81 FR 14450 - Electronic Study Data Submission; Data Standards; Support End Date for Case Report Tabulation Data Definition Specification Version 1.0
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 52 (March 17, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 52 (March 17, 2016)
| Page Range | 14450-14451 | |
| FR Document | 2016-05958 |
[Federal Register Volume 81, Number 52 (Thursday, March 17, 2016)] [Notices] [Pages 14450-14451] From the Federal Register Online [www.thefederalregister.org] [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: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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 http://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 http://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: http://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 http://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, [email protected]; 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, [email protected]. 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 http://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 http://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 http://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
![14450 Federal Register / Vol. 81, No. 52 / Thursday, March 17, 2016 / Notices
www.fda.gov/AdvisoryCommittees/ speakers for the scheduled open public Tabulation Data Definition Specification
default.htm and scroll down to the hearing session. The contact person will (Define.xml) and an update to the FDA
appropriate advisory committee meeting notify interested persons regarding their Data Standards Catalog. Use of
link, or call the advisory committee request to speak by May 16, 2016. Define.xml Version 2.0, which has been
information line to learn about possible Closed Committee Deliberations: On available since March 2013, is the newer
modifications before coming to the June 7, 2016, from 8 a.m. to 9:30 a.m., standard supported by FDA. FDA
meeting. the meeting will be closed to permit support for Define.xml Version 1.0 will
Agenda: The committees will be discussion and review of trade secret end for studies that start 12 months after
asked to discuss new drug application and/or confidential commercial March 15, 2017.
(NDA) 207975, hydrocodone bitartrate information (5 U.S.C. 552b(c)(4)). DATES: Submit either electronic or
extended-release tablets, submitted by During this session, the committees will written comments at any time.
Teva Branded Pharmaceutical Products discuss the drug development program
ADDRESSES: You may submit comments
R&D, Inc., with the proposed indication of an investigational abuse-deterrent
of management of pain severe enough to as follows:
opioid product.
require daily, around-the-clock, long- Persons attending FDA’s advisory Electronic Submissions
term opioid treatment and for which committee meetings are advised that the
Submit electronic comments in the
alternative treatment options are Agency is not responsible for providing
following way:
inadequate. The product is an extended- access to electrical outlets.
release formulation intended to have • Federal eRulemaking Portal: http://
FDA welcomes the attendance of the
abuse-deterrent properties based on its www.regulations.gov. Follow the
public at its advisory committee
physicochemical properties. The instructions for submitting comments.
meetings and will make every effort to
committees will be asked to discuss Comments submitted electronically,
accommodate persons with disabilities.
whether the data submitted by the including attachments, to http://
If you require accommodations due to a
Applicant are sufficient to support www.regulations.gov will be posted to
disability, please contact Stephanie L.
labeling of the product with the the docket unchanged. Because your
Begansky at least 7 days in advance of
properties expected to deter abuse. comment will be made public, you are
the meeting.
FDA intends to make background FDA is committed to the orderly solely responsible for ensuring that your
material available to the public no later conduct of its advisory committee comment does not include any
than 2 business days before the meeting. meetings. Please visit our Web site at confidential information that you or a
If FDA is unable to post the background http://www.fda.gov/ third party may not wish to be posted,
material on its Web site prior to the AdvisoryCommittees/ such as medical information, your or
meeting, the background material will AboutAdvisoryCommittees/ anyone else’s Social Security number, or
be made publicly available at the ucm111462.htm for procedures on confidential business information, such
location of the advisory committee public conduct during advisory as a manufacturing process. Please note
meeting, and the background material committee meetings. that if you include your name, contact
will be posted on FDA’s Web site after Notice of this meeting is given under information, or other information that
the meeting. Background material is the Federal Advisory Committee Act (5 identifies you in the body of your
available at http://www.fda.gov/ U.S.C. app. 2). comments, that information will be
AdvisoryCommittees/Calendar/ posted on http://www.regulations.gov.
Dated: March 14, 2016.
default.htm. Scroll down to the • If you want to submit a comment
Jill Hartzler Warner, with confidential information that you
appropriate advisory committee meeting
Associate Commissioner for Special Medical do not wish to be made available to the
link.
