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Notice

Guidance for Industry on How To Write a Request for Designation; Availability

Action

Notice.

Summary

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled “How to Write a Request for Designation (RFD).” This guidance is intended to clarify the type of information the Office of Combination Products (OCP) recommends that a sponsor include in a Request for Designation (RFD). This final guidance supersedes the previous RFD guidance document issued August 2005.

 

Table of Contents Back to Top

DATES: Back to Top

Submit either electronic or written comments on Agency guidances at any time.

ADDRESSES: Back to Top

Submit written requests for single copies of this guidance to the Office of Combination Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5129, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Back to Top

Kristina Lauritsen, Office of Combination Products, Food and Drug Administration, Bldg. 32, rm. 5132, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-8936.

SUPPLEMENTARY INFORMATION: Back to Top

I. Background Back to Top

FDA is announcing the availability of a guidance for industry entitled “How to Write a Request for Designation (RFD).” This guidance addresses 21 CFR 3.7 and is intended to clarify the type of information OCP recommends that a sponsor include in an RFD. The goal of this guidance is to help a sponsor understand what information FDA needs to determine the regulatory identity or classification of a product as a drug, device, biological product, or combination product, and to assign the product to the appropriate Agency component for review and regulation. This final guidance supersedes the previously issued RFD guidance document which was published on FDA's Web site on August 2005.

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 how to write an RFD. 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 statutes and regulations.

II. Paperwork Reduction Act of 1995 Back to Top

This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 3 have been approved under OMB control number 0910-0523.

III. Comments Back to Top

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments 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.

IV. Electronic Access Back to Top

Persons with access to the Internet may obtain the document at either http://www.fda.gov/RegulatoryInformation/Guidances/ucm122047.htm or http://www.regulations.gov.

Dated: April 11, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.

[FR Doc. 2011-9261 Filed 4-15-11; 8:45 am]

BILLING CODE 4160-01-P

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