Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 74094 [2021-28299]
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74094
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
22:59 Dec 28, 2021
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
Frm 00032
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
]]>Agencies
[Federal Register Volume 86, Number 247 (Wednesday, December 29, 2021)]
[Notices]
[Page 74094]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-28299]
[[Page 74094]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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: Notice.
-----------------------------------------------------------------------
SUMMARY: 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,
[email protected].
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
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 Date approval
Title of collection number expires
------------------------------------------------------------------------
Request for Samples and Protocols....... 0910-0206 9/30/2024
Medical Device Recall Authority......... 0910-0432 9/30/2024
Survey on the Occurrence of Foodborne 0910-0799 9/30/2024
Illness Risk Factors in Selected
Institutional Foodservice and Retail
Food Stores Facility Types.............
Human Drug Compounding, Repackaging and 0910-0858 9/30/2024
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