Programs. public, submit the comment as a
Procedure: On June 7, 2016, from 9:30
a.m. to 4 p.m., the meeting is open to [FR Doc. 2016–06017 Filed 3–16–16; 8:45 am] written/paper submission and in the
the public. Interested persons may BILLING CODE 4164–01–P manner detailed (see ‘‘Written/Paper
present data, information, or views, Submissions’’ and ‘‘Instructions’’).
orally or in writing, on issues pending
DEPARTMENT OF HEALTH AND Written/Paper Submissions
before the committees. Written
submissions may be made to the contact HUMAN SERVICES Submit written/paper submissions as
person on or before May 23, 2016. Oral follows:
Food and Drug Administration
presentations from the public will be • Mail/Hand delivery/Courier (for
scheduled between approximately 1 [Docket No. FDA–2014–N–1840] written/paper submissions): Division of
p.m. and 2 p.m. Those individuals Dockets Management (HFA–305), Food
interested in making formal oral Electronic Study Data Submission; and Drug Administration, 5630 Fishers
presentations should notify the contact Data Standards; Support End Date for Lane, Rm. 1061, Rockville, MD 20852.
person and submit a brief statement of Case Report Tabulation Data Definition • For written/paper comments
the general nature of the evidence or Specification Version 1.0 submitted to the Division of Dockets
arguments they wish to present, the AGENCY: Food and Drug Administration, Management, FDA will post your
names and addresses of proposed HHS. comment, as well as any attachments,
participants, and an indication of the ACTION: Notice. except for information submitted,
approximate time requested to make marked and identified, as confidential,
asabaliauskas on DSK3SPTVN1PROD with NOTICES
their presentation on or before May 13, SUMMARY: The Food and Drug if submitted as detailed in
2016. Time allotted for each Administration’s (FDA or Agency) ‘‘Instructions.’’
presentation may be limited. If the Center for Biologics Evaluation and Instructions: All submissions received
number of registrants requesting to Research (CBER) and Center for Drug must include the Docket No. FDA–
speak is greater than can be reasonably Evaluation and Research (CDER) are 2014–N–1840 for ‘‘Electronic Study
accommodated during the scheduled announcing the end of support for Data Submission; Data Standards;
open public hearing session, FDA may Version 1.0 of Clinical Data Interchange Support End Date for Case Report
conduct a lottery to determine the Standards Consortium Case Report Tabulation Data Definition Specification
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![Federal Register / Vol. 81, No. 52 / Thursday, March 17, 2016 / Notices 14451
Version 1.0.’’ Received comments will MD 20993–0002, 240–402–8187, ACTION: Notice.
be placed in the docket and, except for jack.zhang@fda.hhs.gov.
those submitted as ‘‘Confidential This notice announces a forthcoming
SUPPLEMENTARY INFORMATION:
Submissions,’’ publicly viewable at meeting of a public advisory committee
http://www.regulations.gov or at the I. Background of the Food and Drug Administration
Division of Dockets Management (FDA). At least one portion of the
On December 17, 2014, FDA
between 9 a.m. and 4 p.m., Monday meeting will be closed to the public.
published final guidance for industry
Name of Committees: Anesthetic and
through Friday. ‘‘Providing Regulatory Submissions in
Analgesic Drug Products Advisory
• Confidential Submissions—To Electronic Format—Standardized Study
Committee and the Drug Safety and Risk
submit a comment with confidential Data’’ (eStudy Data) posted on FDA’s
Management Advisory Committee.
information that you do not wish to be Study Data Standards Resources Web General Function of the Committees:
made publicly available, submit your page at http://www.fda.gov/forindustry/ To provide advice and
comments only as a written/paper datastandards/studydatastandards/ recommendations to the Agency on
submission. You should submit two default.htm. The eStudy Data guidance FDA’s regulatory issues.
copies total. One copy will include the implements the electronic submission Date and Time: The meeting will be
information you claim to be confidential requirements of section 745A(a) of the held on June 8, 2016, from 8 a.m. to 4
with a heading or cover note that states Federal Food, Drug, and Cosmetic Act p.m.
‘‘THIS DOCUMENT CONTAINS (21 U.S.C. 379k–1(a)) for study data Location: FDA White Oak Campus,
CONFIDENTIAL INFORMATION.’’ The contained in new drug applications, 10903 New Hampshire Ave., Bldg. 31
Agency will review this copy, including abbreviated new drug applications, Conference Center, the Great Room (Rm.
the claimed confidential information, in biologics license applications, and 1503), Silver Spring, MD 20993–0002.
