Unknown. Final rule; correction
43,932 words·~200 min read·
/register/2007/07/26/07-3653A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
--- schema: federal-register doc_type: fedreg source_file: FR-2007-07-26.xml --- 72 143 Thursday, July 26, 2007 Contents Agricultural Agricultural Research Service PROPOSED RULES Practice and procedure: Research, education, and economics mission area; cooperative agreements; use, award, and administration, 41027-41042 E7-13550 Agriculture Agriculture Department See Agricultural Research Service See Farm Service Agency See Forest Service NOTICES Agency information collection activities; proposals, submissions, and approvals, 41049-41050 E7-14471 E7-14472 E7-14474 Census Census Bureau NOTICES Agency information collection activities; proposals, submissions, and approvals, 41054-41055 E7-14453 E7-14456 Centers Centers for Disease Control and Prevention NOTICES Agency information collection activities; proposals, submissions, and approvals, 41077-41080 E7-14432 E7-14439 Meetings:
Injury Prevention and Control Advisory Committee, 41080 E7-14430 Coast Guard Coast Guard RULES Regattas and marine parades: East Coast Boat Racing Club Power Boat Race, 41023-41025 E7-14401 Commerce Commerce Department See Census Bureau See Economic Development Administration See International Trade Administration See National Oceanic and Atmospheric Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 41053-41054 E7-14452 E7-14454 Comptroller Comptroller of the Currency NOTICES Agency information collection activities; proposals, submissions, and approvals, 41105 07-3650 Defense Defense Department See Defense Logistics Agency Defense Defense Logistics Agency NOTICES Privacy Act; systems of records; correction, 41107 C7-3558 Economic Economic Development Administration NOTICES Adjustment assistance; applications, determinations, etc.:
Rex Granite Co. Inc. et al., 41055-41056 07-3657 Education Education Department NOTICES Agency information collection activities; proposals, submissions, and approvals, 41065-41066 E7-14449 Employment Employment and Training Administration NOTICES Adjustment assistance; applications, determinations, etc.: Alcraft, 41085 E7-14414 Burlington House Pioneer Plant, 41085-41086 E7-14417 Continental Structural Plastics, 41086 E7-14420 Dana Corp., 41086 E7-14419 Gage Pattern Inc. et al., 41087-41088 E7-14416 Hoffman Industries, Inc., 41088-41089 E7-14421 International Business Machines Corp., 41089 E7-14418 Tyco Electronics Corp., 41089 E7-14422 Energy Energy Department See Energy Efficiency and Renewable Energy Office See Federal Energy Regulatory Commission Energy Energy Efficiency and Renewable Energy Office PROPOSED RULES Energy conservation:
Commercial and industrial equipment; energy efficiency program— Commercial ice-cream freezers, self-contained commercial refrigerators, freezers, and refrigerator-freezers without doors, etc.; standards; meeting, 41162-41210 07-3640 EPA Environmental Protection Agency RULES Air pollution control: State operating permits programs— New Jersey, 41025-41026 E7-14483 NOTICES Agency information collection activities; proposals, submissions, and approvals, 41070-41073 E7-14479 E7-14482 Air programs:
Applicability Determination Index Database System; agency applicability determinations, alternative monitoring decisions, etc.; postings, 41110-41125 E7-13894 Meetings: Human Studies Review Board, 41073-41074 E7-14468 Farm Farm Service Agency NOTICES Agency information collection activities; proposals, submissions, and approvals, 41051 E7-14385 FAA Federal Aviation Administration RULES Standard instrument approach procedures, 41009-41010 E7-14079 PROPOSED RULES Airworthiness directives:
Thrush Aircraft, Inc., 41042-41045 E7-14433 FCC Federal Communications Commission NOTICES Meetings: Diversity for Communications in the Digital Age Advisory Committee, 41074-41075 E7-14379 Federal Energy Federal Energy Regulatory Commission NOTICES Electric rate and corporate regulation combined filings, 41067-41069 E7-14413 Hydroelectric applications, 41069-41070 E7-14408 Meetings: Modesto and Turlock Irrigation Districts, CA; Don Pedro Project fisheries study plan, 41070 E7-14411 *Applications, hearings, determinations, etc.:* ANR Pipeline Co., 41066 E7-14412 Discovery Gas Transmission LLC, 41066-41067 E7-14410 MIGC, Inc., 41067 E7-14409 Federal Highway Federal Highway Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 41094-41095 E7-14404 Environmental statements; notice of intent:
Sarpy County, NE, 41096 07-3652 Federal agency actions on proposed highways; judicial review claims: Alaska highway projects, 41096-41097 07-3662 Bannock County, ID; Cheyenne Overpass project, 41097-41098 07-3645 Federal Labor Federal Labor Relations Authority NOTICES Senior Executive Service Performance Review Board; membership, 41075 E7-14443 Federal Reserve Federal Reserve System NOTICES Banks and bank holding companies: Change in bank control; correction, 41075 E7-14447 Formations, acquisitions, and mergers, 41075-41076 E7-14446 Fish Fish and Wildlife Service NOTICES Comprehensive conservation plans; availability, etc.:
Stone Lakes National Wildlife Refuge, CA, 41084 E7-14425 Food Food and Drug Administration RULES Animal drugs, feeds, and related products: Minor uses or minor species; new drugs designation, 41010-41022 E7-14444 NOTICES Reports and guidance documents; availability, etc.: Cell selection devices for point of care production of minimally manipulated autologous peripheral blood stem cells, 41080-41081 07-3659 In vitro diagnostic multivariate index assays, 41081-41083 07-3660 Medical products; emergency use authorization, 41083-41084 07-3661 Forest Forest Service NOTICES Environmental statements; notice of intent:
Clearwater National Forest, ID, 41051-41052 07-3653 Meetings: Resource Advisory Committees— Eastern Idaho, 41053 07-3654 Tehama County, 41053 07-3646 Health Health and Human Services Department See Centers for Disease Control and Prevention See Food and Drug Administration NOTICES Reports and guidance documents; availability, etc.: United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act— Grants, contracts, or cooperative agreements; award prohibition to organizations not having explicit policy opposing prostitution and sex trafficking, 41076-41077 07-3658 Homeland Homeland Security Department See Coast Guard Housing Housing and Urban Development Department RULES Public and Indian housing:
Indian Housing Block Grant Program; annual performance report due date extension, 41212-41213 E7-14478 Interior Interior Department See Fish and Wildlife Service IRS Internal Revenue Service RULES Income taxes: Tax-sheltered annuity contracts, 41128-41160 07-3649 Procedure and administration: Taxpayers who have participated in listed transactions or undisclosed reportable transactions; suspension provisions Correction, 41022 E7-14398 PROPOSED RULES Income taxes: Mortality tables for determining present value Correction, 41107 C7-2631 Procedure and administration:
Taxpayers filing timely income tax returns to whom IRS does not provide timely notice stating additional tax liability; suspension provisions Correction, 41045-41046 E7-14397 Taxpayers who have participated in listed transactions or undisclosed reportable transactions; suspension provisions; cross-reference Correction, 41045 E7-14400 NOTICES Meetings: Taxpayer Advocacy Panels, 41105-41106 E7-14388 E7-14390 E7-14393 E7-14394 International International Trade Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 41056-41057 E7-14458 Antidumping:
Frozen warmwater shrimp from— China, 41058-41061 E7-14461 Antidumping and countervailing duties: Administrative review requests, 41057-41058 E7-14459 Justice Justice Department NOTICES Pollution control; consent judgments: E. I. du Pont de Nemours & Co., 41085 07-3648 Labor Labor Department See Employment and Training Administration See Mine Safety and Health Administration Maritime Maritime Administration NOTICES Coastwise trade laws; administrative waivers: LAZZARONE, 41098-41099 E7-14434 SANCERRE, 41099 E7-14436 Meetings:
Voluntary Tanker Agreement; revisions, 41099-41103 E7-14534 Mine Mine Safety and Health Administration NOTICES Petitions for safety standards modification; application, processing, disposition, etc., 41089-41090 E7-14445 NOAA National Oceanic and Atmospheric Administration PROPOSED RULES Fishery conservation and management: Caribbean, Gulf, and South Atlantic fisheries— Gulf of Mexico shrimp and reef fish, 41046-41047 E7-14450 Northeastern United States fisheries— Northeast Region standardized bycatch reporting methodology omnibus amendment, 41047-41048 E7-14455 NOTICES Agency information collection activities; proposals, submissions, and approvals, 41061-41063 E7-14460 E7-14463 E7-14464 Coastal zone management programs and estuarine sanctuaries:
Wells, Maine, National Estuarine Research Reserve; management plan, 41063 E7-14487 Environmental statements; notice of intent: Caribbean, Gulf, and South Atlantic fisheries— Spiny lobster, 41063-41064 E7-14451 Marine mammal permit applications, determinations, etc., 41064-41065 E7-14457 Meetings: New England Fishery Management Council, 41065 E7-14387 National Science National Science Foundation NOTICES Meetings; Sunshine Act, 41090 E7-14523 Nuclear Nuclear Regulatory Commission RULES Fee schedules revision; 90% fee recovery (2007 FY) Correction, 41009 E7-14441 NOTICES Agency information collection activities; proposals, submissions, and approvals, 41091 E7-14438 Environmental statements; availability, etc.:
NSF International, 41091-41092 07-3666 Meetings; Sunshine Act, 41092-41093 07-3676 SEC Securities and Exchange Commission NOTICES Self-regulatory organizations; proposed rule changes: NASDAQ Stock Market LLC, 41093-41094 E7-14386 Transportation Transportation Department See Federal Aviation Administration See Federal Highway Administration See Maritime Administration Treasury Treasury Department See Comptroller of the Currency See Internal Revenue Service NOTICES Agency information collection activities; proposals, submissions, and approvals, 41103-41105 E7-14462 E7-14467 E7-14470 Separate Parts In This Issue Part II Environmental Protection Agency, 41110-41125 E7-13894 Part III Treasury Department, Internal Revenue Service, 41128-41160 07-3649 Part IV Energy Department, Energy Efficiency and Renewable Energy Office, 41162-41210 07-3640 Part V Housing and Urban Development Department, 41212-41213 E7-14478 Reader Aids Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions. 72 143 Thursday, July 26, 2007 Rules and Regulations NUCLEAR REGULATORY COMMISSION 10 CFR Part 171 RIN 3150-AI00 Revision of Fee Schedules; Fee Recovery for FY 2007; Correction AGENCY: U.S. Nuclear Regulatory Commission. ACTION:
Final rule; correction. SUMMARY: This document corrects a final rulemaking published on June 6, 2007 (72 FR 31401), that amends the licensing, inspection, and annual fees charged to its applicants and licensees. This notice is necessary to correct an erroneous amendatory instruction. DATES: *Effective Date:* August 6, 2007. FOR FURTHER INFORMATION CONTACT: Renu Suri, Office of the Chief Financial Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Telephone 301-415-0161, e-mail *RXS6@nrc.gov* .
SUPPLEMENTARY INFORMATION: PART 171—[CORRECTED] § 171.16 [Corrected] On page 31427, in the third column, amendatory instruction 10. is corrected to read, “In 171.16, paragraph (a)(2) is redesignated as paragraph (a)(3) and revised, a new paragraph (a)(2) is added, and paragraphs (c), (d), and
(e)are revised to read as follows:” Dated at Rockville, Maryland, this 20th day of July, 2007. For the Nuclear Regulatory Commission. Cindy Bladey, Acting Chief, Rulemaking, Directives, and Editing Branch, Division of Administrative Services, Office of Administration. [FR Doc. E7-14441 Filed 7-25-07; 8:45 am] BILLING CODE 7590-01-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 97 [Docket No. 30561; Amdt. No. 3228] Standard Instrument Approach Procedures; Miscellaneous Amendments AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Final rule. SUMMARY: This amendment amends Standard Instrument Approach Procedures (SIAPs) for operations at certain airports. These regulatory actions are needed because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, addition of new obstacles, or changes in air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports. DATES: This rule is effective July 26, 2007. The compliance date for each SIAP is specified in the amendatory provisions. The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of July 26, 2007. ADDRESSES: Availability of matter incorporated by reference in the amendment is as follows: *For Examination—* 1. FAA Rules Docket, FAA Headquarters Building, 800 Independence Ave., SW., Washington, DC 20591; 2. The FAA Regional Office of the region in which affected airport is located; or 3. The National Flight Procedures Office, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 or, 4. The National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: *http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html* . *For Purchase—* Individual SIAP copies may be obtained from: 1. FAA Public Inquiry Center (APA-200), FAA Headquarters Building, 800 Independence Avenue, SW., Washington, DC 20591; or 2. The FAA Regional Office of the region in which the affected airport is located. *By Subscription—* Copies of all SIAPs, mailed once every 2 weeks, are for sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402. FOR FURTHER INFORMATION CONTACT: Donald P. Pate, Flight Procedure Standards Branch (AFS-420), Flight Technologies and Programs Division, Flight Standards Service, Federal Aviation Administration, Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd. Oklahoma City, OK 73169 (Mail Address: P.O. Box 25082 Oklahoma City, OK 73125) telephone:
(405)954-4164. SUPPLEMENTARY INFORMATION: This amendment to Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) amends Standard Instrument Approach Procedures (SIAPs). The complete regulatory description of each SIAP is contained in the appropriate FAA Form 8260, as modified by the National Flight Data Center (FDC)/Permanent Notice to Airmen (P-NOTAM), which is incorporated by reference in the amendment under 5 U.S.C. 552(a), 1 CFR part 51, and § 97.20 of the Code of Federal Regulations. Materials incorporated by reference are available for examination or purchase as stated above. The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the **Federal Register** expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, but refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP contained in FAA form documents is unnecessary. The provisions of this amendment state the affected CFR sections, with the types and effective dates of the SIAPs. This amendment also identifies the airport, its location, the procedure identification and the amendment number. The Rule This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP as modified by FDC/P-NOTAMs. The SIAPs, as modified by FDC P-NOTAM, and contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these chart changes to SIAPs, the TERPS criteria were applied to only these specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a FDC NOTAM as an emergency action of immediate flight safety relating directly to published aeronautical charts. The circumstances which created the need for all these SIAP amendments requires making them effective in less than 30 days. Further, the SIAPs contained in this amendment are based on the criteria contained in TERPS. Because of the close and immediate relationship between these SIAPs and safety in air commerce, I find that notice and public procedure before adopting these SIAPs are impracticable and contrary to the public interest and, where applicable, that good cause exists for making these SIAPs effective in less than 30 days. Conclusion The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) Is not a “significant regulatory action” under Executive Order 12866;
(2)is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and
(3)does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. List of Subjects in 14 CFR Part 97 Air Traffic Control, Airports, Incorporation by reference, and Navigation (Air). Issued in Washington, DC on July 13, 2007. James J. Ballough, Director, Flight Standards Service. Adoption of the Amendment Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal Regulations, Part 97, 14 CFR part 97, is amended by amending Standard Instrument Approach Procedures, effective at 0901 UTC on the dates specified, as follows: PART 97—STANDARD INSTRUMENT APPROACH PROCEDURES 1. The authority citation for part 97 continues to read as follows: Authority: 49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721-44722. 2. Part 97 is amended to read as follows: §§ 97.23, 97.25, 97.27, 97.29, 97.31, 97.33, 97.35, and 97.37 [Amended] By amending: § 97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or TACAN; § 97.25 LOC, LOC/DME, LDA, LDA/DME, LDA w/GS, SDF, SDF/DME; § 97.27 NDB, NDB/DME; § 97.29 ILS, MLS, TLS, GLS, WAAS PA, MLS/RNAV; § 97.31 RADAR SIAPs; § 97.33 RNAV SIAPs; § 97.35 COPTER SIAPs, § 97.37 Takeoff Minima and Obstacle Departure Procedures. Identified as follows: Effective Upon Publication FDC date State City Airport FDC No. Subject 07/05/07 IN NEW CASTLE NEW CASTLE—HENRY CO MUNI 7/7352 NDB OR GPS RWY 9, AMDT 5. 07/11/07 AR FORT SMITH FORT SMITH REGIONAL 7/7963 ILS RWY 25, AMDT 21A. [FR Doc. E7-14079 Filed 7-25-07; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 20, 510, 514, and 516 [Docket No. 2005N-0329] RIN 0910-AF60 Designation of New Animal Drugs for Minor Uses or Minor Species AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Minor Use and Minor Species Animal Health Act of 2004 (MUMS act) amended the Federal Food, Drug, and Cosmetic Act (the act) to establish new regulatory procedures that provide incentives intended to make more drugs legally available to veterinarians and animal owners for the treatment of minor animal species and uncommon diseases in major animal species. At this time, FDA is issuing final regulations to implement the act. These regulations describe the procedures for designating a new animal drug as a minor use or minor species drug. Such designation establishes eligibility for the incentives provided by the MUMS act. DATES: This rule is effective October 9, 2007. FOR FURTHER INFORMATION CONTACT: Bernadette Dunham, Center for Veterinary Medicine (HFV-50), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9090, e-mail: *Bernadette.Dunham@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: I. Background In enacting the MUMS act (Public Law 108-282), Congress sought to encourage the development of animal drugs that are currently unavailable to minor species (species other than cattle, horses, swine, chickens, turkeys, dogs, and cats) in the United States or to major species afflicted with uncommon diseases or conditions (minor uses). Congress recognized that the markets for drugs intended to treat these species, diseases, or conditions are often so small that there are insufficient economic incentives to motivate sponsors to develop data to support approvals. Further, Congress recognized that some minor species populations are too small or their management systems too diverse to make it practical to conduct traditional studies to demonstrate safety and effectiveness of these animal drugs. As a result of these limitations, sponsors have generally not been willing or able to collect data to support legal marketing of drugs for these species, diseases, or conditions. Consequently, Congress enacted the MUMS act, which amended the Federal Food, Drug, and Cosmetic Act (the act) to provide incentives to develop new animal drugs for minor species and minor uses, while still ensuring appropriate safeguards for animal and human health. In the **Federal Register** of September 27, 2005 (70 FR 56394), FDA issued proposed regulations to implement section 573 of the act (21 U.S.C. 360ccc-2). These regulations proposed procedures for designating a new animal drug as a minor use or minor species drug. Such designation provides eligibility for certain incentives established by the MUMS act, including exclusive marketing rights associated with the conditional approval or approval of designated new animal drugs and for grants to support designated new animal drug development. The proposed rule initially provided for a 75-day public comment period during which the agency received several comments asserting that 75 days was not an adequate amount of time to prepare and submit meaningful comments. In response to this, in the **Federal Register** of December 28, 2005 (70 FR 76732), FDA reopened the comment period allowing an additional 30 days of public comment. II. Changes to the Proposed Rule In response to public comment, or in two places to provide added clarity, FDA has made the following changes to the proposed rule: § 516.3 *Definitions* . The definition of “ *Infrequently* ” was changed by adding the words “on an annualized basis” to the end of the proposed definition. The definition now reads: “ *Infrequently* , as used in the minor use definition, means a disease or condition that is uncommon or that occurs only sporadically on an annualized basis.” § 516.21 *Documentation of minor use status* . The language in § 516.21(b) was revised for clarity. § 516.28 *Publication of MUMS-drug designations* . In § 516.28(b), the term “generic name” was changed to “established name” to avoid confusion with abbreviated applications approved under section 512(b)(2) of the act. § 516.31 *Scope of MUMS-drug exclusive marketing rights* . In § 516.31(a)(2), the words “or proposes to withdraw” were removed. III. Comments The agency received comments from 9 organizations or individuals on the September 27, 2005, proposal. Comments were received from a trade organization representing new animal drug manufacturers, a trade organization representing pet product manufacturers, an animal feed manufacturer, a professional association representing veterinarians, an association representing zoos and aquariums, a consumer advocacy organization, and 3 consumers. A. Comments on the Proposed Rule (Comment 1) In § 516.3(b) one comment stated that for added clarity and consistency we should add the words “on an annualized basis” to the end of the definition for infrequently. (Response) We agree. We explained in the preamble to the proposed rule why we thought that it was appropriate to annualize the data on the number of animals in which the indication occurs (see 70 FR at 56395 to 56396). Therefore, we have revised the codified section accordingly. (Comment 2) Two comments stated that the requirement for a specific product development plan as part of a request for MUMS-drug designation in § 516.20(b)(6) is unnecessarily arduous and premature in the designation process. Commentors also stated that frivolous requests for designation should not be burdensome to the agency; and, therefore, that the requirement for a specific product development plan is unnecessary. (Response) We do not agree that the requirement for submission of a description of the product development plan is arduous or premature. Also, the basis for this requirement is not primarily to reduce burden on the agency due to frivolous requests for designation. The primary reasons for requiring a specific product development plan as part of a request for MUMS-drug designation are as follows. As we explained in the preamble to the proposed rule (70 FR 56394 at 56399), for new animal drugs, unlike for human orphan drugs, each designation must be unique with respect to drug, dosage form, and intended use. In this way, the MUMS act, which was enacted to address the critical shortage of approved animal drugs for minor species/minor uses, facilitates the development of a broad range of animal drugs in part by discouraging multiple sponsors from pursuing identical uses. Because each MUMS designation is unique, it is important to the effective implementation of section 573 of the act that initial designation of a drug be based on evidence that requesting sponsors clearly understand their responsibilities in terms of drug research and development and are prepared to accept those responsibilities. Submission of a description of the product development plan helps to ensure that timely development of the drug, consistent with the requirement of section 573(a)(2)(B) to actively pursue approval with due diligence, is feasible. Designation of a drug that could not feasibly be approved under the sponsor's current drug development plan would inappropriately delay development and marketing of a needed drug by the same or a different sponsor and undermine the goals of the MUMS act. Submitting the description of the product development plan also facilitates meaningful communication between the sponsor and the agency to help ensure that safety and effectiveness testing, which for designated drugs may be supported by grants or contracts under section 573(b) of the act, is efficiently designed and conducted. Efficient and effective use of sponsor and agency resources, which is enabled by this and other requirements of final § 516.20, is critically important to alleviating the shortage of new animal drugs addressed by the MUMS act. (Comment 3) Two comments stated that the documentation requirements for minor use status in § 516.21 are too burdensome. They believe there is a lack of balance between the documentation required for a minor use designation versus a minor species designation. More specifically, both commentors believe that § 516.21(b) is asking sponsors to prove a negative concerning the lack of medical justification and one of these commentors stated that the financial information requested in § 516.21(c) is, for the most part, confidential. As an alternative approach, these two commentors submitted similar two-part working definitions for minor use that could be used in place of the proposed provisions for § 516.21 as follows: Either: 1. The drug is not currently approved, it is unlikely the “minor use” designation for the drug will be applicable to a majority of the major species population, and the need for the drug for a specific disease or condition has been clearly identified by animal health professionals or an animal industry. One commentor also added a fourth provision that if the drug has the same active ingredient as other approved drugs, the environmental safety assessment of the combined active ingredient of all such drugs is shown to be adequate. Or; 2. The annualized commercial return on investment for the product is not reasonably expected to exceed the development and maintenance costs of the product. (Response) We do not agree that the requirements for documentation of minor use status in § 516.21 are too burdensome. FDA agrees that these implementing regulations should not be overly burdensome to drug sponsors in order to achieve the objectives set forth in the MUMS Act. However, it is unavoidable that a certain amount of additional information will be required in a request for minor use designation that will not be required in a request for minor species designation. Section 516.21 describes this additional information and comprises three paragraphs. Section 516.21(a) asks for an estimate of the total number of animals to which a drug could potentially be administered on an annual basis. Whether compared to a predetermined small number of animals or as part of a case-by-case determination, this number will be essential to any request for minor use designation. Simply put, this estimated number of animals serves as documentation that the intended use of a proposed MUMS drug is limited to a “small number of animals”, as required by the MUMS Act. Section 516.21(b) describes how to define a minor use population if the proposed MUMS drug is under development for only a subset of the estimated total number of animals to which the drug could potentially be administered on an annual basis. In this situation, a sponsor may utilize the provisions of this paragraph to argue that administration of a proposed MUMS drug is only justified for a small subset of a larger major species population potentially affected by a particular disease or condition and that administration to the remaining larger affected population is medically inappropriate. If the number of animals in this medically justified subset is a small number of animals, then such a use is a minor use. The provisions in this paragraph were apparently misinterpreted by two of the commentors. Its purpose is not to require medical justification to the effect that a drug approved for disease A could not be used for disease B or C or D. Its purpose is to allow drug sponsors to restrict the intended use of a drug to a subset of the animals affected by disease A, thereby reducing their estimate of the total number of animals eligible to be treated as required in § 516.21(a), by providing medical justification that only a subset of animals afflicted with disease A are amenable to treatment. For improved clarity, we have revised the language of § 516.21(b). Section 516.21(c) requires drug sponsors to provide economic information relevant to why their MUMS drug should be considered a minor use drug. In the preamble to the proposed MUMS designation rule (70 FR 56394) we cited the Senate report (S. Rept. 108-226) concerning the bill before the Senate (S. 741), which discusses the minor use definition and how minor use should be determined: “This definition incorporates the existing definition in the Code of Federal Regulations (21 CFR 514.1(d)(1)) with a further limitation to “small numbers” to assure that such intended uses will not be extended to a wider use. The Secretary is expected to further clarify this definition in regulations implementing this section. FDA is given broad latitude in determining what constitutes a minor use in a major species. The Congress intends for FDA to make the determination of minor use by evaluating, in the context of the drug development process, whether the incidence of the disease or condition occurs so infrequently that the sponsor of a drug intended for such use has no reasonable expectation of its sales generating sufficient revenues to offset the costs of development. The Congress does not intend for FDA to establish a test of commercial value, but rather directs FDA to determine whether the expected low use of a drug would discourage its development.” (S. Rept. 108-226 at 12-13.) In evaluating whether the incidence of the disease or condition is so infrequent that the sales are not reasonably expected to offset development costs, we might take two different approaches. First, we could consider each request on a case-by-case basis utilizing the information provided in § 516.21(c). Alternatively, we could establish, by regulation based on industry-wide economic data, a specific small number of animals for each of the seven major species to be used as a yardstick against which we would measure the estimated total number of animals to which a drug could potentially be administered on an annual basis, as documented under § 516.21(a). If such “small number” for each major species is established by regulation at some point in the future, there would no longer be a need for requiring the information requested in § 516.21(c). (Comment 4) With respect to § 516.24, two comments stated that FDA should respond to requests for designation within 60 days from the time the request was submitted. (Response) FDA agrees that timely processing of requests for designation is important. However, because of limitations on agency resources, the agency does not believe that it is feasible to commit to responding to all requests for designation within 60 days. We intend to issue guidance in the future to describe target timelines for the designation process consistent with current resources. (Comment 5) Two comments stated that FDA should update the publicly available list of MUMS-designated drugs within 60 days of granting a new MUMS designation. (Response) We agree that timely updating of the list of MUMS-designated drugs is appropriate. However, the agency does not believe it is feasible to commit to definite timelines in these regulations because of uncertain resource limitations. As discussed above, we intend to describe target timelines for our actions related to the designation process in future guidance. (Comment 6) Two comments stated that a 1-year advance notification for discontinuing the manufacture of a drug, as specified in § 516.29(b), is excessive and a 30-60 day timeframe would be more appropriate. (Response) A 1-year advance notification for discontinuing the manufacture of a MUMS-designated drug is required by section 573(a)(2)(C) of the act and, therefore, is not subject to alteration by regulation. (Comment 7) One commentor requested clarification on the hypothetical situation in which FDA has withdrawn designation status after notification by a sponsor (sponsor A) of its intent to discontinue production, but the drug is still being sold, as permitted in accordance with the lengthy pre-notification required by the statute. The commentor asked if another sponsor (sponsor B) could potentially achieve designation and conditional approval, and thus block any further sale by sponsor A, even if sponsor A still has time left on their notification and still has drug to be sold. (Response) In this situation, FDA has only withdrawn sponsor A's designation and, therefore, its exclusivity. The approval or conditional approval remains intact. Therefore, while approval or conditional approval may be possible for sponsor B, designation cannot be granted for sponsor B because the MUMS Act only allows designation when a specific drug, dosage form, and intended use is not already approved or conditionally approved. (Comment 8) In § 516.31(a)(2) one comment stated that the words § or proposes to withdraw” should be removed because this appears to negate the right of the sponsor to due process. (Response) We agree that the exclusivity of an approved or conditionally approved MUMS-designated drug should not be abrogated by a proposal to withdraw the approval or conditional approval. We have revised the codified section accordingly. (Comment 9) One comment stated that oral dosage form new animal drugs and new animal drugs for use in animal feeds should not be considered two different dosage forms for the purpose of MUMS designation. It argues, for example, that if an oral dosage form new animal drug is designated and approved subsequent to the designation and