Documents to Support Submission of an Electronic Common Technical Document; Availability, 46763-46764 [2012-19087]

Download as PDF Federal Register / Vol. 77, No. 151 / Monday, August 6, 2012 / Notices DC 20447, Attn: ACF Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: infocollection@acf.hhs.gov. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Fax: 202–395–7285, Email: OIRA_SUBMISSION@OMB.EOP.GOV Attn: Desk Officer for the Administration for Children and Families. Robert Sargis, Reports Clearance Officer. [FR Doc. 2012–19141 Filed 8–3–12; 8:45 am] BILLING CODE 4184–01–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 of the following final versions of 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 2.0’’ (which includes the U.S. regional document type definition (DTD), version 3.0) and ‘‘Comprehensive Table of Contents Headings and Hierarchy, version 2.0.’’ Supporting technical files are also being made available on the Agency Web site. These documents represent FDA’s major updates to Module 1 of the eCTD, which contains regional information. FDA is not prepared at present to accept submissions utilizing this new version because eCTD software vendors need time to update their software to accommodate this information and because its use will require software mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:11 Aug 03, 2012 Jkt 226001 upgrades within the Agency. FDA estimates it will be able to receive submissions utilizing Module 1 Specifications 2.0 by September 2013, but this is not a firm date and we 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 selfaddressed 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: Virginia Hussong, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm 1161, Silver Spring, MD 20993, email: Esub@fda.hhs.gov; or Mary Padgett, Center for Biologics Evaluation and Research (HFM–25), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852, 301– 827–0373, email: mary.padgett@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, to provide clarification of business rules for submission processing and review, to refine the characterization of promotional marketing and advertising material, and to facilitate automated processing of submissions. In preparation for the Module 1 update, FDA made available draft technical documentation for public comment in a Federal Register notice dated October 26, 2011 (Docket No. PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 46763 FDA–2011–N–0724). After considering comments submitted, FDA revised the draft documentation and is making available final versions of the following documents: • ‘‘The eCTD Backbone Files Specification for Module 1, version 2.0,’’ which provides specifications for creating the eCTD backbone file for Module 1 for submission to CDER and CBER. It should be used in conjunction with the guidance for industry ‘‘Providing Regulatory Submissions in Electronic Format—Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications,’’ which can be found online (https://www.fda.gov/ downloads/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/ UCM072349.pdf), and which will be revised as part of the implementation of the updated eCTD backbone files specification. • ‘‘Comprehensive Table of Contents Headings and Hierarchy, version 2.0,’’ which reflects updated headings that are specified in the draft document entitled ‘‘The eCTD Backbone Files Specification for Module 1, version 2.0,’’ as well as mappings to regulations and legislation. Supporting technical files are also being made available on the Agency Web site. The documents include changes that: • Allow submission of promotional label and advertising materials to CDER in eCTD format; • Provide for processing of grouped submissions (e.g., a supplement that can be applied to more than one new drug application or biologics license application); • Provide detailed contact information so that companies can specify points of contact to discuss technical matters that may arise with a submission; • Clarify headings; • Use attributes in place of certain headings to provide flexibility for future changes without revising the specification itself. FDA is not prepared at present to accept submissions utilizing this new version 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 2.0 by September 2013, but this is not a firm date and we will give 30 days advance notice to industry. E:\FR\FM\06AUN1.SGM 06AUN1 46764 Federal Register / Vol. 77, No. 151 / Monday, August 6, 2012 / 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/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm. Dated: July 31, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–19087 Filed 8–3–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0011] Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01) AGENCY: I. Funding Opportunity Description Food and Drug Administration, RFA–FD–13–001 93.103 HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of FDA’s Office of Orphan Products Development (OPD) grant program. The goal of FDA’s OPD grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the proposed product will be superior to the existing therapy. FDA provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products. Applicants must include in the application’s Background and Significance section documentation to support the assertion that the product to be studied meets the statutory criteria to qualify for the grant and an explanation of how the proposed study will either help support product approval or provide essential data needed for product development. DATES: Important dates are as follows: 1. The application due dates are February 6, 2013; February 5, 2014. The resubmission due dates are October 15, 2013; October 15, 2014. 2. The anticipated start dates are November 2013; November 2014. 3. The opening date is December 6, 2013. 4. The expiration date is February 6, 2014; October 16, 2014 (resubmission). SUMMARY: mstockstill on DSK4VPTVN1PROD with NOTICES For Further Information and Additional Requirements Contact: Katherine Needleman, Office of Orphan Products Development, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5271, Silver Spring, MD 20993–0002, Phone: 301–796–8660, Email: katherine.needleman@fda.hhs.gov; or Vieda Hubbard, Office of Acquisitions & Grant Services, 5630 Fishers Lane, rm. 2034, Rockville, MD 20857, Phone: 301– 827–7177, Email: vieda.hubbard@fda.hhs.gov. For more information on this funding opportunity announcement (FOA) and to obtain detailed requirements, please refer to the full FOA located at https:// grants.nih.gov/grants/guide (select the ‘‘Request for Applications’’ link), https:// www.grants.gov (see ‘‘For Applicants’’ section), and https://www.fda.gov/ ForIndustry/DevelopingProductsforRare DiseasesConditions/WhomtoContact aboutOrphanProductDevelopment/ucm 134580.htm. SUPPLEMENTARY INFORMATION: VerDate Mar<15>2010 17:11 Aug 03, 2012 Jkt 226001 A. Background The OPD was created to identify and promote the development of orphan products. Orphan products are drugs, biologics, medical devices, and medical foods that are indicated for a rare disease or condition. The term ‘‘rare disease or condition’’ is defined in section 528 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ee). FDA generally considers drugs, devices, and medical foods potentially eligible for grants under the OPD grant program if they are indicated for a disease or condition that has a prevalence, not incidence, of fewer than 200,000 people in the United States. Diagnostics and vaccines are considered potentially eligible for such grants only if the U.S. population to whom they will be administered is fewer than 200,000 people in the United States per year. B. Research Objectives The goal of FDA’s OPD grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the proposed product will be superior to the existing therapy. FDA provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products. Applicants must include in the application’s Background and PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 Significance section documentation to support the assertion that the product to be studied meets the statutory criteria to qualify for the grant and an explanation of how the proposed study will either help support product approval or provide essential data needed for product development. C. Eligibility Information The grants are available to any foreign or domestic, public or private, for-profit or nonprofit entity (including State and local units of government). Federal Agencies that are not part of the Department of Health and Human Services (HHS) may apply. Agencies that are part of HHS may not apply. Forprofit entities must commit to excluding fees or profit in their request for support to receive grant awards. Organizations that engage in lobbying activities, as described in section 501(c)(4) of the Internal Revenue Code of 1968, are not eligible to receive grant awards. II. Award Information/Funds Available A. Award Amount Of the estimated FY 2014 funding ($14.1 million), approximately $10 million will fund noncompeting continuation awards, and approximately $4.1 million will fund 5 to 10 new awards, subject to availability of funds. It is anticipated that funding for the number of noncompeting continuation awards and new awards in FY 2015 will be similar to FY 2014. Phase 1 studies are eligible for grants of up to $200,000 per year for up to 3 years. Phase 2 and 3 studies are eligible for grants of up to $400,000 per year for up to 4 years. Please note that the dollar limitation will apply to total costs (direct plus indirect). Budgets for each year of requested support may not exceed the $200,000 or $400,000 total cost limit, whichever is applicable. B. Length of Support The length of support will depend on the nature of the study. For those studies with an expected duration of more than 1 year, a second, third, or fourth year of noncompetitive continuation of support will depend on the following factors: (1) Performance during the preceding year; (2) compliance with regulatory requirements of IND/investigational device exemption (IDE); and (3) availability of Federal funds. III. Electronic Application, Registration, and Submission Only electronic applications will be accepted. To submit an electronic application in response to this FOA, applicants should first review the full E:\FR\FM\06AUN1.SGM 06AUN1

