Postmarketing Safety Reporting for Combination Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 12292-12294 [2018-05687]
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Federal Register / Vol. 83, No. 55 / Wednesday, March 21, 2018 / Proposed Rules
Q–5 SPAMY,
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HISKU, OR
HAROB, WA
CA to HAROB, WA [Amended]
WP
(Lat. 39°11′57.00″ N, long. 122°37′58.00″
WP
(Lat. 41°20′09.00″ N, long. 122°51′05.00″
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Issued in Washington, DC, on March 13,
2018.
Rodger A. Dean Jr.,
Manager, Airspace Policy Group.
Agency guidances at any time as
follows:
[FR Doc. 2018–05584 Filed 3–20–18; 8:45 am]
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’’).
Electronic Submissions
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 4
[Docket No. FDA–2008–N–0424]
Postmarketing Safety Reporting for
Combination Products; Draft Guidance
for Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notification of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry and FDA staff
entitled ‘‘Postmarketing Safety
Reporting for Combination Products.’’
This draft guidance addresses certain
means by which applicants may comply
with the final rule on postmarketing
safety reporting (PMSR) requirements
for combination products that FDA
issued on December 20, 2016.
Combination products are products
composed of two or more different types
of medical products (drug, device, and/
or biological product). Although the
PMSR regulations for drugs, devices,
and biological products share many
similarities, each set of regulations
establishes distinct postmarketing
reporting requirements, standards, and
timeframes. The final rule provides
clarity on the PMSR requirements for
combination products to ensure
consistent and complete reporting while
avoiding duplication. This draft
guidance is not final nor is it in effect
at this time.
DATES: Submit either electronic or
written comments on the draft guidance
by June 19, 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 either
electronic or written comments on any
sradovich on DSK3GMQ082PROD with PROPOSALS
SUMMARY:
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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–
2008–N–0424 for ‘‘Postmarket Safety
Reporting for Combination Products.’’
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
PO 00000
Frm 00010
Fmt 4702
Sfmt 4702
W)
W)
W)
W)
W)
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/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 Office
of Combination Products, Food and
Drug Administration, Bldg. 32, Rm.
5129, 10903 New Hampshire Ave.,
Silver Spring, MD 20993. Send two selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
E:\FR\FM\21MRP1.SGM
21MRP1
Federal Register / Vol. 83, No. 55 / Wednesday, March 21, 2018 / Proposed Rules
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
sradovich on DSK3GMQ082PROD with PROPOSALS
Melissa Burns, Office of Combination
Products, Food and Drug
Administration, 301–796–5616,
melissa.burns@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry and FDA
staff entitled ‘‘Postmarket Safety
Reporting for Combination Products.’’
This guidance addresses how to comply
with the final rule on postmarketing
safety reporting (PMSR) requirements
for combination products that FDA
issued on December 20, 2016 (81 FR
92603, hereafter referred to as the
‘‘combination product PMSR final
rule’’). Combination products are
products composed of two or more
different types of medical products
(drug, device, and/or biological
product). Although the PMSR
regulations for drugs, devices, and
biological products share many
similarities, each set of regulations
establishes distinct reporting
requirements, standards, and
timeframes. The final rule provides
clarity on the PMSR requirements for
combination products to ensure
consistent and complete reporting while
avoiding duplication.
Elsewhere in this issue of the Federal
Register, FDA is also publishing a
compliance policy guidance for the
combination product PMSR final rule.
The combination product PMSR final
rule applies to combination products
that are subject to premarket review by
FDA. The entities subject to the final
rule are ‘‘Combination Product
Applicants’’ and ‘‘Constituent Part
Applicants.’’ A Combination Product
Applicant holds the only application for
a combination product or all the
applications for the separately marketed
constituent parts of a combination
product. A Constituent Part Applicant
holds an application for a constituent
part of a combination product the
constituent parts of which are marketed
under separate applications held by
different applicants. Major provisions of
the final rule are discussed in the
guidance including:
• Application Type-Based PMSR.
These requirements apply to both
Combination Product Applicants and
Constituent Part Applicants and are
based on the application type under
which the combination product or
constituent part received marketing
authorization.
• Constituent Part-Based PMSR.
These requirements apply only to
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Jkt 244001
Combination Product Applicants and
are based on the types of constituent
parts included in the combination
product. The rule provides mechanisms
for Combination Product Applicants to
submit a single report to satisfy multiple
reporting requirements if all of the
information to be reported can be
submitted in the same manner and the
report satisfies all applicable reporting
requirements, including all submission
timelines.
• Information Sharing. These
requirements apply only to Constituent
Part Applicants, mandating that these
applicants share certain adverse event
information with one another relating to
their combination product.
