section_id,title_number,title_name,chapter,subchapter,part_number,part_name,subpart,subpart_name,section_number,section_heading,agency,authority,source_citation,amendment_citations,full_text 10:10:5.0.2.5.23.1.16.1,10,Energy,III,,800,PART 800—LOANS FOR BID OR PROPOSAL PREPARATION BY MINORITY BUSINESS ENTERPRISES SEEKING DOE CONTRACTS AND ASSISTANCE,A,Subpart A—General,,§ 800.001 Purpose.,DOE,,,"[48 FR 17574, Apr. 25, 1983]","The purpose of this regulation is to set forth policies and procedures for the award and administration of loans to minority business enterprises. The loans are to assist such enterprises in participating fully in research, development, demonstration and contract activities of the Department of Energy. The loans are to defray a percentage of the cost of obtaining DOE contracts and other agreements, including procurements, cooperative agreements, grants, loans and loan guarantees; of obtaining subcontracts with DOE operating contractors; and of obtaining contracts with first-tier subcontractors of DOE operating contractors in furtherance of the research, development, demonstration or other contract activities of DOE. Issuance of loans under this regulation is limited to the extent funds are provided in advance in appropriation acts. This regulation implements the authority for such loans in section 211(e) of the Department of Energy (DOE) Organization Act, Public Law 95-619, title VI, section 641, November 9, 1978, 92 Stat. 3284 (42 U.S.C.A. 7141)." 10:10:5.0.2.5.23.1.16.2,10,Energy,III,,800,PART 800—LOANS FOR BID OR PROPOSAL PREPARATION BY MINORITY BUSINESS ENTERPRISES SEEKING DOE CONTRACTS AND ASSISTANCE,A,Subpart A—General,,§ 800.002 Program management.,DOE,,,,Program management responsibility for financial assistance awarded under this regulation has been assigned to the Office of Minority Economic Impact. 10:10:5.0.2.5.23.1.16.3,10,Energy,III,,800,PART 800—LOANS FOR BID OR PROPOSAL PREPARATION BY MINORITY BUSINESS ENTERPRISES SEEKING DOE CONTRACTS AND ASSISTANCE,A,Subpart A—General,,§ 800.003 Definitions.,DOE,,,"[46 FR 44689, Sept. 4, 1981, as amended at 48 FR 17574, Apr. 25, 1983]","For the purpose of this regulation: Act means the DOE Organization Act, Public Law 95-91, title II, as amended by the National Energy Conservation Policy Act, Public Law 95-619, title VI, section 641. Applicant means a minority business enterprise which is seeking a loan under this regulation. Application Approving Official means the Director of the Office of Minority Economic Impact. Application Evaluation Panel (also referred to as the Panel ) means a team of Federal employees appointed by the Application Approving Official to evaluate loan applications and make approval or disapproval recommendations regarding such applications. Borrower means an applicant who enters into a loan agreement with DOE. Contracting Officer means the DOE official warranted and authorized to contractually bind the Department of Energy and execute written agreements that are binding on the Department. Costs of a bid or proposal means the cost of preparing, submitting and supporting a bid or proposal, whether solicited or not, for a DOE contract or other agreement such as a procurement contract, grant, cooperative agreement, loan or loan guarantee; or a subcontract with a DOE operating contractor; or a contract with a first-tier subcontractor of a DOE operating contractor in furtherance of the research, development, demonstration or other contract activities of DOE. Default means the actual failure by the borrower to make payment of principal or interest in accordance with the terms and conditions of a loan issued under this regulation, or the failure of the borrower to meet any other requirement specified as a default condition in the loan agreement. Director means the Director of the Office of Minority Economic Impact (OMEI). Loan, in reference to a loan made pursuant to the regulation, means a transaction in which a contractual instrument (“loan agreement”) is executed between the United States, as lender, acting through the Secretary of Energy, and a borrower. The instrument must obligate the United States to provide the borrower with a specified amount(s) of United States funds for a specified period of time and must obligate the borrower to use the moneys to bid for and attempt to obtain contracts and other agreements relating to DOE research, development, demonstration and contract activities, and to repay the moneys at a specified time at an agreed rate of interest. The words ‘loan’, ‘loan agreement’ and ‘transaction’ include (where the context does not require otherwise) the terms and conditions of related documents, such as the borrower's note or bond or other evidence of, or security for, the borrower's indebtedness. Minority Business Enterprise means a firm including a sole proprietorship, corporation, association, or partnership which is at least 50 percent owned or controlled by a member of a minority or group of members of a minority. For the purpose of this definition, ‘control’ means direct or indirect possession of the power to direct, or cause the direction of, management and policies, whether through the ownership of voting securities, by contract or otherwise. An individual who is a citizen of the United States and who is a Negro, Puerto Rican, American Indian, Eskimo, Oriental, or Aleut, or is a Spanish speaking individual of Spanish descent, is a member of a “minority” as used in this regulation. Operating Contractors means contractors under contracts having one of the following purposes, in accordance with the provisions of § 9.50.001(a)(1) of the DOE procurement regulations (title 41 CFR part 9-50): (a) DOE prime contracts for the management of Federal Government-owned laboratories, production plants, and research facilities located on Federal Government-owned or Federal Government-leased sites, where the programs being conducted are considered of a long-term, continuing nature; or (b) DOE prime contracts for the operation of Federal Government-owned facilities located on contractor-owned or leased sites where the programs being conducted are of a long-term, continuing nature. An example of this category would be those contracts with universities for the operation of Federal Government-owned facilities, for the purpose of conducting long-term basic research programs. (c) Other contracts performed on sites owned by the Federal Government when so designated by the appropriate procurement official. Secretary means the Secretary of the Department of Energy or his delegate." 10:10:5.0.2.5.23.1.16.4,10,Energy,III,,800,PART 800—LOANS FOR BID OR PROPOSAL PREPARATION BY MINORITY BUSINESS ENTERPRISES SEEKING DOE CONTRACTS AND ASSISTANCE,A,Subpart A—General,,§ 800.004 Eligibility.,DOE,,,,"In order to be eligible for a loan, an applicant must be a minority business enterprise as defined in § 800.003." 10:10:5.0.2.5.23.2.16.1,10,Energy,III,,800,PART 800—LOANS FOR BID OR PROPOSAL PREPARATION BY MINORITY BUSINESS ENTERPRISES SEEKING DOE CONTRACTS AND ASSISTANCE,B,"Subpart B—Loan Solicitation, Application and Review",,§ 800.100 Solicitation of applications.,DOE,,,"[46 FR 44689, Sept. 4, 1981, as amended at 48 FR 17574, Apr. 25, 1983]","The Secretary will periodically issue an announcement soliciting applications under this regulation. The announcement will be published in the Federal Register, synopsized in the Commerce Business Daily, and circulated to minority trade associations and organizations and to the Minority Business Development Agency and Small Business Administration. The announcement will indicate funds availability, eligibility requirements, application instructions, interest rates, maturities and other key loan terms and any applicable restrictions. In such solicitations, DOE shall further indicate that, in the case of applications for loans relating to bids or proposals for contracts with first-tier subcontractors of DOE operating contractors, information necessary to substantiate such applications may be unavailable to DOE from such subcontractors. If the substantiating information is not made available to DOE in a timely manner, the application may be rejected." 10:10:5.0.2.5.23.2.16.2,10,Energy,III,,800,PART 800—LOANS FOR BID OR PROPOSAL PREPARATION BY MINORITY BUSINESS ENTERPRISES SEEKING DOE CONTRACTS AND ASSISTANCE,B,"Subpart B—Loan Solicitation, Application and Review",,§ 800.101 Application requirements.,DOE,,,,"(a) Applications for loans shall be filed, one original and three copies with: Department of Energy, Washington, DC 20585, Attention: Announcement No. DE-PS60-MI. (b) An application for a loan under this regulation must include the following information. Items described in paragraphs (b)(1) through (7) of this section may be submitted for preliminary review in advance of a specific loan request but must be updated at time of loan request to reflect substantial changes. (1) Applicant's name and address, with a description of the kind and size of its business, its business experience and its history as a minority business enterprise. (2) Financial statements of applicant and its principals, including source of revenue and balance sheets for the current year and, as to applicant, for the two preceding years of applicant's existence as a business entity. The Secretary may require applicant to provide certification by a public accountant, or other certification acceptable to the Secretary. (3) A description of any other Federal financial backing (direct loans, guaranteed loans, grants, etc.) applied for or obtained by the applicant within the previous five years, or expected to be applied for. (4) A description of applicant's management structure, with list of applicant's key persons with their responsibilities and qualifications. (i) In the case of a specific loan request this list should include any contractor or consultant whose services are proposed in connection with the bid or proposal for which the loan is sought. (5) Affidavit(s) of eligibility (see § 800.004). (6) Documentation as to applicant's authority to undertake the activities contemplated by the application. Such documentation shall take substantially the following form: (i) If the applicant is a corporation, a copy of the charter or certificate and articles of incorporation, with any amendments, duly certified by the Secretary of State of the State where organized, and a copy of the by-laws. There shall also be included a copy of all minutes, resolutions of stockholders or directors or other representatives of the applicant, properly attested, authorizing the filing of the application. (ii) If the applicant is an association, a verified copy of its articles of association, if any, with an attested copy of the resolution of its governing board, if any, authorizing the filing of the application. (iii) If the applicant is a business trust, a verified copy of the trust instrument and an attested copy of the resolution or other authority under which the application is made. (iv) If the applicant is a joint stock company, a verified copy of the articles of association and of the authorizing resolution. (v) If the application is made on behalf of a partnership, a copy of the partnership agreement, if any; if on behalf of a limited partnership, a duly certified copy, also, of the certificate of limited partnership, if such certificate is required to be obtained under state law governing such limited partnership. (7) Credit references. (8) Information on the award to be sought through the bid or proposal, as follows: (i) Title, and whether in response to a solicitation or unsolicited. (ii) Brief description of work to be performed. (iii) Sponsoring DOE office, including solicitation number, if any. (iv) If an unsolicited proposal is planned, the loan application shall indicate the appropriate DOE program personnel to be consulted as to whether there is potential for the proposal to be supported. (v) Schedule for preparation and submission of the bid or proposal. (9) Itemized cost estimates (and whether yet incurred). (10) The required loan amount, not to exceed 75 percent of total bid or proposal costs, in accordance with § 800.200 on allowable costs. (11) Requested loan maturity, in accordance with § 800.202(a)(3). (12) How applicant will finance performance of work under a successful bid or proposal. (13) Such other information as the Application Approving Official may deem necessary for evaluation in accordance with § 800.103 and for compliance with the provisions of this regulation. (14) The application shall be signed by the applicant or on behalf of the applicant by an authorized representative. Verification may be by affidavit of an authorized representative of an applicant; attestation shall be by the authorized officer of an applicant. Title 18 United States Code, section 1001 provides criminal penalties for fraud and intentional false statements in information submitted in such an application." 10:10:5.0.2.5.23.2.16.3,10,Energy,III,,800,PART 800—LOANS FOR BID OR PROPOSAL PREPARATION BY MINORITY BUSINESS ENTERPRISES SEEKING DOE CONTRACTS AND ASSISTANCE,B,"Subpart B—Loan Solicitation, Application and Review",,§ 800.102 Review by Application Evaluation Panel.,DOE,,,,"(a) Applications for loans under this regulation shall be reviewed by an Application Evaluation Panel, which shall be appointed by the Application Approving Official. The Panel shall include, at a minimum, a representative of the Office of Minority Economic Impact, the contracting officer and a representative of the Office of the Controller. (b) Panel review shall be conducted pursuant to paragraph (c) or (d) of this section, as applicable, to evaluate, to clarify and to develop information contained in the application and such other information as the Application Approving Official or the Panel may request. (1) The Panel shall give priority to applications relating to a competitive solicitation, because of time limits on such solicitations. The Panel may defer action a maximum of five days after a solicitation has been announced in the Commerce Business Daily to provide all interested applicants an opportunity to apply. (2) Initial screening will be in the order applications are received, but time required to process an application may vary from case to case. (c) Panel review of specific loan requests. (1) If an application contains a specific loan request, and complies with § 800.101, the Panel shall arrange for risk analysis, independent of any such analysis submitted by or on behalf of the applicant. Risk analysis shall be directed both to the loan request and to applicant's prospective performance of work pursuant to the bid or proposal. (2) The Panel shall evaluate the loan request in light of the risk analysis, and shall give its conclusions in writing to the Application Approving Official, with respect to the following and to such other considerations as that official may direct: (i) Applicant's eligibility as a minority business enterprise. (ii) Compliance with the application requirements of § 800.101. (iii) Compliance with § 800.200 on allowable costs. (iv) Applicant's financial ability to make the bid or proposal without the loan. (v) Applicant's contribution of, or ability to contribute, the 25% minimum share of allowable costs, or more. (vi) Applicant's ability to prepare an adequate bid or proposal, if the loan is made. (vii) Possibility of award to applicant pursuant to its bid or proposal. Normally, not more than three loans will be approved for the same competitive award. (viii) Applicant's ability to perform pursuant to the bid or proposal. (ix) Likelihood that applicant will repay the requested loan, regardless of success of applicant's bid or proposal. (x) Optimal use of available program funds. (xi) The Panel's recommendation. (d) Panel review of other applications. If the application was submitted without a specific loan request, the Panel shall review the application in accordance with paragraph (b) of this section with the limited purpose of determining whether the applicant has complied with § 800.101, except as to matters determinable only with respect to a future specific loan request, and shall inform the Application Approving Official in writing as to its determinations." 10:10:5.0.2.5.23.2.16.4,10,Energy,III,,800,PART 800—LOANS FOR BID OR PROPOSAL PREPARATION BY MINORITY BUSINESS ENTERPRISES SEEKING DOE CONTRACTS AND ASSISTANCE,B,"Subpart B—Loan Solicitation, Application and Review",,§ 800.103 Review by Application Approving Official.,DOE,,,,"(a) The Application Approving Official shall consider the results of the Panel's review under section 102 (c) or (d), and such other information as the Application Approving Official determines to be relevant pursuant to the provisions of this regulation, and shall either approve or disapprove the application, giving it priority in accordance with the provisions of § 800.102(b). (b) The Application Approving Official shall authorize a contracting officer to notify the applicant of approval or disapproval. (c) An applicant whose application has been rejected will be informed, on request, of the reason for rejection. Rejection is not a bar to submission of an appropriately revised application." 10:10:5.0.2.5.23.3.16.1,10,Energy,III,,800,PART 800—LOANS FOR BID OR PROPOSAL PREPARATION BY MINORITY BUSINESS ENTERPRISES SEEKING DOE CONTRACTS AND ASSISTANCE,C,Subpart C—Loans,,§ 800.200 Maximum loan; allowable costs.,DOE,,,"[46 FR 44689, Sept. 4, 1981, as amended at 48 FR 17574, Apr. 25, 1983]","(a) A loan under this regulation shall not exceed 75 percent of allowable costs of a bid or proposal to obtain a DOE contract or other agreement (such as a procurement contract, cooperative agreement, grant, loan or loan guarantee), or a subcontract with a DOE operating contractor, or a contract with a first-tier subcontractor of a DOE operating contractor in furtherance of the research, development, demonstration or other contract activities of DOE. (b) To be allowable, costs must, in DOE's judgment: (1) Be consistent with the bidding cost principles of the Federal Procurement Regulation (41 CFR Ch. 1, 1-15.205-3) and DOE Procurement Regulation (41 CFR Ch. 9, 9-15.205-3); and; (2) Be necessary, reasonable and customary for the bid or proposal contemplated by the application; and (3) Be incurred, or expected to be incurred, by the applicant. (c) Costs which are, in general, allowable, if consistent with paragraph (b) of this section include, but are not limited to: (1) Bid bond premiums. (2) Financial, accounting, legal, engineering and other professional, consulting or similar fees and service charges. (3) Printing and reproduction costs. (4) Travel and transportation costs. (5) Costs of the loan application under this rule. (d) Costs that are not considered as allowable costs include the following: (1) Fees and commissions charged to the applicant, including finder's fees, for obtaining Federal funds. (2) Expenses, which, in DOE's judgment, have primarily an application broader than the specific loan request. (3) Costs which, in DOE's judgment, fail to conform to paragraph (b) of this section." 10:10:5.0.2.5.23.3.16.2,10,Energy,III,,800,PART 800—LOANS FOR BID OR PROPOSAL PREPARATION BY MINORITY BUSINESS ENTERPRISES SEEKING DOE CONTRACTS AND ASSISTANCE,C,Subpart C—Loans,,§ 800.201 Findings.,DOE,,,"[46 FR 44689, Sept. 4, 1981, as amended at 48 FR 17574, Apr. 25, 1983]","A loan shall issue under this regulation only if the Secretary, having reviewed the action of the Application Approving Official, and having considered such other information as the Secretary may deem pertinent, has made all the findings that follow: (a) That the applicant is a minority business enterprise. (b) That the loan will assist the enterprise to participate in the research, development, demonstration or contract activities of the Department of Energy by providing funds needed by applicant for bid or proposal purposes. (c) That, by terms of the loan, applicant's use of the funds will be limited to bidding for and obtaining a contract or other agreement with the Department of Energy, a subcontract with a DOE operating contractor, or a contract with a first-tier subcontractor of a DOE operating contractor in furtherance of the research, development, demonstration or other contract activities of DOE. (d) That the funds to be loaned will not exceed 75% of applicant's costs in bidding for and obtaining the contract or agreement. (e) That the rate of interest on the loan has been determined in consultation with the Secretary of the Treasury. (f) That there is a reasonable prospect that the applicant will make the bid or proposal which is the purpose of the loan, will perform according to its bid or proposal, and will repay the loan according to the terms thereof, regardless of the success of its bid or proposal. (g) That the terms and conditions of the loan are acceptable to the Secretary and comply with this regulation and with section 211(e) of the Department of Energy Organization Act." 10:10:5.0.2.5.23.3.16.3,10,Energy,III,,800,PART 800—LOANS FOR BID OR PROPOSAL PREPARATION BY MINORITY BUSINESS ENTERPRISES SEEKING DOE CONTRACTS AND ASSISTANCE,C,Subpart C—Loans,,§ 800.202 Loan terms and conditions.,DOE,,,,"(a) The loan shall be based upon a loan agreement and the borrower's separate promissory note for the proceeds of the loan, including interest. The agreement and note shall be executed in writing between the borrower and the Secretary. The contracting officer shall execute the loan agreement on behalf of the Secretary. The loan agreement and the promissory note shall provide as follows, either at full length or by incorporation by reference to terms of the other of the two documents. (1) The borrower agrees to repay the loan of funds provided by the Secretary. (2) The interest rate on the loan is as established in consultation with the Secretary of the Treasury, taking into consideration the current average market yields of outstanding marketable obligations of the United States having maturities comparable to the loan. (3) The loan shall be repaid over a maximum period as follows, in equal monthly installments of principal and interest, unless a different frequency of installments is specified by the Secretary: 1 Maximum repayment period from date of initial disbursement. Repayment of principal and interest shall begin within 90 days following the initial loan disbursement or such longer period as may be acceptable to the Secretary. Installments shall be applied to accrued interest first and then to repayment of principal. Past due installments shall accrue interest at the quarterly current-value-of-funds-rate specified by the Treasury for overdue accounts. Prepayments may be made at any time without penalty. (4) The borrower shall have appropriate opportunities, as specified in the loan agreement, to cure any default, failure, or breach of any of the covenants, conditions and obligations undertaken by the borrower pursuant to the provisions of the loan agreement. (5) Loans of $10,000 or less will be disbursed in a single disbursement. Disbursement of loans larger than $10,000 shall be per schedule and documentation specified by the Secretary. (6) The loan may be used by the borrower to defray as much as, but no more than, 75 percent of the cost of the bid or proposal within the limitations specified in § 800.200, on allowable costs. Costs incurred by the borrower prior to the effective date of the loan agreement, and allowable under § 800.200, may be credited toward the borrower's share of costs if, in DOE's judgment, they were primarily related to the bid or proposal, but shall not be reimbursed from the loan. (7) The borrower shall make periodic reports regarding the bid or proposal. (8) The borrower shall maintain good standing under Federal, State and local laws and regulations applicable to the conduct of its business, including current payment of all taxes, fees and other charges and all requisite licenses and other governmental authorization necessary for the continued operation of the business throughout the term of the loan. (9) The borrower shall remain a minority business enterprise throughout the term of the loan. (10) The borrower shall return funds disbursed, but not required together with accrued interest thereon, to DOE, or to the servicing agent, if applicable, when its bid or proposal is ready for submission. The return of unrequired funds shall be by check separate from any payment of interest or principal, shall be identified by the borrower as a return of unrequired funds, and shall be accompanied by the borrower's certification that so much of the loan as has been disbursed to the borrower and not returned has been, or will be, expended by the borrower for costs allowable under § 800.200. (11) Such other provisions as the Secretary deems appropriate. (b) The loan agreement shall also provide for loan servicing and monitoring in accordance with § 800.300 and § 800.301, loan limitation in accordance with § 800.302, assignment and transfer in accordance with § 800.303, default in accordance with § 800.304 and appeals in accordance with § 800.307. (c) The Secretary may require, as preconditions to disbursement, that the borrower have specified amounts of working capital (including amounts derived from Federal financial assistance) and maintain specified financial ratios, where in the Secretary's judgment satisfaction of such preconditions is necessary to assure the borrower's ability to make and perform the contract, agreement or subcontract according to the bid or proposal, or is otherwise necessary to protect the interests of the United States. (d) The Secretary may require pledges, personal guarantees and other collateral security, and the maintenance of insurance on the borrower's assets and principals, in amounts and on terms appropriate in the Secretary's judgment, to protect the interests of the United States." 