Study Data Technical Conformance Guide and Data Standards Catalog; Availability, 7204-7205 [2014-02554]

Download as PDF 7204 Federal Register / Vol. 79, No. 25 / Thursday, February 6, 2014 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–D–0503] Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards on Investigational New Drug Applications—Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. II. Request for Comments Notice; reopening of the comment period. ACTION: The Food and Drug Administration (FDA or we) is reopening the comment period for the final guidance for clinical investigators, sponsors, and institutional review boards (IRBs) entitled ‘‘Investigational New Drug Applications (INDs)— Determining whether Human Research Studies can be Conducted without an IND,’’ published in the Federal Register of September 10, 2013 (78 FR 55262). We are reopening the comment period only with respect to those subsections of the final guidance that address the applicability of the IND regulations to clinical research studies involving cosmetics and foods (including dietary supplements). DATES: Submit either electronic or written comments by April 7, 2014. ADDRESSES: Submit electronic comments on the final 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. FOR FURTHER INFORMATION CONTACT: Paul L. Ferrari, Center for Food Safety and Applied Nutrition (HFS–024), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740–3835, 240–402–1722. SUPPLEMENTARY INFORMATION: SUMMARY: mstockstill on DSK4VPTVN1PROD with NOTICES I. Background In the Federal Register of October 14, 2010 (75 FR 63189), we published a notice announcing the availability of a draft guidance entitled ‘‘Guidance for Industry: Investigational New Drug Applications (INDs)—Determining whether Human Research Studies can be Conducted without an IND’’ (‘‘the draft guidance’’). In the Federal Register of September 10, 2013 (78 FR 55262), we published a notice announcing the availability of the final version of the VerDate Mar<15>2010 18:18 Feb 05, 2014 Jkt 232001 guidance, entitled ‘‘Guidance for Clinical Investigators, Sponsors, and IRBs: Investigational New Drug Applications (INDs)—Determining whether Human Research Studies can be Conducted without an IND’’ (‘‘the final guidance’’). We are reopening the comment period only with respect to those subsections of the final guidance that address the applicability of the IND regulations to clinical research studies involving cosmetics and foods (including dietary supplements), in response to requests from interested persons. Following publication of the September 10, 2013, Federal Register notice of availability of the final guidance, we received correspondence asking us to provide for further opportunity to comment on subsections C (‘‘Cosmetics’’) and D (‘‘Foods’’) of section VI (‘‘Specific Issues Concerning the Application of the IND Regulations’’) of the final guidance. The correspondence explained that more time was needed to review the guidance and consider its effect on researchers and health care providers, among others. In response to these requests, we have decided to reopen the comment period with respect to the foods and cosmetics subsections of the final guidance for 60 days. Accordingly, we invite comment on subsections VI.C and VI.D by April 7, 2014. III. How To Submit Comments Interested persons may submit either electronic comments regarding subsections VI.C and VI.D of the final guidance 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. Dated: January 31, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–02550 Filed 2–5–14; 8:45 am] BILLING CODE 4160–01–P PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–0092] Study Data Technical Conformance Guide and Data Standards Catalog; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a Study Data Technical Conformance Guide and an update to the Data Standards Catalog (formerly the Study Data Standards Catalog). The Study Data Technical Conformance Guide supplements the revised draft 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 specified in the Data Standards Catalog. DATES: Although you can comment on these documents at any time, to ensure that the Agency considers your comments, please submit either electronic or written comments by May 7, 2014. ADDRESSES: Submit written requests for a copy of the Study Data Technical Conformance Guide and the Data Standards Catalog to the Division of Drug Information, Center for Drug Evaluation and Research (CDER), 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), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852–1448. Send one selfaddressed adhesive label to assist that office in processing your requests. Submit electronic comments on the Study Data Technical Conformance Guide and the Data Standards Catalog 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. FOR FURTHER INFORMATION CONTACT: Ron Fitzmartin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1160, Silver Spring, MD 20993–0002, CDERDataStandards@ SUMMARY: E:\FR\FM\06FEN1.SGM 06FEN1 Federal Register / Vol. 79, No. 25 / Thursday, February 6, 2014 / Notices fda.hhs.gov; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852–1448, 301–827–6210. SUPPLEMENTARY INFORMATION: mstockstill on DSK4VPTVN1PROD with NOTICES I. Background FDA is announcing the availability of a Study Data Technical Conformance Guide (the Guide) and an update to the Study Data Standards Catalog, which will be revised and renamed the Data Standards Catalog (the Catalog). The Guide supplements the guidance for industry, ‘‘Providing Regulatory Submissions in Electronic Format— Standardized Study Data,’’ (eStudy Data guidance) (available at https://www.fda. gov/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/ default.htm), and provides technical recommendations