Notice2024-15011
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drugs for Investigational Use
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
July 9, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 131 (Tuesday, July 9, 2024)</title>
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[Federal Register Volume 89, Number 131 (Tuesday, July 9, 2024)]
[Notices]
[Pages 56385-56386]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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 0910-0117. 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,
<a href="/cdn-cgi/l/email-protection#045456455770656262446260652a6c6c772a636b72"><span class="__cf_email__" data-cfemail="247476657750454242644240450a4c4c570a434b52">[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.
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 (<a href="https://www.fda.gov/industry/fda-esubmitter/cvm-esubmitter-programs">https://www.fda.gov/industry/fda-esubmitter/cvm-esubmitter-programs</a>).
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
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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
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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.....................
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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 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
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