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| 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 |
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| 15:15:1.2.2.1.1.0.5.1 | 15 | Commerce and Foreign Trade | II | A | 200 | PART 200—POLICIES, SERVICES, PROCEDURES, AND FEES | § 200.100 Statutory functions. | NIST | (a) The National Institute of Standards & Technology (NIST) has been assigned the following functions (15 U.S.C. 271 et seq. ): (1) The custody, maintenance, and development of the national standards of measurement, and the provision of means and methods for making measurements consistent with those standards, including the comparison of standards used in scientific investigations, engineering, manufacturing, commerce, and educational institutions with the standards adopted or recognized by the Government. (2) The determination of physical constants and properties of materials when such data are of great importance to scientific or manufacturing interests and are not to be obtained with sufficient accuracy elsewhere. (3) The development of methods for testing materials, mechanisms, and structures, and the testing of materials, supplies, and equipment, including items purchased for use of Government departments and independent establishments. (4) Cooperation with other governmental agencies and with private organizations in the establishment of standard practices, incorporated in codes and specifications. (5) Advisory service to Government agencies on scientific and technical problems. (6) Invention and development of devices to serve special needs of the Government. (b) The calibration and testing activities of NIST stem from the functions in paragraphs (a) (1) and (3) of this section. NIST provides the central basis within the United States for a complete and consistent system of measurement; coordinates that system, and the measurement systems of other nations; and furnishes essential services leading to accurate and uniform physical measurements throughout this Nation's scientific community, industry, and commerce. (c) The provision of standard reference materials for sale to the public is assigned to the Office of Standard Reference Materials of the National Measurement Laboratory, NIST. That Office evaluates the requirements of science and industry for carefully characterized reference materials, st… | ||||||
| 15:15:1.2.2.1.1.0.5.10 | 15 | Commerce and Foreign Trade | II | A | 200 | PART 200—POLICIES, SERVICES, PROCEDURES, AND FEES | § 200.109 Shipping, insurance, and risk of loss. | NIST | (a) Shipment of apparatus to NIST for calibration or other test should be made only after the customer has accepted the estimate of cost and the tentative scheduling. Repairs and adjustments on apparatus submitted should be attended to by the owner, since NIST will not undertake them except by special arrangement. Apparatus not in good condition will not be calibrated. If defects are found after calibration has begun, the effort may be terminated, a report issued summarizing such information as has been found, and a fee charged in accordance with the amount of work done. (b) The customer should pack apparatus sent to NIST so as to minimize the likelihood of damage in shipment and handling. Suggestions on packing and shipping are made in some sections of SP 250. In every case, the sender should consider the nature of the apparatus, pack it accordingly, and clearly label shipments containing fragile instruments or materials, such as glass and the like. (c) To minimize damage during shipment resulting from inadequate packing, the use of strong reusable containers is recommended. As an aid in preventing loss of such containers, the customer's name should be legibly and permanently marked on the outside. In order to prolong the container's use the notation “REUSABLE CONTAINER, DO NOT DESTROY” should be marked on the outside. (d) Shipping and insurance coverage instructions should be clearly and legibly shown on the purchase order for the calibration or test. The customer must pay shipping charges to and from NIST; shipments from NIST will be made collect. The method of return transportation should be stated, and it is recommeded that return shipments be insured, since NIST will not assume liability for their loss or damage. For long-distance shipping it is found that air express and air freight provide an advantage in reduction of time in transit. If return shipment by parcel post is requested or is a suitable mode of transportation, shipments will be prepaid by NIST, but without covering insurance. When no shippin… | ||||||
| 15:15:1.2.2.1.1.0.5.11 | 15 | Commerce and Foreign Trade | II | A | 200 | PART 200—POLICIES, SERVICES, PROCEDURES, AND FEES | § 200.110 Priorities and time of completion. | NIST | Schedule work assignments for calibrations and other tests will generally be made in the order in which confirmed requests are received. However, Government work may be given priority. On the regular services, the workload is usually such that the turn-around interval, between the date a customer's apparatus is received and the date it is prepared for return shipment, will be not more than 45 days. Some types of instruments may require considerably longer, particularly if their abnormal behavior requires reruns to check reliability. The customer who can spare the instrument for only a short time can usually arrange by letter or telephone call for shipping it to NIST just as the assigned starting date approaches. A notice will be sent acknowledging receipt of the customer's standard and/or purchase order. If both a confirmed purchase order (or equivalent) and the apparatus have been received, estimates of the completion date and the calibration fee will be sent upon request. | ||||||
| 15:15:1.2.2.1.1.0.5.12 | 15 | Commerce and Foreign Trade | II | A | 200 | PART 200—POLICIES, SERVICES, PROCEDURES, AND FEES | § 200.111 Witnessing of operations. | NIST | NIST welcomes scientists and engineers who may wish to visit its laboratories and discuss its methods. Ordinarily visitors will not be permitted to witness the actual carrying out of highly precise measurements because their presence introduces distraction that may lead to errors or delays. This policy may be waived in those cases where NIST determines that the visitor can be of service in setting up apparatus of a new or unusual nature, in the case of referee tests, or in other cases in which the legal validity of the result may require the presence of duly authorized witnesses. | ||||||
| 15:15:1.2.2.1.1.0.5.13 | 15 | Commerce and Foreign Trade | II | A | 200 | PART 200—POLICIES, SERVICES, PROCEDURES, AND FEES | § 200.112 Reports. | NIST | (a) Results of calibrations and other tests are issued to the customer as formal reports entitled, “National Institute of Standards & Technology Report of Calibration,” “National Institute of Standards & Technology Report of Test,” or “National Institute of Standards & Technology Report of Analysis,” as appropriate. Copies are not supplied to other parties except under applicable Federal law. Whenever formal certification is required by law, or to meet special conditions adjudged by NIST to warrant it, a letter will be provided certifying that the particular item was received and calibrated or tested, and identifying the report containing the results. (b) NIST reports of calibration generally include in sentence form a statement of the uncertainty attached to the numerical values reported. Limits of uncertainty usually comprise an estimate of systematic error plus a value of imprecision. Details on how these estimates are arrived at are in many cases included in the calibration report. Additional information may be found in SP 250. (c) The NIST practice is to express data given in calibration or test reports in the SI or International System of Units. The International System of Units (SI) was defined and given official status by the 11th General Conference of Weights and Measures, 1960. A complete listing of SI units is presented in detail in NIST SP 330. The NIST will express data in SI units unless this makes communication excessively complicated. For example, commercial gage designations, commonly used items identified by nominal dimensions, or other commercial nomenclatures or devices (such as drill sizes, or commercial standards for weights and measures) expressed in customary units are an exception from this practice. However, even in such instances, when practical and meaningful, SI and customary units may be given in parallel. Users of NIST calibration services may specify the units to be used in the calibration, especially for commercial devices and standards using customary units or units having some… | ||||||
| 15:15:1.2.2.1.1.0.5.14 | 15 | Commerce and Foreign Trade | II | A | 200 | PART 200—POLICIES, SERVICES, PROCEDURES, AND FEES | § 200.113 Use of results or reports. | NIST | (a) As the national standards laboratory of the United States, NIST maintains and establishes the primary standards from which measurements in science and industry ultimately derive. It is therefore sometimes desirable for manufacturers or users of measurement standards to make appropriate reference to the relationship of their calibrations to NIST calibrations. The following considerations must be borne in mind, and shall be understood as constituting an agreement on the part of the NIST customer to be bound thereby in making reference to NIST calibration and test reports. (b) The results of calibrations and tests performed by NIST are intended solely for the use of the organization requesting them, and apply only to a particular device or specimen at the time of its test. The results shall not be used to indicate or imply that they are applicable to other similar items. In addition, such results must not be used to indicate or imply that NIST approves, recommends, or endorses the manufacturer, the supplier, or the user of such devices or specimens, or that NIST in any way “guarantees” the later performance of items after calibration or test. (c) NIST declares it to be in the national interest that it maintain an impartial position with respect to any commercial product. Advertising the findings on a single instrument could be misinterpreted as an indication of performance of other instruments of identical or similar type. There will be no objection, however, to a statement that the manufacturer's primary standards have been periodically calibrated by NIST, if this is actually the case, or that the customer might arrange to have NIST calibrate the item purchased from the manufacturer. (d) NIST does not approve, recommend, or endorse any proprietary product or proprietary material. No reference shall be made to NIST, or to reports or results furnished by NIST in any advertising or sales promotion which would indicate or imply that NIST approves, recommends, or endorses any proprietary product or proprietary ma… | ||||||
| 15:15:1.2.2.1.1.0.5.15 | 15 | Commerce and Foreign Trade | II | A | 200 | PART 200—POLICIES, SERVICES, PROCEDURES, AND FEES | § 200.114 Fees and bills. | NIST | (a) In accordance with 15 U.S.C. 271 et seq., fees are charged for all measurement services performed by NIST, unless waived by the Director, or the Director's designee, when deemed to be in the interest of the Government. The above-mentioned statutes authorize the issuance from time to time of appropriate regulations regarding the payment of fees, the limits of tolerance on standards submitted for verification, and related matters. (b) The minimum fee for any service request accepted by NIST is $10, unless otherwise indicated in SP 250. If apparatus is returned without testing, a minimum charge of $10 may be made to cover handling. Charges commensurate with the work performed will be assessed for calibrations which cannot be completed because of faulty operation of the customer's device. Fees for calibrations or tests include the cost of preparation of an NIST report. Remittances should be made payable to the National Institute of Standards & Technology. | ||||||
| 15:15:1.2.2.1.1.0.5.16 | 15 | Commerce and Foreign Trade | II | A | 200 | PART 200—POLICIES, SERVICES, PROCEDURES, AND FEES | § 200.115 Description of services and list of fees, incorporation by reference. | NIST | (a) NIST Special Publication 250, “Calibration and Related Measurement Services of the National Institute of Standards & Technology” is hereby incorporated by reference, pursuant to 5 U.S.C. 552(a)(1) and 1 CFR Part 51. SP 250 states the authority under which NIST performs various types of measurement services including calibrations and tests and charges fees therefor, states the general conditions under which the public may secure such services, decribes these services in considerable detail, and lists the fees to be charged, and sets out the instructions for requesting them in an appendix which is reviewed, revised and reissued semi-annually (December and June). The Director, Office of the Federal Register, approved the incorporation by reference on December 28, 1967. (b) SP 250 is available at the following places: (1) Superintendent of Documents, Government Printing Office, Washington, DC 20402. (2) Technical Information and Publications Division, National Institute of Standards & Technology, Washington, DC 20234. (3) District Offices of the U.S. Department of Commerce. (4) Federal Depository Libraries. (c) Revisions of SP 250 will be issued from time to time by the National Institute of Standards & Technology, Washington, DC 20234. (d) Further information concerning policies, procedures, services, and fees may be obtained by writing the Office of Measurement Services, National Institute of Standards & Technology, Washington, DC 20234. | ||||||
| 15:15:1.2.2.1.1.0.5.2 | 15 | Commerce and Foreign Trade | II | A | 200 | PART 200—POLICIES, SERVICES, PROCEDURES, AND FEES | § 200.101 Measurement research. | NIST | (a) The NIST staff continually reviews the advances in science and the trends in technology, examines the measurement potentialities of newly discovered physical phenomena, and uses these to devise and improve standards, measuring devices, and measurement techniques. As new requirements appear, there are continual shifts of program emphasis to meet the most urgent needs for the measurement of additional quantities, extended ranges, or improved accuracies. (b) The basic research and development activities of NIST are primarily funded by direct appropriations, and are aimed at meeting broad general needs. NIST may also undertake investigations or developments to meet some specialized physical measurement problem of another Government agency, industrial group, or manufacturing firm, using funds supplied by the requesting organization. | ||||||
| 15:15:1.2.2.1.1.0.5.3 | 15 | Commerce and Foreign Trade | II | A | 200 | PART 200—POLICIES, SERVICES, PROCEDURES, AND FEES | § 200.102 Types of calibration and test services. | NIST | (a) NIST has developed instrumentation and techniques for realizing standards for the seven base units of the International System of Units, as agreed upon by the General Conference of Weights and Measures. Reference standards have been established not only for these seven base units, but also for many derived quantities and their multiples and submultiples. Such reference standards, or equivalent working standards, are used to calibrate laboratory and plant standards for other organizations. Accuracy is maintained by stability checks, by comparison with the standards of other national and international laboratories, and by the exploration of alternative techniques as a means of reducing possible systematic error. (b) Calibrations for many types of instruments and ranges of physical quantities are described in the NIST Special Publication 250 (SP 250). (See § 200.115 for details relating to the description of service items and listing of fees.) (c) In recent years NIST has offered to the public new measurement services called measurement assurance programs. These programs are designed for laboratories whose measurement process involves the calibration of other standards. A measurement assurance program is a measurement quality control process. By use of carefully designed redundant measurements and measurements made on NIST transport standards a total uncertainty of the laboratories measurement process can be determined by NIST. The results of these tests are then reported to the customer as uncertainties of the customer's measurements relative to national standards. (d) Special measurements not listed in SP 250 may be made upon request. These might involve unusual physical quantities, upper or lower extremes of range, higher levels of accuracy, fast response speeds, short durations, broader ranges of associated parameters, or special environmental conditions. Such inquiries should describe clearly the measurement desired. Indication of the scientific or economic basis for the requirements to be satisfied will… | ||||||
| 15:15:1.2.2.1.1.0.5.4 | 15 | Commerce and Foreign Trade | II | A | 200 | PART 200—POLICIES, SERVICES, PROCEDURES, AND FEES | § 200.103 Consulting and advisory services. | NIST | (a) In areas of its special competence, NIST offers consulting and advisory services on various problems related to measurement, e.g., details of design and construction, operational aspects, unusual or extreme conditions, methods of statistical control of the measurement process, automated acquisition of laboratory data, and data reduction and analysis by computer. Brief consultation may be obtained at no charge; the fee for extended effort will be based upon actual costs incurred. The services outlined in this paragraph do not include services in connection with legal proceedings not involving the United States as a named party, nor to testimony or the production of data, information, or records in such legal proceedings which is governed by the policies and procedures set forth in Subchapter H, Chapter II, Part 275, of this title. (b) To enhance the competence of standards laboratory personnel, NIST conducts at irregular intervals several group seminars on the precision measurement of specific types of physical quantities, offering the opportunity of laboratory observation and informal discussion. A brochure describing the current series of seminars can be obtained by writing the Office of Measurement Services, National Institute of Standards & Technology, Washington, DC 20234. | ||||||
