Form 3602 A 3602 A FY 2008 MDUFMA Small Business Qualification Certificatio

OMB No. [Pending]

FY 2008 MDUFMA Foreign Small Business
Qualification Certification

Expiration Date: [Pending]

For a Business Headquartered Outside the United States

OMB Statement: See last page.

Section I — Information about the Business Requesting Small Business Status
1. Name of business requesting MDUFMA Small Business status:

2. Taxpayer Identification Num ber:

3. Address where business is physically located:

4. Name of person making this Certification:

5. Your telephone number:

Check (T) one response: G Head of Firm

G Chief Financial Officer
G Check (T) if same as item 3.

6. Your mailing address:

7. Your e-mail address:

Section II — Information about Your Affiliates
a. Name of Affiliate

b. Taxpayer ID Number

c. Gross Receipts or Sales

1.

$

2.

$

3.

$

4.

$

5.

$

6.

$

7.

$

8.

$

9.

$

10.

$

11.

Total Gross Receipts and Sales of All Affiliates (sum of lines 1 through 10)

$

12.

Gross Receipts and Sales of the Business M aking this Certification

$

13.

Total Gross Receipts and Sales Used to Determine Qualification as a Small Business
(sum of lines 11 and 12)

$

14. Have you attached a separate FY 2008 M DUFM A Foreign Small Business Qualification Certification or
a U.S. Federal income tax return for each of your affiliates?
Check (T) one response:

G Yes

G

This business has no affiliates.

15. Complete, sign, and date the following certification:
I certify that
N am e of business (m ust be identical to response to item 1)

(Check one response:)
G has no affiliates and reported “gross receipts or sales” of no more than $100,000,000 (in U.S. dollars) in its most recent tax year.
G has only the affiliates listed in this Certification, and together with those affiliates reported total “gross receipts or sales” of no more
than $100,000,000 (in U.S. dollars) in its most recent tax year.
I further certify that, to the best of my knowledge, the information I have provided in this Certification is complete and accurate. I understand
that submission of a false certification may subject me to criminal penalties under 18 U.S.C. § 1001 and other applicable federal statutes.

Signature:

Date signed:
(Signature of the person identified in item 3)

Form FDA 3602A (for FY 2008)

Section III — National Taxing Authority Certification
This Certification Must be Completed by the National Taxing Authority
1. Name of business:

2. This business is: Check (T) one response
G The business requesting small business status. (All of Section I must be completed.)
G An affiliate of a business requesting small business status. (Items 1 and 2 of Section I must be completed.)
3. Gross receipts or sales reported to the National Taxing Authority for
the most recent tax year:
Currency Unit

Amount Reported

a. Local currency:
b. U.S. currency:

4. Does the National Taxing Authority
know of any affiliate(s) of the business
requesting small business status, other
than those listed in Section II?
Check (T) one response:

U.S. Dollars

$

G No (or not applicable).
G Yes. An explanation is attached.

c. Exchange rate (per U.S. Dollar):
5. Period during which reported receipts or sales were collected:
a. Starting date:

b. Ending date:
Month-Day-Year

Month-Day-Year

6. a. Name of National Taxing Authority official making
this Certification:

7. Your telephone number:

8. Your e-mail address:
b. Your title:
9. Name of this National Taxing Authority:

10. Sign and date the following certification:

Affix O fficial Seal of N ational Taxing Authority here:

I certify that, to the best of my knowledge, the information I have
provided in this Certification is complete and accurate.

Signature of official making this Certification (must be signed by the official identified in item 5)

Date of this Certification:
The business seeking sm all business status should m ail its com pleted FY 2008 Sm all
Business Q ualification C ertification to FDA at the address below . Your
C ertification is not com plete and w ill not be accepted unless Section III has been
com pleted by your N ational Taxing Authority. If your business has any affiliates, you
m ust also send a separate FY 2008 Sm all Business Q ualification C ertification or U .S.
Federal incom e tax return for each affiliate. Send all m aterials to —
FY 2008 Sm all Business Q ualification (H FZ-222)
D ivision of Sm all M anufacturers, International, and C onsum er A ssistance
U .S. Food and D rug Adm inistration
1350 Piccard D r.
Rockville, M D 20850
U nited States of A m erica
O M B Statem ent. T he pub lic reporting burden for this collection of inform ation is estim ated
to average 1 hour per response, including the tim e for reviewing instructions, searching existing
data sources, gathering and m aintaining the data needed, and com pleting and reviewing the
collection of inform ation. Send com m ents regarding this burden estim ate or another aspect of
this collection of inform ation, including suggestions for reducing this burd en to:

(U .S. FDA U se O nly)
Review:

G C ertification is com plete.
G Inform ation not com plete.

D ecision:

G Q ualifies for Sm all Business fee discounts.
G Q ualifies for Sm all Business fee discounts
and fee w aiver for first prem arket application.

SBD 08
G D oes not qualify.

U .S. Food and D rug Adm inistration
Form s C om m ents, H FZ-20
2098 G aither Road
Rockville, M D 20850
U nited States of A m erica

A n agency m ay not conduct or sponsor, and
a person is not required to respond to, a
collection of inform ation unless it displays a
currently valid O ffice of M anagem ent and
Budget (O M B) control num ber.