[Federal Register Volume 83, Number 31 (Wednesday, February 14, 2018)]
[Proposed Rules]
[Pages 6480-6490]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02757]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 514

[Docket No. FDA-2017-N-6381]
RIN 0910-AH51


Postmarketing Safety Reports for Approved New Animal Drugs; 
Electronic Submission Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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[[Page 6481]]

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
proposing to amend its postmarketing safety reporting regulations for 
approved new animal drugs to require that certain adverse drug 
experience and product/manufacturing defect reports be submitted to FDA 
in an electronic format that we can process, review, and archive. This 
action is intended to improve our systems for collecting and analyzing 
postmarketing safety reports. The proposed change would help us to more 
rapidly review postmarketing safety reports, identify emerging safety 
problems, and disseminate safety information in support of our public 
health mission. In addition, the proposed amendments would facilitate 
international harmonization and exchange of safety information.

DATES: Submit either electronic or written comments on the proposed 
rule by April 30, 2018. Submit comments on information collection 
issues under the Paperwork Reduction Act of 1995 by March 16, 2018.

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 April 30, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of April 30, 2018. 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 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-6381 for ``Postmarketing Safety Reports for Approved New 
Animal Drugs; Electronic Submission Requirements.'' Received comments, 
those filed in a timely manner (see ADDRESSES), 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.
    Submit comments on information collection issues under the 
Paperwork Reduction Act of 1995 (PRA) to the Office of Management and 
Budget (OMB) in the following ways:
     Fax to the Office of Information and Regulatory Affairs, 
OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or email to 
[email protected]. All comments should be identified with the 
title, ``Records and Reports Concerning Experience with Approved New 
Animal Drugs.''

FOR FURTHER INFORMATION CONTACT: With regard to the proposed rule: 
Linda Walter-Grimm, Center for Veterinary Medicine (HFV-240), Food and 
Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-
5762, [email protected].
    With regard to the information collection: Domini Bean, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Executive Summary
    A. Purpose of the Proposed Rule
    B. Summary of the Major Provisions of the Proposed Rule
    C. Legal Authority
    D. Costs and Benefits
II. Background
    A. Need for the Regulation
    B. Current Regulatory Framework
III. Legal Authority
IV. Description of the Proposed Rule
    A. Scope
    B. Proposed Provisions
V. Proposed Effective and Compliance Dates
VI. Economic Analysis of Impacts
VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Federalism

I. Executive Summary

A. Purpose of the Proposed Rule

    FDA is issuing this proposed rule to amend our regulations under 
Sec.  514.80 (21 CFR 514.80) to require electronic submission of 
certain postmarketing

[[Page 6482]]

safety reports for approved new animal drugs and to provide a procedure 
for requesting a temporary waiver of the requirement. This action is 
intended to improve our systems for collecting and analyzing 
postmarketing safety reports. The proposed change would help us to more 
rapidly review postmarketing safety reports, identify emerging safety 
problems, and disseminate safety information in support of our public 
health mission. In addition, the proposed amendments would facilitate 
international harmonization and exchange of safety information.

B. Summary of the Major Provisions of the Proposed Rule

    We require applicants to submit to us postmarketing safety reports 
of adverse drug experiences and product/manufacturing defects for 
approved new animal drugs (see Sec.  514.80). An applicant is defined 
as ``a person or entity who owns or holds on behalf of the owner the 
approval for an NADA [new animal drug application] or an ANADA 
[abbreviated new animal drug application], and is responsible for 
compliance with applicable provisions of the act and regulations.'' 
(Sec.  514.3 (21 CFR 514.3)) In addition, nonapplicants, defined in 
Sec.  514.3 as ``any person other than the applicant whose name appears 
on the label and who is engaged in manufacturing, packing, 
distribution, or labeling of the product,'' may elect to submit adverse 
drug experience reports directly to us (Sec.  514.80(b)(3)).
    We propose to require electronic submission for the following 
reports for approved new animal drugs: 3-day alert reports that 
applicants elect to submit directly to FDA's Center for Veterinary 
Medicine (CVM) in addition to the requirement they have to submit these 
reports on paper Form FDA 1932 to the appropriate FDA District Office 
or local FDA resident post; 15-day alert reports and followup reports; 
product/manufacturing defect and adverse drug experience reports 
submitted by nonapplicants who elect to report adverse drug experiences 
directly to CVM in addition to providing these reports to the 
applicant; product/manufacturing defect and adverse drug experience 
reports (including reports of previously not reported adverse drug 
experiences that occur in postapproval studies) required to be 
submitted as part of the periodic drug experience report. We propose to 
replace the current paper submission process with the electronic 
submission requirement and a procedure for requesting a temporary 
waiver of the electronic submission requirement. Finally, we propose to 
clarify where to submit reports not required to be submitted 
electronically. Under the proposed rule, we would continue to require 
3-day alert reports to be submitted to the appropriate FDA District 
Office or local FDA resident post. However, as noted, if in addition to 
the report an applicant submits on paper Form FDA 1932 to the 
appropriate FDA District Office or local FDA resident post, an 
applicant elects to submit a 3-day field alert report directly to CVM, 
the applicant would be required to submit the report to CVM 
electronically.

C. Legal Authority

    Our legal authority to require electronic submission of 
postmarketing safety reports for approved new animal drugs derives from 
sections 201, 301, 501, 502, 512, and 701 of the Federal Food, Drug, 
and Cosmetic Act (the FD&C Act) (21 U.S.C. 321, 331, 351, 352, 360b, 
and 371).

D. Costs and Benefits

    The purpose of this proposed rule is to require electronic 
submission of certain postmarketing safety reports for approved new 
animal drugs. The rule, if finalized, would also provide a procedure 
for requesting a temporary waiver of the electronic reporting 
requirement for ``good cause'' shown, such as a natural disaster. As 
currently proposed, this rule would not change the content of the 
postmarketing safety reports or the frequency of the reporting 
requirements. Currently, most submitters have chosen, voluntarily, to 
use electronic submission for the reports that would be affected by 
this proposed rule. As of 2016, approximately 99.7 percent of 
postmarketing safety reports eligible for electronic submission were 
electronically submitted. Thus, this proposed rule would affect a small 
proportion of these reports.
    The major benefits of this proposed rule, if finalized, would be to 
animal health and the Agency in the form of quicker access to 
postmarketing safety information. The annual cost savings to the Agency 
is estimated at $7,535. The present value of these benefits over 10 
years is $64,272 at a 3 percent discount rate, and $52,920 at a 7 
percent discount rate.
    Total one-time costs to industry would be $61,311 for changing 
standard operating procedures (SOPs) and training employees to 
electronically submit postmarketing safety reports in accordance with 
the new SOPs. Recurring costs to the Agency would be $153 per year, for 
processing the waivers to the electronic reporting requirement. 
Annualizing these costs over a 10-year period, we estimate total 
annualized costs to be $7,131 at a 3 percent discount rate, and $8,310 
at a 7 percent discount rate. The present value of these costs over 10 
years is $60,823 at a 3 percent discount rate, and $58,368 at a 7 
percent discount rate.

II. Background

    When a new animal drug is approved and enters the market, the 
product is introduced to a larger population in settings different from 
the controlled studies required by the approval process. New 
information generated during the postmarketing period offers further 
insight into the benefits and/or risks of the product, and evaluation 
of this information is important to ensure the safe and effective use 
of these products.

A. Need for the Regulation

    CVM receives information regarding adverse drug experiences for 
approved new animal drugs from postmarketing safety reports. For over 
25 years, we have received these safety reports on paper. However, the 
majority of submitters have chosen, voluntarily, to utilize electronic 
submission as electronic means became available. As of 2016, 
approximately 99.7 percent of postmarketing safety reports eligible for 
electronic submission were electronically submitted. The proposed rule 
would require electronic submission of the remaining 0.3 percent of 
postmarketing safety reports eligible for electronic submission.
    Electronic submission improves our ability to process and archive 
postmarketing safety reports in a timely manner, and to make 
postmarketing reports more readily available for analysis. Information 
from electronic and paper reports is entered into our computerized 
database, which is designed to support our postmarketing safety 
surveillance program for animal drug products. Scientists at CVM use 
the database to make decisions about product safety, which may include 
regulatory action. Electronically submitted reports are available for 
analysis as soon as they have been processed, generally within 2 days 
of receipt. Safety reports submitted to us on paper must be physically 
received, reviewed, and then manually entered into our computerized 
database, a process that can take several weeks. Paper reports increase 
the time it takes us to review safety information, impede our ability 
to analyze the data comprehensively, and hinder our ability to quickly 
identify problems. Voluntary electronic submission of safety reports 
has been an important step in improving

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our postmarketing surveillance capabilities.
    The proposed rule, which would require electronic submission of 
certain postmarketing safety reports, would further improve our systems 
for collecting and analyzing these reports and would save FDA an 
expected $7,459 annually, primarily in the cost of processing paper 
submissions. The proposal would:
     Expedite our access to safety information and provide us 
data in a format that would support more efficient and comprehensive 
reviews;
     Enhance our ability to rapidly communicate information 
about suspected problems to animal owners, veterinarians, consumers, 
and industry within the United States and internationally in support of 
our public health mission; and
     Eliminate or reduce the time and costs to industry 
associated with submitting paper reports, and the time, costs, errors, 
and physical storage needs of the Agency associated with manually 
entering data from paper reports into the electronic system for review 
and analysis.
    The proposed rule would allow us to be more responsive to rapidly 
occurring changes in the technological environment. Consistent with our 
current practice for voluntarily provided electronic submissions, the 
proposed rule would require that data in electronic submissions conform 
to the data elements in Form FDA 1932 and our technical documents on 
how to provide electronic submissions (e.g., method of transmission and 
processing, media, file formats, preparation and organization of 
files). The proposed rule would allow us to issue updated technical 
documents, as necessary. The most current information on submitting 
postmarketing safety reports to us in electronic format can be found on 
our web page at http://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm212682.htm (see, e.g., ``Instructions for Electronic 
Submission of Mandatory Adverse Event Reports to FDA CVM''). As 
necessary, we will revise the technical specifications referenced in 
our technical documents to address changing technical specifications or 
any additional specifications needed for electronic submission. Using 
guidance documents and technical documents to communicate these 
technical specifications will permit us to be more responsive to 
rapidly occurring changes in the technological environment.
    The proposed rule is also an important step in our continuing 
efforts to harmonize our postmarketing safety reporting regulations 
with international standards for submitting safety information. 
Currently, the technical specifications referenced in our guidance 
documents supporting the voluntary electronic submission processes rely 
upon and adopt certain safety reporting and transmission standards 
recommended by the International Cooperation on Harmonisation of 
Technical Requirements for Registration of Veterinary Medicinal 
Products (VICH). VICH was formed to facilitate the harmonization of 
technical requirements for the marketing authorization or 
``registration'' of veterinary medicinal products among three regions: 
The European Union, Japan, and the United States. Our electronic 
submission specifications allow applicants or nonapplicants to submit 
postmarketing safety reports using the Health Level 7 (HL7) Individual 
Case Safety Report (ICSR) standard that has been adopted worldwide by 
VICH. In this proposed rule, we reaffirm our intention to continue to 
rely on these VICH-recommended standards. We believe the continued use 
of VICH standards will promote harmonization of safety reporting among 
regulatory agencies and facilitate the international exchange of 
postmarketing safety information. Accordingly, this proposed rule is 
consistent with our ongoing initiatives to encourage the widest 
possible use of electronic submission and to promote international 
harmonization of safety reporting for animal drug products through 
reliance on VICH standards. We anticipate that the proposed rule would 
enhance industry's global pharmacovigilance practices by allowing it to 
use common data elements and transmission standards when submitting 
ICSRs to multiple regulators.

