80_FR_28370 80 FR 28275 - Electronic Study Data Submission; Data Standards; Study Data Standardization Plan Recommendations

80 FR 28275 - Electronic Study Data Submission; Data Standards; Study Data Standardization Plan Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 95 (May 18, 2015)

Page Range28275-28276
FR Document2015-11846

The Food and Drug Administration (FDA) is announcing the availability of draft recommendations for preparing a Study Data Standardization Plan (Standardization Plan). The Standardization Plan is referenced in the Study Data Technical Conformance Guide (Guide). The Guide supplements the guidance for industry ``Providing Regulatory Submissions in Electronic Format--Standardized Study Data'' and provides specifications, recommendations, and general considerations on submitting standardized study data using FDA-supported data standards. The Guide recommends that, for clinical and nonclinical studies, sponsors include a plan that describes the submission of standardized study data to FDA. The proposed recommendations describe the information that should be included in the Standardization Plan. The proposed recommendations for creating a Standardization Plan are posted on FDA's Study Data Standards Resources Web page at http://www.fda.gov/ forindustry/datastandards/studydatastandards/default.htm.

Federal Register, Volume 80 Issue 95 (Monday, May 18, 2015) 
[Federal Register Volume 80, Number 95 (Monday, May 18, 2015)]
[Notices]
[Pages 28275-28276]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-11846]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-1377]


Electronic Study Data Submission; Data Standards; Study Data 
Standardization Plan Recommendations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of draft recommendations for preparing a Study Data 
Standardization Plan (Standardization Plan). The Standardization Plan 
is referenced in the Study Data Technical Conformance Guide (Guide). 
The Guide supplements the guidance for industry ``Providing Regulatory 
Submissions in Electronic Format--Standardized Study Data'' and 
provides specifications, recommendations, and general considerations on 
submitting standardized study data using FDA-supported data standards. 
The Guide recommends that, for clinical and nonclinical studies, 
sponsors include a plan that describes the submission of standardized 
study data to FDA. The proposed recommendations describe the 
information that should be included in the Standardization Plan. The 
proposed recommendations for creating a Standardization Plan are posted 
on FDA's Study Data Standards Resources Web page at http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm.

DATES: Although you can comment on these recommendations at any time, 
to ensure that the Agency considers your comments, please submit either 
electronic or written comments by July 2, 2015.

ADDRESSES: Submit written requests for single copies of the 
recommendations to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 
20993-0002; or the Office of Communication, Outreach, and Development, 
Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, 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

[[Page 28276]]

written comments to the Division of Dockets Management (HFA-305), Food 
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 
20852. See the SUPPLEMENTARY INFORMATION section for electronic access 
to the draft recommendations for preparing the Standardization Plan.

FOR FURTHER INFORMATION CONTACT: Ron Fitzmartin, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1192, Silver Spring, MD 20993-002, 301-
796-5333, email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of draft recommendations for 
preparing the Standardization Plan. The Standardization Plan is 
referenced in the Guide. The Guide supplements the guidance for 
industry ``Providing Regulatory Submissions in Electronic Format--
Standardized Study Data'' and provides specifications, recommendations, 
and general considerations on submitting standardized study data using 
FDA-supported data standards; it is posted on FDA's Study Data 
Standards Resources Web page at http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm.
    The Guide recommends that, for clinical and nonclinical studies, 
sponsors include a plan that describes the submission of standardized 
study data to FDA. The Standardization Plan will assist FDA in 
identifying potential data standardization issues early in the 
development program (e.g., pre-investigational new drug application 
stage). The draft recommendations describe the information that should 
be included in the Standardization Plan. The recommendations include, 
but are not limited to, the following: (1) General sponsor information, 
(2) product information, (3) list of completed studies and standards, 
and (4) list of planned studies and standards.

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 proposed 
recommendations at either http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm or http://www.regulations.gov.

