[Federal Register Volume 71, Number 224 (Tuesday, November 21, 2006)]
[Notices]
[Pages 67356-67359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-9313]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0464]


Electronic Submission of Regulatory Information, and Creating an 
Electronic Platform for Enhanced Information Management; Public Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public hearing; request for comment.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
hearing to solicit general views and information from interested 
persons on issues concerning the electronic submission of product 
information to the agency. In particular, FDA is seeking these views 
and information from interested persons on the feasibility and effect 
of an all-electronic submission environment, as well as issues related 
to an electronic regulatory information exchange platform. To help 
solicit such information and views, FDA is seeking responses to 
specific questions (see section IV of this document).

DATES: Public Hearing: The public hearing will be held on December 18, 
2006, from 9 a.m. to 5 p.m. However, depending on the level of public 
participation, the meeting may be extended or may end early.
    Registration and Participation: Registration on the day of the 
public hearing will be provided on a space available basis beginning at 
7:30 a.m. Because seating is limited, we recommend arriving early. See 
section I of the SUPPLEMENTARY INFORMATION section of this document for 
information on how to participate in the meeting. If you need special 
accommodations due to a disability, please contact Paula S. McKeever 
(see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance.
    Comments: Submit written or electronic notices of participation and 
comments by December 8, 2006. The administrative record of the hearing 
will remain open to receive additional comments until February 16, 
2007.

ADDRESSES:  The public hearing will be held at the Advisors and 
Consultants Staff Conference Room, Food and Drug Administration, 5630 
Fishers Lane, Rockville, MD 20857. Additional information on parking 
and public transportation may be accessed at http://www.fda.gov/oc/initiatives/criticalpath/ criticalpath/.
    Submit written notices of participation and comments to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20857. Submit electronic 
notices of participation and comments to http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm. Identify all submissions 
to the docket with the docket number found in brackets in the heading 
of this document.

FOR FURTHER INFORMATION CONTACT: Paula S. McKeever, Office of Critical 
Path Programs (HF-18), Food and Drug Administration, 5600 Fishers Lane, 
rm. 14B-45, Rockville, MD 20857, 301-827-1520, 
[email protected].

SUPPLEMENTARY INFORMATION:

[[Page 67357]]

I. How to Participate in the Meeting

    The procedures governing the hearing are set forth in part 15 (21 
CFR part 15) of FDA's regulations. If you wish to make an oral 
presentation during the hearing, you must submit a written notice of 
participation with the Division of Dockets Management (see ADDRESSES) 
by December 8, 2006. In the written notice, submit your name, title, 
business affiliation, address, telephone number, fax number, and e-mail 
address. You should also submit a written statement for each discussion 
topic in section IV of this document that you intend to address, or 
other pertinent information related to the topic in your presentation, 
the names and addresses of all individuals that plan to participate, 
and the approximate time requested for your presentation. We encourage 
individuals and organizations with common interests to consolidate or 
coordinate their presentations to allow adequate time for each request 
for presentation. Participants should submit to the docket two copies 
of each presentation.
    We will file the hearing schedule indicating the order of 
presentation and the time allotted to each person with the Division of 
Dockets Management (see ADDRESSES). We will also mail or telephone the 
schedule to each participant before the hearing. In anticipation of the 
hearing presentations moving ahead of schedule, participants are 
encouraged to arrive early to ensure their designated order of 
presentation. Participants who are not present when called, risk 
forfeiting their scheduled time.

II. Background

    Over the past decade, we have been moving toward transforming all 
regulatory submissions from paper to electronic means. To meet this 
goal, we have taken the following steps:
     Issued regulations related to voluntary electronic 
submission of regulatory information and provided a docket listing all 
submissions that we accept electronically (e.g., electronic records and 
electronic signatures, 21 CFR part 11; docket 92S-0251; http://www.fda.gov/ohrms/dockets/dockets/92s0251/92s0251.htm);
     Issued regulations requiring or proposing to require 
electronic submission of certain regulatory information (e.g., the 
electronic submission of the content of labeling (December 11, 2003; 68 
FR 69009), and manufacturer registration and listing of drug products 
(August 29, 2006; 71 FR 51275));
     Issued numerous guidance documents to assist in the 
submission of various regulatory documents in electronic format (e.g., 
electronic common technical document, certain premarket applications, 
and postmarketing information; see http://www.fda.gov/cder/guidance/index.htm#electronic%20submissions);
     Issued notices related to electronic submission (e.g., 
availability of the FDA electronic submissions gateway (http://www.fda.gov/esg/default.htm)); and
     Collaborated with manufacturers, health care information 
suppliers, and other government agencies to develop data standards, and 
to build databases for sharing certain clinical trial information.
    Now that we have accomplished these preliminary steps, we are 
considering technological and other feasibility issues related to the 
electronic submission of premarket applications to FDA , as well as the 
electronic submission of other regulatory information (e.g., 
postmarketing information and amendments to applications).
    Facilitating electronic submissions and the electronic availability 
of product information would promote patient safety and better health 
outcomes, speed development of new medical technology, and allow health 
care professionals and consumers to make well informed decisions 
regarding the use of medical products. Such facilitations of electronic 
submissions would also support the Secretary's health IT priorities to 
harness information technology to improve healthcare and patient 
safety.
    As we work towards establishing a modern, paperless submission 
environment, we have also become aware of the potential benefits of a 
common electronic platform that could be administered by a third party 
entity or entities (e.g. private or nonprofit entities not otherwise 
engaged in clinical research activities) with relevant expertise and 
organizational leadership to facilitate, coordinate and manage the 
functions necessary for electronic submissions. For example, a third 
party entity might perform the following tasks:
     Build an electronic platform,
     Maintain data warehouses,
     Transition existing electronic data and information 
repositories to the electronic platform,
     Produce other necessary components to facilitate 
electronic access and management of information,
     Manage and support these functions.