B. Current Regulatory Framework

    The current postmarketing safety reports required under Sec.  
514.80 for approved NADAs and approved ANADAs are summarized below. The 
proposed electronic submission requirement would leave the substantive 
aspects of these reports largely unchanged.
1. Description and Timing of Safety Reports
    Under section 512(l) of the FD&C Act, we may require holders of 
approved NADAs to submit reports regarding postapproval experiences 
with their animal drugs. Our implementing regulation at Sec.  514.80 
requires applicants to submit to us postmarketing safety reports of 
adverse drug experiences and product/manufacturing defects. As stated 
previously, an applicant is defined as ``a person or entity who owns or 
holds on behalf of the owner the approval for an NADA or an ANADA, and 
is responsible for compliance with applicable provisions of the act and 
regulations.'' (See Sec.  514.3.) In addition, nonapplicants, defined 
in Sec.  514.3 as ``any person other than the applicant whose name 
appears on the label and who is engaged in manufacturing, packing, 
distribution, or labeling of the product,'' may elect to submit adverse 
drug experience reports directly to us (Sec.  514.80(b)(3)).
    Specifically, Sec.  514.80(b) requires the following adverse drug 
experience reports, among other reports:
     Three-day field alert reports (Sec.  514.80(b)(1)). 
Applicants must submit a report to the appropriate FDA District Office 
or local resident post with information pertaining to product and 
manufacturing defects that may result in serious adverse drug events 
within 3 working days of first becoming aware that a defect may exist.
     Fifteen-day alert reports (Sec.  514.80(b)(2)(i)) and 
followup reports (Sec.  514.80(b)(2)(ii)). Applicants must submit a 
report to us for each postmarketing adverse drug event that is both 
serious and unexpected within 15 working days of first receiving the 
information about the adverse drug event. A followup report must be 
submitted within 15 working days of receipt of significant new 
information or as requested by us.
     Nonapplicant reports (Sec.  514.80(b)(3)). Nonapplicants 
are required to forward reports of adverse drug experiences to the 
applicant within 3 working days of first receiving the information. A 
nonapplicant may choose to also submit an additional report directly to 
us within 15 working days of first receiving the information, but must 
still provide the report to the applicant. (As noted above, a 
``nonapplicant'' is any person other than the applicant whose name 
appears on the label of the approved new animal drug product and who is 
engaged in the manufacturing, packing, distribution, or labeling of 
that drug product. 21 CFR 514.3.)
     Reports of product/manufacturing defects and adverse drug 
experiences submitted as part of the periodic drug experience report 
(Sec.  514.80(b)(4)(iv)(A) and (C)). Applicants are required to submit 
a periodic report every 6 months for the first 2 years following 
approval (6-month periodic drug experience reports) and yearly 
thereafter (yearly

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periodic drug experience report). The periodic drug experience report 
must contain, among other things, reports for each product/
manufacturing defect and adverse drug experience not previously 
reported as 3-day field alert reports under Sec.  514.80(b)(1) or 15-
day alert or followup reports under Sec.  514.80 (b)(2) (i.e., the 
periodic drug experience report must contain reports of all expected or 
nonserious adverse drug events and product/manufacturing defects that 
did not result in an adverse drug event report). This also includes 
previously not reported adverse drug experiences that occur in 
postapproval studies.
2. Current Methods for the Submission of Postmarketing Safety Reports
    As noted, for over 25 years we have received postmarketing safety 
reports on paper. Currently, Sec.  514.80 requires that applicants and 
nonapplicants submit to us reports of adverse drug experiences and 
product/manufacturing defects on paper Form FDA 1932. It further 
requires that 3-day field alert reports must be submitted to the 
appropriate FDA District Field Office or local FDA resident post while 
15-day alert reports and followup reports, periodic drug experience 
reports, and nonapplicant reports must be submitted to CVM (Sec.  
514.80(b)(1) to (3), (b)(4)(iv)(A) and (C), and (g)).
    As noted earlier in this preamble, since May 2010 we have provided 
industry with the option of submitting certain postmarketing safety 
reports electronically. Since that time, the majority of submitters 
have chosen, voluntarily, to utilize electronic submission. As of 2016, 
approximately 99.7 percent of postmarketing safety reports eligible for 
electronic submission were electronically submitted.
    Reports that may be submitted electronically include 15-day alert 
reports and followup reports (Sec.  514.80(b)(2)(i) and (ii)); 
nonapplicant reports of adverse drug experiences submitted directly to 
FDA (Sec.  514.80(b)(3)); and reports of product/manufacturing defects 
and adverse drug experiences submitted as part of the periodic drug 
experience report (Sec.  514.80(b)(4)(iv)(A) and (C)). At this time, 3-
day field alert reports (Sec.  514.80(b)(1)) must be submitted on paper 
Form FDA 1932 to the appropriate FDA District Office or local resident 
post. CVM collaborates with the FDA District Office or local resident 
post to follow up as appropriate in response to 3-day field alert 
reports. If an applicant elects to submit a 3-day field alert report 
directly to CVM, the applicant would be required to submit the report 
electronically. However, this would not alleviate the applicant's 
responsibility to submit this report to the FDA District Field Office 
or local FDA resident post on paper Form FDA 1932.
    Electronic reports may be submitted through FDA's Electronic 
Submission Gateway or through the FDA-National Institutes of Health 
Safety Reporting Portal (Safety Reporting Portal). The Electronic 
Submission Gateway allows applicants or nonapplicants to submit 
postmarketing safety reports using the HL7 ICSR standard, which, as 
discussed earlier in this preamble, has been adopted worldwide by VICH. 
The Electronic Submission Gateway provides industry with gateway-to-
gateway access to transmit an HL7 ICSR message using the FDA electronic 
submission standard. The Safety Reporting Portal provides applicants or 
nonapplicants a means to submit individual postmarketing safety reports 
without having to make financial investments in the technical 
infrastructure needed to access the Electronic Submission Gateway. Any 
person who has internet access can use the Safety Reporting Portal to 
submit reports through a user-friendly, interactive questionnaire 
available at https://www.safetyreporting.hhs.gov/.
    For applicants or nonapplicants that submit large numbers of 
reports, sending an HL7 ICSR electronic file is more cost effective 
because the information from the reports is transmitted directly from 
the submitter's database to FDA, eliminating the need for additional 
resources for collating, copying, storing, retrieving, and mailing 
paper copies. For applicants or nonapplicants that submit a small 
number of reports, the use of the web-based Safety Reporting Portal may 
be more cost effective than implementing a system to send an HL7 ICSR 
message through the FDA Electronic Submission Gateway.

