[Federal Register Volume 77, Number 222 (Friday, November 16, 2012)]
[Pages 68789-68790]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-27931]



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.


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: [email protected].
    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.


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 
    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 
    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.  

    Dated: November 13, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-27931 Filed 11-15-12; 8:45 am]