[Federal Register Volume 65, Number 251 (Friday, December 29, 2000)]
[Notices]
[Pages 83069-83070]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-33370]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

RIN 00N-1686


Electronic Investigational New Drug Application: Cumulative Table 
of Contents; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting to discuss the possibility of using extensible markup language 
(XML) to create a cumulative table of contents for investigational new 
drug applications (IND's) intended to be submitted electronically to 
the Center for Biologics Evaluation and Research (CBER) or the Center 
for Drug Evaluation and Research (CDER). Although the agency does not 
yet have a comprehensive approach to accepting IND's in electronic 
format in place of paper, it is updating existing guidance to make 
electronically submitted IND's in place of paper possible in the 
future. The agency is hoping to gain public input at the meeting on the 
use of XML to create a cumulative table of contents.

DATES: The public meeting will be held on January 26, 2001, from 8 a.m. 
to 4 p.m. Submit registration request by January 17, 2001. Written 
comments on the use of XML to create a cumulative table of contents are 
welcome at any time.

ADDRESSES: The public meeting will be held in the CDER Advisory 
Committee Conference Room, 5630 Fishers Lane, rm. 1066, Rockville, MD 
20852.

FOR FURTHER INFORMATION CONTACT: Randy Levin, Center for Drug 
Evaluation and Research (HFD-001), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5400, e-mail: 
[email protected], or Robert A. Yetter, Center for Biologics 
Evaluation and Research (HFM-025), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852, 301-827-0373, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: FDA is holding a public meeting to discuss 
the possibility of using XML to create a cumulative table of contents 
for IND's intended to be submitted electronically to CBER or CDER. The 
agency is updating guidance to make electronically submitted IND's in 
place of paper possible in the future. The agency is interested in 
input from the public on the following questions related to the use of 
XML to create a cumulative table of contents:
     Would a cumulative table of contents offer you advantages?
     How difficult is it for you to create and maintain the XML 
files needed for the cumulative table of contents?
     How difficult will it be for you to incorporate the 
preparation of an XML document in your submission preparation process?
     Do you have suggestions for improvements on the cumulative 
table of contents?
     Are you interested in piloting the cumulative table of 
contents in electronic IND's with the agency?
     Are you interested in working with us to develop tools to 
be used with the cumulative table of contents?
     Do you have other comments or suggestions?
    An agenda and other materials including an example of a cumulative 
table of contents will be available prior to the meeting on the 
Internet at 
http://www.fda.gov/cder/regulatory/ersr/default.htm. Although there is 
no fee, preregistration by January 17, 2001, is required for all 
attendees at this meeting. Participation is limited to the first 100 
registrants. To accommodate the greatest number of interested parties, 
registration is limited to persons outside FDA, and no more than two 
persons from an individual company should attend. Persons interested in 
attending the meeting should register by sending the names of those 
attending with the name of their company in an e-mail message to 
[email protected].
    The location of the meeting is 5630 Fishers Lane, next to the 
Parklawn Bldg. Please use the lower entrance, which faces Parklawn Dr. 
Visitor badges will be held at the guard station at the entrance to the 
building. Participants will need picture identifications to pick up 
their badge. Public parking is not available at the 5630 Fishers Lane 
location. A public parking lot is available on Fishers Lane across from 
the Parklawn Bldg., and additional public parking is available at the

[[Page 83070]]

Twinbrook Metro Station located several blocks west of the meeting 
location.
    Interested persons may submit to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, written comments on the use of XML to create a 
cumulative table of contents. Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. Comments are available for public examination in the 
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

    Dated: December 22, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-33370 Filed 12-28-00; 8:45 am]
BILLING CODE 4160-01-F