[Federal Register: March 31, 2006 (Volume 71, Number 62)]
[Notices]
[Page 16317-16318]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31mr06-76]
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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Draft Guidance for Industry on Providing Regulatory Submissions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availability of a draft guidance for industry entitled ``Providing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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Electronic Submissions Coordinator, Office of Orphan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Submit written comments on the draft guidance to the Division of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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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INFORMATION section for electronic access to the draft guidance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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/orphan/esub/esub.htm or at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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]
BILLING CODE 4160-01-S