[Federal Register Volume 84, Number 224 (Wednesday, November 20, 2019)]
[Notices]
[Pages 64085-64089]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25139]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-4533]


Compounding Animal Drugs From Bulk Drug Substances; Draft 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of draft guidance for industry (GFI) #256 entitled 
``Compounding Animal Drugs from Bulk Drug Substances.'' The draft 
guidance, if finalized, will describe FDA's current thinking about 
compounding animal drugs from bulk drug substances. FDA has generally 
exercised enforcement discretion with regard to animal drug compounding 
from bulk drug substances under certain circumstances when no other 
medically appropriate treatment options exist. This draft guidance, a 
continuation of this practice, is intended to provide additional 
information and clarity to veterinarians and pharmacists about FDA's 
current thinking with respect to animal drug compounding from bulk drug 
substances. FDA previously published draft guidance on this issue for 
public comment in May 2015 (Draft GFI #230, ``Compounding Animal Drugs 
from Bulk Drug Substances''). We received over 150 comments on that 
draft guidance. Based on those comments, we decided to withdraw the May 
2015 draft guidance and publish this draft guidance for public comment.

DATES: Submit either electronic or written comments on the draft 
guidance by February 18, 2020 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance. Submit either electronic or written comments 
on the proposed collection of information by February 18, 2020.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

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-2018-D-4533 for ``Compounding Animal Drugs From Bulk Drug 
Substances.'' Received comments 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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the 
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, 
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. 
Send one self-addressed adhesive label to assist that office in 
processing your requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: With regard to this draft guidance: 
Eric

[[Page 64086]]

Nelson, Division of Compliance (HFV-230), Center for Veterinary 
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, 
MD 20855, 240-402-7001, [email protected].
    With regard to the proposed collection of information: Domini Bean, 
Office of Operations, Food and Drug Administration, Three White Flint 
North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-
5733, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of draft GFI #256 entitled 
``Compounding Animal Drugs from Bulk Drug Substances.'' FDA has 
generally exercised enforcement discretion with regard to animal drug 
compounding from bulk drug substances under certain circumstances when 
no other medically appropriate treatment options exist. This draft 
guidance, a continuation of this practice, is intended to provide 
additional information and clarity to veterinarians and pharmacists 
about FDA's current thinking with respect to animal drug compounding 
from bulk drug substances. We previously announced the availability of 
a draft guidance addressing this issue (GFI #230, ``Compounding Animal 
Drugs from Bulk Drug Substances'') in the Federal Register of May 19, 
2015 (80 FR 28624). In response to the comments received on GFI #230, 
we decided not to finalize that draft guidance, and instead are issuing 
draft GFI #256 for comment. If finalized, this draft guidance will 
describe the circumstances under which, based on our current 
understanding of the risks of animal drugs compounded from bulk drug 
substances, FDA does not intend to take enforcement action against 
pharmacies and veterinarians who compound animal drugs for violations 
of the FD&C Act's requirements for: (1) Approval; (2) adequate 
directions for use; and (3) current good manufacturing practices.
    Elsewhere in this issue of the Federal Register, FDA is requesting 
nominations for bulk drug substances to be included on the ``List of 
Bulk Drug Substances for Compounding Office Stock Drugs for Use in 
Nonfood-Producing Animals or Antidotes for Food-Producing Animals'' 
(the List) described in draft GFI #256. That Federal Register notice 
describes information needed by FDA to evaluate nominations and 
explains when FDA will include bulk drug substances on the List; such 
nominations will be collected in a separate docket. The List is 
available at http://wcms.fda.gov/FDAgov/AnimalVeterinary/ComplianceEnforcement/UnapprovedAnimalDrugs/ucm596211.htm.

