[Federal Register Volume 89, Number 86 (Thursday, May 2, 2024)]
[Notices]
[Pages 35838-35840]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09526]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 Agency) 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, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on reporting and recordkeeping requirements of 
our regulations concerning new animal drugs for investigational use.

DATES: Either electronic or written comments on the collection of 
information must be submitted by July 1, 2024.

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 July 1, 2024. 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-2024-N-1464 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; New Animal Drugs for 
Investigational Use.'' 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

[[Page 35839]]

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.

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: 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.

New Animal Drugs for Investigational Use--21 CFR 511

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 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. Investigational new animal drugs are used primarily by drug 
industry firms, academic institutions, and the government (i.e., 
sponsors of investigational new animal drugs). 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.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 35840]]



                                                   Table 1--Estimated Annual Reporting Burden \1\ \2\
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                                                                                         Number of
                      21 CFR section/activity                           Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
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511.1(b)(4), 511.1(b)(5) 511.1(b)(6) 511.1(b)(8)(ii), and                       257             5.70            1,466             1.12            1,634
 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 hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
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511.1(a)(3), 511.1(b)(3), 511.1(b)(7), and 511.1(b)(8)(ii);                     257            17.44            4,482             2.57           11,519
 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.....................................................
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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.

    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 new animal drug application (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. There is a decrease in the total burden hours of 2,401, which 
we attribute to a decrease in the number of respondents as well as the 
number of annual responses and records.

    Dated: April 29, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-09526 Filed 5-1-24; 8:45 am]
BILLING CODE 4164-01-P