCIATIONS 1. The authority citation for part 1942 continues to read as follows: Authority: 5 U.S.C. 301, 7 U.S.C. 1932, 7 U.S.C. 1989, and 16 U.S.C. 1005. Subpart G [Removed and Reserved] 2. Subpart G of part 1942 is removed and reserved. CHAPTER XLII—RURAL BUSINESS-COOPERATIVE SERVICE AND RURAL UTILITIES SERVICE, DEPARTMENT OF AGRICULTURE PART 4284—GRANTS 3. The authority citation for part 4284 is revised to read as follows: Authority: 5 U.S.C. 301, 7 U.S.C. 1932, 7 U.S.C. 1989, and 16 U.S.C. 1005. 4. Subpart B is added to part 4284 to read as follows: Subpart B—Rural Business Enterprise Grant Program Sec. 4284.101 Purpose. 4284.102 Policy. 4284.103 Definitions. 4284.104 Exception authority. 4284.105 [Reserved] 4284.106 Applicant eligibility requirements. 4284.107-4284.108 [Reserved] 4284.109 Eligible purposes. 4284.110 Ineligible purposes. 4284.111-4284.112 [Reserved] 4284.113 Project eligibility. 4284.114-4284.115 [Reserved] 4284.116 Small business eligibility certification. 4284.117 Small business eligibility exception. 4284.118 Private tribally-owned business. 4284.119-4284.120 [Reserved] 4284.121 Grant ownership. 4284.122 Leveraging. 4284.123-4284.124 [Reserved] 4284.125 Preapplication. 4284.126 Preapplication contents. 4284.127 Scope of work requirements. 4284.128 Other narrative information. 4284.129-4284.130 [Reserved] 4284.131 Program income. 4284.132 Indirect cost rate. 4284.133-4284.134 [Reserved] 4284.135 Civil rights requirements. 4284.136 Environmental review. 4284.137-4284.138 [Reserved] 4284.139 Project selection criteria. 4284.140-4284.141 [Reserved] 4284.142 Application. 4284.143 Application contents. 4284.144 Revolving loan fund work plan requirements. 4284.145-4284.148 [Reserved] 4284.149 Application selection. 4284.150-4284.151 [Reserved] 4284.152 Letter of Conditions. 4284.153 Grant Agreement. 4284.154-4284.155 [Reserved] 4284.156 Time frame for use of grant funds. 4284.157 Financial management system. 4284.158 Grant disbursement. 4284.159-4284.160 [Reserved] 4284.161 Insurance requirements. 4284.162-4284.163 [Reserved] 4284.164 Changes in scope of work, work plan or budget. 4284.165-4284.166 [Reserved] 4284.167 Reporting requirements. 4284.168-4284.169 [Reserved] 4284.170 Site visits. 4284.171-4284.172 [Reserved] 4284.173 Record retention. 4284.174-4284.177 [Reserved] 4284.178 Disposition of real property, equipment, and supplies. 4284.179-4284.180 [Reserved] 4284.181 Construction requirements. 4284.182-4284.183 [Reserved] 4284.184 Clarification of revolving loan fund operation. 4284.185-4284.188 [Reserved] 4284.189 Grant termination. 4284.190 Transfer and assumption. 4284.191-4284.193 [Reserved] 4284.194 Appeal rights. 4284.195-4284.200 [Reserved] Subpart B—Rural Business Enterprise Grant Program § 4284.101 Purpose. This subpart outlines policies and procedures for administering the Rural Business Enterprise Grant
(RBEG)Program. The purpose of this program is to provide grants to stimulate economic activity and employment in rural areas by:
(a)Financing and facilitating development of small and emerging private business enterprises;
(b)Creating, expanding, and operating rural distance learning networks or rural learning programs that provide educational or job training instruction related to the potential employment or job advancement of adult (as defined per State law) students;
(c)Providing technical assistance and training to rural communities for the purpose of improving passenger transportation services or facilities; and
(d)Financing statewide broadcasting systems that provide information on agriculture and other issues of importance to farmers and other rural residents. § 4284.102 Policy.
(a)The RBEG Program will be administered under this subpart; however, the requirements of 7 CFR parts 3015, 3016, 3017, 3018, 3019, and 3052 also govern the United States Department of Agriculture
(USDA)grant programs. USDA Rural Development has attempted to address these requirements in this subpart. Nevertheless, any conflicts between those parts and this subpart will be resolved in favor of the applicable 7 CFR parts of 3015, 3016, 3017, 3018, 3019, and 3052.
(b)Grants will not be awarded under this program unless all eligibility requirements are met in accordance with this subpart.
(c)Any processing or servicing activity conducted pursuant to this subpart involving authorized assistance to USDA Rural Development employees, members of their families, close relatives, or business or close personal associates is subject to the provisions of RD Instruction 1900-D. Applicants will be required to identify any relationship or association with a USDA Rural Development employee.
