82 FR 51847 - Intent To Review an Analysis Data Reviewer's Guide; Notice of Availability, Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 215 (November 8, 2017)

Page Range		51847-51848
FR Document		2017-24237

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 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.

Federal Register, Volume 82 Issue 215 (Wednesday, November 8, 2017)

[Federal Register Volume 82, Number 215 (Wednesday, November 8, 2017)]
[Notices]
[Pages 51847-51848]
From the Federal Register Online  [www.thefederalregister.org]
[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.thefederalregister.org/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]
 BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 215 / Wednesday, November 8, 2017 / Notices 51847

designation and provides examples of requirements for preparing an descriptions of clinical safety and
surrogate endpoints and intermediate investigational new drug (IND), new efficacy trials not conducted under an
clinical endpoints used to support drug application (NDA), or biologic IND (e.g., foreign studies) and
accelerated approval. license application (BLA). If such information to support a request for
The information collection resulting information has already been submitted accelerated approval. If such
from requests for priority review to the Agency, the information may be information has already been submitted
designation and breakthrough therapy summarized in the fast track designation to FDA, the information may be
designation is set forth in rows 1 and 2 request. A designation request should summarized in the premeeting package.
of table 1 and is approved by the Office include, where applicable, additional The Agency estimates the total annual
of Management and Budget (OMB) information not specified elsewhere by number of respondents submitting
under control number 0910–0765. The statute or regulation. For example, requests for fast track designation is
information collection resulting from additional information may be needed approximately 140, and the number of
requests for accelerated approval is to show that a product has the potential requests received is approximately 187
approved by OMB under control to address an unmet medical need annually. FDA estimates that the
numbers 0910–0001 and 0910–0338. where an approved therapy exists for number of hours needed to prepare a
The provisions of the guidance the serious or life-threatening condition request for fast track designation is
relating to fast track development and to be treated. Such information may approximately 60 hours per request
other issues such as serious condition include clinical data, published reports, (row 3 in table 1).
and unmet medical need replace the summaries of data and reports, and a list
guidance entitled ‘‘Fast Track Drug Of the requests for fast track
of references. The amount of
Development Programs—Designation, information and discussion in a designation made per year, the Agency
Development, and Application Review.’’ designation request need not be granted approximately 132 requests
Consequently, the information voluminous, but it should be sufficient from 107 respondents, and for each of
collection resulting from the guidance to permit a reviewer to assess whether these granted requests, a premeeting
‘‘Fast Track Drug Development the criteria for fast track designation package was submitted to the Agency.
Programs—Designation, Development, have been met. FDA estimates that the preparation
and Application Review’’ (OMB control After the Agency makes a fast track hours are approximately 100 hours per
number 0910–0389) is now being designation, a sponsor or applicant may premeeting package (row 4 in table 1).
incorporated into OMB control number submit a premeeting package that may The guidance also refers to previously
0910–0765 (guidance for industry include additional information approved collections of information
‘‘Expedited Programs for Serious supporting a request to participate in found in FDA regulations. The
Conditions—Drugs and Biologics’’). certain fast track programs. The collections of information in 21 CFR
A sponsor or applicant who seeks fast premeeting package serves as 202.1 and 21 CFR parts 314, and 601,
track designation is required to submit background information for the meeting and sections 505(a), 506(a)(1), 735, and
a request to the Agency showing that the and should support the intended 736 of the Federal Food, Drug, and
drug product: (1) Is intended for a objectives of the meeting. As with the Cosmetic Act (21 U.S.C. 355(a),
serious or life-threatening condition and request for fast track designation, the 356(a)(1), 379(g), and 379(h)) have been
(2) has the potential to address an Agency expects that most sponsors or approved under OMB control numbers
unmet medical need. The Agency applicants will have gathered such 0910–0686, 0910–0001, 0910–0338,
expects that most information to information to meet existing 0910–0014, and 0910–0297.
support a designation request will have requirements for preparing an IND, FDA estimates the burden of this
been gathered under existing NDA, or BLA. These may include collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Guidance for Industry: Expedited Programs for Serious Number of Number of Total annual Average
responses per burden per Total hours
Conditions—Drugs and Biologics respondents responses
respondent response

Priority review designation request ...................................... 48 1.7 82 30 2,400
Breakthrough therapy designation request .......................... 87 1.29 113 70 7,910
Fast track designation request ............................................ 140 1.33 187 60 11,220
Fast track premeeting packages ......................................... 107 1.23 132 100 13,200

Total .............................................................................. ........................ ........................ ........................ ........................ 34,730
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The data pertaining to fast track DEPARTMENT OF HEALTH AND ACTION:Notice of availability; request
designation (last two rows of table 1) HUMAN SERVICES for comments.
has changed since the last OMB
approval. Food and Drug Administration SUMMARY: The Food and Drug
Administration (FDA), Center for Drug
ethrower on DSK3G9T082PROD with NOTICES

Dated: November 2, 2017. [Docket No. FDA–2017–D–6100] Evaluation and Research (CDER), is
Anna K. Abram, establishing a public docket to collect
Intent To Review an Analysis Data
Deputy Commissioner for Policy, Planning, Reviewer’s Guide; Notice of comments related to a proposed
Legislation, and Analysis.
Availability, Request for Comments Analysis Data Reviewer’s Guide (ADRG)
[FR Doc. 2017–24296 Filed 11–7–17; 8:45 am] template. As part of FDA’s ongoing
BILLING CODE 4164–01–P AGENCY: Food and Drug Administration, collaboration with the Pharmaceutical
HHS. Users Software Exchange (PhUSE), an

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Document Created: 2017-11-08 01:20:55
Document Modified: 2017-11-08 01:20:55

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability; request for comments.
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.
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]
FR Citation		82 FR 51847

82 FR 51847 - Intent To Review an Analysis Data Reviewer's Guide; Notice of Availability, Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 215 (November 8, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration