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Certificates of Confidentiality; Draft Guidance for Sponsors,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the availability of a draft guidance entitled ``Certificates of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draft guidance is intended to explain FDA implementation of the revised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DATES: Submit either electronic or written comments on the draft
guidance by January 9, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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proposed information collection burden in the draft guidance by January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