(d)Grantees and USDA Rural Development program administrators will be held accountable for following the procedures provided in this subpart. § 4284.103 Definitions. The following definitions pertain to this subpart: *Agriculture production.* The cultivation, production, growing, raising, feeding, housing, breeding, hatching, or managing of crops, plants, animals or birds, either for fiber, food for human consumption or livestock feed. *Cognizant agency.* The Federal agency that has the largest dollar value of awards with a grantee and the one responsible for negotiating and approving indirect cost rates for that grantee. *Conflict of interest.* When the grantee's immediate family, employees, or board of directors including their immediate families have a legal or personal financial interest in the recipient(s) receiving the benefits or services of the grant. *Corporation.* A body of persons granted a charter legally by a state government or Federally recognized Indian tribe recognizing it as a separate entity having its own rights, privileges, and liabilities distinct from its members. *Cost of goods sold.* The amount determined by subtracting the value of the ending merchandise inventory from the sum of the beginning merchandise inventory and the net purchase for the fiscal period. *Grant closeout.* When all required work is completed, administrative actions relating to the completion of work and expenditures of funds have been accomplished, and USDA Rural Development accepts final expenditure information. *Grant period.* The period of time to complete a project and receive grant funds as reimbursement for allowable expenses. *Gross profit.* Net sales minus cost of goods sold. *Indirect cost rate.* A percentage of an organization's total indirect costs to its direct cost base. *Long-term.* The period of time covered by the three most recent decennial censuses of the United States to the present. *Net sales.* Gross sales less discounts, allowances and returns. *Non-metropolitan median household income.* Median household income of the state's non-metropolitan counties and portions of metropolitan counties outside of cities, towns, and places of 50,000 or more population. *Predominantly rural coverage area.* The area covered by the signal of a statewide, private, nonprofit public television system that is more than 50 percent of the rural (as defined in this section) population according to the latest decennial census of the United States. *Private business.* A business owned and controlled either by individuals or by a nonpublic entity, which is legally organized under State law or under the laws or codes of a Federally recognized Indian tribe. *Private nonprofit corporation.* A corporation created for private purposes including Federal Credit Unions if properly organized as a private nonprofit corporation (not controlled or associated with government interest) that does not distribute any part of its income to its members and has a 501(c)(3) Internal Revenue Service tax-exempt revenue code. *Program income.* Gross income earned by the grantee directly generated by the grant-supported activity or earned as a result of the grant award during the grant period. *Project.* The real property, equipment, supplies, revolving loan fund, technical assistance or any other assistance funded under this program. *Public body.* A state; county; city; township; and incorporated towns and villages, boroughs, authorities, districts; and Federally recognized Indian tribes. *Qualified national nonprofit organization.* A corporation created for private purposes (not controlled or associated with government interest) that does not distribute any part of its income to its members and has a 501(c)(3) Internal Revenue Service tax-exempt revenue code. The corporation must also operate in a Multi-state area. *Revolved funds.* The portion of the revolving loan fund that is not composed of USDA Rural Development grant funds including principal and interest payments and fees collected on loans made from the revolving loan fund. Revolved funds shall not be considered Federal funds. *Revolving loan fund.* A fund created with grant funds under this program and/or funds from other sources used to make loans to small businesses for economic development and job creation purposes that uses the loan repayments to make additional loans in accordance with the approved work plan. *Rural and rural area.* Any area other than a city or town that has a population of greater than 50,000 inhabitants and the urbanized area contiguous and adjacent to such a city or town according to the latest decennial census of the United States. *Rural Development.* For purposes of this regulation, the Rural Business-Cooperative Service (RBS), an Agency of the United States Department of Agriculture, or a successor Agency, will be referred to as USDA Rural Development. *Rural distance learning networks.* A telecommunication link between instructors and adult students. *Rural distance learning programs.* A system or means of providing education or job training instruction relating to potential employment or job advancement of adult students. *Small and emerging private business enterprise.* Any private business that will employ 50 or fewer new employees and has less than $1 million in projected gross profit (per generally accepted accounting principles). Small and emerging private business enterprise is referred to as “small business” in this subpart. *State.* Any of the 50 States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands of the United States, Guam, American Samoa, the Commonwealth of the Northern Mariana Islands, the Republic of Palau, the Federated States of Micronesia, and the Republic of the Marshall Islands. *Statewide.* Having a coverage area of not less than 90 percent of the population of a State and not less than 80 percent of the rural land area of the State. *Technical assistance.* Providing support by analyzing, evaluating, or training to solve a problem. USDA Rural Development will determine whether a specific activity qualifies as technical assistance. *Third-party, in-kind contributions.* The value of non-cash contributions provided by non-Federal third parties. Third-party, in-kind contributions may be in the form of real property, equipment, supplies and other expendable property. The value of the goods and services must directly benefit and be specifically identifiable to the project. *Total project cost.* The sum of all costs associated with a completed, operational project. § 4284.104 Exception authority. The Administrator may, in individual cases, make an exception to any requirement or provision of this subpart that is not inconsistent with the authorizing statute or any applicable law if the Administrator determines that requirement or provision would adversely affect the government's interest. § 4284.105 [Reserved] § 4284.106 Applicant eligibility requirements. The applicant eligibility requirements will be listed by type of grant followed by other requirements that must be met by the applicant for eligibility unless otherwise noted.
(a)*Project grant (other than paragraphs
(b)or
(c)of this section).* Applicants must be a public body or a private, nonprofit corporation.
(b)*Passenger transportation technical assistance grant.* Applicants must be a qualified national nonprofit organization with experience in providing technical assistance and training to rural communities for the purpose of improving passenger transportation service or facilities.
(c)*Television demonstration grant.* Applicants must be a statewide, private, nonprofit public television system (licensed by the Federal Communications Commission under its non-commercial classification), whose coverage area is predominantly rural, for the purpose of demonstrating the effectiveness of such systems in providing information on agriculture and other issues of importance to farmers and other rural residents. The National Public Broadcasting System makes the determination of eligibility for statewide and predominantly rural coverage area as defined in this subpart.
