Research Involving Children as Subjects and Not Otherwise Approvable by an Institutional Review Board: Process for Referrals to Food and Drug Administration and Office for Human Research Protections, Guidance for Institutional Review Boards, Investigators, and Sponsors; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request, 19310-19312 [2023-06649]
Download as PDF
<![CDATA[
19310
Federal Register / Vol. 88, No. 62 / Friday, March 31, 2023 / Notices
CDC requests OMB approval for an
estimated 552 annual burden hours.
There are no costs to respondents other
than their time to participate.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents
Essentials for Childhood
(EfC) Grantees.
Total .............................
4
10
480
Key Informant Interview—Principal Investigator
Key Informant Interview—Principal Investigator/
Implementor.
Surveillance Capacity Assessment—Surveillance Lead.
Implementation Capacity Assessment ..............
Evaluation and Surveillance Survey—Surveillance Lead or Evaluator.
12
12
2
2
1
1
24
24
12
1
0.5
6
12
12
1
1
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1
6
12
........................
........................
........................
552
............................................................................
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–D–0142]
Research Involving Children as
Subjects and Not Otherwise
Approvable by an Institutional Review
Board: Process for Referrals to Food
and Drug Administration and Office for
Human Research Protections,
Guidance for Institutional Review
Boards, Investigators, and Sponsors;
Draft Guidance for Industry;
Availability; Agency Information
Collection Activities; Proposed
Collection; Comment Request
Food and Drug Administration,
HHS.
Notice of availability.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Research Involving
Children as Subjects and Not Otherwise
Approvable by an IRB: Process for
Referrals to FDA and OHRP.’’ This
guidance is intended to assist
institutional review boards (IRBs),
institutions, investigators, and sponsors
in understanding the processes used for
review of research involving children as
subjects that is not otherwise
approvable by an IRB and has been
referred to FDA, the Office for Human
Research Protections (OHRP), or both,
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:54 Mar 30, 2023
Total
burden
(in hours)
2
[FR Doc. 2023–06738 Filed 3–30–23; 8:45 am]
ACTION:
Average
burden per
response
(in hours)
Annual Reporting—Project Leads .....................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
AGENCY:
Number of
responses per
respondent
Number of
respondents
Form name
Jkt 259001
for review. When final, this guidance
will replace the final guidance issued by
FDA in December 2006 entitled,
‘‘Guidance for Clinical Investigators,
Institutional Review Boards and
Sponsors: Process for Handing Referrals
to FDA Under 21 CFR 50.54: Additional
Safeguards for Children in Clinical
Investigations’’ and the guidance issued
by the OHRP entitled ‘‘Children as
Research Subjects and the HHS ‘407’
Process,’’ issued on May 26, 2005. This
draft guidance is not final nor is it in
effect at this time.
DATES: Submit either electronic or
written comments on the draft guidance
by May 30, 2023 to ensure that the
Agency and OHRP consider your
comment on this draft guidance before
they begin work on the final version of
the guidance. Submit electronic or
written comments on the proposed
collection of information in the draft
guidance by May 30, 2023.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
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
PO 00000
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Fmt 4703
Sfmt 4703
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–
2022–D–0142 for ‘‘Research Involving
Children as Subjects and Not Otherwise
Approvable by an IRB: Process for
Referrals to FDA and OHRP, Guidance
for Institutional Review Boards,
Investigators, and Sponsors.’’ 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, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
E:\FR\FM\31MRN1.SGM
31MRN1
ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 62 / Friday, March 31, 2023 / Notices
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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500.
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 Pediatric Therapeutics, Office
of the Commissioner, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5126, Silver Spring,
MD 20993–0002; or Office for Human
Research Protections, Division of Policy
and Assurances, 1101 Wootton Pkwy.,
Suite 200, Rockville, MD 20852. Send
one self-addressed adhesive label to
assist that office in processing your
request or include a Fax number to
which the draft guidance may be sent.
See the SUPPLEMENTARY INFORMATION
section for information on electronic
access to the draft guidance.
FOR FURTHER INFORMATION CONTACT:
With regard to the draft guidance:
Donna Snyder, Office of Pediatric
Therapeutics, Office of the
Commissioner, Food and Drug
VerDate Sep<11>2014
17:54 Mar 30, 2023
Jkt 259001
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5121, Silver Spring,
MD 20993–0002, 301–796–1397,
optpediatricethics@fda.hhs.gov; or
Natalie Klein, Office for Human
Research Protections, 1101 Wootton
Pkwy., Suite 200, Rockville, MD 20852,
240–453–6900 or toll free within the
United States, 866–447–4777,
Natalie.Klein@hhs.gov.
