Federal Register / Vol. 77, No. 75 / Wednesday, April 18, 2012 / Notices 23267 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total 

burden 

hours 

Youth Outcome Survey ................................................................... 15,334 1 0.50 7,667 

Data File .......................................................................................... 52 2 1,201 124,904 

Estimated Total Annual Burden 

Hours: 132,571. 

In compliance with the requirements 

of Section 506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 370 L’Enfant 

Promenade, SW., Washington, DC 

20447, Attn: ACF Reports Clearance 

Officer. Email address: 

infocollection@acf.hhs.gov. All requests 

should be identified by the title of the 

information collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2012–9337 Filed 4–17–12; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0324] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance for 

Industry, FDA Staff, and Foreign 

Governments: Fiscal Year 2012 

Medical Device User Fee Small 

Business Qualification and 

Certification 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

Form FDA 3602 and Form FDA 3602A, 

which will allow domestic and foreign 

applicants to certify that they qualify as 

a ‘‘small business’’ and pay certain 

medical device user fees at reduced 

rates. 

DATES: Submit either electronic or 

written comments on the collection of 

information by June 18, 2012. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://www.regulations.

gov. Submit written comments on the 

collection of information to the Division 

of Dockets Management (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852. All comments should be 

identified with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, Daniel.Gittleson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Guidance for Industry, FDA Staff, and 

Foreign Governments: Fiscal Year 2012 

Medical Device User Fee Small 

Business Qualification and 

Certification—(OMB Control Number 

0910–0508)—Extension 

Section 101 of the Medical Device 

User Fee and Modernization Act 

(MDUFMA) amends the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act) 

to provide for user fees for certain 

medical device applications. FDA 

mstockstill on DSK4VPTVN1PROD with NOTICES

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