Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drugs for Investigational Use, 32877-32878 [2018-15087]
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Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Notices
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2018–15149 Filed 7–13–18; 8:45 am]
BILLING CODE 4184–01–P
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.
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:
Fax written comments on the
collection of information by August 15,
2018.
DATES:
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.
ADDRESSES:
sradovich on DSK3GMQ082PROD with NOTICES
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.
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:
VerDate Sep<11>2014
17:31 Jul 13, 2018
Jkt 244001
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
(§ 511.1(b)(4) (21 CFR 511.1(b)(4)). If the
new animal drug is to be used in foodproducing 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
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
32877
(§ 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 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 (§ 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 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:
E:\FR\FM\16JYN1.SGM
16JYN1
32878
Federal Register / Vol. 83, No. 136 / Monday, July 16, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section/activity
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
Average
burden per
response
Total annual
responses
Total hours
104
15.38
1,600
1
1,600
104
0.30
31
8
248
104
0.02
2
1
2
104
0.14
15
2
30
104
0.14
15
8
120
........................
........................
1,663
........................
2,000
are no capital costs or operating and maintenance costs associated with this collection of information.
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 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 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 ..............................................................................
sradovich on DSK3GMQ082PROD with NOTICES
1.There
Number of
records
per
recordkeeper
Average
burden
per
recordkeeping
Total
annual
records
Total
hours
104
2.5
260
1
260
104
15.38
1,600
1
1,600
104
15.38
1,600
3.5
5,600
104
15.38
1,600
3.5
5,600
........................
........................
5,060
........................
13,060
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
VerDate Sep<11>2014
17:31 Jul 13, 2018
Jkt 244001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–2515]
Hypertension: Conducting Studies of
Drugs To Treat Patients on a
Background of Multiple
Antihypertensive Drugs; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Hypertension: Conducting Studies of
Drugs to Treat Patients on a Background
of Multiple Antihypertensive Drugs.’’
This draft guidance is intended to
clarify the recommended approach for
sponsors developing drugs to treat
hypertension for patients who are on a
background of multiple
antihypertensive drugs.
DATES: Submit either electronic or
written comments on the draft guidance
by September 14, 2018 to ensure that
the Agency considers your comment on
this draft guidance before it begins work
on the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
E:\FR\FM\16JYN1.SGM
16JYN1
]]>Agencies
[Federal Register Volume 83, Number 136 (Monday, July 16, 2018)]
[Notices]
[Pages 32877-32878]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15087]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 [email protected]. 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,
[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
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.
-------------------------------------------------------------------------------
Total....................... .............. .............. 1,663 .............. 2,000
----------------------------------------------------------------------------------------------------------------
\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.....
-------------------------------------------------------------------------------
Total....................... .............. .............. 5,060 .............. 13,060
----------------------------------------------------------------------------------------------------------------
\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
