07-5226. Guidance for Industry, Food and Drug Administration, and Foreign Governments; Fiscal Year 2008 Medical Device User Fee Small Business Qualification and Certification; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled “FY 2008 Medical Device User Fee Small Business Qualification and Certification.” This guidance explains how a business headquartered in the United States or headquartered in a foreign nation may respectively qualify as “small business” under the medical device user fee provisions of the Federal Food, Drug, and Cosmetic Act (the act). A “small business” may pay certain medical device user fees at a substantial discount from the standard (full) fee rates and may obtain a one-time fee waiver for its first premarket application (a premarket approval application (PMA), biologics license application (BLA), product development protocol (PDP), or premarket report (PMR)).

DATES:

Submit written or electronic comments on this guidance at any time. General comments on agency guidance documents are welcome at any time.

ADDRESSES:

Submit written requests for single copies of the guidance document entitled “FY 2008 Medical Device User Fee Small Business Qualification and Certification” to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 240-276-3151. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance.

Submit written comments concerning this guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/​dockets/​ecomments or http://www.regulations.gov. Identify comments with the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Joseph V. Puleo, Center for Devices and Radiological Health (HFZ-220), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3150, ext. 116, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

“FY 2008 Medical Device User Fee Small Business Qualification and Certification” explains how a business headquartered in the United States or headquartered in a foreign nation may qualify as “small business” under the medical device user fee provisions of the act (21 U.S.C. 301). A “small business” may pay certain medical device user fees at a substantial discount from the standard (full) fee rates and may obtain a one-time fee waiver for its first premarket application (a PMA, BLA, PDP, or PMR). The following fees apply for fiscal year (FY) 2008:

Application Type	FY 2008
	Standard Fee	Small Business
Premarket application (PMA, BLA, PDP, or PMR)	$185,000	$46,250
Panel-track PMA supplement	$138,750	$34,688
BLA efficacy supplement	$185,000	$46,250
180-day PMA supplement	$27,750	$6,938
Real-time PMA supplement	$12,950	$3,238
510(k) premarket notification	$3,404	$1,702
30-day notice	$2,960	$1,480
513(g) request	$2,498	$1,249
Periodic reporting on a class III device	$6,475	$1,619
Establishment registration	$1,706

To qualify as a “small business,” the business must have “gross receipts or sales” of no more than $100 million in the most-recent tax year, including the “gross receipts or sales” of all of the business' affiliates (see sections 738(d)(2)(A) and (e)(2)(A) of the act (21 U.S.C. 379j(d)(2)(A) and (e)(2)(A))). An affiliate is defined by section 737(12) of the act (21 U.S.C. 379i(12)) as a business entity that has a relationship with a second business entity if, directly or indirectly—

“(A) one business entity controls, or has the power to control, the other business entity; or

(B) a third party controls, or has power to control, both of the business entities.”

A business headquartered in the United States must demonstrate that it meets the $100 million threshold by submitting a certified copy of its most-recent Federal (U.S.) income tax return. A business headquartered outside the United States must demonstrate that it meets the $100 million threshold by submitting a National Taxing Authority Certification from the foreign equivalent of the U.S. Internal Revenue Service. Under the guidance, both U.S. and foreign businesses should provide FDA with contact information, identify all of their affiliates, and certify that the information they provide to FDA is complete and accurate.

FDA is making this final guidance document immediately available. Prior public participation is not feasible because it implements statutory requirements that require immediate implementation. This guidance is necessary to help effect such implementation.

II. Significance of Guidance

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on FY 2008 medical device user fee small business qualification and certification. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.

III. Electronic Access

To receive “FY 2008 Medical Device User Fee Small Business Qualification and Certification,” you may either send an e-mail request to [e-mail] to receive an electronic copy of the document or send a fax request to 240-276-3151 to receive a hard copy. Please use the document number 2008 to identify the guidance you are requesting.

Persons interested in obtaining a copy of the guidance may do so by using the Internet. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, Federal Register reprints, information on premarket submissions (including lists of approved applications and manufacturers' addresses), small manufacturer's assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH Web site may be accessed at http://www.fda.gov/​cdrh. A search capability for all CDRH guidance documents is available at http://www.fda.gov/​cdrh/​guidance.html. Guidance documents are also available on the Division of Dockets Management Internet site at http://www.fda.gov/​ohrms/​dockets.

IV. Paperwork Reduction Act of 1995

This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 USC 3501-3520). The collections of information in this guidance were approved under OMB control number 0910-0613 (approval expires April 16, 2008).

This guidance also refers to previously approved collections of information found in FDA regulations. The collections of information in Form FDA 3602 have been approved under OMB Control No. 0910-0508 (approval expires January 31, 2010).

V. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Dated: October 18, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.