[Federal Register Volume 80, Number 141 (Thursday, July 23, 2015)]
[Notices]
[Pages 43779-43780]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18027]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-2523]


Intent To Review a Study Data Reviewer's Guide Template

AGENCY: Food and Drug Administration, HHS.

[[Page 43780]]


ACTION: Notice of availability; request for comments.

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SUMMARY: The Food and Drug Administration (FDA), Center for Drug 
Evaluation and Research (CDER), is establishing a public docket to 
collect comments related to a proposed Study Data Reviewer's Guide 
(SDRG) 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 SRDG 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 SDRG template for regulatory submissions.

DATES: Although you can comment on the PhUSE SRDG template at any time, 
to ensure that the Agency considers your comments in this review, 
please submit either electronic or written comments by September 21, 
2015.

ADDRESSES: Submit written requests for single copies of the PhUSE SDRG 
template to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests.
    Submit electronic comments to http://www.regulations.gov. Submit 
written comments to the Division of Dockets Management (HFA-305), Food 
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 
20852. All comments should be identified with the docket number found 
in brackets in the heading of this document.

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.
    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 2.2 of the Guide, FDA recommends that 
each submitted study contain a Study Data Reviewer's Guide containing 
any special considerations or directions that may facilitate review of 
the study data. FDA notes in the Guide that the PhUSE SDRG template is 
an example of how to create an SDRG, but does not specifically 
recommend its use.
    FDA now intends to review the PhUSE SDRG template, a deliverable of 
the working group effort described above, 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 SDRG template. Interested 
persons may submit either electronic comments to http://www.regulations.gov or written comments to the Division of Dockets 
Management (see ADDRESSES). It is only necessary to send one set of 
comments. Identify comments with the docket number found in brackets in 
the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday, and will be posted to the docket at http://www.regulations.gov.

II. Electronic Access

    The PhUSE SDRG template is available online at http://www.phusewiki.org/wiki/index.php?title=Study_Data_Reviewer's_Guide.

    Dated: July 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18027 Filed 7-22-15; 8:45 am]
 BILLING CODE 4164-01-P