Documents To Support Submission of an Electronic Common Technical Document; Availability, 10181-10182 [2013-03319]

Download as PDF Federal Register / Vol. 78, No. 30 / Wednesday, February 13, 2013 / Notices • User experience and evaluation of current processes and tools and their effects on organizational performance; • Needs and specifications for proposed new tools and processes; • Business processes driving the development of information systems; and • The effect of processes and tools on problem solving quality, efficiency, and cost. All abstracts must be received by February 15, 2013, and authors whose posters have been accepted will be notified by February 28, 2013. The conference will make available an exhibition hall. The exhibitor price for this conference is $3,500. Neither PhUSE nor FDA endorse any commercial software or vendor. Dated: February 7, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–03324 Filed 2–12–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Global Quality Systems—An Integrated Approach To Improving Medical Product Safety; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration (FDA) Cincinnati District Office, in cosponsorship with the Association of Food and Drug Officials (AFDO), is announcing a public workshop entitled ‘‘Global Quality Systems—An Integrated Approach to Improving Medical Product Safety.’’ This 2-day public workshop is intended to provide information about FDA drug and device regulation to the regulated industry. DATES: The public workshop will be held on June 10 and 11, 2013, from 8 a.m. to 5 p.m. ADDRESSES: The public workshop will be held at the Louisville Marriott Downtown, 280 West Jefferson St., Louisville, KY, 502–627–5045 or tollfree 800–533–0127; http:// www.marriottlouisville.com/. Attendees are responsible for their own accommodations. To make reservations at the Louisville Marriott Downtown, at the reduced conference rate, contact the Louisville Marriott mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:21 Feb 12, 2013 Jkt 229001 10181 and/or devices. Topics for discussion include the following: • Future of Combination Product Regulation. • Unique Device Identifier Progress. • Health Canada Update. • The Safety of our Drugs and Devices—the Complex Reality. • Nanotechnology. • Drug and Medical Device Trends. • Case for Quality (Center for Devices and Radiological Health) Presented by Steve Silverman. • Working Luncheon Interactive Session—Lessons Learned From the Mistakes of Others. • Complaint Handling—It’s Not Just About Compliance—It’s an Effective Business Driver. • FDA’s Cosmetic Regulatory Agenda. • Challenges With Implementation of U.S.P. 35 on a Global Basis. • Pilot Program for Abbreviated Drug Inspections. FDA has made education of the drug and device manufacturing community a high priority to help ensure the quality COST OF REGISTRATION of FDA-regulated drugs and devices. Member ......................................... $450.00 The workshop helps to achieve Non-Member ................................. $550.00 objectives set forth in section 406 of the To be added to registration fee for Food and Drug Administration registration postmarked after Modernization Act of 1997 (Pub. L. 105– May 14, 2013 ............................ $100.00 115) (21 U.S.C. 393), which includes working closely with stakeholders and If you need special accommodations maximizing the availability and clarity due to a disability, please contact of information to stakeholders and the Krystal Reed (see FOR FURTHER public. The workshop also is consistent INFORMATION CONTACT) at least 21 days in with the Small Business Regulatory advance of the workshop. Enforcement Fairness Act of 1996 (Pub. Registration instructions: To register, L. 104–121), as outreach activities by please complete and submit an AFDO Government Agencies to small Conference Registration Form, along businesses. with a check or money order payable to Dated: February 8, 2013. ‘‘AFDO.’’ Please mail your completed registration form and payment to: Leslie Kux, AFDO, 2550 Kingston Rd., suite 311, Assistant Commissioner for Policy. York, PA 17402. To register online, [FR Doc. 2013–03323 Filed 2–12–13; 8:45 am] please visit http://www.afdo.org/ BILLING CODE 4160–01–P conference. (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after DEPARTMENT OF HEALTH AND this document publishes in the Federal HUMAN SERVICES Register.) The registrar will also accept payment Food and Drug Administration through Visa and MasterCard credit [Docket No. FDA–2011–N–0724] cards. For more information on the public workshop, or for questions about Documents To Support Submission of registration, please contact AFDO at an Electronic Common Technical 717–757–2888, FAX: 717–650–3650, or Document; Availability email: afdo@afdo.org The public workshop helps fulfill the AGENCY: Food and Drug Administration, Department of Health and Human HHS. Services’ and FDA’s important mission ACTION: Notice. to protect the public health. The workshop will provide FDA-regulated SUMMARY: The Food and Drug drug and device entities with Administration (FDA) is announcing the information on a number of topics availability of the following revised concerning FDA requirements related to final versions of documents that support the production and marketing of drugs making regulatory submissions in Downtown before May 2, 2013, and cite meeting code ‘‘AFDO Conference.’’ FOR FURTHER INFORMATION CONTACT: Krystal Reed, Association of Food and Drug Officials, 2550 Kingston Rd., suite 311, York, PA 17402, 717–757–2888, FAX: 717–650–3650, email: kreed@afdo.org. SUPPLEMENTARY INFORMATION: Registration: You are encouraged to register by May 14, 2013. The AFDO registration fees cover the cost of facilities, materials, and breaks. Seats are limited; therefore, please submit your registration as soon as possible. Course space will be filled in order of receipt of registration. Those accepted into the course will receive confirmation. Registration will close after the course is filled. Registration at the site is not guaranteed but may be possible on a space available basis on the day of the public workshop beginning at 7:30 a.m. The cost of registration is as follows: PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\FR\FM\13FEN1.SGM 13FEN1 10182 Federal Register / Vol. 78, No. 30 / Wednesday, February 13, 2013 / Notices mstockstill on DSK4VPTVN1PROD with NOTICES electronic format using the electronic Common Technical Document (eCTD) specifications: ‘‘The eCTD Backbone Files Specification for Module 1, version 2.1’’ (which includes the U.S. regional document type definition, version 3.1), and ‘‘Comprehensive Table of Contents Headings and Hierarchy, version 2.1.’’ 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 2.1 by September 2013 and will give 30 days advanced 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: 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, 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, 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; 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 VerDate Mar<15>2010 17:21 Feb 12, 2013 Jkt 229001 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 announced availability of final versions of technical documentation in the Federal Register of August 6, 2012 (77 FR 46763). FDA has revised the final documentation and is making available revised versions of the following documents: • ‘‘The eCTD Backbone Files Specification for Module 1, version 2.1,’’ 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 entitled ‘‘Providing Regulatory Submissions in Electronic Format—Human Pharmaceutical Applications and Related Submissions,’’ which will be revised as part of the implementation of the updated eCTD backbone files specification. • ‘‘Comprehensive Table of Contents Headings and Hierarchy, version 2.1,’’ which reflects updated headings that are specified in the document entitled ‘‘The eCTD Backbone Files Specification for Module 1, version 2.1.’’ Supporting technical files are also 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: • The 1.16 heading regarding risk management was modified and subheadings were added. • The application-type attribute file was modified to include PMA and 510(k). • Attribute files were modified to allow the version, date, and number to be machine readable. 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 2.1 by September 2013 and will give 30 days advanced notice to industry. II. Electronic Access Persons with access to the Internet may obtain the documents at either http://www.fda.gov/Drugs/ DevelopmentApprovalProcess/ FormsSubmissionRequirements/ PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 ElectronicSubmissions/ucm253101.htm, http://www.regulations.gov, or http:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm. Dated: February 8, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–03319 Filed 2–12–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Ryan White HIV/AIDS Program, Part C Early Intervention Services Grant Under the Ryan White HIV/AIDS Program Health Resources and Services Administration (HRSA), Department of Health and Human Services. AGENCY: Notice of Ryan White HIV/AIDS Program (Part C) Early Intervention Services One-Time Noncompetitive Award to Ensure Continued HIV Primary Medical Care. ACTION: To prevent a lapse in comprehensive primary care services for persons living with HIV/AIDS, HRSA will provide one-time noncompetitive Part C funds to the Hoboken Community Healthcare, Inc., Hoboken, New Jersey. SUMMARY: The amount of the award to ensure ongoing HIV medical services is $327,166. SUPPLEMENTARY INFORMATION: Authority: Section 2651 of the Public Health Service Act, 42 U.S.C. § 300ff–51. CFDA Number: 93.918. Project period: The period of support for this award is from January 1, 2013, through June 30, 2013. Justification for the Exception to Competition: Hoboken Municipal Hospital Authority (HMHA), Hoboken, NJ; H76HA07886 announced the December 31, 2012, relinquishment of their Part C grant to Hoboken Community Healthcare, Inc., a nonprofit 501(c)(3) organization that purchased the hospital and associated clinics. Hoboken Community Healthcare, Inc. has been identified as an interim provider of the Part C grant. The amount of $327,166 will be awarded to Hoboken Community Healthcare, Inc., which represents a proportional share of the last award to HMHA. This funding will support HIV medical care until the start of a new funding cycle under HRSA– 13–168 with a July 1, 2013, start date. E:\FR\FM\13FEN1.SGM 13FEN1

