Form 356 V 356 V Application for Approval of A New Animal Drug

Form Approved: OMB No. 0910-0032; Expiration Date: xx/xx/xxxx
See OMB Statement on Page 3.
APPLICATION OR INVESTIGATIONAL
FILE NUMBER

DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION

APPLICATION FOR APPROVAL OF A NEW ANIMAL DRUG
(OR SUBMISSION TO SUPPORT NEW ANIMAL DRUG APPROVAL)

DATE OF SUBMISSION

(Sections 512 and 571 of FFDCA and Title 21, Code of Federal Regulations, Part 514)
APPLICANT INFORMATION
APPLICANT NAME

CONTACT NAME (authorized representative or U.S. agent)

APPLICANT ADDRESS (Number, Street, City, State, Country, and ZIP or
Mail Code)

CONTACT ADDRESS (Number, Street, City, State and ZIP Code)

E-MAIL ADDRESS:
TELEPHONE NUMBER

FACSIMILE (FAX) NUMBER

TELEPHONE NUMBER

FACSIMILE (FAX) NUMBER

PRODUCT DESCRIPTION
ESTABLISHED NAME (e.g., USAN name)

PROPRIETARY NAME (trade name), IF ANY

PROPOSED MARKETING STATUS (check one)

DOSAGE FORM:

Prescription (Rx) (section 503(f)(1) of FFDCA)
DOSE or DOSE RANGE:

Over-the-Counter (OTC) (section 502(f)(1) of FFDCA)

ROUTE(S) OF ADMINISTRATION

Veterinary Feed Directive (VFD) (section 504 of FFDCA)
DESIGNATED NEW ANIMAL DRUG?

SPECIES AND, IF APPLICABLE, CLASS

Yes

No

DATE OF
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PROPOSED INDICATION(S) FOR USE

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APPLICATION DESCRIPTION
TYPE OF APPLICATION (check one, if applicable)

New Animal Drug Application (NADA) (section 512(b)(1) of FFDCA)

FOR AN ANADA, IDENTIFY THE FOLLOWING INFORMATION
FOR THE REFERENCE LISTED DRUG
Proprietary Name

Abbreviated New Animal Drug Application (ANADA) (section
512(b)(2) of FFDCA)
Application for Conditional Approval (section 571(a) of FFDCA)

Application Number
Holder of Approved Application

Administrative Application?
Yes

No

TYPE OF SUBMISSION (check one)
Submission of data or information to an Investigational File (and
Amending Submissions)
Submission to a Master File
Original Application
Supplement requiring review of safety or effectiveness data (21
CFR §514.8(c)(1))
Chemistry, Manufacturing and Controls: Supplement or Report
(also check specific type)
Prior Approval (21 CFR §514.8(b)(2))

Labeling Supplement (also check specific type)
Prior approval (21 CFR §514.8(c)(2))
CBE (21 CFR §514.8(c)(3))
Amendment to Pending Application, Supplement or MCSR
Reactivation of Application, Supplement, or MCSR
Request for renewal of conditionally approved Application (section
571(d)(1) of FFDCA)
Other (please describe) :

Changes Being Effected (CBE) – 30 day (21 CFR
§514.8(b)(3)(i))
CBE – Immediate (21 CFR §514.8(b)(3)(vi))
Minor Changes and Stability Report (MCSR) (21 CFR
§514.8(b)(4))

FORM FDA 356v (9/07)

PSC Graphics (301) 443-1090

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SUBMISSION CONTENT (Check each box that describes a type of information included in your submission)
To support an NADA or application for conditional approval

To support an ANADA

1. Identification (21 CFR §514.1(b)(1))

9. Identification

2. Table of contents and summary (21 CFR §514.1(b)(2))

10. Table of contents and summary

3. Technical sections

11. Technical sections

a. Labeling (21 CFR §514.1(b)(3)) (check one)
Draft (facsimile) labeling

a. Withdrawal period information (section 512(n)(1)(A)(ii) of
FFDCA)

Final printed labeling

b. Bioequivalence (section 512(n)(1)(E) of FFDCA) (check one)
Documentation supporting granting of request for waiver

b. Chemistry, manufacturing, and controls (21 CFR §514.1(b)(4)
and (5))

