83 FR 32877 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drugs for Investigational Use

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 136 (July 16, 2018)

Page Range		32877-32878
FR Document		2018-15087

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.

Federal Register, Volume 83 Issue 136 (Monday, July 16, 2018)

[Federal Register Volume 83, Number 136 (Monday, July 16, 2018)]
[Notices]
[Pages 32877-32878]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-15087]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0341]

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) 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: Fax written comments on the collection of information by August
15, 2018.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0117.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
PRAStaff@fda.hhs.gov.

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

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 an 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 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 (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 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 Bio-Research Monitoring Program. This program permits us to
monitor the validity of the studies and to 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 February 22, 2018 (83 FR 7735), 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:

[[Page 32878]]

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. 104 15.38 1,600 1 1,600
511.1(b)(5); submission of data 104 0.30 31 8 248
to obtain authorization for the
use of edible food products....
511.1(b)(6); submission of any 104 0.02 2 1 2
additional information upon
request of FDA.................
511.1(b)(8)(ii); reporting of 104 0.14 15 2 30
findings that may suggest
significant hazards pertinent
to the safety of the new animal
drug...........................
511.1(b)(9); reporting by 104 0.14 15 8 120
importers of investigational
new animal drugs for clinical
investigational use in animals.
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Total....................... .............. .............. 1,663 .............. 2,000
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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\
----------------------------------------------------------------------------------------------------------------
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 104 2.5 260 1 260
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 104 15.38 1,600 1 1,600
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.......................
511.1(b)(7); maintain records of 104 15.38 1,600 3.5 5,600
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 104 15.38 1,600 3.5 5,600
of all reports received by a
sponsor from investigators.....
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Total....................... .............. .............. 5,060 .............. 13,060
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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 104 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.
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. The burden for this information collection has changed since
the last OMB approval. We estimate an overall increase in burden that
we attribute to an increase in the number of annual responses and
records.

Dated: July 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-15087 Filed 7-13-18; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Notices 32877

