[Federal Register Volume 85, Number 146 (Wednesday, July 29, 2020)]
[Rules and Regulations]
[Pages 45505-45513]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15441]



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  Federal Register / Vol. 85, No. 146 / Wednesday, July 29, 2020 / 
Rules and Regulations  

[[Page 45505]]



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, Health and Human Services (HHS).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
issuing a final rule to require electronic submission of certain 
postmarketing safety reports for approved new animal drugs. The final 
rule also provides a procedure for requesting a temporary waiver of the 
electronic submission requirement.

DATES: This rule is effective August 28, 2020. For the applicable 
compliance date, please see section V, ``Effective and Compliance 
Dates'' in SUPPLEMENTARY INFORMATION.

ADDRESSES: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov and insert the 
docket number found in brackets in the heading of this final rule 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: With regard to the final rule: Linda 
Walter-Grimm, Center for Veterinary Medicine (HFV-240), Food and Drug 
Administration, 7519 Standish Pl., MPN4, Rm. 2666, Rockville, MD 20855, 
240-402-5762, Linda.Walter-Grimm@fda.hhs.gov.
    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, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Executive Summary
    A. Purpose of the Final Rule
    B. Summary of the Major Provisions of the Final Rule
    C. Legal Authority
    D. Costs and Benefits
II. Background
    A. Need for the Regulation
    B. Summary of Comments to the Proposed Rule
    C. General Overview of the Final Rule
III. Legal Authority
IV. Comments on the Proposed Rule and FDA Response
    A. Introduction
    B. Description of General Comments and FDA Response
    C. Specific Comments and FDA Response
V. Effective and Compliance Dates
VI. Economic Analysis of Impacts
VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Federalism
X. Consultation and Coordination With Indian Tribal Governments
XI. References

I. Executive Summary

A. Purpose of the Final Rule

    The purpose of this rulemaking is to require electronic submission 
of certain postmarketing safety reports for approved new animal drugs 
and to provide a procedure for requesting a temporary waiver of the 
requirement.
    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 (21 CFR 514.80)). An 
applicant is defined as a person or entity who owns or holds on behalf 
of the owner the approval for a new animal drug application (NADA) or 
an abbreviated new animal drug application (ANADA) and is responsible 
for compliance with applicable provisions of the Federal Food, Drug, 
and Cosmetic Act (FD&C Act) and regulations (see Sec.  514.3 (21 CFR 
514.3)). In addition, a nonapplicant, 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)).
    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.
    Finalizing this rule will improve our systems for collecting and 
analyzing postmarketing safety reports. The change will 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 amendments will facilitate 
international harmonization and exchange of safety information. This 
rule also provides a procedure for requesting a temporary waiver of the 
electronic submission requirement.

B. Summary of the Major Provisions of the Final Rule

    The rule amends the records and reports regulation in part 514 (21 
CFR part 514) to include the following:
     Procedures relating to the electronic submission of 
certain postmarketing safety reports for approved new animal drugs; and
     Procedures for requesting a temporary waiver of the 
electronic submission requirement.
    The final rule requires electronic submission for the following 
reports for approved new animal drugs: (1) 3-day alert reports that 
applicants elect to submit as a courtesy copy 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; (2) 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; and (3) product/manufacturing defect and 
adverse drug experience reports (including reports of previously not 
reported adverse drug experiences that occur in postapproval studies) 
required

[[Page 45506]]

to be submitted as part of the periodic drug experience report. We are 
replacing the current paper submission process with the electronic 
submission requirement and a procedure for requesting a temporary 
waiver of the electronic submission requirement. Finally, the final 
rule clarifies where to submit reports not required to be submitted 
electronically. Under the final rule, we continue to require 3-day 
alert reports to be submitted to the appropriate FDA District Office or 
local FDA resident post on paper. 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 
as a ``courtesy copy,'' the applicant will be required to submit the 
``courtesy copy'' of 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 FD&C Act (21 U.S.C. 
321, 331, 351, 352, 360b, and 371).

