E6-19285. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Medical Device User Fee and Modernization Act Small Business Qualification Certification (Form FDA 3602)

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

DATES:

Fax written comments on the collection of information by December 15, 2006.

ADDRESSES:

To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: [phone].

FOR FURTHER INFORMATION CONTACT:

Denver Presley, Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472.

SUPPLEMENTARY INFORMATION:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Medical Device User Fee and Modernization Act Small Business Qualification Certification (Form FDA 3602)—(OMB Control Number 0910-0508)—Extension

The Medical Device User Fee and Modernization Act (MDUFMA) small business qualification certification form (Form FDA 3602), amends the Federal Food, Drug, and Cosmetic Act to provide for user fees for certain medical device applications. FDA published a Federal Register notice on August 2, 2006 (71 FR 43784), announcing fees for fiscal year (FY) 2007. 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.

For FY 2006, 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 (PMA, product development protocol (PDP), biologics license application (BLA), 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. 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.

Form FDA 3602 is available in the guidance document entitled “Guidance for Industry and FDA: FY 2006 MDUFMA Small Business Qualification Worksheet and Certification.” 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 2006 and subsequent fiscal years.

In the Federal Register of August 29, 2006 (71 FR 51196), FDA published a 60-day notice soliciting comments on the information collection provisions. In response to that notice, no comments were received.

Description of Respondents: Respondents will be businesses or other for-profit organizations.

FDA estimates the burden of this collection of information as follows:

Table 1.—Estimated Annual Reporting Burden¹

FDA Form Number	No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Response	Total Hours
3602	2,000	1	2,000	1	2,000
Total					2,000
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The burden is based on the number of applications received in the last 3 years.

Dated: November 9, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.