82 FR 47528 - Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards; Public Meeting; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 196 (October 12, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 196 (October 12, 2017)
| Page Range | 47528-47529 | |
| FR Document | 2017-21981 |
[Federal Register Volume 82, Number 196 (Thursday, October 12, 2017)] [Notices] [Pages 47528-47529] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-21981] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-5568] Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the following public meeting entitled ``Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards.'' The topics to be discussed will include the current status of electronic submissions and data standards initiatives to improve the predictability and consistency of the electronic submissions process in support of the human drug review program. FDA is seeking input from a variety of stakeholders--industry, academia, patient advocates, professional societies and other interested parties--as it fulfills its commitment under the Prescription Drug User Fee Act of 2017 (PDUFA) to hold annual public meetings to seek stakeholder input related to enhancing the transparency and accountability of the electronic submission and data standards activities. FDA will use the information from the public meeting to inform the development of the FDA Information Technology (FDA IT) Strategic Plan and electronic submissions gateway target timeframes. DATES: The public meeting will be held March 21, 2018, from 9 a.m. to 4 p.m. Submit either electronic or written comments regarding this public meeting prior to the meeting through April 18, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The public meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503, Section A), Silver Spring, MD 20993-0002. Entrance for the public meeting participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed. For parking and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/default.htm. You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 18, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of April 18, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. 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-5568 for ``Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards.'' Received comments, those filed in a timely manner (see ADDRESSES), 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 Dockets Management Staff. 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 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 [[Page 47529]] 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; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240- 402-7911. SUPPLEMENTARY INFORMATION: I. Background FDA is committed to achieve the long-term goal of improving the predictability and consistency of the electronic submission process, and enhancing transparency and accountability of FDA information technology related activities. FDA agreed in the PDUFA VI commitment letter to hold annual public meetings to seek stakeholder input related to electronic submissions and data standards to inform the FDA IT Strategic Plan and published targets. The commitment letter outlines FDA's performance goals and procedures under the PDUFA program for the years 2018-2022. The commitment letter can be found at https://www.fda.gov/forindustry/userfees/prescriptiondruguserfee/ucm446608.htm. II. Topics for Discussion at the Public Meeting FDA strives to achieve a fully automated standards-based IT environment that enhances the regulatory review processes for human drugs and biologics. The purpose of the March 21, 2018, public meeting is to obtain input from industry and other interested stakeholders on enhancing the transparency and accountability of the electronic submission and data standards activities. To help fulfill its commitment, FDA is particularly interested in receiving input on the following topics: Electronic Submissions [cir] Electronic submission process, including key electronic submission milestones and associated sponsor notifications from the completion of the upload of the submission to the Electronic Submissions Gateway (ESG) through the time the submission is made available to the review team. [cir] Electronic submission system past performance, emerging industry needs, and technology initiatives. [cir] Published and future targets for the ESG and related electronic submission systems. [cir] Implementation of electronic Common Technical Document (eCTD) v4.0. Data Standards Initiatives [cir] International Organization for Standards (ISO) Identification of Medicinal Products (IDMP): ISO IDMP standards implementation will support a variety of regulatory activities related to development, registration, and life cycle management of medicinal products, as well as pharmacovigilance and risk management. There are five standards that describe the substance (ISO 11238), dosage form and routes of administration (ISO 11239), units of measure (ISO 11240), medicinal product identifier (ISO 11615), and pharmaceutical product identifier (ISO 11616). [cir] Individual Case Safety Reports (ICSRs): ICSRs provide a consistent approach to the creation and review of drug and biologics safety information and pharmacovigilance activities. FDA will consider all comments made at this workshop or received through the docket (see ADDRESSES). III. Participating in the Public Meeting Registration: To register to attend ``Prescription Drug User Fee Act VI; Electronic Submissions and Data Standards; Public Meeting; Request for Comments'' please send an email to cderdatastandards@fda.hhs.gov by February 19, 2018. 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 meeting must register by February 19, 2018, midnight Eastern Time. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. If you need special accommodations due to a disability, please contact Chenoa Conley, 301-796-0035, email Chenoa.Conley@fda.hhs.gov at least 7 days before the meeting. Request for Oral Presentations: During online registration you may indicate if you wish to present during the public comment session and which topic(s) you wish to address. FDA will do its best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations. Following the close of registration, FDA will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will select and notify participants by March 6, 2018. All requests to make oral presentations must be received by the close of registration on February 19, 2018, midnight Eastern Time. If selected for presentation, any presentation materials must be emailed to cderdatastandards@fda.hhs.gov no later than March 14, 2018. No commercial or promotional material will be permitted to be presented or distributed at the public meeting. Transcripts: Please be advised that as soon as a transcript of the public meeting 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/forindustry/userfees/prescriptiondruguserfee/ucm446608.htm. Dated: October 5, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-21981 Filed 10-11-17; 8:45 am] BILLING CODE 4164-01-P
![47528 Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices
proposed information collection should 10903 New Hampshire Ave., Bldg. 31 Staff, FDA will post your comment, as
be sent directly to the following: Office Conference Center, the Great Room (Rm. well as any attachments, except for
of Management and Budget, Paperwork 1503, Section A), Silver Spring, MD information submitted, marked and
Reduction Project, Email: OIRA_ 20993–0002. Entrance for the public identified, as confidential, if submitted
SUBMISSION@OMB.EOP.GOV, Attn: meeting participants (non-FDA as detailed in ‘‘Instructions.’’
