Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Drug Adverse Event Reporting and Recordkeeping, 32829-32832 [2017-14993]
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32829
Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices
These requirements are not in the
reporting burden estimate because they
are information supplied by the Federal
Government to the recipient for the
purposes of disclosure to the public (5
CFR 1320.3(c)(2)).
Types of research studies not
permitted under this regulation are also
specified, and include those intended
for immediate therapeutic, diagnostic,
or similar purposes or to determine the
safety or effectiveness of the drug in
humans for such purposes (i.e., to carry
out a clinical trial for safety or efficacy).
These studies require filing of an
investigational new drug application
under 21 CFR part 312, and the
associated information collections are
covered in OMB control number 0910–
0014.
The primary purpose of this
collection of information is to determine
whether the research studies are being
conducted in accordance with required
regulations and that human subject
safety is assured. If these studies were
not reviewed, human subjects could be
subjected to inappropriate radiation or
pharmacologic risks. Respondents to
this information collection are the
chairperson(s) of each individual RDRC,
investigators, and participants in the
studies. The burden estimates are based
on FDA’s experience with these
reporting and recordkeeping
requirements and the number of
submissions received by FDA under the
regulations over the past 3 years.
In the Federal Register of April 25,
2017 (82 FR 19052), we published a 60day notice requesting public comment
on the proposed extension of this
collection of information. No comments
were received.
We therefore estimate the burden of
this collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR Section/Form FDA
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
361.1(c)(3) (Reports) and (c)(4) (Approval); Form FDA
2914 (Membership Summary) ..........................................
361.1(c)(3) (Reports); Form FDA 2915 (Study Summary) ..
361.1(c)(8) (Adverse Events) ...............................................
69
35
10
1
14
1
69
490
10
1
3.5
* 0.5
69
1,715
5
Total ..............................................................................
........................
........................
569
........................
1,789
1 There
are no capital or operating and maintenance costs associated with the information collection.
* 30 minutes.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR Section
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
361.1(c)(2) ............................................................................
361.1(d)(5) ...........................................................................
69
35
4
14
276
490
10
* 0.75
2,760
368
Total ..............................................................................
........................
........................
766
........................
3,128
1 There
are no capital or operating and maintenance costs associated with the information collection.
* 45 minutes.
Dated: July 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–15000 Filed 7–17–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
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[Docket No. FDA–2017–N–2428]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Animal Drug
Adverse Event Reporting and
Recordkeeping
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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The Food and Drug
Administration (FDA or Agency) 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 information
collection provisions of FDA’s existing
reporting and recordkeeping
requirements for animal drug adverse
events and product/manufacturing
defects.
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 September 18,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of September 18, 2017.
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.
SUMMARY:
ADDRESSES:
Submit either electronic or
written comments on the collection of
information by September 18, 2017.
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
DATES:
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Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices
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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–
2017–N–2428 for ‘‘Animal Drug
Adverse Event Reporting and
Recordkeeping.’’ Received comments,
those filed in a timely manner (see
DATES), 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.
• 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
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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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852, 301–
796–7726, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), 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
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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.
Animal Drug Adverse Event Reporting
and Recordkeeping—21 U.S.C. 360b(l),
21 CFR 510.301 and 514.80 OMB
Control Number 0910–0284—Extension
With regard to adverse events and
product/manufacturing defects
associated with approved new animal
drugs, section 512(l) of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360b(l)) requires
applicants with approved new animal
drug applications (NADAs) and
abbreviated new animal drug
applications (ANADAs) to establish and
maintain records and reports of data
relating to experience with uses of such
drug, or with respect to animal feeds
bearing or containing such drug, to
facilitate a determination under section
512(e) as to whether there may be
grounds for suspending or withdrawing
approval of the NADA or ANADA under
section 512(e) or 512(m)(4). Sections
571(e)(3) and 512(e)(2) of the FD&C Act
(21 U.S.C. 360ccc(e)(3) and 360b(e)(2))
require that applicants with
conditionally approved new animal
drug applications (CNADAs) maintain
adequate records and make reports in
accordance with a regulation or order
issued under section 512(l). Finally,
section 512(m)(5) of the FD&C Act
requires an applicant for a license to
manufacture animal feeds bearing or
containing new animal drugs to
maintain adequate records and make
reports ‘‘as the Secretary may by general
regulation, or by order with respect to
such application, prescribe on the basis
of a finding that such records and
reports are necessary in order to enable
the Secretary to determine’’ whether
there may be grounds for suspending or
withdrawing approval of the new
animal drug under section 512(e) or a
license to manufacture animal feeds
bearing or containing new animal drugs
under section 512(m)(4).
