Providing Regulatory Submissions in Electronic Format-Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling; Draft Guidance for Industry; Availability, 41968-41969 [2017-18506]
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41968
Federal Register / Vol. 82, No. 170 / Tuesday, September 5, 2017 / Notices
Dated: August 28, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–18693 Filed 9–1–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–E–4282]
Providing Regulatory Submissions in
Electronic Format—Content of the Risk
Evaluation and Mitigation Strategies
Document Using Structured Product
Labeling; Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Providing Regulatory Submissions in
Electronic Format—Content of the Risk
Evaluation and Mitigation Strategies
Document Using Structured Product
Labeling.’’ This draft guidance is being
issued in accordance with the Food and
Drug Administration Safety and
Innovation Act (FDASIA), which
amended the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) to require
that certain submissions under the
FD&C Act and the Public Health Service
Act (PHS Act) be submitted in
electronic format, beginning no earlier
than 24 months after issuance of final
guidance on electronic format for
submissions. The draft guidance
describes how FDA plans to implement
the requirements for the electronic
submission of Risk Evaluation and
Mitigation Strategies (REMS) documents
in certain submissions under new drug
applications, abbreviated new drug
applications, and biologics license
applications, beginning no earlier than
24 months after issuance of the final
guidance.
SUMMARY:
Submit either electronic or
written comments on the draft guidance
by March 5, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
mstockstill on DSK30JT082PROD with NOTICES
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
VerDate Sep<11>2014
17:43 Sep 01, 2017
Jkt 241001
• 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–E–4282] for ’’ Providing
Regulatory Submissions in Electronic
Format—Content of the Risk Evaluation
and Mitigation Strategies Document
Using Structured Product Labeling;
Draft Guidance for Industry;
Availability.’’ 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 office
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
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
‘‘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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)). Submit written requests
for single copies of the draft guidance to
the Division of Drug Information, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002; or to the Office of
Communication, Outreach and
Development, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Adam Kroetsch, Center for Drug
Evaluation and Research, Food and
Drug Administration, Bldg. 51, Rm.
1168, 10903 New Hampshire Ave.,
Silver Spring, MD 20993–0002, 301–
796–3842; or Aaron Sherman, Center for
Drug Evaluation and Research, Food
and Drug Administration, Bldg. 51, Rm.
E:\FR\FM\05SEN1.SGM
05SEN1
Federal Register / Vol. 82, No. 170 / Tuesday, September 5, 2017 / Notices
6366, 10903 New Hampshire Ave.,
Silver Spring, MD 20993–0002, 240–
402–0493; 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:
mstockstill on DSK30JT082PROD with NOTICES
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Providing Regulatory Submissions in
Electronic Format—Content of the Risk
Evaluation and Mitigation Strategies
Document Using Structured Product
Labeling; Draft Guidance for Industry.’’
FDASIA (Pub. L. 112–144), amended
the FD&C Act to add section 745A (21
U.S.C. 379k–1), entitled ‘‘Electronic
Format for Submissions.’’ Section
745A(a)(1) of the FD&C Act requires that
submissions under section 505(b), (i), or
(j) of the FD&C Act (21 U.S.C. 355(b), (i),
or (j)) and submissions under section
351(a) or (k) of the PHS Act (42 U.S.C.
262(a) or (k)) be submitted to FDA in
electronic format no earlier than 24
months after FDA issues final guidance
on electronic format for submissions. In
accordance with section 745A(a)(1) of
the FD&C Act, FDA is issuing this draft
guidance, announcing its determination
that submission types identified in the
guidance must be submitted
electronically in the format specified in
the guidance beginning 24 months after
the issuance of the final guidance.
This draft guidance (and the technical
specification documents it references)
describes how certain REMS documents
will be required to be submitted in
electronic format using Structured
Product Labeling (SPL) as outlined in
the FDA ‘‘Structured Product Labeling
(SPL) Implementation Guide with
Validation Procedures’’ (available at
https://www.fda.gov/downloads/
ForIndustry/DataStandards/
StructuredProductLabeling/
UCM321876.pdf). (FDA has verified the
Web site addresses, as of the date this
document publishes in the Federal
Register, but Web sites are subject to
change over time.) SPL is a Health Level
7 data standard used by FDA since
2005. For more information on how
FDA interprets section 745A(a) of the
FD&C Act, see the guidance for industry
‘‘Providing Regulatory Submissions in
Electronic Format—Submissions Under
Section745A(a) of the Federal Food,
Drug, and Cosmetic Act’’ (available at
https://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/
UCM384686.pdf).
VerDate Sep<11>2014
17:43 Sep 01, 2017
Jkt 241001
Development of this guidance was
facilitated by completion of the
‘‘Pharmacy Systems Under REMS
Project: Standardizing REMS
Information for Inclusion Into Pharmacy
Systems Using Structured Product
Labeling (SPL).’’ More information on
this project—one of four predefined
priority projects that are a part of the
larger REMS Integration Initiative—can
be found in the report ‘‘Standardizing
and Evaluating Risk Evaluation and
Mitigation Strategies (REMS)’’ (available
at https://www.fda.gov/downloads/
ForIndustry/UserFees/Prescription
DrugUserFee/UCM415751.pdf).
II. Paperwork Reduction Act of 1995
This notice refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 314 have been approved
under OMB control number 0910–0001.
III. Electronic Access
Persons with access to the Internet
may obtain the guidance at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm, or
https://www.regulations.gov.