Bioequivalence study or information
c. Labeling (sections 512(n)(1)(F) and (G) of FFDCA) (check
one)

c. Human food safety (21 CFR §514.1(b)(7) and (8))
d. Target animal safety (TAS) (21 CFR §514.1(b)(8))

Draft (facsimile) labeling

e. Effectiveness (check one)

Final printed labeling

Substantial evidence of effectiveness (21 CFR
§514.1(b)(8))

d. Chemistry, manufacturing, and controls (section 512(n)(1)(G)
of FFDCA)

Reasonable expectation of effectiveness (section
571(a)(2)(B) of FFDCA)

e. Patent certification (section 512(n)(1)(H) of FFDCA)

f. Environmental impact (21 CFR §514.1(b)(14))

f. Environmental impact (21 CFR §25.15)

g. All other information (21 CFR §514.1(b)(8)(iv))

g. Freedom of information summary (21 CFR §514.11) (for
administrative application, submit FOI TSC letter)

h. Freedom of information summary (21 CFR §514.11) (for
administrative application, submit FOI TSC letter)

Other (please describe) :

4. Samples (21 CFR §514.1(b)(6)) (submit only on the request of
FDA)
5. For VFD drugs, submit copies of the VFD (21 CFR §514.1(b)(9))
6. Commitments required by 21 CFR §514.1(b)(11) and (12)
a. Labeling and advertising (21 CFR §514.1(b)(11))

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b. Shipping of approved drug intended for use in the
manufacture of animal feeds (21 CFR §514.1(b)(12)(i))
c. Good manufacturing practices (21 CFR §514.1(b)(12)(ii))
d. Good laboratory practice compliance statement (21 CFR
§514.1(b)(12)(iii))
7. Patent information on any patent which claims the drug (section
512(b)(1) of FFDCA)
8. User fee cover sheet (Form FDA 3546)
NUMBER OF
VOLUMES
SUBMITTED

DESCRIPTION OF ANY ELECTRONIC MEDIA SUBMITTED

CROSS REFERENCES (list applications or files, (e.g., investigational new animal drug files (INADs), generic INADs (JINADs), NADAs, and master
files) referenced in the current application, including by right(s) of reference)

FORM FDA 356v (9/07)

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CERTIFICATIONS
I certify that:
• I have personally reviewed this submission (or received assurances from qualified personnel) and determined that this submission and all supporting data, to the best of my knowledge and belief, are true, accurate, and complete,
• All copies (paper or electronic) of the submission are identical,
• For any information submitted by reference to a master file, investigational file, or application, the reference
was made with the belief that the information contained in the referenced file is true, accurate, and complete,
• The services of any person debarred under section 306(a) or (b) of FFDCA have not been used in any capacity related to this submission, and
• I am aware that there are significant penalties for submitting false information, including the possibility of fine
and imprisonment for knowing and willful violations (18 U.S.C. § 1001).
If this application is approved, I agree:
• To submit safety update reports as requested by FDA under its statutory authority or as provided for by regulation,
• To comply with all applicable statutes and regulations that apply to approved applications,
• Not to market this drug product until the Drug Enforcement Administration makes a final scheduling decision if this application applies to a drug product that FDA has proposed for scheduling under the Controlled
Substances Act, and
• To notify FDA of any change to the conditions established in this approval.
SIGNATURE OF RESPONSIBLE OFFICIAL

NAME AND TITLE (Printed or Typed)

DATE

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SIGNATURE OF U.S. AGENT (if applicable)

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NAME AND TITLE (Printed or Typed)

DATE

Paperwork Reduction Act Statement – A Federal 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. Public reporting burden for this collection of information averages
5 hours per response, including time for reviewing instructions and completing the form. Send comments regarding the burden estimate or
any other aspect of this collection of information to: Food and Drug Administration, Center for Veterinary Medicine, Policy and Regulations
Staff (HFV-6), 7519 Standish Place, Rockville, MD 20855.

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FORM FDA 356v (9/07)

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INSTRUCTIONS FOR COMPLETING AND SUBMITTING FORM FDA 356v
should include labeling language, and may include
Freedom of Information (FOI) information, relevant
to the specific technical section.