Section 514.80 of our regulations (21
CFR 514.80) sets forth the recordkeeping
and reporting requirements for
applicants and nonapplicants of
approved NADAs and ANADAs. Section
510.301 of our regulations (21 CFR
510.301) sets forth the recordkeeping
and reporting requirements for licensed
medicated feed manufacturing facilities.
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Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices
Recordkeeping and Reporting
Requirements for Applicants of
Approved NADAs and ANADAs
Section 514.80 requires applicants to
keep records of and report to us data,
studies, and other information
concerning experience with new animal
drugs for each approved NADA and
ANADA. Following complaints from
animal owners or veterinarians or
following their own detection of a
problem, applicants are required to
submit adverse event reports and
product defect reports under
§ 514.80(b)(1), (b)(2)(i) and (ii), (b)(3),
and (b)(4)(iv)(A) on Form FDA 1932.
Form FDA 1932a (the voluntary
reporting form) is used by veterinarians
and the general public to submit adverse
event reports, product defects, and lack
of effectiveness complaints directly to
FDA. Form FDA 2301 is used by
applicants to submit the required
transmittal of periodic reports
(§ 514.80(b)(4)); special drug experience
reports (§ 514.80(b)(5)(i)); promotional
material for new animal drugs
(§ 514.80(b)(5)(ii)); and distributor
statements (§ 514.80(b)(5)(iii)). We
review the records and reports required
in § 514.80 and the voluntary reports to
facilitate a determination under section
512(e) of the FD&C Act as to whether
there may be grounds for suspending or
withdrawing approval of the new
animal drug. We have made minor
editorial revisions to Form FDA 1932a,
to clarify how to report adverse drug
events associated with compounded
products using that form. Submitters are
already reporting adverse drug events
associated with compounded products
on Form FDA 1932a. The clarifications
include: The addition of a new question,
‘‘Is this a compounded product’’; the
addition of a new field to allow the
submitter to provide product strength,
‘‘Strength of Active Ingredient(s)’’;
modifying the title of the existing field
requesting the name of manufacturer, so
that it reads, ‘‘Name of Manufacturer or
Compounding Pharmacy/Compounder
of Suspected Product’’; and a request for
contact information for the
manufacturer or compounder. We
estimate that the revisions will not
change the average amount of time
necessary to complete the form.
Recordkeeping and Reporting
Requirements for Applicants of
CNADAs
As noted, sections 571(e)(3) and
512(e)(2) of the FD&C Act require that
applicants for CNADAs maintain
adequate records and make reports in
accordance with a regulation or order
issued under section 512(l) of the FD&C
Act. Moreover, section 512(l) requires
submission of such information as
required ‘‘by general regulation, or by
order . . .’’ Conditional approval letters
explicitly establish an order requiring
the submission of postmarketing
information in accordance with the
requirements of § 514.80. Applicants
submit adverse event reports and
product defect reports on Form FDA
1932.
