[Federal Register Volume 85, Number 221 (Monday, November 16, 2020)]
[Notices]
[Pages 73056-73057]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25238]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-3592]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance entitled ``Certificates of 
Confidentiality; Guidance for Sponsors, Sponsor-Investigators, 
Researchers, Industry, and Food and Drug Administration Staff.'' This 
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. This guidance finalizes the draft guidance 
of the same title issued on November 25, 2019.

DATES: The announcement of the guidance is published in the Federal 
Register on November 16, 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, 240-
402-7500.
     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.govinfo.gov/content/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, 240-402-7500.
    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 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 final 
guidance document.

FOR FURTHER INFORMATION CONTACT: Jarilyn Dupont, Office of Policy, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4248, 
Silver Spring, MD 20993-0002, 301-796-4716.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance to explain 
FDA's 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,

[[Page 73057]]

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 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 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 
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 guidance finalizes the draft guidance entitled ``Certificates 
of Confidentiality; Guidance for Sponsors, Sponsor-Investigators, 
Researchers, Industry, and Food and Drug Administration Staff'' issued 
on November 25, 2019 (84 FR 64906). FDA considered comments received on 
the draft guidance as the guidance was finalized. Changes from the 
draft to the final guidance were made to address requests for 
definitional and process clarity.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The 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

    While this guidance contains no collection of information, it does 
refer to a previously approved FDA collection of information. 
Therefore, clearance by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required. The previously approved collections of information are 
subject to review by OMB under the PRA. The collections of information 
have been approved under OMB control number 0910-0130.

III. Electronic Access

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

    Dated: November 9, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-25238 Filed 11-13-20; 8:45 am]
BILLING CODE 4164-01-P


