[Federal Register Volume 85, Number 117 (Wednesday, June 17, 2020)]
[Notices]
[Pages 36602-36603]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13081]
[[Page 36602]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-3592]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Certificates of
Confidentiality
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by July 17, 2020.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to
www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. All comments should be
identified with the OMB control number 0910-0130. Also include the FDA
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: 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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Protection of Human Subjects and Institutional Review Boards;
Certificates of Confidentiality
OMB Control Number 0910-0130--Revision
This information collection supports Agency guidance regarding the
issuance of Certificates of Confidentiality (CoCs). The 21st Century
Cures Act (Cures Act) (Pub. L. 114-255, section 2012) amended the
Public Health Service Act, section 301(d) (42 U.S.C. 241(d)), 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. For efficiency of Agency operations, we are revising
information collection currently approved under OMB Control No. 0910-
0130 pertaining to the protection of human subjects and institutional
review boards to include information collection pertaining to the
issuance of CoCs. As information collection activity is planned and
undertaken by FDA, we find consolidating related collection elements
better utilizes our resources. We have developed guidance to assist
respondents to the information collection with this topic and are
including it in the information collection accordingly.
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.
To assist respondents with information collection attendant to
CoCs, we developed the draft guidance document entitled ``Certificates
of Confidentiality; Draft Guidance for Sponsors, Sponsor-Investigators,
Researchers, Industry, and Food and Drug Administration Staff.'' 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. 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. The draft guidance was developed and issued
consistent with our Good Guidance Practice regulations at 21 CFR 10.115
which provide for comment at any time. The draft guidance is available
at: https://www.fda.gov/media/132966/download. We intend to finalize
the draft guidance and are revising the associated information
collection accordingly.
In the Federal Register of November 25, 2019 (84 FR 64906), we
published a notice announcing the availability of the draft guidance
entitled ``Certificates of Confidentiality; Draft Guidance for
Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and
Drug Administration Staff; Availability,'' including an analysis of
burden that may be attributable to the information collection
recommendations. Although we received some comments requesting that
clarifying discussion be included with regard to topics covered in the
guidance, no comments were received in response to the four information
collection topics solicited under the PRA.
We estimate 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.
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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
Dated: June 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-13081 Filed 6-16-20; 8:45 am]
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