Form FDA 3744 FDA 3744 ANTIMICROBIAL ANIMAL DRUG DISTRIBUTION REPORT

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Center for Veterinary Medicine

Form Approved: OMB No. 0910-0659
Expiration Date: 3/31/2013
(See Burden Statement below)

ANTIMICROBIAL ANIMAL DRUG
DISTRIBUTION REPORT
Firm and Application Information

Application Type

Application Number

Firm Name

Date Submitted

Food Animal Dosage Form Information
Dosage Form(s)

Production Class(es)

Animal Species Category

Indication(s)
Food Animal

Food and Non-Food Animal

Target Food Animal(s)

Please complete the form and
submit it to the address below.
Food and Drug Administration
Center for Veterinary Medicine
7500 Standish Place, HFV-199
Rockville, MD 20855
FORM FDA 3744 (12/09)

Public reporting burden for this collection of information is estimated to average
3.0 hours per response, including the time for reviewing instructions, searching
existing data sources, gathering and maintaining the data needed, and completing
and reviewing the collection of information. Send comments regarding this
burden estimate or any other aspect of this collection of information, including
suggestions for reducing this burden, to the address to the right.

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
1350 Piccard Drive, Room 400
Rockville, MD 20850

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.
PSC Graphics (301) 443-1090

EF

Page ___

Total of All Quantities Sold or Distributed (Domestic and Export)
1st Active Ingredient
2nd Active Ingredient
3rd Active Ingredient

Domestic Quantities
Domestic Quantities Sold/Distributed by Month –
Unit of Measure for 1st Active Ingredient

YEAR:

Jan

Feb

Domestic Quantities Sold/Distributed by Month –
Unit of Measure for 2nd Active Ingredient

Mar

Apr

May

Jun

Jul

Aug

Domestic Quantities Sold/Distributed by Month –
Unit of Measure for 3rd Active Ingredient

Sep

Oct

Nov

Dec

Annual
Total

1st Active Ingredient
2nd Active Ingredient
3rd Active Ingredient

Export Quantities
Export Quantities Sold/Distributed by Month –
Unit of Measure for 1st Active Ingredient

YEAR:

Jan

Feb

Export Quantities Sold/Distributed by Month –
Unit of Measure for 2nd Active Ingredient

Mar

Apr

May

Jun

Jul

Export Quantities Sold/Distributed by Month –
Unit of Measure for 3rd Active Ingredient

Aug

Sep

Oct

Nov

Dec

Annual
Total

1st Active Ingredient
2nd Active Ingredient
3rd Active Ingredient

FORM FDA 3744 (12/09)

Page ___

Individual Product Information
Dosage Form

Container Size

Container Size Units

1st Active Ingredient

2nd Active Ingredient

3rd Active Ingredient

1st Active Ingredient Strength – Numerator Number

2nd Active Ingredient Strength – Numerator Number

3rd Active Ingredient Strength – Numerator Number

1st Active Ingredient Strength – Numerator Unit

2nd Active Ingredient Strength – Numerator Unit

3rd Active Ingredient Strength – Numerator Unit

1st Active Ingredient Strength – Denominator Number

2nd Active Ingredient Strength – Denominator Number

3rd Active Ingredient Strength – Denominator Number

1st Active Ingredient Strength – Denominator Unit

2nd Active Ingredient Strength – Denominator Unit

3rd Active Ingredient Strength – Denominator Unit

Quantities of Individual Product Sold or Distributed (Domestic and Export)
Domestic and Export Quantities Sold/Distributed by
Month – Unit of Measure for 1st Active Ingredient

YEAR:

Jan

Feb

Mar

Domestic and Export Quantities Sold/Distributed by
Month – Unit of Measure for 2nd Active Ingredient

Apr

May

Jun

Jul

Aug

Domestic and Export Quantities Sold/Distributed by
Month – Unit of Measure for 3rd Active Ingredient

Sep

Oct

Nov

Dec

Annual
Total

1st Active Ingredient
2nd Active Ingredient
3rd Active Ingredient

FORM FDA 3744 (12/09)

