Development of Prioritized Therapeutic Area Data Standards; Request for Comments, 69637-69638 [2012-28197]

Download as PDF Federal Register / Vol. 77, No. 224 / Tuesday, November 20, 2012 / Notices wreier-aviles on DSK5TPTVN1PROD with available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before January 14, 2013. Oral presentations from the public will be scheduled between approximately 12:30 p.m. to 1:30 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before January 4, 2013. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by January 7, 2013. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Cindy Hong at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/ AdvisoryCommittees/AboutAdvisory Committees/ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: November 15, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–28201 Filed 11–19–12; 8:45 am] BILLING CODE 4160–01–P VerDate Mar<15>2010 15:12 Nov 19, 2012 Jkt 229001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0974] Development of Prioritized Therapeutic Area Data Standards; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. The Food and Drug Administration (FDA) is announcing the intent to prioritize and develop therapeutic area data standards to facilitate the conduct of clinical research and the regulatory review of medical products. Therapeutic area disease and domain specific data standards should enable and enhance the ability to integrate, analyze, report, and share regulatory information. FDA has developed a roadmap that provides its current thinking on therapeutic area priorities and has posted it on the FDA Web site. FDA is actively participating with regulated industry, the Clinical Data Interchange Standards Consortium (CDISC), the Critical Path Institute, Health Level 7’s (HL7) Clinical Interoperability Council, and other stakeholders to support the development of these therapeutic area standards. The therapeutic area standards will be developed collaboratively based on open, consensus-based data standards development methodology. DATES: To ensure that the Agency considers your comments, submit either electronic or written comments by January 22, 2013. ADDRESSES: Submit written requests for a copy of the roadmap 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 the Office of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852– 1448. Send one self-addressed adhesive label to assist that office in processing your requests. Submit electronic comments on FDA’s objective to develop prioritized therapeutic area data standards or on the roadmap to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. SUMMARY: PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 69637 1061, Rockville, MD 20852. See the section for electronic access to the roadmap. 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@fda.hhs.gov; or Amy Malla, Center for Biologics Evaluation and Research (HFM–25), 1401 Rockville Pike, Suite 200N, Rockville, MD 20852–1448, 301–827– 6085. SUPPLEMENTARY INFORMATION: SUPPLEMENTARY INFORMATION I. Background Traditionally, clinical study data submitted to FDA is in a format that is unique to each individual sponsor; furthermore the data quality varies. This has created inefficiencies in the review process and impeded efforts to analyze the data across applications when such analyses could be beneficial to detect trends in safety or efficacy or for other reasons. Sponsor adoption of available clinical trial data standards (CDISC/ SDTM) for the submission of product applications have helped to improve the quality and standardization of submitted data. However, such a voluntary approach has proved insufficient to support both the current business requirements as well as efforts to modernize the review environment. In 2011, the Center for Drug Evaluation and Research (CDER) identified a set of disease and therapeutic areas that could benefit from further standardization. These content area standards are primarily intended to support the efficient evaluation of medical products as noted previously in this document. Several factors were considered in the identification of these areas: (1) Areas of particular need, (2) areas with existing data standardization projects underway, and (3) areas with greater drug development pipeline activity. The initial prioritization was based on the number of active investigational new drug applications (or INDs) and input from review divisions, as well as from industry. The three tiers of priority were assembled into a roadmap and posted on the FDA Web site at https://www.fda.gov/Drugs/ DevelopmentApprovalProcess/ FormsSubmissionRequirements/ ElectronicSubmissions/ucm287408.htm. The roadmap sets out a sequence of standardization efforts to achieve significant results by December 2017. CDER established a small grants program to fund projects that develop E:\FR\FM\20NON1.SGM 20NON1 69638 Federal Register / Vol. 77, No. 224 / Tuesday, November 20, 2012 / Notices disease and domain-specific therapeutic area data standards. On July 9, 2012, President Obama signed into law the Food and Drug Administration Safety and Innovation Act of 2012, which includes the reauthorization of the Prescription Drug User Fee Act (PDUFA V). Under section XII of the PDUFA V performance goals, FDA agreed to create a plan for distinct therapeutic area data standards and to prioritize and develop the data standards in collaboration with CDISC and other open standards organizations. FDA is seeking public comment on the roadmap and will consider the comments as the Agency develops its proposed project plan which is due to be issued for review and comment by June 30, 2013. In addition, FDA will publish notices soliciting input on, and engagement in, standards development activities, and will periodically issue guidances specifying the completed data standards, formats, and terminologies that sponsors should use to submit data in applications. II. Comments Interested persons may submit either written comments regarding the roadmap, as well as recommendations on how the therapeutic area data standards development effort could be accomplished more rapidly, 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. III. Electronic Access wreier-aviles on DSK5TPTVN1PROD with Persons with access to the Internet may obtain the roadmap at https:// www.fda.gov/Drugs/Development ApprovalProcess/FormsSubmission Requirements/ElectronicSubmissions/ ucm287408.htm, https://www.fda.gov/ BiologicsBloodVaccines/ GuidanceCompliance RegulatoryInformation/default.htm, or https://www.regulations.gov. Dated: November 15, 2012. Leslie Kux, Assistant Commissioner for Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institutes of Health National Institute of General Medical Sciences; Notice of Closed Meeting Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of General Medical Sciences Special Emphasis Panel, Review of Minority Biomedical Research Support Behavioral Applications. Date: November 28, 2012. Time: 1:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Natcher Building, 45 Center Drive, Room 3An.18, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Rebecca H. Johnson, Ph.D., Scientific Review Officer, Office of Scientific Review, National Institute of General Medical Sciences, National Institutes of Health, 45 Center Drive, Room 3An18C, Bethesda, MD 20892, 301–594–2771, johnsonrh@nigms.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.375, Minority Biomedical Research Support; 93.821, Cell Biology and Biophysics Research; 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.862, Genetics and Developmental Biology Research; 93.88, Minority Access to Research Careers; 93.96, Special Minority Initiatives, National Institutes of Health, HHS) Dated: November 14, 2012. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2012–28157 Filed 11–19–12; 8:45 am] BILLING CODE 4140–01–P [FR Doc. 2012–28197 Filed 11–19–12; 8:45 am] 15:12 Nov 19, 2012 Jkt 229001 Name of Committee: National Institute of Child Health and Human Development Special Emphasis Panel; ‘‘NIH Summer Research Experience Programs (R25)’’. Date: December 7, 2012. Time: 1:30 p.m. to 3:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6100 Executive Boulevard, Rockville, MD 20852, (Telephone Conference). Contact Person: Anne Krey, Ph.D., Scientific Review Officer, Division of Scientific Review, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, 6100 Executive Blvd., Room 5B01, Bethesda, MD 20892, 301–435–6908, ak41o@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS) Dated: November 13, 2012. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2012–28160 Filed 11–19–12; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as BILLING CODE 4160–01–P VerDate Mar<15>2010 Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\20NON1.SGM 20NON1

