80 FR 50014 - Electronic Study Data Submission; Data Standards; Support for Study Data Tabulation Model Implementation Guide Version 3.2
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 159 (August 18, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 159 (August 18, 2015)
| Page Range | 50014-50015 | |
| FR Document | 2015-20316 |
[Federal Register Volume 80, Number 159 (Tuesday, August 18, 2015)] [Notices] [Pages 50014-50015] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-20316] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-2853] Electronic Study Data Submission; Data Standards; Support for Study Data Tabulation Model Implementation Guide Version 3.2 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) are announcing support for the 3.2 version (see section II. Exceptions) of Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model Implementation Guide (SDTM IG 3.2), an update to the FDA Data Standards Catalog (Catalog), and availability of validation rules for the 3.2 version. SDTM IG 3.2 has been available from CDISC since December 2013. FDA is encouraging sponsors and applicants to use SDTM IG 3.2 (see section II. Exceptions) in investigational study data provided in regulatory submissions to CBER and to CDER. 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, [[Page 50015]] MD 20993-002, 301-796-5333, email: ronald.fitzmartin@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background On December 17, 2014, FDA published a final guidance for industry entitled ``Providing Regulatory Submissions in Electronic Format-- Standardized Study Data'' (eStudy Data) posted on FDA's Study Data Standards Resources Web page at http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm. The eStudy Data guidance implements the electronic submission requirements of section 745A(a) of the FD&C Act (21 U.S.C. 379k-1) for study data contained in new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and investigational new drug applications (INDs) to CBER or CDER by specifying the format for electronic submissions. The initial timetable for the implementation of electronic submission requirements for study data is December 17, 2016 (24 months after issuance of final guidance for NDAs, BLAs, ANDAs, and 36 months for INDs). The eStudy Data guidance states that a Federal Register notice will specify the transition date for all version updates (with the month and day for the transition date corresponding to March 15). The transition date for support (see section II. Exceptions) of the 3.2 version of CDISC STDM IG is March 15, 2017. Although SDTM IG version 3.2 is supported as of this Federal Register notice and sponsors or applicants are encouraged to begin using it, the new version will only be required in submissions for studies that start after March 15, 2018. The Catalog will list March 15, 2018, as the ``date requirement begins.'' When multiple versions of an FDA-supported standard are listed in the Catalog, sponsors or applicants can select a version to use. II. Exceptions The following SDTM IG 3.2 domains have not completed testing and acceptance and are not supported at this time: Death Details and Exposure as Collected. The therapeutic area (TA) standards (http://www.cdisc.org/) that are included in SDTM IG 3.2 have not completed testing and acceptance and are not supported at this time. The specific domain and the TA standard are listed in the table that follows: ------------------------------------------------------------------------ SDTM IG 3.2 Domain TA User guide ------------------------------------------------------------------------ 1. Healthcare Encounters.......... Cardiovascular Studies, 1.0; Polycystic Kidney Disease, 1.0; Asthma, 1.0. 2. Microscopic Findings........... Tuberculosis, 1.0; Parkinson's, 1.0. 3. Morphology..................... Cardiovascular Studies, 1.0; Parkinson's, 1.0; Polycystic Kidney Disease, 1.0; Alzheimer's, 1.0; Multiple Sclerosis, 1.0. 4. Procedures..................... Cardiovascular Studies, 1.0; Polycystic Kidney Disease, 1.0; Alzheimer's, 1.0. 5. Reproductive System............ Polycystic Kidney Disease, 1.0. 6. Disease Response............... Tuberculosis, 1.0. 7. Skin Response.................. Asthma, 1.0. ------------------------------------------------------------------------ Sponsors and applicants with questions on how to implement the FDA- supported study data standards should contact and work with FDA technical staff. For questions, contact CDER at cder-edata@fda.hhs.gov or CBER at cber.cdisc@fda.hhs.gov. III. 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. IV. 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: August 12, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-20316 Filed 8-17-15; 8:45 am] BILLING CODE 4164-01-P
![50014 Federal Register / Vol. 80, No. 159 / Tuesday, August 18, 2015 / Notices
ADDRESSES: Submit written requests for final rule requiring that certain III. Comments
single copies of the guidance to the postmarketing safety reports for human Interested persons may submit either
Office of Communication, Outreach and drug and biological products, including electronic comments regarding this
Development, Center for Biologics vaccines, be submitted to FDA in an document to http://www.regulations.gov
Evaluation and Research (CBER), Food electronic format that the Agency can or written comments to the Division of
and Drug Administration, 10903 New process, review, and archive. The Dockets Management (see ADDRESSES). It
Hampshire Ave., Bldg. 71, Rm. 3128, guidance is intended to help those is only necessary to send one set of
Silver Spring, MD 20993–0002. Send applicants required to submit comments. Identify comments with the
one self-addressed adhesive label to postmarketing safety reports involving docket number found in brackets in the
assist the office in processing your vaccine products to comply with the heading of this document. Received
requests. The guidance may also be final rule. comments may be seen in the Division
obtained by mail by calling CBER at In the Federal Register of July 18, of Dockets Management between 9 a.m.
