Section 22-B10629. CONFIDENTIALITY OF DATA AND INFORMATION

 

10629.1The "HDE file" includes all data and information submitted with or referenced in the HDE, any IDE incorporated into the HDE, any HDE amendment or supplement, any report submitted under § 10631, any master file, or any other related submission. Any record in the HDE file will be available for public disclosure in accordance with the provisions of this section.

 

10629.2Disclosure by the Department of the existence and contents of an HDE file shall be subject to the same rules that pertain to PMA's under § 10602.2 through 10602.10, as applicable. 

 

10629.3The HDE holder is responsible for ensuring that a HUD approved under this section is administered only in facilities having an IRB constituted and acting pursuant to § 10631, including continuing review of use of the device. In addition, a HUD may be administered only if the IRB approves such use located at the facility or by a similarly constituted IRB that has agreed to oversee such use and to which the local IRB has deferred in a letter to the HDE holder, signed by the IRB chair or an authorized designee. If, however, a physician in an emergency situation determines that approval from an IRB cannot be obtained in time to prevent serious harm or death to a patient, a HUD may be administered without prior approval by the IRB located at the facility or by a similarly constituted IRB that has agreed to oversee such use. In such an emergency situation, the physician shall, within five (5) days after the use of the device, provide written notification to the chairman of the IRB of such use. Such written notification shall include the identification of the patient involved, the date on which the device was used, and the reason for the use.

 

10629.4A holder of an approved HDE shall notify the Department of any withdrawal of approval for the use of a HUD by a reviewing IRB within five (5) working days after being notified of the withdrawal of approval.

 

10629.5In regards to the confidentiality of data and information in color additive petitions: the following data and information in a color additive petition are available for public disclosure, unless extraordinary circumstances are shown, after the notice of filing of the petition is published or, if the petition is not promptly filed because of deficiencies in it, after the petitioner is informed that it will not be filed because of the deficiencies involved:

 

(a)All safety and functionality data and information submitted with or incorporated by reference in the petition;

 

(b)A protocol for a test or study, unless it is shown to fall within the exemption established for trade secrets and confidential commercial information;

 

(c)Adverse reaction reports, product experience reports, consumer complaints, and other similar data and information, after deletion of:

 

(1)Names and any information that would identify the person using the product;

(2)Names and any information that would identify any third party involved with the report, such as a physician, hospital, or other institution;

 

(3)A list of all ingredients contained in a color additive, whether or not it is in descending order of predominance. A particular ingredient or group of ingredients shall be deleted from any such list prior to public disclosure if it is shown to fall within an exemption and a notation shall be made that any such ingredient list is incomplete;

 

(4)An assay method or other analytical method, unless it serves no regulatory or compliance purpose and is shown to fall within an exemption; and

 

(5)All records showing the Department's testing of or action on a particular lot of a certifiable color additive.

 

10629.6The following data and information in a color additive petition are not available for public disclosure unless they have been previously disclosed to the public or they relate to a product or ingredient that has been abandoned and they no longer represent a trade secret or confidential commercial or financial information:

 

(a)Manufacturing methods or processes, including quality control procedures;

(b)Production, sales, distribution, and similar data and information, except that any compilation of such data and information aggregated and prepared in a way that does not reveal data or information which is not available for public disclosure under this provision is available for public disclosure; and

 

(c)Quantitative or semi-quantitative formulas.

 

10629.7All correspondence and written summaries of oral discussions relating to a color additive petition are available for public disclosure when the color additive regulation is published by the Department.

 

10629.8For purposes of this regulation, safety and functionality data include all studies and tests of a color additive on animals and humans and all studies and tests on a color additive for identity, stability, purity, potency, performance, and usefulness.

 

 

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).