approval of a medicated feed containing the same drug and for the same intended use, it will negatively impact the business case and success of the medicated feed. (Response) The agency believes that this same argument could apply to any drug that is available in more than one dosage form. For example, an approved injectable product could be negatively impacted by approval of an oral form of the drug. As stated in the preamble to the proposed rule (70 FR 56394 at 56398), current federal regulations recognize the following dosage forms: Oral dosage forms (21 CFR part 520), implantation or injectable dosage forms (21 CFR part 522), ophthalmic and topical dosage forms (21 CFR part 524), intramammary dosage forms (21 CFR part 526), miscellaneous dosage forms (21 CFR part 529), and drugs in animal feeds (21 CFR part 558). The preamble also notes that medicated feeds are subject to different limitations from those for other oral dosage forms (70 FR 56394 at 56398), which also supports treating medicated feeds as a different dosage form for the purpose of MUMS designation. In addition, the markets for medicated feeds and other oral dosage forms may be different. An oral dosage in the form of a drench or a water treatment may be appropriate in different settings than those requiring treatment through the use of medicated feeds. For example, pheasants in a hatchery setting can be treated with medicated water while those in large outdoor pens are more efficiently treated with medicated feeds. Because the populations served by medicated feeds and by other oral dosage forms can be different enough to represent separate markets and because, as already noted, the same potential overlap can occur between any two dosage forms, we believe it is appropriate to treat medicated feeds and other oral dosage forms as different for MUMS designation purposes. (Comment 10) In the definition section under § 516.13, under *Intended Use* , one comment asked if treatment, control, and prevention are the same thing (i.e., one designation) or are they three different things (i.e., three possible designations). (Response) Given that requirements for approval may differ significantly for these three categories, they are considered to be different for purposes of designation. (Comment 11) One comment disagreed with the third principle of sameness discussed in the preamble to the proposed rule, under which an intended use for a disease or condition caused by one organism is considered different from an intended use for the same disease or condition caused by a different organism. The comment perceived this approach to determining sameness to be a disincentive to seeking MUMS designation. (Response) This comment raises the general issue of how different intended uses must be to be considered separate intended uses. If the uses are clearly separable and have different data requirements for approval, we believe it is appropriate to permit separate MUMS-drug designations. Intended uses for diseases or conditions caused by different organisms are clearly separable and would need to be supported by different data for approval; therefore, we believe that allowing separate MUMS-drug designations for drugs for such uses would be appropriate. (Comment 12) One comment was concerned that many zoo animals may be included in the broad major species categories. It stated that FDA should specifically identify the species and subspecies that are considered “major species” with the recognition that some species/subspecies may be appropriate only for public display or exhibition, and that these non-domestic animals should be identified separately for appropriate drug approval under MUMS regulations. (Response) Zoo species will not be lumped with major species for the purposes of drug approval. The major species are the domesticated species only, not including hybrids or closely-related wild species. Whether an animal belongs to a major or minor species is not affected by its location or use; it is strictly a matter of the species. Currently, FDA considers the major species to be: Cattle— *Bos taurus taurus* / *Bos taurus indicus* Horses— *Equus caballus* Swine— *Sus domesticus* Dogs— *Canis familiaris* (also called *Canis lupus familiaris* ) Cats— *Felis domesticus* (also called *Felis catus* or *Felis silvestris catus* ) Chickens— *Gallus gallus* Turkeys— *Meleagris gallopavo gallopavo* All other species are considered to be minor. Therefore, there should be no cause for concern regarding the status of zoo animals in terms of new animal drug approval. The agency intends to clarify this issue in guidance to be published in the future. (Comment 13) One comment stated that a manufacturer of a drug that is already approved in countries with substantially the same approval requirements as the United States does not need incentives to develop data and should not be given a MUMS designation. (Response) The MUMS incentives exist to encourage pharmaceutical companies to pursue approval of new animal drugs for minor uses and minor species. Even in cases where foreign approvals exist, sponsors generally need to provide considerable new data to meet the requirements for FDA approval. Therefore, the MUMS incentives remain appropriate when a drug has been approved in a foreign country. (Comment 14) One comment stated that in order to monitor whether the MUMS rule is fulfilling its intended goal to increase the availability of drugs for minor uses, FDA should require annual reports on quantities sold of each designated and conditionally approved drug. (Response) The agency agrees that knowledge of the quantity of designated drugs distributed on an annual basis would be useful information in terms of assessing the success of the MUMS act. The MUMS act itself requires the annual submission of information regarding quantities of conditionally approved products distributed (see 21 U.S.C. 360ccc(d)(2)(B)(ii)). All fully approved new animal drugs are required by regulation (21 CFR 514.80 (b)(4)(i)) to report the quantity of product distributed. The Office of Minor Use and Minor Species Animal Drug Development will have direct access to this information. B. Comments on “Small Number of Animals” and Minor Use (Comment 15) Three comments stated that companion animal “small numbers” should be considered separately from food animal “small numbers.” Two comments asked FDA to consider the numbers of animals eligible to be designated under a minor species provision (e.g., sheep) as a benchmark against which to compare numbers of animals to benefit from minor use provisions. (Response) The agency agrees that the “small numbers” for companion animals need to be considered separately from the “small numbers” for food animals. FDA also agrees that it is appropriate to consider the relationship between the number of animals of a minor species permitted to be designated under the MUMS act and the number of animals of a major species permitted to be designated in establishing “small numbers” of animals under the definition of minor use in the statute. However, the agency views the primary basis for establishing “small numbers” to be Congress' expression of intent in the report language accompanying the act that the agency further define minor use in a major species “by evaluating, in the context of the drug development process, whether the incidence of the disease or condition occurs so infrequently that the sponsor of a drug intended for such use has no reasonable expectation of its sales generating sufficient revenues to offset the cost of development” (S. Rept. 108-226 at 12-13). Since Congress provided incentives in the MUMS act to stimulate drug development, the agency interprets the previous statement to mean that FDA should determine for each major species what the “small number of animals” eligible to be treated on an annual basis would need to be in order to represent a drug market value that (relative to drug development costs) would be considerably less likely to be pursued in the absence of the MUMS incentives, than in their presence. (Comment 16) Two comments stated that “small numbers” should be based on epidemiological data and not on a percentage of the total major species population. Commentors stated that since such epidemiological data are not yet available, FDA should make minor use designations on a case-by-case basis rather than setting hard numbers. (Response) In the preamble to the proposed rule for MUMS designation (70 FR 56394), the agency already rejected the idea of establishing “small numbers” based on a percentage of the major species population as overly simplistic. There the agency explained that using the human orphan drug prevalence limit of 200,000 cases (0.1% of the U.S. population in 1983) did not seem helpful for calculating “small numbers” in cattle, swine, chickens, and turkeys because the populations involved, the manner of drug use in those populations, and the drug development processes for those species are too dissimilar to the human drug scenario (70 FR 56394 at 56396). Further analysis made clear that these factors were not sufficiently comparable for this approach to be viable, even for dogs, cats, and horses (70 FR 56394 at 56396). On the other hand, as already noted, Congress directed the agency to define “minor use” and, by extension, “small numbers,” on the basis of determining whether a population of animals of a major species needing drug treatment would provide sufficient drug market value to offset the cost of drug development given the incentives provided by the MUMS act. The use of epidemiological data comes into play at the point that the sponsor and the agency are trying to establish the population of animals eligible to be treated with a particular drug for a particular intended use. Such data need to be shared with the agency whether the determination of minor use is being made on a case-by-case basis or with respect to an established small number of animals. (Comment 17) One comment stated that FDA should consider the potential of a drug to be used extralabel when making a minor use designation. (Response) The agency understands the expressed concern regarding extra-label drug use, but extra-label drug use is an issue that clearly transcends the designation process. Extra-label use of approved new animal drugs is statutorily permissible under specified circumstances. (Extra-label use is not permitted for either conditionally approved or indexed drugs because such drugs have not met the full approval requirements of the statute.) There is no general prohibition regarding the extra-label use in minor species of products approved for use in major species or vice versa. Therefore, under designation, a product designated and approved for a minor species can be legally used in an extra-label manner in a major species (subject to established statutory and regulatory conditions). The same is true for a product designated for a minor use in a major species. It is difficult enough to determine whether the population of animals associated with the disease or condition for which a drug is labeled for use fails to provide sufficient market value to offset the cost of drug development (or falls above or below an established small number of animals). It would be impossible to determine the population of all animals subject to all potential extra-label uses of a drug. In fact, it must be assumed that this population (which may include all potential uses of a drug in all animal species) would very often exceed a small number of animals. Therefore, consideration of potential extra-label use in the designation process would have the effect of essentially negating the designation provision of the statute and this would clearly be contrary to the intent of the legislation. (Comment 18) One comment stated that long term use of a drug, even in a small number of animals, would constitute a much larger market than for shorter term use and that FDA should not consider animal numbers as “small” if food animals are to receive drugs for a long duration, perhaps for a period longer than 21 days, consistent with FDA's Guidance for Industry
(GFI)#152. (Response) As noted previously, the agency acknowledges the concern regarding the use of drugs in food animals and accepts that the concept of “small numbers” of animals included in the statutory definition of minor use is based, in part, on this concern. The agency will address the issue of establishing “small numbers” of animals for each major species in future rulemaking. However, a full assessment of the relative risks of individual drugs or drug uses is a matter that must be left to the comprehensive analysis associated with the review of individual new animal drug applications consistent with GFI #152 and other applicable policies and regulatory requirements. IV. Legal Authority FDA's authority for issuing this final rule is provided by the MUMS act (21 U.S.C. 360ccc *et seq.* ). When Congress passed the MUMS act, it directed FDA to publish implementing regulations (see 21 U.S.C. 360ccc note). In the context of the MUMS act, the statutory requirements of section 573 of the act, along with section 701(a) of the act (21 U.S.C. 371(a)) provide authority for this final rule. Section 701(a) authorizes the agency to issue regulations for the efficient enforcement of the act. V. Analysis of Economic Impacts FDA has examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this final rule is not a significant regulatory action under the Executive order. FDA finds that the final rule does not constitute an economically significant regulatory action as defined in section 3(f)(1) of Executive Order 12866. We believe that the annual impacts will not exceed $100 million since by its very nature the rule applies to animal drugs that have a very small market. Similarly, the administrative costs are unlikely to have a significant economic impact on a substantial number of small entities. Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $122 million, using the most current
(2005)Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount. FDA received nine comments to the proposed rule. Only two of these comments contained any remarks that addressed the impacts analysis of the proposed rule. Both stated that the requirement for a specific development plan before a designation is granted would be too burdensome. Neither of the comments provided any estimates on the size of the burden that would be imposed. FDA responded previously in this preamble to the burden issue in these comments. Further, FDA believes that the development of the plan would not be overly burdensome because, in most cases, it would be the same plan that a sponsor would establish with FDA under the regular animal drug review process, and because its cost, estimated at less than one thousand dollars each, would represent less than 0.1% of revenues of even the smallest establishments. Additionally, the MUMS act requires that FDA measure the diligence with which sponsors work towards final approval of a MUMS-designated drug, and a drug development plan is necessary for FDA to measure a sponsor's progress towards this goal. FDA has therefore not changed this provision in the final rule. None of the changes made to the final rule would affect the expected impacts of the rule on the animal drug producers. Accordingly, lacking any other comments to its analysis of the proposed rule, FDA has reviewed its impacts analysis published in the proposed rule and retains it here for the final rule. The intention of this rule, and therefore its benefit, is the creation of a system that would stimulate the development and marketing of animal drugs for rare diseases in major species and diseases found in minor species in the United States, which would otherwise not be economically viable under current market conditions. The countervailing cost, or risk of this final rule, would be the possibility of limited competition for approved drugs for a minor use drug indication or in a minor species drug due to the granting of the 7-year exclusive marketing right. In addition to the benefit-risk tradeoff mentioned previously, there would be additional administrative costs for those companies seeking the MUMS designation for a new animal drug application (NADA). We estimate that the designation request would require about 16 hours of preparation by a regulatory affairs official. At a benefit adjusted wage rate of almost $48 per hour for these employees, each request would have administrative costs of about $760. 1 We estimate that about 15 separate sponsors would each annually submit, on average, 5 MUMS designation requests. Administrative costs for these actions would total to about $57,300. 1 2000 National Industry-Specific Occupational Employment and Wage Estimates, U.S. Department of Labor, Bureau of Labor Statistics ( *www.bls.gov/oes/2000/oesi3_283.htm* ); Compliance officer wage rate adjusted to 2005 by 2000-20004 average annual wage inflator at BLS ( *http://data.bls.gov/cgi-bin/surveymost* ). The agency is also requiring in § 516.22 that foreign sponsors requesting designation do so through a permanent resident U.S. agent. This is consistent with the current requirements of 21 CFR 514.1(a) since requests for MUMS designation will ultimately be submitted to an NADA file. The agency does not expect to receive many requests for designation from foreign sponsors, and estimates that number at less than one per year. As such, the agency has not quantified the cost of this provision but believes it would be negligible. Amendments made to existing designations are expected to occur infrequently. We estimate that three amendments will be filed annually, requiring about two hours of preparation. At the same wage rate, this would cost an additional $300. Sponsors may also transfer sponsorship of MUMS-designated drug or terminate the designation. We estimate that these activities would result in only 3 additional hours of administrative costs annually, totaling to $150. The preparation of the annual report that would be required for each MUMS-designated drug is estimated to take about 2 hours. In the first year, this would result in another 150 hours of administrative costs, or about $7,200 in total. FDA notifications to sponsors concerning insufficient quantities of approved MUMS-designated drugs are expected to be rare, about once each year. Sponsor responses are estimated to take 3 hours, at a cost of $150. Assuming a sponsor chooses to seek the MUMS designation for its NADA, total administrative costs for this rule across all sponsors are estimated at about $65,000 in the first year, and to increase each year thereafter due to the annual reporting requirements. Regulatory Flexibility Analysis 1. Small Business Impacts The Regulatory Flexibility Act requires agencies to prepare a regulatory flexibility analysis if a rule is expected to have a significant economic impact on a substantial number of small entities. Although we believe it is unlikely that significant economic impacts would occur, the following along with other sections of this preamble constitute the regulatory flexibility analysis. One requirement of the Regulatory Flexibility Act is a succinct statement of any objectives of the rule. As stated previously in this analysis, with this rule the agency intends to create a system, provided for by statute, that would stimulate the development and marketing of animal drugs for rare diseases in major species and diseases found in minor species in the United States, which would otherwise not be economically viable under current market conditions. The Regulatory Flexibility Act also requires a description of the small entities that would be affected by the rule, and an estimate of the number of small entities to which the rule would apply. The Small Business Administration
(SBA)defines the criteria for small businesses using the North American Industrial Classification System (NAICS). For pharmaceutical preparation manufacturers (NAICS number 325412), SBA defines small businesses as those with less than 750 employees. Census data shows that 723 companies with 901 establishments represent this category. 2 While about two-thirds of the establishments would be considered small using the SBA criteria, the agency acknowledges that many requests for MUMS designation would likely be received from multi-establishment companies that exceed the 750-employee limit on small businesses. Nonetheless, the cost of submitting a single request represents only about 0.1% of the revenues of the smallest set of establishments (those with 1-4 employees), and much smaller revenue percentages of all larger establishments. The agency believes that these costs would not represent a significant economic impact on these firms. 2 2002 Economic Census, US Census Bureau, Manufacturing Industry Series, Pharmaceutical Preparation Manufacturing, Table 4. All of the costs described previously would be incurred by any small business that applies for MUMS designation. These include costs for request preparation, amendments to designations, preparing annual reports and responding to FDA notifications of insufficient quantities. The firms submitting requests for MUMS designation are expected to already have the necessary administrative personnel with the skills required to prepare the requests and fulfill reporting requirements as identified previously. 2. Analysis of Alternatives The Regulatory Flexibility Act requires that the agency consider any alternatives to a rule that would accomplish the objective while minimizing significant impacts of the rule. As stated previously, the agency believes that the final rule, due to the relatively small costs, would not be likely to impose significant economic impacts on small businesses. As such, the agency believes the final rule achieves the objective with minimal costs to industry. The statute that creates this system, Public Law 108-282, does not provide the agency a great deal of flexibility in the implementing regulations, such as in determining the length of the exclusivity period or granting an exclusivity to more than one animal drug without regard to sameness of drug, dosage form and intended use. The agency did consider, however, applying an explicit threshold number of animals of each major species as the upper bound of disease incidence in the definition of “minor use” of animal drugs. The agency determined that the data needed to develop these estimates would not be available in time for the publication date of the final rule as mandated by statute. The agency intends in the future to propose a separate rule defining the threshold numbers of animals of each major species. The agency will continue to consider the acceptability of each request for designation as a minor use animal drug on a case-by-case basis as provided for in the Senate report concerning the legislation, until it issues any final rule based on such a proposal. VI. Paperwork Reduction Act of 1995 In the **Federal Register** of September 27, 2005, FDA published a proposed rule and invited comments on the proposed collection of information. Also in a **Federal Register** of December 28, 2005, FDA published a notice reopening the comment period for the proposed rule to allow interested persons additional time to comment. Concurrently, FDA submitted the information collection request to the Office of Management and Budget
(OMB)for review and approval. OMB did not approve this collection of information, but as terms for clearance, filed comment. In filing comment on this collection of information, OMB requested that FDA examine public comment in response to the notice of proposed rulemaking and describe in the preamble of the final rule how the agency has maximized the practical utility of the collection and minimized the burden. Further, OMB requested for any future submissions of this information collection, FDA indicate the submission as “new” and reference OMB control number 0910-0590. In response to these **Federal Register** notices, FDA did not receive any comments regarding the information collection requirements contained in the final rule. In response to OMB's request that the agency describe how it has maximized the practical utility of this collection and minimized the burden, an explanation has been provided elsewhere in the preamble of this final rule. The information collection provisions of this final rule have been submitted to OMB for review. Prior to the effective date of this final rule, FDA will publish notice in the **Federal Register** , announcing OMB's decision to approve, modify, or disapprove the information collection provisions in this final rule. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information, unless it displays a currently valid OMB control number. *Title* : Designated New Animal Drugs for Minor Use and Minor Species—21 CFR Part 516, OMB Control No. 0910-0590. *Description* : The MUMS act amended (the act) to authorize FDA to establish new regulatory procedures intended to make more medications legally available to veterinarians and animal owners for the treatment of minor animal species as well as uncommon diseases in major animal species. This legislation provides incentives designed to help pharmaceutical companies overcome the financial burdens they face in providing limited-demand animal drugs. These incentives are only available to sponsors whose drugs are “MUMS-designated” by FDA. Minor use drugs are drugs for use in major species (cattle, horses, swine, chickens, turkeys, dogs, and cats) that are needed for diseases that occur in only a small number of animals either because they occur infrequently or in limited geographic areas. Minor species are all animals other than the major species, for example, zoo animals, ornamental fish, parrots, ferrets, and guinea pigs. Some animals of agricultural importance are also minor species. These include animals such as sheep, goats, catfish, and honeybees. Participation in the MUMS program is completely optional for drug sponsors so the associated paperwork only applies to those sponsors who request and are subsequently granted “MUMS designation.” The proposed rule will specify the criteria and procedures for requesting MUMS designation as well as the annual reporting requirements for MUMS designees. Under the new part 516, § 516.20 provides requirements on the content and format of a request for MUMS-drug designation, § 516.26 provides requirements for amending MUMS-drug designation, provisions for change in sponsorship of MUMS-drug designation can be found under § 516.27, under § 516.29 are provisions for termination of MUMS-drug designation, under § 516.30 are requirements for annual reports from sponsor(s) of MUMS designated drugs, and under § 516.36 are provisions for insufficient quantities of MUMS-designated drugs. *Description of Respondents* : Pharmaceutical companies that sponsor new animal drugs. FDA estimates the burden for this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 516.20 15 5 75 16 1,200 516.26 3 1 3 2 6 516.27 1 1 1 1 1 516.29 2 1 2 1 2 516.30 15 5 75 2 150 516.36 1 1 1 3 3 Total 1,362 1 There is no capital or operating and maintenance cost associated with this collection of information. VII. Environmental Impact We have carefully considered the potential environmental impacts of this final rule and determined under 21 CFR 25.30(h) 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. VIII. Federalism FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the agency has concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required. List of Subjects 21 CFR Part 20 Confidential business information, Courts, Freedom of information, Government employees. 21 CFR Part 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. 21 CFR Parts 514 and 516 Administrative practice and procedure, Animal drugs, Confidential business information, Reporting and recordkeeping requirements. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR chapter I is amended as follows: PART 20—PUBLIC INFORMATION 1. The authority citation for 21 CFR part 20 continues to read as follows: Authority: 5 U.S.C. 552; 18 U.S.C. 1905; 19 U.S.C. 2531-2582; 21 U.S.C. 321-393, 1401-1403; 42 U.S.C. 241, 242, 242a, 242l, 242n, 243, 262, 263, 263b-263n, 264, 265, 300u-300u-5, 300aa-1. 2. Amend § 20.100 by adding paragraph (c)(43) to read as follows: § 20.100 Applicability; cross-reference to other regulations.
(c)* * *
(43)Minor-use or minor-species
(MUMS)drug designations, in § 516.52 of this chapter. PART 510—NEW ANIMAL DRUGS 3. The authority citation for 21 CFR part 510 continues to read as follows: Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. 4. Amend § 510.3 by revising paragraph
(k)to read as follows: § 510.3 Definitions and interpretations.
(k)*Sponsor* means the person requesting designation for a minor-use or minor-species drug as defined in part 516 of this chapter, who must be the real party in interest of the development and the intended or actual production and sales of such drug (in this context, the sponsor may be an individual, partnership, organization, or association). Sponsor also means the person responsible for an investigation of a new animal drug. In this context, the sponsor may be an individual, partnership, corporation, or Government agency or may be a manufacturer, scientific institution, or an investigator regularly and lawfully engaged in the investigation of new animal drugs. Sponsor also means the person submitting or receiving approval for a new animal drug application (in this context, the sponsor may be an individual, partnership, organization, or association). In all contexts, the sponsor is responsible for compliance with applicable provisions of the act and regulations. PART 514—NEW ANIMAL DRUG APPLICATIONS 5. The authority citation for 21 CFR part 514 continues to read as follows: Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e, 381. § 514.1 [Amended] 6. Amend § 514.1 by removing paragraph (d). 7. Add part 516 to read as follows: PART 516—NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES Subpart A—General Provisions Sec. 516.1 Scope. 516.2 Purpose. 516.3 Definitions. Subpart B—Designation of a Minor Use or Minor Species New Animal Drug 516.11 Scope of this subpart. 516.12 Purpose. 516.13 Definitions. 516.14 Submission of requests for designation. 516.16 Eligibility to request designation. 516.20 Content and format of a request for MUMS-drug designation. 516.21 Documentation of minor use status. 516.22 Permanent-resident U.S. agent for foreign sponsor. 516.23 Timing of requests for MUMS-drug designation. 516.24 Granting MUMS-drug designation. 516.25 Refusal to grant MUMS-drug designation. 516.26 Amendment to MUMS-drug designation. 516.27 Change in sponsorship. 516.28 Publication of MUMS-drug designations. 516.29 Termination of MUMS-drug designation. 516.30 Annual reports for a MUMS-designated drug. 516.31 Scope of MUMS-drug exclusive marketing rights. 516.34 FDA recognition of exclusive marketing rights. 516.36 Insufficient quantities of MUMS-designated drugs. 516.52 Availability for public disclosure of data and information in requests. Subpart C—[Reserved] Subpart D—[Reserved] Authority: 21 U.S.C. 360ccc-2, 371. Subpart A—General Provisions § 516.1 Scope.
(a)This part implements section 573 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360ccc-2) and contains the following subparts:
(1)Subpart A—General Provisions.
(2)Subpart B—Designation of a Minor Use or Minor Species New Animal Drug.
(3)Subpart C—[Reserved]
(4)Subpart D—[Reserved]
(b)References in this part to regulatory sections of the Code of Federal Regulations are to Chapter I of Title 21, unless otherwise noted. § 516.2 Purpose. This part establishes standards and procedures for implementing section 573 of the act, including designation of minor use or minor species new animal drugs and associated exclusive marketing rights. § 516.3 Definitions.
(a)The definitions and interpretations contained in section 201 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321) apply to those terms when used in this part.
(b)The following definitions of terms apply to all subparts of part 516: *Active moiety* means the molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester, salt (including a salt with hydrogen or coordination bonds), or other noncovalent derivative (such as a complex, chelate, or clathrate) of the molecule, responsible for the pharmacological action of the drug substance. *Functionally superior* means that a drug has been shown to provide a significant therapeutic or physiologic advantage over that provided by a conditionally-approved or approved MUMS drug, that is otherwise the same drug, in one or more of the following ways:
(i)The drug has been shown to be more effective, as assessed by effect on a clinically meaningful endpoint in adequate and well-controlled clinical trials, than a conditionally approved or approved MUMS drug, that is otherwise the same drug. Generally, this would represent the same kind of evidence needed to support a comparative effectiveness claim for two different drugs; in most cases, direct comparative clinical trials will be necessary; or
(ii)The drug has been shown to be safer than a conditionally-approved or approved MUMS drug, that is otherwise the same drug, in a substantial portion of the target population, for example, by the elimination of an ingredient or contaminant that is associated with relatively frequent adverse effects. In some cases, direct comparative clinical trials will be necessary. *Infrequently* , as used in the minor use definition, means a disease or condition that is uncommon or that occurs only sporadically on an annualized basis. *Limited geographical areas* , as used in the minor use definition, means regions of the United States distinguished by physical, chemical, or biological factors that limit the distribution of a disease or condition. *Major species* means cattle, horses, swine, chickens, turkeys, dogs, and cats. *Minor species* means animals, other than humans, that are not major species. *Minor use* means the intended use of a drug in a major species for an indication that occurs infrequently and in only a small number of animals or in limited geographical areas and in only a small number of animals annually. *MUMS drug* means a new animal drug, as defined in section 201 of the act, intended for a minor use or for use in a minor species. *Same dosage form* means the same as one of the dosage forms specified in the following parts of this chapter:
(i)Part 520: Oral dosage form new animal drugs (excluding use in animal feeds as specified in part 558 of this chapter).
