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NOTE: On April 1, 2006, OPD will begin accepting orphan-drug and humanitarian
use device designation requests and related submissions in electronic format
only through use of physical media (e.g., CD-ROMs) as described in the guidance
document Providing Regulatory Submissions in Electronic Format – Orphan-Drug
and Humanitarian Use Device Designation Requests and Related Submissions. This
guidance is available on the FDA website at the following address:
http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0128-gdl0001.pdf
SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Providing Regulatory Submissions in Electronic Format— Orphan-Drug and Humanitarian Use Device Designation Requests and Related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.
Electronic submissions will eventually be made to OPD in one of two ways, totally electronic through the FDA Electronic Submission Gateway (ESG) pathway or directly to OPD through use of physical media (e.g., CD-ROMs). However, the ESG pathway has not been cleared to begin receiving submissions and cannot be utilized at this point in time. Instructions on each procedure and on formatting of submissions are included in the Guidance. Questions regarding electronic submissions to OPD can be made to: desigesub@fda.hhs.gov for orphan-drug designation requests or hudesub@fda.hhs.gov for HUD designation requests.
DATES: Submit written or electronic comments on the draft guidance by May 30, 2006.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ADDRESSES: Submit written requests for single copies of the draft guidance to the Electronic Submissions Coordinator, Office of Orphan Products Development (HF–35), Food and Drug Administration, 5600 Fishers Lane, rm. 6A–55,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 Submit written comments on the draft guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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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