Electronic Study Data Submission; Data Standards; Support for Analysis Data Model Implementation Guide Version 1.1, 45858-45859 [2017-21081]

Download as PDF 45858 Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Registration: Persons interested in attending this public workshop must register online at https:// survey.co1.qualtrics.com/jfe/form/SV_ 6X23XS8WXHtfWAJ. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone. Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public workshop must register by October 2, 2017, midnight, Eastern Time. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. If you need special accommodations due to a disability, please contact Xiaohui Jiang (see FOR FURTHER INFORMATION CONTACT) no later than October 2, 2017. Streaming Webcast of the public workshop: This public workshop will also be webcast. A live webcast of this workshop will be viewable at https:// collaboration.fda.gov/complex genericdrugs/ on the day of the workshop. If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/ help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit https://www.adobe.com/ go/connectpro_overview. FDA has verified the Web site addresses in this document, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. Transcripts: Please be advised that as soon as a transcript of the public workshop is available, it will be accessible at https:// www.regulations.gov. It may be viewed at the Dockets Management Staff (see ADDRESSES). A link to the transcript will also be available on the Internet at https://www.fda.gov/drugs/newsevents/ ucm552461.htm. sradovich on DSK3GMQ082PROD with NOTICES III. Participating in the Public Workshop Food and Drug Administration Dated: September 26, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–21018 Filed 9–29–17; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 19:01 Sep 29, 2017 Jkt 244001 [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. 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 https:// 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: SUMMARY: 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’’). PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the E:\FR\FM\02OCN1.SGM 02OCN1 Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Notices 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. 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: CDERDataStandards@fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: sradovich on DSK3GMQ082PROD with NOTICES 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 (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. 19:01 Sep 29, 2017 II. Electronic Access Persons with access to the Internet may obtain the referenced material at https://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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration I. Background VerDate Sep<11>2014 The transition date for the end of FDA support for ADaM IG V 1.0, is March 15, 2018. Jkt 244001 [Docket No. FDA–2017–N–0007] Fee for Using a Material Threat Medical Countermeasure Priority Review Voucher in Fiscal Year 2018 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a material threat medical countermeasure (MCM) priority review voucher for fiscal year (FY) 2018. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the 21st Century Cures Act (Cures Act), authorizes FDA to determine and collect material threat MCM priority review user fees for certain applications for review of human drug products when those applications use a material threat MCM priority review voucher. These vouchers are awarded to the sponsors of material threat MCM applications that meet all of the requirements of this program upon FDA approval of such applications. The amount of the fee for using a material threat MCM priority review voucher is determined each FY based on the difference between the average cost incurred by FDA in the review of a human drug application subject to priority review in the previous FY, and the average cost incurred in the review of an application that is not subject to priority review in the previous FY. This notice establishes the material threat MCM priority review fee rate for FY 2018 and outlines the payment procedures for such fees. FOR FURTHER INFORMATION CONTACT: Robert J. Marcarelli, Office of Financial Management, Food and Drug Administration, 8455 Colesville Rd., COLE–14202F, Silver Spring, MD 20993–0002, 301–796–7223. SUMMARY: PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 45859 SUPPLEMENTARY INFORMATION: I. Background Section 3086 of the Cures Act (Pub. L. 114–255) added section 565A to the FD&C Act (21 U.S.C. 360bbb–4a). In section 565A of the FD&C Act, Congress encouraged development of material threat MCMs by offering additional incentives for obtaining FDA approval of such products. Under section 565A of the FD&C Act, the sponsor of an eligible material threat MCM application (as defined in section 565A(a)(4)) shall receive a priority review voucher upon approval of the material threat MCM application. The recipient of a material threat MCM priority review voucher may either use the voucher for a future human drug application submitted to FDA under section 505(b)(1) of the FD&C Act (21 U.S.C. 355(b)(1)) or section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)), or transfer (including by sale) the voucher to another party. The voucher may be transferred (including by sale) repeatedly until it ultimately is used for a human drug application submitted to FDA under section 505(b)(1) of the FD&C Act or section 351(a) of the Public Health Service Act. A priority review is a review conducted with a Prescription Drug User Fee Act (PDUFA) goal date of 6 months after the receipt or filing date, depending on the type of application. Information regarding PDUFA goals is available at https://www.fda.gov/ downloads/forindustry/userfees/ prescriptiondruguserfee/ ucm511438.pdf. The applicant that uses a material threat MCM priority review voucher is entitled to a priority review of its eligible human drug application, but must pay FDA a material threat MCM priority review user fee in addition to any user fee required by PDUFA for the application. Information regarding the material threat MCM priority review voucher program is available at: https:// www.fda.gov/EmergencyPreparedness/ Counterterrorism/Medical Countermeasures/MCMLegalRegulatory andPolicyFramework/ ucm566498.htm#prv. This notice establishes the material threat MCM priority review fee rate for FY 2018 at $2,830,579 and outlines FDA’s procedures for payment of material threat MCM priority review user fees. This rate is effective on October 1, 2017, and will remain in effect through September 30, 2018. E:\FR\FM\02OCN1.SGM 02OCN1

Agencies

[Federal Register Volume 82, Number 189 (Monday, October 2, 2017)]
[Notices]
[Pages 45858-45859]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21081]


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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 https://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.gpo.gov/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: CDERDataStandards@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 (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 https://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
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