(d)*Other applicant eligibility requirements.* Applicants must also meet the following requirements to be eligible for assistance. A certification must be signed stating that the applicant has:
(1)The legal authority to carry out the purpose(s) of the proposed project;
(2)No delinquent debt to the Federal Government or any outstanding Federal judgments;
(3)At least 3 years experience as an organization in the proposed type of project. The only exception is if the project is for a revolving loan fund and a third-party with the required experience will be hired to do the credit and financial analysis. The applicant may certify if this is the case;
(4)No conflict of interest in the proposed project;
(5)Ownership and control of the proposed project; and
(6)At least 51 percent ownership by those who are either citizens of the United States or reside in the United States after being legally admitted for permanent residence (applies only if the applicant is a private nonprofit). §§ 4284.107-4284.108 [Reserved] § 4284.109 Eligible purposes. Grant funds may be used to do the following; however, if the grant is to benefit a small business by using purposes defined in paragraphs
(a)through
(c)of this section, the small business must lease any real property or equipment from the applicant at rates that would ensure sustainability of the project (i.e., the grantee's cost of operating the facility including insurance premiums):
(a)Purchase and develop land, easements, and right-of-ways;
(b)Construct or improve buildings; plants; access streets and roads; parking areas; utilities; and pollution control and abatement facilities;
(c)Purchase of machinery and equipment;
(d)Provide technical assistance or training;
(e)Create, expand, and operate rural distance learning networks or rural learning programs that provide educational instruction or job training instruction related to potential employment or job advancement of adult (as defined per State law) students. Paragraphs
(a)through
(d)of this section may be utilized for this purpose;
(f)Establish or recapitalize a revolving loan fund;
(g)Pay for reasonable fees and charges for professional services necessary for the planning and development of a construction project;
(h)Pay off an interim financing loan incurred in connection with a construction project when a preapplication is received by USDA Rural Development before construction is started;
(i)Pay for on-site technical assistance and training to local and regional governments, public transit agencies, and related nonprofit and for-profit organizations in rural areas, the development of training materials, and the provision of necessary training assistance to local officials and agencies in rural areas for the purpose of improving passenger transportation services or facilities; and
(j)Pay for capital equipment expenditures, start-up and program costs, and other costs necessary to the operation of television demonstration programs. § 4284.110 Ineligible purposes. Grant funds may not be used for the following:
(a)Costs incurred on the project before receipt of the completed preapplication by USDA Rural Development unless it is for professional services necessary for the planning and development of a construction project;
(b)Agriculture production;
(c)Residential housing;
(d)Any illegal or gambling activities;
(e)Lending and investment institutions and insurance companies;
(f)Charitable institutions and fraternal organizations;
(g)Duplicating current services or replacing or substituting support previously provided beyond a 2-year period of time;
(h)Paying the costs of preparing the preapplication or application package for funding under this program;
(i)Technical assistance which duplicates assistance provided by the Forest Service to implement an action plan under the National Forest-Dependent Rural Communities Economic Diversification Act;
(j)Making loans from a revolving loan fund that do not have reasonable rates and terms as compared to what is charged in the area where the project is located;
(k)Transferring jobs from one area to another or increasing the production of goods when there is not sufficient demand or the availability of services or facilities;
(l)Funding part of a project that is dependent on other funding unless there is a firm commitment in writing of other funding to ensure completion of the project;
(m)Projects where USDA Rural Development determines that construction was initiated to avoid Federal environmental compliance requirements;
(n)Financial assistance requests in excess of $500,000;
(o)Passing grant funds directly to a third-party recipient;
(p)Using technical assistance to pay for operating expenses of a small business.
(q)Operating expenses of an eligible applicant unless it is for television demonstration projects or the salaries and expenses related to employees who directly perform technical assistance to small businesses, adult students or passenger transportation projects;
(r)Fund political activities; and
(s)Paying for construction or improvement projects when the applicant is leasing the real property where the construction or improvement will occur. §§ 4284.111-4284.112 [Reserved] § 4284.113 Project eligibility. The applicant must provide supporting documentation to illustrate the project:
(a)Has a demonstrated need;
(b)Is economically feasible to ensure sustainability beyond grant assistance unless the project is for a feasibility study;
(c)Is located in a rural area;
(d)Will benefit small business or provide job placement or advancement for adult students as the end result of the project unless the project is for passenger transportation or television demonstration grants; and
(e)Is measurable to document performance outcomes and demonstrate results of the program. §§ 4284.114-4284.115 [Reserved] § 4284.116 Small business eligibility certification. Any small business receiving assistance under this program must be a separate, private business and cannot be the grantee or any affiliate thereof. Each small business must sign a certification stating they:
(a)Meet the small and emerging private business enterprise definition contained in § 4284.103 of this subpart;
(b)Are located in a rural area as defined in § 4284.103 of this subpart;
(c)Have no delinquent debt to the Federal Government or any outstanding Federal judgments;
(d)Have no conflict of interest in the proposed project;
(e)Have at least 51 percent ownership by those who are either citizens of the United States or reside in the United States after being legally admitted for permanent residence. § 4284.117 Small business eligibility exception. If the small business is a nonprofit entity or other tax-exempt organization (as defined by the Internal Revenue Service revenue codes) located in a city, town or unincorporated area with a population of 5,000 or less and has a principal office on land of an existing or former Native American reservation, the small business does not need to meet the small business definition contained in § 4284.103 of this subpart. However, the small business receiving assistance must sign a certification stating they meet the requirements of paragraphs
(b)through
(e)defined in § 4284.116. § 4284.118 Private tribally-owned business. For a tribally-owned business to be considered a private business, it must be held through a separate entity, such as a tribal corporation. The corporation may be owned by the tribe and distribute profits to the tribe. However, the governing board must be independent from the tribal government and elected or appointed for a specific time period. Board members must not be subject to removal without cause by the tribal government. A majority of the board members must not now or in the future, as long as they are board members, be members of the tribal council or other governing board of the tribe. Tribally-owned small businesses will be required to sign a small business certification in accordance with either § 4284.116 or § 4284.117. §§ 4284.119-4284.120 [Reserved] § 4284.121 Grant ownership. The grantee must have ownership and control of the project until transfer, disposition, or termination of the project occurs.
(a)The grantee must retain ownership of any real property that will be purchased or improved with grant funds. In the case of installation or improvements to utilities or streets, the grantee does not have to own the land, utility, or street that is improved in the public right of way, but must retain ownership of the land surrounding the improvements.
(b)The grantee must retain ownership of any equipment or supplies acquired with grant funds.
(c)The grantee must establish a separate bank account for a revolving loan fund, secure the account by signing a control agreement (available from any USDA Rural Development State Office) and direct and manage the fund.
