D.C. Mun. Regs. tit. 22, r. 22-B10602

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

Rule 22-B10602 - CONFIDENTIALITY OF DATA AND INFORMATION IN A PREMARKET APPROVAL APPLICATION (PMA) FILE

10602.1

A premarket approval application file (PMA file) includes all data and information submitted with or incorporated by reference in the PMA, any investigational device exemption (IDE) incorporated into the PMA, any PMA supplement, any report under § 10616, any master file, or any other related submission. Any record in the PMA file will be available for public disclosure in accordance with the provisions of this section. The confidentiality of information in a color additive petition submitted as part of a PMA is governed by § 10629.5.

10602.2

The existence of a PMA file may not be disclosed by the Department before an approval order is issued to the applicant unless it was previously publicly disclosed or acknowledged.

10602.3

If the existence of a PMA file has not been publicly disclosed or acknowledged, data or information in the PMA file are not available for public disclosure.

10602.4

If the existence of a PMA file has been publicly disclosed or acknowledged before an order approving, or an order denying approval of the PMA is issued, data or information contained in the file are not available for public disclosure before such order issues. DOH may, however, disclose a summary of portions of the safety and effectiveness data before an approval order or an order denying approval of the PMA issues if disclosure is relevant to public consideration of a specific pending issue.

10602.5

Notwithstanding § 10602.4, the Department will make available to the public upon request the information in the IDE that was required to be filed for investigations involving an exception from informed consent in § 10602.6. Persons wishing to request this information shall submit a request under the Freedom of Information Act of 1976, effective March 25, 1977 (D.C. Law 1-96, D.C. Official Code § 2-531, et seq. (2011 Repl. and 2012 Supp.)).

10602.6

The Institutional Research Board (IRB) responsible for the review, approval, and continuing review of the clinical investigation described in this section may approve that investigation without requiring that informed consent of all research subjects be obtained if the IRB (with the concurrence of a licensed physician who is a member of or consultant to the IRB and who is not otherwise participating in the clinical investigation) finds and documents each of the following:

(a) The human subjects are in a life-threatening situation, available treatments are unproven or unsatisfactory, and the collection of valid scientific evidence, which may include evidence obtained through randomized placebo-controlled investigations, is necessary to determine the safety and effectiveness of particular interventions;

(1) Obtaining informed consent is not feasible because:

(A) The subjects will not be able to give their informed consent as a result of their medical condition;

(B) The intervention under investigation must be administered before consent from the subjects' legally authorized representatives is feasible; and

(C) There is no reasonable way to identify prospectively the individuals likely to become eligible for participation in the clinical investigation;

(2) Participation in the research holds out the prospect of direct benefit to the subjects because:

(A) Subjects are facing a life-threatening situation that necessitates intervention;

(B) Appropriate animal and other preclinical studies have been conducted, and the information derived from those studies and related evidence support the potential for the intervention to provide a direct benefit to the individual subjects;

(C) Risks associated with the investigation are reasonable in relation to what is known about the medical condition of the potential class of subjects, the risks and benefits of standard therapy, if any, and what is known about the risks and benefits of the proposed intervention or activity;

(D) The clinical investigation could not practicably be carried out without the waiver;

(E) The proposed investigational plan defines the length of the potential therapeutic window based on scientific evidence, and the investigator has committed to attempting to contact a legally authorized representative for each subject within that window of time and, if feasible, to asking the legally authorized representative contacted for consent within that window rather than proceeding without consent. The investigator will summarize efforts made to contact legally authorized representatives and make this information available to the IRB at the time of continuing review; and

(F) The IRB has reviewed and approved informed consent procedures and an informed consent document consistent with 21 C.F.R § 50.25. These procedures and the informed consent document are to be used with subjects or their legally authorized representatives in situations where use of such procedures and documents is feasible. The IRB has reviewed and approved procedures and information to be used when providing an opportunity for a family member to object to a subject's participation in the clinical investigation consistent with Paragraph (3)(E) of this subsection; and

(3) Additional protections of the rights and welfare of the subjects will be provided, including, at least:

(A) Consultation (including, where appropriate, consultation carried out by the IRB) with representatives of the communities in which the clinical investigation will be conducted and from which the subjects will be drawn;

(B) Public disclosure to the communities in which the clinical investigation will be conducted and from which the subjects will be drawn, prior to initiation of the clinical investigation, of plans for the investigation and its risks and expected benefits;

(C) Public disclosure of sufficient information following completion of the clinical investigation to apprise the community and researchers of the study, including the demographic characteristics of the research population, and its results;

(D) Establishment of an independent data monitoring committee to exercise oversight of the clinical investigation; and

(E) If obtaining informed consent is not feasible and a legally authorized representative is not reasonably available, the investigator has committed, if feasible, to attempting to contact within the therapeutic window the subject's family member who is not a legally authorized representative, and asking whether he or she objects to the subject's participation in the clinical investigation. The investigator will summarize efforts made to contact family members and make this information available to the IRB at the time of continuing review.