III. Legal Authority

    Section 512(l) of the FD&C Act requires that, following approval of 
a NADA or ANADA, applicants must establish and maintain records and 
make reports to the Agency of data related to experience, as prescribed 
by regulation or order. FDA has general rulemaking authority under 
section 701(a) of the FD&C Act, which permits the Secretary of Health 
and Human Services to promulgate regulations for the efficient 
enforcement of the FD&C Act. In order to implement section 512(l) of 
the FD&C Act, FDA promulgated regulations for records and updates 
concerning experience with new animal drugs (see Sec.  514.80). The 
proposed amendments to this regulation will further efficient 
enforcement of section 512(l) by permitting records and reports to be 
reported electronically.

IV. Description of the Proposed Rule

    We are proposing to amend our regulations in part 514 (21 CFR part 
514). The proposed rule would require electronic submission of certain 
postmarketing safety reports for approved new animal drugs and provide 
a procedure for requesting a temporary waiver of the requirement. This 
action is intended to improve our systems for collecting and analyzing 
postmarketing safety reports.

A. Scope

    The proposed rule would amend Sec.  514.80 to require electronic 
submission of the following postmarketing safety reports for approved 
new animal drugs:
     Three-day alert reports that applicants elect to submit 
directly to CVM in addition to the requirement they have to submit 
these reports on paper Form FDA 1932 to the appropriate FDA District 
Office or local FDA resident post (Sec.  514.80(b)(1);
     Fifteen-day alert reports (Sec.  514.80(b)(2)(i)) and 
followup reports (Sec.  514.80(b)(2)(ii));
     Product/manufacturing defects and adverse drug experience 
reports submitted by nonapplicants who elect to report adverse drug 
experiences directly to FDA under Sec.  514.80(b)(3) in addition to 
providing these reports to the applicant; and
     Product/manufacturing defects and adverse drug experience 
reports (including reports of previously not reported adverse drug 
experiences that occur in postapproval studies) required to be 
submitted as part of the periodic drug experience report (Sec.  
514.80(b)(4)(iv)(A) and (C)).
    At this time, we are not proposing to require electronic submission 
of 3-day field alert reports (Sec.  514.80(b)(1)) to the appropriate 
FDA District Office or local resident post because, as noted 
previously, we currently do not have the information technology systems 
in place to share with FDA District Offices or local resident posts 
reports submitted electronically through the Electronic Submission 
Gateway or Safety Reporting Portal. Under this proposed rule, these 
reports would continue to be submitted on paper Form FDA 1932 directly 
to the appropriate FDA District Office or local resident post. CVM will 
continue to collaborate with the FDA District Office or local resident 
post to follow up as appropriate in response to

[[Page 6485]]

3-day field alert reports submitted directly to the FDA District Office 
or local resident post. However, as noted, if an applicant elects to 
submit a 3-day field alert report directly to CVM, the applicant would 
be required to submit the report electronically. This would not 
alleviate the applicant's responsibility to submit this report to the 
FDA District Field Office or local FDA resident post on paper Form FDA 
1932.