| 15:15:1.2.2.1.1.0.5.5 | 15 | Commerce and Foreign Trade | II | A | 200 | PART 200—POLICIES, SERVICES, PROCEDURES, AND FEES | § 200.104 Standard reference materials. | NIST | Often the performance of a device or structure can be evaluated at the user's laboratory by comparing its response to unknown materials with its response to a stable, homogeneous reference specimen which has been well-characterized with regard to the physical or chemical property being measured. For information regarding carefully characterized materials see Subchapter B, Chapter II, Part 230, of this title. The Office of Standard Reference Materials in the NIST National Measurement Laboratory administers a program to provide many types of well-characterized materials that are needed to calibrate a measurement system or to produce scientific data that can be readily referred to a common base. NIST SP 260 is a catalog of Standard Reference Materials available from NIST. | ||||||
| 15:15:1.2.2.1.1.0.5.6 | 15 | Commerce and Foreign Trade | II | A | 200 | PART 200—POLICIES, SERVICES, PROCEDURES, AND FEES | § 200.105 Standard reference data. | NIST | Data on the physical and chemical properties of the large variety of substances used in science and technology need to be compiled and evaluated for application in research, development, engineering design, and commerce. The Office of Standard Reference Data (OSRD) in the NIST National Measurement Laboratory provides coordination of and access to a number of governmental and nongovernmental data centers throughout this country and the world which are responsive to user needs for data. The OSRD's present program is assembled under a series of tasks which include data for application in energy, environment and health, industrial process design, materials durability, and resource recovery. The subject data are disseminated as hard-copy information in the Journal of Physical and Chemical Reference Data, published jointly with the American Chemical Society and the American Institute of Physics, in the National Standard Reference Data System reports as the NSRDS-NIST series, and as NIST special reports. Magnetic tapes of data on selected topics are also issued through the OSRD and the National Technical Information Service. A newsletter, “Reference Data Report,” is issued bimonthly describing current activities. Information concerning the above is available upon request from the OSRD. | ||||||
| 15:15:1.2.2.1.1.0.5.7 | 15 | Commerce and Foreign Trade | II | A | 200 | PART 200—POLICIES, SERVICES, PROCEDURES, AND FEES | § 200.106 Publications. | NIST | Publications provide the primary means of communicating the results of the NIST programs and services to its varied technical audiences, as well as to the general public. NIST issues some fifteen categories of publications including three periodicals, ten non-periodicals series, interagency reports, and papers in the journals and books of professional organizations, technological associations, and commercial publications. The calibration services, standard reference materials and related measurement services along with changes and fees are published in two Special Publications (SP's) and their supplements. These are SP 250 “Calibration and Related Measurement Services of the National Institute of Standards & Technology” 1 and SP 260 “NIST Standard Reference Materials Catalog.” 1 A complete catalog of all publications by NIST authors is issued annually as a supplement to SP 305 “Publications of the National Institute of Standards & Technology.” Announcements and listings of recent NIST publications and services are published in each issue of the bimonthly “NIST Journal of Research” 2 and the NIST monthly magazine, “Dimensions/NIST” 2 . Complete citations to NIST publications, along with information on availability are published bimonthly in the “NIST Publications Newsletter”, available free from the Technical Information and Publications Division, National Institute of Standards & Technology, Washington, DC 20234. NIST publications are also announced (with abstracts) in “Government Reports Announcements and Index” published every two weeks by the National Technical Information Service (NTIS), Springfield, Virginia 22161 3 . NTIS also sells microfiche copies of all NIST GPO-published documents, as well as paper copy and microfiche versions of NIST Interagency Reports. 1 Single copies available free from the National Institute of Standards & Technology, Washington, DC 20234. 2 For sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402, for a subscript… | ||||||
| 15:15:1.2.2.1.1.0.5.8 | 15 | Commerce and Foreign Trade | II | A | 200 | PART 200—POLICIES, SERVICES, PROCEDURES, AND FEES | § 200.107 WWV-WWVH-WWVB broadcasts. | NIST | (a) Technical services. The NIST radio stations WWV at Fort Collins, Colorado, and WWVH on the island of Kauai, Hawaii, broadcast a number of technical services continuously night and day. These services are: (1) Standard radio frequencies, 2.5, 5, 10, 15, and 20, MHz (WWV) and 2.5, 5, 10, and 15 MHz (WWVH); (2) standard time signals; (3) time intervals; (4) UTI corrections; (5) standard audio frequencies; (6) standard musical pitch; (7) a slow time code; (8) Omega Navigation System status reports; (9) geophysical alerts; and (10) marine storm warnings. NIST also broadcasts time and frequency signals from its low frequency station, WWVB, also located at Fort Collins, Colorado. (2) [Reserved] (b) Time announcements. Once per minute voice announcements are made from WWV and WWVH. The two stations are distinguished by a female voice from WWVH and a male voice from WWV. The WWVH announcement occurs first, at 15 seconds before the minute, while the WWV announcement occurs at 7 1/2 seconds before the minute. Coordinated Universal Time (UTC) is used in these announcements. (c) Time corrections. The UTC time scale operates on atomic frequency, but by means of step adjustments is made to approximate the astronomical UTI scale. It may disagree from UTI by as much as 0.9 second before step adjustments of exactly 1 second are made. These adjustments, or leap seconds are required about once per year and will usually be made on December 31 or June 30. For those who need astronomical time more accurately than 0.9 second, a correction to UTC is encoded by the use of double ticks after the start of each minute. The first through the eighth seconds ticks will indicate a “plus” correction, and from the ninth through the 16th a “minus” correction. The correction is determined by counting the number of double ticks. For example, if the first, second, and third ticks are doubled, the correction is “plus” 0.3 second. If the ninth, 10th, 11th, and 12th ticks are doubled, the correction is “minus” 0.4 second. (d) Standard t… | ||||||
| 15:15:1.2.2.1.1.0.5.9 | 15 | Commerce and Foreign Trade | II | A | 200 | PART 200—POLICIES, SERVICES, PROCEDURES, AND FEES | § 200.108 Request procedure. | NIST | (a) A formal purchase order for the calibration or test should be sent before or at the time the instrument or standard is shipped. The purchase order should provide clear identification of the apparatus being submitted, and give separate instructions for return shipment, mailing of report, and billing. If a customer wishes to minimize the time during which the equipment is out of service, the customer can usually arrange to be notified of the scheduled test date to allow timely shipment. (See § 200.110.) Requests from Federal agencies, or from State agencies, for calibrations or tests on material to be used on private or Federal contract work should be accompanied either by purchase order or by letter or document authorizing the cost of the work to be billed to the agency. (b) The submission of a purchase order for measurement services under this subchapter shall be understood as constituting an agreement on the part of the customer to be bound by the restrictions on the use of results as set forth in § 200.113 of this part. Acceptance of purchase orders does not imply acceptance of any provisions set forth in the order contrary to the policy, practice, or regulations of NIST or the U.S. Government. (A statement to the effect that NIST is an agency of the U.S. Government should satisfy other Government agencies with regard to compliance with Government regulations and Executive orders.) (c) A test number will be assigned by NIST to each instrument or group of similar instruments or standards when the order is accepted. This test number should be referred to in all subsequent communications. Also, each instrument in a group must be uniquely identified, usually by the manufacturer's name and instrument serial number. When the serial number is lacking, an alternative identifying mark should be provided. If none is found, NIST will mark the piece with an NIST identification number. If the apparatus submitted has been previously calibrated by NIST, the serial number or identifying mark should be given on the new or… | ||||||
| 15:15:1.2.2.10.12.1.17.1 | 15 | Commerce and Foreign Trade | II | J | 280 | PART 280—FASTENER QUALITY | A | Subpart A—General | § 280.1 Description of rule/Delegation of authority. | NIST | [65 FR 39801, June 28, 2000] | (a) Description of rule. The Fastener Quality Act (the Act) (15 U.S.C. 5401 et seq., as amended by Public Law 104-113, Public Law 105-234, and Public Law 106-34): (1) Protects against the sale of mismarked, misrepresented, and counterfeit fasteners; and (2) Eliminates unnecessary requirements. (b) Delegations of authority. The Director, National Institute of Standards and Technology has authority to promulgate regulations in this part regarding certification and accreditation. The Secretary of Commerce has delegated concurrent authority to amend the regulations regarding enforcement of the Act, as contained in subpart C of this part, to the Under Secretary for Export Administration. The Secretary of Commerce has also delegated concurrent authority to amend the regulations regarding record of insignia, as contained in subpart D of this part, to the Under Secretary for Intellectual Property and Director of the United States Patent and Trademark Office. | |||
| 15:15:1.2.2.10.12.1.17.2 | 15 | Commerce and Foreign Trade | II | J | 280 | PART 280—FASTENER QUALITY | A | Subpart A—General | § 280.2 Definitions used in this subpart. | NIST | [61 FR 50558, Sept. 26, 1996. Redesignated and amended at 65 FR 39801, June 28, 2000] | In addition to the definitions provided in 15 U.S.C. 5402, the following definitions are applicable to this part: Abandonment of the Application. The application for registration of a trademark on the Principal Register is no longer pending at the United States Patent and Trademark Office. Act. The Fastener Quality Act (15 U.S.C. 5401 et seq., as amended by Pub. L. 104-113, Pub. L. 105-234, and Public Law 106-34). Administrative law judge (ALJ). The person authorized to conduct hearings in administrative enforcement proceedings brought under the Act. Assistant Secretary. The Assistant Secretary for Export Enforcement, Bureau of Export Administration. Department. The United States Department of Commerce, specifically, the Bureau of Export Administration, NIST and the Patent and Trademark Office. Director, NIST. The Director of the National Institute of Standards and Technology. Director, USPTO. The Under Secretary for Intellectual Property and Director of the United States Patent and Trademark Office. Fastener Insignia Register. The register of recorded fastener insignias maintained by the Director. Final decision. A decision or order assessing a civil penalty or otherwise disposing of or dismissing a case, which is not subject to further review under this part, but which is subject to collection proceedings or judicial review in an appropriate Federal district court as authorized by law. Initial decision. A decision of the administrative law judge which is subject to review by the Under Secretary for Export Administration, but which becomes the final decision of the Department in the absence of such an appeal. Party. The Department and any person named as a respondent under this part. Principal Register. The register of trademarks established under 15 U.S.C. 1051. Respondent. Any person named as the subject of a charging letter, proposed charging letter, or other order proposed or issued under this part. Revisions includes changes made to existing ISO/IEC Guides or other documents, a… | |||
| 15:15:1.2.2.10.12.2.17.1 | 15 | Commerce and Foreign Trade | II | J | 280 | PART 280—FASTENER QUALITY | B | Subpart B—Petitions, Affirmations, and Laboratory Accreditation | § 280.101 Petitions for approval of documents. | NIST | (a) Certification. (1) A person publishing a document setting forth guidance or requirements for the certification of manufacturing systems as fastener quality assurance systems by an accredited third party may petition the Director, NIST, to approve such document for use as described in section 3(7)(B)(iii)(I) of the Act (15 U.S.C. 5402(7)(B)(iii)(I)). (2) Petitions should be submitted to: FQA Document Certification, NIST, 100 Bureau Drive, Gaithersburg, MD 20899. (3) The Director, NIST, shall approve such petition if the document provides equal or greater rigor and reliability as compared to ISO/IEC Guide 62, including revisions from time to time. A petition shall contain sufficient information to allow the Director, NIST, to make this determination. (b) Accreditation. (1) A person publishing a document setting forth guidance or requirements for the approval of accreditation bodies to accredit third parties described in paragraph (a) of this section may petition the Director, NIST, to approve such document for use as described in section 3(7)(B)(iii)(I) of the Act (15 U.S.C. 5402(7)(B)(iii)(I)). (2) Petitions should be submitted to: FQA Document Certifications, NIST, 100 Bureau Drive, Gaithersburg, MD 20899. (3) The Director, NIST, shall approve such petition if the document provides equal or greater rigor and reliability as compared to ISO/IEC Guide 61, including revisions from time to time. A petition shall contain sufficient information to allow the Director, NIST, to make this determination. (c) Laboratory accreditation. (1) A person publishing a document setting forth guidance or requirements for the accreditation of laboratories may petition the Director, NIST, to approve such document for use as described in section 3(1)(A) of the Act (15 U.S.C. 5402(1)(A)). (2) Petitions should be submitted to: FQA Document Certifications, NIST, 100 Bureau Drive, Gaithersburg, MD 20899. (3) The Director, NIST, shall approve such petition if the document provides equal or greater rigor and reliability as co… | ||||
| 15:15:1.2.2.10.12.2.17.2 | 15 | Commerce and Foreign Trade | II | J | 280 | PART 280—FASTENER QUALITY | B | Subpart B—Petitions, Affirmations, and Laboratory Accreditation | § 280.102 Affirmations. | NIST | (a)(1) An accreditation body accrediting third parties who certify manufacturing systems as fastener quality assurance systems as described in section 3(7)(B)(iii)(I) of the Act (15 U.S.C. 5402(7)(B)(iii)(I)) shall affirm to the Director, NIST, that it meets the requirements of ISO/IEC Guide 61 (or another document approved by the Director, NIST, under section 10(b) of the Act (15 U.S.C. 5411a(b)) and § 280.101(a) of this part), including revisions from time to time. (2) An accreditation body accrediting laboratories as described in section 3(1)(B) of the Act (15 U.S.C. 5402(1)(B)) shall affirm to the Director, NIST, that it meets the requirements of ISO/IEC Guide 58 (or another document approved by the Director, NIST, under section 10(d) of the Act (15 U.S.C. 5411a(d)) and § 280.101(d) of this part), including revisions from time to time. (b) An affirmation required under paragraph (a)(1) or (a)(2) of this section shall take the form of a self-declaration that the accreditation body meets the requirements of the applicable Guide, signed by an authorized representative of the accreditation body. No supporting documentation is required. (c) Affirmations should be submitted to: FQA Document Certifications, NIST, 100 Bureau Drive, Gaithersburg, MD 20899. (d) Any affirmation submitted in accordance with this section shall be considered to be a continuous affirmation that the accreditation body meets the requirements of the applicable Guide, unless and until the affirmation is withdrawn by the accreditation body. | ||||
| 15:15:1.2.2.10.12.2.17.3 | 15 | Commerce and Foreign Trade | II | J | 280 | PART 280—FASTENER QUALITY | B | Subpart B—Petitions, Affirmations, and Laboratory Accreditation | § 280.103 Laboratory accreditation. | NIST | A laboratory may be accredited by any laboratory accreditation program that may be established by any entity or entities, which have affirmed to the Director, NIST, under § 280.102 of this subpart, or by the National Voluntary Laboratory Accreditation Program for fasteners, established by the Director, NIST, under part 285 of this chapter. | ||||
| 15:15:1.2.2.10.12.3.17.1 | 15 | Commerce and Foreign Trade | II | J | 280 | PART 280—FASTENER QUALITY | C | Subpart C—Enforcement | § 280.200 Scope. | NIST | [65 FR 39802, June 28, 2000] | Section 280.201 of this part specifies that failure to take any action required by or taking any action prohibited by this part constitutes a violation of this part. Section 280.202 describes the penalties that may be imposed for violations of this part. Sections 280.204 through 280.222 establish the procedures for imposing administrative penalties for violations of this part. | |||