Desk Officer for the Administration for employees) is through Building 1, where Instructions: All submissions received
Children and Families. routine security check procedures will must include the Docket No. FDA–
Mary Jones,
be performed. For parking and security 2017–N–5568 for ‘‘Prescription Drug
information, please refer to https:// User Fee Act of 2017; Electronic
Reports Clearance Officer.
www.fda.gov/AboutFDA/WorkingatFDA Submissions and Data Standards.’’
[FR Doc. 2017–21960 Filed 10–11–17; 8:45 am]
/BuildingsandFacilities/WhiteOak Received comments, those filed in a
BILLING CODE 4184–41–P
CampusInformation/default.htm. timely manner (see ADDRESSES), will be
You may submit comments as placed in the docket and, except for
follows. Please note that late, untimely those submitted as ‘‘Confidential
DEPARTMENT OF HEALTH AND filed comments will not be considered. Submissions,’’ publicly viewable at
HUMAN SERVICES Electronic comments must be submitted https://www.regulations.gov or at the
Food and Drug Administration on or before April 18, 2018. The https:// Dockets Management Staff between 9
www.regulations.gov electronic filing a.m. and 4 p.m., Monday through
[Docket No. FDA–2017–N–5568] system will accept comments until Friday.
midnight Eastern Time at the end of • Confidential Submissions—To
Prescription Drug User Fee Act of April 18, 2018. Comments received by submit a comment with confidential
2017; Electronic Submissions and Data mail/hand delivery/courier (for written/ information that you do not wish to be
Standards; Public Meeting; Request paper submissions) will be considered made publicly available, submit your
for Comments timely if they are postmarked or the comments only as a written/paper
AGENCY: Food and Drug Administration, delivery service acceptance receipt is on submission. You should submit two
HHS. or before that date. copies total. One copy will include the
ACTION: Notice of public meeting. Electronic Submissions information you claim to be confidential
with a heading or cover note that states
SUMMARY: The Food and Drug Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
Administration (FDA or Agency) is following way: CONFIDENTIAL INFORMATION.’’ The
announcing the following public • Federal eRulemaking Portal: Agency will review this copy, including
meeting entitled ‘‘Prescription Drug https://www.regulations.gov. Follow the the claimed confidential information, in
User Fee Act of 2017; Electronic instructions for submitting comments. its consideration of comments. The
Submissions and Data Standards.’’ The Comments submitted electronically, second copy, which will have the
topics to be discussed will include the including attachments, to https:// claimed confidential information
current status of electronic submissions www.regulations.gov will be posted to redacted/blacked out, will be available
and data standards initiatives to the docket unchanged. Because your for public viewing and posted on
improve the predictability and comment will be made public, you are https://www.regulations.gov. Submit
consistency of the electronic solely responsible for ensuring that your both copies to the Dockets Management
submissions process in support of the comment does not include any Staff. If you do not wish your name and
human drug review program. FDA is confidential information that you or a contact information to be made publicly
seeking input from a variety of third party may not wish to be posted, available, you can provide this
stakeholders—industry, academia, such as medical information, your or information on the cover sheet and not
patient advocates, professional societies anyone else’s Social Security number, or in the body of your comments and you
and other interested parties—as it confidential business information, such must identify this information as
fulfills its commitment under the as a manufacturing process. Please note ‘‘confidential.’’ Any information marked
Prescription Drug User Fee Act of 2017 that if you include your name, contact as ‘‘confidential’’ will not be disclosed
(PDUFA) to hold annual public information, or other information that except in accordance with 21 CFR 10.20
meetings to seek stakeholder input identifies you in the body of your and other applicable disclosure law. For
related to enhancing the transparency comments, that information will be more information about FDA’s posting
and accountability of the electronic posted on https://www.regulations.gov. of comments to public dockets, see 80
submission and data standards • If you want to submit a comment FR 56469, September 18, 2015, or access
activities. FDA will use the information with confidential information that you the information at: https://www.gpo.gov
from the public meeting to inform the do not wish to be made available to the /fdsys/pkg/FR-2015-09-18/pdf/2015-233
development of the FDA Information public, submit the comment as a 89.pdf.