(ii)Part 522: Implantation or injectable dosage form new animal drugs.
(iii)Part 524: Ophthalmic and topical dosage form new animal drugs.
(iv)Part 526: Intramammary dosage forms.
(v)Part 529: Certain other dosage form new animal drugs.
(vi)Part 558: New animal drugs for use in animal feeds. *Same drug* means a MUMS drug for which designation, indexing, or conditional approval is sought that meets the following criteria:
(i)If it is a MUMS drug composed of small molecules and contains the same active moiety as a prior designated, conditionally-approved, or approved MUMS drug, even if the particular ester or salt (including a salt with hydrogen or coordination bonds) or other noncovalent derivative such as a complex, chelate or clathrate is not the same, it is considered the same drug; except that, if the prior MUMS drug is conditionally approved or approved and the second MUMS drug is shown to be functionally superior to the conditionally approved or approved MUMS drug for the same intended use, it is not considered the same drug.
(ii)If it is a MUMS drug composed of large molecules (macromolecules) and contains the same principal molecular structural features (but not necessarily all of the same structural features) as a prior designated, conditionally approved, or approved MUMS drug, it is considered the same drug; except that, if the prior MUMS drug is conditionally approved or approved and the second MUMS drug is shown to be functionally superior to the conditionally approved or approved MUMS drug for the same intended use, it is not considered the same drug. This criterion will be applied as follows to different kinds of macromolecules:
(A)Two protein drugs would be considered the same if the only differences in structure between them were due to post-translational events or infidelity of translation or transcription or were minor differences in amino acid sequence; other potentially important differences, such as different glycosylation patterns or different tertiary structures, would not cause the drugs to be considered different unless the subsequent drug is shown to be functionally superior.
(B)Two polysaccharide drugs would be considered the same if they had identical saccharide repeating units, even if the number of units were to vary and even if there were postpolymerization modifications, unless the subsequent drug is shown to be functionally superior.
(C)Two polynucleotide drugs consisting of two or more distinct nucleotides would be considered the same if they had an identical sequence of purine and pyrimidine bases (or their derivatives) bound to an identical sugar backbone (ribose, deoxyribose, or modifications of these sugars), unless the subsequent drug is shown to be functionally superior.
(D)Closely related, complex partly definable drugs with similar pharmacologic intent would be considered the same unless the subsequent drug is shown to be functionally superior. *Same intended use* means an intended use of a MUMS drug, for which designation, indexing, or conditional approval is sought, that is determined to be the same as (or not different from) a previously designated, conditionally approved, or approved intended use of a MUMS drug. Same intended use is established by comparing two intended uses and not by simply comparing the specific language by means of which the intent is established in labeling in accordance with the following criteria:
(i)Two intended uses are considered the same if one of the intended uses falls completely within the scope of the other.
(ii)For intended uses associated with diseases or conditions with multiple causative organisms, two intended uses are not considered the same when they involve different causative organisms or different subsets of causative organisms of that disease or condition when the causative organisms involved can reliably be shown to be clinically significant causes of the disease or condition.
(iii)Two intended uses of a drug are not considered the same if they involve different intended species or different definable subpopulations (including “production classes”) of a species. *Sponsor* means the person requesting designation for a MUMS drug who must be the real party in interest of the development and the intended or actual production and sales of such drug (in this context, the sponsor may be an individual, partnership, organization, or association). Sponsor also means the person responsible for an investigation of a new animal drug (in this context, the sponsor may be an individual, partnership, corporation, or Government agency or may be a manufacturer, scientific institution, or an investigator regularly and lawfully engaged in the investigation of new animal drugs). Sponsor also means the person submitting or receiving approval for a new animal drug application (in this context, the sponsor may be an individual, partnership, organization, or association). In all contexts, the sponsor is responsible for compliance with applicable provisions of the act and regulations. Subpart B—Designation of a Minor Use or Minor Species New Animal Drug § 516.11 Scope of this subpart. This subpart implements section 573 of the act. Specifically, this subpart sets forth the procedures and requirements for submissions to FDA of requests for designation of a new animal drug for a minor use or a minor species. § 516.12 Purpose. This subpart establishes standards and procedures for determining eligibility for designation and the associated incentives and benefits described in section 573 of the act, including a 7-year period of exclusive marketing rights. § 516.13 Definitions. The following definitions of terms apply only in the context of subpart B of this part: *Director* means the Director of the Office of Minor Use and Minor Species Animal Drug Development of the FDA Center for Veterinary Medicine. *Intended use* means the intended treatment, control or prevention of a disease or condition, or the intention to affect the structure or function of the body of animals within an identified species, subpopulation of a species, or collection of species. *MUMS-designated drug* means a new animal drug, as defined in section 201 of the act, intended for a minor use or for use in a minor species that has been designated under section 573 of the act. *MUMS-drug exclusive marketing rights* or *exclusive marketing rights* means that, effective on the date of FDA conditional approval or approval as stated in the approval letter of an application for a MUMS-designated drug, no conditional approval or approval will be given to a subsequent application for the same drug, in the same dosage form, for the same intended use for 7 years, except as otherwise provided by law or in this subpart. § 516.14 Submission of requests for designation. All correspondence relating to a request for designation of a MUMS drug must be addressed to the Director of the Office of Minor Use and Minor Species Animal Drug Development. Submissions not including all elements specified in § 516.20 will be returned to the sponsor without review. § 516.16 Eligibility to request designation. The person requesting designation must be the sponsor and the real party in interest of the development and the intended or actual production and sales of the drug or the permanent-resident U.S. agent for such a sponsor. § 516.20 Content and format of a request for MUMS-drug designation.
(a)A sponsor that submits a request for designation of a new animal drug intended for a minor use or minor species must submit each request in the form and containing the information required in paragraph
(b)of this section. While a request for designation may involve multiple intended uses, each request for designation must constitute a separate submission. A sponsor may request MUMS-drug designation of a previously unapproved drug, or a new intended use or dosage form for an already conditionally approved or approved drug. Only one sponsor may receive MUMS-drug designation of the same drug, in the same dosage form, for the same intended use.
(b)A sponsor must submit two copies of a completed, dated, and signed request for designation that contains the following information:
(1)A request for designation of a new animal drug for a minor use or use in a minor species, which must be specific.
(2)The name and address of the sponsor; the name of the sponsor's primary contact person and/or permanent-resident U.S. agent including title, address, and telephone number; the generic and trade name, if any, of the drug; and the name and address of the source of the drug.
(3)A description of the proposed intended use for which the drug is being or will be investigated.
(4)A description of the drug and dosage form.
(5)A discussion of the scientific rationale for the intended use of the drug; specific reference, including date(s) of submission, to all data from nonclinical laboratory studies, clinical investigations, copies of pertinent unpublished and published papers, and other relevant data that are available to the sponsor, whether positive, negative, or inconclusive.
(6)A specific description of the product development plan for the drug, its dosage form, and its intended use.
(7)If the drug is intended for a minor use in a major species, documentation in accordance with § 516.21, with appended authoritative references, to demonstrate that such use is a minor use.
(8)A statement that the sponsor submitting the request is the real party in interest of the development and the intended or actual production and sales of the product.
(9)A statement that the sponsor acknowledges that, upon granting a request for MUMS designation, FDA will make information regarding the designation publicly available as specified in § 516.28. § 516.21 Documentation of minor use status. So that FDA can determine whether a drug qualifies for MUMS-drug designation as a minor use in a major species under section 573 of the act, the sponsor shall include in its request to FDA for MUMS-drug designation under § 516.20 documentation demonstrating that the use is limited to a small number of animals (annualized). This documentation must include the following information:
(a)The estimated total number of animals to which the drug could potentially be administered on an annual basis for the treatment, control, or prevention of the disease or condition for which the drug is being developed, including animals administered the drug as part of herd or flock treatment, together with a list of the sources (including dates of information provided and literature citations) for the estimate.
(b)The estimated total number of animals referred to in paragraph
(a)of this section may be further reduced to only a subset of the estimated total number of animals if administration of the drug is only medically justified for this subset. To establish this, requestors must demonstrate that administration of the drug to animals subject to the disease or condition for which the drug is being developed other than the subset is not medically justified. The sponsor must also include a list of the sources (including dates of information provided and literature citations) for the justification that administration of the drug to animals other than the targeted subset is medically inappropriate.
(c)An estimate of the potential market associated with the total number of animals established in paragraph
(a)of this section compared to an estimate of the development costs of the proposed drug, in the proposed dosage form, for the proposed intended use. § 516.22 Permanent-resident U.S. agent for foreign sponsor. Every foreign sponsor that seeks MUMS-drug designation shall name a permanent resident of the United States as the sponsor's agent upon whom service of all processes, notices, orders, decisions, requirements, and other communications may be made on behalf of the sponsor. Notifications of changes in such agents or changes of address of agents should preferably be provided in advance, but not later than 60 days after the effective date of such changes. The permanent-resident U.S. agent may be an individual, firm, or domestic corporation and may represent any number of sponsors. The name and address of the permanent-resident U.S. agent shall be provided to the Director of the Office of Minor Use and Minor Species Animal Drug Development. § 516.23 Timing of requests for MUMS-drug designation. A sponsor may request MUMS-drug designation at any time in the drug development process prior to the submission of an application for either conditional approval or approval of the MUMS drug for which designation is being requested. § 516.24 Granting MUMS-drug designation.
(a)FDA may grant the request for MUMS-drug designation if none of the reasons described in § 516.25 for refusal to grant such a request apply.
(b)When a request for MUMS-drug designation is granted, FDA will notify the sponsor in writing and will give public notice of the MUMS-drug designation in accordance with § 516.28. § 516.25 Refusal to grant MUMS-drug designation.
(a)FDA will refuse to grant a request for MUMS-drug designation if any of the following reasons apply:
(1)The drug is not intended for use in a minor species or FDA determines that there is insufficient evidence to demonstrate that the drug is intended for a minor use in a major species.
(2)The drug is the same drug in the same dosage form for the same intended use as one that already has a MUMS-drug designation but has not yet been conditionally approved or approved.
(3)The drug is the same drug in the same dosage form for the same intended use as one that is already conditionally approved or approved. A drug that FDA has found to be functionally superior is not considered the same drug as an already conditionally approved or approved drug even if it is otherwise the same drug in the same dosage form for the same intended use.
(4)The sponsor has failed to provide:
(i)A credible scientific rationale in support of the intended use,
(ii)Sufficient information about the product development plan for the drug, its dosage form, and its intended use to establish that adherence to the plan can lead to successful drug development in a timely manner, and
(iii)Any other information required under § 516.20.
(b)FDA may refuse to grant a request for MUMS-drug designation if the request for designation contains an untrue statement of material fact or omits material information. § 516.26 Amendment to MUMS-drug designation.
(a)At any time prior to conditional approval or approval of an application for a MUMS-designated drug, the sponsor may apply for an amendment to the designated intended use if the proposed change is due to new and unexpected findings in research on the drug, information arising from FDA recommendations, or other unforeseen developments.
(b)FDA will grant the amendment if it finds:
(1)That the initial designation request was made in good faith;
(2)That the amendment is intended to make the MUMS-drug designated intended use conform to the results of new and unexpected findings in research on the drug, information arising from FDA recommendations, or other unforeseen developments; and
(3)In the case of a minor use, that as of the date of the submission of the amendment request, the amendment would not result in the intended use of the drug no longer being considered a minor use. § 516.27 Change in sponsorship.
(a)A sponsor may transfer sponsorship of a MUMS-designated drug to another person. A change of sponsorship will also transfer the designation status of the drug which will remain in effect for the new sponsor subject to the same conditions applicable to the former sponsor provided that at the time of a potential transfer, the new and former sponsors submit the following information in writing and obtain permission from FDA:
(1)The former sponsor shall submit a letter to FDA that documents the transfer of sponsorship of the MUMS-designated drug. This letter shall specify the date of the transfer. The former sponsor shall also certify in writing to FDA that a complete copy of the request for MUMS-drug designation, including any amendments to the request, and correspondence relevant to the MUMS-drug designation, has been provided to the new sponsor.
(2)The new sponsor shall submit a letter or other document containing the following information:
(i)A statement accepting the MUMS-drug designated file or application;
(ii)The date that the change in sponsorship is intended to be effective;
(iii)A statement that the new sponsor has a complete copy of the request for MUMS-drug designation, including any amendments to the request and any correspondence relevant to the MUMS-drug designation;
(iv)A statement that the new sponsor understands and accepts the responsibilities of a sponsor of a MUMS-designated drug established elsewhere in this subpart;
(v)The name and address of a new primary contact person or permanent resident U.S. agent; and
(vi)Evidence that the new sponsor is capable of actively pursuing approval with due diligence.
(b)No sponsor may relieve itself of responsibilities under the act or under this subpart by assigning rights to another person without:
(1)Assuring that the new sponsor will carry out such responsibilities; and
(2)Obtaining prior permission from FDA. § 516.28 Publication of MUMS-drug designations. FDA will periodically update a publicly available list of MUMS-designated drugs. This list will be placed on file at the FDA Division of Dockets Management, and will contain the following information for each MUMS-designated drug:
(a)The name and address of the sponsor;
(b)The established name and trade name, if any, of the drug;
(c)The dosage form of the drug;
(d)The species and the proposed intended use for which MUMS-drug designation was granted; and
(e)The date designation was granted. § 516.29 Termination of MUMS-drug designation.
(a)The sponsor of a MUMS-designated drug must notify FDA of any decision to discontinue active pursuit of conditional approval or approval of such MUMS drug. FDA must terminate the designation upon such notification.
(b)A conditionally-approved or approved MUMS-designated drug sponsor must notify FDA at least 1 year before it intends to discontinue the manufacture of such MUMS drug. FDA must terminate designation upon such notification.
(c)MUMS designation shall terminate upon the expiration of any applicable period of exclusive marketing rights under this subpart.
(d)FDA may terminate designation if it independently determines that the sponsor is not actively pursuing conditional approval or approval with due diligence. At a minimum, due diligence must be demonstrated by:
(1)Submission of annual progress reports in a timely manner in accordance with § 516.30 that demonstrate that the sponsor is progressing in accordance with the drug development plan submitted to the agency under § 516.20 and
(2)Compliance with all applicable requirements of part 511 of this chapter.
(e)Designation of a conditionally approved or approved MUMS-designated drug and the associated exclusive marketing rights may be terminated if the sponsor is unable to provide sufficient quantities of the drug to meet the needs for which it is designated.
(f)FDA may also terminate MUMS-drug designation for any drug if the agency finds that:
(1)The request for designation contained an untrue statement of material fact; or
(2)The request for designation omitted material information required by this subpart; or
(3)FDA subsequently finds that the drug in fact had not been eligible for MUMS-drug designation at the time of submission of the request;
(4)The same drug, in the same dosage form, for the same intended use becomes conditionally approved or approved for another sponsor; or
(5)FDA withdraws the conditional approval or approval of the application for the new animal drug.
(g)For a conditionally approved or approved drug, termination of MUMS-drug designation also terminates the sponsor's exclusive marketing rights for the drug but does not withdraw the conditional approval or approval of the drug's application.
(h)Where a drug has been MUMS-designated for a minor use in a major species, its designation will not be terminated on the grounds that the number of animals to which the drug could potentially be administered on an annual basis for the treatment, control, or prevention of the disease or condition for which the drug is being developed, including animals administered the drug as part of herd or flock treatment, subsequently increases.
(i)When a MUMS-drug designation is terminated, FDA will notify the sponsor in writing and will give public notice of the termination of the MUMS-drug designation. § 516.30 Annual reports for a MUMS-designated drug. Within 14 months after the date on which a MUMS drug is granted designation and annually thereafter until approval, the sponsor of a MUMS-designated drug shall submit a brief progress report on the drug to the investigational new animal drug file addressed to the Director of the Office of Minor Use and Minor Species Animal Drug Development that includes the following information:
(a)A short account of the progress of drug development including a description of studies initiated, ongoing, and completed, and a short summary of the status or results of such studies;
(b)A description of the investigational plan for the coming year, as well as any anticipated difficulties in development, testing, and marketing; and
(c)A brief discussion of any changes that may affect the MUMS-designated drug status of the product. For example, situations in which testing data demonstrate that the proposed intended use is inappropriate due to unexpected issues of safety or effectiveness. § 516.31 Scope of MUMS-drug exclusive marketing rights.
(a)After conditional approval or approval of an application for a MUMS-designated drug in the dosage form and for the intended use for which MUMS-drug designation has been granted, FDA will not conditionally approve or approve another application or abbreviated application for the same drug in the same dosage form for the same intended use before the expiration of 7 years after the date of conditional approval or approval as stated in the approval letter from FDA, except that such an application can be conditionally approved or approved sooner if, and at such time as, any of the following occurs:
(1)FDA terminates the MUMS-drug designation and associated exclusive marketing rights under § 516.29; or
(2)FDA withdraws the conditional approval or approval of the application for the drug for any reason; or
(3)The sponsor with exclusive marketing rights provides written consent to FDA to conditionally approve or approve another application before the expiration of 7 years; or
(4)The sponsor fails to assure a sufficient quantity of the drug in accordance with section 573 of the act and § 516.36.
(b)If an application for a MUMS drug cannot be approved until the expiration of the period of exclusive marketing of a MUMS-designated drug, FDA will so notify the sponsor in writing. § 516.34 FDA recognition of exclusive marketing rights.
(a)FDA will send the sponsor (or the permanent-resident U.S. agent, if applicable) timely written notice recognizing exclusive marketing rights when an application for a MUMS- designated drug has been conditionally approved or approved. The written notice will inform the sponsor of the requirements for maintaining MUMS-designated drug exclusive marketing rights for the full 7-year term. This notice will generally be contained in the letter conditionally approving or approving the application.
(b)When an application is conditionally approved or approved for a MUMS-designated drug that qualifies for exclusive marketing rights, FDA will publish this information in the **Federal Register** at the time of the conditional approval or approval. This notice will generally be contained in the notice of conditional approval or approval of the application. § 516.36 Insufficient quantities of MUMS-designated drugs.
(a)Under section 573 of the act, whenever FDA has reason to believe that sufficient quantities of a conditionally-approved or approved, MUMS-designated drug to meet the needs for which the drug was designated cannot be assured by the sponsor, FDA will so notify the sponsor of this possible insufficiency and will offer the sponsor the following options, one of which must be exercised by a time that FDA specifies:
(1)Provide FDA information and data regarding how the sponsor can assure the availability of sufficient quantities of the MUMS-designated drug within a reasonable time to meet the needs for which the drug was designated; or
(2)Provide FDA in writing the sponsor's consent for the conditional approval or approval of other applications for the same drug before the expiration of the 7-year period of exclusive marketing rights.
(b)If, within the time that FDA specifies, the sponsor fails to consent to the conditional approval or approval of other applications and if FDA finds that the sponsor has not shown that it can assure the availability of sufficient quantities of the MUMS-designated drug to meet the needs for which the drug was designated, FDA will issue a written order terminating designation of the MUMS drug and the associated exclusive marketing rights. This order will state FDA's findings and conclusions and will constitute final agency action. An order terminating designation and associated exclusive marketing rights may issue whether or not there are other sponsors that can assure the availability of alternative sources of supply. Such an order will not withdraw the conditional approval or approval of an application. Once terminated under this section, neither designation, nor exclusive marketing rights may be reinstated. § 516.52 Availability for public disclosure of data and information in requests.
(a)FDA will not publicly disclose the existence of a request for MUMS-drug designation under section 573 of the act prior to final FDA action on the request unless the existence of the request has been previously publicly disclosed or acknowledged.
(b)Whether or not the existence of a pending request for designation has been publicly disclosed or acknowledged, no data or information in the request are available for public disclosure prior to final FDA action on the request.
(c)Except as provided in paragraph
(d)of this section, upon final FDA action on a request for designation, the public availability of data and information in the request will be determined in accordance with part 20 of this chapter and other applicable statutes and regulations.
(d)In accordance with § 516.28, FDA will make a cumulative list of all MUMS-drug designations available to the public and update such list periodically. In accordance with § 516.29, FDA will give public notice of the termination of all MUMS-drug designations. Subpart C—[Reserved] Subpart D—[Reserved] Dated: March 12, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. Editorial Note: This document was received at the Office of the Federal Register on July 23, 2007. [FR Doc. E7-14444 Filed 7-25-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 301 [TD 9333] RIN 1545-BG64 Application of Section 6404(g) of the Internal Revenue Code Suspension Provisions; Correction AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Correction to temporary regulations. SUMMARY: This document contains corrections to temporary regulations (TD 9333) that were published in the **Federal Register** on Thursday, June 21, 2007 (72 FR 34176) on the suspension of any interest, penalty, addition to tax, or additional amount with respect to listed transactions or undisclosed reportable transactions. The temporary regulations provide guidance to individual taxpayers who have participated in listed transactions or undisclosed reportable transactions. DATES: The correction is effective July 26, 2007. FOR FURTHER INFORMATION CONTACT: Stuart Spielman,
(202)622-7950 (not a toll-free number). SUPPLEMENTARY INFORMATION: Background The temporary regulations that are the subject of this correction are under section 6404(g) of the Internal Revenue Code. Need for Correction As published, temporary regulations (TD 9333) contain errors that may prove to be misleading and are in need of clarification. Correction of Publication Accordingly, the publication of the temporary regulations (TD 9333), which was the subject of FR Doc. E7-12081, is corrected as follows: 1. On page 34176, column 2, in the preamble, under the caption “ SUMMARY: ”, lines 13 and 14, the language “Opportunity Zone Act of 2005, and the Tax Relief and Health Care Act of 2006.” is corrected to read “Opportunity Zone Act of 2005, the Tax Relief and Health Care Act of 2006, and the Small Business and Work Opportunity Tax Act of 2007.”. 2. On page 34176, column 3, in the preamble, under the paragraph heading “Background”, line 8 from the bottom of the paragraph, the language “Public Law 110-28 (121 Stat. 112, 200),” is corrected to read “Public Law 110-28 (121 Stat. 190, 200),”. LaNita Van Dyke, Chief, Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel (Procedure and Administration). [FR Doc. E7-14398 Filed 7-25-07; 8:45 am] BILLING CODE 4830-01-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket No. CGD05-07-043] RIN 1625-AA08 Special Local Regulations for Marine Events; Chesapeake Bay, Cape Charles, VA AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing special local regulations during the “East Coast Boat Racing Club power boat race”, a marine event to be held over the waters of the Chesapeake Bay adjacent to Cape Charles, Virginia. These special local regulations are necessary to provide for the safety of life on navigable waters during the event. This action is intended to restrict vessel traffic on the Chesapeake Bay in the vicinity of Cape Charles Beach, Cape Charles, Virginia during the event. DATES: This rule is effective from 11:30 a.m. on August 4, 2007 through 4:30 p.m. on August 5, 2007. ADDRESSES: Comments and material received from the public, as well as documents indicated in this preamble as being available in the docket, are part of docket CGD05-07-043 and are available for inspection or copying at Commander (dpi), Fifth Coast Guard District, 431 Crawford Street, Portsmouth, Virginia 23704-5004 between 9 a.m. and 2 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: Dennis Sens, Project Manager, Fifth Coast Guard District, Inspections and Investigations Branch, at
(757)398-6204. SUPPLEMENTARY INFORMATION: Regulatory Information On May 22, 2007, we published a notice of proposed rulemaking
(NPRM)entitled Special Local Regulations for Marine Events; Chesapeake Bay, Cape Charles, VA in the **Federal Register** (72 FR 28631). We received no letters commenting on the proposed rule. No public meeting was requested, and none was held. Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the **Federal Register** . Delaying the effective date would be contrary to the public interest, since immediate action is needed to ensure the safety of the event participants, spectator craft and other vessels transiting the event area. However advance notifications will be made to affected waterway users via marine information broadcasts, local radio stations, and area newspapers. Background and Purpose On August 4, 2007, the East Coast Boat Racing Club of New Jersey will sponsor a power boat race, on the waters of the Chesapeake Bay, Cape Charles, Virginia. The event will consist of approximately 20 New Jersey Speed Garveys and Jersey Speed Skiffs conducting high-speed competitive races along an oval race course in close proximity to Cape Charles Beach, Cape Charles, Virginia. A fleet of spectator vessels is expected to gather nearby to view the competition. Due to the need for vessel control during the event, vessel traffic will be temporarily restricted to provide for the safety of participants, spectators and transiting vessels. Discussion of Comments and Changes The Coast Guard did not receive comments in response to the notice of proposed rulemaking
(NPRM)published in the **Federal Register** . Accordingly, the Coast Guard is establishing temporary special local regulations on specified waters of the Chesapeake Bay, Cape Charles, Virginia. Regulatory Evaluation This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation is unnecessary. Although this regulation will prevent traffic from transiting a portion of the Chesapeake Bay during the event, the effect of this regulation will not be significant due to the limited duration that the regulated area will be in effect and the extensive advance notifications that will be made to the maritime community via the Local Notice to Mariners, marine information broadcasts, and area newspapers, so mariners can adjust their plans accordingly. Additionally, the regulated area has been narrowly tailored to impose the least impact on general navigation yet provide the level of safety deemed necessary. Vessel traffic will be able to transit the regulated area between heats, when the Coast Guard Patrol Commander deems it is safe to do so. Small Entities Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule would affect the following entities, some of which might be small entities: The owners or operators of vessels intending to transit or anchor in this portion of the Chesapeake Bay adjacent to Cape Charles Beach during the event. This rule would not have a significant economic impact on a substantial number of small entities for the following reasons. This rule would be in effect for only a limited period. Vessel traffic will be able to transit the regulated area between heats, when the Coast Guard Patrol Commander deems it is safe to do so. Before the enforcement period, we will issue maritime advisories so mariners can adjust their plans accordingly. Assistance for Small Entities Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard. Collection of Information This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Federalism A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism. Unfunded Mandates Reform Act The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble. Taking of Private Property This rule will not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights. Civil Justice Reform This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden. Protection of Children We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children. Indian Tribal Governments This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Energy Effects We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211. Technical Standards The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( *e.g.* , specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies. This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards. Environment We have analyzed this rule under Commandant Instruction M16475.lD and Department of Homeland Security Management Directive 5100.1, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969
(NEPA)(42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(h), of the Instruction, from further environmental documentation. Special local regulations issued in conjunction with a regatta or marine parade permit are specifically excluded from further analysis and documentation under that section. Under figure 2-1, paragraph (34)(h), of the Instruction, an “Environmental Analysis Check List” and a “Categorical Exclusion Determination” are not required for this rule. List of Subjects in 33 CFR Part 100 Marine safety, Navigation (water), Reporting and recordkeeping requirements, Waterways. For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows: PART 100—REGATTAS AND MARINE PARADES 1. The authority citation for part 100 continues to read as follows: Authority: 33 U.S.C. 1233. 2. Add a temporary § 100.35-T05-043 to read as follows: § 100.35-T05-043 Chesapeake Bay, Cape Charles, Virginia.