to sponsors for the electronic submission of standardized animal and human study data and related information contained in certain submissions to new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologic license applications (BLAs), and investigational new drug applications (INDs). The eStudy Data guidance, when finalized, will implement the electronic submission requirements of section 745A(a) of the Federal Food, Drug, and Cosmetic Act with respect to standardized study data contained in NDA, ANDA, BLA, and IND submissions. The Guide integrates and updates the Study Data Specifications and the CDER Common Data Standards Issues document and is available on FDA’s Study Data Standards Resources Web page at https://www.fda.gov/forindustry/ datastandards/studydatastandards/ default.htm. The Guide is intended to complement and promote interactions between sponsors and FDA review divisions. It is not intended to replace the need for sponsors to communicate directly with review divisions regarding data standards implementation approaches or issues. The Guide, when finalized, will supersede the Study Data Specifications (Versions 1.0–2.0) and the CDER Study Data Common Issues Document (Versions 1.0–1.1). The Guide is organized as follows: Section 1: Introduction—provides information on regulatory policy and guidance background, purpose, and document control. Section 2: Planning and Providing Standardized Study Data—recommends and provides details on preparing an overall study data standardization plan and a study data reviewer’s guide. VerDate Mar<15>2010 18:18 Feb 05, 2014 Jkt 232001 Section 3: Exchange Format— Electronic Submissions—presents the specifications, considerations, and recommendations for the file formats currently supported by FDA. Section 4: Study Data Submission Format: Clinical and Non-Clinical— presents general considerations and specifications for sponsors using, for example, the following standards for the submission of study data: Clinical Data Interchange Standards Consortium, Study Data Tabulation Model, Analysis Data Model, and Standard for Exchange of Nonclinical Data. Section 5: Therapeutic Area Standards—presents supplemental considerations and specific recommendations when sponsors submit study data using FDA supported TA standards. Section 6: Terminology—presents general considerations and specific recommendations when using controlled terminologies/vocabularies for clinical trial data. Section 7: General Electronic Submission Format—provides specifications and recommendations on submitting study data using the electronic Common Technical Document format. Section 8: Data Fitness—provides general recommendations on standards compliance, data traceability expectations, legacy data conversion, versioning, and data validation rules. 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 Guide and the Catalog at either https://www.fda.gov/forindustry/ datastandards/studydatastandards/ default.htm or https://www.regulations. gov. Dated: January 31, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–02554 Filed 2–5–14; 8:45 am] BILLING CODE 4160–01–P PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 7205 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0001] Advancing the Development of Pediatric Therapeutics: Pediatric Bone Health; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration’s (FDA) Pediatric and Maternal Health Staff in the Center for Drug Evaluation and Research and the Office of Pediatric Therapeutics are announcing a 1-day public workshop entitled ‘‘Advancing the Development of Pediatric Therapeutics (ADEPT): Pediatric Bone Health.’’ The purpose of this initial workshop is to provide a forum to consider issues related to advancing pediatric regulatory science in the evaluation of bone health in pediatric patients. Date and Time: The public workshop will be held on March 4, 2014, from 8:30 a.m. to 5 p.m. Location: The public workshop will be held in the Pooks Hill Marriott, 5151 Pooks Hill Rd., Bethesda, MD 20814. The hotel’s telephone number is 301– 897–9400. Contact: Denise Pica-Branco, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–1732, Fax: 301– 796–9858, email: denise.picabranco@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: FDA has engaged experts in pediatrics to address challenging issues related to the evaluation of effects on bone health for products used to treat pediatric patients. Identification of signals in animal studies and adult clinical trials that warrant further clinical investigation and identification of biomarkers that may be predictive of bone health in children will be discussed. Additionally, strategies and methods to address the challenges of assessing longterm bone health for products used to treat pediatric patients will be discussed. SUMMARY: I. Participation in the Public Workshop There is no fee to attend the public workshop, but attendees should register in advance. Space is limited, and registration will be on a first-come, firstserved basis. Persons interested in attending this workshop must register online at PediatricBoneHealth@ fda.hhs.gov before February 28, 2014. E:\FR\FM\06FEN1.SGM 06FEN1

Agencies

[Federal Register Volume 79, Number 25 (Thursday, February 6, 2014)]
[Notices]
[Pages 7204-7205]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02554]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0092]


Study Data Technical Conformance Guide and Data Standards 
Catalog; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a Study Data Technical Conformance Guide and an update 
to the Data Standards Catalog (formerly the Study Data Standards 
Catalog). The Study Data Technical Conformance Guide supplements the 
revised draft 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 
specified in the Data Standards Catalog.