D. Costs and Benefits

    The quantifiable benefit of this rule is annual cost savings of 
$7,908 from reduced data entry time for CVM. The other benefits of this 
final rule would be to animal health and are not quantifiable. The main 
cost of this rule is a one-time upfront cost to industry of $73,500 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 $161 per year, for 
processing the waivers to the electronic reporting requirement. 
Annualizing these costs over a 15-year time horizon (from 2018 to 
2033), we estimate total annualized costs to be $6,139 at a 3 percent 
discount rate, and total annualized costs of $7,703 at a 7 percent 
discount rate. The annualized net benefit of this rule is -$880 at a 3 
percent discount rate and -$2,444 at a 7 percent discount rate. The 
present value of the net benefits is -$10,504 at a 3 percent discount 
rate and -$22,262 at a 7 percent discount rate over a 15-year time 
horizon.

II. Background

A. Need for the Regulation

    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.
    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.
    In the Federal Register of February 14, 2018 (83 FR 6480), we 
proposed to amend our existing animal drug records and reports 
regulation in part 514 to 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 (83 FR 
6480 at 6484). We set forth the rationale that 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 (83 FR 6480 at 6482).
    Electronic submission of postmarketing safety reports:
     Expedites our access to safety information and provides us 
data in a format that will support more efficient and comprehensive 
reviews;
     Enhances 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
     Eliminates or reduces 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.
    Electronic submission of postmarketing safety reports allows us to 
be more responsive to rapidly occurring changes in the technological 
environment. Consistent with our current practice for voluntarily 
provided electronic submissions, the final rule requires 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 final rule allows 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 https://www.fda.gov/animal-veterinary/report-problem/veterinary-adverse-event-reporting-manufacturers (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 final 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 final 
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 final 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

[[Page 45507]]

on VICH standards. We anticipate that the final rule will enhance 
industry's global pharmacovigilance practices by allowing it to use 
common data elements and transmission standards when submitting ICSRs 
to multiple regulators.

B. Summary of Comments to the Proposed Rule

    We received two comment letters on the proposed rule by the close 
of the comment period, each containing one or more comments on one or 
more issues. We received comments from industry and an individual. Some 
comments support our rulemaking and our ongoing efforts to improve our 
systems for collecting and analyzing postmarketing safety reports. Some 
comments offer suggestions for specific changes for us to consider 
making to the subject regulations.

C. General Overview of the Final Rule

    This final rule amends our animal drug records and reports 
regulation at part 514 to require electronic submission of certain 
postmarketing safety reports for approved new animal drugs. In 
addition, the rule provides a procedure for requesting a temporary 
waiver of the requirement. In this rulemaking, we finalize the 
provisions in the proposed rule.

III. Legal Authority

    Our legal authority for issuing this final rule is provided by 
section 512(l) of the FD&C Act relating to records and reports 
concerning approved new animal drugs and section 701(a) of the FD&C 
Act. Section 512(l) of the FD&C Act requires that, following approval 
of an 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. 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 final rule's 
amendments to this regulation will further efficient enforcement of 
section 512(l) by permitting records and reports to be reported 
electronically.

IV. Comments on the Proposed Rule and FDA Response

A. Introduction

    This section summarizes comments we received in response to the 
proposed rule and our response to those comments. Both commenters 
support our rulemaking and our ongoing efforts to improve our systems 
for collecting and analyzing postmarketing safety reports. Some of the 
comments offer suggestions for additional changes to the subject 
regulations. We considered the comments we received in response to the 
proposed rule in preparing this final rule. After considering these 
comments, we are not making any changes to the codified language that 
was included in the proposed rule.
    In sections IV.B. through IV.C., we describe the comments received 
on the proposed rule and provide our responses. To make it easier to 
identify the comments and our responses, the word ``Comment,'' in 
parentheses, appears before the comment's description, and the word 
``Response,'' in parentheses, appears before our response. We have 
numbered each comment to help distinguish between different comments. 
We have grouped similar comments together under the same number, and, 
in some cases, we have separated different issues discussed in the same 
comment and designated them as distinct comments for purposes of our 
responses. The number assigned to each comment or comment topic is 
purely for organizational purposes and does not signify the comment's 
value or importance or the order in which comments were received.

B. Description of General Comments and FDA Response

    Two comments make general remarks supporting the proposed rule 
without focusing on a particular proposed provision.
    (Comment 1) Comments generally support our efforts to require 
electronic submission of certain postmarketing safety reports for 
approved new animal drugs. One comment recognizes that the requirement 
of electronic submission would greatly benefit the Agency and animal 
health by supporting quicker access to postmarketing safety 
information. Another comment applauds our efforts to improve our 
systems for collecting and analyzing postmarketing safety reports and 
to facilitate international harmonization and exchange of safety 
information.
    (Response 1) We appreciate the general support that the comments 
express. As noted in section II.A., we expect this rule to expedite our 
access to safety information and provide us data in a format that will 
support more efficient and comprehensive reviews. This will 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.