    Dated: May 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-11846 Filed 5-15-15; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 95 / Monday, May 18, 2015 / Notices 28275 absolutely essential element for ICH CDER anticipates providing four DEPARTMENT OF HEALTH AND success. additional years of support up to the HUMAN SERVICES following amounts: B. Research Objectives Food and Drug Administration The program’s grant funds will FY 2017: $500,000 FY 2018: $500,000 [Docket No. FDA–2015–N–1377] support the ICH to develop a series of international guidelines for FY 2019: $500,000 Electronic Study Data Submission; implementation according to each Data Standards; Study Data region’s requirements aimed at FY 2020: $500,000 Standardization Plan achieving the following: (1) Develop and B. Length of Support Recommendations register safe, effective, and high quality medicines in the most efficient and cost The support will be 1 year with the AGENCY: Food and Drug Administration, effective manner; (2) prevent possibility of an additional 4 years of HHS. unnecessary duplication of clinical noncompetitive support. Continuation ACTION: Notice; request for comments. trials and minimize the use of animal beyond the first year will be based on testing without compromising safety satisfactory performance during the The Food and Drug SUMMARY: and effectiveness, and (3) provide preceding year, receipt of a Administration (FDA) is announcing the public assurance that the rights, safety, noncompeting continuation application availability of draft recommendations and well-being of subjects are protected and available Federal FY for preparing a Study Data during clinical trials. appropriations. Standardization Plan (Standardization The ICH aims to make information Plan). The Standardization Plan is III. Electronic Application, readily available on ICH, ICH activities, referenced in the Study Data Technical Registration, and Submission and ICH guidelines to any country or Conformance Guide (Guide). The Guide company that requests the information. Only electronic applications will be supplements the guidance for industry Additionally, the organization promotes accepted. To submit an electronic ‘‘Providing Regulatory Submissions in a mutual understanding of regional application in response to this FOA, Electronic Format—Standardized Study initiatives in order to facilitate applicants should first review the full Data’’ and provides specifications, harmonization processes related to ICH announcement located at http:// recommendations, and general guidelines regionally and globally, and www.grants.gov. (FDA has verified the considerations on submitting to strengthen the capacity of drug Web site addresses throughout this standardized study data using FDA- regulatory authorities and industry to document, but FDA is not responsible supported data standards. The Guide utilize the guidelines. These objectives for any subsequent changes to the Web recommends that, for clinical and will be accomplished by bringing sites after this document publishes in nonclinical studies, sponsors include a together representatives from both the Federal Register.) Search by plan that describes the submission of regulatory agencies and pharmaceutic Funding Opportunity Number: RFA– standardized study data to FDA. The industries from the three founding FD–15–014. proposed recommendations describe the regions to establish guidelines. information that should be included in For all electronically submitted the Standardization Plan. The proposed C. Eligibility Information applications, the following steps are recommendations for creating a The following organization is eligible required. Standardization Plan are posted on to apply: ICH. Within the ICH, the • Step 1: Obtain a Dun and Bradstreet FDA’s Study Data Standards Resources mission is to make recommendations (DUNS) Number Web page at http://www.fda.gov/ towards achieving greater • Step 2: Register With System for forindustry/datastandards/ harmonization in the interpretation and Award Management (SAM) studydatastandards/default.htm. application of technical guidelines and DATES: Although you can comment on requirements for pharmaceutical • Step 3: Obtain Username & Password these recommendations at any time, to product registration, thereby reducing or • Step 4: Authorized Organization ensure that the Agency considers your obviating duplication of testing carried Representative (AOR) Authorization comments, please submit either out during the research and • Step 5: Track AOR Status electronic or written comments by July development of new human medicines. 2, 2015. Leveraging its status as a neutral • Step 6: Register With Electronic Research Administration (eRA) ADDRESSES: Submit written requests for nonprofit entity focused on technical single copies of the recommendations to standards harmonization, the ICH aims Commons the Division of Drug Information, Center to promote international harmonization Steps 1 through 5, in detail, can be for Drug Evaluation and Research, Food of drug regulatory standards by bringing found at http://www07.grants.gov/ and Drug Administration, 10903 New together representatives from both applicants/organization_registration.jsp. Hampshire Ave., Hillandale Building, regulatory agencies and pharmaceutic Step 6, in detail, can be found at 4th Floor, Silver Spring, MD 20993– industry to discuss and establish https://commons.era.nih.gov/commons/ 0002; or the Office of Communication, common guidelines. registration/registrationInstructions.jsp. Outreach, and Development, Center for After you have followed these steps, Biologics Evaluation and Research, asabaliauskas on DSK5VPTVN1PROD with NOTICES II. Award Information/Funds Available submit electronic applications to: Food and Drug Administration, 10903 A. Award Amount http://www.grants.gov. New Hampshire Ave., Bldg. 71, Rm. FDA intends to fund one award, Dated: May 11, 2015. 3128, Silver Spring, MD 20993–0002. corresponding to a total of up to Send one self-addressed adhesive label Leslie Kux, $500,000, for fiscal year (FY) 2016. to assist that office in processing your Future year amounts will depend on Associate Commissioner for Policy. requests. annual appropriations, availability of [FR Doc. 2015–11847 Filed 5–15–15; 8:45 am] Submit electronic comments to funding, and awardee performance. BILLING CODE 4164–01–P http://www.regulations.gov. Submit VerDate Sep<11>2014 18:52 May 15, 2015 Jkt 235001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\18MYN1.SGM 18MYN1

