Notice2023-16923
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Investigational New Drug Application Requirements
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 8, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) 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.
Full Text
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<title>Federal Register, Volume 88 Issue 151 (Tuesday, August 8, 2023)</title>
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[Federal Register Volume 88, Number 151 (Tuesday, August 8, 2023)]
[Notices]
[Pages 53496-53497]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-16923]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1721]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Investigational New
Drug Application Requirements
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 September 7, 2023.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0014. 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,
<a href="/cdn-cgi/l/email-protection#affffdeefcdbcec9c9efc9cbce81c7c7dc81c8c0d9"><span class="__cf_email__" data-cfemail="1d4d4f5c4e697c7b7b5d7b797c3375756e337a726b">[email protected]</span></a>.
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.
Investigational New Drug Application Requirements
OMB Control Number 0910-0014--Revision
This information collection supports implementation of provisions
of section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 355) and of the licensing provisions of the Public Health
Service Act (42 U.S.C. 201 et seq.) that govern investigational new
drugs and investigational new drug applications (INDs). Implementing
regulations are found in part 312 (21 CFR part 312) and provide for the
issuance of guidance documents under 21 CFR 10.115 to assist persons in
complying with the applicable requirements (see Sec. 312.145). The
information collection applies to all clinical investigations subject
to section 505 of the FD&C Act.
For efficiency of Agency operations, we are revising the
information collection to include burden that may be associated with
recommendations found in the guidance document entitled ``E6(R2) Good
Clinical Practice: Integrated Addendum to ICH E6(R1) (March 2018),''
currently approved in OMB control number 0910-0843. The guidance
document is intended to facilitate implementation of improved and
efficient approaches to clinical trial design, including conduct,
oversight, recording, and reporting. The recommendations in the
guidance help us ensure that sponsors of clinical trials are adhering
to requirements prescribed in FDA regulations regarding new drug
applications (NDA) (part 312), INDs (21 CFR part 314), and biological
licensing applications (BLA) (21 CFR part 601). The guidance document
is available for download from our website at <a href="https://www.fda.gov/media/93884/download">https://www.fda.gov/media/93884/download</a>.
In the Federal Register of April 11, 2023 (88 FR 21682), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:
[[Page 53497]]
Table 1--Estimated Annual Recordkeeping \1\
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Sec. 312.145: guidance
documents; recommendations in Number of Number of Total annual Average burden
ICH E6(R2) ``good clinical respondents responses per responses per response Total hours
practice'' respondent
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Section 5.0.7. Risk Reporting-- 1,880 3.9 7,362 3 22,082
Describing the Quality
Management Approach Implemented
in a Clinical Trial and
Summarizing Important
Deviations From the Predefined
Quality Tolerance Limits and
Remedial Actions Taken in the
Clinical Study Report..........
Section 5 Quality Management 1,880 1 1,880 60 112,800
(including sections 5.0.1 to
5.0.7)--Developing a Quality
Management System..............
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Total....................... .............. .............. 9,242 .............. 134,882
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Respondents to the collection of information are sponsors of
clinical trials of human drugs. Based on IND and NDA submission data,
including submissions to both FDA's Center for Drug Evaluation and
Research and the Center for Biologics Evaluation and Research, we
estimate there are 1,880 respondents to the information collection. We
assume the risk reporting recommendations and associated records
discussed in section 5 of the guidance document requires 3 hours to
complete, as reflected in table 1, row 1. In table 1, row 2, we account
for burden associated with the development of a quality management
system and associated recordkeeping also discussed in section 5 of the
guidance document. We assume it will take respondents 60 hours to
develop and implement each quality management system, as recommended.
These estimates are based on our past experiences with INDs, BLAs, and
NDAs submitted to FDA.
Since our last evaluation of the information collection burden we
attribute to recommendations applicable to activities discussed in the
guidance document, we have made no adjustments to our estimate.
Dated: August 3, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16923 Filed 8-7-23; 8:45 am]
BILLING CODE 4164-01-P
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