Electronic Study Data Submission; Data Standards; Validation Rules for Study Data Tabulation Model Formatted Studies; Availability, 68890 [2014-27384]

Download as PDF 68890 Federal Register / Vol. 79, No. 223 / Wednesday, November 19, 2014 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN Number of respondents Activity Number of responses per respondent Average burden per response Total annual responses Total hours Adult Screener ..................................................... Study 1 (Adults) ................................................... Study 2 (Adults) ................................................... 24,000 1,800 600 1 1 1 24,000 1,800 600 0.03 (2 minutes) ............ 0.333 (20 minutes) ........ 0.333 (20 minutes) ........ 720 599 200 Total adult hours ........................................... ........................ ........................ ........................ ....................................... 1,519 Youth Screener .................................................... Study 3 (Youth) .................................................... 6,000 600 1 1 6,000 600 0.03 (2 minutes) ............ 0.333 (20 minutes) ........ 180 200 Total youth hours .......................................... ........................ ........................ ........................ ....................................... 380 Total Hours ............................................ ........................ ........................ ........................ ....................................... 1,899 FDA’s burden estimate is based on prior experience with research that is similar to this proposed study. Approximately 30,000 respondents will complete a screener to determine eligibility for participation in a study, estimated to take approximately 2 minutes (0.03 hours), for a total of 900 hours for screening activities. Three thousand respondents will complete a full study, estimated to last 20 minutes (0.333 hours), for a total of 999 hours for completion of both adult studies and one youth study. The estimated total hour burden of the collection of information is 1,899 hours. Dated: November 12, 2014. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2014–27283 Filed 11–18–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–1840] Electronic Study Data Submission; Data Standards; Validation Rules for Study Data Tabulation Model Formatted Studies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) is announcing the availability of a document entitled ‘‘Validation Rules for Study Data Tabulation Model (SDTM) Formatted Studies.’’ CDER is making this document available to improve the standardization and quality of clinical data submitted to CDER, as well as to improve the predictability of data quality and usefulness. mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:16 Nov 18, 2014 Jkt 235001 FOR FURTHER INFORMATION CONTACT: Office of Strategic Programs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1192, Silver Spring, MD 20993, email: edata@ fda.hhs.gov. CDER supports the regulatory submission of standardized clinical study data based on the Clinical Data Interchange Standards Consortium SDTM. Upon receipt of the data, CDER validates the data using a set of validation rules. The ‘‘Validation Rules for SDTM Formatted Studies’’ is an Excel file that provides a human readable description of a rule set for validation. Submitters of clinical study data can use this information to understand how FDA validates the data. The file is available on FDA’s Study Data Standards Resources Web page at http://www.fda.gov/ForIndustry/ DataStandards/StudyDataStandards/ default.htm. It contains a combination of conformance rules (i.e., how well the data conform to the standard) and business rules (i.e., quality checks; how well the data may support useful analysis). The rules may be updated periodically as new or updated validation rules are developed. The Change History tab will provide a descriptive change history of the document. SUPPLEMENTARY INFORMATION: Dated: November 14, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–27384 Filed 11–18–14; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–D–1120] Vaginal Microbicides: Development for the Prevention of Human Immunodeficiency Virus Infection; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Vaginal Microbicides: Development for the Prevention of HIV Infection.’’ The purpose of this guidance is to assist sponsors in all phases of development of vaginal microbicides, defined as vaginal drug products that prevent human immunodeficiency virus (HIV) acquisition. The guidance outlines the types of nonclinical studies and clinical trials recommended throughout the drug development process to support approval of vaginal microbicides. This guidance finalizes the draft guidance issued on November 23, 2012. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: Submit written requests for single copies of this guidance 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. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the guidance to http://www.regulations.gov. SUMMARY: E:\FR\FM\19NON1.SGM 19NON1

Agencies

[Federal Register Volume 79, Number 223 (Wednesday, November 19, 2014)]
[Notices]
[Page 68890]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-27384]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1840]


Electronic Study Data Submission; Data Standards; Validation 
Rules for Study Data Tabulation Model Formatted Studies; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration's (FDA) Center for Drug 
Evaluation and Research (CDER) is announcing the availability of a 
document entitled ``Validation Rules for Study Data Tabulation Model 
(SDTM) Formatted Studies.'' CDER is making this document available to 
improve the standardization and quality of clinical data submitted to 
CDER, as well as to improve the predictability of data quality and 
usefulness.

FOR FURTHER INFORMATION CONTACT: Office of Strategic Programs, Center 
for Drug Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 51, Rm. 1192, Silver Spring, MD 20993, email: 
edata@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: CDER supports the regulatory submission of 
standardized clinical study data based on the Clinical Data Interchange 
Standards Consortium SDTM. Upon receipt of the data, CDER validates the 
data using a set of validation rules. The ``Validation Rules for SDTM 
Formatted Studies'' is an Excel file that provides a human readable 
description of a rule set for validation. Submitters of clinical study 
data can use this information to understand how FDA validates the data. 
The file is available on FDA's Study Data Standards Resources Web page 
at http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/default.htm. It contains a combination of conformance rules (i.e., how 
well the data conform to the standard) and business rules (i.e., 
quality checks; how well the data may support useful analysis). The 
rules may be updated periodically as new or updated validation rules 
are developed. The Change History tab will provide a descriptive change 
history of the document.

    Dated: November 14, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-27384 Filed 11-18-14; 8:45 am]
BILLING CODE 4164-01-P