III. Purpose and Scope of the Hearing

    The purpose of this public hearing is to provide stakeholders the 
opportunity to address specific topics (see section IV of this 
document) and present their views, recommendations, and any other 
pertinent information related to the scope of this public hearing.
    The scope of this public hearing includes the following three 
issues:
     Feasibility issues related to the electronic submission of 
premarket applications, including the effects on stakeholders of such 
actions;
     Feasibility issues related to electronic submissions of 
other regulatory information, e.g., postmarketing information and 
amendments to applications; and
     Issues related to the concept and feasibility of an 
electronic platform that would facilitate the exchange of clinical 
research information and other regulatory product information, the role 
of a public private partnership in the creation and assessment of such 
a platform, and the management of the platform after its creation by a 
private entity or entities with the relevant technological expertise.

IV. Issues for Discussion

A. Electronic Submissions

    We are specifically interested in hearing comments regarding the 
following questions and any other pertinent information related to the 
feasibility of the electronic submission of premarket applications and 
other regulatory information:
1. Transition From Paper Submissions to Electronic Submissions
     Since January 1999, we have accepted the voluntary 
electronic submission of certain premarket applications. If you are not 
voluntarily submitting such applications electronically, what is the 
reason(s)?
     Are you electronically submitting any portion of your 
premarket application? Is the portion specific to product type or 
premarket application?
     What are the major impediments to an all-electronic 
submission environment?
     How can FDA best address these impediments?
     Are there certain types of premarket applications or 
portions of applications that would be more difficult to submit 
electronically? Why?
     Are there specific issues related to electronic submission 
of premarket applications that are unique to small companies, academic 
institutions, and government agencies? If so, what are they and why are 
they unique?

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     In addition to the sponsors of premarket applications, are 
there other sectors of FDA regulated industry that would have to make 
adjustments in business practices in an all-electronic submission 
environment? Please describe any such adjustments.
     In your opinion, what internal expertise is needed for 
firms to make the transition to an all-electronic premarket submission? 
Do firms have this expertise?
     Is the labor market ready to accommodate industry's demand 
for such expertise to convert applications in an all-electronic 
submission environment?
     Are there enough entities available to provide such 
services or tools in support of this effort? If not, how long would it 
take for these services to become available?
     How would an all-electronic submission environment benefit 
you?
     Would an all-electronic submission environment change your 
ability to initiate in a timely manner the studies supporting your 
regulatory submission?
2. Cost
     What do you estimate as the cost burden to you if all 
premarket applications and related documents are submitted 
electronically? What is the breakdown of the cost (e.g., software, 
programming, hardware, training)?
     Would these costs differ depending on the type of entity 
providing services related to the application (e.g., sponsor, clinical 
research organization, U.S. agent)?
     What additional costs are associated with implementing a 
particular format or standard for an electronic premarket submission?
     Once the appropriate systems and processes are in place, 
and excluding startup costs, what would be the costs associated with 
providing an all-paper submission compared to an all-electronic 
submission?
     Are there parts of a product application that are more 
costly to convert to an electronic format than others?
3. Time
     Based on your current method of preparation to submit 
applications, how much time would be required for preparation to submit 
the entire application in an electronic format; or a portion by an 
entity providing services related to the application?
     How long would it take you to prepare and submit an 
application electronically under the current format accepted by FDA for 
voluntary submissions?
     How much time would you need to make a smooth transition 
to a new electronic system?
     How would your estimated time differ for various product 
types or applications?
4. Implementation
     Should we consider an incremental phase-in implementation 
strategy for an all-electronic submission environment? Is so, what 
should the strategy include? What is the order of priorities for 
phasing in implementation?
     What steps can we take to minimize the cost or other 
burdens of transitioning to an all-electronic submission environment?
     What additional standards or revisions to current 
electronic standards would be helpful to make electronic submissions 
work?
     Are the tools and formats currently available for FDA 
electronic submissions adequate? If not, why? What is needed?
     Are there other submission mechanisms more suitable and 
beneficial than what is currently available (e.g., the electronic 
submission gateway)?
     Are there factors, such as data formats or tools, for 
harmonization with other government entities, the private sector, or 
foreign regulatory authorities that could reduce costs or increase the 
benefits of electronic submissions?
     Would issuing guidance be useful in helping with the 
transition? If so, what topics would you like addressed?