28276 Federal Register / Vol. 80, No. 95 / Monday, May 18, 2015 / Notices written comments to the Division of will be posted to the docket at http:// SUPPLEMENTARY INFORMATION section for Dockets Management (HFA–305), Food www.regulations.gov. information on electronic access to the and Drug Administration, 5630 Fishers guidance. Submit written requests for a III. Electronic Access Lane, Rm. 1061, Rockville, MD 20852. single hard copy of the draft guidance See the SUPPLEMENTARY INFORMATION Persons with access to the Internet document entitled ‘‘Adaptive Designs section for electronic access to the draft may obtain the proposed for Medical Device Clinical Studies; recommendations for preparing the recommendations at either http:// Draft Guidance for Industry and Food Standardization Plan. www.fda.gov/forindustry/ and Drug Administration Staff’’ to the datastandards/studydatastandards/ Office of the Center Director, Guidance FOR FURTHER INFORMATION CONTACT: Ron default.htm or http:// and Policy Development, Center for Fitzmartin, Center for Drug Evaluation www.regulations.gov. Devices and Radiological Health, Food and Research, Food and Drug Administration, 10903 New Hampshire Dated: May 11, 2015. and Drug Administration, 10903 New Ave., Bldg. 51, Rm. 1192, Silver Spring, Leslie Kux, Hampshire Ave., Bldg. 66, Rm. 5431, MD 20993–002, 301–796–5333, email: Associate Commissioner for Policy. Silver Spring, MD 20993–0002. Send ronald.fitzmartin@fda.hhs.gov. [FR Doc. 2015–11846 Filed 5–15–15; 8:45 am] one self-addressed adhesive label to assist that office in processing your BILLING CODE 4164–01–P SUPPLEMENTARY INFORMATION: request. I. Background Submit electronic comments on the DEPARTMENT OF HEALTH AND draft guidance to http:// FDA is announcing the availability of HUMAN SERVICES www.regulations.gov. Submit written draft recommendations for preparing the comments to the Division of Dockets Standardization Plan. The Food and Drug Administration Management (HFA–305), Food and Drug Standardization Plan is referenced in Administration, 5630 Fishers Lane, Rm. the Guide. The Guide supplements the [Docket No. FDA–2015–D–1439] 1061, Rockville, MD 20852. Identify guidance for industry ‘‘Providing Adaptive Designs for Medical Device comments with the docket number Regulatory Submissions in Electronic Clinical Studies; Draft Guidance for found in brackets in the heading of this Format—Standardized Study Data’’ and Industry and Food and Drug document. provides specifications, Administration Staff; Availability FOR FURTHER INFORMATION CONTACT: Greg recommendations, and general Campbell, Center for Devices and considerations on submitting AGENCY: Food and Drug Administration, Radiological Health, Food and Drug standardized study data using FDA- HHS. Administration, 10903 New Hampshire supported data standards; it is posted on ACTION: Notice. Ave., Bldg. 66, Rm. 2110, Silver Spring, FDA’s Study Data Standards Resources MD 20993–0002, 301–796–5750. Web page at http://www.fda.gov/ SUMMARY: The Food and Drug Administration (FDA) is announcing the SUPPLEMENTARY INFORMATION: forindustry/datastandards/ studydatastandards/default.htm. availability of the draft guidance I. Background The Guide recommends that, for entitled ‘‘Adaptive Designs for Medical Device Clinical Studies; Draft Guidance This guidance provides sponsors and clinical and nonclinical studies, FDA staff with guidance on how to plan sponsors include a plan that describes for Industry and Food and Drug Administration Staff.’’ This guidance and implement adaptive designs for the submission of standardized study clinical studies when used in medical data to FDA. The Standardization Plan provides sponsors and FDA staff with guidance on how to plan and implement device development programs. This will assist FDA in identifying potential document addresses adaptive designs data standardization issues early in the adaptive designs for clinical studies when used in medical device for medical device clinical trials and is development program (e.g., pre- applicable to premarket medical device investigational new drug application development programs. An adaptive design for a medical device clinical submissions including premarket stage). The draft recommendations approval applications, premarket describe the information that should be study is defined as a clinical trial design that allows for prospectively planned notification (510(k)) submissions, de included in the Standardization Plan. novo submissions (evaluation of The recommendations include, but are modifications based on accumulating study data without undermining the automatic class III designation), not limited to, the following: (1) General humanitarian device exemption sponsor information, (2) product trial’s integrity and validity. Adaptive designs, when properly implemented, applications, and investigational device information, (3) list of completed exemption submissions. This guidance studies and standards, and (4) list of can reduce resource requirements and/ or increase the chance of study success. can be applied throughout the clinical planned studies and standards. development program of a medical This draft guidance is not final nor is it II. Comments in effect at this time. device, from feasibility studies to pivotal clinical trials. This guidance Interested persons may submit either DATES: Although you can comment on does not apply to clinical studies of electronic comments regarding this any guidance at any time (see 21 CFR combination products or codevelopment document to http://www.regulations.gov 10.115(g)(5)), to ensure that the Agency of a pharmaceutical product with an or written comments to the Division of considers your comment of this draft asabaliauskas on DSK5VPTVN1PROD with NOTICES unapproved diagnostic test. Dockets Management (see ADDRESSES). It guidance before it begins work on the is only necessary to send one set of final version of the guidance, submit II. Significance of Guidance comments. Identify comments with the either electronic or written comments This draft guidance is being issued docket number found in brackets in the on the draft guidance by August 17, consistent with FDA’s good guidance heading of this document. Received 2015. practices regulation (21 CFR 10.115). comments may be seen in the Division ADDRESSES: An electronic copy of the The draft guidance, when finalized, will of Dockets Management between 9 a.m. guidance document is available for represent the current thinking of FDA and 4 p.m., Monday through Friday, and download from the Internet. See the on the adaptive design of clinical VerDate Sep<11>2014 18:52 May 15, 2015 Jkt 235001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\18MYN1.SGM 18MYN1


Document Created: 2015-12-16 07:39:41
Document Modified: 2015-12-16 07:39:41
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice; request for comments.
DatesAlthough you can comment on these recommendations at any time, to ensure that the Agency considers your comments, please submit either electronic or written comments by July 2, 2015.
ContactRon Fitzmartin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1192, Silver Spring, MD 20993-002, 301- 796-5333, email: [email protected]
FR Citation80 FR 28275 
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