Electronic Study Data Submission; Data Standards; Support End Date for Case Report Tabulation Data Definition Specification Version 1.0, 14450-14451 [2016-05958]

Download as PDF asabaliauskas on DSK3SPTVN1PROD with NOTICES 14450 Federal Register / Vol. 81, No. 52 / Thursday, March 17, 2016 / Notices www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: The committees will be asked to discuss new drug application (NDA) 207975, hydrocodone bitartrate extended-release tablets, submitted by Teva Branded Pharmaceutical Products R&D, Inc., with the proposed indication of management of pain severe enough to require daily, around-the-clock, longterm opioid treatment and for which alternative treatment options are inadequate. The product is an extendedrelease formulation intended to have abuse-deterrent properties based on its physicochemical properties. The committees will be asked to discuss whether the data submitted by the Applicant are sufficient to support labeling of the product with the properties expected to deter abuse. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: On June 7, 2016, from 9:30 a.m. to 4 p.m., the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committees. Written submissions may be made to the contact person on or before May 23, 2016. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 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 May 13, 2016. 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 VerDate Sep<11>2014 17:03 Mar 16, 2016 Jkt 238001 speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by May 16, 2016. Closed Committee Deliberations: On June 7, 2016, from 8 a.m. to 9:30 a.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential commercial information (5 U.S.C. 552b(c)(4)). During this session, the committees will discuss the drug development program of an investigational abuse-deterrent opioid product. 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 disabilities. If you require accommodations due to a disability, please contact Stephanie L. Begansky 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/ AboutAdvisoryCommittees/ 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: March 14, 2016. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2016–06017 Filed 3–16–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–1840] Electronic Study Data Submission; Data Standards; Support End Date for Case Report Tabulation Data Definition Specification Version 1.0 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration’s (FDA or Agency) Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) are announcing the end of support for Version 1.0 of Clinical Data Interchange Standards Consortium Case Report SUMMARY: PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 Tabulation Data Definition Specification (Define.xml) and an update to the FDA Data Standards Catalog. Use of Define.xml Version 2.0, which has been available since March 2013, is the newer standard supported by FDA. FDA support for Define.xml Version 1.0 will end for studies that start 12 months after March 15, 2017. DATES: Submit either electronic or written comments at any time. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2014–N–1840 for ‘‘Electronic Study Data Submission; Data Standards; Support End Date for Case Report Tabulation Data Definition Specification E:\FR\FM\17MRN1.SGM 17MRN1 Federal Register / Vol. 81, No. 52 / Thursday, March 17, 2016 / Notices Version 1.0.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.fda.gov/ regulatoryinformation/dockets/ default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. asabaliauskas on DSK3SPTVN1PROD with NOTICES FOR FURTHER INFORMATION CONTACT: Fatima Frye, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1192, Silver Spring, MD 20993–0002, 301–796–5333, fatima.frye@fda.hhs.gov; or Jack Zhang, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7318, Silver Spring, VerDate Sep<11>2014 17:03 Mar 16, 2016 Jkt 238001 MD 20993–0002, 240–402–8187, jack.zhang@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background On December 17, 2014, FDA published final guidance for industry ‘‘Providing Regulatory Submissions in Electronic Format—Standardized Study Data’’ (eStudy Data) posted on FDA’s Study Data Standards Resources Web page at https://www.fda.gov/forindustry/ datastandards/studydatastandards/ default.htm. The eStudy Data guidance implements the electronic submission requirements of section 745A(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379k–1(a)) for study data contained in new drug applications, abbreviated new drug applications, biologics license applications, and investigational new drug applications submitted to CDER or CBER by specifying the format for electronic submissions. The eStudy Data guidance states that a Federal Register notice will specify the transition date for updates to standards (with the month and day for the transition date corresponding to March 15). The transition date for the end of FDA support for Define.xml Version 1.0 is March 15, 2017. Therefore, FDA support for Define.xml Version 1.0 will end for studies that start after March 15, 2018. The FDA Data Standards Catalog (see https://www.fda.gov/forindustry/ datastandards/studydatastandards/ default.htm) will be updated to list March 15, 2018, as the ‘‘date support ends.’’ II. Electronic Access Persons with access to the Internet may obtain the referenced material at https://www.fda.gov/forindustry/ datastandards/studydatastandards/ default.htm. Dated: March 10, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–05958 Filed 3–16–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–0001] Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 ACTION: 14451 Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public. Name of Committees: Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. General Function of the Committees: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on June 8, 2016, from 8 a.m. to 4 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993–0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm408555.htm. Contact Person: Stephanie L. Begansky, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 301–796–9001, FAX: 301–847–8533, email: AADPAC@ fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site at https:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: The committees will be asked to discuss new drug application (NDA) 207621, oxycodone hydrochloride and naltrexone hydrochloride extended-release capsules, submitted by Pfizer, Inc., with the proposed indication of management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The product is an extended-release formulation intended to have abusedeterrent properties based on the E:\FR\FM\17MRN1.SGM 17MRN1

Agencies

[Federal Register Volume 81, Number 52 (Thursday, March 17, 2016)]
[Notices]
[Pages 14450-14451]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05958]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1840]

Electronic Study Data Submission; Data Standards; Support End
Date for Case Report Tabulation Data Definition Specification Version
1.0

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for
Biologics Evaluation and Research (CBER) and Center for Drug Evaluation
and Research (CDER) are announcing the end of support for Version 1.0
of Clinical Data Interchange Standards Consortium Case Report
Tabulation Data Definition Specification (Define.xml) and an update to
the FDA Data Standards Catalog. Use of Define.xml Version 2.0, which
has been available since March 2013, is the newer standard supported by
FDA. FDA support for Define.xml Version 1.0 will end for studies that
start 12 months after March 15, 2017.

DATES: Submit either electronic or written comments at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2014-N-1840 for ``Electronic Study Data Submission; Data Standards;
Support End Date for Case Report Tabulation Data Definition
Specification

[[Page 14451]]

Version 1.0.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Fatima Frye, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1192, Silver Spring, MD 20993-0002, 301-
796-5333, fatima.frye@fda.hhs.gov; or Jack Zhang, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7318, Silver Spring, MD 20993-0002, 240-
402-8187, jack.zhang@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

On December 17, 2014, FDA published final guidance for industry
``Providing Regulatory Submissions in Electronic Format--Standardized
Study Data'' (eStudy Data) posted on FDA's Study Data Standards
Resources Web page at https://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm. The eStudy Data guidance implements the
electronic submission requirements of section 745A(a) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379k-1(a)) for study data
contained in new drug applications, abbreviated new drug applications,
biologics license applications, and investigational new drug
applications submitted to CDER or CBER by specifying the format for
electronic submissions. The eStudy Data guidance states that a Federal
Register notice will specify the transition date for updates to
standards (with the month and day for the transition date corresponding
to March 15).
The transition date for the end of FDA support for Define.xml
Version 1.0 is March 15, 2017. Therefore, FDA support for Define.xml
Version 1.0 will end for studies that start after March 15, 2018. The
FDA Data Standards Catalog (see https://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm) will be updated to list
March 15, 2018, as the ``date support ends.''

II. Electronic Access

Persons with access to the Internet may obtain the referenced
material at https://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm.

Dated: March 10, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05958 Filed 3-16-16; 8:45 am]
BILLING CODE 4164-01-P

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