B. Proposed Provisions

1. Electronic Submission Requirement
    We are proposing that applicants would continue to have the 
obligation to submit 3-day field alert reports directly to the 
appropriate FDA District Office or local resident post within 3 working 
days of first becoming aware that a defect may exist. However, if 
applicants choose to also report directly to CVM in addition to 
reporting to the appropriate FDA District Office or local resident 
post, they would be required to submit the report to CVM 
electronically, unless we grant a waiver permitting an alternate 
submission method or we otherwise request an alternate submission 
method. (See proposed Sec.  514.80(b)(1).)
    We are proposing that 15-day alert reports and followup reports 
would be required to be submitted to us electronically, unless we grant 
a waiver permitting an alternate submission method (see section IV.B.2 
of this document) or we otherwise request an alternate submission 
method (see section IV.B.3 of this document). (See proposed Sec.  
514.80(b)(2)(i) and (ii).)
    We are proposing that nonapplicants would continue to have the 
obligation of forwarding reports of adverse drug experiences to the 
applicant within 3 working days of first receiving the information. 
Nonapplicants would also continue to have the option of choosing to 
report directly to us in addition to reporting to the applicant. 
However, if nonapplicants opt to report directly to us, they would be 
required to submit the report electronically, unless we grant a waiver 
permitting an alternate submission method or we otherwise request an 
alternate submission method. (See proposed Sec.  514.80(b)(3).)
    We are proposing that reports of product/manufacturing defects and 
adverse drug experiences required to be submitted as part of the 
periodic drug experience report would be required to be submitted to us 
electronically, unless we grant a waiver permitting an alternate 
submission method or we otherwise request an alternate submission 
method. (See proposed Sec.  514.80(b)(4)(iv)(A) and (C).) This includes 
reports of defects and experiences not previously reported under Sec.  
514.80(b)(1) and (2) and previously not reported adverse drug 
experiences that occur in postapproval studies. These reports could be 
submitted individually at any time within the timeframe for submitting 
the periodic drug experience report under current Sec.  514.80(b)(4).
    We are proposing that reports submitted to us under Sec.  
514.80(b)(1), (b)(2)(i) and (ii), (b)(3), and (b)(4)(iv)(A) and (C) be 
submitted in an electronic format that FDA can process, review, and 
archive, and that data submitted in electronic submissions conform to 
the data elements in Form FDA 1932 and our technical documents on how 
to provide electronic submissions (e.g., method of transmission and 
processing, media, file formats, preparation and organization of 
files). The proposed rule would allow us to issue updated technical 
documents, as necessary. (See proposed Sec.  514.80(d)(1).)
2. Waivers
    We are proposing to allow applicants or nonapplicants to request a 
temporary waiver from the electronic submission requirement for ``good 
cause'' shown. Examples of circumstances that could constitute ``good 
cause'' for granting waivers of the electronic submission requirement 
include crisis situations that impact an applicant's or nonapplicant's 
ability to report electronically, such as natural disasters, pandemics, 
and terrorism. The proposed rule would require applicants and 
nonapplicants to submit a waiver request to us in writing. The initial 
request, however, could be made by telephone or email to CVM's Division 
of Veterinary Product Safety, with prompt written followup submitted as 
a letter to the application. If we grant the request for a temporary 
waiver, the applicant or nonapplicant would be required to follow the 
conditions for reporting that we specify upon granting the waiver. (See 
proposed Sec.  514.80(d)(2).)
    We anticipate that temporary waivers of the electronic submission 
requirement will only be needed in rare circumstances such as natural 
disasters, pandemics, and terrorism, as noted. An applicant or 
nonapplicant experiencing technical difficulties that temporarily 
prevent use of the Electronic Submission Gateway could, as a backup, 
electronically submit reports using the Safety Reporting Portal. An 
applicant or nonapplicant that relies on the Safety Reporting Portal 
but experiences a short-term, temporary interruption of internet 
services could, as a backup, electronically submit reports from any 
other computer with access to a working internet connection.
3. FDA Request for Alternate Submission Method
    We may require an applicant or nonapplicant to submit reports that 
would otherwise be required to be submitted electronically to be 
submitted in an alternate format, such as on paper using Form FDA 1932. 
We anticipate that we would request the submission of reports through 
an alternate method only in the event that we experience a prolonged 
system outage or other major technical problem. During such an event, 
we would provide advice on the desired method for submission (most 
likely on paper using Form FDA 1932) and the types of reports that 
should be submitted using the alternate method. Applicants and 
nonapplicants should be prepared to comply with such a request by 
maintaining the capability to submit paper reports using Form FDA 1932 
if needed. (See proposed Sec.  514.80(b)(1) to (3), and (b)(4)(iv)(A) 
and (C).)
4. Mailing Addresses
    Finally, we propose to clarify where to submit reports not required 
to be submitted electronically. Under the proposed rule, we would 
continue to require 3-day alert reports to be submitted to the 
appropriate FDA District Office or local FDA resident post. (See 
proposed Sec.  514.80(g).)

V. Proposed Effective and Compliance Dates

    We propose that any final rule based on this proposal become 
effective 30 days after the date on which it is published in the 
Federal Register. Although we are proposing that the final rule become 
effective 30 days after the date of publication in the Federal 
Register, we are proposing to provide additional time before applicants 
and nonapplicants would be required to comply with the electronic 
submission requirement. We propose that the compliance date would be 12 
months after the publication date of the final regulation. The Safety 
Reporting Portal currently is capable of receiving all of the affected 
reports and is available to any applicant or nonapplicant with access 
to the internet. We tentatively conclude that applicants and 
nonapplicants not currently submitting the affected reports 
electronically would, in 12 months, be able to make changes to their 
business practices that would be needed to come into compliance with 
the proposed requirements.

[[Page 6486]]

VI. Economic Analysis of Impacts

    We have examined the impacts of the proposed rule under Executive 
Order 12866, Executive Order 13563, Executive Order 13771, the 
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded 
Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 
13563 direct us to assess all costs and benefits of available 
regulatory alternatives and, when regulation is necessary, to select 
regulatory approaches that maximize net benefits (including potential 
economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). Executive Order 13771 
requires that the costs associated with significant new regulations 
``shall, to the extent permitted by law, be offset by the elimination 
of existing costs associated with at least two prior regulations.'' We 
believe that this proposed rule is not a significant regulatory action 
as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because the costs of the rule are minimal in both absolute 
value and in comparison to average yearly sales of small firms in this 
industry, we propose to certify that the proposed rule will not have a 
significant economic impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $148 million, using the most current (2016) Implicit 
Price Deflator for the Gross Domestic Product. This proposed rule would 
not result in an expenditure in any year that meets or exceeds this 
amount.
    The purpose of this proposed rule is to require electronic 
submission of certain postmarketing safety reports for approved new 
animal drugs. The rule, if finalized, would also provide a procedure 
for requesting a temporary waiver of the electronic reporting 
requirement for ``good cause'' shown, such as a natural disaster. As 
currently proposed, this rule would not change the content of the 
postmarketing safety reports or the frequency of the reporting 
requirements.
    The major benefits of this proposed rule, if finalized, would be to 
animal health and the Agency in the form of quicker access to 
postmarketing safety information; the annual cost savings to the Agency 
is estimated at $7,535. The present value of these benefits over 10 
years is $64,272 at a 3 percent discount rate, and $52,920 at a 7 
percent discount rate.
    Total one-time costs to industry would be $61,311 for changing SOPs 
and training employees to electronically submit postmarketing safety 
reports in accordance with the new SOPs. Recurring costs to the Agency 
would be $153 per year, for processing the waivers to the electronic 
reporting requirement. Annualizing these costs over a 10-year period, 
we estimate total annualized costs to be $7,131 at a 3 percent discount 
rate, and $8,310 at a 7 percent discount rate. The present value of 
these costs over 10 years is $60,823 at a 3 percent discount rate, and 
$58,368 at a 7 percent discount rate.