| 15:15:1.2.2.10.12.3.17.10 | 15 | Commerce and Foreign Trade | II | J | 280 | PART 280—FASTENER QUALITY | C | Subpart C—Enforcement | § 280.209 Summary decision. | NIST | At any time after a proceeding has been initiated, a party may move for a summary decision disposing of some or all of the issues. The administrative law judge may render an initial decision and issue an order if the entire record shows, as to the issue(s) under consideration: (a) That there is no genuine issue as to any material fact; and (b) That the moving party is entitled to a summary decision as a matter of law. | ||||
| 15:15:1.2.2.10.12.3.17.11 | 15 | Commerce and Foreign Trade | II | J | 280 | PART 280—FASTENER QUALITY | C | Subpart C—Enforcement | § 280.210 Discovery. | NIST | [61 FR 50558, Sept. 26, 1996. Redesignated and amended at 65 FR 39802, June 28, 2000] | (a) General. The parties are encouraged to engage in voluntary discovery regarding any matter, not privileged, which is relevant to the subject matter of the pending proceeding. The provisions of the Federal Rules of Civil Procedure relating to discovery apply to the extent consistent with this part and except as otherwise provided by the administrative law judge or by waiver or agreement of the parties. The administrative law judge may make any order which justice requires to protect a party or person from annoyance, embarrassment, oppression, or undue burden or expense. These orders may include limitations on the scope, method, time and place of discovery, and provisions for protecting the confidentiality of classified or otherwise sensitive information. (b) Interrogatories and requests for admission or production of documents. A party may serve on any party interrogatories, requests for admission, or requests for production of documents for inspection and copying, and a party concerned may apply to the administrative law judge for such enforcement or protective order as that party deems warranted with respect to such discovery. The service of a discovery request shall be made at least 20 days before the scheduled date of the hearing unless the administrative law judge specifies a shorter time period. Copies of interrogatories, requests for admission and requests for production of documents and responses thereto shall be served on all parties, and a copy of the certificate of service shall be filed with the administrative law judge. Matters of fact or law of which admission is requested shall be deemed admitted unless, within a period designated in the request (at least 10 days after service, or within such additional time as the administrative law judge may allow), the party to whom the request is directed serves upon the requesting party a sworn statement either denying specifically the matters of which admission is requested or setting forth in detail the reasons why the party to whom the request is dir… | |||
| 15:15:1.2.2.10.12.3.17.12 | 15 | Commerce and Foreign Trade | II | J | 280 | PART 280—FASTENER QUALITY | C | Subpart C—Enforcement | § 280.211 Subpoenas. | NIST | [61 FR 50558, Sept. 26, 1996. Redesignated and amended at 65 FR 39802, June 28, 2000] | (a) Issuance. Upon the application of any party, supported by a satisfactory showing that there is substantial reason to believe that the evidence would not otherwise be available, the administrative law judge may issue subpoenas requiring the attendance and testimony of witnesses and the production of such books, records or other documentary or physical evidence for the purpose of the hearing, as the ALJ deems relevant and material to the proceedings, and reasonable in scope. Witnesses summoned shall be paid the same fees and mileage that are paid to witnesses in the courts of the United States. In case of contempt or refusal to obey a subpoena served upon any person pursuant to this paragraph, the district court of the United States for any district in which such person is found, resides, or transacts business, upon application by the United States and after notice to such person, shall have jurisdiction to issue an order requiring such person to appear and give testimony before the administrative law judge or to appear and produce documents before the administrative law judge, or both, and any failure to obey such order of the court may be punished by such court as contempt thereof. (b) Service. Subpoenas issued by the administrative law judge may be served in any of the methods set forth in § 280.206(b) of this part. (c) Timing. Applications for subpoenas must be submitted at least 10 days before the scheduled hearing or deposition, unless the administrative law judge determines, for good cause shown, that extraordinary circumstances warrant a shorter time. | |||
| 15:15:1.2.2.10.12.3.17.13 | 15 | Commerce and Foreign Trade | II | J | 280 | PART 280—FASTENER QUALITY | C | Subpart C—Enforcement | § 280.212 Matter protected against disclosure. | NIST | (a) Protective measures. The administrative law judge may limit discovery or introduction of evidence or issue such protective or other orders as in the ALJ's judgment may be needed to prevent undue disclosure of classified or sensitive documents or information. Where the administrative law judge determines that documents containing the classified or sensitive matter need to be made available to a party to avoid prejudice, the ALJ may direct that an unclassified and/or nonsensitive summary or extract of the documents be prepared. The administrative law judge may compare the extract or summary with the original to ensure that it is supported by the source document and that it omits only so much as must remain undisclosed. The summary or extract may be admitted as evidence in the record. (b) Arrangements for access. If the administrative law judge determines that this procedure is unsatisfactory and that classified or otherwise sensitive matter must form part of the record in order to avoid prejudice to a party, the administrative law judge may provide the parties an opportunity to make arrangements that permit a party or a representative to have access to such matter without compromising sensitive information. Such arrangements may include obtaining security clearances or giving counsel for a party access to sensitive information and documents subject to assurances against further disclosure, including a protective order, if necessary. | ||||
| 15:15:1.2.2.10.12.3.17.14 | 15 | Commerce and Foreign Trade | II | J | 280 | PART 280—FASTENER QUALITY | C | Subpart C—Enforcement | § 280.213 Prehearing conference. | NIST | (a) The administrative law judge, on his or her own motion or on request of a party, may direct the parties to participate in a prehearing conference, either in person or by telephone, to consider: (1) Simplification of issues; (2) The necessity or desirability of amendments to pleadings; (3) Obtaining stipulations of fact and of documents to avoid unnecessary proof; or (4) Such other matters as may expedite the disposition of the proceedings. (b) The administrative law judge may order the conference proceedings to be recorded electronically or taken by a reporter, transcribed and filed with the ALJ. (c) If a prehearing conference is impracticable, the administrative law judge may direct the parties to correspond with the ALJ to achieve the purposes of such a conference. (d) The administrative law judge will prepare a summary of any actions agreed on or taken pursuant to this section. The summary will include any written stipulations or agreements made by the parties. | ||||
| 15:15:1.2.2.10.12.3.17.15 | 15 | Commerce and Foreign Trade | II | J | 280 | PART 280—FASTENER QUALITY | C | Subpart C—Enforcement | § 280.214 Hearings. | NIST | [61 FR 50558, Sept. 26, 1996. Redesignated and amended at 65 FR 39802, June 28, 2000] | (a) Scheduling. The administrative law judge, by agreement with the parties or upon notice to all parties of not less than 30 days, will schedule a hearing. All hearings will be held in Washington, DC., unless the administrative law judge determines, for good cause shown, that another location would better serve the interests of justice. (b) Hearing procedure. Hearings will be conducted in a fair and impartial manner by the administrative law judge, who may limit attendance at any hearing or portion thereof to the parties, their representatives and witnesses if the administrative law judge deems this necessary or advisable in order to protect sensitive matter (see § 280.212 of this part) from improper disclosure. The rules of evidence prevailing in courts of law do not apply, and all evidentiary material deemed by the administrative law judge to be relevant and material to the proceeding and not unduly repetitious will be received and given appropriate weight. (c) Testimony and record. Witnesses will testify under oath or affirmation. A verbatim record of the hearing and of any other oral proceedings will be taken by reporter or by electronic recording, transcribed and filed with the administrative law judge. A respondent may examine the transcript and may obtain a copy by paying any applicable costs. Upon such terms as the administrative law judge deems just, the ALJ may direct that the testimony of any person be taken by deposition and may admit an affidavit or declaration as evidence, provided that any affidavits or declarations have been filed and served on the parties sufficiently in advance of the hearing to permit a party to file and serve an objection thereto on the grounds that it is necessary that the affiant or declarant testify at the hearing and be subject to cross-examination. (d) Failure to appear. If a party fails to appear in person or by counsel at a scheduled hearing, the hearing may nevertheless proceed, and that party's failure to appear will not affect the validity of the hearing … | |||
| 15:15:1.2.2.10.12.3.17.16 | 15 | Commerce and Foreign Trade | II | J | 280 | PART 280—FASTENER QUALITY | C | Subpart C—Enforcement | § 280.215 Interlocutory review of rulings. | NIST | (a) At the request of a party, or on the administrative law judge's own initiative, the administrative law judge may certify to the Under Secretary for review a ruling that does not finally dispose of a proceeding, if the administrative law judge determines that immediate review may hasten or facilitate the final disposition of the matter. (b) Upon certification to the Under Secretary of the interlocutory ruling for review, the parties will have 10 days to file and serve briefs stating their positions, and five days to file and serve replies, following which the Under Secretary will decide the matter promptly. | ||||
| 15:15:1.2.2.10.12.3.17.17 | 15 | Commerce and Foreign Trade | II | J | 280 | PART 280—FASTENER QUALITY | C | Subpart C—Enforcement | § 280.216 Proceeding without a hearing. | NIST | If the parties have waived a hearing, the case will be decided on the record by the administrative law judge. Proceeding without a hearing does not relieve the parties from the necessity of proving the facts supporting their charges or defenses. Affidavits or declarations, depositions, admissions, answers to interrogatories and stipulations may supplement other documentary evidence in the record. The administrative law judge will give each party reasonable opportunity to file rebuttal evidence. | ||||
| 15:15:1.2.2.10.12.3.17.18 | 15 | Commerce and Foreign Trade | II | J | 280 | PART 280—FASTENER QUALITY | C | Subpart C—Enforcement | § 280.217 Procedural stipulations; extension of time. | NIST | (a) Procedural stipulations. Unless otherwise ordered, a written stipulation agreed to by all parties and filed with the administrative law judge will modify any procedures established by this part. (b) Extension of time. (1) The parties may extend any applicable time limitation, by stipulation filed with the administrative law judge before the time limitation expires. (2) The administrative law judge may, on the judge's own initiative or upon application by any party, either before or after the expiration of any applicable time limitation, extend the time within which to file and serve an answer to a charging letter or do any other act required by this part. | ||||
| 15:15:1.2.2.10.12.3.17.19 | 15 | Commerce and Foreign Trade | II | J | 280 | PART 280—FASTENER QUALITY | C | Subpart C—Enforcement | § 280.218 Decision of the administrative law judge. | NIST | [61 FR 50558, Sept. 26, 1996. Redesignated and amended at 65 FR 39802, 39803, June 28, 2000] | (a) Predecisional matters. Except for default proceedings under § 280.208 of this part, the administrative law judge will give the parties reasonable opportunity to submit the following, which will be made a part of the record: (1) Exceptions to any ruling by the judge or to the admissibility of evidence proffered at the hearing; (2) Proposed findings of fact and conclusions of law; (3) Supporting legal arguments for the exceptions and proposed findings and conclusions submitted; and (4) A proposed order. (b) Decision and order. After considering the entire record in the proceeding, the administrative law judge will issue a written initial decision. The decision will include findings of fact, conclusions of law, and findings as to whether there has been a violation of the Act, this part, or any order issued thereunder. If the administrative law judge finds that the evidence of record is insufficient to sustain a finding that a violation has occurred with respect to one or more charges, the ALJ shall order dismissal of the charges in whole or in part, as appropriate. If the administrative law judge finds that one or more violations have been committed, the ALJ may issue an order imposing administrative sanctions, as provided in this part. The decision and order shall be served on each party, and shall become effective as the final decision of the Department 30 days after service, unless an appeal is filed in accordance with § 280.222 of this part. In determining the amount of any civil penalty the ALJ shall consider the nature, circumstances and gravity of the violation and, with respect to the person found to have committed the violation, the degree of culpability, any history of prior violations, the effect on ability to continue to do business, any good faith attempt to achieve compliance, ability to pay the penalty, and such other matters as justice may require. (c) Suspension of sanctions. Any order imposing administrative sanctions may provide for the suspension of the sanction imposed, in whole … | |||
| 15:15:1.2.2.10.12.3.17.2 | 15 | Commerce and Foreign Trade | II | J | 280 | PART 280—FASTENER QUALITY | C | Subpart C—Enforcement | § 280.201 Violations. | NIST | [61 FR 50558, Sept. 26, 1996, as amended at 63 FR 18275, Apr. 14, 1998; 63 FR 34965, June 26, 1998; 63 FR 51526, Sept. 28, 1998. Redesignated and amended at 65 FR 39802, June 28, 2000] | (a) Engaging in prohibited conduct. No person may engage in any conduct prohibited by or contrary to, or refrain from engaging in any action required by the Act, this part, or any order issued thereunder. (b) Sale of fasteners. It shall be unlawful for a manufacturer or distributor, in conjunction with the sale or offer for sale of fasteners from a single lot, to knowingly misrepresent or falsify— (1) The record of conformance for the lot of fasteners; (2) The identification, characteristics, properties, mechanical or performance marks, chemistry, or strength of the lot of fasteners; or (3) The manufacturers' insignia. (c) Manufacturers' insignia. Unless the specifications provide otherwise, fasteners that are required by the applicable consensus standard or standards to bear an insignia identifying their manufacturer shall not be offered for sale or sold in commerce unless (1) The fasteners bear such insignia; and (2) The manufacturer has complied with the insignia recordation requirements established under 15 U.S.C. 5407(b). | |||
| 15:15:1.2.2.10.12.3.17.20 | 15 | Commerce and Foreign Trade | II | J | 280 | PART 280—FASTENER QUALITY | C | Subpart C—Enforcement | § 280.219 Settlement. | NIST | [61 FR 50558, Sept. 26, 1996. Redesignated and amended at 65 FR 39802, 39803, June 28, 2000] | (a) Cases may be settled before service of a charging letter. In cases in which settlement is reached before service of a charging letter, a proposed charging letter will be prepared, and a settlement proposal consisting of a settlement agreement and order will be submitted to the Assistant Secretary for approval and signature. If the Assistant Secretary does not approve the proposal, he/she will notify the parties and the case will proceed as though no settlement proposal had been made. If the Assistant Secretary approves the proposal, he/she will issue an appropriate order, and no action will be required by the administrative law judge. (b) Cases may also be settled after service of a charging letter. (1) If the case is pending before the administrative law judge, the ALJ shall stay the proceedings for a reasonable period of time, usually not to exceed 30 days, upon notification by the parties that they have entered into good faith settlement negotiations. The administrative law judge may, in his/her discretion, grant additional stays. If settlement is reached, a proposal will be submitted to the Assistant Secretary for approval and signature. If the Assistant Secretary approves the proposal, he/she will issue an appropriate order, and notify the administrative law judge that the case is withdrawn from adjudication. If the Assistant Secretary does not approve the proposal, he/she will notify the parties and the case will proceed to adjudication by the administrative law judge as though no settlement proposal had been made. (2) If the case is pending before the Under Secretary under § 280.222 of this part, the parties may submit a settlement proposal to the Under Secretary for approval and signature. If the Under Secretary approves the proposal, he/she will issue an appropriate order. If the Under Secretary does not approve the proposal, the case will proceed to final decision in accordance with Section 280.623 of this part, as appropriate. (c) Any order disposing of a case by settlement may suspend the a… | |||