Page ___

INSTRUCTIONS FOR COMPLETION OF FORM FDA 3744
General Directions for Use of the Form
This form may be used by sponsors of a new animal drug application (NADA),
abbreviated new animal drug application (ANADA), or conditionally approved
new animal drug application that contains an antimicrobial active ingredient to
submit the antimicrobial animal drug distribution report required by section
512(l)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(l)(3)),
as enacted by Title 1, Section 105 of the Animal Drug User Fee Amendments
of 2008 (110 P.L. 316; 122 Stat. 3509). For sponsors of more than one such
application, use a separate Form FDA 3744 for each application. Where the
instructions specify use of structured product labeling (SPL) terminology for
dosage form, units, etc., only use such terminology.

FIRM AND APPLICATION INFORMATION

for each dosage form and the corresponding target food-producing animal(s),
production classes, and indications information. If an application has more
than one dosage form and the approved labeling for these dosage forms is
identical with respect to target food-producing animals, production classes,
and indications, then the information may be presented on a single Form FDA
3744 (i.e., simply list all of the dosage forms in the “Dosage Form(s)” field,
followed by the target food-producing animal(s), production classes, and
indications applicable to these dosage forms).
Dosage Form: Enter the dosage form using the terminology on the FDA
website for Structured Product Labeling (go to: www.fda.gov/ForIndustry/
DataStandards/StructuredProductLabeling/default.htm and click the link for
Dosage Forms).

Application Number: Enter the application number. The application number
should include leading zeros.

Animal Species Category: Check the “Food Animal” box if the approved
labeling for the dosage form includes only indications for food-producing
animal species. Check the “Food and Non-Food Animal” box if the approved
labeling for the dosage form includes indications for both non food-producing
animal species and food-producing animal species.

Firm Name: Enter the name of the application holder. For the purposes of
this form, the name is equivalent to applicant or sponsor name.

Target Food Animal: Enter all the target food-producing animals as species
for the first dosage form. Examples include cattle, fish, turkey, chicken, etc.

Date Submitted: Enter date as MM/DD/YYYY.

Production Class: Enter all the production classes for that target foodproducing animal, if applicable. Examples include breeding swine; cattle,
calves, excluding veal calves; chicken, not laying eggs for human
consumption.

Application Type: Enter ANADA, NADA or Conditional Approval.

Page Number: The page number block is at the bottom of the page. Enter
“1” for the first page, and continue with the page numbering as each page is
completed and printed.

FOOD ANIMAL DOSAGE FORM INFORMATION
General Directions for Completing This Section
Complete this section for each dosage form covered by an application such
that the target food-producing animals, production classes, and indications
on the approved label for each dosage form are reported. If the approved
labeling for a dosage form is indicated for non food-producing animals only,
the dosage form does not need to be reported; however, if the labeling for
the dosage form includes indications for food-producing animals or for both
food-producing and non food-producing animals, report the dosage form).
If an application has more than one dosage form and the approved labeling
for these dosage forms is not identical with respect to target food-producing
animals, production classes, and indications, use a separate Form FDA 3744
FORM FDA 3744 (12/09)

Indications: Enter all the indications for species/production classes.

TOTAL OF ALL QUANTITIES SOLD OR DISTRIBUTED
(DOMESTIC AND EXPORT)
General Directions for Completing This Section
Complete this section for each application. This section only needs to be
completed once for each application (i.e., if multiple Form FDA 3744s are used
to report an application because of multiple dosage forms, container sizes, or
strengths, this section only needs to be completed once, on the first Form FDA
3744). The cumulative domestic quantities of active antimicrobial ingredients
and cumulative exported quantities of active antimicrobial ingredients should
be reported for all combinations of dosage forms, container sizes,
INSTRUCTIONS – Page i