C. Specific Comments and FDA Response

    Several comments make specific remarks regarding particular 
proposed provisions. In this section, we discuss and respond to such 
comments.
    (Comment 2) One comment states that, although in favor of 
electronically reporting 3-day alerts to CVM in addition to reporting 
to the appropriate FDA District Office or local resident post, until 
such time that this can be accomplished via a single mechanism (i.e., 
electronic reporting to both segments of the Agency simultaneously), 
this places an undue burden on industry both in time and resources as 
this would require reporting electronically to CVM while continuing to 
file paper Form FDA 1932 to District Offices or local resident posts.
    (Response 2) We currently require 3-day alert reports to be 
submitted to the appropriate FDA District Office or local FDA resident 
post on paper (see Sec.  514.80(b)(1)). However, if in addition to that 
report an applicant elects to submit a 3-day field alert report 
directly to CVM (i.e., a ``courtesy copy''), we proposed to require the 
applicant to submit that additional copy of the report to CVM 
electronically (see proposed Sec.  514.80(b)(1)). At this time FDA 
District Offices do not have the technology to receive Form FDA 1932 
electronically, so we cannot mandate electronic reporting to FDA 
District Offices at this time. In addition, the FDA District Offices 
and local FDA resident posts use a different database for tracking such 
reports, and do not have direct access to the CVM Adverse Drug Event 
(ADE) database (which receives ADE information in part from Form FDA 
1932). We agree that development of a single mechanism to report 3-day 
alert reports via electronic Form FDA 1932 to both the FDA District 
Office (or local FDA resident post) and CVM is ideal, and we are 
interested in developing this capacity; however, this effort is 
preliminary and investigatory at this time. As there is currently no 
requirement to provide a ``courtesy copy'' of 3-day alert reports to 
CVM, the required electronic submission of such copies would only 
burden those applicants that choose to provide them despite any 
additional time and resources needed to do so. Therefore, in this final 
rule, we are keeping the language of the final rule as proposed at

[[Page 45508]]

Sec.  514.80(b)(1). CVM will continue to collaborate with the FDA 
District Office or local resident post to followup as appropriate in 
response to 3-day field alert reports submitted directly to the FDA 
District Office or local resident post.
    (Comment 3) One comment notes that, since the implementation of 
electronic reporting capability, postmarketing safety reports may be 
submitted to us via Extensible Markup Language (XML), which is designed 
to store and transport data and be both human-readable and machine-
readable. Therefore, there is no official Form FDA 1932 version of 
these reports to provide to an inspector during manufacturing site FDA 
inspections. In addition, the comment continues, inspectors are not 
well versed in reading the XML formats created from electronically 
submitted reports. The comment suggests that we provide training to 
inspectors to help them better understand how to read the XML format 
for case data or that we provide industry with guidance for an 
alternative form that could be generated from the database that 
satisfies the inspectors' needs during site inspections.
    (Response 3) We recognize the comment's concerns with regard to 
utility of the XML format information during inspections. We appreciate 
the commenter's interest in either preparing more easily readable 
versions of electronically submitted reports for inspectors or 
providing training to inspectors in reading the XML format of 
electronically submitted reports. We intend to consider these 
suggestions so that inspectors are better able to access the 
information they need during an inspection. However, the comment did 
not request any changes to the language in proposed Sec.  514.80(b)(1), 
nor do we see a reason to make any changes based on the concerns and 
suggestions included in the comment.
    (Comment 4) One comment notes that, while the proposed rule 
provides a procedure for requesting a temporary waiver of the 
electronic submission requirement for ``good cause'' (i.e., crisis 
situations that impact an applicant's or nonapplicant's ability to 
report electronically, such as natural disasters, pandemics, and 
terrorism), the proposed rule does not change the content, frequency, 
or timeline for submission of the postmarketing safety reports to the 
Agency. The comment suggests that, when the Agency's Electronic 
Submission Gateway or Safety Reporting Portal is down, we should grant 
a temporary waiver of the electronic submission requirement for the 
amount of time the Agency website or portal is down.
    (Response 4) We disagree that the Agency should automatically grant 
a temporary waiver from the electronic submission requirement for the 
amount of time that the Agency's Electronic Submission Gateway or 
Safety Reporting Portal is down. As stated in the proposed rule, 
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 (83 FR 6480 
at 6482). We also stated in the proposed rule that an applicant or 
nonapplicant experiencing technical difficulty that temporarily 
prevents 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 (83 FR 6480 
at 6485). It is highly unlikely that both the Agency's Electronic 
Submission Gateway or Safety Reporting Portal would be down at the same 
time. In the unlikely event that the Agency experiences a prolonged 
system outage or other major technical problem (which would include the 
highly unlikely situation where both the Agency's Electronic Submission 
Gateway or Safety Reporting Portal are down), the Agency does not 
intend to enforce the requirement to submit reports electronically so 
long as an applicant or nonapplicant submits reports in an alternate 
format (most likely on paper using Form FDA 1932).
    We are not waiving the required content, frequency, or timeline for 
submission of the postmarketing safety reports to the Agency, and are 
finalizing proposed Sec.  514.80(d) without change. The rule requires 
applicants and nonapplicants to submit a waiver request to us in 
writing. The initial request for a waiver 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). Applicants and 
nonapplicants should be prepared to comply with an Agency request for 
submission in an alternate format by maintaining the capability to 
submit paper reports using Form FDA 1932, if needed.
    In addition to the comments specific to this rulemaking that we 
addressed previously in this preamble, we received general comments 
expressing views about matters that are not related to this rulemaking. 
Therefore, these general comments do not require a response.