| 15:15:1.2.2.10.12.3.17.21 | 15 | Commerce and Foreign Trade | II | J | 280 | PART 280—FASTENER QUALITY | C | Subpart C—Enforcement | § 280.220 Reopening. | NIST | [61 FR 50558, Sept. 26, 1996. Redesignated and amended at 65 FR 39802, 39803, June 28, 2000] | The respondent may petition the administrative law judge within one year of the date of the final decision, except where the decision arises from a default judgment or from a settlement, to reopen an administrative enforcement proceeding to receive any relevant and material evidence which was unknown or unobtainable at the time the proceeding was held. The petition must include a summary of such evidence, the reasons why it is deemed relevant and material, and the reasons why it could not have been presented at the time the proceedings were held. The administrative law judge will grant or deny the petition after providing other parties reasonable opportunity to comment. If the proceeding is reopened, the administrative law judge may make such arrangements as the ALJ deems appropriate for receiving the new evidence and completing the record. The administrative law judge will then issue a new initial decision and order, and the case will proceed to final decision and order in accordance with § 280.222 of this part. | |||
| 15:15:1.2.2.10.12.3.17.22 | 15 | Commerce and Foreign Trade | II | J | 280 | PART 280—FASTENER QUALITY | C | Subpart C—Enforcement | § 280.221 Record for decision and availability of documents. | NIST | [61 FR 50558, Sept. 26, 1996. Redesignated and amended at 65 FR 39802, 39803, June 28, 2000] | (a) General. The transcript of hearings, exhibits, rulings, orders, all papers and requests filed in the proceedings and, for purposes of any appeal under § 280.222 of this part, the decision of the administrative law judge and such submissions as are provided for by § 280.623 of this part, will constitute the record and the exclusive basis for decision. When a case is settled after the service of a charging letter, the record will consist of any and all of the foregoing, as well as the settlement agreement and the order. When a case is settled before service of a charging letter, the record will consist of the proposed charging letter, the settlement agreement and the order. (b) Restricted access. On the administrative law judge's own motion, or on the motion of any party, the administrative law judge may direct that there be a restricted access portion of the record for any material in the record to which public access is restricted by law or by the terms of a protective order entered in the proceedings. A party seeking to restrict access to any portion of the record is responsible for submitting, at the time specified in paragraph (c)(2) of this section, a version of the document proposed for public availability that reflects the requested deletion. The restricted access portion of the record will be placed in a separate file and the file will be clearly marked to avoid improper disclosure and to identify it as a portion of the official record in the proceedings. The administrative law judge may act at any time to permit material that becomes declassified or unrestricted through passage of time to be transferred to the unrestricted access portion of the record. (c) Availability of documents —(1) Scope. All charging letters, answers, initial decisions, and orders disposing of a case will be made available for public inspection in the BXA Freedom of Information Records Inspection Facility, U.S. Department of Commerce, Room H-6624, 14th Street and Pennsylvania Avenue, NW, Washington, DC 20230. The comple… | |||
| 15:15:1.2.2.10.12.3.17.23 | 15 | Commerce and Foreign Trade | II | J | 280 | PART 280—FASTENER QUALITY | C | Subpart C—Enforcement | § 280.222 Appeals. | NIST | [61 FR 50558, Sept. 26, 1996. Redesignated and amended at 65 FR 39802, June 28, 2000] | (a) Grounds. A party may appeal to the Under Secretary from an order disposing of a proceeding or an order denying a petition to set aside a default or a petition for reopening, on the grounds: (1) That a necessary finding of fact is omitted, erroneous or unsupported by substantial evidence of record; (2) That a necessary legal conclusion or finding is contrary to law; (3) That prejudicial procedural error occurred; or (4) That the decision or the extent of sanctions is arbitrary, capricious or an abuse of discretion. The appeal must specify the grounds on which the appeal is based and the provisions of the order from which the appeal is taken. (b) Filing of appeal. An appeal from an order must be filed with the Office of the Under Secretary for Export Administration, Bureau of Export Administration, U.S. Department of Commerce, Room H-3898, 14th Street and Constitution Avenue, NW., Washington, DC 20230, within 30 days after service of the order appealed from. If the Under Secretary cannot act on an appeal for any reason, the Under Secretary will designate another Department of Commerce official to receive and act on the appeal. (c) Effect of appeal. The filing of an appeal shall not stay the operation of any order, unless the order by its express terms so provides or unless the Under Secretary, upon application by a party and with opportunity for response, grants a stay. (d) Appeal procedure. The Under Secretary normally will not hold hearings or entertain oral argument on appeals. A full written statement in support of the appeal must be filed with the appeal and be simultaneously served on all parties, who shall have 30 days from service to file a reply. At his/her discretion, the Under Secretary may accept new submissions, but will not ordinarily accept those submissions filed more than 30 days after the filing of the reply to the appellant's first submission. (e) Decisions. The decision will be in writing and will be accompanied by an order signed by the Under Secretary giving effect to the… | |||
| 15:15:1.2.2.10.12.3.17.3 | 15 | Commerce and Foreign Trade | II | J | 280 | PART 280—FASTENER QUALITY | C | Subpart C—Enforcement | § 280.202 Penalties, remedies, and sanctions. | NIST | (a) Civil remedies. The Attorney General may bring an action in an appropriate United States district court for declaratory and injunctive relief against any person who violates the Act or any regulation issued thereunder. Such action may not be brought more than 10 years after the cause of action accrues. (b) Civil penalties. Any person who is determined, after notice and opportunity for a hearing, to have violated the Act or any regulation issued thereunder shall be liable to the United States for a civil penalty of not more than $25,000 for each violation. (c) Criminal penalties. (1) Whoever knowingly certifies, marks, offers for sale, or sells a fastener in violation of the Act or a regulation issued thereunder shall be fined under title 18, United States Code, or imprisoned not more than 5 years, or both. (2) Whoever intentionally fails to maintain records relating to a fastener in violation of the Act or a regulation issued thereunder shall be fined under title 18, United States Code, or imprisoned not more than five years or both. (3) Whoever negligently fails to maintain records relating to a fastener in violation of the Act or a regulation issued thereunder shall be fined under title 18, United States Code, or imprisoned not more than two years or both. | ||||
| 15:15:1.2.2.10.12.3.17.4 | 15 | Commerce and Foreign Trade | II | J | 280 | PART 280—FASTENER QUALITY | C | Subpart C—Enforcement | § 280.203 Administrative enforcement proceedings. | NIST | [65 FR 39802, June 28, 2000] | Sections 280.204 through 280.222 set forth the procedures for imposing administrative penalties for violations of the Act and this part. | |||
| 15:15:1.2.2.10.12.3.17.5 | 15 | Commerce and Foreign Trade | II | J | 280 | PART 280—FASTENER QUALITY | C | Subpart C—Enforcement | § 280.204 Institution of administrative enforcement proceedings. | NIST | [61 FR 50558, Sept. 26, 1996. Redesignated and amended at 65 FR 39802, June 28, 2000] | (a) Charging letters. The Director of the Office of Export Enforcement (OEE) may begin administrative enforcement proceedings under this part by issuing a charging letter. The charging letter shall constitute the formal complaint and will state that there is reason to believe that a violation of this part has occurred. It will set forth the essential facts about each alleged violation, refer to the specific regulatory or other provisions involved, and give notice of the sanctions available under the Act and this part. The charging letter will inform the respondent that failure to answer the charges as provided in § 280.207 of this part will be treated as a default under § 280.208 of this part, that the respondent is entitled to a hearing if a written demand for one is requested with the answer, and that the respondent may be represented by counsel, or by other authorized representative. A copy of the charging letter shall be filed with the administrative law judge, which filing shall toll the running of the applicable statute of limitations. Charging letters may be amended or supplemented at any time before an answer is filed, or, with permission of the administrative law judge, afterwards. The Department may unilaterally withdraw charging letters at any time, by notifying the respondent and the administrative law judge. (b) Notice of issuance of charging letter instituting administrative enforcement proceeding. A respondent shall be notified of the issuance of a charging letter, or any amendment or supplement thereto: (1) By mailing a copy by registered or certified mail addressed to the respondent at the respondent's last known address; (2) By leaving a copy with the respondent or with an officer, a managing or general agent, or any other agent authorized by appointment or by law to receive service of process for the respondent; or (3) By leaving a copy with a person of suitable age and discretion who resides at the respondent's last known dwelling. (4) Delivery of a copy of the charging letter, if mad… | |||
| 15:15:1.2.2.10.12.3.17.6 | 15 | Commerce and Foreign Trade | II | J | 280 | PART 280—FASTENER QUALITY | C | Subpart C—Enforcement | § 280.205 Representation. | NIST | A respondent individual may appear and participate in person, a corporation by a duly authorized officer or employee, and a partnership by a partner. If a respondent is represented by counsel, counsel shall be a member in good standing of the bar of any State, Commonwealth or Territory of the United States, or of the District of Columbia, or be licensed to practice law in the country in which counsel resides if not the United States. A respondent personally, or through counsel or other representative who has the power of attorney to represent the respondent, shall file a notice of appearance with the administrative law judge. The Department will be represented by the Office of Chief Counsel for Export Administration, U.S. Department of Commerce. | ||||
| 15:15:1.2.2.10.12.3.17.7 | 15 | Commerce and Foreign Trade | II | J | 280 | PART 280—FASTENER QUALITY | C | Subpart C—Enforcement | § 280.206 Filing and service of papers other than charging letter. | NIST | (a) Filing. All papers to be filed shall be addressed to “FQA Administrative Enforcement Proceedings,” at the address set forth in the charging letter, or such other place as the administrative law judge may designate. Filing by United States mail, first class postage prepaid, by express or equivalent parcel delivery service, or by hand delivery, is acceptable. Filing by mail from a foreign country shall be by airmail. In addition, the administrative law judge may authorize filing of papers by facsimile or other electronic means, provided that a hard copy of any such paper is subsequently filed. A copy of each paper filed shall be simultaneously served on each party. (b) Service. Service shall be made by personal delivery or by mailing one copy of each paper to each party in the proceeding. Service by delivery service or facsimile, in the manner set forth in paragraph (a) of this section, is acceptable. Service on the Department shall be addressed to the Chief Counsel for Export Administration, Room H-3839, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW., Washington, DC 20230. Service on a respondent shall be to the address to which the charging letter was sent or to such other address as respondent may provide. When a party has appeared by counsel or other representative, service on counsel or other representative shall constitute service on that party. (c) Date. The date of filing or service is the day when the papers are deposited in the mail or are delivered in person, by delivery service, or by facsimile. (d) Certificate of service. A certificate of service signed by the party making service, stating the date and manner of service, shall accompany every paper, other than the charging letter, filed and served on parties. (e) Computing period of time. In computing any period of time prescribed or allowed by this part or by order of the administrative law judge or the Under Secretary, the day of the act, event, or default from which the designated period of time begins to run… | ||||
| 15:15:1.2.2.10.12.3.17.8 | 15 | Commerce and Foreign Trade | II | J | 280 | PART 280—FASTENER QUALITY | C | Subpart C—Enforcement | § 280.207 Answer and demand for hearing. | NIST | [61 FR 50558, Sept. 26, 1996. Redesignated and amended at 65 FR 39802, June 28, 2000] | (a) When to answer. The respondent must answer the charging letter within 30 days after being served with notice of the issuance of a charging letter instituting an administrative enforcement proceeding, or within 30 days of notice of any supplement or amendment to a charging letter, unless time is extended under § 280.217 of this part. (b) Contents of answer. The answer must be responsive to the charging letter and must fully set forth the nature of the respondent's defense or defenses. The answer must admit or deny specifically each separate allegation of the charging letter; if the respondent is without knowledge, the answer must so state and will operate as a denial. Failure to deny or controvert a particular allegation will be deemed an admission of that allegation. The answer must also set forth any additional or new matter the respondent believes supports a defense or claim of mitigation. Any defense or partial defense not specifically set forth in the answer shall be deemed waived, and evidence thereon may be refused, except for good cause shown. (c) Demand for hearing. If the respondent desires a hearing, a written demand for one must be submitted with the answer. Any demand by the Department for a hearing must be filed with the administrative law judge within 30 days after service of the answer. Failure to make a timely written demand for a hearing shall be deemed a waiver of the party's right to a hearing, except for good cause shown. If no party demands a hearing, the matter will go forward in accordance with the procedures set forth in § 280.216 of this part. (d) English language required. The answer, all other papers, and all documentary evidence must be submitted in English, or translations into English must be filed and served at the same time. | |||
| 15:15:1.2.2.10.12.3.17.9 | 15 | Commerce and Foreign Trade | II | J | 280 | PART 280—FASTENER QUALITY | C | Subpart C—Enforcement | § 280.208 Default. | NIST | [61 FR 50558, Sept. 26, 1996. Redesignated and amended at 65 FR 39802, 39803, June 28, 2000] | (a) General. Failure of the respondent to file an answer within the time provided constitutes a waiver of the respondent's right to appear and contest the allegations in the charging letter. In such event, the administrative law judge, on the Department's motion and without further notice to the respondent, shall find the facts to be as alleged in the charging letter and render an initial decision containing findings of fact and appropriate conclusions of law and issue an initial decision and order imposing appropriate sanctions. The decision and order may be appealed to the Under Secretary in accordance with the applicable procedures set forth in § 280.222 of this part. (b) Petition to set aside default —(1) Procedure. Upon petition filed by a respondent against whom a default order has been issued, which petition is accompanied by an answer meeting the requirements of 280.207(b) of this part, the Under Secretary may, after giving all parties an opportunity to comment, and for good cause shown, set aside the default and vacate the order entered thereon and remand the matter to the administrative law judge for further proceedings. (2) Time limits. A petition under this section must be made within one year of the date of entry of the order which the petition seeks to have vacated. | |||
| 15:15:1.2.2.10.12.4.17.1 | 15 | Commerce and Foreign Trade | II | J | 280 | PART 280—FASTENER QUALITY | D | Subpart D—Recordal of Insignia | § 280.300 Recorded insignia required prior to offer for sale. | NIST | [65 FR 39803, June 28, 2000] | Unless the specifications provide otherwise, if a fastener is required by the applicable consensus standard(s) to bear an insignia identifying its manufacturer, the manufacturer must: (a) Record the insignia with the U.S. Patent and Trademark Office prior to any sale or offer for sale of the fastener; and (b) Apply the insignia to any fastener that is sold or offered for sale. The insignia must be readable, and must be applied using the method for applying a permanent insignia that is provided for in the applicable consensus standard(s), or, if the applicable consensus standard(s) do(es) not specify a method for applying a permanent insignia, through any means of imprinting a permanent impression. | |||