II. Specific Topic for Comment

    In addition to any other comments on the draft guidance, we are 
specifically requesting comments on section III.A.5 of the draft 
guidance. That section provides that if a compounded drug contains the 
same active moiety as a marketed FDA-approved, conditionally approved, 
or indexed animal drug or an FDA-approved human drug but as a different 
salt, ester, or other noncovalent derivative, there should be a 
difference between the compounded drug and the FDA-approved, 
conditionally approved, or indexed animal drug or FDA-approved human 
drug that will produce a clinical difference in the patient and the 
medical rationale is documented in the prescription, or if a 
veterinarian is compounding the drug, the medical rationale is noted in 
the patient's medical record.
    FDA is concerned that compounding an animal drug using a different 
salt, ester, or other noncovalent derivative of the same active moiety 
used in a marketed FDA-approved, conditionally approved, or indexed 
animal drug or FDA-approved human drug can affect the absorption, 
distribution, metabolism, excretion, and stability of the compounded 
animal drug. All of these factors contribute to a drug's safety and 
effectiveness.
    FDA is also concerned that compounding an animal drug from a 
different salt, ester, or other noncovalent derivative of the same 
active moiety as a marketed FDA-approved, conditionally approved, or 
indexed animal drug or FDA-approved human drug may impact the 
incentives for seeking legal marketing status of a new animal drug 
(i.e., approval, conditional approval, or indexing). Unlimited 
compounding using a different salt, ester, or other noncovalent 
derivative could cause a disincentive for new animal drug sponsors to 
continue to research and develop innovative new animal drugs.
    However, FDA believes that in some cases the prescribing 
veterinarian may determine that a new animal drug from a different 
salt, ester, or other noncovalent derivative of the same active moiety 
as a marketed FDA-approved, conditionally approved, or indexed animal 
drug or FDA-approved human drug will produce a clinical difference for 
the identified patient. Under the draft guidance, a pharmacy could 
compound such an animal drug if the prescribing veterinarian documents 
such a determination on the prescription, or if a veterinarian is 
compounding the drug, the medical rationale is noted in the patient's 
medical record.
    FDA invites public comment on this issue.

III. Significance of Guidance

    This Level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
if finalized, will represent the current thinking of FDA on compounding 
animal drugs from bulk drug substances. It does not establish any 
rights for any person and is not binding on FDA or the public. You can 
use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations

IV. Paperwork Reduction Act of 1995

    This draft guidance contains proposed information collection 
provisions that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 
U.S.C. 3501-3521). ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 
60-day notice in the Federal Register for each proposed collection of 
information before submitting the collection to OMB for approval. To 
comply with this requirement, we are publishing this notice of the 
proposed collection of information set forth in this document.
    With respect to the collection of information associated with this 
draft guidance, we invite 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 collected; and (4) 
ways to minimize the burden of the information collected on 
respondents, including through the use of automated collection 
techniques, when appropriate, and other forms of information 
technology.
    Title: Compounding Animal Drugs from Bulk Drug Substances (OMB 
Control Number 0910-NEW).
    Description of Respondents: The proposed respondents are 
pharmacists

[[Page 64087]]