and strengths for all antimicrobial active ingredients (i.e., if an application is
available in an oral suspension, tablet, and capsule form, then the summation
of their domestic and/or exported quantities sold or distributed should be
reported). Only include in this section those quantities of drugs that have
been reported as sold or distributed under the “Individual Product Information”
section, below. If the approved labeling for a particular product (i.e., dosage
form, strength, and/or container size) is indicated for non food-producing
animals only, that amount is not to be reported under the “Individual Product
Information” section (see directions for that section, below) and should not be
included in the total quantity of antimicrobial active ingredients reported in this
section.
1st Active Ingredient: Enter the first antimicrobial active ingredient, e.g.,
lincomycin hydrochloride” using the “Preferred Substance Name” from the
list on the FDA SPL website (go to: www.fda.gov/ForIndustry/DataStandards/
StructuredProductLabeling/default.htm and click the link for Unique
Ingredient Identifiers (UNII), Preferred Substance Names, and their Identified
Synonyms).
2nd and 3rd Active Ingredient: Enter the second antimicrobial active
ingredient, if applicable. If there are more than three antimicrobial active
ingredients, use a separate Form FDA 3744 to include the information about
the additional active ingredient(s). In this case, complete all sections of page
one of this form template except the Food Animal Dosage Form Information.

Domestic Quantities
Domestic Quantities Sold/Distributed by – Unit of Measure for 1st Active
Ingredient: Enter the appropriate unit of measure for the amounts of all
antimicrobial active ingredient quantity sold or distributed.
For example, if 500 cases of 100 mL bottles @ 200 mg lincomycin
hydrochloride/1 mL, each case containing 6 bottles, were distributed, enter
“g” since the calculated quantity would amount to 60,000 grams.
Year: Enter the calendar year for which the data are being reported. For
example, enter “2009.”
1st Active Ingredient: Enter the numeric value of the amount for the first
antimicrobial active ingredient sold or distributed domestically for the
application by month and annual total. Each monthly total is the sum of all
domestic sales and distribution (i.e., by the sponsor and all distributors, for
all dosage forms, container sizes, and strengths).
FORM FDA 3744 (12/09)

For example, if 500 cases of 100 mL bottles @ 200 mg lincomycin
hydrochloride/1 mL, each case containing 6 bottles, were distributed/sold
during the month of January, enter “60,000” since the calculated quantity
would amount to 60,000 grams. Ensure that there are five significant
figures (i.e., instead of entering “60” for “60 kg,” enter “60,000” for 60,000
g).
If 1250 bottles of 1000 tablet bottles @ 25 mg/1 tablet were distributed,
enter “31,250” since the calculated quantity would amount to 31,250
grams.
Continue entering monthly distribution amounts for February through
December of the calendar year. Enter the total amount distributed in that
year.
Returned Products: When product is sold or distributed and returned,
subtract the returned amount from the monthly total (in whole container
sizes).
2nd and 3rd Active Ingredients: Enter the numeric value of the amount(s)
of the second and third antimicrobial active ingredients that are sold or
distributed domestically for the application or conditional approval in the
same manner and on the same form as the 1st active ingredient. If there are
more than 3 active ingredients, use a separate Form FDA 3744 to include
the information about the additional active ingredient(s). The unit of measure
for 2nd and 3rd active ingredients does not have to be identical to the 1st
Active Ingredient Unit.

Export Quantities
Export Quantities Sold/Distributed by – Unit of Measure for 1st Active
Ingredient: Enter the appropriate unit of measure for the amounts of all
antimicrobial active ingredient quantity sold or distributed. The unit of measure
does not have to be identical to the “1st Active Ingredient Unit” entered under
“Domestic Quantities.”
For example, if 300 cases of 100 mL bottles @ 200 mg lincomycin
hydrochloride/1 mL, each case containing 6 bottles, were distributed during
the month of January, enter “g” since the calculated quantity would amount
to 36,000 grams.
Year: Enter the calendar year for which the data are being reported. For
example, enter “2009.”
INSTRUCTIONS – Page ii