10:10:5.0.2.5.23.3.16.4,10,Energy,III,,800,PART 800—LOANS FOR BID OR PROPOSAL PREPARATION BY MINORITY BUSINESS ENTERPRISES SEEKING DOE CONTRACTS AND ASSISTANCE,C,Subpart C—Loans,,§ 800.203 Loan limits.,DOE,,,,"The Secretary shall not make a loan in excess of $50,000, or make aggregate loans to the same minority business enterprise, including its affiliates, in any Federal fiscal year in excess of $100,000. In addition, the Secretary shall not increase a loan to an amount which would cause the limits set forth in the previous sentence to be exceeded. Nothing in this regulation shall be interpreted to restrict the Secretary, in making the various determinations provided for in this regulation, from taking into account considerations relating to the Office of Minority Economic Impact loan program as a whole." 10:10:5.0.2.5.23.3.16.5,10,Energy,III,,800,PART 800—LOANS FOR BID OR PROPOSAL PREPARATION BY MINORITY BUSINESS ENTERPRISES SEEKING DOE CONTRACTS AND ASSISTANCE,C,Subpart C—Loans,,§ 800.204 Deviations.,DOE,,,,"(a) To the extent consistent with the Act, relevant appropriations acts, and other applicable statutes, DOE may deviate on an individual application basis from the requirements of this regulation upon a finding by the Secretary that such deviation is necessary or appropriate in the individual case for the accomplishment of program objectives. (b) The contracting officer may, subject to written agreement by other necessary parties, modify or amend the terms and conditions of a loan provided that such modification or amendment shall be consistent with this regulation." 10:10:5.0.2.5.23.4.16.1,10,Energy,III,,800,PART 800—LOANS FOR BID OR PROPOSAL PREPARATION BY MINORITY BUSINESS ENTERPRISES SEEKING DOE CONTRACTS AND ASSISTANCE,D,Subpart D—Loan Administration,,§ 800.300 Loan servicing.,DOE,,,,"(a) Servicing of a loan under this regulation may be performed by DOE, by another Federal agency, or by a servicing agent (commercial bank, broker, or other financial institution or entity) having the capability, and legally qualified, to service the loan consistently with the requirements of this regulation, which contracts with DOE to act as servicing agent. In determining the capability of a prospective servicing agent, DOE shall give due consideration to the experience of the agent in providing financial services to minority business enterprises. (b) If the servicing of the loan is by contract or other agreement, such contract or other agreement shall provide that the loan shall be serviced in accordance with this regulation and with the terms and conditions of the loan, under a standard of performance that a reasonable and prudent lender would require as to its own similar loan. Servicing responsibilities shall include, but not necessarily be limited to, the following: (1) Loan disbursements as set forth in the loan agreement. (2) Collection of principal and interest payments on a monthly basis. (3) Maintenance of records on loan accounts. (4) Notification of the Secretary, without delay, as to the following: (i) That the initial disbursement or loan drawdown is ready to be made, together with evidence from the borrower that the bid or proposal preparation has begun or is about to begin. (ii) The date and amount of each subsequent disbursement under the loan. (iii) Any nonreceipt of payment within 10 days after the date specified for payment, together with evidence of appropriate notification to the borrower. (iv) Any known failure by the borrower to comply with the terms and conditions of the loan agreement. (v) Evidence, if any, that the borrower is likely to default on any condition set forth in the loan agreement or may be unable to make the next scheduled payment of principal or interest. (5) Submittal to DOE of periodic (semi-annual or annual) reports on the status and conditions of the loan and of the borrower." 10:10:5.0.2.5.23.4.16.2,10,Energy,III,,800,PART 800—LOANS FOR BID OR PROPOSAL PREPARATION BY MINORITY BUSINESS ENTERPRISES SEEKING DOE CONTRACTS AND ASSISTANCE,D,Subpart D—Loan Administration,,§ 800.301 Monitoring.,DOE,,,,"The Secretary shall have the right to audit any and all costs of the bid or proposal for which the loan is sought or made and to exclude or reduce the includible amount of any cost in accordance with § 800.200. Auditors who are employees of the United States Government, who are designated by the Secretary of Energy or by the Comptroller General of the United States, shall have access to, and the right to examine, any directly pertinent documents and records of an applicant or borrower at reasonable times under reasonable circumstances. The servicing agent, if any, shall make information regarding the loan available to the Secretary of Energy and Comptroller General to the extent lawful and within its ability. The Secretary may direct the applicant or borrower to submit to an audit by public accountant or equivalent acceptable to the Secretary." 10:10:5.0.2.5.23.4.16.3,10,Energy,III,,800,PART 800—LOANS FOR BID OR PROPOSAL PREPARATION BY MINORITY BUSINESS ENTERPRISES SEEKING DOE CONTRACTS AND ASSISTANCE,D,Subpart D—Loan Administration,,§ 800.302 Loan limitation.,DOE,,,,"The Secretary may limit the loan by written notice to the borrower to those amounts, if any, already disbursed under the loan, if the Secretary has determined that the borower has failed to comply with a material term or condition set forth in the loan agreement." 10:10:5.0.2.5.23.4.16.4,10,Energy,III,,800,PART 800—LOANS FOR BID OR PROPOSAL PREPARATION BY MINORITY BUSINESS ENTERPRISES SEEKING DOE CONTRACTS AND ASSISTANCE,D,Subpart D—Loan Administration,,§ 800.303 Assignment or transfer of loan.,DOE,,,,Assignment or transfer of the loan and obligations thereunder may be made only with the prior written consent of the Secretary. 10:10:5.0.2.5.23.4.16.5,10,Energy,III,,800,PART 800—LOANS FOR BID OR PROPOSAL PREPARATION BY MINORITY BUSINESS ENTERPRISES SEEKING DOE CONTRACTS AND ASSISTANCE,D,Subpart D—Loan Administration,,§ 800.304 Default.,DOE,,,,"(a) In the event that the borrower fails to perform the terms and conditions of the loan, the borrower shall be in default and the Secretary shall have the right, at the Secretary's option, to accelerate the indebtedness and demand full payment of all principal and interest amounts outstanding under the loan. (b) No failure on the part of the Secretary to make demand at any time shall constitute a waiver of the rights held by the Secretary. (c) Upon demand by the Secretary, the borrower shall have a period of not more than 30 days from the date of receipt of the Secretary's demand to make payment in full. (d) In the event that the failure on the part of the borrower to perform the terms and conditions of the loan does not constitute an intentional act, but is brought about as a result of circumstances largely beyond the control of the borrower, or is deemed by, the Secretary to be insubstantial, the Secretary may elect, at the Secretary's option, to defer such performance and/or restructure the repayment required by the loan agreement in any mutually acceptable manner. (e) Should the borrower fail to pay after demand as provided in paragraph (c) of this section, and no deferral or restructuring is agreed to by the Secretary as provided in paragraph (d) of this section, the Secretary shall undertake collection in accordance with the terms of the loan agreement and the applicable law." 10:10:5.0.2.5.23.4.16.6,10,Energy,III,,800,PART 800—LOANS FOR BID OR PROPOSAL PREPARATION BY MINORITY BUSINESS ENTERPRISES SEEKING DOE CONTRACTS AND ASSISTANCE,D,Subpart D—Loan Administration,,§ 800.305 Disclosure.,DOE,,,,"Information received from an applicant by DOE may be available to the public subject to the provision of 5 U.S.C. 552, 18 U.S.C. 1905 and 10 CFR part 1004; provided that: (a) Subject to the requirements of law, information such as trade secrets, commercial and financial information, and other information concerning the minority business enterprise that the enterprise submits to DOE in writing, in an application, or at other times throughout the duration of the loan on a privileged or confidential basis, will not be disclosed without prior notice to submitter in accordance with DOE regulations concerning public disclosure of information. Any submitter asserting that the information is privileged or confidential should appropriately identify and mark such information. (b) Upon a showing satisfactory to the Secretary that any information or portion thereof obtained under this regulation would, if made public, divulge trade secrets or other proprietary information of the minority business enterprise, the Secretary may not disclose such information. (c) This section shall not be construed as authority to withhold information from Congress or from any committee of Congress upon request of the Chairman." 10:10:5.0.2.5.23.4.16.7,10,Energy,III,,800,PART 800—LOANS FOR BID OR PROPOSAL PREPARATION BY MINORITY BUSINESS ENTERPRISES SEEKING DOE CONTRACTS AND ASSISTANCE,D,Subpart D—Loan Administration,,§ 800.306 Noninterference with other laws.,DOE,,,,"Nothing in this regulation shall be construed to modify requirements imposed on the borrower by Federal, State and local government agencies in connection with permits, licenses, or other authorizations to conduct or finance its business." 10:10:5.0.2.5.23.4.16.8,10,Energy,III,,800,PART 800—LOANS FOR BID OR PROPOSAL PREPARATION BY MINORITY BUSINESS ENTERPRISES SEEKING DOE CONTRACTS AND ASSISTANCE,D,Subpart D—Loan Administration,,§ 800.307 Appeals.,DOE,,,,"Any dispute concerning questions of fact arising under the loan agreement shall be decided in writing by the contracting officer. The borrower may request the contracting officer to reconsider any such decision, which reconsideration shall be promptly undertaken. If not satisfied with the contracting officer's final decision, the borrower, upon receipt of such written decision, may appeal the decision within 60 days in writing to the Chairman, Financial Assistance Appeals Board (FAAB), Department of Energy, Washington, DC 20585. The Board shall proceed in accordance with the Department of Energy's rules and regulations for such purpose. The decision of the Board with respect to such appeals shall be the final decision of the Secretary." 21:21:8.0.1.1.1.2.1.1,21,Food and Drugs,I,H,800,,B,Subpart B—Requirements for Specific Medical Devices,,§ 800.10 Contact lens solutions; sterility.,FDA,,,"[47 FR 50455, Nov. 5, 1982]","(a)(1) Informed medical opinion is in agreement that all preparations offered or intended for ophthalmic use, including contact lens solutions, should be sterile. It is further evident that such preparations purport to be of such purity and quality as to be suitable for safe use in the eye. (2) The Food and Drug Administration concludes that all such preparations, if they are not sterile, fall below their professed standard of purity or quality and may be unsafe. In a statement of policy issued on September 1, 1964, the Food and Drug Administration ruled that liquid preparations offered or intended for ophthalmic use that are not sterile may be regarded as adulterated within the meaning of section 501(c) of the Federal Food, Drug, and Cosmetic Act (the act), and, further, may be deemed misbranded within the meaning of section 502(j) of the act. By this regulation, this ruling is applicable to all preparations for ophthalmic use that are regulated as medical devices, i.e., contact lens solutions. By the regulation in § 200.50 of this chapter, this ruling is applicable to ophthalmic preparations that are regulated as drugs. (3) The containers shall be sterile at the time of filling and closing, and the container or individual carton shall be so sealed that the contents cannot be used without destroying the seal. The packaging and labeling of these solutions shall also comply with § 800.12 on tamper-resistant packaging requirements. (b) Liquid ophthalmic preparations packed in multiple-dose containers should: (1) Contain one or more suitable and harmless substances that will inhibit the growth of microorganisms; or (2) Be so packaged as to volume and type of container and so labeled as to duration of use and with such necessary warnings as to afford adequate protection and minimize the hazard of injury resulting from contamination during use. (c) Eye cups, eye droppers, and other dispensers intended for ophthalmic use should be sterile, and may be regarded as falling below their professed standard of purity or quality if they are not sterile. These articles, which are regulated as medical devices unless packaged with the drugs with which they are to be used, should be packaged so as to maintain sterility until the package is opened and be labeled, on or within the retail package, so as to afford adequate directions and necessary warnings to minimize the hazard of injury resulting from contamination during use." 21:21:8.0.1.1.1.2.1.2,21,Food and Drugs,I,H,800,,B,Subpart B—Requirements for Specific Medical Devices,,§ 800.12 Contact lens solutions and tablets; tamper-resistant packaging.,FDA,,,"[47 FR 50455, Nov. 5, 1982; 48 FR 1706, Jan. 14, 1983, as amended at 48 FR 16666, Apr. 19, 1983; 48 FR 37625, Aug. 19, 1983; 53 FR 11252, Apr. 6, 1988; 73 FR 34859, June 19, 2008]","(a) General. Unless contact lens solutions used, for example, to clean, disinfect, wet, lubricate, rinse, soak, or store contact lenses and salt tablets or other dosage forms to be used to make any such solutions are packaged in tamper-resistant retail packages, there is the opportunity for the malicious adulteration of these products with risks both to individuals who unknowingly purchase adulterated products and with loss of consumer confidence in the security of the packages of over-the-counter (OTC) health care products. The Food and Drug Administration has the authority and responsibility under the Federal Food, Drug, and Cosmetic Act (the act) to establish a uniform national standard for tamper-resistant packaging of those OTC products vulnerable to malicious adulteration that will improve the security of OTC packaging and help assure the safety and effectiveness of the products contained therein. A contact lens solution or tablet or other dosage form to be used to make such a solution for retail sale that is not packaged in a tamper-resistant package and labeled in accordance with this section is adulterated under section 501 of the act or misbranded under section 502 of the act, or both. (b) Requirement for tamper-resistant package. Each manufacturer and packer who packages for retail sale a product regulated as a medical device that is a solution intended for use with contact lenses, e.g., for cleaning, disinfecting, wetting, lubricating, rinsing, soaking, or storing contact lenses or tablets or other dosage forms to be used to make any such solution shall package the product in a tamper-resistant package, if this product is accessible to the public while held for sale. A tamper-resistant package is one having an indicator or barrier to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred. To reduce the likelihood of substitution of a tamper-resistant feature after tampering, the indicator or barrier to entry is required to be distinctive by design or by the use of an identifying characteristic (e.g., a pattern, name, registered trademark, logo, or picture). For purposes of this section, the term “distinctive by design” means the package cannot be duplicated with commonly available material or through commonly available processes. A tamper-resistant package may involve an immediate-container and closure system or secondary-container or carton system or any combination of systems intended to provide a visual indication of package integrity. The tamper-resistant feature shall be designed to and shall remain intact when handled in a reasonable manner during manufacture, distribution, and retail display. (c) Labeling. Each retail package of a product covered by this section is required to bear a statement that is prominently placed so that consumers are alerted to the tamper-resistant feature of the package. The labeling statement is also required to be so placed that it will be unaffected if the tamper-resistant feature of the package is breached or missing. If the tamper-resistant feature chosen to meet the requirement in paragraph (b) of this section is one that uses an identifying characteristic, that characteristic is required to be referred to in the labeling statement. For example, the labeling statement on a bottle with a shrink band could say “For your protection, this bottle has an imprinted seal around the neck.” (d) Requests for exemptions from packaging and labeling requirements. A manufacturer or packer may request an exemption from the packaging and labeling requirements of this section. A request for an exemption is required to be submitted in the form of a citizen petition under § 10.30 of this chapter and should be clearly identified on the envelope as a “Request for Exemption from Tamper-resistant Rule.” A petition for an exemption from a requirement of this section is required to contain the same kind of information about the product as is specified for OTC drugs in § 211.132(d) of this chapter. (e) Products subject to approved premarket approval applications. Holders of approved premarket approval applications for products subject to this section are required to submit supplements to provide for changes in packaging to comply with the requirement of paragraph (b) of this section unless these changes do not affect the composition of the container, the torque (tightness) of the container, or the composition of the closure component in contact with the contents (cap liner or innerseal) as these features are described in the approved premarket approval application. Any supplemental premarket approval application under this paragraph is required to include data sufficient to show that these changes do not adversely affect the product. (f) Effective date. Each product subject to this section is required to comply with the requirements of this section on the dates listed below except to the extent that a product's manufacturer or packer has obtained an exemption from a packaging or labeling requirement: (1) Initial effective date for packaging requirements. (i) The packaging requirement in paragraph (b) of this section is effective on February 7, 1983 for each contact lens solution packaged for retail sale on or after that date, except for the requirement in paragraph (b) of this section for a distinctive indicator or barrier to entry. (ii) The packaging requirement in paragraph (b) of this section is effective on May 5, 1983 for each tablet that is to be used to make a contact lens solution and that is packaged for retail sale on or after that date. (2) Initial effective date for labeling requirements. The requirement in paragraph (b) of this section that the indicator or barrier to entry be distinctive by design and the requirement in paragraph (c) of this section for a labeling statement are effective on May 5, 1983 for each product subject to this section packaged for retail sale on or after that date, except that the requirement for a specific label reference to any identifying characteristic is effective on February 6, 1984 for each affected product subject to this section packaged for retail sale on or after that date. (3) Retail level effective date. The tamper-resistant packaging requirement of paragraph (b) of this section is effective on February 6, 1984 for each product subject to this section that is held for sale at retail level on or after that date that was packaged for retail sale before May 5, 1983. This does not include the requirement in paragraph (b) of this section that the indicator or barrier to entry be distinctive by design. Products packaged for retail sale after May 5, 1983, are required to be in compliance with all aspects of the regulations without regard to the retail level effective date." 21:21:8.0.1.1.1.2.1.3,21,Food and Drugs,I,H,800,,B,Subpart B—Requirements for Specific Medical Devices,,§ 800.20 Patient examination gloves and surgeons' gloves; sample plans and test method for leakage defects; adulteration.,FDA,,,"[55 FR 51256, Dec. 12, 1990, as amended at 71 FR 75876, Dec. 19, 2006]","(a) Purpose. The prevalence of human immunodeficiency virus (HIV), which causes acquired immune deficiency syndrome (AIDS), and its risk of transmission in the health care context, have caused the Food and Drug Administration (FDA) to look more closely at the quality control of barrier devices, such as surgeons' gloves and patient examination gloves (collectively known as medical gloves) to reduce the risk of transmission of HIV and other blood-borne infectious diseases. The Centers for Disease Control (CDC) recommend that health care workers wear medical gloves to reduce the risk of transmission of HIV and other blood-borne infectious deseases. The CDC recommends that health care workers wear medical gloves when touching blood or other body fluids, mucous membranes, or nonintact skin of all patients; when handling items or surfaces soiled with blood or other body fluids; and when performing venipuncture and other vascular access procedures. Among other things, CDC's recommendation that health care providers wear medical gloves demonstrates the proposition that devices labeled as medical gloves purport to be and are represented to be effective barriers against the transmission of blood- and fluid-borne pathogens. Therefore, FDA, through this regulation, is defining adulteration for patient examination and surgeons' gloves as a means of assuring safe and effective devices. (1) For a description of a patient examination glove, see § 880.6250. Finger cots, however, are excluded from the test method and sample plans in paragraphs (b) and (c) of this section. (2) For a description of a surgeons' glove, see § 878.4460 of this chapter. (b)(1) General test method. For the purposes of this part, FDA's analysis of gloves for leaks and visual defects will be conducted by a visual examination and by a water leak test method, using 1,000 milliliters (ml) of water. (i) Units examined. Each medical glove will be analyzed independently. When packaged as pairs, each glove is considered separately, and both gloves will be analyzed. (ii) Identification of defects. For this test, defects include leaks detected when tested in accordance with paragraph (b)(3) of this section. A leak is defined as the appearance of water on the outside of the glove. This emergence of water from the glove constitutes a watertight barrier failure. Other defects include tears, embedded foreign objects, extrusions of glove material on the exterior or interior surface of the glove, gloves that are fused together so that individual glove separation is impossible, gloves that adhere to each other and tear when separated, or other visual defects that are likely to affect the barrier integrity. (iii) Factors for counting defects. One defect in one glove is counted as one defect. A defect in both gloves in a pair of gloves is counted as two defects. If multiple defects, as defined in paragraph (b)(1)(ii) of this section, are found in one glove, they are counted as one defect. Visual defects and leaks that are observed in the top 40 millimeters (mm) of a glove will not be counted as a defect for the purposes of this part. (2) Leak test materials. FDA considers the following to be the minimum materials required for this test : (i) A 60 mm by 380 mm (clear) plastic cylinder with a hook on one end and a mark scored 40 mm from the other end (a cylinder of another size may be used if it accommodates both cuff diameter and any water above the glove capacity); (ii) Elastic strapping with velcro or other fastening material; (iii) Automatic water-dispensing apparatus or manual device capable of delivering 1,000 ml of water; (iv) Stand with horizontal rod for hanging the hook end of the plastic tube. The horizontal support rod must be capable of holding the weight of the total number of gloves that will be suspended at any one time, e.g., five gloves suspended will weigh about 5 kilograms (kg); (v) Timer capable of measuring two minute intervals. (3) Visual defects and leak test procedures. Examine the sample and identify code/lot number, size, and brand as appropriate. Continue the visual examination using the following procedures: (i) Visual defects examination. Inspect the gloves for visual defects by carefully removing the glove from the wrapper, box, or package. Visually examine each glove for defects. As noted in paragraph (b)(1)(iii) of this section, a visual defect observed in the top 40 mm of a glove will not be counted as a defect for the purpose of this part. Visually defective gloves do not require further testing, although they must be included