                                       Summary of Benefits, Costs, and Distributional Effects of the Proposed Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                      Units
                                                                                                     ---------------------------------------
                           Category                              Primary        Low          High                                  Period       Notes
                                                                 estimate     estimate     estimate       Year       Discount     covered
                                                                                                        dollars      rate (%)     (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized...............................................       $7,535  ...........  ...........         2016            7           10  ...........
    Monetized $/year.........................................        7,535  ...........  ...........         2016            3           10  ...........
    Annualized...............................................  ...........  ...........  ...........  ...........            7  ...........  ...........
    Quantified...............................................  ...........  ...........  ...........  ...........            3  ...........  ...........
    Qualitative..............................................  ...........  ...........  ...........  ...........  ...........  ...........  ...........
Costs:
    Annualized...............................................        7,131  ...........  ...........         2016            7           10  ...........
    Monetized $/year.........................................        8,310  ...........  ...........         2016            3           10
    Annualized...............................................  ...........  ...........  ...........  ...........            7  ...........  ...........
    Quantified...............................................  ...........  ...........  ...........  ...........            3  ...........  ...........
    Qualitative..............................................  ...........  ...........  ...........  ...........  ...........  ...........  ...........
Transfers:
    Federal..................................................  ...........  ...........  ...........  ...........            7  ...........  ...........
    Annualized Monetized $millions/year......................  ...........  ...........  ...........  ...........            3  ...........  ...........
--------------------------------------------------------------------------------------------------------------------------------------------------------
                           From/To                                             From:
                                                                                To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Other Annualized.............................................  ...........  ...........  ...........  ...........            7  ...........  ...........
Monetized $millions/year.....................................  ...........  ...........  ...........  ...........            3  ...........  ...........
--------------------------------------------------------------------------------------------------------------------------------------------------------
                           From/To                                             From:
                                                                                To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government:..................................................................................................................
        Small Business: Will not have a significant impact on a substantial number of small entities....................................................
    Wages:..............................................................................................................................................
    Growth:.............................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 6487]]

We have developed a comprehensive Economic Analysis of Impacts that 
assesses the impacts of the proposed rule. The full analysis of 
economic impacts is available in the docket (FDA-2017-N-6381) for this 
proposed rule and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

VII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VIII. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that 
are subject to review by OMB under the PRA (44 U.S.C. 3501-3520). A 
description of these provisions is given in the Description section of 
this document with an estimate of the one-time and recurring reporting 
burdens. Included in the estimate is the time for reviewing 
instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing each 
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.
    Title: Records and Reports Concerning Experience with Approved New 
Animal Drugs--OMB Control Number 0910-0284--Revision
    Description: This proposed rule would revise the existing 
information collection requirements in the postmarketing safety 
reporting regulations for approved new animal drugs to require 
electronic submission of certain postmarketing safety reports for 
approved new animal drugs. This rule does not change the content of 
these postmarketing reports. It only proposes to require that they be 
submitted in an electronic form. We are also proposing to provide a 
procedure for requesting a temporary waiver of the requirement.
    Description of Respondents: Respondents to the information 
collection provisions of this proposed rule are applicants and 
nonapplicants.
    Reporting: Currently, the postmarketing safety reporting 
regulations for approved new animal drugs include requirements to 
submit to us postmarketing safety reports of adverse drug experiences 
and product/manufacturing defects. Section 514.80 requires applicants 
and nonapplicants 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 or nonapplicants are required to submit adverse event 
reports and product/manufacturing defect reports under Sec.  
514.80(b)(1) to (3) and (b)(4)(iv)(A) and (C) on Form FDA 1932. Form 
FDA 1932 may be submitted on paper or electronically via the Electronic 
Submission Gateway or Safety Reporting Portal. Form FDA 1932a (the 
voluntary reporting form) is used by veterinarians and the public to 
submit adverse event reports, product defects, and lack of 
effectiveness complaints directly to FDA. Form FDA 1932a may be 
submitted on paper or may be submitted electronically by completing and 
emailing a fillable PDF form. Form FDA 2301 is used 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)). Form FDA 2301 may be submitted on 
paper, may be submitted electronically by completing and emailing a 
fillable PDF form, or may be submitted electronically via CVM's 
eSubmitter. 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.
    The proposed rule will revise these requirements to require 
electronic submission of the following postmarketing safety reports for 
approved new animal drugs:
     Three-day alert reports that applicants elect to submit 
directly to CVM in addition to the requirement that they have to submit 
these reports on paper Form FDA 1932 to the appropriate FDA District 
Office or local FDA resident post (Sec.  514.80(b)(1);
     Fifteen-day alert reports (Sec.  514.80(b)(2)(i)) and 
followup reports (Sec.  514.80(b)(2)(ii));
     Product/manufacturing defects and adverse drug experience 
reports submitted by nonapplicants who elect to report adverse drug 
experiences directly to FDA under Sec.  514.80(b)(3) in addition to 
providing these reports to the applicant; and
     Product/manufacturing defects and adverse drug experience 
reports (including reports of previously not reported adverse drug 
experiences that occur in postapproval studies) required to be 
submitted as part of the periodic drug experience report (Sec.  
514.80(b)(4)(iv)(A) and (C)).
    At this time, we are not proposing to require electronic submission 
of 3-day field alert reports (Sec.  514.80(b)(1)) to the appropriate 
FDA District Office or local resident post because, as noted 
previously, we currently do not have the information technology systems 
in place to share with the FDA District Office or local resident post 
reports submitted electronically through the Electronic Submission 
Gateway or Safety Reporting Portal. These reports would continue to be 
submitted on paper Form FDA 1932 directly to the appropriate FDA 
District Office or local resident post. CVM will continue to 
collaborate with the FDA District Office or local resident post to 
follow up as appropriate in response to 3-day field alert reports 
submitted directly to the FDA District Office or local resident post. 
However, as noted, if an applicant elects to submit a 3-day field alert 
report directly to CVM, the applicant would be required to submit the 
report electronically. This would not alleviate the applicant's 
responsibility to submit this report to the FDA District Field Office 
or local FDA resident post on paper Form FDA 1932.
    The proposed rule will also revise these requirements to allow 
applicants or nonapplicants to request a temporary waiver from the 
electronic submission requirement for ``good cause'' shown. Examples of 
circumstances that could constitute ``good cause'' for granting waivers 
of the electronic submission requirement include crisis situations that 
impact an applicant's or nonapplicant's ability to report 
electronically, such as natural disasters, pandemics, and terrorism. 
The proposed rule would require applicants and nonapplicants to submit 
a waiver request to us in writing. The initial request, however, could 
be made by telephone or email to CVM's Division of Veterinary Product 
Safety, with prompt