(a)*Regulated area* includes the waters of the Chesapeake Bay, along the shoreline adjacent to Cape Charles, Virginia, to and including waters up to 300 yards offshore, parallel with the Cape Charles Beach shoreline in this area. The area is bounded on the south by a line running northwesterly from the Cape Charles shoreline at latitude 37°16′.2″ North, longitude 076°01′28.5″ West, to a point offshore approximately 300 yards at latitude 37°16′3.4″ North, longitude 076°01′36.6″ West, and bounded on the north by a line running northwesterly from the Cape Charles shoreline at latitude 37°16′26.2″ North, longitude 076°01′14″ West, to a point offshore approximately 300 yards at latitude 37°16′28.9″ North, longitude 076°01′24.1″ West. All coordinates reference Datum NAD 1983.
(b)*Definitions* .
(1)*Coast Guard Patrol Commander* means a commissioned, warrant, or petty officer of the Coast Guard who has been designated by the Commander, Coast Guard Sector Hampton Roads.
(2)*Official Patrol* means any vessel assigned or approved by Commander, Coast Guard Sector Hampton Roads with a commissioned, warrant, or petty officer on board and displaying a Coast Guard ensign.
(3)*Participant* includes all vessels participating in the East Coast Boat Racing Club power boat race under the auspices of a Marine Event Permit issued to the event sponsor and approved by Commander, Coast Guard Sector Hampton Roads.
(c)*Special local regulations* .
(1)Except for event participants and persons or vessels authorized by the Coast Guard Patrol Commander, no person or vessel may enter or remain in the regulated area.
(2)The operator of any vessel in the regulated area shall:
(i)Stop the vessel immediately when directed to do so by any Official Patrol.
(ii)Proceed as directed by any Official Patrol.
(iii)When authorized to transit the regulated area, all vessels shall proceed at the minimum speed necessary to maintain a safe course that minimizes wake near the race course.
(d)*Effective period* . This section will enforced from 11:30 a.m. to 4:30 p.m. on August 4, 2007. If the race is postponed due to weather, then the temporary special local regulations will be enforced during the same time period the next day, August 5, 2007. Dated: July 16, 2007. Neil O. Buschman, Captain, U.S. Coast Guard, Commander, Fifth Coast Guard District, Acting. [FR Doc. E7-14401 Filed 7-25-07; 8:45 am] BILLING CODE 4910-15-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 70 [Docket No. EPA-R02-OAR-2006-0963, FRL-8446-4] Approval of New Jersey's Title V Operating Permit Program Revision AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: The Environmental Protection Agency is approving a revision to the New Jersey Operating Permit Program related to the permitting of stationary sources subject to title V of the Clean Air Act in the state of New Jersey. The revision consists of amendments to Subchapter 22 of Chapter 27 of Title 7 of the New Jersey Administrative Code, “Operating Permits.” The revision was submitted to amend the definition, permit application, and fees sections of the Operating Permit Rule. The changes add clarity to the rule and assure adequate funding for New Jersey's Operating Permit Program. The intended effect of this action is to approve the program revision requested by New Jersey to assure proper implementation of the requirements of title V of the CAA. DATES: *Effective Date:* This rule will be effective August 27, 2007. ADDRESSES: EPA has established a docket for this action under the Federal Docket Management System
(FDMS)which replaces the Regional Materials in EDOCKET
(RME)docket system. The new FDMS is located at *http://www.regulations.gov* and the docket ID for this action is EPA-R02-OAR-2006-0963. All documents in the docket are listed in the FDMS index. Publicly available docket materials are available either electronically in FDMS or in hard copy at the Environmental Protection Agency, Region 2 Office, Air Programs Branch, 290 Broadway, 25th Floor, New York, New York 10007-1866. Copies of the documents relevant to this action are also available for public inspection during normal business hours, by appointment at the New Jersey Department of Environmental Protection, Division of Air Quality, 401 East State Street, Trenton, New Jersey 08625. FOR FURTHER INFORMATION CONTACT: Suilin Chan, Air Programs Branch, Environmental Protection Agency, 290 Broadway, 25th Floor, New York, New York 10007-1866,
(212)637-4019. SUPPLEMENTARY INFORMATION: I. What was included in New Jersey's submittal? On October 4, 2006, New Jersey Department of Environmental Protection (NJDEP) submitted to EPA a request to revise its Operating Permits Rule. The revisions consisted of amendments to sections 22.1, 22.3, 22.4, 22.6, 22.10, and 22.31 of the Operating Permits Rule codified at Title 7 of the New Jersey Administrative Code, Chapter 27, Subchapter 22. These revisions were adopted by the State on May 1, 2006 (inadvertently listed June 9, 2006 as the adoption date in the proposal) and became effective on June 19, 2006. On March 20, 2007 (72 FR 13059), EPA proposed to approve the revised Subchapter 22 as part of New Jersey's Operating Permits Rule. For a detailed discussion on the content of the revisions to New Jersey's rule, the reader is referred to EPA's proposed rulemaking action. II. What comments did EPA receive in response to its proposal? In response to EPA's March 20, 2007, proposed rulemaking action, EPA received no comments. III. What is EPA's conclusion? EPA has evaluated New Jersey's submittal for consistency with the Act, EPA regulations, and EPA policy. EPA has determined that the revisions to Subchapter 22, New Jersey's Operating Permits Rule meet title V of the CAA and its implementing regulations codified at Title 40 of the Code of Federal Regulations, part 70. Therefore, EPA is approving the subject revisions. IV. 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 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 is not economically significant. In reviewing State Operating Permit Programs submitted pursuant to title V of the Clean Air Act, EPA will approve such regulations 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 such regulations for failure to use VCS. It would, thus, be inconsistent with applicable law for EPA, when it reviews such regulations, to use VCS in place of a State regulation 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. section 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. section 804(2). Under section 307(b)(1) of the Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by September 24, 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 70 Environmental protection, Administrative practice and procedure, Air pollution control, Reporting and recordkeeping requirements. Dated: July 8, 2007. Alan J. Steinberg, Regional Administrator, Region 2. Part 70, chapter I, 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
(d)to the entry for New Jersey to read as follows: Appendix A to Part 70—Approval Status of State and Local Operating Permit Programs New Jersey
(d)The New Jersey Department of Environmental Protection submitted program revisions on October 4, 2006; approval effective August 27, 2007. [FR Doc. E7-14483 Filed 7-25-07; 8:45 am] BILLING CODE 6560-50-P 72 143 Thursday, July 26, 2007 Proposed Rules DEPARTMENT OF AGRICULTURE Agricultural Research Service 7 CFR Part 550 RIN 0518-AA03 General Administrative Policy for Non-Assistance Cooperative Agreements AGENCY: Agricultural Research Service, Education, and Economics; USDA. ACTION: Proposed rule. SUMMARY: This Part establishes uniform guidelines within the Research, Education, and Economics
(REE)mission area on the use, award, and administration of cooperative agreements awarded under the authority of 7 U.S.C. 3318(b). DATES: Submit comments on or before September 24, 2007. ADDRESSES: Send comments to Kim Hicks, Agricultural Research Service, Extramural Agreements Division, MS-5110, 5601 Sunnyside Ave., Beltsville, MD 20705-5110. FOR FURTHER INFORMATION CONTACT: Kim Hicks, Chief, Grants & Agreements Management Staff, ARS 5601 Sunnyside Ave., Beltsville, MD 20705-5110; Telephone:
(301)504-1141, Fax:
(301)504-1262; E-mail: *kim.hicks@ars.usda.gov.* SUPPLEMENTARY INFORMATION: Background Section 1424 of the Food Security Act of 1985, Public Law 99-198, amended Section 1472(b) of the National Agricultural Research, Extension, and Teaching Policy Act of 1977 (7 U.S.C. 3318(b)) to authorize the Secretary to use a cooperative agreement as a legal instrument reflecting a relationship between the Secretary and a State cooperative institution, State department of agriculture, college, university, other research or educational institution or organization, Federal or private agency or organization, individual, or any other party, if the Secretary determines
(a)The objectives of the agreement will serve a mutual interest of the parties to the agreement in agricultural research, extension, and teaching activities, including statistical reporting; and
(b)all parties will contribute resources to the accomplishment of those objectives. The cooperative agreements authorized by 7 U.S.C. 3318(b) have been determined to be neither procurement nor assistance in nature and, therefore, not subject to the provisions of Federal Grant and Cooperative Agreement Act of 1977. These cooperative agreements are exempt from Department of Agriculture
(USDA)rules and regulations promulgated at 7 CFR parts 3015, 3016, and 3019. The agreements covered by this Part are characterized by mutual interest and benefit to both parties, and reflect the unique cooperative relationship that exists between the REE agencies and the various public and private organizations engaged in the conduct of agricultural research, extension, and teaching activities. Although the nonassistance cooperative agreements described in this Rule are substantively different than the Federal assistance-type cooperative agreements used by most Federal awarding agencies and are not subject to the grants management Common Rule found at 2 CFR part 215, “Uniform Administrative Requirements for Grants and Agreements With Institutions of Higher Education, Hospitals and Other Non-profit Organizations,” REE has decided to apply many of the provisions of the Common Rule as a matter of good business practice. Many of the standards and provisions of the Common Rule have been adopted in whole or in part in the proposed rule because they embody principles of good management and sound financial stewardship important to all Federal assistance and nonassistance awards. Additionally, we have included by reference specific provisions of other Federal assistance-type or procurement guidance documents such as 7 CFR 3052, 42 U.S.C. 6962, and the Cash Management Improvement Act, codified at 31 CFR part 205, for the same reasons. Summary of Proposed Rule This part provides a summary of some of the more significant sections of the rule as well as background information that will be used in reading and interpreting it. Sections on Definitions, Applicability, Competition policy, Duration of the agreement, Special Award Conditions and others, provide general information on REE requirements and expectations. Some of the sections contain provisions that apply only to statutes authorizing nonassistance cooperative agreements and may be unfamiliar to those that normally work under Federal assistance-type cooperative agreements and grants. We are providing an analysis of some of the specific provisions of the sections in this part in an attempt to provide the commenter with a better understanding of their context in the rule and the reasons that they were written. Although commenters may offer comments on all aspects of this proposed rule there are a number of areas that are required by statute and therefore cannot be changed. We offer additional explanation and information on the following sections of this Part: Subpart A—General Definitions The definitions used in this Part are derived from several sources. They include USDA's implementation of Office of Management and Budget
(OMB)Circular A-110 at 7 CFR part 3019 (2 CFR part 215), certain REE statutes authorizing the use of non-assistance agreements and other terms and definitions that have been commonly used in conjunction with REE's non-assistance agreement programs. Eligibility The eligibility standards referenced in this section were determined by statute. (7 U.S.C. 3318(b)(1)). Competition The non-assistance agreements awarded under this authority can be made without regard to any requirements for competition. The policy regarding competition referenced in this section was determined by statute. (7 U.S.C. 3318(e)) Duration REE Agencies may enter into non-assistance cooperative agreements for a period not to exceed 5 years. Subpart B—Formation of Agreements Mutuality of Interest The principle of mutuality of interest is extremely important in REE programs in which non-assistance agreements are used. Mutuality of interest is the cornerstone upon which decisions to enter into specific relationships with cooperators, on specific projects, are based. The statute authorizing the use of nonassistance cooperative agreements has, as one of the two principles for its use, the following provision: “* * * the objectives of the agreement will serve a mutual interest of the parties to the agreement * * *” Indirect Cost The prohibitions and restrictions on payment of indirect costs on non-assistance cooperative agreements are based in statute (7 U.S.C. 3319). Payment of indirect costs to State Cooperative Institutions referenced in the Definitions section of this document is prohibited. This prohibition does not apply to funds for international agricultural programs conducted by a State cooperative institution and administered by the Secretary or to funds provided by a Federal agency for such cooperative program or project through a fund transfer, advance or reimbursement (7 U.S.C. 3319). Payment of indirect costs to non-profit organizations is limited to 10 percent of the total direct cost of the project. In accordance with the annual appropriations language as specified in the cooperative agreement General Provisions, payment of indirect costs on REE nonassistance cooperative agreements with all other cooperating organizations is limited to the percentage(s) established in the Cooperator's negotiated indirect cost rate schedule. Resource Contribution This section details the resource contributions that are required of Cooperators when participating in REE non-assistance cooperative agreements. Historically, there were no firm guidelines or requirements regarding the minimum contribution of resources on REE projects documented by non-assistance cooperative agreements. Contributions were expected to be “* * * more than nominal.” This vague guidance led to disparities among the contributions put forward by various organizations, confusion and a lack of direction among all parties charged with negotiating these awards and, in some cases a lack of true commitment to the project objectives on the part of the cooperator. In a 1993 USDA, Office of General Counsel
(OGC)opinion it was noted that the contributions that are required under the statute “* * * must be substantial enough to evoke a partnership type relationship such that all parties to the agreement have a real stake in the activity * * *” and that “* * * the exact amount that each party must contribute is a policy decision best left to the discretion of the agency.” REE Agencies have now established a minimum resource contribution of no less than 20 percent of the funded amount of the agreement. This decision was made after consultation with other USDA agencies and other Federal agencies. While it was noted during this consultation process that some other agencies had higher minimums of resource contributions, REE Agencies decided that a 20 percent minimum was reasonable and efficacious. Further, REE Agencies decided that the contribution required of cooperators could consist of “in kind” contributions and unrecoverable indirect costs. The section goes on to cite and define these in kind contributions in a manner that is consistent with the standard practices found in Federal agencies' implementation of OMB's guidance to Federal agencies found at 2 CFR part 215. As Federal resources become more scarce due to budget limitations it may become necessary to make changes to the way in which these costs are calculated. REE Agencies reserve the right and authority to increase the amount of the minimum contribution if and when it is necessary to do so. Payment Due to the true collaborative nature of the research and other projects that REE Agencies enter into with their cooperators REE has determined that the reimbursement method of payment is the preferred method of payment for nonassistance cooperative agreements. While advance payment has proven to be the most reasonable approach for payments to grantees under grant programs, REE Agencies have determined that the most effective method of payment under nonassistance cooperative agreements is the reimbursement method of payment. The reimbursement method of payment utilizes Electronic Fund Transfers which are common to most recipient organizations and the technology has been in use for many years with nearly seamless efficiency. Subpart C—Management of Agreements The Management of Agreements sections of this rule closely parallel the provisions of OMB's Circular A-110, codified as 2 CFR part 215 and other provisions previously published in USDA regulations found at 7 CFR part 3015 and successor regulations. Because most educational institutions and other organizations covered by this rule are already subject to these provisions, and because the provisions have been previously approved under other Federal rulemaking efforts, we believe it unnecessary to further explain their purpose or place in this rule. We will review other aspects of the rule that differ due either to statutory exception or Agency discretion. Section 550.29 Press Releases. REE agencies are involved in a wide variety of research projects in many different areas of research. Some of these projects involve national security concerns or classified areas of research and are performed in cooperation with the Department of Homeland Security or other Federal protection agencies. This section was added to assure that only appropriate information is released to the public on REE projects. Section 550.30 Advertising. This section was developed in order to preclude Cooperators from claiming the endorsement of USDA on products or research results that were funded either directly, or indirectly, by the Federal government. Statements that include references to the REE agency in advertising media can imply the endorsement of the Federal government at large. This provision would not preclude such references but would require prior approval for their use. Section 550.32 Project Supervision and Responsibilities and Section 550.33 Administrative Supervision were included here to assist in the delineation of duties between the Cooperator and the REE agency. This is necessary due to the extremely close collaboration between agency employees and the employees of the Cooperator. In many cases the employees of both entities work side-by-side often causing difficult work situations when it comes to matters such as overtime and holiday hours, and other common workplace and workday rules. The provisions of this section are an attempt to clarify some of the roles and rules that have historically presented challenges to administrators and program leaders of both entities. Procurement Standards The Procurement Standards established in this Part are consistent with the standards set out in 2 CFR part 215 and USDA's Federal assistance regulations at 7 CFR part 3019. Executive Order 12866 and Regulatory Flexibility Act This proposed rule has been reviewed under Executive Order 12866. The rule has been determined to be not significant for the purposes of Executive Order 12866. Executive Order 12372 The programs covered by these regulations are listed in the Catalog of Federal Domestic Assistance
(CFDA)under the following CFDA numbers: the Agricultural Research Service found at 10.001; the Economics Research Service found at 10.250; and the National Agricultural Statistics Service found at 10.950. Because this proposed regulation does not authorize any programs or program expenditures, this notice is not subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 7 CFR Part 3015, subpart V.) Executive Order 12988—Civil Justice Reform This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. If this proposed rule is adopted:
(1)State and local laws and regulations will not be preempted;
(2)no retroactive effect will be given to this rule; and
(3)administrative proceedings will not be required before parties may file suit in court challenging this rule. Paperwork Reduction Act In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ), the information collection or recordkeeping requirements included in this proposed rule will be submitted for approval to the Office of Management and Budget (OMB). List of Subjects in Part 550 Agricultural research, Non-assistance, Procedural rules, Research, Science and technology. For the reasons stated in the preamble, the Department of Agriculture, Agriculture Research Service, proposes to amend 7 CFR chapter V by adding part 550 as set forth below. PART 550—GENERAL ADMINISTRATIVE POLICY FOR NON-ASSISTANCE COOPERATIVE AGREEMENTS Subpart A—General Sec. 550.1 Purpose and scope. 550.2 Definitions. 550.3 Applicability. 550.4 Eligibility. 550.5 Competition. 550.6 Duration. 550.7 Exceptions. 550.8 Conflicting policies and deviations. 550.9 Other applicable regulations. 550.10 Special Award Conditions. Subpart B—Formation of Agreements 550.11 Purpose. 550.12 Statutory authorization required (REE Agency). 550.13 Mutuality of interest. 550.14 Indirect costs/tuition remission. 550.15 Resource contribution. 550.16 Project development. 550.17 Peer review. 550.18 Assurances/certifications. Subpart C—Management of Agreements Financial Management 550.19 Purpose. 550.20 Standards for financial management systems. 550.21 Funding availability. 550.22 Payment. 550.23 Program income. 550.24 Non-Federal audits. 550.25 Allowable costs. Program Management 550.26 Monitoring program performance. 550.27 Prior approvals. 550.28 Publications and acknowledgement of support. 550.29 Press releases. 550.30 Advertising. 550.31 Questionnaires and survey plans. 550.32 Project supervision and responsibilities. 550.33 Administrative supervision. 550.34 Research misconduct. 550.35 Rules of the workplace. Equipment/Property Standards 550.36 Purpose of equipment/property standards. 550.37 Title to equipment. 550.38 Equipment. 550.39 Equipment replacement insurance 550.40 Supplies and other expendable property. 550.41 Federally owned property. 550.42 Intangible property. Procurement Standards 550.43 Purpose of procurement standards. 550.44 Cooperator responsibilities. 550.45 Standards of conduct. 550.46 Competition. 550.47 Cost and price analysis. 550.48 Procurement records. 550.49 Contract administration. 550.50 Contract provisions. Reports and Records 550.51 Purpose of reports and records. 550.52 Reporting program performance. 550.53 Financial reporting. 550.54 Invention disclosure and utilization reporting. 550.55 Retention and access requirements for records. Suspension, Termination and Enforcement 550.56 Purpose of suspension, termination, and enforcement. 550.57 Suspension and termination. 550.58 Enforcement. Subpart D—Close Out 550.59 Purpose. 550.60 Closeout procedures. 550.61 Subsequent adjustments and continuing responsibilities. 550.62 Collection of amounts due. Authority: Section 1472(b) of the National Agricultural Research, Extension, and Teaching Policy Act of 1977, as amended. (7 U.S.C 3318(b). Subpart A—General § 550.1 Purpose and scope. This Part establishes REE-wide standards of USDA's award and administration of non-assistance cooperative agreements executed under the authority of Section 1472(b) of the National Agricultural Research, Extension, and Teaching Policy Act of 1977, as amended. (7 U.S.C. 3318(b)). These agreements are neither procurement nor assistance in nature, and therefore, are not subject to the Federal Grant and Cooperative Agreements Act of 1977. Accordingly, proper use of these cooperative agreements will promote and facilitate partnerships between the REE Agency and the Cooperator in support of research, extension and education projects of mutual benefit to each party. § 550.2 Definitions. *Accrued expenditures* means the charges incurred by the Cooperator during a given period requiring the provision of funds for:
(1)Goods and other tangible property received;
(2)Services performed by employees, contractors, subrecipients, and other payees; and,
(3)Other amounts becoming owed under programs for which no current services or performance is required. *Acquisition cost of equipment* means the net invoice price of the equipment, including the cost of modifications, attachments, accessories, or auxiliary apparatus necessary to make the property usable for the purpose for which it was acquired. Other charges, such as the cost of installation, transportation, taxes, duty or protective in-transit insurance, shall be included or excluded from the unit acquisition cost in accordance with the Cooperator's regular accounting practices. *Advance* means a payment made to a Cooperator upon its request either before outlays are made by the Cooperator or through the use of predetermined payment schedules. *Authorized Departmental Officer (ADO)* means the REE Agency's official delegated authority to negotiate, award, administer, suspend, and terminate non-assistance cooperative agreements. *Authorized Departmental Officer's Designated Representative (ADODR)* means the REE Agency's technical representative, acting within the scope of delegated authority, who is responsible for participating with the Cooperator in the accomplishment of a cooperative agreement's objectives and monitoring and evaluating the Cooperator's performance. *Award* means a nonassistance cooperative agreement which provides money or in-kind services or property in lieu of money, to an eligible Cooperator. The term does not include: financial assistance awards in the form of grants, cooperative agreements, loans, loan guarantees, interest subsidies, or insurance; direct payments of any kind to individuals; and contracts which are required to be entered into and administered under procurement laws and regulations. *CFR* means the Code of Federal Regulations. *Closeout* means the process by which an REE Agency determines that all applicable administrative actions and all required work under the agreement have been completed by the Cooperator and REE Agency. *Contract* means a procurement contract entered into by the Cooperator or a subcontractor of the cooperator pursuant to the cooperative agreement. *Cooperator* means any State agricultural experiment station, State cooperative extension service, all colleges and universities, other research or education institutions and organizations, Federal and private agencies and organizations, individuals, and any other party, either foreign or domestic, receiving an award from an REE Agency. *Disallowed costs* means those charges incurred under the cooperative agreement that REE determines to be unallowable, in accordance with the applicable Federal cost principles or other terms and conditions contained in the cooperative agreement. *Electronic Funds Transfer (EFT)* means electronic payment methods used to transfer funds to a Cooperator's bank account. (Including HHS/PMS) *Equipment* means tangible nonexpendable personal property contributed or acquired by either an REE Agency or by the Cooperator, having a useful life of more than one year and an acquisition cost of $5000 or more per unit. However, consistent with Cooperator policy, lower limits may be established. *Funding period* means the period of time when Federal funding is available for obligation by the Cooperator. *HHS-PMS* means the Department of Health and Human Services/Payment Management System (also see EFT). *i-Edison* (Interagency Edison) is a database, which provides Federal grantee/Cooperator organizations and participating Federal agencies with the technology to electronically manage extramural invention portfolios in compliance with Federal reporting requirements. *Intangible property* means trademarks, copyrights, patents and patent applications. *Obligations* means the amounts of orders placed, contracts and grants awarded, services received and similar transactions during a given period that require payment by the Cooperator during the same or a future period. *OMB* means the Office of Management and Budget. *Outlays or expenditures* means charges made to the project or program. Outlays and expenditures also include cash disbursements for direct charges for goods and services, the amount of indirect expense incurred, the value of in-kind contributions applied, and the net increase (or decrease) in the amounts owed by the Cooperator for goods and other property received, for services performed by employees, contractors, subrecipients, and other payees and other amounts becoming owed under programs for which no current services or performance are required. *Peer Review* is a process utilized by REE Agencies to:
(1)Determine if agency sponsored research projects have scientific merit and program relevance;
(2)Provide peer input and make improvements to project design and technical approaches;
(3)Provide insight on how to conduct the highest quality research in support of Agency missions and programs. *Personal property* means property of any kind except real property. It may be tangible, having physical existence, or intangible, having no physical existence, such as copyrights, patents, or securities. *Principle Investigator (PI)* means the individual, designated by the Cooperator, responsible for directing and monitoring the performance, the day-to-day activities, and the scientific and technical aspects of the Cooperator's portion of an REE funded project. The PI works jointly with the ADODR in the development of project objectives and all other technical and performance related aspects of the program or project. See additional responsibilities of PI in § 550.32. *Prior approval* means written approval by an ADO evidencing prior consent. *Program income* means gross income earned by the Cooperator that is directly generated by a supported activity or earned as a result of the award. Program income includes, but is not limited to, income from fees for services performed, the use or rental of real or personal property acquired under federally funded projects, the sale of commodities or items fabricated under an award, and license fees and royalties on patents and copyrights. Program income does not include the receipt of principal on loans, rebates, credits, discounts, etc., or interest earned on any of them, or interest earned on advances of Federal funds. *Project costs* means all allowable costs, incurred by the Cooperator and the REE Agency toward the completion of the project. *Project period* means the period established in the cooperative agreement during which Federal contributions begin and end. *Property* means, unless otherwise stated, personal property, equipment, intangible property. *Publications* mean all types of paper based media including electronic and audio media. *Real property* means land, including land improvements, structures and appurtenances thereto, but excludes movable machinery and equipment. *REE Agency* means the USDA Agency that enters into a cooperative agreement with the cooperator. *State Cooperative Institutions* are defined in statute as institutions designated or receiving funds pursuant to:
(1)The First Morrill Act—The Land Grant Institutions.
(2)The Second Morrill Act—The 1890 Institutions.
(3)The Hatch Act of 1887—The State Agricultural Experiment Stations.
(4)The Smith-Lever Act—The State Extension Services.
(5)The McIntire-Stennis Act of 1962—The Cooperating Forestry Schools.
(6)Public Law 95-113, Section 1430—A college or university having an accredited college of veterinary medicine or a department of veterinary science or animal pathology or similar unit conducting animal health and disease research in a State Agricultural Experiment Station.
(7)Public Law 97-98, Section 1475b—Colleges, universities, and Federal laboratories having a demonstrated capacity in aquaculture research.
