
[Federal Register Volume 88, Number 151 (Tuesday, August 8, 2023)]
[Notices]
[Pages 53496-53497]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-16923]


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

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.

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

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 https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. 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, 
[email protected].

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 https://www.fda.gov/media/93884/download.
    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\
----------------------------------------------------------------------------------------------------------------
    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
----------------------------------------------------------------------------------------------------------------
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..............
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............           9,242  ..............         134,882
----------------------------------------------------------------------------------------------------------------
\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


