Medical Device User Fees; Stakeholder Meetings on Medical Device User Fee Amendments of Fiscal Years 2023 to 2027 Reauthorization; Request for Notification of Stakeholder Intention to Participate, 10289-10290 [2021-03428]
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Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices
C. CDRH Guidance
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information (listed in table 4).
Therefore, clearance by OMB under the
PRA (44 U.S.C. 3501–3521) is not
required for this guidance. The
previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in the following FDA
regulations have been approved by OMB
as listed in the following table:
TABLE 4—CDRH GUIDANCE AND COLLECTIONS
COVID–19 guidance title
CFR cite referenced in
COVID–19 guidance
Another guidance title
referenced in COVID–19
guidance
Coagulation Systems for Measurement of
Viscoelastic Properties: Enforcement Policy
During the Coronavirus Disease 2019
(COVID–19) Public Health Emergency (January 2021).
800, 801, and 809 ..................
807, subparts A through D .....
807, subpart E ........................
803 ..........................................
806 ..........................................
820 ..........................................
.................................................
IV. Electronic Access
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 Medical Device
User Fee Amendments (MDUFA). The
statutory authority for MDUFA expires
in September 2022. At that time, new
legislation will be required for FDA to
continue collecting user fees for the
medical device 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 MDUFA
program. The FD&C Act also requires
that FDA hold discussions (at least
every month) with patient and
consumer advocacy groups 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 public
stakeholder representation.
DATES: Submit notification of intention
to participate in these series of meetings
by February 26, 2021. Stakeholder
meetings will be held monthly. It is
anticipated that they will commence in
March 2021. See the SUPPLEMENTARY
INFORMATION section for registration date
and information.
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
MDUFAVReauthorization@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Ellen Olson, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1664, Silver Spring,
MD 20993, 301–796–4322,
MDUFAVReauthorization@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Persons with access to the internet
may obtain COVID–19-related guidances
at:
• FDA web page entitled ‘‘COVID–19Related Guidance Documents for
Industry, FDA Staff, and Other
Stakeholders,’’ available at https://
www.fda.gov/emergency-preparednessand-response/mcm-issues/covid-19related-guidance-documents-industryfda-staff-and-other-stakeholders;
• FDA web page entitled ‘‘Search for
FDA Guidance Documents’’ available at
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments; or
• https://www.regulations.gov.
Dated: February 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–03421 Filed 2–18–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–2253]
Medical Device User Fees; Stakeholder
Meetings on Medical Device User Fee
Amendments of Fiscal Years 2023 to
2027 Reauthorization; Request for
Notification of Stakeholder Intention to
Participate
tkelley on DSKBCP9HB2PROD with NOTICES
AGENCY:
Food and Drug Administration,
HHS.
Notice; request for notification
of participation.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
issuing this notice to request that public
stakeholders—including patient and
SUMMARY:
VerDate Sep<11>2014
21:07 Feb 18, 2021
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PO 00000
Frm 00057
Fmt 4703
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OMB control
No(s).
0910–0485.
0910–0625.
0910–0120.
0910–0437.
0910–0359.
0910–0073.
I. Background
FDA is requesting that public
stakeholders—including patient and
consumer advocacy groups, healthcare
professionals, and scientific and
academic experts—notify the Agency of
their intent to participate in periodic
stakeholder consultation meetings on
the reauthorization of MDUFA. MDUFA
authorizes FDA to collect user fees from
the regulated industry for the process
for the review of medical devices. The
authorization for the current program
(MDUFA IV) expires in September 2022.
Without new legislation, FDA will no
longer be able to collect user fees for
future fiscal years to fund the medical
device review process.
Section 738A(b)(1) of the FD&C Act
(21 U.S.C. 379j–1(b)(1)) requires that
FDA consult with a range of
stakeholders, including representatives
from patient and consumer advocacy
groups, healthcare professionals, and
scientific and academic experts, in
developing recommendations for the
next MDUFA program. FDA initiated
the reauthorization process by holding a
public meeting on October 27, 2020,
where stakeholders and other members
of the public were given an opportunity
to present their views on the
reauthorization. The FD&C Act further
requires that FDA continue meeting
with the representatives of patient and
consumer advocacy groups at least once
every month during negotiations with
the regulated industry to continue
discussions of stakeholder views on the
reauthorization and their suggestions for
changes. It is anticipated that these
monthly stakeholder consultation
meetings will commence in March 2021.
FDA is issuing this Federal Register
notice to request that stakeholder
representatives from patient and
consumer advocacy groups, healthcare
professional associations, as well as
E:\FR\FM\19FEN1.SGM
19FEN1
10290
Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices
scientific and academic experts, notify
FDA of their intent to participate in the
periodic stakeholder consultation
meetings on MDUFA reauthorization.
