82 FR 11923 - Current State and Further Development of Animal Models of Serious Infections Caused by Acinetobacter baumannii and Pseudomonas aeruginosa; Public Workshop
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 37 (February 27, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 37 (February 27, 2017)
| Page Range | 11923-11924 | |
| FR Document | 2017-03751 |
[Federal Register Volume 82, Number 37 (Monday, February 27, 2017)] [Notices] [Pages 11923-11924] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-03751] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-0696] Current State and Further Development of Animal Models of Serious Infections Caused by Acinetobacter baumannii and Pseudomonas aeruginosa; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing a public workshop regarding the current state and further development of animal models for serious infections caused by Acinetobacter baumannii and Pseudomonas aeruginosa. FDA is conducting this workshop in order to facilitate the development of narrow-spectrum antibacterial drugs, such as those that are active against only a single species of bacteria that may not occur frequently. This public workshop is intended to provide information for and gain perspective from health care providers, other U.S. Government Agencies, academic experts, contract research organizations, and industry on various aspects of development efforts pertaining to animal models of serious infections. The input from this public workshop will also help FDA in developing topics for future discussion. DATES: The public workshop will be held on March 1, 2017, from 8:30 a.m. to 5 p.m. Submit either electronic or written comments on this public workshop by March 15, 2017. See the SUPPLEMENTARY INFORMATION section for registration information. The workshop draft Agenda will be made available at: http://www.fda.gov/Drugs/NewsEvents/ucm534031.htm prior to the meeting. ADDRESSES: The public workshop will be held at the DoubleTree by Hilton Hotel Washington DC-Silver Spring, 8727 Colesville Rd., Silver Spring, MD 20910. The hotel's phone number is 301-589-5200. You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2017-N-0696 for ``Current State and Further Development of Animal Models of Serious Infections Caused by Acinetobacter baumannii and Pseudomonas aeruginosa.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two [[Page 11924]] copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Lori Benner and/or Jessica Barnes, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6221, Silver Spring, MD 20993- 0002, 301-796-1300. SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop regarding animal model development for infectious diseases. FDA is conducting this workshop in order to facilitate the development of narrow-spectrum antibacterial drugs, such as those that are active against only a single species of bacteria that may not occur frequently. When the species occurs infrequently, performing clinical trials can be extremely challenging. Therefore, animal models of infection may be useful to explore the activity of a candidate antibacterial drug and may help to predict whether the drug will be efficacious in humans. A discussion of the additional scientific work needed to evaluate current animal models of infection and evaluate potential animal models that may predict response in humans could advance the development of antibacterial drugs targeting a single species. FDA is particularly interested in infections due to Acinetobacter baumannii and Pseudomonas aeruginosa as pathogens because there are limited therapeutic options to treat patients with serious infections caused by these bacteria, including those resistant to currently available antibacterial drugs. In addition, it is difficult to enroll an adequate number of patients to conduct clinical trials since the frequency with which these organisms cause clinical disease is sufficiently low. Discussions will focus on the current state of animal models of serious infections, lessons learned from the development efforts for past and current animal models of infection, and scientific challenges and future direction and next steps in animal model development. This public workshop is intended to provide information for and gain perspective from health care providers, other U.S. Government Agencies, academic experts, contract research organizations, and industry on various aspects of development efforts pertaining to animal models of serious infections. The input from this public workshop will also help FDA in developing topics for future discussion. The Agency encourages health care providers, other U.S. Government Agencies, academic experts, contract research organizations, industry, and other interested persons to attend this public workshop. Registration: Interested parties are encouraged to register early. To register electronically, email registration information (including name, title, firm name, address, telephone, and fax number) to [email protected]. Persons without access to the Internet can call 301-796-1300 to register. Registration is free and will be on a first-come, first-served basis. However, FDA may limit the number of participants from each organization based on space limitations. Registrants will receive confirmation once they have been accepted. Onsite registration on the day of the meeting will be based on space availability. If you need special accommodations due to a disability, please contact Jessica Barnes or Lori Benner (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance. Requests for Oral Presentations: During online registration you may indicate if you wish to present during a public comment session, and which topic(s) you wish to address. We will do our best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation. All requests to make oral presentations must be received by February 27, 2017. We will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will select and notify participants on or before February 28, 2017. If selected for presentation, any presentation materials must be emailed to [email protected] no later than February 28, 2017. No commercial or promotional material will be permitted to be presented or distributed at the public workshop. Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. The Freedom of Information office address is available on the Agency's Web site at http://www.fda.gov. Transcripts will also be available on the Internet at: http://www.fda.gov/Drugs/NewsEvents/ucm534031.htm approximately 45 days after the workshop. Dated: February 21, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-03751 Filed 2-24-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 37 / Monday, February 27, 2017 / Notices 11923
of value to physicians and teaching Dated: February 22, 2017. Electronic Submissions
hospitals, as well as, certain information William N. Parham, III, Submit electronic comments in the
regarding the ownership or investment Director, Paperwork Reduction Staff, Office following way:
interests held by physicians or their of Strategic Operations and Regulatory • Federal eRulemaking Portal:
immediate family members in Affairs.
