05-7947. Guidance for Industry and Food and Drug Administration Staff on Application User Fees for Combination Products; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry and FDA staff entitled “Application User Fees for Combination Products.” This document provides guidance to industry and FDA staff on marketing application user fees for combination products. The guidance also describes how the “barrier to innovation” waiver provision under the prescription drug user fee provisions of the Federal Food, Drug, and Cosmetic Act (the act) may be applied to innovative combination products in the infrequent situation where FDA requires the submission of two marketing applications.

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 copies of this guidance to the Office of Combination Products (HFG-3), 15800 Crabbs Branch Way, Rockville, MD 20855, or FAX: [phone]. Send one self-addressed adhesive label to assist that office in processing your requests. 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. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:

Mark D. Kramer, Office of Combination Products (HFG-3), Food and Drug Administration, 15800 Crabbs Branch Way, Rockville, MD 20855, 301-427-1934.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a guidance for industry and FDA staff entitled “Application User Fees for Combination Products.” In the Federal Register of September 28, 2004 (69 FR 57942), FDA issued a notice of availability of a draft guidance document covering the same topic.

As defined under 21 CFR 3.2(e), a combination product is a product comprised of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product. Depending upon the type of combination product, approval, clearance, or licensure may be obtained through submission of a single marketing application, or through separate marketing applications for the individual constituent parts of the combination product. For most combination products, a single marketing application is sufficient for the product's approval, clearance, or licensure. In some cases, two marketing applications may be submitted for a combination product when one application would suffice. For example, a sponsor may choose to submit two applications when one would suffice in order to receive some benefit from having two applications. In other cases, FDA may determine that two marketing applications are necessary.

In 1992, Congress passed the Prescription Drug User Fee Act (PDUFA). PDUFA authorized FDA to collect fees from companies that produce certain human drug and biological products. The Medical Device User Fee and Modernization Act of 2002 amended the act to provide for user fees for the review of device applications. When a company requests approval of a new drug, device, or biological product prior to marketing, it must submit an application along with a fee to support the review process.

This document provides guidance to industry and FDA staff on marketing application user fees for combination products. The guidance document explains that combination products for which a single marketing application is submitted, should be assessed the user fee associated with that particular type of marketing application. The document explains that if a sponsor chooses to submit two marketing applications when one would suffice, a user fee for each application would ordinarily be assessed. The document also explains that in the infrequent situation where FDA requires two marketing applications for a combination product, two application fees would ordinarily be assessed. However, the guidance also describes how the PDUFA “barrier to innovation” waiver provision may be applied to innovative combination products for which FDA requires the submission of two marketing applications. Such a waiver would provide a reduction in application user fees equivalent to the additional fee burden associated with the submission of two marketing applications. This guidance does not address how FDA should determine whether a single or multiple marketing applications should be submitted for a combination product. Such guidance is in development and will be provided separately for public review and comment.

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 application user fees for combination products. 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. Comments

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

IV. Electronic Access

Persons with access to the Internet may obtain the document at http://www.fda.gov/​oc/​combination or by e-mailing the Office of Combination Products at [e-mail]. Guidance documents are also available on the Division of Dockets Management Internet site at http://www.fda.gov/​ohrms/​dockets/​default.htm.

Dated: April 15, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.