in either State-licensed pharmacies or Federal facilities, or 
veterinarians, who compound animal drugs from bulk drug substances.
    Description: The Center for Veterinary Medicine has written draft 
GFI #256 to address a perceived need for Agency guidance in its work 
with the animal health industry. The draft guidance describes FDA's 
current thinking, based on our current understanding of the risks of 
animal drugs compounded from bulk drug substances, and describes the 
circumstances under which FDA does not intend to take enforcement 
action against pharmacists and veterinarians who compound animal drugs 
from bulk drug substances.
    FDA estimates the burden of this collection of information as 
follows:
    Reporting: The draft guidance contains no new reporting provisions.
    Recordkeeping: The draft guidance contains a new recordkeeping 
provision. Our exercise of discretion is dependent upon our ability to 
assess whether the circumstances under which FDA would intend to 
exercise such discretion, as described in this draft guidance, exist. 
FDA staff may use pharmacy and veterinary records, among other things, 
to determine the circumstances surrounding the compounding activity. 
Except with regard to one proposed item, the routine business records 
kept by pharmacists who compound animal drugs from bulk drug substances 
and veterinarians who compound animal drugs from bulk drug substances, 
as well as veterinarians prescribing compounded animal drugs within a 
valid veterinarian-client-patient relationship, should be adequate to 
demonstrate that the circumstances described in the draft guidance 
exist.
    The draft guidance sets forth circumstances for the compounding of 
animal drugs from bulk drug substances. Section III.A.4 of the draft 
guidance provides that if the compounded drug is a copy of a marketed 
FDA-approved, conditionally approved, or indexed animal drug or an FDA-
approved human drug, there is a difference between the compounded drug 
and the FDA-approved, conditionally approved, or indexed animal drug or 
the FDA-approved human drug that will produce a clinical difference in 
the identified patient and the medical rationale is documented in the 
prescription, or if a veterinarian is compounding the drug, the medical 
rationale is noted in the patient's medical record. We tentatively 
conclude that it is usual and customary for veterinarians to document 
their medical rationale for using such a compounded product as a matter 
of maintaining an adequate medical record in routine practice; 
therefore, no burden has been estimated for the time it would take for 
a veterinarian to make this record.
    Section III.A.5 of the draft guidance provides that if the 
compounded drug contains the same active moiety as a marketed FDA-
approved, conditionally approved, or indexed animal drug or an FDA-
approved human drug but as a different salt, ester, or other 
noncovalent derivative, there is a difference between the compounded 
drug and the marketed FDA-approved, conditionally approved, or indexed 
animal drug or FDA-approved human drug that will produce a clinical 
difference in the identified patient. In such a case, the medical 
rationale is documented in the prescription, or if a veterinarian is 
compounding the drug, the medical rationale is noted in the patient's 
medical record. We tentatively conclude that it is usual and customary 
for veterinarians to document their medical rationale for using such a 
compounded product as a matter of maintaining an adequate medical 
record in routine practice; therefore, no burden has been estimated for 
the time it would take for a veterinarian to make this record.
    Section III.A.6 of the draft guidance provides that if the 
compounded animal drug has any of the same active ingredient 
moiety(ies) as one or more marketed FDA-approved, conditionally 
approved, or indexed animal drugs or FDA-approved human drugs, the 
compounder has determined and documented the reason(s) why the FDA-
approved, conditionally approved, or indexed animal drug(s) or FDA-
approved human drug(s) cannot be used as the source of the active 
ingredient(s). We tentatively conclude that it is not usual and 
customary in routine business practice for a compounder to document 
that rationale; therefore, we estimate the time it would take for a 
compounder to make this record, as follows.

                                                    Table 1--Estimated Annual Recordkeeping Burden 1
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                                                                Number of
                 Activity                      Number of       records per      Total annual       Average burden per recordkeeping        Total hours
                                             recordkeepers     recordkeeper       records
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Compounder recordkeeping to document the             7,500            1,360       10,200,000   0.017 (1 minute)........................         173,400
 rationale (section III.A.6 of the draft
 guidance).
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    According to the American Pharmacists Association, of the 
approximately 56,000 community-based pharmacies in the United States, 
about 7,500 pharmacies specialize in compounding services.\1\ We 
estimate that veterinarians will write approximately 11,339,400 
prescriptions for compounded animal drugs annually, as reported in 
table 2. Based on our experience with the regulation of compounded 
animal drugs, we estimate that from 75 to 90 percent of these 
prescriptions will require the compounder to document the rationale 
described in section III.A.6 of the draft guidance. Using the upper-
bound estimate of 90 percent, approximately 10,205,460 prescriptions 
(0.90 x 11,339,400 prescriptions) will require compounders to keep the 
additional record. Dividing these prescriptions equally among the 
approximately 7,500 compounding pharmacies, we estimate that the 7,500 
compounding pharmacies will, on average, each produce approximately 
1,360 compounded animal drugs annually for a total of 10,200,000 filled 
prescriptions. We estimate that it will take approximately 1 minute 
(0.017 hours) to document the rationale described in section III.A.6 of 
the draft guidance for each compounded animal drug for a total of 
173,400 hours, as reported in table 1.
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    \1\ American Pharmacists Association, ``Frequently Asked 
Questions About Pharmaceutical Compounding,'' n.d., https://www.pharmacist.com/frequently-asked-questions-about-pharmaceutical-compounding (accessed March 19, 2019).
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    Section III.C.3 of the draft guidance provides that if the 
compounded drug is compounded for use as an antidote for food-producing 
animals, the veterinarian establishes and documents a scientifically 
based withdrawal time that ensures residues of the antidote and the 
underlying toxin are not present in the animal at the time of slaughter 
or the veterinarian ensures the animal does not enter the food supply. 
We tentatively