Dated: August 23, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–18506 Filed 9–1–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–4866]
Pediatric Post-Marketing
Pharmacovigilance and Drug
Utilization Reviews; Establishment of a
Public Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice, establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) is establishing a
public docket to collect comments
related to the pediatric post-marketing
pharmacovigilance and drug utilization
reviews of products posted between
March 11, 2017, and September 12,
SUMMARY:
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
41969
2017, on FDA’s Web site but not
presented at the September 12, 2017,
Pediatric Advisory Committee (PAC)
meeting. These reviews are intended to
be available for review and comment by
members of the PAC, interested parties
(such as academic researchers, regulated
industries, consortia, and patient
groups), and the general public.
DATES: Submit either electronic or
written comments by October 20, 2017.
ADDRESSES: You may submit your
comments as follows. Please note that
late, untimely filed comments will not
be considered. Electronic comments
must be submitted on or before October
20, 2017. The https://
www.regulations.gov electronic filing
system will accept comments until
midnight Eastern Time at the end of
October 20, 2017. 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, you 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 submission 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.
E:\FR\FM\05SEN1.SGM
05SEN1
Agencies
[Federal Register Volume 82, Number 170 (Tuesday, September 5, 2017)]
[Notices]
[Pages 41968-41969]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18506]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-E-4282]
Providing Regulatory Submissions in Electronic Format--Content of
the Risk Evaluation and Mitigation Strategies Document Using Structured
Product Labeling; Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Providing
Regulatory Submissions in Electronic Format--Content of the Risk
Evaluation and Mitigation Strategies Document Using Structured Product
Labeling.'' This draft guidance is being issued in accordance with the
Food and Drug Administration Safety and Innovation Act (FDASIA), which
amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to
require that certain submissions under the FD&C Act and the Public
Health Service Act (PHS Act) be submitted in electronic format,
beginning no earlier than 24 months after issuance of final guidance on
electronic format for submissions. The draft guidance describes how FDA
plans to implement the requirements for the electronic submission of
Risk Evaluation and Mitigation Strategies (REMS) documents in certain
submissions under new drug applications, abbreviated new drug
applications, and biologics license applications, beginning no earlier
than 24 months after issuance of the final guidance.
DATES: Submit either electronic or written comments on the draft
guidance by March 5, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time 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-E-4282] for '' Providing Regulatory Submissions in Electronic
Format--Content of the Risk Evaluation and Mitigation Strategies
Document Using Structured Product Labeling; Draft Guidance for
Industry; Availability.'' 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 office 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.gpo.gov/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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)). Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD
20993-0002; or to the Office of Communication, Outreach and
Development, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Adam Kroetsch, Center for Drug
Evaluation and Research, Food and Drug Administration, Bldg. 51, Rm.
1168, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-
3842; or Aaron Sherman, Center for Drug Evaluation and Research, Food
and Drug Administration, Bldg. 51, Rm.
[[Page 41969]]
6366, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-
0493; 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 announcing the availability of a draft guidance for industry
entitled ``Providing Regulatory Submissions in Electronic Format--
Content of the Risk Evaluation and Mitigation Strategies Document Using
Structured Product Labeling; Draft Guidance for Industry.''
FDASIA (Pub. L. 112-144), amended the FD&C Act to add section 745A
(21 U.S.C. 379k-1), entitled ``Electronic Format for Submissions.''
Section 745A(a)(1) of the FD&C Act requires that submissions under
section 505(b), (i), or (j) of the FD&C Act (21 U.S.C. 355(b), (i), or
(j)) and submissions under section 351(a) or (k) of the PHS Act (42
U.S.C. 262(a) or (k)) be submitted to FDA in electronic format no
earlier than 24 months after FDA issues final guidance on electronic
format for submissions. In accordance with section 745A(a)(1) of the
FD&C Act, FDA is issuing this draft guidance, announcing its
determination that submission types identified in the guidance must be
submitted electronically in the format specified in the guidance
beginning 24 months after the issuance of the final guidance.
This draft guidance (and the technical specification documents it
references) describes how certain REMS documents will be required to be
submitted in electronic format using Structured Product Labeling (SPL)
as outlined in the FDA ``Structured Product Labeling (SPL)
Implementation Guide with Validation Procedures'' (available at https://www.fda.gov/downloads/ForIndustry/DataStandards/StructuredProductLabeling/UCM321876.pdf). (FDA has verified the Web
site addresses, as of the date this document publishes in the Federal
Register, but Web sites are subject to change over time.) SPL is a
Health Level 7 data standard used by FDA since 2005. For more
information on how FDA interprets section 745A(a) of the FD&C Act, see
the guidance for industry ``Providing Regulatory Submissions in
Electronic Format--Submissions Under Section745A(a) of the Federal
Food, Drug, and Cosmetic Act'' (available at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM384686.pdf).
Development of this guidance was facilitated by completion of the
``Pharmacy Systems Under REMS Project: Standardizing REMS Information
for Inclusion Into Pharmacy Systems Using Structured Product Labeling
(SPL).'' More information on this project--one of four predefined
priority projects that are a part of the larger REMS Integration
Initiative--can be found in the report ``Standardizing and Evaluating
Risk Evaluation and Mitigation Strategies (REMS)'' (available at https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM415751.pdf).
II. Paperwork Reduction Act of 1995
This notice refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 314 have been approved under
OMB control number 0910-0001.
III. Electronic Access
Persons with access to the Internet may obtain the guidance at
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.
Dated: August 23, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-18506 Filed 9-1-17; 8:45 am]
BILLING CODE 4164-01-P