Recordkeeping and Reporting
Requirements for Licensed Medicated
Feed Manufacturing Facilities
Section 510.301 requires a licensed
medicated feed manufacturer to keep
records of and report to us information
concerning experience with animal
feeds bearing or containing approved
new animal drugs. Under § 510.301(a), a
licensed medicated feed manufacturer
must immediately report to us
information concerning any mixup in
the new animal drug or its labeling; any
bacterial or significant chemical,
physical, or other change or
deterioration in a drug; and any failure
of one or more distributed batches of a
drug to meet the specifications
established for it. Under § 510.301(b), a
licensed medicated feed manufacturer
must report to us within 15 working
days of receipt of information
concerning any unexpected side effect,
injury, toxicity, or sensitivity reaction or
32831
any unexpected incidence or severity
thereof, and any unusual failure of the
new animal drug to exhibit its expected
pharmacological activity. OMB initially
approved the information collection
provisions of § 510.301 under control
number 0910–0012. That approval was
subsequently consolidated into this
collection in 2004. We reviewed the
records and reports required by
§ 510.301 to facilitate a determination as
to whether there may be grounds for
suspending or withdrawing approval of
the new animal drug under section
512(e) of the FD&C Act, or grounds for
revoking a license to manufacture
medicated feed under section 512(m)(4).
Since the consolidation of the 0910–
0012 collection into this collection in
2004, we have included the estimated
number of medicated feed adverse event
reports as part of our estimate of the
number of all mandatory adverse event
reports for new animal drugs. To
improve the clarity of our estimates we
have added a row to table 1, on which
we separately report our estimates of
medicated feed reports.
The continuous monitoring of
approved NADAs, ANADAs, CNADAs,
and animal feeds bearing or containing
new animal drugs affords the primary
means by which we obtain information
regarding potential problems with the
safety and efficacy of marketed
approved new animal drugs, as well as
potential product/manufacturing
problems. Postapproval marketing
surveillance is important because data
previously submitted to us may not be
adequate as animal drug effects can
change over time and less apparent
effects may take years to manifest.
Description of respondents:
Respondents to this collection of
information are animal drug
manufacturers with approved NADAs,
ANADAs, or CNADAs, as well as
licensed commercial feed mills and
licensed mixer-feeders.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
sradovich on DSK3GMQ082PROD with NOTICES
Activity
Medicated feed reports, § 510.301(a)
and (b).
Mandatory adverse event reporting,
21 U.S.C. 360b(l); § 514.80(b)(1);
(b)(2)(i) and (ii); (b)(3); and
(b)(4)(iv)(A).
Voluntary adverse event reporting by
veterinarians and the general public.
Periodic drug experience reports,
§ 514.80(b)(4).
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Number of
responses per
respondent
Number of
respondents
FDA Form
Total annual
responses
Average burden
per response
Total hours
N/A
5
1
5
.25 (15 minutes) ...
1.25
1932
22
81
1,782
1 ...........................
1,782
1932a
197
1
197
1 ...........................
197
2301
200
8.11
1,622
16 .........................
25,952
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Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Activity
Number of
respondents
FDA Form
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
Special drug experience reports,
§ 514.80(b)(5)(i).
Submission of advertisements and
promotional
labeling,
§ 514.80(b)(5)(ii).
Submission of distributor statements,
§ 514.80(b)(5)(iii).
2301
200
0.57
114
2 ...........................
228
2301
200
20.12
4,024
2 ...........................
8,048
2301
190
0.1
19
2 ...........................
38
Total ...........................................
........................
........................
........................
........................
..............................
36,246.25
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
We base our reporting estimates on
our experience with adverse event
reporting for approved new animal
drugs and the number of reports
received in the previous 3 years.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
Recordkeeping, § 510.301 2 .................................................
Recordkeeping, 21 U.S.C. 360b(l) and § 514.80(e) 3 ..........
5
646.70
1
7.19
5
4,649.8
4
14
20
65,097
Total ..............................................................................
........................
........................
........................
........................
65,117
1 There
2 This
sradovich on DSK3GMQ082PROD with NOTICES
3 This
are no capital costs or operating and maintenance costs associated with this collection of information.
estimate includes all recordkeeping by licensed medicated feed manufacturers under § 510.301.
estimate includes all recordkeeping by applicants of approved NADAs, ANADAs, and CNADAs under § 514.80(e).
We base our recordkeeping estimates
on our experience with adverse event
reporting for approved new animal
drugs and the number of reports
received in the previous 3 years. Since
the consolidation of the 0910–0012
collection into this collection in 2004,
we have included the estimated
recordkeeping burden for medicated
feed adverse event reports as part of our
estimate of the recordkeeping burden of
all mandatory adverse event reports for
new animal drugs. To improve the
clarity of our estimates we have added
a row to table 2, on which we separately
report our recordkeeping estimate for
medicated feed adverse event reports
(20 hours).