FDA believes that consistent
stakeholder representation at these
meetings will be important to ensure
progress in these discussions. If you
wish to participate in the stakeholder
consultation meetings, please designate
one or more representatives from your
organization who will commit to
attending these meetings and preparing
for the discussions. Stakeholders who
identify themselves through this notice,
and are otherwise eligible to attend, may
participate in all stakeholder
consultation discussions while FDA
negotiates with the regulated industry.
These stakeholder discussions will
satisfy the consultation requirement in
section 738A(b)(3) of the FD&C Act.
II. Notification of Intent To Participate
in Periodic Stakeholder Consultation
Meetings
If you intend to participate in
continued periodic stakeholder
consultation meetings regarding
MDUFA reauthorization, please provide
notification by email to
MDUFAVReauthorization@fda.hhs.gov
by February 26, 2021. Your email
should contain complete contact
information, including name, title,
affiliation, address, email address,
phone number, and notice of any
special accommodations required
because of disability. Stakeholders will
receive confirmation and additional
information about the first meeting from
FDA after the Agency receives this
notification.
Dated: February 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–03428 Filed 2–18–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–2305]
tkelley on DSKBCP9HB2PROD with NOTICES
Authorizations of Emergency Use of
Certain Drug and Biological Products
During the COVID–19 Pandemic;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of five Emergency Use
SUMMARY:
VerDate Sep<11>2014
21:07 Feb 18, 2021
Jkt 253001
Authorizations (EUAs) (the
Authorizations) under the Federal Food,
Drug, and Cosmetic Act (FD&C Act) for
drug and biological products for use
during the COVID–19 pandemic. FDA
issued one Authorization for a drug as
requested by Baxter Healthcare
Corporation (Baxter); one Authorization
for a biological product as requested by
the Office of the Assistant Secretary for
Preparedness and Response at the U.S.
Department of Health and Human
Services (ASPR/HHS); an Authorization
for a drug and an Authorization for a
biological product as requested by Eli
Lilly and Company; and one
Authorization for biological products as
requested by Regeneron
Pharmaceuticals, Inc. The
Authorizations contain, among other
things, conditions on the emergency use
of the authorized products. The
Authorizations follow the February 4,
2020, determination by the Secretary of
HHS that there is a public health
emergency that has a significant
potential to affect national security or
the health and security of U.S. citizens
living abroad and that involves a novel
(new) coronavirus. The virus, now
named SARS–CoV–2, causes the illness
COVID–19. On the basis of such
determination, the Secretary of HHS
declared on March 27, 2020, that
circumstances exist justifying the
authorization of emergency use of drugs
and biological products during the
COVID–19 pandemic, pursuant to the
FD&C Act, subject to the terms of any
authorization issued under that section.
The Authorizations, which include an
explanation of the reasons for issuance,
are reprinted in this document.
DATES: The Authorization for Baxter is
effective as of August 13, 2020; the
Authorization for ASPR/HHS is
effective as of August 23, 2020; the
Authorizations for Eli Lilly and
Company are effective as of November
9, 2020, and November 19, 2020,
respectively; and the Authorization for
Regeneron Pharmaceuticals, Inc. is
effective as of November 21, 2020.
ADDRESSES: Submit written requests for
single copies of the EUAs to the Office
of Counterterrorism and Emerging
Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1,
Rm. 4338, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your request or include a Fax number to
which the Authorizations may be sent.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the
Authorizations.
FOR FURTHER INFORMATION CONTACT:
Michael Mair, Office of
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
Counterterrorism and Emerging Threats,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 1, Rm.
4340, Silver Spring, MD 20993–0002,
301–796–8510 (this is not a toll free
number).
SUPPLEMENTARY INFORMATION:
I. Background
Section 564 of the FD&C Act (21
U.S.C. 360bbb–3) allows FDA to
strengthen the public health protections
against biological, chemical, nuclear,
and radiological agents. Among other
things, section 564 of the FD&C Act
allows FDA to authorize the use of an
unapproved medical product or an
unapproved use of an approved medical
product in certain situations. With this
EUA authority, FDA can help ensure
that medical countermeasures may be
used in emergencies to diagnose, treat,
or prevent serious or life-threatening
diseases or conditions caused by
biological, chemical, nuclear, or
radiological agents when there are no
adequate, approved, and available
alternatives.
II. Criteria for EUA Authorization
Section 564(b)(1) of the FD&C Act
provides that, before an EUA may be
issued, the Secretary of HHS must
declare that circumstances exist
justifying the authorization based on
one of the following grounds: (1) A
determination by the Secretary of
Homeland Security that there is a
domestic emergency, or a significant
potential for a domestic emergency,
involving a heightened risk of attack
with a biological, chemical, radiological,
or nuclear agent or agents; (2) a
determination by the Secretary of
Defense that there is a military
emergency, or a significant potential for
a military emergency, involving a
heightened risk to U.S. military forces,
including personnel operating under the
authority of title 10 or title 50, U.S.
