Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reporting Associated With New Animal Drug Applications and Veterinary Master Files, 29866-29867 [2019-13430]
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29866
Federal Register / Vol. 84, No. 122 / Tuesday, June 25, 2019 / Notices
Reporting Associated With New Animal
Drug Applications (NADA) and
Veterinary Master Files—21 CFR 514.1,
514.4, 514.5, 514.6, 514.8, 514.11, and
558.5
the EA based on Agency comments
(between 40 to 60 hours), for a total
preparation time of 180 hours.
Based on a current review of the
information collection, we have made
no adjustments to the currently
approved estimate.
Dated: June 19, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–13434 Filed 6–24–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–0482]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Reporting
Associated With New Animal Drug
Applications and Veterinary Master
Files
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.
DATES: Fax written comments on the
collection of information by July 25,
2019.
SUMMARY:
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 0910–0032. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
khammond on DSKBBV9HB2PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, 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.
VerDate Sep<11>2014
20:35 Jun 24, 2019
Jkt 247001
OMB Control Number 0910–0032—
Extension
Under section 512(b)(1) of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360b(b)(1)), any person
may file a new animal drug application
(NADA) seeking our approval to legally
market a new animal drug. Section
512(b)(1) of the FD&C Act sets forth the
information required to be submitted in
a NADA. Sections 514.1, 514.4, 514.6,
514.8, and 514.11 of our regulations (21
CFR 514.1, 514.4, 514.6, 514.8, and
514.11) further specify the information
that the NADA must contain. The
application must include safety and
effectiveness data, proposed labeling,
product manufacturing information, and
where necessary, complete information
on food safety (including microbial food
safety) and any methods used to
determine residues of drug chemicals in
edible tissue from food producing
animals. FDA Guidance for Industry
#152 outlines a risk assessment
approach for evaluating the microbial
food safety of antimicrobial new animal
drugs. We request that applicants utilize
Form FDA 356V, as appropriate, to
ensure efficient and accurate processing
of information to support new animal
drug approval.
Under section 512(b)(3) of the FD&C
Act, any person intending to file a
NADA or supplemental NADA or a
request for an investigational exemption
under section 512(j) of the FD&C Act is
entitled to one or more conferences with
us prior to making a submission.
Section 514.5 of our regulations (21 CFR
514.5) describes the procedures for
requesting, conducting, and
documenting presubmission
conferences. We have found that these
meetings have increased the efficiency
of the drug development and drug
review processes. We encourage
sponsors to submit data for review at the
most appropriate and productive times
in the drug development process. Rather
than submitting all data for review as
part of a complete application, we have
found that the submission of data
supporting discrete technical sections
during the investigational phase of the
new animal drug is the most appropriate
and productive. This ‘‘phased review’’
of data submissions has created
efficiencies for both us and the animal
pharmaceutical industry.
Additionally, we have found that
various uses of veterinary master files
have increased the efficiency of the drug
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
development and drug review processes
for both us and the animal
pharmaceutical industry. A veterinary
master file is a repository for submission
to FDA’s Center for Veterinary Medicine
of confidential detailed information
about facilities, processes, or articles
used in the manufacturing, processing,
packaging, and storing of one or more
veterinary drugs. The benefits of
veterinary master files include
confidential exchange of information
with FDA, a process for reporting
information outside of a NADA or an
investigational new animal drug (INAD)
file, as well as an opportunity for
increased communication with FDA
during early stages of product
development. Respondents may choose
to use veterinary master files to provide
and organize confidential detailed
information to the Agency. A holder of
a veterinary master file may also
authorize other parties to reference
information in the veterinary master file
without disclosing information in the
file to those parties. Veterinary master
files can be used as repositories for
information that can be referenced in
multiple submissions to the Agency,
thus minimizing paperwork burden.
Veterinary master files are already used
by the animal pharmaceutical industry
in support of information being
submitted for NADAs, abbreviated new
animal drug applications (ANADAs),
INAD files, and generic investigational
new animal drug (JINAD) files. In
previous information collection
requests, we have included the time
necessary to compile and submit such
information to veterinary master files
within the burden estimates provided
for applications and amended
applications (for NADAs and INAD
files) and abbreviated applications and
amended abbreviated applications (for
ANADAs and JINAD files), respectively.
