Documents to Support Submission of an Electronic Common Technical Document; Availability, 52776-52777 [2013-20697]

Download as PDF 52776 Federal Register / Vol. 78, No. 165 / Monday, August 26, 2013 / Notices sufficient for the purposes of reporting in the PETNet and LivestockNET portals of the Animal Feed Network. Therefore, FDA believes that the proposed collection of information does not have additional recordkeeping requirements. Dated: August 20, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–20710 Filed 8–23–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0724] Documents to Support Submission of an Electronic Common Technical Document; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability on the Agency Web site of revised final versions of the following four documents that support making regulatory submissions in electronic format using the electronic Common Technical Document (eCTD) specifications: ‘‘The eCTD Backbone Files Specification for Module 1,’’ version 2.2 (which includes the U.S. regional document type definition (DTD), version 3.2); ‘‘The Comprehensive Table of Contents Headings and Hierarchy,’’ version 2.2; ‘‘Specifications for eCTD Validation Criteria,’’ version 3.0; and ‘‘Example Submissions using eCTD Backbone Files Specification for Module 1,’’ version 1.2. Technical files that support these documents are also available on the Agency Web site. A complete summary of the revisions made is included in the updated documents. FDA estimates it will be able to receive submissions utilizing Module 1 Specifications 2.2 by June 2014, and will give 30 days’ advance notice to industry. ADDRESSES: Submit written requests for single copies of the documents 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 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- ehiers on DSK2VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 13:45 Aug 23, 2013 Jkt 229001 addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the documents. FOR FURTHER INFORMATION CONTACT: Constance Robinson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 1105, Silver Spring, MD 20993, 301–796– 1065, email: constance.robinson@ fda.hhs.gov; or Joseph Montgomery, Center for Biologics Evaluation and Research, Food and Drug Administration, 11400 Rockville Pike, HFM–165, Rm. 4155, Rockville, MD 20857, 301–827–1332, email: joseph.montgomery@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background The eCTD is an International Conference on Harmonisation (ICH) standard based on specifications developed by ICH and its member parties. FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have been receiving submissions in the eCTD format since 2003, and the eCTD has been the standard for electronic submissions to CDER and CBER since January 1, 2008. The majority of new electronic submissions are now received in eCTD format. Since adoption of the eCTD standard, it has become necessary to update the administrative portion of the eCTD (Module 1) to reflect regulatory changes, provide clarification of business rules for submission processing and review, refine the characterization of promotional marketing and advertising material, and facilitate automated processing of submissions. FDA previously announced availability of final versions of technical documentation in a Federal Register notice dated February 13, 2013 (Docket No. FDA–2011–N–0724). The Agency has revised the final documentation and is making available revised versions of the following documents: • ‘‘The eCTD Backbone Files Specification for Module 1, version 2.2,’’ which provides specifications for creating the eCTD backbone file for Module 1 for submission to CDER and CBER (This document should be used in conjunction with the guidance for industry Providing Regulatory Submissions in Electronic Format–– Human Pharmaceutical Applications and Related Submissions Using the eCTD Specifications, which will be revised as part of the implementation of the updated eCTD backbone files PO 00000 Frm 00019 Fmt 4703 Sfmt 4703 specification (https://www.fda.gov/ downloads/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/ UCM072349.pdf )). • ‘‘The Comprehensive Table of Contents Headings and Hierarchy,’’ version 2.2, which reflects updated headings that are specified in the document entitled ‘‘The eCTD Backbone Files Specification for Module 1,’’ version 2.2 • ‘‘Specifications for eCTD Validation Criteria,’’ version 3.0 • ‘‘Example Submissions using eCTD Backbone Files Specification for Module 1,’’ version 1.2 Supporting technical files are being made available on the Agency Web site. A complete summary of the revisions made are included in the updated documents. The revisions include the following: eCTD Backbone Files Specification for Module I Æ changed DTD version references from 3.1 to 3.2, where applicable Æ replaced the copy of DTD Version 3.1 in Appendix I with DTD Version 3 Æ revised text, revised Table 1, and added Table 13 to indicate the new required attribute material-id and the new optional attribute issuedate which applies to m1–15–2–1 The Comprehensive Table of Contents Headings and Hierarchy Æ added two new attributes for 1.15.2.1 Specifications for eCTD Validation Criteria Æ incorporated changes to US eCTD Module 1 Example Submissions using eCTD Backbone Files Specification for Module 1 Æ modified example 7 to reference the Form FDA 356h in the Admin section Æ modified examples 13 through 17 