Code, of attack with (A) a biological,
chemical, radiological, or nuclear agent
or agents; or (B) an agent or agents that
may cause, or are otherwise associated
with, an imminently life-threatening
and specific risk to U.S. military
forces; 1 (3) a determination by the
Secretary of HHS that there is a public
health emergency, or a significant
potential for a public health emergency,
that affects, or has a significant potential
to affect, national security or the health
and security of U.S. citizens living
1 In the case of a determination by the Secretary
of Defense, the Secretary of HHS shall determine
within 45 calendar days of such determination,
whether to make a declaration under section
564(b)(1) of the FD&C Act, and, if appropriate, shall
promptly make such a declaration.
E:\FR\FM\19FEN1.SGM
19FEN1
]]>Agencies
[Federal Register Volume 86, Number 32 (Friday, February 19, 2021)]
[Notices]
[Pages 10289-10290]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03428]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-2253]
Medical Device User Fees; Stakeholder Meetings on Medical Device
User Fee Amendments of Fiscal Years 2023 to 2027 Reauthorization;
Request for Notification of Stakeholder Intention to Participate
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for notification of participation.
-----------------------------------------------------------------------
SUMMARY: 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 Medical Device User
Fee Amendments (MDUFA). The statutory authority for MDUFA expires in
September 2022. At that time, new legislation will be required for FDA
to continue collecting user fees for the medical device 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 MDUFA program. The FD&C Act also requires that FDA hold
discussions (at least every month) with patient and consumer advocacy
groups 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 public
stakeholder representation.
DATES: Submit notification of intention to participate in these series
of meetings by February 26, 2021. Stakeholder meetings will be held
monthly. It is anticipated that they will commence in March 2021. See
the SUPPLEMENTARY INFORMATION section for registration date and
information.
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
[email protected].
FOR FURTHER INFORMATION CONTACT: Ellen Olson, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1664, Silver Spring, MD 20993, 301-796-4322,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is requesting that public stakeholders--including patient and
consumer advocacy groups, healthcare professionals, and scientific and
academic experts--notify the Agency of their intent to participate in
periodic stakeholder consultation meetings on the reauthorization of
MDUFA. MDUFA authorizes FDA to collect user fees from the regulated
industry for the process for the review of medical devices. The
authorization for the current program (MDUFA IV) expires in September
2022. Without new legislation, FDA will no longer be able to collect
user fees for future fiscal years to fund the medical device review
process.
Section 738A(b)(1) of the FD&C Act (21 U.S.C. 379j-1(b)(1))
requires that FDA consult with a range of stakeholders, including
representatives from patient and consumer advocacy groups, healthcare
professionals, and scientific and academic experts, in developing
recommendations for the next MDUFA program. FDA initiated the
reauthorization process by holding a public meeting on October 27,
2020, where stakeholders and other members of the public were given an
opportunity to present their views on the reauthorization. The FD&C Act
further requires that FDA continue meeting with the representatives of
patient and consumer advocacy groups at least once every month during
negotiations with the regulated industry to continue discussions of
stakeholder views on the reauthorization and their suggestions for
changes. It is anticipated that these monthly stakeholder consultation
meetings will commence in March 2021.
FDA is issuing this Federal Register notice to request that
stakeholder representatives from patient and consumer advocacy groups,
healthcare professional associations, as well as
[[Page 10290]]
scientific and academic experts, notify FDA of their intent to
participate in the periodic stakeholder consultation meetings on MDUFA
reauthorization. FDA believes that consistent stakeholder
representation at these meetings will be important to ensure progress
in these discussions. If you wish to participate in the stakeholder
consultation meetings, please designate one or more representatives
from your organization who will commit to attending these meetings and
preparing for the discussions. Stakeholders who identify themselves
through this notice, and are otherwise eligible to attend, may
participate in all stakeholder consultation discussions while FDA
negotiates with the regulated industry. These stakeholder discussions
will satisfy the consultation requirement in section 738A(b)(3) of the
FD&C Act.
II. Notification of Intent To Participate in Periodic Stakeholder
Consultation Meetings
If you intend to participate in continued periodic stakeholder
consultation meetings regarding MDUFA reauthorization, please provide
notification by email to [email protected] by February
26, 2021. Your email should contain complete contact information,
including name, title, affiliation, address, email address, phone
number, and notice of any special accommodations required because of
disability. Stakeholders will receive confirmation and additional
information about the first meeting from FDA after the Agency receives
this notification.
Dated: February 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-03428 Filed 2-18-21; 8:45 am]
BILLING CODE 4164-01-P