(8)Public Law 97-98, Section 1480—Colleges, universities, and Federal laboratories having a demonstrated capacity of rangeland research.
(9)Equity in Educational Land—Grant Status Act of 1994 (7 U.S.C. 301 note) 1994 Institutions. *Subaward* means an award in the form of money or in-kind services or property in lieu of money, made under an award by a Cooperator to an eligible subrecipient or by a subrecipient to a lower tier subrecipient. *Subrecipient* means the legal entity to which a subaward is made and which is accountable to the Cooperator for the use of the funds provided. The term may include foreign or international organizations (such as agencies of the United Nations) at the discretion of the REE Agency. *Supplies* means all personal property excluding equipment, intangible property, as defined in this section, and inventions of a contractor conceived or first actually reduced to practice in the performance of work under a funding agreement (“subject inventions”), as defined in 37 CFR Part 401, “Rights to Inventions Made by Nonprofit Organizations and Small Business Firms Under Government Grants, Contracts, and Cooperative Agreements.” *Suspension* means an action by a REE Agency that temporarily withdraws Federal sponsorship under an award, pending corrective action by the Cooperator or pending a decision to terminate the award by the REE Agency. Suspension of an award is a separate action from suspension under Federal Agency regulations implementing Executive Orders 12549 and 12689, “Debarment and Suspension.” *Termination* means the cancellation of Federal sponsorship, in whole or in part, under an agreement at any time prior to the date of completion. *Unliquidated obligations* are the amount of obligations incurred by the Cooperator for which an outlay has not been recorded. *Unobligated balance* means the portion of the funds authorized by the REE Agency that has not been obligated by the Cooperator and is determined by deducting the cumulative obligations from the cumulative funds authorized. *Unrecovered indirect cost* means the difference between the amount awarded and the amount, which could have been awarded under the Cooperator's approved negotiated indirect cost rate. *U.S.C.* means the United States Code. *USDA* means the United States Department of Agriculture. § 550.3 Applicability. This Part applies to all REE non-assistance cooperative agreements awarded under the authority of 7 U.S.C. 3318(b). § 550.4 Eligibility. REE agencies may enter into non-assistance cooperative agreements with State agricultural experiment stations, State cooperative extension services, all colleges and universities, other research or education institutions and organizations, Federal and private agencies and organizations, individuals, and any other party, either foreign or domestic, to further research, extension, or teaching programs in the food and agricultural sciences. (7 U.S.C. 3318(b)(1)). § 550.5 Competition. REE agencies may enter into non-assistance cooperative agreements, as authorized by this Part, without regard to any requirements for competition. (7 U.S.C. 3318(e)). § 550.6 Duration. REE may enter into non-assistance cooperative agreements for a period not to exceed five years. § 550.7 Exceptions. This Part does not apply to: USDA Federal Financial Assistance agreements subject to 7 CFR parts 3015, 3016, or 3019; Procurement contracts or other agreements subject to the Federal Acquisition Regulation
(FAR)or the Agriculture Acquisition Regulation (AgAR); or Agreements providing loans or insurance directly to an individual. § 550.8 Conflicting policies and deviations. This Part supersedes and takes precedence over any individual REE regulations and directives dealing with the award and administration of non-assistance cooperative agreements entered into under the delegated authority of 7 U.S.C. 3318(b). This Part may only be superseded, in whole or in part, by either a specifically worded statutory provision or a waiver authorized by the USDA-REE—Administrative and Financial Management (AFM)—Extramural Agreements Division
(EAD)or any successor organization. Responsibility for developing, interpreting, and updating this Part is assigned to the USDA-REE-AFM-EAD or any successor organization. § 550.9 Other applicable regulations. Related issuances are in other Parts of the CFR and the U.S.C. as follows:
(a)7 CFR Part 3017 “Governmentwide Debarment and Suspension”;
(b)7 CFR Part 3018 “New Restrictions on Lobbying”;
(c)7 CFR Part 3052 “Audits of States, Local Governments, and Nonprofit Organizations”;
(d)7 CFR 3015.175
(b)“Copyrights”;
(e)37 CFR 401.14 “Standard Patent Rights Clause”;
(f)15 U.S.C. 205a *et seq.* —“The Metric Conversion Act, as amended by the Omnibus Trade and Competitiveness Act”;
(g)42 U.S.C. 6962 “Resource Conservation and Recovery Act (RCRA)”. § 550.10 Special award conditions.
(a)REE Agencies may impose special conditions and/or additional requirements to a nonassistance agreement if a Cooperator:
(1)Has a history of poor performance,
(2)Is not financially stable,
(3)Has a management system that does not meet the standards prescribed in this Part,
(4)Has not conformed to the terms and conditions of a previous award, or
(5)Is not otherwise responsible.
(b)Special conditions and/or additional requirements may be added to an award provided that the Cooperator is notified in writing as to: the nature of the additional requirements, the reason why the additional requirements are being imposed, the nature of the corrective action needed, the time allowed for completing the corrective actions, and the method for requesting reconsideration of the additional requirements imposed. Any special conditions shall be promptly removed once the conditions that prompted them have been corrected. Subpart B—Formation of Agreements § 550.11 Purpose. Sections 12 through 18 prescribe instructions and other pre-award matters to be used in establishing a non-assistance cooperative agreement. § 550.12 Statutory authorization required (REE Agency). REE Agencies must have programmatic statutory authority for the proposed project prior to entering into any non-assistance cooperative agreement. § 550.13 Mutuality of interest. The REE Agency shall document both parties' interest in the project. Mutual interest exists when both parties benefit in the same qualitative way from the objectives of the agreement. If one party to the agreement would independently have an interest in the project, which is shared by the other party, and both parties' pool resources to obtain the end result of the project, mutual interest exists. § 550.14 Indirect cost/tuition remission.
(a)Indirect Cost:
(1)State Cooperative Institutions. Payment of indirect costs to State Cooperative Institutions in connection with non-assistance cooperative agreements awarded under the authority of 7 U.S.C. 3318(b) is prohibited. This prohibition does not apply to funds for international agricultural programs conducted by a State cooperative institution and administered by the Secretary or to funds provided by a Federal agency for such cooperative program or project through a fund transfer, advance or reimbursement. (7 U.S.C. 3319)
(2)Non-Profit Organizations: Payment of indirect costs to non-profit institutions in connection with USDA cooperative agreement, under the authority of 7 U.S.C. 3318(b), is limited to 10 percent of the total direct cost of the project. (Annual Appropriations Bill for Agriculture and Related agencies, General Provisions)
(3)All other cooperating organizations: With the exception of §§ 550.14(a)(1) and 550.14(a)(2), above, payment of indirect costs is allowable in connection with REE non-assistance cooperative agreements. Reimbursement of indirect costs is limited to the percentage(s) established in the Cooperator's negotiated indirect cost rate schedule.
(4)In any case, the REE Agency shall not reimburse indirect costs prior to receipt of the Cooperator's negotiated indirect cost rate schedule.
(b)Tuition Remission.
(1)State Cooperative Institutions. Reimbursement of tuition expenses to State Cooperative Institutions in connection with REE non-assistance cooperative agreements is prohibited. (7 U.S.C 3319)
(2)All other cooperating organizations: Except for § 550.14(b)(1), tuition remission is an allowable expense as determined in accordance with the cost principles applicable to the Cooperator. REE agencies shall negotiate and approve such payments as related to the scope and objectives of the non-assistance agreement. § 550.15 Resource contribution. Each party must contribute resources towards the successful completion of the project. Required resource contributions must be substantial enough to substantiate a true stake in the project as determined by the ADO.
(a)REE Agency's Contribution.
(1)The REE Agency's contribution must consist of the total in-house costs to the REE Agency and the total amount to be reimbursed by the REE Agency to the Cooperator for all allowable costs agreed to in advance as reflected in the cooperative agreement.
(b)Cooperator's Contribution.
(1)The Cooperator's contribution must be no less than 20 percent of the total of the resource contributions under the cooperative agreement. Resource contributions of the Cooperator must consist of a sufficient amount of itemized direct costs to substantiate a true stake in the project as determined by the ADO. The Cooperator's contribution must be maintained at 20 percent of Federal funding throughout the life of the cooperative agreement.
(2)Cooperators share of contributions may consist of “in-kind” contributions and may also include unrecoverable indirect costs. Such costs may be accepted as part of the Cooperator's resource contribution when all of the following criteria are met:
(i)Costs are verifiable from the Cooperator's records.
(ii)Costs are not included as contributions for any other federally assisted project or program.
(iii)Costs are necessary and reasonable for proper and efficient accomplishment of project or program objectives.
(iv)Costs are allowable under the applicable cost principles.
(v)Costs are not paid by the Federal Government under another award, except where authorized by Federal statute to be used for cost sharing or matching.
(vi)Costs conform to other provisions of this Part, as applicable.
(3)Volunteer services furnished by professional and technical personnel, consultants, and other skilled and unskilled labor may be counted as resource contributions if the service is an integral and necessary part of an approved project or program. Rates for volunteer services shall be consistent with those paid for similar work in the Cooperator's organization. In those instances in which the required skills are not found in the Cooperator organization, rates shall be consistent with those paid for similar work in the labor market in which the Cooperator competes for the kind of services involved. In either case, paid fringe benefits that are reasonable, allowable, and allocable may be included in the valuation.
(4)When an employer other than the Cooperator furnishes the services of an employee, these services shall be valued at the employee's regular rate of pay (plus an amount of fringe benefits that are reasonable, allowable, and allocable, but exclusive of overhead costs), provided these services are in the same skill for which the employee is normally paid.
(5)Donated supplies may include such items as expendable equipment, office supplies, laboratory supplies or workshop and classroom supplies. Value assessed to donated supplies included in the cost sharing or matching share shall be reasonable and shall not exceed the fair market value of the property at the time of the donation.
(6)The value of donated property shall be determined in accordance with the usual accounting policies of the Cooperator, with the following qualifications.
(i)The value of donated land and buildings shall not exceed its fair market value at the time of donation to the Cooperator as established by an independent appraiser (e.g., certified real property appraiser or General Services Administration representative) and certified by a responsible official of the Cooperator.
(ii)The value of donated equipment shall not exceed the fair market value of equipment of the same age and condition at the time of donation.
(iii)The value of donated space shall not exceed the fair rental value of comparable space as established by an independent appraisal of comparable space and facilities in a privately owned building in the same locality.
(iv)The value of loaned equipment shall not exceed its fair rental value.
(v)The following requirements pertain to the Cooperator's supporting records for in-kind contributions from third parties.
(A)Volunteer services shall be documented and, to the extent feasible, supported by the same methods used by the Cooperator for its own employees.
(B)The basis for determining the valuation for personal service, material, equipment, buildings, and land shall be documented. § 550.16 Project Development. REE provides partial funding to Cooperators to support research projects that contribute to REE program objectives and help carry out the REE mission. The Cooperator's PI and the REE Agency's ADODR shall jointly develop the following documentation:
(a)Project Plan—A plan that shall be jointly developed by the REE ADODR and the Cooperator that is compliant with an REE program requirement. The project plan will utilize the REE provided format for external peer review.
(b)Statement of Work—A detailed statement of work shall be jointly planned, developed and prepared by the Cooperator's PI and the awarding Agency's ADODR consisting of the following:
(1)Objective
(2)Approach
(3)Statement of Mutual Interest
(4)Performance Responsibilities
(5)Mutual Agreements
(c)Budget—A plan that shall be jointly developed by the REE ADODR and the Cooperator PI outlining the following resource contributions:
(1)Total amount to be reimbursed by the REE Agency to the Cooperator. (Direct and Indirect Costs as applicable)
(2)Total in-house costs to the REE Agency. (Direct and indirect costs)
(3)Total in-house costs to the Cooperator. (Direct and indirect costs) § 550.17 Peer review. Upon request of the REE Agency, cooperators may be requested to provide documentation in support of peer review activities and cooperator personnel may be requested to participate in peer review forums to assist the REE Agency in their reviews. § 550.18 Assurances/certifications.
(a)Governmentwide Debarment and Suspension (Non procurement)—7 CFR part 3017;
(b)Governmentwide requirements for Drug-Free Workplace—7 CFR part 3021;
(c)Non-discrimination. The Cooperator assures compliance with the following requirement: No person in the United States shall, on the grounds of race, color, national origin, sex, age, religion, political beliefs, or disability, be excluded from participation in, be denied the benefits of, or be otherwise subjected to discrimination under any project or activity under a non-assistance cooperative agreement.
(d)Protection of Human Subjects Requirements: The Cooperator assures compliance with the following provisions regarding the rights and welfare of human subjects:
(1)The Cooperator is responsible for safeguarding the rights and welfare of any human subjects involved in research, development, and related activities supported by this Agreement. The Cooperator may conduct research involving human subjects only as prescribed in the statement of work and as approved by the Cooperator's Cognizant Institutional Review Board. Prior to conducting such research, the Cooperator shall obtain and document a legally sufficient informed consent from each human subject involved. No such informed consent shall include any exculpatory language through which the subject is made to waive, or to appear to waive, any of his or her legal rights, including any release of the Cooperator or its agents from liability for negligence.
(2)The Cooperator agrees to comply with U.S. Department of Health and Human Services' regulations regarding human subjects, appearing in 45 CFR Part 46 (as amended).
(3)It will comply with REE policy, which is to assure that the risks do not outweigh either potential benefits to the subjects or the expected value of the knowledge sought.
(4)Selection of subject or groups of subjects shall be made without regard to sex, race, color, religion, or national origin unless these characteristics are factors to be studied.
(e)Animal Welfare Act Requirements: The Cooperator assures compliance with the Animal Welfare Act, as amended, 7 U.S.C. 2131, *et seq.* , and the regulations promulgated thereunder by the Secretary of Agriculture (9 CFR, Subchapter A) pertaining to the care, handling, and treatment of warm-blooded animals held or used for research, teaching, or other activities supported by Federal funds. The Cooperator may request registration of facilities and a current listing of licensed dealers from the Regional Office of the Animal and Plant Health Inspection Service (APHIS), USDA, for the Region in which their facility is located. The location of the appropriate APHIS Regional Office, as well as information concerning this requirement, may be obtained by contacting the Senior Staff Officer, Animal Care Staff, USDA/APHIS, 4700 River Road, Riverdale, Maryland 20737.
(f)Recombinant DNA Research Requirements: The Cooperator assures that it will assume primary responsibility for implementing proper conduct on recombinant DNA research and it will comply with the National Institute of Health Guidelines for Recombinant DNA Research, as revised.
(1)If the Cooperator wishes to send or receive registered recombinant DNA material which is subject to quarantine laws, permits to transfer this material into the U.S. or across state lines may be obtained by contacting USDA/APHIS/PPQ, Scientific Services-Biotechnology Permits, 4700 River Road, Unit 133, Riverdale, Maryland 20737. In the event that the Cooperator has not established the necessary biosafety committee, a request for guidance or assistance may be made to the USDA Recombinant DNA Research Officer.
(g)Agriculture Bioterrorism Protection Act Requirements: The Cooperator assures compliance with the Agriculture Bioterrorism Protection Act of 2002, as implemented at 7 CFR Part 331 and 9 CFR Part 121, by agreeing that it will not possess, use, or transfer any select agent or toxin without a certificate of registration issued by the Agency. Subpart C—Management of Agreements Financial Management § 550.19 Purpose. Sections 550.20 through 550.25 of this subpart prescribe standards for financial management systems and program management requirements. § 550.20 Standards for financial management systems.
(a)REE agencies shall require Cooperators to relate financial data to performance data.
(b)Cooperators' financial management systems shall provide for the following.
(1)Accurate, current, and complete disclosure of the financial results of each REE sponsored project or program in accordance with the reporting requirements set forth in § 550.53 of this part. REE requires financial reporting on an accrual basis; however, the Cooperator shall not be required to establish an accrual accounting system. These Cooperators shall develop such accrual data through best estimated for their reports on the basis of an analysis of the documentation on hand.
(2)Records that identify the source and application of funds for federally sponsored activities. These records shall contain information pertaining to Federal awards, authorizations, obligations, unobligated balances, assets, outlays, income and interest.
(3)Effective control over and accountability for all funds, property and other assets. Cooperators shall adequately safeguard all such assets and assure they are used solely for authorized purposes.
(4)Comparison of outlays with budget amounts for each award. Whenever appropriate, financial information should be related to performance and unit cost data.
(5)Written procedures to minimize the time elapsing between the transfer of funds to the Cooperator from the U.S. Treasury and the issuance or redemption of a check, warrant or payment by other means for program purposes by the Cooperator. To the extent that the provisions of the Cash Management Improvement Act
(CMIA)(Pub. L. 101-453) govern, payment methods of State agencies, instrumentalities, and fiscal agents shall be consistent with CMIA Treasury-State Agreements or the CMIA default procedures codified at 31 CFR Part 205, “Rules and procedures for efficient Federal State funds transfer.”
(6)Written procedures for determining the reasonableness, allocability and allowability of costs in accordance with the provisions of the applicable Federal cost principles and the terms and conditions of the award.
(7)Accounting records including cost accounting records that are supported by source documentation.
(c)Where bonds are required in the situations described above, the bonds shall be obtained from companies holding certificates of authority as acceptable sureties, as prescribed in 31 CFR Part 223, “Surety Companies Doing Business with the United States.” § 550.21 Funding availability. The funding period will begin on the date of final signature, unless otherwise stated on the agreement, and continue for the project period specified on the cover page of the cooperative agreement. § 550.22 Payment.
(a)Payment methods shall minimize the time elapsing between the transfer of funds from the U.S. Treasury and the issuance or redemption of a check, warrant, or payment by other means by the Cooperators. Payment methods of State agencies or instrumentalities shall be consistent with Treasury-State CMIA agreements or default procedures codified at 31 CFR Part 205.
(b)Reimbursement is the preferred method of payment. All payments to the Cooperator shall be made via EFT.
(1)When the reimbursement method is used, the REE Agency shall make payment within 30 days after receipt of the billing, unless the billing is improper.
(2)Cooperators shall be authorized to submit requests for payment not more than quarterly and not less frequently than annually.
(3)Content of Invoice. At a minimum, the Cooperator's invoice shall state the following:
(i)The name and address of the Cooperator;
(ii)The name and address of the PI;
(iii)The name and address of the financial officer to whom payments shall be sent;
(iv)A reference to the cooperative agreement number;
(v)The invoice date;
(vi)The time period covered by the invoice; and
(vii)Total dollar amount itemized by budget categories (labor, direct costs, and indirect costs, etc).
(4)To facilitate the EFT process, the Cooperator shall provide the following information:
(i)The name, addresses, and telephone number of the financial institution receiving payment;
(ii)The routing transit number of the financial institution receiving payment;
(iii)The account to which funds are to be deposited; and
(iv)The type of depositor account (checking or savings).
(c)If the REE Agency has determined that reimbursement is not feasible because the Cooperator lacks sufficient working capital, the REE Agency may provide cash on an advance basis provided the Cooperator maintains or demonstrates the willingness to maintain:
(1)Written procedures that minimize the time elapsing between the transfer of funds and disbursement by the Cooperator, and
(2)financial management systems that meet the standards for fund control and accountability as established in § 550.20. Under this procedure, the REE Agency shall advance cash to the Cooperator to cover its estimated disbursement needs for an initial period. The timing and amount of cash advances shall be as close as is administratively feasible to the actual disbursements by the Cooperator organization for direct program or project costs and the proportionate share of any allowable indirect costs.
(1)Advance payment mechanisms include, but are not limited to, Treasury check and electronic funds transfer.
(2)Advance payment mechanisms are subject to the requirements of 31 CFR Part 205.
(3)Requests for advance payment shall be submitted on SF-270, “Request for Advance or Reimbursement.” This form is not to be used when advance payments are made to the Cooperator automatically through the use of a predetermined payment schedule or if precluded by special REE Agency instructions for electronic funds transfer.
(4)Cooperators shall maintain advances of Federal funds in interest bearing accounts, unless § 550.22(c)(4)(i), (ii), or
(iii)applies.
(i)The Cooperator receives less than $120,000 in Federal awards per year.
(ii)The best reasonably available interest bearing account would not be expected to earn interest in excess of $250 per year on Federal cash balances.
(iii)The depository would require an average or minimum balance so high that it would not be feasible within the expected Federal and non-Federal cash resources.
(5)For those entities where CMIA and its implementing regulations do not apply, interest earned on Federal advances deposited in interest bearing accounts shall be remitted annually to Department of Health and Human Services, Payment Management System, Rockville, MD 20852. The Cooperator for administrative expense may retain interest amounts up to $250 per year. State universities and hospitals shall comply with CMIA, as it pertains to interest. If an entity subject to CMIA uses its own funds to pay pre-award costs for discretionary awards without prior written approval from the REE Agency, it waives its right to recover the interest under CMIA. Thereafter, the REE Agency shall reimburse the Cooperator for its actual cash disbursements.
(6)Whenever possible, advances shall be consolidated to cover anticipated cash needs for all awards made by the REE Agency to the Cooperator. The working capital advance method of payment shall not be used for Cooperators unwilling or unable to provide timely advances to their subrecipient to meet the subrecipient's actual cash disbursements.
(d)To the extent available, Cooperators shall disburse funds available from repayments to and interest earned on program income, rebates, refunds, contract settlements, audit recoveries and interest earned on such funds before requesting additional cash payments.
(e)Unless otherwise required by statute, REE Agencies shall not withhold payments for proper charges made by Cooperators at any time during the project period unless
(1)or
(2)apply.
(1)A Cooperator has failed to comply with the project objectives, the terms and conditions of the award, or REE reporting requirements.
(2)The Cooperator owes a debt to the United States which is subject to offset pursuant to 7 CFR Part 3 and Federal Clause Collection Standard; 31 CFR Parts 901-904.
(f)Standards governing the use of banks and other institutions as depositories of funds advanced or reimbursed under awards are as follows.
(1)Except for situations described in § 550.22(f)(2), REE Agencies shall not require separate depository accounts for funds provided to a Cooperator or establish any eligibility requirements for depositories for funds provided to a Cooperator. However, Cooperators must be able to account for the receipt, obligation and expenditure of funds.
(2)Advances of Federal funds shall be deposited and maintained in insured accounts whenever possible. § 550.23 Program income.
(a)REE Agencies shall apply the standards set forth in this section in requiring Cooperator organizations to account for program income related to projects financed in whole or in part with Federal funds.
(b)Except as provided in § 550.23(f), program income earned during the project period shall be retained by the Cooperator and shall be added to funds committed to the project by the REE Agency and Cooperator and used to further eligible project or program objectives.
(c)Cooperators shall have no obligation to the Federal Government regarding program income earned after the end of the project period.
(d)Costs incident to the generation of program income may be deducted from gross income to determine program income, provided these costs have not been charged to the award.
(e)Proceeds from the sale of property shall be handled in accordance with the requirements of the Property Standards (See §§ 550.36 through 550.42).
(f)Cooperators shall have no obligation to the Federal Government with respect to program income earned from license fees and royalties for copyrighted material, patents, patent applications, trademarks, and inventions produced under an award. However, Patent and Trademark Amendments (35 U.S.C. Chapter 25) apply to inventions made under an experimental, developmental, or research award. § 550.24 Non-Federal audits.
(a)Cooperators and subrecipients that are institutions of higher education or other non-profit organizations (including hospitals) shall be subject to the audit requirements contained in the Single Audit Act Amendments of 1996 (31 U.S.C. 7501-7507) and revised OMB Circular A-133, “Audits of States, Local Governments, and Non-Profit Organizations.”
(b)State and local governments shall be subject to the audit requirements contained in the Single Audit Act Amendments of 1996 (31 U.S.C. 7501-7507) and revised OMB Circular A-133, “Audits of States, Local Governments, and Non-Profit Organizations.”
(c)For-profit hospitals not covered by the audit provisions of revised OMB Circular A-133 shall be subject to the audit requirements of the REE agencies.
(d)Commercial organizations shall be subject to the audit requirements of the REE Agency or the prime recipient as incorporated into the award document. § 550.25 Allowable costs. For each kind of Cooperator, there is a set of Federal principles for determining allowable costs. Allowability of costs shall be determined in accordance with the cost principles applicable to the entity incurring the costs. Thus, allowability of costs incurred by State, local or federally recognized Indian tribal governments is determined in accordance with the provisions of OMB Circular A-87, “Cost Principles for State, Local, and Indian Tribal Governments” codified at 2 CFR Part 225. The allowability of costs incurred by non-profit organizations is determined in accordance with the provisions of OMB Circular A-122, “Cost Principles for Non-Profit Organizations” codified at 2 CFR Part 230. The allowability of costs incurred by institutions of higher education is determined in accordance with the provisions of OMB Circular A-21, “Cost Principles for Educational Institutions” codified at 2 CFR part 220. The allowability of costs incurred by hospitals is determined in accordance with the provisions of Subpart E of 45 CFR Part 74. The allowability of costs incurred by commercial organizations and those non-profit organizations listed in Appendix C to Circular A-122 (2 CFR part 230) is determined in accordance with the contract cost principles and procedures of the Federal Acquisition Regulation
(FAR)at 48 CFR Part 31. Program Management § 550.26 Monitoring program performance.
(a)Cooperators are responsible for managing the day-to-day operations of REE nonassistance awards using their established controls and policies, as long as they are consistent with REE requirements. However, in order to fulfill their role in regard to the stewardship of Federal funds, REE Agencies monitor their agreements to identify potential problems and areas where technical assistance might be necessary. This active monitoring is accomplished through review of reports and correspondence from the cooperator, audit reports, site visits, and other information available to the REE Agency. It is the responsibility of the Cooperator to ensure that the project is being performed in compliance with the terms and conditions of the award.
(b)Monitoring of a project or activity will continue for as long as the REE Agency retains a financial interest in the project or activity. REE agencies reserve the right to monitor a project after it has been administratively closed out and no longer providing active support in order to resolve issues of accountability and other administrative requirements. Additional requirements regarding reporting and program performance can be found in §§ 550.51 through 550.55 of this part.
(c)The REE Agency reserves the right to perform site visits at Cooperator locations. Access to project or program records shall be provided in accordance with the provisions of § 550.55 “Retention and access requirements for records.” § 550.27 Prior approvals.
(a)The budget is the financial expression of the project or program as approved during the award process. REE agencies require that all Federal costs be itemized on the approved budget. The budget shall be related to performance for program evaluation purposes.
(b)Cooperators are required to report deviations from budget and program plans, and request prior approvals for budget and program plan revisions.
(c)Cooperators shall request prior approvals from REE Agencies for one or more of the following program or budget related reasons.
(1)Incur pre-award costs up to 90 days prior to award date. All pre-award costs are incurred at the Cooperator's risk (i.e., the REE Agency is under no obligation to reimburse such costs if for any reason the Cooperator does not receive an award or if the award is less than anticipated and inadequate to cover such costs).
(2)Change in the scope or the objective of the project or program (even if there is no associated budget revision requiring prior written approval).
(3)The absence for more than three months, or a 25 percent reduction in time devoted to the project, by the approved project director or principal investigator.