respondents, including through the use New Animal Drugs for Investigational (§ 511.1(b)(5)). We require sponsors
of automated collection techniques or Use upon request to submit information
other forms of information technology. with respect to the investigation to
OMB Control Number 0910–0117—
Consideration will be given to determine whether there are grounds for
Extension
comments and suggestions submitted terminating the exemption
within 60 days of this publication. FDA has the authority under the (§ 511.1(b)(6)). We require sponsors to
Federal Food, Drug, and Cosmetic Act report findings that may suggest
Robert Sargis, (FD&C Act) to approve new animal significant hazards pertinent to the
Reports Clearance Officer. drugs. A new animal drug application safety of the new animal drug
[FR Doc. 2018–15149 Filed 7–13–18; 8:45 am] (NADA) cannot be approved until, (§ 511.1(b)(8)(ii)). We also require
BILLING CODE 4184–01–P
among other things, the new animal reporting by importers of investigational
drug has been demonstrated to be safe new animal drugs for clinical
and effective for its intended use(s). In investigational use in animals
DEPARTMENT OF HEALTH AND order to properly test a new animal drug (§ 511.1(b)(9)). The information
HUMAN SERVICES for an intended use, appropriate provided by the sponsor in the NCIE is
scientific investigations must be needed to ensure that the proposed
Food and Drug Administration conducted. Under specific investigational use of the new animal
circumstances, section 512(j) of the drug is safe and that any edible food
FD&C Act (21 U.S.C. 360b(j)) permits will not be distributed without proper
[Docket No. FDA–2018–N–0341]
the use of an investigational new animal authorization from FDA. Information
Agency Information Collection drug to generate data to support an contained in an NCIE submission is
Activities; Submission for Office of NADA approval. Section 512(j) of the monitored under our Bio-Research
Management and Budget Review; FD&C Act authorizes us to issue Monitoring Program. This program
Comment Request; New Animal Drugs regulations relating to the permits us to monitor the validity of the
investigational use of new animal drugs. studies and to ensure the proper use of
for Investigational Use
Our regulations in 21 CFR part 511 set the drugs is maintained by the
forth the conditions for investigational investigators.
AGENCY: Food and Drug Administration,
use of new animal drugs and require Recordkeeping: If the new animal
HHS.
reporting and recordkeeping. The drug is only for tests in vitro or in
ACTION: Notice. information collected is necessary to laboratory research animals, the person
protect the public health. We use the distributing the new animal drug must
SUMMARY: The Food and Drug information to determine that maintain records showing the name and
Administration (FDA) is announcing investigational animal drugs are post office address of the expert or
that a proposed collection of distributed only to qualified expert organization to whom it is
information has been submitted to the investigators, adequate drug shipped and the date, quantity, and
Office of Management and Budget accountability records are maintained, batch or code mark of each shipment
(OMB) for review and clearance under and edible food products from treated and delivery for a period of 2 years after
the Paperwork Reduction Act of 1995. food-producing animals are safe for such shipment or delivery (§ 511.1(a)(3)
human consumption. We also use the and (b)(3)). We require complete records
DATES: Fax written comments on the information collected to monitor the of the investigation, including records of
collection of information by August 15, validity of the studies submitted to us the receipt and disposition of each
2018. to support new animal drug approval. shipment or delivery of the
Reporting: Our regulations require investigational new animal drug
ADDRESSES: To ensure that comments on
that certain information be submitted to (§ 511.1(b)(7)). We also require records
the information collection are received,
us in a ‘‘Notice of Claimed of all reports received by a sponsor from
OMB recommends that written
Investigational Exemption for a New investigators to be retained for 2 years
comments be faxed to the Office of
Animal Drug’’ (NCIE) to qualify for the after the termination of an
Information and Regulatory Affairs,
exemption and to control shipment of investigational exemption or approval of
OMB, Attn: FDA Desk Officer, Fax: 202– the new animal drug and prevent
395–7285, or emailed to oira_ a new animal drug application
potential abuse. The NCIE must contain, (§ 511.1(b)(8)(i)).
submission@omb.eop.gov. All among other things, the following
comments should be identified with the Description of Respondents:
specific information: (1) Identity of the Respondents to this collection of
OMB control number 0910–0117. Also new animal drug, (2) labeling, (3)
include the FDA docket number found information are persons who use new
statement of compliance of any animal drugs for investigational
in brackets in the heading of this nonclinical laboratory studies with good
document. purposes. Investigational new animal
laboratory practices, (4) name and drugs are used primarily by drug
FOR FURTHER INFORMATION CONTACT: address of each clinical investigator, (5) industry firms, academic institutions,
Amber Sanford, Office of Operations, the approximate number of animals to and the government. Investigators may
Food and Drug Administration, Three be treated or amount of new animal include individuals from these entities,
White Flint North, 10A–12M, 11601 drug(s) to be shipped, and (6) as well as research firms and members
Landsdown St., North Bethesda, MD information regarding the use of edible of the medical professions.
tissues from investigational animals
sradovich on DSK3GMQ082PROD with NOTICES

20852, 301–796–8867, PRAStaff@ In the Federal Register of February
fda.hhs.gov. (§ 511.1(b)(4) (21 CFR 511.1(b)(4)). If the 22, 2018 (83 FR 7735), FDA published
new animal drug is to be used in food- a 60-day notice requesting public
SUPPLEMENTARY INFORMATION: In producing animals, e.g., cattle, swine, comment on the proposed collection of
compliance with 44 U.S.C. 3507, FDA chickens, fish, etc., certain data must be information. No comments were
has submitted the following proposed submitted to us to obtain authorization received.
collection of information to OMB for for the use of edible food products from FDA estimates the burden of this
review and clearance. treated food-producing animals collection of information as follows:

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Document Created: 2018-07-14 00:53:49
Document Modified: 2018-07-14 00:53:49

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by August 15, 2018.
Contact		Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected]
FR Citation		83 FR 32877

83 FR 32877 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drugs for Investigational Use

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 136 (July 16, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration