D.C. Mun. Regs. tit. 22, r. 22-B10829

Current through Register Vol. 71, No. 49, December 6, 2024

Rule 22-B10829 - GRANTING THE EXEMPTION

10829.1

If, in the judgment of the Department, the application filed pursuant to § 10828 states reasonable grounds for an exemption from the requirement of notice, the Department shall give the manufacturer written notice specifying a reasonable period of time during which he or she may present his or her views and evidence in support of the application.

10829.2

Such views and evidence shall be confined to matters relevant to whether the defect in the product or its failure to comply with an applicable District standard is such as to create a significant risk of injury, including genetic injury, to any person and shall be presented in writing unless the Department determines that an oral presentation is desirable. Where such evidence includes nonclinical laboratory studies, the data submitted shall include, with respect to each such study, either a statement that the 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 with such regulations, a brief statement of the reason for the noncompliance. When such evidence includes clinical investigations involving human subjects, the data submitted shall include, with respect to each clinical investigation either 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 21 C.F.R. § 56.105, and a statement that each investigation was conducted in compliance with the requirements set forth in 21 C.F.R., part 50.

10829.3

If, during the period of time afforded the manufacturer to present his views and evidence, the manufacturer proves to the Department's satisfaction that the defect or failure to comply does not create a significant risk of injury, including genetic injury, to any person, the Department shall issue an exemption from the requirement of notification to the manufacturer and shall notify the manufacturer in writing specifying:

(a) The electronic product or products for which the exemption has been issued; and

(b) Such conditions as the Department deems necessary to protect the public health and safety.

10829.4

Any person who contests denial of an exemption shall have an opportunity for a regulatory hearing before the Department.

D.C. Mun. Regs. tit. 22, r. 22-B10829

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.