81 FR 78602 - Intent To Review a Study Data Standardization Plan Template; Notice of Availability; Establishment of a Public Docket; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 216 (November 8, 2016)

The Food and Drug Administration (FDA), Center for Drug Evaluation and Research, is establishing a public docket to collect comments related to a proposed Study Data Standardization Plan (SDSP) template. As part of FDA's ongoing collaboration with the Pharmaceutical Users Software Exchange (PhUSE), an independent, non- profit consortium addressing computational science issues, a PhUSE working group developed the PhUSE SDSP template. The purpose of this review is to evaluate the template and determine whether FDA will recommend its use either as is, or in a modified form, for regulatory submissions of study data. FDA is seeking public comment on the use of the PhUSE SDSP template for regulatory submissions.

[Federal Register Volume 81, Number 216 (Tuesday, November 8, 2016)]
[Notices]
[Pages 78602-78603]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-26913]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-3362]


Intent To Review a Study Data Standardization Plan Template; 
Notice of Availability; Establishment of a Public Docket; Request for 
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; request for comments.

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SUMMARY: The Food and Drug Administration (FDA), Center for Drug 
Evaluation and Research, is establishing a public docket to collect 
comments related to a proposed Study Data Standardization Plan (SDSP) 
template. As part of FDA's ongoing collaboration with the 
Pharmaceutical Users Software Exchange (PhUSE), an independent, non-
profit consortium addressing computational science issues, a PhUSE 
working group developed the PhUSE SDSP template. The purpose of this 
review is to evaluate the template and determine whether FDA will 
recommend its use either as is, or in a modified form, for regulatory 
submissions of study data. FDA is seeking public comment on the use of 
the PhUSE SDSP template for regulatory submissions.

DATES: Although you can comment on the PhUSE SDSP template at any time, 
to ensure that the Agency considers your comments in this review, 
please submit either electronic or written comments by January 9, 2017.

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

[[Page 78603]]

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-2016-N-3362 for ``Intent to Review a Study Data Standardization 
Plan Template.'' 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 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: Crystal Allard, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 21, Rm. 1518, Silver Spring, MD 20993-0002, 301-
796-8856, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is a participating member of PhUSE, an independent, non-profit 
consortium of academic, regulatory, non-profit, and private sector 
entities. PhUSE provides a global platform for the discussion of topics 
encompassing the work of biostatisticians, data managers, statistical 
programmers, and e-clinical information technology professionals, with 
the mission of providing an open, transparent, and collaborative forum 
to address computational science issues. As part of this collaboration, 
PhUSE working groups develop and periodically publish proposals for 
enhancing the review and analysis of human and animal study data 
submitted to regulatory agencies. You can learn more about PhUSE 
working groups at http://www.phuse.eu/cs-working-groups.aspx. (FDA has 
verified the Web site addresses as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over 
time.)
    In December 2014, FDA published the Study Data Technical 
Conformance Guide (the ``Guide,'' available at http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/default.htm), which 
contains technical recommendations to sponsors for the submission of 
animal and human study data and related information in a standardized 
electronic format. In section 2.1 of the Guide, FDA recommends that 
sponsors should include a plan (e.g., in the IND) describing the 
submission of standardized study data to FDA. FDA's Study Data 
Standards Resources Web page provides recommendations for preparing an 
SDSP (http://www.fda.gov/downloads/ForIndustry/DataStandards/StudyDataStandards/UCM447119.pdf).
    FDA now intends to review the PhUSE SDSP template, a deliverable of 
the working group effort described previously in this document, with 
the potential result that FDA could recommend the use of the template 
in its current form, or in a modified form, for use in the regulatory 
submission of study data in conformance with the Guide. FDA invites 
public comment on all matters regarding the use of the PhUSE SDSP 
template.

II. Electronic Access

    The PhUSE SDSP template is available at: http://www.phusewiki.org/wiki/images/e/ea/SDSP_Template.pdf.

    Dated: November 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26913 Filed 11-7-16; 8:45 am]
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