Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drugs for Investigational Use, 83092-83095 [2020-28068]
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Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Notices
TABLE 1—CERTIFICATES AND USES
Type of certificate
Use
‘‘Supplementary Information Certificate to Foreign Government Requests‘‘.
‘‘Exporter’s Certification Statement Certificate to Foreign Government‘‘.
‘‘Exporter’s Certification Statement Certificate to Foreign Government
(For Human Tissue Intended for Transplantation)‘‘..
‘‘Supplementary Information Certificate of Exportability Requests‘‘ ........
Exporter’s Certification Statement Certificate of Exportability‘‘. ...............
‘‘Supplementary Information Certificate of a Pharmaceutical Product‘‘ ...
‘‘Exporter’s Certification Statement Certificate of a Pharmaceutical
Product‘‘.
‘‘Supplementary Information Non-Clinical Research Use Only Certificate‘‘.
‘‘Exporter’s Certification Statement (Non-Clinical Research Use Only)‘‘
Appropriate centers within FDA
review product information submitted
by firms in support of the firms’
certificate requests. We rely on
respondents to certify their compliance
with all applicable requirements of the
FD&C Act both at the time the
certification request is submitted to FDA
and at the time the certification is
submitted to the respective foreign
government. Information regarding
FDA’s Export Certificates may be found
on our website at https://www.fda.gov/
For the export of products legally marketed in the United States.
For the export of products not approved for marketing in the United
States (unapproved products) that meet the requirements of sections
801(e) or 802 of the FD&C Act.
Conforms to the format established by the World Health Organization
and is intended for use by the importing country when the product in
question is under consideration for a product license that will authorize its importation and sale or for renewal, extension, amending, or
reviewing a license.
For the export of a non-clinical research use only product, material, or
component that is not intended for human use and which may be
marketed in, and legally exported from the United States under the
FD&C Act.
regulatory-information/search-fdaguidance-documents/fda-exportcertificates.
On September 16, 2020, we submitted
an information collection request to the
Office of Management and Budget
(OMB) to revise certain data elements as
may be applicable under the
Coronavirus Aid, Relief, and Economic
Security Act (CARES Act). Because
Section 3856 of the CARES Act
contained immediately effective
provisions obligating FDA to review and
process certification requests, we
requested emergency processing by
OMB under 5 CFR 1320.13 for the
respective information collection. Our
information collection request was
granted by OMB on September 29, 2020.
Therefore, in accordance with 5 CFR
1320.8(d)(1), we invite comment on the
burden we attribute to the information
collection, which we estimate as
follows:
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN1
Number of
Respondents
FDA center
Center
Center
Center
Center
1
for
for
for
for
Number of
Responses
per Respondent
Total Anual
responses
Average burden per
response
Total hours
Biologics Evaluation and Research ....................
Devices and Radiological Health .......................
Drug Evaluation and Research ..........................
Veterinary Medicine ............................................
2,651
11,175
3,680
1,925
1
1
1
1
2,651
11,175
3,680
1,925
1
2
1
1
2,651
22,350
3,680
1,925
Total ..............................................................................
........................
........................
........................
........................
30,606
There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on our current evaluation of the
information collection, we have made
no adjustments since our last request for
OMB review and approval.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: December 14, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[Docket No. FDA–2020–N–2217]
[FR Doc. 2020–28064 Filed 12–18–20; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration
Agency Information Collection
Activities; Proposed Collection;
Comment Request; New Animal Drugs
for Investigational Use
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing an opportunity for public
comment on the proposed collection of
SUMMARY:
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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.
Submit either electronic or
written comments on the collection of
information by February 19, 2021.
DATES:
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Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Notices
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.
ADDRESSES:
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
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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-201509-18/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
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83093
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
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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.
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
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
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 ..............
279
5.94
1,657
1
1,657
279
0.10
28
8
224
279
.001
0.28
1
0.28
279
0.05
14
2
28
279
0.05
14
8
112
Total ....................................................................................
........................
........................
1,713
........................
2,021
Average
burden per
recordkeeping
Total hours
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR section/activity
No. of recordkeepers
No. of records
per recordkeeper
279
0.99
276
1
276
279
5.94
1,657
1
1,657
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 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 ...............................................................
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Total annual
records
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Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
21 CFR section/activity
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 ...........................................................................................
1 There
No. of recordkeepers
No. of records
per recordkeeper
279
5.94
279
........................
5.94
........................
Average
burden per
recordkeeping
Total hours
1,657
3.5
5,800
1,657
5,247
3.5
........................
5,800
13,533
Total annual
records
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 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
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–P–1650]
Determination That DOBUTREX
(Dobutamine Hydrochloride),
Equivalent 12.5 Milligram Base/
Milliliter, Was Not Withdrawn From
Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that DOBUTREX
(dobutamine hydrochloride), equivalent
(eq) 12.5 milligram (mg) base/milliliter
(mL), was not withdrawn from sale for
reasons of safety or effectiveness. This
determination means that FDA will not
begin procedures to withdraw approval
of abbreviated new drug applications
(ANDAs) that refer to this drug product,
and it will allow FDA to continue to
approve ANDAs that refer to the
product as long as they meet relevant
legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT:
Jessica Tierney, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6213,
Silver Spring, MD 20993–0002, 301–
796–9120, Jessica.Tierney@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
SUMMARY:
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do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
DOBUTREX (dobutamine
hydrochloride), eq 12.5 mg base/mL, is
the subject of NDA 017820, held by Eli
Lilly and Co., and initially approved on
July 18, 1978. DOBUTREX is indicated
for when parenteral therapy is necessary
for inotropic support in the short-term
treatment of adults with cardiac
decompensation due to depressed
contractility resulting either from
organic heart disease or from cardiac
surgical procedures. DOBUTREX
(dobutamine hydrochloride), eq 12.5 mg
base/mL, is currently listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Cardinal Health submitted a citizen
petition dated July 9, 2020 (Docket No.
FDA–2020–P–1650), under 21 CFR
10.30, requesting that the Agency
determine whether DOBUTREX
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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,
[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 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\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section/activity Number of responses per Total annual Average burden Total
respondents respondent responses per response hours
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
No. of records Average
21 CFR section/activity No. of per Total annual burden per Total
recordkeepers recordkeeper records recordkeeping hours
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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