We are now combining the time
necessary to compile and submit such
information to veterinary master files
within the burden estimates provided in
this collection of information.
We are also developing new
approaches to permit more complex
uses of veterinary master files to
facilitate the development of animal
drug products. We expect respondents
will want to use veterinary master files
to submit information to us for review
and consultation during all phases of
animal drug product development
(including product development that
precedes the establishment of an INAD
file or the submission of a NADA). This
information could include information
about processes, facilities, or articles
used in the manufacturing, processing,
E:\FR\FM\25JNN1.SGM
25JNN1
29867
Federal Register / Vol. 84, No. 122 / Tuesday, June 25, 2019 / Notices
packaging, and storing of veterinary
drugs and drug substances. Information
submitted to FDA through a veterinary
master file could also include drug
characterization, methods, protocols, or
other relevant information. In this
request for OMB review, we seek
approval of an increased use of
veterinary master files by respondents to
submit additional information to us for
review and consultation during all
phases of animal drug product
development (including product
development that precedes the
establishment of an INAD file or the
submission of a NADA). To account for
an expected increase in reporting
burden hours associated with the
increased use of veterinary master files
by respondents, we are separately
estimating in table 1, row 10, the burden
of the use of veterinary master files
during all phases of product
development (including product
development that precedes the
establishment of an INAD file or the
submission of a NADA).
Finally, § 558.5(i) of our regulations
(21 CFR 558.5(i)) describes the
procedure for requesting a waiver of the
labeling requirements of § 558.5(h) in
the event that there is evidence to
indicate that it is unlikely a new animal
drug would be used in the manufacture
of a liquid medicated feed.
The reporting associated with NADAs
and related submissions is necessary to
ensure that new animal drugs are in
compliance with section 512(b)(1) of the
FD&C Act. We use the information
collected to review the data, labeling,
and manufacturing controls and
procedures to evaluate the safety and
effectiveness of the proposed new
animal drug.
Description of Respondents:
Respondents include persons
developing, manufacturing, and/or
researching new animal drugs.
In the Federal Register of February
15, 2019 (84 FR 4479), 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:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section; activity
514.1 & 514.6; applications and amended applications ......
514.1(b)(8) and 514.8(c)(1) 2; evidence to establish safety
and effectiveness .............................................................
514.5(b), (d), (f); requesting presubmission conferences ...
514.8(b); manufacturing changes to an approved application ....................................................................................
514.8(c)(1); labeling and other changes to an approved
application ........................................................................
514.8(c)(2) & (3); labeling and other changes to an approved application ............................................................
514.11; submission of data, studies and other information
558.5(i); requirements for liquid medicated feed .................
Form FDA 356V ...................................................................
Use of veterinary master files during all phases of product
development (including product development that precedes the establishment of an INAD file or the submission of an NADA) .............................................................
Total ..............................................................................
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
182
0.05
9
212
1,908
182
182
0.10
0.49
18
89
90
50
1,620
4,450
182
1.40
255
35
8,925
182
0.05
9
71
639
182
182
182
182
0.43
0.09
0.01
2.92
78
16
2
531
20
1
5
5
1,560
16
10
2,655
15
1
15
20
300
........................
........................
1,022
........................
22,083
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
and supplements regarding antimicrobial animal drugs that use a recommended approach to assessing antimicrobial concerns as
part of the overall pre-approval safety evaluation.
khammond on DSKBBV9HB2PROD with NOTICES
2 NADAs
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our previous estimates.
However, as discussed, we have
separately estimated the burden of the
‘‘Use of veterinary master files during
all phases of product development
(including product development that
precedes the establishment of an INAD
file or the submission of an NADA)’’ in
table 1, line 10. We base our estimate of
the total annual responses for the use of
veterinary master files on such uses
initiated during calendar year 2018. We
base our estimate of the hours per
response upon our experience with the
respondents’ use of veterinary master
files. We estimate that the time it takes
to compile information and submit it to
a veterinary master file will vary from
VerDate Sep<11>2014
20:35 Jun 24, 2019
Jkt 247001
1 to 50 hours depending on the
complexity of the information;
therefore, we are estimating on average
the burden per response to be 20 hours.
