[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]


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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.

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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, 
[email protected].

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\
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                                                                           Number of
               Activity                    FDA Form        Number of     responses per   Total annual      Average burden per response      Total hours
                                                          respondents     respondent       responses
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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).
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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.

    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\
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                                                     Number of                    Average burden
            Activity                 Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
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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
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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 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