V. Effective and Compliance Dates

    This rule is effective August 28, 2020. Applicants and 
nonapplicants must comply with the electronic submission requirement in 
the final rule when submitting their reports beginning on July 29, 
2021.

VI. Economic Analysis of Impacts

    We have examined the impacts of the final 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.'' 
This final rule is not an economically 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 certify that the final 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 issuing ``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 $156 
million, using the most current (2019) Implicit Price Deflator for the 
Gross Domestic Product. This final rule would not result in an 
expenditure in any year that meets or exceeds this amount.

[[Page 45509]]

    Currently, most submitters have chosen, voluntarily, to use 
electronic submission for the reports that would be affected by this 
final rule. As of 2016, 99.7 percent of postmarketing safety reports 
eligible for electronic submission were electronically submitted. Thus, 
this final rule would affect a small proportion of these reports.
    The quantifiable benefit of this rule is annual cost savings of 
$5,259 from reduced data entry time for CVM. The other benefits of this 
final rule would be to animal health and are not quantifiable. The main 
cost to this rule is a one-time upfront cost to industry of $73,500 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 $161 per year, for processing the waivers 
to the electronic reporting requirement. Annualizing these costs over a 
15-year time horizon (from 2018 to 2033), we estimate total annualized 
costs to be $6,139 at a 3 percent discount rate, and total annualized 
costs of $7,703 at a 7 percent discount rate. The annualized net 
benefit of this rule is -$880 at a 3 percent discount rate and -$2,444 
at a 7 percent discount rate. The present value of the net benefits is 
-$10,504 at a 3 percent discount rate and -$22,262 at a 7 percent 
discount rate over a 15-year time horizon.

                                   Table 1--Summary of Benefits and Costs in 2017 Dollars Over a 15-Year Time Horizon
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                   Units
                                                  Primary       Low        High    ------------------------------------
                   Category                      estimate    estimate    estimate      Year      Discount     Period                  Notes
                                                                                      dollars    rate  (%)    covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized................................      $5,259  ..........  ..........        2017           7          15  ................................
    Monetized $/year..........................       5,259  ..........  ..........        2017           3          15  ................................
    Annualized................................  ..........  ..........  ..........  ..........           7  ..........  ................................
    Quantified................................  ..........  ..........  ..........  ..........           3  ..........  ................................
    Qualitative...............................  ..........  ..........  ..........  ..........  ..........  ..........  ................................
Costs:
    Annualized................................       7,703  ..........  ..........        2017           7          15  ................................
    Monetized $/year..........................       6,139  ..........  ..........        2017           3          15  ................................
    Annualized................................  ..........  ..........  ..........  ..........           7  ..........  ................................
    Quantified................................  ..........  ..........  ..........  ..........           3  ..........  ................................
    Qualitative...............................  ..........  ..........  ..........  ..........  ..........  ..........  ................................
Transfers:
    Federal...................................  ..........  ..........  ..........  ..........           7  ..........  ................................
    Annualized Monetized $/year...............  ..........  ..........  ..........  ..........           3  ..........  ................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
                    From/To                     From:
                                                To:                                 ..........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Other.........................................  ..........  ..........  ..........  ..........           7  ..........  ................................
Annualized Monetized $/year...................  ..........  ..........  ..........  ..........           3  ..........  ................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
                    From/To                     From:
                                                To:                                 ..........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
      3State, Local or Tribal Government:
               3Small Business:
                    3Wages:
                   3Growth:
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In line with Executive Order 13771, in table 2 we estimate present 
and annualized values of costs and cost savings over an infinite time 
horizon. Based on these cost-savings this final rule would be 
considered a deregulatory action under Executive Order 13771. Our 
primary estimate for the present value of the net costs over an 
infinite time horizon is -$3,837 (or a cost savings of $3,837) at a 7 
percent discount rate and -$96,287 at a 3 percent discount rate in 2016 
dollars.

                                  Table 2--Executive Order 13771 Summary Table
                                 [In 2016 dollars over an infinite time horizon]
----------------------------------------------------------------------------------------------------------------
                                                         Lower       Upper                   Lower       Upper
                                            Primary      bound       bound      Primary      bound       bound
                                             (7%)        (7%)        (7%)        (3%)        (3%)        (3%)
----------------------------------------------------------------------------------------------------------------
Present Value of Costs..................     $69,720  ..........  ..........     $75,346  ..........  ..........
Present Value of Cost Savings...........     110,711  ..........  ..........     258,326  ..........  ..........
                                         -----------------------------------------------------------------------
    Present Value of Net Costs..........    (40,991)  ..........  ..........   (182,980)  ..........  ..........
Annualized Costs........................       4,880  ..........  ..........       2,260  ..........  ..........
Annualized Cost Savings.................       7,750  ..........  ..........       7,750  ..........  ..........
                                         -----------------------------------------------------------------------
    Annualized Net Costs................     (2,869)  ..........  ..........     (5,489)  ..........  ..........
----------------------------------------------------------------------------------------------------------------


[[Page 45510]]

    We have developed a comprehensive Economic Analysis of Impacts that 
assesses the impacts of the final rule. The full analysis of economic 
impacts is available in the docket for this final rule (Ref. 1) and at 
https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

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 final rule contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The 
title, description, and respondent description of the information 
collection provisions are shown in the following paragraphs with an 
estimate of the one-time and recurring reporting and recordkeeping 
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.
    Title: Records and Reports Concerning Experience with Approved New 
Animal Drugs--OMB Control Number 0910-0284--Revision.
    Description: This final rule revises 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 requires that they be submitted in an 
electronic form. The rule also provides a procedure for requesting a 
temporary waiver of the requirement.
    Description of Respondents: Respondents to the information 
collection provisions of this 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) through (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 final rule revises 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 as a ``courtesy copy'' 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)).
    We currently require 3-day alert reports to be submitted to the 
appropriate FDA District Office or local FDA resident post on paper 
(see Sec.  514.80(b)(1)). As noted previously, the regulation does not 
require electronic submission of 3-day field alert reports (Sec.  
514.80(b)(1)). These reports will continue to be submitted on paper 
Form FDA 1932 directly to the appropriate 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 as a ``courtesy copy,'' the 
applicant will be required to submit the report electronically. This 
will 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 final rule also revises these requirements to allow applicants 
or nonapplicants to request a temporary waiver from the electronic 
submission requirement for ``good cause'' shown. We anticipate that 
temporary waivers will only be needed in rare circumstances that impact 
an applicant's or nonapplicant's ability to report electronically, such 
as natural disasters, pandemics, and terrorism.
    In the February 14, 2018, proposed rule, we included an analysis of 
the information collection provisions of the proposal under the PRA and 
requested comments on four topics relevant to that analysis (83 FR 6480 
at 6487 through 6488). We have summarized and responded to these 
comments in sections IV.B. through IV.C., but have made no changes to 
the burden estimate in our proposed rule.
    We estimate the reporting burden of this collection of information 
as follows:

