23268 Federal Register / Vol. 77, No. 75 / Wednesday, April 18, 2012 / Notices 

published a Federal Register notice on 

August 1, 2011 (76 FR 45826), 

announcing fees for fiscal year (FY) 

2012. To avoid harming small 

businesses, MDUFMA provides for 

reduced or waived fees for applicants 

who qualify as a ‘‘small business.’’ This 

means there are two levels of fees, a 

standard fee and a reduced or waived 

small business fee. You can qualify for 

a small business fee discount under 

MDUFMA if you reported gross receipts 

or sales of no more than $100 million 

on your Federal income tax return for 

the most recent tax year. If you have any 

affiliates, partners, or parent firms, you 

must add their gross receipts or sales to 

yours, and the total must be no more 

than $100 million. If your gross receipts 

or sales are no more than $30 million, 

including all of your affiliates, partners, 

and parent firms, you will also qualify 

for a waiver of the fee for your first 

(ever) premarket application (product 

development protocol, biologics 

licensing application, or premarket 

report). An applicant must pay the full 

standard fee unless it provides evidence 

demonstrating to FDA that it meets the 

‘‘small business’’ criteria (Form FDA 

3602, ‘‘FY 2012 MDUFMA Small 

Business Qualification Certification— 

For A Business Headquartered in the 

United States’’). The evidence required 

by MDUFMA is a copy of the most 

recent Federal income tax return of the 

applicant, and any affiliate, partner, or 

parent firm. FDA will review these 

materials and decide whether an 

applicant is a ‘‘small business’’ within 

the meaning of MDUFMA. 

The 2007 Amendments provide an 

alternative way for a foreign business to 

qualify as a small business eligible to 

pay a significantly lower fee when a 

medical device user fee must be paid 

(Form FDA 3602A, ‘‘FY 2012 MDUFMA 

Foreign Small Business Qualification 

Certification—For a Business 

Headquartered Outside the United 

States’’). Before passage of the 2007 

Amendments, the only way a business 

could qualify as a small business was to 

submit a Federal (U.S.) income tax 

return showing its gross receipts or sales 

that did not exceed a statutory 

threshold, currently, $100 million. If a 

business could not provide a Federal 

income tax return, it did not qualify as 

a small business and had to pay the 

standard (full) fee. Because many 

foreign businesses have not, and cannot, 

file a Federal (U.S.) income tax return, 

this requirement has effectively 

prevented those businesses from 

qualifying for the small business fee 

rates. Thus, foreign governments, 

including the European Union, have 

objected. In lieu of a Federal income tax 

return, the 2007 Amendments will 

allow a foreign business to qualify as a 

small business by submitting a 

certification from its national taxing 

authority, the foreign equivalent of our 

Internal Revenue Service. This 

certification, referred to as a ‘‘National 

Taxing Authority Certification,’’ must: 

Be in English; be from the national 

taxing authority of the country in which 

the business is headquartered; provide 

the business’ gross receipts or sales for 

the most recent year, in both the local 

currency and in U.S. dollars, and the 

exchange rate used in converting local 

currency to U.S. dollars; provide the 

dates during which the reported receipts 

or sales were collected; and bear the 

official seal of the national taxing 

authority. 

Both Forms FDA 3602 and FDA 

3602A are available in the guidance 

document, ‘‘Guidance for Industry, 

Food and Drug Administration Staff, 

and Foreign Governments: FY 2012 

Medical Device User Fee Small Business 

Qualification and Certification,’’ 

available on the Internet at: http://www.

fda.gov/downloads/MedicalDevices/

DeviceRegulationandGuidance/

Overview/MedicalDeviceUserFeeand

ModernizationActMDUFMA/

UCM267051.pdf. This guidance 

describes the criteria FDA will use to 

decide whether an entity qualifies as a 

MDUFMA small business and will help 

prospective applicants understand what 

they need to do to meet the small 

business criteria for FY 2012. 

The Form FDA 3602 burden is based 

on the number of applications received 

in the last 3 years. FDA believes most 

entities that submit Form FDA 3602A 

will not have any affiliates, and very 

few will have more than three or four 

affiliates. Based on our experience with 

Form FDA 3602A, FDA believes each 

business will require 1 hour to complete 

the form. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

FDA Form No. Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden 

per response 

Total hours 

3602 ................................................................. 4,200 1 4,200 1 4,200 

3602A ............................................................... 900 1 900 1 900 

Total .......................................................... ............................ ............................ ............................ ............................ 5,100 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: April 10, 2012. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2012–9241 Filed 4–17–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2005–E–0310 (previously 

FDA Docket No. 2005E–0245)] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; KEPIVANCE; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice that appeared in the Federal 

Register of April 2, 2007 (72 FR 15699). 

The document concerned FDA’s 

determination of the regulatory review 

period for KEPIVANCE. The document 

cited an incorrect statute under which 

the KEPIVANCE biologics license 

application was submitted. This 

document corrects the citation. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 77, No. 75 / Wednesday, April 18, 2012 / Notices 23269 

10903 New Hampshire Ave., Bldg. 51, 

Rm. 6222, Silver Spring, MD 20993– 

0002, 301–796–3602. 

SUPPLEMENTARY INFORMATION: In FR Doc. 

2007–15699 on page 15700 in the 

Federal Register of Monday, April 2, 

2007, the following correction is made: 

1. On page 15700, in the first column, 

in the first line, ‘‘505(b) of the act’’ is 

corrected to read ‘‘351 of the Public 

Health Service Act (42 U.S.C. 262).’’ 