Technology (FDA IT) Strategic Plan and written/paper submission and in the Docket: For access to the docket to
electronic submissions gateway target manner detailed (see ‘‘Written/Paper read background documents or the
timeframes. Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
DATES: The public meeting will be held Written/Paper Submissions received, go to https://
March 21, 2018, from 9 a.m. to 4 p.m. www.regulations.gov and insert the
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Submit written/paper submissions as
Submit either electronic or written follows: docket number, found in brackets in the
comments regarding this public meeting • Mail/Hand delivery/Courier (for heading of this document, into the
prior to the meeting through April 18, written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts
2018. See the SUPPLEMENTARY Management Staff (HFA–305), Food and and/or go to the Dockets Management
INFORMATION section for registration date Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061,
and information. Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852.
ADDRESSES: The public meeting will be • For written/paper comments FOR FURTHER INFORMATION CONTACT: Ron
held at the FDA White Oak Campus, submitted to the Dockets Management Fitzmartin, Center for Drug Evaluation
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![Federal Register / Vol. 82, No. 196 / Thursday, October 12, 2017 / Notices 47529
and Research, Food and Drug • Data Standards Initiatives will select and notify participants by
Administration, 10903 New Hampshire Æ International Organization for March 6, 2018. All requests to make oral
Ave., Bldg. 51, Rm. 1115, Silver Spring, Standards (ISO) Identification of presentations must be received by the
MD 20993–0002, 301–796–5333, email: Medicinal Products (IDMP): ISO IDMP close of registration on February 19,
cderdatastandards@fda.hhs.gov; or standards implementation will support 2018, midnight Eastern Time. If selected
Stephen Ripley, Center for Biologics a variety of regulatory activities related for presentation, any presentation
Evaluation and Research, Food and to development, registration, and life materials must be emailed to
Drug Administration, 10903 New cycle management of medicinal cderdatastandards@fda.hhs.gov no later
Hampshire Ave., Bldg. 71, Rm. 7301, products, as well as pharmacovigilance than March 14, 2018. No commercial or
Silver Spring, MD 20993–0002, 240– and risk management. There are five promotional material will be permitted
402–7911. standards that describe the substance to be presented or distributed at the
SUPPLEMENTARY INFORMATION: (ISO 11238), dosage form and routes of public meeting.
administration (ISO 11239), units of Transcripts: Please be advised that as
I. Background measure (ISO 11240), medicinal product soon as a transcript of the public
FDA is committed to achieve the long- identifier (ISO 11615), and meeting is available, it will be accessible
term goal of improving the pharmaceutical product identifier (ISO at https://www.regulations.gov. It may
predictability and consistency of the 11616). be viewed at the Dockets Management
electronic submission process, and Æ Individual Case Safety Reports Staff (see ADDRESSES). A link to the
enhancing transparency and (ICSRs): ICSRs provide a consistent transcript will also be available on the
accountability of FDA information approach to the creation and review of internet at https://www.fda.gov/
technology related activities. FDA drug and biologics safety information forindustry/userfees/prescriptiondrug
agreed in the PDUFA VI commitment and pharmacovigilance activities. userfee/ucm446608.htm.
letter to hold annual public meetings to FDA will consider all comments made
at this workshop or received through the Dated: October 5, 2017.
seek stakeholder input related to
docket (see ADDRESSES). Leslie Kux,
electronic submissions and data
standards to inform the FDA IT Strategic Associate Commissioner for Policy.
