Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Drug Adverse Event Reporting and Recordkeeping, 5107-5109 [2018-02234]
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Federal Register / Vol. 83, No. 24 / Monday, February 5, 2018 / Notices
Based Preventive Controls for Food for
Animals; Draft Guidance for Industry;
Availability’’ that appeared in the
Federal Register of January 23, 2018.
The document announced the
availability of a draft guidance for
industry #245 entitled ‘‘Hazard Analysis
and Risk-Based Preventive Controls for
Food for Animals.’’ The document was
published with the incorrect docket
number. This document corrects that
error.
Lisa
Granger, Office of Policy and Planning,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 32, Rm.
3330, Silver Spring, MD 20993–0002,
301–796–9115.
SUPPLEMENTARY INFORMATION: In the
Federal Register of Tuesday, January 23,
2018 (83 FR 3163), in FR Doc. 2018–
01126, on page 3163, the following
correction is made:
1. On page 3163, in the first column,
in the header of the document, the
docket number is corrected to read
‘‘FDA–2018–D–0388’’.
FOR FURTHER INFORMATION CONTACT:
Dated: January 30, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–02181 Filed 2–2–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–2428]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Animal Drug
Adverse Event Reporting and
Recordkeeping
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) 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 March 7,
2018.
sradovich on DSK3GMQ082PROD with NOTICES
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–
ADDRESSES:
VerDate Sep<11>2014
18:08 Feb 02, 2018
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395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0284. Also
include the FDA docket number found
in brackets in the heading of this
document.
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
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:
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 (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
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Sfmt 4703
5107
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.
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.
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05FEN1
5108
Federal Register / Vol. 83, No. 24 / Monday, February 5, 2018 / Notices
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 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.
In the Federal Register of July 18,
2017 (82 FR 32829), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. Although one comment
was received, it was not responsive to
the four collection of information topics
solicited and therefore will not be
discussed in this document.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
FDA Form
Number of
respondents
Number of
responses
per
respondent
Total annual
responses
Average
burden
per
response
Total hours
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) .............................................
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) ..................................
N/A
5
1
5
* 0.25
1.25
1932
1932a
2301
2301
2301
2301
22
197
200
200
200
190
81
1
8.11
0.57
20.12
0.1
1,782
197
1,622
114
4,024
19
1
1
16
2
2
2
1,782
197
25,952
228
8,048
38
Total ...........................................................................................................
....................
....................
....................
....................
....................
36,246.25
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
* (15 minutes).
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity
Total hours
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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
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 § 510.301.
3 This estimate includes all recordkeeping by applicants of approved NADAs, ANADAs, and CNADAs under § 514.80(e).
We base our reporting and
recordkeeping estimates on our
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experience with adverse event reporting
for approved new animal drugs and the
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number of reports received in the
previous 3 years. Since the
E:\FR\FM\05FEN1.SGM
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Federal Register / Vol. 83, No. 24 / Monday, February 5, 2018 / Notices
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. There was a slight increase in
the estimated number of reports
submitted to FDA under total annual
responses (by 7.8 responses) and there
was a slight overall decrease in burden
hours (by 1.75 hours). This minor
fluctuation in responses and hours is
due to the normal variation in the
submission of reports to FDA, the
correction of mathematical errors, and a
change in reporting methodology
(addition of a new row to table 1 and
table 2).
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 § 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: January 30, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–02234 Filed 2–2–18; 8:45 am]
sradovich on DSK3GMQ082PROD with NOTICES
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meetings Announcement for the
Physician-Focused Payment Model
Technical Advisory Committee
Required by the Medicare Access and
CHIP Reauthorization Act of 2015
(MACRA)
ACTION:
Notice of public meetings.
This notice announces the
2018 meetings of the Physician-Focused
Payment Model Technical Advisory
Committee (hereafter referred to as ‘‘the
Committee’’) which will be held in
Washington, DC. This meeting will
include voting and deliberations on
proposals for physician-focused
payment models (PFPMs) submitted by
members of the public. All meetings are
open to the public.
DATES: The 2018 PTAC meetings will
occur on the following dates:
• Monday–Tuesday, March 26–27,
2018, from 9:00 a.m. to 5:00 p.m. ET
• Thursday–Friday, June 14–15, 2018,
from 9:00 a.m. to 5:00 p.m. ET
• Thursday–Friday, September 6–7,
2018, from 9:00 a.m. to 5:00 p.m. ET
• Monday–Tuesday, December 10–11,
2018, from 9:00 a.m. to 5:00 p.m. ET
Please note that times are subject to
change. If the times change, registrants
will be notified directly via email.
ADDRESSES: All PTAC meetings will be
held in the Great Hall of the Hubert H.
Humphrey Building, 200 Independence
Avenue SW, Washington, DC 20201.
