Certificates of Confidentiality; Draft Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of availability.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled “Certificates of Confidentiality; Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff.” This draft guidance is intended to explain FDA implementation of the revised statutory provisions applicable to the request for, and issuance of, a Certificate of Confidentiality (CoC). The 21st Century Cures Act (Cures Act) amended the statutory provisions relating to the issuance of CoCs. A CoC is intended to help protect the privacy of human subject research participants from whom sensitive and identifiable information is being collected or used in furtherance of the research. Historically, a CoC generally protected a researcher from being compelled in a legal proceeding to disclose identifiable sensitive information about the research participant, created or compiled for the research. As amended, a CoC prohibits a researcher from disclosing such information unless a specified exception applies.

DATES:

Submit either electronic or written comments on the draft guidance by January 9, 2020 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. Submit electronic or written comments on the proposed information collection burden in the draft guidance by January 24, 2020.

ADDRESSES:

You may submit either electronic or written comments on any guidance at any time as follows:

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: https://www.regulations.gov . Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov .
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

• Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2019-D-3592 for “Certificates of Confidentiality; Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov . Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf .

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

Submit written requests for single copies of this draft guidance to the Office of Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4248, Silver Spring, MD 20993-0002. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:

With regard to the draft guidance: Jarilyn Dupont, Office of Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4248, Silver Spring, MD 20993-0002, 301-796-4850.

With regard to the proposed collection of information: Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance to explain FDA's proposed implementation of the revised provisions applicable to the request for, and issuance of, a discretionary CoC. The Cures Act (Pub. L. 114-255, section 2012) amended the Public Health Service Act, section 301(d) (42 U.S.C. 241(d)), relating to the issuance of CoCs. A CoC is intended to help protect the privacy of human subject research participants from whom identifiable, sensitive information is being collected or used in furtherance of the research. Historically, a CoC generally protected a researcher from being compelled in a legal proceeding (such as by subpoena or court order) to disclose identifiable and sensitive information about the research participant, created or compiled for purposes of the human subject research. The Cures Act broadened the protections of the statutory provision by affirmatively prohibiting holders of CoCs from disclosing such information unless a specific exception applies.

The Cures Act simplified certain aspects of the issuance of CoCs by requiring that CoCs be issued for federally funded human subject research that collects or uses identifiable, sensitive information (referred to in the draft guidance as mandatory CoCs). For non-federally funded research, issuance of CoCs is not required but may be issued at the discretion of FDA (referred to in the draft guidance as discretionary CoCs) when the study involves a product subject to FDA's jurisdiction and regulatory authority. FDA intends to continue receiving such requests and will issue discretionary CoCs as appropriate. This draft guidance is intended to provide information on how to request a discretionary CoC, the statutory requirements for requesting such a CoC, and the statutory responsibilities associated with possessing a CoC. Although the mandatory CoC and the discretionary CoC are issued under different processes, the protections afforded by the issuance of either CoC are identical and the statutory responsibilities are applicable to both.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance represents the current thinking of FDA on “Certificates of Confidentiality; Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Protection of Human Subjects

OMB Control Number 0910-0755—Revision

CoCs are intended to help protect the privacy of human subject research participants from whom identifiable, sensitive information is being collected in furtherance of the research. A CoC generally protects a researcher from being compelled to disclose identifiable sensitive information about the research participant, created or compiled for purposes of the human subject research. The holder of the CoC may not disclose such information unless a specified exception applies. For non-federally funded research, issuance of CoCs is not required but may be issued at the discretion of FDA (discretionary CoCs) when the study involves a product subject to FDA's jurisdiction and regulatory authority. The draft guidance is intended to provide information on how to request a discretionary CoC, the statutory requirements for requesting such a CoC, and the statutory responsibilities associated with possessing a CoC. We already receive such CoC requests and will issue discretionary CoCs as appropriate. As discussed in the draft guidance, to help ensure that discretionary CoCs are issued to those entities who can comply with the requirements of the statutory provision, we recommend that only sponsors or sponsor-investigators submit requests for discretionary CoCs (as defined in 21 CFR 50.3, 312.3, and 812.3) (i.e., the individual who takes responsibility for or initiates the clinical investigation). This will help eliminate duplicative requests to FDA for the same human subject research. Accordingly, we are revising the information collection approved under OMB control number 0910-0755 (Protection of Human Subjects) to include the additional information collection elements recommended in the draft guidance.

A. Descriptive Information

To facilitate our review and expedite consideration of a discretionary CoC request, sponsors, sponsor-investigators, or the authorized representative should include descriptive information in their submission. The information is listed below and in “Section IV. Request for Discretionary CoCs From FDA” of the draft guidance.

• Sponsor or Sponsor-Investigator Name or authorized representative (e.g., the individual who takes responsibility for or initiates the clinical investigation).
• Sponsor or Sponsor-Investigator or authorized representative Address (same as on file with FDA).
• Sponsor or Sponsor-Investigator or authorized representative email address.
• FDA Application Number, as available (e.g., IND/NDA/BLA/IDE/HDE/PMA/PMTA/ITP).

• ClinicalTrials.gov numerical identifier (if applicable) (number provided upon registration on www.ClinicalTrials.gov ).
• Title of research.
• If conducting human subject research that is subject to FDA's jurisdiction but the sponsor or sponsor-investigator is exempt from submitting an application (e.g., IND/IDE), submit all of the above information, with the exception of the FDA application number.
• Signature of Sponsor, Sponsor-Investigator, or authorized representative who submits the CoC request.

B. Assurances

Sponsors, sponsor-investigators, and authorized representatives who receive a CoC must also comply with the statutory provisions for CoCs to protect the confidentiality of identifiable, sensitive information that is collected or used for purposes of the research. Such requestors of a CoC should include the following assurances in their submission as described in detail in “Section IV. Request for Discretionary CoCs From FDA” of the draft guidance.

• The requestor is engaged in biomedical, behavioral, clinical, or other research, in which identifiable, sensitive information is collected or used.
• The research involves a product subject to FDA's jurisdiction and regulatory authority.
• The requestor will be responsible for complying with the requirements to protect the confidentiality of identifiable, sensitive information collected or used in biomedical, behavioral, clinical, or other research.
• The requestor will not disclose in any legal proceeding or to any other individual unless the requestor has the individual's consent or provide the name of an individual or any such information, document, or biospecimen that contains identifiable, sensitive information about the individual and that was created or compiled for purposes of the research.

The requestor understands and agrees that disclosure is permitted by the recipient of a CoC only when required by Federal, State, or local laws, or it is:

○ Necessary for the medical treatment of the individual to whom the information, document, or biospecimen pertains and made with the consent of such individual;

○ Made with the consent of the individual to whom the information, document, or biospecimen pertains; or

○ Made for the purposes of other scientific research that complies with applicable Federal regulations governing the protection of human subjects in research.

• The requestor understands that the identifiable sensitive information collected by a researcher to whom a certificate is issued and all copies thereof, shall be subject to the protections afforded by this section for perpetuity.

Based on the number of CoC requests we have received prior to the Cures Act, we estimate receiving approximately 150 discretionary CoC requests annually. We estimate that approximately 150 sponsors, sponsor-investigators, or authorized representatives will submit requests. Preparing and sending each request would take approximately 2 hours.

FDA estimates the burden of this collection of information as follows:

III. Electronic Access

Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/RegulatoryInformation/Guidances/default.htm or https://www.regulations.gov .