GENERAL INSTRUCTIONS
Applicant Information
Provide your name, address, and telephone and facsimile
numbers (including the country code if needed). This address will be the address of record we use for all contacts
initiated by us and not directly related to a submission.
Also provide the name of the individual who will serve
as your contact (i.e., your authorized representative or
U.S. agent). If you or your authorized representative do
not reside or have a place of business within the United
States, you must provide the name and address of a U.S.
agent as your contact. A U.S. agent is a person who is a
permanent resident of the United States and acts as your
agent. Your U.S. agent must also sign your application
(see 21 CFR §514.1(a)).

• Submission to a Master File: Data or information
submitted to a master file that may be referenced (by
the owner or a person granted a right of reference) to
support the approval of a new animal drug.
• Original Application: A complete application (i.e.,
containing all applicable technical sections or copies of technical section complete letters for all applicable technical sections) that you have not submitted
before.

Product Description

• Supplement Requiring Review of Safety or Effectiveness Data: A supplemental application (21
CFR §514.8(a)) requesting a change to an approved
application that requires FDA to review safety or effectiveness data (e.g., the addition of a new claim or
species). Note: An applicant may not supplement an
application for conditional approval to add indications
of use (section 571(g) of FFDCA).

Include all of the information necessary to identify the
drug product that is the subject of your submission. The
manufacturer or sponsor of a new animal drug for a minor
use or use in a minor species may request designation
under section 573(a) of FFDCA. Indicate whether your
drug has been declared a designated new animal drug
and, if so, the date of designation.

Application Description

• If you are submitting an application, check the appropriate box to identify whether you are submitting
a new animal drug application (NADA), an abbreviated NADA (ANADA), or application for conditional
approval. Please check whether the application is an
administrative application. If this is an ANADA, identify, for the reference listed new animal drug, the proprietary name of the reference listed drug, its NADA
number, and the name of the holder of the approved
NADA for the referenced listed drug.
• DO NOT check a box under Type of Application if
you are submitting information or data to an investigational file or master file. Instead, check the “submission of data or information to an investigational
file,” “submission to a master file,” or “other” under
type of submission and the appropriate item(s) from
the Submission Content list of items.
Type of Submission: Check the appropriate box.
• Submission of Data or Information to an Investigational File: Data or information (including amending data or information) supporting a single technical
section submitted for phased review. This submission
FORM FDA 356v (9/07)

F– Prior approval: A supplemental application for
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any change in the drug, production process, qual-

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Type of Application:

• Chemistry, Manufacturing, and Controls – Supplement or Report:

ity controls, equipment, or facilities that has a substantial potential to have an adverse effect on the
identify, strength, quality, purity, or potency of the
drug as these factors may relate to the safety or
effectiveness of the drug (21 CFR 514.8(b)(2)).
– Changes being effected (CBE) in 30 days: A
supplemental application for any change in the
drug, production process, quality controls, equipment, or facilities that has a moderate potential to
have an adverse effect on the identity, strength,
quality, purity, or potency of the drug as these factors may relate to the safety or effectiveness of the
drug. (See examples in 21 CFR §514.8(b)(3)(ii)).
You may commercially distribute the drug made
using the change 30 or more days after FDA receives your supplemental application unless FDA
informs you otherwise within 30 days of its receipt
of the application.
– Changes being effected (CBE): A supplemental
application for certain changes in the drug, production process, quality controls, equipment, or
facilities that have a moderate potential to have
an adverse effect on the identity, strength, quality,
purity, or potency of the drug as these factors may
relate to the safety or effectiveness of the drug
(for examples, see 21 CFR 514.8(b)(3)(vi)). You
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may commercially distribute the drug when FDA
receives your supplemental application.

8) should accompany each NADA and supplemental
NADA subject to fees. To determine if your NADA or
supplemental NADA is subject to an application fee,
see section 740(a)(1) of FFDCA.

– Minor changes and stability report (MCSR): An
annual report that documents changes in the drug,
production process, quality controls, equipment,
or facilities that have a minimal potential to have
an adverse effect on the identity, strength, quality,
purity, or potency of the drug as these factors may
relate to the safety or effectiveness of the drug (21
CFR §514.8(b)(4)).

