82 FR 45858 - Electronic Study Data Submission; Data Standards; Support for Analysis Data Model Implementation Guide Version 1.1
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 189 (October 2, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 189 (October 2, 2017)
| Page Range | 45858-45859 | |
| FR Document | 2017-21081 |
[Federal Register Volume 82, Number 189 (Monday, October 2, 2017)] [Notices] [Pages 45858-45859] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-21081] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-2837] Electronic Study Data Submission; Data Standards; Support for Analysis Data Model Implementation Guide Version 1.1 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) is announcing support for version 1.1 of Clinical Data Interchange Standards Consortium (CDISC), Analysis Data Model Implementation Guide (ADaM IG V1.1), an update to the FDA Data Standards Catalog (Catalog). (See http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm). ADaM IG V1.1 has been available from CDISC (www.cdisc.org) since February 12, 2016. FDA is encouraging sponsors and applicants to use ADaM IG V1.1 in investigational study data provided in regulatory submissions to CDER. 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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, 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-2017-N-2837 for ``Electronic Study Data Submission; Data Standards; Support for Analysis Data Model Implementation Guide Version 1.1.'' 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 Dockets Management Staff 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.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the [[Page 45859]] 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Ron Fitzmartin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1115, Silver Spring, MD 20993-0002, 301- 796-5333, email: [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 (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and investigational new drug applications (INDs) to the Center for Biologics Evaluation and Research (CBER) or CDER by specifying the format for electronic submissions. The implementation of electronic submission requirements for study data became effective on December 17, 2016 (24 months after issuance of final guidance for NDAs, BLAs, ANDAs, and 36 months for INDs). The eStudy Data guidance states that a Federal Register notice will specify the transition date for all version updates (with the month and day for the transition date corresponding to March 15). The transition date for support of version 1.1 of ADaM 1G V 1.1 is March 15, 2018. ADaM IG V.1.1 is supported as of this Federal Register notice and sponsors or applicants are encouraged to begin using it, the new version will only be required in submissions for studies that start after March 15, 2019. The Catalog will list March 15, 2019, which will be reflected in the Catalog, as the ``date requirement begins.'' When multiple versions of an FDA-supported standard are listed in the Catalog, sponsors or applicants can select any of those version to use. The transition date for the end of FDA support for ADaM IG V 1.0, is March 15, 2018. II. Electronic Access Persons with access to the Internet may obtain the referenced material at http://www.fda.gov/ectd. Dated: September 22, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-21081 Filed 9-29-17; 8:45 am] BILLING CODE 4164-01-P
![45858 Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Notices
III. Participating in the Public DEPARTMENT OF HEALTH AND Written/Paper Submissions
Workshop HUMAN SERVICES Submit written/paper submissions as
Registration: Persons interested in follows:
Food and Drug Administration • Mail/Hand delivery/Courier (for
attending this public workshop must
[Docket No. FDA–2017–N–2837] written/paper submissions): Dockets
register online at https://
Management Staff (HFA–305), Food and
survey.co1.qualtrics.com/jfe/form/SV_ Electronic Study Data Submission; Drug Administration, 5630 Fishers
6X23XS8WXHtfWAJ. Please provide Data Standards; Support for Analysis Lane, Rm. 1061, Rockville, MD 20852.
complete contact information for each Data Model Implementation Guide • For written/paper comments
attendee, including name, title, Version 1.1 submitted to the Dockets Management
affiliation, address, email, and Staff, FDA will post your comment, as
AGENCY: Food and Drug Administration,
telephone. well as any attachments, except for
HHS.
Registration is free and based on ACTION: Notice. information submitted, marked and
space availability, with priority given to identified, as confidential, if submitted
early registrants. Persons interested in SUMMARY: The Food and Drug as detailed in ‘‘Instructions.’’
attending this public workshop must Administration (FDA) Center for Drug Instructions: All submissions received
register by October 2, 2017, midnight, Evaluation and Research (CDER) is must include the Docket No. FDA–
Eastern Time. Early registration is announcing support for version 1.1 of 2017–N–2837 for ‘‘Electronic Study
recommended because seating is Clinical Data Interchange Standards Data Submission; Data Standards;
limited; therefore, FDA may limit the Consortium (CDISC), Analysis Data Support for Analysis Data Model
Model Implementation Guide (ADaM IG Implementation Guide Version 1.1.’’
number of participants from each
V1.1), an update to the FDA Data Received comments will be placed in
organization.
