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Notice

Advancing Animal Models for Antibacterial Drug Development; Public Workshop; Request for Comments

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Start Preamble

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop; request for comments.

SUMMARY:

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled “Advancing Animal Models for Antibacterial Drug Development.” The purpose of the public workshop is to discuss progress and challenges in the development of various animal models for serious infection funded by FDA, the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA) to facilitate antibacterial drug development, and to discuss ideas for future research. This public workshop is a follow up to the FDA public workshop held on March 1, 2017, entitled “Current Status and Future Development of Animal Models of Serious Infections Caused by Acinetobacter baumannii and Pseudomonas aeruginosa.”

DATES:

The public workshop will be held on March 5, 2020, from 8:30 a.m. to 4 p.m. Submit either electronic or written comments on this public workshop by April 6, 2020. See the SUPPLEMENTARY INFORMATION section for registration date and information.

ADDRESSES:

The public workshop will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993. Entrance for the public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to https://www.fda.gov/​AboutFDA/​WorkingatFDA/​BuildingsandFacilities/​WhiteOakCampusInformation/​ucm241740.htm.

You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 6, 2020. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time on April 6, 2020. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
  • For written/paper comments submitted to the Dockets Management Staff, 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-2019-N-6046 for “Advancing Animal Models for Antibacterial Drug Development.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 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 Dockets Management Staff. 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 Start Printed Page 6550of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.

Docket: For access to the docket to read background documents or 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

James Byrne, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6383, Silver Spring, MD 20993-0002, 301-796-5001.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing a public workshop to discuss ongoing research efforts to advance the development of animal models of serious bacterial infection. As a follow up to the FDA public workshop held on March 1, 2017, entitled “Current Status and Future Development of Animal Models of Serious Infections Caused by Acinetobacter baumannii and Pseudomonas aeruginosa,” FDA is holding this public workshop to discuss research results regarding the development of various animal models of serious infection funded by FDA, NIH, and BARDA, and to discuss ideas for future research in this area.[1]

Animal models of serious infection are useful to explore the activity of a new antibacterial drug and may be further developed to better predict whether the drug might be efficacious in humans, and thus potentially contribute to the selection of drugs, dosing regimens, and design elements for appropriate human clinical trials. Further developed models may be particularly useful in settings in which the use of concomitant or prior antibacterial drugs in clinical trials is common, such as development of a new antibacterial drug with activity against a single species.

II. Topics for Discussion at the Public Workshop

FDA is particularly interested in discussing challenges encountered in animal model development and ideas for future research. Discussions will focus on the following topic areas:

  • An overview of urinary tract infection, abdominal infection, and pneumonia animal models currently used in antibacterial drug development;
  • pharmacokinetic considerations in animal model development;
  • animal model resources and development supported by NIH;
  • progress and challenges in advancement of murine, rabbit, and porcine models of serious bacterial infections supported by FDA and BARDA; and
  • potential priorities for further research and development.

The Agency encourages health care providers, other U.S. Government Agencies, academic experts, industry, and other stakeholders to attend this public workshop.

III. Participating in the Public Workshop

Registration: Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public workshop must register online by March 2, 2020, 11:59 p.m. Eastern Time. To register, please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone by visiting https://www.eventbrite.com/​e/​advancing-animal-models-for-antibacterial-drug-development-tickets-73803340779.

Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. If time and space permit, onsite registration on the day of the public workshop will be provided beginning at 7:30 a.m. We will let registrants know if registration closes before the day of the public workshop.

If you need special accommodations due to a disability, please contact James Byrne (see FOR FURTHER INFORMATION CONTACT) no later than February 21, 2020.

Requests for Oral Presentations: During online registration you may indicate if you wish to present during a public comment session or participate in a specific 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, or submit requests for designated representatives to participate in the focused sessions. 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 by February 25, 2020. All requests to make oral presentations must be received by February 21, 2020. If selected for presentation, any presentation materials must be emailed to ONDPublicMTGSupport@fda.hhs.gov no later than March 2, 2020. No commercial or promotional material will be permitted to be presented or distributed at the public workshop.

Persons attending FDA's workshops are advised that FDA is not responsible for providing access to electrical outlets.

Streaming Webcast of the public workshop: This public workshop will also be webcast at the following website: https://collaboration.fda.gov/​amdworkshop.

If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/​common/​help/​en/​support/​meeting_​test.htm. To get a quick overview of the Connect Pro program, visit https://www.adobe.com/​go/​connectpro_​overview. FDA has verified the website addresses in this document, as of the date this document publishes in the Federal Register, but websites are subject to change over time.

Transcripts: Please be advised that as soon as a transcript of the public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. A link to the transcript will also be available on the internet at https://www.fda.gov/​drugs/​news-events-human-drugs/​advancing-animal-models-antibacterial-drug-development-03052020-03052020.

Start Signature

Dated: January 29, 2020.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.

End Signature End Supplemental Information

Footnotes

1.  We support the principles of the “3Rs,” to reduce, refine, and replace animal use in testing when feasible. We encourage sponsors to consult with us if it they wish to use a non-animal testing method that they believe is suitable, adequate, validated, and feasible. We will consider if such an alternative method could be assessed for equivalency to an animal test method.

Back to Citation

[FR Doc. 2020-02159 Filed 2-4-20; 8:45 am]

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