Document ID: FDA-2019-D-3592-0009
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Certificates of
Confidentiality
Posted Date: 2020-06-17T04:00Z

[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]]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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, 
PRAStaff@fda.hhs.gov.

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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submissions of CoC Requests From Sponsors, Sponsor-Investigators,               150                1              150                2              300
 or Authorized Representatives.....................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

[[Page 36603]]

    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]
BILLING CODE 4164-01-P