[[Page 64088]]

conclude that it is usual and customary for veterinarians to establish 
and document a scientifically based withdrawal time as a matter of 
maintaining an adequate medical record in routine practice; therefore, 
no burden has been estimated for the time it would take for a 
veterinarian to make this record.
    Under 5 CFR 1320.3(b)(2), the time, effort, and financial resources 
necessary to comply with a collection of information are excluded from 
the burden estimate if the reporting, recordkeeping, or disclosure 
activities needed to comply are usual and customary because they would 
occur in the normal course of activities. As discussed, we tentatively 
conclude that it is usual and customary for veterinarians to keep, in 
the normal course of their activities, the type of records described in 
the draft guidance in sections III.A.4, III.A.5, and III.C.3; 
therefore, no burden has been estimated for such veterinary 
recordkeeping.
    Third-Party Disclosure: Section III.A.3 of the draft guidance 
provides that the compounded drug should be dispensed, after receipt of 
a prescription for an identified patient from the veterinarian acting 
within a valid veterinarian-client-patient relationship (VCPR), 
directly to the prescribing veterinarian or to the patient's owner or 
caretaker. We tentatively conclude that it is usual and customary for 
veterinarians to write prescriptions for an identified patient in the 
normal course of their activities; therefore, no burden has been 
estimated for the time it would take for a veterinarian to write a 
prescription.
    However, the draft guidance sets forth additional third-party 
disclosure provisions. Section III.A.4 of the draft guidance provides: 
If the compounded drug is a copy of a marketed FDA-approved, 
conditionally approved, or indexed animal drug or an FDA-approved human 
drug, there is a difference between the compounded drug and the FDA-
approved, conditionally approved, or indexed animal drug or an FDA-
approved human drug that will produce a clinical difference in the 
identified patient, ``and the medical rationale is documented in the 
prescription. . . .'' For example, the veterinarian could state that, 
``The patient requires a 1.0% solution and the FDA-approved solution is 
0.1%.'' In addition, Section III.A.5 of the draft guidance sets forth 
the following additional third-party disclosure provisions: (1) If the 
compounded drug contains the same active moiety as a marketed FDA-
approved, conditionally approved, or indexed animal drug or an FDA-
approved human drug but as a different salt, ester, or other 
noncovalent derivative; (2) if there is a difference between the 
compounded drug and the marketed FDA-approved, conditionally approved, 
or indexed animal drug or FDA-approved human drug that will produce a 
clinical difference in the identified patient; and (3) ``the medical 
rationale is documented in the prescription. . . .'' We tentatively 
conclude that it is not usual and customary for veterinarians to 
include either one of these medical rationales in a prescription in the 
normal course of their activities; therefore, we estimate the time it 
would take for a veterinarian to add a medical rationale to a 
prescription, as follows.