| 15:15:1.2.2.10.12.4.17.2 | 15 | Commerce and Foreign Trade | II | J | 280 | PART 280—FASTENER QUALITY | D | Subpart D—Recordal of Insignia | § 280.310 Application for insignia. | NIST | [61 FR 50558, Sept. 26, 1996. Redesignated and amended at 65 FR 39803, June 28, 2000; 70 FR 50181, Aug. 26, 2005; 72 FR 30704, June 4, 2007] | (a) Each manufacturer must submit a written application for recordal of an insignia on the Fastener Insignia Register along with the prescribed fee. The application must be in a form prescribed by the Director, USPTO. (b) The written application must be in the English language and must include the following: (1) The name of the manufacturer; (2) The address of the manufacturer; (3) The entity, domicile, and state of incorporation, if applicable, of the manufacturer; (4) Either: (i) A request for recordal and issuance of a unique alphanumeric designation by the Director, USPTO, or (ii) A request for recordal of a trademark, which is the subject of either a duly filed application or a registration for fasteners in the name of the manufacturer in the U.S. Patent and Trademark Office on the Principal Register, indicating the application serial number or registration number and accompanied by a copy of the drawing that was included with the application for trademark registration, or a copy of the registration; (5) A statement that the manufacturer will comply with the applicable provisions of the Fastener Quality Act; (6) A statement that the applicant for recordal is a “manufacturer” as that term is defined in 15 U.S.C. 5402; (7) A statement that the person signing the application on behalf of the manufacturer has personal knowledge of the facts relevant to the application and that the person possesses the authority to act on behalf of the manufacturer; (8) A verification stating that the person signing declares under penalty of perjury under the laws of the United States of America that the information and statements included in the application are true and correct; and (9) The application fee. (c) A manufacturer may designate only one trademark for recordal on the Fastener Insignia Register in a single application. The trademark application or registration that forms the basis for the fastener recordal must be in active status, that is, a pending application or a registration which is not expired, or c… | |||
| 15:15:1.2.2.10.12.4.17.3 | 15 | Commerce and Foreign Trade | II | J | 280 | PART 280—FASTENER QUALITY | D | Subpart D—Recordal of Insignia | § 280.311 Review of the application. | NIST | [65 FR 39803, June 28, 2000] | The Director, USPTO, will review the application for compliance with § 280.310. If the application does not contain one or more of the elements required by § 280.310, the Director, USPTO, will not issue a certificate of recordal, and will return the papers and fees. The Director, USPTO, will notify the applicant for recordal of any defect in the application. Applications for recordal of an insignia may be re-submitted to the Director, USPTO, at any time. | |||
| 15:15:1.2.2.10.12.4.17.4 | 15 | Commerce and Foreign Trade | II | J | 280 | PART 280—FASTENER QUALITY | D | Subpart D—Recordal of Insignia | § 280.312 Certificate of recordal. | NIST | [65 FR 39803, June 28, 2000] | (a) If the application complies with the requirements of § 280.310, the Director, USPTO, shall accept the application and issue a certificate of recordal. Such certificate shall be issued in the name of the United States of America, under the seal of the United States Patent and Trademark Office, and a record shall be kept in the United States Patent and Trademark Office. The certificate of recordal shall display the recorded insignia of the manufacturer, and state the name, address, legal entity and domicile of the manufacturer, as well as the date of issuance of such certificate. (b) Certificates that were issued prior to June 8, 1999, shall remain in active status and may be maintained in accordance with the provisions of § 280.320 of this subpart, but only if: (1) The certificate is held by a manufacturer, and (2) The fasteners associated with the certificate are fasteners that must bear an insignia pursuant to 15 U.S.C. 5407. | |||
| 15:15:1.2.2.10.12.4.17.5 | 15 | Commerce and Foreign Trade | II | J | 280 | PART 280—FASTENER QUALITY | D | Subpart D—Recordal of Insignia | § 280.313 Recordal of additional insignia. | NIST | [61 FR 50558, Sept. 26, 1996. Redesignated and amended at 65 FR 39803, June 28, 2000] | (a) A manufacturer to whom the Director, USPTO, has issued an alphanumeric designation may apply for recordal of its trademark for fasteners if the trademark is the subject of a duly filed application or is registered in the United States Patent and Trademark Office on the Principal Register. Upon recordal, either the alphanumeric designation or the trademark, or both, may be used as recorded insignias. (b) A manufacturer for whom the Director, USPTO, has recorded a trademark as its fastener insignia may apply for issuance and recordal of an alphanumeric designation as a fastener insignia. Upon recordal, either the alphanumeric designation or the trademark, or both, may be used as recorded insignias. | |||
| 15:15:1.2.2.10.12.4.18.10 | 15 | Commerce and Foreign Trade | II | J | 280 | PART 280—FASTENER QUALITY | D | Subpart D—Recordal of Insignia | § 280.324 Change in status of trademark registration or amendment of the trademark. | NIST | [61 FR 50558, Sept. 26, 1996. Redesignated and amended at 65 FR 39803, 39804, June 28, 2000] | (a) The Director, USPTO, shall designate the certificate of recordal as inactive, upon: (1) Issuance of a final decision on appeal which refuses registration of the application which formed the basis for the certificate of recordal; (2) Abandonment of the application which formed the basis for the certificate of recordal; (3) Cancellation or expiration of the trademark registration which formed the basis of the certificate of recordal; or (4) An amendment of the mark in a trademark application or registration that forms the basis for a certificate of recordal. The certificate of recordal shall become inactive as of the date the amendment is filed. A new application for recordal of the amended trademark application or registration may be submitted to the Commissioner at any time. (b) Certificates of recordal designated inactive due to cancellation, expiration, or amendment of the trademark registration, or abandonment or amendment of the trademark application, cannot be reactivated. | |||
| 15:15:1.2.2.10.12.4.18.11 | 15 | Commerce and Foreign Trade | II | J | 280 | PART 280—FASTENER QUALITY | D | Subpart D—Recordal of Insignia | § 280.325 Cumulative listing of recordal information. | NIST | [65 FR 39804, June 28, 2000] | The Director, USPTO, shall maintain a record of the names, current addresses, and legal entities of all recorded manufacturers and their recorded insignia. | |||
| 15:15:1.2.2.10.12.4.18.12 | 15 | Commerce and Foreign Trade | II | J | 280 | PART 280—FASTENER QUALITY | D | Subpart D—Recordal of Insignia | § 280.326 Records and files of the United States Patent and Trademark Office. | NIST | [61 FR 50558, Sept. 26, 1996. Redesignated and amended at 65 FR 39803, 39804, June 28, 2000] | The records relating to fastener insignia shall be open to public inspection. Copies of any such records may be obtained upon request and payment of the fee set by the Director, USPTO. | |||
| 15:15:1.2.2.10.12.4.18.6 | 15 | Commerce and Foreign Trade | II | J | 280 | PART 280—FASTENER QUALITY | D | Subpart D—Recordal of Insignia | § 280.320 Maintenance of the certificate of recordal. | NIST | [61 FR 50558, Sept. 26, 1996. Redesignated and amended at 65 FR 39803, 39804, June 28, 2000] | (a) Certificates of recordal remain in an active status for five years and may be maintained in an active status for subsequent five-year periods running consecutively from the date of issuance of the certificate of recordal upon compliance with the requirements of paragraph (c) of this section. (b) Maintenance applications shall be required only if the holder of the certificate of recordal is a manufacturer at the time the maintenance application is required. (c) Certificates of recordal will be designated as inactive unless, within six months prior to the expiration of each five-year period running consecutively from the date of issuance, the certificate holder files the prescribed maintenance fee and the maintenance application. The maintenance application must be in the English language and must include the following: (1) The name of the manufacturer; (2) The address of the manufacturer; (3) The entity, domicile, and state of incorporation, if applicable, of the manufacturer; (4) A copy of manufacturer's certificate of recordal; (5) A statement that the manufacturer will comply with the applicable provisions of the Fastener Quality Act; (6) A statement that the applicant for recordal is a “manufacturer” as that term is defined in 15 U.S.C. 5402; (7) A statement that the person signing the application on behalf of the manufacturer has knowledge of the facts relevant to the application and that the person possesses the authority to act on behalf of the manufacturer; (8) A verification stating that the person signing declares under penalty of perjury under the laws of the United States of America that the information and statements included in the application are true and correct; and (9) The maintenance application fee. (d) Where no maintenance application is timely filed, a certificate of recordal will be designated inactive. However, such certificate may be designated active if the certificate holder files the prescribed maintenance fee and application and the additional surcharge within six month… | |||
| 15:15:1.2.2.10.12.4.18.7 | 15 | Commerce and Foreign Trade | II | J | 280 | PART 280—FASTENER QUALITY | D | Subpart D—Recordal of Insignia | § 280.321 Notification of changes of address. | NIST | [61 FR 50558, Sept. 26, 1996. Redesignated and amended at 65 FR 39803, 39804, June 28, 2000] | The applicant for recordal or the holder of a certificate of recordal shall notify the Director, USPTO, of any change of address or change of name no later than six months after the change. The holder must do so whether the certificate of recordal is in an active or inactive status. | |||
| 15:15:1.2.2.10.12.4.18.8 | 15 | Commerce and Foreign Trade | II | J | 280 | PART 280—FASTENER QUALITY | D | Subpart D—Recordal of Insignia | § 280.322 Transfer or amendment of the certificate of recordal. | NIST | [61 FR 50558, Sept. 26, 1996. Redesignated at 65 FR 39803, June 28, 2000] | (a) The certificate of recordal cannot be transferred or assigned. (b) The certificate of recordal may be amended only to show a change of name or change of address. | |||
| 15:15:1.2.2.10.12.4.18.9 | 15 | Commerce and Foreign Trade | II | J | 280 | PART 280—FASTENER QUALITY | D | Subpart D—Recordal of Insignia | § 280.323 Transfer or assignment of the trademark registration or recorded insignia. | NIST | [61 FR 50558, Sept. 26, 1996. Redesignated and amended at 65 FR 39803, 39804, June 28, 2000; 72 FR 30704, June 4, 2007] | (a) A trademark application or registration which forms the basis of a fastener recordal may be transferred or assigned. Any transfer or assignment of such an application or registration must be recorded in the United States Patent and Trademark Office within three months of the transfer or assignment. A copy of such transfer or assignment must also be sent to: Director, United States Patent and Trademark Office, ATTN: FQA, 600 Dulany Street, MDE-10A71, Alexandria, VA 22314-5793. (b) Upon transfer or assignment of a trademark application or registration which forms the basis of a certificate of recordal, the Director, USPTO, shall designate the certificate of recordal as inactive. The certificate of recordal shall be deemed inactive as of the effective date of the transfer or assignment. Certificates of recordal designated inactive due to transfer or assignment of a trademark application or registration cannot be reactivated. (c) An assigned trademark application or registration may form the basis for a new application for recordal of a fastener insignia. (d) A fastener insignia consisting of an alphanumeric designation issued by the Director, USPTO, can be transferred or assigned. (e) Upon transfer or assignment of an alphanumeric designation, the Director, USPTO, shall designate such alphanumeric designation as inactive. The alphanumeric designation shall be deemed inactive as of the effective date of the transfer or assignment. Alphanumeric designations which are designated inactive due to transfer or assignment may be reactivated upon application by the assignee of such alphanumeric designation. Such application must meet all the requirements of § 280.310 and must include a copy of the pertinent portions of the document assigning rights in the alphanumeric designation. Such application must be filed within six months of the date of assignment. (f) An alphanumeric designation that is reactivated after it has been transferred or assigned shall remain in active status until the expiration of the five year p… | |||
| 15:15:1.2.2.10.13.0.19.1 | 15 | Commerce and Foreign Trade | II | J | 285 | PART 285—NATIONAL VOLUNTARY LABORATORY ACCREDITATION PROGRAM | § 285.1 Purpose. | NIST | [85 FR 60060, Sept. 24, 2020] | The purpose of this part is to set out procedures and general requirements under which the National Voluntary Laboratory Accreditation Program (NVLAP) operates as an unbiased third party to accredit both testing and calibration laboratories. Supplementary technical and administrative requirements are provided in supporting handbooks and documents as needed, depending on the criteria established for specific Laboratory Accreditation Programs (LAPs). | |||||
| 15:15:1.2.2.10.13.0.19.10 | 15 | Commerce and Foreign Trade | II | J | 285 | PART 285—NATIONAL VOLUNTARY LABORATORY ACCREDITATION PROGRAM | § 285.10 Renewal of accreditation. | NIST | [66 FR 29221, May 30, 2001, as amended at 85 FR 60060, Sept. 24, 2020] | (a) An accredited laboratory must submit both its application for renewal and fees to NVLAP prior to expiration of the laboratory's current accreditation to avoid a lapse in accreditation. (b) On-site assessments of currently accredited laboratories are performed in accordance with the procedures in § 285.7. If nonconformities are found during the assessment of an accredited laboratory, the laboratory must follow the procedures set forth in § 285.7(e)(2) or face possible suspension or revocation of accreditation. | |||||
| 15:15:1.2.2.10.13.0.19.11 | 15 | Commerce and Foreign Trade | II | J | 285 | PART 285—NATIONAL VOLUNTARY LABORATORY ACCREDITATION PROGRAM | § 285.11 Changes to scope of accreditation. | NIST | A laboratory may request in writing changes to its Scope of Accreditation. If the laboratory requests additions to its Scope, it must meet all NVLAP criteria for the additional tests or calibrations, types of tests or calibrations, or standards. The need for an additional on-site assessment and/or proficiency testing will be determined on a case-by-case basis. | ||||||
| 15:15:1.2.2.10.13.0.19.12 | 15 | Commerce and Foreign Trade | II | J | 285 | PART 285—NATIONAL VOLUNTARY LABORATORY ACCREDITATION PROGRAM | § 285.12 Monitoring visits. | NIST | [85 FR 60060, Sept. 24, 2020] | (a) In addition to regularly scheduled assessments, monitoring visits may be conducted by NVLAP at any time during the accreditation period. They may occur for cause or on a random selection basis. While most monitoring visits will be scheduled in advance with the laboratory, NVLAP may conduct unannounced monitoring visits. (b) The scope of a monitoring visit may range from checking a few designated items to a complete review. The assessors may review nonconformity resolutions, verify reported changes in the laboratory's personnel, facilities or operations, or evaluate proficiency testing activities, when appropriate. | |||||
| 15:15:1.2.2.10.13.0.19.13 | 15 | Commerce and Foreign Trade | II | J | 285 | PART 285—NATIONAL VOLUNTARY LABORATORY ACCREDITATION PROGRAM | § 285.13 Denial, suspension, revocation, or termination of accreditation. | NIST | (a) A laboratory may at any time voluntarily terminate its participation and responsibilities as an accredited laboratory by advising NVLAP in writing of its desire to do so. (b) If NVLAP finds that an accredited laboratory does not meet all NVLAP requirements, has violated the terms of its accreditation, or does not continue to comply with the provisions of these procedures, NVLAP may suspend the laboratory's accreditation, or advise of NVLAP's intent to revoke accreditation. (1) If a laboratory's accreditation is suspended, NVLAP shall notify the laboratory of that action stating the reasons for and conditions of the suspension and specifying the action(s) the laboratory must take to have its accreditation reinstated. Conditions of suspension will include prohibiting the laboratory from using the NVLAP logo on its test or calibration reports, correspondence, or advertising during the suspension period in the area(s) affected by the suspension. (2) NVLAP will not require a suspended laboratory to return its Certificate and Scope of Accreditation, but the laboratory must refrain from using the NVLAP logo in the area(s) affected until such time as the problem(s) leading to the suspension has been resolved. When accreditation is reinstated, NVLAP will authorize the laboratory to resume testing or calibration activities in the previously suspended area(s) as an accredited laboratory. (c) If NVLAP proposes to deny or revoke accreditation of a laboratory, NVLAP shall inform the laboratory of the reasons for the proposed denial or revocation and the procedure for appealing such a decision. (1) The laboratory will have thirty days from the date of receipt of the proposed denial or revocation letter to appeal the decision to the Director of NIST. If the laboratory appeals the decision to the Director of NIST, the proposed denial or revocation will be stayed pending the outcome of the appeal. The proposed denial or revocation will become final through the issuance of a written decision to the laboratory in the event … | ||||||