• Submission Process for
Combination Product PMSR
Information. These requirements specify
how Combination Product and
Constituent Part Applicants must
submit PMSR information to the
Agency.
• Records Retention. These
requirements specify what records
Combination Product and Constituent
Part Applicants must maintain and how
long to maintain them.
II. Other Issues for Consideration
The combination product PMSR final
rule allows FDA to receive complete,
timely postmarketing safety information
regarding combination products, which
is necessary to assure the continued
safety and effectiveness of such
products, while minimizing
unnecessary duplication and burdens
on Combination Product Applicants and
Constituent Part Applicants. In
developing this guidance document to
accompany the final rule, FDA has
clarified ways in which Combination
Product Applicants can streamline
PMSR (see section V.A.3 of the
guidance). The guidance clarifies under
what circumstances the criteria for
being able to submit a single report to
FDA are met, i.e., that: (1) The reports
can be submitted in the same manner
and (2) the combined report satisfies all
applicable reporting requirements,
including submission timelines (see
section IV.C of the guidance). FDA
encourages comments on guidance
content and mechanisms to improve
reporting efficiency while still ensuring
complete and timely reporting or topics
where additional detailed discussion
may be helpful in the guidance. In
particular, FDA requests feedback on
the following issues for consideration to
assist the Agency in determining
whether additional streamlining of
reports may be appropriate:
1. There may be events that would be
reportable for a Combination Product
PO 00000
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12293
Applicant as a malfunction and/or a
Field Alert Report (FAR) and/or a
Biological Product Deviation Report
(BPDR), e.g., a drug-device combination
product that failed to meet
specifications may trigger both a
malfunction report and FAR. FDA
requests feedback on circumstances
under which such reporting may be
redundant or otherwise unnecessary
and, if so, alternative reporting
approaches that will assure timely and
complete reporting of information to
FDA. FDA encourages the use of
example scenarios to illustrate
circumstances under which submitting
one or a subset of such reports may be
sufficient to ensure timely and complete
reporting.
2. Although outside the scope of the
combination product PMSR final rule,
in response to comments to the
combination product PMSR proposed
rule, FDA has addressed certain
reporting considerations for entities
involved with the manufacture and
distribution of combination products
but that are not ‘‘applicants’’ subject to
this rule (see Appendix 3 of the
guidance). FDA requests feedback on
what, if any, additional guidance would
be helpful to such entities.
3. FDA is considering updating the
Vaccine Adverse Event Reporting
System (VAERS) with data elements
similar to those described in section
V.B.2 and Appendix 4 of the guidance
for the FDA Adverse Events Reporting
System (FAERS) and the Electronic
Medical Device Reporting (eMDR)
system. FDA is also evaluating what
additional data elements to include in
VAERS with respect to combination
products and welcomes comments from
combination product vaccine reporters
on this topic.
4. FDA also received comments to the
combination product PMSR proposed
rule related to the safety reporting
requirements for investigational
combination products. Although
investigational combination products
are outside the scope of the combination
product PMSR final rule and this
guidance, we will consider comments
from sponsors on the challenges and the
need for additional transparency related
to safety reporting for investigational
combination products. FDA will
consider these comments in
determining the need for additional
policy and guidance on this topic.
III. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
E:\FR\FM\21MRP1.SGM
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Federal Register / Vol. 83, No. 55 / Wednesday, March 21, 2018 / Proposed Rules
on ‘‘Postmarket Safety Reporting for
Combination Products.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations. This
guidance is not subject to Executive
Order 12866.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
IV. Paperwork Reduction Act of 1995
Regulation of Flavors in Tobacco
Products
This guidance 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 314.80(c) and (e), as well as for
21 CFR 314.81(b) are approved under
OMB control numbers 0910–0001,
0910–0230, and 0910–0291. The
information collection provisions for 21
CFR 600.80 and 600.81 are approved
under OMB control number 0910–0308.
Those for 21 CFR 606.170 are approved
under OMB control number 0910–0116.
Those for 21 CFR 606.171 are approved
under OMB control number 0910–0458.
The information collection provisions
for 21 CFR 803.50, 803.53, and 803.56
are approved under OMB control
numbers 0910–0291 and 0910–0437.
The information collection provisions
for 21 CFR 806.10 and 806.20 are
approved under OMB control number
0910–0359. The information collection
provisions for 21 CFR 4.102, 4.103, and
4.105 are approved under OMB control
number 0910–0834.
V. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Combination
Products/GuidanceRegulatory
Information/ucm109110.htm or https://
www.regulations.gov.