                                                Table 2--Estimated Annual Third-Party Disclosure Burden 1
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                                                                Number of
                 Activity                      Number of     disclosures per    Total annual         Average burden per disclosure         Total hours
                                              respondents       respondent      disclosures
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Statements on prescription (sections               113,394              100       11,339,400   0.017 (1 minute)........................         192,770
 III.A.4 and 5 of the draft guidance).
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We base our estimate of the number of respondent veterinarians on 
the American Veterinary Medical Association's Market Research 
Statistics for 2018.\2\ We estimate that approximately 113,394 
veterinarians will, on average, each produce approximately 100 
prescriptions for compounded animal drugs annually for a total of 
11,339,400 prescriptions. We also estimate that it will take 
approximately 1 minute (0.017 hours) to include the statement discussed 
in section III.A.5 of the draft guidance on each prescription for a 
total of 192,769.8 hours, rounded to 192,770 hours third-party 
disclosure burden, as reported in table 2.
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    \2\ The AVMA's Market Research Statistics--U.S. Veterinarians--
2018 can be found at this URL: https://www.avma.org/KB/Resources/Statistics/Pages/Market-research-statistics-US-veterinarians.aspx.
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    In addition, the draft guidance provides for the labeling of animal 
drugs compounded from bulk drug substances. The draft guidance 
indicates in sections III.A.8, III.B.6, and III.C.5 that pharmacists 
and veterinarians should label the compounded drug with a variety of 
information including: (1) The name of the drug; (2) the strength of 
the drug; (3) identifying information about the patient including the 
species of the patient, the name of the patient, (4) identifier for the 
individual animal (e.g., horse in stall X), or identification of a 
group of animals (e.g., dogs in shelter kennel X); (5) indications for 
which the drug will be used (for certain animal drugs without a patient 
specific prescription (i.e., office stock) and compounded drugs for use 
as antidotes for food-producing animals); (6) the name, address, and 
contact information for the compounding pharmacy or compounding 
veterinarian and name of prescribing veterinarian (for office stock, 
the name, address, and contact information for the veterinarian 
ordering the office stock); (7) the beyond use date; and (8) for 
compounded drugs for use as antidotes for food-producing animals, the 
veterinarian-determined withdrawal time. We tentatively conclude that 
it is usual and customary for pharmacists and veterinarians to include 
such information on the labels of compounded animal drugs in the normal 
course of their activities; therefore, no burden has been estimated for 
the time it would take for such labeling.
    Finally, sections III.A.8 and III.C.5 of the draft guidance 
indicates that pharmacists and veterinarians should include on the 
label of any compounded animal drug from bulk drug substances these 
three statements:
     ``Report adverse events to FDA using online Form FDA 
1932a'';
     ``This is a compounded drug''; and
     ``Caution: Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.''
    Similarly, section III.B.6 of the draft guidance indicates that 
pharmacists and veterinarians should include on the label of any animal 
drug compounded from bulk drug substances as office stock these four 
statements:

[[Page 64089]]

     ``Report adverse events to FDA using online Form FDA 
1932a'';
     ``This is a compounded drug'';
     ``Not for use in food-producing animals''; and
     ``Caution: Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.''
    We tentatively conclude that these label statements are public 
disclosures of information originally supplied by the Federal 
Government to the recipient for the purpose of disclosure to the public 
(5 CFR 1320.3(c)(2)) and are therefore not subject to review by OMB 
under the PRA. Thus, no burden has been estimated for the time it would 
take for such labeling.
    The draft guidance also refers to previously approved collections 
of information found in FDA regulations. These collections of 
information are subject to review by OMB under the PRA. The collections 
of information regarding voluntary reporting of adverse drug 
experiences or product/manufacturing defects on Form FDA 1932a, 
``Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product 
Defect Report,'' have been approved under OMB control number 0910-0284.
    Before the proposed information collection provisions contained in 
this draft guidance become effective, we will publish a notice in the 
Federal Register announcing OMB's decision to approve, modify, or 
disapprove the proposed information collection provisions. 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.

V. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or 
https://www.regulations.gov.

    Dated: November 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25139 Filed 11-19-19; 8:45 am]
 BILLING CODE 4164-01-P