[Federal Register Volume 73, Number 73 (Tuesday, April 15, 2008)]
[Notices]
[Pages 20309-20311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 08-1129]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0225]
Antimicrobial Resistance; Public Hearing; Request for Comments
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
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public hearing on antimicrobial resistance. FDA is seeking general
information about the problem of antimicrobial resistance,
recommendations as to possible approaches to contain the problem of
antimicrobial resistance, responses to specific questions (see section
III of this document), and other pertinent information from interested
parties. In addition, interested parties may provide views on which
serious and life-threatening infectious diseases, such as diseases due
to gram-negative bacteria and other diseases due to antimicrobial-
resistant bacteria, potentially qualify for available grants and
contracts or other development incentives.
DATES: The public hearing will be held April 28, 2008, from 8 a.m. to 5
p.m. Submit written or electronic notices of participation by close of
business on April 21, 2008. Written or electronic comments will be
accepted until May 26, 2008.
ADDRESSES: The public hearing will be held at the University System of
Maryland Shady Grove Center, 9630 Gudelsky Dr., Rockville, MD 20850.
See Registration to Attend and/or Participate in the Public Hearing
for instructions on how to submit electronic notices of participation.
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.
FOR FURTHER INFORMATION CONTACT: Nancy Stanisic, Office of Critical
Path Programs (HF-18), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1660, FAX 301-443-9718,
[email protected].
Registration to Attend and/or Participate in the Public Hearing: To
ensure there is sufficient room we ask that you pre-register. If you
wish to make an oral presentation during the open public comment period
of the hearing, state your intention to present on your registration
submission. To register, please send an electronic mail message to
[email protected] by April 21, 2008. Your e-mail should include
the following information:
Your name,
Title,
Business affiliation,
Address,
Telephone and fax numbers, and e-mail address.
Please submit a written statement at the time of registration,
identifying by number each discussion question you wish to address and
the approximate time requested to make your presentation. Organizations
should provide this information as well as the names and addresses of
all participants. Registered individuals will be notified of the
scheduled time for their presentation prior to the hearing. Depending
on the number of presentations, FDA may need to limit the time allotted
for presentations. However, the administrative record of the hearing
will remain open after the hearing, and written comments may be
submitted to the docket as described in section V of this document.
Presentations will be limited to the subject matter identified in
section III of this document.
FDA will accept walk-in registration at the site, but space is
limited. FDA will try to accommodate all persons who wish to make a
public comment at the hearing, including those who register at the
site. Registration is on a first-come, first-served basis.
Additionally, please notify FDA (see FOR FURTHER INFORMATION
CONTACT) if you need any special accommodations (such as wheelchair
access) at the time of registration.
SUPPLEMENTARY INFORMATION:
I. Background
Antimicrobial drug resistance is a major public health concern and
a threat to the effectiveness of existing antimicrobial drugs.
Antimicrobial resistant pathogens continue to emerge that are very
difficult to treat and that may cause serious or life-threatening
diseases. Emerging antimicrobial resistance among many bacteria (e.g.,
Pseudomonas species, Acinetobacter species, Enterococcus species,
Staphylococcus aureus, Streptococcus pneumoniae, and Mycobacterium
tuberculosis) and changes in virulence (e.g., Clostridium difficile,
group A Streptococci, Escherichia coli O157:H7, and Staphylococcus
aureus) are major public health concerns. Timely development of new
therapeutic agents is essential and use of existing therapies to treat
infections caused by these organisms should be optimized to preserve
their utility in treating infections and reduce the rate at which
resistance develops.
FDA has been working closely with other Government agencies and
organizations to address the issue of antimicrobial resistance. An
interagency Task Force began looking at antimicrobial resistance in
1999, and developed and published the Public Health Action Plan to
Combat Antimicrobial Resistance (Action Plan) (available at http://www.cdc.gov/drugresistance/actionplan/html/index.htm).\1\ FDA also
published a final rule in February 2003 that requires incorporation of
information on antimicrobial resistance and prudent use in the labeling
of systemic antibacterial drug products for human use (68 FR 6062,
February 6, 2003). FDA has held or participated in a number of meetings
on antimicrobial resistance, including an Anti-Infective Drugs Products
Advisory Committee in March 2003, an Infectious Diseases Society of
America/International Society of Anti-Infective Pharmacology/FDA
Workshop on Antimicrobial Drug Development in April 2004, and an FDA
Science Board Advisory Committee meeting on the Center for Veterinary
Medicine's National Antimicrobial Resistance Monitoring System in April
2007.
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\1\ (FDA has verified the Web site address, but FDA is not
responsible for any subsequent changes to the Web site after this
document publishes in the Federal Register.)