https://www.regulations.gov. Follow the
applicable manufacturers or applicable [FR Doc. 2017–03809 Filed 2–24–17; 8:45 am]
instructions for submitting comments.
GPOs. BILLING CODE 4120–01–P
Comments submitted electronically,
Specifically, applicable manufacturers including attachments, to https://
of covered drugs, devices, biologicals, www.regulations.gov will be posted to
DEPARTMENT OF HEALTH AND
and medical supplies are required to the docket unchanged. Because your
HUMAN SERVICES
submit on an annual basis the comment will be made public, you are
information required in section Food and Drug Administration solely responsible for ensuring that your
1128G(a)(1) of the Act about certain comment does not include any
[Docket No. FDA–2017–N–0696] confidential information that you or a
payments or other transfers of value
third party may not wish to be posted,
made to physicians and teaching Current State and Further
such as medical information, your or
hospitals (collectively called covered Development of Animal Models of
anyone else’s Social Security number, or
recipients) during the course of the Serious Infections Caused by
confidential business information, such
preceding calendar year. Similarly, Acinetobacter baumannii and
as a manufacturing process. Please note
section 1128G(a)(2) of the Act requires Pseudomonas aeruginosa; Public
that if you include your name, contact
applicable manufacturers and Workshop
information, or other information that
applicable GPOs to disclose any AGENCY: Food and Drug Administration, identifies you in the body of your
ownership or investment interests in HHS. comments, that information will be
such entities held by physicians or their ACTION: Notice of public workshop; posted on https://www.regulations.gov.
immediate family members, as well as request for comments. • If you want to submit a comment
information on any payments or other with confidential information that you
transfers of value provided to such SUMMARY: The Food and Drug do not wish to be made available to the
physician owners or investors. Administration (FDA) is announcing a public, submit the comment as a
Applicable manufacturers must report public workshop regarding the current written/paper submission and in the
the required payment and other transfer state and further development of animal manner detailed (see ‘‘Written/Paper
of value information annually to CMS in models for serious infections caused by Submissions’’ and ‘‘Instructions’’).
an electronic format. The statute also Acinetobacter baumannii and
Pseudomonas aeruginosa. FDA is Written/Paper Submissions
provides that applicable manufacturers
conducting this workshop in order to Submit written/paper submissions as
and applicable GPOs must report
facilitate the development of narrow- follows:
annually to CMS the required
information about physician ownership
spectrum antibacterial drugs, such as • Mail/Hand delivery/Courier (for
those that are active against only a written/paper submissions): Division of
and investment interests, including single species of bacteria that may not Dockets Management (HFA–305), Food
information on any payments or other occur frequently. and Drug Administration, 5630 Fishers
transfers of value provided to physician This public workshop is intended to Lane, Rm. 1061, Rockville, MD 20852.
owners or investors, in an electronic provide information for and gain • For written/paper comments
format by the same date. Applicable perspective from health care providers, submitted to the Division of Dockets
manufacturers and applicable GPOs are other U.S. Government Agencies, Management, FDA will post your
subject to civil monetary penalties academic experts, contract research comment, as well as any attachments,
(CMPs) for failing to comply with the organizations, and industry on various except for information submitted,
reporting requirements of the statute. aspects of development efforts marked and identified, as confidential,
We are required by statute to publish pertaining to animal models of serious if submitted as detailed in
the reported data on a public Web site. infections. The input from this public ‘‘Instructions.’’
