[Federal Register Volume 75, Number 138 (Tuesday, July 20, 2010)]
[Notices]
[Pages 42103-42104]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-17619]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0364]


Advancing the Development of Medical Products Used In the 
Prevention, Diagnosis, and Treatment of Neglected Tropical Diseases; 
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 related to advancing the development of medical 
products (drugs, biological products, and medical devices) used in the 
prevention, diagnosis, and treatment of neglected tropical diseases. In 
particular, FDA is seeking these views and information from interested 
persons on preclinical studies, trial design, regulatory approaches, 
and optimal solutions as they relate to the prevention, diagnosis, and 
treatment of neglected tropical diseases. To help solicit such views 
and information, FDA is seeking comments on specific issues (see 
section IV of this document).

DATES: Public Hearing: The public hearing will be held on September 22, 
2010, from 9 a.m. to 5 p.m. However, depending on the level of public 
participation, the meeting may extend later or end early.
    Registration: Interested parties are encouraged to register early. 
Registration is free. Seating will be available on a first-come, first-
served basis. To register, e-mail your name, title, firm name, address, 
and telephone numbers to [email protected] or call Ann 
Staten at 301-796-8504 by September 17, 2010.
    Registration on the day of the public hearing will be provided on a 
space-available basis beginning at 7:30 a.m. To allow sufficient time 
for parking and clearance through security, we recommend arriving 
early. See section I of the SUPPLEMENTARY INFORMATION section for 
information on how to participate in the meeting. If you need special 
accommodations due to a disability, please contact Ann Staten (see FOR 
FURTHER INFORMATION CONTACT) at least 7 days in advance.
    Notice of Participation and Comments: Submit written or electronic 
notices of participation and comments by September 1, 2010. The 
administrative record of the hearing will remain open to receive 
additional comments until October 20, 2010.

ADDRESSES: Public Hearing: The public hearing will be held at 10903 New 
Hampshire Ave., Bldg. 31, rm. 1503 (the Great Room), Silver Spring, MD 
20993. You must enter through Bldg. 1 and the security check-point to 
reach Bldg. 31. Additional information on parking may be accessed at 
http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/default.htm.
    Notice of Participation and Comments: Submit notices of 
participation and comments, identifying the agency and Docket No. FDA-
2010-N-0364, by any of the following methods:
Electronic Submissions
    Submit electronic notices of participation and comments in the 
following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for making submissions.
Written Submissions
    Submit written notices of participation and comments in the 
following ways:
     Fax: 301-827-6870.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Ann M. Staten, Office of Critical 
Path Programs, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg., 32, rm. 4106, Silver Spring, MD 20993-0002, 301-796-8504, 
[email protected].

SUPPLEMENTARY INFORMATION:

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 (see ADDRESSES) by September 1, 2010. In the written 
notice, submit your name, title, business affiliation, address, 
telephone number, and e-mail address. You should also submit a written 
statement for each issue in section IV of this document that you intend 
to address, and other pertinent information related to the topic in 
your presentation, the names and addresses of all individuals who 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 a copy of each presentation.
    We will file the hearing schedule indicating the order of 
presentation and the time allotted to each person to the docket. We 
will also e-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

    Approximately one billion people worldwide suffer from neglected 
tropical diseases, e.g., malaria, tuberculosis, and schistosomiasis. 
Developing medical products to prevent, diagnose, and treat neglected 
tropical diseases has not met global public health needs due to an 
array of challenges. To encourage the development of these much needed 
medical products, section 740 of the Agriculture, Rural Development, 
Food and Drug Administration, and Related Agencies Appropriation Act of 
2010 (Public Law 111-80) directs FDA to establish a review group to 
recommend to the Commissioner of Food and Drugs (the Commissioner) 
appropriate preclinical studies, trial design, regulatory approaches, 
and optimal solutions to encourage the development of medical products 
to prevent, diagnose, and treat neglected tropical diseases of the 
developing world.

III. Purpose and Scope of the Hearing

    The purpose of this public hearing is to provide advocates for 
patients with neglected tropical diseases, academics, health care 
providers, the pharmaceutical and medical device industries, and other 
interested parties an opportunity to address specific topics (see 
section IV of this document) and present to FDA their views, 
recommendations, and any other pertinent information related to the 
scope of this public hearing. This information will assist the FDA 
review group in making recommendations to the Commissioner regarding 
appropriate preclinical studies, trial design,

[[Page 42104]]

regulatory approaches, and optimal solutions to prevent, diagnose, and 
treat neglected tropical diseases.
    The scope of this public hearing includes the issues described in 
sections IV.A and IV.B of this document. In addressing these issues, we 
ask that your comments focus particularly on preclinical studies, trial 
design, regulatory approaches, and optimal solutions as they relate to 
the prevention, diagnosis, and treatment of neglected tropical 
diseases. We are also providing a few examples of discussion items that 
would apply to each issue. However, we encourage you to comment on any 
subject related to the headings of sections IV.A and IV.B of this 
document.

IV. Issues for Discussion

A. What are the challenges to developing drugs, biological products, 
and medical devices used to prevent, diagnose, and treat neglected 
tropical diseases? What are the specific areas and diseases where 
progress is needed?

    At a minimum, consider the following:
     Preclinical testing
     Trial design
     Regulatory approaches

B. What can be done to advance the development of products used to 
prevent, diagnose, and treat neglected tropical diseases in the 
developing world?

    At a minimum, consider the following:
     The perceived challenges in obtaining FDA approval or 
clearance of a premarket submission for a product used to prevent, 
diagnose, or treat a neglected tropical disease
     The perceived benefit or non-benefit of:
    [cir] orphan status designation
    [cir] the priority review voucher program under section 524 of the 
Federal Food, Drug and Cosmetic Act (21 U.S.C. 360n)
    [cir] the humanitarian use device (HUD) and the humanitarian device 
exemption (HDE) program
    [cir] other potential incentives
     Novel approaches to advance the development of products 
for neglected tropical diseases and regulatory approaches
     New strategies for international cooperation, 
consultation, and collaboration in the review and approval of these 
products
     Training or guidance necessary to support the development 
of products for neglected tropical diseases

V. Notice of Hearing Under Part 15

    The Commissioner is announcing that the public hearing will be held 
in accordance with 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 Economics Staff, the Center 
for Drug Evaluation and Research, the Center for Biologics Evaluation 
and Research, the Center for Devices and Radiological Health, and the 
Office of the Chief Counsel.
    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). Requests to make a 
presentation should contain the potential presenter's name and title; 
address; telephone 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 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. Requests for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written notices of participation 
and comments for consideration at the hearing. 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 October 20, 2010. You should annotate and organize your comments 
to identify the specific issues to which they refer (see section IV of 
this document). It is only necessary to send one set of comments. It is 
no longer necessary to send two copies of mailed comments. Identify 
submissions with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management 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). 
Please be advised that as soon as a transcript is available, it will be 
accessible at http://www.regulations.gov. It may be viewed at the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD. A transcript will also be 
available in either hardcopy or on CD-ROM, after submission of a 
Freedom of Information request. Written requests are to be sent to 
Division of Freedom of Information (HFI-35), Office of Management 
Programs, Food and Drug Administration, 5600 Fishers Lane, Rm. 6-30, 
Rockville, MD 20857.

    Dated: July 14, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-17619 Filed 7-19-10; 8:45 am]
BILLING CODE 4160-01-S