its consideration of comments. The investigational new drug applications Answers to commonly asked questions
second copy, which will have the submitted to CDER or CBER by including information regarding special
claimed confidential information specifying the format for electronic accommodations due to a disability,
redacted/blacked out, will be available submissions. The eStudy Data guidance visitor parking, and transportation may
for public viewing and posted on states that a Federal Register notice will be accessed at: http://www.fda.gov/
http://www.regulations.gov. Submit specify the transition date for updates to AdvisoryCommittees/
both copies to the Division of Dockets standards (with the month and day for AboutAdvisoryCommittees/
Management. If you do not wish your the transition date corresponding to ucm408555.htm.
name and contact information to be March 15). Contact Person: Stephanie L.
made publicly available, you can The transition date for the end of FDA Begansky, Center for Drug Evaluation
provide this information on the cover support for Define.xml Version 1.0 is and Research, Food and Drug
sheet and not in the body of your March 15, 2017. Therefore, FDA support Administration, 10903 New Hampshire
comments and you must identify this for Define.xml Version 1.0 will end for Ave., Bldg. 31, Rm. 2417, Silver Spring,
information as ‘‘confidential.’’ Any studies that start after March 15, 2018. MD 20993–0002, 301–796–9001, FAX:
information marked as ‘‘confidential’’ The FDA Data Standards Catalog (see 301–847–8533, email: AADPAC@
will not be disclosed except in http://www.fda.gov/forindustry/ fda.hhs.gov, or FDA Advisory
accordance with 21 CFR 10.20 and other datastandards/studydatastandards/ Committee Information Line, 1–800–
applicable disclosure law. For more default.htm) will be updated to list 741–8138 (301–443–0572 in the
information about FDA’s posting of March 15, 2018, as the ‘‘date support Washington, DC area). A notice in the
comments to public dockets, see 80 FR ends.’’ Federal Register about last minute
56469, September 18, 2015, or access II. Electronic Access modifications that impact a previously
the information at: http://www.fda.gov/ announced advisory committee meeting
regulatoryinformation/dockets/ Persons with access to the Internet cannot always be published quickly
default.htm. may obtain the referenced material at enough to provide timely notice.
http://www.fda.gov/forindustry/ Therefore, you should always check the
Docket: For access to the docket to datastandards/studydatastandards/
read background documents or the Agency’s Web site at http://
default.htm. www.fda.gov/AdvisoryCommittees/
electronic and written/paper comments
received, go to http:// Dated: March 10, 2016. default.htm and scroll down to the
www.regulations.gov and insert the Leslie Kux, appropriate advisory committee meeting
docket number, found in brackets in the Associate Commissioner for Policy. link, or call the advisory committee
heading of this document, into the [FR Doc. 2016–05958 Filed 3–16–16; 8:45 am] information line to learn about possible
‘‘Search’’ box and follow the prompts BILLING CODE 4164–01–P
modifications before coming to the
and/or go to the Division of Dockets meeting.
Agenda: The committees will be
Management, 5630 Fishers Lane, Rm.
DEPARTMENT OF HEALTH AND asked to discuss new drug application
1061, Rockville, MD 20852.
HUMAN SERVICES (NDA) 207621, oxycodone
FOR FURTHER INFORMATION CONTACT: hydrochloride and naltrexone
Fatima Frye, Center for Drug Evaluation Food and Drug Administration hydrochloride extended-release
and Research, Food and Drug capsules, submitted by Pfizer, Inc., with
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Administration, 10903 New Hampshire [Docket No. FDA–2016–N–0001] the proposed indication of management
Ave., Bldg. 51, Rm. 1192, Silver Spring, Anesthetic and Analgesic Drug of pain severe enough to require daily,
MD 20993–0002, 301–796–5333, Products Advisory Committee and the around-the-clock, long-term opioid
fatima.frye@fda.hhs.gov; or Jack Zhang, Drug Safety and Risk Management treatment and for which alternative
Center for Biologics Evaluation and Advisory Committee; Notice of Meeting treatment options are inadequate. The
Research, Food and Drug product is an extended-release
Administration, 10903 New Hampshire AGENCY: Food and Drug Administration, formulation intended to have abuse-
Ave., Bldg. 71, Rm. 7318, Silver Spring, HHS. deterrent properties based on the
VerDate Sep<11>2014 17:03 Mar 16, 2016 Jkt 238001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.SGM 17MRN1](https://thefederalregister.org/doc/81_FR_14502/page/2.svg)
Document Created: 2016-03-17 00:58:38
Document Modified: 2016-03-17 00:58:38
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments at any time. | |
| 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, [email protected]; 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, [email protected] | |
| FR Citation | 81 FR 14450 |
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