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

• Published date: 03 March 2022
• Record Number: 2022-04409
• Section: Notices
• Court: Food And Drug Administration,Health And Human Services Department

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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