D.C. Mun. Regs. tit. 22, r. 22-B10847
Current through Register Vol. 71, No. 49, December 6, 2024
Rule 22-B10847 - VARIANCES10847.1Upon application by a manufacturer (including an assembler), the Department may grant a variance from one (1) or more provisions of any performance standard 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 act, and:
(a) The scope of the requested variance is so limited in its applicability as not to justify an amendment to the standard; or(b) There is not sufficient time for the promulgation of an amendment to the standard.10847.2The issuance of the variance shall be based upon a determination that:
(a) 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;(b) 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(c) One (1) or more requirements of the applicable standard are not appropriate, and suitable means for assuring radiation safety or protection are provided.10847.3If you are submitting an application for variances or for amendments or extensions thereof, you must submit an original and two (2) copies to the Department.
10847.4The application for variance shall include the following information:
(a) A description of the product and its intended use;(b) An explanation of how compliance with the applicable standard would restrict or be inappropriate for this intended use;(c) A description of the manner in which it is proposed to deviate from the requirements of the applicable standard;(d) A description of the advantages to be derived from such deviation;(e) An explanation of how alternate or suitable means of radiation protection will be provided;(f) 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;(g) In the case of prototype or experimental equipment, the proposed location of each unit;(h) Such other information required by regulation or by the Department, to evaluate and act on the application;(i) 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 or, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance; and(j) If the electronic product is used in a clinical investigation involving human subjects, is subject to the requirements for institutional review set forth in 21 C.F.R., part 56, and is subject to the requirements for informed consent set forth in 12 C.F.R., part 50, the investigation shall be conducted in compliance with such requirements.10847.5The application for amendment or extension of a variance shall include the following information:
(a) The variance number and expiration date;(b) The amendment or extension requested and basis for the amendment or extension;(c) A description of the effect of the amendment or extension on protection from radiation produced by the product; and(d) An explanation of how alternate or suitable means of protection will be provided.10847.6The Department 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, 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.
10847.7The Department shall amend or withdraw a variance whenever the Department determines that this action is necessary to protect the public health or otherwise is justified by this chapter. 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 to the applicant when the Department determines that such action is necessary to prevent an imminent health hazard.
10847.8All applications for variances and for amendments and extensions thereof and all correspondence (including written notices of approval) on these applications will be available to the public except for information regarded as confidential under Section 537 of the Act.
10847.9The manufacturer of any product for which a variance is granted shall modify the tag, label, or other certification required by § 10845 to state:
(a) That the product is in conformity with the applicable standard, except with respect to those characteristics covered by the variance;(b) That the product is in conformity with the provisions of the variance; and(c) The assigned number and effective date of the variance.D.C. Mun. Regs. tit. 22, r. 22-B10847
Final Rulemaking published at 60 DCR 10252 (July 12, 2013)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.