III. Participating in the Public Meeting
Plan and published targets. The [FR Doc. 2017–21981 Filed 10–11–17; 8:45 am]
commitment letter outlines FDA’s Registration: To register to attend BILLING CODE 4164–01–P
performance goals and procedures ‘‘Prescription Drug User Fee Act VI;
under the PDUFA program for the years Electronic Submissions and Data
2018–2022. The commitment letter can Standards; Public Meeting; Request for DEPARTMENT OF HEALTH AND
be found at https://www.fda.gov/for Comments’’ please send an email to HUMAN SERVICES
industry/userfees/prescriptiondrug cderdatastandards@fda.hhs.gov by
February 19, 2018. Please provide Food and Drug Administration
userfee/ucm446608.htm.
complete contact information for each [Docket No. FDA–2009–D–0461]
II. Topics for Discussion at the Public attendee, including name, title,
Meeting affiliation, address, email, and Format and Content of a Risk
FDA strives to achieve a fully telephone. Evaluation and Mitigation Strategy
automated standards-based IT Registration is free and based on Document; Revised Draft Guidance for
environment that enhances the space availability, with priority given to Industry; Availability
regulatory review processes for human early registrants. Persons interested in
attending this public meeting must AGENCY: Food and Drug Administration,
drugs and biologics. The purpose of the
register by February 19, 2018, midnight HHS.
March 21, 2018, public meeting is to
obtain input from industry and other Eastern Time. Early registration is ACTION: Notice of availability.
interested stakeholders on enhancing recommended because seating is
limited; therefore, FDA may limit the SUMMARY: The Food and Drug
the transparency and accountability of Administration (FDA or Agency) is
the electronic submission and data number of participants from each
organization. Registrants will receive announcing the availability of a revised
standards activities. To help fulfill its draft guidance for industry entitled
commitment, FDA is particularly confirmation when they have been
accepted. ‘‘Format and Content of a REMS
interested in receiving input on the Document.’’ A Risk Evaluation and
following topics: If you need special accommodations
Mitigation Strategy (REMS) document,
• Electronic Submissions due to a disability, please contact
Æ Electronic submission process, Chenoa Conley, 301–796–0035, email which is part of a REMS that is required
including key electronic submission Chenoa.Conley@fda.hhs.gov at least 7 by FDA, establishes the goals and
milestones and associated sponsor days before the meeting. requirements of the REMS. This revised
notifications from the completion of the Request for Oral Presentations: During draft guidance describes a new
upload of the submission to the online registration you may indicate if recommended format for a REMS
Electronic Submissions Gateway (ESG) you wish to present during the public document. The new format was
through the time the submission is comment session and which topic(s) developed based on extensive
made available to the review team. you wish to address. FDA will do its stakeholder feedback. This guidance
revises and supersedes the draft
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Æ Electronic submission system past best to accommodate requests to make
performance, emerging industry needs, public comments. Individuals and guidance entitled ‘‘Format and Content
and technology initiatives. organizations with common interests are of Proposed Risk Evaluation and
Æ Published and future targets for the urged to consolidate or coordinate their Mitigation Strategies (REMS), REMS
ESG and related electronic submission presentations. Following the close of Assessments, and Proposed REMS
systems. registration, FDA will determine the Modifications,’’ that was published by
Æ Implementation of electronic amount of time allotted to each FDA on October 1, 2009.
Common Technical Document (eCTD) presenter and the approximate time DATES: Submit either electronic or
v4.0. each oral presentation is to begin, and written comments on the draft guidance
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Document Created: 2018-10-25 10:06:35
Document Modified: 2018-10-25 10:06:35
| 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 of public meeting. | |
| Dates | The public meeting will be held March 21, 2018, from 9 a.m. to 4 p.m. Submit either electronic or written comments regarding this public meeting prior to the meeting through April 18, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and 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]; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240- 402-7911. | |
| FR Citation | 82 FR 47528 |
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