83 FR 5107 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Drug Adverse Event Reporting and Recordkeeping

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 24 (February 5, 2018)

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.

[Federal Register Volume 83, Number 24 (Monday, February 5, 2018)]
[Notices]
[Pages 5107-5109]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-02234]


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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.

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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\
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                                                               Number of
                                                  Number of    responses      Total       Average
             Activity                 FDA Form   respondents      per         annual    burden  per  Total hours
                                                               respondent   responses     response
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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)................
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    Total.........................  ...........  ...........  ...........  ...........  ...........    36,246.25
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\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\
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                                                             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\...........................
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Total.....................................  .............  ............  ...........  .............       65,117
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\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