[[Page 6488]]

written followup submitted as a letter to the application.
    The continuous monitoring of new animal drugs affords the primary 
means by which we obtain information regarding problems with the safety 
and efficacy of marketed approved new animal drugs, as well as product/
manufacturing problems. Postapproval marketing surveillance is 
important to ensure the continued safety and effectiveness of new 
animal drugs. Drug effects can change over time and other effects may 
not manifest until years after the approval.
    We estimate the reporting burden of this collection of information 
as follows:

                                                    Table 1--Estimated Recurring Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                             Number of
                     21 CFR section                        Form FDA No.      Number of     responses per   Total annual   Average burden    Total hours
                                                                            respondents     respondent       responses     per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Electronic submission of postmarketing safety reports               1932              15              18             270               1             270
 under proposed Sec.   514.80(b)(1), (b)(2)(i) and (ii),
 (b)(3), and (b)(4)(iv)(A) and (C)......................
Request for waiver, proposed Sec.   514.80(d)(2)........             N/A               1               1               1               1               1
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............             271  ..............             271
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Table 1 shows the estimated recurring reporting burden associated 
with the proposed rule. In section II.C. of the Preliminary Regulatory 
Impact Analysis (PRIA), we estimated that 15 firms submitted a paper 
Form FDA 1932 report from 2011 to 2015 and thus would be affected by 
the proposed rule's requirement to submit electronically. As stated in 
the PRIA, we estimate that in 2016 CVM received 270 of the affected 
postmarketing safety reports on paper. We calculate the number of 
responses per respondent as the total annual responses divided by the 
number of respondents. We estimate that, on average, it will take 1 
hour to submit electronic postmarketing safety reports for approved new 
animal drugs, for a total of 270 hours. We base our estimate of 1 hour 
per report on our experience with electronic postmarketing safety 
reporting. In the PRIA, we also estimated the burdens associated with 
submission of waiver requests. We expect very few waiver requests (see 
section II.E. of the PRIA), estimating that approximately one firm 
would request a waiver annually under proposed Sec.  514.80(d)(2). We 
estimate that a waiver request would take approximately 1 hour to 
prepare and submit to us. Together, this results in a total of 271 
hours and 271 responses. If this rule is finalized as proposed, we 
would reduce the paper reporting collection approved under OMB control 
number 0910-0284 by 270 hours and increase the electronic reporting 
collection approved under OMB control number 0910-0645 by 270 hours.
    Recordkeeping: We estimate the recordkeeping burden of this 
collection of information as follows:

                                                  Table 2--Estimated One-Time Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of                       Average burden
                              Activity                                  Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Write New SOPs.....................................................               15                1               15               20              300
Training...........................................................               15                1               15               20              300
                                                                    ------------------------------------------------------------------------------------
    Total..........................................................  ...............  ...............               30  ...............              600
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Table 2 shows the estimated one-time recordkeeping burden 
associated with the proposed rule. This burden includes both the one-
time burden of creating new SOPs to submit the reports electronically 
and the one-time cost of training employees to electronically submit 
postmarketing safety reports to CVM in accordance with the new SOPs. In 
section II.E. of the PRIA, we estimated that approximately 15 firms 
would be affected by this proposed rule, if finalized. We also 
estimated that it would take approximately 20 hours per firm to create 
new SOPs for electronic submission of postmarketing safety reports and 
approximately 20 hours per firm to complete the training of employees 
to electronically submit postmarketing safety reports in accordance 
with the new SOPs. Together, this results in a total of 600 hours and 
30 records. We assume that there are no capital costs associated with 
firms implementing this proposed rule (i.e., applicants and 
nonapplicants in the pharmaceutical industry already have the computer 
and internet capacity necessary to electronically submit postmarketing 
safety reports).
    To ensure that comments on information collection are received, OMB 
recommends that written comments be faxed to the Office of Information 
and Regulatory Affairs, OMB (see ADDRESSES). All comments should be 
identified with the title of the information collection.
    In compliance with the PRA (44 U.S.C. 3407(d)), the Agency has 
submitted the information collection provisions of this proposed rule 
to OMB for review. These requirements will not be effective until FDA 
obtains OMB approval. FDA will publish a notice concerning OMB approval 
of these requirements in the Federal Register.

IX. Federalism

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. We have determined that 
this proposed rule does not contain policies that have

[[Page 6489]]

substantial direct effects on the States, on the relationship between 
the National Government and the States, or on the distribution of power 
and responsibilities among the various levels of government. 
Accordingly, we conclude that the rule does not contain policies that 
have federalism implications as defined in the Executive Order and, 
consequently, a federalism summary impact statement is not required.

List of Subjects in 21 CFR Part 514

    Administrative practice and procedure, Animal drugs, Confidential 
business information, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, we propose 
that 21 CFR part 514 be amended as follows:

PART 514--NEW ANIMAL DRUG APPLICATIONS

0
1. The authority citation for part 514 continues to read as follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 354, 356a, 360b, 
360ccc, 371, 379e, 381.

0
2. Section 514.80 is amended as follows:
0
a. Revise the entries in the table for paragraphs (b)(4), (d), (e), and 
(g);
0
b. Add a fifth sentence to paragraph (b)(1); and
0
c. Revise the last sentence of paragraph (b)(2)(i); the third sentence 
of paragraph (b)(2)(ii); the last sentence of paragraph (b)(3); 
paragraphs (b)(4)(iv)(A) and (C); paragraph (b)(4)(v); and paragraphs 
(d) and (g).
    The addition and revisions read as follows:


Sec.  514.80  Records and reports concerning experience with approved 
new animal drugs.