| 15:15:1.2.2.10.13.0.19.14 | 15 | Commerce and Foreign Trade | II | J | 285 | PART 285—NATIONAL VOLUNTARY LABORATORY ACCREDITATION PROGRAM | § 285.14 Criteria for accreditation. | NIST | [85 FR 60061, Sept. 24, 2020] | The requirements for laboratories to be recognized by the National Voluntary Laboratory Accreditation Program as competent to carry out tests and/or calibrations are contained in NIST Handbook 150, NVLAP Procedures and General Requirements (incorporated by reference, see § 285.16). | |||||
| 15:15:1.2.2.10.13.0.19.15 | 15 | Commerce and Foreign Trade | II | J | 285 | PART 285—NATIONAL VOLUNTARY LABORATORY ACCREDITATION PROGRAM | § 285.15 Obtaining documents. | NIST | [66 FR 29221, May 30, 2001, as amended at 72 FR 36347, July 3, 2007; 85 FR 60061, Sept. 24, 2020] | (a) Application forms, NVLAP handbooks, and other NVLAP documents and information may be obtained by contacting the NVLAP, National Institute of Standards and Technology, 100 Bureau Drive, Mail Stop 2140, Gaithersburg, Maryland 20899-2140; phone: 301-975-4016; fax: 301-926-2884; e-mail: nvlap@nist.gov. (b) Copies of all ISO/IEC documents are available for purchase from the American National Standards Institute's eStandards Store at http://webstore.ansi.org. You may inspect copies of all applicable ISO/IEC documents at the National Voluntary Laboratory Accreditation Program, National Institute of Standards and Technology, 100 Bureau Drive, Room B119, Gaithersburg, MD. For access to the NIST campus, please contact NVLAP by phone at 301-975-4016 or by email at NVLAP@nist.gov to obtain instructions for visitor registration. | |||||
| 15:15:1.2.2.10.13.0.19.16 | 15 | Commerce and Foreign Trade | II | J | 285 | PART 285—NATIONAL VOLUNTARY LABORATORY ACCREDITATION PROGRAM | § 285.16 Incorporation by reference. | NIST | [85 FR 60061, Sept. 24, 2020] | Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved material is available for inspection at National Institute of Standards and Technology, National Voluntary Laboratory Accreditation Program (NVLAP), National Institute of Standards and Technology, 100 Bureau Drive, Room B119, Gaithersburg, MD and is available from the source(s) listed in the following paragraph(s). It is also available for inspection at the National Archives and Records Administration (NARA). For access to the NIST campus, please contact NVLAP by phone at 301-975-4016 or by email at NVLAP@nist.gov to obtain instructions for visitor registration. For information on the availability of this material at NARA, email fedreg.legal@nara.gov or go to www.archives.gov/federal-register/cfr/ibr-locations.html. (a) National Institute of Standards and Technology (NIST), U.S. Department of Commerce, 100 Bureau Drive, Room B119, Gaithersburg, MD, 301-975-4016 NVLAP@nist.gov, www.nist.gov/publications/. (1) NIST Handbook 150, National Voluntary Laboratory Accreditation Program Procedures (NVLAP) and General Requirements, authored by Dana S. Leaman and Bethany Hackett, 2020 Edition, August 2020, 2020 ( NVLAP Procedures and General Requirements ) https://nvlpubs.nist.gov/nistpubs/hb/2020/NIST.HB.150-2020.pdf; into §§ 285.8(a) and § 285.14. (2) [Reserved] (b) [Reserved] | |||||
| 15:15:1.2.2.10.13.0.19.2 | 15 | Commerce and Foreign Trade | II | J | 285 | PART 285—NATIONAL VOLUNTARY LABORATORY ACCREDITATION PROGRAM | § 285.2 Confidentiality. | NIST | To the extent permitted by applicable laws, NVLAP will protect the confidentiality of all information obtained relating to the application, on-site assessment, proficiency testing, evaluation, and accreditation of laboratories. | ||||||
| 15:15:1.2.2.10.13.0.19.3 | 15 | Commerce and Foreign Trade | II | J | 285 | PART 285—NATIONAL VOLUNTARY LABORATORY ACCREDITATION PROGRAM | § 285.3 Referencing NVLAP accreditation. | NIST | The term NVLAP (represented by the NVLAP logo) is a federally registered certification mark of the National Institute of Standards and Technology and the federal government, who retain exclusive rights to control the use thereof. Permission to use the term and/or logo is granted to NVLAP-accredited laboratories for the limited purposes of announcing their accredited status, and for use on reports that describe only testing and calibration within the scope of accreditation. NIST reserves the right to control the quality of the use of the term NVLAP and of the logo itself. | ||||||
| 15:15:1.2.2.10.13.0.19.4 | 15 | Commerce and Foreign Trade | II | J | 285 | PART 285—NATIONAL VOLUNTARY LABORATORY ACCREDITATION PROGRAM | § 285.4 Establishment of laboratory accreditation programs (LAPs) within NVLAP. | NIST | [66 FR 29221, May 30, 2001, as amended at 76 FR 78815, Dec. 20, 2011] | NVLAP establishes LAPs in response to legislative actions or to requests from private sector entities and government agencies. For legislatively mandated LAPs, NVLAP shall establish the LAP. For requests from private sector entities and government agencies, the Chief of NVLAP shall analyze each request, and, after consultation with interested parties through public workshops or other means to ensure open participation, shall establish the requested LAP, if the Chief of NVLAP determines there is need for the requested LAP. | |||||
| 15:15:1.2.2.10.13.0.19.5 | 15 | Commerce and Foreign Trade | II | J | 285 | PART 285—NATIONAL VOLUNTARY LABORATORY ACCREDITATION PROGRAM | § 285.5 Termination of a LAP. | NIST | (a) The Chief of NVLAP may terminate a LAP when he/she determines that a need no longer exists to accredit laboratories for the services covered under the scope of the LAP. In the event that the Chief of NVLAP proposes to terminate a LAP, a notice will be published in the Federal Register setting forth the basis for that determination. (b) When a LAP is terminated, NVLAP will no longer grant or renew accreditations following the effective date of termination. Accreditations previously granted shall remain effective until their expiration date unless terminated voluntarily by the laboratory or revoked by NVLAP. Technical expertise will be maintained by NVLAP while any accreditation remains effective. | ||||||
| 15:15:1.2.2.10.13.0.19.6 | 15 | Commerce and Foreign Trade | II | J | 285 | PART 285—NATIONAL VOLUNTARY LABORATORY ACCREDITATION PROGRAM | § 285.6 Application for accreditation. | NIST | [85 FR 60060, Sept. 24, 2020] | A laboratory may apply for accreditation in any of the established LAPs. The applicant laboratory shall provide a completed application to NVLAP, pay all required fees and agree to certain conditions as set forth in the NVLAP Application for Accreditation, and provide management system documentation to NVLAP (or a designated NVLAP assessor) prior to the assessment process. | |||||
| 15:15:1.2.2.10.13.0.19.7 | 15 | Commerce and Foreign Trade | II | J | 285 | PART 285—NATIONAL VOLUNTARY LABORATORY ACCREDITATION PROGRAM | § 285.7 Assessment. | NIST | [66 FR 29221, May 30, 2001, as amended at 85 FR 60060, Sept. 24, 2020] | (a) Frequency and scheduling. Before initial accreditation, during the first renewal year, and every two years thereafter, an on-site assessment of each laboratory is conducted to determine compliance with the NVLAP criteria. (b) Assessors. NVLAP shall select qualified assessors to evaluate all information collected from an applicant laboratory pursuant to § 285.6 of this part and to conduct the assessment on its behalf at the laboratory and any other sites where activities to be covered by the accreditation are performed. (c) Conduct of assessment. (1) Assessors use checklists provided by NVLAP so that each laboratory receives an assessment comparable to that received by others. (2) During the assessment, the assessor meets with management and laboratory personnel, examines the quality system, reviews staff information, examines equipment and facilities, observes demonstrations of testing or calibrations, and examines tests or calibration reports. (3) The assessor reviews laboratory records including resumes, job descriptions of key personnel, training, and competency evaluations for all staff members who routinely perform, or affect the quality of the testing or calibration for which accreditation is sought. The assessor need not be given information which violates individual privacy, such as salary, medical information, or performance reviews outside the scope of the accreditation program. The staff information may be kept in the laboratory's official personnel folders or separate folders that contain only the information that the NVLAP assessor needs to review. (4) At the conclusion of the assessment, the assessor conducts an exit briefing to discuss observations and any nonconformities with the authorized representative who signed the NVLAP application and other responsible laboratory staff. (d) Assessment report. At the exit briefing, the assessor submits a written report on the compliance of the laboratory with the accreditation requirements, together with the completed checklists, where appr… | |||||
| 15:15:1.2.2.10.13.0.19.8 | 15 | Commerce and Foreign Trade | II | J | 285 | PART 285—NATIONAL VOLUNTARY LABORATORY ACCREDITATION PROGRAM | § 285.8 Proficiency testing. | NIST | [85 FR 60060, Sept. 24, 2020] | (a) Proficiency testing requirements. Proficiency testing undertaken to meet the criteria for NVLAP accreditation shall be consistent with the provisions contained in NIST Handbook 150, NVLAP Procedures and General Requirements (incorporated by reference, see § 285.16), where applicable, including revisions from time to time. Laboratories must participate in proficiency testing as specified for each LAP in the NVLAP program handbooks. (b) Analysis and reporting. Proficiency testing results are analyzed by NVLAP and results of the analysis are made known to the participants. Any result not meeting the criteria specified in the NVLAP LAP program handbook is identified as a nonconformity. (c) Proficiency testing nonconformities. (1) Unsatisfactory participation in any proficiency testing program is a technical nonconformity which must be resolved in order to obtain initial accreditation or maintain accreditation. (2) Proficiency testing nonconformities are defined as, but not limited to, one or more of the following: (i) Failure to meet specified proficiency testing performance requirements prescribed by NVLAP; (ii) Failure to participate in a regularly scheduled “round” of proficiency testing for which the laboratory has received instructions and/or materials; (iii) Failure to submit laboratory control data as required; or (iv) Failure to produce acceptable test or calibration results when using NIST Standard Reference Materials or special artifacts whose properties are well-characterized and known to NIST/NVLAP. (3) NVLAP will notify the laboratory of proficiency testing nonconformities and actions to be taken to resolve the nonconformities. Denial or suspension of accreditation will result from failure to resolve nonconformities. | |||||
| 15:15:1.2.2.10.13.0.19.9 | 15 | Commerce and Foreign Trade | II | J | 285 | PART 285—NATIONAL VOLUNTARY LABORATORY ACCREDITATION PROGRAM | § 285.9 Granting accreditation. | NIST | (a) The Chief of NVLAP is responsible for all NVLAP accreditation actions, including granting, denying, renewing, suspending, and revoking any NVLAP accreditation. (b) Initial accreditation is granted when a laboratory has met all NVLAP requirements. One of four accreditation renewal dates (January 1, April 1, July 1, or October 1) is assigned to the laboratory and is usually retained as long as the laboratory remains in the program. Initial accreditation is granted for a period of one year; accreditation expires and is renewable on the assigned date. (c) Renewal dates may be reassigned to provide benefits to the laboratory and/or NVLAP. If a renewal date is changed, the laboratory will be notified in writing of the change and any related adjustment in fees. (d) When accreditation is granted, NVLAP shall provide to the laboratory a Certificate of Accreditation and a Scope of Accreditation, | ||||||
| 15:15:1.2.2.10.14.0.19.1 | 15 | Commerce and Foreign Trade | II | J | 286 | PART 286—NATIONAL VOLUNTARY CONFORMITY ASSESSMENT SYSTEM EVALUATION (NVCASE) PROGRAM | § 286.1 Purpose. | NIST | The purpose of this program is to enable U.S. industry to satisfy mandated foreign technical requirements using the results of U.S.-based conformity assessment programs that perform technical evaluations comparable in their rigor to practices in the receiving country. Under this program, the Department of Commerce, acting through the National Institute of Standards and Technology, evaluates U.S.-based conformity assessment bodies in order to be able to give assurances to a foreign government that qualifying bodies meet that government's requirements and can provide results that are acceptable to that government. The program is intended to provide a technically-based U.S. approval process for U.S. industry to gain foreign market access; the acceptability of conformity assessment results to the relevant foreign government will be a matter for agreement between the two governments. | ||||||
| 15:15:1.2.2.10.14.0.19.10 | 15 | Commerce and Foreign Trade | II | J | 286 | PART 286—NATIONAL VOLUNTARY CONFORMITY ASSESSMENT SYSTEM EVALUATION (NVCASE) PROGRAM | § 286.10 Appeal. | NIST | Any applicant or other affected party may appeal to the NIST Director any action taken under the program. When appropriate, the Director may seek an independent review by the Deputy Chief Counsel. | ||||||
| 15:15:1.2.2.10.14.0.19.11 | 15 | Commerce and Foreign Trade | II | J | 286 | PART 286—NATIONAL VOLUNTARY CONFORMITY ASSESSMENT SYSTEM EVALUATION (NVCASE) PROGRAM | § 286.11 Listings. | NIST | (a) NIST maintains lists of all bodies holding current NIST program certificates, together with the assessment areas for which they are issued. (b) NIST also maintains lists of those qualified conformity assessment bodies that are currently accredited by bodies recognized by NIST, along with the activities of the assessment bodies within the scope of the NIST recognition program. (c) The lists are made available to the public through various media, e.g., printed directories, electronic bulletin boards, or other means to ensure accessibility by all potential users. (d) With respect to the lists specified in paragraph (a) and (b) of this section, NIST may delist any body if it determines the action to be in the public interest. | ||||||
| 15:15:1.2.2.10.14.0.19.12 | 15 | Commerce and Foreign Trade | II | J | 286 | PART 286—NATIONAL VOLUNTARY CONFORMITY ASSESSMENT SYSTEM EVALUATION (NVCASE) PROGRAM | § 286.12 Terminations. | NIST | (a) Voluntary termination. Any participant may voluntarily terminate participation at any time by written notification to NIST. (b) Involuntary termination. If a participant does not continue to meet all program requirements, or if NIST determines it to be necessary in the public interest, NIST may withdraw that participant's certificate. A body that has had its status as a certificate holder terminated may reapply when prepared to demonstrate full conformance with program requirements. | ||||||
| 15:15:1.2.2.10.14.0.19.2 | 15 | Commerce and Foreign Trade | II | J | 286 | PART 286—NATIONAL VOLUNTARY CONFORMITY ASSESSMENT SYSTEM EVALUATION (NVCASE) PROGRAM | § 286.2 Scope. | NIST | (a) For purposes of this program, conformity assessment consists of product sample testing, product certification, and quality system registration. Associated activities can be classified by level: (1) Conformity level: This level encompasses comparing a product, process, service, or system with a standard or specification. As appropriate, the evaluating body can be a testing laboratory, product certifier or certification body, or quality system registrar. (2) Accreditation level: This level encompasses the evaluation of a testing laboratory, a certification body, or a quality system registrar by an independent body—an accreditation body—based on requirements for the acceptance of these bodies, and the granting of accreditation to those which meet the established requirements. (3) Recognition level: This level encompasses the evaluation of an accreditation body based on requirements for its acceptance, and the recognition by the evaluating body of the accreditation body which satisfies the established requirements. (b) NIST operates the NVCASE program as follows: (1) Conformity level: Under this program NIST accepts requests for evaluations of U.S. bodies involved in activities related to conformity assessment. NIST does not perform conformity assessments as part of the program and therefore does not accept requests for such evaluations. (2) Accreditation level: NIST accepts requests for accreditation of conformity assessment bodies only when (i) directed by U.S. law; (ii) requested by another U.S. government agency; or (iii) requested to respond to a specific U.S. industrial or technical need, relative to a mandatory foreign technical requirement, if it has been determined after public consultation that (A) there is no satisfactory accreditation alternative available and the private sector has declined to make acceptable accreditation available, and (B) there is evidence that significant public disadvantage would result from the absence of any alternative. (3) Recognition level: NIST accepts r… | ||||||
