Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drugs for Investigational Use, 30953-30955 [2021-12197]
Download as PDF
<![CDATA[
Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0463]
Advisory Committee; Medical Imaging
Drugs Advisory Committee; Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of Federal
advisory committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Medical Imaging Drugs
Advisory Committee by the
Commissioner of Food and Drugs (the
Commissioner). The Commissioner has
determined that it is in the public
interest to renew the Medical Imaging
Drugs Advisory Committee for an
additional 2 years beyond the charter
expiration date. The new charter will be
in effect until the May 18, 2023,
expiration date.
DATES: Authority for the Medical
Imaging Drugs Advisory Committee will
expire on May 18, 2023, unless the
Commissioner formally determines that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Joyce Yu, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002, 301–837–7126,
MIDAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services pursuant to 45 CFR part 11 and
by the General Services Administration,
FDA is announcing the renewal of the
Medical Imaging Drugs Advisory
Committee (the Committee). The
Committee is a discretionary Federal
advisory committee established to
provide advice to the Commissioner.
The Committee advises the
Commissioner or designee in
discharging responsibilities as they
relate to helping to ensure safe and
effective drugs for human use and, as
required, any other product for which
FDA has regulatory responsibility.
The Committee reviews and evaluates
data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in diagnostic and therapeutic
procedures using radioactive
pharmaceuticals and contrast media
used in diagnostic radiology and makes
appropriate recommendations to the
Commissioner of Food and Drugs.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:15 Jun 09, 2021
Jkt 253001
The Committee shall consist of 12
voting members including the Chair.
Members and the Chair are selected by
the Commissioner or designee from
among authorities knowledgeable in the
fields of nuclear medicine, radiology,
epidemiology or statistics, and related
specialties. Members will be invited to
serve for overlapping terms of up to 4
years. Almost all non-Federal members
of this committee serve as Special
Government Employees. The core of
voting members may include one
technically qualified member, selected
by the Commissioner or designee, who
is identified with consumer interests
and is recommended by either a
consortium of consumer-oriented
organizations or other interested
persons. In addition to the voting
members, the Committee may include
one non-voting representative member
who is identified with industry
interests. There may also be an alternate
industry representative.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/advisory-committees/
human-drug-advisory-committees/
medical-imaging-drugs-advisorycommittee or by contacting the
Designated Federal Officer (see FOR
FURTHER INFORMATION CONTACT). In light
of the fact that no change has been made
to the committee name or description of
duties, no amendment will be made to
21 CFR 14.100.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please visit us at https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: June 3, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–12174 Filed 6–9–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–2217]
ACTION:
Notice.
The Food and Drug
Administration (FDA) 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.
SUMMARY:
Submit written comments
(including recommendations) on the
collection of information by July 12,
2021.
DATES:
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.
ADDRESSES:
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.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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). To
properly test a new animal drug for an
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.
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
30953
E:\FR\FM\10JNN1.SGM
10JNN1
30954
Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Notices
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
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 nonclinical 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
(§ 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 (§ 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 (§ 511.1(b)(6)). We require
sponsors to report findings that may
suggest significant hazards pertinent to
the safety of the new animal drug
(§ 511.1(b)(8)(ii)). We also require
reporting by importers of investigational
new animal drugs for clinical
investigational use in animals
(§ 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 (§ 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
(§ 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
(§ 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.
In the Federal Register of December
21, 2020 (85 FR 83092), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. Although one comment
was received, it was not responsive to
the four collection of information topics
solicited and therefore will not be
discussed in this document.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR Section/Activity
khammond on DSKJM1Z7X2PROD with NOTICES
511.1(b)(4); submission of NCIE .........................................
511.1(b)(5); submission of data to obtain authorization for
the use of edible food products .......................................
511.1(b)(6); submission of any additional information upon
request of FDA .................................................................
511.1(b)(8)(ii); reporting of findings that may suggest significant hazards pertinent to the safety of the new animal drug ...........................................................................
511.1(b)(9); reporting by importers of investigational new
animal drugs for clinical investigational use in animals ...
Total ..............................................................................
1 There
Number of
responses per
respondent
Total annual
responses
17:15 Jun 09, 2021
Jkt 253001
PO 00000
Total hours
279
5.94
1,657
1
1,657
279
0.10
28
8
224
279
0.001
0.28
1
0.28
279
0.05
14
2
28
279
0.05
14
8
112
........................
........................
1,713
........................
2,021
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Sep<11>2014
Average
burden per
response
Frm 00045
Fmt 4703
Sfmt 4703
E:\FR\FM\10JNN1.SGM
10JNN1
30955
Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR Section/Activity
511.1(a)(3); maintain records 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 showing the name and post
office address of the investigator 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 .........................................................
511.1(b)(7); maintain records of the 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 all reports received by a
sponsor from investigators ...............................................
Total ..............................................................................
khammond on DSKJM1Z7X2PROD with NOTICES
1 There
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
279
0.99
276
1
276
279
5.94
1,657
1
1,657
279
5.94
1,657
3.5
5,800
279
5.94
1,657
3.5
5,800
........................
........................
5,247
........................
13,533
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 nonfee-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 that we attribute to
an increase in the number of annual
responses and records.
VerDate Sep<11>2014
17:15 Jun 09, 2021
Jkt 253001
Dated: June 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–12197 Filed 6–9–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2020–E–1854 and FDA–
2020–E–1855]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; SPRAVATO
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for SPRAVATO and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of applications to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
DATES: Anyone with knowledge that any
of the dates as published (see the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by August 9, 2021.
Furthermore, any interested person may
SUMMARY:
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
December 7, 2021. See ‘‘Petitions’’ in
the SUPPLEMENTARY INFORMATION section
for more information.
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 August 9,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of August 9, 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
E:\FR\FM\10JNN1.SGM
10JNN1
]]>Agencies
[Federal Register Volume 86, Number 110 (Thursday, June 10, 2021)]
[Notices]
[Pages 30953-30955]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-12197]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-2217]
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.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) 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 July 12, 2021.
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: 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,
[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--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). To properly test a new animal drug for an
[[Page 30954]]
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 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.
In the Federal Register of December 21, 2020 (85 FR 83092), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although one comment was received, it was
not responsive to the four collection of information topics solicited
and therefore will not be discussed in this document.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section/Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
511.1(b)(4); submission of NCIE. 279 5.94 1,657 1 1,657
511.1(b)(5); submission of data 279 0.10 28 8 224
to obtain authorization for the
use of edible food products....
511.1(b)(6); submission of any 279 0.001 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 279 0.05 14 8 112
importers of investigational
new animal drugs for clinical
investigational use in animals.
-------------------------------------------------------------------------------
Total....................... .............. .............. 1,713 .............. 2,021
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 30955]]
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR Section/Activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
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
investigator 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.......................
511.1(b)(7); maintain records of 279 5.94 1,657 3.5 5,800
the 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 279 5.94 1,657 3.5 5,800
of all reports received by a
sponsor from investigators.....
-------------------------------------------------------------------------------
Total....................... .............. .............. 5,247 .............. 13,533
----------------------------------------------------------------------------------------------------------------
\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 that we
attribute to an increase in the number of annual responses and records.
Dated: June 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-12197 Filed 6-9-21; 8:45 am]
BILLING CODE 4164-01-P
