Subpart C-Bonding and § 1005.20 Hearing. (a) If, from an examination of the sample or otherwise, it appears that the product may be subject to a refusal of admission, the Secretary shall give the owner or consignee a written notice to that effect, stating the reasons therefor. The notice shall specify a place and a period of time during which the owner or consignee shall have an opportunity to introduce testimony unless the owner or consignee indicates his intention to bring the product into compliance. Upon timely request, such time and place may be changed. Such testimony shall be confined to matters relevant to the admissibility of the article and may be introduced orally or in writing. (b) If the owner or consignee submits or indicates his intention to submit an application for permission to perform such action as is necessary to bring the product into compliance with the Act, such application shall include the information required by § 1005.21. (c) If the application is not submitted at or prior to the hearing, the Secretary may allow a reasonable time for filing such application. § 1005.21 Application for permission to bring product into compliance. Application for permission to perform such action as is necessary to bring the product into compliance with the Act may be filed only by the owner, consignee, or manufacturer and, in addition to any other information which the Secretary may reasonably require, shall: (a) Contain a detailed proposal for bringing the product into compliance with the Act; (b) Specify the time and place where such operations will be effected and the approximate time for their completion; and (c) Identify the bond required to be filed pursuant to § 1005.23. § 1005.22 Granting permission to bring product into compliance. (a) When permission contemplated by §1005.21 is granted, the Secretary shall notify the applicant in writing, specifying: (1) The procedure to be followed; (2) The disposition of the rejected articles or portions thereof; (3) That the operations are to be carried out under the supervision of a representative of the Department of Health and Human Services; (4) A reasonable time limit for completing the operations; and (5) Such other conditions as he finds necessary to maintain adequate supervision and control over the product. (b) Upon receipt of a written request for an extension of time to complete the operations necessary to bring the product into compliance, the Secretary may grant such additional time as he deems necessary. (c) The notice of permission may be amended upon a showing of reasonable grounds thereof and the filing of an amended application for permission with the Secretary. (d) If ownership of a product included in a notice of permission changes before the operations specified in the notice have been completed, the original owner will remain responsible under its bond, unless the new owner has executed a superseding bond on customs Form 7601 and obtained a new notice. (e) The Secretary will notify the District Director of Customs having jurisdiction over the shipment involved, of the determination as to whether or not the product has in fact been brought into compliance with the Act. § 1005.23 Bonds. The bond required under section 360(b) of the Act shall be executed by the owner or consignee on the appropriate form of a customs single-entry bond, customs Form 7551 or term bond, customs Form 7553 or 7595, containing a condition for the redelivery of the shipment or any part thereof not complying with the laws and regulations governing its admission into the commerce of the United States upon demand of the District Director of Customs and containing a provision for the performance of any action necessary to bring the product into compliance with all applicable laws and regulations. The bond shall be filed with the District Director of Customs. §1005.24 Costs of bringing product into compliance. The costs of supervising the operations necessary to bring a product into compliance with the Act shall be paid by the owner or consignee who files an application pursuant to § 1005.21 and executes a bond under section 360(b) of the Act. Such costs shall include: (a) Travel expenses of the supervising officer; (b) Per diem in lieu of subsistence of the supervising officer when away from his home station, as provided by law; (c) Service fees: (1) The charge for the services of the supervising officer, which shall include administrative support, shall be computed at a rate per hour equal to 266 percent of the hourly rate of regular pay of a grade GS-11/4 employee, except that such services performed by a customs officer and subject to the provisions of the act of February 13, 1911, as amended (sec. 5, 36 Stat. 901, as amended (19 U.S.C. 267)), shall be calculated as provided in that act. (2) The charge for the services of the analyst, which shall include administrative and laboratory support, shall be computed at a rate per hour equal to 266 percent of the hourly rate of regular pay of a grade GS-12/4 employee. (3) The rate per hour equal to 266 percent of the equivalent hourly rate of regular pay of the supervising officer (GS-11/4) and the analyst (GS-12/4) is computed as follows: NOTE: Ratio of equivalent gross annual number of working hours charged to Food and Drug appropriation to net number of annual working hours (4512/1696)=266 pct. (d) The minimum charge for services of supervising officers shall be not less than the charge for 1 hour and time after the first hour shall be computed in multiples of 1 hour, disregarding fractional parts less than one-half hour. [38 FR 28630, Oct. 15, 1973, as amended at 42 FR 55207, Oct. 14, 1977; 42 FR 62130, Dec. 9, 1977] § 1005.25 Service of process on manufacturers. (a) Every manufacturer of electronic products, prior to offering such product for importation into the United States, shall designate a permanent resident of the United States as the manufacturer's agent upon whom service of all processes, notices, orders, decisions, and requirements may be made for and on behalf