1–800–835–4709 or 240–402–8010. See 2014 (79 FR 42022), FDA announced the and 4 p.m., Monday through Friday, and
the SUPPLEMENTARY INFORMATION section availability of the draft guidance of the will be posted to the docket at http://
for electronic access to the guidance same title dated July 2014. FDA www.regulations.gov.
document. received a few comments on the draft
Submit electronic comments on the guidance and those comments were IV. Electronic Access
guidance to http://www.regulations.gov. considered as the guidance was Persons with access to the Internet
Submit written comments to the finalized. The guidance includes may obtain the guidance at either http://
Division of Dockets Management (HFA– changes to clarify the reporting www.fda.gov/BiologicsBloodVaccines/
305), Food and Drug Administration, requirements and technical process for GuidanceComplianceRegulatory
5630 Fishers Lane, Rm. 1061, Rockville, submitting reports to VAERS. In Information/Guidances/default.htm or
MD 20852. addition, editorial changes were made http://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Paul to improve clarity. The guidance Dated: August 12, 2015.
E. Levine, Jr., Center for Biologics announced in this notice finalizes the
Leslie Kux,
Evaluation and Research, Food and draft guidance dated July 2014 and
Associate Commissioner for Policy.
Drug Administration, 10903 New supersedes the document entitled
‘‘Guidance for Industry: How to [FR Doc. 2015–20312 Filed 8–17–15; 8:45 am]
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240– Complete the Vaccine Adverse Event BILLING CODE 4164–01–P
402–7911. Report System Form (VAERS–1)’’ dated
SUPPLEMENTARY INFORMATION: September 1998.
DEPARTMENT OF HEALTH AND
This guidance is being issued
I. Background HUMAN SERVICES
consistent with FDA’s good guidance
FDA is announcing the availability of practices regulation (21 CFR 10.115). Food and Drug Administration
a document entitled ‘‘Providing The guidance represents the current
Submissions in Electronic Format— thinking of FDA on Providing [Docket No. FDA–2015–N–2853]
Postmarketing Safety Reports for Submissions in Electronic Format—
Electronic Study Data Submission;
Vaccines; Guidance for Industry.’’ The Postmarketing Safety Reports for
Data Standards; Support for Study
guidance document provides Vaccines. It does not establish any rights
Data Tabulation Model Implementation
information and recommendations for any person and is not binding on
Guide Version 3.2
pertaining to the electronic submission FDA or the public. You can use an
of postmarketing safety reports alternative approach if it satisfies the AGENCY: Food and Drug Administration,
involving vaccine products marketed for requirements of the applicable statutes HHS.
human use with approved BLAs, and regulations. ACTION: Notice.