(4)Extensions of time, within statutory limitations, to complete project objectives. This extension may not be requested merely for the purpose of using unobligated balances. The Cooperator shall request the extension in writing with supporting reasons.
(5)The transfer of amounts budgeted for indirect costs to absorb increases in direct costs, or vice versa.
(6)The inclusion of costs that require prior approval in accordance with OMB Circular A-21, “Cost Principles for Educational Institutions,” (2 CFR Part 220), OMB Circular A-122, “Cost Principles for Non-Profit Organizations” (2 CFR Part 230) or 45 CFR Part 74 Appendix E, or 48 CFR Part 31, “Contract Cost Principles and Procedures,” as applicable.
(7)Unless described in the agreement and funded in the approved awards, the sub award, transfer or contracting out of any work under an award. This provision does not apply to the purchase of supplies, material, equipment or general support services.
(d)When requesting approval for budget revisions, Cooperators shall use the budget form used in the cooperative agreement.
(e)Within 30 calendar days from the date of receipt of the request for budget revisions, the ADO shall review the request and notify the Cooperator whether the budget revisions have been approved. § 550.28 Publications and Acknowledgment of Support.
(a)Publications. REE Agencies and the Federal Government shall enjoy a royalty-free, nonexclusive, and irrevocable right to reproduce, publish or otherwise use, and to authorize others to use, any materials developed in conjunction with a nonassistance cooperative agreement or contract under such an agreement. (b)(1) Cooperators shall acknowledge ARS, Economics Research Service (ERS), National Agricultural Statistics Service (NASS), and the Cooperative State Research, Education, and Extension Service (CSREES) support, whether cash or in-kind, in any publications written or published with Federal support and, if feasible, on any publication reporting the results of, or describing, a Federally supported activity as follows: “This material is based upon work supported by the U.S. Department of Agriculture, (insert Agency name) under Agreement No. (Cooperator should enter the applicable agreement number here).”
(2)All such material must also contain the following disclaimer unless the publication is formally cleared by the awarding agency: “Any opinions, findings, conclusion, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the U.S. Department of Agriculture.”
(3)Any public or technical information related to work carried out under a non-assistance cooperative agreement shall be submitted by the developing party to the other for advice and comment. Information released to the public shall describe the contributions of both parties to the work effort. In the event of a dispute, a separate publication may be made with effective statements of acknowledgment and disclaimer.
(c)Media. Cooperators shall acknowledge awarding Agency support, as indicated in § 550.28
(b)above, in any form of media (print, DVD, audio production, etc.) produced with Federal support that has a direct production cost to the Cooperator of over $5,000. Unless the terms of the Federal award provide otherwise, this requirement does not apply to:
(1)Media produced under mandatory or formula grants or under sub awards.
(2)Media produced as research instruments or for documenting experimentation or findings and intended for presentation or distribution to a USDA/REE audience. § 550.29 Press Releases. Press releases or other forms of public notification will be submitted to the REE agency for review prior to release to the public. The REE Agency will be given the opportunity to review, in advance, all written press releases and any other written information to be released to the public by the Cooperator, and require changes as deemed necessary, if the material mentions by name the REE Agency or the USDA, or any USDA employee or research unit or location. § 550.30 Advertising. The Cooperator will not refer in any manner to the USDA or agencies thereof in connection with the use of the results of the project without prior specific written authorization by the awarding Agency. Information obtained as a result of the project will be made available to the public in printed or other forms by the awarding Agency at its discretion. The Cooperator will be given due credit for its cooperation in the project. Prior approval is required. § 550.31 Questionnaires and survey plans. The Cooperator is required to submit to the REE Agency copies of questionnaires and other forms for clearance in accordance with the Paperwork Reduction Act of 1980 and 5 CFR part 1320. § 550.32 Project supervision and responsibilities.
(a)The Cooperator is responsible and accountable for the performance and conduct of all Cooperator employees assigned to the project. The REE Agency does not have authority to supervise Cooperator employees or engage in the employer employee relationship.
(b)The PI shall:
(1)Work jointly with the ADODR in the development of the project statement of work;
(2)Work jointly with the ADODR in the development of the project budget;
(3)Report, and obtain approval for, any change in the project budget;
(4)Report, and obtain approval for, any change in the scope or objectives of the project;
(5)Assure that technical project performance and financial status reports are submitted on a timely basis in accordance with the terms and conditions of the award;
(6)Advise the ADODR of any issues that may affect the timely completion of the project;
(7)Assure that the Cooperator meets its commitments under the terms and conditions of the non-assistance agreement;
(8)Assure that appropriate acknowledgements of support are included in all publications, in accordance with § 550.28 of this Part.
(9)Assure that inventions are appropriately reported in accordance with § 550.54 of this Part; and
(10)Upon request, provide the REE Agency with a project plan for use in for external peer review. § 550.33 Administrative supervision. REE employees are prohibited from engaging in matters related to cooperator employer/employee relations such as personnel, performance and time management issues. The cooperator is solely responsible for the administrative supervision of its employees. § 550.34 Research misconduct.
(a)The Cooperator bears the primary responsibility for prevention and detection of research misconduct and for the inquiry, investigation and adjudication of research misconduct alleged to have occurred in association with their own institution.
(b)The Cooperator shall:
(1)Maintain procedures for responding to allegations or instances of research misconduct that has the following components:
(i)Objectivity
(ii)Due process
(iii)Whistle blower protection
(iv)Confidentiality
(v)Timely resolution;
(2)Promptly conduct an inquiry into any allegation of research misconduct;
(3)Conduct an investigation if an inquiry determines that the allegation or apparent instance of research misconduct has substance;
(4)Provide appropriate separation of responsibilities between those responsible for inquiry and investigation, and those responsible for adjudication;
(5)Advise REE Agency of outcome at end of inquiries and investigations into allegations or instances of research misconduct; and
(6)Upon request, provide the REE Agency, upon request, hard copy (or Web site address) of their policies and procedures related to research misconduct.
(c)Research misconduct or allegations of research misconduct shall be reported to the USDA Research Integrity Officer
(RIO)and/or to the USDA, Office of Inspector General
(OIG)Hotline.
(1)The USDA RIO can be reached at: USDA Research Integrity Officer, 214-W Whitten Building, Washington, DC 20250, Telephone: 202-720-5923, E-mail: *researchintegrity@usda.gov.*
(2)The USDA OIG Hotline can be reached on: 1-800-424-9121. § 550.35 Rules of the workplace. Cooperator employees, while engaged in work at the REE Agency's facilities, will abide by the Agency's standard operating procedures regarding the maintenance of laboratory notebooks, dissemination of information, equipment operation standards, hours of work, conduct, and other incidental matters stated in the rules and regulations of the Agency. Equipment/Property Standards § 550.36 Purpose of equipment/property standards. Sections 550.37 through 550.42 of this part set forth uniform standards governing management and disposition of property furnished by the Federal Government or acquired by the Cooperator with funds provided by the Federal Government. The Cooperator may use its own property management standards and procedures provided it observes other applicable provisions of this Part. § 550.37 Title to equipment.
(a)As authorized by 7 U.S.C. 3318(d), title to expendable and nonexpendable equipment, supplies, and other tangible personal property purchased with Federal funding in connection with a non assistance cooperative agreement shall vest in the Cooperator from date of acquisition unless otherwise stated in the cooperative agreement.
(b)Notwithstanding any other provision of this rule the REE Agency may, at its discretion, retain title to equipment described in Paragraph
(a)of this section that is or may be purchased with Federal funds when the REE agency determines that it is in the best interest of the Federal government. § 550.38 Equipment.
(a)The Cooperator shall not use equipment acquired with Federal funds to provide services to non-Federal outside organizations for a fee that is less than private companies charge for equivalent services, unless specifically authorized by Federal statute, for as long as the Federal Government retains an interest in the equipment.
(b)The Cooperator shall use the equipment in the project or program for which it was acquired as long as needed, whether or not the project or program continues to be supported by Federal funds and shall not encumber the property without approval of the REE Agency. When no longer needed for the original project or program, the Cooperator shall use the equipment in connection with its' other federally-sponsored activities, in the following order of priority:
(a)Activities sponsored by the REE Agency which funded the original project, then
(b)activities sponsored by other Federal awarding agencies.
(c)During the time that equipment is used on the project or program for which it was acquired, the Cooperator shall make it available for use on other projects or programs if such other use will not interfere with the work on the project or program for which the equipment was originally acquired as may be determined by the REE Agency. First preference for such other use shall be given to other projects or programs sponsored by the REE Agency that financed the equipment; second preference shall be given to projects or programs sponsored by other Federal awarding agencies. If equipment is owned by the Federal Government, use on other activities not sponsored by the Federal Government shall be permissible if authorized by the REE Agency. User charges shall be treated as program income.
(d)When acquiring replacement equipment, unless otherwise directed by the REE Agency, the Cooperator shall use the equipment to be replaced as trade-in or sell the equipment and use the proceeds to offset the costs of the replacement equipment subject to the approval of the REE Agency.
(e)The Cooperator's property management standards for equipment acquired with Federal funds and federally owned equipment shall include all of the following.
(1)Equipment records shall be maintained accurately and shall include the following information:
(i)A description of the equipment;
(ii)Manufacturer's serial number, model number, Federal stock number, national stock number, or other identification number;
(iii)Source of the equipment, including the award number;
(iv)Whether title vests in the Cooperator or the Federal Government;
(v)Acquisition date (or date received, if the equipment was furnished by the Federal Government) and cost;
(vi)Information from which one can calculate the percentage of Federal participation in the cost of the equipment (not applicable to equipment furnished by the Federal Government);
(vii)Location and condition of the equipment and the date the information was reported;
(viii)Unit acquisition cost; and
(ix)Ultimate disposition data, including date of disposal and sales price or the method used to determine current fair market value where a Cooperator compensates the REE Agency for its share.
(2)Equipment owned by the Federal Government shall be identified to indicate Federal ownership.
(3)A physical inventory of equipment shall be taken and the results reconciled with the equipment records at least once every two years and a copy provided to the ADO responsible for the agreement. Any differences between quantities determined by the physical inspection and those shown in the accounting records shall be investigated to determine the causes of the difference. The Cooperator shall, in connection with the inventory, verify the existence, current utilization, and continued need for the equipment.
(4)A control system shall be in effect to insure adequate safeguards to prevent loss, damage, or theft of the equipment. Any loss, damage, or theft of equipment shall be investigated and fully documented. If the Federal Government owns the equipment, the Cooperator shall promptly notify the REE Agency.
(5)Adequate maintenance procedures shall be implemented to keep the equipment in good condition.
(6)Where the Cooperator is authorized or required to sell the equipment, proper sales procedures shall be established which provide for competition to the extent practicable and result in the highest possible return.
(f)When the Cooperator no longer needs the equipment, the equipment shall be used for other activities in accordance with the following standards. For equipment with a current per unit fair market value of $5000 or more, the Cooperator may retain the equipment for other uses provided that compensation is made to the original REE Agency or its successor. The amount of compensation shall be computed by applying the percentage of Federal participation in the cost of the original project or program to the current fair market value of the equipment. If the Cooperator has no need for the equipment, the Cooperator shall request disposition instructions from the REE Agency. The REE Agency shall determine whether the equipment can be used to meet the Agency's requirements. If no requirement exists within that Agency, the availability of the equipment shall be reported to the General Services Administration
(GSA)by the REE Agency to determine whether a requirement for the equipment exists in other Federal agencies. The REE Agency shall issue instructions to the Cooperator no later than 120 calendar days after the Cooperator's request and the following procedures shall govern.
(1)If so instructed or if disposition instructions are not issued within 120 calendar days after the Cooperator's request, the Cooperator shall sell the equipment and reimburse the REE Agency an amount computed by applying to the sales proceeds the percentage of Federal participation in the cost of the original project or program. However, the Cooperator shall be permitted to deduct and retain from the Federal share $500 or ten percent of the proceeds, whichever is less, for the Cooperator's selling and handling expenses.
(2)If the Cooperator is instructed to ship the equipment elsewhere, the Cooperator shall be reimbursed by the Federal Government by an amount which is computed by applying the percentage of the Cooperator's participation in the cost of the original project or program to the current fair market value of the equipment, plus any reasonable shipping or interim storage costs incurred.
(3)If the Cooperator is instructed to otherwise dispose of the equipment, the Cooperator shall be reimbursed by the REE Agency for such costs incurred in its disposition.
(4)The REE Agency may reserve the right to transfer the title to the Federal Government or to a third party named by the Federal Government when such third party is otherwise eligible under existing statutes. Such transfer shall be subject to the following standards.
(i)The equipment shall be appropriately identified in the award or otherwise made known to the Cooperator in writing.
(ii)The REE Agency shall issue disposition instructions within 120 calendar days after receipt of a final inventory. The final inventory shall list all equipment acquired with Federal funds and federally owned equipment. If the REE Agency fails to issue disposition instructions within the 120 calendar days, the Cooperator shall apply the standards of this section, as appropriate.
(iii)When the REE Agency exercises its right to take title, the equipment shall be subject to the provisions for federally owned equipment. § 550.39 Equipment replacement insurance. If required by the terms and conditions of the award, the Cooperator shall provide adequate insurance coverage for replacement of equipment acquired with Federal funds in the event of loss or damage to such equipment. § 550.40 Supplies and other expendable property.
(a)Title to supplies and other expendable property shall vest in the Cooperator upon acquisition. If there is a residual inventory of unused supplies exceeding $5000 in total aggregate value upon termination or completion of the project or program and the supplies are not needed for any other federally-sponsored project or program, the Cooperator shall retain the supplies for use on non-Federal sponsored activities or sell them, but shall, in either case, compensate the Federal Government for its share. The amount of compensation shall be computed in the same manner as for equipment.
(b)The Cooperator shall not use supplies acquired with Federal funds to provide services to non-Federal outside organizations for a fee that is less than private companies charge for equivalent services, unless specifically authorized by Federal statute as long as the Federal Government retains an interest in the supplies. § 550.41 Federally-owned property. Title to federally-owned property remains vested in the Federal Government. Cooperators shall submit annually an inventory listing of federally-owned property in their custody to the REE Agency. Upon completion of the award or when the property is no longer needed, the Cooperator shall report the property to the REE Agency for further Federal Agency utilization. If the REE Agency has no further need for the property, it shall be declared excess and reported to the GSA, unless the REE Agency has statutory authority to dispose of the property by alternative methods ( *e.g.* , the authority provided by the Federal Technology Transfer Act (15 U.S.C. 3710 (i)) to donate research equipment to educational and non-profit organizations in accordance with Executive Order 12999, “Education technology: ensuring Opportunity for all children in the next century.” Appropriate instructions shall be issued to the Cooperator by the REE Agency. § 550.42 Intangible property.
(a)The Cooperator may copyright any work that is subject to copyright and was developed, by the Cooperator, or jointly by the Federal Government and the Cooperator, or for which ownership was purchased, under a cooperative agreement REE Agencies reserve a royalty-free, nonexclusive and irrevocable right to reproduce, publish, or otherwise use the work for Federal purposes, and to authorize others to do so for Federal purposes.
(b)Cooperators are subject to applicable regulations governing patents and inventions, including government-wide regulations issued by the Department of Commerce at 37 CFR Part 401, “Rights to Inventions Made by Nonprofit Organizations and Small Business Firms Under Government Grants, Contracts and Cooperative Agreements.”
(c)The REE Agency has the right to:
(1)Obtain, reproduce, publish or otherwise use the data first produced under a cooperative agreement; and
(2)Authorize others to receive, reproduce, publish, or otherwise use such data for Federal purposes. (d)(1) In addition, in response to a Freedom of Information Act
(FOIA)request for research data relating to published research findings produced under a cooperative agreement that were used by the Federal Government in developing an Agency action that has the force and effect of law, the REE Agency shall request, and the Cooperator shall provide, within a reasonable time, the research data so that they can be made available to the public through the procedures established under the FOIA. If the REE Agency obtains the research data solely in response to a FOIA request, the Agency may charge the requester a reasonable fee equaling the full incremental cost of obtaining the research data. This fee should reflect costs incurred by the Agency, the Cooperator, and applicable subrecipients. This fee is in addition to any fees the Agency may assess under the FOIA (5 U.S.C. 552(a)(4)(A)).
(2)The following definitions apply for purposes of paragraph
(d)of this section:
(i)Research data is defined as the recorded factual material commonly accepted in the scientific community as necessary to validate research findings, but not any of the following: preliminary analyses, drafts of scientific papers, plans for future research, peer reviews, or communications with colleagues. This “recorded” material excludes physical objects ( *e.g.* , laboratory samples). Research data also do not include:
(A)Trade secrets, commercial information, materials necessary to be held confidential by a researcher until they are published, or similar information which is protected under law; and
(B)Personnel and medical information and similar information the disclosure of which would constitute a clearly unwarranted invasion of personal privacy, such as information that could be used to identify a particular person in a research study.
(ii)Published is defined as either when:
(A)Research findings are published in a peer-reviewed scientific or technical journal;
(B)A Federal Agency publicly and officially cites the research findings in support of an Agency action that has the force and effect of law; or
(C)Used by the Federal Government in developing an Agency action that has the force and effect of law is defined as when an Agency publicly and officially cites the research findings in support of an Agency action that has the force and effect of law.
(e)All rights, title, and interest in any Subject Invention made solely by employee(s) of the REE Agency shall be owned by the REE Agency. All rights, title, and interest in any Subject Invention made solely by at least one
(1)Employee of the REE Agency and at least one
(1)employee of the Cooperator shall be jointly owned by the Agency and the Cooperator, subject to the provisions of 37 CFR part 401.
(f)REE Agencies shall have a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced for or on behalf of the United States the subject invention throughout the world. Procurement Standards § 550.43 Purpose of procurement standards. Sections 44 through 50 set forth standards for use by Cooperators in establishing procedures for the procurement of supplies and other expendable property, equipment and other services with Federal funds. These standards are furnished to ensure that such materials and services are obtained in an effective manner and in compliance with the provisions of applicable Federal statutes and executive orders. No additional procurement standards or requirements shall be imposed by the Federal awarding agencies upon Cooperators, unless specifically required by Federal statute or executive order or approved by OMB. § 550.44 Cooperator responsibilities. The standards contained in this section do not relieve the Cooperator of the contractual responsibilities arising under its' contract(s). The Cooperator is the responsible authority, without recourse to the REE Agency, regarding the settlement and satisfaction of all contractual and administrative issues arising out of procurements entered into in support of a nonassistance agreement. This includes disputes, claims, award protests, source evaluation or other matters of a contractual nature. Matters concerning violation of statute are to be referred to such Federal, State or local authority, as may have proper jurisdiction. § 550.45 Standards of conduct. The Cooperator shall maintain written standards of conduct governing the performance of its employees engaged in the award and administration of contracts. No employee, officer, or agent shall participate in the selection, award, or administration of a contract supported by Federal funds if a real or apparent conflict of interest would be involved. Such a conflict would arise when the employee, officer, or agent, any member of his or her immediate family, his or her partner, or an organization which employs or is about to employ any of the parties indicated herein, has a financial or other interest in the firm selected for an award. The officers, employees, and agents of the Cooperator shall neither solicit nor accept gratuities, favors, or anything of monetary value from contractors, or parties to subagreements. However, Cooperators may set standards for situations in which the financial interest is not substantial or the gift is an unsolicited item of nominal value. The standards of conduct shall provide for disciplinary actions to be applied for violations of such standards by officers, employees, or agents of the Cooperator. § 550.46 Competition.
(a)All procurement transactions shall be conducted in a manner to provide, to the maximum extent practical, open and free competition. The Cooperator shall be alert to organizational conflicts of interest as well as noncompetitive practices among contractors that may restrict or eliminate competition or otherwise restrain trade. In order to ensure objective contractor performance and eliminate unfair competitive advantage, contractors that develop or draft specifications, requirements, statements of work, invitations for bids and/or requests for proposals shall be excluded from competing for such procurements. Awards shall be made to the bidder or offeror whose bid or offer is responsive to the solicitation and is most advantageous to the Cooperator, price, quality and other factors considered. Solicitations shall clearly set forth all requirements that the bidder or offer shall fulfill in order for the bid or offer to be evaluated by the Cooperator. Any and all bids or offers may be rejected when it is in the Cooperator's interest to do so.
(b)Contracts shall be made only with responsible contractors who possess the potential ability to perform successfully under the terms and conditions of the proposed procurement. Consideration shall be given to such matters as contractor integrity, record of past performance, financial and technical resources or accessibility to other necessary resources. In certain circumstances, contracts with certain parties are restricted by agencies' implementation of Executive Orders 12549 and 12689, “Debarment and Suspension.”
(c)Recipients shall, on request, make available for the REE Agency, pre-award review and procurement documents, such as request for proposals or invitations for bids, independent cost estimates, etc. § 550.47 Cost and price analysis. Some form of cost or price analysis shall be made and documented in the procurement files in connection with every procurement action. Price analysis may be accomplished in various ways, including the comparison of price quotations submitted, market prices and similar indicia, together with discounts. Cost analysis is the review and evaluation of each element of cost to determine reasonableness, allocability and allowability. § 550.48 Procurement records. Procurement records and files for purchases in excess of the small purchase threshold shall include the following at a minimum:
(a)Basis for contractor selection,
(b)justification for lack of competition when competitive bids or offers are not obtained, and
(c)basis for award cost or price. § 550.49 Contract administration. A system for contract administration shall be maintained to ensure contractor conformance with the terms, conditions and specifications of the contract and to ensure adequate and timely follow up of all purchases. Recipients shall evaluate contractor performance and document, as appropriate, whether contractors have met the terms, conditions and specifications of the contract. § 550.50 Contract provisions. The recipient shall include, in addition to provisions to define a sound and complete agreement, the following provisions in all contracts. The following provisions shall also be applied to subcontracts.
(a)Contracts in excess of the simplified acquisition threshold shall contain contractual provisions or conditions that allow for administrative, contractual, or legal remedies in instances in which a contractor violates or breaches the contract terms, and provide for such remedial actions as may be appropriate.
(b)All contracts in excess of the simplified acquisition threshold shall contain suitable provisions for termination by the cooperator, including the manner by which termination shall be effected and the basis for settlement. In addition, such contracts shall describe conditions under which the contract may be terminated for default as well as conditions where the contract may be terminated because of circumstances beyond the control of the contractor.
(c)All negotiated contracts (except those for less than the simplified acquisition threshold) awarded by recipients shall include a provision to the effect that the recipient, the REE Agency, the Comptroller General of the United States, or any of their duly authorized representatives, shall have access to any books, documents, papers and records of the contractor which are directly pertinent to a specific program for the purpose of making audits, examinations, excerpts and transcriptions.
(d)All contracts, including small purchases, awarded by recipients and their contractors shall contain the procurement provisions of Appendix A, 2 CFR part 215, as applicable. Reports and Records § 550.51 Purpose of reports and records. Sections 550.52 through 550.55 of this part set forth the procedures for monitoring and reporting on the Cooperator's financial and program performance and the necessary reporting format. They also set forth record retention requirements, and property and equipment inventory reporting requirements. § 550.52 Reporting program performance.
(a)The REE Agency shall prescribe the frequency with which performance reports shall be submitted. Performance reports shall not be required more frequently than quarterly or, less frequently than annually. Annual reports shall be due 90 calendar days after the grant year; quarterly or semi-annual reports shall be due 30 days after the reporting period. The REE Agency may require annual reports before the anniversary dates of multiple year agreements in lieu of these requirements. The final performance reports are due 90 calendar days after the expiration or termination of the period of agreement.
(b)When required, performance reports shall contain, for each award, detailed information on each of the following.
(1)A comparison of actual accomplishments with the goals and objectives established for the period and the findings of the investigator. Whenever appropriate and the output of programs or projects can be readily quantified, such quantitative data should be related to cost data for computation of unit costs.
(2)Reasons why established goals were not met, if appropriate.
(3)Other pertinent information including, when appropriate, analysis and explanation of cost overruns or high unit costs.
(c)Cooperators shall not be required to submit more than the original and two copies of performance reports.
(d)Cooperators shall immediately notify the REE Agency of developments that have a significant impact on the award-supported activities. Also, notification shall be given in the case of problems, delays, or adverse conditions which materially impair the ability to meet the objectives of the award. This notification shall include a statement of the action taken or contemplated, and any assistance needed to resolve the situation. § 550.53 Financial reporting. Financial Status Report.
(a)Each REE Agency shall require Cooperators to report the status of funds as approved in the budget for the cooperative agreement. A financial status report shall consist of the following information:
(1)The name and address of the Cooperator.
(2)The name and address of the PI.
(3)The name, address, and signature of the financial officer submitting the report.
(4)A reference to the cooperative agreement.
(5)Period covered by the report.
(6)An itemization of actual dollar amounts expended on the project during the reporting period (in line with the approved budget) and cumulative totals expended for each budget category from the starting date of the cooperative agreement.
(b)The REE Agency shall determine the frequency of the Financial Status Report for each project or program, considering the size and complexity of the particular project or program. However, the report shall not be required more frequently than quarterly or less frequently than annually. A final report shall be required at the completion of the agreement.
(c)The REE Agency shall require Cooperators to submit the financial status report (an original and no more than two copies) no later than 30 days after the end of each specified reporting period for quarterly and semi-annual reports, and 90 calendar days for annual and final reports. Extensions of reporting due dates may be approved by the REE Agency upon request of the Cooperator. § 550.54 Invention disclosure and utilization reporting.
(a)The Cooperator shall report Invention Disclosures and Utilization information electronically via i-Edison Web Interface at: *www.iedison.gov.*
(b)If access to InterAgency Edison is unavailable, the invention disclosure should be sent directly to: DEITR, National Institutes of Health, 6701 Rockledge Drive, Room 3175, MSC 7750, Bethesda, Maryland 20892-7750. § 550.55 Retention and access requirements for records.
(a)This section sets forth requirements for record retention and access to records for awards to Cooperators. REE agencies shall not impose any other record retention or access requirements upon Cooperators, excepting as set out in 550.42(d).
(b)Financial records, supporting documents, statistical records, and all other records pertinent to an award shall be retained for a period of 3 years from the date of submission of the final expenditure report or, for awards that are renewed quarterly or annually, from the date of the submission of the quarterly or annual financial report, as authorized by the REE Agency. The only exceptions are the following:
(1)If any litigation, claim, or audit is started before the expiration of the 3- year period, the records shall be retained until all litigation, claims or audit findings involving the records have been resolved and final action taken;
(2)Records for real property and equipment acquired with Federal funds shall be retained for 3 years after final disposition;
(3)When records are transferred to or maintained by the REE Agency, the 3-year retention requirement is not applicable to the Cooperator;
(4)Indirect cost rate proposals, cost allocations plans, etc. as specified in paragraph
(f)of this section.
(c)Copies of original records may be substituted for the original records if authorized by the REE Agency.
(d)The REE Agency shall request transfer of certain records to its custody from Cooperators when it determines that the records possess long-term retention value. However, in order to avoid duplicate record keeping, a REE Agency may make arrangements for Cooperators to retain any records that are continuously needed for joint use.