The data must be downloadable, easily workshop will also help FDA in Instructions: All submissions received
searchable, and aggregated. In addition, developing topics for future discussion. must include the Docket No. FDA–
we must submit annual reports to the DATES: The public workshop will be 2017–N–0696 for ‘‘Current State and
Congress and each state summarizing held on March 1, 2017, from 8:30 a.m. Further Development of Animal Models
the data reported. Finally, section to 5 p.m. Submit either electronic or of Serious Infections Caused by
1128G of the Act generally preempts written comments on this public Acinetobacter baumannii and
state laws that require disclosure of the workshop by March 15, 2017. See the Pseudomonas aeruginosa.’’ Received
same type of information by SUPPLEMENTARY INFORMATION section for comments will be placed in the docket
manufacturers. Form Number: CMS– registration information. The workshop and, except for those submitted as
10495 (OMB Control Number: 0938– draft Agenda will be made available at: ‘‘Confidential Submissions,’’ publicly
1237); Frequency: Once; Affected http://www.fda.gov/Drugs/NewsEvents/ viewable at https://www.regulations.gov
Public: Private sector—Business or other ucm534031.htm prior to the meeting. or at the Division of Dockets
ADDRESSES: The public workshop will Management between 9 a.m. and 4 p.m.,
mstockstill on DSK3G9T082PROD with NOTICES
for-profits; Number of Respondents:
be held at the DoubleTree by Hilton Monday through Friday.
227,157; Total Annual Responses:
Hotel Washington DC-Silver Spring, • Confidential Submissions—To
457,454; Total Annual Hours: 3,099,297.
8727 Colesville Rd., Silver Spring, MD submit a comment with confidential
(For policy questions regarding this information that you do not wish to be
20910. The hotel’s phone number is
collection contact Veronika Peleshchuk made publicly available, submit your
301–589–5200.
Fradlin at 410–786–3323.) You may submit comments as comments only as a written/paper
follows: submission. You should submit two
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![11924 Federal Register / Vol. 82, No. 37 / Monday, February 27, 2017 / Notices
copies total. One copy will include the models that may predict response in our best to accommodate requests to
information you claim to be confidential humans could advance the development make public comments. Individuals and
with a heading or cover note that states of antibacterial drugs targeting a single organizations with common interests are
‘‘THIS DOCUMENT CONTAINS species. urged to consolidate or coordinate their
CONFIDENTIAL INFORMATION.’’ The FDA is particularly interested in presentations, and request time for a
Agency will review this copy, including infections due to Acinetobacter joint presentation. All requests to make
the claimed confidential information, in baumannii and Pseudomonas oral presentations must be received by
its consideration of comments. The aeruginosa as pathogens because there February 27, 2017. We will determine
second copy, which will have the are limited therapeutic options to treat the amount of time allotted to each
claimed confidential information patients with serious infections caused presenter and the approximate time
redacted/blacked out, will be available by these bacteria, including those each oral presentation is to begin, and
for public viewing and posted on resistant to currently available will select and notify participants on or
https://www.regulations.gov. Submit antibacterial drugs. In addition, it is before February 28, 2017. If selected for
both copies to the Division of Dockets difficult to enroll an adequate number of presentation, any presentation materials
Management. If you do not wish your patients to conduct clinical trials since must be emailed to AnimalModels
name and contact information to be the frequency with which these InfectionWorkshop2017@fda.hhs.gov no
made publicly available, you can organisms cause clinical disease is later than February 28, 2017. No
provide this information on the cover sufficiently low. Discussions will focus commercial or promotional material
sheet and not in the body of your on the current state of animal models of will be permitted to be presented or
comments and you must identify this serious infections, lessons learned from distributed at the public workshop.
information as ‘‘confidential.’’ Any the development efforts for past and Transcripts: Please be advised that as
information marked as ‘‘confidential’’ current animal models of infection, and soon as a transcript is available, it will
will not be disclosed except in scientific challenges and future be accessible at https://
accordance with 21 CFR 10.20 and other direction and next steps in animal
www.regulations.gov. It may be viewed
applicable disclosure law. For more model development.
at the Division of Dockets Management
information about FDA’s posting of This public workshop is intended to
provide information for and gain (HFA–305), Food and Drug
comments to public dockets, see 80 FR Administration, 5630 Fishers Lane, Rm.