[[Page 45511]]



                                                    Table 3--Estimated Recurring Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                             Number of                        Average
                     21 CFR section                        Form FDA No.      Number of     responses per   Total annual     burden per      Total hours
                                                                            respondents     respondent       responses       response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Electronic submission of postmarketing safety reports               1932              15              18             270               1             270
 under Sec.   514.80(b)(1), (b)(2)(i) and (ii), (b)(3),
 and (b)(4)(iv)(A) and (C)..............................
Request for waiver, 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 3 shows the estimated recurring reporting burden associated 
with the final rule. In section II.F. of the Final Regulatory Impact 
Analysis (FRIA), we estimated that 15 firms submitted a paper Form FDA 
1932 report from 2011 to 2015 and thus will be affected by the rule's 
requirement to submit electronically. As stated in the FRIA, 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 FRIA, we also estimated the burdens associated with 
submission of waiver requests. We expect very few waiver requests (see 
section II.F.2. of the FRIA), estimating that one firm will request a 
waiver annually under Sec.  514.80(d)(2). We assume a waiver request 
takes 1 hour to prepare and submit to us. Together, this results in a 
total of 271 hours and 271 responses. We are also adding 1 hour to the 
paper reporting collection to reflect the new waiver request process 
under Sec.  514.80(d)(2).
    We estimate the recordkeeping burden of this collection of 
information as follows:

                              Table 4--Estimated One-Time Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
            Activity                 Number of      records per    Total annual     burden 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 4 shows the estimated one-time recordkeeping burden 
associated with the final 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.F. of the FRIA, we estimated that approximately 15 firms 
will be affected by this rule. We assume it will take an average of 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 rule 
(i.e., applicants and nonapplicants in the pharmaceutical industry 
already have the computer and internet capacity necessary to 
electronically submit postmarketing safety reports).
    The information collection provisions in this final rule have been 
submitted to OMB for review as required by section 3507(d) of the 
Paperwork Reduction Act of 1995. Before the effective date of this 
final rule, FDA will publish a notice in the Federal Register 
announcing OMB's decision to approve, modify, or disapprove the 
information collection provisions in this final rule. An Agency may not 
conduct or sponsor, and a person is not required to respond to, a 
collection of information unless it displays a currently valid OMB 
control number.

IX. Federalism

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

X. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this rule in accordance with the principles set 
forth in Executive Order 13175. We have determined that the rule does 
not contain policies that have substantial direct effects on one or 
more Indian Tribes, on the relationship between the Federal Government 
and Indian Tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian Tribes. Accordingly, we 
conclude that the rule does not contain policies that have tribal 
implications as defined in the Executive order and, consequently, a

[[Page 45512]]

tribal summary impact statement is not required.

XI. References

    1. Economic Analysis of Impacts; also available at: https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

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, 21 CFR part 
514 is 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); the fifth sentence of 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.

* * * * *

------------------------------------------------------------------------
                                                  21 CFR paragraph and
                   Purpose                               title
------------------------------------------------------------------------
 
                              * * * * * * *
What are the general requirements for          514.80(b)(4) Periodic
 submission of periodic drug experience         drug experience report.
 reports, e.g., method of submission,
 submission date and 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          514.80(d) Format for
 electronically?.                               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   514.80(e) Records to be
 required by this section?.                     maintained.
 
                              * * * * * * *
Where do I mail reports that are not required  514.80(g) Mailing
 to be submitted electronically?.               addresses.
 
                              * * * * * * *
------------------------------------------------------------------------

* * * * *
    (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 paragraphs (b)(1) and (2) of this section 
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.
* * * * *
    (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), (2), and (3) and (b)(4)(iv)(A) and (C) of this 
section, the method of analysis, and the interpretation of the results. 
* * *
* * * * *
    (d) Format for submissions--(1) Electronic submissions. Except as 
provided in paragraph (d)(2) of this section, 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 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

[[Page 45513]]

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) of this section and to FDA under paragraph (d)(2) of 
this section, and a computer-generated equivalent of Form FDA 2301 may 
be used for reports submitted to FDA under paragraph (b)(4) of this 
section. 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: July 2, 2020.
Stephen M. Hahn,
Commissioner of Food and Drugs.
[FR Doc. 2020-15441 Filed 7-28-20; 8:45 am]
BILLING CODE 4164-01-P