(d)The grantee must oversee and control technical assistance, passenger transportation and television demonstration projects until the grants are closed out. § 4284.122 Leveraging. Supplemental funding at a minimum of 20 percent of the total project cost must be included in the project. Supplemental funds may be from cash injection by the applicant, financial institutions, state or local governmental sources, or third-party, in-kind contributions. Third-party, in-kind contributions will be limited to 10 percent of supplemental funding and USDA Rural Development will advise if the third-party, in-kind contributions are acceptable. Applicants may not use third-party, in-kind contributions for revolving loan fund projects. Other Federal grant awards cannot be used to meet the 20 percent leveraging match. §§ 4284.123-4284.124 [Reserved] § 4284.125 Preapplication. A preapplication is required to establish communication between the potential applicant and USDA Rural Development, determine the potential applicant's eligibility, and identify projects which have little or no chance for funding before applicants incur significant costs. § 4284.126 Preapplication contents. A complete preapplication must be submitted to the USDA Rural Development State Office where the project is located. Multi-state projects must be submitted to the USDA Rural Development State Office where the applicant is headquartered. A complete preapplication must include:
(a)An SF-424, “Application for Federal Assistance,” including the appropriate non-construction (SF-424A and SF-424B) or construction (SF-424C and SF-424D) budget and assurance forms, and a Dun and Bradstreet Universal Numbering System
(DUNS)number handwritten or typed on the SF-424;
(b)Intergovernmental review comments from the State Single Point of Contact, or evidence that the State has elected not to review the program under Executive Order 12372. Applicants can obtain the necessary state clearinghouse contacts from the USDA Rural Development State Office where the project is located;
(c)Evidence of legal existence including a copy of the articles of incorporation, by-laws, and certificate of good standing or incorporation;
(d)Form RD 1940-20, “Request for Environmental Information,” unless the project is considered a categorical exclusion in accordance with 7 CFR part 1940, subpart G. Applicants can verify if their project is a categorical exclusion with the USDA Rural Development State Office where the project is located;
(e)A signed applicant eligibility certification;
(f)A copy of the most recent year-end financial statements that should include a balance sheet and income statement prepared in accordance with generally accepted accounting principles;
(g)A preliminary architectural or engineering report for construction projects that includes a description of the facility; including size, location, related facilities, schematic cost estimate, and schematic plans; and
(h)A scope of work. § 4284.127 Scope of work requirements. The scope of work is a detailed written narrative identifying the aspects of a proposed project. It must be completed for all projects and contain the following:
(a)Specific purposes, objectives, and need for grant funds including identification of the proposed project in a local or regional plan;
(b)Timeframes to complete the proposed project;
(c)Names and responsibilities of key personnel who will carry out the objectives of the proposed project;
(d)Experience specifically related to the type of project proposed;
(e)Availability of other funds and sources;
(f)Number and type of small businesses to be assisted as a result of the grant including number of jobs created and/or saved and other anticipated goals and/or benefits of the proposed project, if applicable. This should be based on letters of interest or commitments;
(g)Number of adult students to be assisted as a result of the grant and other anticipated goals and/or benefits of the proposed project when the grant is for a rural distance learning network or rural learning program, if applicable. This should be based on letters of interest or commitments; and
(h)Anticipated goals and/or benefits for passenger transportation or television demonstration projects as a result of the grant, if applicable. § 4284.128 Other narrative information. The following narrative information should be addressed in your preapplication to assist USDA Rural Development in assigning points under the scoring criteria. You may address it in the scope of work or in a separate document.
(a)Documented statistical information on population, unemployment rate, and median household income for the area to be served by the proposed project;
(b)Documented information on sudden and severe economic dislocation produced by such factors as the departure or downsizing of a major employer, or natural disaster, if applicable; and
(c)Documented statistical information on long-term decline in population, if applicable. §§ 4284.129-4284.130 [Reserved] § 4284.131 Program income. Program income must be addressed in the SF-424 and the respective budget forms. Any program income earned during the grant period may be retained by the grantee to further the objectives and goals of the project. § 4284.132 Indirect cost rate. The maximum indirect cost rate USDA Rural Development will pay is 25 percent of the grant request unless the grantee already has a negotiated agreement with its cognizant agency. A copy of the negotiated agreement must be provided with the preapplication. §§ 4284.133-4284.134 [Reserved] § 4284.135 Civil rights requirements.
(a)All grants made under this subpart are subject to Title VI of the Civil Rights Act of 1964, Title IX of the Education Amendments of 1972, Section 504 of the Rehabilitation Act of 1973, the Age Discrimination Act of 1975, and part 1901, subpart E of this title.
(b)USDA Rural Development will inform grantees of their civil rights requirements in accordance with paragraph
(a)of this section. Grantees may be required to collect certain information on their project or program to ensure that they are serving the public without discrimination. § 4284.136 Environmental review.
(a)All grants under this subpart are subject to the environmental requirements of 7 CFR part 1940, subpart G before any application is approved. The grantee must not take any actions that would have an adverse impact on the environment or limit the range of alternatives USDA Rural Development considers during the environmental review. If USDA Rural Development finds evidence that construction was initiated to avoid compliance requirements, the preapplication will not be considered for assistance. Any mitigation measures will be included in the Letter of Conditions or other grant approval document. The grantee is responsible for communicating the mitigation measures to the project designers for inclusion in the project construction documents.
(b)USDA Rural Development will conduct an initial environmental review on revolving loan fund projects and a separate environmental review on each loan the grantee is proposing to provide funds for until all grant funds have been expended. However, if the grantee has one loan project committed to use the total amount of the grant, USDA Rural Development will only conduct an individual project review.
(c)The grantee will be responsible for preparation of environmental reviews after they have lent out an amount equal to the grant award. Preparation will be accomplished using professional consultant services and the review document will conform to the requirements and formats of 7 CFR part 1940, subpart G. §§ 4284.137-4284.138 [Reserved] § 4284.139 Project selection criteria. USDA Rural Development will evaluate the preapplication and give it a priority score based on criteria in this section. This process will assist USDA Rural Development in prioritizing for funding approval. Any scoring criteria not addressed will automatically receive zero points. Applicants may average any figures that are based on the rural area to be served. All written commitment supporting documentation for priority points must be submitted to USDA Rural Development no later than the application stage. Points will be distributed as follows:
(a)*Population.* Figures from the latest decennial census of the United States must be used to score population on the area to be served by the proposed project as follows:
(1)The proposed project will be located in areas of under 5,000 population—15 points;
(2)The proposed project will be located in areas of between 5,000 and 15,000 population—10 points;
(3)The proposed project will be located in areas of between 15,001 and 25,000 population—5 points.
(b)*Economic Conditions.* Figures must be used for the area to be served by the proposed project as follows:
(1)*Unemployment rate.* Unemployment figures must come from the most recent published unemployment data by the Bureau of Labor Statistics, U.S. Department of Labor or State Department of Labor Statistics. Projects serving all of a State's rural area or Multi-State rural areas will compare State unemployment rates to the national unemployment rate.
(i)The proposed project will be located in areas where the unemployment rate exceeds the State rate by 50 percent or more—20 points;
(ii)The proposed project will be located in areas where the unemployment rate exceeds the State rate by 25 percent or more but less than 50 percent—10 points;
(iii)The proposed project will be located in areas where the unemployment rate exceeds the State rate by less than 25 percent—5 points.