| 15:15:1.2.2.10.14.0.19.3 | 15 | Commerce and Foreign Trade | II | J | 286 | PART 286—NATIONAL VOLUNTARY CONFORMITY ASSESSMENT SYSTEM EVALUATION (NVCASE) PROGRAM | § 286.3 Objective. | NIST | The objective of the program is to identify the activities of requesting U.S.-based conformity assessment bodies that have been evaluated as meeting requirements established for their acceptance by foreign governments. The evaluations may be provided by NIST or by bodies recognized by NIST for this purpose under the scope of this program. | ||||||
| 15:15:1.2.2.10.14.0.19.4 | 15 | Commerce and Foreign Trade | II | J | 286 | PART 286—NATIONAL VOLUNTARY CONFORMITY ASSESSMENT SYSTEM EVALUATION (NVCASE) PROGRAM | § 286.4 Implementation. | NIST | The program is operated on a cost reimbursable basis. It is open for voluntary participation by any U.S.-based body that conducts activities related to conformity assessment falling within the program's scope. A common procedural approach is followed in responding to a request to participate. (See § 286.7 Evaluation process.) All evaluation activities rely on the use of generic program requirements based on standards and guides for the operation and acceptance of activities related to conformity assessment. Specific criteria for use in each evaluation are derived from the program requirements, as appropriate, for the mandated foreign technical requirements specified in the request to participate. A request involving a foreign technical requirement not previously addressed by NVCASE will result in an announcement of NIST's intent to develop evaluation criteria specific to the relevant requirements. NIST will contact all cognizant and interested federal agencies to coordinate appropriate actions and procedures. | ||||||
| 15:15:1.2.2.10.14.0.19.5 | 15 | Commerce and Foreign Trade | II | J | 286 | PART 286—NATIONAL VOLUNTARY CONFORMITY ASSESSMENT SYSTEM EVALUATION (NVCASE) PROGRAM | § 286.5 Program requirements. | NIST | NIST provides and maintains documented generic requirements to be applied in evaluations related to accreditation and recognition within the scope of the program. Available documentation is provided on request to prospective program participants and other interested parties. Generic requirements are developed with public input and are based on guides for the acceptance of conformity assessment activities issued by such international organizations as the International Organization for Standardization and the International Electrotechnical Commission. NIST also provides and maintains documented criteria provided in response to requests for evaluations specific to mandated foreign technical requirements. Criteria are developed with public input derived from the application and interpretation of generic program requirements in relation to specified mandated requirements. Both documented generic requirements and specific criteria are developed and maintained with input from the public. | ||||||
| 15:15:1.2.2.10.14.0.19.6 | 15 | Commerce and Foreign Trade | II | J | 286 | PART 286—NATIONAL VOLUNTARY CONFORMITY ASSESSMENT SYSTEM EVALUATION (NVCASE) PROGRAM | § 286.6 Public consultation. | NIST | NIST relies on substantial advice and technical assistance from all parties interested in program requirements and related specific criteria. Interested U.S. government agencies are routinely to be informed of prospective NVCASE actions, and advice is sought from those agencies on any actions of mutual interest. In preparing program documentation, input is also sought from workshops announced in the Federal Register and open tothe general public and other public means to identify appropriate standards and guides and to develop and maintain generic requirements, based on the identified standards and guides. Where relevant Federal advisory committees are available, their advice may also be sought. Similar procedures will be followed with respect to each request for evaluation which necessitates the development of criteria, derived from the generic requirements, specific to mandated foreign technical requirements. | ||||||
| 15:15:1.2.2.10.14.0.19.7 | 15 | Commerce and Foreign Trade | II | J | 286 | PART 286—NATIONAL VOLUNTARY CONFORMITY ASSESSMENT SYSTEM EVALUATION (NVCASE) PROGRAM | § 286.7 Evaluation process. | NIST | (a) Each applicant requesting to be evaluated under NVCASE is expected to initiate the process and assume designated responsibilities as NIST proceeds with its evaluation: (1) Application. The applicant completes and submit a request to be evaluated. (2) Fee. The applicant submits a partial payment with the application and agrees to submit the remaining balance based on evaluation costs as a condition for satisfactory completion of the process. (3) Documentation. The applicant operates a system and procedures that meet the applicable generic requirements and specific criteria. Relevant documentation submitted with the application is reviewed by NIST. (4) On-site assessment. The applicant and NIST cooperate in the scheduling and conduct of all necessary on-site evaluations, including the resolution of any deficiencies cited. (5) Final review. The applicant provides any supplementary materials requested by NIST, then NIST completes the review and decides on appropriate action. (b) NIST may take one of the following actions with regard to an applicant: (1) Certificate. If an applicant fully demonstrates conformity with all program requirements and specific criteria, NIST issues a certificate documenting this finding. Each certificate is accompanied by a document describing the specific scope of the accreditation or recognition. (2) Denial. If an applicant cannot demonstrate conformity with all program requirements and specific criteria, NIST may deny award of the certificate. An applicant who has failed to complete the evaluation satisfactorily may reapply when prepared to demonstrate full conformance with program requirements. | ||||||
| 15:15:1.2.2.10.14.0.19.8 | 15 | Commerce and Foreign Trade | II | J | 286 | PART 286—NATIONAL VOLUNTARY CONFORMITY ASSESSMENT SYSTEM EVALUATION (NVCASE) PROGRAM | § 286.8 Confidentiality of information. | NIST | All information collected relative to an applicant during an evaluation is maintained as confidential. Information is released only as required under the terms of the Freedom of Information Act or other legal requirement, subject to the rules of the Department of Commerce for such disclosure as found in 15 CFR part 4. | ||||||
| 15:15:1.2.2.10.14.0.19.9 | 15 | Commerce and Foreign Trade | II | J | 286 | PART 286—NATIONAL VOLUNTARY CONFORMITY ASSESSMENT SYSTEM EVALUATION (NVCASE) PROGRAM | § 286.9 Maintaining recognized status. | NIST | Each program participant remaining in the program shall continuously meet all program requirements and cooperate with NIST in the conduct of all surveillance and reassessment activities. Participants shall reimburse NIST for expenses incurred for these purposes. | ||||||
| 15:15:1.2.2.10.15.0.19.1 | 15 | Commerce and Foreign Trade | II | J | 287 | PART 287—GUIDANCE ON FEDERAL CONFORMITY ASSESSMENT | § 287.1 Purpose and scope of this part. | NIST | (a) This part outlines Federal agencies' responsibilities for using conformity assessment to meet respective agency requirements in an efficient and cost-effective manner for the agency and its stakeholders. To reduce unnecessary complexity and make productive use of Federal resources, this part emphasizes that agencies should consider coordinating conformity assessment activities with those of other appropriate government agencies (Federal, State, and local) and with those in the private sector. (b) Using conformity assessment in a manner consistent with this part supports U.S. Government efforts to meet trade obligations and demonstrate good regulatory practices, which reduces unnecessary obstacles to international trade and improves market access for products and services. (c) This part applies to all agencies which set policy for, manage, operate, or use conformity assessment. This part does not preempt the agencies' authority and responsibility to make decisions authorized by statute or required to meet regulatory, procurement, or programmatic objectives and requirements. These decision-making activities include: determining the level of acceptable regulatory or procurement risk; setting the level of protection; balancing risk, cost, and availability of technology and technical resources (where statutes permit) in establishing regulatory, procurement, and program requirements. (d) Each agency retains broad discretion in its selection and use of conformity assessment activities and may elect not to use or recognize alternative conformity assessment approaches if the agency deems the alternatives to be inappropriate, inadequate, or inconsistent with statutory criteria or programmatic objectives and requirements. Nothing contained in this part shall give any party any claim or cause of action against the Federal Government or any agency thereof. Each agency remains responsible for representation of the agency's views on conformity assessment in matters under its jurisdiction. Each agency also remains the pri… | ||||||
| 15:15:1.2.2.10.15.0.19.2 | 15 | Commerce and Foreign Trade | II | J | 287 | PART 287—GUIDANCE ON FEDERAL CONFORMITY ASSESSMENT | § 287.2 Definitions. | NIST | For the purposes of this part: Agency means any Executive Department, independent commission, board, bureau, office, government-owned or controlled corporation, or other establishment of the Federal Government. It also includes any regulatory commission or board, except for independent regulatory commissions insofar as they are subject to separate statutory requirements regarding policy setting, management, operation, and use of conformity assessment. It does not include the legislative or judicial branches of the Federal Government. Agency Standards Executive means an official designated by an agency as its representative on the Interagency Committee for Standards Policy (ICSP) and delegated the responsibility for agency implementation of Office of Management and Budget (OMB) Circular A-119 and the guidance in this part. Conformity assessment is a demonstration, whether directly or indirectly, that specified requirements relating to a product, process, system, person, or body are fulfilled. Requirements for products, services, systems, persons, and organizations are those defined by law or regulation, by an agency in regulatory or procurement actions, or an agency programmatic policy. Conformity assessment does not include mandatory administrative procedures (such as registration notification) for granting permission for a good or service to be produced, marketed, or used for a stated purpose or under stated conditions. Conformity assessment related terminology and concepts, including a discussion of the value and benefits of conformity assessment, are contained in NIST Special Publication 2000-01, ABCs of Conformity Assessment (2018) found free of charge at: https://doi.org/10.6028/NIST.SP.2000-01 and NIST Special Publication 2000-02, Conformity Assessment Considerations for Federal Agencies, found at: https://doi.org/10.6028/NIST.SP.2000-02. The definitions of conformity assessment related terminology included in these documents are based on voluntary consensus standards. See OMB Circular A-119 f… | ||||||
| 15:15:1.2.2.10.15.0.19.3 | 15 | Commerce and Foreign Trade | II | J | 287 | PART 287—GUIDANCE ON FEDERAL CONFORMITY ASSESSMENT | § 287.3 Responsibilities of the National Institute of Standards and Technology. | NIST | (a) Coordinate issues related to agency conformity assessment program development, use, and implementation and issue guidance, training material, and other material to assist Federal agencies in understanding and applying conformity assessment to meet their requirements. Material is available at https://www.standards.gov. (b) Chair the Interagency Committee on Standards Policy (ICSP); encourage participation in the ICSP; as well as provide resource support to the ICSP and its working groups related to conformity assessment issues, as needed. (c) Work with agencies through the ICSP and other means to coordinate Federal, State, and local conformity assessment activities with private sector conformity assessment activities. (d) Participate in the development of voluntary consensus standards, recommendations, and guidelines related to conformity assessment to ensure that Federal viewpoints are represented. (e) Increase awareness of the importance of public and private sector conformity assessment through development and publication of conformity assessment resources. Material is available at https://www.standards.gov. (f) To the extent that resources are available and upon request by a state government agency, work with that state agency to reduce duplication and complexity in state conformity assessment activities. (g) Review, within five years from October 29, 2020, the effectiveness of the guidance in this part and recommend modifications to the Secretary as needed. | ||||||
| 15:15:1.2.2.10.15.0.19.4 | 15 | Commerce and Foreign Trade | II | J | 287 | PART 287—GUIDANCE ON FEDERAL CONFORMITY ASSESSMENT | § 287.4 Responsibilities of Federal agencies. | NIST | Each agency should: (a) Implement the policies contained in the guidance in this part. Agencies may rely on NIST Special Publication 2000-02 Conformity Assessment Considerations for Federal Agencies found free of charge at https://doi.org/10.6028/NIST.SP.2000-02. (b) Develop and implement conformity assessment in a manner that meets regulatory, procurement, and programmatic objectives; reduces unnecessary complexity for stakeholders; makes productive use of Federal resources; and meets international trade agreement obligations. (c) Provide a rationale for its use of specified conformity assessment in rulemaking, procurement actions, and agency programs to the extent feasible. Further, when notice and comment rulemaking is otherwise required, each agency should provide the opportunity for public comment on the rationale for the agency's conformity assessment decision. (d) Work with other Federal agencies to avoid unnecessary duplication and complexity in Federal conformity assessment activities. (e) Consider leveraging the activities and results of other governmental agency and private sector programs in lieu of creating government-unique programs or to enhance the effectiveness of proposed new and existing conformity assessment. (f) Give a preference for using voluntary consensus standards, guides, and recommendations related to conformity assessment in agency operations. Each agency retains responsibility for determining which, if any, of these documents are relevant to its needs. See OMB Circular A-119 for a description of voluntary consensus standards and recommendations for their development and use by Federal agencies. (g) Participate, as needed, representing agency and Federal viewpoints, in efforts to develop voluntary consensus standards, guideline, and recommendations related to conformity assessment. (h) Participate, as needed, representing agency and Federal viewpoints in efforts designed to improve coordination among governmental and private sector conformity assessment activities. (i) Wor… | ||||||
| 15:15:1.2.2.10.15.0.19.5 | 15 | Commerce and Foreign Trade | II | J | 287 | PART 287—GUIDANCE ON FEDERAL CONFORMITY ASSESSMENT | § 287.5 Responsibilities of Agency Standards Executives. | NIST | Each Agency Standards Executive should: (a) Carry out the duties in OMB Circular A-119 related to conformity assessment activities. (b) Encourage effective use of agency conformity assessment related resources. (c) Provide ongoing assistance and policy guidance to the agency on significant issues in conformity assessment. (d) Contribute to the development and dissemination of: (1) Internal agency policies related to conformity assessment issues; and (2) Agency positions on conformity assessment related issues that are in the public interest. (e) Work with other parts of the agency to develop and implement improvements in agency conformity assessment activities. (f) Participate in the Interagency Committee on Standards Policy (ICSP) as the agency representative and member. (g) Promote agency participation in ICSP working groups related to conformity assessment issues, as needed. (h) Encourage agency participation in efforts related to the development of voluntary consensus standards, recommendations, and guidelines related to conformity assessment consistent with agency missions, authorities, priorities, and resources. (i) Establish an ongoing process for reviewing the agency's conformity assessment programs and identify areas where efficiencies can be achieved through coordination within the agency and among other agencies and private sector conformity assessment activities. | ||||||
| 15:15:1.2.2.11.16.0.19.1 | 15 | Commerce and Foreign Trade | II | K | 290 | PART 290—REGIONAL CENTERS FOR THE TRANSFER OF MANUFACTURING TECHNOLOGY | § 290.1 Purpose. | NIST | This rule provides policy for a program to establish Regional Centers for the Transfer of Manufacturing Technology as well as the prescribed policies and procedures to insure the fair, equitable and uniform treatment of proposals for assistance. In addition, the rule provides general guidelines for the management of the program by the National Institute of Standards and Technology, as well as criteria for the evaluation of the Centers, throughout the lifecycle of financial assistance to the Centers by the National Institute of Standards and Technology. | ||||||