1st Active Ingredient: Enter the numeric value of the amount for the first
antimicrobial active ingredient sold or distributed for export for the application
by month and annual total. Each monthly total is the sum of all exported sales
and distribution (i.e., by the sponsor and all distributors, for all dosage forms,
container sizes, and strengths).
For example, if 300 cases of 100 mL bottles @ 200 mg lincomycin
hydrochloride/1 mL, each case containing 6 bottles, were distributed, enter
“36,000” in the box for January since the calculated quantity would amount
to 36,000 grams.
If 1250 bottles of 1000 tablet bottles @ 25 mg/1 tablet were distributed,
enter “31,250” since the calculated quantity would amount to 31,250
grams.
Continue entering monthly distribution amounts for February through
December of the calendar year. Enter the total amount distributed in that
year.
Returned Products: When product is sold or distributed and returned,
subtract the returned amount from the monthly total (in whole container
sizes).
2nd and 3rd Active Ingredients: Enter the numeric value of the amount(s)
of the second and third antimicrobial active ingredients that are sold or
distributed for export for the application or conditional approval in the same
manner and on the same form as the 1st active ingredient. If there are more
than 3 active ingredients, use a separate Form FDA 3744 to include the
information about the additional active ingredient(s). The unit(s) of measure
does not have to be identical to the unit of measure used for the 1st Active
Ingredient.

INDIVIDUAL PRODUCT INFORMATION
General Directions for Completing This Section
Complete this section for each combination of dosage form, container size,
and strength of product marketed. For example, if a particular dosage form
has 3 strengths, complete this section on a separate Form FDA 3744 for each
combination of dosage form and strength, such that a total of 3 separate forms
are used. If multiple container sizes are available in a given dosage form and
strength, use a separate Form FDA 3744 for each combination of dosage
form, container size, and strength. Using the example of a dosage form with
three strengths, if each strength is marketed in 3 different container sizes, use
a separate page for each combination of dosage form, strength, and container
FORM FDA 3744 (12/09)

size, such that a total of 9 separate forms are used. If there are multiple
dosage forms, container sizes, and/or strengths requiring the use of more than
one form, the information in the “Firm and Application,” “Food Animal Dosage
Form Information,” “Total of All Quantities Sold or Distributed (Domestic and
Export),” “Domestic Quantities,” and “Export Quantities” sections of the form
do not need to be filled out again on the additional forms used.

Quantities of Antimicrobial Active Ingredients to be Reported
If the approved labeling for a particular product(s) (i.e., dosage form, strength,
and/or container size) includes indications for only food-producing animals,
report all quantities sold or distributed. If the approved labeling includes
indications for both food-producing and non food-producing animal species,
report all quantities sold or distributed. If the approved labeling for a particular
product is indicated for non food-producing animals only, do not report the
quantity sold or distributed for that product.
Dosage Form: Enter the dosage form for the first new animal drug using the
terminology on the FDA website for Structured Product Labeling (go to:
www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/
default.htm and click the link for Dosage Forms).
Container Size: Enter the container size without units for the Product; e.g., if
the product is manufactured in 100 mL vials, enter “100.”
Container Size Units: Enter the units for the container size, choosing
the SPL Units of Measure or Units of Presentation from those listed
on the FDA SPL website (go to: www.fda.gov/ForIndustry/DataStandards/
StructuredProductLabeling/default.htm and click either the link for Units of
Measure or the link for Units of Presentation). If the unit is based on the
standards of the metric system/International System of Weights and
Measures, refer to the SPL Units of Measure list; if the unit is not present on
this list, refer to the SPL Units of Presentation list. For example, if the product
is manufactured in 100 mL vials, since “mL” is a metric system unit, refer to
the SPL Units of Measure list; or if the product is manufactured in 100 tablet
bottles, enter “tablet” from the Units of Presentation SPL list since tablet is not
a Unit of Measure.
1st Active Ingredient: Enter the first antimicrobial active ingredient, e.g.,
“lincomycin hydrochloride,” using the “Preferred Substance Name” from the
list on the FDA SPL website (go to: www.fda.gov/ForIndustry/DataStandards/
StructuredProductLabeling/default.htm and click the link for Unique
Ingredient Identifiers (UNII), Preferred Substance Names, and their Identified
Synonyms).
INSTRUCTIONS – Page iii