including ICSRs and ICSR attachments,
II. Paperwork Reduction Act of 1995 SUMMARY: The Center for Biologics
into VAERS. VAERS is a national
vaccine safety surveillance program This guidance refers to previously Evaluation and Research (CBER) and the
established in response to the National approved collections of information Center for Drug Evaluation and Research
Childhood Vaccine Injury Act of 1986, found in FDA regulations. These (CDER) are announcing support for the
which requires health professionals and collections of information are subject to 3.2 version (see section II. Exceptions)
vaccine manufacturers to report specific review by the Office of Management and of Clinical Data Interchange Standards
adverse events that occur after the Budget (OMB) under the Paperwork Consortium (CDISC) Study Data
administration of routinely Reduction Act of 1995 (44 U.S.C. 3501– Tabulation Model Implementation
recommended vaccines. VAERS is co- 3520). The collections of information in Guide (SDTM IG 3.2), an update to the
sponsored by CDC and FDA. The 21 CFR part 310 and part 314 have been FDA Data Standards Catalog (Catalog),
guidance is applicable to vaccine approved under OMB control number and availability of validation rules for
products marketed for human use with 0910–0230. The collections of the 3.2 version. SDTM IG 3.2 has been
approved BLAs for which CBER has information in 21 CFR 310.305(e)(2), available from CDISC since December
regulatory responsibility. The guidance 314.80(g)(2), 329.100(c)(2), and 2013. FDA is encouraging sponsors and
does not apply to any other biological 600.80(h)(2) (Form FDA 3500A), have applicants to use SDTM IG 3.2 (see
asabaliauskas on DSK5VPTVN1PROD with NOTICES
product. Postmarketing ICSRs and ICSR been approved under OMB control section II. Exceptions) in investigational
attachments for biological products, number 0910–0770. The collection of study data provided in regulatory
which are not addressed by the information in 21 CFR part 600 is submissions to CBER and to CDER.
guidance, are processed into the FDA approved under OMB control number FOR FURTHER INFORMATION CONTACT: Ron
Adverse Event Reporting System 0910–0308. The collection of Fitzmartin, Center for Drug Evaluation
database. information in Form FDA 3500A is and Research, Food and Drug
In the Federal Register of June 10, approved under OMB control number Administration, 10903 New Hampshire
2014 (79 FR 33072), FDA published a 0910–0291. Ave., Bldg. 51, Rm. 1192, Silver Spring,
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![Federal Register / Vol. 80, No. 159 / Tuesday, August 18, 2015 / Notices 50015
MD 20993–002, 301–796–5333, email: new drug applications (INDs) to CBER submissions for studies that start after
ronald.fitzmartin@fda.hhs.gov. or CDER by specifying the format for March 15, 2018. The Catalog will list
SUPPLEMENTARY INFORMATION: electronic submissions. The initial March 15, 2018, as the ‘‘date
timetable for the implementation of requirement begins.’’ When multiple
I. Background electronic submission requirements for versions of an FDA-supported standard
On December 17, 2014, FDA study data is December 17, 2016 (24 are listed in the Catalog, sponsors or
published a final guidance for industry months after issuance of final guidance applicants can select a version to use.
entitled ‘‘Providing Regulatory for NDAs, BLAs, ANDAs, and 36
Submissions in Electronic Format— months for INDs). The eStudy Data II. Exceptions
Standardized Study Data’’ (eStudy Data) guidance states that a Federal Register
posted on FDA’s Study Data Standards notice will specify the transition date The following SDTM IG 3.2 domains
Resources Web page at http:// for all version updates (with the month have not completed testing and
www.fda.gov/forindustry/ and day for the transition date acceptance and are not supported at this
datastandards/studydatastandards/ corresponding to March 15). time: Death Details and Exposure as
default.htm. The eStudy Data guidance The transition date for support (see Collected. The therapeutic area (TA)
implements the electronic submission section II. Exceptions) of the 3.2 version standards (http://www.cdisc.org/) that
requirements of section 745A(a) of the of CDISC STDM IG is March 15, 2017. are included in SDTM IG 3.2 have not
FD&C Act (21 U.S.C. 379k–1) for study Although SDTM IG version 3.2 is completed testing and acceptance and
data contained in new drug applications supported as of this Federal Register are not supported at this time. The
(NDAs), abbreviated new drug notice and sponsors or applicants are specific domain and the TA standard
applications (ANDAs), biologics license encouraged to begin using it, the new are listed in the table that follows:
applications (BLAs), and investigational version will only be required in
SDTM IG 3.2 Domain TA User guide
1. Healthcare Encounters ............... Cardiovascular Studies, 1.0; Polycystic Kidney Disease, 1.0; Asthma, 1.0.
2. Microscopic Findings .................. Tuberculosis, 1.0; Parkinson’s, 1.0.
3. Morphology ................................. Cardiovascular Studies, 1.0; Parkinson’s, 1.0; Polycystic Kidney Disease, 1.0; Alzheimer’s, 1.0; Multiple
Sclerosis, 1.0.
4. Procedures .................................. Cardiovascular Studies, 1.0; Polycystic Kidney Disease, 1.0; Alzheimer’s, 1.0.
5. Reproductive System .................. Polycystic Kidney Disease, 1.0.
6. Disease Response ...................... Tuberculosis, 1.0.
7. Skin Response ............................ Asthma, 1.0.
Sponsors and applicants with Dated: August 12, 2015. ADDRESSES: Submit your comments to
questions on how to implement the Leslie Kux, Information.CollectionClearance@
FDA-supported study data standards Associate Commissioner for Policy. hhs.gov or by calling (202) 690–6162.
should contact and work with FDA [FR Doc. 2015–20316 Filed 8–17–15; 8:45 am] FOR FURTHER INFORMATION CONTACT:
technical staff. For questions, contact BILLING CODE 4164–01–P Information Collection Clearance staff,
CDER at cder-edata@fda.hhs.gov or Information.CollectionClearance@
CBER at cber.cdisc@fda.hhs.gov. hhs.gov or (202) 690–6162.
DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: When
III. Comments HUMAN SERVICES submitting comments or requesting
Interested persons may submit either information, please include the
Office of the Secretary
electronic comments regarding this document identifier HHS–OS–0990–
document to http://www.regulations.gov [Document Identifier: HHS–OS–0990–New– New–60D.
60D]
or written comments to the Division of Information Collection Request Title:
Dockets Management (see ADDRESSES). It Agency Information Collection Evaluation of the Office on Women’s
is only necessary to send one set of Activities; Proposed Collection; Public Health Coalition for a Healthier
comments. Identify comments with the Comment Request Community Initiative
docket number found in brackets in the Abstract: This collection is to provide
heading of this document. Received AGENCY: Office of the Secretary, HHS.
ACTION: Notice. data for the national evaluation of the
comments may be seen in the Division U.S. Department of Health and Human
of Dockets Management between 9 a.m. SUMMARY: In compliance with section Services (HHS), Office on Women’s
and 4 p.m., Monday through Friday, and 3506(c)(2)(A) of the Paperwork Health (OWH) Coalition for a Healthier
will be posted to the docket at http:// Reduction Act of 1995, the Office of the Community (CHC) Initiative. The
www.regulations.gov. Secretary (OS), Department of Health initiative supports 10 communities with
and Human Services, announces plans grants to support coalitions in
IV. Electronic Access
to submit a new Information Collection implementing gender-based public
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Persons with access to the Internet Request (ICR), described below, to the health systems approaches, evidence-
may obtain the proposed Office of Management and Budget based health interventions, and
recommendations at either http:// (OMB). Prior to submitting the ICR to outreach and education activities to
www.fda.gov/forindustry/ OMB, OS seeks comments from the reduce barriers to and enhance
public regarding the burden estimate, facilitators of improvements in women
datastandards/studydatastandards/
below, or any other aspect of the ICR. and girls’ health. Each of the grantees
default.htm or http://
www.regulations.gov. DATES: Comments on the ICR must be has implemented an IRB-approved local
received on or before October 19, 2015. evaluation; however, OWH is seeking to
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Document Created: 2015-12-15 12:04:33
Document Modified: 2015-12-15 12:04:33
| 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. | |
| 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] | |
| FR Citation | 80 FR 50014 |
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