National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting, 20177 [2021-07888]
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Federal Register / Vol. 86, No. 72 / Friday, April 16, 2021 / Notices
effectiveness, and considers the factors
identified in the January 21, 1998, FR
notice (63 FR 3142), and as explained in
FDA’s guidance ‘‘Procedures for Class II
Device Exemptions from Premarket
Notification,’’ including whether (1) the
device has had a significant history of
false or misleading claims or of risks
associated with inherent characteristics
of the device; (2) any device
characteristics necessary for its safe and
effective performance are well
established; (3) any changes in the
device that could affect safety and
effectiveness will either (a) be readily
detectable by users by visual
examination or other means such as
routine testing, before causing harm, or
(b) not materially increase the risk of
injury, incorrect diagnosis, or ineffective
treatment; and (4) any changes to the
device would not be likely to result in
a change in the device’s classification.
These factors are relevant to
understanding whether a premarket
notification is necessary to assure the
safety and effectiveness of a device.
FDA has consistently used them since
1998, when section 510(m) was first
enacted. However, these factors were
not considered as part of the January 15,
2021, Notice. As mentioned above, the
January 15, 2021, Notice only
considered one piece of information—
MAUDE data—which is a drastically
narrower approach to the evaluation of
whether a device should be exempt than
the factors FDA has consistently
considered.
It was also an error for HHS to
propose to exempt the unclassified
device type with product code LXV
from the premarket notification
requirements. Unclassified devices
require submission of a 510(k)
premarket notification. The January 15,
2021, Notice proposes to exempt this
unclassified device type from 510(k)
under the process and standard of
510(m). Section 510(m), however,
provides only for the exemption of class
II devices. Unclassified devices are not
class II devices. Therefore, 510(m) does
not provide the standard or process for
exemption of unclassified devices. The
January 15, 2021, Notice did not cite to
any other statutory provision that
authorizes the exemption of unclassified
devices from 510(k).
As noted, the January 15, 2021, Notice
contained numerous errors and
ambiguities, such as mismatched
product descriptions, product codes,
and regulatory citations. For example,
table 6 in the Notice lists the 84 devices
it proposed to exempt. One entry gives
the Device description as ‘‘Oxygenator,
Long Term Support Greater than 6
Hours,’’ the Product code as ‘‘BZG,’’ and
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the section in 21 CFR as ‘‘868.1840.’’
The same table has a second listing for
‘‘Oxygenator, Long Term Support
Greater than 6 Hours,’’ this one giving
the Product code as ‘‘FXY’’ and the
section in 21 CFR as ‘‘878.4040.’’
However, ‘‘Oxygenator, Long Term
Support Greater than 6 Hours’’ is
Product code BYS and is classified in 21
CFR 870.4100. These errors and
ambiguities make it difficult or
impossible in some circumstances to
discern which class II devices the
Notice is proposing to exempt, as noted
by some commenters.
Finally, we did not find evidence that
HHS consulted with or otherwise
involved FDA in its proposed
exemption or the issuance of the
January 15, 2021, Notice. Section
1003(d) of the FD&C Act (21 U.S.C.
393(d)) provides that the Secretary
‘‘shall be responsible for executing’’ the
FD&C Act ‘‘through the [FDA]
Commissioner.’’ Here, the January 15,
2021, Notice is clearly an action
‘‘executing’’ the FD&C Act. Moreover, it
is particularly important that FDA have
at least some level of involvement in
this type of an action given the expertise
needed in evaluating whether a
submission under 510(k) of the FD&C
Act is necessary to assure the safety and
effectiveness of a device.
For these reasons, HHS and FDA are
withdrawing the proposed exemptions
of the 83 class II devices and 1
unclassified device published on
January 15, 2021, at 86 FR 4088.
Elsewhere in this issue of the Federal
Register, HHS and FDA are stating their
belief that the class I devices that are the
subject of the January 15, 2021, Notice
meet the criteria for reserved class I
devices and that it is appropriate to
reverse the determination of exemption
for those devices.
Dated: April 12, 2021.
Janet Woodcock,
Acting Commissioner of Food and Drugs.
Dated: April 12, 2021.
Xavier Becerra,
Secretary, Department of Health and Human
Services.
[FR Doc. 2021–07760 Filed 4–15–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
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20177
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; R25 and Fellowship
Application Review.
Date: April 26, 2021.
Time: 9:00 a.m. to 10:30 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: John F. Connaughton,
Ph.D., Chief, Scientific Review Officer,
Review Branch, DEA, NIDDK, National
Institutes of Health, Room 7007, 6707
Democracy Boulevard, Bethesda, MD 20892–
5452, (301) 594–7797, connaughtonj@
extra.niddk.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the urgent
need to meet timing limitations imposed by
the intramural research review cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: April 13, 2021.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–07888 Filed 4–15–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of
meetings of the National Advisory
Allergy and Infectious Diseases Council.
The meetings will be open to the
public as indicated below. The open
session will be videocast and can be
accessed from the NIH Videocasting and
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[Federal Register Volume 86, Number 72 (Friday, April 16, 2021)]
[Notices]
[Page 20177]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07888]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases;
Notice of Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Institute of Diabetes and Digestive
and Kidney Diseases Special Emphasis Panel; R25 and Fellowship
Application Review.
Date: April 26, 2021.
Time: 9:00 a.m. to 10:30 a.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Two Democracy Plaza, 6707
Democracy Boulevard, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: John F. Connaughton, Ph.D., Chief, Scientific
Review Officer, Review Branch, DEA, NIDDK, National Institutes of
Health, Room 7007, 6707 Democracy Boulevard, Bethesda, MD 20892-
5452, (301) 594-7797, [email protected].
This notice is being published less than 15 days prior to the
meeting due to the urgent need to meet timing limitations imposed by
the intramural research review cycle.
(Catalogue of Federal Domestic Assistance Program Nos. 93.847,
Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive
Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes of Health, HHS)
Dated: April 13, 2021.
Miguelina Perez,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2021-07888 Filed 4-15-21; 8:45 am]
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