Recognition and Withdrawal of Voluntary Consensus Standards; Guidance for Industry and Food and Drug Administration Staff; Availability, 57218-57219 [2020-20308]
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Federal Register / Vol. 85, No. 179 / Tuesday, September 15, 2020 / Notices
manufactured by Vertex
Pharmaceutical, Inc., meets the criteria
for a priority review voucher.
TRIKAFTA (elexacaftor/tezacaftor/
ivacaftor) is indicated for the treatment
of patients with cystic fibrosis aged 12
years and older who have at least one
F508del mutation in the cystic fibrosis
transmembrane conductance regulator
gene.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsforRareDiseases
Conditions/RarePediatricDiseasePriority
VoucherProgram/default.htm. For
further information about TRIKAFTA
(elexacaftor/tezacaftor/ivacaftor), go to
the ‘‘Drugs@FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
Dated: September 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–20320 Filed 9–14–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–2936]
Recognition and Withdrawal of
Voluntary Consensus Standards;
Guidance for Industry and Food and
Drug Administration Staff; 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 final
guidance entitled ‘‘Recognition and
Withdrawal of Voluntary Consensus
Standards; Guidance for Industry and
Food and Drug Administration Staff.’’
This guidance identifies the principles
FDA uses for recognizing a standard,
and it explains the extent of recognition
and other supplementary information. It
provides information on how you may
request recognition as well as
circumstances under which FDA may
withdraw recognition. This guidance
also responds to a provision of the 21st
Century Cures Act (Cures Act) by
updating published guidance on these
topics.
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
The announcement of the
guidance is published in the Federal
Register on September 15, 2020.
DATES:
VerDate Sep<11>2014
16:57 Sep 14, 2020
Jkt 250001
You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
ADDRESSES:
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–
2018–D–2936 for ‘‘Recognition and
Withdrawal of Voluntary Consensus
Standards; Guidance for Industry and
Food and Drug Administration Staff.’’
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
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
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.govinfo.gov/content/pkg/FR-201509-18/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)).
An electronic copy of the guidance
document is available for download
from the internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the guidance
document entitled ‘‘Recognition and
Withdrawal of Voluntary Consensus
Standards; Guidance for Industry and
Food and Drug Administration Staff’’ to
the Office of Policy, Guidance and
Policy Development, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request.
FOR FURTHER INFORMATION CONTACT:
Scott Colburn, Center for Devices and
E:\FR\FM\15SEN1.SGM
15SEN1
Federal Register / Vol. 85, No. 179 / Tuesday, September 15, 2020 / Notices
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5606, Silver Spring,
MD 20993–0002, 301–796–6287 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, 240–402–
7911.
SUPPLEMENTARY INFORMATION:
jbell on DSKJLSW7X2PROD with NOTICES
I. Background
FDA’s standards recognition program
furthers the aim of international
harmonization because the same
standards (or international equivalents)
are relied upon by sponsors to meet
other countries’ regulatory requirements
when appropriate. This guidance
describes the procedures that FDA
follows and the actions FDA may take
to recognize and withdraw recognition
from voluntary consensus standards.
This guidance provides further clarity
and explanation about the regulatory
framework, policies, and practices when
evaluating requests for recognition. This
guidance also responds to section 3053
of the Cures Act by updating published
guidance on these topics (Pub. L. 114–
255).
FDA generally considers for
recognition voluntary consensus
standards, which are created by
standards development organizations
that follow a consensus process. A
document issued by the Office of
Management and Budget (OMB) entitled
‘‘Federal Participation in the
Development and Use of Voluntary
Consensus Standards and in Conformity
Assessment Activities,’’ commonly
called OMB Circular A–119, defines the
attributes or elements of a consensus
process (Ref. 1). This guidance explains
those elements and how they pertain to
FDA’s consideration of a standard for
recognition.
The guidance describes the process
leading up to and including recognition.
We list common purposes to recognize
voluntary consensus standards as well
as the essential information that FDA
will provide in the supplemental
information sheet for the recognition of
a standard. This guidance also discusses
when FDA may withdraw recognition.
Any interested party may also request
that FDA recognize a specific voluntary
consensus standard. This guidance
recommends the information that
should be included in a request for
recognition of a standard, and it
summarizes the actions we may take to
act on such a request.
A notice of availability of the draft
guidance appeared in the Federal
VerDate Sep<11>2014
16:57 Sep 14, 2020
Jkt 250001
Register of September 14, 2018 (83 FR
46740). FDA considered comments
received and revised the guidance as
appropriate in response to the
comments, including specifying that
FDA will provide the rationale for
complete and partial recognition and
describing considerations for
determining the timing of a transition
period between versions of standards.
This guidance supersedes the guidance
‘‘CDRH Standard Operating Procedures
for the Identification and Evaluation of
Candidate Consensus Standards for
Recognition,’’ issued on September 17,
2007.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Recognition and
Withdrawal of Voluntary Consensus
Standards; Guidance for Industry and
Food and Drug Administration Staff.’’ 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.
II. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by
downloading an electronic copy from
the internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm. This
guidance document is also available at
https://www.regulations.gov or https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances. Persons unable to download
an electronic copy of ‘‘Recognition and
Withdrawal of Voluntary Consensus
Standards; Guidance for Industry and
Food and Drug Administration Staff’’
may send an email request to CDRHGuidance@fda.hhs.gov to receive an
electronic copy of the document. Please
use the document number 616 and full
title to identify the guidance you are
requesting.
III. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information.
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. 3501–3521). The collections
of information in the following FDA
guidance have been approved by OMB
control number 0910–0120.