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:
I. Background
FDA and the OHRP are announcing
the availability of a draft guidance for
IRBs, institutions, investigators, and
sponsors entitled ‘‘Research Involving
Children as Subjects and Not Otherwise
Approvable by an IRB: Process for
Referrals to FDA and OHRP, Guidance
for Institutional Review Boards,
Investigators, and Sponsors.’’ This
guidance is intended to assist IRBs,
institutions, investigators, and sponsors
in understanding the processes for
review of research involving children as
subjects that is not otherwise
approvable by an IRB and has been
referred to FDA under § 50.54 (21 CFR
50.54), OHRP under 45 CFR 46.407, or
both, for review.
The Department of Health and Human
Services (HHS) issued 45 CFR part 46,
subpart D, ‘‘Additional Protections for
Children Involved as Subjects in
Research’’ as a final rule on March 8,
1983 (48 FR 9814). FDA issued part 50,
subpart D (21 CFR part 50, subpart D),
‘‘Additional Safeguards for Children in
Clinical Investigations of Food and Drug
Administration-Regulated Products,’’ as
a final rule on February 26, 2013 (78 FR
12937). These regulations, hereinafter
referred to collectively as subpart D, are
similar, with some minor differences.
(For a full discussion of the differences
between FDA and HHS human subject
protection regulations, see 78 FR 12937–
12947.)
FDA’s part 50, subpart D regulations
apply to clinical investigations
regulated by FDA as described in 21
CFR 50.1(a). HHS regulations apply to
all research involving human subjects
conducted or supported by HHS in
accordance with 45 CFR 46.101(a). FDAregulated clinical investigations
conducted or supported by HHS are
subject to both sets of regulations. As a
result, many sponsors, investigators,
and IRBs need to be familiar and
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19311
comply with both FDA’s and HHS’s
regulations.
The draft guidance describes an
overview of the review process as it
relates to FDA referral and review
(§ 50.54), OHRP referral and review (45
CFR 46.407), joint FDA and OHRP
review, multisite research, and FDA and
OHRP review of similar research. This
draft guidance is being issued consistent
with FDA’s good guidance practices
regulation (21 CFR 10.115). The draft
guidance, when finalized, will represent
the current thinking of FDA on research
involving children as subjects not
otherwise approvable by an IRB and the
process for referrals to FDA and OHRP.
It does not establish any rights for any
person and 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.
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Federal Register / Vol. 88, No. 62 / Friday, March 31, 2023 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
Protection of Human Subjects and
Institutional Review Boards
OMB Control Number 0910–0130—
Revision
This information collection supports
FDA regulations governing requirements
for informed consent and IRBs that are
intended to protect the rights and safety
of human subjects involved in FDAregulated clinical investigations (parts
50 and 56 (21 CFR parts 50 and 56)). A
‘‘clinical investigation’’ is any
experiment that involves a test article
and one or more human subjects and is
subject to requirements for prior
submission to FDA under section 505(i)
or 520(g) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
355(i) or 360j(g)), or is not subject to
requirements for prior submission to
FDA under these sections of the FD&C
Act, but the results of which are
intended to be submitted later to, or
held for inspection by, FDA as part of
an application for a research or
marketing permit (§ 50.3).
Under § 50.54, FDA will accept IRB
referrals of clinical investigations
involving children as subjects that are
not otherwise approvable by an IRB
under part 50 subpart D. The collections
of information in parts 50 and 56 are
currently approved under OMB control
number 0910–0130; however, the
submission of records to FDA as part of
an IRB referral under § 50.54, as
recommended in the draft guidance
document, is not called for in the
regulations themselves. We are therefore
revising the information collection to
include submissions of records to the
Agency that may occur under § 50.54.
Based on a review of Agency data
regarding the frequency of IRB referrals
under § 50.54, we expect that fewer than
one such submission would be made
annually. The records that the draft
guidance recommends be sent to FDA as
part of an IRB’s referral are records that
are kept by IRBs in the ordinary course
of their business, and where necessary,
information collections related to the
creation and retention of these
documents are already approved under
OMB control number 0910–0130. We
assume that no more than 1 hour would
be needed to complete the task of
transmitting this existing information to
FDA in accordance with the draft
guidance recommendations. We invite
comment on our estimate and
assumptions.
This draft guidance also refers to
previously approved collections of
information by HHS’ OHRP under OMB
control numbers 0990–0481 and 0990–
0260. Specifically, on February 14,
2022, OMB approved the collection of
VerDate Sep<11>2014
17:54 Mar 30, 2023
Jkt 259001
information identified with the OMB
control number 0990–0481 without
change. The approved collection of
information consists of a requirement
that IRB records be submitted when an
IRB or its institution request an HHS
consultation process for proposed
research involving, respectively: (1)
pregnant women, human fetuses or
neonates; (2) prisoners; or (3) children,
as subjects that are not otherwise
approvable by an IRB.
This draft guidance also refers to
previously approved FDA collections of
information. The collections of
information in 21 CFR part 312 have
been approved under OMB control
number 0910–0014, the collections of
information in 21 CFR part 812 have
been approved under OMB control
number 0910–0078.
III. Electronic Access
Persons with access to the internet
may obtain an electronic version of the
draft guidance at either https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents or
https://www.regulations.gov.
Dated: March 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–06649 Filed 3–30–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–D–0606]
Infectious Otitis Externa Drugs for
Topical Use in Dogs; Draft Guidance
for Industry; 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 for industry (GFI) #281
entitled ‘‘Infectious Otitis Externa Drugs
for Topical Use in Dogs.’’ This draft
guidance provides recommendations to
help sponsors complete the
effectiveness, target animal safety, and
labeling technical sections of a new
animal drug application (NADA) for
infectious otitis externa drugs for topical
use in dogs.
DATES: Submit either electronic or
written comments on the draft guidance
by May 30, 2023 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
SUMMARY:
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
You may submit comments
on any guidance at any time as follows:
ADDRESSES:
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–
2023–D–0606 for ‘‘Infectious Otitis
Externa Drugs for Topical Use in Dogs.’’
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, 240–402–7500.
• 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
E:\FR\FM\31MRN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 62 (Friday, March 31, 2023)]
[Notices]
[Pages 19310-19312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06649]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-0142]
Research Involving Children as Subjects and Not Otherwise
Approvable by an Institutional Review Board: Process for Referrals to
Food and Drug Administration and Office for Human Research Protections,
Guidance for Institutional Review Boards, Investigators, and Sponsors;
Draft Guidance for Industry; Availability; Agency Information
Collection Activities; Proposed Collection; Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Research
Involving Children as Subjects and Not Otherwise Approvable by an IRB:
Process for Referrals to FDA and OHRP.'' This guidance is intended to
assist institutional review boards (IRBs), institutions, investigators,
and sponsors in understanding the processes used for review of research
involving children as subjects that is not otherwise approvable by an
IRB and has been referred to FDA, the Office for Human Research
Protections (OHRP), or both, for review. When final, this guidance will
replace the final guidance issued by FDA in December 2006 entitled,
``Guidance for Clinical Investigators, Institutional Review Boards and
Sponsors: Process for Handing Referrals to FDA Under 21 CFR 50.54:
Additional Safeguards for Children in Clinical Investigations'' and the
guidance issued by the OHRP entitled ``Children as Research Subjects
and the HHS `407' Process,'' issued on May 26, 2005. This draft
guidance is not final nor is it in effect at this time.
DATES: Submit either electronic or written comments on the draft
guidance by May 30, 2023 to ensure that the Agency and OHRP consider
your comment on this draft guidance before they begin work on the final
version of the guidance. Submit electronic or written comments on the
proposed collection of information in the draft guidance by May 30,
2023.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
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-2022-D-0142 for ``Research Involving Children as Subjects and Not
Otherwise Approvable by an IRB: Process for Referrals to FDA and OHRP,
Guidance for Institutional Review Boards, Investigators, and
Sponsors.'' 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, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your
[[Page 19311]]
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.govinfo.gov/content/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, 240-402-7500.
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 Pediatric Therapeutics, Office of the Commissioner, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5126,
Silver Spring, MD 20993-0002; or Office for Human Research Protections,
Division of Policy and Assurances, 1101 Wootton Pkwy., Suite 200,
Rockville, MD 20852. Send one self-addressed adhesive label to assist
that office in processing your request or include a Fax number to which
the draft guidance may be sent. See the SUPPLEMENTARY INFORMATION
section for information on electronic access to the draft guidance.
FOR FURTHER INFORMATION CONTACT:
With regard to the draft guidance: Donna Snyder, Office of
Pediatric Therapeutics, Office of the Commissioner, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5121, Silver
Spring, MD 20993-0002, 301-796-1397, [email protected]; or
Natalie Klein, Office for Human Research Protections, 1101 Wootton
Pkwy., Suite 200, Rockville, MD 20852, 240-453-6900 or toll free within
the United States, 866-447-4777, [email protected].
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 and the OHRP are announcing the availability of a draft
guidance for IRBs, institutions, investigators, and sponsors entitled
``Research Involving Children as Subjects and Not Otherwise Approvable
by an IRB: Process for Referrals to FDA and OHRP, Guidance for
Institutional Review Boards, Investigators, and Sponsors.'' This
guidance is intended to assist IRBs, institutions, investigators, and
sponsors in understanding the processes for review of research
involving children as subjects that is not otherwise approvable by an
IRB and has been referred to FDA under Sec. 50.54 (21 CFR 50.54), OHRP
under 45 CFR 46.407, or both, for review.
