[Federal Register Volume 84, Number 227 (Monday, November 25, 2019)]
[Notices]
[Pages 64906-64909]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25551]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Certificates of Confidentiality; Draft Guidance for Sponsors, 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.

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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the availability of a draft guidance entitled ``Certificates of 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draft guidance is intended to explain FDA implementation of the revised 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DATES: Submit either electronic or written comments on the draft 
guidance by January 9, 2020 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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proposed information collection burden in the draft guidance by January 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:

[[Page 64907]]

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, [email protected].

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

[[Page 64908]]

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).\1\
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    \1\ Investigational New Drug Application/New Drug Application/
Biologics License Application/Investigational Device Exemption/
Humanitarian Device Exemption/Premarket Application/Premarket 
Tobacco Product Application/Investigational Tobacco Product.
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     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:
    [cir] Necessary for the medical treatment of the individual to whom 
the information, document, or biospecimen pertains and made with the 
consent of such individual;
    [cir] Made with the consent of the individual to whom the 
information, document, or biospecimen pertains; or
    [cir] 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

[[Page 64909]]

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:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
  Draft guidance for sponsors, sponsor-investigators, researchers,      Number of      responses per     Total annual   Average  burden    Total hours
                  industry, and FDA staff on CoCs                      respondents       respondent       responses      per  response
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Submissions of CoC Requests From Sponsors, Sponsor-Investigators,               150                1              150                2              300
 or Authorized Representatives.....................................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

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.

    Dated: November 20, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25551 Filed 11-22-19; 8:45 am]
BILLING CODE 4164-01-P