(2)*Median household income.* Income figures must come from the latest decennial census of the United States, updated according to changes in the consumer price index. The poverty line figure used must be as defined in section 673(2) of the Community Services Block Grant Act (42 U.S.C. 9902 (2)) for a family of four for the State. Projects serving all of a State's rural area or Multi-State rural areas will compare State non-metropolitan median household incomes to the national poverty line.
(i)The proposed project will be located in areas where the median household income is less than poverty line—25 points;
(ii)The proposed project will be located in areas where the median household income is more than the poverty line, but less than 85 percent of the State non-metropolitan median household income—15 points;
(iii)The proposed project will be located in areas where the median household income is between 85 percent and 100 percent of the State non-metropolitan median household income—10 points;
(c)*Supplemental funding.* Written commitments from other financing sources must be provided with the application. Third-party, in-kind contributions will not be considered under this criterion only as part of the matching requirement. Points are awarded as follows:
(1)The proposed project will have supplemental funding in an amount equal to or greater than 75 percent of total project cost—25 points;
(2)The proposed project will have supplemental funding in an amount equal to or more than 50 percent, but less than 75 percent of total project cost—15 points;
(3)The proposed project will have supplemental funding in an amount equal to or more than 25 percent, but less than 50 percent of total project cost—10 points.
(4)The proposed project will have supplemental funding above 20 percent, but less than 25 percent of the total project cost—5 points.
(d)*Full-time direct jobs created or saved.* Evidence of full-time direct jobs created or saved must be included in the application. Full-time direct jobs must be calculated based on the total project cost and scored as follows:
(1)The proposed project will create or save one job per each $15,000 of the total project cost—10 points;
(2)The proposed project will create or save one job per each $25,000 of the total project cost—5 points.
(e)*Fund utilization.* Points will be awarded if the proposed project will utilize grant funds of $100,000 or less—25 points;
(f)*Local or regional plans.* The proposed project is identified in a local or regional economic development plan adopted by the area to be served by the project—5 points. A copy of the plan must be included with the application to receive points.
(g)*Small business.* The small business to be assisted is a nonprofit entity or other tax-exempt organization (as defined by the Internal Revenue Service revenue codes) located in a city, town or unincorporated area with a population of 5,000 or less and has a principal office on land of an existing or former Native American reservation—5 points. Evidence of organization and location must be provided with the application.
(h)*Discretionary points.* USDA Rural Development may assign up to additional 30 points for discretionary items if the proposed project is an initial grant. An initial grant means that this would be the first time grant funds are being requested for the proposed project. Subsequent grant requests are not eligible for discretionary points. Evidence must be provided in the application to receive points. In addition, discretionary points will be awarded in the following situations:
(1)The proposed project is located in a Champion Community—5 points;
(2)The area to be served by the proposed project has had a loss of a major employer or industry within the last 3 years—5 points;
(3)The area to be served by the proposed project has had a Presidential or Secretarial natural disaster designation within the last 3 years—5 points;
(4)The area to be served by the proposed project has had a long-term decline in population—5 points;
(5)This would be the applicant's first grant award under the RBEG Program—10 points; §§ 4284.140—4284.141 [Reserved] § 4284.142 Application. USDA Rural Development will issue Form AD-622, “Notice of Preapplication Review Action,” or similar letter notifying the applicant that they are eligible to complete and submit an application or ineligible for assistance under this subpart due to legal existence or intended use of grant funds. § 4284.143 Application Contents. A complete application will be submitted to the USDA Rural Development State Office and include the following:
(a)An updated SF-424 signed by the applicant, if necessary;
(b)Preliminary plans and specifications for construction projects; which will include a preliminary floor plan, site plan and elevations in sufficient detail for preparing an appraisal along with a preliminary estimate of construction costs;
(c)Comments from the State Historical Preservation Office or the Tribal Historical Preservation Office for construction projects;
(d)An independent third-party appraisal if the proposed project is to purchase real property;
(e)A work plan if the proposed project is for a revolving loan fund;
(f)Written commitments for supplemental funding;
(g)Letters of interest or commitment from small businesses needing assistance, if applicable;
(h)Small business certification, if applicable;
(i)Letters of interest or commitment from local employers, schools, training facilities, etc. to show the need of employment or job advancement opportunities for adult students, if applicable;
(j)A copy of the local or regional plan in which the proposed project is identified;
(k)Form RD 400-1, “Equal Opportunity Agreement” if the proposed project includes construction;
(l)Form RD 400-4, “Assurance Agreement';
(m)Form AD 1049, “Certification Regarding Drug-Free Workplace Requirements”;
(n)Form AD 1047, “Certification Regarding Debarment, Suspension, and Other Responsibility Matters—Primary Covered Transactions”;
(o)RD Instruction 1940-Q, Exhibit A-1, “Certification for Contracts, Grants and Loans (Lobbying Activities)” if the grant request is over $100,000; and
(p)SF-LLL, “Disclosure of Lobbying Activities,” if the grant is over $100,000 and the applicant has made or has agreed to make any payments to influence a decision in connection with the specific project. § 4284.144 Revolving loan fund work plan requirements. If the grant will be used to create or add to a revolving loan fund, the requirements of this section must be met. The revolving loan fund plan governs the operation of the fund and must have sufficient detail to provide USDA Rural Development with a complete understanding of what will be accomplished. It must contain the following:
(a)Demonstrated need of the fund including identification of the proposed project in a local or regional plan and the accomplishments to be completed with the fund. This should include a list of eligible small businesses (based on letters of interest or commitments) that need loans with the anticipated amount needed, purpose, and number of jobs to be created and/or saved.
(b)Experience of the organization in operating a revolving loan fund;
(c)Marketing and outreach plan with specific timeframes to complete the proposed accomplishments of the fund;
(d)Key personnel involved in the operation of the fund and their specific responsibilities;
(e)Availability of other funds and their sources;
(f)Service area where the loans will be offered;
(g)Eligibility criteria, loan purposes, and loan limits of the fund;
(h)Proposed fees, loan interest rate, and loan terms and how they are determined. These charges should be sufficient to support the operating expenses of the fund;
(i)Proposed collateral requirements;
(j)Application review and loan committee approval process;
(k)A copy of your application that must include, at a minimum, a space for the name and address of the loan recipient; loan purpose; interest rate and terms; location, nature, and scope of the project being financed; other funding included in the project; type and lien priority of collateral; and jobs to be created and/or saved.
