[Federal Register: September 21, 2007 (Volume 72, Number 183)]
[Notices]
[Page 54045-54047]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21se07-97]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0347]
Information Technology Strategic Planning; Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; Request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting to solicit views and information from interested persons on
issues concerning how the agency can best plan and apply information
technology (IT) resources to support the process for the review of
human drug applications. In particular, FDA is seeking views and
information from interested persons to identify and prioritize IT
solutions that will support the process for the review of human drug
applications. To help solicit such information and views, FDA is
seeking responses to specific questions (see section IV of this
document).
DATES: Public Meeting: The public meeting will be held on October 19,
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2007, 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 meeting 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 Carolyn Yancey (see
FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the
meeting.
Comments: Submit written or electronic notices of participation and
comments by 2 weeks prior to the public meeting. The docket for this
meeting will remain open to receive additional comments until 15 days
after the meeting date.
ADDRESSES: The public meeting will be held at the Advisors and
Consultants Staff Conference Room, FDA, 5630 Fishers Lane, Rockville,
MD 20857. Additional information on parking and public transportation
may be accessed at http://www.fda.gov/oc/pdufa/default.htm.
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: Carolyn Yancey, Office of Chief
Information Officer (HFA-80), Food and Drug Administration, 5600
Fishers Lane, Rm. 16B-45, Rockville, MD 20857, 301-827-4302,
carolyn.yancey@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. How to Participate in the Meeting
If you wish to make an oral presentation during the meeting, you
must submit a written notice of participation with the Division of
Dockets Management (see ADDRESSES) no later than 2 weeks prior to the
public meeting (see 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.'' In the
written notice, submit 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 or other pertinent
information related to the topic in your presentation). If there are
multiple participants please include 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 Division of Dockets Management two
copies of each presentation. We will file the meeting 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
meeting. In anticipation of the meeting 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 years, FDA has agreed to several IT-related performance
commitments, starting with computer assisted reviews in the
Prescription Drug User Fee Act (PDUFA) I, and continuing with the PDUFA
III Electronic Applications and Submission Goals in which FDA committed
to implementing the electronic Common Technical Document (eCTD) and a
common solution for the secure exchange of content, including secure e-
mail and electronic submissions. FDA met these commitments by
implementing the Electronic Submissions Gateway at http://www.fda.gov/esg/
and an electronic system for facilitating the receipt and review
of submissions in the eCTD format (http://www.fda.gov/cder/regulatory/ersr/ectd.htm
). In addition, FDA implemented the first phase of the
electronic labeling rule in the Center for Drug Evaluation and Research
at http://www.fda.gov/oc/datacouncil/spl.html.
Simultaneously, the Federal Government has also been pursuing
healthcare electronic standards. In 2004, the President issued
Executive Order 13335 establishing the position of the National
Coordinator for Health Information Technology within the Office of the
Secretary of Health and Human Services (HHS). The primary purpose of
this position is to aid the Secretary of HHS in achieving the
President's goal for most Americans to have access to an interoperable
electronic medical record by 2014. One of the key initiatives under the
Office of the National Coordinator was the establishment of the Health
Information Technology Standards Panel--a public-private partnership
with broad participation across more than 300 health-related
organizations--to identify and harmonize data and technical standards
for healthcare. Adding to the complexity of the healthcare movement
towards a standards-based approach is the impact this may have on the
regulated entities, from the small startup companies and research
organizations, to the large multinational companies who submit
regulatory submissions globally and are requesting global coordination
on healthcare standards.
During this timeframe FDA published IT plans to communicate FDA's
overall direction and strategy in meeting IT-related performance goals
and to describe our efforts in moving towards an electronic submission
and review environment. In producing the previous IT plans FDA
developed the plans internally and published the plans on the web--for
example at http://www.fda.gov/oc/pdufa/default.htm. As FDA moves
towards an automated standards-based electronic review environment, the
agency is seeking public input on the type of information to be
included in future IT plans that will provide our external stakeholders
the information needed to be in alignment with the program direction
and goals.
III. Purpose and Scope of the Meeting
The purpose of this public meeting 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 meeting. The
scope of this public meeting includes the following areas:
1. The content of IT plans that is most useful to external
stakeholders,
2. The data standards and guidance that best support available IT
capabilities and any implementation considerations, and
3. How agency architecture and IT solutions can best be applied to
support public health mission needs.
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IV. Issues for Discussion
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 related to the review of human drug
applications including postmarket data sources:
1. What would help improve the quality of electronic submissions to
the agency?
2. What would help increase the quantity of electronic submissions
to the agency?
3. How would you prioritize these quality and quantity
improvements?
4. What data standards are needed to implement these improvements?
5. How should FDA engage stakeholders while developing, testing,
and implementing these solutions?
6. What topics are most useful to include in IT plans?
7. What lead time is needed for stakeholders to respond to and be
in alignment with FDA initiatives?
8. How should FDA coordinate with stakeholders on the adoption and
implementation of data standards?
9. What data standards areas provide the greatest challenge?
10. What approaches will facilitate the most effective and
efficient adoption and implementation of data standards?
11. What key areas require new or expanded electronic submissions
guidance?
12. What lessons learned and best practices should FDA consider as
we transition from program-specific to enterprise IT solutions using a
reusable and modular model?
13. What specific concerns (i.e., security, confidentiality, etc.)
exist for a third party entity or entities providing services related
to electronic submissions and review and how can they be addressed?
V. Notice of Public Meeting
The Commissioner of Food and Drugs is announcing that the public
meeting will be conducted by FDA senior management. Persons who wish to
participate in the meeting must file a written or electronic notice of
participation with the Division of Dockets Management (see ADDRESSES
and DATES). 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. Under 21
CFR 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.
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 meeting will remain open until 2 weeks
prior to the public meeting. 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 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 found
in brackets in the heading of this document. Received comments may be
seen in Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.
VII. Transcripts
The meeting will be transcribed. Transcripts of the meeting 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 meeting. 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: September 17, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07-4692 Filed 9-18-07; 12:12 pm]
BILLING CODE 4160-01-P