in the total number of defective gloves counted for the sample. (ii) Leak test set-up. (A) During this procedure, ensure that the exterior of the glove remains dry. Attach the glove to the plastic fill tube by bringing the cuff end to the 40 mm mark and fastening with elastic strapping to make a watertight seal. (B) Add 1,000 ml of room temperature water (i.e., 20 (deg)C to 30 (deg)C) into the open end of the fill tube. The water should pass freely into the glove. (With some larger sizes of long-cuffed surgeons' gloves, the water level may reach only the base of the thumb. With some smaller gloves, the water level may extend several inches up the fill tube.) (iii) Leak test examination. Immediately after adding the water, examine the glove for water leaks. Do not squeeze the glove; use only minimum manipulation to spread the fingers to check for leaks. Water drops may be blotted to confirm leaking. (A) If the glove does not leak immediately, keep the glove/filling tube assembly upright and hang the assembly vertically from the horizontal rod, using the wire hook on the open end of the fill tube (do not support the filled glove while transferring). (B) Make a second observation for leaks 2 minutes after the water is added to the glove. Use only minimum manipulation of the fingers to check for leaks. (C) Record the number of defective gloves. (c) Sampling, inspection, acceptance, and adulteration. In performing the test for leaks and other visual defects described in paragraph (b) of this section, FDA will collect and inspect samples of medical gloves, and determine when the gloves are acceptable as set out in paragraphs (c)(1) through (c)(3) of this section. (1) Sample plans. FDA will collect samples from lots of medical gloves in accordance with agency sampling plans. These plans are based on sample sizes, levels of sample inspection, and acceptable quality levels (AQLs) found in the International Standard Organization's standard ISO 2859, “Sampling Procedures For Inspection By Attributes.” (2) Sample sizes, inspection levels, and minimum AQLs. FDA will use single normal sampling for lots of 1,200 gloves or less and multiple normal sampling for all larger lots. FDA will use general inspection level II in determining the sample size for any lot size. As shown in the tables following paragraph (c)(3) of this section, FDA considers a 1.5 AQL to be the minimum level of quality acceptable for surgeons' gloves and a 2.5 AQL to be the minimum level of quality acceptable for patient examination gloves. (3) Adulteration levels and accept/reject criteria. FDA considers a lot of medical gloves to be adulterated when the number of defective gloves found in the tested sample meets or exceeds the applicable rejection number at the 1.5 AQL for surgeons' gloves or the 2.5 AQL for patient examination gloves. These acceptance and rejection numbers are identified in the tables following paragraph (c)(3) of this section as follows: Accept/Reject Criteria at 1.5 AQL for Surgeons' Gloves Accept/Reject Criteria at 2.5 AQL for Patient Examination Gloves (d) Compliance. Lots of gloves that are sampled, tested, and rejected using procedures in paragraphs (b) and (c) of this section, are considered adulterated within the meaning of section 501(c) of the act. (1) Detention and seizure. Lots of gloves that are adulterated under section 501(c) of the act are subject to administrative and judicial action, such as detention of imported products and seizure of domestic products. (2) Reconditioning. FDA may authorize the owner of the product, or the owner's representative, to attempt to recondition, i.e., bring into compliance with the act, a lot or part of a lot of foreign gloves detained at importation, or a lot or part of a lot of seized domestic gloves. (i) Modified sampling, inspection, and acceptance. If FDA authorizes reconditioning of a lot or portion of a lot of adulterated gloves, testing to confirm that the reconditioned gloves meet AQLs must be performed by an independent testing facility. The following tightened sampling plan must be followed, as described in ISO 2859 “Sampling Procedures for Inspection by Attributes:” (A) General inspection level II, (B) Single sampling plans for tightened inspection, (C) 1.5 AQL for surgeons' gloves, and (D) 2.5 AQL for patient examination gloves. (ii) Adulteration levels and acceptance criteria for reconditioned gloves. (A) FDA considers a lot or part of a lot of adulterated gloves, that is reconditioned in accordance with paragraph (d)(2)(i) of this section, to be acceptable when the number of defective gloves found in the tested sample does not exceed the acceptance number in the appropriate tables in paragraph (d)(2)(ii)(B) of this section for reconditioned surgeons' gloves or patient examination gloves. (B) FDA considers a reconditioned lot of medical gloves to be adulterated within the meaning of section 501(c) of the act when the number of defective gloves found in the tested sample meets or exceeds the applicable rejection number in the tables following paragraph (d)(2)(ii)(B) of this section: Accept/Reject Criteria at 1.5 AQL for Reconditioned Surgeons' Gloves Accept/Reject Criteria at 2.5 AQL for Reconditioned Patient Examination Gloves" 21:21:8.0.1.1.1.2.1.4,21,Food and Drugs,I,H,800,,B,Subpart B—Requirements for Specific Medical Devices,,§ 800.30 Over-the-counter hearing aid controls.,FDA,,,"[87 FR 50748, Aug. 17, 2022]","(a) Scope. This section specifies the requirements for over-the-counter (OTC) air-conduction hearing aids. Air-conduction hearing aids that satisfy the requirements in paragraphs (c) through (f) of this section are considered “available” over the counter as section 520(q)(1)(A)(v) of the Federal Food, Drug, and Cosmetic Act uses the term. Air-conduction hearing aids that do not meet the definition in section 520(q) of the Federal Food, Drug, and Cosmetic Act or do not satisfy the following requirements are prescription hearing aids. Unless otherwise specified, the requirements in this section are in addition to other applicable requirements, including but not limited to special controls found in the applicable classification regulation in part 874 of this chapter. (b) Definitions for the purposes of this section. This section uses the following definitions: Air-conduction hearing aid. An air-conduction hearing aid is a hearing aid that conducts sound to the ear through the air. Hearing aid. A hearing aid is any wearable device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing. Licensed person. A licensed person is a person as defined in section 201(e) of the Federal Food, Drug, and Cosmetic Act that holds a license or degree for the diagnosis, assessment, or treatment of hearing loss; or that holds a license to sell or distribute hearing aids. A person that must meet generally applicable licensing or operating requirements such as annual health and safety inspections, provided the generally applicable licensing or operating requirement is consistent with this section and other applicable requirements under the Federal Food, Drug, and Cosmetic Act, is not a “licensed person” solely for that reason. A person that represents as a marketer, seller, dispenser, distributor, or customer support representative (or an equivalent description) is not a “licensed person” solely by making such representations. Over-the-counter hearing aid. An over-the-counter (OTC) hearing aid is an air-conduction hearing aid that does not require implantation or other surgical intervention, and is intended for use by a person age 18 or older to compensate for perceived mild to moderate hearing impairment. The device, through tools, tests, or software, allows the user to control the hearing aid and customize it to the user's hearing needs. The device may use wireless technology or may include tests for self-assessment of hearing loss. The device is available over-the-counter, without the supervision, prescription, or other order, involvement, or intervention of a licensed person, to consumers through in-person transactions, by mail, or online, provided that the device satisfies the requirements in this section. Prescription hearing aid. A prescription hearing aid is a hearing aid that is not an OTC hearing aid as defined in this section or a hearing aid that does not satisfy the requirements in this section. Rebuilt hearing aid. An OTC hearing aid is “rebuilt” if the manufacturer has inspected and tested the device, made any necessary modifications to ensure it meets applicable regulatory requirements, including the requirements in this section to be available OTC, and adequately reprocessed the device for the next user. Sale. Sale includes a lease, rental, or any other purchase or exchange for value. Tools, tests, or software. Tools, tests, or software are components of the device that, individually or in combination, allow a lay user to control the device and customize it sufficiently, such as the device's output, to meet the user's hearing needs. Used hearing aid. A hearing aid is “used” if a user has worn it for any period of time. However, a hearing aid shall not be “used” merely because a prospective user wore it as part of a bona fide hearing aid evaluation to determine whether to select that particular hearing aid for that prospective user. A hearing aid evaluation is “bona fide” if it was conducted in the presence of the dispenser or a hearing health professional selected by the dispenser to assist the prospective user in making a determination. (c) Labeling. An OTC hearing aid shall bear all of the following in the labeling: (1) Outside package labeling. The outside package of an OTC hearing aid shall bear all of the following: (i) Warnings and other important information. All of the following shall appear on the outside package: (A) (A) Warning against use in people younger than 18. (B) Symptoms suggesting perceived mild to moderate hearing loss. (C) Advice of availability of professional services. (D) “Red flag” conditions. (E) Notice of contact information. (F) Notice of manufacturer's return policy. (ii) Statement of build condition. If the OTC hearing aid is used or rebuilt, the outside package shall declare that fact. A sticker under and visible through the outer wrapper will suffice to declare such fact. (iii) Statement of OTC availability. The principal display panel shall bear the marks “OTC” and “hearing aid” with the same prominence required under § 801.61(c) of this chapter for the device's statement of identity. The device's common name on the principal display panel may satisfy all or part of this requirement to the extent the common name includes the marks. (iv) Indication of battery information. The outside package shall indicate the type and number of batteries and whether batteries are included in the package. (v) Indication of control platform. The outside package shall indicate whether a mobile device or other non-included control platform is required. The indication must include the type of platform and how the platform connects to the device. (2) Labeling, inside the package. The manufacturer or distributor of an OTC hearing aid shall include a user instructional brochure inside the package and shall make an electronic version available for download without site or customer registration and without requiring purchase of any product or service. The user instructional brochure shall include all of the following: (i) The following warnings, which shall appear in the following order and prior to any content except the cover page: (A) Warning against use in people younger than 18. (B) “Red flag” conditions. (C) Warning about pain from device placement. (ii) Any additional warnings the manufacturer may include prior to the cautions and notices to users in paragraph (c)(2)(iii) of this section. (iii) The following cautions and notices for users, which shall appear prior to any content except the cover page and the warnings under paragraphs (c)(2)(i) and (ii) of this section: (A) Caution about hearing protection. (B) Caution about excessive sound output. (C) Caution about components lodging in ear. (D) Advice to seek professional services. (E) Note about user expectations. (E) Note about reporting adverse events to FDA. (iv) An illustration(s) of the OTC hearing aid that indicates operating controls, user adjustments, and the battery compartment. (v) Information on the function of all controls intended for user adjustment. (vi) A description of any accessory that accompanies the OTC hearing aid, including but not limited to wax guards and accessories for use with a computer, television, or telephone. (vii) Specific instructions for all of the following: (A) Instructions for sizing or inserting the eartip of the OTC hearing aid to prevent insertion past the depth limit and damage to the tympanic membrane. (B) The tools, tests, or software that allow the user to control the OTC hearing aid, including self-selection and self-checking the performance of the OTC hearing aid, and customize it to the user's hearing needs, including information about properly fitting eartips. (C) Use of the OTC hearing aid with any accompanying accessories. (D) Maintenance and care of the OTC hearing aid, including how a lay user can clean, disinfect, and replace parts or how to seek replacements, as well as how to store the hearing aid when it will not be used for an extended period of time. (E) If the battery is replaceable or rechargeable, how to replace or recharge the battery, including a generic designation of replacement batteries. (F) Expected battery life. (G) Any other information necessary for adequate directions for use as defined in § 801.5 of this chapter. (viii) Identification of any known physiological side effects associated with the use of the OTC hearing aid that may warrant consultation with a physician, referring to an ear-nose-throat doctor when preferable, including if applicable, skin irritation and accelerated accumulation of cerumen (ear wax). (ix) The technical specifications required by paragraph (c)(4) of this section. (x) A description of commonly occurring, avoidable events that could adversely affect or damage the OTC hearing aid, including but not limited to, as applicable, ear wax buildup, drops, immersion in water, or exposure to excessive heat. (xi) If the hearing aid incorporates wireless technology in its programming or use, appropriate warnings, instructions, and information relating to electromagnetic compatibility and wireless technology and human exposure to non-ionizing radiation. (xii) Information on how and where to obtain repair service or replacements, including at least one specific address where the user can go or send the OTC hearing aid to obtain such repair service or replacements. (xiii) If clinical or non-clinical studies were conducted by or for the manufacturer to support the performance of the OTC hearing aid, a summary of all such studies. (3) Labeling on the device. The labeling on an OTC hearing aid itself shall bear all of the following clearly and permanently, except as provided in paragraph (c)(3)(iii) of this section: (i) The serial number. (ii) If the battery is removable, a “+” symbol to indicate the positive terminal for battery insertion unless the battery's physical design prevents inserting the battery in the reversed position. (iii) If the OTC hearing aid is used or rebuilt, the manufacturer shall physically attach a removable tag to the hearing aid declaring that fact. (4) Technical specifications. All of the following technical specifications shall appear in the user instructional brochure that accompanies the device. You may additionally include it on the outside package: (i) The maximum output limit value (Output Sound Pressure Level 90 (OSPL90)). (ii) The full-on gain value, which is the gain with a 50 decibel (dB) Sound Pressure Level (SPL) pure-tone input and volume set to full on. (iii) The total harmonic distortion value. (iv) The self-generated noise value. (v) The latency value. (vi) The upper and lower cutoff frequencies for bandwidth. (5) Software device labeling. OTC hearing aid software that is not distributed with the hearing aid or amplification platform shall meet all of the following labeling requirements. With respect to the information required under paragraphs (c)(1) through (4) of this section, the information must be provided in the software device labeling, as specified in paragraphs (c)(5)(i) through (v) of this section, rather than the locations ( e.g., outside package labeling) specified in paragraphs (c)(1) through (4): (i) Prior to first use of the software or obtaining payment information for the software, whichever occurs first, the labeling must clearly and prominently present all of the following to the prospective user. For each, the labeling must remain visible until the user dismisses it or proceeds to the next step: (A) Compatibility and minimum operating requirements for the software device. (B) Disclosures of any fees or payments after first use or initial payment, including but not limited to any fees or payments relating to subscriptions, add-on features, or continued access to features or services. The disclosures must name and briefly describe what each fee or payment covers. (C) The information required under paragraphs (c)(1)(i), (iii), and (v) of this section. (ii) Prior to first use of the software, the labeling must clearly and prominently present all of the following to the prospective user: (A) The information required under paragraph (c)(2)(i)(A) of this section, and it must remain visible until the user acknowledges it. (B) The information required under paragraphs (c)(2)(i)(B) and (C), (c)(2)(ii), (iii), and (v), (c)(2)(vii)(B) and (G), and (c)(2)(viii) and (ix) of this section, and the information must remain visible until the user dismisses it or proceeds to the next step. (C) All other information required under paragraph (c)(2) of this section, to the extent applicable, and the information must remain visible until the user dismisses it or proceeds to the next step. (iii) The software device labeling must include the information required under paragraphs (c)(3)(i) and (c)(4) of this section. (iv) All of the software device labeling must be accessible for review after acknowledgment, dismissal, or proceeding to the next step. (v) If there are changes to any of the labeling required under paragraph (c)(5) of this section, the labeling with the changed information must be presented to the user until the user dismisses it. (d) Output limits. The output limit for an OTC hearing aid shall be the device maximum acoustic output sound pressure level (SPL) with an acoustic coupler as described in paragraph (e)(6) of this section when the device input is a 90 dB SPL pure-tone, and the gain/volume control is full on. An OTC hearing aid shall not exceed the following limits at any of the frequencies at which the device is intended to operate: (1) General output limit. An OTC hearing aid shall not exceed an output limit of 111 dB SPL at any frequency except as provided in paragraph (d)(2) of this section. (2) Output limit for a device with activated input-controlled compression. An OTC hearing aid that has input-controlled compression activated shall not exceed an output limit of 117 dB SPL at any frequency. (e) Electroacoustic performance limits. An OTC hearing aid shall perform within all of the following electroacoustic limits. Measure each electroacoustic performance characteristic using an acoustic coupler as described in paragraph (e)(6) of this section, where applicable: (1) Output distortion control limits. Test the output distortion of the OTC hearing aid as follows to ensure that it does not exceed the limit specified in paragraphs (e)(1)(i) through (iii) of this section. (i) The total harmonic distortion plus noise shall not exceed 5 percent for output levels within one of the following sets of levels, depending on the test method: (A) Using sine wave-based testing, measure at 70 dB SPL and 100 dB SPL; or (B) Using a 500-hertz (Hz) one-third-octave pulsed-noise signal, measure at 67 dB SPL and 97 dB SPL. (ii) You must measure the total harmonic distortion using a 500-Hz input tone with an analyzer that has a bandwidth at least as wide as the frequency limits of the OTC hearing aid. (iii) You must measure the output distortion at the OTC hearing aid's maximum volume and the input sound level to the OTC hearing aid adjusted to produce the required outputs. (2) Self-generated noise level limits. Self-generated noise shall not exceed 32 dBA. You must disable any methods that artificially lower the apparent noise floor for the measurement. Such methods would include but are not limited to auto-muting and downward expansion. (3) Latency. Latency shall not exceed 15 ms. You must measure the latency with a method that is accurate and repeatable to within 1.5 ms. (4) Frequency response bandwidth. The lower cutoff frequency shall extend to 250 Hz or below, and the upper cutoff frequency shall extend to 5 kHz or greater. You must measure the frequency response bandwidth as specified in the Method for clause 4.1 in ANSI/CTA-2051:2017. (5) Frequency response smoothness. No single peak in the one-third-octave frequency response shall exceed 12 dB relative to the average levels of the one-third-octave bands, two-thirds octave above and below the peak. You must measure the frequency response smoothness using values for a diffuse field and the corrected one-third-octave frequency insertion response as specified in the Method for clause 4.1 in ANSI/CTA-2051:2017. (6) Acoustic coupler choice. Where applicable, use one of the following acoustic couplers to measure electroacoustic performance: (i) When compatible with the device design, a 2-cubic centimeter (cm 3 ) acoustic coupler; or (ii) When a 2-cm 3 acoustic coupler is not compatible with the device design, an acoustic coupler that is a scientifically valid and technically equivalent alternative. You must document the rationale for using an alternative acoustic coupler. (f) Design requirements. An OTC hearing aid must conform to all of the following design requirements: (1) Insertion depth. The design of an OTC hearing aid shall limit the insertion of the most medial component so that, when inserted, the component is reasonably expected to remain at least 10 millimeters (mm) from the tympanic membrane. (2) Use of atraumatic materials. The material for the eartip of an OTC hearing aid shall be atraumatic. (3) Proper physical fit. The design of an OTC hearing aid shall enable consumers to readily achieve a safe, customized, acoustically favorable, and comfortable physical fit in the ear canal and/or external ear. (4) Tools, tests, or software. The OTC hearing aid shall, through tools, tests, or software, permit a lay user to control the device and customize it to the user's hearing needs. (5) User-adjustable volume control. The OTC hearing aid shall have a user-adjustable volume control. (6) Adequate reprocessing. If the OTC hearing aid is used or rebuilt, it must be adequately reprocessed for the next user prior to sale. (g) Conditions for sale of an OTC hearing aid. The sale of an OTC hearing aid is subject to all of the following conditions: (1) Age minimum. Sale to or for a person younger than 18 years of age is prohibited. (2) Statement of OTC availability. Sale of an OTC hearing aid is prohibited unless its labeling bears the statement of OTC availability required under paragraph (c)(1)(iii) of this section. (h) Effect on State law. Any State or local government requirement for an OTC hearing aid is preempted to the following extent: (1) Preemption. No State or local government shall establish or continue in effect any law, regulation, order, or other requirement specifically related to hearing products that would restrict or interfere with the servicing, marketing, sale, dispensing, use, customer support, or distribution of OTC hearing aids through in-person transactions, by mail, or online, that is different from, in addition to, or otherwise not identical to, the regulations promulgated under section 709(b) of the FDA Reauthorization Act of 2017, including any State or local requirement for the supervision, prescription, or other order, involvement, or intervention of a licensed person for consumers to access OTC hearing aids. (2) Professional requirements —(i) General rule. The servicing, marketing, sale, dispensing, customer support, or distribution of OTC hearing aids, or an equivalent activity, whether through in-person transactions, by mail, or online, shall not cause, require, or otherwise obligate a person providing such services to obtain specialized licensing, certification, or any other State or local sanction unless such requirement is generally applicable to the sale of any product or to all places of business regardless of whether they sell OTC hearing aids. However, although a State or local government may not require the order, involvement, or intervention of a licensed person for consumers to access OTC hearing aids, a licensed person may service, market, sell, dispense, provide customer support for, or distribute OTC hearing aids. (ii) Sale of OTC hearing aids is not an exemption. The servicing, marketing, sale, dispensing, customer support, or distribution of OTC hearing aids does not exempt a person from any State or local government's professional or establishment requirements that are consistent with this section. (iii) Representations may create professional obligations. A person shall not incur specialized obligations by representing as a servicer, marketer, seller, dispenser, customer support representative, or distributor (or an equivalent description) of OTC hearing aids. However, a person representing as any other defined professional or establishment, or as a State licensed dispenser, is subject to applicable State and local requirements even if the person undertakes commercial or professional activities only in relation to OTC hearing aids. (3) Private remedies. This section does not modify or otherwise affect the ability of any person to exercise a private right of action under any State or Federal product liability, tort, warranty, contract, or consumer protection law. (i) Incorporation by reference. ANSI/CTA-2051, “Personal Sound Amplification Performance Criteria,” dated January 2017 (ANSI/CTA-2051:2017), is incorporated by reference into this section with the approval of the Director of the Office of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. This material is available for inspection at the Food and Drug Administration and at the National Archives and Records Administration (NARA). Contact the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. For information on the availability of this material at NARA, email: fr.inspection@nara.gov, or go to: www.archives.gov/federal-register/cfr/ibr-locations.html. The material may be obtained from Consumer Technology Association (CTA), Technology & Standards Department, 1919 S Eads Street, Arlington, VA 22202; phone: 703-907-7600; fax: (703) 907-7693; email: standards@ce.org, website: www.cta.tech ." 