Standards Catalog (Catalog). (See http:// the docket and, except for those
If you need special accommodations www.fda.gov/forindustry/ submitted as ‘‘Confidential
due to a disability, please contact datastandards/studydatastandards/ Submissions,’’ publicly viewable at
Xiaohui Jiang (see FOR FURTHER default.htm). ADaM IG V1.1 has been https://www.regulations.gov or at the
INFORMATION CONTACT) no later than available from CDISC (www.cdisc.org) Dockets Management Staff between 9
October 2, 2017. since February 12, 2016. FDA is a.m. and 4 p.m., Monday through
Streaming Webcast of the public encouraging sponsors and applicants to Friday.
workshop: This public workshop will use ADaM IG V1.1 in investigational • Confidential Submissions—To
also be webcast. A live webcast of this study data provided in regulatory submit a comment with confidential
submissions to CDER. information that you do not wish to be
workshop will be viewable at https://
DATES: Submit either electronic or made publicly available, submit your
collaboration.fda.gov/complex
written comments at any time. comments only as a written/paper
genericdrugs/ on the day of the
ADDRESSES: You may submit comments submission. You should submit two
workshop. copies total. One copy will include the
as follows:
If you have never attended a Connect information you claim to be confidential
Pro event before, test your connection at Electronic Submissions with a heading or cover note that states
https://collaboration.fda.gov/common/ Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
help/en/support/meeting_test.htm. To following way: CONFIDENTIAL INFORMATION.’’ The
get a quick overview of the Connect Pro • Federal eRulemaking Portal: Agency will review this copy, including
program, visit https://www.adobe.com/ https://www.regulations.gov. Follow the the claimed confidential information, in
go/connectpro_overview. FDA has instructions for submitting comments. its consideration of comments. The
verified the Web site addresses in this Comments submitted electronically, second copy, which will have the
document, as of the date this document including attachments, to https:// claimed confidential information
publishes in the Federal Register, but www.regulations.gov will be posted to redacted/blacked out, will be available
Web sites are subject to change over the docket unchanged. Because your for public viewing and posted on
time. comment will be made public, you are https://www.regulations.gov. Submit
solely responsible for ensuring that your both copies to the Division of Dockets
Transcripts: Please be advised that as comment does not include any Management. If you do not wish your
soon as a transcript of the public confidential information that you or a name and contact information to be
workshop is available, it will be third party may not wish to be posted, made publicly available, you can
accessible at https:// such as medical information, your or provide this information on the cover
www.regulations.gov. It may be viewed anyone else’s Social Security number, or sheet and not in the body of your
at the Dockets Management Staff (see confidential business information, such comments and you must identify this
ADDRESSES). A link to the transcript will as a manufacturing process. Please note information as ‘‘confidential.’’ Any
also be available on the Internet at that if you include your name, contact information marked as ‘‘confidential’’
https://www.fda.gov/drugs/newsevents/ information, or other information that will not be disclosed except in
ucm552461.htm. identifies you in the body of your accordance with 21 CFR 10.20 and other
Dated: September 26, 2017. comments, that information will be applicable disclosure law. For more
information about FDA’s posting of
sradovich on DSK3GMQ082PROD with NOTICES
posted on https://www.regulations.gov.
Anna K. Abram, • If you want to submit a comment comments to public dockets, see 80 FR
Deputy Commissioner for Policy, Planning, with confidential information that you 56469, September 18, 2015, or access
Legislation, and Analysis. do not wish to be made available to the the information at: https://www.gpo.gov/
[FR Doc. 2017–21018 Filed 9–29–17; 8:45 am] public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
BILLING CODE 4164–01–P written/paper submission and in the 23389.pdf.
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
Submissions’’ and ‘‘Instructions’’). read background documents or the
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![Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Notices 45859
electronic and written/paper comments The transition date for the end of FDA SUPPLEMENTARY INFORMATION:
received, go to https:// support for ADaM IG V 1.0, is March 15,
www.regulations.gov and insert the 2018. I. Background
docket number, found in brackets in the Section 3086 of the Cures Act (Pub. L.
II. Electronic Access
heading of this document, into the 114–255) added section 565A to the
‘‘Search’’ box and follow the prompts Persons with access to the Internet
FD&C Act (21 U.S.C. 360bbb–4a). In
and/or go to the Dockets Management may obtain the referenced material at
section 565A of the FD&C Act, Congress
Staff, 5630 Fishers Lane, Rm. 1061, http://www.fda.gov/ectd.
