Certificates of Confidentiality; Draft Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff; Availability, 64906-64909 [2019-25551]
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Federal Register / Vol. 84, No. 227 / Monday, November 25, 2019 / Notices
Dated: November 4, 2019.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
needs and request grant awards under
the TANF program. In addition, the
form is used to report data in
substantiation of state claims and to
certify the availability of the
legislatively mandated state match. ACF
will use the financial data provided by
states to estimate quarterly funding
needs, calculate award amounts, and
assess compliance with statutory and
regulatory requirements relating to
administrative costs and state matching
requirements. No changes are proposed
to the form.
[FR Doc. 2019–25430 Filed 11–22–19; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Form ACF–196, TANF
Financial Reporting Form for States
Comments due within 60 days of
publication. In compliance with the
requirements of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
the Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
DATES:
Office of Family Assistance;
Administration for Children and
Families; HHS.
ACTION: Request for public comment.
AGENCY:
The Administration for
Children and Families (ACF) is
requesting to renew approval of the
ACF–196 Temporary Assistance for
Needy Families (TANF) Financial
Reporting Form. The ACF–196 is the
form used by states to estimate funding
SUMMARY:
Copies of the proposed
collection of information can be
obtained and comments may be
forwarded by emailing infocollection@
acf.hhs.gov. Alternatively, copies can
also be obtained by writing to the
ADDRESSES:
Administration for Children and
Families, Office of Planning, Research,
and Evaluation (OPRE), 330 C Street
SW, Washington, DC 20201, Attn: ACF
Reports Clearance Officer. All requests,
emailed or written, should be identified
by the title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: This information
collection is authorized under Section
411(a)(3) of the Social Security Act. This
request is for renewal of approval to the
ACF–196 form for periodic financial
reporting under the TANF program.
States participating in the TANF
program are required by statute to report
financial data on a quarterly basis. This
form meets the legal standard and
provides essential data on the use of
federal funds. Failure to collect the data
would seriously compromise ACF’s
ability to monitor program
expenditures, estimate funding needs,
and to prepare budget submissions
required by Congress. Financial
reporting under the TANF program is
governed by 45 CFR part 265.
Respondents: TANF Agencies.
ANNUAL BURDEN ESTIMATES
Instrument
Total
number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Annual
burden hours
ACF–196 ..........................................................................................................
51
4
10
2,040
Estimated Total Annual Burden
Hours: 2,040.
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: U.S.C. Section 402 of the Social
Security Act (42 U.S.C. 602).
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019–25432 Filed 11–22–19; 8:45 am]
BILLING CODE 4184–36–P
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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, SponsorInvestigators, Researchers, Industry,
and Food and Drug Administration
Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
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
SUMMARY:
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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.
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.
DATES:
You may submit either
electronic or written comments on any
guidance at any time as follows:
ADDRESSES:
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Federal Register / Vol. 84, No. 227 / Monday, November 25, 2019 / Notices
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
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17:31 Nov 22, 2019
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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/201523389.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, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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64907
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
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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)
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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
• 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 sponsor1 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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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, SponsorInvestigator, 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:
Æ Necessary for the medical treatment
of the individual to whom the
information, document, or biospecimen
pertains and made with the consent of
such individual;
Æ Made with the consent of the
individual to whom the information,
document, or biospecimen pertains; or
Æ 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
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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, sponsorinvestigators, or authorized
representatives will submit requests.
64909
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
Draft guidance for sponsors, sponsor-investigators,
researchers, industry, and FDA staff on CoCs
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Submissions of CoC Requests From Sponsors, SponsorInvestigators, or Authorized Representatives ..................
150
1
150
2
300
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/Regulatory
Information/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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Biodefense Science Board:
Public Meeting
Office of the Assistant
Secretary for Preparedness and
Response (ASPR), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
The HHS Office of the
Secretary is hosting the National
Biodefense Science Board (NBSB)
Public Meeting in Washington, DC,
December 3, 2019. The purpose of the
meeting is to gather information to
develop expert advice provided by
NBSB and guidance to the Secretary on
scientific, technical, and other matters
of special interest to HHS regarding
current and future chemical, biological,
nuclear, and radiological agents,
whether naturally occurring, accidental,
or deliberate. Retiring NBSB board
members will also be presented with
certificates and a signed letter of
appreciation.
DATES: The NBSB Public Meeting is
being held December 3, 2019, from
10:30 a.m. to 4:30 p.m. Eastern Daylight
Time (EDT).
ADDRESSES: Please visit the NBSB
website (https://www.phe.gov/nbsb) for
all additional information regarding the
NBSB or meeting details.
FOR FURTHER INFORMATION CONTACT:
CAPT Christopher Perdue, MD, MPH,
SUMMARY:
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Designated Federal Official, NBSB,
ASPR, HHS; 202–401–5837;
christopher.perdue@hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to section 319M of the Public Health
Service Act, HHS has established the
NBSB to provide expert advice and
guidance to the Secretary on scientific,
technical, and other matters of special
interest to HHS regarding current and
future chemical, biological, nuclear, and
radiological agents, whether naturally
occurring, accidental, or deliberate.
Availability of Materials: Participants
are encouraged to visit the NBSB
website (https://www.phe.gov/nbsb) for
information about the meeting,
including the agenda.
Procedures for Providing Public Input:
Members of the public are encouraged
to go to the NBSB website (https://
www.phe.gov/nbsb) for instructions
about the submission of written
comments.
Dated: November 20, 2019.
Robert P. Kadlec,
Assistant Secretary for Preparedness and
Response.
[FR Doc. 2019–25544 Filed 11–22–19; 8:45 am]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director, National
Institutes of Health Amended Notice of
Meeting
Notice is hereby given of a change in
the meeting of the Advisory Committee
to the Director, National Institutes of
Health, December 12, 2019, 9:00 a.m. to
December 13, 2019, 1:00 p.m., NIH,
Building 1, Wilson Hall, 1 Center Drive,
Bethesda, MD 20892 which was
published in the Federal Register on
May 2, 2019, 84 FR 18853.
The meeting notice is amended to add
an additional agenda topic entitled, NIH
Wide Strategic Plan for Fiscal Years
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2021–2025. The meeting is open to the
public.
Dated: November 19, 2019.
Natasha M. Copeland,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–25478 Filed 11–22–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Library of Medicine Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable materials,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Library of
Medicine Special Emphasis Panel; COI/
Career Award.
Date: March 19, 2020.
Time: 11:00 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Library of Medicine/Center
for Scientific Review, 6701 Rockledge Drive,
Bethesda, MD 20892, (Virtual Meeting).
Contact Person: Yanli Wang, Ph.D.,
Scientific Review Officer, Division of
Extramural Programs, National Library of
Medicine, NIH, 6705 Rockledge Drive, Suite
301, Bethesda, MD 20892–7968, 301–827–
7092, yawang@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.879, Medical Library
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
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