The Department of Health and Human Services (HHS) issued 45 CFR
part 46, subpart D, ``Additional Protections for Children Involved as
Subjects in Research'' as a final rule on March 8, 1983 (48 FR 9814).
FDA issued part 50, subpart D (21 CFR part 50, subpart D), ``Additional
Safeguards for Children in Clinical Investigations of Food and Drug
Administration-Regulated Products,'' as a final rule on February 26,
2013 (78 FR 12937). These regulations, hereinafter referred to
collectively as subpart D, are similar, with some minor differences.
(For a full discussion of the differences between FDA and HHS human
subject protection regulations, see 78 FR 12937-12947.)
FDA's part 50, subpart D regulations apply to clinical
investigations regulated by FDA as described in 21 CFR 50.1(a). HHS
regulations apply to all research involving human subjects conducted or
supported by HHS in accordance with 45 CFR 46.101(a). FDA-regulated
clinical investigations conducted or supported by HHS are subject to
both sets of regulations. As a result, many sponsors, investigators,
and IRBs need to be familiar and comply with both FDA's and HHS's
regulations.
The draft guidance describes an overview of the review process as
it relates to FDA referral and review (Sec. 50.54), OHRP referral and
review (45 CFR 46.407), joint FDA and OHRP review, multisite research,
and FDA and OHRP review of similar research. This draft guidance is
being issued consistent with FDA's good guidance practices regulation
(21 CFR 10.115). The draft guidance, when finalized, will represent the
current thinking of FDA on research involving children as subjects not
otherwise approvable by an IRB and the process for referrals to FDA and
OHRP. It does not establish any rights for any person and 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.
[[Page 19312]]
Protection of Human Subjects and Institutional Review Boards
OMB Control Number 0910-0130--Revision
This information collection supports FDA regulations governing
requirements for informed consent and IRBs that are intended to protect
the rights and safety of human subjects involved in FDA-regulated
clinical investigations (parts 50 and 56 (21 CFR parts 50 and 56)). A
``clinical investigation'' is any experiment that involves a test
article and one or more human subjects and is subject to requirements
for prior submission to FDA under section 505(i) or 520(g) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i) or
360j(g)), or is not subject to requirements for prior submission to FDA
under these sections of the FD&C Act, but the results of which are
intended to be submitted later to, or held for inspection by, FDA as
part of an application for a research or marketing permit (Sec. 50.3).
Under Sec. 50.54, FDA will accept IRB referrals of clinical
investigations involving children as subjects that are not otherwise
approvable by an IRB under part 50 subpart D. The collections of
information in parts 50 and 56 are currently approved under OMB control
number 0910-0130; however, the submission of records to FDA as part of
an IRB referral under Sec. 50.54, as recommended in the draft guidance
document, is not called for in the regulations themselves. We are
therefore revising the information collection to include submissions of
records to the Agency that may occur under Sec. 50.54. Based on a
review of Agency data regarding the frequency of IRB referrals under
Sec. 50.54, we expect that fewer than one such submission would be
made annually. The records that the draft guidance recommends be sent
to FDA as part of an IRB's referral are records that are kept by IRBs
in the ordinary course of their business, and where necessary,
information collections related to the creation and retention of these
documents are already approved under OMB control number 0910-0130. We
assume that no more than 1 hour would be needed to complete the task of
transmitting this existing information to FDA in accordance with the
draft guidance recommendations. We invite comment on our estimate and
assumptions.
This draft guidance also refers to previously approved collections
of information by HHS' OHRP under OMB control numbers 0990-0481 and
0990-0260. Specifically, on February 14, 2022, OMB approved the
collection of information identified with the OMB control number 0990-
0481 without change. The approved collection of information consists of
a requirement that IRB records be submitted when an IRB or its
institution request an HHS consultation process for proposed research
involving, respectively: (1) pregnant women, human fetuses or neonates;
(2) prisoners; or (3) children, as subjects that are not otherwise
approvable by an IRB.
This draft guidance also refers to previously approved FDA
collections of information. The collections of information in 21 CFR
part 312 have been approved under OMB control number 0910-0014, the
collections of information in 21 CFR part 812 have been approved under
OMB control number 0910-0078.
III. Electronic Access
Persons with access to the internet may obtain an electronic
version of the draft guidance at either https://www.fda.gov/regulatory-information/search-fda-guidance-documents or https://www.regulations.gov.
Dated: March 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-06649 Filed 3-30-23; 8:45 am]
BILLING CODE 4164-01-P