21:21:8.0.1.1.1.3.1.1,21,Food and Drugs,I,H,800,,C,Subpart C—Administrative Practices and Procedures,,§ 800.55 Administrative detention.,FDA,,,"[44 FR 13239, Mar. 9, 1979, as amended at 49 FR 3174, Jan. 26, 1984; 69 FR 17292, Apr. 2, 2004; 79 FR 9412, Feb. 19, 2014; 82 FR 14147, Mar. 17, 2017; 85 FR 16555, Mar. 25, 2020]","(a) General. This section sets forth the procedures for detention of medical devices intended for human use believed to be adulterated or misbranded. Administrative detention is intended to protect the public by preventing distribution or use of devices encountered during inspections that may be adulterated or misbranded, until the Food and Drug Administration (FDA) has had time to consider what action it should take concerning the devices, and to initiate legal action, if appropriate. Devices that FDA orders detained may not be used, moved, altered, or tampered with in any manner by any person during the detention period, except as authorized under paragraph (h) of this section, until FDA terminates the detention order under paragraph (j) of this section, or the detention period expires, whichever occurs first. (b) Criteria for ordering detention. Administrative detention of devices may be ordered in accordance with this section when an authorized FDA representative, during an inspection under section 704 of the Federal Food, Drug, and Cosmetic Act (the act), has reason to believe that a device, as defined in section 201(h) of the act, is adulterated or misbranded. (c) Detention period. The detention is to be for a reasonable period that may not exceed 20 calendar days after the detention order is issued, unless the FDA Division Director in whose division the devices are located determines that a greater period is required to seize the devices, to institute injunction proceedings, or to evaluate the need for legal action, in which case the Division Director may authorize detention for 10 additional calendar days. The additional 10-calendar-day detention period may be ordered at the time the detention order is issued or at any time thereafter. The entire detention period may not exceed 30 calendar days, except when the detention period is extended under paragraph (g)(6) of this section. An authorized FDA representative may, in accordance with paragraph (j) of this section, terminate a detention before the expiration of the detention period. (d) Issuance of detention order. (1) The detention order shall be issued in writing, in the form of a detention notice, signed by the authorized FDA representative who has reason to believe that the devices are adulterated or misbranded, and issued to the owner, operator, or agent in charge of the place where the devices are located. If the owner or the user of the devices is different from the owner, operator, or agent in charge of the place where the devices are detained, a copy of the detention order shall be provided to the owner or user of the devices if the owner's or user's identity can be readily determined. (2) If detention of devices in a vehicle or other carrier is ordered, a copy of the detention order shall be provided to the shipper of record and the owner of the vehicle or other carrier, if their identities can be readily determined. (3) The detention order shall include the following information: (i) A statement that the devices identified in the order are detained for the period shown; (ii) A brief, general statement of the reasons for the detention; (iii) The location of the devices; (iv) A statement that these devices are not to be used, moved, altered, or tampered with in any manner during that period, except as permitted under paragraph (h) of this section, without the written permission of an authorized FDA representative; (v) Identification of the detained devices; (vi) The detention order number; (vii) The date and hour of the detention order; (viii) The period of the detention; (ix) The text of section 304(g) of the act and paragraph (g) (1) and (2) of this section; (x) A statement that any informal hearing on an appeal of a detention order shall be conducted as a regulatory hearing under part 16 of this chapter, with certain exceptions described in paragraph (g)(3) of this section; and (xi) The mailing address, telephone number, and name of the FDA Division Director. (e) Approval of detention order. A detention order, before issuance, shall be approved by the FDA Division Director in whose division the devices are located. If prior written approval is not feasible, prior oral approval shall be obtained and confirmed by written memorandum within FDA as soon as possible. (f) Labeling or marking a detained device. An FDA representative issuing a detention order under paragraph (d) of this section shall label or mark the devices with official FDA tags that include the following information: (1) A statement that the devices are detained by the United States Government in accordance with section 304(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 334(g)). (2) A statement that the devices shall not be used, moved, altered, or tampered with in any manner for the period shown, without the written permission of an authorized FDA representative, except as authorized in paragraph (h) of this section. (3) A statement that the violation of a detention order or the removal or alteration of the tag is punishable by fine or imprisonment or both (section 303 of the act, 21 U.S.C. 333). (4) The detention order number, the date and hour of the detention order, the detention period, and the name of the FDA representative who issued the detention order. (g) Appeal of a detention order. (1) A person who would be entitled to claim the devices, if seized, may appeal a detention order. Any appeal shall be submitted in writing to the FDA Division Director in whose division the devices are located within 5 working days of receipt of a detention order. If the appeal includes a request for an informal hearing, as defined in section 201(x) of the act, the appellant shall request either that a hearing be held within 5 working days after the appeal is filed or that the hearing be held at a later date, which shall not be later than 20 calendar days after receipt of a detention order. (2) The appellant of a detention order shall state the ownership or proprietary interest the appellant has in the detained devices. If the detained devices are located at a place other than an establishment owned or operated by the appellant, the appellant shall include documents showing that the appellant would have legitimate authority to claim the devices if seized. (3) Any informal hearing on an appeal of a detention order shall be conducted as a regulatory hearing pursuant to regulation in accordance with part 16 of this chapter, except that: (i) The detention order under paragraph (d) of this section, rather than the notice under § 16.22(a) of this chapter, provides notice of opportunity for a hearing under this section and is part of the administrative record of the regulatory hearing under § 16.80(a) of this chapter. (ii) A request for a hearing under this section should be addressed to the FDA Division Director. (iii) The last sentence of § 16.24(e) of this chapter, stating that a hearing may not be required to be held at a time less than 2 working days after receipt of the request for a hearing, does not apply to a hearing under this section. (iv) Paragraph (g)(4) of this section, rather than § 16.42(a) of this chapter, describes the FDA employees who preside at hearings under this section. (4) The presiding officer of a regulatory hearing on an appeal of a detention order, who also shall decide the appeal, shall be an Office of Regulatory Affairs Program Director or another FDA official senior to an FDA Division Director who is permitted by § 16.42(a) of this chapter to preside over the hearing. (5) If the appellant requests a regulatory hearing and requests that the hearing be held within 5 working days after the appeal is filed, the presiding officer shall, within 5 working days, hold the hearing and render a decision affirming or revoking the detention. (6) If the appellant requests a regulatory hearing and requests that the hearing be held at a date later than within 5 working days after the appeal is filed, but not later than 20 calendar days after receipt of a detention order, the presiding officer shall hold the hearing at a date agreed upon by FDA and the appellant. The presiding officer shall decide whether to affirm or revoke the detention within 5 working days after the conclusion of the hearing. The detention period extends to the date of the decision even if the 5-working-day period for making the decision extends beyond the otherwise applicable 20-calendar-day or 30-calendar-day detention period. (7) If the appellant appeals the detention order but does not request a regulatory hearing, the presiding officer shall render a decision on the appeal affirming or revoking the detention within 5 working days after the filing of the appeal. (8) If the presiding officer affirms a detention order, the devices continue to be detained until FDA terminates the detention under paragraph (j) of this section or the detention period expires, whichever occurs first. (9) If the presiding officer revokes a detention order, FDA shall terminate the detention under paragraph (j) of this section. (h) Movement of detained devices. (1) Except as provided in this paragraph (h), no person shall move detained devices within or from the place where they have been ordered detained until FDA terminates the detention under paragraph (j) of this section or the detention period expires, whichever occurs first. (2) If detained devices are not in final form for shipment, the manufacturer may move them within the establishment where they are detained to complete the work needed to put them in final form. As soon as the devices are moved for the purpose of the preceding sentence, the individual responsible for their movement shall orally notify the FDA representative who issued the detention order, or another responsible division office official, of the movement of the devices. As soon as the devices are put in final form, they shall be segregated from other devices, and the individual responsible for their movement shall orally notify the FDA representative who issued the detention order, or another responsible division office official, of their new location. The devices put in final form shall not be moved further without FDA approval. (3) The FDA representative who issued the detention order, or another responsible division office official, may approve, in writing, the movement of detained devices for any of the following purposes: (i) To prevent interference with an establishment's operations or harm to the devices. (ii) To destroy the devices. (iii) To bring the devices into compliance. (iv) For any other purpose that the FDA representative who issued the detention order, or other responsible division office official, believes is appropriate in the case. (4) If an FDA representative approves the movement of detained devices under paragraph (h)(3) of this section, the detained devices shall remain segregated from other devices and the person responsible for their movement shall immediately orally notify the official who approved the movement of the devices, or another responsible FDA division office official, of the new location of the detained devices. (5) Unless otherwise permitted by the FDA representative who is notified of, or who approves, the movement of devices under this paragraph, the required tags shall accompany the devices during and after movement and shall remain with the devices until FDA terminates the detention or the detention period expires, whichever occurs first. (i) Actions involving adulterated or misbranded devices. If FDA determines that the detained devices, including any that have been put in final form, are adulterated or misbranded, or both, it may initiate legal action against the devices or the responsible individuals, or both, or request that the devices be destroyed or otherwise brought into compliance with the act under FDA's supervision. (j) Detention termination. If FDA decides to terminate a detention or when the detention period expires, whichever occurs first, an FDA representative authorized to terminate a detention will issue a detention termination notice releasing the devices to any person who received the original detention order or that person's representative and will remove, or authorize in writing the removal of, the required labels or tags. (k) Recordkeeping requirements. (1) After issuance of a detention order under paragraph (d) of this section, the owner, operator, or agent in charge of any factory, warehouse, other establishment, or consulting laboratory where detained devices are manufactured, processed, packed, or held shall have, or establish, and maintain adequate records relating to how the detained devices may have become adulterated or misbranded, records on any distribution of the devices before and after the detention period, records on the correlation of any in-process detained devices that are put in final form under paragraph (h) of this section to the completed devices, records of any changes in, or processing of, the devices permitted under the detention order, and records of any other movement under paragraph (h) of this section. Records required under this paragraph shall be provided to the FDA on request for review and copying. Any FDA request for access to records required under this paragraph shall be made at a reasonable time, shall state the reason or purpose for the request, and shall identify to the fullest extent practicable the information or type of information sought in the records to which access is requested. (2) Records required under this paragraph shall be maintained for a maximum period of 2 years after the issuance of the detention order or for such other shorter period as FDA directs. When FDA terminates the detention or when the detention period expires, whichever occurs first, FDA will advise all persons required under this paragraph to keep records concerning that detention whether further recordkeeping is required for the remainder of the 2-year, or shorter, period. FDA ordinarily will not require further recordkeeping if the agency determines that the devices are not adulterated or misbranded or that recordkeeping is not necessary to protect the public health, unless the records are required under other regulations in this chapter (e.g., the good manufacturing practice regulation in part 820 of this chapter)." 21:21:8.0.1.1.1.3.1.2,21,Food and Drugs,I,H,800,,C,Subpart C—Administrative Practices and Procedures,,§ 800.75 Requests for supervisory review of certain decisions made by the Center for Devices and Radiological Health.,FDA,,,"[84 FR 31477, July 2, 2019]","(a) Definitions. The following definitions shall apply to this section: (1) FDA means the Food and Drug Administration. (2) 517A decision means a significant decision made by the Center for Devices and Radiological Health, as set forth in section 517A of the Federal Food, Drug, and Cosmetic Act, and includes one of the following decisions: (i) A substantially equivalent order under § 807.100(a)(1) of this chapter, or a not substantially equivalent order under § 807.100(a)(2) of this chapter; (ii) An approval order under § 814.44(d) of this chapter, an approvable letter under § 814.44(e) of this chapter, a not approvable letter under § 814.44(f) of this chapter, or an order denying approval under § 814.45 of this chapter; (iii) An approval order under § 814.116(b) of this chapter, an approvable letter under § 814.116(c) of this chapter, a not approvable letter under § 814.116(d) of this chapter, or an order denying approval under § 814.118 of this chapter; (iv) A grant or denial of a request for breakthrough device designation under section 515B of the Federal Food, Drug, and Cosmetic Act; (v) An approval order under § 812.30(a) of this chapter or a disapproval order under § 812.30(c) of this chapter; (vi) A failure to reach agreement letter under section 520(g)(7) of the Federal Food, Drug, and Cosmetic Act; or (vii) A clinical hold determination under section 520(g)(8) of the Federal Food, Drug, and Cosmetic Act. (3) CDRH means the Center for Devices and Radiological Health. (b) Submission of request —(1) Review of 517A decisions . (i) An initial or sequential request for supervisory review within CDRH of a 517A decision under § 10.75 of this chapter must be addressed to the next organizational level or higher above the individual who made the decision; submitted in electronic format in accordance with section 745A(b) of the Federal Food, Drug, and Cosmetic Act; marked “Appeal: Request for Supervisory Review”; and received by CDRH no later than 30 days after the date of the decision involved. Any such request for supervisory review not received by CDRH within 30 days after the date of the decision involved is not eligible for review. Except as provided in paragraph (b)(1)(ii) or (iii) of this section, FDA will render a decision within 45 days of the request for supervisory review. (ii) A person requesting supervisory review under paragraph (b)(1)(i) may request an in-person meeting or teleconference with the supervisor reviewing the request for supervisory review. Except as provided in paragraph (b)(1)(iii) of this section, if a request for in-person meeting or teleconference is included in the request for supervisory review to CDRH, CDRH will schedule the meeting or teleconference to occur within 30 days of receipt of the request. Except as provided in paragraph (b)(1)(iii) of this section, a decision will be rendered within 30 days of such meeting or teleconference. (iii) The timeframes for CDRH to render a decision provided in (b)(1)(i) and (ii) of this section, and the timeframe to schedule an in-person meeting or teleconference review in (b)(1)(ii) of this section, do not apply if a matter related to the 517A decision under review is referred by CDRH to external experts, such as an advisory committee, as provided in § 10.75(b) of this chapter. (2) Supervisory review. An initial or sequential request for supervisory review within CDRH under § 10.75 of this chapter of a decision other than a 517A decision that is not received by CDRH within 60 days after the date of the decision involved will be denied as untimely, unless CDRH, for good cause, permits the request to be filed after 60 days. An initial or sequential request for supervisory review within CDRH of a decision other than a 517A decision must be addressed to the next organizational level or higher above the individual who made the decision; submitted in electronic format in accordance with section 745A(b) of the Federal Food, Drug, and Cosmetic Act, when applicable; marked, “Appeal: Request for Supervisory Review” in the subject line of the electronic request; and sent to the CDRH Ombudsman at CDRHOmbudsman@fda.hhs.gov ." 28:28:2.0.6.5.1.0.127.1,28,Judicial Administration,VIII,,800,PART 800—ORGANIZATION AND FUNCTIONS,,,,§ 800.1 Statutory authorization.,CSOSA,,,,"The National Capital Revitalization and Self-Government Improvement Act of 1997 (“Revitalization Act”) established the Court Services and Offender Supervision Agency for the District of Columbia (“CSOSA”) within the federal government as an independent executive branch agency and placed the District of Columbia Pretrial Services Agency as an independent entity within CSOSA. In addition, the District of Columbia Public Defender Service, an independent District of Columbia agency, receives its appropriated federal funds through a transfer from CSOSA." 28:28:2.0.6.5.1.0.127.2,28,Judicial Administration,VIII,,800,PART 800—ORGANIZATION AND FUNCTIONS,,,,§ 800.2 Mission.,CSOSA,,,,"CSOSA's mission is to increase public safety, prevent crime, reduce recidivism, and support the fair administration of justice in close collaboration with the community." 28:28:2.0.6.5.1.0.127.3,28,Judicial Administration,VIII,,800,PART 800—ORGANIZATION AND FUNCTIONS,,,,§ 800.3 Functions and responsibilities.,CSOSA,,,,"(a) Community Supervision Services. (1) The Revitalization Act requires CSOSA to provide supervision, through qualified supervision officers, to offenders on probation, parole, and supervised release for violation of District of Columbia Code offenses. The Agency carries out its responsibilities on behalf of the court or agency having jurisdiction over the person being supervised. Accordingly, CSOSA supervises all offenders placed on probation by the Superior Court of the District of Columbia, and all individuals on parole pursuant to the District of Columbia Code. CSOSA supervises offenders from other jurisdictions in accordance with the provisions of the Interstate Parole and Probation Compact. (2) CSOSA is also required to determine uniform supervision and reporting practices, develop and operate intermediate sanctions programs for sentenced offenders, and arrange for the supervision of District of Columbia Code offenders in jurisdictions outside the District of Columbia. (3) In accordance with its supervisory functions and as authorized by the Sex Offender Registration Act of 1999 (D.C. Law 13-137, D.C. Code 24-1101 et seq. ), CSOSA operates and maintains the sex offender registry for the District of Columbia. (b) Pretrial Services. (1) The District of Columbia Pretrial Services Agency (“PSA”) assists the trial and appellate levels of both the federal and local courts in determining eligibility for pretrial release by providing verified background information and criminal histories on all arrestees and recommendations about available release options. (2) PSA is further responsible for supervising defendants released from custody during the pretrial period by monitoring compliance with conditions of release and by ensuring that they appear for scheduled court hearings. (3) PSA also provides defendants with the opportunity to participate in a variety of social intervention programs that decrease the likelihood of future criminal behavior." 28:28:2.0.6.5.1.0.127.4,28,Judicial Administration,VIII,,800,PART 800—ORGANIZATION AND FUNCTIONS,,,,§ 800.4 Director.,CSOSA,,,,"(a) CSOSA is headed by a Director appointed by the President, by and with the advice and consent of the Senate, for a term of six years. (b) PSA is headed by a Director appointed by the Chief Judge of the United States Court of Appeals for the District of Columbia Circuit and the Chief Judge of the United States District Court for the District of Columbia in consultation with an Executive Committee. The Executive Committee includes the four chief judges of the local and Federal trial and appellate courts, the United States Attorney for the District of Columbia, the Director of the District of Columbia Public Defender Service, and the Director of CSOSA." 28:28:2.0.6.5.1.0.127.5,28,Judicial Administration,VIII,,800,PART 800—ORGANIZATION AND FUNCTIONS,,,,§ 800.5 Agency components.,CSOSA,,,,"(a) CSOSA. (1) Office of the Director (including the Deputy Director). (2) Office of the General Counsel. (3) Community Supervision Services. (4) Office of Community Justice Programs. (5) Special Criminal Justice Projects. (6) Office of Planning and Evaluation. (7) Office of Professional Responsibility. (8) Equal Employment Opportunity, Diversity, and Special Programs. (9) Office of Legislative, Intergovernmental, and Public Affairs. (10) Information Technology Services. (11) Office of Management and Administration. (12) Office of Human Resources. (b) PSA. (1) Office of the Director (including the Deputy Director). (2) Planning, Analysis and Evaluation. (3) Community Justice Programs. (4) Office of Operations (including Information Technology and Forensic Toxicology and Drug Testing Laboratory). (5) Human Resources Management. (6) Finance and Administration." 