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In September 2007, Congress passed the Food and Drug Administration
Amendments Act (FDAAA), which was signed into law by the President on
September 27, 2007 (Public Law 110-85). Section 1112 (Orphan Antibiotic
Drugs) of FDAAA requires the Commissioner of Food and Drugs (the
Commissioner) to convene a public hearing to discuss which serious and
life-threatening infectious diseases, such as diseases caused by gram-
negative bacteria and other diseases due to antibiotic-resistant
bacteria, potentially qualify for available grants and contracts under
section 5(a) of the Orphan Drug Act (21 U.S.C. 360ee(a)) or other
incentives. For this reason, FDA is holding this public hearing.
Under the Orphan Drug Act (Public Law 97-414), a drug is an orphan
drug if it is intended for use in a rare disease or condition. Sponsors
of orphan drugs are eligible for certain research and development
incentives. During the period that an orphan drug is in development,
the sponsor may be awarded grant funding to defray the cost of
qualified clinical testing incurred in connection with the development
of the drug for a rare disease or condition. A drug that has been
designated as an orphan drug by FDA may receive 7 years of marketing
exclusivity for the drug for the designated orphan use upon approval.
To receive designation as an orphan drug (as defined in section 526 of
the Federal Food, Drug, and Cosmetic Act) (21 U.S.C. 360bb)), a sponsor
must meet the requirements in 21 CFR 316.20
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and 316.21. These requirements include, but are not limited to,
documentation of the following:
The disease or condition for which the drug is intended
affects fewer than 200,000 people in the United States (e.g.,
tuberculosis, malaria, trypanosomiasis).
If the drug is a vaccine, diagnostic drug, or preventative
drug, the persons to whom the drug will be administered in the United
States are fewer than 200,000 per year.
For a drug intended for diseases or conditions affecting
200,000 or more people, or for a vaccine, diagnostic drug, or
preventative drug to be administered to 200,000 or more persons per
year in the United States, there is no reasonable expectation that
costs of research and development of the drug for the indication can be
recovered by sales of the drug in the United States.
Antimicrobial drugs that have qualified for orphan drug designation
in the past include some indicated for the treatment of tuberculosis,
malaria, and trypanosomiasis.
II. Purpose and Scope of the Hearing
This hearing is intended to provide the infectious disease
community, sponsors, and other interested parties an opportunity to
discuss their experience with and concerns about the emerging threat of
antimicrobial resistance, possible strategies fostering prudent use to
prevent the development of antimicrobial resistance, and the potential
for the provisions of the Orphan Drug Act or other incentives to
facilitate antimicrobial drug development, including what, if any,
conditions might be required to accompany such incentives.
III. Issues for Discussion
FDA invites comments from interested parties on the following
questions:
1. Please discuss strategies that should be considered to limit the
development of antimicrobial resistance, and studies that could be done
to assess the utility, safety and effectiveness of those strategies.
Possible examples include limiting the approved conditions of use,
limiting the duration of therapy, restricting distribution to encourage
appropriate use, using shorter courses of therapy with higher doses of
antimicrobials, and using directly observed therapy.
2. Please discuss the possible utility and effectiveness of
economic incentives in promoting drug development for antimicrobial
resistant organisms.
a. What is the potential role of the Orphan Drug Act in providing
incentives to facilitate antimicrobial drug development? Please
describe the serious and life-threatening infectious diseases for which
the Orphan Drug Act provides viable research and development
incentives. Please comment on the potential complexities associated
with identifying appropriate orphan populations in the infectious
disease context.
b. Are there specific incentives (other than those provided by the
Orphan Drug Act) that could facilitate the development of new
antimicrobial therapies for serious and life-threatening diseases?
Describe those serious and life-threatening infectious diseases, such
as diseases due to gram-negative bacteria and other diseases due to
antimicrobial-resistant bacteria, which could be considered under an
alternative incentive program.
IV. Notice of Hearing Under 21 CFR Part 15
The Commissioner 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, accompanied by FDA senior management
from the Office of the Commissioner, the Center for Drug Evaluation and
Research, the Center for Biologics Evaluation and Research, and FDA's
Office of Orphan Drugs.
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. The hearing will be transcribed as stipulated in Sec.
15.30(b).
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 21 CFR
15.30(h).
V. Request for Comments
Regardless of attendance at the public hearing, interested persons
may submit written or electronic comments to the Division of Dockets
Management (see ADDRESSES). Submit a single copy of electronic comments
or two paper copies of any mailed comments, except that individuals may
submit one paper copy. Comments should be identified with the docket
number found in brackets in the heading of this document. To ensure
consideration, submit comments by (see DATES). Received comments may be
seen in the 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
through FDMS only.
VI. Transcripts
Please be advised that as soon as a transcript is available, it
will be accessible at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm.
It may be viewed at the Division of Dockets Management (see ADDRESSES).
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: April 9, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. 08-1129 Filed 4-10-08; 12:23 pm]
BILLING CODE 4160-01-S