Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals

CourtFood And Drug Administration,Health And Human Services Department
Citation87 FR 12175
Published date03 March 2022
Record Number2022-04409
12175
Federal Register / Vol. 87, No. 42 / Thursday, March 3, 2022 / Notices
received the proposal and notice of
opportunity for a hearing on November
8, 2021. Mr. Kuiper failed to request a
hearing within the timeframe prescribed
by regulation and has, therefore, waived
his opportunity for a hearing and
waived any contentions concerning his
debarment (21 CFR part 12).
II. Findings and Order
Therefore, the Assistant
Commissioner, Office of Human and
Animal Food Operations, under section
306(b)(3)(C) of the FD&C Act, under
authority delegated to the Assistant
Commissioner, finds that Mr. George
Kuiper has been convicted of felonies
under Federal law for conduct relating
to the importation into the United States
of any drug or controlled substance.
FDA finds that the offenses should be
accorded a debarment period of 5 years
as provided by section 306(c)(2)(A)(iii)
of the FD&C Act.
As a result of the foregoing finding,
Mr. Kuiper is debarred for a period of
5 years from importing or offering for
import any drug into the United States,
applicable (see
DATES
). Pursuant to
section 301(cc) of the FD&C Act (21
U.S.C. 331(cc)), the importing or
offering for import into the United
States of any drug or controlled
substance by, with the assistance of, or
at the direction of Mr. Kuiper is a
prohibited act.
Any application by Mr. Kuiper for
termination of debarment under section
306(d)(1) of the FD&C Act should be
identified with Docket No. FDA–2021–
N–0665 and sent to the Dockets
Management Staff (see
ADDRESSSES
).
The public availability of information in
these submissions is governed by 21
CFR 10.20(j).
Publicly available submissions will be
placed in the docket and will be
viewable at https://www.regulations.gov
or at the Dockets Management Staff (see
ADDRESSES
) between 9 a.m. and 4 p.m.,
Monday through Friday, 240–402–7500.
Dated: February 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–04484 Filed 3–2–22; 8:45 am]
BILLING CODE 4146–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2021–N–0918; FDA–
2018–N–1967; FDA–2009–D–0268; and
FDA–2019–N–3077]
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 or Agency) 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, 10A–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
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.
T
ABLE
1—L
IST OF
I
NFORMATION
C
OLLECTIONS
A
PPROVED
B
Y
OMB
Title of collection OMB control
No. Date approval
expires
Labeling Requirements for Human Prescription Drug and Biological Products ..................................................... 0910–0572 1/31/2025
Biosimilar User Fee Program .................................................................................................................................. 0910–0718 1/31/2025
Labeling of Certain Beers Subject to the Labeling Jurisdiction of the FDA ........................................................... 0910–0728 1/31/2025
Obtaining Information to Understand and Challenges and Opportunities Encountered by Compounding Out-
sourcing Facilities ................................................................................................................................................. 0910–0883 2/28/2025
Dated: February 23, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–04409 Filed 3–2–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–0117]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Authorization for
Medical Products for Use in
Emergencies
AGENCY
: Food and Drug Administration,
HHS.
ACTION
: Notice.
SUMMARY
: The Food and Drug
Administration (FDA, Agency, or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on information
collection associated with FDA
Authorization for Medical Products for
Use in Emergencies.
DATES
: Submit either electronic or
written comments on the collection of
information by May 2, 2022.
ADDRESSES
: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before May 2, 2022.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of May 2, 2022. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
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khammond on DSKJM1Z7X2PROD with NOTICES

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