Accordingly, our estimated burden for
the information collection reflects an
overall increase of 124 hours and a
corresponding increase of 14 responses.
Dated: June 19, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–4534]
Reducing Microbial Food Safety
Hazards in the Production of Seed for
Sprouting: Draft Guidance for Industry;
Availability
AGENCY:
[FR Doc. 2019–13430 Filed 6–24–19; 8:45 am]
HHS.
BILLING CODE 4164–01–P
ACTION:
PO 00000
Food and Drug Administration,
Notice of availability.
The Food and Drug
Administration (FDA or we) is
announcing the availability of a draft
guidance for industry entitled
‘‘Reducing Microbial Food Safety
Hazards in the Production of Seed for
SUMMARY:
Frm 00029
Fmt 4703
Sfmt 4703
E:\FR\FM\25JNN1.SGM
25JNN1
]]>Agencies
[Federal Register Volume 84, Number 122 (Tuesday, June 25, 2019)]
[Notices]
[Pages 29866-29867]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13430]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-0482]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Reporting Associated
With New Animal Drug Applications and Veterinary Master Files
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 July
25, 2019.
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 0910-0032.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[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.
Reporting Associated With New Animal Drug Applications (NADA) and
Veterinary Master Files--21 CFR 514.1, 514.4, 514.5, 514.6, 514.8,
514.11, and 558.5
OMB Control Number 0910-0032--Extension
Under section 512(b)(1) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360b(b)(1)), any person may file a new animal
drug application (NADA) seeking our approval to legally market a new
animal drug. Section 512(b)(1) of the FD&C Act sets forth the
information required to be submitted in a NADA. Sections 514.1, 514.4,
514.6, 514.8, and 514.11 of our regulations (21 CFR 514.1, 514.4,
514.6, 514.8, and 514.11) further specify the information that the NADA
must contain. The application must include safety and effectiveness
data, proposed labeling, product manufacturing information, and where
necessary, complete information on food safety (including microbial
food safety) and any methods used to determine residues of drug
chemicals in edible tissue from food producing animals. FDA Guidance
for Industry #152 outlines a risk assessment approach for evaluating
the microbial food safety of antimicrobial new animal drugs. We request
that applicants utilize Form FDA 356V, as appropriate, to ensure
efficient and accurate processing of information to support new animal
drug approval.
Under section 512(b)(3) of the FD&C Act, any person intending to
file a NADA or supplemental NADA or a request for an investigational
exemption under section 512(j) of the FD&C Act is entitled to one or
more conferences with us prior to making a submission. Section 514.5 of
our regulations (21 CFR 514.5) describes the procedures for requesting,
conducting, and documenting presubmission conferences. We have found
that these meetings have increased the efficiency of the drug
development and drug review processes. We encourage sponsors to submit
data for review at the most appropriate and productive times in the
drug development process. Rather than submitting all data for review as
part of a complete application, we have found that the submission of
data supporting discrete technical sections during the investigational
phase of the new animal drug is the most appropriate and productive.
This ``phased review'' of data submissions has created efficiencies for
both us and the animal pharmaceutical industry.
Additionally, we have found that various uses of veterinary master
files have increased the efficiency of the drug development and drug
review processes for both us and the animal pharmaceutical industry. A
veterinary master file is a repository for submission to FDA's Center
for Veterinary Medicine of confidential detailed information about
facilities, processes, or articles used in the manufacturing,
processing, packaging, and storing of one or more veterinary drugs. The
benefits of veterinary master files include confidential exchange of
information with FDA, a process for reporting information outside of a
NADA or an investigational new animal drug (INAD) file, as well as an
opportunity for increased communication with FDA during early stages of
product development. Respondents may choose to use veterinary master
files to provide and organize confidential detailed information to the
Agency. A holder of a veterinary master file may also authorize other
parties to reference information in the veterinary master file without
disclosing information in the file to those parties. Veterinary master
files can be used as repositories for information that can be
referenced in multiple submissions to the Agency, thus minimizing
paperwork burden. Veterinary master files are already used by the
animal pharmaceutical industry in support of information being
submitted for NADAs, abbreviated new animal drug applications (ANADAs),
INAD files, and generic investigational new animal drug (JINAD) files.
