Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; 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 the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

DATES:

Submit written comments on the collection of information by November 10, 2003.

ADDRESSES:

OMB is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. 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: Fumie Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT:

Peggy Robbins, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

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.

MDUFMA Small Business Qualification Certification (Form FDA 3602)—(OMB Control Number 0910-0508)—Extension

Medical Device User Fee and Modernization Act (MDUFMA) amends the Federal Food, Drug, and Cosmetic Act to provide for user fees for certain medical device applications. The initial fees (for fiscal year (FY) 2003) are set by statute; FDA will publish a Federal Register notice by August 1, 2003, announcing the fees for FY 2004. 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.

Presently, a “small business” is an applicant who reported no more than $30 million “gross receipts or sales” on its Federal income tax return for the most recent tax year; the applicant must count the “gross receipts or sales” of all of its affiliates, partners, or parent firms when calculating whether it meets the $30 million threshold. 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 will be available in a forthcoming guidance document, “MDUFMA Small Business Qualification Worksheet and Certification.” This guidance will describe 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 2004 and subsequent fiscal years. FDA will publish this guidance by August 1, 2003.

Respondents will be businesses or other for-profit organizations.

In the Federal Register of July 18, 2003 (68 FR 42742), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received.

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

FDA based these estimates on conversations with industry, trade association representatives, and from internal FDA estimates. This represents FDA's estimate on the number of small businesses that will submit a premarket notification, a premarket application, a premarket report, a panel track supplement, efficacy supplement, 180-day supplement, or a real time supplement to FDA during a single fiscal year from FY 2004 through 2007.