80 FR 81340 - Establishment of a Public Docket; Clinical Trial Designs in Emerging Infectious Diseases

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 249 (December 29, 2015)

The Food and Drug Administration (FDA) is establishing a public docket to receive input on clinical trial designs in emerging infectious diseases. Interested parties are invited to submit comments, supported by research and data, regarding clinical trial designs.

[Federal Register Volume 80, Number 249 (Tuesday, December 29, 2015)]
[Notices]
[Pages 81340-81341]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-32724]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-4170]


Establishment of a Public Docket; Clinical Trial Designs in 
Emerging Infectious Diseases

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of docket; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is establishing a 
public docket to receive input on clinical trial designs in emerging 
infectious diseases. Interested parties are invited to submit comments, 
supported by research and data, regarding clinical trial designs.

DATES: Submit either electronic or written comments on the collection 
of information by January 28, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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-2015-N-4170 for ``Clinical Trial Designs in Emerging Infectious 
Diseases.'' Received comments will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at http://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 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 http://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 background documents or 
the electronic and written/paper comments

[[Page 81341]]

received, go to http://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.

SUPPLEMENTARY INFORMATION: FDA held a workshop on ``Clinical Trial 
Designs in Emerging Infectious Diseases'' in partnership with the 
National Institute of Allergy and Infectious Diseases, the HHS Office 
of the Assistant Secretary for Preparedness and Response, and the 
Centers for Disease Control and Prevention as a step in collecting 
information. The objectives of the workshop were to: (1) Discuss the 
deployment of investigational products in the context of emerging 
infectious diseases, drawing on the lessons learned in the Ebola virus 
epidemic; (2) explore the strengths and weaknesses of different 
clinical trial designs for establishing the safety and efficacy of 
investigational products for the treatment and/or prevention of life-
threatening emerging infectious diseases (EID) in resource-limited 
settings from scientific, ethical, and operational perspectives; (3) 
identify areas of consensus and areas needing further discussion, with 
the goal of formulating acceptable options for the deployment of 
investigational products in clinical trials for future EIDs; and (4) 
discuss planning and other factors that can impact on the ability to 
establish clinical trials in a timely fashion to evaluate 
investigational therapies. The meeting agenda, transcripts, and web 
cast recordings are available on the FDA Web site at http://www.fda.gov/emergencypreparedness/counterterrorism/medicalcountermeasures/aboutmcmi/ucm466153.htm. The meeting agenda and 
transcripts will also be available in the docket.
    FDA is opening this docket to provide an avenue for the public to 
submit additional information that may be relevant to the design and 
conduct of clinical trials for establishing the safety and efficacy of 
investigational products for the treatment and/or prevention of life-
threatening emerging infectious diseases. Individuals submitting 
comments are specifically invited to address the scientific, ethical, 
and practical considerations that should be taken into account when 
designing and implementing clinical trials for future emerging 
infectious diseases in resource-limited settings.

    Dated: December 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-32724 Filed 12-28-15; 8:45 am]
 BILLING CODE 4164-01-P