Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reclassification Petitions for Medical Devices, 74094-74095 [2021-28305]
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Federal Register / Vol. 86, No. 247 / Wednesday, December 29, 2021 / Notices
Food and Drug Administration
[Docket Nos. FDA–2002–N–0314; FDA–
2018–N–0405; FDA–2018–N–0270; and
FDA–2021–N–0359]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10 a.m.–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
following is a list of FDA information
SUMMARY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice.
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
number
Title of collection
Request for Samples and Protocols ........................................................................................................................
Medical Device Recall Authority ..............................................................................................................................
Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail
Food Stores Facility Types ..................................................................................................................................
Human Drug Compounding, Repackaging and Related Activities Regarding Sections 503A and 503B of the
Federal Food, Drug, and Cosmetic Act ...............................................................................................................
Dated: December 22, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–28299 Filed 12–28–21; 8:45 am]
BILLING CODE 4164–01–P782
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1529]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Reclassification
Petitions for Medical Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by January 28,
2022.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
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Jkt 256001
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0138. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Reclassification Petitions for Medical
Devices
OMB Control Number 0910–0138—
Extension
The Federal Food, Drug, and Cosmetic
Act (FD&C Act) establishes the
following three categories (classes) of
devices, reflecting the regulatory
controls needed to provide reasonable
assurance of their safety and
effectiveness: Class I (general controls),
class II (special controls), and class III
(premarket approval) (section 513(a)(1)
of the FD&C Act (21 U.S.C. 360c(a)(1)).
To change a device classification, FDA
can initiate a reclassification, or an
interested person can petition FDA to
reclassify a device based on new
PO 00000
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Fmt 4703
Sfmt 4703
Date approval
expires
0910–0206
0910–0432
9/30/2024
9/30/2024
0910–0799
9/30/2024
0910–0858
9/30/2024
information (section 513(e) of the FD&C
Act). On July 9, 2012, the Food and
Drug Administration Safety and
Innovation Act (FDASIA) was enacted,
changing the reclassification process
under section 513(e) of the FD&C Act
from rulemaking to an administrative
order process. To reclassify a device
under section 513(e) of the FD&C Act,
FDA must do the following before
making the reclassification final: (1)
Publish a proposed order in the Federal
Register that includes the proposed
reclassification and a summary of the
valid scientific evidence that supports
the reclassification, (2) convene a device
classification panel meeting, and (3)
consider comments from the relevant
public docket.
FDASIA also amended the provisions
of the FD&C Act authorizing FDA to
require submission of a premarket
approval application (PMA) for a
preamendments class III device (referred
to as a ‘‘call for PMAs’’).
Preamendments devices are devices that
were in commercial distribution before
the enactment of the 1976 Amendments.
Under the FD&C Act, preamendments
devices classified into class III may be
marketed upon clearance of a 510(k)
submission, and submission of a PMA is
not required until FDA has issued a
final order requiring premarket approval
(section 515(b) of the FD&C Act (21
U.S.C. 360e(b)). As amended by
FDASIA, the FD&C Act requires that
FDA, in its call for PMAs, publish a
proposed order in the Federal Register,
hold a classification panel meeting, and
E:\FR\FM\29DEN1.SGM
29DEN1
74095
Federal Register / Vol. 86, No. 247 / Wednesday, December 29, 2021 / Notices
consider comments on the proposed
order (section 515(b) of the FD&C Act,
as amended by FDASIA).
Under the FD&C Act, FDA’s call for
PMAs must, among other things,
contain an opportunity for interested
persons to request a change in the
classification of the device based on
new information (section 515(b)(2) of
the FD&C Act). After consideration of
comments on the proposed order and
findings, FDA must either: (1) Finalize
the call for PMAs by issuing an
administrative order requiring approval
of a PMA and publishing in the Federal
Register findings with respect to: (i) The
degree of risk of illness or injury
designed to be eliminated or reduced by
requiring the device to have an
approved PMA or a declared completed
product development protocol and (ii)
the benefit to the public from the use of
the device; or (2) publish a notice in the
Federal Register terminating the
proceeding and initiate a reclassification
proceeding based on new information
(section 515(b)(3) of the FD&C Act, as
amended by FDASIA; see section 513(e)
of the FD&C Act).