(e)The REE Agency, the Inspector General, Comptroller General of the United States, or any of their duly authorized representatives, have the right of timely and unrestricted access to any books, documents, papers, or other records of Cooperators that are pertinent to the awards, in order to make audits, examinations, excerpts, transcripts and copies of such documents. This right also includes timely and reasonable access to a Cooperator's personnel for the purpose of interview and discussion related to such documents. The rights of access in this paragraph are not limited to the required retention period, but shall last as long as records are retained.
(f)No cooperator shall disclose its records that are pertinent to an award until the cooperator provides notice of the intended disclosure with copies of the relevant records to the REE Agency.
(g)*Indirect cost rate proposals, cost allocations plans, etc.* Paragraphs (g)(1) and (g)(2) of this section apply to the following types of documents, and their supporting records: indirect cost rate computations or proposals, cost allocation plans, and any similar accounting computations of the rate at which a particular group of costs is chargeable (such as computer usage charge back rates or composite fringe benefit rates).
(1)*If submitted for negotiation.* If the Cooperator submits to the REE Agency or the subrecipient submits to the Cooperator the proposal, plan, or other computation to form the basis for negotiation of the rate, then the 3-year retention period for its supporting records starts on the date of such submission.
(2)*If not submitted for negotiation.* If the Cooperator is not required to submit to the REE Agency or the subrecipient is not required to submit to the Cooperator the proposal, plan, or other computation for negotiation purposes, then the 3-year retention period for the proposal, plan, or other computation and its supporting records starts at the end of the fiscal year (or other accounting period) covered by the proposal, plan, or other computation. Suspension, Termination, and Enforcement § 550.56 Purpose of suspension, termination, and enforcement. Sections 550.57 and 550.58 of this part set forth uniform suspension, termination, and enforcement procedures. § 550.57 Suspension and termination. Awards may be suspended or terminated in whole or in part if 550.57(a), (b), or
(c)apply.
(a)The REE Agency may terminate the award, if a Cooperator materially fails to comply with the provisions of this rule or the terms and conditions of an award.
(b)The REE Agency with the consent of the Cooperator, in which case the two parties shall agree upon the termination conditions, including the effective date and, in the case of partial termination, the portion to be terminated.
(c)If costs are allowed under an award, the responsibilities of the Cooperator referred to in § 550.32, including those for property management as applicable, shall be considered in the termination of the award, and provision shall be made for continuing responsibilities of the Cooperator after termination, as appropriate. § 550.58 Enforcement.
(a)Remedies for noncompliance. If a Cooperator materially fails to comply with the terms and conditions of an award, whether stated in a Federal statute, regulation, assurance, application, or notice of award, the REE Agency may, in addition to imposing any of the special conditions outlined in § 550.10, take one or more of the following actions.
(1)Temporarily withhold cash payments pending correction of the deficiency by the Cooperator or more severe enforcement action by the REE Agency.
(2)Disallow all or part of the cost of the activity or action not in compliance.
(3)Wholly or partly suspend or terminate the current award.
(4)Withhold further awards for the project or program.
(5)Take other remedies that may be legally available.
(b)Effects of suspension and termination. Costs of a Cooperator resulting from obligations incurred by the Cooperator during a suspension or after termination of an award are not allowable unless the REE Agency expressly authorizes them in the notice of suspension or termination or thereafter. Other Cooperator costs during suspension or after termination which are necessary and not reasonably avoidable are allowable if § 550.58
(1)and
(2)apply.
(1)The costs result from obligations which were properly incurred by the Cooperator before the effective date of suspension or termination, are not in anticipation of it, and in the case of a termination, are non-cancellable.
(2)The costs would be allowable if the award were not suspended or expired normally at the end of the funding period in which the termination takes effect.
(3)Relationship to debarment and suspension. The enforcement remedies identified in this section, including suspension and termination, do not preclude a Cooperator from being subject to debarment and suspension under Executive Orders 12549 and 12689 and USDA implementing regulations (7 CFR Part 3017). Subpart D—Close Out § 550.59 Purpose. Sections 550.60 through 550.62 of this part contain closeout procedures and other procedures for subsequent disallowances and adjustments. § 550.60 Closeout procedures.
(a)Cooperators shall submit, within 90 calendar days after the date of completion of the award, all financial, performance, and other reports as required by the terms and conditions of the award. The REE Agency may approve extensions to the reporting period when requested by the Cooperator.
(b)Unless the REE Agency authorizes an extension, a Cooperator shall liquidate all obligations incurred under the award not later than 90 calendar days after the funding period or the date of completion as specified in the terms and conditions of the award or in Agency implementing instructions.
(c)The REE Agency shall make prompt payments to a Cooperator for allowable reimbursable costs under the award being closed out.
(d)The Cooperator shall promptly refund any balance of unobligated cash advanced or paid by the REE Agency that it is not authorized to retain for use in other projects. OMB Circular A-129 governs unreturned amounts that become delinquent debts.
(e)When authorized by the terms and conditions of the award, the REE Agency shall make a settlement for any upward or downward adjustments to the Federal share of costs after closeout reports are received.
(f)The Cooperator shall account for any personal property acquired with Federal funds or received from the Federal Government in accordance with § 550.36 through § 550.42.
(g)In the event a final audit has not been performed prior to the closeout of an award, the REE Agency shall retain the right to recover an appropriate amount after fully considering the recommendations on disallowed costs resulting from the final audit. § 550.61 Subsequent adjustments and continuing responsibilities. The closeout of an award does not affect any of the following.
(a)The right of the REE Agency to disallow costs and recover funds on the basis of a later audit or other review.
(b)The obligation of the Cooperator to return any funds due as a result of later refunds, corrections, or other transactions.
(c)Audit requirements in § 550.24.
(d)Property management requirements in § 550.36 through § 550.42.
(e)Records retention as required in § 550.56. § 550.62 Collection of amounts due.
(a)Any funds paid to a Cooperator in excess of the amount to which the Cooperator is finally determined to be entitled under the terms and conditions of the award constitute a debt to the Federal Government. If not paid within a reasonable period after the demand for payment, the REE Agency may in accordance with 7 CFR Part 3, reduce the debt by—
(1)Making an administrative offset against other requests for reimbursements or
(2)Withholding advance payments otherwise due to the Cooperator, or
(3)Taking other action permitted by statute.
(b)Except as otherwise provided by law, the REE Agency shall charge interest on an overdue debt in accordance with 31 CFR Part 900, “Federal Claims Collection Standards.” Dated: July 5, 2007. Edward B. Knipling, Administrator, Agricultural Research Service. [FR Doc. E7-13550 Filed 7-25-07; 8:45 am] BILLING CODE 3410-03-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2007-28432; Directorate Identifier 2007-CE-051-AD] RIN 2120-AA64 Airworthiness Directives; Thrush Aircraft, Inc. Models S2R Series Airplanes AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: We propose to adopt a new airworthiness directive
(AD)for certain Thrush Aircraft, Inc. (Thrush) Model S2R series airplanes. This proposed AD would require repetitive visual inspections of the vertical and horizontal stabilizer attach fitting, attach fitting bolts, and the vertical fin aft spar for cracks or corrosion and require immediate replacement of cracked or corroded parts and eventual replacement if no cracks or corrosion is found as terminating action for the repetitive inspections. This proposed AD results from reports of cracks in the empennage of Thrush S2R series airplanes. We are proposing this AD to detect and correct these cracks, which could cause the vertical stabilizer to lose structural integrity. This condition could lead to loss of control. DATES: We must receive comments on this proposed AD by September 24, 2007. ADDRESSES: Use one of the following addresses to comment on this proposed AD: • *DOT Docket Web site:* Go to *http://dms.dot.gov* and follow the instructions for sending your comments electronically. • *Mail:* U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. • *Fax:*
(202)493-2251. • *Hand Delivery:* U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. • *Federal eRulemaking Portal:* Go to *http://www.regulations.gov.* Follow the instructions for submitting comments. For service information identified in this proposed AD, contact: Thrush Aircraft, Inc., P.O. Box 3149, 300 Old Pretoria Road, Albany, Georgia 31706-3149; telephone: 229-883-1440; facsimile: 229-436-4856; or on the Internet at: *http://www.thrushaircraft.com.* FOR FURTHER INFORMATION, CONTACT ONE OF THE FOLLOWING: —Cindy Lorenzen, Aerospace Engineer, ACE-115A, Atlanta Aircraft Certification Office, One Crown Center, 1895 Phoenix Blvd., Suite 450, Atlanta, Georgia 30349; telephone:
(770)703-6078; facsimile:
(770)703-6097; e-mail: *cindy.lorenzen@faa.gov;* or —Mike Cann, Aerospace Engineer, ACE-117A, Atlanta Aircraft Certification Office, One Crown Center, 1895 Phoenix Blvd., Suite 450, Atlanta, Georgia 30349; telephone:
(770)703-6038; facsimile:
(770)703-6097; e-mail: *michael.cann@faa.gov.* SUPPLEMENTARY INFORMATION: Comments Invited We invite you to send any written relevant data, views, or arguments regarding this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include the docket number, “FAA-2007-28432; Directorate Identifier 2007-CE-051-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the proposed AD. We will consider all comments received by the closing date and may amend the proposed AD in light of those comments. We will post all comments we receive, without change, to *http://dms.dot.gov,* including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive concerning this proposed AD. Discussion We have received reports of cracks in the empennage of Thrush S2R series airplanes. Cracks may occur in the vertical stabilizer attach fitting, the horizontal stabilizer attach fitting, attach fitting bolts, and/or the vertical fin aft spar on airplanes with metal empennages. A metallurgy report suggests stress corrosion cracking is the cause of these cracks. A report was received from the field that a 5/16 -inch vertical attach bolt, part number (P/N) NAS1105-68, was found broken in two places, causing the rear spar of the vertical fin to crack. A separate incident found the attach fitting on the stabilizer itself cracked in both lugs from stress corrosion. This condition, if not corrected, could cause the vertical stabilizer to lose structural integrity. This condition could lead to loss of control. Relevant Service Information We have reviewed Thrush Aircraft, Inc., Service Bulletin No. SB-AG-45, Revision B, dated June 1, 2007. The service information describes procedures for inspecting and upgrading the fin spar and attach fittings. FAA's Determination and Requirements of the Proposed AD We are proposing this AD because we evaluated all information and determined the unsafe condition described previously is likely to exist or develop on other products of the same type design. This proposed AD would require repetitive visual inspections of the vertical and horizontal stabilizer attach fitting, attach fitting bolts, and the vertical fin aft spar for cracks or corrosion and require immediate replacement of cracked or corroded parts and eventual replacement if no cracks or corrosion is found as terminating action for the repetitive inspections. Differences Between This Proposed AD and the Service Information Thrush Aircraft, Inc. SB-AG-45, Revision B, dated June 1, 2007, recommends an immediate initial inspection. We consider immediately upon receipt action to be an urgent safety of flight compliance time. Because our risk assessment does not indicate this unsafe condition to be an urgent safety of flight condition, we propose to require an initial inspection within the next 50 hours time-in-service (TIS). The initial inspection time of 50 hours TIS is an adequate compliance for this AD action and meets the FAA requirements of an NPRM. We propose to require a terminating action of replacing the parts within the next 2 years or 2,000 hours TIS, whichever occurs first. This is recommended because there is historic evidence that inspections alone can eventually miss detecting a crack. Costs of Compliance We estimate that this proposed AD would affect 910 airplanes in the U.S. registry. We estimate the following costs to do the proposed inspection: Labor cost Parts cost Total cost per airplane Total cost on U.S. operators 8 work-hours × $80 per hour = $640 Not applicable $640 $582,400 We estimate the following costs to do any necessary replacements of the vertical fin aft spar that would be required based on the results of the proposed inspection. We have no way of determining the number of airplanes that may need this replacement: Labor cost Parts cost Total cost per airplane 12 work-hours × $80 per hour = $960 $3,800 $4,760 We estimate the following costs to replace the vertical and horizontal stabilizer attach fittings and attachment bolt: Labor cost Parts cost Total cost per airplane Total cost on U.S. operators 30 work-hours × $80 per hour = $2,400 $1,550 $3,950 $3,594,500 Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority. We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings We have determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify that the proposed regulation: 1. Is not a “significant regulatory action” under Executive Order 12866; 2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and 3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket. Examining the AD Docket You may examine the AD docket that contains the proposed AD, the regulatory evaluation, any comments received, and other information on the Internet at *http://dms.dot.gov;* or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Office (telephone
(800)647-5527) is located at the street address stated in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Safety. The Proposed Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The FAA amends § 39.13 by adding the following new AD: **Thrush Aircraft, Inc.:** Docket No. FAA-2007-28432; Directorate Identifier 2007-CE-051-AD. Comments Due Date
(a)We must receive comments on this airworthiness directive
(AD)action by September 24, 2007. Affected ADs
(b)None. Applicability
(c)This AD applies to the following airplane models and serial numbers that are certificated in any category and are equipped with metal empennage part numbers (P/N) 40220 or 95400 (applies to serial numbers with or without a “DC” suffix): Model Serial Nos.
(1)S2R 1416R through 5100R.
(2)S2R-R1340 R1340-001 through R1340-035.
(3)S2R-R1820 R1820-001 through R1820-036.
(4)S2R-T11 T11-001 through T11-005.
(5)S2R-T15 T15-001 through T15-044 and T27-001 through T27-044.
(6)S2R-T34 6000 through 6049, T34-001 through T34-279, T36-001 through T36-279, T41-001 through T41-279, T42-001 through T42-279.
(7)S2RHG-T34 T34HG-101 through T34HG-107.
(8)S2R-T45 T45-001 through T45-015.
(9)S2R-T65 T65-001 through T65-018.
(10)S2RHG-T65 T65-001 through T65-018 and T65HG-011 through T65HG-019.
(11)S2R-G1 G1-101 through G1-115.
(12)S2R-G5 G5-101 through G5-105.
(13)S2R-G6 G6-101 through G6-155.
(14)S2R-G10 G10-101 through G10-168.
(15)S2R-T660 T660-101 through T660-120. Unsafe Condition
(d)This proposed AD results from reports of cracks in the empennage of Thrush Aircraft, Inc., S2R series airplanes. We are proposing this AD to detect and correct these cracks, which could cause the vertical stabilizer to lose structural integrity. This condition could lead to loss of control. Compliance
(e)To address this problem, you must do the following, unless already done: Actions Compliance Procedures
(1)Perform a visual inspection of the vertical stabilizer attach fitting (P/N 40301-7), the horizontal stabilizer attach fitting (P/N 40303-1/-4/-7 or 95267-1), attachment bolt (P/N NAS1105-68), and vertical fin aft spar (P/N 40261-24 or P/N 95253-1), for cracks or corrosion Within the next 50 hours time-in-service
(TIS)after the effective date of this AD and repetitively thereafter at intervals not to exceed every 100 hours TIS for up to 2 years or a total of 2,000 hours TIS, whichever occurs first Follow Thrush Aircraft, Inc. Service Bulletin No. SB-AG-45, Revision B, dated June 1, 2007.
(2)If cracks or corrosion are found in P/N 40301-7, 40303-1/-4/-7, 95267-1, or NAS1105-68 during any inspection required in paragraph (e)(1) of this AD, replace all three parts with new P/Ns 95266-3, 95267-5 and NAS6207-68 Before further flight after any inspection where cracks or corrosion are found Follow Thrush Aircraft, Inc. Service Bulletin No. SB-AG-45, Revision B, dated June 1, 2007.
(3)If cracks or corrosion are found in P/N 40261-24 or 95253-1 during any inspection required in paragraph (e)(1) of this AD, replace with a new P/N 40261-24 or 95253-1, or repair in accordance with Thrush SB-AG-45, Revision B Before further flight after any inspection where cracks or corrosion are found Follow Thrush Aircraft, Inc. Service Bulletin No. SB-AG-45, Revision B, dated June 1, 2007.
(4)Replace vertical stabilizer attach fitting P/N 40301-7 with P/N 95266-3, replace horizontal stabilizer attach fitting P/N 40303-1/-4/-7 or 95267-1 with P/N 95267-5, and replace attachment bolt NAS1105-68 with NAS6207-68 bolt Within the next 2,000 hours TIS after the effective date of this AD or within 2 years after the effective date of this AD, whichever occurs first. This action terminates the repetitive inspections required in paragraph (e)(1) of this AD, including the inspections of the vertical fin aft spar, P/N 40261-24 or 95253-1 Follow Thrush Aircraft, Inc. Service Bulletin No. SB-AG-45, Revision B, dated June 1, 2007. Special Flight Permit
(f)Under 14 CFR part 39.23, we are limiting the special flight permits authorized for this AD to ferry aircraft to a maintenance facility for inspection by the following conditions:
(1)Hopper must be empty.
(2)Vne reduced to 126 m.p.h. (109 knots); and
(3)No flight into known turbulence. Alternative Methods of Compliance (AMOCs)
(g)The Manager, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Cindy Lorenzen, Aerospace Engineer, ACE-115A, Atlanta Aircraft Certification Office, One Crown Center, 1895 Phoenix Blvd., Suite 450, Atlanta, GA 30349; telephone:
(770)703-6078; facsimile:
(770)703-6097; e-mail: *cindy.lorenzen@faa.gov;* or Mike Cann, Aerospace Engineer, ACE-117A, Atlanta Aircraft Certification Office, One Crown Center, 1895 Phoenix Blvd., Suite 450, Atlanta, Georgia 30349; telephone:
(770)703-6038; facsimile:
(770)703-6097; e-mail: *michael.cann@faa.gov.* Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector
(PI)in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO. Related Information
(h)To get copies of the service information referenced in this AD, contact Thrush Aircraft, Inc., P.O. Box 3149, 300 Old Pretoria Road, Albany, Georgia 31706-3149; telephone: 229-883-1440; facsimile: 229-436-4856; or on the Internet at: *http://www.thrushaircraft.com.* To view the AD docket, go to U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, or on the Internet at *http://dms.dot.gov.* The docket number is Docket No. FAA-2007-28432; Directorate Identifier 2007-CE-051-AD. Issued in Kansas City, Missouri, on July 20, 2007. Kim Smith, Manager, Small Airplane Directorate, Aircraft Certification Service. [FR Doc. E7-14433 Filed 7-25-07; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 301 [REG-149036-04] RIN 1545-BE07 Application of Section 6404(g) of the Internal Revenue Code Suspension Provisions; Correction AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Correction to notice of proposed rulemaking by cross-reference to temporary regulations. SUMMARY: This document contains corrections to notice of proposed rulemaking by cross-reference to temporary regulations (REG-149036-04) that were published in the **Federal Register** on Thursday, June 21, 2007 (72 FR 34204) relating to the application of section 6404(g) of the Internal Revenue Code suspension provisions. FOR FURTHER INFORMATION CONTACT: Stuart Spielman,
(202)622-7950 (not a toll-free number). SUPPLEMENTARY INFORMATION: Background The notice of proposed rulemaking by cross-reference to temporary regulations that are the subject of this correction are under section 6404(g) of the Internal Revenue Code. Need for Correction As published, proposed regulations (REG-149036-04) contains an error that may prove to be misleading and is in need of clarification. Correction of Publication Accordingly, the publication of the proposed regulations (REG-149036-04), which was the subject of FR Doc. E7-12085, is corrected as follows: On page 34204, column 1, in the preamble, under the caption SUMMARY: , lines 11 through 13, the language “the gulf Opportunity zone act of 2005, and the Tax Relief and Health Care Act of 2006. The regulations provide” is corrected to read “the Gulf Opportunity Zone Act of 2005, the Tax Relief and Health Care Act of 2006, and the Small Business and Work Opportunity Tax Act of 2007. The regulations provide”. LaNita Van Dyke, Chief, Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel (Procedure and Administration). [FR Doc. E7-14400 Filed 7-25-07; 8:45 am] BILLING CODE 4830-01-P DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 301 [REG-149036-04] RIN 1545-BG75 Application of Section 6404(g) of the Internal Revenue Code Suspension Provisions; Correction AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Correction to notice of proposed rulemaking. SUMMARY: This document contains corrections to the notice of proposed rulemaking (REG-149036-04) that were published in the **Federal Register** on Thursday, June 21, 2007 (72 FR 34199) proposing regulations for the suspension of interest, penalties, additions to tax or additional amounts under section 6404(g) of the Internal Revenue Code that explain the general rules for suspension as well as exceptions to those general rules. FOR FURTHER INFORMATION CONTACT: Stuart Spielman,
(202)622-7950 (not a toll-free number). SUPPLEMENTARY INFORMATION: Background The notice of proposed rulemaking that is the subject of this correction is under section 6404(g) of the Internal Revenue Code. Need for Correction As published, the proposed regulations (REG-149036-04) contain errors that may prove to be misleading and are in need of clarification. Correction of Publication Accordingly, the publication of the proposed regulations (REG-149036-04), which was the subject of FR Doc. E7-12082, is corrected as follows: 1. On page 34200, column 1, in the preamble, under the caption SUMMARY: , lines 4 and 5, the language “and the Tax Relief and Health Care Act of 2006. The proposed regulations affect” is corrected to read “the Tax Relief and Health Care Act of 2006, and the Small Business and Work Opportunity Tax Act of 2007. The proposed regulations affect”. 2. On page 34200, column 2, in the preamble, under the paragraph heading “Background”, line 8, the language “Law 110-28 (121 Stat. 112, 200),” is corrected to read “Law 110-28 (121 Stat. 190, 200),”. LaNita Van Dyke, Chief, Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel (Procedure and Administration). [FR Doc. E7-14397 Filed 7-25-07; 8:45 am] BILLING CODE 4830-01-P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 622 RIN 0648-AT87 Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Shrimp Fishery of the Gulf of Mexico and Reef Fish Fishery of the Gulf of Mexico; Amendment 14/27 AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Announcement of availability of fishery management plan amendment; request for comments. SUMMARY: NMFS announces the Gulf of Mexico Fishery Management Council (Council) has submitted a joint Amendment 14 to the Fishery Management Plan
(FMP)for the Shrimp Fishery of the Gulf of Mexico and Amendment 27 to the FMP for the Reef Fish Resources of the Gulf of Mexico for review, approval, and implementation by NMFS. Amendment 14/27 proposes actions to reduce the red snapper catch, bycatch, and discard mortality in the directed commercial and recreational fisheries and the shrimp fishery. The intended effect of joint Amendment 14/27 is to end overfishing for red snapper between 2009 and 2010 and rebuild the stock by 2032 in compliance with the red snapper rebuilding plan. DATES: Written comments must be received no later than 5 p.m., eastern time, on September 24, 2007. ADDRESSES: You may submit comments by any of the following methods: • E-mail: *0648-AT87.NOA27-14@noaa.gov* . Include in the subject line the following document identifier: 0648-AT87-NOA27-14. • Federal e-Rulemaking Portal: *http://www.regulations.gov* . Follow the instructions for submitting comments. • Mail: Peter Hood, Southeast Regional Office, NMFS, 263 13 th Avenue South, St. Petersburg, FL 33701. • Fax: 727-824-5308, Attention: Peter Hood. Copies of joint Amendment 14/27, which includes an Environmental Impact Statement, a Regulatory Impact Review, and an Initial Regulatory Flexibility Analysis, are available in electronic format from the Council's web site at *http://www.gulfcouncil.org* , or by contacting the Council at 2203 North Lois Avenue, Suite 1100, Tampa, FL, 33607; phone: 813-348-1630; fax: 813-348-1711; e-mail: *gulfcouncil@gulfcouncil.org* . FOR FURTHER INFORMATION CONTACT: Mr. Peter Hood, 727-824-5305; fax 727-824-5308; e-mail: *peter.hood@noaa.gov* . SUPPLEMENTARY INFORMATION: The Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) requires each Regional Fishery Management Council to submit any fishery management plan or amendment to NMFS for review and approval, disapproval, or partial approval. The Magnuson-Stevens Act also requires that NMFS, upon receiving a plan or amendment, publish an announcement in the **Federal Register** notifying the public that the plan or amendment is available for review and comment. Elements of Amendment 14/27 constitute a revised rebuilding plan that has at least a 50-percent probability of rebuilding the red snapper stock by 2032. Proposed actions focus around a reduction in red snapper total allowable catch to 5 million lb (2.3 million kg). This would result in a commercial quota of 2.55 million lb (1.16 million kg) and a recreational quota of 2.45 million lb (1.11 million kg). Recreational bag limits would be reduced from four fish to two fish; the bag limit for captain and crew of for-hire vessels would be set at zero. The commercial minimum size limit would be reduced to 13 inches (33 cm) total length with the intent of reducing regulatory discards. To reduce discard mortality in the directed fisheries, Amendment 14/27 proposes an action to require the use of venting tools, dehooking devices, and non-stainless steel circle hooks (when using natural baits) for all reef fish fishery sectors. In addition, the amendment would establish a target reduction goal for shrimp trawl bycatch mortality on red snapper, establish options for time-area closures for the shrimp fishery that would maintain the target reduction goal, and establish a framework whereby NMFS could implement such closures in a timely fashion. Length of the recreational fishing season will be determined by a number of factors. The proposed two-fish bag limit alone would allow a June 1 through September 15 (107 days) recreational fishing season. In addition to the two-fish bag limit, constraining the captain and crew of for-hire vessels to a zero-fish bag limit would allow the fishing season to be extended through the end of September (122 days). Based on extensive public comment, the Council chose to assume a 10-percent reduction in post-hurricane fishing effort and landings when evaluating recreational management measures. Application of this assumption, along with implementation of the two-fish bag limit and the zero-fish captain and crew limit of for-hire vessels, would allow the recreational fishing season to extend from May 15 through October 15 (154 days). This assumption is controversial because although preliminary data suggest some declines have occurred since the 2005 hurricane season, the magnitude of reductions varies- by fishing sector, is often less than 10 percent, and in some cases effort or landings have increased. Further, it is unknown how long post-hurricane reductions in landings and fishing effort may continue as the fisheries recover. Therefore, NMFS is specifically requesting comments on the assumed 10-percent reduction in effort and landings as proposed in Amendment 27/14, which would affect the designation of the length of the recreational fishing season established by this rule. A proposed rule that would implement measures outlined in joint Amendment 14/27 has been received from the Council. In accordance with the Magnuson-Stevens Act, NMFS is evaluating the proposed rule to determine whether it is consistent with the FMP, the Magnuson-Stevens Act, and other applicable law. If that determination is affirmative, NMFS will publish the proposed rule in the **Federal Register** for public review and comment. Comments received by September 24, 2007, whether specifically directed to the amendment or the proposed rule, will be considered by NMFS in its decision to approve, disapprove, or partially approve the amendment. Comments received after that date will not be considered by NMFS in this decision. All comments received by NMFS on the amendment or the proposed rule during their respective comment periods will be addressed in the final rule. Authority: 16 U.S.C. 1801 *et seq.* Dated: July 23, 2007. James P. Burgess, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service. [FR Doc. E7-14450 Filed 7-25-07; 8:45 am] BILLING CODE 3510-22-S DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 648 RIN 0648-AV70 Magnuson-Stevens Fishery Conservation and Management Act Provisions; Fisheries of the Northeastern United States; Northeast Region Standardized Bycatch Reporting Methodology Omnibus Amendment AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Notice of availability of proposed fishery management plan amendment; request for comments. SUMMARY: NMFS announces that the Mid-Atlantic and New England Fishery Management Councils (Councils) have submitted an Omnibus Amendment to the Fishery Management Plans
(FMPs)of the Northeast Region to establish a Standardized Bycatch Reporting Methodology (SBRM), incorporating a draft Environmental Assessment