to reference the material-id and issue date attributes as applicable, and include the Promotional Labeling and Advertising Regulatory Contact FDA is not prepared at present to accept submissions utilizing this new version of the eCTD Backbone Files Specification for Module 1, version 2.2, because eCTD software vendors need time to update their software to accommodate this information and because its use will require software upgrades within the Agency. FDA estimates it will be able to receive submissions utilizing Module 1 Specifications 2.2 by June 2014, and will give 30 days advance notice to industry. E:\FR\FM\26AUN1.SGM 26AUN1 Federal Register / Vol. 78, No. 165 / Monday, August 26, 2013 / Notices II. Electronic Access Persons with access to the Internet may obtain the documents at either https://www.fda.gov/Drugs/Development ApprovalProcess/FormsSubmission Requirements/ElectronicSubmissions/ ucm253101.htm, https:// www.regulations.gov, or https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm. Dated: August 20, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–20697 Filed 8–23–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–D–0369] (Formerly Docket No. 2007D–0168) Draft Guidance for Industry on Bioequivalence Recommendations for Risperidone Injection; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled ‘‘Draft Guidance on Risperidone.’’ The guidance provides specific recommendations on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for risperidone injection. SUMMARY: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on 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 October 25, 2013. DATES: Submit written requests for single copies of the draft 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 draft guidance document. Submit electronic comments on the draft guidance to https:// www.regulations.gov. Submit written ehiers on DSK2VPTVN1PROD with NOTICES ADDRESSES: VerDate Mar<15>2010 13:45 Aug 23, 2013 Jkt 229001 52777 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: Kris Andre, Center for Drug Evaluation and Research (HFD–600), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–276–9326. SUPPLEMENTARY INFORMATION: The draft guidance, when finalized, will represent the Agency’s current thinking on the design of BE studies to support ANDAs for risperidone injection. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. I. Background II. Comments In the Federal Register of May 31, 2007 (72 FR 30388), FDA announced the availability of a draft guidance for industry entitled ‘‘Bioequivalence Recommendations for Specific Products,’’ which explained the process that would be used to make productspecific bioequivalence (BE) recommendations available to the public on FDA’s Web site at https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm. As described in that guidance, FDA adopted this process as a means to develop and disseminate product-specific BE recommendations and to provide a meaningful opportunity for the public to consider and comment on those recommendations. FDA finalized that guidance and announced its availability in the Federal Register of June 11, 2010 (75 FR 33311). This notice announces the availability of revised draft BE recommendations for risperidone injection. New drug application 021346 for Risperdal Consta (risperidone) LongActing Injection was initially approved by FDA in October 2003. In February 2010, FDA issued a draft guidance for industry on BE recommendations for generic risperidone injection (Draft BE Recommendations for Risperidone Injection). FDA is now issuing a revised version of the Draft BE Recommendations for Risperidone Injection (Revised Draft BE Recommendations). In February 2011, Johnson & Johnson Pharmaceutical Research and Development, L.L.C. submitted a citizen petition requesting that FDA require that any ANDA referencing Risperdal Consta (risperidone) Long-Acting Injection meet certain requirements, including requirements related to demonstrating BE (Docket No. FDA– 2011–P–0086). FDA is reviewing the issues raised in the petition. FDA will consider any comments on the Revised Draft BE Recommendations in responding to the citizen petition. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). Interested persons may submit either written comments regarding this document to the Division of Dockets Management (see ADDRESSES) or electronic comments to https:// www.regulations.gov. 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. PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 III. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. Dated: August 21, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–20696 Filed 8–23–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Implementation of the Revised International Guiding Principles for Biomedical Research Involving Animals The National Institutes of Health (NIH) is providing guidance to Public Health Service (PHS) awardee institutions on implementation of the revised International Guiding Principles for Biomedical Research Involving Animals (‘‘Guiding Principles’’). The NIH is seeking input from the public on any concerns they may have regarding the revised Guiding Principles. DATES: Public concerns regarding the revised Guiding Principles must be submitted electronically at https:// grants.nih.gov/grants/rfi/rfi.cfm?ID=35 by September 30, 2013 in order to be considered. SUMMARY: E:\FR\FM\26AUN1.SGM 26AUN1

