[Federal Register Volume 82, Number 215 (Wednesday, November 8, 2017)]
[Notices]
[Pages 51847-51848]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24237]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-D-6100]
Intent To Review an Analysis Data Reviewer's Guide; Notice of
Availability, 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 (CDER), is establishing a public docket to
collect comments related to a proposed Analysis Data Reviewer's Guide
(ADRG) template. As part of FDA's ongoing collaboration with the
Pharmaceutical Users Software Exchange (PhUSE), an
[[Page 51848]]
independent, non-profit consortium addressing computational science
issues, a PhUSE working group developed the PhUSE ADRG 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 ADRG template for regulatory submissions.
DATES: Although you can comment on the PhUSE ADRG template at any time,
to ensure that the Agency considers your comments in this review,
please submit either electronic or written comments by January 8, 2018.
ADDRESSES: You may submit comments as follows:
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-2017-D-6100 for ``Intent to Review an Analysis Data Reviewer's
Guide Template.'' Received comments 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 of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/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.
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 https://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 2.3 of the Guide, FDA recommends that
sponsors should include a plan (e.g., in the New Drug Application
(NDA)) describing the submission of standardized study data to FDA. The
FDA's Analysis Data Resources Web page provides recommendations for
preparing an ADRG.
FDA now intends to review the PhUSE ADRG 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 ADRG
template.
II. Electronic Access
The PhUSE ADRG template is available at: http://www.phusewiki.org/wiki/index.php?title=Analysis_Data_Reviewer%27s_Guide.
Dated: November 1, 2017.
Lauren Silvis,
Chief of Staff.
[FR Doc. 2017-24237 Filed 11-7-17; 8:45 am]
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