[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