Agencies

[Federal Register Volume 78, Number 165 (Monday, August 26, 2013)]
[Notices]
[Pages 52776-52777]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-20697]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0724]


Documents to Support Submission of an Electronic Common Technical 
Document; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability on the Agency Web site of revised final versions of the 
following four documents that support making regulatory submissions in 
electronic format using the electronic Common Technical Document (eCTD) 
specifications: ``The eCTD Backbone Files Specification for Module 1,'' 
version 2.2 (which includes the U.S. regional document type definition 
(DTD), version 3.2); ``The Comprehensive Table of Contents Headings and 
Hierarchy,'' version 2.2; ``Specifications for eCTD Validation 
Criteria,'' version 3.0; and ``Example Submissions using eCTD Backbone 
Files Specification for Module 1,'' version 1.2. Technical files that 
support these documents are also available on the Agency Web site. A 
complete summary of the revisions made is included in the updated 
documents. FDA estimates it will be able to receive submissions 
utilizing Module 1 Specifications 2.2 by June 2014, and will give 30 
days' advance notice to industry.

ADDRESSES: Submit written requests for single copies of the documents 
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 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. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the 
documents.

FOR FURTHER INFORMATION CONTACT: Constance Robinson, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 1105, Silver Spring, MD 20993, 301-796-
1065, email: constance.robinson@fda.hhs.gov; or Joseph Montgomery, 
Center for Biologics Evaluation and Research, Food and Drug 
Administration, 11400 Rockville Pike, HFM-165, Rm. 4155, Rockville, MD 
20857, 301-827-1332, email: joseph.montgomery@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    The eCTD is an International Conference on Harmonisation (ICH) 
standard based on specifications developed by ICH and its member 
parties. FDA's Center for Drug Evaluation and Research (CDER) and 
Center for Biologics Evaluation and Research (CBER) have been receiving 
submissions in the eCTD format since 2003, and the eCTD has been the 
standard for electronic submissions to CDER and CBER since January 1, 
2008. The majority of new electronic submissions are now received in 
eCTD format. Since adoption of the eCTD standard, it has become 
necessary to update the administrative portion of the eCTD (Module 1) 
to reflect regulatory changes, provide clarification of business rules 
for submission processing and review, refine the characterization of 
promotional marketing and advertising material, and facilitate 
automated processing of submissions. FDA previously announced 
availability of final versions of technical documentation in a Federal 
Register notice dated February 13, 2013 (Docket No. FDA-2011-N-0724). 
The Agency has revised the final documentation and is making available 
revised versions of the following documents:
     ``The eCTD Backbone Files Specification for Module 1, 
version 2.2,'' which provides specifications for creating the eCTD 
backbone file for Module 1 for submission to CDER and CBER (This 
document should be used in conjunction with the guidance for industry 
Providing Regulatory Submissions in Electronic Format--Human 
Pharmaceutical Applications and Related Submissions Using the eCTD 
Specifications, which will be revised as part of the implementation of 
the updated eCTD backbone files specification (https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072349.pdf )).
     ``The Comprehensive Table of Contents Headings and 
Hierarchy,'' version 2.2, which reflects updated headings that are 
specified in the document entitled ``The eCTD Backbone Files 
Specification for Module 1,'' version 2.2
     ``Specifications for eCTD Validation Criteria,'' version 
3.0
     ``Example Submissions using eCTD Backbone Files 
Specification for Module 1,'' version 1.2
    Supporting technical files are being made available on the Agency 
Web site.
    A complete summary of the revisions made are included in the 
updated documents. The revisions include the following:

eCTD Backbone Files Specification for Module I
    [cir] changed DTD version references from 3.1 to 3.2, where 
applicable
    [cir] replaced the copy of DTD Version 3.1 in Appendix I with DTD 
Version 3
    [cir] revised text, revised Table 1, and added Table 13 to indicate 
the new required attribute material-id and the new optional attribute 
issue-date which applies to m1-15-2-1
The Comprehensive Table of Contents Headings and Hierarchy
    [cir] added two new attributes for 1.15.2.1
Specifications for eCTD Validation Criteria
    [cir] incorporated changes to US eCTD Module 1
Example Submissions using eCTD Backbone Files Specification for Module 
1
    [cir] modified example 7 to reference the Form FDA 356h in the 
Admin section
    [cir] modified examples 13 through 17 to reference the material-id 
and issue date attributes as applicable, and include the Promotional 
Labeling and Advertising Regulatory Contact
    FDA is not prepared at present to accept submissions utilizing this 
new version of the eCTD Backbone Files Specification for Module 1, 
version 2.2, because eCTD software vendors need time to update their 
software to accommodate this information and because its use will 
require software upgrades within the Agency. FDA estimates it will be 
able to receive submissions utilizing Module 1 Specifications 2.2 by 
June 2014, and will give 30 days advance notice to industry.

[[Page 52777]]

II. Electronic Access

    Persons with access to the Internet may obtain the documents at 
either https://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm253101.htm, https://www.regulations.gov, or https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    Dated: August 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-20697 Filed 8-23-13; 8:45 am]
BILLING CODE 4160-01-P

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