[Federal Register Volume 72, Number 183 (Friday, September 21, 2007)]
[Notices]
[Pages 54045-54047]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-4692]


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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, 
[email protected].

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