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
57219
Dated: September 3, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020–20308 Filed 9–14–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1861]
Generic Drug User Fees; Stakeholder
Meetings on Generic Drug User Fee
Amendments of 2017 Reauthorization;
Request for Notification of Stakeholder
Intention To Participate
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice; request for notification
of participation.
AGENCY:
The Food and Drug
Administration (FDA or Agency) is
issuing this notice to request that public
stakeholders, including patient and
consumer advocacy groups, healthcare
professionals, and scientific and
academic experts notify FDA of their
intent to participate in periodic
consultation meetings on the
reauthorization of the Generic Drug User
Fee Amendments of 2017 (GDUFA). At
the end of September 2022, new
legislation will be required for FDA to
continue collecting generic drug user
fees for subsequent fiscal years for the
generic drug program. The Federal
Food, Drug, and Cosmetic Act (FD&C
Act) requires that FDA consult with a
range of stakeholders in developing
recommendations for the next GDUFA
program. The FD&C Act also requires
that FDA hold continued discussions
with patient and consumer advocacy
groups at least monthly during FDA’s
negotiations with the regulated
industry. The purpose of this request for
notification is to ensure continuity and
progress in these monthly discussions
by establishing consistent stakeholder
representation.
SUMMARY:
Submit notification of intention
to participate in these series of meetings
by October 8, 2020. Stakeholder
meetings will be held monthly, and it is
anticipated that they will commence in
October 2020.
ADDRESSES: The meetings will take
place virtually and will be held by
webcast only. Submit notification of
intention to participate in monthly
stakeholder meetings by email to
GenericDrugPolicy@fda.hhs.gov. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
DATES:
E:\FR\FM\15SEN1.SGM
15SEN1
]]>Agencies
[Federal Register Volume 85, Number 179 (Tuesday, September 15, 2020)]
[Notices]
[Pages 57218-57219]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20308]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-2936]
Recognition and Withdrawal of Voluntary Consensus Standards;
Guidance for Industry and Food and Drug Administration Staff;
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 final guidance entitled ``Recognition and
Withdrawal of Voluntary Consensus Standards; Guidance for Industry and
Food and Drug Administration Staff.'' This guidance identifies the
principles FDA uses for recognizing a standard, and it explains the
extent of recognition and other supplementary information. It provides
information on how you may request recognition as well as circumstances
under which FDA may withdraw recognition. This guidance also responds
to a provision of the 21st Century Cures Act (Cures Act) by updating
published guidance on these topics.
DATES: The announcement of the guidance is published in the Federal
Register on September 15, 2020.
ADDRESSES: You may submit either electronic or written comments on
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-2018-D-2936 for ``Recognition and Withdrawal of Voluntary Consensus
Standards; Guidance for Industry and Food and Drug Administration
Staff.'' 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.govinfo.gov/content/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)).
An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Recognition and Withdrawal of Voluntary Consensus Standards; Guidance
for Industry and Food and Drug Administration Staff'' to the Office of
Policy, Guidance and Policy Development, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
request.
FOR FURTHER INFORMATION CONTACT: Scott Colburn, Center for Devices and
[[Page 57219]]
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5606, Silver Spring, MD 20993-0002, 301-796-6287 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, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA's standards recognition program furthers the aim of
international harmonization because the same standards (or
international equivalents) are relied upon by sponsors to meet other
countries' regulatory requirements when appropriate. This guidance
describes the procedures that FDA follows and the actions FDA may take
to recognize and withdraw recognition from voluntary consensus
standards. This guidance provides further clarity and explanation about
the regulatory framework, policies, and practices when evaluating
requests for recognition. This guidance also responds to section 3053
of the Cures Act by updating published guidance on these topics (Pub.
L. 114-255).
FDA generally considers for recognition voluntary consensus
standards, which are created by standards development organizations
that follow a consensus process. A document issued by the Office of
Management and Budget (OMB) entitled ``Federal Participation in the
Development and Use of Voluntary Consensus Standards and in Conformity
Assessment Activities,'' commonly called OMB Circular A-119, defines
the attributes or elements of a consensus process (Ref. 1). This
guidance explains those elements and how they pertain to FDA's
consideration of a standard for recognition.
The guidance describes the process leading up to and including
recognition. We list common purposes to recognize voluntary consensus
standards as well as the essential information that FDA will provide in
the supplemental information sheet for the recognition of a standard.
This guidance also discusses when FDA may withdraw recognition.
Any interested party may also request that FDA recognize a specific
voluntary consensus standard. This guidance recommends the information
that should be included in a request for recognition of a standard, and
it summarizes the actions we may take to act on such a request.
A notice of availability of the draft guidance appeared in the
Federal Register of September 14, 2018 (83 FR 46740). FDA considered
comments received and revised the guidance as appropriate in response
to the comments, including specifying that FDA will provide the
rationale for complete and partial recognition and describing
considerations for determining the timing of a transition period
between versions of standards. This guidance supersedes the guidance
``CDRH Standard Operating Procedures for the Identification and
Evaluation of Candidate Consensus Standards for Recognition,'' issued
on September 17, 2007.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Recognition and Withdrawal of Voluntary
Consensus Standards; Guidance for Industry and Food and Drug
Administration Staff.'' 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.
II. Electronic Access
Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.regulations.gov or
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances. Persons unable to
download an electronic copy of ``Recognition and Withdrawal of
Voluntary Consensus Standards; Guidance for Industry and Food and Drug
Administration Staff'' may send an email request to [email protected] to receive an electronic copy of the document.
Please use the document number 616 and full title to identify the
guidance you are requesting.
III. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information. 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. 3501-3521). The collections of information in
the following FDA guidance have been approved by OMB control number
0910-0120.
Dated: September 3, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-20308 Filed 9-14-20; 8:45 am]
BILLING CODE 4164-01-P
