[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