Dated: March 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–05687 Filed 3–20–18; 8:45 am]
sradovich on DSK3GMQ082PROD with PROPOSALS
BILLING CODE 4164–01–P
Food and Drug Administration
21 CFR Parts 1100, 1140, and 1143
[Docket No. FDA–2017–N–6565]
RIN 0910–AH60
AGENCY:
Food and Drug Administration,
HHS.
Advance notice of proposed
rulemaking.
ACTION:
The Food and Drug
Administration (FDA) is issuing this
advance notice of proposed rulemaking
(ANPRM) to obtain information related
to the role that flavors play in tobacco
products. Specifically, this ANPRM is
seeking comments, data, research
results, or other information about,
among other things, how flavors attract
youth to initiate tobacco product use
and about whether and how certain
flavors may help adult cigarette smokers
reduce cigarette use and switch to
potentially less harmful products. FDA
is seeking this information to inform
regulatory actions FDA might take with
respect to tobacco products with flavors,
under the Federal Food, Drug, and
Cosmetic Act (FD&C Act), as amended
by the Family Smoking Prevention and
Tobacco Control Act (Tobacco Control
Act). Potential regulatory actions
include, but are not limited to, tobacco
product standards and restrictions on
sale and distribution of tobacco
products with flavors.
DATES: Submit either electronic or
written comments by June 19, 2018.
ADDRESSES: 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 June 19, 2018.
The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of June 19, 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.
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,
VerDate Sep<11>2014
17:00 Mar 20, 2018
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PO 00000
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Fmt 4702
Sfmt 4702
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–6565 for ‘‘Regulation of Flavors
in Tobacco Products.’’ 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
E:\FR\FM\21MRP1.SGM
21MRP1
]]>Agencies
[Federal Register Volume 83, Number 55 (Wednesday, March 21, 2018)]
[Proposed Rules]
[Pages 12292-12294]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05687]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 4
[Docket No. FDA-2008-N-0424]
Postmarketing Safety Reporting for Combination Products; Draft
Guidance for Industry and Food and Drug Administration Staff;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry and FDA staff
entitled ``Postmarketing Safety Reporting for Combination Products.''
This draft guidance addresses certain means by which applicants may
comply with the final rule on postmarketing safety reporting (PMSR)
requirements for combination products that FDA issued on December 20,
2016. Combination products are products composed of two or more
different types of medical products (drug, device, and/or biological
product). Although the PMSR regulations for drugs, devices, and
biological products share many similarities, each set of regulations
establishes distinct postmarketing reporting requirements, standards,
and timeframes. The final rule provides clarity on the PMSR
requirements for combination products to ensure consistent and complete
reporting while avoiding duplication. This draft guidance is not final
nor is it in effect at this time.
DATES: Submit either electronic or written comments on the draft
guidance by June 19, 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 either electronic or written comments on any
Agency guidances 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-2008-N-0424 for ``Postmarket Safety Reporting for Combination
Products.'' 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 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 Office of Combination Products, Food and Drug Administration, Bldg.
32, Rm. 5129, 10903 New Hampshire Ave., Silver Spring, MD 20993. Send
two self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section
[[Page 12293]]
for electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Melissa Burns, Office of Combination
Products, Food and Drug Administration, 301-796-5616,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
and FDA staff entitled ``Postmarket Safety Reporting for Combination
Products.'' This guidance addresses how to comply with the final rule
on postmarketing safety reporting (PMSR) requirements for combination
products that FDA issued on December 20, 2016 (81 FR 92603, hereafter
referred to as the ``combination product PMSR final rule'').
Combination products are products composed of two or more different
types of medical products (drug, device, and/or biological product).
Although the PMSR regulations for drugs, devices, and biological
products share many similarities, each set of regulations establishes
distinct reporting requirements, standards, and timeframes. The final
rule provides clarity on the PMSR requirements for combination products
to ensure consistent and complete reporting while avoiding duplication.
Elsewhere in this issue of the Federal Register, FDA is also
publishing a compliance policy guidance for the combination product
PMSR final rule.
The combination product PMSR final rule applies to combination
products that are subject to premarket review by FDA. The entities
subject to the final rule are ``Combination Product Applicants'' and
``Constituent Part Applicants.'' A Combination Product Applicant holds
the only application for a combination product or all the applications
for the separately marketed constituent parts of a combination product.
A Constituent Part Applicant holds an application for a constituent
part of a combination product the constituent parts of which are
marketed under separate applications held by different applicants.
Major provisions of the final rule are discussed in the guidance
including:
Application Type-Based PMSR. These requirements apply to
both Combination Product Applicants and Constituent Part Applicants and
are based on the application type under which the combination product
or constituent part received marketing authorization.
