Section 22-B10848. EXEMPTIONS FOR PRODUCTS INTENDED FOR UNITED STATES GOVERNMENT USE

 

10848.1Upon application by a manufacturer (including the assembler), the Department may grant an exemption from any performance standard for an electronic product, or class of products, otherwise subject to such standard when the Department determines that such electronic product or class is intended for use by departments or agencies of the U.S. and meets the criteria set forth in § 10848.2 or § 10848.3.

 

10848.2The procuring agency shall prescribe procurement specifications for the product or class of products governing emissions of electronic product radiation, and the product or class shall be of a type used solely or predominantly by a department or agency of the U.S.

 

10848.3The product or class of products is intended for research, investigations, studies, demonstration, training, or for reasons of national security.

 

10848.4The U.S. department or agency that intends to procure or manufacture a product or class of products subject to electronic product radiation safety standards contained in this chapter should consult with the Department whenever it is anticipated that the specifications for the product or class must deviate from, or be in conflict with, such applicable standards. Such consultation should occur as early as possible during development of such specifications. The department or agency should include in the specifications all requirements of such standards that are not  in conflict with, or are not inappropriate for, the special or unique uses for which the product is intended. The procuring agency should indicate to the Department if it desires to be notified of the approval, amendment, or withdrawal of the exemption.

 

10848.5If you are submitting an application for exemption, or for amendment or extension thereof, you must submit an original and two copies to the Department. For an exemption under the criteria prescribed in § 10848.2 of this section, the application shall include the information prescribed in § 10848.6(a) through (m) of this section. For an exemption under the criteria prescribed in § 10848.3 of this section, the application shall include the information prescribed in § 10848.6(c) through (m). An application for exemption, or for amendment or extension thereof, and correspondence relating to such application shall be made available for public disclosure, except for confidential or proprietary information.

 

10848.6Information classified for reasons of national security shall not be included in the application. Except as indicated in this section, the application for exemption shall include the following:

 

(a) The procurement specifications for the product or class of products that govern emissions of electronic product radiation;

 

(b) Evidence that the product or class of products is of a type used solely or predominantly by departments or agencies of the U.S.;

 

(c) Evidence that such product or class of products is intended for use by a department or agency of the U.S.;

 

(d) A description of the product or class of products and its intended use;

 

(e) An explanation of how compliance with the applicable standard would restrict or be inappropriate for this intended use;

 

(f)A description of the manner in which it is proposed that the product or class of products shall deviate from the requirements of the applicable standard;
 

(g)An explanation of the advantages to be derived from such deviation;
 

(h)An explanation of how means of radiation protection will be provided where the product or class of products deviates from the requirements of the applicable standard;

 

(i)The period of time it is desired that the exemption be in effect, and, if appropriate, the number of units to be manufactured under the exemption;
 

(j)The name, address, and telephone number of the manufacturer or his agent;
 

(k)The name, address, and telephone number of the appropriate office of the U.S. department or agency purchasing the product or class of products;
 

(l)Such other information required by regulation or by the Department, to evaluate and act on the application. Where such information includes nonclinical laboratory studies, the information shall include, with respect to each nonclinical study, either a statement that each study was conducted in compliance with the requirements set forth in 21 C.F.R., part 58, or, if the study was not conducted in compliance, a statement that describes in detail all differences between the practices used in the study and those required in the regulations. When such information includes clinical investigations involving human subjects, the information shall include, with respect to each clinical investigation, a statement that each investigation was conducted in compliance with the requirements set forth in 21 C.F.R., part 56, or a statement that the investigation is not subject to such requirements in accordance with 21 C.F.R. §§ 56.104 or 56.105 and a statement that each investigation was conducted in compliance with the requirements set forth in 21 C.F.R., part 50; and

(m)With respect to each nonclinical laboratory study contained in the application, either a statement that the study was conducted in compliance, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance.

 

10848.7An exemption is granted on the basis of the information contained in the original application. Therefore, if changes are needed in the radiation safety specifications for the product, or its use, or related radiation control procedures such that the information in the original application would no longer be correct with respect to radiation safety, the applicant shall submit in advance of such changes a request for an amendment to the exemption. He or she also shall submit a request for extension of the exemption, if needed, at least sixty (60) days before the expiration date. The application for amendment or extension of an exemption shall include the following information:

 

(a) The exemption number and expiration date; and

 

(b)The amendment or extension requested and basis for the amendment or extension.
 

10848.8If the radiation safety specifications for the product or class of products or the product's or class of products' use or related radiation control procedures differ from the description provided in the original application, a description of such changes.
 

10848.9The Department may grant an exemption including in the written notice of exemption such conditions or terms as may be necessary to protect the public health and safety and shall notify the applicant in writing of his or her action. The conditions or terms of the exemption may include specifications concerning the manufacture, use, control, and disposal of the excess or surplus exempted product of class of products as provided in the Code of Federal Regulations, Title 41, Subtitle C. Each exemption will be assigned an identifying number.

 

10848.10The Department shall amend or withdraw an exemption whenever the Department determines that such action is necessary to protect the public health or otherwise is justified by provisions of the act or this chapter. Such action shall become effective on the date specified in the written notice of the action sent to the applicant, except that it shall become effective immediately when the Director determines that it is necessary to prevent an imminent health hazard.

 

10848.11The manufacturer of any product for which an exemption is granted shall provide the following identification 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 exemption:

       CAUTION

This electronic product has been exempted from Department of Health radiation safety performance standards prescribed in Chapter 108 (Radiological Health), pursuant to Exemption No.______, granted on ________.

 

 

authority

Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, effective September 16, 1980 (D.C. Law 3-98; D.C. Official Code § 47-2885.18(a)(3) (2005 Repl.)); Mayor’s Order 98-48, dated April 15, 1998; Section 4902 of the Fiscal Year 2002 Budget Support Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code § 7-731 (2008 Repl.)); Section 15 of the District of Columbia Medical Device Manufacture and Distribution Licensure Act of 1990, effective June 13, 1990 (D.C. Law 8-137; D.C. Official Code § 48-714(a) (2005 Repl.)); and Mayor’s Order 98-88, dated May 29, 1998.

source

Final Rulemaking published at 60 DCR 10252 (July 12, 2013).