Document ID: FDA-2011-D-0214-0001
Agency: fda
Document Type: Notice
Title: Guidance for Industry on How to Write a Request for Designation; Availability
Posted Date: 2011-04-18T04:00Z

[Federal Register Volume 76, Number 74 (Monday, April 18, 2011)]
[Notices]
[Pages 21752-21753]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-9261]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0214]

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

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

ADDRESSES: 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: 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:

I. Background

    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

    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.

[[Page 21753]]

III. Comments

    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

    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