[Federal Register Volume 73, Number 216 (Thursday, November 6, 2008)]
[Notices]
[Pages 66050-66051]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-26528]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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
diseases.
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.
FOR FURTHER INFORMATION CONTACT: Jeff O'Neill, Center for Drug
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'neill@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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)):
Tuberculosis
Malaria
Blinding trachoma
Buruli Ulcer
Cholera
Dengue/Dengue haemorrhagic fever
Dracunculiasis (guinea-worm disease)
Fascioliasis
Human African trypanosomiasis
Leishmaniasis
Leprosy
Lymphatic filariasis
Onchocerciasis
Schistosomiasis
Soil transmitted helminthiasis
Yaws
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
meeting.
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
act:
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
populations.
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
participants.
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'neill@fda.hhs.gov (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
20857.
Any handicapped persons requiring special accommodations to attend
the hearing should direct those needs to the contact person (see FOR
FURTHER INFORMATION CONTACT).
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.
15.30(h).
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]
BILLING CODE 4160-01-S