The FD&C Act, as amended by
FDASIA, now requires the use of
administrative orders, rather than
rulemaking, when FDA calls for PMAs
for a preamendments device remaining
in class III (section 515(b) of the FD&C
Act, as amended by FDASIA).
FDA refers to a device that was not in
commercial distribution before the 1976
Amendments as a postamendments
device. Postamendments devices are
classified automatically into class III by
statute, without any rulemaking process
(section 513(f)(1) of the FD&C Act). A
postamendments device remains in
class III and is subject to the PMA
requirements unless and until: (1) FDA
reclassifies the device into class I or II;
(2) FDA issues an order classifying the
device into class I or II via the De Novo
classification process (see section
513(f)(2) of the FD&C Act); or (3) FDA
issues an order finding the device to be
substantially equivalent to a predicate
device that does not require the filing of
a PMA (see section 513(i) of the FD&C
Act).
FDA may initiate, or the manufacturer
or importer of a device may petition for,
the reclassification of a
postamendments device classified into
class III by operation of law (section
513(f)(3) of the FD&C Act). This FDAinitiated reclassification process
consists of a proposed reclassification
order, optional panel consultation, and
a final reclassification order published
in the Federal Register following
consideration of comments and any
panel recommendations or comments
(§ 860.134(c) (21 CFR 860.134(c))). The
reclassification order may, as
appropriate, establish special controls to
provide reasonable assurance of the
safety and effectiveness of the device
(§ 860.134(d)).
Under the 1976 Amendments,
Congress classified all those devices
previously regulated as new drugs into
class III (generally referred to as
transitional devices). Under the FD&C
Act, FDA may initiate, or the
manufacturer or importer of a device
may petition for, the reclassification of
a transitional device remaining in class
III (section 520(l)(2) of the FD&C Act (21
U.S.C. 360j(l)(2)). The process for
reclassification of transitional devices
initiated by FDA is detailed in 21 CFR
?860.136(c). This process consists of a
proposed reclassification order, optional
panel consultation, and a final
reclassification order published in the
Federal Register following
consideration of comments and any
panel recommendations or comments.
In the Federal Register of September
7, 2021 (86 FR 50132), we published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
§ 860.123; supporting data for reclassification petitions ......
1 There
Number of
responses per
respondent
Number of
respondents
21 CFR section; information collection activity
6
1
6
Total hours
497
2,982
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
Dated: December 22, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–28305 Filed 12–28–21; 8:45 am]
BILLING CODE 4164–01–P917
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
[OMB No. 0906–0066—Extension]
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request SHIP COVID–19
Testing and Mitigation Program Data
Collection
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
khammond on DSKJM1Z7X2PROD with NOTICES
Average
burden per
response
Total annual
responses
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
SUMMARY:
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20:20 Dec 28, 2021
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PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
Comments on this ICR should be
received no later than February 28,
2022.
DATES:
Submit your comments to
paperwork@hrsa.gov or by mail to the
HRSA Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
ADDRESSES:
To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Samantha Miller, the acting
HRSA Information Collection Clearance
Officer at (301) 443–9094.
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\29DEN1.SGM
29DEN1
]]>Agencies
[Federal Register Volume 86, Number 247 (Wednesday, December 29, 2021)]
[Notices]
[Pages 74094-74095]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-28305]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1529]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Reclassification
Petitions for Medical Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by January 28, 2022.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0138. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Reclassification Petitions for Medical Devices
OMB Control Number 0910-0138--Extension
The Federal Food, Drug, and Cosmetic Act (FD&C Act) establishes the
following three categories (classes) of devices, reflecting the
regulatory controls needed to provide reasonable assurance of their
safety and effectiveness: Class I (general controls), class II (special
controls), and class III (premarket approval) (section 513(a)(1) of the
FD&C Act (21 U.S.C. 360c(a)(1)). To change a device classification, FDA
can initiate a reclassification, or an interested person can petition
FDA to reclassify a device based on new information (section 513(e) of
the FD&C Act). On July 9, 2012, the Food and Drug Administration Safety
and Innovation Act (FDASIA) was enacted, changing the reclassification
process under section 513(e) of the FD&C Act from rulemaking to an
administrative order process. To reclassify a device under section
513(e) of the FD&C Act, FDA must do the following before making the
reclassification final: (1) Publish a proposed order in the Federal
Register that includes the proposed reclassification and a summary of
the valid scientific evidence that supports the reclassification, (2)
convene a device classification panel meeting, and (3) consider
comments from the relevant public docket.
