[Federal Register Volume 77, Number 222 (Friday, November 16, 2012)]
[Notices]
[Pages 68789-68790]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-27931]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-1037]
Establishing a List of Qualifying Pathogens That Have the
Potential To Pose a Serious Threat to Public Health; 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 public
hearing to obtain input on establishing a list of qualifying pathogens
(i.e., those that have the potential to pose a serious threat to public
health), as required under the Food and Drug Administration Safety and
Innovation Act (FDASIA). This public hearing is being held to obtain
comments from the public to determine the methodology that should be
used in developing the list of qualifying pathogens, and to elicit
suggestions for adding specific pathogens to the list.
DATES: Date and Time: The public hearing will be held on December 18,
2012, from 9 a.m. to 5 p.m. However, depending on the level of public
participation, the hearing may be extended or may end early.
Location: The public hearing will be held at FDA's White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31, the Great Room (rm. 1503),
Silver Spring, MD 20993. Entrance for the public meeting participants
(non-FDA employees) is through Building 1 where routine security check
procedures will be performed. For parking and security information,
please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
Contact Person: Lee Lemley, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993, 301-796-7563, FAX: 301-847-8753, email: CDER-GAINPublicMtg@fda.hhs.gov.
Registration: The public hearing is free and seating will be on a
first-come, first-served basis. Attendees who do not wish to make an
oral presentation do not need to register.
If you need special accommodations due to a disability, please
contact Lee Lemley (see Contact Person) at least 7 days in advance.
Requests for Oral Presentations: If you wish to make an oral
presentation during the public hearing, you must register by submitting
either an electronic or written request by close of business on
December 3, 2012. You must provide your name, title, business
affiliation (if applicable), address, email address, and phone 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 Lee Lemley (see Contact Person).
You should identify which question(s) set forth in section II of this
document you wish to address so that FDA can consider that in
organizing the presentations.
FDA will notify registered presenters of their scheduled times, and
will make available an agenda at http://www.fda.gov/Drugs/NewsEvents/ucm319619.htm. Once FDA notifies registered presenters of their
scheduled times, presenters should submit an electronic copy of their
presentation to Lee Lemley (see Contact Person) no later than December
12, 2012. Persons registered to make an oral presentation should check
in before the hearing, and are encouraged to arrive early to ensure the
designated order of presentation.
A live Webcast of this public hearing will be viewable at the
following Web site: https://collaboration.fda.gov/gain121812/. A video
record of the public hearing will be available at the same Web site for
1 year.
Comments: Regardless of attendance at the public hearing,
interested persons may submit either written comments to the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852 or electronic comments to
http://www.regulations.gov. Submit electronic or written comments by
December 3, 2012. You should annotate and organize your comments so
that they identify the specific questions to which they refer. It is
only necessary to send one set of comments. Identify comments 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, and will be posted to
the docket at http://www.regulations.gov.
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 January 25, 2013.
Transcripts: 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
[[Page 68790]]
(see Comments). 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 the Division of Freedom of
Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn
Dr., Element Bldg., Rockville, MD 20857.
SUPPLEMENTARY INFORMATION:
I. Background
Title VIII of FDASIA (Pub. L. 112-144), entitled ``Generating
Antibiotic Incentives Now (GAIN),'' amended the Federal Food, Drug, and
Cosmetic Act (FD&C Act) to add new section 505E (21 U.S.C. 355E), among
other things. This new section of the FD&C Act is designed to encourage
development of treatments for serious or life-threatening infections
caused by bacteria or fungi. For an application for a drug that is
designated a ``qualified infectious disease product'' under section
505E(d) of the FD&C Act, section 505E(a) provides an extension of 5
years of market exclusivity to the exclusivity periods provided by
sections 505(c)(3)(E)(ii) through (c)(3)(E)(iv) (21 U.S.C.