The burden of this collection has
changed. Due to the addition of a new
row to table 1 and a new row to table
2, there was a slight increase in the
estimated number of reports submitted
to FDA under total annual responses (by
7.8 responses). The overall decrease in
burden hours (by 1.75 hours) is due to
the normal variation in the submission
of reports to FDA.
We continually strive to improve our
systems for collecting and analyzing
drug experience reports and adverse
event reports. To that end, we have
developed an electronic submission
system by which Form FDA 2301 may
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be submitted to the Agency. For Form
FDA 1932a, we have a fillable electronic
form available online, which can be
submitted by email to FDA Center for
Veterinary Medicine. We specifically
invite comment from respondents on
the utility of these reporting forms.
Electronic adverse event reporting for
approved new animal drugs (including
mandatory reporting under § 514.80(b)
and voluntary reporting) has been
approved under OMB control number
0910–0645. Reporting and
recordkeeping associated with the index
of legally marketed unapproved new
animal drugs for minor species (21 CFR
part 516) is approved under OMB
control number 0910–0620.
Dated: July 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–14993 Filed 7–17–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0920]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Health and Diet
Survey, as Used by the Food and Drug
Administration
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) 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 Health and
Diet Survey as used by FDA to gauge
and to track consumer attitudes,
awareness, knowledge, and behavior
SUMMARY:
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]]>Agencies
[Federal Register Volume 82, Number 136 (Tuesday, July 18, 2017)]
[Notices]
[Pages 32829-32832]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14993]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-2428]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Animal Drug Adverse Event Reporting and Recordkeeping
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) 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 information collection provisions of
FDA's existing reporting and recordkeeping requirements for animal drug
adverse events and product/manufacturing defects.
DATES: Submit either electronic or written comments on the collection
of information by September 18, 2017.
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 September 18, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of September 18, 2017. 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
[[Page 32830]]
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-2017-N-2428 for ``Animal Drug Adverse Event Reporting and
Recordkeeping.'' Received comments, those filed in a timely manner (see
DATES), 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.
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.gpo.gov/fdsys/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.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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.
Animal Drug Adverse Event Reporting and Recordkeeping--21 U.S.C.
360b(l), 21 CFR 510.301 and 514.80 OMB Control Number 0910-0284--
Extension
With regard to adverse events and product/manufacturing defects
associated with approved new animal drugs, section 512(l) of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b(l))
requires applicants with approved new animal drug applications (NADAs)
and abbreviated new animal drug applications (ANADAs) to establish and
maintain records and reports of data relating to experience with uses
of such drug, or with respect to animal feeds bearing or containing
such drug, to facilitate a determination under section 512(e) as to
whether there may be grounds for suspending or withdrawing approval of
the NADA or ANADA under section 512(e) or 512(m)(4). Sections 571(e)(3)
and 512(e)(2) of the FD&C Act (21 U.S.C. 360ccc(e)(3) and 360b(e)(2))
require that applicants with conditionally approved new animal drug
applications (CNADAs) maintain adequate records and make reports in
accordance with a regulation or order issued under section 512(l).
Finally, section 512(m)(5) of the FD&C Act requires an applicant for a
license to manufacture animal feeds bearing or containing new animal
drugs to maintain adequate records and make reports ``as the Secretary
may by general regulation, or by order with respect to such
application, prescribe on the basis of a finding that such records and
reports are necessary in order to enable the Secretary to determine''
whether there may be grounds for suspending or withdrawing approval of
the new animal drug under section 512(e) or a license to manufacture
animal feeds bearing or containing new animal drugs under section
512(m)(4).
Section 514.80 of our regulations (21 CFR 514.80) sets forth the
recordkeeping and reporting requirements for applicants and
nonapplicants of approved NADAs and ANADAs. Section 510.301 of our
regulations (21 CFR 510.301) sets forth the recordkeeping and reporting
requirements for licensed medicated feed manufacturing facilities.