10602.7

The IRB is responsible for ensuring that procedures are in place to inform, at the earliest feasible opportunity, each subject, or if the subject remains incapacitated, a legally authorized representative of the subject, or if such a representative is not reasonably available, a family member, of the subject's inclusion in the clinical investigation, the details of the investigation and other information contained in the informed consent document. The IRB shall also ensure that there is a procedure to inform the subject, or if the subject remains incapacitated, a legally authorized representative of the subject, or if such a representative is not reasonably available, a family member, that he or she may discontinue the subject's participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. If a legally authorized representative or family member is told about the clinical investigation and the subject's condition improves, the subject is also to be informed as soon as feasible. If a subject is entered into a clinical investigation with waived consent and the subject dies before a legally authorized representative or family member can be contacted, information about the clinical investigation is to be provided to the subject's legally authorized representative or family member, if feasible.

10602.8

The IRB determinations required by § 10602.6 and the documentation required by § 10602.10 are to be retained by the IRB for at least three (3) years after completion of the clinical investigation, and the records shall be accessible for inspection and copying by the Department.

10602.9

Protocols involving an exception to the informed consent requirement under this section must be performed under a separate IND application or IDE that clearly identifies such protocols as protocols that may include subjects who are unable to consent. The submission of those protocols in a separate IND or IDE is required even if an IND for the same drug product or an IDE for the same device already exists. Applications for investigations under this section may not be submitted as amendments.

10602.10

If an IRB determines that it cannot approve a clinical investigation because the investigation does not meet the criteria in the exception provided under § 10602.6 or because of other relevant ethical concerns, the IRB shall document its findings and provide these findings promptly in writing to the clinical investigator and to the sponsor of the clinical investigation. The sponsor of the clinical investigation must promptly disclose this information to the Department and to the sponsor's clinical investigators who are participating or are asked to participate in this or a substantially equivalent clinical investigation of the sponsor, and to other IRBs that have been, or are, asked to review this or a substantially equivalent investigation by that sponsor.

10602.11

Upon issuance of an order approving, or an order denying approval of any PMA, the Department will make available to the public the fact of the existence of the PMA and a detailed summary of information submitted to the Department respecting the safety and effectiveness of the device that is the subject of the PMA and that is the basis for the order.

10602.12

After the Department issues an order approving, or an order denying approval of any PMA, the following data and information in the PMA file are immediately made available for public disclosure:

(a) All safety and effectiveness data and information previously disclosed to the public, as such disclosure is defined in 21 C.F.R. § 20.81;

(b) Any protocol for a test or study unless the protocol is shown to constitute trade secret or confidential commercial or financial information under 21 C.F.R. § 20.61;

(c) Any adverse reaction report, product experience report, consumer complaint, and other similar data and information, after deletion of:

(1) Any information that constitutes trade secret or confidential commercial or financial information under 21 C.F.R. § 20.61; and

(2) Any personnel, medical, and similar information disclosure of which would constitute a clearly unwarranted invasion of personal privacy under 21 C.F.R. § 20.63; provided, however, that except for the information that constitutes trade secret or confidential commercial or financial information under 21 C.F.R. § 20.61, DOH will disclose to a patient who requests a report all the information in the report concerning that patient;

(d) A list of components previously disclosed to the public, as defined in 21 C.F.R. § 20.81;

(e) An assay method or other analytical method, unless it does not serve any regulatory purpose and is shown to fall within the exemption in 21 C.F.R. § 20.61 for trade secrets or confidential commercial or financial information; and

(f) All correspondence and written summaries of oral discussions relating to the PMA file.

10602.13

All safety and effectiveness data and other information not previously disclosed to the public are available for public disclosure if any one of the following events occurs and the data and information do not constitute trade secret or confidential commercial or financial information under 21 C.F.R. § 20.61:

(a) The PMA has been abandoned. The Department will consider a PMA abandoned if:

(1) The applicant fails to respond to a request for additional information within one hundred eighty (180) days after the date the Department issues the request; or

(2) Other circumstances indicate that further work is not being undertaken with respect to it, and

(3) The applicant fails to communicate with the Department within seven (7) days after the date on which the Department notifies the applicant that the PMA appears to have been abandoned.