355(c)(3)(E)(ii) through (c)(3)(E)(iv)), 505(j)(5)(F)(ii) through
(j)(5)(F)(iv) (21 U.S.C. 355(j)(5)(F)(ii) through (j)(5)(F)(iv)), 505A
(21 U.S.C. 355a), and 527 (21 U.S.C. 360cc) of the FD&C Act. However,
as section 505E(c) of the FD&C Act states, not all applications for a
``qualified infectious disease product'' are eligible for the
additional market exclusivity. In addition, an application for a drug
designated as a ``qualified infectious disease product'' is eligible
for priority review and fast track status (sections 524A and 506(a)(1)
of the FD&C Act (21 U.S.C. 356(a)(1))), respectively.
The term ``qualifying infectious disease product'' refers to an
antibacterial or antifungal human drug that is intended to treat
serious or life-threatening infections (section 505E(g) of the FD&C
Act). It includes treatments for diseases caused by antibiotic- or
antifungal-resistant pathogens (including new or emerging pathogens),
or ``qualifying pathogens'' listed by the Secretary of the Department
of Health and Human Services (and, by delegation, FDA) under section
505E(f) (section 505E(g) of the FD&C Act).
According to the statute, ``the term `qualifying pathogen' means a
pathogen identified and listed by the Secretary * * * that has the
potential to pose a serious threat to public health, such as[:] (A)
resistant [G]ram positive pathogens, including methicillin-resistant
Staphylococcus aureus, vancomycin-resistant Staphylococcus aureus, and
vancomycin-resistant [E]nterococcus; (B) multi-drug resistant [G]ram[-
]negative bacteria, including Acinetobacter, Klebsiella, Pseudomonas,
and E. coli species; (C) multi-drug resistant tuberculosis; and (D)
Clostridium difficile'' (section 505E(f)(1) of the FD&C Act). FDA is
required under the law to consider four factors in establishing and
maintaining the list of qualifying pathogens:
The impact on the public health due to drug-resistant
organisms in humans;
The rate of growth of drug-resistant organisms in humans;
The increase in resistance rates in humans; and
The morbidity and mortality in humans.
(section 505E(f)(2)(B)(i) of the FD&C Act). Furthermore, in determining
which pathogens should be listed, consultation with infectious disease
and antibiotic resistance experts, including those in the medical and
clinical research communities, along with the Centers for Disease
Control and Prevention (CDC), is required (section 505E(f)(2)(B)(ii) of
the FD&C Act).
II. Purpose and Scope of the Hearing
We are holding this hearing to fulfill the statutory consultation
requirement and to obtain public comment on the following issues
related to establishing the list of qualifying pathogens described in
section 505E(f) of the FD&C Act:
1. FDASIA requires FDA to ``consider'' the following factors in
establishing and maintaining the list of qualifying pathogens:
The impact on the public health due to drug-resistant
organisms in humans;
The rate of growth of drug-resistant organisms in humans;
The increase in resistance rates in humans; and
The morbidity and mortality in humans.
How should these factors be applied to a pathogen to determine whether
it should be included in the list?
2. Aside from the considerations noted in question 1 (i.e., those
required by section 505(E)(f)(2)(B)(i) of the FD&C Act), are there any
other factors FDA should consider when establishing and maintaining the
list of qualifying pathogens? If so, how should these factors be
applied to a pathogen to determine whether it should be included in the
list?
3. Which specific pathogens do you believe should be listed as
qualifying pathogens? Provide justification for your recommendations,
including how you applied the considerations described in section
505E(f)(2)(B)(i) of the FD&C Act, and any other factors that you
considered, in recommending the pathogen for inclusion on the list of
qualifying pathogens.
III. Notice of Hearing Under 21 CFR Part 15
The Commissioner of Food and Drugs (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, who
will be accompanied by FDA senior management from the Office of the
Commissioner and the Center for Drug 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 (see 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 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).
Dated: November 13, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-27931 Filed 11-15-12; 8:45 am]
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