[Federal Register Volume 83, Number 31 (Wednesday, February 14, 2018)]
[Proposed Rules]
[Pages 6480-6490]
[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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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:<PHONE_NUMBER>, 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,<PHONE_NUMBER>,
[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

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

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

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

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.

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:.............................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

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

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

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

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


[Federal Register Volume 82, Number 240 (Friday, December 15, 2017)]
[Notices]
[Pages 59944-59945]
[FR Doc No: 2017-26976]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Generic
Clearance for the Collection of Qualitative Feedback on Agency Service
Delivery

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew a generic information
collection. As part of a Federal Government-wide effort to streamline
the process to seek feedback from the public on service delivery, FAA
has an approved Generic Information Collection Request (Generic ICR):
``Generic Clearance for the Collection of Qualitative Feedback on
Agency Service Delivery''.

DATES: Written comments should be submitted by February 13, 2018.

ADDRESSES: Send comments to the FAA at the following address: Barbara
Hall, Federal Aviation Administration, ASP-110, 10101 Hillwood Parkway,
Fort Worth, TX 76177.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including: (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be

minimized without reducing the quality of the collected information.
The agency will summarize and/or include your comments in the request
for OMB's clearance of this information collection.

FOR FURTHER INFORMATION CONTACT: Barbara Hall at<PHONE_NUMBER>, or by
email at: [email protected].

SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0746.
    Title: Generic Clearance for the Collection of Qualitative Feedback
on Agency Service Delivery.
    Form Numbers: There are no FAA forms associated with this generic
information collection.
    Type of Review: Renewal of a generic information collection.
    Background: The information collection activity will garner
qualitative customer and stakeholder feedback in an efficient, timely
manner, in accordance with the Administration's commitment to improving
service delivery. By qualitative feedback we mean information that
provides useful insights on perceptions and opinions, but are not
statistical surveys that yield quantitative results that can be
generalized to the population of study. This feedback will provide
insights into customer or stakeholder perceptions, experiences and
expectations, provide an early warning of issues with service, or focus
attention on areas where communication, training or changes in
operations might improve delivery of products or services. These
collections will allow for ongoing, collaborative and actionable
communications between the Agency and its customers and stakeholders.
It will also allow feedback to contribute directly to the improvement
of program management.
    Feedback collected under this generic clearance will provide useful
information, but it will not yield data that can be generalized to the
overall population. This type of generic clearance for qualitative
information will not be used for quantitative information collections
that are designed to yield reliably actionable results, such as
monitoring trends over time or documenting program performance. Such
data uses require more rigorous designs that address: The target
population to which generalizations will be made, the sampling frame,
the sample design (including stratification and clustering), the
precision requirements or power calculations that justify the proposed
sample size, the expected response rate, methods for assessing
potential non-response bias, the protocols for data collection, and any
testing procedures that were or will be undertaken prior fielding the
study. Depending on the degree of influence the results are likely to
have, such collections may still be eligible for submission for other
generic mechanisms that are designed to yield quantitative results.
    Respondents: Approximately 11,000 Individuals and Households,
Businesses and Organizations, State, Local or Tribal Government.
    Frequency: Once per request.
    Estimated Average Burden per Response: 10 minutes.
    Estimated Total Annual Burden: 1833 hours.

    Issued in Fort Worth, TX, on December 8, 2017.
Barbara L. Hall,
FAA Information Collection Clearance Officer, Performance, Policy, and
Records Management Branch, ASP-110.
[FR Doc. 2017-26976 Filed 12-14-17; 8:45 am]
 BILLING CODE 4910-13-P