(b) An order denying approval of the PMA was issued and all legal appeals have been exhausted;

(c) An order withdrawing approval of the PMA has issued, and all legal appeals have been exhausted;

(d) The device has been reclassified;

(e) The device has been found to be substantially equivalent to a class I or class II device; or

(f) The PMA is considered voluntarily withdrawn under § 10611 of this chapter.

10602.14

The following data and information in a PMA file are not available for public disclosure unless they have been previously disclosed to the public, or they relate to a device for which a PMA has been abandoned and they no longer represent a trade secret or confidential commercial or financial information as defined in 21 C.F.R. § 20.61:

(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 are not available for public disclosure under this provision is available for public disclosure; or

(c) Quantitative or semi-quantitative formulas.

10602.15

The procedure for trade secrets and commercial or financial information which is privileged or confidential shall be as follows:

(a) A trade secret may consist of any commercially valuable plan, formula, process, or device that is used for the making, preparing, compounding, or processing of trade commodities and that can be said to be the end product of either innovation or substantial effort. There must be a direct relationship between the trade secret and the productive process;

(b) Commercial or financial information that is privileged or confidential means valuable data or information which is used in one's business and is of a type customarily held in strict confidence or regarded as privileged and not disclosed to any member of the public by the person to whom it belongs;

(c) Data and information submitted or divulged to the Department which falls within the definitions of a trade secret or confidential commercial or financial information are not available for public disclosure;

(d) A person who submits records to the Department may designate part or all of the information in such records as exempt from disclosure under exemption 4 of the Freedom of Information Act. The person may make this designation either at the time the records are submitted to the government or within a reasonable time thereafter. The designation must be in writing. Where a legend is required by a request for proposals or request for quotations, pursuant to 48 C.F.R. § 352.215-12, then that legend is necessary for this purpose. Any such designation will expire ten (10) years after the records are submitted to the Department;

(e) The procedures in this paragraph apply to records on which the submitter has designated information as provided in Paragraph (d) of this subsection. These procedures also apply to records that were submitted to the Department when the agency has substantial reason to believe that information in the records could reasonably be considered exempt under exemption 4 of the Freedom of Information Act. Certain exceptions to these procedures are set forth in Paragraph (f) of this subsection. In addition:

(1) When the Department receives a request for such records and determines that disclosure may be required, the Department will make reasonable efforts to notify the submitter about these facts. The notice will include a copy of the request, and it will inform the submitter about the procedures and time limits for submission and consideration of objections to disclosure. If the Department must notify a large number of submitters, notification may be done by posting or publishing a notice in a place where the submitters are reasonably likely to become aware of it;

(2) The submitter has five (5) working days from receipt of the notice to object to disclosure of any part of the records and to state all bases for its objections;

(3) The Department will give consideration to all bases that have been stated in a timely manner by the submitter. If the Department decides to disclose the records, the Department will notify the submitter in writing. This notice will briefly explain why the agency did not sustain the submitter's objections. The Department will include with the notice a copy of the records about which the submitter objected, as the agency proposes to disclose them. The notice will state that the Department intends to disclose the records five (5) working days after the submitter receives the notice unless a court orders the agency not to release them;

(4) If a requester files suit under the Freedom of Information Act to obtain records covered by this paragraph, the Department will promptly notify the submitter; and

(5) Whenever the Department sends a notice to a submitter under Paragraph (e)(1) of this subsection, the Department will notify the requester that the Department is giving the submitter a notice and an opportunity to object. Whenever the DOH sends a notice to a submitter under Paragraph (e)(3) of this subsection, the Department will notify the requester of this fact; and

(f) The notice requirements in Paragraph (e) of this subsection shall not apply in the following situations:

(1) The Department decided not to disclose the records;

(2) The information was published previously or made generally available;

(3) Disclosure is required by a regulation issued after notice and opportunity for public comment that specifies narrow categories of records that are to be disclosed under the Freedom of Information Act. In this case, however, a submitter may still designate records as described in Paragraph (d) of this subsection, and in exceptional cases, the Department may, at its discretion, follow the notice procedures in Paragraph (e) of this subsection;

(4) The submitter did not designate the information requested as exempt from disclosure when the submitter had an opportunity to do so at the time of submission of the information or within a reasonable time thereafter, unless the Department has substantial reason to believe that disclosure of the information would result in competitive harm; or

(5) The designation appears to be frivolous, but in this case the Department will still give the submitter the written notice required by Subsection (e)(3) (although this notice need not explain the Department's decision or include a copy of the records), and the Department will notify the requester as described in Subsection (e)(5).

D.C. Mun. Regs. tit. 22, r. 22-B10602

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.