[Federal Register Volume 85, Number 245 (Monday, December 21, 2020)]
[Notices]
[Pages 83092-83095]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28068]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-2217]


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, 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, 
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 the reporting and 
recordkeeping requirements of our regulations concerning new animal 
drugs for investigational use.

DATES: Submit either electronic or written comments on the collection 
of information by February 19, 2021.

[[Page 83093]]


ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before February 19, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of February 19, 2021. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is 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-2020-N-2217 for ``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 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: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
PRAStaff@fda.hhs.gov.

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 Part 511

OMB Control Number 0910-0117--Extension

    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. The information collected is necessary to 
protect the

[[Page 83094]]

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.
    Reporting: 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. 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) (21 CFR 
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)). 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.
    Recordkeeping: 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)).
    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. 
Investigators may include individuals from these entities, as well as 
research firms and members of the medical professions.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                         Number of
       21 CFR section/activity           Number of     responses per   Total annual   Average burden     Total
                                        respondents     respondent       responses     per  response     hours
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511.1(b)(4); submission of NCIE.....             279            5.94           1,657               1       1,657
511.1(b)(5); submission of data to               279            0.10              28               8         224
 obtain authorization for the use of
 edible food products...............
511.1(b)(6); submission of any                   279            .001            0.28               1        0.28
 additional information upon request
 of FDA.............................
511.1(b)(8)(ii); reporting of                    279            0.05              14               2          28
 findings that may suggest
 significant hazards pertinent to
 the safety of the new animal drug..
511.1(b)(9); reporting by importers              279            0.05              14               8         112
 of investigational new animal drugs
 for clinical investigational use in
 animals............................
                                     ---------------------------------------------------------------------------
    Total...........................  ..............  ..............           1,713  ..............       2,021
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                               Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                      No. of records                      Average
       21 CFR section/activity            No. of            per        Total annual     burden per       Total
                                       recordkeepers   recordkeeper       records      recordkeeping     hours
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511.1(a)(3); maintain records                    279            0.99             276               1         276
 showing the name and post office
 address of the expert or expert
 organization to whom the new animal
 drug 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...............
511.1(b)(3); maintain records                    279            5.94           1,657               1       1,657
 showing the name and post office
 address of the expert or expert
 organization to whom the new animal
 drug or feed containing same 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...........................

[[Page 83095]]

 
511.1(b)(7); maintain records of the             279            5.94           1,657             3.5       5,800
 investigation, including records of
 the receipt and disposition of each
 shipment or delivery of the
 investigational new animal drug....
511.1(b)(8)(i); maintain records of              279            5.94           1,657             3.5       5,800
 all reports received by a sponsor
 from investigators.................
Total...............................  ..............  ..............           5,247  ..............      13,533
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    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 279 respondents. We use this estimate consistently throughout 
the table and calculate the ``number of responses per respondent'' by 
dividing the total annual responses by number of respondents. We note 
an apparent difference in the estimated number of respondents from the 
previous renewal issued in 2018. There was an error in calculating the 
number of sponsors subject to animal drug user fees in the 2018 
renewal. When calculating the number of recordkeepers, we inadvertently 
used the number of sponsors that paid user fees (i.e., those that did 
not qualify for user fee waivers) as opposed to the total number of 
sponsors subject to animal drug user fees. Both fee-paying and non-fee-
paying sponsors are respondents with respect to this information 
collection.
    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 small increase in the total burden hours which we 
attribute to an increase in the number of annual responses and records.

    Dated: December 14, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-28068 Filed 12-18-20; 8:45 am]
BILLING CODE 4164-01-P