Agencies

[Federal Register Volume 77, Number 224 (Tuesday, November 20, 2012)]
[Notices]
[Pages 69637-69638]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-28197]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0974]


Development of Prioritized Therapeutic Area Data Standards; 
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
intent to prioritize and develop therapeutic area data standards to 
facilitate the conduct of clinical research and the regulatory review 
of medical products. Therapeutic area disease and domain specific data 
standards should enable and enhance the ability to integrate, analyze, 
report, and share regulatory information. FDA has developed a roadmap 
that provides its current thinking on therapeutic area priorities and 
has posted it on the FDA Web site. FDA is actively participating with 
regulated industry, the Clinical Data Interchange Standards Consortium 
(CDISC), the Critical Path Institute, Health Level 7's (HL7) Clinical 
Interoperability Council, and other stakeholders to support the 
development of these therapeutic area standards. The therapeutic area 
standards will be developed collaboratively based on open, consensus-
based data standards development methodology.

DATES: To ensure that the Agency considers your comments, submit either 
electronic or written comments by January 22, 2013.

ADDRESSES: Submit written requests for a copy of the roadmap 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 the Office of Communication, 
Outreach and Development (HFM-40), Center for Biologics Evaluation and 
Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, 
MD 20852-1448. Send one self-addressed adhesive label to assist that 
office in processing your requests.
    Submit electronic comments on FDA's objective to develop 
prioritized therapeutic area data standards or on the roadmap 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. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the roadmap.

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@fda.hhs.gov; or
Amy Malla, Center for Biologics Evaluation and Research (HFM-25), 1401 
Rockville Pike, Suite 200N, Rockville, MD 20852-1448, 301-827-6085.

SUPPLEMENTARY INFORMATION: 

I. Background

    Traditionally, clinical study data submitted to FDA is in a format 
that is unique to each individual sponsor; furthermore the data quality 
varies. This has created inefficiencies in the review process and 
impeded efforts to analyze the data across applications when such 
analyses could be beneficial to detect trends in safety or efficacy or 
for other reasons. Sponsor adoption of available clinical trial data 
standards (CDISC/SDTM) for the submission of product applications have 
helped to improve the quality and standardization of submitted data. 
However, such a voluntary approach has proved insufficient to support 
both the current business requirements as well as efforts to modernize 
the review environment.
    In 2011, the Center for Drug Evaluation and Research (CDER) 
identified a set of disease and therapeutic areas that could benefit 
from further standardization. These content area standards are 
primarily intended to support the efficient evaluation of medical 
products as noted previously in this document. Several factors were 
considered in the identification of these areas: (1) Areas of 
particular need, (2) areas with existing data standardization projects 
underway, and (3) areas with greater drug development pipeline 
activity. The initial prioritization was based on the number of active 
investigational new drug applications (or INDs) and input from review 
divisions, as well as from industry. The three tiers of priority were 
assembled into a roadmap and posted on the FDA Web site at https://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm287408.htm. The 
roadmap sets out a sequence of standardization efforts to achieve 
significant results by December 2017. CDER established a small grants 
program to fund projects that develop

[[Page 69638]]

disease and domain-specific therapeutic area data standards.
    On July 9, 2012, President Obama signed into law the Food and Drug 
Administration Safety and Innovation Act of 2012, which includes the 
reauthorization of the Prescription Drug User Fee Act (PDUFA V). Under 
section XII of the PDUFA V performance goals, FDA agreed to create a 
plan for distinct therapeutic area data standards and to prioritize and 
develop the data standards in collaboration with CDISC and other open 
standards organizations. FDA is seeking public comment on the roadmap 
and will consider the comments as the Agency develops its proposed 
project plan which is due to be issued for review and comment by June 
30, 2013. In addition, FDA will publish notices soliciting input on, 
and engagement in, standards development activities, and will 
periodically issue guidances specifying the completed data standards, 
formats, and terminologies that sponsors should use to submit data in 
applications.

II. Comments

    Interested persons may submit either written comments regarding the 
roadmap, as well as recommendations on how the therapeutic area data 
standards development effort could be accomplished more rapidly, 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.

III. Electronic Access

    Persons with access to the Internet may obtain the roadmap at 
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm287408.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov.

    Dated: November 15, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-28197 Filed 11-19-12; 8:45 am]
BILLING CODE 4160-01-P
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