Document ID: FDA-2013-N-1277-0001
Agency: fda
Document Type: Notice
Title: Therapeutic Area Standards Initiative Project Plan; Availability
Posted Date: 2013-10-24T04:00Z

[Federal Register Volume 78, Number 206 (Thursday, October 24, 2013)]
[Notices]
[Pages 63481-63482]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-24909]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1277]

 Therapeutic Area Standards Initiative Project Plan; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the Therapeutic Area Standards Initiative Project Plan. 
This therapeutic area (TA) Project Plan will be the primary document 
for guiding all major aspects of FDA's multi-year initiative to develop 
and implement TA standards to support the regulatory review process for 
drugs and biologics. The TA Project Plan will be updated annually and 
made available for public comment.

DATES: Although you can comment on this TA Project Plan at any time, to 
ensure that the Agency considers your comment on this TA Project Plan 
before it begins work on the next version of the TA Project Plan, 
submit either electronic or written comments on the TA Project Plan by 
December 23, 2013.

ADDRESSES: Submit written requests for single copies of the TA Project 
Plan 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 or Office of 
Communication, Outreach and Development (HFM-40). Send one self-
addressed adhesive label to assist that

[[Page 63482]]

office in processing your requests. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the TA Project Plan.
    Submit electronic comments on the TA Project Plan 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.

FOR FURTHER INFORMATION CONTACT: Colleen Ratliffe, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1158, Silver Spring, MD 20993, email: 
CDERDataStandards@fda.hhs.gov; or Stephen Ripley, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 1401 Rockville 
Pike, Suite 200N, Rockville, MD 20852, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of the TA Project Plan. This TA 
Project Plan will be the primary document for guiding all major aspects 
of FDA's multi-year initiative to develop and implement TA standards to 
support the regulatory review process for drugs and biologics. Updated 
annually and made available for public comment, the plan will provide 
the overall management framework for addressing and accomplishing the 
PDUFA V objectives to develop and adopt clinical terminology standards 
for TAs.
    Standardized data elements and terminologies enable data from 
multiple trials to be grouped for analysis, and meta-analyses within 
and across drug classes. In 2011, in response to an urgent need to 
further standardize study data terminologies and concepts for efficacy 
analysis, FDA's Center for Drug Evaluation and Research (CDER) and 
Center for Biologics Evaluation and Research (CBER) compiled a 
prioritized list of disease and TAs and made it available on FDA's Web 
site.\1\ Several factors were considered in the identification and 
prioritization of these TAs: (1) Active investigational new drug 
applications (INDs), (2) existing standardization projects underway, 
and (3) industry input on drug development pipeline activity.
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    \1\ http://www.fda.gov/TherapeuticAreaStandards.
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    The Food and Drug Administration Safety and Innovation Act (FDASIA) 
reauthorized the Prescription Drug User Fee Act (PDUFA V) in July 2012. 
The PDUFA V Reauthorization Performance Goals and Procedures (Section 
XII) \2\ states that FDA will prepare a project plan for developing 
distinct TA terminology standards, using a public process that allows 
for stakeholder input through open standards development organizations.
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    \2\ http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf.
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    In November 2012, FDA requested public input relevant to study data 
standards by: (1) Convening a public meeting on November 5, 2012, 
entitled ``Regulatory New Drug Review: Solutions for Study Data 
Exchange Standards'' to receive input from stakeholders on the 
advantages and disadvantages of current and emerging alternatives for 
the exchange of regulated study data, and (2) issuing a notice in the 
August 14, 2012 Federal Register (77 FR 48491), informing the public of 
FDA's intent to prioritize and develop study data standards for 
identified TAs, and requesting public comment on the TA roadmap as well 
as recommendations on how the effort could be accomplished most 
efficiently. The TA Project Plan was developed based upon information 
from the November 5, 2012, public meeting and public comments submitted 
in response to the November 20, 2012, Federal Register notice on the 
prioritization of TAs.
    The TA standards should enable and enhance the ability to 
integrate, analyze, report, and share study data. As described in the 
TA Project Plan, CBER and CDER are actively collaborating with external 
stakeholders to support the development of these TA standards. 
Stakeholders are encouraged to engage in and support these data 
standardization efforts where possible, including providing feedback on 
the TA Project Plan.

II. Comments

    Interested persons may submit either electronic comments regarding 
this document 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.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm253101.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or http://www.regulations.gov.

    Dated: October 18, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-24909 Filed 10-23-13; 8:45 am]
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