[[Page 32831]]
Recordkeeping and Reporting Requirements for Applicants of Approved
NADAs and ANADAs
Section 514.80 requires applicants to keep records of and report to
us data, studies, and other information concerning experience with new
animal drugs for each approved NADA and ANADA. Following complaints
from animal owners or veterinarians or following their own detection of
a problem, applicants are required to submit adverse event reports and
product defect reports under Sec. 514.80(b)(1), (b)(2)(i) and (ii),
(b)(3), and (b)(4)(iv)(A) on Form FDA 1932. Form FDA 1932a (the
voluntary reporting form) is used by veterinarians and the general
public to submit adverse event reports, product defects, and lack of
effectiveness complaints directly to FDA. Form FDA 2301 is used by
applicants to submit the required transmittal of periodic reports
(Sec. 514.80(b)(4)); special drug experience reports (Sec.
514.80(b)(5)(i)); promotional material for new animal drugs (Sec.
514.80(b)(5)(ii)); and distributor statements (Sec.
514.80(b)(5)(iii)). We review the records and reports required in Sec.
514.80 and the voluntary reports to facilitate a determination under
section 512(e) of the FD&C Act as to whether there may be grounds for
suspending or withdrawing approval of the new animal drug. We have made
minor editorial revisions to Form FDA 1932a, to clarify how to report
adverse drug events associated with compounded products using that
form. Submitters are already reporting adverse drug events associated
with compounded products on Form FDA 1932a. The clarifications include:
The addition of a new question, ``Is this a compounded product''; the
addition of a new field to allow the submitter to provide product
strength, ``Strength of Active Ingredient(s)''; modifying the title of
the existing field requesting the name of manufacturer, so that it
reads, ``Name of Manufacturer or Compounding Pharmacy/Compounder of
Suspected Product''; and a request for contact information for the
manufacturer or compounder. We estimate that the revisions will not
change the average amount of time necessary to complete the form.
Recordkeeping and Reporting Requirements for Applicants of CNADAs
As noted, sections 571(e)(3) and 512(e)(2) of the FD&C Act require
that applicants for CNADAs maintain adequate records and make reports
in accordance with a regulation or order issued under section 512(l) of
the FD&C Act. Moreover, section 512(l) requires submission of such
information as required ``by general regulation, or by order . . .''
Conditional approval letters explicitly establish an order requiring
the submission of postmarketing information in accordance with the
requirements of Sec. 514.80. Applicants submit adverse event reports
and product defect reports on Form FDA 1932.
Recordkeeping and Reporting Requirements for Licensed Medicated Feed
Manufacturing Facilities
Section 510.301 requires a licensed medicated feed manufacturer to
keep records of and report to us information concerning experience with
animal feeds bearing or containing approved new animal drugs. Under
Sec. 510.301(a), a licensed medicated feed manufacturer must
immediately report to us information concerning any mixup in the new
animal drug or its labeling; any bacterial or significant chemical,
physical, or other change or deterioration in a drug; and any failure
of one or more distributed batches of a drug to meet the specifications
established for it. Under Sec. 510.301(b), a licensed medicated feed
manufacturer must report to us within 15 working days of receipt of
information concerning any unexpected side effect, injury, toxicity, or
sensitivity reaction or any unexpected incidence or severity thereof,
and any unusual failure of the new animal drug to exhibit its expected
pharmacological activity. OMB initially approved the information
collection provisions of Sec. 510.301 under control number 0910-0012.
That approval was subsequently consolidated into this collection in
2004. We reviewed the records and reports required by Sec. 510.301 to
facilitate a determination as to whether there may be grounds for
suspending or withdrawing approval of the new animal drug under section
512(e) of the FD&C Act, or grounds for revoking a license to
manufacture medicated feed under section 512(m)(4).
Since the consolidation of the 0910-0012 collection into this
collection in 2004, we have included the estimated number of medicated
feed adverse event reports as part of our estimate of the number of all
mandatory adverse event reports for new animal drugs. To improve the
clarity of our estimates we have added a row to table 1, on which we
separately report our estimates of medicated feed reports.
The continuous monitoring of approved NADAs, ANADAs, CNADAs, and
animal feeds bearing or containing new animal drugs affords the primary
means by which we obtain information regarding potential problems with
the safety and efficacy of marketed approved new animal drugs, as well
as potential product/manufacturing problems. Postapproval marketing
surveillance is important because data previously submitted to us may
not be adequate as animal drug effects can change over time and less
apparent effects may take years to manifest.
Description of respondents: Respondents to this collection of
information are animal drug manufacturers with approved NADAs, ANADAs,
or CNADAs, as well as licensed commercial feed mills and licensed
mixer-feeders.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity FDA Form Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medicated feed reports, Sec. N/A 5 1 5 .25 (15 minutes)................ 1.25
510.301(a) and (b).
Mandatory adverse event reporting, 21 1932 22 81 1,782 1............................... 1,782
U.S.C. 360b(l); Sec. 514.80(b)(1);
(b)(2)(i) and (ii); (b)(3); and
(b)(4)(iv)(A).
Voluntary adverse event reporting by 1932a 197 1 197 1............................... 197
veterinarians and the general public.
Periodic drug experience reports, Sec. 2301 200 8.11 1,622 16.............................. 25,952
514.80(b)(4).
[[Page 32832]]
Special drug experience reports, Sec. 2301 200 0.57 114 2............................... 228
514.80(b)(5)(i).
Submission of advertisements and 2301 200 20.12 4,024 2............................... 8,048
promotional labeling, Sec.
514.80(b)(5)(ii).
Submission of distributor statements, 2301 190 0.1 19 2............................... 38
Sec. 514.80(b)(5)(iii).
-----------------------------------------------------------------------------------------------------------------
Total............................. .............. .............. .............. .............. ................................ 36,246.25
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
We base our reporting estimates on our experience with adverse
event reporting for approved new animal drugs and the number of reports
received in the previous 3 years.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Recordkeeping, Sec. 510.301 5 1 5 4 20
\2\............................
Recordkeeping, 21 U.S.C. 360b(l) 646.70 7.19 4,649.8 14 65,097
and Sec. 514.80(e) \3\.......
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 65,117
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ This estimate includes all recordkeeping by licensed medicated feed manufacturers under Sec. 510.301.
\3\ This estimate includes all recordkeeping by applicants of approved NADAs, ANADAs, and CNADAs under Sec.
514.80(e).
We base our recordkeeping estimates on our experience with adverse
event reporting for approved new animal drugs and the number of reports
received in the previous 3 years. Since the consolidation of the 0910-
0012 collection into this collection in 2004, we have included the
estimated recordkeeping burden for medicated feed adverse event reports
as part of our estimate of the recordkeeping burden of all mandatory
adverse event reports for new animal drugs. To improve the clarity of
our estimates we have added a row to table 2, on which we separately
report our recordkeeping estimate for medicated feed adverse event
reports (20 hours).
The burden of this collection has changed. Due to the addition of a
new row to table 1 and a new row to table 2, there was a slight
increase in the estimated number of reports submitted to FDA under
total annual responses (by 7.8 responses). The overall decrease in
burden hours (by 1.75 hours) is due to the normal variation in the
submission of reports to FDA.
We continually strive to improve our systems for collecting and
analyzing drug experience reports and adverse event reports. To that
end, we have developed an electronic submission system by which Form
FDA 2301 may be submitted to the Agency. For Form FDA 1932a, we have a
fillable electronic form available online, which can be submitted by
email to FDA Center for Veterinary Medicine. We specifically invite
comment from respondents on the utility of these reporting forms.
Electronic adverse event reporting for approved new animal drugs
(including mandatory reporting under Sec. 514.80(b) and voluntary
reporting) has been approved under OMB control number 0910-0645.
Reporting and recordkeeping associated with the index of legally
marketed unapproved new animal drugs for minor species (21 CFR part
516) is approved under OMB control number 0910-0620.
Dated: July 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-14993 Filed 7-17-17; 8:45 am]
BILLING CODE 4164-01-P