DATES: Although you can comment on these documents at any time, to 
ensure that the Agency considers your comments, please submit either 
electronic or written comments by May 7, 2014.

ADDRESSES: Submit written requests for a copy of the Study Data 
Technical Conformance Guide and the Data Standards Catalog to the 
Division of Drug Information, Center for Drug Evaluation and Research 
(CDER), 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), Center for Biologics Evaluation and 
Research, Food and Drug Administration, 1401 Rockville Pike, Suite 
200N, Rockville, MD 20852-1448. Send one self-addressed adhesive label 
to assist that office in processing your requests.
    Submit electronic comments on the Study Data Technical Conformance 
Guide and the Data Standards Catalog 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.

FOR FURTHER INFORMATION CONTACT: Ron Fitzmartin, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1160, Silver Spring, MD 20993-0002, 
CDERDataStandards@

[[Page 7205]]

fda.hhs.gov; or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 1401 Rockville Pike, Suite 
200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a Study Data Technical 
Conformance Guide (the Guide) and an update to the Study Data Standards 
Catalog, which will be revised and renamed the Data Standards Catalog 
(the Catalog). The Guide supplements the guidance for industry, 
``Providing Regulatory Submissions in Electronic Format--Standardized 
Study Data,'' (eStudy Data guidance) (available at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm), 
and provides technical recommendations to sponsors for the electronic 
submission of standardized animal and human study data and related 
information contained in certain submissions to new drug applications 
(NDAs), abbreviated new drug applications (ANDAs), biologic license 
applications (BLAs), and investigational new drug applications (INDs). 
The eStudy Data guidance, when finalized, will implement the electronic 
submission requirements of section 745A(a) of the Federal Food, Drug, 
and Cosmetic Act with respect to standardized study data contained in 
NDA, ANDA, BLA, and IND submissions.
    The Guide integrates and updates the Study Data Specifications and 
the CDER Common Data Standards Issues document and is available on 
FDA's Study Data Standards Resources Web page at https://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm. The Guide is 
intended to complement and promote interactions between sponsors and 
FDA review divisions. It is not intended to replace the need for 
sponsors to communicate directly with review divisions regarding data 
standards implementation approaches or issues. The Guide, when 
finalized, will supersede the Study Data Specifications (Versions 1.0-
2.0) and the CDER Study Data Common Issues Document (Versions 1.0-1.1). 
The Guide is organized as follows:
    Section 1: Introduction--provides information on regulatory policy 
and guidance background, purpose, and document control.
    Section 2: Planning and Providing Standardized Study Data--
recommends and provides details on preparing an overall study data 
standardization plan and a study data reviewer's guide.
    Section 3: Exchange Format--Electronic Submissions--presents the 
specifications, considerations, and recommendations for the file 
formats currently supported by FDA.
    Section 4: Study Data Submission Format: Clinical and Non-
Clinical--presents general considerations and specifications for 
sponsors using, for example, the following standards for the submission 
of study data: Clinical Data Interchange Standards Consortium, Study 
Data Tabulation Model, Analysis Data Model, and Standard for Exchange 
of Nonclinical Data.
    Section 5: Therapeutic Area Standards--presents supplemental 
considerations and specific recommendations when sponsors submit study 
data using FDA supported TA standards.
    Section 6: Terminology--presents general considerations and 
specific recommendations when using controlled terminologies/
vocabularies for clinical trial data.
    Section 7: General Electronic Submission Format--provides 
specifications and recommendations on submitting study data using the 
electronic Common Technical Document format.
    Section 8: Data Fitness--provides general recommendations on 
standards compliance, data traceability expectations, legacy data 
conversion, versioning, and data validation rules.

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 Guide and the 
Catalog at either https://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm or https://www.regulations.gov.

    Dated: January 31, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-02554 Filed 2-5-14; 8:45 am]
BILLING CODE 4160-01-P
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