Constituent Part-Based PMSR. These requirements apply only
to Combination Product Applicants and are based on the types of
constituent parts included in the combination product. The rule
provides mechanisms for Combination Product Applicants to submit a
single report to satisfy multiple reporting requirements if all of the
information to be reported can be submitted in the same manner and the
report satisfies all applicable reporting requirements, including all
submission timelines.
Information Sharing. These requirements apply only to
Constituent Part Applicants, mandating that these applicants share
certain adverse event information with one another relating to their
combination product.
Submission Process for Combination Product PMSR
Information. These requirements specify how Combination Product and
Constituent Part Applicants must submit PMSR information to the Agency.
Records Retention. These requirements specify what records
Combination Product and Constituent Part Applicants must maintain and
how long to maintain them.
II. Other Issues for Consideration
The combination product PMSR final rule allows FDA to receive
complete, timely postmarketing safety information regarding combination
products, which is necessary to assure the continued safety and
effectiveness of such products, while minimizing unnecessary
duplication and burdens on Combination Product Applicants and
Constituent Part Applicants. In developing this guidance document to
accompany the final rule, FDA has clarified ways in which Combination
Product Applicants can streamline PMSR (see section V.A.3 of the
guidance). The guidance clarifies under what circumstances the criteria
for being able to submit a single report to FDA are met, i.e., that:
(1) The reports can be submitted in the same manner and (2) the
combined report satisfies all applicable reporting requirements,
including submission timelines (see section IV.C of the guidance). FDA
encourages comments on guidance content and mechanisms to improve
reporting efficiency while still ensuring complete and timely reporting
or topics where additional detailed discussion may be helpful in the
guidance. In particular, FDA requests feedback on the following issues
for consideration to assist the Agency in determining whether
additional streamlining of reports may be appropriate:
1. There may be events that would be reportable for a Combination
Product Applicant as a malfunction and/or a Field Alert Report (FAR)
and/or a Biological Product Deviation Report (BPDR), e.g., a drug-
device combination product that failed to meet specifications may
trigger both a malfunction report and FAR. FDA requests feedback on
circumstances under which such reporting may be redundant or otherwise
unnecessary and, if so, alternative reporting approaches that will
assure timely and complete reporting of information to FDA. FDA
encourages the use of example scenarios to illustrate circumstances
under which submitting one or a subset of such reports may be
sufficient to ensure timely and complete reporting.
2. Although outside the scope of the combination product PMSR final
rule, in response to comments to the combination product PMSR proposed
rule, FDA has addressed certain reporting considerations for entities
involved with the manufacture and distribution of combination products
but that are not ``applicants'' subject to this rule (see Appendix 3 of
the guidance). FDA requests feedback on what, if any, additional
guidance would be helpful to such entities.
3. FDA is considering updating the Vaccine Adverse Event Reporting
System (VAERS) with data elements similar to those described in section
V.B.2 and Appendix 4 of the guidance for the FDA Adverse Events
Reporting System (FAERS) and the Electronic Medical Device Reporting
(eMDR) system. FDA is also evaluating what additional data elements to
include in VAERS with respect to combination products and welcomes
comments from combination product vaccine reporters on this topic.
4. FDA also received comments to the combination product PMSR
proposed rule related to the safety reporting requirements for
investigational combination products. Although investigational
combination products are outside the scope of the combination product
PMSR final rule and this guidance, we will consider comments from
sponsors on the challenges and the need for additional transparency
related to safety reporting for investigational combination products.
FDA will consider these comments in determining the need for additional
policy and guidance on this topic.
III. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA
[[Page 12294]]
on ``Postmarket Safety Reporting for Combination Products.'' It does
not establish any rights for any person and is not binding on FDA or
the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.
IV. Paperwork Reduction Act of 1995
This guidance 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 314.80(c) and (e), as well as for
21 CFR 314.81(b) are approved under OMB control numbers 0910-0001,
0910-0230, and 0910-0291. The information collection provisions for 21
CFR 600.80 and 600.81 are approved under OMB control number 0910-0308.
Those for 21 CFR 606.170 are approved under OMB control number 0910-
0116. Those for 21 CFR 606.171 are approved under OMB control number
0910-0458. The information collection provisions for 21 CFR 803.50,
803.53, and 803.56 are approved under OMB control numbers 0910-0291 and
0910-0437. The information collection provisions for 21 CFR 806.10 and
806.20 are approved under OMB control number 0910-0359. The information
collection provisions for 21 CFR 4.102, 4.103, and 4.105 are approved
under OMB control number 0910-0834.
V. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm109110.htm or https://www.regulations.gov.
Dated: March 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-05687 Filed 3-20-18; 8:45 am]
BILLING CODE 4164-01-P
