[Federal Register Volume 81, Number 8 (Wednesday, January 13, 2016)]
[Notices]
[Pages 1632-1633]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-00529]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-5106]


Clinical Outcome Assessment Compendium

AGENCY: Food and Drug Administration, HHS.

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

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the establishment of a docket to receive suggestions, recommendations, 
and comments from interested parties (including academic institutions, 
regulated industry, and patient groups) on our pilot ``Clinical Outcome 
Assessment Compendium'' (COA Compendium). FDA has developed a Web site 
that describes the purpose of the pilot COA Compendium and provides 
background information. Comments received on the pilot COA Compendium 
during its pilot phase will help FDA determine its utility, and may 
assist FDA in developing future iterations of the COA Compendium and 
identifying best methods for conveying COA Compendium information on 
FDA's Web site.

DATES: Submit either electronic or written comments by March 14, 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-5106 for ``Clinical Outcome Assessment Compendium.'' 
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

[[Page 1633]]

electronic and written/paper comments 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.

FOR FURTHER INFORMATION CONTACT: Nikunj B. Patel, Clinical Outcome 
Assessments Staff (formerly Study Endpoints and Labeling Development 
(SEALD)), Office of New Drugs, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 
6369, Silver Spring, MD 20993-0002, 240-402-6502, email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Capturing outcomes that are important to patients in clinical 
trials is a high priority for FDA. The pilot COA Compendium is part of 
FDA's efforts to foster patient-focused drug development.\1\ The COA 
Compendium is intended to facilitate communication and to provide 
clarity and transparency to drug developers and the research community 
by collating and summarizing clinical outcome assessment information 
for many different diseases and conditions into a single resource. It 
can be used as a starting point when considering how certain clinical 
outcome assessments might be utilized in clinical trials and will 
likely be most informative in early drug development. The public is 
referred to the following FDA Web site for additional background 
information, along with the pilot COA Compendium: http://www.fda.gov/COACompendium.
---------------------------------------------------------------------------

    \1\ The term drug, as used in this notice, refers to human drugs 
including biological products.
---------------------------------------------------------------------------

II. Establishment of a Docket and Request for Comments

    To help FDA determine the utility of the COA Compendium, develop 
future iterations of the COA Compendium, and identify best methods for 
conveying COA Compendium information on FDA's Web site, FDA is 
launching the pilot COA Compendium and soliciting public suggestions, 
recommendations, and comments for each aspect of the COA Compendium 
mentioned on the following FDA Web site: http://www.fda.gov/COACompendium. Specifically, FDA welcomes your comments concerning: (1) 
The utility of the COA Compendium; (2) the best approach for developing 
future iterations of it, including any suggested expansions of its 
scope; and (3) COA Compendium-related questions you would like FDA to 
address in its future communications. FDA will consider all comments 
submitted but will generally not respond directly to the person or 
organization submitting the comment.

    Dated: January 7, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-00529 Filed 1-12-16; 8:45 am]
BILLING CODE 4164-01-P