49:49:7.1.4.1.1.1.1.1,49,Transportation,VIII,,800,PART 800—ADMINISTRATIVE RULES,A,Subpart A—Organization and Functions,,§ 800.1 Purpose.,NTSB,,,"[49 FR 26232, June 27, 1984, as amended at 81 FR 75730, Nov. 1, 2016]","This subpart describes the organization, functions, and operation of the National Transportation Safety Board (Board)." 49:49:7.1.4.1.1.1.1.2,49,Transportation,VIII,,800,PART 800—ADMINISTRATIVE RULES,A,Subpart A—Organization and Functions,,§ 800.2 Organization.,NTSB,,,"[60 FR 61488, Nov. 30, 1996, as amended at 61 FR 14521, Apr. 2, 1995; 63 FR 71605, Dec. 29, 1998; 64 FR 5621, Feb. 4, 1999; 81 FR 75730, Nov. 1, 2016]","The Board consists of five Members appointed by the President with the advice and consent of the Senate. One of the Members is designated by the President as Chairman with the advice and consent of the Senate and one as Vice Chairman. The Members exercise various functions, powers, and duties set forth in 49 U.S.C. chapter 11. The Board is an independent agency of the United States. More detailed descriptions of the Board and its work are contained in other parts of this chapter VIII, notably parts 825, 830 through 835, and 840 through 850. Various special delegations of authority from the Board and the Chairman to the staff are set forth in subpart B of this part. The Board's staff is comprised of the following principal components: (a) The Office of the Managing Director, which assists the Chairman in the discharge of his functions as executive and administrative head of the Board; coordinates and directs the activities of the staff; is responsible for the day-to-day operation of the Board; and recommends and develops plans to achieve the Board's program objectives. The Office of the Managing Director also provides executive secretariat services to the Board. (b) The Office of Government, Public, and Family Affairs, which supplies the Congress and Federal, State, and local government agencies with information regarding the Safety Board's activities, programs and objectives; supplies the public, the transportation industry and the news media with current, accurate information concerning the work, programs, and objectives of the Board; coordinates public and private responsibilities, including aid to survivors and families of accident victims, in the wake of transportation disasters. This Office maintains the 24-hour Communications Center, which assists in coordinating accident notification and launch operations for all modes and provides an off-hour base for family assistance functions during accident investigations. (c) The Office of the General Counsel, which provides legal advice and assistance to the Board and its staff; prepares Board rules, opinions and/or orders, and advice to all offices on matters of legal significance; and represents the Board in judicial matters to which the Board is a party or in which the Board is interested. (d) The Office of Administrative Law Judges, which conducts all formal proceedings arising under 49 U.S.C. 1133, including proceedings involving civil penalties and suspension or revocation of certificates, and appeals from actions of the Federal Aviation Administrator in refusing to issue airman certificates. (e) The Office of Aviation Safety, which conducts investigations of all aviation accidents within the Board's jurisdiction; prepares reports for submission to the Board and release to the public setting forth the facts and circumstances of such accidents, including a recommendation as to the probable cause(s); determines the probable cause(s) of accidents when delegated authority to do so by the Board; initiates safety recommendations to prevent future aviation accidents; participates in the investigation of accidents that occur in foreign countries and involve U.S.-registered and/or U.S.-manufactured aircraft; and conducts special investigations into selected aviation accidents involving safety issues of concern to the Board. (f) The Office of Railroad Safety, which conducts investigations of railroad accidents within the Board's jurisdiction; prepares reports for submission to the Board and release to the public setting forth the facts and circumstances of such accidents, including a recommendation as to the probable cause(s); determines the probable cause(s) of accidents when delegated authority to do so by the Board; initiates safety recommendations to prevent future railroad accidents; and conducts special investigations into selected rail accidents involving safety issues of concern to the Board. (g) The Office of Highway Safety, which conducts investigations of highway accidents, including railroad grade-crossing accidents, within the Board's jurisdiction; prepares reports for submission to the Board and release to the public setting forth the facts and circumstances of such accidents, including a recommendation as to the probable cause(s); determines the probable cause(s) of accidents when delegated authority to do so by the Board; initiates safety recommendations to prevent future highway accidents; and conducts special investigations into selected highway accidents involving safety issues of concern to the Board. (h) The Office of Marine Safety, which conducts investigations of marine accidents within the Board's jurisdiction; prepares reports for submission to the Board and release to the public setting forth the facts and circumstances of such accidents, including a recommendation as to the probable cause(s); determines the probable cause(s) of accidents when delegated authority to do so by the Board; initiates safety recommendations to prevent future marine accidents; participates in the investigation of accidents that occur in foreign countries and that involve U.S.-registered vessels; and conducts special investigations into selected marine accidents involving safety issues of concern to the Board. (i) The Office of Pipeline and Hazardous Materials Safety, which conducts investigations of pipeline and hazardous materials accidents within the Board's jurisdiction; prepares reports for submission to the Board and release to the public setting forth the facts and circumstances of such accidents, including a recommendation as to the probable cause(s); determines the probable causes of accidents when delegated authority to do so by the Board; initiates safety recommendations to prevent future pipeline and hazardous materials accidents; and conducts special investigations into selected pipeline and hazardous materials accidents involving safety issues of concern to the Board. (j) The Office of Research and Engineering, which conducts research and carries out analytical studies and tests involving all modes, including readouts of voice and data recorders, flight path analysis and computer simulation/animation, component examination and material failure analysis; conducts safety studies of specific safety issues; performs statistical analyses of transportation accident and incident data; maintains archival records of the Board's accident investigation and safety promotion activities and supports public access to these records; and administers the Board's information technology infrastructure, including computer systems, networks, databases, and application software. (k) The Office of Safety Recommendations & Accomplishments, which oversees the Board's safety recommendations program, including the Board's “MOST WANTED” recommendations, and the Board's safety accomplishment program." 49:49:7.1.4.1.1.1.1.3,49,Transportation,VIII,,800,PART 800—ADMINISTRATIVE RULES,A,Subpart A—Organization and Functions,,§ 800.3 Functions.,NTSB,,,"[81 FR 75730, Nov. 1, 2016]","(a) The primary function of the Board is to promote safety in transportation. The Board is responsible for the investigation, determination of facts, conditions, and circumstances and the cause or probable cause or causes of: (1) All accidents involving civil aircraft, and certain public aircraft; (2) Highway accidents, including railroad grade-crossing accidents, the investigation of which is selected in cooperation with the States; (3) Railroad accidents in which there is a fatality, substantial property damage, or which involve a passenger train; (4) Pipeline accidents in which there is a fatality, significant injury to the environment, or substantial property damage; and (5) Major marine casualties and marine accidents involving a public and a non-public vessel or involving Coast Guard functions. (b) The Board makes transportation safety recommendations to federal, state, and local agencies and private organizations to reduce the likelihood of transportation accidents. It initiates and conducts safety studies and special investigations on matters pertaining to safety in transportation, assesses techniques and methods of accident investigation, evaluates the effectiveness of transportation safety consciousness and efficacy of other Government agencies, and evaluates the adequacy of safeguards and procedures concerning the transportation of hazardous materials. (c) Upon application of affected parties, the Board reviews in quasijudicial proceedings, conducted pursuant to the Administrative Procedure Act, 5 U.S.C. 551 et seq., denials by the Administrator of the Federal Aviation Administration of applications for airman certificates and orders of the Administrator modifying, amending, suspending, or revoking certificates or imposing civil penalties. The Board also reviews on appeal the decisions of the head of the agency in which the U.S. Coast Guard is operating, on appeals from orders of administrative law judges suspending, revoking, or denying seamen licenses, certificates, or documents. (d) The Board, as provided in part 801 of this chapter, issues reports and orders pursuant to its duties to determine the cause or probable cause or causes of transportation accidents and to report the facts, conditions and circumstances relating to such accidents; issues opinions and/or orders in accordance with 49 U.S.C. 1133 after reviewing on appeal the imposition of a civil penalty or the suspension, amendment, modification, revocation, or denial of a certificate or license issued by the Secretary of the Department of Transportation (who acts through the Administrator of the Federal Aviation Administration) or by the Commandant of the United States Coast Guard; and issues and makes available to the public safety recommendations, safety studies, and reports of special investigations." 49:49:7.1.4.1.1.1.1.4,49,Transportation,VIII,,800,PART 800—ADMINISTRATIVE RULES,A,Subpart A—Organization and Functions,,§ 800.4 Operation.,NTSB,,,"[49 FR 26232, June 27, 1984, as amended at 60 FR 61489, Nov. 30, 1995; 81 FR 75730, Nov. 1, 2016]","In exercising its functions, duties, and responsibilities, the Board utilizes: (a) The Board's staff, consisting of specialized offices dealing with particular areas of transportation safety and performing administrative and technical work for the Board. The staff advises the Board and performs duties for the Board that are inherent in the staff's position in the organizational structure or that the Board has delegated to it. The staff is described more fully in § 800.2. (b) Rules published in the Federal Register and codified in this Title 49 of the Code of Federal Regulations. These rules may be inspected in the Board's public reference room, or purchased from the Superintendent of Documents, Government Publishing Office. (c) Procedures and policies set forth in the agency's internal directives system which govern the activities of employees and organizational components of the Board. The internal directives system is designated as the NTSB Manual and consists of instructions which are called NTSB Orders and NTSB Notices. (d) Meetings of the Board Members conducted pursuant to the Government in the Sunshine Act. (e) Public hearings in connection with transportation accident investigations and public hearings and oral arguments in proceedings concerned with certificates or licenses issued by the Secretary or an Administrator of the Department of Transportation or the Commandant of the United States Coast Guard. They are held at the time and place announced in the notices thereof which are served on the parties to the proceedings or published in the Federal Register." 49:49:7.1.4.1.1.1.1.5,49,Transportation,VIII,,800,PART 800—ADMINISTRATIVE RULES,A,Subpart A—Organization and Functions,,§ 800.5 Office locations.,NTSB,,,"[60 FR 61489, Nov. 30, 1995, as amended at 81 FR 75731, Nov. 1, 2016]","The principal offices of the National Transportation Safety Board are located at 490 L'Enfant Plaza East, SW., Washington, DC 20594-003. The Board maintains field offices in selected cities throughout the United States." 49:49:7.1.4.1.1.1.1.6,49,Transportation,VIII,,800,PART 800—ADMINISTRATIVE RULES,A,Subpart A—Organization and Functions,,§ 800.6 Availability of information and materials.,NTSB,,,,Part 801 of this chapter provides detailed information concerning the availability of Board documents and records. That part also provides a fee schedule and information concerning inspection and copying. 49:49:7.1.4.1.1.2.1.1,49,Transportation,VIII,,800,PART 800—ADMINISTRATIVE RULES,B,Subpart B—Delegations of Authority to Staff Members,,§ 800.21 Purpose.,NTSB,,,"[60 FR 61489, Nov. 30, 1995, as amended at 81 FR 75731, Nov. 1, 2016]",The purpose of this subpart is to publish special delegations of authority to staff members. 49:49:7.1.4.1.1.2.1.2,49,Transportation,VIII,,800,PART 800—ADMINISTRATIVE RULES,B,Subpart B—Delegations of Authority to Staff Members,,§ 800.22 Delegation to the Managing Director.,NTSB,,,"[60 FR 61489, Nov. 30, 1995, as amended at 81 FR 75731, Nov. 1, 2016]","(a) The Board delegates to the Managing Director the authority to: (1) Make the final determination, on appeal, as to whether to withhold a Board record from inspection or copying, pursuant to Part 801 of this chapter. (2) Approve for publication in the Federal Register notices concerning issuance of accident reports and safety recommendations and responses to safety recommendations, as required by 49 U.S.C. 1131(e), 1135(c). (b) The Chairman delegates to the Managing Director the authority to exercise and carry out, subject to the direction and supervision of the Chairman, the following functions vested in the Chairman: (1) The appointment and supervision of personnel employed by the Board; (2) The distribution of business among such personnel and among organizational components of the Board; and (3) The use and expenditure of funds." 49:49:7.1.4.1.1.2.1.3,49,Transportation,VIII,,800,PART 800—ADMINISTRATIVE RULES,B,Subpart B—Delegations of Authority to Staff Members,,"§ 800.23 Delegation to the administrative law judges, Office of Administrative Law Judges.",NTSB,,,"[60 FR 61489, Nov. 30, 1995]",The Board delegates to the administrative law judges the authority generally detailed in its procedural regulations at Part 821 of this chapter. 49:49:7.1.4.1.1.2.1.4,49,Transportation,VIII,,800,PART 800—ADMINISTRATIVE RULES,B,Subpart B—Delegations of Authority to Staff Members,,§ 800.24 Delegation to the General Counsel.,NTSB,,,"[60 FR 61489, Nov. 30, 1995, as amended at 63 FR 71606, Dec. 29, 1998; 81 FR 75731, Nov. 1, 2016]","The Board delegates to the General Counsel the authority to: (a) Approve, disapprove, request more information, or otherwise handle requests for testimony of Board employees with respect to their participation in the investigation of accidents, and, upon receipt of notice that an employee has been subpoenaed, to make arrangements with the court either to have the employee excused from testifying or to give the employee permission to testify in accordance with the provisions of Part 835 of this Chapter. (b) Approve or disapprove in safety enforcement proceedings, for good cause shown, requests for extensions of time or for other changes in procedural requirements subsequent to the initial decision, grant or deny requests to file additional and/or amicus briefs pursuant to §§ 821.9 and 821.48 of this Chapter, and raise on appeal any issue the resolution of which he deems important to the proper disposition of proceedings under § 821.49 of this Chapter. (c) Approve or disapprove, for good cause shown, requests to extend the time for filing comments on proposed new or amended regulations. (d) Issue regulations for the purpose of making editorial changes or corrections in the Board's rules and regulations. (e) Issue orders staying or declining to stay, pending judicial review, orders of the Board suspending or revoking certificates, and consent to the entry of judicial stays with respect to such orders. (f) Compromise civil penalties in the case of violations arising under 49 U.S.C. chapter 11, subchapter IV, or any rule, regulation, or order issued thereunder. (g) Issue orders dismissing appeals from initial decisions of Board administrative law judges pursuant to the request of the appellant or, where the request is consensual, at the request of any party. (h) Correct Board orders by eliminating typographical, grammatical, and similar errors, and make editorial changes therein not involving matters of substance. (i) Take such action as appropriate or necessary adequately to compromise, settle, or otherwise represent the Board's interest in judicial or administrative actions to which the Board is a party or in which the Board is interested. (j) Dismiss late filed notices of appeal and appeal briefs for lack of good cause." 49:49:7.1.4.1.1.2.1.5,49,Transportation,VIII,,800,PART 800—ADMINISTRATIVE RULES,B,Subpart B—Delegations of Authority to Staff Members,,"§ 800.25 Delegation to the Directors of Office of Aviation Safety, Office of Railroad Safety, Office of Highway Safety, Office of Marine Safety, and Office of Pipeline and Hazardous Materials Safety.",NTSB,,,"[60 FR 61489, Nov. 30, 1995, as amended at 63 FR 71606, Dec. 29, 1998; 81 FR 75731, Nov. 1, 2016]","The Board delegates to the Directors of the Offices of Aviation, Railroad, Highway, Marine, and Pipeline and Hazardous Materials Safety, the authority to: (a) Order an investigation into the facts, conditions, and circumstances of accidents that the Board has authority to investigate. (b) Disclose factual information pertinent to all accidents or incidents as provided for in Part 801 of this chapter. (c) Determine the probable cause(s) of accidents in which the determination is issued in the “Brief of Accident” format, except that the Office Director will submit the findings of the accident investigation to the Board for determination of the probable cause(s) when (1) any Board Member so requests, (2) it appears to the Office Director that, because of significant public interest, a policy issue, or a safety issue of other matter, the determination of the probable cause(s) should be made by the Board, or (3) the accident investigation will be used to support findings in a special investigation or study. Provided, that a petition for reconsideration or modification of a determination of the probable cause(s) made under § 845.31 of this chapter shall be acted on by the Board. (d) Consistent with Board resources, investigate accidents as provided under 49 U.S.C. 1131 and the appendix to this part." 49:49:7.1.4.1.1.2.1.6,49,Transportation,VIII,,800,PART 800—ADMINISTRATIVE RULES,B,Subpart B—Delegations of Authority to Staff Members,,"§ 800.26 Delegation to the Chief, Public Inquiries Branch.",NTSB,,,"[63 FR 71606, Dec. 29, 1998, as amended at 81 FR 75731, Nov. 1, 2016]","The Board delegates to the Chief, Public Inquiries Branch, the authority to determine, initially, the withholding of a Board record from inspection or copying, pursuant to part 801 of this chapter." 49:49:7.1.4.1.1.2.1.7,49,Transportation,VIII,,800,PART 800—ADMINISTRATIVE RULES,B,Subpart B—Delegations of Authority to Staff Members,,§ 800.27 Delegation to investigative officers and employees of the Board.,NTSB,,,"[60 FR 61490, Nov. 30, 1995, as amended at 81 FR 75731, Nov. 1, 2016]","The Board delegates to any officer or employee of the Board designated by the Chairman the authority to sign and issue subpoenas, and administer oaths and affirmations, and to take depositions or cause them to be taken in connection with the investigation of transportation accidents or incidents." 49:49:7.1.4.1.1.2.1.8,49,Transportation,VIII,,800,PART 800—ADMINISTRATIVE RULES,B,Subpart B—Delegations of Authority to Staff Members,,§ 800.28 Delegation to the Chief Financial Officer.,NTSB,,,"[63 FR 71606, Dec. 29, 1998]","The Board delegates to the Chief Financial Officer the authority to settle claims for money damages of $2,500 or less against the United States arising under Section 2672 of 28 United States Code (the Federal Tort Claims Act) because of acts or omissions of Board employees." 49:49:7.1.4.1.1.3.1.1,49,Transportation,VIII,,800,PART 800—ADMINISTRATIVE RULES,C,Subpart C—Procedures for Adoption of Rules,,§ 800.30 Applicability.,NTSB,,,"[80 FR 57309, Sept. 23, 2015, as amended at 81 FR 75731, Nov. 1, 2016]","This subpart prescribes rulemaking procedures that apply to the issuance, amendment, and revocation of rules pursuant to 49 U.S.C. 1113(f)." 49:49:7.1.4.1.1.3.1.10,49,Transportation,VIII,,800,PART 800—ADMINISTRATIVE RULES,C,Subpart C—Procedures for Adoption of Rules,,§ 800.39 Additional rulemaking proceedings.,NTSB,,,,"The NTSB may initiate any further rulemaking proceedings it finds necessary or desirable. For example, interested persons may be invited to make oral arguments, to participate in conferences between the Board or a representative of the Board and interested persons at which minutes of the conference are kept, to appear at informal hearings presided over by officials designated by the Board, at which a transcript or minutes are kept, or participate in any other proceeding to assure informed administrative action and to protect the public interest." 49:49:7.1.4.1.1.3.1.11,49,Transportation,VIII,,800,PART 800—ADMINISTRATIVE RULES,C,Subpart C—Procedures for Adoption of Rules,,§ 800.40 Hearings.,NTSB,,,,"(a) Sections 556 and 557 of title 5, United States Code, do not apply to hearings held under this part. Unless otherwise specified, hearings held under this part are informal, fact-finding proceedings, at which there are no formal pleadings or adverse parties. Any rule issued in a case in which an informal hearing is held is not necessarily based exclusively on the record of the hearing. (b) The NTSB designates a representative to conduct any hearing held under this part. The General Counsel or a designated member of his or her staff may serve as legal officer at the hearing." 49:49:7.1.4.1.1.3.1.12,49,Transportation,VIII,,800,PART 800—ADMINISTRATIVE RULES,C,Subpart C—Procedures for Adoption of Rules,,§ 800.41 Adoption of final rules.,NTSB,,,,"Final rules are prepared by representatives of the office concerned and the Office of the General Counsel. The rule is then submitted to the Board for its consideration. If the Board adopts the rule, it is published in the Federal Register ." 49:49:7.1.4.1.1.3.1.13,49,Transportation,VIII,,800,PART 800—ADMINISTRATIVE RULES,C,Subpart C—Procedures for Adoption of Rules,,§ 800.42 Petitions for rulemaking.,NTSB,,,,"(a) Any interested person may petition the Chairman to establish, amend, or repeal a rule. (b) Each petition filed under this section must: (1) Be submitted in duplicate to the Chairman, National Transportation Safety Board, 490 L'Enfant Plaza SW., Washington, DC 20594-0003; (2) Set forth the text or substance of the rule or amendment proposed, or specify the rule the petitioner seeks to have repealed, as the case may be; (3) Explain the interest of the petitioner in the action requested; and (4) Contain any information and arguments available to the petitioner to support the action sought." 49:49:7.1.4.1.1.3.1.14,49,Transportation,VIII,,800,PART 800—ADMINISTRATIVE RULES,C,Subpart C—Procedures for Adoption of Rules,,§ 800.43 Processing of petition.,NTSB,,,,"(a) Unless the NTSB otherwise specifies, no public hearing, argument, or other proceeding is held directly on a petition before its disposition under this section. (b) Grants. If the agency determines the petition contains adequate justification, it initiates rule making action this subpart. (c) Denials. If the agency determines the petition does not justify rulemaking, it denies the petition. (d) Notification. Whenever the agency determines a petition should be granted or denied, the Office of the General Counsel prepares a notice of the grant or denial for issuance to the petitioner, and the agency issues it to the petitioner." 