Agencies

[Federal Register Volume 77, Number 151 (Monday, August 6, 2012)]
[Notices]
[Pages 46763-46764]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-19087]


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

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 of the following final versions of 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 2.0'' (which includes the 
U.S. regional document type definition (DTD), version 3.0) and 
``Comprehensive Table of Contents Headings and Hierarchy, version 
2.0.'' Supporting technical files are also being made available on the 
Agency Web site. These documents represent FDA's major updates to 
Module 1 of the eCTD, which contains regional information. FDA is not 
prepared at present to accept submissions utilizing this new version 
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 2.0 by September 2013, 
but this is not a firm date and we 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: Virginia Hussong, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm 1161, Silver Spring, MD 20993, email: 
Esub@fda.hhs.gov; or Mary Padgett, Center for Biologics Evaluation and 
Research (HFM-25), Food and Drug Administration, 1401 Rockville Pike, 
suite 200N, Rockville, MD 20852, 301-827-0373, email: 
mary.padgett@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, to provide clarification of business 
rules for submission processing and review, to refine the 
characterization of promotional marketing and advertising material, and 
to facilitate automated processing of submissions. In preparation for 
the Module 1 update, FDA made available draft technical documentation 
for public comment in a Federal Register notice dated October 26, 2011 
(Docket No. FDA-2011-N-0724). After considering comments submitted, FDA 
revised the draft documentation and is making available final versions 
of the following documents:
     ``The eCTD Backbone Files Specification for Module 1, 
version 2.0,'' which provides specifications for creating the eCTD 
backbone file for Module 1 for submission to CDER and CBER. It should 
be used in conjunction with the guidance for industry ``Providing 
Regulatory Submissions in Electronic Format--Human Pharmaceutical 
Product Applications and Related Submissions Using the eCTD 
Specifications,'' which can be found online (https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072349.pdf), and which will be revised as part of the implementation 
of the updated eCTD backbone files specification.
     ``Comprehensive Table of Contents Headings and Hierarchy, 
version 2.0,'' which reflects updated headings that are specified in 
the draft document entitled ``The eCTD Backbone Files Specification for 
Module 1, version 2.0,'' as well as mappings to regulations and 
legislation.
    Supporting technical files are also being made available on the 
Agency Web site. The documents include changes that:
     Allow submission of promotional label and advertising 
materials to CDER in eCTD format;
     Provide for processing of grouped submissions (e.g., a 
supplement that can be applied to more than one new drug application or 
biologics license application);
     Provide detailed contact information so that companies can 
specify points of contact to discuss technical matters that may arise 
with a submission;
     Clarify headings;
     Use attributes in place of certain headings to provide 
flexibility for future changes without revising the specification 
itself.
    FDA is not prepared at present to accept submissions utilizing this 
new version 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 2.0 by 
September 2013, but this is not a firm date and we will give 30 days 
advance notice to industry.

[[Page 46764]]

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: July 31, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-19087 Filed 8-3-12; 8:45 am]
BILLING CODE 4160-01-P

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