* * * * *

 
----------------------------------------------------------------------------------------------------------------
                                  Purpose                                         21 CFR paragraph and title
----------------------------------------------------------------------------------------------------------------
 
                                                   * * * * * *
What are the general requirements for submission of periodic drug            514.80(b)(4) Periodic drug
 experience reports, e.g., method of submission, submission date and          experience report.
 frequency, when is it to be submitted, how many copies?
How do I petition to change the date of submission or frequency of
 submissions?
 
                                                   * * * * * *
What reports must be submitted to FDA electronically?......................  514.80(d) Format for Submissions.
How can I apply for a waiver from the electronic reporting requirements?
How do I obtain Form FDA 1932 and Form FDA 2301?
How long must I maintain records and reports required by this section?.....  514.80(e) Records to be maintained.
 
                                                   * * * * * *
Where do I mail reports that are not required to be submitted                514.80(g) Mailing addresses.
 electronically?.
 
                                                   * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
    (b) * * *
    (1) * * * If the applicant elects to also report directly to the 
FDA's Center for Veterinary Medicine (CVM), the applicant must submit 
the report to CVM in electronic format as described in paragraph (d)(1) 
of this section, unless the applicant obtains a waiver under paragraph 
(d)(2) of this section or FDA requests the report in an alternate 
format.
    (2) * * *
    (i) * * * The report must be submitted to FDA in electronic format 
as described in paragraph (d)(1) of this section, unless the applicant 
obtains a waiver under paragraph (d)(2) of this section or FDA requests 
the report in an alternate format.
    (ii) * * * A followup report must be submitted to FDA in electronic 
format as described in paragraph (d)(1) of this section, unless the 
applicant obtains a waiver under paragraph (d)(2) of this section or 
FDA requests the report in an alternate format. * * *
    (3) * * * If the nonapplicant elects to also report directly to 
FDA, the nonapplicant must submit the report to FDA in electronic 
format as described in paragraph (d)(1) of this section, unless the 
nonapplicant obtains a waiver under paragraph (d)(2) of this section or 
FDA requests the report in an alternate format.
    (4) * * *
    (iv) * * *
    (A) Product/manufacturing defects and adverse drug experiences not 
previously reported under Sec.  514.80(b)(1) and (b)(2) must be 
reported individually to FDA in electronic format as described in 
paragraph (d)(1) of this section, unless the applicant obtains a waiver 
under paragraph (d)(2) of this section or FDA requests the report in an 
alternate format.
    (B) * * *
    (C) Reports of previously not reported adverse drug experiences 
that occur in postapproval studies must be reported individually to FDA 
in electronic format as described in paragraph (d)(1) of this section, 
unless the applicant obtains a waiver under paragraph (d)(2) of this 
section or FDA requests the report in an alternate format.
    (v) * * * The summaries must state the time period on which the 
increased frequency is based, time period comparisons in determining 
increased frequency, references to any reports previously submitted 
under paragraphs (b)(1), (b)(2), (b)(3), and (b)(4)(iv)(A) and (C) of 
this section, the method of analysis, and the interpretation of the 
results. The summaries must be submitted in a separate section within 
the periodic drug experience report.
* * * * *
    (d) Format for submissions.--(1) Electronic submissions. Except as 
provided in paragraph (d)(2), reports submitted to FDA under paragraphs 
(b)(2)(i) and (ii), (b)(3), and (b)(4)(iv)(A) and (C) of this section 
and reports submitted to CVM under paragraph (b)(1) of this section 
must be submitted in an electronic format that FDA can process, review, 
and archive. Data provided in electronic submissions must be in 
conformance with the data elements in Form FDA 1932 and FDA technical 
documents describing transmission. As necessary, FDA will issue updated 
technical documents on

[[Page 6490]]

how to provide the electronic submission (e.g., method of transmission 
and processing, media, file formats, preparation, and organization of 
files). Unless requested by FDA, paper copies of reports submitted 
electronically should not be submitted to FDA.
    (2) Waivers. An applicant or nonapplicant may request, in writing, 
a temporary waiver of the electronic submission requirements in 
paragraph (d)(1) of this section. The initial request may be by 
telephone or email to CVM's Division of Veterinary Product Safety, with 
prompt written followup submitted as a letter to the application(s). 
FDA will grant waivers on a limited basis for good cause shown. If FDA 
grants a waiver, the applicant or nonapplicant must comply with the 
conditions for reporting specified by FDA upon granting the waiver.
    (3) Paper forms. If approved by FDA before use, a computer-
generated equivalent of Form FDA 1932 may be used for reports submitted 
to the appropriate FDA District Office or local FDA resident post under 
paragraph (b)(1) and to FDA under (d)(2), and a computer-generated 
equivalent of Form FDA 2301 may be used for reports submitted to FDA 
under paragraph (b)(4). Form FDA 1932 may be obtained on the FDA 
website, by telephoning CVM's Division of Veterinary Product Safety, or 
by submitting a written request to the following address: Food and Drug 
Administration, Center for Veterinary Medicine, Division of Veterinary 
Product Safety (HFV-240), 7500 Standish Pl., Rockville, MD 20855-2764. 
Form FDA 2301 may be obtained on the FDA website, by telephoning CVM's 
Division of Surveillance (HFV-210), or by submitting a written request 
to the following address: Food and Drug Administration, Center for 
Veterinary Medicine, Division of Surveillance (HFV-210), 7500 Standish 
Pl., Rockville, MD 20855-2764.
* * * * *
    (g) Mailing addresses. Three-day alert reports must be submitted to 
the appropriate FDA District Office or local FDA resident post. 
Addresses for District Offices and resident posts may be obtained on 
the FDA website. Other reports not required to be submitted to FDA in 
electronic format must be submitted to the following address: Food and 
Drug Administration, Center for Veterinary Medicine, Document Control 
Unit (HFV-199), 7500 Standish Pl., Rockville, MD 20855-2764.
* * * * *

    Dated: February 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02757 Filed 2-13-18; 8:45 am]
 BILLING CODE 4164-01-P