49:49:7.1.4.1.1.3.1.15,49,Transportation,VIII,,800,PART 800—ADMINISTRATIVE RULES,C,Subpart C—Procedures for Adoption of Rules,,§ 800.44 Direct final rulemaking procedures.,NTSB,,,,"A direct final rule makes regulatory changes and states those changes will take effect on a specified date unless the NTSB receives an adverse comment or notice of intent to file an adverse comment by the date specified in the direct final rule published in the Federal Register . (a) Types of actions appropriate for direct final rulemaking. Rules the Board determines to be non-controversial and unlikely to result in adverse public comments may be published in the final rule section of the Federal Register as direct final rules. These include non-controversial rules that: (1) Make non-substantive clarifications or corrections to existing rules; (2) Incorporate by reference the latest or otherwise updated versions of technical or industry standards; (3) Affect internal NTSB procedures; (4) Update existing forms; and (5) Make minor changes to rules regarding statistics and reporting requirements, such as a change in reporting period (for example, from quarterly to annually) or eliminating a type of data collection no longer necessary. (b) Adverse comment. An adverse comment is a comment the NTSB judges to be critical of the rule, to suggest the rule should not be adopted, or to suggest a change should be made to the rule. Under the direct final rule process, the NTSB does not consider the following types of comments to be adverse: (1) Comments recommending another rule change, unless the commenter states the direct final rule will be ineffective without the change; (2) Comments outside the scope of the rule and comments suggesting the rule's policy or requirements should or should not be extended to other topics outside the scope of the rule; (3) Comments in support of the rule; or (4) Comments requesting clarification. (c) Confirmation of effective date. The NTSB will publish a confirmation rule document in the Federal Register if it has not received an adverse comment or notice of intent to file an adverse comment by the date specified in the direct final rule. The confirmation rule document informs the public of the effective date of the rule. (d) Withdrawal of a direct final rule. (1) If the NTSB receives an adverse comment or a notice of intent to file an adverse comment within the comment period, it will publish a rule document in the Federal Register, before the effective date of the direct final rule, advising the public and withdrawing the direct final rule. (2) If the NTSB withdraws a direct final rule because of an adverse comment, the NTSB may issue a notice of proposed rulemaking if it decides to pursue the rulemaking." 49:49:7.1.4.1.1.3.1.16,49,Transportation,VIII,,800,PART 800—ADMINISTRATIVE RULES,C,Subpart C—Procedures for Adoption of Rules,,§ 800.45 Interim rulemaking procedures.,NTSB,,,,"(a) An interim rule may be issued when it is in the public interest to promulgate an effective rule while keeping the rulemaking open for further refinement. For example, an interim rule may be issued in instances when normal procedures for notice and comment prior to issuing an effective rule are not required, minor changes to the final rule may be necessary after the interim rule has been in place for some time, or the interim rule only implements portions of a proposed rule, while other portions of the proposed rule are still under development. (b) An interim rule will be published in the Federal Register with an effective date on or after the date of publication. After the effective date, an interim rule is enforceable and is codified in the next annual revision of the Code of Federal Regulations." 49:49:7.1.4.1.1.3.1.2,49,Transportation,VIII,,800,PART 800—ADMINISTRATIVE RULES,C,Subpart C—Procedures for Adoption of Rules,,§ 800.31 Public reading room.,NTSB,,,"[80 FR 57309, Sept. 23, 2015, as amended at 81 FR 75731, Nov. 1, 2016]","Information and data relevant to NTSB rulemaking actions, including notices of proposed rulemaking; comments received in response to notices; petitions for rulemaking and reconsideration; denials of petitions for rulemaking; and final rules are maintained in the NTSB's public reading room, located at 490 L'Enfant Plaza SW., Washington, DC 20594-2003." 49:49:7.1.4.1.1.3.1.3,49,Transportation,VIII,,800,PART 800—ADMINISTRATIVE RULES,C,Subpart C—Procedures for Adoption of Rules,,§ 800.32 Initiation of rulemaking.,NTSB,,,,The NTSB may initiate rulemaking either on its own motion or on petition by any interested person after a determination that grant of the petition is advisable. The NTSB may also consider the recommendations of other agencies of the United States. 49:49:7.1.4.1.1.3.1.4,49,Transportation,VIII,,800,PART 800—ADMINISTRATIVE RULES,C,Subpart C—Procedures for Adoption of Rules,,§ 800.33 Notice of proposed rulemaking.,NTSB,,,"[80 FR 57309, Sept. 23, 2015, as amended at 81 FR 75731, Nov. 1, 2016]","Unless the NTSB, for good cause, finds notice is impracticable, unnecessary, or contrary to the public interest, and incorporates that finding and a brief statement of the reasons for it in the rule, a notice of proposed rulemaking is issued and interested persons are invited to participate in the rulemaking proceedings under applicable provisions of 5 U.S.C. 553." 49:49:7.1.4.1.1.3.1.5,49,Transportation,VIII,,800,PART 800—ADMINISTRATIVE RULES,C,Subpart C—Procedures for Adoption of Rules,,§ 800.34 Contents of notices of proposed rulemaking.,NTSB,,,,"(a) Each notice of proposed rulemaking is published in the Federal Register . (b) Each notice includes: (1) A statement of the time, place, and nature of the proposed rulemaking proceeding; (2) A reference to the authority under which it is issued; (3) A description of the subjects and issues involved or the substance and terms of the proposed rule; (4) A statement of the time within which written comments must be submitted; and (5) A statement of how and to what extent interested persons may participate in the proceedings." 49:49:7.1.4.1.1.3.1.6,49,Transportation,VIII,,800,PART 800—ADMINISTRATIVE RULES,C,Subpart C—Procedures for Adoption of Rules,,§ 800.35 Participation of interested persons.,NTSB,,,"[80 FR 57309, Sept. 23, 2015, as amended at 81 FR 75731, Nov. 1, 2016]","(a) Any interested person may participate in a rulemaking proceeding by submitting written comments,information, views or arguments. (b) In its discretion, the agency may invite any interested person to participate in the rulemaking procedures described in this subpart." 49:49:7.1.4.1.1.3.1.7,49,Transportation,VIII,,800,PART 800—ADMINISTRATIVE RULES,C,Subpart C—Procedures for Adoption of Rules,,§ 800.36 Petitions for extension of time to comment.,NTSB,,,,"A petition for extension of the time to submit comments must be received not later than 10 days before the end of the comment period stated in the notice. The petition must be submitted to: General Counsel, National Transportation Safety Board, 490 L'Enfant Plaza SW., Washington, DC 20594-2003. The filing of the petition does not automatically extend the time for petitioner's comments. Such a petition is granted only if the petitioner shows good cause for the extension, and if the extension is consistent with the public interest. If an extension is granted, it is granted to all persons, and the NTSB will publish a notice of the extension of the comment period in the Federal Register ." 49:49:7.1.4.1.1.3.1.8,49,Transportation,VIII,,800,PART 800—ADMINISTRATIVE RULES,C,Subpart C—Procedures for Adoption of Rules,,§ 800.37 Contents of written comments.,NTSB,,,,"All written comments shall be in English. Unless otherwise specified in a notice requesting comments, comments may not exceed 15 pages in length, but necessary attachments may be appended to the submission without regard to the 15-page limit. Any commenter shall submit as a part of his or her written comments all material he or she considers relevant to any statement of fact made in the comment. Commenters should avoid incorporation by reference. However, if incorporation by reference is necessary, the incorporated material shall be identified with respect to document and page. The NTSB may reject comments if they are frivolous, abusive, or repetitious. The NTSB may also reject comments filed electronically if the commenter does not adhere to the electronic filing instructions at the Federal Docket Management System Web site." 49:49:7.1.4.1.1.3.1.9,49,Transportation,VIII,,800,PART 800—ADMINISTRATIVE RULES,C,Subpart C—Procedures for Adoption of Rules,,§ 800.38 Consideration of comments received.,NTSB,,,,All timely comments are considered before final action is taken on a rulemaking proposal. Late filed comments may be considered to the extent practicable. 7:7:7.1.2.8.1.0.10.2,7,Agriculture,VIII,A,800,PART 800—GENERAL REGULATIONS,,,,§ 800.1 Mission.,AMS,,,"[54 FR 9197, Mar. 6, 1989]","The mission of the Federal Grain Inspection Service is to facilitate the marketing of grain, oilseeds, pulses, rice, and related commodities by: (a) Establishing descriptive standards and terms, (b) Accurately and consistently certifying quality, (c) Providing for uniform official inspection and weighing, (d) Carrying out assigned regulatory and service responsibilities, and (e) Providing the framework for commodity quality improvement incentives to both domestic and foreign buyers." 7:7:7.1.2.8.1.0.10.3,7,Agriculture,VIII,A,800,PART 800—GENERAL REGULATIONS,,,,§ 800.2 Administrator.,AMS,,,"[60 FR 5835, Jan. 31, 1995]","The Administrator is delegated, from the Secretary, responsibility for administration of the United States Grain Standards Act and responsibilities under the Agricultural Marketing Act of 1946 (7 U.S.C. 1621 et seq. ). The Administrator is responsible for the establishment of policies, guidelines, and regulations by which the Service is to carry out the provisions of the Act and the Agricultural Marketing Act of 1946. The regulations promulgated under the Agricultural Marketing Act of 1946 appear at part 68 of this title (7 CFR part 68). The Administrator is authorized by the Secretary to take any action required by law or considered to be necessary and proper to the discharge of the functions and services under the Act. The Administrator may delegate authority to the Deputy Administrator and other appropriate officers and employees. The Administrator may, in emergencies or other circumstances which would not impair the objectives of the Act, suspend for period determined by the Administrator any provision of the regulations or official grain standards. The Administrator may authorize research; experimentation; and testing of new procedures, equipment, and handling techniques to improve the inspection and weighing of grain. The Administrator may waive the official inspection and official weighing requirements pursuant to Section 5 of the Act." 7:7:7.1.2.8.1.0.10.4,7,Agriculture,VIII,A,800,PART 800—GENERAL REGULATIONS,,,,§ 800.3 Nondiscrimination—policy and provisions.,AMS,,,,"In implementing, administering, and enforcing the Act and the regulations, standards, and instructions, it is the policy of the Service to promote adherence to the provisions of the Civil Rights Act of 1964 (42 U.S.C. 2000a et seq. ), (Pub. L. 88-352)." 7:7:7.1.2.8.1.0.10.5,7,Agriculture,VIII,A,800,PART 800—GENERAL REGULATIONS,,,,"§ 800.4 Procedures for establishing regulations, official standards, and official criteria.",AMS,,,,"Notice of proposals to prescribe, amend, or revoke regulations, official standards, and official criteria under the Act shall be published in accordance with applicable provisions of the Administrative Procedure Act (5 U.S.C. 551, et seq. ). Proposals to establish, amend, or revoke grain standards will be made effective not less than 1 calendar year after promulgation unless, for good cause, the Service determines that the public health, interest, or safety require that they become effective sooner. Any interested person desiring to file a petition for the issuance, amendment, or revocation of regulations, Official U.S. Standards for Grain, or official criteria may do so in accordance with § 1.28 of the regulations of the Office of the Secretary of Agriculture (7 CFR 1.28)." 7:7:7.1.2.8.1.0.10.6,7,Agriculture,VIII,A,800,PART 800—GENERAL REGULATIONS,,,,§ 800.5 Complaints and reports of alleged violations.,AMS,,,"[45 FR 15810, Mar. 11, 1980, as amended at 54 FR 5924, Feb. 7, 1989]","(a) General. Except as provided in paragraphs (b) and (c) of this section, complaints and reports of violations involving the Act or the regulations, standards, and instructions issued under the Act should be filed with the Service in accordance with § 1.133 of the regulations of the Office of the Secretary of Agriculture (7 CFR 1.133) and with the regulations and the instructions. (b) Reinspection, review of weighing, and appeal services. Complaints involving the results of official inspection or Class X or Class Y weighing services shall, to the extent practicable, be submitted as requests for a reinspection service, a review of weighing service, an appeal inspection service, or a Board appeal inspection service as set forth in these regulations. (c) Foreign buyer complaints. Inquiries or complaints from importers or other purchasers in foreign countries involving alleged discrepancies in the quality or weight of officially inspected or Class X weighed export grain shall, to the extent possible, be submitted by the importers or purchasers to the appropriate U.S. Agricultural Attache in accordance with § 2.68(a)(14) of the regulations of the Office of the Secretary of Agriculture (7 CFR 2.68(a)(14)) and the instructions issued by the Foreign Agricultural Service of the Department." 7:7:7.1.2.8.1.0.10.7,7,Agriculture,VIII,A,800,PART 800—GENERAL REGULATIONS,,,,§ 800.6 Provisions for hearings.,AMS,,,,"Opportunities will be provided for hearings prescribed or authorized by sections 7(g)(3), 7A(c)(2), 9, 10(d), and 17A(d) of the Act, and the hearings shall be conducted in accordance with the Rules of Practice Governing Formal Adjudicatory Administrative Proceedings Instituted by the Secretary under Various Statutes (7 CFR, part 1, subpart H)." 7:7:7.1.2.8.1.0.10.8,7,Agriculture,VIII,A,800,PART 800—GENERAL REGULATIONS,,,,"§ 800.7 Information about the Service, Act, and regulations.",AMS,,,"[84 FR 45646, Aug. 30, 2019]","Information about the Agricultural Marketing Service, Service, Act, regulations, official standards, official criteria, rules of practice, instructions, and other matters related to the official inspection or Class X or Class Y weighing of grain may be obtained by telephoning or writing the Service at its headquarters or any one of its field offices at the numbers and addresses listed on the Service's website." 7:7:7.1.2.8.1.0.10.9,7,Agriculture,VIII,A,800,PART 800—GENERAL REGULATIONS,,,,§ 800.8 Public information.,AMS,,,"[48 FR 57467, Dec. 30, 1983, as amended at 54 FR 5924, Feb. 7, 1989; 60 FR 5836, Jan. 31, 1995; 84 FR 45646, Aug. 30, 2019]","(a) General. This section is issued in accordance with §§ 1.1 through 1.23 of the regulations of the Secretary of Agriculture in part 1, subpart A, of subtitle A of title 7 (7 CFR 1.1 through 1.23), and appendix A thereto, implementing the Freedom of Information Act (5 U.S.C. 552). The Secretary's regulations, as implemented by this section, govern the availability of records of the Service to the public. (b) Public inspection and copying. Materials maintained by the Service, including those described in 7 CFR 1.5, will be made available, upon a request which has not been denied, for public inspection and copying at the U.S. Department of Agriculture, Agricultural Marketing Service, at 14th Street and Independence Avenue, SW., Washington, D.C. 20250. The public may request access to these materials during regular working hours, 8:00 a.m. to 4:30 p.m., est, Monday through Friday except for holidays. (c) Indexes. FGIS shall maintain an index of all material required to be made available in 7 CFR 1.5. Copies of these indexes will be maintained at the location given in paragraph (b) of this section. Notice is hereby given that quarterly publication of these indexes is unnecessary and impracticable, because the material is voluminous and does not change often enough to justify the expense of quarterly publication. However, upon specific request, copies of any index will be provided at a cost not to exceed the direct cost of duplication. (d) Requests for records. Requests for records under 5 U.S.C. 552(a)(3) shall be made in accordance with 7 CFR 1.6 and shall be addressed as follows: AMS FOIA Officer, Agricultural Marketing Service, FOIA Request, 1400 Independence Avenue SW, Room 2095-S, Stop 0203, Washington, DC 20250-0203. (e) Appeals. Any person whose request under paragraph (d) of this section is denied shall have the right to appeal such denial in accordance with 7 CFR 1.13. Appeals shall be addressed to the Administrator, Agricultural Marketing Service, FOIA Appeal, 1400 Independence Avenue SW, Room 3071-S, Stop 0201, Washington, DC 20250-0201." 7:7:7.1.2.8.1.0.11.10,7,Agriculture,VIII,A,800,PART 800—GENERAL REGULATIONS,,,,§ 800.15 Services.,AMS,,,"[50 FR 49668, Dec. 4, 1985, as amended at 57 FR 2439, Jan. 22, 1992; 81 FR 49860, July 29, 2016]","(a) General. These regulations implement requirements for a national inspection and weighing system. This system promotes the uniform and accurate application of the official grain standards and provides inspection and weighing services required by the Act and as requested by applicants for official services. The types and kinds of services available under the Act and regulations can be obtained at all specified service points in the United States and on U.S. grain in Canadian ports. (b) Responsibilities for complying with the official inspection, aflatoxin testing, and weighing requirements —(1) Export grain. Exporters are responsible for (i) complying with all inspection, Class X weighing, and other certification provisions and requirements of section 5(a)(1) of the Act and the regulations applicable to export grain and (ii) having all corn, as defined in § 810.401, exported from the United States tested for aflatoxin contamination unless the buyer and seller agree not to have the corn tested. The Service shall perform the aflatoxin testing service unless the buyer and seller agree to have the corn tested by an entity other than the Service. (2) Grain in marked containers. When grain is in a container that bears an official grade designation or mark, the person who places the designation or mark on the container or the person who places the grain in a container that bears the designation or mark shall be responsible for determining that the grain has been inspected or weighed by official personnel and qualifies for the official grade designation or mark. (3) Grain for which representations have been made. Any person who makes a representation that (i) grain has been officially inspected or weighed; or (ii) grain has been officially inspected or weighed and found to be of a particular kind, class, quality, condition, or weight; or (iii) particular facts have been established with respect to the grain by official inspection or weighing, shall be responsible for determining that the representation is true and is not in violation of the Act and regulations." 7:7:7.1.2.8.1.0.11.11,7,Agriculture,VIII,A,800,PART 800—GENERAL REGULATIONS,,,,§ 800.16 Certification requirements for export grain.,AMS,,,"[50 FR 49668, Dec. 4, 1985, as amended at 57 FR 2439, Jan. 22, 1992]","(a) General. Official Export Grain Inspection and Weight Certificates, Official Export Grain Inspection Certificates, and Official Export Grain Weight Certificates for bulk or sacked grain shall be issued according to § 800.162 for export grain loaded by an export elevator. Only these types of export certificates showing the official grade, official aflatoxin test results if required under the Act and the regulations, and/or the Class X weight of the grain shall be considered to be in compliance with inspection and weighing requirements under the Act for export grain. (b) Promptly furnished. Export certificates shall be considered promptly furnished if they are forwarded by the shipper or the shipper's agent to the consignee not later than 10 business days after issuance." 7:7:7.1.2.8.1.0.11.12,7,Agriculture,VIII,A,800,PART 800—GENERAL REGULATIONS,,,,§ 800.17 Special inspection and weighing requirements for sacked export grain.,AMS,,,"[50 FR 49668, Dec. 4, 1985]","(a) General. Subject to the provisions of § 800.18, sacked export grain shall be (1) officially inspected on the basis of official samples obtained with an approved sampling device and operated in accordance with instructions, (2) Class X weighed or checkweighed, and (3) officially checkloaded by official personnel at the time the grain is loaded aboard the export carrier, in accordance with the provisions of paragraphs (b) and (c) of this section. (b) Services at time of loading. When official sampling, official inspection, Class X weighing or checkweighing, and checkloading of sacked export grain loaded aboard an export carrier is performed at one location and time, official export inspection and weight certificate(s) which identify the export carrier shall be issued. (c) Services prior to loading. When official sampling, official inspection, and Class X weighing or checkweighing of sacked export grain is performed prior to the date of loading aboard an export carrier, official “OUT” certificates shall be issued. An examination by official personnel for condition and checkloading of the grain shall be made as the grain is loaded aboard the export carrier. If the examination for condition and the checkloading shows that the identity or quantity of the grain has not changed or the condition of the grain has not changed beyond expected variations prescribed in the instruction, official export inspection and weight certificates shall be issued on the basis of the official “OUT” certificates and the checkloading. If the identity, quantity, or the condition has changed, official export inspection and weight certificates shall be issued on the basis of the most representative samples, including weight samples, obtained at the time the grain is loaded aboard the export carrier." 7:7:7.1.2.8.1.0.11.13,7,Agriculture,VIII,A,800,PART 800—GENERAL REGULATIONS,,,,§ 800.18 Waivers of the official inspection and Class X weighing requirements.,AMS,,,"[50 FR 49669, Dec. 4, 1985, as amended at 70 FR 21923, Apr. 28, 2005; 70 FR 73559, Dec. 13, 2005; 75 FR 41695, July 19, 2010; 76 FR 45399, July 29, 2011; 81 FR 49860, July 29, 2016]","(a) General. Waivers from the official inspection and Class X weighing requirements for export grain under section 5 of the Act shall be provided in accordance with this section and the Act. (b) Waivers —(1) 15,000 metric-ton waiver. Official inspection and Class X weighing requirements apply only to exporters and individual elevator operators who (i) exported 15,000 metric tons or more of grain during the preceding calendar year, or (ii) have exported 15,000 metric tons or more of grain during the current calendar year. Exporters and elevator operators who are granted a waiver by reason of this paragraph shall, as a condition of the waiver, keep such accounts, records, and memorandum to fully and correctly disclose all transactions concerning lots of all export grain shipments. In addition, the exporters or elevator operators shall notify the Service in writing of the intention to export grain under this waiver. In the case of lots waived under this provision, if such lots are required by contract to be inspected or weighed, or if the lots are represented by official inspection or weight certificates, then such certificates shall meet the requirements of section 5 of the Act. (2) Grain exported for seeding purposes. Official inspection and Class X weighing requirements do not apply to grain exported for seeding purposes, provided that (i) the grain is (A) sold or consigned for sale and invoiced as seed; and (B) identified as seed for seeding purposes on the Shipper's Export Declaration; and (ii) records pertaining to these shipments are made available, upon request by the Service, for review or copying purposes. (3) Grain shipped in bond. Official inspection and weighing requirements do not apply to grain that is shipped from a foreign country to a foreign country through the United States in bond in accordance with applicable regulations of the United States Customs Service (19 CFR part 18). (4) Grain exported by rail or truck to Canada or Mexico. Inspection and weighing requirements do not apply to grain exported by rail or truck from the United States to Canada or Mexico. (5) Grain not sold by grade. Official inspection requirements may be waived by the Service on a shipment-by-shipment basis for export grain not sold, offered for sale, or consigned for sale by official grade if (i) the contract and any amendments clearly show that the buyer and seller mutually agree to ship the grain without official inspection and (ii) a copy of the contract and any amendments is furnished in advance of loading, along with a completed application on a form prescribed by the Service. (6) Service not available. Upon request, any required official inspection or Class X weighing of grain may be waived on a shipment-by-shipment basis if (i) official personnel are not and will not be available within a 24-hour period to perform needed inspection or weighing services and (ii) both the buyer and seller of the grain are made aware that the grain has not been officially inspected or Class X weighed. (7) Emergency waiver. (i) Upon request, the requirements for official inspection or Class X weighing will be waived whenever the Service determines that an emergency exists that precludes official inspection or Class X weighing; (ii) To qualify for an emergency waiver, the exporter or elevator operator must submit a timely written request to the Service for the emergency waiver and also comply with all conditions that the Service may require. (8) High quality specialty grain shipped in containers. Official inspection and weighing requirements do not apply to high quality specialty grain exported in containers. Records generated during the normal course of business that pertain to these shipments must be made available to the Service upon request, for review or copying. These records must be maintained for a period of 3 years." 