1st Active Ingredient Strength – Numerator Number: Enter the strength
without units for the first antimicrobial active ingredient; e.g., if the product is
manufactured at 200 mg/1 mL, enter “200."
1st Active Ingredient Strength – Numerator Unit: Enter the numerator unit
of the numerator strength for the first antimicrobial active ingredient, choosing
from the SPL Units of Measure list. For the 200 mg/1 mL example, enter the
numerator unit in the box, e.g., “mg.”
1st Active Ingredient Strength – Denominator Number: Enter the
denominator without units for the first antimicrobial active ingredient; e.g., if
the product is manufactured as 200 mg/1 mL, enter “1.”
1st Active Ingredient Strength – Denominator Unit: Enter the unit for the
first antimicrobial active ingredient, choosing from the SPL Units of Measure
list or the SPL Units of Presentation list. For the 200 mg/1 mL example, the
denominator unit is “mL.” For the 25 mg/1 tablet example, the denominator
unit is “tablet.”
2nd and 3rd Active Ingredients: For dosage forms with more than one
antimicrobial active ingredient, enter the antimicrobial active ingredient name
and strength information for the second and third antimicrobial active
ingredients in the same manner and on the same form as the first antimicrobial
active ingredient. If there are more than three antimicrobial active ingredients,
this section will have to be filled out to include the additional ingredients. The
first page of this form does not need to be filled out again. Number the
additional pages in sequence.

QUANTITIES OF INDIVIDUAL PRODUCT SOLD OR DISTRIBUTED
(DOMESTIC AND EXPORT)
General Directions for Completing This Section

measure does not have to be identical to the unit used for the “1st Active
Ingredient Numerator Unit” in the “Total of All Quantities Sold or Distributed
(Domestic and Export)” section.
For example, if 500 cases of 100 mL bottles @ 200 mg lincomycin
hydrochloride/1 mL, each case containing 6 bottles, were distributed, enter
“g” since the calculated quantity would amount to 60,000 grams.
Year: Enter the calendar year for which the data are being reported. For
example, enter “2009.”
1st Active Ingredient: Enter the numeric value of the amount of the first
antimicrobial active ingredient sold or distributed by month. Include all
domestic and exported product sold or distributed by the applicant and
distributors. Enter the numeric value for the total amount sold or distributed for
the year in the annual total.
For example, if 500 cases of 100 mL bottles @ 200 mg lincomycin
hydrochloride/1 mL, each case containing 6 bottles, were distributed
domestically and 200 cases exported, enter “84,000” since the calculated
quantity would amount to 84,000 grams.
Returned Products: When product is sold or distributed and returned,
subtract the returned amount from the monthly total (in whole container
sizes).
Continue entering monthly distribution amounts for February through
December of the calendar year. Enter the total amount distributed in that
year.
2nd and 3rd Active Ingredients: Enter the numeric value of the amount(s)
of the second and third antimicrobial active ingredients that are sold or
distributed domestically and for export for the application or conditional
approval in the same manner and on the same form as the 1st active
ingredient. If there are more than three active ingredients, use a separate
Form FDA 3744 to include the information about the additional active
ingredient(s).

Complete this section for all Form FDA 3744s created under the “Individual
Product Information” directions, above, such that the sale or distribution
information is reported for all combinations of dosage forms, container size
and units, and strengths for all antimicrobial active ingredients. Domestic and
exported quantities are reported together.

SUBMISSION OF FORM(S)

Domestic and Export Quantities Distributed by – Unit of Measure for 1st
Active Ingredient: Enter the appropriate unit of measure for the amounts of
all antimicrobial active ingredient quantity sold or distributed. The unit of

Submit the completed form to the Food and Drug Administration, Center for
Veterinary Medicine, 7500 Standish Place, HFV-199, Rockville, MD 20855.
Please attach the form to a signed cover letter.

FORM FDA 3744 (12/09)

INSTRUCTIONS – Page iv