FOR FURTHER INFORMATION CONTACT: Ann
Page, Designated Federal Official, at the
Office of Health Policy, Assistant
Secretary for Planning and Evaluation
(ASPE), U.S. Department of Health and
Human Services, 200 Independence
Ave. SW, Washington, DC 20201, (202)
690–6870.
SUPPLEMENTARY INFORMATION:
I. Purpose. The Physician-Focused
Payment Model Technical Advisory
Committee (‘‘the Committee’’) is
required by the Medicare Access and
CHIP Reauthorization Act of 2015, 42
U.S.C. 1395ee. This Committee is also
governed by provisions of the Federal
Advisory Committee Act, as amended (5
U.S.C. App.), which sets forth standards
for the formation and use of federal
advisory committees. In accordance
with its statutory mandate, the
Committee is to review physicianfocused payment model proposals and
prepare recommendations regarding
whether such models meet criteria that
were established through rulemaking by
the Secretary of Health and Human
Services (the Secretary). The Committee
SUMMARY:
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5109
is composed of 11 members appointed
by the Comptroller General.
II. Agenda. At each scheduled
meeting, the Committee will hear
presentations on PFPMs that are ready
for Committee deliberation. The
presentations will be followed by public
comment and Committee deliberation. If
the Committee completes deliberations,
voting will occur on recommendations
to the Secretary of Health and Human
Services. There will be time allocated
for public comment on agenda items.
Documents will be posted on the
Committee website and distributed on
the Committee listserv prior to the
public meeting. The agenda is subject to
change. If the agenda does change, we
will inform registrants and update the
website.
III. Meeting Attendance. These
meetings are open to the public. The
public may also attend via conference
call or view the meeting via livestream
at www.hhs.gov/live. The conference
call dial-in information will be sent to
registrants prior to the meeting.
Meeting Registration: The public may
attend the meetings in-person,
participate by phone via audio
teleconference, or view the meeting via
livestream. Space is limited and
registration is preferred in order to
attend in-person or by phone.
Registration may be completed online at
www.regonline.com/PTACMeetings
Registration.
The following information is
submitted when registering:
Name:
Company/organization name:
Postal address:
Email address:
A confirmation email will be sent to
registrants shortly after completing the
registration process.
IV. Special Accommodations. If sign
language interpretation or other
reasonable accommodation for a
disability is needed, please contact
Angela Tejeda, no later than one week
prior to the scheduled meeting. Please
submit your requests by email to
Angela.Tejeda@hhs.gov or by calling
202–401–8297.
V. Copies of the PTAC Charter and
Meeting Material. The Secretary’s
Charter for the Physician-Focused
Payment Model Technical Advisory
Committee is available on the ASPE
website at https://aspe.hhs.gov/charterphysician-focused-payment-modeltechnical-advisory-committee.
Additional material for this meeting
can be found on the ASPE PTAC
website. For updates and
announcements, please use the link to
subscribe to the ASPE PTAC email
listserv.
E:\FR\FM\05FEN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 24 (Monday, February 5, 2018)]
[Notices]
[Pages 5107-5109]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02234]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-2428]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 we) 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 March
7, 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 0910-0284.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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 (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.
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.
[[Page 5108]]
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.
In the Federal Register of July 18, 2017 (82 FR 32829), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although one comment was received, it was
not responsive to the four collection of information topics solicited
and therefore will not be discussed in this document.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Number of responses Total Average
Activity FDA Form respondents per annual burden per Total hours
respondent responses response
----------------------------------------------------------------------------------------------------------------
Medicated feed reports, Sec. N/A 5 1 5 * 0.25 1.25
510.301(a) and (b)...............
Mandatory adverse event reporting, 1932 22 81 1,782 1 1,782
21 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 1932a 197 1 197 1 197
by veterinarians and the general
public...........................
Periodic drug experience reports, 2301 200 8.11 1,622 16 25,952
Sec. 514.80(b)(4)..............
Special drug experience reports, 2301 200 0.57 114 2 228
Sec. 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 2301 190 0.1 19 2 38
statements, 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.
* (15 minutes).
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Total Average
Activity Number of records per annual burden per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Recordkeeping, Sec. 510.301 \2\......... 5 1 5 4 20
Recordkeeping, 21 U.S.C. 360b(l) and Sec. 646.70 7.19 4,649.8 14 65,097
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 reporting and 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
[[Page 5109]]
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. There was a slight
increase in the estimated number of reports submitted to FDA under
total annual responses (by 7.8 responses) and there was a slight
overall decrease in burden hours (by 1.75 hours). This minor
fluctuation in responses and hours is due to the normal variation in
the submission of reports to FDA, the correction of mathematical
errors, and a change in reporting methodology (addition of a new row to
table 1 and table 2).
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: January 30, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02234 Filed 2-2-18; 8:45 am]
BILLING CODE 4164-01-P