In previous information collection requests, we have included the time
necessary to compile and submit such information to veterinary master
files within the burden estimates provided for applications and amended
applications (for NADAs and INAD files) and abbreviated applications
and amended abbreviated applications (for ANADAs and JINAD files),
respectively. We are now combining the time necessary to compile and
submit such information to veterinary master files within the burden
estimates provided in this collection of information.
We are also developing new approaches to permit more complex uses
of veterinary master files to facilitate the development of animal drug
products. We expect respondents will want to use veterinary master
files to submit information to us for review and consultation during
all phases of animal drug product development (including product
development that precedes the establishment of an INAD file or the
submission of a NADA). This information could include information about
processes, facilities, or articles used in the manufacturing,
processing,
[[Page 29867]]
packaging, and storing of veterinary drugs and drug substances.
Information submitted to FDA through a veterinary master file could
also include drug characterization, methods, protocols, or other
relevant information. In this request for OMB review, we seek approval
of an increased use of veterinary master files by respondents to submit
additional information to us for review and consultation during all
phases of animal drug product development (including product
development that precedes the establishment of an INAD file or the
submission of a NADA). To account for an expected increase in reporting
burden hours associated with the increased use of veterinary master
files by respondents, we are separately estimating in table 1, row 10,
the burden of the use of veterinary master files during all phases of
product development (including product development that precedes the
establishment of an INAD file or the submission of a NADA).
Finally, Sec. 558.5(i) of our regulations (21 CFR 558.5(i))
describes the procedure for requesting a waiver of the labeling
requirements of Sec. 558.5(h) in the event that there is evidence to
indicate that it is unlikely a new animal drug would be used in the
manufacture of a liquid medicated feed.
The reporting associated with NADAs and related submissions is
necessary to ensure that new animal drugs are in compliance with
section 512(b)(1) of the FD&C Act. We use the information collected to
review the data, labeling, and manufacturing controls and procedures to
evaluate the safety and effectiveness of the proposed new animal drug.
Description of Respondents: Respondents include persons developing,
manufacturing, and/or researching new animal drugs.
In the Federal Register of February 15, 2019 (84 FR 4479), 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:
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
----------------------------------------------------------------------------------------------------------------
514.1 & 514.6; applications and 182 0.05 9 212 1,908
amended applications...........
514.1(b)(8) and 514.8(c)(1) \2\; 182 0.10 18 90 1,620
evidence to establish safety
and effectiveness..............
514.5(b), (d), (f); requesting 182 0.49 89 50 4,450
presubmission conferences......
514.8(b); manufacturing changes 182 1.40 255 35 8,925
to an approved application.....
514.8(c)(1); labeling and other 182 0.05 9 71 639
changes to an approved
application....................
514.8(c)(2) & (3); labeling and 182 0.43 78 20 1,560
other changes to an approved
application....................
514.11; submission of data, 182 0.09 16 1 16
studies and other information..
558.5(i); requirements for 182 0.01 2 5 10
liquid medicated feed..........
Form FDA 356V................... 182 2.92 531 5 2,655
Use of veterinary master files 15 1 15 20 300
during all phases of product
development (including product
development that precedes the
establishment of an INAD file
or the submission of an NADA)..
-------------------------------------------------------------------------------
Total....................... .............. .............. 1,022 .............. 22,083
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ NADAs and supplements regarding antimicrobial animal drugs that use a recommended approach to assessing
antimicrobial concerns as part of the overall pre-approval safety evaluation.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our previous
estimates. However, as discussed, we have separately estimated the
burden of the ``Use of veterinary master files during all phases of
product development (including product development that precedes the
establishment of an INAD file or the submission of an NADA)'' in table
1, line 10. We base our estimate of the total annual responses for the
use of veterinary master files on such uses initiated during calendar
year 2018. We base our estimate of the hours per response upon our
experience with the respondents' use of veterinary master files. We
estimate that the time it takes to compile information and submit it to
a veterinary master file will vary from 1 to 50 hours depending on the
complexity of the information; therefore, we are estimating on average
the burden per response to be 20 hours. Accordingly, our estimated
burden for the information collection reflects an overall increase of
124 hours and a corresponding increase of 14 responses.
Dated: June 19, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13430 Filed 6-24-19; 8:45 am]
BILLING CODE 4164-01-P