Dated: February 28, 2012. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. 2012–9325 Filed 4–17–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–P–0888] 

Determination That FUNDUSCEIN-25 

(fluorescein sodium injection), 25%, 

and AK-FLUOR (fluorescein sodium 

injection), 25%, Were Not Withdrawn 

From Sale for Reasons of Safety or 

Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

that FUNDUSCEIN-25 (fluorescein 

sodium injection), 25%, and AK-FLUOR 

(fluorescein sodium injection), 25%, 

were not withdrawn from sale for 

reasons of safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for fluorescein 

sodium injection, 25%, if all other legal 

and regulatory requirements are met. 

FOR FURTHER INFORMATION CONTACT: Jane 

Inglese, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave. Bldg. 51, Rm. 6210, Silver Spring, 

MD 20993–0002, 301–796–3601. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products under an 

ANDA procedure. ANDA applicants 

must, with certain exceptions, show that 

the drug for which they are seeking 

approval contains the same active 

ingredient in the same strength and 

dosage form as the ‘‘listed drug,’’ which 

is a version of the drug that was 

previously approved. ANDA applicants 

do not have to repeat the extensive 

clinical testing otherwise necessary to 

gain approval of a new drug application 

(NDA). The only clinical data required 

in an ANDA are data to show that the 

drug that is the subject of the ANDA is 

bioequivalent to the listed drug. 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which requires FDA to 

publish a list of all approved drugs. 

FDA publishes this list as part of the 

‘‘Approved Drug Products With 

Therapeutic Equivalence Evaluations,’’ 

which is known generally as the 

‘‘Orange Book.’’ Under FDA regulations, 

drugs are removed from the list if the 

Agency withdraws or suspends 

approval of the drug’s NDA or ANDA 

for reasons of safety or effectiveness or 

if FDA determines that the listed drug 

was withdrawn from sale for reasons of 

safety or effectiveness (21 CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug ((21 CFR 314.161). FDA may 

not approve an ANDA that does not 

refer to a listed drug. 

FUNDUSCEIN-25 (fluorescein sodium 

injection), 25%, is the subject of NDA 

17-869, held by Novartis 

Pharmaceuticals Corp., and initially 

approved on November 10, 1976. 

FUNDUSCEIN-25 is indicated for use in 

diagnostic fluorescein angiography or 

angioscopy of the retina and iris 

vasculature. AK-FLUOR (fluorescein 

sodium injection), 25%, is the subject of 

NDA 22-186, held by Akorn Inc., and 

initially approved on August 8, 2008. 

AK-FLUOR also is indicated for use in 

diagnostic fluorescein angiography or 

angioscopy of the retina and iris 

vasculature. 

FUNDUSCEIN-25 (fluorescein sodium 

injection), 25%, and AK-FLUOR 

(fluorescein sodium injection), 25%, are 

currently listed in the ‘‘Discontinued 

Drug Product List’’ section of the Orange 

Book. 

Foley & Lardner LLP submitted a 

citizen petition dated December 7, 2011 

(Docket No. FDA–2011–P–0888), under 

21 CFR 10.30, requesting that the 

Agency determine whether 

FUNDUSCEIN-25 (fluorescein sodium 

injection), 25%, was withdrawn from 

sale for reasons of safety or 

effectiveness. Although the citizen 

petition did not address AK-FLUOR 

(fluorescein sodium injection), 25%, 

that product has also been discontinued. 

On our own initiative, we have therefore 

also determined whether AK-FLUOR 

was withdrawn for safety or 

effectiveness reasons. 

After considering the citizen petition 

and reviewing Agency records, and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that FUNDUSCEIN-25 

(fluorescein sodium injection), 25%, 

and AK-FLUOR (fluorescein sodium 

injection), 25%, were not withdrawn for 

reasons of safety or effectiveness. The 

petitioner has identified no data or other 

information suggesting that 

FUNDUSCEIN-25 (fluorescein sodium 

injection), 25%, was withdrawn for 

reasons of safety or effectiveness. We 

have carefully reviewed our files for 

records concerning the withdrawal of 

FUNDUSCEIN-25 (fluorescein sodium 

injection), 25%, and AK-FLUOR 

(fluorescein sodium injection), 25%, 

from sale. We have also independently 

evaluated relevant literature and data 

for possible postmarketing adverse 

events. We have reviewed the available 

evidence and determined that 

FUNDUSCEIN-25 (fluorescein sodium 

injection), 25%, and AK-FLUOR 

(fluorescein sodium injection), 25%, 

were not withdrawn from sale for 

reasons of safety or effectiveness. 

Accordingly, the Agency will 

continue to list FUNDUSCEIN-25 

(fluorescein sodium injection), 25%, 

and AK-FLUOR (fluorescein sodium 

injection), 25%, in the ‘‘Discontinued 

Drug Product List’’ section of the Orange 

Book. The ‘‘Discontinued Drug Product 

List’’ delineates, among other items, 

drug products that have been 

discontinued from marketing for reasons 

other than safety or effectiveness. 

ANDAs that refer to FUNDUSCEIN-25 

(fluorescein sodium injection), 25%, or 

AK-FLUOR (fluorescein sodium 

injection), 25%, may be approved by the 

Agency as long as they meet all other 

legal and regulatory requirements for 

the approval of ANDAs. If FDA 

determines that labeling for this drug 

product should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: April 11, 2012. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2012–9292 Filed 4–17–12; 8:45 am] 

BILLING CODE 4160–01–P 

mstockstill on DSK4VPTVN1PROD with NOTICES