Document ID: FDA-2014-N-1721-0021
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational
New Drug Application Requirements
Posted Date: 2023-04-11T04:00Z

[Federal Register Volume 88, Number 69 (Tuesday, April 11, 2023)]
[Notices]
[Pages 21682-21683]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07529]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1721]

Agency Information Collection Activities; Proposed Collection; 
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 an opportunity for public comment on the proposed collection 
of certain information by the Agency. Under the Paperwork Reduction Act 
of 1995 (PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
and to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the information collection associated with 
the guidance ``E6(R2) Good Clinical Practice: Integrated Addendum to 
ICH E6(R1).''

DATES: Either electronic or written comments on the collection of 
information must be submitted by June 12, 2023.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of June 12, 2023. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are received on or before that date.

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-2014-N-1721 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Investigational New Drug 
Application Requirements.'' Received comments, those filed in a timely 
manner (see ADDRESSES), 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 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.

[[Page 21683]]

    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.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the 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, including 
each proposed extension of an existing 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.

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 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 https://www.fda.gov/media/93884/download.
    FDA estimates the burden of the information collection as follows:

                                   Table 1--Estimated Annual Recordkeeping \1\
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    Sec.   312.145: Guidance
  Documents; Recommendations in      Number of       Number of     Total annual       Average
   ICH E6(R2) ``Good Clinical       respondents    responses per     responses      burden per      Total hours
           Practice''                               respondent                       response
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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.

    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 (sponsors of clinical trials of human drugs) 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.
    Since last OMB approval of the information collection, we have made 
no adjustments to burden we attribute to recommendations that may be 
applicable to activities discussed in the guidance document.

    Dated: April 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-07529 Filed 4-10-23; 8:45 am]
BILLING CODE 4164-01-P