of the manufacturer as provided in section 360(d) of the Radiation Control for Health and Safety Act of 1968 (42 U.S.C. 263h(d)) and this section. The agent may be an individual, a firm, or a domestic corporation. For purposes of this section, any number of manufacturers may designate the same agent. (b) A manufacturer designating an agent must address the designation to the Center for Devices and Radiological Health, 9200 Corporate Blvd., Rockville, MD 20850. It must be in writing and dated; all signatures must be in ink. The designation must be made in the legal form required to make it valid and binding on the manufacturer under the laws, corporate bylaws, or other requirements governing the making of the designation by the manufacturer at the place and time where it is made, and the persons or person signing the designation shall certify that it is so made. The designation must disclose the manufacturer's full legal name and the name(s) under which the manufacturer conducts the business, if applicable, the principal place of business, and mailing address. If any of the products of the manufacturer do not bear his legal name, the designation must identify the marks, trade names, or other designations of origin which these products bear. The designation must provide that it will remain in effect until withdrawn or replaced by the manufacturer and shall bear a declaration of acceptance duly signed by the designated agent. The full legal name and mailing address of the agent must be stated. Until rejected by the Secretary, designations are binding on the manufacturer even when not in compliance with all the requirements of this section. The designated agent may not assign performance of his function under the designation to another. (c) Service of any process, notice, order, requirement, or decision specified in section 360(d) of the Radiation Control for Health and Safety Act of 1968 may be made by registered or certified mail addressed to the agent with return receipt requested, or in any other manner authorized by law. In the absence of such a designation or if for any reason service on the designated agent cannot be effected, service may be made as provided in section 360(d) by posting such process, notice, order, requirement, or decision in the Office of the Director, Center for Devices and Radiological Health and publishing a notice that such service was made in the FEDERAL REGISTER. [38 FR 28630, Oct. 15, 1973, as amended at 53 FR 11254, Apr. 6, 1988; 65 FR 17137, Mar. 31, 2000] Subpart C-Exportation of Electronic Products 1010.20 Electronic products intended for export. AUTHORITY: 21 U.S.C. 351, 352, 360, 360e-360j, 371, 381; 42 U.S.C. 263b-263n. SOURCE: 38 FR 28631, Oct. 15, 1973, unless otherwise noted. Subpart A-General Provisions § 1010.1 Scope. The standards listed in this subchapter are prescribed pursuant to section 358 of the Radiation Control for Health and Safety Act of 1968 (42 U.S.C. 263f) and are applicable to electronic products as specified herein, to control electronic product radiation from such products. Standards so prescribed are subject to amendment or revocation and additional standards may be prescribed as are determined necessary for the protection of the public health and safety. [40 FR 32257, July 31, 1975] (a) Every manufacturer of an electronic product for which an applicable standard is in effect under this subchapter shall furnish to the dealer or distributor, at the time of delivery of such product, the certification that such product conforms to all applicable standards under this subchapter. (b) The certification shall be in the form of a label or tag permanently affixed to or inscribed on such product so as to be legible and readily accessible to view when the product is fully assembled for use, unless the applicable standard prescribes some other manner of certification. All such labels or tags shall be in the English language. (c) Such certification shall be based upon a test, in accordance with the standard, of the individual article to which it is attached or upon a testing program which is in accordance with good manufacturing practices. The Director, Center for Devices and Radiological Health may disapprove such a testing program on the grounds that it does not assure the adequacy of safeguards against hazardous electronic product radiation or that it does not assure that electronic products comply with the standards prescribed under this subchapter. (d) In the case of products for which it is not feasible to certify in accordance with paragraph (b) of this section, upon application by the manufacturer, the Director, Center for Devices and Radiological Health may approve an alternate means by which such certification may be provided. [38 FR 28631, Oct. 15, 1973, as amended at 40 FR 32257, July 31, 1975; 42 FR 18063, Apr. 5, 1977; 53 FR 11254, Apr. 6, 1988] § 1010.3 Identification. (a) Every manufacturer of an electronic product to which a standard under this subchapter is applicable shall set forth the information specified in paragraphs (a)(1) and (2) of this section. This information shall be provided in the form of a tag or label permanently affixed or inscribed on such product so as to be legible and readily accessible to view when the product is fully assembled for use or in such other manner as may be prescribed in the applicable standard. Except for foreign equivalent abbreviations as authorized in paragraph (a)(1) of this section all such labels or tags shall be in the English language. (1) The full name and address of the manufacturer of the product; abbreviations such as "Co.," "Inc.," or their foreign equivalents and the first and middle initials of individuals may be used. Where products are sold under a name other than that of the manufacturer of the product, the full name and address of the individual or company under whose name the product was sold may be set forth, provided such individual or company has previously suppled the Director, Center for Devices and Radiological Health with sufficient information