[Federal Register Volume 73, Number 216 (Thursday, November 6, 2008)]
[Pages 66050-66051]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-26528]



Food and Drug Administration

[Docket No. FDA-2008-N-0567]

Designating Additions to the Current List of Tropical Diseases in 
the Food and Drug Administration Amendments Act; Public Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public hearing; request for comments.


SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
hearing to obtain input on adding additional diseases to the list of 
tropical diseases recognized under the Food and Drug Administration 
Amendments Act (FDAAA), which adds a new section to the Federal Food, 
Drug, and Cosmetic Act (the act). The new section authorizes FDA to 
award priority review vouchers to sponsors of certain tropical disease 
product applications that meet the criteria specified by the act. The 
new section lists diseases considered to be ``tropical diseases'' for 
the purposes of this legislation, and provides for expansion of the 
list to include diseases meeting certain criteria. This public meeting 
is being held to obtain comments from the public on the criteria that 
should be used to determine whether an infectious disease should be 
added to the list, and to elicit suggestions for adding specific 

DATES: The public hearing will be held on December 12, 2008, 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. Submit written or 
electronic requests for oral presentations and comments by November 17, 
2008. Written or electronic comments will be accepted after the hearing 
until February 6, 2009.

ADDRESSES: The public hearing will be held at the National 
Transportation Safety Board Boardroom and Conference Center at 429 
L'Enfant Plaza, SW, Washington, DC 20594. Submit written comments to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to http://www.regulations.gov. All comments 
should be identified with the docket number found in brackets in the 
heading of this document. Transcripts of the hearing will be available 
for review at the Division of Dockets Management and on the Internet at 
http://www.regulations.gov approximately 30 days after the hearing.

Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20903, 301-796-0777, FAX: 301-847-
8753, e-mail: jeff.o'[email protected].


I. Background

    The new section, section 524 of the act (21 U.S.C. 360n), is 
designed to encourage development of new drug or biological products 
for prevention and treatment of certain tropical diseases affecting 
millions of people throughout the world. Section 524 provides a means 
by which the holder of an application for a tropical disease product 
may be eligible to receive a priority review voucher upon approval of 
that application. This voucher entitles the sponsor to be granted a 
priority review for a subsequent application of a drug or biologic, 
submitted under section 505(b)(1) of the act (21 U.S.C. 355(b)(1)) or 
section 351 of the Public Health Service Act (42 U.S.C. 262), of the 
sponsor's choosing that would not otherwise be eligible for a priority 
review. FDA is committed to a goal of reviewing and taking an action 
within 6 months of receipt on 90% of applications that have been 
granted a priority review (see http://www.fda.gov/oc/pdufa4/pdufa4goals.html).
    To be granted a priority review voucher, the tropical disease 
application must meet all of the following criteria:
     The application must be a human drug application as 
defined in section 735(1) of the act (21 U.S.C. 379g(1)).
     The application must be for the prevention or treatment of 
a tropical disease.
     The tropical disease application must be eligible for 
priority review.
     The tropical disease application must be for ``a human 
drug, no active ingredient (including any ester or salt of the active 
ingredient) of which has been approved in any other application under 
section 505(b)(1) or section 351 of the Public Health service Act.''
    After being granted a priority review voucher, the owner of the 
voucher may transfer it to another sponsor. The sponsor intending to 
redeem a priority review voucher must notify the agency at least 365 
days prior to submission of the application for which the voucher is to 
be redeemed. This notification constitutes a legally binding agreement 
to pay a supplemental user fee that is mandated by the act to be 
applied to an application using a priority review voucher.

[[Page 66051]]

    The act identifies the following list of specific diseases that 
qualify as ``tropical diseases'' (section 524(a)(3)):
     Blinding trachoma
     Buruli Ulcer
     Dengue/Dengue haemorrhagic fever
     Dracunculiasis (guinea-worm disease)
     Human African trypanosomiasis
     Lymphatic filariasis
     Soil transmitted helminthiasis
    The legislation allows for the addition to this list of ``any other 
infectious disease for which there is no significant market in 
developed nations and that disproportionately affects poor and 
marginalized populations, designated by regulation by the Secretary.''
    This hearing is being convened to encourage feedback from the 
public regarding criteria that should by used to determine the 
eligibility of an infectious disease for inclusion in this list and the 
process that should be used to make additions to the list. FDA staff 
will provide an overview of section 524 at the beginning of the 

II. Scope of the Hearing

    FDA is interested in obtaining public comment on the following 
issues related to the tropical diseases listed in section 524 of the 
    1. Should other infectious diseases be added at this time to the 
list of tropical diseases that are eligible for receiving a priority 
review voucher? If so, are there specific infectious diseases that you 
believe should be added? Provide justification for your 
recommendations, consistent with the act's requirements for inclusion 
of additional tropical diseases.
    2. To be added to the list of tropical diseases, the act requires 
that the disease meet the following criteria:
     There must be no significant market in developed nations
     It must disproportionately affect poor and marginalized 
How should this language be interpreted?
    3. What procedures, prior to the rulemaking required by section 
524(a)(3), would facilitate the process for adding infectious diseases 
to the list of tropical diseases?

III. Notice of Hearing Under 21 CFR Part 15

    The Commissioner of Food and Drugs 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 Center for Drug Evaluation and Research, and the 
Center for Biologics Evaluation and Research.
    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 (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 
    If you wish to make an oral presentation during the hearing, you 
must submit a written or electronic request by close of business on 
Monday, November 17, 2008. You must provide your name, title, business 
affiliation (if applicable), address, and type of organization you 
represent (e.g., industry, consumer organization), and a brief summary 
of the presentation (including the discussion topic(s) that will be 
addressed to Jeff O'Neill at jeff.o'[email protected] (see FOR FURTHER 
INFORMATION CONTACT). Persons registered to make an oral presentation 
should check in before the hearing.
    Participants should submit a copy of each presentation to the 
contact person (see FOR FURTHER INFORMATION CONTACT). We will file the 
hearing schedule with the Division of Dockets Management (see 
ADDRESSES), indicating the order of presentation and time allotted to 
each person. We will also mail or fax the schedule to each participant 
before the hearing. Participants are encouraged to arrive early to 
ensure the designated order of presentation.
    Attendees who do not wish to make an oral presentation do not need 
to register. The meeting is free and seating will be on a first-come, 
first-served basis.
    The hearing will be transcribed as stipulated in Sec.  15.30(b). 
Transcripts will be available 45 days after the hearing on the Internet 
at http://www.regulations.gov. It may be viewed at the Division of 
Dockets Management (see ADDRESSES). A transcript will also be available 
in either hard copy or on CD-ROM after submission of a Freedom of 
Information request. Written requests are to be sent to the Division of 
Freedom of Information (HFI-35), Office of Management Programs, Food 
and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 
    Any handicapped persons requiring special accommodations to attend 
the hearing should direct those needs to the contact person (see FOR 
    To the extent that the conditions for the hearing, as described in 
this notice, conflict with any provisions set out in part 15, this 
notice acts as a waiver of those provisions as specified in Sec.  

IV. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments for consideration. 
Persons who wish to provide additional materials for consideration 
should file these materials with the Division of Dockets Management. 
You should annotate and organize your comments to identify the specific 
questions identified by topic to which they refer. Submit a single copy 
of electronic comments or two paper copies of any mailed comments, 
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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: October 29, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-26528 Filed 11-5-08; 8:45 am]