• For submissions other than applications (e.g., a submission to an investigational file for phased review),
check only those items that apply and indicate the
order in which these sections appear in your submission in your table of contents. Do not check Labeling
or Freedom of Information Summary if the submission contains such information only as it relates to
a technical section. For administrative applications,
submit a copy of your FOI “technical section complete” letter.

• Labeling Supplement:
– Prior approval: A supplemental application requesting labeling changes that requires approval
before the drug may be distributed (for examples,
see 21 CFR §514.8(c)(2)).
– Changes being effected (CBE): A supplemental application requesting labeling changes that
can be placed into effect before approval. These
supplements request changes in labeling that
increase the assurance of drug safety (21 CFR
§514.8(c)(3)(i)) or that do not decrease the safety
of drug use (21 CFR §514.8(c)(3)(ii)).

• A complete ANADA should include items 9-11. A supplemental ANADA may omit statements made in the
approved application concerning which no change is
made.

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• The “other” category should be checked and include
a description of the submission when you are submitting certain information supporting a conditional approval (see instructions above) or when your submission does not fall into the above categories.

• Amendment to a Pending Application, Supplement, or MCSR: Any submission that provides additional information to an application or report while it
is under review.

Description of Submission

• Reactivation of an Application, Supplement, or
MCSR: Resubmission of an application or report to
address the deficiencies described in an incomplete
letter from FDA.

Cross References

• Other: Any submission that does not fit within one of
the types of submissions described above.
Submission Content: Please check each box that
describes a type of information that is included in your
submission. Note that items 1-7 apply to the submission
of NADAs and applications for conditional approval (or
to their supporting investigational files), item 8 applies
specifically to NADAs, and items 9-11 apply to ANADAs
(or to their supporting investigational files).
• A complete NADA and application for conditional
approval must include information and any right(s)
of reference to information for items 1-7 (21 CFR
§514.1; section 571(a)(2)(A), (B) and (C) of FFDCA).
A supplemental NADA may omit statements made in
the application concerning which no change is made.
If you are submitting information required by sections
571(a)(2)(D) – (F) of FFDCA to support conditional
approval, check “other” and describe the information
you are submitting. Indicate the order in which these
sections appear in your submission in your table of
contents. A completed User Fee Cover Sheet (item
FORM FDA 356v (9/07)

Enter the number of volumes you are submitting. Describe any electronic media in your submission.

List all investigational new animal drug files (INADs,
JINADs), new animal drug applications (NADAs, ANADAs,
applications for conditional approval), master files (VMFs,
DMFs, PMFs), or other applications or files referenced in
your current submission, including by “right of reference.”
If you reference data or information in any file you don’t
own, make sure a copy of your authorization to reference
such data or information is included with your submission
or has already been submitted to the file in which you
referenced it.

Signature
After carefully reading the certifications, sign and date the
form. Ordinarily only one person must sign the form, i.e.,
the applicant, or the applicant’s attorney, agent, or other
authorized official. However, if you do not reside or have
a place of business within the United States, your U.S.
agent must also sign the application.

INSTRUCTIONS FOR SUBMITTING AN
APPLICATION
1. Include a completed and signed Form FDA 356v
(pages 1 through 3) with all submissions relating to
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5. Include a comprehensive table of contents in your
submission (21 CFR §514.1(b)(2)).

new animal drug approval (i.e., NADAs, ANADAs,
applications for conditional approval, submissions of
data or information to an investigational file, supplements, amendments, reactivations, and MCSRs). The
completed form should be placed before the cover letter, table of contents, and submission.

6. Format your submission so each of your sections begins on a new page.
7. Sequentially number the pages of the submission.

2. Submit three identical copies of your submission (21
CFR §514.1(b)). A copy of the Form FDA 356v should
accompany each copy of your submission.

8. Send your submission and copies to:
Document Control Unit (HFV-199)
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place
Rockville, MD 20855

3. Place the applicant’s name and address and the proprietary name(s) (if available) and established name(s)
of the new animal drug on the front cover of each copy
of your submission (21 CFR §514.1(b)).
4. Fully describe the submission in your cover letter (e.g.,
for a supplemental application, describe the change(s)
you are seeking to the approved application).

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FORM FDA 356v (9/07)

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