56469, September 18, 2015, or access perspective from health care providers,
other U.S. Government Agencies, 1061, Rockville, MD 20852. A transcript
the information at: http://www.fda.gov/ will also be available in either hardcopy
regulatoryinformation/dockets/ academic experts, contract research
organizations, and industry on various or on CD–ROM, after submission of a
default.htm. Freedom of Information request. The
Docket: For access to the docket to aspects of development efforts
pertaining to animal models of serious Freedom of Information office address is
read the electronic and written/paper available on the Agency’s Web site at
comments received, go to https:// infections. The input from this public
workshop will also help FDA in http://www.fda.gov. Transcripts will
www.regulations.gov and insert the also be available on the Internet at:
docket number, found in brackets in the developing topics for future discussion.
The Agency encourages health care http://www.fda.gov/Drugs/NewsEvents/
heading of this document, into the ucm534031.htm approximately 45 days
‘‘Search’’ box and follow the prompts providers, other U.S. Government
Agencies, academic experts, contract after the workshop.
and/or go to the Division of Dockets
research organizations, industry, and Dated: February 21, 2017.
Management, 5630 Fishers Lane, Rm.
other interested persons to attend this Leslie Kux,
1061, Rockville, MD 20852.
public workshop. Associate Commissioner for Policy.
FOR FURTHER INFORMATION CONTACT: Lori Registration: Interested parties are
Benner and/or Jessica Barnes, Center for [FR Doc. 2017–03751 Filed 2–24–17; 8:45 am]
encouraged to register early. To register
Drug Evaluation and Research, Food electronically, email registration
BILLING CODE 4164–01–P
and Drug Administration, 10903 New information (including name, title, firm
Hampshire Ave., Bldg. 22, Rm. 6221, name, address, telephone, and fax
Silver Spring, MD 20993–0002, 301– DEPARTMENT OF HEALTH AND
number) to AnimalModelsInfection HUMAN SERVICES
796–1300. Workshop2017@fda.hhs.gov. Persons
SUPPLEMENTARY INFORMATION: FDA is without access to the Internet can call National Institutes of Health
announcing a public workshop 301–796–1300 to register. Registration is
regarding animal model development free and will be on a first-come, first- National Heart, Lung, and Blood
for infectious diseases. FDA is served basis. However, FDA may limit Institute; Notice of Closed Meetings
conducting this workshop in order to the number of participants from each
facilitate the development of narrow- organization based on space limitations. Pursuant to section 10(d) of the
spectrum antibacterial drugs, such as Registrants will receive confirmation Federal Advisory Committee Act, as
those that are active against only a once they have been accepted. Onsite amended (5 U.S.C. App.), notice is
single species of bacteria that may not registration on the day of the meeting hereby given of the following meetings.
occur frequently. When the species will be based on space availability. The meetings will be closed to the
occurs infrequently, performing clinical If you need special accommodations public in accordance with the
trials can be extremely challenging. due to a disability, please contact Jessica provisions set forth in sections
Therefore, animal models of infection Barnes or Lori Benner (see FOR FURTHER 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
mstockstill on DSK3G9T082PROD with NOTICES
may be useful to explore the activity of INFORMATION CONTACT) at least 7 days in as amended. The grant applications and
a candidate antibacterial drug and may advance. the discussions could disclose
help to predict whether the drug will be Requests for Oral Presentations: confidential trade secrets or commercial
efficacious in humans. A discussion of During online registration you may property such as patentable material,
the additional scientific work needed to indicate if you wish to present during a and personal information concerning
evaluate current animal models of public comment session, and which individuals associated with the grant
infection and evaluate potential animal topic(s) you wish to address. We will do applications, the disclosure of which
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Document Created: 2017-02-25 01:05:30
Document Modified: 2017-02-25 01:05:30
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of public workshop; request for comments. | |
| Dates | The public workshop will be held on March 1, 2017, from 8:30 a.m. to 5 p.m. Submit either electronic or written comments on this public workshop by March 15, 2017. See the SUPPLEMENTARY INFORMATION section for registration information. The workshop draft Agenda will be made available at: http://www.fda.gov/Drugs/NewsEvents/ucm534031.htm prior to the meeting. | |
| Contact | Lori Benner and/or Jessica Barnes, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6221, Silver Spring, MD 20993- 0002, 301-796-1300. | |
| FR Citation | 82 FR 11923 |
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