(EA)and preliminary Regulatory Impact Review (RIR), for review by the Secretary of Commerce, and is requesting comments from the public. The SBRM Amendment would establish an SBRM for all 13 Northeast Region FMPs, as required under the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act). The proposed measures include: Bycatch reporting and monitoring mechanisms; analytical techniques and allocation of at-sea fisheries observers; an SBRM performance standard; a review and reporting process; framework adjustment and annual specifications provisions; a prioritization process; and provisions for industry-funded observers and observer set-aside programs. DATES: Comments must be received on or before September 24, 2007. ADDRESSES: You may submit comments by any of the following methods: • E-mail: *SBRM.Amend.NOA@noaa.gov* . Include in the subject line the following identifier: “Comments on the SBRM Omnibus Amendment.” • Federal e-rulemaking portal: *http://www.regulations.gov.* • Mail: Patricia A. Kurkul, Regional Administrator, NMFS, Northeast Regional Office, One Blackburn Drive, Gloucester, MA 01930. Mark the outside of the envelope: “Comments on the SBRM Omnibus Amendment.” • Fax:
(978)281-9135 Copies of the SBRM Amendment, and of the draft Environmental Assessment and preliminary Regulatory Impact Review (EA/RIR), are available from Daniel T. Furlong, Executive Director, Mid-Atlantic Fishery Management Council, Room 2115, Federal Building, 300 South New Street, Dover, DE 19901-6790; and from Paul J. Howard, Executive Director, New England Fishery Management Council, 50 Water Street, Newburyport, MA 01950. The EA/RIR is also accessible via the Internet at *http://www.nero.noaa.gov* . FOR FURTHER INFORMATION CONTACT: Michael Pentony, Senior Fishery Policy Analyst, 978-281-9283. SUPPLEMENTARY INFORMATION: The Magnuson-Stevens Act requires that each Regional Fishery Management Council submit any FMP amendment it prepares to NMFS for review and approval, disapproval, or partial approval. The Magnuson-Stevens Act also requires that NMFS, upon receiving an FMP amendment, immediately publish notification in the **Federal Register** that the amendment is available for public review and comment. If approved by NMFS, this amendment would establish a comprehensive SBRM that applies to all Northeast Region FMPs developed by either the Mid-Atlantic or New England Councils. The amendment would also effect an administrative change to the regulations on framework adjustments. Background Section 303(a)(11) of the Magnuson-Stevens Act requires that all FMPs “establish a standardized reporting methodology to assess the amount and type of bycatch occurring in the fishery.” In 2004, several conservation organizations challenged the approval of two major amendments to Northeast Region FMPs. In ruling on these suits, the U.S. District Court for the District of Columbia found that the FMPs did not clearly establish an SBRM as required under this section and remanded the amendments back to the agency to fully develop and establish the required SBRM. In particular, the Court found that the amendments
(1)failed to fully evaluate reporting methodologies to assess bycatch,
(2)did not mandate an SBRM, and
(3)failed to respond to potentially important scientific evidence. In response, the Councils, working closely with NMFS, undertook development of a remedy that would address all Northeast Region FMPs. In January 2006, development began on the Northeast Region Omnibus SBRM Amendment. This amendment covers 13 FMPs, 39 managed species, and 14 types of fishing gear. The purpose of the amendment is to: Explain the methods and processes by which bycatch is currently monitored and assessed for Northeast Region fisheries; determine whether these methods and processes need to be modified and/or supplemented; establish standards of precision for bycatch estimation for all Northeast Region fisheries; and, thereby, document the SBRM established for all fisheries managed through the FMPs of the Northeast Region. The amendment also responds to the “potentially important scientific evidence” cited by the Court in the two decisions referenced above. The Northeast Region SBRM Amendment would establish an SBRM comprised of seven elements:
(1)The methods by which data and information on discards are collected and obtained;
(2)the methods by which the data obtained through the mechanisms identified in element 1 are analyzed and utilized to determine the appropriate allocation of at-sea observers;
(3)a performance measure by which the effectiveness of the Northeast Region SBRM can be measured, tracked, and utilized to effectively allocate the appropriate number of observer sea days;
(4)a process to provide the Councils with periodic reports on discards occurring in Northeast Region fisheries and on the effectiveness of the SBRM;
(5)a measure to enable the Councils to make changes to the SBRM through framework adjustments and/or annual specification packages rather than full FMP amendments;
(6)a process to provide the Councils, and the public, with an opportunity to consider, and provide input into, the decisions regarding prioritization of at-sea observer coverage allocations; and
(7)to implement consistent, cross-cutting observer service provider approval and certification procedures and to enable the Councils to implement either a requirement for industry-funded observers or an observer set-aside program through a framework adjustment rather than an FMP amendment. Public comments are being solicited on the SBRM Amendment and its incorporated documents through the end of the comment period stated in this notice of availability. A proposed rule that would implement the SBRM Amendment will be published in the **Federal Register** for public comment, following NMFS's evaluation of the proposed rule under the procedures of the Magnuson-Stevens Act. Public comments on the proposed rule must be received by the end of the comment period provided in this notice of availability of the SBRM Amendment to be considered in the approval/disapproval decision on the amendment. All comments received by September 24, 2007, whether specifically directed to the SBRM Amendment or the proposed rule will be considered in the approval/disapproval decision on the amendment. Comments received after that date will not be considered in the decision to approve or disapprove the SBRM Amendment. To be considered, comments must be received by close of business on the last day of the comment period; that does not mean postmarked or otherwise transmitted by that date. Authority: 16 U.S.C. 1801 *et seq.* Dated: July 20, 2007. Emily Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service. [FR Doc. E7-14455 Filed 7-25-07; 8:45 am] BILLING CODE 3510-22-S 72 143 Thursday, July 26, 2007 Notices DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request July 23, 2007. The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments regarding
(a)whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(b)the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used;
(c)ways to enhance the quality, utility and clarity of the information to be collected;
(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 should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), *OIRA_Submission@OMB.EOP.GOV* or fax
(202)395-5806 and to Departmental Clearance Office, USDA, OCIO, Mail Stop 7602, Washington, DC 20250-7602. Comments regarding these information collections are best assured of having their full effect if received within 30 days of this notification. Copies of the submission(s) may be obtained by calling
(202)720-8681. An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number. Agricultural Marketing Service *Title:* Cotton Classing, Testing, and Standards. *OMB Control Number:* 0581-0008. *Summary of Collection:* The U.S. Cotton Standards Act, 7 U.S.C. 51 53 and 55, authorizes the USDA to supervise the various activities directly associated with the classification or grading of cotton, cotton linters, and cottonseed based on official USDA Standards. The Cotton Program of the Agricultural Marketing Service carries out this supervision and is responsible for the maintenance of the functions to which these forms relate. USDA is the only Federal agency authorized to establish and promote the use of the official cotton standards of the U.S. in interstate and foreign commerce and to supervise the various activities associated with the classification or grading of cotton, cotton linters, and cottonseed based on official USDA standards. *Need and Use of the Information:* The Agricultural Marketing Service uses the following forms to collection information: Form FD-210 is submitted by owners of cotton to request cotton classification services. The request contains information for USDA to ascertain proper ownership of the samples submitted, to distribute classification results, and bill for services. Information about the origin and handling of the cotton is necessary in order to properly evaluate and classify the samples. Form CN-246 is submitted by cotton gins and warehouses seeking to serve as licensed samplers. Licenses issued by the USDA-AMS Cotton Program authorize the warehouse/gin to draw and submit samples to insure the proper application of standards in the classification of cotton and to prevent deception in their use. Form CN-383 is a package of forms designated as CN-383-a through CN-383-k that is submitted by cotton producers, ginners, warehousemen, cooperatives, manufacturers, merchants, and crushers interested in acquiring cotton classification standards and round testing services. *Description of Respondents:* Business or other for-profit. *Number of Respondents:* 967. *Frequency of Responses:* Reporting: Annually; on occasion. *Total Burden Hours:* 140. Agricultural Marketing Service *Title:* Cotton Classification and Market News Service. *OMB Control Number:* 0581-0009. *Summary of Collection:* The Cotton Statistics and Estimates Act, 7 U.S. Code 471-476, authorizes the Secretary of Agriculture to collect and publish annually statistics or estimates concerning the grades and staple lengths of stocks of cotton. In addition, Agricultural Marketing Service
(AMS)collects, authenticates, publishes, and distributes timely information of the market supply, demand, location, and market prices for cotton (7 U.S.C. 473B). This information is needed and used by all segments of the cotton industry. *Need and Use of the Information:* AMS will collect information on the quality of cotton in the carryover stocks along with the size or volume of the carryover. Growers use this information in making decisions relative to marketing their present crop and planning for the next one; cotton merchants use the information in marketing decisions; and the mills that provide the data also use the combined data in planning their future purchase to cover their needs. Importers of U.S. cotton use the data in making their plans for purchases of U.S. cotton. AMS and other government agencies are users of the compiled information. *Description of Respondents:* Business or other for-profit. *Number of Respondents:* 1,066. *Frequency of Responses:* Reporting: On occasion; Weekly; Annually. *Total Burden Hours:* 1,161. Charlene Parker, Departmental Information Collection Clearance Officer. [FR Doc. E7-14471 Filed 7-25-07; 8:45 am] BILLING CODE 3410-02-P DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request July 23, 2007. The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments regarding
(a)whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(b)the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used;
(c)ways to enhance the quality, utility and clarity of the information to be collected;
(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 should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), *OIRA_Submission@OMB.EOP.GOV* or fax
(202)395-5806 and to Departmental Clearance Office, USDA, OCIO, Mail Stop 7602, Washington, DC 20250-7602. Comments regarding these information collections are best assured of having their full effect if received within 30 days of this notification. Copies of the submission(s) may be obtained by calling
(202)720-8958. An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number. Food and Nutrition Service *Title:* Operating Guidelines, Forms and Waivers. *OMB Control Number:* 0584-0083. *Summary of Collection:* Section 11(d) of the Food Stamp Act of 1977, as amended, provides that the State agency of each participating State shall submit to the Secretary for approval a plan of operation specifying the manner in which the Food Stamp Program will be conducted within the State in every political subdivision. Section 11(e) of the Act provides that the State plan of operation shall provide for State agency verification of household eligibility prior to certification, completion of certification within 30 days of filing of the application, fair hearing, and submission of reports as required by the Secretary. The basic components of the State Plan of Operation are the Federal/State Agreement, the Budget Projection Statement, and the Program Activity Statement (272.2(a)(2)). Under part 272.2(c), the State agency shall submit to the Food and Nutrition Service
(FNS)for approval a Budget Projection Statement (which projects total Federal administrative costs for the upcoming fiscal year) and a Program Activity Statement (which provides program activity data for the preceding fiscal year). FNS will collect information using forms FNS 366A and FNS 366B. *Need and Use of the Information:* FNS will collect information to estimate funding needs and also provide data on the number of applications processed, number of fair hearings, and fraud control activity. FNS uses the data to monitor State agency activity levels and performance. If the information were not collected it would disrupt budget planning and delay appropriation distributions. *Description of Respondents:* State, Local or Tribal Government. *Number of Respondents:* 53. *Frequency of Responses:* Recordkeeping; Reporting: Annually. *Total Burden Hours:* 2,849. Ruth Brown, Departmental Information Collection Clearance Officer. [FR Doc. E7-14472 Filed 7-25-07; 8:45 am] BILLING CODE 3410-30-P DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request July 23, 2007. The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments regarding
(a)whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(b)the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used;
(c)ways to enhance the quality, utility and clarity of the information to be collected;
(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 should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), *OIRA_Submission@OMB.EOP.GOV* or fax
(202)395-5806 and to Departmental Clearance Office, USDA, OCIO, Mail Stop 7602, Washington, DC 20250-7602. Comments regarding these information collections are best assured of having their full effect if received within 30 days of this notification. Copies of the submission(s) may be obtained by calling
(202)720-8958. An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number. Farm Service Agency *Title:* Application for Payment of Amounts Due Persons Who Have Died, Disappeared or Declared Incompetent. *OMB Control Number:* 0560-0026. *Summary of Collection:* Representatives or survivors of producers who die, disappear, or are declared incompetent must be afforded a method of obtaining any payment intended for the producer. 7 CFR part 707 provides that form, FSA-325, be used as the form of application for a person desiring to claim such payments. It is necessary to collect information recorded on FSA-325 in order to determine whether representatives or survivors of a producer are entitled to receive payments earned by a producer who dies, disappears, or is declared incompetent before receiving the payments due. *Need and Use of the Information:* FSA will collect information to determine if the survivors have rights to the existing payments or to the unpaid portions of the producer's payments. *Description of Respondents:* Individuals or households. *Number of Respondents:* 2,000. *Frequency of Responses:* Reporting: Other (when necessary). *Total Burden Hours:* 3,000. Ruth Brown, Departmental Information Collection Clearance Officer. [FR Doc. E7-14474 Filed 7-25-07; 8:45 am] BILLING CODE 3410-05-P DEPARTMENT OF AGRICULTURE Farm Service Agency Information Collection: Emergency Conservation Program AGENCY: Farm Service Agency, USDA. ACTION: Notice; request for comments. SUMMARY: In accordance with the Paperwork Reduction Act of 1995, the Farm Service Agency
(FSA)is seeking comments from all interested individuals and organizations on the revision of currently approved information collection associated with the Emergency Conservation Program (ECP). DATES: Comments on this notice must be received on or before September 24, 2007 to be assured consideration. ADDRESSES: We invite you to submit comments on this Notice. In your comment, include the volume, date, and page number of this issue of the **Federal Register** . You may submit comments by any of the following methods: *E-mail:* Send comments to: *Clayton.Furukawa@wdc.usda.gov.* *Fax:*
(202)720-4619. *Mail:* Farm Service Agency, USDA, Attn: Clayton Furukawa, ECP Program Manager, Conservation and Environmental Programs Division, USDA, FSA, STOP 0513, 1400 Independence Avenue, SW., Washington, DC 20250-0513. Comments also should be sent to the Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget, Washington, DC 20503. FOR FURTHER INFORMATION CONTACT: Clayton Furukawa, ECP Program Manager,
(202)690-0571. SUPPLEMENTARY INFORMATION: Description of Information Collection *Title:* Emergency Conservation Program. *OMB Control Number:* 0560-0082. *Expiration Date:* February 28, 2010. *Type of Request:* Revision of a Currently Approved Information Collection. *Abstract:* This information collection is to allow FSA to effectively administer the regulations under the ECP. The regulations at 7 CFR part 701 set forth basic policies, program provisions, and eligibility requirements for owners and operators to enter into agreement with to apply for financial and technical assistance and for receiving cost-share payments under the ECP. The revision to the currently approved information collection is in response to, and consistent with, the new requirement that an Adjusted Gross Income Limitation be used when determining the eligibility of certain respondents who wish to participate in the ECP, pursuant to the provisions of Section 9004(b) of Public Law 110-28. *Estimate of Burden:* Public reporting burden for this collection of information is estimated to average .25 hours (15 minutes) per response. The average travel time, which is included in the total annual burden, is estimated to be 1 hour per respondent. *Respondents:* Owners, operators and other eligible agricultural producers on eligible farmland. *Number of Respondents:* 90,000. *Estimated Annual Number of Respondents:* 90,420. *Estimated Number of Responses per Respondent:* 1. *Estimated Total Annual Burden on Respondents:* 67,610. Comments Comments are invited on:
(1)Whether this collection information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2)The accuracy of the agency's estimate of burden, including the validity of the methodology and assumptions used;
(3)Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4)Ways to minimize the burden of the collection of the information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. All comments received in response to this notice, including names and addresses when provided, will be a matter of public records. Comments will be summarized and included in the submission for Office of Management and Budget approval. Signed at Washington, DC, on July 19, 2007. Glen L. Keppy, Acting Administrator, Farm Service Agency. [FR Doc. E7-14385 Filed 7-25-07; 8:45 am] BILLING CODE 3410-05-P DEPARTMENT OF AGRICULTURE Notice of Intent To Prepare an Environmental Impact Statement AGENCY: Forest Service, USDA. PROJECT: Corralled Bear, Clearwater National Forest, Latah County, ID. ACTION: Notice of intent to prepare an environmental impact statement. SUMMARY: The USDA, Forest Service, will prepare an Environmental Impact Statement
(EIS)to disclose the environmental effects of timber harvest, prescribed fire, fuels reduction, watershed restoration, and access management activities in the Corralled Bear project area on the Palouse Ranger District of the Clearwater National Forest. The Corralled Bear project area is located north of the towns of Deary and Helmer within the East Fork of Big Bear Creek and Corral Creek drainages, approximately 21 air-miles northeast of the town of Moscow, Idaho. DATES: This project was previously scoped in March 2006, and the comments received will be included in the documentation for the EIS. A 45-day public comment period will follow the release of the draft environmental impact statement
(DEIS)that is expected in September 2007. The final environmental impact statement
(FEIS)and Record of Decision
(ROD)is expected in February 2008. SUPPLEMENTARY INFORMATION: The Corralled Bear project area contains approximately 11,318 acres, which is all National Forest lands except for 160 acres of private land. The project area is located in portions of T40N, R1W; T40N, R2W; T41N, R1W; and T41N, R2W, Boise Meridian, Latah County, Idaho. The proposed actions would occur on National Forest lands and are all outside the boundaries of any inventoried roadless area or any areas considered for inclusion to the National Wilderness System as recommended by the Clearwater National Forest Plan or by any past or present legislative wilderness proposals. *Purpose and Need for Action* is to:
(1)Promote stand productivity, restore vegetative successional stages to reflect historical patch sizes and locations, and restore blister rust resistant white pine;
(2)reduce fuel buildup in stands where fire suppression has interrupted the short-return fire interval and resulted in unnaturally high amounts of fuel and overgrown understory, and create a more defensible space to control wildfire on Forest Service land adjacent to private property;
(3)reduce long-term sedimentation to streams caused by existing unsurfaced roads, and stabilize stream banks made unstable by motorized vehicles, cattle trailing, and channelization (historic railroad grades);
(4)update fish/water quality standards for Corral Creek in Appendix K of the Clearwater Forest Plan to better meet the Clean Water Act standards supporting fisheries and reflect better information on fisheries collected in stream surveys; and
(5)provide for a reasonable level of off-highway vehicle
(OHV)access, reduce user conflicts, and provide the necessary resource protection required by law, regulation, and good stewardship practices. *The Proposed Action* would consist of timber harvest on about 812 acres, using improvement cuts, commercial thinning, and regeneration harvest methods. Some regeneration harvests could create openings exceeding 40 acres in size; however, all harvest will retain some healthy trees and replacement snags for structural diversity. Road activities associated with the timber sales would include reconstructing about 2.4 miles of existing roads and constructing 3.6 miles of temporary road (to be decommissioned after harvest activity). About 8.6 miles of open roads would be treated on each side to reduce fuel concentrations and ladder fuels. Watershed improvements would include 8.2 miles of road decommissioning, putting 14.4 miles of existing roads into intermittent stored service (self-maintaining), and installation of a rocked cattle crossing. Access management would consist of designating existing suitable OHV routes for future use and managing area roads and trails based on a Roads Analysis. Other components of the proposed action include designating areas to be managed for old growth and making a Forest Plan Amendment to raise the fish/water quality standards on Corrall Creek to incorporate better information on fish and their habitat. *Possible Alternatives* the Forest Service will consider include the “no action ” alternative in which none of the proposed activities would be implemented. Additional alternatives being considered include an alternative that does not build any new roads, an alternative that does not create any openings by utilizing only intermediate (non-regeneration) type harvests like thinnings and improvement cuts, an alternative that promotes patch placement for maximum wildlife and biological benefits, an alternative that does not include a Forest Plan Amendment to increase the fish and water standard for Corral Creek, and an alternative that only includes activities that would help stabilize watershed conditions, such as road obliteration, stream bank stabilization and OHV use management. *The Scoping Process* was initiated with the release of a Scoping Letter on March 29, 2006. Comments received as a result of that effort will be included in the documentation for the EIS. Additional public input will be solicited following the release of the DEIS. This proposal also includes six openings greater than 40 acres in size that would be created by timber harvest. A 60-day public review of the proposed openings will be initiated by public notice in the newspaper of record. *Preliminary Issues* that could be affected by proposed activities include: Access management, air quality, economic feasibility, fish habitat, heritage resources, sensitive and management indicator species of wildlife, sensitive plants, snag habitat, soil productivity, spread of noxious weeds, tribal treaty rights, and water quality. Issues expected not to be affected by the proposal include impacts of grazing, old growth habitat, risk of landslides, and threatened and endangered wildlife and plant species. Issues identified through previous scoping and found to be outside the scope of the project or not consistent with Forest Plan standards include using prescribed fire instead of timber harvest for vegetative treatments within the E1 management area and evaluating cattle grazing laws. *Early Notice of Importance of Public Participation in Subsequent Environmental Review:* A draft environmental impact statement will be prepared for comment. The comment period on the draft environmental impact statement will be 45 days from the date the Environmental Protection Agency publishes the notice of availability in the **Federal Register.** The Forest Service believes, at this early stage, it is important to give reviewers notice of several court rulings related to public participation in the environmental review process. First, reviewers of draft environmental impact statements must structure their participation in the environmental review of the proposal so that it is meaningful and alerts an agency to the reviewer's position and contentions. *Vermont Yankee Nuclear Power Corp* . v. *NRDC* , 435 U.S. 519, 553 (1978). Also, environmental objections that could be raised at the draft environmental impact statement stage but that are not raised until after completion of the final environmental impact statement may be waived or dismissed by the courts. *City of Angoon* v. *Hodel* , 803 F.2d 1016, 1022 (9th Cir. 1986) and *Wisconsin Heritages, Inc.* v. *Harris* , 490 F. Supp. 1334, 1338 (E.D. Wis. 1980). Because of these court rulings, it is very important that those interested in this proposed action participate by the close of the 45-day comment period so that substantive comments and objections are made available to the Forest Service at a time when it can meaningfully consider them and respond to them in the final environmental impact statement. To assist the Forest Service in identifying and considering issues and concerns on the proposed action, comments on the draft environmental impact statement should be as specific as possible. It is also helpful if comments refer to specific pages or chapters of the draft statement. Comments may also address the adequacy of the draft environmental impact statement or the merits of the alternatives formulated and discussed in the statement. Reviewers may wish to refer to the Council on Environmental Quality Regulations for implementing the procedural provisions of the National Environmental Policy Act at 40 CFR 1503.3 in addressing these points. Comments received, including the names and addresses of those who comment, will be considered part of the public record on this proposal and will be available for public inspection. (Authority: 40 CFR 1501.7 and 1508.22; Forest Service Handbook 1909.15, Section 21) *The Responsible Official* for this project is the Forest Supervisor of the Clearwater National Forest, 12730 Highway 12, Orofino, ID 83544. The Responsible Official will decide if the proposed project will be implemented and will document the decision and reasons for the decision in a Record of Decision. That decision will be subject to Forest Service Appeal Regulations. The responsibility for preparing the DEIS and FEIS has been delegated to Kara Chadwick, District Ranger, Palouse Ranger District. ADDRESSES: Written comments and suggestions concerning this project should be sent to: Kara Chadwick, District Ranger, Palouse Ranger District, 1700 Highway 6, Potlatch, ID 83855 or e-mailed to: *comments-northern-clearwater-palouse@fs.fed.us* . FOR FURTHER INFORMATION CONTACT: Tam White; Project Leader, North Fork Ranger District, at: *twhite@fs.fed.us* or phone:
(208)476-4541. Dated: July 19, 2007. Thomas K. Reilly, Forest Supervisor. [FR Doc. 07-3653 Filed 7-25-07; 8:45 am]
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U.S. Code
- Public information; agency rules, opinions, orders, records, and proceedings§ 552
- Federal Aviation Administration§ 106
- Designated new animal drugs for minor use or minor species§ 360ccc–2
- Conditional approval of new animal drugs for minor use and minor species and certain new animal drugs§ 360ccc
- Regulations and hearings§ 371
- Disclosure of confidential information generally§ 1905
- Research and investigations generally§ 241
- Definitions; generally§ 321
- Rule making§ 553
- Avoidance of duplicative or unnecessary analyses§ 605
- Establishment, functions, and activities§ 272
- Definitions§ 601
- Purposes§ 3501
- SHORT TITLE.§ 801
- EXPEDITED PROCESSING OF REQUESTS FOR JAPANESE IMPERIAL GOVERNMENT RECORDS.§ 804
- Congressional findings and declaration of purpose§ 7401
- Contract, grant, and cooperative agreement authorities§ 3318
- Federal procurement§ 6962
- Restriction on treatment of indirect costs and tuition remission§ 3319
- Land grant aid of colleges§ 301
- Congressional statement of findings§ 205a
- Congressional statement of policy§ 2131
- Utilization of Federal technology§ 3710
- Findings, purposes and policy§ 1801
- Short title§ 51
register
CFR
- Applications.§ 514.1
- Records and reports concerning experience with approved new animal drugs.§ 514.80
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- May I fly my aircraft to a repair facility to do the work required by an airworthiness directive?§ 39.23
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statutes-at-large
69 references not yet in our index
- 10 CFR 171
- 14 CFR 97
- 1 CFR 51
- Pub. L. 108-282
- 21 CFR 520
- 21 CFR 522
- 21 CFR 524
- 21 CFR 526
- 21 CFR 529
- 21 CFR 558
- 5 USC 601-612
- Pub. L. 104-4
- 21 CFR 516
- 21 CFR 20
- 21 CFR 510
- 19 USC 2531-2582
- 21 USC 321-393
- 21 CFR 514
- 26 CFR 301
- T.D. 9333
- Pub. L. 110-28
- 121 Stat. 190
- 33 CFR 100
- Pub. L. 104-121
- 44 USC 3501-3520
- 2 USC 1531-1538
- 42 USC 4321-4370f
- 33 USC 1233
- 40 CFR 70
- 7 CFR 550
- Pub. L. 99-198
- 2 CFR 215
- 7 CFR 3052
- 31 CFR 205
- 7 CFR 3019
- 7 CFR 3015
- Pub. L. 95-113
- Pub. L. 97-98
- 37 CFR 401
- 7 CFR 3017
+ 29 more
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cites case law
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Final rule; correction
SCOTUS435 U.S. 519
F. App'x803 F.2d 1016
F. Supp.490 F. Supp. 1334
Cites 108 · showing 12Cited by 0 across 0 sources