(l)Process to be followed if a loan applicant is rejected;
(m)Monitoring system for distribution of approved funds and loan recipient accomplishments;
(n)Monitoring system for financial and activity reports; and
(o)Any other information pertinent to the revolving loan fund. §§ 4284.145-4284.148 [Reserved] § 4284.149 Application selection.
(a)Pending the availability of sufficient funds, USDA Rural Development State Offices receive an allocation of funds under this subpart each fiscal year. State Offices use the scoring criteria as defined in § 4284.139 to select the highest-ranking applications until the state allocation has been depleted. State Offices set internal cut-off dates for receipt of preapplications and attempt to make the information public knowledge. However, it is recommended that applicants contact the State Office to find out the specific amounts available and funding deadlines for this program. Applicants will receive a Letter of Conditions for grant approval and instructions from the State Office if the application is selected for funding.
(b)The National Office generally holds a minimal amount of appropriated funds for a national reserve competition each fiscal year. State Offices that have depleted the state allocation are eligible to submit applications to the National Office for competition. Starting with the highest-ranking application received nationwide, the highest-ranking application per state is selected until the reserve is exhausted. This ensures USDA Rural Development is distributing funds on a geographical basis. If a tie exists in the competition, projects are selected based on viability of the projects in accordance with the funds available. State Offices will submit applications to the National Office for reserve competition. Applicants will receive a Letter of Conditions and instructions for grant approval from the USDA Rural Development State Office if the application is selected for funding. §§ 4284.150-4284.151 [Reserved] § 4284.152 Letter of Conditions. The Letter of Conditions establishes conditions that must be understood and agreed to by the applicant before any obligation of funds can occur. The applicant must sign a Form RD 1942-46, “Letter of Intent to Meet Conditions,” and a Form RD 1940-1, “Request for Obligation of Funds,” if they wish to accept the conditions of the grant. These forms will be enclosed with the Letter of Conditions. The grant will be obligated when the USDA Rural Development State Office receives an executed Letter of Intent and Request for Obligation of Funds from the applicant. § 4284.153 Grant Agreement. The applicant will also be required to sign a Form RD 4284-1, “Grant Agreement,” which is a contract between the grantee and USDA Rural Development for receipt of grant funds under the RBEG Program. The Grant Agreement will also be enclosed with the Letter of Conditions and must be signed and returned to the USDA Rural Development State Office before any grant funds can be disbursed. §§ 4284.154-4284.155 [Reserved] § 4284.156 Timeframe for use of grant funds. The grant period will be established in your Letter of Conditions for a 12-month timeframe unless USDA Rural Development approves the scope of work or work plan for a longer period of time. § 4284.157 Financial management system. The grantee will provide for a financial management system, which will include:
(a)Accurate, current, and complete disclosure of the financial result of each grant.
(b)Records that identify adequately the source and application of funds for grant-supporting activities, together with documentation to support the records. These records shall contain information pertaining to grant awards, authorizations, obligations, unobligated balances, assets, outlays, income and interest.
(c)Effective control over and accountability for all funds, property and other assets. Grantee shall adequately safeguard all such assets and assure that funds are used solely for authorized purposes. § 4284.158 Grant disbursement. Grant funds are disbursed on a reimbursement basis except if they are for revolving loan funds. Grant disbursement for revolving loan funds will be advanced. The financial management system of the grantee must provide for effective control and accountability of all funds. Grant funds may be requested as follows:
(a)*Reimbursement requests.* An SF-270, “Request for Advance or Reimbursement,” may be submitted to USDA Rural Development once every 30 days for reimbursement on allowable grant expenses. A pro rata portion of supplemental funds must be included in the request. An SF-271, “Outlay Report and Request for Reimbursement for Construction Programs,” or similar form may be submitted to USDA Rural Development once every 30 days on construction projects.
(b)*Advance requests.* An SF-270 may be submitted once every 30 days for an advance of funds. A pro rata portion of supplemental funds must be included in the request for an advance. Before any grant funds can be advanced, the grantee must submit information on each loan that they are proposing to make for review and concurrence by USDA Rural Development. The specific information required is defined in § 4284.184. Grantees must remit any interest earned on advanced grant funds. Interest should be forwarded to USDA Rural Development on a quarterly basis. §§ 4284.159-4284.160 [Reserved] § 4284.161 Insurance requirements.
(a)Fidelity bond coverage will be required on grantees that are nonprofit organizations. Coverage may be provided either for all individual positions or persons, or through blanket coverage that provides protection for all appropriate employees and officials. The amount of coverage will be at least equal to the maximum amount of monies that the grantee will have on hand at any one time. The grantee must renew fidelity bond coverage on a yearly basis if they are operating a revolving loan fund. There are no fidelity bond coverage requirements for a public body.
(b)Hazard insurance will be maintained by grantees whose project involves purchase or improvements to real property or purchase of machinery or equipment. In the case of a revolving loan fund, the loan recipient will be required to maintain hazard insurance with a standard mortgagee clause naming the grantee as beneficiary as long as a lien exists. The grantee's interest in the insurance will be assigned to USDA Rural Development, upon USDA Rural Development's request, in the event of termination of the revolving loan fund. The amount of coverage should be at least the lesser of the depreciated replacement value of the property being insured or the amount of the grant or loan. Hazard insurance includes fire, windstorm, lightning, hail, business interruption, explosion, riot, civil commotion, vehicle, marine, smoke, builder's risk, public liability, property damage, and any other hazard insurance that may be required to protect the property being insured or the grantee's security.
(c)Worker's compensation insurance will be required on the grantee and any recipient who receives a loan from a revolving loan fund in accordance with State law.
(d)Flood insurance will be required on grantees and loan recipients if their project is located in a special flood or mudslide hazard area. §§ 4284.162-4284.163 [Reserved] § 4284.164 Changes in scope of work, work plan or budget.
(a)Prior approval must be obtained from USDA Rural Development for any of the following changes to the approved project:
(1)Project scope or objectives;
(2)Need to extend the period of availability of funds;
(3)Change in key personnel as specified in the application;
(b)Prior approval must be obtained from USDA Rural Development for any of the following budget revisions:
(1)Transfer of amounts budgeted for indirect costs to absorb increases in direct costs, or vice versa;
(2)Transfer of amounts previously budgeted for training allowances to other categories of expense;
(3)Costs that require prior approval in accordance with the applicable OMB cost principles circulars; or
(4)Need for additional funds.