7:7:7.1.2.8.1.0.12.14,7,Agriculture,VIII,A,800,PART 800—GENERAL REGULATIONS,,,,§ 800.25 Required elevator and merchandising records.,AMS,,,"[51 FR 1768, Jan. 15, 1986]","(a) Elevator and merchandiser recordkeeping. Every person and every State or political subdivision of a State that owns or operates an elevator and every merchandiser that has obtained or obtains official inspection or official weighing services other than (1) submitted sample inspection service, or (2) official sampling service, or (3) official stowage examination service shall keep such accounts, records, and memoranda that fully and correctly disclose all transactions concerning the lots of grain for which the elevator or merchandiser received official services, except as provided under § 800.18. (b) Retention period. Records specified in this section may be disposed of after a period of 3 years from the date of the official service; provided, the 3-year period may be extended if the elevator owner or operator, or merchandiser is notified in writing by the Administrator that specific records should be retained for a longer period for effective administration and enforcement of the Act. This requirement does not restrict or modify the requirements of any other Federal, State, or local statute concerning recordkeeping." 7:7:7.1.2.8.1.0.12.15,7,Agriculture,VIII,A,800,PART 800—GENERAL REGULATIONS,,,,§ 800.26 Access to records and facilities.,AMS,,,"[51 FR 1768, Jan. 15, 1986]","(a) Inspection of records and facilities. Prior to the examination of records or inspection of facilities by an authorized representative of the Secretary or the Administrator, the authorized representative shall contact or otherwise notify the elevator manager or manager's representative of their presence and furnish proof of identity and authority. While in the elevator, the authorized representative shall abide by the safety regulations in effect at the elevator. Every elevator owner and operator and every merchandiser shall permit authorized representatives of the Secretary or Administrator to enter its place of business during normal business hours and have access to the facilities and to inspect any books, documents, papers, and records that are maintained by such persons. Such access and inspection will be to effectuate the purpose, provisions, and objectives of the Act and to assure the integrity of official services under the Act or of any official transaction with which the Act is concerned. All copies of such records will be made at the Service's expense. Reasonable accommodations shall be made available to the duly authorized representative by elevator owners and operators, and merchandisers for such examination of records. (b) Disclosure of business information. FGIS employees or persons acting for FGIS under the Act shall not, without the consent of the elevator operator or merchandiser concerned, divulge or make known in any manner, any facts or information acquired pursuant to the Act and regulations except as authorized by the Administrator, by a court of competent jurisdiction, or otherwise by law." 7:7:7.1.2.8.1.0.13.16,7,Agriculture,VIII,A,800,PART 800—GENERAL REGULATIONS,,,,§ 800.30 Foreign commerce grain business.,AMS,,,"[48 FR 44455, Sept. 29, 1983]","“Foreign commerce grain business” is defined as the business of buying grain for sale in foreign commerce or the business of handling, weighing, or transporting grain for sale in foreign commerce. This provision shall not include: (a) Any person who only incidentally or occasionally buys for sale, or handles, weighs, or transports grain for sale and is not engaged in the regular business of buying grain for sale, or handling, weighing, or transporting grain for sale; (b) Any producer of grain who only incidentally or occasionally sells or transports grain which the producer has purchased; (c) Any person who transports grain for hire and does not own a financial interest in such grain; or (d) Any person who buys grain for feeding or processing and not for the purpose of reselling and only incidentally or occasionally sells such grain as grain." 7:7:7.1.2.8.1.0.13.17,7,Agriculture,VIII,A,800,PART 800—GENERAL REGULATIONS,,,,§ 800.31 Who must register.,AMS,,,"[48 FR 44453 and 44455, Sept. 29, 1983, as amended at 54 FR 5924, Feb. 7, 1989]","Each person who has engaged in foreign commerce grain business totaling 15,000 or more metric tons during the preceding or current calendar year must register with the Service and shall be deemed to be regularly engaged in foreign commerce grain business. This includes foreign-based firms operating in the United States but does not include foreign governments or their agents. The Service will, upon request, register persons not required to register under this section if they comply with the requirements of §§ 800.33 and 800.34." 7:7:7.1.2.8.1.0.13.18,7,Agriculture,VIII,A,800,PART 800—GENERAL REGULATIONS,,,,§ 800.32 When to register.,AMS,,,"[48 FR 44453 and 44455, Sept. 29, 1983, as amended at 54 FR 5924, Feb. 7, 1989]","A person shall submit an application for registration to the Service at least 30 calendar days before regularly engaging in foreign commerce grain business according to § 800.31. For good cause shown, the Service may waive this 30-day requirement." 7:7:7.1.2.8.1.0.13.19,7,Agriculture,VIII,A,800,PART 800—GENERAL REGULATIONS,,,,§ 800.33 How to register.,AMS,,,"[48 FR 44453 and 44456, Sept. 29, 1983, as amended at 54 FR 5924, Feb. 7, 1989]","Any person who is required or desires to register must submit an application for registration to the Service. Application forms can be obtained from the Service. Each application shall: (a) Be typewritten or legibly written in English; (b) include all information required by the application form; and (c) be signed by the applicant. The information required by this paragraph may be submitted to the Service via telephone, subject to written confirmation. An applicant shall furnish any additional information requested by the Service for consideration of the application." 7:7:7.1.2.8.1.0.13.20,7,Agriculture,VIII,A,800,PART 800—GENERAL REGULATIONS,,,,§ 800.34 Registration fee.,AMS,,,"[48 FR 44456, Sept. 29, 1983, as amended at 89 FR 48265, June 6, 2024; 90 FR 534, Jan. 6, 2025]","An applicant shall submit the registration fee prescribed in § 800.71 with the completed application. If an application is dismissed, the fee shall be refunded by the Service. No fee or portion of a fee shall be refunded if a person is registered and the registration is subsequently suspended or revoked under § 800.39." 7:7:7.1.2.8.1.0.13.21,7,Agriculture,VIII,A,800,PART 800—GENERAL REGULATIONS,,,,§ 800.35 Review of applications.,AMS,,,"[48 FR 44456, Sept. 29, 1983]","(a) The Service shall review each application to determine if it complies with §§ 800.32, 800.33, and 800.34. If the application complies and the fee has been paid, the applicant shall be registered. (b) If the application does not comply with §§ 800.32, 800.33, and 800.34 and the omitted information prevents a satisfactory review by the Service, the applicant shall be provided an opportunity to submit the needed information. If the needed information is not submitted within a reasonable time, the application may be dismissed. The Service shall promptly notify the applicant, in writing, of the reasons for the dismissal." 7:7:7.1.2.8.1.0.13.22,7,Agriculture,VIII,A,800,PART 800—GENERAL REGULATIONS,,,,§ 800.36 Certificates of registration.,AMS,,,"[48 FR 44456, Sept. 29, 1983, as amended at 89 FR 48265, June 6, 2024; 90 FR 534, Jan. 6, 2025]","The Service shall furnish the applicant with an original and three copies of the registration certificate. The registration shall be effective on the issue date shown on the certificate. Each certificate of registration is issued on the condition that the registrant will comply with all provisions of the Act, regulations, and instructions. The Service shall charge a fee, in accordance with § 800.71, for each additional copy of a certificate of registration requested by a registrant." 7:7:7.1.2.8.1.0.13.23,7,Agriculture,VIII,A,800,PART 800—GENERAL REGULATIONS,,,,§ 800.37 Notice of change in information.,AMS,,,"[48 FR 44453 and 44456, Sept. 29, 1983, as amended at 54 FR 5924, Feb. 7, 1989]","Each registrant shall notify the Service within 30 days of any change in the information contained in the application for registration. If the notice is submitted orally, it shall be promptly confirmed in writing." 7:7:7.1.2.8.1.0.13.24,7,Agriculture,VIII,A,800,PART 800—GENERAL REGULATIONS,,,,§ 800.38 Termination and renewal of registration.,AMS,,,"[48 FR 44456, Sept. 29, 1983]",Each certificate of registration shall terminate on December 31 of the calendar year for which it is issued. The Service shall send a letter to each registrant notifying the registrant of the impending termination of the registration and providing instructions for requesting renewal. The registration may be renewed in accordance with §§ 800.33 and 800.34. Failure to receive the letter shall not exempt registrants from the responsibility of renewing their registration if required by § 800.31. 7:7:7.1.2.8.1.0.13.25,7,Agriculture,VIII,A,800,PART 800—GENERAL REGULATIONS,,,,§ 800.39 Suspension or revocation of registration for cause.,AMS,,,"[48 FR 44456, Sept. 29, 1983]","(a) General. Registration is subject to suspension or revocation whenever the Administrator determines that the registrant has violated any provision of the Act or regulations, or has been convicted of any violation involving the handling, weighing, or inspection of grain under Title 18 of the United States Code. (b) Procedure. Before the Service suspends or revokes a registration, the registrant (hereinafter the “respondent”): (1) Shall be notified of the proposed action and the reasons therefor and (2) shall be afforded opportunity for a hearing in accordance with the Rules of Practice Governing Formal Adjudicatory Proceedings Instituted by the Secretary under Various Statutes (7 CFR, 1.130 through 1.151). Prior to formal adjudicatory proceedings, the Service may allow the respondent to express views on the action proposed by the Service in an informal conference before the Administrator. If the Service and the respondent enter into a consent agreement, no formal adjudicatory proceedings shall be initiated." 7:7:7.1.2.8.1.0.14.26,7,Agriculture,VIII,A,800,PART 800—GENERAL REGULATIONS,,,,§ 800.45 Availability of official services.,AMS,,,"[49 FR 30913, Aug. 2, 1984, as amended at 50 FR 45392, Oct. 31, 1985; 54 FR 5924, Feb. 7, 1989]","(a) Original inspection and weighing services. Original inspection and weighing services on grain are available according to this section and §§ 800.115 through 800.118 when requested by an interested person. (b) Reinspection, review of weighing, and appeal inspection services. Reinspection, review of weighing, appeal inspection, and Board appeal inspection services are available when requested by an interested person, according to §§ 800.125 through 800.129 and §§ 800.135 through 800.139. (c) Proof of authorization. If an application for official services is filed by a person representing the applicant, the agency or the field office receiving the application may require written proof of the authority to file the application." 7:7:7.1.2.8.1.0.14.27,7,Agriculture,VIII,A,800,PART 800—GENERAL REGULATIONS,,,,§ 800.46 Requirements for obtaining official services.,AMS,,,"[49 FR 30915, Aug. 2, 1984, as amended at 49 FR 49587, Dec. 21, 1984; 50 FR 45392, Oct. 31, 1985; 54 FR 5924, Feb. 7, 1989]","(a) Consent and agreement by applicant. In submitting a request for official services, the applicant and the owner of the grain consent to the special and general requirements specified in paragraphs (b) and (c) of this section. These requirements are essential to carry out the purposes or provisions of the Act. (b) General requirements —(1) Access to grain. Grain on which official services are to be performed shall, except as provided in §§ 800.85, 800.86, 800.98, and 800.99, be made accessible by the applicant for the performance of the requested official service and related monitoring and supervision activities. For the purposes of this section, grain is not “accessible” if it is offered for official services (i) in containers or carriers that are closed and cannot, with reasonable effort, be opened by or for official personnel; (ii) when any portion is located so as to prohibit the securing or a representative sample; or (iii) under conditions prescribed in the instructions as being hazardous to the health or safety of official personnel. (2) Working space. When official services are performed at an elevator, adequate and separate space must be provided by the applicant for the performance of the requested service and related monitoring and supervision activities. Space will be “adequate” if it meets the space, location, and safety requirements specified in the instructions. (3) Notice of changes. The operator of each facility at which official services are performed must notify the appropriate agency or field office promptly, in full detail, of changes in the grain handling and weighing facilities, equipment, or procedures at the elevator that could or would affect the proper performance of official services. (4) Loading and unloading conditions. As applicable, each applicant for official services must provide or arrange for suitable conditions in the (i) loading and unloading areas and the truck and railroad holding areas; (ii) gallery and other grain-conveying areas; (iii) elevator legs, distributor, and spout areas; (iv) pier or dock areas; (v) deck and stowage areas in the carrier; and (vi) equipment used in loading or unloading and handling the grain. Suitable conditions are those which will facilitate accurate inspection and weighing, maintain the quantity and the quality of the grain that is to be officially inspected or weighed, and not be hazardous to the health and safety of official personnel, as prescribed in the instructions. (5) Timely arrangements. Requests for official service shall be made in a timely manner; otherwise, official personnel may not be available to provide the requested service. For the purpose of this paragraph, “timely manner” shall mean not later than 2 p.m., local time, of the preceding business day. (6) Observation of activities. Each applicant for official services must provide any interested person, or their agent, an opportunity to observe sampling, inspection, weighing, and loading or unloading of grain. Appropriate observation areas shall be mutually defined by the Service and facility operator. The areas shall be safe and shall afford a clear and unobstructed view of the performance of the activity, but shall not permit a close over-the-shoulder type of observation by the interested person. (7) Payment of bills. Each applicant, for services under the Act, must pay bills for the services according to §§ 800.70 through 800.73. (8) Written confirmations. When requested by the agency or field office, verbal requests for official services shall be confirmed in writing. Each written request shall be signed by the applicant, or the applicant's agent, and shall show or be accompanied by the following information: (i) The identification, quantity, and specific location of the grain; (ii) The name and mailing address of the applicant; (iii) The kind and scope of services desired; and (iv) Any other information requested by the agency or field office. (9) Names and addresses of interested persons. When requested, each applicant for official services shall show on the application form the name and address of each known interested person. (10) Surrender of superseded certificates. When a request for official service results in a certificate being superseded, the superseded certificate must be promptly surrendered. (11) Recordkeeping and access. Each applicant for official services must comply with applicable recordkeeping and access-to-facility provisions in §§ 800.25 and 800.26. (12) Monitoring equipment. Owners and operators of elevators shall, upon a finding of need by the Administrator, provide equipment necessary for the monitoring by official personnel of grain loading, unloading, handling, sampling, weighing, inspection, and related activities. The finding of need will be based primarily on a consideration of manpower and efficiency. (c) Special requirements for official Class X and Class Y weighing services —(1) General. Weighing services shall be provided only at weighing facilities which have met the conditions, duties, and responsibilities specified in section 7A(f) of the Act and this section of the regulations. Weighing services will be available only in accordance with the requirements of § 800.115. Facilities desiring weighing services should contact the Service in advance to allow the Service time to determine if the facility complies with the provisions of the Act and regulations. (2) Conditions. The facility shall provide the following information annually to the Service: (i) The facility owner's name and address; (ii) The facility operator's name and address; (iii) The name of each individual employed by the facility as a weigher and a statement that each individual: (A) Has a technical ability to operate grain weighing equipment and (B) Has a reputation for honesty and integrity; (iv) A blueprint or similar drawing of the facility showing the location of: (A) The loading, unloading, and grain handling systems; (B) The scale systems used or to be used in weighing grain; and (C) The bins and other storage areas; (v) The identification of each scale in the facility that is to be used for weighing grain under the Act; (vi) The following information regarding automated data processing systems: (A) Overall system intent, design, and layout; (B) Make, model, and technical specifications of all hardware; (C) Description of software, language used, and flow charts of all programs, subprograms, routines, and subroutines; and (D) Complete operating instructions; and (vii) Any other information deemed necessary to carry out the provisions of the Act. If a facility has, or plans to have, an automated data processing system which is used in conjunction with any portion of the scale system, grain handling system, or the preparing or printing of official weight certificates, the facility shall make available to the Service sufficient documentation to ensure that the system cannot be used deceptively or otherwise provide inaccurate information. The Service or approved scale testing and certification organization shall conduct an onsite review to evaluate the performance and accuracy of each scale that will be used for weighing grain under the Act, and the performance of the grain loading, unloading, and related grain handling equipment and systems. (3) Duties and responsibilities of weighing facilities requesting official services —(i) Providing official services. Upon request, each weighing facility shall permit official weighing services to be performed promptly. (ii) Supervision. Each weighing facility shall supervise its employees and shall take action necessary to assure that employees are performing their duties according to the Act, regulations, and instructions and are not performing prohibited functions or are not involved in any action prohibited by the Act, regulations, and instructions. (iii) Facilities and equipment —(A) General. Each weighing facility shall obtain and maintain facilities and equipment which the Service determines are needed for weighing services performed at the facility. Each facility shall operate and shall maintain each scale system and related grain handling system used in weighing according to instructions issued by the manufacturer and by the Service. A scale log book for each approved scale used for official weighing services shall be maintained according to instructions at each weighing facility. (B) Malfunction of scales. Scales or scale systems that are operating in other than a correct and approved manner shall not be used for weighing grain under the Act. Before the malfunctioning scale or scale system can be used again for weighing grain under the Act, it shall be repaired and determined to be operating properly by the Service or approved scale testing and certification organization. (iv) Oral directives. FGIS oral directives issued to elevator personnel shall be confirmed in writing upon request by elevator management. Whenever practicable, the Service shall issue oral directives through elevator management officials." 7:7:7.1.2.8.1.0.14.28,7,Agriculture,VIII,A,800,PART 800—GENERAL REGULATIONS,,,,§ 800.47 Withdrawal of request for official services.,AMS,,,"[49 FR 30915, Aug. 2, 1984]","An applicant may withdraw a request for official services any time before official personnel release results, either verbally or in writing. See § 800.51 for reimbursement of expenses, if any." 7:7:7.1.2.8.1.0.14.29,7,Agriculture,VIII,A,800,PART 800—GENERAL REGULATIONS,,,,§ 800.48 Dismissal of request for official services.,AMS,,,"[49 FR 30915, Aug. 2, 1984, as amended at 50 FR 45392, Oct. 31, 1985]","(a) Conditions for dismissal —(1) General. An agency or the Service shall dismiss requests for official services when (i) § 800.76 prohibits the requested service; (ii) performing the requested service is not practicable; (iii) the agency or the Service lacks authority under the Act or regulations; or (iv) sufficient information is not available to make an accurate determination. (2) Original services. A request for original services shall be dismissed if a reinspection, review of weighing, appeal inspection, or Board appeal inspection has been performed on the same lot at the same specified service point within 5 business days. (3) Reinspection, appeal inspection, or Board appeal inspection services. A request for a reinspection, appeal inspection, or Board appeal inspection service shall be dismissed when: (i) The kind and scope are different from the kind and scope of the last inspection service; (ii) The condition of the grain has undergone a material change; (iii) The request specifies a representative file sample and a representative file sample is not available, (iv) The applicant requests that a new sample be obtained and a new sample cannot be obtained; or (v) The service cannot be performed within 5 business days of the date of the last inspection date. (4) Review of weighing services. A request for review of weighing services shall be dismissed when the request (i) is filed before the weighing results have been released, or (ii) is filed more than 90 calendar days after the date of the original service. (b) Procedure for dismissal. When an agency or the Service proposes to dismiss a request for official services, the applicant shall be notified of the proposed action. The applicant will then be afforded reasonable time to take corrective action or to demonstrate there is no basis for the dismissal. If the agency or the Service determines that corrective action has not been adequate, the applicant will be notified again of the decision to dismiss the request for service, and any results of official services shall not be released." 7:7:7.1.2.8.1.0.14.30,7,Agriculture,VIII,A,800,PART 800—GENERAL REGULATIONS,,,,§ 800.49 Conditional withholding of official services.,AMS,,,"[49 FR 30915, Aug. 2, 1984]","(a) Conditional withholding. An agency or the Service shall conditionally withhold requests for official services when an applicant fails to meet any requirement prescribed in § 800.46. (b) Procedure and withholding. When an agency or the Service proposes to conditionally withhold official services, the applicant shall be notified of the reason for the proposed action. The applicant will then be afforded reasonable time to take corrective action or to show that there is no basis for withholding services. If the agency or the Service determines that corrective action has not been adequate, the applicant will be notified. Any results of official services shall not be released when a request for service is withheld." 