Agencies

[Federal Register Volume 78, Number 30 (Wednesday, February 13, 2013)]
[Notices]
[Pages 10181-10182]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03319]


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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 of the following revised final versions of documents that 
support making regulatory submissions in

[[Page 10182]]

electronic format using the electronic Common Technical Document (eCTD) 
specifications: ``The eCTD Backbone Files Specification for Module 1, 
version 2.1'' (which includes the U.S. regional document type 
definition, version 3.1), and ``Comprehensive Table of Contents 
Headings and Hierarchy, version 2.1.'' 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 2.1 by September 2013 and will give 30 days advanced 
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, 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, 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; 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 announced availability of 
final versions of technical documentation in the Federal Register of 
August 6, 2012 (77 FR 46763). FDA has revised the final documentation 
and is making available revised versions of the following documents:
     ``The eCTD Backbone Files Specification for Module 1, 
version 2.1,'' 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 entitled 
``Providing Regulatory Submissions in Electronic Format--Human 
Pharmaceutical Applications and Related Submissions,'' which will be 
revised as part of the implementation of the updated eCTD backbone 
files specification.
     ``Comprehensive Table of Contents Headings and Hierarchy, 
version 2.1,'' which reflects updated headings that are specified in 
the document entitled ``The eCTD Backbone Files Specification for 
Module 1, version 2.1.''

Supporting technical files are also 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:
     The 1.16 heading regarding risk management was modified 
and subheadings were added.
     The application-type attribute file was modified to 
include PMA and 510(k).
     Attribute files were modified to allow the version, date, 
and number to be machine readable.
    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 2.1 by 
September 2013 and will give 30 days advanced notice to industry.

II. Electronic Access

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

    Dated: February 8, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03319 Filed 2-12-13; 8:45 am]
BILLING CODE 4160-01-P