FDASIA also amended the provisions of the FD&C Act authorizing FDA
to require submission of a premarket approval application (PMA) for a
preamendments class III device (referred to as a ``call for PMAs'').
Preamendments devices are devices that were in commercial distribution
before the enactment of the 1976 Amendments. Under the FD&C Act,
preamendments devices classified into class III may be marketed upon
clearance of a 510(k) submission, and submission of a PMA is not
required until FDA has issued a final order requiring premarket
approval (section 515(b) of the FD&C Act (21 U.S.C. 360e(b)). As
amended by FDASIA, the FD&C Act requires that FDA, in its call for
PMAs, publish a proposed order in the Federal Register, hold a
classification panel meeting, and
[[Page 74095]]
consider comments on the proposed order (section 515(b) of the FD&C
Act, as amended by FDASIA).
Under the FD&C Act, FDA's call for PMAs must, among other things,
contain an opportunity for interested persons to request a change in
the classification of the device based on new information (section
515(b)(2) of the FD&C Act). After consideration of comments on the
proposed order and findings, FDA must either: (1) Finalize the call for
PMAs by issuing an administrative order requiring approval of a PMA and
publishing in the Federal Register findings with respect to: (i) The
degree of risk of illness or injury designed to be eliminated or
reduced by requiring the device to have an approved PMA or a declared
completed product development protocol and (ii) the benefit to the
public from the use of the device; or (2) publish a notice in the
Federal Register terminating the proceeding and initiate a
reclassification proceeding based on new information (section 515(b)(3)
of the FD&C Act, as amended by FDASIA; see section 513(e) of the FD&C
Act).
The FD&C Act, as amended by FDASIA, now requires the use of
administrative orders, rather than rulemaking, when FDA calls for PMAs
for a preamendments device remaining in class III (section 515(b) of
the FD&C Act, as amended by FDASIA).
FDA refers to a device that was not in commercial distribution
before the 1976 Amendments as a postamendments device. Postamendments
devices are classified automatically into class III by statute, without
any rulemaking process (section 513(f)(1) of the FD&C Act). A
postamendments device remains in class III and is subject to the PMA
requirements unless and until: (1) FDA reclassifies the device into
class I or II; (2) FDA issues an order classifying the device into
class I or II via the De Novo classification process (see section
513(f)(2) of the FD&C Act); or (3) FDA issues an order finding the
device to be substantially equivalent to a predicate device that does
not require the filing of a PMA (see section 513(i) of the FD&C Act).
FDA may initiate, or the manufacturer or importer of a device may
petition for, the reclassification of a postamendments device
classified into class III by operation of law (section 513(f)(3) of the
FD&C Act). This FDA-initiated reclassification process consists of a
proposed reclassification order, optional panel consultation, and a
final reclassification order published in the Federal Register
following consideration of comments and any panel recommendations or
comments (Sec. 860.134(c) (21 CFR 860.134(c))). The reclassification
order may, as appropriate, establish special controls to provide
reasonable assurance of the safety and effectiveness of the device
(Sec. 860.134(d)).
Under the 1976 Amendments, Congress classified all those devices
previously regulated as new drugs into class III (generally referred to
as transitional devices). Under the FD&C Act, FDA may initiate, or the
manufacturer or importer of a device may petition for, the
reclassification of a transitional device remaining in class III
(section 520(l)(2) of the FD&C Act (21 U.S.C. 360j(l)(2)). The process
for reclassification of transitional devices initiated by FDA is
detailed in 21 CFR ?860.136(c). This process consists of a proposed
reclassification order, optional panel consultation, and a final
reclassification order published in the Federal Register following
consideration of comments and any panel recommendations or comments.
In the Federal Register of September 7, 2021 (86 FR 50132), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR section; information Number of responses per Total annual burden per Total hours
collection activity respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Sec. 860.123; supporting data 6 1 6 497 2,982
for reclassification petitions.
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: December 22, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-28305 Filed 12-28-21; 8:45 am]
BILLING CODE 4164-01-P917