encouraged development of material
Rockville, MD 20852. Dated: September 22, 2017. threat MCMs by offering additional
FOR FURTHER INFORMATION CONTACT: Ron Leslie Kux, incentives for obtaining FDA approval
Fitzmartin, Center for Drug Evaluation Associate Commissioner for Policy. of such products. Under section 565A of
and Research, Food and Drug [FR Doc. 2017–21081 Filed 9–29–17; 8:45 am] the FD&C Act, the sponsor of an eligible
Administration, 10903 New Hampshire BILLING CODE 4164–01–P material threat MCM application (as
Ave., Bldg. 51, Rm. 1115, Silver Spring, defined in section 565A(a)(4)) shall
MD 20993–0002, 301–796–5333, email: receive a priority review voucher upon
CDERDataStandards@fda.hhs.gov. DEPARTMENT OF HEALTH AND approval of the material threat MCM
HUMAN SERVICES application. The recipient of a material
SUPPLEMENTARY INFORMATION:
Food and Drug Administration threat MCM priority review voucher
I. Background may either use the voucher for a future
[Docket No. FDA–2017–N–0007] human drug application submitted to
On December 17, 2014, FDA
FDA under section 505(b)(1) of the
published final guidance for industry Fee for Using a Material Threat Medical
FD&C Act (21 U.S.C. 355(b)(1)) or
‘‘Providing Regulatory Submissions in Countermeasure Priority Review
Voucher in Fiscal Year 2018 section 351(a) of the Public Health
Electronic Format—Standardized Study
Data’’ (eStudy Data) posted on FDA’s Service Act (42 U.S.C. 262(a)), or
AGENCY: Food and Drug Administration, transfer (including by sale) the voucher
Study Data Standards Resources Web
HHS. to another party. The voucher may be
page at http://www.fda.gov/forindustry/
datastandards/studydatastandards/ ACTION: Notice. transferred (including by sale)
default.htm. The eStudy Data guidance repeatedly until it ultimately is used for
SUMMARY: The Food and Drug a human drug application submitted to
implements the electronic submission Administration (FDA or the Agency) is
requirements of section 745A(a) of the FDA under section 505(b)(1) of the
announcing the fee rate for using a FD&C Act or section 351(a) of the Public
Federal Food, Drug, and Cosmetic Act material threat medical countermeasure
(21 U.S.C. 379k–1(a)) for study data Health Service Act. A priority review is
(MCM) priority review voucher for fiscal a review conducted with a Prescription
contained in new drug applications year (FY) 2018. The Federal Food, Drug,
(NDAs), abbreviated new drug Drug User Fee Act (PDUFA) goal date of
and Cosmetic Act (the FD&C Act), as
applications (ANDAs), biologics license 6 months after the receipt or filing date,
amended by the 21st Century Cures Act
applications (BLAs), and investigational (Cures Act), authorizes FDA to depending on the type of application.
new drug applications (INDs) to the determine and collect material threat Information regarding PDUFA goals is
Center for Biologics Evaluation and MCM priority review user fees for available at https://www.fda.gov/
Research (CBER) or CDER by specifying certain applications for review of downloads/forindustry/userfees/
the format for electronic submissions. human drug products when those prescriptiondruguserfee/
The implementation of electronic applications use a material threat MCM ucm511438.pdf.
submission requirements for study data priority review voucher. These vouchers The applicant that uses a material
became effective on December 17, 2016 are awarded to the sponsors of material threat MCM priority review voucher is
(24 months after issuance of final threat MCM applications that meet all of entitled to a priority review of its
guidance for NDAs, BLAs, ANDAs, and the requirements of this program upon eligible human drug application, but
36 months for INDs). The eStudy Data FDA approval of such applications. The must pay FDA a material threat MCM
guidance states that a Federal Register amount of the fee for using a material priority review user fee in addition to
notice will specify the transition date threat MCM priority review voucher is
for all version updates (with the month any user fee required by PDUFA for the
determined each FY based on the application. Information regarding the
and day for the transition date difference between the average cost
corresponding to March 15). material threat MCM priority review
incurred by FDA in the review of a
voucher program is available at: https://
The transition date for support of human drug application subject to
www.fda.gov/EmergencyPreparedness/
version 1.1 of ADaM 1G V 1.1 is March priority review in the previous FY, and
Counterterrorism/Medical
15, 2018. ADaM IG V.1.1 is supported the average cost incurred in the review
of an application that is not subject to Countermeasures/MCMLegalRegulatory
as of this Federal Register notice and
priority review in the previous FY. This andPolicyFramework/
sponsors or applicants are encouraged
notice establishes the material threat ucm566498.htm#prv.
to begin using it, the new version will
only be required in submissions for MCM priority review fee rate for FY This notice establishes the material
studies that start after March 15, 2019. 2018 and outlines the payment threat MCM priority review fee rate for
sradovich on DSK3GMQ082PROD with NOTICES
The Catalog will list March 15, 2019, procedures for such fees. FY 2018 at $2,830,579 and outlines
which will be reflected in the Catalog, FOR FURTHER INFORMATION CONTACT: FDA’s procedures for payment of
as the ‘‘date requirement begins.’’ When Robert J. Marcarelli, Office of Financial material threat MCM priority review
multiple versions of an FDA-supported Management, Food and Drug user fees. This rate is effective on
standard are listed in the Catalog, Administration, 8455 Colesville Rd., October 1, 2017, and will remain in
sponsors or applicants can select any of COLE–14202F, Silver Spring, MD effect through September 30, 2018.
those version to use. 20993–0002, 301–796–7223.
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Document Created: 2017-09-30 04:41:36
Document Modified: 2017-09-30 04:41:36
| 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 | Ron Fitzmartin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1115, Silver Spring, MD 20993-0002, 301- 796-5333, email: [email protected] | |
| FR Citation | 82 FR 45858 |
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