[Federal Register Volume 89, Number 131 (Tuesday, July 9, 2024)]
[Notices]
[Pages 56385-56386]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-15011]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-1464]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; New Animal Drugs for 
Investigational Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA 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 August 8, 2024.

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 0910-0117. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399, 
[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.

New Animal Drugs for Investigational Use

OMB Control Number 0910-0117--Extension

    This information collection helps support implementation of Agency 
statutory and regulatory requirements regarding the approval of new 
animal drugs. FDA has the authority under the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) to approve new animal drugs. A new animal drug 
application (NADA) cannot be approved until, among other things, the 
new animal drug has been demonstrated to be safe and effective for its 
intended use(s). In order to properly test a new animal drug for an 
intended use, appropriate scientific investigations must be conducted. 
Under specific circumstances, section 512(j) of the FD&C Act (21 U.S.C. 
360b(j)) permits the use of an investigational new animal drug to 
generate data to support a NADA approval. Section 512(j) of the FD&C 
Act authorizes us to issue regulations relating to the investigational 
use of new animal drugs.
    Our regulations in part 511 (21 CFR part 511) set forth the 
conditions for investigational use of new animal drugs and require 
reporting and recordkeeping to qualify for the exemption from section 
512(a) of the FD&C Act. The information collected is necessary to 
protect the public health. We use the information to determine that 
investigational animal drugs are distributed only to qualified 
investigators, adequate drug accountability records are maintained, and 
edible food products from treated food-producing animals are safe for 
human consumption. We also use the information collected to monitor the 
validity of the studies submitted to us to support new animal drug 
approval.
    Our regulations require that certain information be submitted to us 
in a ``Notice of Claimed Investigational Exemption for a New Animal 
Drug'' (NCIE) to qualify for the exemption and to control shipment of 
the new animal drug and prevent potential abuse. We also require 
reporting by importers of investigational new animal drugs (INDs) for 
clinical investigational use in animals (Sec.  511.1(b)(9)). The 
information provided by the sponsor in the NCIE is needed to help 
ensure that the proposed investigational use of the new animal drug is 
safe and that any edible food will not be distributed without proper 
authorization from FDA. Information contained in an NCIE submission is 
monitored under our Bioresearch Monitoring Program. This program 
permits us to monitor the validity of the studies and to help ensure 
the proper use of the drugs is maintained by the investigators.
    Sponsors use eSubmitter, a secure online, question-based submission 
tool, to submit the NCIE electronically (https://www.fda.gov/industry/fda-esubmitter/cvm-esubmitter-programs).
    Description of Respondents: Respondents to this collection of 
information are persons who use new animal drugs for investigational 
purposes. INDs are used primarily by drug industry firms, academic 
institutions, and the government (i.e.,

[[Page 56386]]

sponsors of INDs). Investigators may include individuals from these 
entities, as well as research firms and members of the medical 
professions. With respect to this information collection, the term 
``respondent'' includes sponsors who are subject to user fees and 
sponsors who are not subject to user fees.
    In the Federal Register of May 2, 2024 (89 FR 35838), FDA published 
a 60-day notice requesting public comment on the proposed collection of 
information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                               Table 1--Estimated Annual Reporting Burden \1\ \2\
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                                                            Number of                      Average
         21 CFR section/activity             Number of    responses per   Total annual   burden per      Total
                                            respondents     respondent      responses     response       hours
----------------------------------------------------------------------------------------------------------------
511.1(b)(4), 511.1(b)(5) 511.1(b)(6)               257             5.70         1,466          1.12       1,634
 511.1(b)(8)(ii), and 511.1(b)(9);
 submissions of NCIE, data to obtain
 authorization, any additional
 information upon request of FDA,
 reporting of findings that may suggest
 significant hazards, and reporting by
 importers of investigational new animal
 drugs for clinical investigational use
 in animals..............................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Totals may not sum due to rounding.


                             Table 2--Estimated Annual Recordkeeping Burden \1\ \2\
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                                                         Number of                    Average burden
      21 CFR section/activity           Number of       records per    Total annual        per           Total
                                      recordkeepers     recordkeeper      records     recordkeeping      hours
----------------------------------------------------------------------------------------------------------------
511.1(a)(3), 511.1(b)(3),                       257            17.44         4,482             2.57      11,519
 511.1(b)(7), and 511.1(b)(8)(ii);
 Maintain records showing the name
 and post office address of the
 expert or expert organization to
 whom the new animal drug, or feed
 containing the same is shipped and
 the date, quantity, and batch or
 code mark of each shipment and
 delivery; maintain records of the
 investigation and all reports
 received by a sponsor from
 investigators.....................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Totals may not sum due to rounding.

    The NCIE must contain, among other things, the following specific 
information: (1) identity of the new animal drug, (2) labeling, (3) 
statement of compliance of any non-clinical laboratory studies with 
good laboratory practices, (4) name and address of each clinical 
investigator, (5) the approximate number of animals to be treated or 
amount of new animal drug(s) to be shipped, and (6) information 
regarding the use of edible tissues from investigational animals (Sec.  
511.1(b)(4)). If the new animal drug is to be used in food-producing 
animals (e.g., cattle, swine, chickens, fish, etc.), certain data must 
be submitted to us to obtain authorization for the use of edible food 
products from treated food-producing animals (Sec.  511.1(b)(5)). We 
require sponsors upon request to submit information with respect to the 
investigation to determine whether there are grounds for terminating 
the exemption (Sec.  511.1(b)(6)). We require sponsors to report 
findings that may suggest significant hazards pertinent to the safety 
of the new animal drug (Sec.  511.1(b)(8)(ii)).
    If the new animal drug is only for tests in vitro or in laboratory 
research animals, the person distributing the new animal drug must 
maintain records showing the name and post office address of the expert 
or expert organization to whom it is shipped and the date, quantity, 
and batch or code mark of each shipment and delivery for a period of 2 
years after such shipment or delivery (Sec.  511.1(a)(3) and (b)(3)).
    We require complete records of the investigation, including records 
of the receipt and disposition of each shipment or delivery of the 
investigational new animal drug (Sec.  511.1(b)(7)). We also require 
records of all reports received by a sponsor from investigators to be 
retained for 2 years after the termination of an investigational 
exemption or approval of a NADA (Sec.  511.1(b)(8)(i)).
    The estimate of the time required for reporting requirements, 
record preparation, and maintenance for this collection of information 
is based on our informal communication with industry. Based on the 
number of sponsors subject to animal drug user fees, we estimate that 
there are 257 respondents. We use this estimate throughout both tables 
to calculate the ``number of responses per respondent'' by dividing the 
total annual responses by number of respondents. The burden we 
attribute to reporting and recordkeeping activities is assumed to be 
distributed among the individual elements of the respective information 
collection activities.
    Additional information needed to make a final calculation of the 
total burden hours (i.e., the number of respondents, the number of 
recordkeepers, the number of NCIEs received, etc.) is derived from our 
records.
    Since our last renewal, there is an adjustment decrease in the 
total burden hours of 2,401, which we attribute to a decrease in the 
number of respondents, annual responses, and records.

    Dated: July 3, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-15011 Filed 7-8-24; 8:45 am]
BILLING CODE 4164-01-P