7:7:7.1.2.8.1.0.14.31,7,Agriculture,VIII,A,800,PART 800—GENERAL REGULATIONS,,,,§ 800.50 Refusal of official services and civil penalties.,AMS,,,"[45 FR 15810, Mar. 11, 1980, as amended at 51 FR 12830, Apr. 16, 1986, 75 FR 17560, Apr. 7, 2010]]","(a) Grounds for refusal. Any or all services available to an applicant under the Act may be refused, either temporarily or indefinitely, by the Service for causes prescribed in section 10(a) of the Act. Such refusal by the Service may be restricted to the particular facility or applicant (if not a facility) found in violation or to a particular type of service, as the facts may warrant. Such action may be in addition to, or in lieu of, criminal penalties or other remedial action authorized by the Act. (b) Provision and procedure for summary refusal. The Service may, without first affording the applicant (hereafter in this section “respondent”) a hearing, refuse to provide official inspection and Class X or Y weighing services pending final determination of the proceeding whenever the Service has reason to believe there is cause, as prescribed in section 10 of the Act, for refusing such official services and considers such action to be in the best interest of the official services system under the Act: Provided that within 7 days after refusal of such service, the Service shall afford the respondent an opportunity for a hearing as provided under paragraph (c)(2) of this section. Pending final determination, the Service may terminate the temporary refusal if alternative managerial, staffing, financial, or operational arrangements satisfactory to the Service can be and are made by the respondent. (c) Procedure for other than summary refusal. Except as provided in paragraph (b) of this section, before the Service refuses to provide official services the respondent shall be (1) notified of the services that are to be refused, the locations at which and the time period for which service will be refused, and the reasons for the refusal; and (2) afforded an opportunity for a hearing in accordance with the provisions of the Rules of Practice Governing Formal Adjudicatory Proceedings Instituted by the Secretary Under Various Statutes (7 CFR 1.130 et seq. ). At the discretion of the Service, prior to initiation of formal adjudicatory proceedings, the respondent may be given an opportunity to express his or her views on the action proposed by the Service in an informal conference before the Administrator of the Service. If, as a result of such an informal conference, the Service and the respondent enter into a consent agreement, no formal adjudicatory proceedings shall be initiated. (d) Assessment of civil penalties. Any person who has knowingly committed any violation of section 13 of the Act or has been convicted of any violation of other Federal law with respect to the handling, weighing, or official inspection of grain may be assessed a civil penalty not to exceed the amount specified at § 3.91(b)(6)(viii) of this title for each such violation as the Administrator determines is appropriate to effect compliance with the Act. Such action may be in addition to, or in lieu of, criminal penalties under section 14 of the Act, or in addition to, or in lieu of, the refusal of official services authorized by the Act. (e) Provisions for civil penalty hearings. Before a civil penalty is assessed against any person, such person shall be afforded an opportunity for a hearing as provided under paragraph (c)(2) of this section. (f) Collection of civil penalties. Upon failure to pay the civil penalty, the Service may request the Attorney General to file civil action to collect the penalty in a court of appropriate jurisdiction." 7:7:7.1.2.8.1.0.14.32,7,Agriculture,VIII,A,800,PART 800—GENERAL REGULATIONS,,,,"§ 800.51 Expenses of agency, field office, or Board of Appeals and Review.",AMS,,,"[49 FR 30915, Aug. 2, 1984]","For any request that has been dismissed or withdrawn under § 800.47, § 800.48, or § 800.49, respectively, each applicant shall pay expenses incurred by the agency or the Service." 7:7:7.1.2.8.1.0.14.33,7,Agriculture,VIII,A,800,PART 800—GENERAL REGULATIONS,,,,§ 800.52 Official services not to be denied.,AMS,,,,"Subject to the provisions of §§ 800.48, 800.49, and 800.50, no person entitled to official services under the Act shall be denied or deprived of the right thereto by reason of any rule, regulation, bylaw, or custom of any market, board of trade, chamber of commerce, exchange, inspection department, or similar organization; or by any contract, agreement, or other understanding." 7:7:7.1.2.8.1.0.15.34,7,Agriculture,VIII,A,800,PART 800—GENERAL REGULATIONS,,,,§ 800.55 Descriptions by grade.,AMS,,,"[50 FR 9982, Mar. 13, 1985]","(a) General. In any sale, offer for sale, or consignment for sale, which involves the shipment of grain in interstate or foreign commerce, the description of grain, as being of a grade in any advertising, price quotation, other negotiation of sale, contract of sale, invoice, bill of lading, other document, or description on bags or other containers of the grain, is prohibited if such description is other than by an official grade designation, with or without additional information as to specified factors. An official grade designation contains any of the following: The term “U.S.,” the numerals 1 through 5, the term “Sample grade,” or the name of a subclass or a special grade of grain specified in the Official United States Standards for Grain. (b) Proprietary brand names or trademarks. A description of grain by a proprietary brand name or a trademark that does not resemble an official grade designation will not be considered to be a description by grade; but a description by a proprietary brand name or trademark that contains singly or in combination any of the terms referenced in paragraph (a) of this section shall be considered to resemble an official grade designation. (c) Use of one or more factor designations. In interstate commerce, a description of grain by the use of one or more grade factor designations which appear in the Official United States Standards for Grain or by other criteria will not be considered to be a description by grade. (d) False or misleading descriptions. In any sale, offer for sale, or consignment for sale of any grain which involves the shipment of grain from the United States to any place outside thereof, knowingly using a false or misleading description of grain by official grade designation, or other description is prohibited." 7:7:7.1.2.8.1.0.15.35,7,Agriculture,VIII,A,800,PART 800—GENERAL REGULATIONS,,,,§ 800.56 Requirements on descriptions.,AMS,,,"[50 FR 9982, Mar. 13, 1985]","Section 13 of the Act contains certain prohibitions with respect to the use of official grade designations, official marks, and other representations with respect to grain. (a) The use of an official grade designation, with or without factor information, or of official criteria information, or of the term “official grain standards,” shall not, without additional information, be considered to be a representation that the grain was officially inspected. (b) The use of any symbol or term listed as an official mark, at § 800.0(b)(68), with respect to grain shall be considered to be a representation of official service under the Act: Provided however, that the use of the official marks “official certificate;” “officially inspected;” “official inspection;” “officially weighed;” “official weight;” and “official weighing” shall not be considered to be a representation of official service under the Act if it is clearly shown that the activity occurred under the U.S. Warehouse Act (7 U.S.C. 241 et seq. ): Provided further, that the use of the official mark “officially tested” with respect to grain inspection and weighing equipment shall not be considered to be a representation of testing under the Act if it is clearly shown that the equipment was tested under a State statute." 7:7:7.1.2.8.1.0.16.36,7,Agriculture,VIII,A,800,PART 800—GENERAL REGULATIONS,,,,§ 800.60 Deceptive actions and practices.,AMS,,,"[48 FR 17330, Apr. 22, 1983, as amended at 48 FR 44453, Sept. 29, 1983; 54 FR 5924, Feb. 7, 1989]","In the absence of prior adequate notice to appropriate official personnel, any action or practice, including the loading, weighing, handling, or sampling of grain that knowingly causes or is an attempt to cause the issuance by official personnel of a false or incorrect official certificate or other official form, is deemed to be deceptive and, as such, is a violation of section 13(a)(3) of the Act. For the purposes of this paragraph, adequate notice is written or oral notice given to an agency or the Service, as applicable, before official personnel begin to perform official inspection or weighing services. If oral notice is given, it must be confirmed in writing within 2 business days. To be adequate, the notice must explain the nature and extent of the action or practice in question and must identify the grain, stowage container, equipment, facility, and the official personnel actually or potentially involved." 7:7:7.1.2.8.1.0.16.37,7,Agriculture,VIII,A,800,PART 800—GENERAL REGULATIONS,,,,§ 800.61 Prohibited grain handling practices.,AMS,,,"[52 FR 24437, June 30, 1987, as amended at 59 FR 52077, Oct. 14, 1994]","(a) Definitions. For the purpose of this section, dockage and foreign material in grain shall be: (1) Defined for export elevators at export port locations as set forth in 7 CFR part 810 and as dust removed from grain and collected in a bin/container and as dust settling on floors, equipment, and other areas, commonly referred to as dust sweepings; and (2) Defined for other than export elevators as set forth in 7 CFR part 810. (b) Prohibited practices. Except as permitted in paragraphs (c) and (d) of this section, no person shall: (1) Recombine or add dockage or foreign material to any grain, or (2) Blend different kinds of grain except when such blending will result in grain being designated as Mixed grain in accordance with subpart E of the Official United States Standards for Grain. (3) Add water to grain for purposes other than milling, malting, or similar processing operations. (c) Exemption. (1) The Administrator may grant exemptions from paragraph (b) of this section for grain shipments sent directly to a domestic end-user or processor. Requests for exemptions shall be submitted by grain handlers to the Service through the domestic end-users or processors or their representatives. (2) Grain sold under an exemption shall be consumed or processed into a product(s) by the purchaser and not resold into the grain market. (3) Products or byproducts from grain sold under an exemption shall not be blended with or added to grain in commercial channels, except for vegetable oil which may be used as a dust suppressant in accordance with (d)(4) of this section. (d) Exceptions. Paragraph (b) shall not be construed as prohibiting the following grain handling practices. Compliance with paragraphs (d)(1) through (d)(6) of this section does not excuse compliance with applicable Federal, State, and local laws. (1) Blending. Grain of the same kind, as defined by the Official United States Standards for Grain, may be blended to adjust quality. Broken corn or broken kernels may be recombined or added to whole grain of the same kind provided that no foreign material or dockage has been added to the broken corn or broken kernels. (2) Insect and fungi control. Grain may be treated to control insects and fungi. Elevators, other grain handlers, and their agents are responsible for the proper use and applications of insecticides and fungicides. Sections 800.88 and 800.96 include additional requirements for grain that is officially inspected and weighed. (3) Marketing dockage and foreign material. Dockage and foreign material may be marketed separately. (4) Dust suppressants. Grain may be treated with an additive, other than water, to suppress dust during handling. Elevators, other grain handlers, and their agents are responsible for the proper use and application of dust suppressants. Sections 800.88 and 800.96 include additional requirements for grain that is officially inspected and weighed. (5) Identification. Confetti or similar material may be added to grain for identification purposes. Elevators, other grain handlers, and their agents are responsible for the proper use and application of such materials. Sections 800.88 and 800.96 include additional requirements for grain that is officially inspected or weighed. (6) Export loading facilities. Between May 1, 1987, and December 31, 1987, export elevators at export port locations may recombine dockage and foreign material, but not dust, with grain provided such recombination occurs during the loading of a vessel with the intended purpose of ensuring uniformity of dockage and foreign material in the cargo." 7:7:7.1.2.8.1.0.17.38,7,Agriculture,VIII,A,800,PART 800—GENERAL REGULATIONS,,,,§ 800.70 Fees for official services performed by agencies.,AMS,,,"[45 FR 15810, Mar. 11, 1980; 45 FR 55119, Aug. 18, 1980, as amended at 48 FR 44453, Sept. 29, 1983; 50 FR 30131, July 24, 1985]","(a) Assessment and use of fees. (1) Fees assessed by an agency for official inspection and Class X or Class Y weighing services or testing of inspection equipment shall be reasonable and nondiscriminatory. (2) In the case of a State or local governmental agency, fees shall not be used for any purpose other than to finance the cost of the official inspection and Class X or Class Y weighing service and inspection equipment testing service performed by the agency or the cost of other closely related programs administered by the agency. (b) Approval required —(1) Restriction. Only fees that meet the requirements stated in this section and are approved by the Service as reasonable and nondiscriminatory may be charged by an agency. (2) Exceptions. For good cause shown by an agency, the Administrator may grant case-by-case exceptions to the requirements in this section, provided that a determination is made that the agency fees would be reasonable and nondiscriminatory. (c) Reasonable fees. In determining if an agency's fees are reasonable, the Service will consider whether the fees: (1) Cover the estimated total cost to the agency of (i) Official inspection services, (ii) Class X or Class Y weighing services, (iii) Inspection equipment testing services, and (iv) Related supervision and monitoring activities performed by the agency; (2) Are reasonably consistent with fees assessed by adjacent agencies for similar services; (3) Are assessed on the basis of the average cost of performing the same or similar services at all locations served by the agency; and (4) Are supported by sufficient information which shows how the fees were developed. (d) Nondiscriminatory fees. In determining if fees are nondiscriminatory, the Service will consider whether the fees are collected from all applicants for official service in accordance with the approved fee schedule. Charges for time and travel incurred in providing service at a location away from a specified service point shall be assessed in accordance with the approved fee schedule. (e) Schedule of fees to be established. (1) Each agency shall establish a schedule of fees for official services which the agency is delegated or designated the authority to perform. The schedule shall be in a standard format in accordance with the instructions. Such schedules may include fees for nonofficial services provided by the agency, but they shall be clearly identified and will not be subject to approval by the Service. (2) The schedule shall be published and made available by the agency to all users of its services. (f) Request for approval of fees —(1) Time requirement. A request for approval of a new or revised fee shall be submitted to the Service not less than 60 days in advance of the proposed effective date for the fee. Failure to submit a request within the prescribed time period may be considered grounds for postponment or denial of the request. (2) Contents of request. Each request shall show (i) the present fee, if any, and the proposed fee, together with data showing in detail how the fee was developed, and (ii) the proposed effective date. (g) Review of request —(1) Approval action. If upon review the Service finds that the request and supporting data justify the new or revised fee, the request will be marked “approved” and returned to the agency. (2) Denial action. If the Service finds that the request and supporting data do not justify the new or revised fee, approval of the request will be withheld pending receipt of any additional supporting data which the agency has to offer. If the data are not submitted within a reasonable period, the request shall be denied. In the case of a denial of a request, the agency shall be notified of the reason for denial." 7:7:7.1.2.8.1.0.17.39,7,Agriculture,VIII,A,800,PART 800—GENERAL REGULATIONS,,,,§ 800.71 Fees assessed by the Service.,AMS,,,"[90 FR 534, Jan. 6, 2025]","(a) Official inspection and weighing services. The fees described for Direct Service in paragraph (a)(1) of this section apply to official inspection and weighing services performed by the Service in the U.S. and Canada. The fees described for Supervision in paragraph (a)(2) of this section apply to official domestic inspection and weighing services performed by delegated States and designated agencies, including land carrier shipments to Canada and Mexico. The fees charged to delegated States by the Service are set forth in the State's Delegation of Authority document. Failure of a delegated State or designated agency to pay the appropriate fees to the Service within 30 days after becoming due will result in an automatic termination of the delegation or designation. The delegation or designation may be reinstated by the Service if fees that are due, plus interest and any further expenses incurred by the Service because of the termination, are paid within 60 days of the termination. (1) Direct Service—Fees for official inspection and weighing services performed by the Service in the United States and Canada. For each calendar year, the Service will calculate Direct Service fees as provided in paragraphs (b) and (c) of this section. The Service will publish a notice in the Federal Register and post Direct Service fees on its public website. (2) Supervision—Fees for supervision of official inspection and weighing services performed by delegated States and designated agencies in the United States. The Service will assess a Supervision fee per metric ton of domestic U.S. grain shipments inspected or weighed, or both, including land carrier shipments to Canada and Mexico. For each calendar year, the Service will calculate Supervision fees as provided in paragraph (d) of this section. The Service will publish a notice in the Federal Register and post the Supervision fees on its public website. (b) Annual review of tonnage fees. For each calendar year, the Service will review and adjust fees included in this section and publish fees each year according to the following: (1) Tonnage fees. Tonnage fees for Direct Service in paragraph (a)(1) of this section will consist of the national tonnage fee and local tonnage fees and the Service will calculate and round the fee to the nearest $0.001 per metric ton. All outbound grain officially inspected and/or weighed by the Field Offices will be assessed the national tonnage fee plus the appropriate local tonnage fee. Export grain officially inspected and/or weighed by delegated States and official agencies, excluding land carrier shipments to Canada and Mexico, will be assessed the national tonnage fee only. The fees will be set according to the following: (i) National tonnage fee. The national tonnage fee is the national program administrative costs for the previous fiscal year divided by the average yearly tons of export grain officially inspected and/or weighed by delegated States and designated agencies, excluding land carrier shipments to Canada and Mexico, and outbound grain officially inspected and/or weighed by the Service, during the previous 5 fiscal years. (ii) Local tonnage fee. The local tonnage fee is the Field Office administrative costs for the previous fiscal year divided by the average yearly tons of outbound grain officially inspected and/or weighed by the Field Office during the previous 5 fiscal years. The local tonnage fee is calculated individually for each Field Office. (2) [Reserved] (c) Annual review of hourly and unit fees. The Service will calculate the rate for program services, per hour per program employee using the following formulas: (1) Regular rate. The total direct pay of program personnel performing grading, weighing, laboratory services, and equipment testing divided by the total direct hours for the previous year, which is then multiplied by the next year's percentage cost-of-living increase, plus the benefits rate, plus the operating rate, plus the allowance for bad debt rate. If applicable, travel expenses will be added to the cost of providing the service through the operating rate or the travel will be billed separately. (2) Overtime rate. The total direct pay of program personnel performing grading, weighing, laboratory services, and equipment testing divided by the total direct hours for the previous year, which is then multiplied by the next year's percentage cost-of-living increase and then multiplied by 1.5, plus the benefits rate, plus the operating rate, plus the allowance for bad debt rate. If applicable, travel expenses will be added to the cost of providing the service through the operating rate or the travel will be billed separately. (3) Holiday rate. The total direct pay of program personnel performing grading, weighing, laboratory services, and equipment testing divided by the total direct hours for the previous year, which is then multiplied by the next year's percentage cost-of-living increase and then multiplied by 2, plus the benefits rate, plus the operating rate, plus the allowance for bad debt rate. If applicable, travel expenses will be added to the cost of providing the service through the operating rate or the travel will be billed separately. (4) Benefits rate, operating rate, and allowance for bad debt rate. For each calendar year, based on previous fiscal year costs, the Service will calculate the benefits rate, operating rate, and allowance for bad debt rate as follows: (i) Benefits rate. The total direct benefits costs of program personnel performing grading, weighing, laboratory services, and equipment testing divided by the total hours (regular, overtime, and holiday) worked, which is then multiplied by the next calendar year's percentage cost-of-living increase. (ii) Operating rate. The total operating costs of program personnel performing grading, weighing, laboratory services, and equipment testing divided by total hours (regular, overtime, and holiday) worked, which is then multiplied by the percentage of inflation. (iii) Allowance for bad debt rate. The total allowance for bad debt for personnel performing grading, weighing, laboratory services, and equipment testing divided by total hours (regular, overtime, and holiday) worked. (5) Cost of living and inflation factors. The Service will use the most recent economic factors released by the Office of Management and Budget for budget development purposes to derive the cost-of-living expenses and percentage of inflation factors used in the formulas in this section. (6) Operating reserve adjustment. The Service will review the operating reserve at the end of each fiscal year and adjust the fees as needed to ensure an operating reserve of 3 to 6 months of expenses. This adjustment is included in the calculation for operating cost. (d) Annual review of Supervision fees. Fees for Supervision in paragraph (a)(2) of this section will be set according to the following: (1) Supervision tonnage fee. The supervision tonnage fee is the sum of the prior fiscal year program costs plus an operating reserve adjustment divided by the average yearly tons of domestic U.S. grain shipments inspected or weighed, or both, including land carrier shipments to Canada and Mexico, during the previous 5 fiscal years. If the calculated value is zero or a negative value, the Service will suspend the collection of supervision tonnage fees for 1 calendar year. (2) Operating reserve adjustment. The operating reserve adjustment is the supervision program costs for the previous fiscal year divided by 2, less the end of previous fiscal year operating reserve balance. (e) Periodic review. The Service will periodically review and adjust all Direct Service and Supervision fees in paragraphs (a)(1) and (2) of this section, respectively, as necessary to ensure they reflect the true cost of providing and supervising official service. This process will incorporate any fee adjustments from paragraphs (b) through (d) of this section. (f) Miscellaneous fees for other services. For each calendar year, the Service will review fees included in this section and publish fees in the Federal Register and on its public website. (1) Registration certificates and renewals. The fee for registration certificates and renewals will be published annually in the Federal Register and on the Service's public website, and the Service will calculate the fee using the noncontract hourly rate published pursuant to paragraph (a)(1) of this section multiplied by 5. If you operate a business that buys, handles, weighs, or transports grain for sale in foreign commerce, or you are in a control relationship with respect to a business that buys, handles, weighs, or transports grain for sale in interstate commerce, you must complete an application and pay the published fee. (2) Designation amendments. The fee for amending designations will be published annually in the Federal Register and on the Service's public website. The Service will calculate the fee using the cost of publication plus 1 hour at the noncontract hourly rate. If submitting an application to amend a designation, the published fee must be paid."