3908 Outsourcing Facilities for Human Drug Compounding Small

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. xxxx-xxxx

Outsourcing Facilities for Human Drug Compounding
Small Business Establishment Fee Reduction Request

Expiration Date: Xxxxxxx xx, 201x
See PRA Statement below.

Instructions for Filling Out Form FDA 3908: Outsourcing Facilities for
Human Drug Compounding – Small Business Establishment Fee Reduction Request
General Instructions

1(k) Email Address: Provide an email address of the
person identified in field 1(i).

To qualify for a small business fee reduction for a fiscal
year, the Outsourcing Facility’s Gross Annual Sales, both
compounding and non-compounding related, including the
sales of all affiliates, must total $1,000,000 or less for the
12 months ending April 1st of the previous fiscal year. An
Outsourcing Facility must complete and return the Small
Business Establishment Fee Reduction Request form to the
FDA for review by April 30th to receive a fee reduction for
the next fiscal year.

Section 2: Affiliate Information

1(a) Company Name: Provide the full legal name of the
company.

Affiliate is defined as a “business entity that has a
relationship with a second business entity if, directly
or indirectly—(A) one business entity controls, or has
the power to control, the other business entity; or (B) a
third party controls, or has power to control, both of the
business entities.” If the company has affiliates, provide
for each affiliate (domestic and foreign) associated with
the company; the name of the affiliate(s), the address, the
responsible point of contact’s name, phone number and
email address.

1(b) Address: Provide the street address of the physical
location. Do not include P.O. Box.

If the company does not have any affiliates, check the box
located in part 2 of this form.

Section 1: Company Information

1(c) Address: Provide additional information such as a
suite number or building number, if applicable.

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Section 3: Gross Annual Sales
Gross Annual Sales means the total worldwide gross annual
sales, in United States dollars, of the outsourcing facility’s
compounding and non-compounding related activities,
including the sales of all domestic and foreign affiliates.

1(d) City: Provide the city in which the company is located.
1(e) State: Provide the two letter state identifier for which
the company is located.

1(f) Zip Code: Provide the United States Postal Service zip
code where the company is located.

Section 4: Signature

1(g) DUNS Numbers: Dun and Bradstreet (D&B) provides
a DUNS Number. It is a unique nine digit identification
number for each physical location of your business.
Provide the unique nine digit DUNS number issued by
Dun and Bradstreet. To establish a DUNS number, click
on the link provided: https://iupdate.dnb.com/iUpdate/
viewiUpdateHome.htm

Provide a signature of an officer or employee of the
outsourcing facility with authority to speak on behalf of the
facility and bind it legally. Print the name and provide the
date of signature.

How can I contact the FDA if I have questions?
Email address:
[email protected]

1(h) Federal Tax ID Number: A Taxpayer Identification
Number (TIN) is an identification number used by the
Internal Revenue Service (IRS) in the administration of tax
laws. Provide the company’s federal tax ID number.

Telephone number:
1-301-796-7900
For physical mail:
Department of Health and Human Services
Food and Drug Administration
10001 New Hampshire Ave, Mail Stop 2163
Silver Spring, MD 20903

1(i) Contact Person: The contact person should be an
officer or employee of the outsourcing facility with authority
to speak on behalf of the facility and bind it legally.
1(j) Telephone Number: Provide a telephone number
(include area code). The telephone number is the number
where the contact is usually available during normal work
hours.

The information below applies only to requirements of the Paperwork Reduction Act of 1995.
The burden time for this collection of information is estimated to average 25 hours per
response, including the time to review instructions, search existing data sources, gather
and maintain the data needed and complete and review the collection of information.
Send comments regarding this burden estimate or any other aspect of this information
collection, 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
Paperwork Reduction Act (PRA) Staff
[email protected]

“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 number.”

DO NOT SEND YOUR COMPLETED FORM
TO THIS PRA STAFF EMAIL ADDRESS.

FORM FDA 3908 (7/14)

Page i

Form Instructions
PSC Publishing Services (301) 443-6740

EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. xxxx-xxxx

Outsourcing Facilities for Human Drug Compounding
Small Business Establishment Fee Reduction Request

See PRA Statement on instructions
page i.

Expiration Date: Xxxxxxx xx, 201x

Section 1. Company Information
a. Company Name
b. Address 1 (Street Address)

g. DUNS Number

c. Address 2 (Suite, unit building, floor etc.)

i. Contact Person

d. City

j. Telephone Number (Include area code)

e. State

f. ZIP Code

h. Federal Tax ID Number

k. Email Address

Section 2. Affiliate Information
List of Outsourcing Facility’s Affiliates as defined in §§ 744J(1) and 735(11) of the FD&C Act. Please include name and address of
all domestic and foreign facility affiliates, the name, phone number, and email address for a responsible point of contact for each affiliate.
Please click the provided button for additional affiliates.
Check box only if facility has NO affiliates:
Name of Affiliate
Address of Affiliate

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Point of Contact Name
Point of Contact Telephone Number (Include area code)
Point of Contact Email Address

As needed, you may click this button to add a new affiliate. This may be repeated
multiple times. Each affiliate set will consist of the 5 items shown in the first set above.

Add New Affiliate

Section 3. Total Gross Annual Sales
Gross Annual Sales (as defined in § 744J(2) of the FD&C Act) both compounding and non-compounding
related, of the entity and its affiliates for the twelve months ending April 1st of the current fiscal year.

Section 4. Signature
The data and information in this submission have been reviewed and, to the best of my knowledge, are certified to be true and accurate.
Warning: A willfully false statement is a criminal offense, U.S. Code, title 18, section 1001.
Signature

Printed Name and Position

Send Completed Form via electronic
mail (preferred) to:
[email protected]

For FDA Use Only

For physical mail:

Date Received:

Date Signed (mm/dd/yyyy)

Department of Health and Human Services
Food and Drug Administration
10001 New Hampshire Ave, Mail Stop 2163
Silver Spring, MD 20903
Approved

Denied

Privacy Act Notice: This notice is provided pursuant to the Privacy Act of 1974, 5 U.S.C. 552a. The collection of this information is authorized by
21 U.S.C. § 353b, 379j-62 and 371. FDA will use the information to assess, collect and process user fee payments, and, facilitate debt collection
under the Debt Collection Improvement Act. FDA may disclose information to courts and the Department of Justice in the context of litigation and
requests for legal advice; to other Federal agencies in response to subpoenas issued by such agencies; to HHS and FDA employees and contractors
to perform user fee services; to the National Archives and Records Administration and General Services Administration for records management
inspections; to the Department of Homeland Security and other Federal agencies and contractors in order to respond to system breaches; to banks
in order to process payment made by credit card; to Dun and Bradstreet to validate submitter contact information, and to other entities as permitted
under the Debt Collection Improvement Act. Furnishing the requested information is mandatory. Failure to supply the information could prevent FDA
from processing user fee payments. Additional detail regarding FDA’s use of information is available online: Privacy Act and Website Policies.

FORM FDA 3908 (7/14)

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PSC Publishing Services (301) 443-6740

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Outsourcing Facilities for Human Drug Compounding Small Business
Establishment Fee Reduction Request (Continued)

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FORM FDA 3908 (7/14)

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