| 15:15:1.2.2.11.16.0.19.2 | 15 | Commerce and Foreign Trade | II | K | 290 | PART 290—REGIONAL CENTERS FOR THE TRANSFER OF MANUFACTURING TECHNOLOGY | § 290.2 Definitions. | NIST | (a) The phrase advanced manufacturing technology refers to new technologies which have recently been developed, or are currently under development, for use in product or part design, fabrication, assembly, quality control, or improving production efficiency. (b) The term Center or Regional Center means a NIST-established Regional Center for the Transfer of Manufacturing Technology described under these procedures. (c) The term operating award means a cooperative agreement which provides funding and technical assistance to a Center for purposes set forth in § 290.3 of these procedures. (d) The term Director means the Director of the National Institute of Standards and Technology. (e) The term NIST means the National Institute of Standards and Technology, U.S. Department of Commerce. (f) The term Program or Centers Program means the NIST program for establishment of, support for, and cooperative interaction with Regional Centers for the Transfer of Manufacturing Technology. (g) The term qualified proposal means a proposal submitted by a nonprofit organization which meets the basic requirements set forth in § 290.5 of these procedures. (h) The term Secretary means the Secretary of Commerce. (i) The term target firm means those firms best able to absorb advanced manufacturing technologies and techniques, especially those developed at NIST, and which are already well prepared in an operational, management and financial sensse to improve the levels of technology they employ. | ||||||
| 15:15:1.2.2.11.16.0.19.3 | 15 | Commerce and Foreign Trade | II | K | 290 | PART 290—REGIONAL CENTERS FOR THE TRANSFER OF MANUFACTURING TECHNOLOGY | § 290.3 Program description. | NIST | (a) The Secretary, acting through the Director, shall provide technical and financial assistance for the creation and support of Regional Centers for the Transfer of Manufacturing Technology. Each Center shall be affiliated with a U.S.-based nonprofit institution or organization which has submitted a qualified proposal for a Center Operating Award under these procedures. Support may be provided for a period not to exceed six years. The Centers work with industry, universities, nonprofit economic development organizations and state governments to transfer advanced manufacturing technologies, processes, and methods as defined in § 290.2 to small and medium sized firms. These technology transfer efforts focus on the continuous and incremental improvement of the target firms. The advanced manufacturing technology which is the focus of the Centers is the subject of research in NIST's Automated Manufacturing Research Facility (AMRF). The core of AMRF research has principally been applied in discrete part manufacturing, including electronics, composites, plastics, and metal parts fabrication and assembly. Centers will be afforded the opportunity for interaction with the AMRF and will be given access to reasearch projects and results to strengthen their technology transfer. Where elements of a solution are available from an existing source, they should be employed. Where private-sector consultants who can meet the needs of a small- or medium-sized manufacturer are available, they should handle the task. Each Center should bring to bear the technology expertise described in § 290.3(d) to assist small- and medium-sized manufacturing firms in adopting advanced manufacturing technology. (b) Program objective. The objective of the NIST Manufacturing Technology Centers is to enhance productivity and technological performance in United States manufacturing. This will be accomplished through: (1) The transfer of manufacturing technology and techniques developed at NIST to Centers and, through them, to manufacturing companies… | ||||||
| 15:15:1.2.2.11.16.0.19.4 | 15 | Commerce and Foreign Trade | II | K | 290 | PART 290—REGIONAL CENTERS FOR THE TRANSFER OF MANUFACTURING TECHNOLOGY | § 290.4 Terms and schedule of financial assistance. | NIST | [82 FR 28995, June 27, 2017] | The Secretary may provide up to 50 percent of the capital and annual operating and maintenance funds required to establish and support an MEP Center. | |||||
| 15:15:1.2.2.11.16.0.19.5 | 15 | Commerce and Foreign Trade | II | K | 290 | PART 290—REGIONAL CENTERS FOR THE TRANSFER OF MANUFACTURING TECHNOLOGY | § 290.5 Basic proposal qualifications. | NIST | (a) NIST shall designate each proposal which satisfies the qualifications criteria below as “qualified proposal” and subject the qualified proposals to a merit review. Applications which do not meet the requirements of this section will not receive further consideration. (1) Qualified organizations. Any nonprofit institution, or group thereof, or consortium of nonprofit institutions, including entities which already exist or may be incorporated specifically to manage the Center. (2) Proposal format. Proposals for Center Operating Awards shall: (i) Be submitted with a Standard Form 424 to the above address; (ii) Not exceed 25 typewritten pages in length for the basic proposal document (which must include the information requirements of paragraph (a)(3) of this section); it may be accompanied by additional appendices of relevant supplementary attachments and tabular material. Basic proposal documents which exceed 25 pages in length will not be qualified for further review. (3) Proposal requirements. In order to be considered for a Center Operating Award, proposals must contain: (i) A plan for the allocation of intellectual property rights associated with any invention or copyright which may result from the involvement in the Center's technology transfer or research activities consistent with the conditions of § 290.9; (ii) A statement which provides adequate assurances that the host organization will contribute 50 percent or more of the proposed Center's capital and annual operating and maintenance costs for the first three years and an increasing share for each of the following three additional years. Applicants should provide evidence that the proposed Center will be self-supporting after six years. (iii) A statement describing linkages to industry, government, and educational organizations within its service region. (iv) A statement defining the initial service region including a statement of the constituency to be served and the level of service to be provided, as well as outyear plans. (v) A … | ||||||
| 15:15:1.2.2.11.16.0.19.6 | 15 | Commerce and Foreign Trade | II | K | 290 | PART 290—REGIONAL CENTERS FOR THE TRANSFER OF MANUFACTURING TECHNOLOGY | § 290.6 Proposal evaluation and selection criteria. | NIST | (a) In making a decision whether to provide financial support, NIST shall review and evaluate all qualified proposals in accordance with the following criteria, assigning equal weight to each of the four categories. (1) Identification of target firms in proposed region. Does the proposal define an appropriate service region with a large enough population of target firms of small- and medium-sized manufacturers which the applicant understands and can serve, and which is not presently served by an existing Center? (i) Market analysis. Demonstrated understanding of the service region's manufacturing base, including business size, industry types, product mix, and technology requirements. (ii) Geographical location. Physical size, concentration of industry, and economic significance of the service region's manufacturing base. Geographical diversity of Centers will be a factor in evaluation of proposals; a proposal for a Center located near an existing Center may be considered only if the proposal is unusually strong and the population of manufacturers and the technology to be addressed justify it. (2) Technology resources. Does the proposal assure strength in technical personnel and programmatic resources, full-time staff, facilities, equipment, and linkages to external sources of technology to develop and transfer technologies related to NIST research results and expertise in the technical areas noted in these procedures? (3) Technology delivery mechanisms. Does the proposal clearly and sharply define an effective methodology for delivering advanced manufacturing technology to small- and medium-sized manufacturers? (i) Linkages. Development of effective partnerships or linkages to third parties such as industry, universities, nonprofit economic organizations, and state governments who will amplify the Center's technology delivery to reach a large number of clients in its service region. (ii) Program leverage. Provision of an effective strategy to amplify the Center's technology delivery approache… | ||||||
| 15:15:1.2.2.11.16.0.19.7 | 15 | Commerce and Foreign Trade | II | K | 290 | PART 290—REGIONAL CENTERS FOR THE TRANSFER OF MANUFACTURING TECHNOLOGY | § 290.7 Proposal selection process. | NIST | [86 FR 56183, Oct. 8, 2021] | Upon the availability of funding to solicit applications to establish a new Manufacturing Extension Partnership (MEP) Center or to operate a pre-existing MEP Center, the Director shall publish a notice of funding opportunity on www.Grants.gov requesting submission of competitive proposals from eligible organizations. | |||||
| 15:15:1.2.2.11.16.0.19.8 | 15 | Commerce and Foreign Trade | II | K | 290 | PART 290—REGIONAL CENTERS FOR THE TRANSFER OF MANUFACTURING TECHNOLOGY | § 290.8 Reviews of centers. | NIST | (a) Overview. Each Center will be reviewed at least annually, and at the end of its third year of operation according to the procedures and criteria set out below. There will be regular management interaction with NIST and the other Centers for the purpose of evaluation and program shaping. Centers are encouraged to try new approaches, must evaluate their effectiveness, and abandon or adjust those which do not have the desired impact. (b) Annual reviews of centers. Centers will be reviewed annually as part of the funding renewal process using the criteria set out in § 290.8(d). The funding level at which a Center is renewed is contingent upon a positive program evaluation and will depend upon the availability of federal funds and on the Center's ability to obtain suitable match, as well as on the budgetary requirements of its proposed program. Centers must continue to demonstrate that they will be self-supporting after six years. (c) Third year review of centers. Each host receiving a Center Operating Award under these procedures shall be evaluated during its third year of operation by a Merit Review Panel appointed by the Secretary of Commerce. Each such Merit Review Panel shall be composed of private experts, none of whom shall be connected with the involved Center, and Federal officials. An official of NIST shall chair the panel. Each Merit Review Panel shall measure the involved Center's performance against the criteria set out in § 290.8(d). The Secretary shall not provide funding for the fourth through the sixth years of such Center's operation unless the evaluation is positive on all grounds. As a condition of receiving continuing funding, the Center must show evidence at the third year review that they are making substantial progress toward self-sufficiency. If the evaluation is positive and funds are available, the Secretary of Commerce may provide continued funding through the sixth year at declining levels, which are designed to insure that the Center no longer needs financial support from NIST… | ||||||
| 15:15:1.2.2.11.16.0.19.9 | 15 | Commerce and Foreign Trade | II | K | 290 | PART 290—REGIONAL CENTERS FOR THE TRANSFER OF MANUFACTURING TECHNOLOGY | § 290.9 Intellectual property rights. | NIST | (a) Awards under the Program will follow the policies and procedures on ownership to inventions made under grants and cooperative agreements that are set out in Public Law 96-517 (35 U.S.C. chapter 18), the Presidential Memorandum on Government Patent Policy to the Heads of Executive Departments and Agencies Dated February 18, 1983, and part 401 of title 37 of the Code of Federal Regulations, as appropriate. These policies and procedures generally require the Government to grant to Centers selected for funding the right to elect to obtain title to any invention made in the course of the conduct of research under an award, subject to the reservation of a Government license. (b) Except as otherwise specifically provided for in an Award, Centers selected for funding under the Program may establish claim to copyright subsisting in any data first produced in the performance of the award. When claim is made to copyright, the funding recipient shall affix the applicable copyright notice of 17 U.S.C. 401 or 402 and acknowledgment of Government sponsorship to the data when and if the data are delivered to the Government, are published, or are deposited for registration as a published work in the U.S. Copyright Office. For data other than computer software, the funding recipient shall grant to the Government, and others acting on its behalf, a paid up, nonexclusive, irrevocable, worldwide license for all such data to reproduce, prepare derivative works, distribute copies to the public, and perform publicly and display publicly, by or on behalf of the Government. For computer software, the funding recipient shall grant to the Government, and others acting on its behalf, a paid up, nonexclusive, irrevocable, worldwide license for all such computer software to reproduce, prepare derivative works, distribute copies to the public, and perform publicly and display publicly, by or on behalf of the Government. | ||||||
| 15:15:1.2.2.11.17.0.19.1 | 15 | Commerce and Foreign Trade | II | K | 291 | PART 291—MANUFACTURING EXTENSION PARTNERSHIP; ENVIRONMENTAL PROJECTS | § 291.1 Program description. | NIST | (a) In accordance with the provisions of the National Institute of Standards and Technology Act (15 U.S.C. § 272(b)(1) and (c)(3) and § 2781), as amended, NIST will provide financial assistance to integrate environmentally-related services and resources into the national manufacturing extension system. This assistance will be provided by NIST often in cooperation with the EPA. Under the NIST Manufacturing Extension Partnership (MEP), NIST will periodically make merit-based awards to existing MEP manufacturing extension affiliates for integration of environmental services into extension centers and to non-profit organizations for development of environmentally-related tools and techniques. In addition, NIST will initiate pilot centers providing environmental information for specific industrial sectors to be specified in solicitations. MEP assumes a broad definition of manufacturing, and recognizes a wide range of technology and concepts, including durable goods production; chemical, biotechnology, and other materials processing; electronic component and system fabrication; and engineering services associated with manufacturing, as lying within the definition of manufacturing. (b) Announcements of solicitations. Announcements of solicitations will be made in the Commerce Business Daily. Specific information on the level of funding available and the deadline for proposals will be contained in that announcement. In addition, any specific industry sectors or types of tools and techniques to be focused on will be specified in the announcement. (c) Proposal workshops. Prior to an announcement of solicitation, NIST may announce opportunities for potential applicants to learn about these projects through workshops. The time and place of the workshop(s) will be contained in a Commerce Business Daily announcement. (d) Indirect costs. The total dollar amount of the indirect costs proposed in an application under this program must not exceed the indirect cost rate negotiated and approved by a cognizant Federal agency… | ||||||
| 15:15:1.2.2.11.17.0.19.2 | 15 | Commerce and Foreign Trade | II | K | 291 | PART 291—MANUFACTURING EXTENSION PARTNERSHIP; ENVIRONMENTAL PROJECTS | § 291.2 Environmental integration projects. | NIST | (a) Eligibility criteria. Eligible applicants for these projects are manufacturing extension centers or state technology extension programs which at the time of solicitation have grants, cooperative agreements or contracts with the NIST Manufacturing Extension Partnership. Only one proposal per organization per solicitation is permitted in this category. (b) Project objective. The purpose of these projects is to support the integration of environmentally-focused technical assistance, and especially pollution prevention assistance, for smaller manufacturers into the broader services provided by existing MEP manufacturing extension centers. Proposers are free to structure their project in whatever way will be most effective and efficient in increasing the ability of the center to deliver high quality environmental and pollution prevention technical assistance (either directly or in partnership with other organizations). Following are some examples of purposes for which these funds could be used. This list is by no means meant to be all inclusive. A center might propose a set of actions encompassing several of these examples as well as others. (1) Environmental needs assessment. Detailed assessment of the environmentally-related technical assistance needs of manufacturers within the state or region of the manufacturing extension center. This would be done as part of a broader plan to incorporate environmentally related services into the services of the manufacturing extension center. The center might propose to document its process and findings so that other centers may learn from its work. (2) Partnership with another organization. The center might propose to partner with an existing organization which is providing environmentally-focused technical assistance to manufacturers. The partnership would lead to greater integration of service delivery through joint technical assistance projects and joint training. (3) Accessing private-sector environmental resources. The center might propose to increase it'… |
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