Electronic Study Data Submission; Data Standards; Study Data Standardization Plan Recommendations, 28275-28276 [2015-11846]

Download as PDF Federal Register / Vol. 80, No. 95 / Monday, May 18, 2015 / Notices CDER anticipates providing four additional years of support up to the following amounts: absolutely essential element for ICH success. B. Research Objectives The program’s grant funds will support the ICH to develop a series of international guidelines for implementation according to each region’s requirements aimed at achieving the following: (1) Develop and register safe, effective, and high quality medicines in the most efficient and cost effective manner; (2) prevent unnecessary duplication of clinical trials and minimize the use of animal testing without compromising safety and effectiveness, and (3) provide public assurance that the rights, safety, and well-being of subjects are protected during clinical trials. The ICH aims to make information readily available on ICH, ICH activities, and ICH guidelines to any country or company that requests the information. Additionally, the organization promotes a mutual understanding of regional initiatives in order to facilitate harmonization processes related to ICH guidelines regionally and globally, and to strengthen the capacity of drug regulatory authorities and industry to utilize the guidelines. These objectives will be accomplished by bringing together representatives from both regulatory agencies and pharmaceutic industries from the three founding regions to establish guidelines. C. Eligibility Information asabaliauskas on DSK5VPTVN1PROD with NOTICES The following organization is eligible to apply: ICH. Within the ICH, the mission is to make recommendations towards achieving greater harmonization in the interpretation and application of technical guidelines and requirements for pharmaceutical product registration, thereby reducing or obviating duplication of testing carried out during the research and development of new human medicines. Leveraging its status as a neutral nonprofit entity focused on technical standards harmonization, the ICH aims to promote international harmonization of drug regulatory standards by bringing together representatives from both regulatory agencies and pharmaceutic industry to discuss and establish common guidelines. II. Award Information/Funds Available A. Award Amount FDA intends to fund one award, corresponding to a total of up to $500,000, for fiscal year (FY) 2016. Future year amounts will depend on annual appropriations, availability of funding, and awardee performance. VerDate Sep<11>2014 18:52 May 15, 2015 Jkt 235001 28275 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration FY 2017: $500,000 FY 2018: $500,000 FY 2019: $500,000 FY 2020: $500,000 [Docket No. FDA–2015–N–1377] Electronic Study Data Submission; Data Standards; Study Data Standardization Plan Recommendations B. Length of Support The support will be 1 year with the possibility of an additional 4 years of noncompetitive support. Continuation beyond the first year will be based on satisfactory performance during the preceding year, receipt of a noncompeting continuation application and available Federal FY appropriations. AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. 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 III. Electronic Application, referenced in the Study Data Technical Registration, and Submission Conformance Guide (Guide). The Guide supplements the guidance for industry Only electronic applications will be ‘‘Providing Regulatory Submissions in accepted. To submit an electronic Electronic Format—Standardized Study application in response to this FOA, Data’’ and provides specifications, applicants should first review the full recommendations, and general announcement located at https:// considerations on submitting www.grants.gov. (FDA has verified the standardized study data using FDAWeb site addresses throughout this supported data standards. The Guide document, but FDA is not responsible recommends that, for clinical and for any subsequent changes to the Web nonclinical studies, sponsors include a sites after this document publishes in plan that describes the submission of the Federal Register.) Search by standardized study data to FDA. The Funding Opportunity Number: RFA– proposed recommendations describe the FD–15–014. information that should be included in For all electronically submitted the Standardization Plan. The proposed applications, the following steps are recommendations for creating a required. Standardization Plan are posted on FDA’s Study Data Standards Resources • Step 1: Obtain a Dun and Bradstreet Web page at https://www.fda.gov/ (DUNS) Number forindustry/datastandards/ • Step 2: Register With System for studydatastandards/default.htm. Award Management (SAM) DATES: Although you can comment on • Step 3: Obtain Username & Password these recommendations at any time, to • Step 4: Authorized Organization ensure that the Agency considers your Representative (AOR) Authorization comments, please submit either electronic or written comments by July • Step 5: Track AOR Status 2, 2015. • Step 6: Register With Electronic ADDRESSES: Submit written requests for Research Administration (eRA) single copies of the recommendations to Commons the Division of Drug Information, Center for Drug Evaluation and Research, Food Steps 1 through 5, in detail, can be and Drug Administration, 10903 New found at https://www07.grants.gov/ applicants/organization_registration.jsp. Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– Step 6, in detail, can be found at https://commons.era.nih.gov/commons/ 0002; or the Office of Communication, registration/registrationInstructions.jsp. Outreach, and Development, Center for Biologics Evaluation and Research, After you have followed these steps, Food and Drug Administration, 10903 submit electronic applications to: New Hampshire Ave., Bldg. 71, Rm. https://www.grants.gov. 3128, Silver Spring, MD 20993–0002. Dated: May 11, 2015. Send one self-addressed adhesive label Leslie Kux, to assist that office in processing your Associate Commissioner for Policy. requests. [FR Doc. 2015–11847 Filed 5–15–15; 8:45 am] Submit electronic comments to https://www.regulations.gov. Submit BILLING CODE 4164–01–P PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 SUMMARY: E:\FR\FM\18MYN1.SGM 18MYN1 28276 Federal Register / Vol. 80, No. 95 / Monday, May 18, 2015 / Notices 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. 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: ronald.fitzmartin@fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: will be posted to the docket at https:// www.regulations.gov. III. Electronic Access Persons with access to the Internet may obtain the proposed recommendations at either https:// www.fda.gov/forindustry/ datastandards/studydatastandards/ default.htm or https:// 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 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 FDAsupported data standards; it is posted on FDA’s Study Data Standards Resources Web page at https://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., preinvestigational 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. asabaliauskas on DSK5VPTVN1PROD with NOTICES II. Comments Interested persons may submit either electronic comments regarding this document to https://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 VerDate Sep<11>2014 18:52 May 15, 2015 Jkt 235001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–D–1439] Adaptive Designs for Medical Device Clinical Studies; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Adaptive Designs for Medical Device Clinical Studies; Draft Guidance for Industry and Food and Drug Administration Staff.’’ This guidance provides sponsors and FDA staff with guidance on how to plan and implement adaptive designs for clinical studies when used in medical device development programs. An adaptive design for a medical device clinical study is defined as a clinical trial design that allows for prospectively planned modifications based on accumulating study data without undermining the trial’s integrity and validity. Adaptive designs, when properly implemented, can reduce resource requirements and/ or increase the chance of study success. This draft guidance is not final nor is it in effect at this time. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by August 17, 2015. ADDRESSES: An electronic copy of the guidance document is available for download from the Internet. See the SUMMARY: PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the draft guidance document entitled ‘‘Adaptive Designs for Medical Device Clinical Studies; Draft Guidance for Industry and Food and Drug Administration Staff’’ to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your request. Submit electronic comments on the draft guidance to https:// 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. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Greg Campbell, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2110, Silver Spring, MD 20993–0002, 301–796–5750. SUPPLEMENTARY INFORMATION: I. Background This guidance provides sponsors and FDA staff with guidance on how to plan and implement adaptive designs for clinical studies when used in medical device development programs. This document addresses adaptive designs for medical device clinical trials and is applicable to premarket medical device submissions including premarket approval applications, premarket notification (510(k)) submissions, de novo submissions (evaluation of automatic class III designation), humanitarian device exemption applications, and investigational device exemption submissions. This guidance can be applied throughout the clinical development program of a medical device, from feasibility studies to pivotal clinical trials. This guidance does not apply to clinical studies of combination products or codevelopment of a pharmaceutical product with an unapproved diagnostic test. II. Significance of Guidance This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on the adaptive design of clinical E:\FR\FM\18MYN1.SGM 18MYN1

Agencies

[Federal Register Volume 80, Number 95 (Monday, May 18, 2015)]
[Notices]
[Pages 28275-28276]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11846]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 https://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 https://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: ronald.fitzmartin@fda.hhs.gov.

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 https://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 https://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 https://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the proposed 
recommendations at either https://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm or https://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
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