(c)Prior approval must be obtained from USDA Rural Development on projects that have both construction and nonconstruction activities before making any fund or budget transfer from the nonconstruction or construction budgets or vice versa.
(d)Prior approvals will not be valid unless they are in writing and approved by USDA Rural Development. Failure to obtain prior approval of changes to the approved project or budget may result in suspension or termination of grant funds. §§ 4284.165-4284.166 [Reserved] § 4284.167 Reporting requirements.
(a)*Project performance reports.* Grantees shall constantly monitor performance to ensure time schedules and other performance objectives are being achieved. A project performance report is not required for construction projects. On-site technical inspections and certified percentage-of-completion data will serve as the performance monitoring system for construction projects. This will be done in accordance with RD Instruction 1942-A, § 1942.18. A project performance report is required for all non-construction projects on a quarterly basis. The report is due 30 days after the end of the quarter. The final report can serve as the last quarterly report. The report should include the following:
(1)A comparison of actual accomplishments to the objectives established for that period;
(2)Reasons why established goals were not met;
(3)Any significant developments that would have an adverse or favorable affect on the overall project objectives. This notification must include a statement of the action taken or contemplated, and any assistance needed to resolve the situation;
(4)Objectives and timetables for the next reporting period; and
(5)Additional information on the final report as follows:
(i)Actual accomplishments as a result of the grant, i.e. number of jobs created, saved, and number of businesses assisted or other performance goals established in the scope of work.
(ii)What have been the most challenging or unexpected aspects of this program?
(iii)What advice would the grantee give to other organizations planning a similar program? These should include strengths and limitations of the program. If the grantee had the opportunity, what would they have done differently?
(iv)If an innovative approach was used successfully, the grantee should describe its program in detail so that other organizations might consider replication in their areas.
(b)*Financial reports.* The following financial reports will be required and are available in any USDA Rural Development State Office:
(1)*All projects.* An SF 269 or 269A, “Financial Status Report,” is required for all nonconstruction and construction projects on a quarterly basis. The report is due 30 days after the end of the quarter. SF 269A may be used by the grantee if there is no program income being generated in the project.
(2)*Additional revolving loan fund reports.* Grantees will also be required to submit a Form RD 1951-4, “Reporting of IRP/RDLF Lending Activity,” report on a quarterly basis until all of the grant funds have been loaned out to small businesses. The report is due 30 days after the end of the quarter. Thereafter, reports will be required semiannually 30 days after the end of the period.
(c)*Audits.* Grantees must provide an annual audit in accordance with 7 CFR part 3052. USDA Rural Development will inform the grantee of its auditing requirements. §§ 4284.168-4284.169 [Reserved] § 4284.170 Site visits.
(a)The grantee is responsible for managing the day-to-day operations of the project to ensure time schedules are met and that performance goals are achieved. However, USDA Rural Development will make site visits, as necessary, to assure compliance with applicable Federal requirements. After all grant funds have been disbursed for revolving loan fund, capital improvements or equipment purchase projects, a site visit will occur every 3 years until the project is transferred, terminated, disposed of, or has met its useful life term in accordance with the Grant Agreement.
(b)During the site visit the USDA Rural Development representative will perform and document due diligence if actual or potential site contamination by hazardous materials or petroleum products is observed on the site or adjacent sites. Due diligence documentation is necessary to assure USDA Rural Development maintains lender liability protection under the Comprehensive Environmental Response, Conservation and Liability Act (CERCLA).
(c)Site visits can include a civil rights compliance review; a physical inventory of any property purchased or improved with grant funds or equipment purchased with grant funds; a revolving loan fund review to ensure the fund is still operating in accordance with the work plan, if applicable; and other reviews as needed to ensure the project is in compliance with the Letter of Conditions and Grant Agreement. §§ 4284.171-4284.172 [Reserved] § 4284.173 Record retention. USDA Rural Development must have access to grantees records including financial, supporting documents, statistical or other records pertinent to the grant. Records must be retained for 3 years after the date of the final grant disbursement unless there is:
(a)Any litigation, claim, negotiation, audit or other action involving the records that have been started before the expiration date of the 3-year period. The records must be retained until completion of the action and resolution of all issues that arise from it or until the end of the regular 3-year period, whichever is later.
(b)Real property; equipment; and revolving loan fund project records. Records must be retained until transfer, termination, disposition, or replacement occurs or the useful life term has expired in accordance with the grant agreement. The 3-year retention period would start the date of transfer, termination, disposition, replacement or the date the useful life term has expired.
(c)Indirect cost rate proposals, cost allocation plans, etc. Records must be retained for 3 years from the date the proposal is submitted for negotiation. If the proposal is not required to be submitted for negotiation, then the 3-year retention period starts the end of the fiscal year covered by the proposal. §§ 4284.174-4284.177 [Reserved] § 4284.178 Disposition of real property, equipment, and supplies.
(a)If grant funds are used to acquire or improve real property, and if the property is sold or is no longer needed for any reason, USDA Rural Development will have an interest in the current fair market value of the property in proportion to its participation in the project. Installation or improvements to utilities or streets in the public right of way is considered improving the surrounding property or land owned by the grantee. USDA Rural Development also has the right to the current fair market value of that property in proportion to its participation in the project if that property is sold or not used for its originally approved purpose. The grantee may be required to file a Notice of Interest when grants funds are used to purchase or improve real property unless it is prohibited by State law.
(b)If grant funds are used to purchase equipment and the equipment is no longer needed for any reason, the grantee may retain, sell or otherwise dispose of the equipment with no further obligation to USDA Rural Development if the current fair market value of the equipment (per unit) is less than $5,000. However, if the current fair market value (per unit) is $5,000 or more USDA Rural Development has the right to an amount calculated by multiplying the current fair market value (per unit) if it is retained or proceeds from the sale if sold by the Federal share of the equipment.
(c)If the grant funds are used to purchase supplies and the grant is closed out, the grantee may keep unused supplies if the total aggregate fair market value of the supplies was less than $5,000. Otherwise, the grantee will compensate USDA Rural Development the current fair market value of the unused supplies to its participation. §§ 4284.179-4284.180 [Reserved] § 4284.181 Construction requirements. Section 1942.18 of this title will be followed in the planning and performance of construction projects. §§ 4284.182-4284.183 [Reserved] § 4284.184 Clarification of revolving loan fund operation. The following paragraphs will provide clarification on operating revolving loan funds under this subpart:
(a)A revolving loan fund must be operated on a long-standing basis and not duplicate services provided by an existing loan fund serving the same geographic area. It should not be established to assist one small business with a short-term working capital need and never have another loan made from it to assist other small businesses.
(b)A third-party with required experience can be hired to do the credit and financial analysis, but the grantee is still responsible for approving loans and managing the fund. USDA Rural Development will review and concur in any service agreement when this is the case before the grant is approved.
(c)Grantees are required to deposit grant funds and the 20 percent matching funds into a separate FDIC insured account. A control agreement will be executed to allow USDA Rural Development a security interest in the revolving loan fund deposit account as well as access to account information. The control agreement will also ensure that the deposit account/revolving loan fund will not be closed without prior approval of USDA Rural Development.
(d)Loans made from the revolving loan fund must be for purposes in accordance with the revolving loan fund work plan. However, the loan purposes are limited to the eligible purposes defined in paragraphs
(a)through
(c)of § 4284.109, working capital and debt refinancing.
(e)Loans made from the revolving loan fund must be economically feasible to ensure sustainability of the revolving loan fund.
(f)The receivables created by making loans from the fund, the grantee's security interest in collateral pledged by small businesses, collections on the receivables, interest, fees, and any other income from the operation of the revolving loan fund are considered to be part of the revolving loan fund.
(g)All debt instruments and collateral documents used by the grantee in connection with making loans from the fund must be assignable. Security for a loan from the revolving loan fund to a third party will be negotiated between the grantee and the third party within the policies established in the work plan.
(h)USDA Rural Development will review and concur in each loan the grantee is proposing to make until all of the grant funds are expended. Eligibility, environmental concerns, and other issues necessary to ensure sustainability of the fund will be reviewed. The following will be required for each loan:
(1)A copy of the application;
(2)Loan Committee recommendation or write-up;
(3)Intergovernmental comments;
(4)Small business certification;
(5)Form RD 1940-20;
(6)Form AD 1048, “Certification of Debarment, Suspension, Ineligibility and Voluntary Exclusion—Lower Tier Covered Transactions;” and
(7)Form RD 400-4.
(i)USDA Rural Development loan review and concurrence will not be necessary once the grantee lends out an amount equal to the grant. However, the grantee must continue to operate the revolving loan fund in accordance with the work plan, collect civil rights data and obtain all required items defined in paragraphs (h)(1) through
(7)of this section for each loan made thereafter. USDA Rural Development will conduct a site visit at least every 3 years to ensure the grantee is complying with all Federal requirements and administering the fund in accordance with the work plan.
(j)Grantees may use principal and interest payments plus fee income received from their borrowers (revolved funds) for debt service, administrative expenses, or making additional loans.
(k)A reasonable amount of revolved funds should be used to create a reserve for bad debts. USDA Rural Development recommends a reserve for bad debts of 6 percent of outstanding loans, which can be accumulated over 3 years and should be maintained from then on.
(l)Grantees may also use up to a maximum of 20 percent of interest and fee income per fiscal year for the administrative costs associated with operating the revolving loan fund.
(m)Failure, inability or unwillingness of the grantee to carry out or comply with the work plan, grant agreement or any applicable Federal or State law is cause for termination. If the grant is terminated, USDA Rural Development takes control of the deposit account in which the fund is located, the pending note receivables and any security interest pledged on the pending note receivables. §§ 4284.185-4284.188 [Reserved] § 4284.189 Grant termination. The grant award can be terminated in the following situations:
(a)*Termination for cause.* If the grantee fails to comply with the conditions of the Letter of Conditions or the Grant Agreement, USDA Rural Development can terminate the grant. USDA Rural Development will notify the grantee in writing of the decision to terminate, including the reasons and the effective date of the grant termination.
(b)*Termination by mutual agreement.* The grantee must provide written notification to USDA Rural Development explaining the reasons why they wish to terminate the grant and the proposed effective date. If USDA Rural Development mutually agrees that the continuation of the project would not produce beneficial results the grant can be terminated.
(c)*Deobligation of grant funds.* USDA Rural Development will automatically deobligate grant funds if a project is not completed within 3 years from the date of obligation. § 4284.190 Transfer and assumptions. USDA Rural Development will not approve any transfer and assumptions on grants awarded under this subpart. §§ 4284.191-4284.193 [Reserved] § 4284.194 Appeal rights. The applicant or grantee may have review or appeal rights on adverse decisions made by USDA Rural Development. Written instructions will be provided to the applicant or grantee by USDA Rural Development when review or appeal rights are applicable in accordance with 7 CFR part 11. §§ 4284.195-4284.200 [Reserved] Dated: March 29, 2007. Thomas C. Dorr, Under Secretary, Rural Development. [FR Doc. 07-1922 Filed 4-19-07; 8:45 am]
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Traces to 29 documents
24 references not yet in our index
  • 21 CFR 520
  • 21 CFR 20
  • 5 USC 801-808
  • 21 CFR 522
  • 21 CFR 556
  • 21 CFR 558
  • 22 CFR 504
  • 5 CFR 2635.805
  • 340 U.S. 462
  • 22 CFR 503
  • 40 CFR 52
  • Pub. L. 104-4
  • 40 CFR 70
  • 40 CFR 70.10(b)
  • 87 F.3d 280
  • 40 CFR 70.6
  • 7 CFR 4284
  • 7 CFR 3015
  • 5 USC 601-602
  • 7 CFR 11
  • 7 CFR 1940
  • Pub. L. 91-190
  • 7 CFR 1942
  • 7 CFR 3052
Citation graph
cites case law
Rules and Regulations
Final rule
C.F.R.§ 520.447
C.F.R.§ 514.11
C.F.R.§ 25.33
U.S.C.§ 804
U.S.C.§ 360b
U.S.C.§ 553
C.F.R.§ 556.283
U.S.C.§ 360ccc–2
U.S.C.§ 342
SCOTUS340 U.S. 462
F. App'x87 F.3d 280
Cite21 CFR 520
Cites 53 · showing 12Cited by 0 across 0 sources
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