to identify the manufacturer of the product. (2) The place and month and year of manufacture: (i) The place of manufacture may be expressed in code provided the manufacturer has previously supplied the Director, Center for Devices and Radiological Health with the key to such code. (ii) The month and year of manufacture shall be provided clearly and leg ibly, without abbreviation, and with the year shown as a four-digit number as follows: MANUFACTURED: (INSERT MONTH AND YEAR OF MANUFACTURE.) (b) In the case of products for which it is not feasible to affix identification labeling in accordance with paragraph (a) of this section, upon application by the manufacturer, the Director, Center for Devices and Radiological Health may approve an alternate means by which such identification may be provided. (c) Every manufacturer of an electronic product to which a standard under this subchapter is applicable shall provide to the Director, Center for Devices and Radiological Health a list identifying each brand name which is applied to the product together with the full name and address of the individual or company for whom each product so branded is manufactured. [40 FR 32257, July 31, 1975, as amended at 42 FR 18063, Apr. 5, 1977; 53 FR 11254, Apr. 6, 1988] § 1010.4 Variances. (a) Criteria for variances. (1) Upon application by a manufacturer (including an assembler), the Director, Center for Devices and Radiological Health, Food and Drug Administration, may grant a variance from one or more provisions of any performance standard under subchapter J of this chapter for an electronic product subject to such standard when the Director determines that granting such a variance is in keeping with the purposes of the Radiation Control for Health and Safety Act of 1968, and: (i) The scope of the requested variance is so limited in its applicability as not to justify an amendment to the standard, or (ii) There is not sufficient time for the promulgation of an amendment to the standard. (2) The issuance of the variance shall be based upon a determination that: (i) The product utilizes an alternate means for providing radiation safety or protection equal to or greater than that provided by products meeting all requirements of the applicable standard, or (ii) The product performs a function or is intended for a purpose which could not be performed or accomplished if required to meet the applicable standards, and suitable means for assuring radiation safety or protection are provided, or (iii) One or more requirements of the applicable standard are not appropriate, and suitable means for assuring radiation safety or protection are provided. (b) Applications for variances. If you are submitting an application for variances or for amendments or extensions thereof, you must submit an original and two copies to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. (1) The application for variance shall include the following information: (i) A description of the product and its intended use. (ii) An explanation of how compliance with the applicable standard would restrict or be inappropriate for this intended use. (iii) A description of the manner in which it is proposed to deviate from the requirements of the applicable standard. (iv) A description of the advantages to be derived from such deviation. (v) An explanation of how alternate or suitable means of radiation protection will be provided. (vi) The period of time it is desired that the variance be in effect, and, if appropriate, the number of units the applicant wishes to manufacture. (vii) In the case of prototype or experimental equipment, the proposed location of each unit. (viii) Such other information required by regulation or by the Director, Center for Devices and Radiological Health, to evaluate and act on the application. (ix) With respect to each nonclinical laboratory study contained in the application, either a statement that the study was conducted in compliance with the good laboratory practice regulations set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance. (x) [Reserved] (xi) If the electronic product is used in a clinical investigation involving human subjects, is subject to the requirements for institutional review set forth in part 56 of this chapter, and is subject to the requirements for informed consent set forth in part 50 of this chapter, the investigation shall be conducted in compliance with such requirements. (2) The application for amendment or extension of a variance shall include the following information: (i) The variance number and expiration date. (ii) The amendment or extension requested and basis for the amendment or extension. (iii) A description of the effect of the amendment or extension on protection from radiation produced by the product. (iv) An explanation of how alternate or suitable means of protection will be provided. (c) Ruling on applications. (1) The Director, Center for Devices and Radiological Health, may approve or deny, in whole or in part, a requested variance or any amendment or extension thereof, and the director shall inform the applicant in writing of this action on a requested variance or amendment or extension. The written notice will state the manner in which the variance differs from the standard, the effective date and the termination date of the variance, a summary of the requirements and conditions attached to the variance, any other information that may be relevant to the application or variance, and, if appropriate, the number of units or other similar limitations for which the variance is approved. Each variance will be assigned an identifying number. (2) The Director, Center for Devices and Radiological Health, shall amend or withdraw a variance whenever the Director determines that this action is necessary to protect the public health or otherwise is justified by this subchapter. Such action will become effective on the date specified in the written notice of the action sent to the applicant, except that it will become effective immediately upon notification |