[Federal Register Volume 71, Number 62 (Friday, March 31, 2006)]
[Notices]
[Pages 16317-16318]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-4709]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0128]


Draft Guidance for Industry on Providing Regulatory Submissions 
in Electronic Format--Orphan-Drug and Humanitarian Use Device 
Designation Requests and Related Submissions; Availability

AGENCY: Food and Drug Administration, HHS.

[[Page 16318]]


ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Providing 
Regulatory Submissions in Electronic Format--Orphan-Drug and 
Humanitarian Use Device Designation Requests and Related Submissions.'' 
This is one in a series of guidance documents on providing regulatory 
submissions to FDA in electronic format. This guidance discusses issues 
related to the electronic submission of orphan-drug and humanitarian 
use device (HUD) designation requests and related submissions to the 
Office of Orphan Products Development (OPD). The submission of these 
documents in electronic format should improve the agency's efficiency 
in processing, archiving, and reviewing them.

DATES: Submit written or electronic comments on the draft guidance by 
May 30, 2006. General comments on agency guidance documents are welcome 
at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Electronic Submissions Coordinator, Office of Orphan 
Products Development (HF-35), Food and Drug Administration, 5600 
Fishers Lane, rm. 6A-55, Rockville, MD 20857. Send one self-addressed 
adhesive label to assist that office in processing your requests. 
Submit written comments on the draft guidance to the Division of 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INFORMATION section for electronic access to the draft guidance 
document.

FOR FURTHER INFORMATION CONTACT: James D. Bona, Office of Orphan 
Products Development (HF-35), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-3666.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Providing Regulatory Submissions in Electronic Format--
Orphan-Drug and Humanitarian Use Device Designation Requests and 
Related Submissions.'' This draft document provides guidance to 
industry regarding submissions of designation requests and related 
submissions to OPD in electronic format. It describes the two methods 
by which submissions can be made electronically to OPD. The first is 
totally electronic through use of FDA's electronic submission gateway 
pathway and the second is directly to OPD through the use of physical 
media (e.g., CD-ROMs). Recommendations are described for the formatting 
and organization of these submissions. A listing of agency contacts for 
assistance is also provided.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on providing 
designation requests and related submissions in electronic format. 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. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the draft guidance. 
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. The draft guidance and received 
comments may be seen in the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.

III. Paperwork Reduction Act of 1995

    This notice contains no new collections of information. The 
information requested for designation requests and related submissions 
is already covered by the regulations for orphan-drugs under 21 CFR 
316.20 and for HUDs under 21 CFR 814.102. This notice announces the 
availability of a guidance that provides applicants with an alternative 
mechanism for submitting designation requests and related submissions 
to the agency. Therefore, clearance by the Office of Management and 
Budget under the Paperwork Reduction Act of 1995 is not required.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/orphan/esub/esub.htm or at http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: March 24, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-4709 Filed 3-30-06; 8:45 am]
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