B. Third Party Entities

    As previously described in section II of this document, we are 
considering issues related to the concept and feasibility of an 
electronic platform that would facilitate the exchange of clinical 
research information and other regulatory product information, and the 
role of a public private partnership in the creation and assessment of 
such a platform. In addition, we are considering whether the functions 
of the platform could be assumed by a private entity or entities with 
the relevant technological expertise. Therefore, we are interested in 
hearing your presentation on the following questions.
     What are your general viewpoints on a third party entity 
or entities providing services related to such an electronic platform?
     What are your views on the establishment of a public-
private partnership to initiate formation of an electronic platform?
     How do you envision the business process modeling and 
nature of the third party entity or entities?
     What are the necessary attributes and characteristics of 
the third party entity or entities?
     What services could the third party entity or entities 
provide?
     What collaborative efforts by FDA with a third party 
entity would be beneficial to establish services?

V. Notice of Hearing Under 21 CFR Part 15

    The Acting Commissioner of Food and Drugs (the Acting Commissioner) 
is announcing that the public hearing will be held in accordance with 
part 15 (21 CFR part 15). The hearing will be conducted by a presiding 
officer, who will be accompanied by FDA senior management from the 
Office of the Commissioner, the Office of Policy and Planning, the 
Office of the Chief Counsel; and by senior management from the National 
Institutes of Health, particularly the National Cancer Institute.
    Persons who wish to participate in the part 15 hearing must file a 
written or electronic notice of participation with the Division of 
Dockets Management (see ADDRESSES and DATES). To ensure timely 
handling, any outer envelope should be clearly marked with the docket 
number found in brackets in the heading of this document, along with 
the statement ``Electronic Submission of Regulatory Information, and 
Creating an Electronic Platform for Enhanced Information Management.'' 
Requests to make a presentation should contain the potential 
presenter's name and title; address; telephone and fax number; e-mail 
address; affiliation, if any; the sponsor of the presentation (e.g., 
the organization paying travel expenses or fees), if any; and a brief 
summary of the presentation (including the discussion topic(s) that 
will be addressed).
    Under Sec.  15.30(f), the hearing is informal, and the rules of 
evidence do not apply. No participant may interrupt the presentation of 
another participant. Only the presiding officer and panel members may 
question any person during or at the conclusion of each presentation.
    Public hearings under part 15 are subject to FDA's policy and 
procedures for electronic media coverage of FDA's public administrative 
proceedings (part 10, subpart C (21 CFR part 10, subpart C)). Under 
Sec.  10.205, representatives of the electronic media may be permitted, 
subject to certain limitations, to videotape, film, or otherwise record 
FDA's public administrative proceedings, including presentations by 
participants.
    To the extent that the conditions for the hearing, as described in 
this

[[Page 67359]]

document, conflict with any provisions set out in part 15, this 
document acts as a waiver of those provisions as specified in Sec.  
15.30(h).

VI. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic notices of participation and 
comments for consideration. To permit time for all interested persons 
to submit data, information, or views on this subject, the 
administrative record of the hearing will remain open until February 
16, 2007. Persons who wish to provide additional materials for 
consideration should file these materials with the Division of Dockets 
Management (see ADDRESSES). You should annotate and organize your 
comments to identify the specific questions identified by topic to 
which they refer (see section IV of this document). Two paper copies of 
any mailed comments are to be submitted, except that individuals may 
submit one paper copy. Comments are to be identified with the docket 
number at the heading of this document. Received comments may be seen 
in Division of Dockets Management (see ADDRESSES) between 9 a.m. and 4 
p.m., Monday through Friday.

VII. Transcripts

    The hearing will be transcribed as stipulated in Sec.  15.30(b). 
Transcripts of the hearing will be available for review at the Division 
of Dockets Management (see ADDRESSES) and on the Internet at http://www.fda.gov/ohrms/dockets approximately 21 days after the hearing. You 
may place orders for copies of the transcript through the Freedom of 
Information Office (HFI-35), Food and Drug Administration, 5600 Fishers 
lane, rm. 6-30, Rockville, MD 20857, at a cost of 10 cents per page.

    Dated: November 15, 2006.
Janet Woodcock,
Deputy Commissioner for Operations.
[FR Doc. 06-9313 Filed 11-16-06; 2:12 pm]
BILLING CODE 4160-01-S